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Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes United States Area Navigation (RNAV) Routes Q-221 and Q-227; amends Very High Frequency Omnidirectional Range (VOR) Federal Airways V-35, V-147, and V-270 and RNAV Routes T-440 and T-445; and revokes VOR Federal Airway V-36 and Jet Routes J-132, J-223, and J-227 in the eastern United States. The FAA is taking this action due to the planned decommissioning of the Elmira, NY (ULW), VOR/Distance Measuring Equipment (VOR/DME). This action is in support of the FAA's VOR Minimum Operational Network (MON) Program.
Effective date 0901 UTC, September 5, 2024. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.
A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Brian Vidis, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.
The FAA published a NPRM for Docket No. FAA 2023-2315 in the
In a previous NPRM, Docket No. FAA-2023-1835 in the
The NPRM published for Docket No. FAA 2023-2315 in the
In a previous NPRM, Docket No. FAA-2023-1835 in the
Jet Routes are published in paragraph 2004, United States Area Navigation Routes (Q-routes) are published in paragraph 2006, Domestic VOR Federal Airways are published in paragraph 6010(a), and United States Area Navigation Routes (T-routes) are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
This action amends 14 CFR part 71 by establishing RNAV Routes Q-221 and Q-227; amending VOR Federal Airways V-35, V-147, and V-270 and RNAV Routes T-440 and T-445; and revokes VOR Federal Airway V-36 and Jet Routes J-132, J-223, and J-227 in the eastern United States. This action is due to the decommissioning of the Elmira, NY (ULW), VOR/DME. The ATS route changes are described below.
The navigational aid radials listed in the VOR Federal airway description regulatory text of this final rule are stated in degrees True north.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action of establishing RNAV Routes Q-221 and Q-227; amending VOR Federal Airways V-35, V-147, and V-270 and RNAV Routes T-440 and T-445; and revoking VOR Federal Airway V-36 and Jet Routes J-132, J-223, and J-227 in the eastern United States, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Dolphin, FL; INT Dolphin 266° and Cypress, FL, 110° radials; INT Cypress 110° and Lee County, FL, 138° radials; Lee County; INT Lee County 326° and St. Petersburg, FL, 152° radials; St. Petersburg; INT St. Petersburg 350° and Cross City, FL, 168° radials; Cross City; Greenville, FL; to Pecan, GA. From INT Dublin, GA, 309° and Athens, GA, 195° radials; Athens; Electric City, SC; Sugarloaf Mountain, NC; Holston Mountain, TN; Glade Spring, VA; Charleston, WV; INT Charleston 051° and Elkins, WV, 264° radials; Clarksburg, WV; to Morgantown, WV. From Philipsburg, PA; to Stonyfork, PA.
From Yardley, PA; INT Yardley 294° and East Texas, PA, 124° radials; East Texas; to Wilkes-Barre, PA. From Geneseo, NY; to Rochester, NY.
From Binghamton, NY; INT Binghamton 088° and Sparta, NJ, 344° radials; Chester, MA; INT Chester 091° and Boston, MA, 262° radials; to Boston.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes three United States Area Navigation (RNAV) Routes T-434, T-454, and T-458; and amends three United States RNAV Routes T-291, T-314, and T-634 in the eastern United States. This action supports Next Generation Air Transportation System (NextGen) which provides a modern RNAV route structure to improve the efficiency of the National Airspace System (NAS).
Effective date 0901 UTC, September 5, 2024. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11 and publication of conforming amendments.
A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, this final rule, and all background material may be viewed online at
FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Brian Vidis, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the NAS.
The FAA published a NPRM for Docket No. FAA 2023-2198 in the
Subsequent to publication of the NPRM, the FAA identified that the HYATT, PA route point was incorrectly listed as a Fix. The HYATT route point is identified as a waypoint (WP) in the NASR database and charted as a WP accordingly.
Additionally, the PAGER, NY, WP is removed from the route description of RNAV Route T-634 as it is a turn of less than one degree. The removal of the PAGER WP does not substantively alter the route. This final rule corrects these errors.
United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
This action amends 14 CFR part 71 by establishing RNAV Routes T-434, T-454, and T-458, and amending RNAV Routes T-291, T-314, and T-634 in the eastern United States. This action supports NextGen which provides a modern RNAV route structure to improve the efficiency of the NAS. The amendments are described below.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial
The FAA has determined that this action of establishing RNAV Routes T-434, T-454, and T-458, and amending RNAV Routes T-291, T-314, and T-634 in the eastern United States, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The Federal Aviation Administration (FAA) is issuing this final rule to permit all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when the operator of such aircraft is a foreign air carrier, to operate transiting overflights of the Kabul Flight Information Region (FIR) (OAKX) on jet routes P500-G500 at altitudes at and above Flight Level (FL) 300, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Afghanistan. The FAA became aware that certain U.S. operators were having difficulty using jet routes P500-G500 in the Kabul FIR (OAKX) at altitudes at and above FL320 due to aircraft performance issues under certain meteorological conditions. After consideration of Afghanistan's practice of publishing Notices to Air Missions (NOTAMs) regarding overflights on these jet routes, the lack of any reported security incidents posing safety-of-flight risks to civil aircraft overflights on these jet routes since the FAA issued this Special Federal Aviation Regulation (SFAR) in July 2023 or while the FAA flight prohibition NOTAM that preceded it was in effect, and the very brief period of time U.S. civil aviation overflights on these jet routes would be in the Kabul FIR (OAKX), the FAA has determined transiting U.S. civil aviation overflights operating on jet routes P500-G500 in the Kabul FIR (OAKX) at altitudes at and above FL300 present a low risk. The FAA continues to prohibit U.S. civil aviation operations in the remainder of the Kabul FIR (OAKX) at altitudes below FL320 due to hazards to persons and aircraft engaged in operations at those altitudes due to the risk posed by violent extremist and militant activity and the lack of adequate risk mitigation capabilities to counter such activity.
This final rule is effective on July 5, 2024.
Bill Petrak, Flight Standards Service, through the Washington Operations Center, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone (202) 267-3203; email
This action amends Special Federal Aviation Regulation (SFAR) No. 119, 14 CFR 91.1619, to permit U.S. civil aviation airmen and operators to conduct transiting overflights of the Kabul FIR (OAKX) on jet routes P500-G500 at altitudes at and above FL300, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Afghanistan.
On July 25, 2023, the Federal Aviation Administration (FAA) published a final rule in the
Subsequently, the FAA became aware that certain U.S. operators were having difficulty using jet routes P500-G500 in the Kabul FIR (OAKX) at altitudes at and above FL320 due to aircraft performance issues under certain meteorological conditions. After consideration of Afghanistan's practice of publishing NOTAMs regarding overflights on these jet routes, the lack of any reported security incidents posing safety-of-flight risks to civil aircraft overflights on these jet routes since the FAA issued SFAR No. 119, 14 CFR 91.1619, in July 2023 or while the FAA flight prohibition NOTAM that preceded it was in effect, and the very brief period of time U.S. civil aviation overflights on these jet routes, on which the minimum en route altitude is FL300, would be in the Kabul FIR (OAKX), the FAA assesses the risk to the safety of transiting U.S. civil aviation overflights operating on jet routes P500-G500 in the Kabul FIR (OAKX) at altitudes at and above FL300 is low. Under the FAA flight prohibition NOTAM preceding the July 2023 final rule, the FAA had previously permitted U.S. civil aviation to conduct transiting overflight operations in the Kabul FIR (OAKX) on jet routes P500-G500. The FAA
Therefore, the FAA is issuing this final rule to permit U.S. civil aviation to operate transiting overflights of the Kabul FIR (OAKX) on jet routes P500-G500 at altitudes at and above FL300, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Afghanistan.
The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. Sections 106(f) and (g) of title 49, U.S. Code (U.S.C.), subtitle I, establish the FAA Administrator's authority to issue rules on aviation safety. Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise this authority consistently with the obligations of the U.S. Government under international agreements.
The FAA is promulgating this rule under the authority described in 49 U.S.C. 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of the FAA's authority because it provides relief to U.S. civil aviation operators and airmen conducting transiting overflights of the Kabul FIR (OAKX) on jet routes P500-G500, permitting those persons to operate at altitudes at and above FL300, instead of at altitudes at and above FL320, as is required for operations conducted in the rest of the Kabul FIR (OAKX).
Section 553(b)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Also, section 553(d) permits agencies, upon a finding of good cause, to issue rules with an effective date less than 30 days from the date of publication. In this instance, the FAA finds good cause to forgo notice and comment and the delayed effective date because they would be impracticable and contrary to the public interest.
Providing notice and the opportunity for the public to comment here would be impracticable. The FAA's flight prohibitions, and any amendments thereto, need to include appropriate boundaries that reflect the agency's current understanding of the risk environment for U.S. civil aviation. This allows the FAA to protect the safety of U.S. operators' aircraft and the lives of their passengers and crews without over-restricting or under-restricting U.S. operators' routing options. However, the risk environment for U.S. civil aviation in airspace managed by other countries with respect to safety of flight is fluid in circumstances involving fighting, violent extremist and militant activity, or periods of heightened tensions, particularly where weapons capable of targeting or otherwise negatively affecting U.S. civil aviation are or may be present. This fluidity, and the potential for rapid changes in the risks to U.S. civil aviation, significantly limits how far in advance of a new or amended flight prohibition the FAA can usefully assess the risk environment. The delay that would be occasioned by providing an opportunity to comment on this action would significantly increase the risk that the resulting final action would not accurately reflect the current risks to U.S. civil aviation associated with the situation and thus would not establish boundaries for the flight prohibition commensurate with those risks.
While the FAA sought and responded to public comments, the boundaries of the area in which unacceptable risks to the safety of U.S. civil aviation existed might change due to: evolving military or political circumstances; violent extremist and militant group activity; the introduction, removal, or repositioning of more advanced anti-aircraft weapon systems; or other factors. As a result, if the situation improved while the FAA sought and responded to public comments, the rule the FAA finalized might be over-restrictive, unnecessarily limiting U.S. operators' routing options and potentially causing them to incur unnecessary additional fuel and operations-related costs, as well as potentially causing passengers to incur unnecessarily some costs attributed to their time. Conversely, if the situation deteriorated while the FAA sought and responded to public comments, the rule the FAA finalized might be under-restrictive, allowing U.S. civil aviation to continue operating in areas where unacceptable risks to their safety had developed. Such an outcome would endanger the safety of these aircraft, as well as their passengers and crews, exposing them to unacceptable risks of death, injury, and property damage that could occur if a U.S. operator's aircraft were shot down (or otherwise damaged) while operating in the Kabul FIR (OAKX).
Alternatively, if the FAA made changes to the area in which U.S. civil aviation operations would be prohibited between a notice of proposed rulemaking and a final rule due to changed conditions, the version of the rule the public commented on would no longer reflect the FAA's current assessment of the risk environment for U.S. civil aviation.
In addition, seeking comment would be contrary to the public interest because some of the rational basis for the rulemaking is based upon classified information and controlled unclassified information not authorized for public release. In order to meaningfully provide comment on a proposal, the public would need access to the basis for the agency's decision-making, which the FAA cannot provide. Disclosing classified or controlled unclassified information in order to seek meaningful comment on the proposal would harm the public interest. Accordingly, the FAA meaningfully seeking comment on the proposal is contrary to the public interest.
Therefore, providing notice and the opportunity for comment would be impracticable as it would hinder the FAA's ability to maintain appropriate flight prohibitions based on up-to-date assessments of the risks to the safety of U.S. civil aviation operations in airspace managed by other countries and contrary to the public interest as the FAA cannot protect classified and controlled unclassified information and meaningfully seek public comment.
For the same reasons discussed above, the potential safety impacts and the need for prompt action on up-to-date information that is not public would make delaying the effective date impracticable and contrary to the public
Accordingly, the FAA finds good cause exists to forgo notice and comment and any delay in the effective date for this rule.
On August 30, 2021, the FAA issued NOTAM KICZ A0029/21 to address the then-existing unacceptable risks to the safety of U.S. civil aviation operations in the Kabul FIR (OAKX) at all altitudes, except for transiting overflight operations on jet routes P500-G500. This NOTAM prohibited, with certain limited exceptions, U.S. civil aviation operations in the Kabul FIR (OAKX) at all altitudes by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and all operators of U.S.-registered civil aircraft, except when the operator of such aircraft is a foreign air carrier, due to the risk posed by violent extremist and militant activity, lack of adequate risk mitigation capabilities, and disruption to air traffic services. The NOTAM allowed U.S. civil aviation overflights to transit the Kabul FIR (OAKX) on jet routes P500-G500, as such operations are only in the Kabul FIR (OAKX) very briefly.
Following the Taliban takeover of Afghanistan, the International Civil Aviation Organization (ICAO) Asia-Pacific Office made contact with Afghanistan's civil aviation authority and stood up a contingency coordination team (CCT) composed of Afghanistan and neighboring air navigation service providers, as well as International Air Transport Association (IATA) representation. Afghanistan's civil aviation authority and the CCT worked with neighboring air navigation service providers to establish a contingency plan for the safe resumption of civil overflights in the Kabul FIR (OAKX).
Subsequently, Afghanistan issued a series of NOTAMs delineating overflight procedures and established altitude blocks for specific categories of flight operations across various regions. The overflight procedures rely upon internationally-recognized traffic information broadcasts by aircraft (TIBA) procedures, which pilots use in areas around the world where air traffic services are very limited or unavailable to maintain safe separation between aircraft. Consequently, the FAA determined that U.S. civil aviation operations throughout the Kabul FIR (OAKX) could resume at altitudes at and above FL320 due to diminished risks to U.S. civil aviation operations at those altitudes. On July 25, 2023, the FAA published in the
Although the FAA did not identify or assess that there existed any increased safety-of-flight risks to transiting U.S. civil aviation overflights operating on jet routes P500-G500 due to violent extremist or militant activity, the FAA prohibited operations on those routes at altitudes below FL320 in the July 2023 final rule because the Kabul FIR Air Traffic Management Contingency Plan indicates that, as necessary, FL300 may be reserved for military operations by NOTAM. Consequently, the FAA decided to establish a minimum allowed overflight level of FL320 for U.S. civil aviation operations in the entirety of the Kabul FIR (OAKX) to help ensure aircraft separation between any military operations being conducted in the Kabul FIR (OAKX) at FL300 and U.S. civil aviation overflights.
Since it issued the July 2023 final rule, the FAA has received two petitions for exemption from SFAR No. 119, § 91.1619, from U.S. air carriers requesting to operate on jet routes P500-G500 at altitudes at and above FL300 instead of at altitudes at and above FL320 as required by SFAR No. 119, § 91.1619, due to aircraft performance issues under certain meteorological conditions.
Since the publication of the Kabul FIR Air Traffic Management Contingency Plan and continuing since the FAA issued the July 2023 final rule, Afghanistan has issued a series of NOTAMs permitting overflight operations between waypoints FIRUZ and MOTMO on jet routes P500-G500 at altitudes between FL300-FL510. The FAA is not aware of any safety or security incidents experienced by civil aircraft operating on jet routes P500-G500 in the Kabul FIR (OAKX) at altitudes at or above FL300 due to military flight operations while FAA NOTAM KICZ A0029/21, which permitted U.S. civil aviation operations on that route, was in effect or since the July 2023 final rule. In addition, the FAA is not aware of any active threats to U.S. civil aviation operations on jet routes P500-G500 in the Kabul FIR (OAKX) from violent extremist and militant activity and is not aware of any reports of security incidents involving violent extremist and militant activity posing safety-of-flight risks to civil aircraft overflights using these jet routes at altitudes at or above FL300 in the Kabul FIR (OAKX), either while FAA NOTAM KICZ A0029/21 was in effect or since the issuance of the July 2023 final rule. The very limited flight time in the Kabul FIR (OAKX) minimizes both potential exposure to any military operations in the Kabul FIR (OAKX) that might be operating at FL300 and to potential opportunistic threats should a violent extremist observe or hear an overflying aircraft. Specifically, the flight distance between waypoints FIRUZ and MOTMO on jet routes P500-G500 is approximately 12 nautical miles, which takes approximately 95 seconds at cruising speeds.
Consequently, the FAA has determined that U.S. civil aviation overflights of the Kabul FIR (OAKX) at altitudes at and above FL300 on jet routes P500-G500 present a low risk. Although violent extremists and militants have access to weapons posing risks up to 25,000 feet, and there is high terrain in the vicinity of jet routes P500-G500, the FAA did not see such weapons used against civil aviation overflights on these jet routes during approximately 20 years of U.S. military presence in Afghanistan or since the coalition withdrawal in August of 2021.
Therefore, consistent with the foregoing, the FAA is amending SFAR No. 119, § 91.1619, to permit U.S. civil
However, this final rule continues to prohibit U.S. civil flight operations at altitudes below FL320 throughout the rest of the Kabul FIR (OAKX). Violent extremist and militant activities continue to pose safety-of-flight risks to U.S. civil aviation at altitudes below FL320 throughout the rest of Afghanistan. Violent extremists and militants are primarily armed with small arms, crew-served weapons, and field rockets and may have access to legacy man-portable air defense systems (MANPADS). Some MANPADS may be capable of reaching a maximum altitude of up to 25,000 feet above ground level; however, in the context of Afghanistan, the FAA must also account for the high altitude of some of the country's terrain. Allowing U.S. civil aviation operations in the Kabul FIR (OAKX) only at altitudes at or above FL320, other than on jet routes P500-G500, accounts for risks associated with the capabilities of weapons systems potentially available to violent extremist organizations and the terrain under other established international air routes in the Kabul FIR (OAKX).
Further amendments to SFAR No. 119, § 91.1619, might be appropriate if the risk to U.S. civil aviation safety and security changes. In this regard, the FAA will continue to monitor the situation and evaluate the extent to which persons described in paragraph (a) of this rule might be able to operate safely in the Kabul FIR (OAKX).
The FAA also republishes the details concerning the approval and exemption processes in sections V and VI of this preamble, consistent with other recently published flight prohibition SFARs to enable interested persons to refer to this final rule for comprehensive information about requesting relief from the FAA from the provisions of SFAR No. 119, § 91.1619.
In some instances, U.S. Government departments, agencies, or instrumentalities may need to engage U.S. civil aviation to support their activities in the Kabul FIR (OAKX). If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person described in paragraph (a) of SFAR No. 119, § 91.1619, including a U.S. air carrier or commercial operator, to transport civilian or military passengers or cargo or conduct other operations in the Kabul FIR (OAKX), except for transiting overflights on jet routes P500-G500 at altitudes at and above FL300, that department, agency, or instrumentality may request the FAA to approve persons described in paragraph (a) of SFAR No. 119, § 91.1619, to conduct such operations.
The requesting U.S. Government department, agency, or instrumentality must submit the request for approval to the FAA's Associate Administrator for Aviation Safety in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality.
The requestor must send the request to the Associate Administrator for Aviation Safety, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the FAA grants the request for approval. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Washington Operations Center by telephone at (202) 267-3203 or by email at
A single letter may request approval from the FAA for multiple persons described in SFAR No. 119, § 91.1619, or for multiple flight operations. To the extent known, the letter must identify the person(s) the requester expects the SFAR to cover on whose behalf the U.S. Government department, agency, or instrumentality seeks FAA approval, and it must describe—
• The proposed operation(s), including the nature of the mission being supported;
• The service the person(s) covered by the SFAR will provide;
• To the extent known, the specific locations in the Kabul FIR (OAKX) where the proposed operation(s) will occur, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the Kabul FIR (OAKX) and the airports, airfields, or landing zones at which the aircraft will take off and land; and
• The method by which the requesting department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of the proposed operations (
The request for approval must also include a list of operators with whom
If an approval request includes classified information or controlled unclassified information not authorized for public release, requestors may contact the Washington Operations Center for instructions on submitting it to the FAA. The Washington Operations Center's contact information appears in the
FAA approval of an operation under SFAR No. 119, § 91.1619, does not relieve persons subject to this SFAR of the responsibility to comply with all other applicable FAA rules and regulations. Operators of civil aircraft must comply with the conditions of their certificates, OpSpecs, and LOAs, as applicable. Operators must also comply with all rules and regulations of other U.S. Government departments, agencies, or instrumentalities that may apply to the proposed operation(s), including, but not limited to, regulations issued by the Transportation Security Administration.
If the FAA approves the request, the FAA's Aviation Safety organization will send an approval letter to the requesting U.S. Government department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:
(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator while still allowing the operator to achieve its operational objectives.
(2) Before any approval takes effect, the operator must submit to the FAA:
(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the Kabul FIR (OAKX); and
(b) The operator's written agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the Kabul FIR (OAKX).
(3) Other conditions the FAA may specify, including those the FAA might impose in OpSpecs or LOAs, as applicable.
The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy the FAA issues under chapter 443 of title 49, U.S. Code.
If the FAA approves the proposed operation(s), the FAA will issue an OpSpec or LOA, as applicable, to the operator(s) identified in the original request and any operators the requestor subsequently adds to the approval, authorizing them to conduct the approved operation(s). In addition, as stated in paragraph (3) of this section V.B., the FAA notes that it may include additional conditions beyond those contained in the approval letter in any OpSpec or LOA associated with a particular operator operating under this approval, as necessary in the interests of aviation safety. U.S. Government departments, agencies, and instrumentalities requesting FAA approval on behalf of entities with which they have a contract or subcontract, grant, or cooperative agreement should request a copy of the relevant OpSpec or LOA directly from the entity with which they have any of the foregoing types of arrangements, if desired.
Any operations not conducted under an approval the FAA issues through the approval process set forth previously may only occur in accordance with an exemption from SFAR No. 119, § 91.1619. A petition for exemption must comply with 14 CFR part 11. The FAA will consider whether exceptional circumstances exist beyond those described in the approval process in the previous section. To determine whether a petition for exemption from the prohibition this SFAR establishes fulfills the standards described in 14 CFR 11.81, the FAA consistently finds necessary the following information:
• The proposed operation(s), including the nature of the operation;
• The service the person(s) covered by the SFAR will provide;
• The specific locations in the Kabul FIR (OAKX) where the proposed operation(s) will occur, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the Kabul FIR (OAKX) and the airports, airfields, or landing zones at which the aircraft will take off and land;
• The method by which the operator will obtain current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations (
• The plans and procedures the operator will use to minimize the risks identified in this preamble to the proposed operations, to support the relief sought, and demonstrate that granting such relief would not adversely affect safety or would provide a level of safety at least equal to that provided by this SFAR. The FAA has found comprehensive, organized plans and procedures of this nature to be helpful in facilitating the agency's safety evaluation of petitions for exemption from flight prohibition SFARs.
The FAA includes, as a condition of each such exemption it issues, a release and agreement to indemnify, as described previously.
The FAA recognizes that, with the support of the U.S. Government, the governments of other countries could plan operations that may be affected by SFAR No. 119, § 91.1619. While the FAA will not permit these operations through the approval process, the FAA will consider exemption requests for such operations on an expedited basis and in accordance with the order of preference set forth in paragraph (c) of SFAR No. 119, § 91.1619.
If a petition for exemption includes information that is sensitive for security reasons or proprietary information, requestors may contact the Washington Operations Center for instructions on submitting it to the FAA. The Washington Operations Center's contact information is listed in the
Congress authorized the FAA by statute to promote safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures the Administrator finds necessary for safety in air commerce and national security. 49 U.S.C. 44701. Consistent with that mandate, the FAA is prohibiting certain persons from conducting flight operations in the Kabul FIR (OAKX) below certain altitudes due to the continuing hazards to the safety of U.S. civil flight operations at those altitudes. The purpose of this rule is to operate holistically in addressing a range of hazards and needs in the Kabul FIR (OAKX). However, the FAA recognizes that certain provisions focus on unique factors. Therefore, the FAA finds that the various provisions of this final rule are severable and able to operate functionally if severed from each other. In the event a court were to invalidate one or more of this final rule's unique provisions, the remaining provisions should stand, thus allowing the FAA to continue to fulfill its Congressionally authorized role of promoting safe flight of civil aircraft in air commerce.
Federal agencies consider impacts of regulatory actions under a variety of Executive orders and other requirements. First, Executive Orders 12866 and 13563, as amended by Executive Order 14094 (“Modernizing Regulatory Review”), direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603
In conducting these analyses, the FAA has determined this final rule has benefits that justify its costs. This rule is a significant regulatory action, as defined in section 3(f)(4) of Executive Order 12866 as amended by Executive Order 14094. As 5 U.S.C. 553 does not require notice and comment for this final rule, 5 U.S.C. 603 and 604 do not require regulatory flexibility analyses regarding impacts on small entities. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or Tribal governments, or on the private sector, by exceeding the threshold identified previously.
This rule continues to prohibit U.S. civil flights in the Kabul FIR (OAKX) at altitudes below FL320, except for transiting overflights on jet routes P500-G500, due to the significant hazards to U.S. civil aviation described in this preamble. The alternative flight routes result in some additional fuel and operations costs to the affected operators, as well as some costs attributed to passenger time. However, this amendment of the SFAR provides relief to U.S. civil operators and airmen wishing to conduct transiting overflight operations on jet routes P500-G500 at altitudes at and above FL300, instead of requiring them to operate at altitudes at and above FL320, as the SFAR previously did.
For the reasons described in the Background and Discussion of the Final Rule section of this preamble, the FAA has determined that U.S. civil aviation overflights of the Kabul FIR (OAKX) at altitudes at and above FL300 on jet routes P500-G500 present a low risk and that U.S. operators and airmen may conduct such flights. However, as described in more detail in the Background and Discussion of the Final Rule section of this preamble, the FAA has also determined that U.S. civil aviation operations in the remainder of the Kabul FIR (OAKX) at altitudes below FL320 continue to pose unacceptable risks to the safety of U.S. civil aviation due to the risks to such operations posed by violent extremist and militant activity and the lack of adequate risk mitigation capabilities to counter such activity. The rule allows for a lower minimum flight level of FL300 on jet routes P500-G500, providing relief and reducing the cost for overflights transiting P500-G500 while continuing to prohibit unsafe flights in the remainder of the Kabul FIR (OAKX) at altitudes below FL320.
The Regulatory Flexibility Act (RFA), in 5 U.S.C. 603, requires an agency to prepare an initial regulatory flexibility analysis describing impacts on small entities whenever 5 U.S.C. 553 or any other law requires an agency to publish a general notice of proposed rulemaking for any proposed rule. Similarly, 5 U.S.C. 604 requires an agency to prepare a final regulatory flexibility analysis when an agency issues a final rule under 5 U.S.C. 553 after that section or any other law requires publication of a general notice of proposed rulemaking. The FAA concludes good cause exists to forgo notice and comment and to not delay the effective date for this rule. As 5 U.S.C. 553 does not require notice and comment in this situation, 5 U.S.C. 603 and 604 similarly do not require regulatory flexibility analyses.
The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where
The FAA has assessed the potential effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from risks to their operations in the Kabul FIR (OAKX), a location outside the U.S. Therefore, the rule complies with the Trade Agreements Act of 1979.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and Tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $183 million in lieu of $100 million.
This final rule does not contain such a mandate. Therefore, the requirements of title II of the Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires the FAA to consider the impact of paperwork and other information collection burdens it imposes on the public. The FAA has determined no new requirement for information collection is associated with this final rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, the FAA's policy is to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined no ICAO Standards and Recommended Practices correspond to this regulation. The FAA finds this action is fully consistent with the obligations under 49 U.S.C. 40105(b)(1)(A) to ensure the FAA exercises its duties consistently with the obligations of the United States under international agreements.
While the FAA's flight prohibition does not apply to foreign air carriers, DOT codeshare authorizations prohibit foreign air carriers from carrying a U.S. codeshare partner's code on a flight segment that operates in airspace for which the FAA has issued a flight prohibition for U.S. civil aviation. In addition, foreign air carriers and other foreign operators may choose to avoid, or be advised or directed by their civil aviation authorities to avoid, airspace for which the FAA has issued a flight prohibition for U.S. civil aviation.
The FAA has analyzed this action under Executive Order 12114, Environmental Effects Abroad of Major Federal Actions, and DOT Order 5610.1C, Paragraph 16. Executive Order 12114 requires the FAA to be informed of environmental considerations and take those considerations into account when making decisions on major Federal actions that could have environmental impacts anywhere beyond the borders of the United States. The FAA has determined this action is exempt pursuant to section 2-5(a)(i) of Executive Order 12114 because it does not have the potential for a significant effect on the environment outside the United States.
In accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 8-6(c), the FAA has prepared a memorandum for the record stating the reason(s) for this determination and has placed it in the docket for this rulemaking.
The FAA has analyzed this rule under the principles and criteria of Executive Order 13132. The agency has determined this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, this rule will not have federalism implications.
The FAA analyzed this rule under Executive Order 13211. The agency has determined it is not a “significant energy action” under the Executive order and will not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609 promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609 and has determined that this action will have no effect on international regulatory cooperation.
Except for classified and controlled unclassified material not authorized for public release, all documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the internet through the docket for this rulemaking.
Those documents may be viewed online at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677.
The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121) (set forth as a note to 5 U.S.C. 601) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official or the persons listed under the
Afghanistan, Air traffic control, Aircraft, Airmen, Airports, Aviation safety, Freight.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations, as follows:
49 U.S.C. 106(f), 106(g), 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, Pub. L. 114-190, 130 Stat. 615 (49 U.S.C. 44703 note); articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11).
(c)
(1)
(ii) Transiting overflights of the Kabul Flight Information Region (FIR) (OAKX) may be conducted on jet routes P500-G500 at altitudes at and above FL300, subject to the approval of, and in accordance with the conditions established by, the appropriate authorities of Afghanistan.
(2)
Issued in Washington, DC, under the authority of 49 U.S.C. 106(f) and (g), 40101(d)(1), 40105(b)(1)(A), and 44701(a)(5).
Internal Revenue Service (IRS), Treasury.
Final rule.
This document contains final regulations relating to the excise tax imposed on certain sales by manufacturers, producers, or importers of designated drugs. Specifically, the final regulations set forth procedural provisions relating to how taxpayers must report liability for such tax. The final regulations also except such tax from semimonthly deposit requirements. The final regulations affect manufacturers, producers, or importers of designated drugs dispensed, furnished, or administered to individuals under the terms of Medicare during certain statutory periods.
Jacob W. Peeples or James S. Williford at (202) 317-6855 (not a toll-free number).
This document amends the Excise Tax Procedural Regulations (26 CFR part 40) and adds new part 47 to 26 CFR chapter I to contain the “Designated Drugs Excise Tax Regulations” related to the excise tax imposed by section 5000D of the Internal Revenue Code (Code) on certain sales by manufacturers, producers, or importers of designated drugs (section 5000D tax).
Sections 1191 through 1198 of the Social Security Act (SSA), added by sections 11001 and 11002 of Public Law 117-169, 136 Stat. 1818 (August 16, 2022), commonly referred to as the Inflation Reduction Act of 2022 (IRA), require the Secretary of Health and Human Services to establish a Medicare prescription drug price negotiation program (Medicare Drug Price Negotiation Program) to negotiate maximum fair prices for certain high expenditure, single-source drugs covered under Medicare.
Section 5000D, added to new chapter 50A of the Code by section 11003 of the IRA, imposes an excise tax on certain sales by manufacturers, producers, or importers of designated drugs dispensed, furnished, or administered to individuals under the terms of Medicare during a day that falls within a period described in section 5000D(b). The periods described in section 5000D(b) relate to certain statutorily prescribed milestones in the Medicare Drug Price Negotiation Program. Because chapter 50A is a new chapter of the Code, the existing regulations that prescribe procedural rules applicable to most Federal excise taxes do not apply to chapter 50A.
Notice 2023-52 (2023-35 I.R.B. 650; August 28, 2023) announced that the Department of the Treasury (Treasury Department) and the IRS intended to propose regulations addressing substantive and procedural issues related to the section 5000D tax.
On October 2, 2023, a notice of proposed rulemaking (REG-115559-23) was published in the
As noted in the Background section of this preamble, the Treasury Department and the IRS received several public comment submissions in response to the proposed regulations. The public comments fall into six general categories: timing of the publication of the proposed regulations; the quarterly filing requirement in the proposed regulations; the proposed regulations'
All public comments were considered and are available at
A commenter stated that the Treasury Department and the IRS acted prematurely when publishing proposed regulations related to procedural rules prior to publishing substantive rules for the section 5000D tax and requested that the Treasury Department and the IRS withdraw the proposed regulations until substantive rules are published.
The section 5000D tax is a self-executing tax—that is, the section 5000D tax is effective and applicable regardless of whether implementing regulations are published by the Treasury Department and the IRS.
A commenter expressed concern regarding the proposed regulations' quarterly filing and payment requirement. Specifically, the commenter stated that—in the absence of substantive guidance such as clarification of what sales are subject to the section 5000D tax—it is “impossible” for the IRS to determine that a “quarterly cadence” for filing returns and paying the section 5000D tax is rational. Further, the commenter stated that the quarterly filing requirement will be overly burdensome on taxpayers.
Generally, § 40.6011(a)-1(a)(2)(i) requires that taxpayers subject to Federal excise tax must file a Form 720,
In developing the proposed regulations, the Treasury Department and the IRS recognized that in the context of the section 5000D tax (under which a taxpayer may incur liability in a particular calendar quarter and then never incur liability again in subsequent calendar quarters), to require a taxpayer to continue to file Form 720 for every calendar quarter following the filing of its first Form 720 even if no tax liability is incurred in subsequent calendar quarters would be both unnecessary for tax administration and unduly burdensome on the taxpayer. As a result, the proposed regulations exempted taxpayers that incur a section 5000D tax liability (section 5000D taxpayers) and report that tax liability on a timely filed Form 720 from the general requirement to file subsequent Forms 720 if no section 5000D tax liability is incurred during a subsequent calendar quarter. Specifically, proposed § 40.6011(a)-1(d) required a taxpayer to file a subsequent Form 720 only if a new section 5000D tax liability arises during a particular calendar quarter.
Regarding the requirement to pay a section 5000D tax liability quarterly with the taxpayer's Form 720, generally, §§ 40.6071(a)-1(a) and 40.6151(a)-1 require that Form 720 filers must pay the tax shown on the return at the same time the return is filed. Providing a different rule for section 5000D taxpayers would introduce unnecessary complexity into the excise tax filing and payment regime. An increase in complexity could lead to taxpayer confusion and likely result in a greater burden on both taxpayers and the IRS with little to no benefit accruing to stakeholders. The Treasury Department and the IRS also note that proposed § 40.6302(c)-1 exempted the section 5000D tax from the semimonthly deposit requirements that apply to most other Federal excise taxpayers. By finalizing this proposed rule without this modification to the requirement to pay with the quarterly filing, the compliance burden on section 5000D taxpayers will be further reduced.
For these reasons, as well as for reasons similar to those discussed in part II of this Summary of Comments and Explanation of Revisions (related to the necessity to timely provide section 5000D taxpayers with procedural guidance on how to meet their tax reporting and payment obligations), the Treasury Department and the IRS are finalizing the proposed regulations without adopting this comment.
The proposed regulations provided that the Treasury decision finalizing the proposed regulations will apply to calendar quarters beginning on or after October 1, 2023; in other words, the proposed regulations provided that this Treasury decision will not apply beginning on the date that it is published in the
As discussed in part II of this Summary of Comments and Explanation of Revisions, the Treasury Department and the IRS prioritized providing section 5000D taxpayers with procedural guidance on how to meet their tax reporting and payment obligations by October 2, 2023, the first date when a taxpayer could incur a section 5000D tax liability. Because the
Some commenters stated that the Medicare Drug Price Negotiation Program generally, and the section 5000D tax specifically, may be unconstitutional. These comments are outside the scope of the proposed regulations, which set forth proposed rules for administering a duly enacted tax law. Therefore, it is not appropriate for the Treasury Department and the IRS to address these comments in the context of this rulemaking.
A commenter requested that the Treasury Department and the IRS consider providing sales-reporting and calculation “safe harbors” in these final regulations. Another commenter stated their belief that Notice 2023-52 requested clarification on how the Treasury Department and the IRS should define “sales” for purposes of the section 5000D tax. These comments are outside the scope of the proposed regulations, which related only to the procedures for reporting and paying the section 5000D tax.
A commenter requested that the Treasury Department and the IRS reconsider the paperwork burden estimate in the Paperwork Reduction Act (44 U.S.C. 3507(d)) (PRA) section of the proposed regulations because the commenter believes that the number of estimated hours is too low. In this request, the commenter suggested that it is possible that no taxpayers will ever incur a section 5000D tax liability. The commenter accepted that the Treasury Department and the IRS do not have historical data on the number of compliance hours affected taxpayers may experience if a section 5000D tax liability is incurred and did not offer a specific estimated number of hours it views as more accurate than the estimate provided in the proposed regulations. Similarly, the commenter did not offer an alternative calculation methodology that the Treasury Department and the IRS could use to provide a better burden estimate.
The Treasury Department and the IRS calculated the estimated number of paperwork burden hours using the long-standing and established methodology outlined in Publication 5743,
A commenter requested that the Treasury Department and the IRS conduct a Regulatory Flexibility Act (5 U.S.C. chapter 6) (RFA) analysis because the commenter is concerned that this Treasury decision may have an indirect effect on small entities. An agency may properly certify that no RFA analysis is needed when it determines that a rule will not have a significant economic impact on a substantial number of small entities that are subject to the requirements of the proposed rule. See
Pursuant to the Memorandum of Agreement, Review of Treasury Regulations under Executive Order 12866 (June 9, 2023), tax regulatory actions issued by the IRS are not subject to the requirements of section 6 of Executive Order 12866, as amended. Therefore, a regulatory impact assessment is not required.
The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the PRA under control number 1545-0023.
The collections of information in these regulations relate to reporting and recordkeeping requirements that will allow taxpayers to meet their tax reporting obligations. The collections of information would generally be used by the IRS for tax compliance purposes and by taxpayers to facilitate proper tax reporting and compliance. The reporting and recordkeeping requirements are covered within the form and instructions for Form 720.
Because the section 5000D tax is a new tax that has never been reported to the IRS, the Treasury Department and the IRS do not have historical data on the number of affected taxpayers. The Centers for Medicare and Medicaid Services (CMS) has selected 10 drugs for price negotiation for initial price applicability year 2026. CMS will select for negotiation a limited number of drugs for each initial price applicability year after that, as outlined in the IRA. Further, manufacturers, producers, or importers of such drugs may or may not become subject to a section 5000D tax liability. Based on the foregoing, the IRS estimates that there will be between 0 and 50 taxpayers during the next 3 years.
If a taxpayer has a section 5000D tax liability, it would be required to file Form 720 to report such liability. Form 720 is a quarterly return. A taxpayer would only be required to file Form 720 during calendar quarters in which the taxpayer has a section 5000D tax liability. Therefore, a taxpayer that has a section 5000D tax liability in one calendar quarter but not in subsequent calendar quarters would only be required to file one Form 720.
The respondents with regard to the section 5000D tax are manufacturers, producers, or importers of certain drugs. The Treasury Department and the IRS estimate the annual burden of the collections of information as follows (these estimates, which are for PRA purposes only, are based on the high end of the range of possible taxpayers and the high end of the range of the frequency of responses, in which a taxpayer would have tax liability in all four calendar quarters):
A Federal agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number assigned by OMB. Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by section 6103.
The Treasury Department and the IRS received a comment suggesting that the paperwork burden estimate provided in the proposed regulations was too low. However, for the reasons discussed in detail in the Summary of Comments and Explanation of Revisions section of this preamble and in this Special Analyses section, the Treasury Department and the IRS have not changed the estimates provided herein.
For the reasons discussed in detail in the Summary of Comments and Explanation of Revisions section of this preamble and in this Special Analyses section, pursuant to the RFA, it is hereby certified that these final regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that the section 5000D tax is imposed only on certain sales by manufacturers, producers, or importers of designated drugs during periods described in section 5000D(b). The periods described in section 5000D(b) relate to milestones in the Medicare Drug Price Negotiation Program, which involve only certain drugs with high Medicare expenditures. Drugs with high Medicare expenditures that are not already excluded from the Medicare Drug Price Negotiation Program under an exception such as the SSA's small biotech exception (sections 1192(b) and (d)(2) of the SSA) are likely to be manufactured, produced, or imported by large entities, so if any section 5000D tax liability arises, an insubstantial number of taxpayers will be small entities. As noted earlier, data is not available about the number of taxpayers affected, but the number is likely to be limited, in part due to the limited number of drugs selected for the Medicare Drug Price Negotiation Program in any particular year. In addition, these final regulations will assist taxpayers in meeting their tax reporting obligations by providing clarity on how to report section 5000D tax liability, which will make it easier for taxpayers to comply with section 5000D. Therefore, these final regulations will not create additional obligations for, or impose a significant economic impact on, small entities, and a regulatory flexibility analysis under the RFA is not required.
Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these final regulations was submitted to the Chief Counsel for the Office of Advocacy of the Small Business Administration for comment on its impact on small business. No comments were received from the Chief Counsel for the Office of Advocacy of the Small Business Administration.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. These final regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments, or by the private sector, in excess of that threshold.
Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and local governments, and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These final regulations do not have federalism implications, do not impose substantial direct compliance costs on State and local governments, and do not preempt State law within the meaning of the Executive order.
The IRS Notice cited in this preamble is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at
The principal author of these regulations is Jacob W. Peeples of the Office of the Associate Chief Counsel (Passthroughs & Special Industries). However, other personnel from the Treasury Department and the IRS participated in their development.
Excise taxes, Reporting and recordkeeping requirements.
Excise taxes.
Accordingly, the Treasury Department and the IRS amend 26 CFR chapter I, subchapter D, as follows:
26 U.S.C. 7805.
(a)
(e)
(2)
(3)
The revision and additions read as follows:
(a) * * *
(2) * * *
(i) * * * Except as provided in paragraphs (b) through (d) of this section, the return must be made for a period of one calendar quarter. * * *
(d)
(e)
(2)
(3)
The revisions and addition read as follows:
(e) * * *
(1) * * *
(iv) Sections 4375 and 4376 (relating to fees on health insurance policies and self-insured insurance plans);
(v) Section 5000B (relating to indoor tanning services); and
(vi) Section 5000D (relating to the sale of designated drugs).
(f)
(2)
26 U.S.C. 7805.
Section 47.5000D-1 also issued under 26 U.S.C. 5000D.
This section lists the table of contents for §§ 47.5000D-1 through 47.5000D-4.
(a) In general.
(b) Applicability date.
(a)
(b)
Department of Justice.
Final rule.
This rule sets forth a process by which the Attorney General or a designee may determine that an individual shall not be deemed an employee of the Public Health Service for purposes of medical malpractice coverage under the Public Health Service Act. The process described in this rule applies to individuals who are deemed to be Public Health Service employees, as well as any other individuals deemed to be Public Health Service employees under different statutory provisions to which the procedures set out in the Public Health Service Act have been made applicable.
This rule is effective on August 5, 2024.
James G. Touhey, Jr., Director, Torts Branch, Civil Division, Department of Justice, Washington, DC 20530, (202) 616-4400.
This rule finalizes, with some changes, a proposed rule that the Department of Justice (“Department”) published on this subject on March 6, 2015, at 80 FR 12104. In brief, the following changes were made to the text of the proposed rule:
In § 15.11, a sentence was added to clarify that an individual who is no longer “deemed” to be an employee of the Public Health Service pursuant to section 224(i) of the Public Health Service Act, 42 U.S.C. 233(i), is excluded from medical malpractice protections otherwise available to individuals “deemed” to be Public Health Service employees under the
In § 15.12, the definition of “Attorney General” for purposes of the rule was deleted as vague and unnecessary in light of the more specifically defined roles and responsibilities of the initiating official, the adjudicating official, and the administrative law judge involved in proceedings under this subpart.
In § 15.13, a change was made to clarify that the initiating official's notice to an individual is intended to comply with the Administrative Procedure Act (“APA”), 5 U.S.C. 551,
In § 15.14, a change was made to clarify that the administrative law judge assigned to conduct a hearing under this subpart must, consistent with the APA, conduct proceedings in an impartial manner. In addition, § 15.14 now incorporates the grounds and procedure for seeking disqualification of an administrative law judge set forth in 5 U.S.C. 556(b).
In §§ 15.16 and 15.20, a change was made to clarify that the administrative law judge, consistent with the APA, must certify the record to the adjudicating official for a final determination.
A change was made to § 15.17 to clarify that the adjudicating official will consult with the Secretary of Health and Human Services (“Secretary”) in making a final determination. A subsection (d) was added to clarify that the Attorney General, consistent with the traditional authority of agency heads, possesses discretion to review any final determination within 30 days of its issuance.
In addition, minor clarifications were made to § 15.19 to make clear that final determinations, whether upholding or rejecting the initiating official's proposed action, will be distributed to the parties in the same way.
Changes were also made to the reinstatement procedures in § 15.20. Petitions for reinstatement must be submitted to the initiating official, who is responsible for forwarding the petition, along with a recommendation on whether the petition makes a prima facie case for reinstatement, to the adjudicating official. The adjudicating official is responsible for determining whether a prima facie case for reinstatement has been made. If the adjudicating official determines that a prima facie case has been made for reinstatement, an administrative law judge is appointed to conduct such proceedings as are deemed necessary to make a formal recommendation to the adjudicating official. This procedure was revised to avoid having the initiating official—who might be viewed as the adverse party in an original proceeding to de-deem an individual—exercise an unfettered gatekeeping role in determining whether that same individual's petition for reinstatement should receive a hearing.
Finally, the Department notes that since the date of publication of the proposed rule on March 6, 2015, the Supreme Court held in
The Federally Supported Health Centers Assistance Acts of 1992 (Pub. L. 102-501) (“FSHCAA”) and 1995 (Pub. L. 104-73) amended section 224 of the Public Health Service Act (42 U.S.C. 233) to make the Federal Tort Claims Act (“FTCA”) (28 U.S.C. 1346(b), 2672) the exclusive remedy for medical malpractice claims for personal injury or death brought against qualifying federally supported health centers and certain statutorily identified categories of individuals, to the extent that the centers and these individuals, as the case may be, have been “deemed” by the Department of Health and Human Services to be eligible for FTCA coverage and the conditions for such coverage have been satisfied. 42 U.S.C. 233(g).
In 1996, the Health Insurance Portability and Accountability Act (Pub. L. 104-191) amended section 224 of the Public Health Service Act to provide that, subject to certain conditions, a “free clinic health professional” providing “a qualifying health service” for the free clinic may be “deemed” to be a Public Health Service employee eligible for FTCA coverage to the same extent as persons “deemed” to be Public Health Service employees under 42 U.S.C. 233(g). In 2010, the Patient Protection and Affordable Care Act (Pub. L. 111-148) further amended section 224 of the Public Health Service Act to add “an officer, governing board member, employee, or contractor of a free clinic . . . in providing services for the free clinic” to the statutorily identified categories of eligible individuals for this purpose. 42 U.S.C. 233(o)(1).
And in 2016, the 21st Century Cures Act (Pub. L. 114-225) amended section 224 of the Public Health Service Act to provide that, subject to certain conditions, a “health professional volunteer” at an entity “deemed” to be a Public Health Service employee by virtue of 42 U.S.C. 233(g) may be “deemed” to be a Public Health Service employee eligible for FTCA coverage to the same extent as persons “deemed” to be Public Health Service employees under 42 U.S.C. 233(g). 42 U.S.C. 233(q).
This rule will apply to any individual “deemed” to be a Public Health Service employee, regardless of the statutory provision under which the deemed status is obtained, provided that Congress has made the individual's “deemed” Public Health Service employee status subject to the procedures set out in 42 U.S.C. 233(i).
Section 233(i) of title 42 provides that the Attorney General, in consultation with the Secretary, may, on the record, determine, after notice and an opportunity for a full and fair hearing, that an individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of an entity described in 42 U.S.C. 233(g)(4) shall not be deemed to be an employee of the Public Health Service for purposes of 42 U.S.C. 233 if “treating such individual as such an employee would expose the Government to an unreasonably high degree of risk of loss” based on one or more of the following enumerated statutory criteria: (1) the individual does not comply with the policies and procedures that the entity has implemented pursuant to 42 U.S.C. 233(h)(1); (2) the individual has a history of claims filed against him or her as provided for under 42 U.S.C. 233 that is outside the norm for licensed or certified health care practitioners within the same specialty; (3) the individual refused to reasonably cooperate with the Attorney General in defending against any such claim; (4) the individual provided false information relevant to the individual's performance of his or her duties to the Secretary, the Attorney General, or an applicant for or recipient
A final determination by the Attorney General under 42 U.S.C. 233(i) that an individual physician or other licensed or certified health care professional shall not be deemed to be an employee of the Public Health Service is effective when the entity employing such individual receives notice of such determination, and the determination applies only to acts or omissions occurring after the date such notice is received. 42 U.S.C. 233(i)(2).
This rule establishes a process for creating the record and providing the full and fair hearing before the Attorney General makes a final determination under 42 U.S.C. 233(i).
The first step, pursuant to § 15.13(a), is a finding by the “initiating official,” in consultation with the Secretary, that treating an individual as an employee of the Public Health Service may expose the Government to an unreasonably high degree of risk of loss for one or more of the statutorily enumerated reasons in 42 U.S.C. 233(i). Under § 15.12(d), the initiating official is a Deputy Assistant Attorney General of the Department of Justice's Civil Division or a designee of a Deputy Assistant Attorney General.
Section 15.13(a) requires the initiating official to provide notice to the individual in question that an administrative hearing will be held to determine whether treating the individual as an employee of the Public Health Service would expose the Government to an unreasonably high degree of risk of loss based upon one or more of the statutory criteria enumerated in 42 U.S.C. 233(i). Following a period for discovery and depositions, to the extent determined appropriate by an administrative law judge under § 15.15, the hearing is then conducted by the administrative law judge in the manner prescribed in § 15.14. After the hearing is conducted and the record is closed, § 15.16 requires the administrative law judge to certify the record and submit written findings of fact, conclusions of law, and a recommended decision to the “adjudicating official,” who is the Assistant Attorney General for the Department of Justice's Civil Division or a designee of the Assistant Attorney General. Section 15.16 provides that copies of the findings of fact, conclusions of law, and recommended decision are made available to the parties and to the Secretary. Section 15.17(b) then gives the parties 30 days to submit certain additional materials, including exceptions to the administrative law judge's recommended decision, to the adjudicating official, who then must, in consultation with the Secretary, make a final determination whether treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would expose the Government to an unreasonably high degree of risk of loss based on one or more of the criteria specified in 42 U.S.C. 233(i). The Attorney General may exercise discretion to review any final determination within 30 days of its issuance.
Section 15.18 provides that an individual who is dissatisfied with the final determination may seek rehearing within 30 days after notice of the determination is sent, and § 15.20 allows individuals who have been determined to expose the United States to an unreasonably high degree of risk of loss to apply for reinstatement after a period of time. Consistent with 42 U.S.C. 1320a-7e(a) and 45 CFR 60.3, 60.5(h) and 60.16, the rule also provides that the Department will notify the National Practitioner Data Bank (“NPDB”) of the issuance of the Attorney General's final determination that an individual provider shall not be deemed to be an employee of the Public Health Service under this rule. The NPDB, which is maintained by the Health Resources and Services Administration within the Department of Health and Human Services, is a confidential information clearinghouse created by Congress with primary goals of improving health care quality and protecting the public.
The Department received ten public comments on the proposed rule during the comment period, which closed on May 6, 2015. Several commenters generally supported the proposed rule as providing adequate notice and process to reach fair decisions on whether to de-deem individual practitioners who pose an unreasonably high degree of risk of loss to the Government. The Department is grateful for the feedback.
Several comments were received from membership organizations of federally supported health centers that receive Federal grant money under 42 U.S.C. 254b, as well as one federally supported health center that offered comments on its own behalf. These comments generally sought additional guidance on how the rules and criteria set forth in 42 U.S.C. 233(i)(1) would be applied. A few other commenters expressed more general concerns about the consequences of de-deeming determinations. Summaries of these comments and the Department's responses to them are set forth below.
1. Some commenters requested that the Department provide additional guidance on how the statutory criteria for determining whether treating an individual physician or certified health care provider as a Public Health Service employee exposes the Government to an “unreasonably high degree of risk of loss” will be applied. These commenters requested that clearer definitions be adopted and that specific examples be provided for how each of the criteria set forth in 42 U.S.C. 233(i)(A)-(E) will be weighed and considered.
Section 233(i) requires a full and fair hearing to determine whether any one of these factors or combination of factors supports a determination that treating an individual physician or certified health care provider as a Public Health Service employee poses an “unreasonably high degree of risk of loss” to the Government.
The commenters recognized that “strict definitions” for these criteria would be impracticable. The Department agrees with the commenters. In addition to the impracticality of adopting strict definitions, the Department also observes that the application of the criteria set forth in the statute will necessarily depend on the specific facts and circumstances of each individual case.
2. Some commenters requested that the Department expand the scope of the regulations to specify the form and substance of the consultation that the Attorney General undertakes with the Secretary before finding that an individual should be provided notice of a hearing to determine whether treating
3. Some commenters requested that the Department, when notifying an individual that a proceeding has been initiated under 42 U.S.C. 233(i), be required to provide both the specific information upon which the Department will rely and the standards that will apply for evaluating the criteria set forth in 42 U.S.C. 233(i). The commenters suggested that providing such information in the hearing notice would reduce discovery costs and increase efficiency of the hearing process.
4. One commenter requested that the Department state the period of time after which a de-deemed practitioner may apply for reinstatement.
5. One commenter requested that the Department clarify the events and informational exchanges that will or could set into the motion the de-deeming process.
6. A few commenters expressed concern that the de-deeming process could be initiated to rescind FTCA coverage while a lawsuit was pending and requested that the rule allow only for prospective de-deeming. Another commenter suggested adoption of a “safety period”—a designated period of time during which a “deemed” employee cannot be subject to “de-deeming”—that would apply where litigation is anticipated involving acts or omissions of a practitioner who has been deemed to be an employee of the Public Health Service.
7. One commenter expressed concern that the proposed rule might have untoward consequences, such as difficulty in securing quality replacement personnel or loss of liability coverage while a lawsuit is pending.
The Attorney General's de-deeming determination does not require or compel a health center to terminate a practitioner. Entities may choose to employ “de-deemed” practitioners, but they can no longer rely on the protections of 42 U.S.C. 233(g) or similar statutes, as the case may be, as a substitute for medical malpractice liability coverage for that practitioner if that practitioner is subject to a medical malpractice claim for acts or omissions occurring after receipt of a final de-deeming determination, for so long as the final determination remains effective. Congress's decision to authorize the Attorney General to de-deem individual practitioners reflects a policy judgment that, if an individual practitioner exposes the Government to an unreasonably high degree of risk of loss based on any of the statutory criteria enumerated in 42 U.S.C. 233(i), insuring against that risk or finding a suitable replacement should fall upon the entity responsible for hiring and retaining the practitioners or the sponsoring free clinic, not the United States. Qualifying health centers that receive Federal grants pursuant to 42 U.S.C. 254b may purchase “tail,” “gap,” or “wrap-around” insurance to cover claims for which liability protections under 42 U.S.C. 233(g) or similar
8. One commenter expressed concern that final determinations are vested in the Attorney General or the Attorney General's designee and suggested that the recommendations of the presiding administrative law judge be binding or that three-judge panels be established for purposes of making final determinations.
The Attorney General, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this final rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities because it pertains to personnel and administrative matters affecting the Department. This rule merely sets forth the process for a hearing used to determine whether certain individual health care providers should no longer be “deemed” to be “employees of the Public Health Service,” thus excluding such individual health care providers from eligibility for the medical malpractice liability protections under 42 U.S.C. 233(g), (o), or (q). The rule does not adopt substantive standards and therefore will not have a significant impact on regulated parties.
This final rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” Executive Order 13563, “Improving Regulation and Regulatory Review,” and Executive Order 14094, “Modernizing Regulatory Review.” The Office of Management and Budget has determined that this final rule is a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this final rule has been reviewed by the Office of Management and Budget. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
The Department has assessed the costs and benefits of this final rule and believes that its benefits justify its costs.
As an initial matter, this final rule only establishes a process for removing a statutorily conferred deemed status applicable to an individual provider who is determined to expose the Government to an unreasonably high degree of risk of loss for one or more statutorily enumerated reasons. As further explained below, Congress expressly granted the Attorney General the authority to de-deem certain individual physicians or other licensed or certified health care practitioners, provided that certain procedural safeguards were in place. This rule establishes those safeguards. The process will impose some costs on both the government and the individuals who are subject to proceedings under 42 U.S.C. 233(i). But the net benefit is to reduce the potential for incorrect de-deeming decisions, to ensure that a de-deeming decision is based upon a developed record, and to provide the individual provider an opportunity to participate in the process. On balance, the Department believes these benefits outweigh the costs and will contribute to just decisions.
Congress expressly provided the Attorney General with the authority to exclude individuals who expose the Government to an unreasonably high degree of risk of loss based upon one or more statutory criteria from the malpractice protections afforded under 42 U.S.C. 233(g) and similar statutes. A statutory provision granting the Attorney General authority to exclude an individual provider has existed since the FSHCAA was first enacted in 1992. This provision was specifically designed to “assure that FTCA coverage is not extended to individual practitioners that do not provide care of acceptable quality” when the Attorney General determines that such individuals “expose the U.S. to an unreasonably high degree of risk of loss.” H.R. Rep. No. 102-823, pt. 2, at 8 (1992).
When the FSHCAA was amended and extended in 1995, Congress continued to include the provision authorizing the Attorney General to exclude an individual provider, adding language to clarify that an individual provider's “coverage” under the FSHCAA would be removed only after receiving notice and an opportunity for a full and fair hearing, with all decisions to be made “on the record.” H.R. Rep. No. 104-398, at 13 (1995); Public Law 104-73, sec. 9, 109 Stat. 777, 781 (1995).
In light of the foregoing, this final rule assures the procedural protections Congress intended, without altering Congress's objective that certain individual providers be subject to exclusion from the malpractice liability protections under 42 U.S.C. 233 if they expose the Government to an unreasonably high degree of risk of loss based on the enumerated statutory criteria. Congress already has established that the benefits of excluding certain providers outweigh the costs if procedural protections are afforded and the final decision is supported by one or more of the criteria specified in 42 U.S.C. 233(i).
The Department does not expect that the process created by the final rule will have systemic or large-scale costs because it is only the rare individual provider who would be subject to the procedures under this rule based on the statutory criteria of 42 U.S.C. 233(i); proceedings against an individual provider under this rule are expected to be infrequent and will, therefore, affect only a small fraction of providers, health centers, or, potentially, their patients.
The majority of costs associated with the final rule, then, would come in the individual instances of its application, which are not feasible to predict. The
While it is not feasible to estimate these costs with precision, the Department notes that the litigation costs incurred in defending medical malpractice suits in court frequently exceed $100,000 per case. The potential costs associated with a section 233(i) proceeding, by contrast, are expected to be a small fraction of the cost of litigating malpractice actions brought against individual providers. If even one provider is excluded from malpractice protections under 42 U.S.C. 233(g) or similar statutes, potentially resulting in at least one fewer malpractice action that the United States otherwise might have been required to defend, the potential cost savings to the United States will be tens of thousands of dollars on litigation expenses alone.
The Department also observes that losses in covered medical malpractice actions against deemed centers and their personnel are borne by the public fisc through the payment of judgments and settlements and other expenses. Each year, the Department transmits to the Secretary and Congress an estimate of the dollar amount of claims and litigation for which payments are expected to be made during the upcoming fiscal year, along with related fees and expenses. Although in 1996, it was estimated that only 14,234 individual providers were deemed to be Public Health Service employees for purposes of malpractice claims, that number has steadily risen, reaching in excess of 250,000 “deemed” providers as of April 2022.
In addition to the increasing numbers of providers eligible for malpractice protections under 42 U.S.C. 233(g) and similar statutes, the amount of money paid by the United States as a result of judgments and settlements and litigation expenses has steadily increased as well. Since fiscal year 2014, the average annual amount sought by claimants in malpractice losses against deemed providers has been approximately $35 billion. To be sure, the United States pays substantially less than the amount claimed in the majority of cases, but it still paid in excess of $100 million in fiscal years 2017, 2018, and 2019, respectively, including a then-record amount of $135,047,091 in 2019 alone. Fiscal years 2020 and 2021 saw a slight downturn in the number of claims paid, likely the result of delays in court proceedings during the COVID-19 pandemic and related restrictions. In fiscal year 2022, with restrictions largely lifted, the United States paid $158,338,182.79 in judgments and settlements, a new record amount.
Neither the criteria set forth in 42 U.S.C. 233(i) nor the final rule contemplates that an individual provider subjects the Government to an unreasonably high degree of risk of loss merely by subjecting the United States to suit on malpractice claims that result in losses. That is a potential basis for de-deeming only to the extent that a single provider's care has resulted in claims outside the norm for a licensed or certified practitioner in the same specialty. If a single provider, for example, exposed the United States to several meritorious claims, each costing the United States $1 million, and that provider's history of claims was outside the norm for a practitioner in the same specialty, then excluding that provider from the malpractice liability protections of 42 U.S.C. 233(g) or another statute, as the case may be, may result in substantial savings to the United States in the future. That is because de-deeming the provider will reduce the number of claims and the amount of losses the United States would otherwise have incurred as a result of that provider's care and treatment.
The Department further notes that, unlike with actual Federal employees, over whom Federal agencies exercise plenary control and have various means of addressing risk through disciplinary action or termination, individual providers deemed to be Public Health Service employees for purposes of covered malpractice claims remain under the exclusive control and supervision of the public or non-profit private entity that employs them. The Government has no role in the day-to-day operations of health centers or free clinics and no involvement in the employment or disciplinary decisions of such entities.
The Attorney General's authority to exclude an individual provider who poses an unreasonably high degree of risk of loss through a section 233(i) proceeding provides the United States some small measure of risk control. Moreover, the authority granted to the Attorney General under section 233(i) is, in practice, no different from the authority that a private insurance carrier could exercise to refuse to insure an individual provider who poses an unreasonably high degree of risk of loss. A section 233(i) proceeding to exclude an individual provider from coverage under 42 U.S.C. 233(g) or similar statutes, if it is determined that the individual provider poses an unreasonably high degree or risk of loss, is similar to the ability that a private insurer possesses to exclude from coverage individual providers for the same reasons.
In the event that treating an individual provider as a Public Health Service employee is ultimately determined to expose the United States to an unreasonably high degree of risk of loss, the Department acknowledges that there will be certain costs to that provider. An individual provider who is no longer deemed to be an employee of the Public Health Service for purposes of malpractice claims may, for example, be required to obtain personal medical malpractice insurance to continue practicing. The provider may also experience negative employment consequences as a result of the Attorney General's determination.
For several reasons, it is not feasible to estimate the costs to specific, individual providers of having to procure malpractice insurance in lieu of relying on deemed Public Health Service employee status for malpractice protection. Malpractice insurance rates vary greatly depending on factors like specialty and location, insurance provider, loss history, coverage requirements, policy limits, and policy type.
For example, State-filed malpractice premiums, before applied insurer discounts, average between roughly $2,486 and $15,949 in Nebraska, but between roughly $10,560 and $161,942 in New York, with higher premiums for higher-risk specialties.
The Department further observes that, while premiums may vary by location or specialty, an individual provider subject to a proceeding governed by this rule could come from any location or specialty; the only factor common to a provider subject to a proceeding under this rule will be a threshold finding, triggering the process under this rule, that the provider may expose the United States to an unreasonably high degree of risk of loss. Any provider who is excluded from coverage by a final determination made under 42 U.S.C. 233(i) would merely be placed in the position that provider would have occupied but for the existence of these statutes—that of a provider who must procure personal insurance. If a provider turns out to be uninsurable in the private insurance market, that provider's inability to procure insurance merely underscores that the provider poses an unreasonably high degree of risk of loss. Congress conferred upon the Attorney General the authority to de-deem certain individuals in order to protect against such an unreasonably high risk of loss. 42 U.S.C. 233(i); H.R. Rep. No. 102-823, pt. 2, at 8 (1992).
The Department acknowledges as well that if an individual provider is no longer deemed to be an employee of the Public Health Service and leaves the practice, the health center or free clinic may incur costs to find a new provider. Replacing providers, however, may occur even absent this final rule establishing a process for de-deeming individual providers, and the costs to entities of filling positions may not be readily traceable to the process established by this final rule.
In any event, the Department expects that substantial benefits will justify any costs incurred in finding replacements, as any individual who is replaced after being excluded from coverage following a proceeding under this rule will be one who has been determined to create an unreasonably high degree of risk of loss on claims for malpractice. It is anticipated that, in the usual case, the individual's replacement will provide reduced risk of loss for the United States and better care for patients. While there may be instances in which an individual who presented such a risk of loss cannot be replaced, the Department believes that these costs are justified by the benefits of implementing this rule to carry out Congress's stated objectives. Congress enacted 42 U.S.C. 233(i) “to assure that FTCA coverage is not extended to individual practitioners that do not provide care of acceptable quality” by providing a process whereby the Attorney General may exclude individuals based on a determination that such individuals “expose the U.S. to an unreasonably high degree of risk of loss.” H.R. Rep. No. 102-823, pt. 2, at 8 (1992). Implementing the process for section 233(i) proceedings through this final rule is a procedural step toward effectuating Congress's purpose in enacting section 233(i).
Based on the expectation that the process will be used sparingly and only for an individual provider who exposes the United States to an unreasonably high degree of risk of loss on medical malpractice claims for personal injury or death, the Department has concluded that the net benefits of improved patient care and reduced losses to the United States traceable to malpractice claims justify the potential costs of implementing a process to carry out 42 U.S.C. 233(i).
This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, the Department of Justice has determined that this final rule will not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This final rule meets the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988.
This final rule will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501
This final rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. This final rule will not result in an annual effect on the economy of $100 million or more; a major increase in cost or prices; significant adverse effects on competition, employment, investment, productivity, or innovation; or significant adverse effects on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
Claims, Government contracts, Government employees, Health care, Immunization, Nuclear energy.
For the reasons set forth in the preamble, the Attorney General amends part 15 of title 28 of the Code of Federal Regulations as follows:
5 U.S.C. 301, 554, 556, 557, and 8477(e)(4); 10 U.S.C. 1054, 1089; 22 U.S.C. 2702, 28 U.S.C. 509, 510, and 2679; 38 U.S.C. 7316; 42 U.S.C. 233, 2212, 2458a, and 5055(f); and sec. 2, Pub. L. 94-380, 90 Stat. 1113 (1976).
(a) The purpose of this subpart is to implement the notice and hearing
(b) Section 233(i) of title 42 provides that the Attorney General, in consultation with the Secretary of Health and Human Services, may on the record determine, after notice and an opportunity for a full and fair hearing, that an individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of an entity described in 42 U.S.C. 233(g)(4) shall not be deemed to be an employee of the Public Health Service for purposes of 42 U.S.C. 233 if treating such individual as such an employee would expose the Government to an unreasonably high degree of risk of loss.
As used in this subpart:
(1) The individual does not comply with the policies and procedures that the entity or the sponsoring free clinic has implemented pursuant to 42 U.S.C. 233(h)(1);
(2) The individual has a history of claims filed against him or her as provided for under 42 U.S.C. 233 that is outside the norm for licensed or certified health care practitioners within the same specialty;
(3) The individual refused to reasonably cooperate with the Attorney General in defending against any such claim;
(4) The individual provided false information relevant to the individual's performance of his or her duties to the Secretary, the Attorney General, or an applicant for or recipient of funds under title 42, chapter 6A, United States Code; or
(5) The individual was the subject of disciplinary action taken by a State medical licensing authority or a State or national professional society.
(a) Whenever the initiating official, in consultation with the Secretary, finds, based upon available information gathered or provided, that treating an individual as an employee of the Public Health Service may expose the Government to an unreasonably high degree of risk of loss, the initiating official shall notify the individual that an administrative hearing will be conducted for the purpose of determining whether treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would expose the United States to an unreasonably high degree of risk of loss.
(b) The notice of hearing shall be in writing and shall be sent by registered or certified mail to the individual at the individual's last known address, or to the individual's attorney in the event the Attorney General has received written notice that the individual has retained counsel.
(c) The notice shall contain:
(1) A statement of the nature and purpose of the hearing;
(2) The factual allegations and, where appropriate, the law asserted in support of the proposed action;
(3) The name of the administrative law judge;
(4) A statement of the nature of the action proposed to be taken; and
(5) A statement of the time, date, and location of the hearing.
(d) The hearing shall be initiated not sooner than 60 days of the date on the written notice of hearing.
(a) An administrative law judge appointed in accordance with 5 U.S.C. 3105 shall preside over the hearing.
(b) Pursuant to 5 U.S.C. 556(b), the administrative law judge is to conduct all proceedings in an impartial manner. The administrative law judge may disqualify himself at any time. An individual may move to disqualify the appointed administrative law judge only upon the filing, in good faith, of a timely and sufficient affidavit of personal bias or other ground for disqualification of the administrative law judge, such as conflict of interest or financial interest. If such affidavit is timely filed, the adjudicating official shall determine the matter as part of the record and final determination in the case.
(c) The administrative law judge shall have the following powers:
(1) Administer oaths and affirmations;
(2) Issue subpoenas authorized by law;
(3) Rule on offers of proof and receive relevant evidence;
(4) Take depositions or have depositions taken when the ends of justice would be served;
(5) Regulate the course of the hearing;
(6) Hold conferences for the settlement or simplification of the issues by consent of the parties or by the use of alternative means of dispute resolution;
(7) Inform the parties as to the availability of one or more alternative means of dispute resolution, and encourage use of such methods;
(8) Dispose of procedural requests or similar matters;
(9) Make or recommend decisions;
(10) Require and, in the discretion of the administrative law judge, adopt proposed findings of fact, conclusions of law, and orders;
(11) Take any other action that administrative law judges are authorized by statute to take; and
(12) All powers and duties reasonably necessary to perform the functions enumerated in paragraphs (c)(1) through (11) of this section.
(d) The administrative law judge may call upon the parties to consider:
(1) Simplification or clarification of the issues;
(2) Stipulations, admissions, agreements on documents, or other understandings that will expedite conduct of the hearing;
(3) Limitation of the number of witnesses and of cumulative evidence; and
(4) Such other matters as may aid in the disposition of the case.
(e) At the discretion of the administrative law judge, parties or witnesses may participate in hearings by video conference.
(f) All hearings under this subpart shall be public unless otherwise ordered by the administrative law judge.
(g) The hearing shall be conducted in conformity with 5 U.S.C. 554-557 (sections 5-8 of the Administrative Procedure Act).
(h) The initiating official shall have the burden of going forward with the evidence and shall generally present the Government's evidence first.
(i) Technical rules of evidence shall not apply to hearings conducted pursuant to this subpart, but rules designed to assure production of the most credible evidence available and to subject testimony to cross-examination shall be applied where reasonably necessary by the administrative law judge. The administrative law judge may exclude irrelevant, immaterial, or unduly repetitious evidence. All documents and other evidence offered or taken for the record shall be open to examination by the parties, and opportunity shall be given to refute facts and arguments advanced on either side of the issues. A transcript shall be made of the oral evidence except to the extent the substance thereof is stipulated for the record.
(j) During the time a proceeding is pending before an administrative law judge, all motions shall be addressed to the administrative law judge and, if within the administrative law judge's delegated authority, shall be ruled upon. Any motion upon which the administrative law judge has no authority to rule shall be certified to the adjudicating official with a recommendation. The opposing party may answer within such time as may be designated by the administrative law judge. The administrative law judge may permit further replies by both parties.
(a) At any time after the initiation of the proceeding, the administrative law judge may order, by subpoena if necessary, the taking of a deposition and the production of relevant documents by the deponent. Such order may be entered upon a showing that the deposition is necessary for discovery purposes and that such discovery could not be accomplished by voluntary methods. Such an order may also be entered in extraordinary circumstances to preserve relevant evidence upon a showing that there is substantial reason to believe that such evidence could not be presented through a witness at the hearing. The decisive factors for a determination under this subsection, however, shall be fairness to all parties and the requirements of due process. A deposition may be taken orally or upon written questions before any person who has the power to administer oaths and shall not exceed one day of seven hours.
(b) Each deponent shall be duly sworn, and any adverse party shall have the right to cross-examine. Objections to questions or documents shall be in short form, stating the grounds upon which objections are made. The questions propounded and the answers thereto, together with all objections made (but not including argument or debate), shall be reduced to writing and certified by the person before whom the deposition was taken. Thereafter, the person taking the deposition shall forward the deposition and one copy thereof to the party at whose instance the deposition was taken and shall forward one copy to the representative of the other party.
(c) A deposition may be admitted into evidence as against any party who was present or represented at the taking of the deposition, or who had due notice thereof, if the administrative law judge finds that there are sufficient reasons for admission and that the admission of the evidence would be fair to all parties and comport with the requirements of due process.
Within a reasonable time after the close of the record of the hearings conducted under § 15.14, the administrative law judge shall certify the record to the adjudicating official and shall submit to the adjudicating official written findings of fact, conclusions of law, and a recommended decision. The administrative law judge shall promptly make copies of the findings of fact, conclusions of law, and recommended decision available to the parties and the Secretary.
(a) In hearings conducted under § 15.14, the adjudicating official shall, subject to subsection (d), make the final determination on the basis of the certified record, findings, conclusions, and recommendations presented by the administrative law judge.
(b) Prior to making a final determination, the adjudicating official shall give the parties an opportunity to submit the following, within thirty days after the submission of the administrative law judge's recommendations:
(1) Proposed findings and determinations;
(2) Exceptions to the recommendations of the administrative law judge;
(3) Supporting reasons for the exceptions or proposed findings or determinations; and
(4) Final briefs summarizing the arguments presented at the hearing.
(c) The adjudicating official shall, within a reasonable time after receiving the parties' submissions, consult with the Secretary and then make a final determination. Copies of the final determination shall be served upon each party to the proceeding. Subject to paragraph (d) of this section, the final determination made by the adjudicating official under this rule shall constitute the final agency action.
(d) Within 30 days of any final determination made by the adjudicating official, the Attorney General may exercise discretion to review the final determination. In the event the Attorney General exercises discretion to review a decision, the Attorney General's final determination shall constitute the final agency action.
(a) An individual dissatisfied with a final determination under § 15.17 may, within 30 days after the notice of the final determination is sent, request the adjudicating official to re-review the record.
(b) The adjudicating official may require that another oral hearing be held on one or more of the issues in controversy, or permit the dissatisfied party to present further evidence or argument in writing, if the adjudicating official finds that the individual has:
(1) Presented evidence or argument that is sufficiently significant to require the conduct of further proceedings; or
(2) Shown some defect in the conduct of the adjudication under this subpart sufficient to cause substantial unfairness or an erroneous finding in that adjudication.
(c) Any rehearing ordered by the adjudicating official shall be conducted pursuant to § § 15.14 through 15.16.
(a) A final determination under § 15.17 shall be provided to the Department of Health and Human Services and sent by certified or registered mail to the individual and to the entity employing or sponsoring such individual if the individual is currently
(b) A final determination shall be effective upon the date the written determination is received by such entity or free clinic.
(c) A final determination that an individual provider shall not be deemed to be an employee of the Public Health Service shall apply to all acts or omissions of the individual occurring after the date the adverse final determination is received by such entity or free clinic.
(d) The Attorney General will inform the National Practitioner Data Bank of any final determination under § 15.17 that an individual shall not be deemed to be an employee of the Public Health Service for purposes of 42 U.S.C. 233.
(a) Not sooner than five years after the time for rehearing has expired, and no more often than once every five years thereafter, an individual who has been the subject of a final determination under § 15.17 may petition the initiating official for reconsideration of that determination and for reinstatement. The individual bears the burden of proof and persuasion.
(b) In support of the petition for reinstatement, the individual shall submit relevant evidence relating to the period since the original proceedings under this subpart and a statement demonstrating and explaining why treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would no longer expose the United States to an unreasonably high degree of risk of loss.
(c) Upon receiving a petition for reinstatement, the initiating official shall forward the petition, together with an evaluation and recommendation on whether the petition makes a prima facie case for reinstatement, to the adjudicating official. The adjudicating official shall determine, in the adjudicating official's discretion, whether the petition makes a prima facie case that the individual provider no longer would expose the United States to an unreasonably high degree of risk of loss. The adjudicating official's determination that a petition does not make a prima facie case for reinstatement is not subject to further review.
(d) If the adjudicating official determines that a prima facie case has been made for reinstatement, an administrative law judge shall be appointed in accordance with 5 U.S.C. 3105 and shall conduct such proceedings pursuant to §§ 15.14 through 15.16 as the administrative law judge deems necessary, in the administrative law judge's discretion, to determine whether the individual has established that treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would no longer expose the United States to an unreasonably high degree of risk of loss. After conducting such proceedings as the administrative law judge deems necessary, the administrative law judge shall certify the record to the adjudicating official and shall submit written findings of fact, conclusions of law, and a recommended decision to the adjudicating official pursuant to § 15.16.
(e) Following proceedings conducted under paragraph (d) of this section, the adjudicating official shall make the final determination on the basis of the record, findings, conclusions, and recommendations presented by the administrative law judge, which shall include the record from the original determination and any petition for rehearing. Copies of the adjudicating official's final determination shall be furnished to the parties. The adjudicating official's final determination shall constitute the final agency action.
(f) A determination that an individual is reinstated pursuant to this section shall be distributed in the same manner as provided in § 15.19 and shall apply only to acts or omissions of the individual occurring after the date of the final reinstatement determination.
Equal Employment Opportunity Commission.
Final rule.
The Equal Employment Opportunity Commission is issuing a final rule supplementing a final rule it published on December 20, 2018, entitled “Removal of Final ADA Wellness Rule Vacated by Court,” which removed the incentive section in ADA regulations. This rule removes the discussion about the incentive section from the ADA appendix.
This final rule is effective as of July 5, 2024.
Sarah DeCosse, Assistant Legal Counsel, (202) 921-3240 (voice); (800) 669-6820 (TTY), Office of Legal Counsel, 131 M Street NE, Washington, DC 20507. Requests for this document in an alternative format should be made to the Office of Communications and Legislative Affairs at (202) 921-3191 (voice), (800) 669-6820 (TTY), or (844) 234-5122 (ASL).
On May 17, 2016, the Equal Employment Opportunity Commission (EEOC or Commission) published a final rule under the authority of title I of the Americans with Disabilities Act (ADA), 42 U.S.C. 12101-12117, “provid[ing] guidance on the extent to which employers may use incentives to encourage employees to participate in wellness programs that ask them to respond to disability-related inquiries and/or undergo medical examinations.” 81 FR 31126 (May 17, 2016). This 2016 rule also discussed the incentive provisions in the ADA appendix.
On October 24, 2016, AARP filed a complaint in the U.S. District Court for the District of Columbia challenging the incentive section of the ADA rule. On August 22, 2017, the District Court concluded that the Commission did not provide sufficient reasoning to justify the incentive limit adopted in the ADA rule and remanded the rule to the EEOC for reconsideration without vacating it. Following a motion by AARP to alter or amend the court's summary judgment order, the court issued an order vacating the incentive section of the rule, which was 29 CFR 1630.14(d)(3), effective
Like the 2018 rule, this supplemental rule is not subject to the requirement to provide an opportunity for public comment because it falls under the good cause exception at 5 U.S.C. 553(b)(4)(B). The good cause exception is satisfied when notice and comment is “impracticable, unnecessary, or contrary to the public interest.”
Finally, because this rule implements a court order already in effect, the Commission has good cause to waive the 30-day effective date under 5 U.S.C. 553(d)(3).
The Commission has complied with the principles in section 1(b) of Executive Order 12866, as amended by Executive Order 14094, Regulatory Planning and Review. This rule is not a “significant regulatory action” under section 3(f) of the Executive Order and does not require an assessment of potential costs and benefits under section 6(a)(3) of the Executive Order.
This regulation contains no new information collection requirements subject to review by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
The Regulatory Flexibility Act, 5 U.S.C. 604, requires a final regulatory flexibility analysis for final rules only “after being required to publish a general notice of proposed rulemaking” or for interpretive internal revenue laws. This rule is being promulgated without a notice of proposed rulemaking for the reasons described above. Further, it does not concern internal revenue matters. Therefore, a regulatory flexibility analysis is not required.
This rule will not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, in 1995 dollars, updated annually for inflation. In 2023, that threshold was approximately $177 million. It will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501
Equal employment opportunity, Individuals with disabilities.
For the reasons set forth in the preamble, and under the authority of 42 U.S.C. 12116 and 12205a of the Americans with Disabilities Act, the Commission amends 29 CFR part 1630 as follows:
42 U.S.C. 12116 and 12205a of the Americans with Disabilities Act, as amended.
For the Commission.
Environmental Protection Agency (EPA).
Final rule; correction.
The Environmental Protection Agency (EPA) finalized multiple actions with incorporation by reference (IBR) in separate final rules that amended the same centralized IBR section. The amendatory instructions for that section were drafted based on a different publication order than the ultimate publication order of the affected rules. This rule corrects the instructions allowing Office of the Federal Register (OFR) editors to codify the amendments from each rule.
The corrections in instructions 1 and 2 are effective July 8, 2024, and the corrections in instructions 3 and 4 are effective July 15, 2024.
Muntasir Ali, Sector Policies and Program Division (D243-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, P.O. Box 12055, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-0833; email address:
The EPA published two final rules, 89 FR 39798 (May 9, 2024) and 89 FR 42932 (May 16, 2024), that each amended 40 CFR 60.17, the centralized IBR section for 40 CFR part 60. The amendatory instructions were drafted with the assumption that the two rules would publish in the reverse order. Given the order in which they published, if OFR editors were to effectuate the instructions, the editors would revise paragraphs other than the ones intended on July 8, 2024 (the effective date of the first rule), and July 15, 2024 (the effective date of the second rule), and would be unable to carry out an instruction in the second rule. This rule corrects the instructions allowing OFR editors to codify the amendments from each rule.
I. As of July 8, 2024, in FR Doc. 2024-09233 at 89 FR 39798 in the
II. As of July 15, 2024, in FR Doc. 2024-07002 at 89 FR 42932 in the
Environmental Protection Agency (EPA).
Final rule, correction.
The Environmental Protection Agency (EPA) is correcting final rules that appeared in the
The correction to 40 CFR 63.11099, at instruction 6, is effective July 8, 2024. The corrections to 40 CFR 60.481, 60.482-1, 60.481a, 60.482-1a, and 60.482-11a, at instructions 1 through 5, are effective July 15, 2024.
For the Gasoline Distribution rules, contact U.S. EPA, Attn: Ms. Jennifer Caparoso, Mail Drop: E143-01, 109 T.W. Alexander Drive, P.O. Box 12055, RTP, NC 27711; telephone number: (919) 541-4063; and email address:
The EPA published two final actions, 89 FR 39304 (May 8, 2024) and 89 FR 42932 (May 16, 2024), that amended 40 CFR part 63, subpart BBBBBB, and 40 CFR part 60, subparts VV and VVa, respectively. The Office of
In FR Doc. 2024-07002, appearing in page 42932 in the
The revision reads as follows:”
The revisions read as follows:”
In FR Doc. 2024-04629, appearing on page 39304 in the
Office of Acquisition Policy, General Services Administration (GSA).
Final rule; correction.
GSA is issuing a correction to GSAR Case 2022-G517, “Reduction of Single-use Plastic Packaging,” which published in the
Effective July 8, 2024.
Adina Torberntsson,
(3) Shipping packaging means packaging that serves as protection for the goods to ensure safe transport to the end customer, including:
(i) Ancillary packaging or transport packaging or tertiary packaging means packaging intended to secure the product, such as packing peanuts, wrapping materials, or molded materials. Ancillary packaging (or all shipping packaging) is typically outside of brand packaging.
(ii) Redundant packaging or unnecessary packaging means packaging that does not add any measurable protection to the supply being shipped, such as multiple layers of bubble wrap to an already durable product that is encased in a cardboard box. An example of this is a home testing kit with all plastic components already packaged in a cardboard box with cardboard inserts to absorb shock, that is then shipped in multiple layers of bubble wrap. In this example the bubble wrap is the redundant single-use plastic packaging.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; delay of effective date.
We, NMFS, are delaying the effective date of terminal gear requirements that amend the Pelagic Longline Take Reduction Plan (PLTRP) regulations in a final rule that published on June 6, 2023.
The effective date of the regulatory requirements contained in 50 CFR 229.36(d) that was published in a final rule at 88 FR 36965 on June 6, 2023, is delayed until January 1, 2025.
Erin Fougères, NMFS, Southeast Region, at 727-824-5312 or
On June 6, 2023, we published a final rule to amend the PLTRP (88 FR 36965). The PLTRP is required under section 118 of the Marine Mammal Protection Act (MMPA) to reduce mortality and serious injury (M/SI) of short-finned pilot whales (
The terminal gear requirements contained in 50 CFR 229.36(d) require: (1) circle hooks must have a round wire diameter not to exceed 4.05 millimeters (mm; 0.159 inches (in)) if the hooks are size 16/0, or 4.40 mm (0.173 in) if the hooks are size 18/0, and must have a straightening force not to exceed 300 pounds (lb; 136.08 kilograms (kg)); and (2) monofilament leaders and branch lines (
In the proposed rule to amend the PLTRP, we sought comments on the length of time necessary for manufacturers and industry to implement the new terminal gear regulations. Two commenters noted that manufacturers may need time to produce new hooks, but were concerned about additional delays to implementing regulations. Two additional commenters suggested that at least 1 full year was needed to plan and implement the hook design and allow fishermen time to work through existing inventories of hooks that would not meet the new regulatory requirements. These same commenters recommended that the fishery be given no less than 18 months following the publication of the final rule to implement the new hook requirements. In an effort to balance the conservation needs for the species and the practical and economic needs of the pelagic longline industry, we decided to delay the implementation of these terminal gear requirements by 12 months. Our final rule, which was published on June 6, 2023, and became effective on July 6, 2023, specified an effective date for the new terminal gear requirements of July 8, 2024.
Currently, some hooks that meet the specifications contained in 50 CFR 229.36(d) are available, although they are available in limited quantities and are not preferred broadly across the fishery. A primary hook manufacturer for the Atlantic pelagic longline fishing
We expect that the impact of delaying the marine mammal protections afforded by the terminal gear requirements until January 1, 2025, will be minor. Based on data from 2015 through 2019, the Potential Biological Removal (PBR) for the western North Atlantic stock of short-finned pilot whales is 236 and the average annual M/SI incidental to the Atlantic pelagic longline fishery was 136 animals (Hayes
In summary, we are delaying the effective date for the terminal gear requirements contained in 50 CFR part 229.36(d) in the amended PLTRP published on June 6, 2023 (88 FR 36965) for 6 months, until January 1, 2025, due to hook manufacturing delays. This delay in effective date will allow pelagic longline fishermen to purchase compliant hooks, once available, and to phase in their use. Although delaying the effective date will delay marine mammal protections afforded by the regulation, the impact is expected to be minor. We intend to provide no further extensions of the effective date beyond January 1, 2025.
The Assistant Administrator for Fisheries (AA) finds that there is good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because prior notice and opportunity for public comment on this temporary delay is unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule that published at 88 FR 36965 on June 6, 2023, has already been subject to notice and comment, and all that remains is to notify the public of this delay in the effective date of the previously noticed regulations. Providing additional prior notice and opportunity for public comment is contrary to the public interest because there is a need to immediately implement this action to delay the July 8, 2024, the effective date of the terminal gear requirements contained in 50 CFR 229.36(d) and to provide notice of the delay to affected fishery participants. Failure to extend the effective date risks inflicting potentially serious economic costs on the fishing industry, which were not intended or analyzed when the final rule was published, in the form of missed fishing opportunities and higher gear transition costs. We are temporarily delaying the effective date (see
For these same reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1361
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2009-10-04, which applies to certain Diamond Aircraft Industries GmbH (type certificate now held by Diamond Aircraft Industries Inc.) Model DA 40 and DA 40 F airplanes. AD 2009-10-04 requires repetitively inspecting the nose landing gear (NLG) leg for cracks and replacing the NLG leg if cracks are found. Since the FAA issued AD 2009-10-04, Transport Canada updated mandatory continuing airworthiness information (MCAI) to correct this unsafe condition on these products. This proposed AD results from changes made to the part replacement options and the repetitive inspections. This proposed AD would require doing repetitive detailed inspections of the NLG leg pivot axle for cracking and if cracking is found replacing that part with a serviceable part. This proposed AD would also require eventually replacing all NLG legs having certain part numbers with serviceable parts, if not already done, and prohibit installing affected parts. Replacing affected parts with serviceable parts would be terminating action for the repetitive inspections specified in this proposed AD. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this NPRM by August 19, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For Diamond Aircraft Industries material, contact Diamond Aircraft Industries Inc., 1560 Crumlin Sideroad, London, ON, Canada, N5V 1S2; phone: (519) 457-4041; email:
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For information on the availability of this material at the FAA, call (817) 222-5110.
Gabriel Kim, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7300; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
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
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 Gabriel Kim, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
The FAA issued AD 2009-10-04, Amendment 39-15899 (74 FR 22435, May 13, 2009) (AD 2009-10-04), for certain Diamond Aircraft Industries GmbH (type certificate now held by Diamond Aircraft Industries Inc.) Model DA 40 and DA 40 F airplanes. AD 2009-10-04 was prompted by MCAI originated by the European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union. EASA issued AD 2009-0016, dated January 22, 2009 (EASA AD 2009-0016), to address fatigue cracking of the NLG leg part number (P/N) D41-3223-10-00 at the pivot axle.
AD 2009-10-04 superseded and maintains the requirements of AD 2007-17-06, Amendment 39-15164 (72 FR 46549, August 21, 2007), which required repetitively inspecting the NLG leg for cracks and replacing the NLG leg if cracks are found. The FAA issued AD 2009-10-04 to exclude from the applicability any airplanes that have the improved NLG leg installed.
Effective November 15, 2017, the design and oversight responsibilities for the Model DA 40, DA 40 F, and DA 40 D airplanes were transferred from Diamond Aircraft Industries GmbH of Austria as the design approval holder, and EASA as the civil aviation authority, to Diamond Aircraft Industries Inc. (Diamond), of Canada as the new design approval holder, and Transport Canada as the civil aviation authority. After that transition, Transport Canada received several in-service reports of P/N D41-3223-10-00_1 cracking at the pivot axle and in some cases, fracture of the NLG leg. Investigation revealed that the failures were the result of fatigue cracking.
Since the FAA issued AD 2009-10-04, Transport Canada superseded EASA AD 2009-0016 and issued Transport Canada AD CF-2023-50, dated July 10, 2023 (Transport Canada AD CF-2023-50), to address failure of the NLG leg at the pivot axle by requiring initial and repetitive detailed inspections of NLG leg P/N D41-3223-10-00 and P/N D41-3223-10-00_1 to detect cracking, replacing a NLG leg, as required, with a serviceable part, and prohibiting the installation of NLG leg P/N D41-3223-10-00 or P/N D41-3223-10-00_1 as a replacement part.
Transport Canada AD CF-2023-20 differed from the Diamond material because Transport Canada AD CF-2023-20 required a detailed inspection of the pivot axle of the NLG leg P/N D41-3223-10-00 and P/N D41-3223-10-00_1 using a bright light and 10X magnifying glass instead of Type II visible dye for the inspection of the pivot axle. After Transport Canada AD CF-2023-50 was issued, the repetitive inspection interval was increased from 100 hours air time to 110 hours air time to align with the scheduled 100-hour inspection in chapter 5 of the DA 40 series Airplane Maintenance Manual. To require the change to Transport Canada AD CF-2023-50, Transport Canada issued AD CF-2023-50R1, dated November 29, 2023 (also referred to as the MCAI). The MCAI was published to address the time interval change of the repetitive inspection from 100-hour intervals to 110-hour intervals.
You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-1696.
The FAA reviewed Diamond Mandatory Service Bulletin MSB 40-091 Rev. 0, dated January 18, 2021, published with Diamond Aircraft Industries Work Instruction WI-MSB 40-091 Rev. 0, dated January 18, 2021 (issued as one document). This material specifies procedures for doing repetitive dye penetrant inspections of the NLG leg pivot axle for cracking and replacing the NLG for Model DA 40 airplanes.
The FAA also reviewed Diamond Mandatory Service Bulletin MSB F4-038 Rev. 0, dated January 18, 2021, published with Diamond Aircraft Industries Work Instruction WI-MSB F4-038 Rev. 0, dated January 18, 2021 (issued as one document). This material specifies procedures for doing repetitive dye penetrant detailed inspections of the NLG leg pivot axle for cracking and replacing the NLG for Model DA 40 F airplanes.
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
These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and material referenced above. 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.
This proposed AD would retain none of the requirements of AD 2009-10-04. This proposed AD would require doing repetitive detailed inspections of the NLG leg pivot axle for cracking and if cracking is found replacing that part with a serviceable part. This proposed AD would require eventually replacing all NLG legs having certain part numbers with serviceable parts, if not already done, and prohibiting installing affected parts. Replacing affected parts with serviceable parts would be terminating action for the repetitive inspections that would be required by this proposed AD.
The MCAI applies to Model DA 40 D airplanes, however, this proposed AD would not because that model does not have an FAA type certificate.
Although the Diamond material specifies to do dye penetrant inspections, the MCAI requires, and this proposed AD would require, using a bright light (minimum of 100 foot-candles) and 10X magnifying glass instead of dye penetrant.
The FAA estimates that this AD, if adopted as proposed, would affect 693 airplanes of U.S. registry.
The FAA estimates the following costs to comply with this proposed AD:
The costs of the proposed inspection and replacement of the NLG leg are based on all airplanes having an affected NLG installed. The FAA has no way of determining the number of airplanes that have the affected NLG installed, and those that do not have one installed would only be affected by the installation prohibition.
The FAA has included all known costs in its cost estimate. According to
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 that the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by August 19, 2024.
This AD replaces AD 2009-10-04, Amendment 39-15899 (74 FR 22435, May 13, 2009) (AD 2009-10-04).
This AD applies to Diamond Aircraft Industries Inc. (type certificate previously held by Diamond Aircraft Industries GmbH) Model DA 40 and DA 40F airplanes, all serial numbers, certificated in any category.
Joint Aircraft System Component (JASC) Code 3220, Nose/Tail Landing Gear.
This AD was prompted by failure of a NLG in the area of the pivot axle. The unsafe condition, if not addressed, could lead to damage to the airplane and injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
For the purposes of this AD the definitions in paragraphs (g)(1) through (3) of this AD apply:
(1) An “affected part” is an NLG leg having either P/N D41-3223-10-00 or P/N D41-3223-10-00_1.
(2) A “serviceable part” is an NLG leg that is not an affected part. NLG legs having P/N D41-3223-10-00_2 or P/N D41-3223-10-00_3 are considered serviceable parts.
(3) The “applicable mandatory service bulletin (MSB) for your airplane” is:
(i) For Model DA 40 airplanes: Diamond Aircraft Industries Mandatory Service Bulletin MSB 40-091 Rev. 0, dated January 18, 2021, published with Diamond Aircraft Industries Work Instruction WI-MSB 40-091 Rev. 0, dated January 18, 2021 (issued as one document).
(ii) For Model DA 40 F airplanes: Diamond Aircraft Industries Mandatory Service Bulletin MSB F4-038 Rev. 0, dated January 18, 2021, published with Diamond Aircraft Industries Work Instruction WI-MSB F4-038 Rev. 0, dated January 18, 2021 (issued as one document).
For all airplanes with an affected part installed, do the applicable actions specified in paragraphs (h)(1) and (2) of this AD.
(1) Within 25 hours time-in-service (TIS) or 30 days after the effective date of this AD, whichever occurs first, and thereafter at intervals not to exceed 110 hours TIS, perform the actions required by paragraphs (h)(1)(i) through (v) of this AD:
(i) Prepare the airplane for inspection of the pivot axle of the affected part in accordance with Section III, Paragraphs 1 through 4, of the Work Instruction of the applicable MSB for your airplane.
(ii) Clean the pivot axle of the affected part ensuring that any visible dye inspection residue is removed.
(iii) Perform a detailed inspection of the pivot axle of the affected part using a bright light (minimum of 100 foot-candles) and 10X magnifying glass to detect cracking, paying special attention to the radius at the top of the pivot axle as shown in Figure 1 of the Work Instruction of the applicable MSB for your airplane, except where Figure 1 refers to a “dye penetrant inspection” this AD does not require that type of inspection.
(iv) If any cracking is found during any inspection required by paragraph (h)(1)(iii) of this AD, before further flight, replace the affected part with a serviceable part, and reinstall the nose wheel fork in accordance with Section III, Paragraphs 8 through 12 of the Work Instruction of the applicable MSB for your airplane.
(v) If no cracking is found during any inspection required by paragraph (h)(1)(iii) of this AD and the compliance time specified in paragraph (h)(2) of this AD has not been exceeded, the affected part can remain installed until the compliance time specified in paragraph (h)(2) of this AD is reached. Reinstall the nose wheel fork in accordance with Section III, Paragraphs 8 through 12, of the Work Instruction of the applicable MSB for your airplane.
(2) Within 2,500 hours TIS or 24 months after the effective date of this AD, whichever occurs first, replace an affected part with a serviceable part. This part replacement is terminating action for the repetitive inspections required by paragraph (h)(1) of this AD.
As of the effective date of this AD, do not install an affected part on any airplane.
The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local
(1) For more information about this AD, contact Gabriel Kim, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7300; email:
(2) FAA Advisory Circular 43.13-1B, “Acceptable Methods, Techniques, and Practices—Aircraft Inspection and Repair,” Change 1, dated September 8, 1998, may be found at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Diamond Aircraft Industries Mandatory Service Bulletin MSB 40-091 Rev. 0, dated January 18, 2021, published with Diamond Aircraft Industries Work Instruction WI-MSB 40-091 Rev. 0, dated January 18, 2021 (issued as one document).
(ii) Diamond Aircraft Industries Mandatory Service Bulletin MSB F4-038 Rev.0, dated January 18, 2021, published with Diamond Aircraft Industries Work Instruction WI-MSB F4-038 Rev. 0, dated January 18, 2021 (issued as one document).
(3) For Diamond Aircraft Industries material contact Diamond Aircraft Industries Inc., 1560 Crumlin Sideroad, London, ON, Canada, N5V 1S2; phone: (519) 457-4041; email:
(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Commodity Futures Trading Commission.
Extension of comment period.
On May 10, 2024, the Commodity Futures Trading Commission (“Commission” or “CFTC”) issued a notice of proposed rulemaking (“NPRM”) titled Event Contracts. The comment period for the NPRM was scheduled to close on July 9, 2024. The Commission is extending the comment period for the NPRM by an additional thirty days.
The comment period for the NPRM titled Event Contracts is extended through August 8, 2024.
You may submit comments, identified by “Event Contracts, RIN 3038-AF14,” by any of the following methods:
•
•
•
Please submit your comments using only one of these methods. To avoid possible delays with mail or in-person deliveries, submissions through the CFTC Comments Portal are encouraged.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse, or remove any or all of your submission from
Nora Flood, Chief Counsel, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-6059,
On May 10, 2024, the Commission approved proposed amendments to its rules concerning event contracts in certain excluded commodities.
The NPRM was published on the Commission's website on May 10, 2024, and was made available for public comment through July 9, 2024, for a total comment period of 60 days.
The following appendix will not appear in the Code of Federal Regulations.
On this matter, Chairman Behnam and Commissioners Johnson, Goldsmith Romero, Mersinger, and Pham voted in the affirmative. No Commissioner voted in the negative.
Federal Energy Regulatory Commission.
Withdrawal of notice of proposed rulemaking and termination of rulemaking proceeding.
The Federal Energy Regulatory Commission (Commission) is withdrawing a notice of proposed rulemaking, which proposed to amend its regulations pursuant to section 215 of the Federal Power Act to require the Commission-certified Electric Reliability Organization (ERO) to submit performance assessments every three years; to include in its performance assessment a detailed discussion of any areas of the ERO's responsibilities and activities, or a Regional Entity's delegated functions, beyond those required by the Commission's regulations, that the Commission has identified at least 90 days prior to the expected performance assessment submission date; and to formalize the method for the ERO and Regional Entities to receive and respond to recommendations by the users, owners, and operators of the Bulk-Power System, and other interested parties for improvement of the ERO's operations, activities, oversight, and procedures.
The notice of proposed rulemaking published in the
1. On January 19, 2021, the Commission issued a notice of proposed rulemaking (NOPR) proposing to revise its regulations regarding the Electric Reliability Organization's (ERO) performance assessments pursuant to section 215 of the Federal Power Act (FPA).
2. Section 215 of the FPA requires the Commission to issue regulations that, among other things, provide for the certification of an entity as the ERO if it meets certain criteria.
3. In its NOPR, the Commission proposed to amend its regulations regarding the ERO performance assessments. First, the Commission proposed to require the ERO to submit assessments of its performance every three years instead of every five years. Second, the Commission proposed to add a requirement for the ERO to include in its performance assessment a detailed discussion of any areas of the ERO's responsibilities and activities, or a Regional Entity's delegated functions, beyond those required by the Commission's regulations, that the Commission has identified at least 90 days prior to the expected performance assessment submission date. Finally, the Commission proposed to formalize the method for the ERO and Regional Entities to receive and respond to recommendations by the users, owners, and operators of the Bulk-Power System, and other interested parties for improvement of the ERO's operations, activities, oversight, and procedures.
4. The Commission explained in the NOPR that it believed that the proposals would provide better continuity in its review of the ERO's operations, activities, oversight, procedures, and evaluation of the effectiveness of each Regional Entity in the performance of delegated functions. Further, the Commission explained that shorter performance assessment cycles could provide an opportunity for timelier identification and implementation of potential improvements to ERO performance and improve the efficiency of the overall performance assessment process.
5. Notice of the NOPR was published in the
6. In their joint comments, NERC and the Regional Entities oppose all proposed modifications. They assert that the proposed changes would place undue burden on ERO staff by directing their focus away from key activities that “would outweigh any potential benefits.”
7. Regarding the proposed 90-day advance notice of Commission requested information, NERC and the Regional Entities believe that the NOPR proposal does not consider “numerous, existing opportunities for coordination and timely feedback from industry, FERC Commissioners, and Commission staff.”
8. Finally, NERC and the Regional Entities oppose a formal solicitation of stakeholder feedback and recommendations. They say they already provide “extensive opportunities for stakeholder feedback on ERO operations, activities, oversight, and procedures, including areas for improvement.”
9. WIRAB, Joint Trade Associations, Public Citizen, and Resilient Societies support the proposed changes to the Commission's regulations.
10. The Commission withdraws the NOPR and terminates this proceeding. We appreciate the feedback that the Commission received in response to the NOPR. Considering NERC and the Regional Entities' concerns regarding the scope and implementation of the proposal and the increased burden on the ERO, that NERC will need to expend significant resources to address multiple Commission directives, and that the Commission will need to expend significant resources considering those responsive proposals,
11. Therefore, we exercise our discretion to withdraw the NOPR and terminate this rulemaking proceeding.
By the Commission. Commissioner Rosner is not participating.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) proposes to strengthen requirements and oversight relating to telecommunications certification bodies and measurement facilities to help ensure the integrity of these entities for purposes of the equipment authorization, to better protect national security, and to advance the Commission's comprehensive strategy to build a more secure and resilient communications supply chain.
Comments are due on or before September 3, 2024 and reply comments are due on or before October 3, 2024.
You may submit comments, identified by ET Docket No. 24-136, by any of the following methods:
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Jamie Coleman of the Office of Engineering and Technology, at
This is a summary of the Commission's
• All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
•
○ Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
○ U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
1. From 5G networks and Wi-Fi routers to baby monitors and fitness trackers, a wide array of radio-frequency (RF) devices are ubiquitous in Americans' daily lives and across our economy. The FCC's equipment authorization program is tasked with ensuring that all of these devices available to American businesses and consumers comply with our rules regarding, among other things, interference, radio-frequency (RF) emissions, and hearing aid compatibility. To ensure the efficient and effective review of tens of thousands of equipment authorizations annually, the Commission delegates certain important responsibilities to telecommunications certification bodies (TCBs) and measurement facilities (test labs) with regard to implementing our equipment authorization program. Now, as part of ongoing efforts to promote national security and protect our nation's communications equipment supply chain, the Commission has placed significant new national security related responsibilities on TCBs and test labs. By establishing new equipment authorization program rules that prohibit authorization of communications equipment that has been determined to pose an unacceptable risk to the national security of the United States or the security and safety of United States persons, these entities now must help ensure that such prohibited equipment is kept out of our nation's supply chain. Further, these entities are entrusted with receiving and maintaining sensitive and proprietary information regarding communications equipment. In light of these new and ongoing responsibilities and the persistent and evolving threats posed by untrustworthy actors seeking, among other things, to compromise our networks and supply chains, today the Commission seeks to strengthen its requirements for and oversight of TCBs and test labs by proposing new rules that would help ensure the integrity of these entities for purposes of the equipment authorization program, better protect national security, and advance the Commission's comprehensive strategy to build a more secure and resilient communications supply chain. It is vital for the Commission to ensure that these entities are not subject to influence or control by foreign adversaries or other untrustworthy actors that pose a risk to national security.
2. Specifically, the Commission proposes to prohibit from recognition by the FCC and participation in its equipment authorization program, any TCB or test lab in which an entity identified on the Covered List has direct or indirect ownership or control, and prohibit reliance on or use of, for purposes of equipment authorization, any TCB or test lab that is directly or indirectly owned or controlled by any entity on the Covered List or by any third party in which an entity identified on the Covered List has any direct or indirect ownership or control. Considering the national security concerns about entities identified on the Covered List, the Commission also directs the Office of Engineering and Technology (OET) to take swift action to suspend the recognition of any TCB or test lab directly or indirectly owned or controlled by entities identified on the Covered List, thereby preventing such entities from using their owned or controlled labs to undermine its current prohibition on Covered Equipment. Next, the Commission seeks comment on prohibiting recognition of any TCB or test lab directly or indirectly owned or controlled by a foreign adversary or any other entity that has been found to pose a risk to national security. To that end, and consistent with Commission action in other recent national security proceedings, the Commission seeks comment on whether and how it should consider national security determinations made in other Executive Branch agency lists in establishing eligibility qualifications for FCC recognition of a TCB or a test lab in its equipment authorization program. In addition, the Commission proposes that the prohibition would be triggered by direct or indirect ownership or control of 10% or more and, to help ensure that it has the information to enforce this requirement, TCBs and test labs would be required to report direct or indirect equity and/or voting interest of 5% or greater by any entity. Further, to implement the proposed national security prohibition, to ensure the integrity of the equipment authorization program and the impartiality of the TCBs and test labs within it, the Commission proposes to collect additional ownership and control information from TCBs and test labs. The Commission also seeks comment on other revisions concerning TCBs and test labs as the Commission seeks to address these issues.
3. The Commission's equipment authorization program, codified in the Commission's part 2 rules, plays a critical role in enabling the Commission to carry out its responsibilities under the Communications Act. Under section 302 of the Communications Act, the Commission is authorized to make reasonable regulations governing the interference potential of equipment that emit radiofrequency (RF) energy and that can cause harmful interference to radio communications, which are implemented through the equipment authorization program. In addition, the equipment authorization program helps ensure that communications equipment comply with certain other policy objectives—which include protecting the communications networks and supply chain from equipment that poses an unacceptable risk to national security.
4. Communications equipment must comply with the requirements under part 2 before they can be marketed in or imported to the United States. Under 47 U.S.C. 302a(e), the Commission has delegated certain important responsibilities to TCBs and test labs with regard to implementing the Commission's equipment authorization program.
5.
6. TCBs are responsible for reviewing and evaluating applications for equipment certification for compliance with the Commission's applicable requirements (including technical compliance testing and other requirements) and determining whether to grant or to dismiss the application based on whether it is in accord with Commission requirements. TCBs must meet all the appropriate specifications in the ISO/IEC 17065 standard, which include requirements to ensure that TCBs carry out their responsibilities in a “competent, consistent, and impartial manner.” Commission rules also impose certain obligations on each TCB to perform post-market surveillance, based
7. To carry out their prescribed equipment certification responsibilities, under current rules TCBs must be accredited based on determinations made by a Commission-recognized accreditation body and recognized by the Commission before they are authorized to evaluate applications for equipment authorization. Under Commission rules, TCBs must be located in the United States or in countries that have entered into applicable Mutual Recognition Agreements (MRAs) with the United States.
8. For TCBs located outside of the United States, designation is authorized in accordance with the terms of an effective bilateral or multilateral MRA to which the United States is a party. Pursuant to each MRA, participating countries agree to accept the equipment authorizations performed by the TCB-equivalent conformity assessment body of the other country. There are 15 FCC-recognized Designating Authorities in MRA-partnered countries. These Designating Authorities are governmental organizations associated with MRA-partnered economies. Currently there are 40 FCC-recognized TCBs, the majority of which are located in the United States and the rest are located in nine MRA-partnered countries.
9. Finally, the Commission will withdraw recognition of a TCB if the TCB's designation or accreditation is withdrawn, the Commission determines that there is “just cause,” or the TCB requests that it no longer hold a recognition. The Commission's rules also set forth specific procedures, including notification requirements, that the Commission will follow if it intends to withdraw its recognition of a TCB.
10.
11. For all granted applications, the TCBs must send to the FCC any test lab data and other information relied upon by the TCB. This information is made publicly available on the FCC website upon grant of the equipment authorization. Under the Commission's rules, test labs do not have any role or responsibility for making any certification decision on whether the equipment would be in compliance, nor do they have any role with respect to any other certification determination, including on whether the equipment constitutes “covered” equipment; all certification activities (evaluation, review, and decisional determinations) are reserved for TCBs.
12. Under Commission rules, testing for equipment certification can only be performed by a test lab that has been accredited by an FCC-recognized accreditation body and recognized by the Commission. Applicable rules require that these test labs be accredited based on ISO/IEC 17025. The Commission's rules require that entities wishing to become a recognized laboratory accreditation body must submit a written request to the Chief of OET and submit evidence concerning their credentials and qualifications to perform accreditation of laboratories that test equipment to Commission requirements, consistent with the technical requirements set forth under section 2.948(e). Applicants must successfully complete and submit a peer review. Under the ISO/IEC 17011 standard, accreditation body applicants must meet specified impartiality, management, and accreditation requirements, and otherwise meet accreditation body responsibilities. OET publishes its findings and maintains a web page on FCC-recognized accreditation bodies.
13. The Commission notes, however, that its rules do not currently require accreditation and FCC recognition of test labs that are relied upon as part of the Supplier's Declaration of Conformity (SDoC) process for obtaining an equipment authorization. In 2017, the Commission revised its rules to no longer require testing by accredited and FCC-recognized test labs for equipment with a reduced potential to cause harmful interference authorized in the SDoC process. The SDOC process applies, generally, to equipment that does not contain a radio transmitter and contains only digital circuitry—such as computer peripherals, microwave ovens, ISM equipment, switching power supplies, LED light bulbs, radio receivers, and TV interface devices.
14. The Commission recognizes four accreditation bodies in the U.S. that can designate test labs that operate in the United States. As for accreditation of test labs outside of the United States in countries that have entered into an MRA, § 2.948(f)(1) provides that test lab accreditation will be acceptable if the accredited laboratory has been designated by a foreign designating authority and recognized by the Commission under the terms of an MRA. Currently there are 24 such FCC-recognized test lab accreditation bodies outside the United States, located in 23 different MRA-partnered countries.
15. The Commission has a separate rule provision concerning the accreditation bodies that are permitted to accredit test labs in countries that do not have an MRA with the United States. If the test lab is located in a country that does not have an MRA with the United States, then the test lab must be accredited by an organization recognized by the Commission to perform accreditations in non-MRA countries. Currently, the Commission has recognized three such accrediting bodies. In response to requests from industry for clarifying the process by which test labs are accredited in non-MRA countries, the Commission in 2016 directed OET to provided clearer guidance on accreditation of test labs in non-MRA-partnered countries. Current rules do not preclude an accreditation body that is not in an MRA-partnered country from submitting a request to be recognized, but, to date, no accreditation body outside of an MRA-partnered economy has submitted a request for FCC recognition.
16. Under the Commission rules, if a test lab has been accredited for the appropriate scope for the types of equipment that it will test, then it “shall be deemed competent to test and submit test data for equipment subject to certification.” Test labs must be reassessed at least every two years. Under current procedures, if the accreditation body re-assesses the test lab and concludes that it continues to meet the requirements set forth under ISO/IEC 17025, the accreditation body will update the expiration date for the test lab's accreditation in the FCC's Equipment Authorization Electronic System (EAS) for a period of up to two years. While the Commission's rules currently provide procedures for FCC recognition of test lab accreditation bodies, its rules do not currently include specific Commission rules or procedures for withdrawing recognition of a test lab accreditation body.
17. The Commission maintains a list of FCC-recognized accredited test labs on its website, which currently lists nearly 640 test labs. Currently, MRA-
18.
19. In affirming in the
20.
21. On March 14, 2024, the Commission adopted the
22. In this NPRM, the Commission proposes and seeks comment on potential revisions to the Commission's rules designed to promote the integrity of its equipment authorization program and ensure that it serves the Commission's goals in protecting the communications equipment supply chain from entities posing unacceptable national security concerns. First, the Commission proposes to prohibit from recognition by the FCC and participation in the equipment authorization program, any TCB or test lab in which an entity identified on the Covered List (
23. In 2022 in the
24. In light of these determinations from expert Executive Branch agencies and Congress about the serious national security risks posed by entities with equipment on the Covered List, the Commission tentatively conclude that the Commission should not recognize or permit reliance on TCBs, test labs, or their accrediting bodies, or permit them to have any role in the Commission's equipment authorization program, if they have sufficiently close ties with Covered List entities. Accordingly, the Commission proposes to restrict the eligibility of entities that may serve as TCBs or test labs based on, at a minimum, the Covered List. Specifically, the Commission proposes to prohibit from recognition by the Commission and participation in its equipment authorization program, any TCB or test lab in which an entity identified on the Covered List (
25. Further, in the interest of national security, and out of an abundance of caution, the Commission finds that it is imperative that it not allow entities identified on its Covered List to use test labs they own or control to circumvent or otherwise undermine the Commission's prohibition on authorization of equipment identified on the Covered List or undermine the integrity of its supply chain. To that end, the Commission notes that OET has taken action to deny the re-recognition of a test lab apparently owned by an entity on the Covered List—Global Compliance and Testing Center of Huawei Technologies—while allowing this test lab to provide additional information on whether it is owned or controlled by Huawei Technologies Company or any other entity on the Covered List, and to show cause why it should be allowed re-recognition. Accordingly, the Commission directs OET to suspend, pending the outcome of this proceeding, recognition of any TCB or test lab for which there is sufficient evidence to conclude such TCB or test lab is owned or controlled by an entity identified on the Covered List, while allowing such TCB or test lab thirty days from the date of such suspension to certify, and provide supporting documentation, that no entity identified on the Covered List holds a 10% or more direct or indirect ownership interest or controlling interest in the TCB or test lab. The Commission believes this action is necessary to protect against additional national security risks to its equipment authorization program and supply chain, including protecting existing manufacturers from unknowing reliance on untrustworthy entities, pending the implementation of the additional ownership disclosures and transparency requirements the Commission proposes in this proceeding. Any burden on existing recognized TCBs or test labs should be minimal, as only those entities for whom OET has reason to question their ownership or control by an entity or entities identified on the Covered List will be impacted, and those TCBs or test labs will be given an opportunity to show cause why their FCC recognition should not be revoked for just cause. As the Commission weighs the importance of its national security against these minimal measures to prevent entities on the Covered List from owning or controlling FCC-recognized TCBs or test labs, the Commission finds that the compelling interest outweighs any burden imposed by such temporary suspension.
26. The Commission also seeks comment on whether there are other types of direct or indirect ownership or
27. The Covered List is only one source that identifies entities that raise national security concerns that potentially affect the communications equipment supply chain. Several Executive Branch agencies with particular national security responsibilities, and based upon specific statutory authorities, have recently developed or updated lists that identify entities, technologies, or services that they have determined raise national security concerns.
28. For example, the Department of Commerce maintains a list of “foreign adversary” countries that identifies any foreign government or foreign non-government person that the Secretary of Commerce has determined to have engaged in a “long-term pattern or serious instances of conduct significantly adverse to the national security interest of the United States or security and safety of United States persons.” The Department of Commerce's list of foreign adversaries currently includes several foreign governments and foreign non-government persons, including China (including Hong Kong), Cuba, Iran, and Russia. As discussed above, the Commission has recently relied in part on this foreign adversary list (as well as the Covered List) in both the
29. The Department of Defense (DOD), pursuant to section 1260H of the NDAA of 2021, has identified each entity that the Secretary of Defense has determined is a “Chinese military company” that is “operating directly or indirectly in the United States” and is “engaged in providing commercial services, manufacturing, producing, or exporting.” This DOD list (1260H List) currently includes 73 entities, including three of the five equipment manufacturers listed on the Covered List. Beginning in 2026, pursuant to other statutes, the DOD is prohibited from procurement from companies identified on the 1260H list.
30. Meanwhile, the Department of Commerce's Entity List identifies entities that are reasonably believed to be involved in, or to pose a significant risk of being or becoming involved in, activities contrary to U.S. national security or foreign policy interests. Among other things, the Entity List seeks to ensure that sensitive technologies do not fall into the hands of known threats. As discussed above, in its
31. Further, there are various other Executive Branch agency lists that address national security concerns in addition to those above. For instance, the Commerce Department also publishes a Military End User List, which identifies foreign parties that pursuant to the Export Administration Regulations (EAR) are prohibited from receiving particular items, including certain telecommunications equipment and software, unless the exporter secures a license. These parties have been determined by the U.S. Government to be “military end users,” and represent an unacceptable risk of use in or diversion to a “military end use” or “military end user” in China, Russia, or Venezuela. The Department of Treasury's Office of Foreign Assets Control, in coordination with the Department of State and DOD, administers various sanctions programs, including the Non-Specially Designated Nationals Chinese Military-Industrial Complex Companies List (CMIC List), which identifies individuals and companies as operating or having operated in the defense or surveillance technology sector of the People's Republic of China and from which U.S. persons are generally prohibited from purchasing or selling publicly traded securities. In section 5949 of the NDAA for FY 2023, Congress prohibited executive agencies from procuring, obtaining, or contracting with entities to obtain any electronic parts, products, or services that include “covered semiconductor chips” produced by three Chinese companies (and their subsidiaries or affiliates). The legislation authorizes DOD and the Commerce Department to designate other “covered products or services” if they determine them to be owned, controlled by, or connected to the government of a foreign country of concern, including China, Russia, North Korea, and Iran.
32. The Commission seeks comment on whether, and if so, the extent to which, the Commission should rely upon any of the various lists developed by the Executive Branch agencies that involve particular determinations relating to national security as a source to identify entities that raise national security concerns warranting a prohibition on participation in the Commission's equipment authorization program. While each list is designed to support specific prohibitions or agency objectives, the national security objectives common throughout each may warrant that the Commission take a cautious approach, especially with respect to those products for which relevant Federal agencies have expressed other security concerns. Are any such lists particularly suitable, or ill-fitting, for the equipment authorization context? The Commission also seeks comment on whether it should consider any other Executive Branch agency lists to rely upon as a source to identify entities that raise national security concerns and to restrict participation of those entities in the Commission's equipment authorization program. What other lists or sources of information should the Commission consider?
33. The Commission notes that it has a longstanding policy of according deference to the Executive Branch agencies' expertise in identifying risks to national security and law enforcement interests. With regard to each of these lists, to the extent that commenters recommend consideration of any of these lists with regard to eligibility for recognition of a TCB or test lab, the Commission asks that commenters explain why such eligibility should be restricted based on the list, as well as any other considerations the Commission should take into account in implementing such a restriction. The Commission invites comment on any other issues concerning consideration of any of these lists of Executive Branch determinations.
34. Further, the Commission seeks comment on other determinations on which it should rely to prohibit participation in its equipment authorization program. Specifically, should any “foreign entity of concern” as defined by the CHIPS Act be prohibited from participation? What about entities subject to exploitation, influence, or control by the government of a foreign adversary, such as foreign adversary state-owned enterprises,
35. To further protect the nation's telecommunications infrastructure and communications equipment supply chain from threats in an evolving national security landscape and to ensure the integrity of the equipment authorization program, the Commission proposes and seeks comment on collecting various ownership and control information from TCBs and test labs.
36. The Commission notes that, outside the context of the equipment authorization program, the Commission and other government agencies have routinely adopted rules to identify direct or indirect ownership or control of entities by third parties in order to address national security, competition, or other concerns. The Commission in many cases has required regulated entities to disclose information regarding related parties, whether those other parties control the entity, or have an ownership interest in it, or have some other relationship with the entity that is relevant to the public interest. For example, applicants seeking a new FCC satellite license, a modification of a satellite license, or the assignment or transfer of a satellite license, must disclose certain information both about foreign ownership and corporate ownership. The Commission's rules also require the disclosure of ownership information and corporate ownership information that would assist the Commission's public interest review of applications for international section 214 authority. The Commission notes that in the recent
37. Additionally, the Commission notes that other Executive Branch agencies also require entities to supply information on ownership and control so that the agencies can carry out their statutory responsibilities. For example, in the
38.
39. The Commission believes that collection of certain general ownership and control information places the Commission in the best position to evaluate any ownership interest concerns that potentially may be raised regarding an entity's impartiality or trustworthiness, particularly with regard to potential influence by entities that raise national security concerns. Further, the Commission also believes that such ownership information could be relevant to establishing appropriate “qualifications and standards” under section 302(e) regarding private entities to which the Commission has delegated and entrusted certain responsibilities as part of its equipment authorization program. The Commission has broad authority under section 302, when delegating certification responsibilities to private organizations such as TCBs and test labs, to “establish such qualifications and standards as it deems appropriate” for certification and testing activities. In particular, such data can be instructive in efforts to bolster the integrity of the equipment authorization
40. The Commission proposes that each TCB or test lab be required to report direct or indirect equity and/or voting interest in the TCB or test lab of 5% or greater. In other similar information collections, the Commission has agreed with Executive Branch determinations that a 5% threshold is appropriate because in some instances less-than-ten percent foreign ownership interest—or a collection of such interests—may pose a national security or law enforcement risk. The Commission seeks comment on this proposal. Alternatively, the Commission seeks comment on other levels and on whether it should raise or lower the ownership threshold for purposes of disclosure. If the Commission were to require submission of any such ownership information, how should such information be collected (
41. Further, to implement the proposed prohibition of Covered List entities discussed above and align the prohibition with the Commission's equipment authorization program rules regarding prohibited equipment, the Commission proposes to prohibit from recognition by the FCC and participation in its equipment authorization program any TCB or test lab in which an entity identified on the Covered List controls or holds a 10% or more direct or indirect ownership interest. The Commission seeks comment on this proposal. The Commission also invites comment on any other threshold interest level that commenters may believe appropriate, and requests that they provide support for their views. The Commission makes this proposal while noting that, in the
42. As discussed above, the Commission proposes to prohibit from recognition by the FCC and participation in its equipment authorization program, any TCB or test lab in which an entity identified on the Covered List controls or holds a 10% or more direct or indirect ownership interest and seeks comment on a similar prohibition with regard to other entities that raise national security concerns. The Commission also proposes to collect certain ownership information from TCBs and test labs. In this section, the Commission proposes and seeks comment on additional issues regarding implementation of its proposed prohibition as well as any other revisions the Commission may adopt in this rulemaking.
43.
44.
45. The Commission seeks comment on potential revisions concerning its rules and procedures for recognition and re-recognition of TCB accrediting bodies in light of any revisions that the Commission may adopt in this proceeding. What revisions are needed, if any, to ensure that the accreditation body's assessment of entities seeking to become TCBs includes a review of the TCB's ownership and compliance with any requirements the Commission may adopt in this proceeding?
46.
47. The Commission also seeks comment on whether any clarifications or revision of rules or procedures, either for a new accreditation or a continued accreditation, may implicate or affect U.S. international agreements such as MRAs concerning TCBs and TCB accreditation. Finally, to the extent any commenter proposes further clarification or revisions, the Commission asks that they address any implications under the existing MRAs and whether and how to implement any suggested changes.
48.
49.
50. The Commission invites comment on the procedures by which it would withdraw recognition of a TCB. The Commission's rules require that it notify a TCB in writing when it has concerns or evidence that the TCB is not certifying equipment in accordance with the Commission rules and policies, and request that the TCB explain and correct any deficiencies. The rules also provide particular procedures for withdrawal, including notification requirements such as providing TCBs at least 60 days to respond. To the extent the TCB was designated and recognized pursuant to an MRA, the Commission must consult with the U.S. Trade Representative, as necessary, concerning any disputes involving the Telecommunications Trade Act of 1988. In light of the Commission's proposals and issues raised above, the Commission invites comment on whether it should consider clarifications or revisions to the Commission's rules or policies, including the current notification requirements and procedures, and if so whether and to what extent such changes would affect the MRAs.
51. In this section, the Commission proposes and seeks comment on additional issues regarding implementation of its proposed prohibition, as well as any other revisions the Commission may adopt in this rulemaking, concerning test labs.
52.
53.
54. Also, in light of evolving national security risks, such as those that may be reflected in the Commerce Department's “foreign adversaries” list, the Commission proposes to preclude accreditation bodies associated with any such foreign adversary and seeks comment. How would such association be determined? The Commission also seeks comment on whether test lab accreditation bodies should be located only in the United States or other MRA-partnered countries.
55.
56. The Commission also requests comment on whether any of these Commission rules or policies concerning reassessment of test lab accreditation every two years should be clarified or revised in order to help ensure that untrustworthy labs are not recognized and do not be continued to be recognized by the Commission. The Commission notes that if it were to adopt clarifications of any ISO/IEC 17025 principles (
57. Finally, the Commission seeks comment on whether, in light of evolving national security concerns, the Commission should revisit its rules and procedures for recognizing test labs with regard to some or all of the countries in economies that do not have an MRA with the United States. For instance, should the Commission no longer recognize any test lab that is located within a “foreign adversary” country that does not have an MRA with the United States? To date, the Commission has recognized three accreditation bodies, all located in the United States, to designate test labs that are located in non-MRA countries. Under the Commission's current rules, these bodies accredit test labs based on ISO/IEC 17025, the same standard by which test labs located in the United States and other MRA-partnered countries are accredited. The Commission has recognized numerous test labs located in economies that do not have an MRA with the United States. The Commission also notes that a number of these test labs also are owned and controlled by TCBs, which must be located in economies that have entered into MRAs with the United States.
58.
59.
60. To the extent that the Commission ultimately adopts any of the proposals discussed above (
61. As with the Commission's discussion of TCBs above, the Commission also believes that repeated failure of a test lab to provide accurate test results, or a test lab's lack candor with regard to interactions with the Commission, would constitute sufficient basis for withdrawal of recognition, and propose that were such circumstances to be presented, the Commission would move forward with withdrawing any existing FCC recognition of such a test lab. The Commission seeks comment on this proposal. The Commission also invites comment on other bases that would merit the Commission proceeding with withdrawing recognition of any existing test lab.
62.
63.
64. Accordingly,
65.
Administrative practice and procedures, Communications, Communications equipment, Disaster assistance, Radio, Reporting and recordkeeping requirements, and Telecommunications.
For the reasons discussed in the document, the Federal Communications Commission proposes to amend 47 CFR part 2 as follows:
47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
(b) Each entity named on the Covered List, as established pursuant to § 1.50002 of this chapter, must provide to the Commission the following information: the full name, mailing address or physical address (if different from mailing address), email address, and telephone number of each of that named entity's associated entities (
(1) Each entity named on the Covered List must provide the information described in paragraph (b) of this section no later than [30 DAYS AFTER PUBLICATION OF FINAL RULES IN THE
(2) Each entity named on the Covered List must provide the information described in
(3) Each entity named on the Covered List must notify the Commission of any changes to the information described in
(c) * * *
(b) * * *
(1) * * *
(ii) State the name of the test laboratory, company, or individual performing the testing. The Commission may request additional information regarding the test site, the test equipment, or the qualifications of the company or individual performing the tests, including documentation identifying any entity that holds a 5% or greater direct or indirect equity or voting interest in the test laboratory, company, or individual performing the testing;
The revisions and additions read as follows:
(b) * * *
(1) * * *
(viii) Certification from each measurement facility that no entity identified on the Covered List has, possesses, or otherwise controls an equity or voting interest of 10% or more in the measurement facility; and
(ix) Documentation identifying any entity that holds a 5% or greater direct or indirect equity or voting interest in the measurement facility.
(c) * * *
(9) Each recognized laboratory must certify to the Commission, no later than [30 DAYS AFTER THE EFFECTIVE DATE OF A FINAL RULE], and no later than 30 days after any relevant change in the required information takes effect, that no entity identified on the Covered List has, possesses, or otherwise controls an equity or voting interest of 10% or more in the laboratory;
(g) No equipment will be authorized under either the certification procedure or the Supplier's Declaration of Conformity if such authorization is reliant upon testing performed at a laboratory or measurement facility in which any entity identified on the Covered List, as established pursuant to
(h) Regardless of accreditation, the Commission will not recognize any test lab:
(1) In which any entity identified on the Covered List, as established pursuant to
(2) That fails to provide, or provides a false or inaccurate, certification as required in paragraph (c)(9) of this section; or
(3) That repeatedly fails to provide accurate test results or lacks candor with regard to interactions with the Commission.
(c) The Commission will not recognize a laboratory accreditation body that has any affiliation with a foreign adversary as designated by the U.S. Department of Commerce at 15 CFR 7.4.
(d) The Commission will not recognize any TCB for which any entity identified on the Covered List, as established pursuant to
(e) * * *
(2) The Commission will notify a TCB in writing of its intention to withdraw or limit the scope of the TCB's recognition and provide at least 60 days for the TCB to respond. In the case of a TCB designated and recognized pursuant to an bilateral or multilateral mutual recognition agreement or arrangement (MRA), the Commission shall consult with the Office of the United States Trade Representative (USTR), as necessary, concerning any disputes arising under an MRA for compliance with the Telecommunications Trade Act of 1988 (Section 1371-1382 of the Omnibus Trade and Competitiveness Act of 1988).
(i) The Commission will withdraw its recognition of a TCB if:
(A) The TCB's designation or accreditation is withdrawn, if the Commission determines there is just cause for withdrawing the recognition;
(B) The TCB requests that it no longer hold its designation or recognition;
(C) The TCB fails to provide the certification required in paragraph (8); or
(D) The TCB fails to fulfill its obligations to the Commission to ensure that no authorization is granted for any equipment that is produced by any entity identified on the Covered List, established pursuant to § 1.50002 of this chapter.
(ii) The Commission will limit the scope of equipment that can be certified by a TCB if its accreditor limits the scope of its accreditation or if the Commission determines there is good cause to do so.
(iii) The Commission will notify a TCB in writing of its intention to withdraw or limit the scope of the TCB's recognition and provide at least 60 days for the TCB to respond. In the case of a TCB designated and recognized pursuant to an bilateral or multilateral mutual recognition agreement or arrangement (MRA), the Commission shall consult with the Office of the United States Trade Representative (USTR), as necessary, concerning any disputes arising under an MRA for compliance with the Telecommunications Trade Act of 1988 (Section 1371-1382 of the Omnibus Trade and Competitiveness Act of 1988).
(6) The Commission will not recognize as a TCB any organization in which any entity identified on the Covered List, as established pursuant to
(7) A TCB must have an organizational and management structure in place, including personnel with specific training and expertise, to verify that no authorization is granted for any equipment that is produced by any entity identified on the Covered List, established pursuant to § 1.50002 of this chapter.
(8) Each recognized TCB must certify to the Commission, no later than [30 DAYS AFTER THE EFFECTIVE DATE OF A FINAL RULE], and no later than 30 days after any relevant change in the required information takes effect that no entity identified on the Covered List has, possesses, or otherwise controls an equity or voting interest of 10% or more of the TCB.
(9) Each recognized TCB must provide to the Commission, no later than [90 DAYS AFTER THE EFFECTIVE DATE OF A FINAL RULE], and no later than 30 days after any relevant change in the required information takes effect, documentation identifying any entity that holds a 5% or greater direct or indirect equity or voting interest in the TCB.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) seeks comment on changes to its rules regarding letters of credit for recipients of high-cost support awarded through competitive bidding. Specifically, the Commission seeks comment on changing the rules governing which United States banks are eligible to issue such letters. It also seeks comment on modifying the letter of credit rules for Connect America Fund Phase II (CAF II) support recipients that have met all of their deployment and reporting obligations, along with allowing certain Rural Digital Opportunity Fund (RDOF) support recipients to lower the value of their letters of credit.
Comments are due on or before August 5, 2024 and reply comments are due on or before August 19, 2024. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this document, you should advise the contact listed below as soon as possible.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). You may submit comments, identified by WC Docket Nos. 10-90, 18-143, 19-126, 24-144; AU Docket Nos. 17-182, 20-34; GN Docket No. 20-32, by any of the following methods:
•
•
• Filings can be sent by hand or messenger delivery, by commercial courier, or by the U.S. Postal Service.
• Hand-delivered or messenger-delivered paper filings for the Commission's Secretary are accepted between 8 a.m. and 4 p.m. by the FCC's mailing contractor at 9050 Junction Drive, Annapolis Junction, MD 20701. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
• Commercial courier deliveries (any deliveries not by the U.S. Postal Service) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. Filings sent by U.S. Postal Service First-Class Mail, Priority Mail, and Priority Mail Express must be sent to 45 L Street NE, Washington, DC 20554.
•
Nathan Eagan at
This is a summary of the Commission's notice of proposed rulemaking (NPRM) in WC Docket Nos. 10-90, 18-143, 19-126, 24-144; AU Docket Nos. 17-182, 20-34; GN Docket No. 20-32; FCC 24-64, adopted June 6, 2024 and released June 7, 2024. The full text of this document is available for public inspection during regular business hours at Commission's headquarters 45 L Street NE, Washington, DC 20554 or at the following internet address:
1. In the NPRM, the Commission seeks comment on modifying Letter of Credit (LOC) rules for Universal Service Fund High-Cost support authorized through a competitive process. The Commission also seeks comment on modifying the required value of a letter of credit for recipients of the RDOF support. Finally, it seeks comments on making the waiver of certain aspects of the LOC rules permanent for recipients of CAF II support to align with the RDOF LOC requirements. The Commission is seeking comment in these areas to explore potential ways to facilitate providers' compliance with program requirements while facilitating broadband deployment in unserved and underserved areas, and helping providers to meet their deployment milestones.
2. Currently, the Commission's rules require that entities authorized to receive High-Cost support authorized through a competitive process have an LOC from a United States bank with a Weiss bank safety rating of B− or better. When the Commission first adopted this rule, approximately 3,600 banks qualified to issue letters of credit. In the last 2 years, however, nearly half of those banks have lost their eligibility to issue LOCs as they have seen their Weiss rating fall below a B−. Therefore, many carriers authorized to receive CAFF II Auction or RDOF support face the possibility of having their support withheld until they obtain a new LOC from a qualifying bank, and these carriers must incur increased costs and administrative burdens associated with obtaining a new LOC from a qualifying bank. Accordingly, the Commission seeks comment on whether the Commission should modify the current requirement of a B− or better Weiss safety rating.
3. In addition, RDOF support recipients are required to maintain LOCs that increase in value on an annual basis. Banks issuing LOCs generally require RDOF support recipients to maintain sufficient cash reserves to support the LOC, which impacts the financial resources available for the provider's operations, including deployment. As part of RDOF's rules, support recipients that meet their optional or required deployment milestone are allowed to reduce the value of their required LOCs to one year of their total support once Universal Service Administrative Company (USAC) has verified deployment. This flexibility was intended to balance our responsibility to protect program funds while simultaneously reducing the financial burdens on RDOF support recipients to participate in the program as they met their deployment milestones. In the NPRM, the Commission seeks comment on providing additional flexibility by allowing an RDOF support recipient to lower the value of its LOC to one year of support if it has deployed service to 10 percent of its locations by the end of its second year of support, instead of 20 percent, and the Commission seeks comment on whether such a waiver would apply to recipients whose two-year optional milestone has already occurred.
4. Finally, the Commission seeks comment on making our waiver of certain aspects of the CAF II LOC rules permanent, and thereby continuing to allow CAF II support recipients that have met their deployment and reporting obligations to follow the RDOF's LOC rules, and maintain LOCs at lower values.
5.
6. When the Commission adopted its requirement that banks maintain a Weiss bank safety rating of B− or better, it reasoned that Weiss offered “an
7. First, the Commission seeks comment on any alternatives to using the Weiss bank safety rating. The Commission notes that the objective is to protect the Universal Service Fund and expenditures, by ensuring that carriers have an LOC that can be relied upon, while simultaneously permitting carriers to choose from a reasonably wide range of banks that can issue LOCs for purposes of complying with program rules. The Commission seeks comment on alternative approaches that would balance these objectives.
8. The Commission seeks specific comment on Bank of America's (BOA) proposed alternative method of determining a bank's eligibility. BOA proposed that a U.S. bank could be eligible to issue LOCs to auction support recipients if the bank had either: (1) a Weiss bank safety rating of B− or better; or (2) a long-term unsecured credit rating issued by a widely-recognized credit rating agency that is equivalent to a BBB− or better rating by Standard & Poor's, which is the requirement for non-U.S banks. How would the Commission apply this proposed standard? Is the term “widely-recognized” credit rating agency a bright-line rule that Commission staff could easily apply? What constitutes a widely-recognized agency? Would Commission staff or the Administrator be able to quickly and easily determine a bank's long-term unsecured credit rating? Are these ratings publicly available and free to access? If these ratings are not publicly available and free to access, how would Commission staff or the Administrator verify a bank's rating? As noted, Commission staff or the Administrator should not be required to make any discretionary judgments about a bank's eligibility. Would this proposal provide additional alternatives to small businesses that have won support in Auction 903 or 904 or that may win support in a 5G Fund auction? The Commission also seeks comment more generally on alternative rating systems and alternative approaches to rating systems that could be used to evaluate the fitness of a U.S. bank, including any alternatives adopted by other agencies. What are the advantages or disadvantages of those rating systems and other approaches?
9. As another alternative, the Bank Policy Institute proposes that the “FCC reconsider its use of Weiss Ratings” and accept “letters of credit from any federally-supervised bank with an investment grade-rating for banks of $100 billion or more in total assets or with a certificate that the bank is “well capitalized” for banks with assets below $100 billion.” The Commission seeks comment on this proposal. The Bank Policy Institute also argues that if the Commission wishes to use a credit-rating organization, it should use one of the ten nationally recognized credit rating statistical organizations which, unlike Weiss, are subject to SEC regulation. The Commission also seeks comment on the Bank Policy Institute's contention that using ratings from credit-rating organizations would be inconsistent with section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
10. Second, the Commission seeks comment on whether continuing to use only the Weiss ratings, but instead allowing issuing banks to have a lower bank safety rating, would provide a solution. Weiss currently rates 4,526 banks, and 3,923 of them have a bank safety rating of C− or better. According to Weiss, a C rating means “This is a cautionary or yellow flag. In the event of a recession or major financial crisis, the Commission feels this company may encounter difficulties in maintaining its financial stability.” Would using that threshold address the issues that have been raised and still protect the Fund? The Commission notes that the LOC plays a vital role in ensuring ability to recoup funds in the event that an auction support recipient fails to complete its deployment obligations, and the Commission needs to be certain that the banks issuing the LOCs will be able to honor them. Weiss's ratings are publicly available and free to use, which allows for bright-line determinations about a bank's eligibility. Are there other advantages or disadvantages with using Weiss ratings but changing the requirement from B− or higher to C− or higher? Would changing the requirement from a minimum of a B− to C+ or C strike a better balance? The Commission notes that an interested party has suggested that any Weiss-rated bank with “certain of the five Weiss indices” “at a certain level” should be eligible to issue LOCs to participants in the programs that award high-cost support through competitive bidding. The Commission seeks comment on that proposal, and on how such a proposal could work. Are there any issues the Commission should consider with regard to administering and implementing a change in the rules regarding bank eligibility? If so, the Commission seeks comment on those issues, along with any potential solutions.
11.
12. The Commission seeks comment on the burdens of maintaining the LOC values currently required by the rules,
13. The Commission emphasizes that any such change would be limited to the optional milestone and would not impact the requirement that all RDOF support recipients must deploy service to 40% of eligible locations by the end of their third year of support. In the event that an RDOF support recipient then failed to timely meet its 40% deployment obligation, the value of its LOC would need to increase to reflect the amount required under the current rules.
14.
15.
16.
17.
18.
19.
20. As required by the Regulatory Flexibility Analysis (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the NPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments. In addition, the NPRM and IRFA (or summaries thereof) will be published in the
21. In the NPRM, the Commission seeks comment regarding the rules determining a bank's eligibility to issue LOCs for winners of Auction 903 and 904 support, along with winners of 5G Fund support and Phase II fixed support from the Puerto Rico/USVI Fund. The Commission's rules currently require recipients for support to maintain a letter of credit from a United States bank with a Weiss bank safety rating of B− or better. More than 1,600 U.S. banks that had previously been eligible to issue LOCs to support recipients have seen their Weiss bank safety ratings fall below a B− in the past two years and, correspondingly, lost their eligibility to supply support recipients with LOCs. The Commission recognizes that the current rules may burden those support recipients who wish to maintain their existing relationship with a bank that previously issued them an LOC. The Commission seeks comments on using a different Weiss letter grade as the threshold for bank eligibility. The Commission alternatively seeks comments on using a different rating system to evaluate a bank's health. The Commission also seeks comments on allowing Auction 904 support recipients who have deployed service to at least 10% of their required locations by the end of their second year of support to lower the value of their LOCs to one year of support. Finally, the Commission seeks comments on allowing Auction 903 support recipients that have met their deployment and reporting obligations to continue to maintain their LOCs under the Auction 904 rules.
22. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.” A “small business concern” is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
23.
24. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2022, there were approximately 530,109 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.
25. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2022 Census of Governments indicate there were 90,837 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number, there were 36,845 general purpose governments (county, municipal, and town or township) with populations of less than 50,000 and 11,879 special purpose governments (independent school districts) with enrollment populations of less than 50,000. Accordingly, based on the 2022 U.S. Census of Governments data, the Commission estimates that at least 48,724 entities fall into the category of “small governmental jurisdictions.”
26. The small entities that may be affected are Wireline Providers, Wireless Carriers and Service Providers, and internet Service Providers.
27.
28. In the NPRM, the Commission seeks comment on alternative methods of evaluating a bank's ability to provide a LOC to winners of Auction 903 and 904 support, along with winners of 5G Fund auctions. The NPRM specifically seeks comment on modifying the rules to allow more banks to become or remain eligible to issue LOCs to Auctions 903 and 904 support recipients and to 5G Fund support recipients, which may alter reporting, recordkeeping, and compliance obligations for small entities that receive support. The NPRM also seeks comments on allowing more Auction 904 support recipients to lower the value of their LOCs.
29. The potential changes in the NPRM are intended to reduce the administrative burden on recipients of Auctions 903 and 904 support and 5G Fund support. The potential changes the Commission seeks comment on would allow support recipients, including small entities, to minimize their expenses by maintaining their existing LOC with the bank that issued it. As a result, if there is an economic impact on small entities as a result of these proposals, however, the Commission expects the impact to be a positive one. Any potential changes the Commission seeks comment on would not add any additional compliance requirements for small entities, or additional costs for professional skills, because support recipients are already required to maintain a LOC under the current rules. The proposed changes would allow support recipients to maintain their existing LOCs instead of obtaining new ones. The Commission also seeks comments on allowing Auction 904 support recipients who have deployed service to at least 10% of their required locations by the end of their second year of support to lower the value of their LOCs. Finally, the Commission seeks comment on allowing Auction 903 support recipients that have met their deployment and reporting obligations to
30. The RFA requires an agency to describe any significant alternatives that could minimize impacts to small entities that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
31. In the NPRM, the Commission takes steps to minimize the economic impact on small entities and considers significant alternatives by proposing and seeking input on alternative proposals designed to balance our goal of allowing providers to obtain an LOC from a number of different banks while also ensuring these banks are able to fulfill those LOCs in the event that the LOCs need to be drawn upon. With these goals in mind, in the NPRM, the Commission sought comment on whether a different standard for evaluating banks would allow providers to obtain LOCs from a wider range of banks while simultaneously protecting our investment and the Universal Service Fund.
32. The Commission also considered alternatives to the existing rules, by seeking comment on alternative standards that could be used to evaluate the health and suitability of a bank. For example, Bank of America proposed on alternative method of determining a bank's eligibility that includes the current Weiss rating of B− or better or a long-term unsecured credit rating issued by a widely-recognized credit rating agency that is equivalent to a BBB− or better rating by Standard & Poor's, which is the requirement for non-U.S banks. In light of the economic burdens that auction support recipients could face by being required to obtain new LOCs from different banks, the Commission sought comments on the most effective ways of allowing those support recipients to maintain their LOCs with the banks that originally issued them, as long as the Commission is confident that the bank's economic health is sufficient.
33. The matters discussed in the NPRM are designed to ensure the Commission has a better understanding of both the benefits and the potential burdens associated with the different actions and methods before adopting its final rules. To assist in the Commission's evaluation of the economic impact on small entities, as a result of actions the Commission has proposed in the NPRM, and to better explore options and alternatives, the Commission has sought comment from the parties. In particular, the Commission seeks comment on whether any of the economic burdens associated the filing, recordkeeping and reporting requirements described can be minimized for small businesses. Through comments received in response to the NPRM and the IRFA, including costs and benefits information and any alternative proposals, the Commission expects to more fully consider ways to minimize the economic impact on small entities. The Commission's evaluation of the comments filed in this proceeding will shape the final alternatives it considers, the final conclusions it reaches, and the actions it ultimately takes in this proceeding to minimize any significant economic impact that may occur on small entities as a result of any final rules that are adopted.
34. None.
35. Accordingly,
36.
37.
July 10, 2024 10:00 a.m.-11:00 a.m. ET.
On July 10, 2024, the Board will meet virtually.
This meeting will be closed to the public.
The International Broadcasting Advisory Board (Board) will conduct a meeting closed to the public at the date and time listed above. Board Members (membership includes Chair Kenneth Jarin, Luis Botello, Jamie Fly, Jeffrey Gedmin, Michelle Giuda, Kathleen Matthews, Under Secretary Elizabeth Allen (Secretary of State's Representative)), Chief Executive Officer of the U.S. Agency for Global Media (USAGM), the USAGM General Counsel and Acting Board Secretary to the Board, the Secretariat to the Board, and recording secretaries will attend the closed meeting. Certain USAGM staff members who may be called on to brief or support the Board also may attend.
The USAGM General Counsel and Acting Board Secretary has certified that, in his opinion, exemptions set forth in the Government in the Sunshine Act, in particular 5 U.S.C. 552b(c)(2), (6), and (9)(B), permit closure of this meeting.
The entirety of the Board's membership approved the closing of this meeting.
The closed meeting will focus on discussing the development of internal rules and practices to govern Board processes and functions. This includes developing processes or rules relating to IBAB, USAGM, and the USAGM networks. Publicizing these deliberations would frustrate the implementation of the very items they will be proposing. [This related to (2) and (9).]
In the event that the time, date, or location of this meeting changes, USAGM will post an announcement of the change, along with the new time, date, and/or place of the meeting on its website at
Although a separate federal entity, USAGM prepared this notice and will continue to support the Board in accordance with 22 U.S.C. 6205(g).
Persons interested in obtaining more information should contact USAGM's Executive Director Oanh Tran at (202) 920-2583.
United States Commission on Civil Rights.
Notice of Commission public business meeting.
Friday, July 12, 2024, 10:00 a.m. ET.
Meeting to take place virtually and is open to the public via livestream on the Commission's YouTube page:
Angelia Rorison: 202-376-8371;
In accordance with the Government in Sunshine Act (5 U.S.C. 552b), the Commission on Civil Rights is holding a meeting to discuss the Commission's business for the month. This business meeting is open to the public. Computer assisted real-time transcription (CART) will be provided. The web link to access CART (in English) on Friday, July 12, 2024, is
Census Bureau, Department of Commerce.
Notice of public virtual meeting.
The Census Bureau is giving notice of a virtual meeting of the 2030 Census Advisory Committee (2030 CAC or Committee). The Committee will assist the Census Bureau in devising strategies to increase awareness of and participation in the next decennial census, reduce barriers to response, and enhance the public's trust and willingness to respond. Last minute changes to the schedule are possible, which could prevent giving advance public notice of schedule adjustments.
The virtual meeting will be held on:
• Friday, July 26, 2024, from 10:30 a.m. to 5:30 p.m. EDT.
Please visit the Census Advisory Committee website at
Shana Banks, Advisory Committee Branch Chief, Office of Program, Performance and Stakeholder Integration (PPSI),
The Committee will provide insight, perspectives, and expertise through recommendations on planning and implementation of the 2030 Census. The members of the 2030 CAC are appointed by the Director of the Census Bureau. The Committee has been established in accordance with the Federal Advisory Committee Act (5 U.S.C. 1001
All meetings are open to the public. Public comments will be accepted in writing only to
Robert L. Santos, Director, Census Bureau, approved the publication of this Notice in the
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
BTOS uses ongoing data collection to produce high frequency, timely, and granular information about current economic conditions and trends. BTOS is the only biweekly business tendency survey produced by the federal statistical system, providing unique and detailed data during times of economic or other emergencies. The BTOS initial target population is all nonfarm, single-location employer businesses with receipts of $1,000 or more in the United States, the District of Columbia, and Puerto Rico. The current sample consists of approximately 1.2 million single-unit businesses split into six panels. Data collection occurs every two weeks, and businesses in each panel are asked to report once every 12 weeks for one year. Current data from BTOS are representative of all single location employer businesses (excluding farms) in the U.S. economy and are published every two weeks. The data are available at the national and state levels, in addition to the 25 most-populous Metropolitan Statistical Areas (MSAs). North American Industry Classification System (NAICS) sector, subsector, and state by sector are also published, as are employment size class, and sector by employment size class data, according to the same timeline.
Data from BTOS are currently used to provide timely data to understand the economic conditions being experienced by single unit businesses; BTOS provides near real time data on key items such as revenue, paid employees, hours worked as well as inventories which is being added in for the second sample collection year; a new sample collection is conducted each year.
BTOS also provides high level information on the changing share of businesses facing difficulties stemming from supply chain issues, interest rate changes, or weather events. Previously, there had been few data sources available to policymakers, media outlets, and academia that delivered near real-time insights into economic trends and outlooks. BTOS data has been used by the Small Business Administration to evaluate the impact of regulatory changes. Use of the BTOS data (or additional requirements) is being determined by the Economic Development Agency (EDA) to understand the impact of natural disasters on U.S. businesses for the EDA to then guide the Federal Emergency Management Agency (FEMA) and/or policymakers in assisting in economic recovery support missions.
The BTOS consists of a set of core questions and supplemental content, when needed. The U.S. Census Bureau requests approval to add one question on Work from Home (WFH) schedules to the BTOS core content. Data collection for the BTOS core content will start August 12, 2024.
For 2024, the supplemental questionnaire will ask respondents about the business perspective on WFH. Using the same strategy as the 2023 BTOS AI core questions, the Census Bureau hopes to field one core WFH question to run during all cycles in addition to the supplement. The core WFH question will be a yes/no question intended to capture potential seasonality in WFH at the business level. Having this baseline will be important in understanding potential seasonal patterns picked up in the supplemental questions; preliminary findings from cognitive testing suggested that seasonality could be important in certain industries.
The Census Bureau plans to resubmit this package once cognitive testing concludes to gain approval for the WFH supplement which we plan to field
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to Kumar Industries, India (Kumar), a producer and exporter of glycine from India during the period of review (POR) January 1, 2022, through December 31, 2022. Interested parties are invited to comment on these preliminary results.
Applicable July 5, 2024.
Scarlet Jaldin or Amber Hodak AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4275 or (202) 482-8034, respectively.
On June 21, 2019, Commerce published the countervailing duty (CVD) order on glycine from India.
For a complete description of the events that followed the initiation of this review,
The merchandise covered by the
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party or parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. Between June 28 and 30, 2023, Commerce received timely requests for administrative reviews of 31 producers/exporters from various interested parties, in accordance with section 751(a)(1) of the Act and 19 CFR 351.213(b)(1).
Commerce is conducting this administrative review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found to be countervailable, we preliminarily determine that there is a subsidy,
As a result of this review, Commerce preliminary determines the following countervailable subsidy rate for the period January 1, 2022, through December 31, 2022:
We intend to disclose the calculations performed for these preliminary results to interested parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Case briefs or other written documents may be submitted to the Assistant Secretary for Enforcement and Compliance.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, filed electronically via ACCESS. Hearing requests should contain the party's name, address, and telephone number, the number of participants, and a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. An electronically-filed hearing request must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time, within 30 days after the date of publication of this notice. If a request for a hearing is made, parties will be notified of the time and date of the hearing.
Consistent with section 751(a)(1) of the Act and 19 CFR 351.212(b)(2), upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP regarding mandatory respondent, Kumar, no earlier than 35 days after the date of publication of the final results of this review in the
For the companies rescinded from this review, as identified in Appendix II, Commerce will instruct CBP to assess countervailing duties on all appropriate entries at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption during period January 1, 2022, through December 31, 2022, in accordance with 19 CFR 351.212(c)(1)(i). For these companies, Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these preliminary results of review in the
Pursuant to section 751(a)(1) of the Act, upon publication of the final results, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties for each of the companies listed above on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, except where the rate calculated in the final results is zero or
Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2), Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues by the parties in any written briefs, no later than 120 days after the date of publication of these preliminary results.
These preliminary results are being issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) is conducting an administrative review of the antidumping duty order on certain cold-drawn mechanical tubing of carbon and alloy steel (cold-drawn mechanical tubing) from India for the period of review (POR) June 1, 2022, through May 31, 2023. Commerce preliminarily finds that Goodluck India Limited (Goodluck) and Tube Products of India, Ltd., a unit of Tube Investments of India Limited (TII) made sales of subject merchandise at prices below normal value (NV) during the POR. We invite interested parties to comment on these preliminary results.
Applicable July 5, 2024.
Alice Maldonado or Colin Thrasher, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington DC 20230; telephone: (202) 482-4682 or (202) 482-3004, respectively.
On August 3, 2023, Commerce initiated an administrative review of the antidumping duty order on cold-drawn mechanical tubing from India,
The merchandise subject to the
Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Act. We calculated export price in accordance with section 772(a) of the Act. We calculated NV in accordance with section 773 of the Act.
For a full description of the methodology underlying these preliminary results,
We preliminarily determine that the following estimated weighted-average dumping margins exist for the period June 1, 2022, through May 31, 2023:
We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results or, if there is no public announcement, within five days of the date of publication of this notice.
As provided in section 782(i)(3)(B) of the Act and 19 CFR 351.307(b)(1)(iv), Commerce intends to verify the information provided by Goodluck prior to the final results of this administrative review.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their briefs that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS,
Upon completion of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Goodluck or TII for which the company did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be equal to the weighted-average dumping margins established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent
Commerce is issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h)(2) and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that Ban Me Thout Honeybee Joint Stock Company (BMT), Daklak Honeybee Joint Stock Company (DakHoney), and 13 non-individually examined and separate-rate eligible exporters of raw honey from the Socialist Republic of Vietnam (Vietnam) sold subject merchandise to the United States at less than normal value (NV) during the period of review (POR) August 25, 2021, through May 31, 2023.
Applicable July 5, 2024.
Krisha Hill or Stephanie Trejo, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4037 or (202) 482-4390, respectively.
On June 10, 2022, Commerce published in the
On August 3, 2023, Commerce published in the
On January 29, 2024, Commerce extended the deadline for these preliminary results to June 28, 2024.
The product covered by this
A full description of the scope of the
The Act and Commerce's regulations do not address the establishment of a separate rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for separate-rate respondents which Commerce did not examine individually in an administrative review. Section 735(c)(5)(A) of the Act states that the all-others rate should be calculated by averaging the weighted-average dumping margins calculated for individually-examined respondents, excluding dumping margins that are zero,
Under Commerce's policy regarding the conditional review of the Vietnam-wide entity,
With the exception of BMT, DakHoney, and the companies listed in Appendix II, Commerce considers all other companies for which a review was requested and did not demonstrate separate rate eligibility to be part of the Vietnam-wide entity.
Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). We calculated export price and constructed export price in accordance with section 772 of the Act. Because Vietnam is a non-market economy country within the meaning of section 771(18) of the Act, we calculated NV in accordance with section 773(c) of the Act. For a full description of the methodology underlying our conclusions,
Commerce preliminarily determines that the following weighted-average dumping margins exist for the administrative review covering the period August 25, 2021, through May 31, 2023:
We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results or, if there is no public announcement, within five days of the date of publication of this notice.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their briefs that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS.
As provided in section 782(i)(3) of the Act, Commerce intends to verify the information submitted by BMT and DakHoney in advance of the final results of this review.
Unless the deadline is extended, Commerce intends to issue the final results of this review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h).
Upon issuing the final results, Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
For each individually examined respondent in this review whose weighted-average dumping margin in the final results of review is not zero or
Pursuant to Commerce's refinement to its practice, for sales that were not reported in the U.S. sales database submitted by a respondent individually examined during this review, Commerce will instruct CBP to liquidate the entry of such merchandise at the dumping margin assigned to the Vietnam-wide entity.
Additionally, where Commerce determines that an exporter under review had no shipments of subject merchandise to the United States during the POR, any suspended entries of subject merchandise that entered under that exporter's CBP case number during the POR will be liquidated at the dumping margin assigned to the Vietnam-wide entity.
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated antidumping duties, where applicable.
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) for the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margins established in the final results of this review, except if the rate is
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
Commerce is issuing and publishing the preliminary results of this review in accordance with sections 751(a)(1)(B) and 777(i) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of certain pea protein (pea protein) from the People's Republic of China (China). The period of investigation is January 1, 2022, through December 31, 2022.
Applicable July 5, 2024.
Kristen Johnson or Laura Griffith, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4793 or (202) 482-6430, respectively.
On December 18, 2023, Commerce published its
The product covered by this investigation is pea protein from China. For a complete description of the scope of this investigation,
On February 7, 2024, Commerce issued a Preliminary Scope Decision Memorandum in which it determined not to modify the language of the scope as it regards pea protein from China.
The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs that were submitted by parties in this investigation, are discussed in the Issues and Decision Memorandum. For a list of the issues raised by interested parties and addressed in the Issues and Decision Memorandum,
Commerce conducted this investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, Commerce determines that there is a subsidy,
In making this final determination, Commerce relied, in part, on facts otherwise available, including with an adverse inference, pursuant to sections 776(a) and (b) of the Act. For a full discussion of our application of adverse facts available,
Commerce was unable to conduct on-site verifications of the information relied on in making its final determination in this investigation. However, in January 2024, we took additional steps in lieu of on-site verifications to verify the information relied upon in making this final determination, in accordance with section 782(i) of the Act, by conducting virtual verifications of Yantai Oriental Protein Tech Co., Ltd. (Yantai Oriental) and Zhaoyuan Junbang Trading Co., Ltd. (Junbang).
Based on our analysis of the comments received from interested parties and our verification findings, we made certain changes to the subsidy rate calculations for Junbang and Yantai Oriental. For a discussion of these changes,
Pursuant to sections 705(a)(2), 776(a), and 776(b) of the Act, and 19 CFR 351.206, Commerce continues to find that critical circumstances exist with respect to imports of pea protein from China for Junbang, Yantai Oriental, all other producers and/or exporters, and the non-responsive companies. For
Pursuant to section 705(c)(5)(A)(i) of the Act, Commerce will determine an all-others rate equal to the weighted-average countervailable subsidy rates established for exporters and/or producers individually examined, excluding any rates that are zero,
Commerce determines that the following estimated countervailable subsidy rates exist:
Commerce intends to disclose to interested parties the calculations and analysis performed in this final determination within five days of any public announcement or, if there is no public announcement, within five days of the date of the publication of this notice in the
As a result of our
If the U.S. International Trade Commission (ITC) issues a final affirmative injury determination, we will issue a countervailing duty order, reinstate the suspension of liquidation under section 706(a) of the Act, and require a cash deposit of estimated countervailing duties for entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated, and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our final affirmative determination that countervailable subsidies are being provided to producers and exporters of pea protein from China. Because the final determination is affirmative, in accordance with section 705(b) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of pea protein from China no later than 45 days after our final determination. In addition, we are making available to the ITC all non-privileged and nonproprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance. If the ITC determines that material injury or threat of material injury does not exist, this proceeding will be terminated and all cash deposits will be refunded. If the ITC determines that such injury does exist, Commerce will issue a countervailing duty order directing CBP to assess, upon further instruction by Commerce, countervailing duties on all imports of the subject merchandise that are entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO, in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act, and 19 CFR 351.210(c).
The product within the scope of this investigation is high protein content (HPC) pea protein, which is a protein derived from peas (including, but not limited to, yellow field peas and green field peas) and which contains at least 65 percent protein on a dry weight basis. HPC pea protein may also be identified as, for example, pea protein concentrate, pea protein isolate, hydrolyzed pea protein, pea peptides, and fermented pea protein. Pea protein, including HPC pea protein, has the Chemical Abstracts Service (CAS) registry number 222400-29-5.
The scope covers HPC pea protein in all physical forms, including all liquid (
The scope also includes HPC pea protein described above that is blended, combined, or mixed with non-subject pea protein or with other ingredients (
HPC pea protein that is otherwise within the scope is covered when commingled (
A blend, combination, or mixture is excluded from the scope if the total HPC pea protein content of the blend, combination, or mixture (regardless of the source or sources) comprises less than five percent of the blend, combination, or mixture on a dry weight basis.
All products that meet the written physical description are within the scope of the investigation unless specifically excluded. The following products, by way of example, are outside and/or specifically excluded from the scope of the investigation:
• burgers, snack bars, bakery products, sugar and gum confectionary products, milk, cheese, baby food, sauces and seasonings, and pet food, even when such products are made with HPC pea protein.
• HPC pea protein that has gone through an extrusion process to alter the HPC pea protein at the structural and functional level, resulting in a product with a fibrous structure which resembles muscle meat upon hydration. These products are commonly described as textured pea protein or texturized pea protein.
• HPC pea protein that has been further processed to create a small crunchy nugget commonly described as a pea protein crisp.
• protein derived from chickpeas.
The merchandise covered by the scope is currently classified under Harmonized Tariff Schedule of the United States (HTSUS) categories 3504.00.1000, 3504.00.5000, and 2106.10.0000. Such merchandise may also enter the U.S. market under HTSUS category 2308.00.9890. Although HTSUS categories and the CAS registry number are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that certain pea protein (pea protein) from the People's Republic of China (China) is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation is January 1, 2023, through June 30, 2023.
Applicable July 5, 2024.
Sofia Pedrelli or Katherine Smith, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4310 or (202) 482-0557, respectively.
On February 13, 2024, Commerce published its
For a summary of the events that occurred since the
The product covered by this investigation is pea protein from China. For a complete description of the scope of this investigation,
On February 7, 2024, Commerce issued a Preliminary Scope Decision Memorandum in which it determined not to modify the language of the scope as it regards pea protein from China.
We continue to find that critical circumstances exist for imports of pea protein from China for the separate rate companies and the China-wide entity,
All issues raised in the case and rebuttal briefs submitted by interested parties are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is attached as appendix II to this notice.
Consistent with the
We preliminarily found certain companies to be eligible for a separate rate in the
In calculating the rate for non-individually examined separate rate respondents in a non-market economy LTFV investigation, Commerce normally looks to section 735(c)(5)(A) of the Act, which pertains to the calculation of the all-others rate in a market economy LTFV investigation, for guidance. Pursuant to section 735(c)(5)(A) of the Act, normally this rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for those companies individually examined, excluding any margins that are zero,
The estimated weighted-average dumping margins in this final determination are based entirely under section 776 of the Act. In investigations where no estimated weighted-average dumping margins other than zero,
Consistent with the
The final estimated weighted-average dumping margins are as follows:
Normally, Commerce discloses to interested parties the calculations performed in connection with a final determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because Commerce continues to find the mandatory respondents are part of the China-wide entity, applied total AFA to the China-wide entity in this investigation in accordance with section 776 of the Act, and the applied AFA rate is based solely on the petition, there are no calculations to disclose.
In accordance with section 735(c)(4) of the Act, because Commerce continues to find that critical circumstances exist for the non-selected separate rate companies and the China-wide entity, we will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of subject merchandise, as described in Appendix I of this notice, entered, or withdrawn from warehouse, for consumption, on or after November 15, 2023, which is 90 days prior to the date of publication of the affirmative
To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion countervailing duty (CVD) proceeding when CVD provisional measures are in effect. Accordingly, where Commerce makes an affirmative determination for domestic subsidy pass-through or export subsidies, Commerce offsets the calculated estimated weighted-average dumping margin by the appropriate rates. However, suspension of liquidation of provisional measures in the companion CVD investigation has been discontinued; therefore, we are not instructing CBP to collect cash deposits based upon the adjusted estimated weighted-average dumping margin for those export subsidies at this time.
Pursuant to section 735(c)(1)(B)(ii) of the Act and 19 CFR 351.210(d), we will instruct CBP to require a cash deposit for such entries of merchandise equal to the amount by which the normal value exceeds the U.S. price as follows: (1) for the producer/exporter combinations listed in the table above, the cash deposit rate is equal to the estimated weighted-average dumping margin listed for that combination in the table; (2) for all combinations of Chinese producers/exporters of subject merchandise that have not established eligibility for their own separate rates, the cash deposit rate will be equal to the estimated weighted-average dumping margin established for the China-wide entity; and (3) for all third country exporters of subject merchandise not listed in the table above, the cash deposit rate is the cash deposit rate applicable to the Chinese producer/exporter combination (or China-wide entity) that supplied that third-country exporter. These suspension of liquidation instructions will remain in effect until further notice.
In accordance with section 735(d) of the Act, we will notify the ITC of our final affirmative determination of sales at LTFV. Because the final determination in this proceeding is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of pea protein from China no later than 45 days after this final determination. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all cash deposits will be refunded or canceled, and suspension of liquidation will be lifted. If the ITC determines that such injury does exist, Commerce will issue an antidumping duty order directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise that are entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
This notice will serve as the final reminder to the parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This determination and this notice are issued and published in accordance with sections 735(d) and 777(i)(1) of the Act, and 19 CFR 351.210(c).
The product within the scope of this investigation is high protein content (HPC) pea protein, which is a protein derived from peas (including, but not limited to, yellow field peas and green field peas) and which contains at least 65 percent protein on a dry weight basis. HPC pea protein may also be identified as, for example, pea protein concentrate, pea protein isolate, hydrolyzed pea protein, pea peptides, and fermented pea protein. Pea protein, including HPC pea protein, has the Chemical Abstracts Service (CAS) registry number 222400-29-5.
The scope covers HPC pea protein in all physical forms, including all liquid (
The scope also includes HPC pea protein described above that is blended, combined, or mixed with non-subject pea protein or with other ingredients (
HPC pea protein that is otherwise within the scope is covered when commingled (
A blend, combination, or mixture is excluded from the scope if the total HPC pea protein content of the blend, combination, or mixture (regardless of the source or sources) comprises less than five percent of the blend, combination, or mixture on a dry weight basis.
All products that meet the written physical description are within the scope of the investigation unless specifically excluded. The following products, by way of example, are outside and/or specifically excluded from the scope of the investigation:
• burgers, snack bars, bakery products, sugar and gum confectionary products, milk, cheese, baby food, sauces and seasonings, and pet food, even when such products are made with HPC pea protein;
• HPC pea protein that has gone through an extrusion process to alter the HPC pea protein at the structural and functional level, resulting in a product with a fibrous structure which resembles muscle meat upon hydration. These products are commonly described as textured pea protein or texturized pea protein;
• HPC pea protein that has been further processed to create a small crunchy nugget commonly described as a pea protein crisp;
• protein derived from chickpeas.
The merchandise covered by the scope is currently classified under Harmonized Tariff Schedule of the United States (HTSUS) categories 3504.00.1000, 3504.00.5000, and 2106.10.0000. Such merchandise may also enter the U.S. market under HTSUS category 2308.00.9890. Although HTSUS categories and the CAS registry number are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) has determined that Shenzhen Sungold Solar Co., Ltd. (Sungold), and the companies to which Commerce granted separate rates, did not sell subject merchandise at prices below normal value (NV) during the period December 1, 2021, through November 30, 2022, the period of review (POR). Commerce also determined that certain companies do not qualify for a separate rate, and that it is appropriate to rescind this review with respect to certain companies that did not ship subject merchandise during the POR.
Applicable July 5, 2024.
Dakota Potts or Paola Aleman Ordaz, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0223 or (202) 482-4031, respectively.
On January 4, 2024, Commerce published the
The merchandise covered by the
We addressed all the issues raised in interested parties' case and rebuttal briefs in the Issues and Decision Memorandum. A list of the issues raised
Based on our analysis of the comments received, and for the reasons explained in the Issues and Decision Memorandum, we revised the surrogate value of the EVA input used by Sungold.
In the
In the
No parties commented on Commerce's preliminary no shipments determination
With the exception of Commerce's decision to deny Yingli
The statute and Commerce's regulations do not address what dumping margin to apply to respondents that are not selected for individual examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the dumping margin for respondents that are not individually examined in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero and
Commerce determines that the following weighted-average dumping margins exist for the period December 1, 2021, through November 30, 2022:
Commerce intends to disclose to parties to the proceeding the
Because the weighted average dumping margins for the companies that are listed in the table in the “Final Results of Review” section of this notice are zero percent, Commerce will instruct CBP to liquidate entries of the companies' subject merchandise during the POR without regard to antidumping duties. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of this notice in the
Pursuant to a refinement of its practice, Commerce will instruct CBP to liquidate entries of Sungold's subject merchandise for which sales were not reported in the U.S. sales database at the China-wide entity rate.
Additionally, Commerce will instruct CBP to liquidate entries of subject merchandise during the POR that were recorded under the company-specific case numbers for Trina Solar Changzhou or Jinko Solar at the China-wide entity rate.
The following cash deposit requirements will be in effect for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on, or after, the date of publication of this notice in the
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant POR entries. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties has occurred and the subsequent assessment of doubled antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing these final results of administrative review and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213(h)(2) and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that certain producers and/or exporters subject to this administrative review did not make sales of subject merchandise at less than normal value during the period of review (POR) June 1, 2022, through May 31, 2023. Interested parties are invited to comment on these preliminary results.
Applicable July 5, 2024.
Peter K. Farrell or Tyler R. Weinhold, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2104 or (202) 482-1121, respectively.
On June 21, 2019, Commerce published in the
The product covered by the scope of the
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. Commerce received requests for review from Avid Organics Private Limited (Avid), a producer and exporter of subject merchandise,
Commerce is conducting this review in accordance with section 751(a) of the Act. For a full description of the methodology underlying these preliminary results,
We preliminarily determine that the following weighted-average dumping margin exists for the period June 1, 2022, through May 31, 2023:
Commerce intends to disclose to interested parties its calculations performed in these preliminary results, within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the
Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs or other written comments to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the date of publication of this notice.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this administrative review, we instead request that interested parties provide, at the beginning of their briefs, a public executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
All submissions, including case and rebuttal briefs, as well as hearing requests, should be filed via ACCESS.
Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice in the
Upon completion of this administrative review, pursuant to section 751(a)(2)(A) of the Act, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. If the weighted-average dumping margin for a mandatory respondent is not zero or
For the companies for which we are rescinding this administrative review, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period of review, in accordance with 19 CFR 351.212(c)(1)(i). For these companies, Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these preliminary results in the
Consistent with its recent notice,
The following cash deposit requirements will be effective upon publication in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties, and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping duty (AD) and countervailing duty (CVD) orders with May anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.
Applicable July 5, 2024.
Brenda E. Brown, AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.
Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various AD and CVD orders with May anniversary dates.
All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.
In the event that Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review (POR). We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 35 days of publication of the initiation
In the event that Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Tariff Act of 1930, as amended (the Act), the following guidelines regarding collapsing of companies for purposes of respondent selection will apply. In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (
Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (Q&V) Questionnaire for purposes of respondent selection, in general, each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where Commerce considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.
With respect to AD administrative reviews, we intend to rescind the review where there are no suspended entries for a company or entity under review and/or where there are no suspended entries under the company-specific case number for that company or entity. Where there may be suspended entries, if a producer or exporter named in this notice of initiation had no exports, sales, or entries during the POR, it may notify Commerce of this fact within 30 days of publication of this notice in the
Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.
Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of a particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act.
Neither section 773(e) of the Act nor 19 CFR 351.301(c)(2)(v) set a deadline for the submission of PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of initial responses to section D of the questionnaire.
In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single AD deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both
All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a Separate Rate Application or Certification, as described below.
For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at
Entities that currently do not have a separate rate from a completed segment of the proceeding
Exporters and producers must file a timely Separate Rate Application or Certification if they want to be considered for individual examination. Furthermore, exporters and producers who submit a Separate Rate Application or Certification and subsequently are selected as mandatory respondents will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.
In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following AD and CVD orders and findings. We intend to issue the final results of these reviews not later than May 31, 2025.
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an AD order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), Commerce, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether ADs have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant “gap” period of the order (
Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (
Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information using the formats provided at the end of the
Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by Commerce.
These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that the producer/exporter subject to this administrative review made sales of subject merchandise at prices below normal value (NV) during the period of review (POR), June 1, 2022, through May 31, 2023. We invite interested parties to comment on these preliminary results.
Applicable July 5, 2024.
Lilit Astvatsatrian, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6412.
On June 4, 2021, Commerce published the antidumping duty order on prestressed concrete steel wire strand from Spain in the
For a complete description of the events that followed the initiation of this review,
The products subject to the
Commerce is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). We calculated export price and constructed export price in accordance with section 772 of the Act. We calculated NV in accordance with
As a result of this review, we preliminarily determine the following estimated weighted-average dumping margin exists for the period June 1, 2022, through May 30, 2023:
On November 13, 2023, Insteel Wire Products Company, Sumiden Wire Products Corporation, and Wire Mesh Corp., the petitioners in this proceeding, requested that Commerce conduct verification of the factual information submitted by TYCSA in this administrative review.
We intend to disclose the calculations performed in connection with these preliminary results to interested parties within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in the
Interested parties may submit case briefs to Commerce no later than seven days after the date on which the verification report is issued in this administrative review.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings, we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide, at the beginning of their briefs, a public executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing.
All submissions, including case and rebuttal briefs, as well as hearing requests, should be filed via ACCESS.
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice in the
Upon completion of this administrative review, pursuant to section 751(a)(2)(A) of the Act, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
Pursuant to 19 CFR 351.212(b)(1), we calculated importer-specific
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by TYCSA for which the company did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the less-than-fair-value (LTFV) investigation (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that raw honey from Brazil was sold in the United States at below normal value (NV) during the period of review (POR) November 23, 2021, through May 31, 2023. We are also rescinding the review with respect to certain companies that had no entries of the subject merchandise during the POR. We invite interested parties to comment on these preliminary results.
Applicable July 5, 2024.
Rachel Jennings, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202)-482-1110.
On August 3, 2023, Commerce initiated an administrative review of the antidumping duty order on raw honey from Brazil, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).
On February 14, 2024, Commerce extended the time limit for completing the preliminary results of this review until June 28, 2024.
The product covered by the scope of this
Pursuant to 19 CFR 351.213(d)(3), when there are no reviewable entries of subject merchandise during the POR subject to the antidumping duty order for which liquidation is suspended, Commerce may rescind an administrative review, in whole or only with respect to a particular exporter or producer.
At the end of the administrative review, any suspended entries are liquidated at the assessment rate computed for the review period.
Commerce is conducting this review in accordance with section 751(a) of the Act. We calculated export price and
The Act and Commerce's regulations do not address the establishment of a rate to be applied to companies not selected for examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
In this review, we have preliminarily calculated weighted-average dumping margins of zero percent and 2.31 percent for Apis Nativa and Melbras, respectively. Therefore, in accordance with section 735(c)(5)(A) of the Act, we are preliminarily applying Melbras' weighted-average dumping margin of 2.31 percent to the non-examined companies, because this is the only rate that is not zero,
We preliminarily
Commerce intends to disclose the calculations performed in connection with these preliminary results to interested parties within five days after the date of publication of this notice, or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary, filed electronically via ACCESS.
The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties, where applicable.
Upon completion of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. If a respondent's weighted-average dumping margin is not zero or
For the companies in Appendix III, we will instruct CBP to assess antidumping duties on any suspended entries that entered under their CBP case numbers (
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced Apis Nativa or Melbras for which these companies did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the publication date of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed in the final results of this review will be equal to the weighted-average dumping margin established in the final results of this administrative review except if the rate is less than 0.50 percent and, therefore,
Unless extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).
This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
Commerce is issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
International Trade Administration, U.S. Department of Commerce.
Notice of Federal Advisory Committee meeting.
This notice sets forth the schedule and proposed agenda for a meeting of the Civil Nuclear Trade Advisory Committee (CINTAC).
The meeting is scheduled for Thursday, July 18, 2024, from 10:00 a.m. to 4:00 p.m. Eastern Daylight Time (EDT). The deadline for members of the public to register, including requests to make comments during the meeting and
The meeting will be in-person at the Department of Commerce Herbert C. Hoover Building (1401 Constitution Ave. NW, Washington, DC 20230, Room 1412). Registered participants will be emailed instructions on accessing the designated meeting space. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, International Trade Administration, (email:
Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, International Trade Administration, Room 28018, 1401 Constitution Ave. NW, Washington, DC 20230. (Phone: 202-482-1297; email:
Members of the public wishing to attend the meeting must notify Mr. Jonathan Chesebro at the contact information above by 5:00 p.m. EDT on Monday, July 15, 2024, in order to pre-register. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting.
A limited amount of time will be available for brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 20 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Jonathan Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5:00 p.m. EDT on Monday, July 15, 2024. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, ITA may conduct a lottery to determine the speakers.
Any member of the public may submit written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to Mr. Jonathan Chesebro in the International Trade Administration's Office of Energy & Environmental Industries. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EDT on Monday, July 15, 2024. Comments received after that date will be distributed to the members but may not be considered at the meeting.
Copies of CINTAC meeting minutes will be available within 90 days of the meeting.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable July 5, 2024.
Benjamin Nathan or Gregory Taushani, Office II, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-3834 or (202) 482-1012, respectively.
On May 13, 2024, the U.S. Department of Commerce (Commerce) initiated a countervailing duty (CVD) investigation of imports of certain alkyl phosphate esters from the People's Republic of China. Currently, the preliminary determination is due no later than July 17, 2024.
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On June 21, 2024, the petitioner
In accordance with 19 CFR 351.205(e), the petitioner submitted its request for postponement of the preliminary determination in this investigation 25 days or more before the scheduled date of the preliminary determination and stated the reasons for its request. Commerce finds no
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for emergency review and approval in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden.
Both the NSTC and NAPMP have a need to expeditiously identify facilities in order to accomplish their statutory missions. The NSTC is required to “to conduct advanced semiconductor manufacturing, design and packaging research, and prototyping that strengthens the entire domestic ecosystem.” 15 U.S.C. 4656(c)(2)(A). The NSTC is expected to “significantly reduce the time and cost of moving from design idea to commercialization through access to shared facilities, digital assets and technical expertise for advancing design, prototyping, manufacturing, packaging, and scaling of semiconductors and semiconductor-related products” (
The information collection will take the form of an Ecosystem Questionnaire for States and Territories to Inform CHIPS R&D Facility Site Selection Process. The Questionnaire will pose identical questions to Economic Development Organizations (EDOs) in all 56 states and territories. This collection is subject to the Paperwork Reduction Act as the RFI would pose identical questions to all 56 states and territories. See 5 CFR 1320.3(c)(4) and (k)). The Ecosystem Questionnaire will request information regarding the extent to which a state or territory can demonstrate: the presence of entities from the semiconductor value chain; a semiconductor workforce and current workforce development programs; semiconductor-related advanced education and research programs; significant state, local, and private investment in the semiconductor ecosystem; and state incentives for semiconductor research and development. The Ecosystem Questionnaire is also structured to be as minimally burdensome as possible, both because responses are predominantly requested in the form of multiple-choice answers, and because the information the Questionnaire solicits should be easily available to EDOs. This will be a one-time collection of information to all 56 states and territories. Only states or territories that submit responses to the Ecosystem Questionnaire will be considered for selection of this facility.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should by 11:59 p.m. EST on July 12, 2024 on the following website
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; affirmative finding annual renewals for Ecuador, El Salvador, Guatemala, Mexico, Peru, and Spain.
The NMFS Assistant Administrator (Assistant Administrator) has completed an affirmative finding annual renewal for the Governments of Ecuador, El Salvador, Guatemala, Mexico, Peru, and Spain (referred to hereafter as “The Nations”) under the portions of the Marine Mammal Protection Act (MMPA) related to the eastern tropical Pacific Ocean (ETP) tuna purse seine fishery and the importation of yellowfin tuna from nations participating in this fishery. These affirmative findings will continue to allow the importation into the United States of yellowfin tuna and yellowfin tuna products harvested in the ETP for 1 year, in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP), by purse seine vessels operating under The Nations' jurisdiction or exported from The Nations. NMFS bases the affirmative finding annual renewals on reviews of documentary evidence submitted by the Governments of The Nations and of information obtained from the Inter-American Tropical Tuna Commission (IATTC).
These affirmative finding annual renewals are effective for the 1-year period of April 1, 2024, through March 31, 2025.
Justin Greenman, West Coast Region, NMFS, by mail: 501 W Ocean Blvd., Suite 4200, Long Beach, CA 90802, email:
The MMPA, 16 U.S.C. 1361
The affirmative finding process requires that the harvesting nation is meeting its obligations under the AIDCP and its obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS must determine whether the harvesting nation continues to meet the requirements of their 5-year affirmative finding. NMFS does this by reviewing the documentary evidence from the last year. A nation may provide information related to compliance with AIDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.
An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the AIDCP.
As a part of the affirmative finding process set forth in 50 CFR 216.24(f)(8), for this annual renewal, the Assistant Administrator considered documentary evidence submitted by the Governments of The Nations and obtained from the IATTC and has determined that The Nations have met the MMPA's requirements to receive affirmative finding annual renewals.
After consultation with the Department of State, the Assistant Administrator issued affirmative finding annual renewals to The Nations, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by purse seine vessels operating under The Nations' jurisdiction or exported from The Nations. Issuance of affirmative finding annual renewals for The Nations does not affect implementation of an intermediary nation embargo under 50 CFR 216.24(f)(9), which applies to exports from a nation that exports to the United States yellowfin tuna or yellowfin tuna products that was subject to a ban on importation into the United States under section 101(a)(2)(B) of the MMPA, 16 U.S.C. 1371(a)(2)(B).
These affirmative finding annual renewals for The Nations are for the 1-year period of April 1, 2024, through March 31, 2025. The Nations' individual 5-year affirmative findings, which have varying start and end dates, remain valid. El Salvador's 5-year affirmative finding will remain valid through March 31, 2028. Peru's 5-year affirmative findings will remain valid through March 31, 2027. Ecuador, Guatemala, Mexico, and Spain's 5-year affirmative findings will remain valid through March 31, 2025, subject to subsequent annual reviews by NMFS.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; new 5-year affirmative finding for Colombia.
The NMFS Assistant Administrator (Assistant Administrator) has issued a new 5-year affirmative finding for the Government of Colombia under the portions of the Marine Mammal Protection Act (MMPA) related to the eastern tropical Pacific Ocean (ETP) tuna purse seine fishery and the importation of yellowfin tuna from nations participating in this fishery. This affirmative finding will allow the importation into the United States of yellowfin tuna and yellowfin tuna products harvested in the ETP, in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP), by purse seine vessels operating under Colombia's jurisdiction or exported from Colombia. NMFS bases the affirmative finding determination on reviews of documentary evidence submitted by the Government of Colombia and of information obtained from the Inter-American Tropical Tuna Commission (IATTC).
This new affirmative finding is effective for the 5-year period of April 1, 2024, through March 31, 2029.
Justin Greenman, West Coast Region, NMFS, by mail: 501 W Ocean Blvd., Suite 4200, Long Beach, CA 90802, email:
The MMPA, 16 U.S.C. 1361
The affirmative finding process requires that the harvesting nation is meeting its obligations under the AIDCP and its obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS must determine whether the harvesting nation continues to meet the requirements of their 5-year affirmative finding. NMFS does this by reviewing the documentary evidence from the last year. A nation may provide information related to compliance with AIDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.
An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the AIDCP.
As a part of the affirmative finding process set forth in 50 CFR 216.24(f)(8), the Assistant Administrator considered documentary evidence submitted by the Government of Colombia and obtained from the IATTC, and has determined that Colombia has met the MMPA's requirements to receive a new 5-year affirmative finding.
After consultation with the Department of State, the Assistant Administrator issued a new 5-year affirmative finding to Colombia, allowing the importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by purse seine vessels operating under Colombia's jurisdiction or exported from Colombia. Issuance of a new 5-year affirmative finding for Colombia does not affect implementation of an intermediary nation embargo under 50 CFR 216.24(f)(9), which applies to exports from a nation that exports to the United States yellowfin tuna or yellowfin tuna products that was subject to a ban on importation into the United States under section 101(a)(2)(B) of the MMPA, 16 U.S.C. 1371(a)(2)(B).
This new affirmative finding for Colombia is for the 5-year period of April 1, 2024, through March 31, 2029, subject to subsequent annual reviews by NMFS.
United States Patent and Trademark Office, U.S. Department of Commerce.
Notice of public listening session.
The United States Patent and Trademark Office (USPTO) plays an important role in incentivizing and protecting innovation, including innovation enabled by artificial intelligence (AI), to ensure continued U.S. leadership in AI and other emerging technologies (ET). On April 30, 2024, the USPTO published a request for comments (RFC) in the
The Listening Session on the Impact of Proliferation of AI on Prior Art and PHOSITA will be held on July 25, 2024, from 10:00 a.m. to 3:00 p.m. ET. Persons seeking to speak at the listening session, either virtually or in person, must register by 8:00 p.m. ET on July 19, 2024, at the website provided in the
Register to speak or attend the listening session at
The public meeting will be physically accessible to people with disabilities. Individuals requiring accommodation, such as sign language interpretation or other ancillary aids, should communicate their needs to an individual listed under the
Srilakshmi Kumar, Senior Advisor, Office of the Under Secretary, 571-272-7769, or Aleksandr Kerzhner, Supervisory Patent Examiner, 571-270-1760. You can also send inquiries to
To continue its support for the National AI Initiative Act of 2020, which became law on January 1, 2021, the USPTO announced in June 2022 the formation of the AI/ET Partnership, which provides an opportunity to bring stakeholders together through a series of engagements to share ideas, feedback, experiences, and insights on the intersection of intellectual property and AI/ET. To build on the AI/ET Partnership efforts and the USPTO's recent AI-related efforts associated with Executive Order 14110,
The USPTO will hold a public listening session virtually and in person at the USPTO Headquarters in Alexandria, Virginia, on July 25, 2024.
Requests to participate as a speaker must include:
1. The name of the person desiring to participate;
2. The organization(s) that person represents, if any;
3. Contact information (zip code, telephone number, and email address);
4. Information on the specific topic or question(s) from the RFC of interest to the speaker (or their organization); and
5. A summary of comments to be articulated during the listening session (discussed further below).
Speaking slots are limited; preference will be given to speakers based on the specific topic or question(s) provided in the request to participate. Selected speakers may be grouped by topic. Topics and speakers will be announced a few days prior to the event and listening session. Speakers may attend virtually or in person and are required to submit their remarks for the listening session in advance through the Federal eRulemaking Portal at
Each speaker will be informed of their assigned time slot in advance. Time slots will be at least three minutes, but may be longer, depending on the number of speakers registered. USPTO personnel may reserve time to ask questions of particular speakers after the delivery of a speaker's remarks.
The purpose of the listening session is to obtain public input from a broad group of stakeholders regarding the impact of the proliferation of AI on prior art and PHOSITA, as set forth in the questions for public comment of the RFC.
We encourage interested speakers to address the questions posed in the RFC and to submit research and data, if any, that inform their comments on these questions. Official written comments to the questions raised in the RFC should be submitted as outlined in the RFC. For convenience, a copy of the questions from the RFC is provided below in their entirety.
1. In what manner, if any, does 35 U.S.C. 102 presume or require that a prior art disclosure be authored and/or published by humans? In what manner, if any, does non-human authorship of a disclosure affect its availability as prior art under 35 U.S.C. 102?
2. What types of AI-generated disclosures, if any, would be pertinent to patentability determinations made by the USPTO? How are such disclosures currently being made available to the public? In what other ways, if any, should such disclosures be made available to the public?
3. If a party submits to the Office a printed publication or other evidence that the party knows was AI-generated, should that party notify the USPTO of this fact, and if so, how? What duty, if any, should the party have to determine whether a disclosure was AI-generated?
4. Should an AI-generated disclosure be treated differently than a non-AI-generated disclosure for prior art purposes? For example:
a. Should the treatment of an AI-generated disclosure as prior art depend on the extent of human contribution to the AI-generated disclosure?
b. How should the fact that an AI-generated disclosure could include incorrect information (
c. How does the fact that a disclosure is AI-generated impact other prior art considerations, such as operability, enablement, and public accessibility?
5. At what point, if ever, could the volume of AI-generated prior art be sufficient to create an undue barrier to the patentability of inventions? At what point, if ever, could the volume of AI-generated prior art be sufficient to detract from the public accessibility of prior art (
6. Does the term “person” in the PHOSITA assessment presume or require that the “person” is a natural person,
7. How, if at all, should the USPTO determine which AI tools are in common use and whether these tools are presumed to be known and used by a PHOSITA in a particular art?
8. How, if at all, does the availability to a PHOSITA of AI as a tool impact:
a. Whether something is well-known or common knowledge in the art?
b. How a PHOSITA would understand the meaning of claim terms?
9. In view of the availability to a PHOSITA of AI as a tool, how, if at all, is an obviousness determination affected, including when:
a. Determining whether art is analogous to the claimed invention, given AI's ability to search across art fields? Does the “analogous” art standard still make sense in view of AI's capabilities?
b. Determining whether there is a rationale to modify the prior art, including the example rationales suggested by
c. Determining whether the modification yields predictable results with a reasonable expectation of success (
d. Evaluating objective indicia of obviousness or nonobviousness (
10. How, if at all, does the recency of the information used to train an AI model or that ingested by an AI model impact the PHOSITA assessment when that assessment may focus on an earlier point in time (
11. How, if at all, does the availability to a PHOSITA of AI as a tool impact the enablement determination under 35 U.S.C. 112(a)? Specifically, how does it impact the consideration of the
12. What guidance from the USPTO on the impact of AI on prior art and on the knowledge of a PHOSITA, in connection with patentability determinations made by the Office, would be helpful?
13. In addition to the considerations discussed above, in what other ways, if any, does the proliferation of AI impact patentability determinations made by the Office (
14. Are there any laws or practices in other countries that effectively address any of the questions above? If so, please identify them and explain how they can be adapted to fit within the framework of U.S. patent law.
15. Should title 35 of the U.S. Code be amended to account for any of the considerations set forth in this notice, and if so, what specific amendments do you propose, and why?
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed deletions from the Procurement List.
The Committee is proposing to delete service(s) to the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 355 E Street SW, Suite 325, Washington, DC 20024.
For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 489-1322 or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
The following service(s) are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 355 E Street SW, Suite 325, Washington, DC 20024.
Michael R. Jurkowski, Telephone: (703) 489-1322, or email
On 4/12/2024 (89 FR 25867) and 5/24/2024 (89 FR 45859), the Committee for Purchase From People Who Are Blind or Severely Disabled (operating as the U.S. AbilityOne Commission) published an initial notice of proposed additions to the Procurement List. The Committee determined that the service(s) listed below are suitable for procurement by the Federal Government and has added these service(s) to the Procurement List as a mandatory purchase for contracting activities listed. In accordance with 41 CFR 51-5.3(b), the mandatory purchase requirement is limited to those contracting activities at the locations listed, and in accordance with 41 CFR 51-5.2, the Committee has authorized nonprofit agencies listed as the authorized source(s) of supply.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the service(s) listed below are suitable for procurement by
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the service(s) to the Government.
2. The action will result in authorizing small entities to furnish the service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service(s) proposed for addition to the Procurement List.
Accordingly, the following service(s) are added to the Procurement List:
The Committee finds good cause to dispense with the 30-day delay in the effective date normally required by the Administrative Procedure Act. See 5 U.S.C. 553(d). This addition to the Committee's Procurement List is effectuated because of the expiration of the DEPT OF THE ARMY, W39L USA NG READINESS CENTER contract. The Federal customer contacted and has worked diligently with the AbilityOne Program to fulfill this service need under the AbilityOne Program. To avoid performance disruption, and the possibility that the DEPT OF THE ARMY, W39L USA NG READINESS CENTER will refer its business elsewhere, this addition must be effective on 7/14/2024, ensuring timely execution for a 7/16/2024 start date while still allowing nine (9) days for comment. The Committee also published a notice of proposed Procurement List addition in the
9:00 a.m. EDT, Friday, July 12, 2024.
Virtual meeting.
Closed.
Enforcement matters. In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
Christopher Kirkpatrick, 202-418-5964.
Environmental Protection Agency (EPA).
Notice of meeting.
Pursuant to the Federal Advisory Committee Act (FACA), the U.S. Environmental Protection Agency (EPA) hereby provides notice that the National Environmental Youth Advisory Council (NEYAC) will meet on the date and time described below. The meeting is open to the public. For additional information about registering to attend the meeting or to provide a public comment, see the “Public Participation” heading of the
The NEYAC will convene a virtual public meeting on Wednesday, July 17, 2024. A public comment period relevant to the NEYAC will be considered by the NEYAC at the meeting (see
You may send comments, identified by Docket ID No. EPA-HQ-OA-2024-0043, by any of the following methods:
•
•
The virtual meeting will be through an online audio and video platform. The meeting will convene on Wednesday, July 17, from 12 p.m. to 4:30 p.m. eastern time. Refer to the
Carissa Cyran, NEYAC Designated Federal Officer (1702A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1353; email address:
The NEYAC has been deliberating on the following issues and will discuss and vote on recommendations at this meeting.
Topic 1: Environmental Justice and Youth.
Topic 2: Office of Air and Radiation: Climate, Clean Air, and Environmental Justice.
Topic 3: Addressing Food Waste at Home and Abroad: A Case for Circular and Sustainable Materials Management Systems.
Read the charge memos and presentations here:
Individual registration is required for the public meeting. No two individuals can share the same registration link. Information on how to register is located at
Submit your comments, identified by Docket ID No. EPA-HQ-OA-2024-0043, at
The NEYAC will hear comments from the public from approximately 2:35 p.m.-3:05 p.m. eastern time. EPA will begin pre-registering speakers for the public meeting upon publication of this document in the
Time will be allotted on a first-come first-served basis, and the total period for comments may be extended if the number of requests for appearances requires it. EPA will make every effort to follow the schedule as closely as possible on the day of the public meeting; however, please plan for the meeting to run either ahead of schedule or behind schedule.
Individuals or groups making remarks during the public comment period will be limited to two (2)—three (3) minutes. Please be prepared to briefly describe your issue and your recommendation relevant to the current charges, topics, and questions under consideration by the NEYAC. EPA also recommends submitting the text of your oral comments as written comments to the rulemaking docket.
Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public meeting.
Please note that any updates made to any aspect of the public meeting are posted online at
To request special accommodations for a disability or other assistance, please submit your request at least five (5) working days prior to the meeting to give EPA sufficient time to process your request. All requests should be sent to the email listed in the
Environmental Protection Agency (EPA).
Notice.
The Toxic Substances Control Act (TSCA) requires EPA to publish in the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0159, is available online at
This action provides information that is directed to the public in general.
This document lists the statements of findings made by EPA after review of submissions under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the reporting period.
TSCA section 5(a)(3) requires EPA to review a submission under TSCA section 5(a) and make one of several specific findings pertaining to whether the substance may present unreasonable risk of injury to health or the environment. Among those potential findings is that the chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment per TSCA Section 5(a)(3)(C).
TSCA section 5(g) requires EPA to publish in the
Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.
The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.
No.
In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:
The following list provides the EPA case number assigned to the TSCA section 5(a) submission and the chemical identity (generic name if the specific name is claimed as CBI).
• P-23-0129, Benzyl fatty acid esters (Generic Name).
• P-23-0062, Cashew, nutshell., polymer-based polyether polyol (Generic Name).
• J-24-0009-0013, Chromosomally modified
To access EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section
10 a.m., Thursday, July 11, 2024.
You may observe this meeting in person at 1501 Farm Credit Drive, McLean, Virginia 22102-5090, or virtually. If you would like to observe, at least 24 hours in advance, visit
This meeting will be open to the public.
The following matters will be considered:
If you need more information or assistance for accessibility reasons, or have questions, contact Ashley Waldron, Secretary to the Board. Telephone: 703-883-4009. TTY: 703-883-4056.
The Commission hereby gives notice of filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreements to the Secretary by email at
Office of Acquisition Policy, General Services Administration (GSA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, GSA invites the public to comment on a request to review and approve an extension of a previously approved information collection requirement regarding contractor qualifications and financial information.
Submit comments on or before: September 3, 2024.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
•
Mr. Bryon Boyer, Procurement Analyst, at
GSA requires prospective contractors to submit certain financial information for a contracting officer to make a determination that it is financially responsible for an award, in accordance with the Federal Acquisition Regulation (FAR) 9.103(a) and 9.104-1 and also the General Services Administration Acquisition Manual (GSAM) 509.105-1(a). GSA Form 527, Contractor's Qualifications and Financial Information is used to achieve
Public comments are particularly invited on: Whether this collection of information is necessary for the functions of the General Services Administration Regulation, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding novation and change-of-name agreements.
Submit comments on or before August 5, 2024.
Written comments and recommendations for this information collection should be sent within 30 days of publication of this notice to
Zenaida Delgado, Procurement Analyst, at telephone 202-969-7207, or
9000-0076, Novation and Change-of-Name Agreements.
This clearance covers the information that contractors must submit to comply with the following requirements in Federal Acquisition Regulation (FAR) subpart 42.12:
• FAR
• FAR
• FAR
A. A 60-day notice was published in the
• For novation agreements:
✓ Define time frames in which the government will review the novation request and request any further information.
✓ Explicitly permitting the electronic submission of novation packages.
✓ Reserve the novation process for only actual transfer of assets which are embodied in a sale between two entirely separate unaffiliated legal entities.
✓ Include recognition of a successor in interest to Government contracts among entities registered in the System for Award Management (SAM) that have a common parent company when there is no transfer of assets.
✓ Allow for a streamlined process for a transfer of assets between two affiliated entities within the same corporate parent structure.
✓ Remove the requirement to provide the “approximate remaining unpaid balance” of contracts to be novated at FAR 42.1204(e)(2)(iv).
✓ Clarify that a novation process can begin before all the documents are submitted although it won't be complete until all necessary requirements are fully satisfied.
✓ Remove the requirement for a corporate seal or require it only if the novated contracts are above a very high dollar threshold.
✓ Replace the listed documents at FAR 42.1204(f)(1) to (3) with a simple Secretary's Certificate, certifying that all the activities (registration, approval by the board, etc.) have been completed.
✓ Require the government to appropriately deem an acquirer as a successor in interest to the proposals. This could be a confirmation or certification in SAM that the resources proposed remain available to perform and that the acquisition or novation does not change the ability to perform.
✓ Require that the contracting officer managing the contract with the largest total contract value be the responsible contracting officer to execute the novation agreement including a review by the government's legal counsel.
✓ Limit the list requested at FAR 42.1204(e)(2) to multiple year contracts identified at the time of submission of the request.
✓ Review the list of documentation being requested in light of the advancement of electronic records.
• For change-of-name agreements:
✓ Run the change-of-name process through SAM exclusively. Deem the name change automatically effective on all existing contracts and work orders and all pending submitted proposals via SAM.
✓ Limit the list requested at FAR 42.1205(a)(3) to multiple year contracts identified at the time of submission of the request.
✓ Explicitly permitting the electronic submission of change-of-name packages.
1. After completing the steps required by FAR 42.1205, the contractor would have to update/renew its entire Entity Registration in SAM and should be able to upload either the signed Change-of-Name Agreement or the signed SF30, Modification of Contract, satisfying what's required by the DLA CAGE team for screening and validation. See SAM's Knowledge Base articles #KB 0016829 and KB 0016831.
2. Before completing the steps required by FAR 42.1205, the contractor—
a. Must provide the notification required by paragraph (d) of the FAR clause at 52.204-13, System for Award Management Maintenance.
b. Would have to update/renew its entire Entity Registration in SAM.
c. When SAM sends the CAGE for screening and validation to the CAGE team, the team may request legal documentation to support the name change. This could result in the contractor getting a request from the DLA CAGE team for the same documentation needed to complete the steps required by FAR 42.1205. See SAM's Knowledge Base article #KB 0016831.
3. But the contractor does not have any open federal government contracts, then, the contractor would have to update/renew its entire Entity Registration in SAM. The contractor must provide the legal documentation needed to support the name change to the CAGE team to complete the CAGE/SAM validation process.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
On April 25, 2024, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published in the
The Challenge will accept applications through July 12, 2024.
Stormie Israel, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy. NE, Mailstop S107-5, Atlanta, GA 30341, Telephone: 770-488-2964, Email:
On April 25, 2024, CDC published a
This biennial challenge was established in 2019 to recognize extraordinary individuals, organizations, or community coalitions associated with the REACH program whose work has contributed to the implementation of culturally tailored interventions that advance health equity, reduce health disparities, and increase community engagement to address preventable risk behaviors (
To participate and submit an application, interested parties should go to
CDC reserves the right to cancel, suspend, and/or modify the Challenge, or any part of it, for any reason, at CDC's sole discretion.
Participation in this Challenge constitutes an applicants' full and unconditional agreement to abide by the Challenge's Official Rules found at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAXXIFY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the
FDA has approved for marketing the human biologic product DAXXIFY (daxibotulinumtoxinA-lanm). DAXXIFY is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Subsequent to this approval, the USPTO received patent term restoration applications for DAXXIFY (U.S. Patent Nos. 9,340,587; 9,956,435; and 10,111,939) from Revance Therapeutics, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of DAXXIFY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for DAXXIFY is 2,339 days. Of this time, 1,321 days occurred during the testing phase of the regulatory review period, while 1,018 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,214 days, 1,305 days, or 1,587 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RYSTIGGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product RYSTIGGO (rozanolixizumab-noli). RYSTIGGO is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Subsequent to this approval, the USPTO received a patent term restoration application for RYSTIGGO (U.S. Patent No. 10,233,243) from UCB Biopharma SRL, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated April 3, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of RYSTIGGO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for RYSTIGGO is 2,283 days. Of this time, 2,036 days occurred during the testing phase of the regulatory review period, while 247 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 902 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VABYSMO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 3, 2024. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product VABYSMO (faricimab-svoa). VABYSMO is indicated for treatment of patients with neovascular (Wet) age-related macular degeneration and diabetic macular edema. Subsequent to this approval, the USPTO received patent term restoration applications for VABYSMO (U.S. Patent Nos. 8,268,314 and 9,695,233) from Genentech, Inc.(Agent of Hoffmann-La Roche Inc.), and the USPTO requested FDA's assistance in determining this patents' eligibility for patent term restoration. In a letter dated September 28, 2023, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of VABYSMO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for VABYSMO is 3,046 days. Of this time, 2,800 days occurred during the testing phase of the regulatory review period, while 246 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 931 and 1,646 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of Mpox. FDA has issued the Authorization for Labcorp Monkeypox PCR (Polymerase Chain Reaction) Test Home Collection Kit as requested by Laboratory Corporation of America. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for
The Authorization is effective as of March 22, 2024.
Submit written requests for single copies of an EUA to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a toll-free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives (among other criteria).
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents or (B) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces;
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.
The Authorization follows the August 9, 2022, determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. Notice of the Secretary's determination was provided in the
An electronic version of this document and the full text of the Authorization is available at:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENJAYMO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product ENJAYMO (sutimlimab-jome). ENJAYMO is indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease. Subsequent to this approval, the USPTO received patent term restoration applications for ENJAYMO (U.S. Patent Nos. 8,877,197 and 10,450,382) from Bioverativ USA Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2023, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ENJAYMO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ENJAYMO is 1,845 days. Of this time, 1,151 days occurred during the testing phase of the regulatory review period, while 694 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines general principles on planning, designing, and analyzing observational (noninterventional) pharmacoepidemiological studies that utilize fit-for-purpose data for safety assessment of medicines (drugs, vaccines, and other biological products). The draft guidance includes recommendations and high-level best practices for the conduct of these studies. The draft guidance is intended to streamline the development and regulatory assessment of postmarketing pharmacoepidemiological safety studies that include Real-World Data. This guidance also seeks to improve the ability of the study protocol and/or results to be accepted across health authorities and support decision making in response to study results.
Submit either electronic or written comments on the draft guidance by September 3, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
FDA is announcing the availability of a draft guidance for industry entitled “M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines.” The draft guidance was prepared under the auspices of ICH. ICH seeks to achieve greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.
By harmonizing the regulatory requirements in regions around the world, ICH guidelines enhance global drug development, improve manufacturing standards, and increase the availability of medications. For example, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, and standardized marketing application submissions.
The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. ICH membership continues to expand to include other regulatory authorities and industry associations from around the world (refer to
ICH works by engaging global regulatory and industry experts in a detailed, science-based, and consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
In May 2024, the ICH Assembly endorsed the draft guideline entitled “M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines” and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Quality Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Quality Expert Working Group.
This draft guidance provides general considerations and recommendations for use of real-world data for drug, vaccine, and other biologic product safety assessments. The draft guidance seeks to harmonize regional recommendations for the design, analysis, and reporting of postmarketing pharmacoepidemiologic studies that use real-world data as the number of pharmacoepidemiological studies utilizing real-world data in a regulatory context have increased globally.
This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDA's good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on “M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiologic Studies That Utilize Real-World Data for Safety Assessment of Medicines.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information supporting investigational new drug regulations in 21 CFR part 312 have been approved under OMB control number 0910-0014. The collections of information supporting FDA approval of new drugs in part 314 (21 CFR part 314) have been approved under OMB control number 0910-0001. The collections of information supporting general licensing provisions of biological products in 21 CFR part 601 have been approved under OMB control number 0910-0338. The collections of information supporting adverse experience reporting in 21 CFR 310.305 and 329.100, and §§ 314.80, 314.81, and 314.98, have been approved under OMB control number 0910-0230. The collections of information supporting MedWatch safety and adverse event reporting have been approved under OMB control number 0910-0291. The collections of information supporting biological products postmarket adverse experience reporting in 21 CFR part 600 have been approved under OMB control number 0910-0308 and the collections of information supporting medical device reporting have been approved under OMB control number 0910-0437.
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of Mpox. FDA has issued an Authorization for an in vitro diagnostic device, Non-variola
The Authorization is effective as of March 22, 2024.
Submit written requests for single copies of an EUA to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a toll-free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives (among other criteria).
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents or (B) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces;
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.
The Authorization follows the August 9, 2022, determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. Notice of the Secretary's determination was provided in the
An electronic version of this document and the full text of the Authorization is available on the internet from:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMJUDO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product IMJUDO (tremelimumab-actl). IMJUDO is indicated (1) in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma and (2) in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations. Subsequent to this approval, the USPTO received patent term restoration applications for IMJUDO (U.S. Patent Nos. 9,487,581; 10,232,040; and 11,446,377) from AstraZeneca AB, and the USPTO requested FDA's assistance in determining this patents' eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IMJUDO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for IMJUDO is 7,634 days. Of this time, 7,393 days occurred during the testing phase of the regulatory review period, while 241 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 32, 529, or 1,208 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUNSUMIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase
FDA has approved for marketing the human biologic product LUNSUMIO (mosunetuzumab-axgb). LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Subsequent to this approval, the USPTO received a patent term restoration application for LUNSUMIO (U.S. Patent Nos. 10,174,124 and 11,186,650) from Genentech, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of LUNSUMIO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for LUNSUMIO is 2,809 days. Of this time, 2,571 days occurred during the testing phase of the regulatory review period, while 238 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 313 or 842 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In accordance with the Federal Advisory Committee Act this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on the ACHDNC website at
Thursday, August 8, 2024, from 10:00 a.m. to 4:00 p.m. Eastern Time (ET) and Friday, August 9, 2024, from 10:00 a.m. to 2:00 p.m. ET.
This meeting will be held in person with webcast options. While this meeting is open to the public, advance registration is required. Please visit the ACHDNC website for information on registration:
If you are a non-U.S. citizen who would like to attend the August meeting in-person, please contact
Kim Morrison, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room, Rockville, Maryland 20857; 301-443-6672; or
ACHDNC provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. The ACHDNC reviews and reports regularly on newborn and childhood screening practices, recommends improvements in the national newborn and childhood screening programs, and fulfills
During the August 8-9, 2024, meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Possible agenda items may include the following topics:
(1) A presentation on types of screening that are a part of the standard of care in a clinical setting;
(2) An update on the ACHDNC nomination process;
(3) A presentation on the revisions to the decision matrix and a potential vote on whether to adopt the proposed revisions to the ACHDNC decision matrix and process; and
(4) An update on the Metachromatic Leukodystrophy condition nomination and a potential vote on whether to move it forward to full evidence-based review, which, depending on the strength of the evidence, could lead to a future recommendation to add this condition to the Recommended Uniform Screening Panel.
Agenda items are subject to change as priorities dictate. Information about ACHDNC, including a roster of members and past meeting summaries, is also available on the ACHDNC website.
Members of the public will have the opportunity to provide comments on any of the above agenda items. Public participants may request to provide general oral comments and may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to provide a written statement or make oral comments to ACHDNC must be submitted via the registration website by 12:00 p.m. ET on Thursday, July 25, 2024. Written comments will be shared with the Committee prior to the meeting so that they have an opportunity to consider them in advance of the meeting.
Individuals who need special assistance or another reasonable accommodation should notify Kim Morrison at the address and phone number listed above at least 10 business days prior to the meeting.
Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 15 business days prior to the meeting to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning the opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276-0361.
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention (CSAP) and Center for Substance Abuse Treatment (CSAT) are requesting approval from the Office of Management and Budget (OMB) to monitor the Minority AIDS Initiative: Substance Use Disorder Prevention and Treatment Pilot Program (MAI PT Pilot) through administration of a suite of data collection instruments for grant compliance and programmatic performance monitoring. This package describes the data collection activities and proposed instruments. Two instruments will facilitate grant compliance monitoring, and the third instrument is designed for program performance monitoring.
• The
• The
• The
Data collected through the MAI-PORT are necessary to ensure SAMHSA and grantees comply with requirements under the Government Performance and Results Act Modernization Act of 2010
According to the Centers for Disease Control and Prevention (CDC), the spread of HIV in the United States is mainly through anal or vaginal sex or by sharing drug-use equipment. Although these risk factors are the same for everyone, due to a range of social, economic, and demographic factors, such as stigma, discrimination, income, education, and geographic region, some racial and ethnic groups are more affected than others. In 2021, CDC reported that although Black/African Americans represented 13 percent of the U.S. population, they accounted for 42 percent (15,305) of the 36,801 new HIV diagnoses; Latino/Hispanic people represent 18.7 percent of the U.S. population but accounted for 29 percent (10,494) of HIV diagnoses (CDC, 2024; United States Census Bureau, 2024). Between 2017 and 2021, American Indian/Alaska Native (AI/AN), Native Hawaiian and other Pacific Islander populations were the only demographic groups identified by the CDC with an increase in HIV diagnoses in the United States (CDC, 2024).
Viral hepatitis also impacts some racial and ethnic groups disproportionally. In 2020, non-Hispanic blacks were 1.4 times as likely to die from viral hepatitis, as compared to non-Hispanic whites (Office of Minority Health, 2022). Non-Hispanic blacks were almost twice as likely to die from hepatitis C as compared to the white population, and while having comparable case rates for hepatitis B in 2020, non-Hispanic blacks were 2.5 times more likely to die from hepatitis B than non-Hispanic whites (Office of Minority Health, 2022). Additionally, the percentage of people aged 12 or older with past year substance use disorder (SUD) differed by race and ethnicity with the highest rates among American Indian/Alaska Native populations (24.0 percent), followed by Black, non-Hispanic populations (18.4 percent) (SAMHSA, 2023).
The data clearly show the disproportionate burden faced by minority racial and ethnic groups and that these three issues should not be regarded as separate diseases acting independently, rather as a syndemic. To address this, SAMHSA is taking a syndemic approach to HIV, viral hepatitis, and substance use disorder through the MAI PT Pilot program. The purpose of this program is to provide substance use prevention, SUD treatment, HIV, and viral hepatitis prevention and treatment services for racial and ethnic medically underserved individuals vulnerable to a SUD and/or mental health condition, HIV, viral hepatitis, and other infectious disease (
SAMHSA's MAI PT Pilot is informed by the key strategies and priority jurisdictions outlined in the Ending the HIV Epidemic in the U.S. (EHE) initiative, Viral Hepatitis National Strategic Plan and STI National Strategic Plan. The program also supports the National HIV/AIDS Strategy (NHAS) and 2023-2026 SAMHSA Strategic Plan. Recipients will be expected to take a syndemic approach to SUD, HIV, viral hepatitis, and STI by providing SUD prevention and treatment to racial and ethnic individuals at risk for or living with HIV. MAI PT Pilot is authorized under Sections 509 and 516 of the Public Health Service Act, as amended.
Table 1 and Table 2 provides an overview of the data collection method, frequency of data collection, and number of data collections for each data collection instruments.
The estimated time to complete each instrument by year is shown in Tables 3 through 8.
Send comments to SAMHSA Reports Clearance Officer, 5600 Fisher Lane, Room 15E45, Rockville, MD 20852 OR email him a copy at
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer at (240) 276-0361 or
Comments are invited on: (a) whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
1. The award of community-based coalition enhancement grants for underage drinking prevention activities to eligible entities currently receiving funds under the Drug-Free Communities Act of 1997.
2. A national adult-oriented media public service campaign to prevent underage drinking (“Talk. They Hear You.” (TTHY), and an annual report to Congress evaluating the campaign.
3. An annual report to Congress summarizing federal prevention activities and the extent of progress in reducing underage drinking nationally, including data from national surveys conducted by federal agencies.
4. An annual report to Congress “on each State's performance in enacting, enforcing, and creating laws, regulations, and programs to prevent or reduce underage drinking.” The State Survey that is the subject of this request gathers data used to develop the state-by-state report on prevention and enforcement activities related to underage drinking
Driven by the legislation and coordinated by the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD), each of these activities work together to prevent and reduce underage drinking. The Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD) provides national leadership in federal policy and programming to support state and community activities that prevent and reduce underage drinking. The data collection activities described in this package serve to assess the outputs and outcomes of public health messaging and interventions. The three data collection activities outlined in this package are:
1. The STOP Act State Survey: An annual survey mandated by the STOP Act legislation sent to an individual designated by the governor of all 50 states and the mayor of the District of Columbia;
2. The ICCPUD Alcohol Policy Academy Evaluation: An assessment of coalition capacity and workforce development throughout a 12 month Alcohol Policy Academy; and
3. The Parents Night Out Evaluation; An assessment of changes in knowledge, skills, and confidence of parents and caregivers after receiving the training and materials for Parents Night Out and TTHY products.
The STOP Act states that the “Secretary [of Health and Human Services] shall . . . annually issue a report on each state's performance in enacting, enforcing, and creating laws, regulations, and programs to prevent or reduce underage drinking.” The Secretary has delegated responsibility for this report to SAMHSA. Therefore, SAMHSA has developed a “Survey of State Underage Drinking Prevention Policies, Programs, and Practices” (the “State Survey”) to provide input for the state-by-state report on prevention and enforcement activities related to the underage drinking component of the “Annual Report to Congress on the Prevention and Reduction of Underage Drinking” (“Report to Congress”).
Congress' purpose in mandating the collection of data on state policies, programs, and practices through the
SAMHSA has determined that data on Categories #2 and #3 mandated in the STOP Act (as listed on page 2) (enforcement and educational programs; programs targeting youth, parents, and caregivers) as well as states' collaborations with tribal governments, use of social marketing or counter-advertising campaigns, state-level interagency collaborations, and prevention workforce development activities
The
SAMHSA collects the required data using an online survey data collection platform. Links to the survey are distributed to states via email. The
The estimated annual response burden to collect this information is as follows:
The
The evaluation is comprised of seven surveys and one focus group. Surveys are conducted after each monthly training and coaching call. The participant surveys seek feedback on changes in knowledge, skills, and confidence after each training or coaches call, as well as feedback on the training content and training/coaching provider. The coach surveys track the progress of the coalitions. These surveys take the participants and coaches approximately 5-10 minutes each. The participants will also complete a baseline survey, a 12-month survey, and an 18-month survey. These surveys assess whether participants reach their own goals during the Policy Academy, how they share their knowledge and skills gained, and how they continue to progress in the policy process. All surveys will be fielded using a web-based survey tool. The focus group with the cohort will collect qualitative data from the participants on their experience and efforts to incorporate health equity into their policy campaign.
Table 2 indicates the estimated total annual burden on the participants and coaches of the
The estimated annual response burden to collect this information is as follows:
The “Talk. They Hear You” campaign is comprised of a variety of tools and resources designed to decrease underage drinking by encouraging parents and caregivers, educators, and community members/organizations to proactively engage youth in conversations about alcohol another other drugs. Research has demonstrated that active and engaged adults can reduce underage drinking.
The
PNO data will be collected from participants through a survey delivered via email using Qualtrics. Completing the survey is not a requirement of the event, but an option to provide feedback to the campaign team. Collecting data through Qualtrics will improve the participant experience and allow them to quickly provide feedback. The distribution of the
Table 4 indicates the estimated total annual burden on the participants of PNO. The survey estimates include reading the instructions and questions and responding to each question, and totals 7 minutes. The wage rate was determined based on the highest state minimum wage, as site locations have not yet been identified.
The estimated annual response burden to collect this information is as follows:
Send comments to Alicia Broadus, SAMHSA Public Health Advisor at
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities.
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Department of Homeland Security, U.S. Immigration and Customs Enforcement.
Notice of a modified system of records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to modify and reissue a current DHS system of records titled, “DHS/U.S. Immigration and Customs Enforcement (ICE)-011 Criminal Arrest Records and Immigration Enforcement Records
Submit comments on or before August 5, 2024. This modified system will be effective August 5, 2024.
You may submit comments, identified by docket number ICEB-2023-0011 by one of the following methods:
•
•
•
For general questions, please contact: Ieshah Geary, Privacy Officer, Office of Information Governance and Privacy,
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS/ICE proposes to modify and reissue a current DHS system of records titled, “DHS/ICE-011 Criminal Arrest Records and Immigration Enforcement Records (CARIER) System of Records.” DHS/ICE maintains the CARIER system of records to support the identification, apprehension, and removal of individuals unlawfully entering or present in the United States; and to support the identification and arrest of individuals who commit violations of federal laws enforced by DHS.
DHS/ICE is modifying and reissuing this system of records notice to update the purpose of the system to include the following purposes: (1) to monitor individuals unlawfully entering or present in the United States in violation of the Immigration and Nationality Act, including non-detained non-citizens; (2) to support geolocation tracking, biometric verification, and rapid enrollment of non-citizens into the ICE Enforcement and Removal Operations (ERO) Alternatives to Detention (ATD) program; and (3) to improve coordination necessary to efficiently transfer/transport individuals from the U.S. Customs and Border Protection (CBP) to ICE and subsequently from ICE to various family residential centers and detention facilities. DHS/ICE is also updating the categories of individuals covered by this system of records to include those individuals on the “non-detained” docket and Alternatives to Detention program. Additionally, DHS/ICE is updating the categories of records to include geolocation records derived from technologies such as the Global Positioning System (GPS) and records pertaining to family unit identification number (FAMU ID).
ICE is also removing several routine uses from the previous system of records notice. After careful review and consideration, ICE is removing previous redundancies to ensure the System of Records Notice is focused solely on the system's purpose, categories of individuals, records, and routine uses for the identification, apprehension, and removal of non-citizens unlawfully present in the United States. The previous routine uses have been removed: Routine Use O, Routine Use S, Routine Use V, Routine Use Z, Routine Use AA, Routine Use BB, Routine Use JJ, and Routine Use YY.
Finally, DHS/ICE is proposing to modify and add the following routine uses:
• Modify routine use (E) and add routine use (F) to allow DHS/ICE to share records with appropriate federal agencies or entities when reasonably necessary to respond to a breach of personally identifiable information and to prevent, minimize, or remedy the risk of harm to individuals or the Federal Government, or assist an agency in locating individuals affected by a breach in accordance with Office of Management and Budget (OMB) Memorandum M-17-12 “Preparing for and Responding to a Breach of Personally Identifiable Information,” (Jan. 3, 2017).
• Add routine use (XX) to allow ICE to share records through the Law Enforcement Information Sharing Service (LEISS) with federal, state, local, tribal, regional, foreign, or international law enforcement agencies that are party to a LEISS Memorandum of Agreement. LEISS is a non-public facing web service that functions as a bi-directional data sharing system between DHS and member agencies for the purpose of criminal law enforcement, homeland/national security, or applicant background investigations.
• Add routine use (YY) to allow ICE to share information with an appropriate federal, state, local, tribal, territorial, foreign, or international agency and third-party organizations assisting in the repatriation of non-citizens who are returning voluntarily to their home countries.
The Routine Use Section is also being renumbered to account for the added and removed routine uses listed above. Non-substantive language changes have been made to the added routine uses to clarify disclosure policies that are standard across DHS and to align with previously published DHS system of records notices.
Consistent with DHS's information sharing mission, information stored in the DHS/ICE-011 CARIER System of Records may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/ICE may share information with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice. This modified system will be included in DHS's inventory of records systems.
The fair information practice principles found in the Privacy Act underpin the statutory framework governing the means by which Federal Government agencies collect, maintain,
Below is the description of the DHS/ICE-011 CARIER System of Records.
In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/U.S. Immigration and Customs Enforcement (ICE)-011 Criminal Arrest Records and Immigration Enforcement Records (CARIER).
Unclassified. The data may be retained on classified networks, but this does not change the nature and character of the data until it is combined with classified information.
Records are maintained in DHS/ICE information technology (IT) systems (
Executive Associate Director, Office of Enforcement and Removal Operations, U.S. Immigration & Customs Enforcement, 500 12th Street SW, Washington, DC 20536.
Authority for maintaining this system is in sections 103, 235, 236, 274, 287, and 290 of the Immigration and Nationality Act (INA), 8 United States Code, sections 1103, 1225, 1226, 1324, 1357, 1360, and 1365(a)(b); Title 18, United States Code, Chapters 27, 77, 85, 95, 109A, 110, 113, and 117; Title 31, United States Code, Chapter 53, Subchapter II; Title 50 Appendix, United States Code; The Tariff Act of 1930; Justice for All Act of 2004 (Pub. L. 108-405); DNA Fingerprint Act of 2005 (Pub. L. 109-162); Adam Walsh Child Protection and Safety Act of 2006 (Pub. L. 109-248); and 28 CFR part 28, “DNA-Sample Collection and Biological Evidence Preservation in the Federal Jurisdiction.”
The purposes of this system are:
1. To support the identification, arrest, charging, monitoring, detention, and/or removal of individuals unlawfully entering or present in the United States in violation of the INA, including fugitive non-citizens, non-detained non-citizens, and non-lawful re-entrants.
2. To support the identification and arrest of individuals (both citizens and non-citizens) who commit violations of criminal laws enforced by DHS/ICE.
3. To track the process and results of administrative and criminal proceedings, including compliance with court orders and hearing dates, against individuals who are alleged to have violated the INA or other laws enforced by DHS.
4. To support the grant or denial of parole and tracking of individuals who seek or receive parole into the United States.
5. To provide criminal and immigration history information during DHS enforcement encounters, and to support background checks on applicants for DHS immigration benefits (
6. To identify potential criminal activity, immigration violations, and threats to homeland security, to ensure public safety, and to uphold laws enforced by DHS.
7. To support the geolocation tracking, biometric verification, and rapid enrollment of non-citizens into the ICE Alternatives to Detention program.
8. To improve the coordination necessary to efficiently transfer/transport individuals from CBP to ICE and from ICE to various detention facilities.
Categories of individuals covered by this system include: (1) individuals arrested, detained, or removed from the United States for criminal or administrative violations of the INA, or individuals issued a Notice to Appear in immigration court; (2) individuals who are the subject of an immigration detainer issued to another law enforcement or custodial agency; (3) individuals arrested by ICE for violations of criminal laws enforced by ICE or DHS; (4) individuals who fail to leave the United States after receiving a final order of removal, deportation, or exclusion, or who fail to report to ICE for removal after receiving notice to do so (fugitive non-citizens); (5) individuals who non-lawfully re-enter the United States after departing pursuant to an order of voluntary departure or being removed from the United States (non-lawful re-entrants); (6) individuals who request to be removed at their own expense or are eligible for voluntary removal from the United States pursuant to section 250 of the INA; (7) individuals who are granted parole into the United States under section 212(d)(5) of the INA (parolees); (8) individuals awaiting immigration proceedings under a “non-detained” or Alternatives to Detention program; (9) other individuals whose information may be collected or obtained during the course of an immigration enforcement or criminal matter, such as witnesses, associates, and relatives; (10) persons who post or arrange bond for the release of an individual from ICE detention, or receive custodial property of a detained non-citizen; (11) prisoners of the U.S. Marshals Service held in ICE detention facilities; and (12) attorneys or representatives who represent individuals listed in the categories above.
Biographic, biometric, descriptive, historical, and other identifying data, including:
• Full name;
• Alias(es);
• A-Number;
• Social Security number (SSN);
• Date of birth;
• Place of birth;
• Nationality;
• Fingerprint Identification Number (FIN);
• Federal Bureau of Investigation (FBI) number;
• Other unique identifying numbers (
• Government-issued identification (
○ Document type;
○ Issuing organization;
○ Document number;
○ Expiration date;
• Visa information;
• Contact or location information (
• Employment history;
• Education history;
• Immigration history (
• Domestic and foreign criminal history (
• Physical description (
• Biometric data (
○ DNA samples required by DOJ regulation (see 28 CFR part 28) are collected and sent to the FBI. DNA samples are not retained or analyzed by DHS, nor does ICE receive or maintain the results of the FBI's DNA analysis (
○ Information pertaining to ICE's collection of DNA samples, limited to the date and time of successful collection and confirmation from the FBI that the sample was able to be sequenced, is maintained by ICE and DHS.
Case-related data:
• Case number;
• Family unit identification number ID numbers;
• Record number;
• Case category;
• Description of charges and disposition of arrest;
• Case agent;
• Data initiated and completed;
• Location-related data, including geotags from metadata associated with other record categories collected; geographical indicators; and geolocation information (
• National Sex Offender Registry (NSOR) status; and
• Other data describing an event involving alleged violations of criminal or immigration law (
Information presented to or collected by ICE during immigration and law enforcement proceedings or activities:
• Date of birth;
• Place of birth;
• Marital status;
• Education history;
• Employment history;
• Travel history; and
• Other information derived from affidavits, certificates, manifests, and other documents. This data typically pertains to subjects, relatives, associates, and witnesses.
Detention data on non-citizens:
• Immigration detainers issued;
• Transportation information;
• Detention-related identification numbers;
• Detention facility;
• Security, risk, and custody classification;
• Custody recommendation and status;
• Flight risk indication;
• Book-in/book-out date and time;
• Mandatory detention and criminal flags;
• Aggravated felon status;
• Other alerts (
• Information about a non-citizen's release from custody on bond, recognizance, or supervision;
• Information related to prosecutorial discretion determinations;
• Property inventory and receipt;
• Information related to disciplinary issues or grievances;
• Documents and video recordings related to alleged misconduct and other incidents involving detainees; and
• Other detention-related information (
Detention data for U.S. Marshals Service prisoners:
• Full name;
• Date of birth;
• Country of birth;
• Identification numbers (
• Book-in/book-out date and time; and
• Security classification.
Limited health information relevant to an individual's placement in an ICE detention facility or transportation requirements:
• Medical alerts, mental competency, or general information on physical disabilities or other special needs or vulnerabilities to facilitate placement in a facility or bed that best accommodates these needs. Medical records about individuals in ICE custody (
Progress, status, and final result of removal, prosecution, and other DHS processes and related appeals:
• Information relating to criminal convictions;
• Incarceration;
• Travel documents; and
• Other information pertaining to the actual removal of non-citizens from the United States.
Contact, biographical, and identifying data about Relatives, Attorneys, Representatives, Associates, or Witnesses of a noncitizen in proceedings initiated or conducted by DHS may include:
• Full name;
• Date of birth;
• Place of birth; and
• Contact or location information (
Data concerning personnel of other agencies that arrested, or assisted or participated in the arrest or investigation of, or are maintaining custody of an individual whose arrest record is contained in this system of records may include:
• Full name;
• Title; and
• Contact or location information (
Data about persons who post or arrange an immigration bond for the release of an individual from ICE custody, or receive custodial property of an individual in ICE custody may include:
• Full name;
• Address;
• Phone numbers; and
• Social Security number.
Recordings of detainee telephone calls when responding as part of an alternative to detention program or of detainee calls made in detention facilities. Information about these calls may include:
• Date;
• Time;
• Duration; and
• Phone number called. (Note: protected telephone calls, such as calls with an attorney, are not recorded and information about protected telephone calls is not retained.)
Information related to detainees' accounts for telephone or commissary services in a detention facility.
Records are obtained from several sources. In general, information is obtained from individuals covered by this system, and other federal, state, local, tribal, or foreign governments. More specifically, DHS/ICE-011 records derive from the following sources:
(a) Individuals covered by the system and other individuals (
(b) Other federal, state, local, tribal, or foreign governments and government information systems;
(c) Business records;
(d) Evidence, contraband, and other seized material; and
(e) Public and commercial sources, including social media.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the Department of Justice (DOJ), including Offices of the United States Attorneys, or other federal agencies conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant and necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
1. DHS or any component thereof;
2. Any employee or former employee of DHS in their official capacity;
3. Any employee or former employee of DHS in their individual capacity when DOJ or DHS has agreed to represent the employee; or
4. The United States or any agency thereof.
B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.
C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. secs. 2904 and 2906.
D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
E. To appropriate agencies, entities, and persons when (1) DHS suspects or has confirmed that there has been a breach of the system of records; (2) DHS has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, DHS (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
F. To another federal agency or federal entity when DHS determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the federal government, or national security resulting from a suspected or confirmed breach.
G. To an appropriate federal, state, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
H. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.
I. To prospective claimants and their attorneys for the purpose of negotiating the settlement of an actual or prospective claim against DHS or its current or former employees, in advance of the initiation of formal litigation or proceedings.
J. To appropriate federal, state, local, tribal, territorial, or foreign government agencies, as well as to other individuals and organizations during the course of an investigation by DHS or the processing of a matter under DHS's jurisdiction, or during a proceeding within the purview of immigration and nationality laws, when DHS deems that such disclosure is necessary to carry out its functions and statutory mandates or to elicit information required by DHS to carry out its functions and statutory mandates.
K. To federal, state, local, tribal, or territorial government agencies, or other entities or individuals, or through established liaison channels to selected foreign governments, to provide intelligence, counterintelligence, or other information for the purposes of national security, intelligence, counterintelligence, or antiterrorism activities authorized by U.S. law, Executive Order, or other applicable national security directive.
L. To federal and foreign government intelligence or counterterrorism agencies or components when DHS becomes aware of an indication of a threat or potential threat to national or international security, or when such disclosure is to support the conduct of national intelligence and security investigations or to assist in anti-terrorism efforts.
M. To any federal agency to enable such agency to make determinations regarding the payment of federal benefits to the record subject in accordance with that agency's statutory responsibilities.
N. To foreign governments for the purpose of coordinating and conducting the removal of non-citizens from the United States to other nations under the Immigration and Nationality Act; and to international, foreign, intergovernmental, and multinational agencies, authorities, and organizations in accordance with law and formal or informal international arrangements.
O. To the DOJ Executive Office of Immigration Review (EOIR) or its contractors, consultants, or others performing or working on a contract for EOIR, for the purpose of providing information about non-citizens who are or may be placed in removal proceedings so that EOIR may arrange for the provision of educational services to those non-citizens under EOIR's Legal Orientation Program, or for other purposes or activities within the scope of the EOIR contract.
P. To disclose information to the DOJ EOIR and to the Board of Immigration Appeals, to the extent necessary to carry out their authorized duties pertaining to the adjudication of matters arising under the Immigration and Nationality Act.
Q. To attorneys or legal representatives for the purpose of facilitating group presentations to non-
R. To the Department of State in the processing of petitions or applications for benefits under the Immigration and Nationality Act, and all other immigration and nationality laws including treaties and reciprocal agreements; or when the Department of State requires information to consider or provide an informed response to a request for information from a foreign, international, or intergovernmental agency, authority, or organization about a non-citizen or an enforcement operation with transnational implications.
S. To OMB in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in the Circular.
T. To federal, state, local, territorial, tribal, international, or foreign criminal, civil, or regulatory law enforcement authorities when the information is necessary for collaboration, coordination, and de-confliction of investigative matters, prosecutions, and/or other law enforcement actions to avoid duplicative or disruptive efforts and to ensure the safety of law enforcement officers who may be working on related law enforcement matters.
U. To the U.S. Marshals Service (USMS) concerning USMS prisoners that are or will be held in detention facilities operated by or on behalf of ICE, and to federal, state, local, tribal, or territorial law enforcement or correctional agencies concerning individuals in DHS custody that are to be transferred to such agency's custody, to coordinate the transportation, custody, and care of these individuals.
V. To third parties to facilitate placement or release of an individual (
W. To victims and witnesses regarding custodial information, such as transfer to another custodial agency or location, release on bond, order of supervision, removal from the United States, or death in custody, about an individual who is the subject of a criminal or immigration investigation, proceeding, or prosecution. This would also authorize disclosure of custodial information to individuals with a legal responsibility to act on behalf of a victim or witness (
X. To the Federal Bureau of Prisons (BOP) and other federal, state, local, territorial, tribal, and foreign law enforcement or custodial agencies for the purpose of facilitating the transfer of custody of an individual to or from that agency. This will include the transfer of information about unaccompanied minor children to the U.S. Department of Health and Human Services (HHS) to facilitate the custodial transfer of such children from DHS to HHS.
Y. To DOJ and other law enforcement or custodial agencies to facilitate payments and reporting under the State Criminal Alien Assistance Program or similar programs.
Z. To any law enforcement agency or custodial agency (such as a jail or prison) to serve that agency with notice of an immigration detainer, or to update or remove a previously issued immigration detainer, for an individual who is believed to be in that agency's custody.
AA. To DOJ, disclosure of DNA samples and related information as required by 28 CFR part 28.
BB. To DOJ, disclosure of arrest and removal information for inclusion in relevant DOJ law enforcement databases and for use in the enforcement of federal firearms laws (
CC. To the attorney or guardian ad litem of an individual's child, or to federal, state, local, tribal, territorial, or foreign governmental or quasi-governmental agencies or courts, to confirm the location, custodial status, removal, or voluntary departure of an individual from the United States, to facilitate the recipients' exercise of responsibilities pertaining to the custody, care, or legal rights (including issuance of a U.S. passport) of the individual's children, or the adjudication or collection of child support payments or other similar debts owed by the individual.
DD. To an individual or entity seeking to post or arrange, or who has already posted or arranged, an immigration bond for a noncitizen to aid the individual or entity in (1) identifying the location of the noncitizen; (2) posting the bond; (3) obtaining payments related to the bond; or (4) conducting other administrative or financial management activities related to the bond.
EE. To federal, state, local, tribal, territorial, or foreign government agencies or entities or multinational governmental agencies when DHS needs to exchange relevant data for the purpose of developing, testing, or implementing new software or technology whose purpose is related to this system of records.
FF. Limited detainee biographical information will be publicly disclosed via the ICE Online Detainee Locator System or any successor system for the purpose of identifying whether a detainee is in ICE custody and the custodial location.
GG. To courts, magistrates, administrative tribunals, opposing counsel, parties, and witnesses, in immigration, civil, or criminal proceedings (including discovery, presentation of evidence, and settlement negotiations) and when DHS determines that use of such records is relevant and necessary to the litigation before a court or adjudicative body when any of the following is a party to or have an interest in the litigation:
1. DHS or any component thereof;
2. Any employee of DHS in their official capacity;
3. Any employee of DHS in their individual capacity when DOJ or DHS has agreed to represent the employee; or
4. The United States, when DHS determines that litigation is likely to affect DHS or any of its components.
HH. To federal, state, local, tribal, territorial, international, or foreign government agencies or entities for the purpose of consulting with that agency or entity:
1. To assist in making a determination regarding redress for an individual in connection with the operations of a DHS component or program;
2. To verify the identity of an individual seeking redress in connection with the operations of a DHS component or program; or
3. To verify the accuracy of information submitted by an individual who has requested such redress on behalf of another individual.
II. To federal, state, local, tribal, territorial, or foreign governmental agencies; multilateral governmental organizations; or other public health entities, for the purposes of protecting the vital interests of a record subject or other persons, including to assist such agencies or organizations during an epidemiological investigation, in facilitating continuity of care, in preventing exposure to or transmission of a communicable or quarantinable disease of public health significance, or
JJ. To foreign governments for the purpose of providing information about their citizens or permanent residents, or family members thereof, during local or national disasters or health emergencies.
KK. To a coroner for purposes of affirmatively identifying a deceased individual (whether or not such individual is deceased as a result of a crime) or cause of death.
LL. To a former employee of DHS for purposes of responding to an official inquiry by Federal, State, local, tribal, or territorial government agencies or professional licensing authorities; or facilitating communications with a former employee that may be relevant and necessary for personnel-related or other official purposes, when DHS requires information or consultation assistance from the former employee regarding a matter within that person's former area of responsibility.
MM. To federal, state, local, tribal, territorial, foreign, or international agencies, if the information is relevant and necessary to a requesting agency's decision concerning the hiring or retention of an individual, or the issuance, grant, renewal, suspension or revocation of a security clearance, license, contract, grant, or other benefit; or if the information is relevant and necessary to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant, or other benefit.
NN. To a public or professional licensing organization when such information indicates, either by itself or in combination with other information, a violation or potential violation of professional standards, or reflects on the moral, educational, or professional qualifications of licensed professionals or those seeking to become licensed professionals.
OO. To an attorney or representative (as defined in 8 CFR 1.2, 202.1, 1001.1(f), or 1202.12) who is acting on behalf of an individual covered by this system of records in connection with any proceeding before U.S. Citizenship and Immigration Services (USCIS), ICE, CBP, or EOIR, as required by law or as deemed necessary in the discretion of the Department.
PP. To members of the public, with regard to disclosure of limited detainee biographical information for the purpose of facilitating the deposit of monies into detainees' accounts for telephone or commissary services in a detention facility.
QQ. To federal, state, local, tribal, or territorial government agencies seeking to verify or ascertain the citizenship or immigration status of any individual within the jurisdiction of the agency for any purpose authorized by law.
RR. To federal, state, local, tribal, and territorial courts or government agencies involved in criminal investigation or prosecution, pre-trial, sentencing, parole, probation, bail bonds, or any other aspect of the criminal justice process, and to defense counsel representing an individual in a domestic criminal proceeding, to ensure the integrity and efficiency of the criminal justice system by informing these recipients of the existence of an immigration detainer or the individual's status in removal proceedings, including removal or custodial status/location. Disclosure of the individual's A-Number and country of birth is also authorized to facilitate these recipients' use of the ICE Online Detainee Locator System for the purposes listed above.
SS. To a foreign government to notify it concerning its citizens or residents who are incapacitated, an unaccompanied minor, or deceased.
TT. To family members, guardians, committees, friends, or other agents identified by law or regulation to receive notification, decisions, and other papers as provided in 8 CFR 103.8 from DHS or EOIR following verification of a familial or agency relationship with a non-citizen when DHS is aware of indicia of incompetency or when a non-citizen has been determined to be mentally incompetent by an immigration judge.
UU. To an organization or person in either the public or private sector, either foreign or domestic, when there is a reason to believe that the recipient is or could become the target of a particular terrorist activity or conspiracy, or when the information is relevant to the protection of life, property, or other vital interests of a person.
VV. To clerks and judges of courts exercising naturalization jurisdiction for the purpose of granting or revoking naturalization.
WW. To federal, state, local, tribal, territorial, foreign, or international agencies, after discovery of such information, if DHS determines: (1) The information is relevant and necessary to that agency's decision concerning the hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit; and (2) Failure to disclose the information is likely to create a substantial risk to government facilities, equipment, or personnel; sensitive information; critical infrastructure; or public safety.
XX. To an appropriate federal, state, local, tribal, regional, foreign, or international law enforcement agency, where use is consistent with the official duties of the recipient agencyand the requirements set forth in a related memorandum of agreement between DHS and the recipient agency authorizing information sharing through LEISS for the purpose of criminal law enforcement, homeland security, or to support applicant background investigations for ICE law enforcement partners.
YY. To an appropriate federal, state, local, tribal, territorial, foreign, or international agency and third-party organizations assisting in the repatriation of non-citizens who are returning voluntarily to their home countries.
ZZ. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS's officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute a clearly unwarranted invasion of personal privacy.
DHS/ICE stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records may be stored on magnetic disc, tape, and digital media.
Records may be retrieved by name, biometric identifiers, identification numbers including, but not limited to, A-Number, fingerprint identification number, Social Security number, case or record number if applicable, case related data, or a combination of other personal identifiers including, but not limited to, date of birth and nationality.
ICE retains records in accordance with an applicable National Archives and Records Administration (NARA) General Records Schedule (GRS) or a NARA-approved agency-specific records control schedule. ICE retains records of arrests, detentions, and removals in the Enforcement Integrated Database and its
The Online Detainee Locator System (ODLS) uses an extract of Enforcement Integrated Database data about current detainees and detainees that were released during the last sixty (60) days. Records are retained in the Online Detainee Locator System for as long as they meet the extract criteria in accordance with the schedule, N1-567-11-7. The electronic Travel Document System (eTD) stores travel documents for twenty (20) years after the issuance of a travel document or denial letter in accordance with the schedule, DAA-0567-2017-0004. Alternatives to Detention program records are retained for seven (7) years after the individual has been removed from the Alternatives to Detention program and is no longer being monitored in accordance with the schedule, DAA-567-2018-0001-0001.
DHS/ICE safeguards records in this system according to applicable rules and policies, including all applicable DHS automated systems security and access policies. DHS/ICE has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
The Secretary of Homeland Security has exempted this system from the notification, access, and amendment procedures of the Privacy Act, and the Judicial Redress Act if applicable, because it is a law enforcement system. However, DHS/ICE will consider individual requests to determine whether or not information may be released. Thus, individuals seeking access to and notification of any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the Chief Privacy Officer and ICE FOIA Officer whose contact information can be found at
When seeking records about oneself from this system of records or any other Departmental system of records, an individual's request must conform with the Privacy Act regulations set forth in 6 CFR part 5. The individual must first verify their identity, meaning that they must provide their full name, current address, and date and place of birth. The individual must sign the request, and their signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, one may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Officer,
• Explain why they believe the Department would have information on them;
• Identify which component(s) of the Department they believe may have the information about them;
• Specify when they believe the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records.
If the request is seeking records pertaining to another living individual, the request must include an authorization from the individual whose record is being requested, authorizing the release to the requester.
Without the above information, the component(s) may not be able to conduct an effective search, and the individual's request may be denied due to lack of specificity or lack of compliance with applicable regulations.
For records covered by the Privacy Act or covered Judicial Redress Act records, individuals may make a request for amendment or correction of a Department record about the individual by writing directly to the Department component that maintains the record, unless the record is not subject to amendment or correction. The request should identify each record in question, state the amendment or correction desired, and state why the individual believes that the record is not accurate, relevant, timely, or complete. The individual may submit any documentation that would be helpful to support the request. If the individual believes that the same record is in more than one system of records, the request should state this belief and be addressed to each component that maintains a system of records containing the record.
See “Record Access procedure.”
The Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(j)(2), has exempted this system from the following provisions of the Privacy Act: 5 U.S.C. secs. 552a(c)(3), (c)(4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5), (e)(8); (f); and (g). Additionally, the Secretary of Homeland Security, pursuant to 5 U.S.C. 552a(k)(2), has exempted this system of records from the following provisions of the Privacy Act: 5 U.S.C. secs. 552a(c)(3); (d); (e)(1), (e)(4)(G), (e)(4)(H); and (f). When a record received from another system has been exempted in that source system under 5 U.S.C. secs. 552a(j)(2) or (k)(2), DHS will claim the same exemptions for those records that are claimed for the original primary systems of records from which they originated and claim any additional exemptions set forth here.
81 FR 72080 (November 18, 2016); 80 FR 24269 (April 30, 2015); 80 FR 11214 (March 2, 2015); 75 FR 23274 (May 3, 2010); 75 FR 9238 (March 1, 2010); 74 FR 20719 (May 5, 2009); 74 FR 5665 (January 30, 2009); 74 FR 4965 (January 28, 2009).
Office of the Assistant Secretary for Public and Indian
Notice.
This notice further extends the compliance date for HUD's National Standards for the Physical Inspection of Real Estate (NSPIRE) final rule for the Housing Choice Voucher (HCV), Project Based Voucher (PBV) and Section 8 Moderate Rehabilitation programs, and for the HOME Investment Partnerships Program (HOME) and Housing Trust Fund (HTF), Housing Opportunities for Persons With AIDS (HOPWA), Emergency Solution Grants (ESG) and Continuum of Care (COC) programs (“CPD programs”), until October 1, 2025. HUD is taking this action to allow Public Housing Authorities (PHAs), jurisdictions, participants, recipients, and grantees additional time to implement HUD's NSPIRE standards. This is the second extension of this compliance date.
HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as individuals with speech or communication disabilities. To learn more about how to make an accessible telephone call, please visit:
PHAs administering the HCV and PBV programs currently use the Housing Quality Standards (HQS) for inspections, which are defined at 24 CFR 982.401. The Economic Growth Regulatory Relief and Consumer Protection Act: Implementation of National Standards for Physical Inspection of Real Estate (NSPIRE) final rule (“NSPIRE final rule”) was published on May 11, 2023 (88 FR 30442). The NSPIRE final rule included amendments to 24 CFR parts 982 and 983 effective October 1, 2023. For CPD programs, the NSPIRE final rule included amendments to 24 CFR parts 92, 93, 570, 574, 576, and 578 to conform their various inspection requirements to NSPIRE and established an effective date for these amendments of October 1, 2023. In September 2023, HUD delayed the compliance date for CPD programs (88 FR 63971) and for the HCV and PBV programs (88 FR 66882) until October 1, 2024, to allow PHAs, jurisdictions, participants, recipients, and HUD grantees additional time for implementation.
Through this notice, HUD further delays the compliance date for CPD programs and for the HCV and PBV programs until October 1, 2025. HUD encourages any PHA, participating jurisdiction, or grantee that is ready to implement NSPIRE to do so at their earliest convenience. However, HUD has determined that additional time is necessary for some PHAs to implement NSPIRE for the HCV, PBV, and Moderate Rehabilitation (Mod Rehab) programs. This will provide PHAs with additional time to train staff and communicate with landlords and give HUD more time to provide additional technical resources needed for PHAs to transition to the NSPIRE standards. PHAs have reported to HUD that they are still recovering from the effects of the COVID-19 pandemic on their operations and are struggling to recruit and retain private landlords to participate in the HCV program. PHAs have also reported that staff time is being dedicated to administrative changes relating to the Housing Opportunity through Modernization Act (HOTMA), Public Law 114-201, 130 Stat. 782, which has impacted their ability to implement a new inspection protocol. Additionally, private software vendors have not finished their inspection products for PHAs, and HUD has not released its updated inspection software for HCV inspections.
HUD is also delaying the compliance date for CPD programs to allow jurisdictions, participants, recipients, and grantees that also administer housing or rental assistance, and that may rely on inspections performed under the HCV or PBV programs, to align their implementation timelines. As stated in the last compliance date extension for CPD programs, HUD intends to publish standards specific to each of the several CPD programs before the compliance date. These notices have not yet been published, and it will be a challenge for participating jurisdictions, recipients and grantees to revise their inspection procedures in time.
Only PHAs who will implement NSPIRE prior to the new compliance date of October 1, 2025, must notify HUD of the date on which they plan to transition to NSPIRE. This notification must be sent via email to
PHAs are reminded that the NSPIRE Standards
As stated in the previous compliance date extension for CPD, HOME participating jurisdictions and HTF grantees should prepare for the compliance date by updating property standard regulatory citations and requirements in written agreement templates with State recipients, subrecipients, and project owners, as
In addition, participating jurisdictions and HTF grantees that intend to comply with the changes in the NSPIRE final rule as of the effective date should review the deficiencies established in the NSPIRE Standards notice at 88 FR 40832 and compare these requirements to their existing rehabilitation and property standards and their inspection procedures and checklists. While HUD intends to publish a subset of the deficiencies in the NSPIRE Standards that are applicable to HOME and HTF projects, participating jurisdictions and HTF grantees that implement the changes in the NSPIRE final rule before publication of the subset of deficiencies for HOME and HTF must implement the full set of deficiencies in the NSPIRE Standards in their rehabilitation and ongoing property standards and policies and procedures. Further, participating jurisdictions and HTF grantees may not implement the changes in the NSPIRE final rule until such rehabilitation and ongoing property standards and policies and procedures are updated consistent with NSPIRE.
CoC and ESG program recipients and HOPWA grantees may apply the NSPIRE standards at 88 FR 40832 before October 1, 2025, provided that their program documents reflect the standards they are using and the date of transition to those standards. Otherwise, CoC and ESG recipients and HOPWA grantees that are not ready to make the transition to the new standards will be expected to adhere to the former program requirements until the new compliance date. However, when HUD issues the standards specific to the HOPWA, ESG and CoC programs, all grantees and recipients will be encouraged to prepare for the compliance date by updating their policies and procedures to reflect the program-specific standards.
HOPWA grantees are reminded of the requirements for installing carbon monoxide devices and smoke alarms as required by the Consolidated Appropriations Act, 2021 and 2023, respectively. HUD will update the NSPIRE Standard for the new smoke alarm requirements before the statutory compliance date of December 23, 2024.
Accordingly, HUD revises the October 1, 2024, compliance date for the changes made to 24 CFR parts 92, 93, 574, 576, 578, 882, 982, and 983 to October 1, 2025, at which time PHAs, jurisdictions, grantees, recipients, and participants subject to these parts must comply with the NSPIRE final rule. Until October 1, 2025, PHAs, jurisdictions, grantees, recipients and participants subject to these parts may instead choose to comply with the provisions of these parts that were amended by the NSPIRE final rule as they existed prior to October 1, 2023.
Fish and Wildlife Service, Interior.
Notice of availability; final environmental impact statement.
The U.S. Fish and Wildlife Service (Service) developed a proposed barred owl management strategy (strategy) to address the threat that the nonnative and invasive barred owl (
The Service's decision on the proposed management strategy will occur no sooner than 30 days after publication of the U.S. Environmental Protection Agency's notice of availability of the FEIS in the
You may obtain copies of the strategy and FEIS documents by any of the following methods:
•
•
Robin Bown, U.S. Fish and Wildlife Office, Oregon Fish and Wildlife Office (see
The U.S. Fish and Wildlife Service (Service) announces the availability of a final environmental impact statement (FEIS) addressing the proposed barred owl management strategy (strategy) developed to address the threat that the nonnative and invasive barred owl poses to two native western owl subspecies, the northern spotted owl (
This FEIS provides updates and clarifications to information presented in the draft environmental impact statement (DEIS), including revisions in response to issues raised in comments received during the public review period for that document, and identifies a preferred alternative. The Service, with input from 11 Federal and State cooperating agencies, has prepared this FEIS pursuant to the Council on Environmental Quality's (CEQ's) implementing NEPA regulations at 40 CFR parts 1500-1508, which became effective on May 20, 2022 (87 FR 23453; April 20, 2022).
Spotted owls are native to western North America. Competition from nonnative and invasive barred owls has been identified as a primary threat to the northern spotted owl, which is listed as threatened under the Endangered Species Act (ESA; 16 U.S.C. 1531
Barred owls, native to eastern North America, began to expand their range around 1900. Barred owls are larger and more aggressive than the northern spotted owl and the California spotted owl. Upon reaching the Pacific Northwest, barred owls quickly displaced spotted owls from their historic territories. Without management of barred owls, extirpation of northern spotted owls from major portions of their historic range is likely in the near future. While barred owls have not substantially impacted California spotted owl populations to date, the establishment of a small barred owl population in the northern Sierra Nevada mountains, and the history of the invasion and impacts on northern spotted owls following such expansion, demonstrates that barred owls are also a significant threat to the persistence of California spotted owls.
The barred owl is protected under the Migratory Bird Treaty Act (MBTA; 16 U.S.C. 703-712), which prohibits take of protected migratory bird species unless authorized by the Service through permit or regulation (50 CFR 21.10).
The purpose of this proposed action is to reduce barred owl populations to improve the survival and recovery of northern spotted owls and to prevent declines in California spotted owls from barred owl competition. Relative to northern spotted owls, the purpose is to reduce barred owl populations within selected treatment areas in the short term and to increase northern spotted owl populations in those treatment areas. Relative to the California spotted owl, the purpose is to limit the invasion of barred owls into the range of the subspecies and to provide for a rapid response to reduce barred owl populations that may become established.
As described in the FEIS, these actions are needed because barred owls compete with northern and California spotted owls. Competition from the barred owl is a primary cause of the rapid and ongoing decline of northern spotted owl populations. Due to the rapidity of the decline, it is critical that we manage barred owl populations to reduce their negative effects before northern spotted owls are extirpated from large portions of their native range. There is also a need to focus on limiting the invasion of barred owls into the California spotted owl range, as we expect that additional impacts to California spotted owl populations would be inevitable without barred owl management, and invasive species are very difficult to remove once established.
The proposed action, identified as the preferred alternative in the FEIS, is the issuance of a Migratory Bird Special Purpose permit under the MBTA (50 CFR 21.95) and implementation of the management strategy. The FEIS analyzed the proposed action, a no action alternative, and four alternatives to the proposed action, including the environmental consequences of each alternative. All action alternatives include issuance of an MBTA permit for management to reduce barred owl populations in areas within the northern spotted owl's range, and prevent establishment of barred owl populations within the California spotted owl's range. The locations and relative priorities for removal would vary by action alternative. None of the alternatives would require any entity to implement barred owl management; rather, they outline various combinations of management approaches, geographic areas, and other components that would allow for and guide management actions and the ability to prioritize areas of greatest need.
Six alternatives are analyzed in detail in the FEIS:
The Service is the lead agency for the NEPA process, including development of the FEIS. The following agencies were cooperating agencies in the NEPA process and provided input and assistance with the development of the FEIS: U.S. Forest Service (Regions 5 and 6), Bureau of Land Management (Oregon), Bureau of Land Management (California), National Park Service (Interior Regions 8, 9, 10, 12), Animal and Plant Health Inspection Service-Wildlife Services (U.S. Department of
As described above, if an action alternative is selected, the Service expects to obtain a Migratory Bird Special Purpose permit under the MBTA to implement the selected management strategy. Depending on the location and landowners involved in implementation of the management strategy, barred owl management could require additional Federal and State permits. We anticipate the potential need for implementors to acquire permits from the States of Washington, Oregon, and California to carry out the proposed barred owl removal actions under the proposed management strategy.
The Service published a notice of intent to prepare an EIS, opening a public scoping period on July 22, 2022 (87 FR 43886), which closed on August 22, 2022. A virtual public scoping meeting was held July 28, 2022. The Service prepared a DEIS and opened a 60-day public comment period on the DEIS and draft management strategy on November 17, 2023 (88 FR 80329). Two virtual public meetings were held, on December 4, 2023, and December 14, 2023, during the comment period, which ended on January 16, 2024. A total of 8,613 public comments were received during the DEIS comment period, including duplicates.
In preparing the FEIS, the Service considered all of the public comments on the DEIS and draft strategy in accordance with the requirements of NEPA (42 U.S.C. 4321
The Environmental Protection Agency (EPA) is charged under section 309 of the Clean Air Act with reviewing all Federal agencies' EISs and commenting on the adequacy and acceptability of the environmental impacts of proposed actions. Under the CEQ NEPA regulations, EPA is also responsible for administering the EIS filing process. EPA is publishing a notice in the
The Service will evaluate the associated documents and public comments received during the public comment periods in reaching a final decision on the proposed management strategy and issuance of an MBTA permit. At least 30 days after the FEIS is published, the Service expects to complete a record of decision pursuant to 40 CFR 1505.2, in accordance with applicable timeframes established in 40 CFR 1506.11. The Service expects to issue a record of decision in August 2024.
We provide this notice in accordance with the requirements of NEPA and its implementing regulations (40 CFR 1503.1 and 1506.6).
Fish and Wildlife Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing to renew information collection without change.
Interested persons are invited to submit comments on or before September 3, 2024.
Send your comments on the information collection request (ICR) by one of the following methods (please reference “1018-0185” in the subject line of your comments):
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Madonna L. Baucum, Service Information Collection Clearance Officer, by email at
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of
The Service's fall survey for the eastern population of the sandhill crane was established in 1979. It is implemented by State and Federal agencies and public volunteers from eight States in the Atlantic and Mississippi Flyways, as well as Ontario, Canada. Sandhill cranes are widely dispersed during the breeding and wintering seasons and are difficult to count. The optimal time to survey cranes is during the last week of October, when the majority of eastern population cranes breeding in Canada migrate to traditional staging grounds in the Great Lakes States (
The information collected through this survey is vital in assessing the relative changes in the geographic distribution of the species. We use the information primarily to inform managers of changes in sandhill crane distribution and population trends. Without information on the population's status, we might promulgate hunting regulations that:
• Are not sufficiently restrictive, which could cause harm to the sandhill crane population, or
• Are too restrictive, which would unduly restrict recreational opportunities afforded by sandhill crane hunting.
Notifications for the survey are sent to volunteers, and data results are entered into the data portal (
• Account setup process:
• Survey data submission:
Upon request, copies of the screenshots for the web survey are available by sending a request to the Service Information Collection Clearance Officer at
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.
We must receive comments by August 5, 2024.
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For more information, see Public Comment Procedures under
Brenda Tapia, by phone at 703-358-
We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
You may submit your comments and materials by one of the methods in
When submitting comments, please specify the name of the applicant and the permit number at the beginning of your comment. Provide sufficient information to allow us to authenticate any scientific or commercial data you include. The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) those that include citations to, and analyses of, the applicable laws and regulations.
You may view and comment on others' public comments at
If you submit a comment at
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(c) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
We invite comments on the following applications.
The applicant requests a permit to export two live, captive-born ring-tailed lemurs (
On November 21, 2022, we published a
On February 9, 2024, we published a
The applicant requests a permit to purchase in interstate commerce for one captive-born cheetah (
The applicant requests authorization to import biological samples of green sea turtle (
After the comment period closes, we will make decisions regarding permit issuance. If we issue permits to any of the applicants listed in this notice, we will publish a notice in the
We issue this notice under the authority of the Endangered Species Act
Fish and Wildlife Service, Interior.
Notice of availability; request for comment and information.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Cardinal Point Wind Farm, LLC (applicant), to amend its existing incidental take permit (ITP) under the Endangered Species Act, for its Cardinal Point Wind Project (project). The applicant requests that the ITP be amended to include an increased take authorization for the tricolored bat. We request public comment on the application, which includes the applicant's revised HCP, and the Service's draft supplemental environmental assessment, prepared pursuant to the National Environmental Policy Act. The Service provides this notice to seek comments from the public and Federal, Tribal, State, and local governments.
We will accept comments received or postmarked on or before August 5, 2024.
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Kraig McPeek, Field Supervisor, Illinois-Iowa Ecological Services Field Office, by email at
We, the U.S. Fish and Wildlife Service (Service), have received an application from Cardinal Point Wind Farm, LLC (applicant), to amend its existing incidental take permit (ITP) for four bat species under the Endangered Species Act, for its Cardinal Point Wind Project (project). The applicant requests that the ITP be amended to include an increased take authorization for the tricolored bat. The taking will be incidental to the otherwise lawful activities associated with the project. The applicant will continue the original conservation program to minimize and mitigate for the unavoidable incidental take as described in their habitat conservation plan (HCP) and will now include additional mitigation for the tricolored bat as well as updated adaptive management measures. The Service requests public comment on the application, which includes the applicant's revised HCP, and the Service's draft supplemental environmental assessment, prepared pursuant to the National Environmental Policy Act. The Service provides this notice to seek comments from the public and Federal, Tribal, State, and local governments.
Section 9 of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
On June 27, 2023, we published a
The applicant requests an amendment to the existing ITP for take of the federally endangered Indiana bat (
The Service requests public comments on the permit application, which includes an amended HCP, and a supplemental EA prepared in accordance with the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
The applicant's HCP and amendments describe the activities that will be undertaken to implement the project, as well as the mitigation and minimization measures proposed to address the impacts to the covered species. Pursuant to NEPA, the supplemental EA analyzes the impacts the ITP amendment would
The issuance of an ITP is a Federal action that triggers the need for compliance with NEPA. We prepared a draft supplemental EA that analyzes the environmental impacts on the human environment resulting from two alternatives: A no-action alternative, and the applicant's proposed action of amending the ITP.
The Service invites comments and suggestions from all interested parties during a 30-day public comment period (see
1. The direct, indirect, or cumulative effects that implementation of any alternative could have on the human environment;
2. Whether or not the significance of the impact on various aspects of the human environment has been adequately analyzed; and
3. Any other information pertinent to evaluating the effects of the proposed action on the human environment.
You may submit comments by one of the methods shown under
The Service will evaluate the permit amendment application and the comments received to determine whether the application meets the requirements of section 10(a) of the ESA. We will also reinitiate our intra-Service consultation pursuant to section 7 of the ESA to evaluate the effects of the proposed changes. After considering the above findings, we will determine whether the permit issuance criteria of section 10(a)(l)(B) of the ESA have been met. If met, the Service will issue the requested amended ITP to the applicant.
We provide this notice under section 10(c) of the ESA (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes to renew an information collection.
Interested persons are invited to submit comments on or before September 3, 2024.
Send your written comments on this information collection request (ICR) by mail to Darrin King, Information Collection Clearance Officer, U.S. Department of the Interior, Bureau of Land Management, Attention PRA Office, 440 W 200 S #500, Salt Lake City, UT 84101; or by email to
To request additional information about this ICR, contact Matt Blocker, Outdoor Recreation Planner, by email at
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps the BLM assess impacts of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BLM information collection requirements and provide the requested data in the desired format.
The BLM is especially interested in public comment addressing the following:
(1) Whether collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) determination of the accuracy of BLM's estimate of the burden for collection of information, including the validity of the methodology and assumptions used;
(3) methods to enhance the quality, utility, and clarity of the information to be collected; and
(4) how might the agency minimize the burden of information collection on those who respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice are a matter of public record. The BLM will include or summarize each comment in its request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying
An agency may not conduct or sponsor and, notwithstanding any other provision of law, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of availability.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) announces the availability of the Alaska Native Claims Settlement Act (ANCSA) 17(d)(1) Withdrawals Final Environmental Impact Statement (EIS). The BLM held public meetings on the Draft EIS and subsistence-related hearings to receive comments on the Draft EIS and the project's potential to impact subsistence resources and activities. The Final EIS considers those comments.
The BLM will publish the Record of Decision for the project no earlier than 30 days following the date the Environmental Protection Agency publishes its Notice of Availability of the Final EIS in the
The Final EIS and documents pertinent to this proposal are available for review on the BLM ePlanning project website at
Racheal Jones, BLM Project Manager, telephone (907) 290-0307; address ANCSA 17(d)(1) EIS, BLM Anchorage District Office, Attn: Racheal Jones, 4700 BLM Road, Anchorage, Alaska 99507; email
The U.S. Department of the Interior (DOI), BLM Alaska State Office, prepared this EIS to evaluate the effects of any Secretarial decision to revoke withdrawals established following enactment of ANCSA Section 17(d)(1) affecting the lands described in Public Land Order (PLO) Nos. 7899 through 7903. The potential revocation of these 17(d)(1) withdrawals is hereafter referred to as the 2021 Action. PLO Nos. 7900, 7901, 7902, and 7903, which would revoke withdrawals on lands in the Ring of Fire, Bay, Bering Sea-Western Interior, and East Alaska planning areas, respectively, were signed on January 15 and 16, 2021; however, they were never published in the
The 2021 Action under review is revocation of the ANCSA 17(d)(1) withdrawals as described in PLO No. 7899, 7900, 7901, 7902, and 7903, affecting approximately 28 million acres in total. This EIS evaluates the resource conditions on these lands and incorporates and describes additional coordination with other Federal agencies; State and local governments; Federally recognized Tribes; Alaska Native Corporations; and other stakeholders to ensure that the environmental analyses previously conducted are updated and expanded upon as appropriate. This additional analysis is necessary to ensure display of the impacts of revocation of the ANCSA 17(d)(1) withdrawals; to correct errors in the previous decision-making process regarding these withdrawals; and to ensure that opening these lands is consistent with the purposes of ANCSA 17(d)(1), which requires that “the public interest in these lands is properly protected,” including factors such as subsistence hunting and fishing, habitat connectivity, protection of cultural resources, and protection of threatened and endangered species. This evaluation is needed to make an informed public interest determination to support revocation in full, revocation in part, or retention in full of the ANCSA 17(d)(1) withdrawals.
The BLM considered alternatives that represent retention or revocation of the 17(d)(1) withdrawals and different configurations of the areas affected in each of the five planning areas (Bay, Bering Sea-Western Interior, East Alaska, Kobuk-Seward, and Ring of Fire). Each of the alternatives identifies 17(d)(1) withdrawals in the five planning areas as retained or revoked. The alternatives range from retaining
Section 810 of the Alaska National Interest Lands Conservation Act (ANILCA) requires the BLM to evaluate the effects of the alternatives presented in the Final EIS on subsistence uses and needs and to hold public hearings if it finds that any alternative may significantly restrict subsistence uses.
The BLM found in the evaluation of subsistence impacts that Alternatives B, C, or D, in combination with the cumulative case as analyzed in the Draft EIS, may significantly restrict subsistence uses in many communities. Therefore, the BLM held public hearings on subsistence resources and activities in conjunction with the public meetings on the Draft EIS in the vicinity of potentially affected communities. In consideration of public comments received on the Draft EIS and at the public hearings, the BLM revised the ANILCA Section 810 evaluation, published as Appendix C of the Final EIS, but did not change its “may significantly restrict subsistence uses” findings for the identified communities.
The input of Alaska Native Tribes and Corporations is of critical importance to this EIS. Therefore, during the NEPA process, the BLM consulted with potentially affected Federally recognized Tribes on a government-to-government basis, and with affected Alaska Native Corporations in accordance with Executive Order 13175, as well as Public Law 108-199, Div. H, sec. 161, 118 Stat. 452, as amended by Public Law 108-447, Div. H, sec. 518, 118 Stat. 3267, and other Department and Bureau policies.
Bureau of Land Management, Interior.
Notice of availability.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLMPA), the Bureau of Land Management (BLM) has prepared a proposed resource management plan (RMP) amendment and final environmental impact statement (EIS) for the Gunnison Sage-Grouse (
This notice announces the beginning of a 30-day protest period to the BLM on the proposed RMP amendment. Protests must be postmarked or electronically submitted on the BLM's ePlanning site within 30 days of the date that the Environmental Protection Agency (EPA) publishes its Notice of Availability (NOA) in the
The proposed RMP amendment and final EIS is available on the BLM ePlanning project website at
Instructions for filing a protest with the BLM for the Gunnison Sage-Grouse (
Gina Phillips, Project Manager, BLM Colorado, telephone 970-589-9852; BLM Southwest District Office, 2465 S. Townsend Ave., Montrose, CO 81401; email
The RMP amendment would change the following existing plans.
The Gunnison Sage-Grouse RMP amendment updates management decisions and actions to promote Gunnison sage-grouse recovery and maintain and enhance habitat, as identified in the 2020 U.S. Fish and Wildlife Service (USFWS) Recovery Plan, across the eight currently recognized populations in southwest Colorado and southeast Utah. Gunnison sage-grouse is federally listed as a threatened species under the Endangered Species Act (ESA) (16 U.S.C. 1531-1544).
The planning area spans portions of 19 Colorado Counties: Alamosa, Archuleta, Conejos, Costilla, Delta, Dolores, Garfield, Gunnison, Hinsdale,
The BLM's purpose consists of the following:
• Promote the recovery of the threatened Gunnison sage-grouse and maintain and enhance BLM-administered occupied and unoccupied habitat upon which the species depends, while continuing to manage the land wherever possible for multiple use and sustained yield;
• Ensure management actions on BLM-administered lands support conservation goals for Gunnison sage-grouse and their habitat;
• Ensure that BLM management aligns with current science and data; relevant Federal, State, and local decisions supporting recovery; the Department of the Interior Climate Action Plan; and the USFWS Final Recovery Plan for Gunnison Sage-Grouse and Recovery Implementation Strategy for Gunnison Sage-Grouse (
• Provide consistent guidance for addressing threats to Gunnison sage-grouse populations and their habitat.
This BLM action is necessary to accomplish the following:
• Address the range-wide downward population trend of Gunnison sage-grouse since 2014 and address issues related to land management that may affect occupied and unoccupied habitat;
• Respond to the ESA section 7(a)(1) (16 U.S.C. 1536(a)(1)) requirement that the BLM use its authority to further the purposes of the ESA by implementing management actions for the conservation of federally listed species and the ecosystems upon which they depend; and
• Respond to changing ecological and climate conditions affecting BLM-administered lands, including drought, habitat loss and fragmentation, reduced riparian areas, and more frequent wildland fires.
The BLM analyzed six alternatives in detail, including the no action alternative. This land use plan amendment addresses management actions impacting, or with the potential to impact, Gunnison sage-grouse and occupied and unoccupied habitat in the decision area. The decision area consists of approximately 2,182,660 acres of BLM-managed surface lands (1,951,440 acres in Colorado and 231,220 acres in Utah) and 2,852,390 acres of Federal subsurface mineral estate (2,563,220 acres in Colorado and 289,170 acres in Utah). Alternative A (No Action Alternative—Current Management) would continue current BLM management direction in the 11 administrative units in the planning area.
Alternative B would prioritize removing identified threats within occupied and unoccupied habitat and reduce impacts within the decision area, which includes a 4-mile buffer around habitat and potential linkage-connectivity areas to the maximum extent allowable. Alternative B contains two sub-alternatives for livestock grazing management actions in response to recommendations made in public scoping comments. Alternative B would designate all nominated Areas of Critical Environmental Concern (ACECs) that meet relevance and importance criteria.
Alternative C would minimize, mitigate, or compensate for impacts from resource uses and activities in occupied and unoccupied habitat. No new ACECs would be designated under Alternative C.
Alternative D would allocate resource uses and conserve resource values while sustaining and enhancing ecological integrity across the decision area and designate a specific subset of nominated ACECs. Conservation measures focus on occupied and unoccupied habitat that includes a 1-mile buffer around habitat and could extend to linkage-connectivity areas.
Alternative E considers adopting applicable management direction from the interagency Candidate Conservation Agreement for the Gunnison sage-grouse, Gunnison Basin Population.
Alternative F (proposed plan amendment) was developed in response to public comments on the draft RMP amendment/EIS and, similar to Alternative D, focuses conservation measures on occupied and unoccupied habitat. For all populations, Alternative F would apply buffers to all lek statuses (active, inactive, historic, unknown, occupied, and unoccupied) and manage with the objective of no increase in net surface disturbance; and it proposes management to increase available habitat for all Gunnison sage-grouse populations.
The BLM considered three additional alternatives but dismissed them from detailed analysis as explained in section 2.1.2.2 of the proposed RMP amendment/EIS.
The BLM published a notice of intent in the
After preparing the draft RMP amendment/EIS in coordination with 30 cooperating agencies and working with Tribes, the BLM announced the 90-day comment period through publication of its NOA in the
Based on public comments received on the draft RMP amendment/draft EIS, the BLM updated the proposed RMP amendment/final EIS (Alternative F) by incorporating management actions and allowable uses from Alternatives A, B, C, D, and E, including corrections and rewording for clarification of purpose and intent. Language throughout the document was revisited for readability and to meet the required page limits for an EIS. In consideration of comments received, the following management was updated in Alternative F:
• Uses would be avoided in buffer distances for all Gunnison sage-grouse lek statuses (active, inactive, historic,
• Objectives and management for net surface disturbance rather than disturbance caps were clarified;
• Management for Gunnison sage-grouse satellite populations was recognized as different in some aspects from the Gunnison Basin population under Lands and Realty and Recreation;
• Management in the current and proposed ACECs was refined, and a new Backcountry Conservation Area would be designated; and
• Appendices were also developed and expanded upon.
The BLM planning regulations state that any person who participated in the preparation of the RMP and has an interest that will or might be adversely affected by approval of the proposed RMP amendment may protest its approval to the BLM. Protest on the proposed RMP amendment constitutes the final opportunity for administrative review of the proposed land use planning decisions prior to the BLM adopting an approved RMP amendment. Instructions for filing a protest with the BLM regarding the proposed RMP amendment may be found online (see
Before including your phone number, email address, or other personal identifying information in your protest you should be aware that your entire protest—including your personal identifying information—may be made publicly available at any time. While you can ask us in your protest to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
On the basis of the record
The Commission instituted these investigations effective July 28, 2023, following receipt of petitions filed with the Commission and Commerce by Brooklyn Bedding LLC, Phoenix, Arizona; Carpenter Company, Richmond, Virginia; Corsicana Mattress Company, Dallas, Texas; Future Foam, Inc., Council Bluffs, Iowa; FXI, Inc., Radnor, Pennsylvania; Kolcraft Enterprises, Inc., Chicago, Illinois; Leggett & Platt, Incorporated, Carthage, Missouri; Serta Simmons Bedding, Inc., Doraville, Georgia; Southerland Inc., Antioch, Tennessee; Tempur Sealy International, Inc., Lexington, Kentucky; the International Brotherhood of Teamsters, Washington, DC; and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO, Washington, DC. The Commission scheduled the final phase of the investigations following notification of preliminary determinations by Commerce that imports of mattresses from Bosnia and Herzegovina, Bulgaria, Burma, Italy, Philippines, Poland, Slovenia, and Taiwan were being sold at LTFV within the meaning of § 733(b) of the Act (19 U.S.C. 1673b(b)). Notice of the scheduling of the final phase of the Commission's investigations and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to § 735(b) of the Act (19 U.S.C. 1673d(b)). It completed and filed its determinations in these investigations on June 28, 2024. The views of the Commission are contained in USITC Publication 5520 (June 2024), entitled
By order of the Commission.
National Endowment for the Arts, National Foundation on the Arts and the Humanities.
Notice of meetings.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 9 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference or videoconference.
See the
National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC 20506.
Further information with reference to these meetings can be obtained from David Travis, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chair of March 11, 2022, these sessions will be closed to the public pursuant to 5 U.S.C. 10.
The upcoming meetings are:
National Science Foundation.
Notice of permit applications received.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by August 5, 2024. This application may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314 or
Andrew Titmus, ACA Permit Officer, at the above address, 703-292-4479.
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 671), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas as requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
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Nuclear Regulatory Commission.
Notice; issuance.
The U.S. Nuclear Regulatory Commission (NRC) issued an exemption to South Texas Project Nuclear Operating Company permitting South Texas Project Electric Generating Station to shuffle (relocate) 10 already loaded model 37 multi-purpose canisters (MPC) with continuous basket shims (MPC-37-CBS) in January 2025 and to load two new MPC-37-CBS in the HI-STORM Flood/Wind MPC Storage System at its South Texas Project Electric Generating Station, Units 1 and 2 independent spent fuel storage installation in a storage condition where the terms, conditions, and specifications in the Certificate of Compliance No. 1032, Amendment No. 2, are not met.
The exemption was issued on June 26, 2024.
Please refer to Docket ID NRC-2024-0104 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Yen-Ju Chen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555; telephone: 301-415-1018; email:
The text of the exemption is attached.
For the Nuclear Regulatory Commission.
South Texas Project Nuclear Operating Company (STPNOC) is the holder of Facility Operating License Nos. NPF-76 and NPF-80, which authorize operation of the South Texas Project Electric Generating Station (STP), Units 1 and 2 in Bay City, Texas, pursuant to Part 50 of Title 10 of the
Consistent with 10 CFR part 72, subpart K, “General License for Storage of Spent Fuel at Power Reactor Sites,” a general license is issued for the storage of spent fuel in an Independent Spent Fuel Storage Installation (ISFSI) at power reactor sites to persons authorized to possess or operate nuclear power reactors under 10 CFR part 50. STPNOC is authorized to operate nuclear power reactors under 10 CFR part 50 and holds a 10 CFR part 72 general license for storage of spent fuel at the STP ISFSI. Under the terms of the general license, STPNOC stores spent fuel at its STP ISFSI using the HI-STORM Flood/Wind (FW) Multi-Purpose Canister (MPC) Storage System in accordance with Certificate of Compliance (CoC) No. 1032, Amendment No. 2.
By a letter dated May 7, 2024 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML24128A157), and
STPNOC currently uses the HI-STORM FW MPC Storage System under CoC No. 1032, Amendment No. 2, for dry storage of spent nuclear fuel in the MPC-37 at the STP ISFSI. Holtec International (Holtec), the designer and manufacturer of the HI-STORM FW MPC Storage System, developed a variant of the design with CBS for the MPC-37, known as MPC-37-CBS. Holtec performed a non-mechanistic tip-over analysis with favorable results and implemented the CBS variant design under the provisions of 10 CFR 72.48, “Changes, tests, and experiments,” which allows licensees to make changes to cask designs without a CoC amendment under certain conditions (listed in 10 CFR 72.48(c)). After evaluating the specific changes to the cask designs, the NRC determined that Holtec erred when it implemented the CBS variant design under 10 CFR 72.48, as this is not the type of change allowed without a CoC amendment. For this reason, the NRC issued three Severity Level IV violations to Holtec (ML24016A190).
STPNOC has near-term plans to shuffle (relocate) 10 already loaded MPC-37-CBS on the STP ISFSI pad in January 2025 and load two new MPC-37-CBS in the HI-STORM FW MPC Storage System in March 2025. While Holtec was required to submit a CoC amendment to the NRC to seek approval of the CBS variant design, such a process will not be completed in time to inform decisions for this near-term shuffling and loading campaign. Therefore, STPNOC submitted this exemption request in order to allow for the shuffling of 10 already loaded MPC-37-CBS in January 2025, and the future loading of two MPC-37-CBS in March 2025 at the STP ISFSI. This exemption is limited to the use of MPC-37-CBS in the HI-STORM FW MPC Storage System only for shuffling the 10 already loaded canisters and specific near-term planned loading of two new canisters using the MPC-37-CBS variant basket design.
Pursuant to 10 CFR 72.7, “Specific exemptions,” the Commission may, upon application by any interested person or upon its own initiative, grant such exemptions from the requirements of the regulations of 10 CFR part 72 as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
This exemption would allow STPNOC to shuffle (relocate) 10 already loaded and to load two MPC-37-CBS in the HI-STORM FW MPC Storage System, in January and March 2025, respectively, at its STP ISFSI in a storage condition where the terms, conditions, and specifications in the CoC No. 1032, Amendment No. 2, are not met. STPNOC is requesting an exemption from the provisions in 10 CFR part 72 that require the licensee to comply with the terms, conditions, and specifications of the CoC for the approved cask model it uses. Section 72.7 allows the NRC to grant exemptions from the requirements of 10 CFR part 72. This authority to grant exemptions is consistent with the Atomic Energy Act of 1954, as amended, and is not otherwise inconsistent with NRC's regulations or other applicable laws. Additionally, no other law prohibits the activities that would be authorized by the exemption. Therefore, the NRC concludes that there is no statutory prohibition on the issuance of the requested exemption, and the NRC is authorized to grant the exemption by law.
This exemption would allow STPNOC to shuffle (relocate) 10 already loaded MPC-37-CBS in January 2025 and to load two MPC-37-CBS in the HI-STORM FW MPC Storage System in March 2025, at the STP ISFSI in a storage condition where the terms, conditions, and specifications in the CoC No. 1032, Amendment No. 2, are not met. In support of its exemption request, STPNOC asserts that issuance of the exemption would not endanger life or property because a tip-over or handling event is administratively controlled, and that the containment boundary would be maintained in such an event. STPNOC relies, in part, on the approach in the NRC's Safety Determination Memorandum (ML24018A085). The NRC issued this Safety Determination Memorandum to address whether, with respect to the enforcement action against Holtec regarding this violation, there was any need to take an immediate action for the cask systems that were already loaded with non-compliant basket designs. The Safety Determination Memorandum documents a risk-informed approach concluding that, during the design basis event of a non-mechanistic tip-over, the fuel in the basket in the MPC-37-CBS remains in a subcritical condition.
STPNOC also provided site-specific technical information, including information explaining why the use of the approach in the NRC's Safety Determination Memorandum is appropriate for determining the safe use of the CBS variant baskets at the STP ISFSI. Specifically, STPNOC described that the analysis of the tip-over design basis event that is relied upon in the NRC's Safety Determination Memorandum, which demonstrates that the MPC confinement barrier is maintained, is documented in the updated final safety analysis report (UFSAR) for the HI-STORM FW MPC Storage System CoC No. 1032, Amendment 2, that is used at the STP site. STPNOC stated the transporter for handling of the HI-STORM FW MPC Storage System at the STP ISFSI meets the design requirements described in the CoC No. 1032 technical specifications 5.2.c.
Additionally, STPNOC provided specific information from STP's 72.212 Evaluation Report, Revision 3, indicating the calculated dose rate is in compliance with 10 CFR 72.104(a), “Criteria for radioactive materials in effluents and direct radiation from an ISFSI or MRS.” The analysis of a design basis accident scenario also demonstrates compliance with 72.106, “Controlled area of an ISFSI or MRS.” Specifically, STPNOC stated that, as described in section 12.2 of HI-STORM FW MPC Storage System UFSAR, there are no accidents which could significantly affect shielding effectiveness of the HI-STORM FW MPC Storage System. Coupled with the distance of the STP ISFSI to the site area boundary, STPNOC concluded that compliance with 72.104 and 72.106 is not impacted by approving this exemption request.
The NRC staff reviewed the information provided by STPNOC and concludes that issuance of the exemption would not endanger life or property because the administrative controls STPNOC has in place at the
For these reasons, the NRC staff has determined that under the requested exemption, the storage system will continue to meet the safety requirements of 10 CFR part 72 and the offsite dose limits of 10 CFR part 20 and, therefore, will not endanger life or property or the common defense and security.
The proposed exemption would allow STPNOC to shuffle (relocate) 10 already loaded MPC-37-CBS in the HI-STORM FW MPC Storage System on the ISFSI pad at the STP ISFSI in January 2025, and load two MPC-37-CBS in the HI-STORM FW MPC Storage System in March 2025 at the STP ISFSI, even though the CBS variant basket design is not part of the approved CoC No. 1032, Amendment No. 2. According to STPNOC, the exemption is in the public interest because being able to load the two MPC-37-CBS will ensure adequate full core offload margin that is necessary for completing refueling outages, implementing enterprise projects, and sustaining safe and efficient operation of the nuclear facilities. STPNOC stated that the full core offload margin was adversely impacted when STP could not load the two MPC-37-CBS canisters in its 2022 campaign. Further delay in the loading campaign would further impact the full core offload margin, and STPNOC would lose its ability to refuel the operating reactor. In addition, each fuel bundle contributes to the decay heat removal demand on the spent fuel pool cooling system, and removing the spent fuel bundles from the pool would allow for dispersion of the remaining heat load and reduce the consequence of a design basis accident associated with a loss of spent fuel pool cooling event. A crowded pool would also increase the likelihood of a fuel handling accident based on the additional fuel moves required to manage spent fuel pool loading with extra assemblies in the pool. STPNOC further stated that the shuffling (relocating) of the 10 already loaded MPC-37-CBS is necessary to optimize available space on the STP ISFSI pad for cask transporter maneuverability and minimize long-term damage to the STP ISFSI pad from cask transporter use, and thus ensures long-term safe storage of fuel-loaded spent fuel storage canisters. The shuffling also provides additional shielding to plant structures (such as warehouses and fabrication shops which are to the south of the STP ISFSI pad) by moving the spent fuel storage canisters with higher calculated dose rates (
STPNOC has considered procuring empty MPC-37 canisters from other utilities; however, STP's fuel assemblies are longer than fuel assemblies of other utilities that load the MPC-37 model. Therefore, procuring MPC-37 canisters from other utilities is not an option.
STPNOC has also considered procuring new MPC-37 canisters from the vendor and confirmed the approximate delivery would be in April 2025, which is after the planned March 2025 loading campaign. The loading campaigns are scheduled, budgeted, and planned several years in advance based on planned refueling outages, new fuel receipts, and other enterprise-level projects while considering the availability of specialty resources (equipment, vendors) to complete a campaign. Any delay to the March 2025 loading campaign would have cascading impacts to future new fuel receipts, refueling outages, and other enterprise projects. STPNOC asserted that delaying loading the two canisters beyond 2025 would result in loading these two canisters during the next scheduled loading campaign in 2028. Then, the number of canisters to be loaded would increase even more based on the new criticality analysis for the spent fuel pools to accommodate the planned storage of accident tolerant fuel.
For the reasons described by STPNOC in the exemption request, as supplemented, the NRC agrees that it is in the public interest to grant the exemption. If the exemption is not granted, in order to comply with the CoC, STPNOC would have to keep the loaded MPC-37-CBS at the current location on the STP ISFSI pad, and would have to keep spent fuel in the spent fuel pool since it is not permitted to be loaded into MPC-37-CBS. This would impact STPNOC's ability to manage the full core offload margin in STP's spent fuel pool, resulting in undesirable cascading impacts to new fuel receipts, refueling outages, other enterprise projects, and potentially safe reactor operation. Denying the exemption request could also challenge the cask transporter maneuverability on the STP ISFSI pad, and thus increase the use of a cask transporter on the STP ISFSI pad, which could increase the long-term damage to the STP ISFSI pad and result in likely longer personnel radiation exposure from increased cask transporter use.
Therefore, the staff concludes that approving the exemption is in the public interest.
The NRC staff also considered whether there would be any significant environmental impacts associated with the exemption. For this proposed action, the NRC staff performed an environmental assessment pursuant to 10 CFR 51.30. The environmental assessment concluded that the proposed action would not significantly impact the quality of the human environment. The NRC staff concluded that the proposed action would not result in any changes in the types or amounts of any radiological or non-radiological effluents that may be released offsite, and there would be no significant increase in occupational or public radiation exposure because of the proposed action. The environmental assessment and the finding of no significant impact was published on June 26, 2024 (89 FR 53452).
Based on these considerations, the NRC has determined that, pursuant to 10 CFR 72.7, the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. Therefore, the NRC grants STPNOC an exemption from the requirements of §§ 72.212(a)(2), 72.212(b)(3), 72.212(b)(5)(i), 72.212(b)(11), and 72.214 with respect to the shuffling of 10 MPC-37-CBS in the HI-STORM FW MPC Storage System in January 2025 and the future loading in the HI-STORM FW MPC Storage System of two MPC-37-CBS in March 2025.
This exemption is effective upon issuance.
Dated: June 26, 2024.
For the Nuclear Regulatory Commission.
Office of Personnel Management (OPM).
30-Day notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, OPM is proposing revisions to a currently approved information collection, USAJOBS Resume Builder and Application Profile, OMB Control No. 3206-0219.
Comments are encouraged and will be accepted until August 5, 2024. This process is conducted in accordance with 5 CFR 1320.1.
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this notice to
For specific questions related to this information collection activities, please contact. Human Resources Solution, Office of Personnel Management, 1900 E Street NW, Washington, DC 20415, Attention: Cori Schauer, or via electronic mail to
OPM, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the public with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Agency assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Agency's information collection requirements and provide the requested data in the desired format. OPM is soliciting comments on the proposed information collection request (ICR) that is described below. This information collection was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments.
The Agency is especially interested in public comment addressing the following issues: (1) whether this collection is necessary to the proper functions of the Agency; (2) whether this information will be processed and used in a timely manner; (3) the accuracy of the burden estimate; (4) ways in which the Agency may enhance the quality, utility, and clarity of the information to be collected; and (5) ways in which the Agency may minimize the burden of this collection on the respondents, including through the use of information technology. Written comments received in response to this notice will be considered public records.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
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This Notice will be published in the
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Kansas (FEMA-4774-DR), dated 04/28/2024.
Issued on 06/27/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Kansas, dated 04/28/2024, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 8.
This is an amendment of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-4776-DR), dated 04/30/2024.
Issued on 06/25/2024.
Alan Escobar, Office of Disaster
The notice of the President's major disaster declaration for the State of Oklahoma, dated 04/30/2024, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 07/31/2024.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Iowa (FEMA-4796-DR), dated 06/24/2024.
Issued on 06/24/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 06/24/2024, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 204156 and for economic injury is 204160.
U.S. Small Business Administration.
Amendment 9.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4781-DR), dated 05/17/2024.
Issued on 06/25/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Texas, dated 05/17/2024, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 08/15/2024.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Iowa (FEMA-4784-DR), dated 06/27/2024.
Issued on 06/27/2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street
Notice is hereby given that as a result of the President's major disaster declaration on 06/27/2024, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 20421C and for economic injury is 204220.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Minnesota (FEMA-4797-DR), dated 06/28/2024.
Issued on 06/28/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 06/28/2024, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 204346 and for economic injury is 204350.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4794-DR), dated 06/17/2024.
Issued on 06/27/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Florida, dated 06/17/2024, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections, and one new collection for OMB-approval.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
I. The information collection below is pending at SSA. SSA will submit it to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than September 3, 2024. Individuals can obtain copies of the collection instruments by writing to the above email address.
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SSA-711, or via an internet request through SSA's electronic Freedom of Information Act Xpress (FOIAXpress) website, to: (1) verify the wage earner is deceased; and (2) access the correct Social Security record. Respondents are members of the public requesting deceased individuals' Social Security records.
II. SSA submitted the information collections below to OMB for clearance. Your comments regarding these information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than August 5, 2024. Individuals can obtain copies of these OMB clearance packages by writing to the
The SHIPS study is a randomized controlled trial (RCT) designed to determine whether participation in Individual Placement and Support (IPS) improves the employment, income, health, and self-sufficiency of people who are recently homeless and living in supportive housing. The SHIPS study will mark the first study testing the effectiveness of implementing IPS in a supportive housing program. SSA hypothesizes that combining the two most successful evidence-based practices that separately address homelessness and supported employment will yield a single intervention that effectively addresses both. The intent of the SHIPS study is to measure the effectiveness of evidence-based IPS compared to the services provided by local WorkSource Centers broadly available to jobseekers in the Los Angeles area, The housing case managers will refer PATH clients interested in finding employment and will randomly assign participants to one of two groups:
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The primary goals of the SHIPS study are:
• To measure the effects of IPS participation on employment, income, health, and long-term self-sufficiency measured as a combination of housing stability, income, and receipt of DI and SSI benefits.
• To describe the study population in order to understand both the generalizability of the study's findings and the potential reasons for the observed effects.
• To explore the IPS implementation process to understand barriers and facilitators to high-fidelity IPS implementation in the supportive housing context.
Grantee researchers and SSA will use the information collected during this study to (1) assess the short-term and long-term effectiveness of the proposed intervention to improve employment, income, and self-sufficiency; (2) understand the implementation process; (3) provide detailed subgroup-specific data related to the effect of IPS.
The respondents are residents in supportive housing units operated by PATH who are unemployed and looking for employment.
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SSA offers two modalities for scheduling appointments: (1) an internet-based option (iAppointment), and (2) the Enhanced Leads and Appointment System (eLAS):
The respondents are individuals who are unable to use our internet or automated telephone systems because they failed the initial verification
Federal Aviation Administration (FAA), DOT.
Notice of funding opportunity.
The Department of Transportation (DOT), Federal Aviation Administration (FAA) announces the opportunity to apply for approximately $1 billion in FY 2025 discretionary funds for the Airport Terminal Program (ATP), made available under the Infrastructure Investment and Jobs Act of 2021 (IIJA), Pub. L. 117-58, herein referred to as the Bipartisan Infrastructure Law (BIL). The purpose of the ATP is to make annual grants available to eligible airports for airport terminal and airport-owned Airport Traffic Control Tower development projects that address the aging infrastructure of our nation's airports.
In addition, ATP grants will align with DOT's Strategic Framework FY2022-2026 at
Airport sponsors that wish to be considered for FY 2025 ATP discretionary funding should submit an application that meets the requirements of this Notice of Funding Opportunity (NOFO) as soon as possible, but no later than 5:00 p.m. Eastern time, July 31, 2024.
Submit applications electronically at
Jesse Carriger, Manager, BIL Branch APP-540, FAA Office of Airports, at (202) 267-3263 or our FAA BIL email address:
BIL established the ATP, a competitive discretionary grant program, which provides approximately $1 billion in grant funding annually for five years (Fiscal Years 2022-2026) to upgrade, modernize, and rebuild our nation's airport terminals and airport-owned Airport Traffic Control Towers (ATCTs). This includes bringing airport facilities into conformity with current standards; constructing, modifying, or expanding facilities as necessary to meet demonstrated aeronautical demand; enhancing environmental sustainability; encouraging actual and potential competition; and providing a balanced system of airports to meet the roles and functions necessary to support civil aeronautical demand. The FAA is committed to advancing safe, efficient transportation, including projects funded under the ATP. The ATP also supports the President's goals to mobilize American ingenuity to build modern infrastructure and an equitable, clean energy future. In support of the goals of Executive Order 13985,
The ATP falls under the project grant authority for the Airport Improvement Program (AIP) in 49 United States Code (U.S.C.) 47104. Per 2 Code of Federal Regulations (CFR) part 200—
Consistent with statutory criteria and Executive Order 14008,
The FAA will also consider projects that advance the goals of the Executive Orders listed under section E.2.
This NOFO announces up to $1,000,000,000, subject to availability of funds, for the Fiscal Year 2025 ATP. The ATP is a $5 billion grant program, distributed as approximately $1 billion annually for five years (Fiscal Years 2022, 2023, 2024, 2025, and 2026), subject to annual allocations limitations based on airport roles found in the published National Plan of Integrated Airport Systems (NPIAS), as updated with current year data. In general, the $5 billion in ATP grant funding is subject to the following annual award allocation limitations: not more than 55 percent shall be for large hub airports, not more than 15 percent shall be for medium hub airports, not more than 20 percent shall be for small hub airports, and not less than 10 percent shall be for nonhub and nonprimary airports.
The FAA will consider projects that increase capacity and passenger access; projects that replace aging infrastructure; projects that achieve compliance with the Americans with Disabilities Act (42 U.S.C. 12101,
Projects for relocating, reconstructing, repairing, or improving an airport-owned ATCT will also be considered. In addition to the considerations above, these projects will also be assessed based on overall impact on the National Airspace System, including age of facility, operational constraints, and nonstandard facilities.
The FAA will publish a NOFO that will announce its final round of funding made available, approximately $1 billion, in Fiscal Year 2026.
Eligible applicants are those airport sponsors normally eligible for Airport Improvement Program (AIP) discretionary grants as defined in 49 U.S.C. 47115. This includes a public agency, private entity, State agency, Indian Tribe or Pueblo owning a public-use NPIAS airport, the Secretary of the Interior for Midway Island airport, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau.
The Federal cost share of ATP grants is 80 percent for large and medium hub airports, and 95 percent for the remainder of airports eligible to receive ATP grants, which includes small hub, nonhub, and nonprimary airports.
All projects funded from the ATP must be:
i. Airport terminal development, defined in 49 U.S.C. 47102(28) as development of an airport passenger terminal building, including terminal gates; access roads servicing exclusively airport traffic that leads directly to or from an airport passenger terminal building; and walkways that lead directly to or from an airport passenger terminal building. Under the ATP, the
ii. On-airport rail access projects as set forth in Passenger Facility Charge (PFC) Update 75-21 (86 FR 48793, August 31, 2021); or
iii. Airport-owned ATCT that includes relocating, reconstructing, repairing, or improving the ATCT; and
iv. Justified based on civil aeronautical demand.
An application for ATP terminal or ATCT projects, FAA Form 5100-144,
Direct all inquiries regarding applications to the appropriate Regional Office (RO), Airports District Office (ADO) at
Applicants are required to submit FAA Form 5100-144,
The “Submit by Email” button at the bottom of the form will generate an email for the applicant to send to the FAA BIL Team at:
Applicants selected to receive an ATP grant will then be required to follow AIP grant application procedures prior to award, which include meeting all prerequisites for funding, and submission of Standard Form SF-424,
Airports covered under the FAA's State Block Grant Program or airports in a channeling act state should coordinate with their associated State agency on the process for who should submit an application, via the procedures listed above.
Applicants must address Administration and Departmental priorities in safety, climate change and sustainability, equity, and workforce development which are further defined in section E.1 Criteria.
Applicants must comply with 2 CFR part 25—
Once awarded, the FAA grant recipient must maintain the currency of its information in SAM until the grantee submits the final financial report required under the grant or receives the final payment, whichever is later. A grant recipient must review and update the information at least annually after the initial registration and more frequently if required by changes in information or another award term.
The FAA may not make an award until the applicant has complied with all applicable UEI and SAM requirements. If an applicant has not fully complied with the requirements by the time the FAA is ready to make an award, the FAA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a federal award to another applicant.
Non-Federal entities that have received a federal award are required to report certain civil, criminal, or administrative proceedings to SAM to ensure registration information is current and complies with federal requirements. Applicants should refer to 2 CFR 200.113 for more information about this requirement.
Airports that wish to be considered for FY 2025 ATP discretionary funding must submit an application that meets the requirements of this NOFO as soon as possible, but no later than 5:00 p.m. Eastern time on July 31, 2024. Submit applications electronically to
Not applicable.
All projects funded from the ATP must be airport terminal development or for relocation, reconstruction, repair, or improvement of an airport-owned Airport Traffic Control Tower, defined under section C-3 Project Eligibility. ATP funds may not be used to support or oppose union organizing.
Applications will only be accepted on FAA Form 5100-144 fillable PDF via email and must be received on or before July 31, 2024, 5:00 p.m. Eastern time. No other forms of applications will be accepted.
Applications for FY 2025 ATP will be rated using the following criteria:
i. Projects must meet eligibility requirements under the ATP, which includes terminal development (including multimodal terminal development) as defined in 49 U.S.C. 47102(28): on-airport rail access projects: or airport-owned ATCT relocation, reconstruction, repair, or improvements.
ii. The FAA will consider timeliness of implementation, with priority given to those projects, including “design only” projects, that can satisfy all statutory and administrative requirements for grant award by July 2025.
iii. Favorable consideration will be given to eligible and justified (based on civil aeronautical demand) terminal development projects (including multimodal terminal development), on-airport rail access projects, and ATCT projects that:
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iv. ATCT projects that relocate, reconstruct, repair, or improve an airport owned ATCT will also be assessed based on overall impact on the National Airspace System, including age of facility, operational constraints, and nonstandard facility conditions.
v. The FAA will provide a preference to projects that achieve a complete development objective, even if awards for the project must be phased; and prioritize projects that have received partial awards.
vi. The applicant should describe whether and how project delivery and implementation create good-paying jobs with the free and fair choice to join a union to the greatest extent possible; the use of demonstrated strong labor standards, practices and policies (including for direct employees, contractors, sub-contractors, and service workers on airport property); use of project labor agreements; distribution of workplace rights notices; union neutrality agreements; wage and/or benefit standards; safety and health standards; the use of Local Hire Provisions;
Applicants are encouraged to submit projects that meet as many of the above criteria as possible, but do not need to meet all criteria to be considered.
Federal awarding agency personnel will assess applications based on how well the projects meet the criteria in E.1, including project eligibility, justification, readiness, impact on the National Airspace System, and the availability of matching funds. The FAA will also consider how well projects advance the goals of the following Executive Orders, which are incorporated into the criteria under E.1.: the President's January 20, 2021, Executive Order 13990, “
Applications are first reviewed for eligibility, justification, and timeliness of implementation consistent with the requirements of this NOFO and the intent of the ATP. Applications are then reviewed for how well the proposed project(s) meets the criteria in E.1. and ranked by field and regional office staff. The top projects for each airport category (as outlined in BIL) are then assessed by a National Control Board (NCB). The NCB has representatives from each Region and Headquarters management. The NCB recommends project and funding levels to senior leadership.
Prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, the FAA is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313). An applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered. The FAA will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.206.
BIL awards are announced through a Congressional notification process and a DOT Secretary's Notice of Intent to Fund. The FAA RO/ADO representative will contact the airport with further information and instructions. Once all pre-grant actions are complete, the FAA RO/ADO will offer the airport sponsor a grant for the announced project. This offer may be provided through postal mail or by electronic means. Once this offer is signed by the airport sponsor, it becomes a grant agreement. Awards made under this program are subject to conditions and assurances in the grant agreement.
All grant recipients are subject to the grant requirements of the AIP, found in 49 U.S.C. Chapter 471. Grant recipients are subject to requirements in the FAA's
The U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) is charged with enforcing Executive Order 11246, section 503 of the Rehabilitation Act of 1973, and the Vietnam Era Veterans' Readjustment Assistance Act of 1974. OFCCP has a Mega Construction Project Program through which it engages with project sponsors as early as the design phase to help promote compliance with non-discrimination and affirmative action obligations. OFCCP will identify projects that receive an award under this notice and are required to participate in OFCCP's Mega Construction Project Program from a wide range of federally-assisted projects over which OFCCP has jurisdiction and that have a project cost above $35 million. DOT will require project sponsors with costs above $35 million that receive awards under this funding opportunity to partner with OFCCP, if selected by OFCCP, as a condition of their DOT award.
Each grant recipient must assure that it will comply with all applicable Federal statutes, regulations, executive orders, directives, FAA circulars, and other Federal administrative requirements in carrying out any project supported by the ATP grant. The grant recipient must acknowledge that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with the FAA. The grant recipient understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The grant recipient must agree that the most recent Federal requirements will apply to the project unless the FAA issues a written determination otherwise.
The grant recipient must submit the Certifications at the time of grant application and Assurances must be accepted as part of the grant agreement at the time of accepting a grant offer. Grant recipients must also comply with the requirements of 2 CFR part 200, which “are applicable to all costs related to Federal awards,” and which are cited in the grant assurances of the grant agreements. The Airport Sponsor Assurances are available on the FAA website at:
Grant recipients are subject to financial reporting per 2 CFR 200.328 and performance reporting per 2 CFR 200.329. Under the ATP, the grant recipient is required to comply with all Federal financial reporting requirements and payment requirements, including the submittal of timely and accurate reports. Financial and performance reporting requirements are available in
The grant recipient must comply with annual audit reporting requirements. The grant recipient and sub-recipients, if applicable, must comply with 2 CFR part 200, subpart F,
For further information concerning this notice, please contact the FAA BIL Branch via email at
All applicants, including those requesting full Federal share of eligible projects costs, should have a plan to address potential cost overruns as part of an overall funding plan.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before July 25, 2024.
Send comments identified by docket number FAA-2024-1318 using any of the following methods:
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William Andrews, (202) 267-8181, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information is used to identify foreign airmen in order to allow the agency to verify their foreign license when used to qualify for a U.S. certificate. Respondents are holders of foreign licenses wishing to obtain U.S. Certificates.
Written comments should be submitted by September 3, 2024.
Please send written comments:
Margaret Hawkins by email at:
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by FHWA and other Federal agencies.
This notice announces action taken by FHWA and other Federal agencies that are final. The actions relate to the Wilmington Riverfront Transportation Infrastructure Project (Project) proposed by the City of Wilmington, consisting of 0.5 mile of City grid network in City of Wilmington, New Castle County, Delaware. The actions grant licenses, permits, or approvals for the Project. The Revised Environmental Assessment (EA), Finding of No Significant Impact (FONSI) under the National Environmental Policy Act (NEPA), and other documents in the Project file provide details on the Project and FHWA's actions.
By this notice, FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before December 2, 2024. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Douglas Atkin, Division Administrator, Federal Highway Administration, 1201 College Park Drive, Suite 102, Dover, DE 19904, Telephone (302) 734-3819.
Notice is hereby given that FHWA and other Federal agencies have taken final agency actions by issuing approvals for the following highway project in Delaware: Wilmington Riverfront Transportation Infrastructure Project (Project).
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Revised EA and FONSI and the associated agency records. That information is available by contacting FHWA at the address provided above and can also be viewed and downloaded from the project website at:
This notice applies to FHWA agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. National Environmental Policy Act [42 U.S.C. 4321-4351].
2. Federal-Aid Highway Act [23 U.S.C. 109].
3. Clean Air Act [42 U.S.C. 7401-7671(q)].
4. Endangered Species Act [16 U.S.C. 1531-1544 and 1536].
5. Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)].
6. Migratory Bird Treaty Act [16 U.S.C. 703-712].
7. Bald and Golden Eagle Protection Act [16 U.S.C. 668-668c].
8. Section 106 of the National Historic Preservation Act of 1966, as amended [54 U.S.C. 306101
9. Civil Rights Act of 1964 [42 U.S.C. 2000d
10. Farmland Protection Policy Act [7 U.S.C. 4201-4209].
11. Clean Water Act (section 319, section 401, section 402, section 404) [33 U.S.C. 1251-1377].
12. Safe Drinking Water Act [42 U.S.C. 300(f)
13. Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 [42 U.S.C. 4601
14. Noise Control Act of 1972 [42 U.S.C. 4901
15. Resource Conservation and Recovery Act [42 U.S.C. 6901-6992(k)].
16. Comprehensive Environmental Response, Compensation, and Liability Act [42 U.S.C. 9601-9675].
17. Americans with Disabilities Act of 1990 [42 U.S.C. 12101].
18. Executive Order 11990 Protection of Wetlands.
19. Executive Order 11988 Floodplain Management.
20. Executive Order 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations.
21. Executive Order 11593 Protection and Enhancement of Cultural Resources.
22. Executive Order 11514 Protection and Enhancement of Environmental Quality.
23. Executive Order 13112 Invasive Species.
24. Executive Order 13166 Improving Access to Services for Persons with Limited English Proficiency.
25. Executive Order 13045 Protection of Children From Environmental Health Risks and Safety Risks.
26. Executive Order 14096 Revitalizing Our Nation's Commitment to Environmental Justice for All.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt 10 individuals from
The exemptions were applicable on June 22, 2024. The exemptions expire on June 22, 2026.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to
On May 16, 2024, FMCSA published a notice announcing receipt of applications from 10 individuals requesting an exemption from the hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested comments from the public (89 FR 42920). The public comment period ended on June 17, 2024, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(11).
The physical qualification standard for drivers regarding hearing found in § 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.
This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971), respectively).
FMCSA received no comments in this proceeding.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on relevant scientific information and literature, and the 2008 Evidence Report, “Executive Summary on Hearing, Vestibular Function and Commercial Motor Driving Safety.” The evidence report reached two conclusions regarding the matter of hearing loss and CMV driver safety: (1) no studies that examined the relationship between hearing loss and crash risk exclusively among CMV drivers were identified; and (2) evidence from studies of the private driver's license holder population does not support the contention that individuals with hearing impairment are at an increased risk for a crash. In addition, the Agency reviewed each applicant's driving record found in the Commercial Driver's License Information System, for commercial driver's license (CDL) holders, and inspections recorded in the Motor Carrier Management Information System. For non-CDL holders, the Agency reviewed the driving records from the State Driver's Licensing Agency. Each applicant's record demonstrated a safe driving history. Based on an individual assessment of each applicant that focused on whether an equal or greater level of safety would likely be achieved by permitting each of these drivers to drive in interstate commerce, the Agency finds the drivers granted this exemption have demonstrated that they do not pose a risk to public safety.
Consequently, FMCSA finds further that in each case exempting these applicants from the hearing standard in § 391.41(b)(11) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).
The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: (1) each driver must report any crashes or accidents as defined in § 390.5T; (2) each driver must report all citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 to FMCSA; and (3) each driver is prohibited from operating a motorcoach or bus with passengers in interstate commerce. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the exemption does not exempt the individual from meeting the applicable CDL testing requirements.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 10 exemption applications, FMCSA exempts the following drivers from the hearing standard; in § 391.41(b)(11), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
Maritime Administration, U.S. Department of Transportation.
Notice of availability; request for comments.
The Maritime Administration (MARAD) and the U.S. Coast Guard (USCG) announce the availability of the Final Environmental Impact Statement (FEIS) for the Texas GulfLink LLC (GulfLink) deepwater port license application for the export of oil from the United States to nations abroad. The GulfLink deepwater port license application describes a project that would be located approximately 26.2 nautical miles off the coast of Brazoria County, Texas. Publication of this notice announces a 45-day comment period ending on Monday, August 19, 2024, requests public participation in the final environmental impact review process and provides information on how to participate in the final environmental impact review process.
MARAD and USCG will hold one Final Hearing in connection with the GulfLink Application. The time and location for the Final Hearing will be published in a future notice. Public comments on the FEIS must be submitted to
Comments on the FEIS must be submitted to the U.S. Department of Transportation's Docket Management Facility or online to
Mr. Patrick W. Clark, Project Manager, USCG, telephone: 202-372-1358, email:
Please include “MARAD-2019-0093, GulfLink Comment” in the subject line of the message. For written comments and other material submissions, please follow the directions under the
On May 30, 2019, MARAD and USCG received a license application from GulfLink for all Federal authorizations required for a license to construct, own, and operate a deepwater port for the export of oil. The proposed deepwater port would be in Federal waters approximately 26.6 nautical miles off the coast of Brazoria County, Texas. Texas was designated as the ACS for the GulfLink license application.
A Notice of Application that summarized the GulfLink Deepwater Port License Application was published in the
MARAD and USCG held three virtual public comment meetings to receive comments on the Draft Environmental Impact Statement (DEIS). A Notice of Availability for the DEIS and Notice of Public Meeting was published in the
After the publication of the DEIS, GulfLink revised its deepwater license application in response to ongoing consultation with regulatory agencies and subsequently refined the design of the proposed deepwater port by adding a vapor control system into the design and operation of the proposed GulfLink deepwater port. A Notice of Availability; Notice of Virtual Public Meeting; Request for Comments for the Supplemental Draft Environmental Impact Statement (SDEIS) and was published in the
This Notice of Availability incorporates the aforementioned
GulfLink is proposing to construct, own, and operate a deepwater port terminal in the Gulf of Mexico to export domestically produced crude oil. Use of the deepwater port would include the loading of various grades of crude oil at flow rates of up to 85,000 barrels per hour (bph). The GulfLink deepwater port would allow for up to two Very Large Crude Carriers (VLCCs) or other crude oil carriers to moor at single point mooring (SPM) buoys and connect with the deepwater port via floating connecting crude oil hoses and a floating vapor recovery hose. The maximum frequency of loading VLCCs or other crude oil carriers would be one million barrels per day, 365 days per year.
The overall project would consist of offshore and marine components as well as onshore components as described below.
The GulfLink deepwater port offshore and marine components would consist of the following:
One 42-inch outside diameter, 28.1-nautical-mile long crude oil pipeline would be constructed from the shoreline crossing in Brazoria County, Texas, to the GulfLink deepwater port for crude oil delivery. This pipeline would connect the proposed onshore Jones Creek Terminal described below to the offshore platform.
The fixed offshore platform is connected to VLCC tankers for loading by two separate 42-inch diameter departing pipelines. Each pipeline will depart the fixed offshore platform, carrying the crude oil to a Pipeline End Manifold (PLEM) in approximately 104 feet of water depth located 1.25 nautical miles from the fixed offshore platform. Each PLEM is then connected to a Single Point Mooring (SPM) Buoy through two 24-inch cargo hoses. Two 24-inch floating cargo hoses will connect each SPM Buoy to the VLCC (or other crude oil carrier type). SPM Buoy 1 is positioned in Outer Continental Shelf Galveston Area Lease Block GA-423 and SPM Buoy 2 is positioned in Outer Continental Shelf Galveston Area Lease Block GA-A36.
Use of a dynamically positioned third-party Offshore Support Vessel, equipped with a vapor processing system to control the release of vapor emissions during the cargo loading operations of the proposed GulfLink deepwater port.
Onshore storage and supply components for the GulfLink deepwater port would consist of the following:
The Jones Creek Terminal also would include: Six electric-driven mainline crude oil pumps; three electric-driven booster crude oil pumps; one crude oil pipeline pig launcher; one crude oil pipeline pig receiver; two measurement skids for measuring incoming crude oil—one skid located on the Department of Energy's Bryan Mound facility, and one skid installed for the outgoing crude oil barrels leaving the tank storage to be loaded on the VLCC; and ancillary facilities to include an operations control center, electrical substation, offices, and warehouse building.
Two onshore crude oil pipelines would be constructed to support the GulfLink deepwater port and include the following:
One proposed incoming 9.1-statute mile long, 36-inch outside diameter pipeline connected to a leased 40-inch ExxonMobil pipeline originating at the Department of Energy's Bryan Mound facility with connectivity to the Houston market.
One proposed outgoing 12.1-statute mile long, 42-inch outside diameter pipeline connecting the Jones Creek Terminal to the shore crossing, where the offshore portion of this pipeline begins and supplies the proposed offshore GulfLink deepwater port.
As previously stated, the purpose of this notice is to announce the availability of the FEIS and the public comment period. Comments can be submitted through the Federal docket website:
The purpose of the FEIS is to analyze the direct, indirect, and cumulative environmental impacts of the proposed action, and to identify and analyze environmental impacts of a reasonable range of alternatives. The FEIS is currently available for public review and comment at the Federal docket website:
You are encouraged to provide comments on the proposed action and the environmental impact analysis contained in the FEIS for the proposed GulfLink deepwater port. These comments will inform MARAD's Record of Decision for the GulfLink deepwater license application. We encourage you to review the information on the project's docket located online at
Please see the information in the “
To ensure that your comments are correctly filed in the Docket, please include the docket number (MARAD-2019-0093) shown at the beginning of this document in your comments. If you are submitting comments electronically as a .pdf (Adobe Acrobat) File, MARAD
Please note that pursuant to the Data Quality Act, for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the Office of Management and Budget (OMB) and Department of Transportation (DOT) Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at
You may submit comments for the GulfLink deepwater license application (identified by DOT Docket Number MARAD-2019-0093) by any one of the following methods:
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, and/or a telephone number on a cover page so that we can contact you if we have questions regarding your submission. All submissions received must include the agency name and specific docket number to ensure your comment is filed in the appropriate docket. All comments received will be posted without change to the docket at
Comments that are not submitted directly to the Docket Management Facility using the methods specified and outlined within this
We are providing a comment period for the public to submit comments, which begins with the publication of this
If you wish for Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
No. MARAD and USCG will consider all substantive comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment if submitted on behalf of an association, business, labor union, etc.). For information on DOT's compliance with the Privacy Act, visit
By Order of the Maritime Administrator.
Departmental Offices, Treasury.
Notice.
For the period beginning July 1, 2024, and ending on September 30, 2024, the U.S. Immigration and Customs Enforcement Immigration Bond interest rate is 3 per centum per annum.
Rates are applicable July 1, 2024, to September 30, 2024.
Comments or inquiries may be mailed to Will Walcutt, Supervisor, Funds Management Branch, Funds Management Division, Fiscal Accounting, Bureau of the Fiscal Services, Parkersburg, West Virginia 26106-1328.
You can download this notice at the following internet addresses: <
Ryan Hanna, Manager, Funds Management Branch, Funds Management Division, Fiscal Accounting, Bureau of the Fiscal Service, Parkersburg, West Virginia 261006-1328; (304) 480-5120; Will Walcutt, Supervisor, Funds Management Branch, Funds Management Division, Fiscal Accounting, Bureau of the Fiscal Services, Parkersburg, West Virginia 26106-1328, (304) 480-5117.
Federal law requires that interest payments on cash deposited to secure immigration bonds shall be “at a rate determined by the Secretary of the Treasury, except that in no case shall the interest rate exceed 3 per centum per annum.” 8 U.S.C. 1363(a). Related Federal regulations state that “Interest on cash deposited to secure immigration bonds will be at the rate as determined by the Secretary of the Treasury, but in no case will exceed 3 per centum per annum or be less than zero.” 8 CFR 293.2. Treasury has determined that interest on the bonds will vary quarterly and will accrue during each calendar quarter at a rate equal to the lesser of the average of the bond equivalent rates on 91-day Treasury bills auctioned during the preceding calendar quarter, or 3 per centum per annum, but in no case less than zero. [FR Doc. 2015-18545]. In addition to this Notice, Treasury posts the current quarterly rate in Table 2b—Interest Rates for Specific Legislation on the Treasury Direct website.
The Deputy Assistant Secretary for Public Finance, Gary Grippo, having reviewed and approved this document, is delegating the authority to electronically sign this document to Heidi Cohen, Federal Register Liaison for the Department, for purposes of publication in the
Environmental Protection Agency (EPA).
Final rule.
This action finalizes the residual risk and technology review conducted for the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for the Coke Ovens: Pushing, Quenching, and Battery Stacks (PQBS) source category and the periodic technology review for the Coke Oven Batteries (COB) source category NESHAP. The EPA is finalizing a determination that risks due to emissions of hazardous air pollutants (HAP) from the PQBS source category are acceptable and that the current NESHAP provides an ample margin of safety to protect public health.
This final rule is effective on July 5, 2024, except for amendatory instruction 3, which is effective July 15, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register beginning July 5, 2024. The IBR of certain other material listed in the rule was approved by the Director of the Federal Register as of July 13, 2005.
The U.S. Environmental Protection Agency (EPA) has established a docket for this action under Docket ID Nos. EPA-HQ-OAR-2002-0085 for the Coke Ovens: Pushing, Quenching, and Battery Stacks (PQBS) source category and EPA-HQ-OAR-2003-0051 for the Coke Oven Batteries (COB) source category. All documents in the docket are listed on the
For questions about this final action, contact U.S. EPA, Attn: Donna Lee Jones, Sector Policies and Programs Division (MD-243-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5251; email address:
Under the technology review for the PQBS NESHAP, we are finalizing new maximum achievable control technology standards for unregulated HAP or sources of HAP and a 20 percent opacity limit for bypass/waste heat stacks at heat and/or nonrecovery (HNR) facilities. Under the technology review for the COB NESHAP, we are lowering the limits for leaking doors, lids, and offtakes at by-product (ByP) facilities to reflect improvements in practices, processes, or technology, a requirement for fenceline monitoring for benzene (as a surrogate for coke oven emissions) with a requirement to conduct a root cause analysis and corrective action upon exceeding an action level of benzene; a revised equation to estimate emissions from leaks of ByP oven doors; a requirement of zero leaking oven doors at HNR facilities and pressure monitoring in either oven or common tunnels. We are finalizing the removal of exemptions for periods of startup, shutdown, and malfunction consistent with a 2008 court decision, clarifying that the standards apply at all times; and the addition of electronic reporting for performance test results and compliance reports.
The Environmental Protection Agency (EPA) is finalizing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Coke Ovens: Pushing, Quenching, and Battery Stacks (PQBS) source category and NESHAP for the Coke Oven Batteries (COB) source category. The purpose of this final action is to fulfill the EPA's statutory obligations pursuant to Clean Air Act (CAA) sections 112(d)(2), (d)(3) and (d)(6) and improve the emissions standards for the COB and PQBS source categories based on information regarding developments in practices, processes, and control technologies (“technology review”).
In addition, this action fulfills the EPA's statutory obligations pursuant to CAA section 112(f)(2) to evaluate the
Under the residual risk review for the PQBS NESHAP pursuant to CAA section 112(f)(2), the EPA estimated the inhalation maximum individual risk (MIR) for cancer (based on current actual emissions levels) due to HAP emissions from PQBS sources is 9-in-1 million, and the MIR based on allowable emissions was slightly higher (10-in-1 million). All estimated noncancer risks are below a level of concern. Based on these risk results and subsequent evaluation of potential controls (
Under the technology review for the PQBS NESHAP pursuant to CAA section 112(d)(6), and consistent with the Louisiana Environmental Action Network (LEAN
Also under the technology review for the PQBS NESHAP pursuant to CAA section 112(d)(6), the EPA also is setting a 20 percent opacity limit for HNR B/W stacks to be measured weekly. The EPA did not identify any other cost-effective options to reduce emissions from currently regulated sources under the PQBS NESHAP.
The EPA is finalizing amendments under the technology review for the COB NESHAP pursuant to CAA section 112(d)(6) to include: (1) lower emission leak limits for ByP facility coke oven doors, lids, and offtakes; (2) for ByP facilities, continuous fenceline monitoring for benzene along with an action level for benzene (as a surrogate for coke oven emissions) and a requirement for root cause analysis and corrective actions (RCACA) if the action level is exceeded; (3) for HNR facilities, a requirement to demonstrate that there are zero leaks from their oven doors, as well as to ensure negative pressure in the ovens or common tunnels; and (4) a revised equation to estimate emissions from leaks of ByP oven doors that better represents the current industry emissions. The EPA did not identify any other cost-effective options to reduce emissions from currently regulated sources under the COB NESHAP.
We conducted a demographics analysis that indicates that the population within 10 kilometers (km) of the coke oven facilities with whole facility cancer risks greater than or equal to 1-in-1 million is predominantly white (62 percent versus 60 percent nationally). The population with whole facility cancer risks greater than or equal to 1-in-1 million is 30 percent African American compared to the national average of 12 percent. The population with whole facility cancer risks greater than or equal to 1-in-1 million living within 10 km of the two facilities located in Alabama is 56 percent African American, which is significantly higher than the national average. The population with whole facility cancer risks greater than or equal to 1-in-1 million also is above the national average for the percent of the population living below poverty (17 percent versus a 13 percent national average).
In addition, we are finalizing: (1) the removal of exemptions for periods of startup, shutdown, and malfunction (SSM) consistent with a 2008 court decision,
Cost impacts will occur due to the required source testing that includes: testing every 5 years to demonstrate compliance with the promulgated MACT floor standards for PQBS; weekly opacity testing of HNR B/W heat stacks; daily visible leak testing of HNR ovens doors; and fenceline monitoring at ByP facilities. The total costs for the rules are estimated to be $4.0 million per year for the 11 operating facilities ($2023), with $500,000 per facility, on average for the five HNR facilities and $250,000 per facility, on average, for the 6 ByP facilities. The testing to demonstrate compliance with the MACT limits is estimated to be $3.3 million total for the 11 operating facilities, with $300,000 per facility on average. The HNR B/W stack opacity testing is estimated to be $22,000 total for the five HNR facilities, with $4,400 per facility on average. The HNR daily door leak testing with EPA Method 303A is estimated to be $105,000 total for the five HNR facilities, with $21,000 per facility on average. The fenceline monitoring costs are estimated to be $640,472 for the six ByP facilities, with $107,000 per facility on average.
The EPA has not quantified any benefits associated with this final rule because all covered facilities are expected to already have HAP emissions levels that are below the final limits, based on facility data available to the EPA. However, the EPA anticipates that this final rule's new requirements will increase the likelihood of facilities successfully detecting any HAP emissions in excess of the specified limits, allowing for earlier corrective action and thus preventing pollution increases that could otherwise occur. The potential public health benefits associated with such prevention are difficult to estimate, given that they correspond to hypothetical scenarios of emissions beyond those indicated by current facility data, and are thus not quantified in EPA's analysis.
The EPA held a virtual public hearing on August 31, 2023, from 11:00 a.m. to 3:00 p.m. eastern daylight time (EDT), where 37 speakers provided oral comments. The EPA held a virtual webinar on September 14, 2023, from 6:00 p.m. to 7:30 p.m. EDT, where 34 registrants participated.
Table 1 of this preamble is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by the final action for the source category listed. To determine whether your facility is affected, you should examine the applicability criteria in the appropriate NESHAP. If you have any questions regarding the applicability of any aspect of this NESHAP, please contact the appropriate person listed in the preceding
In addition to being available in the docket, an electronic copy of this final action will also be available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this final action at:
Additional information is available on RTR website at
Under CAA section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit (the Court) by September 3, 2024. Under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.
Section 307(d)(7)(B) of the CAA further provides that only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. This section also provides a mechanism for the EPA to reconsider the rule if the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within the period for public comment or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule. Any person seeking to make such a demonstration should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, WJC South Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, with a copy to both the person(s) listed in the preceding
Section 112 of the CAA establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAP) from stationary sources. In the first stage, we must identify categories of sources emitting one or more of the HAP listed in CAA section 112(b) and then promulgate technology-based NESHAP for those sources. “Major sources” are those that emit, or have the potential to emit, any single HAP at a rate of 10 tons per year (tpy) or more, or 25 tpy or more of any combination of HAP. For major sources, these standards are commonly referred to as MACT standards and must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). In developing MACT standards, CAA section 112(d)(2) directs the EPA to consider the application of measures, processes, methods, systems, or techniques, including, but not limited to, those that reduce the volume of or eliminate HAP emissions through process changes, substitution of materials, or other modifications; enclose systems or processes to eliminate emissions; collect, capture, or treat HAP when released from a process, stack, storage, or fugitive emissions point; are design, equipment, work practice, or operational standards; or any combination of the above.
For these MACT standards, the statute specifies certain minimum stringency requirements, which are referred to as MACT floor requirements, and which may not be based on cost considerations. See CAA section 112(d)(3). For new sources, the MACT floor cannot be less stringent than the emission control achieved in practice by the best-controlled similar source. The MACT standards for existing sources can be less stringent than floors for new sources, but they cannot be less stringent than the average emission limitation achieved by the best-performing 12 percent of existing sources in the category or subcategory (or the best-performing five sources for categories or subcategories with fewer than 30 sources). In developing MACT standards, we must also consider control options that are more stringent than the floor under CAA section 112(d)(2). We may establish standards more stringent than the floor, referred to as “beyond-the-floor”, based on the consideration of the cost of achieving the emissions reductions, any non-air quality health and environmental impacts, and energy requirements.
In the second stage of the regulatory process, the CAA requires the EPA to
Coke ovens are chambers of brick or other heat-resistant material in which coal is heated to separate the gas, water, and tar in coal to produce coke, a fuel and source of carbon used in steelmaking. The coking process takes place at two types of facilities: (1) ByP facilities, where chemical by-products are recovered from coke oven emissions (COE), a CAA section 112(b) listed HAP, in coke oven exhaust at a co-located coke byproduct chemical recovery plant (CBRP); or (2) HNR facilities, where chemicals are not recovered (and, therefore, are called “nonrecovery” facilities), but heat may be recovered from the exhaust from coke ovens in a heat recovery steam generator (HRSG). There are 12 coke facilities in the United States (U.S.), with 11 of these currently operating. Seven of these facilities use the ByP process and five use the HNR process. Of the five HNR facilities, four have HRSGs and one does not. For additional background information on the source categories see the proposal preamble (88 FR 55858).
The COB NESHAP (40 CFR part 63, subpart L), promulgated in 1993, set emission limits (via limiting the number of seconds of visible emissions (VE)) from doors, lids, and offtakes at HNR facilities and any new ByP facilities to 0 percent leaking. The NESHAP for PQBS (40 CFR part 63, subpart CCCCC) were promulgated on April 14, 2003. The PQBS NESHAP established emissions standards for pushing coke out of ovens, quenching hot coke, and battery stacks of oven combustion.
For nonrecovery facilities,
For ByP facilities, the COB NESHAP regulates emissions occurring during the charging of coal into the ovens and from leaking oven doors, leaking topside charging port lids, and leaking offtake ducts. The charging process for ByP facilities includes opening the lids on the charging ports on the top of the tall narrow ovens and discharging coal from hoppers of a car that positions itself over the oven port and drops coal into the oven. The COB NESHAP limits the number of seconds of VE during a charge at ByP facilities, as determined by measurements made according to EPA Method 303.
The emissions from leaks at ByP batteries are regulated under the COB NESHAP by limits on the percent of doors, lids, and offtakes that leak COE. The emissions from leaks at HNR batteries are regulated under the COB NESHAP by limits on leaks only from oven doors. At HNR facilities, coal is charged into doors on one end of a long horizontal oven and pushed out the other end through another door at the other end of the oven. The offtake system at ByP facilities includes ascension pipes and collector main offtake ducts that are located on the top of the coke oven and battery. At HNR facilities, a common tunnel collects exhaust from the batteries and also is located on the top of the coke oven and battery. The common tunnels are equipped with afterburners that burn any remaining organics in the coke oven exhaust as it travels through the common tunnel. The common tunnel routes exhaust from the batteries to either HRSG or bypass/waste heat stacks depending on whether there are HRSG at the facility and whether the HRSG are operating.
The standards for the COB NESHAP are codified at 40 CFR part 63, subpart L. The COB NESHAP limits for leaks from doors, lids, and offtakes, and the requirements for charging are based on the regulatory “track” of the facilities. The facilities were required by CAA section 112(i)(8) to choose either the MACT track or the lowest achievable emissions rate (LAER) track by 1993 (58 FR 57898). There are no longer any ByP facilities on the MACT track operating today. Of the eleven operating coke facilities, all seven ByP facilities are on the LAER track and one HNR facility (SunCoke's Vansant plant) is on the LAER track; the remaining four HNR facilities are on the MACT track. Any future coke facilities of any type (HNR or ByP) would be on the MACT track,
The standards for the Coke PQBS NESHAP are codified at 40 CFR part 63,
On August 16, 2023, the EPA published a proposed rule in the
• 17 new MACT standards for previously-unregulated HAP pursuant to CAA sections 112(d)(2) and (3).
• Opacity limit of 10 percent for the HNR B/W stacks and requirement for daily observation of B/W stacks during charging to determine if VE are present.
• Zero leaking oven doors at HNR oven batteries, as determined by EPA Method 303A, which relies on observing VE emanating from the ovens; and also monitoring pressure both in the ovens and the common tunnel, instead of choosing one or the other points to measure pressure and instead of choosing either 0 oven door leaks or pressure monitoring, as the current rule allows.
• Fenceline monitoring for benzene (as a surrogate for COE) along with an action level for benzene and a requirement for RCACA if the action level is exceeded.
• Lower limits for allowable leaks from coke oven doors, lids, and offtakes at ByP facilities.
• Removal of exemptions for periods of SSM consistent with a 2008 court decision,
• Addition of electronic reporting for performance test results and compliance reports for both NESHAP.
This action finalizes the EPA's determinations for: (1) the CAA sections 112(f) and 112(d)(6) residual risk and technology review for the NESHAP for the PQBS source category; (2) the CAA section 112(d)(6) technology review for the NESHAP for the COB source category; and (3) other changes to the NESHAP, including the removal of SSM exemptions and addition of electronic reporting.
Considering the health risk information and factors discussed in the August 2023 proposed rule for the PQBS NESHAP, the EPA is finalizing a determination that the risks for this source category under the current NESHAP provisions are acceptable pursuant to CAA section 112(f). We did not identify any potential cost-effective controls or other measures to reduce risk further under our CAA section 112(f) risk review. Therefore, based on all of the information presented in the proposed rule and in this final rule preamble, we conclude that the current standards in the PQBS NESHAP provide an ample margin of safety to protect public health and are finalizing no changes based on the risk review. Furthermore, based on our screening assessment of environmental risk presented in section IV.B.4. of the August 2023 proposed rule preamble, we have determined that HAP emissions from the Coke Ovens: PQBS source category do not result in an adverse environmental effect, and we are finalizing that it is not necessary to set a more stringent standard to prevent an adverse environmental effect, taking into consideration costs, energy, safety, and other relevant factors.
As part of the technology review for the PQBS source category, we identified regulatory gaps (previously unregulated processes or pollutants) and are establishing new standards to fill those gaps, as described in section III.C. and IV.C. of this preamble. We also are requiring HNR B/W stacks to meet a limit of 20 percent opacity to be measured weekly at HNR B/W stacks and weekly at HRSG bypass stacks if operating.
For the COB source category, to address fugitive emissions at COB facilities as part of the technology review, we are finalizing a requirement for a work practice based on the results of fenceline monitoring for benzene at ByP facilities. The work practice has an action level of 7 microgram per cubic meter (
We are finalizing 18 MACT floor standards
We are finalizing the removal of exemptions for periods of startup, shutdown, and malfunction (SSM) largely as proposed, consistent with a 2008 court decision,
The EPA is promulgating that owners and operators of coke oven facilities, under both the PQBS NESHAP and COB NESHAP, submit electronic copies of required performance test reports, periodic reports (including fenceline monitoring reports), and periodic certifications through the EPA's Central Data Exchange (CDX) using the Compliance and Emissions Data Reporting Interface (CEDRI). A description of the electronic data submission process is provided in the memorandum
For the quarterly and semiannual compliance reports of the PQBS NESHAP source category and the semiannual compliance certification of the COB NESHAP source category, the promulgated rule requires that owners and operators use the appropriate spreadsheet template to submit information to CEDRI. A draft version of the promulgated templates for these reports is included in the docket for this action.
The electronic submittal of the reports addressed in this final rulemaking increases the usefulness of the data contained in those reports, is in keeping with current trends in data availability and transparency, further assists in the protection of public health and the environment, improves compliance by facilitating the ability of regulated facilities to demonstrate compliance with requirements and by facilitating the ability of delegated state, local, tribal, and territorial air agencies and the EPA to assess and determine compliance, and ultimately reduces the burden on regulated facilities, delegated air agencies, and the EPA. Electronic reporting also eliminates paper-based, manual processes, thereby saving time and resources, simplifying data entry, eliminating redundancies, minimizing data reporting errors, and providing data quickly and accurately to the affected facilities, air agencies, the EPA, and the public. Moreover, electronic reporting is consistent with the EPA's plan
These final rules are effective upon promulgation. The compliance date for the MACT standards for sources in the PQBS NESHAP is January 5, 2026. For the periodic MACT compliance testing, we are promulgating that periodic testing be conducted at the beginning of each permit cycle or every 5 years, whichever is shorter. The compliance date for opacity limits on HNR B/W stacks is July 7, 2025. The compliance date for achieving zero leaks from HNR oven doors and concurrent oven or tunnel pressure monitoring is July 7, 2025.
For fenceline monitoring provisions of the COB NESHAP, the compliance date to begin fenceline monitoring is July 7, 2025. The compliance date for complying with the revisions to the limits for allowable leaks from doors, lids, and offtakes is July 7, 2025.
The date for complying with the SSM changes is no later than July 5, 2024 with the exception of recordkeeping provisions. For recordkeeping under the SSM, facilities must comply with this requirement January 2, 2025. The date for complying with the recordkeeping provisions associated with malfunction events is January 2, 2025.
On January 5, 2022, the EPA published a final rule amending the list of HAP under the CAA to add 1-bromopropane (1-BP) in response to public petitions previously granted by the EPA. (87 FR 393). Consequently, as each NESHAP is reviewed, the EPA is evaluating whether the addition of 1-BP to the CAA section 112 HAP list impacts the source category. For the PQBS and COB source categories, we concluded that the inclusion of 1-BP as a regulated HAP would not impact the representativeness of the MACT standard because, based on available information, we have no evidence that 1-BP is emitted from this source category. No comments were received on this subject for the coke ovens NESHAP. As a result, no changes are being promulgated to the PQBS and COB NESHAP based on the January 2022 rule adding 1-BP to the list of HAP.
For each issue, this section provides a description of what we proposed and what we are finalizing for the issue, the EPA's rationale for the final decisions and amendments, and a summary of key comments and responses. For all comments not discussed in this preamble, comment summaries and the EPA's responses can be found in the
Pursuant to CAA section 112(f), the EPA conducted a residual risk review of the PQBS NESHAP and presented the results of this review, along with our proposed decisions regarding risk acceptability and ample margin of safety, in the August 16, 2023, proposed rule for the PQBS source category (88 FR 55858). The results of the risk assessment for the proposal are presented in table 2 of this preamble. More detail is in the residual risk technical support document
The results at proposal of the chronic baseline inhalation cancer risk assessment indicated that, based on estimates of current actual emissions, the MIR posed by the PQBS source category was 9-in-1 million driven by arsenic emissions, primarily from bypass/waste heat stacks. The total estimated cancer incidence estimated from this source category at proposal was 0.02 excess cancer cases per year, or 1 case every 50 years. No people were estimated to have inhalation cancer risks greater than 100-in-1 million; the population estimated to be exposed to cancer risks greater than or equal to 1-in-1 million was approximately 2,900. The estimated maximum chronic noncancer target organ-specific hazard index (TOSHI) from inhalation exposure for this source category was 0.1 for developmental effects from arsenic emissions The acute risk screening assessment of reasonable worst-case inhalation impacts indicated a maximum acute hazard quotient (HQ) of 0.6 based on the REL for arsenic.
The results of the inhalation risk assessment at proposal, considering MACT-allowable emissions, indicated that the cancer MIR was 10-in-1 million driven by arsenic emissions, primarily from HNR pushing and bypass/waste heat stacks. The total estimated cancer incidence from this source category based on allowable emissions was 0.05 excess cancer cases per year, or one excess case every 20 years. No people were estimated to have inhalation cancer risks above 100-in-1 million due to allowable emissions, and the population exposed to cancer risks greater than or equal to 1-in-1 million was approximately 440,000. In addition, the maximum modeled chronic noncancer TOSHI for the source category based on allowable emissions was estimated to be 0.2 (for developmental effects from arsenic emissions).
The maximum lifetime individual cancer risk at proposal posed by the 14 modeled facilities and based on whole facility emissions was 50-in-1 million, with COE from coke oven doors (a regulated source in the COB NESHAP), driving the whole facility risk. The total estimated cancer incidence based on facility-wide emission levels was 0.2 excess cancer cases per year. Regarding the noncancer risk assessment, the maximum chronic noncancer TOSHI posed by whole facility emissions was estimated to be 2 (for the neurological and thyroid systems as the target organs) driven by emissions of HCN from CBRPs, which are emissions sources not included within the source category (PQBS) addressed in the risk assessment for this rulemaking nor included in the COB NESHAP.
We weighed all health risk measures and factors, including those shown in table 2 of this preamble, in our risk acceptability determination and proposed that the risks posed by the PQBS source category under the current MACT provisions were acceptable.
Under the proposed ample margin of safety analysis, we again considered all of the health factors evaluated in the acceptability determination and evaluated the cost and feasibility of available control technologies and other measures (including the control devices and other measures examined under the technology review) that could be applied to further reduce risk. We also considered whether, taking into consideration costs, energy, safety, and other relevant factors, additional standards are required to prevent an adverse environmental effect.
We proposed that the current NESHAP provides an ample margin of safety to protect public health and that no additional standards are necessary to prevent an adverse environmental effect. Therefore, we did not propose amendments under CAA section 112(f)(2). However, we noted that the proposed beyond-the-floor (BTF) MACT limits for HNR B/W stacks would reduce the estimated MIR from 9-in-1 million to 2-in-1 million; and the population estimated to be exposed to cancer risks greater than or equal to 1-in-1 million would be reduced from approximately 2,900 to 390 with the proposed BTF MACT limits. The whole facility cancer MIR (the maximum cancer risk posed by all sources of HAP at coke oven facilities) would remain unchanged, at 50-in-1 million with BTF MACT limits, because the whole facility MIR was driven by the estimated actual
Changes were made to the risk emission model file used in the risk analyses which resulted in small changes in the estimated risk. These changes are listed below.
• Removed U.S. Steel Clairton batteries 1 through 3 and associated sources that were shut down in 2023.
• Removed Cleveland Cliffs' Follansbee, West Virginia, facility because it permanently closed in Spring 2022.
• Removed Cleveland Cliffs' Middletown, Ohio, facility because it permanently closed as of 2023.
• Corrected latitude and longitude values for two natural gas water heaters at Cleveland Cliffs' Warren, Ohio, facility.
• Corrected the angle of rotation for the byproduct plant fugitive source at Cleveland Cliffs' Warren, Ohio, facility.
• Replaced SunCoke's East Chicago facility's HRSG main stack (default) emissions with test data that was received too late to model for the proposal (received May 2023).
• Incorporated Hg emissions submitted for HNR HRSG main stacks from previous tests for SunCoke's Middletown and East Chicago (Cokenergy) facilities, which also changed the default average HNR HRSG main stack Hg emissions used for two other SunCoke facilities (SunCoke's Franklin Furnace and Gateway facilities).
• Incorporated Hg emissions data from previous tests submitted by SunCoke for HNR B/W stacks, which changed the Hg emissions for SunCoke's Middletown, Vansant, and East Chicago facilities.
• Revised emissions from door leaks based on revisions to new equation as a result of comments.
The results of the risk assessment performed for the final rule that incorporates the above changes are shown in table 3 of this section. The main difference in the risk estimated for the final rule and the proposed rule is the reduction in the whole facility MIR from 50 to 40-in-1 million, resulting primarily from removing two facilities (Cleveland Cliffs' Middleton, Ohio, and Follansbee, West Virginia, facilities) that shut down after years of being idle and removing three batteries (1,2,3) at U.S. Steel's facility in Clairton, Pennsylvania, that were permanently shut down. The baseline PQBS source category MIR remained at 9-in-1 million.
As noted in the proposal, we weigh a range of health risk measures and factors in our risk acceptability determination, including the cancer MIR, the number of persons in various cancer and noncancer risk ranges, cancer incidence, the maximum noncancer TOSHI, the maximum acute noncancer HQ, and risk estimation uncertainties (54 FR 38044, September 14, 1989). Under the current MACT standards for the PQBS source category, the revised risk results indicate that the MIR is 9-in-1 million, driven by emissions of arsenic. The estimated incidence of cancer due to inhalation exposures is 0.01 excess cancer case per year. No people are estimated to have inhalation cancer risks greater than 100-in-1 million, and the population estimated to be exposed to cancer risks greater than or equal to 1-in-1 million is approximately 2,600. The estimated maximum chronic noncancer TOSHI from inhalation exposure for this source category is 0.1 for developmental effects. The acute risk screening assessment of reasonable worst-case inhalation impacts indicates a maximum acute HQ of 0.6.
We conducted a revised assessment of facility-wide (or “whole-facility”) risk to characterize the source category risk in the context of whole-facility risk. The maximum lifetime individual cancer risk based on whole-facility emissions is 40-in-1 million with COE from coke oven doors (a regulated source in the COB NESHAP source category) driving the risk. The total estimated cancer incidence based on facility-wide emission levels is 0.1 excess cancer cases per year. No people are estimated to have inhalation cancer risks above 100-in-1 million due to facility-wide emissions, and the population exposed to cancer risk greater than or equal to 1-in-1 million is approximately 2.4 million people. The estimated maximum chronic noncancer TOSHI posed by whole facility emissions is 2 (for the neurological and thyroid systems as the target organs) driven by emissions of HCN from CBRPs, which are emissions sources not included within the source category. Approximately 10 people are estimated to be exposed to a TOSHI greater than 1 due to whole facility emissions. The acute risk screening assessment of reasonable worst-case inhalation impacts indicates a maximum acute HQ of 0.6.
We are not finalizing the proposed BTF limit for PM, as a surrogate for nonmercury HAP metals, pursuant to CAA sections 112(d)(2) and (3) for HRSG waste heat stacks in the PQBS source category for the reasons described in section IV.C.4. in this preamble, which would have achieved a reduction of the metal HAP emissions (
Under the ample margin of safety analysis, we did not change our proposal assessment that there were no cost-effective controls or measures to further reduce risks due to HAP emissions. Therefore, there are no changes for the final rule and the EPA concludes that the final rule provides an ample margin of safety to protect public health, that HAP emissions from the PQBS source category do not result in an adverse environmental effect, and that it is not necessary to set a more stringent standard to prevent an adverse environmental effect, taking into consideration costs, energy, safety, and other relevant factors.
We received a few comments on the risk review that offered other data and procedures to use rather than the EPA's protocol for risk assessment as well as comments on the risk to minority populations. The key comments on the risk review are summarized in this section along with the EPA's responses to the comments. Other comments received on the risk review are summarized along with the EPA's responses in the
We considered all of the health risk information and factors due to emissions from PQBS source category as well as the uncertainties in the risk assessment and have determined that the risks for this source category under the current PQBS NESHAP provisions are acceptable because the cancer MIR of 9-in-1 million is well below the presumptive level of acceptability (
Under the ample margin of safety analysis, we again considered all of the health factors evaluated in the acceptability determination and evaluated the cost and feasibility of available control technologies and other measures that could be applied to further reduce risk. We also considered whether, taking into consideration costs, energy, safety, and other relevant factors, additional standards are required to prevent an adverse environmental effect. We determined that no additional standards are required to provide an ample margin of safety to protect public health or to prevent an adverse environmental effect.
To fulfill the requirements of the
We proposed a 10 percent opacity limit for HNR B/W stacks during charging to be measured daily to limit the PM emissions from these sources.
As explained in the August 2023 proposed rule preamble, under the technology review for the PQBS NESHAP pursuant to CAA section 112(d)(6), the EPA did not identify any other cost-effective options to reduce emissions from currently regulated sources under the PQBS NESHAP apart from those requirements discussed in IV.B.1.a. and IV.B.1.b. of this section. Therefore, the EPA did not propose any other changes to the PQBS NESHAP pursuant to CAA section 112(d)(6). However, the EPA solicited comments regarding whether a 1-hour opacity standard would identify short-term periods of high opacity that are not identified from the current 24-hour standard of 15 percent opacity; and whether excessive COE are emitted from ovens after being pushed and before they are charged again (
As described in section IV.C. of this preamble, we are finalizing 17
The EPA also is finalizing a MACT floor work practice standard based on “good combustion,” pursuant to CAA section 112(h), that addresses the previously unregulated organic HAP of D/F, PAH, and VOHAP from battery stacks. Details regarding the final MACT standards are described in section IV.C. of this preamble.
In addition, the EPA is finalizing surrogate determinations to address the additional unregulated HAP of D/F, formaldehyde, and VOHAP from pushing; formaldehyde from HNR main stacks; and VOHAP from HNR B/W stacks. Details regarding these surrogates are described in section IV.C. of this preamble.
We also are finalizing a requirement for 20 percent HNR B/W stack opacity to reflect current permit requirements that is to be determined weekly for HNR waste heat stacks, and weekly for HRSG bypass stacks when operating longer than an hour in any week.
We are not setting 1-hour opacity standards for battery stacks in the final rule. We did not propose a 1-hour battery stack limit for comment and because there was a wide variation in the data collected from facilities for 1-hour opacity from battery stacks, without additional information we were not able to determine a 1-hour limit that considered all the factors which may influence short-term opacity and the impacts the limit might have on facilities not meeting a new 1-hour standard. Although we received three comments in favor of a 1-hour standard, one against, and one comment recommending a work practice to be triggered by an (unspecified) 1-hour opacity value, we are not setting a 1-hour battery stack opacity standard at this time as part of the Technology Review in this rulemaking as a development in practices, processes, and control technologies. We also are not including additional work practices or new control device requirements for soaking emissions in the final rule as part of the technology review. The short-term nature of soaking fugitives emissions would prevent accurate measurement of a limit for opacity, and the addition of a second collecting duct that routes standpipe COE exhaust to a control device would present safety hazards to workers and could prove to be impractical. We received one comment in favor of setting soaking standards and two comments against. See the
We proposed a fenceline monitoring work practice standard (for benzene, as a surrogate for COE). Fenceline monitoring refers to the placement of monitors along the perimeter of a facility to measure fugitive pollutant concentrations. The proposed fenceline monitoring work practice standard would have required owners and operators to monitor for benzene and conduct RCACA upon exceeding an “action level” concentration of 3 μg/m
Due to improvements in leak control at coke oven facilities, we proposed to lower the allowable door leak limits in the NESHAP under the technology review for the COB source category pursuant to CAA section 112(d)(6). We proposed for facilities with coke production capacity of greater than or equal to 3 million tpy of coke to lower the allowable leaking door limit from the current limit of 4 percent to 1.5 percent for tall leaking doors and from 3.3 percent to 1.0 percent for “not tall” leaking doors. These proposed standards would currently only apply to the U.S. Steel Clairton facility in Pennsylvania. For COB facilities that have coke production capacity less than 3 million tpy coke, we proposed an allowable leaking door limit of 3.0 percent leaking doors for all sizes of doors that is lower than the limit currently in the NESHAP of 4.0 and 3.3 percent leaking doors for tall and not tall doors, respectively.
We also proposed to lower the lid and offtake allowable leak limits in the NESHAP due to similar improvements in operation of these sources by the coke facilities. The current NESHAP includes limits of 0.4 percent leaking lids and 2.5 percent leaking offtakes; we proposed a revised limit of 0.2 percent for leaking lids and a revised offtake limit of 1.2 percent leaking offtakes.
The proposed changes to the leak limits were meant to ensure continued low emissions from doors, lids, and offtakes and reflect improvements in performance of the facilities to minimize leaks. We estimated that there would be no reductions in actual emissions and there would be no control costs, but the lower limits would reduce the allowable emissions. More details are provided in the August 16, 2023, proposed rule preamble.
The current NESHAP requires HNR facilities to demonstrate (with method 303) that facilities have zero leaks or demonstrate the ovens are under negative pressure. We proposed to revise the COB NESHAP for new and existing HNR doors (40 CFR 63.303(a)(1) and (b)(1)) to require zero leaks from oven doors at HNR coke batteries, as determined by EPA Method 303A, which relies on observing VE emanating from the ovens; and monitoring pressure both in the ovens and the common tunnel, instead of choosing one or the other points to measure pressure and instead of choosing either 0 oven leaks or pressure monitoring, as the current rule allows. We also proposed to add the requirement to measure both pressure in the ovens and common tunnels during the critical periods in the entire oven cycle to include, at minimum, during pushing, coking, and charging (but not necessarily continuously throughout the oven cycle).
We proposed a revised version of the equation than that historically had been used to estimate COE from leaking oven doors. The proposed revised equation provided more accurate estimates of COE from doors that reflected operation of any coke facility, not just the facility upon which the equation was derived, and includes facilities where advancements in preventing and reducing door leaks have occurred since 1981, which is when the equation was first developed. The proposed revised equation was as follows:
A summary of the proposed revised equation and the rationale for its development are provided in the August 16, 2023, preamble. A more detailed explanation can be found in the memorandum prepared for the proposal,
We proposed a new opacity limit of 10 percent on the HNR facilities' HNR B/W stacks and to require a daily observation of all bypass or waste heat stacks during charging to determine if VE are present.
As a result of comments, we revised the modeling procedures used to determine the fenceline action level by including additional offsite receptors in our modeling to more appropriately assess the maximum concentrations from irregular-shaped facility properties. Due to the unique layout of the coke oven sources and the elongated shape of their fencelines, the spatial resolution of the default receptor grid was not sufficient to accurately estimate the maximum ambient concentration. This change in procedures resulted in a change to the action level from 3
We revised the proposed leak limits for doors, lids, and offtakes based on information and data obtained from a number of ByP facilities in late 2023 on the variability of leaks in daily rolling 30-day averages basis, including Cleveland Cliffs' Warren, Ohio, and Burns Harbor, Indiana, facilities, EES Coke in Michigan, and U.S. Steel Clairton in Pennsylvania; and based on additional information and data provided by email from David Alor (of COETF) on February 5, 2024 and March 22, 2024 regarding the maximum 30-day rolling averages across facilities for the period 2018-2023. These data are available in the docket for this action.
Using the available data, we compared the maximum 30-day rolling averages with the maximum annual averages and developed adjustment factors to account for variability. Then, we multiplied the adjustment factors by the maximum annual average for each door type to obtain the revised leak limits. In this final rule, we are promulgating the revised leak limits shown in table 4 and in the revised memorandum prepared for the final rule,
We are not requiring pressure monitoring in both common tunnels and ovens in the final rule but instead are allowing a choice between the two as in the current rule because we did not receive any comments in support of requiring both and we received comments pointing out the expense and safety hazards of oven pressure monitoring. We are requiring the pressure monitoring in either ovens or tunnels to be performed at minimum during pushing, charging, and coking. For the final rule, we also are requiring zero leaks from HNR oven doors with daily leak testing, as determined by EPA Method 303A, along with pressure monitoring in either the common tunnels or the ovens during pushing, charging, and coking.
We revised the proposed equation to estimate COE emissions from leaking doors based on VE test data from two facilities that the EPA received in 2022 and combined these data with VE test results from 1981, which was when the original equation first was developed. The 2022 VE testing was performed at Cleveland Cliffs' Burns Harbor and U.S. Steel's Clairton facilities and included simultaneous yard and bench VE tests at the coal-side and coke-side of two batteries at each facility. The 1981 data also had been collected at U.S. Steel Clairton. In addition, we received a comment that the equation did not account for the case where no VE from oven doors is observed from the yard but VE from ovens is observed from the bench. A linear regression analysis of the combined 1981 and 2022 data provided a revised equation with an intercept that is only dependent on the number of doors (ND) and not dependent on yard observations and provides an estimate of emissions when yard VE is zero. The final equation is as follows:
For the final rule, we revised the proposed 10 percent opacity limit for HNR B/W stacks during charging with daily testing to 20 percent and moved the requirement from the COB rule (subpart L) to the Coke PQBS rule (subpart CCCCC). We also changed the proposed daily testing requirement to weekly. For HNR facilities without continuous bypass, weekly opacity testing is only required if the bypass event continues for more than an hour.
The key comments on the proposed results of the technology review are summarized in this section along with the EPA's responses to the comments. Other comments received on the technology review not included here are summarized along with the EPA's responses in the
We received many comments on fenceline monitoring with comments both in favor of the proposed requirement and comments that were opposed to the requirements or requested significant changes.
The fenceline monitoring provisions in the final rule can be thought of as consisting of two elements, one being measurement and reporting of fenceline concentrations, the other being compliance with the RCACA, the latter being the work practice element of the rule. To the extent the commenters assert that the EPA's authority is lacking in regard to the requirements to measure and report fenceline concentrations resulting from emissions from CBRPs, the EPA disagrees. By its own terms, the commenter's argument regarding the limits of CAA section 112 authority to non-listed source categories pertains only to “emission standards,” which as defined in CAA section 302(k) are requirements that “limit[ ] the quantity, rate, or concentration of emissions . . .” The commenter's own reasoning, therefore, does not suggest that the EPA may not require monitoring of non-listed CBRPs.
In any case, CAA section 114 independently provides ample authority to require monitoring of CBRPs. Relevant to the fenceline monitoring provisions of this rule, CAA section 114 gives the EPA authority to require the owner or operator of a source of emissions to monitor emissions, including by periodic sampling, either for the purpose of assisting in the development of a CAA section 112 standard, or to determine compliance with an existing CAA section 112 standard. The fenceline monitoring provisions in the final rule will serve both purposes. It will inform the EPA's consideration of whether and how to further regulate emissions from CBRP. It may also provide information relevant to determining compliance with 40 CFR part 61, subpart L applicable to CBRP. Fenceline monitoring will further these goals notwithstanding that the final rule does not require corrective action at CBRP, and also notwithstanding that coke oven facilities may seek approval of an SSMP that may reduce the likelihood of needing to perform a root cause analysis at the CBRP.
Regarding requirements pertaining to the RCACA work practice element of the rule, 40 CFR 63.314(d)(3) of the final rule provides that corrective action will not be required at sources not subject to a regulation codified in part 63. At present, CBRP are not subject to a regulation codified in part 63, and as a consequence there is no requirement to conduct corrective action at CBRP until a part 63 regulation is promulgated for that source category.
The final rule also provides an opportunity for facilities to develop an SSMP, subject to review and approval by the EPA, allowing a facility to account for the contribution to measured fenceline concentrations due to benzene emissions from offsite or co-located sources not subject to a regulation codified in 40 CFR part 63 (such as CBRP). The owner/operator may choose to develop a technically-sound monitoring plan to isolate and distinguish emissions from CBRP from other emission sources. The SSMP may be used to correct the measured concentration at impacted sample locations, thereby reducing the number of exceedances of the action level caused by the CBRP, and also reducing the number of root cause investigations pointing to the CBRP. The EPA recognizes that, similar to refineries where the correction for onsite sources is also allowed, development of a monitoring program to implement the SSMP for onsite sources is expected to be complicated. We have also extended the time for the EPA to review the SSMP to 120 days from 90 days to account for the increased complexity of SSMP as a result of the inclusion of these onsite sources. Real-time monitoring techniques, such as open-path monitoring and sensor networks, could potentially be useful to characterize emissions from such proximate sources. Further, if information from a root cause investigation demonstrates that a primary or other contributing cause of an exceedance of the corrective action level are due to emissions from a CBRP, no corrective action would be required to address those causes at the non-listed CBRP operations beyond those that may be required under current regulations (40 CFR part 61, subpart L, or other applicable regulatory requirements). For example, if during the root cause investigation the primary or other contributing cause(s) is traced to a leak, as defined by 40 CFR part 61 subpart L, in the connections or seals of a control system, that leak would be required to
The commenter continued that fugitive HAP emissions monitoring conducted at one of SunCoke's plants for ten years demonstrates that there is no impact on ambient HAP levels, that any emissions are below risk-based screening levels, and that the state agency agreed with this determination. The commenter contended in determining whether to adopt fenceline monitoring requirements in the current rulemaking, the EPA selected five coke facilities—four ByP facilities and one HNR facility. The commenter asserted that the proposal inappropriately grouped ByP and HNR facilities together as subject to fenceline monitoring despite significant differences in potential for fugitive emissions.
One commenter contended the predicted maximum benzene concentrations for ByP plants range from 0.3 to 3
Another commenter contended the EPA did not remark upon the discrepancy of benzene concentrations between ByP and HNR facilities; the benzene fenceline concentrations detected at ByP facilities were 90 to 4,000 percent higher than the levels detected at SunCoke's Haverhill facility in Franklin Furnace, Ohio. The absence of any necessity for fenceline monitoring at HNR facilities was demonstrated by the company's Haverhill facility, which performed almost 10 years of monitoring for PAH and VOCs as required by the facility's Title V operating permit. The permit called for sampling at three ambient monitoring locations near the plant (one upwind, one downwind, and one adjacent to the entry gate to the plant). The sampling was initiated when the plant was being built in late 2004, continued as the plant became operational in mid-2005, and continued until the Ohio EPA terminated the requirements for monitoring (in 2013 for PAH and in 2014 for VOC) because the HAP monitoring data demonstrated that Haverhill had no impact on ambient HAP levels and emissions were below risk-based screening levels. (Commenter cites “Letter from Ohio EPA to Haverhill Coke Company, July 14, 2014”.)
• Physical plant boundary including each fenceline “reach” on a properly-drawn scaled map, showing all coke-making and related operations as well as the land uses beyond the plant, adjacent to each reach of the fenceline.
• Types of pollutants emitted by the plant—for which the starting point is the collection of 2016 and 2022 (ICR) data, as supplemented by ongoing testing. This will include a range of VOCs and HAPs, PAHs, PM
• Sampling approach to initially measure all potential HAP emissions at each fenceline reach, and especially for those reaches where there is potential for community exposure if pollutants escape the plant boundary—at least for a period of 1 year.
• Potential reduction of the list of measured HAP that are potentially emitted at each fenceline reach, as needed, based on the first year of data collection.
• Proper frequency of sampling at the critical fenceline reaches. For example, if benzene or naphthalene are identified as the potential pollutants for adjacent community exposures, the plan should include continuous measurements using open path methods as opposed to periodic sorbent tube collection. Continuous measurements will provide the data on short-term variability of such impacts as opposed to a 2-week or similar average using sorbent tubes. Refineries in California have successfully implemented such continuous fenceline monitoring for many years and the EPA can readily access how these have been implemented.
• Collection of continuous meteorological data in order to assist in data evaluation—
Another commenter asked how the monitoring requirements that support the exclusion of benzene from offsite sources can be made more transparent and enforceable, particularly if the SSMP is the method for excluding benzene from offsite sources. The commenter requested that the EPA revise the proposed rule text for fenceline monitoring (40 CFR 63.314(i)(1)(ii)) accordingly to make this requirement more transparent and enforceable. The commenter suggested the following text as a replacement: “. . . . . identify the location of the additional monitoring stations that must be used to determine the uniform background concentration and the near-field source concentration contribution. Modeling may not be used in lieu of monitoring to identify near-field sources that an SSMP applicant alleges contribute significantly to fenceline benzene levels at the applicant's facility.”
The EPA acknowledges the feedback from the commenter about making the language for near field source correction of upwind contributions more transparent and enforceable in the final rule. The rule requires an owner or operator to submit a SSMP to the EPA for review and approval when near-field offsite upwind sources or certain onsite sources are being accounted for. The EPA will approve or disapprove the SSMP in writing within 120 days of receiving a complete SSMP submittal. The EPA agrees with the commenter that more specificity should be provided in the SSMP and has chosen to revise the final rule to include more prescriptive language to define the requirements of the SSMP and to harmonize the approach for this rule with other NESHAPs.
One commenter stated the proposed rule does not include hydrogen sulfide fenceline monitoring. The commenter argued that the EPA has failed to account for its own data about how damaging these facilities are. The commenter stated that in 2018, the EPA produced a “Geospatial Monitoring of Air Pollution Report” (October 31, 2018) after conducting some fenceline monitoring over 6 days along one side of Middletown Works (which then had an operating coke plant). The commenter indicated that the EPA concluded “These mobile and stationary data indicate a potential acute human health hazard.” The commenter asserted that these hydrogen sulfide results show
Another commenter stated that benzene is an adequate surrogate for some HAP, but not for inorganic compounds, and indicated that the EPA should require fenceline monitoring of arsenic. This commenter requested that the EPA add a requirement for fenceline monitoring of arsenic. The commenter contended that while benzene seems to be a good indicator for hydrocarbons such as BTEX or PAH, it is not clear that it is also a surrogate for inorganic pollutants. The commenter stated that the U.S. Geological survey examined arsenic levels in coal, finding a broad range of mean concentrations from 1.5 ppm to 71 ppm, depending on the source (
The commenter stated that the EPA identified arsenic as the leading cause for cancer and chronic health risks from COE but benzene has not been proven to be an adequate surrogate for arsenic levels. According to the commenter, adding a fenceline monitoring requirement for arsenic would be feasible and simple to implement. The commenter said that the EPA has a number of methods to determine metal concentration in ambient air that could be used for the fenceline monitoring (see
Arsenic requires a different monitoring approach with much higher costs, both for the analytical tests and for installation, and requires electricity at each sampling location. Benzene also is present in much higher concentrations in COE than arsenic; therefore, any leaking coke oven gas contains benzene and at much higher concentrations than arsenic. The EPA did not evaluate arsenic (or any other metal HAP) as part of the information requests related to fenceline monitoring. Instead, fenceline monitoring was performed at these sites to evaluate VOC/HAP emissions from fugitive sources. Although we recognize that arsenic is emitted from these facilities, the arsenic emissions are typically hot and emitted from ducted sources such as stacks at much higher elevations than the ground level of the fenceline. Therefore, we do not expect arsenic to be detected at the fenceline. The emissions from elevated, ducted sources regulated under subpart CCCCC that do not directly impact the fenceline measurements are measured at the source through periodic compliance testing required to demonstrate compliance with the MACT standards.
Lastly, hydrogen sulfide is not currently a listed HAP under CAA section 112, and so could not be considered in this rulemaking unless the EPA determined that it was a surrogate for one or more HAP emitted as fugitives from the category. We have not made such a determination.
A commenter contended the EPA does not specify when fenceline monitoring data submitted via CEDRI will be made available to the public. The commenter said that public access to fenceline data will allow regulators to detect non-compliance earlier, and that communities would be simultaneously informed of dangerous, higher concentrations of chromium (and for lead, if the EPA includes lead in the
Regarding the public availability of data and monitoring locations, we are finalizing, as proposed, the requirement that the exact location of each sampling location (latitude and longitude) as well as the individual sampling results (both original results and corrected results if a monitoring location result is modified as a result of an SSMP) are included in the quarterly report at 40 CFR 63.311(j)(3) and (5). These quarterly fenceline reports will be submitted to CEDRI and subsequently be available to the public via the Web Factor Information Retrieval System (WebFIRE) (
To search for a fenceline monitoring report required by this rule, begin at the WebFIRE home page,
We received a few comments on the proposed lowered leak limits for doors, lids, and offtakes with comments both in favor of the proposed requirement and comments that were opposed to the requirements or requested significant changes.
Commenters contended that across the cokemaking industry, leak control for doors, lids, and offtakes is achieved through operational and maintenance work practices, not through add-on pollution controls or other equipment; and the current leak control methods existed and were considered during development of the original MACT standards [for subpart L, in 1993]. The EPA's use of new leak rate data for coke battery facilities is not based on any previously unidentified leak control work practices, operational procedures, process changes, add-on controls, or pollution prevention alternatives. Leak rate data, like other forms of emissions data, are simply information about a practice, process, or control technology. The commenters stated the EPA's approach improperly equates data showing overcompliance with existing standards as “developments” in leak control practices and processes. Nothing in the language of CAA section 112(d)(6) gives the EPA authority to rachet-down existing MACT floor limits based solely on data showing overcompliance with those existing limits. The commenter contended there is no explanation for why the EPA selected a 3 million tpy threshold versus some other level of coke production capacity. It is counterintuitive to presume that higher coke production capacity correlates to lower leak rates. The existing subpart L door leak standards are not based on coke production capacity; and one would expect that higher production facilities have a larger number of ovens in operation, with more cycles of charges and pushes,
The commenter also stated that since promulgation in 1993, the subpart L door leak limits have been based on the height of the door (
The commenter contended the EPA seemingly acknowledges this by proposing different leak limits for “tall” and “not tall” doors for facilities with greater than 3 million tpy production capacity. However, the EPA offers no explanation why size of the door matters for leak limits at higher production facilities but size does not matter for lower production facilities.
The lower leak rate standard for larger capacity facilities reflects the lower leak rates shown in the recent EPA Method 303 data for those operations. The commenter correctly notes that oven leak rates are not functionally related to the number of ovens at a facility; rather, leak rates depend on whether each oven is well-sealed or not. As noted above, the primary determinant of leak rates is the effectiveness of work practices to detect and minimize leaks. There is not an apparent reason for why larger capacity facilities are attaining lower leak rates other than that they are more effectively employing work practices to control leaks. Industry commenters have not suggested an alternative explanation. In this situation, the distinction based on facility size (as allowed by CAA section 112(d)(1)) reflects more effective work practices at the larger facilities. There may be, for instance, cost-related reasons why smaller capacity facilities have not employed the same work practices as larger facilities. It is reasonable to infer that a larger capacity facility may be able to invest more resources in leak control practices. Lacking a firm basis for concluding that smaller facilities can reasonably achieve the same performance as larger facilities, the EPA is finalizing the capacity-based distinction in leak rate limits supported by current measurement data.
That leak rates are primarily determined by work practices, and that work practices are not restricted to facility capacity, if anything, suggests that the lower leak rates achieved at larger capacity facilities should be achievable at smaller facilities as well. Notwithstanding such a possible inference, the EPA is setting leak rate limits at levels demonstrated to be achievable by the available data.
The EPA selected a 3 million tpy production of coke production capacity because the production of the facility in this category (nearly 5 million tpy capacity) is more than twice the capacity of the next highest facility (<2 million tons coke capacity). This is a clear break point in size between larger and smaller capacity facilities, and that break point aligns with the data showing lower leak rates at the larger facility.
Regarding the commenter's request to use door height for setting door limits for lower production capacity facilities, the EPA agrees with the commenter and is finalizing allowable door limits for both “tall” and “not tall” batteries, as described in section IV.B.4.b. of this preamble and in the
We received 2 comments on requiring both zero leaks from HNR oven doors and concurrent oven and common tunnel pressure monitoring. Both commenters were not in favor of the proposed amendments to require pressure monitoring in ovens. No comments in support were received.
The commenter continued that installing and maintaining pressure monitors in each oven would be exorbitantly expensive, challenging, and unreliable. The commenter estimated costs of $3 to 4 million for every 100 ovens subject to this requirement. In addition, pressure monitors located in the ovens must be manually cleaned out by maintenance personnel 2 to 3 times per week, exposing personnel to excessive heat, which is an unnecessary safety risk. The commenter stated that SunCoke's heat recovery facilities already monitor negative pressure in the common tunnel electronically on a continuous basis and have one pressure transmitter for every seven (7) ovens in the battery on average. Monitoring for negative pressure in the common tunnel, in conjunction with monitoring for coke oven leaks throughout all stages of coking as previously described, accurately captures any time that an oven is experiencing positive pressure and allows personnel to take action in a timely and safe manner when necessary. Therefore, the commenter states that the EPA should not include these proposed changes to pressure monitoring in 40 CFR 63.303(a)(i) in the final rule.
Another commenter also stated that the EPA proposed rule includes unnecessary and redundant instrumentation to monitor HNR oven operational pressure continuously.
In regard to the proposed requirement to require zero leaks from HNR oven doors, as determined by EPA Method 303A, a commenter notes that SunCoke's work practices are already consistent with 40 CFR 63.303(c)(2) in that SunCoke monitors the ovens for the entirety of the coking cycle and responds to any observed door leaks to make adjustments to the ovens by reviewing electronic data and physically walking the coke oven batteries. Any door leaks due to positive pressure are corrected by adjusting oven uptakes, dampers, and/or sole flues, and are then recorded, and reported as required under 40 CFR 63.303(c)(2).
Because of the commenter's statements that due to another part of the COB rule, 40 CFR 63.303(c)(2), HNR facilities are already required to respond to oven leaks, and that all HNR facilities already “monitor the ovens for the entirety of the coking cycle and respond to any observed door leaks to make adjustments to the ovens by reviewing electronic data and physically walking the coke oven batteries,” we are promulgating the requirement for zero leaks from oven doors, with daily monitoring using EPA Method 303A, so that the current SunCoke practice to observe oven doors to maintain zero leaks is codified in the rule.
Therefore, in the final rule, a HNR facility is required to demonstrate and maintain zero leaks from HNR oven doors, and measure pressure in either the ovens or common tunnels to demonstrate negative pressure, minimally during charging, coking, and pushing.
We received one comment on the revised emissions equation for emissions from leaking doors which suggested corrections to the equation.
The commenter continued that another issue is that the EPA's proposed change assumes that PLD
The commenter asserted the EPA should estimate PLD
The 2022 CAA section 114 test data submitted included only PLD from the bench,
The results of the analysis of CAA section 114 data submitted by Cleveland Cliffs' Burns Harbor and U.S. Steel's Clairton facilities are shown in table 5 of this section. Similar to the commenter, we combined the 1981 leak data with the 2022 leak data so as to have a more robust data set. We first determined the average ratio of PLD-bench-only to PLD-yard for both batteries from each facility, and from both coal and coke sides in the 1981 and 2022 data. These ratios were averaged together to produce a revised PLD bench-only/PLD yard ratio of 1.5 to use in the leak emissions equation. See table 6 of this section.
In order to determine the value for PLD-bench only when PLD yard is equal to zero, we plotted PLD yard by PLD bench-only, similar to the commenter's approach but using PLD bench-only instead of PLD bench-total. The intercept of the regression line with the y-axis is the value for PLD-bench-only when PLD yard is 0, at 0.7 percent (or a factor of 0.007). The correlation coefficient (r
The revised door leak equation using the revised ratio of PLD-bench-only to PLD yard of 1.5 and adding a third term in the equation to represent the case where PLD-yard is equal to zero is shown below:
See the
We received one comment on the proposed opacity limit for HNR B/W stacks that objected to the numerical value, the frequency of the proposed limit, and the coke NESHAP (COB) in which the limit was proposed. The comment is summarized below along with the EPA response.
The commenter also stated that it would not be appropriate to establish a daily [opacity] observation requirement at heat recovery facilities because the bypass stacks do not operate on a continuous basis. Because venting at SunCoke's heat recovery facilities can be brief and intermittent, imposing such a requirement any time the bypass vent stacks are in operation would result in greater environmental harm because it would extend the duration of venting to allow SunCoke sufficient time to dispatch certified personnel to the appropriate location in the plant to conduct readings per EPA Method 9. The commenter, therefore, urged the EPA to not include its proposed changes to 40 CFR 63.303(d)(3) in the final rule, and stated that including these changes would be unnecessary, arbitrary and capricious. Moreover, SunCoke notes that the EPA is attempting to regulate the same source—bypass/HNR B/W stacks—as part of two different source categories, subparts L and CCCCC. The commenter also stated that the EPA lacks authority to impose the proposed new opacity limit and the related requirements, arguing that the EPA had not shown these requirements are “necessary,” taking into account developments in practices, processes, and control technologies. See 42 U.S.C. 7412(d)(6) (requiring the EPA to “review, and revise as necessary (taking into account developments in practices, processes, and control technologies), emission standards promulgated under this section”); 88 FR 55883 (the EPA “did not identify any developments in practices, processes or control technologies”) (emphasis added).
Based on the comments received, we are finalizing a 20 percent opacity limit for HNR B/W stack, pursuant to a CAA section 112(d)(6) technology review of the PQBS NESHAP, to be measured weekly when a bypass event occurs for more than one continuous hour to allow sufficient time to ascertain whether the bypass event will last long enough to test opacity with EPA Method 9 and, if so, to dispatch personnel qualified to perform EPA Method 9 to the B/W stack. When there is at least one bypass event during any week that last for at least one hour, the weekly opacity testing requirement applies. This condition is important for the four HNR facilities that do not have continuous bypass. The one HNR facility with continuous bypass will be able to test anytime during each week. We agree with the commenter that the revised opacity requirements for HNR B/W stacks should be included as part of the technology review pursuant to CAA section 112(d)(6) under 40 CFR part 63, subpart CCCCC.
The leak limits being finalized for doors, lids, and offtakes reflect changes from the proposed rule based on information obtained from a number of ByP facilities on the variability of leaks on daily rolling 30-day average basis. Using the available data, we compared the maximum 30-day rolling averages with the maximum annual averages and developed adjustment factors to account for variability. Then, we multiplied the adjustment factors by the maximum annual average for each leak type. We are promulgating these revised leak limits (shown in table 4 of this preamble). Available data demonstrate that these limits reflect current performance of facilities and are, therefore, achievable. The current performance reflects improvements in work practices, specifically practices designed to enhance prevention, detection, and remediation of leaks and, therefore, constitute a “development” for purposes of CAA section 112(d)(6).
We revised the modeling procedures to incorporate irregular-shaped facility properties after considering public comments. This resulted in a change in the action level from 3
We are not requiring pressure monitoring in both ovens and common tunnels in the final rule for COB because we did not receive any comments in support of requiring both and we received information on the cost and other problems with installing and maintaining oven monitors. We received two comments describing the redundance of requiring both as well as description of the safety problems with using pressure monitors within ovens. In the final rule, we are requiring both zero leaks from HNR oven doors and pressure monitoring in either ovens or common tunnels. From the comments received, we learned that HNR facilities already monitor ovens to ensure there are no leaks, so the final rule codifies this practice. The compliance date for zero leaking oven doors and pressure monitoring at HNR facilities is July 7, 2025.
We revised the proposed equation to estimate COE emissions from leaking doors based on VE test data received from two facilities that was obtained by the EPA in 2022 and combined these data with VE test results from 1981, which was when the equation first was developed. In addition, we received a comment that the equation did not account for the case where no VE from
We are finalizing a 20 percent opacity limit for HNR B/W stacks under the PQBS NESHAP because this limit is currently required and achieved at the one HNR facility with continuous bypass and because the opacity limit in the rule will ensure continued compliance for this source as well as the other HNR B/W sources with intermittent bypass. We are requiring weekly testing for HNR waste heat stacks, which operate continuously. For HNR bypass stacks, which operate intermittently, testing is required weekly if and when bypass occurs longer than one hour so as to enable testing using the procedures in EPA Method 9 and so as to not prolong emitting bypass exhaust solely for the purpose of testing. The compliance date for opacity limit on HNR B/W stacks is July 7, 2025.
Consistent with the
• Pushing: AG, HCN, Hg, PAHs;
• ByP battery combustion: AG, HCN, Hg, nonmercury HAP metals;
• HNR HRSG main stack: AG, Hg, nonmercury HAP metals, PAHs; and
• HNR HRSG bypass/waste heat stacks: AG, Hg, formaldehyde, nonmercury HAP metals, and PAHs.
Based on the data we had at proposal, we expected all sources could meet the 17
We proposed BTF limits for Hg and non-Hg particulate matter (PM) HAP metals at HNR facilities without HRSG based the addition of baghouses and activated carbon injection (ACI). More details are provided in the August 16, 2023, proposed rule preamble.
We are finalizing 17 new MACT floor-based standards
In addition to the 17 MACT floor limits described above, during the EPA's review of this Coke Ovens RTR final rule, we realized that we did not propose standards for eight additional HAP and process combinations. As a result, the EPA also is finalizing a MACT work practice standard based on “good combustion practices” in battery waste heat flues to address the organic HAP emissions of D/F, PAH, and VOHAP from battery stacks. In addition, we are finalizing surrogate standards for five additional HAP and process combinations for which many, but not all, test runs were below the detection limits (BDL), as follows: D/F, formaldehyde, and VOHAP from pushing; formaldehyde from HNR main stacks; and VOHAP from HNR B/W stacks.
The additional eight unregulated HAP and process described in this section were documented in the memorandum
Although the test data for the 17 HAP
To address this issue, we are promulgating work practice standards pursuant to CAA section 112(h) for battery stacks based on ensuring good combustion in battery waste heat flues for D/F, PAH, and VOHAP emissions from battery stacks since it is not economically and technically feasible to
The three additional emission standards and one work practice standard apply as follows: (1) the final limits for PAH for pushing serve as a surrogate for all other organic HAP for pushing, including D/F, VOHAP, and formaldehyde (all had greater than 55 percent of test runs BDL); (2) the final limits for PAH from HNR HRSG main stacks serve as a surrogate for all organic HAP from this source, including formaldehyde, for which greater than 25 percent of test runs were BDL and from very limited data (only one test report from one facility); (3) the final limits for formaldehyde from HNR HRSG B/W stacks serve as a surrogate for VOHAP from B/W stacks (for which greater than 55 percent of test runs were BDL); and (4) a work practice standard of “good combustion practices” during ByP waste heat combustion in battery flues to minimize organic HAP emissions from battery stacks, including PAH, D/F and VOHAP.
The good combustion work practice standards require owners or operators to identify and implement a set of site-specific good combustion work practices for each battery. These good combustion work practices should correspond to the facility's standard operating procedures for maintaining the proper and efficient combustion within battery waste heat flues. Good combustion work practices include, but are not limited to, the following:
• Proper operating conditions for each battery (
• Routine inspection and preventative maintenance and corresponding schedules of each battery.
• Performance analyses of each battery.
• Maintaining applicable operator logs.
• Maintaining applicable records to document compliance with each element.
The work practice standards to minimize organic HAP emissions from battery stacks are being finalized under CAA section 112(h) because the EPA has determined that it is not feasible to prescribe or enforce an emissions standard. Sections 112(h)(1) and (h)(2)(B) of the CAA provide the EPA with the discretion to adopt a work practice standard rather than a numeric standard when “the application of measurement methodology to a particular class of sources is not practicable due to technological and economic limitations.” The “application of measurement methodologies” (described in CAA section 112(h)(2)(B)) means not only conducting a measurement, but also that a measurement has some reasonable relation to what the source is emitting (
With regard to surrogacy limits, we conclude that PAHs are a good surrogate for the other organic HAP (including D/F, VOHAP and formaldehyde) for the pushing operation because the relative amount of emissions of the other organic HAP due to the high temperature thermal distillation process in coke ovens which are expected to be emitted at a similar degree as PAHs. Regarding the HNR HRSG main stacks, PAHs are a good surrogate for formaldehyde and other organic HAP because the afterburners that facilities use to combust any remaining organic HAP in the oven exhaust are expected to control these organic HAP to similar levels as PAH. Likewise, formaldehyde is a good surrogate for VOHAP for HNR B/W stacks for the same reason (
We also conclude that the additional work practice standard and surrogacy determinations will not result in any new control costs or compliance testing costs.
The 17 MACT floor emissions limits,
Based on consideration of public comments and our revised cost estimates, the EPA is not promulgating the BTF standards for HNR facilities without HRSG. Instead, these units will need to comply with the same MACT floor standards that the EPA is promulgating for HNR HRSG bypass stacks for facilities with HRSG.
We received many comments on the proposed MACT and BTF standards with comments in favor of the proposed limits, comments requesting more stringent limits, and comments that were opposed to the proposed requirements. The key comments on the proposed amendments developed pursuant to CAA sections 112(d)(2) and (3) are summarized in this section along with the EPA's responses to the comments. Other comments received on these proposed amendments are summarized along with the EPA's responses in the
• Further reductions of these pollutants are not necessary due to very low risk of the source category;
• Controlling these pollutants has not been demonstrated for sources like ByP battery stacks;
• The cost of adding controls would be exorbitant; and
• The new standards would not be cost effective due to the extreme cost of controls and the minimal reductions in these pollutants that would be achieved.
The commenter urged the EPA to reconsider its long-held interpretation that costs are not considered in setting the MACT floor. The commenter argued that interpretation is not reasonable in the context of a setting
The commenter also asserted that the EPA erred in calculating MACT floors for existing sources based on actual emissions performance rather than on enforceable limitations to which existing sources are subject. The commenter argues this contravenes the plain language of CAA section 112(d)(3), which requires the MACT floor to be based on the “average emission limitation achieved “by the best performing sources.”
The language and structure of CAA section 112 further underscores the independent nature of these two provisions. While the EPA is only required to undertake the risk review once (8 years after promulgation of the original MACT standards), it is required to undertake the technology review multiple times (every 8 years after promulgation of the original MACT standard). That Congress charged the EPA to ensure an ample margin of safety through the risk review, yet still required the technology review to be conducted on a periodic basis, demonstrates that Congress anticipated that the EPA would strengthen standards based on technological developments even after it had concluded that the revision was not warranted under CAA section 112(f) . This provision's CAA section 112's overarching charge to the EPA to “require the maximum degree of reduction in emissions of the hazardous air pollutants subject to this section (including a prohibition on such emissions)” further demonstrates that Congress sought to minimize the emission of hazardous air pollution wherever feasible independent of a finding of risk.
When the EPA sets MACT standards pursuant to the
The EPA also disagrees that the CAA allows the EPA to take costs into consideration in determining MACT floors. The D.C. Circuit has ruled that costs are not to be considered when setting MACT floor standards. In
Requiring the consideration of costs in setting the MACT floor would conflict with the plain language of CAA section 112(d)(3). Section 112(d)(3) of the CAA provides that the emission standards developed under this section “
We note in this context that for the Coke PQBS source category, based on the data submitted to the EPA by the industry, all facilities should be able to meet the MACT floor limits developed for the previously unregulated HAP and unregulated sources of HAP without the installation of additional controls. Commenters who raised claims of exorbitant costs to meet the new MACT floors did not provide any additional data contradicting the EPA's findings; thus, the EPA does not find any support for these claims.
Regarding the commenter's claim that the MACT floors must be based on emissions legally allowed rather than actual performance, the D.C. Circuit has spoken to this issue several times, including in
The D.C. Circuit in
In defining the parameters for the MACT floor, Congress recognized that standards will necessarily be based on data that does not account for all operating scenarios. Section 112(d)(3)(A) of the CAA provides that MACT standards shall reflect the average of the best performing sources “for which the Administrator has emissions information.” For categories comprised of five or fewer sources, standards shall reflect the best performing sources “for which the Administrator has or could reasonably obtain emissions information.”
The MACT standards being promulgated in this rule reflect available information, including additional information brought forward by industry during the comment period. The EPA sent 2 CAA section 114 testing requests to coke oven companies in 2016 and 2022 to collect test data to be used in the MACT determinations. The data used for the proposed MACT limits were all the data that were available to the EPA at that time. The EPA used these data to calculate the proposed limits. However, as explained in responses to previous comments in this section, the EPA revised some of these limits after incorporating additional data received after publication of the proposed rule. These changes are described in the
As noted above, it is not uncommon for MACT standards to be based on data sets that are comprised of test results and therefore do not represent all known operating scenarios. Some data sets are more limited than others, and the EPA has explained its approach to the more limited data sets in memoranda
One commenter asserted that the limited amount of test data does not accurately represent emissions because the data do not account for normal variability in operations, variability of coal blends and suppliers, and seasonal effects. Without additional test data, the commenter expects the proposed limits will be regularly exceeded, forcing facilities to install expensive controls or curtail operations to meet the limits.
The commenter asserted it is critical that any standards be established using complete data and UPL methodologies that adequately account for variability in operating conditions (
The commenter contended that a single test covering less than a handful of operating hours does not represent normal emissions from a unit at all times over the range of normal operating conditions during a typical year. Actual emissions will vary from time to time not only due to normal variations in process operations (differing coking times, variability in composition of feed materials and fuels, process operating conditions,
One commenter noted that in section 2.1.2 of the
The commenter noted that in section 2.3.2 of the
The commenter asserted the lack of demonstrated technical feasibility and the extremely high cost of add-on controls in the
Another commenter asserted the EPA incorrectly established the proposed HNR HRSG main stack emission limits using only a limited subset of the available data, thus, the data set is incomplete and not representative of HNR operating conditions. The commenter described the test data from the 2016 ICR and the 2022 ICR, on which the MACT floor calculations are based, as “very limited.” The commenter contended a much larger dataset that more accurately represents trial-to-trial and plant-to-plant variations is available from compliance tests conducted on these sources in prior years, yet the EPA provides no explanation for why it excluded this larger body of stack test data from its MACT floor calculations.
The commenter asserted the EPA's use of the limited data set and its UPL approach for setting MACT limits did not reasonably account for variability. The commenter contended there are too few data points for a statistically valid analysis and limit. The UPL calculation relies upon estimating the true average and true variance. While the estimation of the average can be confidently done with a small number of samples, the estimation of the variance requires a substantially larger number of samples and in particular samples that cover the range of varying factors.
The commenter asserted the EPA's decision to base the proposed rule requirements on limited data is arbitrary and capricious, and that the EPA gave no explanation for its decision to ignore relevant information provided by the types of facilities to which the proposed limits would apply. The commenter cited language from a court case holding that agencies “must
The commenter asserted the EPA must recalculate the HNR HRSG main stack limits using all available stack test data from 2006 through 2022 from SunCoke HNR HRSG main stacks at Haverhill, Middletown, and Granite City, and the Cokenergy HRSG main stack at Indiana Harbor. The commenter argued the 45-day comment period did not provide sufficient time for them to fully evaluate and propose more appropriate and accurate revised limits. Nonetheless, the commenter noted their preliminary estimates (correcting for the arbitrarily confined dataset used) demonstrate that the UPL calculations used must be revised significantly.
The commenter noted the EPA expects their facilities (with the exception of the Jewell coke plant) to meet the proposed bypass vent stack limits with no additional controls. However, the commenter asserted, this expectation may be wrong as the emission limits are based on a very limited data set. The commenter contended additional controls may be required to meet the proposed bypass vent limits at some or all of their heat recovery facilities. (The commenter discussed controls needed for SunCoke's Jewell facility separately in their comment letter). The commenter explained that waste gases exiting the bypass vent stacks are typically in the 1300 °F to 2000 °F temperature range. To install any kind of additional pollution control equipment on the bypass vent stacks would first require cooling the high temperature waste gases significantly, using HRSGs or similar equipment, to a level that is appropriate for the specific control equipment. The current layout of their plants and the limited space available in and around the bypass vent stacks make it extremely challenging to design and install additional HRSGs, route additional ductwork, and install any additional control equipment for the bypass vent stacks. The commenter asserted, even if this could be engineered, the cost effectiveness ($/ton removed) would be extremely high considering the bypass vent stacks are used and open for venting only a fraction of the time on an annual basis. Even then, any time that bypass venting was required for any reason, the source would not be able to meet the proposed limits because it is not technically feasible to install controls directly on waste heat stacks.
Other commenters stated the proposed amendments to 40 CFR part 63 subpart CCCCC and subpart L are based on limited data that were not peer-reviewed data and do not consider operational variations. Additional commenters stated any amendments made to the existing regulations should be consistent with the CAA and based on sound science.
The EPA disagrees with the commenter's statement that UPL calculations do not incorporate variability into the UPL-based limit. The use of the UPL to account for variability was upheld in
In addition, the EPA disagrees with the commenter that the standards should be revised to use a larger pool of test data to account for variability in operating conditions. It is incorrect to assume that including more data will cause the average or UPL to reflect more variability. Depending on the additional data, the increase in the size of the dataset may outweigh any additional variability and lower the UPL limit. That the UPL represents the average emission performance is described in the second point in the previous paragraph citing the
Additionally, the EPA handled the limited datasets used to set the MACT limits (pushing new source limits: Hg, AG, HCN, and PAH and battery stack new source limits: Hg, PM, AG, HCN) as per the procedures in the memorandum
The EPA did not have data for each existing pushing technology as shown in table 8, which lists the existing NESHAP PM pushing limits by technology, and as compared to table 9, which shows the data collected as part of the CAA section 114 request for this rulemaking, with pushing technology identified. Therefore, separate MACT limits were not developed for each pushing technology from the data submitted to the EPA. In addition, any MACT limits that might be set for subcategories would have less variability than the data in the pooled MACT limit for all pushing technologies.
For the proposal, the EPA evaluated potential control technologies for pushing sources as documented in the
The EPA collected test data from the 2016 CAA section 114 test requests for HNR HRSG main stacks. The EPA conducted a second CAA section 114 testing request in 2022 for additional stack testing data from HNR HRSG main stacks. The EPA used the available data to calculate the MACT limits, as described in the
SunCoke provided the EPA with previous stack test data from 2006-2022 with their 2016 CAA section 114 submission. After the August 2023 proposal, the EPA reviewed the previous test reports submitted that were within five years prior to 2016 and that matched the requirements for testing in the CAA section 114 requests to add to the MACT data pool. We determined that there were four test reports listed in table 10 of this section, three for HNR HRSG main stacks and one for HNR B/W stacks, that were applicable to sources and pollutants in the CAA section 114 requests and, therefore, we have incorporated these data into a revised MACT floor calculation for the final rule.
We received test data from Cokenergy, Inc., for HNR HRSG main stacks at the SunCoke facility in Indiana Harbor in 2022, but these data were received too late to incorporate into the proposed rule. These data also are included in the MACT limits for HNR HRSG main stacks for the final rule.
In addition, we received test data from EES Coke on April 24, 2024, that included HAP test data from a February 21, 2024, emission test for pushing and battery stacks. We determined that of the HAP tested, the data for AG, HCN, and PAH for pushing and AG, HCN, and Hg from battery stacks were valid. Therefore, these data also were incorporated into the MACT limits.
The additional test data added to the final MACT data pool that were not reflected in the proposed MACT limits are shown in table 10. The results of these additions to the MACT data pool are shown in table 7 and documented in the
For the August 2023 proposal, the EPA estimated the costs for additional controls that would be used at the HNR facility without a HRSG to meet the proposed BTF limits for Hg and PM at HNR B/W stacks at this facility. The EPA has re-evaluated the proposed costs for the BTF limits based on comments received and revised the cost estimates for the HNR facility without HRSG. The revised costs are much higher than the costs at proposal ($7.5M capital and $4.6M annual costs ($2022) v. revised costs of capital $340M capital and $56M annual costs ($2023)). We also received comments that it would be infeasible to construct controls at this facility given the configuration of the facility between the bordering roads, rivers, and train tracks on all sides. Therefore, due to the physical constraints and high costs, the EPA is not finalizing the BTF standards for Hg and PM for HNR B/W stacks at facilities with no HRSG. As such, revised MACT standards for HNR B/W stacks were determined by incorporating the previous SunCoke Hg and PM test data described above and the data for the HNR facility without HRSG (previously used in the BTF analysis). The revised MACT limits for final rule apply to all HNR B/W stacks,
The EPA agrees that the MACT standards should be consistent with the CAA and based on “sound science” as the commenter describes. The EPA utilized data conducted and submitted in compliance with two CAA section 114 requests, in 2016 and 2022, and additional valid data received after the proposed rule was published. The EPA developed the standards according to well-established CAA section 112(d)(2) and (3) procedures, established EPA methods and policy, and case law and incorporated operational variability by applying a UPL to the MACT floors. See
In regard to the comment that the proposed amendments to PQBS and COB NESHAP are based on “limited data” that were not peer-reviewed, the EPA notes that it would be out of the ordinary to subject data used to support a CAA regulation to a scientific peer review process. The methods used to collect data are peer reviewed, and the EPA engaged in a dialogue with the coke oven plants regarding the data produced in response to a CAA section 114 request to ensure that data was representative. Finally, the notice and comment process to promulgate a rule is an opportunity for interested parties to raise issues regarding the data relied upon by the EPA. These measures typically relied upon by the EPA to ensure the quality of data were followed in this rule process.
Finally, the requirement for establishing the minimum stringency level under CAA section 112(d)(3) for categories or subcategories with fewer than 30 sources is that the EPA base those standards on “the average emission limitation achieved by the best performing 5 sources (for which the Administrator has or could reasonably obtain emissions information).” These final standards meet that requirement.
The commenter said the EPA's costs are underestimated for other reasons as well, including the following:
• The EPA miscalculated the emissions reductions of the proposed BTF limits at their Jewell facility because they wrongly assumed the feasible reductions of a baghouse and ACI system on a long-term basis. According to the commenter, 99 percent removal for the baghouse is a more realistic assumption of long-term removal than the 99.9 percent removal assumed by the EPA. Similarly, for Hg, a baghouse with ACI combination can only reasonably provide 80 percent Hg removal on a long-term basis versus the 90 percent reduction assumed by the EPA.
• The EPA's estimates did not include cooling before subjecting the 1,600 °F exhaust from the HNR B/W stacks to emissions controls, as would be necessary for the baghouse to function. The oven exhaust must be cooled from 1,600 °F or more to a maximum of 400 °F for high temperature bag material to function. And an air quench, as opposed to a water quench, would be required because the enormous water volumes otherwise required would far exceed the limitations of Dismal Creek, the source of plant cooling water. The air quench would result in a constant steam cloud within the valley. The commenter contended these two factors alone make a baghouse and an ACI system technically infeasible for this site.
• The ductwork costs assume only a nominal length of unlined, galvanized steel duct between the battery stacks and the air emission controls. No provision for refractory lining, and ductwork foundations, structural support, access platforms, and underground routing of the duct were considered.
• The assumed height of the exhaust stack was too low. Given the valley location of the Jewell facility, an exhaust stack of significant height should have been considered.
• A shaker baghouse—notably the lowest capital cost baghouse type—was assumed. Shaker baghouses are old technology no longer used in industry because of high maintenance requirements, challenges with operation, and degradation of removal efficiency over time. A compartmentalized, pulse jet baghouse is the industry standard for this application.
• The EPA failed to consider the characteristics of the exhaust gases and the requisite materials of construction.
• The EPA incorrectly assumed the volume of flue gas that would need to be treated based on arbitrary data from a single stack at a different plant.
• The EPA failed to consider the unique retrofit requirements that would be necessary given the age, configuration, layout, and underground utilities existing at the Jewell facility.
• The EPA significantly underestimated the amount of electricity usage and hazardous waste that would be generated.
• The EPA used an incorrect algorithm to calculate the total capital investment for ACI (Sargent & Lundy 2011).
• The EPA used an incorrect methodology to calculate the ACI rates. Based on the methodology included in a later study by the same authors (Sargent & Lundy 2017), the rate should be 699 lbs/hr rather than 50 lbs/hr, as the EPA assumed.
• The EPA did not sufficiently consider the infrastructure upgrades that would be needed to install controls to meet BTF limits at their Jewell facility.
• The EPA wrongly calculated the increased energy costs to meet the BTF limits for their Jewell facility. The commenter noted they have not been able to locate the EPA's energy analysis.
• The EPA underestimated the tons of hazardous dust disposal at 761 tpy.
The commenter contended that their Jewell facility, which is in a river valley with rivers, a state road, railroad tracks, and extremely steep gradients on two sides, does not have sufficient space to install the size of baghouse(s) needed to control the exhaust from the COB. The commenter contended installing the infrastructure could require surfaces to be levelled and forested areas to be cleared. These electrical upgrades would likely impact wetlands, visual resources, soils, and/or vegetation and wildlife species in the affected areas, which the EPA does not appear to have considered.
• The EPA revised the BTF cost estimates developed by the EPA for proposal using some, but not all, of SunCoke's suggestions submitted with their comments, such that the EPA's cost and cost effectiveness (CE) estimates now include the following SunCoke costs/procedures that the EPA agrees are better estimates, as described in the
• The EPA did not use SunCoke's values/estimates/procedures for: ACI 2017 cost equation; estimating ductwork costs; 5 percent interest rate; and $44.25 labor rate. Instead, we used the EPA's previous method of estimating ACI control costs from 1996 proposed hazardous waste incineration NESHAP
The result of revising the costs components are as follows: estimated capital costs are $340M, estimated annual costs are $56M, with cost-effectiveness of $14M/ton non-Hg metals and $51,000/lb Hg. Based on these cost considerations along with concerns raised by the commenter above regarding infeasibility to install these controls, the EPA has decided to not promulgate the BTF standards. Therefore, the MACT floor emission limits will apply to all HNR waste heat stacks, including the SunCoke Vansant, Virginia waste heat stacks, regardless of the presence of HRSGs. See the
The EPA agrees that the calculation for the increased electricity use was not explicitly documented in the information used for proposal. The values can be calculated using data in the attachment to the
(1) Using cell B129 value of electricity 514,816 $/yr;
(2) Divide by cell D112 electricity price 0.0671 $/kWh; and
(3) Multiply by 2 for the two APCD configurations to obtain a total of 15.3 million kilowatt-hours of increased electricity use [Note, the preamble to the proposed rule erroneously cited 15.1 million kilowatt-hour, due to rounding differences].
As mandated by the
We proposed the removal of exemptions for periods of startup, shutdown, and malfunction (SSM) consistent with a 2008 court decision,
Only minor changes from those proposed were made for SSM for the NESHAP for PQBS and COB source categories.
We received a few comments on SSM, with some in favor of the removal and some that were not. The key comments on SSM are summarized in this section along with the EPA's responses to the comments. Other comments received on SSM are summarized along with the EPA's responses in the
In regard to the commenter's statement that “coke facilities should have an option to meet work practice requirements for malfunction periods or meet the requirements applicable to normal operating periods,” the EPA notes that facilities always have the option of complying with the applicable limits and using work practices, even during a malfunction. As stated in the proposal preamble [88 FR 55890]: ” the standards that apply during normal operation apply during periods of malfunction.” As the EPA has consistently explained, in the event that a source fails to comply with the applicable CAA section 112 standards, the EPA would determine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during the violative period, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify excess emissions. Additionally, the EPA will continue to evaluate violations on a case-by-case basis and determine whether an enforcement action is appropriate.” The D.C. Circuit upheld the EPA's general approach to malfunctions in
With regard to commenters statements addressing the removal of SSM plan requirements, note that affected units are subject to emission standards at all times. The applicability of a standard during any SSM event will ensure that sources have ample incentive to plan for and achieve compliance and thus the SSM plan requirements are no longer necessary.
Periods of startup, normal operations, and shutdown are all predictable and routine aspects of a source's operations. Malfunctions, in contrast, are neither predictable nor routine. Instead, they are by definition, sudden infrequent and not reasonably preventable failures of emissions control, process, or monitoring equipment (40 CFR 63.2) (definition of malfunction). Nor are emissions during a malfunction able to be reliably measured with EPA methods which specify that these methods are only to be used during normal operations. The EPA interprets CAA section 112 as not requiring emissions that occur during periods of malfunction to be factored into development of CAA section 112 standards (either numerical or as work practices)and this reading has been upheld as reasonable in
We are finalizing the removal of exemptions for periods of SSM consistent with a 2008 court decision,
In its 2008 decision in
With the issuance of the mandate in
The EPA has attempted to ensure that the provisions we are promulgating to eliminate are inappropriate, unnecessary, or redundant in the absence of the SSM exemption. In promulgating the standards in this rule, the EPA has taken into account SS periods and, for the reasons explained as follows, has not promulgated alternate standards for those periods: The coke oven industry has not identified (and there are no data indicating) any specific problems with removing the SSM provisions due to the nature of the coke process to operate continuously. If an oven is shut down (cold), it often has to be significantly repaired before it can be restored to operational status before starting back up, which is the reason why coke ovens instead are put in (hot) idle mode when not operating.
For all the above these reasons, we are finalizing that the standards for PQBS NESHAP and the COB NESHAP apply at all times including startup, shut down, and malfunction.
We did not propose any amendments that were expected to force facilities to close, as described in the economic analysis performed for the proposed rule. We also did not propose to list CBRP facilities under CAA section 112.
We did not finalize any amendments that were expected to force facilities to close, as described in the economic analysis for the final rule. See section V.D.
In the final rules as in the proposal, we are not listing CBRP facilities under CAA section 112 but we intend to list CBRP operations as a source category under CAA section 112(c) in a separate, future regulatory action. We intend to provide the EPA's rationale for such listing in the future action along with details of the EPA's regulatory activities in regard to the CBRP facility. We will perform data gathering to support the listing using a CAA section 114 request that we intend to distribute by the end of the 2024 calendar year and that will request information related to CAA section 112 requirements.
The key comments on the Other Issues are summarized in this section along with the EPA's responses to the comments. Other comments received on these issues are summarized along with the EPA's responses in the
We received a few comments on the potential for facility closures as a result of the proposed amendments. These comments are summarized below along with the EPA responses.
One commenter stated that there are only two remaining blast furnace steelmakers in the U.S., namely Cleveland-Cliffs, Inc., and U.S. Steel, both of whom rely heavily on the coke industry to provide them millions of tons of coke annually. The commenter asserted that should SunCoke be forced to curtail or cease coke production to meet the new limits as required by the EPA rulemaking, SunCoke may be unable to meet its contractual obligations and be unable to supply steelmakers with the quantities of coke necessary to fuel the domestic steel industry.
The commenter emphasized that a strong domestic steel industry is vital to national and economic security, the U.S. clean energy transition and decarbonization strategy, critical infrastructure, and the competitiveness of many domestic manufacturing industries. The domestic steel industry is the cleanest and most energy-efficient in the world; steel production in the
Other commenters contended our national security, in both the economic and military senses, depends on being able to convert iron ore into a usable product for our nation. Our manufacturing, transportation, construction, energy, and military all require steel. The U.S. steel industry cannot be 100 percent recycled steel as it needs new iron units for quality and quantity reasons. Coke batteries make coke, coke reduces iron oxide from in the ground to usable pig iron, and pig iron makes steel. It is fundamental to so much of the U.S. economy and we need U.S. Steel's coke batteries to remain operational and competitive.
Several commenters contended the U.S. Department of Commerce has recognized that the domestic steel industry is vital to assuring our national security and maintaining critical infrastructure. It is crucial that we continue to maintain the balance of environmental responsibility and economic opportunity for our country. We should not risk the future of our remaining manufacturing jobs and national security. The U.S. Steel facilities are very important to our region and country. Working together, we can accomplish three important goals for future generations: protect our region's jobs, preserve our environment in which we work and live, and preserve our ability to convert iron ore into steel for national economic and military security.
One commenter stated the proposed EPA rule threatens to make coke production uneconomical (through the cost of controls) and impractical (through compliance with the new standards that, as written, is a practical impossibility). If implemented, the proposed EPA rule will reduce coke reduction in the U.S. at a time when domestic steel production is more important than ever.
Another commenter stated the proposed amendments could be detrimental to the coke industry and reduce U.S. production, with potentially negative ramifications for the U.S. economy.
Another commenter stated over the past decade, numerous coke plants have been forced to close due to aging assets and increasing facility costs to meet existing environmental requirements. The EPA's proposed rule would only further this trend, by imposing unattainable emission limits, extensive compliance tests, and costly surveillance for all coke facilities. These new standards would cost coke plants millions of dollars in compliance and force many to shutter their doors due to the stringent and impractical demands.
As explained in the memorandum
As documented in the
All previous coke plant closures have been due to a combination of market reductions in demand for steel and, therefore, coke, and multiple noncompliance issues with their states for sources that were not Coke PQBS or COB mission sources but which required significant upgrades and cleanup costs.
There currently are three ByP companies producing blast furnace coke at five facilities (two facilities recently shut down). There was an acquisition by Cleveland Cliffs, Inc., of AK Steel and ArcelorMittal in 2020 that reduced the number of companies but not the number of facilities. There is one HNR company producing blast furnace coke at five facilities and two ByP companies producing foundry coke at two facilities (one is cold idle).
See sections V.C. and V.D. of this preamble for more information about the costs and economic impacts of these rules.
We received a few comments on listing CBRP facilities under CAA section 112. All except one were in favor of listing. These comments are summarized below along with the EPA response.
There are no amendments included in this final rule that were expected to force facilities to close. The BTF standards for HNR facilities without HRSG are not included in this final rule. We are extending the compliance date for the MACT standards by 6 months, for a total of 18 months after publication of the final rule in the
We did not list CBRP facilities under CAA section 112 in this final rule because we need to gather information to support both listing and regulation and intend to do that by end of 2024. Gathering additional data will enhance the quality of data used to develop the MACT standards, especially considering the complexity of the sources and the need for testing. We intend to list CBRP operations as a source category under CAA section 112(c)(5) in a separate, future regulatory action. We also intend to provide the EPA's rationale for such listing in this separate future action with details of the EPA's plan for future regulatory activities for the CBRP. We intend to send a CAA section 114 information request by end of 2024 to gather data for the future CAA section 112 regulation.
The proposed compliance date for the new MACT limits in the PQBS NESHAP was 1 year after publication of the final rule. The proposed compliance date for the two BTF emission limits for HNR B/W stack in the PQBS NESHAP was 3 years after publication of the final rule to allow time for the installation of ductwork and control devices. We estimated that the facility would need 3 years to complete this work and comply with the new PM limit due to the unique configuration of the facility. The proposed requirement for periodic compliance testing after the initial compliance demonstration with the required MACT standards was “at the end of each permit cycle.”
The proposed compliance date to begin fenceline monitoring under the COB NESHAP was 1 year after the publication date of the final rule; facilities must perform root cause analysis and apply corrective action requirements upon exceedance of an annual average concentration action level starting 3 years after the publication date of the final rule. The proposed compliance date under the COB NESHAP for the revisions to the limits for allowable leaks from doors, lids, and offtakes was 1 year after publication of the final rule.
We proposed the date for complying with the proposed SSM changes to be no later than the effective date of the final rule with the exception of recordkeeping provisions. For recordkeeping under the SSM, we proposed that facilities must comply with this requirement 180 days after the effective date of the final rule. Recordkeeping provisions associated with malfunction events would be effective no later than 180 days after the effective date of the final rule. The EPA proposed to require additional information for recordkeeping of malfunction events, so the additional time was necessary to permit sources to read and understand the new requirements and adjust record keeping systems to comply. The proposed reporting provisions were in accordance with the reporting requirements during normal operations and the semi-annual report of excess emissions.
The proposed date for complying with the proposed electronic reporting submission requirements was 60 days after publication of the final rule for performance tests and 1 year after publication of the final rule or the date the template is made available on the CEDRI website for compliance reports.
We changed the required initial MACT compliance in the final rule to be 18 months after publication of the final rule for all MACT emissions limits in the final rule. For the periodic MACT compliance testing, we are promulgating that periodic testing be conducted “at
For SSM, the final promulgation compliance dates also are unchanged from proposal and are as follows: no later than the publication date of the final rule except for the recordkeeping provisions, which for startup and shutdown are 180 days after the effective date of the final rule and for malfunction events, the recordkeeping requirements are effective no later than 180 days after publication date of the final rule.
We received a number of comments on compliance deadlines and compliance methods. Some commenters wanted shorter time periods for the deadlines and some wanted longer time periods. In regard to methods, some commenters wanted to use methods not included in the rules and some commenters wanted methods in the rules removed. The key comments on compliance are summarized in this section along with the EPA's responses to the comments. Other comments received on compliance are summarized along with the EPA's responses in the
Based on consideration of comments and other relevant information, we are promulgating the same compliance dates as proposed for fenceline monitoring, revised leak limits, SSM, and ERT submissions. We conclude that the final compliance dates and timelines for these requirements are appropriate as described previously in this section of the preamble. However, we are promulgating that periodic testing for the MACT limits be conducted “at the beginning of each permit cycle or every 5 years, whichever is shorter,” to account for permit periods that can extend for many years beyond 5 years due to delays in permit reviews and to establish compliance at the beginning of the permit cycle because permit conditions may change from the previous permit cycle.
For the MACT standards, as described in responses in previous subsection of this preamble, we made some adjustments to the dates and timelines based on consideration of comments. We conclude that the final compliance dates and timelines for the MACT standards are appropriate as described previously in this section of the preamble.
The following analyses of costs and benefits, and environmental, economic, and environmental justice impacts are presented for the purpose of providing the public with an understanding of the potential consequences of this final action. The EPA notes that analysis of such impacts is distinct from the determinations finalized in this action under CAA section 112, which are based on the statutory factors the EPA discussed in sections II.A., IV.B.1., and IV.C.
The affected sources are facilities in the Coke PQBS source category and the COB source category. These sources include any facility engaged in producing coke from coal, where either the ByP process or the HNR process is used. The coke production processes include pushing coke out of ovens, quenching hot coke with water; and, for HNR facilities only, also recovering heat from hot coke oven exhaust to produce steam and, in some cases, also power. In the coke-making process, the production
There are no measurable air quality impacts from this rule that can be guaranteed. However, the promulgated 21 new MACT floor standards for the PQBS NESHAP source category will ensure that emissions of these HAP do not increase and help ensure that air quality in the vicinity of coke oven facilities does not degrade over time. In addition, the promulgated reduction in allowable emissions from coke oven doors, lids, and offtakes in the COB source category will ensure that emissions of HAP do not increase and that air quality does not degrade over time. We also are promulgating fenceline monitoring, which would improve compliance assurance and potentially result in some unquantified additional emission reductions. Lastly, we also are requiring that standards apply during periods of SSM.
The EPA has not quantified any benefits associated with this final rule, because all covered facilities are expected to already have HAP emissions levels that are below the final limits, based on facility data available to the EPA. However, the EPA anticipates that this final rule's new requirements will increase the likelihood of facilities successfully detecting any HAP emissions in excess of the specified thresholds, allowing for earlier corrective action and thus preventing pollution increases that could otherwise occur. The potential public health benefits associated with such prevention are difficult to estimate, given that they correspond to hypothetical scenarios of emissions beyond those indicated by current facility data, and are thus not quantified in the EPA's analysis
Cost impacts are due to the required source testing that includes: testing every 5 years to demonstrate compliance with the promulgated MACT floor standards for PQBS; weekly opacity testing of HNR B/W heat stacks; daily visible leak testing of HNR ovens doors; and fenceline monitoring at ByP facilities. The total costs for the rules are estimated to be $4.0 million per year for the 11 operating facilities ($2023), with $500,000 per facility, on average for the five HNR facilities and $250,000 per facility, on average, for the 6 ByP facilities. The compliance testing is estimated to cost $3.3 million total for the 11 operating facilities, with $300,000 per facility on average. The HNR B/W stack opacity testing is estimated to be $22,000 total for the five HNR facilities, with $4,400 per facility on average. The HNR daily door leak testing with EPA Method 303A is estimated to be $105,000 total for the five HNR facilities, with $21,000 per facility on average. The fenceline monitoring costs are estimated to be $640,472 for the six ByP facilities, with $107,000 per facility on average.
The EPA prepared an EIA for the final rule,
If the compliance costs, which are key inputs to an EIA, are small relative to the receipts of the affected industries, then the impact analysis may consist of a calculation of annual (or annualized) costs as a percent of sales for affected parent companies. This type of analysis is often applied when a partial equilibrium or more complex EIA approach is deemed unnecessary given the expected size of the impacts. The annualized cost per sales for a company represents the maximum price increase in the affected product or service needed for the company to completely recover the annualized costs imposed by the regulation. We conducted a cost-to-sales analysis to estimate the economic impacts of this promulgation, given that the equivalent annualized value (EAV), which represents a flow of constant annual values that would yield a sum equivalent to the present value of the compliance costs over the period 2025-2036. The EAV is estimated at $3.9 million using a 2 percent discount rate, $3.9 million using a 3 percent discount rate, and $3.7 million using a 7 percent discount rate in 2022 dollars, which is small relative to the revenues of the steel industry (of which the coke industry is a part).
There are five parent companies that operate active coke facilities: Cleveland-Cliffs, Inc. U.S. Steel, SunCoke Energy, Inc., DTE Energy Company (EES Coke in River Rouge (Detroit), Michigan), and the Drummond Company (ABC Coke in Tarrant City, Alabama). Each reported greater than $1 billion in revenue in 2021. The EPA estimated the annualized compliance cost each firm is expected to incur and determined the estimated cost-to-sales ratio for each firm is less than 0.2 percent. James C. Justice Companies owns the idled Bluestone Coke facility, and the EPA estimated the compliance cost-to-sales ratio, if the facility were to resume operations, would be less than 0.1 percent. Therefore, the projected economic impacts of the expected compliance costs of the promulgation are likely to be small. The EPA also conducted a small business screening to determine the possible impacts of the promulgated rule on small businesses. Based on the Small Business Administration size standards and business information gathered by the EPA, this source category has one small business, which would not be subject to significant cost by the promulgated requirements.
In this section of the preamble and in the EIA
With regard to emissions reductions, this rule has no quantifiable emission reductions. At this time, since these impacts are uncertain and not quantifiable, the EPA is unable to assess the total costs, benefits, and distributional consequences of these actions at the community level.
For more information on the potential benefits of this rulemaking, see section V.E. of this preamble. For additional discussion on the environmental justice analyses conducted and their results, see section V.F.
The promulgated amendments revise the standards such that they apply at all times, which includes periods of SSM, and may result in some unquantified additional emissions reductions (and associated potential public health benefits) compared to historic or current emissions (
The EPA has not quantified any benefits associated with this final rule because all covered facilities are expected to already have HAP emissions levels that are below the final limits, based on facility data available to the EPA. However, the EPA anticipates that this final rule's new requirements will increase the likelihood of facilities successfully detecting any HAP emissions in excess of the specified thresholds, allowing for earlier corrective action and thus preventing pollution increases that could otherwise occur. The potential public health benefits associated with such prevention are difficult to estimate, given that they correspond to hypothetical scenarios of emissions beyond those indicated by current facility data, and are thus not quantified in EPA's analysis.
For purposes of analyzing regulatory impacts, the EPA relies upon its June 2016 “
The EPA's environmental justice
The environmental justice analysis is presented for the purpose of providing the public with as full as possible an understanding of the potential impacts of this final action. The EPA notes that analysis of such impacts is distinct from the determinations finalized in this action under CAA sections 112, which are based solely on the statutory factors the EPA is required to consider.
The EPA examined the potential for the 12 coke oven facilities to disproportionately impact residents in certain demographic groups living in proximity to the facilities. Specifically, the EPA analyzed how demographics and risk are distributed under the PQBS NESHAP. The methodology and detailed results of the demographic analysis are presented in the document titled
To examine the potential for disproportionate impacts on certain population groups, the EPA conducted a proximity demographic analysis and a risk-based demographic analysis. A proximity demographic analysis is an assessment of individual demographic groups in the total population living within 10 km (~6.2 miles) and 50 km (~31 miles) of the affected facilities. A risk-based demographic analysis is an assessment of risks to individual demographic groups in the population living within 10 km and 50 km of the facilities. In this preamble, we focus on the 10 km radius for the demographic analysis because it encompasses all the facility MIR locations and captures 99 percent of the population with cancer risks greater than or equal to 1-in-1 million from coke ovens PQBS source category emissions. The results of the proximity analysis for populations living within 50 km are included in the document titled
The total population, population percentages, and population count for each demographic group for the entire U.S. population is shown in the column titled “Nationwide Average for Reference” in table 11 of this preamble.
The results of the category proximity demographic analysis (see table 11, column titled “Proximity Analysis for Pop. Living within 10 km of Coke Oven Facilities”) indicate that a total of 1.3 million people live within 10 km of the 12 coke oven facilities. The percent of the population that is African American is more than double the national average (28 percent versus 12 percent). The percent of people living below the poverty level is almost double the national average (21 percent versus 13 percent) and the percent of people living below twice the poverty level is above the national average (41 percent versus 30 percent).
The PQBS source category risk-based demographic analysis (see table 11 in this preamble), which focuses on populations that have higher cancer risks, indicates that there are approximately 2,500 people with cancer risks greater than or equal to 1-in-1 million living around two PQBS facilities, one in Pennsylvania and one in Virginia. Over 99 percent of the population with cancer risks greater than or equal to 1-in-1 million are living around the Virginia facility; therefore, the demographics for the population living around this facility dominates the risk-based demographics. The population with cancer risks greater than or equal to 1-in-1 million due to emissions from the PQBS source category is predominantly white (83 percent versus 60 percent nationally).
As described in section IV.B.5. of this preamble, we assessed the facility-wide (or “whole-facility”) risks for 12 coke oven facilities in order to compare the PQBS NESHAP source category risk to the whole facility risks. This whole-facility demographic analysis characterizes the risks communities face from all HAP sources at coke oven facilities. The whole facility risk assessment includes all sources of HAP emissions at each facility (described in the memorandum
The whole-facility demographic analysis is an assessment of individual demographic groups in the total population living within 10 km (~6.2 miles) and 50 km (~31 miles) of the facilities. In this preamble, we focus on the 10 km radius for the demographic analysis because it encompasses all the facility MIR locations and captures 99 percent of the population with cancer risks greater than or equal to 1-in-1 million from the PQBS NESHAP source category emissions. The results of the whole-facility demographic analysis for populations living within 50 km are included in the document titled
While the source category population with risks ≥ 1-in-1 million (shown in table 11 of this preamble) is disproportionately White (83 percent living within 10 km of coke oven facilities
This action is not subject to Executive Order 13045 because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The EPA's assessment of the potential impacts to human health from emissions at existing coke ovens sources in the PQBS source category are discussed in section IV.B. and IV.C. of this preamble.
A total of 281,000 children ages 0-17 live within 10 km of Coke Oven facilities, which is 22 percent of the total population within 10 km of Coke Ovens. This percentage is the same as the national percentage for children ages 0-17 (22 percent). Due to emissions from the PQBS source category, there are approximately 200 children (0-17 years) with increased lifetime cancer risks of greater than or equal to 1-in-1 million. This represents 8 percent of the total population living of 2,500 people within 10 km of coke ovens that have an increased lifetime cancer risk greater than or equal to 1-in-1 million due to PQBS emissions (see Table 11). Therefore, the number of children ages 0-17 living near these facilities is not disproportionately high.
Children breathe more air per unit of body weight than adults and are more susceptible to the impacts of mutagenic carcinogens and neurodevelopmental toxicants, both of which are found in COE. Because this action sets MACT standards for Hg, which is a known neurodevelopmental toxicant and was previously unregulated for this source category, and because the rule includes lower leak limits for coke ovens to minimize fugitive releases of COE, the final standards will prevent, and possibly reduce, the exposure of children to both cancer and noncancer health effects. In addition, the fenceline monitoring work practice required in the final rule, where benzene is used as a surrogate for COE, also may prevent and possibly reduce exposure of children to mutagenic carcinogens and neurodevelopmental toxicants.
The methodology and detailed results of the demographic analysis are presented in a technical report,
Additional information about these statutes and Executive Orders can be found at
This action is a “significant regulatory action” as defined under Executive Order 12866, as amended by Executive Order 14094. Accordingly, the EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. The EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis,
The information collection activities in this promulgated rule have been submitted for approval to OMB under the PRA. The ICR documents that the EPA prepared have been assigned EPA ICR numbers 1995.10 and 1362.15. You can find a copy of the ICRs in the dockets for this rule, and they are briefly summarized here.
We are promulgating amendments to the PQBS NESHAP that require compliance testing for 17 MACT limits and to the COB NESHAP that require fenceline monitoring. Furthermore, the amendments also require electronic reporting and remove the SSM exemptions in both NESHAP. We are also incorporating other revisions (
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Small entities that may be impacted by this rulemaking include Coke facilities located within an integrated iron and steel manufacturing facility under NAICS 331110 (Iron and Steel Mills and Ferroalloy Manufacturing) with 1500 or fewer employees, or facilities under NAICS 324199 (All Other Petroleum and Coal Products Manufacturing, with 500 or fewer workers. None of the facilities currently in operation that are potentially affected by this rulemaking promulgation under these size definitions are “small businesses” and therefore will not have a significant economic impact. Additional details of the analysis can be found in the EIA
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. While this action creates an enforceable duty on the private sector, the cost does not exceed $100 million or more.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, 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. No tribal governments own facilities subject to these NESHAP. Thus, Executive Order 13175 does not apply to this action.
Executive Order 13045 directs federal agencies to include an evaluation of the health and safety effects of the planned regulation on children in federal health and safety standards and explain why the regulation is preferable to potentially effective and reasonably feasible alternatives. This action is not subject to Executive Order 13045 because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments for PQBS source category are contained in section IV. of this preamble and further documented in
The EPA's
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. We have concluded this action is not likely to have any adverse energy effects.
This action involves technical standards. Therefore, the EPA conducted searches for the RTR for the PQBS NESHAP and the NESHAP for COB through the Enhanced National Standards Systems Network Database managed by the American National Standards Institute (ANSI). We also contacted voluntary consensus standards (VCS) organizations and accessed and searched their databases. For COB NESHAP, we conducted searches for EPA Methods 1, 2, 2F, 2G, 3, 3A, 3B, 4, 5, 5D, 9, 18, 22 of 40 CFR part 60, appendix A, EPA Methods 303, 303A of 40 CFR part 63, appendix A. No applicable VCS were identified for EPA Methods 2F, 2G, 5D, 22, 303, and 303A. For PQBS NESHAP, searches were conducted for EPA Methods 1, 2, 2F, 2G, 3, 3A, 3B, 4, 5, 5D, 9, 23, 26, 26A, 29 of 40 CFR part 60, appendix A, EPA Methods 316 and 320 40 CFR part 63, appendix A. No applicable VCS were identified for EPA Methods 2F, 2G, 5D, and 316.
During the EPA's VCS search, if the title or abstract (if provided) of the VCS described technical sampling and analytical procedures that are similar to the EPA's reference method, the EPA reviewed it as a potential equivalent method. We reviewed all potential standards to determine the practicality of the VCS for this rule. This review requires significant method validation data that meet the requirements of EPA Method 301 for accepting alternative methods or scientific, engineering and policy equivalence to procedures in the EPA reference methods. The EPA may reconsider determinations of impracticality when additional information is available for a particular VCS.
The EPA incorporates by reference, for 40 CFR part 63, subpart CCCCC, the VCS ANSI/ASME PTC 19.10-1981 Part 10, “Flue and Exhaust Gas Analyses,” a method for quantitatively determining the gaseous constituents of exhausts resulting from stationary combustion and includes a description of the apparatus, and calculations which are used in conjunction with Performance Test Codes to determine quantitatively, as an acceptable alternative to EPA Method 3B of appendix A to 40 CFR part 60 for the manual procedures only and not the instrumental procedures. The manual method segment of the oxygen determination is performed through the absorption of oxygen. This VCS may be obtained from
The EPA previously received approval to incorporate this method in § 63.309 (subpart L), where it appears in the amendatory text of this rule.
The EPA promulgates to incorporate by reference, for 40 CFR part 63, subparts CCCCC and L, the VCS ASTM D7520-16, “Standard Test Method for Determining the Opacity of a Plume in the Outdoor Ambient Atmosphere” is an acceptable alternative to EPA Method 9 with the following caveats:
• During the digital camera opacity technique (DCOT) certification procedure outlined in section 9.2 of ASTM D7520-16, you or the DCOT vendor must present the plumes in front of various backgrounds of color and contrast representing conditions anticipated during field use such as blue sky, trees, and mixed backgrounds (clouds and/or a sparse tree stand).
• You must also have standard operating procedures in place including daily or other frequency quality checks to ensure the equipment is within manufacturing specifications as outlined in section 8.1 of ASTM D7520-16.
• You must follow the record keeping procedures outlined in 40 CFR 63.10(b)(1) for the DCOT certification, compliance report, data sheets, and all raw unaltered JPEGs used for opacity and certification determination.
• You or the DCOT vendor must have a minimum of four (4) independent technology users apply the software to determine the visible opacity of the 300 certification plumes. For each set of 25 plumes, the user may not exceed 15 percent opacity of any one reading and the average error must not exceed 7.5 percent opacity.
The ASTM D7520-16 method describes procedures to determine the opacity of a plume, using digital imagery and associated hardware and software, where opacity is caused by PM emitted from a stationary point source in the outdoor ambient environment. The opacity of emissions is determined by the application of a DCOT that consists of a digital still camera, analysis software, and the output function's content to obtain and interpret digital images to determine and report plume opacity.
The EPA promulgates to incorporate by reference for 40 CFR part 63, subpart L, the VCS ASTM D6420-18, “Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography/Mass Spectrometry” is an acceptable alternative to EPA Method 18 only when the target compounds are all known and the target compounds are all listed in ASTM D6420 as measurable. This method should not be used for methane and ethane because atomic mass is less than 35. ASTM D6420 should never be specified as a total VOC method. This test method employs a direct interface gas chromatograph/mass spectrometer to identify and quantify 36 volatile organic compounds, however, the use of the method in this rule is only applicable to benzene, toluene, and xylene.
The EPA promulgates to incorporate by reference, for 40 CFR part 63, subpart CCCCC, the VCS ASTM D6784-16, “Standard Test Method for Elemental, Oxidized, Particle-Bound and Total Mercury Gas Generated from Coal-Fired Stationary Sources (Ontario Hydro 3 Method)” is an acceptable alternative to EPA Method 29 (portion for Hg only) as a method for measuring Hg. This method applies to concentrations of approximately 0.5-100
The EPA promulgates to incorporate by reference, for 40 CFR part 63, subpart CCCCC, the VCS ASTM D6348-12 (2020), “Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy,” as an acceptable alternative to EPA Method 320 of appendix A to 40 CFR part 63 with caveats requiring inclusion of selected annexes to the standard as mandatory. The ASTM D6348-12 (2020) method is an extractive FTIR spectroscopy-based field test method and is used to quantify gas phase concentrations of multiple target compounds in emission streams from stationary sources. This field test method provides near real time analysis of extracted gas samples. In the September 22, 2008, NTTAA summary, ASTM D6348-03(2010) was determined equivalent to EPA Method 320 with caveats. ASTM D6348-12 (2020) is a revised version of ASTM D6348-03(2010) and includes a new section on accepting the results from direct measurement of a certified spike gas cylinder, but still lacks the caveats we placed on the D6348-03(2010) version. We are finalizing that the test plan preparation and implementation in the Annexes to ASTM D 6348-12 (2020), annexes Al through A8 are mandatory; and in ASTM D6348-12 (2020) Annex A5 (Analyte Spiking Technique), the percent (%) R must be determined for each target analyte (Equation A5.5). We are finalizing that, in order for the test data to be acceptable for a compound, %R must be 70% > R ≤ 130%. If the %R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the test must be repeated for that analyte (
The ASTM methods are available at ASTM International at
Additional information for the VCS search and determinations can be found in the memorandum
The EPA is also incorporating by reference, for 40 CFR part 63, subpart L, the Quality Assurance Handbook for Air Pollution Measurement Systems, Volume IV: Meteorological Measurements, Version 2.0 (Final), March 2008 (EPA-454/B-08-002). The Quality Assurance Handbook for Air Pollution Measurement Systems; Volume IV: Meteorological Measurements is an EPA developed guidance manual for the installation, operation, maintenance and calibration of meteorological systems including the wind speed and direction using anemometers, temperature using thermistors, and atmospheric pressure using aneroid barometers, as well as the calculations for wind vector data for on-site meteorological measurements. This VCS may be obtained from the EPA's National Service Center for Environmental Publications (
The EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns.
As discussed in section V.F. of this preamble, the population with risks greater than or equal to 1-in-1 million due to emissions from all sources of HAP at coke oven facilities is disproportionately (30 percent) African American compared to the national average (12 percent African American). About 83 percent of the 491,000 people with a cancer risk greater than or equal to 1-in-1 million live within 10 km of 3 facilities—two in Alabama and one in Pennsylvania. The population with cancer risks greater than or equal to 1-in-1 million living within 10 km of the two facilities in Alabama is 56 percent African American, which is significantly higher than the national average of 12 percent. In addition, the population with risks ≥ 1-in-1 million due to emissions from all sources of HAP at coke oven facilities that is below the poverty level (17 percent) is above the national average (13 percent).
The EPA believes that this action is not likely to change existing disproportionate and adverse effects on communities with environmental justice concerns. Although the promulgated measures are not estimated to decrease actual emissions or the number of people who have risks greater than or equal to 1-in-1 million due to HAP emissions (see table 12 of this preamble), this action will limit allowable emissions from coke ovens sources in 40 CFR part 63, subparts CCCCC and L. The EPA also is promulgating that coke oven facilities conduct fenceline monitoring for benzene and report these data electronically to the EPA. The fenceline monitoring requirements will help ensure that emissions from sources listed under CAA section 112 are being appropriately controlled. The fenceline monitoring results will be publicly available on a quarterly basis to ensure transparency and, consequently, provide fenceline communities with greater access to information about potential exposures.
The information supporting this Executive Order review is described in section V.F. of this preamble and in the document
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedures, Air pollution control, Hazardous substances, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(f) * * *
(1) ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analyses [Part 10, Instruments and Apparatus], issued August 31, 1981; IBR approved for §§ 63.309(k); 63.365(b); 63.457(k); 63.772(e) and (h); 63.865(b); 63.997(e); 63.1282(d) and (g); 63.1450(a), (b), (d), (e), and (g); 63.1625(b); table 5 to subpart EEEE; §§ 63.3166(a); 63.3360(e); 63.3545(a); 63.3555(a); 63.4166(a); 63.4362(a); 63.4766(a); 63.4965(a); 63.5160(d); table 4 to subpart UUUU; table 3 to subpart YYYY; table 4 to subpart AAAAA; § 63.7322(b); table 5 to subpart DDDDD; §§ 63.7822(b); 63.7824(e); 63.7825(b); 63.8000(d); table 4 to subpart JJJJJ; table 4 to subpart KKKKK; §§ 63.9307(c); 63.9323(a); 63.9621(b) and (c);table 4 to subpart SSSSS; tables 4 and 5 of subpart UUUUU; table 1 to subpart ZZZZZ; §§ 63.11148(e); 63.11155(e); 63.11162(f); 63.11163(g); table 4 to subpart JJJJJJ; §§ 63.11410(j); 63.11551(a); 63.11646(a); 63.11945.
(i) * * *
(88) ASTM D6348-12 (Reapproved 2020), Standard Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform Infrared (FTIR) Spectroscopy, Approved February 1, 2012; IBR approved for §§ 63.365(b); 63.7322(d), (e), and (g); 63.7825(g) and (h).
(96) ASTM D6420-18, Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry, approved November 1, 2018, IBR approved for §§ 63.305(c); 63.987(b); 63.997(e); 63.2354(b); table 5 to subpart EEEE; §§ 63.2450(j); 63.8000(d).
(105) ASTM D6784-16, Standard Test Method for Elemental, Oxidized, Particle-Bound and Total Mercury in Flue Gas Generated from Coal-Fired Stationary Sources (Ontario Hydro Method), Approved March 1, 2016; IBR approved for §§ 63.1450(d); 63.9621; table 5 to subpart UUUUU; appendix A to subpart UUUUU; § 63.7322(c).
(110) ASTM D7520-16, Standard Test Method for Determining the Opacity of a Plume in the Outdoor Ambient Atmosphere, approved April 1, 2016; IBR approved for §§ 63.301; 63.305(c) and (f); 63.309(d), (j), and (m); 63.311(d); 63.1450(c) (e), and (g); 63.1453(h); 63.1625(b); 63.7334(a); §§ 63.7823(c) through (f), 63.7833(g); table 3 to subpart LLLLL; § 63.11423(c).
(o) * * *
(3) EPA-454/B-08-002, Quality Assurance Handbook for Air Pollution Measurement Systems, Volume IV: Meteorological Measurements, Version 2.0 (Final), March 2008, IBR approved for §§ 63.314(b); 63.7792(b).
(f) * * *
(1) ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analyses [Part 10, Instruments and Apparatus], issued August 31, 1981; §§ 63.116(c) and (h); 63.128(a); 63.145(i); 63.309(k); 63.365(b); 63.457(k); 63.490(g); 63.772(e) and (h); 63.865(b); 63.997(e); 63.1282(d) and (g); 63.1450(a), (b), (d). (e), (g); 63.1625(b); table 5 to subpart EEEE; §§ 63.3166(a); 63.3360(e); 63.3545(a); 63.3555(a); 63.4166(a); 63.4362(a); 63.4766(a); 63.4965(a); 63.5160(d); table 4 to subpart UUUU; table 3 to subpart YYYY; table 4 to subpart AAAAA; § 63.7322(b); table 5 to subpart DDDDD; §§ 63.7822(b); 63.7824(e); 63.7825(b); 63.8000(d); table 4 to subpart JJJJJ; table 4 to subpart KKKKK; §§ 63.9307(c); 63.9323(a); 63.9621(b) and (c);table 4 to subpart SSSSS; tables 4 and 5 of subpart UUUUU; table 1 to subpart ZZZZZ; §§ 63.11148(e); 63.11155(e); 63.11162(f); 63.11163(g); table 4 to subpart JJJJJJ; §§ 63.11410(j); 63.11551(a); 63.11646(a); 63.11945.
(i) * * *
(89) ASTM D6348-12 (Reapproved 2020), Standard Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform Infrared (FTIR) Spectroscopy, Approved February 1, 2012; IBR approved for §§ 63.109(a); 63.365(b); 63.509(a); 63.7322(d), (e), and (g); 63.7825(g) and (h).
(96) ASTM D6420-18, Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry, approved November 1, 2018' IBR approved for §§ 63.101(b); 63.115(g); 63.116(c); 63.126(d); 63.128(a); 63.139(c); 63.145(d) and (i); 63.150(g); 63.180(d; 63.305(c); 63.482(b); 63.485(t); 63.488(b); 63.490(c) and (e); 63.496(b); 63.500(c); 63.501(a); 63.502(j); 63.503(a) and (g); 63.525(a) and (e); 63.987(b); 63.997(e); 63.2354(b); table 5 to subpart EEEE; §§ 63.2450(j); 63.8000(d).
(b) The provisions for new sources in §§ 63.302(b) and (c) and 63.303(b) apply to each greenfield coke oven battery and to each new or reconstructed coke oven battery at an existing coke plant if the changes to or addition of a coke oven battery results in an increase in the design capacity of the coke plant as of
(e) The emission limitations set forth in this subpart shall apply at all times. At all times, the owner or operator must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.
The additions and revisions read as follows:
The addition and revision read as follows:
(a) * * *
(4) On and after July 7, 2025:
(i) for facilities with coke production capacity more than or equal to 3 million tpy coke and as determined by the procedures in § 63.309(d)(1), 2.5 percent leaking coke oven doors for each tall by-product coke oven battery and 1.7 percent leaking coke oven doors for each not tall by-product coke oven battery;
(ii) for facilities with coke production capacity less than 3 million tpy coke and as determined by the procedures in § 63.309(d)(1), 3.8 percent leaking coke oven doors for each tall by-product coke oven battery and 3.2 percent leaking coke oven doors for each not tall by-product coke oven battery;
(iii) 0.32 percent leaking topside port lids, as determined by the procedures in § 63.309(d)(1);
(iv) 2.1 percent leaking offtake system(s), as determined by the procedures in § 63.309(d)(1); and
(v) 12 seconds of visible emissions per charge, as determined by the procedures in § 63.309(d)(2).
(d) Emission limitations and requirements applied to each coke oven battery utilizing a new recovery technology shall be less than the following emission limitations or shall result in an overall annual emissions rate for coke oven emissions for the battery that is lower than that obtained by the following emission limitations on and after July 7, 2025:
(1) Coke oven doors on by-product coke oven batteries at facilities with production capacity more than or equal to 3 million tpy coke:
(i) 2.5 percent leaking coke oven doors on tall by-product coke oven batteries, as defined in § 63.301 and as determined by the procedures in § 63.309(d)(1); and
(ii) 1.7 percent leaking coke oven doors for each not tall by-product coke oven battery, as determined by the procedures in § 63.309(d)(1);
(2) For coke oven doors on by-product coke oven batteries at facilities with coke production capacity less than 3 million tpy coke:
(i) 3.8 percent leaking coke oven doors on tall by-product coke oven batteries, as determined by the procedures in § 63.309(d)(1); and
(ii) 3.2 percent leaking coke oven doors on not tall by-product coke oven batteries, as determined by the procedures in § 63.309(d)(1);
(3) 2.1 percent leaking offtake system(s), as determined by the procedures in § 63.309(d)(1);
(4) 0.32 percent leaking topside port lids, as determined by the procedures in § 63.309(d)(1); and
(5) 12 seconds of visible emissions per charge, as determined by the procedures in § 63.309(d)(2).
(a) * * *
(1) For coke oven doors and common tunnels;
(i) 0.0 percent leaking coke oven doors, as determined by the procedures in § 63.309(d)(1); and
(ii) The owner or operator shall monitor and record, once per day for each day of operation, the pressure in each oven or in each common battery tunnel during pushing, charging, and coking to ensure that the ovens are operated under a negative pressure.
(iii) The date for compliance with (a)(1)(i) and (ii) of this section is on and after July 7, 2025.
(b) * * *
(1) For coke oven doors and common tunnels;
(i) 0.0 percent leaking coke oven doors, as determined by the procedures in § 63.309(d)(1); and
(ii) The owner or operator shall monitor and record, once per day for each day of operation, the pressure in each oven or in each common battery tunnel during pushing, charging, and coking to ensure that the ovens are operated under a negative pressure.
(iii) The date for compliance with (b)(1)(i) and (ii) of this section is on and after July 7, 2025, or upon initial startup, whichever is later.
(c) Except as provided in § 63.304(a), (b), and (d), the owner or operator of any nonrecovery coke oven battery shall meet the work practice standards in paragraphs (c)(1) and (2) of this section.
The revision and addition read as follows:
(b) * * *
(6) The owner or operator of a cold-idle coke oven battery that shut down prior to November 15, 1990, shall submit a written request to the Administrator to include the battery in the design capacity of a coke plant as of November 15, 1990. A copy of the request shall also be sent to Director, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. The Administrator will review and approve or disapprove a request according to the following procedures:
(i) Requests will be reviewed for completeness in the order received. A complete request shall include:
(A) Battery identification;
(B) Design information, including the design capacity and number and size of ovens; and
(C) A brief description of the owner or operator's plans for the cold-idle battery, including a statement whether construction of a padup rebuild or a brownfield coke oven battery is contemplated.
(ii) A complete request shall be approved if the design capacity of the battery and the design capacity of all previous approvals does not exceed the capacity limit in paragraph (b)(6)(i)(C) of this section.
(iii) The total nationwide coke capacity of coke oven batteries that receive approval under paragraph (b)(6) of this section shall not exceed 2.7 million Mg/yr (3.0 million ton/yr).
(iv) If a construction permit is required, an approval shall lapse if a construction permit is not issued within 3 years of the approval date, or if the construction permit lapses.
(v) If a construction permit is not required, an approval will lapse if the battery is not restarted within 2 years of the approval date.
(7) The owner or operator of a by-product coke oven battery with fewer than 30 ovens may elect to comply with an emission limitation of 2 or fewer leaking coke oven doors, as determined by the procedures in § 63.309(d)(4), as an alternative to the emission limitation for coke oven doors in paragraphs (b)(2)(i), (b)(3) (i) through (ii), (b)(4)(i), (b)(5), and (b)(6) of this section.
(8) On and after July 7, 2025:
(i) 2.5 percent leaking coke oven doors on each tall by-product coke oven battery and for each by-product coke oven battery owned or operated by a foundry coke producer, as determined by the procedures in § 63.309(d)(1) for facilities with production capacity greater than 3 million tpy coke or 1.7 percent leaking coke oven doors for each not tall by-product coke oven battery and for each by-product coke oven battery owned or operated by a foundry coke producer, as determined by the procedures in § 63.309(d)(1) for facilities with production capacity greater than 3 million tpy coke; and
(ii) 3.8 percent leaking coke oven doors on each tall by-product coke oven battery and for each by-product coke oven battery owned or operated by a foundry coke producer, as determined by the procedures in § 63.309(d)(1) for facilities with production capacity less than 3 million tpy coke or 3.2 percent leaking coke oven doors for each not tall by-product coke oven battery and for each by-product coke oven battery owned or operated by a foundry coke producer, as determined by the procedures in § 63.309(d)(1) for facilities with production capacity less than 3 million tpy coke.
The addition and revisions read as follows:
(c) * * *
(3) * * *
(iii) Alternatively, ASTM D7520-16, (incorporated by reference, see § 63.14) may be used with the following conditions:
(A) During the digital camera opacity technique (DCOT) certification procedure outlined in section 9.2 of ASTM D7520-16 (incorporated by reference, see § 63.14), the owner or operator or the DCOT vendor must present the plumes in front of various backgrounds of color and contrast representing conditions anticipated during field use such as blue sky, trees, and mixed backgrounds (clouds and/or a sparse tree stand).
(B) The owner or operator must also have standard operating procedures in place including daily or other frequency quality checks to ensure the equipment is within manufacturing specifications as outlined in section 8.1 of ASTM D7520-16 (incorporated by reference, see § 63.14).
(C) The owner or operator must follow the recordkeeping procedures outlined in § 63.10(b)(1) for the DCOT certification, compliance report, data sheets, and all raw unaltered JPEGs used for opacity and certification determination.
(D) The owner or operator or the DCOT vendor must have a minimum of four independent technology users apply the software to determine the visible opacity of the 300 certification plumes. For each set of 25 plumes, the user may not exceed 15 percent opacity of anyone reading and the average error must not exceed 7.5 percent opacity.
(E) Use of this approved alternative does not provide or imply a certification or validation of any vendor's hardware or software. The onus to maintain and verify the certification and/or training of the DCOT camera, software, and operator in accordance with ASTM D7520-16 (incorporated by reference, see § 63.14) and these requirements is on the facility, DCOT operator, and DCOT vendor.
(5) * * *
(ii) * * *
(A) Measure the total emission rate of benzene, toluene, and xylene exiting the control device using Method 18 in appendix A-6 to 40 CFR part 60 and the emission rate of benzene soluble organics entering the control device as described in the test plan submitted pursuant to paragraph (b) of this section. The voluntary consensus standard ASTM D6420-18, (incorporated by reference, see § 63.14) is an acceptable alternative to EPA Method 18 for benzene, toluene, and xylene; or
(f) * * *
(4) The opacity of emissions from the control device for the shed shall be monitored in accordance with the requirements of either paragraph (f)(4)(i) or (ii) of this section, at the election of the owner or operator.
(i) The owner or operator shall install, operate, and maintain a continuous opacity monitor, and record the output of the system, for the measurement of the opacity of emissions discharged from the emission control system per §§ 63.300(e) and 63.8(d)(1) and (2).
(A) Each continuous opacity monitoring system shall meet the requirements of Performance Specification 1 in appendix B to 40 CFR part 60; and
(B) Each continuous opacity monitoring system shall be operated, calibrated, and maintained according to the procedures and requirements specified in 40 CFR part 52; and
(C) The owner or operator shall keep the written procedures required by § 63.8(d)(1) and (2) on record for the life of the affected source or until the affected source is no longer subject to the provisions of this part, to be made available for inspection, upon request, by the Administrator. If the performance evaluation plan is revised, the owner or operator shall keep previous (
(ii) A certified observer shall monitor and record at least once each day during daylight hours, opacity observations for the control device for the shed using Method 9 in appendix A-4 to 40 CFR part 60. Alternatively, ASTM D7520-16, (incorporated by reference, see § 63.14) may be used with the following conditions:
(A) During the digital camera opacity technique (DCOT) certification procedure outlined in section 9.2 of ASTM D7520-16 (incorporated by reference, see § 63.14), the owner or operator or the DCOT vendor must present the plumes in front of various backgrounds of color and contrast representing conditions anticipated during field use such as blue sky, trees, and mixed backgrounds (clouds and/or a sparse tree stand).
(B) The owner or operator must also have standard operating procedures in place including daily or other frequency quality checks to ensure the equipment is within manufacturing specifications as outlined in section 8.1 of ASTM D7520-16 (incorporated by reference, see § 63.14).
(C) The owner or operator must follow the recordkeeping procedures outlined
(D) The owner or operator or the DCOT vendor must have a minimum of four independent technology users apply the software to determine the visible opacity of the 300 certification plumes. For each set of 25 plumes, the user may not exceed 15 percent opacity of anyone reading and the average error must not exceed 7.5 percent opacity.
(E) Use of this approved alternative does not provide or imply a certification or validation of any vendor's hardware or software. The onus to maintain and verify the certification and/or training of the DCOT camera, software, and operator in accordance with ASTM D7520-16 (incorporated by reference, see § 63.14) and these requirements is on the facility, DCOT operator, and DCOT vendor.
(a) Except as otherwise provided, a daily performance test shall be conducted each day, 7 days per week for each new and existing coke oven battery, the results of which shall be used in accordance with procedures specified in this subpart to determine compliance with each of the applicable visible emission limitations for coke oven doors, topside port lids, offtake systems, and charging operations in this subpart. If a facility pushes and charges only at night, then that facility must, at its option, change their schedule and charge during daylight hours or provide adequate lighting so that visible emission inspections can be made at night. “Adequate lighting” will be determined by the enforcement agency. The performance test should be based on representative performance (
(d) * * *
(1) The 30-run rolling average of the percent leaking coke oven doors, topside port lids, and offtake systems on each coke oven battery, using the equations in sections 12.5, 12.6, and 12.7 of Method 303 (or section 12 of Method 303A) in appendix A to this part;
(2) For by-product coke oven battery charging operations, the logarithmic 30-day rolling average of the seconds of visible emissions per charge for each battery, using the equation in section 12.4 of Method 303 in appendix A to this part;
(5) For an approved alternative emission limitation for coke oven doors according to § 63.305, the weekly or monthly observation of the percent leaking coke oven doors using Method 303 in appendix A to this part, the percent opacity of visible emissions from the control device for the shed using Method 9 in appendix A-4 to 40 CFR part 60 or ASTM D7520-16 (incorporated by reference, see § 63.14), and visible emissions from the shed using Method 22 in appendix A-7 to 40 CFR part 60;
(g) Compliance with the alternative standards for nonrecovery coke oven batteries in § 63.303; shed inspection, maintenance requirements, and monitoring requirements for parameters affecting the shed exhaust or pushing/charging machine or equivalent device flow rate for batteries subject to alternative standards for coke oven doors under § 63.305; work practice emission control plan requirements in § 63.306; standards for bypass/bleeder stacks in § 63.307; and standards for collecting mains in § 63.308 is to be determined by the enforcement agency based on review of records and inspections.
(j) * * *
(1) Using a certified observer, determine the average opacity of five consecutive charges per week for each charging emissions capture system if charges can be observed according to the requirements of Method 9 in appendix A-4 to 40 CFR part 60 or ASTM D7520-16 (as applicable; incorporated by reference, see § 63.14), except as specified in paragraphs (j)(1)(i) and (ii) of this section.
(i) Instead of the procedures in section 2.4 of Method 9 in appendix A-4 to 40 CFR part 60 or section 8.4 of ASTM D7520-16 (as applicable; incorporated by reference, see § 63.14), record observations to the nearest 5 percent at 15-second intervals for at least five consecutive charges.
(ii) Instead of the procedures in section 2.5 of Method 9 in appendix A-4 to 40 CFR part 60 or section 8.5 of ASTM D7520-16 (as applicable; incorporated by reference, see § 63.14), determine and record the highest 3-minute average opacity for each charge from the consecutive observations recorded at 15-second intervals.
(k) The owner or operator of a new nonrecovery coke oven battery shall conduct a performance test to demonstrate initial compliance with the emission limitations for a charging emissions control device in § 63.303(d)(2) within 180 days of the compliance date that is specified for the affected source in § 63.300(a)(4) and report the results in the notification of compliance status. The owner or operator shall prepare a site-specific test plan according to the requirements in § 63.7(c) and shall conduct each performance test according to the requirements in paragraphs (a) and (k)(1) through (4) of this section.
(1) Determine the concentration of PM according to the following test methods in appendices A-1 through A-3 to 40 CFR part 60
(iii) Method 3, 3A, or 3B to determine the dry molecular weight of the stack gas. You may also use as an alternative to Method 3B, the manual method (but not instrumental procedures) for measuring the oxygen, carbon dioxide, and carbon monoxide content of exhaust gas, ANSI/ASME PTC 19.10-1981 (incorporated by reference, see § 63.14).
(m) Visible emission observations of a charging emissions control device required by § 63.303(d)(3)(iii) must be performed by a certified observer according to Method 9 in appendix A-4 to 40 CFR part 60 or ASTM D7520-16 (as applicable; incorporated by reference, see § 63.14) for one 6-minute period.
The revisions and additions read as follows:
(d)
(1) Certification, signed by the owner or operator, that no coke oven gas was vented, except through the bypass/bleeder stack flare system of a by-product coke oven battery during the reporting period or that a venting report has been submitted according to the requirements in paragraph (e) of this section.
(2) Certification, signed by the owner or operator, that work practices were implemented if applicable under § 63.306.
(3) Certification, signed by the owner or operator, that all work practices for nonrecovery coke oven batteries were implemented as required in § 63.303(b)(3).
(4) Certification, signed by the owner or operator, that all coke oven door leaks on a nonrecovery battery were stopped according to the requirements in § 63.303(c)(2) and (3). If a coke oven door leak was not stopped according to the requirements in § 63.303(c)(2) and (3), or if the door leak occurred again during the coking cycle, the owner or operator must report the information in paragraphs (d)(4)(i) through (iv) of this section.
(i) The oven number of each coke oven door for which a leak was not stopped according to the requirements in § 63.303(c)(2) and (3) or for a door leak that occurred again during the coking cycle.
(ii) The total duration of the leak from the time the leak was first observed.
(iii) The cause of the leak (including unknown cause, if applicable), any actions taken to minimize emissions in accordance with and § 63.300(e), the corrective action taken to stop the leak.
(iv) Whether the failure occurred during a period of startup, shutdown or malfunction.
(5) Certification, signed by the owner or operator, that the opacity of emissions from charging operations for a new nonrecovery coke oven battery did not exceed 20 percent. If the opacity limit in § 63.303(d)(1) was exceeded, the owner or operator must report the number, duration, and cause of the deviation (including unknown cause, if applicable), and the corrective action taken
(6) Before September 3, 2024, report the results of any PM performance test for a charging emissions control device for a new nonrecovery coke oven battery conducted during the reporting period as required in § 63.309(l). Beginning on September 3, 2024, report PM performance test results according to paragraph (i) of this section.
(7) Certification, signed by the owner or operator, that all work practices for a charging emissions control device for a new nonrecovery coke oven battery were implemented as required in § 63.303(d)(3). If a Method 9 in appendix A-4 to 40 CFR part 60 or ASTM D7520-16 (as applicable; incorporation by reference, see § 63.14) visible emissions observation exceeds 10 percent, the owner or operator must report the duration and cause of the deviation (including unknown cause, if applicable), and the corrective action taken.
(8) Certification, signed by the owner or operator, that all work practices for oven dampers on a new nonrecovery coke oven battery were implemented as required in § 63.303(d)(4).
(9) Facility name and address (including the county) and the beginning and ending date of the reporting period.
(e)
(f)
(1) * * *
(iv) Records to demonstrate compliance with the work practice requirement for door leaks in § 63.303(c). These records must include the oven number of each leaking door, total duration of the leak from the time the leak was first observed, the cause of the leak (including unknown cause, if applicable), the corrective action taken to return the affected unit to its normal or usual manner operation, and the amount of time taken to stop the leak from the time the leak was first observed. Beginning on January 2, 2025, an estimate of the quantity of each regulated pollutant emitted over any emission limit, a description of the method used to estimate the emissions, and whether the failure occurred during a period of startup, shutdown or malfunction. If you failed to meet an applicable standard, the compliance report must include the start date, start time, cause, and duration (in hours) of each failure. For each failure, beginning on January 2, 2025, the compliance report must include a list of the affected sources or equipment, actions taken to minimize emissions, an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
(2) * * *
(ii) * * *
(A) Records of opacity readings from the continuous opacity monitor for the control device for the shed. Beginning on January 2, 2025, if you failed to meet an applicable standard, the compliance report must include whether the failure occurred during a period of startup, shutdown, or malfunction of process, air pollution control, and monitoring equipment; the start date, start time, and duration (in hours) of each failure; and any corrective actions taken to return the affected unit to its normal or usual manner of operation. For each failure, beginning on January 2, 2025, the compliance report must include a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the
(g)
(1) Requests under paragraph (g) of this section shall be submitted in writing or electronically, and shall identify the records or reports that are subject to the request with reasonable specificity;
(h)
(i)
(j)
(1) Facility name and address (including the county).
(2) Year and reporting quarter (
(3) For each passive tube monitor: The latitude and longitude location coordinates; the sampler name; and identification of the type of sampler (
(4) The beginning and ending dates for each sampling period.
(5) Individual sample results for benzene reported in units of micrograms per cubic meter (
(6) Data flags that indicate each monitor that was skipped for the sampling period, if the owner or operator uses an alternative sampling frequency under § 63.314(a)(2)(iii).
(7) Data flags for each outlier determined in accordance with section 9.2 of Method 325A in appendix A to this part. For each outlier, the owner or operator must submit the individual sample result of the outlier, as well as the evidence used to conclude that the result is an outlier.
(8) The biweekly concentration difference (Δc) for benzene for each sampling period and, beginning the first quarterly report with sufficient data to calculate an annual average, the annual average Δc for benzene for each sampling period.
(9) Indication of whether the owner or operator was required to develop a corrective action plan under § 63.314(e) of this subpart.
(k)
(1) The EPA will make all the information submitted through CEDRI available to the public without further notice to you. Do not use CEDRI to submit information you claim as CBI. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim for some of the information submitted under paragraphs (h) or (i) of this section, you must submit a complete file, including information claimed to be CBI, to the EPA.
(2) For performance test reports according to paragraph (j) of this section, the file must be generated using the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website.
(3) Clearly mark the part or all of the information that you claim to be CBI. Information not marked as CBI may be authorized for public release without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
(4) The preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol, or other online file sharing services. Electronic submissions must be transmitted directly to the OAQPS CBI Office at the email address
(5) If you cannot transmit the file electronically, you may send CBI information through the postal service to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Group Leader, Measurement Policy Group or Coke Oven Sector Lead as indicated in paragraph (k)(4) of this section. The mailed CBI material should be double wrapped and clearly marked. Any CBI
(6) All CBI claims must be asserted at the time of submission. Anything submitted using CEDRI cannot later be claimed CBI. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available.
(7) You must submit the same file submitted to the CBI office with the CBI omitted to the EPA via the EPA's CDX as described in paragraphs (h), (i), or (j) of this section.
(l)
(1) Coordinates of all fenceline monitors, including co-located samplers and field blanks, and if applicable, the meteorological station. The owner or operator shall determine the coordinates using an instrument with an accuracy of at least 3 meters. The coordinates shall be in decimal degrees with at least five decimal places.
(2) The start and stop times and dates for each sample, as well as the tube identifying information.
(3) Sampling period average temperature and barometric pressure measurements.
(4) For each outlier determined in accordance with Section 9.2 of Method 325A in appendix A to this part, the sampler location of and the concentration of the outlier and the evidence used to conclude that the result is an outlier.
(5) For samples that will be adjusted for a background, the location of and the concentration measured simultaneously by the background sampler(s), and the perimeter samplers to which it applies.
(6) Individual sample results, the calculated Δc for benzene for each sampling period and the two samples used to determine it, whether background correction was used, and the annual average Δc calculated after each sampling period.
(7) Method detection limit for each sample, including co-located samples and blanks.
(8) Documentation of the root cause analysis and any corrective action taken each time the action level was exceeded, including the dates the root cause analysis was initiated and the resulting correction action(s) were taken.
(9) Any corrective action plan developed under § 63.314(e).
(10) Other records as required by Methods 325A and 325B in appendix A to this part.
(11) If a near-field source correction is used as provided in § 63.314(f), or if an alternative test method is used that provides time-resolved measurements, records of hourly meteorological data, including temperature, barometric pressure, wind speed and wind direction, calculated daily unit vector wind direction and daily sigma theta, and other records specified in the site-specific monitoring plan.
(d) * * *
(6) Approval of an alternative to any electronic reporting to the EPA required by this subpart.
For each by-product coke oven battery facility as defined in § 63.301 of this subpart, beginning no later than July 7, 2025, the owner or operator of a coke manufacturing facility shall conduct sampling along the facility property boundary and analyze the samples in accordance with paragraphs (a) through (g) of this section.
(a) The owner or operator must conduct sampling along the facility property boundary and analyze the samples in accordance with Methods 325A and 325B in appendix A to this part and paragraphs (a)(1) through (a)(2) of this section. The monitoring perimeter may be located within the facility, inside the facility property boundary. However, the monitoring perimeter must encompass all potential sources of benzene that are located within the facility's property boundary.
(1) The target analyte is benzene. The owner or operator must follow the procedure in section 9.6 of Method 325B in appendix A to this part to determine the detection limit of benzene for each sampler used to collect samples and blanks.
(2) The owner or operator must use a sampling period and sampling frequency as specified in paragraphs (a)(2)(i) through (a)(2)(iii) of this section.
(i) A 14-day sampling period must be used unless a shorter sampling period is determined to be necessary under paragraph (e) or (g) of this section. A sampling period is defined as the period during which a sampling tube is deployed at a specific sampling location with the diffusive sampling end cap in-place and does not include the time required to analyze the sample. For the purpose of this subpart, a 14-day sampling period may be no shorter than 13 calendar days and no longer than 15 calendar days, but the routine sampling period must be 14 calendar days.
(ii) Except as provided in paragraph (a)(2)(iii) of this section, the frequency of sample collection must be once each contiguous 14-day sampling period, such that the beginning of the next 14-day sampling period begins immediately upon the completion of the previous 14-day sampling period.
(iii) When an individual monitor consistently achieves results for benzene at or below the level specified in paragraph (a)(3) of this section, the owner or operator may elect to use the applicable minimum sampling frequency specified in paragraphs (a)(2)(iii)(A) through (E) of this section for that monitoring site. When calculating Δc for the monitoring period when using this alternative for burden reduction, use zero for the lowest sampling result for each monitoring period where one or more samples was not taken and/or analyzed for benzene.
(A) If every sample at a monitoring site is at or below the level specified in paragraph (a)(3) of this section for 2 years (52 consecutive samples), every other sampling period can be skipped for that monitoring site,
(B) If every sample at a monitoring site that is monitored at the frequency specified in paragraph (a)(2)(iii)(A) of this section is at or below the level specified in paragraph (a)(3) of this section for 2 years (
(C) If every sample at a monitoring site that is monitored at the frequency specified in paragraph (a)(2)(iii)(B) of this section is at or below the level specified in paragraph (a)(3) of this section for 2 years (
(D) If every sample at a monitoring site that is monitored at the frequency specified in paragraph (a)(2)(iii)(C) of this section is at or below the level specified in paragraph (a)(3) of this section for 2 years (
(E) If at any time a sample for a monitoring site that is monitored at the frequency specified in paragraph (a)(2)(iii)(A) through (D) of this section returns a result that is above the level specified in paragraph (a)(3) of this section, the sampling site must return to the original sampling requirements of contiguous 14-day sampling periods with no skip periods for one quarter (six 14-day sampling periods). If every sample collected during this quarter is at or below the level specified in paragraph (a)(3) of this section, the owner or operator may revert back to the reduced monitoring schedule applicable for that monitoring site prior to the sample reading exceeding the level specified in paragraph (a)(3) of this section. If any sample collected during this quarter is above the level specified in paragraph (a)(3) of this section, that monitoring site must return to the original sampling requirements of contiguous 14-day sampling periods with no skip periods for a minimum of two years. The burden reduction requirements can be used again for that monitoring site once the requirements of paragraph (a)(2)(iii)(A) of this section are met again,
(3) To use the alternative sampling frequency outlined in paragraph (a)(2) of this section, an individual monitor must consistently achieve results for benzene at or below 0.7
(b) The owner or operator shall collect and record meteorological data according to the applicable requirements in paragraphs (b)(1) through (3) of this section.
(1) If a near-field source correction is used as provided in paragraph (f)(2) of this section and/or if an alternative test method is used that provides time-resolved measurements, the owner or operator must use an on-site meteorological station in accordance with section 8.3 of Method 325A in appendix A to this part. Collect and record hourly average meteorological data, including temperature, barometric pressure, wind speed and wind direction, and calculate daily unit vector wind direction and daily sigma theta.
(2) For cases other than those specified in paragraph (b)(1) of this section, the owner or operator shall collect and record sampling period average temperature and barometric pressure using either an on-site meteorological station in accordance with section 8.3 of Method 325A in appendix A to this part or, alternatively, using data from a National Weather Service (NWS) meteorological station provided the NWS meteorological station is within 40 kilometers (25 miles) of the coke manufacturing facility.
(3) If an on-site meteorological station is used, the owner or operator shall follow the calibration and standardization procedures for meteorological measurements in EPA-454/B-08-002 (incorporated by reference, see § 63.14).
(c) Within 45 days of completion of each sampling period, the owner or operator shall determine whether the results are above or below the action level as follows.
(1) The owner or operator must determine the facility impact on the benzene concentration (Δc) for each sampling period according to either paragraph (c)(1)(i) or (ii) of this section, as applicable.
(i) Except when near-field source correction is used as provided in paragraph (c)(1)(ii) of this section, the owner or operator shall determine the highest and lowest sample results for benzene concentrations from the sample pool and calculate Δc as the difference in these concentrations. Co-located samples must be averaged together for the purposes of determining the benzene concentration for that sampling location, and, if applicable, for determining Δc. The owner or operator shall adhere to the following procedures when one or more samples for the sampling period are below the method detection limit for benzene:
(A) If the lowest detected value of benzene is below detection, the owner or operator shall use zero as the lowest sample result when calculating Δc.
(B) If all sample results are below the method detection limit, the owner or operator shall use the method detection limit as the highest sample result and zero as the lowest sample result when calculating Δc.
(C) In the case of co-located samples, if one sample is above the method detection limit while the other sample is below the method detection limit, the owner or operator must use the method detection limit as the result for the sample that is below the method detection limit for purposes of averaging the results to determine the concentration at a particular sampling location, and, if applicable, for determining Δc.
(ii) When near-field source correction is used as provided in paragraph (f)(2) of this section, the owner or operator must determine Δc using the calculation protocols outlined in paragraph (c)(1)(i) of this section except as provided in this paragraph (c)(1)(ii), and the additional requirements in paragraph (f)(2) of this section, as well as any additional requirements outlined in the approved site-specific monitoring plan. The Δc for the sampling period is equal to the higher of the values in paragraphs (c)(1)(ii)(A) and (B) of this section.
(A) The highest corrected sample result from a sampling location where near-field source correction is used during the sampling period.
(B) The difference in concentration between the highest sample result that was not corrected for a near-field source during the sampling period and the lowest sample result for the sampling period.
(2) The owner or operator must calculate the annual average Δc based on the average of the 26 most recent 14-day sampling periods. The owner or operator must update this annual average value after receiving the results of each subsequent 14-day sampling period.
(3) The action level for benzene is 7
(d) Once the action level in paragraph (c)(3) of this section has been exceeded, the owner or operator must take the following actions to bring the annual average Δc back below the action level.
(1) Within 5 days of updating the annual average value as required in paragraph (c)(2) of this section and determining that the action level in paragraph (c)(3) of this section has been exceeded (
(i) Root cause analysis may include, but is not limited to:
(A) Leak inspection using Method 21 in appendix A-7 to 40 CFR part 60, optical gas imaging, or handheld monitors.
(B) Visual inspection to determine the cause of the high benzene emissions.
(C) Employing progressively more frequent sampling, analysis and meteorology (
(D) Operator knowledge of process changes (
(ii) If the root cause cannot be identified using the type of techniques described in paragraph (d)(1)(i) of this section, the owner or operator must employ more frequent sampling and analysis to determine the root cause of the exceedance.
(A) The owner or operator may first employ additional monitoring points and shorter sampling periods for Methods 325A and 325B in appendix A to this part for benzene to determine the root cause of the exceedance.
(B) If the owner or operator has not determined the root cause of the exceedance within 30 days of determining that the action level has been exceeded, the owner or operator must employ the appropriate real-time sampling techniques (
(2) If either the underlying primary or other contributing causes of the exceedance are deemed to be under the control of the owner or operator and subject to a regulation codified in 40 CFR part 63, except as provided in paragraph (c)(3) of this section, the owner or operator must take appropriate corrective action as expeditiously as possible to bring annual average fenceline concentrations back below the action level set forth in paragraph (c)(3) of this section and to prevent future exceedances from the same underlying cause(s).
(3) If the underlying primary or other contributing cause of the exceedance is under the control of the owner or operator but not subject to a regulation codified in 40 CFR part 63, as evidenced through the root cause analysis in paragraph (d)(1) of this section and supported by appropriate real-time sampling techniques consistent with paragraph (d)(1)(ii)(B) of this section, the owner or operator is not required to take corrective action under this subpart at any portion of the facility not subject to a regulation codified in 40 CFR part 63. However, the owner or operator must add additional monitoring locations in accordance with section 8.2.1.3 of EPA Method 325A in appendix A to this part or update their site-specific monitoring plan to add additional real-time monitors to account and correct for this near-field source of emissions not subject to a regulation codified in 40 CFR part 63 within 60 days of determining the underlying cause.
(4) The root cause analysis must be completed and initial corrective actions, if applicable, taken no later than 45 days after determining there is an exceedance of an action level.
(5) Except as noted in paragraph (d)(6) of this section, until the annual average Δc is below the action level again, following the completion of the initial corrective action, the owner or operator must conduct a new root cause analysis according to this paragraph (d), and if required, submit a corrective action plan under paragraph (e) of this section following any sampling period for which the Δc for the sampling period is greater than the action level in paragraph (c)(3) of this section.
(6) This paragraph applies when an owner or operator is required under paragraph (d)(3) of this section to update the site-specific monitoring plan to account for an additional near-field emission source. Until the annual average Δc is below the action level again, following implementation of the approved revision to the site-specific monitoring plan, the owner or operator must conduct a new root cause analysis according to this paragraph (d), and if required, submit a corrective action plan under paragraph (e) of this section following any sampling period for which the Δc for the sampling period is greater than the action level in paragraph (c)(3) of this section.
(e) An owner or operator must develop a corrective action plan if any of the conditions in paragraphs (e)(1) through (e)(3) of this section are met. The corrective action plan must describe the corrective action(s) completed to date, additional measures that the owner or operator proposes to employ to reduce annual average fenceline concentrations below the action level set forth in paragraph (c)(3) of this section, and a schedule for completion of these measures. The corrective action plan does not need to be approved by the Administrator. However, if upon review, the Administrator disagrees with the additional measures outlined in the plan, the owner or operator must revise and resubmit the plan within 7 calendar days of receiving comments from the Administrator.
(1) Except as noted in paragraph (e)(3) of this section, if upon completion of the root cause analysis and initial corrective actions required under paragraph (d) of the section, the Δc value for the next sampling period, for which the sampling start time begins after the completion of the initial corrective actions, is greater than the level specified in paragraph (c)(3) of this section. The corrective action plan must include the implementation of real-time sampling techniques to locate the primary and other contributing causes of the exceedance. The owner or operator must submit the corrective action plan to the Administrator within 60 days after receiving the analytical results indicating that the Δc value for the sampling period following the completion of the initial corrective action is greater than the level specified in paragraph (c)(3) of this section.
(2) The owner or operator must develop a corrective action plan if complete implementation of all corrective measures identified in the root cause analysis required by paragraph (e) of this section will require more than 45 days. The owner or operator must submit the corrective action plan to the Administrator no later than 60 days following the completion of the root cause analysis required in paragraph (d) of this section.
(3) The owner or operator must develop a corrective action plan if upon completion of the root cause analysis and following implementation of the approved revision to the site-specific monitoring plan required under paragraph (d)(3) of this section, the Δc value for the next sampling period, for which the sampling start time begins after implementation of the approved revision to the site-specific monitoring plan, is greater than the level specified in paragraph (c)(3) of this section. The corrective action plan must include the implementation of real-time sampling techniques to locate the primary and other contributing causes of the exceedance. The owner or operator must submit the corrective action plan to the Administrator within 60 days after receiving the analytical results indicating that the Δc value for the sampling period following the implementation of the approved revision to the site-specific monitoring plan is greater than the level specified in paragraph (c)(3) of this section.
(f) An owner or operator may request approval from the Administrator for a site-specific monitoring plan to account for offsite upwind sources or onsite sources not subject to a regulation
(1) The owner or operator must prepare and submit a site-specific monitoring plan and receive approval of the site-specific monitoring plan prior to using the near-field source alternative calculation for determining Δc provided in paragraph (f)(2) of this section. The site-specific monitoring plan shall include, at a minimum, the elements specified in paragraphs (f)(1)(i) through (v) of this section. The procedures in section 12 of Method 325A in appendix A to this part are not required, but may be used, if applicable, when determining near-field source contributions.
(i) Identification of the near-field source or sources. For onsite sources, specify that the onsite source is not subject to a regulation codified in 40 CFR part 63 and identify any federal regulation or federally enforceable permit condition the source is subject to.
(ii) Identification of the fenceline monitoring locations impacted by the near-field source. If more than one near-field source is present, identify the near-field source or sources that are expected to contribute to the concentration at each monitoring location.
(iii) A description of (including sample calculations illustrating) the planned data reduction; treatment of invalid data and data below detection limits; and calculations to determine the near-field source concentration contribution for each monitoring location.
(iv) A detailed description of the measurement technique, measurement location(s), the standard operating procedures, measurement frequency, recording frequency, measurement detection limit, and data quality indicators to ensure accuracy, precision, and validity of the data. If you are accounting for on-site sources, you must use a real-time sampling technique (
(v) A detailed description of how data will be handled during periods of calm wind conditions (
(2) When an approved site-specific monitoring plan is used, the owner or operator shall determine Δc for comparison with action level according to paragraph (c) of this section. When determining the sample results for use in the Δc calculation, the concentration for any monitor that has been corrected using an approved site-specific monitoring plan will be corrected according to the procedures specified in paragraphs (f)(2)(i) and (ii) of this section.
(i) For each monitoring location corrected using the site-specific monitoring plan, the corrected fenceline concentration at that monitoring station will be equal to the fenceline concentration measured with Methods 325A and 325B in appendix A to this part minus the near-field source contributing concentration at the measurement location determined using the additional measurements and calculation procedures included in the approved site-specific monitoring plan.
(ii) If the fenceline concentration at the monitoring station is below the method detection limit for Methods 325A and 325B in appendix A to this part, no near-field source contribution can be subtracted from that monitoring station for that sampling period.
(3) The site-specific monitoring plan shall be submitted and approved as described in paragraphs (f)(3)(i) through (iv) of this section.
(i) The site-specific monitoring plan must be submitted to the Administrator for approval.
(ii) The site-specific monitoring plan shall also be submitted to the following address: U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Sector Policies and Programs Division, U.S. EPA Mailroom (D243-02), Attention: Metals and Inorganic Chemicals Group, 109 T.W. Alexander Drive, Research Triangle Park, NC 27711. Electronic copies in lieu of hard copies also may be submitted to
(iii) The Administrator shall approve or disapprove the plan in 120 days. The plan shall be considered approved if the Administrator either approves the plan in writing or fails to disapprove the plan in writing. The 120-day period shall begin when the Administrator confirms receipt of a complete site-specific monitoring plan.
(iv) If the Administrator finds any deficiencies in the site-specific monitoring plan and disapproves the plan in writing, the owner or operator may revise and resubmit the site-specific monitoring plan following the requirements in paragraphs (f)(3)(i) and (ii) of this section. The 120-day period starts over with the resubmission of the revised monitoring plan. The Administrator may indicate in writing that a submitted plan is incomplete and specify the information necessary for completeness.
(4) The approval by the Administrator of a site-specific monitoring plan will be based on the completeness, accuracy and reasonableness of the request for a site-specific monitoring plan. Factors that the Administrator will consider in reviewing the request for a site-specific monitoring plan include, but are not limited to, those described in paragraphs (f)(4)(i) through (v) of this section.
(i) The identification of the near-field source or sources and evidence of how the sources impact the fenceline concentration.
(ii) The location(s) selected for additional monitoring to determine the near-field source concentration contribution.
(iii) The identification of the fenceline monitoring locations impacted by the near-field source or sources.
(iv) The appropriateness of the planned data reduction and calculations to determine the near-field source concentration contribution for each monitoring location, including the handling of invalid data, data below the detection limit, and data during calm periods.
(v) The adequacy of the description of and the rationale for the measurement technique, measurement location(s), the standard operating procedure, the measurement and recording frequency, measurement detection limit, and data quality indicators proposed to ensure accuracy, precision, and validity of the data.
(g) The owner or operator shall comply with the applicable recordkeeping and reporting requirements in § 63.311.
(h) As outlined in § 63.7(f), the owner or operator may submit a request for an alternative test method. At a minimum, the request must follow the requirements outlined in paragraphs (h)(1) through (7) of this section.
(1) The alternative method may be used in lieu of all samplers or a partial number of the passive samplers required in Method 325A in appendix A to this part.
(2) The alternative method must be validated according to Method 301 in appendix A of this part or contain performance-based procedures and indicators to ensure self-validation.
(3) The method detection limit must nominally be at least one-third of the action level. The alternate test method must describe the procedures used to provide field verification of the detection limit in the sample matrix being measured.
(4) If the alternative test method will be used to replace some or all passive samplers required under paragraph (a) of this section, the spatial coverage must be equal to or better than the spatial coverage provided in Method 325A in appendix A to this part.
(i) For path average concentration open-path instruments, the physical path length of the measurement shall be no more than a passive sample footprint (the spacing that would be provided by the sorbent traps when following Method 325A). For example, if Method 325A requires spacing monitors A and B 610 meters (2000 feet) apart, then the physical path length limit for the measurement at that portion of the fenceline shall be no more than 610 meters (2000 feet).
(ii) For range resolved open-path instrument or approach, the instrument or approach must be able to resolve an average concentration over each passive sampler footprint within the path length of the instrument.
(iii) The extra samplers required in sections 8.2.1.3 of Method 325A may be omitted when they fall within the path length of an open-path instrument.
(5) At a minimum, non-integrating alternative test methods must provide a minimum of one cycle of operation (sampling, analyzing, and data recording) for each successive 15-minute period.
(6) For alternative test methods capable of real time measurements (less than a 5-minute sampling and analysis cycle), the alternative test method may allow for elimination of data points corresponding to outside emission sources for purpose of calculation of the high point for the two-week average. The alternative test method approach must have wind speed, direction and stability class of the same time resolution and within the footprint of the instrument.
(7) For purposes of averaging data points to determine the Δc for the 14-day average high sample result, all results measured under the method detection limit must use the method detection limit. For purposes of averaging data points for the 14-day average low sample result, all results measured under the method detection limit must use zero.
This subpart establishes national emission standards for hazardous air pollutants (NESHAP) for pushing, soaking, quenching, battery stacks, heat and/or nonrecovery (HNR) heat recovery steam generator (HRSG) main stacks, and HNR HRSG bypass/waste heat stacks at facilities that produce coke in coke oven batteries and facilities that recover heat from coke oven gas. This subpart also establishes requirements to demonstrate initial and continuous compliance with all applicable emission limitations, work practice standards, and operation and maintenance requirements in this subpart.
(a) This subpart applies to each new or existing affected source at your coke plant. The affected source is each coke oven battery and units that recover heat from coke oven gas from the coke batteries.
(b) This subpart covers emissions from pushing, soaking, quenching, by-product battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks from each affected source, as applicable to the coke oven facility.
(c) An affected source at your coke plant is existing if you commenced construction or reconstruction of the affected source before July 3, 2001.
(d) An affected source at your coke plant is new if you commenced construction or reconstruction of the affected source on or after July 3, 2001. An affected source is reconstructed if it meets the definition of “reconstruction” in § 63.2. This paragraph (d) does not apply to the emission limitations listed in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively.
(e) An affected source at your coke plant is existing for the emissions limitations listed in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively if you commenced construction or reconstruction of the affected source before August 16, 2023.
(f) An affected source at your coke plant is new for the emissions limitations listed in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively if you commenced construction or reconstruction of the affected source on or after August 16, 2023.
(a) If you have an existing affected source, you must comply with each emission limitation, work practice standard, and operation and maintenance requirement in this subpart that applies to you no later than April 14, 2006. This paragraph does not apply to the emission limitations listed in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively.
(b) If you have a new affected source and its initial startup date is on or before April 14, 2003, you must comply with each emission limitation, work practice standard, and operation and maintenance requirement in this subpart that applies to you by April 14, 2003. This paragraph does not apply to the emission limitations listed in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively.
(c) If you have a new affected source and its initial startup date is after April 14, 2003, you must comply with each emission limitation, work practice standard, and operation and maintenance requirement in this subpart that applies to you upon initial startup. This paragraph does not apply to the emission limitations listed in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively.
(d) With regard to the §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) emission limitations for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks, respectively:
(1) If you have an existing affected source or a new or reconstructed affected source for which construction or reconstruction commenced on or before August 16, 2023, you must be in
(2) If you have a new or reconstructed affected source for which construction or reconstruction commenced after August 16, 2023, you must be in compliance no later than January 5, 2026 or upon startup, whichever is later.
(e) With regard to the § 63.7299 opacity limitations for HNR HRSG bypass/waste heat stacks:
(1) If you have an existing affected source or a new or reconstructed affected source for which construction or reconstruction commenced on or before August 16, 2023, you must be in compliance no later than July 7, 2025.
(2) If you have a new or reconstructed affected source for which construction or reconstruction commenced after August 16, 2023, you must be in compliance no later than July 7, 2025, or upon initial startup, whichever is later.
(f) You must meet the notification and schedule requirements in § 63.7340. Several of these notifications must be submitted before the compliance date for your affected source.
(a) You must not discharge to the atmosphere emissions of particulate matter from a control device applied to pushing emissions from a new or existing coke oven battery that exceed the applicable limit in paragraphs (a)(1) through (4) of this section:
(1) 0.01 grain per dry standard cubic foot (gr/dscf) if a cokeside shed is used to capture emissions;
(2) 0.02 pound per ton (lb/ton) of coke if a moveable hood vented to a stationary control device is used to capture emissions;
(3) If a mobile scrubber car that does not capture emissions during travel is used:
(i) 0.03 lb/ton of coke for a control device applied to pushing emissions from a short battery, or
(ii) 0.01 lb/ton of coke for a control device applied to pushing emissions from a tall battery; and
(4) 0.04 lb/ton of coke if a mobile control device that captures emissions during travel is used.
(b) You must not discharge to the atmosphere emissions of mercury from a control device applied to pushing emissions from a new coke oven battery that exceeds 5.1E-07 lb/ton coke or existing coke oven battery that exceeds 8.9E-07 lb/ton coke.
(c) You must not discharge to the atmosphere emissions of total acid gases from a control device applied to pushing emissions from a new coke oven battery that exceeds 5.3E-04 lb/ton coke or existing coke oven battery that exceeds 0.013 lb/ton coke.
(d) You must not discharge to the atmosphere emissions of hydrogen cyanide from a control device applied to pushing emissions from a new coke oven battery that exceeds 3.8E-05 lb/ton coke or existing coke oven battery that exceeds 0.0015 lb/ton coke.
(e) You must not discharge to the atmosphere emissions of total polycyclic aromatic hydrocarbons (PAH) from a control device applied to pushing emissions from a new coke oven battery that exceeds 1.4E-05 lb/ton coke or existing coke oven battery that exceeds 4.0E-04 lb/ton coke.
(f) You must meet each operating limit in paragraphs (f)(1) through (4) of this section that applies to you for a new or existing coke oven battery.
(1) For each venturi scrubber applied to pushing emissions, you must maintain the daily average pressure drop and scrubber water flow rate at or above the minimum levels established during the initial performance test.
(2) For each hot water scrubber applied to pushing emissions, you must maintain the daily average water pressure and water temperature at or above the minimum levels established during the initial performance test.
(3) For each capture system applied to pushing emissions, you must maintain the daily average volumetric flow rate at the inlet of the control device at or above the minimum level established during the initial performance test; or
(i) For each capture system that uses an electric motor to drive the fan, you must maintain the daily average fan motor amperes at or above the minimum level established during the initial performance test; and
(ii) For each capture system that does not use a fan driven by an electric motor, you must maintain the daily average static pressure at the inlet to the control device at an equal or greater vacuum than the level established during the initial performance test or maintain the daily average fan revolutions per minute (RPM) at or above the minimum level established during the initial performance test.
(4) For each multicyclone, you must maintain the daily average pressure drop at or below the minimum level established during the initial performance test.
(a) You must meet the requirements in paragraphs (a)(1) and (2) of this section for each new and existing nonrecovery coke oven battery.
(1) You must visually inspect each oven prior to pushing by opening the door damper and observing the bed of coke.
(2) Do not push the oven unless the visual inspection indicates that there is no smoke in the open space above the coke bed and that there is an unobstructed view of the door on the opposite side of the oven.
(b) As provided in § 63.6(g), you may request to use an alternative to the work practice standard in paragraph (a) of this section.
You must not discharge to the atmosphere any emissions from any battery stack at a new or existing by-product coke oven battery that exhibit an opacity greater than the applicable limits in paragraphs (a) and (b) of this section and emissions greater than the applicable limits in paragraphs (c) through (f) of this section.
(a) Daily average of 15 percent opacity for a battery on a normal coking cycle.
(b) Daily average of 20 percent opacity for a battery on batterywide extended coking.
(c) Emissions of particulate matter from a new by-product coke oven battery stack that exceeds 0.013 gr/dscf at 10 percent oxygen or existing by-product coke oven battery stack that exceeds 0.13 gr/dscf at 10 percent oxygen.
(d) Emissions of mercury from a new by-product coke oven battery stack that exceeds 7.1E-06 lb/ton coke or existing by-product coke oven battery stack that exceeds 4.5E-05 lb/ton coke.
(e) Emissions of total acid gases from a new by-product coke oven battery stack that exceeds 0.013 lb/ton coke or existing by-product coke oven battery stack that exceeds 0.16 lb/ton coke.
(f) Emissions of hydrogen cyanide from a new by-product coke oven battery stack that exceeds 7.4E-04 lb/ton coke or existing by-product coke oven battery stack that exceeds 0.032 lb/ton coke.
You must not discharge to the atmosphere any emissions from any HNR HRSG main stack at a new or existing HNR coke oven battery that exhibit emissions greater than the applicable limits in paragraphs (a) through (d) of this section.
(a) Emissions of particulate matter from any HNR HRSG main stack at a new HNR coke oven battery that exceeds 8.8E-04 gr/dscf at 10 percent oxygen or any HNR HRSG main stack at an existing HNR coke oven battery that exceeds 0.0049 gr/dscf at 10 percent oxygen.
(b) Emissions of mercury from any HNR HRSG main stack at a new HNR coke oven battery that exceeds 1.5E-06 gr/dscf at 10 percent oxygen or any HNR HRSG main stack at an existing HNR coke oven battery that exceeds 3.0E-06 gr/dscf at 10 percent oxygen.
(c) Emissions of total acid gases from any HNR HRSG main stack at a new HNR coke oven battery that exceeds 0.0034 gr/dscf at 10 percent oxygen or any HNR HRSG main stack at an existing HNR coke oven battery that exceeds 0.049 gr/dscf at 10 percent oxygen.
(d) Emissions of total PAHs from any HNR HRSG main stack at a new HNR coke oven battery that exceeds 4.7E-07 gr/dscf at 10 percent oxygen or any HRSG main stack at existing HNR coke oven battery that exceeds 4.8E-07 gr/dscf at 10 percent oxygen.
You must not discharge to the atmosphere any emissions from any HNR HRSG bypass/waste heat stack at a new or existing HNR coke oven battery that exhibit emissions greater than the applicable limits in paragraphs (a) through (e) of this section.
(a) Emissions of particulate matter from any HNR HRSG bypass/waste heat stack at a new HNR coke oven battery that exceeds 0.022 gr/dscf at 10 percent oxygen or any HNR HRSG bypass/waste heat stack at an existing HNR coke battery that exceeds 0.032 gr/dscf at 10 percent oxygen.
(b) Emissions of mercury from any HNR HRSG bypass/waste heat stack at a new HNR coke oven battery that exceeds 8.6E-06 gr/dscf at 10 percent oxygen or any HNR HRSG bypass/waste heat stack at an existing HNR coke oven battery that exceeds 1.2E-05 gr/dscf at 10 percent oxygen.
(c) Emissions of total acid gases from any HNR HRSG bypass/waste heat stack at a new HNR coke oven battery that exceeds 0.12 gr/dscf at 10 percent oxygen or any HNR HRSG bypass/waste heat stack at an existing HNR coke battery that exceeds 0.095 gr/dscf at 10 percent oxygen.
(d) Emissions of total PAHs from any HNR HRSG bypass/waste heat stack at a new or existing HNR coke oven battery that exceeds 2.7E-06 gr/dscf at 10 percent oxygen.
(e) Emissions of formaldehyde from any HNR HRSG bypass/waste heat stack at a new HNR coke oven battery that exceeds 1.8E-05 gr/dscf at 10 percent oxygen or any HNR HRSG bypass/waste heat stack at an existing HNR coke oven battery that exceeds 0.0012 gr/dscf at 10 percent oxygen.
The owner or operator shall observe the exhaust stack of each bypass or waste heat stacks once each week that exhaust is emitted through each stack continuously for more than an hour. The observation shall be made when exhaust is being emitted through the bypass or waste heat stack to determine if opacity, as a 6-minute average measured according to EPA Method 9 in appendix A-4 to 40 CFR part 60, exceeds 20 percent opacity. The owner or operator shall record the results of each observation. If a bypass event does not occur during a week or does not exceed one hour in duration, then no measurement is required for that week. If exhaust is emitted through any bypass or waste heat stack continuously for more than an hour during a week and no opacity measurement has been performed, the owner or operator shall record in the operating record the reason why conditions did not permit an opacity observation. If opacity greater than 20 percent opacity is observed during any weekly measurement, the owner or operator must:
(a) Take corrective action to reduce the emissions contributing to the opacity;
(b) Record the cause of opacity exceeding 20 percent and the corrective action taken; and
(c) Report opacity exceedances in any HNR HRSG bypass or HNR waste heat stacks in the quarterly semiannual compliance report required by § 63.7341.
(a) As required by § 63.7310(a) you must always operate and maintain your affected source, including air pollution control and monitoring equipment, in a manner consistent with good air pollution control practices for minimizing emissions at least to the levels required by this subpart.
(c) You must prepare and operate at all times according to a written operation and maintenance plan for each capture system and control device applied to pushing emissions from a new or existing coke oven battery. Each plan must address at a minimum the elements in paragraphs (c)(1) through (4) of this section.
(1) Monthly inspections of the equipment that are important to the performance of the total capture system (
(2) Preventative maintenance for each control device, including a preventative maintenance schedule that is consistent with the manufacturer's instructions for routine and long-term maintenance.
(3) Corrective action for all baghouses applied to pushing emissions. In the event a bag leak detection system alarm is triggered, you must initiate corrective action to determine the cause of the alarm within 1 hour of the alarm, initiate corrective action to correct the cause of the problem within 24 hours of the alarm, and complete the corrective action as soon as practicable. Actions may include, but are not limited to:
(i) Inspecting the baghouse for air leaks, torn or broken bags or filter media, or any other condition that may cause an increase in emissions.
(ii) Sealing off defective bags or filter media.
(iii) Replacing defective bags or filter media or otherwise repairing the control device.
(iv) Sealing off a defective baghouse compartment.
(v) Cleaning the bag leak detection system probe, or otherwise repairing the bag leak detection system.
(vi) Shutting down the process producing the particulate emissions.
(4) Beginning January 5, 2026, you must identify and implement a set of site-specific good combustion practices for each battery. These good combustion practices should correspond to your standard operating procedures for maintaining the proper and efficient combustion within battery waste heat flues. Good combustion practices include, but are not limited to, the elements listed in paragraphs (c)(4)(i) through (v) of this section.
(i) Proper operating conditions for each battery (
(ii) Routine inspection and preventative maintenance and corresponding schedules of each battery.
(iii) Performance analyses of each battery.
(iv) Maintaining applicable operator logs.
(v) Maintaining applicable records to document compliance with each element.
(a) You must be in compliance with the emission limitations, work practice standards, and operation and maintenance requirements in this subpart at all times. At all times, you must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. The general duty to minimize emissions does not require further efforts to reduce emissions if levels required by the applicable standard have been achieved. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the source.
(b) During the period between the compliance date specified for your affected source in § 63.7283 and the date upon which continuous monitoring systems have been installed and certified and any applicable operating limits have been set, you must maintain a log detailing the operation and maintenance of the process and emissions control equipment.
(a) As required in § 63.7(a)(2), you must conduct a performance test to demonstrate compliance with each limit in:
(1) Section 63.7290(a) through (e) for emissions of particulate matter, mercury, total acid gases, HCN, and total PAH from a control device applied to pushing emissions that applies to you within 180 calendar days after the compliance date that is specified in § 63.7283.
(2) Section 63.7296(c) through (f) for emissions of particulate matter, mercury, total acid gases, and HCN from a battery stack that applies to you within 180 calendar days after the compliance date that is specified in § 63.7283.
(3) Section 63.7297(a) through (d) for emissions of mercury, particulate matter, total acid gases, and total PAH from a HNR HRSG main stack that applies to you within 180 calendar days after the compliance date that is specified in § 63.7283.
(4) Section 63.7298(a) through (e) for emissions of mercury, particulate matter, total acid gases, total PAH, and formaldehyde from a HNR HRSG bypass/waste heat stack that applies to you within 180 calendar days after the compliance date that is specified in § 63.7283.
(a) For each control device subject to an emission limit for particulate matter in § 63.7290(a), you must conduct subsequent performance tests no less frequently than once every 5 years or at the beginning of each term of your title V operating permit, whichever is less.
(b) For each source subject to emission limits in §§ 63.7290(b) through (d), 63.7296(c) through (f), 63.7297(a) through (d), and 63.7298(a) through (e) for capture systems and control devices applied to pushing emissions, battery stacks, HNR HRSG main stacks, and HNR HRSG bypass/waste heat stacks sources, respectively, you must conduct subsequent performance tests once every five years.
(a) You must conduct each performance test that applies to your affected source based on representative performance (
(b) To determine compliance with the emission limit for particulate matter from a control device applied to pushing emissions where a cokeside shed is the capture system, battery stack, HNR HRSG main stack, and HNR HRSG bypass/waste heat stack, follow the test methods and procedures in paragraphs (b)(1) and (2) of this section.
(1) Determine the concentration of particulate matter according to the following test methods in appendices A-1 through A-3 to 40 CFR part 60.
(i) Method 1 to select sampling port locations and the number of traverse points. Sampling sites must be located at the outlet of the control device and prior to any releases to the atmosphere.
(ii) Method 2, 2F, or 2G to determine the volumetric flow rate of the stack gas.
(iii) Method 3, 3A, or 3B to determine the dry molecular weight of the stack gas. You may also use as an alternative to Method 3B, the manual method (but not instrumental procedures) for measuring the oxygen, carbon dioxide, and carbon monoxide content of exhaust gas, ANSI/ASME PTC 19.10-1981 (incorporated by reference, see § 63.14).
(iv) Method 4 to determine the moisture content of the stack gas.
(v) Method 5 or 5D, as applicable, to determine the concentration of filterable particulate matter in the stack gas.
(2) Collect a minimum sample volume of 30 dry standard cubic feet of gas during each test run. Three valid test runs are needed to comprise a performance test. During each particulate matter test run to meet the emission limitations in § 63.7290, sample only during periods of actual pushing when the capture system fan and control device are engaged. For capture systems and control devices applied to pushing emissions each run must start at the beginning of a push and finish at the end of a push (
(3) Determine the total combined weight in tons of coke pushed during the duration of each test run according to the procedures in your source test plan for calculating coke yield from the quantity of coal charged to an individual oven.
(4) Compute the process-weighted mass emissions (E
(c) To determine compliance with the emission limit for mercury from a control device applied to pushing emissions where a cokeside shed is the capture system, battery stack, HNR HRSG main stack, and HNR HRSG bypass/waste heat stack, follow the test methods and procedures in paragraphs (c)(1) and (2) of this section. To determine compliance with a process-weighted mass rate of mercury (lb/ton of coke) from a control device applied to pushing emissions and battery stack, follow the test methods and procedures in paragraphs (c)(1) through (4) of this section.
(1) Determine the concentration of mercury according to the following test methods.
(i) The methods specified in sections (b)(1)(i) through (iv) of this section.
(ii) Method 29 in appendix A-8 to 40 CFR part 60, to determine the concentration of mercury in the stack gas. The voluntary consensus standard ASTM D6784-16 (incorporated by reference, see § 63.14) is an acceptable alternative to EPA Method 29 (portion for mercury only) as a method for measuring mercury, note: applies to concentrations approximately 0.5—100 μg/Nm3.
(2) Collect a minimum sample volume of 70 dry standard cubic feet of gas during each mercury test run. Three valid test runs are needed to comprise a performance test. During each mercury test run to meet the emission limitations in § 63.7290, sample only during periods of actual pushing when the capture system fan and control device are engaged. For capture systems and control devices applied to pushing emissions each run must start at the beginning of a push and finish at the end of a push (
(3) Determine the total combined weight in tons of coke pushed during the duration of each test run according to the procedures in your source test plan for calculating coke yield from the quantity of coal charged to an individual oven.
(4) Compute the process-weighted mass emissions (E
(d) To determine compliance with the emission limit for total acid gases from a HNR HRSG main stack and HNR HRSG bypass/waste heat stack, follow the test methods and procedures in paragraphs (d)(1) and (2) of this section. To determine compliance with a process-weighted mass rate of total acid gases (lb/ton of coke) from a control device applied to pushing emissions and battery stack, follow the test methods and procedures in paragraphs (d)(1) through (4) of this section.
(1) Determine the concentration of total acid gases according to the following test methods.
(i) The methods specified in sections (b)(1)(i) through (iv) of this section.
(ii) Methods 26 or 26A in appendix A-8 to 40 CFR part 60, or Method 320 in appendix A to this part, to determine the concentration of total acid gases in the stack gas. The voluntary consensus standard ASTM D6348-12 (Reapproved 2020) (incorporated by reference, see § 63.14) is an acceptable alternative to Method 320 at this time with caveats requiring inclusion of selected annexes to the standard as mandatory. When using ASTM D6348-12 (Reapproved 2020), the following conditions must be met:
(A) The test plan preparation and implementation in the Annexes to ASTM D6348-12 (Reapproved 2020), Annexes A1 through A8 are mandatory; and
(B) In ASTM D6348-12 (Reapproved2020) Annex A5 (Analyte Spiking Technique), the percent (%) R must be determined for each target analyte (Equation A5.5).
(C) In order for the test data to be acceptable for a compound, % R must be greater than or equal to 70% and less than or equal to 130%. If the % R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the test must be repeated for that analyte
(2) Collect a minimum sample volume of 35 dry standard cubic feet of gas during each test run for Method 26 and 26A in appendix A-8 to 40 CFR part 60. For Method 320 in appendix A to this part and ASTM D6348-12 (Reapproved 2020) (incorporated by reference, see § 63.14), each test run must be a minimum of one hour in duration. Three valid test runs are needed to comprise a performance test. During each total acid gases test run to meet the emission limitations in § 63.7290, sample only during periods of pushing when the capture system fan and control device are engaged. For capture systems and control devices applied to pushing emissions each run must start at the beginning of a push and finish at the end of a push (
(3) Determine the total combined weight in tons of coke pushed during the duration of each test run according to the procedures in your source test plan for calculating coke yield from the quantity of coal charged to an individual oven.
(4) Compute the process-weighted mass emissions (E
(e) To determine compliance with a process-weighted mass rate of hydrogen cyanide (lb/ton of coke) from a control device applied to pushing emissions and battery stack, follow the test methods and procedures in paragraphs (e)(1) through (4) of this section.
(1) Determine the concentration of hydrogen cyanide according to the following test methods.
(i) The methods specified in sections (b)(1)(i) through (iv) of this section.
(ii) Method 320 in appendix A to this part, to determine the concentration of hydrogen cyanide in the stack gas. The voluntary consensus standard ASTM D6348-12 (Reapproved 2020) (incorporated by reference, see § 63.14) is an acceptable alternative to Method 320 at this time with caveats requiring inclusion of selected annexes to the standard as mandatory. When using ASTM D6348-12 (Reapproved 2020), the following conditions must be met:
(A) The test plan preparation and implementation in the Annexes to ASTM D6348-12 (Reapproved 2020), Annexes A1 through A8 are mandatory; and
(B) In ASTM D6348-12 (Reapproved 2020) Annex A5 (Analyte Spiking Technique), the percent (%) R must be determined for each target analyte (Equation A5.5).
(C) In order for the test data to be acceptable for a compound, % R must be greater than or equal to 70% and less than or equal to 130%. If the % R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the test must be repeated for that analyte (
(2) Collect a minimum of eight spectra for each of six runs (or hours) evenly spaced over the test period for Method 320 in appendix A to this part or alternatively ASTM D6348-12 (Reapproved 2020) (incorporated by reference, see § 63.14). Three valid test runs are needed to comprise a performance test. During each hydrogen cyanide test run to meet the emission limitations in § 63.7290, sample only during periods of actual pushing when the capture system fan and control device are engaged. For capture systems and control devices applied to pushing emissions each run must start at the beginning of a push and finish at the end of a push (
(3) Determine the total combined weight in tons of coke pushed during the duration of each test run according to the procedures in your source test plan for calculating coke yield from the quantity of coal charged to an individual oven.
(4) Compute the process-weighted mass emissions (E
(f) To determine compliance with the emission limit for total PAH from a HNR HRSG main stack and HNR HRSG bypass/waste heat stack, follow the test methods and procedures in paragraphs (f)(1) and (2) of this section. To determine compliance with a process-weighted mass rate of total PAH (lb/ton of coke) from a control device applied to pushing emissions, follow the test methods and procedures in paragraphs (f)(1) through (4) of this section.
(1) Determine the concentration of total PAH, the sum of 17 PAH compounds listed at § 63.7290(e), according to the following test methods.
(i) The methods specified in sections (b)(1)(i) through (iv) of this section.
(ii) Method 23 in appendix A-7 to 40 CFR part 60, to determine the concentration of total PAH in the stack gas.
(2) Collect a minimum sample volume of 105 dry standard cubic feet of gas during each test run for total PAH. Three valid test runs are needed to comprise a performance test. During each total PAH test run to meet the emission limitations in § 63.7290, sample only during periods of actual pushing when the capture system fan and control device are engaged. For capture systems and control devices applied to pushing emissions each run must start at the beginning of a push
(3) Determine the total combined weight in tons of coke pushed during the duration of each test run according to the procedures in your source test plan for calculating coke yield from the quantity of coal charged to an individual oven.
(4) Compute the process-weighted mass emissions (E
(g) To determine compliance with the emission limit for formaldehyde from a HNR HRSG bypass/waste heat stack, follow the test methods and procedures in paragraphs (h)(1) and (2) of this section.
(1) Determine the concentration of formaldehyde according to the following test methods.
(i) The methods specified in sections (b)(1)(i) through (iv) of this section.
(ii) Method 316 or Method 320 in appendix A to this part, to determine the concentration of formaldehyde in the stack gas. The voluntary consensus standard ASTM D6348-12 (Reapproved 2020) (incorporated by reference, see § 63.14) is an acceptable alternative to Method 320 at this time with caveats requiring inclusion of selected annexes to the standard as mandatory. When using ASTM D6348-12 (Reapproved 2020), the following conditions must be met:
(A) The test plan preparation and implementation in the Annexes to ASTM D6348-12 (Reapproved 2020), Annexes A1 through A8 are mandatory; and
(B) In ASTM D6348-12 (Reapproved 2020) Annex A5 (Analyte Spiking Technique), the percent (%) R must be determined for each target analyte (Equation A5.5).
(C) In order for the test data to be acceptable for a compound, % R must be greater than or equal to 70% and less than or equal to 130%. If the % R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the test must be repeated for that analyte (
(2) Sample time should ensure that minimum quantification levels have been met under the methods used during each test run, for Method 320 in appendix A to this part or ASTM D6348-12 (Reapproved 2020) (incorporated by reference, see § 63.14), each test run must be at least one hour in duration. Three valid test runs are needed to comprise a performance test.
(c) * * *
(1) If you elect the operating limit in § 63.7290(f)(3) for volumetric flow rate, measure and record the total volumetric flow rate at the inlet of the control device during each push sampled for each particulate matter test run. Your operating limit is the lowest volumetric flow rate recorded during any of the three runs that meet the emission limit.
(2) If you elect the operating limit in § 63.7290(f)(3)(i) for fan motor amperes, measure and record the fan motor amperes during each push sampled for each particulate matter test run. Your operating limit is the lowest fan motor amperes recorded during any of the three runs that meet the emission limit.
(3) If you elect the operating limit in § 63.7290(f)(3)(ii) for static pressure or fan RPM, measure and record the static pressure at the inlet of the control device or fan RPM during each push sampled for each particulate matter test run. Your operating limit for static pressure is the minimum vacuum recorded during any of the three runs that meets the emission limit. Your operating limit for fan RPM is the lowest fan RPM recorded during any of the three runs that meets the emission limit.
(a) You must conduct each performance test that applies to your affected source based on representative performance (
(a) If you elect the TDS limit for quench water in § 63.7295(a)(1)(i), you must conduct each performance test that applies to your affected source based on representative performance (
(a) For each coke oven battery subject to the emission limits from a control device applied to pushing emissions, you have demonstrated initial compliance if you meet the requirements in paragraphs (a)(1) through (9) of this section that apply to you.
(1) The concentration of particulate matter, measured in accordance with the performance test procedures in § 63.7322(b)(1) and (2), did not exceed 0.01 gr/dscf for a control device where a cokeside shed is used to capture pushing emissions or the process-weighted mass rate of particulate matter (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(b)(1) through (4), did not exceed:
(i) 0.02 lb/ton of coke if a moveable hood vented to a stationary control device is used to capture emissions;
(ii) If a mobile scrubber car that does not capture emissions during travel is used, 0.03 lb/ton of coke from a control device applied to pushing emissions from a short coke oven battery or 0.01 lb/ton of coke from a control device applied to pushing emissions from a tall coke oven battery; and
(iii) 0.04 lb/ton of coke if a mobile control device that captures emissions during travel is used.
(2) The process-weighted mass rate of mercury (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(c)(1) through (4), did not exceed 3.4E-07 lb/ton coke for pushing emissions from a new coke oven battery or 8.9E-07 lb/ton coke for pushing emissions from an existing coke oven battery.
(3) The process-weighted mass rate of total acid gases, the sum of hydrochloric acid and hydrofluoric acid (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(d)(1) through (4), did not exceed 5.1E-04 lb/ton coke for pushing emissions from a new coke oven battery or 0.0052 lb/ton coke for pushing emissions from an existing coke oven battery.
(4) The process-weighted mass rate of hydrogen cyanide (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(e)(1) through (4), did not exceed 3.8E-05 lb/ton coke for pushing emissions from a new coke oven battery or 0.0011 lb/ton coke for pushing emissions from an existing coke oven battery.
(5) The process-weighted mass rate of total PAH (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(f)(1) through (4), did not exceed 1.4E-05 lb/ton coke for pushing emissions from a new coke oven battery or 3.4E-04 lb/ton coke for pushing emissions from an existing coke oven battery.
(6) For each venturi scrubber applied to pushing emissions, you have established appropriate site-specific operating limits and have a record of the pressure drop and scrubber water flow rate measured during the performance test in accordance with § 63.7323(a).
(7) For each hot water scrubber applied to pushing emissions, you have established appropriate site-specific operating limits and have a record of the water pressure and temperature measured during the performance test in accordance with § 63.7323(b).
(8) For each capture system applied to pushing emissions, you have established an appropriate site-specific operating limit, and:
(i) If you elect the operating limit in § 63.7290(f)(3) for volumetric flow rate, you have a record of the total volumetric flow rate at the inlet of the control device measured during the performance test in accordance with § 63.7323(c)(1); or
(ii) If you elect the operating limit in § 63.7290(f)(3)(i) for fan motor amperes, you have a record of the fan motor amperes during the performance test in accordance with § 63.7323(c)(2); or
(iii) If you elect the operating limit in § 63.7290(f)(3)(ii) for static pressure or fan RPM, you have a record of the static pressure at the inlet of the control device or fan RPM measured during the performance test in accordance with § 63.7323(c)(3).
(9) For each multicyclone applied to pushing emissions, you have established an appropriate site-specific operating limit and have a record of the pressure drop measured during the performance test in accordance with § 63.7323(d).
(b) For each new or existing by-product coke oven battery subject to the emission limits in § 63.7296, you have demonstrated initial compliance if you meet the requirements in paragraphs (b)(1) through (5) of this section.
(1) The opacity limit for stacks in § 63.7296(a), you have demonstrated initial compliance if the daily average opacity, as measured according to the performance test procedures in § 63.7324(b), is no more than 15 percent for a battery on a normal coking cycle or 20 percent for a battery on batterywide extended coking.
(2) The concentration of particulate matter, measured in accordance with the performance test procedures in § 63.7322(b)(1) and (2), did not exceed 0.013 gr/dscf at 10 percent oxygen from a battery stack at a new by-product coke oven battery or 0.13 gr/dscf at 10 percent oxygen from a battery stack at an existing by-product coke oven battery.
(3) The process-weighted mass rate of mercury (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(c)(1) through (4), did not exceed 7.1E-06 lb/ton coke from a battery stack at a new by-product coke oven battery or 4.5E-05 lb/ton coke from a battery stack at an existing by-product coke oven battery.
(4) The process-weighted mass rate of total acid gases (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(d)(1) through (4), did not exceed 0.013 lb/ton coke from a battery stack at a new by-product coke oven battery or 0.16 lb/ton coke from a battery stack at an existing by-product coke oven battery.
(5) The process-weighted mass rate of hydrogen cyanide (lb/ton of coke), measured in accordance with the performance test procedures in § 63.7322(e)(1) through (4), did not exceed 7.4E-04 lb/ton coke from a battery stack at a new by-product coke oven battery or 0.032 lb/ton coke from a battery stack at an existing by-product coke oven battery.
(c) For each new or existing by-product coke oven battery subject to the TDS limit or constituent limits for quench water in § 63.7295(a)(1),
(1) You have demonstrated initial compliance with the TDS limit in § 63.7295(a)(1)(i) if the TDS concentration, as measured according to the performance test procedures in § 63.7325(a), does not exceed 1,100 mg/L.
(2) You have demonstrated initial compliance with the constituent limit in § 63.7295(a)(1)(ii) if:
(i) You have established a site-specific constituent limit according to the procedures in § 63.7325(b); and
(ii) The sum of the constituent concentrations, as measured according to the performance test procedures in § 63.7325(c), is less than or equal to the site-specific limit.
(d) For each new or existing HNR HRSG main stack subject to the emission limits in § 63.7297, you have demonstrated initial compliance if you meet the requirements in paragraphs (d)(1) through (4) of this section.
(1) The concentration of particulate matter, measured in accordance with the performance test procedures in § 63.7322(b)(1) and (2), did not exceed 8.8E-04 gr/dscf at 10 percent oxygen from a HNR HRSG main stack at a new HNR coke battery or 0.0049 gr/dscf at 10 percent oxygen at a HNR HRSG main stack at an existing HNR coke oven battery.
(2) The concentration of mercury, measured in accordance with the performance test procedures in § 63.7322(c)(1) and (2), did not exceed 1.5E-06 gr/dscf at 10 percent oxygen from a HNR HRSG main stack at a new HNR coke battery or 3.0E-06 gr/dscf at 10 percent oxygen at a HNR HRSG main stack at an existing HNR HRSG.
(3) The concentration of total acid gases, measured in accordance with the performance test procedures in § 63.7322(d)(1) and (2), did not exceed 3.4E-03 gr/dscf at 10 percent oxygen from a HNR HRSG main stack at a new coke oven battery or 4.9E-02 gr/dscf at 10 percent oxygen at a HNR HRSG main stack at an existing HNR coke oven battery.
(4) The concentration of total PAHs, measured in accordance with the performance test procedures in § 63.7322(f)(1) and (2), did not exceed 4.7E-07 gr/dscf at 10 percent oxygen from a HNR HRSG main stack at a new coke oven battery or 4.8E-07 gr/dscf at 10 percent oxygen at a HNR HRSG main stack at an existing HNR coke oven battery.
(e) For each HNR HRSG bypass/waste heat stack through which emissions are discharged from a new or existing coke oven battery subject to the emission limits in § 63.7298, you have demonstrated initial compliance if you meet the requirements in paragraphs (e)(1) through (5) of this section.
(1) The concentration of particulate matter, measured in accordance with the performance test procedures in § 63.7322(b)(1) and (2), did not exceed 0.022 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at a new HNR coke oven battery or 0.032 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at an existing HNR coke oven battery.
(2) The concentration of mercury, measured in accordance with the performance test procedures in § 63.7322(c)(1) and (2), did not exceed 8.6E-06 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at a new HNR coke oven battery or 1.2E-05 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at an existing HNR coke battery.
(3) The concentration of total acid gases, measured in accordance with the performance test procedures in § 63.7322(d)(1) and (2), did not exceed 0.12 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at a new HNR coke oven battery or 0.095 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at an existing HNR coke oven battery.
(4) The concentration of total PAHs, measured in accordance with the performance test procedures in § 63.7322(f)(1) and (2), did not exceed 2.7E-06 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at a new coke oven battery or existing HNR coke oven battery.
(5) The concentration of formaldehyde, measured in accordance with the performance test procedures in § 63.7322(g)(1) and (2), did not exceed 1.8E-05 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at a new HNR coke oven battery or 0.0012 gr/dscf at 10 percent oxygen from a HNR HRSG bypass/waste heat stack at an existing HNR coke oven battery.
(f) For each by-product coke oven battery stack subject to an opacity limit in § 63.7296(a) and each by-product coke oven battery subject to the requirements for quench water in § 63.7295(a)(1), you must submit a notification of compliance status containing the results of the COMS performance test for battery stacks and the quench water performance test (TDS or constituent limit) according to § 63.7340(e)(1). For each particulate matter, mercury, total acid gases, hydrogen cyanide, total PAHs, or formaldehyde emission limitation that applies to you, you must submit a notification of compliance status containing a summary of the results of the performance test according to § 63.7340(e)(2).
(c) For each nonrecovery coke oven battery subject to the work practice standards for fugitive pushing emissions in § 63.7293(a), you have demonstrated initial compliance if you certify in your notification of compliance status that you will meet each of the work practice requirements beginning no later than the compliance date that is specified in § 63.7283.
(b) * * *
(4) Ongoing operation and maintenance procedures in accordance with the general requirements of § 63.8(c)(1)(ii), (3), (4)(ii), (7), and (8);
(5) Ongoing data quality assurance procedures in accordance with the general requirements of §§ 63.8(d)(1) and (2) and 63.7342(b)(3); and
(6) Ongoing recordkeeping and reporting procedures in accordance the general requirements of § 63.10(c)(1) through (14) and (e)(1) and (2)(i).
(g) If you elect the operating limit in § 63.7290(f)(3) for a capture system applied to pushing emissions, you must install, operate, and maintain a device to measure the total volumetric flow rate at the inlet of the control device.
(h) If you elect the operating limit in § 63.7290(f)(3)(i) for a capture system applied to pushing emissions, you must install, operate, and maintain a device to measure the fan motor amperes.
(i) If you elect the operating limit in § 63.7290(f)(3)(ii) for a capture system applied to pushing emissions, you must install, operate and maintain a device to measure static pressure at the inlet of the control device or the fan RPM.
(a) For each control device applied to pushing emissions and subject to the emission limit in § 63.7290(a), you must demonstrate continuous compliance by meeting the requirements in paragraphs (a)(1) and (2) of this section:
(1) Maintaining emissions of particulate matter at or below the applicable limits in paragraphs § 63.7290(a)(1) through (4); and
(2) Conducting subsequent performance tests to demonstrate continuous compliance no less frequently than at the beginning of your title V operating permit or every 5 years, whichever is less.
(b) For each control device applied to pushing emissions and subject to the emission limits in § 63.7290(b) through (e), you must demonstrate continuous compliance by meeting the requirements in paragraphs (b)(1) through (5) of this section:
(1) Maintaining emissions of mercury at or below the applicable limits in § 63.7290(b);
(2) Maintaining emissions of total acid gases at or below the applicable limits in § 63.7290(c);
(3) Maintaining emissions of hydrogen cyanide at or below the applicable limits in § 63.7290(d);
(4) Maintaining emissions of total PAHs at or below the applicable limits in § 63.7290(e); and
(5) Conducting subsequent performance tests to demonstrate continuous compliance once every five years.
(c) For each venturi scrubber applied to pushing emissions and subject to the operating limits in § 63.7290(f)(1), you must demonstrate continuous compliance by meeting the requirements in paragraphs (c)(1) through (3) of this section.
(1) Maintaining the daily average pressure drop and scrubber water flow rate at levels no lower than those established during the initial or subsequent performance test.
(2) Operating and maintaining each CPMS according to § 63.7331(b) and recording all information needed to document conformance with these requirements.
(3) Collecting and reducing monitoring data for pressure drop and scrubber water flow rate according to § 63.7331(e)(1) through (3).
(d) For each hot water scrubber applied to pushing emissions and subject to the operating limits in § 63.7290(f)(2), you must demonstrate continuous compliance by meeting the requirements in paragraphs (d)(1) through (3) of this section.
(1) Maintaining the daily average water pressure and temperature at levels no lower than those established during the initial or subsequent performance test.
(2) Operating and maintaining each CPMS according to § 63.7331(b) and recording all information needed to document conformance with these requirements.
(3) Collecting and reducing monitoring data for water pressure and temperature according to § 63.7331(f).
(e) For each capture system applied to pushing emissions and subject to the operating limit in § 63.7290(f)(3), you must demonstrate continuous compliance by meeting the requirements in paragraph (e)(1), (2), or (3) of this section:
(1) If you elect the operating limit for volumetric flow rate in § 63.7290(f)(3):
(i) Maintaining the daily average volumetric flow rate at the inlet of the control device at or above the minimum level established during the initial or subsequent performance test; and
(ii) Checking the volumetric flow rate at least every 8 hours to verify the daily average is at or above the minimum level established during the initial or subsequent performance test and recording the results of each check.
(2) If you elect the operating limit for fan motor amperes in § 63.7290(f)(3)(i):
(i) Maintaining the daily average fan motor amperages at or above the minimum level established during the initial or subsequent performance test; and
(ii) Checking the fan motor amperage at least every 8 hours to verify the daily average is at or above the minimum level established during the initial or subsequent performance test and recording the results of each check.
(3) If you elect the operating limit for static pressure or fan RPM in § 63.7290(f)(3)(ii):
(i) Maintaining the daily average static pressure at the inlet to the control device at an equal or greater vacuum than established during the initial or subsequent performance test or the daily average fan RPM at or above the minimum level established during the initial or subsequent performance test; and
(ii) Checking the static pressure or fan RPM at least every 8 hours to verify the daily average static pressure at the inlet to the control device is at an equal or greater vacuum than established during the initial or subsequent performance test or the daily average fan RPM is at or above the minimum level established during the initial or subsequent performance test and recording the results of each check.
(f) Beginning on the first day compliance is required under § 63.7283, you must demonstrate continuous compliance for each by-product coke oven battery subject to the opacity limit for battery stacks in § 63.7296(a) by meeting the requirements in paragraphs (f)(1) and (2) of this section:
(1) Maintaining the daily average opacity at or below 15 percent for a battery on a normal coking cycle or 20 percent for a battery on batterywide extended coking; and
(2) Operating and maintaining a COMS and collecting and reducing the COMS data according to § 63.7331(j).
(g) For each battery stack subject to the emission limits in § 63.7296(c) through (f), you must demonstrate continuous compliance by meeting the requirements in paragraphs (g)(1) through (5) of this section:
(1) Maintaining emissions of particulate matter at or below the applicable limits in § 63.7296(c);
(2) Maintaining emissions of mercury at or below the applicable limits in § 63.7296(d);
(3) Maintaining emissions of total acid gases at or below the applicable limits in § 63.7296(e);
(4) Maintaining emissions of hydrogen cyanide at or below the applicable limits in § 63.7296(f); and
(5) Conducting subsequent performance tests to demonstrate continuous compliance once every five years.
(h) Beginning on the first day compliance is required under § 63.7283, you must demonstrate continuous compliance with the TDS limit for quenching in § 63.7295(a)(1)(i) by meeting the requirements in paragraphs (h)(1) and (2) of this section:
(1) Maintaining the TDS content of the water used to quench hot coke at 1,100 mg/L or less; and
(2) Determining the TDS content of the quench water at least weekly according to the requirements in § 63.7325(a) and recording the sample results.
(i) Beginning on the first day compliance is required under § 63.7283, you must demonstrate continuous compliance with the constituent limit for quenching in § 63.7295(a)(1)(ii) by meeting the requirements in paragraphs (i)(1) and (2) of this section:
(1) Maintaining the sum of the concentrations of benzene, benzo(a)pyrene, and naphthalene in the water used to quench hot coke at levels less than or equal to the site-specific limit approved by the permitting authority; and
(2) Determining the sum of the constituent concentrations at least monthly according to the requirements in § 63.7325(c) and recording the sample results.
(j) For each multicyclone applied to pushing emissions and subject to the operating limit in § 63.7290(f)(4), you must demonstrate compliance by meeting the requirements in paragraphs (j)(1) through (3) of this section.
(1) Maintaining the daily average pressure drop at a level at or below the level established during the initial or subsequent performance test.
(2) Operating and maintaining each CPMS according to § 63.7331(k) and recording all information needed to document conformance with these requirements.
(3) Collecting and reducing monitoring data for pressure drop according to § 63.7331(e)(1) through (3).
(k) For each HNR HRSG main stack subject to the emission limits in § 63.7297(a) through (d), you must demonstrate continuous compliance by
(1) Maintaining emissions of particulate matter at or below the applicable limits in § 63.7297(a);
(2) Maintaining emissions of mercury at or below the applicable limits in § 63.7297(b);
(3) Maintaining emissions of total acid gases at or below the applicable limits in § 63.7297(c);
(4) Maintaining emissions of total PAHs at or below the applicable limits in § 63.7297(d); and
(5) Conducting subsequent performance tests to demonstrate continuous compliance once every five years.
(l) For each HNR HRSG bypass/waste heat stack subject to the emission limits in § 63.7298(a) through (e), you must demonstrate continuous compliance by meeting the requirements in paragraphs (l)(1) through (6) of this section:
(1) Maintaining emissions of particulate matter at or below the applicable limits in § 63.7298(a);
(2) Maintaining emissions of mercury at or below the applicable limits in § 63.7298(b);
(3) Maintaining emissions of total acid gases at or below the applicable limits in § 63.7298(c);
(4) Maintaining emissions of total PAHs at or below the applicable limits in § 63.7298(d);
(5) Maintaining emissions of total formaldehyde at or below the applicable limits in § 63.7298(e); and
(6) Conducting subsequent performance tests to demonstrate continuous compliance once every five years.
(a) * * *
(3) Make all observations and calculations for opacity observations of fugitive pushing emissions in accordance with Method 9 in appendix A-4 to 40 CFR part 60 using a Method 9 certified observer unless you have an approved alternative procedure under paragraph (a)(7) of this section. Alternatively, ASTM D7520-16, (incorporated by reference, see § 63.14) may be used with the following conditions:
(i) During the digital camera opacity technique (DCOT) certification procedure outlined in section 9.2 of ASTM D7520-16 (incorporated by reference, see § 63.14), the owner or operator or the DCOT vendor must present the plumes in front of various backgrounds of color and contrast representing conditions anticipated during field use such as blue sky, trees, and mixed backgrounds (clouds and/or a sparse tree stand).
(ii) The owner or operator must also have standard operating procedures in place including daily or other frequency quality checks to ensure the equipment is within manufacturing specifications as outlined in section 8.1 of ASTM D7520-16 (incorporated by reference, see § 63.14).
(iii) The owner or operator must follow the recordkeeping procedures outlined in § 63.10(b)(1) for the DCOT certification, compliance report, data sheets, and all raw unaltered JPEGs used for opacity and certification determination.
(iv) The owner or operator or the DCOT vendor must have a minimum of four independent technology users apply the software to determine the visible opacity of the 300 certification plumes. For each set of 25 plumes, the user may not exceed 15 percent opacity of anyone reading and the average error must not exceed 7.5 percent opacity.
(v) Use of this approved alternative does not provide or imply a certification or validation of any vendor's hardware or software. The onus to maintain and verify the certification and/or training of the DCOT camera, software, and operator in accordance with ASTM D7520-16 (incorporated by reference, see § 63.14) and these requirements is on the facility, DCOT operator, and DCOT vendor.
(4) Record pushing opacity observations at 15-second intervals as required in section 2.4 of Method 9 in appendix A-4 to 40 CFR part 60. The requirement in section 2.4 of Method 9 for a minimum of 24 observations does not apply, and the data reduction requirements in section 2.5 of Method 9 do not apply. The requirement in § 63.6(h)(5)(ii)(B) for obtaining at least 3 hours of observations (thirty 6-minute averages) to demonstrate initial compliance does not apply. Alternatively, ASTM D7520-16, (incorporated by reference, see § 63.14) may be used with the following conditions:
(i) During the digital camera opacity technique (DCOT) certification procedure outlined in section 9.2 of ASTM D7520-16 (incorporated by reference, see § 63.14), the owner or operator or the DCOT vendor must present the plumes in front of various backgrounds of color and contrast representing conditions anticipated during field use such as blue sky, trees, and mixed backgrounds (clouds and/or a sparse tree stand).
(ii) The owner or operator must also have standard operating procedures in place including daily or other frequency quality checks to ensure the equipment is within manufacturing specifications as outlined in section 8.1 of ASTM D7520-16 (incorporated by reference, see § 63.14).
(iii) The owner or operator must follow the recordkeeping procedures outlined in § 63.10(b)(1) for the DCOT certification, compliance report, data sheets, and all raw unaltered JPEGs used for opacity and certification determination.
(iv) The owner or operator or the DCOT vendor must have a minimum of four independent technology users apply the software to determine the visible opacity of the 300 certification plumes. For each set of 25 plumes, the user may not exceed 15 percent opacity of anyone reading and the average error must not exceed 7.5 percent opacity.
(v) Use of this approved alternative does not provide or imply a certification or validation of any vendor's hardware or software. The onus to maintain and verify the certification and/or training of the DCOT camera, software, and operator in accordance with ASTM D7520-16 (incorporated by reference, see § 63.14) and these requirements is on the facility, DCOT operator, and DCOT vendor.
(c) For each nonrecovery coke oven battery subject to the work practice standards in § 63.7293(a), you must demonstrate continuous compliance by maintaining records that document each visual inspection of an oven prior to pushing and that the oven was not pushed unless there was no smoke in the open space above the coke bed and there was an unobstructed view of the door on the opposite side of the oven.
You must report each instance in which you did not meet each emission limitation in this subpart that applies to you. This includes periods of startup, shutdown, and malfunction. You must also report each instance in which you did not meet each work practice standard or operation and maintenance requirement in this subpart that applies to you. These instances are deviations from the emission limitations (including operating limits), work practice
(a) In the event that an affected unit fails to meet an applicable standard, record the number of failures. For each failure, record the start date, start time and duration (in hours) of each failure.
(b) For each failure to meet an applicable standard, record and retain a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit and a description of the method used to estimate the emissions.
(c) Record actions taken to minimize emissions in accordance with § 63.7310(a), and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(e) * * *
(2) For each initial compliance demonstration that does include a performance test, you must submit the notification of compliance status, including a summary of the performance test results, before the close of business on the 60th calendar day following completion of the performance test according to § 63.10(d)(2).
(a)
(1) The first quarterly compliance report for battery stacks must cover the period beginning on the compliance date that is specified for your affected source in § 63.7283 and ending on the last date of the third calendar month. Each subsequent compliance report must cover the next calendar quarter.
(2) The first semiannual compliance report must cover the period beginning on the compliance date that is specified for your affected source in § 63.7283 and ending on June 30 or December 31, whichever date comes first after the compliance date that is specified for your affected source. Each subsequent compliance report must cover the semiannual reporting period from January 1 through June 30 or the semiannual reporting period from July 1 through December 31.
(3) All quarterly compliance reports for battery stacks must be postmarked or delivered no later than one calendar month following the end of the quarterly reporting period. All semiannual compliance reports must be postmarked or delivered no later than July 31 or January 31, whichever date is the first date following the end of the semiannual reporting period.
(4) For each affected source that is subject to permitting regulations pursuant to 40 CFR part 70 or 40 CFR part 71, and if the permitting authority has established dates for submitting semiannual reports pursuant to 40 CFR 70.6(a)(3)(iii)(A) or 40 CFR 71.6(a)(3)(iii)(A), you may submit the first and subsequent compliance reports according to the dates the permitting authority has established instead of according to the dates in paragraphs (a)(1) through (4) of this section.
(b)
(c)
(1) Company name and address (including county).
(2) Statement by a responsible official, with the official's name, title, and signature, certifying the truth, accuracy, and completeness of the content of the report. If your report is submitted via the Compliance and Emissions Data Reporting Interface (CEDRI), the certifier's electronic signature during the submission process replaces this requirement.
(3) Date of report and beginning and ending dates of the reporting period. You are no longer required to provide the date of report when the report is submitted via CEDRI.
(4) Beginning on January 2, 2025, if you failed to meet an applicable standard, the compliance report must include, for each instance, the start date, start time, and duration (in hours) of each failure. For each failure, the compliance report must include a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
(5) If there were no deviations from the continuous compliance requirements in § 63.7333(e) for battery stacks, a statement that there were no deviations from the emission limitations during the reporting period. If there were no deviations from the continuous compliance requirements in §§ 63.7333 through 63.7335 that apply to you (for all affected sources other than battery stacks), a statement that there were no deviations from the emission limitations, work practice standards, or operation and maintenance requirements during the reporting period.
(6) If there were no periods during which a continuous monitoring system (including COMS, continuous emission monitoring system (CEMS), or CPMS) was out-of-control as specified in § 63.8(c)(7), a statement that there were no periods during which a continuous monitoring system was out-of-control during the reporting period.
(7) For each deviation from an emission limitation in this subpart (including quench water limits) and for each deviation from the requirements for work practice standards in this subpart that occurs at an affected source where you are not using a continuous monitoring system (including a COMS, CEMS, or CPMS) to comply with the emission limitations in this subpart, the compliance report must contain the information in paragraphs (7)(i) and (ii) of this section. This includes periods of startup, shutdown, and malfunction.
(i) The total operating time of each affected source during the reporting period.
(ii) Information on the duration and cause of deviations (including unknown cause, if applicable) as applicable and the corrective action taken.
(8) For each deviation from an emission limitation occurring at an affected source where you are using a continuous monitoring system (including COMS, CEMS, or CPMS) to comply with the emission limitation in this subpart, you must include the information in paragraphs (c)(4) and (8)(i) through (xii) of this section. This includes periods of startup, shutdown, and malfunction.
(i) The date and time that each malfunction started and stopped.
(ii) The start date, start time, and duration in hours that each continuous monitoring system (including COMS, CEMS, or CPMS) was inoperative, except for zero (low-level) and high-level checks.
(iii) The start date, start time, and duration in hours that each continuous monitoring system (including COMS, CEMS, or CPMS) was out-of-control, including the information in § 63.8(c)(8).
(iv) The date and time that each deviation started and stopped, the duration in hours, and whether each deviation occurred during a period of startup, shutdown, or malfunction or during another period.
(v) A summary of the total duration in hours of the deviation during the reporting period and the total duration as a percent of the total source operating time during that reporting period.
(vi) A breakdown of the total duration in hours of the deviations during the reporting period into those that are due to startup, shutdown, control equipment problems, process problems, other known causes, and other unknown causes.
(vii) A summary of the total duration in hours of continuous monitoring system downtime during the reporting period and the total duration of continuous monitoring system downtime as a percent of the total source operating time during the reporting period.
(viii) An identification of each HAP that was monitored at the affected source.
(ix) A brief description of the process units.
(x) A brief description of the continuous monitoring system.
(xi) The date of the latest continuous monitoring system certification or audit.
(xii) A description of any changes in continuous monitoring systems, processes, or controls since the last reporting period.
(xiii) The total operating time of each affected source during the reporting period.
(d) [Reserved]
(e)
(f)
(g)
(h)
(1) The EPA will make all the information submitted through CEDRI available to the public without further notice to you. Do not use CEDRI to submit information you claim as CBI. Although we do not expect persons to assert a claim of CBI, if you wish to assert a CBI claim for some of the information submitted under paragraph (f) or (g) of this section, you must submit a complete file, including information claimed to be CBI, to the EPA.
(2) For performance test reports according to paragraph (g) of this section, the file must be generated using the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website.
(3) Clearly mark the part or all of the information that you claim to be CBI. Information not marked as CBI may be authorized for public release without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
(4) The preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol, or other online file sharing services. Electronic submissions must be transmitted directly to the OAQPS CBI Office at the email address
(5) If you cannot transmit the file electronically, you may send CBI information through the postal service to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Group Leader, Measurement Policy Group or Coke Oven Sector Lead as indicated in paragraph (4) of this section. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.
(6) All CBI claims must be asserted at the time of submission. Anything submitted using CEDRI cannot later be claimed CBI. Furthermore, under CAA section 114(c), emissions data is not entitled to confidential treatment, and the EPA is required to make emissions data available to the public. Thus, emissions data will not be protected as CBI and will be made publicly available.
(7) You must submit the same file submitted to the CBI office with the CBI omitted to the EPA via the EPA's CDX as described in paragraph (f) or (g) of this section.
(a) You must keep the records specified in paragraphs (a)(1) through (5) of this section.
(1) A copy of each notification and report that you submitted to comply with this subpart, including all documentation supporting any initial notification or notification of compliance status that you submitted, according to the requirements in § 63.10(b)(2)(xiv).
(2) Beginning on January 2, 2025, records of the occurrence and duration of each startup, shutdown, or malfunction of process, air pollution control, and monitoring equipment.
(3) Beginning on January 2, 2025, for each failure to meet an applicable standard, a list of the affected sources or equipment, whether the failure occurred during startup, shutdown, or malfunction, and records of the start date, start time, and duration (in hours) of each failure to meet an applicable standard. Include an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
(4) Beginning on January 2, 2025, records of the actions taken to minimize emissions in accordance with § 63.7310(a), and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(5) Records of performance tests, performance evaluations, and opacity observations as required in § 63.10(b)(2)(viii).
(b) For each COMS or CEMS, you must keep the records specified in paragraphs (b)(1) through (4) of this section.
(1) Records described in § 63.10(b)(2)(vi) through (xi).
(2) Monitoring data for COMS during a performance evaluation as required in § 63.6(h)(7)(i) and (ii).
(3) You shall keep these written procedures on record for the life of the affected source or until the affected source is no longer subject to the provisions of this part, to be made available for inspection, upon request, by the Administrator. If the performance evaluation plan is revised, you shall keep previous (
(4) Records of the date and time that each deviation started and stopped, the cause of the deviation, and whether the deviation occurred during a period of startup, shutdown, or malfunction or during another period.
(c) You must keep the records in § 63.6(h)(6) for visual observations.
(d) You must keep the records required in §§ 63.7333 through 63.7335 to show continuous compliance with each emission limitation, work practice standard, and operation and maintenance requirement that applies to you.
The revision and addition read as follows:
(c) * * *
(1) Approval of alternatives to work practice standards for fugitive pushing emissions in § 63.7291(a) for a by-product coke oven battery with vertical flues, fugitive pushing emissions in § 63.7292(a) for a by-product coke oven battery with horizontal flues, fugitive pushing emissions in § 63.7293 for a nonrecovery coke oven battery, soaking for a by-product coke oven battery in § 63.7294(a), and quenching for a coke oven battery in § 63.7295(b) under § 63.6(g).
(7) Approval of an alternative to any electronic reporting to the EPA required by this subpart.
The additions and revisions read as follows:
As required in § 63.7350, you must comply with each applicable requirement of the NESHAP General Provisions (subpart A of this part) as shown in the following table:
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Proposed rule.
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2025. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this proposed rule would update requirements for the Conditions for Coverage for ESRD Facilities, ESRD Quality Incentive Program, and ESRD Treatment Choices Model.
To be assured consideration, comments must be received at one of the addresses provided below, by August 26, 2024.
In commenting, please refer to file code CMS-1805-P.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents.
This rule proposes changes related to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS),
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), established that beginning CY 2012, and each subsequent year, the Secretary of the Department of Health and Human Services (the Secretary) shall annually increase payment amounts by an ESRD market basket percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule proposes updates to the ESRD PPS for CY 2025.
On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the TPEA amended section 1834 of the Act by adding a new subsection (r) that provides for payment for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate beginning January 1, 2017. This proposed rule would update the AKI payment rate for CY 2025. Additionally, this rule proposes to extend payment for home dialysis and the payment adjustment for home and self-dialysis training to renal dialysis services provided to beneficiaries with AKI.
The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is authorized by section 1881(h) of the Act. The Program establishes incentives for facilities to achieve high quality performance on measures with the goal of improving outcomes for ESRD beneficiaries. This rule proposes to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy measure topic and to remove National Healthcare Safety Network (NHSN) Dialysis Event reporting measure beginning with Payment Year (PY) 2027. This rule also requests public comment on two topics relevant to the ESRD QIP.
The ETC Model is a mandatory Medicare payment model tested under section 1115A of the Act. The ETC Model is operated by the Center for Medicare and Medicaid Innovation (Innovation Center). The ETC Model tests the use of payment adjustments to encourage greater utilization of home dialysis and kidney transplants, to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures. The ETC Model was finalized as part of a final rule published in the
This proposed rule would make certain changes to the methodology CMS uses to identify transplant failure for the purposes of defining an ESRD beneficiary and attributing an ESRD beneficiary to the ETC Model. We are also soliciting input from the public
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Beginning with PY 2027, we are proposing to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure, on which facility performance is scored on a single measure based on one set of performance standards, with a Kt/V Dialysis Adequacy measure topic, which would be comprised of four individual Kt/V measures and scored based on a separate set of performance standards for each of those measures. We are also proposing to remove the National Healthcare Safety Network (NHSN) Dialysis Event reporting measure from the ESRD QIP measure set beginning with PY 2027. We are requesting public comment on a potential health equity payment adjustment and are also requesting public comment on potential future updates to the data validation policy.
We are proposing a modification to the methodology used to attribute ESRD Beneficiaries to the ETC Model, specifically, to the definition of an ESRD Beneficiary at 42 CFR 512.310. Under the ETC Model, CMS attributes ESRD beneficiaries to the ETC Model that meet several criteria including having a kidney transplant failure less than 12 months after the transplant date. We are proposing to refine the methodology we use identify ESRD Beneficiaries with a kidney transplant failure to reduce the likelihood that CMS is overestimating the true number of transplant failures for the purposes of the model. We provide more detail on the proposal and its rationale in section V.B of this proposed rule.
We are also seeking input from the public through a RFI on the future of the ETC Model, potential successor Models and other approaches CMS may consider to support beneficiary access to patient-centered modalities for treatment of ESRD.
In section VIII.D.5 of this proposed rule, we set forth a detailed analysis of the impacts that the proposed changes would have on affected entities and beneficiaries. The impacts include the following:
The impact table in section VIII.D.5.a of this proposed rule displays the estimated change in Medicare payments to ESRD facilities in CY 2025 compared to estimated Medicare payments in CY 2024. The overall impact of the CY 2025 payment changes is projected to be a 2.2 percent increase in Medicare payments. Hospital-based ESRD facilities have an estimated 3.9 percent increase in Medicare payments compared with freestanding ESRD facilities with an estimated 2.1 percent increase. We estimate that the aggregate ESRD PPS expenditures would increase by approximately $170 million in CY 2025 compared to CY 2024 as a result of the proposed payment policies in this rule. Because of the projected 2.2 percent overall payment increase, we estimate there would be an increase in beneficiary coinsurance payments of 2.2 percent in CY 2025, which translates to approximately $30 million.
Section 1881(b)(14)(D)(iv) of the Act provides that the ESRD PPS may include such other payment adjustments as the Secretary determines appropriate. Under this authority, CMS implemented § 413.234 to establish the TDAPA, a transitional drug add-on payment adjustment for certain new renal dialysis drugs and biological products and § 413.236 to establish the TPNIES, a transitional add-on payment adjustment for certain new and innovative equipment and supplies. The TDAPA and the TPNIES are not budget neutral.
As discussed in section II.D of this proposed rule, since no new items were approved for the TPNIES for CY 2024 (88 FR 76431) there are no continuing TPNIES payments for CY 2025. In addition, since we did not receive any applications for the TPNIES for CY 2025, there would be no new TPNIES payments for CY 2025. As discussed in section II.E of this proposed rule, the TDAPA payment periods for Jesduvroq and DefenCath®, would continue into CY 2025. As described in section VIII.D.5.b of this proposed rule, we estimate that the TDAPA payment amounts in CY 2025 would be approximately $207,675, of which, $41,535 would be attributed to beneficiary coinsurance amounts.
The impact table in section VIII.D.5.c of this proposed rule displays the estimated change in Medicare payments to ESRD facilities for renal dialysis services furnished to individuals with AKI compared to estimated Medicare payments for such services in CY 2024. The overall impact of the CY 2025 changes is projected to be a 1.9 percent increase in Medicare payments for individuals with AKI. Hospital-based ESRD facilities would have an estimated 2.6 percent increase in Medicare payments compared with freestanding ESRD facilities that would have an estimated 1.9 percent increase. The overall impact reflects the effects of the proposed Medicare payment rate update and the proposed CY 2025 ESRD PPS wage index, as well as the proposed policy to extend payment for AKI dialysis at home, which is not expected to have any impact on payment rates. As discussed in section III.C.3, we are proposing to extend the ESRD PPS home and self-dialysis training add-on adjustment to AKI patients; however, that adjustment is required to be implemented in a budget neutral manner for AKI payments, so it would not have any impact on the overall payment amounts for AKI renal dialysis services and therefore is not included in these estimates. We estimate that the aggregate Medicare payments made to ESRD facilities for renal dialysis services furnished to individuals with AKI, at the proposed CY 2025 ESRD PPS base rate, would increase by $1 million in CY 2025 compared to CY 2024.
We estimate that, as a result of previously finalized policies and changes to the ESRD QIP that we are proposing in this proposed rule, the overall economic impact of the PY 2027 ESRD QIP will be approximately $145.1 million. The $145.1 million estimate for PY 2027 includes $130.5 million in costs associated with the collection of information requirements and approximately $14.6 million in payment reductions across all facilities.
The proposed change to the definition of an ESRD Beneficiary for the purposes of attribution in the ETC Model is not expected to have a net effect on the model's projected economic impact.
On January 1, 2011, CMS implemented the ESRD PPS, a case-mix adjusted bundled PPS for renal dialysis services furnished by ESRD facilities, as required by section 1881(b)(14) of the Act, as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148), established that beginning with CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket percentage increase reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) included several provisions that apply to the ESRD PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act, which required the Secretary, by comparing per patient utilization data from 2007 with such data from 2012, to reduce the single payment for renal dialysis services furnished on or after January 1, 2014, to reflect the Secretary's estimate of the change in the utilization of ESRD-related drugs and biologicals
Section 632(b) of ATRA prohibited the Secretary from paying for oral-only ESRD-related drugs and biologicals under the ESRD PPS prior to January 1, 2016. Section 632(c) of ATRA required the Secretary, by no later than January 1, 2016, to analyze the case-mix payment adjustments under section 1881(b)(14)(D)(i) of the Act and make appropriate revisions to those adjustments.
On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted. Section 217 of PAMA included several provisions that apply to the ESRD PPS. Specifically, sections 217(b)(1) and (2) of PAMA amended sections 1881(b)(14)(F) and (I) of the Act and replaced the drug utilization adjustment that was finalized in the CY 2014 ESRD PPS final rule (78 FR 72161 through 72170) with specific provisions that dictated the market basket update for CY 2015 (0.0 percent) and how the market basket percentage increase should be reduced in CY 2016 through CY 2018.
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to provide that the Secretary may not pay for oral-only ESRD-related drugs under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) of PAMA further amended section 632(b)(1) of ATRA by requiring that in establishing payment for oral-only drugs under the ESRD PPS, the Secretary must use data from the most recent year available. Section 217(c) of PAMA provided that as part of the CY 2016 ESRD PPS rulemaking, the Secretary shall establish a process for (1) determining when a product is no longer an oral-only drug; and (2) including new injectable and intravenous products into the ESRD PPS bundled payment.
Section 204 of the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) amended section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, to provide that payment for oral-only renal dialysis drugs and biological products cannot be made under the ESRD PPS bundled payment prior to January 1, 2025.
Under the ESRD PPS, a single per-treatment payment is made to an ESRD facility for all the renal dialysis services defined in section 1881(b)(14)(B) of the Act and furnished to an individual for the treatment of ESRD in the ESRD facility or in a patient's home. We have codified our definition of renal dialysis services at § 413.171, which is in 42 CFR part 413, subpart H, along with other ESRD PPS payment policies. The ESRD PPS base rate is adjusted for characteristics of both adult and pediatric patients and accounts for patient case-mix variability. The adult case-mix adjusters include five categories of age, body surface area, low body mass index, onset of dialysis, and four comorbidity categories (that is, pericarditis, gastrointestinal tract bleeding, hereditary hemolytic or sickle cell anemia, myelodysplastic syndrome). A different set of case-mix adjusters are applied for the pediatric population. Pediatric patient-level adjusters include two age categories (under age 13, or age 13 to 17) and two dialysis modalities (that is, peritoneal or hemodialysis) (§ 413.235(a) and (b)(1)).
The ESRD PPS provides for three facility-level adjustments. The first payment adjustment accounts for ESRD facilities furnishing a low volume of dialysis treatments (§ 413.232). The second payment adjustment reflects differences in area wage levels developed from core-based statistical areas (CBSAs) (§ 413.231). The third payment adjustment accounts for ESRD facilities furnishing renal dialysis services in a rural area (§ 413.233).
There are six additional payment adjustments under the ESRD PPS. The ESRD PPS provides adjustments, when applicable, for: (1) a training add-on for home and self-dialysis modalities (§ 413.235(c)); (2) an additional payment for high cost outliers due to unusual variations in the type or amount of medically necessary care (§ 413.237); (3) a TDAPA for certain new renal dialysis drugs and biological products (§ 413.234(c)); (4) a TPNIES for certain new and innovative renal dialysis equipment and supplies (§ 413.236(d)); (5) a transitional pediatric ESRD add-on payment adjustment (TPEAPA) of 30 percent of the per-treatment payment amount for renal dialysis services furnished to pediatric ESRD patients (§ 413.235(b)(2)); and (6) a post-TDAPA add-on payment adjustment for certain new renal dialysis drugs and biological products after the end of the TDAPA period (§ 413.234(g)).
Policy changes to the ESRD PPS are proposed and finalized annually in the
Most recently, we published a final rule, which appeared in the November 6, 2023, issue of the
In accordance with section 1881(b)(14)(F)(i) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts are required to be annually increased by an ESRD market basket percentage increase and reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity adjustment may result in the increase factor being less than 0.0 for a year and may result in payment rates for a year being less than the payment rates for the preceding year. Section 1881(b)(14)(F)(i) of the Act also provides that the market basket increase factor should reflect the changes over time in the prices of an appropriate mix of goods and services included in renal dialysis services.
As required under section 1881(b)(14)(F)(i) of the Act, CMS developed an all-inclusive ESRDB input price index using CY 2008 as the base year (75 FR 49151 through 49162). We subsequently revised and rebased the ESRDB input price index to a base year of CY 2012 in the CY 2015 ESRD PPS final rule (79 FR 66129 through 66136). In the CY 2019 ESRD PPS final rule (83 FR 56951 through 56964), we finalized a rebased ESRDB input price index to reflect a CY 2016 base year. In the CY 2023 ESRD PPS final rule (87 FR 67141 through 67154), we finalized a revised and rebased ESRDB input price index to reflect a CY 2020 base year.
Although “market basket” technically describes the mix of goods and services used for ESRD treatment, this term is also commonly used to denote the input price index (that is, cost categories, their respective weights, and price proxies combined) derived from a market basket. Accordingly, the term “ESRDB market basket,” as used in this document, refers to the ESRDB input price index.
The ESRDB market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres-type price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. Any changes in the quantity or mix of goods and services (that is, intensity) purchased over time are not measured.
We propose to use the 2020-based ESRDB market basket as finalized in the CY 2023 ESRD PPS final rule (87 FR 67141 through 67154) to compute the proposed CY 2025 ESRDB market basket percentage increase based on the best available data. Consistent with historical practice, we propose to estimate the ESRDB market basket percentage increase based on IHS Global Inc.'s (IGI) forecast using the most recently available data at the time of rulemaking. IGI is a nationally recognized economic and financial forecasting firm with which CMS contracts to forecast the components of the market baskets. As discussed in section II.B.1.b.(3) of this proposed rule, we are proposing to calculate the market basket update for CY 2025 based on the proposed market basket percentage increase and the proposed productivity adjustment, following our longstanding methodology.
Based on IGI's first quarter 2024 forecast of the 2020-based ESRDB market basket, the proposed CY 2025 market basket percentage increase is 2.3 percent. We are also proposing that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket percentage increase), we would use such data, if appropriate, to determine the CY 2025 market basket percentage increase in the final rule.
Under section 1881(b)(14)(F)(i) of the Act, as amended by section 3401(h) of the Affordable Care Act, for CY 2012 and each subsequent year, the ESRDB market basket percentage increase shall be reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable fiscal year (FY), year, cost reporting period, or other annual period) (the “productivity adjustment”).
The Bureau of Labor Statistics (BLS) publishes the official measures of productivity for the United States economy. As we noted in the CY 2023 ESRD PPS final rule (87 FR 67155), the productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act previously was published by BLS as private nonfarm business MFP. Beginning with the November 18, 2021, release of productivity data, BLS replaced the term “multifactor productivity” with “total factor productivity” (TFP). BLS noted that this is a change in terminology only and would not affect the data or methodology.
Based on IGI's first quarter 2024 forecast, the proposed productivity adjustment for CY 2025 (the 10-year moving average of TFP for the period ending CY 2025) is 0.5 percentage point. Furthermore, we are proposing that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the productivity adjustment), we would use such data, if appropriate, to determine the CY 2025 productivity adjustment in the final rule.
In accordance with section 1881(b)(14)(F)(i) of the Act, we propose to base the CY 2025 market basket percentage increase on IGI's first quarter 2024 forecast of the 2020-based ESRDB market basket. We propose to then reduce the market basket percentage increase by the estimated productivity adjustment for CY 2025 based on IGI's first quarter 2024 forecast. Therefore, the proposed productivity-adjusted CY 2025 ESRDB market basket update is equal to 1.8 percent (2.3 percent market basket percentage increase reduced by a 0.5 percentage point productivity adjustment). Furthermore, as noted previously, we are proposing that if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket percentage increase and/or productivity adjustment), we would use such data, if appropriate, to determine the CY 2025 market basket percentage increase and productivity adjustment in the final rule.
We define the labor-related share as those expenses that are labor-intensive and vary with, or are influenced by, the local labor market. The labor-related share of a market basket is determined by identifying the national average proportion of operating costs that are related to, influenced by, or vary with the local labor market. For the CY 2025 ESRD PPS payment update, we are proposing to continue using a labor-related share of 55.2 percent, which was finalized in the CY 2023 ESRD PPS final rule (87 FR 67153 through 67154).
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD PPS may include a geographic wage index payment adjustment, such as the index referred to in section 1881(b)(12)(D) of the Act, as the Secretary determines to be appropriate. In the CY 2011 ESRD PPS final rule (75 FR 49200), we finalized an adjustment for wages at § 413.231. Specifically, we established a policy to adjust the labor-related portion of the ESRD PPS base rate to account for geographic differences in the area wage levels using an appropriate wage index, which reflects the relative level of hospital wages and wage-related costs in the geographic area in which the ESRD facility is located. Under current policy, we use the Office of Management and Budget's (OMB's) CBSA-based geographic area designations to define urban and rural areas and their corresponding wage index values (75 FR 49117). OMB publishes bulletins regarding CBSA changes, including changes to CBSA numbers and titles. The bulletins are available online at
We have also adopted methodologies for calculating wage index values for ESRD facilities that are located in urban and rural areas where there are no hospital data. For a full discussion, see the CY 2011 and CY 2012 ESRD PPS final rules at 75 FR 49116 through 49117 and 76 FR 70239 through 70241, respectively. For urban areas with no hospital data, we have computed the average wage index value of all hospitals in urban areas within the State to serve as a reasonable proxy for the wage index of that urban CBSA. For rural areas with no hospital data, we have computed the wage index using the average hospital wage index values from all contiguous CBSAs to represent a reasonable proxy for that rural area. We applied the statewide urban average based on the average of all urban areas within the State to Hinesville Fort Stewart, Georgia (78 FR 72173), and we applied the wage index for Guam to American Samoa and the Northern Mariana Islands (78 FR 72172).
Under § 413.231(d), a wage index floor value of 0.6000 is applied under the ESRD PPS as a substitute wage index for areas with very low wage index values, as finalized in the CY 2023 ESRD PPS final rule (87 FR 67161). Currently, all areas with wage index values that fall below the floor are located in Puerto Rico and the US Virgin Islands. However, the wage index floor value is applicable for any area that may fall below the floor. A further description of the history of the wage index floor under the ESRD PPS can be found in the CY 2019 ESRD PPS final rule (83 FR 56964 through 56967) and the CY 2023 ESRD PPS final rule (87 FR 67161).
An ESRD facility's wage index is applied to the labor-related share of the ESRD PPS base rate. In the CY 2023 ESRD PPS final rule (87 FR 67153), we finalized the use of a labor-related share of 55.2 percent. In the CY 2021 ESRD PPS final rule (85 FR 71436), we updated the OMB delineations as described in the September 14, 2018, OMB Bulletin No. 18-04, beginning with the CY 2021 ESRD PPS wage index. In that same rule, we finalized the application of a 5 percent cap on any decrease in an ESRD facility's wage index from the ESRD facility's wage index from the prior CY. We finalized that the transition would be phased in over 2 years, such that the reduction in an ESRD facility's wage index would be capped at 5 percent in CY 2021, and no cap would be applied to the reduction in the wage index for the second year, CY 2022. In the CY 2023 ESRD PPS final rule (87 FR 67161), we finalized a permanent policy under § 413.231(c) to apply a 5 percent cap on any decrease in an ESRD facility's wage index from the ESRD facility's wage index from the prior CY. For CY 2025, as discussed in section II.B.1.b.(4) of this proposed rule, the proposed labor-related share to which the wage index would be applied is 55.2 percent.
In the CY 2011 ESRD PPS final rule (75 FR 49116) and the CY 2011 final rule on Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B (75 FR 73486) we established an ESRD PPS wage index methodology to use the most recent pre-floor, pre-reclassified hospital wage data collected annually under the hospital inpatient prospective payment system (IPPS). The ESRD PPS wage index values have historically been calculated without regard to geographic reclassifications authorized for acute care hospitals under sections 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that are unadjusted for occupational mix.
CMS has received feedback on our longstanding ESRD PPS wage index methodology from interested parties through comments on routine wage index updates in the annual ESRD PPS proposed rules. Commenters often suggest specific improvements for the
In past years some interested parties have contended that the methodology used to construct the current ESRD PPS wage index does not accurately reflect the ESRD facility labor market. These interested parties have noted that the ESRD PPS wage index is based on the IPPS wage index, which uses hospital data, which commenters have stated may not be applicable for ESRD facilities. More specifically, commenters have suggested that the types of labor used in ESRD facilities differ significantly from the types of labor used by hospitals, which may result in the use of relative wage values across the United States that do not accurately match the actual relative wages paid by ESRD facilities. For example, if ESRD facilities have a different proportion of registered nurses (RNs), technicians and administrative staff compared to hospitals, and if wages for each of those labor categories vary differentially across the country, it is possible that relative wages for ESRD facilities, given their occupational mix, would vary differently from relative wages for hospitals across CBSAs. Because of this, some commenters have specifically requested that CMS develop an ESRD PPS wage index based only on data from ESRD facilities. Additionally, some commenters have criticized the time lag associated with using the IPPS wage index, which is generally based on data from four FYs prior to the rulemaking year (see, for example, 88 FR 58961).
In response to feedback from interested parties on the ESRD PPS wage index, CMS's data contractor hosted a Technical Expert Panel (TEP) in December of 2019.
Panelists at this TEP generally indicated their preference for the presented alternative wage index methodology, because it utilized more recent wage data from the BLS OEWS program. Panelists also favored how the alternative methodology was more targeted to ESRD facilities by utilizing FTE data from ESRD facility cost reports in determining the occupational mix. Some panelists voiced concerns about using publicly available BLS geographic area data, as the data do not disaggregate wages by health care sector, and therefore wages from acute care hospitals are not differentiated from outpatient care centers and other non-hospital health care settings. Some panelists noted that this would result in a wage index based on the publicly available BLS OEWS data having some of the same limitations for which the use of the IPPS wage index has been criticized—mainly that it includes wage data from hospitals.
Based on feedback we received in response to past ESRD PPS proposed rules and from the December 2019 TEP, we have developed a new ESRD PPS wage index methodology that we believe better reflects the ESRD facility labor market. Similar to the methodology presented in the December 2019 TEP, this proposed new methodology utilizes two data sources: one for occupational mix and one for geographic wages. First, we determine a national ESRD facility occupational mix (NEFOM) based on cost report data from freestanding ESRD facilities. Second, we extract and use data from the publicly available BLS OEWS survey on the average wages in each CBSA for each labor category present in the NEFOM. We note that because the publicly available BLS data are available at the Metropolitan Statistical Area (MSA), non-MSA and New England City and Town Area (NECTA) levels, and the wage index is designated at the CBSA level (which uses MSAs and other area designations that differ from non-MSAs and NECTAs), we use the area definition dataset
The BLS OEWS program publishes annual estimates of employment and wages by occupation. Each set of OEWS estimates is based on data from six semiannual survey panels collected over a 3-year period. For example, the May 2022 OEWS wage estimates, published in April 2023, are based on six semiannual survey panels from November 2019 to May 2022. We are proposing to use publicly available mean hourly wage data at the MSA level,
The BLS OEWS data used for this analysis includes mean wages by occupation for all industries combined located in a MSA (or non-MSA area or NECTA), including the hospital industry. While interested parties have criticized the current ESRD PPS wage index methodology's sole reliance on hospital data, we believe that inpatient hospital data is appropriate to include here for several reasons. Principally, as explained later in this section, the wage data is being weighted based on an occupational mix that is specific to ESRD facilities, which makes this proposed methodology more accurate to the wage environment of ESRD facilities regardless of the source of the wage data. Additionally, ESRD facility data is included in the BLS data, while ESRD facilities generally are not included in the hospital cost report data used in the IPPS wage index (with the exception of hospital-based ESRD facilities). Lastly, hospitals are a major contributor to labor markets, and it is reasonable to think that ESRD facilities compete with hospitals (as well as other healthcare facilities) when it comes to hiring labor; as such, the inclusion of hospital data would provide additional insight into the labor markets of these areas.
A limitation of the publicly available BLS OEWS data is that the survey only includes information on the wages that employers paid to their employees. Therefore, the OEWS does not include self-employed contract labor wages or benefits paid to employees, which are reflected in the IPPS wage index. Nevertheless, we believe that this data source would be an improvement over the use of the IPPS wage index for the ESRD PPS, as its purpose is to identify geographic differences in wages. Assuming wages spent on self-employed contract labor wages and employee benefits vary similarly to employee wages; we would not expect any significant difference arising from this limitation of the BLS data. We anticipate that most traveling nurses and technicians would be employed by an agency, and therefore would be included in the OEWS estimates; however as worksite location reporting is optional,
One potential concern about use of the BLS OEWS data is that in some cases, the BLS OEWS may not have usable data for a county for an occupation, which is used in the construction of the new ESRD PPS wage index according to the methodology presented later in this section. This occurs when BLS is unable to publish a wage estimate for a specific occupation and area because the estimate does not meet BLS quality or confidentiality standards.
We have conducted an analysis on historical BLS OEWS data for the occupations presented in table 1. We have found that mean hourly wages for these categories are increasing over time, consistent with what we would expect given the ESRD PPS market basket increases. Given this analysis, we believe that the BLS OEWS data are reasonably stable and appropriately reflect general wage inflation trends that ESRD facilities face. Therefore, the mean hourly wage estimates for a given year are appropriately reflective of wages which ESRD facilities face.
Under § 413.198(b)(1), all ESRD facilities must submit the appropriate CMS-approved cost report in accordance with §§ 413.20 and 413.24, which provide rules on financial data and reports, and adequate cost data and cost finding, respectively. Generally, these cost reports have a time range of January 1 to December 31 of a given year, but they can represent any 12-month period. Included in these cost reports is information on the number of full-time equivalent (FTE) positions employed by the ESRD facility. FTEs are stratified by occupation type, such as RNs, LPNs, technicians, and administrative staff. For the purpose of these cost reports, an FTE represents a 40-hour work week averaged across the year. Specifically, the cost reports define FTEs as the sum of all hours for which employees were paid during the year divided by 2080 hours. The cost reports also state personnel involved in more than one activity must have their time prorated among those activities. For example, an RN who provided professional services and administrative services is counted in both the RN line and the administrative line according to the number of hours spent in each activity.
For the proposed methodology presented in this section, we are proposing to use FTEs to calculate the occupational mix for all freestanding ESRD facilities. For the purposes of this section, we use the term “freestanding ESRD facilities” to mean ESRD facilities that complete the independent renal dialysis facility cost report (Form CMS 265-11, OMB No. 0938-0050). We note that these ESRD facilities are a subset of “independent” facilities as defined at § 413.174(b), as cost-reporting is only one of 5 criteria used in the determination of whether an ESRD facility is independent or hospital-based as listed at § 413.174(c). For the purposes of this section, we refer to ESRD facilities that complete the hospital cost report (Form CMS 2552-10, OMB No. 0938-0050) as “ESRD facilities that are financially integrated
We note that the NEFOM is calculated as a part of the proposed wage index methodology described in detail below from freestanding ESRD facilities cost reports, and that the NEFOM is not an input in the wage index calculation. However, we are presenting the NEFOM here to inform the calculation process for any interested parties which wish to replicate the calculation.
For this proposed methodology, we are proposing to only utilize data from freestanding ESRD facilities, which comprise the vast majority of ESRD facilities. ESRD facilities that are financially integrated with a hospital represent approximately 4.5 percent of ESRD facilities. It is necessary to make this distinction, as ESRD facilities that are financially integrated with a hospital complete a different cost report form (Form CMS 2552-10, OMB No. 0938-0050), which does not include all the occupational categories included on the freestanding facility cost report (Form CMS 265-11, OMB No. 0938-0050). Specifically, ESRD facilities that are financially integrated with a hospital do not include administrative and management staff hours in their cost reports. FTE data for administrative and management staff are necessary for this analysis, so we are proposing to exclude hospital-integrated cost reports. We believe that the occupational mix for freestanding ESRD facilities is likely similar to the mix for ESRD facilities that are financially integrated with a hospital (which, as noted earlier, make up a small proportion of all ESRD facilities), such that we would not expect significantly different results if we were able to include ESRD facilities that are financially integrated with a hospital in this analysis.
We conducted additional analyses to ensure that this occupational mix data would be appropriate for the construction of an ESRD facility wage index. First, we reviewed the occupational mix for ESRD facilities on a regional level to determine if the use of a single national occupational mix was appropriate. While we found some variation across regions, the variation was generally relatively small between regions, with the weight values for each occupation being within a few percentage points. The main exceptions to this were in the United States territories, which had higher variation in occupational mix, likely due in large part to the relatively few ESRD facilities in those regions. Additionally, we found that lower volume ESRD facilities tended to have slightly different occupational mixes, requiring relatively more administrative and management staff FTEs, likely due to the lack of economies of scale for these occupations at lower treatment volume levels. Second, we conducted an analysis on the change in the national occupational mix over the past 5 years and found little variation over this time period. Both of these analyses indicate that the use of a single national occupational mix is appropriate for constructing an ESRD facility wage index as the occupational mix is reasonably similar to most region's occupational mixes and relatively stable over time.
Additionally, we are proposing to use treatment volume data from freestanding ESRD facilities as reported on freestanding ESRD facility cost reports. This treatment volume data is used in the wage index calculation as a weight on the county level wages when calculating the wages for a CBSA. The calculation is described in further detail in section II.B.2.b.(2)(b) of this proposed rule.
We emphasize the importance of accurate cost report data for this proposed policy as well as other current and potential policies under the ESRD PPS, such as facility-level or case-mix adjustment refinement. We strongly urge ESRD facilities to carefully review cost report data to ensure continued accuracy so that future refinements to the ESRD PPS are based on the best data possible.
The new proposed wage index methodology uses the established ESRD PPS wage index methodology, which is based on the IPPS hospital wage index, for the purposes of standardizing the new wage index (step 6 in the methodology described in section II.B.2.b.(2).(b)). Consistent with our established ESRD PPS methodology, we use the most recent pre-floor, pre-reclassified hospital wage data collected annually under the IPPS. The ESRD PPS wage index values under the established methodology are calculated without regard to geographic reclassifications authorized for acute care hospitals under sections 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that are unadjusted for occupational mix. For CY 2025, the updated wage data are generally for hospital cost reporting periods beginning on or after October 1, 2020, and before October 1, 2021 (FY 2021 cost report data). Under § 413.231(d), a wage index floor value of 0.6000 is applied under the ESRD PPS as a substitute wage index for areas with very low wage index values, as finalized in the CY 2023 ESRD PPS final rule (87 FR 67161). For the purposes of the proposed new wage index methodology, we are referring to this older wage index methodology as the “ESRD PPS legacy wage index.” Consistent with our established policy of updating wage indices in the final rule, we intend to use the most recent IPPS wage index for the construction of the CY 2025 ESRD PPS legacy wage index for the final rule. We note that the purpose of calculating the ESRD PPS legacy wage index is solely for standardizing the new ESRD PPS wage index, ensuring that the treatment weighted average of the new ESRD PPS wage index is the same as it would have been under the established methodology. This ensures that the changes associated with the proposed new wage index methodology are contained to the wage index, whereas changes associated with shifts in utilization would be reflected in the wage index budget neutrality factor. For example, if the new methodology resulted in a significant increase in the number of high-wage index facilities, the standardization factor would decrease wage index values across the board to keep the treatment-weighted average of the legacy and new wage index methodologies the same; in contrast, if utilization trends resulted in a significant increase in the number of treatments furnished by ESRD facilities in high-wage index areas, the treatment weighted average of both the legacy and new wage index methodologies would increase which would need to be accounted-for by the wage index budget neutrality adjustment factor. This is described in more detail in step 6 of the proposed new wage index methodology in section II.B.2.b.(2)(b) of this proposed rule.
One concern expressed by interested parties about the current ESRD PPS wage index methodology is that the IPPS wage index, used as its basis, uses data from approximately 4 fiscal years prior. Interested parties have opined that this delay makes the ESRD PPS wage index less responsive to certain changes in wages, such as inflation.
As previously discussed in this section, the new ESRD PPS wage index methodology that we are proposing would use data from BLS OEWS and freestanding ESRD facility cost reports. BLS publishes OEWS data annually with a May reference date, with estimates typically released in late March or early April of the following year. Each set of OEWS estimates is based on six semi-annual survey samples spanning the prior 3 years. Wages collected in earlier survey panels are updated to the reference date of the estimates based on wage adjustment factors derived from the OEWS survey data using a regression model. The freestanding ESRD facility cost report data that can be analyzed at the time of rulemaking are generally from 2 CYs prior. Specifically, for the proposed wage index presented in Addendum B of this ESRD PPS proposed rule, the BLS OEWS data is derived from surveys conducted from November 2019 through May 2022, and the cost report data generally covers cost reporting periods
Both the ESRD facility cost report data and the BLS OEWS data are more recent than the data used for the IPPS wage index. Additionally, the purpose of using the freestanding ESRD facility cost report data in this proposed methodology would be to establish a national occupational mix for ESRD facilities, which we are calling the NEFOM. We intend to present the NEFOM annually to reflect the latest complete year of cost report data at the time of rulemaking to inform the public of the relative weights assigned to each occupation. Given that freestanding facility cost reports are submitted on a rolling basis, the most recent data would generally be obtained from cost reports beginning in the CY 3 years prior to the CY for which we are setting rates (that is, for this CY 2025 proposed rule, the latest complete year of cost report data are from cost reports beginning in CY 2022). Based on our analysis of prior years' cost report data, we do not anticipate that the national occupational mix would change much from year-to-year. Additionally, we note that the use of a single national occupational mix for all ESRD facilities would limit the impact of changes in employment patterns on the wage index, as all ESRD facilities would be similarly impacted by a change in the NEFOM. As the wage index is a relative value, the main way that a change in the NEFOM would impact an ESRD facility's wage index would be if the CBSA in which that ESRD facility is located has relatively high or low wages for an occupation that experiences growth or shrinkage in the NEFOM. Thus, the main driver in changes from year-to-year under this proposed new wage index methodology likely would be the BLS OEWS data, which, for the final rule, would include survey data as recent as May of the year prior to the rulemaking year.
We note that, at the time of the analysis conducted for this proposed rule, the May 2023 BLS OEWS update was not yet available. As previously discussed, some ESRD facilities' CY 2022 cost reports were not available. Should the proposed new wage index methodology be finalized, we would update the wage index values based on the most recent BLS OEWS data available. We are also proposing to use most recent cost report data available for cost reporting periods beginning in CY 2022 and update the NEFOM accordingly in the final rule. Using the most recent 2022 data available for the calculation of the new ESRD PPS wage index methodology in the final rule would be consistent with our established ESRD PPS wage index methodology of updating ESRD facility wage indices between the proposed and final rules.
We note that our proposed new wage index methodology does use the IPPS wage index to create the ESRD PPS legacy wage index, which is used to standardize the results of the new ESRD PPS wage index methodology. We recognize the concerns we have heard regarding the data lag associated with our use of the IPPS wage index for the ESRD PPS. However, as the ESRD PPS legacy wage index would only be used to calculate a treatment-weighted average of the legacy wage index to standardize the wage index values derived under the proposed new methodology, the proposed new ESRD PPS wage index would continue to reflect the relative differences in area wages based on the more recent BLS OEWS data. Therefore, any effect of any data lag of the ESRD PPS legacy wage index on the proposed new ESRD PPS wage index would be minimal.
The other main concern that interested parties have raised about our current ESRD PPS wage index methodology is that the IPPS wage index is based on hospital cost report data. As previously discussed, interested parties have stated that hospital cost report data is not necessarily the most appropriate source for estimating geographic differences in wages paid by ESRD facilities. These interested parties predominantly point to the different occupational mix employed by ESRD facilities as the main differentiator between inpatient hospitals and ESRD facilities; however, there may also be differences in wages paid for the same occupational labor category in the two settings. Differences in wages within the same occupation could arise from any number of factors, including differences in duties, hours, required experience, or desirability of the position.
Table 3 compares the national average occupational mix and corresponding wages for occupations employed by freestanding ESRD facilities to that of hospitals from IPPS data. The source of average wages used here for ESRD facilities is the BLS OEWS and average IPPS wages are derived from the IPPS occupational survey (Form CMS-10079) as presented in the fiscal year (FY) 2024 IPPS Public Use File (PUF),
We note that the hospital wage data (column F) presented in table 3 presents the wages paid by hospitals to employees, as derived from the IPPS occupational survey data, for the purposes of comparing to the BLS data. This data is used to adjust the hospital average hourly wage, calculated using hospital cost report data, based on the provider-specific occupational mix. This differs from the hospital cost report data used for the IPPS wage index, as that does not break down all wages and related costs by occupation.
Compared to hospitals, ESRD facilities generally use slightly higher proportions of RNs and LPNs and significantly fewer nurse aides and medical aides (column B). Additionally, the freestanding ESRD facility cost reports include additional occupational categories to reflect the labor mix employed by ESRD facilities.
Under our proposal, once we have the calculated wages for each relevant labor category by county (using a crosswalk between MSA, non-MSA and NECTA and counties) and the NEFOM, we would construct the new ESRD PPS wage index using the following steps. These are the general steps which we use when constructing the proposed new ESRD PPS wage index; for a more detailed look at the specific computational steps we execute in the code to calculate the proposed wage index, including steps related to data collection and cleaning, see the supplementary document in Addendum C.
1. We calculate the treatment count-weighted mean hourly wage for each occupation for each CBSA by multiplying the mean hourly wage data from the BLS OEWS by the treatment count for each county within that CBSA and dividing by the total treatment count of all counties within the CBSA. We weight mean hourly wage by treatment count to ensure that the mean hourly wage for the CBSA is proportional with the actual wages paid by ESRD facilities in the CBSA. This avoids a situation where a particularly high or low wage county within a CBSA has no ESRD facilities but still has a large impact on the wage index for that
2. We calculate the ESRD facility mean hourly wage in each CBSA by multiplying the treatment count-weighted mean hourly wage (from step 1) for each occupation for a given CBSA with the corresponding weight of the NEFOM for each occupation and then sum each category's amount to get the total.
3. We calculate the treatment count-weighted mean hourly wage for each occupation at the national level by multiplying the mean hourly wage for the occupation in each CBSA by the treatment count of that CBSA and dividing by the aggregated treatment count nationally.
4. We calculate the national ESRD facility mean hourly wage by multiplying the national mean hourly wage (from step 3) for each occupation by the corresponding weight of the NEFOM for each occupation and then sum each category's amount to get the total.
5. We divide the ESRD facility mean hourly wage for each CBSA by the national ESRD facility mean hourly wage to create a raw wage index level (that is, a wage index that has not been normalized as described in step 6).
6. We multiply the raw wage index level for each CBSA by a treatment weighted average of the CY 2025 ESRD PPS legacy wage index constructed using the established ESRD PPS methodology based on IPPS Medicare cost report data and divide the product by the treatment weighted average of raw wage indices, which equals 1 by construction.
7. We apply the 0.6000 floor to the wage index by replacing any wage index values that fall below 0.6000 with a value of 0.6000, which is the wage index floor for the ESRD PPS as established in the CY 2023 ESRD PPS final rule (87 FR 67166).
After following these steps, we would obtain the wage index values for each CBSA (based on the new OMB delineations as discussed later in this section of the preamble) according to the proposed ESRD PPS wage index methodology described previously. We note that the 5 percent cap in year-over-year decreases in wage index values would be applied for each ESRD facility after the new wage index is calculated based on the proposed methodology for the CBSA in which the ESRD facility is located and, therefore, is not reflected in the wage index value for a CBSA in Addendum A, available on the CMS website at
While developing this new wage index methodology, we have considered several different alternatives regarding both data sources used for the new wage index methodology and construction of the wage index itself. We considered the feasibility of requesting the use of confidential BLS OEWS data. This was one suggestion from the December 2019 TEP. Confidential data would have some benefits over public data, primarily that it would provide greater disaggregation of wages by employer type, such as wages paid by ESRD facilities. Additionally, confidential BLS data could have a timeframe other than the 3-year pooled sample used in the public data, for example using only the most recent year's data. However, we note that the OEWS survey sample is designed to be statistically representative only when all 3 years of the sample are combined, so the use of an alternative or shorter timeframe may not be appropriate. We have determined that the publicly available BLS data would be the most appropriate for our wage index, as it still provides precise estimates of wages and would allow for far better transparency. Additionally, we believe that the inclusion of data from other employers (meaning employers that are not ESRD facilities) would improve the robustness of the methodology, as ESRD facilities compete for labor against these other employers.
When considering the use of BLS data we had to determine which occupation code was appropriate for each occupation in the NEFOM. As discussed previously, for many of these occupations, the corresponding BLS code was straightforward as many of the occupations present in the freestanding ESRD facility cost reports matched a single BLS code. However, for technicians employed by ESRD facilities we gave further consideration to two different BLS codes. As presented in table 1, we are proposing to use code 29-2099 for “Health Technologists and Technicians, All Other” for the construction of the methodology to account for the labor costs of technicians. This is the most appropriate category, as “technicians” in the freestanding ESRD facility cost reports generally refers to dialysis technicians, which do not fall into any of the other BLS codes for health technologists and technicians. Additionally, we note that the SOC uses “dialysis technician” as an illustrative example for code 29-2099.
As an alternative to using a single national occupational mix for ESRD facilities we considered using regional or state-level occupational mixes. The considered alternative would use a similar methodology to the construction of the NEFOM, but with a different occupational mix for each census region or state and would apply the occupational mix in the same way in the construction of the wage index. This is to say, the BLS data for a CBSA would be weighted by the occupational mix for the region or state in which that CBSA is located. This alternative was considered, in part, because of a suggestion from a panelist at the December 2019 TEP who pointed out that different states have different laws regarding staffing requirements for ESRD facilities, which was not reflected in the methodology presented at the TEP. We conducted an analysis comparing a state-level occupational mix wage index to the national occupational mix wage index methodology presented previously. This analysis found some notable differences, including higher wage index values in the pacific census region, but many regions experienced little change. We decided against the use of state-level or regional occupational mixes for three main reasons. The first is that the use of different occupational mixes for different ESRD facilities made the methodology significantly more complicated and difficult to understand. The second is that this methodology made it so that one ESRD facility could be in an area with higher wages for all occupations compared to another ESRD facility but receive a lower wage index value due to having an occupational mix which favored lower-paying occupations. This could be perceived as being inconsistent with the intent of the wage index to recognize differences in ESRD facility resource use for wages specific to the geographic area in which facilities are located (83 FR 56967). Lastly, we are concerned about the possibility that, should we use anything other than a national occupational mix, the state-level or regional occupational mix could be manipulated. This would be especially relevant for states or regions with few ESRD facilities and, therefore, individual ESRD facilities would have an outsized impact on the occupational mix for that state or region. Accordingly, we believe that the use of a single national occupational mix is the most appropriate for this proposed new ESRD facility wage index methodology.
We considered proposing a “phase-in” policy for this proposed wage index methodology change, which could be implemented in addition to the 5 percent cap on wage index decreases. One potential example of a phase-in policy could be a 50/50 blended methodology, where an ESRD facility would receive the average of their wage indices from the proposed new and legacy methodologies for the first year of implementation. However, we decided that such a phase-in policy was unnecessary in light of the 5 percent cap on year-to-year wage index decreases for ESRD facilities. We believe that an additional, or alternative, phase-in policy would further complicate this change. Additionally, a phase-in policy could hurt ESRD facilities that would receive a higher wage-index under the new methodology, which we do not believe would be appropriate, as we believe the new methodology based on BLS data is the best approximation of the labor costs those ESRD facilities face.
We considered setting the NEFOM through rulemaking separately from the routine wage index update. Under this alternative, we would periodically update the NEFOM, for example every 2 years, with potentially more years of freestanding ESRD facility cost report data. This would mean that the NEFOM would be a rounded input in the wage index methodology, rather than a figure precisely calculated as an intermediary step in the methodology. This would slightly simplify the calculation steps and would allow for complete transparency on the NEFOM. However, we have decided to instead derive the FTEs per 1000 treatments for each occupation as the weights as a part of the wage index calculation as that would increase the precision of this calculation. Additionally, given the transparency of the FTE data derived from publicly available cost reports, we can still publish the NEFOM for the coming year in rulemaking alongside the updated wage index; however, we note that the NEFOM we publish would have a lower precision so replications using the published NEFOM as an input may be slightly off. Furthermore, compared to setting the NEFOM through rulemaking less frequently than annually, the proposed methodology to calculate the NEFOM as a part of the wage index methodology annually would be more responsive to national trends in occupational mix for ESRD facilities.
Finally, we considered whether it was most appropriate to use something other than the mean hourly wage for the BLS OEWS data for the construction of the wage index. There are always concerns when using the mean of a data set that the figure could be unduly influenced by outliers. One potential alternative would be to use the median hourly wage data instead. The median hourly wage is available by occupation in publicly available BLS data, and the median is not as influenced by outliers as the mean. We also considered using the geometric mean, instead of arithmetic mean, as that is also less influenced by outliers; however the geometric mean is not provided in publicly available BLS data. Ultimately, we determined that the mean hourly wage is the most appropriate for this new wage index methodology, as any outliers are relevant data points insofar as some ESRD facilities may pay wages significantly higher than the average.
Table 4 is an example of a calculation of the wage index for a hypothetical ESRD facility in a hypothetical CBSA under the proposed new methodology. This CBSA contains three counties, each with a different mean hourly wage and treatment count. Table 4 presents the mean hourly wage and treatment count used in the calculation.
Step 1. Calculate the treatment count-weighted mean hourly wage for each occupation for each CBSA by multiplying the mean hourly wage data from the BLS OEWS by the treatment count for each county within that CBSA and dividing by the total treatment count of all counties within the CBSA.
Step 2. Calculate the ESRD facility mean hourly wage in the CBSA by multiplying the treatment count-weighted mean hourly wage (from step 1) for each occupation for the CBSA with the corresponding weight of the NEFOM for each occupation and sum each category's amount to get the total. The NEFOM for CY 2025 is presented in table 5. For the purposes of ensuring the calculation in this section is as easy to understand as possible we are using the percentage values from the NEFOM rounded to the nearest tenth of a percent. This makes the wage values calculated in this step and step 4 more intuitive as they would represent a weighted average of the wages in the CBSA. We note that in the actual calculation of the wage index, as described in Addendum C, we calculate the number of FTEs per 1000 treatments for each occupation and use those as the weights, so that the weights have a higher level of precision.
Step 3. Calculate the treatment count-weighted mean hourly wage for each occupation at the national level by multiplying the mean hourly wage for the occupation in each CBSA by the treatment count of that CBSA and dividing by the aggregated treatment count nationally.
Step 4. Calculate the national ESRD facility mean hourly wage by multiplying the national mean hourly wage (from step 3) for each occupation by the corresponding weight of the NEFOM for each occupation and sum each category's amount to get the total. Similarly to step 2, we are using the percentages from the NEFOM as weights for the purposes of this example calculation.
Step 5. Divide the ESRD facility mean hourly wage for each CBSA by the national ESRD facility mean hourly wage to create a raw wage index level.
Step 6. Multiply the raw wage index for each CBSA by a treatment weighted average of the CY 2025 ESRD PPS legacy wage index constructed using the established ESRD PPS methodology based on IPPS data and divide the product by the treatment weighted average of raw wage indices (which equals 1 by construction). This is to ensure that the treatment-weighted average of new BLS-based wage indices is the same as the weighted average of the current wage indices (for the purpose of this hypothetical calculation we have used a value of 1.00679).
Step 7. Apply the 0.6000 floor to the wage index by replacing any wage index values which fall below 0.6000 with 0.6000.
The proposed new wage index methodology described previously would be a substantial change from the current approach used by the ESRD PPS to evaluate variations in wages across geographic areas. Compared to the current methodology based on hospital cost report data, this new methodology would use survey data on wages for occupations relevant to furnishing renal dialysis services, which includes data from ESRD facilities and other similar outpatient settings and is weighted according to the average occupational mix of freestanding ESRD facilities. This proposed methodological change, if finalized, would be associated with significant changes in wage index values, and therefore payment amounts, for ESRD facilities. Full impacts for the proposed CY 2025 ESRD PPS wage index, alongside the updated CBSA delineations and rural transition policy discussed in section II.B.2.f of this proposed rule, are presented in table 18 in section VIII.D.5.a of this proposed rule, including application of the 5 percent cap on year-to-year wage index decreases. The 5 percent cap policy would mitigate the impact of the proposed changes to the wage index methodology for CY 2025. Column 3 of table 6 presents the payment impacts associated with only the proposed new wage index methodology without the 5 percent cap on decreased wage indices (with an appropriate wage index budget neutrality adjustment following the established methodology discussed at section II.B.4.b) for the purpose of demonstrating its potential long-term ramifications. For comparison, column 4 of table 6 presents the same payment impacts with the 5 percent cap applied. The figures in these columns represent the expected payment change associated from the move from the CY 2025 ESRD PPS legacy wage index to the proposed new wage index methodology. As an example, this table shows that rural ESRD facilities would see a payment increase of 1.014 (or an increase of 1.4 percent) without the 5 percent cap but only 1.007 (or 0.7 percent) with the 5 percent cap. One major driver of this discrepancy is the fact that changes to the ESRD PPS wage index are budget neutral, so by limiting the negative impact of the change on some facilities through the 5 percent cap, we reduce payments to ESRD facilities not impacted by the cap. Because the 5 percent cap would impact fewer ESRD facilities in each subsequent year by design, column 4 is not a reasonable proxy for long term payment impacts associated with this policy, but rather it represents the expected change in payment to ESRD facilities for CY 2025 as a result of only the proposed wage index methodology change.
Column 3 of table 6 shows the effect that this proposed new wage index methodology would have on ESRD facilities, stratified by facility type,
For comparison, column 4 represents the impacts for CY 2025 with the 5 percent cap applied. As discussed previously, this is not a reasonable proxy for long term payment impacts because (assuming no other changes) the 5 percent cap on wage index decreases would apply to a lower number of ESRD facilities each year until ESRD facilities receive the wage index for the CBSA in which they are located. However, this column does show the impact of applying the 5 percent cap for CY 2025, both for ESRD facilities for which the cap would apply and other ESRD facilities that would receive lower payments due to budget neutrality.
Based on column 3 (as a proxy for long-term impacts), the use of the proposed new wage index methodology would result in a notable increase in payments to rural ESRD facilities and ESRD facilities located in the East South Central census region. Use of the proposed new wage index methodology would result in a notable decrease in payments to the Pacific census region and the United States Pacific Territories (that is, Guam, American Samoa, and the Northern Marianas Islands, which are the only Unites States Pacific Territories with an ESRD facility). Generally, we include the United States Pacific territories together with the Pacific census region, as that is the census region in which these territories are located according to the United States Census Bureau. However, for this analysis examining the effects of CMS' proposed wage index methodology we have opted to separate the territories from the Pacific census region, because we believe that it is important to evaluate the impact on these territories carefully due to their remote geographic location and resulting unique economic situation. Column 4 of table 6 shows how the application of the 5 percent cap mitigates these changes for CY 2025, as ESRD facilities in the United States Pacific territories would have a decrease in payment by a factor of only 0.964 rather than 0.930.
We note that the 5 percent cap on wage index decreases would apply to ESRD facilities that are located in a CBSA (based on CY 2025 CBSA delineations) with a wage index value 5 percent lower than the CY 2024 wage index value for their CBSA (based on CY 2024 CBSA delineations). The impacts detailed in column 3 are presented for the sole purpose of illustrating the potential long-term ramifications of the proposed new wage index methodology once sufficient time has passed such that the 5 percent cap on year-over-year decreases would no longer constrain the overall effect of this proposed new methodology on wage index values.
We have conducted an analysis comparing the hypothetical results of applying this new wage index methodology in past years to the actual ESRD PPS wage index methodology based on the IPPS wage index for those years. We have found that the application of the new wage index methodology consistently yields mean and median wage index values slightly higher than the actual mean and median wage index values used for those years, implying that the wage index resulting from this new methodology is relatively stable. Additionally, we have found that the payment impacts based on facility type did not change much when using data from claim years 2019 through 2022, with most facility types that are projected to receive a payment increase for CY 2025 associated with the proposed new wage index methodology seeing a payment increase in past years. Similarly, most facility types that are projected to receive a payment decrease in CY 2025 associated with the proposed new wage index methodology were found to have received payment decreases in our hypothetical analysis of past years. Therefore, we have determined that this new wage index methodology is relatively stable when analyzing the differences between the new proposed wage index and the ESRD PPS legacy wage index.
For CY 2025, we propose to update the wage indices to account for updated wage levels in areas in which ESRD facilities are located using the proposed new methodology described previously, in subpart b of this section, according to the most recent available data. We believe that the use of this proposed new methodology is appropriate and responds to the feedback we have received from interested parties regarding the limitations of the current wage index. Specifically, the use of BLS OEWS data would allow for this new wage index methodology to be more responsive to differences in ESRD facility wage levels across the country. Additionally, by using occupational mix data from the freestanding ESRD facility cost reports, this proposed methodology would better reflect the actual wage costs incurred by ESRD facilities. We believe that this proposed new methodology would be most appropriate to use for the ESRD PPS due to several reasons specific to ESRD facilities. First, freestanding ESRD facility cost reports contain detailed occupational FTE data, which allows CMS to create a wage index that is tailored to the wage costs faced by ESRD facilities based on their unique staffing needs. Dissimilarities between hospital occupation mix and ESRD facility occupational mix make the use of the IPPS data less appropriate for ESRD facilities. In addition, the ESRD PPS has a lower labor-related share than most other Medicare payment systems.
We recognize that there are several methodological limitations to using a wage index based on publicly available BLS OEWS data. Specifically, this data source lacks information on employee benefits and the full cost of contract labor and includes information from hospitals and other healthcare providers. However, we believe that the benefits of using this proposed new wage index methodology would outweigh these limitations, as the use of BLS OEWS wage data weighted by an occupational mix derived from freestanding ESRD facility cost report data would allow for a wage index that is more representative of the geographic
For CY 2025, we are also proposing to use OMB's most recent CBSA delineations as published in OMB Bulletin No. 23-01, which is based on the data from the 2020 decennial census, for the purposes of the CY 2025 ESRD PPS wage index and rural facility adjustment. This is consistent with our historical practice of updating the CBSA delineations periodically according to the most recent OMB delineations, most recently in the CY 2021 ESRD PPS final rule (85 FR 71430 through 71434). We discuss this policy in greater detail in section II.B.2.f of this proposed rule. For more information on the OMB delineations we refer readers to the OMB Bulletin No. 23-01:
To implement the proposed change in wage index methodology, we are proposing to amend the regulations at 42 CFR 413.196(d)(2) and 413.231(a). Effective January 1, 2025, the amended § 413.196(d)(2) would state that CMS updates on an annual basis “The wage index using the most current wage data for occupations related to the furnishing of renal dialysis services from the Bureau of Labor Statistics and occupational mix data from the most recent complete calendar year of Medicare cost reports submitted in accordance with § 413.198(b).” The amended § 413.231(a) would state that “CMS adjusts the labor-related portion of the base rate to account for geographic differences in the area wage levels using an appropriate wage index (established by CMS) which reflects the relative level of wages relevant to the furnishing of renal dialysis services in the geographic area in which the ESRD facility is located.”
For CY 2025, we propose to update the ESRD PPS wage index to use the most recent BLS OEWS wage data and the most recent CY 2022 freestanding ESRD facility cost report occupational mix and treatment volume data available. At the time the analysis was conducted for this proposed rule, the most recent BLS OEWS wage data available represented May 2022. We propose that if more recent data become available after the development of this ESRD PPS proposed rule and before the publication of the ESRD PPS final rule (for example, the April 2024 release of May 2023 OEWS data, which was published after the analysis performed for this proposed rule), we would use such data, if appropriate, to determine the CY 2025 ESRD PPS wage index in the ESRD PPS final rule. The proposed CY 2025 ESRD PPS wage index is set forth in Addendum A and is available on the CMS website at
We are presenting a version of the current ESRD PPS wage index constructed using our established methodology with the most recent available data, which we are referring to as the ESRD PPS legacy wage index methodology. The purpose of presenting the legacy methodology with modifications is to illustrate an alternative to the proposed new methodology described previously for consideration by interested parties to facilitate comments on this proposed rule. The inclusion of a CY 2025 version of the ESRD PPS legacy wage index methodology allows for interested parties to compare wage index values under the current methodology and proposed new methodology. For the reasons previously discussed, we believe that the proposed new wage index methodology based on BLS data is the most appropriate for ESRD facilities; however, we intend to consider commenters' input on this proposal and the alternative wage index based on the established methodology (updated with the most recent data) when making a determination about the best approach in the final rule.
For this alternative wage index, we would use the ESRD PPS legacy wage index, which is based on the most recent pre-floor, pre-reclassified hospital wage data collected annually under the IPPS. The ESRD PPS legacy wage index values are calculated without regard to geographic reclassifications authorized for acute care hospitals under sections 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that are unadjusted for occupational mix. For CY 2025, the updated wage data are generally for hospital cost reporting periods beginning on or after October 1, 2020, and before October 1, 2021 (FY 2021 cost report data). This CY 2025 version of the legacy wage index methodology includes the updates to OMB's CBSA delineations, as the proposal to update those delineations is separate from the proposal to use the new wage index methodology. Under this possible alternative wage index using the legacy ESRD PPS methodology, we would still use the most recent available OMB CBSA delineations.
Under this alternative methodology, we would update the ESRD PPS legacy wage index to use the most recent hospital wage data. We would update those data if more recent data become available after the publication of this proposed rule and before the publication of the final rule (for example, using a more recent estimate of the IPPS hospital wage data), and we would use such data, if appropriate, to determine the CY 2025 ESRD PPS alternative wage index in the final rule. The alternative CY 2025 ESRD PPS wage index is set forth in Addendum A and is available on the CMS website at
We believe that our proposed new ESRD PPS wage index methodology would more accurately estimate the geographic variation in wages paid by ESRD facilities when compared to the current ESRD PPS wage index based on the IPPS wage index. However, we acknowledge that this proposed new methodology, if finalized, would represent a significant change to the established ESRD PPS wage index methodology, both by changing the data sources and the calculations for the wage index. We are requesting comments on all aspects of the proposed new methodology, including the use of BLS OEWS data for CBSA-level wage estimates, the use of mean hourly wage (rather than median hourly wage), the use of freestanding ESRD facility cost reports for deriving occupational mix weights based on FTEs for each occupation per 1000 treatments as presented in the NEFOM, the use of the ESRD PPS legacy wage index for standardization, and the computational
As previously discussed in this proposed rule, the wage index used for the ESRD PPS is historically calculated using the most recent pre-floor, pre-reclassified hospital wage data collected annually under the IPPS and is assigned to an ESRD facility based on the labor market area in which the ESRD facility is geographically located. We are proposing a new wage index methodology that would similarly be based on the labor market in which an ESRD facility is located. ESRD facility labor market areas are delineated based on the CBSAs established by OMB. In accordance with our established methodology, we have historically adopted through rulemaking CBSA changes that are published in the latest OMB bulletin. Generally, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses.
In the CY 2015 ESRD PPS final rule (79 FR 66137 through 66142), we finalized changes to the ESRD PPS wage index based on the newest OMB delineations, as described in OMB Bulletin No. 13-01
On July 15, 2015, OMB issued OMB Bulletin No. 15-01,
On August 15, 2017, OMB issued OMB Bulletin No. 17-01,
On April 10, 2018, OMB issued OMB Bulletin No. 18-03
In the July 16, 2021,
We believe it is important for the ESRD PPS to use, as soon as reasonably possible, the latest available labor market area delineations to maintain a more accurate and up-to-date payment system that reflects the reality of population shifts and labor market conditions. We believe that using the most current OMB delineations would increase the integrity of the ESRD PPS wage index system by creating a more accurate representation of geographic variations in wage levels, especially given the proposed new wage index methodology discussed previously. We have carefully analyzed the impacts of adopting the new OMB delineations and find no compelling reason to delay implementation. Therefore, we are proposing to adopt the updates to the OMB delineations announced in OMB Bulletin No. 23-01 effective for CY 2025 under the ESRD PPS for use in determining both the wage index and the rural adjustment for ESRD facilities. This would be implemented along with the new ESRD PPS wage index methodology, if finalized, or along with the alternative ESRD PPS legacy wage
As previously discussed, we finalized a 5 percent permanent cap on any decrease to a provider's wage index from its wage index in the prior year in the CY 2023 ESRD PPS final rule (87 FR 67161). We are not proposing any additional transition policy for the CY 2025 wage index as we believe the 5 percent cap effectively mitigates the negative impact of large wage index decreases for an ESRD facility in a single year. In addition, we are proposing to phase out the rural adjustment for ESRD facilities that are transitioning from rural to urban based on these CBSA revisions, as discussed in section II.B.2.f.(2) of this proposed rule. For a further discussion of changes to OMB's CBSA delineations, including a list of changes to specific CBSAs, see the FY 2025 IPPS proposed rule (89 FR 36139).
In the CY 2016 ESRD PPS final rule (80 FR 69001), we established a policy to provide a 0.8 percent payment adjustment to the base rate for ESRD facilities located in a rural area. This adjustment was based on a regression analysis, which indicated that the per diem cost of providing renal dialysis services for rural facilities was 0.8 percent higher than that of urban facilities after accounting for the influence of the other variables included in the regression. This 0.8 percent adjustment has been part of the ESRD PPS each year since it was finalized beginning for CY 2016, and its inclusion in the ESRD PPS is codified at § 413.233.
As previously discussed in this proposed rule, we are proposing a methodological change to the ESRD PPS wage index methodology as well as changes to the CBSA delineations. In the CY 2023 ESRD PPS final rule, we finalized a policy to cap year-to-year decreases in the wage index for any ESRD facility at 5 percent (87 FR 67161). The primary purpose of this change was to mitigate the negative effect associated with an ESRD facility being reclassified into a lower wage index CBSA as a result of changes in OMB's most recent CBSA delineations. We anticipate that the proposed change to the CBSA delineations and the changes to the wage index methodology, if finalized, would lead to numerous ESRD facilities having a significant decrease in wage index value in CY 2025 compared to CY 2024. As previously discussed, the adoption of OMB Bulletin No. 23-01 would determine whether an ESRD facility is classified as urban or rural for purposes of the rural facility adjustment in the ESRD PPS. Although the rural facility adjustment is not directly related to the wage index, the application of both is determined by the CBSA in which an ESRD facility is located and, therefore, is potentially subject to significant changes associated with the new CBSA delineations. It is reasonable to conclude that these proposed shifts in the CBSA delineations, in combination with the wage index methodological changes proposed in this proposed rule, could lead to a year-over-year decrease in payment greater than what a 5 percent decrease to the wage index would cause even if the decrease in the wage index value alone would be less than 5 percent. To mitigate the scope of changes that would impact ESRD facilities in any single year, we are proposing to implement a 3-year phase out of the rural facility adjustment for ESRD facilities that are located in a CBSA that was categorized as rural in CY 2024 and is recategorized as urban in CY 2025, as a result of the updates to the CBSA delineations associated with the proposed adoption of OMB Bulletin No. 23-01.
Overall, we believe implementing updated OMB delineations would result in the rural facility adjustment being applied where it is appropriate to adjust for higher costs incurred by ESRD facilities in rural locations. However, we recognize that implementing these proposed changes, if finalized, would have different effects among ESRD facilities and that the loss of the rural facility adjustment could lead to some hardship for ESRD facilities that had anticipated receiving the rural facility adjustment in CY 2025. Therefore, we believe it would be appropriate to consider whether a transition period should be used to implement these proposed changes.
For ESRD facilities located in a county that transitioned from rural to urban in OMB Bulletin 23-01, we considered whether it would be appropriate to phase out the rural facility adjustment for affected ESRD facilities. Adoption of the updated CBSAs in OMB Bulletin 23-01, if finalized as proposed, would change the status of 44 ESRD facilities currently designated as “rural” to “urban” for CY 2025 and subsequent CYs. As such, these 44 newly urban ESRD facilities would no longer receive the 0.8 percent rural facility adjustment. Consistent with the rural transition policy proposed for Inpatient Psychiatric Facilities (IPFs) and Inpatient Rehabilitation Facilities (IRFs) for FY 2025 (89 FR 23188, 89 FR 22267 through 22268) we are proposing a 3-year, budget neutral phase-out of the rural facility adjustment for ESRD facilities located in the 54 rural counties that would become urban under the new OMB delineations, given the potentially significant payment impacts for these ESRD facilities. We believe that a phase-out of the rural facility adjustment transition period for these 44 ESRD facilities would be appropriate, because we expect these ESRD facilities would experience a steeper and more abrupt reduction in their payments compared to other ESRD facilities. We are proposing to adopt these new CBSA delineations in a year in which we are also proposing substantial methodological changes to our wage index. While these proposed changes, if finalized, would increase payment accuracy across the ESRD PPS, we also recognize that some ESRD facilities could lose the rural facility adjustment and receive a significantly lower wage index value in the same year. We believe that it is appropriate for this proposed transition policy to be budget-neutral compared to ending the rural adjustment for these facilities in CY 2025 because it is an extension of the rural facility adjustment, which is implemented budget-neutrally, and a result of the change in CBSA delineations, which is proposed to be implemented budget-neutrally alongside the wage index changes. The reasoning behind this proposal is similar to the reasoning behind the 5 percent cap on year-to-year decreases in wage index values which was finalized in the CY 2023 ESRD PPS final rule (87 FR 67161), as it would ameliorate unexpected negative impacts to certain ESRD facilities. This rural phase-out in combination with the 5 percent cap policy would best reduce the negative effects on any single ESRD facility resulting from changes to the CBSA delineations. Therefore, we are proposing to phase out the rural facility adjustment for these facilities to reduce the impact of the loss of the CY 2024 rural facility adjustment of 0.8 percent over CYs 2025, 2026, and 2027, consistent with the similar IPF and IRF proposals previously discussed. This policy would allow ESRD facilities that are classified as rural in CY 2024 and would be classified as urban in CY 2025 to receive two-thirds of the rural facility adjustment for CY 2025, or a 0.53 percent adjustment. For CY 2026, these ESRD facilities would receive one-third of the rural facility adjustment, or a 0.27
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS include a payment adjustment for high cost outliers due to unusual variations in the type or amount of medically necessary care, including variability in the amount of erythropoiesis stimulating agents (ESAs) necessary for anemia management. Some examples of the patient conditions that may be reflective of higher facility costs when furnishing dialysis care are frailty and obesity. A patient's specific medical condition, such as secondary hyperparathyroidism, may result in higher per treatment costs. The ESRD PPS recognizes that some patients require high cost care, and we have codified the outlier policy and our methodology for calculating outlier payments at § 413.237.
Section 413.237(a)(1) enumerates the following items and services that are eligible for outlier payments as ESRD outlier services: (i) Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (ii) Renal dialysis laboratory tests that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (iii) Renal dialysis medical/surgical supplies, including syringes, used to administer renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (iv) Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, covered under Medicare Part D, including renal dialysis oral-only drugs effective January 1, 2025; and (v) Renal dialysis equipment and supplies, except for capital-related assets that are home dialysis machines (as defined in § 413.236(a)(2)), that receive the transitional add-on payment adjustment as specified in § 413.236 after the payment period has ended.
In the CY 2011 ESRD PPS final rule (75 FR 49142), CMS stated that for purposes of determining whether an ESRD facility would be eligible for an outlier payment, it would be necessary for the ESRD facility to identify the actual ESRD outlier services furnished to the patient by line item (that is, date of service) on the monthly claim. Renal dialysis drugs, laboratory tests, and medical/surgical supplies that are recognized as ESRD outlier services were specified in Transmittal 2134, dated January 14, 2011.
Under § 413.237, an ESRD facility is eligible for an outlier payment if its imputed (that is, calculated) MAP amount per treatment for ESRD outlier services exceeds a threshold. In past years, the MAP amount has reflected the average estimated expenditure per treatment for services that were or would have been considered separately billable services prior to January 1, 2011. The threshold is equal to the ESRD facility's predicted MAP per treatment plus the fixed dollar loss (FDL) amount. As described in the following paragraphs, the ESRD facility's predicted MAP amount is the national adjusted average ESRD outlier services MAP amount per treatment, further adjusted for case-mix and facility characteristics applicable to the claim. We use the term “national adjusted average” in this section of this proposed rule to more clearly distinguish the calculation of the average ESRD outlier services MAP amount per treatment from the calculation of the predicted MAP amount for a claim. The average ESRD outlier services MAP amount per treatment is based on utilization from all ESRD facilities, whereas the calculation of the predicted MAP amount for a claim is based on the individual ESRD facility and patient characteristics of the monthly claim. In accordance with § 413.237(c), ESRD facilities are paid 80 percent of the per treatment amount by which the imputed MAP amount for outlier services (that is, the actual incurred amount) exceeds this threshold. ESRD facilities are eligible to receive outlier payments for treating both adult and pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule and codified in § 413.220(b)(4), using 2007 data, we established the outlier percentage—which is used to reduce the per treatment ESRD PPS base rate to account for the proportion of the estimated total Medicare payments under the ESRD PPS that are outlier payments—at 1.0 percent of total payments (75 FR 49142 through 49143). We also established the FDL amounts that are added to the predicted outlier services MAP amounts. The outlier services MAP amounts and FDL amounts are different for adult and pediatric patients due to differences in the utilization of separately billable services among adult and pediatric
Lastly, in the CY 2023 ESRD PPS final rule, we finalized an update to the outlier methodology to better target 1.0 percent of total Medicare payments (87 FR 67170 through 67177). We explained that for several years, outlier payments had consistently landed below the target of 1.0 percent of total ESRD PPS payments (87 FR 67169). Commenters raised concerns that the methodology we used to calculate the outlier payment adjustment since CY 2011 results in underpayment to ESRD facilities, as the base rate has been reduced by 1.0 percent since the establishment of the ESRD PPS to balance the outlier payment (85 FR 71409, 71438 through 71439; 84 FR 60705 through 60706; 83 FR 56969). In response to these concerns, beginning with CY 2023, we began calculating the adult FDL amounts based on the historical trend in FDL amounts that would have achieved the 1.0 percent outlier target in the 3 most recent available data years. We stated in the CY 2023 ESRD PPS final rule that we would continue to calculate the adult and pediatric MAP amounts for CY 2023 and subsequent years following our established methodology. In that same CY 2023 ESRD PPS final rule, we provided a detailed discussion of the methodology we use to calculate the MAP amounts and FDL amounts (87 FR 67167 through 67169).
For CY 2025, we are proposing several methodological and policy changes to the ESRD PPS outlier policy to address a number of concerns that interested parties have raised in recent years. Although we note that the 1.0 percent outlier target was achieved in CY 2023, it was not achieved in the majority of the years since the establishment of the ESRD PPS in 2011. We expect that each of the proposed changes would support the ability of the ESRD PPS to continue targeting outlier payments at 1.0 percent in CY 2025 and subsequent years. We discuss each of these proposed changes in detail in the following sections.
In the CY 2011 ESRD PPS final rule we finalized a policy that only renal dialysis services that were or would have been separately billable prior to the inception of the ESRD PPS would be eligible for the outlier payment. In the CY 2011 ESRD PPS proposed rule we explained that we believed that any unusual variation in the cost of the renal dialysis services comprising the base rate under the ESRD PPS would likely to be due to variation in the items and services that were, at that time, separately billable under Part B or renal dialysis service drugs and biological products that were then covered under Part D (74 FR 49988). We received some comments at that time that requested CMS consider alternative ways to determine outlier eligibility, including expanding eligibility to all renal dialysis services. However, we noted that we did not have adequate data at that time to include all Composite Rate Services (that is, renal dialysis services included in the composite payment system established under section 1881(b)(7) of the Act and the basic case-mix adjusted composite payment system established under section 1881(b)(12) of the Act, as defined in regulation at § 413.171) in the outlier calculation (74 FR 49989, 75 FR 49135).
In the CY 2019 ESRD PPS proposed rule we issued a comment solicitation on the potential expansion of outlier payments to composite rate supplies, drugs, and biological products (83 FR 34332). In this RFI, we detailed that such a change could promote appropriate payment for composite rate drugs once the TDAPA period has ended. Commenters' responses to this comment solicitation were mixed (83 FR 56969 through 56970). One commenter expressed that such a change would promote and incentivize the development of innovative new therapies and devices to treat the highly vulnerable ESRD adult and pediatric patient populations. Some commenters responded specifically regarding the TDAPA that extending availability of outlier payments would be particularly important when no additional money is being added to the base rate for the drug, as is the case with most drugs and biological products receiving the TDAPA. However, some commenters, including MedPAC, did not agree that such an expansion of the outlier eligible services would improve care, generally indicating that expanding the list of ESRD outlier services would hamper the outlier payment's functionality. One commenter stated that the purpose of the outlier adjustment was to pay for unusually costly patients, not new drugs and biological products, which the commenter felt the outlier payment was unable to do adequately. MedPAC commented that an outlier policy should act as a stop-loss insurance for medically necessary care, and outlier payments are needed when the ESRD PPS' payment adjustments do not capture all of the factors affecting providers' costs of delivering care. To that end, MedPAC stated that to develop an effective outlier policy, CMS must first develop accurate patient-level and facility-level payment adjustments. MedPAC further cautioned that should CMS expand the list of eligible ESRD outlier services, we should be clear as to what would qualify for the outlier payment.
In subsequent years, we took steps to expand the outlier policy to include certain potentially costly renal dialysis services that would have been included in the composite rate prior to the ESRD PPS. In the CY 2020 ESRD PPS final rule we finalized that any new and innovative renal dialysis equipment or supply would be eligible for the outlier adjustment after the end of the TPNIES period, regardless of whether it would have been separately billable prior to 2011 (84 FR 60697). In that rule, we explained that we believed allowing these items to be outlier eligible after the end of the TPNIES period would allow for these new and innovative supplies to be competitive with the other equipment and supplies also accounted for in the ESRD PPS base rate by establishing a level playing field where products could gain market share by offering the best practicable combination of price and quality (84 FR 60693). In the CY 2021 ESRD PPS final rule, we finalized that capital-related assets that are home dialysis machines will not become ESRD outlier services at the end of the TPNIES payment period (85 FR 71399). We explained that as assets, capital-related home dialysis machines are distinct from operating expenses such as the disposable supplies and leased equipment with no conveyed ownership rights. Unlike assets, these latter items are generally accounted for on a per patient basis and therefore, when used in excess of the average, constitute outlier use, which makes them eligible for outlier payments (85 FR 71424).
The definition of ESRD outlier services is codified at § 413.237(1)(a). Currently, drugs and biological products that were or would have been paid under the composite rate are not considered ESRD outlier services, and
In the CY 2024 ESRD PPS final rule (88 FR 76391), we finalized a policy to pay, beginning for CY 2024, a post-TDAPA add-on payment adjustment for any new renal dialysis drug or biological product that is considered included in the ESRD PPS base rate that has previously been paid for using the TDAPA under § 413.234(c)(1). This post-TDAPA add-on payment adjustment generally will be applied for a period of 3 years following the end of the TDAPA period for those products. We finalized that the post-TDAPA add-on payment adjustment amount will be calculated based on the most recent available 12 months of claims data and the latest available full calendar quarter of average sales price (ASP) data (88 FR 76396). We explained that we divide the total expenditure of the new renal dialysis drug or biological product by the total number of ESRD PPS treatments furnished during the same 12-month period. In addition, we finalized that we adjust the post-TDAPA add-on payment adjustment amount paid on claims by the patient-level case-mix adjustment factors; accordingly, we apply a reduction factor to the post-TDAPA add-on payment adjustment amount to account for the application of the patient-level case-mix adjustment factors. We codified these policies by revising § 413.234(c)(1)(i) and adding regulations at § 413.234(b)(1)(iii), (c)(1)(ii), (c)(3), and (g) that describe the post-TDAPA add-on payment adjustment and the calculation we use to determine the post-TDAPA add-on payment adjustment amount. In addition, we amended § 413.230 by adding reference to the post-TDAPA add-on payment adjustment in the calculation of the ESRD PPS per treatment payment amount.
In the same CY 2024 ESRD PPS final rule, we summarized comments regarding the outlier policy as it pertains to the post-TDAPA add-on payment adjustment (88 FR 76396). One commenter pointed out that the CY 2024 ESRD PPS proposed rule did not indicate whether the ESRD PPS outlier adjustment would apply to products for which a post-TDAPA add-on payment adjustment is calculated. In response, CMS stated that under current policy, after the end of the TDAPA period, a drug or biological product is considered an eligible outlier service only if it meets the requirements of § 413.237(a)(1). We clarified that any renal dialysis drug or biological product included in the calculation of the post-TDAPA add-on payment adjustment would be considered an eligible ESRD outlier service only if it meets the requirements of § 413.237(a)(1). However, we further clarified that under current policy, Korsuva®, the only renal dialysis drug with a TDAPA period ending in CY 2024, would not be considered an eligible ESRD outlier service after the end of its TDAPA period, because it is a substitute for diphenhydramine hydrochloride, which was included in the composite rate prior to 2011, and therefore does not meet the requirements of § 413.237(a)(1) (that is, it would not have been, prior to January 1, 2011, separately billable under Medicare Part B).
Most recently, we have heard concerns from interested parties that excluding drugs and biological products that are substitutes for—or are used to achieve the same effect as—composite rate drugs and biological products from the definition of ESRD outlier services could limit the ability of the ESRD PPS outlier adjustment to appropriately recognize the drivers of cost for renal dialysis services. We considered these concerns, as well as the comments we received in response to prior rulemaking, to develop proposed changes to the definition of ESRD outlier services.
We are proposing to change the definition of ESRD outlier services at § 413.237(a)(1) to include drugs and biological products that were or would have been included in the composite rate prior to the establishment of the ESRD PPS. We note that this proposal would expand outlier eligibility to longstanding drugs and biological products that were historically included in the composite rate, as well as newer drugs and biological products that are currently included in the calculation of the post-TDAPA add-on payment adjustment. As discussed in section II.B.3.c of this proposed rule, we are proposing technical changes to the calculation of outlier payments that would appropriately account for the post-TDAPA add-on payment adjustment for ESRD outlier services that are drugs and biological products.
First, we considered the original intent behind the policy to limit outlier payments to drugs that were or would have been separately billable prior to 2011, which was that these drugs were likely the main drivers of the variation in the costs of treatment (74 FR 49988). We continue to believe that an important aspect of the outlier adjustment should be its ability to target ESRD cases that are unusually costly. If the outlier adjustment methodology failed to recognize the main drivers of variation in the costs of ESRD treatment, then it could result in cases that are not unusually costly qualifying for the outlier adjustment, which would mean the impact of the outlier adjustment would be diluted. As we noted earlier in this proposed rule, many of the responses to the comment solicitation in the CY 2019 ESRD PPS proposed rule expressed concerns that expanding the scope of ESRD outlier services would potentially dilute the impact of the outlier adjustment. We considered the potential impact of expanding the definition of ESRD outlier services to include additional drugs and biological products not currently included. We agree with the commenters who noted that the purpose of the outlier payment is not to pay for new drugs and biological products (83 FR 56969). Rather, as we discussed in the CY 2011 ESRD PPS final rule (75 FR 49134), CMS established the current outlier policy, including the 1.0 percent outlier target, because it struck an appropriate balance between our objective of paying an adequate amount for the most costly, resource-intensive patients while providing an appropriate level of payment for those patients who do not qualify for outlier payments. Under our current policy, new renal dialysis drugs and biological products that are paid for using the TDAPA are not considered
We are not proposing to expand outlier eligibility to drugs and biological products that are paid for using the TDAPA during the TDAPA payment period, as the TDAPA amount is based on the full price (100 percent of ASP) for the amount of such drugs that is utilized and billed on the claim.
We considered only expanding the definition of ESRD outlier services to include drugs and biological products that were previously paid for using the TDAPA. As commenters have noted, new renal dialysis drugs and biological products are likely to be drivers of cost, because these drugs are typically more expensive. We recognized the importance of supporting access to new renal dialysis drugs and biological products under the ESRD PPS through the establishment of the post-TDAPA add-on payment adjustment beginning in CY 2024 (88 FR 76391). We explained in the CY 2024 ESRD PPS final rule that we agreed with commenters who expressed concerns that the ESRD PPS' current mechanisms may not fully account for the costs of these new drugs (88 FR 76388). We noted that several commenters stated that the outlier adjustment and the ESRDB market basket updates cannot adequately account for these costs, and several organizations noted that if additional renal dialysis drugs and biological products with significant costs were incorporated into the outlier payment calculation, the threshold to qualify for outlier payments would increase dramatically, thus adversely affecting access to products traditionally eligible for the outlier payment adjustment. We described comments which expressed that this increase in the outlier threshold may also raise health equity concerns because, as we noted in the CY 2023 ESRD PPS final rule (87 FR 67170 through 67171), the outlier adjustment protects access for beneficiaries whose care is unusually costly. We recognized that if the outlier threshold were to increase significantly due to significant use of a new renal dialysis drug or biological product after the end of the TDAPA period, then ESRD facilities might be incentivized to avoid treating costlier beneficiaries.
We believe it would be appropriate for the definition of ESRD outlier services to include all drugs and biological products that previously were paid for using the TDAPA. The inclusion of these drugs and biological products would help ensure appropriate payment when a patient's treatment is exceptionally expensive due to an ESRD facility furnishing such drugs or biological products to the patient whose treatment requires them. In the CY 2011 ESRD PPS proposed rule, we explained that significant variations in formerly separately billable items and services could impair access to appropriate care, as an ESRD facility may have a disincentive to provide adequate treatment to those ESRD patients likely to have significantly higher than average costs (74 FR 49988). We believe ESRD facilities may face similar disincentives for furnishing drugs and biological products that previously received payment under the TDAPA. We believe that this change would also align with the statutory authority for the outlier adjustment under section 1881(b)(14)(D)(ii) of the Act by protecting patients' access to medically necessary care through a payment adjustment that more fully recognizes unusual variations in the type or amount of such care. Specifically, we believe this change would encourage ESRD facilities to take on ESRD patients who would potentially require expensive new drugs and biological products, promoting health equity for these patients who require costlier care. Additionally, the technical changes we are proposing in section II.B.3.c of this proposed rule would limit the impact of such drugs and biological products on the outlier threshold calculation, thereby enabling the ESRD PPS outlier adjustment to continue to protect access for beneficiaries whose care is unusually costly.
In light of the past comments described earlier in this section, we further considered whether expanding eligibility to all renal dialysis drugs and biological products that are Composite Rate Services, as defined at § 413.171, would be appropriate. As we have previously stated, the purpose of the outlier adjustment is to protect access for beneficiaries whose care is unusually costly. Although we continue to expect that the main drivers of cost would be drugs and biological products that were previously separately billable under Part B or Part D, or were previously paid for using the TDAPA, we nevertheless recognize that some patients could require higher utilization of composite rate drugs and biological products, which may result in the overall cost of their renal dialysis care being unusually high. For example, as noted in section II.B.3.e of this proposed rule, our analysis has identified that certain composite rate drugs are significant drivers of cost for pediatric patients, and therefore the proposed inclusion of those drugs as ESRD outlier services would improve the ability of the ESRD PPS outlier adjustment to target payment for pediatric patients whose care is exceptionally costly. Including composite rate drugs and biological products in the calculation of the outlier adjustment could appropriately support care for such ESRD patients, because payments under the outlier adjustment would better align with resource use.
We also considered the comments from MedPAC in response to the CY 2019 ESRD PPS proposed rule. Specifically, MedPAC stated that to develop an effective outlier policy, CMS must first develop accurate patient-level and facility-level payment adjustments. As we stated in the CY 2024 ESRD PPS final rule, interested parties have encouraged CMS to develop a patient cost model that is based on a single patient-level cost variable that accounts for all composite rate and formerly separately billable services (88 FR 76399). We finalized the collection of time on machine data, beginning for CY 2025, which we stated would allow for a higher proportion of composite rate costs to be allocated to patients with longer renal dialysis treatment times, and ultimately inform CMS refinements to existing patient-level adjusters,
We do not agree that the proposed inclusion of composite rate drugs and biological products would dilute the impact of the outlier adjustment, as some commenters in response to the CY 2019 ESRD PPS proposed rule suggested. Rather, our analysis indicates that the inclusion of these drugs and biological products would appropriately recognize the situations when the provision of these services is unusually costly, which we estimate would increase the amount of outlier payment per outlier-eligible claim, thereby more effectively protecting access for beneficiaries whose care is exceptionally costly. As discussed in section II.B.3.e. of this proposed rule, if we made no changes to our outlier methodology or the definition of ESRD outlier services for CY 2025, the average outlier payment for outlier-eligible cases among pediatric patients would be $25.02, and the average outlier payment for adult patients would be $53.45. Under the proposed changes to outlier eligibility, the average outlier payment for pediatric and adult patients would increase to $73.24 and $57.16, respectively. Furthermore, as discussed later in section II.B.3.e of this proposed rule, the inclusion of composite rate drugs and biological products would increase the pediatric MAP amount by a large amount, reflecting the utilization of certain high-cost composite rate drugs. Although the proposed CY 2025 adult MAP amount is lower than the final CY 2024 adult MAP amount, we note that the proposed adult MAP amount for CY 2025 is approximately $0.79 higher than it would be absent the proposed policy changes in this rule, which demonstrates that the inclusion of composite rate drugs and biological products would result in a higher MAP amount for adults.
In summary, the inclusion of composite rate drugs and biological products as ESRD outlier services would include more costs in the calculation of the ESRD PPS outlier adjustment for each case. As a result, fewer claims would qualify for outlier payments, but the amount of outlier payment per claim would be higher. Therefore, rather than diluting the impact of the outlier adjustment, these proposed changes would increase the impact of the outlier adjustment.
We are proposing to amend the language at 42 CFR 413.237 by adding a new paragraph (a)(1)(vii), which would add to the list of renal dialysis services defined as ESRD outlier services the following: “Renal dialysis drugs and biological products that are Composite Rate Services as defined in § 413.171.”
As we discussed in the CY 2023 ESRD PPS final rule (87 FR 67169), a claim is eligible for outlier payment when its imputed MAP amount exceeds the sum of the predicted MAP amount and the fixed dollar loss threshold. The predicted MAP amount for a claim is based on the national average MAP amount, adjusted by the case-mix adjustment factors that apply for that claim's patient-level and facility-level characteristics. As a result, when a claim's adjustment factors increase the payment amount per treatment, the claim's predicted MAP is also increased. This is because we expect that more complex patients would require a higher amount of spending for outlier services. However, this higher expected cost is recognized through a higher per treatment payment amount. In other words, a more complex patient must have even higher costs than are already accounted for in the adjustment factors compared to a less complex patient to be considered unusually costly. By increasing the predicted MAP based on the case-mix adjustment factors, the ESRD PPS outlier policy ensures that only cases that are unusually costly are considered for outlier payment.
As previously discussed in this proposed rule, we finalized a post-TDAPA add-on payment adjustment in the CY 2024 ESRD PPS final rule. The post-TDAPA add-on payment adjustment for certain new renal dialysis drugs and biological products is generally applied for 3 years after the end of the TDAPA period (88 FR 76388 through 76397). The amount of this post-TDAPA add-on payment adjustment that is applied to an ESRD PPS claim is adjusted by any applicable patient-level case-mix adjustments under § 413.235, and this adjusted amount is added to the payment amount for each ESRD PPS treatment billed. We explained in the CY 2024 ESRD PPS final rule that during this 3-year post-TDAPA add-on payment period, a drug or biological product would be eligible for the outlier add-on payment if it met all of the other criteria for the outlier payment (88 FR 76396). The only drug or biological product which was set to end its TDAPA period in CY 2024 (and therefore would receive the post-TDAPA add-on payment adjustment that year) was Korsuva®, which is a substitute for a composite rate drug and, therefore, not outlier eligible under existing § 413.237(a)(1) (88 FR 76396). Therefore, we did not propose any changes to the ESRD PPS outlier methodology to account for the post-TDAPA add-on payment adjustment in the CY 2024 ESRD PPS proposed rule as that would not have affected payments for CY 2024.
As noted previously, we are proposing to expand outlier eligibility to include renal dialysis drugs and biological products that are Composite Rate Services as defined in § 413.171. This would mean that new drugs and biological products that are included in the calculation of the post-TDAPA add-on payment adjustment amount would become outlier eligible after the end of the TDAPA period, regardless of whether they are substitutes for composite rate drugs or biological products.
We are also proposing changes to the ESRD PPS outlier methodology to account for any future drugs and biological products which are outlier eligible during the post-TDAPA period. We propose to add the case-mix adjusted post-TDAPA add-on payment adjustment amount to the predicted MAP for a patient. This is appropriate because the post-TDAPA add-on payment adjustment amount represents average utilization of a drug or biological product, and is added to the payment amount, adjusted by the case-mix adjusters for the patient. This would prevent duplicate payment for these drugs and biological products by accounting for the portion of the cost for these drugs or biological products which is included in the ESRD PPS bundled payment. We note that this proposed change would not affect the calculation of the imputed MAP for a claim, because a claim's imputed MAP would include the actual utilization of the drug or biological product that is included in the calculation of the post-TDAPA add-on payment adjustment, if that drug or biological product is billed on the claim.
We considered proposing to modify the average MAP amount to account for outlier eligible drugs and biological products that are already included in the calculation of the post-TDAPA add-
For CY 2025, the impact of this technical modification would be a small increase to the pediatric and adult FDL amounts, due to the small post-TDAPA add-on payment adjustment amount calculated for each quarter of CY 2025, as discussed in section II.B.6 of this proposed rule. Without this proposed methodological change, the pediatric FDL amount would increase by $0.68. Likewise, the adult FDL amount would increase by $0.89. This proposed methodological change would avoid those increases, resulting in the proposed CY 2025 adult and pediatric MAP and FDL amounts shown in table 7 of this proposed rule. Although the effect would be small for CY 2025, we note that the proposed increase would be larger in potential future situations when utilization of a drug or biological product during the post-TDAPA payment period could be higher.
In the CY 2011 ESRD PPS final rule we finalized our ESRD PPS outlier methodology, which included our methodology for updating data from past years to the CY for which CMS is establishing payment rates (75 FR 49134). In the CY 2023 ESRD PPS final rule, we finalized an update to the outlier methodology to better target 1.0 percent of total Medicare payments (87 FR 67170 through 67177) by prospectively calculating the adult FDL amounts based on the historical trend in FDL amounts that would have achieved the 1.0 percent outlier target in the 3 most recent available data years. In that final rule we also clarified our longstanding methodology for updating data from prior years for the purposes of the outlier calculations (87 FR 67167). For drugs and biological products, we use a blended 4-quarter moving average of the ESRDB market basket price proxies for pharmaceuticals to inflate drug prices to the CY for which CMS is establishing payment rates. For laboratory tests, we inflate laboratory test prices to the CY for which CMS is establishing payment rates using a CPI forecast to estimate changes for years in which a new data reporting period will take place for the purpose of setting Clinical Laboratory Fee Schedule (CLFS) rates.
In the CY 2023 ESRD PPS final rule (87 FR 67173), we noted that MedPAC supported the proposed revisions to the FDL methodology, but also urged CMS to refine its approach for applying the pricing data that the agency uses to project future spending for outlier services, particularly for drugs. Specifically, MedPAC suggested CMS use a drug price inflation factor based on ASP values and noted that the ASP data that CMS uses to determine facilities' actual outlier payments might be a more accurate data source on drug prices than the ESRDB market basket pharmaceutical price proxies that are currently used.
As discussed in the following sections, we have undertaken analysis of prices for ESRD outlier services and are proposing several technical changes to the inflation factors.
As described earlier, we use a blended 4-quarter moving average of the ESRDB market basket price proxy for Pharmaceuticals to inflate drug prices to the upcoming CY for the purpose of estimating spending for outlier drugs and biological products in that CY. Historically, this 4-quarter moving average is a positive factor, meaning that our longstanding methodology for modeling outlier spending amounts assumes that prices for ESRD outlier drugs and biological product will increase. For example, the current projection of the CY 2025 price growth for ESRD outlier drugs and biological products, based on the ESRDB market basket price proxy for Pharmaceuticals for CY 2025, is 1.9 percent, based on the IGI 1st quarter 2024 forecast with historical data through the 4th quarter of 2023.
To compare the actual changes in prices for ESRD outlier drugs and biological products against the assumed rate of change derived from the ESRDB market basket price proxies, we constructed an index of prices for ESRD outlier drugs and biological products. As previously discussed in section II.B.3.b of this proposed rule, we are proposing to expand the definition of ESRD outlier services to include renal dialysis drugs and biological products that were or would have been included in the composite rate prior to the establishment of the ESRD PPS. Accordingly, our constructed drug price index included these drugs and biological products as well as drugs and biological products that have historically been included in the definition of ESRD outlier services.
Because the list of ESRD outlier drugs and biological products changes over time, we are proposing to derive a chained Laspeyres price index of the drugs and biological products included in the definition of the ESRD outlier services. A chained Laspeyres price index does not require a fixed basket of drugs and biological products during the observation window. We constructed and then trended forward the year-over-year change in price index levels for this outlier drug index to calculate a projected inflation factor for ESRD outlier drugs and biological products for CY 2025, using the following steps:
Using this methodology, we calculated a projected inflation factor of −0.7 percent, meaning that prices for ESRD outlier drugs and biological products are projected to be 0.7 percent lower in CY 2025 relative to the prices of the ESRD outlier drugs and biological products in than in CY 2024. We note that our analysis of year-over year changes in prices for ESRD outlier drugs and biological products shows a consistent, downward trend in prices, which stands in contrast to the positive inflation factors we have historically used to model outlier payments. As a result, our modeling of outlier spending in prior years has assumed that outlier prices would increase, when the ASP data shows that overall the prices have decreased.
Based on the results of our analysis, we believe that applying an inflation factor based on the actual change in prices for ESRD outlier drugs and biological products would enable the ESRD PPS outlier adjustment to better target 1.0 percent of outlier payments in CY 2025, because such an inflation factor would better reflect the observed historical trend in spending and utilization for such drugs and biological products. Although we have historically used the ESRDB market basket price proxy for Pharmaceuticals as the basis of our inflation assumptions for outlier modeling, and we believe that market basket price proxies would continue to be a reasonable and technically appropriate source for such assumptions, we note that the market basket price proxies serve a distinctly different purpose than the inflation factors. As we explained in the CY 2023 ESRD PPS final rule (87 FR 67147), we select the most appropriate wage and price proxies currently available to represent the rate of price change for each expenditure category. In contrast, the purpose of the inflation factors used in our outlier modeling is to represent the expected rate of change in price and utilization, so that we can prospectively set accurate FDL and MAP amounts that will result in outlier payments that equal 1.0 percent of total ESRD PPS payments. Decreasing our estimates of future outlier spending, as we are proposing to do, would result in lower FDL and MAP amounts, thereby increasing the number of claims that could be eligible for the outlier payment adjustment and the amount of outlier payments that would be paid on each claim. Revising our assumptions about future spending for ESRD outlier drugs and biological products would improve the ability of the ESRD outlier adjustment to pay for the costliest ESRD PPS claims. Therefore, we are proposing to use the projected inflation factor for ESRD outlier services that are drugs and biological products derived from the historical trend in prices and utilization for ESRD outlier drugs, as described in the previous paragraph. In section II.B.3.e of this proposed rule, we present the proposed CY 2025 MAP and FDL amounts calculated using this proposed methodology.
As previously discussed, CMS uses different methodologies for the inflation factors for laboratory tests and supplies. We inflate laboratory test prices to the upcoming CY using a CPI forecast to estimate changes for years in which a new data reporting period will take place for the purpose of setting CLFS rates; however, the forecast estimate used since CY 2018 for the ESRD PPS outlier methodology has been 0, because there has been no updated reporting for most clinical diagnostic laboratory tests since the CY 2018 CLFS. For supplies, we apply a 0 percent inflation factor, because these prices are based on predetermined fees or prices established by the Medicare contractor. In the CY 2011 ESRD PPS proposed rule, we explained that we chose to use these factors so that the MAP would be based on pricing mechanisms currently in place for these services (74 FR49991).
The ESRDB market basket uses price proxies for goods and services included in furnishing renal dialysis services to determine the ESRDB market basket update. For example, the market basket price proxy for laboratory services is the PPI Industry for Medical and Diagnostic Laboratories (BLS series code #PCU621511621511) representing the change in the price of laboratory services conducted by medical and diagnostic laboratories reported on the ESRD facility cost reports. Similarly, the market basket price proxy for supplies is the PPI Commodity for Surgical and Medical Instruments (BLS series code #WPU1562) representing the change in the price of medical supplies reported on the ESRD facility cost reports.
We have considered whether these longstanding assumptions about price changes for laboratory tests and supplies would be appropriate for modeling changes in spending for outlier-eligible laboratory tests and supplies. Unlike with drugs and biological products, we do not have detailed historical pricing data for ESRD outlier laboratory tests and supplies to permit us to perform a similar analysis for these services as we did for drugs and biological products. However, we can compare the historical inflation factors we have used to the growth in the market basket price proxies for these categories of renal dialysis services. For supplies, we would typically assume a 0 percent update; however, the average 10-year historical growth in the PPI Commodity for Surgical and Medical Instruments is 0.9 percent. Likewise, in years when there is a CLFS data reporting period, we would typically use an inflation factor for laboratory tests based on a CPI projection, reduced by the productivity adjustment, through June of the year prior to the update year; however, the average 10-year historical annual growth for the PPI Industry for Medical and Diagnostic Laboratories is −0.4 percent.
Beginning for CY 2025, we are proposing to use the ESRDB market basket price proxies for laboratory tests and supplies for the purpose of calculating the growth in estimated spending for these outlier services in the upcoming CY. These would replace the current inflation factors which are used for laboratory tests and supplies. Compared to the current inflation
For CY 2025, we are proposing to update the MAP amounts for adult and pediatric patients using the latest available CY 2023 claims data. We are proposing to update the ESRD outlier services FDL amount for pediatric patients using the latest available CY 2023 claims data, and to update the ESRD outlier services FDL amount for adult patients using the latest available claims data from CY 2021, CY 2022, and CY 2023, in accordance with the methodology finalized in the CY 2023 ESRD PPS final rule (87 FR 67170 through 67174). The latest available CY 2023 claims data showed outlier payments represented approximately 1.0 percent of total Medicare payments.
The impact of this proposed update is shown in table 7, which compares the outlier services MAP amounts and FDL amounts used for the outlier policy in CY 2024 with the updated proposed estimates for this proposed rule for CY 2025. The estimates for the proposed CY 2025 MAP amounts, which are included in column II of table 7, were inflation adjusted to reflect projected 2025 prices for ESRD outlier services, in accordance with the proposed changes to the inflation factors discussed in section II.B.3.d of this proposed rule.
As demonstrated in table 7, the estimated FDL per treatment that determines the CY 2025 outlier threshold amount for adults (column II; $49.46) is lower than that used for the CY 2024 outlier policy (column I; $71.76). The lower threshold is accompanied by a decrease in the adjusted average MAP for outlier services from $36.28 to $33.57. For pediatric patients, there is an increase in the FDL amount from $11.32 to $223.44. There is a corresponding increase in the adjusted average MAP for outlier services among pediatric patients, from $23.36 to $58.39. We note that this substantial increase in the outlier threshold for pediatric patients reflects the proposed inclusion of certain composite rate drugs for outlier consideration, notably Healthcare Common Procedure Coding System (HCPCS) code J2997 (Injection, alteplase recombinant, 1 mg). As a result, a smaller proportion of pediatric patients would receive outlier payments, but the average outlier payment amounts would be significantly higher.
We estimate that the percentage of patient months qualifying for outlier
In the CY 2011 ESRD PPS final rule (75 FR 49081) and under § 413.220(b)(4), we reduced the per treatment base rate by 1.0 percent to account for the proportion of the estimated total payments under the ESRD PPS that are outlier payments as described in § 413.237. In the 2023 ESRD PPS final rule, we finalized a change to the outlier methodology to better achieve this 1.0 percent target (87 FR 67170 through 67174). Based on the CY 2023 claims, outlier payments represented approximately 1.0 percent of total payments, which has been our policy goal since the establishment of the ESRD PPS outlier adjustment. We believe the proposed methodological changes to the outlier calculation and the proposed change to the definition of ESRD outlier services would continue to effectively set the outlier MAP and FDL amounts for CY 2025 and future years, enabling the ESRD PPS to continue targeting outlier payments at 1.0 percent of total payments. We also note that the proposed recalibration of the FDL amounts would result in no change in payments to ESRD facilities for beneficiaries with renal dialysis items and services that are not eligible for outlier payments.
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), CMS established the methodology for calculating the ESRD PPS per-treatment base rate, that is, the ESRD PPS base rate, and calculating the per-treatment payment amount, which are codified at §§ 413.220 and 413.230. The CY 2011 ESRD PPS final rule also provides a detailed discussion of the methodology used to calculate the ESRD PPS base rate and the computation of factors used to adjust the ESRD PPS base rate for projected outlier payments and budget neutrality in accordance with sections 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) of the Act, respectively. Specifically, the ESRD PPS base rate was developed from CY 2007 claims (that is, the lowest per patient utilization year as required by section 1881(b)(14)(A)(ii) of the Act), updated to CY 2011, and represented the average per treatment MAP for composite rate and separately billable services. In accordance with section 1881(b)(14)(D) of the Act and our regulation at § 413.230, the per-treatment payment amount is the sum of the ESRD PPS base rate, adjusted for the patient specific case-mix adjustments, applicable facility adjustments, geographic differences in area wage levels using an area wage index, and any applicable outlier payment, training adjustment add-on, the TDAPA, the TPNIES, the post-TDAPA add-on payment adjustment, and the TPEAPA for CYs 2024, 2025 and 2026.
We are proposing an ESRD PPS base rate for CY 2025 of $273.20. This would be a 0.8 percent increase from the CY 2024 ESRD PPS base rate of $271.02. This proposed update reflects several factors, described in more detail as follows:
In the CY 2021 ESRD PPS final rule (85 FR 71427), we expanded eligibility for the TPNIES under § 413.236 to include certain capital-related assets that are home dialysis machines when used in the home for a single patient. To establish the TPNIES basis of payment for these items, we finalized the additional steps that the Medicare Administrative Contractors (MACs) must follow to calculate a pre-adjusted per treatment amount, using the prices they establish under § 413.236(e) for a capital-related asset that is a home dialysis machine, as well as the methodology that CMS uses to calculate the average per treatment offset amount for home dialysis machines that is used in the MACs' calculation, to account for the cost of the home dialysis machine that is already in the ESRD PPS base rate. For purposes of this proposed rule, we refer to this as the “TPNIES offset amount.”
The methodology for calculating the TPNIES offset amount is set forth in § 413.236(f)(3). Section 413.236(f)(3)(v) states that effective January 1, 2022, CMS annually updates the amount determined in § 413.236(f)(3)(iv) by the ESRD bundled market basket percentage increase factor minus the productivity adjustment factor. The TPNIES for capital-related assets that are home dialysis machines is based on 65 percent of the MAC-determined pre-adjusted per treatment amount, reduced by the TPNIES offset amount, and is paid for 2 CYs.
There are currently no capital-related assets that are home dialysis machines set to receive TPNIES for CY 2025, as the TPNIES payment period for the Tablo® System ended on December 31, 2023, and there are no TPNIES applications for CY 2025. However, as required by § 413.236(f)(3)(v), we propose to update the TPNIES offset amount annually according to the methodology described previously.
We propose a CY 2025 TPNIES offset amount for capital-related assets that are home dialysis machines of $10.18, based on the proposed CY 2025 ESRDB productivity-adjusted market basket update of 1.8 percent (proposed 2.3 percent market basket percentage increase reduced by the proposed 0.5 percentage point productivity adjustment). Applying the proposed update factor of 1.018 to the CY 2024 offset amount resulted in the proposed CY 2025 offset amount of $10.18 ($10.00× 1.018 = $10.18). We propose to update this calculation to use the most recent data available in the CY 2025 ESRD PPS final rule.
In the CY 2024 ESRD PPS final rule we finalized an add-on payment adjustment for certain new renal dialysis drugs and biological products, which would be applied for 3 years after the end of the TDAPA period (88 FR 76388 through 76397). This adjustment, known as the post-TDAPA add-on payment adjustment, is adjusted by the patient-level case-mix adjuster and is applied to every ESRD PPS claim. In that final rule we also clarified that for each year of the post-TDAPA period we would update the post-TDAPA add-on payment adjustment amounts based on utilization and ASP of the drug or biological product. For CY 2024 there is one drug, Korsuva® (difelikefalin), included in the calculation of the post-TDAPA add-on payment adjustment. In the CY 2024 ESRD PPS final rule (88 FR 76397), we finalized that the post-TDAPA add-on payment adjustment amount for Korsuva® would be $0.2493 and would begin on April 1, 2024.
For CY 2025, we will have two drugs included in the calculation of the post-TDAPA add-on payment adjustment. The post-TDAPA add-on payment adjustment period for one of these drugs, Korsuva®, began on April 1, 2024, so, conditional upon the continued receipt of the latest full calendar quarter of ASP data as described in § 413.234(c)(3), Korsuva® will be included in the calculation for the post-TDAPA add-on payment adjustment for the entirety of CY 2025. The other drug, Jesduvroq (daprodustat), began its 2-year TDAPA period on October 1, 2023, so its post-TDAPA add-on payment adjustment period will begin on October 1, 2025, conditional upon the continued receipt of the latest full calendar quarter of ASP data.
Based on the most recent utilization data, and following the calculation explained in the CY 2024 ESRD PPS final rule (88 FR 76388 through 76389) and § 413.234(g), the proposed post-TDAPA add-on payment adjustment amount for Korsuva® is $0.4047 for all 4 quarters of CY 2025. Under that same methodology, the proposed post-TDAPA add-on payment adjustment amount for Jesduvroq is $0.0019 for only the last quarter of CY 2025. We note that utilization data available at the time of this proposed rulemaking for Jesduvroq included only data from October 2023 through February 2024. As discussed in the CY 2024 ESRD PPS final rule (88 FR 76388 through 76389), we intend to update these calculations with the most recent available data in the final rule. Table 8 shows the proposed post-TDAPA add-on payment adjustment amounts for each quarter of CY 2025.
As discussed in the CY 2024 ESRD PPS final rule (88 FR 76393) and codified at 42 CFR 413.234(g), we have finalized a post-TDAPA add-on payment adjustment, which is based on the most recent year of utilization data and is calculated annually in each rulemaking cycle. Under § 413.234(g)(1), CMS bases the post-TDAPA add-on payment adjustment calculation on the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of ASP data. However, when a drug or biological product begins its TDAPA period in the fourth quarter of a CY, and, therefore, would be included in the post-TDAPA add-on payment adjustment calculation beginning in the fourth quarter 2 CYs later, there would likely not be a full year's worth of utilization data available at the time of proposed or final rulemaking for that CY due to the time-lag associated with collecting and processing utilization data for the final rule. For example, at the time of rulemaking for last year's ESRD PPS final rule, we had data available through June 2023 when calculating the post-TDAPA add-on payment adjustment amount for Korsuva® (88 FR 73697). However, for a drug or biological product that began its TDAPA payment period in October of the prior year, data from October through June would only represent 9 months of data. We believe it is important to have a full year's utilization data when determining the post-TDAPA add-on payment adjustment amount so that the post-TDAPA add-on payment adjustment appropriately captures the utilization of the drug or biological product as required by § 413.234(g)(1).
We are proposing that when there is insufficient data at the time of rulemaking, we would publish the post-TDAPA add-on payment adjustment amount via Change Request (CR) once we have a full 12 months of data. Specifically, we would publish the post-TDAPA add-on payment adjustment amount in a CR under the following circumstances: (1) a drug or biological product is ending its TDAPA period during the CY, and therefore under § 413.234(c)(1) will begin being included in the post-TDAPA add-on payment adjustment amount calculation during that CY; and (2) that drug or biological product does not have at least 12 full months of utilization data at the time the final rule is developed. We would still include an estimated post-TDAPA add-on payment adjustment amount in the proposed rule and update that estimated amount in the final rule, but we would note that the estimated amount presented in the final rule is subject to change. We note that the final post-TDAPA add-on payment adjustment amount published after the final rule could be higher or lower than the estimated amount presented in the final rule. We do not anticipate having less than a full year's utilization data at the time of rulemaking for drugs and biological products that begin receiving TDAPA payments in quarters other than the fourth quarter of the year; however, should such an instance arise, we would similarly publish the post-TDAPA add-on payment adjustment amount in a CR once 12 months of utilization data is available. We would indicate the quarterly release CR in which we intend to publish the final post-TDAPA add-on payment adjustment amount.
For CY 2025, there is one TDAPA drug, Jesduvroq, which is ending its TDAPA period in CY 2025 and for which we do not anticipate having a full 12 months' worth of utilization data at the time of final rulemaking. As such, we would indicate in the final rule that we intend to publish the post-TDAPA add-on payment adjustment amount for CY 2025 for Jesduvroq once we have a full year of utilization data. We generally intend to publish this updated post-TDAPA add-on payment adjustment amount two calendar quarters prior to the end of the TDAPA period, as this would allow for sufficient time to gather and analyze a year's worth of utilization data. For this drug, and for any drug or biological product that begins its TDAPA period in the fourth quarter of a CY, we would generally publish the post-TDAPA add-on payment adjustment amount at the beginning of the second quarter of the last CY of that drug or biological product's TDAPA period (that is, two calendar quarters before the drug is included in the post-TDAPA add-on payment adjustment amount). However, should circumstances arise that prevent us from calculating a post-TDAPA add-on payment adjustment amount at that time, we would publish the final post-TDAPA add-on payment adjustment amount at a later time.
This approach to publishing the post-TDAPA add-on payment adjustment amount calculation would not impact any drug or biological product that has at least one full year's worth of utilization data at the time when the analysis for the final rule is developed, nor would it impact any drug or biological product that is already
Section 1881(b)(14)(A)(i) of the Act requires the Secretary to implement a payment system under which a single payment is made to a provider of services or a renal dialysis facility for renal dialysis services in lieu of any other payment. Section 1881(b)(14)(B) of the Act defines renal dialysis services, and subclause (iii) of that section states that these services include other drugs and biologicals
When we implemented the ESRD PPS in 2011 (75 FR 49030), we interpreted this provision as including not only injectable drugs and biological products used for the treatment of ESRD (other than ESAs and any oral form of ESAs, which are included under clause (ii) of section 1881(b)(14)(B) of the Act), but also all oral drugs and biological products used for the treatment of ESRD and furnished under title XVIII of the Act. We also concluded that, to the extent oral-only drugs or biological products used for the treatment of ESRD do not fall within clause (iii) of section 1881(b)(14)(B) of the Act, such drugs or biological products would fall under clause (iv) of that section, and constitute other items and services used for the treatment of ESRD that are not described in clause (i) of section 1881(b)(14)(B) of the Act.
We finalized and promulgated payment policies for oral-only renal dialysis service drugs or biological products in the CY 2011 ESRD PPS final rule (75 FR 49038 through 49053). In that rule, we defined renal dialysis services at § 413.171 as including drugs and biological products with only an oral form. We also finalized a policy to delay payment for oral-only drugs under the ESRD PPS until January 1, 2014. Accordingly, we codified the delay in payment for oral-only renal dialysis service drugs and biological products at § 413.174(f)(6), and provided that payment to an ESRD facility for renal dialysis service drugs and biological products with only an oral form would be incorporated into the ESRD PPS payment rates effective January 1, 2014, once we had collected and analyzed adequate pricing and utilization data. Since oral-only drugs are generally not a covered service under Medicare Part B, this delay of payment under the ESRD PPS also allowed coverage to continue under Medicare Part D for those beneficiaries with such coverage.
In the CY 2011 ESRD PPS proposed rule (74 FR 49929), we noted that the only oral-only drugs that we identified were phosphate binders and calcimimetics, specifically, cinacalcet hydrochloride, lanthanum carbonate, calcium acetate, sevelamer hydrochloride, and sevelamer carbonate. All of these drugs fall into the ESRD PPS functional category for bone and mineral metabolism.
Since then, the Congress has acted three times to further delay the inclusion of oral-only renal dialysis service drugs and biological products in the ESRD PPS. Specifically, as discussed in section II.A.1 of this proposed rule, ATRA in 2013, as amended by PAMA in 2014, and amended by ABLE in 2014, ultimately delayed the inclusion of oral-only drugs into the ESRD PPS until January 1, 2025.
Section 217(c)(1) of PAMA also required us to adopt a process for determining when oral-only drugs are no longer oral-only and to incorporate them into the ESRD PPS bundled payment. Section 217(a)(2) of PAMA further amended section 632(b)(1) of ATRA by requiring that, in establishing payment for oral-only drugs under the ESRD PPS, the Secretary must use data from the most recent year available. In the CY 2016 ESRD PPS proposed rule (80 FR 37839), we noted that when the existing oral-only drugs (which were, at that time, only phosphate binders and calcimimetics) were determined no longer to be oral-only drugs, we would pay for them using the TDAPA. We stated that this would allow us to collect data reflecting current utilization of both the oral and injectable or intravenous forms of the drugs, as well as payment patterns and beneficiary co-pays, before we add these drugs to the ESRD PPS bundled payment.
In 2017, when an injectable calcimimetic became available, CMS issued a Change Request
Most recently, in the CY 2023 ESRD PPS final rule (87 FR 67185 through 67186), we finalized a revision to the regulatory definition of an oral-only drug, effective January 1, 2025, to clarify our longstanding policy by specifying that an oral-only drug has no injectable functional equivalent. The effective date of this revised definition will coincide with the January 1, 2025, incorporation of oral-only drugs into the ESRD PPS under § 413.174(f)(6). The revised definition of oral-only drugs reflects that drugs with similar end-action effects are treated as equivalent under the ESRD PPS, consistent with our approach to designating drugs into ESRD PPS functional categories.
Existing regulations at § 413.174(f)(6) state that effective January 1, 2025, oral-only drugs will be paid for under the ESRD PPS. Although oral-only drugs are excluded from the ESRD PPS bundled payment until January 1, 2025, they are currently recognized as renal dialysis services as defined in regulation at § 413.171. Accordingly, CMS is planning to incorporate oral-only drugs into the ESRD PPS bundled payment beginning January 1, 2025, using the TDAPA, as described in the CY 2016 ESRD PPS final rule (80 FR 69027) and subsequent rules.
As we stated in the CY 2023 ESRD PPS final rule (87 FR 67180), if an injectable equivalent or other form of administration of phosphate binders were to be approved by FDA prior to January 1, 2025, the phosphate binders would no longer be considered oral-only drugs and would no longer be paid for outside the ESRD PPS. We stated that
We note that on October 17, 2023, a new oral phosphate lowering agent received FDA marketing approval. According to the FDA label information for this drug, XPHOZAH
As set forth in § 413.174(f)(6), effective January 1, 2025, payment to an ESRD facility for renal dialysis service drugs and biological products with only an oral form furnished to ESRD patients will be incorporated within the prospective payment system rates established by CMS in § 413.230 and separate payment will no longer be provided. As noted earlier in this section, we have recently published operational guidance, including information about TDAPA payment, HCPCS codes, and ASP reporting requirements and timelines for phosphate binders at
We note that for any other oral-only drugs, such as XPHOZAH
In the CY 2011 ESRD PPS final rule (75 FR 49043), we explained that there were certain advantages to delaying the implementation of payment for oral-only drugs and biological products under the ESRD PPS. These advantages included allowing ESRD facilities additional time to make operational changes and logistical arrangements to furnish oral-only renal dialysis service drugs and biological products to their patients.
In November 2023, in accordance with section 632(d) of ATRA, the Government Accountability Office (GAO) published a Report to Congressional Committees titled, “End-Stage Renal Disease: CMS Plans for including Phosphate Binders in the Bundled Payment.” (GAO-24-106288).
With respect to considerations related to staffing, we note that the ESRD PPS includes payment for staffing related to the provision of renal dialysis services. We believe there are several strategies that ESRD facilities could employ to efficiently use available staff time to provide phosphate binders. There are parallels between the administration of phosphate binders and the administration of oral calcimimetics, which are also typically taken daily. First, we expect that patients with ESRD generally receive treatment for at least 3 hours per session, typically three times per week. We believe that during this treatment window there is generally staff availability to provide the patient with pre-packaged medication, which we note could include medication for multiple days. Second, ESRD facilities could maximize the efficiency of staff time by mailing the prescriptions, to the extent that doing so is consistent with state pharmacy laws. For example, the GAO report identified that one large dialysis organization only mails oral prescriptions to patients' homes, while others mail the medication to either the ESRD facility or the patient's home. Third, the GAO report identified that some ESRD facilities contract with outside pharmacies rather than operating their own pharmacy. By contracting with outside pharmacies, ESRD facilities could reduce or avoid the need to hire additional pharmacists and pharmacy staff to manage the volume of prescriptions.
Another challenge identified by the dialysis organizations was the complexity of dispensing phosphate binders because of the broad array of phosphate binders and the high volume of pills.
We recognize that updates may be required to ESRD facilities' systems, including electronic medical records, billing systems, and inventory management systems to accommodate new procedures for dispensing phosphate binders. As we previously noted, we initially delayed the incorporation of oral-only drugs into the ESRD PPS in 2011, in part to allow ESRD facilities to make such operational changes and logistical arrangements. In addition, we have provided operational guidance at
Dialysis organizations have expressed concerns surrounding CMS using ASP to determine the TDAPA amount added to the ESRD PPS base rate for phosphate binders, which they believe does not adequately provide for dispensing cost.
As noted earlier, we have issued guidance
We anticipate that the incorporation of oral-only drugs into the ESRD PPS will increase access to these drugs for beneficiaries. We estimate that there will be an increase in Medicare spending as a result of this increase in access. Specifically, CMS has been monitoring and analyzing data regarding beneficiary access to Medicare Part D drugs; increases in expenditures for renal dialysis drugs paid under Medicare Part D; health equity implications of varying access to Medicare Part D drugs among patients with ESRD; and ESRD facility behavior regarding drug utilization. We have seen that incorporating Medicare Part D drugs into the ESRD PPS has had a significant positive effect of expanding access to such drugs for beneficiaries who do not have Medicare Part D coverage, with significant positive health equity impacts. For example, based on the results of our ESRD PPS monitoring analyses, in December 2017, prior to incorporation of calcimimetics into the ESRD PPS bundle, utilization was at 28.97 percent for African American/Black beneficiaries but went up to 35.31 percent in January 2018 and eventually to 39.04 percent in at the end of the TDAPA period for calcimimetics in December 2021. This 10.07 percentage point increase in utilization reflects the significant access improvement for African American/Black beneficiaries of incorporating formerly oral-only drugs into the ESRD PPS.
Lastly, as part of the preparation for the inclusion of phosphate binders into the ESRD PPS, CMS has monitored Part D utilization of, and spending for, phosphate binders. We have developed budgetary estimates of the changes in Medicare Part B and Part D spending, which are discussed in section VIII.C.1 of this proposed rule.
Section 1881(b)(14)(D)(iii) of the Act provides that the ESRD PPS shall include a payment adjustment that reflects the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services, and for payment for renal dialysis services furnished on or after January 1, 2011, and before January 1, 2014, such payment adjustment shall not be less than 10 percent. Therefore, the ESRD PPS provides a facility-level payment adjustment to ESRD facilities that meet the definition of a low-volume facility.
Under § 413.232(b), a low-volume facility is an ESRD facility that, based on the submitted documentation: (1) furnished less than 4,000 treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month costs reports, whichever is most recent, except as specified in paragraphs (g)(4) and (5)) preceding the payment year; and (2) has not opened, closed, or received a new provider number due to a change in ownership (except where the change in ownership results in a change in facility type or as specified in paragraph (g)(6)) in the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent) preceding the payment year.
In addition, under § 413.232(c), for purposes of determining eligibility for the LVPA, the number of treatments considered furnished by the ESRD facility equals the aggregate number of treatments furnished by the ESRD
In the CY 2011 ESRD PPS final rule (75 FR 49118 through 49125), we finalized the methodology used to target the appropriate population of ESRD facilities that were low-volume facilities based on a treatment threshold. After consideration of public comments, we originally established an 18.9 percent adjustment for ESRD facilities that furnish less than 4,000 treatments annually and indicated that this increase to the base rate would encourage small ESRD facilities to continue providing access to care.
In the CY 2016 ESRD PPS proposed rule (80 FR 37819), we analyzed ESRD facilities that met the definition of a low-volume facility under § 413.232(b) as part of the updated regression analysis and found that these ESRD facilities still had higher costs compared to other ESRD facilities. A regression analysis of low-volume facility claims from CYs 2012 and 2013 and cost report data indicated a multiplier of 1.239; therefore, we proposed an updated LVPA adjustment factor of 23.9 percent in the CY 2016 ESRD PPS proposed rule (80 FR 37819) and finalized this policy in the CY 2016 ESRD PPS final rule (80 FR 69001). This update was implemented budget neutrally alongside numerous other changes to the case-mix and facility-level adjusters. In CY 2022, 352 ESRD facilities received the LVPA. Using the most recent available data for CY 2023, the number of ESRD facilities receiving the LVPA was 330.
In the CY 2021 ESRD PPS final rule (85 FR 71443), we finalized a policy to allow ESRD facilities flexibility for LVPA eligibility due to the COVID-19 Public Health Emergency (PHE). Under § 413.232(g)(4), for purposes of determining ESRD facilities' eligibility for payment years 2021, 2022, and 2023, we only considered total dialysis treatments for any 6 months of their cost-reporting period ending in 2020. In the CY 2024 ESRD PPS final rule (88 FR 76344), we finalized changes to the LVPA regulation at § 413.232 that allow ESRD facilities affected by disasters and other emergencies to qualify for exceptions to certain eligibility requirements for the LVPA. Facilities may close and reopen if they experience an emergency, or they may temporarily exceed the 4,000-treatment threshold if they take on additional patients displaced by an emergency and still qualify for the LVPA.
Interested parties, including MedPAC and the GAO,
We considered several changes to the LVPA eligibility criteria to address the concerns that interested parties, including the GAO and MedPAC, raised about targeting LVPA payments to ESRD facilities that are necessary to protect access to care and are not located near other ESRD facilities. Specifically, these interested parties have requested that we take into consideration the geographic isolation of an ESRD facility within the LVPA methodology. Section 1881(b)(14)(D)(iii) of the Act requires that the LVPA must reflect the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services. Our analysis has found that isolated low-volume facilities do not face higher costs than other low-volume facilities. Therefore, we do not believe that this requested change reconciles with the central statutory requirements and limitations for the LVPA, and we are considering alternative approaches, including potentially addressing this issue through a new payment adjustment separate from the LVPA based on section 1881(b)(14)(D)(iv) of the Act. Currently, we are analyzing claims and cost data regarding dialysis treatment levels and cost to inform options for potentially tailoring our methodology to meet the requirements of the statute, while simultaneously collecting additional data on geographic isolation of ESRD facilities. The ESRD PPS has separate facility-level payment adjustments for low-volume facilities, as set forth in 42 CFR 413.232, and facilities in rural areas, as set forth in § 413.233. To avoid overlap with these existing facility-level adjustments, we are analyzing the impact of potentially creating a new payment adjustment and considering innovative methodological options, such as the local dialysis need methodology on which we requested information in the CY 2024 ESRD PPS proposed rule (88 FR 42441 through 42445).
In addition, we have heard from interested parties that the eligibility criteria for the LVPA are very explicit and leave little room for flexibility in certain circumstances (85 FR 71442). Some also view the attestation process as burdensome to ESRD facilities and believe it may discourage participation by small ESRD facilities with limited resources that would otherwise qualify for the LVPA.
CMS's contractor has held three Technical Expert Panels (TEPs) to discuss potential refinements to the ESRD PPS.
In the CY 2022 ESRD PPS proposed rule LVPA RFI, we sought input on alternative approaches to the LVPA methodology (86 FR 36398 through 36399).
In the CY 2024 ESRD PPS proposed rule (88 FR 42430 through 42544), we issued a RFI regarding several possible modifications to the current LVPA methodology.
We have considered several changes to the LVPA eligibility criteria to address the concerns that the GAO and MedPAC raised about targeting LVPA payments to ESRD facilities that are necessary to protect access to care and are not located near other ESRD facilities. As previously discussed, we do not believe the suggestion to consider facilities' geographic isolation reconciles with the central statutory requirements and limitations for the LVPA, and we are considering alternative approaches, including potentially addressing this issue through a new payment adjustment separate from the LVPA based on section 1881(b)(14)(D)(iv) of the Act.
The LVPA and rural adjusters currently result in increased payments to some geographically isolated ESRD facilities, but these adjusters do not specifically target geographically isolated ESRD facilities. Interested parties, including MedPAC and the GAO, have recommended that CMS make refinements to the LVPA and rural adjusters to better target ESRD facilities that are critical to beneficiary access to dialysis care in remote or isolated areas. The GAO and MedPAC, among others, have also raised concerns about targeting LVPA payments to ESRD facilities that are not located near other ESRD facilities to protect access to care.
In the CY 2024 ESRD PPS proposed rule's LVPA RFI (88 FR 42441 through 42445), we solicited comments on a potential new payment adjustment that accounts for isolation, rurality, and other geographical factors, including local dialysis need (LDN). The LDN methodology, as described in the CY 2024 ESRD PPS proposed rule (88 FR 42430 through 42544), would consider LDN instead of basing payment strictly upon a rural designation, as provided for by §§ 413.233 and 413.231(b)(2). In the CY 2024 ESRD PPS proposed rule's LVPA RFI, we suggested the utilization of census tracts to identify geographic areas with low demand, then calculating latent demand by multiplying the number of beneficiaries near (“near” was defined by driving time to ESRD facilities) an ESRD facility by the average number of treatments for ESRD beneficiaries. The threshold to qualify for the LVPA could then be applied by determining the amount of adjusted latent demand. The ESRD facilities that fall below the threshold would be eligible. The statutory requirements for the LVPA under section 1881(b)(14)(D)(iii) of the Act generally would not allow for CMS to account for geographic isolation outside of the extent to which low-volume facilities face higher costs in furnishing renal dialysis services than other facilities, and preliminary analysis found that, in general, low-volume facilities that are rural, isolated, or located in low-demand areas did not have higher costs than low-volume ESRD facilities overall. Because of this, the LDN methodology
We received 23 comments in response to the LVPA RFI, all of which had differing opinions.
Generally, commenters were opposed to a payment adjustment based on the LDN methodology, reiterating many of the concerns raised during the 2020 TEP. A coalition of dialysis organizations voiced the concern that the LDN methodology would take away providers' ability to make financial decisions about their operations, since they would not be able to predict their eligibility for the LDN payment adjustment nor the amount they would receive. They maintained that the LDN may not target the appropriate facilities and could provide opportunities for gaming. The coalition also claimed that the central issue faced by these facilities is low patient count, which they stated that the LDN methodology would not recognize, and thus the adjustment could be provided to facilities that are isolated, but have high patient counts, and are not in need of an additional payment adjustment. A coalition of dialysis organizations and a non-profit dialysis association both stated that the current LVPA provision to aggregate the treatments of facilities under common ownership that are not at least 5 miles apart is an important feature that discourages gaming, one that is not included in the LDN methodology. Furthermore, the coalition noted that the LDN methodology would lack stability, given that patient location varies over time. MedPAC suggested that if the LDN were adopted, CMS should ensure that the methodology is transparent; for example, making the specifications and results for the regression equation available on CMS's website and in the
In addition to the questions outlined in the CY 2024 ESRD PPS proposed rule LVPA RFI, CMS has also considered incorporating isolation criteria into the rural facility adjustment, where payment of the adjustment could be limited to ESRD facilities that are isolated from other ESRD facilities, or a higher adjustment could be applied for isolated rural facilities than for non-isolated rural facilities. Alternatively, the current rural facility adjustment could be replaced by an adjustment based solely on isolation. We note that recent analysis has confirmed that, in general, low-volume facilities that are rural, isolated, or located in low-demand areas did not have higher costs than low-volume ESRD facilities overall. This analysis aligns with suggestions from various commenters, including MedPAC, to refine or remove the rural facility adjustment to better target ESRD facilities that are critical to beneficiary access and are likely not being adequately targeted under the current methodology. However, we note that many ESRD facilities which receive the rural facility adjustment are critical to patient access and that these ESRD facilities may be relying on the additional payment from the rural facility adjustment for the coming years. As discussed in section II.B.2.f.(2) of this proposed rule, we are proposing to implement a phase-out policy for ESRD facilities that lose the rural facility adjustment as a result of being redesignated from a rural area to an urban area in the most recent CBSA delineations. We are not proposing any other changes to the rural facility adjustment in this proposed rule.
The goals of the ESRD PPS (including the LVPA) are to align resource use with payment, advance health equity and protect access to renal dialysis services for vulnerable beneficiaries in underserved communities, including rural and isolated communities, by increasing payments to certain ESRD facilities in these areas to align with their higher costs. As noted in the CY 2016 ESRD PPS final rule (80 FR 68967 through 69077), we aim to target the benefit of the LVPA to facilities that serve the access needs of patients in remote locations. In the CY 2022 ESRD PPS final rule (86 FR 61874 through 62026), we detailed our commitment to achieving equity in health care outcomes for our beneficiaries using the definition of equity set forth in Executive Order 13985,
In this proposed rule, we are proposing to refine the LVPA methodology to include two tiers based on treatment volume with different payment adjustments for each tier. This proposed methodology would be similar to the methodology described in the CY 2024 ESRD PPS proposed rule RFI (88 FR 42430 through 42544), but with methodological changes to improve consistency in an ESRD facility's tier assignment from year to year.
We analyzed cost report data from ESRD facilities to develop the tiered thresholds and adjustment amounts for the proposed LVPA. This analysis used a logarithmic regression model that controls for various geographical and
Table 9 presents our proposed two-tiered LVPA methodology, which is based on data from ESRD facility cost reports such that the reporting periods include some part of the period between January 1, 2020, to December 31, 2022 (that is, beginning or ending during these 3 CYs). We note that we have required budget neutrality for any change to the LVPA methodology, so any proposed changes to the LVPA cannot increase or decrease total estimated ESRD PPS payments; therefore, the two sets of potential adjustment factors in table 9 would be implemented budget-neutrally. The second column presents the unscaled adjusters, which if implemented, would cause the ESRD PPS base rate to be reduced by a factor of 0.999262, approximately $0.20, to achieve budget neutrality. The third column presents the adjusters scaled down by a factor of 0.815 to maintain the LVPA payment amount under the existing methodology of $26.7 million based on the expected CY 2025 LVPA payments. Using the scaled adjusters would maintain budget neutrality without lowering the ESRD PPS base rate.
The adjustment factors in the second column are derived from the regression explained previously. These results indicate that facilities which furnish less than 3,000 treatments have costs that are 34.9 percent higher than non-low-volume facilities, and facilities that furnish between 3,000 and 3,999 treatments have costs that are 22.2 percent higher. The adjustment factors in the third column, which are scaled down, reflect the same relationship between the two tiers of low-volume facilities and non-low-volume facilities.
We believe that a two-tier scaled approach is appropriate because it would increase payments to facilities with the lowest volume while keeping payment changes contained within the LVPA. In CY 2016 ESRD PPS final rule (80 FR 68972 through 69004) when we last updated the LVPA adjustment factor, we also updated most of the facility-level and case-mix adjusters. At that time, it was appropriate to apply a budget-neutrality factor that represented all of the changes to the facility-level and case-mix adjusters. However, we are only proposing changes to the LVPA at this time, and it is most appropriate to contain the changes within the current LVPA by applying a scaling factor to the LVPA adjusters.
We also analyzed a three-tiered option that would include a tier for ESRD facilities furnishing between 4,000 and 5,000 treatments, which is presented in table 10. As noted previously, we considered both scaled and unscaled adjustment factors, with both maintaining budget neutrality. Our analysis showed that the scaled, three-tiered option would reduce payments for facilities furnishing less than 3,000 treatments as compared to both the current LVPA methodology and the proposed two-tiered scaled methodology. Because payments for facilities furnishing between 4,000 and 5,000 treatments would increase, payments for the lowest-volume facilities would need to decrease to maintain budget neutrality, which we do not believe would align with the goals of the LVPA outlined previously. We believe that if we were to propose a three-tiered option, budget neutralizing the base rate rather than scaling the adjustment factors would better align with these goals. Our analysis shows that an unscaled three-tiered adjustment would result in a $0.99 reduction to the base rate. We are seeking comment on our proposed scaled, two-tier proposal and on the alternative three-tier LVPA structure. We note that, should this alternative be finalized, we would make changes to § 413.232(b)(1) to reflect the increased LVPA threshold of 5,000. As discussed further in the next subsection, we are proposing to determine an ESRD facility's LVPA tier based on the median treatment count volume of the last three cost-reporting years, rather than using a single year treatment count. Therefore, expanding LVPA eligibility to ESRD facilities that furnished fewer than 5,000 treatments in each of the past three cost-reporting years would also increase the number of ESRD facilities that would qualify for tier 1 and tier 2, since ESRD facilities which furnished between 4,000 and 4,999 treatments in one of the
We are proposing a two-tiered LVPA using the scaled adjusters presented in the second column of table 9. ESRD facilities that fall into the first tier (those that furnish fewer than 3,000 treatments) would receive a payment adjustment of 28.4 percent. Those that fall in the second tier (those that furnish 3,000 or more treatments but fewer than 4,000 treatments) would receive a payment adjustment of 18.1 percent. Outside of the change to the LVPA amount, this proposed change would not impact how the LVPA is applied to ESRD PPS payments.
One potential complication with a tiered approach to the LVPA is that there are still payment cliffs present between the tiers. This may discourage ESRD facilities from increasing their treatment volume in a given year, especially if it is uncertain whether the ESRD facility's treatment volume in future years will stay at the increased level. To address this, we are proposing to determine an ESRD facility's LVPA tier based on the median treatment count volume of the last three cost-reporting years, rather than using a single year treatment count. This proposed methodology would smooth payments over years, increasing stability and predictability in payments to low-volume facilities. We are also proposing that, should a facility receive an exception under § 413.232(g)(5) in one or more of the past three cost-reporting years, the median treatment count of the unaffected cost-reporting years would be used to make the facility's tier determination. We note that the median of two numbers is the average of those numbers, and the median of one number is that number. In the case that a facility does not have cost-reporting data from the last 3 years that are unaffected by a disaster or other emergency, we would assign the facility to a tier based on their last full year of unaffected treatment volume, assuming all LVPA eligibility criteria are met.
We believe that the proposed median treatment approach would promote stability, especially for facilities whose treatment counts are on the margins of a tier. We also believe that the proposed smoothing methodology for determining the treatment volume tier for which an ESRD facility qualifies is better than the alternative of using the highest tier (in terms of treatment volume) for which an ESRD facility has qualified in each of the past years. For example, if we used the highest tier of the last 3 years and a facility furnishes 3,500 treatments in one of the past 3 years, it would be categorized as tier 2 even if it furnished fewer than 3,000 treatments in the other 2 years. We believe that the proposed smoothing would mitigate the introduction of a cliff-effect within the tiers.
By contrast, under the proposed smoothing methodology, if the cost-reporting data indicated that the facility furnished 2,500, 2,999, and 3,500 treatments in the 3 years preceding the payment year, the median tier would be identified (tier 1 in this case), and the facility would (in the proposed two-tier system with scaling) receive a 28.4 percent payment adjustment for all of the treatments furnished during the payment year. We expect that any higher or lower payments from year to year under this policy would balance out over time without putting additional burden on the MACs. The structure of the proposed scaled, two-tier LVPA methodology is presented in table 10, and the structure of the alternative three-tier unscaled LVPA methodology is presented in table 11. For the purposes of comparison, we have included the scaled and unscaled version of both of the potential LVPA structures.
We note that we are not proposing any changes to the methodology for determining eligibility for the LVPA under § 413.232(b)(1), as the purpose of this proposed change is to better allocate payments within the LVPA, not to expand the LVPA to facilities that have furnished more than 4,000 treatments in one of the past three cost-reporting years. We would continue to determine eligibility for the LVPA based on a facility's treatment count in each of the three cost-reporting years preceding the payment year as set forth in § 413.232(b)(1) and would not consider the median treatment count over that period for purposes of determining eligibility. Likewise, we are not proposing any changes to § 413.232(g)(5), which allows for an exception to the requirement at § 413.232(b)(1) in the case of a disaster or other emergency. In the CY 2011 ESRD PPS final rule (75 FR 49030 through 49214), we stated that we believe a 3-year waiting period serves as a safeguard against facilities that have the opportunity to take a financial loss in establishing facilities that are purposefully small. In response to the CY 2024 ESRD PPS proposed rule RFI (88 FR 42430 through 42544), several interested parties commented that they believe CMS should maintain the 3-year attestation to determine eligibility for the LVPA, as it is an important
If finalized, the proposed median treatment count methodology for determining an eligible ESRD facility's LVPA tier would improve the stability and predictability of the LVPA by basing tier determination on the median treatment count of the last 3 years as opposed to the treatment count for each of the last 3 years, where facilities could be disqualified from a higher adjustment based on marginal changes. The proposed tiered smoothing methodology would also better align payment with resource use by minimizing the impact of the payment cliff between the LVPA tiers in a transparent and reproducible fashion. We are soliciting comments on each aspect of our proposal: (1) the tiered structure of the LVPA; (2) using the median treatment count volume to determine the LVPA payment tier for ESRD facilities that are eligible for the adjustment; and (3) the scaling of the adjusters to maintain LVPA payments at the same level. As previously discussed, we are also considering an alternative three-tiered structure, which would have the effect of reducing the base rate by $0.99. We are soliciting comments on whether this alternative methodology could be more appropriate than the proposed methodology. We recommend readers to provide as much detail as possible in their response to the comment solicitation.
As previously discussed, we recognize the importance of revising the ESRD PPS LVPA methodology to ensure that payments are accurately aligned with resource use, adequately target low-volume facilities, and strive for healthcare equity for ESRD beneficiaries. We are seeking information from the public about potential approaches to further refine the ESRD PPS methodology, which we would take into consideration for any potential future changes to the LVPA.
This section describes a RFI regarding the LVPA. Upon reviewing this RFI, respondents are encouraged to provide complete, but concise responses. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), application, proposal abstract, or quotation. This RFI does not commit the United States Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through this RFI and will not accept unsolicited proposals. Responders are advised that the United States Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Failing to respond to this RFI will not preclude participation in any future procurement, if conducted.
We note that we will not respond to questions about the policy issues raised in this RFI. We may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review RFI responses. Responses to this RFI are not offers and cannot be accepted by the United States Government to form a binding contract or issue a grant. Information obtained because of this RFI may be used by the United States Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. All submissions become United States Government property and will not be returned. We may publicly post the comments received, or a summary thereof.
As previously discussed, under § 413.232(b), a low-volume facility is an ESRD facility that, based on the submitted documentation: (1) furnished less than 4,000 treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month costs reports, whichever is most recent, except as specified in paragraphs (g)(4) and (5)) preceding the payment year; and (2) has not opened, closed, or received a new provider number due to a change in ownership (except where the change in ownership results in a change in facility type or as specified in paragraph (g)(6)) in the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent) preceding the payment year.
We are soliciting comment on potential changes to the LVPA eligibility for new ESRD facilities that could be included as part of either the proposed tiered structure or a different methodology in the future. As previously discussed, the current single-threshold LVPA methodology and the proposed tiered LVPA methodology (discussed in the previous section) rely upon 3 years of cost-reporting data to determine eligibility for the adjustment. We are considering whether it could be appropriate to modify this requirement to support access to renal dialysis in underserved areas by allowing LVPA payments for new ESRD facilities that have not yet accrued 3 years of cost-reporting data. We are also evaluating the most appropriate way for a new low-volume ESRD facility to demonstrate or attest that it expects to be low-volume. Alongside this potential change, we are considering whether it would be appropriate to implement a reconciliation process for ESRD facilities that fail to furnish a low enough treatment volume to qualify for the LVPA or their predicted tier. For example, should the proposal to implement a tiered LVPA be finalized, the determination of a facility's tier assignment for the first year would be based on their anticipated treatment count, for which they would receive the corresponding LVPA amount. Then, if the ESRD facility furnished a treatment volume count that would otherwise have qualified them for a different tier, we would also undergo a reconciliation process. For future years the ESRD facility would receive the LVPA amount of the tier following the same smoothing methodology (should it be finalized) based on the median of their treatment counts for the available years. After we receive the cost-reporting data for the year in question, the facility could be placed in the appropriate LVPA tier, and could either re-pay CMS for an overestimation, or receive additional payment from CMS for an underestimation, if applicable. The anticipated treatment count for the following year could then be based upon the actual treatment count of the prior year. This process would be followed until a new ESRD facility gathers 3 years of cost-reporting data, after which the median treatment count over those 3 years would determine the facility's tier assignment if the proposed LVPA methodology is finalized. We are issuing this RFI to seek feedback on the potential future changes to the LVPA, as described previously, and to solicit further input from interested parties to inform potential future modifications to the methodology used to determine the LVPA.
In particular, we seek input and responses to the following considerations, requests, and questions:
++ Whether the LVPA or another adjustment, such as the LDN methodology discussed earlier, would be the most appropriate payment pathway to support access to renal dialysis services in areas that do not
++ What would be the most appropriate way or ways for a new ESRD facility to demonstrate or attest that it expects to be low-volume?
++ The potential for future reconciliation process as an appropriate accommodation for new ESRD facilities.
++ Whether a reconciliation process would be an effective tool for making appropriate payments to existing ESRD facilities that have three or more years of cost reporting data.
++ Would a reconciliation process be operationally straightforward and understandable for an ESRD facility that has opened in the past 3 years?
++ Would a reconciliation process make it more difficult for ESRD facilities to plan and budget for future payment years? Is this outweighed by the potential benefit of earlier access to the LVPA for these new facilities?
++ Would it be useful or feasible to implement a reconciliation process for ESRD facilities that have not opened in the past 3 years but, for whatever reason, may have furnished a low enough treatment volume to qualify for the LVPA?
++ Could the LVPA be changed in any way to better support ESRD facilities opening in underserved areas? Are there any costs specific to low-volume facilities for which the current LVPA does not account?
++ How are the costs for providers of low-volume home dialysis different from the costs for providers of low-volume in-center dialysis? Could the LVPA be an appropriate pathway to support the provision of home dialysis through increased payment?
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), we established the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) under the ESRD PPS, under the authority of section 1881(b)(14)(D)(iv) of the Act, to support ESRD facility use and beneficiary access to these new technologies. For additional background of the TPNIES we refer readers to the CY 2024 ESRD PPS final rule (88 FR 76410 through 76412).
Our practice is to include the summary of each TPNIES application and our analysis of the eligibility criteria for each application in the annual ESRD PPS proposed rule. Because we did not receive any applications for the TPNIES for CY 2025, no TPNIES application summary or CMS analysis has been included in this proposed rule.
As part of the TPNIES eligibility requirements in § 413.236(b)(4), a covered equipment or supply must have a complete HCPCS Level II code application submitted, in accordance with the HCPCS Level II coding procedures on the CMS website, by the HCPCS Level II code application deadline for biannual Coding Cycle 2 for durable medical equipment, orthotics, prosthetics and supplies (DMEPOS) items and services as specified in the HCPCS Level II coding guidance on the CMS website prior to the particular CY. We have identified a minor error in § 413.236(b)(4). Specifically, we inadvertently transposed the words orthotics and prosthetics within the DMEPOS acronym. The acronym was intended to read durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) instead of durable medical equipment, orthotics, prosthetics and supplies (DMEPOS).
As described in the HCPCS Level II Coding Procedures, HCPCS Level II is a standardized coding system that is used primarily to identify drugs, biologicals and non-drug and non-biological items, supplies, and services not included in the CPT® code set jurisdiction, such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office.
While the HCPCS level II Coding Procedures include DMEPOS as an example of items for which HCPCS Level II codes are established, we believe that the phrase non-drug and non-biological items more broadly reflects all items, supplies, and services for which HCPCS Level II codes are established and aligns with the HCPCS Level II coding procedures on the CMS website. Therefore, we are proposing a technical change at § 413.236(b)(4) to remove the reference to the phrase durable medical equipment, orthotics, prosthetics and supplies (DMEPOS) and replace it with the phrase non-drug and non-biological items. We are also adding the word supplies. These technical changes would better reflect the broader category of non-drug and non-biological item coding in the HCPCS Level II Coding Procedures available on the CMS website.
In this section of the final rule, we identify any items previously approved for the TPNIES and for which payment is continuing for CY 2025. As described in the CY 2024 ESRD PPS final rule, no new items were approved for the TPNIES for CY 2024 (88 FR 76431). As such there are no items previously approved for the TPNIES for which payment is continuing in CY 2025.
Under § 413.234(c)(1), a new renal dialysis drug or biological product that is considered included in the ESRD PPS base rate is paid the TDAPA for 2 years. In July 2023, CMS approved Jesduvroq (daprodustat) for the TDAPA under the ESRD PPS, effective October 1, 2023. Implementation instructions are specified in CMS Transmittal 12157, dated July 27, 2023, and available at:
In April 2024, CMS approved DefenCath® (taurolidine and heparin sodium) for the TDAPA under the ESRD PPS, effective July 1, 2024. Implementation instructions are specified in CMS Transmittal 12628, dated May 9, 2024, and available at:
Table 11 identifies the two new renal dialysis drugs for which the TDAPA payment period as specified in § 413.234(c)(1) would continue in CY 2025: Jesduvroq (daprodustat) that was approved for the TDAPA effective in CY 2023 and DefenCath® (taurolidine and heparin sodium) that was approved for the TDAPA effective in CY 2024. Table 11 also identifies the products' HCPCS coding information as well as the payment adjustment effective dates and end dates.
The Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27) was enacted on June 29, 2015, and amended the Act to provide coverage and payment for dialysis furnished by an ESRD facility to an individual with AKI. Specifically, section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the TPEA amended section 1834 of the Act by adding a subsection (r) to provide payment, beginning January 1, 2017, for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate, as adjusted by any applicable geographic adjustment applied under section 1881(b)(14)(D)(iv)(II) of the Act and adjusted (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under section 1881(b)(14)(D) of the Act that the Secretary elects.
In the CY 2017 ESRD PPS final rule, we finalized several coverage and payment policies to implement subsection (r) of section 1834 of the Act and the amendments to section 1861(s)(2)(F) of the Act, including the payment rate for AKI dialysis (81 FR 77866 through 77872 and 77965). We interpret section 1834(r)(1) of the Act as requiring the amount of payment for AKI dialysis services to be the base rate for renal dialysis services determined for a year under the ESRD PPS base rate as set forth in § 413.220, updated by the ESRD bundled market basket percentage increase factor minus a productivity adjustment as set forth in § 413.196(d)(1), adjusted for wages as set forth in § 413.231, and adjusted by any other amounts deemed appropriate by the Secretary under § 413.373. We codified this policy in § 413.372 (81 FR 77965).
In the CY 2017 ESRD PPS final rule, we indicated that we did not expect beneficiaries with AKI to dialyze at home; therefore, the home dialysis benefit was not extended to beneficiaries with AKI (81 FR 77870). There were commenters who advocated for beneficiaries to have the option to dialyze in a home setting, particularly those beneficiaries who started peritoneal dialysis (PD) in the hospital and desired to continue PD after discharge. However, other commenters indicated that beneficiaries with AKI needed close supervision during dialysis. Additionally, some commenters indicated that dialysis for AKI is a short-term treatment, and beneficiaries would not have time to learn to administer a home therapy. Therefore, we finalized the AKI payment policy in the CY 2017 ESRD PPS final rule as proposed without extending the AKI benefit to home dialysis beneficiaries. We indicated that we would gather data on the AKI population and the extent of home training necessary to safely self-administer dialysis in the home, and that we would consider the use of home dialysis for beneficiaries with AKI in the future as we find that it may be beneficial for subsets of beneficiaries.
In past years we have received comments regarding the site of renal dialysis services for Medicare beneficiaries with AKI, with the most recent comments received in response to the CY 2024 ESRD PPS proposed rule to update to the AKI dialysis payment rate (88 FR 76433). We have monitored data for beneficiaries with AKI and researched data in journal articles discussing the potential to expand dialysis for beneficiaries with AKI to a home setting, as noted in the CY 2017 ESRD PPS final rule (81 FR 77871).
In the CY 2017 ESRD PPS final rule, we clarified that the ESRD Facility Conditions for Coverage (CfCs) apply to ESRD facilities, not to ESRD beneficiaries, and noted that the ESRD facility CfCs would be the appropriate regulatory location for standards addressing care provided to beneficiaries with AKI in ESRD facilities. We finalized a policy that our CfCs would not need to be revised to address the provision of dialysis treatment to beneficiaries with AKI (81 FR 77871 through 77872).
In December 2020, CMS's data contractor held a TEP that considered data related to utilization review and cost of AKI treatments since 2017. The TEP solicited input regarding how reported costs align with realized costs of treatment for beneficiaries with AKI. During the TEP, participants suggested that we extend Medicare payment for beneficiaries with AKI to allow them to dialyze in a home setting. Additionally, the TEP indicated that beneficiaries with AKI could benefit from different treatment regimens. The TEP noted that more frequent, gentler dialysis with a lower ultrafiltration rate would be a viable option for some beneficiaries. Members of the panel commented on the similar treatment frequencies observed for beneficiaries with AKI and ESRD, stating that the payment system is currently constructed to facilitate the standard treatment plan for beneficiaries with AKI. Panelists recommended that the ESRD PPS should be flexible in terms of number of treatments for beneficiaries with AKI, so that those who need more frequent treatments are not impeded from receiving them.
We solicited comments regarding potentially modifying the site of renal dialysis services for beneficiaries with AKI and payment for AKI in the home setting as a RFI in the CY 2022 ESRD PPS proposed rule (86 FR 36322, 36408). We received 16 comments from LDOs, patient advocacy groups, professional organizations, small dialysis organization within a large non-profit health system, and non-profit organizations. Most of the comments favored providing a payment option for beneficiaries with AKI to dialyze in a home setting; however, some commenters expressed concerns about doing so. A small dialysis organization within a large non-profit health system indicated that beneficiaries with AKI may have chronic kidney disease at a lesser stage, such as, Stage 3 or Stage 4 chronic kidney disease (CKD) rather than ESRD; however, the AKI makes dialysis necessary. This commenter noted that if the AKI were to cause the beneficiary's underlying Stage 3 or Stage 4 CKD to progress to ESRD in the future, training them to use a home modality during the AKI episode could prepare the patient for a home modality if they are diagnosed as having ESRD. One LDO indicated there is evidence that PD, which is typically used in the home setting, is associated with better preservation of residual kidney function compared to hemodialysis. A national organization of beneficiaries and kidney health care professionals advocated that PD may be learned quickly, reduces rapid hemodynamic changes that may potentiate kidney injury and impede recovery, and does not require a high-risk central venous catheter to provide treatment. We note that these comments are specific to PD as a treatment modality; however, when considering such a policy we would include payment for both PD and hemodialysis (HD) in the home setting for beneficiaries with AKI, consistent with our payment policy for home dialysis for patients with ESRD.
Most recently, as noted in the CY 2024 ESRD PPS final rule (88 FR 76433), we received 10 public comments on our proposal to update the payment rate for renal dialysis services furnished to individuals with AKI. Commenters included a coalition of dialysis organizations, a non-profit dialysis organization, a trade association, a renal product development company, and multiple large dialysis organizations. Most of the commenters requested that we allow payment for beneficiaries with AKI to select home dialysis modalities by changing the current policy, even though it was not proposed in the CY 2024 ESRD PPS proposed rule.
We acknowledge there have been concerns in the past regarding the safety of beneficiaries with AKI dialyzing at home. However, we have carefully reviewed the totality of the information and evidence presented to the agency and now recognize that current information regarding beneficiaries with AKI dialyzing in a home setting supports more frequent dialysis at a lower ultrafiltration rate. The ability to dialyze at a lower ultrafiltration rate supports a decrease in hemodynamic fluctuation and the complications associated with it, which in turn support recovery of kidney function.
Although there is only limited research regarding the use of home dialysis for the treatment of AKI, we note that several studies support the use of home dialysis to generally improve access to dialysis and provide care that better meets patient needs. We note that many of the studies related to home dialysis in the AKI patient population use PD as the treatment modality, which is consistent with comments received during the December 2020 TEP and comments received during rulemaking as noted previously. Additionally, data from the United States Renal Data System (USRDS) Annual Data Report (ADR), indicates the percentage of incident dialysis patients performing home HD was only 0.4 percent in 2021, and a significant majority of dialysis patients performing home dialysis chose PD.
The International Society for Peritoneal Dialysis (ISPD) reiterated in the 2020 guidelines, updated from the 2014 guidelines for PD in AKI, that PD should be considered a suitable modality for treatment of AKI in all settings. This was a strong recommendation from the ISPD based on evidence rated at the second highest level used by ISPD.
Admittedly, most studies regarding recovery of kidney function in patients with AKI are based around hospitalized patients. There are very limited studies suggesting that self-care dialysis can yield faster recovery of kidney function; however, the results are not conclusive.
Further support for this proposal comes from CMS AKI monitoring data, in which we found that current provision of AKI dialysis is very similar to the provision of ESRD dialysis. Data from the 2021 Quarter 4 public use file (PUF)
We believe the proposal to provide payment for beneficiaries with AKI to dialyze in a home setting aligns closely with the CMS Strategic Pillars
As previously discussed, we did not extend the home dialysis benefit to beneficiaries with AKI when initially implementing the benefit (81 FR 77870). However, as discussed in the prior section, we reviewed AKI monitoring data showing that outcomes for anemia, ESA use, and fluid management are not necessarily reflective of the specific, individualized care, and close supervision by qualified staff currently required during the in-center dialysis process. We note research demonstrates the use of PD is correlated with positive outcomes for fluid management and a lower rate of anemia with less utilization of ESAs and iron, as previously discussed. As we stated in the previous section, research related to home dialysis in the AKI patient population has primarily discussed results using PD as the modality; however, we would provide payment for either PD or HD as a home modality. CMS's goal is for beneficiaries with AKI to receive the necessary care to improve their condition, recover kidney function, and be weaned from dialysis treatment. We also note that the literature exhibits a high correlation between the use of PD treatment for beneficiaries with AKI and positive outcomes for fluid management, infection rates, mortality, and recovery of kidney function.
After careful review of current research and the outcomes noted during the COVID-19 PHE, we propose to extend the home dialysis benefit as defined at 42 CFR 410.52 to beneficiaries with AKI for either PD or HD. As discussed in section III.C.1 of this proposed rule, we are proposing that the payment amount for home dialysis for AKI beneficiaries would be the same as the payment amount for in-center dialysis for AKI beneficiaries, consistent with payment parity within the ESRD PPS. This payment amount
We are proposing to amend § 410.52 to provide Medicare payment for the treatment of patients with AKI in the home setting. We are proposing to revise § 410.52 to read “Medicare Part B pays for the following services, supplies, and equipment furnished to a patient with ESRD or an individual with Acute Kidney Injury (AKI) as defined in § 413.371 of this chapter in his or her home:” by striking the words “an ESRD patient” after “to” and adding the words “a patient with ESRD or an individual with Acute Kidney Injury (AKI) as defined in § 413.371 of this chapter” after “to”. We are also proposing to revise § 413.374(a) to read: “The AKI dialysis payment rate applies to renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or provider of services paid under section 1881(b)(14) of the Act, including home services, supplies, and equipment, and self-dialysis.”
The payment rate for AKI dialysis is the ESRD PPS base rate determined for a year under section 1881(b)(14) of the Act, which is the finalized ESRD PPS base rate, including the applicable annual market basket update, geographic wage adjustments, and any other discretionary adjustments, for such year. We note that ESRD facilities could bill Medicare for non-renal dialysis items and services and receive separate payment in addition to the payment rate for AKI dialysis. As discussed in section II.B.4 of this proposed rule, the proposed ESRD PPS base rate is $273.20, which reflects the application of the proposed CY 2025 wage index budget-neutrality adjustment factor of 0.990228 and the proposed CY 2025 ESRDB market basket percentage increase of 2.3 percent reduced by the proposed productivity adjustment of 0.5 percentage point, that is, 1.8 percent. Accordingly, we are proposing a CY 2025 per treatment payment rate of $273.20 (($271.02 × 0.990228) × 1.018 = $273.20) for renal dialysis services furnished by ESRD facilities to individuals with AKI. This proposed payment rate is further adjusted by the wage index, as discussed in the next section of this proposed rule.
Under section 1834(r)(1) of the Act and regulations at § 413.372, the amount of payment for AKI dialysis services is the base rate for renal dialysis services determined for a year under section 1881(b)(14) of the Act (updated by the ESRDB market basket percentage increase and reduced by the productivity adjustment), as adjusted by any applicable geographic adjustment factor applied under section 1881(b)(14)(D)(iv)(II) of the Act. Accordingly, we apply the same wage index under § 413.231 that is used under the ESRD PPS. As discussed in section II.B.2.b of this proposed rule, we are proposing a new ESRD PPS wage index methodology, which utilizes BLS OEWS data and freestanding ESRD facility cost report data. We are proposing to use this same methodology when adjusting AKI dialysis payments to ESRD facilities, consistent with our historical practice of using the ESRD PPS wage index for AKI dialysis payments. The AKI dialysis payment rate is adjusted by the wage index for a particular ESRD facility in the same way that the ESRD PPS base rate is adjusted by the wage index for that ESRD facility (81 FR 77868). Specifically, we apply the wage index to the labor-related share of the ESRD PPS base rate that we utilize for AKI dialysis to compute the wage adjusted per-treatment AKI dialysis payment rate. We also apply the wage index policies regarding the 0.600 wage index floor (87 FR 67161 through 67166) and the 5 percent cap on wage index decreases (87 FR 67159 through 67161) to AKI dialysis payments to ESRD facilities. ESRD facilities would utilize the same staff to provide renal dialysis services to and educate beneficiaries with AKI as those beneficiaries with ESRD. Therefore utilizing the same wage index methodology would be appropriate in accordance with § 413.372, which addresses the payment rate for AKI dialysis and refers to § 413.231 for the wage adjustment. As stated previously, we are proposing a CY 2025 AKI dialysis payment rate of $273.20, adjusted by the ESRD facility's wage index.
Section 1834(r)(1) also provides that the payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r)) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act. As discussed in the previous section, we are proposing to extend AKI dialysis payment to home dialysis.
In implementing payment for home dialysis in the AKI patient population, we considered our existing payment policies for home dialysis for beneficiaries with ESRD. In the CY 2011 ESRD PPS final rule, we explained that although we included payments for providing training to beneficiaries in computing the ESRD PPS base rate, we agreed with commenters that we should pay for home dialysis training as an add-on payment adjustment under the ESRD PPS to account for the cost of providing training to beneficiaries on the use of home dialysis modalities. Thus, we finalized the home dialysis training add-on payment adjustment of $33.44 per treatment as an additional payment made under the ESRD PPS when one-on-one home dialysis training is furnished by a nurse for either hemodialysis or peritoneal dialysis training and retraining (75 FR 49063). We clarified our policy on payment for home dialysis training again in the CY 2013 ESRD PPS final rule, in which we stated that training costs are included in the ESRD PPS base rate; however, we also provide an add-on payment adjustment for each home and self-dialysis training treatment furnished by a Medicare-certified home dialysis training facility (77 FR 67468). We explained in the CY 2017 ESRD PPS final rule that it is not the intent of the add-on treatment to reimburse a facility
We considered making payment for home dialysis for beneficiaries with AKI under the ESRD PPS base rate without an add-on payment adjustment for home modality training. As we noted in the background section, the ESRD PPS base rate upon which the AKI dialysis payment rate is established contains monies for training related costs. However, we are concerned that not providing a home and self-dialysis training add-on payment adjustment for AKI dialysis may limit access to home dialysis care for the AKI beneficiary population. As previously noted, incorporation of an adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act into AKI dialysis payments must be done on a budget neutral basis for payments under section 1834(r) of the Act. Therefore, establishing an add-on adjustment for training for home and self-care dialysis could have an impact on the AKI base rate.
We have reviewed options for applying budget neutrality to a home and self-dialysis training add-on payment adjustment for beneficiaries with AKI. We are considering applying a budget neutrality adjustment factor by reducing the AKI dialysis payment rate amount (which is based on the ESRD PPS base rate and is then adjusted for wages according to § 413.372) for renal dialysis services provided to patients with AKI to account for the add-on training adjustment. For example, we might estimate utilization of home dialysis in the AKI patient population using ESRD PPS data and on that basis derive a budget neutrality adjustment factor to apply to the AKI payment rate that would ensure that total payments to ESRD facilities for renal dialysis services provided to patients with AKI do not increase as a result of implementing the home and self-dialysis add-on training adjustment. To develop an estimate for consideration we used publicly available data to build an example. Using the fourth quarter data from the 2022 ESRD PUF,
However, this option would entail that the ESRD PPS base rate would not be equal to the AKI dialysis payment rate once the budget neutrality adjustment factor is applied, which could disincentivize ESRD facilities from treating patients who have AKI. Additionally, we do not have utilization data for home and self-dialysis in the AKI beneficiary population. Therefore, any initial budget neutrality adjustment to the AKI dialysis payment rate would require an estimation as in the potential equation described previously. We are further considering whether, if we apply a budget neutrality adjustment factor to the AKI payment rate based on an estimation, we should reconcile payments to ESRD facilities for renal dialysis services provided to patients with AKI later to modify the budget neutrality adjustment factor based on actual utilization data.
Due to these constraints, we are seeking comments regarding the need for a home and self-dialysis training add-on payment adjustment for AKI beneficiaries along with suggestions on how to budget neutralize the add-on payment adjustment for home and self-dialysis training for AKI beneficiaries considering the statutory requirement. Additionally, we are soliciting comments on other venues in which beneficiaries with AKI might receive training for home and self-dialysis, such as inpatient or outpatient hospital departments or nephrologist offices.
We propose, in accordance with section 1834(r)(1) of the Act and § 413.373, to extend the home and self-dialysis training add-on payment adjustment under § 413.235(c) to payments for renal dialysis services provided to beneficiaries with AKI using a home modality. We propose to make payment for a home and self-dialysis add-on training adjustment at the same amount currently applicable under the ESRD PPS of $95.57 with a limit of 15 training treatments for PD and a limit of 25 training treatments for HD per patient excluding retraining sessions (75 FR 49063). Additional information regarding the maximum number of training treatments for which CMS provides payment under the ESRD PPS is located in the Medicare Claims Processing Manual.
ESRD is a kidney impairment that is irreversible and permanent. Dialysis is a process for cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. People with ESRD require either a regular course of dialysis or kidney transplantation to live. Given the high costs and absolute necessity of transplantation or dialysis for people with failed kidneys, Medicare provides health care coverage to qualifying individuals diagnosed with ESRD, regardless of age, including coverage for kidney transplantation, maintenance dialysis, and other health care needs. AKI is an acute decrease in kidney function due to kidney damage or kidney failure that may require dialysis. Unlike people with ESRD, individuals with AKI who require dialysis are expected to regain kidney function within three months. People with either ESRD or AKI can receive outpatient dialysis services from Medicare-certified ESRD facilities, also called dialysis facilities.
The Medicare ESRD program became effective July 1, 1973, and initially operated under interim regulations published in the
Medicare pays for routine maintenance dialysis provided by Medicare-certified ESRD facilities, also known as dialysis facilities. To gain certification, the State survey agency performs an on-site survey of the facility to determine if it meets the ESRD CfCs at 42 CFR part 494. If a survey indicates that a facility is in compliance with the conditions, and all other Federal requirements are met, CMS then certifies the facility as qualifying for Medicare payment. Medicare payment for outpatient maintenance dialysis is limited to facilities meeting these conditions. As of March 2024, there are approximately 7,700 Medicare-certified dialysis facilities in the United States,
The ESRD CfCs found at 42 CFR part 494, consist of the health and safety standards that all Medicare participating dialysis facilities must meet. These standards set baseline requirements for patient safety, infection control, care planning, staff qualifications, record keeping, and other matters to ensure that all patients with kidney failure receive safe and appropriate care. In addition, the CfCs require patients to be informed about all treatment modalities (hemodialysis or peritoneal dialysis) and settings (home dialysis modalities or in-facility hemodialysis) (§ 494.70(a)(7)). A dialysis facility that is certified to provide services to home patients must ensure that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable conditions of § 494.100. The patient's interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in § 494.10). Dialysis facilities monitor home dialysis by documenting adequate comprehension of the training; retrieving and reviewing complete self-monitoring data and other information at least every two months; and maintaining this information in the patient's medical record.
In the CY 2017 ESRD PPS final rule (81 FR 77834), we clarified that ESRD facility CfCs apply to ESRD facilities, not to people with ESRD, and noted that the ESRD CfCs would be the appropriate regulatory location for standards addressing care provided to beneficiaries with AKI in ESRD facilities. While the language of the ESRD CfCs does not directly address treatment of beneficiaries with AKI, we believe that the current ESRD facility requirements are sufficient to ensure that such patients are dialyzed safely. For example, infection control protocols are the same for any individual receiving hemodialysis, regardless of the cause or likely trajectory of their kidney disfunction. For the areas in which care and care planning may differ, such as frequency of certain patient assessments, we note that the CfCs set baseline standards and do not limit additional or more frequent services that may be necessary for beneficiaries with AKI receiving temporary dialysis as they recover kidney function.
During the development of the CY 2017 ESRD PPS final rule, we did not anticipate that beneficiaries with AKI would be candidates for home dialysis due to the likely short-term duration of treatment and the unique needs of AKI. Specifically, it was our understanding that beneficiaries with AKI require supervision by qualified staff during their dialysis and close monitoring through laboratory tests, often conducted more frequently than for people with ESRD, to ensure that they are receiving appropriate care as their kidney function improves. Therefore, we did not propose to extend the home dialysis benefit to beneficiaries with AKI at that time (81 FR 77870). However, for the reasons discussed in section III of this proposed rule, we are proposing to extend coverage of home dialysis services to beneficiaries with AKI, allowing them flexibility in choosing their preferred treatment modality. The choice between home and in-center dialysis reflects a combination
The United States Renal Data System 2023 Annual Data Report (ADR) contains updated information about the chronic kidney disease and ESRD populations in the U.S. through the end of 2021; the statistics in this section were published in this report.
Under current Medicare regulations, ESRD facility beneficiaries with AKI are restricted to receiving in-center hemodialysis, regardless of their individual prognosis or course of treatment prior to hospital discharge.
Hemodialysis (HD) is the modality most often initiated by hospital staff for urgent start patients, but often the patient is discharged to an in-center clinic. Given a choice, most patients with ESRD prefer home dialysis over in-center hemodialysis. Peritoneal dialysis (PD) is a home dialysis method and offers benefits such as absence of central venous access and therefore preservation of veins, low cost, and decreased time per dialysis session, as well as convenience.
The current policies restricting access to home dialysis modalities for beneficiaries with AKI perpetuate current inequities in dialysis experiences. The percentage of all-cause hospitalizations of beneficiaries with AKI is consistently higher among older populations, men, and Black beneficiaries.
There is a disproportionate lack of home dialysis for low-income communities and communities of color. This data includes all dialysis beneficiaries, not just those with AKI. Patients in all race/ethnicity groups living in neighborhoods with more deprivation are less likely to initiate dialysis at home. The ADR shows White and Asian patients were substantially more likely to dialyze at home than Black and Hispanic patients.
By providing multiple choices of dialysis modality (in-center dialysis, PD, or HHD), patients can choose which one best suits their needs. Solutions that encourage and facilitate initiation of home education and training in the hospital by nephrologists, dialysis nurses and hospital social workers, could significantly increase the adoption of home dialysis for beneficiaries with AKI. Initially, in the CY 2017 ESRD PPS final rule, we expressed concern about beneficiaries with AKI receiving dialysis at home, particularly PD, due to the unique medical needs of the patients; we finalized the rule as proposed without extending the AKI benefit to home dialysis patients (81 FR 77870). As discussed in section III.C.1 of this proposed rule, we have received comments regarding the site of renal dialysis services for Medicare beneficiaries with AKI. Over the years, we have monitored data for beneficiaries with AKI and research discussing the potential to expand dialysis for beneficiaries with AKI to a home setting. In addition, during the COVID-19 PHE, many patients who developed AKI received home dialysis successfully.
To support treatment location choices for individuals with AKI requiring dialysis and to align with the proposed coverage changes, we propose conforming changes throughout the ESRD CfCs at 42 CFR part 494 to clarify that the option for home dialysis services is available to all patients. Specifically, we note that the phrase “ESRD patients” is exclusive of beneficiaries with AKI. The phrase “kidney failure” is inclusive of people whose kidney function is inadequate such that dialysis is necessary to maintain or prolong life. This can be a temporary (AKI) or permanent (ESRD) condition. Accordingly, we are proposing to amend the definitions of home dialysis and self-dialysis at §§ 494.10, 494.70(c)(1)(i), and 494.130 introductory text by removing the descriptor “ESRD.” In addition, we are proposing to amend §§ 494.70(a)(1) and (10) and 494.80 introductory text by revising the phrase “ESRD” to say “kidney failure;” § 494.90(b)(4) by revising the phrase “ESRD care” to say “dialysis care;” § 494.100(a)(3)(i) by revising the phrase “management of ESRD” to say “management of their kidney failure;” § 494.120 introductory text by revising the phrase “serve ESRD patients” to say “serve patients with kidney failure;” and lastly § 494.170 introductory text by revising the phrase “provider of ESRD services” to say “provider of dialysis services.” We welcome comments on these proposed changes. Specifically, are these proposed revisions adequate to ensure access to home dialysis services for individuals with AKI?
Beneficiaries with AKI requiring dialysis represent a small subset of individuals treated in outpatient dialysis facilities. Specifically, around 12,000 patients would be eligible for this optional service.
For a detailed discussion of the ESRD QIP's background and history, including a description of the Program's authorizing statute and the policies that we have adopted in previous final rules, we refer readers to the citations provided at IV.A of the CY 2024 ESRD PPS final rule (88 FR 76433). We have also codified many of our policies for the ESRD QIP at 42 CFR 413.177 and 413.178.
In this proposed rule, we are proposing to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure, a comprehensive measure on which facilities are scored for each payment year using one set of performance standards, with a Kt/V measure topic comprised of four individual Kt/V measures, beginning with PY 2027.
Section 1881(h)(2)(A)(i) states that the ESRD QIP must evaluate facilities based on measures of dialysis adequacy. Beginning with the PY 2027 ESRD QIP, we are proposing to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure, a single comprehensive measure on which facility performance is calculated using one set of performance standards for each payment year, with a Kt/V Dialysis Adequacy Measure Topic, a measure topic comprised of four individual Kt/V measures on which facility performance is calculated using performance standards for each individual Kt/V measure.
By replacing the current Kt/V Dialysis Adequacy Comprehensive clinical measure with four separate measures, we would be able to assess Kt/V performance more accurately based on whether the patient is an adult or child and what type of dialysis the patient is receiving. We are also proposing to score the four measures as a Kt/V Dialysis Adequacy Measure Topic and to limit the total weight of that topic to 11 percent of the TPS, which is the weight of the current Kt/V Dialysis Adequacy Comprehensive clinical measure. These proposals would continue to maintain Kt/V measurement as an important part of the quality of care assessed by the ESRD QIP. Facilities are eligible to receive an individual Kt/V measure score if they treat at least 11 eligible patients using the modality addressed by that particular measure. For example, a facility treating at least 11 eligible pediatric HD patients during the applicable performance period would be scored on the Kt/V Pediatric HD measure. We would calculate a facility's measure topic score by first calculating the facility's performance on each of the Adult HD Kt/V, Adult PD Kt/V, Pediatric HD Kt/V, and Pediatric PD Kt/V measures, as applicable, using the applicable achievement threshold, benchmark, and improvement threshold for the payment year. Second, we would calculate the total number of eligible patients for weighting each of these measure scores to calculate a single measure topic score. We would calculate this total number by summing all eligible patients included in the denominator for each individual measure. Third, we would calculate the weighted score for each measure within the measure topic by dividing the number of patients included in the denominator for each individual measure by the total number of eligible patients for all of the measures within the measure topic and multiplying by the respective measure score. Finally, we would add the weighted measure scores together and round them to the nearest integer. An example of how we would calculate the measure topic score for a facility that treats the minimum number of patients to be eligible for scoring on all four of the measures is provided below.
Under our proposal, a facility would not need to be eligible for scoring on all four individual measures to receive a measure topic score. For example, a facility that exclusively treats adult HD patients and, for that reason, is eligible to be scored on only the Kt/V Adult HD measure would receive a topic score that is the same score as its individual Kt/V measure score. The proposed measure topic scoring considers both a facility's individual ESRD patient population and the treatment modalities it offers, and then weights its performance on the topic proportionately to its overall ESRD patient population. As a result, we believe that a facility's measure topic score will be more reflective of its actual performance among its patient population and offered modalities than its current Kt/V Dialysis Adequacy Comprehensive clinical measure score, which is a composite assessment that blends the Kt/V measure data of all patients treated at that facility.
We previously adopted a Kt/V Dialysis Adequacy Measure Topic that included three of the four measures that we are now proposing to include in the topic (adult HD Kt/V, adult PD Kt/V, and pediatric HD Kt/V) in the CY 2013 ESRD PPS final rule (77 FR 67487 through 67490). In the CY 2015 ESRD PPS final rule (79 FR 66197 through 66198), we updated the Kt/V Dialysis Adequacy Measure Topic to include the pediatric PD Kt/V measure as well. In the CY 2016 ESRD PPS final rule (80 FR 69053 through 69057), we replaced the Kt/V Dialysis Measure Topic with the current Kt/V Dialysis Adequacy Comprehensive clinical measure, which assesses the percentage of all patient-months for both adult and pediatric patients whose average delivered dose of dialysis (either hemodialysis or peritoneal dialysis) met the specified threshold during the performance period. This change allowed more facilities to be eligible for measure
At the time we finalized the Kt/V Dialysis Adequacy Comprehensive clinical measure, three facilities were eligible for scoring on the pediatric HD Kt/V measure, six facilities were eligible for scoring on the pediatric PD Kt/V measure, 1,402 facilities were eligible for scoring on the adult PD Kt/V measure, and 6,117 facilities were eligible for scoring on the adult HD Kt/V measure. Given the relatively low numbers of facilities eligible for scoring on the pediatric HD Kt/V, pediatric PD KT/V, and adult PD Kt/V measures at that time, we adopted the Kt/V Dialysis Adequacy Comprehensive clinical measure to help ensure that data reflecting those patient populations contributed to facilities' total performance scores. Since the CY 2016 ESRD PPS final rule, however, Kt/V measure data (using the PY 2024/CY 2022 ESRD QIP eligible facility list, CY 2022 EQRS data, and CY 2022 claims data) indicates that more facilities are treating greater numbers of pediatric HD patients and pediatric PD patients, as well as greater numbers of adult PD patients, and therefore would be eligible to be scored on the individual measures based on an 11-patient case minimum. For example, there are now 21 pediatric HD facilities and 28 pediatric PD facilities with at least 11 qualifying patients. This shows a 600 percent increase in facilities eligible to be scored on the pediatric HD Kt/V measure, and a 366 percent increase in facilities eligible to be scored on the pediatric PD Kt/V measure, since the CY 2016 ESRD PPS final rule. Additionally, there are now 2,538 facilities eligible for scoring on the adult PD Kt/V measure, an 81 percent increase since the CY 2016 ESRD PPS final rule. By contrast, the number of facilities eligible for scoring on the adult HD Kt/V measure has increased by 14 percent during that same period of time.
In light of the increase in the proportions of pediatric HD patients, pediatric PD patients, and adult PD patients being treated at ESRD facilities since the time we adopted the Kt/V Dialysis Adequacy Comprehensive clinical measure, we have determined that it is appropriate and more reflective of facility performance to reintroduce the Kt/V Dialysis Adequacy Measure Topic in the ESRD QIP. In addition, the proposed measure topic scoring methodology will more accurately capture facility performance with respect to dialysis adequacy because it assesses those facilities based on performance standards tailored according to Kt/V measurements that reflect ESRD patient age and treatment modality.
The proposed replacement of the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic would also not affect a facility's measure data reporting requirements. A facility would continue to report the same Kt/V measure data into EQRS and Medicare claims as it would for the current Kt/V Dialysis Adequacy Comprehensive clinical measure. However, under the proposed Kt/V Dialysis Adequacy Measure Topic, the measure data would be used to score the facility on four individual Kt/V measures, as applicable based on their ESRD patient population and treatment modalities.
The proposed replacement of the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic would also advance the CMS National Quality Strategy Goals by scoring facilities on measure data that more accurately reflects the quality of care provided to different kinds of ESRD patients on different treatment modalities. The proposed Kt/V Dialysis Adequacy Measure Topic would allow us to evaluate dialysis adequacy in adult HD patients, adult PD patients, pediatric HD patients, and pediatric PD patients by scoring facilities in a way that accounts for differences in patient populations and treatment modalities. Therefore, this proposed update would ensure that a facility's performance on the measure topic more accurately reflects the quality of care provided by the facility.
We welcome public comment on this proposal to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic consisting of an adult HD Kt/V measure, an adult PD Kt/V measure, a pediatric HD Kt/V measure, and a pediatric PD Kt/V measure, for the PY 2027 ESRD QIP and subsequent years.
To ensure continued impact and effectiveness of our measure set on facility performance, we are proposing to remove the NHSN Dialysis Event reporting measure beginning with PY 2027. When we first adopted the NHSN Dialysis Event reporting measure in the CY 2012 ESRD PPS final rule (76 FR 70268 through 70269), we stated that reporting dialysis events to the NHSN by all facilities supports national goals for patient safety, including the reduction of Hospital Acquired Infections (HAIs). In the CY 2014 ESRD PPS final rule, we replaced the NHSN Dialysis Event reporting measure with the NHSN Bloodstream Infection (BSI) clinical measure (78 FR 72204 through 72207). We introduced the clinical version of the measure to hold facilities accountable for monitoring and preventing infections in the ESRD population, and to hold facilities accountable for their actual clinical performance on the measure. In the CY 2017 ESRD PPS final rule (81 FR 77879 through 77882), we reintroduced the NHSN Dialysis Event reporting measure to complement the NHSN BSI clinical measure as a way to incentivize facilities to report complete and accurate monthly dialysis event data in compliance with the NHSN Dialysis Event protocol.
Based on our analyses, facilities are consistently reporting monthly dialysis event data, and have been doing so for several years. In an assessment of ESRD QIP measure rate performance trends during PY 2020 through PY 2022, performance in the 5th percentile through the 100th percentile was 100 percent on the NHSN Dialysis Event reporting measure for all three performance years, meaning that most eligible facilities reported data on the measure for each of those years.
Our proposal to remove the NHSN Dialysis Event reporting measure is consistent with evolving the program to focus on a measure set of high-value, impactful measures that have been developed to drive care improvements for a broader set of ESRD patients. As such, we are proposing to remove this measure from the ESRD QIP measure set under § 413.178(c)(5)(i)(A), Measure Removal Factor 1 (measure performance among the majority of ESRD facilities is so high and unvarying that meaningful distinctions in improvements or performance can no longer be made). Although we believe that removing this measure would enable facilities to focus on the remaining measures in the ESRD QIP measure set, we note that facilities would still be required to fully comply with the NHSN Dialysis Event protocol and report all dialysis event data, including BSI, for the NHSN BSI Clinical Measure.
We welcome public comment on our proposal to remove the NHSN Dialysis Event reporting measure from the ESRD QIP measure set, beginning with PY 2027.
In the CY 2024 ESRD PPS final rule (88 FR 76481 through 76482), we finalized revisions to the ESRD QIP measure domains beginning with PY 2027. The measure domains and weights we finalized in the CY 2024 ESRD PPS final rule are depicted in table 13a.
In this proposed rule, we are proposing to revise the Clinical Care Domain beginning with PY 2027 to reflect our proposal to replace the Kt/V Comprehensive Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic, and to revise the measure weights in the Reporting Measure Domain to reflect our proposal to remove the NHSN Dialysis Event reporting measure from the ESRD QIP measure set. Under our proposal, the weight of the Kt/V Dialysis Adequacy Topic would continue to be the same as the current weight of the Kt/V Dialysis Adequacy Comprehensive Measure, but that weight would be applied to a facility's measure topic score, instead of being applied, as it is now, to a facility's score on the single Kt/V Comprehensive Dialysis Adequacy Comprehensive clinical measure.
Given our proposal to remove the NHSN Dialysis Event reporting measure from the ESRD QIP beginning with PY 2027, we are also proposing to update the individual measure weights in the Reporting Domain to accommodate the proposed new number of measures. Consistent with our approach in the CY 2023 ESRD PPS final rule, we are proposing to assign individual measure weights to reflect the proposed updated number of measures in the Reporting Measure Domain so that each measure is weighted equally (87 FR 67251
We welcome public comment on these proposals to update the Clinical Care Measure Domain and Reporting Measure Domain.
Section 1881(h)(4)(A) of the Act requires the Secretary to establish performance standards with respect to the measures selected for the ESRD QIP for a performance period with respect to a year. The performance standards must include levels of achievement and improvement, as determined appropriate by the Secretary, and must be established prior to the beginning of the performance period for the year involved, as required by sections 1881(h)(4)(B) and (C) of the Act. We refer readers to the CY 2013 ESRD PPS final rule (76 FR 70277), as well as § 413.178(a)(1), (3), (7), and (12), for further information related to performance standards.
In the CY 2024 ESRD PPS final rule (88 FR 76480 through 76481), we set the performance period for the PY 2027 ESRD QIP as CY 2025 and the baseline period as CY 2023. In this proposed rule, we are estimating the performance standards for the PY 2027 clinical measures in table 14 using data from CY 2022, which are the most recent data available. We intend to update these performance standards for all measures, using CY 2023 data, in the CY 2025 ESRD PPS final rule.
In addition, we summarize in table 15 our requirements for successful reporting on our previously finalized reporting measures for the PY 2027 ESRD QIP.
In this proposed rule, we are proposing to update eligibility requirements as part of our proposal to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic beginning with PY 2027. Our previously finalized and proposed new minimum eligibility requirements are described in table 16.
We welcome public comment on these proposals to update the minimum eligibility requirements to reflect the proposed Kt/V Dialysis Adequacy Measure Topic.
Under our current policy, a facility does not receive a payment reduction for a payment year in connection with its performance under the ESRD QIP if it achieves a TPS that is at or above the minimum TPS (mTPS) that we establish for the payment year. We have defined the mTPS in our regulations at § 413.178(a)(8).
Under § 413.177(a), we implement the payment reductions on a sliding scale using ranges that reflect payment reduction differentials of 0.5 percent for each 10 points that the facility's TPS falls below the mTPS, up to a maximum reduction of 2 percent. For PY 2027, we estimate using available data that a facility must meet or exceed an mTPS of 51 to avoid a payment reduction. We note that the mTPS estimated in this proposed rule is based on data from CY 2022 instead of the PY 2027 baseline period (CY 2023) because CY 2023 data are not yet available. We will update and finalize the mTPS and associated payment reduction ranges for PY 2027, using CY 2023 data, in the CY 2025 ESRD PPS final rule.
As discussed in the following sections, we are requesting information on two topics to inform future revisions to the ESRD QIP. First, we are requesting information regarding potential future modifications to the existing ESRD QIP scoring methodology to reward facilities based on their performance and the proportion of their patients who are dually eligible for Medicare and Medicaid. Second, we are requesting information regarding potential updates to the data validation policy to encourage accurate, comprehensive reporting of ESRD QIP data.
Please note that each of these sections in this proposed rule is an RFI only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), these general solicitations are exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the
Respondents are encouraged to provide complete but concise responses. These RFIs are issued solely for information and planning purposes; they do not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. These RFIs do not commit the United States Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through these RFIs and will not accept unsolicited proposals. Responders are advised that the United States Government will not pay for any information or administrative costs incurred in response to these RFIs; all costs associated with responding to these RFIs will be solely at the interested party's expense. Not responding to these RFIs does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor these RFI announcements for additional information pertaining to this request. Please note that we will not respond to questions about the policy issues raised in these RFIs. CMS may or may not
Achieving health equity, addressing health disparities, and closing the performance gap in the quality of care provided to disadvantaged, marginalized, or underserved populations continue to be priorities for CMS as outlined in the CMS National Quality Strategy.
The ESRD QIP adopted three new health-equity focused quality measures in the CY 2024 ESRD PPS final rule (88 FR 76437 through 76446; 76466 through 76480). Although commenters were generally supportive of the new measures, a few commenters recommended that the ESRD QIP take additional action to support facilities that treat patient populations with higher proportions of health-related social needs (HRSNs) (88 FR 76473). We are considering updating our scoring methodology in future rulemaking to add Health Equity Adjustment bonus points to a facility's TPS that would be calculated using a methodology that incorporates a facility's performance across all five domains for the payment year and its proportion of patients with dual eligibility status (DES), meaning those who are eligible for both Medicare and Medicaid coverage.
In the 2016 Report to Congress on Social Risk Factors and Performance Under Medicare's Value-Based Purchasing Programs, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) reported that beneficiaries with social risk factors had worse outcomes and were more likely to receive a lower quality of care.
We recently finalized a Health Equity Adjustment scoring policy for the Hospital Value-Based Purchasing (VBP) Program (88 FR 59092 through 59106) and the Skilled Nursing Facility (SNF) VBP Program (88 FR 53304 through 53316). These policies provide Health Equity Adjustment bonus points to top tier performing hospitals and SNFs with a high proportion of patients with DES, and each program's policy is tailored to meet the needs of the specific program. For example, in the Hospital VBP Program, the Health Equity Adjustment bonus is calculated based on a hospital's performance on each of the four measure domains and its proportion of patients with DES (88 FR 59095 through 59096). In the SNF VBP Program, the Health Equity Adjustment bonus is calculated based on a facility's performance on each measure and its proportion of patients with DES (88 FR 53309 through 53311).
Our policy for scoring performance on the ESRD QIP is codified at § 413.178(e). In this proposed rule, we are requesting public comment on potential future modifications to the existing scoring methodology to reward excellent care to underserved populations. We also note that any Health Equity Adjustment bonus for the ESRD QIP would need to align with the Program's statutory requirements under section 1881(h) of the Act. We welcome public comment on the following:
• Would a Health Equity Adjustment be valuable to the ESRD QIP?
++ If a Health Equity Adjustment would be valuable to the ESRD QIP, how should it be structured?
++ If a Health Equity Adjustment would not be valuable to the ESRD QIP, why not?
• Are there other approaches that the ESRD QIP could propose to adopt to effectively address healthcare disparities and advance health equity?
One of the critical elements of the ESRD QIP's success is ensuring that the data submitted to calculate measure scores and TPSs are accurate. The ESRD QIP includes two types of data validation for this purpose: The EQRS data validation (OMB Control Number 0938-1289) and the NHSN validation (OMB Control Number 0938-1340). In the CY 2019 ESRD PPS final rule, we adopted the CROWNWeb (now EQRS) data validation as a permanent feature of the Program (83 FR 57003). In the CY 2020 ESRD PPS final rule, we adopted the NHSN data validation as a permanent feature of the Program (84 FR 60727). Under both data validation policies, we validate EQRS and NHSN data from a sample of facilities randomly selected for validation. If a facility is randomly selected for validation but does not submit the requested records, 10 points are deducted from the facility's TPS.
In this proposed rule, we are requesting public comment on ways to update the data validation policy to encourage accurate, comprehensive reporting of ESRD QIP data. We have reviewed data validation policies in other quality reporting programs such as the Hospital Inpatient Quality Reporting (IQR) Program (81 FR 57180) and the Hospital Outpatient Quality Reporting (OQR) Program (76 FR 74486). These programs have adopted data validation policies that require a hospital selected for data validation to achieve a 75 percent reliability or accuracy threshold to receive full credit for data validation reporting.
We welcome comments on potential future policy proposals that would encourage accurate, comprehensive reporting for data validation purposes, such as introducing a penalty for facilities that do not meet an established reporting or data accuracy threshold, introducing a bonus for facilities that perform above an established reporting or data accuracy threshold, developing targeted education on data validation reporting, or requiring that a facility selected for validation that does not meet an established reporting or data accuracy threshold be selected again the next year.
Section 1115A of the Act authorizes the Innovation Center to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and Children's Health Insurance Program (CHIP) expenditures while preserving or enhancing the quality of care furnished to the beneficiaries of these programs. The purpose of the ETC Model is to test the effectiveness of adjusting certain Medicare payments to ESRD facilities and Managing Clinicians to encourage greater utilization of home dialysis and kidney transplantation, support ESRD Beneficiary modality choice, reduce Medicare expenditures, and preserve or enhance the quality of care. As described in the Specialty Care Models final rule (85 FR 61114), beneficiaries with ESRD are among the most medically fragile and high-cost populations served by the Medicare program. ESRD Beneficiaries require dialysis or kidney transplantation to survive, and the majority of ESRD Beneficiaries receiving dialysis receive hemodialysis in an ESRD facility. However, as described in the Specialty Care Models final rule, alternative renal replacement modalities to in-center hemodialysis, including home dialysis and kidney transplantation, are associated with improved clinical outcomes, better quality of life, and lower costs than in-center hemodialysis (85 FR 61264).
The ETC Model is a mandatory payment model. ESRD facilities and Managing Clinicians are selected as ETC Participants based on their location in Selected Geographic Areas—a set of 30 percent of Hospital Referral Regions (HRRs) that have been randomly selected to be included in the ETC Model, as well as HRRs with at least 20 percent of ZIP codes
Under the ETC Model, ETC Participants are subject to two payment adjustments. The first is the Home Dialysis Payment Adjustment (HDPA), which is an upward adjustment on certain payments made to participating ESRD facilities under the ESRD Prospective Payment System (PPS) on home dialysis claims, and an upward adjustment to the Monthly Capitation Payment (MCP) paid to participating Managing Clinicians on home dialysis-related claims. The HDPA applies to claims with claim service dates beginning January 1, 2021, and ending December 31, 2023.
The second payment adjustment under the ETC Model is the Performance Payment Adjustment (PPA). For the PPA, we assess ETC Participants' home dialysis rates and transplant rates during a Measurement Year (MY), which includes 12 months of performance data. Each MY has a corresponding PPA Period—a 6-month period that begins 6 months after the conclusion of the MY. We adjust certain payments for ETC Participants during the PPA Period based on the ETC Participant's home dialysis rate and transplant rate, calculated as the sum of the transplant waitlist rate and the living donor transplant rate, during the corresponding MY.
Based on an ETC Participant's achievement in relation to benchmarks based on the home dialysis rate and transplant rate observed in Comparison Geographic Areas during the Benchmark Year, and the ETC Participant's improvement in relation to their own home dialysis rate and transplant rate during the Benchmark Year, we would make an upward or downward adjustment to certain payments to the ETC Participant. The magnitude of the positive and negative PPAs for ETC Participants increases over the course of the Model. These PPAs apply to claims with claim service dates beginning July 1, 2022 and ending June 30, 2027.
CMS has modified the ETC Model several times. In the CY 2022 ESRD PPS final rule, we finalized a number of changes to the ETC Model. We adjusted the calculation of the home dialysis rate (86 FR 61951 through 61955) and the transplant rate (86 FR 61955 through 61959) and updated the methodology for attributing Pre-emptive LDT Beneficiaries (86 FR 61950 through 61951). We changed the achievement benchmarking and scoring methodology (86 FR 61959 through 61968), as well as the improvement benchmarking and scoring methodology (86 FR 61968 through 61971). We specified the method and requirements for sharing performance data with ETC Participants (86 FR 61971 through 61984). We also made a number of updates and clarifications to the kidney disease patient education services waivers and made certain related flexibilities available to ETC Participants (86 FR 61984 through 61994). In the CY 2023 ESRD PPS final rule (87 FR 67136) we finalized further changes to the ETC Model. We updated the PPA achievement scoring methodology beginning in the fifth MY of the ETC Model, which began on January 1, 2023 (87 FR 67277 through 67278). We also clarified requirements for qualified staff to furnish and bill kidney disease patient education services under the ETC Model's Medicare program waivers (87 FR 67278 through 67280) and finalized our intent to publish participant-level model performance information to the public (87 FR 67280). In the CY 2024 ESRD PPS final rule (88 FR 76344) we finalized a policy whereby an ETC Participant may seek administrative review of a targeted review determination provided by CMS.
We are proposing a modification to the definition of ESRD Beneficiary at 42 CFR 512.310 as that definition is used for the purposes of attributing beneficiaries to the ETC Model. As finalized in the Specialty Care Models final rule and codified at § 512.360, CMS retrospectively, that is, following a MY, attributes ESRD Beneficiaries and Pre-emptive Living Donor Transplant (LDT) Beneficiaries to an ETC Participant for each month during a MY. An ESRD Beneficiary may be attributed to an ETC Participant if the beneficiary has already had a kidney transplant and has a non-AKI dialysis or MCP claim less than 12 months after the beneficiary's transplant date and has a kidney transplant failure ICD-10
We considered a proposal to modify the language at 42 CFR 512.310 that an ESRD Beneficiary is a beneficiary that has already received a kidney transplant and has a non-AKI or MCP dialysis claim less than 12 months after the beneficiary's latest transplant date with kidney transplant failure diagnosis code documented on any Medicare claim. We considered removing the last clause; in other words, removing the specification that that the beneficiary must have a kidney transplant failure diagnosis code documented on any Medicare claim. We are not proposing this modification to the definition of an ESRD Beneficiary because doing so would preclude the possibility for a beneficiary to be attributed to the ETC Model for 12-months after a transplant, regardless of if the transplant failed. We are concerned that this scenario would reduce the number of attributed beneficiary-months that would be available for us to use to calculate the home dialysis and transplant rate for ETC Participants. We are soliciting comment on our proposal to modify the definition of an ESRD Beneficiary to more accurately identify beneficiaries that may be attributed to the ETC Model due to receiving a kidney transplant that fails within 12-months of its receipt.
In the Specialty Care Models final rule, we referenced a report from the Public Policy/Advocacy Committee of the North American Chapter of the International Society for Peritoneal Dialysis that describes barriers to increased adoption of home dialysis including educational barriers, the need for home care partner support, the monthly visit requirement for the Monthly Capitation Payment (MCP) under the Physician Fee Schedule, variations in dialysis business practices in staffing allocation, lack of home clinic independence, and other restrictions resulting in the inefficient distribution of home dialysis supplies (85 FR 61265).
Since the Specialty Care Models final rule was published, interested parties have spoken to us about challenges associated with increasing access to home dialysis, particularly among beneficiaries with lower socioeconomic status, who have lower rates of home dialysis and kidney transplantation than people with higher socioeconomic status. The ETC Model was designed to address these barriers; for example, CMS applied the Home Dialysis Payment Adjustment (HDPA) to assist dialysis organizations with overcoming market realities that impose substantial barriers to opening and sustaining home dialysis programs. The upside and downside risk associated with the Performance Payment Adjustment (PPA) are designed to be strong incentives for behavioral change towards increasing beneficiary access to home dialysis. In the CY 2022 ESRD PPS final rule, we finalized a policy whereby we stratify achievement benchmarks based on the proportion of attributed beneficiaries who are dual eligible for both Medicare and Medicaid or who receive the Low-Income Subsidy (LIS) (86 FR 61968). We also finalized the Health Equity Incentive (HEI), which rewards ETC Participant aggregation groups that demonstrate greater than 2.5 percentage points improvement on the home dialysis and transplant rate among dual eligible and LIS recipient beneficiaries from the Benchmark Year (BY) to the MY with a .5 increase in their improvement score (86 FR 61971).
Performance accountability in the ETC Model is scheduled to end on June 30, 2026. We are concerned that the end of performance accountability may reduce incentives for dialysis organizations to invest in access to home dialysis and address the challenges of the type we describe previously in this section. We are interested in hearing from interested parties regarding policies that the Innovation Center may consider specifically incorporating into any successor model to the ETC Model or that CMS may consider generally. Given the growth in ESRD beneficiaries choosing Medicare Advantage plans,
We are soliciting input on the following topics that may improve our understanding of other policy interventions that may increase access to high quality home dialysis within the context of Innovation Center models and across CMS.
1. How should any future Innovation Center model that incorporates home dialysis incorporate what the community has learned from the ETC Model?
2. What barriers to home dialysis could be addressed through the ESRD Prospective Payment System (PPS)? We request that commenters be as specific as possible.
3. What approaches could CMS consider to increase beneficiary access to home dialysis modalities in Medicare Advantage?
4. How should nephrologist payment from traditional, fee-for-service Medicare and from MAOs account for clinician-level barriers to prescribing and retaining patients on home modalities?
Please note, this is a RFI only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the
Respondents are encouraged to provide complete but concise responses. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. This RFI does not commit the United States Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through this RFI and will not accept unsolicited proposals. Responders are advised that the United States Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Not responding to this RFI does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this RFI announcement for additional information pertaining to this request. Please note that we will not respond to questions about the policy issues raised in this RFI. We may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review RFI responses. Responses to this notice are not offers and cannot be accepted by the United States Government to form a binding contract or issue a grant. Information obtained as a result of this RFI may be used by the United States Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This RFI should not be construed as a commitment or authorization to incur cost for which reimbursement would be required or sought. All submissions become United States Government property and will not be returned. We may publicly post the comments received, or a summary thereof.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
We refer readers to the CY 2024 ESRD PPS final rule for information regarding wage estimates and resulting information collection burden calculations used in this proposed rule (88 FR 76484 through 76485). To derive wage estimates, we used data from the United States Bureau of Labor Statistics' May 2022 National Occupational Employment and Wage Estimates for Medical Records Specialists, who are responsible for organizing and managing health information data, are the individuals tasked with submitting measure data to the ESRD Quality Reporting System (EQRS) (formerly, CROWNWeb) and the Centers for Disease Control and Prevention's (CDC's) NHSN, as well as compiling and submitting patient records for the purpose of data validation. When this analysis was conducted, the most recently available median hourly wage of a Medical Records Specialist was $22.69 per hour.
We used this wage estimate, along with updated facility and patient counts, to estimate the total information collection burden in the ESRD QIP for PY 2027 in the CY 2024 ESRD PPS final rule (88 FR 76485 through 76486). We will update the information collection burden to reflect updated wage estimates, along with updated facility and patient counts, in the CY 2025 ESRD PPS final rule.
We refer readers to the CY 2024 ESRD PPS final rule for information regarding the estimated burden associated with
To estimate the burden associated with the EQRS reporting requirements (previously known as the CROWNWeb reporting requirements), we look at the total number of patients nationally, the number of data elements per patient-year that the facility would be required to submit to EQRS for each measure, the amount of time required for data entry, the estimated wage plus benefits applicable to the individuals within facilities who are most likely to be entering data into EQRS, and the number of facilities submitting data to EQRS. In the CY 2024 ESRD PPS final rule, we estimated that the burden associated with EQRS reporting requirements for the PY 2027 ESRD QIP was approximately $130.5 million for approximately 2,877,743 total burden hours (88 FR 76486).
We are proposing changes to the ESRD QIP measure set in this proposed rule, but do not anticipate that any of these proposals would affect the burden we have previously estimated for EQRS reporting requirements for PY 2027. Beginning with PY 2027, we are proposing to replace the Kt/V Dialysis Adequacy Comprehensive measure with a Kt/V Dialysis Adequacy Measure Topic. However, we are not proposing to update facility reporting requirements as part of that proposal. Additionally, although we are proposing to remove one measure from the ESRD QIP measure set beginning with PY 2027, the proposed measure removal would not impact EQRS reporting requirements on facilities. We provided the burden estimate for PY 2027 in the CY 2024 ESRD PPS final rule (88 FR 76486), and will update the information collection burden to reflect updated wage estimates, along with updated facility and patient counts, in the CY 2025 ESRD PPS final rule. In the CY 2024 ESRD PPS final rule, we estimated that the amount of time required to submit measure data to EQRS would be 2.5 minutes per element and did not use a rounded estimate of the time needed to complete data entry for EQRS reporting. There are 136 data elements for 507,837 patients across 7,833 facilities, for a total of 69,065,832 elements (136 data elements × 507,837 patients). At 2.5 minutes per element, this would yield approximately 367.3 hours per facility. Therefore, the PY 2027 burden would be 2,877,743 hours (367.3 hours × 7,833 facilities). Using the Medical Records Specialist wage estimate available at that time, we estimated that the PY 2027 total burden cost would be approximately $130.5 million (2,877,743 hours × $45.38). We intend to re-calculate the burden estimate for PY 2027, using updated estimates of the total number of ESRD facilities, the total number of patients nationally, and wages for Medical Records Specialists or similar staff, as well as a refined estimate of the number of hours needed to complete data entry for EQRS reporting in the CY 2025 ESRD PPS final rule. The information collection request under the OMB Control Number: 0938-1289 will be revised and sent to OMB.
Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the ETC Model, from the provisions of the PRA. Specifically, this section provides that the provisions of the PRA do not apply to the testing and evaluation of Innovation Center models or to the expansion of such models.
If you comment on these information collections, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments electronically as specified in the
Comments must be received on/by August 26, 2024.
Because of the large number of public comments we normally receive on
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Act, as added by section 153(b) of MIPPA (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Affordable Care Act (Pub. L. 111-148), established that beginning CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This proposed rule includes proposed updates and policy changes to the ESRD PPS for CY 2025. These changes include a proposed new wage index methodology which utilizes BLS data, a proposed wage index budget-neutrality adjustment factor, a proposed expansion to the ESRD PPS outlier list, proposed methodological changes to the outlier calculation, proposed updates to the TPNIES offset amount, proposed updates to the post-TDAPA add-on payment adjustment amounts for Korsuva® and Jesduvroq, and proposed changes to the LVPA payment structure. Failure to publish this proposed rule would result in ESRD facilities not receiving appropriate payments in CY 2025 for renal dialysis services furnished to ESRD beneficiaries.
This proposed rule also has several proposed policy changes to improve payment stability and adequacy under the ESRD PPS. These include updates to the LVPA and payments for ESRD outlier services. We believe that each of these proposed changes would improve payment stability and adequacy under the ESRD PPS.
This rule proposes updates to the payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI. Additionally, we are proposing to extend Medicare payment for home dialysis to beneficiaries with AKI. As discussed in section III.C of this proposed rule, we are also proposing to apply the updates to the ESRD PPS base rate and wage index to the AKI dialysis payment rate. Failure to publish this proposed rule would result in ESRD facilities not receiving appropriate payments in CY 2025 for renal dialysis services furnished to patients with AKI in accordance with section 1834(r) of the Act.
Section 1881(h)(1) of the Act requires CMS to reduce the payments otherwise made to a facility under the ESRD PPS by up to two percent if the facility does not satisfy the requirements of the ESRD QIP for that year. This rule proposes updates for the ESRD QIP, which would remove the NHSN Dialysis Event reporting measure from the ESRD QIP measure set beginning with PY 2027 and replace the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic beginning with PY 2027.
The ETC Model is a mandatory Medicare payment model tested under the authority of section 1115A of the Act, which authorizes the Innovation Center to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and CHIP expenditures while preserving or enhancing the quality of care furnished to the beneficiaries of such programs.
This proposed rule proposes a change to the ETC Model, specifically to the methodology CMS uses to identify transplant failures for the purposes of defining an ESRD beneficiary and attributing an ESRD beneficiary to the ETC Model. As described in detail in section V.B of this proposed rule, we believe it is necessary, for the purposes of accuracy, to adopt this change to the ETC Model.
We have examined the impacts of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094, entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 14094 amends section 3(f) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more in any 1 year, (adjusted every 3 years by the Administrator of OMB's Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product) 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, territorial, or Tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in this Executive order.
A regulatory impact analysis (RIA) must be prepared for a regulatory action that is significant under section 3(f)(1). Based on our estimates of the combined impact of the ESRD PPS, ESRD QIP, and ETC provisions in this proposed rule, OIRA has determined this rulemaking is significant per section 3(f)(1). Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act), OIRA has also determined that this proposed rule meets the criteria set forth in 5 U.S.C. 804(2). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking. Therefore, OMB has reviewed these proposed regulations, and the Department has provided the following assessment of their impact.
We estimate that the proposed revisions to the ESRD PPS would result in an increase of approximately $170 million in Medicare payments to ESRD facilities in CY 2025, which includes the amount associated with updates to the outlier list, updates to the outlier methodology and thresholds, payment rate update, updates to the wage index methodology, updates to the OMB CBSA delineations, proposed changes to the LVPA, the updated post-TDAPA add-on payment adjustment amounts, and continuation of the approved TDAPA as identified in table 18. Although the incorporation of oral-only renal dialysis drugs and biological products into the ESRD PPS in CY 2025 is provided for by existing regulations and is not impacted by this proposed rule, we estimate for reference that total ESRD PPS spending for phosphate binders will be approximately $870 million in CY 2025 ($220 million in beneficiary coinsurance payments and $650 million in Medicare Part B spending); however we note that these drugs are currently being paid for under Medicare Part D, which we estimate will lead to a decrease in spending of approximately $690 million ($90 million in beneficiary premium offset and $600 million in Medicare Part D spending), for a net payment increase of $180 million.
We estimate that the proposed updates to the AKI payment rate would result in an increase of approximately $1 million in Medicare payments to ESRD facilities in CY 2025.
We estimate that, as a result of our previously finalized policies and the policies we are proposing in this proposed rule, the updated ESRD QIP will result in $14.6 million in estimated payment reductions across all facilities for PY 2027.
The change we are proposing to the definition of an ESRD Beneficiary for the purposes of attribution in the ETC Model is not expected to change the model's projected economic impact.
We estimate that the combined impact of the policies proposed in this rule on payments for CY 2025 is $170 million based on the estimates of the updated ESRD PPS and the AKI payment rates. We estimate the impacts of the ESRD
In this section, we discuss the anticipated benefits, costs, and transfers associated with the changes in this proposed rule. Additionally, we estimate the total regulatory review costs associated with reading and interpreting this proposed rule.
Under the CY 2025 ESRD PPS and AKI payment, ESRD facilities would continue to receive payment for renal dialysis services furnished to Medicare beneficiaries under a case-mix adjusted PPS. We continue to expect that making prospective Medicare payments to ESRD facilities would enhance the efficiency of the Medicare program. Additionally, we expect that updating the Medicare ESRD PPS base rate and rate for AKI treatments furnished by ESRD facilities by 1.8 percent based on the proposed CY 2025 ESRDB market basket percentage increase of 2.3 percent reduced by the proposed CY 2025 productivity adjustment of 0.5 percentage point would improve or maintain beneficiary access to high quality care by ensuring that payment rates reflect the best available data on the resources involved in delivering renal dialysis services. We estimate that overall payments under the ESRD PPS would increase by 2.2 percent as a result of the proposed policies in this rule.
We do not anticipate the provisions of this proposed rule regarding ESRD PPS and AKI rates-setting would create additional cost or burden to ESRD facilities.
We have made no changes to our methodology for calculating the annual burden associated with the information collection requirements for EQRS data validation (previously known as the CROWNWeb validation study) or NHSN data validation. Although we do not anticipate that the proposals in this proposed rule regarding ESRD QIP will create additional cost or burden to ESRD facilities for PY 2027, in the CY 2025 ESRD PPS final rule, we intend to update the estimated costs associated with the information collection requirements under the ESRD QIP, with updated estimates of the total number of ESRD facilities, the total number of patients nationally, wages for Medical Records Specialists or similar staff, and a refined estimate of the number of hours needed to complete data entry for EQRS reporting.
We estimate that the updates to the ESRD PPS and AKI payment rates would result in a total increase of approximately $170 million in Medicare payments to ESRD facilities in CY 2025, which includes the amount associated with proposed updates to the outlier thresholds, and proposed updates to the wage index. This estimate includes an increase of approximately $1 million in Medicare payments to ESRD facilities in CY 2025 due to the updates to the AKI payment rate, of which approximately 20 percent is increased beneficiary coinsurance payments. We estimate approximately $140 million in transfers from the Federal Government to ESRD facilities due to increased Medicare program payments and approximately $30 million in transfers from beneficiaries to ESRD facilities due to increased beneficiary coinsurance payments because of this proposed rule.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this ESRD PPS proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the ESRD PPS proposed rule, we assume that the total number of unique commenters on last year's ESRD PPS proposed rule, which was 256 for the CY 2024 ESRD PPS proposed rule, is equal to the number of individual reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the CY 2024 ESRD PPS proposed rule. For these reasons we determined that the number of past commenters would be a fair estimate of the number of reviewers of this proposed rule. We welcome any comments on the approach in estimating the number of entities which will review this proposed rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of this proposal. We seek comments on this assumption.
Using the May 2023 wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $129.28 per hour, including overhead and fringe benefits
To understand the impact of the changes affecting Medicare payments to different categories of ESRD facilities, it is necessary to compare estimated payments in CY 2024 to estimated payments in CY 2025. To estimate the impact among various types of ESRD facilities, it is imperative that the estimates of Medicare payments in CY 2024 and CY 2025 contain similar inputs. Therefore, we simulated Medicare payments only for those ESRD facilities for which we can calculate both current Medicare payments and new Medicare payments.
For this proposed rule, we used CY 2023 data from the Medicare Part A and Part B Common Working Files as of February 16, 2024, as a basis for Medicare dialysis treatments and payments under the ESRD PPS. We updated the 2023 claims to 2024 and 2025 using various updates. The proposed updates to the ESRD PPS base rate are described in section II.B.4 of this proposed rule. Table 18 shows the impact of the estimated CY 2025 ESRD
Column A of the impact table indicates the number of ESRD facilities for each impact category and column B indicates the number of dialysis treatments (in millions). The overall effect of the proposed routine updates to the outlier payment policy, including proposed changes to the inflation factors used for calculating MAP and FDL amounts described in section II.B.3 of this proposed rule, is shown in column C. For CY 2025, the impact on all ESRD facilities because of the proposed changes to the outlier payment policy would be an increase in estimated Medicare payments of approximately 0.4 percent.
Column D shows the effect of the proposed 2-tiered LVPA as described in section II.B.8 of this proposed rule. This adjustment is implemented in a budget neutral manner, so the total impact of this proposed change would be 0.0 percent. However, there would be distributional impacts of this change, if finalized, primarily increasing payments to facilities that furnish fewer than 3000 treatments by 0.8 percent and lowering payments to ESRD facilities that furnish between 3000 and 4000 treatments by 0.7 percent. Because we are proposing to use the scaled adjustment factors, the only impact of this proposed policy is among ESRD facilities that are eligible for the LVPA.
Column E shows the effect of year-over-year payment changes related to the proposed post-TDAPA add-on payment adjustment amounts as described in section II.B.6 of this proposed rule and current TDAPA payments. The post-TDAPA add-on payment adjustment will not be budget neutral, but the total impact on payment is 0.1 percent due to relatively low utilization of drugs for which we will pay this adjustment in CY 2025.
Column F reflects the impact of the proposed expansion of outlier eligibility to formerly composite rate drugs. Overall the proposed changes to the outlier policy, including those reflected in column C of this table, are budget neutral insofar as we estimate that we would better hit the 1 percent target for outlier payments. These proposed changes would increase payments for facilities that treat a higher proportion of exceptionally costly cases.
Column G reflects the effect of the proposed changes to the ESRD PPS wage index methodology, the proposed adoption of the new OMB CBSA delineations, the continued application of the 5 percent cap on wage index decreases, and the proposed rural transition policy as described in section II.B.2 of this proposed rule. This proposed update would be budget neutral, so the total impact of this proposed policy change is 0.0 percent. However, there would be distributional impacts of this proposed change, if finalized. The largest increase would be to ESRD facilities in Puerto Rico and the Virgin Islands, which would receive 3.1 percent higher payments because of the
Column H reflects the overall impact, that is, the effects of the proposed outlier policy changes, proposed LVPA changes, the proposed post-TDAPA add-on payment adjustment amounts, the proposed new wage index methodology, the proposed new CBSA delineations, the proposed rural transition policy, and the proposed payment rate update as described in section II.B.4 of this proposed rule. The proposed ESRD PPS payment rate update for CY 2025 is 1.8 percent, which reflects the proposed ESRDB market basket percentage increase for CY 2025 of 2.3 percent and the proposed productivity adjustment of 0.5 percent. We expect that overall ESRD facilities would experience a 2.2 percent increase in estimated Medicare payments in CY 2025. The categories of types of ESRD facilities in the impact table show impacts ranging from a 0.0 percent increase to a 5.2 percent increase in their CY 2025 estimated Medicare payments.
This table does not include the impact of the inclusion of oral-only drugs to the ESRD PPS as we are unable to calculate facility level estimates at this time. Furthermore, we note that the incorporation of oral-only renal dialysis drugs and biological products into the ESRD PPS in CY 2025 is provided for by existing regulations and is not impacted by this proposed rule. For public awareness, we estimate an increase in Medicare Part B spending of approximately $870 million in CY 2025, and a corresponding decrease in Medicare Part D spending of approximately $690 million in CY 2025, associated with payment for phosphate binders under the ESRD PPS.
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled payment for renal dialysis services, which may have been separately paid to other providers (for example, laboratories, durable medical equipment suppliers, and pharmacies) by Medicare prior to the implementation of the ESRD PPS. Therefore, in CY 2025, we estimate that the ESRD PPS would have zero impact on these other providers.
We estimate that Medicare spending (total Medicare program payments) for ESRD facilities in CY 2025 would be approximately $7.2 billion. This estimate considers a projected decrease in fee-for-service Medicare ESRD beneficiary enrollment of 2.1 percent in CY 2025.
Under the ESRD PPS, beneficiaries are responsible for paying 20 percent of the ESRD PPS payment amount. As a result of the projected 2.2 percent overall increase in the CY 2025 ESRD PPS payment amounts, we estimate that there would be an increase in beneficiary coinsurance payments of 2.2 percent in CY 2025, which translates to approximately $30 million.
As we have previously noted, the incorporation of oral-only renal dialysis drugs and biological products into the ESRD PPS in CY 2025 is provided for by existing regulations and is not impacted by this proposed rule. For public awareness, we estimate an increase in beneficiary coinsurance payments of $220 million. As noted in section II.B.7 of this proposed rule, we anticipate that the inclusion of oral-only drugs in the ESRD PPS will increase access to these drugs for beneficiaries, particularly disadvantaged populations who currently do not have Part D coverage.
We considered several alternatives for the proposed new wage index methodology discussed in section II.B.2 of this proposed rule. We considered both alternatives for the data sources we propose to use for the new wage index methodology and construction of the wage index itself. These alternatives include using confidential BLS data instead of the publicly available data, using different occupation codes for the occupations included in the analysis than those chosen, the use of state-level or regional occupational mixes instead of a single national occupational mix, an alternative or additional phase-in policy for the wage index methodology change, setting the NEFOM annually through rulemaking instead of as a part of the wage index methodology, and the use of a summary statistic other than mean hourly wage for the BLS OEWS data (such as the median). These alternatives and the reasons we did not propose them are discussed in further detail in section II.B.2.b.(c) of this proposed rule.
We considered only expanding outlier eligibility to drugs and biological products previously paid for under the TDAPA after the end of the TDAPA period. As discussed in section II.B.3.b of this proposed rule, we have instead decided to propose to expand outlier eligibility to all drugs and biological products that were or would have been composite rate services prior to the inception of the ESRD PPS.
We considered, but did not propose, paying the TDAPA for phosphate binders based on an amount greater than 100 percent of ASP, to account for additional costs such as dispensing fees. For example, we considered paying the TDAPA for phosphate binders at 106 percent of ASP for at least 2 years to mirror our TDAPA payment approach for the first 2 years for calcimimetics. However, as discussed in section II.B.7.c of this proposed rule, we believe that it is most appropriate to use the current standard TDAPA payment amount of 100 percent of ASP for phosphate binders. We are soliciting comments on this policy and may consider finalizing changes in the final rule.
We considered, but did not propose, expanding LVPA eligibility to ESRD facilities which furnished more than 4000 treatments in one of the past 3 years whose median treatment volume over the past 3 years was less than 4000. However, we felt that this would be inappropriate as the purpose of this proposed change is to better allocate payments within the LVPA, not to expand the LVPA. Additionally, using the median tier methodology for LVPA eligibility would reduce the LVPA payments for ESRD facilities that would qualify under the current methodology by a notable amount due to the lower scaling factor. As discussed in section II.B.8.c of this proposed rule, we are not proposing any changes to the LVPA eligibility requirements at 42 CFR 413.232(b).
Two renal dialysis drugs for which the TDAPA was paid in CY 2024 would continue to be eligible for the TDAPA in CY 2025.
On July 27, 2023, CMS Transmittal 12157
We based our impact analysis on the most current 72x claims data from November 2023, when utilization first appeared on the claims, through February 2024. During that timeframe, the average monthly TDAPA payment amount for Jesduvroq (daprodustat) was $23,075. In applying that average to each of the 9 remaining months of the TDAPA payment period in CY 2025, we estimate $207,675 in spending ($23,075 * 9 = $207,675) of which, approximately $41,535 ($207,675 * 0.20 = $41,535) would be attributed to beneficiary coinsurance amounts.
On May 9, 2024, CMS Transmittal 12628
We have not included Medicare impact estimates in this proposed rule but intend to update the impact estimates to include DefenCath in the CY 2025 ESRD PPS final rule.
To understand the impact of the proposed changes affecting Medicare payments to different categories of ESRD facilities for renal dialysis services furnished to individuals with AKI, it is necessary to compare estimated Medicare payments in CY 2024 to estimated Medicare payments in CY 2025. To estimate the impact among various types of ESRD facilities for renal dialysis services furnished to individuals with AKI, it is imperative that the Medicare payment estimates in CY 2024 and CY 2025 contain similar inputs. Therefore, we simulated Medicare payments only for those ESRD facilities for which we can calculate both current Medicare payments and new Medicare payments.
For this proposed rule, we used CY 2023 data from the Medicare Part A and Part B Common Working Files as of February 16, 2024, as a basis for Medicare for renal dialysis services furnished to individuals with AKI. We updated the 2023 claims to 2024 and 2025 using various updates. The updates to the AKI payment amount are described in section III.C of this proposed rule. Table 19 shows the impact of the estimated CY 2025 Medicare payments for renal dialysis services furnished to individuals with AKI compared to estimated Medicare payments for renal dialysis services furnished to individuals with AKI in CY 2024.
Column A of the impact table indicates the number of ESRD facilities for each impact category, and column B indicates the number of AKI dialysis treatments (in thousands). Column C shows the effect of the proposed CY 2025 wage index changes, including the proposed changes to the ESRD PPS wage index methodology, the proposed adoption of the new OMB CBSA delineations, the continued application of the 5 percent cap on wage index decreases, and the proposed rural transition policy as described in section II.B.2.f.(2) of this proposed rule.
Column D shows the overall impact, that is, the effects of the proposed wage index budget-neutrality adjustment factor, wage index updates, and the payment rate update of 1.8 percent, which reflects the proposed ESRDB market basket percentage increase for CY 2025 of 2.3 percent and the proposed productivity adjustment of 0.5 percentage point. We expect that overall ESRD facilities will experience a 1.9 percent increase in estimated Medicare payments in CY 2025 for treatment of AKI patients. This table does not include any distributional impacts of payments to ESRD facilities associated with the extension of payment for AKI home dialysis or extension of the add-on payment adjustment for training for home and self-dialysis, as we are unable to estimate potential uptake at a facility level at this time. However, we note that because the implementation of that adjustment would be required by section 1834(r)(1) of the Act to be budget neutral, we are considering whether it would be appropriate to apply a reduction to the AKI dialysis payment rate for budget neutrality, which could result in distributional payment changes in the future. The categories of types of ESRD facilities in the impact table show impacts ranging from an increase of 0.0 percent to an increase of 3.7 percent in their CY 2025 estimated Medicare payments for renal dialysis services provided by ESRD facilities to individuals with AKI.
Under section 1834(r) of the Act, as added by section 808(b) of TPEA, we are proposing to update the payment rate for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. The only two Medicare providers and suppliers authorized to provide these outpatient renal dialysis services are hospital outpatient departments and ESRD facilities. The patient and his or her physician make the decision about where the renal dialysis services are furnished. Therefore, this change would have zero impact on other Medicare providers.
We estimate approximately $70 million would be paid to ESRD facilities in CY 2025 because of patients with AKI receiving renal dialysis services in an ESRD facility at the lower ESRD PPS base rate versus receiving those services only in the hospital outpatient setting and paid under the outpatient prospective payment system, where services were required to be administered prior to the TPEA.
Currently, beneficiaries have a 20 percent coinsurance obligation when they receive AKI dialysis in the hospital outpatient setting. When these services are furnished in an ESRD facility, the patients will continue to be responsible for a 20 percent coinsurance. Because the AKI dialysis payment rate paid to ESRD facilities is lower than the outpatient hospital PPS's payment
As we discussed in the CY 2017 ESRD PPS proposed rule (81 FR 42870), we considered adjusting the AKI payment rate by including the ESRD PPS case-mix adjustments, and other adjustments at section 1881(b)(14)(D) of the Act, as well as not paying separately for AKI specific drugs and laboratory tests. We ultimately determined that treatment for AKI is substantially different from treatment for ESRD, and the case-mix adjustments applied to ESRD patients may not be applicable to AKI patients, and as such, including those policies and adjustments is inappropriate. We continue to monitor utilization and trends of items and services furnished to individuals with AKI for purposes of refining the payment rate in the future. This monitoring will assist us in developing knowledgeable, data-driven proposals.
As discussed in section III.B of this proposed rule, we are proposing to allow for payment for AKI dialysis in the home setting, and as discussed in section III.C.3 of this proposed rule we are proposing to apply the home and self-dialysis training add-on payment adjustment for such services provided to AKI patients. We considered proposing to pay for AKI home dialysis without the training add-on adjustment; however, we are concerned that access to home dialysis for AKI beneficiaries could be negatively impacted in the absence of an add-on payment adjustment to support home dialysis training.
The ESRD QIP is intended to promote improvements in the quality of ESRD dialysis facility services provided to beneficiaries. The general methodology that we use to calculate a facility's TPS is described in our regulations at § 413.178(e).
Any reductions in the ESRD PPS payments as a result of a facility's performance under the PY 2027 ESRD QIP will apply to the ESRD PPS payments made to the facility for services furnished in CY 2027, consistent with our regulations at § 413.177.
For the PY 2027 ESRD QIP, we estimate that, of the 7,833 facilities (including those not receiving a TPS) enrolled in Medicare, approximately 28.3 percent or 2,214 of the facilities that have sufficient data to calculate a TPS would receive a payment reduction for PY 2027. Among an estimated 2,214 facilities that would receive a payment reduction, approximately 65 percent or 1,443 facilities would receive the smallest payment reduction of 0.5 percent. We are updating the estimated impact of the PY 2027 ESRD QIP that we provided in the CY 2024 ESRD PPS final rule (88 FR 76495 through 76497). Based on our proposals, the total estimated payment reductions for all the 2,214 facilities expected to receive a payment reduction in PY 2027 would be approximately $14,647,335. Facilities that do not receive a TPS do not receive a payment reduction.
Table 20 shows the updated overall estimated distribution of payment reductions resulting from the PY 2027 ESRD QIP.
To estimate whether a facility would receive a payment reduction for PY 2027, we scored each facility on achievement and improvement on several clinical measures for which there were available data from EQRS and Medicare claims. Payment reduction estimates were calculated using the most recent data available (specified in table 21) in accordance with the policies proposed in this proposed rule. Measures used for the simulation are shown in table 21.
For all measures except the SHR clinical measure, the SRR clinical measure, and the STrR measure, measures with less than 11 patients for a facility were not included in that facility's TPS. For the SHR clinical measure and the SRR clinical measure, facilities were required to have at least 5 patient-years at risk and 11 index discharges, respectively, to be included in the facility's TPS. For the STrR clinical measure, facilities were required to have at least 10 patient-years at risk to be included in the facility's TPS. Each facility's TPS was compared to an estimated mTPS and an estimated payment reduction table consistent with the proposed policies outlined in section IV.B of this proposed rule. Facility reporting measure scores were estimated using available data from CY 2022. Facilities were required to have at least one measure in at least two domains to receive a TPS.
To estimate the total payment reductions in PY 2027 for each facility resulting from this proposed rule, we multiplied the total Medicare payments to the facility during the 1-year period between January 2022 and December 2022 by the facility's estimated payment reduction percentage expected under the ESRD QIP, yielding a total payment reduction amount for each facility.
Table 22 shows the estimated impact of the ESRD QIP payment reductions to all ESRD facilities for PY 2027. The table also details the distribution of ESRD facilities by size (both among facilities considered to be small entities and by number of treatments per facility), geography (both rural and urban and by region), and facility type (hospital based and freestanding facilities). Given that the performance period used for these calculations differs from the performance period we are using for the PY 2027 ESRD QIP, the actual impact of the PY 2027 ESRD QIP may vary significantly from the values provided here.
For PY 2027, we estimate that the ESRD QIP would contribute approximately $14,647,335 in Medicare savings. For comparison, table 23 shows the payment reductions that we estimate will be applied by the ESRD QIP from PY 2018 through PY 2027.
The ESRD QIP is applicable to ESRD facilities. Since the Program's inception, there is evidence of improved performance on ESRD QIP measures. As we stated in the CY 2018 ESRD PPS final rule, one objective measure we can examine to demonstrate the improved quality of care over time is the improvement of performance standards (82 FR 50795). As the ESRD QIP has refined its measure set and as facilities have gained experience with the measures included in the Program, performance standards have generally continued to rise. We view this as evidence that facility performance (and therefore the quality of care provided to Medicare beneficiaries) is objectively improving. We continue to monitor and evaluate trends in the quality and cost of care for patients under the ESRD QIP, incorporating both existing measures and new measures as they are implemented in the Program. We will provide additional information about the impact of the ESRD QIP on beneficiaries as we learn more by examining these impacts through the analysis of available data from our existing measures.
In section IV.B.2 of this proposed rule, we are proposing to replace the Kt/V Dialysis Adequacy Comprehensive clinical measure with a Kt/V Dialysis Adequacy Measure Topic beginning with PY 2027. We considered not proposing this change. However, we concluded that replacing this measure was appropriate to ensure that facilities are scored on Kt/V measure data according to the individual facility's ESRD patient population and treatment modalities.
The ETC Model is a mandatory payment model designed to test payment adjustments to certain dialysis and dialysis-related payments, as discussed in the Specialty Care Models final rule (85 FR 61114), the CY 2022 ESRD PPS final rule (86 FR 61874), the CY 2023 ESRD PPS final rule (87 FR 67136), and the CY 2024 ESRD PPS final rule (88 FR 76344) for ESRD facilities and for Managing Clinicians for claims with dates of service from January 1, 2021, to June 30, 2027. The requirements for the ETC Model are set forth in 42 CFR part 512, subpart C. For the results of the detailed economic analysis of the ETC Model and a description of the methodology used to perform the analysis, see the Specialty Care Models final rule (85 FR 61114).
A stochastic simulation was created to estimate the financial impacts of the ETC Model relative to baseline expenditures, where baseline expenditures were defined as data from CYs 2018 and 2019 without the changes applied. The simulation relied upon statistical assumptions derived from retrospectively constructed ESRD facilities' and Managing Clinicians' Medicare dialysis claims, transplant claims, and transplant waitlist data reported during 2018 and 2019, the most recent years of complete data available before the start of the ETC Model. Both datasets and the risk-adjustment methodologies for the ETC Model were developed by the CMS Office of the Actuary (OACT).
Table 24 summarizes the estimated impact of the ETC Model when the achievement benchmarks for each year are set using the average of the home dialysis rates for year
In table 24, negative spending reflects a reduction in Medicare spending, while positive spending reflects an increase. The results for this table were generated from an average of 400 simulations under the assumption that benchmarks are rolled forward with a 1.5-year lag. For a detailed description of the key assumptions underlying the impact estimate, see the Specialty Care Models final rule (85 FR 61353) and the CY 2022 ESRD PPS final rule (86 FR 60214 through 60216).
The change proposed in this rule is not expected to impact the findings reported for the effects of the ETC Model on the home dialysis rate or the transplant rate described in the Specialty Care Models final rule (85 FR 61355) and the CY 2022 ESRD PPS final rule (86 FR 62017).
The change proposed in this rule is not expected to impact the findings reported for the effects of the ETC Model on kidney disease patient education services and HD training add-ons described in the Specialty Care Models final rule (85 FR 61355) and the CY 2022 ESRD PPS final rule (86 FR 62017).
Our proposal to revise the definition of an ESRD Beneficiary for the purposes of attribution is not expected to impact the findings reported for the effects of ETC Model on Medicare beneficiaries. Further details on the impact of the ETC Model on ESRD Beneficiaries may be found in the Specialty Care Models final rule (85 FR 61357) and the CY 2022 ESRD PPS final rule (86 FR 61874).
Throughout this proposed rule, we have identified our policy proposal and alternatives considered, and provided information as to the likely effects of these alternatives and rationale for our proposal.
The Specialty Care Models final rule (85 FR 61114), the CY 2022 ESRD PPS final rule (86 FR 61874), the CY 2023 ESRD PPS final rule (87 FR 67136), the CY 2024 ESRD PPS final rule (88 FR 76344), and the proposals herein address a model specific to ESRD. These rules provide descriptions of the requirements that we waive, identify the performance metrics and payment adjustments to be tested, and presents rationales for our changes, and where relevant, alternatives considered. For context related to alternatives previously considered when establishing and modifying the ETC Model we refer readers to section V.B. and to the above citations.
As required by OMB Circular A-4 (available at
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. We do not believe ESRD facilities are operated by small government entities such as counties or towns with populations of 50,000 or less, and therefore, they are not enumerated or included in this estimated RFA analysis. Individuals and states are not included in the definition of a small entity. Therefore, the number of small entities estimated in this RFA analysis includes the number of ESRD facilities that are either considered small businesses or nonprofit organizations.
According to the Small Business Administration's (SBA) size standards, an ESRD facility is classified as a small business if it has total revenues of less than $47 million in any 1 year.
Additionally, we identified in our analytic file that there are 779 ESRD facilities that are considered nonprofit organizations, which is approximately 10 percent of all ESRD facilities in our data set. In total, accounting for the 360 nonprofit ESRD facilities that are also considered small businesses, there are 1,227 ESRD facilities that are either small businesses or nonprofit organizations, which is approximately 16 percent of all ESRD facilities in our data set.
As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. As shown in table 18, we estimate that the overall revenue impact of this proposed rule on all ESRD facilities is a positive increase to Medicare FFS payments by approximately 2.2 percent. For the ESRD PPS updates in this proposed rule, a hospital-based ESRD facility (as defined by type of ownership, not by type of ESRD facility) is estimated to receive a 3.9 percent increase in Medicare FFS payments for CY 2025. An independent facility (as defined by ownership type) is likewise estimated to receive a 0.5 percent increase in Medicare FFS payments for CY 2025. Among hospital-based and independent ESRD facilities, those furnishing fewer than 3,000 treatments per year are estimated to receive a 4.5 percent increase in Medicare FFS payments, and those furnishing 3,000 or more treatments per year are estimated to receive a 1.6 percent increase in Medicare FFS payments. Among nonprofit ESRD facilities, those furnishing fewer than 3,000 treatments per year are estimated to receive a 5.8 percent increase in Medicare FFS payments, and those furnishing 3,000 or more treatments per year are estimated to receive a 2.3 percent increase in Medicare FFS payments.
For AKI dialysis, we are unable to estimate whether patients would go to ESRD facilities, however, we have estimated there is a potential for $70 million in payment for AKI dialysis treatments that could potentially be furnished in ESRD facilities.
Based on the estimated Medicare payment impacts described previously, we do not believe that the change in revenue threshold will be reached by the policies in this proposed rule. Therefore, the Secretary has certified that this proposed rule will not have a significant economic impact on a substantial number of small entities.
For the ESRD QIP, we estimate that of the 2,214 ESRD facilities expected to receive a payment reduction as a result of their performance on the PY 2027 ESRD QIP, 409 are ESRD small entity facilities. We present these findings in table 20 (“Estimated Distribution of PY 2027 ESRD QIP Payment Reductions”) and table 22 (“Estimated Impact of ESRD QIP Payment Reductions to ESRD Facilities for PY 2027”).
For the ETC Model, we do not anticipate any impact from our proposal to modify the definition of an ESRD Beneficiary for the purposes of beneficiary attribution in the model.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2024, that threshold is approximately $183 million. We do not interpret Medicare payment rules as being unfunded mandates but simply as conditions for the receipt of payments from the Federal Government for providing services that meet Federal standards. This interpretation applies whether the facilities or providers are private, state, local, or Tribal. Therefore, this proposed rule does not mandate any requirements for State, local, or Tribal governments, or for the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of state, local, or Tribal government.
The Addenda for the annual ESRD PPS proposed and final rule will no longer appear in the
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on June 21, 2024.
Diseases, Health facilities, Health professions, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Diseases, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
Diseases, Health facilities, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health care, Health facilities, Health insurance, Intergovernmental relations, Medicare, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.
(a) Medicare Part B pays for the following services, supplies, and equipment furnished to a patient with ESRD or an individual with Acute Kidney Injury (AKI) as defined in § 413.371 of this chapter in his or her home:
42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395m, 1395x(v), 1395x(kkk), 1395hh, 1395rr, 1395tt, and 1395ww.
(d) * * *
(2) The wage index using the most current wage data for occupations related to the furnishing of renal dialysis services from the Bureau of Labor Statistics and occupational mix data from the most recent complete calendar year of Medicare cost reports submitted in accordance with § 413.198(b).
(a) CMS adjusts the labor-related portion of the base rate to account for geographic differences in the area wage levels using an appropriate wage index (established by CMS) which reflects the relative level of wages relevant to the furnishing of renal dialysis services in the geographic area in which the ESRD facility is located.
(b) * * *
(4) Has a complete Healthcare Common Procedure Coding System (HCPCS) Level II code application submitted, in accordance with the HCPCS Level II coding procedures on the CMS website, by the HCPCS Level II code application deadline for
(a) * * *
(1) * * *
(vii) Renal dialysis drugs and biological products that are Composite Rate Services as defined in § 413.171.
(a) CMS applies the wage-adjusted add-on per treatment adjustment for home and self-dialysis training as set forth at § 413.235(c) to payments for AKI dialysis claims that include such training.
(b) The payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act.
(a) The AKI dialysis payment rate applies to renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or provider of services paid under section 1881(b)(14) of the Act, including home services, supplies, and equipment, and self-dialysis.
42 U.S.C. 1302 and 1395hh.
(a) * * *
(1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with kidney failure;
(10) Be informed by the physician, nurse practitioner, clinical nurse specialist, or physician's assistant treating the patient for kidney failure of his or her own medical status as documented in the patient's medical record, unless the medical record contains a documented contraindication;
(c) * * *
(1) * * *
(i) How plans in the individual market will affect the patient's access to, and costs for the providers and suppliers, services, and prescription drugs that are currently within the individual's plan of care as well as those likely to result from other documented health care needs. This must include an overview of the health-related and financial risks and benefits of the individual market plans available to the patient (including plans offered through and outside the Exchange).
The facility's interdisciplinary team consists of, at a minimum, the patient or the patient's designee (if the patient chooses), a registered nurse, a physician treating the patient for kidney failure, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient's treatment plan and expectations for care.
(b) * * *
(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist, or physician's assistant providing dialysis care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis.
(a) * * *
(3) * * *
(i) The nature and management of their kidney failure.
A special purpose renal dialysis facility is approved to furnish dialysis on a short-term basis at special locations. Special purpose dialysis facilities are divided into two categories: vacation camps (locations that serve patients with kidney failure while the patients are in a temporary residence) and facilities established to serve patients with kidney failure under emergency circumstances.
The dialysis facility must provide, or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter.
The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of dialysis services and all other home dialysis patients
42 U.S.C. 1302, 1315a, and 1395hh.
(1) Is receiving dialysis or other services for end-stage renal disease, up to and including the month in which the beneficiary receives a kidney transplant up to and including the month in which the beneficiary receives a kidney transplant.
(2) Has already received a kidney transplant and has a non-AKI dialysis or MCP claim at least 12 months after the beneficiary's latest transplant date.
(3) Has a kidney transplant failure less than 12 months after the beneficiary's latest transplant date as identified by at least one of the following:
(i) Two or more MCP claims in the180 days following the date on which the kidney transplant was received;
(ii) 24 or more maintenance dialysis treatments at any time after 180 days following the transplant date; or,
(iii) Indication of a transplant failure after the beneficiary's date of transplant based on data from the Scientific Registry of Transplant Recipients (SRTR) database.
(4) If a beneficiary meets more than one of criteria described in paragraphs (3)(i) through (iii) of this definition, the beneficiary will be considered an ESRD beneficiary starting with the earliest month in which transplant failure was recorded.
Office of Investment Security, Department of the Treasury.
Proposed rule.
This proposed rule sets forth regulations that would implement Executive Order 14105 of August 9, 2023, “Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern,” which declares a national emergency to address the threat to the United States posed by countries of concern, which seek to develop and exploit sensitive technologies or products critical for military, intelligence, surveillance, or cyber-enabled capabilities. The proposed rule would require United States persons to provide notification to the U.S. Department of the Treasury regarding certain transactions involving persons of a country of concern who are engaged in activities involving certain national security technologies and products that may contribute to the threat to the national security of the United States; and prohibit United States persons from engaging in certain other transactions involving persons of a country of concern who are engaged in activities involving certain other national security technologies and products that pose a particularly acute national security threat to the United States. This notice of proposed rulemaking (NPRM) seeks public comment on various topics related to the implementation of Executive Order 14105. In accordance with 5 U.S.C. 553(b)(4), a summary of this rule may be found at
Written comments must be received by August 4, 2024.
Written comments on this proposed rule may be submitted through one of two methods:
•
•
The Department of the Treasury encourages comments to be submitted via
Meena R. Sharma, Director, Office of Investment Security Policy and International Relations, at U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW, Washington, DC 20220; telephone: (202) 622-3425; email:
On August 9, 2023, the President issued Executive Order 14105, “Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern” (the Outbound Order), pursuant to his authority under the Constitution and the laws of the United States, including the International Emergency Economic Powers Act (IEEPA), the National Emergencies Act, and section 301 of title 3, United States Code (U.S.C.). In the Outbound Order, the President found that the advancement by countries of concern in sensitive technologies and products critical for the military, intelligence, surveillance, or cyber-enabled capabilities of such countries constitutes a threat to the national security of the United States, which has its source in whole or substantial part outside the United States, and that certain U.S. investments risk exacerbating this threat. In response, the President declared a national emergency to deal with this threat.
The Outbound Order identifies three sectors of national security technologies and products to be covered by the program: semiconductors and microelectronics, quantum information technologies, and artificial intelligence. As described in the Outbound Order, countries of concern are exploiting or have the ability to exploit certain U.S. outbound investments, including certain intangible benefits that often accompany U.S. investments and that help companies succeed. In an Annex to the Outbound Order, the President identified one country, the People's Republic of China (PRC), along with the Special Administrative Region of Hong Kong and the Special Administrative Region of Macau, as a country of concern. The President may modify the Annex to the Outbound Order and update the list of countries of concern.
Advanced technologies and products that are increasingly developed and financed by the private sector form the basis of next-generation military, intelligence, surveillance, or cyber-enabled capabilities. As stated in the Outbound Order, advancements in sensitive technologies and products in the areas of semiconductors and microelectronics, quantum information technologies, and artificial intelligence will accelerate the development of advanced computational capabilities that will enable new applications that pose significant national security risks, such as the development of more sophisticated weapons systems, breaking of cryptographic codes, and other applications that could provide a country of concern with military advantages. The potential military, intelligence, surveillance, or cyber-enabled applications of these technologies and products pose risks to U.S. national security, particularly when developed in or by a country of concern in which the government seeks to (1) direct entities to obtain technologies to achieve national security objectives; and (2) compel entities to share or transfer these technologies to the government's military, intelligence, surveillance, or security apparatuses.
U.S. investments are often more valuable than the capital alone because they can also include the transfer of intangible benefits. Intangible benefits that often accompany U.S. investments and help companies succeed include: enhanced standing and prominence, managerial assistance, access to investment and talent networks, market access, and enhanced access to additional financing. Certain investments by United States persons into a country of concern can be
The Outbound Order has two primary components that serve distinct but related objectives with respect to the relevant technologies and products. The first component requires notification to the Secretary of the Treasury (the Secretary) regarding certain types of investments by a United States person in a covered foreign person engaged in covered activities pertaining to specified categories of technologies and products. The second component requires the Secretary to prohibit certain types of investment by a United States person in a covered foreign person engaged in covered activities pertaining to other specified categories of advanced technologies and products. Both components focus on investments that could enhance a country of concern's military, intelligence, surveillance, or cyber-enabled capabilities through the advancement of technologies and products in particularly sensitive areas.
The Outbound Order directs the Secretary, in consultation with the Secretary of Commerce and, as appropriate, the heads of other relevant agencies, to issue, subject to public notice and comment, regulations that, among other things, require
The Outbound Order instructs the Secretary to identify in such regulations categories of notifiable transactions that involve covered national security technologies and products that the Secretary, in consultation with the Secretary of Commerce and, as appropriate, the heads of other relevant agencies, determines may contribute to the threat to the national security of the United States identified in the Outbound Order. The Outbound Order also instructs the Secretary to identify categories of prohibited transactions that involve technologies and products that the Secretary, in consultation with the Secretary of Commerce and, as appropriate, the heads of other relevant agencies, determines pose a particularly acute national security threat to the United States. Consistent with the Outbound Order, the Secretary may exempt from the notification requirement or prohibition any transaction determined by the Secretary, in consultation with the heads of relevant agencies, as appropriate, to be in the national interest of the United States. Additionally, the Outbound Order requires the Secretary to investigate, in consultation with the heads of relevant agencies, as appropriate, violations of the Outbound Order or the regulations and pursue civil penalties for such violations.
Concurrent with the issuance of the Outbound Order, on August 9, 2023, the Department of the Treasury issued an Advance Notice of Proposed Rulemaking, 88 FR 54961 (August 14, 2023) (ANPRM), to provide transparency and clarity about the intended scope of the program and solicit early stakeholder participation in the rulemaking process. The ANPRM outlined key concepts under consideration and sought public comment on a range of topics related to the implementation of the Outbound Order.
The Department of the Treasury received 60 public comment letters in response to the ANRPM, many from business associations that represent a wide variety of stakeholders across industries as well as from individuals and companies in the financial services, legal, and technology sectors. These comments are available on the public rulemaking docket at
The United States has long maintained an open investment policy and supports cross-border investment where consistent with the protection of United States national security interests. As discussed in the Outbound Order, certain United States investments may accelerate the development of sensitive technologies and products in countries that develop them to counter United States and allied capabilities. The Department of the Treasury has scoped the proposed rule to focus on the types of U.S. investments that present a likelihood of conveying both capital and intangible benefits that can be exploited to accelerate the development of sensitive technologies or products critical for military, intelligence, surveillance, or cyber-enabled capabilities of such countries in ways that negatively impact the national security of the United States. With an interest in minimizing unintended consequences and addressing the national security risks posed by countries of concern developing technologies that are critical to the next generation of military, intelligence, surveillance, or cyber-enabled capabilities, the proposed rule includes detailed definitions and descriptions of terms and elements to appropriately scope coverage and facilitate compliance by United States persons. At the same time, the proposed rule seeks to avoid loopholes that could undermine the national security objectives of the Outbound Order. The Department of the Treasury seeks public input on how the proposed rule can best meet these important objectives.
Consistent with the Outbound Order, the proposed rule would place certain obligations upon any
The Outbound Order and the proposed rule seek to complement existing authorities and tools of the U.S. Government, including export controls and inbound investment reviews. However, the proposed rule would not entail a case-by-case review by the Department of the Treasury of
As noted in the ANPRM, it is not proposed that the program provide for retroactive application of the provisions related to the prohibition of certain transactions and the notification of others. However, the Department of the Treasury may, after the effective date of the regulations, request information about transactions by
In section IV, the Department of the Treasury seeks comment from stakeholders with respect to the proposed rule, accompanied by empirical data or other specific information wherever possible. The Department of the Treasury invites comments on the range of proposals in the proposed rule, and particularly as related to the specific provisions discussed in this section III.
This subpart includes a general discussion of the proposed rule's scope, how the proposed rule relates to other laws and regulations, proposed guidance on how to interpret and apply certain terms and provisions, the application of the knowledge standard in certain circumstances, and, consistent with the Outbound Order, the role of the heads of other relevant agencies in the implementation and administration of the proposed rule.
With respect to the knowledge standard specifically, because a
In light of these considerations, the proposed rule specifies that certain provisions, including in the definition of
The Department of the Treasury has considered the practical application of this approach. More specifically, if a
Commenters to the ANPRM requested a range of additional items from the Department of the Treasury that would assist a
One of the categories of covered national security technologies and products in the Outbound Order is sensitive technologies and products in the artificial intelligence (AI) sector. As discussed in the ANPRM, the U.S. Government is concerned with the development of
The ANPRM provided an initial definition for “AI system” as “an engineered or machine-based system that can, for a given set of objectives, generate outputs such as predictions, recommendations, or decisions influencing real or virtual environments. AI systems are designed to operate with varying levels of autonomy.”
Commenters to the ANPRM requested that the Department of the Treasury align terms with other U.S. Government programs where possible. After the Outbound Order and ANPRM were published, the President issued Executive Order 14110, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” on October 30, 2023 (the AI Order), which, among other things, establishes new standards for AI safety and security. The AI Order provides definitions for the terms “artificial intelligence” and “AI system” which this proposed rule incorporates in the definition of
The proposed rule would define
The definition of
If a
The following examples illustrate the application of the proposed definition of
(1)
(2)
(3)
(4)
The Department of the Treasury invites comments regarding this definition, including considerations with respect to coverage of entities established outside of the United States.
The proposed rule identifies activities that would provide the relevant nexus between the
The three primary definitions in the proposed rule implementing the term “covered national security technologies and products” are
The proposed definitions of
Those
The Outbound Order requires the Department of the Treasury to prohibit or require notification of certain transactions involving a
First, a person would be a
Second, a person would be a
Under this second set of circumstances, the Department of the Treasury intends to capture those entities that, while not directly engaged in a
Lastly, a
The following examples illustrate the application of the proposed definition of
(5)
(6)
The Department of the Treasury invites comments regarding this definition, including its application to a U.S. entity or a third-country entity.
In response to the ANPRM, some commenters requested that the definition of
In response to the ANPRM, some commenters requested that the Department of the Treasury maintain a publicly available list of
As discussed in greater detail below, the definition of
• Acquisition of an equity interest or contingent equity interest in a
• Provision of debt financing convertible to an equity interest in a
• Conversion of a contingent equity interest or convertible debt in a
• Greenfield investment or certain other corporate expansions that either will establish a
• Entrance into a joint venture, wherever located, with a
• Investment as a limited partner or equivalent (LP) into a non-
Each of the above transaction types includes a specific requirement for what a
The definition of
The definition of
The definition of
The definition of
The definition of
The definition of
The definition of
First, it would cover only an investment into a non-
Second, it would cover an investment only when the
Third, this approach would cover an LP investment only when the pooled investment fund undertakes an investment that would be a
To address a potential loophole, a
As set forth in the proposed rule, a transaction that otherwise has the attributes of a
The following examples illustrate the application of the proposed definition of
(7)
(8)
(9)
Some commenters to the ANPRM requested that certain other activities be either included in the definition of
Under § 850.210(b)(ii), consistent with the Outbound Order, a transaction undertaken for the conduct of the official business of the United States Government by employees, grantees, or contractors thereof would not be a
The proposed rule includes a definition of
The proposed rule defines
A
The submission of information to the Department of the Treasury regarding a
The
The
(1) Designed to be used for any government intelligence or mass-surveillance end use (
(2) Intended by the relevant
(3) Trained using a quantity of computing power greater than a certain level of computational operations (
This approach to covering the development of an
This defined term is a component of the definitions of
The definition would also include the government of a
Finally, the definition would include any entity, wherever located, in which one or more
The following examples illustrate the application of the proposed definition of
(10)
(11)
A
The
The
The
The
The
The
Some commenters to the ANPRM noted that the AI definitions under consideration in connection with a
The Department of the Treasury, in consultation with other departments and agencies, has determined that the
The definition of
The proposed rule would apply to the conduct of a
Some commenters to the ANPRM raised questions about the potential extraterritorial reach of the proposed rule as it relates to this term. Depending on how
Some commenters to the ANPRM noted that the potential inclusion of “any person in the United States” in this definition could scope in a non-
This subpart of the proposed rule describes activities that would be prohibited. Such activities would include a
Subpart C includes a prohibition on a
In the ANPRM, the Department of the Treasury noted that it was considering applying this provision to situations where a
The Department of the Treasury's proposed approach to this provision is guided by several goals: (1) establishing a clear standard so a
Under the proposed rule, a
In response to commenter questions on the ANPRM about whether this provision would apply only to the activity of
The following example illustrates the application of the proposed definition of
(12)
Wherever possible, consistent with national security objectives, the Department of the Treasury seeks to avoid broad implications on the employment of
This subpart of the proposed rule would require a
• If it undertakes a
• If its
• If the
In each of the above circumstances, the
The requirement to notify the Department of the Treasury in § 850.403 would apply to circumstances in which a
Some commenters stated that certain of the information considered in the ANPRM as elements of a complete notification could be difficult to obtain or burdensome to provide and cautioned that certain information requirements could have an unintended chilling effect on transactions in the relevant activities described in the ANPRM. The proposed rule seeks to address the national security threat described in the Outbound Order while minimizing unintended consequences. In light of this, the proposed rule contains information requirements for a
In response to comments to the ANPRM that a requirement to submit a notification before the
The following example illustrates the application of the proposed definition of
(13)
This subpart of the proposed rule specifies particular factors that would cause an otherwise
In keeping with the goal of tailoring the proposed rule to address the national security threat described in the Outbound Order while minimizing disruptive effects on
As discussed in detail below, an
• An investment by a
• An investment by a
• An investment of a certain size by a
• A
• An intracompany transaction between a
• Fulfillment of a
• The acquisition of a voting interest in a
• Certain transactions that occur in a country or territory outside the United States that has been designated by the Secretary in accordance with provisions set forth in § 850.501(f) of the proposed rule.
To make sure these exceptions are consistent with the policy objectives, certain of the transactions described
The ANPRM proposed an exception for an investment into a publicly traded security, with “security” defined as set forth in section 3(a)(1) of the Securities Exchange Act of 1934. In response to the ANPRM, some commenters requested that the definition of “publicly traded security” be broadened from the definition of “security” used in the discussion of excepted transactions in the ANPRM to align with the definition used by the Department of the Treasury's Office of Foreign Assets Control in connection with the Non-SDN Chinese Military-Industrial Complex Companies List. The proposed rule would effectively broaden the carveout to include a security traded on a non-U.S. exchange, or a security traded “over-the-counter,” in addition to a security traded on a U.S. exchange. The proposed rule would adopt this suggestion because a
The proposed rule also would provide an exception for investment in securities issued by an investment company, such as an index fund, mutual fund, or exchange traded fund, as well as a business development company under the Investment Company Act of 1940, as amended.
Similarly, a
Under proposed Alternate 1, a
Under proposed Alternate 2, a
An
An
Consistent with the ANPRM, the proposed definition of
The definition of
The Department of the Treasury, together with the Departments of State and Commerce and other agencies, recognize the importance of working with our partners and allies and will continue coordinating closely to address our shared national security concerns posed by outbound investment. In recognition of the shared objectives and in furtherance of the U.S. Government's efforts to encourage partners and allies address risks posed by outbound investment, the proposed rule would also provide for the potential application of the term
The proposed rule would provide for the application of this exception only to certain types of transactions with or involving a person of a designated country or territory. The proposed rule anticipates that the Secretary would determine the types of transactions for which the related national security concerns are likely to be adequately addressed by measures taken or that may be taken by the government of a country or territory outside the United States. Once developed, the Department of the Treasury intends to make factors for the designation of a country or territory as well as types of transactions and/or activities that would be subject to the exception publicly available on Treasury's Outbound Investment Security Program website. The Department of the Treasury, along with the Departments of State and Commerce, will continue to work with partners and allies as they explore addressing the national security concerns posed by certain outbound investments. The Department of the Treasury invites comments and input on the proposed factors for the Secretary to consider when designating a country or territory in this context as well as comments on the types of transactions or activities that should be excepted once a country or territory has been designated. Additionally, the Department of the Treasury invites comments more generally on efforts to engage internationally on outbound investment security.
The Outbound Order authorizes the Secretary to “exempt from applicable prohibitions or notification requirements any transaction or transactions determined by the Secretary, in consultation with the heads of relevant agencies, as appropriate, to be in the national interest of the United States.”
On a case-by-case basis, the Secretary, in consultation with the Secretary of Commerce, the Secretary of State, and the heads of relevant agencies, as appropriate, may determine that a
This section of the proposed rule describes the process and considerations for such a determination. Any determination that a covered transaction is in the national interest of the United States and therefore exempt from certain provisions will be based on a consideration of the totality of the facts and circumstances. The Department of the Treasury anticipates that such determination may be informed by, among other considerations, the transaction's effect on critical U.S. supply chain needs, domestic production needed for projected national defense requirements, the United States' technological leadership globally in areas affecting U.S. national security, and the impact on national security from prohibiting a given transaction. The Department of the Treasury is
In order to request a national interest exemption, a
Once developed, the Department of the Treasury anticipates detailing the process and required information for any national interest exemption request on the Department of the Treasury's Outbound Investment Program website.
This subpart of the proposed rule describes conduct that would be treated as a violation of the proposed rule. Such
This subpart of the proposed rule describes the penalties that would be applicable to violations of the proposed rule by any person subject to the jurisdiction of the United States, which would include civil and criminal penalties up to the maximum amount set forth in section 206 of IEEPA. Under the proposed rule, the Department of the Treasury may impose a civil penalty on any person that violates the rule, and the Secretary may refer potential criminal violations under the proposed rule to the Attorney General. Further, the proposed rule states that the Secretary, in consultation with the heads of relevant agencies, may take action to nullify, void, or otherwise compel divestment of any
This subpart describes the Department of the Treasury's proposal to treat as confidential, subject to limited exceptions, information and documentary materials that are submitted pursuant to the regulations and that are not otherwise publicly available. Except to the extent required by law or in accordance with one of the enumerated exceptions, the Department of the Treasury would not disclose such information publicly.
However, consistent with the exceptions set forth in the proposed rule, the Department of the Treasury would be permitted to disclose information that would otherwise be treated as confidential in certain limited circumstances; for example, the Department of the Treasury could disclose information to U.S. partners and allies where the information is important for the national security analysis or actions of the Department of the Treasury or such partners and allies, and subject to appropriate safeguards. Separately, under the proposed rule, the Department of the Treasury could use information submitted to fulfill its obligations under the Outbound Order, which include the requirement to prepare annual reports to the President in coordination with the Secretary of Commerce and in consultation with the heads of other relevant agencies, as appropriate, and could include anonymized data gathered pursuant to this part.
The Department of the Treasury is considering whether there are additional circumstances where disclosure of otherwise confidential information should be permitted. One proposal under consideration would allow the Department of the Treasury to disclose such information to the public as and when the Secretary determines that such disclosure is in the national interest: for example, to promote compliance with the proposed regulations by sharing with the public information about the activities of particular persons of a country of concern. The Department of the Treasury expects that such an exception would be subject to a high bar and limited to circumstances in which the Secretary identifies a pressing national interest that disclosure could help to address. This exception would not supersede any applicable statutory restrictions that may constrain the sharing of certain categories of information, such as information that a party has identified as protected trade secrets information. The Department of the Treasury invites comments on the considerations that it should take into account in identifying the scope of this potential additional exception to confidential treatment, the standard that should apply to the Secretary's determination, and what safeguards may be applicable to disclosure when such an exception applies.
This subpart of the proposed rule contains provisions related to the delegation of the Secretary's authorities under the Outbound Order, any amendment to or modification of the proposed rule, and a requirement for certain information regarding any transaction to be furnished upon demand. The proposed rule states that, consistent with the statutory authority on which the Outbound Order and the proposed rule are based, the Department of the Treasury has the power to investigate conduct that may constitute a violation, hold hearings, call witnesses, and require in-person testimony or production of documents, among other powers listed in § 850.904.
Subpart I would also establish, in § 850.903, that the provisions of the rule are severable from one another. If any of the provisions of this rule as finalized, or the application thereof to any person or circumstance, were to be held invalid, such invalidity would not affect other provisions or application of such provisions to other persons or circumstances that can be given effect without the invalid provision or application.
The Department of the Treasury invites comments on any and all aspects of the proposed rule, including and on the specific provisions discussed above in section III and the questions below. The Department of the Treasury invites comments accompanied by empirical data or other specific information wherever possible.
1. Are there areas where the proposed rule is broader than necessary to address the national security concerns identified in the Outbound Order? Are there areas where it is narrower than necessary or contains loopholes? If so, where and what adjustments should be made?
2. How could the knowledge standard in the proposed rule be clarified? What, if any, alternatives should be considered? What other factors should be considered to assess whether a person conducted a reasonable and diligent inquiry?
3. What considerations should the Department of the Treasury take into account with respect to the ease or difficulty with which a
4. Are there adjustments to the scope of
5. Is the line between the
6. How do
7. Are there adjustments to the types and scope of
8. How, if at all, should the definition of
9. How, if at all, should the definition of
10. Could the proposed approach to defining an indirect
11. The definitions of
12. The proposed definition of
13. What are the legal, commercial, practical or other consequences of including in, or conversely excluding from, the definition of
14. What are the considerations for
15. What would be the impact of a prohibition on
16. What would be the impact of a prohibition on
17. How should the Department of the Treasury ensure the regulations remain responsive to changes in the sectors identified in the Outbound Order (
18. How, if at all, could the prohibition on
19. What is the practical utility of a recusal carveout from the prohibition on
20. What challenges, if any, are anticipated in connection with the information required to be submitted for a
21. Are there categories of transactions that should be added to, or removed from, the definition of
22. Which of the two proposed alternates for the exception for LP investments in the definition of
23. What adjustments, if any, should be made to the proposed rule to clarify the coverage with respect to a greenfield investment, brownfield investment, or joint venture that is a
24. What is the value to stakeholders of including a national interest exemption for
25. What specific information should the Department of the Treasury require from a
This rulemaking pertains to a foreign affairs function of the United States and therefore is not subject to the rulemaking requirements of the Administrative Procedure Act (APA) (5 U.S.C. 553), which exempts a rulemaking from notice and comment requirements “to the extent there is involved . . . a military or foreign affairs function of the United States.” 5 U.S.C. 553(a)(1). As required by the Outbound Order, the proposed rule is being issued to assist in addressing the national emergency declared by the President with respect to the national security threat posed by countries of concern developing technologies that are critical to the next generation of military, intelligence, surveillance, or cyber-enabled capabilities. As described in the Outbound Order, this threat to the national security of the United States has its source in whole or substantial part outside the United States. The proposed rule would have a direct impact on foreign affairs concerns, which include the protection of national security against external threats (for example, limiting investment in specific sectors in designated countries of concern). Although the proposed rule is not subject to the notice and comment requirements of the APA, the Department of the Treasury is engaging in notice and comment rulemaking for this proposed rule, consistent with section 1(a) of the Outbound Order. In addition, the proposed rule was designated as significant under Executive Order 12866, as amended, and was reviewed by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB). The Department of the Treasury has undertaken an analysis of the anticipated costs and benefits of the proposed rule. Following the issuance of the ANPRM, a number of stakeholders commented about the potential burden associated with this program, which is novel in its approach to addressing the national security concern posed by U.S. outbound investments involving a country of concern. The Department of the Treasury, after taking into account these comments and the novelty of the program, conducted an analysis of the relative costs and benefits of the proposed rule. For purposes of this analysis, the Department of the Treasury assessed the costs and benefits of the proposed rule relative to a no-action baseline reflecting
In addition, this section includes the required assessments of the reporting and recordkeeping burdens under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
Executive Orders 12866, 13563, and 14094 direct agencies to assess the costs and benefits of available regulatory alternatives for certain types of rulemaking in certain circumstances and, if regulation is necessary, to select regulatory approaches that maximize net benefits. The Department of the Treasury has conducted an assessment of the costs and benefits of the proposed rule, as well as the costs and benefits of available regulatory alternatives.
As noted above in section I, the Outbound Order directs the Secretary to establish a program to prohibit
As described above in section I, this proposed rule is consistent with the President's mandate in the Outbound Order and prescribes procedures and obligations governing the (1) prohibition of certain types of investment by
The proposed rule would cover a defined set of transactions such as certain acquisitions of equity interests (
The primary direct costs to the public associated with the proposed rule would relate to (1) understanding the proposed rule; (2) conducting the transaction-specific diligence that would be needed for a
The proposed rule would apply to all
For purposes of this analysis, the Department of the Treasury doubled the averages from the available data to account for the likely underrepresentation of potentially relevant transactions. Thus, the Department of the Treasury's analysis is based on the estimate of approximately 120 entities and 212 transactions annually (based on an assumption of an annual average of 1.77 transactions per entity) that may be affected by the proposed rule. The Department of the Treasury is soliciting comments on the reasonableness of this estimate (in terms of the data source and analysis), and whether there are other sources of data that the Department of the Treasury should consider for its cost analysis. The Department of the Treasury also invites comments on whether doubling the averages from publicly available data is a reasonable way to account for any underrepresentation of potentially relevant transactions, or whether a different methodology should be used. For the remainder of this analysis, however, the Department of the Treasury relied on the estimates as described above.
To derive an estimate for the costs related to the proposed rule, the Department of the Treasury first estimated the associated labor costs related to interpreting and applying the proposed rule. The Department of the Treasury expects that individuals and entities reviewing the proposed rule and engaging in potentially relevant transactions would engage on their own and through their own employees as well as hire lawyers or advisors from outside firms.
For a low-end estimate, the Department of the Treasury relied on a figure from the Bureau of Labor Statistics (BLS), which reports the mean hourly wage for Standard Occupational Classification System Code (SOC Code) 231011—Lawyers to be $84.84 per hour and SOC Code 111021—General and Operations Managers to be $62.18 per hour.
For a high-end estimate, the Department of the Treasury acknowledges that the hourly rate billed for a lawyer performing the relevant type of work at a private firm may be significantly higher than the average hourly wage of a lawyer from the BLS figure. The global data and business intelligence platform Statista reports that the average hourly attorney billing rate in Washington, DC, in 2023 was $392.
Based on the above assumptions and estimates of affected entities, number of transactions and labor costs, the Department of the Treasury has estimated the annual time and cost that would be spent by affected entities in understanding the proposed rule. While
The range of estimated aggregate annual costs for understanding the proposed rule begins at $468,520 on the low end and goes up to $614,800 on the high end. This is based on the estimate of an average time burden to be ten total person hours per transaction for understanding the proposed rule. As such, ten total person hours per transaction multiplied by 212 annual transactions and the low-end hourly labor cost range and high-end hourly labor cost range described above, respectively, result in the total cost range for understanding the proposed rule.
Based on the above assumptions and estimates of affected entities, number of transactions and labor costs, the Department of the Treasury has estimated the annual time and cost that would be spent by affected entities on conducting additional transactional diligence with respect to this proposed rule. These economic estimates should in no way be construed as relevant to the reasonableness of the inquiry a party would pursue in light of the particular facts and circumstances of a transaction and the requirements of the proposed rule. While recognizing that the extent of this diligence will necessarily vary from transaction to transaction, the Department of the Treasury arrived at the below estimates for purposes of this regulatory analysis.
The Department of the Treasury recognizes that most investment transactions, regardless of whether the investment is potentially subject to this proposed rule, involve some level of review, diligence, assessment, and recordkeeping by the investor. And, for some transactions and investors, the level of information collection, retention, and diligence necessary to comply with the proposed rule may not give rise to any costs beyond what would be incurred in the absence of the proposed rule. This conclusion is reached by focusing on the nature of the information required for a notification, which consists of data typically gathered or available in the process of making an investment. This includes, for example, the proposed information requirements regarding transaction party identifying information as well as the commercial rationale, transaction structure, financial details, and
The Department of the Treasury assesses that it is reasonable in some cases to assume that customary transactional due diligence would involve the collection and review of this required information, meaning that the only incremental costs would be incurred for the review of the information from the perspective of ensuring compliance with the proposed rule. While the notification requirement would also include (1) information regarding
The range of estimated annual incremental cost for conducting due diligence and recordkeeping associated with the proposed rule runs from $0 on the low end to $2,459,200 on the high end. These are two ends of the range, and it is anticipated that the costs for most transactions would fall between these figures. The Department of the Treasury estimates that the average time burden would likely not exceed 40 total person hours per transaction for conducting additional due diligence and recordkeeping with respect to the proposed rule.
For the low end of this range, it is reasonable to anticipate that some investors, having spent resources learning about the proposed rule, as discussed above, will be able to quickly collect and assess the information needed to determine whether a potential transaction would be a
The Department of the Treasury invites comments on whether these figures are reasonable benchmarks and estimates for this analysis or whether there are other sources of data or estimates it should consider.
The proposed rule would require the submission of information to the Department of the Treasury for notifiable transactions and provides for certain other circumstances that require information submission. The Department of the Treasury intends to require
The Department of the Treasury expects that of the universe of potentially
The estimated annual cost range for time spent submitting information would be $2,342,600 to $3,074,000. This estimate assumes 50 person hours per transaction for preparing and submitting a notification through an online portal, combined with the number of transactions per year (212) and the hourly labor cost range described above—$221 to $290. As discussed above, this number reflects the high-end estimate, since this analysis assumes that every potentially relevant transaction would result in a notification.
For purposes of this analysis, the Department of the Treasury estimated only the total annual costs of preparing and submitting a notification under § 850.404 of the proposed rule. The Department of the Treasury anticipates that the time and cost behind preparing and submitting a post-transaction notice, notice of any material omission or inaccuracy in any previous representation, statement, or certification, or responding to agency inquiries may be comparable to the costs of preparing and submitting a notification. Likewise, where a
Based on the direct cost estimates above, the total annual direct costs associated with complying with the proposed rule can be expected to have a range of between $2,811,120 and $6,148,000 and the total annual time burden would be approximately 21,200 person hours.
With respect to
Administering the regulation would also entail costs to the U.S. Government. Such costs would include information technology (IT) development and ongoing annual maintenance, as well as processing electronic notifications. The Department of the Treasury estimates that initial IT development costs would be between $4 million and $8 million with an additional $2 million to $3 million required to maintain the systems and the underlying technology being leveraged to support the capabilities. The Department of the Treasury and other relevant agencies, including the Department of Commerce, may incur additional costs, besides those estimated above. This includes other responsibilities related to the implementation of the proposed rule such as analyzing notifications submitted as well as complying with the reporting requirements under the Outbound Order. Furthermore, costs may be associated with efforts to promote compliance with the notification requirement and prohibition requirements, potentially including education on the requirements, development of guidance and frequently asked questions, and conducting stakeholder outreach. The Department of the Treasury does not currently have specific estimates for these costs but estimates that there would be personnel costs of less than $2 million associated with the proposed regulation in Fiscal Year 2024 with additional costs for ongoing outreach and enforcement thereafter.
The Department of the Treasury and other government agencies may also incur costs in enforcing compliance with the regulation. The Department of the Treasury does not currently have estimates for these costs, and they are not included in the estimates above.
The Department of the Treasury plans to monitor compliance with the final regulation by leveraging a variety of data sources, both internal and external. Because the external data sources may include third parties, the Department of the Treasury requests comment on what external data sources would be appropriate to leverage in identifying non-compliance with respect to the regulations and what potential costs may be incurred by such third parties. If the external data sources include third party commercial data, the Department of the Treasury assesses that the cost associated with accessing these databases would be modest and incremental, given that the Department of the Treasury regularly maintains access to such databases in the course of other work but may need to request additional licenses for employees. After identifying an instance of apparent non-compliance, the Department of the Treasury may initiate outreach to the involved entity, work with law enforcement to investigate the apparent non-compliance, or initiate an enforcement action. The Department of the Treasury's enforcement of the proposed regulation would also involve coordination with law enforcement agencies. These law enforcement
The President found in the Outbound Order that the advancement by
The proposed rule is designed to complement our existing tools and effectively address the threat to the national security of the United States described in the Outbound Order. The benefit of protecting national security is difficult to quantify. Furthermore, the notification component of the proposed rule is intended to provide key information that the Department of the Treasury could use to better inform the development and implementation of the program. These notifications would increase the U.S. Government's visibility into transactions by
The Outbound Order requires the Secretary of the Treasury to issue implementing regulations subject to public notice and comment. As a result, the Department of the Treasury did not have the discretion to refrain from promulgating the proposed rule or to promulgate it without notice and comment. However, the Department of the Treasury considered different approaches to the proposed rule that would be available under the Outbound Order. Specifically, the Department of the Treasury considered the following potential alternatives to the proposed rule:
•
The Department of the Treasury considered and selected regulatory approaches that maximize net benefits (including effectively addressing the national security threat identified in the Outbound Order) while balancing potential compliance and implementation costs. For example, an alternative that the Department of the Treasury considered in relation to contingent equity interests in particular was to limit the scope of
•
The Department of the Treasury intends that the proposed rule would provide a
The collections of information contained in this notice of proposed rulemaking have been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA).
The proposed rule would require a
The proposed rule would also require any
The collections of information described would be used by the Department of the Treasury and the Department of Commerce, and, as appropriate, other relevant agencies, in connection with the analysis of notifiable transactions pursuant to the Outbound Order. The information provided in the notifications would increase the U.S. Government's visibility into the volume and nature of
Written comments and recommendations for the proposed information collections can be submitted by visiting
The Department of the Treasury used the methodology described in the previous section to estimate the total annual reporting and recordkeeping burden of the information collections in this proposed rule. The Department of the Treasury estimates that the annual hourly burden would be up to 19,080 hours. This annual total is based on the Department of the Treasury's assumption that: (1) 120 entities per year would respond to the information collections in this proposed rule and each entity would submit an average of 1.77 notifications annually, meaning these respondents would file a total 212 responses to the information collections annually; and (2) each respondent would spend an estimated 50 to 90 person hours per response. The Department of the Treasury estimates that the annual cost burden associated with the information collections and recordkeeping in the proposed rule would range between $2,342,600 and $5,533,200.
In accordance with 5 CFR 1320.8(d)(1), the Department of the Treasury is soliciting comments from
(1) Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collections of information;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology.
Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the OMB.
It is hereby certified that the proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of section 601(6) of the Regulatory Flexibility Act (5 U.S.C. 601
The proposed rule may impact any
The Department of the Treasury expects the proposed rule to have a negligible baseline impact on small businesses because the proposed rule's obligations on
In fact, the total number of potential investors subject to the regulation is likely limited to a small set of relatively large and sophisticated investors. As discussed above, the Department of the Treasury considered PitchBook Data from approximately 2021 through 2023. Notably, the most common type of U.S. based investors in this survey were identified by PitchBook Data as a venture capital business, corporation, private equity or buyout firm, or comparable investor types.
Given the applications of technologies and products in these sectors, the Department of the Treasury believes investments into these sectors involving a
In the unlikely event that a small entity is subject to the requirements of the program, such entity would be expected to incur the costs described in the separate cost benefit analysis above. For submission of notifications, the Department of the Treasury has endeavored to develop information gathering procedures that minimize the burden on
Notwithstanding this certification, the Department of the Treasury invites comments from the public about the impact the proposed rule on small entities. The proposed rule will be submitted to the Chief Counsel for the Office of Advocacy of the Small Business Administration for comment on its impact on small business.
Administrative practice and procedure, Artificial intelligence, Business and industry, Confidential business information, Electronic filing, Executive orders, Foreign persons, Hong Kong, Holding companies, Investigations, Investments, Investment companies, Microelectronics, National defense, National security, Macau, Penalties, People's Republic of China, Quantum information technologies, Reporting and recordkeeping requirements, Science and technology, Securities, Semiconductors, U.S. investments abroad.
50 U.S.C. 1701
(a) This part implements Executive Order 14105 of August 9, 2023, “Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern” (the Order), directing the Secretary of the Treasury (the Secretary), in consultation with the Secretary of Commerce and, as appropriate, the heads of other relevant executive departments and agencies, to issue, subject to public notice and comment, regulations that require U.S. persons to provide notification of information relative to certain transactions involving covered foreign persons and that prohibit U.S. persons from engaging in certain other transactions involving covered foreign persons.
(b) The regulations identify certain types of transactions that are
(c) The regulations identify categories of
(d) The regulations identify categories of
(e) Pursuant to the Order, the Secretary shall, as appropriate:
(1) Communicate with the Congress and the public with respect to the
implementation of the Order;
(2) Consult with the Secretary of Commerce on industry engagement and analysis of notifiable transactions;
(3) Consult with the Secretary of State, the Secretary of Defense, the Secretary of Commerce, the Secretary of Energy, and the Director of National Intelligence on the implications for military, intelligence, surveillance, or cyber-enabled capabilities of covered national security technologies and products in the Order and potential
(4) Engage, together with the Secretary of State and the Secretary of Commerce, with allies and partners regarding the national security risks posed by countries of concern advancing covered national security technologies and products;
(5) Consult with the Secretary of State on foreign policy considerations related to the implementation of the Order, including but not limited to the issuance and amendment of regulations; and
(6) Investigate, in consultation with the heads of relevant agencies, as appropriate, violations of the Order or the regulations in this part and pursue available civil penalties for such violations.
Nothing in this part shall be construed as altering or affecting any other authority, process, regulation, investigation, enforcement measure, license, authorization, or review provided by or established under any other provision of federal law, including the International Emergency Economic Powers Act (50 U.S.C. 1701
(a) As used in this part, the term “including” (or variations such as “include”) means “including but not limited to.”
(b) Any term in the singular includes the plural, and the plural includes the singular, if such use would be appropriate.
(c) Section headings are included for convenience of reference only and shall not affect the interpretation of this part.
(a) Certain provisions of this part apply only if a U.S. person
(b) Such assessment as to whether, at the time of a given transaction, a U.S. person has or had knowledge of a given fact or circumstance will be made based on information a U.S. person had or could have had through a reasonable and diligent inquiry. A U.S. person that has failed to conduct a reasonable and diligent inquiry by the time of a given transaction may be assessed to have had reason to know of a given fact or circumstance, including facts or circumstances that would cause the transaction to be a covered transaction.
(c) In assessing whether a U.S. person has undertaken such a reasonable and diligent inquiry, the Department of the Treasury's considerations will include the following, as applicable, among others that the Department of the Treasury deems relevant, with respect to a particular transaction:
(1) The inquiry a U.S. person, its legal counsel, or its representatives have made on behalf of the U.S. person regarding an investment target or relevant counterparty, including questions asked of the investment target or relevant counterparty, as of the time of the transaction;
(2) The contractual representations or warranties the U.S. person has obtained or attempted to obtain from the investment target or relevant counterparty with respect to the determination of a transaction's status as a covered transaction and an investment target or relevant counterparty's status as a covered foreign person;
(3) The effort by the U.S. person at the time of the transaction to obtain available non-public information relevant to the determination of a transaction's status as a covered transaction and an investment target or relevant counterparty's status as a covered foreign person, and the efforts undertaken by the U.S. person to obtain and review such information;
(4) Available public information, the efforts undertaken by the U.S. person to obtain and review such information, and the degree to which other information available to the U.S. person at the time of the transaction is consistent or inconsistent with such publicly available information;
(5) Whether the U.S. person, its legal counsel, or its representatives have purposefully avoided learning or sharing relevant information;
(6) The presence or absence of warning signs, which may include evasive responses or non-responses from an investment target or relevant counterparty to questions or a refusal to provide information, contractual representations, or warranties; and
(7) The use of public and commercial databases to identify and verify relevant information of an investment target or relevant counterparty.
The term
The term
(a) A machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments—
(1) Perceive real and virtual environments;
(2) Abstract such perceptions into models through automated or algorithmic statistical analysis; and
(3) Use model inference to make a classification, prediction, recommendation, or decision.
(b) Any data system, software, hardware, application, tool, or utility that operates in whole or in part using a system described in (a).
(a) The term
(1) Fully complies with the regulations in this part; and
(2) Is accurate and complete in all material respects to the best knowledge of the person filing a notification or other information.
(b) For purposes of this section, a duly authorized designee is:
(1) In the case of a partnership, any general partner thereof;
(2) In the case of a corporation, any officer thereof; and
(3) In the case of any entity lacking partners and officers, any individual within the organization exercising executive functions similar to those of a general partner of a partnership or an officer of a corporation or otherwise authorized by the board of directors or equivalent to provide such certification.
(c) In each case described in paragraphs (b)(1) through (3) of this section, such designee must possess actual authority to make the certification on behalf of the person filing a notification or other information.
A template for certifications may be found at the Outbound Investment Security Program section of the Department of the Treasury website.
The term
(a) With respect to a covered transaction other than under § 850.210(a)(6), the earliest date upon which any interest, asset, property, or right is conveyed, assigned, delivered, or otherwise transferred to a U.S. person, or as applicable, its controlled foreign entity; or
(b) With respect to a covered transaction under § 850.210(a)(6), the earliest date upon which any interest, asset, property, or right in the relevant covered foreign person is conveyed, assigned, delivered, or otherwise transferred to the applicable fund.
The term
(a) The term
(b) For purposes of this term, the following rules shall apply in determining whether an entity is a parent of another entity in a tiered ownership structure:
(1) Where the relationship between an entity and another entity is that of parent and subsidiary, the holdings of voting interest or voting power of the board, as applicable, of a subsidiary shall be fully attributed to the parent.
(2) Where the relationship between an entity and another entity is not that of parent and subsidiary (
(3) Where the circumstances in paragraphs (b)(1) and (2) of this section apply (
The term
The term
(a) The term
(1) A person of a country of concern that engages in a covered activity; or
(2) A person that directly or indirectly holds any voting interest, board seat, or equity interest in any person described in paragraph (a)(1) of this section, or holds any power to direct or cause the direction of the management or policies of any person described in paragraph (a)(1) of this section through one or more contractual arrangements, including, for the avoidance of doubt, variable interest entities; and where the person, based the relevant financial statement described in paragraph (b) of this section:
(i) Derives more than 50 percent of its revenue from any person described in paragraph (a)(1) of this section, individually or in the aggregate;
(ii) Derives more than 50 percent of its net income from any person described in paragraph (a)(1) of this section, individually or in the aggregate;
(iii) Incurs more than 50 percent of its capital expenditure through any person described in paragraph (a)(1) of this section, individually or in the aggregate; or
(iv) Incurs more than 50 percent of its operating expenses through any person described in paragraph (a)(1) of this section, individually or in the aggregate.
(3) With respect to a covered transaction described in § 850.210(a)(5), the person of a country of concern that participates in the joint venture is deemed to be a covered foreign person by virtue of its participation in the joint venture.
(b) Determination of whether a person is a covered foreign person within the meaning of paragraph (a)(2) of this section shall be made based on an annual financial statement from the most recent year for which an audited financial statement of such person is available at the time of a given transaction. If an audited financial statement is not available, the most recent unaudited financial statement shall be used instead.
(a) The term
(1) Acquisition of an equity interest or a contingent equity interest (or interest equivalent to an equity or contingent equity interest) in a person that the U.S. person knows at the time of the acquisition is a covered foreign person;
(2) Provision of a loan or a similar debt financing arrangement to a person that the U.S. person knows at the time of the provision is a covered foreign person, where such debt financing:
(i) Is convertible to an equity interest; or
(ii) Affords or will afford the U.S. person the right to make management decisions with respect to or on behalf of the covered foreign person or the right to appoint members of the board of directors (or equivalent) of the covered foreign person;
(3) Conversion of a contingent equity interest (or interest equivalent to a contingent equity interest) or conversion of debt to an equity interest in a person that the U.S. person knows at the time of the conversion is a covered foreign person;
(4) Acquisition, leasing, or other development of operations, land, property, or other assets in a country of concern that the U.S. person knows at the time of such acquisition, leasing, or other development will result in, or that the U.S. person intends to result in:
(i) The establishment of a covered foreign person; or
(ii) The engagement of a person of a country of concern in a covered activity where it was not previously engaged in such covered activity;
(5) Entrance into a joint venture, wherever located, that is formed with a person of a country of concern and that the subject U.S. person knows at the time of entrance into the joint venture will engage in or the U.S. person intends to engage in a covered activity; or
(6) Acquisition of a limited partner or equivalent interest in a venture capital fund, private equity fund, fund of funds, or other pooled investment fund (in each case where the fund is not a U.S. person) that a U.S. person knows at the time of the acquisition likely will invest in a person of a country of concern that is in the semiconductors and microelectronics, quantum information technologies, or artificial intelligence sectors, and such fund undertakes a transaction that would be a covered transaction if undertaken by a U.S. person.
(b) Notwithstanding paragraph (a) of this section, a transaction is not a covered transaction if it is:
(1) An excepted transaction as set forth in § 850.501; or
(2) For the conduct of the official business of the United States Government by employees, grantees, or contractors thereof.
(c) The acquisition of a convertible or contingent interest described in paragraph (a)(1) or (2) of this section may constitute a covered transaction, and the subsequent occurrence of a conversion event described in paragraph (a)(3) of this section may constitute a separate covered transaction. A U.S. person should assess each of the acquisition and the conversion to determine the applicability of this part.
For the avoidance of doubt, in the context of a debt financing, a lender's foreclosure on collateral that constitutes an equity interest is an acquisition of such equity interest by the lender.
The term
The term
The term
The term
The term
Knowledge of a fact or circumstance (the term may be a variant, such as “know”) means:
(a) Actual knowledge that a fact or circumstance exists or is substantially certain to occur;
(b) An awareness of a high probability of a fact or circumstance's existence or future occurrence; or
(c) Reason to know of a fact or circumstance's existence.
See the discussion of the knowledge standard in § 850.104 for more information about how this term is applied in this part.
The term
(a) Designs any integrated circuit that is not described in § 850.224(c);
(b) Fabricates any integrated circuit that is not described in § 850.224(d);
(c) Packages any integrated circuit that is not described in § 850.224(e); or
(d) Develops any AI system that is not described in § 850.224(j) or (k) and that is:
(1) Designed to be used for any government intelligence or mass-surveillance end use (
(2) Intended by the covered foreign person to be used for cybersecurity applications, digital forensics tools, and penetration testing tools, or the control of robotic systems; or
(3) Trained using a quantity of computing power greater than 10^23 computational operations (
(3) Trained using a quantity of computing power greater than 10^24 computational operations (
(3) Trained using a quantity of computing power greater than 10^25 computational operations (
Consistent with section 3 of the Order, the Secretary, in consultation with the Secretary of Commerce, and, as appropriate, the heads of other relevant agencies, shall periodically assess whether the quantity of computing power described in paragraph (d)(3) remains effective in addressing threats to the national security of the United States described in the Order and make updates, as appropriate, through public notice.
The term
The term
(a) A person who or which directly or indirectly holds more than 50 percent of:
(1) The outstanding voting interest in the entity; or
(2) The voting power of the board of the entity;
(b) The general partner, managing member, or equivalent of the entity; or
(c) The investment adviser to any entity that is a pooled investment fund, with “investment adviser” as defined in the Investment Advisers Act of 1940 (15 U.S.C. 80b-2(a)(11)).
The term
The term
(a) Any individual that:
(1) Is a citizen or permanent resident of a country of concern;
(2) Is not a U.S. citizen; and
(3) Is not a permanent resident of the United States.
(b) An entity with a principal place of business in, headquartered in, or
(c) The government of a country of concern, including any political subdivision, political party, agency, or instrumentality thereof; any person acting for or on behalf of the government of such country of concern; or any entity with respect to which the government of such country of concern holds individually or in the aggregate, directly or indirectly, 50 percent or more of the entity's outstanding voting interest, voting power of the board, or equity interest, or otherwise possesses the power to direct or cause the direction of the management and policies of such entity (whether through the ownership of voting securities, by contract, or otherwise);
(d) Any entity in which one or more persons identified in paragraph (a), (b), or (c) of this section, individually or in the aggregate, directly or indirectly, holds at least 50 percent of any of the following interests of such entity: outstanding voting interest, voting power of the board, or equity interest; or
(e) Any entity in which one or more persons identified in paragraph (d) of this section, individually or in the aggregate, directly or indirectly, holds at least 50 percent of any of the following interests of such entity: outstanding voting interest, voting power of the board, or equity interest.
The term
The term
The term
(a) Develops or produces any electronic design automation software for the design of integrated circuits or advanced packaging;
(b) Develops or produces any:
(1) Front-end semiconductor fabrication equipment designed for performing the volume fabrication of integrated circuits, including equipment used in the production stages from a blank wafer or substrate to a completed wafer or substrate (
(2) Equipment for performing volume advanced packaging; or
(3) Commodity, material, software, or technology designed exclusively for use in or with extreme ultraviolet lithography fabrication equipment.
(c) Designs any integrated circuit that meets or exceeds the performance parameters in Export Control Classification Number 3A090.a in supplement No. 1 to 15 CFR part 774, or integrated circuits designed for operation at or below 4.5 Kelvin;
(d) Fabricates any integrated circuit that meets any of the following criteria:
(1) Logic integrated circuits using a non-planar transistor architecture or with a production technology node of 16/14 nanometers or less, including fully depleted silicon-on-insulator (FDSOI) integrated circuits;
(2) NOT-AND (NAND) memory integrated circuits with 128 layers or more;
(3) Dynamic random-access memory (DRAM) integrated circuits using a technology node of 18 nanometer half-pitch or less;
(4) Integrated circuits manufactured from a gallium-based compound semiconductor;
(5) Integrated circuits using graphene transistors or carbon nanotubes; or
(6) Integrated circuits designed for operation at or below 4.5 Kelvin;
(e) Packages any integrated circuit using advanced packaging techniques;
(f) Develops, installs, sells, or produces any supercomputer enabled by advanced integrated circuits that can provide a theoretical compute capacity of 100 or more double-precision (64-bit) petaflops or 200 or more single-precision (32-bit) petaflops of processing power within a 41,600 cubic foot or smaller envelope;
(g) Develops a quantum computer or produces any of the critical components required to produce a quantum computer such as a dilution refrigerator or two-stage pulse tube cryocooler;
(h) Develops or produces any quantum sensing platform designed for, or which the relevant covered foreign person intends to be used for, any military, government intelligence, or mass-surveillance end use;
(i) Develops or produces any quantum network or quantum communication system designed for, or which the relevant covered foreign person intends to be used for:
(1) Networking to scale up the capabilities of quantum computers, such as for the purposes of breaking or compromising encryption;
(2) Secure communications, such as quantum key distribution; or
(3) Any other application that has any military, government intelligence, or mass-surveillance end use;
(j) Develops any AI system that is designed to be exclusively used for, or which the relevant covered foreign person intends to be used for, any:
(1) Military end use (
(2) Government intelligence or mass surveillance end use (
(k) Develops any AI system that is trained using a quantity of computing power greater than:
(1) 10^24 computational operations (
(1) 10^25 computational operations (
(1) 10^26 computational operations (
(2) 10^23 computational operations (
(2) 10^24 computational operations (
(l) Meets the conditions set forth in § 850.209(a)(2) because of its relationship to one or more covered foreign persons engaged in any covered activity described in any of paragraphs (a) through (k) of this section; or
(m) Engages in a covered activity, whether referenced in this section or § 850.217 and is:
(1) Included on the Bureau of Industry and Security's Entity List (15 CFR part 744, supplement no. 4);
(2) Included on the Bureau of Industry and Security's Military End User List (15 CFR part 744, supplement no. 7);
(3) Meets the definition of “Military Intelligence End-User” by the Bureau of
(4) Included on the Department of the Treasury's list of Specially Designated Nationals and Blocked Persons (SDN List), or is an entity in which one or more individuals or entities included on the SDN List, individually or in the aggregate, directly or indirectly, own a 50 percent or greater interest;
(5) Included on the Department of the Treasury's list of Non-SDN Chinese Military-Industrial Complex Companies (NS-CMIC List); or
(6) Designated as a foreign terrorist organization by the Secretary of State under 8 U.S.C. 1189.
Consistent with section 3 of the Order, the Secretary, in consultation with the Secretary of Commerce and, as appropriate, the heads of other relevant agencies, shall periodically assess whether the quantities of computing power described in paragraph (k) of this section remain effective in addressing threats to the national security of the United States described in the Order and make updates, as appropriate, through public notice.
The term
The term
The term
The term
The term
A U.S. person may not engage in a prohibited transaction unless an exemption for that transaction has been granted under § 850.502.
(a) A U.S. person shall take all reasonable steps to prohibit and prevent any transaction by its controlled foreign entity that would be a prohibited transaction if engaged in by a U.S. person.
(b) If a controlled foreign entity engages in a transaction that would be a prohibited transaction if engaged in by a U.S. person, in determining whether the relevant U.S. person took all reasonable steps to prohibit and prevent such transaction, the Department of the Treasury will consider, among other factors, any of the following with respect to a U.S. person and its controlled foreign entity:
(1) The execution of agreements with respect to compliance with this part between the subject U.S. person and its controlled foreign entity;
(2) The existence and exercise of governance or shareholder rights by the U.S. person with respect to the controlled foreign entity, where applicable;
(3) The existence and implementation of periodic training and internal reporting requirements by the U.S. person and its controlled foreign entity with respect to compliance with this part;
(4) The implementation of appropriate and documented internal controls, including internal policies, procedures, or guidelines that are periodically reviewed internally, by the U.S. person and its controlled foreign entity; and
(5) Implementation of a documented testing and/or auditing process of internal policies, procedures, or guidelines.
Findings of violations of this section and decisions related to enforcement and penalties will be made based on a consideration of the totality of relevant facts and circumstances, including whether the U.S. person has taken the steps described in paragraph (b) of this section and whether such steps were reasonable given the size and sophistication of the U.S. person.
(a) A U.S. person is prohibited from knowingly directing a transaction by a non-U.S. person that the U.S. person knows at the time of the transaction would be a prohibited transaction if engaged in by a U.S. person. For purposes of this section, a U.S. person “knowingly directs” a transaction when the U.S. person has authority, individually or as part of a group, to make or substantially participate in decisions on behalf of a non-U.S. person, and exercises that authority to direct, order, decide upon, or approve a transaction. Such authority exists when a U.S. person is an officer, director, or senior advisor, or otherwise possesses senior-level authority at a non-U.S. person.
(b) A U.S. person that has the authority described in paragraph (a) of this section and recuses themself from an investment will not be considered to have exercised their authority to direct, order, decide upon, or approve a transaction.
A U.S. person that undertakes a notifiable transaction shall file a notification of that transaction with the Department of the Treasury pursuant to § 850.404.
A U.S. person shall file a notification with the Department of the Treasury pursuant to § 850.404 with respect to any transaction by a controlled foreign entity of that U.S. person that would be a notifiable transaction if engaged in by a U.S. person.
A U.S. person that acquires actual knowledge after the completion date of a transaction of a fact or circumstance such that the transaction would have been a covered transaction if such knowledge had been possessed by the relevant U.S. person at the time of the transaction shall promptly, and in no event later than 30 calendar days following the acquisition of such
For the avoidance of doubt, a U.S. person's submission of a notification pursuant to this section shall not preclude a finding by the Department of the Treasury that as a factual matter the U.S. person had relevant knowledge of the transaction's status at the time of the transaction.
(a) A U.S. person that has an obligation under §§ 850.401, 850.402, or 850.403 shall file an electronic copy of the notification of the transaction with the Department of the Treasury including the information set out in § 850.405 and the certification referred to in § 850.203. The U.S. person shall follow the electronic filing instructions posted on the Department of the Treasury's Outbound Investment Security Program website. No communications or submissions other than those described in this section shall constitute the filing of a notification for purposes of this part.
(b) The Department of the Treasury may contact a U.S. person that has filed a notification with questions or document requests related to the transaction or compliance with this part. The U.S. person shall respond to any such questions or requests within the time frame and in the manner specified by the Department of the Treasury. Information and other documents provided by the U.S. person to the Department of the Treasury after the filing of the notification under this section shall be deemed part of the notification and shall be subject to the certification referred to in § 850.203.
(c) A U.S. person shall file a notification under § 850.401 or § 850.402 with the Department of the Treasury no later than 30 calendar days following the completion date of a notifiable transaction. A U.S. person shall file a notification required under § 850.403 with the Department of the Treasury no later than 30 calendar days after it acquires the knowledge referred to in § 850.403.
(d) If a U.S. person files a notification prior to the completion date of the notifiable transaction, the U.S. person shall update such notification no later than 30 calendar days following the completion date of the notifiable transaction if information in the original filing has materially changed.
(e) A U.S. person shall inform the Department of the Treasury in writing no later than 30 calendar days following the acquisition of previously unavailable information required under § 850.405.
While the Department of the Treasury may engage with the U.S. person following notification, it is also possible the U.S. person will receive no communication from the Department of the Treasury other than an electronic acknowledgment of receipt after notification is submitted.
(a) A U.S. person that has an obligation under this part to file a notification shall provide the information set forth in this section, which must be accurate and complete in all material respects.
(b) A notification shall provide, as applicable:
(1) The contact information of a representative of the U.S. person filing the notification who is available to communicate with the Department of the Treasury about the notification including such representative's name, title, email address, mailing address, phone number, and employer;
(2) A description of the U.S. person, including name, and as applicable, principal place of business and place of incorporation or legal organization, company address, website, and, if the U.S. person is an entity, such U.S. person's ultimate owner;
(3) A post-transaction organizational chart of the U.S. person that includes its relationship with any controlled foreign entity or entities of the U.S. person and that identifies the covered foreign person and other relevant persons involved in the transaction;
(4) A brief description of the commercial rationale for the transaction;
(5) A brief description of why the U.S. person has determined the transaction is a covered transaction that includes a discussion of the nature of the transaction, its structure, reference to the paragraph of § 850.210(a) that best describes the transaction type, and whether the notification is being submitted pursuant to §§ 850.401, 850.402, or 850.403;
(6) The status of the transaction, including the actual or expected completion date of the transaction;
(7) The total transaction value in U.S. dollars or U.S. dollar equivalent, an explanation of how the transaction value was determined, and a description of the consideration for the transaction (including cash, securities, other assets, and debt forgiveness);
(8) The aggregate equity interest, voting interest, board seats (or equivalent holdings) of the U.S. person and its affiliates in the covered foreign person (or in the joint venture, as applicable) following the completion date of the transaction, including a description of any agreements or commitments for future investment or options to make future investments in the covered foreign person (or joint venture);
(9) Information about the covered foreign person, including its name, and as applicable, principal place of business and place of incorporation or legal organization, company address, website, and if the covered foreign person is an entity, such covered foreign person's ultimate owner, and the full legal names and titles of each officer, director, and other member of management of the covered foreign person, and a post-transaction organizational chart of the covered foreign person;
(10) Identification and description of each of the covered activity or activities undertaken by the covered foreign person that makes the transaction a covered transaction, as well as a brief description of the known end use(s) and end user(s) of the covered foreign person's technology, products, or services;
(11) A statement describing the attributes that cause the entity to be a covered foreign person, and any other relevant information regarding the covered foreign person and covered activity or activities;
(12) If a transaction involves a covered activity identified in § 850.217(a), (b), or (c), identification of the technology node(s) at which any applicable product is produced; and;
(13) If the notification is required under § 850.403:
(i) Identification of the fact or circumstance of which the U.S. person acquired knowledge post-transaction;
(ii) The date upon which the U.S. person acquired such knowledge;
(iii) A statement explaining why the U.S. person did not possess or obtain such knowledge at the time of the transaction; and
(iv) A description of any pre-transaction diligence undertaken by the U.S. person, including, as applicable, any steps described in § 850.104(c).
(c) The U.S. person shall maintain a copy of the notification filed and supporting documentation for a period of ten years from the date of the filing. Such supporting documentation shall include, as applicable, any pitch decks, marketing letters, and offering memorandums; transaction documents including side letters and investment agreements; and due diligence materials related to the transaction. The U.S. person shall make all supporting
(d) If the U.S. person does not provide responses to the information required in paragraph (b) of this section, the U.S. person shall provide sufficient explanation for why the information is unavailable or otherwise cannot be obtained and explain the U.S. person's efforts to obtain such information. If such information subsequently becomes available, the U.S. person shall provide such information to the Department of the Treasury promptly, and in no event later than 30 calendar days following the availability of such information.
A person who has made any representation, statement, or certification subject to this part shall inform the Department of the Treasury in writing promptly, and in no event later than 30 calendar days after learning of a material omission or inaccuracy in such representation, statement, or certification.
A transaction that would be either a prohibited transaction or a notifiable transaction if engaged in by a U.S. person but for this section is not a prohibited transaction or a notifiable transaction if the conditions set forth in this section are met. In that case, the transaction is an excepted transaction.
(a) The following transactions are excepted transactions:
(1) An investment by a U.S. person:
(i) In any publicly traded security, with “security” as defined in section 3(a)(10) of the Securities Exchange Act of 1934, as amended, at 15 U.S.C. 78c(a)(10), denominated in any currency, and that trades on a securities exchange or through the method of trading that is commonly referred to as “over-the-counter,” in any jurisdiction;
(ii) In a security issued by (1) any “investment company” as defined in section 3(a)(1) of the Investment Company Act of 1940, as amended, at 15 U.S.C. 80a-3(a)(1), that is registered with the U.S. Securities and Exchange Commission, such as index funds, mutual funds, or exchange traded funds, or (2) any company that has elected to be a business development company pursuant to section 54 of the Investment Company Act of 1940 (15 U.S.C. 8a-54); or any derivative thereon; or
(iii) Made as a limited partner or equivalent in a venture capital fund, private equity fund, fund of funds, or other pooled investment fund other than as described in paragraph (a)(1)(ii) of this section where:
(A) The limited partner's contribution is solely capital and the limited partner:
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(B)(
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(iii) Made as a limited partner or equivalent in a venture capital fund, private equity fund, fund of funds, or other pooled investment fund other than as described in paragraph (a)(1)(ii) of this section where the limited partner's committed capital is not more than $1,000,000, aggregated across any investment and co-investment vehicles that comprise the fund.
(2) Notwithstanding paragraph (a)(1) of this section, an investment is not an excepted transaction if it affords the U.S. person rights beyond standard minority shareholder protections with respect to the covered foreign person. Such protections include:
(i) The power to prevent the sale or pledge of all or substantially all of the assets of an entity or a voluntary filing for bankruptcy or liquidation;
(ii) The power to prevent an entity from entering into contracts with majority investors or their affiliates;
(iii) The power to prevent an entity from guaranteeing the obligations of majority investors or their affiliates;
(iv) The right to purchase an additional interest in an entity to prevent the dilution of an investor's pro rata interest in that entity in the event that the entity issues additional instruments conveying interests in the entity;
(v) The power to prevent the change of existing legal rights or preferences of the particular class of stock held by minority investors, as provided in the relevant corporate documents governing such stock; and
(vi) The power to prevent the amendment of the Articles of Incorporation, constituent agreement, or other organizational documents of an entity with respect to the matters described in paragraphs (a)(2)(i) through (v) of this section;
(b) The acquisition by a U.S. person of equity or other interests in an entity held by one or more persons of a country of concern;
(1) The U.S. person is acquiring all equity or other interests in such entity held by all persons of a country of concern; and
(2) Following such acquisition, the entity does not constitute a covered foreign person.
(c) A transaction that, but for this paragraph, would be a covered transaction between a U.S. person and its controlled foreign entity that supports ongoing operations or other activities that are not covered activities as defined in § 850.208;
(d) A transaction made after the effective date of this part pursuant to a binding, uncalled, capital commitment entered into before August 9, 2023; or
(e) The acquisition of a voting interest in a covered foreign person by a U.S. person upon default or other condition involving a loan or a similar financing arrangement, where the loan was made by a syndicate of banks in a loan participation where the U.S. person lender(s) in the syndicate:
(1) Cannot on its own initiate any action vis-à-vis the debtor; and
(2) Does not have a lead role in the syndicate; or
(f)(1) A transaction that is:
(i) With or involving a person of a country or territory outside of the United States designated by the Secretary, after taking into account whether the country or territory is
(ii) Of a type for which the Secretary has determined that the related national security concerns are likely to be adequately addressed by measures taken or that may be taken by the government of the relevant country or territory.
(2) Prior to making a designation or determination under this paragraph (f), the Secretary shall consult with the Secretary of State, the Secretary of Commerce, and, as appropriate, the heads of other relevant agencies.
(3) The Secretary's designations and determinations under paragraph (f) of this section shall be made available through public notice.
A limited partner's participation on an advisory board or a committee of an investment fund shall not constitute having the ability to undertake the actions referred to in Alternate 1 paragraphs (a)(1)(iii)(A)(
(a) The Secretary, in consultation with the Secretary of Commerce, the Secretary of State, and the heads of relevant agencies, as appropriate, may determine that a covered transaction is in the national interest of the United States and therefore is exempt from applicable provisions in Subparts C and D of this part (excluding §§ 850.406, 850.603, and 850.604). Such a determination may be made following a request by a U.S. person on its own behalf or on behalf of its controlled foreign entity.
(b) Any determination pursuant to paragraph (a) of this section will be based on a consideration of the totality of the relevant facts and circumstances and may be informed by, among other considerations, the transaction's effect on critical U.S. supply chain needs; domestic production needs in the United States for projected national defense requirements; United States' technological leadership globally in areas affecting U.S. national security; and impact on U.S. national security if the U.S. person is prohibited from undertaking the transaction.
(c) A U.S. person seeking a national interest exemption shall submit relevant information to the Department of the Treasury regarding the transaction and shall articulate the basis for the request, including the U.S. person's analysis of the transaction's potential impact on the national interest of the United States. The Department of the Treasury may request additional information that may include some or all of the information required under § 850.405.
(d) A determination that a covered transaction is exempt under this section may be subject to binding conditions.
(e) No determination pursuant to paragraph (a) of this section will be valid unless provided to the subject U.S. person in writing and signed by the Assistant Secretary or Deputy Assistant Secretary of the Treasury for Investment Security.
A process and related information for exemption requests will be made available on the Department of the Treasury's Outbound Investment Security Program website.
Conduct referred to in 50 U.S.C. 1702(b) shall not be regulated or prohibited, directly or indirectly, by this part.
The taking of any action prohibited by this part is a violation of this part.
Failure to take any action required by this part, and within the time frame and in the manner specified by this part, as applicable, is a violation of this part.
With respect to any information submission to or communication with the Department of the Treasury pursuant to any provision of this part, the making of any materially false or misleading representation, statement, or certification, or falsifying or concealing any material fact is a violation of this part.
(a) Any action on or after the effective date of this part that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in this part is prohibited.
(b) Any conspiracy formed to violate the prohibitions set forth in this part is prohibited.
(a) Section 206 of IEEPA applies to any person subject to the jurisdiction of the United States who violates, attempts to violate, conspires to violate, or causes a violation of any order, regulation, or prohibition issued by or pursuant to the direction or authorization of the Secretary pursuant to this part or otherwise under IEEPA.
(1) A civil penalty not to exceed the maximum amount set forth in section 206 of IEEPA may be imposed on any person who violates, attempts to violate, conspires to violate, or causes a violation of any order, regulation, or prohibition issued under IEEPA, including any provision of this part.
(2) A person who willfully commits, willfully attempts to commit, willfully conspires to commit, or aids or abets in the commission of a violation, attempt to violate, conspiracy to violate, or causing of a violation of any order, regulation, or prohibition issued under IEEPA, including any provision of this part, shall, upon conviction, be fined not more than $1,000,000, or if a natural person, be imprisoned for not more than 20 years, or both.
(b) The Secretary may refer potential criminal violations of the Order, or of this part, to the Attorney General.
(c) The civil penalties provided for in IEEPA are subject to adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended (Pub. L. 101-410, 28 U.S.C. 2461 note).
(d) The criminal penalties provided for in IEEPA are subject to adjustment pursuant to 18 U.S.C. 3571.
(e) The penalties available under this section are without prejudice to other penalties, civil or criminal, and forfeiture of property, available under other applicable law.
(f) Pursuant to 18 U.S.C. 1001, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully falsifies, conceals or covers up by any trick, scheme, or device a material fact; makes any materially false, fictitious, or fraudulent statement or representation; or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry shall be fined under title 18, United States Code, or imprisoned not more than 5 years, or both.
The imposition of a monetary penalty under this part creates a debt due to the U.S. Government. The Department of the Treasury may take action to collect the penalty assessed if not paid. In addition or instead, the matter may be
(a) The Secretary, in consultation with the heads of relevant agencies, as appropriate, may take any action authorized under IEEPA to nullify, void, or otherwise compel the divestment of any prohibited transaction entered into after the effective date of this part.
(b) The Secretary may refer any action taken under paragraph (a) of this section to the Attorney General to seek appropriate relief to enforce such action.
(a) Any person who has engaged in conduct that may constitute a violation of this part may submit a voluntary self-disclosure of that conduct to the Department of the Treasury.
(b) In determining the appropriate response to any violation, the Department of the Treasury will consider the submission and the timeliness of any voluntary self-disclosure.
(c) In assessing the timeliness of a voluntary self-disclosure, the Department of the Treasury will consider whether it has learned of the conduct prior to the voluntary self-disclosure. The Department of the Treasury may consider disclosure of a violation to another government agency other than the Department of the Treasury as a voluntary self-disclosure based on a case-by-case assessment.
(d) Notwithstanding the foregoing, identification to the Department of the Treasury of conduct that may constitute a violation of this part may not be assessed to be a voluntary self-disclosure in one or more of the following circumstances:
(1) A third party has provided a prior disclosure to the Department of the Treasury of the conduct or similar conduct related to the same pattern or practice, regardless of whether the disclosing person knew of the third party's prior disclosure;
(2) The disclosure includes materially false or misleading information;
(3) The disclosure, when considered along with supplemental information timely provided by the disclosing person, is materially incomplete;
(4) The disclosure is not self-initiated, including when the disclosure results from a suggestion or order of a federal or state agency or official;
(5) The disclosure is a response to an administrative subpoena or other inquiry from the Department of the Treasury or another government agency;
(6) The disclosure is made about the conduct of an entity by an individual in such entity without the authorization of such entity's senior management; or
(7) The filing is made pursuant to a required notification under this part, including § 850.403 or § 850.406.
(e) A voluntary self-disclosure to the Department of the Treasury must take the form of a written notice describing the conduct that may constitute a violation and each of the persons involved. A voluntary self-disclosure must include, or be followed within a reasonable period of time by, a report of sufficient detail to afford a complete understanding of the conduct that may constitute the violation. A person making a voluntary self-disclosure must respond in a timely manner to any follow-up inquiries by the Department of the Treasury.
(a) Except to the extent required by law or otherwise provided in paragraphs (b) and (c) of this section, information or documentary materials not otherwise publicly available that are submitted to the Department of the Treasury under this part shall not be disclosed to the public.
(b) Notwithstanding paragraph (a) of this section, except to the extent prohibited by law, the Department of the Treasury may disclose information or documentary materials that are not otherwise publicly available, subject to appropriate confidentiality and classification requirements, when such information or documentary materials are:
(1) Relevant to any judicial or administrative action or proceeding;
(2) Provided to Congress or to any duly authorized committee or subcommittee of Congress; or
(3) Provided to any domestic governmental entity, or to any foreign governmental entity of a United States partner or ally, where the information or documentary materials are important to the national security analysis or actions of such governmental entity or the Department of the Treasury.
(c) Notwithstanding paragraph (a) of this section, the Department of the Treasury may disclose to third parties information or documentary materials that are not otherwise publicly available when the person who submitted or filed the information or documentary materials has consented to its disclosure to such third parties.
(d) The Department of the Treasury may use the information gathered pursuant to this part to fulfill its obligations under the Order, which may include publication of anonymized data.
All materials or information filed with the Department of the Treasury under this part shall be submitted in English. If supplementary or additional materials were originally written in a foreign language, they shall be submitted in their original language. Where English versions of those documents exist, they shall also be submitted.
Any action that the Secretary is authorized to take pursuant to the Order and any further executive orders relating to the national emergency declared in the Order may be taken by the Assistant Secretary of the Treasury for Investment Security or their designee or by any other person to whom the Secretary has delegated the authority so to act, as appropriate.
(a) Except as otherwise provided by law, and in consultation with the Secretary of Commerce and, as appropriate, the heads of other relevant agencies, the Secretary may amend, modify, or revoke provisions of this part at any time.
(b) Except as otherwise provided by law, any instructions, orders, forms, regulations, or rulings issued pursuant to this part may be amended, modified, or revoked at any time.
(c) Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such instructions, orders, forms, regulations, or rulings pursuant to this part continue and may be enforced as if such amendment, modification, or revocation had not been made.
The provisions of this part are separate and severable from one another. If any of the provisions of this part, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or application of such provisions to other persons or circumstances that can be given effect
(a) Any person is required to furnish under oath, in the form of reports or otherwise, at any time as may be required by the Department of the Treasury, complete information regarding any act or transaction subject to the provisions of this part, regardless of whether such act or transaction is effected pursuant to a national interest exemption under § 850.502. Except as provided otherwise, the Department of the Treasury may, through any person or agency, conduct investigations, hold hearings, administer oaths, examine witnesses, receive evidence, take depositions, and require by subpoena the attendance and testimony of witnesses and the production of any books, contracts, letters, papers, and other hard copy or electronic documents relating to any matter under investigation, regardless of whether any report has been required or filed under this section.
(b) For purposes of paragraph (a) of this section, the term
(c) Persons providing documents to the Department of the Treasury pursuant to this section must do so in a usable format agreed upon by the Department of the Treasury.