Agricultural Marketing Service
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Engineers Corps
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Land Management Bureau
National Park Service
Drug Enforcement Administration
Occupational Safety and Health Administration
National Endowment for the Humanities
Federal Aviation Administration
Federal Highway Administration
Great Lakes St. Lawrence Seaway Development Corporation
Internal Revenue Service
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Agricultural Marketing Service, Department of Agriculture (USDA).
Final rule.
This final rule implements a recommendation from the Hazelnut Marketing Board (Board) to decrease the assessment rate established for the 2023-2024 marketing year and subsequent marketing years. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
This rule is effective April 5, 2024.
Virginia Tjemsland, Marketing Specialist, or Barry Broadbent, Acting Chief, West Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2282, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Market Development Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-8085, or Email:
This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement No. 115 and Order No. 982, both as amended (7 CFR part 982), regulating the handling of hazelnuts grown in Oregon and Washington. Part 982 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Board locally administers the Order and is composed of growers and handlers of hazelnuts operating within the area of production, and a public member.
The Agricultural Marketing Service (AMS) is issuing this final rule in conformance with Executive Orders 12866, 13563, and 14094. 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 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 supplements and reaffirms Executive Orders 12866 and 13563 and directs agencies to conduct proactive outreach to engage interested and affected parties through a variety of means, such as through field offices, and alternative platforms and media. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866, 13563, and 14094 review.
This final rule has been reviewed under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this rule is unlikely to have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, hazelnut handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate will be applicable to all assessable hazelnuts for the 2023-2024 marketing year, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
Section 982.61 provides authority for the Board, with the approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. Members are familiar with the Board's needs and with the costs of goods and services in their local area and are, thus, in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2017-2018 marketing year and subsequent marketing years, the Board recommended, and AMS approved, an assessment rate of $12 per ton (equivalent to $0.006 per pound) of hazelnuts. That rate continues in effect from marketing year to marketing year until modified, suspended, or terminated by AMS upon recommendation and information submitted by the Board or other information available to AMS. This final rule will decrease the assessment rate from $0.006 per pound to $0.005 per pound for the 2023-2024 marketing year and subsequent marketing years.
The Board met on June 29, 2023, and recommended 2023-2024 marketing year expenditures of $1,815,000 and an assessment rate of $10 per ton (the equivalent of $0.005 per pound) of hazelnuts handled for the 2023-2024
The expenditures totaling $1,815,000 recommended by the Board for the 2023-2024 marketing year include $670,000 for promotional activities, $300,000 for contingency/undesignated, $100,000 for marketing research, $100,000 for research endowment, $378,000 for administrative activities, and $267,000 for miscellaneous expenses. By comparison, budgeted expenditures for the 2022-2023 marketing year for promotional activities, contingency, marketing research, research endowment, administrative activities, and miscellaneous expenses were $1,251,200, $200,000, $150,000, $100,000, $347,350, and $330,000, respectively. The Board's 2023-2024 marketing year budget was reduced to account for generally lower commodity prices and decreased industry revenue.
The expected 170 million pounds of assessable hazelnuts from the 2023 crop will generate $850,000 in assessment revenue at the assessment rate established herein (170 million pounds multiplied by $0.005 assessment rate). The remaining $965,000 needed to cover budgeted expenditures will come from new grant funds and reserve funds carried over from previous marketing years. The Board anticipates $495,000 in Federal grants administered by USDA's Foreign Agricultural Service.
The Board derived the recommended assessment rate by considering anticipated expenses, an estimated 2023 crop volume of 170 million pounds of assessable hazelnuts, grants that have been awarded, and the amount of funds available in the authorized reserve. Income derived from handler assessments ($850,000), and funds from other sources ($965,000), is expected to be adequate to cover budgeted expenses ($1,815,000).
The assessment rate established herein will continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Board or other available information.
Although this assessment rate will be in effect for an indefinite period, the Board will continue to meet prior to or during each marketing year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Board meetings are available from the Board or AMS. Board meetings are open to the public and interested persons may express their views at these meetings. AMS would evaluate Board recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Board's 2023-2024 marketing year budget, and those for subsequent marketing years, will be reviewed and, as appropriate, approved by AMS.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this final rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of typically small entities acting on their own behalf.
There are approximately 1,103 producers of hazelnuts in the production area and 14 handlers subject to regulation under the Order. At the time this analysis was prepared, small agricultural producers of hazelnuts were defined by the Small Business Administration (SBA) as those having annual receipts equal to or less than $3,750,000 (North American Industry Classification System code 111335), and small agricultural service firms were defined as those whose annual receipts are equal to or less than $34,000,000 (North American Industry Classification System code 115114) (13 CFR 121.201).
According to the National Agricultural Statistics Service (NASS), the average producer price received for hazelnuts sold in Oregon specifically in 2022 was $1,300 per ton. Total production of hazelnuts for the 2022 season was reported by the NASS to be 68,000 tons. Using the average price and production data from the 2022 crop year, the most recent year for which there is NASS data available, the total 2022 crop value of hazelnuts could be estimated to be $88,400,000 (68,000 tons times $1,300 per ton). Dividing the crop value by the estimated number of producers (1,103) yields estimated average receipts per hazelnut producer of $80,145, which is well below the SBA threshold for small producers.
In addition, according to AMS Market News data, the reported average 2021-2022 marketing year shipping point price for hazelnuts was $126.82 per 50-pound container, or $2.54 per pound ($126.82 per 50-pound container divided by 50 pounds). Multiplying the 2022 hazelnut production of 136,000,000 pounds (68,000 tons) by the estimated average price per pound of $2.54 equals $345,440,000 of estimated handler receipts. Dividing this figure by the 14 regulated handlers yields estimated average annual handler receipts of approximately $24,674,286 ($345,440,000 divided by 14 handlers), which is below the SBA threshold for small agricultural service firms. Therefore, using the above data, most of the producers and handlers of hazelnuts may be classified as small entities.
This rule will decrease the assessment rate collected from handlers for the 2023-2024 marketing year and subsequent marketing years from $0.006 to $0.005 per pound of assessable hazelnuts. The Board unanimously recommended 2023-2024 marketing year expenditures of $1,815,000 and an assessment rate of $10 per ton ($0.005 per pound) of assessable hazelnuts. The assessment rate of $0.005 per pound is $.001 lower than the current rate. The Board expects the industry to handle 85,000 tons (170 million pounds) of assessable hazelnuts during the 2023-2024 marketing year.
Thus, at the $0.005 per pound rate, the Board anticipates $850,000 in assessment income (170 million pounds multiplied by $0.005 per pound). The Board also expects to use grant funds
The major expenditures recommended by the Board for the 2023-2024 marketing year include $670,000 for promotional activities, $300,000 for contingency/undesignated, $100,000 for marketing research, $100,000 for research endowment, $378,000 for administrative activities, and $267,000 for miscellaneous expenses. Budgeted expenditures for the 2022-2023 marketing year were $1,251,200 for promotional activities, $200,000 for contingency/undesignated, $150,000 for marketing research, $100,000 for research endowment, $347,350 for administrative activities, and $330,000 for miscellaneous, respectively.
The Board's 2023-2024 marketing year budget was reduced $563,550 from the prior year's budget to account for generally lower commodity prices and decreased industry revenue. In addition, the Board recommended decreasing the assessment rate to reduce the financial burden on the handlers and growers during the current environment of depressed prices. In recent years, the Board has utilized reserve funds to partially fund its budgeted expenditures. The Board's 2023-2024 marketing year budget again utilizes funds from the financial reserve to subsidize expenditures, but at a lower amount than in previous years. With this action, the Board's reserve balance will be maintained at a level that the Board believes is appropriate and is compliant with the provisions of the Order.
Prior to arriving at the budget and assessment rate, the Board discussed various alternatives, including maintaining the current assessment rate of $0.006 per pound and reducing the assessment rate to $0.0055 per pound ($11 per ton). However, the Board determined that the recommended assessment rate will be able to reduce the financial burden on the industry and still fund most of the Board's budgeted expenses without drawing down reserves at an unsustainable rate. The assessment rate of $0.005 per pound of hazelnuts was derived by considering anticipated expenses, the projected volume of assessable hazelnuts, the projected monetary balance held in reserve, and additional pertinent factors.
A review of NASS information indicates that the average producer price for the 2022 crop year was $0.65 per pound ($1,300 per ton). Further, NASS reported the quantity of hazelnuts harvested in the 2022 crop year was 136 million pounds (68,000 tons), which yields estimated total producer revenue for 2022 of $88,400,000 ($0.65 per pound multiplied by 136 million pounds). Therefore, utilizing the assessment rate of $0.005 per pound, the estimated assessment revenue as a percentage of total producer revenue will be approximately 0.77 percent ($0.005 per pound multiplied by 136 million pounds divided by $88,400,000 and multiplied by 100).
This action will decrease the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to growers. However, these costs are expected to be offset by the benefits derived by the operation of the Order.
The Board's meetings are widely publicized throughout the production area. The hazelnut industry and all interested persons are invited to attend the meetings and participate in Board deliberations on all issues. Like all Board meetings, the June 29, 2023, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.
In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. No changes in those requirements will be necessary as a result of this rule. Should any changes become necessary, they would be submitted to OMB for approval.
This final rule will not impose any additional reporting or recordkeeping requirements on either small or large hazelnut handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
A proposed rulemaking concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendations submitted by the Board and other available information, AMS has determined that this rule tends to effectuate the declared policy of the Act.
Marketing agreements, Nuts, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR part 982 as follows:
7 U.S.C. 601-674.
On and after July 1, 2023, an assessment rate of $0.005 per pound is established for Oregon and Washington hazelnuts.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Final rule.
This document adopts as a final rule, with no changes, interim amendments to the U.S. Customs and Border Protection (CBP) regulations that were published in the
This rule is effective as of March 6, 2024.
Kellee Gross, Branch Chief, Trade Processes Branch, Office of Trade, 202-815-1699,
Sections 13801-13808 of the Tax Cuts and Jobs Act of 2017 (Pub. L. 115-97), signed December 22, 2017, commonly referred to as the Craft Beverage Modernization Act (CBMA), amended the Internal Revenue Code for two calendar years with respect to the tax treatment of imported alcohol, including beer, wine, and distilled spirits. The CBMA authorized reduced tax rates and tax credits for imported alcohol and permitted the refund of taxes paid prior to assigning a reduced tax rate or tax credit. On August 16, 2018, U.S. Customs and Border Protection (CBP) published an interim final rule, CBP Decision (CBP Dec.) 18-09, in the
On December 19, 2019, the Further Consolidated Appropriations Act was signed, which extended the relevant provisions of the CBMA through calendar year 2020.
On December 30, 2022, CBP published an interim final rule, CBP Dec. 22-26, in the
CBP is adopting as final the interim rule, CBP Dec. 22-26, published in the
Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, 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. This final rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, the Office of Management and Budget (OMB) has not reviewed this regulation.
The Regulatory Flexibility Act (5 U.S.C. 601
The provisions of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this final rule, because this final rule does not trigger any new or revised recordkeeping or reporting.
This final rule is being issued by CBP in accordance with section 0.1(a)(1) of the CBP regulations (19 CFR 0.1(a)(1)) pertaining to the authority of the Secretary of the Treasury (or the Secretary's delegate) to approve regulations related to certain customs revenue functions. The Senior Official Performing the Duties of the Commissioner Troy A. Miller, having reviewed and approved this document, has delegated the authority to electronically sign the document to the Director (or Acting Director, if applicable) of the Regulations and Disclosure Law Division of CBP, for purposes of publication in the
Accounting, Claims, Harbors, Reporting and recordkeeping requirements, Taxes.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the Committee) to the list of standing committees.
This rule is effective March 6, 2024.
Moon Choi, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993, 301-796-2894,
The Committee was established on December 12, 2023, and notice of establishment was published in the
The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug and biologic products for use in the treatment of genetic metabolic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs (the Commissioner).
The Committee shall consist of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of medical genetics, manifestations of inborn errors of metabolism, small population trial design, translational science, pediatrics, epidemiology, or statistics and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this Committee will serve either as special government employees or non-voting representatives. Federal members will serve as regular government employees or ex 1652fficious. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.
The Committee name and function have been established with the establishment of the Committee charter. The change became effective December 12, 2023. Therefore, the Agency is amending § 14.100 (21 CFR 14.100) to add the Committee name and function to its current list as set forth in the regulatory text of this document.
Under 5 U.S.C. 553(b)(4)(B) and (d) and 21 CFR 10.40(d) and ©, the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule is merely codifying the addition of the name and function of the GeMDAC to the list of standing FDA advisory committees. The establishment of the Committee is already effective, and the name and function that will be added to § 14.100 reflect the Committee charter. The Agency is amending § 14.100(c)(18) as set forth in the regulatory text of this document.
Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:
5 U.S.C. 1001
(c) * * *
(18)
(i) Date Established: December 12, 2023.
(ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug and biologic products for use in the treatment of genetic metabolic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.
Great Lakes St. Lawrence Seaway Development Corporation, DOT.
Final rule.
The Great Lakes St. Lawrence Seaway Development Corporation (GLS) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the GLS is amending the joint regulations by updating the regulations and rules in various categories. These changes are to clarify existing requirements in the regulations.
This rule is effective on March 22, 2024.
Carrie Mann Lavigne, Chief Counsel, Great Lakes St. Lawrence Seaway Development Corporation, 180 Andrews Street, Massena, New York 13662; (315) 764-3200.
The Great Lakes St. Lawrence Seaway Development Corporation (GLS) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the GLS is amending the joint regulations by updating the Regulations and Rules in various categories. The changes update the following sections of the Regulations and Rules: Condition of Vessels, Seaway Navigation, Radio Communications, and Information and Reports. These changes are to clarify existing requirements in the regulations.
The joint regulations will become effective in Canada on March 22, 2024. For consistency, because these are joint regulations under international agreement, and to avoid confusion among users of the Seaway, the GLS finds that there is good cause to make the U.S. version of the amendments effective on the same date.
This regulation involves a foreign affairs function of the United States and therefore, Executive Order 12866 does not apply and evaluation under the Department of Transportation's Regulatory Policies and Procedures is not required.
I certify that this regulation will not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Regulations and Rules primarily relate to commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels.
This regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321,
The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and has determined that this proposal does not have sufficient federalism implications to warrant a Federalism Assessment.
The Corporation has analyzed this rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives.
This regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review.
Hazardous materials transportation, Navigation (water), Penalties, Radio, Reporting and recordkeeping requirements, Vessels, Waterways.
Accordingly, the Great Lakes St. Lawrence Seaway Development Corporation is amending 33 CFR part 401 as follows:
33 U.S.C. 983(a) and 984(a)(4), as amended; 49 CFR 1.101, unless otherwise noted.
(a) Vessels of more than 50 m in overall length and a freeboard of 2m or more shall either be equipped with landing booms or make their own provisions for tie-up at the approach walls.
(b) For vessels with landing booms:
(1) Vessel must be equipped with an adequate landing boom on each side;
(2) Landing booms must be in compliance with applicable regulations;
(3) Vessel's crews shall be adequately trained in the use of landing booms for the purpose of landing crew ashore.
(4) Vessel must have onboard for inspection the following documents:
(i) A copy of the test certificates for each of the landing booms from either a classification society or a third party, dated within 5 years;
(ii) Documents to demonstrate appropriate training;
(iii) Documented tests and maintenance records of landing boom equipment.
(c) At the U.S. Locks, vessels not equipped with or not using landing booms may be tied up at the approach walls based on Lock personnel availability.
(d) At the Canadian Locks, vessels not equipped with or not using landing booms should make alternate arrangements for tie-up at approach walls prior to commencing transit of the Seaway. Example: ship contract in place with a 3rd party service provider where ship is responsible for contacting provider.
(1) Vessels that do not have a tie-up strategy in place for the lock approach walls may be delayed and/or put to anchor until such time that the traffic pattern can accommodate their transit.
(2) [Reserved]
(a) * * *
(1) All communications shall be on the applicable VHF frequency. The use of personal electronic devices for communication between vessels or with traffic control should be limited to necessity.
(2) Please note that communications into the Traffic Control Center may be recorded for quality assurance and training purposes.
(a) Every vessel not equipped with containers for ordure shall be equipped with a sewage disposal system enabling compliance with the Vessel Pollution and Dangerous Chemicals regulations (Canada), the U.S. Clean Water Act, and the U.S. Rivers and Harbors Act of 1899, and amendments thereto.
(b) * * *
(2) Retained on board in covered, leak-proof containers, until such time as it can be disposed of in accordance with the provisions of the Vessel Pollution and Dangerous Chemicals regulations (Canada), the U.S. Clean Water Act and the U.S. Rivers and Harbors Act of 1899, and amendments thereto.
(b) * * *
(4) International Maritime Organization (IMO) Guidelines for Installation of Shipborne Automatic Identification System (AIS), NAV 48/18, 6 January 2003, as amended, and, for ocean vessels only, with a pilot plug, as specified in Section 3.2 of those Guidelines, installed close to the primary conning position in the navigation bridge and a power source accessible for the pilot's laptop computer; and
(b) The draught of a vessel shall meet minimum draft requirements as defined at inspection on the Enhanced Ship Inspection form and not, in any case, exceed 79.2 dm or the maximum permissible draught designated in a Seaway Notice by the Manager and the Corporation for the part of the Seaway in which a vessel is passing.
(c) Any vessel will be permitted to load at an increased draught of not more than 7 cm above the maximum permissible draught in effect as prescribed under 401.29(b) if it is equipped with a Draught Information System (DIS) and meets the following:
(1) An operational Draught Information System (DIS) approved by a member of the International Association of Classification Societies (IACS) as compliant with the Implementation Specifications found at
(i) An operational AIS with accuracy approved by the Seaway; and
(ii) Up-to-date electronic charts; and
(iii) Up-to-date charts containing high resolution bathymetric data; and
(iv) Vessels must be equipped with a bow thruster and bow thruster must be operational.
(2) The DIS Tool Display shall be located as close to the primary conning position and be visible and legible.
(i) Verification document of the DIS must be kept on board the vessel at all times and made available for inspection;
(ii) DIS license to use the software must be valid;
(iii) A company letter attesting to officer training on use of the DIS must be kept on board and made available for inspection;
(iv) When transiting Seaway waters with the DIS, a trained officer on the use of the DIS must be on the bridge;
(v) Any vessel intending to use the DIS for the first time must notify the Manager or the Corporation in writing at least 24-hours prior to commencement of its initial transit in the System with the DIS in order to arrange for appropriate testing for approval to use the DIS;
(vi) Every navigation season, each vessel intending to use an approved DIS to transit the System must submit a completed confirmation checklist found at
(vii) If for any reason the DIS, AIS, or bow thruster becomes inoperable, malfunctions or is not used while the vessel is transiting at a draught greater than the maximum permissible draught prescribed under 401.29(b) in effect at the time, the vessel must notify the Manager or the Corporation immediately.
(a) The primary means of securing vessels in the locks is by way of the Hands-Free Mooring (HFM) system. Vessels being moored by HFM must have a minimum of one well rested crew member on deck during the lockage to assist the Bridge team.
(b) Single tugs, tug/barge combinations, and small vessels (less than 160m in overall length) that are not eligible to use HFM are to be processed without mooring lines at the Canadian Locks with the exception of upbound lockages at Locks 4, 5 and 6 in the Welland Canal.
(c) Vessels requiring the use of mooring lines shall be processed as follows:
(1) Mooring lines shall only be placed on mooring posts as directed by the officer in charge of the mooring operation.
(2) No winch from which a mooring line runs shall be operated until the officer in charge of a mooring operation has signaled that the line has been placed on a mooring post.
(3) Once the mooring lines are on the mooring posts, lines shall be kept slack until the “all clear” signal is given by the lock personnel. When casting off signal is received, mooring lines shall be kept slack until the “all clear” signal is given by the lock personnel.
(4) Vessels being moored by “Hands Free Mooring” system (HFM) or passing through a lock without the use of mooring lines shall have a minimum of one well rested crew member on deck during the lockage to assist the Bridge team.
(b) No vessel shall proceed out of a lock until the exit gates, ship arresters and the bridge, if any, are in a fully open position and the lock operator gives the “all clear” instruction.
(d) Persons intending on disembarking or boarding a vessel shall only do so after they have confirmed with the Captain that the vessel is fully secured in the lock with Hands-Free Mooring or with mooring lines.
(d) Every vessel intending to conduct a dive operation and/or Remotely Operated Vehicle (ROV) inspection at a dock, wharf or approach wall shall provide a 24-hour minimum notice of diving operations to the appropriate Seaway Traffic control Centre.
(a) USCG Advance Notice of Arrival—All foreign flagged ships of 300 GRT or above intending to transit the Seaway shall submit one completed United States Coast Guard (USCG) Electronic Notice of Arrival (ENOA) prior to entering at call in point 2 (CIP 2) as follows:
(1) If your voyage time to CIP 2 is 96 hours or more, you must submit an ENOA 96 hours before entering the Seaway at CIP 2.
(2) If your voyage time to CIP 2 is less than 96 hours, you must submit an ENOA before departure, but at least 24 hours before entering the Seaway at CIP 2.
(3) If there are changes to the ENOA, submit them as soon as practicable but at least 12 hours before entering the Seaway at CIP 2.
(4) The NOA must be provided electronically following the USCG National Vessel Movement Center's (NVMC) procedures (
(5) To complete the ENOA correctly for Seaway entry, select the following:
(i) “CIP 2” as the Arrival Port,
(ii) “Foreign to Saint Lawrence Seaway” as the Voyage Type, and
(iii) “Saint Lawrence Seaway Transit” as the Arrival State, City and Receiving Facility.
(b) Foreign Vessel Inspection program:
(1) Enhanced Ship Inspections (ESI)—physical vessel inspection: Foreign flagged vessels are subject to a Seaway inspection once every two navigation seasons. Agents must provide an initial notice of inspection 120 hours prior to the ship's arrival at CIP2. (to:
(2) Subject to satisfactory performance, a Self-Inspection may be permitted in the interim season. Vessel to complete a Foreign Self Inspection report and submit electronically to
(3) The ESI or self-inspection is required on the first transit of the navigation season.
(4) Inland self-inspection: Inland domestic vessels which are approved by the Seaway and are ISM certified and have a company quality management system, must submit the “Self-Inspection Report”, every 2 navigation seasons and not later than 30 days after “fit out”.
(5) Inland domestic vessels not participating in the “Self-Inspection Program” are subject to Seaway inspection prior to every transit of the Seaway.
(6) Tug/barge combinations not on the “Seaway Approved Tow” list are subject to Seaway inspection prior to every transit of the Seaway unless provided with a valid Inspection Report for a round trip transit.
(7) A tall vessel, passenger vessel, or vessel of an unusual design is subject to Seaway yearly inspection.
(d) any malfunction on the vessel of equipment and machinery that is noted as operational in the current “Enhanced Ship Inspection” or “Self Inspection” of the vessel;
Issued at Washington, DC, under authority delegated at 49 CFR part 1.101.
Great Lakes St. Lawrence Seaway Development Corporation.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve a revision to the Sacramento Metropolitan Air Quality Management District (SMAQMD) portion of the California State Implementation Plan (SIP). This revision concerns a rule submitted to address section 185 of the Clean Air Act (CAA or the Act).
This rule is effective April 5, 2024.
The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2023-0588. All documents in the docket are listed on the
Mae Wang, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105; phone: (415) 947-4137; email:
Throughout this document, “we,” “us” and “our” refer to the EPA.
On December 15, 2023 (88 FR 86870), the EPA proposed to approve the following rule into the California SIP.
We proposed to approve this rule because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.
The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.
No comments were submitted. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is approving SMAQMD Rule 307 into the California SIP. The March 23, 2023 version of Rule 307 will replace the
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of SMAQMD Rule 307, “Clean Air Act Penalty Fees,” amended on March 23, 2023, which addresses the CAA section 185 fee program requirements. The EPA has made, and will continue to make, these documents available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.S. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The State did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of Executive Order 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.
This action is subject to the Congressional Review Act, 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).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 6, 2024. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
For the reasons stated in the preamble, the Environmental Protection Agency amends part 52, chapter I, title 40 of the Code of Federal Regulations as follows:
42 U.S.C. 7401
(c) * * *
(308) * * *
(i) * * *
(C) * * *
(
(610) The following regulations were submitted electronically on May 11, 2023, by the Governor's designee as an attachment to a letter dated May 10, 2023.
(i)
(
(
(B) [Reserved]
(ii) [Reserved]
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2022-02-10, which applies to certain Dassault Aviation Model FALCON 7X, FALCON 900EX, and FALCON 2000EX airplanes. AD 2022-02-10 requires replacement of certain titanium screws. Since the FAA issued AD 2022-02-10, affected parts have been found in other areas of certain Falcon 7X airplanes as well as in additional Falcon 7X airplanes. This proposed AD would continue to require the actions in AD 2022-02-10, add other locations for screw replacement, and revise the applicability, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by April 22, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For the EASA AD identified in this NPRM, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
• You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
Tom Rodriguez, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 206-231-3226; 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 Tom Rodriguez, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 206-231-3226; email:
The FAA issued AD 2022-02-10, Amendment 39-21907 (87 FR 7025, February 8, 2022) (AD 2022-02-10), for certain Dassault Aviation Model FALCON 7X, FALCON 900EX, and FALCON 2000EX airplanes. AD 2022-02-10 was prompted by MCAI originated by EASA, which is the Technical Agent for the Member States of the European Union. EASA issued AD 2021-0047, dated February 16, 2021, to correct an unsafe condition.
AD 2022-02-10 requires replacement of certain titanium screws. The FAA issued AD 2022-02-10 to address failure of an affected screw installed in a critical location, possibly resulting in reduced structural integrity of the airplane. See the MCAI for additional background information.
Since the FAA issued AD 2022-02-10, EASA superseded EASA AD 2021-
The FAA is proposing this AD to address the unsafe condition on these products. You may examine the MCAI in the AD docket at
Although this proposed AD does not explicitly restate the requirements of AD 2022-02-10, this proposed AD would retain all of the requirements of AD 2022-02-10. Those requirements are referenced in EASA AD 2023-0207, which, in turn, is referenced in paragraph (g) of this proposed AD.
EASA AD 2023-0207 specifies procedures for replacing titanium screws.
Dassault Service Bulletin 7X-467, Revision 2, dated March 20, 2023, specifies procedures for additional work.
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country and is 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 referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain certain requirements of AD 2022-02-10. This proposed AD would require accomplishing the actions specified in EASA AD 2023-0207 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2023-0207 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2023-0207 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2023-0207 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2023-0207. Service information required by EASA AD 2023-0207 for compliance will be available at
The FAA estimates that this AD, if adopted as proposed, would affect 44 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
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 April 22, 2024.
This AD replaces AD 2022-02-10, Amendment 39-21907 (87 FR 7025, February 8, 2022) (AD 2022-02-10).
This AD applies to Dassault Aviation airplanes identified in paragraphs (c)(1) through (3) of this AD, certificated in any category, as identified in European Union Aviation Safety Agency (EASA) AD 2023-0207, dated November 21, 2023 (EASA AD 2023-0207).
(1) Model FALCON 7X airplanes.
(2) Model FALCON 900EX airplanes.
(3) Model FALCON 2000EX airplanes.
Air Transport Association (ATA) of America Code 51, Standard Practices/Structures.
This AD was prompted by a report of an improper heat treatment process applied during the manufacturing of certain Decomatic titanium screws, and by the determination that affected parts in additional areas on certain airplanes, as well as additional airplanes, are subject to the unsafe condition. The FAA is issuing this AD to address failure of an affected screw installed in a critical location, possibly resulting in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2023-0207.
(1) Where EASA AD 2023-0207 refers to its effective date, this AD requires using the effective date of this AD.
(2) This AD does not adopt the “Remarks” section of EASA AD 2023-0207.
(3) Where Ref Publications specifies “Dassault SB 7X-467 original issue dated 16 November 2020, Rev. 1 dated 12 December 2022 or Rev. 2 dated 20 March 2023,” this AD requires replacing those words with “Dassault Service Bulletin 7X-467, Revision 2, dated March 20, 2023.”
For Model FALCON 7X airplanes: This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Dassault Service Bulletin 7X-467, dated November 16, 2020, provided the additional work specified in Dassault Service Bulletin 7X-467, Revision 2, dated March 20, 2023, is accomplished within the applicable compliance time specified in EASA AD 2023-0207.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Tom Rodriguez, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 206-231-3226; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) European Union Aviation Safety Agency (EASA) AD 2023-0207, dated November 21, 2023.
(ii) Dassault Service Bulletin 7X-467, Revision 2, dated March 20, 2023.
(3) For EASA AD 2023-0207, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(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
Environmental Protection Agency (EPA).
Proposed rule; extension of comment period.
The Environmental Protection Agency (EPA) is extending, until March 26, 2024, the comment period for the proposed rule published in the
The public comment period for the proposed rule published in the
You may send comments, identified by Docket ID No. EPA-HQ-OLEM-2023-0085, by any of the following methods:
•
•
•
Submit your comments, identified by Docket ID No. EPA-HQ-RCRA-2023-0085, at
Barbara Foster, Program Information and Implementation Division, Office of Resource Conservation and Recovery (5303T)) Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460, 202-566-0382,
On February 8, 2024, the Agency published in the
Second, this proposed rule would add RCRA sections 3004(u) and (v) and 3008(h) to the statutory authorities identified in § 261.1(b)(2). That section provides that the statutory definitions of solid and hazardous waste govern the scope of EPA's authority under certain sections of RCRA, not the more limited 40 CFR part 261 regulatory definitions. These revisions provide notice of and codify the Agency's interpretation of the statute—that it provides authority to address releases from solid waste management units of all substances that meet the definition of hazardous waste under the statute.
Following publication of the proposed rule, several members of the public requested that the Agency extend the comment period.
In response to these requests, the Agency is extending the comment period for 15 days, until March 26, 2024. EPA does not want to unnecessarily delay this rulemaking and believes that this 15-day extension provides more than adequate time for reviewers to review the proposed rule and to submit comments given the very narrow scope of the rulemaking, and the limited amount of material reviewers need to review.
U.S. Agency for International Development (USAID).
Notice of information collection; request for comment.
In accordance with the Information Collection Review procedures of the Paperwork Reduction Act of 1995 (PRA), the United States Agency for International Development (USAID), is seeking comment on the proposed Generic Clearance for the Collection of Qualitative Customer Feedback on Agency Service Delivery. The Agency will use surveys and forms for routine customer feedback to collect, analyze, and interpret information gathered through this generic clearance to identify strengths and weaknesses of the current services, information, and to make improvements in customer service.
All comments should be submitted within 30 calendar days from the date of this publication.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Requests for additional information should be directed to Kelly Hamilton at 202-921-5016,
Pursuant to the PRA, the Agency is publishing this Notice to inform the public that the Agency will submit this proposed collection to the Office of Management and Budget (OMB) for approval. The Agency previously published this proposed information collection in the
The Agency will collect, analyze, and interpret information gathered through this generic clearance to identify strengths and weaknesses of the current services, information, and make improvements in service delivery based on feedback. The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:
• Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency (if released, procedures outlined in Question 16 will be followed);
• Information gathered will not be used for the purpose of substantially informing influential policy decisions;
• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study;
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are non-controversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; and
• With the exception of information needed to provide remunerations for participants of focus groups and cognitive laboratory studies, personally identifiable information (PII) is collected only to the extent necessary and is not retained.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
The projected average annual burden estimates for the next three years are listed below. The burdens have been increased from the 60-day notice amounts due to internal agency discussions on expected needs.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding: whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to 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 regarding this information collection received by April 5, 2024 will be considered. 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
Failure to comply with the requirements may result in the withholding of a recipient institution's formula funds and redistribution of its share of formula funds to other eligible institutions.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the City of Birmingham, grantee of FTZ 98, requesting an expansion of Subzone 98D for the facility of Hyster-Yale Group, Inc. (Hyster-Yale), located in Sulligent, Alabama. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on March 1, 2024.
The application requests authority to expand Subzone 98D to include the following new site: Site 3 (6.2 acres) is located at 7862 Highway 278, Sulligent, Alabama. No authorization for additional production activity has been requested at this time.
In accordance with the FTZ Board's regulations, Kolade Osho of the FTZ Staff is designated examiner to review the application and make recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary and sent to:
A copy of the application will be available for public inspection in the “Online FTZ Information Section” section of the FTZ Board's website, which is accessible via
For further information, contact Kolade Osho at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that certain producers/exporters subject to this administrative review did not make sales of subject merchandise at less than normal value (NV) during the period of review (POR) March 1, 2022, through February 28, 2023. Commerce is also rescinding the review, in part, with respect to 28 respondents. We invite interested parties to comment on these preliminary results.
Applicable March 6, 2024.
Jacob Keller or Thomas Schauer, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4849 or (202) 482-0410, respectively.
On March 11, 1986, Commerce published in the
A list of topics discussed in the Preliminary Decision Memorandum is attached in Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
The products covered by the
Pursuant to 19 CFR 351.213(d)(3), Commerce will rescind an administrative review when there are no reviewable suspended entries. Based on our analysis of U.S. Customs and Border Protection (CBP) information, we preliminarily determine that 28 companies had no entries of subject merchandise during the POR. On January 16, 2024, we notified parties of our intent to rescind this administrative review with respect to the 28 companies listed in Appendix II that had no reviewable suspended entries during the POR.
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 NV in accordance with sections 772 and 773 of the Act, respectively. For a complete description of the methodology underlying our conclusions,
Commerce preliminarily determines that the following estimated weighted-average dumping margins exist for the period March 1, 2022, through February 28, 2023:
Upon completion of the final results, Commerce shall determine and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
For entries of subject merchandise during the POR produced by Saha Thai or TPP for which they did not know that the merchandise was destined to the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
For the companies for which this review is rescinded with these preliminary results, we will instruct CBP to assess antidumping duties on all appropriate entries at a rate equal to the
The final results of this administrative 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 duties, where applicable.
The following cash deposit requirements will be effective upon publication in the
We intend to disclose the calculations performed for these preliminary results to interested parties within five 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 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. 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 case and rebuttal briefs.
All submissions, including case and rebuttal briefs, as well as hearing requests, should be filed using 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, not later than 120 days after the date of publication of this notice in the
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 review period. 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.
We are 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) and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this expedited sunset review, the U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on clad steel plate from Japan would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Expedited Sunset Review” section of this notice.
Applicable March 6, 2024.
Genevieve Coen, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3251.
On July 2, 1996, Commerce published in the
Commerce received a timely, adequate substantive response to the
On December 21, 2023, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from other interested parties.
The product covered by the
All issues raised in this sunset review are addressed in the Issues and Decision Memorandum, including the likelihood of continuation or recurrence of dumping and the magnitude of the margin of dumping likely to prevail if the
Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the
This notice serves as the only reminder to interested parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. 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 subject to sanction.
We are issuing and publishing the results in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
1. Likelihood of Continuation or Recurrence of Dumping
2. Magnitude of the Margin of Dumping Likely to Prevail
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that seamless carbon and alloy steel standard, line, and pressure pipe (seamless pipe) from Ukraine was sold at prices below normal value during the period of review (POR) February 10, 2021, through July 31, 2022.
Applicable March 6, 2024.
Reginald Anadio, 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) 482-3166.
On September 7, 2023, Commerce published the
The merchandise covered by the scope of the
All issues raised in Interpipe's case brief and Vallourec's rebuttal brief are addressed in the Issues and Decision Memorandum. A list of these issues is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
We determine that the following weighted-average dumping margin exists for the period February 10, 2021, through July 31, 2022:
Because Commerce made no changes to the
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with these final results of review.
In accordance with Commerce's “automatic assessment” practice, we will instruct CBP to liquidate POR entries of subject merchandise which Interpipe produced and sold but did not know was destined for the United States, at the all-others rate (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of this notice 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 this notice in the
This notice 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 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 duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under 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 the terms of an APO is a sanctionable violation.
We are issuing and publishing these final results of review in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(5).
Comment: Whether to Grant Interpipe a Constructed Export Price (CEP) Offset
National Institute of Standards and Technology, Department of Commerce.
Notice and request for comments.
This notice advises the public that the National Institute of Standards and Technology (NIST) is seeking comments for the proposed revision of Voluntary Product Standard (PS) 20-20, “American Softwood Lumber Standard.” This standard, prepared by the American Lumber Standard Committee, serves the procurement and regulatory needs of numerous Federal, State, and local government agencies by providing for uniform, industry-wide grade-marking and inspection requirements for softwood lumber. The implementation of the standard also allows for uniform labeling and auditing of treated wood and, through a Memorandum of Understanding with the U.S. Department of Agriculture, labeling and auditing of wood packaging materials for international trade. As part of a five-year review process, NIST is seeking public comment and invites interested parties to review the revised standard and submit comments.
Written comments regarding the proposed revision, PS 20-25, should be submitted to the Standards Coordination Office, NIST, no later than April 22, 2024.
An electronic copy (in PDF) of the current standard, PS 20-20, can be obtained at the following website
Nathalie Rioux, Standards Coordination Office, National Institute of Standards and Technology, email:
Under Department of Commerce regulations codified in title 15, Code of Federal Regulations, part 10,
Voluntary Product Standard (PS) 20-20 establishes standard sizes and requirements for developing and coordinating the lumber grades of the various species of lumber, the assignment of design values, and the preparation of grading rules applicable to each species. Its provisions include implementation of the standard through an accreditation and certification program; establishment of principal trade classifications and lumber sizes for yard, structural, and factory/shop use; classification, measurement, grading, and grade-marking of lumber; definitions of terms and procedures to provide a basis for the use of uniform methods in the grading inspection, measurement, and description of softwood lumber; commercial names of the principal softwood species; definitions of terms used in describing standard grades of lumber; and commonly used industry abbreviations. The standard also includes the organization and functions of the American Lumber Standard Committee, the Board of Review, and the National Grading Rule Committee.
All public comments will be reviewed and considered. All comments, including attachments will be accepted in Microsoft word, or Adobe PDF formats. Comments containing references, studies, research, and other empirical data that are not widely published should include copies or electronic links of the referenced materials.
All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. NIST reserves the right to publish comments publicly, unedited and in their entirety. Sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, should not be included. Comments will not be edited to remove any identifying or contact information. Do not submit confidential business information, or otherwise sensitive or protected information. Comments that contain profanity, vulgarity, threats, or other inappropriate language or content will not be considered.
Written comments should be submitted in accordance with the
National Institute of Standards and Technology (NIST).
Notice of open meeting.
The Internet of Things (IoT) Advisory Board will meet Tuesday, April 2 and Wednesday, April 3, 2024 from 11 a.m. until 5 p.m., eastern time. Both sessions will be open to the public.
The Internet of Things (IoT) Advisory Board will meet Tuesday, April 2 and Wednesday, April 3, 2024 from 11a.m. until 5 p.m., eastern time.
The meeting will be virtual via Webex webcast hosted by the National Cybersecurity Center of Excellence (NCCoE) at NIST. Please note registration instructions under the
Barbara Cuthill, Information Technology Laboratory, National Institute of Standards and Technology, Telephone: (301) 975-3273, Email address:
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. 1001
The agenda for the April, 2024 meeting is expected to focus on finalizing the IoT Advisory Board's report for the IoT Federal Working Group and the recommendations in that report.
The recommendations and discussions are expected to focus on the specific focus areas for the report cited in the legislation and the charter:
• Smart traffic and transit technologies
• Augmented logistics and supply chains
• Sustainable infrastructure
• Precision agriculture
• Environmental monitoring
• Public safety
• Health care
In addition, the IoT Advisory Board may discuss other elements that the legislation called for in the report:
• whether adequate spectrum is available to support the growing Internet of Things and what legal or regulatory barriers may exist to providing any spectrum needed in the future;
• policies, programs, or multi-stakeholder activities that—
○ promote or are related to the privacy of individuals who use or are affected by the Internet of Things;
○ may enhance the security of the Internet of Things, including the security of critical infrastructure;
○ may protect users of the Internet of Things; and
○ may encourage coordination among Federal agencies with jurisdiction over the Internet of Things
Note that agenda items may change without notice. The final agendas will be posted on the IoT Advisory Board web page:
Each IoT Advisory Board meeting agenda will include a period, not to exceed sixty minutes, for oral presentation of comments from the public. Oral presentation of comments from the public during this sixty-minute period will be accommodated on a first-come, first-served basis and limited to five minutes per person for oral presentation if requested by the commenter.
Members of the public who wish to expand upon their submitted comments, those who had wished to present comments orally but could not be accommodated on the agenda, and those who were unable to attend the meeting via webinar, are invited to submit written statements. In addition, written statements are invited and may be submitted to the IoT Advisory Board at any time. All written statements should be directed to the IoT Advisory Board Secretariat, Information Technology Laboratory by email to:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of the SEDAR Steering Committee meeting.
The SEDAR Steering Committee will meet to discuss the SEDAR stock assessment process and assessment schedule. See
The SEDAR Steering Committee will meet Monday, March 25, 2024, from 1 p.m. until 6 p.m., eastern and from 9 a.m. until 3 p.m., eastern on Tuesday, March 26, 2024. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the SEDAR process. Such adjustments may result in the meeting being extended from or completed prior to the time established by this notice.
Julie A. Neer, SEDAR Program Manager, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
The SEDAR Steering Committee provides guidance and oversight of the SEDAR stock assessment program and manages assessment scheduling.
The items of discussion for this meeting are as follows:
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SEDAR office (see
The times and sequence specified in this agenda are subject to change.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments on proposed renewal incidental harassment authorization.
NMFS received a request from Turnagain Marine Construction (TMC) for the renewal of their currently active incidental harassment authorization (IHA) to take marine mammals incidental to the cruise dock construction project in Whittier, Alaska. TMC's activities consist of activities that are covered by the current authorization but will not be completed prior to its expiration. Pursuant to the Marine Mammal Protection Act (MMPA), prior to issuing the currently active IHA, NMFS requested comments on both the proposed IHA and the potential for renewing the initial authorization if certain requirements were satisfied. The renewal requirements have been satisfied, and NMFS is now providing an additional 15-day comment period to allow for any additional comments on the proposed renewal not previously provided during the initial 30-day comment period.
Comments and information must be received no later than March 21, 2024.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, and should be submitted via email to
Jenna Harlacher, Office of Protected Resources (OPR), NMFS, (301) 427-8401. Electronic copies of the original application, renewal request, and supporting documents (including NMFS
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses
NMFS' regulations implementing the MMPA at 50 CFR 216.107(e) indicate that IHAs may be renewed for additional periods of time not to exceed one year for each reauthorization. In the notice of proposed IHA for the initial IHA, NMFS described the circumstances under which we would consider issuing a renewal for this activity, and requested public comment on a potential renewal under those circumstances. Specifically, on a case-by-case basis, NMFS may issue a one-time 1-year renewal of an IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical, or nearly identical, activities as described in the Detailed Description of Specified Activities section of the initial IHA issuance notice is planned; or (2) the activities as described in the Description of the Specified Activities and Anticipated Impacts section of the initial IHA issuance notice would not be completed by the time the initial IHA expires and a renewal would allow for completion of the activities beyond that described in the
1. A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA);
2. The request for renewal must include the following:
• An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (
• A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized; and
3. Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
An additional public comment period of 15 days (for a total of 45 days), with direct notice by email, phone, or postal service to commenters on the initial IHA, is provided to allow for any additional comments on the proposed renewal. A description of the renewal process may be found on our website at:
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental take authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS determined that the issuance of the initial IHA qualified to be categorically excluded from further NEPA review. NMFS has preliminarily determined that the application of this categorical exclusion remains appropriate for this renewal IHA.
On March 29, 2023, NMFS issued an IHA to TMC to take marine mammals incidental to the construction of the cruise ship dock in Whittier, Alaska (88 FR 19927, April 4, 2023), effective from April 1, 2023 through March 31, 2024. On November 16, 2023, NMFS received an application for the renewal of that initial IHA. As described in the application for renewal IHA, the activities for which incidental take is requested consist of activities that are covered by the initial authorization but will not be completed prior to its expiration. As required, the applicant also provided a preliminary monitoring report which confirms that the applicant has implemented the required mitigation and monitoring, and which also shows that no impacts of a scale or nature not previously analyzed or authorized have occurred as a result of the activities conducted.
TMC's planned cruise ship construction project was planned to cover a 12-month window during which approximately 129 days of pile-installation and -removal activity will occur. This project involved installation and removal of seventy-two 36-inch (in) (0.91-meter (m)) temporary steel pile guides and installation of thirty-six 36-in (0.91-m), sixteen 42-in (1.1-m), and twenty 48-in (1.2-m) permanent steel piles. Three different installation methods were planned to be used including vibratory installation of piles into dense material, impact pile driving to drive piling to tip elevation, and the Down-the-Hole (DTH) hammer to drill pile into the bedrock. TMC planned to deploy a bubble curtain to the 60-foot (ft) (18.3-m) isobath. This was planned to be used during all activities that fall below the 60-ft (18.3-m) isobath.
Due to unexpected winter weather conditions causing slower construction, TMC will not complete the initial construction during the 1-year period. Specifically, at the time of the renewal request, TMC had completed installation of 51 permanent piles to construct the approach trestle, 2 float restraint dolphins, and most of the mooring trestle. With the remaining time under the initial IHA, TMC anticipates completing at a minimum installation of 10 additional permanent piles.
This renewal request is to cover the subset of the activities covered in the initial IHA that will not be completed during the effective IHA period. TMC plans to complete the remaining
The likely or possible impacts of the TMC's proposed activity on marine mammals could involve both non-acoustic and acoustic stressors and is unchanged from the impacts described in the initial IHA. Potential non-acoustic stressors could result from the physical presence of the equipment, vessels, and personnel; however, any impacts to marine mammals are expected to primarily be acoustic in nature. Sounds resulting from pile installation, removal, and drilling may result in the incidental take of marine mammals by Level A and Level B harassment in the form of auditory injury or behavioral harassment.
A detailed description of the construction activities for which take is proposed here may be found in the notices of the proposed and final IHAs for the initial authorization (88 FR 9227, February 13, 2023; 88 FR 19927, April 4, 2023). As previously mentioned, this request is for a subset of the activities considered for the initial IHA that would not be completed prior to its expiration. The location, timing, and nature of the activities, including the types of equipment planned for use, are identical to those described in the previous notice for the initial IHA. The proposed renewal IHA would be effective from April 1, 2024 through March 31, 2025.
A description of the marine mammals in the area of the activities for which authorization of take is proposed here, including information on abundance, status, distribution, and hearing, may be found in the notice of the proposed IHA for the initial authorization (88 FR 9227, February 13, 2023).
Since the initial IHA was published, NMFS published the final 2022 Alaska and Pacific Stock Assessment Reports (SARs), which describe revised stock structures under the MMPA for humpback whales. In the initial notice of proposed and final IHAs, we explained these proposed changes and that these changes would be adopted when final. Upon finalization of these revised stock structures, we have made appropriate updates, including attribution of take numbers to stock (see Estimated Take).
The revision to humpback whale stock structure modifies the previously MMPA-designated humpback stocks to align more closely with the ESA-designated distinct population segments (DPSs) (Caretta
In the initial notice of the proposed and final IHA, NMFS assumed that humpbacks in the action area were from the Central North Pacific Stock, Western North Pacific Stock, and CA/OR/WA Stock, and therefor authorized take of humpbacks from these stocks. Based on the revised stock designations, no take of WNP stock whales would occur, and in the proposed renewal IHA humpback whales are now assumed to be members of either the Hawaii stock or the Mexico-North Pacific stock, which corresponds with the takes previously authorized for the Central North Pacific Stock and CA/OR/WA Stocks, respectively. However, based on the work remaining in the renewal IHA, the takes proposed for authorization through this renewal would only be from the Hawaii stock. In southeast Alaska, it is likely that only 2% of humpbacks would be from the Mexico-North Pacific stock, and based on the proportionally reduced take in this renewal, there are no calculated takes of the Mexico-North Pacific stock. Therefor in this renewal IHA, we propose to authorize take only of the Hawaii stock of humpback whale.
NMFS has reviewed the preliminary monitoring data from the initial IHA, recent draft and final Stock Assessment Reports including the updated humpback whale stock structure, and determined that neither this nor any other new information affects which species have the potential to be affected or the pertinent information in the Description of the Marine Mammals in the Area of Specified Activities contained in the supporting documents for the initial IHA (88 FR 9227, February 13, 2023).
A description of the potential effects of the specified activity on marine mammals and their habitat for the activities for which the authorization of take is proposed here may be found in the notice of the proposed IHA for the initial authorization (88 FR 9227, February 13, 2023). NMFS has reviewed the monitoring data from the initial IHA, recent draft Stock Assessment Reports, information on relevant Unusual Mortality Events, and other scientific literature, and determined that neither this nor any other new information affects our initial analysis of impacts on marine mammals and their habitat.
A detailed description of the methods and inputs used to estimate take for the specified activity are found in the notices of the proposed and final IHAs for the initial authorization (88 FR 9227, February 13, 2023; 88 FR 19927, April 4, 2023). Specifically, days of operation, area or space within which harassment is likely to occur, and marine mammal occurrence data applicable to this authorization remain unchanged from the initial IHA. Similarly, methods of take, daily take estimates and types of take remain unchanged from the initial IHA. The number of takes proposed for authorization in this renewal are a subset of the initial authorized takes that better represent the amount of activity left to complete. These takes, which reflect the lower number of remaining days of work, are indicated below in table 1. Takes are calculated using the same methodology as the initial IHA, and are just a proportion of the initial takes based on the days of work remaining.
The proposed mitigation, monitoring, and reporting measures included as requirements in this authorization are almost identical to those included in the FR notice announcing the issuance of the initial IHA, and the discussion of the least practicable adverse impact included in that document remains accurate (88 FR 19927, April 4, 2023).
The following mitigation, monitoring, and reporting measures are proposed for this renewal:
• The TMC must avoid direct physical interaction with marine mammals during construction activity. If a marine mammal comes within 10-m of such activity, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions, as necessary to avoid direct physical interaction;
• Conduct training between construction supervisors and crews and the marine mammal monitoring team and relevant TMC staff prior to the start of all pile driving activity and when new personnel join the work, so that responsibilities, communication procedures, monitoring protocols, and operational procedures are clearly understood;
• Pile driving activity must be halted upon observation of either a species for which incidental take is not authorized or a species for which incidental take has been authorized but the authorized number of takes has been met, entering or within the harassment zone;
• TMC will establish and implement the shutdown zones. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). Shutdown zones typically vary based on the activity type and marine mammal hearing group;
• Monitoring must take place from 30 minutes prior to initiation of construction activity (
• Pre-start clearance monitoring must be conducted during periods of visibility sufficient for the lead Protected Species Observer (PSO) to determine the shutdown zones clear of marine mammals. Construction may commence when the determination is made;
• If construction is delayed or halted due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily exited and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal;
• TMC must use soft start techniques when impact pile driving. Soft start requires contractors and equipment to slowly approach the work site creating a visual disturbance allowing animals in close proximity to construction activities a chance to leave the area prior to stone resetting or new stone placement. A soft start must be implemented at the start of each day's construction activity and at any time following cessation of activity for a period of 30 minutes or longer;
• The TMC must employ up to four PSOs to monitor the shutdown and Level B harassment zones during pile driving and DTH activities;
• Monitoring will be conducted 30 minutes before, during, and 30 minutes after construction activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from construction activity;
• The TMC must submit a draft report detailing all monitoring within 90 calendar days of the completion of marine mammal monitoring or 60 days prior to the issuance of any subsequent IHA for this project, whichever comes first;
• TMC must conduct hydroacoustic monitoring as specified in the initial IHA and submit a hydroacoustic monitoring report;
• The TMC must prepare and submit final report within 30 days following resolution of comments on the draft report from NMFS;
• The TMC must submit all PSO datasheets and/or raw sighting data (in a separate file from the Final Report referenced immediately above); and
• The TMC must report injured or dead marine mammals.
As noted previously, NMFS published a notice of a proposed IHA (88 FR 9227, February 13, 2023) and solicited public comments on both our proposal to issue the initial IHA for Whittier Head of the Bay cruise ship dock project and on the potential for a renewal IHA, should certain requirements be met. During the 30-day public comment period, NMFS received no comments on either the proposal to issue the initial IHA for TMC's construction activities or on the potential for a renewal IHA.
The proposed renewal request consists of a subset of activities analyzed through the initial authorization described above. In analyzing the effects of the activities for the initial IHA, NMFS determined that TMC's activities would have a negligible impact on the affected species or stocks and that authorized take numbers of each species or stock were small relative to the relevant stocks (
NMFS has preliminarily concluded that there is no new information suggesting that our analysis or findings should change from those reached for the initial IHA. Based on the
The NMFS Alaska Regional Office issued a Biological Opinion under section 7 of the Endangered Species Act (ESA; 16 U.S.C. 1531
As a result of these preliminary determinations, NMFS proposes to issue a renewal IHA to TMC for conducting the cruise ship dock construction in Whittier, Alaska, from April 1, 2024 through March 31, 2025, provided the previously described mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed and final initial IHA can be found at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
Pacific Fishery Management Council (Pacific Council) staff will provide an online briefing on the outcomes of the January 18-19, 2024, meeting of the Ad Hoc Committee of the Whole.
The online meeting will be held on Friday, March 29, 2024, 3-5 p.m. Pacific time.
This meeting will be held online. Specific meeting information, including directions on how to join the meeting and system requirements will be provided in the meeting announcement on the Pacific Council's website (see
Kelly Ames, Deputy Director, Pacific Council; telephone: (503) 820-2417.
The Pacific Council created the Ad Hoc Committee of the Whole (COTW), composed of Pacific Council members, to make recommendations on Council operations in light of the Pacific Council's medium and long-term financial status. A report of the COTW, including its recommendations, will be reported to the Pacific Council at its April 9-11, 2024, meeting. Based on these recommendations, the Pacific Council's Executive Director will propose potential changes to Pacific Council operations in line with anticipated budget ceilings for the next three to five years. In this online briefing Pacific Council staff will summarize outcomes of the COTW meeting for Pacific Council advisory bodies and the public to allow informed comment at the April Pacific Council meeting.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
Consumer Financial Protection Bureau.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (CFPB) is requesting the Office of Management and Budget's (OMB's) approval for a new information collection titled “Consumer Complaint Survey.”
Written comments are encouraged and must be received on or before May 6, 2024 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
•
•
•
Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or Social Security numbers, should not be included.
Requests for additional information should be directed to Anthony May, PRA Officer, at (202) 435-7278, or email:
The CFPB proposes to collect data with two new surveys intended to identify factors that influence a consumer's decision to use the complaint process. The initial pilot survey will focus on consumers who have experienced issues with their credit cards and will include a sample of people who have used the CFPB's complaint process, and another sample of people who experienced similar issues but did not file a complaint with the CFPB. This design (known as a case-control study) will allow us to identify key factors that are associated with submitting regulatory complaints.
The pilot survey will inform a second survey which will focus on a broader range of products and services. The second survey will (to the extent feasible) cover additional products about which consumers can submit complaints to the CFPB including (but not limited to) mortgages, vehicle loans, bank accounts, and debts owed to third-party debt collectors. Both surveys will collect data about factors that may play a role in consumer's decision to submit a complaint. These include information about their use of a given product, the problems they encountered when using a given product, their attitudes and perceptions towards the product and its offeror, as well as demographic information.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of limitation on claims for judicial review of actions by the U.S. Army Corps of Engineers (USACE).
USACE announces final agency action on the USACE authorization for the proposed construction and maintenance of the Revolution Wind Farm and Revolution Wind Offshore Export Cable Project (the Revolution Wind Project) offshore Rhode Island. USACE has issued a permit authorizing the construction and maintenance of the Revolution Wind Project under section 10 of the Rivers and Harbors Act of 1899 (RHA) and section 404 of the Clean Water Act (CWA). The Revolution Wind Project is a “covered project” under title 41 of the Fixing America's Surface Transportation Act.
A claim seeking judicial review of the USACE authorization of construction and maintenance of the Revolution Wind Project will be barred unless the claim is filed not later than two years after this notice's publication date. If the Federal law that allows for judicial review of the USACE authorization specifies a shorter time period for filing such a claim, then that shorter time period will apply.
Ms. Ruth Brien, Regulatory Project Manager, Regulatory Division, USACE, New England District, 696 Virginia Road, Concord, Massachusetts 01742, (978) 318-8054 or
Notice is hereby given that USACE has taken final agency action on its authorization for the proposed Revolution Wind Project by issuing a permit authorizing construction and maintenance of the Project under section 10 of the RHA and section 404 of the CWA. The majority of the authorized work will occur in the Atlantic Ocean within the Bureau of Ocean Energy Management (BOEM) Renewable Energy Lease Area OCS-A-0486, which is approximately 15 nautical miles (nm) southeast of Point Judith, Rhode Island, approximately 13 nm east of Block Island, Rhode Island, and approximately 7.5 nm south of Nomans Land Island National Wildlife Refuge.
The work authorized under the USACE permit includes the following: (1) the installation of up to 65 wind turbine generators (WTGs) and up to 2 offshore substations (OSSs) with associated scour protection, (2) the installation of 155 miles of inter-array cables connecting the WTGs and 9 miles of inter-link cables connecting the OSSs with associated secondary cable protection as needed, and (3) installation of up to 2 export transmission cables with associated secondary cable protection within a 42-
The USACE's decision to issue a permit, and the laws under which the action was taken, are described in the Revolution Wind Export Cable Project Final Environmental Impact Statement (FEIS) published on July 21, 2023, in the joint Record of Decision (ROD) issued on August 21, 2023, and in other project records. The FEIS, ROD, and other documents can be viewed and downloaded from the BOEM project website at
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notification of determination.
The U.S. Department of Energy (DOE) has reviewed ANSI/ASHRAE/IES Standard 90.1-2022:
Certification statements provided by States shall be submitted by March 6, 2026.
A copy of the supporting analysis, as well a link to the Federal docket, is available at:
Certification Statements must be addressed to the Building Technologies Office—Building Energy Codes Program Manager, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW, EE-5B, Washington, DC 20585.
Mr. Jeremiah Williams; U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW, EE-5B, Washington, DC 20585; (202) 441-1288;
For legal issues, please contact: Ms. Laura Zuber; U.S. Department of Energy, Office of the General Counsel, 1000 Independence Avenue SW, GC-33, Washington, DC 20585; (240) 306-7651;
Title III of the Energy Conservation and Production Act, as amended (ECPA), establishes requirements for DOE to review consensus-based building energy conservation standards. (42 U.S.C. 6831
ANSI/ASHRAE/IES Standard 90.1-2022 (Standard 90.1-2022 or the “Standard”), the most recent edition, was published in January 2023, triggering the statutorily required DOE review process. Standard 90.1-2022 is developed under ANSI-approved procedures,
In support of its model energy code determinations, DOE conducts a technical analysis to assess the energy savings impacts associated with the updated code (Standard 90.1-2022). DOE's review under ECPA is technical in nature and helps to inform and advise interested industry stakeholders of the effects of the updated code, as well as states and local governments who ultimately adopt, implement and enforce building codes. Although, DOE is an active participant in the review and update process for Standard 90.1-2022, as directed under ECPA (42 U.S.C. 6836(b)), the Department neither administers nor publishes the model energy codes. Additionally, the directive for states to update their energy efficiency codes based on the updated edition of Standard 90.1-2022 is ultimately rooted in ECPA. DOE's technical analysis serves as basis for DOE's determination and helps inform adopting states who seek to update their codes and comply with ECPA.
DOE's full technical analysis, including assumptions and parameters applied in the analysis, is published as a separate technical support document (TSD) and available for review at
DOE publishes a wide range of technical assistance resources supporting building energy codes. This includes additional technical analyses evaluating the impacts of updated building energy codes, such as quantifying energy and environmental benefits, as well as additional resources supporting the adoption and successful implementation of energy codes across states and local governments. New federal assistance is also available supporting state and local adoption and implementation of building energy codes through the Bipartisan Infrastructure Law (Section 40511) and Inflation Reduction Act (Section 50131). Visit
Commercial buildings meeting Standard 90.1-2022 (compared to the previous 2019 edition) are expected to experience the following savings on a weighted national average basis:
DOE concludes that Standard 90.1-2022 will improve energy efficiency in commercial buildings, and, therefore, receives an affirmative determination under Section 304(a) of ECPA.
Upon publication of this affirmative determination, ECPA requires each State to review and update, as necessary, the provisions of its commercial building energy code to meet or exceed the Standard 90.1-2022 with regard to energy efficiency.
DOE recognizes that some States do not have a State commercial building energy code or have a State code that does not apply to all commercial buildings. States may base their certifications on reasonable actions by units of general-purpose local government. Each such State must review the information obtained from the local governments and gather any additional data and testimony in preparing its own certification.
The applicability of any State revisions to new or existing buildings would be governed by the State building codes. States should be aware that the scope of Standard 90.1-2022 includes high-rise (greater than three stories) multi-family residential buildings, and hotels, motels, and other transient residential building types of any height, as commercial buildings for energy code purposes. Consequently, commercial buildings, for the purposes of certification to DOE, would include high-rise multi-family residential buildings, hotels, motels, and other transient residential building types of any height.
Section 304(b) of ECPA, as amended, requires each State to certify to the Secretary of Energy that it has reviewed and updated the provisions of its commercial building energy code regarding energy efficiency to meet or exceed the Standard 90.1-2022. 42 U.S.C. 6833(b). The certification must include a demonstration that the provisions of the State's commercial building energy code regarding energy efficiency meets or exceeds Standard 90.1-2022. If a State intends to certify that its commercial building energy code already meets or exceeds the requirements of Standard 90.1-2022, the State should provide an explanation of the basis for this certification (
The DOE Building Energy Codes Program tracks and reports State code adoption and certification.
Section 304(c) of ECPA requires that the Secretary permit an extension of the deadline for complying with the certification requirements described previously, if a State can demonstrate that it has made a good faith effort to comply with such requirements and that it has made significant progress toward meeting its certification obligations. (42 U.S.C. 6833(c)) Such demonstrations could include one or both of the following: (1) a plan for response to the requirements stated in Section 304; or (2) a statement that the State has appropriated or requested funds (within State funding procedures) to implement a plan that would respond to the requirements of Section 304 of ECPA. This list is not exhaustive. Requests are to be sent to the address provided in the
This document of the Department of Energy was signed on February 26, 2024, by Jeffrey M. Marootian, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been
Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy.
Notice and request for OMB review and comment; correction.
The Department of Energy (DOE) published in the
Requests for additional information or copies of the EERE Environmental Questionnaire should be directed to Andrew M. Montano at:
In the
This document of the Department of Energy was signed on February 29, 2024, by Matthew Blevins, Director, Environment, Safety and Health Office, Golden Field Office, Office of Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Department of Energy.
Notice of open meeting.
The Department of Energy hereby publishes a notice of open meeting of the Electric Vehicle Working Group (EVWG). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the
Tuesday, April 2, 2024; 9:30 a.m. to 4 p.m. Eastern Time and Wednesday, April 3, 2024; 8:30 a.m. to 2:30 p.m. Eastern Time. Start and end times may change slightly. Please visit
The meeting will be held for members of the EVWG at the U.S. Department of Transportation 1200 New Jersey Avenue SE, Washington, DC 20590. Members of the public who would like to participate may do so virtually and must register at:
Dr. Rachael Nealer, Designated Federal Officer, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585; email:
Individuals and representatives of organizations who would like to offer comments and suggestions may do so during the public comment portion of the meeting. Approximately 30 minutes will be reserved for public comments near the end of each meeting day. Time allotted per speaker will depend on the number who wish to speak but will not exceed three minutes. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Those wishing to speak during the public comment period should indicate so within their registration.
Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to Dr. Rachael Nealer, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, or email:
Grid Deployment Office (GDO), U.S. Department of Energy (DOE).
Notice of request for comments.
The Department of Energy (DOE) invites public comment on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. The proposed collection will be used to accept applications and required supporting materials from applicants as required to receive payments for hydroelectric incentive programs.
Comments regarding this proposed information collection must be received before on or before April 5, 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 notice, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at (202) 395-4718.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Questions may be addressed to Madden Sciubba, U.S. Department of Energy, 1000 Independence Ave. SW, Washington, DC 20585, (240) 798-1195 or by email at
Comments are invited on: (a) Whether the extended collection of information is 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, including the validity of the methodology and assumptions used; (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.
This information collection request contains:
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This document of the Department of Energy was signed on February 29, 2024, by Maria D. Robinson, Director, Grid Deployment Office. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Federal Implementation Plan for Oil and Natural Gas Well Production Facilities, Fort Berthold Indian Reservation (Mandan, Hidatsa, and Arikara Nation), North Dakota. (EPA ICR Number 2478.04, OMB Control Number 2008-0001) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act.This is a proposed extension of the ICR, which is currently approved through March 31, 2024. Public comments were previously requested via the
Comments may be submitted on or before April 5, 2024.
Submit your comments, referencing Docket ID Number EPA-R08-OAR-2023-0412 to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Adam Eisele, U.S. Environmental Protection Agency, Region 8, Air and Radiation Division, (Mail Code 8ARD-PM), 1595 Wynkoop Street, Denver, Colorado 80202-1129, telephone number: (303) 312-6246, email address:
This is a proposed extension of the ICR, which is currently approved through March 31, 2024. 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.
Public comments were previously requested via the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Confidential Financial Disclosure Form for Special Government Employees at the EPA (EPA ICR Number 2260.08, OMB Control Number 2090-0029) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through June 30, 2024. Public comments were previously requested via the
Comments may be submitted on or before April 5, 2024.
Submit your comments, referencing Docket ID Number EPA-HQ-OA-2010-0757, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Gina Moore, Office of Inclusive Excellence, Federal Advisory Committee Management and Oversight Division, Mail Code 1601M, Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: 202-566-0462,
This is a proposed extension of the ICR, which is currently approved through June 30, 2024. 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.
Public comments were previously requested via the
Agency officials developed the “Confidential Financial Disclosure Form for Special Government Employees at the U.S. Environmental Protection Agency,” also referred to as Form 3110-48, for greater inclusion of information to discover any potential conflicts of interest as recommended by the Government Accountability Office.
Environmental Protection Agency (EPA).
Notification of webinar.
The Environmental Protection Agency (EPA) is announcing a public webinar on the Biogas Regulatory Reform Rule (BRRR) provisions of the Renewable Fuel Standard (RFS) program.
The webinar will be held on April 4, 2024, from 1:00-4:30 p.m., Eastern Time. Additional information regarding the workshop appears below under
All attendees must pre-register for the webinar by notifying the contact person listed under
Nick Parsons, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency; telephone number: (734) 214-4479; email address:
EPA is hosting a public webinar to discuss the implementation of the Biogas Regulatory Reform Rule (BRRR) provisions promulgated as part of the Renewable Fuel Standard (RFS) final rule for 2023-2025 (the “Set Rule”).
During the webinar, EPA intends to discuss various aspects of the BRRR program, including:
• The implementation timeline for BRRR.
• An implementation overview of the BRRR program.
• EPA Central Data Exchange (CDX) registration for biogas producers, renewable natural gas (RNG) producers, RNG RIN separators, and performing required associations.
• Alternative measurement protocols.
EPA will post an agenda approximately one week before the webinar at:
If you require the services of an interpreter or special accommodations such as audio description, please pre-register for the webinar and describe your needs by March 28, 2024. EPA may not be able to arrange accommodations without advance notice.
Environmental Protection Agency (EPA).
Notice; extension of comment period.
In the
The comment period at 88 FR 87423 is extended for MBOCA. Comments for MBOCA must be received on or before April 17, 2024.
Submit your comments for MBOCA, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0464, through
In response to a stakeholder's request for additional time to review materials and prepare comments for MBOCA, EPA is extending the comment period for MBOCA that was established in the
In addition, EPA would also like to clarify that the
To submit comments or access the docket, please follow the detailed instructions provided under
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office is announcing two public meetings of the Clean Air Scientific Advisory Committee (CASAC) Nitrogen Oxides (NO
Both meetings will be conducted virtually. Please refer to the CASAC website at
Any member of the public wishing further information concerning this notice may contact Mr. Aaron Yeow, Designated Federal Officer (DFO), via telephone at (202) 564-2050, or email at
Environmental Protection Agency (EPA).
Notice.
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates with expertise in the areas of toxicology, bioethics, and statistics to be considered for appointment to its Human Studies Review Board (HSRB) Federal advisory committee. Submission of nominations will be made via the HSRB website at:
Nominations should be submitted by March 29, 2024.
Please submit nominations by completing the nomination form provided on the HSRB website at
Any member of the public needing additional information regarding this Notice and Request for Nominations may contact Mr. Tom Tracy, Office of Science Advisor, Policy and Engagement, Office of Research and Development, Mail Code B343-01, 109 T.W. Alexander Drive, Research Triangle Park, NC 27711; via phone/voice mail at: (919) 541-4334; or via email at:
On February 6, 2006, the Agency published a final rule for the protection of human subjects in research (71 FR 6138) that called for creating a new, independent human studies review board (
HSRB members serve as special government employees or regular government employees. Members are appointed by the EPA Administrator for either two or three year terms with the possibility of reappointment for additional terms, for a maximum of six years of service. The HSRB convenes on average four times a year, with all of the meetings being virtual. The average workload for HSRB members is approximately 20 hours per meeting, including the time spent at the meeting. Responsibilities of HSRB members include reviewing extensive background materials prior to meetings of the Board, preparing draft responses to Agency charge questions, attending Board meetings, participating in the discussion and deliberations at these meetings, drafting assigned sections of meeting reports, and assisting with the finalization of HSRB reports. EPA compensates special government employees for their time and provides reimbursement for travel and other incidental expenses associated with official government business related to the HSRB meetings.
Members of the HSRB are subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, each nominee will be asked to submit confidential financial information that fully discloses, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. The information provided is strictly confidential and will not be disclosed to the public. Before a candidate is considered further for service on the HSRB, EPA will evaluate each candidate to assess whether there is any conflict of financial interest, appearance of a lack of impartiality, or prior involvement with matters likely to be reviewed by the Board.
To nominate a candidate for consideration or self-nominate, please visit the HSRB website at
Nominations will be evaluated on the basis of several criteria, including: professional background, expertise, and experience that would contribute to the diversity of perspectives of the committee; interpersonal, oral, and written communication skills and other attributes that would contribute to the HSRB's collaborative process; consensus building skills; absence of any financial conflicts of interest or the appearance of a lack of impartiality, or lack of independence, or bias; and the
Candidates not selected for HSRB membership at this time may be considered for HSRB membership as vacancies arise in the future or for service as consultants to the HSRB.
To help the Agency in evaluating the effectiveness of its outreach efforts, nominees are requested to inform the Agency of how you learned of this opportunity.
Final selection of HSRB members is a discretionary function of the Agency and will be announced as soon as selections are made on the HSRB website at
10 a.m., Thursday, March 14, 2024.
You may observe the open portions of 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
Parts of this meeting will be open to the public. The rest of the meeting will be closed 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
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than March 21, 2024.
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Board of Governors of the Federal Reserve System.
Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS).
Notice of availability—new common formats.
As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of
The
Dr. Hamid Jalal, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Rockville, MD 20857; Telephone (toll free): (866) 403-3697; Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130; Email:
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the
The Patient Safety Act provides for the development of standardized reporting formats using common language and definitions (Common Formats) to ensure that health care quality and patient safety data collected by PSOs and other entities are comparable. The Common Formats facilitate aggregation of comparable data at local, PSO, regional and national levels. In addition, the formats are intended to enhance the reporting of information that is standardized both clinically and electronically.
AHRQ has developed Common Formats for Event Reporting for three settings of care—acute care hospitals, nursing homes, and community pharmacies—as well as for diagnostic safety events across all care settings. AHRQ-listed PSOs are required to collect patient safety work product in a standardized manner to the extent practical and appropriate; this is a requirement the PSO can meet by collecting such information using Common Formats. Additionally, providers and other organizations not working with an AHRQ-listed PSO can use the Common Formats in their work to improve quality and safety; however, they cannot benefit from the Federal confidentiality and privilege protections of the Patient Safety Act.
Since February 2005, AHRQ has convened the Federal Patient Safety Work Group (PSWG) to assist AHRQ in developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS as well as the Departments of Defense and Veterans Affairs. The PSWG helps assure the consistency of definitions/formats with those of relevant government agencies. In addition, AHRQ solicit comments from the private and public sectors regarding proposed versions of the Common Formats through the Patient Safety Organization Privacy Protection Center (PSOPPC). After receiving comments, the PSOPPC will solicit review of the formats by its Common Formats Expert Panel. Subsequently, PSOPPC will review this input and provide its feedback to AHRQ who then uses it to refine the Common Formats.
For the Common Formats, it should be noted that AHRQ uses the term “surveillance” in this context to refer to the improved detection of events and calculation of adverse event rates in populations reviewed that will allow for collection of comparable performance data over time and across populations of patients. These formats are designed to provide, through retrospective review of medical records, information that is complementary to that derived from event reporting systems.
AHRQ is specifically interested in receiving feedback in order to guide the improvement of the formats. The draft Event Descriptions for the
Additional information about the Common Formats can be obtained through AHRQ's PSO website:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
The Centers for Disease Control and Prevention, within the Department of Health and Human Services, announces the next meeting of the Community Preventive Services Task Force (CPSTF) on April 17-18, 2024.
The meeting will be held on Wednesday, April 17, 2024, from 9 a.m. to 5 p.m. EDT, and Thursday, April 18, 2024, from 9 a.m. to 5 p.m. EDT.
The meeting will be available to the public via web conference.
Kenya Turner, Office of Science, Office of Scientific Evidence and Recommendations, Community Guide Program; Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-H21-10, Atlanta, GA 30329. Telephone: (404) 718-4592; Email:
All meeting attendees must register by April 10, 2024. CDC will email web
To register for the meeting, individuals should send an email to
The meeting agenda is subject to change without notice.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of public teleconference and request for information.
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is announcing a meeting and opportunity to comment on a human West Nile virus (WNV) vaccine. The primary purpose of the meeting is to inform critical next steps toward the deployment of a human WNV vaccine.
The meeting will be held on April 5, 2024, from 8 a.m. to 5 p.m., eastern time.
Written comments must be received on or before April 4, 2024.
You may submit written comments, identified by docket number CDC-2024-0017, by either of the following two methods listed below. CDC does not accept comments by email.
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Randall J. Nett, MD MPH, Chief, Arboviral Diseases Branch, 3156 Rampart Road, MS P02, Fort Collins, CO 80521; telephone number: (970) 221-6400; email address
Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. We have determined that COLA meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant COLA deeming authority for a period of 6 years.
Jelani Sanaa, (410) 786-1139.
On October 31, 1988, the Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (Pub. L. 100-578) (CLIA). CLIA amended section 353 of the Public Health Service Act. We issued a final rule implementing the accreditation provisions of CLIA on July 31, 1992 (57 FR 33992). Under those provisions, we may grant deeming authority to an accreditation organization if its requirements for laboratories accredited under its program are equal to or more stringent than the applicable CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). Subpart E of part 493 (Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program) specifies the requirements an accreditation organization must meet to be approved by CMS as an accreditation organization under CLIA.
In this notice, we approve COLA as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements for the following specialty and subspecialty areas under CLIA:
• Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology.
• Diagnostic Immunology, including Syphilis Serology, and General Immunology.
• Chemistry, including Routine Chemistry, Toxicology, and Endocrinology.
• Hematology, including routine hematology and coagulation.
• Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification.
• Pathology, including Histopathology, Oral Pathology, and Cytology.
We have examined the initial COLA application and all subsequent submissions to determine its accreditation program's equivalency with the requirements for re-approval of an accreditation organization under subpart E of part 493. We have determined that COLA meets or exceeds the applicable CLIA requirements. We have also determined that COLA will ensure that its accredited laboratories will meet or exceed the applicable requirements in subparts H, I, J, K, M, Q, and the applicable sections of R. Therefore, we grant COLA re-approval as an accreditation organization under subpart E of part 493, for the period stated in the
The following describes the process we used to determine that COLA's accreditation program meets the necessary requirements to be approved by CMS and that, as such, CMS may approve COLA as an accreditation program with deeming authority under the CLIA program. COLA formally applied to CMS for re-approval as an accreditation organization under CLIA for the following specialties and subspecialties:
• Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology.
• Diagnostic Immunology, including Syphilis Serology, and General Immunology.
• Chemistry, including Routine Chemistry, Toxicology, and Endocrinology.
• Hematology, including routine hematology and coagulation.
• Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification.
• Pathology, including Histopathology, Oral Pathology, and Cytology.
In reviewing these materials, we reached the following determinations for each applicable part of the CLIA regulations:
COLA submitted a description of its mechanisms for monitoring compliance with all requirements equivalent to condition-level requirements, a list of all its current laboratories and the expiration date of their accreditation, and a detailed comparison of COLA's individual accreditation requirements with the comparable condition-level requirements. We determined COLA's policies and procedures for oversight of laboratories performing laboratory testing for the submitted CLIA specialties and subspecialties for inspection, monitoring proficiency testing (PT) performance, investigating complaints, and making PT information available, are equivalent to those of CLIA. COLA also submitted descriptions of its infrastructure and procedures for monitoring and inspecting laboratories in the areas of data management, the inspection process, procedures for removal or withdrawal of accreditation, notification requirements for laboratories out of compliance, and accreditation organization resources. We have determined that the requirements of COLA's accreditation program are equal to or more stringent than our requirements of the CLIA regulations.
Our evaluation determined that COLA requirements regarding waived testing are more stringent than the CLIA requirements at § 493.15(e) that require eligible laboratories to follow the manufacturer's instructions for performing tests and obtain a certificate of waiver as outlined in subpart B, Certificate of Waiver. COLA requires the laboratory director to review quality control results for waived tests monthly and also requires that competency be assessed and documented for personnel performing waived testing.
We have determined that COLA's requirements are equal to the CLIA requirements at §§ 493.801 through 493.865. Like CLIA, all of COLA's accredited laboratories are required to participate in an HHS-approved PT program for tests listed in subpart I. COLA also encourages its accredited laboratories to participate in PT for tests that are waived under CLIA.
We have determined that COLA's requirements are equal to the CLIA requirements at §§ 493.1100 through 493.1105.
We have determined that COLA's requirements are equal to the CLIA requirements at §§ 493.1200 through 493.1299.
We have determined that COLA's requirements are equal to the CLIA requirements at §§ 493.1403 through 493.1495 for laboratories that perform moderate and high complexity testing.
We have determined that COLA's requirements are equal to the CLIA requirements at §§ 493.1771 through 493.1780. COLA will continue to conduct biennial onsite inspections. An unannounced inspection would be performed when a complaint, lodged against a laboratory accredited by COLA, indicates that problems may exist within the laboratory that may have a serious or immediate impact on patient care.
We have determined that COLA meets the requirements of subpart R to the extent that such requirements apply to accreditation organizations. COLA policy sets forth the actions the organization takes when laboratories it accredits do not comply with its requirements and standards for accreditation. When appropriate, COLA will deny, suspend, or revoke accreditation in a laboratory accredited by COLA and report that action to CMS within 30 days. COLA also provides an appeals process for laboratories that have had accreditation denied, suspended, or revoked.
The Federal validation inspections of laboratories accredited by COLA may be conducted on a representative sample basis or in response to substantial allegations of noncompliance (that is, complaint inspections). The outcome of those validation inspections, performed by CMS or CMS agents, or the State survey agencies, will be our principal means for verifying that the laboratories accredited by COLA remain in compliance with CLIA requirements. This Federal monitoring is an ongoing process.
CLIA regulations provide that we may withdraw the approval of an accreditation organization, such as that of COLA, before the end of the effective date of approval in certain circumstances, in accordance with § 493.575. If we determine that COLA has failed to adopt, maintain and enforce requirements that are equal to, or more stringent than, the CLIA requirements, or that systemic problems exist in its monitoring, inspection or enforcement processes, we may impose a probationary period 30 days following the date of CMS' determination, not to exceed 1 year, in which COLA would be allowed to address any identified issues, pursuant to our rules at § 493.575(b). Should COLA be unable to address the identified issues, CMS may, in accordance with the applicable regulations, revoke COLA's deeming authority under CLIA.
Should circumstances result in our withdrawal of COLA's re-approval, we will publish a notice in the
The information collection requirements associated with the accreditation process for clinical laboratories under the CLIA program are currently the Office of Management and Budget (OMB)-approved under OMB control number 0938-0686 and expires May 31, 2025. Additionally, this notice does not impose any new or revised information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, it does not need to be reviewed by OMB under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
In accordance with the provisions of Executive Order 12866, this notice was not reviewed by the Office of Management and Budget.
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by May 6, 2024.
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
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed 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) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports food safety projects administered by FDA. The FDA's National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data was collected in retail and foodservice establishments at 5-year intervals (1998, 2003, and 2008) in order to observe and document trends in the occurrence of the following foodborne illness risk factors:
• Food from Unsafe Sources,
• Poor Personal Hygiene,
• Inadequate Cooking,
• Improper Holding/Time and Temperature, and
• Contaminated Equipment/Cross-Contamination.
FDA developed reports summarizing the findings for each of the three data collection periods, released in 2000, 2004, and 2009.
Using this 10-year survey as a foundation, FDA initiated a new study in full-service and fast-food restaurants. This study will include data collections completed in 2013-2014 and 2017-2018. An additional collection planned for 2021-2022 was halted due to the COVID-19 pandemic; however, an additional data collection is planned for 2023-2025 (the subject of this information collection request extension). Three data collections are necessary to trend the data.
• Develop retail food safety initiatives, policies, and targeted intervention strategies focused on controlling foodborne illness risk factors;
• Provide technical assistance to State, local, tribal, and territorial regulatory professionals;
• Identify FDA retail work plan priorities; and
• Inform FDA resource allocation to enhance retail food safety nationwide.
• Identify the least and most often occurring foodborne illness risk factors and food safety behaviors/practices in restaurants within the United States;
• Determine the extent to which Food Safety Management Systems and the presence of a Certified Food Protection Manager impact the occurrence of foodborne illness risk factors and food safety behaviors/practices; and
• Determine whether the occurrence of foodborne illness risk factors food safety behaviors/practices in delis differs based on an establishment's risk categorization and status as a single-unit or multiple-unit operation (
A geographical information system database containing a listing of businesses throughout the United States provides the establishment inventory for the data collections. FDA samples establishments from the inventory based on the descriptions in table 1. FDA does not intend to sample operations that handle only prepackaged food items or conduct low-risk food preparation activities. The “FDA Food Code” contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted within the operation.
FDA has approximately 25 Retail Food Specialists (Specialists) who serve as the data collectors for the study. A standard form is used by the Specialists during each data collection. The form is divided into three sections: Section 1—“Establishment Information”; Section 2—“Regulatory Authority Information”; and Section 3—“Foodborne Illness Risk Factor and Food Safety Management System Assessment.” The information in Section 1 “Establishment Information” of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions. The information in Section 2 “Regulatory Authority Information” is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment.
Section 3 includes three parts: Part A for tabulating the Specialists' observations of the food employees' behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management system being implemented by the facility; and Part C for assessing the frequency and extent of food employee handwashing. The information in Part A is collected from the Specialists' direct observations of food employee behaviors and practices. Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed. The information in Part B is collected by making direct observations and asking followup questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee handwashing. No questions are asked in the completion of Section 3, Part C of the form.
FDA collects the following information associated with the establishment's identity: establishment name, street address, city, State, ZIP Code, county, industry segment, and facility type. The establishment-identifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected.
The burden associated with the completion of Sections 1 and 3 of Form FDA 3967 is specific to the persons in charge of the selected facilities. The burden includes the time it will take the person in charge to accompany the data collector during the site visit and answer the data collector's questions. The burden related to the completion of Section 2 of the form is specific to the program directors (or designated individuals) of the respective regulatory authorities. This burden includes the time it will take to answer the data collectors' questions and is the same regardless of the facility type. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study.
FDA has collaborated with the Food Protection and Defense Institute to develop a web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. This platform is accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study. FDA estimates the burden of this collection of information as follows:
Based on a review of the information collection since our last request for OMB approval, we have made adjustments to our burden estimate. On our own initiative, however, and for efficiency of Agency operations, we are revising the information collection to include and consolidate related information collection found in 0910-0799. Therefore, our estimated burden for the information collection reflects an increase of 1,401 total burden hours and a corresponding increase of 808 total annual responses.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by April 5, 2024.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports implementation of statutory and regulatory authorities that govern new drugs. Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States unless an approval of an application filed with FDA under section 505(b) or (j) of the FD&C Act is effective with respect to such drug. We have issued regulations in part 314 (21 CFR part 314) that establish procedures and requirements for applications submitted in accordance with section 505 of the FD&C Act. The regulations in subpart A (§§ 314.1 through 314.3) set forth general provisions, while regulations in subparts B and C (§§ 314.50 through 314.99) set forth content and format requirements for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) respectively. The regulations include requirements for the submission of specific data elements along with patent information, pediatric use information, supplements and amendments, proposed labeling, and specific postmarketing reports (PMRs). Respondents to the information collection are sponsors of these applications.
Regulations in subpart D (§§ 314.100 through 314.170) explain Agency actions on applications and set forth timeframes for FDA review. The information collection includes provisions established through our Agency user fee programs, most recently authorized under the FDA User Fee Reauthorization Act of 2022. These provisions pertain to performance goals, expedited programs, review transparency, communications with FDA, dispute resolution, drug safety enhancements, and the allocation of Agency resources to align with these program objectives as agreed to with our stakeholders and set forth in our “User Fee Performance Goals for Fiscal Years 2023-2027” Commitment Letters, which are available from our website at
Included among the provisions in subpart G (§§ 314.410 through 314.445), § 314.420 covers information to include in drug master files (DMFs). To assist respondents to this information collection we have prepared templates, guidance, forms, and resources available from our website at
In accordance with § 314.445, we also develop Agency guidance documents to assist respondents in complying with provisions in part 314. These guidance documents are issued consistent with our good guidance practice regulations at 21 CFR 10.115. To search available FDA guidance documents, visit our website at
Applications submitted in accordance with subpart H (§§ 314.500 through 314.560) pertain to accelerated approval of new drugs for serious or life-threatening illnesses.
Information collection and associated burden for the submissions in subpart I (§§ 314.600 through 314.650) pertain to approval of certain new drugs when human efficacy studies are not ethical or feasible. The regulations provide for the submission of specific data elements, animal studies of safety and efficacy to establish likely clinical benefit in humans and upon approval of the drug product, additional requirements and/or restrictions to ensure safe use of the product. Additional PMRs, safety reporting, and promotional material as well as requirements for withdrawal of these human drug applications, and FDA termination of requirements for these human drug applications are included in §§ 314.620 through 314.650. The estimated burden for these human drug applications is included in the reported submissions and burden under general human drug applications, § 314.50, and other specific regulations in the table for human drug application requirements in general.
Finally, we are also revising the collection to include the submission of information pursuant to the CREATES Act (enacted as part of the Further Consolidated Appropriations Act of 2020 (21 U.S.C. 355-1(1) and 355-2)). Under the CREATES Act, developers of potential drug and biological products are enabled to use the CREATES pathway to obtain samples of brand products that are needed to support their applications. Relevant products include those submitted in generic drug applications under section 505(j) of the FD&C Act and NDAs submitted under
To assist respondents to the information collection we have developed the following forms:
Individuals requesting printed forms are instructed to contact the FDA Forms Manager by email at
Information collection pertaining to hearings and other administrative proceedings covered in 21 CFR subpart E are approved under OMB Control Number 0910-0191. Unless otherwise noted, information collection pertaining to postmarket safety reporting and associated recordkeeping is approved under OMB Control Numbers 0910-0230, and 0910-0291.
Respondents to the information collection are pharmaceutical industry entities who contribute to the preparation and marketing of pharmaceutical products regulated by the FDA.
In the
We estimate the burden of the collection of information as follows:
Our estimated burden for the information collection reflects an overall decrease of 642,293.5 hours. The reporting period for this information collection renewal includes the 3 years of the COVID-19 pandemic. We attribute this adjustment to a decrease in the number of submissions received during the public health emergency. We anticipate that the numbers of submissions to FDA will return to pre-pandemic levels as economic activity recovers. We also attribute a portion of the burden adjustment to improved operational efficiencies with regard to Agency data systems and digital submission processes.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-004, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of jet lag disorder. The decision, which also refuses approval of sNDA 205677-004, is available in the docket identified by the number in the heading of this document.
The decision was published in the docket on March 1, 2024.
Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
On January 31, 2014, FDA approved new drug application (NDA) 205677 for HETLIOZ (tasimelteon) for treatment of non-24-hour sleep-wake disorder, a circadian-rhythm disorder that disproportionately afflicts individuals who are totally blind. On October 16, 2018, Vanda submitted the supplemental NDA (sNDA) that is the subject at issue here: sNDA 205677-004 for HETLIOZ (tasimelteon) capsules, 20 mg, proposing to add a new indication for the treatment of jet lag disorder. On December 1, 2020, FDA approved NDA 214517 for HETLIOZ (tasimelteon) suspension for the treatment of nighttime sleep disturbances in pediatric patients with Smith-Magenis Syndrome, a rare genetic neurodevelopment disorder.
On July 1, 2022, Vanda requested an opportunity for a hearing under 21 CFR 314.110(b)(3) on whether there are grounds under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) for denying approval of sNDA 205677-004 for the treatment of jet lag disorder. On August 29, 2022, CDER notified Vanda by registered mail, providing it with a notice of opportunity for a hearing (NOOH) on a proposal to refuse to approve sNDA 205677-004. The NOOH was subsequently published in the
On November 10, 2022, Vanda filed a notice of participation and requested a hearing and, on December 12, 2022, submitted information, data, and analyses in support of that request. On June 12, 2023, CDER submitted a proposed order denying Vanda's request for a hearing and refusing to approve the sNDA. On August 11, 2023, Vanda responded to CDER's proposed order. On September 8, 2023, CDER submitted a reply, which included a revised proposed order.
After considering the parties' submissions, on March 1, 2024, FDA issued a decision denying Vanda's request for a hearing on CDER's proposal to refuse approval and refusing to approve sNDA 205677-004.
Persons with access to the internet may obtain the final decision at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by April 5, 2024.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports Agency outreach and other proactive communication efforts. Evaluating communication messages and supporting materials in advance of a communication campaign provides an important role in improving FDA communications as they allow for an indepth understanding of individuals knowledge, attitudes, beliefs, motivations, feelings, and behaviors. Such evaluations are critical in helping FDA develop public health communications that meet the needs and desires of its many diverse target audiences.
We intend to use the following methods with general public health consumers and healthcare professionals in our efforts: individual indepth interviews, focus group discussions, intercept interviews, self-administered surveys, and gatekeeper surveys, all on a voluntary basis. The methods to be used serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative and/or quantitative research tools, have two major purposes: (1) to obtain information that is useful for developing variables and measures for formulating the basic objectives of risk communication campaigns and (2) to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. We will use these methods to test and refine our ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.
We will use this qualitative and/or quantitative research to test messages about regulated drug products on a variety of subjects related to consumer, patient, or healthcare professional perceptions and about use of drug products and related materials, including but not limited to: (1) direct-to-consumer prescription drug promotion; (2) labeling and information about prescription and over-the-counter drugs; (3) patient medication guides; (4) safety and risk communications; (5) online sale of medical products; and (6) consumer and professional education. Annually, we project about 75 communication studies using the variety of research methods listed in this document. FDA is requesting an extension of these burden hours so as not to restrict its ability to gather information on public opinion for its regulatory and communications programs.
In the
We estimate the burden of this collection of information as follows:
We have increased our estimated burden to allow for additional individual collections under the approved generic clearance. For more detailed information regarding individual collections conducted under the currently approved generic clearance, please see our supporting statement at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA.
The announcement of the guidance is published in the
You may submit either electronic or written comments on FDA guidances 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:
• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• 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.” We will review this copy, including the claimed confidential information, in our 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 guidance to the Office of Dietary Supplement Programs, HFS-810, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Gerie Voss, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740; or Deirdre Jurand, Office of Regulations and Policy (HFS-024), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
We are announcing the availability of a guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents our current thinking on this topic. 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.
In the
In the
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR 190.6 and found in the guidance have been approved under OMB control number 0910-0330.
Persons with access to the internet may obtain the guidance at
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
CDR George Reed Grimes, Director, Division of Injury Compensation Programs, Health Systems Bureau, HRSA, by mail at 5600 Fishers Lane, 8W25A, Rockville, Maryland 20857; or call (301) 443-9350.
Section 100.2 of the VICP's implementing regulation (42 CFR part 100) states that the revised amount of an average cost of a health insurance policy, as determined by the Secretary of Health and Human Services (the Secretary), is effective upon its delivery by the Secretary to the United States Court of Federal Claims (the Court) and will be published periodically in a notice in the
In 2023, the Medical Expenditure Panel Survey—Insurance Component, available at
Therefore, the Secretary announces that the revised average cost of a health insurance policy under the VICP is $676.78 per month. In accordance with section 100.2, the revised amount was effective upon its delivery by the Secretary to the Court. Such notice was delivered to the Court on February 23, 2024.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Neurological Disorders and Stroke Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, must notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
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
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice at least 10 days in advance of the meeting. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
In the interest of security, NIH has procedures at
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.
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 of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel.
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 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.
U.S. Coast Guard, Department of Homeland Security.
Notice of open Federal advisory committee meetings.
The National Merchant Marine Personnel Advisory Committee (Committee) will conduct a series of meetings over two days in Edmonds, WA to discuss issues relating to personnel in the United States Merchant Marine including the training, qualifications, certification, documentation, and fitness of mariners.
The meetings will be held at Compass Courses, additional information about the facility can be found at:
The National Merchant Marine Personnel Advisory Committee is committed to ensuring all participants have equal access regardless of disability status. If you require reasonable accommodation due to a disability to fully participate, please email Mrs. Megan Johns Henry at
Mrs. Megan Johns Henry, Alternate Designated Federal Officer of the National Merchant Marine Personnel Advisory Committee, telephone (202) 372-1255, or email
Notice of these meetings is in compliance with the
The agenda for the March 26, 2024 meeting is as follows:
(1) The full Committee will meet briefly to discuss subcommittees' business and task statements, which are listed under paragraph (11) under Day 2 below.
(2) During the morning session of the meeting, subcommittees will separately address and work on the following task statements, which are available for viewing at
(a) Task Statement 21-5, Review of Merchant Mariner Rating and Officer Endorsement Job Task Analyses;
(b) Task Statement 21-4, STCW Convention and STCW Code Review; and
(c) Task Statement 21-2, Communication Between External Stakeholders and the Mariner Credentialing Program.
(3) During the afternoon session of the meeting, subcommittees will separately address and work on the following task statements, which are available for viewing at
(a) Task Statement 21-5, Review of Merchant Mariner Rating and Officer Endorsement Job Task Analyses;
(b) Task Statement 21-4, STCW Convention and STCW Code Review; and
(c) Task Statement 22-2, Alternative Methods for Meeting STCW Training Requirements at the Operational Level.
(4) Report of subcommittees. At end of the day, the Chair or Co-Chairs of the subcommittees will report to the full Committee on what was accomplished. The full Committee will not take action on this date and the Chair or Co-Chairs of the subcommittees will present a full report to the Committee on Day 2 of the meeting.
(5) Adjournment of meeting.
The agenda for the March 27, 2024 meeting is as follows:
(1) Introduction.
(2) Designated Federal Officer and U.S. Coast Guard Leadership remarks.
(3) Roll call of Committee members and determination of a quorum.
(4) Adoption of the agenda.
(5) Acceptance of Minutes from Committee Meeting 6 (December 12, 2023).
(6) Introduction of new task.
(7) Homeport demonstration.
(8) Office of Merchant Mariner Credentialing update presentation.
(9) Public comment period.
(10) National Maritime Center update presentation.
(11) Reports from the subcommittee Chair or Co-Chairs.
The Committee will review the information presented on the following Task Statements and deliberate on any recommendations presented by the subcommittees, recommendations may be approved and completed tasks may be closed. Official action on these topics may be taken:
(a) Task Statement 21-1, Review of IMO Model Courses Being Validated by the IMO HTW Subcommittee;
(b) Task Statement 21-2, Communication Between External Stakeholders and the Mariner Credentialing Program, including amendment Task Statement 21-2A, Reviewing Assessments in NVICS for STCW;
(c) Task Statement 21-3, Military Education, Training, and Assessment for STCW and National Mariner Endorsements;
(d) Task Statement 21-4, STCW Convention and Code Review;
(e) Task Statement 21-5, Review of Merchant Mariner Rating and Officer Endorsement Job Task Analyses;
(f) Task Statement 21-6, Sea Service for Merchant Mariner Credential Endorsements;
(g) Task Statement 21-9, Sexual Harassment and Sexual Assault-Prevention and Culture Change in the Merchant Marine;
(h) Task Statement 22-1, Propulsion Power Limits;
(i) Task Statement 22-2, Alternative Methods for Meeting STCW Training Requirements at the Operational Level;
(j) Task Statement 23-2, Critical Skills for Navigation Using Nautical Charts and Training and Assessments of Skills Using Electronic Navigational Charts; and
(k) Task Statement 23-3, Critical Skills for Radar Navigation and Collision Avoidance and Training and Assessment of Skills Using Radar and Automatic Radar Plotting Aids (ARPA).
(12) Closing remarks.
(13) Adjournment of meeting.
A copy of all meeting documentation will be available at
Public comments or questions will be taken throughout the meetings as the Committee discusses the issues, and prior to deliberations and voting. There will also be a public comment period during the meeting on March 27, 2024, at approximately 12:30 p.m. (PDT). Public comments will be limited to 3 minutes per speaker and limited to one comment per person. Please note that the public comments period will end following the last call for comments. Please contact the individual listed in the
Coast Guard, DHS.
Extension of comment period for request for information.
The Coast Guard is extending the comment period of the Request for Information to collect opinions, ideas, recommendations, and concerns related to the Coast Guard's mandate to create planning criteria for vessel response plans (VRPs) distinct to the Western Alaska and Prince William Sound Captain of the Port (COTP) zones. The Coast Guard is tasked with developing planning criteria suitable for operating areas where response capability is currently inadequate.
Comments must be submitted to the online docket via
You may submit comments identified by docket number USCG-2023-0824 using the Federal Decision Making Portal at
For information about this document, call or email Lieutenant Commander Adriana Gaenzle, U.S. Coast Guard; telephone 202-372-1226, email
The U.S. Coast Guard views public participation as essential to understanding vessel oil spill response planning and capabilities in remote areas of Alaska. The Coast Guard will consider all information and material received during the comment period. If you submit a comment, please include the docket number for this request for information, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
The Request for Information was published on December 4, 2023. 88 FR 84157. The original comment period will close on March 4, 2024. However, the Coast Guard has been notified that several stakeholders would like more time to prepare their comments for the Request for Information. The Coast Guard has decided that an extension of the public comment period would be appropriate to allow interested parties additional time to submit comments for Coast Guard's consideration. Thus, Coast Guard is extending the comment period by 60 days, until May 3, 2024.
Office of the Solicitor, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of the Solicitor (SOL) are proposing a new information collection in use without OMB approval.
Interested persons are invited to submit comments on or before May 6, 2024.
Send your comments on this information collection request (ICR) by mail to Ariana Rigsby, 1849 C Street NW, MS 6551, Washington, DC 20240; or by email to
To request additional information about this ICR, contact Ariana Rigsby 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 invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
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 public record. We will include or summarize each comment in our 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 information from public review, we cannot guarantee that we will be able to do so.
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
Bureau of Land Management, Interior.
Notice.
The United States Air Force has requested that the Secretary of the Interior extend the withdrawal established by Public Land Order (PLO) No. 7613 for an additional 20-year term. PLO No. 7613 withdrew 40 acres of public lands from settlement, sale, location, or entry under the general land laws, including the United States mining laws, subject to valid existing rights, for a period of 20 years, to protect a runway safe zone at Nellis Air Force Base located in Las Vegas, Nevada. This notice advises the public of an opportunity to comment on the U.S. Air Force application for extension of the withdrawal and to request a public meeting.
Comments and recommendations for a public meeting regarding the withdrawal extension application must be received on or before June 4, 2024.
Comments and meeting requests should be sent to the Bureau of Land Management (BLM) Las Vegas Field Manager, 4701 North Torrey Pines Dr., Las Vegas, NV 89130.
Eric Benavides, Realty Specialist, BLM Las Vegas Field Office, at (702) 515-5144, email:
The withdrawal established by PLO No. 7613 on August 18, 2004 (69 FR 51320), and serialized as N-74668 (NVNV106080782), is incorporated herein by reference and will expire on August 17, 2024, unless extended as requested by the U.S. Air Force. The purpose of the withdrawal is to protect a runway safe zone at Nellis Air Force Base.
The 40 acres of public lands are located wholly within Nellis Air Force Base, a secured military installation, at the northern end of an active runway; public access to these lands has been restricted since the 1950's. The 40 acres withdrawn by PLO No. 7613 are in the northeast portion of Las Vegas, Nevada, east of Las Vegas Blvd., and are legally described as:
The area described contains 40.00 acres, according to the official plats of the surveys of the said lands, on file with the BLM.
Comments, including name and street address of respondents, will be available for public review at the BLM Las Vegas Field Office, 4701 North Torrey Pines Drive, Las Vegas, Nevada 89130, during regular business hours 8:00 a.m. to 4:00 p.m., Monday through Friday, except holidays.
Before including your address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment—including your personally identifiable information—may be made publicly available at any time. While you may ask the BLM in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so.
Notice is hereby given that an opportunity for a public meeting is afforded in connection with the application for withdrawal extension. All interested persons who desire a public meeting for the purpose of being heard on the application for withdrawal extension must submit a written request to the Field Manager, BLM Las Vegas Field Office, at the address in the
This withdrawal extension application will be processed in accordance with the regulations set forth in 43 CFR 2310.4.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were collected at the Chemawa (Salem) Indian School in Marion County, OR.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, Harvard University, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the PMAE.
Human remains representing, at minimum, one individual was collected at the Chemawa (Salem) Indian School,
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: kinship and anthropological.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate lineal descendants, Indian Tribes, and Native Hawaiian organizations, the PMAE has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Confederated Tribes of Siletz Indians of Oregon.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
This notice was submitted after the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024) but in the older format. As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Michigan History Center has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes in this notice. The human remains and associated funerary objects were removed from Allen County, IN.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after April 5, 2024.
Tobi Voigt, Director of Museums, Michigan History Center, 702 W. Kalamazoo St., Lansing, MI 48915, telephone (517) 243-4041, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Michigan History Center. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Michigan History Center.
Human remains representing, at minimum, one individual were removed from Allen County, IN. On an unknown date in 1912, Joseph Edinger was said to have excavated the burial site of the Miami leader, Little Turtle. A braid of hair with silver buckles was donated to the Michigan History Center. According to the Michigan History Center's records, most of what Edinger excavated from the burial site was said to have been donated to the Smithsonian Museum in Washington, DC, but this is unconfirmed, and no further details are known. The one associated funerary object is one lot of silver buckles.
The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes. The following types of information were used to reasonably trace the relationship: historical information, other relevant information, or expert opinion.
The human remains and associated funerary objects in this notice are connected to an identifiable individual whose descendants can be traced directly and without interruption by means of a traditional kinship system or by the common law system of descendance. The following types of information were used to reasonably trace the relationship: historical information, other relevant information, or expert opinion.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes, the Michigan History Center has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• The one lot of objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a relationship of shared group identity that can be reasonably
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes identified in this notice.
2. Any lineal descendant or Indian Tribe not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the Michigan History Center must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary object are considered a single request and not competing requests. The Michigan History Center is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the New York State Office of Parks, Recreation, & Historic Preservation (NYOPRHP) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Alton, Madison County, IL.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after April 5, 2024.
Jessica Vavrasek, New York State Office of Parks, Recreation & Historic Preservation, Peebles Island State Park, P.O. Box 189, Waterford, NY 12188-0189, telephone (518) 268-2199, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the NYOPRHP. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the NYOPRHP.
In 1876, human remains representing, at minimum, six individuals were removed from Alton in Madison County, IL, by Reverend Robert West. Artifacts recovered from this informal excavation were later transferred to William Letchworth at an unknown point. The 29 associated funerary objects are 27 bones (identified as belonging to a white-tailed deer that represent at least four adults and two immature deer), one whale cervical vertebral body, and one black stone/ceramic pipe stem fragment (approx.10mm in length).
The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: anthropological information, archeological information, and geographical information.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the NYOPRHP has determined that:
• The human remains described in this notice represent the physical remains of six individuals of Native American ancestry.
• The 29 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a relationship of shared group identity that can be reasonably traced between the human remains and associated funerary objects described in this notice and the Peoria Tribe of Indians of Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the NYOPRHP must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The NYOPRHP is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Yager Museum of Art & Culture, Hartwick College (hereafter “Yager Museum”) intends to repatriate a certain cultural item that meets the definition of an object of cultural patrimony and that has a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural item in this notice may occur on or after April 5, 2024.
Dr. Quentin Lewis, Yager Museum of Art & Culture, Hartwick College, 1 Hartwick Drive, Oneonta, NY 13820, telephone (607) 431-4481, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Yager Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
One cultural item has been requested for repatriation. The object is a bear claw necklace, consisting of a small leather thong or strap, which is threaded through punctured holes in each of two bear claws. This necklace was originally in the collection of Townsend Bishop (1867-1950) of Colliersville, NY. It is unclear how Mr. Bishop acquired this necklace. This collection was purchased by Rowan Spraker Sr. of Cooperstown, NY, before joining the Yager Museum's collection in 1963. Museum records indicate that this necklace was made by the Ute, and subsequent research and consultation has supported this affiliation, as well as the culturally patrimonial status of this object to the Ute people.
The Yager Museum has determined that:
•
• There is a reasonable connection between the cultural item described in this notice and the Southern Ute Indian Tribe of the Southern Ute Reservation, Colorado; Ute Indian Tribe of the Uintah & Ouray Reservation, Utah; and the Ute Mountain Ute Tribe.
Additional, written requests for repatriation of the cultural item in this notice must be sent to the Responsible Official identified in
Repatriation of the cultural item in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the Yager Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural item are considered a single request and not competing requests. The Yager Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Milwaukee Public Museum has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Marinette County, WI.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after April 5, 2024.
Dawn Scher Thomae, Milwaukee Public Museum, 800 W Wells Street, Milwaukee, WI 53233, telephone (414) 278-6157, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Milwaukee Public Museum. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Milwaukee Public Museum.
Human remains representing, at minimum, one individual were removed from Marinette County, WI. In 1964, historic burials were excavated at the Potato Rapids site (47-MT-79) located along the Peshtigo River just upstream of the Highway-64 Bridge near the town of Peshtigo and the Potato Rapids power plant in Porterfield Township,
The Potato Rapids Burial site (47-MT-79) is located within the ancestral territory of the Menominee Indian Tribe of Wisconsin and within the area occupied by the Menominee during the early to mid-19th century. According to the Treaty with the Menominee of 1836, a section of land including the site was ceded by the Menominee to the United States Federal Government. Additionally, a map of Indian Villages c. 1830 in the Wisconsin Region of Michigan Territory from Helen Hornbeck Tanner's book, “Atlas of Great Lakes Indian History”, shows several Menominee villages located in the vicinity of the site. In 2000, a burial from the same site was affiliated with and repatriated to the Menominee Indian Tribe of Wisconsin by the Oshkosh Public Museum.
The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical information, historical information, and expert opinion.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Milwaukee Public Museum has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• The 12 objects described in this notice were placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a relationship of shared group identity that can be reasonably traced between the human remains and associated funerary objects described in this notice and the Menominee Indian Tribe of Wisconsin.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the Milwaukee Public Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Milwaukee Public Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at least, 18 individuals have been reasonably identified. No associated funerary objects are present. Human remains representing, at minimum, 15 individuals were collected at the Flandreau Indian School, Moody County, SD. The human remains are hair clippings collected from one individual who was recorded as being 18 years old, one individual who was recorded as being 17 years old, three individuals who were recorded as being 16 years old, five individuals who were recorded as being 15 years old, one individual who was recorded as being 14 years old, three individuals who were recorded as being 13 years old, and one individual who was recorded as being 11 years old and identified as
Human remains representing, at minimum, one individual was collected at the Standing Rock School, Sioux County, ND. The human remains are hair clippings collected from one individual who was recorded as being 36 years old and identified as “Chippewa.” E.D. Mossman took the hair clippings at the Standing Rock School between 1930 and 1933. Mossman sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Human remains representing, at minimum, two individuals were collected at the Cass Lake Chippewa Agency, Cass County, MN. The human remains are hair clippings collected from one individual who was recorded as being 67 years old and one individual who was recorded as being 24 years old and identified as “Chippewa.” M.L. Burns took the hair clippings at the Cass Lake Chippewa Agency between 1930 and 1933. Burns sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of 18 individuals of Native American ancestry.
• There is a reasonable connection between the human remains and associated funerary objects described in this notice and the Minnesota Chippewa Tribe, Minnesota (White Earth Band).
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Mercyhurst University has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from an unknown geographic location in AR.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Anne Marjenin, Mercyhurst University, 501 E 38th Street, Erie, PA 16546, telephone (814) 824-2012, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Mercyhurst University. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by Mercyhurst University.
Human remains representing, at minimum, one individual were removed from an unknown geographic location in AR. The individual (V-MAN-0215) was collected on an unknown date and was obtained by Raymond C. Vietzen (1907-1995). Vietzen, an avocational archeologist, collector, and author, established the Indian Ridge Museum in Elyria, Ohio, and the Archaeological Society of Ohio (formerly the Ohio Indian Relic Collectors Society). The Indian Ridge Museum, founded in the 1930s, served as Vietzen's laboratory and repository, and it remained in operation until the mid-1990s. After Vietzen's death, the facility fell into disrepair, and most of the items he had acquired and housed at the museum were sold. In 1998, the Ohio Historical Society (presently the Ohio History Connection) removed ancestral human remains and some of the remaining items from the facility and temporarily housed them at the Ohio Historical Society. In October of 2003, these human remains were transferred from the Ohio Historical Society to Mercyhurst College (presently Mercyhurst University). No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical and other relevant information.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, Mercyhurst University has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Caddo Nation of Oklahoma.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, Mercyhurst University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. Mercyhurst University is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Tennessee, Department of Anthropology (UTK), has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Jackson County, MO.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Dr. Ozlem Kilic, University of Tennessee, Office of the Provost, 527 Andy Holt Tower, Knoxville, TN 37996-0152, telephone (865) 974-2454, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of UTK. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by UTK.
Sometime before 1968, human remains representing, at minimum, one individual were removed from Fort Osage (23JA45), in Jackson County, MO by an unknown party. Based on a past pattern of practice, it is likely that this individual was transferred to William Bass for analysis, possibly while he was at the University of Kansas, and subsequently brought by him to Knoxville when he began working at UTK in 1971. No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: archaeological information, geographical information, historical information, linguistics, and oral tradition.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, UTK has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and The Osage Nation.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, UTK must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. UTK is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Mercyhurst University has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Anne Marjenin, Mercyhurst University, 501 E 38th Street, Erie, PA 16546, telephone (814) 824-2012, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Mercyhurst University. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by Mercyhurst University.
Human remains representing, at minimum, one individual were removed from Crawford County, AR. The individual (VM-079) was collected on an unknown date and was obtained by Raymond C. Vietzen (1907-1995). Vietzen, an avocational archeologist, collector, and author, established the Indian Ridge Museum in Elyria, Ohio, and the Archaeological Society of Ohio (formerly the Ohio Indian Relic Collectors Society). The Indian Ridge Museum, founded in the 1930s, served as Vietzen's laboratory and repository, and it remained in operation until the mid-1990s. After Vietzen's death, the facility fell into disrepair and most of the items he had acquired and housed at the museum were sold. In 1998, the Ohio Historical Society (presently the Ohio History Connection) removed ancestral human remains and some of the remaining items from the facility and temporarily housed them at the Ohio Historical Society. In October of 2003, these human remains and items were transferred from the Ohio Historical Society to Mercyhurst College (presently Mercyhurst University). No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical, linguistics, and oral tradition.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, Mercyhurst University has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Caddo Nation of Oklahoma and The Osage Nation.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, Mercyhurst University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. Mercyhurst University is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the David Owsley Museum of Art of Ball State University (DOMA) intends to repatriate certain cultural items that meet the definition of sacred objects and objects of cultural patrimony and that have a cultural affiliation with the Indian Tribe identified in this notice.
Repatriation of the cultural items in this notice may occur on or after April 5, 2024.
Chyan Gilaspy, Ball State University, Applied Anthropology Laboratories, 2000 W Riverside Avenue, Muncie, IN 47306, telephone (765) 285-5362, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of DOMA, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of seven cultural items have been requested for repatriation. The sacred objects/objects of cultural patrimony are five basket hats, one basket with a lid, and one basket. The seven cultural items were removed from an unknown county and state, likely originating from Northern California and/or Southern Oregon. In 1983, a private individual donated five of the objects of cultural patrimony/sacred objects (four basket hats, one basket with lid) to DOMA. These are identified by DOMA catalog numbers 1983.006.003, 1983.006.004a, 1983.006.004b, 1983.006.005a-b, and 1983.006.059. In 2018, the estate of a private individual bequeathed two of the objects of cultural patrimony/sacred objects (one basket hat and one basket) to DOMA. These are identified by DOMA catalog numbers 2018.052.022 and 2018.052.024. No information is available for any of the objects concerning the dates of creation, donor
DOMA has determined that:
• The seven sacred objects/objects of cultural patrimony described in this notice are, according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization, specific ceremonial objects needed by a traditional Native American religious leader for present-day adherents to practice traditional Native American religion, and have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision).
• There is a reasonable connection between the cultural items described in this notice and the Resighini Rancheria, California.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, DOMA must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The DOMA is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of California, Berkeley has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Morrow County, OR.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Alexandra Lucas, Repatriation Coordinator, Government and Community Relations (Chancellor's Office), University of California, Berkeley, 200 California Hall, Berkeley, CA 94720, telephone (510) 570-0964, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the University of California, Berkeley. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the University of California, Berkeley.
Human remains representing, at minimum, two individuals were removed from two known locations in Morrow County, Eastern Oregon (designated OR-Morrow-NL-1 and OR-Morrow-NL-2) before 1940, and donated to the Lowie Museum (Phoebe A. Hearst Museum of Anthropology) by Mr. Bentley Wells. No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: Tribal traditional knowledge, geographical, anthropological, archaeological, kinship, biological, linguistic, folklore, historical, and oral history.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the University of California, Berkeley has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Confederated Tribes of the Umatilla Indian Reservation; Confederated Tribes of the Warm Springs Reservation of Oregon; and the Nez Perce Tribe.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the University of California, Berkeley must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The University of California, Berkeley is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
This notice was submitted after the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024) but in the older format. As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Land Management, Winnemucca District Office has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Washoe County, NV.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Cedric Streater, Bureau of Land Management, 5100 E. Winnemucca Boulevard, Winnemucca, NV 89445, telephone (775) 623-1595, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Winnemucca District Office. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the Winnemucca District Office.
Human remains representing, at minimum, five individuals were removed from Washoe County, NV. The human remains consisted of five incomplete individuals: one adult male; one young adult male approximately 20-35 years old; one young adult male; one youth, possibly male, approximately 15-20 years old; and one child. These human remains were originally cataloged by the Hearst Museum under Accession 1030 and their catalog number is 12-8369. At the request of the Pyramid Lake Paiute Tribe, these human remains were transferred to the Nevada State Museum (NSM) in 2012. The NSM catalog numbers for the human remains are AHUR 6019 through 6023.
The Bureau of Land Management recently became aware of Native American human remains collected prior to November 16, 1990, on lands administered by the BLM. The human remains were reported as culturally unidentifiable on June 19, 2003, by the Phoebe A. Hearst Museum of Anthropology (Hearst Museum). In November 2011, the BLM became aware of previously unreported Native American human remains through a letter from the Pyramid Lake Paiute Tribe requesting BLM involvement in assisting with the repatriation of remains being held at the Hearst Museum. The remains were collected sometime in 1947-1948 near Winnemucca Lake Caves in Nevada and received by the Hearst Museum in 1948. According to the records of the Hearst Museum, this material was reported in their Washoe County Inventory, dated June 28, 2000. In a closer review of the locality documentation, it was determined the material is under the control of the BLM.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: geographical information and expert opinion.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the Winnemucca District Office has determined that:
• The human remains described in this notice represent the physical remains of five individuals of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains and associated funerary objects described in this notice and the Bishop Paiute Tribe; Bridgeport Indian Colony; Burns Paiute Tribe; Cedarville Rancheria, California; Confederated Tribes of the Warm Springs Reservation of Oregon; Fort Bidwell Indian Community of the Fort Bidwell Reservation of California; Fort Independence Indian Community of Paiute Indians of the Fort Independence Reservation, California; Fort McDermitt Paiute and Shoshone Tribes of the Fort McDermitt Indian Reservation, Nevada and Oregon; Klamath Tribes; Lone Pine Paiute-Shoshone Tribe; Lovelock Paiute Tribe of the Lovelock Indian Colony, Nevada; Paiute-Shoshone Tribe of the Fallon Reservation and Colony, Nevada; Pyramid Lake Paiute Tribe of the Pyramid Lake Reservation, Nevada; Reno-Sparks Indian Colony, Nevada; Shoshone-Paiute Tribes of the Duck Valley Reservation, Nevada; Summit Lake Paiute Tribe of Nevada; Susanville Indian Rancheria, California; Battle Mountain Band, Nevada; Te-Moak Tribe of Western Shoshone Indians of Nevada (Battle Mountain Band); Utu Utu Gwaitu Paiute Tribe of the Benton Paiute Reservation, Nevada; Walker River Paiute Tribe of the Walker River Reservation, Nevada; Winnemucca Indian Colony of Nevada; and the Yerington Paiute Tribe of the Yerington Colony & Campbell Ranch, Nevada.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the Winnemucca District Office must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The Winnemucca District Office is responsible for sending a copy of this notice to the Indian Tribes and Native
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the General Services Administration, Pacific Rim Region, Design & Construction Division (GSA), intends to carry out the disposition of human remains removed from Federal lands to the Native Hawaiian organization with priority for disposition in this notice.
Disposition of the human remains in this notice may occur on or after April 5, 2024. If no claim for disposition is received by March 6, 2025, the human remains in this notice will become unclaimed human remains.
Jason Hagin, Regional Historic Preservation Officer, Design & Construction Division, 50 United Nations Plaza, MB9, Room 3411, San Francisco, CA 94102, telephone (415) 244-7760, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of GSA, and additional information on the human remains in this notice, including the results of consultation, can be found in the related records. The National Park Service is not responsible for the identifications in this notice.
Based on the information available, fragments of human remains representing an unknown number of individuals have been reasonably identified. No associated funerary objects are present. No unassociated funerary objects, sacred objects, or objects of cultural patrimony are present
GSA has determined that:
• The fragments of human remains described in this notice do not reflect an intact burial site and represent the physical remains of an unknown number of individuals of Native Hawaiian ancestry.
• `Ohana Keaweamahi has priority for disposition of the human remains described in this notice.
Written claims for disposition of the human remains in this notice must be sent to the appropriate official identified in this notice under
1. Any lineal descendant or Native Hawaiian organization identified in this notice.
2. Any lineal descendant or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that they have priority for disposition.
Disposition of the human remains in this notice may occur on or after April 5, 2024. If competing claims for disposition are received, GSA must determine the most appropriate claimant prior to disposition. Requests for joint disposition of the human remains are considered a single request and not competing requests. GSA is responsible for sending a copy of this notice to the lineal descendants and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of Defense, Defense Health Agency, National Museum of Health and Medicine has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Jackson County, AL; Christian County, KY; McLean County, KY; Ohio County, KY; Union County, KY; Hamilton County, TN; Sevier County, TN; and Kanawha County, WV.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Mr. Brian F. Spatola, Curator of Anatomical Division, National Museum of Health and Medicine, U.S. Army Garrison Forest Glen, 2500 Linden Lane, Silver Spring, MD 20910, telephone (301) 319-3353, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the National Museum of Health and Medicine. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by the National Museum of Health and Medicine.
Human remains representing, at minimum, two individuals were removed from Jackson County, AL. The human remains consist of a humerus removed from the Garland's Ferry site, and a femur and humerus removed from the William's Landing site by Clarence B. Moore. The human remains were donated to the Army Medical Museum (today the National Museum of Health
Human remains representing, at minimum, one individual were removed from Christian County, KY. The human remains consist of a cranium with no known collection history. “MCR-64/Chr. Co, KY” and “KY-1964” are written on the cranium in black ink. The human remains were donated to the National Museum of Health and Medicine in 2003. No associated funerary objects are present.
Human remains representing, at minimum, two individuals were removed from McLean County, KY. The remains consist of a femur and tibia removed from the Austin Place site, and a radius removed from the Calhoun site by Clarence B. Moore. The human remains were donated to the Army Medical Museum by Clarence B. Moore in April 1916. No associated funerary objects are present.
Human remains representing, at minimum, 12 individuals were removed from Ohio County, KY. The human remains consist of multiple skeletal elements removed from the Indian Knoll site by Clarence B. Moore. The human remains were donated to the Army Medical Museum by Clarence B. Moore in 1916. No associated funerary objects are present.
Human remains representing, at minimum, one individual were removed from Union County, KY. The human remains consist of a partial cranium that was collected by Sydney S. Lyon. Initially, these human remains were donated to the Smithsonian Institution. In January 1870, they were transferred to the Army Medical Museum. No associated funerary objects are present.
Human remains representing, at minimum, four individuals were removed from Hamilton County, TN. The human remains consist of a tibia removed from Hampton Place at Moccasin Bend, and an ulna, radius, and two tibiae removed from the Citico Mound site by Clarence B. Moore. The human remains were donated to the Army Medical Museum by Clarence B. Moore in 1915. No associated funerary objects are present.
Human remains representing, at minimum, three individuals were removed from Sevier County, TN. The human remains consist of a sternum, fibula, and tibia removed from McMahan Mound by E. Palmer in 1881. Initially, these human remains were donated to the Smithsonian Institution. In July 1886, they were transferred to the Army Medical Museum. No associated funerary objects are present.
Human remains representing, at minimum, one individual were removed from Kanawha County, WV. The human remains consist of a tibia removed from Smith's Farm near Charleston by P. W. Norris. Initially, these human remains were donated to the Smithsonian Institution. In 1904, they were transferred to the Army Medical Museum. No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: anthropological information, geographical information, and historical information.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, the National Museum of Health and Medicine has determined that:
• The human remains described in this notice represent the physical remains of 26 individuals of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Cherokee Nation; Eastern Band of Cherokee Indians; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the National Museum of Health and Medicine must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The National Museum of Health and Medicine is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Army Corps of Engineers, St. Louis District, intends to carry out the disposition of human remains, associated funerary objects, unassociated funerary objects, sacred objects, or objects of cultural patrimony removed from Federal or Tribal lands to the lineal descendants, Indian Tribe, or Native Hawaiian organization with priority for disposition in this notice.
Disposition of the human remains or cultural items in this notice may occur on or after April 5, 2024. If no claim for disposition is received by March 6, 2025, the human remains or cultural items in this notice will become unclaimed human remains or cultural items.
Jenna Domeischel, U.S. Army Corps of Engineers, St. Louis District, 1222 Spruce Street, ATTN:
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the U.S. Army Corps of Engineers, St. Louis District, and additional information on the human remains or cultural items in this notice, including the results of consultation, can be found in the related records. The National Park Service is not responsible for the identifications in this notice.
The 55 associated funerary objects are two lots of soil, 41 ceramics, two shell fragments, seven lithics, one groundstone, and two small rocks. In July 2017, human remains and associated funerary objects were discovered at Mark Twain Lake, Monroe County, Missouri, by a member of the public. These remains and one associated funerary object were previously reported in a newspaper notice in 2023 (
The U.S. Army Corps of Engineers, St. Louis District, has determined that:
• The 55 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• The U.S. Army Corps of Engineers, St. Louis District, has identified The Osage Nation as having priority for disposition of the cultural items described in this notice.
Written claims for disposition of the human remains or cultural items in this notice must be sent to the appropriate official identified in this notice under
1. Any lineal descendant, Indian Tribe, or Native Hawaiian organization identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that they have priority for disposition.
Disposition of the human remains or cultural items in this notice may occur on or after April 5, 2024. If competing claims for disposition are received, the U.S. Army Corps of Engineers, St. Louis District, must determine the most appropriate claimant prior to disposition. Requests for joint disposition of the human remains or cultural items are considered a single request and not competing requests. The U.S. Army Corps of Engineers, St. Louis District, is responsible for sending a copy of this notice to the lineal descendants, Indian Tribes, and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Peabody Museum of Archaeology and Ethnology, Harvard University (PMAE) has completed an inventory of human remains and has determined that there is a known lineal descendant connected to the human remains in this notice.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Jane Pickering, Peabody Museum of Archaeology and Ethnology, 11 Divinity Avenue, Cambridge, MA 02138, telephone (617) 496-2374, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the PMAE, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, one individual have been reasonably identified. No associated funerary objects are present. The human remains were collected at the Sherman Institute, Riverside County, CA, and are hair clippings collected from one individual, Rudolph Aguilar, who was recorded as being 18 years old and identified as “Mission.” Samuel H. Gilliam took the hair clippings at the Sherman Institute between 1930 and 1933. Gilliam sent the hair clippings to George Woodbury, who donated the hair clippings to the PMAE in 1935. No associated funerary objects are present.
Based on the information available and the results of consultation, a lineal descendant is connected to the human remains described in this notice.
The PMAE has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• A known lineal descendant Michelle Aguilar-Wells is connected to the human remains described in this notice.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. The known lineal descendant connected to the human remains.
2. Any other lineal descendant not identified who shows, by a preponderance of the evidence, that the requestor is a lineal descendant.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the PMAE must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The PMAE is responsible for sending a copy of this notice to the lineal descendant and the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Gilcrease Museum has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after April 5, 2024.
Laura Bryant, Gilcrease Museum, 800 S Tucker Drive, Tulsa, OK 74104, telephone (918) 596-2747, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Gilcrease Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at least, one individual has been reasonably identified. The 24 associated funerary objects are 19 lots of lithic tools, one lot of faunal remains, two shell cups, one lot of shell and copper beads, and one lot of sherds. Frank Soday, an avocational archaeologist, from “Grave Island” in Limestone County, AL in 1951. Gilcrease Museum acquired Soday's collection in 1982.
Based on the information available, human remains representing, at least, one individual has been reasonably identified. The 33 associated funerary objects are one lot of sherds and 32 lots of lithic tools. Frank Soday, an avocational archaeologist, from “Peninsula West of Chemstrand Point” in Morgan County, AL in 1952. Gilcrease Museum acquired Soday's collection in 1982.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location of the human remains and associated funerary objects described in this notice.
The Gilcrease Museum has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• The 57 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the human remains and associated funerary objects described in this notice and the Cherokee Nation; Eastern Band of Cherokee Indians; The Chickasaw Nation; The Muscogee (Creek) Nation; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the Gilcrease Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The Gilcrease Museum is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Central Washington University has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Klickitat County, WA.
Repatriation of the human remains in this notice may occur on or after April 5, 2024.
Lourdes Henebry-DeLeon, Department of Anthropology and Museum Studies, Central Washington University, 400 University Way, Ellensburg, WA 98926-7544, telephone (509) 963-2671, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Central Washington University. The National Park Service is not responsible for the determinations in this notice. Additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records held by Central Washington University.
Human remains representing, at minimum, one individual were removed from Yakima County, WA. The Yakima County Coroner's Office found the human remains in 2000 or 2001 and subsequently donated them to Central Washington University. The Coroner's Office has no information about their origins. The King County Medical Examiner's Forensic Anthropologist determined the human remains to be non-forensic. No associated funerary objects are present.
The human remains in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of shared group identity between the identifiable earlier groups, tribes, peoples, or cultures and one or more Indian Tribes or Native Hawaiian organizations. The following types of information were used to reasonably trace the relationship: biological, geographical, historical, and expert opinion.
Pursuant to NAGPRA and its implementing regulations, and after consultation with the appropriate Indian Tribes and Native Hawaiian organizations, Central Washington University has determined that:
• The human remains described in this notice represent the physical remains of one individuals of Native American ancestry.
• There is a relationship of shared group identity that can be reasonably traced between the human remains described in this notice and the Confederated Tribes and Bands of the Yakama Nation.
Written requests for repatriation of the human remains in this notice must be sent to the Responsible Official identified in
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, Central Washington University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. Central Washington University is responsible for sending a copy of this notice to the Indian Tribe identified in this notice.
This notice was submitted before the effective date of the revised regulations (88 FR 86452, December 13, 2023, effective January 12, 2024). As the notice conforms to the mandatory format of the
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Gilcrease Museum intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after April 5, 2024.
Laura Bryant, Gilcrease Museum, 800 S Tucker Drive, Tulsa, OK 74104, telephone (918) 596-2747, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Gilcrease Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of two cultural items have been requested for repatriation. The two objects of cultural patrimony are a robe and a mat. J.A. Wyrick and Frank Weddington removed these items from Piney Creek Bluff Shelter in Carroll County, AR in 1935. Harry Lemley acquired these from them later that same year. Thomas Gilcrease purchased Lemley's collection, including these items, in 1950, and Gilcrease transferred his collection to the City of Tulsa in 1955.
A total of one cultural item has been requested for repatriation. The one object of cultural patrimony is a bald cypress pole fragment. James Porter removed the item from the Mitchell Mound site in Madison County, Illinois in the 1960s. Gilcrease Museum acquired the item shortly after.
The Gilcrease Museum has determined that:
• The three objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and The Osage Nation.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after April 5, 2024. If competing requests for repatriation are received, the Gilcrease Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Gilcrease Museum is responsible for sending a
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on January 30, 2024, under section 337 of the Tariff Act of 1930, as amended, on behalf of PAX Labs Inc. of San Francisco, California. Supplements were filed on February 19, 2024, February 20, 2024, and February 21, 2024. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain oil vaporizing devices, components thereof, and products containing the same by reason of the infringement of certain claims of U.S. Patent No. 11,369,756 (“the '756 patent”); U.S. Patent No. 11,369,757 (“the '757 patent”); U.S. Patent No. 11,766,527 (“the '527 patent”); 11,759,580 (“the '580 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and a cease and desist order.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Katherine Hiner, The Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-3, 5-13, and 15-17 of the '756 patent; claims 1-20 of the '757 patent; claims 1-30 of the '527 patent; and claims 1-20 of the '580 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “vaporizing devices capable of vaporizing oils, components thereof and products containing the same” where the components of a vaporizing device are “a mouthpiece, a cartridge body, an atomizer, a distal member, a bottom cover, a vaporizer body including a cartridge receiver,” as well as a “battery,” and where products containing the same are cartridge and battery components “sold in combination with a power charging device in which the [cartridge] or battery would each be one component of the downstream product”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is:
(b) The respondents are the following entities alleged to be in violation of section 337, and is the parties upon which the complaint is to be served:
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not be a party to this investigation.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-693 and 731-TA-1629-1640 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of mattresses, provided for in subheadings 9404.21.00, 9404.29.10, and 9404.29.90 of the Harmonized Tariff Schedule of the United States, from Bosnia and Herzegovina, Bulgaria, Burma, India, Italy, Kosovo, Mexico, Philippines, Poland, Slovenia, Spain, and Taiwan preliminarily determined by the Department of Commerce (“Commerce”) to be sold at less than fair value and imports of mattresses from Indonesia for which Commerce has preliminarily determined that countervailable subsidies are not being provided by the Government of Indonesia to producers and exporters of mattresses from Indonesia.
March 1, 2024.
Mary Messer ((202) 205-3193), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
The products covered by these investigations are all types of youth and adult mattresses. The term “mattress” denotes an assembly of materials that at a minimum includes a “core,” which provides the main support system of the mattress, and may consist of innersprings, foam, other resilient filling, or a combination of these materials. Mattresses also may contain: (1) “upholstery,” the material between the core and the top panel of the ticking on a single-sided mattress, or between the core and the top and bottom panel of the ticking on a double-sided mattress; and/or (2) “ticking,” the outermost layer of fabric or other material (
For further information concerning the conduct of this phase of the investigations, hearing procedures, and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
Although Commerce has preliminarily determined that countervailable subsidies are not being provided by the Government of Indonesia to producers and exporters of mattresses from Indonesia, for purposes of efficiency the Commission hereby waives rule 207.21(b)
Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference, if deemed necessary, to be held at 9:30 a.m. on May 7, 2024. Parties shall file and serve written testimony and presentation slides in connection with their presentation at the hearing by no later than 4:00 p.m. on May 8, 2024. Oral testimony and written materials to be submitted at the public hearing are governed by sections 201.6(b)(2), 201.13(f), and 207.24 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony
Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
United States International Trade Commission.
Notice of investigation and scheduling of a public hearing.
Following receipt on February 5, 2024, of a request from the U.S. House of Representatives Committee on Ways and Means (Committee) under section 332(g) of the Tariff Act of 1930, the U.S. International Trade Commission (Commission) instituted Investigation No. 332-603,
April 8, 2024: Deadline for filing requests to appear at the public hearing.
April 11, 2024: Deadline for filing prehearing briefs and statements.
April 22, 2024: Deadline for filing electronic copies of oral hearing statements.
April 30, 2024: Public hearing.
May 22, 2024: Deadline for filing posthearing briefs.
July 12, 2024: Deadline for filing all other written submissions.
March 5, 2025: Transmittal of Commission report to the Committee.
All Commission offices, including the Commission's hearing rooms, are located in the U.S. International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions should be addressed to the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. The public record for this investigation may be viewed on the Commission's
Project Leader Renee Berry (202-205-3498 or
• information on recent developments in the rice industries in the United States and other major global producing and exporting countries, such as Bangladesh, Brazil, China, India, Indonesia, Pakistan, Paraguay, Thailand, Uruguay, and Vietnam;
• information on recent trade trends and developments in the global market for rice, including U.S. and major foreign supplier imports and exports;
• a comparison of the competitive strengths and weaknesses of rice production in and exports from the United States and other major exporting countries, focusing on factors affecting delivered cost, product differentiation, and reliability of supply, as well as government policies and programs that directly or indirectly affect rice production and exporting in these countries;
• a qualitative and, to the extent possible, quantitative assessment of the impact of government policies and programs, including public stockholding programs and export restrictions, of major producing and exporting countries on U.S. rice production, product revenues and profits, consumption, trade, and prices, as well as on food security in developing countries; and
• an overview of the impact on the U.S. rice industry of exports of rice from the highlighted countries to the United States and to traditional export markets of the United States.
As requested by the Committee, the Commission will deliver the report no later than March 5, 2025. The Committee asked that the Commission not include confidential business or national security classified information in its report. However, as detailed below, participants may submit confidential information to the Commission to inform its understanding of these issues, and such information will be protected in accordance with the Commission's
Requests to appear at the hearing should be filed with the Secretary to the Commission no later than 5:15 p.m., April 8, 2024, in accordance with the requirements in the “Written Submissions” section below. Any requests to appear as a witness via videoconference must be included with your request to appear. Requests to appear as a witness via videoconference must include a statement explaining why the witness cannot appear in person; the Chairman, or other person designated to conduct the investigation, may at their discretion for good cause shown, grant such requests. Requests to appear as a witness via videoconference due to illness or a positive COVID-19 test result may be submitted by 3 p.m. the business day prior to the hearing.
All prehearing briefs and statements should be filed no later than 5:15 p.m., April 11, 2024. To facilitate the hearing, including the preparation of an accurate written public transcript of the hearing, oral testimony to be presented at the hearing must be submitted to the Commission electronically no later than noon, April 22, 2024. All posthearing briefs and statements should be filed no later than 5:15 p.m., May 22, 2024. Posthearing briefs and statements should address matters raised at the hearing. For a description of the different types of written briefs and statements, see the “Definitions” section below. In the event that, as of the close of business on April 8, 2024, no witnesses are scheduled to appear at the hearing, the hearing will be canceled. Any person interested in attending the hearing as an observer or nonparticipant should check the Commission website as indicated above for information concerning whether the hearing will be held.
(1)
(2)
(3)
(4)
In accordance with the provisions of section 201.8 of the Commission's Rules of Practice and Procedure (19 CFR 201.8) the document must identify on its cover (1) the investigation number and title and the type of document filed (
As requested by the Committee, the Commission will not include any CBI in its report. However, all information, including CBI, submitted in this investigation may be disclosed to and used by: (i) the Commission, its employees and offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission, including under 5 U.S.C. Appendix 3; or (ii) U.S. Government employees and contract personnel for cybersecurity purposes. The Commission will not otherwise disclose any CBI in a way that would reveal the operations of the firm supplying the information.
By order of the Commission.
Drug Enforcement Administration, Justice.
Notice of application.
AndersonBrecon Inc. dba PCI Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 5, 2024. Such persons may also file a written request for a hearing on the application on or before April 5, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on September 29, 2023, AndersonBrecon Inc. dba PCI Pharma Services, 5775 Logistics Parkway, Rockford, Illinois 61109-3608, applied
The company plans to import the listed controlled substances for clinical trials. No other activities for these drug codes are authorized for this registration. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Sigma Aldrich Company LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 5, 2024. Such persons may also file a written request for a hearing on the application on or before April 5, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on February 7, 2024, Sigma Aldrich Company LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118-4103, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. In reference to drug code 7370 (Tetrahydrocannabinols) the company plans to import synthetic Tetrahydrocannabinols. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Sterling Pharma USA LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 6, 2024. Such persons may also file a written request for a hearing on the application on or before May 6, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on January 9, 2024, Sterling Pharma USA LLC., 10001 Sheldon Drive, Suite 101, Cary, North Carolina 27513, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to manufacture the above-listed controlled substance(s) to support clinical trials. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Stepan Company has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 6, 2024. Such persons may also file a written request for a hearing on the application on or before May 6, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on January 26, 2024, Stepan Company, 100 West Hunter Avenue, Maywood, New Jersey 07607-1021, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture the listed controlled substances for use as internal intermediates or for sale to its customers. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 6, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may submit electronic comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical ingredients for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place.
As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that on June 13, 2022, Nusachi Labs, LLC, 2909 Armory Drive, Nashville, Tennessee 37204, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
Drug Enforcement Administration, Justice.
Notice of application.
Benuvia Operations, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 5, 2024. Such persons may also file a written request for a hearing on the application on or before April 5, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on February 6, 2024, Benuvia Operations, LLC, 3950 North Mays Street, Round Rock, Texas 78665-2729, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substances for clinical trial manufacturing and analytical purposes. sale to research facilities for drug testing and analysis. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Organic Consultants LLC DBA Cascade Chemistry has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 6, 2024. Such persons may also file a written request for a hearing on the application on or before May 6, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on January 24, 2024, Organic Consultants LLC DBA Cascade Chemistry, 90 North Polk Street, Suite 200, Eugene, Oregon 97402-4109, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture small quantities of the listed controlled substances for internal use or for sale as analytical reference standard materials to its customers. No other activities for these drug codes are authorized for this registration.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Veterans' Employment and Training Service (VETS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before April 5, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Wilson Vadukumcherry by telephone at 202-693-0110, or by email at
The information collections under OMB Control No. 1293-0016 provides to place job assistance counselors (Employment Navigators) on select military bases to assist transitioning service members move into the civilian labor force. Employment Navigators will assist transitioning service members to get placed on a best-fit pathway for his/her desired career. In order to create return on investment metrics, data must be collected on the services provided by Employment Navigators, and employment-based outcomes that follow. Data is expected to be collected directly from Employment Navigators assisting transitioning service members, as well as any DOL-approved service partners who also provided job-assistance services to the service members. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Fire Protection in Shipyard Employment Standard.
Comments must be submitted (postmarked, sent, or received) by May 6, 2024.
For further information on submitting comments, see the “Public Participation” heading in the section of this notice titled
Seleda Perryman, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor; telephone (202) 693-2222.
The Department of Labor, as part of the continuing effort to reduce paperwork and respondent (
The Fire Protection in Shipyard Employment Standard specifies a number of information collection requirements. In general, the standard requires employers to develop a written fire safety plan covering elements that identify the potential fire risk hazards and procedures for reporting these hazards, employers to create, maintain, and update a written policy that describes the internal and outside fire response organizations that the employer will use, and employers to notify employees and take the necessary precautions to make sure employees are safe from fire if for any reason a fire extinguishing system stops working. The standard also requires the employer to obtain medical exams for certain workers and to create and maintain records to certify that employees have been made aware of the details of the fire safety plan and that employees have been trained as required by the standard.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions to protect workers, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information, and transmission techniques.
OSHA is requesting that OMB extend the approval of the information collection requirements specified in the Fire Protection in Shipyard Employment Standard. The agency is requesting an adjustment decrease in burden from 16,251 to 15,972 hours, a difference of 279 hours. This decrease in burden is due to the decrease in the number of affected workers and in the number of establishments.
OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.
You may submit comments in response to this document as follows: (1) electronically at
Comments and submissions are posted without change at
James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
National Credit Union Administration (NCUA).
Notice and request for comments.
The National Credit Union Administration (NCUA) will submit the following information collection requests 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.
Written comments should be received on or before May 6, 2024 to be assured consideration.
Interested persons are invited to submit written comments on the information collection to Mahala Vixamar, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314, Suite 5067; Fax No. 703-519-8579; or Email at
Copies of the submission may be obtained by contacting Mahala Vixamar at (703) 718-1155.
By the National Credit Union Administration Board.
National Endowment for the Humanities; National Foundation on the Arts and the Humanities.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the National Council on the Humanities will meet to advise the Chair of the National Endowment for the Humanities (NEH) with respect to policies, programs and procedures for carrying out her functions; to review applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965 and make recommendations thereon to the Chair; and to consider gifts offered to NEH and make recommendations thereon to the Chair.
The meeting will be held on Thursday, March 14, 2024, from 1 p.m. until 4:30 p.m., and Friday, March 15, 2024, from 1 p.m. until adjourned.
The meeting will be held by videoconference originating at Constitution Center, 400 7th Street SW, Washington, DC 20506.
Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, 4th Floor, Washington, DC 20506; (202) 606-8322;
The National Council on the Humanities is meeting pursuant to the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951-960, as amended).
The following Committees of the National Council on the Humanities will convene by videoconference on March 14, 2024, from 1 p.m. until 3:20 p.m., to discuss specific grant
Research Programs; Preservation and Access; Education Programs; Public Programs; Digital Humanities; Data and Evaluation; Challenge Programs; and Federal/State Partnership.
The National Council will then convene in executive session by videoconference on March 14, 2024, from 3:30 p.m. until 4:30 p.m.
The plenary session of the National Council on the Humanities will convene by videoconference on March 15, 2024, at 1 p.m. The agenda for the plenary session will be as follows:
This meeting of the National Council on the Humanities will be closed to the public pursuant to sections 552b(c)(4), 552b(c)(6), and 552b(c)(9)(B) of title 5 U.S.C., as amended, because it will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, and discussion of certain information, the premature disclosure of which could significantly frustrate implementation of proposed agency action. I have made this determination pursuant to the authority granted me by the Chair's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.
National Intelligence University (NIU), Office of the Director of National Intelligence (ODNI).
Notice of Federal Advisory Committee meeting of the National Intelligence University Board of Visitors.
ODNI is publishing this notice to announce that the following Federal Advisory Committee meeting of the NIU Board of Visitors (BoV) will take place. This meeting is closed to the public.
Thursday, 28 March, 8:30 a.m. to 5 p.m., Bethesda, MD.
National Intelligence University, 4600 Sangamore Road, Bethesda, MD 20816.
Ms. Patricia “Patty” Larsen, Designated Federal Officer, (301) 243-2118 (Voice),
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. 1001-1014), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.140 and 102-3.150. The meeting includes the discussion of classified information and classified materials regarding intelligence education issues, internal personnel rules and practices of NIU, and pre-decisional strategic planning matters; and the Director of National Intelligence, or her designee, in consultation with the ODNI Office of General Counsel, has determined the meeting will be closed to the public under the exemptions set forth in 5 U.S.C. 552b(c)(1),552b(c)(2), and 552b(c)(9)(B).
Week of March 4, 2024.
Via Teleconference.
Open.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is requesting comment on a draft Programmatic Agreement (PA) between the NRC, Pennsylvania State Historic Preservation Office (SHPO), and TMI-2 Energy Solutions (TMI-2
Submit comments by April 5, 2024. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods; however, the NRC encourages electronic comment submission through the Federal rulemaking website:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Jean Trefethen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-0867; email:
Please refer to Docket ID NRC-2024-0050 when contacting the NRC about the availability of information regarding this action. You may obtain publicly available information related to this action by the following methods:
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The NRC encourages electronic comment submission through the Federal Rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment
By letter dated February 22, 2023 (ADAMS Accession No. ML23058A064), TMI-2
The NRC uses its National Environmental Policy Act process for developing environmental assessments (EAs) to facilitate consultation under section 106 of the National Historic Preservation Act (NHPA), pursuant to 36 CFR 800.8.
The NRC met with the Advisory Council on Historic Preservation, the Pennsylvania State Historic Preservation Officer (SHPO), TMI-2
The draft PA addresses the potential direct and indirect adverse effects from the decommissioning activities and ensures that appropriate mitigation measures are implemented. The NRC's final EA will include the final PA and therefore conclude NHPA section 106 consultation.
The NRC is requesting public comment on the draft PA. The NRC will consider these comments before finalizing the PA, which will be published as an appendix in the final EA. The draft PA is available in ADAMS under Accession No. ML24044A184.
For the Nuclear Regulatory Commission.
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.
1.
This Notice will be published in the
In accordance with the requirement of section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad
Under section 2 of the Railroad Retirement Act (45 U.S.C. 231a), dependency on an employee for one-half support at the time of the employee's death can affect (1) entitlement to a survivor annuity when the survivor is a parent of the deceased employee; (2) the amount of spouse and survivor annuities; and (3) the Tier II restored amount payable to a widow(er) whose annuity was reduced for receipt of an employee annuity, and who was dependent on the railroad employee in the year prior to the employee's death. One-half support may also negate the public service pension offset in Tier I for a spouse or widow(er). The Railroad Retirement Board (RRB) utilizes Form G-134, Statement Regarding Contributions and Support, to secure information needed to adequately determine if the applicant meets the one-half support requirement. One response is completed by each respondent. Completion is required to obtain benefits. The RRB proposes a minor editorial changes to Form G-134 to change the date under section 1 “General Instructions”.
Under section 10 of the Railroad Retirement Act and section 2(d) of the Railroad Unemployment Insurance Act (45 U.S.C. 231i), the RRB may recover overpayments of annuities, pensions, death benefits, unemployment benefits, and sickness benefits that were made erroneously. An overpayment may be waived if the beneficiary was not at fault in causing the overpayment and recovery would cause financial hardship. The regulations for the recovery and waiver of erroneous payments are contained in 20 CFR 255 and CFR 340.
The RRB utilizes Form DR-423, Financial Disclosure Statement, to obtain information about the overpaid beneficiary's income, debts, and expenses if that person indicates that (s)he cannot make restitution for the overpayment. The information is used to determine if the overpayment should be waived as wholly or partially uncollectible. If waiver is denied, the information is used to determine the size and frequency of installment payments. The beneficiary is made aware of the overpayment by letter and is offered a variety of methods for recovery. One response is requested of each respondent. Completion is voluntary. However, failure to provide the requested information may result in a denial of the waiver request. The RRB proposes no changes to Form DR-423.
Under section 12 of the Railroad Retirement Act (RRA) (45 U.S.C. 231k), the RRB may pay annuity benefits to a representative payee when an employee, spouse, or survivor annuitant is incompetent or a minor. The RRB is responsible for determining if direct payment to an annuitant or a representative payee would best serve the annuitant's best interest. The accountability requirements authorizing the RRB to conduct periodic monitoring of representative payees, including a written accounting of benefit payments received, are prescribed in 20 CFR 266.7. The RRB utilizes the following forms to conduct its representative payee monitoring program.
Form G-99a,
Form G-106,
The RRB proposes the following changes for Form G-106:
• Add a drop-down box `Second Request' at the top of the form to when the RRB needs to follow-up with a Third-Party Custodian who did not respond to the initial request.
Under section 2 of the Railroad Retirement Act (45 U.S.C. 231a), an annuity is not payable, or is reduced for any month(s) in which the beneficiary works for a railroad or earns more than prescribed amounts. The provisions relating to the reduction or non-payment of annuities by reason of work are prescribed in 20 CFR 230.
The RRB utilizes Form G-19-F,
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to expand the Exchange's Cabinet Proximity Option program.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Currently, the Exchange offers a Cabinet Proximity Option program
Currently, the Exchange offers reservations for low, medium, medium/high, or high density cabinets under the Cabinet Proximity Option program.
The Exchange offers the Cabinet Proximity Option program as a convenience to customers. No firms are required to reserve cabinets via the Cabinet Proximity Option program and it is only for those customers that choose to collocate directly with the Exchange. Participants can avoid reserving cabinets under this program (and the related fee) by (1) collocating but not reserving space in advance of needing it; (2) ordering cabinet space immediately and paying cabinet fees (without reserving in advance); (3) collocating indirectly through a vendor to defray costs; or (4) not collocating at all.
The Exchange intends to submit a fee filing in the future to establish related fees in the existing Cabinet Proximity Option Fees, in General 8, Section 1(d). Implementation of the proposal described herein to offer the Exchange's Cabinet Proximity Option program for cabinets with power densities greater than 10 kW would coincide with the subsequent fee filing.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Nothing in the proposal imposes any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which exchanges and other vendors offer colocation services as a means to facilitate the trading and other market activities of those market participants who believe that colocation enhances the efficiency of their operations. The Cabinet Proximity Option program is comparable to PNU cabinets offered by NYSE, as discussed above.
Nothing in the Proposal burdens intra-market competition because the Cabinet Proximity Option program is available to any customer and customers that wish to make reservations pursuant to the Cabinet Proximity Option program can do so on a non-discriminatory basis. Use of any colocation service is completely voluntary, and each market participant is able to determine whether to use colocation services based on the requirements of its business operations.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 11, 2024, the Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“Commission”), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
This proposed rule change would re-issue interpretative guidance relating to the adjustment of stock options for cash dividends and distributions on underlying securities with certain amendments, including (1) to reflect previously approved changes in the process for making such adjustment determinations; and (2) to address OCC's general approach to certain additional scenarios. Amendments to the interpretative guidance, are included in Exhibit 5 of File No. SR-OCC-2024-003. Material proposed to be added is marked by underlining, and material proposed to be deleted is marked with strikethrough text. All terms with initial capitalization that are not otherwise defined herein have the same meaning as set forth in the By-Laws and Rules.
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
OCC is the issuer of and sole clearing agency for standardized equity options listed on national securities exchanges registered with the Commission. In accordance with OCC's By-Laws, adjustments may be made to some of the standardized terms of outstanding options upon the occurrence of certain events related to the underlying security, such as a stock dividend, stock distribution, stock split, reverse stock split, rights offering, distribution, reorganization, recapitalization, reclassification in respect of an underlying security, or a merger, consolidation, dissolution or liquidation of the issuer of the underlying security.
OCC previously filed with the Commission and issued interpretative guidance concerning the application of OCC's adjustment policies and procedures and other adjustment rules
OCC's By-Laws and Rules authorize OCC to make adjustments to listed options when certain events occur related to the underlying security, such as a stock dividend, stock distribution, stock split, reverse stock split, rights offering, distribution, reorganization, recapitalization, or reclassification with respect to the underlying security or the merger, consolidation, dissolution or liquidation of the issuer of the underlying security. The By-Laws provide policies and procedures for making such determinations, including that OCC determines whether to adjust a contract, taking into account such factors as fairness to holders and writers (or purchasers and sellers) of the affected contracts, the maintenance of a fair and orderly market in the affected contracts, consistency of interpretation and practice, efficiency of exercise settlement procedures, and the coordination with other clearing agencies of the clearance and settlement of transactions in the underlying interest.
OCC's By-Laws also provide general rules applicable to specific types of corporate actions, including with respect to cash dividends or distributions made by the issuer of an underlying security. For example, the By-Laws establish a general rule that OCC does not adjust listed options to reflect “ordinary cash dividends or distributions,” which the By-Laws define to mean “[c]ash dividends or distributions (regardless of size) by the issuer of the underlying security which [OCC] believes to have been declared pursuant to a policy or practice of paying such dividends or distributions on a quarterly or other regular basis or which [OCC] believes represents an acceleration or deferral of such payments.”
In connection with the adoption of the general rules against adjustments for cash dividends and distributions that are ordinary or below the de minimis threshold, OCC previously filed and published interpretative guidance promulgated by its Securities Committee to address questions about how those rules would be administered and applied.
The proposed changes would remove references to the adjustment panel of the Securities Committee in the interpretative guidance's discussion of how options adjustments are made. Since the interpretative guidance was last issued in 2012, the Commission approved a proposed rule change that affected the determination process.
OCC also proposes to add additional Q&As that would provide guidance for several situations OCC has observed since the interpretative guidance was last issued, including (a) specific guidance with respect to variable dividends, and (b) additional guidance with respect to dividends issued by real estate investment trusts (“REITs”).
OCC has seen an increase in the number of issuers that have established policies or practices of distributing “variable dividends.” Typically, such variable dividends are paid at regular intervals if issuer-defined thresholds for paying the dividends are met. The amount of the variable dividend may increase or decrease (sometimes significantly) from dividend to dividend based on issuer-established thresholds and, on occasion, may not be paid at all if the issuer-established thresholds are not met. These variable dividends may also be in addition to regular dividends paid pursuant to the issuer's policy or practice.
For example, on May 19, 2022, Arch Resources, Inc. (ARCH) announced an $8.11 quarterly dividend, which included a fixed component of $0.25 and a variable component of $7.86 per share. In making its adjustment determination, OCC considered an ARCH press release, issued on February 15, 2022, communicating that ARCH was launching a capital return program pursuant to which it planned to “return to stockholders approximately 50 percent of the prior quarter's discretionary cash flow . . . via a variable quarterly cash dividend in conjunction with its existing fixed quarterly cash dividend.”
As another example, on March 9, 2022, Zim Integrated Shipping Services Ltd. (ZIM) announced a cash dividend of $17.00 per share, representing 50% of ZIM's 2021 net income, taking into account the quarterly dividends paid during the first three fiscal quarters of the year.
OCC proposes to add a Q&A to the interpretative guidance reflecting that if OCC determines such variable dividends are paid pursuant to an issuer's policy or practice of paying such variable dividends at regular intervals, OCC generally considers them to be ordinary dividends and not adjustable, even if, on occasion, no variable dividend is paid or if the amount of the dividend increases or decreases based on the issuer-established thresholds. OCC believes this guidance would align with the precedent described above and provide market participants with greater clarity about how OCC applies the adjustment policies outlined in the By-Laws to variable dividends.
OCC proposes to add further guidance about situations in which an issuer may pay a dividend outside of its normal schedule of dividend payments that the issuer describes as necessary to maintain its tax status as a particular type of organization, such as a REIT. The existing interpretative guidance answered several questions concerning dividends paid by REITs and similar companies. For example, the existing interpretative guidance addressed that while REITs may pay dividends at irregular intervals, these companies often have regular dividend policies, but will actually pay dividends only when certain conditions are met, or in response to market conditions. Similar to the variable dividend situation, in which, on occasion, no variable dividend is paid if issuer-established thresholds are not met, the prior interpretative guidance provided that such REIT distributions generally would be considered ordinary distributions when they occur pursuant to the policy of the company.
However, OCC has observed at least one case in which an issuer has declared a dividend outside of its normal schedule of dividend payments to maintain its tax status as a particular type of organization, such as a REIT. Specifically, On July 22, 2022, Public Storage (“PSA”) announced a “special,” “one-time” dividend of $13.15 per common share.
As OCC would clarify in the further guidance, such a dividend would most likely be considered non-ordinary and warrant an adjustment if OCC determines that the dividend is not being made pursuant to the issuer's established dividend policies and practices based on the company's departure from its regular dividend schedule and any characterization the company may make about the pay-out as “special” or “one time.” In other words, an issuer's characterization of a dividend as necessary to maintain its tax status as a particular type of organization is not determinative of whether a dividend is “ordinary” under OCC's By-Laws. Rather, the question is whether the dividend is paid pursuant to an issuer's policy of paying such a dividend at regular intervals to maintain its tax status. If such an issuer announces a special dividend outside of its regular dividend policies and practices, such dividend will most likely be considered non-ordinary and warrant an adjustment even if the issuer is paying the dividend to maintain its tax status. OCC proposes to add a Q&A to the interpretative guidance to reflect OCC's practices in this situation.
OCC believes the proposed rule changes are consistent with Section 17A of the Exchange Act and the rules and regulations thereunder. Section 17A(b)(3)(F) of the Exchange Act
In addition, Exchange Act Rule 17Ad-22(e)(23) requires OCC to maintain written policies and procedures reasonably designed to, among other things, publicly disclose all relevant rules and material procedures and provide sufficient information to enable participants to identify and evaluate the risks they incur by participating in OCC.
Section 17A(b)(3)(I) of the Exchange Act requires that the rules of a clearing agency not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act.
Written comments were not and are not intended to be solicited with respect to the proposed rule change, and none have been received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection.
All submissions should refer to file number SR-OCC-2024-003 and should be submitted on or before March 27, 2024.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to expand the Exchange's Cabinet Proximity Option program.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Currently, the Exchange offers a Cabinet Proximity Option program where, for a monthly fee, customers can obtain an option for future use on available, unused cabinet space in proximity to their existing equipment. Cabinets reserved under the Cabinet Proximity Option program are unused cabinets that customers reserve for future use and can be converted to a powered cabinet at the customer's request. Under the program, customers can reserve up to maximum of 20 cabinets that the Exchange endeavors to provide as close as reasonably possible to the customer's existing cabinet space, taking into consideration power availability within segments of the datacenter and the overall efficiency of use of datacenter resources as determined by the Exchange. Should reserved datacenter space be needed for use, the reserving customer will have three business days to formally contract with the Exchange for full payment for the reserved cabinet space in contention or it will be reassigned. In making determinations to require exercise or relinquishment of reserved space as among numerous customers, the Exchange will take into consideration several factors, including: proximity between available reserved cabinet space and the existing space of a customer seeking additional space for actual cabinet usage; a customer's ratio of cabinets in use to those reserved; the length of time that a particular reservation(s) has been in place; and any other factor that the Exchange deems relevant to ensure overall efficiency in use of the datacenter space.
Currently, the Exchange offers reservations for low, medium, medium/high, or high density cabinets under the Cabinet Proximity Option program.
The Exchange offers the Cabinet Proximity Option program as a convenience to customers. No firms are required to reserve cabinets via the Cabinet Proximity Option program and it is only for those customers that choose to collocate directly with the Exchange. Participants can avoid reserving cabinets under this program (and the related fee) by (1) collocating but not reserving space in advance of needing it; (2) ordering cabinet space immediately and paying cabinet fees (without reserving in advance); (3) collocating indirectly through a vendor to defray costs; or (4) not collocating at all.
The Exchange intends to submit a fee filing in the future to establish related fees in the existing Cabinet Proximity Option Fees, in General 8, Section 1(d). Implementation of the proposal described herein to offer the Exchange's Cabinet Proximity Option program for cabinets with power densities greater than 10 kW would coincide with the subsequent fee filing.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Nothing in the proposal imposes any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which exchanges and other vendors offer colocation services as a means to facilitate the trading and other market activities of those market participants who believe that colocation enhances the efficiency of their operations. The Cabinet Proximity Option program is comparable to PNU cabinets offered by NYSE, as discussed above.
Nothing in the Proposal burdens intra-market competition because the Cabinet Proximity Option program is available to any customer and customers that wish to make reservations pursuant to the Cabinet Proximity Option program can do so on a non-discriminatory basis. Use of any colocation service is completely voluntary, and each market participant is able to determine whether to use colocation services based on the requirements of its business operations.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange is filing a proposal to amend the Fee Schedule to: (i) apply the Exchange's current Connectivity and Application Session fees to MEMX Options Users, and (ii) make an organizational change to its existing fee schedule for the Exchange's pre-existing equities market (“MEMX Equities”), in order to create a separate fee schedule for Connectivity Fees (for both MEMX Equities and MEMX Options). The Exchange proposes to implement the changes to the Fee Schedule pursuant to this proposal immediately. The text of the proposed rule change is provided in Exhibit 5.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is filing a proposal to amend the Fee Schedule to: (i) apply the Exchange's current Connectivity and Application Session fees to MEMX Options Users, and (ii) make an organizational change to its existing fee schedule for the Exchange's pre-existing equities market (“MEMX Equities”), in order to create a separate fee schedule for Connectivity Fees (for both MEMX Equities and MEMX Options). The Exchange believes that these changes will provide greater transparency to Members about how the Exchange assesses fees, as well as allowing Members to more easily validate their bills on a monthly basis. The Exchange notes that none of these changes amend any existing fee applicable to MEMX Equities. The Exchange is proposing to implement the proposal immediately. The Exchange previously filed the proposal on October 24, 2023 (SR-MEMX-2023-29) (the “Initial Proposal”). The Exchange withdrew the Initial Proposal and replaced the proposal with SR-MEMX-2023-39 (the “Second Proposal”). The Exchange recently withdrew the Second Proposal and is replacing it with the current filing (SR-MEMX-2024-06).
As set forth below, the Exchange believes that its proposal provides a great deal of transparency regarding the cost of providing connectivity services and anticipated revenue and that the proposal is consistent with the Act and associated guidance. The Exchange is re-filing this proposal promptly following the withdrawal of the Second Proposal in order to update the Cost Analysis included in the Second Proposal.
As noted above, the Exchange is proposing to apply the current fees it charges to Members and non-Members
In general, the Exchange believes that exchanges, in setting fees of all types, should meet very high standards of transparency to demonstrate why each new fee or fee increase meets the Exchange Act requirements that fees be reasonable, equitably allocated, not unfairly discriminatory, and not create an undue burden on competition among members and markets. In particular, the Exchange believes that each exchange should take extra care to be able to demonstrate that these fees are based on its costs and reasonable business needs.
In proposing to charge fees for connectivity services to MEMX Options, the Exchange has sought to be especially diligent in assessing those fees in a transparent way against its own aggregate costs of providing the related services, and also carefully and transparently assessing the impact on Members—both generally and in relation to other Members,
As detailed below, MEMX calculated its aggregate annual costs for providing physical connectivity to both MEMX Equities and MEMX Options in 2024 at $14,970,454 and its aggregate annual costs for providing application sessions at $7,185,273. In order to cover the aggregate costs of providing connectivity to its Options and Equities Users (both Members and non-Members) going forward and to make a modest profit, as described below, the Exchange is proposing to modify its Fee Schedule, pursuant to MEMX Rules 15.1(a) and (c), to charge a fee to Options Users, as it currently does to Equities Users, of $6,000 per month for each physical connection in the Primary Data Center and of $3,000 per month for each physical connection in the Secondary Data Center. The Exchange also proposes to modify its Fee Schedule, pursuant to MEMX Rules 15.1(a) and (c), to charge a fee to Options Users, as it currently does to Equities Users, of $450 per month for each Order Entry Port and Drop Copy Port in the Exchange's Primary Data Center, as further described below.
In February 2024, MEMX completed an updated study of its aggregate projected costs to produce market data and connectivity across both its Equities and Options platforms in 2024 (the “Cost Analysis”).
By allocating segmented costs to each core service, MEMX was able to estimate by core service the potential margin it might earn based on different fee models. The Exchange notes that as a non-listing venue it has four primary sources of revenue that it can potentially use to fund its operations: transaction fees, fees for connectivity services, membership and regulatory fees, and market data fees. Accordingly, the Exchange must cover its expenses from these four primary sources of revenue. The Exchange also notes that as a general matter each of these sources of revenue is based on services that are interdependent. For instance, the Exchange's system for executing transactions is dependent on physical hardware and connectivity; only Members and parties that they sponsor to participate directly on the Exchange may submit orders to the Exchange; many Members (but not all) consume market data from the Exchange in order to trade on the Exchange; and the Exchange consumes market data from external sources in order to comply with regulatory obligations. Accordingly, given this interdependence, the allocation of costs to each service or revenue source required judgment of the Exchange and was weighted based on estimates of the Exchange that the Exchange believes are reasonable, as set forth below.
Through the Exchange's extensive Cost Analysis, the Exchange analyzed every expense item in the Exchange's general expense ledger to determine whether each such expense relates to the provision of connectivity services, and, if such expense did so relate, what portion (or percentage) of such expense actually supports the provision of connectivity services, and thus bears a relationship that is, “in nature and closeness,” directly related to network connectivity services. In turn, the Exchange allocated certain costs more to physical connectivity and others to application sessions, while certain costs were only allocated to such services at a very low percentage or not at all, using consistent allocation methodologies as described above. Based on this analysis, MEMX estimates that the cost drivers to provide connectivity services in 2024, including both physical connections and application sessions, will result in an aggregate annual cost of $22,155,727, as further detailed below. The Exchange notes that it utilized the same principles to generate the 2021 Cost Analysis, applicable to Equities only, and at that time, the estimated annual aggregate cost to provide connectivity services was $13,724,580. The differences between such estimated costs and the overall analysis are primarily based on: (1) the addition of MEMX Options, (ii) increased, and in some cases decreased, costs projected by the Exchange, (iii) and changes made to reallocate certain costs into categories that more closely align the Exchange's audited financial statements, as further described below.
The following chart details the individual line-item costs considered by MEMX to be related to offering physical connectivity as well as the percentage of the Exchange's overall costs such costs represent for such area (
Below are additional details regarding each of the line-item costs considered by MEMX to be related to offering physical connectivity, as well as any relevant discussion of how the costs projected for 2024 differ, if any, from the Exchange's previous Cost Analysis conducted in 2021 in adopting Connectivity Fees for its Equities platform, which are the same fees the
In allocating personnel (Human Resources) costs, in order to not double count any allocations, the Exchange first excluded any employee time allocated towards options regulation in order to recoup costs via the Options Regulatory Fee (“ORF”).
In 2021, 13.8% of the Exchange's Human Resources costs were allocated towards the provision of physical connectivity, which is slightly lower than the 18% allocation in the current Cost Analysis. The Exchanges notes that this increase is due to additional hiring necessary to support network infrastructure, and that in advance of the launch of MEMX Options, this hiring started at the beginning of 2023.
The Connectivity cost includes external fees paid to connect to other exchanges and third parties. The Exchange notes that its connectivity to external markets is required in order to receive market data to run the Exchange's matching engine and basic operations compliant with existing regulations, primarily Regulation NMS. Approximately 75% of the Exchange's connectivity costs are allocated towards the provision of physical connectivity, which is the same percentage identified in the 2021 Cost Analysis. Of note, the 2021 Cost Analysis allocated approximately $162,000 per month of connectivity costs towards physical connectivity, which is notably higher than the $61,018
Data Center costs include an allocation of the costs the Exchange incurs to provide physical connectivity in the third-party data centers where it maintains its equipment (such as dedicated space, security services, cooling and power). The Exchange notes that it does not own the Primary Data Center or the Secondary Data Center, but instead, leases space in data centers operated by third parties. The Exchange has allocated a high percentage of the Data Center cost (80%) to physical connectivity because the third-party data centers and the Exchange's physical equipment contained therein is the most direct cost in providing physical access to the Exchange. In other words, for the Exchange to operate in a dedicated space with connectivity of participants to a physical trading platform, the data centers are a very tangible cost, and in turn, if the Exchange did not maintain such a presence then physical connectivity would be of no value to market participants. This slight increase over the allocation of Data Center costs to physical connectivity from 2021 (75%) is due to the Exchange's determination that the Data Center is more directly linked to physical connectivity than any other core service provided by the Exchange.
The Technology category includes the Exchange's network infrastructure, other hardware, software, and software licenses used to operate and monitor physical assets necessary to offer physical connectivity to the Exchange. Of note, certain of these costs were included in the Connectivity and a separate Hardware and Software Licenses category in the 2021 Cost Analysis; however, in order to align more closely with the Exchange's audited financial statements these costs were combined into the broader Technology category. The Exchange allocated approximately 25% of its Technology costs to physical connectivity in 2024.
All physical assets and software, which also includes assets used for testing and monitoring of Exchange infrastructure, were valued at cost, depreciated or leased over periods ranging from three to five years. Thus, the depreciation cost primarily relates to servers necessary to operate the Exchange, some of which are owned by the Exchange and some of which are leased by the Exchange in order to allow efficient periodic technology refreshes. As noted above, the Exchange allocated 39% of all depreciation costs to providing physical connectivity. This is a higher percentage than was allocated to providing physical connectivity in 2021 (18.5%), and this increase is due to a high amount of capital expenditures required to build the Exchange's options platform, none of which began to depreciate until the launch of options in September 2023. The Exchange notes, however, that it did not allocate depreciation costs for any internally developed software to build the Exchange's trading platforms to physical connectivity, as such software does not impact the provision of physical connectivity.
External Market Data includes fees paid to third parties, including other exchanges, to receive and consume market data from other markets. The Exchange notes that it did not allocate any External Market Data fees to the provision of physical connectivity as market data is not related to such services.
Finally, a limited portion of general shared expenses was allocated to physical connectivity as without these general shared costs the Exchange would not be able to operate in the manner that it does and provide physical connectivity. The costs included in general shared expenses include general expenses of the Exchange, including office space and office expenses (
As a final part of the Exchange's analysis related to physical connectivity, the Exchange determined the total
The following chart details the individual line-item costs considered by MEMX to be related to offering application sessions as well as the percentage of the Exchange's overall costs such costs represent for such area (
With respect to application sessions, MEMX calculated Human Resources cost by taking an allocation of employee time for employees whose functions include providing application sessions and maintaining performance thereof (including a broader range of employees such as technical operations personnel, market operations personnel, and software engineering personnel) as well as a limited subset of personnel with ancillary functions related to maintaining such connectivity (such as sales, membership, and finance personnel). The estimates of Human Resources cost were again determined by consulting with department leaders, determining which employees are involved in tasks related to providing application sessions and maintaining performance thereof, and confirming that the proposed allocations were reasonable based on an understanding of the percentage of their time such employees devote to tasks related to providing application sessions and maintaining performance thereof. The Exchange notes that senior level executives were only allocated Human Resources costs to the extent the Exchange believed they are involved in overseeing tasks related to providing application sessions and maintaining performance thereof. The Human Resources cost was again calculated
The Connectivity cost includes external fees paid to connect to other exchanges, as described above. The Exchange allocated approximately 4% of its Connectivity costs to providing application sessions.
Data Center costs include an allocation of the costs the Exchange incurs to provide physical connectivity in the third-party data centers where it maintains its equipment as well as related costs (the Exchange does not own the Primary Data Center or the Secondary Data Center, but instead, leases space in data centers operated by third parties). As shown in the table, the Exchange allocated 11% of its Data Center costs to application sessions in the current Cost Analysis, which represents an increase over the 2.6% it allocated in the 2021 Cost Analysis.
The Technology category includes the Exchange's network infrastructure, other hardware, software, and software licenses used to monitor the health of the order entry services provided by the Exchange. The Exchange allocated 12% of its Technology costs to the provision of application sessions, which represents a slight increase over the 10.1% it allocated in the 2021 Cost Analysis.
External Market Data includes fees paid to third parties, including other exchanges, to receive and consume market data from other markets. The Exchange allocated 20% of External Market Data fees to the provision of application sessions as such market data is necessary to offer certain services related to such sessions, such as validating orders on entry against the National Best Bid and National Best Offer (“NBBO”) and checking for other conditions (
All physical assets and software, which also includes assets used for testing and monitoring of order entry infrastructure, were valued at cost, depreciated or leased over periods ranging from three to five years. Thus, the depreciation cost primarily relates to servers necessary to operate the Exchange, some of which is owned by the Exchange and some of which is leased by the Exchange in order to allow efficient periodic technology refreshes. The Exchange allocated 14% of all depreciation costs to providing application sessions, which represents an increase over the 8.3% allocated in the 2021 Cost Analysis. In contrast to physical connectivity, described above, the Exchange did allocate depreciation costs for depreciated internally developed software to build the Exchange's platforms to application sessions because such software is related to the provision of such connectivity.
Finally, a limited portion of general shared expenses was allocated to overall application session costs as without these general shared costs the Exchange would not be able to operate in the manner that it does and provide application sessions. The costs included in general shared expenses include general expenses of the Exchange, including office space and office expenses (
Lastly, the Exchange determined the total
In conducting its Cost Analysis, the Exchange did not allocate any of its expenses in full to any core services (including physical connectivity or application sessions) and did not double-count any expenses. Instead, as described above, the Exchange allocated applicable cost drivers across its core services and used the same Cost Analysis to form the basis of this proposal and the filing it recently submitted proposing the establishment of an ORF.
In total, the Exchange allocated 18% of its Human Resources costs to providing physical connections and 11% of its Human Resources costs to providing application sessions, for a total allocation of 29% of its Human Resources expense to provide connectivity services. In turn, the Exchange allocated the remaining 71% of its Human Resources expense to Regulatory Services (21%), membership (2%) and transactions and market data (48%). Thus, again, the Exchange's allocations of cost across core services were based on real costs of operating the Exchange and were not double-counted across the core services or their associated revenue streams.
As another example, the Exchange allocated depreciation expense to all core services, including physical connections and application sessions, but in different amounts. The Exchange believes it is reasonable to allocate the identified portion of such expense because such expense includes the actual cost of the computer equipment, such as dedicated servers, computers, laptops, monitors, information security appliances and storage, and network switching infrastructure equipment, including switches and taps that were purchased to operate and support the network. Without this equipment, the Exchange would not be able to operate the network and provide connectivity services to its Members and non-Members and their customers. However, the Exchange did not allocate all of the depreciation and amortization expense toward the cost of providing connectivity services, but instead allocated approximately 53% of the Exchange's overall depreciation and amortization expense to connectivity services (39% attributed to physical connections and 14% to application sessions). The Exchange allocated the remaining depreciation and amortization expense (approximately 47%) toward regulatory services (approximately 6%), and to providing transaction services and market data (approximately 41%).
Looking at the Exchange's operations holistically, the estimated total monthly costs to the Exchange for offering core services in 2024 is $5,299,754, compared to the $3,954,537 noted in the 2021 Cost Analysis. Based on its projections, the Exchange expects to collect approximately $2,076,238 on a monthly basis for connectivity services. Incorporating this amount into the Exchange's overall projected revenue, including projections related to the ORF, the Exchange anticipates monthly revenue of approximately $6,080,631 from all sources (
The Exchange notes that its revenue estimates are based on projections across all potential revenue streams and will only be realized to the extent such revenue streams actually produce the revenue estimated. As a new entrant to the hyper-competitive exchange environment, and an exchange focused on driving competition, the Exchange does not yet know whether such expectations will be realized. For instance, in order to generate the revenue expected from connectivity, the Exchange will have to be successful in retaining existing options clients that wish to maintain physical connectivity and/or application sessions or in obtaining new clients that will purchase such services. Similarly, the Exchange will have to be successful in retaining a positive net capture on transaction fees in order to realize the anticipated revenue from transaction pricing.
The Exchange notes that the Cost Analysis was based on the Exchange's current operations and projections for the remainder of 2024. As such, the Exchange believes that its costs will remain relatively similar in future years (as demonstrated by the comparison of the 2021 Cost Analysis to the 2024 Cost Analysis). It is possible however that such costs will either decrease or increase. To the extent the Exchange sees growth in use of connectivity services it will receive additional revenue to offset future cost increases. However, if use of connectivity services is static or decreases, the Exchange might not realize the revenue that it anticipates or needs in order to cover applicable costs. Accordingly, the Exchange is committing to conduct a one-year review after implementation of these fees. The Exchange expects that it may propose to adjust fees at that time, to increase fees in the event that revenues fail to cover costs and a reasonable mark-up of such costs. Similarly, the Exchange would propose to decrease fees in the event that revenue materially exceeds our current projections. In addition, the Exchange will periodically conduct a review to inform its decision making on whether a fee change is appropriate (
MEMX offers its Members the ability to connect to the Exchange in order to transmit orders to and receive information from the Exchange. Members can also choose to connect to MEMX indirectly through physical connectivity maintained by a third-party extranet. Extranet physical connections may provide access to one or multiple Members on a single connection. Users of MEMX physical connectivity services (both Members and non-Members
As described above, the Exchange has previously justified its pricing with respect to MEMX Equities and believes the most fair approach, absent a significant differentiation between application costs to Equities and Options, is to apply the same pricing to all participants of either platform. As such, in order to cover the aggregate costs of providing physical connectivity to Options and Equities Users and make a modest profit, as described below, the Exchange is proposing to charge a fee of $6,000 per month for each physical connection in the Primary Data Center and a fee of $3,000 per month for each physical connection in the Secondary Data Center for connections to its Options platform, as it currently charges for connections to its Equities platform. There is no requirement that any Member maintain a specific number of physical connections and a Member may choose to maintain as many or as few of such connections as each Member deems appropriate. Further, as noted above, existing Equities Members may choose to use their existing physical connection(s) to access the Exchange's Options platform.
The Exchange notes, however, that pursuant to Rule 2.4 (Mandatory Participation in Testing of Backup Systems), the Exchange does require a small number of Members to connect and participate in functional and performance testing as announced by the Exchange, which occurs at least once every 12 months. Specifically, Members that have been determined by the Exchange to contribute a meaningful percentage of the Exchange's overall volume must participate in mandatory testing of the Exchange's backup systems (
The proposed fee will not apply differently based upon the size or type of the market participant, but rather based upon the number of physical connections a User requests, based upon factors deemed relevant by each User (either a Member, service bureau or extranet). The Exchange believes these factors include the costs to maintain connectivity, business model and choices Members make in how to participate on the Exchange, as further described below.
The proposed fee of $6,000 per month for physical connections at the Primary Data Center is designed to permit the Exchange to cover the costs allocated to providing connectivity services with a modest profit margin (approximately 11.7%), which would also help fund future expenditures (increased costs, improvements, etc.). The Exchange believes it is appropriate to charge fees that represent a reasonable markup over cost given the other factors discussed above and the need for the Exchange to maintain a highly performant and stable platform to allow Members to transact with determinism.
As noted above, the Exchange proposes a discounted rate of $3,000 per month for physical connections at its Secondary Data Center. The Exchange has proposed this discounted rate for Secondary Data Center connectivity in order to encourage Members to establish and maintain such connections. Also, as noted above, a small number of Members are required pursuant to Rule 2.4 to connect and participate in testing of the Exchange's backup systems, and the Exchange believes it is appropriate to provide a discounted rate for physical connections at the Secondary Data Center given this requirement. The Exchange notes that this rate is well below the cost of providing such services and the Exchange will operate its network and systems at the Secondary Data Center without recouping the full amount of such cost through connectivity services.
The proposed fee for physical connections is effective on filing and will become operative immediately, subject to the proposed waiver described below.
Similar to other exchanges, MEMX offers its Members application sessions, also known as logical ports, for order entry and receipt of trade execution reports and order messages. Members can also choose to connect to MEMX indirectly through a session maintained by a third-party service bureau. Service bureau sessions may provide access to one or multiple Members on a single session. Users of MEMX connectivity services (both Members and non-Members
As described above, in order to cover the aggregate costs of providing application sessions to Options Users and to make a modest profit, as described below, the Exchange is proposing to charge a fee of $450 per month for each Order Entry Port and Drop Copy Port in the Primary Data Center for Options application sessions, which is the same fee it currently charges for Equities application sessions. The Exchange notes that it does not propose to charge for: (1) Order Entry Ports or Drop Copy Ports in the Secondary Data Center, or (2) any Test Facility Ports or MEMOIR Gap Fill Ports, again, which it does not charge for Equities Users. The Exchange has proposed to continue to provide Order Entry Ports and Drop Copy Ports in the Secondary Data Center for Options free of charge in order to encourage Members to connect to the Exchange's backup trading systems. Similarly, because the Exchange wishes to encourage Members to conduct appropriate testing of their use of the Exchange, the Exchange has not proposed to charge for Test Facility Ports. With respect to MEMOIR Gap Fill ports, such ports are exclusively used in order to receive information when a market data recipient has temporarily lost its view of MEMX market data. The Exchange has not proposed charging for such ports because the costs of providing and maintaining such ports is more directly related to producing market data.
The proposed fee of $450 per month for each Order Entry Port and Drop Copy Port in the Primary Data Center is designed to permit the Exchange to cover the costs allocated to providing application sessions with a modest profit margin (approximately 9.7%), which would also help fund future expenditures (increased costs, improvements, etc.).
The proposed fee is also designed to encourage Users to be efficient with their application session usage, thereby resulting in a corresponding increase in the efficiency that the Exchange would be able to realize in managing its aggregate costs for providing connectivity services. There is no requirement that any Member maintain a specific number of application sessions and a Member may choose to maintain as many or as few of such ports as each Member deems appropriate. The Exchange has designed its platform such that Order Entry Ports can handle a significant amount of message traffic (
The proposed fee will not apply differently based upon the size or type of the market participant, but rather based upon the number of application sessions a User requests, based upon factors deemed relevant by each User (either a Member or service bureau on behalf of a Member). The Exchange believes these factors include the costs to maintain connectivity and choices Members make in how to segment or allocate their order flow.
The proposed fee for application sessions is effective on filing and will become operative immediately, subject to the proposed waiver described below.
As discussed above, the proposed fees for connectivity services do not by design apply differently to different types or sizes of Members. As discussed in more detail in the Statutory Basis section, the Exchange believes that the likelihood of higher fees for certain Members subscribing to connectivity services usage than others is not unfairly discriminatory because it is based on objective differences in usage of connectivity services among different Members. The Exchange's incremental aggregate costs for all connectivity services are disproportionately related to Members with higher message traffic and/or Members with more complicated connections established with the Exchange, as such Members: (1) consume the most bandwidth and resources of the network; (2) transact the vast majority of the volume on the Exchange; and (3) require the high-touch network support services provided by the Exchange and its staff, including network monitoring, reporting and support services, resulting in a much higher cost to the Exchange to provide such connectivity services. For these reasons, MEMX believes it is not unfairly discriminatory for the Members with higher message traffic and/or Members with more complicated connections to pay a higher share of the total connectivity services fees. While Members with a business model that results in higher relative inbound message activity or more complicated connections are projected to pay higher fees, the level of such fees is based solely on the number of physical connections and/or application sessions deemed necessary by the Member and not on the Member's business model or type of Member. The Exchange notes that the correlation between message traffic and usage of connectivity services is not completely aligned because Members individually determine how many physical connections and application sessions to request, and Members may make different decisions on the appropriate ways based on facts unique to their individual businesses. Based on the Exchange's architecture, as described above, the Exchange believes that a Member even with high message traffic would be able to conduct business on the Exchange with a
Finally, the fees for connectivity services will help to encourage connectivity services usage in a way that aligns with the Exchange's regulatory obligations. As a national securities exchange, the Exchange is subject to Regulation Systems Compliance and Integrity (“Reg SCI”).
The Exchange is proposing to more clearly separate Connectivity Fees from the Exchange's current fee schedule. Currently, the Exchange has separate transaction fee schedules for Equities and Options, and the current Connectivity Fees appear solely on the Equities fee schedule. The Exchange proposes to remove the Connectivity Fees section from the Equities fee schedule, and add hyperlinks at the bottom of the Equities and Options fee schedules that direct the User to a single Connectivity fee schedule. The Exchange believes this format is appropriate given that the same Connectivity Fees apply to both Equities and Options Users, and separating out the fee schedule for Connectivity Fees will reduce potential confusion (
The Exchange also proposes to add three additional bullet points to the new Connectivity Fee Schedule related to MEMX Options. The first will notify Members that a physical connection can be used to access MEMX Equities and/or MEMX Options. The second will clarify that an application session can only be used to access one MEMX platform,
The Exchange believes that the proposed fees for connectivity services to MEMX Options are reasonable, equitable and not unfairly discriminatory because, as described above, the proposed pricing for connectivity services is directly related to the relative costs to the Exchange to provide those respective services and does not impose a barrier to entry to smaller participants.
The Exchange recognizes that there are various business models and varying sizes of market participants conducting business on the Exchange. The Exchange's incremental aggregate costs for all connectivity services are disproportionately related to Members with higher message traffic and/or Members with more complicated connections established with the Exchange, as such Members: (1) consume the most bandwidth and resources of the network; (2) transact the vast majority of the volume on the Exchange; and (3) require the high-touch network support services provided by the Exchange and its staff, including network monitoring, reporting and support services, resulting in a much higher cost to the Exchange to provide such connectivity services. Accordingly, the Exchange believes the allocation of the proposed fees that increase based on the number of physical connections or application sessions is reasonable based on the resources consumed by the respective type of market participant (
With regard to reasonableness, the Exchange understands that when appropriate given the context of a proposal the Commission has taken a market-based approach to examine whether the SRO making the proposal was subject to significant competitive forces in setting the terms of the proposal. In looking at this question, the Commission considers whether the SRO has demonstrated in its filing that: (i) there are reasonable substitutes for the product or service; (ii) “platform” competition constrains the ability to set the fee; and/or (iii) revenue and cost analysis shows the fee would not result in the SRO taking supra-competitive profits. If the SRO demonstrates that the fee is subject to significant competitive forces, the Commission will next consider whether there is any substantial countervailing basis to suggest the fee's terms fail to meet one or more standards under the Exchange Act. If the filing fails to demonstrate that the fee is constrained by competitive forces, the SRO must provide a substantial basis, other than competition, to show that it is consistent with the Exchange Act, which may include production of relevant revenue and cost data pertaining to the product or service.
MEMX believes the proposed fees for connectivity services are fair and reasonable as a form of cost recovery for the Exchange's aggregate costs of offering connectivity services to Members and non-Members. The proposed fees are expected to generate monthly revenue of $2,076,238 providing cost recovery to the Exchange for the aggregate costs of offering
The Exchange further believes that the proposed fees, as they pertain to purchasers of each type of connectivity alternative, constitute an equitable allocation of reasonable fees charged to the Exchange's Members and non-Members and are allocated fairly amongst the types of market participants using the facilities of the Exchange.
As described above, the Exchange believes the proposed fees are equitably allocated because the Exchange's incremental aggregate costs for all connectivity services are disproportionately related to Members with higher message traffic and/or Members with more complicated connections established with the Exchange, as such Members: (1) consume the most bandwidth and resources of the network; (2) transact the vast majority of the volume on the Exchange; and (3) require the high-touch network support services provided by the Exchange and its staff, including network monitoring, reporting and support services, resulting in a much higher cost to the Exchange to provide such connectivity services.
Commission staff previously noted that the generation of supra-competitive profits is one of several potential factors in considering whether an exchange's proposed fees are consistent with the Act.
The proposed fees for Options connectivity services will allow the Exchange to cover certain costs incurred by the Exchange associated with providing and maintaining necessary hardware and other network infrastructure as well as network monitoring and support services; without such hardware, infrastructure, monitoring and support the Exchange would be unable to provide the connectivity services. The Exchange routinely works to improve the performance of the network's hardware and software. The costs associated with maintaining and enhancing a state-of-the-art exchange network is a significant expense for the Exchange, and thus the Exchange believes that it is reasonable and appropriate to help offset those costs by adopting fees for connectivity services. As detailed above, the Exchange has four primary sources of revenue that it can potentially use to fund its operations: transaction fees, fees for connectivity services, membership and regulatory fees, and market data fees. Accordingly, the Exchange must cover its expenses from these four primary sources of revenue. The Exchange's Cost Analysis estimates the monthly costs to provide connectivity services at $1,846,310.58. Based on current connectivity services usage, the Exchange would generate monthly revenues of approximately $2,076,238. This represents a modest profit when compared to the cost of providing connectivity services and that profit represents a modest increase over the profit estimated in the 2021 Cost Analysis (a reasonable goal for a newly formed business,
As noted above, when incorporating the projected revenue from connectivity services into the Exchange's overall projected revenue, including projections related to recently adopted market data fees, the Exchange anticipates monthly revenue of $6,080,631 from all sources. As such, applying the Exchange's holistic Cost Analysis to a holistic view of anticipated revenues, the Exchange would earn approximately 13% margin on its operations as a whole. The Exchange believes that this amount is reasonable and is again evidence that the Exchange will not earn a supra-competitive profit.
The Exchange notes that other exchanges offer similar connectivity options to market participants and that the Exchange's fees are a discount as compared to the majority of such fees.
In conclusion, the Exchange submits that its proposed fee structure satisfies the requirements of Sections 6(b)(4) and 6(b)(5) of the Act
The Exchange believes that the proposed reorganization of its fee schedule to establish a separate fee schedule for Connectivity Fees is reasonable and equitable because it is a non-substantive change and does not involve changing any existing fees or rebates that apply to trading activity on MEMX Equities. Further, the changes are designed to make the fee schedule easier to read and for Members to validate the bills they receive from the Exchange. The Exchange also believes this reorganization is non-discriminatory because it applies uniformly to all Members. The Exchange believes the proposed fee schedule will be clearer and less confusing for Members of the Exchange and will eliminate potential Member confusion, thereby removing impediments to and perfecting the mechanism of a free and open market and a national market, and in general, protecting investors and the public interest.
In accordance with Section 6(b)(8) of the Act,
The Exchange does not believe that the proposed rule change to apply the same Connectivity Fees to Options Users as it does to Equities Users would place certain market participants at the Exchange at a relative disadvantage compared to other market participants because the proposed connectivity pricing is associated with relative usage of the Exchange by each market participant and does not impose a barrier to entry to smaller participants. As noted above, the Exchange has previously justified its pricing with respect to MEMX Equities and believes the most fair approach, absent a significant differentiation between application costs to Equities and Options, is to apply the same pricing to all participants of either platform. The Exchange believes its proposed pricing is reasonable and lower than what other options exchanges charge and, when coupled with the availability of third-party providers that also offer connectivity solutions, that participation on the Exchange is
As it relates to the reorganization of the fee schedule, as discussed above, the Exchange does not believe that the proposed change would impose any burden on competition because such change serves to create an easier to read fee schedule to avoid any Member confusion.
The Exchange does not believe the proposed fees for Options Connectivity place an undue burden on competition on other SROs that is not necessary or appropriate. Additionally, other exchanges have similar connectivity alternatives for their participants, but with higher rates to connect.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17Ad-6 requires every registered transfer agent to make and keep current
Rule 17Ad-7 requires each registered transfer agent to retain the records specified in Rule 17Ad-6 in an easily accessible place for a period of six months to six years, depending on the type of record or document. Rule 17Ad-7 also specifies the manner in which records may be maintained using electronic, microfilm, and microfiche storage methods.
These recordkeeping requirements are designed to ensure that all registered transfer agents are maintaining the records necessary for them to monitor and keep control over their own performance and for the Commission to adequately examine registered transfer agents on an historical basis for compliance with applicable rules.
The Commission estimates that approximately 315 registered transfer agents will spend a total of 157,500 hours per year complying with Rules 17Ad-6 and 17Ad-7 (500 hours per year per transfer agent).
The retention period under Rule 17Ad-7 for the recordkeeping requirements under Rule 17Ad-6 is six months to six years, depending on the particular record or document. The recordkeeping and retention requirements under Rules 17Ad-6 and 17Ad-7 are mandatory to assist the Commission and other regulatory agencies with monitoring transfer agents and ensuring compliance with the rules. These rules do not involve the collection of confidential information.
Written comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information 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. Consideration will be given to comments and suggestions submitted by May 6, 2024.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: David Bottom, Director/Chief Information Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 7.19E to make additional pre-trade risk controls available to Entering Firms and Clearing Firms. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 7.19E to make additional pre-trade risk controls available to Entering Firms and Clearing Firms.
In 2020, in order to assist ETP Holders' efforts to manage their risk, the Exchange amended its rules to add Rule 7.19E (Pre-Trade Risk Controls),
The Exchange has recently received several requests from market participants to create two additional
The Exchange notes that the MIAX Pearl equities exchange (“MIAX Pearl”) currently offers risk controls substantially similar to those proposed here. Specifically, MIAX Pearl offers its “Equity Members” and their “Clearing Members” the option to use a “Gross Notional Trade Value” risk check, which includes only executed orders, and a “Gross Notional Open Value” risk check, which includes only unexecuted orders, in addition to a “Gross Notional Open and Trade Value” risk check, for which both executed and unexecuted orders are included.
In light of these requests, the Exchange proposes to amend Rule 7.19E(b)(1) to rename the existing Gross Credit Risk Limit as “Gross Credit Risk Limit—Open + Executed,” and to add two additional risk limits: “Gross Credit Risk Limit—Open Only” and “Gross Credit Risk Limit—Executed Only.”
Specifically, the Exchange proposes to amend and reorganize Rule 7.19E(b)(1) as follows. First, the Exchange would amend the language in the first sentence of the rule to refer to plural Gross Credit Risk Limits, instead of just one. At the end of the first sentence, the Exchange would add that “[a]vailable Gross Credit Risk Limits include” the three types described in new sub-sections (A), (B), and (C).
Proposed sub-section (A) would define the “Gross Credit Risk Limit—Open + Executed” risk check to include unexecuted orders in the Exchange Book, orders routed on arrival pursuant to Rule 7.37E(a)(1), and executed orders (just as the current Gross Credit Risk Limit does).
Proposed sub-section (B) would define the “Gross Credit Risk Limit—Open Only” risk check to include only unexecuted orders in the Exchange Book and orders routed on arrival pursuant to Rule 7.37E(a)(1).
Proposed sub-section (C) would define the “Gross Credit Risk Limit—Executed Only” risk check to include executed orders only.
In addition, the Exchange proposes to make a conforming change to section (c)(1)(B) of the rule, to make plural the current singular reference to “Gross Credit Risk Limit.”
As with the Exchange's existing risk controls, use of the pre-trade risk controls proposed herein would be optional. The Exchange proposes no other changes to Rule 7.19E or its Commentary.
The proposed Pre-Trade Risk Controls described here are meant to supplement, and not replace, the ETP Holders' own internal systems, monitoring, and procedures related to risk management. The Exchange does not guarantee that these controls will be sufficiently comprehensive to meet all of an ETP Holder's needs, the controls are not designed to be the sole means of risk management, and using these controls will not necessarily meet an ETP Holder's obligations required by Exchange or federal rules (including, without limitation, the Rule 15c3-5 under the Act
The Exchange anticipates implementing the proposed change in the first quarter of 2024 and, in any event, will implement the proposed rule change no later than the end of June 2024. The Exchange will announce the timing of such changes by Trader Update.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
Specifically, the Exchange believes that the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system because the proposed additional Pre-Trade Risk Controls would provide Entering Firms and Clearing Firms with enhanced abilities to manage their risk with respect to orders on the Exchange. The proposed additional Pre-Trade Risk Controls are not novel; they are based on existing risk settings already in place on MIAX Pearl and market participants are already familiar with the types of protections that the proposed risk controls afford.
In addition, the Exchange believes that the proposed rule change will protect investors and the public interest because the proposed additional Pre-Trade Risk Controls are a form of impact mitigation that will aid Entering Firms and Clearing Firms in minimizing their risk exposure and reduce the potential for disruptive, market-wide events. The Exchange understands that ETP Holders implement a number of different risk-based controls, including those required by Rule 15c3-5. The controls proposed here will serve as an additional tool for Entering Firms and Clearing Firms to assist them in identifying any risk exposure. The Exchange believes the proposed additional Pre-Trade Risk Controls will assist Entering Firms and Clearing Firms in managing their financial exposure which, in turn, could enhance the integrity of trading on the securities markets and help to assure the stability of the financial system.
Finally, the Exchange believes that the proposed rule change does not unfairly discriminate among the Exchange's ETP Holders because use of the proposed additional Pre-Trade Risk Controls is optional and is not a prerequisite for participation on the Exchange.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. In fact, the Exchange believes that the proposal will have a positive effect on competition because, by providing Entering Firms and Clearing Firms additional means to monitor and control risk, the proposed rule will increase confidence in the proper functioning of the markets. The Exchange believes the proposed additional Pre-Trade Risk Controls will assist Entering Firms and Clearing Firms in managing their financial exposure which, in turn, could enhance the integrity of trading on the securities markets and help to assure the stability of the financial system. As a result, the level of competition should increase as public confidence in the markets is solidified.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to expand the Exchange's Cabinet Proximity Option program.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for
Currently, the Exchange offers a Cabinet Proximity Option program where, for a monthly fee, customers can obtain an option for future use on available, unused cabinet space in proximity to their existing equipment. Cabinets reserved under the Cabinet Proximity Option program are unused cabinets that customers reserve for future use and can be converted to a powered cabinet at the customer's request. Under the program, customers can reserve up to maximum of 20 cabinets that the Exchange endeavors to provide as close as reasonably possible to the customer's existing cabinet space, taking into consideration power availability within segments of the datacenter and the overall efficiency of use of datacenter resources as determined by the Exchange. Should reserved datacenter space be needed for use, the reserving customer will have three business days to formally contract with the Exchange for full payment for the reserved cabinet space in contention or it will be reassigned. In making determinations to require exercise or relinquishment of reserved space as among numerous customers, the Exchange will take into consideration several factors, including: proximity between available reserved cabinet space and the existing space of a customer seeking additional space for actual cabinet usage; a customer's ratio of cabinets in use to those reserved; the length of time that a particular reservation(s) has been in place; and any other factor that the Exchange deems relevant to ensure overall efficiency in use of the datacenter space.
Currently, the Exchange offers reservations for low, medium, medium/high, or high density cabinets under the Cabinet Proximity Option program.
The Exchange offers the Cabinet Proximity Option program as a convenience to customers. No firms are required to reserve cabinets via the Cabinet Proximity Option program and it is only for those customers that choose to collocate directly with the Exchange. Participants can avoid reserving cabinets under this program (and the related fee) by (1) collocating but not reserving space in advance of needing it; (2) ordering cabinet space immediately and paying cabinet fees (without reserving in advance); (3) collocating indirectly through a vendor to defray costs; or (4) not collocating at all.
The Exchange intends to submit a fee filing in the future to establish related fees in the existing Cabinet Proximity Option Fees, in General 8, Section 1(d). Implementation of the proposal described herein to offer the Exchange's Cabinet Proximity Option program for cabinets with power densities greater than 10 kW would coincide with the subsequent fee filing.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Nothing in the proposal imposes any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which exchanges and other vendors offer colocation services as a means to facilitate the trading and other market activities of those market participants who believe that colocation enhances the efficiency of their operations. The Cabinet Proximity Option program is comparable to PNU cabinets offered by NYSE, as discussed above.
Nothing in the Proposal burdens intra-market competition because the Cabinet Proximity Option program is available to any customer and customers that wish to make reservations pursuant to the Cabinet Proximity Option program can do so on a non-discriminatory basis. Use of any colocation service is completely voluntary, and each market participant is able to determine whether to use colocation services based on the requirements of its business operations.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
SR-GEMX-2024-04 on the subject line.
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to expand the Exchange's Cabinet Proximity Option program.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Currently, the Exchange offers a Cabinet Proximity Option program where, for a monthly fee, customers can obtain an option for future use on available, unused cabinet space in proximity to their existing equipment. Cabinets reserved under the Cabinet Proximity Option program are unused cabinets that customers reserve for future use and can be converted to a powered cabinet at the customer's request. Under the program, customers can reserve up to maximum of 20 cabinets that the Exchange endeavors to provide as close as reasonably possible to the customer's existing cabinet space, taking into consideration power availability within segments of the datacenter and the overall efficiency of use of datacenter resources as determined by the Exchange. Should reserved datacenter space be needed for use, the reserving customer will have three business days to formally contract with the Exchange for full payment for the reserved cabinet space in contention or it will be reassigned. In making determinations to require exercise or relinquishment of reserved space as among numerous customers, the Exchange will take into consideration several factors, including: proximity between available reserved cabinet space and the existing space of a customer seeking additional space for actual cabinet usage; a customer's ratio of cabinets in use to those reserved; the length of time that a particular reservation(s) has been in place; and any other factor that the Exchange deems relevant to ensure overall efficiency in use of the datacenter space.
Currently, the Exchange offers reservations for low, medium, medium/high, or high density cabinets under the Cabinet Proximity Option program.
The Exchange offers the Cabinet Proximity Option program as a convenience to customers. No firms are required to reserve cabinets via the Cabinet Proximity Option program and it is only for those customers that choose to collocate directly with the Exchange. Participants can avoid reserving cabinets under this program (and the related fee) by (1) collocating but not reserving space in advance of needing it; (2) ordering cabinet space immediately and paying cabinet fees (without reserving in advance); (3) collocating indirectly through a vendor to defray costs; or (4) not collocating at all.
The Exchange intends to submit a fee filing in the future to establish related fees in the existing Cabinet Proximity Option Fees, in General 8, Section 1(d). Implementation of the proposal described herein to offer the Exchange's Cabinet Proximity Option program for cabinets with power densities greater than 10 kW would coincide with the subsequent fee filing.
The Exchange believes that its proposal is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Nothing in the proposal imposes any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which exchanges and other vendors offer colocation services as a means to facilitate the trading and other market activities of those market participants who believe that colocation enhances the efficiency of their operations. The Cabinet Proximity Option program is comparable to PNU cabinets offered by NYSE, as discussed above.
Nothing in the Proposal burdens intra-market competition because the Cabinet Proximity Option program is available to any customer and customers that wish to make reservations pursuant to the Cabinet Proximity Option program can do so on a non-discriminatory basis. Use of any colocation service is completely voluntary, and each market participant is able to determine whether to use colocation services based on the requirements of its business operations.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to expand the Exchange's Cabinet Proximity Option program.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Currently, the Exchange offers a Cabinet Proximity Option program where, for a monthly fee, customers can obtain an option for future use on available, unused cabinet space in proximity to their existing equipment. Cabinets reserved under the Cabinet Proximity Option program are unused cabinets that customers reserve for future use and can be converted to a powered cabinet at the customer's request. Under the program, customers can reserve up to maximum of 20 cabinets that the Exchange endeavors to provide as close as reasonably possible to the customer's existing cabinet space, taking into consideration power availability within segments of the datacenter and the overall efficiency of use of datacenter resources as determined by the Exchange. Should reserved datacenter space be needed for use, the reserving customer will have three business days to formally contract with the Exchange for full payment for the reserved cabinet space in contention or it will be reassigned. In making determinations to require exercise or relinquishment of reserved space as among numerous customers, the Exchange will take into consideration several factors, including: proximity between available reserved cabinet space and the existing space of a customer seeking additional space for actual cabinet usage; a customer's ratio of cabinets in use to those reserved; the length of time that a particular reservation(s) has been in place; and any other factor that the Exchange deems relevant to ensure overall efficiency in use of the datacenter space.
Currently, the Exchange offers reservations for low, medium, medium/high, or high density cabinets under the Cabinet Proximity Option program.
The Exchange offers the Cabinet Proximity Option program as a convenience to customers. No firms are required to reserve cabinets via the Cabinet Proximity Option program and it is only for those customers that choose to collocate directly with the Exchange. Participants can avoid reserving cabinets under this program (and the related fee) by (1) collocating but not reserving space in advance of needing it; (2) ordering cabinet space immediately and paying cabinet fees (without reserving in advance); (3) collocating indirectly through a vendor to defray costs; or (4) not collocating at all.
The Exchange intends to submit a fee filing in the future to establish related fees in the existing Cabinet Proximity Option Fees, in General 8, Section 1(d). Implementation of the proposal described herein to offer the Exchange's Cabinet Proximity Option program for cabinets with power densities greater than 10 kW would coincide with the subsequent fee filing.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Nothing in the proposal imposes any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which exchanges and other vendors offer colocation services as a means to facilitate the trading and other market activities of those market participants who believe that colocation enhances the efficiency of their operations. The Cabinet Proximity Option program is comparable to PNU cabinets offered by NYSE, as discussed above.
Nothing in the Proposal burdens intra-market competition because the Cabinet Proximity Option program is available to any customer and customers that wish to make reservations pursuant to the Cabinet Proximity Option program can do so on a non-discriminatory basis. Use of any colocation service is completely voluntary, and each market participant is able to determine whether to use colocation services based on the requirements of its business operations.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 7.31(a)(2)(B) regarding Limit Order Price Protection. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 7.31(a)(2)(B) (“Limit Order Price Protection”) to provide for the application of Limit Order Price Protection during the Core Trading Session even where a contra-side NBB (NBO) has not been established.
Currently, Rule 7.31(a)(2)(B) provides that a Limit Order to buy (sell) will be rejected if it is priced at or above (below) the greater of $0.15 or a specified percentage away from the National Best Offer (National Best Bid) (“NBO” and “NBB,” respectively),
The Exchange has recently received requests from market participants to modify this rule so that during the Core Trading Session, Limit Order Price Protection would apply even when no contra-side NBB or NBO has been established. In such cases, market participants have suggested that the Limit Order Price Protection calculation should use an alternate reference price, such as the last consolidated round-lot price of the trading day or the prior trading day's official closing price. That way, even if no contra-side NBB or NBO has been established, the Exchange would still apply Limit Order Price Protection using the best-available alternate reference price, thereby offering market participants greater protections against the execution of Limit Orders with aberrant prices during the Core Trading Session. The Exchange is aware that the Limit Order Price Protection rule on the MIAX Pearl equities exchange (“MIAX Pearl”) currently features such a hierarchy of reference prices, so that Limit Order Price Protection is applied to all Limit
In light of these requests from market participants, the Exchange now proposes to amend Rule 7.31(a)(2)(B) to provide a hierarchy of reference prices against which Limit Order Price Protection would apply during the Core Trading Session. As in the current rule, during the Core Trading Session, a Limit Order to buy (sell) would be rejected if it is priced at or above (below) the greater of $0.15 or a specified percentage (as set forth in the accompanying table) away from the NBO (NBB). But if such NBO (NBB) has not yet been established, the Exchange would use as the reference price the last consolidated round-lot price of that trading day, or, if none, the prior trading day's Official Closing Price.
As in the NYSE American filing, the Exchange does not propose for this change to apply during the Early and Late Trading Sessions. This is because with respect to both the Early and Late Trading Sessions, there is a higher likelihood that overnight news developments may move the market more than the percentages specified in the Limit Order Price Protection rule. If, in the absence of an NBO (NBB), such percentages were applied to the prior trading day's Official Closing Price, this might lead the Exchange to reject orders that are appropriately trying to establish a quote at the new market level. For this reason, the Exchange believes the current rule should continue to govern during the Early and Late Trading Sessions, such that if there is no contra-side NBO (NBB), Limit Order Price Protection will not be applied.
Accordingly, the Exchange proposes to amend and reorganize Rule 7.31(a)(2)(B) into three sub-sections, with sub-section (i) describing the relevant reference prices during the Core Trading Session, sub-section (ii) describing the relevant reference price during the Early and Late Trading Sessions, and sub-section (iii) describing the balance of the current rule.
Specifically, the Exchange proposes that new sub-section (i) of Rule 7.31(a)(2)(B) would provide that during the Core Trading Session, a Limit Order to buy (sell) will be rejected if it is priced at or above (below) the greater of $0.15 or a specified percentage (as set forth in the accompanying table) away from “(a) the NBO (NBB), or, if none, (b) the last consolidated round-lot price of that trading day, or, if none, (c) the prior trading day's Official Closing Price.”
The Exchange proposes that new sub-section (ii) of the rule would provide that during the Early and Late Trading Sessions, a Limit Order to buy (sell) will be rejected if it is priced at or above (below) the greater of $0.15 or a specified percentage (as set forth in the accompanying table) away from the NBO (NBB), and that Limit Order Price Protection will not be applied to an incoming Limit Order to buy (sell) if there is no NBO (NBB).
Finally, the Exchange proposes that the balance of the current rule be moved to new sub-section (iii) after the new subtitle “Applicability.”
The Exchange does not propose to make any other changes to the rule, nor does it propose any changes to the $0.15 or specified percentages used in the calculation of Limit Order Price Protection.
The Exchange anticipates implementing the proposed change in the first quarter of 2024 and, in any event, will implement the proposed rule change no later than the end of June 2024. The Exchange will announce the timing of such changes by Trader Update.
The Exchange believes that the proposed rule change is consistent with section 6(b) of the Act,
The Exchange believes that the proposed change would remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, protect investors and the public interest, because the use a substantially similar hierarchy of reference prices for the application of Limit Order Price Protection when no contra-side NBO or NBB has been established is currently in effect on MIAX Pearl and is the subject of an immediately-effective rule filing on NYSE American, and therefore is not novel.
The Exchange also believes that it would protect investors and the public interest for the Exchange to maintain the current Limit Order Price Protection rule for the Early and Late Trading Sessions. With respect to both the Early and Late Trading Sessions, there is a higher likelihood that overnight news developments may move the market more than the percentages specified in the Limit Order Price Protection rule. If, in the absence of an NBO (NBB), such percentages were applied to the prior trading day's Official Closing Price, this might lead the Exchange to reject orders that are appropriately trying to establish a quote at the new market level. For this reason, the Exchange believes that, for the protection of investors and the public interest, the current rule should continue to govern during the Early and Late Trading Sessions, such that if there is no contra-side NBO (NBB), Limit
The Exchange believes that the proposed rule change will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change would not address competitive issues but rather would enhance the Exchange's Limit Order Price Protection mechanism, to further protect market participants from aberrant prices and improve continuous trading and price discovery.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to expand the Exchange's Cabinet Proximity Option program.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Currently, the Exchange offers a Cabinet Proximity Option program where, for a monthly fee, customers can obtain an option for future use on available, unused cabinet space in proximity to their existing equipment. Cabinets reserved under the Cabinet Proximity Option program are unused cabinets that customers reserve for future use and can be converted to a powered cabinet at the customer's request. Under the program, customers can reserve up to maximum of 20 cabinets that the Exchange endeavors to provide as close as reasonably possible to the customer's existing cabinet space, taking into consideration power availability within segments of the datacenter and the overall efficiency of use of datacenter resources as determined by the Exchange. Should reserved datacenter space be needed for use, the reserving customer will have three business days to formally contract with the Exchange for full payment for the reserved cabinet space in contention or it will be reassigned. In making determinations to require exercise or relinquishment of reserved space as among numerous customers, the Exchange will take into consideration several factors, including: proximity between available reserved cabinet space and the existing space of a customer seeking additional space for actual cabinet usage; a customer's ratio of cabinets in use to those reserved; the length of time that a particular reservation(s) has been in place; and any other factor that the Exchange deems relevant to ensure overall efficiency in use of the datacenter space.
Currently, the Exchange offers reservations for low, medium, medium/high, or high density cabinets under the Cabinet Proximity Option program.
The Exchange offers the Cabinet Proximity Option program as a convenience to customers. No firms are required to reserve cabinets via the Cabinet Proximity Option program and it is only for those customers that choose to collocate directly with the Exchange. Participants can avoid reserving cabinets under this program (and the related fee) by (1) collocating but not reserving space in advance of needing it; (2) ordering cabinet space immediately and paying cabinet fees (without reserving in advance); (3) collocating indirectly through a vendor to defray costs; or (4) not collocating at all.
The Exchange intends to submit a fee filing in the future to establish related fees in the existing Cabinet Proximity Option Fees, in General 8, Section 1(d). Implementation of the proposal described herein to offer the Exchange's Cabinet Proximity Option program for cabinets with power densities greater than 10 kW would coincide with the subsequent fee filing.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Nothing in the proposal imposes any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which exchanges and other vendors offer colocation services as a means to facilitate the trading and other market activities of those market participants who believe that colocation enhances the efficiency of their operations. The Cabinet Proximity Option program is comparable to PNU cabinets offered by NYSE, as discussed above.
Nothing in the Proposal burdens intra-market competition because the Cabinet Proximity Option program is available to any customer and customers that wish to make reservations pursuant to the Cabinet Proximity Option program can do so on a non-discriminatory basis. Use of any colocation service is completely voluntary, and each market participant is able to determine whether to use colocation services based on the requirements of its business operations.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 7.19 to make additional pre-trade risk controls available to Entering Firms and Clearing Firms. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 7.19 to make additional pre-trade risk controls available to Entering Firms and Clearing Firms.
In 2020, in order to assist ETP Holders' efforts to manage their risk, the Exchange amended its rules to add Rule 7.19 (Pre-Trade Risk Controls),
The Exchange has recently received several requests from market participants to create two additional Gross Credit Risk Limit risk controls: one that includes only open orders and another that includes only executed orders. Market participants have explained that Entering Firms and Clearing Firms would benefit from having more granular gross credit risk controls available, which would allow them to set limits and breach actions based solely on open orders or executed orders, in addition to the Exchange's existing Gross Credit Risk Limit that includes both open and executed orders.
The Exchange notes that the MIAX Pearl equities exchange (“MIAX Pearl”) currently offers risk controls substantially similar to those proposed here. Specifically, MIAX Pearl offers its “Equity Members” and their “Clearing Members” the option to use a “Gross Notional Trade Value” risk check, which includes only executed orders, and a “Gross Notional Open Value” risk check, which includes only unexecuted orders, in addition to a “Gross Notional Open and Trade Value” risk check, for which both executed and unexecuted orders are included.
In light of these requests, the Exchange proposes to amend Rule 7.19(b)(1) to rename the existing Gross Credit Risk Limit as “Gross Credit Risk Limit—Open + Executed,” and to add two additional risk limits: “Gross Credit Risk Limit—Open Only” and “Gross Credit Risk Limit—Executed Only.”
Specifically, the Exchange proposes to amend and reorganize Rule 7.19(b)(1) as follows. First, the Exchange would amend the language in the first sentence of the rule to refer to plural Gross Credit Risk Limits, instead of just one. At the end of the first sentence, the Exchange would add that “[a]vailable Gross Credit Risk Limits include” the three types described in new sub-sections (A), (B), and (C).
Proposed sub-section (A) would define the “Gross Credit Risk Limit—Open + Executed” risk check to include unexecuted orders in the Exchange Book, orders routed on arrival pursuant to Rule 7.37(a)(1), and executed orders (just as the current Gross Credit Risk Limit does).
Proposed sub-section (B) would define the “Gross Credit Risk Limit—Open Only” risk check to include only unexecuted orders in the Exchange Book and orders routed on arrival pursuant to Rule 7.37(a)(1).
Proposed sub-section (C) would define the “Gross Credit Risk Limit—Executed Only” risk check to include executed orders only.
In addition, the Exchange proposes to make a conforming change to section (c)(1)(B) of the rule, to make plural the current singular reference to “Gross Credit Risk Limit.”
As with the Exchange's existing risk controls, use of the pre-trade risk controls proposed herein would be optional. The Exchange proposes no other changes to Rule 7.19 or its Commentary.
The proposed Pre-Trade Risk Controls described here are meant to supplement, and not replace, the ETP Holders' own internal systems, monitoring, and procedures related to risk management. The Exchange does not guarantee that these controls will be sufficiently comprehensive to meet all of an ETP Holder's needs, the controls are not designed to be the sole means of risk management, and using these controls will not necessarily meet an ETP Holder's obligations required by Exchange or federal rules (including, without limitation, the Rule 15c3-5 under the Act
The Exchange anticipates implementing the proposed change in the first quarter of 2024 and, in any event, will implement the proposed rule change no later than the end of June 2024. The Exchange will announce the timing of such changes by Trader Update.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
Specifically, the Exchange believes that the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system because the proposed additional Pre-Trade Risk Controls would provide Entering Firms and Clearing Firms with enhanced abilities to manage their risk with respect to orders on the Exchange. The proposed additional Pre-Trade Risk Controls are not novel; they are based on existing risk settings already in place on MIAX Pearl and market participants are already familiar with the types of protections that the proposed risk controls afford.
In addition, the Exchange believes that the proposed rule change will protect investors and the public interest because the proposed additional Pre-Trade Risk Controls are a form of impact mitigation that will aid Entering Firms and Clearing Firms in minimizing their risk exposure and reduce the potential for disruptive, market-wide events. The Exchange understands that ETP Holders implement a number of different risk-based controls, including those required by Rule 15c3-5. The controls proposed here will serve as an additional tool for Entering Firms and Clearing Firms to assist them in identifying any risk exposure. The Exchange believes the proposed additional Pre-Trade Risk Controls will assist Entering Firms and Clearing Firms in managing their financial exposure which, in turn, could enhance the integrity of trading on the securities markets and help to assure the stability of the financial system.
Finally, the Exchange believes that the proposed rule change does not unfairly discriminate among the Exchange's ETP Holders because use of the proposed additional Pre-Trade Risk Controls is optional and is not a prerequisite for participation on the Exchange.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. In fact, the Exchange believes that the proposal will have a positive effect on competition because, by providing Entering Firms and Clearing Firms additional means to monitor and control risk, the proposed rule will increase confidence in the proper functioning of the markets. The Exchange believes the proposed additional Pre-Trade Risk Controls will assist Entering Firms and Clearing Firms in managing their financial exposure which, in turn, could enhance the integrity of trading on the securities markets and help to assure the stability of the financial system. As a result, the level of competition should increase as public confidence in the markets is solidified.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Small Business Administration.
Notice of Federal advisory committee meeting: SBA Invention, Innovation, and Entrepreneurship Advisory Committee.
The U.S. Small Business Administration (SBA) will hold a virtual meeting of the SBA Invention, Innovation, and Entrepreneurship Advisory Committee on Tuesday, March 19, 2024. Members will convene as an independent source of advice and recommendations to SBA on matters supporting U.S. innovation, addressing commercialization hurdles and other vulnerabilities in the domestic investment and innovation ecosystem, and facilitating entrepreneurial access-to and participation-in federal innovation support and funding programs. The meeting will be virtual for members and streamed live to the public.
Tuesday, March 19, 2024, from 10:30 a.m. to 4:30 p.m. Eastern Time (ET).
The Invention, Innovation, and Entrepreneurship Advisory Committee will meet virtually and the meeting will be live streamed for the public. Register at
Brittany Sickler, Designated Federal Officer, Office of Investment and Innovation, SBA, 409 3rd Street SW, Washington, DC 20416, (202) 369-8862 or
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the SBA Invention, Innovation, and Entrepreneurship Advisory Committee (the “IIEAC”). The IIEAC is tasked with providingadvice, insights, and recommendations to SBA on matters broadly related to the U.S. startup and small business innovation ecosystem, and more specifically supporting innovation across the U.S.; developing and/or evolving SBA programs and services to address commercialization hurdles; addressing vulnerabilities and gaps in funding domestic invention and innovation; facilitating and enabling broad access and participation in federal innovation support and funding programs. The final agenda for the meeting will be posted on the IIEAC website at
Any member of the public may submit pertinent questions and comments concerning IIEAC affairs at any time before or after the meeting and participate in the livestreamed meeting of the SBA Invention, Innovation, and Entrepreneurship Advisory Committee on March 19. Comments may be submitted to Brittany Sickler at
Notice.
A determination has been made that a number of foreign persons have engaged in activities that warrant the imposition of measures pursuant to the Iran, North Korea, and Syria Nonproliferation Act (INKSNA).
These measures are effective February 27, 2024.
On general issues: Pam Durham, Office of Missile, Biological, and Chemical Nonproliferation, Bureau of International Security and Nonproliferation, Department of State, Telephone (202) 647-4930. For U.S. Government procurement ban issues: Eric Moore, Office of the Procurement Executive, Department of State, Telephone: (703) 875-4079. Email:
The INKSNA provides for sanctions on foreign entities and individuals for the transfer to or acquisition from Iran since January 1, 1999; the transfer to or acquisition from Syria since January 1, 2005; or the transfer to or acquisition from the DPRK since January 1, 2006, of goods, services, or technology controlled under multilateral control lists (Australia Group, Chemical Weapons Convention, Missile Technology Control Regime, Nuclear Suppliers Group, Wassenaar Arrangement) or otherwise having the potential to make a material contribution to the development of weapons of mass destruction (WMD) or cruise or ballistic missile systems. The latter category includes: items of the same kind as those on multilateral lists but falling below the control list parameters when it is determined that such items have the potential of making
On February 27, 2024, the U.S. Government applied the measures authorized in section 3 of the Iran, North Korea, and Syria Nonproliferation Act (Pub. L. 109-353) against the following foreign persons identified in the report submitted pursuant to section 2(a) of the Act:
PMC Wagner; and any successor, sub-unit, or subsidiary thereof;
Pavel Shevelin (Russian individual);
LLC Eltekhnord and any successor, sub-unit, or subsidiary thereof;
Rim Yo'ng-hyo'k (aka Rim Yong Hyok) (DPRK individual)
Russian Aerospace Forces (aka VKS); and any successor, sub-unit, or subsidiary thereof.
Accordingly, pursuant to section 3 of the Act, the following measures are imposed on these persons:
1. No department or agency of the U.S. Government may procure or enter into any contract for the procurement of any goods, technology, or services from these foreign persons, except to the extent that the Secretary of State otherwise may determine;
2. No department or agency of the U.S. Government may provide any assistance to these foreign persons, and these persons shall not be eligible to participate in any assistance program of the U.S. Government, except to the extent that the Secretary of State otherwise may determine;
3. No U.S. Government sales to these foreign persons of any item on the United States Munitions List are permitted, and all sales to these persons of any defense articles, defense services, or design and construction services under the Arms Export Control Act are terminated; and
4. No new individual licenses shall be granted for the transfer to these foreign persons of items the export of which is controlled under the Export Control Reform Act of 2018 or the Export Administration Regulations, and any existing such licenses are suspended.
These measures shall be implemented by the responsible departments and agencies of the U.S. Government and will remain in place for two years from the effective date, except to the extent that the Secretary of State may subsequently determine otherwise. These measures are independent of and in addition to any other sanctions imposed on such entities and/or individuals by other Federal agencies under separate legal authorities.
Notice of meeting.
The Federal Aviation Administration (FAA) and the National Park Service (NPS), in accordance with the National Parks Air Tour Management Act of 2000, announce the next meeting of the National Parks Overflights Advisory Group (NPOAG). This notification provides the date, location, and agenda for the meeting.
The NPOAG will meet on April 10-11, 2024. The meeting will take place in Conference Center Room 207 at the Volpe Center, 220 Binney St., Cambridge, MA. The meeting will be held from 8:30 a.m. to 5:00 p.m. on April 10, 2024, and from 8:30 a.m. to 12:30 p.m. on April 11, 2024. This NPOAG meeting is open to the public.
Sandra Fox,
The National Parks Air Tour Management Act of 2000 (NPATMA), enacted on April 5, 2000, as Public Law 106-181, required the establishment of the NPOAG within one year after its enactment. The Act requires that the NPOAG be a balanced group of representatives of general aviation, commercial air tour operations, environmental concerns, and Native American tribes. The Administrator of the FAA and the Director of NPS (or their designees) serve as ex officio members of the group. Representatives of the Administrator and Director serve alternating 1-year terms as chairperson of the advisory group.
The duties of the NPOAG include providing advice, information, and recommendations to the FAA Administrator and the NPS Director on; implementation of Public Law 106-181; quiet aircraft technology; other measures that might accommodate interests to visitors of national parks; and at the request of the Administrator and the Director, on safety, environmental, and other issues related to commercial air tour operations over national parks or tribal lands.
The agenda for the meeting will include, but is not limited to, an update on ongoing park specific air tour management plans or voluntary agreements, status of agency implementation of court approved plan/schedule, update on environmental review process and special purpose law consultations, and public comment review process.
Although this is not a public meeting, interested persons may attend. Because seating is limited, please contact the person listed under
If you cannot attend the NPOAG meeting, a summary of the meeting will be made available under the NPOAG section of the FAA ATMP website at:
Federal Aviation Administration (FAA), Department of Transportation.
Notice of public meeting.
This notice announces three meetings of the NextGen Advisory Committee (NAC).
The meetings will be held on March 21, July 11, and October 10, 2024, between 9 a.m.-2 p.m. eastern time. Request to attend the meeting virtually must be received by March 13, July 2, and October 2, 2024. Request for accommodations for a disability must be received by March 13, July 2, and October 2, 2024. Written materials requested to be reviewed by NAC Members before the meeting must be received no later than March 13, July 2, and October 2, 2024.
The meetings will be held at the Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, with a virtual option. Virtual meeting information will be provided on the NAC internet website at least one week in advance of the meeting. Information on the NAC, including copies of previous meeting minutes, is available on the NAC internet website at
Kimberly Noonan, NAC Coordinator, U.S. Department of Transportation, at
The Secretary of Transportation established the NAC under agency authority in accordance with the provisions of the Federal Advisory Committee Act, as amended, Public Law 92-463, 5 U.S.C. ch. 10, to provide independent advice and recommendations to the FAA and to respond to specific taskings received directly from the FAA. The NAC recommends consensus-driven advice for FAA consideration relating to Air Traffic Management System modernization.
At the meeting, the agenda will cover the following topics:
The detailed agenda will be posted on the NAC internet website at least one week in advance of the meeting.
The meeting is open to the public. Members of the public who wish to attend are asked to register via email by submitting their full legal name, country of citizenship, contact information (telephone number and email address), and name of their industry association or applicable affiliation, and if they would like to attend the meeting in person or virtually. Please email this information to the email address listed in the
Only NAC Members, NAC working group members, FAA staff who are providing briefings, and members of the public who registered and were selected to make a public statement will have the ability to speak. All other attendees will be able to listen only.
The U.S. Department of Transportation is committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, please contact the person listed in the
Any member of the public may present a written statement to the committee at any time. Written statements submitted by the deadline will be provided to the NAC members before the meeting. Written statements must be submitted to the person listed under the heading
Signed in Washington, DC.
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
Written comments should be submitted by April 5, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Jane Johnson by email at:
Once an airport qualifies as covered the collection frequency is as follows: it is required to send its initial competition plan as soon as possible. Upon approval by the FAA of the initial competition plan, the public agency must submit two (2) competition plan updates, in 18-month intervals, while it remains a covered airport. Once an airport has submitted, and the FAA has approved, its initial competition plan and the subsequent two (2) updates, a competition plan is only required if the airport (1) has filed a competitive access report as required by Section 424 of Vision 100, codified as 49 U.S.C. 47107(s) stating it has denied access to an air carrier for gates or facilities within the last six months; or (2) is executing a new master lease and use agreement, or significantly amending a lease and use agreement, including an amendment due to use of PFC financing of gates. If an airport loses its status as a covered airport, no further competition plan updates are required unless or until the airport becomes covered again.
Federal Highway Administration (FHWA), U.S. Department of Transportation (DOT).
Notice; request for information (RFI).
The FHWA issued regulations establishing minimum standards and requirements for certain electric vehicle (EV) chargers. Subsequent to the publication of this final rule, the Society of Automotive Engineers (SAE) published a Technical Information Report for a new connector standard, known as J3400, which multiple automakers have announced an intention to adopt in the coming years. To ensure the effective implementation of programs that are subject to the minimum standards and requirements and to inform a potential update to the minimum standards, FHWA, in coordination with the Joint Office of Energy and Transportation, is seeking additional information in five areas: on the expectations surrounding market availability for J3400 within EVs and EV chargers; on the technical compatibility of J3400 with existing regulations and safety considerations; on considerations regarding challenges and benefits of the implementation of J3400 at charging stations; on market demands for the continued availability of Combined Charging System (CCS) and J1772 connectors; and potential options for performance-based standards that can reduce the need for future regulatory updates or changes as technology evolves.
Comments must be received on or before April 5, 2024. Late-filed comments will be considered to the extent practicable.
To ensure that you do not duplicate your docket submissions, please submit comments by only one of the following means:
•
•
•
•
For questions about this notice, please contact Ms. Suraiya Motsinger, FHWA Office of Natural Environment, (202) 366-4287, or via email at
A copy of this notice, all comments received on this notice, and all background material may be viewed online at
Confidential Business Information (CBI) is commercial or financial
You may ask FHWA to give confidential treatment to information you give to the Agency by taking the following steps: (1) Mark each page of the original document submission containing CBI as “Confidential”; (2) send FHWA, along with the original document, a second copy of the original document with the CBI deleted; and (3) explain why the information you are submitting is CBI. The FHWA will protect confidential information complying with these requirements to the extent required under applicable law. Information collected in this RFI may also be shared with the Joint Office of Energy and Transportation and Department of Energy (DOE) consistent with Congressional direction that the minimum standards and requirements for EV chargers be developed in coordination with DOE. The Joint Office of Energy and Transportation will protect any such shared information in accordance with applicable DOE standards. If DOT receives a FOIA request for the information that the applicant has marked in accordance with this notice, DOT will follow the procedures described in its FOIA regulations at 49 CFR 7.29. Only information that is marked in accordance with this notice and ultimately determined to be exempt from disclosure under FOIA and 49 CFR 7.29 will not be released to a requester or placed in the public docket of this notice. Submissions containing CBI should be sent to: Ms. Suraiya Motsinger, FHWA, 1200 New Jersey Avenue SE, HICP-20, Washington, DC 20590 via mail, or
On February 28, 2023, FHWA published a final rule
As part of this rule, FHWA regulates the connector type used on EV chargers through 23 CFR 680.106(c) which states, “All charging connectors must meet applicable industry standards. Each Direct Current Fast Charger (DCFC) charging port must be capable of charging any Combined Charging System (CCS)-compliant vehicle and each DCFC charging port must have at least one permanently attached CCS Type 1 connector. In addition, permanently attached CHAdeMO (
Subsequent to the publication of 23 CFR part 680, the Society of Automotive Engineers (SAE) published a Technical Information Report (TIR)
To ensure FHWA has the most comprehensive and current information available, FHWA is specifically seeking detailed comments on the expectations surrounding market availability for J3400 within EVs and EV chargers, on the technical compatibility of J3400 with existing regulations, on considerations regarding challenges and benefits of the implementation of J3400 at charging stations, on market demands for the continued availability of CCS and J1772 connectors, and on potential options for performance-based standards that can reduce the need for future regulatory updates or changes as technology evolves. The FHWA is also interested in obtaining more information on the impact of the publication of the J3400 TIR in order to assess how the minimum standards and requirements for EV charging can address the evolving needs of EV charging consumers and industry.
The FHWA additionally requests information on what performance-based standards would best facilitate competition and innovation in EV markets, consistent with the Office of Information and Regulatory Affairs “Guidance on Accounting for
To ensure the effective implementation of programs that are subject to the minimum standards and requirements, FHWA requests information from the public, auto manufacturers, charger manufacturers, and others involved with or impacted by EV charging regarding the impact of the publication of the J3400 TIR. The FHWA is seeking additional information in five areas: (1) on the expectations surrounding market availability for J3400 within EVs and EV chargers, (2) on the technical compatibility of J3400 with existing regulations and safety considerations, (3) on considerations regarding challenges and benefits of the implementation of J3400 at charging stations, (4) on market demands for the continued availability of CCS and J1772 connectors, and (5) on options for performance-based standards.
a. What is the expected commercial availability and timeframe of J3400 EVSE products such as connector and cable assemblies, EV chargers, and adapters? Please be as specific (to month/year, anticipated volumes) as possible.
b. What safety standards will J3400 EVSE products need to be certified to and when will that certification occur? Are there any concerns with obtaining appropriate electrical and mechanical safety certifications for the J3400 connector?
c. What is the commercial availability and timeframe of vehicles with (i) J3400 inlets, and (ii) 800V system architecture? Please be as specific (to month/year, anticipated volumes) as possible.
d. Will future 800V vehicles be backwards compatible with 400V charging stations? If yes, for how long?
e. What, if any, opportunities do you see to commercial availability and use of J3400 connectors and chargers?
f. What, if any, barriers do you see to commercial availability and use of J3400 connectors and chargers?
g. Is there existing domestic manufacturing capacity to meet anticipated demand for J3400 connectors and chargers? If not, when do you expect this capacity to be available? How many companies have capability to ramp up production of J3400 ports, connectors, and/or adapters?
h. How might the ownership and exercise of intellectual property rights impact the development of J3400 EVSE products?
a. Do you foresee any challenges with J3400 specifically meeting the power delivery requirements in 23 CFR 680.106(d)? Please elaborate on these challenges with specific examples, data, etc.
b. Do you foresee any challenges with J3400 specifically meeting the interoperability requirements in 23 CFR 680.108? Are there any challenges with J3400 meeting other aspects of interoperability, including compatibility, safety, and performance of connectors/inlets/adapters, communications or security protocols, or support of vehicles designed to charge using CCS/J1772 connectors? Please elaborate on these challenges with specific examples, data, etc.
c. Do you foresee any other challenges with J3400 meeting other existing requirements in 23 CFR part 680? Please elaborate on these challenges with specific examples, data, etc.
d. Have any issues been identified or foreseen using a combined connector that accommodates both CCS Type 1 and J3400 connectors with one cable (as an example, combined connector designs such as Tesla's Magic Dock)? Is there a difference in performance or durability between the use of a combined cable with multiple connectors and the use of two separate cables (each with their own connector)? Please comment specifically about power level and reliability.
a. Is there a need to include J3400 connectors on all federally-funded chargers? Is there a difference between the use of J3400 connectors for DCFC or AC Level 2 charging?
b. Is it practical to retrofit an existing DCFC with a J3400 or other connector either in addition or as a replacement to an existing connector? What is the cost of installation to retrofit an existing charger with a J3400 or other connector in addition or as a replacement to an existing connector? Would retrofitted or added J3400 connectors on DCFC ports suffer from performance loss relative to natively installed CCS connectors? Are there other challenges with retrofitting an existing charger? If so, please describe challenges.
c. What is the cost of a DCFC with a CCS Type 1 connector? What is the anticipated cost of a DCFC with a J3400 connector? What is the anticipated cost of a charger that provides both CCS Type 1 and J3400 at each port? Are there differences in maintenance considerations between these different types of DCFCs?
d. What is the cost of an AC Level 2 charger with a J1772 connector? What is the anticipated cost of an AC Level 2 charger with a J3400 connector? What is the anticipated cost of a charger that provides both J1772 and J3400? Are there differences in maintenance considerations between these different types of AC Level 2 chargers?
e. What, if any, equity-related challenges or benefits may result from use of J3400 connectors? What are the benefits or challenges for persons with disabilities between using J3400 and CCS/J1772 connectors? What strategies could increase those benefits or mitigate the challenges? If each charging station has a specified number of each type of connector (J3400 and CCS Type 1/J1772), should accessible spots be required to have both connectors?
f. What are workforce needs associated with retrofitting or installing chargers to be J3400 compatible and maintaining those chargers once installed? Will existing training and certification programs need to be updated or amended to cover J3400 installation, operations, and maintenance?
g. Are there any compatibility, reliability, or safety concerns about charging vehicles that are designed to charge using CCS/J1772 connectors at new J3400 AC level 2 chargers or at J3400 DCFCs with an adapter?
h. What are the challenges, if any, in ensuring that J3400 will utilize ISO15118 cyber physical security protections such as TLS authorization and authentication?
a. Over time, what will be the expected continued demand for CCS/J1772 connectors?
b. Over time, what will be the expected market adoption of J3400 in new vehicle models? Please be specific in regard to the anticipated percentage of J3400 and CCS/J1772 vehicles by model year.
c. Over time, what will be the expected demand for J3400 connectors?
d. What is the anticipated useful life of the CCS, J1772, and J3400 connectors and cables that are currently in use (or that will be installed in the near future)?
e. What is the expected impact of the TIR to the market for vehicle models that were manufactured to utilize CCS/J1772 connectors?
a. If there is a need to include J3400 connectors on chargers, what are the advantages and disadvantages of the following design-based approaches?
Under Approach 2, what is the optimal ratio of J3400 connectors to CCS/J1772 connectors? Why?
If there is not a need to include J3400 connectors on chargers, what are the advantages and disadvantages of the following design-based approaches to including J3400, CCS/J1772, or other connectors alongside cables?
Are there alternative design-based approaches to accommodate J3400 and CCS/J1772 equipped vehicles?
b. Are there performance-based alternatives to specifying charging standards and communication standards (such as J3400, J1772, or ISO 15118) by reference that would support a convenient, affordable, reliable, and equitable EV charging network while reducing the need for future refinement to federal regulations?
c. Which performance-based alternative (
d. Should performance-based standards include requirements for achieving Key Performance Indicators most important to EV customers? If so, what should those Key Performance Indicators be?
a. Is there anything additionally that should be considered related to EV charging connector standards and technologies that is not covered in the above questions?
b. Are there any supply chain issues for EVs and EVSEs related to support for 800V architectures?
Office of the Secretary, Department of Transportation
Notice of public meeting.
DOT OST announces a virtual meeting of ACTE's Power of Community Subcommittee, which will take place via Zoom Webinar.
The meeting will be held Tuesday, March 26, 2024, from 12:00 to 2:00 p.m. Eastern Time. Requests for accommodations because of a disability must be received by Tuesday, March 19. Requests to submit questions must be received no later than Tuesday, March 19. The registration form will close on Monday, March 25.
The meeting will be held via Zoom webinar. Those members of the public who would like to participate virtually should go to
Sandra D. Norman, Senior Advisor and Designated Federal Officer, Departmental Office of Civil Rights, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, (804) 836-2893,
ACTE was established to provide independent advice and recommendations to the Secretary of Transportation about comprehensive, interdisciplinary issues related to civil rights and transportation equity in the planning, design, research, policy, and advocacy contexts from a variety of transportation equity practitioners and community leaders. Specifically, the Committee will provide advice and recommendations to inform the Department's efforts to:
Implement the Agency's Equity Action Plan and Strategic Plan, helping to institutionalize equity into Agency programs, policies, regulations, and activities;
Strengthen and establish partnerships with overburdened and underserved communities who have been historically underrepresented in the Department's outreach and engagement, including those in rural and urban areas;
Empower communities to have a meaningful voice in local and regional transportation decisions; and
Ensure the compliance of Federal funding recipients with civil rights laws and nondiscrimination programs, policies, regulations, and activities.
The agenda for the meeting will consist of:
Advance registration is required. Please register at
Office of the Secretary, Department of Transportation
Notice of public meeting.
DOT OST announces a virtual meeting of ACTE's Expanding Access Subcommittee, which will take place via Zoom Webinar.
The meeting will be held Thursday, March 21, 2024, from 2:00 to 4:00 p.m. Eastern Time. Requests for accommodations because of a disability must be received by Thursday, March 14. Requests to submit questions must be received no later than Thursday, March 14. The registration form will close on Wednesday, March 20.
The meeting will be held via Zoom Webinar. Those members of the public who would like to participate virtually should go to
Sandra D. Norman, Senior Advisor and Designated Federal Officer, Departmental Office of Civil Rights, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, (804) 836-2893,
ACTE was established to provide independent advice and recommendations to the Secretary of Transportation about comprehensive, interdisciplinary issues related to civil rights and transportation equity in the planning, design, research, policy, and advocacy contexts from a variety of transportation equity practitioners and community leaders. Specifically, the Committee will provide advice and recommendations to inform the Department's efforts to:
Implement the Agency's Equity Action Plan and Strategic Plan, helping to institutionalize equity into Agency programs, policies, regulations, and activities;
Strengthen and establish partnerships with overburdened and underserved communities who have been historically underrepresented in the Department's outreach and engagement, including those in rural and urban areas;
Empower communities to have a meaningful voice in local and regional transportation decisions; and
Ensure the compliance of Federal funding recipients with civil rights laws and nondiscrimination programs, policies, regulations, and activities.
The agenda for the meeting will consist of:
Advance registration is required. Please register at
Office of the Secretary, Department of Transportation
Notice of public meeting.
DOT OST announces a virtual meeting of ACTE's Interventions Subcommittee, which will take place via Zoom Webinar.
The meeting will be held Wednesday, March 27, 2024, from 12 to 2 p.m. eastern time. Requests for accommodations because of a disability must be received by Wednesday, March 20. Requests to submit questions must be received no later than Wednesday, March 20. The registration form will close on Tuesday, March 26.
The meeting will be held via Zoom Webinar. Those members of the public who would like to participate virtually should go to
Sandra D. Norman, Senior Advisor and Designated Federal Officer, Departmental Office of Civil Rights, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, (804) 836-2893,
ACTE was established to provide independent advice and recommendations to the Secretary of Transportation about comprehensive, interdisciplinary issues related to civil rights and transportation equity in the planning, design, research, policy, and advocacy contexts from a variety of transportation equity practitioners and community leaders. Specifically, the
Implement the Agency's Equity Action Plan and Strategic Plan, helping to institutionalize equity into Agency programs, policies, regulations, and activities;
Strengthen and establish partnerships with overburdened and underserved communities who have been historically underrepresented in the Department's outreach and engagement, including those in rural and urban areas;
Empower communities to have a meaningful voice in local and regional transportation decisions; and
Ensure the compliance of Federal funding recipients with civil rights laws and nondiscrimination programs, policies, regulations, and activities.
The agenda for the meeting will consist of:
Advance registration is required. Please register at
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Product Liability Losses and Accumulations for Product Liability Losses.
Written comments should be received on or before May 6, 2024 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of the should be directed to Sara Covington, at (202) 317-5744 or Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice.
An 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 OMB control number. Books or records relating to a collection of information must be retained as long as 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 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Refunds and Credits; Periods of Limitations; Financial Disability.
Written comments should be received on or before May 6, 2024 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224 or by email to
Requests for additional information or copies of the form should be directed to Sara Covington, at (202) 317-5744 or Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington DC 20224, or through the internet, at
The following paragraph applies to all the collections of information covered by this notice.
An 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 OMB control number. 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 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning credit for increasing research activities.
Written comments should be received on or before May 6, 2024 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of the form should be directed to Kerry Dennis at (202) 317-5751, or at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
The following paragraph applies to all the collections of information covered by this notice.
An 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 OMB control number. 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 26 U.S.C. 6103.
U.S.-China Economic and Security Review Commission.
Notice of open public hearing.
Notice is hereby given of the following hearing of the U.S.-China Economic and Security Review Commission. The Commission is mandated by Congress to monitor, investigate, and report to Congress annually on “the national security implications of the economic relationship between the United States and the People's Republic of China.” Pursuant to this mandate, the Commission will hold a public hearing in Washington, DC on March 21, 2024 on “China's Evolving Counter Intervention Capabilities and Implications for the U.S. and Indo-Pacific Allies and Partners.”
The hearing is scheduled for Thursday, March 21, 2024 at 9:30 a.m.
Members of the public will be able to attend in person at a location TBD or view a live webcast via the Commission's website at
Any member of the public seeking further information concerning the hearing should contact Jameson Cunningham, 444 North Capitol Street NW, Suite 602, Washington DC 20001; telephone: 202-624-1496, or via email at
ADA Accessibility: For questions about the accessibility of the event or to request an accommodation, please contact Jameson Cunningham via email at
Background: This is the third public hearing the Commission will hold during its 2024 reporting cycle. The hearing will begin with an assessment of China's capabilities and concepts to prevent, block, or blunt U.S. military actions in the Indo-Pacific. Next it will examine U.S. efforts to contest and defeat China's counter-intervention capabilities with a focus on China's perception of those efforts. Finally, it will consider the perspectives and strategies of key U.S. allies including Japan, the Philippines, and Australia on China's military capabilities and the implications for regional security architecture.
The hearing will be co-chaired by Vice Chair Reva Price and Commissioner Randall Schriver. Any interested party may file a written statement by March 21, 2024 by transmitting it to the contact above. A portion of the hearing will include a question and answer period between the Commissioners and the witnesses.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, FACA 5 U.S.C. ch. 10, that the Geriatric and Gerontology Advisory Committee will meet on April 10-11, 2024. The April meeting sessions will begin and end as follows:
This meeting is open to the public.
The purpose of the Committee is to provide advice to the Secretary of VA and the Under Secretary for Health on all matters pertaining to geriatrics and gerontology. The Committee assesses the capability of VA health care facilities and programs to meet the medical, psychological, and social needs of older Veterans, and evaluates VA programs designated as Geriatric Research, Education, and Clinical Centers.
Time will be allocated for receiving public comments on April 10, 2024, at
Any member of the public wishing to attend virtually or seeking additional information should email
Agricultural Marketing Service, Department of Agriculture (USDA).
Final rule.
The U.S. Department of Agriculture's (USDA or Department) Agricultural Marketing Service (AMS or the Agency) amends its Packers and Stockyards Act, 1921, regulations to prohibit undue prejudice and unjust discrimination against individuals on a prohibited basis unrelated to the quality of the service or product provided. The rule also identifies retaliatory practices that interfere with lawful communications, assertion of rights, and associated participation, among other protected activities, as unjust discrimination prohibited by the law. Finally, the rule identifies deceptive practices that violate the Packers and Stockyards Act with respect to contract formation, contract performance, contract termination, and contract refusal. The purpose of this rule is to promote inclusive competition and market integrity in the livestock, meats, poultry, and live poultry markets.
This rule is effective May 6, 2024.
S. Brett Offutt, Chief Legal Officer/Policy Advisor, Packers and Stockyards Division, USDA AMS Fair Trade Practices Program, 1400 Independence Ave. SW, Washington, DC 20250; Telephone: (202) 690-4355; or email:
The rise of concentration and changes in contracting practices in livestock and poultry markets over the last four decades have facilitated and exposed producers and growers (hereafter, producers unless otherwise noted) to increasing economic harms from exclusionary, prejudicial, or otherwise discriminatory conduct, as well as deceptive conduct, by packers, swine contractors, and live poultry dealers (hereinafter regulated entities, unless otherwise noted). The regulatory toolkit embodied in the Packers and Stockyards Act, 1921, as amended (P&S Act or the Act) (7 U.S.C. 181
On October 3, 2022, AMS published in the
AMS is issuing these regulations to enhance basic protections that modern livestock and poultry producers need to promote inclusive competition and market integrity. Specifically, this final rule will:
• Prohibit, as undue prejudices or disadvantages, actions that inhibit market access or actions that are otherwise adverse to covered producers on the basis of race, color, religion, national origin (including ethnicity), sex (including sexual orientation and gender identity, as well as pregnancy), disability, marital status, or age; or because of the covered producer's status as a cooperative, with certain narrow exceptions such as the provision of religious meats and the functions of Tribal governments;
• Prohibit, as unjust discrimination, retaliatory and adverse actions that interfere with lawful communications, assertion of rights, associational participation, and other protected activities;
• Prohibit, as deceptive practices, regulated entities employing false or misleading statements or omissions of material information in contract formation, performance, and termination; and prohibit regulated entities from providing false or misleading representations regarding refusal to contract; and
• Require recordkeeping to support USDA monitoring, evaluation, and enforcement of compliance with aspects of this rule.
AMS is adopting this final rule to promote inclusive competition and market integrity, as rational decision-making, so critical to economic success, can most effectively occur in a market free of the practices prohibited by this
This final rule is effective 60 days after publication in the
Market abuses of discrimination, retaliation, and deception can occur in livestock and poultry markets. Such conduct is amplified and exacerbated under increasingly concentrated livestock and poultry markets. Such markets are dominated by a few large packers and live poultry dealers. Additionally, changes in contracting practices, specifically bilateral contracting and vertical contracting that reaches farther into the production aspects of livestock and poultry, have given processors greater control over producers. These changes can exacerbate the impacts of discriminatory, retaliatory, and deceptive conduct by packers and live poultry dealers, which inhibits producers from fully participating in livestock and poultry markets or obtaining the full value of their livestock and poultry products and services. With few marketing options in concentrated markets, producers are more likely to suffer long lasting harm from market abuses by packers and live poultry dealers than would be the case in a marketplace that is more competitive.
A review of the historical structure of livestock and poultry markets shows how the risk of worsened competitive conditions or materially adverse effects to producers at the hands of a few large processors (livestock packers and live poultry dealers) has grown over time. In the late 1800s to early 1900s, the “Big Five”
The following table shows the level of concentration in the livestock and poultry slaughtering industries for 1980-2020 using four-firm Concentration Ratios (CR4).
The data are estimates of four-firm concentration ratios at the national level, but the relevant economic markets for livestock and poultry may be regional or local, where concentration may be higher than at the national level. The following figure shows the relative access that producers have to slaughter plants within various draw areas.
Half of all broiler growers have two or fewer processors for which they can grow broilers.
By the late 20th century and early 21st century, contracting practices were also changing. Bilateral and vertical contracting were becoming the increasingly dominant means to coordinate live animal supplies.
One of the notable structural changes over the course of the 20th century was the improvement in refrigeration technology. Refrigeration enabled meat packers to move away from the from Great Lakes and the Upper Midwest, where they could source large quantities of ice and build facilities closer to the centers of livestock production.
These changes had two implications over time. First, as processing plants moved from urban to rural areas, producers were more vulnerable to an exercise of monopsony power because the local and regional markets became more concentrated.
The broiler industry also grew quickly after the Second World War. Early on it adopted a production model in which live poultry dealers contracted with poultry growers to grow-out broilers, rather than a model of independent producers selling broilers on the open market. With most broiler growing contracts, the live poultry dealer provides the chicks, the feed, and veterinary services, while the grower provides labor, facilities, equipment, and energy necessary to turn the chicks into slaughter-ready birds. At first, live poultry dealers were often feed suppliers, but now most processors act as live poultry dealers. Overall, the reality is that live poultry dealers have extensive control over production through the contracting practices.
Furthermore, it is important to acknowledge the impact of a consolidating farm production landscape overall. With the livestock and poultry farming sectors consolidating over the last several decades, the aggregate number of producers has declined significantly, even as total production is stable or growing. Many factors driving the loss of producers in the marketplace are the same factors underlying the market changes referenced above and include productivity growth wrought by scientific and technological advances, economies of scale, and transportation improvements. As shown in Figures 2 and 3 below, over the last 60 years, changes in animal production have corresponded to declines on the order of
In the figure above, the intensity of shading indicates the magnitude of decrease (left) or increase (right), with shading intensity scaled individually to each map panel. Generally, the number of cattle and hog operations for every size class except the largest decreased in many counties across the U.S., while the number of operations for the largest size class increased in only a few counties. Owing to the limitations of available county-level data, the above map for cattle operations include both feedlot and cow-calf operations, of which only the first sell directly to packers in most instances. Feedlots and packers tended to locate closer to producers in the latter half of the 20th century. As feedlots became larger and more concentrated, the number of farms with fed cattle sales declined. For example, McBride found that from 1978-1992, as the distribution of cattle feedlots became geographically tighter, the number of counties contributing to half of cattle sales decreased from 73 counties in 1978 to just 44 counties in 1992, with a fourth
Data from Figure 3 clearly indicate a shift in livestock and poultry raising to larger farms. This shift has occurred in concert with an increase in bilateral and vertical contracting. Bilateral and vertical contracting facilitate the conditions in which discrimination and retaliation are more likely to restrict market opportunities of producers and cause them to earn less than the full value of their animals. It is harder to discriminate in the aggregated market of the stockyard than through bilateral contracting regimes. When producers are locked into long-term agreements with a single buyer, it is easier for buyers to discriminate on prohibited bases or retaliate in response to protected activities because they exercise considerably more leverage over producers. Buyer-seller relationships are more fixed, providing much less flexibility for producers. Furthermore, with the number of farms declining in number, the economic harms of discrimination and retaliation are more likely to be permanent as being denied a long-term contract may lead to permanent exclusion from the market. Smaller farms in particular may be more likely to be permanent casualties of discriminatory or retaliatory behavior in a consolidated farm context as buyers gravitate toward larger suppliers to more easily satisfy their volume requirements. Discriminatory or retaliatory behavior is more likely to harm producers economically because it is much harder to find alternative buyers in a world with fewer, bigger farms and fewer, bigger packers and live poultry dealers. This rule is not directly addressing consolidation at the farm level or concentration at the processor level, but in providing more protections to producers from discriminatory and retaliatory conduct, it is helping to prevent market exclusion.
A long-time scholar of these markets stated as early 2004 that the livestock and poultry markets appear to be by “invitation only.”
The P&S Act is a remedial statute enacted to address problems faced by farmers, producers, and other participants in the markets for livestock, meats, meat food products, livestock products in unmanufactured form, poultry, and live poultry; to protect the public from predatory practices; and to protect freedom for farmers and businesses to engage in the flow of commerce.
AMS finds that current regulations under the Act do not sufficiently address the many unduly prejudicial, unjustly discriminatory, and deceptive practices in the livestock and poultry industry. As discussed above, the combination of increased concentration and use of vertical contracts in livestock and poultry markets enhances regulated entities' ability to unjustly discriminate against or deceive market participants and effect significant harm upon
Discrimination and prejudice harm market participants and overall market integrity and efficiency. Discrimination is economically inefficient.
In comments to the proposed rule, multiple organizations spoke of the widespread economic harms resulting from discrimination and prejudice in livestock and poultry markets.
Rural Advancement Foundation International—USA, Comments on Proposed Rule: Inclusive Competition and Market Integrity, (AugJan. 20232), available at
As previously noted, this rule does not address every form of discrimination or prejudicial exclusion or disadvantage in the marketplace but focuses on providing clarity regarding certain specific discriminatory and prejudicial practices that AMS has identified in this final rule as essentially unjust, which offer no benefits to the competitive market or producers, and which undermine competition on the merits of the products and services that producers offer. Additionally, although the descriptive analyses set forth below do not address the prevalence or degree or prejudice for each and every prohibited basis, owing to the limitations of available data, AMS believes that leaving out any of the bases listed in this rule would be inappropriate. Not only would that be inconsistent with the Department's approach toward discrimination in other contexts, as repeatedly endorsed by Congress, but the resulting uncertainty could also open the door to those forms of discrimination in livestock, poultry, and related markets under the Act, which would be contrary to the purposes of this regulation and
AMS (including its predecessor agencies) has received complaints over the years of discrimination against producers, in particular in the poultry industry, and especially on the basis of race. The Agency has not always been able to act on these complaints for a variety of reasons. The Agency also believes that some complaints may have been suppressed due to the risks of retaliation, which are discussed below. As highlighted below, comments to this rulemaking affirmed the prevalence and remaining challenge of discrimination on prohibited bases.
Researchers have documented the history of discrimination against racial and ethnic minorities in agricultural markets. Multiple factors have contributed to the decline of non-white-owned farms, specifically to the decline of Black-owned farms, including the Homestead Act of 1862, the Morrill Land Grant Act of 1862, lack of legal protections for heirs' property, and limited access to capital through discriminatory lending practices.
Researchers have also documented some of the adverse outcomes, including economic outcomes, caused by discrimination. In the livestock sector, the results of historical prejudice and the risk of present-day prejudice are apparent when looking at data from the 2017 Census of Agriculture, which show that a small fraction of livestock farms with production contracts are operated by Black, Asian, American Indian, or Native Hawaiian producers (Figure 1).
Disparities are also found in income across racial and ethnic groups. It is difficult to disentangle historical discrimination—whether that be prejudicial administration of USDA farm policies, racial segregation laws, or discriminatory private lending policies, from current discrimination practiced by livestock and poultry companies. Figure 5 shows the percentage of livestock and poultry farms (omitting nonfamily farms) by the reported race or ethnicity, and categorized by the lowest level of Gross Cash Farm Income (GCFI), which is annual income before expenses, including cash receipts, farm-related cash income, and government payments.
Recent research conducted by the USDA's Office of the Chief Economist and presented at the Agricultural & Applied Economics Association
Differences in livestock and broiler prices could also be due, at least in part, to discrimination. Due to current data deficiencies, however, it is impossible to tell whether differences in prices received across ethnic or racial groups are due to current discriminatory practices, historic discrimination, or some combination thereof. These omitted variables may be correlated with race or ethnicity, and thus may account for a substantial portion of the price differentials. Additional data collection efforts may shed light on the role of omitted variables, such as animal size, thus helping to distinguish economic effects arising from current racial discrimination from disparate economic outcomes due to historical discrimination.
Gender is also a basis of discrimination in livestock and poultry markets. According to the 2017 Census, livestock and poultry operations where principal operators are female received significantly lower market value for the livestock and poultry they sell. Female principal operators in livestock and poultry earned 53 cents per operation for every dollar earned by male principal operators per operation. By comparison, in the broader U.S. population, females earn 77 to 82 cents for every dollar earned by men in 2022.
AMS also utilized a regression analysis showing support for disparities in income across different protected classes. Table 3 presents the empirical results of multivariate regression analysis of the 2017 Agricultural Census and other data by the USDA Office of the Chief Economist. Black and American Indian cattle and broiler producers, and Black and American Indian hog producers of owned hogs (hogs not sold under production contracts) all received lower prices for their livestock products relative to White producers. For example, Black and American Indian producers received around 5 percent lower broiler prices but no statistically significant decrease in payments for hogs delivered under production contracts. However, the effect of many animal quality variables, such as weight per animal, dressing percentage, and yield grade, cannot be controlled for under this analysis because the data is not in the Census of Agriculture or other data sets organized by race and ethnicity. Thus, endowment differences, such as better land and more capital, that represent the legacy of historical discrimination may account for a portion of these price differentials. Hawaiian contract hog producers received 68 percent higher prices even though producer location was controlled for in the analysis, but the analysis cannot control for some unknown factors associated with this relatively small cohort of producers that may account for this relatively large price effect.
The results of an analysis presented in Table 3 found there is a statistically significant and positive relationship between female operators and price received for the owned-hog market, which includes producers of both contracted and owned hogs (the regression accounted for whether the producer was on a production contract or not through an explanatory variable), but which examines the price impact only on owned-hogs sold.
The regression analysis used above to study the effect of sex on prices received in livestock and poultry markets also found a statistically significant negative relationship between age of a farm operator and price received in poultry and owned-hog markets, as well as a statistically significant negative relationship between the experience of a farm operator and price received in the contract hog market. That is, as producers and growers age in the owned-hog and poultry markets and gain experience in the contract hog market, average price received declines. However, the same finding was not evident in cattle markets, where the relationship between increasing producer age and price is positive and statistically significant.
Gender is also a basis of discrimination in livestock and poultry markets. According to the 2017 Census, livestock and poultry operations where principal operators are female received significantly lower market value for the livestock and poultry they sell. Female principal operators in livestock and poultry earned 53 cents per operation for every dollar earned by male principal operators per operation. By comparison, in the broader U.S. population, females earn 77 to 82 cents for every dollar earned by men in
Producers have also been targeted by processors that discriminate or retaliate against them for forming or being members of a cooperative because of the check on dominant firm bargaining power that cooperatives provide.
Regulated entity resistance to producer cooperatives is not difficult to understand—and indeed has been the basis for congressional action in the past. The increased bargaining power that cooperatives give to their members makes them a target for opposition or curtailment by regulated entities. In a market characterized by concentration of larger market intermediaries, cooperatives
Producers have indicated to AMS that increased use of cooperatives is necessary because of the rise of abusive conduct aggravated by concentration in the markets and the decline in marketing options for smaller producers. For example, small cattle producers have expressed their concern to AMS about packers' disparate treatment of large and small producers. Large packers have commonly shown limited interest in dealing with producers that operate on a smaller capacity. Packers often prefer to buy large numbers of animals at once to lower transaction costs,
Additionally, cooperatives counterbalance the ability of regulated entities to exert market power against smaller or more vulnerable producers. Facing the threat of such a counterbalance, regulated entities have over time stymied producers' ability to form and utilize cooperatives. AMS has heard numerous reports of regulated entities terminating growers' or producers' contracts for their attempts to form cooperatives, as well as reports of the chilling effect such action has on any future attempts to do so.
Numerous public comments on the proposed rule supported the prohibition of undue prejudice based on protected bases such as those described above. In expressing support for the proposed “market vulnerable individual (MVI)” approach to addressing undue prejudices, several agricultural advocacy groups recommended that AMS explicitly enumerate protected bases in its definition of MVI. MVI, as defined in the proposed rule, is a person who is a member, or who a regulated entity perceives to be a member, of a group whose members have been subjected to, or are at heightened risk of, adverse treatment because of their identity as a member or perceived member of the group without regard to their individual qualities. The organizations said these protected bases should include, but not be limited to, the protected classes of race, color, national origin, religion, sex, sexual orientation, disability, age, income derived from a public assistance program, and political beliefs.
Multiple commenters from the meat and poultry industry who opposed the MVI approach nevertheless indicated that they would support rules targeting discrimination on specific prohibited bases.
Discrimination on the bases of race, color, religion, national origin, sex (including sexual orientation and gender identity),
AMS finds that discrimination continues to occur through adverse actions described in the inexhaustive list offered in the final rule. The list includes offering contract terms that are less favorable than those generally or ordinarily offered, refusing to deal, performing under or enforcing a contract differently than with similarly situated producers, requiring modifications to contracts on terms that are less favorable than the existing contract with the covered producer or only offering to renew contracts on terms that are less favorable than those of the existing contract with the covered producer, and terminating or not renewing a contract.
As discussed further in Section VII—Comment Analysis, producers have indicated that regulated entities continue to engage in these types of discriminatory actions.
Many producers across all animal species have expressed concerns about being retaliated against for engaging in legitimate business and advocacy activities inextricably linked to livestock and poultry markets. Contract poultry growers and hog producers have expressed to USDA that they have experienced—and consistently fear—retaliation from live poultry dealers and packers for communicating with each other, with their dealer's and packer's competitors, and with governmental officials, as well as for forming associations and cooperatives, exercising contract or legal rights, or being a witness in proceedings against the regulated entity.
This is a persistent problem. As recently as April 2022, threats and fear of retaliation interfered with witness testimony at each of the House and Senate Agriculture Committees' hearings on livestock competition practices. In his opening remarks, House Agriculture Committee Chair David Scott noted, “We were supposed to have a 4th witness, a rancher, on our panel, but due to intimidation and threats to this person's livelihood, to this person's reputation, they chose not to participate out of fear. Witness intimidation is unacceptable. . . .”
The day before, Senator Deborah Fischer had stated, “I wish we had a Nebraska producer here, but as is noted in their letter, none of our producer members we encouraged to testify were willing to put themselves out front for fear of possible retribution from other market participants, an unfortunate reality of today's cattle industry.”
In response to the proposed rule, commenters expressed support and opposition for the proposal to establish prohibitions against retaliatory practices. Several industry associations opposed the proposed rule, indicating it is duplicative and therefore not necessary. These commenters contended the conduct addressed in the
In recent years, producers have been increasingly vulnerable to harms from retaliatory behavior due to the market power afforded regulated entities under contracts that can reach further down into livestock and poultry production and/or are bilateral. This is in contrast to past circumstances where these relationships were intermediated through an institution such as a stockyard (auction) subject to heightened regulatory duties around nondiscrimination.
As regulated entities have obtained greater control over the input industries, particularly in poultry, producers are increasingly dependent upon regulated entities for success. That dependence, in combination with high levels of debt, leaves producers vulnerable to the retaliation that regulated entities can exact through input distribution and in other ways. Growers have for years reported punitive delivery of inputs to deter their exercise of a wide range of legal rights and remedies that would enable them to earn the full value of their services.
Based on complaints and industry experience, AMS is aware that retaliation by regulated entities may take many forms, such as canceling contracts, selectively enforcing contract terms, refusing to deal or negotiate, or otherwise impairing an individual's or group of producers' ability to operate.
As discussed below in Section VII—Comment Analysis, in response to the proposed rule, commenters expressed extensive agreement with the need to establish prohibitions against retaliatory practices.
The Packers and Stockyards Act has long recognized that integrity and honesty are vital to the marketing of livestock and, therefore, to the efficiency with which these markets supply meat to the American consumer.
Poultry producers have complained to USDA over the years regarding unfavorable provision of inputs made to certain producers despite statements by live poultry dealers that there are no differences in treatment. Producers have also complained to USDA of terminations, suspensions, or reductions in flocks on pretexts—
As discussed in Section VII—Comment Analysis, comments underscored the need to address deceptive practices in this rulemaking.
Congress enacted the Act to promote fairness, reasonableness, and transparency in the marketplace by prohibiting practices that are contrary to these goals. AMS is issuing these regulations under the Act's provisions prohibiting undue prejudice, unjust discrimination, and deception to provide for clearer, more effective standards to govern the modern marketplace and to better protect, through compliance and enforcement, individually harmed producers.
Enacted in 1921 “to comprehensively regulate packers, stockyards, marketing agents and dealers,”
Section 407 of the Act provides that the Secretary “may make such rules, regulations, and orders as may be necessary to carry out the provisions of this [Act].” (7 U.S.C. 228(a)) The Secretary has delegated the responsibility for administering the Act to AMS. Within AMS, the Packers and Stockyards Division (PSD) of the Fair-Trade Practices Program has responsibility for the day-to-day administration of the Act. The current regulations implementing the Act are found in title 9, part 201, of the CFR. Therefore, based on the authority delegated to USDA by Congress to administer the Act, AMS is promulgating this rulemaking to amend part 201 to specifically clarify that discriminatory, deceptive, and retaliatory conduct, as defined in this rule, are violations of the Act.
Executive Order (E.O.) 14036, “Promoting Competition in the American Economy” (86 FR 36987, July 9, 2021), directs the Secretary to further the vigorous implementation of the Act. Accordingly, this final rule addresses the unfair treatment of farmers and improves competitive conditions in markets. This rule adds clarity to USDA's regulations concerning unjustly discriminatory practices, deceptive practices, and undue or unreasonable prejudices or disadvantages. E.O. 14036 underscored that “it is unnecessary under the... Act to demonstrate industry-wide harm to establish a violation of the Act and that the `unfair, unjustly discriminatory, or deceptive' treatment of one farmer” violates the Act. Among other policy goals in the E.O., this final rule is specifically intended to address the unfair treatment of farmers and make it easier for them to garner the full value of their animals. The Act is a remedial statute enacted to address problems faced by farmers, producers, and other participants in the markets for livestock, meats, meat food products, livestock products in unmanufactured form, poultry, and live poultry; to protect the public from predatory practices; and to help ensure a stable food supply. Thus, as academics and courts have noted, the Act has “tort-like provisions that are concerned with unfair practices and discrimination” that fulfill a “market facilitating function,” which Congress designed to prevent “market abuse.”
In the October 2022 proposal, AMS proposed amending 9 CFR 201 by adding a new subpart O, titled “Competition and Market Integrity,” and containing §§ 201.300 through 201.390. AMS proposed adding a Definitions section, § 201.302, containing the terms
AMS also proposed adding § 201.304, titled “Undue prejudices or disadvantages and unjust discriminatory practices,” to prohibit regulated entities from discriminating against a market vulnerable individual or a cooperative, detailing in proposed paragraph (a) types of prohibited actions. Paragraph (b) of the proposed regulation would prohibit regulated entities from retaliating against a covered producer because of the covered producer's participation in a producer association, protected activities, including assertion of rights under the Act, and lawful communication. Proposed paragraph (b) also provided examples of prohibited retaliatory actions. Proposed paragraph (c) included a requirement that regulated entities retain records of compliance with paragraphs (a) and (b) for no less than five years from the date of record creation.
AMS also proposed adding § 201.306, titled “Deceptive practices,” prohibiting a regulated entity from employing a false or misleading statement or omission of material information necessary to make a statement not false or misleading during contract formation,
Finally, AMS proposed adding § 201.390, titled “Severability.” This provision was intended to inform reviewing courts that if any provision of subpart O was declared invalid, or if the applicability of any of its provisions, or any components of any provisions, to any person or circumstances was held invalid, the validity of the remaining provisions of subpart O or their applicability to other persons or circumstances would not be affected. Severability provisions are typical in modern AMS regulations. AMS regulations often cover several different topics in a subpart. This provision was added because the regulations in subpart O are designed to address several different types of violations under the Act. Because these violations address similar underlying developments in the livestock and poultry markets—namely, abusive practices facilitated by increased vertical integration and horizontal concentration—these violations were suitable for joining in a single rulemaking. However, each could be viewed as its own stand-alone rulemaking and therefore should be severable.
Upon consideration of public comments on the proposed rule, AMS modified some of its proposed provisions to derive this final rule. These changes are outlined below.
AMS is making the following changes to the proposed rule based on the agency's analysis of the issues raised by commenters.
With respect to the proposed regulations regarding undue prejudice and unjust discrimination, § 201.304, several commenters expressed concern that the definition of “market vulnerable individual (MVI)” as the basis for prohibiting undue prejudice and discrimination was too broad and ambiguous and could lead to an avalanche of litigation. To simplify this section, the final rule uses a delineated set of protected bases against undue prejudice and discrimination that were discussed in the proposed rule: race, color, national origin, religion, sex, sexual orientation, gender identity, age, disability, and marital status. These delineated bases reflect the Statement of General Policy Under the Packers and Stockyards Act published by USDA in 1968 (9 CFR 203.12(f)) and USDA's Conducted Programs Statement, and reflect a general congressional policy as indicated in other statutory sources (discussed below).
AMS is adopting the aforementioned specific bases, as opposed to MVI, because the specific prohibited bases offer clearer, more workable standards to achieve the same goal set forth and specifically articulated in the proposed rule, but in a manner that will facilitate compliance by regulated entities and better enable producers to exercise their rights under the Act. As AMS explained in the proposed rule, the principal purpose of the MVI approach was to address prejudices in the marketplace against producers that are more vulnerable to such treatment and to stop unjust discrimination. AMS views vulnerability to adverse marketplace treatment to include, but not be limited to, exclusion or disadvantage on the basis of race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, marital status, or age, or on the basis of the covered producer's status as a cooperative. AMS initially adopted the MVI approach because it believed that the proposed rule's flexible approach to resolving marketplace vulnerabilities offered producers protection in an ever-evolving market. The proposed approach had the advantage of being responsive to the particular facts of given cases and particular markets over time.
As part of the rulemaking process, however, AMS sought comment on whether this was the best approach. AMS requested comment on whether it should “delineate specific categories of vulnerable producers on the basis of membership in groups that have historically been subject to adverse treatment owing to racial, ethnic, gender, or religious prejudices.” (87 FR 60010, Oct. 3, 2022) AMS also sought comment on “whether this regulation should ban discrimination against specific classes, such as on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, age, disability, marital status, or family status. Such an approach would differ from the market vulnerable individual approach and would instead more closely follow the civil rights laws that prohibit prejudicial discrimination against certain protected classes.”
After considering the comments on both the MVI approach and on specific delineated bases, AMS determined that MVI is not sufficiently clear enough to meet the objectives of this regulation. The enumeration of specific prohibited bases provides more clarity and certainty by limiting the scope of the rule to prohibited adverse actions against all producers on the basis of their membership of a protected class, in line with existing civil rights requirements. Commenters, such as a meat industry trade association, a poultry industry trade association, and a live poultry dealer, criticized the proposed rule's MVI definition for being vague and ambiguous and potentially exposing their businesses to an unworkable standard that could potentially encompass a wide range of covered producers far beyond what the Agency appeared to be contemplating in the proposed rule. In contrast, these commenters indicated that an approach based on specific classes, such as race, sex, sexual orientation, or religion, would be clearer and would follow the precedent of civil rights laws already in place while protecting all producers.
Multiple agricultural advocacy organizations also expressed approval of these protected classes as the prohibited bases for discrimination when responding to the proposed rule's solicitation of responses on this issue, saying discrimination against individuals in these groups should be clearly recognized so those individuals do not have to continually prove discrimination and prejudice against them based on the characteristic that makes them vulnerable in the market. AMS agrees that the bases adopted in the final rule reflect genuine vulnerability to market exclusion and have no competitive benefit.
AMS also notes that some commenters interpreted the MVI approach as potentially providing protection to small producers on the basis that small producers were vulnerable to discrimination in the form of the same kinds of adverse treatment proposed to be prohibited in this rule. While AMS is sympathetic to the plight of small producers' challenges in accessing fair markets, AMS did not intend this rule to address those concerns (as also discussed below in Section VII—Comment Analysis). Basing the rule on a term that gave rise to such disparate interpretations underlined the necessity of utilizing the more specific bases set forth in the proposed rule's alternative formulation.
Additionally, AMS notes that these prohibited bases are now widely accepted standards of non-discrimination at USDA and in the U.S. economy more broadly. AMS adopted many of these as part of its 1968 Statement of General Policy.
Accordingly, to achieve the same goal that the Agency set forth in the proposed rule through both MVI and the alternative formulation, AMS is now adopting the alternative formulation: race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, marital status, or age of the covered producer; or because of the covered producer's status as a cooperative.
In § 201.304(a)(2), AMS made three changes to the provisions regarding prohibited actions taken on a prejudicial basis. First, in paragraphs (a)(2)(i) through (iii), AMS proposed to prohibit offering contracts that are less favorable than those generally or ordinarily offered, refusing to deal, and differential contract performance or enforcement, when each occurred on a prohibited basis. AMS is revising each of these provisions to provide clarity and uniformity across this final rule with respect to a comparison to similarly situated producers and also to ensure parallel language with the retaliation adverse actions under § 201.304(b)(3). Paragraph (a)(2)(i) is revised to read “Offering contract terms that are less favorable than those generally or ordinarily offered to similarly situated producers; paragraph (a)(2)(ii) is revised to read “Refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers”; and paragraph (a)(2)(iii) in the final rule is revised to read “performing under or enforcing a contract differently
Second, AMS is adding a new paragraph (a)(2)(iv), which prohibits—when it occurs on a prohibited basis—“requiring a contract modification or renewal on terms less favorable than similarly situated covered producers.”
Third, AMS is adding a new paragraph (a)(2)(vi), which prohibits regulated entities from taking “any other action that a reasonable covered producer would find materially adverse.” This provision represents a logical outgrowth from the proposed rule, which had indicated that the “prejudice or disadvantage with respect to paragraph (a)(1) of this section includes the following actions.” As AMS explained in the proposed rule, AMS believes that the type of harm to a producer will not be difficult to identify when it occurs based upon the facts and circumstances, and thus provided an exemplary list to aid in identification and enforcement under the rule. Such a list was not intended to be all encompassing. However, in response to comments, AMS has recognized that such an open-ended approach may create too much uncertainty and undermine compliance and enforcement. AMS is replacing the use of “includes” with an additional, more flexible provision that provides a broader yet not unlimited range of possible harms. AMS's approach is in response to comments that adverse treatment of producers by regulated entities can occur outside the confines of the contractual relationship. Such conduct could include, for example, interference by a regulated entity into regulatory matters of significant material importance to producers. Several public commenters wanted more producer protections incorporated into § 201.304(a)(2). This provision provides a broad and flexible approach to these prohibitions and allows for “material” to be determined by the facts and circumstances of each case while staying within the scope of the proposed rule's intent around harms to producers under unjust discrimination and undue prejudice deriving from adverse actions.
Commenters suggested that AMS include exceptions to the prohibition on undue prejudice and unjust discrimination. In response to these comments and the shift from MVI to identifying specific prohibited bases, AMS decided to provide specific exceptions from the prohibition in two circumstances. New § 201.304(a)(3) states that the following actions by a regulated entity do not prejudice, disadvantage, inhibit market access, or constitute adverse action under § 201.304(a)(1): (i) fulfilling a religious commitment relating to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry; (ii) a Federally-recognized Tribe, including its wholly or majority-owned entities, corporations, or Tribal organizations, performing its Tribal governmental functions.
In shifting from MVI toward specific prohibited bases, AMS identified the need to provide certain exceptions from the prohibition. The proposed MVI was a flexible standard that permitted the Agency to evaluate the facts and circumstances of a particular case and whether the exclusion or disadvantageous contracting arrangement was based on the characteristics of the producer. Specifying delineated prohibited bases provides greater clarity, yet in doing so, it eliminates a degree of flexibility that could be valuable in a small set of circumstances. Accordingly, the Agency is adopting two specific exceptions to recognize circumstances that do not give rise to unjust discrimination. AMS asked questions about both areas in the proposed rule, highlighting to commenters that the Agency recognized the potential for additional adjustments to be made in those areas.
First, AMS is providing a specific exception to recognize the important role ritual slaughter plays in certain religious traditions and ensure that religiously significant meats—such as kosher, halal, and Amish meats—are not impacted by the rule's prohibition on discrimination on the basis of the producer's religion. According to AMS subject matter experts, halal slaughterers, for example, express a legitimate, religiously grounded preference for livestock and poultry raised by operators of faith,
To ensure clarity in its application, this rule respects longstanding jurisprudence surrounding Tribal sovereignty and the political relationship that a Tribe has with its members that secures the right for Tribal entities to preference Tribal members. To ensure that it is not read in contradiction with existing jurisprudence, the rule explicitly specifies that Tribal governments can engage in practices related to livestock, poultry, and meats with respect to non-Tribal entities or non-Tribal descendants. The prohibition on discrimination on the basis of race or color would be read to protect a person from discrimination for being of Native American descent, but not on preferential treatment given to Tribal members based on their political classification. This matter was specifically raised by, and is responsive to, Tribal governments during the Tribal consultation that AMS conducted and is described below under “VII.C.—Executive Order 13175—Consultation and Coordination with Indian Tribal Governments.”
AMS recognizes that this rulemaking cannot foresee the range of unique or extenuating circumstances that may present in agricultural markets. Commenters stated that rapidly changing livestock and poultry markets may require an exception to the prohibition against undue prejudice or disadvantage on a protected basis. However, AMS did not identify, from the comments or based on its
AMS proposed in § 201.304(b)(1) to prohibit retaliation against a covered producer that occurs because of the covered producer's participation in protected activities “to the extent that these activities are not otherwise prohibited by Federal or state law, including antitrust laws.” In the final rule, AMS modified the language of this provision to move the exception for Federal or State law, including antitrust laws, to paragraph (b)(2) and to add Tribal law to the types of law identified in this exception. AMS is adding this language to make explicit the applicability of Tribal law in this circumstance. Additionally, AMS changed “because of” to “based upon” both in response to comments and to align with its approach in § 201.304(a) and embodied in § 201.304(c). AMS proposed “based upon” in § 201.304(a) and “by employing” in § 201.304(c) to capture actions where the prohibited bases form a material part of the action—discrimination or prejudice, or as part of the deceptive practice. Section 201.304(b) is designed to achieve the same goal. AMS also received comments recommending broad protections for covered producers from retaliatory actions, including where the retaliation was a part of the decision to take an adverse action. AMS further underscores that “based upon the covered producer's participation in an activity . . .” covers threats that would reasonably dissuade or chill a covered producer from participating in the activities.
Under proposed § 201.304(b)(2)(i), AMS proposed to establish as a protected activity a producer's communication with a government agency on matters related to livestock, meats, or live poultry or petitions for redress of grievances before a court, legislature, or government agency. Commenters requested that AMS clarify that this protection covers communication with any sector or level of government, including State governments. AMS intends for this regulation to include protections for communications with any level of government, including any government committee or official. In this final rule, AMS is aligning the use of the terms “court, legislature, or government agency” and simplifying the language to say, “government entity or official.” This change ensures that protected communications may occur with any of the three branches of government, any level of government, and with individual government officials, including committees and members of a legislature.
AMS requested public comment on whether the final rule should protect producers who choose not to participate in protected activities. In response to public comment supporting this proposal, AMS has revised § 201.304(b)(2)(ii) to protect a producer's right to refuse a regulated entity's request to engage in communication with a government entity or official that is not required by law, and § 201.304(b)(2)(iii) to protect a producer's right to form or join, or to refuse to form or join, a producer or grower association or organization. Proposed § 201.304(b)(2)(ii), which protected a producer's assertion of any of the rights granted under the Act or this part, or assertion of contract rights, is renumbered as paragraph (b)(2)(vii) in the final rule.
AMS proposed in § 201.304(b)(2)(v) to protect producer communication or negotiation with a regulated entity for the purpose of exploring a business relationship. In response to public comment, AMS added in the final rule protection for communicating; negotiating; or contracting with a regulated entity, another covered producer, or with a commercial entity or consultant; for the purposes of exploring or entering into a business relationship. Commenters asserted that, as proposed, the protected activity was “unreasonably narrow” and that expanding this protection would “help ensure that covered producers may
Under proposed § 201.304(b)(3), AMS identified types of prohibited retaliatory conduct. Commenters expressed concern regarding the lack of clarity of these proposed prohibitions, with some saying the prohibitions were too broad, some arguing that the rule should provide even more flexibility, and some supporting the introduction of a “catch-all clause” to provide additional protection against retaliatory behavior. The final rule adds language to paragraph (b)(3)(ii) to prohibit performing under or enforcing a contract differently than with
The final rule also revises the provision prohibiting a regulated entity from refusing to deal with a covered producer by adding the language, “on terms generally or ordinarily offered to similarly situated covered producers” (paragraph (b)(3)(iv) in the final rule). In response to comments, AMS agrees that the rule as proposed provided too great a latitude for a regulated entity to engage in retaliation because a regulated entity could, for example, satisfy the proposed rule by simply offering highly unfavorable terms to the covered producer. AMS believes that this revision provides broader coverage regarding the most common circumstances that producers may encounter in their business dealings in which regulated entities may attempt to exact retaliation. It would also cover circumstances where the “similarly situated producer” was the covered producer's own prior status quo circumstance with the regulated entity before the covered producer engaged in the protected activity. AMS is also aligning refusal to deal under paragraph (a)(2)(ii) to address the similar risk of evasion.
Similarly, commenters requested that AMS add a regulation regarding contract modification, or contract renewal. AMS has amended proposed § 201.304(b)(3) to add a new paragraph (b)(3)(iii) to clarify that requiring a contract modification or a renewal on terms less favorable than for similarly situated producers is covered.
In making these changes, the final rule provides a greater degree of specificity regarding the type of conduct the rule prohibits. AMS is not, however, providing the degree of specificity requested by commenters regarding unfavorable contract terms because it is impractical to name every action a malicious actor could use to retaliate against a producer, and providing this level of detail is not necessary to enforce the rule.
AMS made editorial changes to the text of several proposed regulations to improve clarity and readability. For instance, in the definition of
AMS also made several non-substantive clarifying changes to the wording of prohibited contractual deceptive practices in paragraphs (b) and (c) of § 201.306—Deceptive practices. These changes are identical under
Lastly, AMS made a technical change to the table of contents for subpart O. To avoid confusion, AMS is including §§ 201.303 and 201.305 in the table of contents as reserved sections to indicate the gaps between §§ 201.302, 304, and 306 are deliberate and that sections have not been inadvertently omitted.
Under the authority of the Act, this rule adds a new subpart O to AMS's regulations in 9 CFR 201, titled “Competition and Market Integrity,” and consisting of §§ 201.300 through 201.390. This section summarizes the substantive provisions of the new subpart.
Section 201.302 defines three terms for subpart O:
AMS defines
Section 201.304(a) addresses the unique and often difficult to prove discriminatory conduct that has long existed in the agricultural sector by prohibiting specific bases of prejudicial action. Paragraph (a) also lists prohibited actions taken on a prejudicial basis and provides clarification on the types of actions that do not constitute prohibited action taken on a prejudicial basis. In doing so, AMS is clarifying the application of the Act, better empowering producers to protect themselves, and encouraging companies to adopt more robust compliance practices to snuff out conduct prohibited by the Act in its incipiency, before it can distort markets in the aggregate. In particular, this rule addresses the longstanding and often difficult to counter forms of exclusion that have plagued the agricultural sector for decades. AMS intends for this rule to support positive trends toward inclusivity in the marketplace. Prejudices and disadvantages based upon the producer's protected characteristics or status as a producers' cooperative have no place in today's modern agricultural markets.
The Act, through section 202(a) and (b), broadly prohibits certain practices or devices, including undue or unreasonable prejudices and disadvantages and unjust discrimination. Section 202(a) and (b) of the Act identifies several prohibited actions with respect to livestock, meats, meat food products, or livestock products in unmanufactured form, or for any live poultry dealer with respect to live poultry. In this rule, AMS is prohibiting specific undue and unreasonable prejudices and disadvantages, and unjust discrimination against any covered producer on the basis of certain categories of characteristics or attributes broadly and firmly established as unjust in a modern economy. This regulatory action implements Congress's intent, expressed through the Act, to stop unjust discrimination and undue prejudice by packers and live poultry dealers against livestock producers and poultry growers.
In enacting the Act, Congress cast a wide net to capture all acts of unjust discrimination and undue or unreasonable prejudice against any particular person. There is no indication that Congress intended to exempt any discriminatory conduct taken by regulated entities against producers covered under the Act.
In
The Act contains similar, but broader, language than sec. 3 of the ICA. Section 202 of the Act reads, “It shall be unlawful for any packer or swine contractor with respect to livestock, meats, meat food products, or livestock products in unmanufactured form, or for any live poultry dealer with respect to live poultry, to: (a) Engage in or use any unfair, unjustly discriminatory, or deceptive practice or device; or (b) Make or give any undue or unreasonable preference or
As shown in Table 4, unlike the ICA, the Act in secs. 202(a) and (b) prohibits undue or unreasonable prejudices or disadvantages
This rule sets forth specific prohibitions on prejudicial or discriminatory acts or practices against individuals that are sufficient to demonstrate violation of the Act without the need to further establish broad-based, market-wide prejudicial or discriminatory outcomes or harms. The prohibitions in this rule on regulated entities adversely treating individual producers address the types of harms the Act is intended to prevent. AMS finds that adverse acts on these bases are essentially unjust and unduly prejudicial, and actionable at the individual level. Moreover, AMS
In determining the bases for protection against discrimination under the Act, AMS drew insight initially from the Statement of General Policy Under the Packers and Stockyards Act published by the Secretary in 1968 (Statement of General Policy) (9 CFR 203.12(a)), which states that the Act provides that all stockyard services furnished at a stockyard “shall be reasonable and nondiscriminatory and stockyard services which are furnished shall not be refused on any basis that is unreasonable or unjustly discriminatory.”
The Statement of General Policy reflects the current USDA policy on the enforcement of the Act. The Statement of General Policy provides in part that it is a violation of secs. 304, 307, and 312(a) of the Act for a stockyard owner or market agency to discriminate, in the furnishing of stockyard services or facilities or in establishing rules or regulations at the stockyard, because of
While this part of the Statement of General Policy applies to violations of secs. 304, 307, and 312(a) of the Act (related to the provision of services and facilities at stockyards on an unreasonable and discriminatory basis), almost identical prohibitive language is used in sec. 202 of the Act. Section 202 pertains to packers, swine contractors, and live poultry dealers. Section 202(a) of the Act prohibits any unjustly discriminatory practice or device with respect to livestock, meats, meat food products or livestock products in manufactured form, or live poultry.
AMS also considered USDA's general regulatory prohibition against discrimination in USDA programs, which governs how USDA provides services to producers. In 1964, USDA prohibited discrimination on the basis of race, color, and national origin in its Federally conducted activities by adopting Title VI principles.
AMS interprets the Act in light of legislative mandates that emerged over the last 30 years directing USDA to make extra efforts to ensure that members of the aforementioned groups have equal access to USDA's services and agricultural markets generally.
The definitions and coverage in these statutes vary to some extent. Some focus principally on members of groups that have experienced racial or ethnic prejudices, while others address gender prejudices. Overall, these statutes and Congressional deliberations provide useful reference for USDA to most effectively carry out the Act, which outlaws undue prejudice against any person in any respect. For example, in the congressional hearings preceding the Act's passage, opposing members argued against the Act because producers were already protected by the ICA, which guaranteed “equal rights on the railroads to every man, woman and
Additionally, in crafting the final rule, AMS was informed by the provisions of two additional laws that fall under the enforcement of USDA with respect to livestock and poultry. The first is ECOA. ECOA prohibits a creditor from discriminating in the provision of credit on the basis of race, color, religion, national origin, sex (which includes sexual orientation and gender identity), marital status, or age, because the applicant's income derives all or in part from a public assistance program, or because the applicant has in good faith exercised any right under ECOA.
Secondly, AFPA protects producers from retaliation by certain market intermediaries, defined as handlers, for being members of a cooperative or seeking to form a cooperative.
AFPA provides enhanced protections to those seeking to form a cooperative. In particular, that statute prevents handlers from performing certain types of pricing and contract discrimination, coercion, and other practices that undermine cooperatives. As noted previously, the Act intended to improve the agricultural market and includes associations in the definition of “person” when referred to in the Act. The Act affords cooperative associations the same protections against discrimination as are afforded to all other covered producers.
In interpreting the Act in light of the aforementioned policy direction, AMS has sought to stamp out market exclusion on prohibited bases. This final rule establishes a prohibition of undue prejudice or unjust discrimination against covered producers on the bases of race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, marital status, or age; or because of the covered producer's status as a cooperative. Transitioning from the proposed rule's use of the more flexible “market vulnerable individual” to the more specific list of delineated terms, the final rule interprets the Act consistent with the antidiscrimination mandates in other related statutes, including the ECOA, which is already enforced by AMS for markets subject to the Act,
The EEOC has described racial discrimination as discrimination based on an “immutable characteristic associated with race, such as skin color, hair texture, or certain facial features.” Although race and color may appear indistinguishable, they are not. According to the EEOC, “color discrimination occurs when a person is discriminated against based on the lightness, darkness, or other color characteristic of the person.”
ECOA defines marital status as the “existence, absence, or likelihood of a marital relationship between the parties,” and so marital discrimination would be upon those bases.
Because of the Act's broad applicability (as discussed in section III—“Authority”); the similar language used in secs. 202, 304, 305, and 312 of the Act; and the series of statutes outlining a range of prejudices identified as being deserving of public policy efforts to ensure full market access; AMS concludes that producers who have been subjected to discrimination, prejudice, disadvantage, or exclusion on the specific bases set forth in this final rule should be covered by the prohibitions against undue prejudice or disadvantage and unjust discrimination as enumerated by sec. 202 of the Act.
To stamp out unjustly discriminatory and unduly prejudicial conduct and support a more inclusive marketplace, AMS, in § 201.304, lays out the protected bases against which undue prejudices or disadvantages and unjust discrimination are prohibited, and then describes the specific conduct that, when initiated against a producer belonging to one of the protected bases, is prohibited. Paragraph (a)(1) prohibits a regulated entity from prejudicing, disadvantaging, inhibiting market access, or otherwise taking an adverse action against a covered producer on the basis of the covered producer's (i) race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, marital status, or age; or (ii) the covered producer's status as a cooperative. The sources of these bases are discussed above. Paragraph (a)(1)'s prohibition as “based upon” is intended to be broader than “but for” causation and so capture when the protected characteristics or status are a material, or non-trivial, element of the decision to take an adverse action against a covered producer. AMS expects that fact-finding tribunals will establish the necessary processes for proving these elements, with an eye toward the protections for covered producers and for open, inclusive markets that this rule is designed to provide.
Though this regulation prohibits prejudice or disadvantage against a covered producer on the basis of the specified statuses, AMS notes that regulated entities may decline to do business with covered producers for justified economic reasons. For example, a regulated entity may refuse to contract with a cooperative of covered producers when the contract would not be cost-effective for the entity, regardless of the cooperative status of the producers. In this hypothetical example, the regulated entity would not be unduly prejudicing cooperatives of covered producers based on their status as a cooperative. Instead, the regulated entity would have a nonprejudicial basis for its business decision.
Section 201.304(a)(2) describes the actions that prejudice, disadvantage, inhibit market access, or are otherwise adverse under paragraph (a)(1). These actions were chosen because they relate to fairness in contracting, which is a consistent concern among producers; and are actions that PSD has determined are a recurring problem in the industry, directly impacting producers' financial well-being. In response to the proposed rule, many commenters noted the financial repercussions of lack of fairness in contracting.
Paragraph (a)(2)(i) prohibits the offering of less favorable contract terms to covered producers on the basis of their status as members of a protected class. In the Agency's experience, offering less favorable contract terms than those generally or ordinarily offered to similarly situated covered producers is a means through which regulated entities can prejudice or disadvantage producers. For example, the Agency has received complaints that the bidding on livestock by regulated entities occurs at a less advantageous time for certain producers on the basis of the classes protected under this rule resulting in lower prices or less favorable delivery terms. Similarly, in the Agency's experience, poultry growers have complained about being offered less favorable growing terms on the basis of the classes protected under this rule. This rule does not prohibit ordinary contracting for different prices on the basis of differences in product
Paragraph (a)(2)(ii) prohibits regulated entities from refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers. This refers to situations in which a regulated entity makes no reasonable effort to deal, bid, or negotiate with a covered producer on the basis of the covered producer's status as a member of a protected class. Such refusal to deal has no connection with the service or quality of product offered, but rather is due, in material part, to the personal characteristics or status of the producer and restricts the producers' ability to obtain the fair market value of their products and services. In today's highly vertically integrated and concentrated markets, refusal to deal by one regulated entity will often leave a producer with very few, if any, parties to contract with, unduly inhibiting the competitive marketplace when performed on the bases prohibited by this final rule.
Paragraph (a)(2)(iii) prohibits regulated entities from performing under or enforcing a contract differently than with similarly situated producers. A violation of this regulation would occur when a regulated entity—based upon the covered producer's protected characteristics—inconsistently enforces its contracts as it would with similarly situated producers. For instance, a selective information disclosure would represent a selective performance of contract when a regulated entity withholds materially relevant information from one covered producer that the regulated entity generally or ordinarily provides to other covered producers. In these instances, information-deprived producers will have an incomplete picture of their business relationships with regulated entities, and therefore will operate at an unreasonable disadvantage relative to producers who receive the pertinent information. Similarly, the Agency has received complaints over the years with respect to differential performance under poultry growing arrangements, such as the delivery to affected growers of flocks that are sick or otherwise known to be likely to perform poorly owing to the age of the hens. Those sick or poor performing chicks are likely to result in lower performance for the grower in a poultry grower ranking system, which results in lower pay for the grower. While that may occur from time to time per natural cycles, a repeated or intentional delivery of underperforming flocks has been commonly reported by producers as a principal means of adversely affecting grower earnings. Similarly, a regulated entity withholding or delaying delivery of feed would result in lower performance and profit for a producer. Accordingly, AMS has incorporated differential contract performance to capture those contractual performance-based means to prejudice or disadvantage producers. By clarifying in its final rule that the Act prohibits such conduct, AMS seeks to better protect producers who suffer, or are at risk of suffering, this type of harm.
Paragraph(a)(2)(iv) prohibits a regulated entity from, on the basis of a covered producer's protected status, requiring a contract modification or renewal on terms less favorable than those for similarly situated covered producers. The Agency has determined, based on producer complaints, that regulated entities sometimes prejudice or disadvantage growers by reducing numbers of flocks delivered, changing types of birds raised, or otherwise changing contract terms that result in lower incomes for growers. Poultry producers commonly experience these types of contract modifications. Livestock producers also experience modifications, such as a change from a cash negotiated contract to a negotiated grid contract or other purchase type that may be adverse from the perspective of the producer depending on the facts and circumstances. Therefore, in the final rule, AMS seeks to clarify that unfavorable contract modification or renewal by a regulated entity, on the basis of a protected class, amounts to a violation under the Act. This rule, by itself does not prohibit renegotiations or failure to renew a contract on the basis of changes in the market. However, while this rule does not distinguish modification for other reasons, many contract terms under the Act are not subject to modification during performance of the contract
Paragraph (a)(2)(v) prohibits regulated entities from terminating or not renewing a contract with a covered producer on the basis of a covered producer's status as a protected class. Contract termination can have devastating consequences for producers that have invested substantial sums in infrastructure that only meets the requirements of a particular integrator.
Paragraph (a)(2)(vi) prohibits regulated entities from any other action that a reasonable covered producer would find materially adverse. This provision provides a broad and flexible approach to these prohibitions and allows for “material” to be determined by the facts and circumstances of each case where producers were harmed.
Finally, § 201.304(a)(3) delineates two exceptions to the prohibition on prejudicial or discriminatory conduct against covered producers on a protected basis. In one, the regulated entity is fulfilling a religious commitment relating to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry; in the other, a Federally recognized Tribe, including its wholly or majority-owned entities, corporations, or Tribal organizations, is performing Tribal governmental functions. As discussed in Section V—Changes from the Proposed Rule, these exceptions were added in response to commenters' request that some exceptions be provided to the prohibition on undue prejudice and unjust discrimination. To safeguard the free exercise of religion, AMS has provided an exception to allow discriminatory conduct necessary to fulfill religious commitments surrounding livestock care and meat production. To conform with longstanding jurisprudence surrounding Tribal sovereignty, AMS has provided an exception to allow Tribal entities to preference their own Tribal members in the purchase and sale of livestock.
Section 201.304(b) establishes protected activities for covered producers and prohibits regulated entities from engaging in retaliatory conduct based on those activities. As noted previously, sec. 202(a) of the Act prohibits unjust discrimination. This regulation is designed to protect the essential activities producers must engage in to bargain effectively and exercise their economic rights, and in doing so obtain the full value of their livestock or poultry products or services. As a result, retaliation against producers because they have engaged in protected activities is disparate treatment that the Act intended to prohibit.
AMS determined the protected activities to include in § 201.304(b)(2) based on commonly recorded complaints from the industry, case law, USDA/DOJ workshops, conversations with AMS personnel, and a recently voiced concern from Congress. AMS also identified these types of activities because of their potential to mitigate certain ways that market power is exercised. The retaliatory conduct prohibited by this regulation covers a broad range of circumstances that AMS has determined occur commonly in connection with livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry. Free exercise of the protected activities facilitates a competitive and transparent market, ensuring producers can capture the full value of their livestock or growing services.
Section 201.304(b)(1) establishes that a regulated entity may not retaliate or otherwise take an adverse action against a covered producer based upon the covered producer's participation in protected activities. As described in Section V—Changes from the Proposed Rule,” paragraph (b)(1)'s prohibition as “based upon” is intended to be broader than “but for” causation and so capture when the protected characteristics or status are a material, or non-trivial, element of the decision to take an adverse action against a covered producer. AMS expects that fact-finding tribunals will establish the necessary processes for proving these elements, with an eye toward the protections for covered producers and for open, inclusive markets that this rule is designed to provide.
Section 201.304(b)(2) lists the activities that are protected. Paragraph (b)(2) also provides a caveat that the protected activities must not otherwise be prohibited by Federal, Tribal, or State law, including antitrust laws. As outlined in the following paragraphs, these activities form an essential foundation for producers to receive the benefit of their bargained for exchange and the protections afforded under the Act itself. Acts of retaliation to chill or curtail these protected activities offer no competitive benefits to the market. Commenters to the proposed rule echoed these concerns.
Farmers and Ranchers should be able safely participate as witnesses in any proceeding relating to violations of the Packers and Stockyards Act. Unfortunately, there are recent examples of cattle rancher witnesses who were threatened and intimidated so much that they decided not to testify before Congress at a hearing about cattle markets. The ability to testify without fear of retaliation is essential to promoting fair and competitive markets in the livestock and poultry industries.”, available at
Specifically, paragraph (b)(2)(i) protects a covered producer's ability to communicate with a government entity or official or to petition a government entity or official for redress of grievances with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry. A covered producer must be able to freely seek redress of grievances to ensure the protections afforded by the Act and its regulations have their intended effect. Government regulators must also have the ability to fully appreciate the views of market participants to ensure that the rules and regulations—and enforcement of those laws and regulations—are sufficiently responsive to market realities and divergent interests and business practices in the marketplace. Hindering the free flow of market information creates risks of market distortions and will impair the ability for those with less economic power to operate in the marketplace.
In paragraph (b)(2)(ii), AMS adds a new protection for a covered producer to refuse a regulated entity's request that the producer communicate with a government entity or official when that communication is not required by law. Just as covered producers have the right to communicate with government entities or officials to ensure their rights are protected, so too do they have the right to decide when and under what circumstances they engage in such communication. Based on its experience regulating the livestock sector, AMS is aware that regulated entities may coerce covered producers to contact the government on regulatory and policy matters and to espouse positions that the covered producers disagree with. AMS has received reports frequently in the past, and including within the last two years, of regulated entities pressuring producers to oppose regulations that the producers support, and covered producers reported similar concerns to AMS during earlier rulemaking initiatives as well. Indeed, regulated entities should not punish a covered producer for the producer's decision to talk to government agencies or not, regardless of the producer's reasons.
The lack of clarity around prohibitions on retaliation in agricultural markets—clarity which this rule aims to provide—impairs AMS's ability to investigate potential violations and effectively enforce the Act. Accordingly, AMS has added § 201.304(b)(2)(ii) to clarify that the rule protects a covered producer from retaliation if the covered producer decides not to engage in a communication with a government entity or official that is not required by law.
Paragraph (b)(2)(iii) protects a covered producer asserting the right to formor join—or to refuse to form or join—aproducer or grower association or organization, or cooperative, or the right to collectively process, prepare for market, handle, or market livestock or poultry. “Asserting the right” includes the preparatory steps necessary to form or join an association or cooperative. This provision protects two forms of producer interactions: cooperative and non-cooperative associations. The formulation “to collectively process, prepare for market, handle, or market livestock or poultry” refers to forming or joining a cooperative, tracking the language of the Capper Volstead Act.
Non-cooperative associations and organizations are also core activities under the Act deserving of protection
Paragraph (b)(2)(iii) also protects a covered producer's right to refuse to join a producer or grower association or organization. AMS added protection for refusing to form or join a producer or grower association or organization in response to public comment on the proposed rule, as commenters noted that producers have experienced pressures from regulated entities to join certain organizations that may express views or interests in the livestock or poultry industry that are contrary or not fully reflective of the producer's views regarding their own interests.
Paragraph (b)(2)(iv) protects a covered producer's ability to communicate or cooperate with a person for the purposes of improving production or marketing of livestock or poultry. “A person” is intended to be broad, and includes USDA's Extension and other academic experts, businesses and associations, advisors and associates of the covered producer, other covered producers, including someone under contract with the same regulated entity. This regulation protects a covered producer's ability to communicate or cooperate with other persons, including efforts to obtain higher or otherwise more appropriate compensation from regulated entities, to the extent permissible under Federal antitrust laws and cooperative laws. Protecting such communications enables the producer to obtain help to enhance their ability to compete in the market. Such communication may include, for example, communication with extension programs or with independent veterinarians and animal health experts. It would also include communications with persons—including other producers—relating to potential illegal market abuses, anticompetitive conduct, or otherwise illegal conduct by regulated entities, as that conduct would obstruct the covered producer's ability to secure the full value of their livestock or poultry product or services. AMS notes that communications on these matters when with the government would be protected by paragraph (b)(2)(i), and would include but not be limited to communications with: USDA; the U.S. Department of Justice; the Federal Trade Commission; a State or Tribal attorney general or agriculture department; or a Federal, State, or Tribal legislative office or committee or judicial tribunal.
Paragraph (b)(2)(v) protects a covered producer's ability to communicate, negotiate, or contract with a regulated entity, another covered producer, a commercial entity, or a consultant for the purpose of exploring or entering into a business relationship. The purpose of the provision is to preserve and promote the competitive position of the covered producer and ensure that a regulated entity's retaliation does not discourage a covered producer from seeking competitive alternatives. It affords producers the opportunity to realize the full market potential of their products and services and participate in the market fully, including through price discovery and competition between multiple regulated entities. For example, a covered producer may want to seek information from a regulated entity with which they do not currently have a business relationship regarding the possibility of a future business relationship, such as entering into a contract. Or, a covered producer may enter into a contract to sell livestock in the market or through an auction or exchange. Protecting these activities allows covered producers to freely compare potential business relationships and choose between several regulated entities, encouraging competition. As also discussed in Section V—Changes from the Proposed Rule, communications of this type can improve production efficiency and price discovery mechanisms. Restricting participation in these activities forecloses full market participation by producers.
Paragraph (b)(2)(vi) protects a covered producer's ability to support or participate as a witness in any proceeding under the Act or any proceeding that relates to an alleged violation of any law by a regulated entity. Because of the close-knit and concentrated markets in which covered producers operate, AMS believes that protecting some covered producers as witnesses may enable other covered producers to effectuate their rights under the Act and related laws, which would improve market integrity in the markets governed by the Act. Without such protections, enforcement of the Act may be frustrated overall.
Finally, paragraph (b)(2)(vii) protects a covered producer's ability to assert any of the rights granted under the Act or the regulations in 9 CFR 201, or to assert rights afforded by their contract. These rights include, for example, producers' rights to view the weighing of flocks, which is legally protected but which producers have complained is not practically enforceable. In the 2010 USDA-DOJ public workshop on the poultry market, a grower said he was retaliated against for asserting his right to view his flock being weighed; the integrator “cut me off from growing business and cost me hundreds of thousands of dollars.”
Section 201.304(b)(3) enumerates the actions that are retaliation or an otherwise adverse action under paragraph (b)(1) of this section. The final rule intends to capture the widest range of conduct harmful to producers, where such harms are based upon activities protected by the rule. The focus in any inquiry under this final rule is whether the regulated entity has engaged in harmful conduct in whole or material part because a covered producer engaged in any protected activity. To provide examples of what activities are materially harmful to a reasonable covered producer, paragraph (b)(3) sets out that regulated entities are prohibited from (i) terminating or not renewing a contract with a covered producer; (ii) performing under or enforcing a contract differently than with similarly situated covered producers; (iii) requiring a contract modification or a renewal on terms less favorable than those for similarly situated covered producers; (iv) refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers; (v) interfering in farm real estate transactions or contracts with third
Paragraph (b)(3)(i) prohibits terminating or not renewing a contract with a covered producer because the covered producer has engaged in protected activities. This practice can have devastating consequences for producers that have invested substantial sums in infrastructure that only meets the requirements of a particular regulated entity. Furthermore, in concentrated markets, losing a contract may put a producer out of business as the producer has few, if any, other livestock or poultry buyers to whom they can sell livestock or poultry.
Paragraph (b)(3)(ii) prohibits performance under or enforcement of a contract differently as compared to performance under or enforcement of contracts for similarly situated covered producers as retaliation for engaging in protected activity. Depending on the facts and circumstances of the case, the “similarly situated producer” could be the covered producer's own status quo prior to engaging in the protected activity. A violation of this regulation would occur when a regulated entity, in response to a producer engaging in protected activities, inconsistently enforces its contracts compared with contract enforcement for similarly situated producers. For instance, the Agency has received complaints over the years with respect to differential performance under poultry growing arrangements, such as the delivery to affected growers of flocks that are sick or otherwise known to be likely to perform poorly owing to the age of the hens, differential delivery of feed, or other differential treatment such as early or delayed harvest of birds. Those actions are likely to result in lower performance for the grower in a poultry grower ranking system, which results in lower pay for the grower. While that may occur from time to time per natural cycles, a repeated or intentional delivery of underperforming flocks has been commonly reported as a principal means of adversely affecting grower earnings. Accordingly, AMS has incorporated differential contract performance to capture those contractual performance-based means that a regulated entity may use to retaliate against producers for engaging in protected activities.
Paragraph (b)(3)(iii) prohibits requiring a contract modification or a renewal on terms less favorable than those for similarly situated covered producers as retaliation for engaging in protected activity. Depending on the facts and circumstances of the case, the similarly situated producer could be the covered producer's own status quo prior to engaging in the protected activity. In this final rule AMS seeks to clarify that unfavorable contract modification or renewal by a regulated entity, if it's the result of a producer engaging in a protected activity, is retaliatory conduct and amounts to a violation under the Act. This behavior is a common way for regulated entities to retaliate against producers by, for example, reducing the number of flocks or their density, changing types of birds raised, or otherwise changing contract terms that result in lower incomes for growers. As another example, if a regulated entity requires a capital investment from a covered producer as part of a contract modification or contract renewal that the regulated entity is not requiring of similarly situated producers, this requirement would be a violation of paragraph (b)(3)(iii) if the regulated entity is requiring the capital investment in retaliation for the covered producer's participation in a protected activity.
Paragraph (b)(3)(iv) prohibits refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers. A violation of this regulation could occur if a regulated entity makes no reasonable effort to bid or negotiate or fails to reasonably attempt to contract in good faith with a covered producer, due in whole or material part to a producer's prior, or current, participation in protected activities. In this context, the regulated entity's refusal to deal is not connected with the service or quality of the product offered, but rather is material in part due to the producer exercising his or her rights to engage in protected activities. A similarly situated producer may, depending on the facts and circumstances, be the producer's own prior status quo with the regulated entity before the producer engaged in a protected activity. This provision includes scenarios in which cattle producers operate in the cash market for livestock. While some cattle producers may only be in the cash market a few times a year, others may be in the cash market weekly. In the latter case, this provision would cover certain types of retaliation. If a producer sells cattle to a particular packer every week, and then one week the packer refuses to buy the producer's cattle or offers significantly less favorable terms after the producer engaged in a protected activity, this would constitute retaliation under this rule absent evidence of changed business conditions necessitating the packer's refusal to deal. AMS believes that retaliating against a producer in this way is conduct the Act seeks to remedy because it raises a barrier to competitive entry to the market by decreasing the number of parties a producer can do business with, which in effect is a market failure.
Paragraph (b)(3)(v)'s prohibition on interfering with a covered producer's farm real estate transactions or with their contracts with third parties is a prohibition against conduct that a regulated entity may engage in due to the unequal power dynamic that exists between producers and the few firms available for them to contract with. This conduct may take several forms but has been observed most commonly to occur when a producer attempts to sell its farm to a third party and in doing so must terminate or fail to renew their existing contract with a regulated entity. In these situations, the regulated entity may choose not to guarantee a similar contract, or any contract at all, to the prospective buyer. Without this guarantee, banks and prospective buyers are unlikely to enter the farm real estate transaction because the land is of little use to them without a contract to grow livestock or poultry. This is often seen in the poultry sector, where it is alleged that regulated entities use the potential transfer of farm real estate as an opportunity to require growers to make capital improvements in exchange for their guarantee to contract with the new grower. This becomes retaliatory because the unreasonable refusal to guarantee a future contract with a prospective landowner or operator dramatically lowers the value of the farm operation, to the point of obstructing the transfer of the real property by the landowner, and yet the debt burden on the farm is commonly incurred in response to the regulated entity's requests for additional capital investments. The seller of farm real estate faces an unjust extraction, or else they are unable to sell land, as the cost of capital improvements required by the regulated entity in exchange for a guarantee to contract with a new owner or operator is not a freely-determined agreement. Farm sales transactions are not, however, the only circumstance where a regulated entity can retaliate against a covered producer through contracts with third parties. For example, covered producers have sought to develop new marketing opportunities for their livestock and poultry through collectively processing their product. If the regulated entity sought to obstruct the sale of the meat or poultry products through distribution or retail chains as retaliation against a
Paragraph (b)(3)(vi) prohibits any other action that a reasonable covered producer would find materially adverse. This regulation is designed to account for a broader scope of actions that are considered retaliatory. Under this provision any conduct would be considered prohibited retaliation if such conduct caused material harm to the covered producer relative to the covered producer's situation prior to the allegedly retaliatory conduct, or relative to conduct toward similarly situated producers. This provision provides a broad and flexible approach to these prohibitions and allows for “material” to be determined by the facts and circumstances of each case. As discussed under Section V—Changes from the Proposed Rule, some retaliatory activities may occur outside the confines of contractual relationship, for example, a regulated entity's interference in a covered producers' water rights. The provision also covers the act of making a threat to engage in an action where the threat can reasonably be foreseen to change the producer's conduct or where the threat delivers a reasonable possibility of material harm.
When regulated entities punish covered producers or deny them opportunities afforded to other covered producers for engaging in certain activities, it is an unjustly discriminatory practice. Not only do retaliatory practices harm individual covered producers; recurrent instances and patterns of retaliation erode market integrity and discourage fairness and competition in the livestock and poultry markets. Under § 201.304(b), AMS is providing greater clarity, specificity, and certainty as to how the Act applies with respect to retaliatory behavior. This will facilitate higher levels of compliance by regulated entities, enable AMS to better enforce the Act, and position producers to better assert their rights under the Act.
Paragraph (c)(1) of § 201.304 requires that a regulated entity retain all records relevant to its compliance with the prohibitions on discriminatory behavior contained in paragraphs (a) and (b) of this section. Records must be retained for no less than five years from the date of record creation. Paragraph (c)(2) states that relevant records may include policies and procedures, staff training materials, materials informing covered producers regarding reporting mechanisms and protections, compliance testing, board of directors' oversight materials, and the number and nature of complaints received relevant to this section.
Recordkeeping is a commonly used regulatory compliance and monitoring mechanism among market regulators.
Existing gaps in both generally applicable agricultural and PSD-specific data collection make addressing widespread reports of discriminatory behavior difficult. Access to the types of records required by § 201.304(c) will assist AMS in assessing the effectiveness of a regulated entity's compliance with § 201.304(a) and (b). Therefore, this recordkeeping requirement is critical for AMS to fulfill its duties to prevent, and if necessary secure enforcement against, undue and unreasonable prejudice and unjust discrimination.
AMS believes that this recordkeeping approach—at both the regulated entity policy and procedural level, as well as at the transactional level—will enable the Agency to monitor and facilitate a regulated entity's approach to compliance. Recordkeeping will encourage regulated entities to adopt more robust compliance practices to stamp out conduct prohibited by the Act in its incipiency. It will also enable AMS to uncover conduct that violates the rule in any investigation—a deterrent which will also strengthen compliance. AMS underscores that the tone and compliance practices set by senior executives play a vital role in establishing a corporate culture of compliance, which is a critical first step toward more inclusive market practices. Thus, relevant records may include those at the highest levels, such as relevant accountability practices of the board of directors. In addition to the importance of policies and procedures in developing a corporate culture of compliance, this rule maintains that transactional records, where decision-making occurs, are also important records to keep and to help AMS understand why an adverse action was taken against a producer or grower by a regulated entity. These records may include the number and nature of complaints received relevant to this section; in addition to records already required to be retained under § 203.4, such as buyers' estimates; buying or selling pricing instructions and price lists; correspondence; telegrams; or teletype communications and memoranda relating to matters other than contracts, agreements, purchase or sales invoices, or claims or credit memoranda.
AMS is requiring that records be retained for five years from their creation date to provide a broader ability to monitor the evolution of compliance practices over time in this area, and to ensure that records are available for what may be complex evidentiary cases. While providing the authority for regulated entities to keep certain records, sec. 401 of the Act does not provide guidance on when records can be disposed. Existing regulation at 9 CFR 203.4 provides for a disposal date of two years, with an exception for certain records that may be disposed of after one year. This rule extends the disposal date of most records from two years to five years to promote efficient USDA monitoring efforts. For some records, the current disposal date is one year, which could be extended to five years under this rule if they are deemed relevant to showing compliance with this rule. Most records, such as specified in sec. 401, “such accounts, records, and memoranda as fully and
Section 201.306 is designed to broadly address deceptive practices in the marketplace by establishing four categories where deceptive practices commonly occur: contract formation, contract performance, contract termination, and contract refusal. Overall, the final rule addresses areas of concern regarding deception in contracting but does not exhaustively identify all deceptive practices that violate sec. 202(a) of the Act. Through this rule AMS aims to promote a marketplace that is free from the type of injury the Act was designed to prevent. False or misleading statements, or omissions of material information, during the contracting process or operation or termination of that contract, are prohibited deceptive practices because they prevent or mislead sellers or buyers from making informed decisions concerning their livestock or poultry operations. Deception puts honest businesses at a competitive disadvantage; and may even cause them to adopt deceptive practices.
More than 100 years of history illustrate the types of conduct prohibited as deceptive by the Act, which provides a foundation for some of the specific deceptions that this rulemaking addresses. The regulations implemented by this rulemaking are not the first to prohibit deception. Current regulations under the Act require honesty in weighing (9 CFR 201.49 and 201.71), price reporting (§ 201.53), fees (§ 201.98), and business relationships (§ 201.67). Even when considering whether termination of a contract violated the Act, AMS currently considers the quality of the communication, and therefore considers its honesty (see § 201.217). Past cases indicate that USDA's approach, generally, is to view representations, omissions, and practices from the perspective of a reasonable party receiving them and determine if those deceptions affect the conduct or decision of the recipient. As the court explained in
AMS aims to have regulated entities be truthful and straightforward—that is, not misleading—in their dealings with producers. With § 201.306, AMS seeks to uncover the true motive for a regulated entity's treatment of a producer with whom they are forming or have a contractual relationship. Whether contract language was clear and written in a language the producer understands will be part of any evaluation to determine whether a statement (including any omission) was false or misleading; that determination will be dependent on the particular facts and circumstances of the contract. Violations of the Act that would constitute deceptive practices include false statements or omissions that are material in that they prevent sellers or buyers from making an informed business decision.
Producers should not be misled with respect to their business decision-making with regulated entities. Deception can prevent producers from obtaining the full value of their products and services. In markets pervaded by deception, formerly honest businesses may be compelled to adopt deceptive practices if they are to remain competitive.
Paragraph (a) of this section sets forth the scope of the prohibition on deceptive practices by establishing that the prohibitions contained in paragraphs (b) through (e) of § 201.306 apply to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry. This phrasing, which has been used in previous rules under the Act, points to the broadest possible interpretation of the Act's jurisdiction over regulated entities' conduct.
Section 201.306(b) prohibits a regulated entity from making or modifying a contract with a covered producer by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading. Preventing false or misleading representations, express or implied, or failing to provide the necessary information necessary to make a representation not misleading during the contracting process, are some of the most basic protections of the integrity of the marketplace. “By employing” captures the materiality of the false or misleading representation in that the representation formed a material part of the action under making or modifying the contract. Case law applying the Act illustrates some of the forms of deception that regulated entities may take during the offering or formation of a contract with producers. While some consumer-focused cases under the Act have addressed false advertising—specifically bait-and-switch advertising that occurs through advertising on price when, in fact, the customer has to pay a higher price at the point of sale,
Deception in contract formation is not limited to false statements and omissions with respect to regulatory requirements. The Act includes affirmative duties to be truthful. For instance, in
Section 201.306(c) prohibits a regulated entity from performing under or enforcing a contract with a covered producer by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading. It is fundamental to the integrity of the marketplace and critical during the performance or enforcement of contracts that regulated entities are prohibited from making false or misleading representations—express or implied—and that they are prohibited from failing to provide the necessary fact or information necessary to make a representation not misleading. “By employing” captures the materiality of the false or misleading representation in that the representation formed a material part of the action under performing or enforcing the contract.
Deceptive practices take many forms throughout the operation of a contract. USDA and the courts have recognized these forms in a variety of administrative and Federal enforcement actions, including false weighing, false or deceptive grading (including failure to disclose the formulas for determining payment), failure to pay for purchases, and pretextual refusals to deal.
False or inaccurate weighing has long been recognized as deceptive under secs. 202(a) and 312 of the Act.
False or inaccurate grading has the same effect as false weighing because deceptive grading prevents the seller from receiving the full value of their livestock or poultry. A USDA Judicial Officer found a deceptive practice when a packer failed to inform hog producers of a change in the formula it used to estimate lean percent in hogs. Lean percent was one factor used in determining price when the packer purchased hogs on a carcass merit basis. USDA determined that nearly twenty thousand lots of hogs were purchased under the changed formula without notice to producers, resulting in payment of $1.8 million less than they would have received under the previous formula.
Payment violations can also be deceptive, especially issuance of
Section 201.306(d) prohibits a regulated entity from terminating a contract with a covered producer by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading. Employing false or misleading representations, express or implied, or failing to provide the necessary fact or information necessary to make a representation not misleading—critical protections during the performance or enforcement of contracts—are similarly fundamental to the integrity of the marketplace. “By employing” captures the materiality of the false or misleading representation in that the representation formed a material part of the action under performing or enforcing the contract. AMS draws on its experience in establishing the need for this prohibition. AMS notes, for example, that poultry growers complain of companies terminating their broiler production contracts based on pretext or for a deceptive reason. Contract termination puts the grower at severe risk of significant economic loss. The potential loss includes not only the loss of production income but also a grower's farm or family home, since a production broiler house construction is often financed with mortgages on those assets. Pretextual cancellation, in the form of false or misleading representations or material omissions, may also make even the sale or transfer of the broiler production house impossible because purchasers may be unable to determine if the broiler houses have value.
AMS included the prohibition against false or misleading information or material omissions in paragraphs (b) through (d) to protect producers from conduct that employs deceit to disguise a regulated entity's genuine motive. A poultry producer stated in a public workshop that he relied upon cash flow statements provided by the integrator to secure a loan for his operation only to find out later “that the document wasn't accurate from the first flock that I placed and set. The capital investment of these facilities, while they may be greatly benefiting the integrator, are not returning any value to us whatsoever.”
Section 201.306(e) prohibits a regulated entity from providing false information to a covered producer or association of covered producers concerning a refusal to contract. Deception related to refusal to contract is an unlawful practice designed to exclude producers from livestock and poultry markets. For example, if a producer association is asking on behalf of its members why a regulated entity is not executing any deals in the cash market and the entity lies about why it is avoiding the cash market, this could impede market entry for the association's members. Owing to the risk of retaliation, even with this final rule in place, a covered producer may depend upon a producer association to obtain the necessary understanding why the regulated entity is engaging in certain practices in the market, such as refusing to contract with covered producers.
A regulated entity that refuses to contract on unlawful grounds may well choose to hide their motives with misleading or deceptive statements. This regulation recognizes false and misleading statements made as justification of a refusal to enter into a contract as “deceptive” within the meaning of the Act. However, when refusing to enter into a contract, a regulated entity is not required to explain its reasoning so long as it does not offer a false or misleading statement to a covered producer.
Producers and consumers cannot make rational decisions in a dishonest market, and honest competitors cannot compete when regulated entities deceive. With this rulemaking, AMS is adding § 201.306 to its existing deception regulations under the Act to provide a broad array of coverage regarding the general circumstances that encourage the provision of false or misleading information in contracting. This regulation does not provide an exhaustive list of instances of deceptive practices; rather, it establishes four categories where deceptive practices commonly occur. The intent is to provide guidance to covered producers on how to effectuate their rights under section 202(a) of the Act and to promote a marketplace that is free from the type of injury section 202(a) was designed to prevent. AMS will investigate any alleged violations of this regulation and its determination will depend on the facts and circumstances of each case.
AMS is adding § 201.390, “Severability,” to new subpart O to confirm that if any provision of subpart O, or any component of any provision, is declared invalid or if the applicability thereof to any person or circumstances is held invalid, it is AMS's intention that the validity of the remainder of this subpart or the applicability thereof to other persons or circumstances shall not be affected thereby with the remaining provision, or component of any provision, to continue in effect. Such a provision is typical in AMS regulations that cover several different topics and is included here as a matter of housekeeping.
This rule aims to address concerns around unduly prejudicial, unjustly discriminatory, retaliatory, and deceptive conduct in the livestock and
AMS intends that the severability provision operate to the fullest extent possible. AMS recognizes that—to a limited extent—not all the language of the rule is severable. For example, to find undue prejudicial discrimination under “race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, or marital status, or age of the covered producer,” the prejudicial conduct must be “on the basis of” one of the specified protected bases. AMS recognizes that this causation requirement is not severable as it is integral to that specific provision of the rule.
However, AMS intends that all other portions and components of the rule may be severable without affecting the remaining portions of the rule, and that the rule remains workable and continues to serve the interests of the agency's policy goals. For instance, AMS intends that the invalidity or unenforceability of one of the rule's prohibited bases does not render the others invalid or unenforceable. The protected bases have different reasons for their appearance in the rule. For example, if the protected base of religion were found invalid or unenforceable, this does not negate the benefits of including protections for another protected base, like sex. Also, to further follow this example, the language in § 201.304(a)(1)(i) is severable from those included in the retaliation (§ 201.304(b)) and deception (§ 201.306) sections. Therefore, one or more provisions might be unenforceable as to an individual or a specific case, but AMS intends that the remaining provisions would still be enforced. Finally, if determining the necessity of an individual provision to the enforceability of its entire section, and the benefits of that section are still intact without an unenforceable provision, AMS would intend to retain the enforceable provisions.
AMS received 446 public submissions in response to the proposed rule. Numerous comments to the proposed rule expressed concerns that concentrated, vertically integrated markets expose producers to exclusion from the market on bases unrelated to the quality of their products or services and that the markets in which the commenters operate lack sufficient honesty, integrity, and fair dealing. In addition, numerous comments stated that, except for very narrow justified circumstances, there are no competitive benefits to these practices when operating within a market where producers are less able to compare, negotiate, or change business relationships.
Other commenters were critical of the proposed rule. Some commenters expressed disagreement with the need for the proposed rule, arguing that it is duplicative of the Act and existing regulations, while other commenters stated that the proposed rule's vagueness would make compliance a challenge. Other commenters argued that the proposed rule would result in costly litigation and recordkeeping burdens and exceeded AMS's authority under the Act.
The public comments are summarized by topic below and include AMS's responses.
AMS proposed to add definitions in § 201.302 for
In § 201.302, AMS proposed to define
Similarly, a meat industry trade association said AMS should withdraw or amend the definition of
AMS proposed in §§ 201.304 and 201.306 to apply its prohibitions on undue prejudice, retaliation, and deceptive practices to swine contractors and live poultry dealers as defined in sec. 2(a) of the Act and to packers as defined in sec. 201 of the Act. Proposed § 201.304(a)(1) would prohibit prejudice, disadvantage, or the denial or reduction of market access by regulated entities against covered producers based on their status as “market vulnerable” producers. AMS requested comment on whether the prejudicial discrimination and retaliation provisions should be extended to all persons buying or selling meat and meat food products, including poultry, in markets subject to the Act.
An agricultural advocacy organization said that if AMS adds aspects of regional concentration and aspects of contract growing arrangements, such as high debt load, to the definition of a market vulnerable individual, then the proposal to provide protection based on market vulnerable individual status is appropriate. This commenter noted that AMS's question regarding extension of the prejudicial discrimination and retaliation provisions highlights the need for a separate rule addressing enforcement of the Act's prohibition on undue preferences. According to this commenter, if AMS makes it clear that it intends to enforce the Act to stop companies from giving undue preferences to some sellers, everyone participating in these markets will have adequate protection.
AMS underscores that the protections for cooperatives are intended, in part, to help producers gain market leverage in the face of concentrated markets. In 1922 Congress passed the Capper-Volstead Act providing legal protections for producers to collectively process, prepare for market, handle and market their products. Cooperatives enable smaller, disparate producers to band together, coordinate in ways that otherwise may not be permissible under the antitrust laws outside of a single company, and otherwise work together to obtain a better bargain from market counterparties with larger economic footprints. AMS will continue to work toward addressing problems associated with concentration through subsequent rulemaking. USDA is also utilizing other tools to address undesirable business practices born from market concentration that adversely impacts producers. USDA is investing $1 billion to support greater choice for producers through expanded local and regional processing capacity in meat and poultry. USDA has also announced enhancements to its antitrust enforcement partnerships, including investing in partnerships with DOJ through farmerfairness.gov and with more than 32 State attorneys general, updates to its meat and poultry labels that will better guard against misbranding that damages the signals that flow from consumers to producers, as well as other agency actions intended to address unfavorable behavior by regulated entities facilitated by concentration in the livestock industry.
However, addressing unjust discrimination solely on the basis of the size or indebtedness of the producer is outside the scope of this rule, and because of the complex economic implications of volume preferences and efficiencies, would be more appropriately considered in the context of a future update to undue preferences rules. In contrast, undue and unreasonable prejudice or disadvantage on the basis of the prohibited bases and protected activities adversely affects allocative efficiency and offers no competitive benefits. That is true irrespective of whether the unlawful conduct occurs in a concentrated market or not.
AMS has shifted away from its market vulnerable approach and has adopted a well-established standard in line with existing economic, civil rights, and other regulatory regimes that rely on protected bases for discrimination. Producers with high debt loads are not included in those well-established protections; therefore, AMS will not include them in its final rule.
AMS proposed new provisions in § 201.304(a) that would prohibit regulated entities from prejudicing, disadvantaging, or inhibiting market access, or otherwise taking adverse action against a livestock producer, swine production contract grower, or poultry grower based on the producer's status as a “market vulnerable individual” or as a cooperative.
AMS proposed to prohibit prejudicing, disadvantaging, inhibiting market access, or otherwise taking adverse action against covered producers based on their status as a
AMS requested comment on whether the regulatory protections provided by the prohibition on undue prejudices for market vulnerable individuals and cooperatives would assist those producers in overcoming barriers to reasonable treatment, or otherwise address prejudices or threats of prejudice in the marketplace. It further requested comment on whether specific
Several commenters stated they preferred the market vulnerable producer approach to fighting discrimination over the traditional protected classes approach because it would allow for flexibility to address different markets and different forms of prejudice and discrimination that may develop. An agricultural and environmental organization stated the market vulnerable producer approach not only covers instances of discrimination based on protected characteristics such as race, national origin, sex, religion, gender identity, and disability, but can also apply to other forms of discrimination unique to livestock and poultry markets. This commenter said this approach is consistent with the Act, which prohibits “any” unjust discrimination, and “any” undue prejudice or disadvantage “in any respect whatsoever.” Several State attorneys general suggested that the proposed definition was preferable as proposed, without specifying traditional protected classes, because it would allow for flexibility among different markets and forms of prejudice or discrimination that may develop over time.
Several agricultural advocacy organizations said poultry and cattle producers operating in regions with monopsony or oligopsony conditions should qualify as market-vulnerable individuals. Similarly, an academic or research institution sought to add producers operating in monopsony conditions to the definition. A commenter suggested AMS use the regional Herfindahl-Hirschman index to indicate the market vulnerable status of producers in a region. Some commenters cited heightened risk of adverse treatment as a rationale for considering these groups to be market vulnerable or noted that monopsony power has been legally relevant in cases under the Act and there is judicial precedent for acknowledging monopsonist power as a factor in adverse impacts to competition, while others said these groups meet the criteria laid out by AMS in the preamble to the proposed rule explaining why historically marginalized groups are likely to be vulnerable to market abuses.
Several commenters seeking protections for producers that are at increased risk of being disadvantaged due to highly concentrated regional markets cited Colorado cattle producers as an example, given the USDA has not publicly reported the State's fed cattle prices for several years because there are too few packers purchasing fed cattle in Colorado to overcome USDA confidentiality guidelines. Commenters noted, with few packers in the region, sellers in the region are vulnerable to unfair practices.
An agricultural advocacy association recommended that AMS expand the MVI definition to include covered producers whose geographic locations restrict their ability or willingness to sell and transport their livestock to two or fewer regulated entities. This commenter also said that it would be helpful for AMS to expand on and provide more “definite form” to the four socioeconomic factors presented in the rulemaking notice. The association reasoned that if producers can proactively demonstrate their status as market vulnerable, it would avoid the need for ad hoc microeconomic analyses or expert witnesses to make assessments on individual bases.
Several State attorneys general suggested AMS specifically address the vulnerability that small, rural farmers encounter due to their location or production size. The commenters stated small, rural farmers do not have enough local processors, and those processors give preference to packer-owned and contract livestock for the limited packing plant capacity available. An agricultural advocacy organization also said small, independent cattle producers meet many of the criteria for being considered market vulnerable, arguing for example that they are exposed to concentrated market forces because they do not receive forward contracting arrangements from packers; they are denied favorable bonus, financing, and risk sharing terms common with other arrangements; and they are required to sell their cattle to packers on at-will cash markets for lower aggregate compensation. Agricultural advocacy organizations also said independent cattle producers operating in cash-negotiated spot markets should be considered vulnerable because of their independent status. Other commenters recommended AMS expand market vulnerable individual status to include non-English speakers, people with limited education, producers in markets with limited buyers, and immigrant farmers.
Agricultural advocacy organizations recommended the definition of market vulnerable individual explicitly include, but not be limited to, race, color, national origin, religion, sex, sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or gender identity. Commenters asserted individuals in each of these groups should not have to continually prove discrimination and prejudice against them based on the characteristic that makes them vulnerable in the market.
Agricultural advocacy organizations expressed support for including cooperatives in the prohibited bases under proposed § 201.304. These commenters recommended that AMS explain in the preamble to the final rule the relationship between the producer association protections under the Agricultural Fair Practices Act and the proposed new protections under the Act, noting regulated entities have unjustly discriminated against covered producers based on their membership in these cooperatives due to the increased market leverage these cooperatives or other producer associations provide.
An individual commenter urged AMS to explicitly prohibit discrimination based on sexual orientation and gender identity for those who voluntarily disclose such status. The commenter
Some agricultural and environmental advocacy organizations expressed support for AMS's flexible “market vulnerable individual” approach, but also expressed concern that the proposed rule would impose a difficult burden of proof on covered producers, requiring, for example, a producer alleging discrimination based on their status as a member of a historically marginalized group (
Similarly, agricultural advocacy groups recommended that AMS clearly identify the types of individuals the agency would consider to be market vulnerable, and the methodology AMS will use to make this determination. A commenter specified producers who derive a substantial percentage of their income from their livestock or poultry operation are more vulnerable to unjust practices than those who derive a small percentage of their income from those operations. A commenter suggested that AMS develop a method to assess regional concentration levels using information regarding market share, Herfindahl-Hirschman index, and price reporting systems to allow producers to show they operate in a region that qualifies them as market vulnerable individuals.
An organization urged AMS to revise proposed § 201.304(a)(1) to clarify that the rule bans discriminatory conduct based on disparate treatment or disparate impact, not just discriminatory intent. According to the commenter, while secs. 202(a) and (b) of the Act clearly establish that the determinative factor for whether conduct constitutes a violation is its purpose or effects, the proposed language in § 201.304(a)(1) potentially requires a covered producer to prove discriminatory intent. The commenter said that, by describing prohibited conduct using the verb forms of “prejudice,” “disadvantage,” “inhibit market access,” and “take adverse action,” this language suggests the proposed rule would only prohibit actions motivated by a prohibited basis. Therefore, the commenter recommended that AMS revise this section to use language that parallels the text of sects. 202(a) and (b) in clearly distinguishing the actions of regulated entities from their discriminatory nature or effects.
Some commenters who supported AMS's market vulnerable producer approach expressed concern that the proposed rule could place a heavy burden on producers to establish an intentional discrimination claim based on market vulnerable status, citing the DOJ, among others, in noting that successfully showing discriminatory intent can be extremely difficult.
A commenter also asked AMS to establish a separate liability standard and burden-shifting framework for discriminatory-effects claims. The commenter said AMS should introduce a framework analogous to the Department of Housing and Urban Development's (HUD) Discriminatory Effects Standard,
A plant worker offered three factors to consider when determining market-vulnerable groups. These factors included being a member of any “socially disadvantaged group” as defined by the USDA Farm Bill,
Some commenters expressed opposition to the proposed definition of market vulnerable individual on the basis that it was too vague. An association asserted the definition is “so vague that neither party may be able to figure out whether the contract grower is indeed a `market vulnerable individual.' ” Commenters said the proposed definition implicates the Due Process Clause, with commenters saying the definition as drafted is so open-
Two cattle industry trade associations and a live poultry dealer contended that the ambiguity of the definition would create uncertainty for regulated entities when making market vulnerable-status determinations on a case-by-case basis, which could disincentivize bringing on new producers in the future. They argued that AMS could avoid this uncertainty if it introduced codified standards based on consistent immutable traits, such as protected classes.
Some commenters were opposed to explicitly including protected classes in the definition. A meat industry trade association noted that it can be difficult or impossible for regulated entities to ascertain all the demographic information for every producer they do business with to determine whether the producer they are contracting with is in a protected class and thus a market vulnerable individual. An agricultural association noted that regulated entities soliciting such demographic information could in and of itself give the appearance of discriminatory behavior.
Lastly, some commenters opposed the
AMS adopted several suggestions by commenters regarding the specific bases for protection against unjust discrimination. Principally, AMS's authority to clarify the protected bases stems from sec. 407 of the Act, which authorizes the Secretary to “make such rules, regulations and prescribed orders as may be necessary to carry out the provisions of this Act.”
The use of those terms comes with well-established jurisprudence in other contexts, such as ECOA, which incorporates the Act's enforcement provisions, appropriately applied in the context of livestock and poultry markets. Additionally, the status of covered producer as a cooperative was added to the list of protected classes against which discrimination is prohibited. The prohibition on discrimination covers cooperatives consistent with and in furtherance of the Agricultural Fair Practices Act. Cooperatives enable smaller producers' ability to balance concentrated economic power through their ability to coordinate and negotiate.
AMS will not include degrees of market concentration within particular geographic locations in its list of protected bases. Doing so would give rise to difficult questions around whether the government should restrict the ability of regulated entities to seek efficiency based on production volume, which is outside of the scope of this rule.
Additionally, AMS will not include in its list of protected bases a size component for the same reasons that it is not incorporating market concentration or geographic location. Nor is AMS including a prohibition against discrimination in markets with limited buyers. In both cases, such a prohibition would likely result in an all-encompassing rule that would swallow this rule's intent to protect specific well-established classes and activities which are widely utilized across multiple
In this rule, AMS does not address questions of discrimination based on the type of contract a producer has with a regulated entity for the sale of their livestock. Considerations raised in that type of discrimination, revolving around how livestock is marketed, are different from the considerations undertaken in this rule around whether the producer's personal characteristics are a prohibited basis of unjust discrimination. Nonetheless, AMS is aware that some producers may be under pressure to enter forward contacts or AMAs and that this may limit their access to markets. AMS is considering other rules that may be more appropriate for addressing those concerns.
Additionally, AMS intends for non-English-speaking producers and immigrant producers to be covered under the prohibition on discrimination on the basis of national origin or, in some cases, race if they are facing discrimination on those bases. Therefore, AMS need not expressly include non-English speaking producers in this rule. However, people with limited education are not included as protected bases because enforcement of such discrimination offers certain practical challenges and is not well defined in other areas of law.
In this final rule, AMS has expressly prohibited discrimination based on sexual orientation by adding that term as well as gender identity to the prohibited basis of sex. The Supreme Court in
Nor is disclosure a requirement for discrimination based on sex. If a regulated entity takes adverse action that amounts to undue prejudice against a person on the basis of sex, it is immaterial whether the decision is based on an accurate or inaccurate assessment of the actual gender or sexual orientation of the covered producer. In either instance, this prejudice is undue under the regulation.
In terms of concerns raised by commenters about the burden to establish a claim, producers will not have to prove their status as a market vulnerable individual as originally proposed as the bases of discrimination are now based on discrete types of protected classes. Therefore, as suggested by commenters responding to the proposed rule, AMS does not need to provide a non-exhaustive list of factors for covered producers to demonstrate their market vulnerable status.
Furthermore, because market vulnerability is no longer a consideration when assessing violative conduct, AMS is not using market vulnerability as a basis for assessing whether unjust discrimination has occurred in violation of the Act. As noted above, this final rule will not address discrimination on the basis of geographical location, regional concentration, or size of a producer's operation because this rule is focused on prohibiting adverse actions on bases for which there are no pro-competitive benefits. Differences in treatment based on geographic location, regional concentration, or size of the producer's operation all raise more challenging tradeoffs with respect to competitive benefits. To the extent that a covered producer suffers discrimination on those bases, AMS encourages the covered producer to report the concern to PSD, including through the tips and complaints portal
AMS is not establishing a formal burden-shifting framework in this rule, nor one specifically focused on discriminatory effects such as an analysis of disparate impact. Rather, AMS will leave the development of evidentiary proof to the facts and circumstances of specific cases and to the tribunals' processes and burdens for producing evidence. AMS has investigatory and enforcement capabilities to determine whether violative conduct has occurred under the Act. AMS's investigative powers are extensive and include the ability to examine regulated entities' records and compel testimony. AMS may investigate to determine whether a regulated entity's disparate treatment of a producer was on the basis of a protected class as specified in this regulation.
Moreover, as described in Section V—Changes from the Proposed Rule, subsection D—Retaliation Provisions, AMS changed “because of” to “based upon.” Paragraph (b)(1)'s prohibition as “based upon” is intended to be broader than “but for” causation and so capture when the protected characteristics or status are a material, or non-trivial, element of the decision to take an adverse action against a covered producer. AMS expects that fact-finding tribunals will establish the necessary processes for proving these elements, with an eye toward the protections for covered producers and for open, inclusive markets that this rule is designed to provide. AMS underscores that discriminatory intent is not an element of this final rule and need not be shown to establish a violation, for example, where the regulated entity cannot proffer a non-discriminatory business reason that fully justifies the adverse action, or where the producer can show that such reason offered was pretextual, a sham, or otherwise does not negate the presence of the prohibited bases as a material element of the action.
An industry association asserted establishing antidiscrimination law under the proposed rule is unnecessary because civil rights laws already are well-established. The commenter also contended the proposed rule would not address the market inequities faced by producers not included in the protected classes, and the vague proposed definition of market vulnerable individual would likely result in litigation creating additional hardship for the individuals the rule seeks to protect.
An individual indicated the proposed rule would not be effective in addressing prejudices or threats of prejudice in the marketplace and instead recommended AMS take action to create more packers, which would facilitate greater market access.
The 2020 Rule established four criteria the Secretary will consider when determining whether conduct by packers, swine contractors or live poultry dealers represents an undue or unreasonable preference or advantage. Those criteria include whether the preference or advantage cannot be justified on the basis of a cost savings related to dealing with different producers, sellers, or growers; cannot be justified on the basis of meeting a competitor's prices; cannot be justified on the basis of meeting other terms offered by a competitor; and cannot be justified as a reasonable business decision. However, as set forth in the rule itself, the criteria are not exhaustive and not determinative. The rule offers limited guidance regarding how it is to be applied.
The 2020 Rule did not include the prohibited bases of discrimination set forth in this rule because it asserted that they were undue prejudices, rather than undue preferences, which are distinct prohibitions in the statutory text.
AMS is not aware of a separate Federal law or rule that would cover the circumstances outlined in this final rule. This rule sets forth how certain adverse actions by regulated entities give rise to unjust discrimination and prejudice that, on their face, are unjust and undue and undermine a competitive market. This rule addresses the unique and often difficult-to-prove discriminatory conduct that has long existed in the agricultural sector by prohibiting specific bases of prejudicial action. In doing so, AMS is clarifying the application of the Act, better empowering producers to protect themselves, and encouraging companies to adopt more robust compliance practices to snuff out prohibited conduct prohibited by the Act in its incipiency, before, in the aggregate, it can distort markets. In particular, this rule addresses the longstanding and often difficult-to-counter forms of exclusion that have plagued the agricultural sector for decades. AMS intends for this rule to support positive trends toward inclusivity in the marketplace. As noted above, all commenters, including industry commenters, affirmed that prejudices on the basis of race, color, religion, national origin, sex, age, disability, and similar bases have no place in today's modern agricultural markets.
Demographic information is seldom recorded in agricultural transactions; therefore, it is difficult to quantify discrimination, unlike in other sectors such as housing and banking. Furthermore, in highly concentrated agricultural markets with few minority participants, further defining the Act to include a list of prohibited bases of unjust discrimination helps ensure fair competition for all farmers. This rule will help all producers better understand their rights under the law and come forward when they recognize instances of unjust discrimination. This rule will help USDA to better enforce the Act. In addition, as AMS has determined not to use the market vulnerable individual approach in the final rule, commenter concerns that the definition for market vulnerable individual will lead to litigation are moot.
AMS acknowledges one commenter's recommendation that AMS take action to reduce concentration in the meatpacking industry and create more packers, with the goal of facilitating greater market access for livestock and poultry operations. This recommendation was made out of skepticism that the rule would change
AMS asked about specific challenges or burdens regulated entities may face in complying with the undue prejudice provisions of the proposed rule. It also requested comment on how the undue prejudices provisions differ from existing policies, procedures, and practices of regulated entities.
The scope of prohibited conduct regarding adverse actions is clarified by the shift from market vulnerable individual to membership in a protected class as the prohibited bases of unjust discrimination; the focus of the inquiry should be on those bases. If a regulated entity offers a covered producer less favorable contract terms principally or substantially because the covered producer belonged to one of the protected classes, it violates the law and this rule.
AMS requested comment on whether the provisions on undue prejudice adequately address concerns regarding inequitable market access for Tribal members and Tribes. It also requested comment on how it should handle Tribal government entities that sponsor or manage regulated entities. AMS asked whether it should permit compliance with proposed § 201.304(a) to be substituted for compliance with Tribal government rules, policies, or guidance governing equitable market access.
AMS requested comment related to private industry programs aimed at establishing preferences intended to address systemic inequality by partnering with Black producers or similar programs designed to address socially inclusive supply chains. It asked whether, if such programs were present in livestock and poultry markets, it should evaluate them and determine them to be undue preferences pursuant to the criteria in 9 CFR 201.211. It also requested suggestions on ways to address relevant concerns.
AMS requested comment on whether the proposed regulation would provide appropriate protection for cooperatives, particularly with respect to the fact that their structure and organization varies across livestock and poultry markets.
Adverse treatment at the hands of a regulated entity based on a grower exercising their right to join such an organization, including a cooperative or an association, is the exact conduct this provision addresses. However, the prohibition of regulated entities prejudicing a cooperative focuses on the cooperative's market interactions with the regulated entity compared to entities that are not cooperatives, and not on the formation or association of the cooperative itself.
Collectively, members of cooperatives are better able to gain access to markets, leverage negotiating power when dealing with regulated entities, and meet volume demands based on their ability to pool outputs. The rule supports covered producers in using procompetitive cooperatives to their fullest extent. This rule aims to ensure equal treatment of covered producers by regulated entities, regardless of whether or not a grower has exercised its right to join a grower organization or association. For these reasons, AMS has not changed § 201.304(a) to include “or other association of producers.”
AMS notes that many producer associations are designed to give their members certain benefits, including some ability to negotiate with regulated entities around certain outcomes in the market. However, cooperatives are the only group of agricultural producers with explicit ability to cooperate and contract collectively with regulated entities, which includes Federal antitrust law exemptions not enjoyed by other types of associations. Nonetheless, AMS notes the importance of covered producers forming associations that may offer benefits to their members outside of collective contracting. To that end, the final rule in § 201.304(b)(2)(iii) provides important new protections against retaliation for forming or joining an association.
AMS proposed a non-exhaustive list of prejudicial actions that the regulation would prohibit, including offering less favorable contract terms, refusing to deal, differential contract enforcement, and contract termination or non-renewal.
AMS requested comment on the appropriateness of the specific prejudicial acts in proposed § 201.304(a)(2), as well as whether it should include any other forms of prejudicial conduct.
AMS requested comment on whether offering contract terms less favorable than those generally or ordinarily offered should be considered a specific prejudicial or disadvantageous action against covered producers.
AMS recognizes the existence of information asymmetry between regulated entities and covered producers, including in relation to what contract terms are commonly offered or not. AMS notes the availability of other tools to address that challenge, including new initiatives such as AMS's Cattle Contract Library Pilot, which provides disclosure into contract terms offered by packers with greater than 5 percent of the national market share, including disclosure of any contract specifications on financing, risk-sharing, and profit-sharing.
AMS requested comment on whether refusing to deal should be considered a specific prejudicial or disadvantageous action against covered producers.
AMS addressed concerns of vagueness by further defining conduct that is prejudicial or disadvantageous to producers in the final rule (as described in section V—Changes from the Proposed Rule). In particular, AMS has made a number of changes to provide additional clarity, specificity, and certainty to market participants relating to the list of adverse actions set forth in § 201.304(a)(2). In response to the commenter's concern that “generally or ordinarily offered” is a concept that may vary with market conditions over time, AMS revised the regulation to state “generally or ordinarily offered to
Nevertheless, AMS reads the statutory term “prejudicial” to be a broad term, that covers all acts that cause harm to covered producers on a prohibited basis with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry. While the term “prejudicial” encompasses a broad range of conduct, it is not vague. This rule does not prohibit all harms that may be inflicted on covered producers by regulated entities, rather, only those prejudicial acts related to livestock, meat and poultry that occur on a prohibited basis.
Moreover, the members of the trade association were mistaken even with respect to the original proposal protecting market vulnerable individuals. Regulated entities are free to use contracting tools to develop incentives. But a tool used to unduly prejudice the vulnerable does not incentivize; it oppresses. Any other conclusion is contrary to the plain meaning of the Act. This rule aims to create an inclusive, fair, and equal environment for farmers and ranchers to conduct business by preventing instances of unjust discrimination and undue prejudice. The key concept here is that there shall be no discrimination on the protected bases regarding the offering of “general and ordinary” contract terms. AMS concludes that the benefits of protecting farmers and ranchers from plainly unjustly discriminatory treatment outweigh the hypothetical prediction that such regulations will hamper efficiency or innovation. Inclusive markets breed innovation and efficiencies; they do not undermine them.
AMS requested comment on whether the four specific prejudicial acts are appropriate as proposed, or whether there are other forms of prejudicial
In the final rule, AMS has added paragraph (a)(2)(vi) to address any other action that a reasonably covered producer would find materially adverse. If a covered producer can show they are materially harmed by information asymmetry, they will have a recourse under this rule. Additionally, the prejudicial act of differential contract performance or enforcement (§ 204(a)(2)(iii)) covers selective information disclosure in many circumstances. Withholding materially relevant information from a contractee that it previously made available to the contractee or which it makes generally or ordinarily available as part of its contract performance to other contractees is de facto differential contract performance or enforcement. A producer is likely to operate in a less-than-optimal manner regarding financial renumeration when the regulated entity it is contracting with has withheld materially relevant information that has been disclosed to other contractees. Such behavior will thus lead to differential contract performance or enforcement.
AMS has not adopted the wide-ranging proposal on information asymmetry from the 2010 GIPSA Rule because it could inhibit the ability for regulated entities to select trusted partners with whom to engage in more complex, value-added production that may require specialized cooperation and information sharing.
Addressing information asymmetry and improving transparency in interactions between covered producers and regulated entities is a focus of AMS and will continue to be a priority in rulemaking. AMS made no further changes to the provisions regarding undue prejudices in response to this comment.
AMS sought comment on whether there are other types of purchase agreements (outside of those generally or ordinarily offered), such as forward contracts, formula contracts, AMAs, or cash market purchases, that could be used in a prejudicial manner. AMS requested identification of these types and examples of how they have been used to target vulnerable individuals or cooperatives.
AMS requested comment on whether other differential contract terms not listed in the proposed rule should be included when defining contract terms that are less favorable than those generally or ordinarily offered.
1. Bonuses offered to select producers, which would disadvantage other producers who do not receive bonuses.
2. “Cost-sharing.”
3. “Cost-plus contracts” where a regulated entity agrees to pay all the costs associated with purchasing and growing livestock, which disadvantages producers who do not receive cost-plus contracts.
AMS requested comment on whether AMS should include among the prejudices the action of offering less favorable price terms, contract terms, and other less favorable treatment in the course of business dealings than those generally offered to similarly situated producers.
AMS requested comment on whether an allowance be made for offering less favorable price or contract terms, or other less favorable treatment due to legitimate business reasons.
Commenters expressed concern that the proposed rule did not define legitimate business justification. Commenters expressed concern that the proposed rule fails to provide the industry with specific exceptions or justifications for disparate treatment of producers, stating there are multiple reasons why different (less favorable) terms may be offered to certain producers and not others, and that these reasons are not insidious in nature but instead a result of market forces and other nondiscriminatory factors. Additionally, several poultry industry commenters noted that AMS suggests in the preamble a legitimate business reason may justify disparate treatment, yet it never explains what constitutes a legitimate business reason. Several poultry industry commenters provided examples of reasonable business decisions that would result in differential treatment and may violate the proposed rule as written despite their reasonableness. These commenters urged AMS to add regulatory text similar to that in § 201.211 to expressly protect reasonable business conduct and specify how a company would demonstrate that an action was based on a reasonable business decision. The commenters also said that, due to the complicated nature of business relationships, business decisions should be presumed reasonable unless proven otherwise. A poultry industry trade association provided examples of complex fact patterns and asked, given each situation, how the regulated entity could demonstrate actions were taken for appropriate reasons.
An industry association contended proposed § 201.304(a) would eliminate the statutory requirement in 7 U.S.C. 192 that adverse actions against a market vulnerable individual are only prohibited if they are undue or unreasonable. The commenter noted the statute only prohibits “undue or unreasonable” advantages and disadvantages, meaning advantages or disadvantages that lack a reasonable business purpose. However, the commenter pointed out that, under the proposed rule, if the action is “adverse” and it impacts a market vulnerable individual, even if it was based on a legitimate business reason, the regulated entity would be in violation of the regulations. The commenter also noted that enforcing contract rights is often “adverse against” the other party, but “adverse” does not mean inappropriate or unfair. Commenters cautioned the proposed rule may result in regulated entities giving all producers the same contract terms to avoid litigation, which would eliminate the market competition the Act was intended to protect.
AMS is adopting the religious exception to recognize the important role ritual slaughter plays in certain religious traditions. AMS is also recognizing the important roles that Tribes play as governmental units and operators of economic enterprises. In those governmental activities, as interpreted by the Supreme Court as well as Federal laws governing Tribal affairs, Tribes may require the flexibility to only purchase livestock from or sell meat to their members. AMS believes that actions following these two
AMS underscores that, in this rule, legitimate justification only applies to whether adverse actions against covered producers on a prohibited basis are still permissible. Where the adverse action is
AMS disagrees with the comment that § 201.304(a) would eliminate the statutory requirement that a prohibited prejudice, disadvantage, or discrimination is undue, unreasonable, or unjust. To the contrary, AMS finds that prejudice, disadvantage, or discrimination on the prohibited bases set forth in this final rule to be per se unjust, undue, and unreasonable. As commenters to this rule have acknowledged prejudicial treatment on the prohibited bases has no place in the market.
AMS proposed addressing retaliation by outlining protected activities that a covered producer may engage in but that a regulated entity may not use as grounds for unjust discrimination or undue prejudice or disadvantage. The proposed regulations would have prohibited regulated entities from retaliating against covered producers for participating in a protected activity by terminating contracts, adversely differential performance or enforcement of a contract, refusing to renew contracts, offering more unfavorable contract terms than those generally or ordinarily offered, refusing to deal, interfering with third-party contracts, or other actions with adverse impact to covered producers. These proposed regulations are adopted in this final rule.
AMS requested comment on whether the proposed prohibition on retaliation would assist producers in avoiding unjust market discrimination, accessing markets, obtaining meaningful price discovery, or preventing anticompetitive practices.
An agricultural advocacy organization said § 201.304(b) as proposed fits easily within the scope of the Act's prohibitions on undue prejudice and unjust discrimination, closes a key enforcement gap, and represents a solid first step toward prohibiting unfair retaliation. An agricultural and environmental organization expressed support for the proposed provision but urged AMS to strengthen the final version. The commenter said regulated entities have deeply embedded retaliation into their business practices, leaving producers too intimidated to expose industry abuses. The commenter also cautioned that meat processors and live poultry dealers may attempt to find novel ways to retaliate against producers that do not directly violate the proposed rule, suggesting AMS broaden the range of protected producer activities and of prohibited retaliatory behavior.
A poultry grower expressed support for the protections, saying integrators had taken measures, such as delivering poor inputs and imposing extended timeouts on flock placements, against him and other growers who spoke up against abusive integrator practices. This commenter also said cattle and pork producers take similar actions against producers who expose problematic practices. A meat industry trade association said the proposed rule would ensure that farmers and ranchers have access to a public forum necessary for open, transparent communication. Numerous individuals indicated support for the proposed rule's protections against retaliation, with many saying the proposed rule would allow farmers to engage in whistleblowing actions without facing repercussions and would thus promote consumer, environmental, and animal welfare concerns.
AMS requested comment on whether the specific retaliation acts listed in the proposed rule are appropriate. AMS also sought comment on whether there are other forms of retaliatory conduct that should be specified.
AMS requested comment on whether termination or non-renewal of contracts is appropriate as a specific retaliation act listed in the proposed rule. It noted that covered producers have expressed fear of this type of retaliation through communication with AMS personnel and in comments on previous related rulemakings.
AMS requested comment on whether interference in farm real estate transactions or contracts with third parties is appropriate as a specific retaliation act listed in the proposed rule.
AMS requested comment on whether the specific acts of retaliation in the proposed rule are appropriate, and whether there are other forms of retaliatory conduct that should be specified.
AMS requested comment on whether prohibitions on retaliation should protect producers who choose not to participate in protected activities. AMS provided the example of whether the provision should prohibit giving premiums or discounts for joining or not joining livestock or poultry associations.
AMS requested comment on whether the bases of protected activities were appropriate, including the criteria for selection and application of those criteria. It further sought comment on whether the bases of protected activities are too broad, are too narrow, or should be changed in any other way. Comments received in response to this general inquiry are outlined below.
Several agricultural advocacy organizations said AMS should make clear that the proposed rule would protect producer communication with any sector or level of government by including all three branches of government in this provision, with one commenter also recommending AMS specify this provision applies to both State and Federal government.
Several commenters recommended revised text as follows:
“(i) A covered producer communicates with a government agency,
AMS requested comment on whether assertion of rights granted under the Act, 9 CFR part 201, or contract rights is appropriate to include as a protected activity under § 201.304(b)(2).
With respect to the assertion of any civil right, the protected activities enumerated in § 201.304(b)(2) were chosen because of their nexus to the business relationship between regulated entities and covered producers with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry. To the extent that a contract between a regulated entity and a covered producer includes representations and warranties, including implied ones, relating to either party's compliance with other Federal or State laws, such as labor, health, and safety practices, this provision would extend to communications relating thereto. AMS notes that the protection afforded in § 201.304(b)(2)(vi) covers supporting or participating as a witness in any proceeding with the regulated entity. The rule does not change any additional protections that may be provided under other Federal or State anti-retaliation laws.
With respect to the request that AMS revise the rule to clarify that producers cannot waive rights covered by the rule, AMS believes that the commentors are mistaken about the structure of the Act and its regulations. AMS enforces this rule. Irrespective of any agreement between the contracting parties, AMS does not waive its responsibilities to enforce the Act. The Act and regulatory scheme are designed to vindicate the public interest in fair and honest markets. Thus, AMS regularly brings its own enforcement actions to sanction companies that violate the provisions of the Act, irrespective of the contracting parties' waivers of liability. A regulated entity that seeks a waiver from a producer through undue prejudice, retaliation or deception still violates the general provisions of the Act by using a deceptive, unfair, or unjustly discriminatory practice.
To the extent that individuals waive their rights, AMS points the commenter to existing regulations at 9 CFR 201.218, which limit the use of mandatory arbitration clauses, as mandated by Congress in the 2008 Farm Bill (Pub. L. 110-246). Specifically, those regulations require that the regulated entity offer the producer or grower a specific disclosure regarding the ability to decline a mandatory arbitration clause and indicate that failure to accept or decline the arbitration clause will be treated as if the clause is declined. Additionally, the regulation sets out criteria governing the reasonableness of the arbitration clause. Arbitration is a procedural forum that some parties may utilize to adjudicate substantive rights; arbitration clauses cannot waive substantive rights under contracts or the Act.
Accordingly, AMS is making no changes to the rule in response to these comments.
AMS requested comment on whether assertion of the right to form or join a producer association or collectively process, prepare for market, handle, or market livestock or poultry is appropriate to include as a protected activity under § 201.304(b)(2).
A whistleblower advocacy organization said it supported the
Multiple individuals said participation in producer organizations and associations helps provide farmers with more access to information relevant to their businesses and promotes competition by enabling the production of better-quality products. A former trade association CEO said the social and informational benefits of association membership are especially important in the farming industry because of its potential for isolation. This commenter further suggested large agricultural companies would do well to appreciate the benefits of producer participation in such organizations, such as opportunities to make progress on solving problems, develop industry consensuses for presenting to government, and hear the perspectives of members with opposing views. An individual said producer organizations often act as a barrier between individual producers and consumers, and the proposed rule would prevent producer organizations from retaliating against producers who try to change this behavior and provide truthful information about the conditions under which their products are grown or raised. The commenter said this would protect farmers' right to organize to improve their pay and working conditions.
Additionally, AMS appreciates that producer organizations may at times be at odds with their producer members. However, producer organizations are not considered regulated entities under this rulemaking, and thus retaliatory conduct at the hands of such organizations is not covered. Producers have the choice to join or separate from such organizations based on their individual feelings surrounding the costs and benefits such membership brings. If producers feel as though their membership of an organization is serving as a barrier between them and consumers, thus preventing transparency regarding growing conditions, producers may find it advantageous to disassociate. Often producers do not have this luxury in their relationship with packers and integrators due to their reliance on these regulated entities and the absence of alternative buyers due to regional concentration.
AMS requested comment on whether communication or cooperation for purposes of improving production or marketing of livestock or poultry is appropriate to include as a protected activity under § 201.304(b)(2).
AMS requested comment on whether supporting or participating as a witness in any proceeding under the Act or a proceeding relating to an alleged violation of law by a regulated entity is appropriate to include as a protected activity under § 201.304(b)(2).
“(viii) A covered producer engages in any lawful conduct for the purpose of improving production or marketing of livestock or poultry.”
A farmers union said AMS should broaden the grievance-sharing activities producers can participate in to give producers more protection from retaliation.
An agricultural advocacy organization said AMS should protect the ability of producers to freely associate with other farmers and other organizations, including using social media or other communication platforms.
An agricultural and environmental organization said AMS should expand the list of protected activities to include situations in which producers maintain their status as independent participants on open markets, refusing to enter into forward contracts or other contractual agreements that set future price or performance at the regulated entity's request. According to the commenter, producers who resist entering into forward contracts and AMAs often face retaliation, and therefore the final rule should protect them. The commenter recommended AMS add another paragraph to § 201.304(b)(2) as follows:
(vii) A covered producer refuses to sell livestock or poultry through forward contracts, AMAs, or similar contractual arrangements, opting instead to engage in open market sales.
An organization said lawful communications protected under the proposed rule should also include situations where a complainant provides information regarding conduct that they reasonably believe violates the Act or is about to do so. The commenter said that, because most people are not experts on their rights under the Act, the proposed rule should establish that complainants do not need to mention specific violations and that, as with similar corporate anti-retaliation measures, they do not need more than a subjective, good faith belief that the conduct at issue violates the Act. The commenter also said AMS should allow these complaints in any language and by means including in person, in writing, and by email.
An academic institution said the protected activities listed in the proposed rule are all important in empowering producers to assert their rights and promote fair markets.
AMS notes that communication with other producers for the purposes of improving the production or growing of livestock or poultry is already protected by the proposed regulation. Such communication may include sharing grievances over practices by regulated entities or others as such communications relates to covered producers' desire to overcome obstacles to improving or marketing their livestock or poultry.
AMS acknowledges a commenter's concern regarding some covered producers' interest in not utilizing forward contracting for the sale of livestock. However, regulating whether covered producers have a right to any particular form of livestock sales transaction is outside the scope of this rule.
AMS underscores that, to obtain the protection of this regulation, the producer need not engage in any particular form of the activity, such as quoting a precise regulatory section to assert an Act right. The focus will be on the substance of the producer's activities, and a good faith effort to assert an Act or contractual right is still protected from retaliation
Accordingly, AMS did not make any changes in response to the comments.
AMS asked for input regarding whether protected activities related to communication and cooperation should be limited to USDA extension and USDA-supported non-profit entities, beyond government entities.
An academic or research institution and several organizations said, given the information asymmetry and lack of transparency in livestock and poultry production markets, AMS should extend protection to more types of communications that producers may want or need to pursue in preventing market exclusion and asserting their rights and protections. Commenters suggested AMS should protect producer social media posts about unfair integrator treatment, as well as producer communications with relevant third parties, such as lawyers and legal aid organizations, veterinarians and others doing work related to animal welfare, producer advocacy organizations, and the media.
Several commenters said AMS should introduce this provision in a new § 201.304(b)(2)(ii), with other commenters providing the following variations on recommended regulatory text:
(ii) A covered producer takes an action through a non-governmental third party that causes the producer's grievances against a regulated entity or a group of regulated entities to be known.
and
(ii) A covered producer communicates with a reporter, private investigator, public interest organization, or the general public through traditional media or social media with respect to any matters related to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry; so long as such communication does not expose a trade secret a regulated entity has reasonably and clearly identified in writing as a sensitive and confidential trade secret. A regulated entity's claim that any communicated information is a sensitive and confidential trade secret is not reasonable if the information is publicly available, shared by the regulated entity to any third party that is authorized to disseminate the information, or exposes standard industry practices common
Whether social media communications are covered will depend on the protected activity in question and the particulars of the social media forum in question. Whether a public post by a covered producer about treatment by a regulated entity that the covered producer asserts to be in violation of the Act or is otherwise harmful to the producer may depend on the facts and circumstances of the post. For example, to the extent that the producer is testifying to Congress or courts regarding unfair treatment and the social media post simply refers to the testimony or describes the same material, then, for example, such a post would likely be protected, depending on the full scope of the facts and circumstances.
Similarly, if the social media post is part of an effort to share information with other producers for the improvement of production or marketing or is part of an effort to form an association or engage in cooperative activities, that would likely be protected under this rule as well since the rule is agnostic as to the form of the communications between producers. However, AMS notes that the activities protected under this rule are covered to the extent that these activities are not otherwise prohibited by Federal, State, or Tribal law. For example, the rule does not provide an exemption from defamation laws.
Nor does this rule attempt to preempt freedoms of the press. Whether a communication with a reporter or public investigation organization is covered will depend upon the facts and circumstances. The inquiry would need to balance the important role that freedom of the press plays in maintaining market integrity with legitimate expectations by a regulated entity of good faith behavior by a producer under a contract. Relevant questions include whether the communication was part of a factual effort to assist the reporter in understanding and reporting on asserted violations of law and regulation and whether the producer provided any confidential business information to the investigator or otherwise exposed the regulated entity to commercial risk or reputational damage unrelated to the violation in question. Also potentially relevant, in some circumstances, may be whether the producer has exhausted other avenues for resolving any dispute and also the extent to which the regulated entity has a reputation recognized in the market for retaliation which would otherwise place the producer in fear of asserting rights even with the presence of this rule.
The rule does not provide unlimited license for producers to damage the reputation of regulated entities. A social media post principally functioning as a threatening or coercive public communication is unlikely to be covered, absent other extenuating facts and circumstances. AMS underscores that the rule is intended to facilitate lawful communication and the exercise of lawful economic rights by covered producers, and the promotion of competitive markets and markets with integrity. That goal is most effectively served by enabling producers to exercise contractual and legal freedoms, communicate with government, other producers, and competitor firms for the purposes set forth in this rule. Therefore, AMS makes no changes to the rule in response to these comments.
AMS requested comment on whether the proposed anti-retaliation provision provides sufficient protection for all types of covered producer business organizations.
AMS requested comments on whether protections for exploring a business relationship with a regulated entity are sufficient, or whether such protections should extend to exploring business relationships with any person, in addition to regulated entities.
Several commenters recommended the following revisions to § 201.304(b)(2)(v):
(v) A covered producer communicates or negotiates with a regulated entity, other commercial entity, or relevant consultant for the purpose of exploring a business relationship or alternative use or application of their property.
AMS requested comment on whether the proposed list of retaliatory actions should include a catch-all clause, such as “offering contract terms that are less favorable than those generally or ordinarily offered.”
(v) Offering unfavorable contract terms in contract formation, contract modification, or contract renewal that affect reprisal.
(vi) Any other action that adversely impacts a covered producer's financial or reputational interests or may result in diminished contract performance with the regulated entity.
Unfavorable contract terms include, but are not limited to: price terms, including any base or formula price; formulas used for premiums or discounts related to grade, yield, quality, or specific characteristics of the animals or meat; the duration of the commitment to purchase or to contract for the production of animals; transportation requirements; delivery location requirements; delivery date and time requirements; terms related to who determines date of delivery; the required number of animals to be delivered; layout periods in production contracts; financing, risk-sharing, and profit-sharing; or terms related to the companies' provision of inputs or services, grower compensation, or capital investment requirements under production contracts.
Additionally, AMS accepts the commenters' critique that the proposed regulatory text was insufficiently specific to provide clarity regarding when regulated entities could and could not take adverse actions against covered producers. In particular, AMS is concerned that the proposed contours regarding refusals to deal and non-renewals offer regulated entities too great a latitude to engage in retaliation, because a regulated entity could, in theory, satisfy the proposed rule by simply offering highly unfavorable terms to the covered producer—which it could not do if the agency prohibited “offering of contract terms that are less favorable than those generally or ordinarily offered.” That is not, however, the intent of the regulation. Rather, it is to ensure that covered producers, in whatever circumstance they enjoy, do not suffer retaliation for effectuating their rights under the Act.
Accordingly, in the final rule, AMS has amended the provision to add several clarifying details. First, the final rule clarifies that requiring modifications or only offering to renew contracts on terms less favorable than those enjoyed by the covered producer is a violation where it occurs because the covered producer engaged in protected activities. This provision covers any adverse change to the covered producer's terms to provide maximum flexibility to the covered producer to exercise protected rights regardless of the particular circumstances. Second, the final rule clarifies that a refusal to deal with covered producers would be triggered where the regulated entity fails to offer terms generally or ordinarily offered to other similarly situated covered producers. This provision does not guarantee the covered producer the most favorable contract terms in the market, but simply those that the covered producer would generally or ordinarily offer to other similarly situated covered producers that had not engaged in protected activities, which could include the situation previously enjoyed by the covered producer prior to having engaged in the protected activity. Such a provision is necessary because covered producers may enter or exit the market at different times, and during that period may engage in protected activities for which a regulated entity may attempt to retaliate. Together, AMS believes that these modifications cover the most common circumstances that covered producers may encounter in their business dealings in which regulated entities may attempt to exact retaliation.
AMS is not including the level of detail sought by some commenters regarding the specific form of retaliation. This rule is intended to provide protections for adverse actions against a covered producer based upon the protected activity (including threats intended to chill engaging in that activity). Any inquiry should focus on those bases, rather than on the particular form of the discriminatory harm. AMS recognizes that unfavorable
Additionally, AMS confirms that when a regulated entity claims that modification or renewal of a contract on less favorable terms is common with similarly situated producers for reasons unrelated to any exercise of protected activities, AMS will not automatically consider the less favorable modification or renewal a violation of this particular rule. AMS will, however, review modification and renewal and will carefully examine the regulated entity's justifications. Even outside of retaliation, unilateral modification of existing contracts has been a violation of the Act. The Act considers it an unfair and deceptive practice to modify an existing contract to either extend the time for payment or reduce the full price agreed upon at delivery. Moreover, contract modification has been a deceptive practice where the terms offered publicly were privately disavowed.
AMS requested comment on whether other contract terms should be included as part of including a non-exhaustive list of contract terms that could affect reprisal.
AMS requested comment on what challenges or burdens regulated entities may face in complying with the proposed rule's anti-retaliation provisions.
A cattle industry trade association said that AMS's decision to allow violations of the proposed rule's retaliation provisions without demonstrating harm to competition, along with ambiguous definitions letting a wide range of parties qualify as potential complainants, puts the cattle industry in danger of a huge wave of lawsuits that could thwart innovation. A swine industry trade association said the prohibited forms of retaliation listed in § 201.304(b)(3) include a broad range of activities that a regulated entity may have legitimate business reasons to carry out. According to the commenter, these prohibitions would restrict the rights of regulated entities to freely deal and require them to treat every producer the same, putting the proposed rule in conflict with the Act and with antitrust law. A poultry industry trade association and several live poultry dealers said that the list of activities that constitute retaliation is not exhaustive, so regulated entities have no way to know what activities they must avoid to comply with the rule.
The activities protected by this final rule each constitute an exercise of basic freedoms necessary and essential to maintain a free and competitive market—freedoms such as exercising contractual and legal rights, seeking recourse through governmental channels, forming cooperatives or associations relating to the business of livestock and poultry, and being a witness in court. Most regulated entities assert that retaliation for engaging in these types of activities is not a common practice in the industry. AMS finds that factually questionable, given the level of complaints and concerns expressed by producers over the years, including
AMS has further responded to the question of the costs and risks of litigation below.
Additionally, AMS rejects the comment that the regulated entity would face a burden because it would not know which protected activities the producer has engaged in. The purpose of the rule is for the regulated entity to not adversely treat producers based on their participation in protected activities.
AMS also rejects the comment that live poultry dealers would still need to determine how to treat particular growers when dealing with a cooperative. Cooperatives are independent entities, and the live poultry dealer would enter in a contract with the cooperative as a whole, rather than with any individual grower. The terms of the general contract would govern the relationship between the live poultry dealer and the cooperative. Generally, a cooperative is an organization established by individuals to provide themselves with goods and services or to produce and dispose of the products of their labor. The property of a cooperative, including the means of production and distribution, are typically owned in common. This rule prohibits live poultry dealers from discrimination against a cooperative because it is a cooperative or from retaliating against producers for forming a cooperative. Because a cooperative is an entity, a regulated entity cannot assert that they are dealing with a cooperative but then limit the agreement to individuals.
This commenter also said that, because farmers are often unfamiliar with protections that apply to their exposure of industry wrongdoing, USDA must make efforts to share information about producer rights and company responsibilities at the beginning of the contractual relationship as well as throughout the engagement. The commenter suggested that AMS host educational programming about rights under the Act and develop language-appropriate educational material. The commenter urged USDA and DOJ to continue to offer anonymous protected disclosures through their joint portal and be transparent about subsequent regulatory and enforcement activity, saying most producers prefer to make reports anonymously or through another party to avoid retaliation.
Furthermore, AMS is sympathetic to and broadly in agreement with the commenter's perspective that covered producers should not be required to understand the precise contours of the Act to exert their protected activity rights, and that they should be enjoyed heightened protection when acting at the express or implied direction of a regulated entity. Regulated entities have no motive to purposefully induce producers to commit unlawful acts. If a regulated entity induces criminal activity, irrespective of retaliation, this inducement may be deceptive within the meaning of the Act.
AMS appreciates the commenter's advocacy regarding the need for continuing USDA-sponsored education regarding producer rights and company responsibilities under the Act. AMS is taking steps to increase producer education and outreach, including, for example, establishing the
AMS proposed a recordkeeping requirement that records related to compliance with this rule be kept for a period of five years from the date of record creation. These records include policies and procedures, staff training materials, materials informing covered producers about reporting mechanisms and protections, compliance testing, board of directors' oversight materials, and records about the nature of complaints received relevant to prejudice and retaliation. AMS stated the purpose of this proposal was to reduce the threat of retaliation and to enhance AMS's ability to investigate and secure enforcement against undue prejudice and unjust discrimination.
AMS requested comment on whether the proposed recordkeeping obligations were appropriate to allow AMS to monitor regulated entities for compliance.
Other commenters supported the proposed recordkeeping requirements, but suggested AMS should require regulated entities to maintain additional specific records. A cattle industry trade association said AMS should require retention of any records that include specific terms (including prices paid) of purchase agreements or contracts, as well as any methodologies used to calculate premiums or discounts paid to producers. This commenter argued that such records would enable AMS to evaluate differential treatment. An agricultural advocacy organization made a similar suggestion for regulated entities to maintain income/payment formulas and pre-contract discussions with producers as part of their recordkeeping obligations.
AMS requested comment on whether the proposal should require regulated entities to produce and maintain their specific policies and procedures, compliance practices or certifications, or disclosures to ensure compliance with the undue prejudices and provisions and anti-retaliation provisions in the proposed rule.
An agricultural and environmental organization proposed regulated entities should be subject to an Annual Compliance Report to AMS that requires a detailed list of all their transactions. This list would include, specifically: (1) an anonymized list of producers the regulated entity did business with; (2) terms offered to producer during contract negotiations; (3) terms entered with producer and whether these terms differ with similarly situated producers; (4) prices paid to producers and methodology for the price; (5) whether AMAs were used; and 6) accounts of all instances of the regulated entity's refusal to deal with a producer and justification for the refusal. The commenter argued that it will be difficult for producers or AMS to prove violations of proposed § 201.304(a) without these detailed disclosures.
An agricultural advocacy organization proposed requiring regulated entities to report to AMS the contract terms and payments made to producers, as well as producer demographic information necessary to determine which producers are market vulnerable individuals. The commenter argued this was necessary to put the burden of enforcement of the new rule on AMS and regulated entities rather than covered producers. This commenter also suggested requiring regulated entities to use a uniform recordkeeping system that tracks and reports “relevant data” to allow AMS to monitor for potential differential treatment or discrimination. This commenter likened the proposed system to the Home Mortgage Disclosure Act, which allows regulators to use data from regulated entities to ensure compliance with fair housing laws.
AMS sought comment on what specific challenges regulated entities may face in complying with the recordkeeping duties of the proposed rule.
AMS is also declining to revise the regulation to limit the record retention requirement to two years. AMS believes that requiring that records be retained for five years from their creation date will enable the agency to monitor the evolution of compliance practices over time in this area and will ensure that records are available for what may be complex evidentiary cases. AMS will not be adding a warrant requirement to the rule at this time because the Agency already has jurisdiction under the Act to request documents concerning a regulated entity's business and therefore no warrant is required to do so under governing law.
AMS requested comment on how the proposed recordkeeping duties may differ from the current policies, procedures, or practices of regulated entities.
AMS proposed to prohibit regulated entities from participating in several types of deceptive practices with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry. These relate to contract formation, performance, termination, and refusal.
AMS requested comment on whether the proposed regulations accurately and adequately identify recurrent deceptive practices in the livestock and poultry industries, as well as whether any areas of deception may be missing.
Two agricultural advocacy organizations recommended that, in addition to the four broad prohibitions on behavior enumerated under proposed § 201.306, AMS should provide a non-exhaustive list of prohibited conduct known to harm producers, saying this measure would provide clear guardrails and foster quicker termination of abusive practices against producers. These commenters also said the deception provisions of the proposed rule fall well within AMS's authority under the Act, noting that Congress gave USDA broad powers under the Act with the intention of halting unfair trade practices against producers before producers suffer actual harm.
AMS proposed prohibiting regulated entities from:
• Making or modifying a contract by employing a pretext, a false or misleading statement, or an omission of a material fact necessary to make a statement not false or misleading (§ 201.306(b)).
• Performing under or enforcing a contract by employing a pretext, false or misleading statement, or omission of material fact necessary to make a statement not false or misleading (§ 201.306(c)).
• Terminating a contract or taking any other adverse action against a covered producer by employing a pretext, false or misleading statement, or omission of material fact necessary to make a statement not false or misleading (§ 201.306(d)).
• Providing false or misleading information to a covered producer or association of covered producers concerning a refusal to contract (§ 201.306(e)).
Several commenters recommended the following amended regulatory text, with changes in bold:
“(e) Contract refusal. A regulated entity may not
The final rule does not include “pretext” or “omission of material fact necessary to make a statement not false or misleading” in this refusal to contract provision because refusals to contract may occur for any number of reasons, and regulated entities may not always be in a position to reveal the reason for a refusal to contract. There may be economic, social, community, or even simply polite reasons for offering an incomplete, if not untruthful, reason for a refusal to contract. As long as a regulated entity is not providing false or misleading information to a covered producer or omitting material information, it will not run afoul of § 201.306(e).
AMS appreciates the commenter's concerns regarding the use of forward contracts. However, including a specific prohibition regarding this practice was not under consideration in the proposal. With this rulemaking, AMS is implementing regulations to provide a broad array of coverage against deceptive practices during various stages of the contracting process. Deceptive acts in contract refusal will be determined on a case-by-case basis based on the facts and circumstances of each individual case. In the example raised by the commenter, were a packer to refuse to purchase cattle in the cash market and state that its plant has acquired all the cattle it needs, the packer would not run afoul of the final rule if that statement was true. However, were the packer to make such a statement but would be willing—or attempt—to purchase the cattle under a different marketing arrangement, that would suggest that the information provided was false or misleading and the packer would run afoul of the final rule. If the cattle were of a quality or type that the packer does not want and the packer has already acquired all the cattle it needs for a given week, the packer could state that it is full without telling the covered producer its real reason for refusing to purchase cattle—again, as long as the statement provided is truthful.
Accordingly, AMS is not making any changes to the regulation as proposed in response to these comments.
AMS asked whether there were recurrent deceptive practices not
The commenter argued that many of these packer practices relating to AMAs are deceptive because they can induce producers to enter into contracts in which they do not fully appreciate the extent to which packers control the applicable risks. At a minimum, the commenter urged AMS to clarify that the proposed rule's ban on deceptive practices extends to packer manipulation of spot market prices to lower the price paid to independent producers at time of delivery. The commenter also stressed that it would prefer AMS to introduce a comprehensive prohibition of deceptive practices associated with AMAs to avoid placing the burden of identifying manipulation on individual producers. Specifically, the commenter recommended that AMS require forward livestock contracts to include a firm and predictable base price, so packers have no room to manipulate prices, citing the recent Cargill case under which DOJ alleged that contracts executed by major poultry processor defendants under the tournament system violated the Act. The final judgment agreed to by the parties and entered by the Court requires that the defendant processors pay contract poultry growers a firm and predictable base price.
Likewise, AMS has determined it will not add the commenter's suggested ban on packer-owned cattle and captive supply arrangements that use formula or basis price forward contracts. AMS believes more analysis is needed to ensure such intervention is appropriate.
(f)
(1) Demanding capital investments as a condition of contract renewal if such capital investment demands were not previously agreed to in writing between the covered producer and regulated entity.
(2) Demanding capital investments by a covered producer without commensurate and enforceable obligations on the part of the regulated entity that will reasonably allow the covered producer to recover the demanded capital costs plus a reasonable return.
(3) Refusing to deal because the livestock producer is selling livestock on the cash market rather than through a contract arrangement and the livestock is otherwise marketable.
(4) Failing to provide a guaranteed base pay in Alternative Marketing Agreements, production contracts, or other similar arrangements.
(5) Inequitably distributing inputs such as animal placements, feed, veterinary care, or other inputs controlled by a regulated entity that can impact a covered producers' performance or compensation.
(6) Shifting environmental compliance costs or responsibilities exclusively to a covered producer when the regulated entity exercises substantial operational control, through contract or otherwise, over the producer through an ownership interest in the livestock or poultry, land or other capital, or control of a covered producers' activities, inputs, management and waste management practices, or capital investments.
AMS requested comment on whether deception in contract refusal should be governed by the categorial approach as proposed, or whether it should be governed by a single statement setting out one standard for contract formation, performance, and termination. It also requested comment on whether it should structure deception around prohibiting the deceptive pretext, statement, or omission, rather than prohibiting the contractual activity based on the deceptive statement or omission as proposed. In addition, it requested comment on whether the prohibitions on “employing” certain false or misleading statements, pretexts, and omissions in the formation, operation, etc., of a contract appropriately capture the importance or effect of the misleading statement, such as its material or relevance to the producer or the formation, operation, etc., of the contract. Alternatively, it asked whether it should prohibit a regulated entity from employing any pretext, false or misleading statement, or omission of material facts necessary to make a statement not false or misleading, in connection with making, enforcing, or cancelling a contract. AMS also asked if there was a better way to approach the issue, such as using elements or defenses.
AMS requested comment on whether there are other elements, such as the reasonableness of the recipient, that it should explicitly consider in a rule on deception.
AMS requested comment on specific challenges or burdens regulated entities might face in complying with the deceptive practices provisions of the
A swine industry trade association said the deceptive practices provisions would likely lead to costly litigation because the rule is overly broad and vague in its description of prohibited conduct. For example, according to the commenter, the proposed rule does not provide any definition or guidance on what constitutes a “material” fact, which is deceptive if omitted, and its ban on deceptive practices with respect to “any matter” related to livestock, meats, or live poultry does not clearly establish the scope of conduct at issue. In addition, the commenter said much of § 201.306 is unnecessary because other laws already sufficiently restrict the conduct at issue.
AMS must help ensure that regulated entities are truthful in their dealings with producers. Under these rules, AMS would seek to uncover the real motive for a regulated entity's treatment of a producer with whom they are forming or have a contractual relationship. AMS is including a prohibition against false or misleading statements, or omission of material information necessary to make a statement not false or misleading (in paragraphs (b) through (d)) to protect producers from conduct that employs deceit to disguise a regulated entity's genuine motive. Over the years, producers have reported concerns regarding their inability to understand and appreciate the real reasons why regulated entities take certain actions against them, in particular with respect to certain actions such as reduced chick placement or contract termination. For example, producers have asserted that sometimes a regulated entity will suddenly enforce certain parts of a contract in a stricter manner—such as animal welfare guidelines—even though the regulated entity had earlier found the producer's conduct under the contract acceptable. Producers assert that this is an example of a form of retaliation for actions by the producer or a deceptive practice to accommodate unrelated economic decision-making. Producers need to understand the real reasons for regulated entities' decision-making both to protect themselves from specific inappropriate adverse actions (such as undue prejudice or retaliation) and to be able to compete more effectively in a concentrated marketplace. If they cannot learn the real reasons why certain actions are taken against them, they cannot plan or mitigate the risks they may face. Therefore, AMS believes it is crucial to establish a regulatory framework prohibiting deceptive practices in contracting. AMS believes such a framework should provide broad, non-exhaustive prohibitions to provide better coverage for producers against deceptive practices in various stages of the contracting process. AMS may refine this framework via future rulemakings if the need arises.
With respect to the commenters' view that AMS does not provide guidance on how it defines “pretext” or how a regulated entity would demonstrate that an explanation is not pretextual, AMS adopted clarifying language by withdrawing its use of “pretext” and relying on the prohibition against employing a “false or misleading statement.”
With respect to the commenters' critiques regarding the materiality standard, under the FTC's Policy Statement on Deception, “material” refers to information that would affect a consumer's—in this case, producer's—conduct or decision-making, from the perspective of a producer acting reasonably under the circumstances. Act precedent may not require AMS to follow FTC's precedent in all circumstances, but AMS has designed the rule to satisfy the approach set forth in the FTC Policy Statement on Deception in this set of deceptive practice prohibitions. AMS is not seeking to establish a “but for” standard; however, the materiality of the information is already embedded in the regulated entity's act of “employing” the omission on which the covered producer has relied on in the contracting activity under § 201.306. Commenters also expressed concern about § 201.306's prohibition against the omission of material facts, questioning whether compliance would require that regulated entities mention every business reason that contributed to a decision even if other factors were more relevant. AMS notes that proposed § 201.306(b) through (d) specified that the prohibition applies to the “omission of material fact necessary to make a statement not false or misleading.” If one of the factors that contributed to a regulated entity's business decision was not material or relevant, then the omission of that information would be unlikely to make a statement false or misleading from the perspective of a producer acting reasonably under the circumstances. AMS therefore made no changes to the proposed regulations in response to this comment; however, AMS notes that as discussed in Section V—Changes from the Proposed Rule, AMS made several changes to the verbiage of § 201.306(b) through (d), including replacing the phrase “omission of material fact” with “omission of material information.”
In response to commenters' concerns regarding the potential for increased litigation, AMS acknowledges that the provisions of § 201.306 could result in additional litigation because the regulations could provide producers new hope for relief from deceptive conduct in the contracting process. However, as discussed in more detail in this rule's Regulatory Impact Analysis in Section VIII.B., AMS does not expect large increases or decreases in litigation from this rule. Though commenters expressed concern that this regulation will lead to costly litigation because it is too broad and vague, AMS notes that in this final rule the Agency has provided additional clarity on the meaning of “material” in these
With respect to the commenter's view that § 201.306 is unnecessary, AMS disagrees. AMS believes that, while USDA regulations prohibiting specific deceptive practices already exist, a regulatory framework prohibiting deception during the contracting process is necessary because this will provide much-needed certainty and predictability to the interpretation of this section of the Act.
AMS requested comment on whether it should propose specific recordkeeping provisions relating to deceptive practices and what such practices should include.
AMS is not adopting the commenter's suggestion regarding examples of contract terms and procedures related to tournament settlements and input quality because they are outside the scope of this rule. AMS made no further changes in response to the comments.
AMS requested comment on whether all contracts with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry should be in writing.
A plant worker indicated support for requiring all contracts to be in writing, while noting that some benefits would be limited. According to the commenter, introducing this type of requirement would help producers by providing a record of the transaction and an increase in transparency. However, the commenter also said such a requirement would be less likely to address packer pressure on producers to use formula market arrangements to incentivize cattle quality if the packers present these arrangements as take-it-or-leave-it offers, although it would at least help create an environment that is transparent about material terms. The commenter also said that many jurisdictions may already require contracts to be in writing to satisfy the statute of frauds, especially if they cover multiple years, thus making a provision requiring written contracts potentially redundant in some cases.
AMS requested comment on whether a failure to continue to buy in the cash market, following a regular or dependable pattern or practice of such buying, should be treated for the purposes of this proposed rule as more similar to termination of a contract, rather than as refusal to deal.
AMS proposed adding a new provision to 9 CFR part 201 of the Packers and Stockyards regulations ensuring that if any provision—or applicability of any provision—of subpart O was declared invalid, the validity of the other provisions of subpart O would be unaffected. AMS noted this is to provide a reviewing court some guidance on the Agency's position on how the rule is intended to function.
Pursuant to the requirements of Executive Order 12866, AMS conducted a cost-benefit analysis of the proposed rulemaking by considering three regulatory alternatives: (1) maintaining the
With respect to commenters' assertion that AMS has neglected to account for labor costs, including legal services, AMS notes that in the proposed rule's Paperwork Reduction Act analysis, AMS provided a compliance cost breakdown for the hours required of attorneys, as well as administrative assistants, managers, and information technology staff. AMS does not expect large increases or decreases in litigation costs, and thus regulated entity legal services. The clarity provided by the rule encourages regulated entities to proactively avoid prejudicial, discriminatory, and deceptive practices that could otherwise lead to costly litigation. Likewise, the rule could also provide producers hope for relief from the courts for perceived prejudicial, discriminatory, and deceptive practices, which could, in turn, increase litigation but would return benefits to producers in reduced harms. In response to commenters' concerns regarding the costliness of the rule's recordkeeping requirements, AMS argues that the recordkeeping requirements were crafted to provide flexibility for regulated entities. The rule does not prescribe the manner in which records must be stored. If a regulated entity finds the cost of filing cabinets prohibitive, the entity may choose whichever means of file retention is most cost effective, including currently available computer filing systems, which most companies maintain in the normal course of business. Additionally, the rule provides regulated entities leeway to determine which records they choose to maintain. Because this rule applies to regulated entities across a
Accordingly, AMS makes no changes to the rule in response to these comments.
A live poultry dealer echoed this concern, citing USDA's acknowledgement in the previously proposed 2016 Farmer Fair Practice Rule that rolling back the harm to competition requirement would “inevitably lead to more litigation in the livestock and poultry industries.”
An industry trade association suggested that millions of dollars per year would be required to litigate, define, and refine the terms of the new rule due to ambiguity. It said that frivolous litigation that misunderstands or capitalizes on vagueness in the rule would add significant litigation costs. The trade association estimated the cost of compliance with the new rule (including anticipated litigation) to be more than $100 million to the industry. It cited independent economic analyses of previous AMS rulemakings on similar topics that estimated economic impact costs exceeding $1 billion,
In response to commenters' complaint that AMS has overlooked significant litigation costs that would be inevitable under the proposed regulations, AMS does not expect large increases or decreases in litigation costs. The clarity provided by the rule encourages regulated entities to proactively avoid prejudicial, discriminatory, and deceptive practices that could otherwise lead to costly litigation. This effect would lead to a decrease in litigation costs. Likewise, the rule could also provide producers hope for relief from the courts for perceived prejudicial, discriminatory, and deceptive practices, which could, in turn, increase litigation costs but would return benefits to producers in reduced harms. AMS is uncertain as to which effect will dominate and to what extent and, therefore, does not estimate litigation costs in this analysis.
With respect to the comments regarding compliance costs for the 2016 Farmer Fair Practice Rule, commentors discussed that a trade association estimated the cost of compliance with rule (including anticipated litigation) to be more than $100 million to the industry. A commentor also noted that an independent economic analyses of previous AMS rulemakings on similar topics that estimated economic impact costs exceeding $1 billion. The 2016 Farmer Fair Practice Rule was a very different proposed rule with a much wider scope than this final rule, and AMS does not consider a comparison of the 2016 Farmer Fair Practice Rule and this final rule to be an accurate comparison. The costs of this final rule are much smaller than the estimated costs of the 2016 Farmer Fair Practice Rule. GIPSA estimates the average litigation cost of the 2016 Farmer Fair Practice Rule to be less than $9 million in the first year. Given the scope of this final rule is smaller than the 2016 Farmer Fair Practice Rule, AMS expects litigation to be smaller. This, combined with the offsetting effects of the increases and decreases in litigation, leads AMS to not consider adding litigation costs to the rule.
The assertion that packers will be forced to standardize all contracts to ensure conformity with the rule is without basis. Standardizing contracts may be one way to ensure fair treatment of producers, however, this rule in no way mandates such a response from packers. Similarly, AMS disagrees with the assertion that fear of litigation would remove any incentive to contract with individual poultry growers. The aim of the rule is to discourage abuses of power in the marketplace to allow qualified producers to participate freely in the market and receive full value for their efforts. Reliance on individuals to raise poultry evolved as an economically advantageous way for integrators to bring poultry to the market. AMS does not believe that a greater focus on ensuring honest dealing and honest decision-making is incompatible with this model. Further, AMS disagrees with the assumption that a regulated entity would need to abstain from contracting with individuals to ensure that they are not abusing their market power by operating in prejudicial, retaliatory, or deceptive ways.
With respect to the comments regarding rules previously published by GIPSA, AMS notes that GIPSA's withdrawal of its 2016 rules was justified in part due to the rules' lack of clarity regarding prohibited behavior and the agency's perception that such ambiguity would increase litigation costs. This rule differs from the GIPSA rules by more clearly and specifically laying out the types of conduct that will
With respect to the “vague standards” giving rise to increased litigation specifically, AMS has taken note and addressed clarity in this rule.
Further, AMS will review the facts and circumstances of each case and the regulated entity's justifications for any alleged adverse treatment to determine whether the regulated entity has violated this rule. AMS is making no changes to the rule in response to these comments.
AMS chose final §§ 201.304 and 201.306 over the Small Business Exemption Alternative because AMS wishes to prevent the kind of undue prejudices and unjust discrimination described in the rule. AMS believes that keeping relevant records will help promote compliance with this rule, that all packers, live poultry dealers, and swine contractors cannot purchase livestock or enter into contracts for growing services with the kind of undue prejudices and unjust discrimination described in the rule. All packers, live poultry dealers, and swine contractors cannot purchase livestock or enter into contracts for growing services with the kind of undue prejudices and unjust discrimination described in the rule.
AMS recognizes that section 1981 of the Civil Rights Act establishes that certain rights are to be guaranteed, and these rights are to be protected against impairment by nongovernment and state discrimination. This rule addresses prohibited conduct specifically in the agricultural sector and is not superseded by section 1981. By expressly stating prohibited conduct that is violative of the Act, this rule seeks to allow AMS to better enforce the Act. AMS acknowledges that multiple USDA-administered statutes explicitly refer to socially disadvantaged groups and socially disadvantaged farmers or ranchers but underscores that AMS has replaced the definition of “market vulnerable individual” (which was more closely aligned with the formulations under those laws) with a simpler set of prohibited bases. And for the reasons described above, AMS's interpretation of the Act is faithful to its text and purposes. AMS notes that comments indicated that the Act in fact does prohibit the conduct set forth in this rule, in which case the rule will function to clarify and explicate already prohibited conduct.
AMS notes commenters' argument that § 201.304(a) covers similar conduct as the Civil Rights Act of 1964, the Agricultural Fair Practices Act (AFPA), and the Robinson-Patman Act. However, the fact that such conduct is prohibited under those statutes does not mean that it is not also prohibited by the P&S Act, which is broader in scope than other antitrust laws.
Similarly, AMS disagrees with commenters' argument that § 201.304(b), which prohibits retaliation, is unnecessary because these protections are already afforded by the AFPA, the Capper-Volstead Act, and other laws which specifically protect farmers from retaliation for acting as a witness in a Federal investigation. USDA has continually received complaints from producers regarding retaliatory practices. Therefore, AMS concludes that promulgating these rules under the authority of the Act is necessary to address these concerns.
Therefore, AMS makes no changes to the rule as proposed in response to these comments.
AMS rejects the commenter's view that it is beyond the authority of the Act for AMS to address prejudice based on categories, such as sexual orientation or gender identity, because the Congress that enacted the Act in 1921 would not have contemplated such protections. The Act specifically addressed “unjust discrimination” and “undue prejudice” and left it to the Secretary to set out the scope of equitable terms such as “unjust” and “undue,” as well as “unfair.”
Commenters cite several circuit court decisions that required a showing of harm to competition or a likely harm to competition establish a violation of sec. 202. These cases involved private claims and do not control the Agency's statutory authority to promulgate regulations. AMS is within its statutory authority to promulgate rules that “assure fair competition and fair-trade practices, to safeguard farmers and ranchers . . . to protect consumers . . . and to protect members of the livestock, meat, and poultry industries from unfair, deceptive, unjustly discriminatory and monopolistic practices. . . .” Congress granted the Secretary broad authority to determine the scope of coverage of terms such as “unjust discrimination” and “undue prejudice” or “unreasonable disadvantage” under secs. 202(a) and (b) of the Act.
This rule aims to prevent market exclusion of producers who have been subjected to unjust discrimination on a prohibited basis or based on engaging in a protected activity, and to snuff out those harms at their incipiency. Based on its knowledge of the industry, AMS has determined that undue and unreasonable prejudice and unjust discrimination on the prohibited bases and the protected activities identified in the rule amount to conduct that negatively effects these markets, and therefore AMS is establishing these regulations to address that conduct at its incipiency, when it occurs against a single individual.
Additionally, deceptive conduct violative of the Act has routinely been enforced on an individual basis absent a required showing of any particularized harm to competition since the very first administrative actions brought by the Department. Deceptive conduct often takes the form of unfair contract formation, enforcement, and termination and therefore most frequently occurs on an individual basis. To require a showing of harm to competition to prove deception violations under the Act would be contrary to longstanding enforcement standards and is adverse to the intent of the Act to protect farmers and ranchers from deception. Furthermore, the assertion from commenters that this rule will result in costly “baseless” litigation is contrary to the findings of AMS. AMS has determined that this rule will not increase litigation significantly due to the assertion by regulated entities, through their comments, that they do not engage in the conduct this rule aims to prohibit.
An agricultural advocacy organization contended the text, structure, and legislative history of the Act indicate that it prohibits discrimination based on market-vulnerable and protected-class status, giving AMS the legal authority to promulgate regulations based on this interpretation. The commenter argued the Act's prohibition of differential treatment on an “unjust,” “undue,” or “unreasonable” basis encompasses all forms of discrimination based on a producer's market vulnerability or protected classification because it includes all actions that adversely differentiate between producers without a legitimate basis. The commenter said that, in using such words in the Act, Congress clearly intended to invoke national values and policies related to fairness and equal treatment, including equal protection jurisprudence as it existed during enactment. According to the commenter, this jurisprudence was understood to prohibit essentially unjust or arbitrary discrimination between persons or corporations “in a similar situation or condition.”
The commenter next looked at secs. 202(a) and (b) of the Act in the context of the statutory scheme, contrasting their broad reach with the more limited scope of secs. 202(c) through (f), which specifically target business practices with anticompetitive effects, and arguing this difference implies Congress intended for these first two sections to apply more expansively. This commenter further claimed, if unfair, discriminatory, prejudicial, or deceptive conduct always required proof of market-wide competitive injury, these paragraphs would be superfluous because paragraph (e), which prohibits “any course of business” or “any act” for the purpose or with the effect of causing competitive injury, would always apply. The commenter said this broad interpretation of secs. 202(a) and (b) to include discrimination based on protected-class or market-vulnerable status easily advances the Act's statutory purpose of ensuring fair competition and trade practices in livestock markets, noting that this type of discrimination reduces output and prevents efficient resource allocation by restricting certain producers' ability to enter and participate in markets. The commenter also said legislators enacting the Act sought to broadly address imbalances between buyers and sellers of livestock, referring in detail to the Act's legislative history for evidence that Congress intended for it to have an expansive scope, including coverage of a wide range of unfair and unjust practices.
The commenter also argued that the prohibitions in secs. 202(a) and (b) do not merely include intentionally
The commenter further argued that AMS holds authority to interpret the meaning of sec. 202 and identify practices that violate its prohibitions. The commenter said Congress modeled USDA's role under the Act on that of the Federal Trade Commission under the FTC Act, envisioning an authority with broad jurisdiction and power. According to the commenter, Congress even went beyond the FTC Act model in one respect in its grant of authority to USDA, with sec. 407 of the Act giving USDA unequivocal authority to promulgate rules as needed to carry out its provisions. The commenter also said many court decisions have given strong deference to USDA determinations on whether a practice violates the Act, relying on reasoning that the facts of individual cases determine the meaning of the Act's operative terms, and that USDA is responsible for efficiently regulating market agencies and packers. Finally, the commenter argued “
One commenter recommended the following proposed regulatory text language to explicitly state violations of the proposed rule require no showing of competitive harm:
Where a regulated entity commits conduct prohibited by Subpart 201.302-201.306, such conduct violates §§ 202(a) and (b) of the Act whether or not market-wide harm to competition results. The unfair, unjustly discriminatory, or deceptive treatment of one covered producer, the giving to one covered producer of an undue or unreasonable preference or advantage, or the subjection of one covered producer to an undue or unreasonable prejudice or disadvantage in any respect violates the Act.
AMS acknowledges the commentors' comments around a showing of harm to competition. The meaning of competition or harm to competition must be broader than its meaning under the antitrust laws.
A cattle industry trade association said this provision also exceeds the scope of the Act because AMS's contention that deception does not
The Act does not require proof of a particularized intent to deceive.
This final rule prohibits regulated entities from engaging in deceptive practices. Regulated entities include packers, swine contractors, and live poultry dealers. The rule
Likewise, a meat industry trade association argued that Congress referred to issues relating to socially disadvantaged farmers and ranchers in other parts of the 2008 Farm Bill but failed to do so in the context of its direction for rulemaking under the Act; therefore, it is reasonable to assume Congress did not seek to address such topics under the Act.
Further, as noted earlier, Executive Order 14036 directs the Secretary to address unfair treatment of farmers and improve conditions of competition in their markets by considering rulemaking to address, among other things, certain market abuses and anticompetitive practices in the livestock, poultry, and related markets, including unjustly discriminatory, unduly prejudicial, and deceptive practices—in particular retaliation. This final rule is responsive to the Executive Order.
This rule's interpretations of unjust discrimination, undue and unreasonable prejudice, and retaliation are consistent with longstanding approaches to protecting producers under the Act, are consistent with interpretations of similar provisions of sec. 5 of the FTC Act and the ICA, and mirror congressional policy as reflected in ECOA. Moreover, Congress as recently as 2008 directed USDA to conduct rulemakings on sec. 202, which led to the 2020 Rule discussed above on undue preferences. The 2020 Rule wrestles with questions of undue prejudices which this final rule settles. Deception similarly follows a long line of cases and rules covering deceptive practices under the Act. Regarding issues raised by commenters around the major question doctrine, this rule does not address political matters, nor does it focus on fixing purely economic harms. This rule aims to increase protections for producers by clarifying that secs. 202 (a) and (b) of the Act prohibit discriminatory, retaliatory, and deceptive conduct by regulated entities.
A commenter said AMS aggravates these issues by inviting more anonymous feedback in its request for comment on the proposed rule, making it difficult to assess commenters' credibility, encouraging more false or unverifiable anecdotes, and further weakening the evidentiary foundation of the eventual final rule. The commenter urged AMS to reopen the comment period after clarifying that it will not give anonymous anecdotes disproportionate weight. Another commenter said, as AMS explicitly left racially discriminatory practices off its list of criteria for finding undue or unreasonable preferences under the Act in promulgating the final rule codified at 9 CFR 201.211,
The provisions in this rule are basic, fundamental protections against discrimination on prohibited bases as authorized by the Act and as consistent with congressional policy. The prohibition on retaliation protects the ability for producers to communicate with governmental entities, associate, cooperate, and compete. The prohibitions on deception are equally basic. These basic and fundamental provisions are justified with the record presented. Decades of complaints by producers, include public hearings with the Department of Justice, have catalogued how vertical integration and market concentration have left producers unable to avoid adverse treatment that tends to exclude them from the marketplace, including retaliation preventing them from even reporting these concerns to governmental authorities. The result has been producers unable to bargain effectively in the marketplace or fully obtain the benefits of their livestock production and poultry grow out services. Regulated entities consistently assert they do not engage in such practices; if so, then the burdens from adopting this rule are low.
AMS is not reopening the comment period for this rule. Consistent with the Administrative Procedure Act, all interested persons had an opportunity to comment and the agency has considered all relevant matter received through the public comment process.
AMS does not agree that it has reversed its position with respect to the rationale underpinning the rule promulgating § 201.211. This final rule addresses undue and unreasonable prejudices and disadvantages and unjust discrimination. Conversely, the rule implementing § 201.211 addressed undue and unreasonable preferences and advantages. AMS may return to the question of undue and unreasonable preferences and advantages in future rulemaking but does not have at this time any further information to offer with respect to how AMS would or would not apply the Act's prohibition on undue or unreasonable preferences or advantages. AMS is not making any further changes in response to this comment.
Recent research conducted by the USDA's Office of the Chief Economist and presented at the American Association for Agricultural Economics
Therefore, AMS will not make changes to the final rule in response to this comment.
Live poultry dealers and a poultry industry trade association said the proposed rule is unconstitutionally vague because it includes a number of poorly defined or undefined terms for which failure to comply would result in a regulatory violation. The commenters said it provides only examples of behavior that would constitute a prohibited “prejudice or disadvantage” or “retaliation,” rather than spelling out definitive lists or definitions that regulated entities can use to comply with the proposed rule. The commenters highlighted other terms raising vagueness issues, such as “generally or ordinarily offered,” “differential contract performance or enforcement,” and “tak[ing] an adverse action.” These commenters said the rule also fails to spell out other concepts essential for identifying unlawful conduct, such as what would constitute a prohibited pretext or a legitimate explanation, how the recordkeeping requirements would be triggered, or what records must be kept. Commenters emphasized clear definitions are critical for companies to know what is and is not allowed under the rule.
The terms used in this rule are intended to follow their plain language meaning, as applied to the livestock and poultry industries and within the legal framework regulating these industries. The following discussion demonstrates how these terms support the rule's prohibitions against undue prejudice, deception, and retaliation and in fact are quite specific.
“Retaliation” is set forth in paragraph (b)(3) and encompasses actions taken by regulated entities against covered producers such as contract termination, refusal to renew a contract, offering of more unfavorable contract terms than those generally or ordinarily offered, refusal to deal, interference with third-party contracts, and modification of contracts on less favorable terms than those previously enjoyed in response to the producer's participation in a protective activity. What constitutes retaliation is clearly defined in the rule, and likewise the rule clearly lays out protected activities against which retaliation is prohibited.
In this rule, “generally or ordinarily offered” terms are terms most producers would qualify for when contracting with a regulated entity. Whether terms are “generally or ordinarily offered” is an inquiry regarding specific facts and circumstances. Each case may vary by regulated entity and even for any given regulated entity may vary based on how the regulated entity would normally deal in the circumstances presented by the producer in question. However, “generally or ordinarily” does not apply to special contract terms that some regulated entities may use with certain producers, whether to receive particular quality attributes or services or for other reasons that are not discrimination on prohibited bases. The purpose of the rule is to ensure that a covered producer is not denied contract terms on the basis of a protected class that an “ordinary” similarly situated producer could receive from the regulated entity.
“Performing under or forcing a contract differently than with similarly situated producers” refers to situations where a regulated entity operates in such a way that it denies a grower the full benefits to which it is entitled under its contract with the regulated entity. A poultry grower may seek to enforce a production contract term that gives the grower the right to receive appropriate feed for the grower's flocks on a timely basis in the event the grower regularly or at critical times experiences insufficient, delayed, or inappropriate feed. If a regulated entity threatens to terminate a grower's contract in response to the grower's efforts to enforce a particular contract term (a protected activity), this retaliatory conduct would violate the Act. AMS notes that this violation would be separate from any violation of contract law that may also exist. Another example is selective information disclosures. These often take the form of a regulated entity withholding materially relevant information from one covered producer that the regulated entity generally or ordinarily provides to other covered producers. In these instances, information-deprived producers will have an incomplete picture of their business relationships with regulated entities, and therefore will operate at an unreasonable disadvantage relative to producers who receive the pertinent information.
“Tak[ing] an adverse action” encompasses a range of prejudicial, deceptive, or retaliatory actions that unjustly inhibit market access such as prejudice, disadvantage, retaliation, deception, or any action that inhibits market access to producers. A range of actions taken by producers on legitimate business grounds can be adverse to producer welfare. However, in the context of this rule, adverse actions are those actions taken by regulated entities against producers that either unfairly discriminate against producers on the basis of a protected class, deceive producers, or represent retaliation against producers for engaging in protected activities such as lawful communications, assertion of contract rights, associational participation, or participating as a witness in any proceeding under the Act.
Moreover, even where relevant, the meaning of competition or harm to competition must be broader than its meaning under the antitrust laws.
In accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35), 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 Office of Management and Budget (OMB) control number. This final rule includes a new collection of information contained in new § 201.304(c), “Recordkeeping of compliance practices.” The proposed rule requested comment on the estimated recordkeeping burden. All comments received on this information collection are summarized and included in the final request for OMB approval. Under the final rule, there are no new regulatory text changes that would change the proposed rule costs and benefits analyses. The burden estimates under the final rule are updated to reflect the most recent data available, updates in regulated entity wages, and the number of regulated entities. The estimated burden for the recordkeeping requirement imposed by this final rule is as follows:
AMS expects the recordkeeping costs will be comprised of the time required by regulated entities to store and maintain records they already keep. AMS expects that the costs will be relatively small because some packers, live poultry dealers, and swine contractors may currently have few records concerning policies and procedures, staff training materials, materials informing covered producers regarding reporting mechanisms and protections, compliance testing, board of directors' oversight materials, and the number and nature of complaints received related to unduly prejudicial and unjustly discriminatory treatment. Some firms might not have any records to store. Others already store the records and may have no new costs.
The amount of time required to keep records was estimated by AMS subject matter experts. These experts were auditors and supervisors with many years of experience in AMS's PSD conducting investigations and compliance reviews of regulated entities. AMS used the May 2022 U.S. Bureau of Labor Statistics (BLS) Occupational Employment and Wage Statistics for the time values in this analysis.
AMS expects that recordkeeping costs will be correlated with the size of the firms. AMS ranked packers, live poultry dealers, and swine contractors by size and grouped them into quartiles, estimating more recordkeeping time for the largest entities in the first quartile than for the smallest entities in the fourth quartile. The first quartile contains the largest 25 percent of entities, and the fourth quartile contains the smallest 25 percent of entities. AMS estimated that § 201.304(c) will require an average of 4.00 hours of administrative assistant time, 1.50 hours of time each from managers, attorneys, and information technology staff for packers, live poultry dealers, and swine contractors in the first quartile to setup and maintain the required records in the
AMS also expects that packers, live poultry dealers, and swine contractors will incur continuing recordkeeping costs in each successive year. AMS estimated that § 201.304(c) will require an average of 3.00 hours of administrative assistant time, 1.50 hours of time each from managers, attorneys, and 1.00 hour of time from information technology staff for packers, live poultry dealers, and swine contractors in the first quartile to setup and maintain the required records in each succeeding year. AMS expects that packers, live poultry dealers, and swine contractors in the second quartile will require an average of 1.50 hours of administrative assistant time, 0.75 hours of time each from managers, attorneys, and 0.50 hours of time from information technology staff in each succeeding year. The third quartile will require 1.00 hour of administrative assistant time, 0.50 hours of time each from managers, attorneys, and 0.33 hours of time from information technology staff in each succeeding year, and the fourth quartile will require 0.50 hours of administrative assistant time, 0.25 hours of time each from managers, and attorneys, and 0.17 hours from information technology staff.
Estimated first-year costs for recordkeeping requirements in § 201.304(c) totaled $30,000 for live poultry dealers,
Breaking out costs by market, AMS expects recordkeeping requirements in § 201.304(c) to cost beef packers $58,000 in the first year and $50,000 in each following year. Section 201.304(c) will cost lamb packers $23,000 in the first year and $20,000 in successive years. Section 201.304(c) will cost pork packers $42,000, and it will cost swine contractors $193,000 for a total of $235,000 in the first year. Section 201.304(c) will cost swine contractors $166,000 in successive years, and it will cost pork packers $36,000 for a total of $202,000 in successive years.
AMS prepared this assessment in compliance with the requirements of Executive Orders 12866, 13563, and 14094. 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 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 reaffirms, supplements, and updates Executive Order 12866 and further directs agencies to solicit and consider input from a wide range of affected and interested parties through a variety of means.
This rulemaking has been determined to be significant for the purposes of E.O. 12866 as amended by E.O. 14094 and, therefore, has been reviewed by OMB. As a required part of the regulatory process, AMS prepared an economic analysis of the costs and benefits of §§ 201.302, 201.304, 201.306, and 201.390.
This Regulatory Impact Analysis (RIA) presents an assessment of the anticipated benefits and costs from the rule including an assessment of regulatory alternatives: the
This regulatory filing is comprised of definitions in § 201.302, specific prohibited discriminatory and unduly prejudicial practices in § 201.304, specific prohibited deceptive practices in § 201.306, and a statement of severability among the provisions in § 201.390. The definitions in § 201.302 of a covered producer, livestock producer, and regulated entity will apply to §§ 201.304 and 201.306, and the regulatory impacts of the definitions are captured in the regulatory impacts of §§ 201.304 and 201.306, which are highlighted in this analysis.
The statement of severability in § 201.390 has no quantified regulatory impact, as it only serves to ensure that if any provision of §§ 201.302, 201.304, or 201.306 is declared invalid or the applicability to any person or circumstance is invalid, the remainder of the provisions will remain valid.
Under the final rule, there are no new regulatory text changes that would change the proposed rule costs and benefits of the regulatory analyses. The new information collection and recordkeeping requirements under the final rule are updated to reflect only the most recent data available, updates in regulated entity wages and number of regulated entities.
This section describes the need for the regulatory action, and how the regulatory action will meet this need. The structure of the livestock and poultry industries sets the stage for unjustly discriminatory and deceitful conduct by regulated entities. This rule aims to benefit covered producers by protecting their rights from these market harms. This regulatory action addresses market failure in the livestock and
The rise of concentration and vertical contracts in livestock and poultry markets has increasingly created an environment that enables packers, swine contractors, and live poultry dealers to unjustly exclude many producers from, and otherwise undermine their economic opportunities in, the marketplace. This adverse treatment is a cost, or economic harm, to covered producers born from market exclusion and associated high search costs of finding alternative markets in concentrated markets coordinated with vertical contracts.
Concentration in these markets has intensified over the past several decades and continues today. Concentration ratios are one metric to track the increasing share of slaughter of livestock and poultry in U.S. attributed to fewer packers and poultry integrators. Table 1 in the
The data in Table 1 are estimates of CR4s at the national level; however, in practice, the relevant economic markets for livestock and poultry may be regional or local, where concentration may be higher than those at the national level. This is because of limits on how far live animals can be safely and efficiently transported. In particular, regional concentration is often higher than national concentration for hogs.
Market concentration and the use of vertical contracts are interrelated; as such, growing, production, and marketing contracts feature prominently in the livestock and poultry industries. As outlined above, several provisions in §§ 201.304 and 201.306 will affect the process of contract formation, performance, termination, and any other action that a reasonable covered producer would find materially adverse for livestock, poultry, and meat grown or marketed.
The type of contracting varies among cattle, hogs, and poultry. Broilers, the largest segment of poultry, are almost exclusively grown under production contracts, in which the live poultry dealers, a regulated entity, own the birds and provide poultry growers with feed and medication to raise and care for the birds until they reach the desired market size. Poultry growers provide the housing, the skill and labor, water, electricity, fuel, and provide for waste removal. Fed cattle marketing contracts typically take the form of marketing agreements. Hog production falls between these two extremes.
As shown in Table 5 below, over 96 percent of all broilers and over 42 percent of all hogs are grown under contractual arrangements. Similar to poultry contracts, swine contractors typically own the slaughter hogs and sell the finished hogs to pork packers. The swine contractors typically provide feed and medication to the swine production contract growers who own the growing facilities and provide growing services. The following table shows that the percentage of contract growing arrangements by species has remained relatively stable between 2007 and 2017.
Other types
AMS reports the number of cattle sold to packers under formula, forward contract, and negotiated pricing mechanisms. Table 6 illustrates the prevalence of contracting in the marketing of fed cattle. Formula pricing methods and forward contracts are two forms of AMA contracts. Thus, the first two columns in the following table are cattle marketed under contract and the third column represents the spot market, or negotiated market, for fed cattle including negotiated grid. The data in the below table show that the AMA contracting of cattle has increased since 2010. Approximately 55 percent of fed cattle were marketed under contracts in 2010 (formula and forward contracts in the below table). By 2021, the percentage of fed cattle marketed to packers under AMA contracts had increased to just over 72 percent. These data also show the declines in the percentage of cattle sold on the spot market, or negotiated trades, from 46 in 2010 to 28 in 2021.
As previously
The livestock and poultry industries are characterized by a high volume of growing, production, and marketing contracts. When coupled with high levels of market concentration, this market environment can make it easier for regulated entities to engage in undue prejudice and unjust discrimination, retaliation, and deception and make the harms to producers greater from those abuses.
Despite various policy and public concerns, contracting, growing, production, and marketing contracts can offer certain benefits to the contracting parties. Properly tailored, benefits can include helping farmers, livestock producers, and processors manage price and production risks, elicit the production of products with specific quality attributes by tying prices to those attributes, and facilitate the smooth flow of commodities to processing plants. Such attributes may encourage certain efficiencies in use of farm and processing capacities. Quality-related attributes and standards can incentivize farmers to deliver products that consumers desire and produce products in ways that reduce processing costs.
There are, however, trade-offs with the use of these contracts. In concentrated industries, like the cattle, hog, and poultry industries, where market power is present, these types of contracts may result in increased opportunities for undue prejudices and unjust discrimination, retaliation, and deception, among other concerns, which cause inefficiencies in the markets for livestock, poultry, and meat.
Livestock and poultry contracts may lead to unjust, prejudicial, and retaliatory practices. For example, a contract that limits a poultry grower's services to a single integrator, even if the contract provides for fair compensation to the grower, still leaves the grower subject to risks. The grower faces the risk that the contractor may require additional capital investments or the contractor may impose lower returns at the time of contract renewal—leveraging its market power given the grower's limited options.
In the poultry industry, limited integrator choice may accentuate contract risks. The data in Table 2 above show that 52 percent of broiler growers, who account for 56 percent of total production, report having only one or two integrators in their local areas. Even where multiple integrators are present, there are high costs to switching, owing to the differences in technical specifications that integrators require. The growers likely need to invest in new equipment and learn to apply different operational techniques due to different breeds, target weights, and grow-out cycles.
A 2006 survey indicated that growers with access to a single integrator received seven to eight percent less
In 2013, production contracts covered $58 billion in agricultural production, 83 percent of which was poultry and hog contracts.
In the cattle sector, cow-calf operations incur a significant investment in breeding stock and typically sell steers and heifers once a year. Access to competitive markets, absent from unjust discrimination, undue prejudice, and retaliation, is important to the economic livelihood of the market. Reduced marketing options—fewer options to sell on the spot market, or lack of access to contracts—can leave producers susceptible to unfair trade practices. Spot market trades, or negotiated trades, as opposed to marketing agreements or contracts, for fed cattle accounted for 51 percent of all trades in 2008 and fell to 29 percent in 2022.
One indication of potential market power is industry concentration.
The levels of industry concentration shown in Tables 1 and 2 may contribute to oligopolistic market power and asymmetric information. The result is that the contracts bargained between the parties may leave livestock producers, swine production contract growers, and poultry growers vulnerable to anticompetitive conduct such as undue prejudice and unjust discrimination, retaliation, and deception.
There is asymmetry in the information available to livestock producers and livestock and poultry growers as compared to the packers, swine contractors, and live poultry dealers with whom they contract. The larger packers, swine contractors, and live poultry dealers generally have more information (costs of production, input quality, and consumer demand, for example) that is useful in contracting than the smaller livestock producers and livestock and poultry growers. This asymmetry of information can lead to deceptive practices by regulated entities with superior information in contract formation, performance, termination, or refusal by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading. A 2023 AMS rule, Transparency in Poultry Grower Contracting and Tournaments, directly aims to address this asymmetric information in the poultry industry by adding disclosures and information that live poultry dealers engaged in the production of broilers must furnish to poultry growers with whom dealers make poultry growing arrangements.
Some marketing contracts for fed cattle, for example, use various plant averages in the calculation for the base price of the cattle in the marketing contract. Only the packer has the information about the plant averages and producers cannot independently verify the information. Similar issues exist in hog marketing contracts. For contracts based on the pork cutout, the hog packer has more information about the direct retail pork demand and hence pork cutout prices than hog sellers.
Live poultry dealers hold information on how individual poultry growers perform under a variety of contracts. The average number of contracts for the live poultry dealers filing annual reports with AMS in 2020 was 251. The largest live poultry dealers contracted with several thousand growers.
Most growers producing poultry under production contracts are paid under a poultry grower ranking or “tournament” pay system. Under tournament systems, the contract between the poultry grower and the company for whom the grower raises poultry for slaughter pays the grower based on a grouping, ranking, or comparison of poultry growers delivering poultry to the same company during a specified period. Generally, live poultry dealers provide most of the inputs to all the growers in each poultry tournament used to determine grower pay. In these tournaments, the live poultry dealers have information about the quality of the inputs, while each grower only knows what he or she can observe. A grower may not be able to evaluate the inputs it received such as chicks and feed, and he or she almost certainly will not know about the inputs received by other growers. A live poultry dealer also has historical information concerning growers' production and income under many
Hold-up is another problem that is particularly acute in service contracts between poultry growers and live poultry dealers. The economic concept of a hold-up problem refers to a situation in which two parties may be unable to cooperate efficiently due to incomplete or asymmetric information and the inability to write, enforce, or commit to contracts. Once a party becomes locked into a transaction, especially as a result of making a transaction-specific investment, they become vulnerable to exploitation by the other party. This may involve one party to a contract opportunistically deviating from expectations of the other party or failing to live up to previously agreed upon terms.
In the poultry industry, hold-up occurs when a poultry grower makes an investment, such as in poultry housing, and becomes dependent upon the growing arrangement to repay the investment. Hold-up is less common for hog and cattle producers, so the discussion here is limited to poultry growing to highlight this risk to poultry growers. Substantial gaps exist between the periods of time covered by the contract and the mortgage on poultry housing, creating uncertainty around whether growers will be able to repay their debt and recoup their investments, introducing the potential for hold-up into the contracting process. If the integrator takes advantage of the grower's dependence, for example, by delaying delivery of chicks that the grower depends upon to make payments on investments, it would be holding up the grower. The aim of the economic hold-up may be to coerce the grower into accepting conditions that benefit the integrator at the expense of the grower. For example, refusing to supply chicks until a contract amendment with unfavorable conditions is signed.
This is of concern in poultry production contracts because the capital investment requirements related to growing chickens are significant and highly specialized (that is, they have little value outside of growing chickens). As a result, growers entering the market are tied to growing chickens to pay off the financing of the capital investment. Growers have reported that they must accept unfavorable contract terms or endure unfavorable treatment during a contract—including inappropriate limits on their ability to form associations, assert their rights under the law or contract (such as viewing the weighing of broilers), communicate with government entities, and seek alternative business relationships—because they are tied to production to pay off lenders and they have few, if any, alternative integrators with whom they can contract. Hog producers, which invest heavily in production facilities, may face similar risks.
Long term, this behavior may result in underinvestment in production, which is inefficient. Alternatively, if growers make a significant investment because they do not anticipate hold-up, but then it does occur, then growers may be required to spend too much on investments. The resulting over-investment in capital by those growers facing hold-up is also inefficient. The hold-up problem is a manifestation of both market power and asymmetric information.
As described previously, the organization and structure of poultry and livestock markets is characterized by regional market power; substantial investment in production capital that is specific to a single production purpose; and, in the poultry industry, nearly universal use of production contracts, and widespread use of marketing contracts in the cattle industry, while less so, for hogs. These conditions create the potential for market failures. Asymmetric information and imperfect competition are concerns in livestock and poultry markets. economically incomplete contracts and hold-up are of particular concern in poultry markets and can exacerbate the risk of undue prejudice and unjust discrimination, retaliation, and deception in poultry and livestock markets.
By setting forth specific prohibitions on unduly prejudicial and unjustly discriminatory and deceptive practices, the rule will reinforce producers' existing rights to gather and share information, while reducing the fear of retaliation and interference in the contracting process. The prohibitions in the rule will also continue to support, and possibly promote more efficient and equitable information access, reduce the hold-up problem, reduce retaliation, discourage false and misleading statements, and increase communication, cooperation, and retention of legal rights. The prohibitions specified in §§ 201.304 and 201.306 will ultimately assist in mitigating the impacts of imperfect competition.
Executive Order 12866 requires an assessment of costs and benefits of potentially effective and reasonably feasible alternatives to the planned regulations and an explanation of why the planned regulatory action is preferable to the potential alternatives.
If §§ 201.304 and 201.306 are never promulgated, there are no marginal costs and marginal benefits as industry participants will not alter their conduct. From a cost standpoint, this
As discussed above, final § 201.304 prohibits undue prejudice, unjust discrimination, and retaliation by regulated entities and adds a requirement for regulated entities to maintain records that they already keep, for up to a period of five years, related to its compliance with final § 201.304. Section 201.306 will prohibit deceptive practices by regulated entities in contract formation, performance, or termination by employing a false or misleading statement, or omission of material information necessary to make a statement not false or misleading. Additionally, a regulated entity may not refuse a contract by providing false or misleading information to a covered producer or associations of covered producers.
Reductions in prejudicial, discriminatory, retaliatory, and deceptive practices by packers, swine contractors, and live poultry dealers will benefit society. These types of conduct are inefficient, and often difficult to quantify for prejudicial, discriminatory, retaliatory, and deceptive practices are not necessarily written into contracts but in contract offers, preparation and enforcement. Production contracts need not change to realize benefits in this rule. The amount of benefits that depends on the extent to which the rule reduces prejudicial, discriminatory, retaliatory, and deceptive practices. That, in turn, is bounded by the degree to which any of these types of activities are occurring in the baseline. If the reductions are small, the benefits will be small. The greater the reductions, the greater the potential benefits. USDA's long-standing policy has been that the Act prohibits the type of conduct that final §§ 201.304 and 201.306 addresses.
Final §§ 201.304 and 201.306 add specificity to what constitutes undue prejudices, unjustly discriminatory practices, retaliation, and deception. The size of the benefits is difficult to quantify as it depends on the amount of undue prejudice, unjust discrimination and deception that will be avoided due to added specificity provided by the rule. The added benefits to the industry from final §§ 201.304 and 201.306 over the
A key purpose of specifying certain prohibitions on unduly prejudicial, discriminatory, and deceptive practices, including those in final §§ 201.304 and 201.306, is to protect livestock producers, swine contractors and poultry growers' rights under the Act. Final §§ 201.304 and 201.306 will also help protect producers from unfair and deceptive practices stemming from market power imbalances such as undue prejudice, unjust discrimination, retaliation, and deception by using false or misleading statements in contracting by packers and live poultry dealers. The benefits of prohibiting prejudicial, discriminatory, and deceptive practices, will accrue not only to the market's covered producers and cooperative producers who have been subjected to the prohibited practices, but also to those for whom the rule's deterrence effects will protect from future potential abuses.
Several provisions in the final rule will enhance the protection of the rights of producers to lawfully communicate and to associate with others to explore business relationships and improve production practices and in the marketing of livestock, poultry, and meat. These provisions will benefit producers by encouraging the use of their currently existing legal rights that will solidify and enhance their access to information. This in turn will help address information asymmetry and thus help producers make better business decisions, enhance their competitiveness, reduce the hold-up problem, and promote innovation and economic efficiency in the industry.
The final rule will help close this information gap by protecting the rights of producers to form associations and communicate freely with one another, and to communicate with other regulated entities for the purpose of exploring a business relationship. This will benefit producers by improving their ability to strengthen the returns to their livestock and poultry investments, by enhancing the bargaining power of supplier groups if they elect to organize in such a way.
This rule will prohibit retaliation against covered producers due to their communicating, negotiating, or contracting with other covered producers, a commercial entity, consultant, or regulated entities, which could increase the important decision-making information available to producers. Improved safeguarding of protected activities may enable the producer to improve business decision-making and manage risk, including potentially acquiring external insurance and risk-management products. In addition, facilitating producers' ability to gain more and better information will help correct information asymmetry and improve transparency and completeness in contracts.
More information will also reduce the risks associated with hold-up as discussed above. By protecting rights to freely communicate and associate, this rule will facilitate communication across the industry that may help disseminate information regarding new innovations and best practices within the industry. These types of provisions that could provide producers with access to more and better information should promote innovation and economic efficiency in the industry.
The final rule may also serve to reduce the risk of violating sec. 202(a) of the Act because it will provide clarification to the livestock, and poultry industries as to the discriminatory and deceptive practices that will be prohibited under that section of the Act. Less risk through the clarification provided in the final rule will likely foster fairness in contracting by providing explicit protections for livestock producers, swine production contract growers, and poultry growers.
Final § 201.306 specifies prohibited practices that will be considered deceptive, and thus in violation of sec. 202(a) of the Act. Though USDA already protects producers from deceptive practices, the rule will explicitly protect suppliers from deception by packers and live poultry dealers by employing a false and misleading statement, or omission of material information necessary to make a statement not false or misleading in contracting. Prohibited deceptions, including false statements or omissions, can prevent or mislead producers, sellers, or buyers from making informed decisions and thus
While some of these protections already benefit individual producers, ensuring they cover the full marketplace and can be enforced individually adds to the integrity and fairness of livestock and poultry contracting. Specifying these protections may bring additional benefits above the
Production and marketing contracting has many benefits in the livestock and poultry industries. The final rule can further enhance the documented benefits of contracting by prohibiting unduly prejudicial, discriminatory, and deceptive practices. Livestock producers often have few choices of packers to which they sell, and poultry growers often have few choices in the live poultry dealers for which they raise poultry. The limited alternatives cause fear among producers that certain actions they might undertake, such as communication with government or other regulated entities to pursue business relationships, association with certain groups, or making lawful public complaints about the packers, swine contractors, or live poultry dealers might result in harmful retaliations. AMS intends the final rule to promote integrity to the marketplace by enhancing the protection of the rights of the producers and alleviating those fears.
The literature and data on these topics are not sufficient to allow AMS to estimate the magnitude of the inefficiencies that the final rule may correct above the
The final rule will not impose any restrictions on numbers or types of production or marketing contracts that can be utilized, use of AMAs, poultry tournaments, or base price mechanisms in contracts for packers, swine contractors, and live poultry dealers. Instead, the final rule clarifies the prohibited unduly prejudicial, unjustly discriminatory, and deceptive practices that AMS considers violations of sections 202(a) and (b) of the Act. The final rule will require packers, live poultry dealers, and swine contractors to discontinue any prejudicial, unjustly discriminatory, or deceptive practices, if any are occurring. The practices prohibited by §§ 201.304 and 201.306 are the kind of practices that do not benefit society as a whole, but there is uncertainty about the extent of net costs to regulated entities of preventing them since they are based on behaviors and are not expressly written into contracts. In other words, §§ 201.304 and 201.306 result in uncertain-in-magnitude indirect costs resulting from adjustments by the livestock and poultry industries to reduce their use of AMAs, poultry tournaments, and pricing mechanisms, with the possibility of a number of changes to existing marketing or production contracts.
Though the magnitude of indirect costs is uncertain, AMS has constructed a scenario that indicates the magnitude is likely below an established dollar value benchmark. The following scenario illustrates why it is extremely unlikely that the rule's indirect costs will exceed the Unfunded Mandates Reform Act's (UMRA) cost compliance threshold of $170 million annually, a benchmark used to assess this rule's effects on the private sector.
AMS expects §§ 201.304 and 201.306 to reduce litigation costs due to increased compliance with the rule associated with the clarity provided by the rule as to the conduct that violates the Act, but also to increase litigation as this rule allows producers to find relief in courts. AMS is uncertain as to which of these offsetting effects will dominate and to what extent. The final rule clarifies the prohibited unduly prejudicial, discriminatory, and deceptive practices that will violate section 202(a) of the Act. The clarification could result in a reduction in litigation costs if companies come
However, there are several provisions in § 201.304 that could result in additional litigation. AMS has received formal and informal complaints against packers, swine contractors, and live poultry dealers for retaliation for belonging to various producer and grower associations, contacting AMS to file a complaint, asserting legal rights, and contacting a competing regulated entity to pursue a contractual relationship. Similarly, there are several provisions in § 201.306 that could result in additional litigation, including refusals by regulated entities to enter into or renegotiate contracts and contract terminations by producers. The clarity of the practices that AMS considers to be discriminatory and deceptive in §§ 201.304 and 201.306 could offer producers new hope for relief from courts for undue prejudicial, discriminatory, and deceptive practices by regulated entities. This effect could result in increased litigation.
As stated above, AMS is uncertain as to which effect will dominate and to what extent. AMS does not estimate litigation costs in this analysis.
AMS expects §§ 201.304 and 201.306 will result in direct administrative and recordkeeping costs to the industry. AMS expects that packers, swine contractors, and live poultry dealers will incur direct administrative costs of learning the rule and then reviewing and, if necessary, revising marketing and production contracts to ensure compliance with §§ 201.304 and 201.306. Regulated entities will also incur recordkeeping costs from keeping the records they already maintain for up to five years as required under § 201.304. The expected total costs of §§ 201.304 and 201.306 will be the direct administrative costs and recordkeeping costs of that regulatory alternative. The direct administrative costs and recordkeeping costs will be estimated below.
AMS expects that §§ 201.304 and 201.306 will prompt packers, live poultry dealers, and swine contractors to first review and learn the rule and then review their procurement policies and production contracts and make any necessary changes to ensure compliance with the new regulations. Expected costs are estimated as the total value of the time required to review and learn the rule and then review and, if necessary, revise procurement and production contracts.
AMS expects the direct administrative costs of complying with §§ 201.304 and 201.306 will be relatively small.
The certain types of benefits outlined above will be in proportion to the extent to which the rule reduces prejudicial, discriminatory, retaliatory, and deceptive practices. The USDA policy has long held that several of the provisions in §§ 201.304 and 201.306 or similar provisions were violations of the Act, although the position has not been established in regulations. Consequently, AMS expects packers, live poultry dealers, and swine contractors to make changes to relatively few contracts.
The direct costs of the rule are low because the discriminatory, retaliatory, and deceptive behavior which the rule seeks to mitigate are not overtly written into the terms of the contracts between regulated entities and producers. They are behaviors or conduct in which some regulated entities engage, for example by not offering contracts to some producers due to discrimination and retaliation or by offering less favorable contract terms due to discrimination, retaliation, and deception. If the rule results in less discriminatory, retaliatory, or deceptive behavior by regulated entities, the costs of offering a contract to a producer or grower that was previously denied a contract or amending the terms of a less favorable contract to an impacted producer or grower will be of uncertain. Given that the behavior that the rule seeks to mitigate is not overtly written into contracts and is behavior during the contract offering process, the potential costs of mitigating the behavior are uncertain. The more that discriminatory, retaliatory, and deceptive behavior is mitigated because of the rule, the greater the benefits. AMS does not expect any changes in types of production and marketing contracts offered. AMS expects the same types of contracts to be offered, but with more equitable performance under the contracts by regulated entities across producers, fewer producers denied or terminated from contracts, and better clarity regarding contractual expectations. AMS also expects more contracts to be offered to producers who may not previously have been offered a contract due to discrimination, for example. Given its professional expertise based on regulating the industry and investigating complaints of the prohibited behaviors, AMS does not believe that the discriminatory, retaliatory, and deceptive behavior addressed by this rule is written into contract terms frequently enough to warrant changes to very many contracts.
Although the amount of indirect costs is uncertain, AMS expects any indirect costs will likely range from marginal to modest. As shown above, AMS acknowledges that some regulated entities may offer higher prices to some livestock producers and growers when they come into compliance with this rule. This could shift livestock and poultry prices offered to some producers and growers toward the true value of their livestock or poultry that would prevail in a more competitive market and away from the artificially low prices offered through the abuse of market power by engaging in deception, discrimination, or retaliation. This would reduce the cost to society due to the market inefficiency (dead weight loss) created by discriminatory, retaliatory, and deceptive practices by some regulated entities. This shift in prices offered to some producers and growers toward their true value would result, in some instances, in a transfer of excess profits (profits that exceed those that would be earned in a more competitive market) from regulated entities to some growers and producers. This transfer from regulated entities to some producers and growers could occur. AMS cannot quantify the extent to which the behavior this rule aims to prohibit occurs in the industry or the extent of any harm that would be avoided by regulated entities' cessation of the behavior under the clearer limitations set by this rule. AMS notes that regulated entities, in their comments to the proposed rule, asserted that the occurrence of the practices addressed in the rule are not widespread. Assuming this is true, the indirect costs will be marginal. AMS, however, has noted the behaviors have been sufficiently widespread to warrant the intervention provided by this final rule.
Estimates of the amount of time required to review and learn the rule and to review and revise contracts and keep records were provided by AMS subject matter experts. These experts were auditors and supervisors with many years of experience in AMS's PSD conducting investigations and compliance reviews of regulated entities. In May 2022, BLS released
AMS expects that each packer, swine contractor, and live poultry dealer will spend one hour of legal time and one hour of management time to review and learn the rule and then, if necessary, revise production and marketing contracts to ensure compliance with the rule.
Live poultry dealers are currently required to file form PSD 3002, “Annual Report of Live Poultry Dealers,” OMB control number 0581-0308, with AMS. Ninety live poultry dealers filed annual reports with AMS for their 2021 fiscal year.
Packers are currently required to file form PSD 3004, “Annual Report of Packers” OMB control number 0581-0308, with AMS. Among other things, each packer reports the number of head of cattle or calves, hogs, and lamb, sheep, or goats that it processed. Three hundred sixty-five packers that processed cattle or calves, hogs, or lamb, sheep or goats filed reports or were due to file a report with AMS for their fiscal year 2021. Two hundred sixty-one were beef or veal packers. One hundred ninety-six were pork packers, and 139 were lamb, sheep, or goat packers.
AMS expects that packers processing more than one species of livestock will not incur additional costs for each species. That is, AMS expects that each packer will require one hour of attorney's time and one hour of management time regardless of how many species of livestock it processes. To allocate costs across (1) beef, (2) pork, and (3) lamb processors, AMS allocated one-third of the costs to each of (1) beef, (2) pork, and (3) lamb for packers that processed all three species. For packers processing any two, AMS allocated one half the costs to each.
AMS estimated that all live poultry dealers that are regulated under the final rule will require one hour of an attorney's time costing the industry $13,000
AMS expects that packers will require an estimated one hour of an attorney's time and one hour of management time costing the industry $85,000. AMS estimates the total costs will be $40,000 for beef packers and $16,000 for lamb packers to learn and review the rule and adjust contracts.
Costs to comply with the recordkeeping requirements are likely relatively low. Section 201.304(c) requires specific records that, if the regulated entity maintains, should be kept for a period of five years, including policies and procedures, staff training materials, materials informing covered producers regarding reporting mechanisms and protections, compliance testing, board of directors' oversight materials, and any records of the number and nature of unduly prejudicial or unjustly discriminatory-based complaints received.
Costs of recordkeeping include regulated entities maintaining and updating compliance records and are considered a direct cost. Some smaller regulated entities that currently don't maintain records may voluntarily decide to develop formal policies, procedures, training, etc. to comply with the rule and will then have records to maintain.
AMS expects the recordkeeping costs will comprise the time required by regulated entities to store and maintain records they already keep. AMS expects that the costs will be relatively small because many packers, live poultry dealers, and swine contractors may currently have few records concerning policies and procedures, staff training materials, materials informing covered producers regarding reporting mechanisms and protections, compliance testing, and board of directors' oversight materials related to prejudicial treatment. Some smaller firms might not have any records to store. Others already store the records and may have no new costs.
AMS estimated that recordkeeping time for larger entities will be greater than for smaller entities, and thus estimated costs by quartiles, from largest entities to smallest. AMS estimated that § 201.304(c) will require packers, live poultry dealers, and swine contractors in each quartile an average 4.00 hours, 2.00 hours, 1.33 hours, and 0.67 hours of administrative time for the first, second, third, and fourth quartiles, respectively. Additionally, AMS estimated that the hours required of managers, attorneys, and information technology staff each will average 1.50 hours, 0.75 hours, 0.50 hours, and 0.25 hours for the first, second, third, and fourth quartiles, respectively.
AMS also expects that packers, live poultry dealers, and swine contractors will incur continuing recordkeeping costs in each successive year. AMS estimated that § 201.304(c) will require an average of 3.00 hours, 1.50 hours, 1.00 hour, and 0.50 hour of administrative assistant time; 1.50 hours, 0.75 hour, 0.50 hour, and 0.25 hour of time each from managers and attorneys; and 1.00 hour, 0.50 hour, 0.33 hour, and 0.17 hour of time from information technology staff for packers, live poultry dealers, and swine contractors in the first, second, third, and fourth quartiles, respectively, to setup and maintain the required records in each succeeding year.
Estimated first-year costs for recordkeeping requirements in § 201.304(c) totaled $30,000 for live poultry dealers,
Breaking out costs by market, AMS expects recordkeeping requirements in § 201.304(c) to cost beef packers $58,000 in the first year and $50,000 in each following year. Section 201.304(c) will cost lamb packers $23,000 in the first year and $20,000 in successive years. Section 201.304(c) will cost pork packers $42,000, and it will cost swine contractors $193,000 for a total of $235,000 in the first year. Section 201.304(c) will cost swine contractors $166,000 in successive years, and it will cost pork packers $36,000 for a total $202,000.
Table 8 below summarizes combined expected administrative and recordkeeping costs for regulated entities in the first year and in succeeding years. AMS expects that administrative and recordkeeping costs associated with §§ 201.304 and 201.306 will cost each packer, swine contractor, and live poultry dealer an average $569 in the first year and an average $289 in each succeeding year. First-year costs will total $51,000 for live poultry dealers, $327,000 for swine contractors, and $208,000 for packers. Costs in successive years will be due to recordkeeping requirements and will total $26,000 for live poultry dealers, $166,000 for swine contractors, and $105,000 for packers annually.
The total direct administrative and recordkeeping costs are estimated to be $586,000 in the first year. Estimated first year total direct administrative and recordkeeping costs for the cattle and beef industry, hogs and pork, lamb, and poultry industries rounded to the nearest thousand dollars are listed in the following table.
Expected administrative and recordkeeping costs of §§ 201.304 and 201.306 for each year from 2023 through 2032 appear in the table below. Based on the analysis, AMS expects the ten-year total direct administrative and recordkeeping costs of §§ 201.304 and 201.306 to be $3.3 million.
Costs to be incurred in the future are lower than the same costs to be incurred today. This is because the money that will be used to pay the costs in the future can be invested today and earn a return on investment until the period in which the cost is incurred. After the cost has been incurred, the earned returns will still be available.
To account for the time value of money, the administrative costs to be incurred in the future are discounted back to today's dollars using a discount rate. The sum of all costs discounted back to the present is called the present value (PV) of total costs. AMS relied on both a three percent and seven percent discount rate as discussed in Circular A-4.
AMS calculated the PV of the ten-year total direct administrative and recordkeeping costs of the regulations using a three percent and seven percent discount rate. The PVs appear in Table 11.
AMS expects the PV of the ten-year total administrative and recordkeeping costs of §§ 201.304 and 201.306 to be $2.8 million at a three percent discount rate and $2.4 million at a seven percent discount rate.
AMS then annualized the PV of the ten-year total administrative and recordkeeping costs (referred to as annualized costs) of §§ 201.304 and 201.306 using both a three percent and seven percent discount rate as required by Circular A-4 and the results appear in Table 12.
AMS expects the annualized ten-year administrative and recordkeeping costs of final §§ 201.304 and 201.306 to be $331,000 at a three percent discount rate and $336,000 at a seven percent discount rate.
The expected costs of this rule are very small relative to the size of the industry; and expected benefits are expected to be proportional to reductions in conduct this rule addresses. Combined sales of beef, pork, and broiler chicken in the U.S. for 2022 were approximately $294.5 billion.
The third regulatory alternative that AMS considered is issuing §§ 201.304 and 201.306, but exempting small businesses, as defined by the SBA, from compliance with the recordkeeping requirement of § 201.304(c).
Table 13 summarizes combined expected administrative and recordkeeping costs for regulated entities in the first year and in succeeding years. AMS expects that administrative and recordkeeping costs associated with a small business exemption alternative will cost each live poultry dealer, swine contractor, and packer an average of $448, $548, and $265, respectively, in the first year. AMS expects costs to average $185, $271, and $27 for live poultry dealers, swine contractors, and packers, respectively, in each succeeding year. First-year costs will total $40,000 for live poultry dealers, $315,000 for swine contractors, and $97,000 for packers.
As discussed above, AMS considers the total costs from §§ 201.304 and 201.306 to be increased direct administrative and recordkeeping costs with no indirect costs from adjustments by the cattle, hog, and poultry industries to reduce their use of AMAs, change to pricing mechanisms or poultry tournaments, and no substantial changes to existing marketing, or growing or production contracts. AMS estimated the costs to small business from the direct administrative costs of §§ 201.304 and 201.306 but excluded the recordkeeping costs of § 201.304(c) in this alternative option.
AMS estimated the costs to small business to be the value of the time for management, attorneys, administrative staff, and information technology staff to review the rule and the firms' practices determining compliance with the direct administrative costs of §§ 201.304 and 201.306. AMS estimated costs for the Small Business Exemption Alternative similarly to the final rule. The only difference is the recordkeeping costs of § 201.304(c) attributable to small business are not included in the costs for the Small Business Exemption Alternative. The estimates appear in Table 14. Costs for the final rule are also shown for convenience.
AMS estimates that §§ 201.304 and 201.306, with the small business exemption, will result in $427,000 in direct total costs in the cattle, hog, lamb, and poultry industries in the first full year following implementation and $182,000 each year in ongoing costs. AMS expects the ten-year total costs of § 201.304 and 201.306 with a small business exemption to be $2.1 million. Exempting small business will save approximately $159,000 in the first year and $1.1 million over ten years.
AMS calculated the PV of the ten-year total costs of the Small Business Exemption Alternative using both a three percent and seven percent discount rate and the PVs appear in the following table. Costs for the final rule are also shown for convenience.
AMS expects the PV of the ten-year total costs of §§ 201.304 and 201.306 with a small business exemption to be $1.8 million at a three percent discount rate and $1.5 million at a seven percent discount rate.
AMS then annualized the PV of the ten-year total costs of §§ 201.304 and 201.306 with a small business exemption using both a three percent and seven percent discount rate and the results appear in Table 16. The final rule is also shown for convenience.
AMS expects the annualized costs of §§ 201.304 and 201.306 with a small business exemption to be $210,000 at a three percent discount rate and $215,000 at a seven percent discount rate.
The status quo alternative has zero marginal costs. AMS compared the annualized costs of the final rule to the annualized costs of the Small Business Exemption Alternative by subtracting the annualized costs of the Small Business Exemption Alternative from those of the final rule and the results appear in Table 17.
The annualized costs of the Small Business Exemption Alternative are $121,000 less expensive using a three percent discount rate and $121,000 less expensive using a seven percent discount rate. As is the case with costs, the benefits will be highest for the final rule because the full benefits will be received by all livestock producers and poultry growers, not just those doing business with large packers, swine contractors and live poultry dealers.
Though the Small Business Exemption Alternative will save approximately $121,000 on an annualized basis, AMS chose final §§ 201.304 and 201.306 over the Small Business Exemption Alternative because AMS wishes to prevent broadly the kind of undue prejudices and unjust discrimination described in the rule. AMS believes that keeping relevant records will help promote compliance with this rule, that all packers, live poultry dealers, and swine contractors cannot purchase livestock or enter into contracts for growing services with the kind of undue prejudices and unjust discrimination described in the rule.
AMS considered all three regulatory alternatives and believes that the final rule is the best alternative, as it benefits all livestock producers, swine production contract growers, and poultry growers, regardless of the size of the packer, swine contractor, or live poultry dealer with which they contract above the
As part of the regulatory process, a Regulatory Flexibility Analysis (RFA) is conducted in order to evaluate the effects of this rule on small businesses. Under the final rule, there are no new regulatory text changes that would change the proposed rule costs and benefits of the regulatory analyses.
The SBA defines small businesses by their North American Industry Classification System Codes (NAICS).
AMS maintains data on live poultry dealers from the annual reports these firms file with AMS. Currently, 90 live poultry dealers will be subject to the regulation. Fifty-five of the live poultry dealers will be small businesses according to the SBA standard.
AMS records identified 365 packers that file annual reports or are due to file with PSD for their 2021 fiscal year. Two hundred sixty-one were beef packers. One hundred ninety-six were pork packers, and 139 were lamb or goat packers. Many firms slaughtered more than one species of livestock. For instance, 112 packers slaughtered both beef and pork.
Most packers will be small businesses, although large packers are responsible for most meat production. Three hundred forty-eight packers will be small businesses. Two hundred fifty-three beef packers and 183 pork packers were small businesses. All 139 lamb and goat packers were small businesses.
AMS does not have similar records for swine contractors because they are not required to register with AMS or provide annual reports. Table 24 of the 2017 USDA Census of Agriculture indicated that there were 575 swine contractors in 2017. The Census of Agriculture table has categories for the number of head that swine contractors sold, but not the value of the head sold. AMS expects that the 467 swine contractors that sold 5,000 head of hogs or more were large businesses, and the 108 contractors that sold less than 5,000 head were small businesses.
AMS estimated the costs in two parts. First, AMS expects that each packer, swine contractor, and live poultry dealer will review and learn the new rule and, if necessary, revise production and marketing contracts to ensure compliance with the new rule. Second, AMS expects that packers, live poultry dealers, and swine contractors will have additional costs associated with the new recordkeeping requirements in § 201.304(c).
AMS estimated that costs for reviewing and learning the final rule to small live poultry dealers, small packers, and small swine contractors will consist of one hour of a manager's time and one hour of a lawyer's time to review the requirements of §§ 201.304 and 201.306. Expected first-year costs will be $234
Concerning the recordkeeping requirements in final § 201.304(c), AMS expects the cost will be comprised of the time required to store and maintain records already kept. AMS expects that the costs will be relatively small
AMS expects that recordkeeping costs will be correlated with the size of the firms. AMS ranked packers, live poultry dealers, and swine contractors by size and grouped them into quartiles, estimating more recordkeeping time for larger entities than for the smaller entities. AMS estimated that § 201.304(c) will require an average of 4.00 hours of administrative assistant time, 1.50 hours of time each from managers, attorneys, and information technology staff for packers, live poultry dealers, and swine contractors in the first quartile, containing the largest entities, to setup and maintain the required records in the first year. AMS expects the packers, live poultry dealers, and swine contractors in the second quartile will require an average of 2.00 hours of administrative assistant time, 0.75 hours of time each from managers, attorneys, and information technology staff for first year costs. The third quartile will require 1.33 hours of administrative assistant time, 0.50 hours of time each from managers, attorneys, and information technology staff for first year costs, and the fourth quartile, containing the smallest entities, will require 0.67 hours of administrative assistant time, 0.25 hours of time each from managers, attorneys, and information technology staff.
AMS also expects that packers, live poultry dealers, and swine contractors will incur continuing costs in each successive year. AMS estimated that § 201.304(c) will require an average of 3.00 hours of administrative assistant time, 1.50 hours of time each from managers and attorneys, and 1.00 hour of time from information technology staff for packers, live poultry dealers, and swine contractors in the first quartile to setup and maintain the required records in each succeeding year. AMS expects the packers, live poultry dealers, and swine contractors in the second quartile will require an average of 1.50 hours of administrative assistant time, 0.75 hours of time each from managers and attorneys, and 0.50 hours of time from information technology staff in each succeeding year. The third quartile will require 1.00 hour of administrative assistant time, 0.50 hours of time each from managers and attorneys, and 0.33 hours of time from information technology staff in each succeeding year, and the fourth quartile will require 0.50 hours of administrative assistant time, 0.25 hours of time each from managers and attorneys, and 0.17 hours from information technology staff.
Estimated first-year costs for recordkeeping requirements in final § 201.304(c) totaled $11,000 for live poultry dealers,
Total expected first year costs for small businesses, including one time reviewing costs and recordkeeping costs will be $192,000 for packers, $37,000 for swine contractors, and $24,000 for live poultry dealers. The table below lists expected costs for small businesses subject to §§ 201.304 and 201.306. AMS expects marginal costs to total $255,000 in the first year. Ten-year costs annualized at three percent will be $107,000 for packers, $13,000 for swine contractors, and $11,000 for live poultry dealers. Total ten-year costs annualized at three percent will be expected to be $131,000.
The table below shows that ten-year costs annualized at seven percent will be $109,000 for packers, $14,000 for swine contractors, and $11,000 for live poultry dealers. Total ten-year costs annualized at seven percent will be expected to be $134,000.
Live poultry dealers annually file reports with AMS that list each firm's net sales. Packers that purchase more than $500,000 annually in livestock also file annual reports that list net sales. While packers that annually slaughter less than $500,000 in livestock also file annual reports with AMS, in order to reduce the reporting requirements for small packers, they are not required to provide annual net sales.
Data from the annual reports enables AMS to compare average net sales for small pork packers, beef packers, and live poultry dealers to the expected costs of §§ 201.304 and 201.306 in the table below. A shortcoming in the comparison is that net sales for smallest packers, those that purchase less than $500,000 in livestock, are not included in the average.
Swine contractors are not required to file annual reports with AMS, and similar net sales data are not available for swine contractors. Census of Agriculture's data have the number of head sold by size classes for farms that sold their own hogs and pigs in 2017 and that identified themselves as contractors or integrators, but not the value of sales nor the number of head sold from the farms of the contracted production. To estimate average revenue per establishment, AMS used the estimated average value per head for sales of all swine operations and the production values for firms in the Agriculture Census size classes for swine contractors.
Table 19 compares the average per entity first-year costs of final §§ 201.304 and 201.306 to the average revenue per establishment for all regulated small businesses. First-year costs are appropriate for a threshold analysis because all the costs will occur in the first year. First-year costs per regulated entity are considerably higher than annualized costs, and any ratio of annualized costs to revenues will be less than a ratio of first-year costs to revenues.
Average first-year costs as a percent of revenues are small. It is highest for swine contractors because average revenues for swine contractors are considerably smaller than average revenues for packers and live poultry dealers. At 0.0711 percent, the average first-year cost is small compared to revenue.
Average net sales for packers listed in Table 18 have the problem of excluding the smallest packers, and consequently the averages are biased toward being too large. However, first-year cost as a percent of net sales is 0.0007 percent. Estimated first year cost for each packer is $552. These are relatively small numbers. If average net sales for each packer were only one hundredth of the amount listed in Table 19, estimated average first-year costs will be less than 0.1 percent of net sales.
AMS has limited data on revenues for the smallest packers and live poultry dealers. One hundred eleven packers submitted shortened annual reports to AMS because they purchased less than $500,000 in livestock. For the largest of these small packers, annual revenues are likely close to $500,000 and expected costs will be about 0.07 percent.
AMS also considered a Small Business Exemption Alternative to final §§ 201.304 and 201.306. The Small Business Exemption Alternative will be the same as the final §§ 201.304 and 201.306 in all respects with the exception that none of the recordkeeping requirements in § 201.304(c) will apply to small businesses. This Small Business Exemption Alternative will cost small packers, swine contractors, and live poultry dealers less than §§ 201.304 and 201.306 will cost. Recordkeeping costs comprised the largest share of the costs associated with §§ 201.304 and 201.306.
Although the Small Business Exemption Alternative will not require small businesses to keep any additional records, small businesses will still be required to comply with all the other provisions of §§ 201.304 and 201.306. AMS expects that small live poultry dealers, small packers, and small swine contractors will need to review the new rule and determine whether the rule will require any changes to their procurement contracts or other business practices and make the necessary changes. AMS estimated that costs will consist of one hour of a manager's time and one hour of a lawyer's time to review the requirements of final §§ 201.304 and 201.306. This amounts to expected first-year costs of $234
The table below lists expected costs for small businesses subject to the Small Business Exemption Alternative. AMS expects marginal costs to total $120,000 in the first year. The Small Business Exemption Alternative is expected to cost $81,000, $25,000, and $13,000 in the first year for packers, swine contractors, and live poultry dealers, respectively.
Ten-year costs annualized at three percent will be $9,000 for packers, $3,000 for swine contractors, and $1,000 for live poultry dealers. This amounts to $27 for each live poultry dealer, swine contractor, and packer. Total ten-year costs annualized at three percent will be expected to be $14,000.
Ten-year costs annualized at seven percent will be $11,000 for packers, $3,000 for swine contractors, and $2,000 for live poultry dealers. This amounts to $31 for each live poultry dealer, swine contractor, and packer. Total ten-year costs annualized at seven percent will be expected to be $16,000.
The table below compares the average per entity first-year costs of the Small Business Exemption Alternative to the average revenue for each regulated small business. First-year costs are appropriate for a threshold analysis because all the costs associated with the alternative will occur in the first year.
Average first-year costs as a percent of revenues are small. Similar to §§ 201.304 and 201.306, relative costs are highest for swine contractors because average revenues for swine contractors are considerably smaller than average revenues for packers and live poultry dealers. At 0.0482 percent, the first-year cost to swine contractors is small compared to revenue.
Average net sales for packers listed in Table 20 have the same problem as the net sales figures in Table 18. They exclude the smallest packers, and consequently the averages are biased toward being too large. However, first-year cost as a percent of net sales for packers purchasing more than $500,000 per year is 0.0002 percent. Estimated first year cost for each packer is $234. Costs will be less than 0.1 percent of revenues for any packer with revenue greater than $23,400. Even for the smallest packer that AMS regulates, $234 will not likely have a significant economic impact.
Expected costs for small businesses under final §§ 201.304 and 201.306 will be more than double the expected costs for small businesses under a Small Business Exemption Alternative. The cost difference is due to recordkeeping requirements. First-year costs will be $159,000 more for final §§ 201.304 and 201.306 than the Small Business Exemption Alternative.
With either the Small Business Exemption Alternative or the final rule, AMS expects the costs per entity to be relatively small. The number of regulated entities that could experience a cost increase is substantial. Most regulated packers and live poultry dealers are small businesses. However, AMS expects that few small businesses will experience significant costs. For all three groups of regulated entities: packers, live poultry dealers, and swine contractors, average first year costs are expected to amount to less than 0.1 percent of annual revenue for either of the alternatives. AMS expects that any additional costs to small packers, live poultry dealers, and swine contractors from this rulemaking will not change their ability to continue operations or place any small businesses at a competitive disadvantage.
AMS chose final §§ 201.304 and 201.306 over the Small Business Exemption Alternative because AMS wishes to prevent the kind of undue prejudices and unjust discrimination described in the rule. AMS believes that keeping relevant records serves as constant reminder to all packers, live poultry dealers, and swine contractors that they cannot practice undue prejudice on the basis of protected bases and protected actions; retaliate on the basis of protected activities or actions; or deceive on the basis of contract formation, performance, termination, or refusal.
Final §§ 201.304 and 201.306 are not expected to have a significant economic impact on a substantial number of small business entities as defined in the Regulatory Flexibility Act (5 U.S.C. 601
E.O. 13175 requires Federal agencies to consult with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes or the distribution of power and responsibilities between the Federal Government and Indian Tribes.
Three commenters including the Cherokee Nation, the Coalition of Large Tribes (COLT), and an academic commenter who is the executive
The Civil Rights Impact Analysis found that Asian, and Native Hawaiians or Other Pacific Islanders are disproportionately impacted by this rule. Other impacted producers, including Men, Women, Hispanics, Whites, Black/African Americans, and American Indians, are not disproportionately impacted by this rule.
AMS has considered the potential civil rights implications of this final rule on members of protected groups to ensure that no person or group will be adversely or disproportionately at risk or discriminated against on the basis of race, color, national origin, gender, religion, age, disability, sexual orientation, marital or family status, or protected genetic information.
AMS has determined that this final rule does not have substantial direct effects on one or more Tribes that would require consultation. If a Tribe requests consultation, AMS will work with USDA's Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress. AMS will also conduct outreach to ensure that Tribes and Tribal members are aware of the requirements and benefits under this final rule.
To ensure the potential disparately impacted groups identified above receive the full measure of the positive impacts of this new regulation, AMS will provide addition outreach actions directed toward these groups.
This rule has been reviewed under Executive Order 12988. This rule is not intended to have retroactive effect. This rule would not preempt State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rulemaking. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule. Nothing in this rule is intended to interfere with a person's right to enforce liability against any person subject to the Act under authority granted in section 308 of the Act.
USDA is committed to complying with the E-Government Act by promoting the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L.
AMS expects that the direct costs of this final rule will be 0.0002 percent of industry revenues in the first year of the rule, or $586,000. Indirect costs would have to be nearly 300 times
In addition, AMS takes note of the exemption from UMRA for rules enforcing Constitutional rights of individuals or establishing or enforcing a statutory right that prohibits discrimination on the basis of age, race, color, religion, sex, national origin, handicap, or disability. (2 U.S.C. 1503) Provisions of this rule enforce the Act's prohibition against unjust discrimination and undue prejudice to prohibit adverse treatment on the basis of race, color, religion, national origin (including ethnicity), sex (including sexual orientation and gender identity, as well as pregnancy), disability, marital status, or age. The rule also prohibits retaliatory and adverse actions that interfere with lawful communications, assertion of rights, associational participation, and other protected activities.
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act, 5 U.S.C. 801
Confidential business information, Reporting and recordkeeping requirements, Stockyards, Surety bonds, Trade practices.
For the reasons set forth in the preamble, AMS amends 9 CFR part 201 as follows:
7 U.S.C. 181-229c.
For purposes of this subpart, the following definitions apply:
(a)
(i) On the basis of the covered producer's race, color, religion, national origin, sex (including sexual orientation and gender identity), disability, marital status, or age.
(ii) On the basis of the covered producer's status as a cooperative.
(2) Actions that prejudice, disadvantage, inhibit market access, or are otherwise adverse under paragraph (a)(1) of this section are as follows:
(i) Offering contract terms that are less favorable than those generally or ordinarily offered to similarly situated covered producers.
(ii) Refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers.
(iii) Performing under or enforcing a contract differently than with similarly situated covered producers.
(iv) Requiring a contract modification or renewal on terms less favorable than similarly situated covered producers.
(v) Terminating or not renewing a contract.
(vi) Any other action that a reasonable covered producer would find materially adverse.
(3) The following actions by a regulated entity do not prejudice,
(i) Fulfilling a religious commitment relating to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry.
(ii) A Federally recognized Tribe, including its wholly or majority-owned entities, corporations, or Tribal organizations, performing its Tribal governmental functions.
(b)
(2) The following activities by covered producers are protected under paragraph (b)(1) of this section unless otherwise prohibited by Federal, Tribal, or State law, including antitrust laws:
(i) Communicating with a government entity or official or petitioning a government entity or official for redress of grievances with respect to livestock, meats, meat food products, livestock products in unmanufactured form, or live poultry.
(ii) Refusing a request of the regulated entity to engage in a communication with a government entity or official that is not required by law.
(iii) Asserting the right to form or join, or to refuse to form or join, a producer or grower association or organization, or cooperative or to collectively process, prepare for market, handle, or market livestock or poultry.
(iv) Communicating or cooperating with a person for the purposes of improving production or marketing of livestock or poultry.
(v) Communicating, negotiating, or contracting with a regulated entity, another covered producer, or with a commercial entity or consultant, for the purpose of exploring or entering into a business relationship.
(vi) Supporting or participating as a witness in any proceeding under the Act, or any proceeding that relates to an alleged violation of any law by a regulated entity.
(vii) Asserting any of the rights granted under Act or this part, or asserting contract rights.
(3) The following actions are considered retaliation or an otherwise adverse action under paragraph (b)(1) of this section:
(i) Terminating or not renewing a contract.
(ii) Performing under or enforcing a contract differently than with similarly situated covered producers.
(iii) Requiring a contract modification or a renewal on terms less favorable than similarly situated covered producers.
(iv) Refusing to deal with a covered producer on terms generally or ordinarily offered to similarly situated covered producers.
(v) Interfering in a farm real estate transaction or a contract with third parties.
(vi) Any other action that a reasonable covered producer would find materially adverse.
(c)
(2) Relevant records to paragraph (c)(1) of this section may include: policies and procedures, staff training materials, materials informing covered producers regarding reporting mechanisms and protections, compliance testing, board of directors' oversight materials, and the number and nature of complaints received relevant to this section.
(a)
(b)
(c)
(d)
(e)
If any provision of this subpart, or any component of any provision, is declared invalid or the applicability thereof to any person or circumstances is held invalid, it is the Agricultural Marketing Service's intention that the validity of the remainder of this subpart or the applicability thereof to other persons or circumstances shall not be affected thereby with the remaining provision, or component of any provision, to continue in effect.
Environmental Protection Agency (EPA).
Final rule.
Based on the Environmental Protection Agency's (EPA's) reconsideration of the air quality criteria and the national ambient air quality standards (NAAQS) for particulate matter (PM), the EPA is revising the primary annual PM
This final rule is effective May 6, 2024.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2015-0072. All documents in the docket are listed on the
Dr. Lars Perlmutt, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail Code C539-04, Research Triangle Park, NC 27711; telephone: (919) 541-3037; fax: (919) 541-5315; email:
The following topics are discussed in this preamble:
This document presents the Administrator's final decisions for the reconsideration of the 2020 final decision on the primary (health-based) and secondary (welfare-based) National Ambient Air Quality Standards (NAAQS) for Particulate Matter (PM). More specifically, this document summarizes the background and rationale for the Administrator's final decisions to revise the primary annual PM
The most recent of the PM NAAQS was completed in December 2020. In that review, the EPA retained the primary and secondary NAAQS, without revision (85 FR 82684, December 18, 2020). Following publication of the 2020 final action, several parties filed petitions for review and petitions for reconsideration of the EPA's final decision.
In June 2021, the Agency announced its decision to reconsider the 2020 PM NAAQS final action.
The final decisions presented in this document on the primary PM
The available evidence in the 2019 ISA continues to provide support for factors that may contribute to increased risk of PM
The quantitative risk assessment, as well as policy considerations in the 2022 PA, also inform the final decisions on the primary PM
In its advice to the Administrator, in its review of the 2021 draft PA, the CASAC concurred that the currently available health effects evidence calls into question the adequacy of the primary annual PM
In considering how to revise the suite of primary PM
As in 2012, the Administrator concludes that the most effective way to reduce total population risk associated with both long- and short-term PM
With regard to the primary 24-hour PM
The primary PM
With respect to the secondary PM standards, this reconsideration focuses on visibility, climate, and materials effects.
The final revisions to the primary annual PM
On other topics, the EPA is finalizing two sets of changes to the PM
With regard to monitoring-related activities, the EPA finalizes revisions to data calculations and ambient air monitoring requirements for PM to improve the usefulness and appropriateness of data used in regulatory decision making and to better characterize air quality in communities that are at increased risk of PM
In setting the NAAQS, the EPA may not consider the costs of implementing the standards. This was confirmed by the Supreme Court in
Two sections of the Clean Air Act (CAA) govern the establishment and revision of the NAAQS. Section 108 (42 U.S.C. 7408) directs the Administrator to identify and list certain air pollutants and then to issue air quality criteria for those pollutants. The Administrator is to list those pollutants “emissions of which, in his judgment, cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare”; “the presence of which in the ambient air results from numerous or diverse mobile or stationary sources”; and for which he “plans to issue air quality criteria. . . .” (42 U.S.C. 7408(a)(1)). Air quality criteria are intended to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air. . . .” (42 U.S.C. 7408(a)(2)).
Section 109 [42 U.S.C. 7409] directs the Administrator to propose and promulgate “primary” and “secondary” NAAQS for pollutants for which air quality criteria are issued [42 U.S.C. 7409(a)]. Section 109(b)(1) defines primary standards as ones “the attainment and maintenance of which in the judgment of the Administrator, based on such criteria and allowing an adequate margin of safety, are requisite to protect the public health.”
In setting primary and secondary standards that are “requisite” to protect public health and welfare, respectively, as provided in section 109(b), the EPA's task is to establish standards that are neither more nor less stringent than necessary. In so doing, the EPA may not consider the costs of implementing the standards. See generally
The requirement that primary standards provide an adequate margin of safety was intended to address uncertainties associated with inconclusive scientific and technical information available at the time of standard setting. It was also intended to provide a reasonable degree of protection against hazards that research has not yet identified. See
In addressing the requirement for an adequate margin of safety, the EPA considers such factors as the nature and severity of the health effects involved, the size of the sensitive population(s), and the kind and degree of uncertainties. The selection of any particular approach to providing an adequate margin of safety is a policy choice left specifically to the Administrator's judgment. See
Section 109(d)(1) of the Act requires the review every five years of existing air quality criteria and, if appropriate, the revision of those criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health and welfare. Under the same provision, the EPA is also to review every five years and, if appropriate, revise the NAAQS, based on the revised air quality criteria. Section 109(d)(1) also provides that the Administrator may review and revise criteria or promulgate new standards earlier or more frequently.
Section 109(d)(2) addresses the appointment and advisory functions of an independent scientific review committee. Section 109(d)(2)(A) requires the Administrator to appoint this committee, which is to be composed of “seven members including at least one member of the National Academy of Sciences, one physician, and one person representing State air
As previously noted, the Supreme Court has held that section 109(b) “unambiguously bars cost considerations from the NAAQS-setting process.”
States are primarily responsible for ensuring attainment and maintenance of ambient air quality standards once the EPA has established them. Under section 110, Part C, and Part D, Subparts 1 and 4 of the CAA, and related provisions and regulations, States are to submit, for the EPA's approval, State implementation plans (SIPs) that provide for the attainment and maintenance of the NAAQS for PM through control programs directed to sources of the pollutants involved. The States, in conjunction with the EPA, also administer the prevention of significant deterioration of air quality program that covers these pollutants (see 42 U.S.C. 7470-7479). In addition, Federal programs provide for or result in nationwide reductions in emissions of PM and its precursors under Title II of the Act, 42 U.S.C. 7521-7574, which involves controls for motor vehicles and nonroad engines and equipment; the new source performance standards under section 111 of the Act, 42 U.S.C. 7411; and the national emissions standards for hazardous pollutants under section 112 of the Act, 42 U.S.C. 7412.
The EPA first established NAAQS for PM in 1971 (36 FR 8186, April 30, 1971), based on the original Air Quality Criteria Document (AQCD) (DHEW, 1969).
In October 1979 (44 FR 56730, October 2, 1979), the EPA announced the first periodic review of the air quality criteria and NAAQS for PM. Revised primary and secondary standards were promulgated in 1987 (52 FR 24634, July 1, 1987). In the 1987 decision, the EPA changed the indicator for particles from TSP to PM
In April 1994, the EPA announced its plans for the second periodic review of the air quality criteria and NAAQS for PM, and in 1997 the EPA promulgated revisions to the NAAQS (62 FR 38652, July 18, 1997). In the 1997 decision, the EPA determined that the fine and coarse fractions of PM
Following promulgation of the 1997 PM NAAQS, petitions for review were filed by several parties, addressing a broad range of issues. In May 1999, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) upheld the EPA's decision to establish fine particle standards and to regulate coarse particle pollution, but vacated the 1997 PM
The D.C. Circuit also addressed more general issues related to the NAAQS, including issues related to the consideration of costs in setting NAAQS and the EPA's approach to establishing the levels of NAAQS. Regarding the cost issue, the court reaffirmed prior rulings holding that in setting NAAQS the EPA is “not permitted to consider the cost of implementing those standards.”
The D.C. Circuit's holding on the cost and constitutional issues were appealed to the United States Supreme Court. In February 2001, the Supreme Court issued a unanimous decision upholding the EPA's position on both the cost and constitutional issues.
The Supreme Court remanded the case to the D.C. Circuit for resolution of any remaining issues that had not been addressed in that court's earlier rulings. Id. at 475-76. In a March 2002 decision, the D.C. Circuit rejected all remaining challenges to the standards, holding that the EPA's PM
In October 1997, the EPA published its plans for the third periodic review of the air quality criteria and NAAQS for PM (62 FR 55201, October 23, 1997). After the CASAC and public review of several drafts, the EPA's National Center for Environmental Assessment (NCEA) finalized the AQCD in October 2004 (U.S. EPA, 2004a). The EPA's Office of Air Quality Planning and Standards (OAQPS) finalized a Risk Assessment and Staff Paper in December 2005 (Abt Associates, 2005; U.S. EPA, 2005).
Several parties filed petitions for review following promulgation of the revised PM NAAQS in 2006. On February 24, 2009, the D.C. Circuit issued its opinion in the case
In June 2007, the EPA initiated the fourth periodic review of the air quality criteria and the PM NAAQS by issuing a call for information (72 FR 35462, June 28, 2007). Based on the NAAQS review process, as revised in 2008 and again in 2009,
In December 2012, the EPA announced its final decisions to revise the primary NAAQS for PM to provide increased protection of public health (78 FR 3086, January 15, 2013). With regard to primary standards for PM
As with previous reviews, petitioners challenged the EPA's final rule. Petitioners argued that the EPA acted unreasonably in revising the level and form of the annual standard and in amending the monitoring network provisions. On judicial review, the revised standards and monitoring requirements were upheld in all respects.
In December 2014, the EPA announced the initiation of the current periodic review of the air quality criteria for PM and of the PM
The input received at the workshop guided the EPA staff in developing a draft IRP, which was reviewed by the CASAC Particulate Matter Panel and discussed on public teleconferences held in May 2016 (81 FR 13362, March 14, 2016) and August 2016 (81 FR 39043, June 15, 2016). Advice from the CASAC, supplemented by the Particulate Matter Panel, and input from the public were considered in developing the final IRP (U.S. EPA, 2016). The final IRP discusses the approaches to be taken in developing key scientific, technical, and policy documents in the review and the key policy-relevant issues that frame the EPA's consideration of whether the primary and/or secondary NAAQS for PM should be retained or revised.
In May 2018, the then-Administrator issued a memorandum announcing the Agency's intention to conduct the review of the PM NAAQS in such a manner as to ensure that any necessary revisions were finalized by December 2020 (Pruitt, 2018). Following this memo, on October 10, 2018, the then-Administrator additionally announced that the role of reviewing the key assessments developed as part of the ongoing review of the PM NAAQS (
The EPA released the draft ISA in October 2018 (83 FR 53471, October 23, 2018). The draft ISA was reviewed by the chartered CASAC at a public meeting held in Arlington, VA in December 2018 (83 FR 55529, November 6, 2018) and was discussed on a public teleconference in March 2019 (84 FR 8523, March 8, 2019). The CASAC provided its advice on the draft ISA in a letter to the then-Administrator dated April 11, 2019 (Cox, 2019a). The EPA addressed these comments in the final ISA, which was released in December 2019 (U.S. EPA, 2019a).
The EPA released the draft PA in September 2019 (84 FR 47944, September 11, 2019). The draft PA was reviewed by the chartered CASAC and discussed in October 2019 at a public meeting held in Cary, NC. Public comments were received via a separate public teleconference (84 FR 51555, September 30, 2019). A public meeting to discuss the chartered CASAC letter and response to charge questions on the draft PA was held in Cary, NC, in October 2019 (84 FR 51555, September 30, 2019), and the CASAC provided its advice on the draft PA, including its advice on the current primary and secondary PM standards, in a letter to the then-Administrator dated December 16, 2019 (Cox, 2019b). With regard to the primary standards, the CASAC recommended retaining the current 24-hour PM
On April 14, 2020, the EPA proposed to retain all of the primary and secondary PM standards, without revision. These proposed decisions were published in the
In reaching his final decision to retain the primary annual and 24-hour PM
With respect to the annual PM
With regard to the primary PM
With regard to the secondary PM standards, the then-Administrator concluded that there was insufficient information available to establish any distinct secondary PM standards to address climate and materials effects of PM. For visibility effects, he found that in the absence of a monitoring network for direct measurement of light extinction, a calculated light extinction indicator that utilizes the IMPROVE algorithms continued to provide a reasonable basis for defining a target level of protection against PM-related visibility impairment. He further found that a visibility index with a 24-hour averaging time was reasonable based on its stability and suitability for representing subdaily periods, and a form based on the 3-year average of annual 90th percentile values was reasonable based on its stability and that it represents the median of the 20 percent worst visibility days which are targeted under the Regional Haze program. With regard to the level of a visibility index, the then-Administrator judged it appropriate to establish a target level of protection of 30 dv, reflecting the upper end of the range of visibility impairment judged to be acceptable by at least 50% of study participants in the available public preference studies, taking into consideration the variability, limitations and uncertainties of the public preference studies. The then-Administrator judged that the secondary 24-hour PM
Following publication of the 2020 final action, several parties filed petitions for review and petitions for reconsideration of the EPA's final decision. The petitions for review were filed in the D.C. Circuit and the Court consolidated the cases.
Executive Order 13990 directed review of certain agency actions (86 FR 7037, January 25, 2021).
On June 10, 2021, the Agency announced its decision to reconsider the 2020 PM NAAQS final action because the available scientific evidence and technical information indicate that the current standards may not be adequate to protect public health and welfare, as required by the Clean Air Act.
The EPA staff conclusions detailed in the 2020 PA in combination with the CASAC advice that informed the Administrator's decisions regarding the 2020 final action, studies highlighted by public comments on the 2020 proposal, and the numerous studies published since the literature cutoff date of the 2019 ISA all informed the scope of the reconsideration.
In its review of the 2019 draft PA, some members of the CASAC had recommended that greater attention should be given to accountability studies and epidemiologic studies that employ alternative methods for confounder control (also referred to as causal inference or causal modeling studies) in order to “more fully account for effects of confounding, measurement and estimation errors, model uncertainty, and heterogeneity” in epidemiologic studies (Cox, 2019b, p. 8 of consensus responses). In addition, public commenters submitted a number of recent studies published after the literature cutoff date for the 2019 ISA that would have been considered within the scope of the 2019 ISA. While the EPA provisionally considered these studies in responding to public comments,
In preparing to reconsider the 2020 final decision for the PM NAAQS, the Agency revisited the need to reopen the air quality criteria, given the amount of time that had passed since the literature cutoff date of the 2019 ISA (
The EPA also explained that the draft ISA Supplement and draft PA would be reviewed at a public meeting by the CASAC, and the public would have opportunities to comment on these documents during the CASAC review process, as well as to provide input during the rulemaking through the public comment process and public hearings on the proposed rulemaking.
On March 31, 2021, the Administrator announced his decision to reestablish the membership of the CASAC to “ensure the agency received the best possible scientific insight to support our work to protect human health and the environment.”
The draft ISA Supplement was released in September 2021 (U.S. EPA, 2021a; 86 FR 54186, September 30, 2021), and included a discussion of the rationale and scope of the Supplement. As explained therein, the ISA Supplement focuses on a thorough evaluation of some studies that became available after the literature cutoff date of the 2019 ISA that could either further inform the adequacy of the current PM NAAQS or address key scientific topics that have evolved since the literature cutoff date for the 2019 ISA. In selecting the health effects to evaluate within the ISA Supplement, the EPA focused on health effects for which the evidence supported a “causal relationship” because those were the health effects that were most useful in informing conclusions in the 2020 PA (U.S. EPA, 2022a, section 1.2.1).
Building on the rationale presented in section 1.2.1, the ISA Supplement considers peer-reviewed studies published from approximately January 2018 through March 2021 that meet the following criteria:
○ U.S. and Canadian epidemiologic studies for health effect categories where the 2019 ISA concluded a “
U.S. and Canadian epidemiologic studies that employed alternative methods for confounder control or conducted accountability analyses (
○ U.S. and Canadian studies that provide new information on public preferences for visibility impairment and/or developed methodologies or conducted quantitative analyses of light extinction.
○ Experimental studies (
○ U.S.- and Canadian-based epidemiologic studies that examined the relationship between PM
○ At-Risk Populations.
U.S.- and Canadian-based epidemiologic or exposure studies examining potential disparities in either PM
Given the narrow scope of the ISA Supplement, it is important to recognize that the evaluation does not encompass the full multidisciplinary evaluation presented within the 2019 ISA that would result in weight-of-evidence conclusions on causality (
In developing a revised PA to support the reconsideration, the EPA considered the available scientific evidence, including the evidence presented in the 2019 ISA and ISA Supplement. The 2022 PA considered the quantitative and technical information presented in the 2020 PA, in addition to new and updated analyses conducted since the 2020 final decision. For those health and welfare effects for which the ISA Supplement evaluated recently available studies (
The CASAC PM panel met at a virtual public meeting in November 2021 to review the draft ISA Supplement (86 FR 52673, September 22, 2021). A virtual public meeting was then held in February 2022, and during this meeting the chartered CASAC considered the CASAC PM panel's draft letter to the Administrator on the draft ISA Supplement (87 FR 958, January 7, 2022).
The chartered CASAC provided its advice on the draft ISA Supplement in a letter to the EPA Administrator dated March 18, 2022 (Sheppard, 2022b). In its review of the draft ISA Supplement, the CASAC noted that they found “the Draft ISA Supplement to be a well-written, comprehensive evaluation of the new scientific information published since the 2019 PM ISA” (Sheppard, 2022b, p. 2 of letter). Furthermore, the CASAC stated that “the final Integrated Science Assessment (ISA) Supplement . . . deserve[s] the Administrator's full consideration and [is] adequate for rulemaking” (Sheppard, 2022b, p. 2 of letter). The CASAC generally endorsed EPA's decisions regarding the limited scope of the draft ISA Supplement, stating that “this limitation [on scope] is appropriate for the targeted purpose of the Draft ISA Supplement” although the CASAC noted it would not be appropriate for ISAs generally, and recommended that the EPA provide additional acknowledgment and explanation for the limited scope (Sheppard, 2022b, p. 2 of letter; see also pp. 2-3 of consensus responses). The EPA specifically noted in the final ISA Supplement, which was released in May 2022 (U.S. EPA, 2022a; hereafter referred to as the ISA Supplement throughout this document) that the “targeted approach to developing the Supplement to the 2019 PM ISA for the purpose of reconsidering the 2020 PM NAAQS decision does not reflect a change to EPA's approach for developing ISAs for NAAQS reviews.” Thus, the evidence presented within the 2019 ISA, along with the targeted identification and evaluation of new scientific information in the ISA Supplement, provides the scientific basis for the reconsideration of the 2020 PM NAAQS final decision.
The draft PA was released in October 2021 (86 FR 56263, October 8, 2021). The CASAC PM panel met at a virtual public meeting in December 2021 to review the draft PA (86 FR 52673, September 22, 2021). A virtual public meeting was then held in February 2022 and March 2022, and during this meeting the chartered CASAC considered the CASAC PM panel's draft letter to the Administrator on the draft PA (87 FR 958, January 7, 2022). The chartered CASAC provided its advice on the draft PA in a letter to the EPA Administrator dated March 18, 2022 (Sheppard, 2022a). The EPA took steps to address these comments in revising and finalizing the PA. The 2022 PA considers the scientific evidence presented in the 2019 ISA and ISA Supplement and considers the quantitative and technical information presented in the 2020 PA, along with updated and newly available analyses since the completion of the 2020 review. For those health and welfare effects for which the ISA Supplement evaluated recently available evidence and for which updated quantitative analyses were supported (
Drawing from his consideration of the scientific evidence assessed in the 2019 ISA and ISA Supplement and the analyses in the 2022 PA, including the uncertainties in the evidence and analyses, and from his consideration of advice from the CASAC, on January 5, 2023, the Administrator proposed to revise the level of the primary annual PM
As in prior reviews, the EPA is basing its decision in this reconsideration on studies and related information in the air quality criteria, which have undergone CASAC and public review. These studies assessed in the 2019 ISA
This approach, and the decision to rely on the studies and related information in the air quality criteria, which have undergone CASAC and public review, is consistent with the EPA's practice in prior NAAQS reviews and its interpretation of the requirements of the CAA. Since the 1970 amendments, the EPA has taken the view that NAAQS decisions are to be based on scientific studies and related information that have been assessed as a part of the pertinent air quality criteria, and the EPA has consistently followed this approach. This longstanding interpretation was strengthened by new legislative requirements enacted in 1977, which added section 109(d)(2) of the Act concerning CASAC review of air quality criteria. See 71 FR 6114, 61148 (October 17, 2006, final decision on review of NAAQS for particulate matter) for a detailed discussion of this issue and the EPA's past practice.
As discussed in the EPA's 1993 decision not to review the O
Accordingly, the EPA is basing the final decisions in this reconsideration on the studies and related information included in the PM air quality criteria (including the 2019 PM ISA and ISA Supplement) that have undergone rigorous review by the EPA, the CASAC, and the public. The EPA will consider these “new” studies for inclusion in the air quality criteria for the next PM NAAQS review, which the EPA expects to begin soon after the conclusion of this reconsideration and which will provide the opportunity to fully assess these studies through a more rigorous review process involving the EPA, the CASAC, and the public.
This section provides a summary of basic information related to PM ambient air quality. It summarizes information on the distribution of particle size in ambient air (section I.D.1), sources and emissions contributing to PM in the ambient air (section I.D.2), monitoring ambient PM in the U.S. (section I.D.3), ambient PM concentrations and trends in the U.S. (I.D.4), characterizing ambient PM
In ambient air, PM is a mixture of substances suspended as small liquid and/or solid particles (U.S. EPA, 2019a, section 2.2) and distinct health and welfare effects have been linked with exposures to particles of different sizes. Particles in the atmosphere range in size from less than 0.01 to more than 10 μm
PM is composed of both primary (directly emitted particles) and secondary particles. Primary PM is derived from direct particle emissions from specific PM sources while secondary PM originates from gas-phase precursor chemical compounds present in the atmosphere that have participated in new particle formation or condensed onto existing particles (U.S. EPA, 2019a, section 2.3). As discussed further in the 2019 ISA (U.S. EPA, 2019a, section 2.3.2.1), secondary PM is formed in the atmosphere by photochemical oxidation reactions of both inorganic and organic gas-phase precursors. Precursor gases include sulfur dioxide (SO
In recent years, the frequency and magnitude of wildfires have increased (U.S. EPA, 2019a). The magnitude of the public health impact of wildfires is substantial both because of the increase in PM
Wildfire events produce high PM emissions that may impact the PM concentrations in ambient air to the extent that the concentrations result in an exceedance or violation which may affect the design value in a given area. The EPA's Exceptional Events Rule (81 FR 68216, October 3, 2016) describes the process by which air agencies may request to exclude `event-influenced' data caused by exceptional events, which can include wildfires and prescribed fires on wildland. The EPA has issued guidance specifically addressing exceptional events demonstrations for both wildfires and prescribed fires on wildland. These documents are available on EPA's Exceptional Events Program website.
To promote uniform application of the air quality standards set forth under the CAA and to achieve the degree of public health and welfare protection intended for the NAAQS, the EPA establishes PM Federal Reference Methods (FRMs) for both PM
The PM
Under 40 CFR part 50, appendix L, and 40 CFR part 53, and 40 CFR part 58 appendix D there are three main methods components of the PM
This section summarizes available information on recent ambient PM concentrations in the U.S. and on trends in PM air quality. Sections I.D.4.a and I.D.4.b summarize information on PM
At monitoring sites in the U.S., annual PM
Recent ambient PM
The recent deployment of PM
Ambient PM
Based on recent air quality data, the major chemical components of PM
An examination of PM
At long-term monitoring sites in the U.S., the 2017-2019 average of 2nd highest 24-hour PM
Recent ambient PM
Compared to previous reviews, data available from the NCore monitoring network in the current reconsideration allows a more comprehensive analysis of the relative contributions of PM
Since the 2012 review, the availability of PM
Due to the short atmospheric lifetime of PM
Compared to PM
Long-term trends in UFP are not routinely available at U.S. monitoring
Epidemiologic studies use various methods to characterize exposure to ambient PM
Ambient concentrations of PM
For an area to meet the NAAQS, all valid design values
Two types of hybrid approaches that have been utilized in several key PM
In estimating exposure, some studies focus on estimating concentrations in urban areas, while others examine the entire U.S. or large portions of the country. In general, the areas that are not included in the CBSA-only analysis tend to be more rural or less densely populated areas, tend to have lower PM
The 2022 PA next evaluates how the averages of the hybrid model surfaces compare to regulatory design values using both the DI2019 and HA2020 surfaces and how population weighting influences the mean PM
In this reconsideration, background PM is defined as all particles that are formed by sources or processes that cannot be influenced by actions within the jurisdiction of concern. U.S. background PM is defined as any PM formed from emissions other than U.S. anthropogenic (
This section presents the rationale for the Administrator's decision to revise the primary annual PM
In presenting the rationale for the Administrator's decisions and its foundations, section II.A provides background on the general approach for this reconsideration and the basis for the existing standard, and also presents brief summaries of key aspects of the currently available health effects and risk information. Section II.B summarizes the CASAC advice and the basis for the proposed conclusions, addresses public comments received on the proposal and presents the Administrator's conclusions on the adequacy of the current standards, drawing on consideration of the scientific evidence and quantitative risk information, advice from the CASAC, and comments from the public. Section II.C summarizes the Administrator's decision on the primary PM
The general approach for this reconsideration of the 2020 final decision on the primary PM
The final decision on the adequacy of the current primary PM
The current primary PM
The health effects evidence base available in the 2020 review included extensive evidence from previous reviews as well as the evidence that had emerged since the prior review had been completed in 2012. This evidence base, spanning several decades, documents the relationship between short- and long-term PM
Epidemiologic studies reported PM
The risk information available in the 2020 review included risk estimates for air quality conditions just meeting the existing primary PM
Consistent with the general approach routinely employed in NAAQS reviews, the initial consideration in the 2020 review of the primary PM
As an initial matter, the then-Administrator considered the range of scientific evidence evaluating these effects, including studies of at-risk populations, to inform his review of the primary PM
With regard to indicator, the then-Administrator recognized that, consistent with the evidence available in prior reviews, the scientific evidence continued to provide strong support for health effects following short- and long-term PM
With respect to averaging time and form, the then-Administrator noted that the scientific evidence continued to provide strong support for health effects associations with both long-term (
With regard to the form of the 24-hour standard (98th percentile, averaged over three years), the then-Administrator noted that epidemiologic studies continued to provide strong support for health effect associations with short-term (
With regard to the level of the standards, in reaching his final decision, the then-Administrator considered the large body of evidence presented and assessed in the 2019 ISA (U.S. EPA, 2019a), the policy-relevant and risk-based conclusions and rationales as presented in the 2020 PA (U.S. EPA, 2020b), advice from the CASAC, and public comments. In particular, in considering the 2019 ISA and 2020 PA, he considered key epidemiologic studies that evaluated associations between PM
As an initial matter, the then-Administrator considered the protection afforded by both the annual and 24-hour standards together against long- and short-term PM
Thus, in considering the adequacy of the 24-hour standard, the then-Administrator noted the importance of considering whether additional protection was needed against short-term exposures to peak PM
With respect to the epidemiologic evidence, the then-Administrator noted that the studies did not indicate that associations in those studies were strongly influenced by exposures to peak concentrations in the air quality distribution and thus did not indicate the need for additional protection against short-term exposures to peak PM
With regard to the level of the annual standard, the then-Administrator recognized that the annual standard, with its form based on the arithmetic mean concentration, was most appropriately meant to limit the “typical” daily and annual exposures that were most strongly associated with the health effects observed in epidemiologic studies. However, the then-Administrator also noted that while epidemiologic studies examined associations between distributions of PM
The then-Administrator emphasized uncertainties and limitations that were present in epidemiologic studies in previous reviews and persisted in the 2020 review. These uncertainties
Taking into consideration the views expressed by the CASAC members who supported retaining the annual standard, the then-Administrator recognized that epidemiologic studies examined associations between distributions of PM
In addition to the evidence, the then-Administrator also considered the potential implications of the risk assessment. He noted that all risk assessments have limitations and that he remained concerned about the uncertainties in the underlying epidemiologic data used in the risk assessment. The then-Administrator also noted that in previous reviews, these uncertainties and limitations have often resulted in less weight being placed on quantitative estimates of risk than on the underlying scientific evidence itself (
The then-Administrator additionally considered an emerging body of evidence from accountability studies that examined past reductions in ambient PM
When the above considerations were taken together, the then-Administrator concluded that the scientific evidence assessed in the 2019 ISA, together with the analyses in the 2020 PA based on that evidence and consideration of CASAC advice and public comments, did not call into question the adequacy of the public health protection provided by the existing annual and 24-hour PM
In reaching this conclusion in the 2020 review, the then-Administrator judged that the existing standards provided an adequate margin of safety. With respect to the annual standard, the level of 12 µg/m
In addition, based on the then-Administrator's review of the science in the 2020 review, including controlled human exposure studies examining effects following short-term PM
In reaching his final decision in the 2020 review, the then-Administrator concluded that the scientific evidence and technical information continued to support the existing annual and 24-hour PM
The information summarized here and further detailed in section II.B of the proposal (88 FR 5580, January 27, 2023), is an overview of the policy-relevant aspects of the health effects evidence available in this reconsideration; the assessment of this evidence is documented in the 2019 ISA (U.S. EPA, 2019a) and ISA Supplement (U.S. EPA, 2022a) and its policy implications are further discussed in the 2022 PA (U.S. EPA, 2022b). While the 2019 ISA provides the broad scientific foundation for this reconsideration, additional literature has become available since the cutoff date of the 2019 ISA that expands the body of evidence related to mortality and cardiovascular effects for both short- and long-term PM
The ISA Supplement also assessed accountability studies because these types of epidemiologic studies were part of the body of evidence that was a focus of the 2020 review. Accountability studies inform our understanding of the potential for public health improvements as ambient PM
The ISA Supplement also considered recent health effects evidence that addresses key scientific issues where the literature has expanded since the completion of the 2019 ISA.
The evidence presented within the 2019 ISA, along with the targeted identification and evaluation of new scientific information in the ISA Supplement, provides the scientific basis for the reconsideration of the 2020 final decision on the primary PM
The evidence base available in the reconsideration includes decades of research on PM
In the 2012 review, the 2009 ISA reported that the evidence was “sufficient to conclude that the relationship between long-term PM
Cohort studies, which have become available since the completion of the 2009 ISA and evaluated in the 2019 ISA, continue to provide consistent evidence of positive associations between long-term PM
In addition to those cohort studies evaluated in the 2019 ISA, recent North American cohort studies evaluated in the ISA Supplement continue to examine the relationship between long-term PM
Furthermore, studies evaluated in the 2019 ISA and the ISA Supplement that examined cause-specific mortality expand upon previous research that found consistent, positive associations between PM
A series of epidemiologic studies evaluated in the 2019 ISA tested the hypothesis that past reductions in ambient PM
Since the literature cutoff date for the 2019 ISA, a few epidemiologic studies were published that examined the relationship between long-term PM
Additionally, a number of accountability studies, which are epidemiologic studies that evaluate whether an environmental policy or air quality intervention resulted in reductions in ambient air pollution concentrations and subsequent reductions in mortality or morbidity, have emerged and were evaluated in the ISA Supplement (U.S. EPA, 2022a, section 3.2.2.3). For example, Sanders et al. (2020a) examined whether policy actions (
The 2019 ISA also evaluated a small number of studies that used alternative methods for confounder control to further assess relationship between long-term PM
The 2019 ISA and ISA Supplement also evaluated the degree to which recent studies examining the relationship between long-term PM
The 2019 ISA additionally concludes that positive associations between long-term PM
Additionally, a few studies use statistical techniques to reduce uncertainties related to potential confounding to further inform conclusions on causality for long-term PM
An additional important consideration in characterizing the public health impacts associated with PM
The biological plausibility of PM
Taken together, epidemiologic studies, including those evaluated in the 2019 ISA and more recent studies evaluated in the ISA Supplement, consistently report positive associations between long-term PM
The 2009 ISA concluded that “a causal relationship exists between short-term exposure to PM
Multicity studies evaluated in the 2019 ISA and the ISA Supplement provide evidence of primarily positive associations between daily PM
Some studies have expanded the examination of potential confounders including long-term temporal trends, weather, and co-occurring pollutants. Mortality associations were found to remain positive, although in some cases were attenuated, when using different approaches to account for temporal trends or weather covariates (
With regard to copollutants, studies evaluated in the 2019 ISA provide additional evidence that associations between short-term PM
The generally positive associations reported with mortality are supported by a small group of studies employing alternative methods for confounder control or quasi-experimental statistical approaches (U.S. EPA, 2019a, section 11.1.2.1). For example, two studies by Schwartz et al. report associations between PM
The positive associations for total mortality reported across the majority of studies evaluated are further supported by cause-specific mortality analyses, which generally report consistent, positive associations with both cardiovascular and respiratory mortality (U.S. EPA, 2019a, section 11.1.3). Recent multicity studies evaluated in the ISA Supplement add to the body of evidence indicating a relationship between short-term PM
In the 2009 ISA, one of the main uncertainties identified was the regional and city-to-city heterogeneity in PM
A number of studies evaluated in the 2019 ISA and ISA Supplement conducted systematic evaluations of the lag structure of associations for the PM
Multicity studies indicate that positive and statistically significant associations with mortality persist in analyses restricted to short-term (24-hour average PM
Moreover, recent studies evaluated in the ISA Supplement provide additional support for a linear, no-threshold C-R relationship between short-term PM
Overall, epidemiologic studies evaluated in the 2019 ISA and the ISA Supplement build upon and extend the conclusions of the 2009 ISA for the relationship between short-term PM
The scientific evidence reviewed in the 2009 ISA was “sufficient to infer a causal relationship between long-term PM
Consistent with the evidence assessed in the 2009 ISA, the 2019 ISA concludes that recent studies, together with the evidence available in previous reviews, support a causal relationship between long-term exposure to PM
The body of literature examining the relationship between long-term PM
Recent studies published since the literature cutoff date of the 2019 ISA and evaluated in the ISA Supplement further assessed the relationship between long-term PM
Positive associations reported in epidemiologic studies are supported by toxicological evidence evaluated in the 2019 ISA. The positive associations reported in epidemiologic studies are supported by toxicological evidence for increased plaque progression in mice following long-term exposure to PM
Additionally, a number of studies evaluated in the ISA Supplement focusing on morbidity outcomes, including those that focused on incidence of MI, atrial fibrillation (AF), stroke, and congestive heart failure (CHF), expand the evidence pertaining to the shape of the C-R relationship between long-term PM
Longitudinal epidemiologic analyses also report positive associations with markers of systemic inflammation (U.S. EPA, 2019a, section 6.2.11), coagulation (U.S. EPA, 2019a, section 6.2.12), and
In summary, the 2019 ISA concludes that there is consistent evidence from multiple epidemiologic studies illustrating that long-term exposure to PM
The 2009 ISA concluded that “a causal relationship exists between short-term exposure to PM
Studies evaluated in the 2019 ISA provide additional support for a causal relationship between short-term PM
Consistent with the evidence assessed in the 2019 ISA, some studies evaluated in the ISA Supplement report no evidence of an association with stroke, regardless of stroke subtype. Additionally, as in the 2019 ISA, evidence evaluated in the ISA Supplement continues to indicate an immediate effect of PM
The ISA Supplement includes additional epidemiologic studies, published since the literature cutoff date for the 2019 ISA, including accountability analyses and epidemiologic studies that employ alternative methods for confounder control to evaluate the association between short-term PM
A number of controlled human exposure, animal toxicological, and epidemiologic panel studies provide evidence that PM
Animal toxicological studies published since the 2009 ISA and evaluated in the 2019 ISA also support a relationship between short-term PM
In summary, evidence evaluated in the 2019 ISA extends the consistency and coherence of the evidence base evaluated in the 2009 ISA and prior assessments. Epidemiologic studies reporting robust associations in copollutant models are supported by direct evidence from controlled human exposure and animal toxicologic studies reporting independent effects of PM
The 2009 ISA concluded that “a causal relationship is likely to exist between long-term PM
Cohort studies evaluated in the 2019 ISA provided additional support for the relationship between long-term PM
When taken together, the 2019 ISA concludes that the epidemiologic evidence strongly supports a relationship with decrements in lung function growth asthma development in children, as well as increased bronchitis symptoms in children with asthma. Additionally, the epidemiologic
The 2009 ISA (U.S. EPA, 2009a) concluded that a “causal relationship is likely to exist” between short-term PM
Epidemiologic studies evaluated in the 2019 ISA continue to provide strong evidence for a relationship between short-term PM
Epidemiologic studies evaluated in the 2019 ISA expand the assessment of potential copollutant confounding evaluated in the 2009 ISA. There is some evidence that PM
Insight into whether there is an independent effect of PM
The 2019 ISA concludes that “[t]he strongest evidence of an effect of short-term PM
The 2009 ISA concluded that the overall body of evidence was “suggestive of a causal relationship between relevant PM
Since the completion of the 2009 ISA, additional cohort studies provide evidence that long-term PM
To date, relatively few studies have evaluated the potential for copollutant confounding of the relationship between long-term PM
Compared to total (non-accidental) mortality (U.S. EPA, 2019a, section 10.2.4.1.4), fewer studies have examined the shape of the C-R curve for cause-specific mortality outcomes, including lung cancer. Several studies of lung cancer mortality and incidence have reported no evidence of deviations from linearity in the shape of the C-R relationship (Lepeule et al., 2012; Raaschou-Nielsen et al., 2013; Puett et al., 2014), though authors provided only limited discussions of results (U.S. EPA, 2019a, section 10.2.5.1.4).
In support of the biological plausibility of an independent effect of PM
Epidemiologic evidence for associations between PM
Reflecting the very limited evidence available in the 2012 review, the 2009 ISA did not make a causality determination for long-term PM
While the findings described above are most relevant to older adults, several studies of neurodevelopmental effects in children have also been conducted. Epidemiologic studies provided limited evidence of an association between PM
Taken together, the 2019 ISA concludes that studies indicate long-term PM
For other health effect categories that were evaluated for their relationship with PM
Recent studies evaluated in the 2019 ISA also further explored the relationship between short-and long-term UFP exposure and health effects. (
With the advent of the global COVID-19 pandemic, a number of recent studies evaluated in the ISA Supplement examined the relationship between ambient air pollution, specifically PM
The public health implications of the evidence regarding PM
The information available in this reconsideration has not altered our understanding of human populations at risk of health effects from PM
Children make up a substantial fraction of the U.S. population, and often have unique factors that contribute to their increased risk of experiencing a health effect due to exposures to ambient air pollutants because of their continuous growth and development.
In the U.S., older adults, often defined as adults 65 years of age and older, represent an increasing portion of the population and often have pre-existing diseases or conditions that may compromise biological function. While there is limited evidence to indicate that older adults have higher exposures than younger adults, older adults may receive higher doses of PM
Individuals with pre-existing disease may be considered at greater risk of an air pollution-related health effect than those without disease because they are likely in a compromised biological state that can vary depending on the disease and severity. With regard to cardiovascular disease, we first note that cardiovascular disease is the leading cause of death in the U.S., accounting for one in four deaths, and approximately 12% of the adult population in the U.S. has a cardiovascular disease (U.S. EPA, 2019a, section 12.3.1). Strong evidence demonstrates that there is a causal relationship between cardiovascular effects and long- and short-term exposures to PM
With regard to respiratory disease, we first note that the most chronic respiratory diseases in the U.S. are asthma and COPD. Asthma affects a substantial fraction of the U.S. population and is the leading chronic disease among children. COPD primarily affects older adults and contributes to compromised respiratory function and underlying pulmonary inflammation. The body of evidence indicates that individuals with pre-existing respiratory diseases, particularly asthma and COPD, may be at increased risk for PM
There is strong evidence for racial and ethnic disparities in PM
Socioeconomic status (SES) is a composite measure that includes metrics such as income, occupation, or education, and can play a role in access to healthy environments as well as access to healthcare. SES may be a factor that contributes to differential risk from PM
The magnitude and characterization of a public health impact is dependent upon the size and characteristics of the populations affected, as well as the type or severity of the effects. As summarized above, lifestage (children and older adults), race/ethnicity and SES are factors that increase the risk of PM
As noted above, individuals with pre-existing cardiovascular disease and pre-existing respiratory disease may also be at increased risk of PM
With respect to race, American Indians or Alaskan Native populations have the highest prevalence of all heart disease and coronary heart disease, while Black populations have the highest prevalence of hypertension and stroke. Hypertension has the highest prevalence across all racial groups compared to other cardiovascular diseases or conditions, ranging from approximately 22% to 32% of each racial group. Overall, the prevalence of cardiovascular diseases or conditions is lowest for Asians compared to Whites, Blacks, and American Indians or Alaskan Natives. Asthma prevalence is highest among Black and American Indian or Alaska Native populations, while the prevalence of chronic bronchitis and emphysema is generally similar across racial groups. Overall, the prevalence of respiratory diseases is lowest for Asians compared to Whites, Blacks, and American Indians or Alaskan Natives. With regard to ethnicity, cardiovascular and respiratory disease prevalence across all diseases or conditions is generally similar between Hispanic and non-Hispanic populations, although non-Hispanics have a slightly higher prevalence compared to Hispanics.
Taken together, this information indicates that the groups at increased risk of PM
To inform conclusions on the adequacy of the public health protection provided by the current primary PM
Evidence for a particular PM
Controlled human exposure studies have reported that PM
While controlled human exposure studies are important in establishing biological plausibility, it is unclear how the results from these studies alone and the importance of the effects observed in these studies, should be interpreted with respect to adversity to public health. More specifically, impaired vascular function can signal an intermediate effect along the potential biological pathways for cardiovascular effects following short-term exposure to PM
The 2022 PA also notes that it is important to recognize that controlled human exposure studies include a small number of individuals compared to epidemiologic studies. Additionally, these studies tend to include generally healthy adult individuals, who are at a lower risk of experiencing health effects.
Nonetheless, to provide some insight into what these controlled human exposure studies may indicate regarding short-term exposure to peak PM
With respect to animal toxicological studies, the 2019 ISA relies on animal toxicological studies to support the plausibility of a wide range of PM
As with controlled human exposure studies, most animal toxicological studies evaluated in the 2019 ISA have examined effects following exposure to PM
As summarized in section II.A.2.a above, epidemiologic studies examining associations between daily or annual average PM
As an initial matter, in considering the PM
As discussed further in the 2022 PA, studies of daily PM
Thus, in considering PM
In evaluating the overall study-reported means, and concentrations somewhat below the means from epidemiologic studies, the 2022 PA focuses on the form, averaging time and level of the current primary annual PM
In focusing on the annual standard, and in evaluating the range of study-reported exposure concentrations for which the strongest support for adverse health effects exists, the 2022 PA examines exposure concentrations in key epidemiologic studies to determine whether the current primary annual PM
Consistent with the approach taken in 2012, in assessing how the overall mean (or median) PM
Another important consideration is that there are a substantial number of different types of epidemiologic studies available since the 2012 review, included in both the 2019 ISA and the ISA Supplement, that make understanding the relationship between the mean PM
Given the emergence of the hybrid model-based epidemiologic studies since the 2012 review, the 2022 PA explores the relationship between the approaches used in these studies to estimate PM
In the air quality analyses comparing composite monitored PM
The 2022 PA also evaluates data from two hybrid modeling approaches (DI2019 and HA2020) that have been used in several recent epidemiologic studies (U.S. EPA, 2022b, section 2.3.3.2.4).
Based on these results, and similar to conclusions for the monitor-based studies, the 2022 PA generally concludes that study-reported mean concentrations in the studies that employ hybrid modeling approaches and calculate a population-weighted mean are associated with air quality conditions that would be achieved by meeting annual standard levels that are 15-18% higher than study-reported means. Therefore, an annual standard level that is no more than 15-18% higher than the study-reported means would generally maintain air quality exposures to be below those associated with the study-reported mean PM
The 2022 PA notes that while these analyses can be useful to informing the understanding of the relationship between study-reported mean concentrations and the level of the annual standard, some limitations of this analysis must be recognized (U.S. EPA, 2022a, section 3.3.3.2.1). First, the comparisons used only two hybrid modeling approaches. Although these two hybrid modeling surfaces have been used in a number of recent epidemiologic studies, they represent just two of the many hybrid modeling approaches that have been used in epidemiologic studies to estimate PM
Additionally, while some of these epidemiologic studies also provide information on the broader distributions of exposure estimates and/or health events and the PM
As with the experimental studies discussed above, the 2022 PA focuses on epidemiologic studies assessed in the 2019 ISA and ISA Supplement that have the potential to be most informative in reaching decisions on the adequacy of the primary PM
The key epidemiologic studies identified in the 2022 PA indicate generally positive and statistically significant associations between estimated PM
Figure 1 below (U.S. EPA, 2022b, Figure 3-8) highlights the overall mean (or median) PM
Based on its evaluation of study-reported mean concentrations, the 2022 PA notes that key epidemiologic studies conducted in the U.S. or Canada report generally positive and statistically significant associations between estimated PM
The 2022 PA first considers the PM
Other key U.S. epidemiologic studies that use hybrid modeling approaches estimate mean PM
In addition to the mean PM
The 2022 PA next considers the PM
In addition to the expanded body of evidence from the key U.S. epidemiologic studies discussed above, there are also a subset of epidemiologic studies that have emerged that further inform an understanding of the relationship between PM
Restricted analyses are studies that examine health effect associations in analyses with the highest exposures excluded, restricting analyses to daily exposures less than the 24-hour primary PM
Restricted analyses provide additional information on the nature of the association between long- or short-term exposures when analyses are restricted to lower PM
The second type of studies that have recently emerged and further inform the consideration of the relationship between PM
Lastly, there is a subset of epidemiologic studies that assess whether long-term reductions in ambient PM
More specifically, of the accountability studies that account for changes in PM
The 2022 PA recognizes that there are a number of uncertainties and limitations associated with the available health effects evidence. Although the epidemiologic studies clearly demonstrate associations between long- and short-term PM
While studies using hybrid modeling methods have reduced exposure measurement error and uncertainty in the health effect estimates, these studies use a variety of approaches to estimate PM
Regardless of whether a study uses monitoring data or a hybrid modeling approach when estimating PM
In addition, where PM
Another area of uncertainty is associated with other potential confounders, beyond copollutants. Some studies have expanded the examination of potential confounders to not only include copollutants, but also systematic evaluations of the potential impact of inadequate control from long-term temporal trends and weather (U.S. EPA, 2019a, section 11.1.5.1). Analyses examining these covariates further confirm that the relationship between PM
Another important limitation associated with the evidence is that, while epidemiologic studies indicate associations between PM
Overall, evidence assessed in the 2019 ISA and ISA Supplement continues to indicate a linear, no-threshold C-R relationship for PM
There are also a number of uncertainties and limitations associated with the experimental evidence (
Consideration of health effects are informed by the epidemiologic, controlled human exposure, and animal toxicological studies. The evaluation and integration of the scientific evidence in the ISA focuses on evaluating the findings from the body of evidence across disciplines, including evaluating the strengths and weaknesses in the overall collection of studies across disciplines. Integrating evidence across disciplines can strengthen causal inference, such that a weak inference from one line of evidence can be addressed by other lines of evidence, and coherence of these lines of evidence can add support to a cause-effect interpretation of the association. Evaluation and integration of the evidence also includes consideration of uncertainties that are inherent in the scientific findings (U.S. EPA, 2015, pp. 13-15), some of which are described above.
Beyond the consideration of the scientific evidence, discussed above in section II.B, the EPA also considers the extent to which new or updated quantitative analyses of PM
Risk assessments combine data from multiple sources and involve various assumptions and uncertainties. Input data for these analyses includes C-R functions from epidemiologic studies for each health outcome and ambient annual or 24-hour PM
Concentration-response functions used in the risk assessment are from large, multicity U.S. epidemiologic studies that evaluate the relationship between PM
As described in more detail in the 2022 PA, the risk assessment first estimated health risks associated with air quality for 2015 adjusted to simulate “just meeting” the current primary PM
When selecting U.S. study areas for inclusion in the risk assessment, the available ambient monitors, geographic diversity, and ambient PM
In addition to the overall risk assessment, the 2022 PA also includes an at-risk analysis and estimates exposures and health risks of specific populations identified as at-risk that would be allowed under the current and potential alternative standards to further inform the Administrator's conclusions regarding the adequacy of the public health protection provided by the current primary PM
Uncertainty in risk estimates (
Similarly, the at-risk analysis is also subject to many of these same uncertainties noted above. Additionally, the at-risk analysis included C-R functions from only one study (Di et al., 2017b), which reported associations between long-term PM
Although limitations in the underlying data and approaches lead to some uncertainty regarding estimates of PM
Compared to the current annual standard, meeting a revised annual standard with a lower level is estimated to reduce PM
Revising the level of the 24-hour standard to 30 μg/m
In drawing conclusions on the adequacy of the current primary PM
The approach to reviewing the primary standards is consistent with requirements of the provisions of the CAA related to the review of the NAAQS and with how the EPA and the courts have historically interpreted the CAA. As discussed in section I.A above, these provisions require the Administrator to establish primary standards that, in the Administrator's judgment, are requisite (
The decisions on the adequacy of the current primary PM
Section II.B.2 below briefly summarizes the basis for the Administrator's proposed decision, drawing from section II.D.3 of the proposal (88 FR 5617, January 27, 2023). The advice and recommendations of the CASAC and public comments on the proposed decision are addressed below in sections II.B.1 and II.B.3, respectively. The Administrator's final conclusions in this reconsideration regarding the adequacy of the current primary PM
As part of its review of the 2019 draft PA, the CASAC provided advice on the adequacy of the public health protection afforded by the current primary PM
The CASAC members who supported retaining the current annual standard expressed the view that substantial uncertainty remains in the evidence for associations between PM
These members of the CASAC further concluded that the quantitative risk assessment included in the 2019 draft PA does not provide a valid basis for revising the current standards. This conclusion was based on concerns that (1) “the risk assessment treats regression coefficients as causal coefficients with no justification or validation provided for this decision;” (2) the estimated regression concentration-response functions “have not been adequately adjusted to correct for confounding, errors in exposure estimates and other covariates, model uncertainty, and heterogeneity in individual biological (causal) [concentration-response] functions;” (3) the estimated concentration-response functions “do not contain quantitative uncertainty bands that reflect model uncertainty or effects of exposure and covariate estimation errors;” and (4) “no regression diagnostics are provided justifying the use of proportional hazards . . . and other modeling assumptions” (Cox, 2019b, p. 9 of consensus responses). These committee members also contended that details regarding the derivation of concentration-response functions, including specification of the beta values and functional forms, were not well-documented, hampering the ability of readers to evaluate these design details. Thus, these members “think that the risk characterization does not provide useful information about whether the current standard is protective” (Cox, 2019b, p. 11 of consensus responses).
Drawing from their evaluation of the evidence and the risk assessment in the 2019 draft PA, these committee members concluded that “the Draft PM PA does not establish that new scientific evidence and data reasonably call into question the public health protection afforded by the . . . 2012 PM
In contrast, “[o]ther members of CASAC conclude[d] that the weight of the evidence, particularly reflecting recent epidemiology studies showing positive associations between PM
The members of the CASAC who supported revising the current annual standard particularly emphasized recent findings of associations with PM
As a part of this reconsideration, the CASAC reviewed the 2021 draft PA (developed to support the reconsideration as described in section I.C.5 above). As a part of their review of the 2021 draft PA, the CASAC provided advice on the adequacy of the current primary PM
In its comments on the 2021 draft PA, the CASAC stated that: “[o]verall the CASAC finds the Draft PA to be well-
With regard to the adequacy of the current primary annual PM
In reaching conclusions on a recommended range of 8-10 μg/m
In recommending a range of 10-11 μg/m
With regard to the current primary 24-hour PM
As noted above, the majority of the CASAC favored revising the level of the primary 24-hour PM
The minority of the CASAC agreed with the EPA's preliminary conclusion in the 2021 draft PA to retain the current primary 24-hour PM
While the CASAC members expressed differing opinions on the appropriate revisions to the current standards, they did “find that both primary standards, 24-hour and annual, are critical to protect public health given the evidence on detrimental health outcomes at both short-term and long-term exposures including peak events” (Sheppard, 2022a, p. 13 of consensus responses). The comments from the CASAC also took note of uncertainties that remain in this reconsideration of the primary PM
In reaching his proposed decisions to revise the level of the primary annual PM
In reaching his proposed conclusions on whether the currently available scientific evidence and quantitative risk-based information support or call into question the adequacy of the public health protection afforded by the current primary PM
The Administrator's full rationale for his proposed conclusions is presented in section II.D.3 of proposal (88 FR 5658, January 27, 2023), but is also briefly summarized here. In reaching the proposed decision to revise the annual standard level to 9-10 µg/m
The Administrator also recognized that epidemiologic studies provide the strongest scientific evidence when evaluating the adequacy of the level of the annual standard. He noted that there is no specific point in the air quality distribution of any epidemiologic study that represents a `bright line' at and above which effects have been observed and below which effects have not been observed. In his proposed decision, he noted previous decision-making frameworks, which placed weight on values at or near the study-reported mean PM
In reaching his proposed decision, the Administrator noted that a level of 9-10 µg/m
The Administrator took note of additional pieces of scientific evidence, which were not available in previous reviews, including restricted analyses, which support that the association seen in epidemiologic studies does not just occur from the peaks of the exposure distribution. Additionally, he notes that a level of 9-10 µg/m
Further, the Administrator took into consideration the advice of the CASAC, noting that all members included 10 µg/m
In reaching the proposed conclusion of a range between 9-10 µg/m
As such, the Administrator's proposed decision noted that the current PM
In his proposed decision to retain the current primary 24-hour PM
The Administrator also noted that as, in previous PM NAAQS reviews, the protection provided by the suite of standards (
Additionally, the Administrator proposed to conclude that it is appropriate to retain all other elements (
With respect to the adequacy of the primary annual PM
In contrast, other commenters, primarily from public health and environmental organizations, some State and local elected representatives, and some State and local government agencies agree with the EPA's proposed decision that the primary annual PM
The EPA agrees with commenters that the primary annual PM
Additionally, as discussed in more detail in section I.C.5.b above, the ISA Supplement focused on studies that were most likely to inform decisions on the appropriate standard, but not to reassess areas that, based on the assessment of available science published since the cutoff date of the 2019 ISA and through 2021, were judged unlikely to have new information that would be useful for the Administrator's decision making. The ISA Supplement included U.S. and Canadian epidemiologic studies for health effect categories where the 2019 ISA concluded a causal relationship (
In addition, there are epidemiologic studies that provide supplemental information for consideration in reaching conclusions that the current suite of PM
Thus, in considering the available scientific evidence to inform conclusions on the adequacy of the primary PM
In addition to the scientific evidence above, the risk assessment estimates that the current primary annual PM
In the CASAC's review of the 2019 draft PA, the CASAC did not reach consensus on whether the current annual standard is adequate, with the majority of the CASAC recommending that the annual standard be retained and the minority of the CASAC recommending that the standard be revised. In their review of the 2021 draft PA, the CASAC unanimously recommended that the current annual standard is not sufficiently protective of public health (Sheppard, 2022a, p. 2 of consensus letter).
The EPA disagrees with the commenters who state that the available scientific and quantitative information available in this reconsideration does not provide support for the current Administrator to reach a different decision than the then-Administrator reached in the 2020 final action. The EPA agrees with these commenters that there are uncertainties associated with the currently available scientific evidence. The EPA has considered these uncertainties extensively both in reaching conclusions in the 2022 PA (U.S. EPA, 2022b, sections 3.4.3, 3.6.1, and 4.6.3) and in the proposal (88 FR 5604, 5609, January 27, 2023), and the EPA addresses more detailed public comments about these uncertainties, including those related to copollutant confounding, unmeasured confounding, and temporal and spatiotemporal confounding, in the Response to Comments document. However, we disagree with the commenters that the evidence does not provide support for the Administrator's conclusion that the current primary annual PM
Additionally, this reconsideration includes epidemiologic studies that were not before the then-Administrator for consideration in reaching his final decisions at the time of the 2020 decision and that specifically evaluate
Further, the EPA disagrees with the commenters who argue that the Administrator did not appropriately consider the strengths and limitations of the health evidence in reaching his decision to revise the current primary annual PM
Additionally, the EPA disagrees with the commenters that contend that there is no basis in this reconsideration for deviating from the previous Administrator's decision in 2020. It is well-established that in CAA section 109 Congress specifically left the determination of the requisite NAAQS to the judgment of the Administrator and, moreover, that “decisions about the appropriate NAAQS level must `necessarily . . . rest largely on policy judgments.' ”
In this reconsideration, both the existing corpus of scientific knowledge as well as the Administrator's policy judgments about how to interpret and weigh that evidence to protect public health with an adequate margin of safety have changed. The expansion of the air quality criteria to encompass additional studies, information and analyses in the ISA Supplement and 2022 PA, as well as the additional consideration of the scientific record by the CASAC and the public provided the Administrator with significant additional information on which to base his decision.
As such and further detailed in section II.B.4 below, in considering the adequacy of the current primary PM standards in this reconsideration, the Administrator has carefully considered the: (1) Policy-relevant evidence and conclusions contained in the 2019 ISA and 2022 ISA Supplement; (2) the quantitative information presented and
The four basic elements of the NAAQS (indicator, averaging time, form, and level) are considered collectively in evaluating the health protection afforded by a standard. The EPA received relatively few comments on the averaging time and form for the primary PM
The EPA disagrees with commenters that the current primary 24-hour PM
As noted in the proposal, the 2019 ISA and ISA Supplement found that the scientific evidence continues to provide strong support for health effect associations with both long-term (
Multiple commenters, primarily from public health and environmental organizations, recommend revising the form of the primary 24-hour PM
The EPA disagrees that the current 98th percentile form does not provide the requisite public health protection against peak PM
Additionally, the EPA recognizes the CASAC's advice in their review of the 2021 draft PA, where they recommended “that in future reviews, the EPA provide a more comprehensive assessment of the 24-hour standard that includes the form as well as the level” (Sheppard, 2022a, p. 4 of consensus letter). This advice is reflected in the proposal by the EPA, which noted “that it would be appropriate to gather additional air quality and scientific information and further consider these issues in future reviews” (88 FR 5619, January 27, 2023). The EPA will consider the information provided by the commenters regarding the form of the 24-hour PM
A number of commenters who support revising the level of the primary annual PM
As an initial matter, consistent with some previous approaches and as detailed by the Administrator in reaching conclusions on the level of the primary annual PM
In considering the available scientific evidence to reach decisions on the adequacy of the suite of primary PM
In considering the available scientific evidence, the EPA notes the strength of the epidemiologic evidence which includes multiple studies that consistently report positive associations for short- and long-term PM
While these epidemiologic studies evaluate associations between distributions of ambient PM
Studies of daily PM
Based on the air quality criteria for this reconsideration, as described in the 2019 ISA, ISA Supplement, 2022 PA and the proposal, the EPA believes it is appropriate to continue to use the mean PM
There are a large number of key epidemiologic studies available in this reconsideration to inform conclusions regarding the level of the primary annual PM
In addition to the study-reported mean PM
The key U.S. epidemiologic studies that report percentiles below the mean that are monitor based are older studies. These studies included smaller numbers of people than the newer hybrid model-based studies. For the three older, monitor-based studies, because the cohorts were smaller in size, a relatively smaller portion of the health events were observed in the lower part of the air quality distribution. As such, our confidence in the magnitude and significance of the associations begins to decrease in the lower part of the air quality distribution of those older, monitor-based studies.
The three newer, hybrid model-based studies have larger cohort sizes than the older, monitor-based studies and, as noted by commenters, have more health events in the lower part of the air quality distribution. For these reasons, the EPA notes that we have more confidence in the reported association at concentrations lower than the reported mean in these more recent hybrid model-based studies, particularly at the 25th percentile compared to the 10th percentile. While the cohort sizes in the more recent, hybrid model-based studies are larger than the older, monitor-based studies, the EPA notes that the 10th percentiles are well below the middle portion of the air quality distribution for which we have the greatest confidence, and as noted above, our confidence in the magnitude and significance of associations in the lower parts of the air quality distribution begins to decrease. While we have more confidence in the lower percentiles because of the larger cohort sizes in the more recent hybrid model-based studies, we also have more confidence in the 25th percentiles than in the 10th percentiles, which are further from the means and closer to the lower end of the air quality distribution.
In considering how the six studies that report percentiles lower than the mean can be used to inform conclusions regarding the level of the primary annual PM
Some commenters disagree with the EPA's consideration of the relationship between mean PM
To the extent that commenters are suggesting that the EPA is setting the level of the primary annual PM
However, the EPA notes that it is important to understand, and to not ignore, the relationship between the study-reported mean PM
In considering the annual standard, and in assessing the range of study-reported exposure concentrations for which we have the strongest support for adverse health effects observed in epidemiologic studies, the EPA focuses on whether the current primary annual PM
The relationship between the mean PM
However, as described in section II.A.2.c.ii, we note that there are a substantial number of different types of epidemiologic studies available since the 2012 review, as assessed in both the 2019 ISA and the ISA Supplement, that make understanding the relationship between the mean PM
To emphasize the importance of the differences between the studies, we revisit the simplified example in the State of Georgia from the 2022 PA that evaluates monitors and hybrid modeling approaches, noting that this example is useful to exhibit how the differences in the methods used to estimate exposure can lead to differences in the reported mean concentrations (U.S. EPA, 2022b, p. 3-71). In this example, for all monitors within the Atlanta-Sandy Springs-Roswell CBSA, the average PM
As detailed above in section I.D.5, in the air quality analyses comparing composite monitored PM
Air quality analyses described in section I.D.5 above also consider information from the epidemiologic studies that utilized the hybrid modeling approaches. Analyses show that average maximum annual design values are 40-50% higher when compared to annual average PM
Because of the differences in the methods employed by the key epidemiologic studies, and as demonstrated by the example and air quality analyses above, the application of any decision framework that considers the study-reported mean PM
In considering the information from the epidemiologic studies, while the EPA does not dispute the reported associations of epidemiologic studies in hybrid modeling studies that report long-term mean concentrations and do not apply aspects of population weighting, using the reported long-term mean concentration from these studies in informing an appropriate level of the annual PM
In considering the relationship between study-reported mean PM
Additionally, the EPA disagrees with commenters who contend that the approach taken may allow PM
Several commenters assert that epidemiologic studies that restrict PM
First, the EPA agrees with commenters that studies that employ restricted analyses can be used for informing conclusions regarding the appropriate level of the primary annual PM
As described in reaching his conclusions in the section below, the Administrator judges that, despite these uncertainties and limitations, studies that use restricted analyses can provide supplemental information for consideration in reaching conclusions regarding both the adequacy and level of the standard. He notes two studies (Di et al., 2017b and Dominici et al., 2019) are available in this reconsideration that report means in their restricted analyses (restricting annual average PM
We disagree with the commenters that concerns about relating the mean PM
Several commenters contend that in considering the accountability studies, the EPA inappropriately reached conclusions regarding the level of the primary annual PM
Accountability studies examine the effect of a policy on reducing PM
Commenters disagree with the Administrator placing less weight on the epidemiologic studies conducted in Canada when reaching conclusions regarding the level of the primary annual PM
In considering the information from the epidemiologic studies in reaching his conclusions, the Administrator considered the full body of evidence, including studies conducted in the U.S. and Canada. However, as described in the proposal and in section II.B.4 below, the Administrator also recognizes that the exposure environments in the U.S. are different from those in Canada. In particular, the U.S. population density is approximately 43 people per square kilometer in the contiguous U.S.
With respect to the CASAC's advice in their review of the 2021 draft PA, the EPA recognizes that the majority of the CASAC pointed to the Canadian studies as supporting their recommendation to revise the annual standard level to within the range of 8-10 µg/m
Lastly, the EPA disagrees with commenters that the findings of the Canadian epidemiologic studies can be directly translated into a primary annual PM
Commenters who supported retaining and revising the primary annual PM
Conversely, commenters who support revising the standard assert that the at-risk analyses conducted in the 2022 PA provide support for revising the primary annual PM
As discussed in section I above, the primary (health-based) NAAQS are established at a level that is requisite to protect public health, including the health of sensitive or at-risk groups, with an adequate margin of safety.
The Administrator expressly considered the available information regarding health effects among at-risk populations in reaching the proposed decisions that the current primary annual PM
With respect to the risk assessment, while the EPA notes that the analyses support the conclusion that the primary PM
The same is true for the new at-risk analysis in the risk assessment presented in the 2022 PA that is based on a recent epidemiologic study that is available in this reconsideration that provides mortality risk coefficients for older adults (
While there are substantial uncertainties in the absolute results of the quantitative risk assessment, the EPA also notes that recent scientific evidence evaluated in the ISA Supplement, which built upon the 2019 PM ISA conclusions, found that the evidence “[c]ontinue[s] to support disparities in PM
In conclusion, the EPA recognizes that the at-risk analysis was based on one epidemiologic study that stratified by race/ethnicity for older adults (
A number of commenters, primarily from industries and industry groups and some States, support the EPA's proposed decision to retain the primary 24-hour PM
A number of commenters, primarily from public health and environmental organizations and some States, oppose the EPA's proposed decision to retain the primary 24-hour PM
As an initial matter, the EPA disagrees with commenters who suggest that decisions regarding the primary 24-hour PM
Regarding the appropriate basis for determining the level of the 24-hour standard, a number of commenters who support revising the primary 24-hour PM
Other commenters support the EPA's use of the controlled human exposure studies to inform the adequacy of the public health protection and note that the 24-hour standard must at least provide protection against the health effects observed in controlled human exposure studies. Some of the commenters cite the Wyatt et al. (2020) study that demonstrated cardiovascular effects following 2-hour exposures to 120 µg/m
Additionally, other commenters assert that the EPA should focus less on peak PM
The EPA generally disagrees with commenters who contend that it is inappropriate to rely on the controlled human exposures studies in evaluating the adequacy of the public health protection afforded by the primary 24-hour PM
The EPA notes that the majority of the CASAC, in their review of the 2021 draft PA, commented that these controlled human exposure studies generally do not include populations with substantially increased risk from exposure to PM
The EPA agrees with the CASAC that the controlled human exposure studies generally do not include populations with substantially increased risk from exposure to PM
The EPA agrees with commenters that the primary 24-hour PM
The EPA did receive multiple comments questioning these results and the approach in the EPA's analyses. For example, some commenters submitted an analysis of monitoring data from 2017-2020, which compares the number of days per year where maximum daily PM
First, the EPA notes that this analysis submitted by commenters was limited to a very small number of monitors and did not include a national perspective. Second, the EPA notes that this analysis focused on number of days (rather than the number of times) where there was a 2-hour maximum concentration over 120 µg/m
In evaluating the results from the new analyses, it is important to keep in mind that the 2019 ISA and ISA Supplement concluded that the most consistent evidence from the controlled human exposures studies is for impaired vascular function following 2-hour exposures to average PM
Additionally, the analyses also evaluated the frequency of reporting a 4-hour maximum concentration over 37.8 µg/m
In response to commenters that cited the majority of the CASAC's view that, in general, “[t]here is . . . less confidence that the annual standard could adequately protect against health effects of short-term exposures” (Sheppard, 2022a, p. 4 of consensus letter), the EPA disagrees with the majority of CASAC, noting that the results of the EPA's analysis suggest that high peak concentrations are extremely infrequent in areas meeting an annual standard of 9.0 µg/m
A number of commenters who support revising the primary 24-hour PM
These commenters highlight a number of specific epidemiologic studies that they suggest provide support for revising the level of the 24-hour standard. Additionally, commenters contend that there are epidemiologic studies using restricted analyses that show that positive and statistically significant associations between short-term PM
As noted by the commenters, epidemiologic studies that show positive and statistically significant associations between short-term PM
However, findings of positive, significant associations in short-term epidemiologic studies do not directly indicate that short-term effects would occur in areas meeting the 24-hour standard and therefore, do not directly address the question of whether the current 24-hour standard is adequate. While short-term epidemiologic studies evaluate associations between distributions of ambient PM
As noted above, in evaluating the adequacy of the current standards, the EPA has consistently considered the annual standard (based on arithmetic mean concentrations) and 24-hour standard (based on 98th percentile concentrations) together in evaluating the public health protection provided by the standards against the full distribution of short- and long-term PM
Short-term epidemiologic studies, including those that use restricted analyses, often report metrics that include mean PM
With regard to the data that are available from the short-term epidemiologic studies (which, as noted, do not include 98th percentile values), the EPA considers it inappropriate to utilize the study-reported means from the short-term epidemiologic evidence to assess the adequacy of the 24-hour standard, with its 98th percentile form, considering that the study-reported mean concentrations do not provide meaningful insight regarding the frequency or health significance of peak concentrations occurring during the study period. As indicated in the 2022 PA, the study-reported means of short-term epidemiologic studies do not serve a purpose in determining a level at which we can confidently attribute effects to the impact of “peak” exposures. The 24-hour standard is intended to provide supplemental protection against short-term peak exposures and while there is a general relationship between mean concentrations and 98th percentile concentrations in individual locations, such relationships vary by location and there is not an established relationship that can be relied upon to predict 98th percentile concentrations based on mean PM
As described in the proposal (88 FR 5613, January 27, 2023), the 2022 PA also noted the epidemiologic studies that restrict 24-hour average PM
In their review of the 2021 draft PA, the majority of the CASAC highlighted three U.S.-based epidemiologic studies that restricted 24-hour average PM
Further, these restricted analyses do not report the PM
Further, the EPA notes that when resulting analyses based on the
Due to the limitations and uncertainties outlined above, in reaching his decision on the primary 24-hour PM
This section summarizes the Administrator's considerations and conclusions related to the adequacy of the current primary PM
Given these requirements, the Administrator's final decision in this reconsideration is a public health policy judgment drawing upon scientific and technical information examining the health effects of PM
The initial issue to be addressed in the reconsideration of the primary PM
In evaluating the adequacy of the current standards, the Administrator first recognizes the longstanding body of health evidence supporting relationships between PM
In evaluating what existing or revised standards may be requisite to protect public health, as described above in section II.A.2, the Administrator's approach recognizes that the current annual standard (based on arithmetic mean concentrations) and 24-hour standard (based on 98th percentile concentrations), together, are intended to provide public health protection against the full distribution of short- and long-term PM
Further, consistent with the approach adopted in 2012, the Administrator concludes that the most effective and efficient way to reduce total population risk associated with both long- and short-term PM
In light of his focus on the annual standard as the generally controlling standard, in considering whether the primary PM
With regard to the available scientific evidence to inform his final decisions on the adequacy of the current 24-hour standard, the Administrator finds that there is less information available to support decisions on the 24-hour standard than that summarized above for the annual standard. The Administrator first notes that controlled human exposure studies, including those newly available in this reconsideration, demonstrate effects following short-term PM
In addition to the scientific evidence, the Administrator also considers the information from the risk assessment. In so doing, he notes that the risk assessment estimates that the current primary annual PM
In reaching his final conclusions regarding the adequacy of the primary PM
The Administrator recognizes that much of the scientific evidence available in this reconsideration was also available in the 2019 ISA and was considered by the then-Administrator when he decided that the current primary PM
In considering the available information in this reconsideration, the current Administrator reached different conclusions regarding the appropriate weight to place on certain aspects of the evidence than the then-Administrator in the 2020 final decision. For example, in reaching his conclusions on the primary annual PM
In addition to adopting a different approach than the previous Administrator for considering the long-term mean PM
In this reconsideration, the current Administrator notes that the ISA Supplement evaluates additional studies that employed statistical approaches that attempted to more extensively account for confounders and are more robust to model misspecification (
In reaching this final decision, the Administrator recognizes he is differing not only with the prior Administrator but also with the advice some members of the CASAC provided during their review of the 2019 draft PA. Specifically, taking into consideration the strength of the evidence providing support for causality determinations, the advice of other members of the CASAC and the need to protect public health with an adequate margin of safety, the current Administrator disagrees with these members of CASAC regarding the weight to be given to epidemiologic evidence “based on its methodological limitations” (Cox, 2019b, p. 8 of consensus responses), such as the possibility “that such associations could reasonably be explained by uncontrolled confounding and other potential sources of error and bias” (Cox, 2019b, p. 8 of consensus responses).
As another example of information that was not available to the CASAC in providing advice to the Administrator in reaching his final decision in 2020, the then-Administrator noted in his final decision that, while some members of the CASAC and public commenters highlighted a number of accountability studies that examined past reductions in ambient PM
As EPA has frequently noted throughout this document, the extent to which the current primary PM
Based on the available scientific evidence and quantitative information, as well as consideration of the CASAC's advice and public comments, the Administrator concludes that the
In considering how to revise the current suite of primary PM
Consistent with his proposed conclusions regarding averaging time, the Administrator notes that the scientific evidence continues to provide strong support for health effect associations with both long- and short-term PM
With regard to form, the Administrator first notes that the EPA has set both an annual standard and a 24-hour standard to provide protection from health effects associated with both long- and short-term exposures to PM
With regard to the form of the 24-hour standard (98th percentile, averaged over three years), epidemiologic studies continue to provide strong support for health effect associations with short-term (
The Administrator also recognizes that the CASAC recommended that in future reviews, the EPA also consider alternative forms for the primary 24-hour PM
In considering how to revise the current suite of PM
The Administrator's decision to revise the level of the primary annual PM
Given his consideration of the scientific evidence, quantitative risk information, advice from the CASAC, and public comments, the Administrator judges that a primary annual PM
Consistent with his conclusions on the need for revision of the current annual standard, in reaching a decision on level, the Administrator places the most weight on information from epidemiologic studies. In so doing, the Administrator notes that these studies provide consistent evidence of positive and statistically significant associations between long- and short-term exposure to PM
As at the time of proposal, the Administrator notes that some recent epidemiologic studies have adopted a broad range of approaches to examine confounding and the results of those examinations support the robustness of reported associations seen in epidemiologic studies. These include studies that employ alternative methods for confounder control and studies that evaluate the uncertainty related to exposure measurement error, both of which continue to support associations between PM
In considering the epidemiologic evidence, the Administrator judges that, in reaching his decision on an appropriate level for the annual standard that will protect public health with an adequate margin of safety, in the absence of any discernible population-level thresholds, and in recognizing the need to weigh uncertainties associated with the epidemiologic evidence, it is most appropriate to examine where the evidence of associations observed in the
Additionally, the Administrator acknowledges that in the 2020 final action, the then-Administrator decided to retain the standard based in part on concerns about placing reliance on the epidemiologic studies and his judgment that even if he did rely on them, the majority of the studies had means or medians, as well as the mean of all of the key study-reported means or medians, above the level of the current annual standard. However, after considering the evidence, the advice of CASAC, and public comments the Administrator judges that this approach is insufficient to protect public health with an adequate margin of safety. The Administrator's decision to reach a different judgment about the appropriate level of the annual standard reflects the updated and expanded scientific record available to the Administrator in this reconsideration, as well as the additional advice from the CASAC and the public comments based on this newly available information. In addition, the Administrator observes the decision in this action to place weight on the epidemiologic studies, and to revise the annual primary standard to a level below the lowest long-term mean in the U.S.-based epidemiologic studies, is consistent with the EPA's past practice in PM NAAQS reviews.
In this reconsideration, the Administrator is considering the scientific record which has been expanded and updated since the 2020 final action, as well as the additional advice from the CASAC and the public comments that are based on the newly available information that expands upon the information previously available. In addition, the Administrator is exercising his judgment about how to interpret and weigh the expanded evidence in a way that is more consistent with the approaches used in prior PM NAAQS reviews. As a result, the Administrator has concluded on reconsideration that the level of the primary annual standard is not adequate and should be revised to protect public health with an adequate margin of safety.
Consistent with his proposed decisions, in reaching conclusions on the level of the primary annual PM
In adopting such an approach, the Administrator considers the long-term mean concentrations reported in two types of key epidemiologic studies: (1) Monitor-based studies
Based on this information, and in considering the CASAC's advice in their review of the 2021 draft PA, the Administrator judges that it is appropriate to set the level of the primary PM
As noted above, however, the Administrator must exercise his judgment regarding the appropriate weight to place on the available scientific evidence and quantitative information, including uncertainties, in determining what level of the annual standard is sufficient to protect public health with an adequate margin of safety. In so doing, he considers other information available in this reconsideration to inform his judgments, including study-reported PM
In weighing the evidence in considering the requisite level of the annual standard, the Administrator also takes into account additional information from the key long- and short-term U.S. epidemiologic studies available that provide study-reported PM
In considering the information from these studies, as described in section II.A.2.c and in responding to public comments in section II.B.3 above, the Administrator notes that there are two hybrid model-based studies with large cohort sizes that apply population weighting and report lower percentile values. These studies are Di et al. (2017b) and Wang et al. (2017) and the reported 25th percentile concentration is 9.1 µg/m
As at the time of proposal, the Administrator also takes note of the study-reported long-term mean PM
Thus, the Administrator considers the Canadian studies to inform his judgments on what level for the annual standard is requisite in light of the limitations and challenges presented. The Administrator also recognizes that the majority of the CASAC in their review of the 2021 draft PA, as well as a number of public commenters, place weight on the Canadian epidemiologic studies in recommending that the level of the primary annual PM
The Administrator also recognizes that information from epidemiologic studies that included analyses that restrict annual average PM
The Administrator also recognizes that, in their review of the 2021 draft PA, the CASAC noted that epidemiologic studies that restrict analyses below certain PM
The Administrator also takes into consideration recent U.S. accountability studies, which assess the health effects associated with actions that improve air quality (
In addition to his consideration of and conclusions regarding the available scientific evidence, the Administrator also considers the results of the quantitative risk assessment to inform his conclusions regarding the appropriate level for the primary annual PM
Additionally, with respect to the results of the quantitative risk assessment, the Administrator recognizes that the 2022 PA also provides information on the distribution of concentrations associated with the estimated mortality risk at each alternative standard level assessed (U.S. EPA, 2022b, sections 3.4.2.2 and 3.6.2.2, Figure 3-18 and 3-19). When meeting an annual standard of 9.0 µg/m
The Administrator also notes the information provided by the quantitative risk assessment on the distribution of concentrations associated with the estimated mortality risk for a higher annual standard level of 10.0 µg/m
Recognizing and building upon the above considerations and judgments, and with consideration of advice from the CASAC and public comment, the Administrator concludes that the current body of scientific evidence and quantitative risk assessment support his judgment that the level of the primary annual PM
The Administrator recognizes that placing weight on the information from the epidemiologic studies allows for examination of the entire population, including those that may be at comparatively higher risk of experiencing a PM
Furthermore, the Administrator recognizes the CASAC's advice in their review of the 2021 draft PA, as well as public comments, that weight should be placed on study-reported PM
The Administrator also takes note of the study-reported long-term mean PM
Additionally, the Administrator also considers the information provided by epidemiologic studies that use restricted analyses, as well as accountability studies. With respect to the restricted analyses, the Administrator, in considering the CASAC's advice in their review of the 2021 draft PA and many public comments on these types of studies, concludes that, although there are inherent uncertainties associated with this limited body of evidence, the studies that apply restricted analyses provide support for serious effects (
The Administrator also judges that the results of the quantitative risk assessment provide support for a primary annual PM
When considering adequate margin of safety, the Administrator notes that in his decision to revise the annual standard level to 9.0 µg/m
In reaching this conclusion, the Administrator recognizes that in establishing primary standards under the Act that are requisite to protect public health with an adequate margin of safety, he is seeking to establish standards that are neither more nor less stringent than necessary for this purpose. The Act does not require that primary standards be set at a zero-risk level or to protect the most sensitive individual, but rather at a level that avoids unacceptable risks to public health. In this context, the Administrator's conclusion is that revised primary annual standard, in conjunction with the 24-hour standard, provides the appropriate degree of protection, and that more or less stringent standards would not be requisite.
In considering the requirement for an adequate margin of safety, the Administrator notes that the determination of what constitutes an adequate margin of safety is expressly left to the judgment of the EPA Administrator.
Given all of the evidence and information discussed above, the Administrator judges that a standard with a level of 9.0 µg/m
Additionally, in considering a less stringent standard, the Administrator recognizes that through its control of long- and short-term PM
Having concluded that a less stringent standard would not provide the requisite protection of public health, the Administrator next considers whether a more stringent standard would be appropriate. In so doing, he notes that a decision to set the level of the annual standard to below 9.0 µg/m
Thus, having carefully considered the scientific evidence, quantitative information, CASAC advice, and public comments relevant to his decision on the level of the primary annual PM
In reaching his conclusions on adequacy of the current suite of primary PM
In reaching his conclusion to retain the current primary 24-hour PM
Thus, the Administrator considers what primary 24-hour PM
In considering the available scientific evidence assessed in the 2019 ISA and ISA Supplement, the Administrator first considers the controlled human exposure studies for informing his decisions on the primary 24-hour PM
Consistent with his approach in reaching his proposed decision and taking into consideration these points as well as balancing these limitations (
Further, in light of the Administrator's emphasis on the annual standard as the controlling standard, with the 24-hour standard providing supplemental protection against peak concentrations, he next considers the potential impact of a revised annual standard of 9.0 µg/m
In addition, the Administrator also notes that the majority of the CASAC in their review of the 2021 draft PA, as well as a number of public commenters, support their recommendation to revise the current 24-hour standard by pointing to “substantial epidemiologic evidence from both morbidity and mortality studies” which “includes three U.S. air pollution studies with analyses restricted to 24-hour concentrations below 25 μg/m
However, the Administrator also notes significant limitations in the currently available epidemiologic information that limit his ability to draw conclusions from the key short-term studies, including those that employ restricted analyses, to inform his decision regarding the level of the 24-hour PM
First, he notes that short-term epidemiologic studies examine associations between day-to-day variations in PM
Similarly, the Administrator does not consider the results of the restricted analyses to be well suited to informing the choice of level for a 24-hour standard. Restricted analyses use a subset of data from their main analyses to evaluate health events that occur at concentrations below a certain concentration (
In reaching final decisions regarding the adequacy of the primary 24-hour PM
In selecting the level of a 24-hour standard designed to provide supplemental protection against peak exposures (in conjunction with a revised annual standard of 9.0 µg/m
He notes in particular that, in the EPA's analysis, in areas meeting the current 24-hour standard and the revised annual standard 0.029 percent of 2-hour observations and 0.41 percent of 4-hour observations reach PM
In addition to the scientific evidence, the Administrator also considers the risk assessment in evaluating the appropriate level of the 24-hour PM
In considering the application of the risk assessment to judgments about the adequacy of the current primary 24-hour PM
The Administrator also considers the advice from the CASAC in their reviews of the 2019 draft PA and 2021 draft PA. In their review of the 2019 draft PA, the CASAC “agrees with the EPA and finds that the available evidence does not call into question the adequacy of public health protection afforded by the current 24-hour PM
In considering the advice of the majority of CASAC, the Administrator notes that a decision to set the level of the 24-hour standard to below 35 µg/m
Thus, having carefully considered the scientific evidence, quantitative information, CASAC advice, and public comments, the Administrator is retaining the current primary 24-hour PM
In making this decision to retain the current level of the primary PM
For the reasons discussed above, and taking into account the information and assessments presented in the 2019 ISA and ISA Supplement, the scientific and quantitative risk information in the 2022 PA, the advice and recommendations of the CASAC, and public comments, the Administrator revises the current suite of primary PM
This section presents the rationale for the Administrator's decision to retain the existing primary PM
In presenting the rationale for the Administrator's final decision and its foundations, Section III.A provides background on the 2020 final decision to retain the primary PM
The general approach for this reconsideration of the 2020 final decision on the primary PM
Consistent with the 2009 ISA, the 2019 ISA concluded that the available epidemiologic, controlled human exposure, and animal toxicological studies, including uncertainties, provided support for the causality determinations of “suggestive of, but not sufficient to infer, a causal relationship” between short-term exposures to PM
Compared to the 2009 ISA, the 2019 ISA includes expanded evidence for the relationships between long-term exposures and cardiovascular effects, metabolic effects, nervous system effects, cancer, and mortality. The 2019 ISA concluded that the small number of epidemiologic and experimental studies, including uncertainties, contribute to the determination that, “the evidence is suggestive of, but not sufficient to infer, a causal relationship between long-term PM
In considering the available body of evidence, it was noted in the 2020 review there were considerable uncertainties and limitations associated with the experimental evidence for PM
• The potential for confounding by copollutants, notably PM
• There was greater spatial variability in PM
• Estimation of PM
There was relatively little information available to characterize potential exposure differences that may inform the apparent variability in associations between short-term PM
In reaching his decision in 2020 to retain the existing 24-hour primary PM
With regard to the evidence on PM
The information summarized here is based on the scientific assessment of the health effects evidence available in this reconsideration; this evaluation is documented in the 2019 ISA and its policy implications are discussed further in the 2022 PA. As noted above, the ISA Supplement does not include an evaluation of studies for PM
For the health effect categories and exposure duration combinations evaluated, the 2019 ISA concludes that the evidence supports causality determinations for PM
Due to the dearth of studies examining the association between long-term PM
With regard to short-term PM
In the 2009 ISA, the evidence describing the relationship between long-term exposure to PM
The evidence relating long-term PM
With regard to short-term PM
The evidence for short-term PM
With regard to short-term PM
Recent epidemiologic findings consistently link PM
In the 2012 review, little information was available from studies of cancer following inhalation exposures to PM
Taken together, the small number of epidemiologic and experimental studies, along with uncertainty with respect to exposure measurement error, contribute to the determination in the 2019 ISA that, “the evidence is suggestive of, but not sufficient to infer, a causal relationship between long-term PM
The 2009 ISA did not make a causality determination for PM
The 2009 ISA did not make a causality determination for PM
In drawing conclusions on the adequacy of the current primary PM
As described in section I.X, the EPA decided to prepare a revised PA for the reconsideration of the 2020 final decision. The CASAC's advice on the 2019 draft PA and the 2021 draft PA was documented in letters to the prior and current Administrators (Cox, 2019b; Sheppard, 2022a) and is summarized below. In reviewing both the 2019 draft PA and the 2021 draft PA, the CASAC agreed with the EPA's preliminary conclusion that the available scientific evidence, including its uncertainties and limitations, does not call into question the adequacy of the current primary PM
In its review of the 2019 draft PA, the CASAC concurred with the overall preliminary conclusion that it is appropriate to consider retaining the current primary PM
In its review of the 2021 draft PA, the CASAC provided advice on the adequacy of the current primary PM
The CASAC recommended several areas for additional research to reduce uncertainties in the PM
At the time of the proposal, the Administrator carefully considered the assessment of the current evidence and conclusions reached in the 2019 ISA, considerations and staff conclusions and associated rationales presented in the 2020 PA and 2022 PA, and advice and recommendations of the CASAC (88 FR 5634, January 27, 2023). Consistent with previous reviews, the Administrator first considered the available scientific evidence for PM
In reaching his proposed decision on the adequacy of the current primary 24-hour PM
When considering the above information together, the Administrator proposed to conclude that the available scientific evidence continues to support a PM
Of the public comments received on the proposal, very few commenters provided comments on the primary PM
Some commenters, including those from environmental and public health organizations and groups, some states, and individuals, disagreed with the Administrator's proposed decision to retain the current primary PM
Commenters who disagreed with the proposal to retain the current standard state that revision to the primary PM
We disagree with the commenters that the primary PM
The 2019 ISA provides a comparison of the relative contribution of PM
The EPA recognizes that when the primary annual PM
Beyond the uncertainties and limitations associated with the available scientific evidence, the EPA also notes that, while the NCore monitoring network has been expanded since the time of the last review, epidemiologic studies available in this review do not use PM
Consistent with their comments on the 2020 proposal, some commenters disagreed with the Administrator's proposed conclusion to retain the current primary PM
First, the EPA has long recognized that the form is an integral part of the NAAQS and must be selected together with the other elements (
Even if the commenters had asked that the change in form be made without regard to monitoring method, the EPA does not believe such a change would be warranted. The change in form for continuous monitors suggested by the commenters, without also lowering the level of such a standard, would allow more exceedances and thereby reduce the public health protection provided against exposures to PM
With regard to the commenters' assertion that an alternate form of the standard would ease the burden of demonstrating exceptional events, the EPA recognizes, consistent with the CAA, that it may be appropriate to exclude monitoring data influenced by “exceptional” events when making certain regulatory determinations. However, the EPA notes that the cost of implementation of the standards may not be considered by the EPA in reviewing the standards. The EPA continues to update and develop documentation and tools to facilitate the implementation of the 2016 Exceptional Events Rule, including new PM
This section summarizes the Administrator's considerations and conclusions related to the current primary PM
Given these requirements, and consistent with the primary PM
Having carefully considered advice from the CASAC and public comments, as discussed above, the Administrator notes that the fundamental scientific conclusions on health effects of PM
As noted below, the scientific evidence for PM
In reaching his conclusions on the primary PM
The Administrator also notes that the scientific record for his decision on the primary PM
With regard to the indicator for the primary PM
Similarly, with regard to averaging time, form, and level of the standard, the Administrator takes note of uncertainties in the available evidence and information and continues to find that the current standard, as defined by in all of its elements, is requisite. As an initial matter, the Administrator notes that the current primary PM
For the reasons discussed above and considering information and assessments presented in the 2019 ISA and the 2022 PA, the advice from the CASAC, and public comments, the Administrator concludes that the current primary PM
Information about the public health implications of ambient concentrations of criteria pollutants is communicated to the public using the Air Quality Index (AQI) reported on the EPA's AirNow website.
The AQI converts an individual pollutant concentration in a community's air to a number on a scale from 0 to 500. Reported AQI values for specific pollutants enable the public to know whether air pollution levels in a particular location are characterized as good (0-50), moderate (51-100), unhealthy for sensitive groups (101-150), unhealthy (151-200), very unhealthy (201-300), or hazardous (301+). Across criteria pollutants, the AQI value of 100 typically corresponds to the level of the short-term (
Historically, State and local agencies have primarily used the AQI to provide general information to the public about air quality and its relationship to public health. For more than two decades, many State and local agencies, as well as the EPA and other Federal agencies, have been developing new and innovative programs and initiatives to provide more information related to air quality and health messaging to the public in a more timely way. These initiatives, including air quality forecasting, near real-time data reporting through the AirNow website, use of data from air quality sensors on the EPA and U.S. Forest Service's (USFS) Fire and Smoke Map, and air quality action day programs, provide useful, up-to-date, and timely information to the public about air pollution and its health effects. Such information can help the public learn when their well-being may be compromised, so they can take actions to avoid or to reduce exposures to ambient air pollution at concentrations of concern. This information can also encourage the public to take actions that will reduce air pollution on days when concentrations are projected to be of concern to local communities (
Recognizing the scientific information available and current AQI reporting practices, the EPA proposed several revisions to the AQI PM
One purpose of the AQI is to communicate to the public when air quality is poor and thus when they should consider taking actions to reduce their exposures. The higher the AQI value, the higher the level of air pollution and the greater the health concern. In recognition of the scientific information available that is informing the reconsideration of the 2020 final decision on the primary PM
With respect to the lower AQI breakpoints in the proposal (88 FR 5638, January 27, 2023), the EPA proposed to conclude that it is appropriate to continue setting these breakpoints to be consistent with the primary annual and 24-hour PM
The historical approach to setting an AQI value of 100, which is the breakpoint between the “moderate” and “unhealthy for sensitive groups” categories, and above which advisories are generated for sensitive groups, is to set it at the same level as the primary 24-hour PM
With respect to an AQI value of 150, which is the breakpoint between the “unhealthy for sensitive groups” and “unhealthy categories,” this breakpoint concentration in this reconsideration is based upon the considering the same health effects information, as assessed in the 2019 ISA and ISA Supplement and described in section II above, that informs the proposed decisions on the level of the 24-hour standard and the AQI value of 100. Previously, the Agency has used a proportional adjustment in which the AQI value of 150 was set proportionally to the AQI value of 100. This proportional adjustment inherently recognizes that the available epidemiologic studies provide no evidence of discernible thresholds, below which effects do not occur in either sensitive groups or in the general population, that could inform conclusions regarding concentrations at which to set this breakpoint. Given that the epidemiologic evidence continues to be the most relevant health effects evidence for informing this range of AQI values, the EPA saw no basis to deviate from this approach in this reconsideration. Therefore, the EPA proposed to set an AQI value of 150 proportionally, depending on the breakpoint concentration of the AQI value of 100 (
In the proposal (88 FR 5639, January 27, 2023), the EPA summarized the history of setting the AQI values of 300 and above in the 1999 rule (64 FR 42530, August 4, 1999) and established breakpoints for PM
As part of this reconsideration, the EPA recognized that the health effects evidence associated with PM
The AQI value of 200 is the breakpoint between the “unhealthy” and “very unhealthy” categories. At AQI values above 200, the AQI would be providing a health warning that the risk of anyone experiencing a health effect following short-term exposures to these PM
In addition to epidemiologic studies evaluated in the 2019 ISA that analyzed exposures at ambient PM
When considering this collective body of evidence from controlled human exposure and epidemiologic studies, the Agency proposed to set an AQI value of 200 at a daily (
The AQI value of 300 denotes the breakpoint between the “very unhealthy” and “hazardous” categories, and thus marks the beginning of the “hazardous” AQI category. At AQI values above 300, the AQI provides a health warning that everyone is likely to experience effects following short-term exposures to these PM
In addition to the controlled human exposure studies discussed above, the epidemiologic study conducted by DeFlorio-Barker et al. (2019) examined the relationship between wildfire smoke and cardiopulmonary hospitalizations among adults 65 years of age and older from 2008-2010 in 692 U.S. counties. The authors reported a 2.22% increase in all-cause respiratory hospitalizations on wildfire smoke days for a 10 µg/m
Based on the information discussed above and in the proposal (88 FR 5640, January 27, 2023), the EPA proposed to revise the 300 level of the AQI, which marks the beginning of the “hazardous” AQI category, to a concentration that is consistent with the PM
Lastly, the EPA also proposed revisions to the 500 value of the AQI. The 500 value of the AQI is within the “hazardous” category but is specified and used to calculate the slope of the AQI values in the “hazardous category” above and below AQI values of 500. In the past, this breakpoint had a very prominent role in determining the current upper AQI values given that it was used as part of the linear relationship with the concentration at the AQI value of 100 to determine the AQI values of 200 and 300 in 1999 (64 FR 42530, August 4, 1999).
As discussed above and in the proposal (88 FR 5641, January 27, 2023), the current breakpoint concentration for the 500 value of the AQI was set in 1999 at a 24-hour average PM
In addition to the controlled human exposure studies discussed in the proposal (88 FR 5641, January 27, 2023) and summarized above, recent epidemiologic studies examining the relationship between concentrations of PM
Although studies of short-term (
The controlled human exposure studies provide biological plausibility for results of epidemiologic studies that document increases in respiratory-related health care events during the wildfires. The collective evidence from controlled human exposure and epidemiologic studies, which includes decreases in stroke volume, increased arterial stiffness, impaired vascular function and respiratory-related healthcare encounters provide health-based evidence that informed the proposed decisions on the level of the AQI value of 500. Given the concentrations observed in these studies, the Agency proposed to revise the AQI value of 500 to a level set at a daily (
Table 1 below summarizes the proposed breakpoints for the PM
The EPA received many comments on the proposed changes to the PM
Some commenters agreed with using the historical approach of setting the 50, 100 and 150 breakpoints of the AQI to be consistent with the primary PM
The few commenters that disagreed with the historical approach of the 50 breakpoint of the AQI noted that setting a short-term breakpoint to annual standard was not logical since it is a long-term standard and not meant to be interpreted for short-term messaging with the AQI, in particular when reported hourly via the NowCast. These commenters also noted that additional studies are needed to identify the health impacts of short-term exposures at low concentrations. They also noted that lowering the 50 breakpoint of the AQI in conjunction with the annual standard may cause confusion with the public because some State programs and policy decisions are connected to the AQI while others are based on PM concentrations, which could lead to inconsistent messaging reducing the public's trust. These comments were supported by noting that revised breakpoints could lead to more moderate days than in the past, but the monitor values would be the same as before when the commenters considered it “healthy,” possibly eroding trust in air agencies' messaging. Commenters also noted if the breakpoints are revised, the public will not visually be able to detect the difference between what was considered a good AQI day versus a now moderate AQI day.
The EPA disagrees with these commenters. With respect to setting a short-term breakpoint to the level of a much longer-term (annual) standard, setting the lower AQI breakpoints at the level of the annual and daily PM
With regard to the commenter stating the public may not be able to visually detect a difference in the air quality, the EPA notes that the AQI is intended to be a communication tool for public awareness precisely because it is generally difficult for the public to visually judge air quality risks when air pollution is “moderate.” Moreover, since the establishment of the AQI, the EPA and State and local air agencies and organizations have developed experience in educating the public about changes in the standards and,
Some commenters stated that the AQI should not necessarily be linked to the primary PM
With regard to the 100 breakpoint of the AQI, several commenters expressed the view that the level of the 24-hour PM
The EPA disagrees with these commenters and notes that many State, Tribal and local air agencies have expressed strong support for aligning the 100 breakpoint of the AQI with the short-term 24-hour primary PM
Some commenters supported the proposed revisions to the 200, 300 and 500 breakpoints that recognize the expanded body of scientific evidence, particularly several new epidemiologic studies conducted during high pollution events such as wildfires and multiple controlled human exposure studies. A few commenters agreed with incorporating the expanded body of scientific evidence into the 200, 300 and 500 breakpoints, but suggested a modified linear approach between 200 (115 μg/m
Other commenters disagreed with the proposed revisions and suggested the EPA should continue using the previous breakpoints that follow the 1999 linear approach (64 FR 42530, August 4, 1999), because not changing the breakpoints would simplify communications. A few commenters stated the proposed revisions to the AQI upper breakpoints are not justified because the scientific evidence supporting the revisions is inadequate. To support this view, the commenters suggest that only three epidemiologic studies were used in determining the upper breakpoints and none of them were representative of potential effects in the general public; of the 13 studies cited only three were near the proposed revised breakpoints; four of the studies involved exposure to PM from diesel and traffic pollution, which is different than PM from wildfire smoke; and the data supporting the revisions only indicated “mild” health effects that were mostly in sensitive populations.
The EPA agrees with the majority of commenters that supported utilizing the expanded body of scientific evidence to revise the 200, 300 and 500 breakpoints of the AQI. The EPA appreciates the suggestion of using a revised linear approach from 200 to 500. But rather than using the available evidence to only set the breakpoint of 500, the EPA finds it appropriate to set the breakpoints for 200, 300 and 500 using an evidence-based approach, by relying on information presented in both controlled human exposure studies and epidemiologic studies that examine relationships between high PM
The EPA disagrees with the commenters that expressed the view that these upper breakpoints should not be revised based largely on the numerous peer-reviewed studies published since the 200, 300 and 500 breakpoints were originally established in 1999 (64 FR 42530, August 4, 1999). As discussed in the proposal (88 FR 5641, January 27, 2023), the rationale behind the proposed revisions is rooted in the fact the upper AQI breakpoints are based on outdated scientific evidence. Specifically, the traditional linear approach was predicated on the 500 value of the AQI, which was estimated using health studies that used the British Smoke Method. The British Smoke Method is based on a particle size fraction (4.5 microns) that is larger
The Agency disagrees that the scientific evidence discussed in the proposal is inadequate to revise the 200, 300 and 500 breakpoints of the AQI (88 FR 5640, January 27, 2023). The EPA disagrees that these studies should not be considered because they “indicated mild health effects in sensitive populations.” The EPA notes that many of the subclinical effects discussed in the proposal (88 FR 5640, January 27, 2023) that informed the breakpoints are on the biologically plausible pathway (see 2019 ISA, section 6.1.1 and Figure 6-1) to more severe cardiovascular outcomes, such as ED visits, hospital admissions, and death as depicted in the large number of epidemiologic studies evaluated in the 2019 ISA and ISA Supplement. From a public health perspective, the purpose of the AQI is to inform the public when air quality could adversely affect their health. The scientific evidence informed revisions to the breakpoints at the upper end of the AQI allow it to better reflect the risk of experiencing health effects at higher PM
The EPA received a few additional comments on elements of the PM
A few of these commenters suggested that instead of changing the AQI averaging time, which aligns with the short-term standard, the EPA could create a public health warning system for unhealthy PM
The EPA disagrees that a shorter averaging period for the PM
In addition, there are communication benefits to aligning the averaging time of the AQI with the daily standard, as some of these commenters note, such as providing consistent messages about when it may be beneficial for people to take actions to reduce PM
At the same time, the EPA recognizes that when air quality is rapidly changing, such as during wildfire smoke events, reporting information based on a 24-hour metric may not be as useful for the public as reporting more frequently would be. The EPA has balanced concerns about being able to provide timely communication of air quality hazards when conditions are changing quickly with the goal of limiting the number of air quality communications systems and its judgment that the evidence supports a 24-hour-based metric linked to the daily standard by establishing the NowCast, which takes into consideration subdaily PM
Upon reviewing and considering the comments on the proposed revisions (summarized above in Section IV.C) along with the scientific evidence outlined in the proposal (88 FR 5639, January 27, 2023) and summarized above in section IV.A, the EPA is finalizing the proposed changes to the AQI.
Thus, as discussed in section IV of the preamble (88 FR 5639, January 27, 2023) to the proposed rule, the EPA is taking final action to revise the AQI value of 50 to 9.0 μg/m
The EPA proposed to retain the PM
With respect to the reporting requirements for the AQI and as noted in the proposal (88 FR 5642, January 27, 2023) there have been many technological advances in air quality monitoring and data reporting since the appendix G to 40 CFR part 58 was last revised in 1999. Federal, State, local, and Tribal agencies have used these changes to make health information and air quality data more readily available and easier to access. Given this, it is useful to update the reporting requirements and recommendations to match current practices and ensure the public has the most useful and timely information to take health-protective behaviors.
Currently, appendix G defines daily reporting as five days per week. When this reporting requirement was originated in 1999 the technology available at that time was not sufficient to calculate and report the AQI more than five days per week without requiring additional staffing on the weekends. Since that time, advances in technology have allowed for reporting seven days per week automatically without expending additional resources on weekends. As a result, most State, local, and Tribal air agencies now report the AQI seven days per a week. Given these technological advances and noting that reporting agencies currently report the AQI seven days per week, the EPA proposed that State, local, and Tribal agencies that report the AQI be required to report it seven days a week, ensuring that the members of the public continue to have access to daily air quality and health information that they can use to take steps to protect their health.
Improvements in monitoring networks and modeling capabilities have also enabled the ability to report the AQI in near real-time. This allows State, local, and Tribal air agencies to provide timely air quality information to the public for making health-protective decisions and to help satisfy AQI reporting requirements. The availability of near real-time AQI data also allows for more timely responses by the public when air quality conditions are changing rapidly, such as during wildfire smoke events. Subdaily reporting of the AQI can be critical when there are rapidly change conditions and/or high pollution events so that the public is able to make informed decisions to protect their health. Many State, local, and Tribal air agencies currently report the AQI hourly to ensure that the public has access to accurate and timely information. In recognition of these advances, and to continue to provide for near-real time AQI reporting that the public has come to rely on, the EPA proposed to recommend that State, local, and Tribal agencies report the AQI in near-real time.
In lieu of or along with reporting the near-real-time AQI directly to the public, most State/local and Tribal agencies submit hourly air quality data to the EPA. The EPA and some State, local and Tribal air quality agencies use this near-real-time data to create products for use by the public, weather service providers and the media as discussed in the proposal (88 FR 5643, January 27, 2023). To continue to ensure the availability of the products that the public and many stakeholders rely upon, the EPA proposed to recommend that State, local, and Tribal air quality agencies submit hourly data to the EPA's air quality database. Submitting hourly data to the EPA for use on the AirNow website and in other products also enables State, local, and Tribal air quality agencies to meet the recommendation to report the AQI in near-real-time.
In addition to the proposed updates to the reporting requirements and recommendations for near-real-time reporting and data submission recommendations, the Agency also proposed reformatting the question-and-answer format used in appendix G to align with the current standard formatting used in the Code of Federal Regulations. In proposing to update the format, the EPA did not reopen the language that has merely been moved or rearranged as there are no substantive changes.
Another change the EPA proposed to make to appendix G is with regard to Table 2—Breakpoints for the AQI for purposes of clarity. As discussed in the proposal (88 FR 5642, January 27, 2023) and summarized here, the EPA proposed to collapse the two rows presented for the Hazardous Category into one. The two rows in the current table specify pollutant concentrations for two AQI ranges within the Hazardous category (301-400 and 401-500), with an intermediate break at 400. The 400 breakpoint for all criteria pollutants in the current Table 2 is set at the proportional pollutant concentration approximately halfway between the Index values of 300 and 500. In proposing updated AQI breakpoints for PM
In addition, the EPA proposed to move some information currently in appendix G into the Technical Assistance Document for the Reporting of Daily Air Quality, or TAD (U.S. EPA, 2018a), so that it can be updated in a more timely manner to reflect current scientific and health effects evidence and current communication methods, thereby assisting State, local, and Tribal agencies in providing accurate and timely information to the public. Information that was proposed to be moved from appendix G to the TAD included the definitions of the sensitive (at-risk) populations for each pollutant.
The EPA received many comments on the proposed changes to AQI reporting, many of which supported the proposed revisions. EPA discusses several of the topics that received the most attention from commenters below. Discussion of other comments received on the proposed changes to the AQI can be found in section IV of the Responses to Significant Comments on the 2023 Proposed Reconsideration of the National Ambient Air Quality Standards for Particulate Matter.
Most commenters expressed support for revising the definition of “daily reporting” from five days a week to seven days a week. A commenter did not support this change and recommended the EPA maintain the definition of daily as five days per week, noting that State and local air agencies do not routinely work seven days per week and would not be available to perform quality control of this data and report it reliably on weekends.
The EPA appreciates the support for this proposed revision and disagrees that the proposed change would require personnel to perform quality control of AQI data on weekends. 40 CFR part 58 Appendix D defines continuous monitoring requirements for agencies participating in the State/Local Air Monitoring Stations (SLAMS) network, and Appendix G states that agencies “ . . . must use concentration data from State/Local Air Monitoring Stations (SLAMS) required by 40 CFR 58.10” when reporting the AQI. Therefore, as noted in Appendix D and G, Agencies are required to report the AQI using monitors within SLAMS, which are not subject to daily quality control/validation.
A few commenters noted that the proposal preamble language mentioned AQI is reported three ways (88 FR 5637, 5638, January 27, 2023): “The AQI is reported three ways all of which are useful and complementary. The daily AQI is reported for the previous day and used to observe trends in community air quality, the AQI forecast helps people plan their outdoor activities for the next day, and the near-real-time AQI, or NowCast AQI, tells people whether it is a good time for outdoor activity.” These commenters suggested that the NowCast is being codified in 40 CFR part 58 Appendix G as a method of calculating the AQI, which they oppose, saying that codifying its use is inappropriate given the shortest averaging period of the PM
However, some other commenters noted they appreciate the public-friendly format and near real-time data the NowCast provides and use it in their clinical encounters with patients. One air agency recognized the importance of the NowCast near real-time AQI during high pollution events and suggested the EPA should provide more “concrete” health messaging for these short-term spikes.
The EPA disagrees that the preamble language proposed to codify the NowCast or to impose a burden on reporting agencies. The preamble to the proposed rule references the AQI being reported in three ways and it does so because the EPA and many State, local and Tribal air quality agencies already report it these three ways. However, text included in the preamble is generally explanatory and does not alter regulatory provisions. Comments that State that EPA is codifying the NowCast into Appendix G are incorrect. Further, in proposed revisions to 40 CFR part 58 Appendix G, the EPA recommended, but did not propose to require, the use of air quality forecasts and a subdaily AQI. Consistent with the proposal, the EPA is therefore not finalizing any additional requirement or burden on States' forecasting staff relative to forecasts or a subdaily AQI.
The EPA disagrees with the comment that the NowCast values have no direct correlation to the AQI calculation methodology codified in 40 CFR part 58 Appendix G. As noted in the AQI Technical Assistance Document (Technical Assistance Document for the Reporting of Daily Air Quality—the Air Quality Index (AQI)), the NowCast algorithm is based on the AQI methodology but provides more real-time information to the public (U.S. EPA, 2018a). While the NowCast algorithm is approximating a 24-hour average exposure, it can reflect concentrations observed over shorter averaging times when air quality is changing rapidly (U.S. EPA, 2018a). The EPA reflects the nature of the NowCast in the health messaging provided there.
As noted in the above discussion of the AQI, air quality can change quickly during the day. A central purpose of the AQI is to help the public know when it is prudent to take action to reduce their exposure to pollution. Accordingly, the EPA developed the NowCast to estimate the 24-hour AQI for the current hour to give people information and tools to reduce their exposures to protect their health, particularly when air quality may be changing. The NowCast gives people the knowledge and ability to take timely action. They can use this information to reduce their exposure—reducing exposures if PM
The first NowCast method was developed in 2003 and was designed so “current conditions” represent the 24-hour PM
After evaluating the 2013 NowCast method, the EPA concluded that it matched the desired characteristics. The NowCast method responds to rapid changes in air quality yet still reflects a
The AQI is designed to allow people to reduce their exposure when pollution levels are higher and be active outdoors when pollution levels are lower. Since air quality almost always changes during the day, that level of granularity is not possible with a 24-hour forecast. If the public has only the 24-hour forecast, they may miss the times to be active outdoors when air quality is better and may be active outdoors when air quality is worse.
Also as noted above, many entities appreciate the near real-time reporting of the AQI that the NowCast provides and suggested more specific messaging is needed. The EPA appreciates this insight and will continue to consider ways to communicate air quality information most effectively to the public. For example, in light of recent wildfire events, the EPA worked with the USFS to pilot the AirNow Fire and Smoke Map.
Upon reviewing and considering the comments on the proposed revisions (summarized above in Section IV.C) along with the rationale outlined in the proposal (88 FR 5638, January 27, 2023) and summarized above in section IV.C, the EPA is finalizing the proposed changes to the AQI reporting requirements. Thus, as discussed in section IV of the preamble to the proposed rule, the EPA is taking final action to require the AQI be reported seven days a week; recommend that State, local, and Tribal agencies report the AQI in near-real time; recommend that State, local, and Tribal air quality agencies submit hourly data to the EPA's air quality database; reformat appendix G to align with the current standard formatting used in the Code of Federal Regulations; collapse the two rows in Table 2 presented for the Hazardous Category into one by removing the 400 breakpoint; and move some information currently in appendix G into the Technical Assistance Document for the Reporting of Daily Air Quality, or TAD (U.S. EPA, 2018a) such as including the definitions of the sensitive (at-risk) populations for each pollutant and suggested approaches for public communication as stated in the revised Appendix G.
Table 2 below summarizes the breakpoints for the PM
This section presents the rationale for the Administrator's decision that no change to the current secondary PM standards is required at this time to provide requisite protection against the public welfare effects of PM within the scope of this reconsideration (
In presenting the rationale for the Administrator's final decision and its foundations, section V.A provides background on the 2020 final decision to retain the secondary PM standards (section V.A.1), and also provides brief summaries of key aspects of the currently available welfare effects evidence (section V.A.2) and quantitative information (section V.A.3). Section V.B summarizes the CASAC's advice (section V.B.1) and the proposed conclusions (section V.B.2), addresses public comments received on the proposal (section V.B.3), and presents the Administrator's conclusions on the adequacy of the current standards (section V.B.4), drawing on consideration of the available scientific and quantitative information, advice from the CASAC, and comments from the public. Section V.C summarizes the Administrator's decision on the secondary PM standards.
The general approach for this reconsideration of the 2020 final decision on the secondary PM standards relies on the EPA's assessments of the current scientific evidence and associated quantitative analyses to inform the Administrator's judgments regarding secondary standards that are requisite to protect the public welfare from known or anticipated adverse effects associated with the pollutant's presence in the ambient air. The EPA's assessments are primarily documented in the 2019 ISA, ISA Supplement, and 2022 PA, which builds on the 2020 PA, all of which have received CASAC review and public comment (83 FR 53471, October 23, 2018; 83 FR 55529, November 6, 2018; 85 FR 4655, January 27, 2020; 86 FR 52673, September 22, 2021; 86 FR 54186, September 30, 2021; 86 FR 56263, October 8, 2021; 87 FR 958, January 7, 2022; 87 FR 22207, April 14, 2022; 87 FR 31965, May 26, 2022). In bridging the gap between the scientific assessments of the 2019 ISA and ISA Supplement and the judgments required of the Administrator in determining whether the current standards provide the requisite public welfare protection, the 2022 PA evaluates policy implications of the evaluation of the current evidence in the 2019 ISA and ISA Supplement, and the quantitative information documented in the 2022 PA. In evaluating the public welfare protection afforded by the current standards against PM-related effects within the scope of this reconsideration, the four basic elements of the NAAQS (indicator, averaging time, level, and form) are considered collectively.
The final decision on the adequacy of the current secondary standards is a public welfare policy judgment to be made by the Administrator. In reaching conclusions with regard to the standard, the decision draws on the scientific information and analyses about welfare effects, and associated public welfare significance, as well as judgments about how to consider the range and magnitude of uncertainties that are inherent in the scientific evidence and analyses. This approach is based on the recognition that the available evidence generally reflects a continuum that includes ambient air exposures at which scientists agree that effects are likely to occur through lower levels at which the likelihood and magnitude of responses become increasingly uncertain. This approach is consistent with the requirements of the provisions of the Clean Air Act related to the review of NAAQS and with how the EPA and the courts have historically interpreted the Act. These provisions require the Administrator to establish secondary standards that, in the judgment of the Administrator, are requisite to protect public welfare from known or anticipated adverse effects associated with the presence of the pollutant in the ambient air. In so doing, the Administrator seeks to establish standards that are neither more nor less stringent than necessary for this purpose. The Act does not require that standards be set at a zero-risk level, but rather at a level that reduces risk sufficiently so as to protect the public welfare from known or anticipated adverse effects.
The current secondary PM standards were retained in 2020 based on the scientific and technical information available at that time, as well as the then-Administrator's judgments regarding the available welfare effects evidence, the appropriate degree of public welfare protection for the existing standards, and available air quality information on visibility impairment that may be allowed by such a standard (85 FR 82684, December 18, 2020). With the 2020 decision, the then-Administrator retained the secondary 24-hour PM
In light of the robust evidence base, the 2019 ISA concluded there to be causal relationships between PM and climate effects and materials effects (U.S. EPA, 2019a, sections 13.3.9 and 13.4.2). The 2020 final decision was based on a thorough review in the 2019 ISA of the scientific information on PM-induced climate and materials effects. The decision also took into account: (1) Assessments in the 2020 PA of the most policy-relevant information in the 2019 ISA regarding evidence of adverse effects of PM to climate and materials, (2) uncertainties in the available evidence to inform a quantitative assessment of PM-related climate and materials effects, (3) CASAC advice and recommendations, and (4) public comments received during the development of these documents and on the proposal document.
In considering non-visibility welfare effects in the 2020 decision, the then-Administrator concluded that, while it is important to maintain an appropriate degree of control of fine and coarse particles to address non-visibility welfare effects, “it is generally appropriate to retain the existing standards and that there is insufficient information to establish any distinct secondary PM standards to address climate and materials effects of PM” (85 FR 82744, December 18, 2020).
With regard to climate, the then-Administrator recognized that there were a number of improvements and refinements to climate models since the 2012 review. However, while the evidence continued to support a causal relationship between PM and climate effects, the then-Administrator noted that significant limitations continued to exist related to quantifying the contributions of direct and indirect
With regard to materials effects, the then-Administrator noted that the evidence available in the 2019 ISA continued to support a causal relationship between materials effects and PM deposition (U.S. EPA, 2019a, section 13.4). He recognized that the deposition of fine and coarse particles to materials can lead to physical damage and/or impaired aesthetic qualities. Particles can contribute to materials damage by adding to the natural weathering processes and by promoting the corrosion of metals, the degradation of building materials, and the weakening of material components. While some new information was available in the 2019 ISA, the information was from studies primarily conducted outside of the U.S. in areas where PM concentrations in ambient air are higher than those observed in the U.S. (U.S. EPA, 2020b, section 13.4). Additionally, the information assessed in the 2019 ISA did not support quantitative analyses of PM-related materials effects in the 2020 PA (U.S. EPA, 2020b, section 5.2.2.2.2). Given the limited amount of information available and its inherent uncertainties and limitations, the Administrator concluded that he was unable to relate soiling or damage to specific levels of PM in ambient air or to evaluate or consider a level of air quality to protect against such materials effects, and that there was insufficient information available to support a distinct national ambient standard based on materials effects (85 FR 82744, December 18, 2020).
In reviewing the 2019 draft PA, the CASAC agreed with staff conclusions that, while these effects are important, “the available evidence does not call into question the protection afforded by the current secondary PM standards” and recommended that the secondary standards “should be retained” (Cox, 2019b, p. 3 of letter). In reaching a final decision in 2020, for all of the reasons discussed above and recognizing the CASAC conclusion that the evidence provided support for retaining the current secondary PM standards, the then-Administrator concluded that it was appropriate to retain the existing secondary PM standards, without revision. For climate and materials effects, this conclusion reflected his judgment that, although it remains important to maintain secondary PM
The 2019 ISA concluded that, “the evidence is sufficient to conclude that a causal relationship exists between PM and visibility impairment” (U.S. EPA, 2019a, section 13.2.6). The 2020 decision on the adequacy of the secondary standards with regard to visibility effects was a public welfare policy judgment made by the then-Administrator, which drew upon the available scientific evidence for PM-related visibility effects and on analyses of visibility impairment, as well as judgments about the appropriate weight to place on the range of uncertainties inherent in the evidence and analyses. The 2020 final decision was based on a thorough review in the 2019 ISA of the scientific information on PM-related visibility effects. The decision also took into account: (1) Assessments in the 2020 PA of the most policy-relevant information in the 2019 ISA regarding evidence of adverse effects of PM on visibility; (2) air quality analyses of the PM
In considering the visibility effects in the 2020 review, the then-Administrator noted the long-standing body of evidence for PM-related visibility impairment. This evidence, which is based on the fundamental relationship between light extinction and PM mass, demonstrated that ambient PM can impair visibility in both urban and remote areas, and had changed very little since the 2012 review (U.S. EPA, 2019a, section 13.1; U.S. EPA, 2009a, section 9.2.5). The evidence related to public perception of visibility impairment was from studies from four areas in North America.
Consistent with the 2012 review, in the 2020 review, the then-Administrator first concluded that a target level of protection for a secondary PM standard is most appropriately defined in terms of a visibility index that directly takes into account the factors (
First, with regard to indicator, the then-Administrator noted that in the 2012 review, the EPA used an index based on estimates of light extinction by PM
In further defining the characteristics of a visibility index, the then-Administrator next considered the appropriate averaging time, form, and level of the index. Given the available scientific information the review, and in considering the CASAC's advice and public comments, the then-Administrator concluded that, consistent with the decision in the 2012 review, a visibility index with a 24-hour averaging time and a form based on the 3-year average of annual 90th percentile values remained reasonable. With regard to the averaging time and form of such an index, the Administrator noted analyses conducted in the last review that demonstrated relatively strong correlations between 24-hour and subdaily (
With regard to the level of a visibility index, consistent with the 2012 review, the then-Administrator judged that it was appropriate to establish a target level of protection of 30 deciviews (dv),
Given that there were no new preference studies in the 2019 ISA, the then-Administrator's judgments in 2020 were based on the same studies, with the same range of levels, available in the 2012 review. The 2020 PA (U.S. EPA, 2020b, section 5.5), discussed a number of limitations and uncertainties associated with these studies. In considering the scientific information, with its uncertainties and limitations, as well as public comments on the level of the target level of protection against visibility impairment, the then-Administrator concluded that it was appropriate to again use a level of 30 dv for the visibility index (78 FR 82742-82744, December 18, 2020).
Having concluded that the protection provided by a standard defined in terms of a PM
In this context, the then-Administrator considered the updated analyses of visibility impairment presented in the 2020 PA (U.S. EPA, 2020b, section 5.2.1.2), which reflected a number of improvements since the 2012 review. Specifically, the updated analyses examined multiple versions of the IMPROVE equation, including the version incorporating revisions since the time of the 2012 review. These updated analyses provided a further understanding of how variation in the inputs to the algorithms affect the estimates of light extinction (U.S. EPA, 2020b, Appendix D). Additionally, for a subset of monitoring sites with available PM
The results of the updated analyses in the 2020 PA were consistent with those from the 2012 review. Regardless of which version of the IMPROVE equation was used, the analyses demonstrated that, based on 2015-2017 data, the 3-year visibility metric was at or below about 30 dv in all areas meeting the current 24-hour PM
The information summarized here is based on the scientific assessment of the welfare effects evidence available in this reconsideration; this assessment is documented in the 2019 ISA and ISA Supplement and its policy implications are further discussed in the 2022 PA. While the 2019 ISA provides the broad scientific foundation for this reconsideration, additional literature has become available since the cutoff date of the 2019 ISA that expands the body of evidence related to visibility effects that can inform the Administrator's judgment on the adequacy of the current secondary PM standards. As such, the ISA Supplement builds on the information in the 2019 ISA with a targeted identification and evaluation of new scientific information regarding visibility effects. As described in the ISA Supplement and the 2022 PA, the selection of welfare effects to evaluate within the ISA Supplement were based on the causality determinations reported in the 2019 ISA and the subsequent use of scientific evidence in the 2020 PA (U.S. EPA, 2019a, section 1.2; U.S. EPA, 2022a, section 1.4.2). The ISA Supplement focuses on U.S. and Canadian studies that provide new information on public preferences for visibility impairment and/or developed new methodologies or conducted quantitative analyses of light extinction (U.S. EPA, 2022a, section 1.2). Such studies of visibility effects and quantitative relationships between visibility impairment and PM in ambient air were considered to be of greatest utility in informing the Administrator's conclusions on the adequacy of the current secondary PM standards. The visibility effects evidence presented within the 2019 ISA, along with the targeted identification and evaluation of new scientific information in the ISA Supplement, provides the scientific basis for the reconsideration of the 2020 final decision on the secondary PM standards for visibility effects. For climate and materials effects, the 2020 PA concluded that there were substantial uncertainties associated with the quantitative relationships with PM concentrations and the concentration patterns that limited the ability to quantitatively assess the public welfare protection provided by the standards from these effects. Therefore, the evaluation of the information related to these effects draws heavily from the 2019 ISA and 2020 PA. The subsections below briefly summarize the nature of PM-related visibility (section V.B.1.a), climate (section V.B.1.b), and materials (section V.B.1.c) effects.
Visibility impairment can have implications for people's enjoyment of daily activities and for their overall sense of well-being (U.S. EPA, 2009a, section 9.2). The strongest evidence for PM-related visibility impairment comes from the fundamental relationship between light extinction and PM mass (U.S. EPA, 2009a), which confirms a well-established “causal relationship exists between PM and visibility impairment” (U.S. EPA, 2009a, p. 2-28). Beyond its effects on visibility, the 2009 ISA also identified a causal relationship “between PM and climate effects, including both direct effects of radiative forcing and indirect effects that involve cloud and feedbacks that influence precipitation formation and cloud lifetimes” (U.S. EPA, 2009a, p. 2-29). The evidence also supports a causal relationship between PM and effects on materials, including soiling effects and materials damage (U.S. EPA, 2009a, p. 2-31).
The evidence available in this reconsideration is consistent with the evidence available at the time of the 2012 and 2020 reviews and supports the conclusions of causal relationships between PM and visibility, climate, and materials effects (U.S. EPA, 2019a, chapter 13). Evidence newly available in this reconsideration augments the previously available evidence of the relationship between PM and visibility impairment (U.S. EPA, 2019a, section 13.2; U.S. EPA, 2022a, section 4), climate effects (U.S. EPA, 2019a, section 13.3), and materials effects (U.S. EPA, 2019a, section 13.4).
The fundamental relationship between light extinction and PM mass, and the EPA's understanding of this relationship, has changed little since the 2009 ISA (U.S. EPA, 2009a). The combined effect of light scattering and absorption by particles and gases is characterized as light extinction,
As at the time of the 2012 and 2020 reviews, direct measurements of PM light extinction, scattering, and absorption continue to be considered more accurate for quantifying visibility than PM mass-based estimates because measurements do not depend on assumptions about particle characteristics (
In the absence of a robust monitoring network for the routine measurement of light extinction across the U.S., estimation of light extinction based on existing PM monitoring can be used. The theoretical relationship between light extinction and PM characteristics, as derived from Mie theory (U.S. EPA, 2019a, Equation 13.5), can be used to estimate light extinction by combining mass scattering efficiencies of particles with particle concentrations (U.S. EPA, 2019a, section 13.2.3; U.S. EPA, 2009a, sections 9.2.2.2 and 9.2.3.1). This estimation of light extinction is consistent with the method used in previous reviews. The algorithm used to estimate light extinction, known as the IMPROVE algorithm,
At the time of the 2012 review, two versions of the IMPROVE algorithm were available in the literature—the original IMPROVE algorithm (Lowenthal and Kumar, 2004, Malm and Hand, 2007, Ryan et al., 2005) and the revised IMPROVE algorithm (Pitchford et al., 2007). As described in detail in the 2022 PA (U.S. EPA, 2022b, section 5.3.1.1) and the 2019 ISA (U.S. EPA, 2019a, section 13.2.3), the algorithm has been further evaluated and refined since the time of the 2012 review (Lowenthal and Kumar, 2016), particularly for PM characteristics and relative humidity in remote areas. All three versions of the IMPROVE algorithm were considered in evaluating visibility impairment in this reconsideration.
Consistent with the evidence available at the time of the 2012 and 2020 reviews, our understanding of public perception of visibility impairment comes from visibility preference studies conducted in four areas in North America.
Since the completion of the 2009 and 2019 ISAs, there has been only one public preference study that has become available in the U.S. This study uses images of the Grand Canyon, AZ, described in the ISA Supplement (U.S. EPA, 2022a). The Grand Canyon study, conducted by Malm et al. (2019), has a similar study design to that used in the public preference studies discussed above; however, there are several important differences that make it difficult to directly compare the results of the Malm et al. (2019) study with other public preference studies. As an initial matter, the Grand Canyon study was conducted in a Federal Class I area, as opposed to in an urban area, with a scene depicted in the photographs that did not include urban features.
The Malm et al. (2019) study also explored alternate methods for evaluating “acceptable” levels of visual air quality from the preference studies, including the use of scene-specific visibility indices as potential indicators of visibility levels as perceived by the observer (Malm et al., 2019). In addition to measures of atmospheric haze, such
The available evidence continues to support the conclusion of a causal relationship between PM and climate effects (U.S. EPA, 2019a, section 13.3.9). Since the 2012 review, climate impacts have been extensively studied and recent research reinforces and strengthens the evidence evaluated in the 2009 ISA. Recent evidence provides greater specificity about the details of radiative forcing effects
As described in the proposal (88 FR 5650, January 27, 2023), PM has a very heterogeneous distribution globally and patterns of forcing tend to correlate with PM loading, with the greatest forcings centralized over continental regions. The climate response to this PM forcing, however, is more complicated since the perturbation to one climate variable (
Consistent with the evidence assessed in the 2009 ISA, the available evidence continues to support the conclusion that there is a causal relationship between PM deposition and materials effects. Effects of deposited PM, particularly sulfates and nitrates, to materials include both physical damage and impaired aesthetic qualities, generally involving soiling and/or corrosion (U.S. EPA, 2019a, section 13.4.2). Because of their electrolytic, hygroscopic, and acidic properties and their ability to sorb corrosive gases, particles contribute to materials damage by adding to the effects of natural weathering processes, by potentially promoting or accelerating the corrosion of metals, degradation of painted surfaces, deterioration of building materials, and weakening of material components.
Building on the evidence available in the 2009 ISA, and as described in detail in the proposal (88 FR 5650, January 27, 2023) and in the 2019 ISA (U.S. EPA, 2019a, section 13.4), research has progressed on (1) the theoretical understanding of soiling of items of cultural heritage; (2) the quantification of degradation rates and further characterization of factors that influence damage of stone materials; (3) materials damage from PM components besides sulfate and black carbon and atmospheric gases besides SO
Beyond the consideration of the scientific evidence, as discussed in section V.A.2 above, quantitative analyses of PM air quality, when available, can also inform conclusions on the adequacy of the public welfare protection provided by the current secondary PM standards.
In the 2012 and 2020 reviews, quantitative analyses for PM-related visibility effects focused on daily visibility impairment, given the short-term nature of PM-related visibility effects. The evidence and information available in this reconsideration continues to provide support for the short-term (
i. Target Level of Protection in Terms of a PM
In evaluating the adequacy of the current secondary PM standards, the 2022 PA first evaluates the appropriateness of the elements (indicator, averaging time, form, and level) identified for a visibility index to protect against visibility effects. In previous reviews, the visibility index as set at a level of 30 dv, with estimated light extinction as the indicator, a 24-hour averaging time, and a 90th percentile form, averaged over three years.
With regard to an indicator for the visibility index, the 2022 PA recognizes the lack of availability of methods and an established network for directly measuring light extinction (U.S. EPA, 2022b, section 5.3.1.1). Therefore, consistent with previous reviews, the 2022 PA concludes that a visibility index based on estimates of light extinction by PM
With regard to averaging time, the 2022 PA notes that the evidence continues to provide support for the short-term nature of PM-related visibility effects. Given that there is no new information available regarding the time periods during which visibility impairment occurs or public preferences related to specific time periods for visibility impairment, the 2022 PA concludes that it is appropriate to continue to focus on daily visibility impairment. In so doing, the 2022 PA relies on analyses that were conducted in the 2012 review that showed relatively strong correlations between 24-hour and subdaily (
With regard to the form for the visibility index, the available information continues to provide support for a 3-year average of annual 90th percentile values. Given that there is no new information to inform selection of an alternate form, as in previous reviews, the 2022 PA notes that the 3-year average form provides stability from the occasional effect of inter-annual meteorological variability that can result in unusually high pollution levels for a particular year (85 FR 82741, December 18, 2020; 78 FR 3198, January 15, 2013; U.S. EPA, 2011, p. 4-58). In so doing, the 2022 PA considers the evaluation in the 2010 Urban-Focused Visibility Assessment (UFVA) of three different statistical forms: 90th, 95th, and 98th percentiles (U.S. EPA, 2010b, Chapter 4).). In considering this evaluation of statistical forms from the 2010 UFVA, consistent with the 2011 PA, the 2022 PA notes that the Regional Haze Program targets the 20 percent most impaired days for visibility improvements in visual air quality in Federal Class I areas and that the median of the distribution of these 20 percent most impaired days would be the 90th percentile. The 2011 PA also noted that strategies that are implemented so that 90 percent of days would have visual air quality that is at or below the level of the visibility index would reasonably be expected to lead to improvements in visual air quality for the 20 percent most impaired days. Additionally, as in the 2011 PA, the 2022 PA recognizes that the available public preference studies do not address frequency of occurrence of different levels of visibility (U.S. EPA, 2022b, section 5.3.1.2). Therefore, the analyses and consideration for the form of a visibility index from the 2011 PA continue to provide support for a 90th percentile form, averaged across three years, in defining the characteristics of a visibility index in this reconsideration.
With regard to the level for the visibility index, the 2022 PA recognizes that there is an additional public preference study (Malm et al., 2019) available in this reconsideration. As noted above, however, this study differs from the previously available public preference studies in several ways, which makes it difficult to integrate this newly available study with the previously available studies. Most significantly, this study was evaluated public preferences for visibility in the Grand Canyon, perhaps the most notable Class I area in the country for visibility purposes. Therefore, the 2022 PA concludes that the Grand Canyon study is not directly comparable to the other available preferences studies and public preferences of visibility impairment in the Malm et al. (2019) study are not appropriate to consider in identifying a range of levels for the target level of protection against visibility impairment for this reconsideration of the secondary PM NAAQS.
Therefore, the 2022 PA continues to rely on the same studies
In considering the available public preference studies, consistent with past reviews, the 2022 PA concludes that it is reasonable to consider a range of 20 to 30 dv for selecting a target level of protection, including a high value of 30 dv, a midpoint value of 25 dv, and a low value of 20 dv. A target level of protection at or in the upper end of the range would focus on the Washington, DC, preference study results (Abt Associates, 2001; Smith and Howell, 2009), which identified 30 dv as the level of impairment that was determined to be “acceptable” by at least 50 percent of study participants. The public preferences of visibility impairment in the Washington, DC, study are likely to be generally representative of urban areas that do not have valued scenic elements (
A target level of protection in the middle of the range would be most closely associated with the level of impairment that was determined to be “acceptable” by at least 50 percent of study participants in the Phoenix, AZ, study (BBC Research & Consulting, 2003), which was 24 dv. This study, while methodologically similar to the other public preference studies, included participants that were selected as a representative sample of the Phoenix area population
A target level of protection at or just above the lower end of the range would focus on the Denver, CO, study, but may not be as strongly supported as higher levels within the range (Ely et al., 1991). Older studies, such as those conducted in Denver, CO (Ely et al., 1991), and British Columbia, Canada (Pryor, 1996), used photographs that were taken at different times of the day and on different days to capture a range of light extinction levels needed for the preference studies. Compared to studies that used computer-generated images (
In addition to differences in preferences that may arise from photographs versus computer-generated images, urban visibility preference may differ by location, and such differences may arise from differences in the cityscape scene that is depicted in the images. These differences are related to the perceived value of objects and scenes that are included in the image, as objects at a greater distance have a greater sensitivity to perceived visibility changes as light extinction is changed compared to similar scenes with objects at shorter distances. For example, a person (regardless of their location) evaluating visibility in an image with more scenic elements such as mountains or natural views may value better visibility conditions in these images compared to the same level of visibility impairment in an image that only depicts urban features such as buildings and roads. That is, if a person was shown the same level of visibility impairment in two images depicting different scenes—one with mountains in the background and urban features in the foreground and one with no mountains in the background and nearby buildings in the image without mountains in the distance—may find the amount of haze to be unacceptable in the image with the mountains in the distance because of a greater perceived value of viewing the mountains, while finding the amount of haze to be acceptable in the image with the buildings because of a lesser value of viewing the cityscape or an expectation that such urban areas may generally have higher levels of haze in general. This is consistent when comparing the differences between the Denver, CO, study results (which found the 50% acceptance criteria occurred at the best visual air quality levels among the four cities) and the Washington, DC, results (which found the 50% acceptability criteria occurred at the worst visual air quality levels among the four cities). These results may occur because the most prominent and picturesque feature of the cityscape of Denver is the visible snow-covered mountains in the distance, while the prominent and
Taken together, the 2022 PA concludes that available information continues to support a visibility index with estimated light extinction as the indicator, a 24-hour averaging time, and a 90th percentile form, averaged over three years, with a level within the range of 20 to 30 dv.
The 2022 PA presents quantitative analyses based on recent air quality that evaluate the relationship between recent air quality and calculated light extinction. As in previous reviews, these analyses explored this relationship as an estimate of visibility impairment in terms of the 24-hour PM
When light extinction was calculated using the revised IMPROVE equation, in areas that meet the current 24-hour PM
When light extinction was calculated using the revised IMPROVE equation,
When light extinction was calculated using the refined equation from Lowenthal and Kumar (2016), the resulting 3-year visibility metrics are slightly higher at all sites compared to light extinction estimates calculated using the original IMPROVE equation (U.S. EPA, 2022b, Figure 5-5).
Nevertheless, when light extinction is calculated using the Lowenthal and
In considering visibility impairment under recent air quality conditions, the 2022 PA recognizes that the differences in the inputs to equations estimating light extinction can influence the resulting values. For example, given the varying chemical composition of emissions from different sources, the 2.1 multiplier for converting OC to organic matter (OM) in the Lowenthal and Kumar (2016) equation may not be appropriate for all source types. At the time of the 2012 review, the EPA judged that a 1.6 multiplier was more appropriate, for the purposes of estimating visibility index at sites across the U.S., than the 1.4 or 1.8 multipliers used in the original and revised IMPROVE equations, respectively. A multiplier of 1.8 or 2.1 would account for the more aged and oxygenated organic PM that tends to be found in more remote regions than in urban regions, whereas a multiplier of 1.4 may underestimate the contribution of organic PM found in remote regions when estimating light extinction (78 FR 3206, January 15, 2013; U.S. EPA, 2012, p. IV-5). The available scientific information and results of the air quality analyses indicate that it may be appropriate to select inputs to the IMPROVE equation (
At the time of the 2012 review, the EPA noted that PM
Overall, the findings of these updated quantitative analyses are generally consistent with those in the 2012 and 2020 reviews. The 3-year visibility metric was generally below 26 dv in most areas that meet the current 24-hour PM
Consistent with the evidence available at the time of the 2012 and 2020 reviews, and as described in detail in the 2022 PA (U.S. EPA, 2022b, section 5.3.2.2), the data remain insufficient to conduct quantitative analyses for PM effects on climate and materials. For PM-related climate effects, as explained in more detail in the proposal (88 FR 5654, January 27, 2023), our understanding of PM-related climate effects is still limited by significant key uncertainties. The recently available evidence does not appreciably improve our understanding of the spatial and temporal heterogeneity of PM components that contribute to climate forcing (U.S. EPA, 2022b, sections 5.3.2.1.1 and 5.5). Significant uncertainties also persist related to quantifying the contributions of PM and PM components to the direct and indirect effects on climate forcing, such as changes to the pattern of rainfall, changes to wind patterns, and effects on vertical mixing in the atmosphere (U.S. EPA, 2022b, sections 5.3.2.1.1 and 5.5). Additionally, while improvements have been made to climate models since the completion of the 2009 ISA, the models continue to exhibit variability in estimates of the PM-related climate effects on regional scales (
For PM-related materials effects, as explained in more detail in the 2022 PA (U.S. EPA, 2022b, section 5.3.2.2), the available evidence has been somewhat expanded to include additional information about the soiling process and the types of materials impacted by PM. This evidence provides some limited information to inform dose-response relationships and damage functions associated with PM, although most of these studies were conducted outside of the U.S. where PM concentrations in ambient air are typically above those observed in the U.S. (U.S. EPA, 2022b, section 5.3.2.1.2; U.S. EPA, 2019a, section 13.4). The evidence on materials effects characterized in the 2019 ISA also includes studies examining effects of PM on the energy efficiency of solar panels and passive cooling building materials, although the evidence remains insufficient to establish quantitative relationships between PM in ambient air and these or other materials effects (U.S. EPA, 2022b, section 5.3.2.1.2). While the available evidence assessed in the 2019 ISA is somewhat expanded since the time of the 2012 review, quantitative relationships have not been established for PM-related soiling and corrosion and frequency of cleaning or repair that further the understanding of the public welfare implications of materials effects (U.S. EPA, 2022b, section 5.3.2.2.2; U.S. EPA, 2019a, section 13.4). Therefore, there is insufficient information to inform quantitative analyses assessing materials effects to inform consideration of a national PM standard on materials in this reconsideration (U.S. EPA, 2022b, section 5.3.2.2.2; U.S. EPA, 2019a, section 13.4).
In drawing conclusions on the adequacy of the current secondary PM standards, in view of the advances in scientific knowledge and additional information now available, the Administrator has considered the evidence base, information, and policy judgments that were the foundation of the 2020 decision and reflects upon the body of information and evidence available in this reconsideration. In so doing, the Administrator has taken into account both evidence-based and quantitative information-based considerations, as well as advice from the CASAC and public comments. Evidence-based considerations draw upon the EPA's assessment and integrated synthesis of the scientific evidence from studies evaluating welfare effects related to visibility, climate, and materials associated with PM in ambient air as discussed in the 2022 PA (summarized in sections V.B and V.D.2 of the proposal, section V.A.2 above). The quantitative information-based considerations draw from the results of the quantitative analyses of visibility impairment presented in the 2022 PA (as summarized in section V.C of the proposal and V.A.3 above) and consideration of these results in the 2022 PA.
Consideration of the scientific evidence and quantitative information in the 2022 PA and by the Administrator is framed by consideration of a series of policy-relevant questions. Section V.B.2 below summarizes the rationale for the Administrators proposed decision, drawing from section V.D.3 of the proposal. The advice and recommendations of the CASAC and public comments on the proposed decision are addressed below in sections V.B.1 and V.B.3, respectively. The Administrator's conclusions in this reconsideration regarding the adequacy of the secondary PM standards and whether any revisions are appropriate are described in section V.D.4.
In comments on the 2019 draft PA, the CASAC concurred with the staff's overall preliminary conclusions that it is appropriate to consider retaining the current secondary standards without revision (Cox, 2019b). The CASAC “finds much of the information . . . on visibility and materials effects of PM
In this reconsideration, the CASAC provided its advice regarding the current secondary PM standards in the context of its review of the 2021 draft PA (Sheppard, 2022a). In its comments on the 2021 draft PA, the CASAC first recognized that the scientific evidence is sufficient to support a causal relationship between PM and visibility effects, climate effects and materials effects.
With regard to visibility effects, the CASAC recognized that the identification of a target level of protection for the visibility index is based on a limited number of studies and suggested that “additional region- and view-specific visibility preference studies and data analyses are needed to support a more refined visibility target” (Sheppard, 2022a, p. 21 of consensus responses). While the CASAC did not recommend revising either the target level of protection for the visibility index or the level of the current 24-hour PM
The CASAC also recognized the limited availability of monitoring methods and networks for directly measuring light extinction. As such, they suggest that “[a] more extensive technical evaluation of the alternatives for visibility indicators and practical measurement methods (including the necessity for a visibility FRM) is need for future reviews” (Sheppard, 2022a, p. 22 of consensus letter). The majority of the CASAC “recommend[ed] that an FRM for a directly measured PM
With regard to climate, the CASAC noted that “there is a causal relationship between PM and climate change, but large uncertainties remain” and recommended additional research (Sheppard, 2022a, p. 22 of consensus responses). With respect to materials damage, the CASAC noted that “[q]uantitative information on the relationship between PM and material damage is lacking” and suggested some additional studies and research approaches that could provide additional information on the effects of PM on materials and the quantitative assessment of the relationship between materials effects and PM in ambient air (Sheppard, 2022a, p. 23 of consensus responses).
In reaching his proposed conclusions, the Administrator first recognized that, consistent with the scope of this reconsideration, his decision in this reconsideration will be focused only and specifically on the adequacy of public welfare protection provided by the secondary PM standards from effects related to visibility, climate, and materials. He then considered the assessment of the current evidence and conclusions reached in the 2019 ISA and ISA Supplement; the currently available quantitative information, including associated limitations and uncertainties, described in detail and characterized in the 2022 PA; considerations and staff conclusions and associated rationales presented in the 2022 PA; and the advice and recommendations from the CASAC (88 FR 5655, January 27, 2023).
With respect to visibility, the Administrator noted the longstanding body of evidence that demonstrates a causal relationship between ambient PM and effects on visibility (U.S. EPA, 2019a, section 13.2). and that visibility impairment can have implications for people's enjoyment of daily activities and for their overall sense of well-being. Therefore, as in previous reviews, he considered the degree to which the current secondary standards protect against PM-related visibility impairment. In so doing, and consistent with previous reviews, the Administrator considered the protection provided by the current secondary standards against PM-related visibility impairment in conjunction with the Regional Haze Program
In further considering what standards are requisite to protect against adverse public welfare effects from visibility impairment, the Administrator adopted an approach consistent with the approach used in previous reviews (88 FR 5645, January 27, 2023). That is, he first identified an appropriate target level of protection in terms of a PM visibility index that accounts for the factors that influence the relationship between particles in the ambient air and visibility (
To identify a target level of protection, the Administrator first considered the characteristics of the visibility index and defines its elements (indicator, averaging time, form, and level). With regard to the indicator for the visibility index, the Administrator recognized that there is a lack of availability of methods and an established network for directly measuring light extinction, consistent with the conclusions reached in the 2022 PA (U.S. EPA, 2022b, section 5.3.1.1) and with the CASAC's recommendation for additional research on direct measurement methods for light extinction in their review of the 2021 draft PA (Sheppard, 2022a, p. 22 of consensus responses). Consistent with the approaches used in reaching decisions in 2012 and 2020, given the lack of such monitoring data, the Administrator preliminarily judged that estimated light extinction, as calculated using one or more versions of the IMPROVE algorithms, continues to be the most appropriate indicator for the visibility index in this reconsideration (88 FR 5659, January 27, 2023).
In further defining the characteristics of a visibility index based on estimates of light extinction, the Administrator considered the appropriate averaging time, form, and level of the index. With regard to the averaging time and form, the Administrator noted that in previous reviews, a 24-hour averaging time was selected and the form was defined as the 3-year average of annual 90th percentile values. The Administrator recognized that the evidence available in this reconsideration and described in the 2022 PA continue to provide support for the short-term nature of PM-related visibility effects. Considering the available analyses of 24-hour and subdaily PM
With regard to the form of the visibility index, the Administrator noted that, consistent with the approach taken in other NAAQS, including the current secondary 24-hour PM
With regard to the level of the visibility index, the Administrator first noted that the scientific evidence that is available to inform the level of the visibility index is largely the same as in previous reviews, and continues to provide support for a level within the range of 20 to 30 dv (88 FR 5659-5660, January 27, 2023). The Administrator recognized that significant uncertainties and limitations remained, in particular those related to the public preference studies, including methodological differences between the studies, and that the available studies may not capture the full range of visibility preferences in the U.S. population (88 FR 5659-5660, January 27, 2023). The Administrator also noted that, in their review of the 2021 draft PA, the CASAC recognized that a judgment regarding the appropriate target level of protection for the visibility index is based on a limited number of visibility preference studies, with studies conducted in the western U.S. reporting public preferences for visibility impairment associated with the lower end of the range of levels, while studies conducted in the eastern U.S. reporting public preferences associated with the upper end of the range (Sheppard, 2022a, p. 21 of consensus responses). The Administrator noted that there have long been significant questions about how to set a national standard for visibility that is not overprotective for some areas of the U.S. In establishing the Regional Haze Program to improve visibility in Class I areas, Congress noted that “as a matter of equity, the national ambient air quality standards cannot be revised to adequately protect visibility in all areas of the country.” H.R. Rep. 95-294 at 205. Thus, in reaching his proposed conclusion, the Administrator recognized that there are substantial uncertainties and limitations in the public preference studies that should be considered when selecting a target level of protection for the visibility index and took the uncertainties and variability inherent in the public preference studies into account. In so doing, the Administrator first preliminarily judged that, consistent with similar judgments in past reviews, it is appropriate to recognize that the secondary 24-hour PM
In preliminarily concluding that it remains appropriate in this reconsideration to define the target level of protection in terms of a visibility index based on estimated light extinction as described above (
The Administrator noted that the results of these updated analyses are consistent with the results from the 2012 and 2020 reviews (88 FR 5660, January 27, 2023). Regardless of the IMPROVE equation used, these analyses demonstrate that the 3-year visibility metric is at or below 28 dv in all areas meeting the current 24-hour PM
With regard to the adequacy of the secondary 24-hour PM
In reaching his proposed conclusions, the Administrator also recognized that the available evidence on visibility impairment generally reflects a continuum and that the public preference studies did not identify a specific level of visibility impairment that would be perceived as “acceptable” or “unacceptable” across the whole U.S. population. However, he noted that a judgment regarding the appropriate target level of protection would take into consideration the appropriate weight to place on the individual public preference studies. In so doing, he noted that placing more weight on the public preference study from Washington, DC, could provide support for a target level of protection at or near 30 dv, whereas placing more weight on the public preference study performed in the Phoenix, AZ, study could provide support for a target level of protection below 30 dv and down to 25 dv. While the Administrator noted that, in their review of the 2021 draft PA, the CASAC did not recommend revising the level of the current 24-hour PM
With respect to climate effects, the Administrator recognized that a number of improvements and refinements have been made to climate models since the time of the 2012 review. However, despite continuing research and the strong evidence supporting a causal relationship with climate effects (U.S. EPA, 2019a, section 13.3.9), the Administrator noted that there are still significant limitations in quantifying the contributions of the direct and indirect effects of PM and PM components on climate forcing (U.S. EPA, 2022b, sections 5.3.2.1.1 and 5.5). He also recognized that models continue to exhibit considerable variability in estimates of PM-related climate impacts at regional scales (
With respect to materials effects, the Administrator noted that the available evidence continues to support the conclusion that there is a causal relationship with PM deposition (U.S. EPA, 2019a, section 13.4). He recognized that deposition of particles in the fine or coarse fractions can result in physical damage and/or impaired aesthetic qualities. Particles can contribute to materials damage by adding to the effects of natural weathering processes and by promoting the corrosion of metals, the degradation of painted surfaces, the deterioration of building materials, and the weakening of material components. While some recent evidence on materials effects of PM is available in the 2019 ISA, the Administrator noted that this evidence is primarily from studies conducted outside of the U.S. in areas where PM concentrations in ambient air are higher than those observed in the U.S. (U.S. EPA, 2019a, section 13.4). The CASAC also noted the lack of quantitative information relating PM and material effects. Given the limited amount of information on the quantitative relationships between PM and materials effects in the U.S., and uncertainties in the degree to which those effects could be adverse to the public welfare, the Administrator preliminarily judged that the scientific information available in this reconsideration remains insufficient to quantify, with confidence, the public welfare impacts of ambient PM on materials and that there is insufficient information at this time to revise the current secondary PM standards or to promulgate a distinct secondary standard to address PM-related materials effects (88 FR 5661, January 27, 2023).
Taken together, the Administrator proposed to conclude that the scientific and technical information for PM-related visibility impairment, climate impacts, and materials effects, with its attendant uncertainties and limitations, supports the current level of protection provided by the secondary PM standards as being requisite to protect against known and anticipated adverse effects on public welfare. For visibility impairment, this proposed conclusion reflected his consideration of the evidence for PM-related light extinction, together with his consideration of updated analyses of the protection provided by the current secondary PM
Of the public comments received on the proposal, very few were specific to the secondary PM standards. Of those commenters who did provide comments on the secondary PM standards, the majority support the Administrator's proposed decision to retain the current standards. Some commenters disagree with the Administrator's proposed conclusion to retain the current secondary standards, primarily focusing their comments on the need for a revised standard to protect against visibility impairment. In addition to the comments addressed in this notice, the EPA has prepared a Response to Comments document that addresses other specific comments related to setting the secondary PM standards. This document is available for review in the docket for this rulemaking and through the EPA's NAAQS website (
We first note that some commenters raise questions about the protection provided by the secondary PM standards for ecological effects (
Of the comments addressing the proposed decision for the secondary PM standards, many of the commenters support the Administrator's proposed decision to retain the current secondary PM standards, without revision. This group includes industries and industry groups and State and local governments and organizations. All of these commenters generally note their agreement with the rationale provided in the proposal, with a focus on the strength of the available scientific evidence for PM-related welfare effects. Most also recognize that the scientific evidence and quantitative information available in this reconsideration have not substantially altered our previous understanding of PM-related effects on non-ecological welfare effects (
The EPA received relatively few comments on the proposed decision that it is not appropriate to establish any distinct secondary PM standards to address PM-related climate effects. Several commenters agree that the available scientific evidence provides support for the 2019 conclusion that there is a causal relationship between PM and climate effects, and the commenters also agree with the EPA that the currently available information is not sufficient for supporting quantitative analyses for the climate effects of PM in ambient air. These commenters support the Administrator's proposed decision not to set a distinct standard for climate.
There were also very few commenters who commented on the proposed decision that it is not appropriate to establish any distinct secondary PM standards to address PM-related materials effects. As with comments on climate effects, commenters generally agree with the EPA that the evidence is not sufficient to support quantitative analyses for PM-related materials effects. However, some commenters contend that EPA failed to explain in the proposal how the current standard is appropriate to protect materials from the effects of PM. These commenters disagree with the EPA's conclusion that quantitative relationships have not been established for PM-related soiling and corrosion and frequency of cleaning or repair of materials, and cite to several studies conducted outside the U.S. that they contend that the EPA should consider since the same materials are present in the U.S. They further contend that, in discussing the available scientific evidence in the 2019 ISA for studies conducted outside of the U.S., the EPA did not provide references to these studies and, therefore, the public is unable to comment on these studies. They further State that EPA failed to consider the following information: (1) Recent work related to soiling of photovoltaic modules and other surfaces, and; (2) damage and degradation resulting from oxidant concentrations and solar radiation for a number of materials, including polymeric materials, plastic, paint, and rubber. These commenters further assert that the EPA failed to propose a standard that provides requisite protection against materials effects attributable to PM.
As an initial matter, we note that the commenters submitted the same comments related to materials effects during the 2020 review. Consistent with our response in the 2020 notice of final rulemaking (85 FR 82737, December 18, 2020), we disagree with the commenters that the EPA failed to consider the relevant scientific information about materials effects available in this reconsideration. The 2019 ISA considered and included studies related to materials effects of PM, including studies conducted in and outside of the U.S., on newly studied materials including photovoltaic modules that were published prior to the cutoff date for the literature search.
With regard to studies conducted outside of the U.S., including those referenced by the commenters, as described in the proposal, in reaching his proposed conclusion, the Administrator recognized that while there was some newly available information related to materials effects of PM included in the 2019 ISA, “this evidence is primarily from studies conducted outside of the U.S. in areas where PM concentrations in ambient air are higher than those observed in the U.S. (U.S. EPA, 2019a, section 13.4)” (88 FR 5661, January 27, 2023). We disagree with the commenters that EPA did not provide references for these studies, nor that the lack of references inhibited the public's ability to provide comment on this proposed conclusion. First, the reference to section 13.4 in the 2019 ISA is a direct citation to the evaluation of newly available studies on PM-related materials effects, which includes citations for all materials effects evidence considered in the 2020 review and in this reconsideration. Second, section 5.3.2.1.2 of the 2022 PA considers the available scientific evidence for PM-related materials effects—including citations to the studies newly available in the 2019 ISA—and how that evidence informs conclusions regarding the adequacy of the standard (U.S. EPA, 2022b, section 5.3.2.1.2). Therefore, the EPA disagrees that the proposal failed to provide the proper references to the studies conducted outside of the U.S., and that the public was not provided the opportunity to provide comment on these studies.
Moreover, we disagree with the commenters that the EPA failed to consider quantitative information from studies available in this reconsideration. As detailed in sections 5.3.2.1.2 and 5.3.2.2 of the 2022 PA, and consistent with the information available in the 2020 review, a number of new studies are available that apply new methods to characterize PM-related effects on previously studied materials; however, the evidence remains insufficient to relate soiling or damage to specific levels of PM in ambient air or to establish quantitative relationships between PM and materials degradation. The uncertainties in the evidence identified in the 2012 review persist in the evidence in the 2020 review and in this reconsideration, with significant uncertainties and limitations to establishing quantitative relationships between particle size, concentration, chemical components, and frequency of painting or repair of materials. While some new evidence is available in the 2019 ISA, overall, the data are insufficient to conduct quantitative analyses for PM-related materials effects. Quantitative relationships have not been established between characteristics of PM and frequency of repainting or cleaning of materials, including photovoltaic panels and other energy-efficient materials, that would help inform our understanding of the public welfare implications of soiling in the U.S. (U.S. EPA, 2022b, section 5.3.2.2.2; U.S. EPA, 2019a, section 13.4). Similarly, the information does not support quantitative analyses between microbial deterioration of surfaces and the contribution of carbonaceous PM to the formation of black crusts that contribute to soiling (U.S. EPA, 2022b, section 5.3.2.2.2; U.S. EPA, 2019a, section 13.4). We also note that quantitative relationships are difficult to assess, in particular those characterized using damage functions as these approaches depend on human perception of the level of soiling deemed to be acceptable and evidence in this area remains limited in this reconsideration (U.S. EPA, 2022b, section 5.3.2.1.2). Additionally, we note the CASAC's concurrence with conclusions in the 2020 PA (Cox, 2019b, p. 13 of consensus responses) and the 2022 PA (Sheppard, 2022a, p. 23 of consensus responses) that uncertainties remain about the best way to evaluate materials effects of PM in ambient air. Further, no new studies are available in this reconsideration to link human perception of reduced aesthetic appeal of buildings and other objects to materials effects and PM in ambient air. Finally, uncertainties remain about deposition rates of PM in ambient air to surfaces and the interaction of PM with copollutants on these surfaces (U.S. EPA, 2022b, section 5.6).
With respect to the commenters' assertion that the EPA failed to consider information related to materials damage and degradation from oxidant concentrations and solar radiation for a variety of materials, we first note that, even assuming these sources of materials damage are within the scope of this review of the PM NAAQS, the commenter did not provide any references to the scientific studies that they suggest that the EPA did not consider. Despite the lack of a list of specific references from the commenter, we note that the 2019 ISA considered a number of studies that examined the
As summarized above and in the proposal, the evidence in the 2020 review and in this reconsideration for PM-related effects on materials is not substantively changed from that in the 2012 review. There continues to be a lack of evidence related to materials effects that establishes quantitative relationships and supports quantitative analyses of PM-related materials soiling or damage. While the information available in the 2020 review and in this reconsideration continues to support a causal relationship between PM in ambient air and materials effects (U.S. EPA, 2019a, section 13.4), the EPA is unable to relate soiling or damage to specific levels of PM in ambient air and is unable to evaluate or consider a level of air quality to protect against such materials effects. Although the EPA did not propose a distinct level of air quality or a national standard based on air quality impacts (88 FR 5662, January 27, 2023), we did identify data gaps that prevented us from doing so. The EPA identified a number of key uncertainties and areas of future research (U.S. EPA, 2022b, section 5.6) that may inform consideration of the materials effects of PM in ambient air in future reviews of the PM NAAQS. The EPA notes that one commenter objected to the Administrator's proposed conclusion in the proposal (88 FR 5661, January 27, 2023) that in light of the available evidence for PM-related impacts on climate and on materials that it is appropriate not to change the existing secondary standards at this time. The EPA has explained, in both the proposal and this final action, the basis for its conclusion that there is insufficient evidence to identify any particular secondary standard or standards that would provide requisite protection against climate effects or materials damage. The EPA acknowledges that, as a result, the adoption of any distinct secondary PM standards for those effects would be inconsistent with the requirements of the CAA. The EPA is clarifying that it is not basing its decisions on secondary standards in this reconsideration to address these welfare effects because it has concluded that the available scientific evidence is insufficient to allow the Administrator to make a reasoned judgment about what specific standard(s) would be requisite to protect against known or anticipated adverse effects to public welfare from PM-related materials damage or climate effects.
Some commenters agree with the Administrator's proposed conclusion that a target level of protection for visibility of 30 dv and the level of the secondary 24-hour PM
With regard to the commenters' assertion that the current secondary standards are inadequate to protect the public welfare from PM-related visibility impairment, the EPA disagrees that the currently available information is sufficient to suggest that a more stringent standard is warranted. The EPA identified and addressed in great detail the limitations and uncertainties associated with the public preference studies as a part of the 2012 review (78 FR 3210, January 15, 2013). Given that the evidence related to public preferences has not substantially changed since the 2012 review, the EPA reiterated the limitations and uncertainties inherent in the evidence as a part of the 2020 PA (U.S. EPA, 2020b, section 5.5), as well as in the 2022 PA for this reconsideration (U.S. EPA, 2022b, section 5.6). The 2022 PA highlights key uncertainties associated with public perception of visibility impairment and identifies areas for future research to inform future PM NAAQS reviews, including those raised by the commenters (U.S. EPA, 2022b, section 5.6). Specifically, the EPA agrees with commenters that there are several areas where additional information would reduce uncertainty in our interpretation of the available information for purposes of characterizing visibility impairment. As described in more detail in the 2020 PA (U.S. EPA, 2020b, p. 5-41) and the 2022 PA (U.S. EPA, 2022b, p. 5-53), briefly, these areas include: (1) Expanding the number and geographic coverage of preference studies in urban, rural, and Class I areas; (2) evaluating visibility preferences of the U.S. population today, given that the preference studies were conducted more than 15 years ago, during which time air quality in the U.S. has improved; (3) accounting for the influence of varying study methods may have on an individual's response as to what level of visibility impairment is acceptable, and; (4) information on people's judgments on acceptable visibility based on factors that can influence their perception of visibility (
However, the EPA disagrees with the commenters that the current secondary PM standards are inadequate and should be made more stringent because of the limitations and uncertainties associated with the available public preference studies. The EPA does not view the limitations of the preference studies and other available evidence as so significant as to render the EPA unable to identify a secondary standard to protect against the adverse effects of PM on visibility, but the EPA also does not believe that the limitations themselves mean that the standards are inadequate. In fact, there is a limited amount of recently available scientific evidence to further inform our understanding of public preferences and visibility impairment is recognized by the Administrator in reaching his proposed decision not to change the current secondary PM standards at this time, given that the evidence base is largely the same as at the time of the 2012 and 2020 reviews.
These same commenters further contend that the EPA failed to use the latest science to develop a visibility index, stating that the EPA failed to consider the contrast of distance methodology employed in a recent meta-analysis of available preference studies (Malm et al., 2019). Commenters claim that the EPA draws conclusions from the Malm et al. (2019) study about how to relate contrast to acceptable visibility preferences in the 2022 ISA Supplement, yet ignores the findings of the study and fails to consider the “contrast of distance” methodology in the 2022 PA and the proposal, thereby, in their view, departing from the CASAC's advice to consider this evidence in setting the secondary
We disagree with the commenters that the EPA did not use the latest science in evaluating the visibility index, and that the EPA failed to consider the contrast of distance methodology used in Malm et al. (2019). As the commenters state, the Malm et al. (2019) study was included in the ISA Supplement (U.S. EPA, 2022a, section 4.2.1). However, the EPA disagrees with the assertion that the ISA Supplement reached conclusions about how to relate contrast to acceptable visibility preferences. The ISA Supplement provided an overview of the Malm et al. (2019) study, stating that “[t]he main conclusion of this study was that the level of acceptable visual air quality is more consistent across studies using metrics that evaluate the distinction of an object from a background than using metrics that evaluate the greatest distance at which an object can be observed.” Furthermore, the statements that the commenters are referencing in support of this statement (
In reaching conclusions regarding the appropriate indicator for the visibility index, the 2022 PA specifically notes “that limited new research is available on methods of characterizing visibility or on how visibility is valued by the public, such as visibility preference studies. Thus, while limited new research has further informed our understanding of the influence of atmospheric components of PM
Some commenters suggests that the methodology could be approximated by simply ensuring that people could always see distant scenic elements, and that characterizing typical average and/or maximal viewing distances cross different geographical areas and regions would be a straightforward Geographical Information Systems (GIS) exercise. The EPA disagrees that this assessment would be straightforward, given the lack of data establishing viewing distances in the available scientific record and the diversity of distance to scenic elements across different areas and regions of the U.S., and finds that this approach is also not practical to adopt in this reconsideration. Finally, while the Malm et al. (2019) study is using an alternative approach for evaluating public preferences and acceptability, we note that this study is evaluating the same public preference studies that have been available for the past several decades. For these reasons, the EPA disagrees with the commenters' allegation that the EPA ignored the findings of the Malm et al. (2019) study and failed to consider the contrast of distance methodology in the 2022 PA and the proposal, and ignored the CASAC's advice to consider this study. The ISA Supplement and the 2022 PA considered the Malm et al. (2019) study, along with the full body of available scientific evidence, and took into account the uncertainties and limitations associated with the evidence for visibility preferences, in reaching conclusions regarding the adequacy of the secondary 24-hour PM
Several comments in support of revising the secondary 24-hour PM
As an initial matter, the EPA disagrees to the extent commenters are suggesting that the PA is legally required to analyze options for alternative standards. The PA is a document developed by the EPA in order to assist the Administrator and the CASAC in reaching conclusions regarding the adequacy of the current standards, and its scope is determined by the EPA. Moreover, the 2022 PA did assess a wide range of information relevant to the Administrator's decision and considered a range of potential standards.
First, in developing the 2022 PA and in responding to CASAC's advice and recommendations during its review of the 2021 draft PA, the EPA expanded upon its discussion of determining the target level of protection for the visibility index and considered the extent to which the available scientific information would alter regarding the visibility index and the appropriate target level of protection against PM-related visibility effects (U.S. EPA, 2022b, pp. 5-27-5-29). This detailed discussion expands the consideration of the target level of protection for the visibility index presented in the 2020 PA (U.S. EPA, 2020b) and the 2021 draft PA (U.S. EPA, 2021c), neither of which specifically considered the elements of the visibility index in determining the appropriate target level of protection. In
Additionally, in summarizing the air quality and quantitative information in the proposal for this reconsideration, the EPA further expands upon the discussion added to the 2022 PA related to the target level of protection in terms of a PM
Having provisionally concluded that it was appropriate to define the target level of protection in terms of a visibility index based on estimated light extinction as described above (
However, the Administrator additionally recognized that the available evidence on visibility impairment generally reflects a continuum and that the public preference studies did not identify a specific level of visibility impairment that would be perceived as “acceptable” or “unacceptable” across the whole U.S. population. He noted a judgment of a target level of protection, below 30 dv and down to 25 dv, could be supported if more weight was put on the public preference study performed in the Phoenix, AZ, study (BBC Research & Consulting, 2003). As described above, while the Administrator noted that the CASAC did not recommend revising the level of the current 24-hour PM
With regard to the elements of the visibility index, in considering the adequacy of the current secondary 24-hour PM
In defining this target level of protection, the Administrator first considered the indicator of such an index. He noted that, given the lack of availability of methods and an established network for directly measuring light extinctions, a visibility index based on estimates of light extinction by PM
Some commenters who criticized the EPA's interpretation and application of the Malm et al. (2019) study also contend that an indicator based on the contrast of distance would be a significant improvement over the current indicator for the visibility index and would more accurately evaluate public preferences. However, as described in the 2022 PA (U.S. EPA, 2022b, section 5.3.1.1), while scene-dependent metrics, such as contrast, may be useful alternative predictors of preferences compared to universal metrics like light extinction, there are a very limited number of studies that use such metrics to evaluate public preferences of visibility impairment and there is a lack of scientific evidence that supports one metric over another. Moreover, the EPA finds that even if the Administrator agreed that the contrast of distance methodology was an improvement over light extinction, there is insufficient information available to evaluate and adopt contrast of distance as an indicator for a national visibility target at this time. While, in its review of the 2021 draft PA the CASAC suggested that the EPA consider this method in developing the secondary PM standards, the CASAC also noted that “more extensive technical evaluation of the alternatives for visibility indicators and practical measurement methods” is needed to inform future reviews of the secondary PM standards (Sheppard, 2022a, p. 22 of consensus responses). The CASAC did not recommend using a different indicator for this reconsideration, with the majority of CASAC members reiterated past advice recommending development of a visibility FRM for a directly measured PM
With regard to averaging time, some commenters suggested to the EPA that a secondary standard with a different form than the primary standard may be a more relevant for welfare effects. While they do not recommend a specific alternative form, the commenters point to CASAC advice in past reviews where the CASAC stated that a subdaily standard based on daylight hours better reflects visibility impairment.
In defining the characteristics of a visibility index, the EPA continues to believe that a 24-hour averaging time is reasonable. This is in part based on analyses conducted in the 2012 review that showed relatively strong correlations between 24-hour and subdaily (
Moreover, the EPA disagrees with commenters that a secondary PM
With regard to the form of the visibility index, some commenters contend that the form used in evaluating visibility impairment is not appropriate. First, commenters contend that the EPA incorrectly stated that the CASAC did not provide advice on the 3-year, 90th percentile form of the visibility index and that the CASAC specifically recommended that the EPA further justify the metric and form, and by not doing so, the proposal arbitrarily departs from the CASAC's recommendations. The commenters also contend that the EPA fails to explain how averaging the form over three years is protective given that the public does not perceive visibility in three-year averages.
We disagree with the commenters that the EPA departed from the CASAC's recommendations that “[t]he final PA should provide a robust justification for the daily light extinction percentile used in the analysis” (Sheppard, 2022a, p. 22 of consensus responses). In this statement, the CASAC did not make explicit recommendations for revisions to the form of the visibility index, as the commenters assert, but rather requested additional justification for the percentile selected for the visibility index in the 2022 PA. In response to the CASAC's recommendation after reviewing the 2021 draft PA, the EPA included a new section in the 2022 PA that explicitly discusses the elements (
Some commenters suggest that the 90th percentile form is too low and would result in 36 days being excluded annually, presuming that the public only finds it objectionable when visibility is worse than the standard on 37 or more days per year. The commenters also contend that the EPA's approach of using a 90th percentile form for the visibility index is inconsistent with the goals of the Regional Haze Program. In so doing, the commenters note that the Regional Haze Rule focuses on improving conditions on the worst days, while they argue that a 90th percentile form for the visibility index would ignore the 36 worst visibility days, rather than identifying them and reducing pollution on those days.
In reaching conclusions regarding the appropriate form of the visibility index, the EPA is following the same approach employed in past reviews of the secondary PM NAAQS, including those in the 2012 and 2020 rulemakings. In reaching conclusions regarding the appropriate form of the visibility index in the 2011 PA, the EPA considered the percentile forms of the visibility index assessed in the 2010 PA (
Some commenters suggest that the analyses conducted in the 2010 UFVA are based on a different metric than the 24-hour average being considered in the reconsideration, that the analyses are outdated and irrelevant. Therefore, the commenters assert that relying on the analyses in the 2010 UFVA is not a rational justification for the use of a 90th percentile for the visibility index in this reconsideration. Moreover, these commenters state that, in past reviews, both the EPA and the CASAC have considered and recommended a 98th percentile form, but the proposal does not consider the 98th percentile.
These commenters assert that the 2010 UFVA was not considering the same metric under consideration here. However, the EPA was citing to the 2010 UFVA for the conclusion that there are correlations between different statistical forms of the visibility index. To confirm whether these correlations occur under recent air quality, we conducted additional air quality analyses evaluating the visibility index using the current percentile form (
Some commenters disagree with the EPA's proposed conclusion that a level of 30 dv is appropriate for the visibility index and support a lower level in order to provide increased protection against visibility impairment. Commenters who support a revised level for the visibility index state that a target level of protection of 30 dv would mean that less than 10% of participants in the public preference studies, other than the Washington, DC, study, would accept visibility conditions above 29 dv. These commenters further suggest that a 75% acceptability, rather than 50% acceptability, is requisite to protect visibility sources, which would be on average a level of 21 dv when using the light extinction method or 18 dv when using the contrast of distance method. These commenters argue that, based on the available information, a target level of protection for the visibility index of approximately 20 dv would be more appropriate, and therefore, the level of the secondary 24-hour PM
Some commenters state that EPA's justification for setting a target level of protection at the upper end of the 20 to 30 dv range is arbitrary. These commenters state that the EPA's reliance on the standard operating in many regions and circumstances as support for the upper end of the range is irrational and illegal. Moreover, these commenters contend that EPA provided no rational connection between the Regional Haze Program and the proposed decision to set the target level of protection at the upper end of the range. They suggest that the EPA proposed to rely exclusively on the Regional Haze Program to protect visibility in Class I areas and to give visibility in these areas no weight in considering the secondary PM standard and that it is not rational to entirely ignore visibility in Class I areas when setting the secondary standard. These commenters assert that the Regional Haze Program provides no rational basis for a target level of protection at the upper end of the range, nor does the EPA identify one.
Some commenters contend that the EPA failed to justify the adequacy of the current secondary annual PM
The EPA recognizes that the selection of the target level of protection for the visibility index is fundamentally a public welfare policy judgment for the Administrator. The Administrator is tasked by the CAA to judge when visibility impairment becomes an adverse effect on public welfare. It is clear that visibility impairment can become adverse to public welfare, but the Administrator does not consider that every deciview of impairment is adverse to public welfare. In considering the point at which visibility impairment becomes adverse to public welfare, such that the attainment of the secondary PM NAAQS would prevent the adverse effect, the Administrator gives weight to the public preference studies as to when visibility impairment is unacceptable. At the same time, the Administrator recognizes the limitations of these studies, which have been detailed in the proposal and the 2022 PA. Similarly, the EPA discussed the Regional Haze program in the proposal to highlight that there is a distinct program to protect against visibility impairment in Class I areas, and the existence of that program is relevant to the Administrator's judgment about the level of visibility impairment that is adverse to public welfare under CAA 109(d), because in determining what is requisite the Administrator is primarily considering visibility impairment outside of Class I areas.
In considering how to use the results of the public preference studies, the Administrator concludes that a 50th acceptability criterion is an appropriate tool. The Administrator's task is to set standards that are neither more stringent nor less stringent than necessary, and a 50% acceptability criterion seems most appropriate to use in judging when visibility impairments become adverse, because it should more closely represent when the median person would find the impairment to be adverse. The Administrator notes this conclusion is consistent with the approach adopted in the Denver study by Ely et al. (1991) where the 50% acceptability criterion for urban visibility was first presented. This study discussed the use of the 50% acceptability criteria as a reasonable basis for setting a standard to protect visibility in urban areas. In doing so, Ely et al. (1991) noted that the 50% acceptability criterion divided the slides into two groups—those judged acceptable and those judged unacceptable by a majority of people in the study—and therefore, was reasonable since it defines the point where the majority of the study participants began to judge levels of visibility impairment as unacceptable (Ely et al., 1991).
In considering the appropriate target level of protection, we next look to the available public preference studies, noting that the selecting of the range of 20 to 30 dv for the target level of protection for the visibility index is informed by the 50% acceptability values from these studies. The Denver, CO, (Ely et al., 1991) and British Columbia, Canada, (Pryor, 1996) studies met the 50% acceptability criteria at 20 dv and 19-23 dv, respectively (U.S. EPA, 2022b, Table D-8). As described in the proposal, these studies used photographs that were taken at different times of the day and on different days to capture a range of light extinction levels needed for the preference studies (88 FR 5652, January 27, 2023). Compared to studies that used computer-generated images (
In so doing, we focus on the public preference studies that use computer-generated images (
The Phoenix, AZ, public preference study (BBC Research & Consulting, 2003) had several strengths compared to some of the other public preference studies. The Phoenix, AZ, study had the largest number of participants (385 in 27 separate focus group sessions) of all of the public preference studies, with a sample group designed to be demographically representative of the Phoenix population at that time. The age range in the Phoenix study was also more inclusive (18-65+), with the distribution of the study participants corresponding reasonably well to the overall age distribution in the 2000 U.S. Census for the Phoenix area (BBC Research & Consulting, 2003). Furthermore, the 21 images used in the Phoenix, AZ, study were developed using the WinHaze software with visual air quality ranging from 15 to 35 dv, and the view was toward the southwest, including downtown Phoenix, with the Sierra Estrella Mountains in the background at a distance of 25 miles. This study had the least noisy preference results, perhaps because a larger, more representative group of participants combined with the use of computer-generated images resulted in the smoother distribution of responses of “acceptable” visual air quality. Based on the EPA's evaluation of the public preference studies in the 2012 review, the 50% “acceptable” criteria was met at approximately 24 dv (U.S. EPA, 2010, Table 2-3).
We also consider the public preferences for the Washington, DC, studies (Abt Associates, 2001; Smith and Howell, 2009). The 2001 Washington, DC study included nine participants, and the 2009 Washington, DC, study replicated the 2001 study with 26 additional participants. Similar to the Phoenix study, the Washington, DC, studies also had the strength of having the 20 images included in the study generated using WinHaze with visual air quality ranging from 9 to 45 dv. The study depicted a scene of a panoramic view of the Potomac River, the National Mall, and downtown Washington, DC. All of the distinct buildings in the scene were within four miles and the higher elevations in the background were less than 10 miles from where the image was taken from the Arlington National Cemetary in Virginia. The 50% “acceptable” criteria was met at approximately 29 dv (U.S. EPA, 2010, Table 2-3).
As described in more detail in the proposal, visibility preferences can vary by location, and such differences may arise based on the differences in the cityscape scene that is depicted in the images (88 FR 5652, January 27, 2023). In considering the geographical differences between the public preference studies, we recognize that the methodological differences between the studies may influence the resulting “acceptable” level of visibility impairment. In the Phoenix, AZ, study, the image depicted mountains in the background and urban features in the foreground, whereas the Washington, DC, study depicted nearby buildings in the image without mountains in the distance. As an initial matter, we note that the object of interest to the study participant could differ across the studies based on the scenes included in the images being evaluated—with the mountains being of greater interest in the images in the Phoenix, AZ, study, despite also depicting buildings that are similar to those shown and presumed to be of interest in the images in the Washington, DC, study (88 FR 5652, January 27, 2023). We also agree with the commenters that the distance between the object of interest and the camera is an important consideration in
However, we note that these uncertainties and limitations have persisted from past reviews, and there is very little new information to inform conclusions regarding the interpretation of these results with regard to the target level of protection. In selecting a target level of protection, and in considering the CASAC's advice in their review of the 2021 draft PA and public comments, we conclude that it is appropriate to consider the information from the public preference studies in Washington, DC, and Phoenix, AZ, and in so doing, that it is appropriate to place weight on both of these studies in reaching conclusions on the appropriate target level of protection. The EPA recognizes that the scenes depicted in these two studies are different and may influence public preferences of visibility impairment, but notes these studies can be considered together as providing information about different areas across the U.S. with variations in the scenes that people are likely to most commonly encounter. The scene depicted in the images used in the Washington, DC, study have a mix of buildings, landmarks, and open space. On the other hand, the scene depicted in the Phoenix, AZ, study included a mix of buildings in the foreground and with more distant mountains in the background. The Administrator considers it appropriate to consider these studies together because in combination, they provide a greater diversity of scenes, which is more likely to be representative of scenes people typically experience around the country (
The Administrator next considers what target level of protection would be appropriate based on the available information from these public preference studies. He first recognizes that, in the 2012 and 2020 final decisions, the then-Administrators selected a target level of protection of 30 dv, based on the upper end of the range. In so doing, the then-Administrators judged that it was appropriate to place more weight on the uncertainties associated with the public preference studies in reaching their conclusions. However, in this reconsideration, the current Administrator, while continuing to recognize that substantial uncertainties remain and that there is relatively limited new information regarding public preferences of visibility impairment, judges that it is important to balance the weight placed on uncertainties with the strength of the scientific evidence. As such, the Administrator concludes that it is appropriate to consider a target level of protection within the range of 20 to 30 dv. He further concludes that in selecting a target level within that range it is appropriate to place weight on both the mid-point of the range, as supported by the study in Phoenix, AZ, as well as the upper end, as supported by the Washington, DC, study. The Administrator notes that these two studies both employ similar methodologies that are subject to fewer uncertainties than older public preference studies (including their use of WinHaze to reduce uncertainties in the preference solicitations) although he notes that the Phoenix, AZ, study yielded the best results of the four public preference studies in terms of the least noisy preference results and the most representative selection of participants. Furthermore, he notes the differences between the scenes used for each study and finds that consideration of these studies together is more appropriate in selecting a national target for visibility protection than considering either study alone. Thus, in considering this information, along with the uncertainties and limitations of the public preference studies, the Administrator judges that it would be appropriate to select a target level of protection based on placing equal weight on the upper end of the range (
The Administrator notes that the available evidence indicates that the relationship between PM and light extinction is complex, depending on factors such as PM composition, size fraction, and age of the particles in ambient air, as well as relative
The Administrator notes that when light extinction is calculated using the original IMPROVE equation, all 60 sites have 3-year visibility metrics below 28 dv, 58 sites are at or below 25 dv, 26 sites are at or below 20 dv, and of the two sites above 25 dv one is at 26 dv and the other has a 24-hour PM
We also note that the four areas that exceed the secondary 24-hour PM
The Administrator recognizes that in concluding that it is appropriate to identify secondary PM standards that generally limit visibility impairment to as low as 27 dv in terms of the visibility index, the current secondary PM standards continue to provide protection against visibility impairment associated with a visibility index as low as, or even lower than, 27 dv. In so doing, he notes that when meeting the current 24-hour PM
Thus, the Administrator concludes that weight on both the upper end of the range of target levels of protection for the visibility index identified in previous reviews and the mid-point of the range, as presented by the Phoenix, AZ, public preference study, and focusing on a target level of protection of 27 dv, he still judges the current secondary 24-hour PM
The EPA agrees with the commenters that the secondary PM standards work together to provide protection against short- and long-term effects of both fine and coarse particles (U.S. EPA, 2022b, section 5.5; 88 FR 5661, January 27, 2023). However, the EPA disagrees with commenters that we failed to discuss the secondary annual PM
This section summarizes the Administrator's considerations and conclusions related to the current secondary PM
Given these requirements, the Administrator's final decision in this reconsideration is a public welfare policy judgment that draws upon the scientific and technical information examining PM-related visibility impairment, climate effects and materials effects, including how to consider the range and magnitude of uncertainties inherent in that information. The Administrator recognizes that his final decision is based on an interpretation of the scientific evidence and technical analyses that neither overstates nor understates their strengths and limitations, or the appropriate inferences to be drawn. In particular, the Administrator notes that the assessment of when visibility impairment is adverse to public welfare requires a public welfare policy judgment informed by available scientific and quantitative information.
In considering the adequacy of the current secondary PM standards in this reconsideration, the Administrator has carefully considered the: (1) Policy-relevant evidence and conclusions contained in the 2019 ISA and 2022 ISA Supplement; (2) the quantitative information presented and assessed in the 2022 PA; (3) the evaluation of this evidence, the quantitative information, and the rationale and conclusions presented in the 2022 PA; (4) the advice and recommendations from the CASAC; and (5) public comments. In the discussion below, the Administrator gives weight to the 2022 PA conclusions, with which the CASAC generally concurred during their review of the 2019 draft PA and 2021 draft PA, as summarized in section IV.B.1 of the 2020 final notice and section V.D.1 of the 2022 proposal, and takes note of key aspects of the rationale for those conclusions that contribute to his decision in this reconsideration. After giving careful consideration to all of this information, the Administrator judges that no change is required for the secondary PM standards at this time.
In considering the 2022 PA evaluations and conclusions, the Administrator takes note of the overall conclusions that the non-ecological welfare effects evidence and quantitative information are generally consistent with what was considered in the 2020 final decision and in the 2012 review (U.S. EPA, 2022b, section 5.5). The scientific evidence for non-ecological welfare effects in this reconsideration is largely the same as that available in the 2019 ISA and 2020 PA. As described in section I.C.5.b above, the 2022 ISA Supplement included a limited number of newly available studies on PM-related visibility effects. This newly available evidence on visibility effects, along with the full body of non-ecological welfare effects evidence assessed in the 2019 ISA, reaffirms conclusions on the visibility, climate, and materials effects recognized in the 2020 final decision and in the 2012 review, including key conclusions on which the standards are based. Further, as discussed in more
With regard to the current evidence on visibility effects, as summarized in the 2022 PA and discussed in detail in the 2019 ISA and ISA Supplement, the Administrator notes the long-standing body of evidence for PM-related visibility impairment. As in previous reviews, this evidence continues to demonstrate a causal relationship between PM in ambient air and effects on visibility (U.S. EPA, 2019a, section 13.2). The Administrator recognizes that visibility impairment can have implications for people's enjoyment of daily activities and for their overall sense of well-being. Therefore, as in previous reviews, he considers the degree to which the current secondary standards protect against PM-related visibility impairment and the degree to which PM-related visibility impairment is adverse to public welfare. In particular, in recognizing the short-term nature of visibility impairment along with the fact that PM
As described in the proposal (88 FR 5658, January 27, 2023), the Administrator recognizes that the Regional Haze Program was established by Congress specifically to achieve “the prevention of any future, and the remedying of existing, impairment of visibility in mandatory Class I areas, which impairment results from man-made air pollution,” and that Congress established a long-term program to achieve that goal (CAA section 169A). In adopting section 169, Congress set a goal of eliminating anthropogenic visibility impairment at Class I areas, as well as a framework for achieving that goal which extends well beyond the planning process and timeframe for attaining the secondary PM NAAQS. Recognizing that the Regional Haze Program will continue to contribute to reductions in visibility impairment in Class I areas, consistent with his proposed conclusions, the Administrator concludes that addressing visibility impairment in Class I areas is largely beyond the scope of the secondary PM standards and that setting the secondary 24-hour PM
In further considering what standards are requisite to protect against adverse public welfare effects from visibility impairment, the Administrator concludes that it is appropriate to use an approach consistent with the approach used past reviews (88 FR 5650, January 27, 2023). He first identifies an appropriate target level of protection in terms of a PM visibility index that takes into account the factors that influence the relationship between PM in ambient air and visibility (
In reaching conclusions regarding the target level of protection, the Administrator first considers the characteristics of the visibility index and defines its elements (indicator, averaging time, form, and level). With regard to the indicator for the visibility index, the Administrator continues to recognize that, consistent with the conclusions of the 2022 PA and the CASAC's advice in their review of the 2021 draft PA, there is a lack of availability of methods and an established network for directly measuring light extinction. Therefore, the Administrator concludes that it continues to be appropriate to using an index based on estimates of light extinction by PM
Having reached the conclusion that estimated light extinction is the appropriate indicator for the visibility index, the Administrator next considers the appropriate averaging time and form of the index. With regard to the averaging time and form, the Administrator notes that in previous reviews, a 24-hour averaging time was selected and the form was defined as the 3-year average of annual 90th percentile values. As at the time of proposal, the Administrator recognizes that the available information continues to provide support for the short-term nature of visibility effects. He further recognizes that no new information is available in this reconsideration to inform his conclusions regarding averaging time, and therefore, he considers past analyses of 24-hour and subdaily PM
With regard to the form of the visibility index, the Administrator notes the approach in other NAAQS that a multi-year percentile form offers greater stability to the air quality management process by reducing the possibility that statistically unusual indicator values will lead to transient violations of the standard. He recognizes that using a 3-year average provides stability from the occasional effects of inter-annual meteorological variability (including relative humidity) that can result in unusually high pollution levels for a particular year (88 FR 5659, January 27, 2023) and recognizes that a stable standard contributes to the benefits of the NAAQS by ensuring that attainment strategies are designed to address non-transient problems and achieve durable air quality improvements. For these reasons, he concludes that a 3-year average continues to be appropriate.
In considering the percentile that would be appropriate with the 3-year average, the Administrator recognizes that there is very little new information available in this reconsideration to inform selection of an alternative form of the visibility index and that the appropriate form requires the exercise of public welfare policy judgment. In selecting the appropriate target level of protection for the visibility index, the Administrator is required to assess when visibility impairment becomes adverse to public welfare, weighing both the degree of visibility impairment (in dv) and the frequency of such impairment (through the form). As with the mass-based PM air quality standard, the target level of protection for the visibility index must be selected in conjunction with the form to determine the appropriate stringency. In so doing, consistent with approaches in past reviews, the Administrator first notes that the Regional Haze Program targets the 20% most impaired days for improvements in visual air quality in Class I areas, which are the days above the 80th percentile form of the visibility index. The Administrator concludes that a percentile form set at the 80th percentile would not be likely to sufficiently improve visual air quality on the worst days based on the visibility index. In considering the information available in past reviews regarding the form of the visibility index, as well as the analysis of alternative forms based on recent air quality discussed above, the Administrator notes that a 90th percentile form would represent the median of the distribution of the 20% most impaired days, and meeting a visibility index with a 90th percentile form would reasonably be expected to lead to improvements in visual air quality for days both above and below the 90th percentile (88 FR 5660, January 27, 2023). In reaching his conclusion that a 90th percentile would appropriately achieve improved air quality both above and below that percentile, the Administrator took into consideration assessments of air quality data and potential alternative percentiles for the form. The Administrator further notes that, consistent with the conclusions in the 2011 PA and 2020 PA, the 2022 PA concluded that there is no new information from public preference studies that would suggest that a 90th percentile form is not appropriate. The Administrator also considers air quality analyses described above in responding to public comments regarding the percentile form of the visibility index. In particular, the Administrator notes that while a higher percentile form (
With regard to the level of the visibility index, as at the time of proposal, the Administrator continues to recognize that there is very little new information available to inform his judgment regarding the range of levels of visibility impairment judged to be acceptable by at least 50% of study participants in the visibility preference studies,
However, at the time of proposal, the Administrator recognized that the available evidence on visibility impairment generally reflects a continuum and that the public preference studies do not provide information about the specific level for which visibility impairment would be “acceptable” or “unacceptable” across the country, and that alternative target levels of protection could be supported. At that time, in soliciting public comments, the Administrator recognized that other interpretations, assessments, and judgments based on the available welfare effects evidence for this reconsideration could be possible (88 FR 5662, January 27, 2023).
With regard to the appropriate target level of protection for the visibility index, the Administrator first notes that while the public preference studies were conducted in several geographical areas across the U.S., and they provide insight into regional preferences for visibility impairment, none of the studies identify a specific level of visibility impairment that would be perceived as “acceptable” or “unacceptable” across the whole U.S. population. He also noted that there have been significant questions about how to set a standard for visibility that is neither overprotective nor underprotective for some areas of the U.S. As described in the proposal (88 FR 5660, January 27, 2023), in establishing the Regional Haze Program to improve visibility in Class I areas, Congress noted that “as a matter of equity, the national ambient air quality standards cannot be revised to adequately protect visibility in all areas of the country.” H.R. Rep. 95-294 at 205. For the reasons noted above, in reaching his proposed decision regarding visibility impairment, the Administrator recognized that he is not seeking to set a standard that would eliminate visibility impairment in Class I areas, but significant uncertainties remain regarding how to judge when visibility impairment becomes adverse to public welfare across the range of daily outdoor activities for Americans across the country.
In reaching final conclusions regarding the available information, along with the CASAC's advice and public comments, the Administrator again considers what constitutes an appropriate target level of protection, and in particular considers whether a target level of protection below 30 dv is warranted. In so doing, he first notes the variability in public preferences of visibility impairment as demonstrated by the available public preferences, which support a range of potential target levels of protection for the visibility index from 20 to 30 dv. He also notes that this range informed the 2012 and 2020 then-Administrators final decisions that a target level of protection at the upper end of the range (
In this reconsideration, the Administrator judges that in determining when visibility impairment becomes adverse to public welfare for purposes of the secondary NAAQS, while continuing to recognize that substantial uncertainties remain and that there is relatively limited new information regarding public preferences of visibility impairment, it is important to balance the weight placed on uncertainties with the strength of the scientific evidence. In so doing, the Administrator first concludes that, consistent with previous reviews and his proposed decision, it remains appropriate to consider a target level of protection within the range of 20 to 30 dv. However, in further considering the available scientific and quantitative information, CASAC advice, and public comments, he further concludes that in selecting a target level within that range it is appropriate to place weight on both the middle of the range, as supported by the study in Phoenix, AZ, as well as the upper end, as supported by the Washington, DC, study. In so doing, he notes that the Washington, DC, and Phoenix, AZ, studies employ similar methodologies that are subject to fewer uncertainties than older public preference studies (including their use of WinHaze to reduce uncertainties in the preference solicitations) although he does note that the Phoenix, AZ, study yielded the best results of the four public preference studies in terms of the least noisy preference results and the most representative selection of participants. Further, the Administrator judges that this approach would take into account scenes that are similar to both the Washington, DC, study and Phoenix, AZ, study, which would be more representative of the “typical” scenes encountered across more areas of the U.S. than an approach that places weight on just one study or on studies conducted in certain geographical areas of the country. In considering this information, along with the uncertainties and limitations of the public preference studies, the Administrator judges that it would be appropriate to select a target level of protection based on placing equal weight on the upper end of the range (
In further considering the appropriate target level of protection for the visibility index, the Administrator again recognizes the complexity of the relationship between PM and light extinction which is dependent on a number of factors, including PM composition, size fraction, and age of the particles in ambient air, as well as relative humidity. As noted in responding to comments above, these factors can vary geographically across the U.S. and local or regional meteorological conditions can also vary spatially and temporally. These factors are critical inputs to the IMPROVE equation and can influence the resulting estimated light extinction such that it is not a straightforward comparison between estimated light extinction in one area of the country versus another. Moreover, the Administrator recognizes that there is variability in estimated light extinction depending on the version of the IMPROVE equation that is used. As described in more detail in the 2022 PA and the proposal, and in reaching his decisions on the indicator of the visibility index above, the Administrator notes that the 2022 PA concluded that one version of the IMPROVE equation is not more accurate or precise in estimating light extinction, and that difference in locations may support the selection of inputs into the IMPROVE equation or of the appropriate IMPROVE equation to estimate light extinction on a regional basis rather than on a national basis.
In considering the available information, including variations in both public preferences of visibility impairment and estimates of light extinction using one or more IMPROVE equation, as well as the CASAC's advice in their review of the 2019 draft PA and 2021 draft PA and public comments, the Administrator judges that a target level of protection of 27 dv would be appropriate. In so doing, he concludes that a target level of protection above 27 dv would not provide adequate protection against PM-related visibility impairment based on the 50% acceptability values when both the Washington, DC, and Phoenix, AZ, studies are considered. However, he also notes that when considering the 50% acceptability values from studies conducted in different areas of the U.S. and with different scenes and images depicted, the available public preference studies do not provide a “bright line” at and above which visibility impairment is considered adverse to public welfare. He further recognizes that, as discussed just above, there are a number of region-specific factors that can influence light extinction, and thereby influence visibility impairment, as well as variations in public preferences of visibility impairment based on the available studies, that complicate selection of a single target level of protection that would be appropriate for a national visibility index. While the Administrator recognizes that the uncertainties and limitations associated with public preferences of visibility and estimating light extinction have persisted over the last several PM NAAQS reviews, he also recognizes that in reaching conclusions regarding the appropriate target level of protection for the visibility index also involves public welfare policy judgments regarding how to appropriately consider the particular uncertainties around identifying when visibility impairment becomes adverse to public welfare, and the limitations on relying on the public preference studies.
The Administrator also places weight on the high degree of spatial and temporal variability in PM composition and relative humidity across the U.S. in considering a target level of protection. This approach of establishing a target level of protection that takes into account 50% acceptability values from both eastern and western sites is a more appropriate basis for determining the requisite level of protection against known or anticipated adverse effects on public welfare across diverse locations,
Having concluded that it is appropriate to identify a target level of protection in terms of a visibility index based on estimated light extinction as described above, the Administrator next considers the degree of protection from visibility impairment afforded by the current secondary PM standards. He considers the updated analyses of PM-related visibility impairment presented in the 2022 PA (U.S. EPA, 2022b, section 5.3.1.2) and described in section V.B.1.a of the proposal, and notes that the results of the analyses are consistent with the results from the 2012 and 2020 reviews.
Taking into consideration the full body of scientific evidence and technical information concerning the known and anticipated effects of PM on visibility impairment, the Administrator concludes that the current secondary PM
With regard to the adequacy of the secondary 24-hour PM
The Administrator recognizes that conclusions regarding the appropriate weight to place on the scientific and technical information examining PM-related visibility impairment, including how to consider the range and magnitude of uncertainties inherent in that information, is a public welfare policy judgment left to the Administrator. In reaching his final decision in 2020, the then-Administrator noted that the available evidence regarding visibility effects had changed very little since the 2012 review, specifically recognizing that, as evaluated in the 2019 ISA, there were no new visibility studies that were conducted in the U.S. and there was little new information available with regard to acceptable levels of visibility impairment in the U.S. (85 FR 82742, December 18, 2020). As such, the then-Administrator concluded that the protection provided by a standard defined in terms of a PM
With respect to climate effects, as at the time of proposal, the Administrator recognizes that a number of improvements and refinements have been made to climate models since the time of the 2012 review. However, despite continuing research and the strong evidence supporting a causal relationship with climate effects (U.S. EPA, 2019a, section 13.3.9), the Administrator notes that there are still significant limitations in quantifying the contributions of the direct and indirect effects of PM and PM components on climate forcing (U.S. EPA, 2022b, sections 5.3.2.1.1 and 5.5). He also recognizes that models continue to exhibit considerable variability in estimates of PM-related climate impacts at regional scales (
With respect to materials effects, the Administrator notes that the available evidence continues to support the conclusion that there is a causal relationship with PM deposition (U.S. EPA, 2019a, section 13.4). He recognizes that deposition of particles in the fine or coarse fractions can result in physical damage and/or impaired aesthetic qualities. Particles can contribute to materials damage by adding to the effects of natural weathering processes and by promoting the corrosion of metals, the degradation of painted surfaces, the deterioration of building materials, and the weakening of material components. While some recent evidence on materials effects of PM is available in the 2019 ISA, the Administrator notes that this evidence is primarily from studies conducted outside of the U.S. in areas where PM concentrations in ambient air are higher than those observed in the U.S. (U.S. EPA, 2019a, section 13.4). Given the limited amount of information on the quantitative relationships between PM and materials effects in the U.S., and uncertainties in the degree to which those effects could be adverse to the public welfare, the Administrator judges that the available scientific information
Taken together, the Administrator concludes that the scientific and quantitative information for PM-related non-ecological welfare effects (
For the reasons discussed above and taking into account information and assessments presented in the 2019 ISA, ISA Supplement, and 2022 PA, advice from the CASAC, and consideration of public comments, the Administrator concludes that the current secondary PM standards are requisite to protect public welfare from known or anticipated adverse effects and is not changing the standards at this time.
The EPA is finalizing revisions on data calculations in appendix K for PM
The EPA proposed to modify its data handling procedures for the 24-hour PM
The EPA received few comments on these proposed appendix K revisions, the majority of which were supportive.
One commenter was not supportive of the proposed appendix K revision to site-level PM
One commenter was not supportive of a footnote in the preamble of the NPRM stating that in the absence of a designated primary monitor at a given site, the default primary monitor would be one with the most complete data record (88 FR 5662, January 27, 2023). Because the procedure for calculating PM
Therefore, the EPA is finalizing these appendix K revisions as proposed.
The EPA proposed to modify its data handling procedures for the annual and 24-hour PM
The EPA received few comments on these revisions in the proposed rule, with most supportive of the appendix N revisions.
Although the EPA did not propose or request comment on this issue, one commenter suggested that appendix N be revised to only allow data from the primary monitor to be used in PM
Therefore, the EPA is finalizing these appendix N revisions as proposed.
The EPA is finalizing revisions to ambient air monitoring requirements for PM to improve the usefulness of and appropriateness of data used in regulatory decision making. These changes focus on ambient monitoring requirements found in 40 CFR parts 50 (appendix L), 53, and 58 with associated appendices (A, B, C, D, and E). These changes include addressing updates in the approval of reference and equivalent methods, updates in quality assurance statistical calculations to account for lower concentration measurements, updates to support improvements in PM methods, a revision to the PM
The EPA proposed a change to the FRM for PM
The EPA received only one comment regarding this proposed change, which was supportive. Therefore, the EPA is finalizing this change to Appendix L as proposed.
The EPA proposed to clarify the regulations associated with FRM and FEM applications for review by the EPA (88 FR 5664, January 27, 2023). Revisions were also proposed in instances where current regulatory specifications are no longer pertinent and require updating. In addition, the EPA proposed to correct a compiled a list of noted minor errors in the regulations associated with the testing requirements and acceptance criteria for FRMs and FEMs in part 53. These errors are typically not associated with the content of
The EPA proposed a change to 40 CFR 53.4(a) to update the delivery address for FRM and FEM Applications and Modification Requests, as well as update the name of the program responsible for their review (88 FR 5664, January 27, 2023). These revisions are due solely to organizational changes and do not affect the structure or role of the Reference and Equivalent Methods Designation Program in reviewing new FRM and FEM application requests and requests to modify existing designated instruments. The EPA received no comments on this revision and, therefore, the EPA is finalizing this revision as proposed.
The EPA proposed a change to 40 CFR 53.4(d), which currently allows the EPA to request only candidate PM
The EPA proposed a change to 40 CFR 53.4(b)(7) to specify that all written FRM and FEM application materials must be submitted to the EPA in English in MS Word format and that submitted data must be submitted in MS Excel format (88 FR 5664, January 27, 2023). The EPA received no comments on these revisions; therefore, the EPA is finalizing this section as proposed.
The EPA proposed a change to 40 CFR 53.8(a) to clarify the terms of new FRM and FEM methods to ensure that candidate samplers and analyzers are not publicly announced, marketed, or sold until the EPA's approval has been formally announced in the
The EPA proposed a change to 40 CFR 53.35(b)(1)(ii)(D) that involves field comparability tests for candidate Class III PM
The EPA proposed a change to 40 CFR 53.61(g), 53.62(e), and Table F-1 that involves the wind tunnel evaluation of candidate PM
Certain provisions of 40 CFR 53.14, Modification of a reference or equivalent method, incorrectly state an EPA response deadline of 30 days for receipt of modification materials in response to an EPA notice. Per a 2015 amendment (80 FR 65460, 65416, Oct. 26, 2015), all EPA response deadlines for modifications of reference or equivalent methods are 90 days from day of receipt. Thus, the EPA proposed a correction to specify the correct 90-day deadline (88 FR 5664, January 27, 2023).
Requirements for Reference and Equivalent Methods for Air Monitoring of Criteria Pollutants identifies the applicable 40 CFR part 50 appendices and 40 CFR part 53 subparts for each criteria pollutant. The four rows in the section for PM
Table B-1 specifies that the interference equivalent for each interferent is ±0.005 ppm for both the standard-range and lower-range limits, with the exception of nitric oxide (NO) for the lower-range limit per note 4. When testing the lower range of SO
After the EPA received an inquiry regarding the interaction of NO and O
Additionally, appendix A to subpart B of part 53 provides figures depicting optional forms for reporting test results. Figure B-3 lists an incorrect formula: the lower detectible limit section is missing the proper operator in the LDL calculation formula and Figure B-5 lists an incorrect calculation metric, and there is a typesetting error in the calculation of the standard deviation. The EPA proposed to correct the typesetting errors and noted other errors to be corrected in several formulas provided throughout § 53.43 (88 FR 5664, January 27, 2023).
The EPA proposed a revision to 40 CFR 53.43(a)(2)(xvi), 53.43(b)(2)(iv), and 53.43(b)(2)(iv) to correct typographical errors in equations.
The EPA proposed a revision to Table C-4 of part 53 Subpart C (88 FR 5700). This change is related to field comparability tests of candidate PM
The EPA received no comments on these proposed revisions; therefore, the EPA is finalizing the changes as proposed.
In the proposal, the EPA described how we evaluated the quality system as part of the PM NAAQS reconsideration (88 FR 5665, January 27, 2023). In this section, the EPA identified several areas for improvement in steadily declining average ambient PM
The EPA reconsidered the appendix A, section 2.3.1.1 goal for acceptable measurement uncertainty (88 FR 5665, January 27, 2023) for automated and manual PM
The EPA also proposed to update and clarify ambient air monitoring requirements found in 40 CFR part 58, appendix A, section 2.6.1 pertaining to EPA Protocol Gas standards used for ambient air monitoring and the Ambient Air Protocol Gas Verification Program (PGVP) (88 FR 5665, January 27, 2023). The EPA proposed to revise appendix A to clarify that in order to participate in the Ambient Air PGVP, producers of Protocol Gases must adhere to the requirements of 40 CFR 75.21(g), and only regulatory ambient air monitoring programs may submit cylinders for assay verification to the EPA Ambient Air PGVP. The EPA received mixed comments in support of and in opposition to this proposed revision. The sole commenter opposing the proposed revision indicated that the proposed PGVP requirements would be additional and is concerned with an increased resource burden. But the EPA responds that the PGVP requirements that were proposed to be added are consistent with the existing PGVP requirements in 40 CFR 75.21(g), and PGVP has been defined as a regulatory requirement since 2016 (81 FR 17263, March 28, 2016), so the proposed part 58 changes are not “additional” to existing regulations. After consideration of the comments, the EPA is finalizing the update and clarification of ambient air monitoring requirements found in appendix A, section 2.6.1 pertaining to EPA Protocol Gas standards used for ambient air monitoring and the Ambient Air PGVP as proposed.
The EPA proposed to remove section 3.1.2.2 from appendix A, which allows NO
The EPA proposed to revise the requirement in Appendix A, section 3.1.3.3 changing the National Performance Audit Program (NPAP) requirement for annual verification of gaseous standards to the ORD-recommended certification periods identified in Table 2-3 of the EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards (appendix A, section 6.0(4)) (88 FR 5665). The EPA received one comment supporting this change. As a result of the comment received and other general supportive comments regarding quality assurance, the EPA is finalizing the updated NPAP gaseous certification requirement in section 3.1.3.3 as proposed.
The EPA proposed to adjust the minimum value required by appendix A, section 3.2.4, to be considered valid sample pairs for the PM
The EPA proposed to change Equations 6 and 7 of appendix A, section 4.2.1 that are used to calculate the
Equation 6 as proposed at 88 FR 5666 (January 27, 2023) was:
As a result of the positive comments received and the correction to the equation made in response to some comments, the EPA is finalizing the updated Equation 6 as described and is finalizing Equation 7 as proposed for the calculation of the
The EPA proposed to update the appendix A, section 4.2.5, Equation 8, calculation for the Performance Evaluation Program Bias Estimate for PM
As a result of the supportive comments received and the correction to the equation in response to some comments, the EPA is updating and finalizing Equation 8 as described for the calculation for the Performance Evaluation Program Bias Estimate for PM
The EPA proposed to update the references and hyperlinks in appendix A, section 6 (88 FR 5667, January 27, 2023) to provide accuracy in identifying and locating essential supporting documentation and delete references to historical documents that do not represent current practices. The EPA received only favorable comments, and as a result, the EPA is finalizing the updated the references and hyperlinks in appendix A, section 6, as proposed.
The EPA also proposed to add a footnote to Table A-1 of part 58, appendix A—Minimum Data Assessment Requirements for NAAQS Related Criteria Pollutant Monitors (88 FR 5669, January 27, 2023). The proposed footnote clarifies the allowable time (
The EPA proposed to revise appendix B, Quality Assurance Requirements for Prevention of Significant Deterioration (PSD) Air Monitoring (88 FR 5667, January 27, 2023), in parallel to the proposal to revise appendix A. Thus, this section of the proposal included similar detail and proposed revisions related to evaluating quality system statistical calculations for PM
The EPA reconsidered the goal in appendix B, section 2.3.1.1 for acceptable measurement uncertainty for automated and manual PM
The EPA also proposed to update and clarify ambient air monitoring requirements found in 40 CFR part 58, appendix B, section 2.6.1 pertaining to EPA Protocol Gas standards used for ambient air monitoring and the Ambient Air PGVP (88 FR 5668, January 27, 2023). The EPA proposed to revise appendix B to clarify that in order to participate in the Ambient Air PGVP, producers of Protocol Gases must adhere to the requirements of 40 CFR 75.21(g), and only regulatory ambient air monitoring programs may submit cylinders for assay verification to the EPA Ambient Air PGVP. The EPA received comments in support of and in opposition to this proposed revision. The commenter opposing the revision indicated that the proposed PGVP requirements would be additional and is concerned with an increased resource burden. However, the EPA disagrees with the commenter because that the proposed PGVP requirements are consistent with the existing PGVP requirements in 40 CFR 75.21(g). PGVP has been defined as a regulatory requirement since 2016 (81 FR 17263, March 28, 2016), so the proposed part 58 changes are not “additional” to existing regulations. After consideration of the comments, the EPA is finalizing the update and clarification of ambient air monitoring requirements found in appendix B, section 2.6.1 pertaining to EPA Protocol Gas standards used for ambient air monitoring and the Ambient Air PGVP as proposed.
The EPA proposed to remove section 3.1.2.2 from appendix B, which allows NO
The EPA proposed to revise the requirement in Appendix B, section 3.1.3.3 changing the National Performance Audit Program (NPAP) requirement for annual verification of gaseous standards to the ORD-recommended certification periods identified in Table 2-3 of the EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards (appendix B, section 6.0(4)) (88 FR 5668, January 27, 2023). The EPA received one comment supporting this change. As a result of the comment received and other general supportive comments regarding quality assurance, the EPA is finalizing the updated NPAP gaseous certification requirement in section 3.1.3.3 as proposed.
The EPA proposed to adjust the minimum value required by appendix B, section 3.2.4, to be considered valid sample pairs for the PM
The EPA proposed to change Equations 6 and 7 of appendix B, section 4.2.1 used for calculating the
As a result of the positive comments received and the correction to the equation made in response to those comments, the EPA is finalizing the update to Equation 6 and retaining Equation 7 as proposed for the calculation of the
The EPA proposed to update the appendix B, section 4.2.5, Equation 8, calculation for the Performance Evaluation Program Bias Estimate for PM
As a result of the supportive comments received and the correction to the equation in response to some comments, the EPA is updating and finalizing Equation 8 as described for the calculation for the Performance Evaluation Program Bias Estimate for PM
The EPA proposed to update the references and hyperlinks in appendix B, section 6 (88 FR 5669, January 27, 2023) to provide accuracy in identifying and locating essential supporting documentation and delete references to historical documents that do not represent current practices. The EPA received only favorable comments, and as a result, the EPA is finalizing the updated the references and hyperlinks in appendix B, section 6, as proposed.
The EPA also proposed to add a footnote to Table B-1 of part 58, appendix B—Minimum Data Assessment Requirements for NAAQS Related Criteria Pollutant PSD Monitors (88 FR 5669, January 27, 2023). The proposed footnote clarifies the allowable time (
The EPA proposed to remove provisions for approval and use of Approved Regional Methods (ARMs) throughout parts 50 and 58 of the CFR (88 FR 5669, January 27, 2023). ARMs are continuous PM
The EPA received comments from multiple State air programs in support of the proposal to remove provisions for approval and use of ARMs. One commenter cites that there are multiple FEMs available for monitoring agencies to work with and that the agency was never able to get a candidate ARM to meet the requirements for approval. With the availability of multiple FEMs that now work in the monitoring agency's network, the commenting agency does not anticipate the need to ever pursue an ARM in the future and, therefore, suggests that the ARM provision is no longer needed. Another commenter strongly supported the proposed changes to remove the ARM provisions. The EPA also received comments from a few agencies that supported retaining the ARM provisions instead. One commenter cited the need to consider the rapid advancement of various new technologies and that, in some cases, approved continuous FEMs may have shortcomings, meaning that losing the ability to propose an ARM in the future may limit useful alternative options to monitoring agencies. Another commenter suggested that the removal of the ARM would take away the ability and right to use locally derived correction factors.
After considering the comments for and against removing the provisions for ARMs, the EPA believes it is most appropriate to remove the ARM provisions. As described in the proposal, when the EPA first proposed the process for approving and using ARMs, there were no continuous FEMs approved. There are now over a dozen approved PM
The EPA proposed to modify its specifications for PM FEMs in appendix C to Part 58 (88 FR 5670-73, January 27, 2023). Specifically, the EPA proposed that valid State, local, and Tribal (SLT) air monitoring data from Federal Reference Methods (FRMs) generated in routine networks and submitted to the EPA may be used to improve the PM concentration measurement performance of approved FEMs. This approach, initiated by instrument manufacturers, would be implemented as a national solution in factory calibrations of approved FEMs through a firmware update. This could apply to any PM FEM methods (
The EPA proposed this modification because there are some approved PM FEMs that are not currently meeting bias measurement quality objectives (MQOs) when evaluating data nationally as described in the 2022 PA (U.S. EPA, 2022b, section 2.2.3.1), meaning that an update to factory calibrations may be appropriate; however, there is no clearly defined process to update the calibration of FEMs. While there are several types of data available to use as the reference for such updates (
While the Agency proposed to add this language to more expressly define a process to update factory calibrations of approved PM FEMs, the EPA believes that the existing rules for updating approved FRMs and FEMs found at 40 CFR 53.14 may also continue to be utilized for this purpose, as appropriate. 40 CFR 53.14 allows instrument manufactures to submit to the EPA a “Modification of a reference or equivalent method.” Submitting a modification request may be appropriate to ensure an approved FEM continues to meet 40 CFR 53.9, “Conditions of designation.” Specifically, 40 CFR 53.9(c) requires that, “Any analyzer, PM
There are several technical components to EPA's proposed modification, including: the reference data to be used in the calibrations; implementing as a national solution in factory calibrations of approved FEMs through firmware updates; application to any PM FEM methods (
With the proposed modification, the EPA solicited input on these technical issues as well as the overall approach and any alternatives that could lead to more sites meeting the bias MQO with automated FEMs, especially for those sites that are near the level of the primary annual PM
Overall, there was broad and strong support from a majority of commenters for the proposed requirement to use FRM data generated in routine networks and submitted to the EPA to update factory calibrations included as part of approved FEMs. There were a smaller number of critical comments on the proposed process as well as some commentors that supported the proposed requirement but also provided additional suggestions for the EPA's consideration. Below, we address each of the areas on which the EPA requested comment regarding the calibration of PM FEMs, as well as a few additional areas where multiple commenters offered input on other areas related to our proposal.
A majority of the commenters on the proposed PM FEM calibration process support the process to use valid State, local, and Tribal FRM data generated in routine networks and submitted to the EPA to improve the PM concentration measurement performance of approved FEMs. Some commenters suggested that this action is needed to ensure that data reported from FRMs and FEMs are comparable and correction methods applied to data from FEM monitors are defensible across the national PM monitoring network. Others stated that they agree with the EPA that this is a critical step in the right direction to account for the discrepancies between PM
The EPA also received comments suggesting ways that the PM FEM correction could be performed, including through detailed analysis of data; by having PM FEM instrument manufacturers evaluate nationally available valid FRM data to update factory calibrations; and, by having the instrument manufacturers implement calibration adjustments at the factory.
The EPA also received supportive comments on the PM FEMs calibration relating to comparability to the NAAQS. For example, a commenter stated that it is important to ensure bias MQOs are met for FEMs run at sites potentially affected by revised standards as well as the need to accurately designate areas as attaining or not attaining the NAAQS. There were comments supporting the correction of PM FEM data as helping the EPA and SLT monitoring programs continue to evolve toward more automated methods. For example, one commenter appreciates the EPA's support for the ongoing move from filter-based PM
A small number of commenters were critical of the proposed FEM calibration approach. One commenter noted that EPA should further examine the handling of FEM PM
A few commenters provided specific recommendations for how the regulatory language could be improved. These included comments that the new regulatory language proposed for 40 CFR part 58, appendix C, section 2.2 must ensure consistency and transparency when requesting changes to the factory calibration; that the EPA should incorporate binding regulatory language in 40 CFR part 58, appendix C, section 2.2 (
In response to these comments, while the EPA agrees that the proposed regulatory language for 40 CFR part 58, appendix C, section 2.2 must ensure consistency and transparency when entities request changes to factory calibrations, the EPA disagrees that the regulations cannot also provide some flexibility. For example, we believe that a degree of flexibility is appropriate regarding whether outliers in the data to be used for factory calibration should or should not be included, the range of data to be included, and in utilizing collocated FRM and FEM data for updated calibrations from a representative set of geographic areas in which it is produced. The EPA believes that the proposal defined the core requirements needed to ensure all requests for updating FEM factory calibrations will follow the same process, using data of the same known quality and evaluating the effectiveness of the resulting correction factors consistently.
In its proposal, the EPA identified that while there are several types of data available to use as the reference for FEM calibration updates, including data from routinely operated FRMs, audit program FRMs, and PM
Overall, there was broad and strong support for utilizing collocated FRM data from routine SLT networks to provide calibrations of the continuous FEMs. For example, several commenters agree that valid SLT air monitoring data generated in routine networks and submitted to the EPA will improve the PM concentration measurement performance of approved FEMs. Another commenter provided support for PM FEM instrument manufacturers to evaluate nationally available valid FRM data as well as other data sets such as the performance evaluation audit program to update factory calibrations. The EPA believes that the routinely operated PM FRMs represent the best and largest source of data to calibrate continuous PM FEMs, and that performance evaluation audit program data should be kept independent of the calibration process. This will mean that assessments of the routine monitoring operations, including both the FRM and any future updated PM FEMs, will appropriately remain independent in evaluating whether updated methods are meeting bias MQOs. The EPA is, therefore, finalizing its approach to use routinely operated SLT FRMs as the basis of comparison upon which to calibrate continuous PM FEMs as proposed.
Regarding the EPA's proposed requirement to utilize factory calibrations (88 FR 5670-71, January 27, 2023), several commenters agreed that factory calibrations provide the best option to improve PM FEMs. For example, one commenter stated that the correction factors are necessary to preserve data integrity with the FRM, and they support the proposal that the approach be initiated by instrument manufacturers and implemented as a national solution through firmware updates.
Regarding the proposed requirement that calibrations be initiated by instrument manufacturers (88 FR 5671, January 27, 2023), most commenters were supportive of the proposed approach that recalibration of FEM PM instruments be initiated by instrument manufacturers. For example, one commenter stated they support allowing instrument companies submit improvements to their existing FEMs, as vendors should be encouraged to improve their methods. Another commenter noted that having a methodology initiated by the manufacturer will have nationwide consistency. A few of commenters recommended that SLT air agencies should have the additional ability to petition the EPA Administrator to initiate factory calibrations of FEMs to better meet MQOs when data collected by their agencies indicate disparities, because the monitoring agencies are responsible for the quality of the data from the specific makes and models of instrumentation used in their networks. While the EPA believes that, in most cases, the instrument companies should be the ones to initiate the process for calibration of FEMs to routinely operated FRMs, we agree with the commenters who suggested that other options should be available, including allowing monitoring agencies or MJOs to work independently or together to pursue improvements to designated FEMs. However, the EPA believes that any such improvements initiated by monitoring agencies or MJOs should still be facilitated through the responsible instrument company. Also, any such effort to improve data quality should be employed across all the networks in which the methods are operated and not limited to the networks operated by the agency(s) pursuing such improvements.
Regarding how frequently factory calibrations should be updated, our proposal identified that it would be most appropriate to not define a specific time period for updates; rather, updates should be based on whether or not quality data is being produced across a given network (88 FR 5672, January 27, 2023). Regarding this issue, one commenter recommended that instrument manufacturers be required to evaluate and, if necessary, adjust PM FEMs factory calibrations on an ongoing basis at regular intervals. The EPA notes that while it does not have the authority to require instrument companies to evaluate the quality of data from operating FEMs under 40 CFR part 58, the EPA does routinely participate in conferences and workshops and makes assessments of data quality specific to instrument makes and models publicly available. The EPA also regularly summarizes relevant FRM and FEM data
The EPA proposed that the calibration of FEMs could apply to any of the PM FEM method indicators (
The EPA proposed that either all data available or a range of data up to 125% of the 24-hour NAAQS for the PM indicator of interest may be used to establish new factory calibrations, (88 FR 5671-73, January 27, 2023). The EPA received many comments supportive of the proposal and one comment offering a different approach on the range of data to use. One commenter recommends that the EPA should consider using all “validated” data because how these instruments behave under normal operating ranges may be just as important as how they behave when monitoring conditions are low or elevated, and that the full range of data should be used when determining the appropriate level of the standard, just as the full range of data is used in determining if an area is attaining the standard. In response to this comment, the EPA believes that making allowances for some flexibilities will increase the likelihood of instrument companies pursuing such improvements. Also, even though there is flexibility, the EPA will still be able to evaluate the appropriateness of a range of concentration data included as part of each application submitted. Also, the EPA notes that in certain circumstances, States do petition the EPA to set aside data under the Exceptional Events Rule (§ 50.14, “Treatment of air quality monitoring data influenced by exceptional events”). Where approved, exceptional event data are set aside from use in regulatory decisions. Thus, there is a process to set aside certain high concentration data for certain purposes. Therefore, the EPA is finalizing the provision that factory calibrations may be based on a range of valid data as proposed.
The EPA solicited comment on the representative set of geographic locations to use in the calibration of FEMs compared to collocated FEMs (88 FR 5671, January 27, 2023). Most commenters were supportive of the approach of using representative sites in SLT networks from across the country. For example, several commenters provided their support for PM FEM instrument manufacturers to evaluate nationally available valid FRM data to update factory calibrations. Commenters disagreeing with a national geographic approach preferred to allow local solutions to correct data. For example, one commenter suggested having a local or regional option because PM instruments are impacted by, and respond differently to, a variety of local factors, including relative humidity, temperature, concentration levels, and particle composition. The EPA agrees that there are challenges in the response of PM FEMs to a variety of local factors; however, this can be true of many methods and are not specific to PM FEMs and, therefore, does not provide a reason to reject this approach in this instance. Another commenter stated that the proposed national correction factor is a “flawed concept,” suggesting that it is “widely understood throughout the monitoring community that monitors perform best with a local correction factor.” This commentor offered no record or citation supporting this point. The EPA counters that while monitoring agencies may statistically correct data from a PM continuous monitor for AQI purposes (40 CFR part 58, appendix G), there are both examples of well performing statistically corrected PM continuous monitors being used for AQI purposes; however, without proper attention and updates, there are also examples of poorly performing ones. Finally, another commenter believes that a national correction factor cannot possibly incorporate data to represent all the scenarios across the nation that have an impact on monitor performance and data quality. Although the EPA agrees that there are a variety of local scenarios that could affect monitor performance, the overall benefits of having nationally consistent measurement of PM concentrations and national calibration of data outweigh the potential advantages of locally specific calibrations.
Several commenters also disagreed with using local and regional calibrations of data, including some monitoring agencies that asserted being unable to reinvest in the operation of FRMs that would be required to locally calibrate their own PM FEMs. Further, every approved PM FEM method designated today is effectively calibrated through demonstration of field testing in the areas in which it was required to be tested (40 CFR 53.35(b)(1)). Moreover, the EPA proposed to require instrument manufacturers to demonstrate that they can improve the number of sites meeting bias MQOs by initiating a recalibration of an FEM. Thus, the use of a national set of sites where the methods are operated is essentially a fine-tuning of the PM FEMs performance across all sites where it is used.
After considering all the comments received, the EPA believes it is appropriate to finalize as proposed with a representative set geographic locations at SLT sites to calibrate PM FEMs. Identification of such sites would be made by the applicant of the planned updated calibration, subject to EPA approval, and submitted to the EPA in accordance with the requirements and application instructions in 40 CFR part 58, appendix C, sections 2.2 and 2.7. The EPA encourages early communication between an applicant seeking a method update and the EPA to facilitate the most appropriate sites are included in any updated application of the methods calibration.
The EPA proposed that instrument companies may, but are not required to, check for and exclude any potential outliers that may exist in the validated State, local, and Tribal agency network data available from AQS that would be used to establish new factory calibrations. The EPA received two comments regarding potential outlier approaches. One commenter disagreed with the proposed approach and instead recommended the use of all “validated” data, because how these instruments behave under normal operating ranges may be just as important as how they behave when monitoring conditions are low or elevated. The EPA acknowledges this point; however, the proposal on outliers allows flexibility in using standard outlier tests if needed to include or exclude such data as part of the calibration process. Ultimately, the true test of success for an updated method calibration will be that a higher number of sites are meeting bias MQOs in the areas in which the method is used, which will include all routine valid data including any potential outliers. Another commenter asserted concerns with the ability of instrument manufacturers to analyze data within individual monitoring agencies. The EPA disagrees with the commenter because decisions whether to include or exclude outliers should be flexible and made on a case-by-case basis. Moreover, the expected substantially larger dataset from routinely operated collocated FRMs and FEMs compared to what was
In contrast to these two comments, the EPA received many comments supportive of the proposed outlier approach overall. Therefore, the EPA is finalizing this part of the proposal that instrument companies may, but are not required to, check for and exclude any potential outliers that may exist in the validated State, local, and Tribal agency network data available from AQS that would be used to establish new factory calibrations.
Several commenters offered input on statistical criteria and initial testing requirements for approval of candidate PM FEMs and the role of instrument manufacturers in this process. The EPA did not propose any changes related to these issues; however, these comments have been considered below.
One commenter suggested that data quality objectives, bias, and precision estimators for different monitoring methods should be based on averages at both national and regional levels for purposes of comparison. Another commenter asked to strengthen the criteria for Class 3 Equivalency standards for candidate PM instrumentation. On testing requirements, one commenter recommended that the EPA consider updating the 40 CFR part 53 process for approving FEMs so that the testing process more closely reflects the regulatory deployment and data handling that generates NAAQS-comparable data. Another commenter asked that the results from “summer” and “winter” field evaluations not be averaged together because it allows agencies to minimize the error of biased instruments by averaging poor results with data often biased in the other direction. The same commenter also recommended that candidate instruments data sets should not be averaged together as is done currently where data from triplicate instruments are averaged for each day. Another commenter asked that the EPA require FEM field comparability tests in the northwest (
The EPA did not propose to make modifications to the statistical criteria or testing requirements; however, we did solicit comment on any alternatives that would lead to more sites meeting the bias MQO with automated FEMs, especially for those sites that are near the level of the primary annual PM
Regarding the comments related to the instrument companies' role in PM FEMs, the EPA notes that FEMs are already required to meet 40 CFR 53.9, “Conditions of designation.” Specifically, 40 CFR 53.9(c) requires that, “Any analyzer, PM
In addition to these few recommendations, the EPA received many comments supportive of the proposal that valid State, local, and Tribal air monitoring data from FRMs generated in routine networks and submitted to the EPA may be used to improve the PM concentration measurement performance of approved FEMs; therefore, consistent with the proposal we are not finalizing any updates to the statistical criteria, testing requirements, or requirements on instrument manufactures as proposed.
The EPA proposed that any new factory calibration should be developed using data from at least 2 years and tested on a separate year(s) of data (88 FR 5672, January 27, 2023). Comments on this part of the proposal were generally supportive. One commenter requested that at least a 3-year dataset, rather than the proposed 2 years, be used for a representative design value comparison of the FEM and FRM datasets to be evaluated. Another commenter pointed out that as large a data set as possible should be used, but EPA should not limit it to only data collected by instruments that have operated for more than 2 years.
In response to these comments, the EPA notes the broad support for the proposal as written. Also, the EPA notes that the 2-year period for using data to develop a factory calibration is a minimum, and that more years may be used as appropriate. Therefore, the EPA is finalizing its approach that any new factory calibration should be developed using data from at least 2 years and tested on a separate year(s) of data as proposed.
The EPA proposed several aspects of the FEM calibration on which we did not receive specific comments, including a provision that FEM methods should be evaluated by monitoring agencies as part of routine data assessments, such as during certification of data and 5-year assessments; the fact that the EPA recognizes only data from existing operating sites are available for use in factory calibrations; and recognition that an updated factory calibration does not have to work with the original field study data submitted that led to the designation as an FEM. With the broad general support from commenters summarized above, the EPA is finalizing each of these
In the proposal, the EPA identified that we should expect a lag between the date when an already designated method is approved with a new factory calibration as an updated method by the EPA and when it can be implemented in the field. The EPA solicited comment on how to approach the data produced during this lag. Commenters provided input not only on how to address data during the lag, but also regarding how to address data already collected prior to a method update that has the potential to be used in regulatory decision making, particularly where such collected data do not meet the bias MQO. In response to this solicitation of comment, there was a consistent recommendation that calibrations of data associated with method updates should be applied to all relevant PM data prior to the EPA using it for designations under a final NAAQS.
While the EPA appreciates these comments and recognizes their support for retroactive data correction, at this time and following this final rule, monitoring agencies should continue to report PM FEM data as measured. This component of this final rule is focused only on revising 40 CFR part 53, appendix C to implement an updated calibration for approved PM FEMs. The issue of how prior and future monitoring data will be used in the implementation of this NAAQS, such as for designations, and for air quality regulatory programs is outside the scope of this rulemaking and will therefore be addressed by the EPA in a subsequent relevant action or actions.
The EPA received comments on whether updates to PM FEM methods should be required to be implemented or there would flexibility in when and if a monitoring agency implemented them. The commenters asked that EPA be flexible in allowing the use of updated method correction factors intended to improve the data comparability between the FRMs and FEMs.
In most cases, the EPA expects that updating the FEMs will result in improved data quality and more sites meeting bias MQOs; however, the EPA is not finalizing an update requirement in this action. Monitoring agencies can assess their data and make decisions on an update based on whether they are meeting the bias MQOs. Such decisions on whether or not to update a method may efficiently be included in those agencies' annual monitoring network plans under 40 CFR 58.10, “Annual monitoring network plan and periodic assessment,” which are already subject to EPA Regional office approval. In some circumstances, it is possible the original PM FEM may be revised in a manner where only the updated method has an active approved designation. In these cases, monitoring agencies would need to address updating their PM FEM in a timely manner.
The EPA solicited input on any alternative approaches that could lead to more sites meeting the bias MQO with automated PM FEMs, especially for those sites that are near the level of the primary annual PM
The EPA received several comments on how to implement a local or regional calibration of FEMs. One commenter suggested that EPA could allow for SLT agencies to adjust FEM data to be more “FRM-like” prior to submitting data to AQS. Another commenter suggested using a rolling 3-month linear regression based on a comparison of FEM data to PM
Among the alternative approaches suggested, having settings that would allow for adjustments to make FEM data more “FRM-like” has merit, but assuming this was within a PM FEM itself, it would need to be separately incorporated into each make and model of FEM. If EPA were to pursue this alternative approach, the suggestion could be incorporated into a future regulatory action as a potential condition of designation because, without having the opportunity to thoughtfully consider how every step of such an approach would need to work, including what such requirements would look like and how potential settings adjustments would be made, it is not appropriate for the EPA to require the availability of such settings now, nor would it address the inventory of currently available PM FEMs already operating.
Regarding the suggestion that the EPA and SLTs should work with the manufacturers of FEM equipment to diagnose the cause of any biases and then to address them appropriately, the EPA supports this recommendation, but does not believe a regulatory change is required to allow the monitoring community (EPA and SLTs) to work with instrument manufacturers in this way.
Regarding the several comments on how to implement a local or regional calibration of FEMs, the EPA acknowledges the desire for this flexibility but believes that any such provisions for local or regional calibration of FEMs would need to be thoroughly thought out and proposed for consideration across the monitoring community. While several commenters support such an approach, the EPA also received adverse comments on the potential for local and regional calibration of PM FEMs instead of national. Most of the criticism of local and regional calibration of PM FEMs centered on both the lack of existing operating PM FRMs in commenters' networks and monitoring agencies' inability to staff the higher number of operating FRMs that would have to be collocated with PM FEMs to calibrate. Thus, the commenters that oppose local and regional calibrations of data prefer to utilize the national calibration of FEM data as proposed. Acknowledging all of these viewpoints, the EPA believes that it would not be appropriate to institute such an approach at this time. As discussed throughout this section, this final rule, the EPA is embarking on a new national approach to calibration of FEMs where valid State, local, and
In summary, the EPA is finalizing its proposal to allow valid State, local, and Tribal air monitoring data from PM FRMs and FEMs generated in routine networks and submitted to the EPA to update factory calibrations included as part of approved FEMs (40 CFR part 58, appendix C, sections 2.2 and 2.7). This approach, which will typically be initiated by instrument manufacturers but can also be spurred by monitoring agencies, MJOs of monitoring agencies, and the EPA itself, is to be implemented as a national solution in factory calibrations of approved FEMs through a firmware update, subject to EPA approval. FEM calibrations can apply to any PM FEM methods (
To enhance protection of air quality in communities subject to disproportionate air pollution risk, particularly in light of the proposed range for a revised primary annual PM
The PM
The EPA received comments concerning the proposed requirement to modify the PM
Overall, most commenters were very supportive of the EPA's proposed modification to the PM
Some commenters were generally supportive of the proposed requirement but suggested that the EPA should recast the approach in a more specific way or offered additional examples of sources of concern. For example, one commenter stated that PM
Among adverse comments, a few commenters stated that “at-risk communities” is not well defined. The EPA disagrees and directs those commenters to the numerous places where this definition is covered, including in Section II.B.2 of the proposal where we explained the term related to a variety of at-risk populations (88 FR 5591-92, January 27, 2023) as well as section 12.5 of the 2019 ISA (U.S. EPA, 2019a) and section 3.3.3 of the ISA Supplement (U.S. EPA, 2022a). Other commenters oppose the addition of the proposed monitoring because they feel it would reduce flexibility for agencies in deciding where they should site monitors, advocating that monitoring agencies should be afforded maximum flexibility to identify where to site monitors for at-risk areas. Because the EPA recognizes the challenges cited by these commenters related to establishing new ambient air monitoring stations, the EPA is finalizing the modified requirement on PM
A few commenters asked that the EPA require more monitoring than proposed. One commenter stated that it would be more beneficial to overburdened communities if air monitoring were required in all at-risk communities. A few commenters asked that EPA require additional monitoring for attainment of PM
However, the EPA also received substantial concerns from monitoring agencies about their resource constraints, including staffing to support any potential new monitoring. The EPA also notes that the existing and robust network of almost 1,000 PM
The EPA concludes that the requirements in this final rule for siting of monitoring in at-risk communities will meaningfully improve the PM
A few commenters asked that the EPA enhance monitoring in smaller cities and rural areas. One commenter asked for the EPA to extend the proposed monitoring network to Micropolitan Statistical Areas with populations of 10,000-50,000 and to rural areas. Another commenter pointed out that current air quality monitoring networks focus on urban and densely populated areas; therefore, rural areas are often not captured in this existing monitoring infrastructure, despite well-documented examples of high PM concentration in rural communities. The commenter believes this results in inadequate assessment of air pollution exposures for a substantial segment of the U.S. population. The EPA disagrees that there needs to be additional requirements for small CBSA's and rural areas. Regarding these comments, the EPA points out that we have a long-standing requirement for each State to monitor at background and transport sites (40 CFR part 58, appendix D, section 4.7.3—Requirement for PM
Some commenters disagree that the proposed revision to the PM
In the proposal, the EPA identified that, in light of the evidence of increased risk to at-risk communities, it would be appropriate to better characterize exposures for communities in proximity to local sources of concern (88 FR 5673-76, January 27, 2023). Thus, the EPA proposed that enhanced networks should include representation of at-risk communities living near emission sources of concern (
A few commenters suggested the inclusion of sources that are often considered line and/or area sources,
One commenter noted that the proposal may have unintentionally taken out the requirement related to specific design criteria for PM
To ensure minimally required monitoring sites appropriately represent exposures in at-risk communities, the EPA proposed that sites represent “area-wide” air quality near local sources of concern (88 FR 5674, January 27, 2023). Sites representing “area-wide” air quality are those monitors sited at neighborhood, urban, and regional scales, as well as those monitors sited at either micro- or middle-scale that are identified as being representative of many such locations in the same Metropolitan Statistical Area (MSA).
The EPA received a few comments on its proposed requirement that minimally required sites represent “area-wide” air quality. One commenter stated that the inclusion of a provision for EJ would narrow the location of monitors to certain communities that may not best represent “areawide” air quality. Another commenter asked the EPA to consider removing requirements that sites be area-wide, since 24-hour and annual averaging times would miss short, elevated pollution events. A couple commenters had concerns with the difference in the scale of representation between EJ monitors using small scale and other NAAQS monitors using area-wide scale, in that area-wide scale would not protect those most at risk. However, another commenter agreed with the EPA that sites representing at-risk communities should represent area-wide air quality. In addition to these comments, the EPA received many comments with support for its proposed modifications to the network design criteria as whole.
Regarding whether narrowing the location to certain communities may not best represent “area-wide” air quality, the EPA notes that sites are either identified as being area-wide or not; the EPA did not suggest it was seeking a best “area-wide” location. In response to the comment that area-wide site may miss short, elevated pollution events, the EPA is aware that there can be local, short-term spikes in PM
After considering all the comments on this topic, the EPA is finalizing this part of the modification to the network design criteria to maintain, consistent with our long-standing network design criteria, that all minimally required sites are to represent area-wide air quality.
In addition to using data from the robust network of almost 1,000 PM
In the proposal, the EPA identified that assessing and prioritizing at-risk communities for monitoring can be accomplished through several approaches (88 FR 5675). The most critical aspect of prioritizing which communities to monitor is their representation of the at-risk populations described earlier in this section. The other major consideration is whether the community is near a source or sources of concern. While many CBSAs have one or more sources of concern described above, some CBSAs will not have a quantity of emissions from sources of concern that result in an elevated level of measured PM
In its proposal, the EPA highlighted that tools such as the EPA's EJSCREEN
The EPA supports the use of other State and local tools designed to help identify the at-risk communities that
For at-risk communities, monitoring agencies need data that can best inform where there may be elevated levels of exposures from sources of concern. While we use FRMs and FEMs to determine compliance with the NAAQS, data from these methods will only be available at existing sites. However, there are several additional datasets available that may be useful in evaluating the potential for elevated levels of exposure to communities near sources of concern. In the proposal, EPA identified potential non-regulatory monitoring datasets such as CSN, IMPROVE, and AQI non-regulatory PM
In considering the datasets identified in the proposal as well as the ones commenters provided, the EPA believes all the datasets have value to help inform where there may be elevated levels of exposures from sources of concern. However, each of them may also have limitations and, therefore, users should be careful not to rely solely on one dataset versus another for all purposes. Fortunately, many of the available datasets are becoming easier to work with and more accessible, which will allow interested parties and monitoring agencies the opportunity to efficiently review the datasets and determine best applicability. For all of these reasons, the EPA is not finalizing a requirement to use a specific dataset or tool to identify at risk communities; however, whatever datasets a monitoring agency elects to use, its plan to use such data for purposes of meeting the network design requirements will be subject to EPA approval as part of the 40 CFR 58.10 annual monitoring network plan. Regarding the comment recommending shorter measurement intervals in measuring and reporting data to better understand exposure differences in disadvantaged communities, the EPA agrees and generally supports use of continuous methods. While we generally support use of continuous methods, approved filter-based technologies and methods also provide valuable air quality information. Therefore, the EPA is not requiring the use of automated continuous methods beyond what is already required in 40 CFR part 58, appendix D, section 4.7.2—Requirement for Continuous PM
The monitoring methods appropriate for use at required PM
The EPA requested comment on the measurement methods most useful to collocate with PM
The EPA appreciates the comments provided on the measurement methods most useful to collocate with PM
In the proposal, the EPA identified that, to meet the revised network design criteria, there will be only a few new sites required,
The EPA received a few comments on its proposed timeline for monitoring agencies to identify, propose, and ultimately bring any new or moved sites online. One commenter asked that the timeline give states more time to start or move sites. A few commenters asked that the EPA only require meeting a timeline for identifying whether any new or moved sites are needed after the EPA has provided the monitoring agencies with guidance on the priority of the potential at-risk communities. One of those commenters further requests that the EPA allow at least 24 months from the date of approval of a § 58.10 monitoring plan identifying any relocation of monitoring sites or establishment of new monitoring sites to implement any changes to the network, citing the need for more time to work with local officials, procure monitoring equipment, and contract for services, all of which can cause significant delays in establishing a monitoring site. Another commenter asked that the EPA remain attentive to the challenges that States, and air agencies face regarding recruiting and retaining the specialized staff needed to support their existing regulatory monitoring networks and the capital resources needed to implement and sustain new monitoring stations in areas that are clearly meeting the existing PM NAAQS or any revised PM NAAQS. Another commenter stated that the July 1, 2024, timeline for a network evaluation this complex is insufficient, noting that they submit their draft annual monitoring network plan for public review and comment in mid-April for 30 days. Because the final plan is due July 1 and must include all comments and responses and describe any changes based on those comments, the timeline does not take these requirements into consideration by allowing for the more extensive assessment of changes that may be needed to meet the proposed new monitoring requirements. The commenter stated that it would be appropriate to provide at least 12 months from the effective date of this final rule for monitoring agencies to initiate planning to implement these measures, seek input, consider revisions to their PM
As stated earlier, the EPA received strong support for our proposal to modify the PM
The EPA disagrees with the commenter that suggested the EPA should only require agencies to meet a timeline to identify whether any new or moved sites are needed after the EPA has provided the monitoring agencies with guidance on the priority of the potential at-risk communities, because the regulatory text provides all the guidance required for agencies to begin this process. As we explained above, the EPA does not anticipate that many new or moved sites will be required based on the final rule because we think most sites are already in suitable locations and long-term sites are highly valued. Also, monitoring agencies have discretion to provide to the EPA their recommendations regarding how they intend to meet the modifications to the PM
The EPA considered both the concerns and support for the timeline proposed and clarifies that the component of the proposed requirement regarding the need to identify potential new sites or an intention to move sites to be included in the annual monitoring network plan due to EPA on July 1, 2024, would be satisfied with a statement of intent to pursue a new site per the revised network design criteria and in consideration of the minimum monitoring requirements. While monitoring agencies may provide as much detail as they deem appropriate regarding the revised PM
In summary, the EPA is finalizing modifications to the PM
The EPA proposed changes to monitoring requirements in the Appendix E—Probe and Monitoring Path Siting Criteria for Ambient Air Quality Monitoring (88 FR 5676-78, January 27, 2023). Since 2006, the EPA finalized multiple rule revisions to establish siting requirements for PM
The EPA only received a few comments on the proposed rulemaking pertaining to the proposed changes regarding probe and monitoring path siting criteria for ambient air quality monitoring, most of which were supportive of the proposed revisions. One commenter noted that the image for Figure E-1 in Appendix E to part 58 was distorted and of extremely poor quality, rendering the text in places almost unreadable (88 FR 5712, January 27, 2023). The EPA makes several references to Figure E-1, which provides detailed information needed for assessing a range of acceptable probe distances from roadways based on a monitor's spatial scale. The commenter also stated that a higher quality image is needed for the figure so that agencies can fully interpret the figure to the extent that EPA requires. The EPA agrees with the commenter that a higher quality image for Figure E-1 is important and needed. Based on this comment, the EPA is finalizing the revision to Figure E-1 to clearly communicate the requirements of appendix E.
The EPA is revising appendix E in its entirety as proposed (88 FR 5709-5717, January 27, 2023) for clarity and as described in detail below.
The EPA proposed to relocate all open path monitor siting criteria requirements to a separate section in appendix E from those requirements for siting samplers and monitors that utilize probe inlets (88 FR 5676, January 27, 2023). Separate sections for these distinct monitoring method types allows the EPA to more clearly articulate minimum technical siting requirements for each.
The EPA received one supportive comment to adopt this change and received no adverse comments. Another commenter stated the regulatory text of the proposal improves the clarity of the appendix but encouraged the EPA to break the summary tables down further into more manageable components (perhaps by pollutant). The commenter stated that summary tables for the proposed appendix continue to be a “jumbled mess of regulatory requirements.” The EPA agrees that the summary tables E-3 and E-6 in the proposal could be improved further. Also, the EPA found that footnote 3 of Table E-6 in the proposed rule was incomplete and corrected this editorial error.
Therefore, the EPA is making editorial changes to both summary tables E-3 and E-6 and finalizing the remainder of the language as proposed with the open path monitor siting criteria requirements placed into a separate section of the appendix.
The EPA proposed to require that when rounding is performed to assess compliance with these siting requirements, the distance measurements will be rounded such as to retain at least two significant figures (88 FR 5676, January 27, 2023). The EPA proposed to communicate this rounding requirement in the regulatory text using footnotes in the tables of this appendix.
The EPA received two supportive comments and no adverse comments regarding this proposed change. While supportive of the proposal, one of the two supporting comments suggested it would be clearer if EPA explicitly defined a decimal in the distance values and round to the nearest tenths place for these assessments. The EPA disagrees with this recommendation because in some cases it would be more restrictive and burdensome than the proposed requirement that was intended to provide both clarity and flexibility. Therefore, the EPA is finalizing the language as proposed.
The EPA proposed to provide additional specificity and flexibility to the summary table for probe siting criteria by changing the “>” (greater than) symbols to “≥” (greater than or equal to) symbols in the summary table E-4 (88 FR 5676, January 27, 2023). Because one commenter pointed out to the EPA that in the prior version of the rule there was no table E-4, as a clerical matter, we have renumbered this summary table to table E-3 in the final rule. This proposed minor revision to the summary table more clearly expresses the EPA's intent that the distance offsets provided in the summary tables in appendix E are acceptable for NAAQS compliance monitoring.
The EPA received one comment supporting the proposal. The EPA received no adverse comments. Because
The EPA proposed to clarify and provide flexibility regarding siting monitors near minor sources by changing a requirement to a goal (88 FR 5676-77, January 27, 2023). To accomplish this, the EPA proposed to replace the “must” in the regulation with a “should.” While the EPA proposed to change this requirement to a goal, the EPA reiterated in the proposal that it recommends that sites with minor sources be avoided whenever practicable and probe inlets should be spaced as far from minor sources as possible when alternative monitoring stations are not suitable.
The EPA received one comment supporting the proposed revision and received no adverse comments. Therefore, the EPA is finalizing the language as proposed.
The EPA proposed to clarify and redefine that the minimum arc required to be free of obstructions for a probe inlet or monitoring path is 270-degrees and that probe inlets must be no closer than 10-meters to the driplines of any trees (88 FR 5677, January 27, 2023). These changes were proposed because of inconsistencies introduced into the rule with the 2006 rulemaking. Both are discussed in more detail in the following sections.
The majority of comments received were supportive of these proposed siting amendments and clarifications. Two commenters were not supportive of this proposal. One adverse comment focused on the potential that site modifications would be required if the minimum arc required to be free of obstructions for a probe inlet is 270-degrees. The second adverse comment pertained to the proposal to clarify distance requirements from tree driplines. The commenter stated they would expect significant challenges in meeting the proposed 20-meter tree dripline distance. This comment is not a substantive negative comment because the 20-meter distance provided in the proposal is a goal and not a requirement. As such, monitoring organizations should not expect additional challenges in meeting the probe siting requirements. One supportive commenter on the 270-degree minimum arc proposal also requested that the EPA acknowledge that some cases exist where monitoring is desired or necessary to protect the public health, but siting criteria cannot be met.
Based on the only two negative comments received from monitoring agencies or organizations, one of which was not substantive, the EPA believes most sites already meet these proposed requirements related to the arc and distance from dripline. However, the EPA also acknowledges that there may be limited cases where this proposed revision may require site modifications, and some sites may not be able to be achieve the proposed siting requirements, even with modifications to the site. For cases where long-term trend sites or monitors that determine the design value for their area cannot reasonably meet these regulatory siting requirements, the EPA encourages monitoring organizations to work with their respective EPA Regional offices to determine if a waiver from this siting criteria would be appropriate under appendix E, section 10.
These siting requirements are discussed in more detail below in sections VII.B.5.f and VII.B.5.h.
The EPA proposed to correct identified inconsistencies in the 270-degree requirement for unrestricted airflow to the probe inlet by reinstating the requirement stated in appendix E, paragraph 4(b), and to clarify that the continuous 180-degree minimum arc of unrestricted airflow provision is reserved for monitors sited on the side of a building or wall to comply with network design criteria requirements specified in appendix D of part 58 (88 FR 5677, January 27, 2023).
The EPA received two comments regarding this proposal, with one being supportive and one being negative. The adverse comment focused on the potential that site modifications would be required if this revision was made. The commenter supporting the proposal also requested that the EPA acknowledge that some cases exist where monitoring is desired or necessary to protect the public health, but siting criteria cannot be met. The EPA agrees with both commenters and acknowledges that there does exist limited cases where this proposal would require site modifications and some sites may not be able to be achieve the proposed siting requirement even with modifications to the site. For these cases, and especially when long-term trend sites or monitors that determine the design value for their area cannot reasonably meet these regulatory siting requirements, the EPA encourages monitoring organizations to work with their respective EPA Regional Offices to determine if a waiver from this siting criteria is appropriate through the provisions found in Section 10 of this appendix.
Based on the EPA only receiving a single negative comment regard the 270-degree and 180-degree provisions the EPA thinks most sites already meet these proposed requirements. Additionally, as stated above, the EPA is also retaining waiver provisions from these siting requirements for the remaining cases that can be exercised when appropriate. Therefore, the EPA is finalizing the language as proposed.
The EPA proposed to clarify the definitions of “obstructions” and “obstacles” in the regulatory text (88 FR 5677, January 27, 2023). Stating that, “[o]bstructions to the air flow of the probe inlet are those obstacles that are horizontally closer than twice the vertical distance the obstacle protrudes above the probe inlet and can be reasonably thought to scavenge reactive gases or to restrict the airflow for any pollutant,” the EPA proposed to reiterate that the EPA does not generally consider objects or obstacles such as flag poles or site towers used for NO
The EPA received one comment supporting the proposal and received no adverse comments. Therefore, the EPA is finalizing the definitions as proposed.
The EPA proposed to reconcile the conflicting requirements in 5(a) and the prior table E-4 footnote 3 by clarifying that the probe inlet must always be no closer than 10 meters to the tree dripline (88 FR 5677, January 27, 2023). The EPA also proposed to reinstate the goal “that monitor probe inlets should be at least 20-meters from the driplines of trees,” a goal that was inadvertently omitted during previous rule revisions. In addition, the EPA proposed to clarify that if a tree or group of trees is considered an “obstruction,” section 4(a) will apply.
As described above, the majority of comments received were supportive of the EPA proposed amendments and clarification, with two commenters focused on the possibility that monitoring agencies may not be able to meet the revised siting requirements. Specific to the proposed dripline requirement, the EPA reiterates that the
Another commenter recommended that the proposal should also include an elevation specification. For instance, if a monitor is on the roof of a shelter, a tree below that roof should not be considered an obstruction no matter the distance to the dripline. The EPA considers this scenario to occur in practice only rarely. The EPA agrees that when the overall tree height is less than the height of the probe inlet, the tree is not obstructing the airflow to the probe inlet. However, a tree in such proximity to the probe inlet in many cases is not likely to remain at a height lower than the probe inlet. The EPA considers a scenario such as this to be best addressed in the waiver provisions of this appendix due both to the rarity of this occurring as well as the need for the EPA to periodically reassess whether tree growth has adversely impacted the site conditions.
For these reasons, the EPA is finalizing the language as proposed.
The EPA proposed to require that microscale sites for any pollutant shall have no trees or shrubs blocking the line-of-sight fetch between the monitor's probe inlet and the source under investigation (88 FR 5677, January 27, 2023). This proposed revision would bring consistency between near-road monitoring stations and other microscale monitoring.
The EPA received one comment on this proposed requirement expressing concerns regarding its practicality and legality. The commenter stated agencies may at times want to site a monitor close to a source, but the closest location will have trees in the line of sight on private property. Additionally, in some cases, the trees may have been planted for the purpose of reducing off-property emissions from a source such as a Concentrated Animal Feeding Operation (CAFO). The commenter further stated that the proposal mandates that State agencies order the removal of trees from private property to collect valid data.
The EPA disagrees that the proposed requirement is impractical or unlawful. The proposed requirement would not require, mandate, or otherwise empower monitoring agencies to force the removal of trees on private property. The EPA agrees with the commenter that trees may at times be planted as part of control strategies to reduce offsite emissions and thus protect the public, but the EPA disagrees with the commenter that the trees must be removed to perform ambient air monitoring in these locations. Rather, if trees or shrubs block the line-of-sight fetch between the monitor's probe inlet and the source under investigation, it is the EPA's position that, for most cases, a microscale designation does not accurately reflect the monitoring scale for this location, and instead the EPA would recommend that the monitoring scale be designated to a more representative monitoring scale such as middle scale or neighborhood scale.
Moreover, for cases where long-term trend sites or monitors that determine the design value for an area cannot reasonably meet this regulatory siting requirement, the EPA encourages monitoring organizations to work with their respective EPA Regional offices to determine if a waiver from this siting criteria may be appropriate under appendix E, section 10.
For these reasons, the EPA is finalizing the language as proposed.
The EPA proposed to maintain the appendix E, section 10 waiver provisions in the current regulation for siting criteria, but to modify section 10.3 to require that waivers from the probe-siting criteria must be reevaluated and renewed minimally every 5 years (88 FR 5677-78, January 27, 2023).
The EPA received one comment supporting the proposal and no adverse comments. Therefore, the EPA is finalizing the language as proposed.
The EPA proposed to expand the list of acceptable probe materials for sampling reactive gases in appendix E, section 9, from just borosilicate glass and fluorinated ethylene propylene (FEP) Teflon®, or their equivalents. The EPA proposed to add polyvinylidene fluoride (PVDF), also known as Kynar®, polytetrafluoroethylene (PTFE), and perfluoroalkoxy (PFA) to the list of approved materials for efficiently transporting gaseous criteria pollutants, and the use of Nafion
The EPA received two comments supporting the proposal and received no adverse comments. Therefore, the EPA is finalizing the language as proposed.
In the proposal, the EPA requested comment on how to incorporate data from next generation technologies into Agency efforts (88 FR 5678-80, January 27, 2023). The near real-time integration of data from PM
The EPA received comments from about two dozen entities on its request for comments on how to incorporate data from next generation technologies. The entities that provided comment included federal agencies; representatives of industry and industry groups; public health, medical, and environmental organizations; State, local and related multi-state organizations involved in air program management; Tribes and Tribal organizations involved in air program management; and other State and local governments.
While there were some differences across commenters, a majority of the commenters support use of next generation data for non-regulatory purposes, but not for regulatory decision making due to their inherent uncertainties and limitations. The EPA also received comments from some environmental organizations support using alternative data for regulatory decision making.
Many commenters pointed out that they are already successfully using sensor data and networks in supplemental and informational applications and support further expansion of these capabilities. Across many commenters, there was support for using next generation data as “fit for purpose,” filling in gaps, finding hot spots, identifying and addressing EJ concerns, and evaluating and informing network siting. The EPA acknowledges the successful examples of sensor data and networks for non-regulatory purposes. A few commenters support expanding the use of sensor data to provide real-time AQI; the EPA is interested in this use of next generation data as well. A few commenters pointed the need for the EPA to work closely with them and their communities to understand and use next generation data, while others expressed a desire for help developing best practices around collecting and using next generation data, developing products with data analysis/visualization, and developing appropriate QA/QC for sensor data. The EPA acknowledges each of these requests and expects to continue to work closely with SLTs and other stakeholders to understand and develop information on the collection and use of next generation data.
A few commenters offered more detailed comments. Some recommended that the EPA repropose implementation provisions related to next generation technologies with greater clarity to provide for meaningful comment. For example, the use of low-cost sensor and satellite data could be used in drawing nonattainment area boundaries or identifying sources for emissions control, but doing so would be such a significant change from prior EPA policy that it warrants a more specific proposal, beyond the scope of this request for comment. In response to this comment, the EPA notes it did not propose or change the use of non-regulatory measurement data as part of this proposal, but instead opened an opportunity to comment about the use of next generation technologies.
Another commenter stated that while low-cost sensor data can be invaluable for some purposes, the potentially overwhelming amount of data produced by sensors may present additional challenges to communities without the resources or expertise to analyze it. Cost is another concern associated with some next generation technologies of which some communities may not be aware, as the initial cost of the sensor alone is not indicative of the total cost of operation, which can include costs of internet access and servers. The EPA appreciates the need to consider all the costs of implementing and maintaining sensor data.
Another commenter stated that having a dense sensor network collocated with FRMs and FEMs could help ensure timely maintenance of the regulatory measurements in the event there appears to be a divergence of data. The EPA appreciates the comment that emphasizes how sensors could be used to complement the FRM and FEM data with regard to ensuring timely maintenance.
Another commentor strongly opposes incorporating sensor data into any EPA systems unless robust quality assurance (QA) practices are widely established and managed by qualified personnel. The EPA agrees that QA is necessary, and notes that the “fit for purpose” aspect of using sensor data will inform the appropriate QA associated with the intended use of such data.
In summary, the EPA invited comment on how we should consider incorporating data from next generation technologies into our air monitoring efforts. In seeking comment on this topic, the EPA did not propose to add, edit, or delete any regulatory language associated with the PM NAAQS. The EPA received comments from a variety of entities that largely support using next generation data for a variety of purposes that supplement, but cannot replace, the measurement data from monitoring methods required (
The EPA's revision to the primary annual PM
The NPRM also referred to the PM
As discussed in section II, with respect to the PM
The timeline for initial area designations begins with promulgation of the revised primary annual PM
Section 107(d)(1) of the CAA states that, “By such date as the Administrator may reasonably require, but not later than 1 year after promulgation of a new or revised national ambient air quality standard for any pollutant under section
If the EPA agrees with the designations recommendation of the State, then it may proceed to promulgate the designations for such areas. If, however, the EPA disagrees with the State's recommendation, then the EPA may elect to make modifications to the recommended designations. By no later than 120 days prior to promulgating the final designations, the EPA is required to notify States of any intended modifications to the State designation recommendations for any areas or portions thereof, including the boundaries of areas, as the EPA may deem necessary. States then have an opportunity to comment on the EPA's intended modification and tentative designation decision. If a State elects not to provide designation recommendations for any area, then the EPA must itself promulgate the designation that it deems appropriate.
While section 107(d) of the CAA specifically addresses the designations process for States, the EPA intends to follow the same process for Tribes to the extent practicable, pursuant to section 301(d) of the CAA regarding Tribal authority, and the Tribal Authority Rule (63 FR 7254, February 12, 1998). To provide clarity and consistency in doing so, the EPA issued a guidance memorandum to our Regional Offices on working with Tribes during the designations process.
Consistent with the process used in previous area designations efforts, the EPA will evaluate each area on a case-by-case basis considering the specific facts and circumstances unique to the area to support area boundary decisions for the revised standard. The EPA intends to issue a designations memorandum which will provide information regarding the designations process. In broad overview, the EPA has historically used area-specific analyses to support nonattainment area boundary recommendations and final boundary determinations by evaluating factors such as air quality data, emissions and emissions-related data (
As with past revisions of the PM
Monitoring data are currently available from numerous existing PM
Consistent with past practice and as noted in the NPRM, the EPA intends to provide additional information concerning the designations process, including information about the schedule and recommendations for determining area boundaries in the forthcoming Annual PM
As discussed in the proposal, the “Treatment of Data Influenced by Exceptional Events; Final Rule,” (81 FR 68216, October 3, 2016) and codified at 40 CFR 50.1, 40 CFR 50.14, and 40 CFR 51.930, contains instructions and requirements for air agencies that may
The EPA has provided tools to assist air agencies in preparing adequate exceptional events demonstrations.
As discussed in the NPRM, the CAA directs States to address basic SIP requirements to implement, maintain, and enforce the NAAQS. Under CAA sections 110(a)(1) and (2), states are required to have State implementation plans that provide the necessary air quality management infrastructure that provides for the implementation, maintenance, and enforcement of the NAAQS. After the EPA promulgates a new or revised NAAQS, States are required to make a new SIP submission to establish that they meet the necessary structural requirements for such new or revised NAAQS or make changes to do so. The EPA refers to this type of SIP submission as an “infrastructure SIP submission.” Under CAA section 110(a)(1), all States are required to make these infrastructure SIP submissions within three years after the effective date of a new or revised primary standard. While the CAA authorizes the EPA to set a shorter time for States to make these SIP submissions, the EPA is requiring submission of infrastructure SIPs within three years of the effective date of this revised primary annual PM
The EPA has provided general guidance to States concerning its interpretation of these requirements of CAA section 110(a)(1) and (2) in the context of infrastructure SIP submissions for a new or revised NAAQS.
As a reminder, the EPA notes that States are not required to address nonattainment plan requirements for purposes of the revised primary annual PM
Accordingly, the EPA does not expect States to address the requirement for a new or revised NAAQS in the infrastructure SIP submissions to include regulations or emissions limits developed specifically for attaining the relevant standard in areas designated nonattainment for the revised primary annual PM
One of the required infrastructure SIP elements is that each State SIP must contain adequate provisions to prohibit, consistent with the provisions of title I of the CAA, emissions from within the State that will significantly contribute to nonattainment in, or interfere with maintenance by, any other State of the primary or secondary NAAQS.
Each State has the authority and responsibility to review its air quality management program's existing SIP provisions in light of a new or revised NAAQS to determine if any revisions are necessary to implement the new or revised NAAQS. Most States have revised and updated their SIPs in recent years to address requirements associated with other revised NAAQS. For certain infrastructure elements, some States may believe they already have adequate State regulations adopted and approved into the SIP to address a particular requirement with respect to the revised primary annual PM
If a State determines that existing SIP-approved provisions are adequate in light of this revised primary annual PM
Like any other SIP submission, that State can make such an infrastructure SIP submission certifying that it has already met some or all of the applicable requirements only after it has provided reasonable notice and opportunity for public hearing. This “reasonable notice and opportunity for public hearing” requirement for infrastructure SIP submissions is to meet the requirements of CAA sections 110(a) and 110(l). Under the EPA's regulations at 40 CFR part 51, if a public hearing is held, an infrastructure SIP submission must include a certification by the State that the public hearing was held in accordance with the EPA's procedural requirements for public hearings. See 40 CFR part 51, appendix V, section 2.1(g), and see 40 CFR 51.102.
In consultation with the EPA's Regional office, a State should follow all applicable EPA regulations governing infrastructure SIP submissions in 40 CFR part 51—
As discussed in the NPRM, the EPA issued a SIP Requirements Rule for implementing the PM
The PM
As stated in the NPRM, the PM
The PM
As previously mentioned, the PM
As summarized in sections III.B.4 and V.B.4 above, the EPA is retaining the current primary and secondary 24-hour PM
The CAA, at parts C and D of title I, contains preconstruction review and permitting programs applicable to new major stationary sources and major modifications of existing major sources. The preconstruction review of each new major stationary source and major modification applies on a pollutant-specific basis, and the requirements that apply for each pollutant depend on whether the area in which the source is situated is designated as attainment (or unclassifiable) or nonattainment for that pollutant. In areas designated attainment or unclassifiable for a pollutant, the Prevention of Significant Deterioration (PSD) requirements under part C apply to construction at major sources. In areas designated nonattainment for a pollutant, the Nonattainment New Source Review (NNSR) requirements under part D apply to construction at major sources. Collectively, those two sets of permit requirements are commonly referred to as the “major New Source Review” or “major NSR” programs.
Until the EPA designates an area with respect to the revised primary annual PM
Under the PSD program, the permit applicant must demonstrate that the new or modified source emissions increase does not cause or contribute to a NAAQS violation. In 2017, the EPA revised the
The statutory requirements for a PSD permit program set forth under part C of title I of the CAA (sections 160 through 169) are addressed by the EPA's PSD regulations found at 40 CFR 51.166 (minimum requirements for an approvable PSD SIP) and 40 CFR 52.21 (PSD permitting program for permits issued under the EPA's Federal permitting authority). These regulations already apply to PM
For PSD, a “major stationary source” is one with the potential to emit 250 tons per year (tpy) or more of any regulated NSR pollutant, unless the new or modified source is classified under a list of 28 source categories contained in the statutory definition of “major emitting facility” in section 169(1) of the CAA. For those 28 source categories, a “major stationary source” is one with the potential to emit 100 tpy or more of any regulated NSR pollutant. A “major modification” is a physical change or a change in the method of operation of an existing major stationary source that results, first, in a significant emissions increase of a regulated NSR pollutant and, second, in a significant net emissions increase of that pollutant. See 40 CFR 51.166(b)(2)(i), 40 CFR 52.21(b)(2)(i). The EPA PSD regulations define the term “regulated NSR pollutant” to include any pollutant for which a NAAQS has been promulgated and any pollutant identified by the EPA as a constituent or precursor to such pollutant. See 40 CFR 51.166(b)(49), 40 CFR 52.21(b)(50). These regulations identify SO
Upon the effective date of the revised primary annual PM
The EPA anticipates that the existing PM
In areas where air pollution exceeds the level of the revised primary annual PM
Part D of title I of the CAA includes preconstruction review and permitting requirements applicable to new major stationary sources and major modifications located in areas designated nonattainment for a pollutant for which the EPA has established a NAAQS (
For NNSR, “major stationary source” is generally defined as a source with the potential to emit at least 100 tpy of the regulated NSR pollutant for which the area is designated nonattainment. In some cases, however, the CAA and the NNSR regulations define “major stationary source” for NNSR in terms of a lower rate dependent on the pollutant and degree of nonattainment in the area. For purposes of the PM
Under the NNSR program, direct PM
For modifications, NNSR applies to proposed physical changes or changes in the method of operation of an existing stationary source where (1) the source is major for the nonattainment pollutant (or a precursor for that pollutant) and (2) the physical change or change in the method of operation of a major stationary source results, first, in a significant emissions increase of a regulated NSR pollutant and, second, in a significant net emissions increase of that same nonattainment pollutant (or same precursor for that pollutant).
New major stationary sources and major modifications for PM
Following the promulgation of this revised primary annual PM
Finally, the EPA has released several documents that discuss air permitting
Transportation conformity is required under CAA section 176(c) to ensure that transportation plans, transportation improvement programs (TIPs) and federally supported highway and transit projects will not cause or contribute to any new air quality violation, increase the frequency or severity of any existing violation, or delay timely attainment or any required interim emissions reductions or other milestones. Transportation conformity applies to areas that are designated as nonattainment or nonattainment areas that have been redesignated to attainment with an approved CAA section 175A maintenance plan (
The conformity requirement under CAA section 176(c) ensures that federal activities implemented by federal agencies will not interfere with a State's ability to attain and maintain the NAAQS. Under CAA 176(c)(1), the requirement prohibits Federal agencies from approving, permitting, licensing, or funding activities that do not conform to the purpose of the applicable SIP for the control and prevention of air pollution.
The general conformity program
With regard to issues regarding prescribed fires, which were addressed earlier in this action, here is some additional information regarding prescribed fires and General Conformity regulations. Under the General Conformity regulations at 40 CFR 93.153(c)(4), a conformity evaluation is not required to support a decision by a federal agency to conduct or carry out prescribed burning when the burn is consistent with the terms of a land management plan or other plan that includes the prescribed burn at issue, where the overall plan that includes the burn was previously evaluated under 40 CFR part 93 subpart B by the responsible federal agency, and the agency found the plan conforms under CAA paragraphs 176(c)(1)(A) and (1)(B). This assumes the burn at issue will be conducted by meeting any conditions specified as necessary for meeting conformity in the agency's decision to approve the plan. Alternatively, a presumption of conformity applies also under 40 CFR 93.153(i)(2) for prescribed fires conducted in accordance with a Smoke Management Program that meets the requirements of the EPA's 1998 Interim Air Quality Policy on Wildland and Prescribed Fires or an equivalent replacement EPA policy. The preamble to the Exceptional Events Rule explains that the EPA adapted language associated with the six basic components of a certifiable Smoke Management Program for exceptional events purposes from the 1998 Interim Air Quality Policy on Wildland and Prescribed Fires (
No changes are being made to the general conformity regulations in this final rulemaking and the EPA notes that the courts recognize the regulations constitute control for the established PM
Additional information about these statutes and Executive orders can be
This action is “significant regulatory action” as defined under section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, the EPA submitted this action to the Office of Management and Budget (OMB) for review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. The EPA prepared an illustrative analysis of the potential costs and benefits associated with this action. This analysis, “Regulatory Impact Analysis for the Reconsideration of the National Ambient Air Quality Standards for Particulate Matter,” is available in the Regulatory Impact Analysis (RIA) docket (EPA-HQ-OAR-2019-0587) and briefly summarized below. However, the CAA and judicial decisions make clear that the economic and technical feasibility of attaining ambient standards are not to be considered in setting or revising NAAQS, although such factors may be considered in the development of State plans to implement the standards. Accordingly, although an RIA has been prepared, the results of the RIA have not been considered in issuing this final rule.
The RIA estimates the costs and monetized human health benefits in 2032, after implementing existing and expected regulations and assessing emissions reductions to meet the current primary annual and 24-hour particulate matter NAAQS (12/35 μg/m
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0084. The data collected through this information collection consist of ambient air concentration measurements for the seven air pollutants with national ambient air quality standards (
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. Rather, this final rule establishes national standards for allowable concentrations of PM in ambient air as required by section 109 of the CAA. See also
This action does not contain an unfunded mandate of $100 million or more as described in the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Furthermore, as indicated previously, in setting a NAAQS the EPA cannot consider the economic or technological feasibility of attaining ambient air quality standards, although such factors may be considered to a degree in the development of State plans to implement the standards. See also
This action 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. However, the EPA recognizes that States will have a substantial interest in this action and any future revisions to associated requirements.
This action does not have Tribal implications, as specified in Executive Order 13175. It does not have a substantial direct effect on one or more Indian Tribes as Tribes are not obligated to adopt or implement any NAAQS. In addition, Tribes are not obligated to conduct ambient monitoring for PM or to adopt the ambient monitoring requirements of 40 CFR part 58. Thus, Executive Order 13175 does not apply to this action. However, consistent with the
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 subject to Executive Order 13045 because it is a significant regulatory action under section 3(f)(1) of Executive Order 12866, and the EPA believes that the environmental health or safety risk addressed by this action may have a disproportionate effect on children. Accordingly, we have evaluated the environmental health or safety effects of PM exposures on children. The protection offered by these standards may be especially important for children because childhood represents a lifestage associated with increased susceptibility to PM-related health effects. Because children have been identified as a susceptible population, we have carefully evaluated the environmental health effects of exposure to PM pollution among children. Children make up a substantial fraction of the U.S. population, and often have unique factors that contribute to their increased risk of experiencing a health effect due to exposures to ambient air pollutants because of their continuous growth and development. As described in the 2019 Integrated Science Assessment, children may be particularly at risk for health effects related to ambient air PM
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. The purpose of this action is to revise level of the primary annual PM
This rulemaking involved environmental monitoring or measurement. The EPA has decided it will continue to use the existing indicators for fine (PM
To the extent feasible, the EPA employs a Performance-Based Measurement System (PBMS), which does not require the use of specific, prescribed analytic methods. The PBMS is defined as a set of processes wherein the data quality needs, mandates or limitations of a program or project are specified and serve as criteria for selecting appropriate methods to meet those needs in a cost-effective manner.
The EPA believes that the human health or environmental conditions associated with the primary PM
Socioeconomic status (SES) is a composite measure that includes metrics such as income, occupation, or education, and can play a role in access to healthy environments as well as access to healthcare. SES may be a factor that contributes to differential risk from PM
The EPA believes that this action is likely to reduce existing disproportionate and adverse effects on communities with environmental justice concerns.
The EPA additionally identified and addressed environmental justice concerns by providing opportunities for public input on the proposed decisions. The EPA held a multi-day virtual public hearing for the public to provide oral testimony and there was a 60-day public comment period for the proposed action. As described in section II.A.3 above, the EPA conducted a risk assessment to support this action that included an at-risk analysis that evaluates exposure and PM
The information supporting this Executive Order review is is contained in sections II.A.2, II.B.3.a, II.B.3.c, II.B.2, and II.B.4. of this preamble and also in the 2019 Integrated Science Assessment, Supplement to the 2019 Integrated Science Assessment, and 2022 Policy Assessment. The EPA has carefully evaluated the potential impacts on minority populations and low SES populations as discussed in sections II.A.2, II.A.3, II.B.2, and II.B.4 of this preamble. The 2019 Integrated Science Assessment, Supplement to the Integrated Science Assessment, and 2022 Policy Assessment contain the evaluation of the scientific evidence, quantitative risk analyses and policy considerations that pertain to these populations. These documents are available in the public docket for this action.
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 meets the criteria set forth in 5 U.S.C. 804(2).
Environmental protection, Air pollution control, Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, chapter I of title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401,
(a) The national primary ambient air quality standards for PM
(1) A reference method based on appendix L to this part and designated in accordance with part 53 of this chapter; or
(2) An equivalent method designated in accordance with part 53 of this chapter.
(b) The primary annual PM
(c) The primary 24-hour PM
The revision and additions read as follows:
(b) The terms used in this appendix are defined as follows:
(d) 24-hour average concentrations will be computed from submitted hourly PM
(a) All computations shown in this appendix shall be implemented on a site-level basis. Site level concentration data shall be processed as follows:
(1) The default dataset for PM
(2) If a daily value is not produced by the primary monitor for a particular day, but a value is available from a single collocated monitor, then that collocated monitor value shall be considered part of the combined site data record. If daily value data is available from two or more collocated monitors, the average of those collocated values shall be used as the daily value. The data record resulting from this procedure is referred to as the “combined site data record.”
(b) In certain circumstances, including but not limited to site closures or relocations, data from two nearby sites may be combined into a single site data record for the purpose of calculating a valid design value. The appropriate Regional Administrator may approve such combinations if the Regional Administrator determines that the measured concentrations do not differ substantially between the two sites, taking into consideration factors such as distance between sites, spatial and temporal patterns in air quality, local emissions and meteorology, jurisdictional boundaries, and terrain features.
7.3.4
7.3.4.5 A second cyclone-type separator is identified as a Tisch TE-PM
The addition and revisions read as follows.
(a) This appendix explains the data handling conventions and computations necessary for determining when the national ambient air quality standards (NAAQS) for PM
(d) * * *
(3) In certain circumstances, including but not limited to site closures or relocations, data from two nearby sites may be combined into a single site data record for the purpose of calculating a valid design value. The appropriate Regional Administrator may approve such site combinations if the Regional Administrator determines that the measured concentrations do not differ substantially between the two sites, taking into consideration factors such as distance between sites, spatial and temporal patterns in air quality, local emissions and meteorology, jurisdictional boundaries, and terrain features.
(a) Levels of the primary and secondary annual PM
(a) Levels of the primary and secondary 24-hour PM
Sec. 301(a) of the Clean Air Act (42 U.S.C. 1857g(a)), as amended by sec. 15(c)(2) of Pub. L. 91-604, 84 Stat. 1713, unless otherwise noted.
The revisions and addition read as follows:
(a) Applications for FRM or FEM determinations and modification requests of existing designated instruments shall be submitted to: U.S. Environmental Protection Agency, Director, Center for Environmental Measurement and Modeling, Reference and Equivalent Methods Designation Program (MD-D205-03), 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711 (commercial delivery address: 4930 Old Page Road, Durham, North Carolina 27703).
(b) * * *
(7) All written materials for new FRM and FEM applications and modification requests must be submitted in English in MS Word format. For any calibration certificates originally written in a non-English language, the original non-English version of the certificate must be submitted to EPA along with a version of the certificate translated to English. All laboratory and field data associated with new FRM and FEM applications and modification requests must be submitted in MS Excel format. All worksheets in MS Excel must be unprotected to enable full inspection as part of the application review process.
(d) For candidate reference or equivalent methods or for designated instruments that are the subject of a modification request, the applicant, if requested by EPA, shall provide to EPA a representative sampler or analyzer for test purposes. The sampler or analyzer shall be shipped free on board (FOB) destination to Director, Center for Environmental Measurements and Modeling, Reference and Equivalent Methods Designation Program (MD D205-03), U.S. Environmental Protection Agency, 4930 Old Page Road, Durham, North Carolina 27703, scheduled to arrive concurrently with or within 30 days of the arrival of the other application materials. This sampler or analyzer may be subjected to various tests that EPA determines to be necessary or appropriate under § 53.5(f), and such tests may include special tests not described in this part. If the instrument submitted under this paragraph (d) malfunctions, becomes inoperative, or fails to perform as represented in the application before the necessary EPA testing is completed, the applicant shall be afforded the opportunity to repair or replace the device at no cost to the EPA. Upon completion of EPA testing, the sampler or analyzer submitted under this paragraph (d) shall be repacked by EPA for return shipment to the applicant, using the same packing materials used for shipping the instrument to EPA unless alternative packing is provided by the applicant. Arrangements for, and the cost of, return shipment shall be the responsibility of the applicant. The EPA does not warrant or assume any liability for the condition of the sampler or analyzer upon return to the applicant.
(a) A candidate method determined by the Administrator to satisfy the applicable requirements of this part shall be designated as an FRM or FEM (as applicable) by and upon publication of the designation in the
(c) * * *
(4) Send notice to the applicant that additional information must be submitted before a determination can be made and specify the additional information that is needed (in such cases, the 90-day period shall commence upon receipt of the additional information).
(5) Send notice to the applicant that additional tests are necessary and specify which tests are necessary and how they shall be interpreted (in such cases, the 90-day period shall commence upon receipt of the additional test data).
(6) Send notice to the applicant that additional tests will be conducted by the Administrator and specify the reasons for and the nature of the additional tests (in such cases, the 90-day period shall commence 1 calendar day after the additional tests are completed).
(b) * * *
(1) * * *
(ii) * * *
(D) Site D shall be in a large city east of the Mississippi River, having characteristically high humidity levels.
(a) * * *
(2) * * *
(xvi) * * *
(c) * * *
(2) * * *
(iv) * * *
if C
if C
(d) * * *
(2)
(g)
(1)
(i) The physical diameter of a generated spherical particle can be calculated from the operational parameters of the VOAG and FMAG as:
(2) * * *
(i) Solid particle tests performed in this subpart shall be conducted using particles composed of ammonium fluorescein. For use in the VOAG or FMAG, liquid solutions of known volumetric concentration can be prepared by diluting fluorescein powder (C
(iii) Calculation of the physical diameter of the particles produced by the VOAG and FMAG requires
42 U.S.C. 7403, 7405, 7410, 7414, 7601, 7611, 7614, and 7619.
The revision reads as follows:
The revisions and addition read as follows:
(a)(1) Beginning July 1, 2007, the State, or where applicable local, agency shall submit to the Regional Administrator an annual monitoring network plan which shall provide for the documentation of the establishment and maintenance of an air quality surveillance system that consists of a network of SLAMS monitoring stations that can include FRM and FEM monitors that are part of SLAMS, NCore, CSN, PAMS, and SPM stations. The plan shall include a statement of whether the operation of each monitor meets the requirements of appendices A, B, C, D, and E to this part, where applicable. The Regional Administrator may require additional information in support of this statement. The annual monitoring network plan must be made available for public inspection and comment for at least 30 days prior to submission to the EPA and the submitted plan shall include and address, as appropriate, any received comments.
(b) * * *
(10) Any monitors for which a waiver has been requested or granted by the EPA Regional Administrator as allowed for under appendix D or appendix E to this part. For those monitors where a waiver has been approved, the annual monitoring network plan shall include the date the waiver was approved.
(13) The identification of any PM
(14) The identification of any site(s) intended to address being sited in an at-risk community where there are anticipated effects from sources in the area as required in section 4.7.1(b)(3) of appendix D to this part. An initial approach to the question of whether any new or moved sites are needed and to identify the communities in which they intend to add monitoring for meeting the requirement in this paragraph (b)(14), if applicable, shall be submitted in accordance with the requirements of section 4.7.1(b)(3) of appendix D to this part, which includes submission to the EPA Regional Administrator no later than July 1, 2024. Specifics on the resulting proposed new or moved sites for PM
(d) The State, or where applicable local, agency shall perform and submit to the EPA Regional Administrator an assessment of the air quality surveillance system every 5 years to determine, at a minimum, if the network meets the monitoring objectives defined in appendix D to this part, whether new sites are needed, whether existing sites are no longer needed and can be terminated, and whether new technologies are appropriate for incorporation into the ambient air monitoring network. The network assessment must consider the ability of existing and proposed sites to support air quality characterization for areas with relatively high populations of
(a) * * *
(2) Beginning January 1, 2009, State and local governments shall follow the quality assurance criteria contained in appendix A to this part that apply to SPM sites when operating any SPM site which uses an FRM or an FEM and meets the requirements of appendix E to this part, unless the Regional Administrator approves an alternative to the requirements of appendix A with respect to such SPM sites because meeting those requirements would be physically and/or financially impractical due to physical conditions at the monitoring site and the requirements are not essential to achieving the intended data objectives of the SPM site. Alternatives to the requirements of appendix A may be approved for an SPM site as part of the approval of the annual monitoring plan, or separately.
(e) State and local governments must assess data from Class III PM
(1) The acceptable concentration range (Rj), µg/m
(2) The minimum number of test sites shall be at least one; however, the number of test sites will generally include all locations within an agency's network with collocated FRMs and FEMs.
(3) The minimum number of methods shall include at least one FRM and at least one FEM.
(4) Since multiple FRMs and FEMs may not be present at each site, the precision statistic requirement does not apply, even if precision data are available.
(5) All seasons must be covered with no more than 36 consecutive months of data in total aggregated together.
(6) The key statistical metric to include in an assessment is the bias (both additive and multiplicative) of the PM
(d) * * *
(1)(i) Manual PM
(ii) For SLAMS PM
(iii) Required SLAMS stations whose measurements determine the 24-hour design value for their area and whose data are within plus or minus 5 percent of the level of the 24-hour PM
(iv) Changes in sampling frequency attributable to changes in design values shall be implemented no later than January 1 of the calendar year following the certification of such data as described in § 58.15.
(a) The State, or where appropriate local, agency shall submit to the EPA Regional Administrator an annual air monitoring data certification letter to certify data collected by FRM and FEM monitors at SLAMS and SPM sites that meet criteria in appendix A to this part from January 1 to December 31 of the previous year. The head official in each monitoring agency, or his or her designee, shall certify that the previous year of ambient concentration and quality assurance data are completely submitted to AQS and that the ambient concentration data are accurate to the best of her or his knowledge, taking into consideration the quality assurance findings. The annual data certification letter is due by May 1 of each year.
(b) Along with each certification letter, the State shall submit to the Regional Administrator an annual
(c) Along with each certification letter, the State shall submit to the Regional Administrator a summary of the precision and accuracy data for all ambient air quality data collected by FRM and FEM monitors at SLAMS and SPM sites. The summary of precision and accuracy shall be submitted for data collected from January 1 to December 31 of the previous year.
(b) Any SPM data collected by an air monitoring agency using a Federal reference method (FRM) or Federal equivalent method (FEM) must meet the requirements of §§ 58.11 and 58.12 and appendix A to this part or an approved alternative to appendix A. Compliance with appendix E to this part is optional but encouraged except when the monitoring agency's data objectives are inconsistent with the requirements in appendix E. Data collected at an SPM using a FRM or FEM meeting the requirements of appendix A must be submitted to AQS according to the requirements of § 58.16. Data collected by other SPMs may be submitted. The monitoring agency must also submit to AQS an indication of whether each SPM reporting data to AQS monitor meets the requirements of appendices A and E.
(c) All data from an SPM using an FRM or FEM which has operated for more than 24 months are eligible for comparison to the relevant NAAQS, subject to the conditions of §§ 58.11(e) and 58.30, unless the air monitoring agency demonstrates that the data came from a particular period during which the requirements of appendix A, appendix C, or appendix E to this part were not met, subject to review and EPA Regional Office approval as part of the annual monitoring network plan described in § 58.10.
(d) If an SPM using an FRM or FEM is discontinued within 24 months of start-up, the Administrator will not base a NAAQS violation determination for the PM
(e) If an SPM using an FRM or FEM is discontinued within 24 months of start-up, the Administrator will not designate an area as nonattainment for the CO, SO
The revisions and additions read as follows:
2.6.1 Gaseous pollutant concentration standards (permeation devices or cylinders of compressed gas) used to obtain test concentrations for CO, SO
2.6.1.1 The concentrations of EPA Protocol Gas standards used for ambient air monitoring must be certified with a 95-percent confidence interval to have an analytical uncertainty of no more than ±2.0 percent (inclusive) of the certified concentration (tag value) of the gas mixture. The uncertainty must be calculated in accordance with the statistical procedures defined in Reference 4 of this appendix.
2.6.1.2 Specialty gas producers advertising certification with the procedures provided in Reference 4 of this appendix and distributing gases as “EPA Protocol Gas” for ambient air monitoring purposes must adhere to the regulatory requirements specified in 40 CFR 75.21(g) or not use “EPA” in any form of advertising. Monitoring organizations must provide information to the EPA on the specialty gas producers they use on an annual basis. PQAOs, when requested by the EPA, must participate in the EPA Ambient Air Protocol Gas Verification Program at least once every 5 years by sending a new unused standard to a designated verification laboratory.
3.1.3.3 Using audit gases that are verified against the NIST standard reference methods or special review procedures and validated per the certification periods specified in Reference 4 of this appendix (EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards) for CO, SO
3.2.4
4.2.1
Where
Where
4.2.5
The revisions and additions read as follows:
2.6.1 Gaseous pollutant concentration standards (permeation devices or cylinders of compressed gas) used to obtain test concentrations for CO, SO
2.6.1.1 The concentrations of EPA Protocol Gas standards used for ambient air monitoring must be certified with a 95-percent confidence interval to have an analytical uncertainty of no more than ±2.0 percent (inclusive) of the certified concentration (tag value) of the gas mixture. The uncertainty must be calculated in accordance with the statistical procedures defined in Reference 4 of this appendix.
2.6.1.2 Specialty gas producers advertising certification with the procedures provided in Reference 4 of this appendix and distributing gases as “EPA Protocol Gas” for ambient air monitoring purposes must adhere to the regulatory requirements specified in 40 CFR 75.21(g) or not use “EPA” in any form of advertising. The PSD PQAOs must provide information to the PSD reviewing authority on the specialty gas producers they use (or will use) for the duration of the PSD monitoring project. This information can be provided in the QAPP or monitoring plan but must be updated if there is a change in the specialty gas producers used.
3.1.3.3 Using audit gases that are verified against the NIST standard reference methods or special review procedures and validated per the certification periods specified in Reference 4 of this appendix (EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards) for CO, SO
3.2.4
3.2.4.1 Have each method designation evaluated each year; and,
3.2.4.2 Have all FRM and FEM samplers subject to a PEP audit at least once every 6 years, which equates to approximately 15 percent of the monitoring sites audited each year.
3.2.4.3 Additional information concerning the PEP is contained in Reference 10 of this appendix. The calculations for evaluating bias between the primary monitor and the performance evaluation monitor for PM
4.2.1
Where
Where
4.2.5
The additions and revision reads as follows:
2.2 PM
2.2.1 Data to demonstrate a calibration may include valid data from State, local, or Tribal air agencies or data collected by instrument manufacturers in accordance with 40 CFR 53.35 or other data approved by the Administrator.
2.2.2 A request to update a designated methods calibration may be initiated by the instrument manufacturer of record or the EPA Administrator. State, local, Tribal, and multijusistincional organizations of these entities may work with an instrument manufacture to update a designated method calibration.
2.2.3 Requests for approval of an updated PM
2.2.4 Data included in the request should represent a subset of representative locations where the method is operational. For cases with a small number of collocated FRMs and continuous FEMs sites, an updated candidate calibration may be limited to the sites where both methods are in use.
2.2.5 Data included in a candidate method updated calibration may include a subset of sites where there is a large grouping of sites in one part of the country such that the updated calibration would be representative of the country as a whole.
2.2.6 Improvements should be national in scope and ideally implemented through a firmware change.
2.2.7 The goal of a change to a methods calibration is to increase the number of sites meeting measurements quality objectives of the method as identified in section 2.3.1.1 of appendix A to this part.
2.2.8 For meeting measurement quality objectives (MQOs), the primary objective is to meet the bias goal as this statistic will likely have the most influence on improving the resultant data collected.
2.2.9 Precision data are to be included, but so long as precision data are at least as good as existing network data or meet the MQO referenced in section 2.2.8 of this appendix, no further work is necessary with precision.
2.2.10 Data available to use may include routine primary and collocated data.
2.2.11 Audit data may be useful to confirm the performance of a candidate updated calibration but should not be used as the basis of the calibration to keep the independence of the audit data.
2.2.12 Data utilized as the basis of the updated calibration may be obtained by accessing EPA's AQS database or future analogous EPA database.
2.2.13 Years of data to use in a candidate method calibration should include two recent years where we are past the certification period for the previous year's data, which is May 1 of each year.
2.2.14 Data from additional years is to be used to test an updated calibration such that the calibration is independent of the test years of interest. Data from these additional years need to minimally demonstrate that a larger number of sites are expected to meet bias MQO especially at sites near the level of the NAAQS for the PM indicator of interest.
2.2.15 Outliers may be excluded using routine outlier tests.
2.2.16 The range of data used in a calibration may include all data available or alternatively use data in the range from the lowest measured data available up to 125% of the 24-hour NAAQS for the PM indicator of interest.
2.2.17 Other improvements to a PM continuous method may be included as part of a recommended update so long as appropriate testing is conducted with input from EPA's Office of Research and Development (ORD) Reference and Equivalent (R&E) Methods Designation program.
2.2.18 EPA encourages early communication by instrument manufacturers considering an update to a PM method. Instrument companies should initiate such dialogue by contacting EPA's ORD R&E Methods Designation program. The contact information for this can be found at 40 CFR 53.4.
2.2.19 Manufacturers interested in improving instrument's performance through an updated factory calibration must submit a written modification request to EPA with supporting rationale. Because the testing requirements and acceptance criteria of any field and/or lab tests can depend upon the nature and extent of the intended modification, applicants should contact EPA's R&E Methods Designation program for guidance prior to development of the modification request.
2.7.1 Requests for approval under sections 2.2, 2.4, 2.6.2, or 2.8 of this appendix must be submitted to: Director, Center for Environmental Measurement and Modeling, Reference and Equivalent Methods Designation Program (MD-D205-03), U.S. Environmental Protection Agency, P.O. Box 12055, Research Triangle Park, North Carolina 27711.
The purpose of this appendix is to describe monitoring objectives and general criteria to be applied in establishing the required SLAMS ambient air quality monitoring stations and for choosing general locations for additional monitoring sites. This appendix also describes specific requirements for the number and location of FRM and FEM sites for specific pollutants, NCore multipollutant sites, PM
1.1 * * *
(b) Support compliance with ambient air quality standards and emissions strategy development. Data from FRM and FEM monitors for NAAQS pollutants will be used for comparing an area's air pollution levels against the NAAQS. Data from monitors of various types can be used in the development of attainment and maintenance plans. SLAMS, and especially NCore station data, will be used to evaluate the regional air quality models used in developing emission strategies, and to track trends in air pollution abatement control measures' impact on improving air quality. In monitoring locations near major air pollution sources, source-oriented monitoring data can provide insight into how well industrial sources are controlling their pollutant emissions.
4.7.1 * * *
(a) State and where applicable, local, agencies must operate the minimum number of required PM
(b) * * *
(3) For areas with additional required SLAMS, a monitoring station is to be sited in an at-risk community with poor air quality, particularly where there are anticipated effects from sources in the area (
4.7.2 Requirement for Continuous PM
(a) This appendix contains specific location criteria applicable to ambient air quality monitoring probes, inlets, and optical paths of SLAMS, NCore, PAMS, and other monitor types whose data are intended to be used to determine compliance with the NAAQS. These specific location criteria are relevant after the general location has been selected based on the monitoring objectives and spatial scale of representation discussed in appendix D to this part. Monitor probe material and sample residence time requirements are also included in this appendix. Adherence to these siting criteria is necessary to ensure the uniform collection of compatible and comparable air quality data.
(b) The probe and monitoring path siting criteria discussed in this appendix must be followed to the maximum extent possible. It is recognized that there may be situations where some deviation from the siting criteria may be necessary. In any such case, the reasons must be thoroughly documented in a written request for a waiver that describes whether the resulting monitoring data will be representative of the monitoring area and how and why the proposed or existing siting must deviate from the criteria. This documentation should help to avoid later questions about the validity of the resulting monitoring data. Conditions under which the EPA would consider an application for waiver from these siting criteria are discussed in section 4 of this appendix.
(c) The pollutant-specific probe and monitoring path siting criteria generally apply to all spatial scales except where noted otherwise. Specific siting criteria that are phrased with “shall” or “must” are defined as requirements and exceptions must be granted through the waiver provisions. However, siting criteria that are phrased with “should” are defined as goals to meet for consistency but are not requirements.
(a) For O
(b) Middle scale CO and NO
(c) Middle scale PM
(d) Microscale Pb, PM
(e) Microscale near-road NO
(f) The probe inlets for microscale carbon monoxide monitors that are being used to
(a) It is important to understand the monitoring objective for a particular site in order to interpret this requirement. Local minor sources of a primary pollutant, such as SO
(b) Similarly, local sources of nitric oxide (NO) and ozone-reactive hydrocarbons can have a scavenging effect causing unrepresentatively low concentrations of O
(a) Obstacles may scavenge SO
(b) A probe inlet located near or along a vertical wall is undesirable because air moving along the wall may be subject to removal mechanisms. A probe inlet must have unrestricted airflow with no obstructions (as defined in paragraph (a) of this section) in a continuous arc of at least 270 degrees. An unobstructed continuous arc of 180 degrees is allowable when the applicable network design criteria specified in appendix D of this part require monitoring in street canyons and the probe is located on the side of a building. This arc must include the predominant wind direction for the season of greatest pollutant concentration potential. For particle sampling, there must be a minimum of 2.0 meters of horizontal separation from walls, parapets, and structures for rooftop site placement.
(c) A sampling station with a probe inlet located closer to an obstacle than required by the criteria in this section should be classified as middle scale or microscale, rather than neighborhood or urban scale, since the measurements from such a station would more closely represent these smaller scales.
(d) For near-road monitoring stations, the monitor probe shall have an unobstructed air flow, where no obstacles exist at or above the height of the monitor probe, between the monitor probe and the outside nearest edge of the traffic lanes of the target road segment.
(a) Trees can provide surfaces for SO
(b) The scavenging effect of trees is greater for O
(c) Beginning January 1, 2024, microscale sites of any air pollutant shall have no trees or shrubs located at or above the line-of-sight fetch between the probe and the source under investigation,
In siting an O
(a) Near-road microscale CO monitoring sites, including those located in downtown areas, urban street canyons, and other near-road locations such as those adjacent to highly trafficked roads, are intended to provide a measurement of the influence of the immediate source on the pollution exposure on the adjacent area.
(b) Microscale CO monitor probe inlets in downtown areas or urban street canyon locations shall be located a minimum distance of 2.0 meters and a maximum distance of 10 meters from the edge of the nearest traffic lane.
(c) Microscale CO monitor probe inlets in downtown areas or urban street canyon locations shall be located at least 10 meters from an intersection, preferably at a midblock location. Midblock locations are preferable to intersection locations because intersections represent a much smaller portion of downtown space than do the streets between
(d) Neighborhood scale CO monitor probe inlets in downtown areas or urban street canyon locations shall be located according to the requirements in Table E-2 of this appendix.
(a) Since emissions associated with the operation of motor vehicles contribute to urban area particulate matter ambient levels, spacing from roadway criteria are necessary for ensuring national consistency in PM sampler siting.
(b) The intent is to locate localized hot-spot sites in areas of highest concentrations, whether it be caused by mobile or multiple stationary sources. If the area is primarily affected by mobile sources and the maximum concentration area(s) is judged to be a traffic corridor or street canyon location, then the monitors should be located near roadways with the highest traffic volume and at separation distances most likely to produce the highest concentrations. For microscale traffic corridor sites, the location must be greater than or equal 5.0 meters and less than or equal to 15 meters from the major roadway. For the microscale street canyon site, the location must be greater than or equal 2.0 meters and less than or equal to 10 meters from the roadway. For the middle scale site, a range of acceptable distances from the roadway is shown in Figure E-1 of this appendix. This figure also includes separation distances between a roadway and neighborhood or larger scale sites by default. Any PM probe inlet at a site, 2.0 to 15 meters high, and further back than the middle scale requirements will generally be neighborhood, urban or regional scale. For example, according to Figure E-1 of this appendix, if a PM sampler is primarily influenced by roadway emissions and that sampler is set back 10 meters from a 30,000 ADT (average daily traffic) road, the site should be classified as microscale, if the sampler's inlet height is between 2.0 and 7.0 meters. If the sampler's inlet height is between 7.0 and 15 meters, the site should be classified as middle scale. If the sampler is 20 meters from the same road, it will be classified as middle scale; if 40 meters, neighborhood scale; and if 110 meters, an urban scale.
(a) In siting near-road NO
(b) In siting NO
(a) For the reactive gases (SO
(b) For volatile organic compound (VOC) monitoring at PAMS, FEP Teflon® is unacceptable as the probe material because of VOC adsorption and desorption reactions on the FEP Teflon®. Borosilicate glass, stainless steel, or their equivalents are the acceptable probe materials for VOC and carbonyl sampling. Care must be taken to ensure that the sample residence time is kept to 20 seconds or less.
(c) No matter how nonreactive the sampling probe material is initially, after a period of use, reactive particulate matter is deposited on the probe walls. Therefore, the time it takes the gas to transfer from the probe inlet to the sampling device is critical. Ozone in the presence of nitrogen oxide (NO) will show significant losses, even in the most inert probe material, when the residence time exceeds 20 seconds.
Table E-3 of this appendix presents a summary of the general requirements for probe siting criteria with respect to distances and heights. Table E-3 requires different elevation distances above the ground for the various pollutants. The discussion in this appendix for each of the pollutants describes reasons for elevating the monitor or probe inlet. The differences in the specified range of heights are based on the vertical concentration gradients. For source oriented and near-road monitors, the gradients in the vertical direction are very large for the microscale, so a small range of heights are used. The upper limit of 15 meters is specified for the consistency between pollutants and to allow the use of a single manifold for monitoring more than one pollutant.
(a) For all O
(b) Middle scale CO and NO
(c) Microscale near-road monitoring sites are required to have monitoring paths greater than or equal 2.0 meters and less than or equal to 7.0 meters above ground level.
(d) For microscale carbon monoxide monitors that are being used to measure concentrations near roadways, the monitoring path must be greater than or equal 2.0 meters and less than or equal to 7.0 meters above ground level. If the microscale carbon monoxide monitors measuring concentrations near roadways are in downtown areas or urban street canyons, the monitoring path must be greater than or equal 2.5 meters and less than or equal to 3.5 meters above ground level and at least 90
(a) It is important to understand the monitoring objective for a particular site in order to interpret this requirement. Local minor sources of a primary pollutant, such as SO
(b) Similarly, local sources of nitric oxide (NO) and ozone-reactive hydrocarbons can have a scavenging effect causing unrepresentatively low concentrations of O
(a) Obstacles may scavenge SO
(b) A monitoring path located near or along a vertical wall is undesirable because air moving along the wall may be subject to removal mechanisms. At least 90 percent of the monitoring path for open path analyzers must have unrestricted airflow with no obstructions (as defined in paragraph (a) of this section) in a continuous arc of at least 270 degrees. An unobstructed continuous arc of 180 degrees is allowable when the applicable network design criteria specified in appendix D of this part require monitoring in street canyons and the monitoring path is located on the side of a building. This arc must include the predominant wind direction for the season of greatest pollutant concentration potential.
(c) Special consideration must be given to the use of open path analyzers given their inherent potential sensitivity to certain types of interferences and optical obstructions. A monitoring path must be clear of all trees, brush, buildings, plumes, dust, or other optical obstructions, including potential obstructions that may move due to wind, human activity, growth of vegetation, etc. Temporary optical obstructions, such as rain, particles, fog, or snow, should be considered when siting an open path analyzer. Any of these temporary obstructions that are of sufficient density to obscure the light beam will negatively affect the ability of the open path analyzer to continuously measure pollutant concentrations. Transient, but significant obscuration of especially longer measurement paths, could occur as a result of certain meteorological conditions (
(d) A sampling station with a monitoring path located closer to an obstacle than required by the criteria in this section should be classified as middle scale or microscale, rather than neighborhood or urban scale, since the measurements from such a station would more closely represent these smaller scales.
(e) For near-road monitoring stations, the monitoring path shall have an unobstructed air flow, where no obstacles exist at or above the height of the monitoring path, between the monitoring path and the outside nearest edge of the traffic lanes of the target road segment.
(a) Trees can provide surfaces for SO
(b) The scavenging effect of trees is greater for O
(c) Beginning January 1, 2024, microscale sites of any air pollutant shall have no trees or shrubs located at or above the line-of-sight fetch between the monitoring path and the source under investigation,
3.5 Spacing from Roadways
In siting an O
(a) Near-road microscale CO monitoring sites, including those located in downtown areas, urban street canyons, and other near-road locations such as those adjacent to highly trafficked roads, are intended to provide a measurement of the influence of the immediate source on the pollution exposure on the adjacent area.
(b) Microscale CO monitoring paths in downtown areas or urban street canyon locations shall be located a minimum distance of 2.0 meters and a maximum distance of 10 meters from the edge of the nearest traffic lane.
(c) Microscale CO monitoring paths in downtown areas or urban street canyon locations shall be located at least 10 meters from an intersection, preferably at a midblock location. Midblock locations are preferable to intersection locations because intersections represent a much smaller portion of downtown space than do the streets between them. Pedestrian exposure is probably also greater in street canyon/corridors than at intersections.
(d) Neighborhood scale CO monitoring paths in downtown areas or urban street canyon locations shall be located according to the requirements in Table E-5 of this appendix.
(a) In siting near-road NO
(b) In siting NO
The cumulative length or portion of a monitoring path that is affected by minor sources, trees, or roadways must not exceed 10 percent of the total monitoring path length.
The monitoring path length must not exceed 1.0 kilometer for open path analyzers in neighborhood, urban, or regional scale. For middle scale monitoring sites, the monitoring path length must not exceed 300 meters. In areas subject to frequent periods of dust, fog, rain, or snow, consideration should be given to a shortened monitoring path length to minimize loss of monitoring data due to these temporary optical obstructions. For certain ambient air monitoring scenarios using open path analyzers, shorter path lengths may be needed in order to ensure that the monitoring site meets the objectives and spatial scales defined in appendix D to this part. The Regional Administrator may require shorter path lengths, as needed on an individual basis, to ensure that the SLAMS sites meet the appendix D requirements. Likewise, the Administrator may specify the maximum path length used at NCore monitoring sites.
Table E-6 of this appendix presents a summary of the general requirements for monitoring path siting criteria with respect to distances and heights. Table E-6 requires different elevation distances above the ground for the various pollutants. The discussion in this appendix for each of the pollutants describes reasons for elevating the monitoring path. The differences in the specified range of heights are based on the vertical concentration gradients. For source oriented and near-road monitors, the gradients in the vertical direction are very large for the microscale, so a small range of heights are used. The upper limit of 15 meters is specified for the consistency between pollutants and to allow the use of a monitoring path for monitoring more than one pollutant.
Most sampling probes or monitors can be located so that they meet the requirements of this appendix. New sites, with rare exceptions, can be located within the limits of this appendix. However, some existing sites may not meet these requirements and may still produce useful data for some purposes. The EPA will consider a written request from the State, or where applicable local, agency to waive one or more siting criteria for some monitoring sites providing that the State or their designee can adequately demonstrate the need (purpose) for monitoring or establishing a monitoring site at that location.
4.1 For a proposed new site, a waiver may be granted only if both the following criteria are met:
4.1.1 The proposed new site can be demonstrated to be as representative of the monitoring area as it would be if the siting criteria were being met.
4.1.2 The monitor or probe cannot reasonably be located so as to meet the siting criteria because of physical constraints (
4.2 For an existing site, a waiver may be granted if either the criterion in section 4.1.1 or the criterion in 4.1.2 of this appendix is met.
4.3 Cost benefits, historical trends, and other factors may be used to add support to the criteria in sections 4.1.1 and 4.1.2 of this appendix; however, by themselves, they will not be acceptable reasons for the EPA to grant a waiver. Written requests for waivers must be submitted to the Regional Administrator. Granted waivers must be renewed minimally every 5 years and ideally as part of the network assessment as defined in § 58.10(d). The approval date of the waiver must be documented in the annual monitoring network plan to support the requirements of § 58.10(a)(1) and 58.10(b)(10).
1. Bryan, R.J., R.J. Gordon, and H. Menck. Comparison of High Volume Air Filter Samples at Varying Distances from Los Angeles Freeway. University of Southern California, School of Medicine, Los Angeles, CA. (Presented at 66th Annual Meeting of Air Pollution Control Association. Chicago, IL. June 24-28, 1973. APCA 73-158.)
2. Teer, E.H. Atmospheric Lead Concentration Above an Urban Street. Master of Science Thesis, Washington University, St. Louis, MO. January 1971.
3. Bradway, R.M., F.A. Record, and W.E. Belanger. Monitoring and Modeling of Resuspended Roadway Dust Near Urban Arterials. GCA Technology Division, Bedford, MA. (Presented at 1978 Annual Meeting of Transportation Research Board, Washington, DC. January 1978.)
4. Pace, T.G., W.P. Freas, and E.M. Afify. Quantification of Relationship Between Monitor Height and Measured Particulate Levels in Seven U.S. Urban Areas. U.S. Environmental Protection Agency, Research Triangle Park, NC. (Presented at 70th Annual Meeting of Air Pollution Control Association, Toronto, Canada. June 20-24, 1977. APCA 77-13.4.)
5. Harrison, P.R. Considerations for Siting Air Quality Monitors in Urban Areas. City of Chicago, Department of Environmental Control, Chicago, IL. (Presented at 66th Annual Meeting of Air Pollution Control Association, Chicago, IL. June 24-28, 1973. APCA 73-161.)
6. Study of Suspended Particulate Measurements at Varying Heights Above Ground. Texas State Department of Health, Air Control Section, Austin, TX. 1970. p.7.
7. Rodes, C.E. and G.F. Evans. Summary of LACS Integrated Pollutant Data. In: Los Angeles Catalyst Study Symposium. U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Publication No. EPA-600/4-77-034. June 1977.
8. Lynn, D.A.
9. Pace, T.G. Impact of Vehicle-Related Particulates on TSP Concentrations and Rationale for Siting Hi-Vols in the Vicinity of Roadways. OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, NC. April 1978.
10. Ludwig, F.L., J.H. Kealoha, and E. Shelar. Selecting Sites for Monitoring Total Suspended Particulates. Stanford Research Institute, Menlo Park, CA. Prepared for U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Publication No. EPA-450/3-77-018. June 1977, revised December 1977.
11. Ball, R.J. and G.E. Anderson. Optimum Site Exposure Criteria for SO
12. Ludwig, F.L. and J.H.S. Kealoha. Selecting Sites for Carbon Monoxide Monitoring. Stanford Research Institute, Menlo Park, CA. Prepared for U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Publication No. EPA-450/3-75-077. September 1975.
13. Ludwig, F.L. and E. Shelar. Site Selection for the Monitoring of Photochemical Air Pollutants. Stanford Research Institute, Menlo Park, CA. Prepared for U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Publication No. EPA-450/3-78-013. April 1978.
14. Lead Analysis for Kansas City and Cincinnati, PEDCo Environmental, Inc., Cincinnati, OH. Prepared for U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Contract No. 66-02-2515, June 1977.
15. Barltrap, D. and C.D. Strelow. Westway Nursery Testing Project. Report to the Greater London Council. August 1976.
16. Daines, R. H., H. Moto, and D. M. Chilko. Atmospheric Lead: Its Relationship to Traffic Volume and Proximity to Highways. Environ. Sci. and Technol., 4:318, 1970.
17. Johnson, D. E.,
18. Air Quality Criteria for Lead. Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC EPA-600/8-83-028 aF-dF, 1986, and supplements EPA-600/8-89/049F, August 1990. (NTIS document numbers PB87-142378 and PB91-138420.)
19. Lyman, D. R. The Atmospheric Diffusion of Carbon Monoxide and Lead from an Expressway, Ph.D. Dissertation, University of Cincinnati, Cincinnati, OH. 1972.
20. Wechter, S.G. Preparation of Stable Pollutant Gas Standards Using Treated Aluminum Cylinders. ASTM STP. 598:40-54, 1976.
21. Wohlers, H.C., H. Newstein and D. Daunis. Carbon Monoxide and Sulfur Dioxide Adsorption On and Description From Glass, Plastic and Metal Tubings. J. Air Poll. Con. Assoc. 17:753, 1976.
22. Elfers, L.A. Field Operating Guide for Automated Air Monitoring Equipment. U.S. NTIS. p. 202, 249, 1971.
23. Hughes, E.E. Development of Standard Reference Material for Air Quality Measurement. ISA Transactions, 14:281-291, 1975.
24. Altshuller, A.D. and A.G. Wartburg. The Interaction of Ozone with Plastic and Metallic Materials in a Dynamic Flow System. Intern. Jour. Air and Water Poll., 4:70-78, 1961.
25. Code of Federal Regulations. 40 CFR 53.22, July 1976.
26. Butcher, S.S. and R.E. Ruff. Effect of Inlet Residence Time on Analysis of Atmospheric Nitrogen Oxides and Ozone, Anal. Chem., 43:1890, 1971.
27. Slowik, A.A. and E.B. Sansone. Diffusion Losses of Sulfur Dioxide in Sampling Manifolds. J. Air. Poll. Con. Assoc., 24:245, 1974.
28. Yamada, V.M. and R.J. Charlson. Proper Sizing of the Sampling Inlet Line for a Continuous Air Monitoring Station. Environ. Sci. and Technol., 3:483, 1969.
29. Koch, R.C. and H.E. Rector. Optimum Network Design and Site Exposure Criteria for Particulate Matter, GEOMET Technologies, Inc., Rockville, MD. Prepared for U.S. Environmental Protection Agency, Research Triangle Park, NC. EPA Contract No. 68-02-3584. EPA 450/4-87-009. May 1987.
30. Burton, R.M. and J.C. Suggs. Philadelphia Roadway Study. Environmental Monitoring Systems Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, N.C. EPA-600/4-84-070 September 1984.
31. Technical Assistance Document for Sampling and Analysis of Ozone Precursors. Atmospheric Research and Exposure Assessment Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. EPA 600/8-91-215. October 1991.
32. Quality Assurance Handbook for Air Pollution Measurement Systems: Volume IV. Meteorological Measurements. Atmospheric Research and Exposure Assessment Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. EPA 600/4-90-0003. August 1989.
33. On-Site Meteorological Program Guidance for Regulatory Modeling Applications. Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. EPA 450/4-87-013. June 1987F.
34. Johnson, C., A. Whitehill, R. Long, and R. Vanderpool. Investigation of Gaseous Criteria Pollutant Transport Efficiency as a Function of Tubing Material. U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. EPA/600/R-22/212. August 2022.
35. Hannah Halliday, Cortina Johnson, Tad Kleindienst, Russell Long, Robert Vanderpool, and Andrew Whitehill. Recommendations for Nationwide Approval of Nafion
1.1
2.1
2.2
2.2.1
a. The reporting area(s) (the MSA or subdivision of the MSA).
b. The reporting period (the day for which the AQI is reported).
c. The main pollutant (the pollutant with the highest index value).
d. The AQI (the highest index value).
e. The category descriptor and index value associated with the AQI and, if choosing to report in a color format, the associated color. Use only the following descriptors and colors for the six AQI categories:
f. The pollutant specific sensitive groups for any reported index value greater than 100. The sensitive groups for each pollutant are identified as part of the periodic review of the air quality criteria and the NAAQS. For convenience, the EPA lists the relevant groups for each pollutant in the most recent reporting guidance (Technical Assistance Document for the Reporting of Daily Air Quality), which can be found at
2.2.2
a. Appropriate health and cautionary statements.
b. The name and index value for other pollutants, particularly those with an index value greater than 100.
c. The index values for sub-areas of your MSA.
d. Causes for unusually high AQI values.
e. Pollutant concentrations.
f. Generally, the AQI report applies to an area's MSA only. However, if a significant air quality problem exists (AQI greater than 100) in areas significantly impacted by the MSA but not in it (for example, O
2.3.
a. Reporting the AQI sub-daily is recommended, but not required, to provide more timely air quality information to the public for making health-protective decisions.
b. Submitting hourly data in real-time to the EPA's AirNow (or future analogous) system is recommended, but not required, and assists the EPA in providing timely air quality information to the public for making health-protective decisions.
c. Submitting hourly data for appropriate monitors (referenced in section 3.2 of this appendix) satisfies the daily AQI reporting requirement because the AirNow system makes daily and sub-daily AQI reports widely available through its website and other communication tools.
d. Forecasting the daily AQI provides timely air quality information to the public and is recommended but not required. Sub-daily forecasts are also recommended, especially when air quality is expected to vary substantially throughout the day, like during wildfires. Long-term (multi-day) forecasts can also be made available when useful.
2.4.
a. If the index value for a particular pollutant remains below 50 for a season or year, then it may be excluded from the calculation of the AQI in section 3 of this appendix.
b. If all index values remain below 50 for a year, then the AQI may be reported at the discretion of the reporting agency. In subsequent years, if pollutant levels rise to where the AQI would be above 50, then the AQI must be reported as required in section 2 of this appendix.
c. As previously mentioned in section 2.3 of this appendix, submitting hourly data in real-time from appropriate monitors (referenced in section 3.2 of this appendix) to the EPA's AirNow (or future analogous) system satisfies the daily AQI reporting requirement.
3.1
3.2
Reference for relating non-approved PM measurements to approved methods (Eberly, S., T. Fitz-Simons, T. Hanley, L. Weinstock., T. Tamanini, G. Denniston, B. Lambeth, E. Michel, S. Bortnick. Data Quality Objectives (DQOs) For Relating Federal Reference Method (FRM) and Continuous PM
3.3
3.4
a. The AQI is the highest value calculated for each pollutant as follows:
i. Identify the highest concentration among all of the monitors within each reporting area and truncate as follows:
(B) [Reserved]
ii. Using table 2 to this appendix, find the two breakpoints that contain the concentration.
iii. Using equation 1 to this appendix, calculate the index.
iv. Round the index to the nearest integer.
b. If the concentration is equal to a breakpoint, then the index is equal to the corresponding index value in table 2 to this appendix. However, equation 1 to this appendix can still be used. The results will be equal. If the concentration is between two breakpoints, then calculate the index of that pollutant with equation 1. It should also be noted that in some areas, the AQI based on 1-hour O
c. If the concentration is larger than the highest breakpoint in table 2 to this appendix then the last two breakpoints in table 2 may be used when equation 1 to this appendix is applied.
d. Using table 2 and equation 1 to this appendix, calculate the index value for each of the pollutants measured and select the one that produces the highest index value for the AQI. For example, if a PM
i. Find the breakpoints for PM
ii. Find the breakpoints for 1-hour O
iii. Find the breakpoints for 8-hour O
iv. Apply equation 21 to this appendix for 210 µg/m
v. Apply equation 3 to this appendix for 0.156 ppm, 1-hour O
vi. Apply equation 4 to this appendix for 0.130 ppm, 8-hour O
vii. Find the maximum, 206. This is the AQI. A minimal AQI report could read: “Today, the AQI for my city is 206, which is Very Unhealthy, due to ozone.” It would then reference the associated sensitive groups.
Environmental Protection Agency (EPA).
Final rule.
The U.S. Environmental Protection Agency (EPA) is finalizing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Taconite Iron Ore Processing. Specifically, the EPA is finalizing maximum achievable control technology (MACT) standards for mercury (Hg) and establishing revised emission standards for hydrogen chloride (HCl) and hydrogen fluoride (HF). This final action ensures that emissions of all hazardous air pollutants (HAP) emitted from the Taconite Iron Ore Processing source category are regulated.
This final rule is effective March 6, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register (FR) as of March 6, 2024. The incorporation by reference of certain other material listed in the rule was approved by the Director of the Federal Register as of October 26, 2020.
The EPA established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0664. All documents in the docket are listed on the
For questions about this final action, contact David Putney, Sector Policies and Programs Division (D243-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-2016; email address:
Table 1 of this preamble lists the NESHAP and associated regulated industrial source category that is the
In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this final action at
Under Clean Air Act (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 (D.C. Circuit) by May 6, 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
In the
The EPA is also finalizing revised standards for HCl and HF pursuant to CAA section 112(d)(6). CAA section 112(d)(6) requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years.
The Taconite Iron Ore Processing NESHAP (codified at 40 Code of Federal Regulations (CFR) part 63, subpart RRRRR) applies to each new or existing ore crushing and handling operation, ore dryer, pellet indurating furnace, and finished pellet handling operation at a taconite iron ore processing plant that is (or is part of) a major source of HAP emissions. Taconite iron ore processing plants separate and concentrate iron ore from taconite, a low-grade iron ore containing 20- to 25-percent iron, and produce taconite pellets, which are 60- to 65-percent iron. The current NESHAP includes particulate matter (PM) limits that, prior to this final action, served as a surrogate for particulate metal HAP, HCl, and HF emissions. The existing PM emissions limits were summarized in table 2 of the proposal (see 88 FR 30917; May 15, 2023). The current NESHAP does not presently include standards for Hg emissions.
There are currently eight taconite iron ore processing plants in the United States: six plants are located in Minnesota and two are located in Michigan. This includes the Empire Mining facility in Michigan, which maintains an air quality permit to operate, but has been indefinitely idled since 2016 and is therefore not included
On May 15, 2023, the EPA published a proposal in the
For each issue, this section provides a description of what we proposed and what we are finalizing, a summary of key comments and responses, and the EPA's rationale for the final decisions and amendments. For all comments not discussed in this preamble, comment summaries and the EPA's responses can be found in the document,
As described in the May 15, 2023, proposal (88 FR 30917), we proposed MACT standards for Hg for new and existing indurating furnaces that reflected the MACT floor level of control, based on the 99-percent upper prediction limit (UPL), of 1.4 × 10
For the proposal, in addition to calculating the MACT floor, pursuant to CAA section 112(d)(2), we also assessed more stringent “beyond-the-floor” (BTF) regulatory options for the Hg MACT standards. As discussed in the proposal (88 FR 30923), unlike the MACT floor's minimum stringency requirements, the EPA must examine various impacts of the more stringent BTF regulatory options in determining whether MACT standards are to reflect BTF requirements. These impacts include the cost of achieving additional emissions reductions beyond those achieved by the MACT floor level of control, any non-air quality health and environmental impacts that would result from imposing controls BTF, and energy requirements of such BTF measures. If the EPA concludes that the more stringent regulatory options have unreasonable impacts, the EPA selects the MACT floor level of control as MACT. However, if the EPA concludes that impacts associated with BTF levels of control are reasonable in light of additional HAP emissions reductions achieved, then the EPA selects those BTF levels as MACT.
We considered BTF regulatory options that were 10, 20, 30, and 40 percent more stringent than the MACT floor and calculated the capital and annual costs as well as secondary impacts associated with each option. For a detailed discussion of our analysis of emissions reductions and potential secondary impacts developed for the proposal, please see the memorandum,
We estimate that the final Hg emissions averaging compliance alternative will reduce Hg emissions by 247 pounds per year, if Hibbing and Minntac elect to demonstrate compliance through the emissions averaging compliance alternative by each facility installing mercury controls on two furnaces and averaging the emissions across all furnaces located at their facility. We expect that, should Hibbing and Minntac elect to demonstrate compliance through the emissions averaging compliance alternative, the Hg reductions would still be greater than the reductions we anticipate would be achieved through unit-by-unit compliance with the MACT floor level of control. For additional details, please refer to section IV.A.1 of the proposal preamble (88 FR 30925). More information on the final Hg standards, including the detailed cost estimates for the Hg emissions averaging compliance alternative, may be found in the memorandum,
The EPA reviewed the capital cost information submitted by industry during the comment period and found the information submitted consisted of a total capital cost for equipment. However, no breakdown was provided from which we could ascertain what was included in the cost and little information was provided on how the costs were derived. The lack of detail in the cost estimates combined with little supporting documentation made it impossible for the EPA to assess the accuracy of the cost estimates submitted by industry. Industry commenters indicated that the estimated equipment costs for the air pollution control equipment for the Minorca and UTAC facilities they submitted were estimated using cost data from another project at a different facility and scaled using the
We disagree with the commenters' recommendations that a retrofit factor of 1.5 or 1.6 should be applied to the capital costs with a 30-percent contingency factor. Retrofit factors account for costs directly related to the demolition, fabrication, and installation of the control system. For the venturi scrubbers we included the 3-percent contingency factor and applied a retrofit factor of 1.2 to the estimate of the total capital investment for new construction. The EPA's
A contingency factor is reserved for costs that could incur a reasonable but unanticipated increase but are not directly related to the demolition, fabrication, and installation of the system. Retrofit and contingency factors can be difficult to assess as they vary based on site-specific characteristics. Nevertheless, the EPA considers the methodology used to calculate capital and total annual costs to be a reasonable approach to estimating costs for the purposes of this rulemaking. We note that the EPA may not consider costs in determining the MACT floor, and that the cost estimates for the BTF control options identified for Hg emissions were determined to be greater than the level historically found to be cost-effective for controlling Hg emissions.
As an alternative, an owner or operator may adjust the ACI rate based on the direct measurement of Hg emitted to the atmosphere. An owner or operator must install, calibrate, maintain, and operate CEMS to measure Hg emissions from each emission stack associated with the indurating furnace to use this alternative.
Several other commenters recommended the EPA set a BTF Hg standard and recommended the standard be at least 30-40 percent more stringent than the MACT floor. The commenters stated that additional Hg reductions can be achieved and that a more stringent Hg standard is warranted due to the bioaccumulative nature of Hg. The commenter noted that many water bodies located near taconite facilities already have fish consumption advisories, which commenters noted impact the rights of tribes to exercise their traditional life practices. One commenter noted that tribes have a particular interest in Hg emissions due to the Hg-related fish consumption advisories that have been issued by Minnesota since the 1970s and by the Fond du Lac Tribe beginning in 2000. One commenter stated that the 30
The EPA recognizes the Federal government's trust responsibility, which derives from the historical relationship between the Federal government and Indian Tribes. The EPA acts consistently with the Federal government trust responsibility by implementing the statutes it administers and consulting with and considering the interests of tribes when taking actions that may affect them. As we noted in the proposal, the EPA consulted with Tribal government officials during the development of this rule. The EPA's Office of Air and Radiation held a meeting with the Fond du Lac Band of Lake Superior Chippewa Reservation and the Leech Lake Band of Ojibwe Reservation on January 12, 2022, to discuss the EPA's CAA section 114 information request, and to ensure that the views of affected tribes were taken into consideration in the rulemaking process in accordance with the
The Agency recognizes the concerns raised by numerous Tribal commenters regarding impacts to treaty fishing and other resource rights. However, for the reasons explained below, the EPA is declining to set BTF standards for Hg, based on the statutory factors that we are required to consider pursuant to CAA section 112(d)(2) when assessing whether to set MACT standards more stringent than the MACT floor level of control. These statutory factors include the cost of achieving such emission reduction, and any non-air quality health and environmental impacts and energy requirements. As discussed in paragraphs later in this section, the cost-effectiveness values associated with BTF standards for this Taconite Iron Ore Processing rule are well above the cost-effectiveness values that EPA has historically accepted when considering BTF options for regulating mercury emissions. We note that the historic acceptable cost-effectiveness values for mercury (
Section 112(d) of the CAA requires the EPA to set emissions standards for HAP emitted by sources in each source category and subcategory listed under CAA section 112(c). The MACT standards for existing sources must be at least as stringent as the average emissions limitation achieved by the best performing 12 percent of existing sources (for which the Administrator has emissions information) or the best performing five sources for source categories with less than 30 sources (CAA sections 112(d)(3)(A) and (B)). This level of minimum stringency is called the MACT floor. For new sources, MACT standards must be at least as stringent as the control level achieved in practice by the best controlled similar source (CAA section 112(d)(3)). The EPA may not consider costs or other impacts in determining the MACT floor.
Section 112(d)(2) of the CAA also requires the EPA to examine emission standards more stringent than the MACT floor, which the EPA refers to as BTF control options. Unlike standards set at the MACT floor level of control, when assessing whether to require emission standards more stringent than the MACT floor, the EPA must consider the cost of achieving such emission reduction, and any non-air quality health and environmental impacts and energy requirements. The EPA's BTF analysis evaluated these factors in determining whether to establish Hg standards more stringent than the MACT floor. In developing this final rule, we evaluated Hg emission limits more stringent than the MACT floor after adjusting estimates of Hg emissions, Hg emission reductions, and control costs as discussed above, including those BTF limits suggested by commenters, to assess whether a BTF option was technically achievable and cost-effective. We estimate that the total capital costs and total annual costs would range from a low of $137 million and $92 million, respectively, for a limit that is 10 percent more stringent than the floor to a high of $148 million and $102 million, respectively, for a limit that is 40 percent more stringent than the floor. The incremental cost effectiveness for the BTF options examined varied from a low of $46,266 per pound of Hg reduced for 30 percent more stringent than the floor to a high of $91,140 per pound of Hg reduced for 40 percent more stringent than the floor. These values are well above the $/pound of Hg reduced that we have historically found to be cost-effective when considering BTF options for regulating Hg emissions. Where EPA has taken costs into account, the Agency has finalized standards for mercury with cost effectiveness estimates of up to $32,000/lb Hg reduced (adjusted to 2024 dollars). See Mercury Cell Chlor-Alkali Plants Residual Risk and Technology Review (87 FR 27002, May 6, 2022); 2011 Mercury and Air Toxics (MATS) final rule. To date, these are the highest cost-effectiveness values that we have accepted in the air toxics program for any HAP (except for maybe a few exceptions such as dioxins and furans), largely because of the toxicity and nature of Hg. While we conclude that mercury standards more stringent than the MACT floor are not cost-effective, we note that as a result of the revisions to the rule being finalized in this rulemaking, we will receive compliance test information that will allow us to evaluate our conclusions and potentially inform appropriate future
The commenters said the new Hg standards will help reduce Hg deposition in the Great Lakes Region and improve public health. The commenters asserted that taconite iron ore processing plants in Minnesota and Michigan have a significant impact on the natural resources of the upper Great Lakes Region and the elevated Hg levels in fish and bird populations. Several commenters mentioned the statewide fish consumption advisories for Hg in Minnesota, Michigan, and Wisconsin and noted several water bodies in these states are listed as impaired for aquatic consumption due to Hg. The commenters asserted that the new Hg standards will reduce the impact of Hg on public health and the environment, provide additional protection to recreational and subsistence fish consumers in national parks and surrounding communities, and protect natural resources that are of cultural significance to many local communities.
We are finalizing MACT standards for Hg for new and existing indurating furnaces that reflect the MACT floor level of control, based on the 99-percent UPL, of 1.4 × 10
Owners and operators may demonstrate compliance with the new Hg standards in one of two ways. Under the first option, an owner or operator may demonstrate compliance by completing performance testing and establishing operating limits for each control device used to comply with the Hg standard. The final rule clarifies that performance testing must be performed when the production rate is equal to or greater than 90 percent of the capacity of the indurating furnace. If the performance testing cannot be performed when the production rate is equal to or greater than 90 percent of the production rate capacity of the furnace, the owner or operator may complete testing at a lower production rate if they receive approval from the delegated authority. An owner or operator selecting this option must install and operate continuous parameter monitoring systems (CPMS) to monitor the parameters specified in 40 CFR 63.9631(g). An owner or operator must take corrective action when an established operating limit is exceeded.
The second option by which an owner or operator may demonstrate compliance is through the installation and operation of CEMS for Hg. The CEMS must be installed, calibrated, maintained, and operated in accordance with the procedures specified in 40 CFR 63.9631(j). An owner or operator selecting this approach is not required to establish operating limits, install and operate CPMS, or complete the initial and periodic performance testing for Hg emissions.
As discussed in section III.A.2 of this preamble, the final rule includes an option for adjusting the carbon injection rate based on the taconite pellet production level. The facility has the option of establishing operating limits for different production rates by conducting performance tests at the maximum, minimum and median taconite pellet production rates to develop a relationship between carbon injection rate and taconite pellet production rate or by adjusting the ACI rate based on Hg emissions data collected by CEMS. Facilities that elect to adjust the carbon injection rate based on taconite production levels will have lower compliance costs due to lower annual consumption of activated carbon.
Each owner or operator must prepare a preventive maintenance plan and keep records of calibration and accuracy checks of the CPMS or CEMS to document proper operation and maintenance of all monitoring systems used to demonstrate compliance with the applicable Hg standard.
As described in the May 15, 2023, proposal (88 FR 30917), we proposed to revise the numerical emission limits for HCl and HF, pursuant to CAA section 112(d)(6). CAA section 112(d)(6) requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years; we refer to such action under CAA section 112(d)(6) as a “technology review.” The EPA previously completed a technology review for the Taconite Iron Ore Processing source category in 2020 (85 FR 45476; July 28, 2020). In the May 15, 2023, proposal, we proposed to revise the HCl and HF standards based on new information we obtained in response to the 2022 information collection concerning emissions of these pollutants from the source category. For existing indurating furnaces, we proposed emissions standards of 4.4 × 10
The EPA revised the units of measure for the Tilden HCl and HF emission data based on the comments we received from industry. As we explained in the proposal, the HCl and HF emissions data for the Tilden furnace are not used to calculate the emission limits for HCl and HF because Tilden's furnaces use dry electrostatic precipitators (ESP). In the proposal, we stated that we expect Tilden's two indurating furnaces would be able to meet the HF limit for existing furnaces without adding any air pollution control devices but that we expect Tilden would be required to add air pollution control devices to meet the proposed HCl emission standard. Although the revised emission rates for Tilden are slightly lower than the emissions rates used for the proposal, we expect that Tilden's furnaces would still need to add air pollution controls to meet the HCl emission standard we are finalizing for existing furnaces. As explained in the previous paragraph, the EPA is finalizing the HCl emission standard of 4.6 × 10
We disagree with commenter that we lack the authority to revise standards pursuant to CAA section 112(d)(6) absent a showing that the revisions would reduce risk. CAA section 112(d)(6) requires the EPA to review and revise as necessary emission standards taking into account developments in practices, processes, and control technologies. This provision does not require the EPA to consider risk. We agree that the EPA has the discretion to consider cost when considering the appropriate level of control under CAA section 112(d)(6). The EPA identified dry sorbent injection (DSI) and wet scrubbers as a feasible control options and estimated the associated costs. We concluded that DSI is the lowest cost option for the indurating furnaces located at the Tilden plant. Based on this analysis, the EPA concluded the costs to comply with the numerical limits for HCl were justified and cost-effective and do not impose a significant financial burden on industry. The cost effectiveness was estimated to be $2,040 per ton of HCl removed, which is within the range the EPA has previously considered to be a cost-effective level of control for many HAP. Based on the 2022 emissions data, add on air pollution controls are not required to meet the HF emission limit. The standards we are finalizing in this action ensure HCl and HF emissions from all indurating furnaces in the source category are controlled to the same extent as the best performing indurating furnaces in the source category.
We disagree with commenters' assertion that emission limits for acid gases should be established using the existing subcategories for PM and that HCl and HF standards are not necessary for furnaces that process magnetite ore. The EPA found in the 2003 NESHAP final rule that HCl and HF are emitted by all indurating furnaces and established standards for all types of indurating furnaces in the Taconite Iron Ore Processing source category, including those indurating furnaces that process magnetite ore. Indeed, the emissions data collected in response to the 2022 CAA section 114 information request demonstrate that indurating furnaces processing magnetite ore emit measurable levels of HCl and HF even after control by wet scrubbers. HCl and HF are formed in indurating furnaces due to the presence of chlorides and fluorides in the raw materials used to form the greenballs (
Pursuant to CAA section 112(d)(1), the Administrator “may distinguish among classes, types, and sizes of sources within a category or subcategory in establishing” standards. However, as we have discussed in previous Agency actions, the CAA does not mandate that the EPA create subcategories. See,
In this final rule, we are retaining the separate PM emission limits established in the 2003 final rule for indurating furnaces processing magnetite and hematite. Based on the data available, we continue to believe it is appropriate to retain these separate PM emission standards because hematite is a finer grained ore than magnetite, and processing of hematite in an indurating furnace results in higher PM emissions than processing magnetite. However, we are declining to subcategorize taconite indurating furnaces for purposes of regulating Hg or acid gas emissions. As explained previously, pursuant to CAA section 112(d)(1), the EPA has the discretion to subcategorize sources for the purpose of setting emission standards under CAA section 112, but is not required to do so. As we also explained, where the EPA elects to subcategorize sources, we typically do so for the purpose of setting standards for specific HAP where the basis for the subcategorization is related to an effect on HAP emissions that is due to a difference in class, type, or size of the sources. The differences in emissions of HCl and HF among taconite indurating furnaces are largely the result of differing controls utilized by sources rather than a result of the class, type, or size of the indurating furnaces themselves. Therefore, we conclude that the differences in HCl and HF emissions are not due to differences in the class, type, of size of taconite indurating furnaces. As a result, we do not believe it is appropriate to subcategorize taconite indurating furnaces for the purpose of regulating Hg, HCl, or HF emissions and are declining to do so in this final rule.
Based on the data available, the EPA proposed to set HCl and HF emission standards that apply to all indurating furnaces. In this action, we are finalizing emission standards for HCl and HF as discussed in section III.B.1 of this preamble. While the HCl emission standard for existing furnaces differs from what we proposed for the reasons explained in section III.B.2 of this preamble, we continue to believe it is appropriate to set numerical emission standards for HCl and HF based on the 2022 ICR data rather than to continue to rely on PM standards as a surrogate for these pollutants. While we expect that most indurating furnaces will be able to meet the revised HCl and HF limits using existing air pollution controls, the new performance testing and parametric monitoring requirements are necessary to ensure continuous compliance with the HCl and HF emission standards. The
We are finalizing numerical emission limits for HCl and HF, pursuant to CAA section 112(d)(6). We are finalizing as proposed the numerical emission limit for HCl for new indurating furnaces. We are finalizing a numerical emission limit for HCl for existing indurating furnaces which differs from the limit proposed because the final limit reflects a revision to the emissions data for the Hibbing facility, as discussed in section III.B.2 of this preamble. We are finalizing as proposed the numerical emission limits for HF for new and existing indurating furnaces. For existing indurating furnaces, we are finalizing an HCl emission limit of 4.6 × 10
We are also finalizing as proposed the requirement to complete performance testing for HCl and HF using EPA Method 26A and to establish operating limits for each control device used to comply with the HCl and HF standards, in accordance with the amended provisions of 40 CFR 63.9622. The final rule clarifies that the owner or operator must perform performance testing when the pellet production rate is equal to or greater than 90 percent of the capacity of the indurating furnace. If the performance testing cannot be performed at or above 90 percent of capacity of the indurating furnace, the owner or operator may complete testing at a lower production rate if they receive approval from the delegated authority. The owner or operator must install and operate CPMS in accordance with the requirements of 40 CFR 63.9633 and must prepare a preventive maintenance plan and keep records of calibration and accuracy checks of the CPMS to document proper operation and maintenance of each monitoring system. An owner or operator must take corrective action when an established operating limit is exceeded. The owner or operator must complete the initial performance tests within 180 calendar days of the compliance date for existing furnaces, or within 180 calendar days of startup for new furnaces. The performance tests must be repeated at least twice per 5-year permit term.
The EPA proposed amendments to the performance testing provisions that would require the owner or operator to complete a performance test on a source within 7 calendar days of initiating that performance test. This provision was included for the existing performance testing for PM, as well as for the proposed new performance testing for Hg, HCl, and HF. We received one comment that resulted in changes to the proposed requirements. The comment and our response are summarized below.
We are also finalizing as proposed changes to the electronic reporting requirements found in 40 CFR 63.9641(c) and 40 CFR 63.9641(f)(3) to reflect new procedures for reporting CBI, including adding an email address that an owner or operator may use to electronically submit compliance reports containing CBI to the OAQPS CBI Office. We received no comments on these proposed amendments.
The revisions to the MACT standards promulgated in this action are effective on March 6, 2024. For all affected sources that commence construction or reconstruction before May 15, 2023, we are finalizing, as proposed, that an owner or operator must comply with the new Hg emission standard and revised HCl and HF standards no later than 3 years after the effective date of the final rule. For all affected sources that commenced construction or reconstruction on or after May 15, 2023, we are finalizing, as proposed, that owners and operators comply with provisions by the effective date of the final rule or upon startup, whichever is later. For existing sources, CAA section 112(i)(3) requires compliance “as expeditiously as practicable, but in no event later than 3 years after the effective date of such standard” subject to certain exemptions further detailed in the statute.
The Taconite Iron Ore Processing NESHAP applies to the owner or operator of a taconite iron ore processing plant that is (or is part of) a major source of HAP emissions. A taconite iron ore processing plant is any facility engaged in separating and concentrating iron ore from taconite ore to produce taconite pellets. Taconite iron ore processing includes the following processes: liberation of the iron ore by wet or dry crushing and grinding in gyratory crushers, cone crushers, rod mills, and ball mills; concentration of the iron ore by magnetic separation or flotation; pelletizing by wet tumbling with a balling drum or balling disc; induration using a straight grate or grate kiln indurating furnace; and finished pellet handling. A major source of HAP is a plant site that emits, or has the potential to emit, any single HAP at a rate of 9.07 megagrams (10 tons) or more, or any combination of HAP at a rate of 22.68 megagrams (25 tons) or more per year from all emission sources at the plant site. There are currently seven major sources subject to the Taconite Iron Ore Processing NESHAP that are operating in the United States with six located in Minnesota and one located in Michigan. One additional major source located in Michigan, Empire Mining, is subject to the Taconite Iron Ore Processing NESHAP and has a permit to operate but has been indefinitely idled since 2016.
To meet the Hg emission limits we anticipate that five of the taconite iron ore processing plants would likely need to install additional controls on their indurating furnaces. To meet the HCl and HF emission limits, we anticipate that one additional taconite iron ore processing plant would likely need to install additional controls on their indurating furnaces. We estimate that the installation of such controls will reduce Hg emissions by 247 pounds per year (0.12 tpy) and HCl and HF emissions by 683 tpy and 36 tpy, respectively.
Indirect or secondary air emissions impacts are impacts that would result from the increased electricity usage associated with the operation of control devices (
This rule is expected to limit emissions of directly emitted PM
We estimate the total capital and annualized costs of this final rule for existing sources in the Taconite Iron Ore Processing source category will be approximately $106 million and $68 million per year, respectively. The annual costs are based on operation and maintenance of added control systems. Although this action also finalizes standards for new sources, we are not aware of any new sources being constructed now or planned for the future. No new indurating furnaces have been constructed, reconstructed or modified in more than a decade and the domestic demand for taconite pellets has decreased over the past several decades caused by the increasing use of electric arc furnaces.
The EPA assessed the potential economic impacts of this action by comparing the expected annual cost for operating the air pollution control devices to the total sales revenue for the ultimate owners of affected facilities. The expected annual cost is $10.2 million (on average) for each facility that needs air pollution controls to comply with the standards, with an estimated nationwide annual cost of $61 million per year. The six affected facilities are owned by two parent companies (U.S. Steel and Cleveland-Cliffs, Inc.). Neither parent company qualifies as a small business, and the total costs associated with this final rule are expected to be less than 1 percent of annual sales revenue per ultimate owner.
The EPA also modeled the economic impacts of the final rule using two standard partial equilibrium economic models: one for taconite iron ore pellets and one for steel mill products. The EPA linked these two partial equilibrium models by specifying interactions between supply and demand in both markets and solving for changes in prices and quantity across both markets simultaneously. These models use baseline economic data from 2019 to project the impact of the final rule on the market for taconite iron ore pellets and steel mill products. The models allow the EPA to project facility- and market-level price and quantity changes for taconite iron ore pellets and market-level price and quantity changes for steel mill products, including changes in imports and exports in both markets. The models project a 0.28 percent fall in the quantity of domestically produced taconite iron ore pellets along with a 0.63 percent increase in their price. The models also project a 0.02 percent fall in the quantity of domestically produced steel mill products along with an 0.01 percent increase in their price. Details of our economic impact estimates for sources in the Taconite Iron Ore Processing source category may be found in the document,
Consistent with the EPA's commitment to integrating environmental justice (EJ) into the Agency's actions, and following the directives set forth in multiple executive orders, the EPA evaluated the impacts of this action on communities with EJ concerns. Overall, we found that in the population living in close proximity (within 10 kilometers (km)) of facilities, the following demographic groups were above the national average: White, Native American, and people living below the poverty level. The EPA defines EJ as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income, with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.”
For the Taconite Iron Ore Processing source category, the EPA examined the potential for EJ concerns by conducting a proximity demographic analysis for the eight existing taconite iron ore processing plants (seven operating plants and one indefinitely idled). The proximity demographic analysis is an assessment of individual demographic groups in the total population living within 10 km and 50 km of the facilities. The EPA compared the data from this analysis to the national average for each of the demographic groups. Since the taconite iron ore processing facilities are very large, a radius of 10 km was used as the near facility distance for the proximity analysis. A distance closer than 10 km does not yield adequate population size for the results. A summary of the proximity demographic assessment was included in Table 5 in the proposal for this rulemaking (88 FR 30931; May 15, 2023). The results show that for the population living within 10
This action sets new standards for Hg and revised standards for HCl and HF that will reduce the annual emissions of these HAP from taconite facilities. The Hg standards will reduce the health, environmental and cultural impacts of Hg identified by tribes in their comments by requiring the five taconite facilities (UTAC, Keetac, Hibbing, Minorca, and Minntac) that have nearby Native American populations and low-income populations above the national averages to reduce Hg emissions by up to 247 pounds per year (0.12 tpy). The emission limits must be met at all times (including periods of startup, shutdown, and malfunctions) and compliance must be demonstrated through monitoring of control device operating parameters and either periodic testing or CEMS.
Additional information about these statutes and Executive Orders can be found at
This action is a “significant regulatory action” as defined in 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 economic analysis of the potential impacts associated with this action. This analysis is summarized in section IV.D of this preamble and in the document
The information collection activities in this rule have been submitted for approval to the OMB under the PRA. The ICR document that the EPA prepared has been assigned EPA ICR number 2050.10, OMB Control Number 2060-0538. You can find a copy of the ICR in the docket for this action, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.
In this action, we are finalizing changes to the reporting and recordkeeping requirements for the Taconite Iron Ore Processing NESHAP by incorporating reporting and recordkeeping requirements for the new MACT standards for Hg and the revised emission standards for HCl and HF.
Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart RRRRR).
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. When OMB approves this ICR, the Agency will announce that approval in the
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. The Agency confirmed through responses to a CAA section 114 information request that there are only seven taconite iron ore processing plants currently operating in the United States and that these plants are owned by two parent companies that do not meet the definition of small businesses, as defined by the U.S. Small Business Administration.
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. This action imposes no enforceable duty on any state, local, or Tribal governments or the private sector.
This action does not have federalism implications. It will not have 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. The Executive Order defines Tribal implications as “actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” The amendments in this action would not have a substantial direct effect on one or more tribes, change the relationship between the Federal Government and tribes, or affect the distribution of power
Although this action does not have Tribal implications as defined by Executive Order 13175, consistent with the
This action involves technical standards. Therefore, the EPA conducted searches for the Taconite Iron Ore Processing NESHAP through the Enhanced National Standards Systems Network (NSSN) Database managed by the American National Standards Institute (ANSI). We also conducted a review of VCS organizations and accessed and searched their databases. We conducted searches for EPA Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 5, 5D, 17, 26A, 29 and 30B. During the 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 ordered a copy of the standard and 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 referenced methods. The EPA may reconsider determinations of impracticality when additional information is available for any particular VCS.
No VCS were identified for EPA Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 4, 5, 5D, 17 or 26A. One VCS was identified as an acceptable alternative to EPA Methods 3B, 29 and 30B.
The EPA is allowing use of the VCS 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)” as an acceptable alternative to EPA Method 29 (Hg portion only) as a method for measuring Hg concentrations ranging from approximately 0.5 to 100 micrograms per normal cubic meter (µg/Nm
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 EJ concerns. The assessment of populations in close proximity of taconite iron ore processing plants shows Native American and low-income populations are higher than the national average (see section IV.E of this preamble). The higher percentages of Native American populations are near the UTAC and Minntac facilities. The higher percentages of low-income populations are near the Keetac, Hibbing, Minorca, and Minntac facilities. The EPA believes that this action is likely to reduce existing disproportionate and adverse effects on low-income populations and/or indigenous peoples. The EPA is finalizing new MACT standards for Hg and revised standards for HCl and HF. The EPA expects that at least five facilities would have to implement control measures to reduce Hg emissions to comply with the new Hg MACT standard (including the UTAC, Keetac, Hibbing, Minorca and Minntac facilities) and one facility would need to implement control measures to reduce HCl emissions to comply with the revised standard for HCl (the Tilden facility). HAP exposures for indigenous peoples and low-income individuals
Executive Order 13045 (62 FR 19885; April 23, 1997) 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 it is not significant as defined in Executive Order 12866(3)(f)(1), and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. In 2020, the EPA conducted a residual risk assessment and determined that risk from the Taconite Iron Ore Processing source category was acceptable, and the standards provided an ample margin of safety to protect public health (see 85 FR 45476 and Docket ID No. EPA-HQ-OAR-2017-0664-0163). For this rulemaking, we updated that risk analysis using new emissions data that the EPA received for some HAP emissions sources at the taconite facilities. We determined that these new HAP emissions estimates would not significantly change our previous estimates of the human health risk posed by the Taconite Iron Ore Processing source category. In this action the EPA is promulgating new emission standards for one previously unregulated pollutant (Hg) and revised emissions standards for two currently regulated pollutants (HCl and HF). These emissions standards will reduce Hg, HCl and HF emissions and thereby reduce children's exposure to these harmful HAP. We estimate that the installation of controls will reduce HCl and HF emissions by 683 tpy and 36 tpy, respectively, and will reduce Hg emissions by up to 247 pounds per year (0.12 tpy).
This action's health and risk assessments are protective of the most vulnerable populations, including children, due to how we determine exposure and through the health benchmarks that we use. Specifically, the risk assessments we perform assume a lifetime of exposure, in which populations are conservatively presumed to be exposed to airborne concentrations at their residence continuously, 24 hours per day for a 70-year lifetime, including childhood. With regards to children's potentially greater susceptibility to noncancer toxicants, the assessments rely on the EPA's (or comparable) hazard identification and dose-response values that have been developed to be protective for all subgroups of the general population, including children. For more information on the risk assessment methods, see the risk report for the July 28, 2020, final Taconite residual risk and technology review (RTR) rule (85 FR 45476), which is available in the docket. Therefore, the rulemaking finalizes actions that will result in health benefits to children by reducing the level of HAP emissions emitted from taconite iron ore processing plants.
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 that this action is not likely to have any adverse energy effects because it contains no regulatory requirements that will have an adverse impact on productivity, competition, or prices in the energy sector.
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, air pollution control, hazardous substances, incorporation by reference, mercury, hydrogen chloride, hydrogen fluoride, 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
(i) * * *
(104) 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 §§ 63.9621(d); table 5 to subpart UUUUU; appendix A to subpart UUUUU.
(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 October 30, 2006, except as specified in paragraph (f) of this section.
(b) If you have a new affected source and its initial startup date is on or before October 30, 2003, you must comply with each emission limitation, work practice standard, and operation and maintenance requirement in this subpart that applies to you by October 30, 2003, except as specified in paragraph (f) of this section.
(c) If you have a new affected source and its initial startup date is after October 30, 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, except as specified in paragraph (f) of this section.
(d) If your taconite iron ore processing plant is an area source that becomes a major source of HAP, the compliance dates in paragraphs (d)(1) and (2) of this section apply to you.
(1) Any portion of the taconite iron ore processing plant that is a new affected source or a new reconstructed source must be in compliance with this subpart upon startup.
(2) All other parts of the taconite iron ore processing plant must be in compliance with this subpart no later than 3 years after the plant becomes a major source.
(e) You must meet the notification and schedule requirements in § 63.9640. Several of these notifications must be submitted before the compliance date for your affected source.
(f) If you have an affected indurating furnace that commenced construction before May 15, 2023, you must comply with the requirements in paragraphs (f)(1) through (7) of this section by March 8, 2027. If you have an affected indurating furnace that commenced construction or reconstruction on or after May 15, 2023, you must comply with the requirements in paragraphs (f)(1) through (7) of this section by March 6, 2024 or the date of initial startup, whichever is later.
(1) All applicable emission limits for mercury, hydrogen chloride, and hydrogen fluoride in tables 2 and 3 to this subpart.
(2) All applicable operating limits in § 63.9590(b)(5) through (8), established in accordance with § 63.9622(g) through (i), for each control device used to comply with the mercury, hydrogen chloride, and hydrogen fluoride emission limits.
(3) All applicable compliance requirements in §§ 63.9600, 63.9610, 63.9623, 63.9625, and 63.9637(a).
(4) The applicable performance testing or continuous emissions monitoring system (CEMS) requirements for mercury in §§ 63.9620(k), 63.9621(d), and 63.9630.
(5) All applicable performance testing requirements in §§ 63.9620(l), 63.9621(d), and 63.9630.
(6) The requirements to install and maintain monitoring equipment in § 63.6332(g) through (i) and the monitoring requirements in §§ 63.9631, 63.9633, and 63.9634 for each control device used to comply with the mercury, hydrogen chloride and hydrogen fluoride emission limits.
(7) The notification, reporting and recordkeeping requirements in §§ 63.9640, 63.9641, 63.9642, and 63.9643 applicable to the mercury, hydrogen chloride, and hydrogen fluoride emission standards.
(a) You must meet each emission limit in tables 1 through 3 to this subpart that applies to you by the applicable compliance date specified in § 63.9583.
(b) You must meet each applicable operating limit for control devices in paragraphs (b)(1) through (8) of this section that applies to you by the applicable compliance date specified in § 63.9583. You are not required to establish and comply with operating limits for control devices used to reduce mercury emissions when you are using a CEMS to monitor and demonstrate compliance with the mercury emission limit in table 2 to this subpart.
(1) Except as provided in paragraph (b)(2) of this section, for each wet scrubber applied to meet any particulate matter emission limit in table 1 to this subpart, you must maintain the daily average pressure drop and daily average scrubber water flow rate at or above the minimum levels established in § 63.9622.
(2) On or before January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, for each dynamic wet scrubber applied to meet any particulate matter emission limit in table 1 to this subpart, you must maintain the daily average scrubber water flow rate and either the daily average fan amperage (a surrogate for fan speed as revolutions per minute) or the daily average pressure drop at or above the minimum levels established during the initial performance test. After January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, for each dynamic wet scrubber applied to meet any particulate matter emission limit in table 1 to this subpart, you must maintain the daily average scrubber water flow rate and the daily average fan amperage (a surrogate for fan speed as revolutions per minute) at or above the minimum levels established in § 63.9622.
(3) For each dry electrostatic precipitator (ESP) applied to meet any particulate matter emission limit in Table 1 to this subpart, you must meet the operating limits in paragraph (b)(3)(i) or (ii) of this section.
(i) Maintain the 6-minute average opacity of emissions exiting the control device stack at or below the level established during the initial performance test.
(ii) Maintain the daily average secondary voltage and daily average secondary current for each field at or above the minimum levels established during the initial performance test.
(4) For each wet ESP applied to meet any particulate matter emission limit in table 1 to this subpart, you must meet the operating limits in paragraphs (b)(4)(i) through (iii) of this section.
(i) Maintain the daily average secondary voltage for each field at or above the minimum levels established during the initial performance test.
(ii) Maintain the daily average stack outlet temperature at or below the maximum levels established during the initial performance test.
(iii) Maintain the daily average water flow rate at or above the minimum levels established during the initial performance test.
(5) For each wet scrubber and wet ESP used to meet the hydrogen chloride and hydrogen fluoride emission limits in table 3 to this subpart, you must maintain the daily average scrubber water flow rate and pH greater than or equal to the operating limits established for these parameters established in § 63.9622.
(6) For each activated carbon injection (ACI) system used to meet the mercury emission limit in table 2 to this subpart, you must maintain the daily average activated carbon injection rate greater than or equal to the average activated carbon injection rate established during the most recent performance test demonstrating compliance with the applicable emission limit. In addition, you must maintain the daily average carrier gas flow rate greater than or equal to the average carrier gas flow rate established during the most recent performance test demonstrating compliance with the applicable emission limit.
(7) For each dry sorbent injection (DSI) system used to meet the hydrogen chloride and hydrogen fluoride emission limits in table 3 to this subpart, you must maintain the daily average dry sorbent injection rate greater than or equal to the average dry sorbent injection rate established during the most recent performance test. demonstrating compliance with the applicable emission limit. In addition, you must maintain the daily average carrier gas flow rate greater than or equal to the average carrier gas flow rate established during the most recent performance test demonstrating compliance with the applicable emission limit.
(8) If you use any air pollution control device other than a baghouse, wet scrubber, dynamic scrubber, dry ESP, wet ESP, ACI, or DSI, you must submit a site-specific monitoring plan in accordance with § 63.9631(f).
(c) You may petition the Administrator for approval of alternatives to the monitoring requirements in paragraphs (b)(1) through (7) of this section as allowed under § 63.8(f) and as defined in § 63.90.
(b) You must prepare, and at all times, operate according to, a written operation and maintenance plan for each control device applied to meet any particulate matter emission limit in table 1 to this subpart, mercury emission limit in table 2 to this subpart, hydrogen chloride and hydrogen fluoride emission limit in table 3 to this subpart, and to meet the requirement of each indurating furnace subject to good combustion practices (GCP). Each site-specific operation and maintenance plan must be submitted to the Administrator on or before the compliance date that is specified in § 63.9583 for your affected source. The plan you submit must explain why the chosen practices (
(a) On or before January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, you must be in compliance with the requirements in paragraphs (a)(1) through (6) of this section at all times, except during periods of startup, shutdown, and malfunction. After January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, for affected sources that commenced construction or reconstruction after September 25, 2019, you must be in compliance with the emission limitations, standards, and operation and maintenance requirements for the particulate matter emission standards in this subpart at all times.
(d) On and after the applicable compliance date specified in § 63.9583(f), you must be in compliance with all applicable emission limitations for mercury, hydrogen chloride and hydrogen fluoride in tables 2 and 3 to this subpart and with the requirements in paragraphs (d)(1) through (6) of this section at all times.
(1) All applicable operating limits in § 63.9590(b)(5) through (8).
(2) All applicable operation and maintenance requirements in § 63.9600 for control devices and monitoring equipment used to comply with the emissions limits.
(3) The requirements in § 63.9631(j), if you use emissions averaging to demonstrate compliance with the mercury standards.
(4) The requirements in § 63.9631(k), if you use continuous emissions monitoring system(s) (CEMS) to demonstrate compliance with the mercury standards.
(5) The requirements in § 63.9634(n), if you elect to adjust the activated carbon injection rate based on the taconite pellet production rate.
(6) The notification, reporting and recordkeeping requirements in §§ 63.9640 through 63.9643.
The revisions and addition read as follows:
(b) * * *
(2) Initial performance tests must be completed no later than 180 calendar days after the compliance date specified in § 63.9583. Performance tests conducted between October 30, 2003, and no later than 180 days after the corresponding compliance date can be used for initial compliance demonstration, provided the tests meet the initial performance testing requirements of this subpart. For an indurating furnace with multiple stacks, the performance tests for all stacks must be completed within 7 calendar days of commencement of the performance tests, to the extent practicable, and the indurating furnace and associated control device (where applicable) operating characteristics must remain representative and consistent for the duration of the stack tests. If you determine that the performance tests cannot be completed within 7 calendar days, the Administrator must be notified within 24 hours of making that determination.
(f) * * *
(2) All emission units within a group must also have the same type of air pollution control device (
(k) For each indurating furnace, you must demonstrate initial compliance with the mercury emission limits in table 2 to this subpart in accordance with the procedures specified in either paragraph (k)(1) or (2) of this section.
(1) Complete an initial performance test on all stacks associated with each indurating furnace no later than 180 calendar days after the compliance date specified in § 63.9583(f). Performance tests conducted between March 6, 2024 and 180 days after the corresponding compliance date can be used for initial compliance demonstration, provided the tests meet the initial performance testing requirements of this subpart. For an indurating furnace with multiple stacks, the performance tests for all stacks must be completed within 7 calendar days of commencement of the performance tests, to the extent practicable, and the indurating furnace and associated control device (where applicable) operating characteristics must remain representative and consistent for the duration of the stack tests. If you determine that the performance tests cannot be completed within 7 calendar days, the Administrator must be notified within 24 hours of making that determination.
(2) You may use a 30-day rolling average of the 1-hour arithmetic average CEMS data. You must conduct a performance evaluation of each CEMS within 180 days of installation of the monitoring system. The initial performance evaluation must be conducted prior to collecting CEMS data
(l) For each indurating furnace, you must demonstrate initial compliance with the emission limits in table 3 to this subpart by conducting initial performance tests for hydrogen chloride and hydrogen fluoride on all stacks associated with each indurating furnace. Initial performance tests must be completed no later than 180 calendar days after the compliance date specified in § 63.9583(f). Performance tests conducted between March 6, 2024 and 180 days after the corresponding compliance date can be used for initial compliance demonstration, provided the tests meet the initial performance testing requirements of this subpart. For an indurating furnace with multiple stacks, the performance tests for all stacks must be completed within 7 calendar days of commencement of the performance tests, to the extent practicable, and the indurating furnace and associated control device (where applicable) operating characteristics must remain representative and consistent for the duration of the stack tests. If you determine that the performance tests cannot be conducted within 7 calendar days, the Administrator must be notified within 24 hours of making that determination.
The revisions and additions read as follows:
(a) On or before January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, you must conduct each performance test that applies to your affected source according to the requirements in § 63.7(e)(1) and paragraphs (b) and (c) of this section. After January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, you must conduct each performance test that applies to your affected source, including the initial performance tests for mercury required in § 63.9620(k)(1) and the initial performance tests for hydrogen chloride and hydrogen fluoride required in § 63.9620(l), under normal operating conditions of the affected source. The owner or operator may not conduct performance tests during periods of malfunction. The owner or operator must record the process information that is necessary to document operating conditions during the test and include in such record an explanation to support that such conditions represent normal operation. Upon request, the owner or operator shall make available to the Administrator such records as may be necessary to determine the conditions of performance tests. You must also conduct each performance test that applies to your affected source according to the requirements in paragraphs (b) and (c) of this section.
(c) For each ore dryer affected source and each indurating furnace affected source, you must determine compliance with the applicable emission limit for particulate matter in table 1 to this subpart by following the test methods and procedures in paragraphs (c)(1) through (2) of this section.
(d) For each indurating furnace subject to the initial performance testing under § 63.9620(k)(1) or (l), you must determine compliance with the applicable emission limits for mercury, hydrogen chloride and hydrogen fluoride in tables 2 and 3 to this subpart by following the test methods and procedures in paragraphs (d)(1) through (9) of this section. You are not required to complete the initial performance test for mercury emissions when you are using a CEMS in accordance with paragraph (e) of this section.
(1) The furnace must be operated at or above 90 percent of capacity throughout the duration of the performance testing. If testing cannot be performed at or above 90 percent of capacity, you must provide an explanation for the lower production rate in your performance test plan. The lower production rate must be approved by the Administrator prior to beginning performance testing. For indurating furnaces that comply with the mercury emissions limit in table 2 to this subpart by adjusting the activated carbon injection rate based on the taconite pellet production rate, you must complete the performance testing for mercury in accordance with the provisions in § 63.9634(n).
(2) Use the methods specified in paragraphs (c)(1)(i) through (iv) of this section to select sampling port locations and the number of traverse points and to determine the volumetric flow rate, dry molecular weight, and moisture content of the stack gas.
(3) Determine the concentration of mercury for each stack using Method 29 or Method 30B in 40 CFR part 60, appendix A, or the voluntary consensus standard ASTM D6784-16 (incorporated by reference, see § 63.14). For Method 29 and ASTM D6784-16, the sample volume must be at least 1.7 dry standard cubic meters (dscm) (60 dry standard cubic feet) per run. For Method 30B, each test run must be at least one hour in duration.
(4) Determine the concentration of hydrogen chloride and hydrogen fluoride for each stack using Method 26A in 40 CFR part 60, appendix A. Each test must consist of three separate runs. The minimum sample volume must be at least 2 dscm per run.
(5) During each stack test run, determine the weight of taconite pellets produced and calculate the emissions rate of each pollutant in pounds of pollutant per long ton (lb/LT) of pellets produced for each test run. The weight of taconite pellets produced must be determined by measurement using weigh hoppers, belt weigh feeders, or weighed quantities in shipments, or calculated using the bulk density and volume measurements. If any measurement result for any pollutant is reported as below the method detection limit, use the method detection limit as the measured emissions level for that pollutant when calculating the emission rate. If the furnace has more than one stack, calculate the total emissions rate for each test run by summing the emissions across all stacks, as shown in Equation 4.
(6) Calculate the average emissions rate for each furnace using the three test runs, as show in Equation 5 of this section.
(7) For each indurating furnace constructed or reconstructed on or after May 15, 2023, determine compliance with the applicable mercury emission limit in table 2 to this subpart by calculating the average emissions rate from the three test runs performed on the furnace using Equations 4 and 5 of this section.
(8) For each indurating furnace constructed or reconstructed before May 15, 2023, you must determine compliance with the applicable mercury emission limit in accordance with the procedures specified in either paragraph (d)(8)(i) or (ii) of this section.
(i) Determine compliance with the mercury limit for individual furnaces in table 2 to this subpart by calculating the average mercury emissions rate for each affected indurating furnace using Equations 4 and 5 of this section, or
(ii) Determine compliance with the mercury limit for groups of indurating furnaces in table 2 to this subpart in accordance with the method in § 63.9623(d).
(9) Determine compliance with the applicable hydrogen chloride and hydrogen fluoride emission limits in table 3 to this subpart by calculating the average emissions rate for each indurating furnace for the three test runs performed on the furnace using Equations 4 and 5 of this section.
(e) For each indurating furnace using mercury CEMS to demonstrate compliance with the applicable emission limits for mercury, you must determine compliance with the applicable mercury limit in table 2 to this subpart by using a 30-day rolling average of the 1-hour arithmetic average CEMS data, including CEMS data during startup and shutdown as defined in this subpart. The mercury CEMS must be installed, calibrated, maintained, and operated as accordance with the requirements in § 63.9631(j).
(a) For wet scrubbers subject to performance testing in § 63.9620 and operating limits for pressure drop and scrubber water flow rate in § 63.9590(b)(1), you must establish site-specific operating limits according to the procedures in paragraphs (a)(1) through (3) of this section.
(1) Using the CPMS required in § 63.9631(b), measure and record the pressure drop and scrubber water flow rate every 15 minutes during each run of the particulate matter performance test.
(2) Calculate and record the average pressure drop and scrubber water flow rate for each individual test run. Your operating limits are established as the lowest average pressure drop and the lowest average scrubber water flow rate corresponding to any of the three test runs, except as specified in paragraph (g)(2) of this section.
(3) If a rod-deck venturi scrubber is applied to an indurating furnace to meet any particulate matter emission limit in table 1 to this subpart, you may establish a lower average pressure drop operating limit by using historical average pressure drop data from a certified performance test completed on or after December 18, 2002 instead of using the average pressure drop value determined during the initial performance test, as specified in paragraph (a)(2) of this section. If historical average pressure drop data are used to establish an operating limit (
(b) On or before January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, for dynamic wet scrubbers subject to performance testing in § 63.9620 and operating limits for scrubber water flow rate and either fan amperage or pressure drop in § 63.9590(b)(2), you must establish site-specific operating limits according to the procedures in paragraphs (b)(1) and (2) of this section. After January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, for dynamic wet scrubbers subject to performance testing in § 63.9620 and operating limits for scrubber water flow rate and fan amperage in § 63.9590(b)(2), you must establish site-specific operating limits according to the procedures in paragraphs (b)(1) and (2) of this section.
(1) On or before January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, using the CPMS required in § 63.9631(b), measure and record the scrubber water flow rate and either the fan amperage or pressure drop every 15 minutes during each run of the particulate matter performance test. After January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, using the CPMS required in § 63.9631(b), measure and record the scrubber water flow rate and the fan amperage every 15 minutes during each run of the particulate matter performance test.
(2) On or before January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, calculate and record the average scrubber water flow rate and either the average fan amperage or the average pressure drop for each individual test run. Your operating limits are established as the lowest average scrubber water flow rate and either the lowest average fan amperage or pressure drop value corresponding to any of the three test runs. After January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, calculate and record the average scrubber water flow rate and the average fan amperage for each individual test run. Your operating limits are established as the lowest average scrubber water flow rate and the lowest average fan amperage value corresponding to any of the three test runs, except as specified in paragraph (g)(2) of this section.
(c) For a dry ESP subject to performance testing in § 63.9620 and operating limits in § 63.9590(b)(3), you must establish a site-specific operating limit according to the procedures in paragraphs (c)(1) or (2) of this section.
(1) If the operating limit for your dry ESP is a 6-minute average opacity of emissions value, then you must follow the requirements in paragraphs (c)(1)(i) through (iii) of this section.
(i) Using the continuous opacity monitoring system (COMS) required in § 63.9631(d)(1), measure and record the opacity of emissions from each control device stack during the particulate matter performance test.
(ii) Compute and record the 6-minute opacity averages from 24 or more data points equally spaced over each 6-minute period (
(iii) Using the opacity measurements from a performance test that meets the emission limit, determine the opacity value corresponding to the 99 percent upper confidence level of a normal distribution of the 6-minute opacity averages.
(2) If the operating limit for your dry ESP is the daily average secondary voltage and daily average secondary current for each field, then you must follow the requirements in paragraphs (c)(2)(i) and (ii) of this section.
(i) Using the CPMS required in § 63.9631(d)(2), measure and record the secondary voltage and secondary current for each dry ESP field every 15 minutes during each run of the particulate matter performance test.
(ii) Calculate and record the average secondary voltage and secondary current for each dry ESP field for each individual test run. Your operating limits are established as the lowest average secondary voltage and secondary current value for each dry ESP field corresponding to any of the three test runs.
(d) For a wet ESP subject to performance testing in § 63.9620 and operating limit in § 63.9590(b)(4), you must establish a site-specific operating limit according to the procedures in paragraphs (d)(1) and (2) of this section.
(1) Using the CPMS required in § 63.9631(e), measure and record the parametric values in paragraphs (d)(1)(i) through (iii) of this section for each wet ESP field every 15 minutes during each run of the particulate matter performance test.
(i) Secondary voltage;
(ii) Water flow rate; and
(iii) Stack outlet temperature.
(2) For each individual test run, calculate and record the average value for each operating parameter in paragraphs (d)(1)(i) through (iii) of this section for each wet ESP field. Your operating limits are established as the lowest average value for each operating parameter of secondary voltage and water flow rate corresponding to any of the three test runs, and the highest average value for each stack outlet temperature corresponding to any of the three test runs.
(e) If you use an air pollution control device other than a wet scrubber, dynamic wet scrubber, dry ESP, wet ESP, or baghouse, and it is subject to performance testing in § 63.9620, you must submit a site-specific monitoring plan in accordance with § 63.9631(f). The site-specific monitoring plan must include the site-specific procedures for demonstrating initial and continuous compliance with the corresponding operating limits.
(f) You may change the operating limits for any air pollution control device as long as you meet the requirements in paragraphs (f)(1) through (3) of this section.
(1) Submit a written notification to the Administrator of your request to conduct a new performance test to revise the operating limit.
(2) Conduct a performance test to demonstrate compliance with the applicable emission limitation in table 1 to this subpart.
(3) Establish revised operating limits according to the applicable procedures in paragraphs (a) through (e) of this section.
(g) For wet scrubbers and wet ESPs subject to performance testing in § 63.9620(l) and operating limits for scrubber water flow rate and pH in § 63.9590(b)(5), you must establish site-specific operating limits according to the procedures in paragraphs (g)(1) and (2) of this section.
(1) Using the CPMS required in § 63.9631(b), measure and record the scrubber water flow rate and pH of the scrubber water effluent every 15 minutes during each run of the performance test for hydrogen chloride and hydrogen fluoride.
(2) Calculate and record the average scrubber water flow rate and average pH of the scrubber water effluent for each individual test run. Your operating limit must be established as the average scrubber water flow rate and average pH of the scrubber water of the three test runs. If a higher average flow rate is measured during the most recent PM performance test, the operating limit for the daily average scrubber water flow rate is the average scrubber water flow rate measured during the most recent PM performance test. If a higher average flow rate is measured during the most recent HCl and HF performance test, the operating limit for the daily average scrubber water flow rate is the average scrubber water flow rate measured during the most recent HCl and HF performance test.
(h) For ACI systems subject to performance testing in § 63.9620(k)(1) and operating limits for activated carbon sorbent injection rate and carrier gas flow rate in § 63.9590(b)(6), you must establish site-specific operating limits according to the procedures in paragraphs (h)(1) and (2) of this section.
(1) Using the CPMS required in § 63.9631(b), measure and record the activated carbon injection rate and carrier gas flow rate every 15 minutes during each run of the performance test for mercury.
(2) Calculate and record the average activated carbon injection rate and carrier gas flow rate for each individual test run. Your operating limit must be established as the highest activated carbon injection rate and carrier gas flow rate of the three test runs.
(i) For DSI systems subject to performance testing in § 63.9620(l) and operating limits for sorbent injection rate and carrier gas flow rate in § 63.9590(b)(7), you must establish site-specific operating limits according to the procedures in paragraphs (i)(1) and (2) of this section.
(1) Using the CPMS required in § 63.9631(b), measure and record the sorbent injection rate and carrier gas flow rate every 15 minutes during each run of the performance test for hydrogen chloride and hydrogen fluoride.
(2) Calculate and record the average sorbent injection rate and carrier gas flow rate for each individual test run. Your operating limit must be established as the highest average sorbent injection rate and carrier gas flow rate of the three test runs.
(a) For each affected source subject to an emission limit in tables 1 through 3 to this subpart, you must demonstrate initial compliance by meeting the emission limit requirements in paragraphs (a)(1) through (8) of this section by the compliance date specified in § 63.9583.
(1) For ore crushing and handling, the flow-weighted mean concentration of particulate matter, determined according to the procedures in §§ 63.9620(a) and 63.9621(b), must not exceed the emission limits in table 1 to this subpart.
(2) For indurating furnaces, the flow-weighted mean concentration of particulate matter, determined according to the procedures in §§ 63.9620(b) and 63.9621(c), must not exceed the emission limits in table 1 to this subpart.
(3) For finished pellet handling, the flow-weighted mean concentration of particulate matter, determined according to the procedures in §§ 63.9620(c) and 63.9621(b), must not exceed the emission limits in table 1 to this subpart.
(4) For ore dryers, the flow-weighted mean concentration of particulate matter, determined according to the
(5) For indurating furnaces not using emissions averaging, the mercury emissions determined according to the procedures in §§ 63.9620(k)(1) or (2) and 63.9621(d), must not exceed the applicable emission limit in table 2 to this subpart.
(6) For indurating furnaces that comply with the mercury emissions limit using emissions averaging, the average mercury emissions determined according to the procedures in §§ 63.9620(k)(1) or (2), 63.9621(d) and 63.9634(m), must not exceed the applicable emission limit in table 2 to this subpart.
(7) For indurating furnaces that comply with the mercury emissions limit by adjusting the activated carbon injection rate based on the taconite pellet production rate, the mercury emissions determined according to the procedures in §§ 63.9620(k)(1) or (2), 63.9621(d) or (e), and 63.9634(n), must not exceed the applicable emission limit in table 2 to this subpart.
(8) For indurating furnaces, the hydrogen chloride and hydrogen fluoride emissions determined according to the procedures in §§ 63.9620(l) and 63.9621(d), must not exceed the applicable emission limit in table 3 to this subpart.
(b) For each affected source subject to an emission limit in table 1 to this subpart, you must demonstrate initial compliance by meeting the operating limit requirements in paragraphs (b)(1) through (5) of this section.
(1) For each wet scrubber subject to performance testing in § 63.9620 and operating limits for pressure drop and scrubber water flow rate in § 63.9590(b)(1), 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 § 63.9622(a).
(2) On or before January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, for each dynamic wet scrubber subject to performance testing in § 63.9620 and operating limits for scrubber water flow rate and either fan amperage or pressure drop in § 63.9590(b)(2), you have established appropriate site-specific operating limits and have a record of the scrubber water flow rate and either the fan amperage or pressure drop value, measured during the performance test in accordance with § 63.9622(b). After January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, for each dynamic wet scrubber subject to performance testing in § 63.9620 and operating limits for scrubber water flow rate and fan amperage in § 63.9590(b)(2), you have established appropriate site-specific operating limits and have a record of the scrubber water flow rate and the fan amperage value, measured during the performance test in accordance with § 63.9622(b).
(3) For each dry ESP subject to performance testing in § 63.9620 and one of the operating limits in § 63.9590(b)(3), you must meet the requirements in paragraph (b)(3)(i) or (ii) of this section.
(i) If you are subject to the operating limit for opacity in § 63.9590(b)(3)(i), you have established appropriate site-specific operating limits and have a record of the opacity measured during the performance test in accordance with § 63.9622(c)(1).
(ii) If you are subject to the operating limit for secondary voltage and secondary current in § 63.9590(b)(3)(ii), you have established appropriate site-specific operating limits and have a record of the secondary voltage and secondary current measured during the performance test in accordance with § 63.9622(c)(2).
(4) For each wet ESP subject to performance testing in § 63.9620 and operating limits for secondary voltage, water flow rate, and stack outlet temperature in § 63.9590(b)(4), you have established appropriate site-specific operating limits and have a record of the secondary voltage, water flow rate, and stack outlet temperature measured during the performance test in accordance with § 63.9622(d).
(5) For other air pollution control devices subject to performance testing in § 63.9620 and operating limits in accordance with § 63.9590(b)(8), you have submitted a site-specific monitoring plan in accordance with § 63.9631(f) and have a record of the site-specific operating limits as measured during the performance test in accordance with § 63.9622(e).
(c) Except as specified in paragraph (e) of this section, you must demonstrate initial compliance with the emission limits in tables 2 and 3 to this subpart, by meeting the operating limit requirements in paragraphs (c)(1) through (3) of this section.
(1) For each wet scrubber and wet ESP subject to performance testing in § 63.9620(k) and operating limits for scrubber water flow rate and pH in § 63.9590(b)(5), you have established appropriate site-specific operating limits and have a record of the scrubber water flow rate and pH measured during the performance test in accordance with § 63.9622(g).
(2) For each ACI subject to performance testing in § 63.9620(k) and operating limits for activated carbon injection rate and carrier gas flow rate in § 63.9590(b)(6), you have established appropriate site-specific operating limits and have a record of the activated carbon injection rate and carrier gas flow rate measured during the performance test in accordance with § 63.9622(i).(3) For each DSI subject to performance testing in § 63.9620(k) and operating limits for sorbent injection rate and carrier gas flow rate in § 63.9590(b)(7), you have established appropriate site-specific operating limit and have a record of the sorbent injection rate and carrier gas flow rate measured during the performance test in accordance with § 63.9622(h).
(d) If you elect to comply with the mercury limit in table 2 to this subpart using emissions averaging for indurating furnaces constructed or reconstructed before May 15, 2023, you must comply with the requirements in paragraphs (d)(1) through (4) of this section.
(1) Before submitting the implementation plan required in paragraph (d)(3) of this section, you must complete the mercury stack testing required in § 63.9620(k)(1) or install, calibrate, and operate a mercury CEMS pursuant to § 63.9620(k)(2) and paragraph (e) of this section for all indurating furnaces you wish to include in the mercury emission average.
(2) You must develop and submit to the applicable regulatory authority for review and approval, an implementation plan for mercury emission averaging no later than 180 days before the date you intend to demonstrate compliance using the emission averaging option. You must include the information contained in paragraphs (d)(2)(i) through (iii) of this section in your implementation plan.
(i) Identification of all indurating furnaces in the averaging group, including the typical taconite pellet production rate, control technology installed, and types of fuel(s) that will be burned.
(ii) The mercury emission rate for each furnace for each of the fuels identified in paragraph (d)(2)(i) of this section.
(iii) The date on which you are requesting emission averaging to commence.
(3) The regulatory authority shall review and approve or disapprove the plan according to the following criteria:
(i) Whether the content of the plan includes all the information specified in paragraph (d)(2) of this section, and
(ii) Whether the plan presents sufficient information to determine that compliance will be achieved and maintained.
(4) The applicable regulatory authority shall not approve an emission averaging implementation plan containing any of the following provisions:
(i) Averaging that includes indurating furnaces constructed or reconstructed on or after May 15, 2023, or
(ii) Averaging between indurating furnaces located at different facilities.
(e) If you elect to demonstrate compliance with the mercury limit in table 2 to this subpart using a mercury CEMS, you must calculate the 30-day rolling average of 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown, calculated using equation 19-19 in section 12.4.1 of EPA Reference Method 19 at appendix A-7 of 40 CFR part 60. The 1-hour arithmetic averages for CEMS must be calculated using the data points required under § 63.8(c)(4)(ii).
(f) For each emission limitation and operating limit that applies to you, you must submit a notification of compliance status according to § 63.9640(e)
(b) You must conduct subsequent performance tests on all stacks associated with indurating furnaces to demonstrate continued compliance with the indurating furnace emission limits in tables 1 through 3 to this subpart according to the schedule developed by your permitting authority and shown in your title V permit, but no less frequent than twice per 5-year permit term. If a title V permit has not been issued, you must submit a testing plan and schedule, containing the information specified in paragraph (e) of this section, to the permitting authority for approval. For an indurating furnace with multiple stacks, the performance tests for all stacks must be conducted within 7 calendar days of commencement of the performance tests, to the extent practicable, and the indurating furnace and associated control device (where applicable) operating characteristics must remain representative and consistent for the duration of the stack tests. If you determine that the performance tests cannot be completed within 7 calendar days, the Administrator must be notified within 24 hours of making that determination. Performance testing for mercury is not required for furnaces using CEMS to demonstrate compliance with the mercury emission limits in table 2 to this subpart.
(e) * * *
(2) A schedule indicating when you will conduct subsequent performance tests for particulate matter, mercury, hydrogen chloride and hydrogen fluoride for each of the emission units.
The revisions and additions read as follows:
(d) For each dry ESP subject to the operating limits in § 63.9590(b)(3), you must follow the monitoring requirements in paragraph (d)(1) or (2) of this section.
(1) If the operating limit you choose to monitor is the 6-minute average opacity of emissions in accordance with § 63.9590(b)(3)(i), you must install, operate, and maintain a COMS according to the requirements in § 63.9632(f) and monitor the 6-minute average opacity of emissions exiting each control device stack according to the requirements in § 63.9633.
(2) If the operating limit you choose to monitor is average secondary voltage and average secondary current for each dry ESP field in accordance with § 63.9590(b)(3)(ii), you must install, operate, and maintain a CPMS according to the requirements in § 63.9632(b) through (e) and monitor the daily average secondary voltage and daily average secondary current according to the requirements in § 63.9633.
(e) For each wet ESP subject to the operating limits in § 63.9590(b)(4), you must install, operate, and maintain a CPMS according to the requirements in § 63.9632(b) through (e) and monitor the daily average secondary voltage, daily average stack outlet temperature, and daily average water flow rate according to the requirements in § 63.9633.
(f) For each wet scrubber and wet ESP subject to the operating limits in § 63.9590(b)(5), you must install, operate, and maintain a CPMS according to the requirements in § 63.9632(g) and monitor the daily average scrubber water flow rate and pH of the scrubber water effluent.
(g) For each ACI system subject to the operating limits in § 63.9590(b)(6), you must install, operate, and maintain a CPMS according to the requirements in § 63.9632(h) and (i) and monitor the daily average activated carbon injection rate and carrier gas flow rate.
(h) For each DSI system subject to the operating limits in § 63.9590(b)(7), you must install, operate, and maintain a CPMS according to the requirements in § 63.9632(h) and (i) and monitor the daily average sorbent injection rate and carrier gas flow rate.
(i) If you use any air pollution control device other than a baghouse, wet scrubber, dry ESP, wet ESP, DSI, or ACI, you must submit a site-specific monitoring plan that includes the information in paragraphs (i)(1) through (4) of this section. The monitoring plan is subject to approval by the Administrator. You must maintain a current copy of the monitoring plan onsite, and it must be available for inspection upon request. You must keep the plan for the life of the affected source or until the affected source is no longer subject to the requirements of this subpart.
(1) A description of the device.
(2) Test results collected in accordance with § 63.9621 verifying the performance of the device for reducing emissions of particulate matter, mercury, hydrogen chloride, and hydrogen fluoride to the atmosphere to the levels required by this subpart.
(3) A copy of the operation and maintenance plan required in § 63.9600(b).
(4) Appropriate operating parameters that will be monitored to maintain continuous compliance with the applicable emission limitation(s).
(j) If you elect to comply with the mercury limit in table 2 to this subpart using emissions averaging in accordance with an implementation plan approved under the provisions in § 63.9623(d) or you elect to adjust the activated carbon injection rate based on the taconite pellet production rate in accordance with the procedures in § 63.9634(n), you must determine and record the mass of taconite pellets produced each month by each furnace included in the emissions averaging group. The weight of taconite pellets produced must be determined by measurement using weigh hoppers, belt weigh feeders, or weighed quantities in shipments, or calculated using the bulk density and volume measurements.
(k) If you elect to demonstrate compliance with the mercury emissions limits in table 2 to this subpart using a CEMS to measure mercury emissions, you must comply with the requirements in (k)(1) through (5).
(1) Notify the Administrator one month before starting use of the CEMS and notify the Administrator 180-days before ceasing use of the CEMS.
(2) Each CEMS must be installed, certified, calibrated, and maintained according to the requirements of performance specifications 6 and 12A of 40 CFR part 60, appendix B, and quality assurance procedure 6 of 40 CFR part 60, appendix F.
(3) Operate the mercury CEMS in accordance with performance specification 12A of 40 CFR part 60, appendix B. The duration of the performance test must be 30 operating days. For each day in which the unit operates, you must obtain hourly mercury concentration data, and stack gas volumetric flow rate data.
(4) You must complete the initial performance evaluation of the CEMS within 180 days after notifying the Administrator and before starting to use the CEMS data in lieu of performance testing and monitoring operating parameters to demonstrate compliance.
(5) Collect CEMS hourly averages for all operating hours on a 30-day rolling average basis. The one-hour arithmetic averages, expressed in units of lb/LT, must be used to calculate 30-day rolling average emissions to determine compliance with the applicable emission limit in table 2 to this subpart.
The revisions and additions read as follows:
(f) For each dry ESP subject to the opacity operating limit in § 63.9590(b)(3)(i), you must install, operate, and maintain each COMS according to the requirements in paragraphs (f)(1) through (4) of this section.
(2) On or before January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, you must develop and implement a quality control program for operating and maintaining each COMS according to § 63.8. At a minimum, the quality control program must include a daily calibration drift assessment, quarterly performance audit, and annual zero alignment of each COMS. After January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, you must develop and implement a quality control program for operating and maintaining each COMS according to § 63.8(a) and (b), (c)(1)(ii), (c)(2) through (8), (d)(1) and (2), and (e) through (g) and Procedure 3 in appendix F to 40 CFR part 60. At a minimum, the quality control program must include a daily calibration drift assessment, quarterly performance audit, and annual zero alignment of each COMS.
(g) For each pH measurement device, in addition to the requirements in paragraphs (b) through (e) of this section, you must meet the requirements in paragraphs (g)(1) through (4) of this section.
(1) The minimum accuracy of the pH measurement device must be ±0.2 pH units.
(2) Locate the pH sensor in a position that provides a representative measurement of scrubber effluent pH.
(3) Ensure the sample is properly mixed and representative of the fluid to be measured.
(4) Check the pH meter's calibration on at least two points every 8 hours of process operation.
(h) For each mass flow rate monitor used for measuring the sorbent or activated carbon injection rate, in addition to the requirements in paragraphs (b) through (e) of this section, you must meet the requirements of (h)(1) through (4) of this section.
(1) The minimum accuracy of the mass flow rate monitor must be ±5 percent over the normal range of flow measured.
(2) Locate the device in a position(s) that provides a representative measurement of the total sorbent injection rate.
(3) Install and calibrate the device in accordance with manufacturer's procedures and specifications.
(4) At least annually, conduct a performance evaluation of the injection rate monitoring system in accordance with your monitoring plan.
(i) For each carrier gas flow rate monitor, in addition to the requirements in paragraphs (b) through (e) of this section, you must meet the requirements of (i)(1) through (4) of this section.
(1) The minimum accuracy of the gas flow rate monitor must be ±5 percent over the normal range of flow measured or 280 liters per minute (10 cubic feet per minute), whichever is greater.
(2) Locate the device in a position(s) that provides a representative measurement of the carrier gas flow rate.
(3) Install and calibrate the device in accordance with manufacturer's procedures and specifications.
(4) At least annually, conduct a performance evaluation of the carrier gas flow rate monitoring system in accordance with your monitoring plan.
(a) For each affected source subject to an emission limit in table 1 to this subpart, you must demonstrate continuous compliance by meeting the requirements in paragraphs (b) through (h) of this section.
(e) * * *
(4) If the daily average pressure drop or daily average scrubber water flow rate is below the operating limits established for a corresponding emission unit or group of similar emission units, you must then follow the corrective action procedures in paragraph (l) of this section.
(f) * * *
(4) On or before January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, if the daily average scrubber water flow rate, daily average fan amperage, or daily average pressure drop is below the operating limits established for a corresponding emission unit or group of similar emission units, you must then follow the corrective action procedures in paragraph (l) of this section. After January 28, 2022, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, if the daily average scrubber water flow rate or daily average fan amperage, is below the operating limits established for a corresponding emission unit or group of similar emission units, you must then follow the corrective action procedures in paragraph (l) of this section.
(g) For each dry ESP subject to operating limits in § 63.9590(b)(3), you
(1) If the operating limit for your dry ESP is a 6-minute average opacity of emissions value, then you must follow the requirements in paragraphs (g)(1)(i) through (iii) of this section.
(i) Maintaining the 6-minute average opacity of emissions at or below the maximum level established during the initial or subsequent performance test.
(ii) Operating and maintaining each COMS and reducing the COMS data according to § 63.9632(f).
(iii) If the 6-minute average opacity of emissions is above the operating limits established for a corresponding emission unit, you must then follow the corrective action procedures in paragraph (l) of this section.
(2) If the operating limit for your dry ESP is the daily average secondary voltage and daily average secondary current for each field, then you must follow the requirements in paragraphs (g)(2)(i) through (iv) of this section.
(i) Maintaining the daily average secondary voltage or daily average secondary current for each field at or above the minimum levels established during the initial or subsequent performance test.
(ii) Operating and maintaining each dry ESP CPMS according to § 63.9632(b) and recording all information needed to document conformance with these requirements.
(iii) Collecting and reducing monitoring data for secondary voltage or secondary current for each field according to § 63.9632(c) and recording all information needed to document conformance with these requirements.
(iv) If the daily average secondary voltage or daily average secondary current for each field is below the operating limits established for a corresponding emission unit, you must then follow the corrective action procedures in paragraph (l) of this section.
(h) For each wet ESP subject to the operating limits for secondary voltage, stack outlet temperature, and water flow rate in § 63.9590(b)(4), you must demonstrate continuous compliance by completing the requirements of paragraphs (h)(1) through (4) of this section.
(1) Maintaining the daily average secondary voltage and daily average scrubber water flow rate for each field at or above the minimum levels established during the initial or subsequent performance test. Maintaining the daily average stack outlet temperature at or below the maximum levels established during the initial or subsequent performance test.
(2) Operating and maintaining each wet ESP CPMS according to § 63.9632(b) and recording all information needed to document conformance with these requirements.
(3) Collecting and reducing monitoring data for secondary voltage, stack outlet temperature, and water flow rate according to § 63.9632(c) and recording all information needed to document conformance with these requirements.
(4) If the daily average secondary voltage, stack outlet temperature, or water flow rate does not meet the operating limits established for a corresponding emission unit, you must then follow the corrective action procedures in paragraph (l) of this section.
(i) For each affected indurating furnace subject to a hydrogen chloride and hydrogen fluoride emission limit in table 3 to this subpart, you must demonstrate continuous compliance by meeting the requirements in paragraphs (i)(1) and (2) of this section.
(1) For each wet scrubber and wet ESP subject to the operating limits for scrubber water flow rate and pH in § 63.9590(b)(5), you must demonstrate continuous compliance by completing the requirements of paragraphs (i)(1)(i) through (iv) of this section.
(i) Maintaining the daily average scrubber water flow rate and daily average pH of the scrubber water effluent at or above the minimum level established during the most recent performance test. If a higher average flow rate is measured during the last PM performance test, the operating limit for daily average scrubber water flow rate is the highest average scrubber water flow rate measured during the last PM performance test.
(ii) Operating and maintaining each of the CPMS used to measure scrubber water flow rate and pH according to § 63.9632(g) and recording all information needed to document conformance with these requirements.
(iii) Collecting and reducing monitoring data for scrubber water flow rate and pH according to § 63.9632(c) and recording all information needed to document conformance with these requirements.
(iv) If the daily average scrubber water flow rate or daily average pH is below the operating limits established for control device, you must follow the corrective action procedures in paragraph (l) of this section.
(2) For each DSI subject to the operating limits for sorbent injection rate and carrier gas flow rate in § 63.9590(b)(7), you must demonstrate continuous compliance by completing the requirements of paragraphs (i)(2)(i) through (iv) of this section.
(i) Maintain the daily average sorbent injection rate and carrier gas flow rate at or above the minimum level established during the most recent performance test.
(ii) Operate and maintain each CPMS used to measure the sorbent injection rate according to § 63.9632(h) and the carrier gas flow rate according to § 63.9632(i) and recording all information needed to document compliance with these requirements.
(iii) Collect and reduce monitoring data for the sorbent injection rate and carrier gas flow rate according to § 63.9632(c) and recording all information needed to document compliance with these requirements.
(iv) If the daily average the sorbent injection rate or carrier gas flow rate is below the operating limit established for the control device, you must follow the corrective action procedures in paragraph (l) of this section.
(j) For each affected indurating furnace using ACI to comply with the mercury emission limit in table 2 to this subpart, you must demonstrate continuous compliance by meeting the requirements of paragraphs (j)(1) or (2) of this section.
(1) If you use CEMS to demonstrate compliance, you must comply with the requirements in paragraphs (j)(1)(i) and (ii) of this section.
(i) You must operate a mercury CEMS in accordance with performance specification 12A at 40 CFR part 60, appendix B; these monitoring systems must be quality assured according to procedure 5 of 40 CFR 60, appendix F. You must demonstrate compliance with the mercury emissions limit using a 30-day rolling average of these 1-hour mercury concentrations or mass emissions rates, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19-19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A-7 of this part.
(ii) Owners or operators using a mercury CEMS to determine mass emission rate must install, operate, calibrate and maintain an instrument for continuously measuring and recording the mercury mass emissions rate to the atmosphere according to the requirements of performance specification 6 at 40 CFR part 60, appendix B and conducting an annual relative accuracy test of the continuous emission rate monitoring system according to section 8.2 of performance specification 6.
(2) If you do not use CEMS to demonstrate compliance, you must demonstrate continuous compliance by meeting the requirements of paragraphs (j)(2)(i) through (iv) of this section.
(i) Maintain the daily average activated carbon injection rate and carrier gas flow rate at or above the minimum level established during the most recent performance test.
(ii) Operate and maintain each CPMS used to measure the activated carbon injection rate according to § 63.9632(h) and the carrier gas flow rate according to § 63.9632(i), and record all information needed to document compliance with these requirements.
(iii) Collect and reduce monitoring data for the activated carbon injection rate and carrier gas flow rate according to § 63.9632(c) and record all information needed to document conformance with these requirements.
(iv) If the daily average of the activated carbon injection rate or carrier gas flow rate is below the operating limit established for the control device, you must follow the corrective action procedures in paragraph (l) of this section.
(k) If you use an air pollution control device other than a wet scrubber, dynamic wet scrubber, dry ESP, wet ESP, DSI, ACI, or baghouse, you must submit a site-specific monitoring plan in accordance with § 63.9631(f). The site-specific monitoring plan must include the site-specific procedures for demonstrating initial and continuous compliance with the corresponding operating limits.
(l) If the daily average operating parameter value for an emission unit or group of similar emission units does not meet the corresponding established operating limit, you must then follow the procedures in paragraphs (l)(1) through (4) of this section.
(1) You must initiate and complete initial corrective action within 10 calendar days and demonstrate that the initial corrective action was successful. During any period of corrective action, you must continue to monitor, and record all required operating parameters for equipment that remains in operation. After the initial corrective action, if the daily average operating parameter value for the emission unit or group of similar emission units meets the operating limit established for the corresponding unit or group, then the corrective action was successful and the emission unit or group of similar emission units is in compliance with the established operating limits.
(2) If the initial corrective action required in paragraph (l)(1) of this section was not successful, then you must complete additional corrective action within 10 calendar days and demonstrate that the subsequent corrective action was successful. During any period of corrective action, you must continue to monitor, and record all required operating parameters for equipment that remains in operation. If the daily average operating parameter value for the emission unit or group of similar emission units meets the operating limit established for the corresponding unit or group, then the corrective action was successful, and the emission unit or group of similar emission units is in compliance with the established operating limits.
(3) If the second attempt at corrective action required in paragraph (l)(2) of this section was not successful, then you must repeat the procedures of paragraph (l)(2) of this section until the corrective action is successful. If the third attempt at corrective action is unsuccessful, you must conduct another performance test in accordance with the procedures in § 63.9622(f) and report to the Administrator as a deviation the third unsuccessful attempt at corrective action.
(4) After the third unsuccessful attempt at corrective action, you must submit to the Administrator the written report required in paragraph (l)(3) of this section within 5 calendar days after the third unsuccessful attempt at corrective action. This report must notify the Administrator that a deviation has occurred and document the types of corrective measures taken to address the problem that resulted in the deviation of established operating parameters and the resulting operating limits.
(m) If you elect to comply with the mercury limit in table 2 to this subpart using emissions averaging in accordance with an implementation plan approved under the provisions in § 63.9623(d), you must comply with the requirements in paragraphs (m)(1) through (5) of this section.
(1) For furnaces included in the emissions averaging group that do not use mercury CEMS, you must comply with the requirements in paragraph (m)(1)(i) or (ii) as applicable.
(i) For furnaces equipped with ACI systems, you must comply with the requirements in paragraph (j) of this section.
(ii) For furnaces equipped with a mercury control device or method other than ACI, you must comply with your site-specific monitoring plan in accordance with the requirements in paragraph (k) of this section.
(2) For furnaces included in the emissions averaging group that use mercury CEMS, you must comply with the requirements in paragraph (i)(1) of this section.
(3) Calculate the monthly production-weighted average emission rate using either the mercury CEMS data or mercury emission rate determined during the last performance test and the actual taconite pellet production data for each furnace included in the emissions averaging option, as shown in Equation 6 of this section.
(4) Until 12 monthly weighted average emission rates have been accumulated, the monthly weighted average emissions rate, calculated as shown in paragraph (m)(3) of this section, must not exceed the mercury emission limit in table 3 of this subpart in any calendar month.
(5) After 12 monthly weighted average emission rates have been accumulated, for each subsequent calendar month, you must use Equation 7 of this section to calculate the 12-month rolling average of the monthly weighted average emission rates for the current month and the previous 11 months. The 12-month rolling weighted average emissions rate for the furnaces included in the group must not exceed the mercury emission limit in table 3 of this subpart.
(n) You may elect to demonstrate continuous compliance with the mercury limit in table 2 to this subpart by adjusting the activated carbon injection rate based on the taconite pellet production rate. You must comply with the requirements in
(1) Measure the activated carbon injection and mercury emissions rate at a minimum of three different production levels corresponding to the maximum, minimum and median finished taconite pellet production rates, using the methods specified in § 63.9620(k).
(2) Develop a correlation curve by plotting the production rate and corresponding carbon injection rate for the maximum, median and minimum production rates. Use only data where the mercury emission rate is below the applicable mercury emissions standard in table 2 to this subpart. Plot the production rates as the independent (or x) variable and the activated carbon injection rate as the dependent (or y) variable for each pellet production rate. Construct the graph by drawing straight line segments between each point plotted.
(3) You must develop and submit to the applicable regulatory authority for review and approval, an implementation plan no later than 180 days before the date you intend to demonstrate compliance by adjusting the activated carbon injection rate based on the taconite pellet production. You must include the information listed in paragraphs (n)(3)(i) through (iv) of this section in your implementation plan.
(i) Identification of the indurating furnace, including the typical maximum and minimum taconite pellet production rate, mercury control technology installed, and types of fuel(s) that will be burned.
(ii) The mercury emissions and activated carbon injection rates at maximum, median and minimum taconite pellet production rates, and the methods used to measure the mercury emissions, activated carbon injection rate and taconite pellet production.
(iii) The correlation curve developed in paragraph (n)(2) of this section.
(iv) The date on which you are requesting to commence adjusting the activated carbon rate based on the taconite production rate.
(4) Install, calibrate, maintain, and operate a CPMS to monitor and record the activated carbon injection rate and taconite pellet production rate.
(5) Maintain the carbon injection rate at or above the rate established by the correlation curve corresponding to the taconite pellet production rate. If the taconite pellet production rate drops below the minimum rate established in paragraph (n)(3) of this section, you must maintain the activated carbon injection rate at or above the rate established for the minimum taconite pellet production rate.
(6) Keep records of the activated carbon injection rate and taconite pellet production rate for each hour of operation in order to demonstrate that the activated carbon injection rate remains in compliance with paragraph (n)(5) of this section.
(7) Establish a new correlation curve at least twice per 5-year permit term.
(a) For each control device used to comply with an emission standard in § 63.9590(a), you must demonstrate continuous compliance with the operation and maintenance requirements in § 63.9600(b) by completing the requirements of paragraphs (a)(1) through (4) of this section.
(a)
(f) If you elect to use CEMS to demonstrate compliance with the mercury standards in table 2 to this subpart, you must submit a notification of intent to use CEMS at least one month prior to making the change. If you are currently using CEMS to demonstrate compliance with the mercury standards, you must submit a notification of intent to cease using CEMS to demonstrate compliance at least 180 days prior to making the change.
(g) If you elect to use the mercury emissions averaging compliance option, you must submit a notification of intent at least 180 days prior to making the change. If you are currently using the mercury emissions averaging compliance option, you must submit a notification of intent to cease using emissions averaging at least 30 days prior to making the change.
The revisions and additions read as follows:
(b) * * *
(6) If there were no periods during which a continuous monitoring system (including a CPMS, COMS, or CEMS) was out-of-control as specified in § 63.8(c)(7), then provide a statement that there were no periods during which a continuous monitoring system was out-of-control during the reporting period.
(8) On or before January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, for each deviation from an emission limitation occurring at an affected source where you are using a continuous monitoring system (including a CPMS or COMS) to comply with the emission limitation in this subpart, you must include the information in paragraphs (b)(1) through (4) of this section and the information in paragraphs (b)(8)(i) through (xi) of this section. This includes periods of startup, shutdown, and malfunction. After January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, for each deviation from an emission limitation occurring at an affected source where you are using a continuous monitoring system (including a CPMS, COMS, or CEMS) to comply with the emission limitation in this subpart, you must include the information in paragraphs (b)(1) through
(i) The date and time that each malfunction started and stopped.
(ii) The start date, start time, and duration in hours (or minutes for COMS) that each continuous monitoring system was inoperative, except for zero (low-level) and high-level checks.
(iii) The start date, start time, and duration that each continuous monitoring system was out-of-control, including the information in § 63.8(c)(8).
(iv) On or before January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, for each affected source or equipment, the date and time that each deviation started and stopped, the cause of the deviation, and whether each deviation occurred during a period of startup, shutdown, or malfunction or during another period. After January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, for each affected source or equipment, the date and time that each deviation started and stopped, the cause of the deviation, and whether each deviation occurred during a period of malfunction or during another period
(v) The total duration of all deviations for each Continuous Monitoring System (CMS) during the reporting period, the total operating time in hours of the affected source during the reporting period, and the total duration as a percent of the total source operating time during that reporting period.
(vi) On or before January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, a breakdown of the total duration of the deviations during the reporting period including those that are due to startup, shutdown, control equipment problems, process problems, other known causes, and other unknown causes. After January 25, 2021, for affected sources that commenced construction or reconstruction on or before September 25, 2019, and after July 28, 2020, or upon start-up, which ever date is later, for affected sources that commenced construction or reconstruction after September 25, 2019, a breakdown of the total duration of the deviations during the reporting period including those that are due to control equipment problems, process problems, other known causes, and other unknown causes.
(vii) The total duration of continuous monitoring system downtime for each continuous monitoring system during the reporting period, the total operating time in hours of the affected source 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) A brief description of the process units.
(ix) The monitoring equipment manufacturer and model number and the pollutant or parameter monitored.
(x) The date of the latest continuous monitoring system certification or audit.
(xi) A description of any changes in continuous monitoring systems, processes, or controls since the last reporting period.
(c)
(1) 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
(2) If you cannot transmit the file electronically, you may send CBI information through the postal service to the following address: U.S. EPA, Attn: OAQPS Document Control Officer and Taconite Iron Ore Processing Sector Lead, Mail Drop: C404-02, 109 T.W. Alexander Drive, P.O. Box 12055, RTP, NC 27711. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.
(e)
(f) * * *
(3)
(i) 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)(1) or (2) of this section, you must submit a complete file, including information claimed to be CBI, to the EPA.
(ii) 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.
(iii) 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.
(iv) 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
(v) If you cannot transmit the file electronically, you may send CBI information through the postal service to the following address: U.S. EPA, Attn: OAQPS Document Control Officer and Measurement Policy Group Lead, Mail Drop: C404-02, 109 T.W. Alexander Drive, P.O. Box 12055, RTP, NC 27711. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.
(vi) 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.
(vii) 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 § 63.9(k).
(i)
(1) For performance evaluations of continuous monitoring systems measuring relative accuracy test audit (RATA) pollutants that are supported by the EPA's ERT as listed on the EPA's ERT website at the time of the evaluation, you must submit the results of the performance evaluation to the EPA via the CEDRI. Performance evaluation data must be submitted in a file format generated through the use of the EPA's ERT or an alternate file format consistent with the XML schema listed on the EPA's ERT website. If you claim that some of the performance evaluation information being transmitted is CBI, you must submit a complete file generated through the use of the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website, including information claimed to be CBI, on a compact disc, flash drive, or other commonly used electronic storage media to the EPA. The electronic media must be clearly marked as CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404-02, 4930 Old Page Rd., Durham, NC 27703. The same ERT or alternate file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described earlier in this section.
(2) For any performance evaluations of continuous monitoring systems measuring RATA pollutants that are not supported by the EPA's ERT as listed on the ERT website at the time of the evaluation, you must submit the results of the performance evaluation to the Administrator at the appropriate address listed in § 63.13.
The revisions and additions read as follows:
(b) For each COMS and CEMS, you must keep the records specified in paragraphs (b)(1) through (5) of this section.
(5) If you use mercury CEMS to demonstrate compliance with the mercury emission standard in table 2 of the subpart in accordance with § 63.9623(e), records of requests for alternatives to the relative accuracy test for CEMS as required in § 63.8(f)(6)(i).
(d) If you elect the mercury emissions averaging compliance alternative pursuant to § 63.9623(d), you must keep a copy of the emission averaging implementation plan required in § 63.9623(d)(2), records of the taconite pellet production rate for each furnace included in the averaging, and all calculations required under § 63.9634(m).
(e) If you elect to adjust the activated carbon injection rate based on the taconite pellet production rate in accordance with the provisions in § 63.9634(n), you must keep a copy of the activated carbon injection implementation plan and records of the taconite pellet production rate and activated carbon injection rate.
(f) If you use CEMS to demonstrate compliance with the mercury emissions limits in table 2 to this subpart, you must keep records of the notifications required in § 63.9642(f).
Table 4 to this subpart shows which parts of the General Provisions in §§ 63.1 through 63.16 apply to you.
As required in § 63.9590(a), you must comply with each applicable particulate matter emission limit in the following table: