On January 16, 2025, AMS published the final rule, “Poultry Grower Payment Systems and Capital Improvement Systems” (Payment Systems rule or final rule) (90 FR 5146, January 16, 2025,), to amend 9 CFR part 201 of its regulations under the Packers and Stockyards Act (P&S Act) (7 U.S.C. 181 et seq. ). The final rule was promulgated in support of Executive Order 14036 (86 FR 36987, July 14, 2021), which Executive Order 14337 revoked on August 13, 2025 (90 FR 40227, August 19, 2025).

The final rule: (1) prohibits livestock poultry dealers (LPDs) from reducing a grower's compensation based on the grower's ranking under a poultry grower ranking system; (2) establishes a presumptive violation of the P&S Act by LPDs when aggregate gross annual payments based upon a grower's ranking under a poultry grower ranking system exceeds a certain threshold; (3) holds LPDs to a duty of fair comparison when designing and operating their poultry grower ranking system and requires documentation of compliance with that duty; and (4) requires LPDs to provide certain disclosures when requesting or requiring that broiler growers make additional capital investments.

At the time of publication, AMS estimated the final rule would result in significant costs to both LPDs and poultry growers with no quantifiable benefits. 1 AMS acknowledged it could not rule out the possibility of increased compliance costs, fewer growers participating in the market, and/or reduced production efficiencies, all of which could lead to higher consumer prices. 2

In the explanatory statement accompanying the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 (Pub. L. 119-37), 3 Congress encouraged the Department to delay implementation of the final rule. 4

In alignment with Congressional direction, and given the significant estimated costs, and the policy and legal issues associated with the final rule, AMS is seeking public comment on delaying the effective date of the final rule to December 31, 2027, to allow for thorough consideration of these matters.

This proposed rule has been determined to be “significant” under Executive Order 12866, as supplemented by Executive Orders 13563 and 14192, and, therefore, has been accordingly reviewed by the Office of Management and Budget (OMB). As a required part of the regulatory process, AMS prepared an economic analysis of the costs and benefits of delaying the effective date of §§ 201.106, 110, 112, and 290.

AMS proposes to delay the effective date of the Payment Systems rule. The Payment Systems rule created four specific provisions including: § 201.106 regarding LPD responsibilities for the design of broiler grower compensation arrangements; § 201.110 regarding the fair operation of broiler grower ranking systems; § 201.112 regarding disclosure requirements for LPDs when requesting additional capital investments from broiler growers; and § 201.290 regarding severability.

AMS is proposing to delay the effective day of the Payment Systems rule to allow for thorough consideration of estimated costs and the policy and legal issues associated with the final rule.

When AMS finalized the Payment Systems rule, AMS explained there was uncertainty as to whether the benefits would outweigh the costs. 5 One factor that was difficult to determine was whether the provision that prevents LPDs from applying performance discounts (§ 201.106(a)) and the provision capping variation in performance premiums (§ 201.106(b)) would impact grower incentives. Research indicates growers tend to raise broilers more efficiently with tournament contracts than with other forms of contracts or when LPDs raise broilers in their own facilities. 6 However, there is no literature addressing how growers' incentives might change if performance discounts were not part of the tournament or if variability in performance payments were limited. If changes to tournament contracts due to the Payment Systems rule's amendments to subpart N result in even very small decreases in feed efficiency, costs from implementation of the amendments could be considerably larger than the value of the benefits to growers due to reduced variability in compensation.

AMS prepared an economic analysis of the costs and benefits of delaying the effective date of §§ 201.106, 110, 112, and 290. AMS estimated cost and benefits associated with the Payment Systems rule when it was made final in 2025. AMS provided quantitative estimates of direct administrative costs associated with the Payment Systems rule, and qualitative descriptions of indirect costs and benefits. This analysis follows the same analytical approach used in the final rule. AMS invites comments and data concerning the benefits and costs of delaying the effective date of the Payment Systems rule.

The updated estimates incorporate the latest industry parameters and wage rates while maintaining consistency with the methodology used. Hourly wage rates were established using the following Bureau of Labor Statistics (BLS) classifications for each labor category as follows (NAICS Code—OCC code—OCC Title): Management (3116—11-1020—General and Operations Managers) for live poultry dealers' managers, and Legal (3110—23-1011—Lawyers) for attorneys. 7 The average hourly wage rates used to estimate cost savings were updated from the final rule to include a 42.34 percent markup for benefits and are as follows: Management—$102.56, Legal—$145.93, Administrative—$48.38, and Information Technology—$101.72. For reference, the analysis in the final rule is described in detail in the Federal Register at 90 FR 5146 (see pages 5189-5206). 8

AMS expects that LPDs would incur $4.9 million in ongoing administrative costs for each of the first four years after the Payment Systems rule becomes effective and $4.1 million annually thereafter. Poultry growers would have approximately $249,000 in ongoing quantified administrative costs each year. Total ongoing administrative costs would be $5.2 million for the four years and $4.3 million thereafter.

AMS considered three alternatives to the proposed delay of §§ 201.106, 110, 112, and 290. The first alternative is the “do nothing” approach or maintaining the status quo. All regulations under the Packers and Stockyards Act would remain unchanged; that is, the Payment Systems rule would become effective on July 1, 2026. This first alternative forms the baseline against which AMS compares the other alternatives.

The second alternative is this proposed rule. AMS proposes to delay the effective date of the Payment Systems rule for 18 months. If finalized, the Payment Systems rule would become effective on December 31, 2027, rather than July 1, 2026.

AMS considered a third alternative, the 12-Month Delay alternative, which is similar to the preferred alternative, and proposes to delay the effective date of §§ 201.106, 110, 112, and 290 by 12 months (July 1, 2027) instead of 18 months (December 31, 2027).

With the proposed 18-month delay of the Poultry Systems rule, much of the first-year costs in the final rule that AMS considered are one-time setup and preparation activities that processors and growers would incur before the rule became effective. AMS believes many of these costs have likely already occurred, and therefore they are not affected by the delay; however, AMS welcomes comments for the industry related to these costs during the comment period of this proposed rule. The delay would affect recurring costs. The delay would save live poultry growers and LPDs administrative costs associated with the ongoing administrative costs that would otherwise occur in the first 18 months after the Payment Systems rule becomes effective.

Delaying the effective date for 18 months would shift all costs for both LPDs and growers back by 18-months. This proposed rule would enable LPDs to save $4.9 million and poultry growers to save $249,000 in administrative costs for a total of $5.2 million in the first year. They would save an additional $2.5 million and $125,000, respectively, in the second year for a total of $7.7 million. Administrative costs for LPDs were expected to decrease by $800,000 in the fifth year after the rule became effective. If the effective date is delayed 18 months, the decrease in costs will be delayed as well. Costs would be $800,000 higher in the fifth year and $400,000 in the sixth year for LPDs. This would result in a ten-year total cost savings of $6.1 million for LPDs and $374,000 for poultry growers; a combined savings of $6.5 million. Table 1 below summarizes cost savings to poultry growers and LPDs if the effective date of the Payment Systems rule is delayed until December 31, 2027.

The indirect benefits (cost savings) of this proposed rule represent the indirect benefits incurred during the 18-month period of the delay of the effective date. AMS expects that §§ 201.106, 110, and 112 include provisions that may require LPDs to change their existing business practices, which has the potential to affect the indirect costs of the Payment Systems rule. As discussed in the Payment Systems rule, AMS does not have sufficient data to make an inference on the number of complexes that would need to change business practices or the magnitude of any changes that would be required. 9

If LPDs modify existing grower compensation structures in response to § 201.106, changes in performance-based payments could adversely affect grower performance incentives and cause growers to produce broilers less efficiently. As a result, LPDs could face increased production costs. Even a very small change in efficiency could result in relatively large increases in the cost of producing broilers. Those costs could be passed on to consumers.

If AMS enforcement of § 201.112 has the effect of preventing broiler growers from making additional capital investments, then such decisions to forgo investment will likely result in fewer benefits for LPDs, and more for growers. AMS is not able to quantify these lost benefits (costs) to LPDs.

As the preferred alternative proposes to delay the effective date of the Payment Systems rule for 18 months, LPDs and growers may experience indirect benefits proportional to this delay, though AMS expects these indirect benefits to be small relative to the benefits associated with the Payments Systems rule.

There are unquantifiable benefits to the provisions regulating LPDs in §§ 201.106, 110, and 112, which would be foregone in the 18-month period in which the Payment Systems rule would be delayed under the preferred alternative. Section 201.106 could benefit growers from increased clarity and certainty about the lowest possible revenue and reduce variability in outcomes under a growing arrangement. Section 201.110 may benefit broiler growers through improved fairness in comparison. Section 201.112 may provide broiler growers with better information to make financial decisions. The size of these unquantifiable benefits would be directly related to the extent of these reductions. However, AMS does not have sufficient data to make an inference on the number of complexes that would change business practices or the magnitude of any changes that would be required.

AMS expects broiler growers would benefit from the Payment Systems rule, though AMS is unable to predict the size of these benefits with certainty. The indirect benefits of the Payment Systems rule would still occur, they would just be delayed by 18 months. Thus, broiler growers would experience unquantifiable costs (foregone benefits) proportional to this delay, though AMS expects these unquantifiable costs to be small.

AMS also evaluated benefits and costs of delaying the effective date for 12 months (12-Month Delay Alternative). The 12-Month Delay Alternative is similar to the proposed alternative, but the effective date of the Payment Systems rule would be delayed 12 rather than 18 months. Under the 12-Month Delay Alternative all costs for both LPDs and growers would be shifted back by one year, resulting in a savings to LPDs of $4.9 million and poultry growers of $249,000 in administrative costs for a total of $5.2 million in savings. Because administrative costs for LPDs were expected to decrease in the fifth year after the rule became effective, costs in the fifth year would be $800,000 higher for LPDs if the effective date is delayed 12 months. The ten-year total direct administrative cost savings would be $4.3 million for the 12-Month Delay Alternative. The table below contains estimated administrative cost savings for LPDs and poultry growers for the 12-Month delay Alternative.

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2026-2712; Project Identifier AD-2025-00931-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Emanuel Chaves Torres, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 562-627-5350; email: emanuel.chaves.torres@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2019-20-07, Amendment 39-19760 (84 FR 54765, October 11, 2019) (AD 2019-20-07), for all The Boeing Company Model 787-8, 787-9, and 787-10 airplanes. AD 2019-20-07 was prompted by a determination that the LE OB slat system could be out of position without flight deck annunciation. AD 2019-20-07 requires repetitive operational checks of the LE OB slats and applicable on-condition actions. AD 2019-20-07 also requires revising the AFM to prohibit flap retraction under icing conditions and revising the existing maintenance or inspection program, as applicable, to incorporate a new operation check. The agency issued AD 2019-20-07 to address a potential condition in which the LE OB slat system could be out of position without flight deck annunciation. This condition, if not addressed, could result in insufficient lift, resulting in inability to maintain continued safe flight and landing.

The preamble to AD 2019-20-07 specifies that the FAA considers that AD “interim action” and that the FAA may consider further rulemaking. Since the FAA issued AD 2019-20-07, the manufacturer has developed final actions to address the unsafe condition. The FAA has determined that these final actions must be required to address the unsafe condition and that accomplishing the final actions will terminate the requirements of AD 2019-20-07. The manufacturer has also incorporated these final actions on airplanes in production, which reduces the number of airplanes that would be affected by the unsafe condition.

The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-SB270055-00 RB, Issue 002, dated November 25, 2024. This material specifies procedures for replacing the LE outboard GRA with a LEOLA at leading edge slat 2 and slat 11 outboard locations and revising the operator's maintenance program to incorporate CMR document item 27-CMR-14, “Functionally check the Leading Edge Power Drive Unit Half System Torque Brake.”

This proposed AD would also require Boeing Alert Requirements Bulletin B787-81205-SB270051-00 RB, Issue 001, dated July 5, 2019, which the Director of the Federal Register approved for incorporation by reference as of October 11, 2019 (84 FR 54765, October 11, 2019).

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

This proposed AD would retain all requirements of AD 2019-20-07. This proposed AD would remove airplanes from the applicability by specifying affected line numbers and require new actions that would terminate the requirements of AD 2019-20-07. This proposed AD would also require accomplishing the actions specified in the material already described, except for any differences identified as exceptions in the regulatory text of this proposed AD.

For information on the procedures and compliance times, see this material at regulations.gov under Docket No. FAA-2026-2712.

The FAA estimates that this AD, if adopted as proposed, would affect 174 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the agency estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

FDA (Agency or we) is proposing to classify blood irradiator devices, which are unclassified, preamendments devices, into two classes based on intended use. FDA proposes to classify blood irradiator devices intended to irradiate blood and blood products to prevent transfusion-associated graft-versus-host disease (blood irradiators intended to prevent TA-GVHD), including those intended to inactivate leukocytes and/or lymphocytes to prevent TA-GVHD, into class II (special controls). Under this proposed rule, blood irradiators intended to prevent TA-GVHD would be subject to premarket notification to provide a reasonable assurance of safety and effectiveness of these devices. FDA proposes to classify blood irradiator devices intended to irradiate intraoperatively salvaged blood of cancer patients undergoing surgery to prevent metastasis (blood irradiators intended to prevent metastasis) into class III (premarket approval). A blood irradiator is a prescription device used to deliver a controlled radiation dose to blood or blood products. Blood and blood products in containers, such as blood bags, are placed inside a canister(s) that is loaded into the exposure chamber for irradiation. The radiation dose from blood irradiators intended to prevent TA-GVHD is intended to inactivate viable leukocytes, including lymphocytes, prior to transfusion to prevent TA-GVHD. While TA-GVHD is a rare complication of transfusion, in patients who develop TA-GVHD, it is fatal in the majority of affected patients. The radiation dose from blood irradiators intended to prevent metastasis is intended to result in damage of tumor cells. Blood irradiators within the scope of this proposed rule include an x-ray tube or a radionuclide sealed radiation source ( e.g., Cobalt-60 or Cesium-137). FDA currently regulates these unclassified devices as devices that require premarket notification (510(k)), with product code MOT. 1 FDA intends to create a separate product code for blood irradiators intended to prevent metastasis upon finalization of this classification action. 2

FDA initiated the classification of blood irradiators by consulting the Radiological Devices Advisory Panel at a meeting held on April 12, 2012 (2012 Panel) (Ref. 1). The 2012 Panel recommended that blood irradiators intended to prevent TA-GVHD be classified into class II, because the 2012 Panel believed that general and special controls would provide reasonable assurance of the safety and effectiveness of these devices. The materials considered by the 2012 Panel noted that one device had been cleared at the time for the prevention of metastasis, but the 2012 Panel did not issue a recommendation as to the classification of blood irradiators intended to prevent metastasis.

FDA initiated the classification of blood irradiators intended to prevent metastasis by consulting the Radiological Devices Advisory Panel at a meeting held on November 7, 2023 (2023 Panel) (Ref. 2). The 2023 Panel recommended that blood irradiators intended to prevent metastasis be classified into class III. The 2023 Panel consensus was that insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of safety and effectiveness of these devices, and blood irradiators intended to prevent metastasis present a potential unreasonable risk of illness or injury.

FDA conducted its own analyses of information from the 2012 and 2023 Panels (Refs. 1 and 2), including risks identified in the Center for Biologics Evaluation and Research (CBER) July 1993 memorandum “Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products” (CBER Memorandum) (Ref. 3); postmarket data regarding blood irradiators with product code MOT; adverse event reports in FDA's Manufacturer and User Facility Device Experience (MAUDE) database and Medical Device Report (MDR) database; information in CDRH's Medical Device Recalls database, and published scientific literature, as further described below. Based upon the analyses, FDA agrees with the recommendations of the 2012 Panel and the 2023 Panel. As such, FDA is proposing a split classification for blood irradiators.

FDA is proposing to classify blood irradiators intended to prevent TA-GVHD, including those intended to inactivate leukocytes and/or lymphocytes to prevent TA-GVHD, into class II (special controls). FDA is proposing this action based on the determination that general controls alone are not sufficient to provide reasonable assurance of the safety and effectiveness of blood irradiators intended to prevent TA-GVHD, and there is sufficient information to establish special controls, in combination with general controls, to provide such assurance. Under this proposal, premarket notification for blood irradiators intended to prevent TA-GVHD would be required.

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  3 while continuing to provide a reasonable assurance of device safety and effectiveness. 4 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 modification described in the PCCP.

FDA is proposing to classify blood irradiators intended to prevent metastasis into class III (premarket approval). FDA is proposing this classification as FDA believes that insufficient information exists to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis, and that these devices present a potential unreasonable risk of illness or injury. FDA is also proposing, by proposed order published elsewhere in this issue of the Federal Register , to require the filing of a premarket approval application (PMA) for blood irradiators intended to prevent metastasis.

This rule proposes to classify unclassified, preamendments blood irradiators: blood irradiators intended to prevent TA-GVHD, including those intended to inactivate leukocytes and/or lymphocytes to prevent TA-GVHD, and blood irradiators intended to prevent metastasis. The proposed rule, if finalized, would establish the identification and classification for these blood irradiator devices. The proposed classification action proposes to classify blood irradiators intended to prevent TA-GVHD into class II as well as establish the special controls necessary to provide reasonable assurance of the safety and effectiveness of these devices. Under this proposed rule, premarket notification would be required for blood irradiators intended to prevent TA-GVHD. The proposed classification action proposes to classify blood irradiators intended to prevent metastasis into class III and require filing of a PMA. These proposed classification regulations, if finalized, would identify these blood irradiator devices as intended for prescription use.

The Agency is proposing this classification under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq. ). Specifically, the relevant authority related to the proposed classification includes section 513(a) through (d) of the FD&C Act (21 U.S.C. 360c(a) through (d)), regarding device classes, classification, and panels and section 515 (21 U.S.C. 360e) regarding PMAs; and section 701(a) of the FD&C Act (21 U.S.C. 371(a)).

The proposed rule, if finalized, would classify blood irradiators (unclassified, preamendments devices) into two classes based on intended use. It would classify blood irradiators intended to prevent TA-GVHD into class II (special controls) and blood irradiators intended to prevent metastasis into class III (premarket approval). Separately, FDA also is issuing a proposed order requiring the filing of a PMA for blood irradiators intended to prevent metastasis. Quantified benefits of the proposed rule, if finalized, would consist of cost savings to industry and FDA from a reduction in the quantity and time burden of informal inquiries related to blood irradiators intended to prevent TA-GVHD. We also estimate cost savings to industry and FDA from a reduction in the number of 510(k) submissions necessitating requests for additional information from FDA before and during review. Industry and FDA could incur costs associated with premarket approval applications for current and future blood irradiators intended to prevent metastasis. We additionally quantify one-time costs to industry to read and understand the proposed rule and the proposed order requiring the filing of a PMA, as well as one-time costs to industry to revise labeling. We estimate that the annualized benefits over 10 years would range from $84 to $180,268 at a 7 percent discount rate, with a primary estimate of $90,176, and from $86 to $184,271 at a 3 percent discount rate, with a primary estimate of $92,178. The annualized costs would range from $0.68 million to $1.51 million at a 7 percent discount rate, with a primary estimate of $1.07 million, and from $0.66 million to $1.53 million at a 3 percent discount rate, with a primary estimate of $1.07 million.

After the enactment of the 1976 Medical Device Amendments, FDA undertook an effort to identify and classify all preamendments devices in accordance with section 513(d) of the FD&C Act (21 U.S.C. 360c(d)). Section 513(b) of the FD&C Act (21 U.S.C. 360c(b)) requires FDA to classify all preamendments devices into class I, II, or III. Currently, blood irradiators, product code MOT, are unclassified devices subject to premarket notification (510(k)) under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Marketing of a new device within an unclassified device type requires FDA clearance of a 510(k). As described below, available records indicate FDA granted the first clearance of a blood irradiator intended to prevent TA-GVHD (K837346) in 1983 based on documentation that demonstrated that these devices are substantially equivalent to device(s) of the same type that were in commercial distribution prior to passage of the Medical Device Amendments on May 28, 1976. On May 26, 2005, FDA cleared the Raycell X-ray Blood Irradiator device (K051065). The Raycell X-ray Blood Irradiator is the first device to include, in addition to an intended use for the prevention of TA-GVHD, a second intended use for the prevention of metastasis. 5 To date, FDA has cleared a total of 16 devices under product code MOT. Two of the devices are cleared with dual intended uses to prevent TA-GVHD and to prevent metastasis.

FDA agrees with the 2012 Panel that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of blood irradiators intended to prevent TA-GVHD, and sufficient information exists to establish special controls to adequately mitigate the risks to health and provide reasonable assurance of safety and effectiveness of this device. FDA is proposing to classify blood irradiators intended to prevent TA-GVHD into class II. FDA agrees with the 2023 Panel that insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis, and that the device presents a potential unreasonable risk of illness or injury. FDA is proposing to classify blood irradiators intended to prevent metastasis into class III.

The FD&C Act (21 U.S.C. 301 et seq. ), as amended by the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness: class I (general controls), class II (special controls), and class III (premarket approval).

Section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)) defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 of the FD&C Act (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act.

Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).

Class III devices are those devices for which insufficient information exists to determine that general controls (controls authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 of the FD&C Act or any combination of such sections) and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act.

FDA refers to devices that were in commercial distribution before the 1976 amendments as “preamendments devices.” The procedures for classification of such devices are prescribed in sections 513(b)-(d) of the FD&C Act (21 U.S.C. 360c(b)-(d)). FDA classifies these devices after the Agency has: (1) received a recommendation from the appropriate device classification panel (which are part of the FDA Medical Devices Advisory Committee); (2) published the panel's recommendation and a proposed regulation classifying the device for comment; and (3) published a final regulation classifying the device (section 513(d)(1) of the FD&C Act. FDA has classified most preamendments devices under these procedures.

A preamendments device that has been classified into class III only requires premarket notification and not approval of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. FDA is also proposing, by proposed order published elsewhere in this issue of the Federal Register , to require the filing of a PMA for blood irradiators intended to prevent metastasis.

Blood irradiators that include an x-ray source are radiation-emitting electronic products and, accordingly, also are subject to the Electronic Product Radiation Control requirements of the FD&C Act (sections 531 through 542 (21 U.S.C. 360hh through 360ss)) (originally enacted as the Radiation Control for Health and Safety Act of 1968), and its implementing regulations. This includes compliance with certain performance standards found in 21 CFR 1020.40 for cabinet x-ray systems, pursuant to the authority found in section 534 of the FD&C Act (21 U.S.C. 360kk). A blood irradiator that includes an x-ray source meets the definition of a cabinet x-ray system found in 21 CFR 1020.40(b)(3) because it consists of an x-ray tube installed in an enclosure intended to contain at least that portion of material, in this case blood or blood components, being irradiated, provides radiation attenuation, and excludes personnel from its interior during generation of x radiation.

Blood irradiators that include a radionuclide sealed radiation source (sealed radiation source) may be subject to regulatory requirements of the Nuclear Regulatory Commission (NRC) pursuant to its authority under the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq. ).

As previously described, blood irradiator devices are unclassified, preamendments devices. These devices have been subject to premarket review through a 510(k) submission and have been cleared for marketing if FDA found the device to be substantially equivalent to a legally marketed predicate in accordance with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)). FDA has cleared a total of 16 devices within the scope of this classification action. Consistent with the FD&C Act, FDA convened the Radiological Devices Advisory Panel at two meetings regarding the classification of blood irradiators.

On April 12, 2012, FDA convened the 2012 Panel to secure recommendations regarding risks and benefits presented by blood irradiators as well as the appropriate classification and regulatory controls that should apply to this device type (Ref. 1). At the meeting, FDA requested that the 2012 Panel consider whether blood irradiators intended to prevent TA-GVHD fit the statutory definition for a class II device. The 2012 Panel considered the information about this device type provided by FDA, including results and analysis from a literature search and search of known adverse events (Ref. 1). The 2012 Panel considered both types of blood irradiators intended to prevent TA-GVHD: the x-ray tube blood irradiators and the sealed radiation source blood irradiators. The 2012 Panel did not issue a recommendation as to the classification of blood irradiators intended to prevent metastasis.

At the 2012 Panel meeting, FDA presented information on the identified risks to health and proposed mitigation measures for blood irradiators intended to prevent TA-GVHD. FDA-identified risks to health included improper radiation dose to blood or blood products, radiation exposure to the user, and electric shock. FDA proposed mitigation measures for the identified risks to health, which included premarket review of indications for use and design specifications, and compliance with the CBER Memorandum (Ref. 3). The CBER Memorandum provides recommendations to blood establishments on manufacturing, quality control procedures, labeling and other aspects of manufacturing irradiated blood and blood products. FDA also suggested in 2012 Panel materials, as a mitigation for certain risks to health, compliance with NRC regulations and certain regulations of states that have entered into agreements with NRC that govern radioactive isotopes and their safe use (collectively referred to in the remainder of this proposed rule as “NRC regulations”), which would apply to blood irradiators that use a sealed radiation source. During the 2012 Panel meeting, FDA presented the additional risk of damage to blood or blood components from radiation. This risk is associated with a shorter shelf life for irradiated blood and blood components, as noted in the CBER Memorandum and discussed at the 2012 Panel.

The 2012 Panel agreed with the FDA-identified risks to health associated with blood irradiators intended to prevent TA-GVHD. Several of the 2012 Panel members suggested additional risks of mechanical or crush injury from door closure and dose inhomogeneity. For dose inhomogeneity, multiple Panel members expressed a concern that a large dose inhomogeneity could result in the blood or blood product receiving an ineffective dose of radiation. The main concern was the ability to deliver 25 gray (Gy) of radiation targeted to the central portion of the container and to achieve a 15 Gy minimum dose at any other point within the container, as recommended in the CBER Memorandum, for all contents in the irradiation exposure chamber for all possible fillings. Several of the 2012 Panel members also expressed concern for safety and security in terms of using the device and adequate training of personnel. FDA has interpreted concerns about safety and security to be about operator error and lack of safety controls on the device to protect against exposure to the radiation source. There was some disagreement among the 2012 Panel members as to whether manufacturer-provided personnel training should be a special control because of the challenge it puts on manufacturers and on facilities' ability to perform their own training.

The 2012 Panel members suggested that the risks to health associated with improper radiation dose, including not achieving minimum dosing throughout the irradiated blood and blood components due to dose inhomogeneity, could be mitigated by performance standards and design controls (Ref. 1, 2012 Panel transcript at 187-189). FDA interprets this discussion to mean performance testing to demonstrate that the device performs as intended under anticipated conditions of use, and certain labeling information. For dose inhomogeneity, the 2012 Panel members also recommended periodic demonstration of the dose uniformity and a recommended dosimetric evaluation interval. Based upon the 2012 Panel discussion, FDA interprets periodic demonstration of the dose uniformity at recommended intervals to mean the inclusion of a recommended quality assurance program by the manufacturer, that manufacturers provide information about dosimetric distribution measured both in air and with the canister or exposure chamber filled with water, and that manufacturers provide information about decay and residual strength of the sealed radiation source, where applicable. The 2012 Panel also suggested some indication of dose rate and a manufacturer provided method for identifying if the proper dose of radiation is delivered. To mitigate against the risk of exposure to the sealed radiation source, which may be caused by operator error or lack of safety controls on the device, the 2012 Panel suggested adding a special control requiring safety and security that limits who can operate the device. Some of the 2012 Panel-recommended mitigations were suggested by the CBER Memorandum.

The consensus of the 2012 Panel was that class I (general controls) alone would not be adequate to provide a reasonable assurance of safety and effectiveness for blood irradiators intended to prevent TA-GVHD and that special controls could be identified. The 2012 Panel agreed that the CBER Memorandum, although intended for blood establishments manufacturing irradiated blood products, provided a good resource to develop special controls for both sealed radiation source and x-ray source devices. The 2012 Panel noted that blood irradiators are an established technology to prevent TA-GVHD in transfused patients, and that blood establishments' implementation of the recommendations in the CBER Memorandum, together with the performance standards found in 21 CFR 1020.40 for cabinet x-ray systems, which would include x-ray source blood irradiators, had resulted in few published problems and no reported adverse events in literature over a long period of time when the device was used at the CBER recommended dosage level. The 2012 Panel recommended that blood irradiators intended to prevent TA-GVHD be classified into class II to provide reasonable assurance of safety and effectiveness of these devices.

FDA tentatively agrees with the 2012 Panel's recommendation that general controls and special controls are needed to provide reasonable assurance of safety and effectiveness of blood irradiators intended to prevent TA-GVHD and that this device be classified into class II. General controls are insufficient to provide reasonable assurance of safety and effectiveness of this device type based on the fatal nature of TA-GVHD and risk of the disease if the radiation exposure does not inactivate the lymphocytes present in the blood. Identification of the dose of radiation necessary to inactivate lymphocytes, pre-market data requirements showing that the blood irradiator is capable of delivering this radiation dose to the blood and blood components, and labeling requirements including required quality control processes are necessary to mitigate the identified risks to health. Accordingly, FDA is proposing to classify blood irradiators intended to prevent TA-GVHD into class II (special controls).

On November 7, 2023, FDA convened the 2023 Panel to make recommendations regarding the risks and benefits presented by blood irradiators intended to prevent metastasis as well as the appropriate classification and regulatory controls that should apply to these devices (Ref. 2). At the meeting, FDA requested that the 2023 Panel consider whether blood irradiators intended to prevent metastasis fit the statutory definition for a class III device. The 2023 Panel considered the information provided by FDA about blood irradiators intended to prevent metastasis, including results and analysis from a literature search and search of known adverse events (Ref. 2).

During the 2023 Panel meeting, FDA presented information on the identified risks to health for blood irradiators intended to prevent metastasis as well as proposed mitigation measures. FDA identified similar risks to health related to the device hardware and software as blood irradiators intended to prevent TA-GVHD, which are similar in design and function. Specifically, these risks to health included: damage to blood components from radiation, unintended (non-therapeutic) radiation exposure to the operator and public, electric shock or burn, and mechanical or crush injury. FDA also identified unique risks to health posed by the intended use of blood irradiators intended to prevent metastasis, including presence of proliferative malignant cells in re-transfused blood due to incorrect dose or improper dose of radiation delivered, worsened control of oncologic disease or patient prognosis, and delayed or lack of re-transfusion of irradiated blood or blood component.

FDA's search of literature for blood irradiators intended to prevent metastasis for the 2023 Panel returned a limited number of articles (Ref. 2, FDA Executive Summary, Appendix D). None of the articles identified as part of the systematic literature search provided information on the safety assessment of the use of these devices for prevention of metastasis. No articles provided definitive information on the effect of salvaged blood irradiation on metastasis. Moreover, the literature showed a lack of consensus on the specific dose to use (reported doses were 25-50 Gy) to render tumor cells nonviable, and for which cancer type and surgical procedure (Ref. 2, Presentation (Classification of Blood Irradiators for the Prevention of Metastasis)). Several articles observed that blood irradiation took additional time to perform (Ref. 2, Presentation (Classification of Blood Irradiators for the Prevention of Metastasis)). At the meeting, FDA indicated that because long-term safety risks, such as the cancer outcome, patient recovery, or survival, are unclear based upon the available information, these risks to health may not be effectively mitigated by special controls. Further, based on the available information, there appears to be a lack of clinical data to demonstrate a clear clinical benefit from use of the blood irradiators intended to prevent metastasis.

The 2023 Panel agreed with the FDA-identified risks to health for blood irradiators intended to prevent metastasis. The 2023 Panel identified several additional risks to health related to the device's intended use, including: risk of induction of a new cancer due to irradiation of the blood or blood components, risk of induction of mutations in cells irradiated more than once ( i.e., if blood was salvaged and re-transfused multiple times during the surgical procedure), risks associated with the volume of blood that may need to be irradiated and the additional operating procedure time, and risks associated with usability including irradiating the salvaged blood outside the operating room and the potential for blood to be incorrectly labeled or misidentified. The 2023 Panel also noted that it is unclear whether risks to health related to the device's intended use can be exhaustively identified.

The 2023 Panel consensus was that insufficient information exists to determine that class I (general controls) and class II (special controls) are sufficient to provide reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis. The 2023 Panel members suggested that risks to health associated with the device's hardware and software were similar to those for blood irradiators intended to prevent TA-GVHD because device function and design were the same. However, the risks to health associated with the device's intended use—for the prevention of metastasis in cancer patients receiving intraoperatively salvaged blood—could not fully be identified or mitigated with general and special controls given the very limited data available. In addition, there are uncertainties about the effective radiation dose, including whether the dose would be the same for all cancer types and all surgical procedures. Regarding the benefit and risk assessment, the 2023 Panel consensus was there is no definitive evidence showing that irradiation of intraoperatively salvaged blood is effective to prevent metastasis in patients. As a result, the risk of injury is unreasonable given the lack of probable benefit. The 2023 Panel recommended that these devices be classified into class III (premarket approval).

FDA agrees with the 2023 Panel that risks to health of blood irradiators for the prevention of metastasis cannot fully be identified or mitigated with special controls given the very limited data available and that there is a potential unreasonable risk of illness or injury for these devices given the lack of probable benefit. For the reasons stated by the 2023 Panel, FDA has tentatively determined that general controls and special controls are not sufficient to provide reasonable assurance of safety and effectiveness of blood irradiators intended to prevent metastasis. FDA is proposing that these devices be classified into class III.

The Agency is proposing this classification under the authority of the FD&C Act (21 U.S.C. 301 et seq. ). Specifically, the relevant authority related to the proposed classification includes sections 513(a) through (d) of the FD&C Act (21 U.S.C. 360c(a) through (d)), regarding device classes, classification, and panels; and section 515 (21 U.S.C. 360e), regarding PMAs.

We are proposing to amend subpart G of 21 CFR part 892 by adding §  892.7000 to classify blood irradiators, currently categorized under the product code MOT, with sub-sections for blood irradiators intended to prevent TA-GVHD, including those intended to inactivate leukocytes and/or lymphocytes to prevent TA-GVHD, and blood irradiators intended to prevent metastasis, in accordance with section 513(d) of the FD&C Act (21 U.S.C. 360c(d)) and section 701(a) of the FD&C Act (21 U.S.C. 371).

A blood irradiator is a prescription device used to deliver a controlled radiation dose to blood or blood products. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met. This generic type of device may include an x-ray or a sealed radiation source. Blood irradiators intended to prevent TA-GVHD are used to deliver a controlled radiation dose to blood or blood products prior to transfusion to prevent TA-GVHD. Blood irradiators intended to prevent metastasis are used to irradiate intraoperatively salvaged blood ex vivo for cancer patients undergoing surgery to assist in the prevention of metastasis.

In evaluating the risks to health associated with use of blood irradiators intended to prevent TA-GVHD and blood irradiators intended to prevent metastasis, FDA considered information from the 2012 Panel and 2023 Panel, respectively, including risks identified in the CBER Memorandum (Ref. 3); postmarket data regarding blood irradiators with product code MOT, including adverse event reports in the MAUDE database; CDRH's Medical Device Recalls database, and the published scientific literature, some of which is discussed in FDA's executive summaries for the 2012 and 2023 Panel meetings (Refs. 1 and 2).

For blood irradiators intended to prevent TA-GVHD, in addition to the literature analysis conducted for the 2012 Panel meeting, FDA conducted literature searches on January 25, 2024, and September 23, 2024, for articles published since the 2012 Panel meeting about these devices. These literature searches identified nine additional relevant articles (Refs. 4-12). The information from the contemporary literature analyses is consistent with the findings of the prior literature analysis presented at the 2012 Panel meeting. For blood irradiators intended to prevent metastasis, in addition to the literature analysis conducted for the 2023 Panel meeting, FDA conducted a contemporary literature search on September 23, 2024, for articles published since the prior search for the 2023 Panel meeting. One new paper was identified (Ref. 13). The information from the 2024 literature analysis is consistent with the findings of the prior literature analysis presented at the 2023 Panel meeting.

FDA's search of the MAUDE and MDR databases for the 2012 and 2023 Panel meetings for product code MOT, which includes blood irradiators intended to prevent TA-GVHD and blood irradiators intended to prevent metastasis, identified five MDRs related to blood irradiators reported in MAUDE. Two MDRs contained no information, one was a suggestion for devices to include an audible alarm, and two noted low x-ray tube output that may have resulted in less than 15 Gy being delivered to all locations within the irradiation canister. No direct adverse events to patients were reported. Following these searches, FDA received one additional report describing multiple adverse events on May 14, 2024. The adverse events were related to high current safety interlock system switch failures that were reported to result in superficial (first-degree) burns. For blood irradiators intended to prevent TA-GVHD, the proposed special controls covering demonstration of appropriate functioning of safety systems, including interlocks, and electrical safety testing are designed to mitigate this risk to health. During the same time period, there were no accidental radiation occurrences (AROs) reported under 21 CFR 1002.20 for devices with product code MOT containing x-ray tubes. FDA conducted updated queries for MDRs on July 7, 2025, and for AROs on November 22, 2024 and August 4, 2025. No additional reports were identified.

FDA also reviewed recalls reported under product code MOT from November 2002 to June 22, 2025. There were two product recalls during that time period. The first recall was a class 3 recall to complete a cooling system retrofit to preclude overheating and failure of the device. The recall was terminated May 13, 2012. 6 The second recall was a class 2 recall, for non-compliance with the associated performance standards within 21 CFR Subchapter J Radiological Health. Specifically, the device failed to comply with the performance standard for cabinet x-ray systems (21 CFR 1020.40). 7 To address this issue, the company completed repairs during annual routine preventive maintenance visits at the users' sites to minimize downtime, and the recall was terminated August 1, 2017.

As noted in Section III.C.1, for blood irradiators intended to prevent TA-GVHD, the 2012 Panel members suggested additional risks to health of mechanical crush and injury, dose inhomogeneity, and safety and security in terms of using the device and adequate training of personnel, which FDA has interpreted to be about operator error and a lack of safety controls to protect against exposure to the radiation source. FDA agrees that there is a risk to health of mechanical or crush injury from door closure and has added it as a separate risk category. The design of blood irradiators includes an amount of shielding sufficient to prevent radiation exposure to the operator, causing the door to be atypically heavy. FDA also agrees that dose inhomogeneity may pose a risk that not all blood and blood products placed in the device receive an effective dose of radiation. However, FDA does not believe that dose inhomogeneity needs to be added as a separate category of risk to health. Instead, FDA included this risk to health within the description of the risk of improper radiation to blood or blood products, with mitigations included in the proposed special controls to address this concern. FDA included risks to health posed by operator error and a lack of safety controls on the device within “Improper radiation dose to blood or blood products” and “Unintended radiation exposure to the operator and others,” respectively. Safety controls include device access controls that may be hardware or software controlled. FDA modified the risk category from “Radiation exposure to the user” to “Unintended radiation exposure to the operator and others” to expressly capture risk to other persons in the vicinity of the device in addition to the direct operator and to clarify that the exposure is unintended ( i.e., it is not part of the limited degree of radiation exposure that is anticipated and accepted when using a device that works via ionizing radiation).

Based upon the information described above, FDA identified the following risks to health for blood irradiators intended to prevent TA-GVHD:

• Damage to blood or blood components from radiation: Irradiation of whole blood and red blood cells causes damage to red blood cells and lymphocytes within the blood. Radiation damages the membrane of red blood cells leading to higher concentrations of potassium in plasma, hemolysis (destruction of red blood cells), and decreased red blood cell viability and survival.

• Improper radiation dose to blood or blood products: Failure to deliver a proper radiation dose to the intended target can result in immunologically active cells in transfused blood or blood products, which may result in TA-GVHD, which is often fatal. Delivery of an improper dose could result from multiple causes including: inability of the device to deliver 25 Gy of radiation targeted to the central portion of the container or a 15 Gy minimum dose at any other point within the container; dose inhomogeneity; malfunction of the device; lack of adequate maintenance, dosimetry or quality assurance checks; electrical fault, electromagnetic interference, or mechanical fault; or operator error causing improper dose delivery, including improper loading of the sample canister and incorrect exposure time entered into the user interface.

• Unintended radiation exposure to the operator and others: Device malfunction, lack of adequate maintenance, inadequate shielding, or safety control or interlock failure could allow the operator to access the radiation source resulting in physical injury and/or exposure of the operator or other nearby persons to radiation. Exposure to ionizing radiation has been shown to increase cancer risk (Ref. 14). Insufficient presence of safety controls or interlocks within irradiator design may result in unintended exposure.

• Electrical shock: Electrical malfunction of the device or operator contact with an energized portion may result in electrical shock or burns. This can occur when there are insufficient or malfunctioning safety controls or interlocks.

• Mechanical crush or injury: Blood irradiators contain shielding materials to prevent excess radiation emission outside the device causing the device itself and many components to be heavy. Operator inattention or placement of body parts where they can be impinged by the device may result in physical injury to the operator.

In evaluating benefits associated with the use of blood irradiators intended to prevent TA-GVHD, FDA considered information from the 2012 Panel regarding the classification of blood irradiators intended to prevent TA-GVHD and the published scientific literature. The information indicated that blood irradiation is an accepted method to prevent TA-GVHD by inactivation of T-lymphocytes to prevent post-transfusional proliferation and has been widely used for this purpose since the 1970s (Ref. 1, Executive Summary, Appendix A, Section III.A).

As noted in Section III.C.2, in addition to the risks to health that FDA presented at the 2023 Panel for blood irradiators intended to prevent metastasis, Panel members suggested additional risks to health: risk of induction of a new cancer due to irradiation of the blood or blood components, risk of induction of mutations in cells irradiated more than once ( i.e., if blood was salvaged and re-transfused multiple times during the surgical procedure), risks associated with the volume of blood that may need to be irradiated and the additional operating procedure time, and risks associated with usability including irradiating the salvaged blood outside the operating room and the potential for blood to be incorrectly labeled or misidentified. FDA agrees with the additional risks to health identified by the 2023 Panel. However, FDA does not believe that induction of mutations in cells irradiated more than once needs to be added as a separate category of risk to health. FDA views this risk as a subset of the risk of induction of a new cancer due to the irradiation of the blood or blood components. Multiple irradiations may lead to a greater chance of a cell being damaged. Should this damage result in negative changes in the cell, the risk to the patient would be induction of a new cancer if cells are malignantly transformed. Accordingly, we have included the risk of induction of mutations in cells within the description of the risk “Induction of a new cancer due to irradiation of the blood or blood components.”

We have included the risk associated with the volume of blood that may need to be irradiated with the description of the risk to health “Delayed or lack of re-transfusion of irradiated blood or blood components.” Irradiation of the blood adds time to the intraoperative procedure, after salvage and filtration have occurred. Depending how much blood is removed for re-transfusion and when it is re-transfused during the procedure, irradiation may need to occur multiple times. In addition, FDA has updated the wording of the risk to health “Damage to blood components from radiation” to “Damage to blood or blood components from radiation” to better reflect the variety in the product re-transfused ( e.g., blood with plasma proteins and clotting factors, washed red blood cells). The term blood component was originally used to specify that it was a blood component ( i.e., lymphocyte or red blood cell) that was damaged by irradiation. FDA also updated the wording of the risk to health “Unintended radiation exposure to the operator and public” to “Unintended radiation exposure to the operator and others” to clearly reflect other persons who may be at risk of such exposure ( e.g., patients, bystanders).

Based on the information described in this Section V.B., FDA has identified the following risks to health associated with blood irradiators intended to prevent metastasis:

• Damage to blood or blood components from radiation: Irradiation of whole blood and red blood cells causes damage to red blood cells and lymphocytes within the blood. Radiation damages the membrane of red blood cells leading to higher concentrations of potassium in plasma, hemolysis (destruction of red blood cells), and decreased red blood cell viability and survival.

• Unintended radiation exposure to the operator and others: Device malfunction, lack of adequate maintenance, inadequate shielding, or safety control or interlock failure could allow the operator to access the radiation source resulting in physical injury and/or exposure of the operator or other nearby persons to radiation. Exposure to ionizing radiation has been shown to increase cancer risk (Ref. 13). Insufficient presence of safety controls or interlocks within irradiator design may result in unintended exposure.

• Electrical shock:   8 Electrical malfunction of the device or operator contact with an energized portion may result in electrical shock or burn. This can occur when there are insufficient or malfunctioning safety controls or interlocks.

• Mechanical or crush injury: Blood irradiators contain shielding materials to prevent excess radiation emission outside the device causing the device itself and many components to be heavy. Operator inattention or placement of body parts where they can be impinged by the device may result in physical injury to the operator.

• Presence of proliferative malignant cells in re-transfused blood due to incorrect dose or improper dose of radiation delivered: Incorrect dose of radiation identified to be effective or improper dose of radiation delivered due to operator error, device malfunction, lack of adequate maintenance, or lack of dosimetry or quality assurance checks, may result in tumor cell survival leaving proliferative ( i.e., able to function, grow, and divide) tumor cells present in the blood.

• Worsened control of oncologic disease or patient prognosis: Irradiating blood or blood components may cause an immune response that negatively impacts cancer outcome or patient recovery or survival.

• Delayed or lack of re-transfusion of irradiated blood or blood components: Use of the device inherently delays re-transfusion and lengthens the duration of the operating procedure with larger volumes of blood irradiated adding a larger amount of additional operating procedure time. Device malfunction, including from mechanical, electrical, or software malfunctions, or operator error could lead to improper or no irradiation of the blood or blood components, which could add additional delay if the malfunction or error results in the salvaged blood not being suitable for re-transfusion into the patient. Delay in re-transfusion could increase risk to patients depending on their blood volume at any given point in the procedure. Longer operating times are associated with increased risks, including prolonged exposure to anesthesia and greater risk of infection.

• Induction of a new cancer due to irradiation of the blood or blood components: Irradiation of nucleated cells may result in malignant transformation as ionizing radiation exposure causes DNA damage that may result in downstream biologic effects ( e.g., mutation, cell killing or carcinogenesis) (Ref. 15). Permanent DNA damage could result in the cells becoming malignant. Quantitative risk assessment of this phenomenon occurring in irradiated blood for the prevention of metastasis has not been performed. If blood salvage and processing, including irradiation, occurs multiple times, blood cells may be exposed to ionizing radiation multiple times. If those cells are returned into the body this could result in induction of a new cancer.

• Risks associated with usability including irradiating the salvaged blood outside the operating room and the potential for blood to be incorrectly labeled or misidentified: Included in this risk to health are issues with operating the device in a way that results in an incorrect blood product being given to the patient. For example, should blood irradiation be performed in a manner where blood or blood products from multiple patients are irradiated at one time, if the bags are labeled with the wrong patient information, or are thought to be irradiated, but are not, this could result in the patient receiving a transfusion of the wrong blood. This could include operator error or inadequate usability testing of the points of interaction between the device and the operator, including displays and instructions for use.

In evaluating benefits associated with the use of blood irradiators intended to prevent metastasis, FDA considered information from the 2023 Panel regarding the classification of blood irradiators intended to prevent metastasis and the results of published scientific literature searches performed on April 20, 2023 and September 23, 2024. The information indicated that there appears to be a lack of clinical data to demonstrate that irradiating intraoperatively salvaged blood is able to prevent metastasis in patients and therefore there is no clear clinical benefit from use of the blood irradiators intended to prevent metastasis.

Based on FDA's experience with blood irradiators intended to prevent TA-GVHD, including those intended to inactivate leukocytes and/or lymphocytes to prevent TA-GVHD, the 2012 Panel's recommendations, and other available information, FDA is proposing to classify blood irradiators intended to prevent TA-GVHD into class II. FDA is proposing to classify blood irradiators intended to prevent TA-GVHD into class II because general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of these devices (see Section III.C.1) as presented and discussed during the 2012 Panel meeting (Ref. 1). FDA also believes there is sufficient information to establish special controls to mitigate the risks to health of the device. FDA has tentatively determined that the special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of blood irradiators intended to prevent TA-GVHD. Blood irradiators intended to prevent TA-GVHD would be subject to 510(k) requirements under section 510(k) of the FD&C Act (21 U.S.C. 360(k)).

Based on FDA's experience with blood irradiators intended to prevent metastasis, the 2023 Panel's recommendations, and other available information, FDA is proposing to classify blood irradiators intended for use in irradiating intraoperatively salvaged blood of cancer patients undergoing surgery to prevent metastasis into class III. FDA is proposing this classification because FDA believes that insufficient information exists to determine that general controls and special controls would provide reasonable assurance of safety and effectiveness for these devices and, based upon assessment of benefits and risks, blood irradiators intended to prevent metastasis present a potential unreasonable risk of illness or injury. FDA does not believe the special controls proposed for blood irradiators intended to prevent TA-GVHD are sufficient to provide reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis. FDA has identified additional risks to health posed by the intended use for prevention of metastasis, as described in section V.B.2, for which it does not have adequate information to establish special controls. Additionally, FDA agrees with the 2023 Panel that the identified risks for this intended use may not be exhaustive. Elsewhere in this issue of the Federal Register , FDA is proposing through a proposed order to require the filing of a PMA under section 515(b) of the FD&C Act. The proposed order will only be finalized if and when FDA finalizes this proposed rule classifying blood irradiators intended to prevent metastasis in class III.

FDA is proposing the special controls identified in this section for blood irradiators intended to prevent TA-GVHD. FDA believes that these special controls, in addition to general controls, are necessary to provide a reasonable assurance of safety and effectiveness of these devices. Special controls for blood irradiators intended to prevent TA-GVHD were discussed at the 2012 Panel (Ref. 1, Executive Summary Table III). The consensus of the 2012 Panel was that the CBER Memorandum was a good resource for establishing special controls for these devices, including blood irradiators for TA-GVHD that use an x-ray source. The 2012 Panel concurred that the recommendations described in the CBER Memorandum provided sufficient guidance for a reasonable assurance of safety and effectiveness for this device type with some additional risk mitigations suggested by the 2012 Panel (Ref. 1, Transcript at 196).

The proposed special controls listed below for blood irradiators intended to prevent TA-GVHD include some risk mitigations and special controls proposed and recommended at the 2012 Panel meeting. FDA agrees with the 2012 Panel that certain recommendations suggested by the CBER Memorandum would support reasonable assurance of safety and effectiveness of blood irradiators to prevent TA-GVHD. As a result, the proposed risk mitigations and special controls for blood irradiators intended to prevent TA-GVHD include controls that are recommended in the CBER Memorandum for blood banks that FDA has determined are appropriate for and adaptable to devices to mitigate the identified risks. The proposed special controls include items suggested by the CBER Memorandum that were specifically discussed by the 2012 Panel members as well as those that were not specifically discussed but that FDA has determined to be relevant to this classification action. The proposed special controls include performance testing; labeling information including a device description, specifying that the device is intended to prevent TA-GVHD, and a warning that elevated levels of potassium have been reported in irradiated blood; software verification, validation, and hazard analysis; and electrical and electromagnetic compatibility testing.

FDA agrees with those 2012 Panel members who suggested a special control to require manufacturer training of operators on device use is not necessary for reasonable assurance of safety and effectiveness for the device. FDA believes that the warnings and detailed procedures and information required by the proposed special controls in the labeling, including clear identification of intended operators, along with adequate warnings, are sufficient, together with other special controls, to mitigate against risks caused by operator error such as improper radiation dose to blood or blood products. FDA also notes 21 CFR 606.20, which among other things requires personnel responsible for the collection, processing, compatibility testing, storage or distribution of blood or blood components to have adequate training and experience, including professional training as necessary, or combination thereof, to assure competent performance of their assigned functions. There have been limited adverse events reported in the MAUDE database, including no reports that were a result of operator error. At this time, FDA believes a special control requiring separate operator safety training given by the manufacturer is unnecessary for reasonable assurance of safety and effectiveness of this device type.

FDA also disagrees with the 2012 Panel suggestion that a special control requiring a minimum dose homogeneity percentage and specification of a particular dose rate to be used when irradiating the blood or blood products is necessary for reasonable assurance of safety and effectiveness. FDA does not believe a minimum dose homogeneity percentage and specification of dose rate ensure that all blood within the container receive a minimum dose of 15 Gy of radiation, nor would they account for mechanisms implemented in device design to address dose inhomogeneity. Instead, to address risks from dose inhomogeneity, FDA is proposing special controls to ensure delivery of at least 25 Gy of radiation targeted to the central portion of the container and a minimum dose of at least 15 Gy at any other point within the container, and performance testing demonstrating conformance with the 25 Gy to the central portion of the container and 15 Gy minimum dose at any other point. FDA does agree with the Panel's suggestion that the manufacturer should provide information on the decay of the source and the residual strength of the source so that dose rate can be assessed. FDA also agrees with the Panel that the manufacturer should provide the dosimetric distribution. This information can be used by the operator to make decisions on how to ensure requirements at individual blood irradiation facilities are met. FDA has included in the proposed special controls labeling controls that include information about the specifications of the device including: dose rate, dosimetric distributions including dose uniformity within each irradiation canister provided with the device, and a detailed procedure for identifying the proper loading configuration of blood and blood products in the canister.

As noted in Section III.C.1, at the 2012 Panel FDA suggested in the 2012 Panel materials compliance with NRC regulations as a mitigation for risks to health from improper radiation dose to blood and blood products, and radiation exposure to the user. We are not including compliance with NRC regulations as a special control in this proposed rule. FDA recognizes that devices containing sealed radiation sources and use of such devices by blood establishments may be subject to NRC regulations and that such regulations may have an effect on the safe use of the device. However, FDA believes that the proposed special controls for blood irradiators intended to prevent TA-GVHD, specifically, non-clinical performance testing demonstrating that the device performs as intended under anticipated conditions of use, which includes documentation demonstrating that safety features, including interlocks, access controls, and shielding perform as intended, labeling, and software verification, validation, together with general controls, are sufficient to provide reasonable assurance of safety and effectiveness of this device type.

Table 1 summarizes how each identified risk to health described in section V.B.1 would be mitigated by the proposed special controls. The mitigation measures in the table have been modified from those presented in Table III of the 2012 Panel Executive Summary during the 2012 Panel meeting (Ref. 1, Executive Summary). The language in Table 1 is more general and identifies the type of mitigation measure ( e.g., labeling) rather than the specific method ( e.g., ensure preventative maintenance program). The mitigation measures have also been modified to include the types of mitigation measures presented and identified at the 2012 Panel meeting ( e.g., compliance with the 1993 CBER Memorandum) with more clarity and specificity regarding the special controls needed to provide reasonable assurance of safety and effectiveness of the device.

Irradiation of blood and blood products to prevent TA-GVHD has been in routine use for decades. TA-GVHD occurs when viable T-lymphocytes in transfused blood or blood products engraft, multiply, and react against the tissues of the recipient. Gamma and x-ray radiation can abrogate the ability of lymphocytes to proliferate in vitro, and studies show that irradiation of at least 15 Gy (gamma irradiation) reduces lymphocyte response to mitogens by 90% (Refs. 3 and 16). The 1993 CBER Memorandum recommended that the dose of radiation delivered to the blood or blood product should be 25 Gy targeted to the central portion of the container and 15 Gy as the minimum dose delivered at any other point. To mitigate the risk of TA-GVHD in patients receiving a transfusion of blood or blood products due to the improper radiation dose being given to the blood or blood products, FDA believes that performance testing is needed to show that the device is capable of delivering the 25 Gy dose targeted to the central portion of the container and minimum 15 Gy dose at any other point within the container. To further mitigate against an improper dose of radiation being delivered to the blood or blood component, either due to operator error or device malfunction, the device function that allows the operator to identify if exposure was prematurely terminated must be validated, and any software functions must undergo software verification, validation, and hazard analysis. To further mitigate this risk, the device labeling must also include information that is needed by the operator to irradiate all contents of the container to the desired dose. This includes:

• A summary of the performance testing conducted that demonstrates that the device can deliver 25 Gy of radiation targeted to the central portion of the container and a minimum of at least 15 Gy of radiation at any other point within the container;

• A detailed procedure that allows the device operator to verify the minimum dose delivered during each use, the dose rate and dose delivered by the device to the container, and if the exposure has been prematurely terminated;

• A detailed procedure identifying the proper loading configuration of the blood or blood component within the canister and exposure chamber and isodose curves for each loading configuration;

• Information about the specifications of the device—the dosimetric distributions within each canister provided with the irradiator measured both in air and loaded with water equivalent material, including dose homogeneity; and

• Instructions for device maintenance.

To mitigate the risk of damage to the blood or blood components from radiation, FDA believes that the labeling must include appropriate warnings and limitations needed for safe use, including statements that irradiation reduces the shelf stability of blood and that elevated potassium levels have been reported in irradiated red blood cell products.

To mitigate the risk of radiation exposure to the operator from the device, FDA believes that documentation is needed to demonstrate that the device performs as intended under anticipated conditions of use, including safety features of the device, which include its interlocks, access controls, and radiation shielding. For any safety features controlled by software, software verification, validation and hazard analysis of the features must be performed to ensure that these features perform as intended under anticipated conditions of use. Finally, to further mitigate this risk, FDA believes that labeling must include an identification of the safety features that enable operators to protect themselves and other nearby persons from unnecessary radiation exposure and the details of their specifications.

To mitigate against electrical shock or burns, FDA believes that adequate performance testing must demonstrate the electrical safety, mechanical safety, thermal safety, and electromagnetic compatibility of any electrical components of the device.

Finally, to mitigate against the risk of mechanical crush injury, FDA believes that labeling must include adequate warnings indicating that improper placement of hands or limbs could result in a mechanical crush injury.

Further, FDA believes that the special controls proposed for blood irradiators intended to prevent TA-GVHD, in addition to the general controls, mitigate the risks to health and are necessary to provide reasonable assurance of safety and effectiveness.

FDA has determined that insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis and that these devices present a potential unreasonable risk of illness or injury based on the limited clinical information that is available. FDA found no evidence that the physical aspects (hardware and software) of blood irradiators intended to prevent metastasis pose a potential unreasonable risk of illness or injury. However, we found no available information about the short- and long-term safety risks presented by the intended use of blood irradiators intended to prevent metastasis, including cancer outcome, patient recovery, or survival. Given the limited reported clinical use of blood irradiators for the irradiation of intraoperative blood salvaged from cancer patients to assist in the prevention of metastasis in the published literature, the list of risks to health currently identified in this proposed classification action may not be exhaustive. For effectiveness, FDA found no definitive available evidence showing that irradiation of intraoperatively salvaged blood is able to prevent metastasis in patients or that it does not trigger an immunological response that could worsen patient prognosis (promote recurrence or invasiveness, or surgical recovery). In addition, the dose of radiation necessary to remove proliferative tumor cells is unclear, and the effects on the blood and blood products are unknown. Given the uncertainty about the extent of risks posed by the device, the lack of evidence supporting effectiveness, and a large amount of uncertainty surrounding the patient benefit from the device, FDA is proposing to classify blood irradiators intended to prevent metastasis into class III.

As required by section 515(b) of the FD&C Act, FDA is publishing elsewhere in this issue of the Federal Register a proposed order to require the filing of a PMA, which will be finalized if this classification action is finalized and these devices for this intended use are classified into class III. The proposed order also contains FDA's proposed findings regarding: the degree of risk of illness or injury designed to be eliminated or reduced by requiring that blood irradiators intended to prevent metastasis have an approved PMA when intended for use that includes delivering a controlled radiation dose to irradiate intraoperatively salvaged blood of cancer patients undergoing surgery to prevent metastasis and the benefit to the public from use of the device.

These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with information submitted to the public docket, postmarket data, adverse event reports in the MAUDE and MDR databases, information in CDRH's Medical Device Recalls database, and published scientific literature.

FDA proposes that any final rule based on this proposed rule become effective 30 days after its date of publication in the Federal Register . If this classification action is finalized, FDA proposes the implementation strategy set forth below.

• Blood irradiators intended to prevent TA-GVHD proposed to be classified into class II that have not been legally marketed prior to the effective date of any final rule, or blood irradiators intended to prevent TA-GVHD that have been legally marketed, but are required to submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified and have not submitted such 510(k) by the effective date of any final rule: FDA is proposing that manufacturers would have to obtain 510(k) clearance before marketing the new or modified device and would be required to comply with the applicable special controls as of the effective date. We believe that 30 days is a reasonable effective date given that FDA would not have received updated submissions regarding, and therefore would not have familiarity with, the noncompliant devices in this category, and given the concern about the probable consequences of device failure, including TA-GVHD, which can result in patient death.

• Blood irradiators intended to prevent TA-GVHD proposed to be classified into class II that have been legally marketed prior to the effective date of any final rule and are not about to be significantly changed or modified in a manner that requires a 510(k), and blood irradiators intended to prevent TA-GVHD for which 510(k) submissions have been submitted before the effective date of any final rule: FDA generally does not intend to enforce compliance with the special control requirements, including the labeling requirements, for a period of 12 months following the effective date of the final rule, although FDA intends to carefully assess the application of this policy to any devices for which submissions are made between the date of publication of the final rule and the effective date. If a manufacturer were to market such a device after 12 months following the effective date of the final rule, and that device did not comply with the special controls, the enforcement discretion policy described above would no longer apply, meaning FDA would evaluate enforcement action against such a manufacturer under its usual approach. FDA believes that a period of one year from the effective date of this final rule would be appropriate for manufacturers to come into compliance with such requirements, as we are generally familiar with these devices and we believe changes for existing devices to come into compliance are generally limited to minor labeling changes. We also believe this compliance period is appropriate to accommodate the reliance interests of manufacturers who have developed products and submitted premarket notifications based on the previous regulatory status quo, under which blood irradiators are subject to 510(k) requirements but not special controls. FDA believes this approach would help ensure the efficient and effective implementation of the classification action, if finalized as currently proposed.

• If this proposal to classify blood irradiators intended to prevent metastasis in class III and the related proposed order to require the approval of a PMA are finalized, blood irradiators intended to prevent metastasis by delivering a controlled radiation dose to irradiate intraoperatively salvaged blood of cancer patients undergoing surgery to prevent metastasis would be considered adulterated if either a PMA is not filed with FDA prior to the last day of the 30th calendar month beginning after the month in which the classification of the device into class III becomes effective or a PMA is filed but approval is denied, suspended, or withdrawn (see section 501(f)(1)(A) and 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(1)(A) and (2)(B))).

In this event, the device can no longer be introduced into interstate commerce (see, e.g., section 301(a) of the FD&C Act (21 U.S.C. 331(a))) unless it meets a relevant exemption, such as the exemption for investigational use devices. The requirements of the investigational device exemption regulations are set forth in 21 CFR part 812.

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 14192, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866 and 13563 direct us to assess all benefits and costs of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits. Rules are economically significant under Executive Order 12866 if they have an annual effect on the economy of $100 million or more; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The Office of Information and Regulatory Affairs has determined that this proposed rule is not a significant regulatory action under Executive Order 12866.

Executive Order 14192 requires that any new incremental costs associated with certain significant regulatory actions “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This proposed rule, if finalized as proposed, is not expected to be an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because net annualized compliance costs of the proposed rule are more than 1 percent of average annual revenues and unquantified effects are uncertain, we find that the proposed rule will have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (Section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” The current threshold after adjustment for inflation is $187 million, using the most current (2024) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

The proposed rule, if finalized, would classify blood irradiators (unclassified, preamendments devices) into two classes based on intended use. It would classify blood irradiators intended to prevent TA-GVHD into class II (special controls) and blood irradiators intended to prevent metastasis into class III (premarket approval application). The proposed special controls for blood irradiators intended to prevent TA-GVHD are already generally practiced by manufacturers of currently cleared devices, with the primary change consisting of the labeling special controls. FDA believes that the proposed special controls, together with the general controls in the FD&C Act, would provide reasonable assurance of the safety and effectiveness of these devices and help ensure that all new devices meet the same standards as the currently marketed devices. FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for blood irradiators intended to prevent metastasis, and that these devices present a potential unreasonable risk of illness or injury. Separately, FDA also is issuing a proposed order requiring the filing of a PMA for blood irradiators intended to prevent metastasis.

Quantified benefits of the proposed rule, if finalized, would consist of cost savings to industry and FDA from a reduction in the quantity and time burden of informal inquiries related to blood irradiators intended to prevent TA-GVHD. We also estimate cost savings to industry and FDA from a reduction in the number of 510(k) submissions necessitating requests for additional information from FDA before and during review. Industry and FDA could incur costs associated with premarket approval for current and future blood irradiators intended to prevent metastasis. Industry would incur costs to prepare and submit PMAs and annual and supplemental reports and costs to undergo facility inspections. In turn, FDA would incur costs to review and respond to PMAs and annual and supplemental reports, and costs to inspect facilities. We quantify the associated user fees for these PMAs and annual and supplemental reports as transfers from industry to FDA. We additionally quantify one-time costs to industry to read and understand the proposed rule and the proposed order requiring the filing of a PMA, as well as one-time costs to industry to revise labeling.

We summarize the quantified benefits and costs of the proposed rule, if finalized, in Table 2. We estimate that the annualized benefits over 10 years would range from $84 to $180,268 at a 7 percent discount rate, with a primary estimate of $90,176, and from $86 to $184,271 at a 3 percent discount rate, with a primary estimate of $92,178. The annualized costs would range from $0.68 million to $1.51 million at a 7 percent discount rate, with a primary estimate of $1.07 million, and from $0.66 million to $1.53 million at a 3 percent discount rate, with a primary estimate of $1.07 million.

We have developed a Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 17) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

We have 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.

FDA tentatively concludes that this proposed rule contains no new collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. 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 and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 892 be amended as follows:

The 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).

Under section 513(d)(1) of the FD&C Act, devices that were in commercial distribution before the enactment on May 28, 1976, of the 1976 amendments (Medical Device Amendments of 1976, Pub. L. 94-295) (generally referred to as “preamendments devices”) are classified after FDA (we or the Agency) has: (1) received a recommendation from the appropriate device classification panel (which are part of the FDA Medical Devices Advisory Committee); (2) published the panel's recommendation and a proposed regulation classifying the device for comment; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

A person may market a preamendments device that has been classified into class III through premarket notification procedures, without submission of a PMA until FDA issues an administrative order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.

Section 515(f) of the FD&C Act provides an alternative pathway for meeting the premarket approval requirement. Under section 515(f), manufacturers may meet the premarket approval requirement if they file a notice of completion of a product development protocol (PDP) approved under section 515(f)(4) of the FD&C Act and FDA declares the PDP completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the manufacturer of a preamendments class III device may comply with a call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, however, the option of filing a notice of completion of a PDP has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for filing and obtaining approval of a PMA.

Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) publication of a proposed order in the Federal Register ; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments from all affected stakeholders, including patients, payors, and providers.

Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) the proposed order; (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA, and the benefit to the public from the use of the device; (3) an opportunity for the submission of comments on the proposed order and the proposed findings; and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, 1 consideration of comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order requiring premarket approval for the device, or 30 months after the classification of the device in class III under section 513 of the FD&C Act becomes effective, whichever is later (section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B)). Elsewhere in this issue of the Federal Register , FDA is proposing to classify blood irradiators intended for use in the irradiation of intraoperatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis (blood irradiators intended to prevent metastasis) into class III. Therefore, if the proposed classification regulation and the order to require PMAs are finalized at the same time, a PMA for blood irradiators intended to prevent metastasis must be filed within the 30-month period because that will be the later of the two time periods. If a PMA is not timely filed for such devices, then the device would be deemed adulterated under section 501(f) of the FD&C Act.

Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) until the date identified by FDA in the final order requiring the filing of a PMA for the device (assuming it complies with other applicable FDA requirements). At that time, an IDE is required prior to interstate distribution of the device only if a PMA has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and obtains FDA approval, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE or otherwise exempt from the PMA requirements, the device is subject to enforcement action.

After the enactment of the Medical Device Amendments of 1976, FDA undertook an effort to identify and classify all preamendments devices in accordance with section 513(d) of the FD&C Act. Consistent with the FD&C Act, FDA held a Radiological Devices Panel meeting regarding the classification of blood irradiators, with product code “MOT,” on April 12, 2012 (2012 Panel) (Ref. 1). However, the 2012 Panel focused specifically on blood irradiators intended to irradiate blood and blood products to prevent transfusion-associated graft-versus-host disease (blood irradiators intended to prevent TA-GVHD), including those intended to inactivate leukocytes and/or lymphocytes to prevent TA-GVHD. The materials considered by the 2012 Panel noted that one device had been cleared at the time for the prevention of metastasis, but the classification of blood irradiators intended to prevent metastasis was not discussed at the 2012 Panel (Ref. 1).

On November 7, 2023, FDA held a Radiological Devices Panel meeting regarding the classification of blood irradiators intended to prevent metastasis (2023 Panel) (Ref. 2). FDA held the 2023 Panel to obtain input on the risks to health and benefits of blood irradiators intended to prevent metastasis. During the 2023 Panel meeting, FDA presented proposed risks to health for these devices. FDA identified risks which included some of the same risks that had been identified during the 2012 Panel for blood irradiators intended to prevent TA-GVHD relating to the device's hardware and software and some unique risks based on the device's intended use to prevent metastasis. FDA noted that based on available information, long-term safety risks related to the device's intended use are unclear. In addition, there appears to be a lack of clinical data to demonstrate a clear clinical benefit from use of blood irradiators intended to prevent metastasis. The 2023 Panel was asked to recommend to FDA whether blood irradiators intended to prevent metastasis should be classified into class III (premarket approval), class II (special controls), or class I (general controls).

The 2023 Panel reviewed the list of risks to health provided by FDA for blood irradiators intended to prevent metastasis and agreed with the risks to health identified by FDA. The 2023 Panel also identified several additional risks to health posed by the device's intended use. The 2023 Panel agreed with FDA that the list of risks to health identified for this device type may not be exhaustive due to the limited reported clinical use of blood irradiators when used for the prevention of metastasis. The 2023 Panel also agreed that the benefits of irradiating intraoperatively salvaged blood for cancer patients undergoing surgery is unknown based on lack of scientific evidence.

The 2023 Panel recommended that blood irradiators intended to prevent metastasis be classified into class III because there was a lack of available evidence to determine that general and special controls are sufficient to provide reasonable assurance of safety and effectiveness, and these devices present a potential unreasonable risk of illness or injury given the lack of probable benefit. FDA agrees with the Panel's recommendation that blood irradiators intended for the prevention of metastasis be classified into class III subject to PMA. It is also FDA's position that there is a lack of available evidence to determine that general and special controls are sufficient to provide reasonable assurance of the device's safety and effectiveness, and that the device presents a potential unreasonable risk of illness or injury.

Elsewhere in this issue of the Federal Register , FDA is proposing to classify blood irradiators intended to prevent metastasis into class III. FDA has tentatively determined that requiring PMA approval, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of these devices. The proposed classification action would also establish the identification, classification, and regulatory controls for blood irradiators intended to prevent TA-GVHD. These devices have been subject to premarket review through a premarket notification (510(k)) submission and have been cleared for marketing if FDA considers the device to be substantially equivalent to a legally marketed predicate in accordance with section 513(i) of the FD&C Act. To date, FDA has cleared 16 of these devices and cleared only two devices of the device type that will be subject to the PMA requirements. For these two devices, the prevention of metastasis is a second intended use for the device in addition to the intended use to prevent TA-GVHD.

If FDA finalizes the proposed classification of blood irradiators intended to prevent metastasis, these devices will be classified into class III. In accordance with sections 501(f)(2)(B) and 515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed with the Agency for blood irradiators intended to prevent metastasis by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III becomes effective.

An applicant whose product was in commercial distribution before May 28, 1976, or whose product has been found to be substantially equivalent to such a product, may continue marketing such class III product during FDA's review of the PMA, provided that a PMA is timely filed. FDA intends to review any PMA for the device within 180 days. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days, unless the Agency finds that “. . . the continued availability of the device is necessary for the public health.”

Moreover, manufacturers must cease distribution of blood irradiators intended to prevent metastasis upon receiving a denial decision rendered on a PMA. In such circumstances, to resume distribution of devices for this indication, these manufacturers must receive PMA approval for their devices. However, the product may be distributed for investigational use only if the requirements of the investigational device exemptions regulations in part 812 are met. The requirements for investigational use of significant risk devices include submitting an IDE application to FDA for review and obtaining approval. An IDE application under 21 CFR 812.30 is required to be approved before an investigation of the device may be initiated or continued. FDA, therefore, recommends that IDE applications be submitted to FDA at least 30 days before the date a PMA is required to be filed to avoid interrupting investigations.

Blood irradiators intended to prevent metastasis are used to irradiate intraoperatively salvaged blood ex vivo from cancer patients undergoing surgery to assist in the prevention of metastasis. Blood lost during surgery is collected using a suction device and may be processed or filtered before the blood irradiator is used to irradiate the blood to prevent the proliferation of cancer cells that may be present. The blood is then reinfused to the same patient either intraoperatively or post-operatively in an autologous blood transfusion. These devices include an x-ray or a sealed radiation source. FDA currently regulates these unclassified devices as devices requiring a 510(k) submission under product code MOT.

Elsewhere in this issue of the Federal Register , FDA is proposing to classify blood irradiators intended to prevent metastasis into class III. Blood irradiators are identified as follows: A blood irradiator device is a prescription device used to deliver a controlled radiation dose to blood or blood products. This generic type of device includes an x-ray or a sealed radiation source. Blood irradiators are class III when intended to irradiate intraoperatively salvaged blood in cancer patients undergoing surgery to assist in the prevention of metastasis.

In accordance with section 515(b)(2)(C) and (D) of the FD&C Act, interested persons are being offered the opportunity to comment or request a change on the Agency's proposed classification of blood irradiators intended to prevent metastasis published elsewhere in this Federal Register .

As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding: (1) the degree of risk of illness or injury designed to be eliminated or reduced by requiring that these devices have an approved PMA and (2) the benefits to the public from the use of the devices. These findings are based on the reports and recommendations of the 2023 Panel, and any additional information that FDA has obtained. Additional information regarding the risks can be found below, as well as in the proposed rule published elsewhere in this issue of the Federal Register , proposing to classify these devices into class III.

Based on this information, FDA has identified the following risks to health of blood irradiators intended to prevent metastasis:

• Damage to blood or blood components from radiation: Irradiation of whole blood and red blood cells causes damage to red blood cells and lymphocytes within the blood. Radiation damages the membrane of red blood cells leading to higher concentrations of potassium in plasma, hemolysis (destruction of red blood cells), and decreased red blood cell viability and survival.

• Unintended radiation exposure to the operator and others:   2 Device malfunction, lack of adequate maintenance, inadequate shielding, or safety control or interlock failure could allow the operator to access the radiation source resulting in physical injury and/or exposure of the operator or other nearby persons to radiation. Exposure to ionizing radiation has been shown to increase cancer risk (Ref. 3). Insufficient presence of safety controls or interlocks within irradiator design may result in unintended exposure.

• Electrical shock:   3 Electrical malfunction of the device or operator contact with an energized portion may result in electrical shock or burn. This can occur when there are insufficient or malfunctioning safety controls or interlocks.

• Mechanical or crush injury: Blood irradiators contain shielding materials to prevent excess radiation emission outside the device causing the device itself and many components to be heavy. Operator inattention or placement of body parts where they can be impinged by the device may result in physical injury to the operator.

• Presence of proliferative malignant cells in re-transfused blood due to incorrect dose or improper dose of radiation delivered: Incorrect dose of radiation identified to be effective or improper dose of radiation delivered due to operator error, device malfunction, lack of adequate maintenance, or lack of dosimetry or quality assurance checks, may result in tumor cell survival leaving proliferative ( i.e., able to function, grow, and divide) tumor cells present in the blood.

• Worsened control of oncologic disease or patient prognosis: Irradiating blood or blood components may cause an immune response that negatively impacts cancer outcome or patient recovery or survival.

• Delayed or lack of re-transfusion of irradiated blood or blood components: Use of the device inherently delays re-transfusion and lengthens the duration of the operating procedure with larger volumes of blood irradiated adding a larger amount of additional operating procedure time. Device malfunction, including from mechanical, electrical, or software malfunctions, or operator error could lead to improper or no irradiation of the blood or blood components, which could add additional delay if the malfunction or error results in the salvaged blood not being suitable for re-transfusion into the patient. Delay in re-transfusion could increase risk to patients depending on their blood volume at any given point in the procedure. Longer operating times are associated with increased risks, including prolonged exposure to anesthesia and greater risk of infection.

• Induction of a new cancer due to irradiation of the blood or blood components: Irradiation of nucleated cells may result in malignant transformation as ionizing radiation exposure causes DNA damage that may result in downstream biologic effects ( e.g., mutation, cell killing or carcinogenesis) (Ref. 4). Permanent DNA damage could result in the cells becoming malignant. Quantitative risk assessment of this phenomenon occurring in irradiated blood for the prevention of metastasis has not been performed. If blood salvage and processing, including irradiation, occurs multiple times, blood cells may be exposed to ionizing radiation multiple times. If those cells are returned into the body this could result in induction of a new cancer.

• Risks associated with usability including irradiating the salvaged blood outside the operating room, and the potential for blood to be incorrectly labeled or misidentified: Included in this risk to health are issues with operating the device in a way that results in an incorrect blood product being given to the patient. For example, should blood irradiation be performed in a manner where blood or blood products from multiple patients are irradiated at one time, if the bags are labeled with the wrong patient information, or are thought to be irradiated, but are not, this could result in the patient receiving a transfusion of the wrong blood. This could include operator error or inadequate usability testing of the points of interaction between the device and the operator, including displays and instructions for use.

FDA conducted a query of the Manufacturer and User Facility Device Experience (MAUDE) database and the Medical Device Report (MDR) database from 1984 through September 25, 2023, to identify adverse events related to use of blood irradiators, with product code MOT, which includes blood irradiators intended to prevent TA-GVHD and blood irradiators intended to prevent metastasis. The query resulted in the identification of five unique MDRs related to blood irradiators during that time period. No direct adverse events to patients were reported. FDA also conducted a query of Accidental Radiation Occurrences (AROs) reports during this time period. There were no AROs reported for devices under product code MOT. The MDR and ARO analyses showed few device malfunctions over the lifetime of use for these devices. Following these queries, FDA received one report of adverse events related to high current safety interlock system switch failures reported to result in superficial (first-degree) burns. FDA conducted updated queries for MDRs on July 7, 2025, and for AROs on November 7, 2024 and August 4, 2025. No additional reports were identified.

FDA reviewed recalls reported under product code MOT from November 2002 to June 22, 2025. There were two recalls for devices under product code MOT during that time period. The first recall was to complete a cooling system retrofit to preclude overheating and failure of the device. The recall was terminated May 13, 2012. 4 The second recall was for non-compliance with the associated performance standards within 21 CFR Subchapter J Radiological Health. Specifically, the device failed to comply with the performance standard for cabinet x-ray systems (21 CFR 1020.40)  5 because an interlock was not directly linked to the door. To address this issue, the company completed repairs during annual routine preventive maintenance visits at the users' sites to minimize downtime, and the recall was terminated August 1, 2017.

Additionally, FDA conducted a systematic literature review for articles published between January 1, 2002, and April 20, 2023, to identify and gather relevant published information regarding the safety and effectiveness of blood irradiators intended to prevent metastasis. The review identified 10 articles which were determined to be relevant to the safety and effectiveness of blood irradiators used to prevent metastasis. (Ref. 2, Executive Summary at pp. 11-12). No articles provided information on the safety assessment of blood irradiators intended to prevent metastasis. No articles definitively evaluated the effect of salvaged blood irradiation on tumor recurrence or metastasis. Further, the articles showed a lack of consensus on the specific dose to use, and for which cancer type and surgical procedure. FDA also conducted an additional literature search on September 23, 2024 for articles published since the prior search using the same search terms and filters and found no additional articles relevant to the safety and effectiveness of blood irradiators intended to prevent metastasis published since the prior search. Consequently, FDA tentatively concludes there is inadequate information characterizing the safety and effectiveness of blood irradiators intended to prevent metastasis to establish special controls. The 510(k) clearances of these devices were based solely on nonclinical information and determinations of substantial equivalence to a preamendments device. In light of the available information regarding the risks to health with no information supporting the benefit of these devices, general controls, including the 510(k) requirement, appear inadequate to support a reasonable assurance of safety and effectiveness for these devices. 6

This proposed rule, to be issued under the authority of the MMPA (16 U.S.C. 1361 et seq. ), establishes a framework for authorizing the take of marine mammals incidental to fisheries-independent research conducted by the TPWD in Texas bays and estuaries. TPWD fisheries research has the potential to take marine mammals due to possible physical interaction with fishing gear ( i.e., gillnets). TPWD submitted an application to NMFS requesting 5-year regulations and a letter of authorization (LOA) to take bottlenose dolphins ( Tursiops truncatus ) from seven stocks, by mortality/serious injury or injury (Level A harassment) incidental to research activities using gillnet fishing gear in Texas bays. The regulations would be valid for 5-years from the effective date of the final rule.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Section 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) directs the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made, regulations are promulgated (when applicable), and public notice and an opportunity for public comment are provided.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” ( i.e., mitigation) on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds and areas of similar significance, and the availability of the species or stocks for taking for certain subsistence uses, and must set the requirements pertaining to the mitigation, monitoring and reporting of the takings.

Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I, provide the legal basis for proposing and, if appropriate, issuing 5-year regulations and associated Letters of Authorization. This proposed rule also identifies a suite of proposed mitigation, monitoring, and reporting requirements for TPWD's activities.

The following is a summary of the major provisions of this proposed rulemaking regarding TPWD's fisheries research:

• TPWD staff and others involved in the proposed research activities will be required to attend the Protected Species Safe Handling, Release, and Identification Workshops prior to conducting the fisheries research activities.

• TPWD would eliminate dolphin “hot spot” sampling grids where bottlenose dolphins have been taken more than once since the beginning of the survey or grids where multiple adjacent grids have had at least one bottlenose dolphin encounter.

• TPWD would minimize soak time by utilizing the “last out/first in” strategy for gillnets set in grids where bottlenose dolphins have been encountered within the last 5 years.

• TPWD would set only new or fully repaired gillnets thereby eliminating holes greater than 6 inches (in) (15 centimeter (cm)) stretched mesh.

• TWPD would set gillnets with minimal slack and a short marker buoy attached to the deep end of the net.

• Staff would immediately respond to any net disturbance observed while gear is soaking.

• TWPD would modify gillnets to avoid more than a 4- in (10-cm) gap between float/lead line and net when net is set.

• TWPD would conduct dedicated marine mammal observations at least 15 minutes prior to setting nets and avoid setting nets if dolphins are observed at or approaching within the survey area.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) directs the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are proposed or, if the taking is limited to harassment, a notice of a proposed incidental harassment authorization (IHA) is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (collectively referred to as “mitigation”); and requirements pertaining to the monitoring and reporting of the takings. The definitions of all applicable MMPA statutory terms used above are included in the relevant sections below and can be found in section 3 of the MMPA (16 U.S.C. 1362) and NMFS regulations at 50 CFR 216.103.

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action ( i.e., the issuance of an LOA) with respect to potential impacts on the human environment.

In accordance with the NEPA (42 U.S.C. 4321 et seq. ) and NOAA policy and procedures (NOAA Administrative Order 216-6A and its Companion Manual), NMFS has prepared a draft environmental assessment (EA) analyzing the potential impacts of NMFS' proposed action of issuance of this rule and LOA(s). NMFS is seeking public comment on the draft EA. The draft EA is available at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-texas-parks-and-wildlife-departments-independent-fisheries for a 30 day public comment period. NMFS will consider all comments submitted in response to this notice prior to concluding the NEPA process or making a final decision on the request for regulations and a LOA(s).

On October 31, 2023, NMFS received a request from TPWD for a rulemaking and associated 5-year LOA to take marine mammals incidental to fisheries research activities. Following NMFS' review of the application, TPWD submitted a revised version on March 3, 2025. NMFS deemed TPWD's application adequate and complete on May 12, 2025. TPWD's request is for take of bottlenose dolphins by mortality and serious injury (M/SI) and by Level A harassment.

A notice of receipt of the application submitted by TPWD was published in the Federal Register on May 19, 2025, with a 30-day comment period. During the comment period NMFS received 50 comments from members of the public regarding TPWD's application for an incidental take authorization. Of the 50 comments received, 49 of them expressed general support for TPWD's request. One comment was opposed to issuing a LOA to TPWD citing that TPWD did not have a clear description in their application of how take was estimated for each stock of bottlenose dolphins, disagreed that TPWD's proposed gillnet configuration would allow entangled dolphins to breathe, and concerns that NMFS may not be able to make a negligible impact determination. NMFS has considered these comments in the preparation of this proposed rule.

TPWD conducts a long-term standardized fishery-independent monitoring program to assess the relative abundance and size of finfish and shellfish in Texas bays. Results from this program are primarily used by TPWD to manage Texas' marine finfish and shellfish resources. Data gathered through the survey are also used by multiple other state and federal agencies, universities, non-governmental organizations, and the private sector. The use of gillnets during these surveys may result in take by Level A harassment (injury) or M/SI of marine mammals.

These gillnet surveys are conducted throughout the coastal bay system of Texas and occur in the spring and fall. The spring season begins with the second full week in April and extends for 10 weeks. The fall season begins with the second full week in September and extends for 10 weeks. TPWD expects to set 780 gillnets annually within the Texas bay system.

Gillnets would be used in each of the 10 major Texas bay systems: Sabine Lake, Galveston, Cedar Lakes, East Matagorda, Matagorda, San Antonio, Aransas, Corpus Christi, upper Laguna Madre, and lower Laguna Madre (see figure 1). Each bay is separated into 1 minute by 1 minute grid cells and sampling sites are chosen at random. These bays consist of open-bay bottom ( i.e., mainly sand and mud bottom) habitat which are influenced by ocean waters through inlets. Marshes and intertidal flats typically make up the edges of the bays and are made up of relatively shallow water (Armstrong 1987).

The TPWD bay gillnet finfish surveys, conducted in the spring and fall, provide fishery-independent measures of adult and subadult finfish relative abundance, diversity, and age and size distributions in Texas waters. Samples collected from this survey provide data for genetics, life history, and age and growth analyses. Seasonal sampling helps to address seasonal differences in fish behavior, diversity, and relative abundance in the coastal bay systems of Texas. Nets are set at least 1 hour before sunset, soak overnight, and are retrieved within 4 hours of sunrise.

Each coastal bay is divided into 1 minute latitude by 1 minute longitude grids (see figure 6 a-f in TPWD's application). One grid is selected for each net to be set and that grid will only be chosen once in a given season ( i.e., spring or fall). Prior to each gillnet season, the grids that will be sampled that season are randomly selected from the subset of grids called gridlets. The specific sample sites are then randomly selected from gridlets (5 second latitude by 5 second longitude divisions, 144 per grid) that contain less than 15.2 m of shoreline. If it is determined in the field that the randomly selected gridlet cannot or should not be sampled, the nearest 15.2 m section that can be safely sampled is designated as an alternate. No more than one gillnet is set in the same grid on any night or is set more than one time in the same grid in a season. Gillnets set on the same night must be at least 1 kilometer (km) apart in all directions. If adjacent grids are randomly selected and are to be sampled on the same night, one of the grids is chosen at random and then a gridlet is selected. The gridlet in the adjacent grid is chosen from all gridlets that are at least 1 km from the initial selected site.

The gear configuration of the gillnets includes variable mesh sizes to target different size fishes. This includes juvenile and mature finfish species, which provide data on the size and age structure of the finfish community. The data collected in the TPWD bay gillnet sampling activities provide a fishery-independent measure of adult and subadult finfish abundance which can be used to complement fishery-dependent data and is used by TPWD to manage many of the coastal Texas finfish species.

The gillnets used by TPWD are made of monofilament mesh at 1.2 meters (m) in height attached to a lead line made of a braided line with a solid core with a breaking strength of 22.7 kilograms at a length of 18.9 m. on the bottom of the net and a float line at the top of the net with hard plastic bullet shape floats spaced 101 cm to 114 cm apart. The total length of a net is 182.9 m with 45.7 m sections of 7.6 cm, 10.2 cm, 12.7 cm, and 15.2 cm stretched mesh joined together with monofilament line up the entire height of the net, with no gaps between the different mesh sizes, to make one continuous net (see figure 2 of TPWD's application).

The gillnets set by TPWD are set perpendicular to the shoreline with the smaller mesh end of the net anchored to the shoreline and the progressively larger mesh extending seaward for 182.9 m (see figures 4 and 5 of TPWD's application). When deployed the nets are pulled tight to remove any slack while the net is fished in turn, reducing the likelihood of marine mammal entanglement. Gear retrieval occurs at sunrise or no later than 1 hour after sunrise and within 4 hours of sunrise all nets are retrieved. TPWD typically fishes gillnets for 12 to 14 hours once the gillnets are set. TPWD's use of gillnets is likely to result in incidental take of bottlenose dolphins, including M/SI.

TPWD conducts Gulf Finfish and Shellfish Trawl Surveys in open waters of the Texas Territorial Sea (state waters 0-13 (0-21 km) nautical miles adjacent to inlets of coastal bays) in waters seaward of the Texas shoreline to determine relative abundance, size, distribution, and species composition of various life history stages of fish and invertebrates.

These surveys are conducted in the same manner as the Interjurisdictional Fisheries Act (IJA) Open Bay Shellfish Trawl Survey, which outlines standardized gear configuration and sampling protocols for trawl gear for shellfish sampling. The trawl configuration is 6.1 m wide otter trawls with 38 millimeters (mm) stretched nylon multifilament mesh throughout. Trawl doors are 1.2 m long, and 0.5 m wide and constructed of 13 mm plywood with angle iron framework and iron runners. Trawls would be deployed from research vessels and towed at 4.8 km per hour (kmh), actively towed for 10 minutes, and retrieved aboard the vessel. As vessels tow the trawl gear the vessel would travel parallel to a designated fathom curve. TPWD's gulf trawls are identical in gear, speed, and duration as the bay trawls. TPWD has never incidentally taken a bottlenose dolphin or any other marine mammal during the gulf and bay trawls during the history of the program. On average the TPWD will deploy 80 gulf trawls per month/960 per year and 1,080 bay trawls per year. Given that there have been no incidental takes of bottlenose dolphins or any other marine mammal over the course of the trawl survey TPWD does not anticipate take to occur incidental to this activity.

Oyster reef surveys are conducted by TPWD to collect data on oyster populations in the surrounding coastal waters of Texas. Oyster dredge samples are collected from areas in which Eastern oysters form consolidated oyster reef/habitat and exhibit ≥0.2 m (6 in) vertical relief from adjacent bay bottom for a continuous distance of at least 91.4 m (300 ft) in length by 0.5 m (1.5 ft) in width. Sampleable reefs must be located at a water depth of ≥1 m (3 ft) during mean low tide on current nautical charts. All known mapped oyster reefs/habitats are included as oyster habitat strata for potential oyster dredging sites.

The coastal fisheries oyster dredge gear used by TPWD during the oyster surveys consist of a frame and a bag. The frame, constructed with 13-mm cold rolled steel rod, is 0.5 m wide, 0.24 m high and 1 m long (figure 1 of TPWD's application). The bag, constructed with metal rings, metal s-hooks and nylon rope, is 0.36 m deep with 76-mm stretched mesh braided nylon solid core webbing (see figure 1 of TPWD's application). The dredge is deployed from either skiffs or research vessels, towed along the known contour of the oyster reef at 4.8 kmph for 30 seconds, and retrieved aboard the vessel. Due to the small size of the oyster dredges, structure, short tows, and slow speeds TPWD considers this gear to be a very low risk for bottlenose dolphin encounters. The oyster dredge is towed approximately 100 times per month and 1,200 times per year.

TPWD is also conducting comparison studies using oyster tongs to collect oyster reef data. Hydraulic tongs are 0.447 m wide by 0.532 m deep (covering a total area of 0.238 m 2 ). They are affixed to a hydraulic winch via steel cable or winch rope. When deployed, tongs are lowered from the side of a vessel and allowed to rest completely on the bottom before being hydraulically closed and retrieved. NMFS does not expect the use of the oyster dredge or the oyster tongs by TPWD to result in the take of bottlenose dolphins or any other marine mammal.

TPWD also utilizes bathymetric sidescan sonar and singlebeam echosounders to characterize and map aquatic habitats, select sites for oyster restoration, and conduct post-restoration habitat monitoring. Habitat mapping is critical to informing resource management decisions, allowing TPWD to evaluate how habitat distribution and health have changed over time, and prioritize conservation and restoration efforts to address habitat loss in certain locations.

Using sonar is critical to the success of oyster restoration projects as it is used in both the planning and evaluation of these projects. TPWD uses non-impulsive intermittent sonar surveying equipment, including multi-frequency bathymetric sidescan sonar, single-frequency singlebeam echosounders, and single-frequency split-beam echosounders. TPWD collects bathymetric sidescan sonar data using a dual-frequency EdgeTech 6205 units. This unit operates at both 230 and 550 kilohertz (kHz) simultaneously, has a maximum source level of 200 dB (decibels) ref 1 uPa (micro Pascale), a pulse rate of 15 seconds and a pulse duration of 1 millisecond (ms). TPWD also uses various recreational grade sidescan sonar units, such as Humminbird and Garmin, for intermittent survey work for very small projects. The frequency of these units ranges from 200 kHz to 1200 kHz. These units are used to inform sampling locations for fisheries-independent oyster monitoring, as well as for planning and monitoring oyster restoration projects. All units used are in a downward-looking position with no tilt. These sidescan sonars operate at a frequency outside the hearing range of bottlenose dolphins ( i.e., >160 kHz) and therefore, NMFS does not expect the use of this sonar to result in take of bottlenose dolphins or any other marine mammal.

TPWD also collects singlebeam echosounding data using Biosonics DT-X systems with one single-beam 120 kHz echosounder and one split-beam 426 kHz echosounder. The Biosonic DT-X system has user-defined ping rate ranging from 0.01 to 30 pings per second and is typically operated at 10 pings per second. Pulse duration is user-selectable between 0.1 to 1.0 ms and is typically operated at 0.2 ms.

The beam pattern of the Biosonics DT-X 120 kHz is extremely narrow ( i.e., 10 degrees) and at that frequency and echosounder is oriented downward (not obliquely) in waters with an average depth of 2.5 m, thus ensonifying a very small circular area approximately 0.5 m in diameter. The echosounder uses a rapid duty cycle of 0.002 with pulse durations of 0.2 ms and a pulse rate of 10 pulses per second. This results in an extremely short duration of ensonification and reduces the effective source level (NMFS 2020). Because of the orientation, shallow water depths (<4 m), beam pattern, and rapid duty cycle, we would only expect minimal exposures within this frequency. A study investigating the impact of a similar echosounder system as the one used by TPWD (a 120 kHz singlebeam echosounder with a beam width of 7 degrees and a source level of 230 dB) found that likelihood of TTS occurs only in a small volume of water immediately under the transducer (Boebel et al. 2005). NMFS does not expect the take of any marine mammals incidental the use of these echosounders during habitat mapping activities.

Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).

Sections 3 and 4 of TPWD's application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs) ( https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website ( https://www.fisheries.noaa.gov/find-species ).

Table 1 lists all species or stocks for which take is expected and proposed to be authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs) defined in section 3 of the MMPA (16 U.S.C. 1362(20)). Since serious injury or mortality is anticipated to be authorized under this action, PBR and annual M/SI from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.

To provide a background for how estuarine bottlenose dolphin stocks are identified, we provide the following excerpt from the Bottlenose Dolphin Stock Structure Research Plan for the Central Northern Gulf of America (GOA) (NMFS 2007) which more specifically describes the stock structure of bottlenose dolphins within the bays, sounds, and estuaries of the GOA. The distinct stock status for each of the 31 inshore areas of contiguous, enclosed, or semi-enclosed bodies of waters is community-based. That is, stock delineation is based on the finding, through photo-identification (photo-ID) studies, of relatively discrete dolphin “communities” in the few GOA areas that have been studied (Waring et al., 2007). This finding was then generalized to all enclosed inshore GOA waters where bottlenose dolphins exist. A “community” consists of resident dolphins that regularly share large portions of their ranges and interact with each other to a much greater extent than with dolphins in adjacent waters. The term emphasizes geographic and social relationships of dolphins. Bottlenose dolphin communities do not necessarily constitute closed demographic populations, as individuals from adjacent communities may interbreed.

Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. Atlantic SARs. All values presented in table 1 are the most recent available at the time of publication (including from the draft 2024 SARs) and are available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments.

As indicated above, bottlenose dolphins (with seven managed stocks) listed in table 1 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur.

Bottlenose dolphins have been identified in seven distinct coastal stocks within the inner estuaries of Texas (table 1). Shane (1977) and Gruber (1981) documented year-round residency of individual common bottlenose dolphins in some of the estuarine waters of Texas coastal bays. Analysis of genetic data supports the fact that many of the coastal Texas stocks are comprised of resident populations (NMFS 2021). In general, the Texas coastal stocks only occur in discrete BSE waters. However, it has been documented that limited mixing does occur in the passes of the Gulf of America with other non-resident stocks (NMFS 2021).

NMFS has acknowledged that as additional information about these BSE stocks becomes available, combination or further division of the stocks or modification of the stock boundaries may be warranted (NMFS 2021). Population size across the seven coastal stocks in Texas is a wide range ( e.g., N 37-842).

NMFS used unpublished data provided by the Southeast Fisheries Science Center (SEFSC) for a population estimate to update the Matagorda Bay, Tres Palacios Bay, Lavaca Bay stock. The SEFSC conducted stock structure research (biopsy sampling surveys) from 2012-2014. During the biopsy sampling, photos were taken for photo-ID and 285 individual dolphins with distinct dorsal fins were identified within this stock's boundaries (NMFS SEFSC, UNPUBLISHED DATA). This provided an abundance estimate (N best ) of 150 individuals from this stock. The N best value of 150 individuals was used to calculate an estimated PBR for this stock given one is not available in the recent SARs.

Recently, the SEFSC, in collaboration with Texas A&M University researchers, developed provisional minimum population estimates or N mins for three of the seven stocks that had unknown N mins ; these included the Copano Bay/Aransas Bay/San Antonio Bay/Redfish Bay/Espiritu Santo Bay Stock, Nueces Bay/Corpus Christi Bay Stock, and the Laguna Madre Stock. The report used photo-identification data collected by Texas A&M University of these stocks from 2018 to 2025. Individual animals were assigned to a stock based on the majority of their sighting locations. For individuals sighted one time, data was examined from animals seen multiple times to estimate the probability of a given stock assignment conditional on its being seen within a given stock area on its first observation. A transient area was defined for the Aransas Pass and animals sighted in that area were not included in the population estimate due to the likelihood of sighted animals being from coastal stocks. Additional details on the methods used by the SEFSC are in the 2025 report which is available on the NMFS website at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-texas-parks-and-wildlife-departments-independent-fisheries .

NMFS then used these updated N min values to calculate PBR values for the three stocks (Garrison 2025). The PBR formula NMFS used to calculate PBR is (N min * 0.5R max * F r ) where R max is the maximum net productivity rate and the F r is the recovery factor. The R max and the F r values for bottlenose dolphins are available in table 1 of the draft 2024 SARs. The data used for each stock and resultant PBR is shown in table 2.

The stocks for which NMFS proposes to authorize take associated with the TPWD's gillnet fisheries research are grouped in the GOA BSE SAR. As discussed above, NMFS received data from Texas A&M researchers and consulted with the SEFSC to develop updated N min estimates for the Copano Bay/Aransas Bay/San Antonio Bay/Redfish Bay/Espiritu Santo Bay stock, Nueces Bay/Corpus Christi Bay stock, and the Laguna Madre stock. Further, information was available from the SEFSC for the Matagorda Bay/Tres Palacios Bay/Lavaca Bay stock that informed population estimates. For the remaining stocks NMFS is proposing to use the information from the SARs for M/SI and N min values.

NMFS considered take by M/SI relative to residual PBR ( i.e., the PBR value subtracted from the estimate of ongoing anthropogenic M/SI). NMFS gathered information on reported serious injury determinations from Maze-Foley and Garrison (2024) and reported mortalities from the Marine Mammal Stranding Database (excluding those that have occurred during the proposed TPWD surveys) to estimate annual rates of M/SI (table 7) (see the Negligible Impact Determination section for additional description of residual PBR and how it is calculated). NMFS identified five mortalities and 10 serious injuries over the 2019 to 2023 time period as analyzed in Maze-Foley and Garrison (2024) (the most recent information available). Three of the five mortalities were from hook and line fishing gear, two of which were from the Copano Bay/Aransas Bay/San Antonio Bay/Redfish Bay/Espiritu Santo Bay and the remaining one from the Nueces Bay/Corpus Christi Bay stocks. The other two mortalities were determined to be from vessel strikes and were from the Nueces Bay/Corpus Christi Bay and Galveston Bay/East Bay/Trinity Bay stocks. Of the 10 serious injuries five were from the Galveston Bay/East Bay/Trinity Bay stock from hook and line gear, trap pot gear, and entanglements with unidentified fishing gear. Illegal gillnet gear entanglements and a vessel strike resulted in three serious injuries of the Laguna Madre stock. The remaining two serious injuries were from entanglements in unknown trap/pot gear from the Copano Bay/Aransas Bay/San Antonio Bay/Redfish Bay/Espiritu Santo Bay stock and a vessel strike of the Nueces Bay/Corpus Christi Bay stock.

NMFS has updated the M/SI estimates for all of the stocks where take is proposed. The M/SI data presented in the most recent SARs update for these BSE stocks was from 2015-2019. During the development of this proposed rule NMFS reviewed M/SI data from Maze-Foley and Garrison (2024) and the Marine Mammal Stranding Database which included data from 2019-2023. These data updated the annual M/SI estimates for all BSE stocks of bottlenose dolphins as shown in table 7 and are different from what is presented in the most recent update to the bottlenose dolphin BSE SARs report (see Negligible Impact Determination). This data represents the best available data for estimating the annual M/SI values for these stocks, including correcting an error for the Galveston Bay, East Bay, Trinity Bay stock where two serious injuries were assigned to the wrong stock incorrectly in Maze-Foley and Garrison (2024).

Unusual Mortality Events (UME)—The marine mammal UME program was established in 1991. A UME is defined under the MMPA as a stranding that is unexpected; involves a significant die-off of any marine mammal population; and demands immediate response. From 1992 through 2012, five UME events have occurred for Texas bottlenose dolphins and each has been closed. Three of the five UME causes were undetermined and the remaining two were caused by infectious diseases and biotoxins. More information related to UMEs is available on the NMFS website at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-unusual-mortality-events .

Biological Important Areas (BIAs)—In 2015, NOAA's Cetacean Density and Distribution Mapping Working Group identified BIAs for 24 cetacean species, stocks, or populations in 7 regions within U.S. waters, including the GOA. For BSE bottlenose dolphin stocks in the GOA the BIAs are areas in which small and resident populations are concentrated. BIAs are region-, species-, and time-specific.

Small and Resident Population: Areas and months within which small and resident populations occupying a limited geographic extent exist.

The delineation of BIAs does not have direct or immediate regulatory consequences. Rather, the BIA assessment is intended to provide the best available science to help inform regulatory and management decisions under existing authorities about some, though not all, important cetacean areas in order to minimize the impacts of anthropogenic activities on cetaceans and to achieve conservation and protection goals. In addition, the BIAs and associated information may be used to identify information gaps and prioritize future research and modeling efforts to better understand cetaceans, their habitat, and ecosystems. Table 3 provides a list of BIAs for bottlenose dolphins found within the TPWD's fisheries research areas.

This section provides a discussion of the ways in which components of the specified activity may impact marine mammals and their habitat. The Estimated Take of Marine Mammals section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take of Marine Mammals section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

As noted in the Detailed Description of the Proposed Activity section of this document, gillnet gear is the only gear used by TPWD that is expected to result in take of bottlenose dolphins. All other gears are not expected to have effects on marine mammals.

The gillnets used by the TPWD are similar to those used in gillnet fisheries throughout the GOA and the Atlantic. Read et al. (2006) estimated marine mammal bycatch in U.S. fisheries from 1990 to -99 and derived an estimate of global marine mammal bycatch by expanding U.S. bycatch estimates using data on fleet composition from the United Nations Food and Agriculture Organization. Most U.S. fisheries bycatch for cetaceans (84 percent) occurred in gillnets. Interactions and entanglements with gillnets may result in take by M/SI or at the very least injury (Level A harassment) for bottlenose dolphins (Read et al., 2006).

From 2019 through 2023, 243 commercial gillnet sets from the Atlantic coast of Florida throughout the GOA were observed by observers from the SEFSC. Effort has steadily declined in the strike gillnet fishery for king mackerel ( Scomberomorus cavalla ) and in the sink and drift gillnet fishery for Spanish mackerel ( Scomberomorus maculatus ) in the Atlantic and GOA. Incidental take of protected species, such as sea turtles and marine mammals, remained a low occurrence. A total of three protected species interacted with gillnets over the 5-year period, including one loggerhead sea turtle, one smalltooth sawfish, and one bottlenose dolphin and all were released alive (NMFS 2024).

TPWD has a history of taking bottlenose dolphins incidental to their gillnet research in the coastal bays of Texas. From 1983 through 2024, TPWD has set 31,386 gillnets throughout their sampling areas in the coastal bays of Texas. Over the 41 years of the survey TPWD has recorded 44 encounters with bottlenose dolphins with gillnet gear. NMFS began making injury determinations in 2007 for marine mammal injury events including entanglements with TPWD gillnet gear as reported to NMFS (77 FR 3233, January 23, 2012). Of the 44 dolphin encounters recorded by TPWD, 6 have been mortalities, 6 have been determined to be serious injuries, 10 were determined to be non-serious injuries (Level A harassment), 3 have not yet been determined or could not be determined, and the remaining 19 encounters with dolphins have an unknown disposition.

Effects on Prey—Gillnet sampling is designed to monitor finfish populations and some of these finfish species could be potential prey for bottlenose dolphins in the area. Habitat use by bottlenose dolphins is greatly dependent on prey availability. McDaniel (2022) grouped bottlenose dolphin prey species in Galveston Bay in order of importance based on their highest proportion consumed. White mullet ( Mugil curema ) was the highest proportion of prey species consumed at 25.3 percent of the overall diet of bottlenose dolphins. The second highest proportion of prey consumed by bottlenose dolphins in Galveston Bay was a group of species including Atlantic brief squid ( Lolliguncula brevis ), hardhead catfish ( Ariopsis felis ), and striped mullet ( Mugil cephalus ) at 21.0 percent. Recent analysis of fishery independent data collected by trawl and gillnets throughout the Texas coast indicate increasing abundance trends for striped mullet and Atlantic brief squid which indicate that gillnet sampling is not having a negative impact on these prey species for bottlenose dolphins (Williford and Anderson 2024). Gillnet sampling conducted by TPWD is limited in scope as compared with the overall available bay regions dolphins have to pursue prey species. The small number of prey species removed from the water during these gillnet sets are not expected to affect the availability of prey species for bottlenose dolphins in the coastal bays of Texas.

Physical Habitat—The use of gillnets by TPWD would be fished in habitat that is used by BSE stocks of bottlenose dolphins. Habitat used by these stocks of bottlenose dolphins ranges from shallow seagrass beds to dredged and natural channels and spoil island (Shane 1990; Scott et al., 1996; Barros 1993; Allen et al., 2000). Overall, the available data proposes that the range of diverse habitat used by bottlenose dolphins is influenced by foraging activity, seasonal shifts, and other behaviors such as socializing, traveling and resting.

TPWD does not set nets across the mouth of any inlets or channels during their sampling. Gillnets are primarily set in shallow waters with most of the gear either floating at the surface or suspended in the water column. The only part of the gillnet that makes contact with the sea floor is the lead line which is less than 1.27 cm in width and 182.9 m in length. This represents a very small area (2.4 m 2 ) when compared to the available habitat of bottlenose dolphins within the Texas bay systems. Anchors similar to the size of boat anchors are deployed to keep the net in place. The deployment and retrieval of the nets are completed by hand to avoid any disturbance to sea grass in the area.

As described above, the potential for TPWD's gillnet research to affect the availability of prey to marine mammals or to meaningfully impact the quality of physical habitat is considered to be insignificant for bottlenose dolphins. Effects on habitat will not be discussed further in this document.

This section provides an estimate of the number of incidental takes proposed for authorization under the rule, which will inform NMFS' consideration of “small numbers,” the negligible impact determinations, and impacts on subsistence uses. When discussing take, we consider three manners of take: mortality, serious injury, and non-serious injury (Level A harassment). Serious injury is defined as an injury that could lead to mortality while injury refers to an injury that could not lead to mortality. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment). No takes by Level B harassment are expected from TPWD's activities.

TPWD has a history of taking marine mammals incidental to their fisheries research using gillnet gear. The take resulting from gear interaction can range from mortality, serious injury, and Level A harassment (injury). TPWD has predicted the number of takes that would occur over the 5-year period of the rulemaking based on past encounters within the established stock boundaries of each Texas BSE bottlenose dolphin stock where take is expected. Each of these stocks has a respective survey block number ( e.g., B50) (also see figure 1) and TPWD further refined the survey blocks with 1 minute latitude by 1 minute longitude blocks where gillnets would be set (see figure 6a-f of TPWD's application). TPWD used a catch to effort calculation to estimate their expected annual take numbers.

In estimating take, TPWD used historical interactions data with bottlenose dolphins from 1983-2024 (table 4). Using this data, TPWD evaluated 5-year rolling averages for each survey block deriving the average number of encounters over each set of 5-years between 1983-2024. For example, in block 50 from 1983 through 2024, two rolling 5-year time periods had five encounters and one period had six. For this particular block, TPWD selected five encounters as the appropriate 5-year rolling total because it had the higher occurrence (twice between 1983-2024). TPWD chose the lower 5-year rolling total for this block since there was a high probability of that level of take occurring during the effective period of the requested LOA. For each of the blocks with interactions 5-year rolling totals were developed. TPWD then selected the highest recurring 5-year rolling totals for their estimated take levels (table 5). TPWD used these totals to inform their take request over the 5-year period of this proposed rule for each block with interactions of bottlenose dolphins (see Figure 1 for depiction of blocks relative to the different bays).

The Gulf reef fish fishery, which includes the Other SWG complex (composed of scamp, yellowmouth grouper, black grouper, and yellowfin grouper), is managed under the FMP. The FMP was prepared by the Council and NMFS, approved by the Secretary of Commerce, and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

All catch limits in this proposed rule are in pounds (lb) gutted weight.

The Magnuson-Stevens Act requires NMFS and the regional fishery management councils to prevent overfishing and achieve, on a continuing basis, the optimum yield from federally managed fish stocks. These mandates are intended to ensure fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and to protect marine ecosystems.

Scamp, yellowmouth grouper, black grouper, and yellowfin grouper were assigned to the Other SWG complex in the Generic Annual Catch Limits (ACL) and Accountability Measures (AM) Amendment (Generic ACL/AM Amendment) (76 FR 82044, December 29, 2011). These species were grouped into this complex for management proposes based on their similar fishery characteristics, such as habitat and harvest methods. The Other SWG stock complex ACL is set equal to the complex acceptable biological catch (ABC) which is currently 710,000 lb (322,051 kilograms (kg)) (50 CFR 622.41(c)(3)).

Commercial harvest of Other SWG species has been managed under the Grouper-Tilefish Individual Fishing Quota (IFQ) program since 2010 (74 FR 44732, August 31, 2009). The Generic ACL/AM Amendment apportioned the commercial sector a specified amount of the stock complex ACL based on historical harvest to allow the commercial sector to continue to operate under the IFQ program. The current commercial ACL is 547,000 lb (248,115 kg) and the commercial annual catch target (ACT, or quota) is 525,000 lb (238,136 kg), which is 4 percent below the commercial ACL. The buffer between the commercial quota and the commercial ACL was put in place to account for scientific uncertainty with the level of discards and allow for the IFQ flexibility measures under which some species in the deep-water grouper complex can be landed under the Other SWG quota. The Other SWG commercial quota has never been exceeded under the IFQ program.

Recreational fishing for all Other SWG species occurs throughout the Gulf except for black grouper, which more commonly occurs in the southeastern Gulf off Florida. There is no defined ACL for the recreational sector for the Other SWG complex. In defining the commercial apportionment, the Generic ACL/AM Amendment recognized that the difference between the stock complex ACL and the commercial ACL would allow for recreational harvest consistent with the historical levels. However, in recent years, recreational landings comprise an increasing proportion of overall landings for this complex. The recreational AM is linked to the stock complex ACL, and states that in the year following an overage of the stock complex ACL, recreational fishing will close when the stock complex ACL is projected to be reached. Because total landings have never reached the Other SWG stock complex ACL, the recreational AM has never been triggered. However, because the AM is based on reaching the stock complex ACL and the IFQ system allows commercial landings to occur year-round, this recreational AM may not effectively constrain harvest to the stock complex ACL if catch limits are reduced, as would occur under this proposed rule.

Until recently, no peer-reviewed stock assessment was available to inform stock status determinations for any Other SWG species. In 2022, the Southeast Data, Assessment, and Review 68 (SEDAR 68) assessed scamp and yellowmouth grouper together and indicated that harvest must be reduced. The Council's Scientific and Statistical Committee (SSC) accepted SEDAR 68 as consistent with the best scientific information available and recommended updated status determination criteria and catch levels for these two stocks. Black grouper and yellowfin grouper stocks could not be assessed due to a lack of the data necessary to accurately assess population metrics of these species in the Gulf.

In response to the SSC recommendations for scamp and yellowmouth grouper, the Council initiated work on Amendment 58A to the FMP (Amendment 58A), which considers dissolving the Other SWG complex and creating two new complexes, one for scamp and yellowmouth grouper and another for black grouper and yellowfin grouper, and setting catch limits for these new complexes. Amendment 58A also considers changes to the commercial IFQ program to reflect the two new complexes as well as other management measures. In recognition of the complexity of Amendment 58A and the additional time required for its development and implementation, the Council developed the current framework action to reduce harvest of scamp and yellowmouth grouper, consistent with the SSC recommendations, until Amendment 58A can be completed. The Council had been scheduled to approve Amendment 58A at its January 2026 meeting but decided to delay action pending the results of the Marine Recreational Information Program-Fishing Effort Survey pilot study, which may better inform the catch level recommendations in the amendment. Information on this study can be found at https://www.fisheries.noaa.gov/recreational-fishing-data/fishing-effort-survey-research-and-improvements.

This proposed rule and the framework action would reduce the current Gulf Other SWG complex ABC and stock complex ACL by 54.7 percent, which is based on the results of SEDAR 68 and the SSC original catch limit recommendations. The SSC reviewed updated SEDAR 68 projections information in May 2025 and provided new, slightly lower catch limit recommendations that are addressed in Amendment 58A but could not be incorporated into the current action because of the need to finalize the framework action at the June 2025 Council meeting. The proposed rule and the framework action would also implement a recreational fixed-closed season that is based on the predicted number of days needed to harvest the portion of the stock complex ACL available to the recreational sector (the difference between the stock complex ACL and commercial ACL). Currently, the Other SWG recreational season is open year-round, except for a SWG closure that is in place from February 1 through March 31 inshore of the 20-fathom rhumb line (50 CFR 622.24(d)). The measures in this proposed rule and the framework action are expected to reduce recreational harvest and reduce the likelihood of overfishing of scamp and yellowmouth grouper while additional management measures in response to SEDAR 68 are developed in Amendment 58A.

If implemented, this proposed rule would revise the stock complex and commercial ACL and quota (ACT) and set a recreational fixed closed season for the Other SWG complex.

Based on the results of SEDAR 68 and as described in the framework action, this proposed rule would reduce the stock complex ACL from 710,000 lb (322,051 kg) to 322,000 lb (146,057 kg), the commercial ACL from 547,000 lb (248,115 kg) to 255,000 lb (115,666 kg), and the commercial quota from 525,000 lb (238,136 kg) to 245,000 lb (111,130 kg). The commercial ACL and quota are rounded down to the nearest thousand lb (454 kg) from those presented in the framework action. This is done under the IFQ program to ensure that when allocation is distributed, the distributed allocation does not exceed the commercial quota. Without rounding, the distributed allocation could exceed the commercial quota based on how IFQ share percentages are calculated and the allocation is distributed.

NMFS expects the proposed catch limit reductions to result in reduced harvest and mortality of scamp and yellowmouth grouper, which would not occur under the status quo catch limits. Although commercial landings have never exceeded the proposed commercial quota and are expected to remain below the proposed quota in future years, these catch limits, when combined with the proposed recreational fixed-closed season, are expected to reduce mortality of scamp and yellowmouth grouper while the Council and NMFS work to implement Amendment 58A.

For the Other SWG complex, there is no recreational seasonal closure currently in place. This proposed rule would implement a recreational fixed closed season of January 1 through June 30, each year, resulting in an open season from July 1 through December 31, each year. During the proposed recreational closed season, the recreational harvest of Other SWG would be prohibited and the bag and possession limits for Other SWG in or from Gulf Federal waters would be zero.

The Council recommended implementation of a recreational fixed-closed season to reduce the recreational harvest of Other SWG consistent with the proposed reduction in the stock complex ACL. The framework action describes the method used to determine the proposed closed season, which is based on a July 1 opening and the predicted number of fishing days the recreational sector would need to harvest the amount of the stock complex ACL not allocated to the commercial IFQ program. The Council selected the July open date to provide some access during the summer but prevent harvest in June when historical landings have been the greatest and prevent overlap with the start of the Federal for-hire red snapper season when angler effort is very high. The proposed fixed-closed season is expected to result in substantially reduced effort and harvest by the recreational sector, which would help reduce the likelihood of overfishing scamp and yellowmouth grouper.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the framework action, the FMP, other provisions of the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866. This proposed rule is not an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification follows. A copy of the full analysis is available from NMFS (see ADDRESSES ). All monetary estimates in the following analysis are in 2024 dollars.

A description of this proposed rule, why it is being considered, and the objectives of this proposed rule are contained in the SUMMARY and SUPPLEMENTARY INFORMATION sections of this proposed rule.

The Magnuson-Stevens Act provides the statutory basis for this proposed rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. This proposed rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

This proposed rule would reduce the Other SWG stock complex ACL from 710,000 lb (322,051 kg) to 322,000 lb (146,057 kg) and reduce the commercial ACL from 547,000 lb (248,115 kg) to 255,000 lb (115,666 kg). The commercial ACT (quota) would be set at 245,000 lb (111,130 kg). This proposed rule would also establish a recreational fixed closed season for the Other SWG complex, with the recreational season set to open July 1 and to close on December 31. The proposed reduction in the Other SWG stock complex ACL would apply to SWG IFQ shareholders, as well as commercial fishing businesses, charter vessel and headboat (for-hire) fishing businesses, and recreational anglers that fish for Other SWG species in Federal waters of the Gulf. The proposed establishment of a recreational fixed closed season would apply only to recreational anglers and for-hire fishing businesses that fish for these species in Federal waters of the Gulf.

The RFA requires NMFS to describe the impact of the proposed rule on small entities (5 U.S.C. 603). Small entities include small businesses, small organizations, and small governmental jurisdictions (5 U.S.C. 601(3)-(6)). Recreational anglers are not businesses, organizations, or governmental jurisdictions, so they are outside the scope of this analysis.

Although this proposed rule would apply to for-hire vessels, it would not be expected to have any direct effects on these entities. From 2019 through 2023, there were an average of 2,447 target trips by charter mode for Other SWG in the Gulf, which accounts for just over 5 percent of all recreational target trips for Other SWG in the Gulf. In contrast, an average of 47,841 catch trips by charter mode for Other SWG in the Gulf were made from 2019-2023. This indicates that Other SWG fish are incidentally harvested species and for-hire vessels do not sell targeted trips for these fish. Therefore, NMFS does not expect the proposed changes to the Other SWG complex management measures to directly alter the services sold by these vessels. Any change in demand for these fishing services, and associated economic effects, as a result of this proposed rule would be a consequence of a change in anglers' behavior, secondary to any direct effect on anglers and, therefore, an indirect effect of the proposed rule. This indirect effect would fall outside the scope of the RFA. In summary, only the impacts on commercial fishing businesses will be discussed in this proposed rule.

As of July 8, 2021, there were 825 limited access valid or renewable Gulf reef fish permits. In order to commercially harvest species in the Other SWG complex, a vessel permit must be linked to an IFQ account and the account must possess sufficient allocation for the complex. IFQ accounts can be opened and valid permits can be linked to IFQ accounts at any time during the year. Eligible vessels can receive Other SWG complex allocation from other IFQ participants. On average from 2019 through 2023, there were 693 IFQ accounts that held Other SWG allocation and 490 that held Other SWG shares. During the same period, there were 301 federally permitted commercial vessels, on average each year, with reported landings of Other SWG species in the Gulf. Their average annual vessel-level gross revenue from all species for 2019 through 2023 was approximately $225,556 and Other SWG landings accounted for approximately 2 percent of this revenue. The maximum annual revenue from all species reported by a single one of the commercial vessels that landed Gulf Other SWG species from 2019 through 2023 was approximately $4.55 million in 2023. Economic profits for these commercial vessels are estimated to be 34.8 percent of their annual gross revenue, on average, or $78,493 per vessel during this period. Although many fishing businesses own only one permitted vessel, some hold or own multiple permits and vessels. Because complete ownership data for vessels that harvest Other SWG are currently unavailable, for the purposes of this analysis, NMFS assumes each of these 301 vessels is independently owned by a single business. This assumption is expected to result in an overestimate of the actual number of businesses directly regulated by this proposed rule. Additionally, 362 IFQ shareholder accounts, on average from 2019 through 2023, possessed Other SWG shares but did not report any landings of Other SWG species. These shareholders either transferred Other SWG allocation only or were inactive in the fishery. NMFS assumes that each of these accounts is independently owned by a single business as well. Revenue and cost data are not directly collected for IFQ shareholders, so estimates of their economic profits are not available; however, previous data for IFQ shareholders that hold gag shares suggest economic profits were approximately $73,000 per commercial fishing business in 2021.

For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (North American Industry Classification System (NAICS) code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. All of the commercial fishing businesses directly regulated by this proposed rule are believed to be small entities based on the NMFS size standard. No other small entities that would be directly affected by this proposed rule have been identified.

As stated earlier, this proposed rule would reduce the Other SWG stock complex ACL from 710,000 lb (322,051 kg) to 322,000 lb (146,057 kg) and reduce the commercial ACL from 547,000 lb (248,115 kg) to 255,000 lb (115,666 kg). The commercial ACT (quota) would be set at 245,000 lb (111,130 kg). Although the commercial ACL and ACT would be reduced by 53 percent relative to the status quo, based on 5-year average landings from 2018 through 2023, excluding 2020, commercial landings are expected to remain below the proposed commercial ACT in future years. Therefore, NMFS does not expect direct economic effects associated with a reduction in harvest.

There are potential price effects on the markets for Other SWG IFQ shares and allocation as a result of this proposed rule because the fixed supply of Other SWG IFQ allocation would become scarcer. However, these price effects cannot be quantified with available data. Allocation transfer prices may increase, which would increase the costs to some commercial fishing businesses that harvest Other SWG species or deep-water grouper species (speckled hind and warsaw grouper) that can be landed using Other SWG allocation under the flexibility measures established in Amendment 29 to the FMP (74 FR 44732, August 31, 2009). Assuming the percentage change in quantity of Other SWG allocation demanded is greater than the percentage change in price for Other SWG allocation, IFQ shareholders would experience an overall decrease in allocation transfer proceeds from an increase in allocation transfer prices and vice versa. With respect to IFQ share value, if investors believe that the discounted future revenue stream associated with shares is lower under the new commercial ACL than under the status quo commercial ACL, then share prices would be expected to decrease, otherwise they would remain the same or increase. Historically, Other SWG quota has been underutilized and NMFS expects commercial harvest will remain below the proposed commercial ACT. Therefore, demand for allocation would be unaffected and there would likely continue to be a surplus of allocation. In conclusion, any Other SWG allocation transfer price increases would likely be small due to competition among sellers.

Based on the above analysis, this proposed rule would not be expected to have a significant economic impact on a substantial number of small entities.

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

The Northeast Multispecies FMP specifies the management measures for 13 groundfish species, both target and non-target. The Northeast Multispecies FMP was prepared by the Council and is implemented by NMFS through regulations at 50 CFR part 648, consistent with the requirements of the Magnuson-Stevens Act. The groundfish fishery includes recreational and commercial components, and the members of the commercial fishery choose whether to fish as part of the sector program or the common pool. Annually, the commercial groundfish fishery has a value of approximately $40 million (ex-vessel revenue from the most recent complete fishing year). Recreational fisheries, including the recreational groundfish fishery, contribute substantial value to the regional and national economies.

Under the provisions of the Magnuson-Stevens Act, on behalf of the Secretary of Commerce, NMFS approves, disapproves, or partially approves measures that the Council proposes, based on consistency with the Act and other applicable law. Relying on the research and management track assessments; other scientific, commercial, and fishery data; economic, social, and ecological information and expertise; and public comments from numerous public meetings, the Council developed Amendment 25 to specify Status Determination Criteria (SDC), overfishing limits (OFL), acceptable biological catches (ABC), and annual catch limits (ACL), and set other management measures for all four cod stocks that are necessary to achieve optimum yield, prevent overfishing, and ensure accountability. NMFS has published a Notice of Availability (NOA) for Amendment 25 (91 FR 1257; January 12, 2026) that seeks public comment on the amendment through March 16, 2026. NMFS will consider comments received during the comment period for the Amendment 25 NOA in its decision to approve, partially approve, or disapprove Amendment 25, and will notify the Council by letter, pursuant to section 304(a)(3) of the Magnuson-Stevens Act.

NMFS also reviews proposed regulations for consistency with the fishery management plan, plan amendments, the Magnuson-Stevens Act and other applicable law. NMFS is seeking comments on these proposed regulations and, if Amendment 25 is approved in whole or in part, intends to promulgate the final regulations after careful consideration of any submitted comments. This proposed rule would incorporate revised Atlantic cod stock unites and associated requirements into the Northeast Multispecies FMP, as described in Amendment 25. This proposed rule also includes measures not specifically in Amendment 25, but which would be necessary for the management of the new stocks of cod, if approved, pursuant to section 305(d) of the Magnuson-Stevens Act. The Council reviewed the proposed regulations for Amendment 25 and deemed them consistent with, and necessary to implement, Amendment 25 in a December 5, 2025, letter from Council Chairman Daniel Salerno to Greater Atlantic Regional Administrator Michael Pentony, pursuant to section 303(c) of the Magnuson-Stevens Act. NMFS may consider comments submitted in response to this proposed rule in making a final decision to approve, partially approve, or disapprove Amendment 25 to the extent those comments are received during the NOA comment period. Consistent with Magnuson-Stevens Act requirements, NMFS will consult with the Council before making any revisions to the proposed regulations, if necessary, and will publish an explanation of any differences between the proposed and final regulations.

Under Magnuson-Stevens Act section 304(b)(1)(A), NMFS is required to publish proposed regulations consistent with the Council's recommendations, with such legal changes as may be necessary for clarity and an explanation of those changes for public comment). Therefore, through Amendment 25, and based on Council recommendations on transitioning the FMP from two stocks of cod to four stocks, NMFS proposes to:

• Incorporate the revised Atlantic cod stock unit definitions for Georges Bank (GB) cod, Eastern Gulf of Maine (EGOM) cod, Western GOM (WGOM) cod, and Southern New England (SNE) Atlantic cod into the Northeast Multispecies FMP;

• Set status determination criteria (SDC) for the Atlantic cod stocks;

• Set specifications including catch limits for four cod stocks: GB cod for fishing year 2026; and EGOM cod, WGOM cod, SNE cod for fishing year 2026-2027;

• Define the apportionment method for setting the WGOM cod commercial sub-annual catch level (ACL);

• Establish the management uncertainty buffers for the Atlantic cod stocks;

• Set recreational sub-ACLs for WGOM cod and SNE cod;

• Establish common pool trimester total allowable catch (TAC) distributions, TAC closure areas, and baseline common pool trip limits for the Atlantic cod stocks;

• Set recreational measures for SNE cod; and

• Establish a regulatory process for the Regional Administrator to set recreational measures for GB and EGOM cod for fishing year 2026.

In addition to the measures recommended by the Council in Amendment 25, this action also proposes measures that are not part of Amendment 25, but that may be considered and implemented under section 305(d) authority in the Magnuson-Stevens Act to make changes necessary to carry out the FMP. Through this rulemaking, NMFS proposes to set recreational management measures for WGOM, EGOM, and GB cod. Proposing these measures concurrently with Amendment 25 is intended to streamline the implementation because the measures are dependent on the proposed new stocks of cod being incorporated into the FMP.

The regulatory changes proposed in this rulemaking build upon the regulatory changes proposed in Framework Adjustment 69 to the FMP (90 FR 56836; December 8, 2025). The proposed regulatory changes below presume the implementation of the Framework 69 regulatory changes, rather than the current regulatory text.

Since the initial development of the Northeast Multispecies FMP in 1985, the fishery has been managed based on two Atlantic cod biological stock units: Gulf of Maine (GOM) cod and GB cod. Amendment 25 would revise the FMP to reflect four cod biological stock units as defined in the 2023 Research Track Assessment of Atlantic Cod: EGOM cod; WGOM cod; GB cod; and SNE cod. A peer review of the 2023 research track assessment accepted the outcomes of that assessment and its determination on the four-stock unit structure for cod, and this represents the best scientific information available. A copy of the Summary Report of the Atlantic Cod Research Track Stock Assessment Peer Review is available at: https://www.fisheries.noaa.gov/s3//2023-08/PanelSummaryReportoftheAtlanticCodRTPeerReviewAugust172023-mlt-508-8-23-23ajd-508gw.pdf.

In order to implement the management areas for the four new cod stocks, which are used for possession limits, minimum sizes, sector quotas, and other programs that are part of the Northeast Multispecies FMP, this action would define the geographical areas for the four cod stocks and management units (see figure 1). These areas would be codified in the Code of Federal Regulations (CFR) (see the proposed regulatory text below).