The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Devices that were not introduced or delivered for introduction into interstate commerce for commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until (1) the Food and Drug Administration (FDA, the Agency, or we) reclassifies the device into class I or class II; or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of the procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and our implementing regulations (part 807, subpart E (21 CFR part 807, subpart E)).

A postamendments device that has been initially classified into class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

FDA relies upon “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies generally must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA) (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c))). Section 520(h)(4) of the FD&C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of the device, but it does not include the descriptions of methods of manufacture and product composition and other trade secrets.

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

On June 30, 2022, FDA published a proposed order  1 in the Federal Register to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers (product codes OYD and ONV, respectively) from class III to class II subject to premarket notification (87 FR 39025, the “proposed order”). 2 FDA has considered the information available to the Agency, including the deliberations of the General and Plastic Surgery Devices Advisory Panel convened on July 28-29, 2022 (the “Panel”) to discuss software-aided  3 adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer and the proposed reclassification (as discussed in section II of this document), as well as comments from the public docket on the proposed order (as discussed in section III of this document), to determine that there is sufficient information to establish special controls to effectively mitigate the risks to health (updated as discussed in section IV of this document). FDA has also determined based on this information that the special controls, together with general controls, provide a reasonable assurance of safety and effectiveness when applied to these devices.

Therefore, in accordance with section 513(f)(3) of the FD&C Act, FDA, on its own initiative, is issuing this final order to reclassify software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer from class III to class II (special controls). 4 Absent the special controls identified in this final order, general controls applicable to the device type are insufficient to effectively mitigate the risks identified for this device type, such as the risk of incorrect or delayed diagnosis of skin cancer from false negative results, and therefore insufficient to provide reasonable assurance of the safety and effectiveness of these devices. FDA expects that the reclassification of these devices will enable more manufacturers to develop these types of devices such that patients will benefit from increased access to adjunctive diagnostics for which there is a reasonable assurance of safety and effectiveness.

For these class II devices, instead of a PMA, manufacturers may submit a premarket notification and obtain FDA clearance of the devices before marketing them. This action will decrease regulatory burden on industry, as manufacturers will no longer have to submit a PMA for these types of devices but can instead submit a 510(k) to the Agency for review prior to marketing their device. A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately provides patients with more timely access to these types of devices.

On July 28, 2022, the Panel met to discuss the general topic of skin lesion analyzer technology and its application to detecting skin cancers in various patient care settings (the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer was discussed on the second day of the Panel meeting, as described later in this section). The Panel members were asked questions regarding the diagnosing standard, or ground truth, used to confirm lesion diagnosis in clinical testing of device accuracy; the acceptable sensitivity and specificity thresholds for different diagnoses and users; and patient characteristic considerations based on variable incidence of skin lesions in the U.S. population (Ref. 1).

The Panel generally advised that the diagnostic standard, or ground truth, for algorithm validation studies should be histological diagnosis, while some Panel members believed alternative approaches could be valuable depending on lesion type (such as consensus of a group of experts in certain benign lesion cases).

The Panel advised that the applicable thresholds for performance criteria, such as sensitivity and specificity, should be evaluated for specific skin lesion types ( e.g., melanoma, basal cell carcinoma, and squamous cell carcinoma), intended users ( e.g., dermatologist, primary care physician, lay user), and device type, and should show that the device improves the performance of the clinical user or improves patient outcomes ( i.e., earlier diagnosis). The Panel also discussed that the sensitivity and specificity threshold should be higher for standalone devices compared to devices intended for adjunctive use. Some Panel members commented on the importance of prospective data or post-market surveillance of real-world use to confirm device benefit. The Panel agreed that the selection of performance thresholds should take into account not only the risks of false negatives but also the risks of false positives, including psychological impacts and other effects.

Regarding patient characteristics that should be evaluated in clinical testing, the Panel advised that all patient skin phototypes should be studied with some flexibility in the data collection for low-incidence populations, such as by balancing premarket data with post-market study requirements and requiring transparency in the demographics and prevalence data in the studied populations.

On July 29, 2022, the Panel met to discuss and make recommendations regarding the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer from class III to class II (Ref. 1). In particular, the Panel discussed the proposed reclassification of MelaFind, a device that uses multispectral imaging and that was approved by FDA in 2011 (PMA P090012) (Ref. 2). The Panel also discussed the proposed reclassification of Nevisense, a device that measures electrical impedance and that was approved by FDA in 2017 (PMA P150046) (Ref. 3). Both MelaFind and Nevisense are intended for use on cutaneous lesions suspicious for skin cancer when a dermatologist chooses to obtain additional information when considering biopsy. At the Panel meeting, FDA presented the risks, mitigations, and special controls identified in the proposed reclassification order for a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.

The Panel agreed with inclusion of the risks identified by FDA, but suggested additional risks be included, as detailed in section II.B.1.

The Panel agreed that general controls alone are not sufficient to provide a reasonable assurance of safety and effectiveness for this device type. The Panel had varying opinions on whether the devices are life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, and whether or not these devices present a “potential unreasonable risk of illness or injury” considering, among other factors, that the devices are intended to be used adjunctively to standard of care but, in the opinion of some Panel members, have a potentially high risk associated with false negative output.

Some Panel members agreed that sufficient information exists to establish special controls for this device type, though most Panel members disagreed, suggesting more information is needed to understand device performance and device benefits and risks in real-world use. Several Panel members recommended additional clarity or detail in the proposed special controls. Some believed that FDA's proposed special controls were appropriate but not sufficient, recommending additional controls such as requirements for post-market surveillance, metrics to evaluate patient benefits and risks in addition to sensitivity and specificity, evaluation of specific patient populations and subtypes, prospective real-world use studies, and transparency regarding algorithm development. Various Panel members believed that this device type should not be reclassified from class III to class II.

FDA's responses to the recommendations of the Panel deliberations are detailed in this section. As discussed in section III, FDA also considered comments that were received from industry members, professional societies, and other interested parties in developing this final order. However, here in section II, we specifically address the Panel recommendations and FDA's responses.

The Panel suggested that additional risks to health presented by software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer be included in FDA's overall assessment of the risks to health, such as device bias in different populations, psychological impact of false positives and false negatives, risks associated with specific locations of device use, risks associated with inadequate user training, and risks associated with algorithm performance drift in real-world use.

FDA recognizes the potential psychological impact of inaccurate device output and considers this to be encompassed within the risks of false negative results, false positive results, use error or improper device use, and device failure or malfunction listed in table 1. FDA also agrees that there are risks associated with inadequate user training and considers these to be included in the risks of false negative results, false positive results, and use error or improper device use listed in table 1.

FDA agrees that devices may perform differently in different patient sub-populations due to several factors, including bias in training, tuning, and/or validation datasets. Likewise, FDA agrees that device use on different anatomical locations may result in different device performance. FDA considers these sources of performance variability to be encompassed within the risks of false negative results and false positive results listed in table 1. In response to the Panel discussion, FDA has made several additions to the special controls regarding clinical performance testing and labeling to mitigate these specific sources of performance variability and their contribution to device risk. These additions include requiring that clinical testing evaluate patients across risk factors that represent the intended patient population, including age, body site, skin phototype, and other clinical factors as applicable; requiring that labeling include a description of the patient population that was used in development or training of the device algorithm; and requiring that labeling include information related to the limitations of device performance or subpopulations for which the device may not perform as expected or for whom the device has not been validated.

Some Panel members also emphasized that interference with implants could pose risks to patients, including device interference that affects the implant performance, or interference of the implant that affects the device performance. FDA agrees, and notes that the risk of interference with other devices, including implants, was included among the risks to health identified in the proposed order (87 FR 39025). FDA also considers these risks to be encompassed within the risks of false negative results, false positive results, and device failure or malfunction listed in table 1.

Regarding the Panel's comments on algorithm performance drift in real-world use, FDA notes that MelaFind and Nevisense have fixed algorithms which do not change or adapt over time or with exposure to lesions during clinical use. Devices with algorithms other than fixed algorithms would represent a change in technology from the existing devices, and would very likely raise different questions of safety and effectiveness than the predicate device, which would preclude a finding of substantial equivalence under 21 CFR 807.100(b). Such devices would need to be evaluated according to 21 CFR 807.100(b)(2) to determine whether such a device could be found substantially equivalent to a predicate device within this classification regulation.

In addition, when a manufacturer of a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer that has been cleared by FDA intentionally changes the algorithm of its device, FDA would review the change in a premarket submission if the change exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k). FDA acknowledges that the device-aided user's accuracy may change over time or may differ from that demonstrated in premarket clinical studies with a retrospective design. FDA considers risks to health related to the accuracy of the device-aided user to be encompassed within the risk to health of false results due to use error or improper device use listed in table 1. In response to the Panel discussion, FDA has made several additions to the special controls regarding clinical performance testing to mitigate these risks to health. These additional special controls include requiring data obtained from both premarket clinical performance validation testing and post-market surveillance acquired under anticipated conditions of use, unless FDA determines based on the totality of the premarket data that data from post-market surveillance is not required.

FDA appreciates the perspective of various Panel members that more information is necessary to understand the device performance and its benefits and risks in real-world use. However, FDA believes that sufficient information exists and is available to FDA through the MelaFind PMA and associated panel considerations of that PMA, 5 published peer-reviewed literature (as discussed in the proposed order (87 FR 39025)), 6 and information collected from FDA's publicly available Medical Device Report (MDR) database, Manufacturer and User Facility Device Experience (MAUDE) database, and Medical Device Recall database since this device type was first introduced to the market, to understand the benefits and risks of this device type and establish special controls that effectively mitigate those risks. FDA reviewed certain real-world data, as discussed above, and does not agree that additional data from real-world use is necessary prior to establishing special controls (we note that data from real-world use is not a prerequisite to establishing special controls), or that special controls cannot be established based on current information, particularly as the intended use of the devices is limited to adjunctive use (rather than standalone use, which would present greater risks). For example, in response to feedback from the Panel, the special controls have been revised to require a high sensitivity (>90 percent for lesions with high metastatic potential, or a clinically justified alternative), which can effectively mitigate the risk of false negatives. See section IV for additional discussion of the mitigation measures for the risks to health identified for this device type. Some of the panel's concerns regarding real-world use appeared to relate to uncertainty about adaptive algorithms, but as noted above, devices with algorithms other than fixed algorithms are very likely to raise different questions of safety and effectiveness from the devices being reclassified here. In addition, to the extent there is concern about FDA relying on data from only two authorized devices, FDA notes that the statute contemplates that data from just one device could provide sufficient information to establish special controls for a device type under the de novo provisions (see 21 U.S.C. 360c(f)(2)).

In addition, although FDA appreciates that this technology may continue to evolve, the potential for such evolution does not suggest that there is insufficient information to establish special controls for the current device type. Future devices would only fall within this device type, and thus be classified into class II subject to the special controls established in this final order, if the device is found to be “substantially equivalent” to a predicate software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, which requires that the device have the same intended use and the same technological characteristics as the predicate device, or, if the device has different technological characteristics, the device must be as safe and effective as a legally marketed device and not raise different questions of safety and effectiveness. A future device that raises different questions of safety or effectiveness would not fall within the device type being reclassified into class II in this final order.

As noted in section II.B.1, FDA has made several additions to the clinical performance testing and labeling special controls in response to the deliberations of the Panel. FDA has also revised and added other special controls in response to recommendations from the Panel.

The Panel stated concerns regarding potential differences in device performance as observed in retrospectively designed premarket studies versus real-world device use. To partially address this concern, the revised special controls require data obtained from both premarket clinical performance validation testing and post-market surveillance acquired under anticipated conditions of use, unless FDA determines based on the totality of the premarket data that data from post-market surveillance is not required. The post-market surveillance data may provide additional information regarding device performance in the overall patient population, as well as in low-incidence patient sub-populations for whom relatively limited data was available at the time of premarket review.

As identified in the proposed order, and consistent with the recommendations of the Panel, the special controls allow for flexibility in the endpoints used to demonstrate patient benefits and risks in addition to sensitivity and specificity. The revised special controls require demonstration of “superior accuracy” of device-aided users' diagnostic characterization of the indicated lesions compared to the accuracy of unaided users, but do not specify a particular endpoint that must be used to evaluate accuracy. Additionally, to mitigate the high risk of false negatives identified by the Panel, the revised special controls require standalone device performance testing to demonstrate at least 90 percent sensitivity of the device output for lesions with high metastatic potential, or an alternative clinical consideration must be provided to justify lower sensitivity. The special controls also require that clinical justification be provided for the reported specificity. In addition, consistent with Panel feedback that applicable thresholds for performance criteria are dependent, in part, on the intended user, the labeling special controls require statements that the device is intended to be used by a physician trained in the clinical diagnosis and management of skin cancer ( e.g., a dermatologist) and that the device is not intended for use as a standalone diagnostic.

FDA agrees with the Panel recommendation that device evaluation should consider specific patient populations and lesion subtypes. The revised special controls require clinical testing and standalone testing to evaluate patients across risk factors (including age, body site, skin phototype, and other clinical factors as applicable) that represent the intended patient population. Analysis of standalone performance must include subgroup analysis by relevant risk factors. Moreover, and in response to the Panel's feedback regarding transparency, the revised special controls require device labeling to include a description of the patient population that was used in development or training of the device algorithm. The labeling must also include a summary of the standalone and clinical performance testing conducted with the device, including performance of the device for all clinically relevant subgroups within the intended patient population, and information related to the limitations of device performance or subpopulations for which the device may not perform as expected or for whom the device has not been validated.

FDA believes that these labeling special controls, along with other special controls such as those requiring human factors testing, device precision testing, the inclusion of information about device outputs in device labeling, and the inclusion of information about user qualifications in device labeling, will help to mitigate the risk of false results due to use error and changes in performance of the device in real-world use.

Under section 513(a)(1)(C) of the FD&C Act (21 U.S.C. 360c(a)(1)(C)), class III devices are those devices for which, among other things, insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness. In contrast, under section 513(a)(1)(B) of the FD&C Act, class II devices are those which cannot be classified into class I because general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, but for which there is sufficient information to establish special controls to provide such assurance. FDA agrees with the Panel members that general controls are not sufficient to provide reasonable assurance of the safety and effectiveness of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. However, as noted above, FDA believes that sufficient information exists and is available to FDA through the MelaFind PMA and associated panel considerations of that PMA, published peer-reviewed literature, and FDA's publicly available MDR database, MAUDE database, and Medical Device Recall database to establish special controls that effectively mitigate the risks to health identified for this device type. Accordingly, FDA has determined that software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should be reclassified from class III to class II.

FDA received comments from more than 50 commenters on the proposed order (87 FR 39025) published in the Federal Register on June 30, 2022, and for the subsequent Panel meeting held on July 28-29, 2022. The comment period on the proposed order closed on August 29, 2022, and the docket for the Panel meeting also closed on August 29, 2022. The majority of the comments received by the close of the comment periods were from individual medical professionals. Professional societies and members of the medical device industry also provided comments. Some of the comments contained one or more comments on one or more issues. We received comments providing support for the proposed reclassification as well as comments recommending against the proposed reclassification. Many comments also included technical considerations for assessing the safety and effectiveness of the devices subject to the proposed reclassification.

We describe and respond to the comments in section III.B of this document. The order of the comments and our response to them is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. Certain comments are grouped together under a single number because the subject matter is similar. Please note that in some cases we separated different issues discussed by the same commenter and designate them as distinct comments for purposes of our responses.

(Comment 1) Multiple comments supported the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. Commenters stated that reclassification into class II would be appropriate based on the device risks, that reclassification would support patient access to dermatological care, and that special controls could be established to provide a reasonable assurance of safety and effectiveness, with some commenters emphasizing the need to communicate risks due to false positives or false negatives. One commenter stated that there has been widespread use of physician adjunctive-use skin lesion analyzers in Europe for several years and the commenter was unaware of any meaningful negative impacts associated with such use. Many commenters also specified that reclassification of these devices into class II would be appropriate as these devices are intended to provide adjunctive information, not intended for use as standalone diagnostic devices. Some of these commenters also expressed that it would be appropriate to use these devices for general screening or triage.

(Response 1) FDA agrees with the comments supporting reclassification. Based on the available information, as discussed in the proposed order and in section II of this document, and in consideration of the comments received on the proposed order and the Panel meeting, FDA has determined that reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer into class II is appropriate. FDA made this determination because there is sufficient information to establish special controls that together with general controls will provide a reasonable assurance of safety and effectiveness for these devices when used adjunctively by physicians trained in the diagnosis and management of skin cancer (including requirements that the device labeling provide information regarding performance measures, including sensitivity, specificity and statistical confidence intervals, and an identification of risks associated with misinterpretation of the device outputs).

FDA also agrees with the comments that state that reclassification is appropriate based on the intended use of these devices to provide adjunctive information to aid in the evaluation of lesions suspicious for skin cancer following identification of a suspicious skin lesion, and not as a standalone diagnostic or for use to confirm a clinical diagnosis. Based on the totality of information available, FDA believes that general controls and special controls can provide a reasonable assurance of safety and effectiveness for these devices when they are intended to provide adjunctive information, not a diagnosis, and the intended users are physicians trained in the diagnosis and management of skin cancer. However, use of these devices as general screening tools or for triage falls outside the approved intended uses for the devices being reclassified, and hence is outside the scope of this final order. FDA would need additional data and information to address those uses.

The Agency believes that reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer under this final order will increase access to devices for which there is a reasonable assurance of safety and effectiveness by reducing the regulatory burden on manufacturers, while still providing reasonable assurance of safety and effectiveness. Specifically, reclassifying this type of device from class III into class II will reduce regulatory burdens on industry because instead of submitting a PMA, manufacturers may submit a less burdensome 510(k) to obtain FDA clearance of the device before marketing it. The Agency also agrees with commenters that this reclassification may have a positive impact on dermatological care.

(Comment 2) Multiple comments disagreed with the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. Some commenters stated that it would be inappropriate, difficult, or impossible to develop a uniform non-clinical and clinical testing paradigm that can be applied to every device of this type. Some commenters expressed concern that reclassification would reduce FDA's ability to provide input on non-clinical or clinical study design. Many commenters also indicated that each specific device should be assessed to ensure appropriate device performance and clinical validity catered to the device's specific technological characteristics, intended users, and lesion types, and that these devices should be maintained in class III to maintain the strictest level of FDA premarket review of device safety, performance, and labeling. Some commenters stated that there is not sufficient information or experience with this device type to support reclassification and the establishment of special controls to provide a reasonable assurance of safety and effectiveness, or that the consequences of an inaccurate diagnosis could result in unnecessary procedures (such as biopsies and surgeries) or are too severe to support reclassification.

(Response 2) FDA disagrees that reclassification would be inappropriate based on the need for device-specific non-clinical and clinical assessments or premarket review for the specific device. FDA agrees that a uniform approach to non-clinical and clinical performance testing is not appropriate for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, and there is no single clinical study design that would be appropriate for all devices of this type. The special controls for this device type outlined in this final order include controls for non-clinical and clinical testing that could support unique study designs that are appropriate for the specific indications for use and technological characteristics for each device that would be reviewed in a premarket notification. While every clinical study developed to support a premarket submission for a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should be designed to demonstrate that the device performs as intended when used by the intended user in the intended patient population, the final special controls for these devices allow for customized study designs tailored specifically for each device considering the device technology and indications for use. Reclassification of these devices from class III to class II does not exclude device-specific non-clinical and clinical testing. Rather, the special controls establish requirements for non-clinical and clinical testing that is necessary to support reasonable assurance of safety and effectiveness for the device. The substantial equivalence framework in the 510(k) review paradigm permits potential clearance of devices of the same device type even when supported by data from different types of studies, consistent with FDA's least burdensome provisions. 7

FDA also agrees that these devices require appropriate regulatory oversight through premarket review, but disagrees that classification in class III and PMA approval is necessary to provide such oversight for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. For example, PMA approval requires, among other things, the submission of a complete description of the methods used in, and the facilities and controls used for, the manufacture, processing, packing, storage, and, where appropriate, installation of the device (21 CFR 814.20(b)(4)(v)), and FDA often conducts inspections prior to PMA approval. PMA requirements also include annual reporting requirements, and requirements regarding the submission and approval of PMA supplements. As discussed in more detail in response to Comment 8, FDA does not believe that compliance with such requirements is necessary to provide a reasonable assurance of safety and effectiveness for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. This final reclassification order establishes that instead of submission and approval of a PMA, submission and clearance of a 510(k) will be required prior to legally marketing these devices. FDA reviews the non-clinical and clinical data and related valid scientific evidence included in a 510(k) to assess substantial equivalence to a legally marketed predicate device, including, as appropriate, conformance to special controls. FDA will also evaluate device labeling to ensure that labeling is consistent with the labeling requirements established in the special controls. Clearance of a 510(k) reflects FDA's determination that the device has the same intended use and technological characteristics as the predicate, or, if the device has different technological characteristics, that the device is as safe and as effective as a legally marketed device and does not raise different questions of safety and effectiveness than the predicate device (see section 513(i) of the FD&C Act).

Additionally, some commenters expressed concern that reclassification would reduce FDA's ability to provide input on non-clinical or clinical study design. However, regardless of whether a device is classified in class III or class II, FDA may provide input on non-clinical or clinical study design. A manufacturer may seek FDA input on non-clinical or clinical study design by utilizing our Q-Submission program, through which FDA may provide input on device-specific requirements and recommendations for non-clinical and clinical studies intended to support device-specific indications for use. Additional information regarding the Q-Submission program can be found in FDA's final guidance document entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” (Ref. 4). In addition, reclassification does not change the regulatory requirements related to clinical study oversight and investigational device exemptions (IDEs). FDA may provide specific feedback and study design considerations for clinical trials as a part of IDE review for significant risk studies. The special controls also require that specific study design elements consider the indicated lesions, intended patient population, and intended users to provide a reasonable assurance of safety and effectiveness.

Ultimately, as discussed in section II.B.2 of this document, FDA believes there is sufficient information and experience available to support the reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer into class II, including sufficient information to establish special controls for these devices such that general controls and special controls together provide a reasonable assurance of safety and effectiveness. Considering the intended use of these devices as an adjunctive source of information for clinical decision making (rather than to provide a diagnosis), FDA believes these controls effectively mitigate the potential negative consequences of an incorrect diagnosis based on the adjunctive information from the device.

(Comment 3) Multiple comments disagreed with the proposed reclassification based on the concern that software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer may be used by the general public (as an over-the-counter device) or by other unqualified users to assess skin lesions (their own or others'), or based on the concern that these devices may be used as standalone diagnostic devices in the absence of a clinical assessment by a physician trained in the clinical diagnosis and management of skin cancer ( e.g., a dermatologist). Some of these commenters indicated that use by untrained users, including non-dermatologist medical providers and/or lay users, would likely increase the risk of device misuse and result in unacceptable rates of false positive and false negative results, leading to patient harm (such as delay in diagnosis of skin cancer and/or unnecessary procedures and patient anxiety) or increased demand for dermatological services. Commenters stated that diagnosis by a medical professional trained in the diagnosis and management of skin cancer is the gold standard for skin cancer diagnosis and that a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer is not a substitute for a clinician's diagnosis and histopathology.

(Response 3) FDA agrees that software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer are not a substitute for diagnosis of skin lesions by a trained clinician and would present different risks if intended for use by untrained users. The devices being reclassified in this final order are identified as being intended for prescription use only and for use by a physician trained in the clinical diagnosis and management of skin cancer ( e.g., a dermatologist) as an adjunctive device following identification of a suspicious skin lesion. These devices are not intended to be used by the general public or by medical personnel untrained in the clinical diagnosis and management of skin cancer, and are not intended for use as a standalone diagnostic or to confirm a clinical diagnosis.

FDA agrees that the expertise of a trained clinician is needed to appropriately select lesions for assessment consistent with the intended use and instructions for use for these devices, and consistent with the clinical studies that validate device performance. As such, the intended users of these devices are physicians trained in the clinical diagnosis and management of skin cancer. The clinical performance validation testing special controls require that lesions used in clinical testing must be selected by representative users ( e.g., dermatologists) and a justification must be provided for the quantity and range of mimic lesions per diagnosis, which is intended to ensure that the device works safely and effectively on the lesions that a user ( e.g., a dermatologist) would choose to use the device on. Additionally, the labeling special controls require that the labeling include a statement that the device is not intended for use as a standalone diagnostic and include the user qualifications needed for safe use of the device, including a description of required user training and a statement that the device is intended to be used by a physician trained in the clinical diagnosis and management of skin cancer.

(Comment 4) Some commenters stated that reclassified software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should include devices intended for use by non-specialists and by general practitioner care providers.

(Response 4) FDA disagrees with these comments and believes that physicians trained in the clinical diagnosis and management of skin cancer are the appropriate intended users of these devices based on the intended use, performance testing for the devices, and the expertise and training needed to utilize these devices as adjunctive sources of information for clinical decision making for suspicious skin lesions. This is consistent with the indications for use of approved software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer (see Refs. 2 and 3). While different types of skin lesion analyzers may have different intended users, 8 different users present different risks, and the Agency believes that the assessment of a clinician trained in the diagnosis and management of skin cancer is important for the safe and effective use of this device type.

(Comment 5) Several commenters provided feedback on what may be considered the ground truth as a comparator for device performance in clinical studies for a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. Other commenters provided feedback on what type of data should be considered as an input for these devices. These comments generally agreed that histologically confirmed diagnosis of biopsied tissue assessed by a trained dermatopathologist or a panel of trained dermatopathologists would be appropriate as a ground truth comparator for clinical studies, though one comment noted that biopsy of non-suspicious lesions may not be needed to establish ground truth in a clinical trial because a large number of benign lesions are already considered suspicious enough to biopsy and can be used to form a ground truth for benign lesions. Some commenters stated that dermoscopic images should be used as inputs for these devices, rather than standard images or other types of input data.

(Response 5) FDA agrees that in many cases, histologically confirmed diagnosis by a trained dermatopathologist or a panel of trained dermatopathologists provides an appropriate ground truth comparator for use in clinical studies of a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, though the exact source of information used in clinical trials as a comparator may be specific to each clinical trial design, including the range and number of suspicious and non-suspicious lesions sampled for the trial. FDA also believes that it is important to consider that, as technology and clinical practices evolve, additional comparators may be possible with appropriate justification and supportive valid scientific evidence. To that end, the clinical performance special controls include a requirement that justification must be provided for the determination of ground truth.

FDA also acknowledges that dermoscopic images may be used as inputs for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. However, we note that current devices utilize other types of inputs, including multispectral images or electrical impedance measurements, and as discussed elsewhere in this document, FDA has determined that general controls and the special controls established in this final order effectively mitigate the risks to health identified for these devices.

(Comment 6) Multiple comments provided input regarding statistical performance targets and study endpoints for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, including the extent to which such targets and endpoints should be specified in special controls. Generally, these comments indicated that sensitivity, specificity, accuracy, and other indicators of statistical performance and validity should be assured to be appropriate for each device based on the intended use and intended user, and that there is not a single set of statistical performance targets that would be appropriate for every device and every indication, though some commentators suggested that the special controls should include specific targets for statistical performance requirements. Some commenters emphasized the importance of ensuring that performance goals and study requirements are achievable for each type of study conducted to support device performance, and that use of a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should improve physicians' ability to detect skin cancer without causing an unacceptable increase in systemic care burden, particularly if the care burden is unnecessary biopsies.

Specific feedback regarding statistical performance included a recommendation that suitable studies of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should demonstrate sensitivity with a lower bound of the confidence interval greater than 90 percent. One commenter recommended that device sensitivity for the indicated skin cancer(s) should be superior to unaided providers in the study or in literature, and that the sum of device sensitivity and specificity should be greater than one to demonstrate that the device performance is statistically meaningful and is a beneficial adjunct to inform dermatologist decision making. Another commenter recommended that, ultimately, the primary effectiveness criterion should be that use of the device improves dermatologists' correct assessment of whether to biopsy a lesion suspicious for skin cancer.

(Response 6) FDA agrees that the device, when used by a provider trained in the diagnosis and management of skin cancer as an adjunctive device to aid in the evaluation of lesions suspicious for skin cancer following identification of a suspicious skin lesion, should enable superior accuracy in the provider's decision-making process for assessing skin lesions compared to unaided providers. FDA also agrees that the performance goals and study endpoints for clinical studies used to test these devices should be reasonable and achievable. The performance special controls established in this final order therefore include clinical testing with clinically justified endpoints for device sensitivity and specificity relative to ground truth for a representative range of individuals with different risk factors and a justified quantity and range of mimic lesions, which are benign skin lesions that are visually very similar to malignant lesions. Performance data must also demonstrate superior accuracy of device-aided users' diagnostic characterization of lesions compared to that of unaided users. For lesions with high metastatic potential, FDA believes that a sensitivity of at least 90 percent, or a clinically justified alternative, is necessary to mitigate the risks related to false negatives, and as such has established requirements in the special controls to that effect. Device specificity and other endpoints should be clinically justified and appropriate for the specific indications and labeling to mitigate the risks related to false positives, which may also reduce any potential increase in care burden such as from unnecessary biopsies.

(Comment 7) Multiple comments provided recommendations for study design considerations related to patient demographics and lesion selection. Specific recommendations included that there should be a sufficient number of subjects across multiple clinical sites in studies to allow for subgroup analysis. Demographic considerations recommended in these comments included ethnicity, sex, age, low/intermediate/high-risk populations, and Fitzpatrick skin type  9 of the intended patient population. Some comments noted that patients with darker Fitzpatrick skin types (IV-VI) are often underserved in dermatology and underrepresented in clinical studies related to assessing skin lesions; these comments supported that clinical trials should utilize investigational patient populations representative of the intended patient population of the device. Some comments further stated that software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer ought to be effective at assessing lesions in patients with darker Fitzpatrick skin types, while other comments stated that a phased approach to considering different skin types would be appropriate. One comment asserted that special controls addressing labeling may be used to minimize risk in underrepresented populations. Comments also recommended that a broad range of lesion types, sizes, and anatomic sites should be included in clinical studies. Additionally, commenters stated that the classification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should reflect the difference in risk associated with devices indicated for use for melanoma as compared to devices indicated for use for other types of lesions and skin cancers.

(Response 7) FDA believes that clinical studies supporting the safety and effectiveness of a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer should consider patient populations representative of the intended patient population for the device and a wide variety of lesions to support the specific indication(s) and intended patient population for the device. The special controls state that clinical testing must evaluate patients across risk factors (including age, body site, skin phototype, and other clinical factors as applicable) that represent the intended patient population and that analysis of standalone performance must include subgroup analysis by relevant risk factors to help demonstrate that the device performs as intended in the intended patient population. The special controls require both premarket clinical performance validation testing and post-market surveillance, in part to provide a reasonable assurance of safety and effectiveness in patients with relatively lower incidence of skin cancer, unless FDA determines based on the totality of the premarket data that data from post-market surveillance is not required. The clinical performance special controls also state that a justification must be provided for the quantity and range of mimic lesions per diagnosis used in testing, that data must demonstrate superior accuracy of device-aided users' diagnostic characterization of the indicated lesions compared to the accuracy of unaided users, and that testing must demonstrate at least 90 percent sensitivity of the device output for lesions with high metastatic potential (or an alternative clinical consideration must be provided to justify lower sensitivity), thereby contributing to the risk mitigation for higher risk types of skin cancers, and different types of skin cancers and lesions. The special controls established in this final order therefore mitigate the risk associated with use for different lesion types, including lesions with high metastatic potential such as melanoma.

Additionally, FDA agrees that labeling special controls, among the other special controls established in this final order, are necessary to provide a reasonable assurance of safety and effectiveness of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. The labeling special controls state that device labeling must include, among other things, information about device performance for all clinically relevant subgroups within the intended patient population(s), a description of the patient population that was used in development or training of the device algorithm, and information about subpopulations for which the device may not perform as expected or for whom the device has not been validated.

(Comment 8) Multiple comments stated that FDA should conduct premarket inspections and establish post-market requirements for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer including post-market surveillance studies, manufacturing facility inspections, and annual reports. One comment stated that databases should be maintained to help ensure the safety of patients on which software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer are used. Some commenters raised concerns regarding how future changes to device hardware or software, especially artificial intelligence and machine learning (AI/ML) algorithms, might be managed under the 510(k) paradigm and suggested that PMA annual reporting requirements or PMA supplement requirements may be the only way to provide appropriate oversight of such changes, and that such changes may need to be supported by additional clinical data. Another commenter supported the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer and suggested that special controls should require adequate documentation on AI/ML data management, training, and validation.

(Response 8) FDA agrees with parts of these comments. The special controls established in this final order include a requirement that data obtained from post-market surveillance demonstrate that the device performs as intended in the intended patient population and under anticipated conditions of use, unless FDA determines based on the totality of the premarket data that data from post-market surveillance is not required. For any such required post-market surveillance, FDA believes that to conduct the surveillance in a timely fashion, a manufacturer generally should submit a complete study protocol for the post-market surveillance study consistent with the special control requirements within 30 days of receipt of a 510(k) decision letter finding the device substantially equivalent to a predicate device. FDA generally expects to work with the manufacturer to approve the study protocol within 90 days of that letter. In addition, to ensure the surveillance is conducted in a timely fashion, FDA believes that from the date of protocol approval, the first study subject should generally be enrolled within 6 months; 20 percent of subjects should generally be enrolled within 12 months; 50 percent of subjects should generally be enrolled within 24 months; and 100 percent of subjects should generally be enrolled within 36 months. FDA also believes that manufacturers should generally submit post-market study progress reports every year until subject enrollment has been completed, and annually thereafter, from the date of the 510(k) decision letter; that if any enrollment milestones are not met, manufacturers should generally submit enrollment status reports every 6 months in addition to the annual post-market study progress reports, until FDA notifies the manufacturer otherwise; and that manufacturers should generally submit a final post-market study report 3 months from study completion ( i.e., last subject's last follow-up date). FDA anticipates that specific timelines may be discussed with the manufacturer at the time of and/or following receipt of the 510(k) decision letter.

FDA also maintains the MDR database, MAUDE database, and Medical Device Recall database, which allows for additional post-market surveillance of these devices and helps to ensure continued safety for marketed devices.

FDA does not agree that premarket site inspections are necessary to provide reasonable assurance of safety and effectiveness for these devices. There is a low risk of batch variability in the manufacturing of these devices, and the hardware of these devices can generally be characterized with well-established methods and standards. The special controls identified in this final order establish requirements for validating both software and hardware components of the devices premarket, including that testing must include a description of compatible hardware and processes, pre-specified compatibility testing protocols, and dataset(s). The special controls also establish requirements relating to device precision, electromagnetic compatibility, and electrical, mechanical, and thermal safety, biocompatibility, and software verification, validation, and hazard analysis. Additionally, routine or for-cause inspections, which may consider compliance with quality management system requirements  10 applicable to the manufacturing of the device, allow for post-market oversight of these devices with respect to inspections.

FDA also disagrees that the PMA annual reporting requirements (distinct from annual reporting associated with a post-market surveillance study) or PMA supplement requirements are necessary to ensure that changes to a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer that has received marketing authorization have appropriate oversight. Under the 510(k) paradigm, a new 510(k) is required for any change or modification to a cleared device that could significantly affect the safety or effectiveness of the device, or for a major change or modification in intended use. 11 Information on more minor changes, such as might be submitted in a PMA supplement or reported in a PMA periodic report, is not needed for reasonable assurance of safety and effectiveness here considering that the intended use of the devices being reclassified is limited to adjunctive use after a provider has identified a suspicious skin lesion and is not for use to confirm a clinical diagnosis, and because, as discussed in section IV, the special controls established in this final order, in addition to general controls, are sufficient to mitigate the risks to health that may be associated with the use of a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.

Additionally, manufacturers may wish to use predetermined change control plans (PCCPs) as a way to implement future modifications to their devices without needing to submit a new 510(k) for each significant change or modification  12 while continuing to provide a reasonable assurance of device safety and effectiveness. 13 FDA reviews a PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each significant change or modification described in the PCCP. When used appropriately, PCCPs authorized by FDA are expected to be least burdensome for manufacturers and FDA. 14

Based on all available information, including feedback from the July 2022 reclassification panel meeting, the Agency believes it likely that changes to the AI/ML algorithm in a software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer could significantly impact device effectiveness or safety. As such, these changes would likely require a new 510(k) (unless the changes are implemented consistent with a cleared PCCP), as would changes to device hardware (including signal capturing hardware), the device output, or other software aspects that could significantly impact device safety or effectiveness. Examples of such changes include expansion or modification of the AI/ML algorithm training data, modification to cut-off values or thresholds used to determine device output, and addition, removal, or modification of device outputs. It is important to note that the devices subject to this reclassification do not utilize adaptive algorithms ( i.e., algorithms that evolve dynamically due to continuous learning while they are used). FDA also notes that FDA's quality management system requirements include documentation requirements related to, among other things, device modifications and validation (see 21 CFR part 820).

FDA agrees that some changes to device software or hardware may require new clinical data, which may require premarket review within the context of a new premarket submission.

(Comment 9) Several comments expressed concerns related to layperson use of mobile phone-based software applications intended to provide information about or diagnose skin lesions. Commenters stated that these devices have different risks and may have greater risks than the software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer being reclassified in this order, and stated that such mobile phone-based software applications intended for use by lay persons should not be a part of this reclassification. Others expressed a concern that reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer might be interpreted as indicating an Agency position on layperson, mobile phone-based devices with similar intended uses. Some commenters provided input regarding requirements that should be established for mobile phone-based software applications intended for use by lay persons on skin lesions, such as that they should use digital dermoscopy images, not smartphone images.

(Response 9) FDA agrees that mobile phone-based or other web-based software applications intended for use by lay users to provide information about or diagnose skin lesions have different risks than the devices being reclassified in this final order. The devices subject to this reclassification order are not mobile phone or web-based applications available to lay users. At the time of publication of this final order, FDA has not classified, cleared, approved, or granted authorization for a layperson use mobile phone-based or web-based application intended to provide diagnostic or adjunctive information about skin lesions, and layperson, mobile phone-based or web-based devices are not within the scope of this final order. Comments related to the technological characteristics of mobile phone applications intended for use by lay users are outside the scope of this reclassification order.

(Comment 10) One comment stated that FDA's method of notifying the dermatologic community about the opportunity for public comment on the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer was inadequate, noting that certain interested persons were not informed that the topic was under discussion.

(Response 10) FDA disagrees that its method of informing interested persons of the opportunity for public comment on the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer was inadequate. FDA's procedures were conducted consistent with the Agency's regulations under 21 CFR 860.134 and section 513(f)(3) of the FD&C Act, including publication of a proposed order in the Federal Register (87 FR 39025), provision of a 60-day comment period for interested persons to submit comments to a public docket, and the convening of a meeting of the appropriate classification panel to discuss the proposed reclassification (including the establishment of an additional docket for public comment and opportunities for interested persons to attend and/or present data, information, or views at the Panel meeting). These procedures provided meaningful opportunity for public comment; FDA received comments from more than 50 commenters on the proposed order and Panel meeting, including comments from a variety of entities such as individual medical professionals, professional societies, and members of the medical device industry. FDA therefore believes that the Agency provided sufficient opportunity for interested parties to comment on the proposed reclassification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.

As described in sections II and III of this document, FDA has made revisions in this final order in response to feedback from the Panel and comments regarding the proposed reclassification order that were submitted to public dockets.

Based, in part, on the Panel feedback and comments regarding the proposed reclassification order, FDA has revised the list of risks to health associated with the use of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, the special controls that FDA has determined will mitigate these risks, and Table 1, “Risks to Health and Mitigation Measures for Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer”.

FDA has identified the following risks to health associated with the use of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer:

• False negative results or false positive results: False negative results could result in incorrect or delayed diagnoses and delays in skin cancer treatment. These delays may allow an undetected condition to worsen and potentially increase skin cancer associated morbidity and mortality. False positive results may result in complications such as incorrect management of the patient, including unnecessary invasive biopsy procedures and more frequent screenings, as well as the potential administration of inappropriate treatments and/or the withholding of appropriate treatments, with possible adverse effects.

• Use error or improper device use: Use error or improper device use could lead to false results or failure to generate a result. The device could be misused to analyze data from an unintended patient population, an unintended anatomical site, or lesions having an unintended attribute, or to analyze data acquired with incompatible hardware or incompatible acquisition settings, potentially resulting in the device not operating at its expected performance level. The device could also be misused if the user does not follow the appropriate use protocol for using the device to assess lesions of interest. Examples of not following the appropriate use protocol include overreliance on the device output or not using the device in an adjunctive manner, i.e., using the device output alone to make a patient management decision, which may lead to lower accuracy. Inaccurate results may result in the same complications associated with false negative or false positive results as previously discussed.

• Device failure or malfunction: Device failure or malfunction could result in the absence or delay of device output, or incorrect device output, which could lead to inaccurate patient assessment. Inaccurate results may result in the same complications associated with false negative or false positive results as previously discussed.

• Electrical, thermal, mechanical, or light exposure-related injury: While in operation, the device may discharge electricity that could shock the user or patient. Electrical discharge or exposure to device-generated heat may cause thermal injury or discomfort. Moving parts may cause mechanical injury. For devices that utilize energy ( e.g., light) to provide adjunctive diagnostic information, accidental eye exposure to the energy source could cause eye injury.

• Interference with other devices: Individuals with electrically powered implants could experience an adverse interaction with the device due to electromagnetic interference or radiofrequency interference.

• Adverse tissue reaction: A patient could experience skin irritation and/or allergic reaction associated with non-biocompatible materials in patient-contacting components of the device.

• Infection and cross contamination: If components of the device that must be sterile are not adequately sterilized or if reusable components are not adequately reprocessed ( i.e., are not cleaned and sterilized or disinfected) between uses, the device may introduce pathogenic organisms to patients which may result in an infection.

FDA has determined that the following special controls will mitigate these risks to health, and that these special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer:

• The risk of false negative results or false positive results can be mitigated through clinical performance testing—including standalone testing that demonstrates at least 90 percent sensitivity of the device output for lesions with high metastatic potential (or an alternative clinical consideration must be provided to justify lower sensitivity), and with a clinical justification provided for the reported specificity—as well as non-clinical performance testing and post-market surveillance (unless FDA determines based on the totality of the premarket data that data from post-market surveillance is not required). The clinical performance testing must demonstrate superior accuracy of device-aided users' diagnostic characterization of the indicated lesions compared to the accuracy of unaided users. The non-clinical performance testing, among other information, must demonstrate that the device performs as intended under anticipated conditions of use, including a description of compatible hardware and processes, pre-specified compatibility testing protocols, and dataset(s). In addition, post-market surveillance data may address potential differences in device performance as observed in retrospectively designed premarket studies versus real-world device use and provide additional information regarding device performance in the overall patient population, including in low-incidence patient sub-populations for whom relatively limited data was available at the time of premarket review. The risk of false positive results and false negative results can be further mitigated by special controls that require information in labeling to provide detailed instructions for use and inform the user of the expected device performance for all clinically relevant subgroups within the intended patient population.

• The risk associated with use error or improper device use can be mitigated by performance testing that demonstrates device precision, including repeatability and reproducibility of device performance, across operators and challenging use conditions. In addition, this risk can be mitigated by requiring that the device labeling include information regarding performance of the device for all clinically relevant subgroups within the intended patient population, as well as a description of the patient population that was used in development or training of the device algorithm. This risk can be further mitigated by special controls that require the device labeling to include information related to the limitations of device performance or subpopulations for which the device may not perform as expected or for whom the device has not been validated. The risk resulting from not following the device instructions for use can be mitigated by special controls that require a human factors assessment to demonstrate that intended users can correctly use the device according to the intended use. This risk can be further mitigated by requiring that the device labeling include information needed to facilitate interpretation of all device outputs and identification of the risks associated with misinterpretation of the device outputs, and by special controls requiring that the device labeling provide a description of user training required prior to use and a statement that the device is not intended for use as a standalone diagnostic.

• The risk of device failure or malfunction can be mitigated by requiring non-clinical performance testing and software verification, validation, and hazard analysis, and by requiring performance testing that demonstrates device precision, including repeatability and reproducibility of device performance, across operators and challenging use conditions. This risk can be further mitigated by requiring that instructions for device maintenance and validated methods and instructions for reprocessing of any reusable components be included in the labeling.

• The risk of electrical, thermal, mechanical or light-related hazards leading to user injury or discomfort can be mitigated by special controls that require testing that demonstrates electrical, mechanical, and thermal safety; software verification, validation and hazard analysis; and device labeling that includes instructions on appropriate usage and maintenance of the device. The risk of eye injury due to energy ( e.g., light) exposure can be mitigated by special controls that require labeling that warns users about exclusion of lesions close to the eye and unsafe exposure to any energy-emitting components of the device.

• The risk that the device may interfere with other devices due to radiofrequency or electromagnetic interference can be mitigated by requiring testing that demonstrates electromagnetic compatibility.

• The risk of adverse tissue reaction for patient-contacting devices can be mitigated by special controls that require elements of the device that may contact the patient to be demonstrated to be biocompatible and labeling that includes, in addition to user qualifications needed for safe use of the device, instructions for device maintenance and validated methods and instructions for reprocessing of any reusable components.

• The risks of infection and cross contamination for patient-contacting components can be mitigated by special controls that require sterilization validation, shelf-life testing, and labeling that includes validated methods and instructions for reprocessing of any reusable components ( i.e., cleaning and sterilization or disinfection).

In this final order, FDA is adopting relevant findings from the June 30, 2022, proposed order (87 FR 39025). FDA has made revisions in this final order in response to the Panel deliberations (see section II) and comments received (see section III). FDA is issuing this final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III into class II under a new device classification regulation with the name software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, and to establish special controls by revising 21 CFR part 878 (adding 21 CFR 878.1820). The identification for § 878.1820(a)(1) has been revised to provide a more accurate description of the devices in this classification regulation.

Further, in this final order, FDA has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, along with general controls, provide a reasonable assurance of the safety and effectiveness for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. In this final order, the Agency has made refinements to the special controls as previously described in the proposed order to further mitigate the risks to health associated with the use of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer. Specifically, and among other things, FDA added new special controls requiring that data from post-market surveillance demonstrate that the device performs as intended in the intended patient population and under anticipated conditions of use (unless FDA determines based on the totality of the premarket data that data from post-market surveillance is not required); requiring that standalone testing demonstrate at least 90 percent sensitivity of the device output for lesions with high metastatic potential (or an alternative clinical consideration must be provided to justify lower sensitivity), and that a clinical justification be provided for the reported specificity; requiring that clinical testing evaluate patients across risk factors that represent the intended patient population, including age, body site, skin phototype, and other clinical factors as applicable; requiring that performance testing demonstrate device precision, including repeatability and reproducibility of device performance, across operators and challenging use conditions; and requiring that labeling include a description of the patient population that was used in development or training of the device algorithm.

Under the FD&C Act, 510(k) submissions are required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m). 15 FDA has not made this determination for software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer and, therefore, this class II device type is not exempt from 510(k) requirements. Thus, under sections 510(k) and 513(f) of the FD&C Act, persons who intend to market this device type must submit a 510(k) containing information on the software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer that they intend to market and must obtain FDA clearance of the device prior to marketing it.

Under this final order, software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer are prescription use devices under § 801.109 (21 CFR 801.109). 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 § 801.109 are met. The device would continue to be subject to the submission and device clearance requirements of sections 510(k) and 513 of the FD&C Act and of part 807, subpart E, of FDA's regulations (21 CFR part 807).

This final order is effective 30 days after the date of its publication in the Federal Register .

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 administrative order refers to previously approved collections of information found in FDA regulations. The previously approved 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 820 (Quality Management System Regulation) have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 (Investigational Device Exemptions) have been approved under OMB control number 0910-0078; the collections of information in part 807, subpart E (Premarket Notification Procedures), have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 822 (Postmarket Surveillance) have been approved under OMB control number 0910-0449; and the collections of information under 21 CFR part 801 (Device Labeling) have been approved under OMB control number 0910-0485.

Under section 513(f)(3) of the FD&C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. Therefore, under section 513(f)(3) of the FD&C Act, we are codifying in this final order the classification of software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer in the new § 878.1820, under which these devices are reclassified from class III into class II.

The following references are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended) and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

The Department defines “ski area” in regulation because it allows the agency to determine what uses qualify for a ski area permit under the National Forest Ski Area Permit Act of 1986 (16 U.S.C. 497b) and importantly, what uses do not. The National Forest Ski Area Permit Act of 1986 is the sole authority for authorizing Nordic and alpine ski areas on National Forest System lands and the Ski Fee Act of 1996 (16 U.S.C. 497c) requires that qualifying ski areas be charged following the Ski Area Permit Rental Charge formula provided in the Act. The Ski Area Recreation Opportunity Enhancement Act of 2011 further amended 16 U.S.C. 497b, adding more details about other recreational activities that may be authorized under a Ski Area Permit beyond skiing and other snow sports. The 2011 Act provides for authorizing only those other recreational uses as the Secretary deems appropriate, describes the requirements of those recreational activities, and lists specific inclusions and exclusions. At 497b(5), a limitation is put on the authorization of those other recreational uses if they would “result in the primary purpose of the ski area permit to be a purpose other than skiing and other snow-sports.” The ski area definition at 36 CFR 251.51 incorporates the primary purpose concept from the statute to clarify the requirement to limit recreational activities other than skiing and other snow sports in ski areas, and to facilitate agency decision making and compliance with law.

The Department issued an interim final rule on June 28, 2013, revising the definition of a ski area to make it consistent with the authority in section 3 of the Ski Area Recreational Opportunity Enhancement Act of 2011, which allows ski areas to provide other types of natural resource-based recreation as long as the primary purpose of the site remains snow sports (78 FR 38842). The definition of a ski area, as promulgated in the 2013 interim final rule, also includes a revenue test to determine if a ski area's primary purpose is for skiing and snow sports based solely on whether the preponderance of revenue generated by the ski area comes from those activities. This revenue test was carried forward from the previous version of the definition of a ski area. The interim final rule implementing the new definition went into effect on July 29, 2013.

The Department received one comment letter during the public comment period that accompanied the interim final rule. The comment submitted by the National Ski Areas Association argued that the revenue test included in the definition is inappropriate for determining whether the primary purpose of a ski area is snow sports because of its lack of basis in statute. The comment suggested that the Department remove the revenue test to preserve the flexibility for four-season operations that the Ski Area Recreational Opportunity Enhancement Act authorized.

Since the current definition became effective in 2013, the Forest Service has observed that the preponderance of revenue test has not singularly correlated to whether a ski area's primary purpose is skiing and other snow sports. Rather, experience demonstrates that the agency should be considering multiple factors, assessed on a case-by-case basis, to more accurately determine the primary purpose of a ski area. In addition to revenue, these other factors may include skiing vs. non-skiing comparisons of visitation, acreage, facility square footage, length of season, financial investment, or even a general comparison of whether the permitted area looks and feels primarily like a ski area.

The revenue test has also become less useful in the last decade due to significant fluctuations in seasonal snow conditions. Many ski areas, especially those in southern regions, now rely more on revenue from non-skiing activities to stay solvent between years of greater snowfall. This trend further suggests that the Forest Service should consider multiple factors on a site-specific basis to determine the primary purpose of a ski area, rather than relying solely on the preponderance of revenue.

After consideration of the comment received on the interim final rule, the agency's experience in implementing the current definition, and changing conditions on the ground, the Department has determined that the preponderance of revenue test currently found at 36 CFR 251.51 is inappropriate. The revenue test is not found in the authorizing statutes, including the Ski Area Recreational Opportunity Enhancement Act of 2011, the Ski Fee Act of 1996, and the National Forest Ski Area Permit Act of 1986. Removing the revenue test from the definition will align the regulation more closely with statute and provide for additional discretion of authorized officers to determine whether a site and associated facilities qualify as a ski area. Such discretion remains bounded by the statutory requirement in 16 U.S.C. 497b that the primary purpose of a ski area permit be skiing and other snow sports. Therefore, in this final rule, the revenue test is removed.

The Department has determined that additional notice and comment is not required for this final rule. The interim final rule expressly solicited public comment on the revised definition of a ski area, including the preponderance of revenue test. The final rule is a logical outgrowth of the interim final rule and the comment received because it adopts the precise change requested by the commenter and does not introduce new regulatory concepts or requirements beyond the scope of the interim final rule.

The Department also notes that the interim final rule has been in effect since 2013, and this final rule removes an existing regulatory constraint rather than imposing new obligations. Accordingly, the Department has determined that the final rule does not raise additional notice concerns despite the period between issuance of the interim final rule and adoption of this final rule.

The final rule maximizes the discretion of authorized officers to determine whether a site and associated facilities qualify as a ski area based on any number of relevant factors consistent with statutory limitations. It also reduces the regulatory burden on ski area permit holders should an area not meet the revenue test but is otherwise designed and managed primarily for skiing and other snow sports. The final rule allows additional flexibility in how permit holders set up their operations while allowing them to retain the unique benefits afforded by a ski area term permit. The revised definition in the final rule does not eliminate the possibility that a ski area may be found to no longer qualify as a ski area under the “primary purpose” requirement found in 16 U.S.C. 497b. Ski areas that no longer meet this requirement may seek re-authorization under an authority other than 16 U.S.C. 497b for continued use and occupancy of NFS lands.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will determine whether a regulatory action is significant as defined by E.O. 12866 and will review significant regulatory actions. OIRA has determined that this final rule is not significant as defined by E.O. 12866. E.O. 13563 reaffirms the principles of E.O. 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 Department has developed the final rule consistent with E.O. 13563.

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801 et seq. ), OIRA has designated this final rule as not a major rule as defined by 5 U.S.C. 804(2).

The final rule will revise the definition of a ski area by rescinding the revenue test currently found in the definition. Departmental regulations at 7 CFR 1b.4(c)(20) exclude from documentation in an environmental assessment or environmental impact statement “rules, regulations, or policies to establish servicewide administrative procedures, program processes, or instructions.” The Department's assessment is that this final rule falls within this category of actions and that no extraordinary circumstances exist which will require preparation of an environmental assessment or environmental impact statement.

The Department has considered this final rule under the Regulatory Flexibility Act (5 U.S.C. 602 et seq. ). Removing the preponderance of revenue test from the definition of a ski area may benefit large and small ski areas by providing increased flexibility to maintain authorization for skiing and snow sports alongside other authorized year-round uses under a ski area term permit. This final rule will not impose recordkeeping requirements on small entities; will not affect their competitive position in relation to large entities; and will not affect their cash flow, liquidity, or ability to remain in the market. Therefore, the Department has determined that this final rule will not have a significant economic impact on a substantial number of small entities pursuant to the Regulatory Flexibility Act.

The Department has considered this final rule under the requirements of E.O. 13132, Federalism. The Department has determined that the final rule conforms with the federalism principles set out in this E.O.; will not impose any compliance costs on the States; and will not have substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, the Department has concluded that this final rule will not have federalism implications.

E.O. 13175, Consultation and Coordination With Indian Tribal Governments, requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. This final rule revises the definition of a ski area by rescinding the revenue test currently found in the definition. The Department has reviewed this final rule in accordance with the requirements of E.O. 13175 and has determined that this final rule could have substantial direct effects on 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. Therefore, the Department determined that consultation and coordination with Indian Tribal governments is required for this final rule.

Tribal Summary Impact Statement: The Forest Service sent out information about the draft final rule, along with an invitation to consult on July 31, 2025. On September 2, 2025, the Forest Service received a request from the Quapaw Nation for maps associated with the final rule. The final rule applies to all ski areas and future ski areas throughout the National Forest System and does not contain a specific spatial component that could be suitably depicted on a map. Therefore, the Forest Service responded that maps are not available for this final rule. On November 18, 2025, the Forest Service received a letter from the Snoqualmie Tribe expressing frustration with the lack of information provided on the draft final rule and highlighting that Tribal interests could be impacted by the final rule. The Forest Service followed up with the Snoqualmie Tribe to provide any additional information that would be helpful to their understanding and analysis of the final rule. No requests for consultation have been received for this final rule.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277), requires Federal agencies to issue a Family Policymaking Assessment for a rule that may affect family well-being. The final rule will have no impact on the autonomy or integrity of the family as an institution. Accordingly, the Department has concluded that it is not necessary to prepare a Family Policymaking Assessment for the final rule.

The Department has analyzed the final rule in accordance with the principles and criteria in E.O. 12630, Governmental Actions and Interference with Constitutionally Protect Property Rights.

The Department has determined that the final rule will not pose the risk of a taking of private property.

The Department has reviewed the final rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Department has determined that the final rule will not constitute a significant energy action as defined in E.O. 13211.

The Department has analyzed the final rule in accordance with the principles and criteria in E.O. 12988, Civil Justice Reform. Upon publication of the final rule, (1) all State and local laws and regulations that conflict with the final rule or that impede its full implementation will be preempted; (2) no retroactive effect will be given to this final rule; and (3) it will not require administrative proceedings before parties may file suit in court challenging its provisions.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Department has assessed the effects of the final rule on State, local, and Tribal governments and the private sector. The final rule will not compel the expenditure of $100 million or more, adjusted annually for inflation, in any 1 year by State, local, and Tribal governments in the aggregate or by the private sector. Therefore, a statement under section 202 of the Act is not required.

The final rule does not contain any recordkeeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and its implementing regulations at 5 CFR part 1320 do not apply.

Therefore, for the reasons set forth in the preamble, the Department amends chapter II of title 36 of the Code of Federal Regulations as follows:

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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(c)(2)(A)(i) allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” FFDCA section 408(c)(2)(A)(ii) 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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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 . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

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. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. 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 the docket ID number EPA-HQ-OPP-2024-0109 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 May 26, 2026.

EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Order Urging Electronic Filing and Service,” dated December 3, 2025, which can be found at https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf .

Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.

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 at 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. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

In the Federal Register of March 22, 2024 (89 FR 20410) (FRL-11682-02-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11844) filed by Momentive Performance Materials, Inc, 2750 Balltown Road, Niskayuna, NY 12309. The petition requested that 40 CFR 180.960 be amended by changing (lowering) the minimum number average molecular weight for methyl end-capped polydimethylsiloxane to 1200 amu; CAS Reg. No 63148-62-9. That document included a summary of the petition prepared by the petitioner, which is available in the docket. The Agency received 3 public comments. All 3 comments were in support of this inert ingredient approval.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(b)(2)(D), 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 methyl end-capped polydimethylsiloxane including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with methyl end-capped polydimethylsiloxane follows.

In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Methyl end-capped polydimethylsiloxane conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. A provided referenced publication shows that the cyclic monomers and short chain linear siloxanes are not readily biodegradable by OECD 301 test methods.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 Daltons.

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria: specified in 40 CFR 723.250(e):

The polymer's number average MW of 1200 Daltons is greater than 1,000 and less than 10,000 Daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, methyl end-capped polydimethylsiloxane meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to methyl end-capped polydimethylsiloxane.

For the purposes of assessing potential exposure under this exemption, EPA considered that methyl end-capped polydimethylsiloxane could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of methyl end-capped polydimethylsiloxane is 1,200 Daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since methyl end-capped polydimethylsiloxane conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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.”

EPA has not found methyl end-capped polydimethylsiloxane to share a common mechanism of toxicity with any other substances, and methyl end-capped polydimethylsiloxane does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that methyl end-capped polydimethylsiloxane does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of methyl end-capped polydimethylsiloxane, EPA has not used a safety factor analysis to assess the risk. For the same reasons no additional safety factor is needed for assessing risk to infants and children.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of methyl end-capped polydimethylsiloxane.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Accordingly, EPA finds that exempting residues of methyl end-capped polydimethylsiloxane from the requirement of a tolerance will be safe.

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

This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408.

Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because actions that establish a tolerance under FFDCA section 408 are exempted from review under Executive Order 12866.

This action does not impose an information collection burden under the PRA 44 U.S.C. 3501 et seq., because it does not contain any information collection activities.

This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to the APA but is subject to FFDCA section 408(d), which does not require notice and comment rulemaking to take this action in response to a petition.

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

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

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

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866 (See Unit V.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's 2021 Policy on Children's Health applies to this action.

This rule finalizes tolerance actions under the FFDCA, which 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 . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in the pesticide-specific registration review documents, located in the applicable docket at https://www.regulations.gov.

This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

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

For the reasons stated in the preamble, 40 CFR chapter I is amended as follows:

The IPHC has recommended regulations that would govern the Pacific halibut fishery in 2026, pursuant to the Convention between Canada and the United States for the Preservation of the Halibut Fishery of the North Pacific Ocean and Bering Sea (Convention), signed at Ottawa, Ontario, on March 2, 1953, as amended by a Protocol Amending the Convention (signed at Washington, DC, on March 29, 1979).

As provided by the Northern Pacific Halibut Act of 1982 (Halibut Act), the Secretary of State, with the concurrence of the Secretary of Commerce, may accept or reject, on behalf of the United States, regulations recommended by the IPHC in accordance with the Convention. 16 U.S.C. 773b. The Secretary of State, with the concurrence of the Secretary of Commerce, accepted the 2026 IPHC Fishery Regulations on March 12, 2026, thereby making them effective.

The Halibut Act provides the Secretary of Commerce with the authority and general responsibility to carry out the requirements of the Convention and the Halibut Act. The PFMC and NPFMC may develop, and the Secretary of Commerce may implement, regulations governing harvesting privileges among U.S. fishermen in U.S. waters that are in addition to, and not in conflict with, approved IPHC regulations. The NPFMC has exercised this authority in developing halibut management programs for three fisheries that harvest halibut off Alaska: the subsistence, sport, and commercial fisheries. The PFMC has exercised this authority by developing a catch sharing plan governing the allocation of halibut and management of sport (recreational) and commercial halibut fisheries on the U.S. West Coast.

The IPHC apportions catch limits for the Pacific halibut fishery among regulatory areas (Figure 1): Area 2A (California, Oregon, and Washington), Area 2B (British Columbia), Area 2C (Southeast Alaska), Area 3A (Central Gulf of Alaska), Area 3B (Western Gulf of Alaska), and Area 4 (which is further divided into 5 areas, 4A through 4E, in the Bering Sea and Aleutian Islands of Western Alaska).

Subsistence and sport halibut fishery regulations for Alaska, as well as tribal (commercial, and ceremonial and subsistence), and non-Tribal commercial (directed and incidental) and recreational (sport) fishery regulations for Area 2A, are codified at 50 CFR part 300. Commercial halibut fisheries off Alaska are subject to regulations resulting from the Individual Fishing Quota (IFQ) Program, the Community Development Quota (CDQ) Program (50 CFR part 679), and the area-specific catch sharing plans for Areas 2C, 3A, and Areas 4C, 4D, and 4E, respectively.

The NPFMC implemented a catch sharing plan among commercial IFQ and CDQ halibut fisheries in IPHC Regulatory Areas 4C, 4D, and 4E (commonly referred to as Area 4CDE, Bering Sea) through rulemaking, and the Secretary of Commerce approved the plan on March 20, 1996 (61 FR 11337). The Area 4 catch sharing plan regulations are codified at 50 CFR 300.65. New annual regulations pertaining to the Area 4 catch sharing plan also may be implemented through IPHC action, subject to acceptance by the Secretary of State, with the concurrence of the Secretary of Commerce.

The NPFMC recommended and NMFS implemented through rulemaking a catch sharing plan for commercial IFQ and guided sport (charter) halibut fisheries in IPHC Regulatory Areas 2C and 3A on January 13, 2014 (78 FR 75844, December 12, 2013). The Area 2C and 3A catch sharing plan regulations are codified at 50 CFR 300.65. The catch sharing plan defines an annual process for allocating halibut between the commercial and charter fisheries so that each sector's allocation varies in proportion to halibut abundance, specifies a public process for setting annual management measures, and authorizes limited annual leases of commercial IFQ for use in the charter fishery as guided angler fish (GAF).

The IPHC held its annual meeting in Bellevue, Washington, from January 19 through 22, 2026, and recommended a number of changes to the previous IPHC regulations (90 FR 13293, March 21, 2025). On March 12, 2026, the Secretary of State, with the concurrence of the Secretary of Commerce, accepted the annual management measures, including the following changes to section 5, section 9, section 11, section 26, and section 28 of the 2026 IPHC Fishery Regulations:

1. New halibut catch limits in IPHC Regulatory Areas. The catch limits are presented in two tables in section 5. They distinguish between limits resulting from Commission decisions and limits that result from domestic catch sharing plans that have been developed by the respective United States and Canada Governments;

2. New commercial fishery season dates and start time in section 9;

3. New regulations allowing, for one year, limited retention of legal-sized Pacific halibut caught incidentally as bycatch outside the Pacific halibut commercial fishing period in year-round hook and line and trap groundfish fisheries in Area 2B in section 11;

4. New recreational fishery season dates and management measures for Area 2A in section 26; and

5. New management measures for Area 2C and Area 3A guided sport fisheries in section 28.

Pursuant to regulations at 50 CFR 300.62, the 2026 annual management measures are published in the Federal Register in this action to provide notice of their regulatory effectiveness and to inform persons subject to the regulations of their restrictions and requirements. Because NMFS publishes the IPHC's annual management measures in this action, and those measures are applicable to the entire Convention area, this action includes some provisions relating to Canadian fishing and fisheries. In separate actions, NMFS may implement more restrictive regulations for the U.S. halibut fishery or components of it; therefore, anglers are advised to check the current Federal and IPHC regulations prior to fishing.

The IPHC recommended to the governments of Canada and the United States a 2026 coastwide mortality limit, also called the Total Constant Exploitation Yield (TCEY), of 29,330,000 pounds (lb) (13,304 metric tons (mt)). Coastwide, the 2026 TCEY decreased 1.3 percent relative to 2025. The 2026 TCEY remained the same as the one from 2025 in all IPHC Regulatory Areas except Area 2B where it decreased. The IPHC refers to catch limits as Fishery Constant Exploitation Yield (FCEY), which are derived from the TCEY by directed fisheries that are specified in the IPHC regulations and are subject to area-specific catch agreements among the domestic parties. A description of the process the IPHC used to set these TCEY mortality limits and a more detailed description of FCEY catch limits follows.

For the upcoming 2026 halibut fishing year, the IPHC conducted its annual stock assessment using a range of updated data sources as described in detail in the IPHC overview of data sources for the Pacific halibut stock assessment, harvest policy, and related analyses (IPHC-2026-AM102-R-Report-of-the-AM102; available at https://www.iphc.int ). To evaluate the Pacific halibut stock, the IPHC uses an “ensemble” of four equally weighted models: two long time-series models incorporating data from 1888 to the present and two short time-series models incorporating data from 1992 to the present. For each time-series, the two models include data that are either divided by four geographical regions or aggregated into coastwide summaries. These models incorporate data through 2025 from the IPHC Fishery Independent Setline Survey (FISS); the commercial halibut fishery; the NMFS Eastern Bering Sea trawl survey; length and weight-at-age and male/female sex ratio estimates by region in the directed commercial fisheries and in the FISS; and age distribution information for bycatch, sport, and sublegal discard removals.

The results of the ensemble models are integrated and incorporate uncertainty in natural mortality rates, environmental effects on recruitment, and other structural and parameter categories, consistent with practices in place since 2012. The data and assessment models used by the IPHC are reviewed by the IPHC's Scientific Review Board, comprised of non-IPHC scientists who provide an independent scientific review of the data and stock assessment to provide recommendations to IPHC staff and the Commissioners. The Scientific Review Board did not identify any substantive errors in the data or methods used in the 2025 stock assessment. NMFS believes the IPHC's data and assessments models constitute the best available science on the status of the Pacific halibut resource.

The IPHC's data, including the FISS, indicate that the Pacific halibut stock declined continuously from the late 1990s to around 2012, largely as a result of decreasing size at a given age (size-at-age), higher harvest rates in the early 2000s, and weaker recruitment than observed during the 1980s. In more recent years, from 2016 to 2024, the spawning biomass is estimated to have declined 34 percent, then increased by 8 percent, to 166,000,000 lb (73,300 mt) at the beginning of 2026, largely as a function of the 2012 and maturing 2016 and 2017 year classes. The spawning biomass is currently estimated to be at 38 percent of its unfished state, and is near the lowest level observed since the 1970s. This estimate reflects updated calculations recommended during stock assessment external review and review by the Scientific Review Board, as well as developments in the IPHC Management Strategy Evaluation.

The IPHC accounts for the total mortality of halibut from all sources and employs a management procedure that establishes a coastwide reference level of fishing intensity so that the Spawning Potential Ratio (SPR) is equal to 43 percent. Fishing intensity is expressed as an F value; therefore, the reference fishing intensity of 43 percent SPR ( i.e., F43) would allow a level of fishing intensity that is expected to result in approximately 43 percent of the spawning biomass per recruit compared to an unfished stock ( i.e., no fishing mortality). Lower F percentages would be expected to result in higher fishing intensity.

The IPHC harvest decision table (table 2 in IPHC-2026-AM102-R-Report-of-the-AM102; available at https://www.iphc.int ) provides a comparison of the relative risk of a decrease in stock biomass, stock status, or fishery metrics for a range of fishing intensities for 2026. The harvest decision table employs two metrics of fishing mortality: (1) the TCEY, which includes harvests and incidental discard mortality from directed commercial fisheries; mortality estimates from sport, subsistence, and personal use; and estimates of non-directed discard mortality of halibut over 26 inches (66.0 centimeters (cm)) (O26); and (2) Total Mortality, which includes all the above sources of mortality, plus estimates of non-directed discard mortality of halibut less than 26 inches (66.0 cm) (U26). Although U26 halibut mortality is factored into the stock assessment and harvest strategy calculations, there is currently no reliable tool for estimating the annual coastwide distribution of U26 halibut.

For 2026, the IPHC recommended a TCEY totaling 29,330,000 lb (13,304 mt) coastwide. This corresponds to a fishing intensity of approximately F51 percent, which is similar to 2025 (F52 percent) and more conservative than the F43 percent reference level of fishing intensity used to establish TCEYs in years prior to 2023. The 2026 TCEY is 390,000 lb (177 mt), or 1.3 percent, less than the TCEY adopted in 2025.

In making its recommendation, the IPHC considered likely stock status and uncertainties, as well as the significant social and economic impacts of catch limits among areas. The IPHC noted that that while spawning biomass increased by 7 percent to the beginning of 2026, the stock remains heavily reliant on specific year-classes (2012, 2016, and 2017). Additionally, both the FISS and fishery performance indices remain at or near historically low levels. However, the IPHC determined that additional small reductions were unlikely to make a meaningful change in the stock trajectory following the already substantial reductions in TCEY in 2023 (10.3 percent), 2024 (4.6 percent), and 2025 (15.8 percent).

At a coastwide TCEY of 29,330,000 lb (13,304 mt), the IPHC considered the probability that the spawning biomass will decrease through 2029. The IPHC estimated a 14 percent probability of stock decline through 2027, and a 17 percent probability of stock decline through 2029. The IPHC noted that if the recent reference level of fishing intensity was adopted ( i.e., F43), the probability of a spawning biomass decline was 15 percent by 2027 and 18 percent by 2029. The factors that the IPHC considered in making their TCEY recommendations are described in the 2026 Annual Meeting Report (IPHC-2026-AM102-R-Report-of-the-AM102; available at https://www.iphc.int ), and the key recommendations are briefly summarized here.

This final rule does not establish the combined commercial and recreational catch limit for Area 2B (British Columbia), which is subject to rulemaking by Canada and British Columbia. However, the IPHC's recommendation for the Area 2B catch limit is directly related to the current and future U.S. catch limits established by this final rule and is therefore discussed herein. The IPHC recommended a 2026 TCEY of 5,060,000 lb (2,295 mt) for Area 2B, which equates to 17.3 percent of the total coastwide TCEY and is a 7.2 percent reduction from 2025. The IPHC made this recommendation after considering recent harvests in Area 2B, and similar factors associated with the stock conditions, commercial fishery and FISS performance, and stock assessment results described above in the 2026 Annual Meeting Report (IPHC-2026-AM102-R-Report-of-the-AM102; available at https://www.iphc.int ). Of primary importance to this decision were decreases in the distribution of the commercially harvestable portion of the stock in Area 2B.

The IPHC adopted an allocation for Area 2A that would provide a TCEY of 1,650,000 lb (748 mt). Although the 2026 TCEY in Area 2A remained the same as 2025, the combined Tribal (commercial, and ceremonial and subsistence), and non-Tribal commercial (directed and incidental) and recreational (sport) fishery limits, i.e., FCEYs, increased by less than 1 percent to 1,540,000 lb (699 mt). This was a result of reduced estimates of commercial directed and non-directed fishery discards in Area 2A for 2026.

For Area 2A, the IPHC noted that a status quo TCEY does not pose a conservation concern for 2026. Additionally, the U.S. Government recognizes its trust responsibility to the 13 treaty tribes in IPHC Regulatory Area 2A that depend upon Pacific halibut. As such, the U.S. Commissioners have supported a TCEY of 1,650,000 lb (748 mt) for Regulatory Area 2A since 2019. This allocation reflects the needs of West Coast Pacific halibut users, with minimal impact on the larger Pacific halibut biomass that is distributed to the north, and it remains a small fraction of the IPHC Biological Region 2 allocation.

The IPHC recommended the same TCEY for 2026, relative to 2025, for all Alaska areas (see table 1). The IPHC determined that these 2026 catch limit recommendations are consistent with its conservation objectives for the halibut stock and its management objectives for the halibut fisheries. The IPHC also considered the distribution of harvestable biomass of halibut based on the FISS, 2025 harvest rates, the recommendations from the IPHC's advisory bodies, public input, social and economic factors, and the catch sharing plan for Area 4CDE developed by the NPFMC in its TCEY recommendation.

The Area 4CDE catch limit is determined by subtracting estimates of the Area 4CDE subsistence harvests, commercial discard mortality, and non-directed discard mortality of halibut over 26 inches (66.0 cm) from the area TCEY. When the resulting Area 4CDE catch limit is greater than 1,657,600 lb (752 mt), a direct allocation of 80,000 lb (36 mt) is made to Area 4E to provide CDQ fishermen in that area with additional harvesting opportunity. After this 80,000 lb (36.29 mt) allocation is deducted from the catch limit, the remainder is divided among Area 4CDE according to the percentages specified in the catch sharing plan. Those percentages are 46.43 percent each to 4C and 4D and 7.14 percent to 4E. For 2026, after the adjustments for non-directed halibut discards were made, the IPHC recommended a TCEY for Area 4CDE of 3,080,000 lb (1,397 mt). The 2026 FCEY for Area 4CDE was 1,630,000 lb (739 mt), which is below the 1,657,600 lb (752 mt) threshold for the direct allocation of 80,000 lb (36 mt) to Area 4E.

The IPHC considers advice from the IPHC's two advisory bodies (the Conference Board and the Processor Advisory Board), as well as testimony from the public, when selecting opening and closing dates and times for the commercial halibut fishery. The 2026 commercial halibut fishery opening date for all IPHC regulatory areas is March 26, 2026. The closing date for the commercial halibut fisheries in all IPHC regulatory areas is December 7, 2026. The March 26 commercial season opening date accounts for favorable tide conditions and is 6 days later than the March 20 opening in 2025, while the closing date of December 7 is consistent with the closing dates from 2021 through 2025, representing an extension of time beyond the mid-November closing common in the years prior to 2021. The extended season maintains harvesting and market flexibility that stakeholders have identified as important during the current period of uncertainty. The season dates allow for the anticipated time required to fully harvest the commercial halibut catch limits as well as adequate time for IPHC staff to review the complete record of 2026 commercial catch data for use in the stock assessment process. The IPHC also considered the time required for the administrative tasks that are linked to halibut regulations developed independently by domestic parties when establishing these season dates.

The IPHC retained the time of day for opening the 2026 fishery at 06:00 local time, which is the same as the 2025 fishery. Opening the fishery at 06:00 was in response to recommendations from the IPHC's two advisory bodies, which noted that allowing a full day of fishing on March 26 facilitates access to markets and improves fishing efficiency and opportunity.

For the Area 2A non-Tribal directed commercial fishery, NMFS West Coast Region will conduct a separate rulemaking to implement certain annual management measures that are not implemented through the IPHC. Management measures will include vessel catch limits, as well as fishing periods that fall within the coastwide commercial season dates set forth in section 9 of the IPHC regulations. Public comments regarding the proposed rule will be accepted and NMFS will address any comments received in a final rule.

For the Area 2A recreational (sport) fishery, the NMFS West Coast Region will conduct a separate rulemaking to approve changes to the Pacific halibut catch sharing plan and implement annual management measures, as recommended by the PFMC in the catch sharing plan. These annual management measures include recreational (sport) fishery subarea allocations and management measures that are not implemented through the IPHC. Such IPHC management measures are described below in the International Pacific Halibut Commission Fishery Regulations 2026 (Annual Management Measures) section, which contains new language at section 26 specifying the opening dates and season structures for the Washington Puget Sound and U.S. Convention waters in the Strait of Juan de Fuca, as well as the California subareas. This new language is intended to ensure that these early season recreational (sport) fisheries are able to open on time. NMFS will address any comments received in a separate final rule for the Area 2A recreational (sport) fishery.

Once published, the proposed and final rules for Area 2A will be available on the NMFS West Coast Region's website at https://www.fisheries.noaa.gov/west-coast/commercial-fishing/pacific-halibut-fishing-west-coast and also at https://www.regulations.gov.

For 2026, the IPHC adopted regulations for opening dates for Area 2A, consisting of the recreational (sport) fishery in Puget Sound and the Strait of Juan de Fuca subarea (April 2) and the waters off California subareas on April 1, in section 26 of the IPHC regulations.

In 2014, NMFS implemented a catch sharing plan for Area 2C and Area 3A. The catch sharing plan defines an annual process for allocating halibut between the charter and commercial fisheries in Area 2C and Area 3A and establishes allocations for each fishery. Under the catch sharing plan, the IPHC adopted combined catch limits (CCL) for the commercial and charter halibut fisheries in Area 2C and Area 3A. Each CCL includes estimates of discard mortality for each fishery. The catch sharing plan was implemented to achieve the halibut fishery management goals of the NPFMC. More information is provided in the final rule implementing the catch sharing plan (78 FR 75844, December 12, 2013). Implementing regulations for the catch sharing plan are at 50 CFR 300.65. The Area 2C and Area 3A catch sharing plan allocations are located in tables 1 through 4 of subpart E of 50 CFR part 300. To allow additional flexibility for individual commercial and charter fishery participants, the catch sharing plan also authorizes annual transfers of commercial halibut IFQ as GAF to charter halibut permit holders for harvest in the charter fishery. Pacific halibut that are retained by charter vessel anglers as GAF are not subject to the annual charter halibut management measures specified in the 2026 IPHC Fishery Regulations. Under the catch sharing plan regulations, charter vessel anglers may use GAF to harvest up to two halibut of any size per day. Complete GAF regulations for the catch sharing plan are at 50 CFR 300.65.

At its January 2026 meeting, the IPHC adopted an Area 2C TCEY of 5,220,000 lb (2,368 mt) which resulted in a CCL of 3,560,000 lb (1,615 mt) for Area 2C. Following the catch sharing plan allocations in tables 1 and 3 of subpart E of 50 CFR part 300, the charter fishery is allocated 650,000 lb (295 mt) of the CCL, and the remainder of the CCL, 2,910,000 lb (1,320 mt), is allocated to the commercial fishery. Discard mortality in the amount of 100,000 lb (45 mt) was deducted from the commercial allocation to obtain the commercial catch limit of 2,810,000 lb (1,275 mt). The commercial allocation (including discard mortality) decreased by 260,000 lb (118 mt), or 8.5 percent, from the 2025 allocation of 3,070,000 lb (1,393 mt). The 2026 Area 2C charter allocation of 650,000 lb (295 mt) is 70,000 lb (32 mt), or 9.7 percent less than the 2025 charter allocation of 720,000 lb (327 mt).

The IPHC adopted an Area 3A TCEY of 9,080,000 lb (4,119 mt) resulting in a CCL of 7,800,000 lb (3,538 mt) for Area 3A. Following the catch sharing plan allocations in tables 2 and 4 of subpart E of 50 CFR part 300, the charter fishery is allocated 1,470,000 lb (667 mt) of the CCL and the remainder of the CCL, 6,320,000 lb (2,871 mt), is allocated to the commercial fishery. Discard mortality in the amount of 360,000 lb (163 mt) was deducted from the commercial allocation to obtain the commercial catch limit of 5,960,000 lb (2,672 mt). The commercial allocation (including discard mortality) decreased by 80,000 lb (36 mt), or 1.4 percent, from the 2025 allocation of 5,890,000 lb (2,672 mt). The 2026 Area 3A charter allocation dropped 10,000 lb (5 mt), or 0.7 percent, from 2025.

Guided sport (charter) halibut anglers are managed under different regulations than unguided recreational halibut anglers in Areas 2C and 3A in Alaska. According to Federal regulations at 50 CFR 300.61, a charter vessel angler means a person, paying or non-paying, receiving sport fishing guide services for halibut. Sport fishing guide services means assistance, for compensation or with the intent to receive compensation, to a person who is sport fishing, to take or attempt to take halibut by accompanying or physically directing the sport fisherman in sport fishing activities during any part of a charter vessel fishing trip. A charter vessel fishing trip is the time period between the first deployment of fishing gear into the water from a charter vessel by a charter vessel angler and the offloading of one or more charter vessel anglers or any halibut from that vessel. The charter halibut management measures included in the 2026 IPHC Fishery Regulations described below apply only to charter vessel anglers receiving sport fishing guide services during a charter vessel fishing trip for halibut in Area 2C or Area 3A. These regulations do not apply to unguided recreational anglers in any regulatory area in Alaska, nor to charter vessel anglers in areas other than Areas 2C and 3A.

By way of background, to provide recommendations for annual management measures intended to limit charter harvest to the charter catch allocation, the NPFMC formed the Charter Halibut Management Committee (Committee) as a stakeholder advisory body. The Committee is composed of representatives from the charter fishing industry in Areas 2C and 3A who provide input on the preferred range of charter management measures each year. In October 2025, the Committee began their annual process by requesting analysis of management measures that would result in charter halibut removals within the range of expected allocations for each area. In addition, this annual analysis, which is prepared by the Alaska Department of Fish and Game (ADFG), includes information about charter harvests in the prior year. The Analysis of Management Options for the Area 2C and 3A Charter Halibut Fisheries for 2026 (charter halibut analysis) is available at https://www.npfmc.org/.

After reviewing the charter halibut analysis, the Committee made conservative recommendations for preferred management measures to the NPFMC for 2026. These recommendations were intended to provide equitable harvest opportunity across charter business arrangements and maintain total charter harvests within the 2026 allocations for both Areas 2C and 3A. The NPFMC considered the charter halibut analysis, the recommendations of the Committee, and public testimony to develop its recommendation to the IPHC. The NPFMC has used this process to select and recommend annual charter halibut management measures to the IPHC since 2012.

The IPHC recognizes the role of the NPFMC to develop policy and regulations that allocate the Pacific halibut resource among fishermen in and off Alaska and that NMFS has developed numerous regulations to support the NPFMC's goals of limiting the charter halibut harvest to the charter catch allocation. The IPHC's adopted recommendations are consistent with the recommendations of the NPFMC and the Committee. The IPHC determined that limiting charter harvests by implementing the management measures discussed below would meet conservation and allocation objectives.

For 2026 in Area 2C, the IPHC adopted the continuation of a one-fish daily bag limit that has been in effect each year for charter vessel anglers since the catch sharing plan was implemented in 2014. This bag limit is combined with a size limit on retained Pacific halibut, and day of the week closures. Area 2C regulations for 2026 do not include provisions that charter halibut permits and charter vessels may only be used for one charter vessel fishing trip per day when one or more anglers on board catch and retain halibut, as were in place for 2025.

The size limit prohibits any person on board a charter vessel from taking or possessing any halibut, with head on that is greater than 34 inches (86.4 cm) and less than 80 inches (203.2 cm). All charter halibut size limits referenced in this document are measured in a straight line from the tip of the lower jaw with mouth closed, passing over the pectoral fin, to the extreme end of the middle of the tail. The day of the week closures prohibit the retention of Pacific halibut by charter vessel anglers on Thursdays from June 18 through September 10, 2026.

These management measures are more restrictive than the similar size and day of the week closure measures implemented in 2025. To develop these measures, the Committee, the NPFMC, and IPHC considered the ADFG analysis that evaluated the performance of prior years' measures, as well as projections of charter halibut fishing effort for 2026. With the above management measures in place, the projected charter harvest is expected to meet the 650,000 lb (295 mt) charter halibut allocation for Area 2C. The more conservative management measures relative to 2025 are a result of a static TCEY in Area 2C and larger dedications from non-FCEY mortality estimates primarily driven by greater unguided recreational halibut harvests.

For 2026, the IPHC adopted the following management measures for Area 3A: (1) a two-fish daily bag limit that allows one fish of any size and a 27 inch (68.6 cm) maximum size limit for the other halibut; (2) a prohibition on halibut retention by charter vessel anglers on all Tuesdays and Wednesdays from June 2 through August 25, 2026; and (3) a one-trip per day limit for charter halibut permits and charter vessels for the entire season. Regarding the day closures, such closures in Area 3A have proven effective in decreasing the charter halibut harvest to help stay within the allocation. The charter vessel and charter halibut permit trip limits are discussed further below.

The Area 3A management measures for 2026 are similar to those imposed in 2025, but allow for harvest on some Wednesdays. The NPFMC and IPHC also considered information on charter removals in 2025 and for previous years, as well as the projections of charter harvest in 2026 to determine the management measures in Area 3A. With the above management measures in place, the projected charter harvest is expected to meet the 1,470,000 lb (667 mt) charter halibut allocation for Area 3A.

As noted above, in Area 3A, charter halibut permits and charter vessels in 2026 are authorized for use to catch and retain halibut on one charter halibut fishing trip per day. These regulations have been in place each year since 2016 in Area 3A, and have proven effective in controlling halibut harvests. While a similar regulation was adopted for Area 2C in 2025, this was not recommended or included for Area 2C in 2026 given disproportionate impacts to certain charter business operation types.

Consistent with 2025, the 2026 IPHC Fishery Regulations contain a definition of charter vessel fishing trip that differs from the definition of that term at 50 CFR 300.61. Namely, for purposes of the trip limits in Area 3A during 2026, a charter vessel fishing trip begins the first time Pacific halibut are caught and retained. If no halibut are retained during a charter vessel fishing trip, the charter halibut permit and charter vessel may be used to take an additional trip to catch and retain halibut that day. A charter vessel fishing trip will end at the end of the calendar day, when any angler is offloaded, or when any halibut is offloaded, whichever comes first. A charter halibut permit or charter vessel may conduct overnight trips since charter vessel anglers may retain a bag limit of halibut on two calendar days. But a charter halibut permit or charter vessel cannot be used to begin another overnight trip until the day after the previous charter vessel fishing trip ends.

Also, GAF are exempt from the management measures for charter vessel fishing, including trip limits. Therefore, a charter halibut permit and a charter vessel may be used to harvest GAF on a second charter vessel fishing trip in a day, but only if GAF are exclusively harvested on that trip. Additionally, retention of GAF halibut is allowed on charter vessels on days that are otherwise closed to halibut retention; as noted above, in 2026, in Area 2C, these closed days include all Thursdays from June 18 through September 10, and, in Area 3A, all Tuesdays and Wednesdays from June 2 through August 25.

The following annual management measures for the 2026 Pacific halibut fishery are those recommended by the IPHC and accepted by the Secretary of State, with the concurrence of the Secretary of Commerce.

These Regulations may be cited as the International Pacific Halibut Commission (IPHC) Fishery Regulations (2026).

(1) These Regulations apply to persons and vessels fishing for Pacific halibut in, or possessing Pacific halibut taken from, the maritime area as defined in Section 3.

(2) Sections 3 to 8 and 29 apply generally to all Pacific halibut fishing.

(3) Sections 9 to 22 apply to commercial fishing for Pacific halibut.

(4) Section 23 applies to Indigenous fisheries in British Columbia.

(5) Section 24 applies to customary and traditional fishing in Alaska.

(6) Sections 25 to 28 apply to recreational (also called sport) fishing for Pacific halibut.

(7) These Regulations do not apply to fishing operations authorized or conducted by the Commission for research purposes.

(1) In these Regulations,

(a) “authorized officer” means any State, Federal, or Provincial officer authorized to enforce these Regulations including, but not limited to, the National Marine Fisheries Service (NOAA Fisheries), Department of Fisheries and Oceans (DFO), Alaska Wildlife Troopers (AWT), United States Coast Guard (USCG), Washington Department of Fish and Wildlife (WDFW), the Oregon State Police (OSP), and California Department of Fish and Wildlife (CDFW);

(b) “authorized clearance personnel” means an authorized officer of the United States of America, an authorized representative of the Commission, or a designated fish processor;

(c) “authorized representative of the Commission” means any IPHC employee or contractor authorized to perform any task described in these Regulations.

(d) “charter vessel” outside of Alaska waters means a vessel used for hire in recreational (sport) fishing for Pacific halibut, but not including a vessel without a hired operator, and in Alaska waters means a vessel used while providing or receiving recreational (sport) fishing guide services for Pacific halibut;

(e) “commercial fishing” means fishing, the resulting catch of which is sold or bartered; or is intended to be sold or bartered, other than (i) recreational (sport) fishing; (ii) treaty Indian ceremonial and subsistence fishing as referred to in Section 23; (iii) Indigenous groups fishing in British Columbia as referred to in Section 24; and (iv) customary and traditional fishing as referred to in Section 25 and defined by and regulated pursuant to NOAA Fisheries regulations published at 50 CFR part 300;

(f) “Commission” or “IPHC” means the International Pacific Halibut Commission;

(g) “daily bag limit” means the maximum number of Pacific halibut a person may take in any calendar day from Convention waters;

(h) “fishing” means the taking, harvesting, or catching of fish, or any activity that can reasonably be expected to result in the taking, harvesting, or catching of fish, including specifically the deployment of any amount or component part of gear anywhere in the maritime area;

(i) “fishing period limit” means the maximum amount of Pacific halibut that may be retained and landed by a vessel during one fishing period;

(j) “land” or “offload” with respect to Pacific halibut, means the removal of Pacific halibut from the catching vessel;

(k) “permit” means a Pacific halibut fishing license issued by NOAA Fisheries;

(l) “maritime area,” in respect of the fisheries jurisdiction of a Contracting Party, includes without distinction areas within and seaward of the territorial sea and internal waters of that Party;

(m) “net weight” of a Pacific halibut means the weight of Pacific halibut that is without gills and entrails, head-off, washed, and without ice and slime. If a Pacific halibut is weighed with the head on or with ice and slime, the required conversion factors for calculating net weight are a 2 percent deduction for ice and slime and a 10 percent deduction for the head;

(n) “operator,” with respect to any vessel, means the owner and/or the master or other individual on board and in charge of that vessel;

(o) “overall length” of a vessel means the horizontal distance, rounded to the nearest foot, between the foremost part of the stem and the aftermost part of the stern (excluding bowsprits, rudders, outboard motor brackets, and similar fittings or attachments);

(p) “person” includes an individual, corporation, firm, or association;

(q) “regulatory area” means an IPHC Regulatory Area referred to in Section 4;

(r) “setline gear” means one or more stationary, buoyed, and anchored lines with hooks attached;

(s) “sport fishing” or “recreational fishing” means all fishing other than (i) commercial fishing; (ii) treaty Indian ceremonial and subsistence fishing as referred to in Section 23; (iii) Indigenous groups fishing in British Columbia as referred to in Section 24; and (iv) customary and traditional fishing as referred to in Section 25 and defined in and regulated pursuant to NOAA Fisheries regulations published in 50 CFR part 300;

(t) “tender” means any vessel that buys or obtains fish directly from a catching vessel and transports it to a port of landing or fish processor;

(u) “total constant exploitation yield (TCEY)” means the mortality comprised of Pacific halibut from directed fisheries and that from non-directed fisheries greater than 26 inches (66 cm) in length;

(v) “VMS transmitter” means a NOAA Fisheries-approved vessel monitoring system transmitter that automatically determines a vessel's position and transmits it to a NOAA Fisheries-approved communications service provider. 1

(2) In these Regulations, all bearings are true and all positions are determined by the most recent charts issued by the United States National Ocean Service or the Canadian Hydrographic Service.

The following areas within the IPHC Convention waters shall be defined as IPHC Regulatory Areas for the purposes of the Convention (see Figure 1):

(1) IPHC Regulatory Area 2A includes all waters off the states of California, Oregon, and Washington;

(2) IPHC Regulatory Area 2B includes all waters off British Columbia;

(3) IPHC Regulatory Area 2C includes all waters off Alaska that are east of a line running 340° true from Cape Spencer Light (58°11′56″ N latitude, 136°38′26″ W longitude) and south and east of a line running 205° true from said light;

(4) IPHC Regulatory Area 3A includes all waters between Area 2C and a line extending from the most northerly point on Cape Aklek (57°41′15″ N latitude, 155°35′00″ W longitude) to Cape Ikolik (57°17′17″ N latitude, 154°47′18″ W longitude), then along the Kodiak Island coastline to Cape Trinity (56°44′50″ N latitude, 154°08′44″ W longitude), then 140° true;

(5) IPHC Regulatory Area 3B includes all waters between Area 3A and a line extending 150° true from Cape Lutke (54°29′00″ N latitude, 164°20′00″ W longitude) and south of 54°49′00″ N latitude in Isanotski Strait;

(6) IPHC Regulatory Area 4A includes all waters in the Gulf of Alaska west of Area 3B and in the Bering Sea west of the closed area defined in Section 10 that are east of 172°00′00″ W longitude and south of 56°20′00″ N latitude;

(7) IPHC Regulatory Area 4B includes all waters in the Bering Sea and the Gulf of Alaska west of IPHC Regulatory Area 4A and south of 56°20′00″ N latitude;

(8) IPHC Regulatory Area 4C includes all waters in the Bering Sea north of IPHC Regulatory Area 4A and north of the closed area defined in Section 10 which are east of 171°00′00″ W longitude, south of 58°00′00″ N latitude, and west of 168°00′00″ W longitude;

(9) IPHC Regulatory Area 4D includes all waters in the Bering Sea north of IPHC Regulatory Areas 4A and 4B, north and west of IPHC Regulatory Area 4C, and west of 168°00′00″ W longitude; and

(10) IPHC Regulatory Area 4E includes all waters in the Bering Sea north and east of the closed area defined in Section 10, east of 168°00′00″ W longitude, and south of 65°34′00″ N latitude.

(1) The Commission has adopted the following distributed mortality (TCEY) limits:

(2) The fishery limits resulting from the IPHC-adopted distributed mortality (TCEY) limits and the existing Contracting Party catch sharing arrangements are as follows, recognizing that each Contracting Party may implement more restrictive limits: **

(1) The Commission is authorized to establish or modify regulations during the season after determining that such action:

(a) will not result in exceeding the fishery limit established preseason for each IPHC Regulatory Area;

(b) is consistent with the Convention between Canada and the United States of America for the Preservation of the Halibut Fishery of the Northern Pacific Ocean and Bering Sea, and applicable domestic law of either Canada or the United States of America; and

(c) is consistent, to the maximum extent practicable, with any domestic catch sharing plans or other domestic allocation programs developed by the governments of Canada or the United States of America.

(2) In-season actions may include, but are not limited to, establishment or modification of the following:

(a) closed areas;

(b) fishing periods;

(c) fishing period limits;

(d) gear restrictions;

(e) recreational (sport) bag limits;

(f) size limits; or

(g) vessel clearances.

(3) In-season changes will be effective at the time and date specified by the Commission.

(4) The Commission will announce in-season actions under this Section by providing notice to major Pacific halibut processors; Federal, State, United States of America treaty Indian, and Provincial fishery officials; and the media.

(5) Notwithstanding paragraphs (3) and (4) of this Section, in IPHC Regulatory Area 2A the USA (NOAA Fisheries) may take in-season action to reallocate the recreational fishery limits between Washington, Oregon, and California after determining that such action will not result in exceeding the overall IPHC Regulatory Area 2A recreational fishery limit and that such action is consistent with any domestic catch sharing plan. Any such reallocation will be announced by the USA (NOAA Fisheries) and published in the Federal Register .

(1) All Pacific halibut that are caught and are not retained shall be immediately released outboard of the roller and returned to the sea with a minimum of injury by:

(a) hook straightening;

(b) cutting the gangion near the hook; or

(c) carefully removing the hook by twisting it from the Pacific halibut with a gaff.

(2) Except that paragraph (1) shall not prohibit the possession of Pacific halibut on board a vessel that has been brought aboard to be measured to determine if the applicable size limit of the Pacific halibut is met and, if not legal-sized, is promptly returned to the sea with a minimum of injury.

(1) Nothing contained in these Regulations prohibits any vessel at any time from retaining and landing a Pacific halibut that bears a Commission external tag at the time of capture, if the Pacific halibut with the tag still attached is reported at the time of landing and made available for examination by an authorized representative of the Commission or by an authorized officer.

(2) After examination and removal of the tag by an authorized representative of the Commission or an authorized officer, the Pacific halibut:

(a) may be retained for personal use; or

(b) may be sold only if the Pacific halibut is caught during commercial Pacific halibut fishing and complies with the other commercial fishing provisions of these Regulations.

(3) Any Pacific halibut that bears a Commission external tag will not count against commercial fishing period limits, Individual Vessel Quota (IVQ), Individual Transferable Quota (ITQ), Community Development Quota (CDQ), or Individual Fishing Quota (IFQ), and are not subject to size limits in these regulations, but should still be recorded in the landing record.

(4) Any Pacific halibut that bears a Commission external tag will not count against recreational (sport) daily bag limits or possession limits, may be retained outside of recreational (sport) fishing seasons, and are not subject to size limits in these regulations.

(5) Any Pacific halibut that bears a Commission external tag will not count against daily bag limits, possession limits, or fishery limits in the fisheries described in Section 22(1)(c), Section 23, or Section 24.

(1) The fishing periods for each IPHC Regulatory Area apply where the fishery limits specified in Section 5 have not been taken.

(2) Unless the Commission specifies otherwise, commercial fishing for Pacific halibut in all IPHC Regulatory Areas may begin no earlier in the year than 06:00 local time on 26 March.

(3) All commercial fishing for Pacific halibut in all IPHC Regulatory Areas shall cease for the year at 23:59 local time on 7 December.

(4) Regulations pertaining to the non-tribal directed commercial fishing  2 periods in IPHC Regulatory Area 2A will be promulgated by NOAA Fisheries and published in the Federal Register . This fishery will occur between the dates and times listed in paragraphs (2) and (3) of this Section.

(5) Notwithstanding paragraph (4) of this Section, an incidental catch fishery  3 is authorized during the sablefish seasons in IPHC Regulatory Area 2A in accordance with regulations promulgated by NOAA Fisheries. This fishery will occur between the dates and times listed in paragraphs (2) and (3) of this Section.

(6) Notwithstanding paragraph (4) of this Section, an incidental catch fishery is authorized during salmon troll seasons in IPHC Regulatory Area 2A in accordance with regulations promulgated by NOAA Fisheries. This fishery will occur between the dates and times listed in paragraphs (2) and (3) of this Section.

All waters in the Bering Sea north of 55°00′00″ N latitude in Isanotski Strait that are enclosed by a line from Cape Sarichef Light (54°36′00″ N latitude, 164°55′42″ W longitude) to a point at 56°20′00″ N latitude, 168°30′00″ W longitude; thence to a point at 58°21′25″ N latitude, 163°00′00″ W longitude; thence to Strogonof Point (56°53′18″ N latitude, 158°50′37″ W longitude); and then along the northern coasts of the Alaska Peninsula and Unimak Island to the point of origin at Cape Sarichef Light are closed to Pacific halibut fishing and no person shall fish for Pacific halibut therein or have Pacific halibut in his/her possession while in those waters except in the course of a continuous transit across those waters. All waters in Isanotski Strait between 55°00′00″ N latitude and 54°49′00″ N latitude are closed to Pacific halibut fishing.

(1) No person shall engage in fishing for Pacific halibut in any IPHC Regulatory Area other than during the fishing periods set out in Section 9 in respect of that area.

(2) No person shall land or otherwise retain Pacific halibut caught outside a fishing period applicable to the IPHC Regulatory Area where the Pacific halibut was taken.

(3) Subject to paragraphs (7), (8), (9), and (10) of Section 17, these Regulations do not prohibit fishing for any species of fish other than Pacific halibut during the closed periods.

(4) Notwithstanding paragraph (3), no person shall have Pacific halibut in his/her possession while fishing for any other species of fish during the closed periods.

(5) No vessel shall retrieve any Pacific halibut fishing gear during a closed period if the vessel has any Pacific halibut on board.

(6) A vessel that has no Pacific halibut on board may retrieve any Pacific halibut fishing gear during the closed period after the operator notifies an authorized officer or an authorized representative of the Commission prior to that retrieval.

(7) After retrieval of Pacific halibut gear in accordance with paragraph (6), the vessel shall submit to a hold inspection at the discretion of the authorized officer or an authorized representative of the Commission.

(8) No person shall retain any Pacific halibut caught on gear retrieved in accordance with paragraph (6).

(9) No person shall possess Pacific halibut on board a vessel in an IPHC Regulatory Area during a closed period unless that vessel is in continuous transit to or within a port in which that Pacific halibut may be lawfully sold.

(10) Notwithstanding paragraphs (2), (4), (8), and (9) of this Section, in IPHC Regulatory Area 2B, a person may retain, possess, and land legal-sized Pacific halibut caught incidentally outside the commercial fishing period, provided that such retention:

(a) occurs only while fishing for species other than Pacific halibut using hook and line or trap gear authorized under regulations promulgated by Canada (DFO) and Conditions of Licence;

(b) occurs in accordance with regulations promulgated by Canada (DFO) and Conditions of Licence;

(c) does not result in total landings under this provision exceeding two percent (2%) of the IPHC Regulatory Area 2B commercial fishery limit specified in paragraph (2) of Section 5; and

(d) shall remain in effect through the end of the 2026/2027 closed period, unless extended by the Commission.

(1) Notwithstanding the fishery limits described in Section 5, regulations pertaining to the division of the IPHC Regulatory Area 2A fishery limit between the non-tribal directed commercial fishery and the incidental catch fishery as described in paragraphs (5) and (6) of Section 9 will be promulgated by NOAA Fisheries and published in the Federal Register .

(2) Notwithstanding the fishery limits described in Section 5, the IPHC Regulatory Area 2A non-tribal directed commercial fishery will close when NOAA Fisheries determines and announces in the Federal Register that the fishery limit has been or is projected to be reached, or on the date when fishing must cease as specified in Section 9, whichever is earlier.

(3) Notwithstanding the fishery limits described in Section 5, the commercial fishing in IPHC Regulatory Area 2B will close only when all Individual Vessel Quota (IVQ) and Individual Transferable Quota (ITQ) assigned by DFO are taken, or on the date when fishing must cease as specified in Section 9, whichever is earlier.

(4) Notwithstanding the fishery limits described in Section 5, IPHC Regulatory Areas 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E will each close only when all Individual Fishing Quota (IFQ) and all Community Development Quota (CDQ) issued by NOAA Fisheries have been taken, or on the date when fishing must cease as specified in Section 9, whichever is earlier.

(5) Notwithstanding the fishery limits described in Section 5, the total allowable catch of Pacific halibut that may be taken in the IPHC Regulatory Area 4E directed commercial fishery is equal to the combined annual fishery limits specified for the IPHC Regulatory Areas 4D and 4E CDQ fisheries and any IPHC Regulatory Area 4D IFQ received by transfer by a CDQ organization. The annual IPHC Regulatory Area 4D fishery limit will decrease by the equivalent amount of CDQ and IFQ received by transfer by a CDQ organization taken in IPHC Regulatory Area 4E in excess of the annual IPHC Regulatory Area 4E fishery limit.

(6) Notwithstanding the fishery limits described in Section 5, the total allowable catch of Pacific halibut that may be taken in the IPHC Regulatory Area 4D directed commercial fishery is equal to the combined annual fishery limits specified for IPHC Regulatory Areas 4C and 4D. The annual IPHC Regulatory Area 4C fishery limit will decrease by the equivalent amount of Pacific halibut taken in IPHC Regulatory Area 4D in excess of the annual IPHC Regulatory Area 4D fishery limit.

(1) No person shall fish for Pacific halibut from a vessel, nor land or retain Pacific halibut on board a vessel, used for commercial fishing in IPHC Regulatory Area 2A, unless issued a permit valid for fishing in IPHC Regulatory Area 2A by NOAA Fisheries according to 50 CFR 300 Subpart E.

(2) It shall be unlawful for any vessel to retain more Pacific halibut than authorized by that vessel's permit in any fishing period for which a fishing period limit is announced by NOAA Fisheries in the Federal Register .

(3) The operator of any vessel that fishes for Pacific halibut during a fishing period when fishing period limits are in effect must, upon commencing an offload of Pacific halibut to a commercial fish processor, completely offload all Pacific halibut on board said vessel to that processor and ensure that all Pacific halibut is weighed and reported on State fish tickets.

(4) The operator of any vessel that fishes for Pacific halibut during a fishing period when fishing period limits are in effect must, upon commencing an offload of Pacific halibut other than to a commercial fish processor, completely offload all Pacific halibut on board said vessel and ensure that all Pacific halibut are weighed and reported on State fish tickets.

(5) The provisions of paragraph (4) are not intended to prevent retail over-the-side sales to individual purchasers so long as all the Pacific halibut on board is ultimately offloaded and reported.

(6) Fishing period limits in IPHC Regulatory Area 2A will be promulgated by NOAA Fisheries and published in the Federal Register and apply only to the non-tribal directed commercial Pacific halibut fishery referred to in paragraph (4) of Section 9.

(1) Section 14 applies only to any person fishing for, or any vessel that is used to fish for, IPHC Regulatory Area 4E Community Development Quota (CDQ) Pacific halibut, IPHC Regulatory Area 4D CDQ Pacific halibut, or IPHC Regulatory Area 4D Individual Fishing Quota (IFQ) received by transfer by a CDQ organization provided that the total annual Pacific halibut catch of that person or vessel is landed at a port within IPHC Regulatory Areas 4E or 4D.

(2) A person may retain Pacific halibut taken with setline gear that are smaller than the size limit specified in Section 18, provided that no person may sell or barter such Pacific halibut.

(3) The manager of a CDQ organization that authorizes persons to harvest Pacific halibut in the IPHC Regulatory Area 4E or 4D CDQ fisheries or IFQ received by transfer by a CDQ organization must report to the Commission the total number and weight of undersized Pacific halibut taken and retained by such persons pursuant to paragraph (2) of this Section. This report, which shall include data and methodology used to collect the data, must be received by the Commission prior to 1 November of the year in which such Pacific halibut were harvested.

(1) The operator of any vessel that fishes for Pacific halibut in IPHC Regulatory Areas 4A, 4B, 4C, or 4D must obtain a vessel clearance before fishing in any of these areas, and before the landing of any Pacific halibut caught in any of these areas, unless specifically exempted in paragraphs (10), (13), (14), (15), or (16).

(2) An operator obtaining a vessel clearance required by paragraph (1) must obtain the clearance in person from the authorized clearance personnel and sign the IPHC form documenting that a clearance was obtained, except that when the clearance is obtained via VHF radio referred to in paragraphs (5), (8), and (9), the authorized clearance personnel must sign the IPHC form documenting that the clearance was obtained.

(3) The vessel clearance required under paragraph (1) prior to fishing in IPHC Regulatory Area 4A may be obtained only at Nazan Bay on Atka Island, Dutch Harbor, or Akutan, Alaska, from the authorized clearance personnel.

(4) The vessel clearance required under paragraph (1) prior to fishing in IPHC Regulatory Area 4B may only be obtained at Nazan Bay on Atka Island or Adak, Alaska, from the authorized clearance personnel.

(5) The vessel clearance required under paragraph (1) prior to fishing in IPHC Regulatory Area 4C or 4D may be obtained only at St. Paul or St. George, Alaska, from the authorized clearance personnel by VHF radio and allowing the person contacted to confirm visually the identity of the vessel.

(6) The vessel operator shall specify the specific regulatory area in which fishing will take place.

(7) Before unloading any Pacific halibut caught in IPHC Regulatory Area 4A, a vessel operator may obtain the clearance required under paragraph (1) only in Dutch Harbor or Akutan, Alaska, by contacting the authorized clearance personnel.

(8) Before unloading any Pacific halibut caught in IPHC Regulatory Area 4B, a vessel operator may obtain the clearance required under paragraph (1) only in Nazan Bay on Atka Island or Adak, by contacting the authorized clearance personnel by VHF radio or in person.

(9) Before unloading any Pacific halibut caught in IPHC Regulatory Areas 4C and 4D, a vessel operator may obtain the clearance required under paragraph (1) only in St. Paul, St. George, Dutch Harbor, or Akutan, Alaska, either in person or by contacting the authorized clearance personnel. The clearances obtained in St. Paul or St. George, Alaska, can be obtained by VHF radio and allowing the person contacted to confirm visually the identity of the vessel.

(10) Any vessel operator who complies with the requirements in Section 16 for possessing Pacific halibut on board a vessel that was caught in more than one regulatory area in IPHC Regulatory Area 4 is exempt from the clearance requirements of paragraph (1) of this Section, provided that:

(a) the operator of the vessel obtains a vessel clearance prior to fishing in IPHC Regulatory Area 4 in either Dutch Harbor, Akutan, St. Paul, St. George, Adak, or Nazan Bay on Atka Island by contacting the authorized clearance personnel. The clearance obtained in St. Paul, St. George, Adak, or Nazan Bay on Atka Island can be obtained by VHF radio and allowing the person contacted to confirm visually the identity of the vessel. This clearance will list the areas in which the vessel will fish; and

(b) before unloading any Pacific halibut from IPHC Regulatory Area 4, the vessel operator obtains a vessel clearance from Dutch Harbor, Akutan, St. Paul, St. George, Adak, or Nazan Bay on Atka Island by contacting the authorized clearance personnel. The clearance obtained in St. Paul or St. George can be obtained by VHF radio and allowing the person contacted to confirm visually the identity of the vessel. The clearance obtained in Adak or Nazan Bay on Atka Island can be obtained by VHF radio.

(11) Vessel clearances shall be obtained between 0600 and 1800 local time.

(12) No Pacific halibut shall be on board the vessel at the time of the clearances required prior to fishing in IPHC Regulatory Area 4.

(13) Any vessel that is used to fish for Pacific halibut only in IPHC Regulatory Area 4A and lands its total annual Pacific halibut catch at a port within IPHC Regulatory Area 4A is exempt from the clearance requirements of paragraph (1).

(14) Any vessel that is used to fish for Pacific halibut only in IPHC Regulatory Area 4B and lands its total annual Pacific halibut catch at a port within IPHC Regulatory Area 4B is exempt from the clearance requirements of paragraph (1).

(15) Any vessel that is used to fish for Pacific halibut only in IPHC Regulatory Areas 4C or 4D or 4E and lands its total annual Pacific halibut catch at a port within IPHC Regulatory Areas 4C, 4D, 4E, or the closed area defined in Section 10, is exempt from the clearance requirements of paragraph (1).

(16) Any vessel that carries a NOAA Fisheries observer, a NOAA Fisheries electronic monitoring system, or a transmitting VMS transmitter while fishing for Pacific halibut in IPHC Regulatory Areas 4A, 4B, 4C, or 4D and until all Pacific halibut caught in any of these IPHC Regulatory Areas is landed, is exempt from the clearance requirements of paragraph (1) of this Section, provided that:

(a) the operator of the vessel complies with NOAA Fisheries' observer or electronic monitoring regulations published at 50 CFR Subpart E, or vessel monitoring system regulations published at 50 CFR 679.28(f)(3), (4) and (5); and

(b) the operator of the vessel notifies NOAA Fisheries Office for Law Enforcement at 800-304-4846 (select option 1 to speak to an Enforcement Data Clerk) between the hours of 0600 and 0000 (midnight) local time within 72 hours before fishing for Pacific halibut in IPHC Regulatory Areas 4A, 4B, 4C, or 4D and receives a VMS confirmation number.

(1) Except as provided in this Section, no person shall possess at the same time on board a vessel Pacific halibut caught in more than one IPHC Regulatory Area.

(2) Pacific halibut caught in more than one of the IPHC Regulatory Areas 2C, 3A, 3B, 4A, 4B, 4C, 4D, or 4E may be possessed on board a vessel at the same time only if:

(a) authorized by NOAA Fisheries regulations published at 50 CFR 679.7(f)(4); and

(b) the operator of the vessel identifies the regulatory area in which each Pacific halibut on board was caught by separating Pacific halibut from different areas in the hold, tagging Pacific halibut, or by other means.

(1) No person shall fish for Pacific halibut using any gear other than hook and line gear,

(a) except that a person may retain Pacific halibut taken with longline or single trap gear if such retention is authorized by DFO as defined by Pacific Fishery Regulations and Conditions of Licence; or

(b) except that a person may retain Pacific halibut taken with longline or single pot gear if such retention is authorized by NOAA Fisheries regulations published at 50 CFR part 679.

(2) No person shall possess Pacific halibut taken with any gear other than hook and line gear,

(a) except that a person may possess Pacific halibut taken with longline or single trap gear if such retention is authorized by DFO as defined by Pacific Fishery Regulations and Conditions of Licence; or

(b) except that a person may possess Pacific halibut taken with longline or single pot gear if such possession is authorized by NOAA Fisheries regulations published at 50 CFR part 679.

(3) No person shall possess Pacific halibut while on board a vessel carrying any trawl nets.

(4) All gear marker buoys carried on board or used by any United States of America vessel used for Pacific halibut fishing shall be marked with one of the following:

(a) the vessel's State license number; or

(b) the vessel's registration number.

(5) The markings specified in paragraph (4) shall be in characters at least four inches in height and one-half inch in width in a contrasting color visible above the water and shall be maintained in legible condition.

(6) All gear marker buoys carried on board or used by a Canadian vessel used for Pacific halibut fishing shall be:

(a) floating and visible on the surface of the water; and

(b) legibly marked with the identification plate number of the vessel engaged in commercial fishing from which that setline is being operated.

(7) No person on board a vessel used to fish for any species of fish anywhere in IPHC Regulatory Area 2A during the 72-hour period immediately before the fishing period for the non-tribal directed commercial fishery shall catch or possess Pacific halibut anywhere in those waters during that Pacific halibut fishing period unless, prior to the start of the Pacific halibut fishing period, the vessel has removed its gear from the water and has either:

(a) made a landing and completely offloaded its catch of other fish; or

(b) submitted to a hold inspection by an authorized officer.

(8) No vessel used to fish for any species of fish anywhere in IPHC Regulatory Area 2A during the 72-hour period immediately before the fishing period for the non-tribal directed commercial fishery may be used to catch or possess Pacific halibut anywhere in those waters during that Pacific halibut fishing period unless, prior to the start of the Pacific halibut fishing period, the vessel has removed its gear from the water and has either:

(a) made a landing and completely offloaded its catch of other fish; or

(b) submitted to a hold inspection by an authorized officer.

(9) No person on board a vessel used to fish for any species of fish anywhere in IPHC Regulatory Areas 2B, 2C, 3A, 3B, 4A, 4B, 4C, 4D, or 4E during the 72-hour period immediately before the opening of the Pacific halibut fishing season shall catch or possess Pacific halibut anywhere in those areas until the vessel has removed all of its gear from the water and has either:

(a) made a landing and completely offloaded its entire catch of other fish; or

(b) submitted to a hold inspection by an authorized officer.

(10) No vessel used to fish for any species of fish anywhere in IPHC Regulatory Areas 2B, 2C, 3A, 3B, 4A, 4B, 4C, 4D, or 4E during the 72-hour period immediately before the opening of the Pacific halibut fishing season may be used to catch or possess Pacific halibut anywhere in those areas until the vessel has removed all of its gear from the water and has either:

(a) made a landing and completely offloaded its entire catch of other fish; or

(b) submitted to a hold inspection by an authorized officer.

(11) Notwithstanding any other provision in these Regulations, a person may retain, possess and dispose of Pacific halibut taken with trawl gear only as authorized by Prohibited Species Donation regulations of NOAA Fisheries.

(1) No person shall take or possess any Pacific halibut that:

(a) with the head on, is less than 32 inches (81.3 cm) as measured in a straight line, passing over the pectoral fin from the tip of the lower jaw with the mouth closed, to the extreme end of the middle of the tail, as illustrated in Figure 2; or

(b) with the head removed, is less than 24 inches (61.0 cm) as measured from the base of the pectoral fin at its most anterior point to the extreme end of the middle of the tail, as illustrated in Figure 2.

(2) No person on board a vessel fishing for, or tendering, Pacific halibut in any IPHC Regulatory Area shall possess any Pacific halibut that has had its head removed, except that Pacific halibut frozen at sea with its head removed may be possessed on board a vessel by persons in IPHC Regulatory Areas 2B, 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E if authorized by Federal regulations.

(3) The size limit in paragraph (1)(b) will not be applied to any Pacific halibut that has had its head removed after the operator has landed the Pacific halibut.

(1) The operator of any U.S. vessel fishing for Pacific halibut that has an overall length of 26 feet (7.9 meters) or greater shall maintain an accurate log of Pacific halibut fishing operations.

(2) The operator of a vessel fishing in waters in and off Alaska must use one of the following logbooks:

(a) IPHC Pacific halibut logbook (or logbook previously provided by IPHC) or IPHC-approved electronic equivalent;

(b) catcher vessel longline and pot gear Daily Fishing Logbook, or catcher/processor longline and pot gear Daily Cumulative Production Logbook, in electronic or paper form, provided or approved by NOAA Fisheries;

(c) hook-and-line logbook provided by Alaska Longline Fishermen's Association; or

(d) Alaska Department of Fish and Game (ADFG) longline-pot logbook.

(3) The operator of a vessel fishing in IPHC Regulatory Area 2A must use either:

(a) IPHC Pacific halibut logbook (or logbook previously provided by IPHC) or IPHC-approved electronic equivalent;

(b) Oregon Department of Fish and Wildlife (ODFW) Fixed Gear Logbook; or

(c) Pacific Coast Groundfish non-trawl logbook provided by NOAA Fisheries.

(4) The logbooks referred to in paragraphs (2) and (3) must include the following information:

(a) the name of the vessel and the State (ADFG, WDFW, ODFW, or CDFW) or Tribal ID number;

(b) the date(s) upon which the fishing gear is set or retrieved;

(c) the latitude and longitude coordinates for each set;

(d) the number of skates deployed or retrieved, and number of skates lost; and

(e) the total weight or number of Pacific halibut retained for each set.

(5) The logbooks referred to in paragraphs (2) and (3) shall be:

(a) maintained on board the vessel;

(b) updated not later than 24 hours after 0000 (midnight) local time for each day fished and prior to the offloading or sale of Pacific halibut taken during that fishing trip;

(c) retained for a period of two years by the owner or operator of the vessel;

(d) open to inspection by an authorized officer or an authorized representative of the Commission upon demand;

(e) kept on board the vessel when engaged in Pacific halibut fishing, during transits to port of landing, and until the offloading of all Pacific halibut is completed; and

(f) submitted to the Commission within 30 days of the season closing date if not previously collected by an authorized representative of the Commission or otherwise made available to the Commission.

(6) The log referred to in paragraph (1) does not apply to the incidental Pacific halibut fishery during the salmon troll season in IPHC Regulatory Area 2A defined in paragraph (6) of Section 9.

(7) The operator of any Canadian vessel fishing for Pacific halibut, or retaining Pacific halibut caught incidentally pursuant to Section 11(10), shall maintain an accurate record in the British Columbia Integrated Groundfish Fishing Log.

(8) The log referred to in paragraph (7) must include the following information:

(a) the name of the vessel and the DFO vessel registration number;

(b) the date(s) upon which the fishing gear is set and retrieved;

(c) the latitude and longitude coordinates for each set;

(d) the number of skates deployed or retrieved, and number of skates lost; and

(e) the total weight or number of Pacific halibut retained for each set.

(9) The log referred to in paragraph (7) shall be:

(a) maintained on board the vessel;

(b) retained for a period of two years by the owner or operator of the vessel;

(c) open to inspection by an authorized officer or an authorized representative of the Commission upon demand;

(d) kept on board the vessel when engaged in Pacific halibut fishing, during transits to port of landing, and until the offloading of all Pacific halibut is completed;

(e) submitted to the DFO within seven days of offloading; and

(f) submitted to the Commission within seven days of the final offload if not previously collected by an authorized representative of the Commission.

(10) No person shall make a false entry in a log referred to in this Section.

(11) Writing in a log referred to in this Section shall be clear and legible.

(1) No person shall receive Pacific halibut caught in IPHC Regulatory Area 2A from a United States of America vessel that does not have on board the permit required by Section 13(1).

(2) No person shall possess on board a vessel a Pacific halibut other than whole or with gills and entrails removed, except that this paragraph shall not prohibit the possession on board a vessel of:

(a) Pacific halibut cheeks cut from Pacific halibut caught by persons authorized to process the Pacific halibut on board in accordance with NOAA Fisheries regulations published at 50 CFR part 679;

(b) fillets from Pacific halibut offloaded in accordance with this Section that are possessed on board the harvesting vessel in the port of landing up to 1800 local time on the calendar day following the offload;  4 and

(c) Pacific halibut with their heads removed in accordance with Section 18.

(3) No person shall offload Pacific halibut from a vessel unless the gills and entrails have been removed prior to offloading. 5

(4) It shall be the responsibility of a vessel operator who lands Pacific halibut to continuously and completely offload at a single offload site all Pacific halibut on board the vessel.

(5) A registered buyer (as that term is defined in regulations promulgated by NOAA Fisheries and codified at 50 CFR part 679) who receives Pacific halibut harvested in Individual Fishing Quota (IFQ) and Community Development Quota (CDQ) fisheries in IPHC Regulatory Areas 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E, directly from the vessel operator that harvested such Pacific halibut must weigh all the Pacific halibut received and record the following information on Federal catch reports: date of offload; name of vessel; vessel number (State, Tribal or Federal, not IPHC vessel number); scale weight obtained at the time of offloading, including the scale weight (in pounds) of Pacific halibut purchased by the registered buyer, the scale weight (in pounds) of Pacific halibut offloaded in excess of the IFQ or CDQ, the scale weight of Pacific halibut (in pounds) retained for personal use or for future sale, and the scale weight (in pounds) of Pacific halibut discarded as unfit for human consumption. All Pacific halibut harvested in IFQ or CDQ fisheries in Areas IPHC Regulatory 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E, must be weighed with the head on and the head-on weight must be recorded on Federal catch reports as specified in this paragraph, unless the Pacific halibut is frozen at sea and exempt from the head-on landing requirement at Section 18(2).

(6) The first recipient, commercial fish processor, or buyer in the United States of America who purchases or receives Pacific halibut directly from the vessel operator that harvested such Pacific halibut must weigh and record all Pacific halibut received and record the following information on State fish tickets: the date of offload; vessel number (State or Federal, not IPHC vessel number) or Tribal ID number; total weight obtained at the time of offload including the weight (in pounds) of Pacific halibut purchased; the weight (in pounds) of Pacific halibut offloaded in excess of the IFQ, CDQ, or fishing period limits; the weight of Pacific halibut (in pounds) retained for personal use or for future sale; and the weight (in pounds) of Pacific halibut discarded as unfit for human consumption. All Pacific halibut harvested in fisheries in IPHC Regulatory Areas 2A, 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E must be weighed with the head on and the head-on weight must be recorded on State fish tickets as specified in this paragraph, unless the Pacific halibut is frozen at sea and exempt from the head-on landing requirement at Section 18(2).

(7) For Pacific halibut landings made in Alaska, the requirements as listed in paragraphs (5) and (6) can be met by recording the information in the Interagency Electronic Reporting Systems, eLandings, in accordance with NOAA Fisheries regulation published at 50 CFR part 679.

(8) The master or operator of a Canadian vessel that was engaged in Pacific halibut fishing must weigh and record all Pacific halibut on board said vessel at the time offloading commences and record on Provincial fish tickets or Federal catch reports: the date; locality; name of vessel; the name(s) of the person(s) from whom the Pacific halibut was purchased; and the scale weight obtained at the time of offloading of all Pacific halibut on board the vessel including the pounds purchased, pounds in excess of Individual Vessel Quota (IVQ) or Individual Transferable Quota (ITQ), pounds retained for personal use, and pounds discarded as unfit for human consumption. All Pacific halibut must be weighed with the head on and the head-on weight must be recorded on the Provincial fish tickets or Federal catch reports as specified in this paragraph, unless the Pacific halibut is frozen at sea and exempt from the head-on landing requirement at Section 18(2).

(9) No person shall make a false entry on a State or Provincial fish ticket or a Federal catch or landing report referred to in paragraphs (5), (6), and (8) of this Section.

(10) A copy of the fish tickets or catch reports referred to in paragraphs (5), (6), and (8) shall be:

(a) retained by the person making them for a period of three years from the date the fish tickets or catch reports are made; and

(b) open to inspection by an authorized officer or an authorized representative of the Commission.

(11) No person shall possess any Pacific halibut taken or retained in contravention of these Regulations.

(12) When Pacific halibut are landed to other than a commercial fish processor, the records required by paragraph (6) shall be maintained by the operator of the vessel from which that Pacific halibut was caught, in compliance with paragraph (10).

(13) No person shall tag Pacific halibut unless the tagging is authorized by IPHC or by a Federal or State agency.

(1) The unloading and weighing of Pacific halibut may be subject to the supervision of authorized officers to assure the fulfillment of the provisions of these Regulations.

(2) The unloading and weighing of Pacific halibut may be subject to sampling by an authorized representative of the Commission.

(1) Pacific halibut fishing in IPHC Regulatory Area Subarea 2A-1 by members of United States treaty Indian tribes located in the State of Washington shall be regulated under regulations promulgated by NOAA Fisheries and published in the Federal Register :

(a) Subarea 2A-1 includes the usual and accustomed fishing areas for Pacific Coast treaty tribes off the coast of Washington and all inland marine waters of Washington north of Point Chehalis (46°53.30′ N lat.), including Puget Sound. Boundaries of a tribe's fishing area may be revised as ordered by a United States Federal court;

(b) Section 13(1) does not apply to commercial fishing for Pacific halibut in Subarea 2A-1 by Indian tribes; and

(c) ceremonial and subsistence fishing for Pacific halibut in Subarea 2A-1 is permitted with hook and line gear from 1 January through 31 December.

(2) In IPHC Regulatory Area 2C, the Metlakatla Indian Community has been authorized by the United States Government to conduct a commercial Pacific halibut fishery within the Annette Islands Reserve. Fishing periods for this fishery are announced by the Metlakatla Indian Community and the Bureau of Indian Affairs. Landings in this fishery are accounted with the commercial landings for IPHC Regulatory Area 2C.

(3) Section 7 (careful release of Pacific halibut), Section 17 (fishing gear), except paragraphs (7) and (8) of Section 17, Section 18 (size limits), Section 19 (logs), and Section 20 (receipt and possession of Pacific halibut) apply to commercial fishing for Pacific halibut by Indian tribes.

(4) Regulations in paragraph (3) of this Section that apply to State fish tickets apply to Tribal tickets that are authorized by WDFW and ADFG.

(5) Commercial fishing for Pacific halibut is permitted with hook and line gear between the dates specified in Section 9 paragraphs (2) and (3), or until the applicable fishery limit specified in Section 5 is taken, whichever occurs first.

(1) Fishing for Pacific halibut for food, social and ceremonial purposes by Indigenous groups in IPHC Regulatory Area 2B shall be governed by the Fisheries Act of Canada and regulations as amended from time to time.

(1) Customary and traditional fishing for Pacific halibut in IPHC Regulatory Areas 2C, 3A, 3B, 4A, 4B, 4C, 4D, and 4E shall be governed pursuant to regulations promulgated by NOAA Fisheries and published in 50 CFR part 300.

(2) Customary and traditional fishing is authorized from 1 January through 31 December.

(1) No person shall engage in recreational (sport) fishing for Pacific halibut using gear other than a single line with no more than two hooks attached; or a spear.

(2) Any size limit promulgated under IPHC or domestic regulations shall be measured in a straight line passing over the pectoral fin from the tip of the lower jaw with the mouth closed, to the extreme end of the middle of the tail as depicted in Figure 2.

(3) Any Pacific halibut brought aboard a vessel and not immediately returned to the sea with a minimum of injury will be included in the daily bag limit of the person catching the Pacific halibut.

(4) No person may possess Pacific halibut on a vessel while fishing in a closed area.

(5) No Pacific halibut caught by recreational (sport) fishing shall be offered for sale, sold, traded, or bartered.

(6) No Pacific halibut caught in recreational (sport) fishing shall be possessed on board a vessel when other fish or shellfish aboard said vessel are destined for commercial use, sale, trade, or barter.

(7) The operator of a charter vessel shall be liable for any violations of these Regulations committed by an angler on board said vessel. In Alaska, the charter vessel guide, as defined in 50 CFR 300.61 and referred to in 50 CFR 300.65, 300.66, and 300.67, shall be liable for any violation of these Regulations committed by an angler on board a charter vessel.

(1) The Commission shall determine and announce closing dates to the public for any area in which the fishery limits promulgated by NOAA Fisheries are estimated to have been taken.

(2) When the Commission has determined that a subquota under paragraph (8) of this Section is estimated to have been taken, and has announced a date on which the season will close, no person shall recreational (sport) fish for Pacific halibut in that area after that date for the rest of the year, unless a reopening of that area for recreational (sport) Pacific halibut fishing is scheduled in accordance with the Catch Sharing Plan for IPHC Regulatory Area 2A, or announced by the Commission.

(3) No person shall fish for Pacific halibut from a vessel, nor land or retain Pacific halibut on board a vessel, used as a charter vessel in IPHC Regulatory Area 2A, unless issued a permit valid for fishing in IPHC Regulatory Area 2A by NOAA Fisheries according to 50 CFR 300 Subpart E.

(4) In California, Oregon, or Washington, no person shall fillet, mutilate, or otherwise disfigure a Pacific halibut in any manner that prevents the determination of minimum size or the number of fish caught, possessed, or landed.

(5) The possession limit on a vessel for Pacific halibut in the waters off the coast of Washington is the same as the daily bag limit. The possession limit for Pacific halibut on land in Washington is two daily bag limits.

(6) The possession limit on a vessel for Pacific halibut caught in the waters off the coast of Oregon is the same as the daily bag limit. The possession limit for Pacific halibut on land in Oregon is three daily bag limits.

(7) The possession limit on a vessel for Pacific halibut caught in the waters off the coast of California is one daily bag limit. The possession limit for Pacific halibut on land in California is one daily bag limit.

(8) In Convention waters of the Washington Puget Sound and the U.S. Convention waters in the Strait of Juan de Fuca subarea, the recreational (sport) fishing season opens on the first Thursday in April and runs through 30 June, seven days per week. NOAA Fisheries may modify these dates in-season. The daily bag limit is one Pacific halibut of any size per person. The Washington Puget Sound and the U.S. Convention waters in the Strait of Juan de Fuca subarea is defined in 50 CFR 300.63(c)(5)(i)(A).

(9) In Convention waters off California the recreational (sport) fishing season is from 1 April through 15 November, seven days per week, in the Northern California Coast subarea and from 1 April to 31 December, seven days per week, in the South of Point Arena subarea. NOAA Fisheries may modify these dates in-season. The daily bag limit is one Pacific halibut of any size per person. The California subareas are defined in 50 CFR 300.63(c)(5)(iii).

(10) Additional regulations describing fishing periods, fishery limits, fishing dates, and daily bag limits are promulgated by NOAA Fisheries and published in the Federal Register . 6

(1) In all waters off British Columbia:7,8

(a) the recreational (sport) fishing season will open on 1 February;

(b) the recreational (sport) fishing season will close when the recreational (sport) fishery limit allocated by DFO is taken, or 31 December, whichever is earlier; and

(c) the daily bag limit is two (2) Pacific halibut of any size per day, per person, and may be increased to a daily bag limit of three (3) Pacific halibut per day, per person on or after 1 August. This provision shall remain in effect through 2026, unless extended by a vote of the Commission.

(2) In British Columbia, no person shall fillet, mutilate, or otherwise disfigure a Pacific halibut in any manner that prevents the determination of minimum size or the number of fish caught, possessed, or landed.

(3) The possession limit for Pacific halibut in the waters off the coast of British Columbia is three Pacific halibut. 7   8

(1) In Convention waters in and off Alaska:  9   10

(a) the recreational (sport) fishing season is from 1 February to 31 December;

(b) the daily bag limit is two Pacific halibut of any size per day per person unless a more restrictive bag limit applies in Commission regulations or Federal regulations at 50 CFR 300.65;

(c) no person may possess more than two daily bag limits;

(d) no person shall possess on board a vessel, including charter vessels and pleasure craft used for fishing, Pacific halibut that have been filleted, mutilated, or otherwise disfigured in any manner, except that each Pacific halibut may be cut into no more than 2 ventral pieces, 2 dorsal pieces, and 2 cheek pieces, with a patch of skin on each piece, naturally attached. Either one dorsal piece or one ventral piece from one Pacific halibut on board may be consumed;

(e) Pacific halibut in excess of the possession limit in paragraph (1)(c) of this Section may be possessed on a vessel that does not contain recreational (sport) fishing gear, fishing rods, hand lines, or gaffs;

(f) Pacific halibut harvested on a charter vessel fishing trip in IPHC Regulatory Areas 2C or 3A must be retained on board the charter vessel on which the Pacific halibut was caught until the end of the charter vessel fishing trip as defined at 50 CFR 300.61;

(g) guided angler fish (GAF), as described at 50 CFR 300.65, may be used to allow a charter vessel angler to harvest additional Pacific halibut up to the limits in place for unguided anglers, and are exempt from the requirements in paragraphs (2) and (3) of this Section;

(h) if there is an annual limit on the number of Pacific halibut that may be retained by a charter vessel angler as defined at 50 CFR 300.61, for purposes of enforcing the annual limit, each charter vessel angler must:

(1) maintain a nontransferable harvest record in the angler's possession if retaining a Pacific halibut for which an annual limit has been established. Such harvest record must be maintained either on the angler's State of Alaska recreational (sport) fishing license, an ADFG approved electronic harvest record, or on a Sport Fishing Harvest Record Card obtained, without charge, from ADFG offices, the ADFG website, or fishing license vendors;

(2) immediately upon retaining a Pacific halibut for which an annual limit has been established, permanently and legibly record the date, location (IPHC Regulatory Area), and species of the catch (Pacific halibut) on the harvest record; and

(3) record the information required by paragraph 1(h)(2) on any duplicate or additional recreational (sport) fishing license issued to the angler, duplicate electronic harvest record, or any duplicate or additional Sport Fishing Harvest Record Card obtained by the angler for all Pacific halibut previously retained during that year that were subject to the harvest record reporting requirements of this Section; and

(i) in IPHC Regulatory 3A:

(1) a “charter halibut permit,” as defined at 50 CFR 300.61, may only be used for one charter vessel fishing trip in which Pacific halibut are caught and retained per calendar day;

(2) a “charter vessel,” as defined at 50 CFR 300.61 and in Section 3(d), may only be used for one charter vessel fishing trip in which Pacific halibut are caught and retained per calendar day; and

(3) for purposes of subsections (1) and (2) of this paragraph, a “charter vessel fishing trip” is defined as the time period between: (a) the first time Pacific halibut are caught and retained on a charter vessel by a charter vessel angler (as defined at 50 CFR 300.61); and (b) whichever comes first: 2359 (Alaska local time) on the same calendar day that the charter vessel fishing trip began; when any charter vessel angler is offloaded from the charter vessel; or when Pacific halibut are offloaded from the charter vessel.

(2) For guided recreational (sport) fishing (as referred to in 50 CFR 300.65) in IPHC Regulatory Area 2C:

(a) no person on board a charter vessel (as referred to in 50 CFR 300.65) shall catch and retain more than one Pacific halibut per calendar day;

(b) no person on board a charter vessel (as referred to in 50 CFR 300.65) shall catch and retain any Pacific halibut that with head on is greater than 34 inches (86.4 cm) and less than 80 inches (203.2 cm) as measured in a straight line, passing over the pectoral fin from the tip of the lower jaw with mouth closed, to the extreme end of the middle of the tail; and

(c) no person on board a charter vessel (as referred to in 50 CFR 300.65 and defined in Section 3(d)) may catch and retain Pacific halibut the following Thursdays in 2026: 18 June through 10 September.

(3) For guided recreational (sport) fishing (as referred to in 50 CFR 300.65) in IPHC Regulatory Area 3A:

(a) no person on board a charter vessel (as referred to in 50 CFR 300.65 and defined in Section 3(d)) shall catch and retain more than two Pacific halibut per calendar day;

(b) at least one of the retained Pacific halibut must have a head-on length of no more than 27 inches (68.6 cm) as measured in a straight line, passing over the pectoral fin from the tip of the lower jaw with mouth closed, to the extreme end of the middle of the tail. If a person recreational (sport) fishing on a charter vessel in IPHC Regulatory Area 3A retains only one Pacific halibut in a calendar day, that Pacific halibut may be of any length; and

(c) no person on board a charter vessel (as referred to in 50 CFR 300.65 and defined in Section 3(d)) may catch and retain Pacific halibut on any Wednesday, or on the following Tuesdays, in 2026: 2 June through 25 August.

These Regulations shall supersede all previous regulations of the Commission, and these Regulations shall be effective each succeeding year until superseded.

NMFS, in collaboration with the Gulf Fishery Management Council (Gulf Council) manages reef fish in Federal waters of the Gulf under the Fishery Management Plan (FMP) for the Reef Fish Resources of the Gulf (Reef Fish FMP). In Gulf and Atlantic Federal waters, NMFS, in collaboration with the Gulf Council and South Atlantic Fishery Management Council, manages CMP fish species under the FMP for Coastal Migratory Pelagic Resources of the Gulf and Atlantic Region (CMP FMP). NMFS implements the FMPs through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1801 et seq. ). This action is taken under the authority of section 303(a)(5) of the Magnuson-Steven Act, which pertains to the specification of pertinent fishery data that must be submitted to the Secretary of Commerce.

In 2014, NMFS implemented management measures contained in a framework action under the Reef Fish FMP and the CMP FMP (Headboat Reporting Framework), which modified recordkeeping and reporting provisions for an owner or operator of a headboat that has been issued a for-hire permit for Gulf reef fish or Gulf CMP species (2014 Rule; 79 FR 6097, February 3, 2014). If selected by NMFS to participate in the Southeast Region Headboat Survey (SRHS), a headboat owner or operator was required to submit an electronic fishing report weekly, or at shorter intervals if notified by the Science and Research Director of NMFS' Southeast Fisheries Science Center (SEFSC). The selected headboat owners or operators were required to submit an electronic fishing report to NMFS via the internet by the Sunday following the end of each reporting week, which runs from Monday through Sunday; in other words, reports were due within 7 days after a reporting week ends. If the reports were not submitted on time, the owner or operator of the vessel was prohibited from harvesting or possessing the applicable species until any delinquent electronic fishing reports were submitted to NMFS. The purpose of the Headboat Reporting Framework was to obtain more timely fishing information from headboats to better monitor recreational annual catch limits, improve stock assessments, and improve compliance with reporting in Gulf recreational for-hire fisheries.

On July 21, 2020, NMFS published a final rule to modify these reporting requirements (85 FR 44005; 2020 Rule). The 2020 Rule expanded the reporting requirement to all vessels issued Gulf for-hire permits for Gulf reef fish or Gulf CMP species and required the submission of an electronic fishing report after every for-hire trip, a notification to NMFS (trip declaration) each time the vessel left the dock, and an operating vessel monitoring system (VMS). The requirements to submit the fishing reports and trip declarations became effective on January 5, 2021 (86 FR 51014, September 14, 2021), and the VMS requirement became effective on March 1, 2022 (86 FR 60374, November 2, 2021).

Several Gulf for-hire permit holders filed a lawsuit challenging the final rule, and on February 23, 2023, the U.S. Court of Appeals for the Fifth Circuit set aside the 2020 Rule, thereby invalidating the new reporting, declaration, and VMS requirements. The 2023 ruling restored the status quo before the 2020 Rule took effect, i.e., the requirements of the 2014 Rule. Accordingly, since the 2023 court decision, NMFS has directed permit holders to comply with the 2014 regulations, and this final rule formally reinserts the 2014 regulations applicable to recreational for-hire permits into the CFR.

As a result, Gulf for-hire vessels that NMFS selected to participate in the SRHS program are now required to submit electronic trip-level reports on a weekly basis by the following Sunday after the reporting week of Monday through Sunday. All other Gulf-hire vessels, if selected, must submit a weekly report on forms provided, postmarked no later than 7 days after the end of each week (Sunday).

However, the regulations at 50 CFR 622.26(b) and 622.374(b) currently still include the provisions vacated by the court of appeals and do not include the current requirements for vessels with the Gulf Federal for-hire permits. The regulations at 50 CFR 622.20(b)(1)(ii)(A) and 622.373(c)(1), which specify that permit renewal is contingent on reporting as required, also include provisions that were modified by the vacated final rule. This final rule removes the vacated provisions and reinstates the regulations that specify the current requirements for those vessels issued Gulf for-hire permits.

NMFS is issuing this rule pursuant to section 305(d) of the Magnuson-Stevens Act, because this action is necessary to remove vacated regulations in response to the decision of the Fifth Circuit issued on February 23, 2023. The NMFS Assistant Administrator has determined that this final rule is consistent with the Fifth Circuit's decision, the Reef Fish FMP and the CMP FMP, and other applicable law.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, because they are unnecessary. This action reinstates the regulatory text that was in place prior to the 2020 Rule vacated by the Fifth Circuit. NMFS is unable to consider public comment for an alternative to the action in this rule, because the court ruling does not allow discretion for NMFS to take other action in this case. Therefore, a public comment period is unnecessary in this case. The regulations implemented by the 2020 Rule are no longer in effect and this action is necessary to reflect the reporting requirements that have been in effect since the Fifth Circuit's decision.

This final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.

This final rule is considered an E.O. 14192 deregulatory action.

NMFS has determined that this action would 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. Therefore, consultation with Tribal officials under E.O. 13175 is not required, and the requirements of sections (5)(b) and (5)(c) of E.O. 13175 also do not apply. A Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2)(B) of E.O. 13175 is not required and has not been prepared.

Because prior notice and opportunity for public comment are not required under 5 U.S.C. 553, the regulatory flexibility analysis requirements of the Regulatory Flexibility Act at 5 U.S.C. 603-605 do not apply to this rule. Accordingly, no regulatory flexibility analysis is required and none has been prepared. When NMFS proposed the electronic reporting requirements for the vessels participating in the SRHS in 2014, the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that the action would not have a significant economic impact on a substantial number of small entities. NMFS addressed comments on the economic analysis in the 2014 Rule that implemented those requirements, which are the same requirements currently in effect because of the vacatur of the 2020 Rule.

This final rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This rule changes the existing requirements for the collections of information under 0648-0016, the Southeast Region Logbook Family of Forms. Specifically, this final rule removes regulatory requirements to: (1) submit a trip declaration and an electronic fishing report on a per-trip basis; (2) land at verified locations only; (3) submit a landing location request form if NMFS has not already verified a landing location; (4) install and maintain on the vessel an active VMS; (5) submit a form verifying successful installation and activation of a VMS unit; and (6) submit a form to request an exemption to the requirement to maintain an active VMS unit. Further, NMFS will not conduct the fishermen intercept survey used previously to validate data collected in the program. The estimated number of respondents, anticipated responses, burden, hours, or burden cost all are zero. NMFS did not request an extension through this revision of 0648-0016. The estimated public reporting burden for the remaining information collections under 0648-0016 remain unchanged and vary between components, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

NMFS invites the public and other Federal agencies to comment on proposed and continuing information collections, which helps with assessing the impact of information collection requirements and minimize the public's reporting burden.

To submit any written comments or recommendations for this information collection see FOR FURTHER INFORMATION CONTACT section or https://www.reginfo.gov/public/do/pramain. Find this information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function and entering the OMB Control Number—0648-0016.

Notwithstanding any other provision of the law, no person is required to respond to, nor will any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

For the reasons set out in the preamble, NMFS amends 50 CFR part 622 as follows: