Agricultural Marketing Service
Agricultural Research Service
Farm Service Agency
National Agricultural Library
Rural Business-Cooperative Service
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
Surface Mining Reclamation and Enforcement Office
Drug Enforcement Administration
Federal Aviation Administration
Federal Railroad Administration
Maritime Administration
Pipeline and Hazardous Materials Safety Administration
Financial Crimes Enforcement Network
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Agricultural Marketing Service, USDA.
2025 sunset review and substance renewals.
This document announces the renewal of 47 substances listed on the National List of Allowed and Prohibited Substances within the U.S. Department of Agriculture's organic regulations. This document reflects the outcome of the 2025 sunset review processes and addresses recommendations submitted to the Secretary of Agriculture, through the USDA's Agricultural Marketing Service, by the National Organic Standards Board.
Applicable June 22, 2025.
Jared Clark, National List Manager, Standards Division, National Organic Program, Phone: (202) 720-3252; Email:
On December 21, 2000, the Secretary established the Agricultural Marketing Service's (AMS) National Organic Program (NOP) and the USDA organic regulations (65 FR 80548, December 21, 2000). Within the USDA organic regulations (7 CFR part 205) is the National List of Allowed and Prohibited Substances (or “National List”). The National List identifies the synthetic substances that may be used and the nonsynthetic (natural) substances that may not be used in organic crop and livestock production. It also identifies the nonorganic substances that may be used in or on processed organic products.
The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. chapter 94), and the USDA organic regulations specifically prohibit the use of any synthetic substance in organic production and handling unless the synthetic substance is on the National List (7 CFR 205.601, 205.603 and 205.605(b)). Section 205.105 also requires that any nonorganic agricultural substance and any nonsynthetic nonagricultural substance used in organic handling be on the National List (§§ 205.605(a) and 205.606).
The OFPA at 7 U.S.C. 6518 authorizes the National Organic Standards Board (“NOSB” or “Board”), operating in accordance with the Federal Advisory Committee Act (section 1
As required by the OFPA, during a sunset review, the NOSB considers any new information about a substance's impact on human health and the environment, its necessity, and its consistency with organic production and handling. The NOSB then votes on proposals to remove individual substances from the National List, with a
As delegated by the Secretary, AMS evaluates the NOSB's reviews and recommendations for compliance with the National List substance evaluation criteria in the OFPA at 7 U.S.C. 6518(m) and other federal statutes or regulations. AMS also considers public comments submitted in association with the sunset review process, as described in the notice published on September 16, 2013 (78 FR 56811).
AMS published notices in the
AMS has reviewed and accepted all NOSB sunset review recommendations for substances with sunset dates in 2025. AMS is renewing the listings of these substances until 2030. AMS determined that the substance allowances listed in this notice are still necessary because of the unavailability of organic forms or wholly natural substitutes for the specified uses (7 U.S.C. 6517(c)(1)(A)(ii)). The renewal of these substances will avoid potential disruptions to the organic industry that may otherwise result from removal from the National List. AMS also has determined that the prohibited natural substances listed in this notice should remain prohibited because their use remains inconsistent with organic production (7 U.S.C. 6517(c)(2)(A)(ii)).
This document renews 46 of the 47 substances in this notice for another 5 years past their existing sunset date of June 22, 2025.
One of the forty-seven substances renewed in this notice currently has an existing sunset date of December 7, 2025. This notice renews tamarind seed gum another 4 years and 6-1/2 months past its existing sunset date of December 7, 2025, to establish a new sunset date for this substance that matches the sunset dates of the other substances renewed in this notice.
This document establishes a new sunset date for the following substances as outlined in the header for table 1.
7 U.S.C. chapter 94.
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects a final rule published by the FAA in the
Effective date 0901 UTC, September 5, 2024. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Brian Vidis, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a final rule in the
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Kentucky regulatory program (hereinafter, the Kentucky program), under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). We are approving Kentucky's revision to its regulations regarding the qualifications of members of the Kentucky Reclamation Guaranty Fund Commission.
The effective date is September 9, 2024.
Mr. Michael Castle, Field Office Director, Telephone 859-260-3900, Email:
Subject to OSMRE's oversight, section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations.
On July 18, 1986, we approved the creation of Kentucky's bond pool commission, which from 1986 to 2013 oversaw Kentucky's initial alternative bonding system known as the voluntary bond pool fund. 51 FR 26002 (July 18, 1986). In May 2012, we concluded that the State regulatory authority was not effectively implementing, administering, enforcing, and maintaining its reclamation bond program, and we initiated the regulatory process to correct the identified regulatory program issues.
By letter dated April 18, 2022 (Administrative Record No. KY-2008), Kentucky sent us an amendment to its program under SMCRA (30 U.S.C. 1201
We announced receipt of the proposed amendment in the May 23, 2023,
We made the following findings concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below. The full text of this program amendment is available at
We are approving the following changes to KRS 350.506:
We asked for public comments on the amendment and received two. The first was from a private citizen recommending the qualifications of the board members to consist of only scientists studying fossil fuel consumption and its effects. As we discussed above, should a State elect to establish an alternative bonding system, its means of implementing the alternative bonding system is at the State's discretion so long as it complies with the general requirements of section 509 of SMCRA and 30 CFR 800.11(e). Therefore, the specific qualifications of the KRGFC members are beyond the scope of this rulemaking.
The second public comment was from the Kentucky Resources Council, Inc. (Council). The Council agrees that the proposed revisions to the commission membership qualifications are acceptable in efforts to support changing coal industry demographics. Further, the Council recommends that an annual review of the Kentucky Permanent Regulatory Program, which would include the assurance of adequate funding in the event of bond forfeiture or permittee bankruptcy, fall under OSMRE's oversight function. Oversight of Kentucky's bonding program has always been and will continue to be one of our responsibilities.
On July 13, 2022, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various agencies with an actual or potential interest in the Kentucky program (Administrative Record KY-2008-1). The Natural Resources Conservation Service sent a “no comment letter”; and we did not receive any comments from other agencies.
Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On July 13, 2022, we requested comments on the Kentucky amendments (Administrative Record No. KY-2008-1). We did not receive comments from the SHPO or ACHP.
Based on the above findings, we are approving KY-264 submitted to us on April 18, 2022 (Administrative Record No. KY-2008). To implement this decision, we are amending the Federal regulations at 30 CFR part 917 that codify decisions concerning the Kentucky program. In accordance with the Administrative Procedure Act (5 U.S.C. 533), this rule will take effect 30 days after the date of publication.
This rule would not effect a taking of private property or otherwise have taking implications that would result in private property being taken for government use without just compensation under the law. Therefore, a taking implication assessment is not required. This determination is based on an analysis of the Federal regulations that set minimum performance standards for alternative bonding systems.
Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance dated October 12, 1993 (OMB Memo M-94-3), the approval of State program amendments are exempted from OMB review under Executive Order 12866, as amended by Executive Order 14094. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.
The Department of the Interior has reviewed this rule as required by section 3 of Executive Order 12988. The Department determined that this
This rule has potential Federalism implications as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. Kentucky, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the state level. This rule approves an amendment to the Kentucky program submitted and drafted by the State, and thus is consistent with the direction to provide maximum administrative discretion to States.
The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal Government and Tribes. The basis for this determination is that our decision on the Kentucky program does not include Indian lands as defined by SMCRA or other Tribal lands and it does not affect the regulation of activities on Indian lands or other Tribal lands. Indian lands under SMCRA are regulated independently under the applicable approved Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with minable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.
Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.
Consistent with sections 501(a) and 72(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).
This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.
This rule does not impose an unfunded mandate on State, local or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the Federal regulations that set minimum performance standards for alternative bonding systems, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 917 is amended as follows:
30 U.S.C. 1201
(a) * * *
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Pennsylvania regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The amendment authorizes and implements a land reclamation financial guarantee program as a new alternative bonding option for operators that meet certain requirements. The amendment also authorizes and implements a bioenergy crop bonding program to provide financial guarantees to remining operators that grow bioenergy crops as a postmining land use. Finally, the amendment standardizes certain terms and corrects citations in statutory and regulatory provisions affected by the addition of a new section to the Pennsylvania regulatory program or changed for other reasons.
This rule is effective September 9, 2024.
Mr. Ben Owens, Acting Field Office Director, Pittsburgh Field Office, Office of Surface Mining Reclamation and Enforcement, 3 Parkway Center, Pittsburgh, PA 15220, Telephone: (412) 937-2827, Email:
Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its approved State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations.
By letter dated July 26, 2017 (Administrative Record No. PA 900.00), the Pennsylvania Department of Environmental Protection (PADEP) sent us an amendment to its program under SMCRA (30 U.S.C. 1201
Pennsylvania adopted an amendment to PASMCRA (52 P.S. 1396.1-1396.19b), Act 95, entitled Mining Permit and Bioenergy Crop Bonding, on July 5, 2012, Public Law 918, No. 95, and designated it as becoming effective on September 3, 2012 (pending OSMRE approval). In addition to standardizing references to “department” and “secretary” throughout PASMCRA, Act 95 amended section 4(a) to “encourage and promote” the use of bioenergy crops for revegetation during reclamation of remined lands.
Pennsylvania adopted an amendment to PASMCRA (52 P.S. 1396.1-1396.19b), Act 157, entitled Mining Permit, Reclamation Plan, and Bond and Land Reclamation Financial Guarantees, on October 24, 2012, Public Law 1276, No. 157, and designated it as becoming effective on December 23, 2012 (pending OSMRE approval). Act 157 amended section 4 of PASMCRA and added section 19.2 (52 P.S. 1396.19b). In conjunction, these provisions authorize and direct PADEP to establish a program to provide “land reclamation financial guarantees” (LRFGs) to qualified operators to ensure reclamation of certain mining lands. An LRFG is a form of bond or collateral that may be available to qualified surface coal mining operators engaged in surface mining activities. Pennsylvania provides the financial guarantee to qualified operators to satisfy, in part, the required bond obligation.
The LRFG program provides for the assessment and collection of premiums from operators for such guarantees in an amount sufficient to assure the financial stability of the financial guarantee program and to cover Pennsylvania's cost to administer the program. This program replaces Pennsylvania's Conversion Assistance Program (CAP) of 2001. The CAP was a temporary program intended to assist existing mine operations in transitioning to Pennsylvania's newly established full cost bonding requirements. The statutory provisions address site and operator eligibility, establish an account for a new program in the Surface Mining Conservation and Reclamation Fund (referred to as the LRFG Account), and
On April 21, 2015, the Pennsylvania Environmental Quality Board adopted changes to mining regulations in title 25 of the Pennsylvania Code, changes that were designated as becoming effective on August 22, 2015. In particular, the Board adopted sections 86.162b and 86.162c and made various amendments to chapters 77, 86 to 90, and 211. The additional sections in chapter 86 implemented the statutory changes in Act 95 and Act 157. The amendments in chapters 77, 86 to 90, and 211 also corrected citations affected by addition of section 19.2 to PASMCRA, corrected additional citations changed for other reasons, and made other non-substantive changes.
We announced receipt of the proposed amendment in the April 3, 2019,
We are approving the amendment to the Pennsylvania regulatory program under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, as described in our findings below. The full text of the amendment is available at
Pennsylvania, through Act 157, revised section 4(d) of PASMCRA to add LRFGs to the list of available forms of reclamation bond set out in section 4(d). The revised provision requires that LRFGs be consistent with section 19.2 of PASMCRA and regulations implementing the LRFG program, which are described in
Pennsylvania, through Act 157, added section 19.2 to PASMCRA.
As discussed in
This program replaces the CAP, which replaced a predecessor program (alternative bonding system) in 2001, a change that was accompanied by “conversion” of all surface coal mine sites to full-cost bonding. The CAP program was created to serve as a bridge to the new full-cost bonding program. Section 19.2 replaces the CAP through terms that address site and operator eligibility, establishment of an account for the financial guarantees (specifically, the LRFG Account), transfer of funds from the CAP program to the LRFG Account, and transfer of funds from the LRFG Account into either the Remining Financial Assurance Fund or the Trust Account. In addition, these provisions address allocation of interest earned in the account, conditions for dissolution of the program, and management of the account.
Pennsylvania's implementing regulations include several provisions intended to assure financial solvency, as discussed below. In addition, subsection 19.2(b)(1) directs Pennsylvania to assess and collect premiums annually from operators who choose to obtain the financial guarantees. This subsection also directs Pennsylvania to establish, by regulation, an annual premium amount sufficient to assure the stability of the fund. Subsection 19.2(b)(3)(i) adds to the overall solvency of the account by transferring funds from the previous financial guarantee program (the CAP), and subsection 19.2(b)(7) authorizes the appropriation of up to $2 million annually to supplement the program.
Pennsylvania also proposes to limit solvency risk by screening potential financial guarantee recipients according to the provisions in subsection 19.2(c), including site conditions, operator financial stability, operator compliance history, and the availability of coal reserves at the site. Pennsylvania proposes to track and respond to the changing financial outlook of the account through regulations establishing underwriting methods for insuring the account against declared forfeitures, subsection 19.2(d)(2), and by allowing the guarantee program to cease immediately if 25 percent or more of the outstanding bond amounts in the program are declared forfeit, subsection 19.2(e)(1). These measures, along with further limitations described in the amendment's implementing regulations at 25 Pa. Code 86.162b (discussed and approved in
For these reasons, we have determined the LRFG program proposed in section 19.2 is no less stringent than SMCRA and no less effective than the applicable Federal regulations. Accordingly, we are approving section 19.2 of PASMCRA.
Pennsylvania revised this subsection of chapter 86 of its administrative code to add additional reporting requirements to the annual fiscal-year report to the legislature on the revenue and expenditures of the Reclamation Fee Operation and Maintenance Trust Account. In addition to items previously required when the Trust Account was originally established under 25 Pa. Code 86.17 and 86.187, information about the need for supplemental funding would now be required in the annual report. The revised subsection also requires PADEP to provide an estimate of the per-acre charge to be assessed in the next calendar year on operators seeking permits. This one-time reclamation fee is paid by operators and credited to the Trust Account. PADEP calculates the per-acre fee based on projected revenues and expenditures for the upcoming year.
Pennsylvania added this section to chapter 86 to detail implementation of the LRFG program and a financial account to facilitate administration of these guarantees. The LRFG Account is a financial instrument used to underwrite LFRGs and financially assure qualified operators of their bonding obligations. The LFRG Account also serves to fund bioenergy crop bonding as authorized in section 86.162c (see
Section 86.162b imposes several limits on Pennsylvania in issuing financial guarantees; it converts existing financial guarantees previously issued by Pennsylvania into LRFGs subject to outlined limits; and it requires Pennsylvania to prepare a report no less frequently than every five years that analyzes the revenue and expenses of the account and evaluates the limits on financial guarantees. Additionally, section 86.162b establishes eligibility requirements for recipients of financial guarantees; requires the operator to pay annual premiums to Pennsylvania of 1.5 percent of the total amount of the financial guarantee; requires additional bonds or financial assurance if a postmining pollutional discharge develops; establishes procedures for bond forfeiture from operators who choose to obtain the financial guarantees; and establishes procedures for discontinuing the financial guarantee program.
Subsection (f) imposes several limits on Pennsylvania in issuing financial guarantees. Pennsylvania may not issue financial guarantees exceeding 50 percent of the required bond amount for the permit, and it may not issue guarantees to individual operators in excess of 30 percent of the funds in the account. Pennsylvania also may not issue guarantees to any operators when the total amount of outstanding guarantees exceeds the amount of money in the account divided by the historical rate of bond forfeiture plus a safety margin. The total program limit on financial guarantee amounts aids in assuring solvency of the overall fund. The noted 50 percent limit also enhances solvency by ensuring that operators post traditional performance bonds for 50 percent or more of the reclamation liabilities. These traditional performance bonds will provide a significant economic incentive for compliance with the reclamation plan. The program limits and financial incentives all help Pennsylvania in achieving the objectives of 30 CFR 800.11(e)(1) and (2).
Subsection (g) of this section converts existing financial guarantees previously issued by Pennsylvania into LRFGs. The LRFGs are subject to the operator, permit, and program limits described elsewhere in section 86.162b. The new alternative bonding system will be easier for Pennsylvania to manage by consolidating the previous financial guarantees under the LRFG program. Because Pennsylvania will subject these converted financial guarantees to the limits of subsection (f), the LRFG program will help to assure that the objectives of 30 CFR 800.11(e)(1) and (2) are met, for the same reasons described previously.
Subsection (h) of this section directs Pennsylvania to prepare a report no less frequently than every five years to analyze the revenue and expenses of the LRFG Account and evaluate the limits on financial guarantees. This report is independent of the annual Trust Account report previously discussed. Pennsylvania must submit the report to the Mining and Reclamation Advisory Board (tasked with advising Pennsylvania on all matters of surface mining and reclamation) and make the report available to the public. Subsection (h) requires that, if Pennsylvania changes the financial guarantee limits based on the report, it will publish a notice highlighting those changes in the
Subsections (i) and (j) of this section authorize Pennsylvania to transfer interest and payments from the LRFG Account to the Trust Account, as described at 25 Pa Code 86.17. No new alternative bonding system sites will come into existence because Pennsylvania has transitioned to full-cost bonding. The interest transfer is intended to transition existing alternative bonding system sites to a full funded status for their long-term treatment obligations. Pennsylvania may only use funds in the Trust Account for treating postmining pollutional discharges at alternative bonding system sites. The transfer of funds from one account to another does not affect the overall solvency of Pennsylvania's alternative bonding system. However, a check and balance on these transfers has been included in subsection (j), whereby PADEP must seek input from the Mining and Reclamation Advisory Board prior to any funds transfer into the Trust Account from the LRFG Account. Together these provisions will aid in achieving the objectives of 30 CFR 800.11(e)(1).
Subsection (k) establishes eligibility requirements for those who choose to obtain the financial guarantees. This subsection requires that operators hold valid coal mining leases, satisfy the requirements of subsections 86.37(a)(8) to 86.37(a)(8)(11) and 86.37(a)(8)(16) (relating to correction of previous violations), have a record of making timely payments on previous financial guarantees, and have not failed to maintain proper bonds within the previous three years. Operators obtaining financial guarantees for the first time must demonstrate experience in mining and reclamation by having coal mining licenses for at least five years. Operators must also submit either a surety bond for the remaining portion of the reclamation liability or a letter of acceptance from a surety company. These eligibility requirements reduce the chances of an operator forfeiting a bond by screening out inexperienced operators or operators with uncorrected violation histories. In doing so, this subsection helps assure solvency of the LRFG Account, furthering the objectives of 30 CFR 800.11(e)(1).
Subsection (l) describes the requirements for applications for financial guarantees, which include descriptions of the environmental and safety hazards of the proposed site, the availability of coal reserves at the site, and any prior denials of surety coverage. These requirements will help Pennsylvania select sound investments for financial guarantees and help assure the solvency of the LRFG Account, furthering the objectives of 30 CFR 800.11(e)(1).
Subsection (m) requires operators obtaining a financial guarantee to pay annual premiums to Pennsylvania of 1.5 percent of the total amount of the financial guarantee and imposes related requirements and limitations. This subsection authorizes Pennsylvania to use the annual premiums to fund reclamation activities if bond forfeitures occur or to transfer excess funds to the Trust Account. These provisions help assure the solvency of the LRFG Account, as required by 30 CFR 800.11(e)(1).
Subsection (n) authorizes Pennsylvania to adjust the payment percentage rate to assure the financial stability of the LRFG Account, after soliciting advice from the Mining and Reclamation Advisory Board. The annual premiums will supplement the funds in the Account from the transfer of Pennsylvania's previous financial guarantee program and the annual appropriations from the electricity tax. Together these provisions will aid in achieving the objectives of 30 CFR 800.11(e)(1).
Subsection (o) requires Pennsylvania to reduce or release financial guarantees from the previous CAP before other obligations, followed by financial guarantees from the proposed LRFG program, and finally remaining performance bonds from the operator. By holding onto the remaining performance bonds until after releasing guarantees under the LRFG program, Pennsylvania will maintain the substantial economic incentive for the operator to fulfill its reclamation obligations as required in 30 CFR 800.11(e)(2).
Subsection (p) requires that when a postmining pollutional discharge develops, the operator must provide Pennsylvania with a separate bond or financial assurance to cover long-term treatment costs. The requirement for separate bond mechanisms for long-term treatment of pollutional discharges is no less effective than the Federal regulations at 30 CFR 800.40(c)(3), which stipulate that no bond can be fully released until the operator meets all reclamation requirements. By helping to ensure coverage of all reclamation liability, including the often late-arising liability associated with discovery of pollutional discharges, it is also no less stringent than section 509(a) of SMCRA, 30 U.S.C. 1259(a), which requires a bond “sufficient to assure the completion of the reclamation plan if the work had to be performed by the regulatory authority . . . .”
Subsections (q) through (s) establish the procedures for bond forfeiture under the LRFG program. In such cases, Pennsylvania will declare forfeiture of the financial guarantee and the operator's other performance bonds and use the money to complete reclamation of the site. The forfeiture declaration will not discharge the operator's obligation to meet other requirements under the Pennsylvania regulatory program. These procedures are identical to the Federal regulation at 30 CFR 800.50 and are therefore as effective as those regulations.
Subsection (t) provides that Pennsylvania may suspend issuance of financial guarantees when the number of participating permits declared forfeit equals the number of participating permits multiplied by the historical forfeiture rate, plus a margin of safety. This subsection also provides that Pennsylvania may resume the financial guarantee program after evaluating and approving adequate funding levels with advice from the Mining and Reclamation Advisory Board. Subsection (u) provides that Pennsylvania will discontinue issuance of financial guarantees if 25 percent or more of the outstanding bond obligations for LRFGs are declared forfeit under section 86.181. Subsection (v) provides that Pennsylvania will not approve additional financial guarantees after the program is discontinued and that outstanding financial guarantees will remain in effect until released. We have determined that subsections (t), (u), and (v) have no direct Federal counterpart, but because they operate as additional mechanisms to promote solvency of the LRFG Account, we deem them no less effective than the Federal regulations at 30 CFR 800.11(e). The ability to suspend or discontinue issuance of financial guarantees to protect the solvency of the fund is consistent with the Federal regulations at 30 CFR 800.11(e)(1).
Section 86.162b includes numerous provisions implementing the LRFG Account and ensuring orderly program administration. Subsections (a) through (v) detail these additions and, as described in this
Pennsylvania revised this section to add a provision that if an operator fails to pay annual premiums for LRFGs as
Pennsylvania revised this section to remove a reference to sum-certain financial guarantees under the predecessor program and replace it with a reference to LRFGs as implemented by section 86.162b. This replacement allows Pennsylvania to deposit fees collected for the LRFGs into the Trust Account. In conjunction with section 86.162b, the changes in section 86.187 referencing the LFRG allow the transfer of fees from the CAP. This section also changes a citation to PASMCRA to reflect the addition of 52 P.S. 1396.19b and changes `monies' to `moneys.'
Pennsylvania, through Act 95, revised section 4 of PASMCRA by adding a sentence at the end of subsection 4(a)(2)(C) directing PADEP to encourage and promote the use of various bioenergy crops, including switchgrass, camelina, and canola for the revegetation of surface mining sites and providing that Pennsylvania will consider such sites to have a postmining land use of cropland.
Pennsylvania revised PASMCRA by adding section 4.14, which directs PADEP to make available sum-certain financial guarantees to cover Stage III reclamation liability for remining sites revegetated with bioenergy crops, to the extent that funds are available for the financial guarantees. Pennsylvania describes the implementation of the financial guarantees in additional statutory changes and in new chapters of the Pennsylvania Code.
Pennsylvania added this section to chapter 86 of its administrative code, providing for the issuance of financial guarantees in the form of bioenergy crop bonding. Section 86.162c would provide operators at remining sites with an incentive to plant bioenergy crops, consistent with section 4.14 of PASMCRA. Pennsylvania releases bonds in three stages. Stage 1 release occurs after the site has been regraded to the approximate original contour and drainage control installation has occurred. Stage 2 release occurs after successful revegetation of the permit area. Stage 3 release occurs after final completion of the reclamation plan and a minimum of five years following Stage 2 bond release. The proposed bioenergy crop bond would release the operator's Stage 3 bonds and replace them with a financial guarantee.
Paragraph (a) describes the eligibility requirements for the bond. Operators may apply for the bioenergy crop bonding at remining sites after Stage 2 bond release and after demonstrating successful growth of bioenergy crops including switchgrass, camelina, and canola. Operators may not apply for bioenergy crop bonding if water treatment liability has been triggered under Pennsylvania's regulations on remining areas with pollutional discharges.
Paragraph (b) describes the application requirements for the bond. Applications must include verification that the permitted area has achieved Stage 2 bond release, demonstration that the operator is growing bioenergy crops at an acceptable yield, demonstration that temporary structures have been reclaimed, that there are no postmining pollutional discharges or that all liabilities for discharges are covered with a full-cost bond, and a statement that the operator intends to apply for release of bioenergy crop bonding in a timely manner.
Paragraphs (c) through (f) establish the procedures for approving bioenergy crop bonding. Only after approval may Pennsylvania release the operator's existing Stage 3 bond. Bioenergy crop bonding cannot exceed five years and will expire within 120 days of the expiration of the liability period. If final bond release does not occur until after expiration of bioenergy crop bonding, replacement bioenergy crop bonding is required.
Subsection 86.162c implements the statutory provisions in section 4.14 of PASMCR, which establishes bioenergy crop bonding as a financial incentive to encourage the growth of bioenergy crops at remining sites. To provide a
We conclude the minimum five-year liability period for bioenergy crop bonding is no less effective than 30 CFR 816.116(c)(2), which requires that sites which receive at least 26 inches of annual average precipitation have liability periods of five years, except in the case of remining sites, where the period of liability is two years. Further, subsection 816.116(b)(5) of the Federal regulations requires vegetation at remining sites to match or exceed the previous extent of ground cover and be adequate to control erosion. The density of vegetation in a cropland safely meets these standards. For these reasons, we are approving section 86.162c.
There were numerous non-substantive changes as to which OSMRE makes no findings. These changes may be found in PADEP's July 26, 2017, letter (Administrative Record No. PA 900.00) (pp. 3 to 29).
We asked for public comments on the amendment and did not receive any during the comment period.
On August 7, 2017, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Pennsylvania program (Administrative Record No. PA 900.01). We did not receive any comments.
Under 30 CFR 732.17(h)(11)(ii), we are required to obtain a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On August 7, 2017, we requested comments on the Pennsylvania amendment (Administrative Record No. 900.01). Neither the SHPO nor ACHP responded with any comments.
Based on the above findings, we are approving the Pennsylvania amendment sent to us on July 26, 2017 (Administrative Record No. PA 900.00). To implement this decision, we are amending the Federal regulations at 30 CFR part 938 that codify decisions concerning the Pennsylvania program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication.
This rule would not effect a taking of private property or otherwise have taking implications that would result in public property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.
Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), the approval of State program amendments is exempted from OMB review under Executive Order 12866, as amended by Executive Order 14094. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.
The Department of the Interior has reviewed this rule as required by section 3 of Executive Order 12988. The Department determined that this
This rule has potential Federalism implications as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. Pennsylvania, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the State level. This rule approves an amendment to the Pennsylvania State program submitted and drafted by the State, and
The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Tribes or on the distribution of power and responsibilities between the Federal government and Tribes. The basis for this determination is that our decision on the Pennsylvania program does not include Indian lands, as defined by SMCRA, or regulation of activities on Indian lands. Indian lands are regulated independently under the applicable Federal program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.
Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.
Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C).
This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.
This rule does not impose an unfunded mandate on State, local, or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 938 is amended as set forth below:
30 U.S.C. 1201
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving a request from Pennsylvania for the removal of a required amendment to the Pennsylvania regulatory program (hereinafter, the Pennsylvania program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The required amendment directed Pennsylvania to submit regulations requiring that siltation structures (
The effective date is September 9, 2024.
Ben Owens, Acting Field Office Director, Pittsburgh Field Office, Office of Surface Mining Reclamation and Enforcement, Telephone: (412) 937-2827. Email:
Subject to OSMRE oversight, Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations.
By letter dated August 9, 2018 (Administrative Record No. PA 903.00), Pennsylvania requested removal of a required amendment from its program. This amendment, 30 CFR 938.16(rrr), requires Pennsylvania to amend three subsections in title 25 of the Pennsylvania Code (Pa. Code), specifically subsections 87.108(c),
We gave notice of receipt of Pennsylvania's August 9, 2018, request in the May 1, 2019,
We are approving Pennsylvania's request to eliminate the required amendment as described below and approving language we previously rejected as being less effective than the Federal regulations. The following are findings we made concerning Pennsylvania's request under SMCRA at 30 U.S.C. 1253,
With this request, Pennsylvania presents a number of reasons why the required amendment should be removed and why previously submitted language revising 25 Pa. Code 87.108(c)—Sedimentation Ponds: Surface Coal Mines; 89.24(c)—Sedimentation Ponds: Underground Mines and Coal Preparation Facilities; and 90.108(c)—Sedimentation Ponds: Coal Refuse Disposal should be approved. The previously submitted revised language required that sedimentation ponds be maintained until the disturbed area has been stabilized and revegetated and removal is approved by the Department, and that the ponds may not be removed sooner than 2 years after the last augmented seeding unless the Department finds that the disturbed area has been sufficiently revegetated and stabilized.
In support of removing the required amendment and accepting the revised language, Pennsylvania identifies the 1985 court decision in
Pennsylvania's submission also references Montana and Ohio as successfully amending their programs and receiving OSMRE approval to allow removal of sedimentation ponds sooner than two years after last augmented seeding if replaced by BTCA.
In support of removing the required amendment and accepting the revised language, Pennsylvania also indicates that 25 Pa. Code 87.108(c), 89.24(c), and
In further support of removing the required amendment and accepting the revised language, Pennsylvania recounts its experience with revegetation and notes that revegetation is often established in less than two years. Pennsylvania adds that because siltation structures pose reclamation liability and, in some cases, a potential public safety hazard, they should be removed as soon as they are no longer necessary, which is often less than two years.
Finally, in support of removing the required amendment and accepting the revised language, Pennsylvania states that there is no statutory prohibition to Pennsylvania's approach.
In conclusion, Pennsylvania asserts that its program's approach, with the revised language and without the required amendment, is no less effective than the Federal program for the reasons mentioned above. Therefore, Pennsylvania is requesting that the required program amendment at 30 CFR 938.16(rrr) be removed and proposed revisions to 25 Pa. Code sections 87.108(c), 89.24(c), and 90.108(c) be approved.
The Federal regulations at 30 CFR parts 816 and 817 (Permanent program performance standards for surface mining and underground mining, respectively) require operators to minimize disturbance of the hydrologic balance within the permit and adjacent areas and to prevent material damage to the hydrologic balance outside the permit area during mining and reclamation activities. 30 CFR 816.41(a) and 817.41(a). The standards address groundwater and surface water protections and include a requirement that additional contributions to streamflow of suspended solids or runoff outside the permit area be prevented to the extent possible using the BTCA. 30 CFR 816.45(a)(1) and 817.45(a).
To assist in achieving these objectives, operators often construct siltation structures for sediment control of surface drainage. The Federal regulations define a siltation structure as “a sedimentation pond, a series of sedimentation ponds, or other treatment facility.” 30 CFR 701.5. Siltation structures were originally considered by OSMRE to be the BTCA. They are designed, constructed, and maintained to provide adequate sediment storage volume and adequate detention time to allow the effluent from the ponds to meet State and Federal effluent limitations. As discussed below, the Federal regulation at 30 CFR 816.46(b)(5) specifically prohibits removal of siltation structures sooner than two years after the last augmented seeding.
Challengers of a 1983 Federal rule that, in part, expanded the definition of “siltation structure” to include “other treatment facilities” (51 FR 41952) asserted in litigation that, in certain circumstances, siltation structures of any type can cause adverse effects on the hydrologic balance. The court concluded that the preamble to the final rule failed to provide sufficient rationale for requiring siltation structures in every instance.
Since the suspension in 1986, OSMRE has approved revisions to two State programs (Montana and Ohio) to allow the removal of siltation structures sooner than two years after last augmented seeding if replaced by BTCA. In 1990, OSMRE approved a revision to Montana's program and the two-year retention requirement for sedimentation ponds and siltation structures.
The required amendment Pennsylvania seeks to remove here was imposed by OSMRE in response to a 1996 proposed amendment by PADEP. The proposed amendment covered a number of provisions and a range of topics including revisions to 25 Pa. Code sections 87.108(c), 89.24(c), and 90.108(c), which would have allowed reclamation of sedimentation ponds in less than two years.
Unlike the Montana and Ohio revisions, referenced above, Pennsylvania's 1996 submission made no reference to any requirement that removal of siltation structures sooner than two years after the last augmented seeding would be approved upon a demonstration that revegetation is the BTCA for sediment control.
Because Pennsylvania's proposal presumptively precluded the use of any “other treatment facilities” and required the use of sedimentation ponds rather than any other treatment method, OSMRE did not approve an exception to the temporal requirement related to siltation structure removal. Therefore, OSMRE did not approve revisions to 25 Pa. Code sections 87.108(c), 89.24(c),
In its request to remove required amendment 30 CFR 938.16(rrr), Pennsylvania presents a more robust justification for why the required amendment should be removed and why Pennsylvania's approach, including the revisions to 25 Pa. Code sections 87.108(c), 89.24(c), and 90.108(c), should be approved.
The Federal regulation at 30 CFR 816.46(b)(5) requires that siltation structures not be removed sooner than two years after the last augmented seeding. However, the Federal regulations at 30 CFR 816.46(b)(2) and 817.46(b)(2), which mandated use of siltation structures, were suspended on November 29, 1986 (51 FR 41952) because the preamble failed to provide a sufficient rationale for requiring siltation structures in every instance. Explaining the effect of the suspensions, OSMRE stated that the “regulatory authority must determine on a case-by-case basis what constitutes the `best technology currently available' as required by the Act and 30 CFR 701.5 which defines BTCA.” 51 FR 41957.
The effect of this suspension is to require that sediment control of surface drainage be governed by BTCA rather than requiring such drainage to be passed specifically through siltation structures for two years. In the 1986 rulemaking, OSMRE announced, in light of the change, that when measures other than siltation structures (which would include vegetation) are determined to be BTCA, the performance standards of 30 CFR 816.45 will control. 51 FR 41957. OSMRE then explained that where siltation structures are determined to be BTCA, the performance standards in 30 CFR 816.46(b)-(d) will control. 51 FR 41957-41958.
Under Pennsylvania's current program, if PADEP determines that a disturbed area featuring a siltation structure has been sufficiently revegetated and stabilized, it may conclude that vegetation has become BTCA, regardless of whether the siltation structure has been in place for two years from the last augmented seeding. This conclusion is consistent with the 1986 rulemaking, in which we indicated that “the regulatory authority must determine on a case-by-case basis what constitutes the `best technology currently available.' ” 51 FR 41957. It is also consistent with our determinations in the Montana and Ohio rulemakings where we approved rules that allowed removal of siltation structures in less than two years if replaced by measures determined to be BTCA. BTCA is defined in the Federal regulations at 30 CFR 701.5 as:
The Federal regulations require the approval of the regulatory authority before siltation structures can be removed. As noted, Pennsylvania's submission points out that siltation structures must be maintained until the regulatory authority finds the disturbed area has been stabilized and revegetated.
Pennsylvania asserts that there are no Federal statutory prohibitions that preclude approval of its request to allow removal of siltation structures sooner than two years following last augmented seeding. We recognize that the SMCRA provisions at 30 U.S.C. 1265(b)(10)(B)(i) and 1266(b)(9)(B) do not prescribe the type of BTCA to be used to control sediment. As discussed in the November 20, 1986,
For the reasons explained above, we find that removal of the required amendment at 30 CFR 938.16(rrr) and approval of the revised language to 25 Pa. Code sections 87.108(c), 89.24(c), and 90.108(c), would result in a program that is no less effective than the Federal regulations at 30 CFR 816.46(b)(1) and 816.46(b)(5) and that is consistent with SMCRA, and we are thus approving the request to remove the required amendment and approving the proposed revisions to 25 Pa. Code sections 87.108(c), 89.24(c), and 90.108(c).
In the May 1, 2019,
On August 27, 2018, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Pennsylvania program (Administrative Record No. PA 903.01). We did not receive any comments.
Under 30 CFR 732.17(h)(11)(ii), we are required to obtain written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Based on the above findings, we are approving the request from Pennsylvania sent to us on August 6, 2018 (Administrative Record No. PA 903.00). To implement this decision, we are amending the Federal regulations at 30 CFR 938.16 that codify decisions concerning the Pennsylvania program by removing subsection 938.16(rrr). We are also approving the proposed revisions to 25 Pa. Code sections 87.108(c), 89.24(c), and 90.108(c). In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. SMCRA requires consistency of State and Federal standards, and we have determined that Pennsylvania's program, without the required amendment, achieves this.
This rule would not effect a taking of private property or otherwise have taking implications that would result in private property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.
Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), the approval of State program and/or plan amendments is exempted from OMB review under Executive Order 12866, as amended by Executive Order 14094. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.
The Department of the Interior has reviewed this rule as required by Section 3 of Executive Order 12988. The Department determined that this
This rule has no potential Federalism implications as defined under Section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. Pennsylvania, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the State level. This rule only corrects the CFR to reflect our prior approvals of the Pennsylvania program submitted and drafted by the State and, thus, has no effect on the maximum administrative discretion we are directed to give to States.
The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal Government and Tribes. The basis for this determination is that our decision on the Pennsylvania program does not include Indian lands as defined by SMCRA or other Tribal lands and it does not affect the regulation of activities on Indian lands or other Tribal lands. Indian lands under SMCRA are regulated independently under the applicable Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with minable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.
Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not a significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.
Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively, and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C).
This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.
This rule does not impose an unfunded mandate on State, local, or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 938 is amended as set forth below:
30 U.S.C. 1201
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the West Virginia regulatory program (the West Virginia program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). This amendment revises West Virginia's regulatory program provisions related to entities authorized to issue surety bonds and the repair and compensation of damage resulting from subsidence.
Effective September 9, 2024.
Mr. Michael Castle, Acting Director, Charleston Field Office Telephone: (304) 347-7158.
Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its approved State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations.
By letter dated May 5, 2020 (Administrative Record No. 1640), West Virginia sent us an amendment to its program under SMCRA (30 U.S.C. 1201
We announced receipt of the proposed amendment in the December 16, 2020,
The following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below. The full text of the program amendment is available for review at
West Virginia seeks to revise CSR 38-2-11.3.a.3, which requires any company that executes surety bonds in the State to either: (i) be included on the United States Department of the Treasury's (Treasury Department) listing of approved sureties; or (ii) to submit proof to the West Virginia Department of Environmental Protection (WVDEP) that it holds a valid license issued by the West Virginia Insurance Commissioner and meets certain reporting obligations. The existing provision further requires any company not included on the Treasury Department's listing of approved sureties to diligently pursue application for such listing, submit proof of its efforts, and become listed within 4 years. The revision would specify that only those companies electing to qualify under the first part must diligently pursue application for listing with the Treasury Department if they do not currently possess that certification. In other words, companies that elect to submit proof of a valid license from the West Virginia Insurance Commissioner and meet certain reporting obligations would no longer be required to diligently pursue application for listing or be listed with the Treasury Department.
Since 2005, WVDEP has learned that under W.Va. Code sec. 33-4-14, corporate sureties must annually submit to the West Virginia Insurance Commissioner a true quarterly statement of their financial condition, transactions, and affairs as of March 31, June 30, and September 30 in order to do business in West Virginia. As a consequence of the current amendment, WVDEP will be relying on the expertise and review of the West Virginia Insurance Commission, because it is responsible for the licensing, financial monitoring, and financial examination of the companies admitted to do business in West Virginia. As amended, we find the revision to be no less effective than the Federal regulation at 30 CFR 800.20(a), which states that a surety bond shall be executed by the operator and a corporate surety licensed to do business in the State where the operation is located, and no less stringent than section 509(b) of SMCRA. Therefore, we approve this amendment.
West Virginia seeks to revise CSR 38-2-16.2.c.2 relating to the correction of material damage to any structures or facilities resulting from subsidence. The existing regulation requires operators to either repair the damage or compensate the owner for the full amount of diminution in value resulting from the subsidence. West Virginia proposes to revise this provision to state explicitly that the choice of remedy is the owners' and to replace the option of repair with an option to be compensated in the amount of the repair, subject to the limitation that the compensation not exceed one hundred and twenty percent (120%) of the pre-mining value of the structure or facility. The proposal also inserts new language clarifying that this section neither creates additional property rights nor can it be construed as vesting in WVDEP's secretary the jurisdiction to adjudicate property rights disputes.
OSMRE revised its subsidence control regulations in 1995 to implement the Energy Policy Act of 1992 (the Energy Policy Act), enacted on October 24, 1992, which amended SMCRA by adding section 720. 60 FR 16722 (Mar. 31, 1995). Section 720(a) of SMCRA itself specifically focuses on the operators' obligations, providing, in relevant part: “Underground coal mining operations . . . shall comply with each of the following requirements: (1) Promptly repair, or compensate for, material damage resulting from subsidence. . . .” 30 U.S.C. 1309a(a). The final regulation did likewise, providing in relevant part: “The permittee must promptly repair, or compensate the owner for, material damage resulting from subsidence. . . .” 30 CFR 817.121(c)(2). These provisions only reference the owners of materially damaged structures with respect to how they must be compensated should compensation occur in lieu of repair. While the preamble to our 1995 final rule did not explicitly state that the option to repair or replace is the operator's, that interpretation is evident in our discussion of 30 CFR 817.121(c)(5) (Adjustment of bond amount for subsidence damage), in which we state: “Further, the final rule provides that if the permittee intends to repair the damage, the required additional bond would amount to the estimated cost of the repairs. If the permittee intends to compensate the owner, the additional bond would amount to the diminution in value of the protected land or structures.” 60 FR at 16741. This reading is also consistent with the preamble to our initial program regulations, written before the Energy Policy Act was enacted, which indicated the operator had the choice between repair and compensation.
OSMRE has approved alternatives to the options provided under SMCRA, including Pennsylvania's omission of compensation for the decrease in value of the structure in favor of compensation for the reasonable cost of repair or reasonable cost of replacement.
In West Virginia, if the cost of repair or replacement exceeds 120% of the pre-mining value of the structure, the operator retains the alternative option to compensate the owner for the loss in value rather than pursue repair or replacement. By allowing the landowner to choose the greater compensation that would otherwise be available under section 720(a)(1) of SMCRA, though not without limit, West Virginia's proposed amendment is not less stringent than SMCRA nor less effective than 30 CFR 817.121, and, therefore, we are approving it. We are also approving the revision clarifying that CSR 38-2-16.2.c.2 does not create additional property rights or vest in the WVDEP Secretary the jurisdiction to adjudicate property rights. Nothing in SMCRA creates property rights or vests in, or requires, any State regulatory authority to adjudicate property rights, which are typically adjudicated in State court.
On December 16, 2020, we published a
A. WVCA stated in its letter that the plain language of the Federal regulations make clear that the operator decides whether to repair a structure or facility or pay compensation in the amount of the diminution in value. WVCA traced much of the regulatory history of our regulation at 30 CFR 817.121 from 1979 to present in support of its assertion. WVCA asserts that the current amendment, which gives the surface landowner the power to choose the remedy, makes CSR 38-2-16.2.c.2 more stringent than the Federal requirement and strikes a fair and equitable balance between common law property rights and the duty to protect surface owners from the potentially adverse impacts of coal extraction.
B. WVCA stated that the revision to CSR 38-2-11.3.a.3 makes this regulation functionally identical to the corresponding provision of the Federal regulations and supports its approval.
C. A commenter stated that the rights of the surface and mineral owners and other persons with legal interest in the land should be adequately protected. The commenter noted that CSR 38-2-16.2.c.2 is similar, if not verbatim, to the correlating Federal regulation and asserted that under these provisions, if a monetary settlement cannot be reached, the surface owner can require the coal operator to repair the structures or facilities without a stated restriction as to cost. The commenter argued that eliminating the operator's obligation to repair the structure or facility and placing a limit on the amount of compensation for repair is inequitable due to the variability and difficulty of appraising the value of certain structures and facilities, including homes on different acreages, barns, utility buildings, and bridges that allow access to the property. The commenter stated that this has led to scenarios where the cost of repair greatly exceeded 120% of the pre-mining value of the structure or facility.
On May 5, 2020 (Administrative Record No. WV-1646), under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the West Virginia program. We did not receive any comments.
Under 30 CFR 732.17(h)(11)(ii), we are required to obtain written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On May 5, 2020, we requested comments on West Virginia's amendment (Administrative Record No. 1646). We did not receive comments from the SHPO or ACHP.
Based on the above findings, we are approving the West Virginia amendment that was submitted on May 5, 2020 (Administrative Record No. 1640). To implement this decision, we are amending the Federal regulations at 30 CFR part 948 that codify decisions concerning the West Virginia program. In accordance with the Administrative Procedure Act (5 U.S.C. 533), this rule will take effect 30 days after the date of publication.
This rule would not effect a taking of private property or otherwise have taking implications that would result in public property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.
Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), the approval of State program amendments is exempted from OMB review under Executive Order 12866, as amended by Executive Order 14094. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.
The Department of the Interior has reviewed this rule as required by section 3 of Executive Order 12988. The Department determined that this
This rule has potential Federalism implications as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. West Virginia, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the State level. This rule approves an amendment to the West Virginia program submitted and drafted by the State, and thus is consistent with the direction to provide maximum administrative discretion to States.
The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal government and Tribes. The basis for this determination is that our decision on the West Virginia program does not include Indian lands as defined by SMCRA or other Tribal lands and it does not affect the regulation of activities on Indian lands or other Tribal lands. Indian lands under SMCRA are regulated independently under the applicable approved Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.
Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is
Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C).
This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.
This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 948 is amended as set forth below:
30 U.S.C. 1201
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the waters of the Upper Mississippi River from mile marker 497.6 to 497.2. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the Great River Tug Fest and Firework display. Entry of vessels or persons into the zone is prohibited unless specifically authorized by the Captain of the Port, Sector Upper Mississippi River, or a designated representative.
This rule is effective from 8:30 p.m. August 9, 2024 through 11 p.m. August 10, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Commander Lars Okmark, Sector Upper Mississippi River Waterways Management Division, U.S. Coast Guard; telephone 314-269-2560, email
The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule, as doing so would be impracticable. This is because we must establish this safety zone by August 9, 2024 to protect the personnel, vessels, and the marine environment from the potential dangers associated with fireworks and the festival events including a tug of war across the river. We therefore lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.
Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Upper Mississippi River (COTP) has determined a safety zone is necessary to protect personnel, vessels, and the marine environment in the navigable waters from potential hazards created by the Great River Tug Fest and Firework display.
This rule establishes a temporary safety zone on the waters of the Upper Mississippi River from mile markers 497.6 to 497.2 in LeClaire, IA and Port Byron, IL, from 8:30 p.m. August 9, 2024 to 11 p.m. on August 10, 2024. The safety zone is subject to enforcement during the following times: 8:30 p.m. to 11 p.m. on August 9, 2024; 10:30 a.m. to 4 p.m. on August 10, 2024; and 8:30 p.m. to 11 p.m. on August 10, 2024. Fireworks are scheduled for the evening of August 9, 2024, with a rain date scheduled for the evening of August 10, 2024. Other Tug Fest activities requiring a safety zone are occurring late morning through late afternoon of August 10, 2024. The duration of this safety zone is intended to protect personnel, vessels, and the marine environment from potential hazards created by the Great River Tug Fest and Firework display. This rule resulted from concerns about the high number of recreational vessels attending the festival and fireworks display that will create unsafe conditions when combined with passing barge traffic on the Upper Mississippi River from MM 497.6 to 497.2. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. As used in this section, a designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Upper Mississippi River or a Federal, State, or local officer designated by or assisting the COTP. The COTP or a designated representative will inform the public of the enforcement date and times for these safety zones, as well as any emergent safety concerns that may delay the enforcement of the zone.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on size, location, and duration of the temporary safety zone. This action involves a safety zone to protect personnel, vessels, and the marine environment from potential hazards created by the Great River Tug Fest and Firework display. This rule resulted from concerns about a high number of recreational vessels attending the fest and firework display that will create unsafe conditions when combined with passing barge traffic on the Upper Mississippi River from MM 497.6 to 497.2. In addition, the rule will only close the river for short periods of time for two days. Moreover, the Coast Guard will publish a Local Notice to Mariners and mariners may seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone on the Upper Mississippi River from MM 497.6 to 497.2 for short periods of time over two days. It is categorically excluded from further review under paragraph L60(a) of appendix A, table 1 of DHS Instruction Manual 023-01-001-01, Rev. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or a designated representative via VHF-FM channel 16, or through USCG Sector Upper Mississippi River at 314-269-2332. Persons and vessels permitted to enter the safety zone must comply with all lawful orders or directions issued by the COTP or designated representative.
(d)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of
This regulation is effective August 8, 2024. Objections and requests for hearings must be received on or before October 7, 2024, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2022-0939, is
Madison Le, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1400; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0939 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 7, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0939, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . . ” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other factors, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”
EPA evaluated the available toxicity and exposure data on IPD079Ea protein and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. A summary of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Product Characterization Review and Human Health Risk Assessment of the Insecticidal Plant-Incorporated Protectant Active Ingredient
The IPD079Ea protein, encoded by the
Residential and non-occupational exposures are expected to be minimal given that the IPD079Ea protein is a plant-incorporated protectant in corn. The only possible route of non-occupational exposure other than dietary is via handling of the plants and plant products. Exposures via the skin or inhalation are expected to be minimal given that the IPD079Ea protein is embedded in the matrix of the plant, which essentially eliminates or reduces dermal and inhalation routes of exposure to negligible levels. Furthermore, IPD079Ea protein expression in leaf tissue, forage, and pollen is very low. Together, there are no risks associated with these exposure routes because IPD079Ea protein is present in the plant at low levels and is not toxic or allergenic. These findings are discussed in more detail in the Human Health Risk Assessment.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found the IPD079Ea protein to share a common mechanism of toxicity with any other substances, and the IPD079Ea protein does not appear to produce a toxic metabolite produced by other substances. Therefore, EPA has assumed that IPD079Ea protein does not have a common mechanism of toxicity with other substances.
Although FFDCA section 408(b)(2)(C) provides for an additional tenfold margin of safety for infants and children in the case of threshold effects, EPA has determined that there are no such effects due to the lack of toxicity and allergenicity of the IPD079Ea protein. As a result, an additional margin of safety for the protection of infants and children is unnecessary.
Based upon its evaluation described above and in the Human Health Risk Assessment, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the IPD079Ea protein. Therefore, an exemption from the requirement of a tolerance is established for residues of the IPD079Ea protein in or on the food and feed commodities of corn: corn, field; corn, sweet; and corn, pop when used as a plant-incorporated protectant in corn.
EPA has determined that an analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. Nonetheless, a protocol for a lateral flow test kit was submitted for detection of IPD079Ea protein. The submitted protocol adequately describes the methodology.
This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:
7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.
Residues of
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of indoxacarb in or on multiple crops listed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective August 8, 2024. Objections and requests for hearings must be received on or before October 7, 2024, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0079, is available at
Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e-CFR site at:
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2023-0079 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 7, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0079, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, are available at
In the
The petition also proposed to remove established tolerances for residues of indoxacarb in or on the following: Bean, dry seed; Bean, succulent; Corn, field, grain; Corn, pop, grain; Corn, sweet, kernel plus cob with husk removed; Cotton, undelinted seed; Fruit, pome, except pear, group 11; Fruit, stone, group 12; Okra; Pea, southern, seed; Pear, oriental; Turnip, greens; Vegetable,
That document referenced a summary of the petition, which is available in the docket,
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for indoxacarb including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indoxacarb follows.
In an effort to streamline its publications in the
EPA has previously published several tolerance rulemakings for indoxacarb, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to indoxacarb and established tolerances for residues of that chemical. EPA is incorporating previously published sections of those rulemakings that remain unchanged, as described further in this rulemaking. Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by indoxacarb, can be found in the document titled “Indoxacarb. Human Health Risk Assessment for Section 3 Registration in/on Coffee, Strawberry, and Sunflower Crop Subgroup 20B; and Crop Group Conversions and Expansions” which is available in the docket for this action at
Acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). Partially refined acute probabilistic and chronic dietary analyses were conducted using percent crop treated data. For food commodities, residue distribution files were constructed from field trial residues for the probabilistic acute dietary assessment as appropriate, and average residues were computed for blended commodities and for the chronic dietary assessment.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
•
•
•
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
For the acute dietary risk assessment, the following maximum PCT estimates were used: apples (15%); apricots (15%); broccoli (40%), cabbage (35%); cauliflower (50%); celery (10%); cherries (2.5%); corn (2.5%); cotton (2.5%); cucumbers (10%); lettuce (15%); nectarines (40%); peaches (15%); peanuts (5%); peppers (20%); plums/prunes (15%); potatoes (2.5%); pumpkins (2.5%); soybeans (2.5%); spinach (2.5%); squash (10%); sweet corn (5%); tomatoes (15%); and watermelons (2.5%).
For the chronic dietary assessment, the following average PCT estimates were used: apples (10%); apricots (2.5%); broccoli (30%), cabbage (20%); cauliflower (25%); celery (5%); cherries (1%); corn (1%); cotton (1%); cucumbers (2.5%); lettuce (5%); nectarines (30%); peaches (10%); peanuts (1%); peppers (10%); plums (5%); potatoes (1%); prunes (1%); pumpkins (1%); soybeans (1%); spinach (1%); squash (2.5%); sweet corn (1%); tomatoes (10%); and watermelons (1%).
For all other crop commodities with indoxacarb uses and for the proposed new uses of indoxacarb, the assessment assumed that 100% of the crop was treated.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5% as the average PCT value, respectively. In those cases, the Agency would use 1% or 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses 2.5% as the maximum PCT.
The Agency believes that Conditions a, b, and c discussed above have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which indoxacarb may be applied in a particular area.
There are no residential/non-occupational uses of indoxacarb proposed for the current action, however, there are currently registered uses of indoxacarb that may result in residential handler and post-application exposures. The residential exposure scenarios used in the aggregate exposure assessment are as follows: the short-term residential exposure for use in the child (1 to less than 2 years old) aggregate assessment is incidental oral (hand to mouth) exposures from post-application exposure resulting from spot (course/pin stream) applications to hard/carpeted surfaces and the intermediate-/long-term residential exposure for use in the child (1 to less than 2 years old) aggregate assessment is incidental oral (hand to mouth) exposures from post-application exposure to treated pets (dogs).
Acute dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the aPAD;
The short- and intermediate-term aggregate risks combine chronic dietary (food and drinking water) and short- and intermediate-term residential exposures. For the short-term aggregate risk for children 1 to less than 2 years old, the aggregate MOE is 120. For the intermediate/long-term aggregate risk for children 1 to less than 2 years old, the aggregate MOE is 250. MOEs below 100 are of concern; these MOEs are above 100 and therefore are not of concern.
Because indoxacarb is classified as “not likely to be carcinogenic to humans”, EPA has concluded that aggregate exposure to indoxacarb is not likely to pose a cancer risk.
Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to indoxacarb residues.
For a discussion of the available analytical enforcement method, see Unit IV.A. of the November 16, 2020, rulemaking.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).
The U.S. and Codex are harmonized with respect to the residue definition for the commodities included in this petition. There are no Codex MRLs for sunflower, coffee, and strawberry. The U.S. tolerance for residues of indoxacarb in or on stone fruit group 12-12 is harmonized with the Codex MRL for stone fruits at 1 ppm, and the U.S. tolerance for residues of indoxacarb in or on Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E is harmonized with the Codex MRL for mung bean (dry) at 0.2 ppm. The U.S. tolerance levels are not harmonized with Codex commodity MRLs for the following groups/subgroups: Cottonseed subgroup 20C; Fruit, pome, group 11-10, except pear; Leafy greens subgroup 4-16A; Vegetable,
Therefore, tolerances are established for residues of indoxacarb in or on
Additionally, the established tolerances on Bean, dry seed; Bean, succulent; Corn, field, grain; Corn, pop, grain; Corn, sweet, kernel plus cob with husk removed; Cotton, undelinted seed; Fruit, pome, except pear, group 11; Fruit, stone, group 12; Okra; Pea, southern, seed; Pear, oriental; Turnip, greens; Vegetable,
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter 1 as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
(1) * * *
Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services.
Final rule.
The Department of Health and Human Services (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its statutes and regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Katrina Brisbon, Deputy Assistant Secretary, Office of Acquisitions, Office of the Assistant Secretary for Financial Resources, Room 536-H, Hubert Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201; (202) 260-6677.
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74) (the “2015 Act”) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890 (1990)), which is intended to improve the effectiveness of CMPs and to maintain the deterrent effect of such penalties, requires agencies to adjust the CMPs for inflation annually.
HHS lists the CMP authorities and the amounts administered by all of its agencies in tabular form in 45 CFR 102.3, which was issued in an interim final rule published in the September 6, 2016, issue of the
The annual inflation adjustment for each applicable CMP is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each CMP was most recently established or modified. In the December 19, 2023, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-24-07, “Implementation of Penalty Inflation Adjustments for 2024, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2024, based on the CPI-U for the month of October 2023, not seasonally adjusted, is 1.03241. The multiplier is applied to each applicable penalty amount that was updated and published for fiscal year (FY) 2023 and is rounded to the nearest dollar.
In addition to the inflation adjustments for 2023, this final rule makes a few non-substantive changes to punctuation in the table in 45 CFR 102.3.
The 2015 Act requires Federal agencies to publish annual penalty inflation adjustments notwithstanding section 553 of the Administrative Procedure Act (APA). Section 4(a) of the 2015 Act directs Federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the
Consistent with the language of the 2015 Act and OMB's implementation guidance, the inflation adjustments set out in this rule are not subject to notice and an opportunity for public comment and will be effective immediately upon publication.
Pursuant to OMB Memorandum M-24-07, HHS has determined that the annual inflation adjustment to the civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures.
This rule is effective on the date specified in the
Administrative practice and procedure, Penalties.
For reasons discussed in the preamble, the Department of Health and Human Services amends subtitle A, title 45 of the Code of Federal Regulations as follows:
Pub. L. 101-410, Sec. 701 of Pub. L. 114-74, 31 U.S.C. 3801-3812.
Federal Maritime Commission.
Notification of availability.
The Federal Maritime Commission (Commission) is issuing this document to advise the public of the availability of a new policy statement. The policy statement describes the potential future use of the agency's administrative investigation process to enhance its determinations regarding agreements filed by ocean common carriers or marine terminal operators that may present anticompetitive features under the Shipping Act.
Policy statement
The policy statement can be found at the following link:
David Eng, Secretary; Phone: (202) 523-5725; Email:
On July 30, 2024, the Commission issued a policy statement to provide guidance about the agency's potential future use of its administrative investigation process to enhance its determinations regarding agreements filed by ocean common carriers or marine terminal operators that may present anticompetitive features.
As the policy statement explains, such an administrative process can aid in the Commission's competition analysis and enable it to present a more comprehensive, well-supported determination in any later court proceeding seeking injunctive relief under 46 U.S.C. 41307(b). This process would occur under 46 U.S.C. 41302-04 and applicable FMC regulations.
The policy statement can be found at the following link:
This document is issued under authority of 5 U.S.C. 552 and 46 U.S.C. 41302-04, 41307(b).
By the Commission.
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Wireline Competition Bureau (Bureau) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's revised Numbering Authorization Application rules. This document is consistent with
The amendments to 47 CFR 52.15(g)(3)(ii)(B) through (F), (I), (K), (L), and (N) and (g)(3)(x)(A) (amendatory instruction 3), published at 88 FR 80617, November 20, 2023, are effective on August 8, 2024.
Jordan Reth, Competition Policy Division, Wireline Competition Bureau, at (202) 418-1418, or email:
On September 21, 2023, the Commission adopted
On April 19, 2024, OMB approved, for a period of three years, the information collection requirements relating to the Numbering Authorization Application rules contained in the
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Bureau is notifying the public that it received final OMB approval on April 19, 2024, for the information collection requirements contained in the modifications to the Commission's direct access authorization rules in 47 CFR part 52.
Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number.
The foregoing notification is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the affected respondents are as follows:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain MD Helicopters, LLC (MDHI), Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters. This proposed AD was prompted by a report of a seized and damaged roller bearing in the pilot interconnecting cyclic torque tube (torque tube) assembly. This proposed AD would require repetitively inspecting the torque tube assembly for corrosion and cracks and the roller bearings for corrosion and degradation. This proposed AD would also require repetitively inspecting the torque tube assembly for freedom-of-movement. Depending on the results, this proposed AD would require replacing parts or accomplishing additional inspections. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 23, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
Eduardo Orozco-Duran, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone: (562) 627-5264; 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 Eduardo Orozco-Duran, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone: (562) 627-5264; email:
The FAA received a report of a seized and damaged roller bearing assembly in the torque tube assembly of an MDHI Model MD369E helicopter. This damage did not allow the torque tube to rotate as designed, which initiated a crack and resulted in an emergency landing. The seized roller bearings were due to rust compounded with dried grease residue and an aggressive chemical environment. Because the seized roller bearings did not allow the torque tube to rotate freely, additional torsional stresses occurred on the torque tube, causing a crack to initiate and eventually propagate until the part failed and longitudinal control was lost. Since MDHI Model 369, 369A, 369D, 369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters have the same torque tube assembly installed, they are also affected by this unsafe condition.
Accordingly, this proposed AD would require repetitively visually inspecting the torque tube for corrosion and cracks, repetitively visually inspecting the roller bearings for corrosion and degradation, performing a repetitive freedom-of-movement inspection of the torque tube assembly for binding or ratcheting, and corrective or additional action as necessary. This condition, if not addressed, could result in reduced controllability and subsequent loss of control of the helicopter.
The FAA is issuing this NPRM after determining that the unsafe condition
This proposed AD would require repetitive visual inspections of the torque tube assembly for cracks and corrosion and the roller bearings for corrosion and degradation. This proposed AD would also require repetitively inspecting the freedom of movement of the torque tube assembly for binding and ratcheting. Depending on the results, this proposed AD would require replacing parts or accomplishing additional inspections.
The FAA estimates that this AD, if adopted as proposed, would affect 353 helicopters of U.S. registry. The FAA estimates the following costs to comply with this proposed AD. Labor costs are estimated at $85 per work-hour.
Visually inspecting the torque tube and roller bearings would take approximately 1 work-hour for an estimated cost of $85 per helicopter and $30,005 for the U.S. fleet, per inspection cycle. Inspecting the torque tube assembly for freedom of movement would take approximately 0.75 work-hour for an estimated cost of $64 per helicopter and $22,595 for U.S fleet cost, per inspection cycle. If required, a more in-depth inspection of the roller bearings would take approximately 0.25 work-hour for an estimated cost of $21 per helicopter, per instance.
If required, replacing a torque tube would take approximately 6 work-hours and parts would cost approximately $4,773 for an estimated cost of $5,283 per torque tube replacement. Replacing a roller bearing would take approximately 6 work-hours and parts would cost approximately $210 for an estimated cost of $720 per roller bearing replacement.
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 September 23, 2024.
None.
This AD applies to MD Helicopters, LLC, Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters, certificated in any category, with a pilot interconnecting cyclic torque tube (torque tube) part number 369H7133-7 installed.
Joint Aircraft System Component (JASC) Code 6700, Rotorcraft Flight Control.
This AD was prompted by a report of a seized and damaged roller bearing in the torque tube assembly. The FAA is issuing this AD to prevent failure of the torque tube assembly. The unsafe condition, if not addressed, could result in reduced controllability and subsequent loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 100 hours time-in-service (TIS) or within one year after the effective date of this AD, whichever occurs first, and thereafter at intervals not to exceed 100 hours TIS, accomplish the actions required by paragraphs (g)(1)(i) and (ii) of this AD.
(i) Using a flashlight and mirror, visually inspect the torque tube for corrosion and cracks. If there is any corrosion or a crack, before further flight, remove the torque tube from service and install an airworthy torque tube.
(ii) Visually inspect each roller bearing (number 5) as depicted in Figure 1 to paragraph (g)(1) of this AD for corrosion and degradation. If a roller bearing has any corrosion or degradation, before further flight, remove the roller bearing from service and install an airworthy roller bearing.
(2) Before the helicopter accumulates 3,000 total hours TIS or within 100 hours TIS after the effective date of this AD, whichever occurs later, and thereafter at intervals not to exceed 100 hours TIS, perform a freedom-of movement inspection on the torque tube assembly by accomplishing the actions required by paragraphs (g)(2)(i) through (v) of this AD.
(i) Disconnect the one-way lock (number 6) of the torque tube by removing the cotter pin (number 7), nut (number 8), bolt (number 9), washers (number 10), and slotted bushing (number 11) from the torque tube assembly as depicted in Figure 1 to paragraph (g)(1) of this AD.
(ii) Loosen the longitudinal cyclic friction knob (number 12 or 13) of the torque tube assembly as depicted in Figure 1 to paragraph (g)(1) of this AD.
(iii) While moving the cyclic control forward and aft to allow the torque tube assembly to rotate through its full range of motion, inspect the torque tube assembly for binding and ratcheting.
(A) If there is any binding or ratcheting as a result of the action required by paragraph (g)(2)(iii) of this AD, before further flight, inspect each roller bearing (number 5) as depicted in Figure 1 to paragraph (g)(1) of this AD for damage. For the purposes of this inspection, damage may be indicated by corrosion, lack of lubrication (dry exterior surface), or material degradation.
(B) If any roller bearing (number 5) as depicted in Figure 1 to paragraph (g)(1) of this AD has any damage, before further flight, remove the roller bearing from service and install an airworthy roller bearing.
(iv) If there is not any binding or ratcheting as a result of the action required by
(v) Connect the one-way lock (number 6) as depicted in Figure 1 to paragraph (g)(1) of this AD by accomplishing the actions required by paragraphs (g)(2)(v)(A) and (B).
(A) Install the slotted bushing (number 11), washers (number 10), bolt (number 9), nut (number 8), and new (zero total hours TIS) cotter pin (number 7) as depicted in Figure 1 to paragraph (g)(1) of this AD.
(B) Ensure the edge of the slotted bushing (number 11) protrudes 0.010 to 0.080 inch (0.25 to 2.03 mm) above the surface of the cyclic torque tube after the nut is tightened.
(1) The Manager, West Certification Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the West Certification Branch, send it to the attention of the person identified in paragraph (i) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Eduardo Orozco-Duran, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone: (562) 627-5264; email:
None.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD was prompted by the discovery of ten ultrasonic inspections associated with airworthiness limitations (AWL) tasks and structural deviation inspection requirements (SDIR) tasks potentially not detecting cracks. This proposed AD would require repetitive ultrasonic inspections of certain structural areas for cracking as specified in a Transport Canada AD, which is proposed for incorporation by reference (IBR), and repair of cracking, as applicable. This proposed AD would also prohibit use of the previous revisions of certain procedures and mandate the use of the revised procedures when performing the inspections required by the associated AWL and SDIR tasks. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by September 23, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
• For Transport Canada material in this proposed AD, contact Transport Canada, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-3639; 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.
Yaser Osman, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-7300; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
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
Transport Canada, which is the aviation authority for Canada, has issued Transport Canada AD CF-2023-74, dated November 21, 2023 (Transport Canada AD CF-2023-74) (also referred to as the MCAI), to correct an unsafe condition for all MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states MHI RJ Aviation ULC discovered ten ultrasound (
The FAA is proposing this AD to address undetected cracks in certain structural areas. The unsafe condition, if not addressed, could result in structural failure of the airplane. You may examine the MCAI in the AD docket at
Transport Canada AD CF-2023-74 specifies procedures for repetitive ultrasonic inspections of certain structural areas for cracking. The structural areas include, but are not limited to, certain lateral beam web and lower cap flanges, engine support beam cap angles, engine support beams, webs, and doublers. Transport Canada AD CF-2023-74 also prohibits the use of the previous revisions of certain ultrasonic inspection procedures specified in Part 4 of the NDTM and mandates the use of revised procedures when performing the inspections required by the associated AWL and SDIR tasks.
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 require accomplishing the actions specified in Transport Canada AD CF-2023-74 described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD, and except as discussed under “Differences Between this NPRM and the MCAI.”
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 Transport Canada AD CF-2023-74 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with Transport Canada AD CF-2023-74 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Material required by Transport Canada AD CF-2023-74 for compliance will be available at
Transport Canada AD CF-2023-74 requires repetitive inspections for cracking but does not specify accomplishing a corrective action if any cracking is found. Therefore, this proposed AD would require repairing any cracking found using a method approved by the Manager, International Validation Branch, FAA; or Transport Canada; or MHI RJ Aviation ULC's Transport Canada Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
The FAA estimates that this AD, if adopted as proposed, would affect 395 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA has received no definitive data on which to base the cost estimates for the repairs specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section
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 September 23, 2024.
None.
This AD applies to all MHI RJ Aviation ULC (Type Certificate previously held by Bombardier, Inc.) Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by the discovery of ten ultrasonic inspections associated with airworthiness limitations (AWL) tasks and structural deviation inspection requirements (SDIR) potentially not detecting cracks. The FAA is issuing this AD to address undetected cracks in certain structural areas. The unsafe condition, if not addressed, could result in structural failure 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, Transport Canada AD CF-2023-74, dated November 21, 2023 (CF-2023-74).
(1) Where Transport Canada AD CF-2023-74 refers to its effective date, this AD requires using the effective date of this AD.
(2) Where paragraph A. of Transport Canada AD CF-2023-74 specifies to perform AWL tasks and SDIR tasks, for this AD, the initial compliance time for the tasks is at the time specified in paragraph A. of Transport Canada AD CF-2023-74 or within 30 days after the effective date of this AD, whichever occurs later.
(3) Where paragraph B. of Transport Canada AD CF-2023-74 refers to phase-in compliance times in Table 1 of Transport Canada AD CF-2023-74, this AD requires using the applicable phase-in time identified in Table 1 of Transport Canada AD CF-2023-74, or within 30 days after the effective date of this AD, whichever occurs later.
(4) If, during any inspection required by paragraph (g) of this AD, any cracking is found, repair before further flight using a method approved by the Manager, International Validation Branch, FAA; or Transport Canada; or MHI RJ Aviation ULC's Transport Canada Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.
The following provisions also apply to this AD:
(1)
(2)
For more information about this AD, contact Yaser Osman, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-7300; email
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this material as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Transport Canada AD CF-2023-74, dated November 21, 2023.
(ii) [Reserved]
(3) For Transport Canada AD CF-2023-74, contact Transport Canada, Transport Canada National Aircraft Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-3639; email
(4) 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.
(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
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend domestic Very High Frequency Omnidirectional Range (VOR) Federal Airways V-16, V-103, V-375, and V-473 in the eastern United States. The FAA is taking this action due to the planned decommissioning of the Roanoke, VA (ROA), VOR/Distance Measuring Equipment (VOR/DME). This action is in support of the FAA's VOR Minimum Operational Network (MON) Program.
Comments must be received on or before September 23, 2024.
Send comments identified by FAA Docket No. FAA-2024-2031 and Airspace Docket No. 24-AEA-6 using any of the following methods:
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FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Brian Vidis, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the route structure to maintain the efficient flow of air traffic within the National Airspace System (NAS).
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
Domestic VOR Federal airways are published in paragraph 6010(a) of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is planning to decommission the Roanoke, VA (ROA), VOR/DME in June 2025. The Roanoke VOR/DME is a candidate navigational aid (NAVAID) identified for discontinuance by the FAA's VOR MON program and listed in the Final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-
The Air Traffic Service (ATS) routes affected by the planned NAVAID decommissioning are VOR Federal Airways V-16, V-103, V-375, and V-473. With the planned decommissioning of the Roanoke, VA (ROA), VOR/DME, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected ATS routes. As such, proposed modifications to V-375 and V-473 would result in the airways being shortened; and to V-16 and V-103 would result in a gap being created.
To overcome the proposed modifications to the affected routes, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways or receive air traffic control (ATC) radar vectors to fly through or circumnavigate the affected area. Additionally, IFR pilots with Area Navigation (RNAV)-equipped aircraft could also use the adjacent RNAV Routes T-315, T-424, T-426, and T-479; or navigate point-to-point using the existing fixes that will remain in place to support continued operations though the affected area. Visual flight rules (VFR) pilots who elect to navigate via airways through the affected area could also take advantage of ATC services listed previously.
The FAA is proposing an amendment to 14 CFR part 71 to amend domestic VOR Federal Airways V-16, V-103, V-375, and V-473 to support the planned decommissioning of the Roanoke, VA (ROA), VOR/DME. This action is in support of the FAA's VOR MON Program.
Additionally, the FAA proposes to add to the description that the airspace within restricted area R-5002F is excluded during its time of use as R-5002F is adjacent to VOR Federal Airway V-16 and must excluded. As amended, the airway would be changed to extend between the Los Angeles VORTAC and the Holly Springs VORTAC; between the Shelbyville VOR/DME and the Pulaski VORTAC; between the Lynchburg VOR/DME and the Richmond VORTAC; and between the Smyrna VORTAC and the CREAM Fix. The airspace within restricted areas R-5002A, R-5002C, R-5002D, and R-5002F is excluded during their times of use.
The full descriptions of the above routes are set forth below in the proposed amendments to part 71. The NAVAID radials listed in the VOR Federal airway description regulatory text of this final rule are stated in degrees True north. Additionally, minor editorial corrections to the airway descriptions are made to comply with ATS route formatting requirements.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Los Angeles, CA; Paradise, CA; Palm Springs, CA; Blythe, CA; Buckeye, AZ; Phoenix, AZ; INT Phoenix 155° and Stanfield, AZ, 105° radials; Tucson, AZ; San Simon, AZ; INT San Simon 119° and Columbus, NM, 277° radials; Columbus; El Paso, TX; Salt Flat, TX; Wink, TX; INT Wink 066° and Big Spring, TX, 260° radials; Big Spring; Abilene, TX; Bowie, TX; Bonham, TX; Paris, TX; Texarkana, AR; Pine Bluff, AR; Marvell, AR; to Holly Springs, MS. From Shelbyville, TN; Hinch Mountain, TN; Volunteer, TN; Holston Mountain, TN; to Pulaski, VA. From Lynchburg, VA; Flat Rock, VA; to Richmond, VA. From Smyrna, DE; Cedar Lake, NJ; Coyle, NJ; INT Coyle 036° and Kennedy, NY, 209° radials; Kennedy; INT Kennedy 040° and Calverton, NY, 261° radials; Calverton; to INT Calverton 044° and Madison, CT, 142° radials. The airspace within Mexico and the airspace below 2,000 feet MSL outside the United States is excluded. The airspace within Restricted Areas R-5002A, R-5002C, R-5002D, and R-5002F is excluded during their times of use.
From Chesterfield, SC; Greensboro, NC; to INT of Greensboro 357° T/360° M and South Boston, VA, 247° T/252° M radials. From Elkins, WV; Clarksburg, WV; Bellaire, OH; INT Bellaire 327° and Akron, OH, 181° radials; to Akron.
From Gordonsville, VA; to INT Gordonsville 034° and Casanova, VA, 142° radials.
From Montebello, VA; to Gordonsville, VA.
Environmental Protection Agency (EPA).
Notice of filing of petition and request for comment.
This document announces the Agency's receipt of an initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before September 9, 2024.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2024-0059, through the
Madison H. Le, Biopesticides and Pollution Prevention Division (BPPD) (7511M), main telephone number: (202) 566-1400, email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
1.
2.
3.
EPA is announcing receipt of a pesticide petition filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food
Pursuant to 40 CFR 180.7(f), a summary of the petition that is the subject of this document, prepared by the petitioner, is included in a docket EPA has created for this rulemaking. The docket for this petition is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.
21 U.S.C. 346a.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) explores the use of handset unlocking policies as a means to improve consumer choice and flexibility and to enhance competition across the mobile wireless marketplace as part of the Commission's ongoing efforts to carry out its statutory obligations to ensure a competitive marketplace for mobile wireless services. Specifically, the Commission proposes to require all mobile wireless service providers to unlock handsets 60 days after a consumer's handset is activated with the provider, unless within the 60-day period the service provider determines the handset was purchased through fraud.
Interested parties may file comments on or before September 9, 2024, and reply comments on or before September 23, 2024. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, the Office of Management and Budget, and other interested parties on or before October 7, 2024. Written comments on the Initial Regulatory Flexibility Analysis (IRFA) must have a separate and distinct heading designating them as responses to the IRFA and must be submitted by the public on or before September 9, 2024.
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). You may submit comments, identified by WT Docket No. 24-186, by any of the following methods:
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•
• Filings can be sent by hand or messenger delivery, by commercial courier, or by the U.S. Postal Service. All filings must be addressed to the Secretary, Federal Communications Commission.
• Hand-delivered or messenger-delivered paper filings for the Commission's Secretary are accepted between 8 a.m. and 4 p.m. by the FCC's mailing contractor at 9050 Junction Drive, Annapolis Junction, MD 20701. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
• Commercial courier deliveries (any deliveries not by the U.S. Postal Service) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. Filings sent by U.S. Postal Service First-Class Mail, Priority Mail, and Priority Mail Express must be sent to 45 L Street NE, Washington, DC 20554.
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Eli Johnson, Attorney Advisor, Competition and Infrastructure Policy Division, Wireless Telecommunications Bureau, at 202-418-1395 or
This is a summary of the Commission's Notice of Proposed Rulemaking (
1. With the NPRM, the Commission explores the use of handset unlocking policies as a means to improve consumer choice and flexibility and to enhance competition across the mobile wireless marketplace as part of the Commission's ongoing efforts to carry out its statutory obligations to ensure a competitive marketplace for mobile wireless services. Handset unlocking, which allows consumers to take their existing handset with them when they switch from one mobile wireless service provider to another, can be an important tool in facilitating competition and reducing barriers for consumers to switch between wireless providers. Over the past two decades, the Commission has adopted handset unlocking requirements for particular providers in specific circumstances, upon finding that doing so was justified in each of those instances. In the NPRM, the Commission tentatively concludes that adopting a broadly applicable set of handset unlocking requirements for all mobile wireless service providers would serve the public interest, and we seek comment on which requirements would best facilitate competition and consumer choice. Specifically, the Commission proposes to require all mobile wireless service providers to unlock handsets 60 days after a consumer's handset is activated with the provider, unless within the 60-day period the service provider determines the handset was purchased through fraud.
2. Unlocking a handset allows consumers to take their existing handset with them when they switch from one mobile wireless service provider to another, as long as the consumer's handset is compatible with the new provider's wireless network. In some instances, handsets are sold with discounts in exchange for a required service plan commitment, often months or years in length, or pursuant to a handset financing plan. Locking software generally is intended to ensure that handsets will remain active on the network of the provider that sold the handset (with a discount or with a handset installment plan) for a certain period of time or amount of usage. A locked handset cannot be used on a competing service provider's compatible network without the handset first being unlocked. The unlocking process varies by handset and by service provider. A service provider may automatically unlock a handset after certain conditions are met, send instructions to customers on how to unlock a handset upon request, or complete the unlocking process in-store. The Commission has found that “[m]obile device unlocking facilitates consumer choice among mobile broadband providers by freeing consumers from having to replace their handset to use another network, thereby reducing switching costs.”
3. The wireless industry has established six general handset unlocking commitments as part of the CTIA Consumer Code for Wireless Service (CTIA Unlocking Commitments). Wireless service providers, such as AT&T, T-Mobile, and Verizon, who have voluntarily agreed to abide by these commitments will unlock handsets in a timely manner when they receive a request from a consumer to unlock a handset once certain conditions are met. These commitments assist consumers by enhancing transparency and disclosure of service provider locking polices. These commitments cover: (1) disclosure; (2) postpaid unlocking policy; (3) prepaid unlocking policy; (4) notice; (5) response time; and (6) deployed personnel unlocking policy. In summary, service providers who abide by these commitments unlock handsets one year after activation for prepaid, and after fulfilment of a service contract, handset financing plan, or payment of an early termination fee for postpaid.
4. In addition to the industry's voluntary unlocking standards, certain wireless service providers, as discussed below, are subject to unlocking requirements as a result of rules specific
5. Section 27.16(e) of the Commission's rules prohibits the locking of handsets that operate on the 700 MHz C Block frequency bands. Under this rule, no C Block licensee “may disable features on handsets it provides to customers, to the extent such features are compliant with the licensee's standards . . . nor configure handsets it provides to prohibit use of such handsets on other providers' networks.” The Commission adopted this rule in the 2007
6. As one of the 700 MHz C Block licensees, Verizon must comply with this requirement. In 2019, however, the Wireless Telecommunications Bureau granted Verizon a partial waiver of this unlocking requirement to better combat identity theft and other types of handset-related fraud. The waiver allows Verizon to lock handsets that operate on the 700 MHz C Block frequencies for 60 days from the date the handsets become active on its network. The Bureau found that allowing handsets to be locked for 60 days to combat handset fraud would not significantly interfere with the policy objective of enabling consumers to be able to migrate from one service provider to another on compatible networks.
7. Further, as part of the
8. As a result of these Commission-imposed unlocking conditions, Verizon, after the expiration of the initial 60-day period, must automatically unlock a customer's handset regardless of whether: (1) the customer asks for the handset to be unlocked or (2) the handset is fully paid off. With respect to the Verizon unlocking requirements, the Commission has stated that limiting handset locking periods reduces barriers to consumers being able to switch between wireless service providers.
9. Similarly, T-Mobile operates under an unlocking requirement imposed as a merger condition in connection with the
10. Further, as part of the recent
11. With the exception of these specific Government-enforced unlocking requirements, mobile wireless service providers are free to adjust their unlocking requirements, including increasing the unlocking waiting period. For instance, T-Mobile recently increased its locking period for one of its brands, Metro by T-Mobile, from 180 days to 365 days.
12. In the NPRM, we tentatively conclude that adopting a broadly applicable set of handset unlocking requirements for all mobile wireless service providers would serve the public interest, and we seek comment on which specific requirements would best facilitate competition and consumer choice. We propose to require all mobile wireless service providers to unlock handsets 60 days after a consumer's handset is activated with the provider, unless within the 60-day period the service provider determines the handset was purchased through fraud. We find that there are several factors favoring our proposed unlocking policy.
13. First, having a uniform unlocking policy increases market transparency. We recognize that the CTIA Unlocking Commitments require service providers to post on their websites their policies on postpaid and prepaid handset unlocking. Nonetheless, we tentatively conclude that imposing a uniform handset unlocking policy is likely to increase the information available to consumers, reduce possible consumer confusion, and improve consumer choice through improved information.
14. Second, the locking of handsets can pose a barrier to consumers' ability to switch service providers. Reducing the period during which a provider can lock a handset should reduce switching costs and increase a consumer's ability to change providers in response to changing market prices and service characteristics, new technology, or changes in a consumer's circumstances or needs, which should increase consumer welfare. As a result, consumers will incur fewer direct costs when they do switch and will be less likely to be deterred from switching because of the locked handset.
15. Third, by reducing switching costs and increasing consumers' ability to switch, restrictions on handset locking can increase competition among wireless providers, which can lead to lower prices, more attractive service characteristics, and improved service performance. In this regard, we note that the Commission has found that handset locking may inhibit competition by making it more difficult for consumers to switch among service providers, and, in order to encourage competition and preserve consumer choice and flexibility, it has adopted handset unlocking requirements in the context of rules for specific spectrum bands and as merger commitments. Service providers' handset unlocking practices have also been the subject of consumer complaints and inquiries received by the Commission.
16. Finally, to the extent the Commission adopts this proposal, this change would result in all wireless providers facing the same regulatory constraints, which should reduce regulatory asymmetries and result in more competitively neutral regulation.
17. We note that regulators in other countries have restricted or prohibited handset locking on the grounds that it limits consumer choice and reduces competition. For example, in 2017, the Canadian Radio-television and Telecommunication Commission (CRTC) required that all mobile wireless devices provided to consumers by wireless service providers must be unlocked, and for already locked devices, the providers were required to unlock the device upon request without charge. In adopting this requirement, the CRTC found that “[un]locked devices offer more consumer choice and convenience, contribute to a decreased risk of bill shock by providing options to consumers while travelling abroad, and reduce a significant barrier to switching wireless service providers by improving device portability.” Similarly, Ofcom, the United Kingdom's telecom regulatory agency, banned the sale of locked handsets in 2020, with the ban becoming effective in December 2021. Ofcom found,
18. Economic theory also suggests that switching costs, of which handset locking is a form, may reduce competition by locking in customers to a particular provider. Large switching costs tend to lock in buyers when they make an initial purchase, so that they are effectively buying a series of goods over time. While competition, in certain circumstances, may be efficient even in the presence of switching costs, in certain instances, it will not be efficient. For example, consumers may incur direct costs if they switch providers or they may be deterred from switching to the provider that best serves their needs at the lowest price. In addition, while high switching costs may increase a provider's incentive to compete for a customer initially, it may reduce its incentive to lower prices in subsequent periods after a customer is locked in. Thus, a consumer may enjoy lower prices during the initial period, but then have to pay higher prices in subsequent periods, or not be able to switch to a provider offering a superior service or lower price.
19. Consumer groups also support restricting handset locking. They have “long argued that `the practice of locking phones can reduce wireless competition by making it more difficult for consumers to change carriers, and by reducing the number of devices available on the secondary market.' ” For example, consumers may incur direct costs if they actually switch, and if they do not, they may not end up purchasing from their preferred provider. Consumer groups further note that “[s]maller carriers, new entrants, and [mobile virtual network operators or] MVNOs in particular may be disadvantaged in the marketplace due to a lack of handset availability.” Further, they explain that “[l]ocked phones, particularly those tied to pre-paid plans, can disadvantage low-income customers most of all, since they may not have the resources to switch carriers or purchase new phones.” In addition, in an
20. Based on the above discussion, we tentatively conclude that we should adopt a broadly applicable handset unlocking requirement for all mobile wireless service providers, and we propose to require all mobile wireless service providers to unlock handsets 60 days after a consumer's handset is activated with the provider, unless within the 60-day period the service provider determines the handset was purchased through fraud. We tentatively conclude that imposing a broadly applicable handset unlocking requirement would have a larger impact by promoting greater competitive choices for all mobile wireless subscribers. We seek comment on this view and on the importance of adopting a more broadly applicable handset unlocking requirement for promoting consumer choice and competition. Additionally, we tentatively conclude that adopting such a requirement would have the benefit of providing for uniform regulation of all mobile wireless providers.
21. More specifically, we seek comment on whether, in addition to allowing greater consumer choice, our proposal would increase competition both with respect to prepaid and postpaid service plans. We also seek comment on how our proposal might affect the incentive and ability of wireless providers to continue offering discounts on handsets, particularly in connection with extended payment plans, and lower prices on plans with minimum term commitments. We note in this regard that Verizon, which is subject to a 60-day handset unlocking requirement, continues to offer discounts on devices purchased under extended payment plans. In addition, we seek comment on how our proposed policy might affect lower-income consumers or those with poorer credit ratings. We also seek comment on other consumer impacts of the proposed unlocking requirement, including any digital equity implications. How would a 60-day device unlocking requirement impact efforts by the Commission, wireless providers, or other stakeholders to close the digital divide? Would such a requirement increase or decrease consumer access to or selection of handsets? Further, we seek comment on whether current handset locking policies have dissuaded consumers from switching providers to more competitive service offerings. Are there other practices that may hinder consumer choice when switching mobile wireless service providers that the Commission
22.
23. We seek comment on this proposal. Commenters supporting a handset unlocking rule should provide examples of how the rule should read. Our proposal includes an exception to the 60-day unlocking requirement, if during the 60-day locking period a service provider determines that a handset was purchased through fraud. We seek comment on how a service provider would determine if a handset was purchased through fraud. What criteria should the service provider use? Should the rule permit any other exceptions to deter fraud including instances where individuals or groups illegally obtain devices and resell them to the public (
24. Alternatively, should we require service providers to unlock handsets after a period shorter or longer than 60 days? For example, should we require all handsets to be unlocked by default upon activation? Or, should we require all handsets to be unlocked after the end of the handset's return period or after the first payment on the handset has been processed? Would a standardized time period of a certain number of days be easier to implement and enforce than non-standardized time periods based on return periods or billing cycles? What is the minimum amount of time service providers need to protect themselves from handset fraud? Rather than locking handsets, are there other ways service providers can protect themselves from handset fraud that would allow the Commission to prohibit the locking of handsets altogether?
25. How prevalent is handset fraud and would adopting a 60-day handset unlocking requirement be sufficient to deter fraud? How prevalent is handset trafficking and would adopting a 60-day handset unlocking requirement be sufficient to deter trafficking? Commenters that argue that handset fraud or handset trafficking is common should provide data supporting this assertion. If a wireless service provider determines that a handset has been fraudulently purchased, can the service provider remotely lock the handset at issue or deactivate the handset so it will no longer operate on the provider's network or any other wireless network? Do the security features of smartphones sold today include adequate protection against theft so that service providers no longer need to lock the handset to prevent theft or trafficking? For example, could a service provider remotely lock or deactivate a handset if it determined that it was obtained fraudulently or stolen? More generally, are there other ways service providers could protect against fraud or trafficking that would not involve handset locking? Could a criminal override any of these alternative methods of fraud or trafficking prevention?
26.
27. We also seek comment on the impact of a 60-day unlocking requirement in connection with service providers' incentives to offer discounted handsets for postpaid and prepaid service plans. Verizon, for example, suggests that providers may rely on handset locking to sustain their ability to offer handset subsidies and that such subsidies may be particularly important in prepaid environments. Public interest groups, on the other hand, argue that locked handsets tied to prepaid plans can disadvantage low-income customers most of all since they may not have the resources to switch service providers or purchase new handsets. They also note that unlocked handsets “facilitate a robust secondary market for used devices, providing consumers with more affordable options.” We seek comment on these arguments. We also seek comment on the impact of a 60-day unlocking requirement on the incentive and ability of a provider to offer term contracts at discounts.
28. What factors should the Commission consider in determining how best to balance the needs of service providers to ensure that they are reimbursed for the handsets that they have subsidized and the needs of consumers with locked handsets to be able to take their handsets to another mobile wireless service provider? Given that a 60-day unlocking requirement already applies to Verizon and Verizon continues to remain competitive in the marketplace, we anticipate that a rule requiring unlocking after a 60-day period would maintain provider incentives to offer handset subsidies while reducing barriers for consumers to switch among service providers. We seek comment on this view. Do commenters agree with arguments that such a requirement would benefit smaller providers, new entrants, and MVNOs, by increasing the number of handsets available on the secondary market? Would it help consumers by providing them with more affordable handset options? Should the Commission consider adopting a different handset unlocking rule for prepaid and postpaid handsets?
29.
30. Should we also require that mobile wireless service providers transition to provide for automatic unlocking of all new handsets that they offer? The Commission adopted such a requirement as part of the handset unlocking conditions imposed in the Verizon/TracFone and the T-Mobile-Mint Mobile/Ultra Mobile transactions. In those cases, Verizon and T-Mobile, respectively, were required to commit to ensuring that all new handsets activated on their network would be capable of automatic unlocking after a two-year period. If we adopt a handset unlocking requirement generally for all mobile wireless service providers, should we also require them to ensure that, after a two-year period, all new handsets activated on their networks will be capable of automatic unlocking? If so, would automatic unlocking be accomplished through a software push to a handset or is there another way to accomplish automatic unlocking? We seek comment on whether there are any technical or other implementation issues associated with such an approach and whether these implementation issues might be different for small or rural service providers.
31. Further, we seek comment on how customers should be informed about a service provider's unlocking policies and whether we should require service providers to notify their customers when their handset locking period has ended or when their handsets have been automatically unlocked. Along these lines, should we require service providers to post on their websites their unlocking policies? Should we also adopt a requirement that the unlocking policy be expressed using clear and easy to understand language? In addition to requiring service providers to post their unlocking policies on their websites, should we require service providers to post their unlocking policies in their stores and that store employees be available to explain the service provider's unlocking policies to customers at the time they purchase handsets? How do we ensure that service providers fully disclose to their customers their unlocking policies at the time a customer purchases a handset? Further, should we require service providers to notify their customers when their handsets are ready to be unlocked or that their handsets have been automatically unlocked? For instance, should we require service providers to send a text message to a customer's handset when the locking period for the handset has expired or when the customer's handset has been automatically unlocked? Should we also require that the service provider contact the customer by email or by a letter sent to the customer's billing address? How do we ensure that service providers fully disclose their unlocking policies to their customers and that customers are aware that the locking period for their handsets has ended or that their handsets have been automatically unlocked?
32.
33. We tentatively conclude that title III also would permit the Commission to more broadly require unlocking of handsets for all mobile wireless service providers. For example, section 303(b) directs the Commission, as required by the public interest, to “[p]rescribe the nature of the service to be rendered by each class of licensed stations and each station within any class.” Section 303(g) authorizes the Commission to “generally encourage the larger and more effective use of radio in the public interest.” Section 303(r) provides the Commission authority to “make such rules and regulations and prescribe such restrictions and conditions, not inconsistent with law, as may be necessary to carry out the provisions of [the Act].” In addition, section 316 authorizes the Commission to adopt new conditions on existing licenses if it determines that such action “will promote the public interest, convenience, and necessity.”
34. We propose to rely on this authority to require mobile wireless service providers to unlock handsets. Our proposal to require unlocking of handsets would prescribe the nature of service that a mobile wireless service provider must offer when providing mobile wireless services. By giving consumers greater freedom to switch between mobile wireless service providers, the proposed requirement would serve the public interest and help the Commission meet its responsibility to ensure the availability of communications services. We tentatively conclude that such requirements would also be supported by section 332(c)(1) and provisions of title II, which require common carriers' practices to be “just and reasonable,” and prohibit and authorize the Commission to “prescribe rules and regulations as may be necessary in the public interest to carry out the provisions of [the Act.]” We seek comment on this analysis and on other sources of authority for handset unlocking requirements.
35.
36. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Federal Communications Commission (Commission) has prepared the Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies proposed in the Notice of Proposed Rulemaking (NPRM). The Commission requests written public comments on the IRFA. Comments must
37. In the
38. The proposed action is authorized pursuant to sections 1, 4(i), 4(j), 303, and 316 of the Communications Act of 1934, as amended; 47 U.S.C. 151, 154(i), 154(j),303, and 316.
39. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small-business concern” under the Small Business Act. A “small-business concern” is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
40.
41. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements
42. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicate there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number, there were 36,931 general purpose governments (county, municipal, and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, we estimate that at least 48,971 entities fall into the category of “small governmental jurisdictions.”
43.
44.
45.
46.
47.
48. The
49. If the Commission ultimately decides to adopt its proposed approach, this could potentially result in additional costs, new or modified recordkeeping, reporting, or other compliance requirements for small and other providers. For example, new handset unlocking rules may require wireless service providers to unlock handsets 60 days after a consumer initiates service with the provider. New handset unlocking rules may also require that mobile wireless service providers provide automatic unlocking for those handsets that can be unlocked automatically and that they transition to being able to automatically unlock all handsets that they offer for sale to consumers. The
50. At present, the record does not include a detailed cost/benefit analysis that would allow us to quantify the costs of compliance for small entities, including whether it will be necessary for small entities to hire professionals to comply with any rules that may be adopted. Small and other entities are encouraged to quantify the costs and benefits of any reporting, recordkeeping, or compliance requirement that may be established in this proceeding. The Commission expects the comments it receives on its proposals, and the matters discussed in the
51. The RFA requires an agency to provide, “a description of the steps the agency has taken to minimize the significant economic impact on small entities . . . including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.”
52. The
53. The Commission expects to consider more fully the economic impact on small entities following its review of comments filed in response to the
54. None.
55. Accordingly,
56.
57.
Federal Communications Commission.
Proposed rule.
The Video Division, Media Bureau (Bureau), has before it a Joint Petition for Rulemaking filed May 21, 2024, by Gray Television Licensee, LLC (Gray), the licensee of KCBD, Lubbock, Texas (KCBD), which is operating on channel 11 but previously held a construction permit for channel 36, and SagamoreHill of Lubbock, LLC (SagamoreHill), the licensee of KJTV-TV, channel 35, Lubbock, Texas (KJTV-TV). As discussed below, Gray and SagamoreHill request that the Bureau amend the Table of TV Allotments to permit the stations to “swap” channels and authorize KCBD to operate on channel 35 and KJTV-TV to operate on channel 11. Accordingly, we seek comment on substituting channel 11 for channel 35 and channel 35 for channel 36 at Lubbock, Texas (Lubbock).
Comments must be filed on or before September 9, 2024 and reply comments on or before September 23, 2024.
Federal Communications Commission, Office of the Secretary, 45 L Street NE, Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve counsel for the Joint Petitioner as follows: Joan Stewart, Esq., Wiley Rein, LLP, 2050 M Street NW, Washington, DC 20036 and Scott Woodworth, Esq., Edinger Associates PLLC, 1725 I Street, Ste. 300, Washington, DC 20006.
Joyce Bernstein, Video Division, Media Bureau, (202) 418-1647, at
In 2021, at Gray's request, the Bureau amended the Table of TV Allotments to substitute UHF channel 36 for VHF channel 11 at Lubbock. Accordingly, channel 11 is no longer allotted to Lubbock in the Table of TV Allotments. Gray requested and was granted a construction permit to modify KCBD's facility to operate on channel 36 at Lubbock, using the existing broadband antenna currently used by KJTV-TV that is mounted on a tower located 5.5 kilometers from the licensed KCBD channel 11 site. Gray did not construct the facility. The Joint Petitioners now propose to “swap” the licensed channels and equipment for KCBD (channel 11) and KJTV-TV (channel 35). In order to effectuate this proposal, the Bureau must: (1) amend the Table of TV Allotments to substitute channel 11 at Lubbock for channel 35 and (2) amend the Table of TV Allotments to substitute channel 35 at Lubbock for channel 36. Upon grant of the proposed channel substitutions, the Joint Petitioners must simultaneously implement their proposed channel substitutions.
According to the Joint Petitioners, this proposal will serve the public interest because it will allow SagamoreHill to replace KJTV-TV's failing equipment with the equipment currently used by KCBD on channel 11. Specifically, Joint Petitioners state that KJTV-TV's tube transmitter is failing, that replacement parts for tube transmitters are not available, and that the cost for SagamoreHill to replace the transmitter for KJTV-TV's 1000 kW facility is prohibitively expensive. KCBD's channel 11 equipment, however, “is in good operating condition.” According to the Joint Petitioners, because Gray had planned to invest in a new 1000 kW transmitter for KCBD on channel 36, it will be able to use the new transmitter to instead replace the failing channel 35 transmitter and operate KCBD on channel 35. In turn, Gray will provide SagamoreHill with its channel 11 equipment (
We believe that Joint Petitioners' proposal warrants consideration. We believe channel 11 can be substituted for channel 35 at Lubbock, as proposed, in compliance with the principal community coverage requirements of § 73.618(a) of the Commission's rules (Rules), at coordinates 33°-32′-29.9″ N and 101°-50′-13.6″ W. In addition, we find that this channel change meets the technical requirements set forth in § 73.622(a) of the Rules. Furthermore, the proposed channel substitution would not cause any loss of service to viewers of KJTV-TV, would increase the population served within KJTV-TV's NLSC, and would provide KJTV-TV with access to better and more functional equipment.
This is a synopsis of the Commission's
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
Members of the public should note that all
Television.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:
47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.
(j) * * *
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose to list the Long Valley speckled dace (
We will accept comments received or postmarked on or before October 7, 2024. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Justin Barrett, Deputy Field Supervisor, Reno Fish and Wildlife Office, U.S. Fish and Wildlife Service, 1340 Financial Boulevard, Suite 234, Reno, NV 89502; telephone 775-861-6338. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. Please see Docket No. FWS-R8-ES-2021-0065 on
Section 4(a)(3) of the Act requires the Secretary of the Interior (Secretary), to the maximum extent prudent and determinable, concurrently with listing designate critical habitat for the species. Section 3(5)(A) of the Act defines critical habitat as (i) the specific areas within the geographical area occupied by the species, at the time it is listed, on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination by the Secretary that such areas are essential for the conservation of the species. Section 4(b)(2) of the Act states that the Secretary must make the designation on the basis of the best scientific data available and after taking into consideration the economic impact, the impact on national security, and any other relevant impacts of specifying any particular area as critical habitat.
We determined that designating critical habitat for the Long Valley speckled dace is prudent but not determinable at this time. We will coordinate with partners to obtain data sufficient to perform the required analysis of the impacts to inform our proposed critical habitat designation. When critical habitat is not determinable, the Act allows the Service an additional year to publish a critical habitat designation (16 U.S.C. 1533(b)(6)(C)(ii)).
We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:
(1) The Long Valley speckled dace's biology, range, and population trends, including:
(a) Biological or ecological requirements of the subspecies, including habitat requirements for feeding, breeding, and sheltering;
(b) Genetics and taxonomy;
(c) Historical and current range, including distribution patterns and the locations of any additional populations of this subspecies;
(d) Historical and current population levels, and current and projected trends; and
(e) Past and ongoing conservation measures for the subspecies, its habitat, or both.
(2) Threats and conservation actions affecting the subspecies, including:
(a) Factors that may be affecting the continued existence of the subspecies, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors;
(b) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this subspecies; and
(c) Existing regulations or conservation actions that may be addressing threats to this subspecies.
(3) Additional information concerning the historical and current status of this subspecies.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made solely on the basis of the best scientific and commercial data available.
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we
Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), we may conclude that the Long Valley speckled dace is threatened instead of endangered, or we may conclude that the subspecies does not warrant listing as either an endangered species or a threatened species. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.
Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in
On June 24, 2020, the Service received a petition, dated June 8, 2020, from the Center for Biological Diversity (CBD) requesting that the Long Valley speckled dace and two other speckled dace entities in the Death Valley region be listed as endangered or threatened species and critical habitat be designated under the Act. On September 29, 2021, we published in the
A species status assessment (SSA) team prepared an SSA report for the Long Valley speckled dace (Service 2023, entire). The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.
In accordance with our joint policy on peer review published in the
As discussed above in Peer Review, we received comments from four peer reviewers on the draft SSA report. We reviewed all comments for substantive issues and new information regarding the material contained in the SSA report. Reviewers generally provided additional references, clarifications, and suggestions for the SSA report. We updated the SSA report based on the information we received and worked with researchers to update the current and future condition analyses. Peer reviewer comments are addressed in the following summary, and information provided was incorporated into the SSA report as appropriate (Service 2023, entire).
A thorough review of the taxonomy, life history, and ecology of the Long Valley speckled dace is presented in the SSA report (Service 2023, pp. 6-8).
The Long Valley speckled dace is a small freshwater fish with one remaining historical population within the 700,000 year old Long Valley volcanic caldera and one refugium population in Mono County, California. The subspecies previously occupied habitat in the Owens Basin in California ranging from cold-water streams to hot springs with water temperatures typically below 29 degrees Celsius (°C) (84.2 degrees Fahrenheit (°F)) (Moyle et al. 2015, p. 3). This subspecies was found in 7 historical sites, including 6 spring sites and one small stream. While the stream population suggests the subspecies is capable of surviving in stream habitats, its disappearance from the historical stream location following development of a hydrologically-connected spring suggested the stream population relied on recruitment from spring-dwelling individuals (Sada 1989, p. 13). Population collapses in six historical sites that were modified and invaded by nonnative fish species indicates that the Long Valley speckled dace is highly susceptible to changes in its habitat. The remaining occupied habitat includes two populations: one native population at Whitmore Marsh and one translocated population at the three sites in O'Harrel Canyon Creek. The CDFW also maintains a refugium population in an artificial pond at the WMRC.
The Long Valley speckled dace is a small minnow that typically measures less than 8 centimeters (cm) but can reach 11 cm standard length. This subspecies is distinguished by its small downfacing mouth, a thick caudal peduncle, small scales, and a pointed snout. The snout typically has a small barbel on each end of the maxilla (jaw) and a small patch of skin connects the snout to the upper lip. Adults usually have eight rays in their dorsal fin, which originates behind the beginning of the pelvic fins, whereas the anal fin has six to eight rays. Distinctive dark spots on the sides and upper parts of the body, as well as a dark lateral band running to the snout, usually occur once the fish becomes larger than 3 cm. The body is
The Long Valley speckled dace is a minnow (family =
There is little information regarding the biology and life history of Long Valley speckled dace; therefore, the following description is based primarily on information for general speckled dace (
General speckled dace's subterminal mouth and tooth structure make it ideal for consumption of small aquatic invertebrates most common in riffles (hydropsychid caddisflies, baetid mayflies, and chironomid and simuliid midges). Invertebrates generally make up the bulk of their diet; however, they may also eat filamentous algae (Moyle et al. 2015, p. 2). Speckled dace forage opportunistically, which varies their diet of invertebrates depending on available food sources that may change during the seasons. Speckled dace can be active both in the day and at night, with water temperatures influencing their level of activity. Speckled dace are active year-round when stream temperatures stay above 4 °C (39.2 °F).
Long Valley speckled dace likely originated during the late Pleistocene pluvial period when they colonized the upper Owens Valley region from Mono Lake Basin water that spilled into the Adobe Valley. The Adobe Valley drained into the Owens River and fish presumably swam upstream to Long Valley. The Owens River eventually down-vaulted and formed steep waterfalls in the gorge around 100,000 years ago, ultimately isolating Long Valley from Owens Valley. Long Valley speckled dace currently have limited ability to disperse between populations, as many of the springs they occupied historically are not hydrologically connected to other lakes or streams in the broader Death Valley region or are separated by unsuitable habitat.
Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. On April 5, 2024, jointly with the National Marine Fisheries Service, we issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and what criteria we apply when designating listed species' critical habitat (89 FR 24300). On the same day, we published a final rule revising our protections for endangered species and threatened species at 50 CFR 17 (89 FR 23919). These final rules are now in effect and are incorporated into the current regulations.
The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:
(A) The present or threatened destruction, modification, or curtailment of its habitat or range;
(B) Overutilization for commercial, recreational, scientific, or educational purposes;
(C) Disease or predation;
(D) The inadequacy of existing regulatory mechanisms; or
(E) Other natural or manmade factors affecting its continued existence.
These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.
We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.
However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species.
The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis, which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at
The foreseeable future extends as far into the future as the U.S. Fish and Wildlife Service and National Marine Fisheries Service (hereafter, the Services) can make reasonably reliable predictions about the threats to the species and the species' responses to those threats. We need not identify the foreseeable future in terms of a specific period of time. We will describe the foreseeable future on a case-by-case basis, using the best available data and taking into account considerations such as the species' life-history characteristics, threat projection timeframes, and environmental variability. In other words, the foreseeable future is the period of time over which we can make reasonably reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.
The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be proposed for listing as an endangered or threatened species under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies.
To assess the Long Valley speckled dace's viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy is the ability of the species to withstand catastrophic events (for example, droughts, large pollution events); and representation is the ability of the species to adapt to both near-term and long-term changes in its physical and biological environment (for example, climate conditions, pathogens). In general, species viability will increase with increases in resiliency, redundancy, and representation (Smith et al. 2018, p. 306). Using these principles, we identified the Long Valley speckled dace's ecological requirements for survival and reproduction at the individual, population, and subspecies levels, and described the beneficial and risk factors influencing the subspecies' viability.
The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual subspecies' life-history needs. The next stage involved an assessment of the historical and current condition of the subspecies' demographics and habitat characteristics, including an explanation of how the subspecies arrived at its current condition. The final stage of the SSA involved making predictions about the subspecies' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of the subspecies to sustain populations in the wild over time, which we then used to inform our regulatory decision.
The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket No. FWS-R8-ES-2021-0065 on
In this discussion, we review the biological condition of the subspecies and its resources, and the threats that influence the subspecies' current and future condition, in order to assess the subspecies' overall viability and the risks to that viability.
For Long Valley speckled dace to have high viability, the subspecies needs to maintain its representation (adaptive capacity) by having multiple, sufficiently resilient populations (redundancy). Long Valley speckled dace is a narrow endemic and inherently has low redundancy; however, it is still important that multiple, adequately resilient populations exist throughout its range. This allows the subspecies to retain some redundancy and representation, which help mitigate impacts from threats and stochastic events. Having multiple populations helps maintain genetic diversity and adaptive capacity, which is increasingly important due to the impacts of climate change.
To have high viability, the Long Valley speckled dace would need consistent clean cold water (water temperatures that stay below 29 °C (84.2 °F) in the summer months) with access to aquatic invertebrates as a food source. Fertilized eggs and larvae utilize gravel substrates during development, and later larvae use rocks and emergent vegetation for cover. Adults typically inhabit springs but have also existed in creek systems. Populations need abundant individuals within habitat patches of adequate quality to maintain survival and reproduction despite disturbance. For Long Valley speckled dace, this revolves around having adequate aquifer-fed thermal spring systems or creeks that stay above 4 °C (39.2 °F). Having enough water in each spring or creek is important to allow dace within the population to disperse throughout the connected habitat during different seasons for reproductive purposes. Having multiple populations connected within the watershed is important to mitigate impacts from localized threats. Population size varies greatly based on the annual conditions of the habitat and will rebound in numbers when conditions are favorable.
The amount of habitat is mainly driven by snowmelt from the Sierra Nevada highlands on the western edge of the caldera (U.S. Geological Survey, undated). The subspecies inhabits a relatively small area, making adequate amounts of suitable habitat important for the resiliency of the subspecies. Quality of habitat revolves around water quality. For the subspecies, the water quality priorities are having water temperatures stay below 29 °C (84.2 °F) and limiting the amount of pollution and sedimentation in the waterways. Invasive species can also negatively impact habitat suitability directly by changing dissolved oxygen and pH levels of the water or by increasing predation and competition levels.
Capacity for population growth, particularly from low numbers, is important for the Long Valley speckled dace's resiliency. The Long Valley speckled dace currently occurs in low numbers, making it especially vulnerable to stochastic events. Having populations large enough to be self-sustaining and to be able to repopulate habitat in a highly variable and unpredictable environment is important for the Long Valley speckled dace's resiliency. In response to introduced species, disease, grazing, recreation, a trout hatchery, geothermal development, climate change, and small population size effects in the occupied habitat, Long Valley speckled dace populations must be resilient enough to repopulate habitat as environmental conditions change.
Although surveys have been completed at Whitmore Marsh as recently as 2023, the six extirpated historical sites have not been revisited as recently and assessed for current
The following discussion provides a summary of the primary factors that affect or may affect the current and future condition of the Long Valley speckled dace. For our analysis, we evaluated impacts from the following primary threats to the subspecies: (1) disease; (2) nonnative species; (3) grazing; (4) recreation; (5) water diversion; (6) geothermal development; (7) climate change; and (8) effects of small population size.
Growth and health status of fish may be negatively affected by parasites (Raissy and Ansari 2012, p. 74). In general, parasites may cause stress, reduced growth, increased risk of infection or secondary disease, and possibly death of individual fish (Hejna et al. 2023, entire). For example, in 1988, Long Valley speckled dace found in Whitmore Marsh were in poor condition due to a heavy parasite infestation of yellow grub (
The introduction of nonnative species may stress indigenous fish populations via increased predation, competitive interactions, transmission of pathogens, or hybridization (Cucherousset and Olden 2011, pp. 216-221; Mills et al. 2004, pp. 719-720). Western mosquitofish are the most common nonnative fish species that have led to the extirpation of isolated general speckled dace populations. Nonnative Lahontan tui chub (
Cattle access is known to increase bank erosion, increasing turbidity and sedimentation in the springs. Long Valley speckled dace require clear water for their spawning and clean vegetation for egg laying. Sedimentation from cattle also has the potential to fill in spring pools and runs, reducing habitat area (American Fisheries Society, undated, entire). The increased turbidity and reduced riparian vegetation lead to increased water temperatures, which reduce dissolved oxygen levels and can stress Long Valley speckled dace and increase the competitive advantage for mosquitofish. Influxes of large amounts of cattle waste increase the amount of nutrients in the water and further reduce visibility, which can impact the spawning of Long Valley speckled dace. Higher levels of nutrients result in higher biological oxygen demand and reduce the dissolved oxygen levels in the water. Increased bacterial levels may also reduce egg viability and increase the risk of infection. Grazing has been occurring in Long Valley since before the discovery of Long Valley speckled dace, and historical grazing has altered stream habitat and riparian areas, such that it is less suitable habitat for the species. While historical grazing levels may have had detrimental impacts to Long Valley speckled dace habitat, the best available information indicates that while Whitmore Marsh and Little Alkali were historically heavily impacted by cattle grazing, both populations appeared to be stable at the time grazing impacts were observed (Sada, 1989, p. 12). Grazing still occurs at low levels around Whitmore Marsh and any impacts to habitat do not appear to be adversely affecting the population there. Thus, we do not consider grazing to be a significant threat to Long Valley speckled dace populations.
Recreation activities in general may impact water quality, substrate and vegetation, and free-flowing water. The spring source that supplies Whitmore Marsh also feeds a public swimming pool. Historically, the pool has discharged lightly chlorinated water into the marsh from May to September (Cox 2023, p. 1), however chlorinated water is no longer discharged into the marsh. While the effluent from the spring is undiminished by pool operations and has maintained sufficient flows to support this Long Valley speckled dace population, the potential for an accidental spill of chlorinated water into the spring still exists. There is also potential for structural damage to the pool to result in leaks because of the age of the pool or by events such as seismic activity. Because of the proximity of the swimming pool to Whitmore Marsh we consider recreation to be a significant threat to the viability of this population.
Surface water diversions have the potential to affect fish survival directly or indirectly. Water diversions reduce the amount of water available to stream resources and return the remaining water far from the intake. Flow alterations directly impact fish by blocking migration routes (
Prior to geothermal development of a particular area, the flow path of water underneath the land surface is usually not known with sufficient detail to understand and prevent surface impacts that may be caused by such development (Sorey 2000, p. 705). Changes associated with surface expression of thermal waters from geothermal production are common and are expected. Typical changes seen in geothermal fields across the globe include, but are not limited to, changes in water temperature, flow, and quality (Bonte et al. 2011, pp. 4-8; Chen et al.
Changes in surface-expressed water temperature and flow from geothermal production areas have been documented within the Long Valley Caldera at historical localities where Long Valley speckled dace previously occurred and near the remaining population of the subspecies (Sorey 2000, entire). Geothermal pumping between 1985-1998 at Casa Diablo Geothermal Plant, part of Ormat Technologies, Inc., Mammoth Geothermal Complex, resulted in flow ceasing at Colton Spring and declines in water level at Hot Bubbling Pool (Sorey 2000, p. 706), which are located roughly 6.4 kilometers (km) (4 miles (mi)) and 4.8 km (3 mi) from Whitmore Marsh, respectively. Based on historical operations of the Casa Diablo Geothermal Plant and surface water monitoring at Whitmore Marsh, the remaining historical population of Long Valley speckled dace is outside of the range where detectable changes in surface features have occurred. However, the Casa Diablo-IV power plant that was put into service in 2022 nearly doubles the capacity of the geothermal facility, and future impacts from the operation of the expanded plant may extend farther into the Long Valley speckled dace's range. The doubled capacity plant has only been in service since July 2022. Monitoring of spring flow, temperature, and stage is not taking place at Whitmore Marsh, so the data required for an analysis of the condition of, or possible effects from local geothermal development to, the springs and surface water there are currently not available. Additionally, if the operation does cause effects to the geothermally sourced springs at Whitmore Marsh, propagation and expression of those effects may take time. Therefore, the best available information used to consider the impacts of geothermal development does not indicate that it is currently a threat to the species; however, we recognize the potential for population-level impacts should the effects of groundwater and geothermal extraction be realized at Whitmore Marsh.
Changes in climate, such as increasing temperatures, shifts in precipitation patterns, drought, and increases in wildfire have already been observed in California where Long Valley speckled dace occur, and such changes are expected to continue. Current climate change forecasts for terrestrial areas in the Northern Hemisphere predict warmer air temperatures, more intense precipitation events (both drought and flooding), and increased summer continental drying by the year 2100 (Intergovernmental Panel on Climate Change (IPCC) 2014, entire). Little is known about how and when spring flows may be affected by changes in climate. Direct hydrological connections have not been established in most cases, and for many areas, these connections remain difficult to make. Increased variations in temperature and precipitation in the range of the Long Valley speckled dace may result in effects on the life history of the subspecies. Thermal springs that comprise a major part of Long Valley are fed by aquifers dependent on snowmelt for recharge. Long Valley speckled dace are currently found in a hot-spring-fed marsh and a creek, with temperatures that stay below 29 °C (84.2 °F). Long Valley speckled dace are capable of withstanding elevated water temperatures (Moyle et al. 2015, p. 11), but the lethal upper temperature limit is unknown. Fish are generally more stressed at the upper extremes of their temperature range, and although they may be able to survive, elevated temperature is an example of a stressor that may affect them through reduced disease resistance (Moyle et al. 2015, p. 11). Average annual temperatures have increased almost 1.1 °C (1.9 °F) over the last century (Garfin et al. 2014, p. 464), and an additional increase of 1.9 to 5.3 °C (3.5 to 9.5 °F) is predicted to occur by the year 2100 (Walsh et al. 2014, p. 23). In recent decades, reductions in precipitation and winter snowpack have been observed, and this pattern is expected to continue (Garfin et al. 2014, p. 465). The frequency and intensity of these reductions have increased on a global scale (IPCC 2014, p. 77), and climate change is projected to reduce surface and groundwater resources in most subtropical deserts (IPCC 2014, p. 14).
Climate change is also predicted to increase fire frequency and severity. Whitmore Marsh, O'Harrel Canyon Creek, and certain historical sites (Little Alkali and Hot Creek Springs) are located within a moderate fire hazard severity zone. Other historical sites (Unnamed Spring and Sulfur Spring) are located within a high fire hazard severity zone. In the southern California mountains, debris flows can occur in both burned and unburned terrain. Wildfires greatly increase the likelihood of debris flows within the burned area by removing vegetation and temporarily elevating soil hydrophobicity (Staley et al. 2017, entire). Excess overland flow from intense precipitation events caused by climate change may exacerbate the effects of debris flows in areas affected by wildfire. When debris flows occur, they can cause significant erosion to hillslopes and channels, resulting in large amounts of sediment being carried downstream. This excessive sediment can have profound negative impacts on local wildlife, including fish such as the Long Valley speckled dace. Wildfire also eliminates vegetation that shades the water and moderates water temperature and may further impact water transport, sediment transport, water quality, and flow regime. Burned uplands in the watersheds may affect Long Valley speckled dace habitat by producing silt-and-ash-laden runoff that can fill in pools and significantly increase turbidity of rivers. Large wildfires have caused local extirpations in isolated Long Valley speckled dace occurrences (Expert Working Group 2023, p. 23). Wildfire may impact the Long Valley speckled dace throughout its remaining range, although the location, frequency, and size of these events cannot be precisely predicted.
Increased frequency of snow drought induced by climate change may also affect the flow rates and temperatures of hydrologic features inhabited by the Long Valley speckled dace (Hatchett and McEvoy 2018, pp. 11-12). Particularly due to the historical impacts of wildfire on Long Valley speckled dace habitat, and the potential effects a single large fire could have on the remaining historical population at Whitmore Marsh, we consider climate change to pose a significant threat to the subspecies.
Historically, Long Valley speckled dace mostly occurred in small, isolated populations throughout the subspecies' range. The subspecies currently consists of a single wild population at Whitmore Marsh. Small, isolated populations are vulnerable to a number of deleterious effects, including: (1) demographic fluctuation due to random variation in birth and death rates and sex ratio; (2) environmental fluctuation in resource or habitat availability, predation, competitive interactions, and catastrophes; (3) reduction in cooperative interactions and subsequent decline in fertility and survival (
For example, small populations of Long Valley speckled dace are more
At this time, Long Valley speckled dace is not listed under the California Endangered Species Act (CESA). Due to concerns over the future viability of the last remaining historical population of Long Valley speckled dace, CDFW staff deemed it necessary to establish a refugium population in an artificial pond at the White Mountain Research Center (WMRC) outside of the native range (Cox, 2021, p. 1). This population was sourced from individuals at Whitmore Marsh and a previous refuge population known as Becky's Pond, also sourced from Whitmore Marsh, which has since been extirpated. Although the refuge population appears stable, CDFW recommends continued monitoring for disease that may have been present in source individuals from Whitmore Marsh and management of water quality and water levels to maintain this population. Monitoring the genetic health of the refuge population will also be important for understanding and managing its long-term viability. The refugium population at WMRC represents a critical component of Long Valley speckled dace conservation and has already been used in translocation efforts.
Similar efforts to mitigate threats have also been initiated for the last remaining historical population. The public swimming pool operated by the town of Mammoth Lakes historically discharged chlorinated water into Whitmore Marsh, possibly contributing to the population decline occurring around 2017 (Cox, 2023, p. 1). The town has since made changes to the way the pool is managed and operated in order to limit the risk of introducing chlorinated water into the marsh in the future. A storage tank was constructed in 2022 to store discharged pool water until it can be transported off site to a sewage treatment plant (Cox, 2023, p. 2). This effort reduces the risk of chronic release events. In addition, the town of Mammoth Lakes has been coordinating with the Service to develop a management plan to implement response actions in the event of an accidental spill.
CDFW monitored the habitat at O'Harrel Canyon Creek in 2015-2016 and determined that drought did not have an effect on the creek despite the creek's size and watershed. These factors influenced CDFW to create a plan to translocate Long Valley speckled dace and create another wild population to supplement the Whitmore Marsh population. CDFW collected 413 Long Valley speckled dace from the Whitmore Marsh Complex Northeast pond refugium population on June 30, 2022. Collected Long Valley speckled dace were transported and released at three locations within O'Harrel Canyon Creek. Monitoring of these locations in 2023 and 2024 (Buckmaster 2023, pers. comm.; Buckmaster 2024, pers. comm.) indicated survival and reproduction; however, multiple years of monitoring will be needed to determine if this population successfully establishes.
We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on the subspecies. To assess the current and future condition of the subspecies, we evaluate the effects of all the relevant factors that may be influencing the subspecies, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire subspecies, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative-effects analysis.
As mentioned previously, the Long Valley speckled dace is a narrow endemic subspecies known from seven historical sites within the Long Valley Caldera in Mono County, California. All but one of the seven historical sites are now thought to be extirpated (Moyle et al. 2015, p. 3). Because of the small spatial scale, few extant sites, limited survey data, and localized nature of the threats, we assessed the current conditions qualitatively by discussing rangewide factors affecting viability and by summarizing the available demographic and habitat information for each population. We then supplement the demographic and habitat quality data with a threats analysis for the extant wild population. We provide qualitative descriptions of the factors influencing viability and summarize these influences using a risk matrix approach to highlight major threats and their expected impacts.
Of seven known historical populations of Long Valley speckled dace, Whitmore Marsh is the sole remaining population and covers roughly 4,000-8,000 square meters (1-2 acres), based on accounts by Moyle et al. (2015, p. 3) and Geographic Information System calculations using satellite imagery of wetland vegetation over multiple years. In 2022, a population was translocated to O'Harrel Canyon Creek from the refuge population at White Mountain Research Center (Cox 2022, p. 2); however, it is uncertain whether this population will maintain viability over time.
The Long Valley speckled dace population in Whitmore Marsh was discovered in 1988 (Sada 1989, p. 10). Sada (1989, p. 11) visited this site four times between July 31 and December 12, 1988, to collect population size and habitat quality data. The habitat was supported by spring discharge that flowed through a chlorinated swimming pool owned and maintained by the Town of Mammoth Lakes on Los Angeles Department of Water and Power property. CDFW surveyed Whitmore Marsh again in 2002 and 2009, and found the population to be relatively stable. In 2011, Long Valley speckled dace were translocated from this site to a private pond (“Becky's Pond”), which was originally constructed in 2006. No population estimates were recorded at the time of the 2011 translocation. Individuals from Becky's Pond were later moved to a refuge population established at White Mountain Research Center. The Becky's Pond population
Low numbers at Whitmore Marsh over the past 7 years, including as few as two individuals being observed in 2021, have been attributed to a die-off that likely occurred in the spring of 2017. While the cause of the population crash is unknown, there are several threats in the area that may have led to the decline. One hypothesis is that an unusually heavy snowpack during the previous winter may have prevented the majority of Long Valley speckled dace from dispersing to colder reaches of the marsh. Long Valley speckled dace concentrating near the warm pool outlet stream could have also been exposed to chlorine from the public swimming pool upstream that historically discharged lightly chlorinated water into the marsh during the summer operating season. As mentioned previously, the swimming pool no longer discharges chlorinated water into the marsh. Other possible explanations for the population die-off include parasites, or unprecedented winter kill (Cox 2023, pp. 1-2). Although we do not have direct population estimates, such large decreases in the number of fish caught, suggest that the population has experienced dramatic declines that may limit its ability to persist.
O'Harrel Canyon Creek is a spring-fed creek situated at 2,083 meters (6,834 feet) of elevation in Mono County, California, near Benton Crossing. This creek originates in the Glass Mountains and terminates before reaching the Owens River. Introduced Lahontan cutthroat trout occupy the upper 0.8 km (0.5 mi) of the creek but are not found in the lower reaches that provide suitable habitat and water temperature for Long Valley speckled dace.
Monitoring efforts will be used to determine success of population establishment at O'Harrel Canyon Creek; however, heavy snowpack from the 2022/2023 winter season prevented staff members from accessing the site until later in 2023. Young of year were observed during that survey and surviving adults, including gravid females were observed in 2024. The initial success is encouraging, however more data across multiple years will be needed to determine if this population successfully establishes. Thus, the information available for these populations indicates that the overall resiliency for the Long Valley speckled dace is currently low.
Representation, or adaptive capacity, is maximized in a species with healthy populations distributed across the breadth of its evolutionary lineages and ecological niches that is capable of moving to new, suitable environments or capable of altering its physical or behavioral traits (phenotypes) to match changing environmental conditions through either plasticity or genetic change (Nicotra et al. 2015, p. 1270; Beever et al. 2016, p. 132). Although the general speckled dace complex appears to have inherent adaptive capacity, the Long Valley speckled dace's limited range, lack of dispersal opportunities, and presumed small population size likely limit this capacity for the subspecies. The wild and translocated populations of Long Valley speckled dace are not connected hydrologically, limiting any potential for dispersal in response to localized threats, as well as any ability for recolonization following catastrophic events. In addition, the lack of genetic exchange is concerning given the population decline at Whitmore Marsh that occurred in 2017. Managing genetic diversity both within the wild population and the translocated population will be critical to conservation efforts for the Long Valley speckled dace and maintenance of the subspecies' adaptive capacity.
The Long Valley speckled dace has lost roughly 83-99 percent of its historical extent of occurrence. Such a dramatic reduction in range for a narrowly distributed subspecies suggests that the Long Valley speckled dace currently has little if any redundancy to withstand the impact of the threats present within the Long Valley Caldera, which have led to extirpations of six historical populations.
The available data suggest that the remaining historical population has recently experienced a decline and may be persisting at extremely low densities relative to previous surveys. The declines observed at Whitmore Marsh are concerning because multiple threats exist on the landscape that are not part of the historical environmental variation experienced by this population. These are also the threats that likely caused impacts leading to the extirpation of six of seven historical populations of Long Valley speckled dace. The threats still posing a high risk to the subspecies' overall viability include nonnative species, recreation, water diversion, climate change, and small population size effects. Reduced abundance at the Whitmore Marsh may limit the ability of the population to withstand the synergistic effects of multiple threats and is a concern for the viability of the subspecies.
Any decrease in the resiliency of the Whitmore Marsh population places a large burden on the refuge population at the White Mountain Research Center for maintaining the viability of the subspecies. Although the population at the White Mountain Research Center appears to be currently stable, other populations in private/artificial ponds have failed (Cox 2022, p. 2), and maintaining the refuge population in more than one pond would decrease the chances of a catastrophic event affecting this entire population. Additionally, we do not know if the recently translocated population at O'Harrel Canyon Creek has survived and successfully reproduced. While translocation will likely be a key conservation action for this subspecies, evidence of successful reproduction would be required to meaningfully increase resiliency or redundancy across the subspecies' range.
As part of the SSA, we also developed several future-condition scenarios to forecast the condition of the subspecies under different projections of threats. We used our existing assessment of current habitat as the starting point for our future scenarios. We then incorporated projections of factors likely to impact the viability of the Long Valley speckled dace into the future. Although there are several factors that may influence the condition of the subspecies in the future, we focused on (1) introduced species; (2) disease; (3) grazing; (4); water diversion; (5) recreation; (6) geothermal development; (7) climate change; and (8) effects of small population size as the threats most likely to impact the Long Valley speckled dace's habitat and long-term viability. Because we determined that the current condition of the Long Valley speckled dace is consistent with an endangered species (see Determination of Long Valley Speckled Dace's Status, below), we are not presenting the results of the future scenarios in this proposed rule. Please refer to the SSA report (Service 2023, pp. 38-43) for the full analysis of future scenarios.
The Act defines the term “species” as including any subspecies of fish or wildlife or plants, and any distinct
We have determined that the Long Valley speckled dace is likely extirpated in six of seven known historical populations, with recent declines in the only known extant population possibly caused by a number of factors, including: impacts associated with a recreational swimming pool (Factor E), parasites and disease (Factor C, or unprecedented winter kill (Factor E). We anticipate that nonnative species will pose an additional threat to the persistence of the existing population (Factor C). Further, it is unknown whether the recently translocated population at O'Harrel Canyon Creek will establish and reproduce and be able to contribute to overall viability. Representation for the subspecies is low due to limited range, lack of dispersal opportunities between the remaining historic population and translocated population, and small population size. Redundancy for the Long Valley speckled dace is extremely low following the loss of historical populations.
After evaluating threats to the subspecies and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, the Long Valley speckled dace does not have sufficient resiliency, representation, and redundancy to sustain viability. Recent declines at the only known extant population at Whitmore Marsh likely limit the ability of the subspecies to persist. A catastrophic event, such as a severe storm or wildfire, affecting one or both of the populations could result in the extinction of the subspecies. Other threats that may impact the sole remaining historical population, and uncertainty over the viability of the translocated population, place the subspecies at risk of extinction. Thus, after assessing the best available information, we determine that the Long Valley speckled dace is in danger of extinction throughout all of its range.
Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. We have determined that the Long Valley speckled dace is in danger of extinction throughout all of its range and accordingly did not undertake an analysis of any significant portions of its range. Because the Long Valley speckled dace warrants listing as endangered throughout all of its range, our determination does not conflict with the decision in
Our review of the best available scientific and commercial information indicates that the Long Valley speckled dace meets the Act's definition of an endangered species. Therefore, we are proposing to list the Long Valley speckled dace as an endangered species in accordance with sections 3(6) and 4(a)(1) of the Act.
Conservation measures provided to species listed as endangered or threatened species under the Act include recognition as a listed species, planning and implementation of recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies, foreign governments, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies, including the Service, and the prohibitions against certain activities are discussed, in part, below.
The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Section 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.
The recovery planning process begins with development of a recovery outline made available to the public soon after a final listing determination. The recovery outline guides the immediate implementation of urgent recovery actions while a recovery plan is being developed. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) may be established to develop and implement recovery plans. The recovery planning process involves the identification of actions that are necessary to halt and reverse the species' decline by addressing the threats to its survival and recovery. The recovery plan identifies recovery criteria for review of when a species may be ready for reclassification from endangered to threatened (“downlisting”) or removal from protected status (“delisting”), and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery outline, draft recovery plan, final recovery plan, and any revisions will be available on our website as they are completed (
Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (
If the Long Valley speckled dace is listed, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of California would be eligible for Federal funds to implement management actions that promote the protection or recovery of the Long Valley speckled dace. Information on our grant programs that are available to aid species recovery can be found at:
Although the Long Valley speckled dace is only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for this subspecies. Additionally, we invite you to submit any new information on this subspecies whenever it becomes available and any information you may have for recovery planning purposes (see
Section 7 of the Act is titled Interagency Cooperation, and it mandates all Federal action agencies to use their existing authorities to further the conservation purposes of the Act and to ensure that their actions are not likely to jeopardize the continued existence of listed species or adversely modify critical habitat. Regulations implementing section 7 are codified at 50 CFR part 402.
Section 7(a)(2) states that each Federal action agency shall, in consultation with the Secretary, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Each Federal agency shall review its action at the earliest possible time to determine whether it may affect listed species or critical habitat. If a determination is made that the action may affect listed species or critical habitat, formal consultation is required (50 CFR 402.14(a)), unless the Service concurs in writing that the action is not likely to adversely affect listed species or critical habitat. At the end of a formal consultation, the Service issues a biological opinion, containing its determination of whether the Federal action is likely to result in jeopardy or adverse modification.
In contrast, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of critical habitat proposed to be designated for such species. Although the conference procedures are required only when an action is likely to result in jeopardy or adverse modification, action agencies may voluntarily confer with the Service on actions that may affect species proposed for listing or critical habitat proposed to be designated. In the event that the subject species is listed or the relevant critical habitat is designated, a conference opinion may be adopted as a biological opinion and serve as compliance with section 7(a)(2) of the Act.
Examples of discretionary actions for the Long Valley speckled dace that may be subject to conference and consultation procedures under section 7 of the Act are land management or other landscape-altering activities on Federal lands administered by the U.S. Forest Service and Bureau of Land Management, as well as actions on State, Tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251
The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit, or to cause to be committed any of the following acts with regard to endangered wildlife: (1) import into, or export from, the United States; (2) take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct) within the United States, within the territorial sea of the United States, or on the high seas; (3) possess, sell, deliver, carry, transport, or ship, by any means whatsoever, any such wildlife that has been taken illegally; (4) deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or (5) sell or offer for sale in interstate or foreign commerce. Certain exceptions to these prohibitions apply to employees or agents of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.
We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits for endangered wildlife are codified at 50 CFR 17.22 and general Service permitting regulations are codified at 50 CFR part 13. With regard to endangered wildlife, a permit may be issued: for scientific purposes, for enhancing the propagation or survival of the species, or for take incidental to otherwise lawful activities. The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.
Critical habitat is defined in section 3 of the Act as:
(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features
(a) Essential to the conservation of the species, and
(b) Which may require special management considerations or protection; and
(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Our regulations at 50 CFR 424.02 define the geographical area occupied by the species as an area that may generally be delineated around species' occurrences, as determined by the Secretary (
Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.
Critical habitat receives protection under section 7 of the Act through the requirement that each Federal action agency ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of designated critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation also does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Rather, designation requires that, where a landowner requests Federal agency funding or authorization for an action that may affect an area designated as critical habitat, the Federal agency consult with the Service under section 7(a)(2) of the Act. If the action may affect the listed species itself (such as for occupied critical habitat), the Federal agency would have already been required to consult with the Service even absent the designation because of the requirement to ensure that the action is not likely to jeopardize the continued existence of the species. Even if the Service were to conclude after consultation that the proposed activity is likely to result in destruction or adverse modification of the critical habitat, the Federal action agency and the landowner are not required to abandon the proposed activity, or to restore or recover the species; instead, they must implement “reasonable and prudent alternatives” to avoid destruction or adverse modification of critical habitat.
Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat).
Under the second prong of the Act's definition of critical habitat, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the
When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information from the SSA report and information developed during the listing process for the species. Additional information sources may include any generalized conservation strategy, criteria, or outline that may have been developed for the species; the recovery plan for the species; articles in peer-reviewed journals; conservation plans developed by States and counties; scientific status surveys and studies; biological assessments; other unpublished materials; or experts' opinions or personal knowledge.
Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act; (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species; and (3) the prohibitions found in section 9 of the Act. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will continue to contribute to recovery of the species. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans, or other species conservation planning efforts if new information available at the time of those planning efforts calls for a different outcome.
Our regulations at 50 CFR 424.12(a)(2) state that critical habitat is not determinable when one or both of the following situations exist:
(i) Data sufficient to perform required analyses are lacking, or
(ii) The biological needs of the species are not sufficiently well known to identify any area that meets the definition of “critical habitat.”
When critical habitat is not determinable, the Act allows the Service an additional year to publish a critical habitat designation (16 U.S.C. 1533(b)(6)(C)(ii)).
We reviewed the available information pertaining to the biological needs of the Long Valley speckled dace and habitat characteristics where this subspecies is located. A careful assessment of the economic impacts that may occur due to a critical habitat designation is still ongoing, and we are in the process of acquiring the complex information needed to perform that assessment. Therefore, due to the current lack of data sufficient to perform
We are required by E.O.s 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951, May 4, 1994), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), the President's memorandum of November 30, 2022 (Uniform Standards for Tribal Consultation; 87 FR 74479, December 5, 2022), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with federally recognized Tribes and Alaska Native Corporations (ANCs) on a government-to-government basis. In accordance with Secretary's Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We will continue to coordinate with Tribal entities throughout the rulemaking process to list the Long Valley speckled dace as an endangered species.
A complete list of references cited in this rulemaking is available on the internet at
The primary authors of this proposed rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Reno Fish and Wildlife Office.
Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, FWS proposes to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
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National Agricultural Library, Agricultural Research Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, this notice announces the intention of the Agricultural Research Service (ARS) to request an extension of a currently approved information collection, Information Collection for Document Delivery Services at the National Agricultural Library (NAL), which expires January 31, 2025.
Comments must be submitted on or before October 7, 2024.
Send comments to: USDA, ARS-NAL, Digitization and Access Branch, 10301 Baltimore Avenue, Room 305-D, Beltsville, MD 20705-2351.
Manuel Jusino, Librarian, telephone: 202-690-4051; email:
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 September 9, 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
1. Identify areas in the administration of work requirements in SNAP and in SNAP E&T program administration and access where equity issues could occur.
2. Identify and describe the data that could be used to assess access and outcomes in the areas identified in Objective 1.
3. Describe how State agencies address equity in administering work requirements in their SNAP and SNAP E&T programs.
4. Develop recommendations on how FNS should assess and measure equity in the administration of work requirements in SNAP and in SNAP E&T program administration and access.
Rural Business-Cooperative Service, USDA.
Notice.
The Rural Business-Cooperative Service (RBCS or Agency), a Rural Development (RD) agency of the United States Department of Agriculture (USDA), invites applications under the Intermediary Relending Program (IRP) for fiscal year (FY) 2025, subject to availability of funding. This Notice is being issued prior to passage of a FY 2025 appropriations act in order to allow applicants enough time to leverage financing, prepare and submit their applications, and give the Agency time to process program applications within FY 2025. Funding for FY 2024 was $10,000,000, and the amount of funding appropriated for this program for FY 2025 will not be known until Congress passes the appropriations act for FY 2025. Successful applications will be selected by the Agency for funding and subsequently awarded to the extent that funding may ultimately be made available through appropriations. All applicant are responsible for any expenses incurred in developing their application whether or not funding is appropriated in FY 2025.
The deadlines for completed applications to be received in the USDA RD State Office for quarterly funding competitions is no later than 4:30 p.m. (local time) on: First Quarter-September 30, 2024, Second Quarter—December 31, 2024, Third Quarter—March 31, 2025, and Fourth Quarter—June 30, 2025.
Applications must be submitted to the USDA RD State Office for the state where the applicant is located. Applications may be submitted in paper or electronic format to the appropriate RD State Office and must be received by 4:30 p.m. local time on the deadline date(s) to compete for available funds in the fiscal quarter. Applicants are encouraged to contact their respective RD State Office for an email contact to submit an electronic application prior to the submission deadline date(s). A list of the USDA RD State Office contacts can be found at:
Lori Pittman, Program Management Division, Business Programs, Rural Business-Cooperative Service, U.S. Department of Agriculture, 1400 Independence Avenue SW, MS 3226, Room 5160-S, Washington, DC 20250-3226,
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The Consolidated Appropriations Act, 2024, authorized set-aside funding to projects and intermediaries serving Federally recognized Indian Tribes, and for Mississippi Delta Region Counties (as determined in accordance with Pub. L. 118-42). Eligible applicants for the set-aside funds, assuming that similar set-aside funds are appropriated for Fiscal Year 2025, must demonstrate that at least 75 percent of the benefits of an approved loan in this program will assist ultimate recipients in the designated areas. Applications for any set-aside funds must be submitted to the RD State Office where the project is located by 4:30 p.m. (local time) on the following deadline dates. The deadline to submit completed applications for Federally recognized Indian Tribes and Mississippi Delta Region Counties' projects is May 31, 2025. It is possible that funds may also be appropriated by Congress for projects located in Rural Empowerment Zone/Enterprise Communities/Rural Economic Area Partnership areas. Completed applications for these projects, subject to available funding, must be submitted by July 15, 2025.
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There are no responsiveness or threshold eligibility criteria for these loans. However, not more than one loan will be approved by the Agency for an intermediary in any single fiscal year unless the additional request is from this program's set-aside funding.
Applications will not be considered for funding if they do not provide enough information to determine eligibility, are not suitable for evaluation, or are missing required elements as stated in 7 CFR 4274.340.
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The applicant documentation and forms needed for a complete application are in 7 CFR 4274.340. There are no specific formats or limitations on the number of pages required for an application narrative, and applicants may request any Agency forms and addresses from the
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(a) At the time of application, each applicant must have an active registration in the System for Award Management (SAM) before submitting its application in accordance with 2 CFR part 25. To register in SAM, entities will be required to obtain a Unique Entity Identifier (UEI). Instructions for obtaining the UEI are available at
(b) Applicants must maintain an active SAM registration, with current, accurate and complete information, at all times during which it has an active Federal award or an application under consideration by a Federal awarding agency.
(c) Applicants must ensure they complete the Financial Assistance
(d) Applicants must provide a valid UEI in its application, unless determined exempt under 2 CFR 25.110.
(e) The Agency will not make an award until the applicant has complied with all SAM requirements including providing the UEI. If an applicant has not fully complied with the requirements by the time the Agency is ready to make an award, the Agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant.
4.
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(a)
(1) Assisting rural communities recover economically through more and better market opportunities and through improved infrastructure. Applicant would receive priority points if the project is located in or serving a rural community whose economic well-being ranks in the most distressed tier (distress score of 80 or higher) of the Distressed Communities Index using the Distressed Communities Look-Up Map available at
(2) Ensuring all rural residents have equitable access to RD programs and benefits from RD funded projects. Using the Social Vulnerability Index (SVI) Look-Up Map (available at
• The project is located in or serving a community with score 0.75 or above on the SVI;
• The applicant is a Federally recognized Indian Tribe, including Tribal instrumentalities and entities that are wholly owned by Tribes; or
• It is a project where at least 50 percent of the project beneficiaries are members of Federally recognized Indian Tribes and non-Tribal applicants include a Tribal Resolution of Consent from the Tribe or Tribes that the applicant is proposing to serve.
• The application is from or benefits a Rural Partners Network's (RPN) community network. Currently RPN Networks exist in Alaska, Arizona, Georgia, Kentucky, Mississippi, Nevada, New Mexico, North Carolina, Puerto Rico, West Virginia and Wisconsin. Use the Community Look-Up map (available at
(3) Reducing climate pollution and increasing resilience to the impacts of climate change through economic support to rural communities. Using the Disadvantaged Community and Energy Community Look-Up Map (available at
• If the project is located in or serves a Disadvantaged Community as defined by the Climate and Economic Justice Screening Tool (CEJST), from the White House Council on Environmental Quality (CEQ);
• If the project is located in or serves an Energy Community as defined by the Inflation Reduction Act of 2022 (Pub. L. 117-169) (IRA); and
• If applicants can demonstrate through a written narrative how the proposed climate-impact projects will improve the livelihoods of community residents and meet pollution mitigation or clean energy goals.
2.
To distribute funds among the greatest number of projects possible during the respective funding periods, applications will be reviewed, organized and ranked in order from highest to lowest and funded up to the maximum funding available during each quarterly funding cycle in FY 2025.
1.
2.
(a)
(b)
(c) Additional requirements that apply to intermediaries selected for this program can be found in 7 CFR part 4274, subpart D.
(d) All successful applicants will be notified by letter which will include a Letter of Conditions and a Letter of Intent to Meet Conditions, which are not approval determinations. The loan will be considered approved when all conditions in the Letter of Conditions have been met and the Agency obligates the funding for the project.
3.
Intermediaries must collect and maintain data provided by Ultimate Recipients on race, sex, and national origin and ensure that Ultimate Recipients collect and maintain this data. Race and ethnicity data will be collected in accordance with the Office of Management and Budget (OMB)
The applicant and the Ultimate Recipients must comply with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, Executive Order 12250, Executive Order 13166 Limited English Proficiency (LEP), and 7 CFR part 1901, subpart E.
For General Questions About This Notice See the Point of Contact Provided in the
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(a) Faith-based organizations may apply for this award on the same basis as any other organization, as set forth at, and subject to the protections and requirements of, this part and any applicable constitutional and statutory requirements, including 42 U.S.C. 2000bb
(b) A faith-based organization that participates in this program will retain its independence from the Government and may continue to carry out its mission consistent with religious freedom and conscience protections in Federal law. Religious accommodations may also be sought under many of these religious freedom and conscience protection laws.
(c) A faith-based organization may not use direct Federal financial assistance from USDA to support or engage in any explicitly religious activities except when consistent with the Establishment Clause of the First Amendment to the United States Constitution and any other applicable requirements. An organization receiving Federal financial assistance also may not, in providing services funded by USDA, or in their outreach activities related to such services, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion, a
6.
Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information (
To file a program discrimination complaint, a complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form, which can be obtained online at
(1)
(2)
(3)
USDA is an equal opportunity provider, employer, and lender.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by CODEZOL, C.D., grantee of FTZ 163, requesting subzone status for the facility of Tallaboa PR, LLC, located in Peñuelas, Puerto Rico. 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 August 5, 2024.
The proposed subzone (13.79 acres) is located at State Road 127 Int. 385, Penuelas, Puerto Rico. No authorization for production activity has been requested at this time.
In accordance with the FTZ Board's regulations, Camille Evans 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 Camille Evans at
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 cast iron soil pipe from the People's Republic of China (China) would be likely to lead to continuation or recurrence of dumping at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable August 8, 2024.
Javier Barrientos, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2243.
On May 3, 2019, Commerce published the AD order on cast iron soil pipe from China.
On April 16, 2024, Commerce received a notice of intent to participate in this review from the Cast Iron Soil Pipe Institute (CISPI) within the deadline specified in 19 CFR 351.218(d)(1)(i).
On May 22, 2024, Commerce notified the U.S. International Trade Commission (ITC) that it did not receive an adequate substantive response from respondent interested parties.
On July 22, 2024, Commerce tolled the deadline in this administrative proceeding by seven days.
The product covered by the
A complete discussion of all issues raised in this sunset review is contained in the accompanying Issues and Decision Memorandum.
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 APO of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that oil country tubular goods (OCTG) from Ukraine were sold in the United States at less than normal value during the period of review (POR), July 1, 2022, through June 30, 2023. We invite interested parties to comment on these preliminary results.
Applicable August 8, 2024.
Toni Page, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1398.
On July 16, 2019, Commerce published the antidumping duty order on OCTG from Ukraine.
For a complete description of the events that followed the initiation of this review,
The merchandise subject to the
Commerce is conducting this review in accordance with section 751(a) of the Act. Constructed export price has been calculated in accordance with section 772 of the Act and normal value was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results,
Commerce preliminarily determines that the following estimated weighted-average dumping margin exists for the period July 1, 2022, through June 30, 2023:
Commerce intends to disclose the calculations used in our analysis to parties in this review within five days of the date of publication of this notice in the
Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.
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 respective case briefs. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice.
Upon completion of the administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Interpipe for which the producer did not know its merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Interpipe will be equal to the weighted-average dumping margin established in the final results of this administrative review, except if the rate is less than 0.50 percent and, therefore,
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of our analysis of issues raised by the parties in the written comments, within 120 days of publication of these preliminary results in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping 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.
These preliminary results of administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h)(2) and 351.221(b)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on cast iron soil pipe from the People's Republic of China (China) would be likely to lead to continuation or recurrence of countervailable subsidies at the levels indicated in the “Final Results of Review” section of this notice.
Applicable August 8, 2024.
Robert Galantucci, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2923.
On May 3, 2019, Commerce published in the
Commerce received an adequate substantive response to the notice of initiation from the CISPI within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days.
The product covered by the
All issues raised in this sunset review are addressed in the Issues and Decision Memorandum.
Pursuant to sections 751(c)(1) and 752(b) of the Act, Commerce determines that revocation of the
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a). 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 sanctionable violation.
We are issuing and publishing these final results in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that countervailable subsidies were provided to BGH Edelstahl Siegen GmbH (BGH), a producer and exporter of forged steel fluid end blocks (fluid end blocks) from Germany. The period of review (POR) is January 1, 2022, through December 31, 2022.
Applicable August 8, 2024.
Rachel Accorsi or Bob Palmer, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3149 or (202) 482-9068, respectively.
On February 7, 2024, Commerce published the
The products covered by the
All issues raised by interested parties in briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is provided in 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
Based on our review of the record and comments received from interested parties regarding our
Commerce conducted this review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found countervailable, we find that there is a subsidy,
As provided in section 782(i) of the Act, in May 2024, Commerce conducted verification of the subsidy information reported by BGH. We used standard verification procedures, including an examination of relevant sales and accounting records, and original source documents provided by the respondents.
As a result of this review, we determine the following net countervailable subsidy rate for the POR January 1, 2022, through December 31, 2022:
We intend to disclose the calculations performed in connection with the final results of review to parties in this proceeding within five days of the date of publication of this notice in the
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries of subject merchandise in accordance with the final results of this review, for BGH at the applicable
In accordance with section 751(a)(1) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for the POR for BGH Siegen listed above on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review. For all non-reviewed firms subject to the
This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice; correction.
The U.S. Department of Commerce (Commerce) published notice in the
Dakota Potts, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0223.
On July 22, 2024, Commerce published in the
In the
This notice is issued and published in accordance with sections 735(d) and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.210(c).
The final estimated dumping margins are as follows:
U.S. Artificial Intelligence Safety Institute (AISI), National Institute of Standards and Technology (NIST), U.S. Department of Commerce.
Notice; request for comments.
The U.S. Artificial Intelligence Safety Institute (AISI), housed within NIST at the Department of Commerce, requests comments on a draft document responsive to an Executive order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI) issued on October 30, 2023: NIST AI 800-1, Managing Misuse Risk for Dual-Use Foundation Models, found at
Comments containing information in response to this notice must be received on or before September 9, 2024, at 11:59 p.m. eastern time. Submissions received after that date may not be considered.
The draft of NIST AI 800-1, Managing Misuse Risk for Dual-Use Foundation Models is available for review and comment on the U.S. AI Safety Institute website at
• Comments on NIST AI 800-1 may be sent electronically to
Via
• To submit electronic public comments via the Federal eRulemaking Portal.
1. Go to
2. Click the “Comment Now!” icon, complete the required fields, including the relevant document number and title in the subject field, and
3. Enter or attach your comments.
• Written comments may also be submitted by mail to Information Technology Laboratory, ATTN: AI EO Document Comments, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8900, Gaithersburg, MD 20899-8900.
Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials. All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure.
AISI will not accept comments accompanied by a request that part or all of the material be treated confidentially because of its business proprietary nature or for any other reason. Therefore, do not submit confidential business information or otherwise sensitive, protected, or personal information, such as account numbers, Social Security numbers, or names of other individuals.
All relevant comments received by the deadline will be posted at
For questions about this request for comments contact:
AISI requests comments on the draft of Managing Misuse Risk for Dual-Use Foundation Models.
AISI welcomes input on all aspects of the draft guidance, such as modifications to the included objectives, practices, and recommendations; suggestions for additions or deletions; and areas where further empirical evidence is needed. The questions below are optional and intended to prompt feedback:
1. What practical challenges exist to meeting the objectives outlined in the guidance?
2. How can the guidance better address the ways in which misuse risks differ based on deployment (
3. How can the guidance better reflect the important role for real-world monitoring in making risk assessments?
4. How can the guidance's examples of documentation better support communication of practically useful information while adequately addressing confidentiality concerns, such as protecting proprietary information?
5. How can the guidance better enable collaboration among actors across the AI supply chain, such as addressing the role of both developers and their third-party partners in managing misuse risk?
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public outreach workshops.
Three free Atlantic Highly Migratory Species (HMS) Outreach Workshops will be held from August 19, 2024 through August 21, 2024 in locations across Puerto Rico. These workshops are being offered to be responsive to stakeholder requests for additional outreach in Puerto Rico and U.S. Caribbean communities. The objectives of the HMS Outreach Workshops are to educate fishers, dealers, and the general public on HMS regulations, distribute outreach materials, and assist fishers in applying for HMS permits.
The HMS Outreach Workshops will be held August 19, 2024 through August 21, 2024. See the
The HMS Outreach Workshops will be held in Cataño,
Delisse Ortiz,
Atlantic HMS fisheries are managed under the 2006 Consolidated HMS Fishery Management Plan and its amendments pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801
In recent years, HMS fisheries stakeholders, including fishers, dealers, and the general public, have requested that NMFS prioritize HMS fisheries management education and outreach in the U.S. Caribbean, specifically in Puerto Rico. To be responsive to stakeholder needs in Puerto Rico, NMFS is carrying out free HMS Outreach Workshops across three locations in Puerto Rico. The workshops are designed to educate fishers, dealers, and the general public on HMS regulations, distribute outreach materials, and assist fishers and dealers in applying for HMS permits. The increased engagement, outreach, and education in the U.S. Caribbean as a result of the HMS Outreach Workshops will help meet NMFS's goal of promoting sustainable fisheries and address key shark management outreach requests by our stakeholders in that region. These workshops are also consistent with NMFS's effort to encourage the involvement of disadvantaged or underserved communities consistent with Executive Orders 14008, 12898, and 13895.
1. August 19, 2024, 5 p.m.-7 p.m. AST, Villa Pesquera de Cataño, Centro Agropecuario, CVRF+QW4, Las Nereidas Ave., Cataño, PR 00962.
2. August 20, 2024, 4 p.m.-6 p.m. AST, Club Náutico de Guayama, Carr. 7710 Final Bo Pozuelo, Guayama, PR 00784.
3. August 21, 2024, 5 p.m.-7 p.m. AST, Centro de Usos Multiples de Fajardo, Salon B, Calle Dr. Lopez, Estacionamiento Municipal (5to piso), Fajardo, PR 00738.
Additional free HMS Outreach Workshops could be conducted in 2025 and will be announced in a future notice.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for a permit modification.
Notice is hereby given that the University of Maine, School of Marine Sciences, 5741 Libby Hall, Orono, ME 04469 (Gayle Zydlewski, Ph.D., Responsible Party), has requested a modification to scientific research Permit No. 20347-01.
Written comments must be received on or before September 9, 2024.
The modification request and related documents are available for review by selecting “Records Open for Public Comment” from the Features box on the Applications and Permits for Protected Species (APPS) home page,
Written comments on this application should be submitted via email to
Those individuals requesting a public hearing should submit a written request via email to
Malcolm Mohead or Erin Markin, Ph.D., (301) 427-8401.
The subject modification to Permit No. 20347-01, issued on March 12, 2019 (84 FR 15595, April 16, 2019), is requested under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Permit 20347-01 authorizes research on Atlantic sturgeon and shortnose sturgeon occurring in the Gulf of Maine (GOM) and its tributaries, including the Penobscot, Kennebec, Saco and Merrimack Rivers. Adult, sub-adult, and juvenile sturgeon of each species are sampled with nets, trawls, and trotlines, annually, and then measured, weighed, passive integrated transponder tagged, tissue sampled, and photographed. A subset are acoustically tagged, apical scute and fin ray sampled for age analysis, gastric lavaged, borescoped, and blood sampled. Early life stages of both sturgeon species are also collected to document the occurrence of spawning in GOM tributaries. The permit holder requests to increase the number of adult shortnose sturgeon (from 15 to 30) that may be captured in the Merrimack River for implant of telemetry tags to document sturgeon coastal movement as well as provide evidence of sturgeon access to the Lawrence Dam project boundary. The permit is valid through March 31, 2027.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (NEFMC) will host the Eighth National Meeting of the Scientific Coordination Subcommittee (SCS8) of the Council Coordination Committee. The meeting theme is “Applying Acceptable Biological Catch (ABC) Control Rules in a Changing Environment.” The objective of SCS8 is to provide actionable guidance on how to best support Councils in the management of fisheries, particularly on the use of ABC control rules, given the changing environment.
The meetings will be held from Monday, August 26 to Wednesday,
You can listen-only to the meeting online using a computer, tablet, or smart phone, or by phone only. Only the audio portion and presentations displayed on the screen at the SCS8 meeting will be broadcast.
Cate O'Keefe, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The SCS8 objective will be met through a series of keynote and case study presentations, as well as, small-group and plenary discussions on the following topics: Current approaches to defining ABC control rules and challenges in their application; Advances in ecosystem science and assessment to inform ABC control rules in a dynamic environment; Application of social science to achieve management goals under dynamic conditions Adaptation of reference points, control rules, and rebuilding plans to a changing environment. The agenda is subject to change, and the latest version will be posted at:
Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of receipt of application; 13 permit renewals, 2 permit modifications, and 6 new permits.
Notice is hereby given that NMFS has received 21 scientific research permit application requests relating to Pacific salmon, steelhead, green sturgeon, rockfish, and eulachon. The proposed research is intended to increase knowledge of species listed under the Endangered Species Act (ESA) and to help guide management and conservation efforts.
Comments or requests for a public hearing on the applications must be received at the appropriate address or fax number (see
All written comments on the applications should be sent by email to
The applications may be viewed online at:
Diana Dishman, Portland, OR (ph.: 503-736-4466), email:
The following listed species are covered in this notice:
Chinook salmon (
Steelhead (
Chum salmon (
Coho salmon (
Sockeye salmon (
Eulachon (
Rockfish: Endangered Puget Sound/Georgia Basin (PS/GB) Boccacio (
Green sturgeon (
Scientific research permits are issued in accordance with section 10(a)(1)(A) of the ESA (16 U.S.C. 1531
Anyone requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see
Under permit 1386-11M, the Washington Department of Ecology (WDOE) is seeking to modify a permit that would authorize them to continue taking adult and juvenile PS Chinook salmon, PS steelhead, HCS chum salmon, OL sockeye salmon, UCR spring-run Chinook salmon, UCR steelhead, MCR steelhead, SnkR spring/summer-run Chinook salmon, SnkR fall-run Chinook salmon, SnkR steelhead, LCR Chinook salmon, LCR coho salmon, LCR steelhead, and CR chum salmon. in order to characterize toxic contaminants in resident freshwater fish across Washington.
The WDOE conducts this research in order to meet Federal and State regulatory requirements. This research would benefit listed species by identifying toxic contaminants in resident and prey fish and thereby inform pollution control actions. The WDOE proposes to capture fish using various methods including backpack and boat electrofishing, beach seining, block, fyke, and gill netting, and angling. All captured salmon and steelhead would either be released immediately or held temporarily in an aerated live well to help them recover before release. The researchers do not propose to kill any fish but a small number may die as an unintended result of research activities.
Under permit 1484-8R, the Washington Department of Natural Resources (WA DNR), Pacific Cascade Region, is seeking to renew for 5 years a permit that would authorize them to continue taking juvenile MCR steelhead, LCR Chinook salmon, LCR coho salmon, LCR steelhead, and CR chum salmon in order to identify fish-bearing streams on WA DNR land in Southwest Washington. Most streams are typed as fish or non-fish bearing based on the physical characteristics of average width and gradient, and connectivity to established fish-bearing waters. This activity will occur on WA DNR land in Lewis, Pacific, Grays Harbor, Wahkiakum, Clark, Cowlitz, Skamania, and Klickitat counties in the state of Washington.
Juveniles would be collected via backpack electrofishing, and would be captured, handled (weighed, measured, and checked for marks or tags), and released. The captured fish would be identified and released back to the waters from which they came. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers are not proposing to kill any of the listed fish being taken, but a small number may be killed as an inadvertent result of these activities. The information gathered would be used to determine salmonid presence and distribution and thereby inform land management decisions on WA DNR holdings. This information would benefit listed species by helping WDNR identify existing man-made fish barriers, and ensuring fish-bearing streams receive adequate riparian buffers.
Under permit 1523-5R, the National Council for Air and Stream Improvements (NCASI) is seeking to renew for 5 years a permit that would authorize them to continue taking juvenile and adult UWR Chinook salmon in order to study water quality and biological conditions in rivers receiving paper and pulp mill discharges from their facilities. This work would take place in the upper Willamette and McKenzie Rivers in Oregon.
Adult and juvenile fish would be collected via backpack electrofishing or boat electrofishing. Juvenile and adult fish may be captured, handled (weighed, measured, and checked for marks or tags), and released. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The goal of the project is to identify changes in physical, chemical, and biological conditions in discharge watersheds, including biological assessments of periphyton, macroinvertebrate, and resident fish communities. Monitoring natural variability as well as changes resulting from pulp and paper mill discharges will allow researchers to identify where key sources of fish stress from impaired water quality are in the context of the larger watershed, and to rank the magnitude of those stressors. This study focuses on resident fish rather than migratory species such as ESA-listed salmon and steelhead, however, we expect that identifying areas with impaired water quality or habitat will benefit recovery planning for listed as well.
Under permit 15205-5R, Kwiáht the (Center for the Historical Ecology of the Salish Sea) is seeking to renew for 5 years a permit that would authorize them to continue taking juvenile PS Chinook salmon in order to understand long term changes in the food web that supports Salish Sea Chinook salmon populations. This work would take place on Lopez Island, Waldron Island, and Decatur Island in San Juan County, Washington.
Juveniles would be collected via beach seine. Juvenile fish identified as hatchery-origin would be captured, and may be handled (measured, weighed, and checked for marks or tags) prior to release. Captured natural-origin juveniles would be anesthetized, checked for marks and tags, lavaged for stomach contents, and tissue sampled prior to release. Scales shed during handling would also be retained. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this work is to characterize the food web supporting rearing juvenile Chinook salmon in the nearshore habitats of the San Juan Islands, and is expected to benefit ESA-listed PS Chinook salmon by identifying factors that may be limiting the growth and survival of outmigrating juveniles. A regime shift in regional weather patterns starting in 2014-2015 may have de-synchronized the relationship between outmigrating juvenile Chinook salmon and availability of prey, and this work aims to evaluate whether naturally-produced Chinook salmon can adapt to changes in key prey resources.
Under permit 15230-4R, the West Fork Environmental, Inc. is seeking to renew for 5 years a permit that would authorize them to continue taking juvenile PS Chinook salmon and PS steelhead in order to better understand the seasonal use of various reaches of the Tolt River by juvenile summer steelhead prior to their outmigration as smolts. These activities would take place in King County, Washington.
Juveniles would be collected via backpack electrofishing and hook and line angling. Juvenile Chinook salmon would be captured, handled (weighed, measured, checked for marks and tags), and released. Captured juvenile steelhead would be anesthetized, tissue sampled and PIT-tagged prior to release. A subset of steelhead will also have scale samples collected. The researchers are not proposing to kill any of the
The purpose of this study is to understand the reach-specific characteristics of juvenile summer steelhead rearing in the Tolt River across seasons, including information about timing of movement, size at age, and growth of juvenile steelhead in the upper reach. This work will also provide a better understanding of juvenile and adult summer steelhead movement across seasons, and the relative contribution of hatchery-origin fish to the summer steelhead population. This work is expected to benefit ESA-listed PS steelhead by informing managers about factors that may be limiting steelhead production within the Tolt River basin.
Under permit 16298-5R, the Shoshone-Bannock Tribes Fisheries Department is seeking to renew for 5 years a permit that would authorize them to continue taking adult SnkR spring/summer-run Chinook salmon and SnkR Basin steelhead in order to measure adult and juvenile Chinook salmon abundance and other salmon population viability parameters in Bear Valley Creek, Idaho.
Juveniles would be collected via screw trap, and the majority would be captured, handled (weighed, measured, and checked for marks and tags), and released. A subsample of captured juveniles would be anesthetized, tissue sampled, PIT-tagged, and may also have scale samples collected prior to release. Adults would be observed via a temporary fish counting station comprising a fish funneling weir, fish counting chamber, video surveillance system, and PIT tag antenna. Spawning ground surveys and creel surveys would also be conducted to enumerate spawning adults. No adult capture, handling, sampling, or tagging is proposed, but fish may be unintentionally injured or killed if impinged on or entangled in the weir. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this work is to continue maintaining a long-term dataset for Chinook salmon in Bear Valley Creek that includes information on abundance, productivity, spatial structure, run-timing, proportion of hatchery-origin contribution to the population, and genetic diversity. This work is expected to benefit ESA-listed SnkR Chinook salmon and steelhead by assisting fishery resource managers in identifying key factors that are preventing recovery in this basin.
Under permit 17062-7R, the NMFS Northwest Fisheries Science Center (NWFSC) is seeking to renew a permit that would authorize them to continue taking juvenile and adult PS Chinook salmon, PS steelhead, PS/Georgia Basin DPS bocaccio, PS/Georgia Basin DPS yelloweye rockfish, HCS chum salmon, and adult Southern DPS eulachon in order to collect demographic information and genetic samples from rockfish in Puget Sound. This work would take place across the main basins of Puget Sound, Hood Canal, and the San Juan Islands and other coastal areas in northern Puget Sound and the Strait of Juan de Fuca in the state of Washington.
Juveniles would be collected via minnow trap, moored mesh bags, hand or dip nets, and hook and line angling. Any Chinook salmon, steelhead, or chum collected would be handled (weighed, measured, checked for marks and tags) and released. Adult eulachon may also be unintentionally captured via these methods and would be released. Juvenile rockfish would be intentionally lethally sacrificed for genetic, tissue, and otolith analysis, and a small number may be from ESA-listed bocaccio or yelloweye rockfish DPSs. Adult salmon, steelhead, and rockfish would be collected via hook and line angling. Adult salmon and steelhead would be released without bringing them on board research vessels. Adult rockfish would be handled (weighed, measured, checked for marks and tags), tissue sampled, and floy-tagged prior to release at depth using a rapid descending device. The researchers are proposing to kill a small number of listed juvenile rockfish, and a small number of additional juvenile and adult fish may be killed as an inadvertent result of these activities.
The goal of this work is to collect biological, genetic, physiological and habitat information to evaluate bocaccio DPS structure and investigate how rocky reef, kelp forest, and eelgrass habitat characteristics affect the relative quality of these areas as nursery habitat for rockfishes in Puget Sound. This work is expected to benefit ESA-listed rockfish by providing more information on the structure of the endangered bocaccio DPS, and on juvenile rearing habitat quality and trophic relationships of rockfish relevant to managing yelloweye rockfish and bocaccio for recovery.
This study falls within the scope of the NWFSC research program that we previously analyzed in Biological Opinion WCRO-2023-01601. In that opinion, we concluded that the NWFSC research program would not jeopardize the continued existence of any ESA-listed species or destroy or adversely modify their critical habitats. In reaching our conclusion, we also considered activities related to permitting or authorizing individual studies under that research program for up to 10 years. Therefore, neither this study nor subsequently issuing a section 10(a)(1)(A) permit requires further consultation under the ESA.
Under permit 17761-3R, the East Bay Municipal Utility District is seeking to renew a permit that would authorize them to take adult and juvenile CCV steelhead in order to conduct monitoring and research of anadromous and resident fishes in the lower Mokelumne River. This work would take place in the San Joaquin Valley, in California.
Juveniles would be collected via backpack electrofishing, boat electrofishing, hook and line angling, beach seine, incline plane trap, screw trap, fish ladder, fyke trap, bypass trap, snorkel survey, and midwater trawl. All juvenile steelhead captured would be handled (weighed, measured, checked for marks and tags), and may be anesthetized as needed to collect accurate measurements, prior to release. A subsample of captured juveniles would be anesthetized, tissue sampled, and may be marked with photonic dye, elastomer tags, coded-wire tags, PIT-tags, acoustic tags, or floy tags prior to release. A subset of captured juvenile steelhead would also be gastric lavaged for stomach contents. A batch of hatchery-reared juvenile steelhead may also be implanted with acoustic tags prior to release.
Adults would be collected via fish weir, boat electrofishing, fish ladder, hook and line angling, incline plane trap, screw trap, fyke trap, and midwater trawl. Adults would be captured, handled (anesthetized, weighed, measured, and checked for marks or tags), and released. A subsample of captured adults would be anesthetized, tissue sampled and may be marked with photonic dye, elastomer tags, coded-wire tags, PIT-tags, acoustic tags, or floy tags prior to release. A subset of captured adult steelhead would also be gastric lavaged for stomach contents. Spawned adults or post-spawn carcasses would be enumerated via spawning surveys. Juvenile and adult fish would also be observed during snorkel surveys and video monitoring in the fish ladder. The
The goals of this project are to measure the success of the Lower Mokelumne River Restoration Program and determine if the modifications of the Lower Mokelumne River Project are appropriate for conserving fish and wildlife resources in the lower Mokelumne River. This project is expected to benefit ESA-listed species by providing scientific data to the Central Valley Project Improvement Act (CVPIA) Comprehensive Assessment and Monitoring Program (CAMP) to evaluate the relative effectiveness of CVPIA actions in restoring anadromous fish production.
Under permit 18852-3R, the U.S. Fish and Wildlife Service (USFWS) Mid-Columbia Fish and Wildlife Conservation Office is seeking to renew for 5 years a permit that would authorize them to continue taking juvenile and adult UCR spring-run Chinook salmon, UCR steelhead, and MCR steelhead in order to define the distribution and status of Pacific Lamprey, Bull Trout, and other native fish species. This work would take place in the Yakima, Wenatchee, Entiat, Methow, and Okanogan watersheds in the state of Washington.
Juveniles would be collected via backpack electrofishing, hand or dip net, fish ladders and weirs, minnow traps, and fyke nets. Most juvenile Chinook salmon and steelhead would not be targeted and, if captured, would be handled and immediately released. A subsample of captured juveniles may be anesthetized to identify species, obtain weights and measurements, and scanned for PIT tags before being released. Juvenile MCR steelhead trout captured in the Yakima Basin may be PIT-tagged and tissue sampled as well. Adults would be collected at dams and other structures and in traps, and may be caught by hook and line angling. Adult Chinook salmon or steelhead would be captured, handled (anesthetized, weighed, measured, and checked for marks or tags), and released, and may be anesthetized to identify species, obtain weights and measurements, and scanned for PIT tags before being allowed to recover and released. Spawned adults or post-spawn carcasses would be enumurated via spawning surveys. Juvenile and adult fish would also be observed during snorkel surveys. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this project is to assess recovery actions including capture and transport of Bull Trout to upstream of barriers, assessing fish utilization of restored habitat, and assessing Pacific Lamprey passage at existing structures and at lamprey-passage-engineered structures. This work is expected to benefit ESA-listed fish under the jurisdiction of the USFWS, and also provide information on passage barriers and habitat use relevant to managing listed Chinook salmon and steelhead in the UCR and MCR.
Under permit 18921-3R, the Samish Indian Nation is seeking to renew a permit that would authorize them to continue taking juvenile PS Chinook salmon and PS steelhead, and adult southern DPS eulachon in order to monitor the presence of fish species within and around the Cypress Island Secret Harbor restoration site. This work would take place on Cypress Island in Skagit County, Washington.
Juvenile PS Chinook salmon and steelhead and adult eulachon would be collected via beach seine. Captured fish would be handled (weighed, measured, and checked for marks or tags), and released. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this work is to assess the effectiveness of the Cypress Island Secret Harbor restoration project over 10 years after it was completed; particularly forage fish and salmonid habitat use within the site. Effective restoration at this site is expected to increase the amount of high quality estuarine habitat available to rearing PS Chinook salmon and steelhead juveniles, and this monitoring will provide managers information about whether the intended benefit has been realized.
Under permit 19263-3R, the Idaho Department of Fish and Game (IDFG) is seeking to renew for 5 years a permit that would authorize them to continue taking juvenile SnkR spring/summer-run Chinook salmon, SnkR Basin steelhead, and SnkR sockeye salmon in order to determine the distribution and abundance of various fish species in the Salmon River basin. This work would take place throughout the Salmon River basin in Idaho.
Juveniles would be collected via boat electrofishing. Juveniles of all three ESA-listed species may be anesthetized during capture and handling, however any SnkR sockeye juveniles will be released without tagging. A subsample of captured juvenile Chinook salmon and steelhead may be anesthetized, tissue sampled and PIT-tagged prior to release. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this project is to address various IDFG priority fisheries management and research issues relevant to their mandates, and to evaluate completed habitat restoration activities and prioritize future restoration actions. Both ESA-listed and resident fish are expected to benefit from research that will help inform decisions about how and where to protect and improve habitat conditions throughout the upper Salmon River basin.
Under permit 22944-2R, the NMFS NWFSC is seeking to renew a permit that would authorize them to continue taking juvenile UCR spring-run Chinook salmon, UCR steelhead, MCR steelhead, SnkR spring/summer-run Chinook salmon, SnkR fall-run Chinook salmon, SnkR Basin steelhead, SnkR sockeye salmon, LCR Chinook salmon, LCR coho salmon, LCR steelhead, CR chum salmon, Upper Willamette River Chinook salmon, and Upper Willamette River steelhead in order to document patterns of habitat occurrence, diet, and health indicators in juvenile salmon and steelhead in the Lower Columbia River. This work would take place in nearshore areas of the Lower Columbia River in Washington and Oregon, and in the Lower Willamette River in Oregon.
Juvenile salmon and steelhead would be collected via beach seine. Juvenile fish would be captured, handled (weighed, measured, and checked for marks and tags), and may be anesthetized to obtain measurements prior to release. A subsample of captured Chinook salmon juveniles would be anesthetized and further tissue sampled and PIT-tagged prior to release, and a small number would also be intentionally lethally sacrificed to determine their lipid content, conduct otolith analysis for health and growth assessment, do stomach content diet analyses, and take tissue samples for genetic stock identification. The
The objectives of the study are to better understand how juvenile salmonids utilize tidal freshwater habitats in the Columbia, to assess the quality of representative habitats in the lower river, to provide baseline data to guide habitat restoration and remediation activities, and to monitor the success of such activities at selected sites. The study is expected to benefit ESA-listed fish species by providing relevant information on (a) how habitat degradation may be affecting listed stocks that migrate through the Lower Columbia River and (b) what steps that can be taken to improve habitat quality.
This study falls within the scope of the NWFSC research program that we previously analyzed in Biological Opinion WCRO-2023-01601. In that opinion, we concluded that the NWFSC research program would not jeopardize the continued existence of any ESA-listed species or destroy or adversely modify their critical habitats. In reaching our conclusion, we also considered activities related to permitting or authorizing individual studies under that research program for up to 10 years. Therefore, neither this study nor subsequently issuing a section 10(a)(1)(A) permit requires further consultation under the ESA.
Under permit 23629-2R, the U.S. Geological Survey (USGS) is seeking to renew for 5 years a permit that would authorize them to continue taking adult UWR Chinook salmon and SONCC coho salmon in order to evaluate contaminant exposure, bioaccumulation, and effects in aquatic ecosystems and aquatic-dependent wildlife by assessing a wide range of contaminants (
Juvenile and adult salmon would be collected via backpack electrofishing, boat electrofishing, hook and line angling, gill net, beach seine, and minnow trap. This contaminant study targets resident fish species and does not target ESA-listed salmon and steelhead, therefore listed fish would be captured, handled (weighed, measured, and checked for marks or tags), and swiftly released. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this work is to evaluate contaminant risks in aquatic ecosystems of the Pacific Northwest and assess the factors that influence contaminant exposure and effects in aquatic wildlife. This work is expected to benefit ESA-listed salmon by providing greater understanding on where and why contaminant threats exist, what impacts they may have on ecological function, and how management efforts can be targeted to minimize potential risk and thereby help recovery planning for these species.
Under permit 23843-2R the Skagit River System Cooperative is seeking to renew a permit that would authorize them to take juvenile PS Chinook salmon and PS steelhead in order to measure changes in fish densities, smolt production, and habitat attributable to restoration activities to continue the assessment of restoration efforts within the Skagit River and its floodplain. This work will take place in multiple locations across the Skagit River Basin in the State of Washington.
Juveniles PS Chinook salmon and steelhead would be collected via weir, backpack electrofishing, boat electrofishing, or beach seining. Juvenile fish would be captured, handled (weighed, measured, and checked for marks or tags), and released. A subsample of captured juveniles would marked with a caudal fin clip or dye prior to release. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. Spawning adults or post-spawn carcasses would be enumurated via spawning surveys. Juvenile and adult fish would also be observed during snorkel surveys. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The goals of this project are to conduct traditional restoration effectiveness monitoring following restoration projects in the Skagit River Basin, and also contribute to development of a fish and habitat association model to inform restoration design. This work is expected to benefit ESA-listed fish by informing adaptive management of one restoration site specifically (Barnaby Slough) to increase the likelihood it will provide the expected habitat benefits for PS Chinook salmon and steelhead, and more broadly, improved fish and habitat association models that incorporate hydrodynamics will inform future restoration design.
Under permit 26776, Anchor QEA is seeking a new permit that would authorize them to take juvenile PS Chinook salmon and PS steelhead in order to conduct stream typing and evaluate culverts as potential barriers to fish passage in support of Pierce County. This work would be conducted in locations across Pierce County, Washington.
Juvenile PS Chinook salmon and steelhead would be collected via hand or dip netting and backpack electrofishing. Captured fish would be handled (weighed, measured, and checked for marks or tags) prior to release. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers will only deploy electrofishing if attempts to visually observe and identify fish from the bank and to sample fish by dip nets are unsuccessful. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this work is to confirm the upper extent of fish presence in potentially fish-bearing streams, and support the prioritization of fish passage structures to establish access to suitable habitat in the upstream extent of fish-bearing habitat. This work is expected to benefit ESA-listed species by informing the planning of restoration and enhancement efforts to improve salmonid habitat, and salmonid access upstream of anthropogenic barriers in Pierce County.
Under permit 27091-2M, the Port of Seattle is seeking to modify a permit that would authorize them to take additional juvenile PS Chinook salmon and PS steelhead in order to assess juvenile salmonid habitat use and the presence of key invertebrate prey resources in the Lower Duwamish Waterway T-117 restoration site. This work would be conducted solely within the Lower Duwamish River in King County, Washington.
Juveniles would be collected via fyke net. Juvenile salmon and steelhead would be anesthetized, tissue sampled and PIT-tagged prior to release. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this project is to characterize salmonid use of the restoration site during individual tidal cycles and monitor the physical and biological characteristics of the site to measure whether the restoration project is meeting its stated objectives. The restoration of the T-117 site is expected to benefit PS Chinook salmon and steelhead by increasing the area and functional value of riparian, estuarine marsh, exposed intertidal substrate, and shallow subtidal habitats used by salmonids, and this monitoring work will increase the likelihood the restoration will be managed to provide the expected habitat benefits.
Under permit 27824, the USGS is seeking a new permit that would authorize them to take juvenile SacR winter-run Chinook salmon in order to conduct egg incubation studies and mark-recapture monitoring programs to address juvenile production of winter-run Chinook salmon. This work will be conducted in Battle Creek and the Sacramento River below Shasta Dam, in the California Central Valley.
Juveniles would be collected via screw traps, and captured juveniles would be anesthetized, tissue sampled and PIT-tagged prior to release. Released juveniles may be recaptured using beach seines or backpack electrofishing, and handled (weighed, measured, checked for marks and tags) prior to release. Fertilized eggs from Livingston Stone National Fish Hatchery would be placed in egg boxes and set in designated redd locations along the Sacramento River. The egg boxes would be enclosed in mesh and visually observed from fertilization through emergence, and surviving alevins or fry will be released into the Sacramento River. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this project is to estimate tributary-level survival, somatic growth, and movement patterns of Chinook salmon, focusing on winter-run eggs and juveniles. These studies will help characterize influences of environmental conditions on salmon productivity, and are expected to benefit SacR winter-run Chinook salmon by addressing important data gaps for managers and informing habitat restoration efforts.
Under permit 28055 the Gold Ridge Resource Conservation District (GRCD) is seeking a new permit that would authorize them to take juvenile and adult CC Chinook salmon, CCC coho salmon, and CCC steelhead in order to document the status and trends of salmonid populations in watersheds of the Sonoma Coast. This work will be conducted in the Bodega Bay and Russian River basins in coastal California.
Juveniles would be collected via backpack electrofishing, hook and line angling, hand or dip net, beach seine, minnow trap, and funnel or pipe trap. Juvenile fish would be captured, handled (anesthetized, weighed, measured, and checked for marks or tags), and released. A subsample of captured juveniles would also be tissue sampled and PIT-tagged prior to release. Adults are not being targeted during this work, but some may be unintentionally collected via funnel or pipe trap or encountered during electrofishing. Captured adults would be handled (weighed, measured, and checked for marks or tags), and released. Spawned adults or post-spawn carcasses would be enumerated via spawning surveys, and tissues may be collected from carcasses encountered during spawning surveys. Adult and juvenile fish would be observed during snorkel surveys. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The goals of the restoration projects conducted by the GRCD are collectively to improve watershed health and resiliency for the benefit of salmonids, and these studies are intended to improve understanding of restoration needs by addressing information gaps about the current status of salmonid species in the targeted watersheds. This work is expected to benefit ESA-listed salmon and steelhead by providing information on the status and trends of their populations, and their contributions to broader ESUs, which can be used to better inform ESA-listed species management and restoration efforts.
Under permit 28158 the Northwest Straits Foundation is seeking a new permit that would authorize them to take juvenile PS Chinook salmon and PS steelhead and adult southern DPS eulachon in order to evaluate the impact of shoreline armoring removal, beach nourishment, vegetation enhancement and toxic cleanup restoration efforts on nearshore fish habitat use. This work would take place in Bowman Bay, Cornet Bay, and Fidalgo Bay in Skagit County and Island County in the state of Washington.
Juvenile salmon and steelhead and adult eulachon would be collected via beach seining. Fish would be captured, handled (identified, weighed, measured, and checked for marks or tags), and released. The researchers are not proposing to kill any of the listed fish being captured, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of the restoration projects managed by the Northwest Straits Foundation is to restore and enhance habitat for nearshore wildlife, including migrating salmon and their prey species. These restoration efforts are expected to benefit rearing PS Chinook and steelhead, and this pre- and post-construction monitoring work will increase the likelihood the restoration projects will be designed and managed to provide the expected habitat benefits.
Under permit 28199 the California State Polytechnic University Humboldt (Cal Poly Humboldt) is seeking a new permit that would authorize them to take adult SONCC coho salmon, NC steelhead, CC Chinook salmon, and SDPS green sturgeon in order to assess the presence, distribution, migration, habitat preferences, and movement patterns of sub-adult and adult green sturgeon. This work would take place in Humboldt Bay, Arcata Bay, Mad River Slough and Mad River Estuary in Humboldt and Del Norte Counties, in California.
Adults of all fish species would be collected via hook and line angling. This study is not targeting salmon or steelhead, so any CCC coho salmon, CC Chinook salmon, or NC steelhead captured would be immediately released. Captured adult green sturgeon would be handled (weighed, measured, and checked for marks or tags), tissue sampled and tagged with pop-up satellite archival tags prior to release. Adults would also be visually observed through vessel surveys and aerial surveys, including the use of cameras attached to aerial drones. The researchers are not proposing to kill any of the listed fish being captured, and do not anticipate any will be killed as an inadvertent result of these activities.
The purpose of this study is to assess the presence, distribution, and migration patterns of sub-adult and
Under permit 28292, the City of Portland is seeking a permit that would authorize them to take adult LCR Chinook salmon, LCR coho salmon, LCR steelhead, UWR Chinook salmon, and UWR steelhead while conducting a study to determine the levels of contamination in resident fish tissue and to continue documenting how tissue contamination levels are changing over the long term in the Columbia Slough. This work will be conducted within the lower Willamette River in Multnomah County, Oregon.
Juveniles and adults may be collected via boat electrofishing, and would be captured, handled, and released. ESA-listed fish are not being targeted for this study, but some may be unintentionally captured while targeting resident fish. In some cases, the researchers may not actually capture any fish but would merely note their presence, however electrofishing where listed species are observed would still be reported as take. The researchers are not proposing to kill any listed fish, but a small number of fish may be killed as an inadvertent result of these activities.
The purpose of this work is to assess whether or not upland source control actions are reducing toxic loads in fish tissue over time. This study is expected to benefit ESA-listed salmon and steelhead by providing data that will guide programmatic and risk management decisions in contaminated urban waterways and thereby reduce contaminant exposure and uptake in resident and migrating fish in the lower Willamette River over time.
This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the applications, associated documents, and comments submitted to determine whether the applications meet the requirements of section 10(a) of the ESA and Federal regulations. The final permit decisions will not be made until after the end of the 30-day comment period. NMFS will publish notice of its final action in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Pacific Fishery Management Council's (Pacific Council) Coastal Pelagic Species Management Team (CPSMT) and Coastal Pelagic Species Advisory Subpanel (CPSAS) will hold public meetings.
The CPSMT meeting will be held Wednesday, September 4, 2024, from 1 p.m. to 4 p.m., Pacific Time or until business for the day has been completed.
The CPSAS meeting will be held Friday, September 6, 2024, from 1 p.m. to 4 p.m., Pacific Time or until business for the day has been completed.
These meetings 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
Jessi Doerpinghaus, Staff Officer, Pacific Council; telephone: (503) 820-2415.
The primary purpose of the CPSMT and CPSAS online meetings are to discuss and develop work products and recommendations for the Pacific Council's September 2024 meeting. Topics will include marine planning, membership appointments, and workload planning for future meetings. Projects funded by the Inflation Reduction Act (IRA) will also be discussed. Other items on the Pacific Council's September agenda may be discussed. The CPSMT may also discuss the development of the Stock Assessment Fishery Evaluation document. The meeting agendas will be available on the Pacific Council's website in advance of the meetings. No management actions will be decided by the CPSMT or CPSAS. CPSMT and CPSAS recommendations will be considered by the Pacific Council at their September 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 (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of correction of a public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Joint Herring Committee and Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will
This webinar will be held on Thursday, August 22, 2024, at 9:30 a.m.
Webinar registration URL information:
Cate O'Keefe, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The original notice published in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 96 Recreational Landings Topical Working Group Webinar I for Southeast (SE) Yellowtail Snapper.
The SEDAR 96 assessment for SE yellowtail snapper will consist of a series of webinars. See
The SEDAR 96 Recreational Landings Topical Working Group Webinar I will be held August 29, 2024, from 10 a.m. to 12 p.m., Eastern.
Julie A. Neer, SEDAR Coordinator; (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and State and Federal agencies.
The items of discussion in the webinar are as follows:
Participants will discuss what recreational landings streams, including the SRFS (State of Florida's State Reef Fish Survey) data, that is available for use in the assessment of SE yellowtail snapper.
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.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
Defense Security Cooperation Agency, Department of Defense (DoD).
Arms sales notice.
The DoD is publishing the unclassified text of an arms sales notification.
Neil Hedlund at
This 36(b)(5)(C) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives with attached Transmittal 22-0P.
(i)
(ii)
Date: October 8, 2021
Military Department: Navy
(iii)
This transmittal notifies the addition of the following MDE items: one (1) MH-60R Multi-Mission helicopter; two (2) T-700-GE-401C engines (installed); two (2) Embedded Global Positioning System/Precise Positioning Service (GPS/PPS)/Inertial Navigation Systems (EGI) with Selective Availability/Anti-Spoofing Module (SAASM) (installed); and one (1) Link 16 Multifunctional Information Distribution Systems (MIDS)—Joint Tactical Radio System (JTRS) (installed). Also included is non-MDE APS-153(V) multi-mode radar; AN/AAS-44C(V) Multi-Spectral Targeting System; AN/AAR-47 Missile Warning System; AN/ALE-47 Chaff and Flare Dispenser, Electronic Countermeasures; AN/ALQ-210 Electronic Support Measures (ESM) System; and AN/ARQ-59 Hawklink radio terminal. The estimated total value of these items is $49.21 million, but will not cause an increase in the total estimated program cost. The total estimated case value will remain $985 million with MDE remaining $665 million of this total.
(iv)
(v)
(vi)
(vii)
Defense Security Cooperation Agency, Department of Defense (DoD).
Arms sales notice.
The DoD is publishing the unclassified text of an arms sales notification.
Neil Hedlund at
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives with attached Transmittal 22-57 and Policy Justification.
(i)
(ii)
Major Defense Equipment * $ 0 million
Other $162 million
TOTAL $162 million
(iii)
None
Included are MH-60R aircraft sustainment consumables and spare and repair parts; and other related elements of logistical and program support.
(iv)
(v)
(vi)
(vii)
(viii)
* As defined in Section 47(6) of the Arms Export Control Act.
The Government of Australia has requested to buy additional non-MDE MH-60R sustainment items and services that will be added to a previously implemented case. The original FMS case, valued at $89.8 million, included MH-60R sustainment. The estimated total cost is $162 million.
This proposed sale will support the foreign policy and national security objectives of the United States. Australia is one of our most important allies in the Western Pacific. The strategic location of this political and economic power contributes significantly to ensuring peace and economic stability in the region. It is vital to the U.S. national interest to assist our ally in developing and maintaining a strong and ready self-defense capability.
The proposed sale will continue Australia's capability to interoperate with U.S. forces by maintaining alignment with the U.S. Navy's MH-60R program and maintain mission readiness to deter regional threats and strengthen its homeland defense. Australia will have no difficulty absorbing this equipment and services into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor will be Lockheed Martin, Owego, NY. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Australia.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
Defense Security Cooperation Agency, Department of Defense (DoD).
Arms sales notice.
The DoD is publishing the unclassified text of an arms sales notification.
Neil Hedlund at
This 36(b)(5)(C) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives with attached Transmittal 22-0Q.
(i)
(ii)
Date: March 4, 2020
Military Department: Army
Funding Source: National Funds
(iii)
This transmittal notifies the inclusion of an additional four hundred ninety (490) Javelin missiles; and fifty (50) Javelin Light Weight Command Launch Units (LWCLU) (MDE). These non-MDE items are also included: Javelin LWCLU Basic Skills Trainers; Javelin Outdoor Trainers; Missile Simulation Rounds; System Integration and Check out; Javelin Restricted Interactive Electronic Technical Manual (IETM); Javelin Operator Manual, and Technical Assistance (TAGM); tools; Javelin Gunner Training; Ammunition Technical Officer Training (ATO); and
(iv)
(v)
(vi)
(vii)
Defense Security Cooperation Agency, Department of Defense (DoD).
Arms sales notice.
The DoD is publishing the unclassified text of an arms sales notification.
Neil Hedlund at
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives with attached Transmittal 22-61, Sensitivity of Technology, and Policy Justification.
(i)
(ii)
Major Defense Equipment * $512 million
Other $23 million
TOTAL $535 million
Funding Source: National Funds
(iii)
Also included is a Quality Assurance Team (QAT); transportation services; and other related elements of program and logistics support.
(iv)
(v)
(vi)
(vii)
(viii)
* As defined in Section 47(6) of the Arms Export Control Act.
The Government of Finland has requested to buy one hundred fifty (150) M30A1 Guided Multiple Launch Rocket System (GMLRS) Alternative Warhead (AW) (Steel Case), or M30A2 Guided Multiple Launch Rocket System (GMLRS) Alternative Warhead (AW) Missile Pods with Insensitive Munitions Propulsion System (IMPS), or a combination of both; and two hundred fifty (250) M31A1 GMLRS Unitary (GMLRS-U) Warhead (Steel Case), or M31A2 GMLRS-U IMPS, or a combination of both. Also included is a Quality Assurance Team (QAT); transportation services; and other related elements of program and logistics support. The total estimated cost is $535 million.
This proposed sale will support the foreign policy and national security of the United States by improving the security of a trusted partner, which is an important force for political stability and economic progress in Europe. It is vital to the U.S. national interest to assist Finland in developing and maintaining a strong and ready self-defense capability.
Finland intends to use these defense articles and services to increase its national stock, bolstering the land and air defense capabilities in Europe's northern flank. The increased national stock is critical to Finland's defense and deterrence due to the deteriorated security situation in Europe. Finland will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractors will be Lockheed Martin Corp, Missile and Fire Control, Grand Prairie, TX. There are no known offset agreements in connection with this potential sale. There is a request pending for diversion of 50% of this procurement from U.S. stock. That final decision will determine which version GMLRS could potentially be procured.
Implementation of this proposed sale will not require the assignment of U.S. Government or contractor representatives to Finland.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The M30A2 GMLRS-Alternative Warhead (AW) is a Department of Defense Cluster Munitions Policy compliant area suppression munition. The AW carries a 200-pound fragmentation assembly filled with high explosives which, upon detonation, accelerates two layers of preformed penetrators optimized for effectiveness against large area and imprecisely located targets. The M30A2 is a material change to the M30A1 GMLRS AW, incorporating the Insensitive Munition Propulsion System (IMPS) complaint motor. The IMPS motor minimizes the probability of inadvertent initiation and severity of collateral damage when subjected to damage, enhances survivability of launch systems and reduces risk of injury to personnel. The M30A2 shares a greater than 90% commonality with the M30A1. Commonalities include the Global Positioning System/Precise Positioning Service (GPS/PPS) aided inertial guidance and control systems, fuzing mechanisms, and multi-option height of burst fuze capability. They have an identical range of 70km + and a minimum range of 15km.
2. The M31A2 GMLRS Unitary Warhead is the Army's primary munition for the M142 HIMARS and M270A1/M270A2 Multiple Launcher Rocket System (MLRS) Launchers. The M31A2 Unitary is a material change to the M31A1 Unitary incorporating the Insensitive Munition Propulsion System (IMPS) complaint motor. The IMPS motor minimizes the probability of inadvertent initiation and severity of collateral damage when subjected to damage, enhances survivability of launch systems and reduces risk of injury to personnel. The M31A2 shares the same Global Positioning System/Precise Positioning Service (GPS/PPS) aided inertial guidance and control systems, fuzing mechanisms, and multi-mode fuzing capability. They have an identical range of 70km + and a minimum range of 15km.
3. The highest level of classification of defense articles, components, and services included in this potential sale is SECRET.
4. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
5. A determination has been made that Finland can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
6. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Finland.
Defense Security Cooperation Agency, Department of Defense (DoD).
Arms sales notice.
The DoD is publishing the unclassified text of an arms sales notification.
Neil Hedlund at
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives with attached Transmittal 22-59, Policy Justification, and Sensitivity of Technology.
(i)
(ii)
Other $250 million
TOTAL $450 million
(iii)
Up to thirty-two (32) Standard Missile 6 (SM-6) Block I Missiles (in two tranches of 16)
Also included are MK 21 Vertical Launch System (VLS) canisters; obsolescence engineering, integration and test activity; canister handling equipment, spares, training and training equipment/aids; technical publications/data; U.S. Government and contractor engineering, technical and logistical support services; and other related elements of logistical and program support.
(iv)
(v)
(vi)
(vii)
(viii)
* As defined in Section 47(6) of the Arms Export Control Act.
The Government of Japan has requested to buy up to thirty-two (32) Standard Missile 6 (SM-6) Block I missiles (in two tranches of 16). Also included are MK 21 Vertical Launch System (VLS) canisters; obsolescence engineering, integration and test activity; canister handling equipment, spares, training and training equipment/
This proposed sale will support the foreign policy goals and national security objectives of the United States by improving the security of a major ally that is a force for political stability and economic progress in the Asia-Pacific region.
The proposed sale will improve Japan's Air Defense and Ballistic Missile Defense capabilities against potential adversaries in the region. It will also provide the U.S.-Japan Security Alliance with the latest and most advanced capabilities, reducing Japan's reliance on U.S. Forces for the defense of Japan and further improving U.S.Japan military interoperability. Japan will have no difficulty absorbing these missiles into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor will be Raytheon Missiles and Defense (RMD), Tucson, AZ. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require U.S. Government and contractor personnel to visit Japan on a temporary basis in conjunction with program technical oversight and support requirements, including program and technical reviews, as well as to provide training and maintenance support in Japan.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The Standard Missile-6 (SM-6) is a surface Navy Anti-Air Warfare missile that provides area and ship self-defense. The missile is intended to project power and contribute to raid annihilation by destroying manned fixed and rotary wing aircraft, Unmanned Aerial Vehicles (UAV), Land Attack Cruise Missiles, and Anti-Ship Cruise Missiles in flight. It was designed to fulfill the need for a vertically launched, extended range missile compatible with the AEGIS Weapon System to be used against extended range threats at-sea, near land, and over land. The SM-6 combines the tested legacy of STANDARD Missile-2 (SM-2) propulsion and ordnance with an active Radio Frequency seeker allowing for over-the-horizon engagements, enhanced capability at extended ranges, and increased firepower.
2. The highest level of classification of defense articles, components, and services included in this potential sale is SECRET.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. A determination has been made that Japan can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
5. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Japan.
Corps of Engineers, Department of the Army, Department of Defense.
Notice of intent; withdrawal.
The U.S. Army Corps of Engineers (USACE) is issuing this notice to advise Federal, State, and local governmental agencies and the public that USACE is withdrawing the notice of intent for the preparation of the Draft Environmental Impact Statement (DEIS) for the Amite River and Tributaries-East of the Mississippi River, Louisiana, Flood Risk Management Feasibility Study, which was published in the
The notice of intent to prepare an EIS published in the
Department of the Army, U.S. Army Corps of Engineers, New Orleans District, 7400 Leake Avenue New Orleans, LA 70118-3651.
Questions about the withdrawal of the Notice of Intent can be directed to Jordan Logarbo, at (504) 862-1158 or
The study's purpose is to investigate flood risk reduction alternatives to reduce flood damages from rainfall in the Amite River Basin (ARB). The study is authorized by the Resolution of the Committee on Public Works of the United States Senate, adopted on April 14, 1967. The report is funded through Public Law 115-123 (the Bipartisan Budget Act of 2018).
A DIFR/EIS for this study was released on November 26, 2019, for concurrent public, technical, legal, and policy review. It evaluated four alternatives as a part of its final array, which included two dams, and a nonstructural plan in its final array. The TSP of the 2019 DIFR/EIS was an estimated $2.3 billion-dollar new large-scale dry dam with a nonstructural component to address residual risk over a 2200 mi
Due to these concerns the USACE re-evaluated critical tasks to inform the decision on the revised tentatively selected plan, a nonstructural-only plan for voluntary elevation of eligible residential structures and floodproofing of eligible nonresidential structures. The USACE does not anticipate that this revised TSP would have impacts requiring the preparation of an EIS. This was documented in the SSDIFR/EA. The
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before September 9, 2024.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Shedita Alston, 202-453-7090.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
The Department is requesting a revision of the survey for the following reasons: to add non-degree-granting institutions of higher education to the respondent universe; to change the timeframe for and revise one question; to revise the possible responses to one question; and to add three new questions regarding faculty/instructor disability training.
Institute of Education Sciences (IES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).
Interested persons are invited to submit comments on or before September 9, 2024.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Anousheh Shayestehpour, (202) 987-1148.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Grades 6-8 mark an extended and crucial period in which students are expected to master increasingly complex literacy skills (Biancarosa & Snow, 2006; Hagaman et al., 2016). By the middle school grades, reading instruction typically shifts from a focus on fundamental literacy skills, such as decoding and phonemic awareness, to genre-specific textual conventions, comprehension strategies, and learning curricular content from texts (Chall, 1983; Goldman & Snow, 2015). For students without the fundamental skills to read fluently, decode accurately, and comprehend text, the more advanced literacy practices needed for secondary content acquisition and text reading can be out of reach. Students who struggle with reading at the middle school level often have limited ability to access curricular content aligned to grade-level standards in English language arts and other subject areas (Torgesen et al., 2007) and may experience adverse educational outcomes with respect to attendance (Fisher & Frey, 2014), graduation rates (Daniel et al., 2006), and mental health (Daniel et al., 2006; Mugnaini et al., 2009).
The purpose of this evaluation is to test the efficacy of the Providing Reading Interventions for Students in Middle School Toolkit, or the PRISMS Toolkit. This toolkit supports the application of evidence-based recommendations from the What Works Clearinghouse (WWC) Providing Reading Interventions for Students in Grades 4-9 Educator's Practice Guide (hereafter, practice guide; Vaughn et al., 2022) through a suite of professional development activities. We anticipate that the toolkit will impact teacher knowledge, self-efficacy, and instructional practice. These changes in teacher knowledge, beliefs, and practice, in turn, will positively impact student outcomes, including student engagement, as measured by student engagement in reading and school attendance, and reading proficiency.
The evaluation team plans to conduct an independent evaluation using a school-level, cluster randomized control trial design to assess the program's impact on teachers' practices and beliefs and students' engagement and literacy outcomes. The evaluation will also assess the implementation of the toolkit and how it may be effectively scaled. The evaluation will take place in 52 schools across an estimated 10 districts in Texas and will focus on teachers and students in grade 6-8. The evaluation will produce a report and presentations to study participants, practitioners, policymakers, and researchers, and infographics and blog posts for a wider audience of educators and policymakers. These will be designed to inform district and school leaders and teachers about reading interventions that could be beneficial for all students in grade 6-8, but particularly those who are reading below grade level expectations.
Take notice that on July 18, 2024, Rover Pipeline LLC (Rover), 8111 Westchester Drive, Suite 600, Dallas, Texas 75225, filed an application under section 7(c) of the Natural Gas Act (NGA), and part 157 of the Commission's regulations requesting authorization for its Rover-Berne Meter Station Expansion Project (Project). The Project will consist of the replacement of the existing filter separator with a new, larger filter separator, within the existing Rover-Berne Meter Station located at Milepost 0.0 on Rover's Berne Lateral in Monroe County, Ohio. The new, larger filter separator will allow Rover to increase the meter station receipt capacity from 350,000 dekatherms per day (Dth/d) to 400,000 Dth/d. Rover estimates the total cost of the Project to be $950,000, all as more fully set forth in the application which is on file with the Commission and open for public inspection.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
Any questions regarding the proposed project should be directed to Blair Lichtenwalter, Senior Director of Regulatory Affairs, Rover Pipeline LLC, 1300 Main Street, Houston, Texas 77002, by phone at (713) 989-2605 or by email at
Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: you can file comments on the project, you can protest the filing, and you can file a motion to intervene in the proceeding. There is no fee or cost for filing comments or intervening. The deadline for filing a motion to intervene is 5:00 p.m. Eastern Time on August 22, 2024. How to file protests, motions to intervene, and comments is explained below.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Any person wishing to comment on the project may do so. Comments may include statements of support or objections, to the project as a whole or specific aspects of the project. The more specific your comments, the more useful they will be.
Pursuant to sections 157.10(a)(4)
To ensure that your comments or protests are timely and properly recorded, please submit your comments on or before August 22, 2024.
There are three methods you can use to submit your comments or protests to the Commission. In all instances, please reference the Project docket number CP24-496-000 in your submission.
(1) You may file your comments electronically by using the eComment feature, which is located on the Commission's website at
(2) You may file your comments or protests electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments or protests by mailing them to the following address below. Your written comments must reference the Project docket number (CP24-496-000).
The Commission encourages electronic filing of comments (options 1 and 2 above) and has eFiling staff available to assist you at (202) 502-8258 or
Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list, and will receive notification when the environmental documents (EA or EIS) are issued for this project and will be notified of meetings associated with the Commission's environmental review process.
The Commission considers all comments received about the project in determining the appropriate action to be taken. However, the filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding. For instructions on how to intervene, see below.
Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
There are two ways to submit your motion to intervene. In both instances,
(1) You may file your motion to intervene by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your motion to intervene, along with three copies, by mailing the documents to the address below. Your motion to intervene must reference the Project docket number CP24-496-000.
The Commission encourages electronic filing of motions to intervene (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail at: Blair Lichtenwalter, Senior Director of Regulatory Affairs, Rover Pipeline LLC, 1300 Main Street, Houston, Texas 77002 or by email at
All timely, unopposed
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
On July 2, 2024, the City of Miami, Oklahoma (City), filed a request for clarification of Commission staff's June 3, 2024 order
On July 17, 2024, GRDA filed an answer to the City's request for clarification asserting that the Commission should reject the City's request because no clarification is needed, it is time barred under section 313(a) of the FPA, and it is relitigating issues that the Commission has previously rejected.
The City's request for clarification concerns the scope of the flooding and property rights report required by the Commission's Order on Remand and discussed in GRDA's request for an extension of time to file its report. Rule 213 of the Commission's regulations allows for an answer to a motion for an extension of time within five days after the motion is filed.
Take notice that on July 24, 2024, Columbia Gas Transmission, LLC (Columbia), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, filed in the above referenced docket, a prior notice request pursuant to sections 157.205, 157.213 and 157.216 of the Commission's regulations under the Natural Gas Act (NGA), and Columbia's blanket certificate issued in Docket No. CP83-76-000, for authorization to convert one existing injection/withdrawal well to observation status and to abandon or replace associated storage lines and appurtenant facilities located at the Laurel Storage Field in
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at
Any questions concerning this request should be directed to David A. Alonzo, Manager, Project Authorizations, 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, by phone at (832)-320-5477, or by email at david
There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on September 30, 2024. How to file protests, motions to intervene, and comments is explained below.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Pursuant to section 157.205 of the Commission's regulations under the NGA,
Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before September 30, 2024. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP24-503-000 in your submission.
(1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP24-503-000.
The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: David A. Alonzo, Manager, Project Authorizations, 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, or by email at
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
This is a supplemental notice in the above-referenced proceeding of 69SV 8me LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 21, 2024.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
This is a supplemental notice in the above-referenced proceeding of Blue Bird Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 21, 2024.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Federal Energy Regulatory Commission (FERC), DOE.
Notice of a modified system of records.
In accordance with the Privacy Act of 1974, all agencies are required to publish in the
Comments on this modified system of records must be received no later than 30 days after date of publication in the
Comments may be submitted in writing to Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, or electronically to
Mittal Desai, Chief Information Officer & Senior Agency Official for Privacy, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, (202) 502-6432.
In accordance with the Privacy Act of 1974, and to comply with the Office of Management and Budget (OMB) Memorandum M-17-12,
The following sections have been updated to reflect changes made since the publication of the last notice in the
Department of Energy (DOE) Inspector General Investigative Records Relating to the Federal Energy Regulatory Commission (FERC-48).
Unclassified.
Federal Energy Regulatory Commission, Chief Security Officer Directorate, Office of the Executive Director, 888 First Street NE, Washington, DC 20426.
Security Specialist, Chief Security Officer Directorate, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
Public Law 95-452, as amended; 5 U.S.C. 401-424.
The system is used to collect and maintain records concerning FERC investigations and documentation on investigations conducted by the DOE Inspector General. FERC uses the system to manage referrals to and from DOE Inspector General; and to provide authorized assistance to lawful administrative, civil, counterintelligence, and criminal investigations.
The following categories of individuals are covered by this system: present and former FERC employees, contractors, assignees, interns, visitors, and guests. In addition, persons who report concerns, witnesses, relatives, or parties who have been identified by DOE Inspector General for further investigation, and individuals with other relevant personal associations with FERC insider are covered by the system of records notice.
Records include: full name, title, office, type of violation, laptop assignment number, IP address, case name, time and attendance records, building access logs, contact information, correspondence relevant to the investigation; internal staff correspondence, subpoenas issued during the investigation, affidavits, statements from witnesses, transcripts of testimony taken in the course of the investigation and accompanying exhibits; documents and records or copies obtained during the investigation; working papers of the staff and other documents and records relating to the investigation; opening reports, progress reports and closing reports; and any other information gathered in the course of or relating to an inquiry, review, inspection, or investigation of a criminal, civil, or administrative nature.
Records are obtained from (1) software that monitors FERC's user's activity on U.S. Government computer networks; (2) information supplied by individuals to FERC or by the individual's employer; (3) information provided to FERC to gain access to FERC facilities, information, equipment, networks, or systems; (4) publicly available information obtained from open source platforms, including publicly available social media; (5) any departmental records for which the individual has been granted authorized access to; (6) any federal, state, tribal, local government, or private sector records for which the individual has been given authorized access to; (7) individuals who are the subject of the investigation or inquiry, employer, law enforcement organizations, and detention facilities; (8) individuals including, where practicable, those to whom the information relates; (9) witnesses, corporations and other entities; (10) records of individuals and of the Commission; (11) records of other entities; (12) Federal, foreign, state or local bodies and law enforcement agencies; (13) documents, correspondence relating to litigation, and transcripts of testimony; and (14) miscellaneous other sources. FERC also receives tips and leads by other means, such as email or telephone.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, information maintained in this system may be disclosed to authorized entities outside FERC for purposes determined to be relevant and necessary as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. To appropriate agencies, entities, and persons when (1) FERC suspects or has confirmed that there has been a breach of the system of records; (2) FERC has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Commission (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
2. To another Federal agency or Federal entity, when FERC determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
3. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of that individual.
4. To the Equal Employment Opportunity Commission (EEOC) when requested in connection with investigations of alleged or possible discriminatory practices, examination of Federal affirmative employment programs, or other functions of the Commission as authorized by law or regulation.
5. To the Federal Labor Relations Authority or its General Counsel when
6. To disclose information to another Federal agency, to a court, or a party in litigation before a court or in an administrative proceeding being conducted by a Federal agency, when the Government is a party to the judicial or administrative proceeding. In those cases where the Government is not a party to the proceeding, records may be disclosed if a subpoena has been signed by a judge.
7. To the Department of Justice (DOJ) for its use in providing legal advice to FERC or in representing FERC in a proceeding before a court, adjudicative body, or other administrative body, where the use of such information by the DOJ is deemed by FERC to be relevant and necessary to the advice or proceeding, and such proceeding names as a party in interest: (a) FERC; (b) any employee of FERC in his or her official capacity; (c) any employee of FERC in his or her individual capacity where DOJ has agreed to represent the employee; or (d) the United States, where FERC determines that litigation is likely to affect FERC or any of its components.
8. To non-Federal Personnel, such as contractors, agents, or other authorized individuals performing work on a contract, service, cooperative agreement, job, or other activity on behalf of FERC or Federal Government and who have a need to access the information in the performance of their duties or activities.
9. To the National Archives and Records Administration in records management inspections and its role as Archivist.
10. To the Merit Systems Protection Board or the Board's Office of the Special Counsel, when relevant information is requested in connection with appeals, special studies of the civil service and other merit systems, review of OPM rules and regulations, and investigations of alleged or possible prohibited personnel practices.
11. To appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information may be relevant to a potential violation of civil or criminal law, rule, regulation, order.
12. To appropriate agencies, entities, and person(s) that are a party to a dispute, when FERC determines that information from this system of records is reasonably necessary for the recipient to assist with the resolution of the dispute; the name, address, telephone number, email address, and affiliation; of the agency, entity, and/or person(s) seeking and/or participating in dispute resolution services, where appropriate.
13. Where there is an indication of a violation or a potential violation of law, whether civil, criminal or regulatory in nature, whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred to the appropriate agency, whether federal, foreign, state, or local, charged with enforcing or implementing the statute, or rule, regulation or order.
14. To Federal, foreign, state, or local authorities in order to obtain information or records relevant to an Inspector General investigation.
15. To Federal, foreign, state, or local governmental authorities maintaining civil, criminal, or other relevant enforcement information or other pertinent information to obtain information relevant to an agency decision concerning the hiring or retention of an employee, the issuance of a security clearance, the letting of a contract, or the issuance of a license, grant or other benefit.
16. To Federal, foreign, state, or local governmental authorities in response to their request in connection with the hiring or retention of an employee, discriminatory or other administrative action concerning an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of a license, grant or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision in the matter.
17. To non-governmental parties where those parties may have information the Inspector General seeks to obtain in connection with an investigation.
18. To independent auditors or other private firms with which the Inspector General has contracted to carry out an independent audit, or to collate, aggregate or otherwise refine data collected in the system of records.
19. To respond to subpoenas in any litigation or other proceeding.
Records are stored in electronic and paper format. Electronic records are stored on a restricted shared drive, and some records are in the individual's human resources file. Paper records are stored in lockable file room. Access to electronic records is controlled by the organizations Single Sign-On and Multi-Factor Authentication solution. Agency buildings and Data center buildings are guarded and monitored by security personnel, cameras, ID checks, and other physical security measures. Access to electronic and hard copy files is restricted to those individuals whose official duties require access.
Records are retrieved by name and log number.
Records are retained and disposed of in accordance with the schedule approved under the Department of Energy Administration Records Schedule 22: Audit/Investigative Records (October 2021, Rev. 4) available at
Individuals requesting access to the contents of records must submit a request through the Freedom of Information Act (FOIA) office. The FOIA website is located at:
Generalized notice is provided by the publication of this notice. For specific notice, see Records Access Procedure, above system.
None.
65 FR 21759 (April 24, 2000).
Federal Energy Regulatory Commission, DOE.
Notice of information collection and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-585 (Reporting of Electric Energy Shortages and Contingency Plans Under PURPA Section 206).
Comments on the collection of information are due October 7, 2024.
You may submit copies of your comments (identified by Docket No. IC24-26-000) by one of the following methods:
Electronic filing through
•
• For those unable to file electronically, comments may be filed by USPS mail or by other delivery methods:
○
○
Jean Sonneman may be reached by email at
• any anticipated shortages of electric energy or capacity which would affect the utility's capability to serve its wholesale customers; and
• a contingency plan that would outline what circumstances might give rise to such occurrences.
• In Order No. 575,
○ it will treat firm power wholesale customers without undue discrimination or preference; and
○ it will report any modifications to its contingency plan for accommodating shortages within 15 days to the appropriate state regulatory agency and to the affected wholesale customers, then the utility need not file with the Commission an additional statement of contingency plan for accommodating such shortages.
This revision changed the reporting mechanism, specifically the public utility's contingency plan would be in its filed rate rather than in a separate document. In Order No. 659,
• examine and approve or modify utility actions;
• prepare a response to anticipated disruptions in electric energy; and/or
• ensure equitable treatment of all public utility customers under the shortage situation.
The Commission implements these filing requirements in the Code of Federal Regulations (CFR) under 18 CFR part 294.101.
On May 24, 2018, Grand River Dam Authority, licensee for the Pensacola Hydroelectric Project No. 1494, filed an application for a non-capacity amendment for the Coal Creek Wildlife Management Area in compliance with the requirements of Article 411 of the Pensacola Project license
No motion in opposition to the notice of withdrawal has been filed, and the Commission has taken no action to disallow it. Accordingly, pursuant to Rule 216(b) of the Commission's Rules of Practice and Procedure,
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental document that will discuss the environmental impacts of the Sabine Pass Stage 5 Expansion Project involving construction and operation of facilities by Sabine Pass Liquefaction, LLC and Sabine Pass Liquefaction Stage V, LLC (collectively, Sabine Pass), and Sabine Crossing, LLC (Sabine Crossing) in Cameron Parish, Louisiana, and Liberty, Jefferson, and Chambers Counties, Texas. The Commission will use this environmental document in its decision-making process to determine whether the planned pipeline project is in the public convenience and necessity and if the planned liquid natural gas facility expansion is in the public interest.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies regarding the project. As part of the National Environmental Policy Act (NEPA) review process, the Commission takes into account concerns the public may have about proposals and the environmental impacts that could result from its action whenever it considers the issuance of a Certificate of Public Convenience and Necessity and authorization. This gathering of public input is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the environmental document on the important environmental issues. Additional information about the Commission's NEPA process is described below in the NEPA Process and Environmental Document section of this notice.
By this notice, the Commission requests public comments on the scope of issues to address in the environmental document. To ensure that your comments are timely and properly recorded, please submit your comments so that the Commission receives them in Washington, DC on or before 5:00 p.m. Eastern Time on September 3, 2024. Comments may be submitted in written or oral form. Further details on how to submit comments are provided in the Public Participation section of this notice.
Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the environmental document. Commission staff will consider all written or oral comments during the preparation of the environmental document.
If you submitted comments on this project to the Commission before the opening of this docket on February 22,
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this planned project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the planned facilities. The company would seek to negotiate a mutually acceptable easement agreement. You are not required to enter into an agreement. However, if the Commission approves the project, the Natural Gas Act conveys the right of eminent domain to the company. Therefore, if you and the company do not reach an easement agreement, the pipeline company could initiate condemnation proceedings in court. In such instances, compensation would be determined by a judge in accordance with State law. The Commission does not subsequently grant, exercise, or oversee the exercise of that eminent domain authority. The courts have exclusive authority to handle eminent domain cases; the Commission has no jurisdiction over these matters.
A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” addresses typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. This fact sheet along with other landowner topics of interest are available for viewing on the FERC website (
There are four methods you can use to submit your comments to the Commission. Please carefully follow these instructions so that your comments are properly recorded. The Commission encourages electronic filing of comments and has staff available to assist you at (866) 208-3676 or
(1) You can file your comments electronically using the eComment feature, which is located on the Commission's website (
(2) You can file your comments electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments by mailing them to the Commission. Be sure to reference the project docket number (PF23-2-000) on your letter. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Acting Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Acting Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
(4) In lieu of sending written comments, the Commission invites you to attend the public scoping session its staff will conduct in the project area, scheduled as follows:
The primary goal of this scoping session is to have you identify the specific environmental issues and concerns that should be considered in the environmental document. Individual oral comments will be taken on a one-on-one basis with a court reporter. This format is designed to receive the maximum amount of oral comments in a convenient way during the timeframe allotted.
The scoping session is scheduled from 5:00 p.m. to 7:00 p.m. Central Daylight Time. You may arrive at any time after 5:00 p.m. There will not be a formal presentation by Commission staff when the session opens. If you wish to speak, the Commission staff will hand out numbers in the order of your arrival. Comments will be taken until 7:00 p.m. However, if no additional numbers have been handed out and all individuals who wish to provide comments have had an opportunity to do so, staff may conclude the session at 6:30 p.m. Please see appendix 1 for additional information on the session format and conduct.
Your scoping comments will be recorded by a court reporter (with FERC staff or representative present) and become part of the public record for this proceeding. Transcripts will be publicly available on FERC's eLibrary system (see the last page of this notice for instructions on using eLibrary). If a significant number of people are interested in providing oral comments in the one-on-one settings, a time limit may be implemented for each commentor.
It is important to note that the Commission provides equal consideration to all comments received, whether filed in written form or provided orally at a scoping session. Although there will not be a formal presentation, Commission staff will be available throughout the scoping session to answer your questions about the environmental review process. Representatives from Sabine Crossing will also be present to answer project-specific questions.
Additionally, the Commission offers a free service called eSubscription, which makes it easy to stay informed of all issuances and submittals regarding the dockets/projects to which you subscribe. These instant email notifications are the fastest way to receive notification and provide a link to the document files which can reduce the amount of time you spend researching proceedings. Go to
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and
Sabine Pass and Sabine Crossing plan to expand existing liquefied natural gas (LNG) facilities and construct a new natural gas pipeline to provide a feed supply to the LNG terminal. The Sabine Pass Stage 5 Expansion Project (Project) would be located in Cameron Parish, Louisiana and Liberty, Chambers, and Jefferson Counties, Texas and would consist of constructing the following facilities:
• two natural gas liquefaction trains;
• two aboveground LNG storage tanks;
• boil off gas re-liquefaction unit;
• operations and maintenance building;
• a new 57.6-mile, 48-inch-diameter natural gas pipeline;
• one new compressor station;
• two pig traps; and
• four mainline valves and one tap valve.
Sabine Pass also proposes modifications to existing ship-loading facilities.
The general location of the project facilities is shown in appendix 2.
Construction of the planned facilities would disturb about 1,013.4 acres of land for the LNG facilities and the pipeline. Following construction, Sabine Pass and Sabine Crossing would maintain about 884.1 acres for permanent operation of the Project's facilities; the remaining acreage would be restored and could revert to former uses. About 60 percent of the planned pipeline route parallels existing pipeline, utility, or road rights-of-way.
Any environmental document issued by Commission staff will discuss impacts that could occur as a result of the construction and operation of the planned project under the relevant general resource areas:
• geology and soils;
• water resources and wetlands;
• vegetation and wildlife;
• threatened and endangered species;
• cultural resources;
• land use;
• socioeconomics;
• environmental justice;
• air quality and noise;
• reliability and safety; and
• climate change.
Commission staff have already identified several issues that deserve attention based on a preliminary review of the planned facilities and the environmental information provided by Sabine Pass and Sabine Crossing. This preliminary list of issues may change based on your comments and our analysis:
• permanent wetland impacts;
• flooding and storm surge;
• cumulative impacts; and
• alternative routes.
Commission staff will also evaluate reasonable alternatives to the planned project or portions of the project and make recommendations on how to lessen or avoid impacts on the various resource areas. Your comments will help Commission staff identify and focus on the issues that might have an effect on the human environment and potentially eliminate others from further study and discussion in the environmental document.
Although no formal application has been filed, Commission staff have already initiated a NEPA review under the Commission's pre-filing process. The purpose of the pre-filing process is to encourage early involvement of interested stakeholders and to identify and resolve issues before the Commission receives an application. As part of the pre-filing review, Commission staff will contact Federal and State agencies to discuss their involvement in the scoping process and the preparation of the environmental document.
If a formal application is filed, Commission staff will then determine whether to prepare an Environmental Assessment (EA) or an Environmental Impact Statement (EIS). The EA or the EIS will present Commission staff's independent analysis of the environmental issues. If Commission staff prepares an EA, a
With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues related to this project to formally cooperate in the preparation of the environmental document.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, the Commission is using this notice to initiate consultation with the applicable State Historic Preservation Office(s), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes Federal, State, and local government representatives and agencies; elected officials;
If you need to make changes to your name/address, or if you would like to remove your name from the mailing list, please complete one of the following steps:
(1) Send an email to
(2) Return the attached “Mailing List Update Form” (appendix 3).
Once Sabine Crossing files its application with the Commission, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Only intervenors have the right to seek rehearing of the Commission's decision and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214). Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website (
Public sessions or site visits will be posted on the Commission's calendar located at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. This application is not ready for environmental analysis at this time.
n.
The proposed project does not include a dam or impoundment. The applicant proposes to manually operate the project in a run-of-river mode.
o. Copies of the application may be viewed on the Commission's website at
You may also register online at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
p. With this notice, we are initiating consultation with the Connecticut State Historic Preservation Officer (SHPO), as required by section 106 of the National Historic Preservation Act and the regulations of the Advisory Council on Historic Preservation, 36 CFR 800.4.
q. Procedural schedule: The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate (
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA or Agency) is announcing the availability of the final, updated Safer Choice and Design for the Environment (DfE) Standard (“the Standard”). This update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment. DfE is a similar program used by EPA for the purpose of helping consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as well as other EPA DfE criteria (as described in the Standard).
The Standard is effective August 8, 2024.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0520, is available online at
Melanie Adams, Safer Choice Program (7406M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1201 Constitution Ave. NW, Washington DC 20004; telephone number: (202) 564-1843; email address:
You may be affected by this action if you participate in or apply for certification under the Safer Choice or DfE programs and use or hope to use the programs' label or logo, respectively, on your products. Also potentially affected are consumers, institutional purchasers, retailers, and distributors of Safer Choice- or DfE-certified products who use the label or logo to identify products that have met the Agency's safer-product criteria. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Affected entities may include:
• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180);
• All Other Basic Organic Chemical Manufacturing (Primary) (NAICS code 325199);
• Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 325320);
• Paint and Coating Manufacturing (NAICS code 325510);
• Adhesive Manufacturing (NAICS code 325520);
• Soap and Other Detergent Manufacturing (NAICS code 325611);
• Polish and Other Sanitation Good Manufacturing (NAICS code 325612);
• Surface Active Agent Manufacturing (Primary) (NAICS code 325613);
• Toilet Preparation Manufacturing (NAICS code 325620);
• Photographic Film, Paper, Plate, and Chemical Manufacturing (NAICS code 325992);
• All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998);
• Service Establishment Equipment and Supplies Merchant Wholesalers (Primary) (NAICS code 423850);
• Other Chemical and Allied Products Merchant Wholesalers (Primary) (NAICS code 424690);
• Supermarkets and Other Grocery (except Convenience) Stores (Primary) (NAICS code 445110);
• All Other Specialty Food Stores (NAICS code 445299);
• Pharmacies and Drug Stores (NAICS code 446110);
• Office Supplies and Stationery Stores (NAICS code 453210);
• All Other Miscellaneous Store Retailers (except Tobacco Stores) (Primary) (NAICS code 453998);
• Electronic Shopping and Mail-Order Houses (NAICS code 454110);
• Research and Development in Biotechnology (except Nanobiotechnology) (Primary) (NAICS code 541714);
• Facilities Support Services (NAICS code 561210). Janitorial Services (NAICS code 561720);
• Carpet and Upholstery Cleaning Services (NAICS code 561740);
• Elementary and Secondary Schools (NAICS code 611110);
• Colleges, Universities, and Professional Schools (NAICS code 611310);
• Promoters of Performing Arts, Sports, and Similar Events with Facilities (NAICS code 711310);
• Drycleaning and Laundry Services (NAICS code 8123);
• Civic and Social Organizations (Primary) (NAICS code 813410);
• Business Associations (Primary) (NAICS code 813910);
• Other General Government Support (NAICS code 921190); and
• Administration of Air and Water Resource and Solid Waste Management Programs (Primary) (NAICS code 924110).
If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under
In 2023, EPA announced the availability of and sought public comment on several proposed changes to the existing Standard (88 FR 78017, November 14, 2023 (FRL-11518-01)) and held a public webinar on December 19, 2023, to present the Agency's proposed plans. EPA received 90 comments, representing 131 organizations or individuals. The Response to Comments document, which is available in the docket, is a compilation of the public comments received and EPA's responses. EPA's responses do not address each comment individually. EPA considered each comment and organized responses by section of the Standard.
After considering the public comments, EPA is issuing the final, updated Standard, which is available in the docket and on the Safer Choice website at
As part of its environmental mission, the Safer Choice program partners with businesses to help consumers and commercial buyers identify products with safer chemical ingredients, without sacrificing quality or performance. The Safer Choice program certifies products containing ingredients that have met the program's specific and rigorous human health and environmental toxicological criteria. The Safer Choice program allows companies to use its label on certified products that contain safer ingredients and perform, as determined by expert evaluation. The Safer Choice program certification represents a high level of achievement in formulating products that are safer for people and the environment. For more information on the Safer Choice program, please see:
The DfE program is a similar program currently used by EPA for the purpose of helping consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by FIFRA as well as meeting the DfE certification criteria (as described in the Standard). For more information on the DfE program, please see:
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with the Clean Air Act, as amended (CAA or the Act), notice is given of a proposed consent decree to address a lawsuit filed by Center for Biological Diversity, Sierra Club, and Center for Environmental Health (collectively, Plaintiffs) in the United States District Court for the Northern District of California:
Written comments on the proposed consent decree must be received by September 9, 2024.
Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2024-0319, online at
Melina Williams, Air and Radiation Law Office, Office of General Counsel, U.S. Environmental Protection Agency; telephone (202) 564-3406; email address
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2024-0319) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West,
The electronic version of the public docket for this action contains a copy of the proposed consent decree and is available through
The proposed consent decree would establish deadlines for EPA to take certain actions pursuant to CAA sections 108 and 109 to complete a review of the air quality criteria and the primary NAAQS for oxides of nitrogen. The proposed consent decree would require EPA to: issue a final Integrated Science Assessment, a document containing the air quality criteria, addressing human health effects of oxides of nitrogen no later than September 30, 2026; sign a notice setting forth its proposed decision concerning its review of the primary NAAQS for oxides of nitrogen no later than January 17, 2028; sign a notice setting forth its final decision concerning its review of the primary NAAQS for oxides of nitrogen no later than November 10, 2028; and, within 15 business days of issuance of the final Integrated Science Assessment, signature of the proposed decision, and signature of the final decision, respectively, send a notice to the Office of Federal Register for review and publication.
In accordance with section 113(g) of the CAA, for a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to the proposed consent decree. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act.
Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2024-0319, via
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.
Board of Governors of the Federal Reserve System (Board).
Notice.
The Economic Growth, Regulatory Relief, and Consumer Protection Act established at the Board an Insurance Policy Advisory Committee (IPAC). This Notice advises individuals who wish to serve as IPAC members of the annual opportunity to be considered for the IPAC.
Individuals who submit a Statement of Interest that is received by the Board from the first Monday in August through the first Monday in October of each year will be considered for appointments to the IPAC announced in the fourth calendar quarter of the same year. Statements of Interest received outside the period from the first Monday in August through the first Monday in October generally will not be considered.
Individuals seeking an appointment to the IPAC may send a Statement of Interest by email to
Individuals also may mail Statements of Interest and any additional information to the Board of Governors of the Federal Reserve System, Attn: Insurance Policy Advisory Committee,
Lara Lylozian, Deputy Associate Director and Chief Accountant, (202) 475-6656; Matt Walker, Manager, Insurance Supervision & Regulation, (202) 872-4971; or Joan Sullivan, Senior Insurance Policy Analyst, (202) 579-4987; Division of Supervision and Regulation; or
The Economic Growth, Regulatory Relief, and Consumer Protection Act established at the Board an Insurance Policy Advisory Committee (IPAC) to advise the Board on international capital standards and other insurance matters. This notice advises individuals of the opportunity to be considered for appointment to the IPAC. To assist with the appointment of IPAC members, the Board considers information submitted by the candidate, public information, and any other relevant information the Board determines to consider.
The IPAC has at most 21 members. IPAC members serve staggered three-year terms. Members are appointed to three-year terms unless the Board appoints a member to fill a vacant unexpired term. A member that is appointed to serve a three-year term begins his or her service on the first January 1 occurring after his or her appointment. A member appointed to fill a vacant unexpired term serves for the remainder of the term. The Board provides a nominal honorarium and reimburses members only for their actual travel expenses, subject to Board policy.
A Statement of Interest must contain the following information:
• Full name;
• Address;
• Phone number; and
• Email address.
At their option, candidates may provide additional information for consideration.
IPAC candidates should be insurance experts. The Board provides equal appointment opportunity to all persons without regard to race, color, religion, sex (including sexual orientation, gender identity, and pregnancy), national origin, age, disability, genetic information, or military service. In addition, the Board is committed to a diverse committee and seeks a diverse set of expert perspectives from the various sectors of the U.S. insurance industry including life insurance, property and casualty insurance and reinsurance, agents and brokers, academics, consumer advocates, and experts on issues facing underserved insurance communities and consumers. The Board also seeks relevant actuarial, legal, regulatory, and accounting expertise, as well as expertise on lines of business underwritten by its currently supervised population of insurance institutions.
Members must be willing and able to participate in conference calls and prepare for and attend meetings in person. Membership and attendance is not delegable.
By order of the Board of Governors of the Federal Reserve System, acting through the Director of the Division of Supervision and Regulation under delegated authority.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REZLIDHIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, REZLIDHIA (olutasidenib). REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test. Subsequent to this approval, the USPTO received a patent term restoration application for REZLIDHIA (U.S. Patent No. 9,834,539) from Forma Therapeutics, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 6, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of REZLIDHIA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for REZLIDHIA is 2,563 days. Of this time, 2,273 days occurred during the testing phase of the regulatory review period, while 290 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 440 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XOFLUZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical
FDA has approved for marketing the human drug product, XOFLUZA (baloxavir marboxil). XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Subsequent to this approval, the USPTO received a patent term restoration application for XOFLUZA (U.S. Patent No. 8,987,441) from Shionogi & Co., Ltd., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated December 23, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of XOFLUZA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for XOFLUZA is 985 days. Of this time, 801 days occurred during the testing phase of the regulatory review period, while 184 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 399 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that CIPRO (ciprofloxacin hydrochloride (HCl)) tablet, equivalent to (EQ) 100 milligrams (mg) base, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for ciprofloxacin HCl tablet, EQ 100 mg base.
Ayako Sato, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993-0002, 240-402-4191,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
On October 22, 1987, FDA approved NDA 019537 for CIPRO (ciprofloxacin HCl) tablet, EQ 250 mg base, 500 mg base, and 750 mg base. On April 8, 1996, FDA approved a supplement to NDA 019537 to add the tablet, EQ 100 mg base, to treat acute uncomplicated cystitis in adult females to be supplied as a cystitis pack containing six 100 mg oral tablets with a dosing regimen of 100 mg twice daily for 3 days.
On May 18, 2005, FDA approved labeling revisions for NDA 019537, including updates to reflect that the 100 mg tablet drug product was no longer being marketed. CIPRO (ciprofloxacin HCl) tablet, EQ 100 mg base, was moved from the “Prescription Drug Product List” to the “Discontinued Drug Product List” section of the Orange Book. Subsequently, the Agency made a safety and effectiveness determination that CIPRO (ciprofloxacin HCl) tablet, EQ 100 mg base, was not discontinued for reasons of safety or effectiveness, which was later published in the
The resistance of
On June 16, 2023, the Agency notified Bayer HealthCare Pharmaceuticals Inc. (Bayer) that it believed the potential problems associated with the drug product are sufficiently serious that the EQ 100 mg base strength product should be removed from the market pursuant to § 314.150(d) (21 CFR 314.150(d)). Bayer requested in a letter dated July 7, 2023, that FDA withdraw approval of the EQ 100 mg base strength product in NDA 019537 under § 314.150(d) and waived its opportunity for a hearing. FDA also notified application holders for ANDAs 075593, 075817, 075939, and 076794 on June 16, 2023, and for ANDA 076912 on June 21, 2023. FDA asked the ANDA holders to request withdrawal of approval under § 314.150(d) of the generic versions of ciprofloxacin HCl tablet, EQ 100 mg base, and to waive their opportunity for a hearing.
Consistent with requests from the relevant application holders, in the
After reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CIPRO (ciprofloxacin HCl) tablet, EQ 100 mg base, for the treatment of acute uncomplicated cystitis was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CIPRO (ciprofloxacin HCl) tablet, EQ 100 mg base, for the treatment of acute uncomplicated cystitis from sale. We have also independently evaluated relevant literature and data. We have reviewed the available evidence. Given that the safe and effective use of ciprofloxacin HCl tablet, 100 mg twice daily for 3 days for the treatment of acute uncomplicated cystitis is not supported by its current STIC and considering the risks of serious adverse reactions along with the increased resistance of
Accordingly, under § 314.162 the Agency will remove Bayer's NDA 019537 for CIPRO (ciprofloxacin HCl) tablet, EQ 100 mg base, for the treatment of acute uncomplicated cystitis from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. Likewise, the Agency will
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 October 7, 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
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,
The draft survey instrument is available upon request from
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
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 request supports Agency research authorized by section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) and section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)).
The mission of the Office of Prescription Drug Promotion (OPDP) is to protect public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and the characteristics of the disease and product impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience. Our focus on research quality aims at maximizing the quality of our research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first topic area: advertising features.
Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage at
This current project will be a survey with a selection of prescribers examining a variety of topics of interest to OPDP. The prescriber sample will be primary care physicians (PCPs) (in family practice, general practice, or internal medicine), nurse practitioners and physician assistants (NP/PAs), and specialists (cardiology, dermatology, endocrinology, neurology, obstetrics/gynecology, oncology, ophthalmology, psychiatry, rheumatology, and urology). Topics we plan to assess include, but are not limited to, awareness and use of the Bad Ad program (Refs. 1 and 2), understanding of quantitative data displays that may appear in prescription drug promotion (Refs. 3 and 4), perceptions of trust in FDA, perceptions of medical misinformation (Refs. 5 and 6), and attitudes about prescription drug promotion on social media (Refs. 7 and 8). These topics were selected to extend previous FDA work on healthcare provider understanding of quantitative data displays, provide an updated snapshot of social media attitudes and Bad Ad program awareness, and help inform FDA's role in addressing medical misinformation (Ref. 9).
We estimate that participation in the survey will take approximately 20 minutes. Our target respondents are adult voluntary participants who are PCPs, NP/PAs, or specialists engaging in patient care at least half time, with a range of gender, race and ethnicity, and ages that reflects the composition of the American Medical Association. Participants will be recruited by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. We will exclude individuals who are employees of the Department of Health and Human Services and individuals who work for a marketing, advertising, or pharmaceutical firm.
The target sample size for the survey is 2,410 respondents. Before conducting the survey, we will conduct up to two pretests. If the first pretest wave reveals that changes to the measurement instruments, stimuli, or procedures are required, a second pretest wave will be conducted with revised materials. The target sample size for Pretest 1 is 75 respondents and for Pretest 2 is 50 respondents.
We estimate the burden of this collection of information as follows:
The following references are on display at the Dockets Management Staff (see
1. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al., “Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings,”
2. Betts, K.R., A.C. O'Donoghue, M. Johnson, et al., “Detecting and Reporting Deceptive Prescription Drug Promotion: Differences Across Consumer and Physician Audiences and by Number and Type of Deceptive Claims and Tactics,”
3. Thompson, J., M. Lynch, H.W. Sullivan, et al., “Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers,”
4. Thompson, J., R.C. Wines, M. Brewington, et al., “Healthcare Providers' Understanding of Data Displays of Clinical Trial Information: A Scoping Review of the Literature,”
5. Goldwire, M.A., S.T. Johnson, M. Abdalla, et al., “Medical Misinformation: A Primer and Recommendations for Pharmacists,”
6. Boudewyns, V., B.G. Southwell, K.R. Betts, et al., “Awareness of Misinformation in Health-Related Advertising: A Narrative Review of the Literature,”
7. Campbell, B.C. and C.M. Craig, “Social Media and Health: Current and Future Healthcare Provider Perspectives,”
8. Betts, K.R., A.C. O'Donoghue, K.J. Aikin, et al., “Professional Online Community Membership and Participation Among Healthcare Providers: An Extension to Nurse Practitioners and Physician Assistants,”
9. Califf, R.M., “Speech by Commissioner Robert M. Califf to the House of Medicine,” June 16, 2023,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) 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 September 9, 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 helps support implementation of statutory and regulatory authorities governing the export of certain FDA-regulated products found in section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), and in 21 CFR part 1, subpart E—Imports and Exports, of Agency regulations. Some countries may require manufacturers of FDA-regulated products to provide certificates for products they wish to export to that country. Accordingly, firms exporting products from the United States often ask FDA to provide such a “certificate.” In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States, or that they meet specific U.S. requirements. In some cases, review of an FDA export certificate may be required as part of the process to register or import a product into another country. An export certificate generally indicates that the particular product is marketed in the United States or otherwise eligible for export and that
Consistent with this authority, interested persons may request human food and cosmetic export certificates electronically via the Export Certification Application and Tracking System (eCATS) or Certificate Application Process (CAP), components of the FDA Industry Systems, or by contacting FDA for assistance. Health certificates are the exception and are requested via email. To facilitate the application process, we have eliminated paper-based forms. All information is currently submitted electronically using Forms FDA 3613d, 3613e, and 3613k. The eCATS Module is Form 3613k, where 3613e is the Certificate of Free Sale (
While a burden associated with information collection activities for export certificates issued for other FDA regulated products is accounted for and approved under OMB control number 0910-0498, this collection specifically supports information collection activity attributable to export certificates issued for human food and cosmetic products. Also, because we have eliminated paper-based forms, respondents who require assistance with completing export certificate applications online may contact FDA directly by email (
We are revising the information collection to include a web-based inquiry form, Form FDA 5077, entitled “U.S. Department of Health and Human Services Food and Drug Administration Export Certification Inquiry,” intended to facilitate processing by cross-referencing the request with existing Agency data. A mockup of the proposed electronic form is posted to the docket to solicit public comment. For food products, respondents may identify facilities using their Food Facility Registration number, FDA Establishment Identifier number, or a Data Universal Numbering System number. The system uses these identifiers to locate and auto-populate name and address information, eliminating the need for users to manually enter this information and reducing the time to complete the application. For some applications, respondents can also upload product information via a spreadsheet, which reduces the time needed to enter product information, particularly for applications that include multiple products.
In the
We therefore estimate the burden of the collections of information as follows:
Since our last review of the information collection, we have adjusted our estimate of the number of respondents downward. At the same time, we have increased the number of responses per respondent and added new Form FDA 5077. Cumulatively these activities result in an estimated burden increase of 2,433 hours and 9,547 responses annually.
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on September 9, 2024, from 9 a.m. to 4 p.m. Eastern Time.
The public may attend the meeting at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2024-N-3538. The docket will close on September 6, 2024. Please note that late, untimely filed comments will not be considered. The
Comments received on or before August 29, 2024, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
Submit electronic comments in the following way:
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• 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:
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• 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.” FDA 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
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-2855, email:
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference
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FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner (see
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in the table are no longer being marketed.
FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the drug products listed are unaffected by the discontinued marketing of the products subject to these applications. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice of availability; reopening the comment period.
The Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the proposed administrative order (proposed order) entitled “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use”, announced in the
FDA is reopening the comment period on proposed order (OTC000035) announced in the
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:
•
Helen Lee, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0138.
In the
Interested persons were originally given until July 29, 2024, to comment on the proposed order (OTC000035) via the OTC Monographs@FDA portal. However, as of June 14, 2024, technical difficulties prevented the electronic submission of comments through the OTC Monographs@FDA portal. Therefore, we are reopening the comment period for the proposed order (OTC000035) and are instead accepting comments through the Federal eRulemaking Portal. Accordingly, submit comments on the proposed order (OTC000035) electronically using Docket No. FDA-2024-N-2422 in the Federal eRulemaking Portal at
The proposed order (OTC000035) remains available in the OTC Monographs@FDA portal at
Food and Drug Administration, HHS.
Notice; renewal of Federal advisory committee.
The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 13, 2026, expiration date.
Authority for the Blood Products Advisory Committee will expire on May 13, 2026, unless the Commissioner formally determines that renewal is in the public interest.
Christina Vert, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 240-731-3544,
Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Blood Products Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs of its findings regarding screening and testing (to determine eligibility) of donors and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological products licenses, and on the quality and relevance of FDA's research program, which provides the scientific support for regulating these agents.
The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the Committee recommends
The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other related professions. 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-Officios. 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 Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, in connection with a particular committee meeting, specify a quorum that is less than most of the current voting members. The Agency's regulations (21 CFR 14.22(d)) authorize a committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting representative member of consumer interests and an additional non-voting representative member of industry interests will be included in addition to the voting members.
Further information regarding the most recent charter and other information can be found at
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VANFLYTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, VANFLYTA (quizartinib). VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication-positive as detected by an FDA-approved test. Subsequent to this approval, the USPTO received patent term restoration applications for VANFLYTA (U.S. Patent Nos. 7,820,657; 8,129,374; 8,357,690; 8,557,810; and 8,836,218) from Ambit Biosciences Corporation, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 24, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VANFLYTA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for VANFLYTA is 6,110 days. Of this time, 5,779 days occurred during the testing phase of the regulatory review period, while 331 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,781 days or 1,826 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TALZENNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6200, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, TALZENNA (talazoparib tosylate). TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. Subsequent to this approval, the USPTO received a patent term restoration application for TALZENNA (U.S. Patent No. 8,012,976) from Medivation Technologies LLC, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated December 23, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of TALZENNA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for TALZENNA is 2,869 days. Of this time, 2,675 days occurred during the testing phase of the regulatory review period, while 194 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,093 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INPEFA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, INPEFA (sotagliflozin). INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. Subsequent to this approval, the USPTO received patent term restoration applications for INPEFA (U.S. Patent No. 7,781,577 and 8,217,156) from Lexicon Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 30, 2024, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of INPEFA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for INPEFA is 5,268 days. Of this time, 4,903 days occurred during the testing phase of the regulatory review period, while 365 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 5 years of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of two abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holder to request a hearing on this proposal. The basis for the proposal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.
The ANDA holder may submit a request for a hearing by September 9, 2024. Submit all data, information, and analyses upon which the request for a hearing relies October 7, 2024. Submit electronic or written comments by October 7, 2024.
The request for a hearing may be submitted by the ANDA holder by either of the following methods:
Submit electronic comments in the following way:
•
Submit written/paper submissions as follows:
•
• Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. The request for a hearing must include the Docket No. FDA-2024-N-3271 for “Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing.” The request for a hearing will be placed in the docket and publicly viewable at
• Confidential Submissions—To submit any data analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analyses. 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 any decisions on this matter. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
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
Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-3471,
The holder of an approved ANDA to market a new drug for human use is required to submit annual reports to FDA concerning its approved ANDA under §§ 314.81 and 314.98 (21 CFR 314.81 and 314.98). The holder of the approved ANDAs listed in table 1 have repeatedly failed to submit the required annual reports and have not responded to the Agency's request for submission of the reports.
Therefore, under 21 CFR 314.150(b)(1) and § 314.200 (21 CFR 314.200), notice is given to the holder of the approved ANDAs listed in table 1 and to all other interested persons that the Director of CDER proposes to issue an order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of the ANDAs and all amendments and supplements thereto on the grounds that the ANDA holder has failed to submit reports required under §§ 314.81 and 314.98.
In accordance with section 505 of the FD&C Act and part 314 (21 CFR part 314), the ANDA holder is hereby provided an opportunity for a hearing to show why the approval of the ANDAs listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these ANDAs.
An ANDA holder who decides to seek a hearing must file the following: (1) a written notice of participation and request for a hearing (see
The failure of an ANDA holder to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that ANDA holder not to avail itself of the opportunity for a hearing concerning CDER's proposal to withdraw approval of the ANDAs and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the ANDAs, and the drug products may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved ANDA is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or denials but must present specific facts showing that
All submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen at the Dockets Management Staff (see
This notice is issued under section 505(e) of the FD&C Act and under authority delegated to the Director of CDER by the Commissioner of Food and Drugs.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the Fiscal Year 2025 CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.
Starting October 1, 2024, FDA will accept requests to participate in the ELSVP program.
If your facility is interested in offering a site visit, submit either an electronic proposal to
Lyle Canida, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. M4522, Silver Spring, MD 20993-0002, 301-796-6825, email:
A critical part of the commitment by CDER to assure safe and effective high-quality drugs are available to the American public is gaining an understanding of all aspects of a drug's development and commercial lifecycle, including the variety of drug manufacturing operations. To support this commitment, CDER has initiated various training and development programs, including the FY2025 OPQ ELSVP. This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that may impact a drug's developmental program and commercial life cycle. The goal of these visits is to enhance OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities, including manufacturing and laboratory operations, is an integral part of the experience.
In this site visit program, groups on average of no more than 15 OPQ staff—who have experience in a variety of educational backgrounds, supporting pharmaceutical quality assessment—will observe operations or important aspects of commercial manufacturing, pilot plants (if applicable), and testing over a 1- to 2-day period. To facilitate the learning process for OPQ staff, overview presentations by industry related to drug development, manufacturing, and testing may be included.
CDER encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to respond.
OPQ staff participating in this program will benefit by gaining a better understanding of current industry practices, processes, and procedures. Participating sites will have an opportunity to showcase their technologies and their actual manufacturing and testing facilities.
Although observation of all aspects of drug development and production would be beneficial to OPQ staff, the following list identifies a number of areas of particular interest to its staff. The list is not intended to be exhaustive, mutually exclusive, or to limit industry response:
• Drug products:
• Active pharmaceutical ingredients manufactured by:
• Design, development, manufacturing, and controls:
• Advanced manufacturing technologies:
• Terminal sterilization:
Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility's current compliance status with FDA, and in consultation with the appropriate FDA district office. All travel expenses associated with this program will be the responsibility of CDER Offices; therefore, the number of sites selected will be based on the availability of funds and resources for the fiscal year. FDA will not provide financial compensation to the pharmaceutical site as part of this program.
Companies interested in offering a site visit or learning more about this site
• A contact person,
• Site visit location(s),
• Facility Establishment Identifier and D-U-N-S numbers, as applicable,
• Maximum number of FDA staff that can be accommodated during a site visit (maximum of 15, on average),
• A proposed agenda outlining the learning objectives and associated activities for the site visit,
• Maximum number of site visits your site would be willing to host by the close of the Government fiscal year, September 30, 2025, and
• Proposed time frames for each site visit (
Please note that the requested proposed agenda will be reviewed to determine the educational benefit to OPQ in conducting the visit, and selected sites may be asked to refine the agenda to maximize the educational benefit. After a site is selected, OPQ will communicate with the contact person for the site to determine the actual dates for the visit.
Proposals submitted without this minimum information will not be considered. Based on response rate and type of responses, OPQ may consider alternative pathways to meeting our training goals.
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 8W-25A, Rockville, Maryland 20857; (301) 443-6593, or visit our website at:
The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of title XXI of the PHS Act, 42 U.S.C. 300aa-10
A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the
Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:
1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and
2. Any allegation in a petition that the petitioner either:
a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or
b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.
In accordance with section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the United States Court of Federal Claims at the address listed above (under the heading
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice of non-competitive supplemental funding.
HRSA is providing non-competitive supplemental funds in
India Hinton, Public Health Analyst, Division of Healthy Start and Perinatal Services, Maternal and Child Health Bureau, HRSA, at
HRSA will award a non-competitive supplement not to exceed $1.8 million to support the implementation of community-based activities, to include maternal safety bundles and supporting resources, with a focus on hypertension during pregnancy and the postpartum period. Lessons learned from the pilot will be used to strengthen and inform community-based approaches targeting hypertension in pregnant and postpartum people.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice of supplemental funding.
HRSA will provide a performance period extension with supplemental funds to one Health Center Program award recipient with a period of performance ending in fiscal year 2025. The supplemental funding will extend their current period of performance by 12 months to prevent interruptions in access to critical primary health care services in the community.
Erica Clift, HSRA, 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.
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-0361.
42 CFR part 8 establishes a certification program managed by SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation requires that opioid treatment programs (OTPs) be certified. “Certification” is the process by which SAMHSA determines that an OTP is qualified to provide opioid use disorder treatment under the federal opioid use disorder treatment standards established by the Secretary of Health and Human Services. To become certified, an OTP must be accredited by a SAMHSA-approved accreditation body. The regulation also provides standards for such services as individualized treatment planning, increased medical supervision, and assessment of patient outcomes. This submission seeks continued approval of the information collection requirements in the regulation and of the forms used in implementing the regulation.
SAMHSA currently has approval for the
SAMHSA believes that the recordkeeping requirements in the regulation are customary and usual practices within the medical and rehabilitative communities and has not calculated a response burden for them. The recordkeeping requirements set forth in 42 CFR 8.4, 8.11 and 8.12 include maintenance of the following:5-year retention by accreditation bodies of certain records pertaining to accreditation; documentation by an OTP of the following: a patient's medical examination when admitted to treatment, a patient's medical history, a care plan, any prenatal support provided the patient if applicable, the medical rationale for initial starting doses above 50mg, the medical rationale for a patient's dosage schedule, and care decisions made as a result of follow-up medical examinations.
The table that follows summarizes the annual reporting burden associated with the regulation, including burden associated with the forms. There are minor changes to these forms to improve data collection, remove unnecessary questions, and align terms with the final 42 CFR part 8 rule released February 2, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Kansas (FEMA-4774-DR), dated April 28, 2024, and related determinations.
This change occurred on July 10, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Andrew P. Meyer, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.
This action terminates the appointment of DuWayne Tewes as Federal Coordinating Officer for this disaster.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA-4796-DR), dated June 24, 2024, and related determinations.
This amendment was issued July 9, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Iowa is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 24, 2024.
Woodbury County for Individual Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA-4796-DR), dated June 24, 2024, and related determinations.
This amendment was issued July 5, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Iowa is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 24, 2024.
Buena Vista and O'Brien Counties for Individual Assistance (already designated for debris removal and emergency protective measures (Categories A and B), including direct Federal assistance, under the Public Assistance program).
Cherokee County for Individual Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Kansas (FEMA-4774-DR), dated April 28, 2024, and related determinations.
This amendment was issued June 27, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Kansas is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of April 28, 2024.
Marion County for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4781-DR), dated May 17, 2024, and related determinations.
This amendment was issued July 8, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 17, 2024.
Anderson, Panola, and Rusk Counties for Individual Assistance (already designated for Public Assistance).
Nacogdoches and Sabine Counties for Individual Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-4794-DR), dated June 17, 2024, and related determinations.
This amendment was issued July 16, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 17, 2024.
Columbia County for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4781-DR), dated May 17, 2024, and related determinations.
This amendment was issued July 15, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 17, 2024.
Blanco, Cass, Cherokee, Gonzales, Hopkins, McCulloch, Morris, Rains, and Titus Counties for Public Assistance.
Dallas and Sabine Counties for Public Assistance (already designated for Individual Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4798-DR), dated July 9, 2024, and related determinations.
This amendment was issued July 12, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include Individual Assistance for the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of July 9, 2024.
Brazoria, Chambers, Galveston, Harris, Jackson, Jasper, Jefferson, Liberty, Matagorda, Montgomery, Orange, Polk, San Jacinto, Walker, and Wharton Counties for Individual Assistance (already designated for debris removal and emergency protective measures (Categories A and B), including direct Federal assistance, under the Public Assistance program).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Massachusetts (FEMA-4780-DR), dated May 15, 2024, and related determinations.
This amendment was issued July 1, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the Commonwealth of Massachusetts is hereby amended to include Disaster Legal Services for the areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 15, 2024.
Bristol and Worcester Counties for Disaster Legal Services.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-4794-DR), dated June 17, 2024, and related determinations.
This amendment was issued June 27, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 17, 2024.
Jefferson and Santa Rosa Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of West Virginia (FEMA-4787-DR), dated May 24, 2024, and related determinations.
This amendment was issued July 3, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of West Virginia is hereby amended to include the Individual Assistance program for the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 24, 2024.
Hancock, Marshall, Ohio, and Wetzel Counties for Individual Assistance (already designated for Public Assistance).
Kanawha, Roane, and Wood Counties for Individual Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4781-DR), dated May 17, 2024, and related determinations.
This amendment was issued July 1, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 17, 2024.
Anderson, Baylor, Cochran, Delta, Milam, Rockwall, and Rusk Counties for Public Assistance.
Henderson, Kaufmann, and Van Zandt Counties for Public Assistance (already designated for Individual Assistance).
Ellis, Guadalupe, and Smith Counties for emergency protective measures (Category B), limited to direct federal assistance under the Public Assistance program (already designated for Individual Assistance).
Hays and Hill Counties for emergency protective measures (Category B), limited to direct federal assistance under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Oklahoma (FEMA-4791-DR), dated June 14, 2024, and related determinations.
This amendment was issued July 16, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Oklahoma is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 14, 2024.
Caddo, Custer, and Jackson Counties for Public Assistance (already designated for Individual Assistance).
Roger Mills and Woods Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA-4784-DR), dated May 24, 2024, and related determinations.
This amendment was issued June 27, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Iowa is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 24, 2024.
Adair County for permanent work [Categories C-G] (already designated for Individual Assistance and assistance for debris removal and emergency protective measures under the Public Assistance program).
Adams, Cedar, Jasper, Montgomery, Polk, and Story Counties for Public Assistance (already designated for Individual Assistance).
Buena Vista, Butler, Calhoun, Cherokee, Clay, Dallas, Franklin, Hamilton, Hancock, Harrison, Humboldt, Iowa, Jackson, Kossuth, Marshall, Mitchell, Muscatine, Pottawattamie, Poweshiek, Shelby, Tama, and Wright Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4798-DR), dated July 9, 2024, and related determinations.
This amendment was issued July 13, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of July 9, 2024.
Fort Bend and Nacagdoches Counties for Individual Assistance (already designated for debris removal and emergency protective measures (Categories A and B), including direct Federal assistance, under the Public Assistance program).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Minnesota (FEMA-4797-DR), dated June 28, 2024, and related determinations.
This amendment was issued July 11, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this disaster is closed effective July 4, 2024.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of New Mexico (FEMA-4795-DR), dated June 20, 2024, and related determinations.
This amendment was issued July 11, 2024.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of New Mexico is hereby amended to include the following areas among the areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of June 20, 2024.
Lincoln and Otero Counties, including the Mescalero Apache Tribe for permanent work [Categories C-G] (already designated for Individual Assistance and assistance for debris removal and emergency protective measures [Categories A and B], including direct federal assistance, under the Public Assistance program).
Rio Arriba and San Juan Counties for Individual Assistance.
Rio Arriba and San Juan Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), have received two applications for incidental take permits (ITPs) for the federally threatened Central California Distinct Population Segment (DPS) of the California tiger salamander and California red-legged frog under the Endangered Species Act of 1973, as amended. Each of the two applicants submitted a permit application which, if issued, would authorize take of the California tiger salamander and California red-legged frog incidental to activities associated with the development and improvement of school facilities in the cities of San Juan Bautista and Salinas in San Benito and Monterey Counties, respectively, in California. As part of the application for an ITP, each applicant submitted a draft habitat conservation plan for their respective project. For each project, the Service prepared a draft screening form in accordance with the National Environmental Policy Act (NEPA) to evaluate the potential effects to the natural and human environment resulting from issuing an ITP to each applicant for their project. We invite the public and local, State, Tribal, and Federal agencies to comment on the draft screening forms and on the Service's preliminary determination that the proposed permitting actions may be eligible for categorical exclusions pursuant to the Council on Environmental Quality's NEPA regulations, the Department of the Interior's (DOI) NEPA regulations, and the DOI Departmental Manual.
Written comments should be received on or before September 9, 2024.
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Karen Sinclair, Fish and Wildlife Biologist, by email at
We, the U.S. Fish and Wildlife Service (Service), have received two applications for incidental take permits (ITPs) under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
The Service listed the Central California DPS of the California tiger salamander as threatened on August 4, 2004 (69 FR 47212), and listed the California red-legged frog as threatened on May 23, 1996 (61 FR 25813). Section 9 of the ESA prohibits “take” of fish and wildlife species listed as endangered (16 U.S.C. 1538), where take is defined to include the following activities: “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct” (16 U.S.C. 1532). The take prohibitions of section 9 are extended to species listed as threatened at the discretion of the Secretary of the Department of the Interior; in this case, they were extended to both species; however, this was done with exceptions for the California tiger salamander.
Under section 10(a)(1)(B) of the ESA (16 U.S.C. 1539(a)(1)(B)), we may issue permits to authorize take of listed fish and wildlife species that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing incidental take permits for endangered and threatened species are in the Code of Federal Regulations (CFR) at 50 CFR 17.22 and 17.32, respectively. Issuance of an ITP also must not jeopardize the existence of federally listed fish, wildlife, or plant species, pursuant to section 7 of the ESA and 50 CFR 402.02. The permittee would receive assurances under our “No Surprises” regulations (50 CFR 17.22(b)(5) and 17.32(b)(5)).
Each applicant has applied for a permit for incidental take of the California tiger salamander and California red-legged frog. The take would occur in association with development and improvement activities of school facilities.
The respective HCPs include minimization measures for the California tiger salamander and California red-legged frog and mitigation for unavoidable take and loss of suitable habitat for these species. As mitigation for take and loss of suitable habitat, the applicants propose mitigation that will support the recovery goals of the species such as restoration and protection of habitat through the purchase of credits at a conservation bank.
The Service has made a preliminary determination that the applicants' proposed projects, and proposed mitigation and minimization measures, would individually and cumulatively have a minor effect on the species and the human environment. Therefore, we have preliminarily determined that the proposed ESA section 10(a)(1)(B) permits would be low-effect ITPs that individually or cumulatively would have a minor effect on the species and may qualify for application of categorical exclusions pursuant to the Council on Environmental Quality's NEPA regulations, DOI's NEPA regulations, and the DOI Departmental Manual. A low-effect ITP is one that would result in (1) minor or nonsignificant effects on species covered in the HCP; (2) nonsignificant effects on the human environment; and (3) impacts that, when added together with the impacts of other past, present, and reasonably foreseeable actions, would not result in significant cumulative effects to the human environment.
The Service will evaluate the applications and the comments received to determine whether to issue the requested ITPs. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA to evaluate the effects of the proposed covered activities on the Central California DPS of the California tiger salamander and California red-legged frog. After considering the preceding and other matters, we will determine whether the permit issuance criteria of section 10(a)(1)(B) of the ESA have been met. If met, the Service will issue one or both ITPs.
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 view, we cannot guarantee that we will be able to do so.
We provide this notice under section 10(c) of the Endangered Species Act (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of call for nominations.
The purpose of this notice is to request public nominations for the Bureau of Land Management's (BLM) Western Montana Resource Advisory Council (RAC) to fill existing vacancies, as well as for member terms that are scheduled to expire. The RAC provides advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within the Western Montana District.
All nominations must be received no later than September 9, 2024.
Nominations and completed applications should be sent to the BLM office listed in the
Ann Boucher, BLM Montana/Dakotas State Office, 5001 Southgate Drive, Billings, MT 59101; telephone: (406) 896-5255; email:
Individuals in the United States who are deaf, blind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
The Federal Land Policy and Management Act (FLPMA) directs the Secretary of the Interior (Secretary) to involve the public in planning and issues related to the management of lands administered by the BLM. Section 309 of FLPMA (43 U.S.C. 1739) directs the Secretary to establish 10- to 15-member citizen-based advisory councils that are consistent with the Federal Advisory Committee Act (FACA). As required by FACA, RAC membership must be balanced, and representative of the various interests concerned with the management of the public lands. The rules governing RACs are found at 43 CFR part 1780 and include the following three membership categories:
Individuals may nominate themselves or others. Nominees must be residents of the State of Montana. The BLM will evaluate nominees based on their education, training, experience, and knowledge of the geographic area of the RAC. Nominees should demonstrate a commitment to collaborative resource decision-making.
The following must accompany all nominations:
• A completed RAC application, which can either be obtained through the nominee's BLM office or online at:
• Letters of reference from represented interests or organizations; and
• Any other information that addresses the nominee's qualifications.
Simultaneous with this notice, the BLM Montana/Dakotas office will issue an online announcement providing additional information for submitting nominations.
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Missouri Basin Resource Advisory Council (RAC) will meet as follows.
The Missouri Basin RAC will meet on September 11, 2024, from 12 p.m. to 5 p.m. Mountain Time.
The meeting will be held at the Glasgow City-County Library, 408 3rd Avenue South, Glasgow, MT 59230. A virtual participation option will also be available. Individuals who wish to participate virtually must register with the contact person listed below at least 7 business days prior to the meeting date.
Gina Baltrusch, Missouri Basin RAC Coordinator, BLM North Central Montana District, 1220 38th Street North, Great Falls, MT 59405; telephone: 406-308-9387; email:
Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. Please make requests in advance for sign language interpreter services, language translation services, assistive listening devices, or other reasonable accommodations. We ask that you contact the person listed above at least 14 business days prior to the meeting to give the BLM sufficient time to process your request. All reasonable accommodation requests are managed on a case-by-case basis.
The 15-member RAC advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Central and Eastern Montana, and North and South Dakota. Agenda topics will include North-Central Montana and Eastern Montana/Dakotas districts' reports, Field Office manager reports, a public comment period, and other topics the council may wish to cover. A final agenda will be posted on the RAC's web page at
Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment, including your personally identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Central California Resource Advisory Council (RAC) will meet as follows.
The Central California RAC will hold virtual public meetings on Wednesday, September 11, 2024, from 8:30 a.m. to 2:15 p.m. Pacific Time (PT), with a public comment period scheduled for 1:45 p.m. PT; and on Wednesday, February 5, 2025, from 8:30 a.m. to 12:30 p.m. PT, with a public comment period scheduled for 12:00 p.m. PT; and an in-person meeting on Wednesday, May 8, 2025, from 8:30 a.m. to 2:15 p.m. PT, with a public comment period scheduled for 1:45 p.m. PT. A field tour will be held on May 7, 2025, from 12:30 p.m. to 5 p.m. PT. The meetings and field tour are open to the public.
Meeting links, final agendas, and participation instructions will be made available to the public via social media, the BLM Central California RAC's website at
Public Affairs Officer, Philip Oviatt, email:
The chartered 12-member Central California RAC advises the Secretary of the Interior, through the BLM California State Director, on planning and management of public land resources located within the jurisdictional boundaries of the RAC. Agenda topics for the September 11, 2024, meeting include a briefing on Alabama Hills Management Plan implementation as well as an update on the Bi-State Sage Grouse program. The RAC will also hear reports from the district and field offices. In addition, the RAC will hear a fee proposal from the United States Department of Agriculture (USDA) Forest Service for sites in the Inyo National Forest. Agenda topics for the February 5, 2025, meeting include a briefing on habitat and watershed restoration projects in the Mother Lode Field Office. The RAC will also be briefed on fuels reduction projects as well as briefings from the district and field offices, including a wildland fire update.
On May 7, 2025, the RAC will tour the Diablo Canyon Fuels Reduction Project with partners in San Luis Obispo County. Members of the public are welcome to participate in the field tour but must provide their own transportation and meals. Agenda topics for the May 8, 2025, meeting include the Bakersfield Fuels Reduction Program, and the RAC will receive an update on the Bakersfield Oil and Gas Program. The RAC will also hear reports from the district and field offices. In addition, the RAC will hear a fee proposal from the USDA Forest Service for a site in the Los Padres National Forest. Members of the public who wish to participate in the field tour must provide their own transportation and meals.
Each formal RAC meeting will have time allocated for public comments. Depending on the number of persons wishing to speak and the time available, the amount of time for oral comments may be limited. Written public comments may be sent to the BLM Central California District Office listed in the
Detailed minutes for the RAC meetings will be maintained in the BLM Central California District Office. Minutes will also be posted to the BLM California RAC web page.
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Interested persons are invited to submit comments on or before September 9, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request additional information about this ICR, contact Mark Gehlhar by email at
In accordance with the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501
A
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. 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
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of JBS Hair, Inc. on August 2, 2024. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain certain pre-stretched synthetic braiding hair and packaging therefor. The complaint names as respondents: Sun Taiyang Co., Ltd. (d/b/a Outre®) of Moonachie, NJ; Beauty Elements Corporation (d/b/a Bijouz®) of Miami Gardens, FL; Hair Zone, Inc. (d/b/a Sensationnel®) of Moonachie, NJ; Beauty Essence, Inc. (d/b/a Supreme
Proposed respondents, other interested parties, members of the public, and interested government agencies are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3764”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Drug Enforcement Administration, Justice.
Notice of application.
Experic 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 September 9, 2024. Such persons may also file a written request for a hearing on the application on or before September 9, 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 June 10, 2024, Experic LLC, 2 Clarke Drive, Cranbury, New Jersey 08512-3619, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import drug code Tetrahydrocannabinols (7370) for clinical trial purposes. No other activity for this drug code is 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.
Cambrex High Point, Inc., 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 September 9, 2024. Such persons may also file a written request for a hearing on the application on or before September 9, 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 July 25, 2024, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, 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 research and development purposes. No other activity for this drug code is 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-
Drug Enforcement Administration, Justice.
Notice of application.
AMPAC Fine Chemicals, 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 October 7, 2024. Such persons may also file a written request for a hearing on the application on or before October 7, 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 May 29, 2024, AMPAC Fine Chemicals, LLC, Highway 50 & Hazel Avenue, Rancho Cordova, California 95670, 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 distribution to its customers. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Cambrex Charles City 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 October 7, 2024. Such persons may also file a written request for a hearing on the application on or before October 7, 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 June 18, 2024, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sales to its customers for dosage form development, clinical trials and use in stability qualification studies.
In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Catalent Greenville, Inc., 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 September 9, 2024. Such persons may also file a written request for a hearing on the application on or before September 9, 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 July 12, 2024, Catalent Greenville, Inc., 1240 Sugg Parkway, Greenville, North Carolina 27834-9006, 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 the development of bulk dosage formulations for research and clinical studies. No other activity for this drug code is 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.
Benuvia Operations, LLC., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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 September 9, 2024. Such persons may also file a written request for a hearing on the application on or before September 9, 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 June 14, 2024, Benuvia Operations, LLC., 3950 North Mays Steet, 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. 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.
VICI Health Sciences, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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 October 7, 2024. Such
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 May 15, 2024, VICI Health Sciences, LLC, 6655 Amberton Drive, Suite O, Elkridge, Maryland 21075, 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 substance for sale to its customers. No other activity for this drug code is authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Cerilliant Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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 September 9, 2024. Such persons may also file a written request for a hearing on the application on or before September 9, 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 June 21, 2024, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402, 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 the manufacturing of analytical reference standards and distribution to their research and forensic customers. 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.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-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 September 9, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this
Nicole Bouchet by telephone at 202-693-0213, or by email at
The Standard on Steel Erection requires that workers exposed to fall hazards receive specified training in the recognition and control of these hazards and that they are notified that building materials, components, steel structures, and fall protection equipment are safe for specific uses. 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.
Chief Evaluation Office, Office of the Assistant Secretary for Policy, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents is properly assessed. Currently, the Department of Labor is soliciting comments concerning the collection of data for the National Worker Survey. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed below in the addressee section of this notice.
Written comments must be submitted to the office listed in the addressee section below on or before October 7, 2024.
You may submit comments by either one of the following methods:
Kacie Chang by email at
I.
Violations of the FLSA are not uncommon. In a survey of 4,387 workers in low-wage industries in Chicago, Los Angeles, and New York City, two-thirds experienced at least one pay-related violation in any given week (Bernhardt, A., Milkman, R. and Theodore, N. 2009. Broken laws, unprotected workers: Violations of employment and labor laws in America's cities. National Employment Law Project, New York, NY). The actual extent of violations is unknown and must be estimated through surveys. Existing national surveys do a poor job of including workers who are at the highest risk of violations and are generally able to measure only minimum wage violations due to the way questions are asked. Given DOL's limited resources to investigate individual complaints, it is important to have nationally representative data on prevalence across industries and worker subpopulations to prioritize enforcement. The current study will build on the work of previous surveys by designing a nationally representative survey of workers with oversamples of workers in low-wage industries where violations are most likely to occur. The study will provide DOL with information it needs to promote compliance with the FLSA as well as outreach and education to raise awareness among vulnerable workers about the types of pay practices and other actions used by employers who violate the FLSA.
This
II.
○ evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
○ evaluate the accuracy of the agency's burden estimate of the proposed information collection, including the validity of the methodology and assumptions;
○ enhance the quality, utility, and clarity of the information to be collected; and
○ 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—for example, permitting electronic submissions of responses.
III.
Comments submitted in response to this request will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Office of the Assistant Secretary for Policy, Chief Evaluation Office, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents is properly assessed. Currently, the Department of Labor is soliciting comments concerning the collection of data about the Reemployment Services and Eligibility Assessment (RESEA) Evidence Building Portfolio Project. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed below in the addressee section of this notice.
Written comments must be submitted to the office listed in the addressee section below on or before October 7, 2024.
You may submit comments by either one of the following methods:
Megan Lizik by email at
I.
This
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II.
○ evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
○ evaluate the accuracy of the agency's burden estimate of the proposed information collection, including the validity of the methodology and assumptions;
○ enhance the quality, utility, and clarity of the information to be collected; and
○ 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—for example, permitting electronic submissions of responses.
III.
Comments submitted in response to this request will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
1:00 p.m. to 1:15 p.m. (MST-AZ), Monday, August 19, 2024.
Virtual Special Board of Trustees Meeting via Microsoft Teams.
This virtual special meeting of the Board of Trustees will be open to the public. Members of the public who would like to observe this meeting may request remote access by contacting Sara Moeller at
(1) Call to Order and Chair's Remarks and (2) Program Eligibility.
Sara Moeller, Administrative Officer, 434 E University Blvd., Suite 300, Tucson, AZ 85705, (520) 901-8568.
3:00 p.m., Tuesday, August 13, 2024.
via ZOOM.
Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.
Audit Committee of the Board of Directors meeting.
The General Counsel of the Corporation has certified that in her opinion, one or more of the exemptions set forth in the Government in the Sunshine Act, 5 U.S.C. 552b(c)(2) permit closure of the following portion(s) of this meeting:
Jenna Sylvester, Paralegal, (202) 568-2560;
2:00 p.m., Thursday, August 15, 2024.
via ZOOM.
Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.
Regular Board of Directors meeting.
The General Counsel of the Corporation has certified that in her opinion, one or more of the exemptions set forth in the Government in the Sunshine Act, 5 U.S.C. 552b(c)(2) permit closure of the following portion(s) of this meeting:
Jenna Sylvester, Paralegal, (202) 568-2560;
Nuclear Regulatory Commission.
Notice; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final environmental assessment (EA) and finding of no significant impact (FONSI) for a proposed amendment of NRC Possession Only License (POL) DPR-73 for the Three Mile Island Nuclear Station, Unit No. 2 (TMI-2), located in Londonderry Township, Dauphin County, Pennsylvania. The proposed amendment would ensure that TMI-2 Energy Solutions (TMI-2
The EA and FONSI referenced in this document are available on August 8, 2024.
Please refer to Docket ID NRC-2024-0099 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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•
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Jean Trefethen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0867; email:
The Three Mile Island Nuclear Station (TMINS) is approximately 16 kilometers (10 miles) southeast of Harrisburg, Pennsylvania. The TMINS site includes Three Mile Island Nuclear Station, Unit 1 and TMI-2. It encompasses approximately 178 hectares (440 acres), including the adjacent islands on the north end, a strip of land on the mainland along the eastern shore of the river, and an area on the eastern shore of Shelley Island. The TMINS site has significance in U.S. history because it is the site of the nation's most serious commercial nuclear power plant accident, occurring at TMI-2. On March 28, 1979, TMI-2 experienced an accident initiated by interruption of secondary feedwater flow which led to a core heat up that caused fuel damage. The partial meltdown of the reactor core led to a very small offsite release of radioactivity. In response to this accident many changes occurred at nuclear power plants including emergency response planning, reactor operator training, human factors engineering, radiation protection and heightened NRC regulatory oversight.
By letter dated February 22, 2023 (ADAMS Accession No. ML23058A064), TMI-2
Pursuant to 36 CFR 800.8, the NRC used its National Environmental Policy Act process for developing the EA to facilitate consultation pursuant to section 106 of the National Historic Preservation Act (NHPA).
Adverse effects to historic properties would result from decommissioning activities at TMI-2. Therefore, the NRC and consulting parties proceeded with development of a programmatic agreement (PA) to resolve adverse effects. The draft PA was issued for public comment through a
In accordance with NRC's regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” that implement the National Environment Protection Agency (NEPA), the NRC staff has prepared an EA documenting its environmental review of the license amendment application. Based on the environmental review, the NRC has made a determination that the proposed action will not significantly affect the quality of the human environment and that a FONSI is therefore appropriate.
The EA is publicly available in ADAMS under Accession No. ML24197A005. A summary description of the proposed action and expected environmental impacts is provided as follows.
The proposed action is to amend POL No. DPR-73 so that TMI-2
In the EA, the staff assessed the potential environmental impacts from the proposed license amendment to the following resource areas: land use; visual and scenic resources; the geologic environment; surface and groundwater resources; ecological resources; air quality; noise; historic and cultural resources; socioeconomic conditions; environmental justice; public and occupational health; transportation; and waste generation and management. The NRC staff also considered the cumulative impacts from past, present, and reasonably foreseeable actions when combined with the proposed action. The TMI-2 Historic District would be adversely affected by the TMI-2 decommissioning, and adverse effects cannot be avoided. The mitigation of adverse effects to the TMI-2 Historic District will be completed in accordance with the TMI-2 Demolition and Decommissioning Programmatic Agreement (NRC 2024a).
As part of the NRC's consultation under section 7 of the Endangered Species Act, NRC staff determined that the proposed action may affect but is not likely to adversely affect the Indiana bat (
All other potential impacts from the proposed action were determined to be not significant, as described in the EA. The NRC staff found that there would be no significant negative cumulative impact to any resource area from the proposed action when added to other past, present, and reasonably foreseeable actions.
As an alternative to the proposed action, the NRC staff considered denial of the proposed action (
In accordance with the NEPA and 10 CFR part 51, the NRC staff has conducted an environmental review of a request for an amendment to POL No. DPR-73. The proposed amendment would revise the POL to allow the licensee to conduct decommissioning at TMI-2 covering activities that were not previously addressed in the staff's environmental assessments (site-specific historical and cultural resources). Based on its environmental review of the proposed action, the NRC staff has made a finding of no significant impact in the EA. Therefore, the NRC staff has determined, pursuant to 10 CFR 51.31, that preparation of an environmental impact statement is not required for the proposed action and a FONSI is appropriate.
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of intent to request extension of OMB approval, with modifications.
The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget extend its approval (with modifications), under the Paperwork Reduction Act of 1995, of the information collection related to PBGC's booklet, Qualified Domestic Relations Orders & PBGC. This notice informs the public of PBGC's intent and solicits public comment on the collection of information.
Comments must be submitted on or before October 7, 2024.
Comments may be submitted by any of the following methods:
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•
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Commenters are strongly encouraged to submit public comments electronically. Commenters who submit comments on paper by mail should allow sufficient time for mailed
All submissions received must include the agency's name (Pension Benefit Guaranty Corporation, or PBGC) and refer to OMB control number 1212-0054. All comments received will be posted without change to PBGC's website
Copies of the collection of information may be obtained without charge by writing to the Disclosure Division, Office of the General Counsel, Pension Benefit Guaranty Corporation, 445 12th Street SW, Washington, DC 20024-2101, or calling 202-229-4040 during business hours. If you are deaf or hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
Karen Levin (
A defined benefit pension plan that does not have enough money to pay benefits may be terminated if the employer responsible for the plan faces severe financial difficulty, such as bankruptcy, and is unable to maintain the plan. In such an event, PBGC becomes trustee of the plan and pays benefits, subject to legal limits, to plan participants and beneficiaries.
The benefits of a pension plan participant generally may not be assigned or alienated. Title I of ERISA provides an exception for domestic relations orders (DRO) that relate to child support, alimony payments, or marital property rights of an alternate payee (a spouse, former spouse, child, or other dependent of a plan participant). The exception applies only if the DRO meets specific legal requirements that make it a qualified domestic relations order (QDRO).
When PBGC is trustee of a plan, it reviews submitted domestic relations orders to determine whether the order is qualified before paying benefits to an alternate payee. The requirements for submitting a domestic relations order and the contents of such orders are established by statute. The models and the guidance provided by PBGC assist parties by making it easier for them to comply with ERISA's QDRO requirements in plans trusteed by PBGC; they do not create any additional requirements and result in a reduction of the statutory burden.
The Office of Management and Budget (OMB) has approved the collection of information in PBGC's booklet,
PBGC is adding one term and is making clarifying changes to other terms in the Glossary. PBGC is making other editorial and clarifying changes to the QDRO booklet.
PBGC estimates that it will receive approximately 253 DROs each year. PBGC further estimates that the total average annual burden of this collection of information will be approximately 190 hours and $177,100.
PBGC is soliciting public comments to—
• evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodologies and assumptions used;
• enhance the quality, utility, and clarity of the information to be collected; and
• 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,
Issued in Washington, DC.
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.
2.
3.
4.
5.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 31, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 1, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 30, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 30, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 5, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 1, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 30, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 31, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 2, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 31, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 1, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 2, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 31, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 29, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 2, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 30, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 30, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 2, 2024, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Sean C. Robinson, 202-268-8405.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on August 2, 2024, it filed with the Postal Regulatory Commission a
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's fee for Remote Hands Services, as described further below.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on August 19, 2024.
The text of the proposed rule change is available on the Exchange's website at
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 purpose of the proposed rule change is to amend a service fee relating to connectivity and co-location services. Specifically, the Exchange proposes to decrease its fee for Remote Hands Services, at General 8, section 1, to $151.50 per hour.
General 8, section 1 includes the Exchange's fees that relate to co-location services, including “Remote Hands Services.” The term “Remote Hands Services” refers to the use of Exchange engineers to perform on-site technical support tasks in its Data Center on behalf of its co-located customers, including the following: (1) power cycling of equipment; (2) patching and plugging in cabling and circuits; (3) observing, describing or reporting on display indicators; (4) configuration of hardware components instructed by the customer; (5) diagnosis and repairs as instructed by the customer; (6) swapping hardware components with customer-supplied spares or upgrades; (7) troubleshooting heat related issues as instructed by the Customer; and (8) returning defective equipment to the manufacturer or customer.
Earlier this year, the Exchange increased its $150 per hour fee for Remote Hands Services, along with other connectivity and co-location services, by 5.5%, to partially account for the cumulative effects of inflation on the value to the Exchange of the revenues it earns through such fees.
The purpose of the proposed change in the Exchange's Remote Hands Services fee is the same as that which the Exchange expressed when it increased the fee by 5.5% earlier this year. That is, the change would enable the Exchange to maintain and improve its market technology and services. Prior to SR-Phlx-2024-27, the Exchange had not increased its Remote Hands fee since 2010.
The proposed fee represents a decrease in the existing $158 per hour rate, and a net overall 1% increase from the original $150 per month fee. The 1% fee increase, resulting in a proposed amended rate of $151.50 per hour, is far below the rates of inflation, as measured by either the CPI, the PPI, or the AHE since 2010. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2010. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. The Exchange notes that other exchanges have filed for comparable or higher increases in certain connectivity-related fees, based in part on similar rationale.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. These investments, and the value they provide to customers, far exceed the amount of the proposed net price increase over the prior $150 per hour rate. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
This belief is based on a couple factors. First, the current fee does not properly reflect the value of the service, as fees for the service in question has been static in nominal terms, and therefore falling in real terms due to inflation. Second, exchange fees are constrained by the fact that market participants can choose among 16 different venues for equities trading and 17 different venues for options trading, and therefore no single venue can charge excessive fees for its products without losing customers and market share.
As explained above, prior to SR-Phlx-2024-27, the Exchange had not increased its Remote Hands Service fee since it introduced the fee in 2010. This means that this fee has fallen in real terms due to inflation, which has been notable. Between 2010 and 2024, the dollar had an average inflation rate of 2.64% per year, producing a cumulative price increase of 44.03%.
The proposed fee represents a decrease from the existing $158 per hour fee and a 1% overall net increase from the original $150 per hour fee, which is far below the rates of inflation, as measured by either the CPI, the PPI, or AHE since 2010. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2010. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. Again, these investments, and the value they provide to customers, far exceed the amount of the proposed price increase. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
Customers face many choices in where to trade both equities and options. Market participants will continue to choose trading venues and the method of connectivity based on their specific needs. No broker-dealer is required to become a Member of the Exchange. There is no regulatory requirement that any market participant connect to any one exchange, nor that any market participant connect at a particular connection speed or act in a particular capacity on the Exchange, or trade any particular product offered on an exchange. Moreover, membership is not a requirement to participate on the Exchange. Indeed, the Exchange is unaware of any one exchange whose membership includes every registered broker-dealer. The Exchange also believes substitutable products and services are available to market participants, including, among other
There are currently 16 registered equities exchanges that trade equities and 17 exchanges offering options trading services. No single equities exchange has more than 15% of the market share.
As such, the Exchange must set its fees, including its fees for Remote Hands Services, competitively. If not, customers may move to other venues or reduce use of the Exchange's services. “If competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.”
In summary, the proposal represents an equitable allocation of reasonable dues, fees and other charges because Exchange fees have fallen in real terms and customers have a choice in trading venue and will exercise that choice and trade at another venue if exchange fees are not set competitively.
The Exchange believes that the proposed fee change is not unfairly discriminatory because the fee is assessed uniformly across all market participants that voluntarily purchase Remote Hands Services, which are available to all customers.
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 burdens inter-market competition (the competition among self-regulatory organizations) because approval of the proposal does not impose any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which market participants can determine whether or not to connect to the Exchange based on the value received compared to the cost of doing so. Indeed, market participants have numerous alternative exchanges that they may participate on and direct their order flow, as well as off-exchange venues, where competitive products are available for trading.
Nothing in the proposal burdens intra-market competition (the competition among consumers) because the Exchange's Remote Hands Services are available to any customer under the same fee schedule as any other customer, and any market participant that wishes to purchase such services can do so on a non-discriminatory basis.
No written comments were either solicited or received.
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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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)
The Exchange proposes to amend its Price List to (1) revise the requirements for market at-the-close (“MOC”) and limit at the close (“LOC”) orders on MOC/LOC Tier 1 and Tier 2; (2) modify the requirements and charges for D Orders at the close based on time of entry or last modification; and (3) introduce incremental per share credits for orders entered and executed by a Floor broker that add liquidity to the Exchange and for D Orders at the close. The Exchange proposes to implement the fee changes effective July 26, 2024. 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 its Price List to (1) revise the requirements for MOC and LOC orders on MOC/LOC Tier 1 and Tier 2; (2) modify the requirements and charges for D Orders at the close based on time of entry or last modification; and (3) introduce incremental per share credits for orders entered and executed by a Floor broker that add liquidity to the Exchange and for D Orders at the close.
The proposed change responds to the current competitive environment where order flow providers have a choice of where to direct liquidity-providing orders and closing price orders by revising the requirements and offering additional incentives for member organizations to send liquidity to the Exchange, especially during the Closing Auction. The purpose of the proposed rule change is also to encourage efficient usage of Exchange systems by member organizations by continuing to encourage all member organizations to enter or modify D Orders as early possible, which the Exchange believes is in the best interests of all member organizations and investors who access the Exchange.
The Exchange proposes to implement the fee changes effective July 26, 2024.
The Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
While Regulation NMS has enhanced competition, it has also fostered a “fragmented” market structure where trading in a single stock can occur across multiple trading centers. When multiple trading centers compete for order flow in the same stock, the Commission has recognized that “such competition can lead to the fragmentation of order flow in that stock.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can move order flow, or discontinue or reduce use of certain categories of products. While it is not possible to know a firm's reason for shifting order flow, the Exchange believes that one such reason is because of fee changes at any of the registered exchanges or non-exchange venues to which the firm routes order flow. Accordingly, competitive forces compel the Exchange to use exchange transaction fees and credits because market participants can readily trade on competing venues if they deem pricing levels at those other venues to be more favorable.
In response to this competitive environment, the Exchange has established incentives for member organizations who submit orders on the Exchange. The proposed fee change is designed to provide incentives to member organizations to submit additional such liquidity to the Exchange, including during closing auctions.
Currently, for MOC/LOC Tier 1, the Exchange charges $0.0007 per share for MOC orders and $0.0007 per share for LOC orders from any member organization in the prior three billing months executing (1) an average daily trading volume (“ADV”) of MOC activity on the NYSE of at least 0.45% of NYSE consolidated ADV (“CADV”),
The Exchange proposes to eliminate the third requirement from both tiers.
As proposed for MOC/LOC Tier 1, the Exchange would charge $0.0007 per share for MOC orders and $0.0007 per share for LOC orders from any member organization in the prior three billing months executing an (1) ADV of MOC activity on the NYSE of at least 0.45% of NYSE CADV), and (2) ADV of total close activity (MOC/LOC and executions at the close) on the NYSE of at least 0.7% of NYSE CADV. The current rates would remain the same.
As proposed for MOC/LOC Tier 2, the Exchange would charge $0.0008 per share for MOC orders and $0.0008 per share for LOC orders from any member organization in the prior three billing months executing an (1) an ADV of MOC activity on the NYSE of at least 0.35% of NYSE CADV, and (2) an ADV of total close activity (MOC/LOC and executions at the close) on the NYSE of at least 0.525% of NYSE CADV. The current rates would also remain the same.
The proposed change responds to the current competitive environment where order flow providers have a choice of where to direct orders in NYSE-listed securities, including at the close, by modifying requirements in order to facilitate member organizations qualifying for a MOC/LOC tier and encourage additional liquidity to the Exchange. Higher volumes of MOC and LOC orders contribute to the quality of the Exchange's closing auction and provide market participants whose orders are executed at the close with a greater opportunity for execution, which benefits all market participants.
Currently, the Exchange does not charge member organizations for the first 750,000 ADV of the aggregate of executions at the close for D Orders, Floor broker executions swept into the close, and executions at the close, excluding MOC Orders, LOC Orders and Closing Offset (“CO”) Orders. Further, the Exchange currently charges certain fees differentiated by time of entry (or last modification) for D Orders at the close after the first 750,000 ADV of aggregate of executions at the close by a member organization.
The Exchange proposes to no longer exclude the first 750,000 ADV of the aggregate of executions at the close by member organizations for D Orders, Floor broker executions swept into the close, and executions at the close, excluding MOC Orders, LOC Orders and CO Orders. As discussed below, the Exchange would waive fees for member organizations with an ADV of at least 10,000 shares entered and executed by its Floor broker up to specific monthly ADV levels based on time of entry (or last modification) in an effort to encourage additional liquidity on the trading floor of a national securities exchange.
The Exchange also proposes to modify the time of entry (or last modification) for D Order fee determination in order to encourage member organizations to enter D Orders earlier in the trading day, thereby increasing transparency in the Closing Auction and reducing member organization's operational risk. Consistent with this purpose, the current rates for D Orders would not change with the exception of D Orders entered in the final minute of trading, which the Exchange proposes to label as “Late D Orders.”
The Exchange would modify the current requirements and charges for D Orders as follows:
• The Exchange currently charges $0.0003 per share for executed D Orders last modified
• The Exchange currently charges $0.0007 per share for executed D Orders last modified by the member organization from 25 minutes up to but not including 3 minutes before the scheduled close of trading. The Exchange proposes to charge the current rate to D Orders last modified from 10 minutes up to but not including 1 minute before the scheduled close of trading. The Exchange would define these orders as “Mid D Orders.”
• For D Orders last modified in the last 3 minutes before the scheduled
○ The Exchange currently charges $0.0008 per share for executed D Orders last modified in the last 3 minutes before the scheduled close of trading for member organizations in MOC/LOC Tiers 1 and 2, both with Adding ADV of at least 0.50% of Tape A CADV or MOC/LOC Tiers 1, 2 or 3 with Adding ADV of at least 1.05% of Tape A CADV. The Exchange would eliminate the limitation to member organizations in MOC/LOC Tiers 1 and 2 and would charge $0.0011 per share for executed D Orders last modified in the last 1 minute before the scheduled close of trading for member organizations with Adding ADV of at least 0.50% of Tape A CADV (unchanged from the current requirement) and total close activity of a least 1.75% of Tape A CADV.
○ The Exchange currently charges $0.0009 per share for executed D Orders last modified in the last 3 minutes before the scheduled close of trading for member organizations in MOC/LOC Tiers 1, 2 and 3 with Adding ADV of at least 0.65% of Tape A CADV. The Exchange would eliminate this fee.
○ The Exchange currently charges $0.0010 per share for executed D Orders last modified in the last 3 minutes before the scheduled close of trading for all other member organizations. The Exchange proposes to charge all other member organizations $0.0012 per share for executed D Orders last modified one minute before the scheduled close of trading.
• For member organizations with an ADV of at least 10,000 shares entered and executed by its Floor broker, the Exchange proposes that Early, Mid- and Late D Orders up to specific monthly ADV levels would be free.
As proposed, qualifying member organizations would not be charged for the first 500,000 shares of Early D Orders, with the above rates for Early D Orders applicable to all volume above that threshold.
For Mid D Orders, qualifying member organizations would not be charged for the first 750,000 shares, with the above rates for Mid D Orders applicable to all volume above that threshold.
Finally, for Late D Orders, qualifying member organizations would not be charged for the first 250,000 shares, with the above rates for Late D Orders applicable to all volume above that threshold.
• Orders from continuous trading swept into the close would continue to be charged the current rate of $0.0008.
The purpose of these changes is to continue to encourage additional liquidity on the Exchange. The Exchange does not know how much order flow member organizations choose to route to other exchanges or to off-exchange venues. Since the proposal not to charge Early, Mid- and Late D Orders up to specific monthly ADV levels for member organizations with a minimum ADV entered and executed by its Floor broker would be new, the Exchange does not know how many member organizations could qualify based on their current trading profile and if they choose to direct order flow to the Exchange. Based on the profile of member organizations and their liquidity provision, the Exchange believes that additional member organizations could qualify for the discounts if they choose to direct order flow to the Exchange. However, without having a view of member organization's activity on other exchanges and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would result in any member organization directing orders to the Exchange in order to qualify for the discounts.
The Exchange believes that it is reasonable to not charge member organizations for Early, Mid- and Late D Orders up to specific monthly ADV levels if the member organization has an ADV of at least 10,000 shares executed by its Floor broker. The Exchange notes that other marketplaces offer various incentives to only certain members based on ADV and/or heightened quoting requirements. For instance, marketplaces offer incremental credits to members that are lead market makers (“LMM”) registered in a minimum number of securities and that add a specified percentage of displayed liquidity
As part of what the Exchange proposes to call the “Floor Broker Incentive and Rebate Program,” the Exchange proposes an incremental per share credit for orders executed by a Floor broker in addition to the preceding fees and credits specified in the Price List. Specifically, the Exchange proposes that orders executed by a member organization's Floor broker would receive an additional $0.0002 per share for orders that add liquidity to the Exchange, other than MPL and Non-Displayed Limit Orders, and/or (2) an additional $0.000025 per share for the proposed Early, Mid-and Late D Orders where the member organization has (1) an ADV of at least 10,000 shares entered and executed by its Floor broker, and (2) an ADV comprised of at least 50% Floor broker ADV of the member organization's total ADV, excluding routing.
For example, assume that Member Organization A enters and executes 2 million shares that add liquidity on the trading Floor though its Floor broker. Further assume that a second member
The purpose of the proposed incremental Floor broker credits is to continue to encourage member organizations to send orders to trading Floor for execution, thereby contributing to robust levels of liquidity, especially for adding liquidity and during the Closing Auction, which benefits all market participants. Members and member organizations benefit from the substantial amounts of liquidity present on the Exchange during the close. The Exchange believes the proposed change would also thereby promote price discovery and transparency, and enhance order execution opportunities for member organizations from the substantial amounts of liquidity that are present on the Exchange both intraday and during the close.
Since the proposed incremental credits are new, the Exchange does not know how many member organizations could qualify for the new discounts based on their current trading profile and if they choose to direct order flow to the Exchange. Based on the profile of liquidity-adding firms generally, the Exchange believes that a number of member organizations could qualify for the credits if they choose to direct order flow to the Exchange. However, without having a view of member organization's activity on other exchanges and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would result in any member organization directing orders to the Exchange in order to qualify for the discounts.
The proposed changes are not otherwise intended to address other issues, and the Exchange is not aware of any significant problems that market participants would have in complying with the proposed changes.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
As discussed above, the Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
In light of the competitive environment in which the Exchange currently operates, the proposed rule change is a reasonable attempt to increase liquidity to the Exchange, especially during the Closing Auction, and improve the Exchange's market share relative to its competitors. The Exchange believes the proposed change is also reasonable because it is designed to attract higher volumes of orders transacted on the Exchange by member organizations, which would benefit all market participants by offering greater price discovery and an increased opportunities to trade on the Exchange, both intraday and during the Closing Auction. The proposed rule change also represents a reasonable attempt to encourage efficient usage of Exchange systems by member organizations by continuing to encourage all member organizations to enter or modify D Orders as early possible, which the Exchange believes is in the best interests of all member organizations and investors who access the Exchange.
The Exchange believes that eliminating the requirement that a member organization's MOC activity comprise at least 35% of the member organization's total close activity (MOC/LOC and other executions at the close) in order to qualify for to qualify for MOC/LOC Tier 1 and Tier 2 is a reasonable way to encourage greater participation which leads to greater marketable and other liquidity at the Closing Auction. MOC and LOC orders contribute meaningfully to the price and size discovery, which is the hallmark of the closing auction process. Higher volumes of MOC orders contribute to the quality of the Exchange's Closing Auction and provide market participants whose orders are executed at the close with a greater opportunity for execution, which benefits all market participants. Further, as noted above, in the currently highly competitive national market system, competition for closing orders among exchanges, ATSs and other market execution venues is robust.
The Exchange believes that it proposal would encourage additional liquidity on the Exchange from multiple sources, which helps to maintain the quality of the Exchange's Closing Auction for the benefit of all market participants.
Specifically, the Exchange believes that no longer exempting the first 750,000 ADV of the aggregate of executions at the close from fees is reasonable as it has not operated as originally intended. Member organizations that currently reach the 750,000 ADV threshold are generally larger member organizations that would continue to derive a substantial benefit from the high volume of closing executions on the Exchange and the Exchange believes would continue to send orders to send orders to the Exchange. While the Exchange is removing the first 750,000 ADV exemption, it notes that it is introducing a new exemption for qualifying member organizations with a Floor broker, which totals 1.5 million shares across Early-, Mid- and Late D Orders. Further, the Exchange believes that not charging Early, Mid- and Late D Orders up to specific monthly ADV levels for member organizations with a minimum
Similarly, the Exchange believes that modifying the time of entry for last modification for member organizations to qualify for the existing fees for Early, Mid- and Late D Orders encourages all member organizations to enter or modify D Orders as early possible, beginning with as early as up to 10 minutes before the close of trading, in order to build up liquidity going into the Closing Auction. Member organizations are waiting until later in the trading day to enter and/or modify D Orders than the current 25 minutes. By expanding the time period to enter Early D Orders to up to 10 minutes before the close, the Exchange hopes to encourage member organizations to send D Orders earlier in order to qualify for lower fees. Moreover, the Exchange hopes thereby to incentivize more member organizations to send adding liquidity to the Exchange, which in turn supports the quality of price discovery on the Exchange. In addition, charging member organizations higher rates for entering or modifying their interest in the final minute of regular trading hours reflects a risk premium for delaying entry or modification until nearly the end of trading, while reducing the time entry which results in fewer trades qualifying for these higher fees. Further, it is reasonable to charge member organizations a lower rate based on a higher percentage of Adding ADV of Tape A CADV and total close activity of Tape A CADV for entering or modifying their interest in the final minute of regular trading hours because such interest most benefits from the flexibility afforded the order type. The Exchange notes that while the proposed fee for Late D-Orders is higher than the current fee, the proposed increase in time of order entry or last modified to qualify for Early- and Mid D Orders, which have lower rates than Late D Orders, will result in lower overall fees for member organizations, and incentivize greater liquidity in the Closing Auction, which benefits all market participants.
The Exchange believes that the proposed additional credits for orders executed by a Floor broker for representation on the Exchange is a reasonable way to encourage additional liquidity, including D Orders, on the Exchange both during intraday and in Closing Auction because member organizations benefit from the substantial amounts of liquidity that are present on the Exchange during such times. The Exchange believes the proposed change would encourage member organizations to send orders to the trading Floor for execution, thereby contributing to robust levels of liquidity on the trading Floor both intraday and during the Closing Auction, which benefits all market participants. The proposed fee would also encourage the submission of additional liquidity to a national securities exchange, thereby promoting price discovery and transparency and enhancing order execution opportunities for member organizations from the substantial amounts of liquidity that are present on the Exchange during the closing. The proposed change would also encourage the execution of such transactions on a public exchange, thereby promoting price discovery and transparency. Moreover, the Exchange believes that requiring an ADV comprised of at least 50% Floor broker ADV of the member organization's total ADV is reasonable because it would encourage member organizations that make a substantial contribution to trading Floor liquidity without excluding smaller member organizations.
The Exchange believes the proposal equitably allocates fees and credits among market participants because all member organizations that participate on the Exchange may qualify for the proposed credits and fees on an equal basis. The Exchange believes its proposal equitably allocates its fees and credits among its market participants by fostering liquidity provision and stability in the marketplace.
The Exchange believes that the proposed elimination of the requirement that a member organization's MOC activity comprise at least 35% of the member organization's total close activity (MOC/LOC and other executions at the close) in order to qualify for to qualify for MOC/LOC Tier 1 and Tier 2 will incentivize member organizations to send additional liquidity to achieve lower fees and encourage greater marketable and other liquidity at the closing auction. Higher volumes of MOC and LOC orders contribute to the quality of the Exchange's Closing Auction and provide market participants whose orders are executed in the close with a greater opportunity for execution of orders on the Exchange, thereby promoting price discovery and transparency and enhancing order execution opportunities and improving overall liquidity on a public exchange. The Exchange also believes that the proposed change is equitable because it would apply to all similarly situated member organizations that utilize MOC and LOC orders on the Exchange on an equal basis.
The Exchange believes that the proposed changes to D Orders are an equitable allocation of fees because the proposed changes, taken together, will incentivize member organizations to enter or modify D Orders as early possible, beginning with as early as up to 10 minutes before the close of trading, in order to build up liquidity going into the closing auction. The Exchange's closing auction is a recognized industry benchmark,
The proposed incremental credits for orders executed by a member organization's Floor broker that add liquidity to the Exchange and D Orders during the close, are equitable because the incremental fees would be available on an equal basis to all similarly situated member organizations that operate a Floor brokerage business. In this regard, the proposed discounts and requirements are equitable because any member organization can choose to increase their adding volume entered and executed by its Floor broker, excluding routing, in order to qualify for the proposed incremental credits and any member organization can choose to operate as a Floor broker in order to qualify for the additional credits on an equal basis. The Exchanges notes that the current Incremental Discounts on MOC Orders utilize similar requirements.
The Exchange believes that the proposal is not unfairly discriminatory. In the prevailing competitive environment, member organizations are free to disfavor the Exchange's pricing if they believe that alternatives offer them better value.
The proposed streamlined requirements for MOC orders to qualify for MOC/LOC Tiers 1 and 2 are not unfairly discriminatory because the requirements would be applied to all similarly situated member organizations and other market participants, who would all be subject to the same fees, requirements and discounts on a full and equal basis. For the same reason, the proposal neither targets nor will it have a disparate impact on any particular category of market participant. Accordingly, no member organization already operating on the Exchange would be disadvantaged by this allocation of fees. Finally, the submission of orders to the Exchange is optional for member organizations in that they could choose whether to submit orders to the Exchange and, if they do, the extent of its activity in this regard.
The Exchange believes that the proposed changes to D Orders to modify the time periods by which such orders are considered early, mid-or late is not unfairly discriminatory because the proposed changes will incentivize member organizations to enter or modify D Orders as early as possible, beginning with as early as up to 10 minutes before the close of trading, in order to build up liquidity going into the closing auction. The Exchange also believes that it is not unfairly discriminatory to charge member organizations a higher rate for entering or modifying their interest in the final minute of regular trading hours because all member organizations can utilize D Orders and all have an equal choice as to when to submit those orders to benefit most from the flexibility afforded the order type. The Exchange believes that the proposal is not unfairly discriminatory because all similarly situated member organizations that submit D Orders last modified in the last 10 minutes and less before the scheduled close of trading will be subject to the same fee structure based on time of entry (or last modification). In addition, the Exchange believes that waiving fees for Early, Mid- and Late D Orders for member organizations with a Floor broker plus an adding volume requirement is equitable because the proposed fee waiver would apply equally to all similarly situated member organizations. Moreover, the proposed fee waiver is not unfairly discriminatory because member organizations that do not operate a Floor brokerage business can still qualify for the fee waiver by choosing to add a Floor broker on the Exchange. Indeed, to the extent that member organizations add Floor brokers to qualify for the proposed fee waiver for D Orders, the proposal would have the added benefit of potentially attracting new Floor brokers to the Exchange. In addition, the Exchange believes that it is reasonable to not charge member organizations for Early, Mid- and Late D Orders up to specific monthly ADV levels if the member organization has an ADV of at least 10,000 shares executed by a Floor broker. As noted, other marketplaces offer various incentives to only certain members based on ADV and/or heightened quoting requirements.
The proposed incremental Floor broker credits are not unfairly discriminatory because the proposed fees would be applied to all similarly situated member organizations and other market participants operating a Floor brokerage business, who would all be subject to the same fees, requirements, and discounts on an equal basis. For the same reason, the proposal neither targets nor will it have a disparate impact on any particular category of market participant. Accordingly, no member organization already operating on the Exchange would be disadvantaged by this allocation of fees. Further, the Exchange believes the proposal would incentivize member organizations to send more orders to the Floor in order to qualify for incremental credits. Finally, the submission of orders to the Exchange is optional for member organizations in that they could choose whether to submit orders to the Exchange and, if they do, the extent of its activity in this regard.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change has become effective upon filing pursuant to Section 19(b)(3)(A)
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 the Exchange's fee for Remote Hands Services, as described further below.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on August 19, 2024.
The text of the proposed rule change is available on the Exchange's website at
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
The purpose of the proposed rule change is to amend a service fee relating to connectivity and co-location services. Specifically, the Exchange proposes to decrease its fee for Remote Hands Services, at General 8, section 1, to $151.50 per hour.
General 8, section 1 includes the Exchange's fees that relate to co-location services, including “Remote Hands Services.” The term “Remote Hands Services” refers to the use of Nasdaq engineers to perform on-site technical support tasks in its Data Center on behalf of its co-located customers, including the following: (1) power cycling of equipment; (2) patching and plugging in cabling and circuits; (3) observing, describing or reporting on display indicators; (4) configuration of hardware components instructed by the customer; (5) diagnosis and repairs as instructed by the customer; (6) swapping hardware components with customer-supplied spares or upgrades; (7) troubleshooting heat related issues as instructed by the Customer; and (8) returning defective equipment to the manufacturer or customer.
Earlier this year, the Exchange increased its $150 per hour fee for Remote Hands Services, along with other connectivity and co-location services, by 5.5%, to partially account for the cumulative effects of inflation on the value to Nasdaq of the revenues it earns through such fees.
The purpose of the proposed change in the Exchange's Remote Hands Services fee is the same as that which the Exchange expressed when it increased the fee by 5.5% earlier this year. That is, the change would enable the Exchange to maintain and improve its market technology and services. Prior to SR-NASDAQ-2024-032, the Exchange had not increased its Remote Hands fee since 2010.
The proposed fee represents a decrease in the existing $158 per hour rate, and a net overall 1% increase from the original $150 per month fee. The 1% fee increase, resulting in a proposed amended rate of $151.50 per hour, is far below the rates of inflation, as measured by either the CPI, the PPI, or the AHE since 2010. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2010. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. The Exchange notes that other exchanges have filed for comparable or higher increases in certain connectivity-related fees, based in part on similar rationale.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding Nasdaq's existing co-location facility to offer customers additional space and power. These investments, and the value they provide to customers, far exceed the amount of the proposed net price increase over the prior $150 per hour rate. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
This belief is based on a couple factors. First, the current fee does not properly reflect the value of the service, as fees for the service in question has been static in nominal terms, and
As explained above, prior to SR-NASDAQ-2024-032, the Exchange had not increased its Remote Hands Service fee since it introduced the fee in 2010. This means that this fee has fallen in real terms due to inflation, which has been notable. Between 2010 and 2024, the dollar had an average inflation rate of 2.64% per year, producing a cumulative price increase of 44.03%.
The proposed fee represents a decrease from the existing $158 per hour fee and a 1% overall net increase from the original $150 per hour fee, which is far below the rates of inflation, as measured by either the CPI, the PPI, or AHE since 2010. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2010. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding Nasdaq's existing co-location facility to offer customers additional space and power. Again, these investments, and the value they provide to customers, far exceed the amount of the proposed price increase. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
Customers face many choices in where to trade both equities and options. Market participants will continue to choose trading venues and the method of connectivity based on their specific needs. No broker-dealer is required to become a Member of the Exchange. There is no regulatory requirement that any market participant connect to any one exchange, nor that any market participant connect at a particular connection speed or act in a particular capacity on the Exchange, or trade any particular product offered on an exchange. Moreover, membership is not a requirement to participate on the Exchange. Indeed, the Exchange is unaware of any one exchange whose membership includes every registered broker-dealer. The Exchange also believes substitutable products and services are available to market participants, including, among other things, other equities and options exchanges that a market participant may connect to in lieu of the Exchange, indirect connectivity to the Exchange via a third-party reseller of connectivity, and/or trading of equities or options products within markets which do not require connectivity to the Exchange, such as the Over-the-Counter markets.
There are currently 16 registered equities exchanges that trade equities and 17 exchanges offering options trading services. No single equities exchange has more than 15% of the market share.
As such, the Exchange must set its fees, including its fees for Remote Hands Services, competitively. If not, customers may move to other venues or reduce use of the Exchange's services. “If competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.”
In summary, the proposal represents an equitable allocation of reasonable dues, fees and other charges because Exchange fees have fallen in real terms
The Exchange believes that the proposed fee change is not unfairly discriminatory because the fee is assessed uniformly across all market participants that voluntarily purchase Remote Hands Services, which are available to all customers.
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 burdens inter-market competition (the competition among self-regulatory organizations) because approval of the proposal does not impose any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which market participants can determine whether or not to connect to the Exchange based on the value received compared to the cost of doing so. Indeed, market participants have numerous alternative exchanges that they may participate on and direct their order flow, as well as off-exchange venues, where competitive products are available for trading.
Nothing in the proposal burdens intra-market competition (the competition among consumers) because the Exchange's Remote Hands Services are available to any customer under the same fee schedule as any other customer, and any market participant that wishes to purchase such services can do so on a non-discriminatory basis.
No written comments were either solicited or received.
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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 the Exchange's fee for Remote Hands Services, as described further below.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on August 19, 2024.
The text of the proposed rule change is available on the Exchange's website at
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
The purpose of the proposed rule change is to amend a service fee relating to connectivity and co-location services. Specifically, the Exchange proposes to decrease its fee for Remote Hands Services, at General 8, Section 1, to $151.50 per hour.
General 8, Section 1 includes the Exchange's fees that relate to co-location services, including “Remote Hands Services.” The term “Remote Hands Services” refers to the use of Exchange engineers to perform on-site technical support tasks in its Data Center on behalf of its co-located customers, including the following: (1) power cycling of equipment; (2) patching and plugging in cabling and circuits; (3) observing, describing or reporting on display indicators; (4) configuration of hardware components instructed by the customer; (5) diagnosis and repairs as instructed by the customer; (6) swapping hardware components with customer-supplied spares or upgrades; (7) troubleshooting heat related issues as instructed by the Customer; and (8) returning defective equipment to the manufacturer or customer.
Earlier this year, the Exchange increased its $150 per hour fee for Remote Hands Services, along with other connectivity and co-location services, by 5.5%, to partially account for the cumulative effects of inflation on the value to the Exchange of the revenues it earns through such fees.
The purpose of the proposed change in the Exchange's Remote Hands Services fee is the same as that which the Exchange expressed when it increased the fee by 5.5% earlier this year. That is, the change would enable the Exchange to maintain and improve its market technology and services. Prior to SR-BX-2024-020, the Exchange had not increased its Remote Hands fee since 2010.
The proposed fee represents a decrease in the existing $158 per hour rate, and a net overall 1% increase from the original $150 per month fee. The 1% fee increase, resulting in a proposed amended rate of $151.50 per hour, is far below the rates of inflation, as measured by either the CPI, the PPI, or the AHE since 2010. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2010. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. The Exchange notes that other exchanges have filed for comparable or higher increases in certain connectivity-related fees, based in part on similar rationale.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. These investments, and the value they provide to customers, far exceed the amount of the proposed net price increase over the prior $150 per hour rate. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
This belief is based on a couple factors. First, the current fee does not properly reflect the value of the service,
As explained above, prior to SR-BX-2024-020, the Exchange had not increased its Remote Hands Service fee since it introduced the fee in 2010. This means that this fee has fallen in real terms due to inflation, which has been notable. Between 2010 and 2024, the dollar had an average inflation rate of 2.64% per year, producing a cumulative price increase of 44.03%.
The proposed fee represents a decrease from the existing $158 per hour fee and a 1% overall net increase from the original $150 per hour fee, which is far below the rates of inflation, as measured by either the CPI, the PPI, or AHE since 2010. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2010. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. Again, these investments, and the value they provide to customers, far exceed the amount of the proposed price increase. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
Customers face many choices in where to trade both equities and options. Market participants will continue to choose trading venues and the method of connectivity based on their specific needs. No broker-dealer is required to become a Member of the Exchange. There is no regulatory requirement that any market participant connect to any one exchange, nor that any market participant connect at a particular connection speed or act in a particular capacity on the Exchange, or trade any particular product offered on an exchange. Moreover, membership is not a requirement to participate on the Exchange. Indeed, the Exchange is unaware of any one exchange whose membership includes every registered broker-dealer. The Exchange also believes substitutable products and services are available to market participants, including, among other things, other equities and options exchanges that a market participant may connect to in lieu of the Exchange, indirect connectivity to the Exchange via a third-party reseller of connectivity, and/or trading of equities or options products within markets which do not require connectivity to the Exchange, such as the Over-the-Counter markets.
There are currently 16 registered equities exchanges that trade equities and 17 exchanges offering options trading services. No single equities exchange has more than 15% of the market share.
As such, the Exchange must set its fees, including its fees for Remote Hands Services, competitively. If not, customers may move to other venues or reduce use of the Exchange's services. “If competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.”
In summary, the proposal represents an equitable allocation of reasonable
The Exchange believes that the proposed fee change is not unfairly discriminatory because the fee is assessed uniformly across all market participants that voluntarily purchase Remote Hands Services, which are available to all customers.
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 burdens inter-market competition (the competition among self-regulatory organizations) because approval of the proposal does not impose any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which market participants can determine whether or not to connect to the Exchange based on the value received compared to the cost of doing so. Indeed, market participants have numerous alternative exchanges that they may participate on and direct their order flow, as well as off-exchange venues, where competitive products are available for trading.
Nothing in the proposal burdens intra-market competition (the competition among consumers) because the Exchange's Remote Hands Services are available to any customer under the same fee schedule as any other customer, and any market participant that wishes to purchase such services can do so on a non-discriminatory basis.
No written comments were either solicited or received.
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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 the Exchange's fee for Remote Hands Services, as described further below.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on August 19, 2024.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for
The purpose of the proposed rule change is to amend a service fee relating to connectivity and co-location services. Specifically, the Exchange proposes to decrease its fee for Remote Hands Services, at General 8, section 1, to $151.50 per hour.
General 8, section 1 includes the Exchange's fees that relate to co-location services, including “Remote Hands Services.” The term “Remote Hands Services” refers to the use of Exchange engineers to perform on-site technical support tasks in its Data Center on behalf of its co-located customers, including the following: (1) power cycling of equipment; (2) patching and plugging in cabling and circuits; (3) observing, describing or reporting on display indicators; (4) configuration of hardware components instructed by the customer; (5) diagnosis and repairs as instructed by the customer; (6) swapping hardware components with customer-supplied spares or upgrades; (7) troubleshooting heat related issues as instructed by the Customer; and (8) returning defective equipment to the manufacturer or customer.
Earlier this year, the Exchange increased its $150 per hour fee for Remote Hands Services, along with other connectivity and co-location services, by 5.5%, to partially account for the cumulative effects of inflation on the value to the Exchange of the revenues it earns through such fees.
The purpose of the proposed change in the Exchange's Remote Hands Services fee is the same as that which the Exchange expressed when it increased the fee by 5.5% earlier this year. That is, the change would enable the Exchange to maintain and improve its market technology and services. Prior to SR-GEMX-2024-15, the Exchange had not increased its Remote Hands fee since 2017.
The proposed fee represents a decrease in the existing $158 per hour rate, and a net overall 1% increase from the original $150 per month fee. The 1% fee increase, resulting in a proposed amended rate of $151.50 per hour, is far below the rates of inflation, as measured by either the CPI, the PPI, or the AHE since 2017. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2017. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. The Exchange notes that other exchanges have filed for comparable or higher increases in certain connectivity-related fees, based in part on similar rationale.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. These investments, and the value they provide to customers, far exceed the amount of the proposed net price increase over the prior $150 per hour rate. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
This belief is based on a couple factors. First, the current fee does not properly reflect the value of the service, as fees for the service in question has been static in nominal terms, and therefore falling in real terms due to inflation. Second, exchange fees are constrained by the fact that market participants can choose among 17 different venues for options trading, and therefore no single venue can charge excessive fees for its products without losing customers and market share.
As explained above, prior to SR-GEMX-2024-15, the Exchange had not increased its Remote Hands Service fee since it introduced the fee in 2017. This means that this fee has fallen in real terms due to inflation, which has been notable. Between 2017 and 2024, the dollar had an average inflation rate of 3.34% per year, producing a cumulative price increase of 25.82%.
The proposed fee represents a decrease from the existing $158 per hour fee and a 1% overall net increase from the original $150 per hour fee, which is far below the rates of inflation, as measured by either the CPI, the PPI, or AHE since 2017. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2017. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. Again, these investments, and the value they provide to customers, far exceed the amount of the proposed price increase. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
Customers face many choices in where to trade options. Market participants will continue to choose trading venues and the method of connectivity based on their specific needs. No broker-dealer is required to become a Member of the Exchange. There is no regulatory requirement that any market participant connect to any one exchange, nor that any market participant connect at a particular connection speed or act in a particular capacity on the Exchange, or trade any particular product offered on an exchange. Moreover, membership is not a requirement to participate on the Exchange. Indeed, the Exchange is unaware of any one exchange whose membership includes every registered broker-dealer. The Exchange also believes substitutable products and services are available to market participants, including, among other things, other options exchanges that a market participant may connect to in lieu of the Exchange, indirect connectivity to the Exchange via a third-party reseller of connectivity, and/or trading of options products within markets which do not require connectivity to the Exchange, such as the Over-the-Counter (OTC) markets.
There are currently 17 exchanges offering options trading services. No single options exchange trades more than 14% of the options market by volume and only one of the 17 options exchanges has a market share over 10 percent.
As such, the Exchange must set its fees, including its fees for Remote Hands Services, competitively. If not, customers may move to other venues or reduce use of the Exchange's services. “If competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.”
In summary, the proposal represents an equitable allocation of reasonable dues, fees and other charges because Exchange fees have fallen in real terms and customers have a choice in trading
The Exchange believes that the proposed fee change is not unfairly discriminatory because the fee is assessed uniformly across all market participants that voluntarily purchase Remote Hands Services, which are available to all customers.
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 burdens inter-market competition (the competition among self-regulatory organizations) because approval of the proposal does not impose any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which market participants can determine whether or not to connect to the Exchange based on the value received compared to the cost of doing so. Indeed, market participants have numerous alternative exchanges that they may participate on and direct their order flow, as well as off-exchange venues, where competitive products are available for trading.
Nothing in the proposal burdens intra-market competition (the competition among consumers) because the Exchange's Remote Hands Services are available to any customer under the same fee schedule as any other customer, and any market participant that wishes to purchase such services can do so on a non-discriminatory basis.
No written comments were either solicited or received.
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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 the Exchange's fee for Remote Hands Services, as described further below.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on August 19, 2024.
The text of the proposed rule change is available on the Exchange's website at
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
The purpose of the proposed rule change is to amend a service fee relating to connectivity and co-location services. Specifically, the Exchange proposes to decrease its fee for Remote Hands Services, at General 8, Section 1, to $151.50 per hour.
General 8, Section 1 includes the Exchange's fees that relate to co-location services, including “Remote Hands Services.” The term “Remote Hands Services” refers to the use of Exchange engineers to perform on-site technical support tasks in its Data Center on behalf of its co-located customers, including the following: (1) power cycling of equipment; (2) patching and plugging in cabling and circuits; (3) observing, describing or reporting on display indicators; (4) configuration of hardware components instructed by the customer; (5) diagnosis and repairs as instructed by the customer; (6) swapping hardware components with customer-supplied spares or upgrades; (7) troubleshooting heat related issues as instructed by the Customer; and (8) returning defective equipment to the manufacturer or customer.
Earlier this year, the Exchange increased its $150 per hour fee for Remote Hands Services, along with other connectivity and co-location services, by 5.5%, to partially account for the cumulative effects of inflation on the value to the Exchange of the revenues it earns through such fees.
The purpose of the proposed change in the Exchange's Remote Hands Services fee is the same as that which the Exchange expressed when it increased the fee by 5.5% earlier this year. That is, the change would enable the Exchange to maintain and improve its market technology and services. Prior to SR-MRX-2024-18, the Exchange had not increased its Remote Hands fee since 2017.
The proposed fee represents a decrease in the existing $158 per hour rate, and a net overall 1% increase from the original $150 per month fee. The 1% fee increase, resulting in a proposed amended rate of $151.50 per hour, is far below the rates of inflation, as measured by either the CPI, the PPI, or the AHE since 2017. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2017. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. The Exchange notes that other exchanges have filed for comparable or higher increases in certain connectivity-related fees, based in part on similar rationale.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. These investments, and the value they provide to customers, far exceed the amount of the proposed net price increase over the prior $150 per hour rate. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
This belief is based on a couple factors. First, the current fee does not properly reflect the value of the service, as fees for the service in question has been static in nominal terms, and therefore falling in real terms due to inflation. Second, exchange fees are constrained by the fact that market participants can choose among 17 different venues for options trading, and therefore no single venue can charge excessive fees for its products without losing customers and market share.
As explained above, prior to SR-MRX-2024-18, the Exchange had not increased its Remote Hands Service fee since it introduced the fee in 2017. This means that this fee has fallen in real terms due to inflation, which has been notable. Between 2017 and 2024, the dollar had an average inflation rate of 3.34% per year, producing a cumulative price increase of 25.82%.
The proposed fee represents a decrease from the existing $158 per hour fee and a 1% overall net increase from the original $150 per hour fee, which is far below the rates of inflation, as measured by either the CPI, the PPI, or AHE since 2017. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2017. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. Again, these investments, and the value they provide to customers, far exceed the amount of the proposed price increase. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
Customers face many choices in where to trade options. Market participants will continue to choose trading venues and the method of connectivity based on their specific needs. No broker-dealer is required to become a Member of the Exchange. There is no regulatory requirement that any market participant connect to any one exchange, nor that any market participant connect at a particular connection speed or act in a particular capacity on the Exchange, or trade any particular product offered on an exchange. Moreover, membership is not a requirement to participate on the Exchange. Indeed, the Exchange is unaware of any one exchange whose membership includes every registered broker-dealer. The Exchange also believes substitutable products and services are available to market participants, including, among other things, other options exchanges that a market participant may connect to in lieu of the Exchange, indirect connectivity to the Exchange via a third-party reseller of connectivity, and/or trading of options products within markets which do not require connectivity to the Exchange, such as the Over-the-Counter (OTC) markets.
There are currently 17 exchanges offering options trading services. No single options exchange trades more than 14% of the options market by volume and only one of the 17 options exchanges has a market share over 10 percent.
As such, the Exchange must set its fees, including its fees for Remote Hands Services, competitively. If not, customers may move to other venues or reduce use of the Exchange's services. “If competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.”
In summary, the proposal represents an equitable allocation of reasonable dues, fees and other charges because Exchange fees have fallen in real terms and customers have a choice in trading venue and will exercise that choice and
The Exchange believes that the proposed fee change is not unfairly discriminatory because the fee is assessed uniformly across all market participants that voluntarily purchase Remote Hands Services, which are available to all customers.
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 burdens inter-market competition (the competition among self-regulatory organizations) because approval of the proposal does not impose any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which market participants can determine whether or not to connect to the Exchange based on the value received compared to the cost of doing so. Indeed, market participants have numerous alternative exchanges that they may participate on and direct their order flow, as well as off-exchange venues, where competitive products are available for trading.
Nothing in the proposal burdens intra-market competition (the competition among consumers) because the Exchange's Remote Hands Services are available to any customer under the same fee schedule as any other customer, and any market participant that wishes to purchase such services can do so on a non-discriminatory basis.
No written comments were either solicited or received.
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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 Exchange Rule 531, Reports and Market Data Products, to: (1) adopt rule text for the “Liquidity Taker Event Report—Complex Orders”; (2) adopt rule text for the “Liquidity Taker Event Report—Resting Simple Orders”; and (3) make non-substantive, clarifying changes to current Exchange Rules 531(a) and (b).
The text of the proposed rule change is available on the Exchange's website at
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 currently offers the Liquidity Taker Event Report (referred to herein as the “Simple Order Report”), which is a Member
The proposed Complex Order Report would be substantially similar to the existing Simple Order Report, but would include data concerning a Member's complex orders.
The Simple Order Report includes information about incoming orders seeking to remove resting orders from the Simple Order Book. The proposed Complex Order Report would include the same information about incoming complex orders that seek to remove complex orders resting on the Strategy Book.
Like the Simple Order Report, the proposed Complex Order Report is an optional product
Members generally would use a liquidity accessing order if there is a high probability that it will execute against an order resting on the Exchange's Simple Order Book. Like the Simple Order Report, the proposed Complex Order Report would identify by how much time an order that may have been marketable missed an execution. In the case of the proposed Complex Order Report, the incoming order would be a complex order submitted to trade against a resting order for a complex strategy. The proposed Complex Order Report will provide greater visibility into the missed trading execution, which will allow Members to optimize their models and trading patterns to yield better execution results when trading complex orders.
Like the Simple Order Report, the proposed Complex Order Report will be a Member-specific report and will help Members to better understand by how much time a particular order, in this case a complex order, missed executing against a specific resting order, thus allowing that Member to determine whether it wants to invest in the necessary resources and technology to mitigate missed executions against certain resting orders on the Exchange's Strategy Book. For example, Member A submits a complex order that is posted to the Strategy Book and then, within 400 microseconds of the entry of Member A's complex order, Member B enters a marketable complex order to execute against Member A's resting complex order. Immediately thereafter, Member C, also within 400 microseconds of the entry of Member A's complex order, sends a marketable complex order to execute against Member A's resting complex order. Because Member B's complex order is received by the Exchange before the complex order for Member C, Member B's complex order executes against Member A's resting complex order. If Member C were to subscribe to the proposed Complex Order Report, it would be provided the data points necessary for that firm to calculate by how much time it missed executing against Member A's resting complex order.
Like the Simple Order Report, the Exchange proposes to provide the proposed Complex Order Report on a T+1 basis. As further described below, the proposed Complex Order Report will be specifically tailored to the Member that is subscribed to the Complex Order Report and any data included in the Complex Order Report that relates to a Member other than the Member receiving the Complex Order Report will be anonymized.
The Exchange's affiliates, MIAX and MIAX Emerald, adopted their comparable Complex Order Reports in response to demand from their members for data concerning the timeliness of their incoming complex orders and executions against resting orders on those markets.
Similar to current Exchange Rule 531(a) regarding the Simple Order Report, amended Exchange Rule 531(b) would provide that the proposed Complex Order Report is a daily report that provides a Recipient Member with its liquidity response time details for executions of an order resting on the Strategy Book, where that Recipient Member submitted a complex order that attempted to execute against such resting complex order within a certain timeframe.
The content of the proposed Complex Order Report would be identical to the Simple Order Report, but for two minor differences discussed below. Proposed paragraph (b)(1) of Exchange Rule 531 would describe the content of the proposed Complex Order Report and delineate which information would be provided regarding the resting order,
Amended Exchange Rule 531(b)(1)(i) would provide that the following information would be included in the proposed Complex Order Report regarding the resting order: (A) the time the resting order was received by the Exchange;
The content of the proposed Complex Order Report set forth under amended Exchange Rule 531(b)(1)(ii) is identical to the content of the Simple Order Report under Exchange Rule 531(a)(1)(ii) with two minor differences. The Simple Order Report includes the SBBO, which is the Exchange's best bid or offer, and the ABBO, which is the best bid or offer of away exchanges. In their place, the proposed Complex Order Report would include the Complex SBBO and Complex ABBO. The Complex SBBO is calculated using the SBBO for each component of a complex strategy to establish the Exchange's best net bid or offer for a complex strategy. As discussed above, the Complex SBBO is calculated using the icSBBO
The timeframe for data to be included the proposed Complex Order Report set forth under amended Exchange Rule 531(b)(2) is identical to the timeframe for data included in the Complex Order Reports that are available for MIAX and MIAX Emerald.
The scope of data to be included the proposed Complex Order Report set forth under amended Exchange Rule 531(b)(3) is identical to the scope of data included in the Simple Order Report
Proposed paragraph (b)(4) of Exchange Rule 531 would specify that the Complex Order Report will contain historical data from the prior trading day and will be available after the end of the trading day, generally on a T+1 basis. This is identical to the timeframe for when the Simple Order Report is made available.
The Exchange proposes to amend Exchange Rule 531 to provide for the new Resting Simple Order Report.
The Exchange believes the additional data points from the matching engine outlined below for the proposed Resting Simple Order Report may also help Members gain a better understanding about their interactions with the Exchange. The Exchange believes the proposed Resting Simple Order Report will provide Members with an opportunity to learn more about better opportunities to access liquidity and receive better execution rates. The proposed Resting Simple Order Report will increase transparency and democratize information so that all firms that subscribe to the proposed Resting Simple Order Report have access to the same information on an equal basis, even for firms that do not have the appropriate resources to generate a similar report regarding interactions with the Exchange. None of the components of the proposed Resting Simple Order Report include real-time market data.
Members generally would use a liquidity accessing order if there is a high probability that it will execute against an order resting on the Simple Order Book. The proposed Resting Simple Order Report would identify by how much time an order that may have been marketable missed an execution but would focus on a later timeframe than the Simple Order Report and Complex Order Report. The proposed Resting Simple Order Report will provide greater visibility into the missed trading execution, which will allow Members to optimize their models and trading patterns to yield better execution results.
The proposed Resting Simple Order Report will be a Member-specific report and will help Members to better understand by how much time a particular order missed executing against a specific resting order, thus allowing that Member to determine whether it wants to invest in the necessary resources and technology to mitigate missed executions against certain resting orders on the Simple Order Book. The Exchange proposes to provide the Resting Simple Order Report on a T+1 basis. As further described below, the proposed Resting Simple Order Report will be specific and tailored to the Member that is subscribed to the Resting Simple Order Report and any data included in the Resting Simple Order Report that relates to a Member other than the Member receiving the Resting Simple Order Report will be anonymized.
The Exchange's affiliates, MIAX, MIAX Pearl, and MIAX Emerald, adopted their comparable Resting Simple Order Reports in response to demand from their members for data concerning the timeliness of their incoming orders and executions against certain resting orders that have been resting on the Simple Order Books of MIAX, MIAX Pearl, and MIAX Emerald, for at least 200 microseconds and within 200 microseconds of receipt of the first attempt to execute against the resting order after the initial 200 microsecond time period has expired.
Proposed Exchange Rule 531(c) would provide that the Resting Simple Order Report is a daily report that provides a Recipient Member with its liquidity response time details for executions of an order resting on the Simple Order Book, where that Recipient Member attempted to execute against such resting order within an extended timeframe that meets certain criteria described below.
The content of the proposed Resting Simple Order Report is basically identical to that of the existing Simple Order Report described under Exchange Rule 531(a) with two differences. The first difference is the timeframe of the proposed Resting Simple Order Report mentioned above and described in more detail below. The second difference is that, unlike the existing Simple Order Report, the proposed Resting Simple Order Report would not include the time difference between the time the resting order was received by the Exchange and the time the first response that executes against the resting order was received by the Exchange. Each of these differences are described below. All other aspects of the proposed Resting Simple Order Report are identical to the existing Simple Order Report described under Exchange Rule 531(a).
Like current paragraph (a)(1) of Exchange Rule 531 for the existing Simple Order Report, proposed paragraph (c)(1) of Exchange Rule 531 would describe the content of the proposed Resting Simple Order Report and delineate which information would be provided regarding the resting
Exchange Rule 531(a)(1)(ii)(D) provides that the existing Simple Order Report also includes the time difference between the time the resting order was received by the Exchange and the time the first response that executes against the resting order was received by the Exchange. The proposed Resting Simple Order Report would not include the same information because that timeframe could be for an extended period of time since the proposed Resting Simple Order Report focuses on orders that have been resting on the Simple Order Book for longer than 200 microseconds and, therefore, the Exchange believes is less likely to be valuable to the Recipient Member.
The timeframe covered by the proposed Resting Simple Order Report is the primary difference between it and the existing Simple Order Report. The existing Simple Order Report provides data for executions and contra-side responses that occurred within 200 microseconds of the time the resting order was received by the Exchange. Meanwhile, the proposed Resting Simple Order Report would include the same data as the Simple Order Report but would focus on executions and contra-side responses that occurred after 200 microseconds of the time the resting order was received by the Exchange, and within 200 microseconds of receipt of any Member's first attempt to execute against the resting order after the initial 200 microsecond time period has expired. More specifically, the resting order must rest on the Simple Order Book for at least 200 microseconds and once that initial 200 microsecond period has passed, a Member must then submits an order to attempt to execute against that resting order. This event starts a second 200 microsecond period within which the proposed Resting Simple Order Report would include data on executions and contra-side responses submitted by the Recipient Member to execute against that resting order.
For example, Member A submits an order that is posted to the Simple Order Book. 200 microseconds passes and Member A's order remains posted to the Simple Order Book. Then Member B enters a marketable order to execute against Member A's resting order, starting the second 200 microsecond window. Within this next 200 microsecond window, Member C sends a marketable order to execute against Member A's resting Order. Because Member B's order is received by the Exchange before Member C's order, Member B's order executes against Member A's resting order. The proposed Resting Simple Order Report would provide Member C the data points necessary for that firm to calculate by how much time it missed executing against Member A's resting order.
The above timeframe would be codified under proposed paragraph (c)(2) of Exchange Rule 531 which would provide that the proposed Resting Simple Order Report would include the data set forth under Exchange Rule 531(c)(1) described above for executions and contra-side responses that occurred (i) after 200 microseconds of the time the resting order was received by the Exchange and (ii) within 200 microseconds of receipt
Like current paragraph (a)(3) of Exchange Rule 531 for the existing Simple Order Report, proposed paragraph (c)(3) of Exchange Rule 531 would provide that the proposed Resting Simple Order Report will only include trading data related to the Recipient Member and, subject to the proposed paragraph (4) of Exchange Rule 531(c) described below, will not include any other Member's trading data other than that listed in paragraphs (1)(i) and (ii) of proposed Exchange Rule 531(c), described above.
Like current paragraph (a)(4) of Exchange Rule 531 for the existing Simple Order Report, proposed paragraph (c)(4) of Exchange Rule 531 would specify that the proposed Resting Simple Order Report will contain historical data from the prior trading day and will be available after the end of the trading day, generally on a T+1 basis.
The Exchange believes the proposed rule changes are consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of section 6(b) of the Act.
But for three differences, the description of the proposed Complex Order Report under Exchange Rule 531(b) is identical to that of the Simple Order Report under Exchange Rule 531(a). The first difference concerns the content of the proposed Complex Order Report, which would be limited to incoming complex orders that seek to remove liquidity from the Exchange's Strategy Book. The Simple Order Report includes information about incoming orders seeking to remove liquidity from the Simple Order Book. This difference is immaterial because both reports include basically the same information and seek to serve the same purpose, to provide the Recipient Member with the same type of data necessary for them to evaluate their own trading behavior and order interactions on the Exchange; however, the Simple Order Report contains data relevant to the Simple Order Book while the proposed Complex Order Report contains data relevant to the Strategy Book.
The other two differences are that the Simple Order Report includes the SBBO, which is the Exchange's best bid or offer, and the ABBO, which is the best bid or offer of away exchanges. In their place, the proposed Complex Order Report would include the Complex SBBO and Complex ABBO. As discussed above, the Complex SBBO is calculated using the icSBBO combined with the best price currently available on the Strategy Book to establish the Exchange's best net bid or offer for a complex strategy.
The timeframe covered by the proposed Resting Simple Order Report is the primary difference between it and the existing Simple Order Report. However, this difference only pertains to the timeframe covered by each report, with each report containing the exact same data fields with one exception described here. The existing Simple Order Report provides data for executions and contra-side responses that occurred within 200 microseconds of the time the resting order was received by the Exchange. Meanwhile, the proposed Resting Simple Order Report would basically include the same data as the Simple Order Report but would focus on executions and contra-side responses that occurred after 200 microseconds of the time the resting order was received by the Exchange and one additional difference. The one difference is that unlike the existing Simple Order Report, the proposed Resting Simple Order Report would not include the time difference between the time the resting order and first response that executes against the resting order are received by the Exchange. Each report focuses on 200 microsecond windows with the existing Simple Order Report's window starting at the time of receipt of the resting order and the proposed Resting Simple Order Report's window starting with the first attempt to execute against the resting order after the order was resting on the Simple Order Book for at least 200 microseconds.
Like the Simple Order Report, the Exchange believes the proposed Complex Order Report and Resting Simple Order Report will serve to promote just and equitable principles of trade, 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 by providing Members access to information regarding their trading activity that they may utilize to evaluate their own trading behavior and order interactions. Also, like the Simple Order Report, the proposed Complex Order Report is designed for Members that are interested in gaining insight into latency in connection with complex orders that failed to execute against an order resting on the Exchange's Strategy Book by providing those Members data to analyze by how much time their complex order may have missed an execution against a contra-side order resting on the Strategy Book. Like the existing Simple Order Report, the proposed Resting Simple Order Report is designed for Members that are interested in gaining insight into latency in connection with orders that failed to execute against an order resting on the Exchange's Simple Order Book by
As discussed above, the Exchange's affiliates, MIAX, MIAX Pearl and MIAX Emerald, received ad hoc requests from their members for information regarding the timeliness of their attempts to execute against resting options liquidity on Strategy Books and Simple Order Books of those markets. The proposal promotes just and equitable principles of trade because it would provide latency information in a systematized way and standardized format to any Member that chooses to subscribe to the proposed Complex Order Report or Resting Simple Order Report. As a result, the proposal would also remove impediments to and perfect the mechanism of a free and open market and a national market system by making latency information for liquidity-seeking orders available in a more equalized manner.
The proposal further promotes just and equitable principles of trade by increasing transparency, particularly for Recipient Members of either or both the Complex Order Report and Resting Simple Order Report that may not have the expertise to generate the same information on their own. The proposed Complex Order Report may better enable Recipient Members to increase the fill rates for their liquidity-seeking Complex Orders and the Resting Simple Order Report may better enable Recipient Members to increase the fill rates for their liquidity-seeking orders. At the same time, as is also discussed above, the Complex Order Report and Resting Simple Order Report promote just and equitable principles of trade and protect investors and the public interest because they are designed to prevent a Recipient Member of either report from learning other Members' sensitive trading information. The Complex Order Report and Resting Simple Order Report would not be real-time market data products, as they would provide only historical trading data for the previous trading day, generally on a T+1 basis. In addition, the data in the Complex Order Report regarding incoming orders that failed to execute would be specific to the Recipient Member's complex orders, and other information in the proposed Complex Order Report regarding resting orders and executions would be anonymized if it relates to a Member other than the Recipient Member. The same is true for the Resting Simple Order Report.
The Complex Order Report and Resting Simple Order Report generally would contain three buckets of information each. The first two buckets include information about the resting order and the execution of the resting order. The Exchange anticipates that this information will be available from the Exchange's proprietary data feeds or derivable from OPRA. For example, for the Complex Order Report, the Exchange plans to offer the Complex Top of Market (“cToM”) data feed which will provide real-time quote and last sale information for all displayed orders on the Strategy Book.
The first bucket of information contained in the proposed Complex Order Report and Resting Simple Order Report for the resting order includes the time the resting order was received by the Exchange, the symbol, unique reference number assigned at the time of receipt, side (buy or sell), and the displayed price and size of the resting order. The symbol, origin type, side (buy or sell), and displayed price and size are also available via the Exchange's proprietary data feeds depending on which report a Member subscribes to. The first bucket of information for both proposed reports would also indicate whether the Recipient Member is an Affiliate of the Member that entered the resting order. This data field for both proposed reports would not indicate the identity of the Member that entered the resting order and would simply allow the Recipient Member to better understand the scenarios in which it may execute against the orders of its Affiliates.
For the proposed Complex Order Report, the second bucket of information pertains to the execution of the resting order and includes the Complex SBBO and Complex ABBO at the time of execution and for the proposed Resting Simple Order Report, pertains to the execution of the resting order and includes the SBBO and ABBO at the time of execution. These data points for both proposed reports are also derivable from information disseminated via OPRA or available via the Exchange's proprietary data feeds, depending on the type of report. The second bucket of information for both reports would also indicate whether the response was entered by the Recipient Member. For both reports, this data point would be simply provided as a convenience and, if not entered by the Recipient Member, this data point would be left blank so as not to include any identifying information about other Member activity. For the Complex Order Report, the second bucket of information would also include the size, time and type of first response
For both proposed reports, the third bucket of information would be about the Recipient Member's response(s) and the time their response(s) is received by the Exchange. This would include the time difference between the time the first response that executes against the resting order was received by the Exchange and the time of each response sent by the Recipient Member, regardless of whether it executed or not. As above, for both proposed reports, this data point would assist the Recipient Member in analyzing by how much time their order may have missed an execution against a contra-side order resting on the Strategy Book. This bucket would also include the size and type of each response submitted by the Recipient Member, the Recipient Member identifier, and a response reference number, which is selected by the Recipient Member. Each of these data points are unique to the Recipient Member and should already be known by the Recipient Member even if not included in the Complex Order Report or Resting Simple Order Report, as the case may be.
The Exchange proposes to provide the Complex Order Report and Resting Simple Order Report on a voluntary basis and no Member will be required to subscribe to either report. The Exchange notes that there is no rule or regulation that requires the Exchange to produce, or that a Member elect to receive, either proposed report. It would be entirely a business decision of each Member to subscribe to either proposed report. The Exchange proposes to offer the Complex Order Report and Resting Simple Order Report as a convenience to Members to provide them with additional information regarding trading activity on the Exchange on a delayed basis after the close of regular trading hours. A Member that chooses to subscribe to either proposed report may discontinue receiving either at any time if that Member determines that the information contained in the Complex Order Report or Resting Simple Order Report is no longer useful.
In summary, the proposed Complex Order Report and Resting Simple Order Report will help to protect a free and open market by providing additional data (offered on an optional basis) to the marketplace and by providing investors with greater choices.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
The proposed Complex Order Report and Resting Simple Order Report will allow the Exchange to provide new options for Members to receive historical market data. The proposed Complex Order Report and Resting Simple Order Report will also further enhance inter-market competition between exchanges by allowing the Exchange to expand its product offerings to include additional reports to provide latency information requested by Members. The latency information that would be provided in the proposed Complex Order Report and Resting Simple Order Report would enhance competition between exchanges because it would allow Recipient Members to recalibrate their models and trading strategies to improve their overall trading experience on the Exchange. This may improve the Exchange's overall trading environment resulting in increased liquidity and order flow on the Exchange. In response, other exchanges may similarly seek ways to provide latency related data in an effort to improve their own market quality. Further, at least one other competing exchange offers substantively identical reports as the Exchange's Simple Order Report and proposed Complex Order Report.
The proposed rule change to offer the optional Complex Order Report and Resting Simple Order Report is in response to Member interest and requests for such information at the Exchange's affiliates, MIAX and MIAX Emerald. The Exchange does not believe the proposed Complex Order Report or Resting Simple Order Report will have an inappropriate burden on intra-market competition between Recipient Members and other Members who choose not to receive either report. As discussed above, the first two buckets of information included in the Complex Order Report and Resting Simple Order Report (with one minor exception described above) contain information about the resting order and the execution of the resting order, both of which are generally available to Members that choose not to receive the Complex Order Report or Resting Simple Order Report from other sources, such as by deriving these data points from OPRA or obtaining them from the Exchange's proprietary data feeds. The third bucket of information pertains to the Recipient Member's response and the time their response is received by the Exchange, information which latency sensitive Members that do not subscribe to the proposed Complex Order Report or Resting Simple Order Report could obtain on their own based on their knowledge of when they sent their response to the Exchange and via timestamp information provided by the acknowledgment message received from the Exchange. However, latency sensitive Members that do not subscribe to the proposed Complex Order Report or Resting Simple Order Report would not be able to obtain the time difference between the time the first response that executes against the resting order was received by the Exchange and the time of each response sent by the Recipient Member. Such latency sensitive Members may not view this information as beneficial based on their own trading models and systems. Other Members
In sum, if the proposed Complex Order Report or Resting Simple Order Report is unattractive to Members, Members will opt not to receive either report. Accordingly, the Exchange does not believe that the proposed change will impair the ability of Members or competing order execution venues to maintain their competitive standing in the financial markets.
Written comments were neither solicited nor 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 after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, it has become effective 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 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 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.
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) granting an exemption from section 23(a)(1) of the Act.
Applicants request an order to permit certain registered closed-end management investment companies and business development companies (as defined under section 2(a)(48) of the Act) to pay investment advisory fees (as described in the application) in shares of their common stock.
Brookfield Asset Management Private Institutional Capital Adviser (Canada), L.P. and Brookfield Infrastructure Income Fund, Inc.
The application was filed on January 20, 2023, and amended on June 23, 2023, October 19, 2023, and May 7, 2024.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Kieran G. Brown, Senior Counsel, or Terri Jordan, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For applicants' representations, legal analysis, and conditions, please refer to applicants' third amended and restated application, dated May 7, 2024, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's fee for Remote Hands Services, as described further below.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on August 19, 2024.
The text of the proposed rule change is available on the Exchange's website at
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 purpose of the proposed rule change is to amend a service fee relating to connectivity and co-location services. Specifically, the Exchange proposes to decrease its fee for Remote Hands Services, at General 8, section 1, to $151.50 per hour.
General 8, section 1 includes the Exchange's fees that relate to co-location services, including “Remote Hands Services.” The term “Remote Hands Services” refers to the use of Exchange engineers to perform on-site technical support tasks in its Data Center on behalf of its co-located customers, including the following: (1) power cycling of equipment; (2) patching and plugging in cabling and circuits; (3) observing, describing or reporting on display indicators; (4) configuration of hardware components instructed by the customer; (5) diagnosis and repairs as instructed by the customer; (6) swapping hardware components with customer-supplied spares or upgrades; (7) troubleshooting heat related issues as instructed by the Customer; and (8) returning defective equipment to the manufacturer or customer.
Earlier this year, the Exchange increased its $150 per hour fee for Remote Hands Services, along with other connectivity and co-location services, by 5.5%, to partially account for the cumulative effects of inflation on the value to the Exchange of the revenues it earns through such fees.
The purpose of the proposed change in the Exchange's Remote Hands Services fee is the same as that which the Exchange expressed when it increased the fee by 5.5% earlier this year. That is, the change would enable the Exchange to maintain and improve its market technology and services. Prior to SR-ISE-2024-23, the Exchange had not increased its Remote Hands fee since 2017.
The proposed fee represents a decrease in the existing $158 per hour rate, and a net overall 1% increase from the original $150 per month fee. The 1% fee increase, resulting in a proposed amended rate of $151.50 per hour, is far below the rates of inflation, as measured by either the CPI, the PPI, or the AHE since 2017. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2017. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. The Exchange notes that other exchanges have filed for comparable or higher increases in certain connectivity-related fees, based in part on similar rationale.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. These investments, and the value they provide to customers, far exceed the amount of the proposed net price increase over the prior $150 per hour rate. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
The Exchange believes that its proposal is consistent with section 6(b) of the Act,
This belief is based on a couple factors. First, the current fee does not properly reflect the value of the service, as fees for the service in question has been static in nominal terms, and therefore falling in real terms due to inflation. Second, exchange fees are constrained by the fact that market participants can choose among 17 different venues for options trading, and therefore no single venue can charge excessive fees for its products without losing customers and market share.
As explained above, prior to SR-ISE-2024-23, the Exchange had not increased its Remote Hands Service fee since it introduced the fee in 2017. This means that this fee has fallen in real terms due to inflation, which has been notable. Between 2017 and 2024, the dollar had an average inflation rate of 3.34% per year, producing a cumulative price increase of 25.82%.
The proposed fee represents a decrease from the existing $158 per hour fee and a 1% overall net increase from the original $150 per hour fee, which is far below the rates of inflation, as measured by either the CPI, the PPI, or AHE since 2017. Although the Exchange believes it would be reasonable to increase the fee by an amount equal to the full rates of inflation, however measured, to reestablish the initial value of the revenues it earns through its fees, the Exchange does not propose to do this. In fact, the Exchange now proposes to recalibrate even its initial 5.5% fee increase, because the Exchange is sensitive to the sticker shock that customers may experience when the Exchange raises rates. Instead, the Exchange proposes only a modest 1% increase over the prior $150 per month rate, an amount that the Exchange believes to be reasonable on its face as it is significantly less than various measures of inflation discussed above, and even less than the original 5.5% increase.
The Exchange believes that it is reasonable to increase its fee to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2017. The Exchange notes that this inflationary effect is a general phenomenon that is independent of any change in the Exchange's costs in providing its goods and services. The Exchange believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects.
In addition, the Exchange continues to invest in maintaining, improving, and enhancing its connectivity and co-location products, services, and facilities—for the benefit and often at the behest of its customers. Such enhancements include refreshing hardware and expanding the Exchange's existing co-location facility to offer customers additional space and power. Again, these investments, and the value they provide to customers, far exceed the amount of the proposed price increase. It is reasonable and consistent with the Act for the Commission to allow the Exchange to recoup these investments by charging fees, lest the Commission will disincentivize the Exchange to make similar investments in the future—a result that would be detrimental to the Exchange's competitiveness as well as the interests of market participants and investors.
Customers face many choices in where to trade options. Market participants will continue to choose trading venues and the method of connectivity based on their specific needs. No broker-dealer is required to become a Member of the Exchange. There is no regulatory requirement that any market participant connect to any one exchange, nor that any market participant connect at a particular connection speed or act in a particular capacity on the Exchange, or trade any particular product offered on an exchange. Moreover, membership is not a requirement to participate on the Exchange. Indeed, the Exchange is unaware of any one exchange whose membership includes every registered broker-dealer. The Exchange also believes substitutable products and services are available to market participants, including, among other things, other options exchanges that a market participant may connect to in lieu of the Exchange, indirect connectivity to the Exchange via a third-party reseller of connectivity, and/or trading of options products within markets which do not require connectivity to the Exchange, such as the Over-the-Counter (OTC) markets.
There are currently 17 exchanges offering options trading services. No single options exchange trades more than 14% of the options market by volume and only one of the 17 options exchanges has a market share over 10 percent.
As such, the Exchange must set its fees, including its fees for Remote Hands Services, competitively. If not, customers may move to other venues or reduce use of the Exchange's services. “If competitive forces are operative, the self-interest of the exchanges themselves will work powerfully to constrain unreasonable or unfair behavior.”
In summary, the proposal represents an equitable allocation of reasonable dues, fees and other charges because Exchange fees have fallen in real terms and customers have a choice in trading venue and will exercise that choice and trade at another venue if exchange fees are not set competitively.
The Exchange believes that the proposed fee change is not unfairly discriminatory because the fee is assessed uniformly across all market participants that voluntarily purchase Remote Hands Services, which are available to all customers.
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 burdens inter-market competition (the competition among self-regulatory organizations) because approval of the proposal does not impose any burden on the ability of other exchanges to compete. The Exchange operates in a highly competitive market in which market participants can determine whether or not to connect to the Exchange based on the value received compared to the cost of doing so. Indeed, market participants have numerous alternative exchanges that they may participate on and direct their order flow, as well as off-exchange venues, where competitive products are available for trading.
Nothing in the proposal burdens intra-market competition (the
No written comments were either solicited or received.
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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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.
U.S. Small Business Administration.
Notice of Small Business Investment Company (SBIC) Licenses.
Pursuant to the authority granted to the United States Small Business Administration under section 301(c) of the Small Business Investment Act of 1958, as amended, to grant Small Business Investment Company licenses under the Small Business Investment Company Program, this notice satisfies the requirement effective August 17, 2023 under 13 CFR 107.501(a) to publish in the
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Kentucky (FEMA-4804-DR), dated 07/23/2024.
Issued on 08/02/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the Commonwealth of Kentucky, dated 07/23/2024, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative disaster declaration of a rural area for the State of Idaho dated 08/02/2024.
Issued on 08/02/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration of a rural area, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 204376 and for economic injury is 204380.
The State which received an EIDL Declaration is Idaho.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Iowa (FEMA-4796-DR), dated 07/24/2024.
Issued on 08/02/2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of IOWA, dated 07/24/2024, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 6.
This is an amendment of the Presidential declaration of a major disaster for the State of Iowa (FEMA-4796-DR), dated 06/24/2024.
Issued on 08/02/2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Iowa, dated 06/24/2024, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4798-DR), dated 07/12/2024.
Issued on 08/02/2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Texas, dated 07/12/2024, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
By virtue of the authority vested in me by section 7045(a)(2)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2023 (div. K, Pub. L. 117-328) (FY 2023 SFOAA) and Department of State Delegation of Authority 513, I hereby certify that the central government of Guatemala is:
i. combating corruption and impunity, including investigating and prosecuting government officials, military personnel, and police officers credibly alleged to be corrupt;
ii. implementing reforms, policies, and programs to strengthen the rule of law, including increasing the transparency of public institutions, strengthening the independence of judicial and electoral institutions, and improving the transparency of political campaign and political party financing;
iii. protecting the rights of human rights defenders, trade unionists, journalists, civil society groups, opposition political parties, and the independence of the media;
iv. providing effective and accountable law enforcement and security for its citizens, curtailing the role of the military in public security, and upholding due process of law;
v. implementing programs to reduce violence against women and girls;
vi. implementing policies to reduce poverty and promote economic growth and opportunity, including the implementation of reforms to strengthen educational systems, vocational training programs, and programs for at-risk youth;
vii. improving border security and combating human smuggling and trafficking and countering the activities of criminal gangs, drug traffickers, and transnational criminal organizations;
viii. informing its citizens of the dangers of the journey to the southwest border of the United States; and
ix. implementing policies that improve the environment for foreign investment, including executing tax reform in a transparent manner, ensuring effective legal mechanisms for reimbursements of tax refunds owed to United States businesses, and resolving disputes involving the confiscation of real property of United States entities.
This certification shall be published in the
Department of State.
Notice of extension of passport travel restriction.
On September 1, 2017, all U.S. passports were declared invalid for travel to, in, or through the Democratic People's Republic of Korea (DPRK), unless specially validated for such travel. The restriction was extended for one year in 2018, 2019, 2020, 2021, 2022, and 2023 and, if not renewed, the restriction is set to expire on August 31, 2024. This notice extends the restriction until August 31, 2025, unless extended or revoked by the Secretary of State.
The extension of the travel restriction is in effect on September 1, 2024.
Jennifer Tinianow, Bureau of Consular Affairs, Passport Services, Office of Adjudication, 202-765-6517.
On September 1, 2017, pursuant to the authority of 22 U.S.C. 211a and Executive Order 11295 (31 FR 10603), and in accordance with 22 CFR 51.63(a)(3), all U.S. passports were declared invalid for travel to, in, or through the DPRK unless specially validated for such travel. The restriction was renewed on September 1 in each year from 2018 through 2023. If not renewed again, the restriction is set to expire on August 31, 2024.
The Department of State has determined there continues to be serious risk to U.S. citizens and nationals of arrest and long-term detention constituting imminent danger to their physical safety, as defined in 22 CFR 51.63(a)(3). Accordingly, all U.S. passports shall remain invalid for travel to, in, or through the DPRK unless specially validated for such travel under the authority of the Secretary of State. This extension to the restriction of travel to the DPRK shall be effective on September 1, 2024, and shall expire August 31, 2025, unless extended or revoked by the Secretary of State.
By virtue of the authority vested in the Secretary of State by the laws of the United States, including 22 U.S.C. 2651a and section 7016(b)(2)(A) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2024 (div. F, Pub. L. 118-47), I hereby delegate to the Under Secretary for Political Affairs and the Under Secretary for Management, to the extent authorized by law, the authority to determine that the public posting of a report to the Congress would compromise national security, including the conduct of diplomacy, or the report contains proprietary or other privileged information.
The reference in this delegation of authority to a statute shall be deemed to be a reference to such statute as amended from time to time and shall be deemed to apply to any provision of law that is the same or substantially the same as such statute. This delegation of authority does not repeal or modify any other delegation of authority currently in effect.
The Secretary, Deputy Secretary, or Deputy Secretary for Management and Resources may exercise any authority or function delegated herein.
This memorandum shall be published in the
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that by letter received on April 12, 2024, Capital Metropolitan Transportation Authority (CMTY) petitioned the Federal Railroad Administration (FRA) for an extension of a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 222 (Use of Locomotive Horns at Public Highway-Rail Grade Crossings), part 229 (Railroad Locomotive Safety Standards), part 231 (Railroad Safety Appliance Standards), part 234 (Grade Crossing Safety), and part 238 (Passenger Equipment Safety Standards). The relevant Docket Number is FRA-2006-25040.
Specifically, CMTY requested to extend its existing relief for its commuter rail system that connects downtown Austin, Texas, with Austin's northern suburbs along 32 miles with 9 stations. CMTY seeks to continue operating a fleet of 6 Stadler GTW diesel multiple unit (DMU) rail vehicles that have operated on the line since 2010. CMTY requests extended relief from the following regulations:
In support of its request, CMTY explained that their vehicles demonstrate “an equivalent level of safety and compliance,” given the Alternative Vehicle Technology final rule amendments in 49 CFR part 238. CMTY also noted that in this renewal request, they are seeking relief from fewer specific regulatory provisions than previously granted for this fleet of vehicles.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by October 7, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of the U.S. Department of Transportation's (DOT) dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that by letter received May 24, 2024, a private owner, Tierney Foster Abel (Mr. Abel), petitioned the Federal Railroad Administration (FRA) to extend a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR parts 223 (Safety Glazing Standards—Locomotives, Passenger Cars and Cabooses) and 231 (Railroad Safety Appliance Standards). FRA assigned the petition Docket Number FRA-2024-0068.
Specifically, Mr. Abel requests relief for steam locomotive HLLR 331 from the safety glazing standards in part 223, as well as § 231.15(b) and (d),
The relief is requested because installation of FRA safety glazing will “substantially change the historic configuration and appearance of the cab” and thereby “ruin the historical appearance.” Additionally, Mr. Abel states that HLLR 331 will not be used for coupling but instead, the locomotive and tender will be “connected by a draw bar that is . . . secured in place so it cannot be removed or otherwise come apart.” Therefore, the “step requirements are unnecessary” and the handholds would “substantially detract from the historic appearance” as the locomotive cab and tender are substantially different heights.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by October 7, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of the U.S. Department of Transportation's (DOT) dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that by letter received June 3, 2024, BNSF Railway Company (BNSF) petitioned the Federal Railroad Administration (FRA) to extend the existing test waiver of compliance in Docket Number FRA-2016-0086. The existing relief in this docket provides BNSF, CSX Transportation (CSX), and Kansas City Southern Railway (now known as CPKC) conditional relief from certain provisions of the Federal railroad safety regulations contained at 49 CFR parts 232 (Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment; End-Of-Train Devices), and 229 (Railroad Locomotive Safety Standards). Specifically, the existing relief allows the railroads to test extending the air flow method (AFM) test intervals from
In support of its request, BNSF states that “throughout the life of th[e] waiver, the data collected and reported to the FRA has conclusively established that the AFM indicator can successfully and safely maintain calibration setting for a period of at least 184 days,” citing that in a period measured from June to December 2023, “98% of BNSF's AFM indicators have tested as in-calibration at the 184-day mark.” BNSF also notes that the relief “has crucially enabled alignment between the AFM indicator-calibration interval and the interval for federally mandated periodic locomotive inspections,” as well as additional safety benefits described in the request.
In this petition, BNSF notes that it also seeks to transition this waiver to a permanent waiver in the future, but at this time, is requesting a five-year extension.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by October 7, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of the U.S. Department of Transportation's (DOT) dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that by letter received June 3, 2024, Texas State Railroad/Texas & Eastern Railroad (Petitioner) petitioned the Federal Railroad Administration (FRA) to extend the existing waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 240 (Qualification and Certification of Locomotive Engineers). The relevant Docket Number is FRA-2018-0084.
Specifically, Petitioner requests continued relief from § 240.201,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by October 7, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of the U.S. Department of Transportation's (DOT) dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Maritime Administration, DOT.
Notice of public meeting.
The U.S. Department of Transportation, Maritime Administration (MARAD) announces a meeting of the U.S. Merchant Marine Academy (USMMA) Advisory Council (Council). During the meeting, the USMMA leadership will provide an update on programs and priorities, including governance, sexual assault and sexual harassment, academics, culture and diversity, and facilities and infrastructure.
August 29, 2024, from 1:00 p.m. to 3:00 p.m. EST. Written statements to be considered during the meeting must be received via email to
The meeting will be held through a virtual forum. Virtual meeting access information will be available on the USMMA Advisory Council web page and social media channels no later than August 23, 2024. General information about the Council is available at
The Council's Designated Federal Officer and Point of Contact, Mary Grice, 202-366-4264 or via email to
The Council is established pursuant to 46 U.S.C. 51323. The Council operates in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. ch. 10.
The objective and scope of the Council is to provide independent advice and recommendations to the Secretary of Transportation (Secretary) on matters relating to USMMA including in the areas of curriculum development and training programs; diversity, equity, and inclusion; sexual assault prevention and response; infrastructure maintenance and redevelopment; midshipmen health and welfare; governance and administrative policies; and other matters.
The meeting agenda will cover, but is not limited to, the following proposed topics:
1. Welcome and opening remarks
2. Public comments
3. Advisory Council's Report
4. Administrative items
This meeting is open to the public and will be held through a virtual forum. 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, such as sign language, interpretation, or other ancillary aids, please contact the person listed in the
Any member of the public is permitted to file a written statement with the Council. Written statements should be sent to the Designated Federal Officer listed in the
Only written statements will be considered by the Council; no member of the public will be allowed to present questions or speak during the meeting unless requested to do so by a member of the Council.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice, correction.
On August 2, 2024, the Maritime Administration (MARAD) published a document in the
Comments must be submitted on or before October 7, 2024.
You may submit comments identified by Docket No. MARAD-2024-0103 through one of the following methods:
•
•
All comments received will be posted without change to
Comments are invited on: (a) whether the proposed collection of information is necessary for the Department's performance; (b) the accuracy of the estimated burden; (c) ways for the Department to enhance the quality, utility, and clarity of the information collection; and (d) ways that the burden could be minimized without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB's clearance of this information collection.
Cameryn L. Miller, 202-366-0907, Office of Marine Insurance, Maritime Administration, U.S. Department of Transportation, 1200 New Jersey Ave. SE, Washington, DC 20590, Email:
By Order of the Maritime Administrator.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Office of Hazardous Materials Safety, and the Federal Aviation Administration (FAA), Security and Hazardous Materials Safety, Department of Transportation (DOT).
Notice of public meeting.
This notice announces that PHMSA and FAA will host a public meeting to solicit input on implementing provisions in the FAA Reauthorization Act of 2024. This section relates to the transportation of hazardous materials by unmanned aircraft systems (UAS).
This meeting will take place on August 22, 2024, from 1 p.m. to 4 p.m., Eastern Time.
The public meeting will be a web conference. Specific information for this meeting will be posted on the PHMSA website under “Upcoming Events” at
Steven Andrews, 202-366-8553, Standards and Rulemaking Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or
Lori Ambers, 405-954-0088, Office of Hazardous Materials Safety, Federal Aviation Administration, U.S. Department of Transportation, 800 Independence Avenue SW, Washington, DC 20591-0001.
On May 16, 2024, President Biden signed the Federal Aviation Administration (FAA) Reauthorization Act of 2024
This joint public meeting, hosted by PHMSA and the FAA, addresses the statutory requirement in § 933, subsection (e)(1) of the FAA Reauthorization Act. PHMSA and the FAA encourage participation in this public meeting from stakeholders and the public to help advance the development of policy for UAS delivery of packages containing hazardous materials.
At this meeting, PHMSA and the FAA will provide a brief background discussion on § 933 of the FAA Reauthorization Act of 2024. Following this introduction, PHMSA and the FAA will solicit input from the public on actions necessary to implement § 933.
The meeting will be open to the public; however, any member of the public who wishes to attend must RSVP to obtain login instructions and access using the following:
PHMSA is committed to providing equal access for all citizens and ensuring that information is available in appropriate alternative formats to meet the requirements of persons who have a disability. If you require an alternative version of files provided or alternative accommodations, please contact
Financial Crimes Enforcement Network (FinCEN), Treasury.
Notice and request for comments.
As part of its continuing effort to reduce paperwork and respondent burden, FinCEN invites comments on the proposed renewal, without change, of existing information collection requirements found in Bank Secrecy Act regulations that require a bank to file a FinCEN Form 110, Designation of Exempt Person, to designate eligible customers as exempt persons, such that a bank is not required to file a report
Written comments are welcome and must be received on or before October 7, 2024.
Comments may be submitted by any of the following methods:
•
•
Please submit comments by one method only. Comments will be reviewed consistent with the Paperwork Reduction Act of 1995 (PRA) and applicable OMB regulations and guidance. All comments submitted in response to this notice will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
FinCEN's Regulatory Support Section at 1-800-767-2825 or electronically at
The legislative framework generally referred to as the Bank Secrecy Act (BSA) consists of the Currency and Foreign Transactions Reporting Act of 1970, as amended by the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act)
The BSA authorizes the Secretary of the Treasury (Secretary) to,
Under 31 U.S.C. 5313, the Secretary is authorized to require financial institutions to report currency transactions exceeding $10,000. Regulations implementing 31 U.S.C. 5313 are found at 31 CFR 1010.310 through 1010.314, 31 CFR 1021.311, and 31 CFR 1021.313. The Money Laundering Suppression Act of 1994 amended the BSA to create certain mandatory exemptions applicable to banks from the requirement for financial institutions to file currency transaction reports (CTRs), and to give the Secretary authority to create additional such exemptions.
Under 31 CFR 1020.315(a), a bank is not required to file a CTR with respect to any transaction in currency between exempt persons and the bank, or between an exempt person and other banks that are affiliated with the bank.
31 CFR 1020.315(b) sets out that an exempt person is: (1) a bank, to the extent of such bank's domestic operations; (2) a department or agency of the United States, of any State, or of any political subdivision of any State; (3) any entity established under the laws of the United States, any State, or any political subdivision of any State, or under an interstate compact, that exercises governmental authority on behalf of the United States, any such State, or any such political subdivision; (4) any entity, other than a bank, whose common stock or analogous equity interests are listed on the New York Stock Exchange, the American Exchange, or the NASDAQ Stock Market (a “listed entity”), provided that, if the listed entity is a financial institution other than a bank, it is an exempt person only to the extent of its domestic operations; (5) any subsidiary, other than a bank, of a listed entity mentioned in the previous item (4) that is organized under the laws of the United States or of any State, provided that the listed entity owns at least 51 percent of the equity interest of the subsidiary, and subject to the qualification that if the subsidiary is a financial institution other than a bank, it is an exempt person only to the extent of its domestic operations; (6) any other commercial enterprise, with certain exceptions, that maintains a transaction account at the bank for at least two months, frequently engages in transactions with the bank in currency in excess of $10,000, and is incorporated or organized under the laws of, or is registered as and eligible to do business within, the United States or a State (a “non-listed business”), but only to the extent of the non-listed business customer's domestic operations and only with respect to transactions conducted through the non-listed business customer's exemptible accounts; or (7) any other person, with certain exceptions, that maintains a transaction account at the bank for at least two months, operates a firm that frequently withdraws more than $10,000 in order to pay its U.S. employees in currency, and is incorporated or organized under the laws of, or is registered as and eligible to do business within, the United States or a State (a “payroll customer”), but solely with respect to withdrawals for payroll purposes from existing exemptible accounts.
31 CFR 1020.315(c)(1) requires a bank to designate an exempt person by filing
31 CFR 1020.315(d) requires a bank to review at least once annually the continued eligibility of an exempt person that is a (1) listed entity, (2) subsidiary of a listed entity, (3) non-listed business customer, or (4) payroll customer. As part of the annual review, a bank must also review the application to each existing account of a non-listed business or payroll customer of the monitoring system that 31 CFR 1020.315(h)(2) requires the bank to maintain (related to suspicious activity monitoring).
Under 31 CFR 1020.315(e), a bank must take steps to assure itself that an exempt person meets the definition of that term (
31 CFR 1020.315(h)(1) states that the CTR exemption rules do not relieve a bank of its obligation to report any suspicious transactions pursuant to 31 CFR 1020.320, including any suspicious transactions or attempted transactions in currency associated with the accounts of an exempt person, or relieve a bank of any other reporting or recordkeeping obligation imposed under the authority of the BSA.
Under 31 CFR 1020.315(h)(2), a bank must establish and maintain a monitoring system that is reasonably designed to detect, for each account of a non-listed business or payroll customer, transactions in currency that would require a bank to file a suspicious activity report.
In Part 1 of this notice, FinCEN describes the distribution of the estimated number of financial institutions, by type, affected by the regulatory requirements. In Part 2, FinCEN proposes for review and comment a renewal of the calculation of the annual PRA burden that includes a scope and methodology similar to that used in the 2021 notice to renew the OMB control number associated with this information collection requirement.
The distribution of financial institutions, by type, covered by this notice is reflected in table 1 below.
In connection with a variety of initiatives FinCEN is undertaking to implement the AML Act, FinCEN intends to conduct, in the future, additional assessments of the PRA burden associated with BSA requirements.
FinCEN continues to estimate the annual hourly burden of the designation of exempt persons as one hour per report. This estimate covers the burden of: (1) reporting, which is estimated to require an average of 45 minutes to fill out and file the report; and (2) recordkeeping and maintenance, which is estimated to require an average of 15 minutes per report. FinCEN believes that the information required to be included on the DOEP Report is basic information that banks need to maintain to conduct business. The BSA E-filing
FinCEN's estimate of the annual PRA burden, which is based on reporting activity in the previous calendar year, therefore, is 15,105 hours, as detailed in table 2 below:
FinCEN is utilizing the same fully loaded composite hourly wage rate of $106.30 utilized in the 2024 notices of proposed rulemaking (NPRMs) entitled Customer Identification Programs for Registered Investment Advisers and Exempt Reporting Companies and Anti-Money Laundering and Countering the Financing of Terrorism Programs, as well as in recent 60-Day Notices to renew OMB control numbers corresponding to specific BSA regulations.
The total estimated cost of the annual PRA burden is $2,421,331.50, as reflected in table 3 below:
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. Records required to be retained under the BSA must be retained for five years.
August 13, 2024, 2:00 p.m. to 5:00 p.m., Eastern time.
This meeting will take place at the Hotel Indigo Traverse City 263 W Grandview Parkway, Traverse City, MI 49684. The meeting will also be accessible via conference call and via Zoom Meeting and Screenshare. Any interested person may call (i) 1-929-205-6099 (US Toll) or 1-669-900-6833 (US Toll), Meeting ID: 962 8943 3049, to listen and participate in this meeting. The website to participate via Zoom Meeting and Screenshare is
This meeting will be open to the public.
The Unified Carrier Registration Plan Enforcement Subcommittee (the “Subcommittee”) will continue its work in developing and implementing the Unified Carrier Registration Plan and Agreement. The subject matter of this meeting will include:
The Subcommittee Chair will welcome attendees, call the meeting to order, call roll for the Subcommittee, confirm whether a quorum is present, and facilitate self-introductions.
The UCR Executive Director will verify the publication of the meeting notice on the UCR website and distribution to the UCR contact list via email followed by the subsequent publication of the notice in the
The Subcommittee Agenda will be reviewed, and the Subcommittee will consider adoption.
Draft minutes from the April 5, 2024, Subcommittee meeting in Savannah, GA will be reviewed. The Subcommittee will consider action to approve.
The Subcommittee Chair will review a variety of tools and activities undertaken in 2024 to conduct enforcement activities in the states.
The Subcommittee Chair will lead a discussion on enforcement limitations in nonparticipating states.
The Subcommittee Chair will lead a discussion on the possibility of roadside enforcement for carriers who have been identified as under-registered.
The Subcommittee Chair will lead a discussion on possible future language suggestions as it relates to the UCR agreement.
The Subcommittee Chair will lead a discussion on the possibility of establishing an annual Inspector award for excellence in UCR Enforcement.
The Subcommittee Chair will lead a discussion of and determine dates for the 2025 UCR Awareness Initiatives.
The Subcommittee Chair will provide an update on the progress of the creation of the enforcement training PowerPoint as an additional resource for Law Enforcement.
The Subcommittee Chair will call for any other items Subcommittee members would like to discuss.
The Subcommittee Chair will adjourn the meeting.
The agenda will be available no later than 5:00 p.m. Eastern time, August 5, 2024 at:
Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783,
August 13, 2024, 10:00 a.m. to 1:00 p.m., Eastern Time.
This meeting will take place at the Hotel Indigo Traverse City 263 W Grandview Parkway, Traverse City, MI 49684. This meeting will also be accessible via conference call and via Zoom Meeting and Screenshare. Any interested person may call (i) 1-929-205-6099 (US Toll) or 1-669-900-6833 (US Toll), Meeting ID: 985 7826 0423, to listen and participate in this meeting. The website to participate via Zoom Meeting and Screenshare is
This meeting will be open to the public.
The Unified Carrier Registration Plan Dispute Resolution Subcommittee (the “Subcommittee”) will conduct a meeting to continue its work in developing and implementing the Unified Carrier Registration Plan and Agreement. The subject matter of this meeting will include:
The Subcommittee Chair will welcome attendees, call the meeting to order, call roll for the Subcommittee, confirm whether a quorum is present, and facilitate self-introductions.
The UCR Executive Director will verify the publication of the meeting notice on the UCR website and
The Subcommittee Agenda will be reviewed, and the Subcommittee will consider adoption.
Draft minutes from the January 25, 2024 Subcommittee meeting will be reviewed. The Subcommittee will consider action to approve.
The UCR Dispute Resolution Subcommittee Chair and UCR Plan Legal Counsel will lead a discussion and review of the current Dispute Resolution Procedure. The document sets forth the current UCR procedure for processing and handling eligible disputes. The document was last amended in January 2024.
The Subcommittee Chair will call for any other items Subcommittee members would like to discuss.
The Subcommittee Chair will adjourn the meeting.
The agenda will be available no later than 5:00 p.m. Eastern time, August 5, 2024, at:
Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783,
Farm Service Agency, USDA.
Final rule; with request for comment.
The Farm Service Agency (FSA) is amending the Farm Loan Programs (FLP) regulations to implement the Distressed Borrower Set-Aside (DBSA) Program and other changes. DBSA will provide a new loan servicing program for financially distressed borrowers that will allow for the deferral of one annual loan installment at a reduced interest rate. DBSA will provide a simpler option to resolve financial distress than existing loan servicing programs. In addition to helping borrowers by adding DBSA as a new loan servicing program, FSA is amending the FLP regulations to revise loan making and servicing to improve program access and delivery. This rule is part of FSA's ongoing efforts for farm loans to remove barriers to capital access and increase opportunities for borrowers to be successful.
We invite you to submit comments on the information collection requirements. You may submit comments by any of the following methods:
•
Comments will be available for viewing online at
Houston Bruck; telephone: (202) 650-7874; email:
FSA makes and services a variety of direct and guaranteed loans to farmers who are unable to obtain commercial credit sufficient to meet their needs at reasonable rates and terms. FSA also provides direct loan borrowers with credit counseling and supervision, to increase the borrowers' chance for success. FSA loan applicants are often:
• beginning farmers (BF) and socially disadvantaged (SDA) farmers who do not meet the underwriting requirements of commercial lenders because of insufficient net worth; or
• established farmers who have suffered financial setbacks due to natural disasters or economic downturns.
FSA loan applicants are also often farmers whose short- and long-term operational and personal goals are not well met by commercial lending products. FSA loans are tailored to a farmer's needs and may be used to buy farmland and to finance agricultural production.
The Consolidated Farm and Rural Development Act (CONACT, Pub. L. 87-128, as amended; 7 U.S.C. 1921-2009cc-18) provides the authority for most FLP loans, including farm ownership, operating, and emergency loans.
After FSA provides a loan to a farmer, FSA continues to work with the borrower to monitor the progress of their operation, provide guidance on budgetary issues, and ensure loan repayment. If FSA loan borrowers become financially distressed and are unable to make loan installments as scheduled, or if the borrowers' plans change requiring reconsideration of original terms, FSA staff work with borrowers to explore options to improve profitability. A common solution to resolving financial distress is providing the distressed loan with more flexible rates or terms to improve profitability. These loan servicing options are commonly referred to as the Primary Loan Servicing Program (PLS) and the Disaster Set-Aside Program (DSA).
Section 22006, Farm Loan Immediate Relief for Borrowers with At-Risk Agricultural Operations, of the Inflation Reduction Act of 2022 (IRA, Pub. L. 117-169) authorized $3.1B in funds for FSA to create and provide certain additional assistance opportunities for distressed farm loan borrowers of FLP loans authorized under the CONACT. To date, FSA has provided historic assistance under IRA Section 22006 to assist distressed borrowers, including 6 different rounds of payments addressing both long-term and immediate sources of distress. To complement PLS, DSA, and previous IRA assistance, FSA is implementing a new loan modification option, the DBSA Program. DBSA is similar to DSA and will provide a new loan servicing option for financially distressed borrowers that will allow for the deferral of one annual loan installment per loan at a reduced interest rate under certain conditions. DBSA has three important distinctions compared to DSA:
• the deferred payment will accrue at a reduced interest rate,
• the loan must have been outstanding as of September 25, 2024, and
• the borrower does not have to suffer a loss from a declared disaster to qualify for DBSA.
This rule implements DBSA and makes other changes as the next step in FSA's ongoing effort to remove barriers to capital access and increase opportunities for borrowers to be successful. The COVID-19 pandemic highlighted the need for FSA to undertake a culture shift in its approach to farm loans to expand virtual opportunities and implement loan processes to improve turnaround times on financial assistance. For example, for loans overall, recent investments in online education and application platforms are making the loan process simpler to navigate virtually, and new underwriting techniques based on financial benchmarking of FSA's portfolio are expediting the loan process.
FSA is also clarifying and amending information throughout the FLP regulations to make it easier for borrowers to understand program requirements. These changes were developed with significant input from employee associations and the gathering of important insights from lending industry partners and agricultural advocacy groups. Advice and recommendations from agricultural advocacy groups on potential program improvements were carefully considered as FSA developed some of the more substantial changes, including improvements to the direct loan security requirements, cash flow budgeting process, and flexible repayment terms offered on direct loans.
While most of the amendments are not substantially altering existing policy, or are anticipated to impact a relatively small number of farmers, some changes are substantial, impacting nearly all direct loan customers, including changes that amend
The CONACT requires that all FLP applicants and loans meet certain requirements related to eligibility, security, and feasibility. The changes in this rule ensure FLP regulations continue to align with the CONACT and better reflect the needs of farmers, industry trends, historical data, and modernization of underwriting standards. Although many of the amendments in this rule are technical corrections or clarifications, there are several changes to FLP policy that better reflect customer needs and modernized standards in the greater agricultural lending industry.
This rule marks the most recent example of FSA's dedication to increase equity, improve customer service, and provide opportunities for customers to maximize their financial success.
Throughout this rule, any reference to “farm” or “farmer” also includes “ranch” or “rancher,” respectively.
This rule is implementing the DBSA Program to assist distressed borrowers whose operations are at financial risk and face the possibility of bankruptcy, liquidation, or foreclosure. Using available funds under section 22006 of IRA, DBSA is a payment deferral program for financially distressed or delinquent borrowers with outstanding direct loans administered under subtitle A (Farm Ownership Loan (FO) Program, Conservation Loan (CL) Program, and Soil and Water Loan (SW) Program), subtitle B (Operating Loan (OL) Program), or subtitle C (Emergency Loan (EM) Program) of the CONACT.
While the DBSA Program will operate similarly to the existing DSA Program, there are important eligibility distinctions. Specifically, deferral under DBSA is only available for eligible direct loans outstanding as of September 25, 2024, and a borrower does not need to have been affected by a declared disaster to qualify. Importantly, and similar to both DSA and PLS eligibility requirements, borrowers requesting DBSA assistance must demonstrate that a set-aside of their current direct loan payment(s) would resolve their financial distress and result in a feasible operating plan.
Payments deferred under DBSA will be repaid at the time of loan maturity and will carry a reduced interest rate of 0.125 percent. This is the lowest interest rate the CONACT authorizes to be applied to loans. The CONACT authorizes the Secretary certain discretion in determining interest rates for the FO, SW, CL, OL, and EM Programs. For FO, CL, SW and OL Programs, the rate must not be in excess of the average yield for Treasury notes with similar maturities to the FO or OL Programs, plus an amount not to exceed 1 percent. The EM Program interest rates determined by the Secretary must be below 8 percent. This reduced interest rate on DBSA:
• is being used to mitigate the adverse impacts of additional interest accrual on the deferred payment for borrowers, and
• increases the likelihood for the long-term success and improves long-term repayment ability of the operation.
DBSA was created in part in response to input from borrowers, FSA staff, and other stakeholders noting that DSA works well to help resolve financial distress without requiring PLS, and that a similar set-aside program would also help many borrowers in financial distress who have not been affected by a natural disaster.
Before this rule, FSA could only offer a deferral on direct loans through PLS or DSA. PLS is different from DBSA because PLS requires a series of loan servicing options to be considered and typically results in the loan being restructured; PLS can also be time consuming for the borrower.
DBSA is expected to be selected by many customers as a viable alternative to DSA and PLS. If a customer does not qualify for a DBSA, for example, if their financial distress cannot be resolved by deferring the current installment to the end of the loan, they may need the more complex loan servicing solutions and formal loan restructuring that is available through PLS.
As a result of the subsidy rate analysis, FSA determined that since the loan modifications costs of DBSA are funded by section 22006 of IRA, that only those loans that are outstanding as of September 25, 2024, which is the effective date of this rule, will be eligible. The rationale for that is to comply with the statutory authority as FSA paid for the loan modification costs up front based on the current loan portfolio. Borrowers may request DBSA on those loans at any time over the loan period, but may only have 1 DBSA outstanding per loan.
DBSA will provide existing FSA direct loan borrowers who are financially distressed or delinquent with an option to request a one-time deferral of a delinquent or upcoming annual installment instead of using PLS or DSA to address loan repayment issues. A delinquent borrower is defined in 7 CFR 761.2(b) as “a borrower who has failed to make all scheduled payments by the due date,” and a financially distressed borrower is defined as “a borrower unable to develop a feasible plan for the current or next production cycle.” The amount of the deferral will be limited to the lesser of the amount of the annual installment or the unpaid balance remaining on the installment at the time the DBSA is approved. The deferred amount will have a reduced interest rate of 0.125 percent. The amount deferred, plus interest, will be due at the end of the loan term.
To request DBSA, borrowers must submit a request for DBSA in writing to FSA. The borrower will be required to submit actual production, income, and expense records for the current production cycle, and an operating plan for the upcoming production cycle, unless FSA already has that information on file for the borrower. This information will be analyzed by FSA to validate that a profitable cash flow budget for the current production cycle cannot be developed without deferring the next loan installment due on their outstanding FLP loans. FSA will notify the borrower in writing within 30 days if their request for DBSA is approved or denied, and the borrower must provide required DBSA closing documents within 45 days of approval notification.
DBSA will be implemented in a new subpart J of part 766, with conforming changes in parts 761, 765, and 766.
In addition to helping borrowers by adding DBSA as a new loan servicing program, throughout the FLP regulations FSA is making discretionary changes to clarify and amend existing delivery processes and program requirements to increase access to FLP,
The rule is making clarifications, which are in response to input from borrowers, staff, and other stakeholders. FSA has determined that clarifying the information in the regulation will make it easier for borrowers to understand program requirements. These clarifying amendments do not constitute a change in policy. The specific changes are discussed later in this document. Specifically, this rule clarifies:
• the definitions in 7 CFR 761.2 of Agricultural Commodity, Family Farm, Feasible Plan, Good Faith, Non-Eligible Enterprise, Participated in the Business Operations of a Farm, Related by Blood or Marriage, Relative, and Youth Loan;
• the financial analysis and document submission requirements for existing borrowers in 7 CFR 761.105 and 765.101;
• copies of real estate and equipment leases are required as part of a complete direct loan making or servicing application upon request in 7 CFR 764.51 and 766.102;
• the requirements in 7 CFR 764.51 and 764.101 to determine reasonableness of available credit elsewhere;
• direct loan eligibility credit history requirements in 7 CFR 764.101 apply to all entity members;
• guaranteed loan eligibility credit history requirements in 7 CFR 762.120 when there is previous debt forgiveness;
• the general direct loan managerial eligibility requirement in 7 CFR 764.101 and aligns it with the direct FO requirement;
• the EM requirements in 7 CFR 764.353 to ensure duplicate benefits are not provided;
• the special interest rate for beginning and veteran farmers obtaining a direct Microloan (ML)-OL in 7 CFR 764.254 and for the Indian Tribal Land Acquisition Program (ITLAP) 7 CFR 770.6;
• the application, eligibility, and loan security requirements for transfer and assumption requests in 7 CFR 765.402, 765.403 and 765.404; and
• equitable relief provisions in 7 CFR 768.1.
In addition to the clarifying amendments, FSA is making technical corrections to existing regulatory requirements that do not constitute a change in policy. Specifically, this rule corrects minor grammatical or typographical errors throughout 7 CFR 761 to 769, including correcting both “writedown” and “write down” to “write-down.”
The majority of amendments in the rule are changes in policy, most of which are non-substantial changes to existing regulatory requirements. Those amendments that are policy changes, but considered non-substantial in nature, include:
• in 7 CFR 761.2, revising the “family farm” definition to include commercial foraging operations for the purposes of operating loan assistance where commodities are foraged on Indian land, and adding definitions for “commercially foraged”, “Indian land” and “Indian Tribe;”
• requiring all guaranteed lenders to receive FSA approval of a transfer and assumption to ensure applicants satisfy eligibility requirements in 7 CFR 762.142;
• authorizing subordinations of loan security for a guaranteed lender to refinance its own debt in 7 CFR 762.142;
• removing borrower production training requirements throughout 7 CFR part 764 that are often waived, but maintaining the important borrower financial training requirements;
• authorizing direct OL security to be a junior lien on real estate in 7 CFR 764.251 when the purpose of the loan is to finance minor real estate repairs or improvements, and establishing lease terms for those circumstances;
• increasing the direct youth operating loan limit in 7 CFR 764.303 from $5,000 to $10,000;
• the experience eligibility requirements for direct FOs in 7 CFR 764.152;
• changing the EM formula for production loss used for determining the EM amount in 7 CFR 764.352;
• in 7 CFR 765.102, allowing direct loans that are only in non-monetary default for failure of the borrower to comply with graduation requirements to be converted to non-program loans instead of FSA proceeding with foreclosure action;
• providing specific response timeframes and FSA notification requirements for direct loan subordination requests in 7 CFR 765.205;
• changing the requirements in 7 CFR 765.252 for the lease of FSA security to provide borrowers additional flexibility;
• in 7 CFR 765.352 authorizing a portion of the proceeds from the sale of loan security to be retained by the borrower to pay capital gains taxes;
• establishing a State Executive Director's authority to extend PLS application deadlines in extraordinary circumstances in 7 CFR 766.101;
• expanding reasons that a delinquency may be due to circumstances beyond the control of a borrower for the purposes of PLS in 7 CFR 766.104 to include catastrophic medical expenses for the care of family member of a borrower or entity member;
• establishing timeframes in 7 CFR 766.115 for a borrower to obtain an independent appraisal if they dispute an FSA appraisal;
• making minor adjustments and edits to the form for the Notice of Availability of Loan Servicing to Borrowers Who Are 90 Days Past Due in 7 CFR 766, Subpart C, Appendix A (form FSA-2510) and the related form for Iowa in Appendix B, to reflect the changes implemented in this rule and make minor technical corrections (the changes are not intended to change the information being collected); and
• making changes in 7 CFR 769 to the Heirs' Property Relending Program (HPRP), including expanding the application period.
The most substantial changes to the Farm Loan Programs regulations are those that apply to all borrowers and are intended to promote profitable farming operations. These changes will be incorporated into the subsidy rate for the relevant loan programs per FCRA. Specifically, this rule:
• establishes requirements for the development of farm operating plans and farm assessments in 7 CFR 761.103, 761.104, and 762.124, to ensure consideration of a reasonable amount of cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education;
• provides all eligible applicants the option to receive flexible repayment terms, including maximum direct loan repayment terms and an option for interest-only payments during the first year for certain types of direct loans in 7 CFR 764.154, 764.254, and 764.354;
• modifies direct FO, OL, and EM additional loan security requirements in 7 CFR 764.103, 764.106, 766.56, and
• adds 7 CFR 766.120, which provides an alternative to PLS, allowing for a simplified extension of repayment terms when a balloon payment comes due; and
• expands opportunities in 7 CFR 765.305 and 765.351 for the release of a limited amount of direct loan security without compensation in certain circumstances.
The following discussion provides additional detail on the amendments identified as substantial changes. Below that, non-substantial changes, clarifications, and technical corrections are discussed, in that order.
Developing a reasonable farm operating plan is essential for a farming operation to be successful. An important component of developing a farm operating plan includes considering the amount of reserves and cash flow margin necessary to support operational stability and growth. This will benefit farmers by providing the opportunity to create farm operating plans with budgets that include a reasonable amount of cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education. This rule amends 7 CFR 761.103 and 761.104(f) to provide opportunity for FSA's farm assessments and borrowers' farm operating plans to allow for savings to support long-term operational financial stability and growth, including savings to ensure personal financial stability. Amendments to 7 CFR 761.103 also build consideration of borrowers' short- and long-term goals for their operation into annual farm assessments, as required by the CONACT, including progress towards graduation to commercial credit or eventual self-financing. This encourages farmers to consider customized FSA loan repayment terms that may better meet the goals of their proposed farming plan, including equal, unequal, interest-only, and balloon payments, as part of developing that plan. This rule amends 7 CFR 762.124 to clarify that flexible repayment terms may also be necessary to support guaranteed loan customers.
Farm operating plans that are unable to adequately fund working capital reserves and savings often indicate financial distress, which can lead to the need for additional loans or for FSA to provide loan servicing options. Flexible repayment terms help to ensure that adequate working capital reserves and savings are available for investments as opportunities arise. Through the promotion of flexible repayment terms, FSA is providing the best terms available to a borrower up front that maximize the opportunity to achieve adequate reserves and savings, as opposed to waiting for the operation to become distressed under the weight of excessive debt service obligations before a loan can be restructured with reduced payment requirements. Rather than the traditional approach of equity growth through accelerated debt repayment, flexible repayment terms support borrower equity growth by allowing borrowers the freedom to accumulate working capital reserves to make strategic investments in a timely manner, resulting in substantially more equity growth than would otherwise be realized through accelerated debt repayment.
The maximum repayment term for direct loans is 40 years for an FO and 7 years for an OL. Determining the appropriate repayment term within those limits has historically required FSA to apply its discretion based on an individualized analysis of the applicant's ability to repay and the useful life of the security, which can result in inconsistency in the terms offered to applicants. This rule will standardize all repayment schedules offered to applicants to provide a greater opportunity to build operational stability and be successful. Updates to 7 CFR 764.154(b)(1), 764.254(b)(2), 764.354(b)(4) and (5) require all FOs, OLs, and EMs for purposes other than family living and farm operating expenses, to be scheduled over a term equal to the lesser of the useful life of security or the maximum term authorized by law, unless the applicant otherwise requests a shorter term in writing. This rule does not affect the repayment term provided on Down Payment Loans, which is established by the CONACT to be 20 years or less. FSA will continue to offer Down Payment Loans to customers with a repayment term of 20 years unless the applicant desires a shorter term to be considered.
Additionally, this rule amends the standard repayment term for the ML-FO Program. FSA developed ML to better serve the unique financial operating needs of new, niche, and small family farm operations. MLs offer more relaxed application requirements and serve as an attractive loan option, particularly for smaller and non-traditional farm operations that often face limited financing options.
While there is no difference between the maximum repayment term for an OL or an ML-OL (7 years), the ML-FO has been limited by regulation to a 25-year maximum repayment term, substantially less than the 40-year term of an FO. Since the ML-FO is targeted to small, start-up, and niche farming operations, the more restricted repayment term may put additional financial constraint on applicants who may already have limited financial resources. This rule amends 7 CFR 764.154(b) to allow for a maximum repayment term of 40 years for an ML-FO. Should a ML-FO applicant determine it to be in their best interest to receive a loan term less than 40 years, for example, to benefit from paying less total interest over the life of their loan, the applicant may request a shorter term in writing. Additionally, borrowers may reduce their interest cost over the life of a loan by making additional payments if they are able and desire to do so as FSA loans carry no pre-payment penalty.
In addition, FSA emphasizes the use of flexible repayment terms to ensure adequate working capital reserves and savings can be accumulated by the borrower. As mentioned above, to ensure all borrowers have an opportunity to grow adequate working capital reserves and savings, all applicants will be offered an opportunity for a repayment plan on new term loan requests that includes an interest-only installment during the first year of the loan. An interest-only installment the first year of a loan can result in a substantial boost to reserves and savings, enabling the borrower to make strategic investments to grow their operation without having to take on additional debt. For borrowers who elect the first-year interest-only installment plan, principal reduction will typically begin after the sale of crops or livestock produced during the second year of the loan. This rule makes these changes in 7 CFR 764.154(b)(2) and (3), 764.254(b)(3) and (4), and 764.354(b)(6) and (7).
Prior to this rule, FSA structured most loans using equally amortized
Providing the option of flexible repayment terms at the time of loan approval enables all borrowers to receive the benefits of a deferral of principal without having to first become financially distressed or defaulting on their loan in order to access the loan servicing options of PLS, DBSA, or DSA. Providing more flexible repayment terms allows borrowers to make timely and strategic investments to grow their operations. As specified above, flexible repayment terms have the potential to reduce program delinquency and will provide borrowers with more options to meet the short- and long-term goals of the farm business, and to generate reasonable working capital reserves and savings, including savings for retirement and education.
For loans with balloon installments scheduled, borrowers have been required to go through the process of applying for PLS to extend the repayment schedule of their loan. This process is not customer-friendly and makes little sense for a borrower who has repaid as agreed throughout the initial loan term. Accordingly, this rule adds 7 CFR 766.120 to enable a borrower to receive a simple extension of repayment terms for up to an additional 8 years from the date the balloon payment comes due. This will provide the borrower with repayment terms similar to what they would receive through PLS, but without needing to go through the PLS process. Under PLS, an operating loan can be rescheduled for a term up to 15 years. Accordingly, this option aligns with that PLS provision by permitting an extension of up to 8 years for repayment of the ballooning loan where the original maturity date was no more than 7 years from the date of loan closing.
To ensure this option is adequate to meet the borrower's needs, it is available only to borrowers who have a history of successful repayment of their loans, including making full installments for the last 3 years on the ballooning loan. For other borrowers, PLS will continue to be available. Additionally, this option is not available on loans where repayment terms have already been altered by PLS, or that have an outstanding DSA or DBSA, as the terms of those updated repayment agreements cannot be accommodated with a basic extension of the original loan terms.
This rule amends additional direct loan security and collateral servicing requirements to better enable borrowers to leverage assets and make strategic investments in their operations. This rule does not amend guaranteed loan security requirements. Additional loan security is collateral in excess of what is needed to fully secure the loan. Specifically:
• Additional direct loan security requirements in 7 CFR 764.103(c) requires a 125 percent loan security margin when available for direct loans, which is a change from the current requirement of 150 percent. The amendment also requires that real estate assets only be provided as additional security for direct FOs. Consistent with the current regulation and policy, if the borrower does not have the additional security available to pledge, FSA may still be able to make the direct loan if the loan is fully secured; additional security will only be taken “when available.”
• This rule also amends 7 CFR 764.103(c) to expand the circumstances in which no additional security is required, to now include all Microloans and FOs for which a cash down payment has been provided (similar to the existing Down Payment Loan Program, which does not require additional security).
• This rule removes direct loan making requirements for a personal residence to be used as additional security for direct loans in 7 CFR 764.106(d) under certain conditions.
• The reduced additional security requirement of 125 percent security margin, where available, is also being applied to PLS in 7 CFR 766.112(a); however, a lien on the personal residence will still be required during PLS if necessary to achieve a 125 percent security margin.
• This rule also amends the DSA additional security requirement by removing 7 CFR 766.56 so that additional security will not be required to be pledged if a customer requires DSA Program assistance, consistent with the new DBSA Program.
• This rule removes a requirement in 7 CFR 762.145(b)(7) that required guaranteed lenders to take a lien on all assets when restructuring a loan with a balloon installment.
• This rule provides processes for an expedited release of certain direct loan security in 7 CFR 765.305(c) and 765.351(f) after a period of successful loan repayment, further promoting borrower growth and saving significant staff time monitoring loan security that is not essential to loan repayment.
These fiscally responsible data-driven changes ensure that FSA is not overcollateralized and allows borrowers to leverage the equity in their assets to grow their operations. Since 1994, the regulation has required direct loans to be secured by not only the assets purchased or improved with loan funds, but also an additional amount of security equal to 50 percent of the direct loan amount, if available. FSA determined that this requirement created a significant cost in both time and resources to perfect a lien on additional property, which has been determined to not be necessary for FSA to be fully secured, and also constrained borrowers from using equity to acquire capital needed for expansion for other business purposes.
A lien on assets purchased or improved with direct loan funds will still be required to provide adequate security for FSA farm loans. However, FSA recognizes that excessive additional security requirements that are unnecessary to significantly mitigate losses to the Government can ultimately restrict a borrower's ability to grow their operation by accessing asset equity. While this rule removes certain additional security provisions where FSA has determined taxpayer resources
Revising the direct loan security margin in 7 CFR 764.103(c) to 125 percent, reduces the amount of additional security required for a direct loan by half, from 50 percent of the loan amount down to 25 percent. FSA has determined that security at least equal to 125 percent of the loan amount, where available, will provide adequate assurance of repayment. In fact, since fiscal year (FY) 2000, the average security margin for loans that experienced a loss was 120 percent at the time the loan was made, which is below the revised threshold. Accordingly, this revised amount of additional security aligns not only with historic portfolio performance data, but also with the loan security expectations by other government lending regulators. Furthermore, in the infrequent situation where FSA does liquidate security (approximately 4.1 percent of all accounts since FY 2000), the average administrative cost to FSA is less than 10 percent of the security value. This is substantially below the 25 percent additional security amount required in this rule, which provides an amount sufficient to cover estimated FSA administrative costs in the majority of liquidation circumstances. The requirement for additional security can be particularly important to protect the government from program losses for higher-risk direct OLs where primary security is often crops, livestock, or equipment with security values that are more volatile than real estate. However, for direct loans where real estate serves as adequate security, such as FOs, the additional security provision can result in FSA initially requiring more security than is necessary to protect the government's interests.
Prior to this rule, FSA perfected additional security lien interests on short-term non-real estate security items such as crops, livestock, and equipment, even if the loan was secured by more robust forms of collateral—such as real estate—as in the case of an FO. Requiring a lien on short-term assets for long-term debt significantly hinders a borrower's ability to leverage those assets to obtain reasonable rates and terms through commercial lenders for operating purposes, thereby delaying graduation to commercial credit or making progress towards self-financing, which are primary FLP objectives.
For FSA direct loans, additional non-real estate security assets are rarely relied upon for repayment of debt primarily secured by real estate, even in cases of foreclosure. The FSA data show losses on direct real estate loans are reduced when the loan-to-value at the time of liquidation is below 95 percent, as demonstrated in the Down Payment Loan Program. In the Down Payment Loan Program, applicants are required to provide a 5 percent cash down payment, and additional security is not required to be pledged. The FSA Down Payment Loan Program has an average historical loss rate from 2000 through 2023 of less than 0.14 percent, which is significantly lower than the average FO Program loss rate of 0.96 percent. This further demonstrates that additional security is generally unnecessary for successful repayment of real estate debts when even a small amount of equity exists in the real property security.
Accordingly, this rule changes the additional security required for direct FOs to only be other real property. As discussed, when a loan is secured by real estate it is rare that FSA would rely on non-real estate assets to avoid a loss. This change to 7 CFR 764.103(c) will improve FSA internal processes by removing the need for FSA staff to maintain security interests that are unnecessary to adequately safeguard taxpayer resources, saving the time and cost of security inspections, and allowing borrowers to leverage asset equity to improve their operation.
This rule extends the list of existing exemptions from additional security requirements in 7 CFR 764.103(c) to include any direct FO where the applicant supplies a 5 percent cash down payment of the purchase price. This exemption has historically been available only for the Down Payment Loan Program, where the CONACT limits the security required. As discussed, the Down Payment Loan Program was a significant success, with the lowest delinquency and loss rate of any current FLP loan. Where a similar down payment is provided by an applicant of a regular FO, FSA expects similar low delinquency and loss rates. This expanded exemption will provide increased incentive for applicants to provide a cash down payment that improves the FSA security position without additional security needing to be pledged by the applicant.
This rule further extends the list of existing exemptions from additional security requirements in 7 CFR 764.103(c) to include any ML. This exemption will improve access to MLs, which are predominantly made to small and beginning farmers. Prior to this rule, only term MLs (such as direct loans for equipment or real estate purchases) were exempt from additional security requirements. This rule extends the exemption to any ML, including those for annual operating expenses. The average ML delinquency rates for 2017 through 2021 (13 percent for operating ML-OL and 3.6 percent for ML-FO) are approximately half that of their regular OL or FO counterparts. The annual ML-OL delinquency rate is also approximately 5 percent lower than the regular annual OL delinquency rate. Overall, the ML Program has a solid history of stronger repayment performance compared to most other farm loan programs. ML historical performance supports that program integrity can be maintained while extending the additional security exemption to all MLs.
This rule specifies in 7 CFR 764.106(d) that the personal residence will not be required for direct loans provided that the loan is fully secured by assets that have a value equal to the loan amount and the residence is on no more than 10 acres or the minimum amount able to be parceled into a separate legal lot. Reducing the frequency of personal residences to serve as additional security improves a borrower's ability to provide for basic housing needs in the event of financial distress. FSA has rarely relied on equity in a borrower's home pledged as additional security to ensure repayment, even in situations of distress. However, a lien on the personal residence will be required should the borrower ultimately require PLS.
Additionally, the rule applies the revised direct loan making security levels to the servicing of the loan by requiring additional security of up to 25 percent of the loan amount to be taken as a requirement of PLS, which is a reduction from the existing requirement for a lien on all assets. These changes in 7 CFR 766.112(a) will result in improved program delivery by reducing the administrative burden of maintaining and tracking unnecessary additional security as noted above, while furthering program objectives by improving the prospects of borrower graduation as borrowers are able to leverage asset equity to accelerate financial growth. Historical portfolio performance data reflect that the average security margin on accounts that
This rule removes 7 CFR 766.56, which previously required that borrowers provide a lien on all assets in order to receive DSA. All loans are originally made with adequate security to fully secure the FSA debt, so the requirement for a lien on all assets typically results in the FSA debt being more than adequately secured, which may prohibit the borrower from leveraging equity in assets, or preventing the sale of assets, if necessary to fully recover from a disaster.
A similar requirement in 7 CFR 762.145(b)(7) is also being removed that previously required a lien to be taken on all assets by a guaranteed lender when restructuring a loan with a balloon installment.
The regulations in 7 CFR 765.305 specify the conditions that must be met for FSA to release its security interest. The regulations in 7 CFR 765.351 specify that the borrower must obtain prior consent from FSA for any transactions affecting the real estate security, including when a borrower sells, exchanges, or requests a partial release of security. FSA has historically authorized the release of a limited amount of security without compensation in limited circumstances.
This rule is amending 7 CFR 765.305(c) and 765.351(f) to allow a borrower to receive a lien release of certain security items if they have a demonstrated history of making all payments as scheduled with FSA for the previous 36 months and the loan will be adequately secured after the release. Unencumbering security in excess of 125 percent of the outstanding loan balance allows the borrower to sell the property and improve the borrower's cash position, make the asset available to pledge as collateral for other loans or purposes, or allow the borrower to leverage equity attributed to the a rise in the appraised value of the asset for other investments. In order to provide greater flexibility to borrowers, FSA is removing the requirement that the borrower retain the security and use it as collateral for other credit; however, the transaction must still enhance the program objectives of the FLP loan under 7 CFR 765.301(f) and 765.351(a)(1). A borrower who has made timely payments over the most recent 36 months demonstrates a likely ability to meet scheduled loan payments going forward. Data from FY 2000 to 2023 reflect that accounts with a recorded loss were in financial distress within the first 3 years of loan closing 76 percent of the time. Accordingly, while this policy change may result in an increase in losses, all FSA loans will remain fully secured even after a partial release, and historical data reflect that the vast majority of the time a customer who successfully repays for 3 consecutive years does not incur a loss to the government. The release of security in excess of 125 percent of the outstanding FSA loan balance, will support a borrower's ability to grow their operation by accessing asset equity and will also save significant staff time maintaining liens on assets that are not needed to adequately safeguard taxpayer resources.
The following discussion provides additional detail on the amendments identified as non-substantial changes.
This rule revises the definition of “Family farm” in 7 CFR 761.2(b) to include commercial foraging operations as an eligible family farm for the purposes of operating loans where commodities are commercially foraged on Indian land. This rule adds corresponding definitions for “commercially foraged”, “Indian land” and “Indian Tribe.” While the commercial foraging space has limited participation nationwide, the industry has unique cultural relevance in certain regions. For example, commercial foraging is an important aspect of several Native American Tribal cultures, with a rich history stretching back for generations. Foraging is often done on Indian land managed by an Indian American Tribe. Opening FLP assistance to these operators is a significant step in supporting USDA's commitment and trust responsibility to federally recognized Tribes. While assistance is not limited only to Native American producers, applicants that commercially forage must comply with all local rules and regulations pertaining to foraging on Indian land. The new definitions of “Indian land” and “Indian Tribe” are only used for the commercial foraging provisions established in this rule, and are based on existing definitions of “Indian land” and “Indian Tribe” used in Federal programs to cover commercial foraging on lands owned by an Indian Tribe, restricted fee land owned by an Indian Tribe, and land held in trust for an Indian Tribe. The definition of “Indian land” excludes land held in trust for or owned by individuals.
FSA may subordinate its security interest on a direct loan for many purposes, including when a new guaranteed loan is being considered to refinance the debt of another lender. When the lender requesting the guarantee is limited only to refinancing the debt of another lender, and not its own non-guaranteed debt, the lender faces the risk of the borrower going to a different lender to refinance the non-guaranteed debt of the current guaranteed lender. The new lender could then apply for an FSA guarantee and a subordination of the direct loan, while the existing lender will lose its borrower. This amendment to 7 CFR 762.142(c) allows a subordination of direct loan debt when a lender requests a guarantee on a loan to refinance any debt, including its own.
Similarly, FSA may allow a lender to subordinate its interest in basic security which secures a guaranteed loan in cases in which the subordination is required to allow another lender to refinance an existing prior lien. When the lender requesting the refinance is limited only to refinancing the existing debt of another lender, and not its own debt, the lender faces the risk of the borrower going to a different lender to refinance the debt. The existing lender will lose its borrower, while the new lender will be granted the subordination on the guaranteed loan debt. This rule allows a subordination of guaranteed loan debt when a lender requests to refinance any debt, including its own.
Standard Eligible Lender and Certified Lender Program lenders are required to obtain FSA concurrence to process a transfer and assumption of a guaranteed loan. This rule amends 7 CFR 762.142(d) to require Preferred Lender Program lenders to also obtain FSA concurrence to ensure transferee eligibility and ensure that FSA records accurately reflect the transferee as operator and debtor.
Section 359 of the CONACT requires the educational training needs of each direct loan applicant to be evaluated, with training options provided when needed. Under this authority, FSA evaluates the need of each direct loan applicant to complete borrower training. The borrower then contracts with an approved third-party vendor to provide the training deemed necessary by FSA. This is an important component of FSA's process for granting direct FLP assistance and is consistent with FSA's focus on progression lending.
While borrower financial training has ample training vendors available, and has been essential to the success of many producers, borrower production training options are limited, and efforts to improve borrower production knowledge via mandated training courses are generally ineffective. While most financial training concepts are applicable across all farm types and regions, applicable production training material is specific to agricultural regions and enterprises. There is a substantial lack of vendors providing production training because most organizations that request FSA approval to be an authorized training vendor lack the effective resources to provide production training specific to the varied regions and enterprises. Due to a lack of viable industry-specific production training vendors, FSA provides nearly all direct loan customers a waiver of production training requirements, with less than 5 percent of direct loan customers required to complete borrower production training.
While borrower production training lacks authorized vendors and is generally ineffective at improving borrower production knowledge, private mentorships and relationships built by the borrower themselves are typically the most beneficial production training a producer receives. Therefore, this rule removes all references to borrower production training in 7 CFR 764. However, borrower financial training requirements remain unchanged.
FSA uses direct OL funds to finance minor real estate repairs or improvements, provided the loan can be repaid within 7 years. Construction or improvements amortized over periods longer than 7 years generally align better with direct FO purposes and are not financed with direct OL funds.
While smaller repairs or improvements can be financed by either an OL or FO, an applicant may find it beneficial to apply for an OL in certain instances, such as when FO funds are limited, or when an applicant has reached FO term limits. However, security requirements vary slightly for an FO and OL.
For any OL, security must be a first lien on assets purchased or improved with direct loan funds, while an FO may be secured by real estate in a junior lien position. FSA is amending the OL security requirements in 7 CFR 764.255 for loans where the purpose is to make minor repairs or improvements to allow a lien in junior lien position to serve as adequate security.
In 7 CFR 764.251(a)(11), FSA is requiring that for improvements on leased property, the lease must allow the borrower full use of the improvement over the life of the security or have a provision compensating the borrower for any remaining economic life in the event the lease is terminated.
This rule is amending 7 CFR 764.303(b) to allow FSA to double the direct Youth Loan (YL) limit on the total principal balance owed by an applicant on all YLs at any one time from $5,000 to $10,000. FSA makes direct loans to applicants 10 through 20 years old to finance income-producing projects of modest size in connection with their participation in 4-H, Future Farmers of America (FFA), Tribal youth groups, or similar agricultural youth organizations. The project being financed with an FSA YL provides an opportunity for the young person to acquire experience and education in agriculture-related skills.
YL application activity has steadily fallen in recent years, with YL applications totaling 3,795 in FY 2017, 3,201 in FY 2018, 2,788 in FY 2019, 2,451 in FY 2020, 1,568 in FY 2021, and 1,370 in FY 2022.
An important factor affecting decreased application activity for YL is the relatively small maximum outstanding loan limit of $5,000 per individual. The $5,000 limit has been unchanged since 1988, without adjustment for the significant inflation since that time. The rate of inflation of agricultural inputs is considered to be approximately equal to the Consumer Price Index (CPI). CPI figures indicate that the buying power of $5,000 in 1988 equals more than $10,000 today. The $5,000 loan limit is often not adequate to provide the young person enough to finance their intended projects. During FY 2017 through 2022, the average amount requested per YL applicant was $4,578, which supports the need for this increase above the previous $5,000 limitation.
As specified in the CONACT, one of the eligibility requirements for direct FOs is that an applicant must have participated in the business operations of a farm or ranch, or possess other adequate experience as determined by the Secretary. In the rule published March 9, 2022, (87 FR 13117-13127) that implemented provisions of the 2018 Farm Bill, FSA provided eight specific areas of experience that may be allowed as substitutes for 2 of the 3 years of actual experience. In some combinations, the experiences may meet the requirement for all 3 years.
FSA amends 7 CFR 764.152(d) to require that in the case of an entity, at least one member who will be the operator of the farm must meet these experience requirements. Prior to this rule, the majority of entity members needed to meet the experience requirement, which can limit participation for certain entities whose membership includes individuals with minimal actual farming experience. This amendment expands credit opportunities for applicants.
The EM Program is triggered when a qualifying disaster or emergency is designated by the Secretary of Agriculture or declared by the President. These direct loans help producers recover from disaster-related physical and production losses.
The maximum amount FSA is able to lend for a production loss EM is determined according to 7 CFR 764.353(c); it is determined in part by reducing the calculated production loss by any compensation or insurance payments related to the disaster. This reduction is required so that the applicant will not receive duplicate payments from both an EM and Federal Crop Insurance indemnity payment, or other government payment, as stated in 7 CFR 764.352(k).
In recent years, the USDA Risk Management Agency's Revenue Protection policies have become more popular, and many Federal crop insurance policies sold today provide some form of revenue protection. Revenue Protection policies insure producers against certain yield losses, as well as against revenue losses caused by a reduction in the harvest price compared to a projected price.
Indemnity payments triggered by a Revenue Protection policy do not differentiate between the amount of the payment generated from production or price loss. Since FSA is unable to provide duplicate Federal benefits due to crop losses under 7 CFR 764.352(k) and 42 U.S.C. 5155, this rule amends 7 CFR 764.353(c)(4) to clarify that any compensation or insurance indemnities related to the loss will be subtracted in the calculations to arrive at FSA's maximum EM production loss loan amount.
Prior to this rule, producers who suffered a production loss but were made whole by a Revenue Protection insurance policy could still qualify for an EM since only specific disaster-related insurance payments were reduced. Now, any insurance indemnity payments are deducted from the formula to determine the EM amount, thereby better protecting against duplicate payments.
This rule amends the production loss threshold necessary to qualify for the EM Program in 7 CFR 764.352(h) to allow EM eligibility if a producer sustains a disaster yield that is below the normal production yield of the crop. By default, the CONACT provides eligibility for EMs based on production losses if an applicant has sustained at least a 30 percent production loss. However, the CONACT provides the Secretary discretion to set a lesser percent of production loss as the threshold for eligibility. The production loss threshold has historically been set at the maximum 30 percent threshold, which can prohibit producers from accessing EM assistance necessary to adequately recover from a disaster. FSA is removing the 30 percent threshold such that to qualify for EM assistance the disaster yield must have simply been below the normal production yield of the crop. This change will expand EM opportunities for customers who have a demonstrated loss and are in a financially vulnerable position. Establishing a specific threshold restricts the opportunities for recovery aid, and thus it is reasonable to expand potential program benefits to any eligible producer who has suffered a demonstrated production loss as a result of the declared disaster. FSA notes that the 7 CFR 764.353(b)(3) limitation remains in place that ensures loan amounts do not exceed 100 percent of the total actual production loss sustained by the applicant.
An existing direct loan borrower must refinance their direct loans with a commercial lender at reasonable rates and terms when they have the financial ability to do so. Failure to graduate to commercial credit is considered non-monetary default and the account is referred for acceleration and foreclosure action. While these cases are not frequent, with only 68 instances since FY 2010, final action on these accelerated, non-monetary default loans to full foreclosure and loan settlement is often delayed for years. In these cases, during that delay, the farm loan borrower continues to receive the excess benefit which they are no longer qualified for. For example, the borrower continues to receive a reduced interest rate by not refinancing, even though the financial review reflects that refinancing is an option. As an alternative to non-monetary foreclosure on accounts that would otherwise be in good standing, this rule amends 7 CFR 765.102 to provide for accounts to be converted to non-program status if the borrower fails to comply with graduation requirements or to submit requested financial documents necessary to evaluate a borrower's ability to graduate. Conversion of such loans to non-program status with higher interest rates and restrictive loan terms ensures appropriate use of taxpayer resources, with subsidized program loan benefits being provided only to borrowers in compliance with program requirements. This rule is applicable to all future accounts as it requires a borrower to acknowledge this alternative as a condition of the FSA direct loan. For existing customers to take advantage of this provision, they must acknowledge and accept the conditions separately.
FSA has a clearly defined process for direct loan making and special servicing applications to provide an applicant written notice if additional information is required to make an application complete. A complete subordination application request also includes multiple documents, and borrowers need to be afforded the same opportunity to be notified of any outstanding information necessary to have a subordination request processed. This rule amends 7 CFR 765.205(b) to specify that FSA will process incomplete subordination requests in the same manner as is required for incomplete direct loan making requests.
The lease of non-real estate security can often be in the best interest of FSA. For example, an apiary with beehives that serve as security may desire to lease beehives to other farms for pollination purposes, thereby generating income to ensure success of the operator with minimal deterioration to the security. This rule amends 7 CFR 765.252(c) to allow the lease of non-real estate security in certain situations that are in the best interest of FSA.
Additionally, the regulation in 7 CFR 765.252(a) requires borrowers to obtain approval to lease the surface of real estate security. In August 2021, this provision was amended to limit leases for nonfarm enterprises. This rule amends the wording in 7 CFR 765.252(a)(4) to correctly reference “significant acreage of the security.” Consent is only required for surface leases on the portions of a farm operation that serve as FSA security.
When borrowers sell basic security, they are often subject to capital gains taxes. FSA does not allow proceeds from the sale of basic security to be used for family living or farm operating expenses, which leaves borrowers with limited options to pay capital gains taxes. While historic exception requests for this purpose have been limited, with less than three requests typically made each year, this can be a significant hardship for borrowers with limited financial means to cover the taxes. This rule adds 7 CFR 765.352(a)(4) to allow a borrower to use a portion of proceeds from the sale of basic security to pay capital gains taxes in limited circumstances. Specifically, retention of a portion of proceeds necessary to pay capital gains taxes will only be authorized if the FSA debt remains fully secured and the borrower is not otherwise able to adequately cover the tax liability through reasonable means or obtain non-FSA credit to cover the amount of the taxes.
The 2018 Farm Bill amended section 331D of the CONACT to permit State Executive Directors to extend the 60-day PLS application deadline in extraordinary circumstances. This flexibility is added to the regulation in 7 CFR 766.101(e).
The rule amends 7 CFR 766.104(a)(1)(vi) to add catastrophic medical expenses for a family member in the household of a borrower or entity member, in the case of an entity borrower, as circumstances beyond the control of the borrower leading to delinquency or financial distress for the purposes of PLS eligibility.
Borrowers requesting PLS who do not agree with the FSA appraisal are provided the opportunity to appeal the valuation by submitting their own independent appraisal. This rule amends 7 CFR 766.115(a) to establish a deadline of 90 days for the borrower to obtain and submit an independent appraisal to FSA. FSA has extensive experience in coordinating, contracting, and obtaining a completed agricultural real estate appraisal, with the process traditionally taking anywhere from 30 to 60 days. Accordingly, 90 days is a reasonable amount of time for a borrower to obtain a new valuation and this amount of time ensures that all servicing appeal requests are processed timely.
FSA will provide, by certified mail, the PLS notice to borrowers who are at least 90 days past due; this notice is included in the regulation as required by the CONACT, section 331D (7 U.S.C. 1981d). The FSA-2510 “Notice of Availability of Loan Servicing to Borrowers who are 90 days past due” is included as Appendix A and B to Subpart C of 7 CFR part 766.
FSA is amending FSA-2510 to incorporate the following changes:
1. Add copies of real estate leases (if applicable to the farm operation) as items necessary for a complete application;
2. Remove references to “good faith;”
3. Add “catastrophic medical expenses for the care of a family member of a borrower or entity member, in the case of an entity borrower” as a circumstance causing delinquency or financial distress beyond the borrower's control for qualification for PLS;
4. Replace the reference to obsolete form SCS-CPA-026 with NRCS-CPA-026e;
5. Remove reference to several forms for a complete loan servicing application as the forms have been consolidated into a single form FSA-2001;
6. Add verification of nonfarm income as a requirement for a complete loan servicing application, which has always been a requirement but was erroneously not included in this form previously;
7. Add a required statement to advise borrowers of the potential tax liability after FSA cancels debt, which may be realized after a write-down, current market value buyout, or debt settlement; and
8. Remove the words “writedown” and “write down” throughout the document and add “write-down” in their places.
The initial regulation for HPRP was published on August 9, 2021 (86 FR 43381-43397), implementing HPRP, which was authorized in the 2018 Farm Bill. In processing the initial HPRP applications, FSA found several areas in need of correction to address the intermediary's HPRP cash accounts, remove barriers to program usage, and encourage intermediary lender participation. FSA is making these changes in 7 CFR part 769, including removing the previous deadline for an intermediary lender to request a loan and to provide for the use of a deposit agreement to securitize HPRP cash accounts in 7 CFR 769.162(a)(1). Additionally, FSA is amending 7 CFR 769.164(d)(9)(ii) to clarify that funds advanced to an intermediary lender that are unused for 6 months must be returned to FSA unless FSA provides a written exception.
The following discussion provides additional detail on the amendments identified as clarifications.
This rule amends the “Agricultural commodity” definition in 7 CFR 761.2(b) to clarify that ornamental plants are an eligible commodity. The definition of “Agricultural commodity” has included, and continues to include, “nursery crops.” When ornamental plants are produced commercially in a typical nursery setting, FSA considers ornamental plants an eligible commodity. Ornamental plants are now specifically named as a separate eligible commodity to clarify that ornamental plants are an eligible commodity. To be considered an ornamental plant, the plant must still be produced commercially in a nursery setting that may include both covered and open-air growing facilities.
This rule revises the definition of “Family farm” in 7 CFR 761.2(b) to clarify that for FLP purposes, a farm must not be a non-eligible enterprise, which includes those farms that do not produce agricultural commodities for uses associated with human consumption, fiber, or draft
This rule amends the definition of “Feasible plan” in 7 CFR 761.2(b) to clarify that when unequal or interest-only installments are scheduled during the initial year(s) of the farm operating plan, a cash flow budget or farm operating plan must be prepared that reflect a typical cycle. This change is consistent with the requirement for other situations in which the planned cash flow budget or farm operating plan is atypical, for example, due to cash or inventory on hand, new enterprises, carryover debt, atypical planned purchases, or important operating changes.
This rule amends the definition of “Good faith” in 7 CFR 761.2(b) to clarify that instances of fraud, waste, or conversion, if substantiated by a legal opinion from the Office of General Counsel (OGC), are an additional independent basis when determining if an applicant or borrower has acted in good faith. To demonstrate good faith an applicant or borrower must adhere to all written agreements with FSA, including any loan agreements, security instruments, farm operating plans, and agreements for use of proceeds. Many actions that qualify as fraud, waste, or conversion also constitute a clear violation of FSA's loan agreement, security instruments, farm operation plans, and agreements for use of proceeds, in which case substantiation by a legal opinion from OGC will not be needed.
This rule amends the definition of “Participated in the business operations of a farm” in 7 CFR 761.2(b) to clarify that owning a farm does not necessarily mean an individual has participated in the business operations of a farm. For example, an absentee landowner who has not been involved in operating, producing, laboring, or making decisions related to operating a farm
The CONACT requires that loans be provided to operators of family farms, and allows for applications from entities, provided that the majority interest is held by members that will operate the farm or are related by blood or marriage, as defined by the Secretary. Family farms often consist of familial relationships beyond traditional immediate family members, for example, parent and child, and increasingly include cousins, half-siblings, and in-laws. To clarify that farm loan assistance is available to family farms comprised of a variety of familial relations, this rule amends the definitions of “Related by Blood or Marriage” and “Relative” in 7 CFR 761.2(b) to include additional familial relationships. These expanded definitions will allow FSA to expand program access and support generational transfers and succession planning.
The 2014 Farm Bill removed requirements that an individual must reside in a rural location to be eligible for a “Youth loan.” While FSA has administratively adopted this change since 2014, FSA will formally recognize the updated definition in 7 CFR 761.2(b) with this clarification. Furthermore, FSA removes the term “Rural youth,” as it is no longer a requirement after the 2014 Farm Bill change.
In the FSA final rule published on August 9, 2021, FSA amended analysis requirements in 7 CFR 761.105(a). The process for completing the analysis in 7 CFR 761.105(b) was not amended consistent with those changes at that time so FSA is clarifying in this rule how the analysis will be completed. A typical analysis includes a review of the prior production cycle's actual income, expense, and production performance, as well as a farm operating plan for the new operating cycle. These financial documents should be prepared by the borrower, with FSA assistance when necessary. Under the regulation, a financial analysis is required if a new direct loan or subordination request is made, or if the account is, or was recently, financially distressed or delinquent. However, an analysis may also be required if FSA believes it is necessary to assist with developing an operation or to address concerns regarding borrower compliance with agreements. FSA also removes references to “year-end” analysis in 7 CFR 761.105 to avoid confusion regarding the potential timing of a required analysis.
The regulation in 7 CFR 765.101(c) requires a borrower to submit all information that FSA requests in conjunction with the routine review of the borrower's financial condition. A review of Federal income tax returns is an important component to ensure that FSA can complete an accurate analysis. This rule clarifies that, in alignment with current practice, borrowers should expect and be prepared to comply with a request for Federal income tax returns as part of the review of the borrower's financial condition.
With the exception of conservation loans, direct farm loan eligibility criteria require applicants to be unable to obtain sufficient credit elsewhere to finance their actual needs at reasonable rates and terms. FSA does not specifically require written denial letters from area lenders for an applicant to qualify for assistance, except in unique circumstances, such as to comply with statutory requirements for EMs.
Some applicants are able to obtain credit from other sources, but the rates and terms offered by those creditors may be at excessive interest rates with unreasonable fees, terms, or collateral requirements that are inconsistent with regional agricultural lending standards and do not meet the needs of the applicant. To aid in determining whether or not available credit elsewhere is reasonable, this rule clarifies 7 CFR 764.51(b)(6) and 764.101(e)(1) to require FSA approval officials to analyze the rates and terms of available credit to ensure they support the generation of a reasonable amount of cash flow margin to increase working capital reserves and savings necessary for operational stability and growth, including reasonable savings for retirement and education. This rule clarifies that for the rates and terms of external credit to be reasonable it must provide a reasonable opportunity for long-term growth. FSA approval officials will determine a reasonable amount of cash flow margin to increase working capital reserves and savings by referencing available resources, including regional lending standards and farm financial and classification ratios.
A complete analysis of a farming operation often requires a review of existing and proposed real estate and equipment leases. Additionally, FSA has regularly required submission of documents such as contracts or purchase options, especially when the contract or option is related to property for which the loan is requested. This rule adds 7 CFR 766.102(a)(8) and revises 7 CFR 764.51(b)(10) to clarify that an applicant must provide leases, contracts, options, or other agreements to FSA, upon request, as part of a complete direct loan making or servicing application. Additionally, this rule revises 7 CFR 764.51(b)(10) to clarify that the requested documents are those that are associated with the borrower's “operation.”
This rule also amends 7 CFR 766.102(a) to correct a reference to an obsolete regulation, and to remove the requirement for borrowers to sign an acknowledgement form to request direct loan servicing, as the acknowledgement has been consolidated into the FSA-2001 application for direct loan servicing, which is required for all such requests.
An applicant's credit history is considered in nearly every lender's analysis of risk associated with the extension of credit. FSA also considers credit history when determining an applicant's eligibility for direct loans. To qualify for a direct loan from FSA an applicant must demonstrate acceptable credit history. However, unlike many commercial lenders, FSA does not base an ultimate eligibility decision on the applicant's credit score. FSA does not find an applicant's credit history to be unacceptable if the applicant has no record of past credit, or if an applicant has a history of failure to repay past debts due to circumstances outside of the applicant's control.
Since family farms do not always obtain debt that demonstrates relevant credit history in the name of the applicant entity, FSA must assess the credit history of the underlying entity members in order to adequately assess
All guaranteed loan applicants must meet basic eligibility criteria. Two of the existing criteria require that an applicant must not have caused FSA a previous loss (except in limited circumstances), and the applicant must meet creditworthiness requirements by demonstrating a successful history of repaying debts as they come due. Applicants sometimes repay previous losses to the government, but creditworthiness requirements still must be assessed to ensure the applicant represents a good prospect of loan repayment. This rule amends 7 CFR 762.120 to clarify even if a previous loss is repaid, the applicant must still satisfy creditworthiness requirements in order to receive new guaranteed loan assistance.
Farmers experience significantly different challenges compared to other business operators. To assist direct loan applicants to be successful and to manage FSA's credit risk, eligible direct loan applicants must demonstrate that they possess sufficient managerial ability to ensure reasonable prospects of loan repayment. Applicants may demonstrate the required managerial ability in a variety of ways, including through education, on-the-job training, and actual farming experience (7 CFR 764.101(i)).
Entity applicants are required to demonstrate managerial experience. Entity structures cannot possess experience, but rather it is the individual entity members who possess the managerial ability necessary to satisfy the requirements. FSA is clarifying the CONACT requirement that for an entity applicant to satisfy the managerial ability eligibility requirement, the individuals holding a majority interest in the entity must possess the required experience.
FSA is clarifying that a history of an entity applicant simply owning a farm does not necessarily satisfy managerial ability requirements. As discussed above, amendments to the definition of “Participated in the Business Operations of a Farm” clarify that simply owning a farm does not necessarily mean an individual has participated in the business operations. Consistent with this definition change and the reasons discussed above, the word “owner” has been removed from 7 CFR 764.101(i)(3).
FSA is also clarifying the lookback period for FSA to consider prior farming experience for an applicant to meet the eligibility requirement based on farming experience prior to the date of the direct loan application in 7 CFR 764.101(i)(3). There has been confusion among applicants due to the use of two different lookback periods for similar experience requirements in the regulations. For certain specific direct FO experience requirements, the lookback period is 10 years, yet the lookback period for farming experience to meet the general managerial ability requirement has been 5 years. FSA is amending the lookback period for farming experience to meet the general managerial ability requirement from 5 years to 10 years to align more closely with the farm experience eligibility requirement specific to direct FO applicants, as provided in 7 CFR 764.152(d). FSA recognizes that increasingly available online education resources and mentorship opportunities can ensure applicants have a reasonable prospect for success, even if their actual farming managerial experience was gained more than 5, but less than 10, years ago. Accordingly, FSA is confident that expanding the general managerial ability experience lookback period to align with the FO lookback period will expand opportunity for applicant access to credit.
The CONACT provides a special interest rate for ML-OL in Section 316(a)(2). ITLAP is authorized outside of the CONACT, but loans made under ITLAP are subject to the interest rate provisions under the CONACT applicable to the low-income farm ownership loan program at Section 307(a)(3)(B) that provides a reduced interest rate for limited resource applicants. In both cases, the interest rate formula is inherently ambiguous, making it difficult to determine the appropriate interest rate for these direct loans. FSA is amending 7 CFR 764.254(a)(4) and 770.6(b) to clarify that the interest rate for ML-OLs and ITLAP is equal to the existing OL rate and FO rate, respectively, but not to exceed 5 percent. This change will resolve the existing confusion about the requirements and benefit applicants by providing a rate ceiling that is consistent with the reasonable historic interpretation of the CONACT interest rate formula. The CONACT does not provide for a special interest rate for ML-FOs. FSA will continue to determine the ML-FO rate using the same methodology as a regular FO.
This rule adds 7 CFR 765.402(f) and (g), 765.403(f) and (g), and 765.404(g) to clarify that transfer and assumption requests require a complete application from transferees to ensure borrower eligibility and the feasibility of the operation, and to clarify that all direct loan security must be transferred to the new borrower as a condition of approval.
The equitable relief provisions published in 7 CFR 768.1 on March 9, 2022 (87 FR 13117-13127) require minor technical correction to clarify in 7 CFR 768.1(a) that equitable relief may be considered for the borrower or borrower's loan due to noncompliance with either legal or regulatory requirements.
The Administrative Procedure Act (APA, 5 U.S.C. 553) provides that the notice and comment and 30-day delay in the effective date provisions do not apply when the rule involves a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts. This rule involves a program for loans and thus falls within the exemption for rules related to loans. FSA is requesting comments on this rule to determine if additional improvements need to be made in the future to the regulations.
This rule is exempt from the regulatory analysis requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996.
Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act) requires a delay in the effective date for 60 days from the date of publication to allow for Congressional review of rules that meet the criteria specified in 5 U.S.C. 804(2). The Office of Information and Regulatory Affairs has determined that this rule does not meet the criteria in 5 U.S.C. 804(2).
Therefore, this rule is effective September 25, 2024.
Executive Order 12866 (as amended by Executive Order 14904), “Regulatory Planning and Review,” and Executive Order 13563, “Improving Regulation and Regulatory Review,” 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 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
The Office of Management and Budget (OMB) designated this rule as significant under Executive Order 12866, “Regulatory Planning and Review,” and therefore, OMB has reviewed this rule. The costs and benefits of this rule are summarized below. The full cost benefit analysis is available on
The cost benefit analysis covers implementation of an improved approach to loan servicing for FSA farm loan programs that is designed to remove barriers to capital access and increase flexibilities for borrowers. This new approach includes a newly created DBSA Program that can be used by both distressed and delinquent borrowers. In addition, numerous modifications to existing programs are being made that offer borrowers greater flexibility and improve their amount of working capital—regardless of whether they are distressed or delinquent.
All changes to the loan programs that are anticipated to impact the net present value of the cost of providing loans, loan guarantees, or modification therefore, will be incorporated into subsidy cost for each relevant risk category and cohort year of loans or loan guarantees.
The changes in this final rule are consistent with numerous aspects of FSA's ongoing efforts to remove barriers to capital access and increase opportunities for FLP borrowers to be successful. The subsidy rate and cost impact of the changes in this final rule vary across the types of changes, including some increases and decreases. Specifically, introducing more flexible repayment terms is expected to increase income receipts and reduce program subsidy costs for several direct loan programs. Several changes, such as reduced security requirements and flexible repayment terms are also expected to increase subsidy costs as a result of increased losses or decreased recoveries. FSA anticipates administrative savings from reduced workload in processing primary loan servicing and monitoring security instruments and an overall reduction in burden. burden.
Prior to this rule, only PLS and the DSA Program were available to help distressed borrowers on an ongoing basis. PLS involves restructuring the loan, usually by deferring some or all of the borrower's upcoming installment payments to the end of the loan term. Alternatively, if the borrower is operating in a county that is declared a major disaster, they can apply for loan servicing through the DSA Program. If the borrower selects PLS, they must provide a significant amount of financial information and develop a projection of income and expenses for the next year.
With this rule, DBSA offers both distressed and delinquent direct borrowers—along with FSA field staff—a more streamlined opportunity to help navigate financial difficulties. DBSA allows financially distressed or delinquent direct loan borrowers—with FOs, OLs, CLs, SWs, or EMs—to request a one-time deferral of a delinquent or upcoming annual installment. The amount of the deferral is limited to the lesser of the amount of the annual installment or the unpaid balance remaining on the installment at the time the DBSA is approved. The amount deferred has a reduced interest rate of 0.125 percent, the lowest interest rate authorized by the CONACT.
DBSA only applies to outstanding loans as of September 25, 2024, the date the rule becomes effective, and as a result, the cost of implementing the regulation (loan modification cost) reflects:
(1) the reduction in the present value of interest receipts (due to the 0.125 percent noted above), and
(2) the reduction in the present value of principal installments over the life of DBSA.
Consequently, FSA will pay the for the modification cost of DBSA upfront using funds from section 22006 of the Inflation Reduction Act.
In addition to DBSA, the rule contains interrelated provisions that provide borrowers with expanded opportunities to allocate working capital toward long-term financial goals. For example, the rule provides all direct loan applicants the option to receive flexible repayment terms for most loan requests (including interest-only payments during the first year, partial principal payments, and longer loan maturity terms). These flexibilities free up some of the borrowers' funds that would otherwise have been used to make larger loan payments. Funds can be used to ensure that their farm operating plan budgets have additional funding to increase working capital reserves and savings, including reasonable savings for retirement and education. These changes are expected to increase interest payments to USDA, which would reduce program subsidy costs, but the changes are also expected to result in an increase in defaults and would increase subsidy costs. Implementation of the changes in this rule are subject to FSA reflecting subsidy costs in accordance with 2 U.S.C. 661(D) and 661b(a), and OMB Circular A-11 section 185.3(s).
Further, the rule lowers the security margin required of the borrower from 150 to 125 percent at the time of loan origination, while still requiring all loans to be fully secured. If the applicant does not have sufficient assets to achieve this security margin, FSA still provides the loan as long as there is adequate security to ensure a 100 percent security margin. However, if additional security is available, FSA currently requires a lien on additional security assets in order to achieve a 150 percent security margin. A requirement this high, however, can hinder the ability of customers to leverage assets into additional growth opportunities. In addition, FSA will no longer take the primary residence as additional security and will not require non-real estate assets to be pledged as additional security for real estate loans. The rule also expands the opportunity for a borrower to request a partial release of certain security if they have a demonstrated history of positive repayment with FSA for the previous 36 months (including scheduled principal reductions) and the loan will still be adequately secured after the release. FSA currently allows for the release of unnecessary security in limited
In addition to the more significant items above, the rule is making changes to other direct and guaranteed loan provisions. For example, the rule clarifies that catastrophic medical expenses for the care of a family member of the borrower or entity member could be a justification for financial distress and makes them eligible for PLS; the maximum value of youth loans is increased from $5,000 to $10,000 to account for inflation; and other minor changes. The cost impact from these smaller changes is expected to be de minimus.
The environmental impacts of this final rule have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and the FSA regulation for compliance with NEPA (7 CFR part 799). The DBSA Program is being implemented as a servicing tool to help financially distressed borrowers. In addition to adding DBSA, FSA is making discretionary changes throughout the FLP regulations to clarify and amend existing delivery processes, program requirements, and technical corrections or clarifications.
The provisions of this rule regarding DBSA is covered by the Categorical Exclusions, found in 7 CFR part 799.31(b)(1)(iii) for debt set-asides when no Extraordinary Circumstances (§ 799.33) exist. The discretionary changes to the regulations are covered by the Categorical Exclusions, found in 7 CFR 799.31(b)(3)(i) for issuing minor technical corrections to regulations, handbooks, and internal guidance, as well as amendments to regulations when no Extraordinary Circumstances (§ 799.33) exist.
Through this review, FSA has determined that neither the implementation of the DBSA Program and the participation in the DBSA Program, nor the discretionary changes to the regulations, constitutes major Federal actions that would significantly affect the quality of the human environment, individually or cumulatively. Therefore, FSA will not prepare an environmental assessment or environmental impact statement for this rule; this rule serves as documentation of the programmatic environmental compliance decision for this Federal action.
Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials that would be directly affected by proposed Federal financial assistance. The objectives of the Executive Order are to foster an intergovernmental partnership and a strengthened Federalism, by relying on State and local processes for State and local government coordination and review of proposed Federal Financial assistance and direct Federal development. For reasons specified in the final rule related notice regarding 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983), the programs and activities within this rule are excluded from the scope of Executive Order 12372.
This rule has been reviewed in accordance with Executive Order 12988, “Civil Justice Reform.” This rule will not preempt State or local laws, regulations, or policies unless they represent an irreconcilable conflict with this rule. Before any judicial actions may be brought regarding the provisions of this rule the administrative appeal provisions of 7 CFR part 11 and 780 are to be exhausted.
This rule has been reviewed under Executive Order 13132, “Federalism.” The policies contained in this rule do not have any substantial direct effect on States, on the relationship between the Federal government and the States, or the distribution of power and responsibilities among the various levels of government, except as required by law. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required.
This rule has been reviewed for compliance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
FSA has assessed the impact of this rule on Indian Tribes and determined that this rule does not, to our knowledge, have significant Tribal implications that require ongoing adherence to Executive Order 13175 at this time. Tribal governments are not eligible for FSA direct and guaranteed loans, so the reach of this rule and impact with Tribes is somewhat limited. Tribes are eligible for FSA's Highly Fractionated Indian Land Loan Program (HFIL) and ITLAP. USDA and FSA have conducted a series of Tribal consultations to obtain input from Tribes and Native producers on our FSA loan programs.
Specifically, we received considerable feedback in 2021, 2022, and 2023 on how USDA can better incorporate traditional foods into FPAC programs as a whole. In fact, one of the top four tribal barriers in 2021 USDA Tribal Consultations was the need to improve and expand support for traditional foods and food ways into FSA and FPAC programs.
In response, in 2022, Administrator Zach Ducheneaux formalized an advisory group of the leadership team to address recommendations by Tribal leadership in USDA Tribal Consultations, reduce barriers to program participation and implement priorities for Indian Country. In the 2022 and 2023 USDA Tribal Consultations, USDA requested more specific input from Tribal leaders on traditional food ways and crops, including wild rice, that Tribal Nations seek to be added into USDA programs.
As a result, this rule includes wild rice and other Tribal foraging practices in Indian Country where it was previously excluded. This is one of the actions FSA has made to be more inclusive to Tribal agricultural producers in indigenous ways in broadly applicable loan programs by improving the interpretation of the authorizing law in the regulation. If a Tribe requests further consultation, FSA will coordinate with the USDA Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications are not expressly mandated by law.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4) requires Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments or the private sector. Agencies generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures of $100 million or more in any 1 year for State, local, or Tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates, as defined in Title II of UMRA for State, local, or Tribal governments, or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
The title and number of the Federal assistance programs, as found in the Assistance Listing
10.099 Conservation Loans;
10.404 Emergency Loans;
10.406 Farm Operating Loans; and
10.407 Farm Ownership Loans.
For the various regulatory changes being made by this rule, FSA will continue to use some forms that already are currently approved under the OMB control number of 0560-0233, 0560-0237 and 0560-0238.
This rule does not change the following approved information collection under OMB control numbers:
• 0560-0155, Guaranteed Farm Loan Programs, OMB Expiration Date of November 2026;
• 0560-0233, Farm Loan Programs—Direct Loan Servicing, OMB Expiration Date of October 2024;
• 0560-0237, Farm Loan Programs—Direct Loan Making, OMB Expiration Date of January 2026;
• 0560-0238, Farm Loan Programs—General Program Administration, OMB Expiration Date of October 2026; and
• 0560-0317, Online Loan Application, OMB Expiration Date of November 2026.
For the information collection changes related to the existing approvals under 0560-0155, Guaranteed Farm Loan Programs, and 0560-0317, Online Loan Application, there are no new forms, no changes in the per response time for the information collection activities, and not changes in the number of respondents.
For the information collection changes related to the existing approval under 0560-0233, operationally, there is a potential increase of approximately 2,000 in the number of respondents, related to an increase in the requests for DBSA and DSA. The approved burden estimates for 0560-0233 includes 8,692 DSA applications annually. Actual requests over the last 5 years have averaged 786 applications, so the anticipated increase in requests is well within the existing approved burden estimate.
For the information collection changes related to the existing approval under 0560-0236, operationally, there is a potential increase in requests for security releases and leasing of property. The approved burden estimates for 0560-0236 includes 455 requests for lease security annually. Actual lease security requests have averaged less than 100, so the anticipated increase in requests is well within the existing approved burden estimate. As explained below, the form used for requesting security releases is expected to increase in the number of respondents beyond what is currently approved for the form under 0560-0236.
For the information collection changes related to the existing approval under 0560-0237, operationally, FSA expects an increase in the actual number of respondents due to increasing the youth loan limit. This might increase the youth loan demand by a few hundred applications. The approved burden estimates for 0560-0237 includes 4,410 applications annually. The 5-year average has only been 2,056 applications, so the anticipated increase in youth loans is well within the existing approved burden estimate.
This rule does increase the expected number of respondents who will request a release of security using form FSA-2061—Application for partial release or consent. That form is approved under OMB 0560-0236, Farm Loan Programs: Direct Loan Servicing, Regular. FSA requested an emergency approval from OMB to cover the increase of the borrowers in using a release of security (Form FSA-2061—Application for partial release or consent). The rest of this section provides the information related to the requests for comments for these changes.
FSA is requesting comments from all interested individuals and organizations on a new information collection associated with the release of security (the form FSA-2061) for the Direct Loan Servicing—Regular information collection activity. This rule expands opportunities to release liens on additional collateral for borrowers with a demonstrated history of successful direct loan repayment. After 3 years of successful loan repayment and principal reduction, a borrower can request FSA to release liens on additional security items provided the loan will continue to be fully secured. The borrower formally requests to be considered for a release of security using form FSA-2061—Application of Partial Release or Consent. FLP anticipates an increase in the use of the FSA-2061 as more borrowers will be able to qualify for a lien release than before.
For the following estimated total annual burden on respondents, the formula used to calculate the total burden hour is the estimated average time per response multiplied by the estimated total annual responses.
Public reporting burden for this information collection is estimated to average 0.50 hours per response.
FSA is requesting comments on all aspects of this information collection to help us to:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the FSA, including whether the information will have practical utility;
(2) Evaluate the accuracy of the FSA's estimate of burden including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility and clarity of the information to be collected; and
(4) 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. All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for Office of Management and Budget approval.
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Individuals who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or the USDA TARGET Center at (202) 720-2600 (voice and text telephone (TTY)) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any telephone). Additionally, program information may be made available in languages other than English.
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
USDA is an equal opportunity provider, employer, and lender.
Accounting, Loan programs—agriculture, Rural areas.
Agriculture, Credit, Loan programs—agriculture.
For the reasons discussed above, FSA amends 7 CFR chapter VII as follows:
5 U.S.C. 301 and 7 U.S.C. 1989.
The additions and revisions read as follows.
(a) * * *
(b) * * *
(i) Meets the loan eligibility requirements for a direct or guaranteed CL, FO, or OL, as applicable;
(ii) Has not operated a farm for more than 10 years. This requirement applies to all members of an entity;
(iii) Will materially and substantially participate in the operation of the farm:
(A) In the case of a loan made to an individual, individually or with the family members, material and substantial participation requires that the individual provide substantial day-to-day labor and management of the farm, consistent with the practices in the county or State where the farm is located; or
(B) In the case of a loan made to an entity, all members must materially and substantially participate in the operation of the farm. Material and substantial participation requires that the member provide some amount of the management, or labor and management necessary for day-to-day activities, such that if the individual did not provide these inputs, operation of the farm would be seriously impaired;
(iv) Agrees to participate in any loan assessment and borrower training required by Agency regulations;
(v) Except for an OL applicant, does not own real farm property or who, directly or through interests in family farm entities owns real farm property, the aggregate acreage of which does not exceed 30 percent of the average farm acreage of the farms in the county where the property is located. If the farm is located in more than one county, the average farm acreage of the county where the applicant's residence is located will be used in the calculation. If the applicant's residence is not located on the farm or if the applicant is an entity, the average farm acreage of the county where the major portion of the farm is located will be used. The average county farm acreage will be determined from the most recent Census of Agriculture;
(vi) Demonstrates that the available resources of the applicant and spouse (if any) are not sufficient to enable the applicant to enter or continue farming on a viable scale; and
(vii) In the case of an entity:
(A) All the members are related by blood or marriage; and
(B) All the members are beginning farmers.
(i) Debt forgiveness includes:
(A) Writing down or writing off a debt pursuant to 7 U.S.C. 2001;
(B) Cancellation of remaining amounts owed after compromising, adjusting, reducing, or charging off a debt or claim pursuant to 7 U.S.C. 1981;
(C) Paying a loss pursuant to 7 U.S.C. 2005 on a FLP loan guaranteed by the Agency;
(D) Discharging a debt as a result of bankruptcy; or
(E) Releases of liability which result in a loss to the Agency.
(ii) Debt forgiveness does not include:
(A) Debt reduction through a conservation contract;
(B) Any write-down provided as part of the resolution of a discrimination complaint against the Agency;
(C) Prior debt forgiveness that has been repaid in its entirety;
(D) Consolidation, rescheduling, reamortization, or deferral of a loan; and
(E) Forgiveness of a YL debt due to circumstances beyond the borrower's control.
(i) Are those that are basic, crucial, or indispensable;
(ii) Are determined by the Agency based on the following considerations:
(A) The specific borrower's operation;
(B) What is typical for that type of operation in the area; and
(C) What is an efficient method of production considering the borrower's resources; and
(iii) Include, but are not limited to, essential: Household operating expenses; food, including lunches; clothing and personal care; health and medical expenses, including medical insurance; house repair and sanitation; school and religious expenses; transportation; hired labor; machinery repair; farm building and fence repair; interest on loans and credit or purchase agreement; rent on equipment, land, and buildings; feed for animals; seed, fertilizer, pesticides, herbicides, spray materials and other necessary farm supplies; livestock expenses, including medical supplies, artificial insemination, and veterinarian bills; machinery hire; fuel and oil; taxes; water charges; personal, property and crop insurance; auto and truck expenses; and utility payments.
(i) Produces agricultural commodities, including agricultural commodities commercially foraged on Indian land for the purposes of OLs, for sale in sufficient quantities so that it is recognized as a farm rather than a rural residence or non-eligible enterprise;
(ii) Has both physical labor and management provided as follows:
(A) The majority of day-to-day, operational decisions, and all strategic management decisions are made by:
(
(
(B) A substantial amount of labor to operate the farm is provided by:
(
(
(iii) May use full-time hired labor in amounts only to supplement family labor; and
(iv) May use reasonable amounts of temporary labor for seasonal peak workload periods or intermittently for labor intensive activities.
(i) Owned by an Indian Tribe;
(ii) Owned by an Indian Tribe and is subject to restrictions against alienation or encumbrance by the United States; or
(iii) Held in trust by the United States for an Indian Tribe.
(i) Produces exotic animals, birds, or aquatic organisms or their products that may be agricultural in nature, but are not primarily associated with agricultural production, for example, there is no established or stable market for them, or production is speculative in nature;
(ii) Produces animals, birds, or aquatic organisms ordinarily used for pets, companionship, sport, or pleasure and not primarily associated with human consumption, fiber, or draft use;
(iii) Primarily markets goods or provides services which might be agriculturally related, but are not produced by the farming operation; or
(iv) Processes or markets farm products when the majority of the commodities processed or marketed are not produced by the farming operation.
(i) Do not contribute to:
(A) Income to pay essential family living expenses, or
(B) The farming operation; and
(ii) Are not exempt from judgment creditors or in a bankruptcy action.
(i) The per acre actual production history of the crops produced by the farming operation used to determine Federal crop insurance payments or payment under the Noninsured Crop Disaster Assistance Program for the production year during which the disaster occurred;
(ii) The applicant's own production records, or the records of production on which FSA Farm Program payments are made contained in the applicant's Farm Program file, if available, for the previous 3 years, when the actual production history in paragraph (i) of this definition is not available;
(iii) The county average production yield, when the production records outlined in paragraphs (i) and (ii) of this definition are not available.
(i) Been the manager or operator of a farming operation for the year's complete production cycle as evidenced by tax returns, FSA farm records or similar documentation;
(ii) Been employed as a farm manager or farm management consultant for the year's complete production cycle; or
(iii) Participated in the operation of a farm by virtue of being raised on a farm or having worked on a farm (which can include a farm-related apprenticeship, internship, or similar educational program with applied work experience) with significant responsibility for the day-to-day decisions for the year's complete production cycle, which may include selection of seed varieties, weed control programs, input suppliers, livestock feeding programs, or decisions to replace or repair equipment.
(i) Loan consolidation and rescheduling, or reamortization;
(ii) Interest rate reduction, including use of the limited resource rate program;
(iii) Deferral;
(iv) Write-down of the principal or accumulated interest; or
(v) Any combination of paragraphs (i) through (iv) of this definition.
The revisions read as follows:
(b) * * *
(3) The short- and long-term goals of the operation, including goals to reasonably increase working capital reserves and savings, including reasonable savings for retirement and education, to support operational stability and growth, and goals for progression towards graduation to commercial credit or eventual self-financing;
(c) * * *
(3) The short- and long-term goals of the operation, including goals to reasonably increase working capital reserves and savings, including reasonable savings for retirement and education, to support operational stability and growth, and goals for progression towards graduation to commercial credit or eventual self-financing;
(4) The short- and long-term financial viability of the farming operation, including a marketing plan, and available production history, as applicable;
The addition reads as follow.
(f) Development of farm operating plans and determination of appropriate repayment terms must include
The revisions read as follows:
(b) The analysis must include a review of the previous production cycle's actual income, expense, and production performance, as well as a farm operating plan for the new operating cycle.
5 U.S.C. 301 and 7 U.S.C. 1989.
(a) * * *
(3) If the debt forgiveness is resolved by repayment of the Agency's loss, the Agency may still consider the debt forgiveness in determining the applicant's creditworthiness.
(e) * * *
(1) Extended repayment schedules may include equal, unequal, or balloon installments if needed by a borrower on any guaranteed loan to establish a new enterprise, develop a farm, recover from a disaster or an economical reversal, or reasonably increase cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education.
The revisions read as follows.
(d) * * *
(2) The transferee must apply for a loan in accordance with § 762.110, and provide any other information requested by the Agency to evaluate the transfer and assumption request. A current appraisal is required unless the lien position of the guaranteed loan will not change.
(5) The transferee must meet the eligibility requirements and loan limitations for the loan being transferred, including all requirements relating to loan rates and terms, loan security, feasibility, and environmental and other laws applicable to an applicant under this part, except for a current appraisal when permitted in paragraph (d)(2) of this section.
The revisions read as follows:
(b) * * *
(4) Loans can be restructured using a balloon payment, equal installments, or unequal installments. Under no circumstances may crops or livestock, other than breeding livestock, be the only security for a loan to be rescheduled using a balloon payment. If a balloon payment is used, the projected value of the security must indicate that the loan will be fully secured when the balloon payment becomes due. The projected value will be derived from a current appraisal adjusted for depreciation of depreciable property, such as buildings and other improvements, that occurs until the balloon payment is due. For other security, a current appraisal is required. The lender is required to project the security value at the time the balloon payment is due based on the remaining life of the security, or the depreciation schedule on the borrower's Federal income tax return. Loans restructured with a balloon payment that are secured by real estate will have a minimum term of 5 years, and other loans will have a minimum term of 3 years before the scheduled balloon payment. If statutory limits on terms of loans prevent the minimum terms, balloon payments may not be used. If the loan is rescheduled with unequal installments, a feasible plan, as defined in § 762.2(b), must be projected for when installments are scheduled to increase.
5 U.S.C. 301 and 7 U.S.C. 1989.
(b) * * *
(6) Except for CL, documentation that the applicant and each member of an entity applicant cannot obtain sufficient credit elsewhere on reasonable rates and terms, including a loan guaranteed by the Agency. The authorized Agency official will evaluate and document whether or not rates and terms of available credit in the applicant's region will result in a reasonable amount of cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education, to support operational stability and growth;
(10) A legal description of the farm property owned or to be acquired and, upon Agency request, any leases, contracts, options, and other agreements related to the operation;
The revisions read as follows:
(d)
(1) As part of the credit history, the Agency will determine whether the applicant, and all entity members in the case of an entity, will carry out the terms and conditions of the loan and deal with the Agency in good faith. In making this determination, the Agency may examine whether the applicant, and all entity members in the case of an entity, has properly fulfilled its obligations to other parties, including other agencies of the Federal Government.
(2) When the applicant, or an entity member in the case of an entity, caused the Agency a loss by receiving debt forgiveness, the applicant may be ineligible for assistance in accordance with eligibility requirements for the specific loan type. If the debt forgiveness is cured by repayment of the Agency's loss, the Agency may still consider the debt forgiveness in determining the applicant's credit worthiness.
(3) A history of failures to repay past debts as they came due will demonstrate unacceptable credit history when the ability to repay was within the control of the applicant, or entity member in the case of an entity. The circumstances in paragraphs (d)(3)(i) through (iv) of this section, for example, do not automatically indicate an unacceptable credit history:
(i) Foreclosures, judgments, delinquent payments which occurred more than 36 months before the application, if no recent similar situations have occurred, or Agency delinquencies that have been resolved through loan servicing programs available under 7 CFR part 766;
(ii) Isolated incidents of delinquent payments which do not represent a general pattern of unsatisfactory or slow payment;
(iii) “No history” of credit transactions; and
(iv) Recent foreclosure, judgment, bankruptcy, or delinquent payment of the applicant, or an entity member in the case of an entity, when it can be satisfactorily demonstrated that the adverse action or delinquency was caused by circumstances that were of a temporary nature and beyond the individual's control; or the result of a refusal to make full payment because of defective goods or services or other justifiable dispute relating to the purchase or contract for goods or services.
(e) * * *
(1) Loan amounts, rates, and terms available in the marketplace. The authorized Agency official will evaluate and document whether rates and terms of available credit will result in a reasonable amount of cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education, to support operational stability and growth; and
(i)
(1)
(2)
(3)
(4)
(i) Certification of a past participation with an agriculture-related organization, such as, but not limited to, 4-H Club, FFA, beginning farmer and rancher development programs, or Community Based Organizations, that demonstrates experience in a related agricultural enterprise; or
(ii) A written description of a self-directed apprenticeship combined with either prior sufficient experience working on a farm or significant small business management experience. As a condition of receiving the loan, the self-directed apprenticeship requires that the applicant seek, receive, and apply guidance from a qualified person during the first cycle of production and marketing typical for the applicant's specific operation. The individual providing the guidance must be knowledgeable in production, management, and marketing practices that are pertinent to the applicant's operation, and agree to form a developmental partnership with the applicant to share knowledge, skills, information, and perspective of agriculture to foster the applicant's development of technical skills and management ability.
(c) An additional amount of security will be required, if available, to reach a 125 percent security margin. Total loan
The revision reads as follows:
(d) Unless the applicant provides a written request for an exemption, when the property includes the primary personal residence and appurtenances of the applicant or any entity member(s) and:
(1) They are located on a separate parcel of up to the greater of 10 acres or the minimum size that meets all State and local requirements for a division into a separate legal lot; and
(2) The security requirements of § 764.103(b) can be satisfied without the use of the primary personal residence and appurtenances;
(b)
(1) The standard repayment term of an FO will be equal to the useful life of the security or 40 years, whichever is less. Repayment terms less than the standard term must be requested by the applicant in writing. In no event will the term be more than 40 years from the date of the note. Repayment schedules may include equal installments, or unequal installments if needed to establish a new enterprise, develop a farm, recover from a disaster or economic reversal, or reasonably increase cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education. Notwithstanding any other provision of this section, repayment schedules must be designed to ensure the loan is fully secured for the life of the loan.
(2) The first installment of an FO will be an interest-only installment scheduled 12 months from the date of loan closing. An alternative repayment agreement that schedules the first installment sooner than 12 months from the date of closing, or in an amount greater than interest-only, may be provided upon written request from the applicant, or if the Agency determines it necessary to ensure the loan is fully secured for the life of the loan.
(3) The minimum scheduled installments for the first 3 years of an FO must be the interest accrued on the principal balance. Interest-only installments may be permitted for additional years, if determined necessary by the Agency, to establish a new enterprise where production income is delayed, to develop a farm, or to recover from a disaster or economic reversal.
(a) * * *
(11) Costs for minor real estate repairs or improvements, provided the loan is made primarily for agricultural purposes and can be repaid within 7 years. In the case of leased property, the applicant must have a lease to ensure use of the improvement over its useful life or to ensure that the applicant receives compensation for any remaining economic life upon termination of the lease.
The revisions and addition read as follows:
(a) * * *
(4) The Agency's Direct ML-OL interest rate on an ML to a beginning farmer or veteran farmer is available in each Agency office. The interest rate will be the lower of the regular direct OL interest rate in effect at the time of loan approval or loan closing, or 5 percent.
(b) * * *
(1) The Agency schedules repayment of OL loans made for annual farm operating and family living expenses when planned income is projected to be available.
(i) The term of the loan may not exceed 24 months from the date of the note, except as provided in paragraph (b)(1)(ii) of this section.
(2) The standard repayment term of all other OLs must be equal to the useful life of the security or 7 years, whichever is less. Repayment terms less than the standard term must be requested by the applicant in writing. In no event will the term of the loan exceed 7 years from the date of the note. Repayment schedules may include equal installments, or unequal or balloon installments if needed to establish a new enterprise, develop a farm, recover from a disaster or economic reversal, or reasonably increase cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education. Notwithstanding any other provision of this section, repayment schedules must be designed to ensure the loan is fully secured for the life of the loan. Loans with balloon installments:
(i) Must be secured by an amount projected at the time of loan closing to be at least equal to the direct loan balance outstanding at the time the balloon installment comes due, which may exceed the additional security requirements of § 764.103(c) of this chapter. Total loan security in excess of the requirements of this provision (paragraph (b)(2)(i) of this section) will only be taken when it is not practicable to separate the security. Crops, livestock other than breeding stock, or livestock products produced are not adequate collateral for such loans.
(ii) Are only authorized when the applicant can project the ability to refinance or restructure the remaining debt at the time the balloon payment comes due based on the expected financial condition of the operation, the depreciated value of the collateral, and the principal balance on the loan.
(iii) Are not authorized when loan funds are used for real estate repairs or improvements.
(3) The first installment of an OL, for purposes other than annual farm operating and family living expenses,
(4) The minimum scheduled installments for the first 3 years of an OL, for purposes other than annual farm operating and family living expenses, must be the interest accrued on the principal balance. Interest-only installments may be permitted for additional years, if determined necessary by the Agency, to establish a new enterprise where production income is delayed, to develop a farm, or to recover from a disaster or economic reversal.
The revisions and addition read as follows:
(b) Except for MLs or OLs made for the purpose of minor real estate repairs or improvements, by a:
(c) * * *
(2) For loans made for purposes other than annual operating purposes or for the purpose of minor real estate repairs or improvements, loans must be secured by a first lien on farm property or products purchased with loan funds and having a security value of at least 100 percent of the loan amount.
(d) For OLs made for the purpose of minor real estate repairs or improvements, the Agency must obtain a lien on the real estate repaired or improved in accordance with the requirements of § 764.104, while also ensuring the provisions of § 764.103(b) requiring adequate security are satisfied.
The revisions and addition read as follows.
(b) * * *
(1) The Agency schedules repayment of EMs based on the useful life of the security and the type of loss.
(3) EMs for annual farm operating and family living expenses, except expenses associated with establishing a perennial crop that are subject to paragraph (b)(4), must be repaid within 12 months. The Agency may extend this term to not more than 24 months to accommodate the production cycle of the agricultural commodities.
(4) The standard repayment term of an EM for production losses or physical losses to chattel security (including assets with an expected life between 1 and 7 years) will be equal to the useful life of the security or 7 years, whichever is less. Repayment terms less than the standard term must be requested by the applicant in writing. The Agency may extend the repayment term up to a total length not to exceed 20 years, if adequate security is available, and repayment schedules may include equal installments, or unequal installments, if needed to establish a new enterprise, develop a farm, recover from a disaster or economic reversal, or reasonably increase cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education, and security is adequate to support the term of the loan. Notwithstanding any other provision of this section, repayment schedules must be designed to ensure the loan is fully secured for the life of the loan.
(5) The standard repayment term of an EM for physical losses to real estate will be equal to the useful life of the security or 40 years, whichever is less. Repayment terms less than the standard term must be requested by the applicant in writing. In no event will the term be more than 40 years from the date of the note, and repayment schedules may include equal installments, or unequal installments, if needed to establish a new enterprise, develop a farm, recover from a disaster or economic reversal, or reasonably increase cash flow margin to increase working capital reserves and savings, including reasonable savings for retirement and education, and security is adequate to support the term of the loan. Notwithstanding any other provision of this section, repayment schedules must be designed to ensure the loan is fully secured for the life of the loan.
(6) The first installment of an EM, for purposes other than annual farm operating and family living expenses, will be an interest-only installment scheduled 12 months from the date of loan closing. An alternative repayment agreement that schedules the first installment sooner than 12 months from the date of closing, or in an amount greater than interest-only, may be provided upon written request from the applicant, or if the Agency determines it necessary to ensure the loan is fully secured for the life of the loan.
(7) The minimum scheduled installments for the first 3 years of an EM, for purposes other than annual farm operating and family living expenses, must be the interest accrued on the principal balance. Interest-only installments may be permitted for additional years, if determined necessary by Agency, to establish a new enterprise where production income is delayed, to develop a farm, or to recover from a disaster or economic reversal.
5 U.S.C. 301 and 7 U.S.C. 1989.
(c) The borrower must submit all information that the Agency requests in conjunction with the review of the borrower's financial condition, including Federal income tax returns.
(a) Borrower failure to fulfill all graduation requirements, including failure to submit information as specified in § 765.101(c) of this chapter, within the time-period specified by the Agency constitutes default on the loan. Except as provided in paragraph (b) of this section, the Agency will accelerate the borrower's loan without offering servicing options provided in 7 CFR part 766 if any outstanding direct loan was closed prior to September 25, 2024.
(b) If all outstanding direct loans were closed after September 25, 2024, or when the borrower makes a written request in response to the Agency's notification of intent to accelerate within provided timeframes, the Agency will convert the debt to a non-program loan under the following conditions:
(1) It is in the interest of the Agency;
(2) The debt will be subject to the interest rate for non-program loans in effect at the time of default;
(3) The debt will be serviced as a non-program loan; and
(4) The term of the non-program loan will be:
(i) For FOs, the Agency will schedule repayment in equal installments over the lesser of the remaining number of years on the loan, the useful life of security, or 25 years.
(ii) For OLs, the Agency will schedule repayment in equal installments over the lesser of the remaining number of years on the loan, the useful life of security or 5 years.
The addition reads as follows.
(b)
The revision reads as follows.
(c)
(1) The term of lease does not exceed 12 months and does not automatically renew;
(2) The lease does not contain an option to purchase;
(3) The lease does not hinder the future operation or success of the farm, or, if the borrower has ceased to operate the farm, the requirements specified in § 765.253 are met;
(4) The lease must be in the best interest of the Agency as determined by the authorized Agency official;
(5) Leased security must be accessible and readily identifiable at all times. Leased livestock must be branded, tagged, or be otherwise specifically identifiable; and
(6) The lease and any contracts or agreements in connection with the lease must be reviewed and approved by the Agency.
(c) The Agency will release its lien on chattel security without compensation, after written request from the borrower, provided all the following criteria are satisfied:
(1) The borrower is current on all loan accounts with FSA and has not received PLS, DBSA, or DSA on any loan within the last 36 months;
(2) The borrower has paid in full scheduled direct term loan installments that include principal reduction in each of the last 3 calendar years;
(3) After the release, the security margin on each Agency direct loan will be 125 percent (or more, if it is not practicable to separate the property, if necessary to ensure the loan is fully secured for the life of the loan, or if the borrower requests only a portion of Agency security to be released). The value of the retained and released security will normally be based on appraisals obtained as specified in § 761.7 of this chapter; however, well-documented recent sales of similar properties can be used if the Agency determines a supportable decision can be made without current appraisals;
(4) Any asset requested for release must serve only as security for term
(5) Except for CL, the borrower is unable to fully graduate as specified in § 765.101.
The revision reads as follows.
(f)
(1) The borrower is current on all loan accounts with FSA and has not received PLS, DBSA, or DSA on any loan within the last 36 months;
(2) The borrower has paid in full direct term loan installments that include principal reduction in each of the last 3 calendar years;
(3) The property released will not interfere with access to or operation of the remaining farm;
(4) Essential buildings and facilities will not be released if they reduce the utility or marketability of the remaining property;
(5) Any issues arising due to legal descriptions, surveys, environmental concerns, utilities are the borrower's responsibility, and no costs or fees will be paid by FSA;
(6) After the release, the security margin on each Agency direct loan will be 125 percent (or more, if it is not practicable to separate the property, if necessary to ensure the loan is fully secured for the life of the loan, or if the borrower requests only a portion of Agency security to be released). The value of the retained and released security will normally be based on appraisals obtained as specified in § 761.7 of this chapter; however, well-documented recent sales of similar properties can be used if the Agency determines a supportable decision can be made without current appraisals;
(7) Any asset requested for release must serve only as security for term loan(s) that have been outstanding for at least the prior 36 months and cannot serve as adequate security for another existing Agency direct loan; and
(8) Except for CL, the borrower is unable to fully graduate as specified in § 765.101.
(4) To pay capital gains taxes on real estate transactions when the following conditions are met:
(i) The borrower is unable to obtain commercial credit at reasonable rates and terms to pay the capital gains taxes;
(ii) The Agency approves the amount to be retained to pay capital gains taxes;
(iii) The remaining Agency debt is fully secured;
(iv) All other lienholders will:
(A) Be fully satisfied from the sale, or
(B) Consent to the use of proceeds to be used to pay capital gains taxes;
(v) At the borrower's expense, funds will be held in escrow, or deposited in a supervised bank account in accordance with subpart B of part 761 of this chapter; and
(vi) Funds that are not used within 18 months towards the capital gains taxes will be remitted to the Agency.
The revisions and additions read as follows.
(b) A relative of the borrower or an entity comprised solely of relatives of the borrower assumes the debt along with the original borrower;
(d) A new entity consisting of the same members as the borrower entity buys the borrower entity and continues to operate the farm in accordance with loan requirements; or
(e) * * *
(1) An individual borrower, the transferee must be a relative of the original borrower or an entity in which the entity members are comprised solely of relatives of the original borrower.
(f)
(g)
(f)
(g)
(d)
(g)
5 U.S.C. 301, 7 U.S.C. 1989, and 7 U.S.C. 1981d(c).
(b) * * *
(1) * * *
(i) May not receive DSA under subpart B of this part or DBSA under subpart J of this part;
(b) * * *
(2) The borrower must provide any additional information requested by the Agency.
(e)
The addition reads as follows:
(a) * * *
(8) Upon Agency request, any leases, contracts, options, and other agreements related to the operation.
The addition reads as follows.
(a) * * *
(1) * * *
(vi) Catastrophic medical expenses for the care of a family member of the borrower or entity member, in the case of an entity borrower.
The revisions read as follows:
(b) * * *
(1) Rescheduling, consolidation, reamortization, deferral or some combination of these options on all of the borrower's loans would not result in a feasible plan with a 110 percent debt service margin. If a feasible plan is achieved with a debt service margin of 101 percent or more, the Agency will permit a borrower to accept a non-write-down servicing offer and waive the right to a write-down offer when the write-down offer will require additional time and appraisals to fully develop. If after obtaining an appraisal a feasible plan is achieved with and without a write-down and the borrower meets all the eligibility requirements, both options will be offered, and the borrower may choose one option.
(a) If the borrower is delinquent prior to restructuring, an additional amount of security will be required, if available, to reach a 125 percent security margin when the Agency is servicing a loan, except as provided in paragraph (b) of this section. Total loan security in excess of what is needed to achieve a security margin of 125 percent will only be taken when it is not practicable to separate the security.
(b) The Agency will take the best lien obtainable on assets of the borrower and co-borrowers to meet the 125 percent security margin requirement, except that the following assets will not be considered available to meet this requirement:
(1) When taking a lien on an asset will prevent the borrower from obtaining credit from other sources;
(2) When an asset could have significant environmental problems or costs as described in part 799 of this chapter;
(3) When the Agency cannot obtain a valid lien;
(4) When an asset is subsistence livestock, cash, special collateral accounts the borrower uses for the farming operation, retirement accounts, education savings accounts, personal vehicles necessary for family living, household contents, or small equipment such as hand tools and lawn mowers; or
(5) When a contractor holds title to a livestock or crop enterprise, or the borrower manages the enterprise under a share lease or share agreement.
(a) * * *
(1) Obtain a USPAP compliant technical appraisal review prepared by a State Certified General Appraiser of the Agency's appraisal and provide it to the Agency within 90 days of the request for reconsideration or appeal and prior to reconsideration or the appeal hearing;
(2) Obtain an independent appraisal within 90 days of the request for reconsideration or appeal request and completed in accordance with § 761.7 as part of the request or reconsideration or appeals process. The borrower must:
(3) Use the second appraisal completed under paragraph (a)(2) of this section to negotiate the Agency's appraisal.
(ii) If the difference between the two appraisals is greater than five percent, the borrower may request a third appraisal within 30 days from the date the second appraisal is provided to the Agency. The Agency and the borrower will share the cost of the third appraisal
(a) At a borrower's written request, the maturity date and installment schedule of a direct term loan with a balloon payment may be extended for up to an additional 8 years from the original maturity date using an addendum to the promissory note when the:
(1) Loan was originally amortized for no more than 15 years with a balloon payment scheduled in the final year of the loan;
(2) Loan has not received PLS, DBSA, or DSA;
(3) Borrower has made all scheduled loan installments in the last 36 months;
(4) Balloon payment is due in less than 12 months;
(5) Borrower does not have an outstanding DBSA or DSA on any loan;
(6) Borrower has not received PLS on any loan in the last 36 months;
(7) Borrower has only had equal installments scheduled on any direct term loan in the last 36 months;
(8) Borrower's direct loans are fully secured with each loan having a security value of at least 100 percent of the remaining balance of the loan;
(9) Borrower is unable to partially or fully graduate;
(10) Borrower has acted in good faith;
(11) Borrower is not otherwise financially distressed or delinquent;
(12) Borrower must pay a portion of the interest due on the loan; and
(13) Addendum is signed by the borrower before the original maturity date.
(b) In no event may the loan exceed applicable term limits described in this part.
(a) DBSA is available to borrowers with at least one outstanding program loan authorized in subtitle A, B, or C of the CONACT (the loan must be an OL, FO, CL, SW, or EM), and who are a delinquent borrower or financially distressed borrower.
(b) DBSA is not intended to circumvent other servicing available under this part.
(a)
(1) The borrower must currently be operating the farm. Farmers who have rented out their land base for cash are not considered to be operating the farm.
(2) The borrower must have acted in good faith, and the borrower's inability to make the current or upcoming scheduled loan payments must be for reasons not within the borrower's control.
(3) The borrower cannot have more than one DBSA on each loan.
(4) The borrower does not have sufficient income available to pay all family living and farm operating expenses, other creditors, and debts to the Agency. This determination will be based on:
(i) The borrower's actual production, income and expense records; and
(ii) Any other records required by the Agency;
(5) For the next production cycle, the borrower must develop a feasible plan showing that the borrower will at least be able to pay all operating expenses and taxes due during the year, essential family living expenses, and meet scheduled payments on all debts, including Agency debts. The borrower must provide documentation required to support the farm operating plan.
(6) The borrower must not be in non-monetary default.
(7) The borrower must not be ineligible due to disqualification resulting from Federal crop insurance violation according to 7 CFR part 718.
(8) The borrower must not become 165 days past due before the appropriate Agency DBSA documents are executed.
(b)
(1) To be considered for DBSA the loan must have been either an OL, FO, CL, SW or EM outstanding prior to September 25, 2024.
(2) All of the borrower's program and non-program loans must be current after the Agency completes DBSA for the scheduled payment installment.
(3) All FLP loans must either be current or less than 150 days past due at the time the complete application for DBSA is received by the Agency.
(4) The Agency has not accelerated the borrower's account.
(5) For any loan that will receive DBSA, the remaining term of the loan must equal or exceed 2 years from the due date of the DBSA agreement.
(6) The loan must not have an existing DBSA or DSA in place.
(7) The loan must not have been consolidated with any other loan that would not be eligible for DBSA on its own merits.
(a) The DBSA amount is limited to the lesser of:
(1) The amount of the delinquent installment or upcoming scheduled installment; or
(2) The amount the borrower is unable to pay the Agency. Borrowers are required to pay any portion of an installment they are able to pay.
(b) The amount set aside will be the unpaid balance remaining on the installment at the time DBSA is complete. The amount will include the unpaid interest and any principal that would be credited to the account as if the installment were paid on the due date, taking into consideration any payments applied to principal and interest since the due date.
(c) Recoverable cost items may not be set aside.
(a)
(1) A borrower must submit a request for DBSA to the Agency in writing.
(2) All borrowers liable for the loan must sign the DBSA request.
(b)
(1) The borrower must submit actual production, income, and expense records for the current and upcoming production cycle unless the Agency already has that information for the borrower.
(2) The borrower must provide any additional information requested by the Agency.
Subject to the 165-calendar day limitation in § 766.452(a)(8), the borrower must execute the appropriate Agency documents within 45 days after the borrower receives notification of Agency approval of DBSA, which will be within 30 days of having submitted a complete application.
(a)
(b)
(c)
(a) The Agency will cancel a DBSA agreement if the Agency takes any PLS action on the loan.
(b) The Agency will cancel a DBSA agreement if the borrower pays the:
(1) Current market value buyout in accordance with § 766.113; or
(2) The set-aside installment.
If the Agency determines that the borrower received an unauthorized DBSA, the Agency will reverse the DBSA agreement after all appeals are concluded.
This appendix A contains the notification (form letter) that the Farm Service Agency will send to borrowers who are at least 90 days past due on their loan payments. It provides information about the loan servicing that is available to the borrower. As stated below on the notification, the borrower is to respond within 60 days from receiving the notification (see § 766.101(b)(2) and (d)(2) for the requirements). The notification is provided here as required by 7 U.S.C. 1981d.
This appendix contains the notification (form letter) that the Farm Service Agency will send to borrowers with loans in Iowa who are at least 90 days past due on their loan payments. It provides information about the loan servicing that is available to the borrower. As stated below on the notification, the borrower is to respond within 60 days from receiving the notification (see § 766.101(b)(2) and (d)(2) for the requirements). The notification is provided here as required by 7 U.S.C. 1981d.
5 U.S.C. 301 and 7 U.S.C. 1989.
5 U.S.C. 301, 7 U.S.C. 1989 and 25 U.S.C. 488.
The revision reads as follow.
(b) * * *
(15) A description of the requirements for maintaining adequate hazard insurance, workmen's compensation insurance on ultimate recipients, and flood insurance.
(a)
(b)
(c)
(1) First, to those with not less than 10 years of experience serving socially disadvantaged farmers and ranchers that are located in states that have adopted a statute consisting of an enactment or adoption of the Uniform Partition of Heirs Property Act, as approved and recommended for enactment in all States by the National Conference of Commissioners on Uniform State Laws in 2010, that relend to owners of heirs property (as defined by the Uniform Partition of Heirs Property Act);
(2) Second, to those that have applications from ultimate recipients
(3) Multiple applications in the same priority tier, will be processed based by date of application received; and
(4) Any remaining applications, after priority tiers 1 and 2 have been funded as specified in paragraphs (c)(1) and (2) of this section, will be funded in order of the date the application was received.
(d)
(a) * * *
(1) Primary security for HPRP loan will consist of a pledge by the intermediary of all assets now or hereafter placed in the HPRP revolving loan fund, including cash and investments, notes receivable from ultimate recipients, and the intermediary's security interest in collateral pledged by ultimate recipients. A first lien in the intermediary's HPRP revolving loan fund account(s) will be accomplished by a deposit agreement. The deposit agreement with the depository bank will perfect the Agency's security interest in the intermediary's depository accounts. The deposit agreement must be approved by the Agency. The deposit agreement will not require the Agency's signature for withdrawals. The intermediary must use a depository bank that agrees to waive its offset and recoupment rights against the depository account and subordinate any liens it may have against the HPRP depository account in favor of the Agency;
The revisions read as follows:
(d) * * *
(9) * * *
(ii) Any funds that have not been used within 6 months to make loans to an ultimate recipient must be returned to the Agency unless the Agency provides a written exception based on evidence satisfactory to the Agency that funds will be used within an additional 6 months;
(10) All reserves and other cash in the HPRP revolving loan fund must be deposited in accounts in banks or other financial institutions. Such accounts must be fully covered by Federal deposit insurance or the HPRP revolving loan fund must be protected by alternative measures approved by the Agency. The account must be interest-bearing, if feasible, and any interest earned on the account remains a part of the HPRP revolving loan fund; and
5 U.S.C. 301 and 25 U.S.C. 5136.
(b)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA or Agency) is proposing to address the unreasonable risk of injury to human health presented by 1-bromopropane (1-BP) (CASRN 106-94-5), also known as n-propyl bromide, under its conditions of use as documented in EPA's August 2020 Risk Evaluation for 1-BP and the December 2022 Revised Risk Determination for 1-BP prepared under the Toxic Substances Control Act (TSCA). 1-BP is a widely used solvent in a variety of occupational and consumer applications, including vapor degreasing, aerosol degreasing, adhesives and sealants, and in insulation. EPA determined that 1-BP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to 1-BP, including neurotoxicity, developmental toxicity from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. To address the identified unreasonable risk, EPA is proposing requirements to, among other things, prevent consumer access to the chemical, restrict the industrial and commercial use of the chemical while also allowing for a reasonable transition period where an industrial and commercial use of the chemical is being prohibited, and protect workers from the unreasonable risk of 1-BP while on the job.
Comments must be received on or before September 23, 2024. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before September 9, 2024.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0471, through the Federal eRulemaking Portal at
You may be potentially affected by the proposed action if you manufacture (defined under TSCA to include import), process, distribute in commerce, use, or dispose of 1-BP or products containing 1-BP. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities include:
• Crude Petroleum Extraction (NAICS code 211120).
• All Other Specialty Trade Contractors (NAICS code 238990).
• Broadwoven Fabric Mills (NAICS code 313210).
• Nonwoven Fabric Mills (NAICS code 313230).
• Textile and Fabric Finishing Mills (NAICS code 313310).
• Fabric Coating Mills (NAICS code 313320).
• Prefabricated Wood Building Manufacturing (NAICS code 321992).
• Paper Bag and Coated and Treated Paper Manufacturing (NAICS code 322220).
• Commercial Screen Printing (NAICS code 323113).
• Petroleum Refineries (NAICS code 324110).
• All Other Petroleum and Coal Products Manufacturing (NAICS code 324199).
• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).
• All Other Basic Organic Chemical Manufacturing (NAICS code 325199).
• Paint and Coating Manufacturing (NAICS code 325510).
• Adhesive Manufacturing (NAICS code 325520).
• Soap and Other Detergent Manufacturing (NAICS code 325611).
• Polish and Other Sanitation Good Manufacturing (NAICS code 325612).
• Photographic Film, Paper, Plate, and Chemical Manufacturing (NAICS code 325992).
• All Other Miscellaneous Chemical Product and Preparation Manufacturing (NAICS code 325998).
• Polystyrene Foam Product Manufacturing (NAICS code 326140).
• Urethane and Other Foam Product (except Polystyrene) Product Manufacturing (NAICS code 326150).
• Tire Manufacturing (except Retreading) (NAICS code 326211).
• Tire Retreading (NAICS code 326221).
• Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220).
• All Other Rubber Product Manufacturing (NAICS code 326299).
• Other Concrete Product Manufacturing (NAICS code 327390).
• Gypsum Product Manufacturing (NAICS code 327420).
• Cement Manufacturing (NAICS code 327310).
• Iron and Steel Mills and Ferroalloy Manufacturing (NAICS code 331110).
• Iron and Steel Pipe and Tube Manufacturing from Purchased Steel (NAICS code 331210).
• Rolled Steel Shape Manufacturing (NAICS code 332221).
• Steel Wire Drawing (NAICS code 331222).
• Nonferrous Metal (except Aluminum) Smelting and Refining (NAICS code 331410).
• Copper Rolling, Drawing, Extruding, and Alloying (NAICS code 331420).
• Nonferrous Metal (except Copper and Aluminum) Rolling, Drawing, and Extruding (NAICS code 331491).
• Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper and Aluminum) (NAICS code 331492).
• Nonferrous Metal Die-Casting Foundries (NAICS code 331523).
• Iron and Steel Forging (NAICS code 332111).
• Nonferrous Forging (NAICS code 332112).
• Custom Roll Forming (NAICS code 332114).
• Powder Metallurgy Part Manufacturing (NAICS code 332117).
• Metal Crown, Closure, and Other Metal Stamping (except Automotive) (NAICS code 332119).
• Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except Precious) Manufacturing (NAICS code 332215).
• Saw Blade and Handtool Manufacturing (NAICS code 332216).
• Other Fabricated Wire Product Manufacturing (NAICS code 332618).
• Metal Window and Door Manufacturing (NAICS code 332321).
• Machine Shops (NAICS code 332710).
• Precision Turned Product Manufacturing (NAICS code 332721).
• Bolt, Nut, Screw, Rivet, and Washer Manufacturing (NAICS code 332722).
• Industrial Valve Manufacturing (NAICS code 332911).
• Metal Heat Treating (NAICS code 332811).
• Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers (NAICS code 332812).
• Electroplating, Plating, Polishing, Anodizing, and Coloring (NAICS code 332813).
• Industrial Valve Manufacturing (NAICS code 332911).
• Fluid Power Valve and Hose Fitting Manufacturing (NAICS code 332912).
• Plumbing Fixture Fitting and Trim Manufacturing (NAICS code 332913).
• Other Metal Valve and Pipe Fitting Manufacturing (NAICS code 332919).
• Ball and Roller Bearing Manufacturing (NAICS code 332991).
• Small Arms Ammunition Manufacturing (NAICS code 332992).
• Ammunition (except Small Arms) Manufacturing (NAICS code 332993).
• Small Arms, Ordnance, and Ordnance Accessories Manufacturing (NAICS code 332994).
• Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code 332996).
• All Other Miscellaneous Fabricated Metal Product Manufacturing (NAICS code 332999).
• Other Industrial Machinery Manufacturing (NAICS code 333249).
• Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS code 333415).
• Special Die and Tool, Die Set, Jig, and Fixture Manufacturing (NAICS code 333514).
• Cutting Tool and Machine Tool Accessory Manufacturing (NAICS code 333515).
• Speed Changer, Industrial High-Speed Drive, and Gear Manufacturing (NAICS code 333612).
• Air and Gas Compressor Manufacturing (NAICS code 333912).
• Measuring, Dispensing, and Other Pumping Equipment Manufacturing (NAICS code 333914).
• Elevator and Moving Stairway Manufacturing (NAICS code 333921).
• Conveyor and Conveying Equipment Manufacturing (NAICS code 333922).
• Overhead Traveling Crane, Hoist, and Monorail System Manufacturing (NAICS code 333923).
• Industrial Process Furnace and Oven Manufacturing (NAICS code 333924).
• Power-Driven Handtool Manufacturing (NAICS code 333991).
• Welding and Soldering Equipment Manufacturing (NAICS code 333992).
• Packaging Machinery Manufacturing (NAICS code 333993).
• Industrial Process Furnace and Oven Manufacturing (NAICS code 333994).
• Fluid Power Cylinder and Actuator Manufacturing (NAICS code 333995).
• Fluid Power Pump and Motor Manufacturing (NAICS code 333996).
• All Other Miscellaneous General Purpose Machinery Manufacturing (NAICS code 333998).
• Audio and Video Equipment Manufacturing (NAICS code 334310).
• Capacitor, Resistor, Coil, Transformer, and Other Inductor Manufacturing (NAICS code 334416).
• Electronic Connector Manufacturing (NAICS code 334417).
• Printed Circuit Assembly (Electronic Assembly) Manufacturing (NAICS code 334418).
• Other Electronic Component Manufacturing (NAICS code 334419).
• Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing (NAICS code 334511).
• Automatic Environmental Control Manufacturing for Residential, Commercial, and Appliance Use (NAICS code 334512).
• Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (NAICS code 334513).
• Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals (NAICS code 334515).
• Residential Electric Lighting Fixture Manufacturing (NAICS code 335131).
• Commercial, Industrial, and Institutional Electric Lighting Fixture Manufacturing (NAICS code 335132).
• Electric Lamp Bulb and Other Lighting Equipment Manufacturing (NAICS code 335139).
• Power, Distribution, and Specialty Transformer Manufacturing (NAICS code 335311).
• Motor and Generator Manufacturing (NAICS code 335312).
• Switchgear and Switchboard Apparatus Manufacturing (NAICS code 335313).
• Relay and Industrial Control Manufacturing (NAICS code 335314).
• Fiber Optic Cable Manufacturing (NAICS code 335921).
• Current-Carrying Wiring Device Manufacturing (NAICS code 335931).
• Carbon and Graphite Product Manufacturing (NAICS code 335991).
• Automobile and Light Duty Motor Vehicle Manufacturing (NAICS code 336110).
• Heavy Duty Truck Manufacturing (NAICS code 336120).
• Motor Vehicle Body Manufacturing (NAICS code 336211).
• Truck Trailer Manufacturing (NAICS code 336212).
• Motor Home Manufacturing (NAICS code 336213).
• Travel Trailer and Camper Manufacturing (NAICS code 336214).
• Motor Vehicle Gasoline Engine and Engine Parts Manufacturing (NAICS code 336310).
• Motor Vehicle Electrical and Electronic Equipment Manufacturing (NAICS code 336320).
• Motor Vehicle Steering and Suspension Components (except Spring) Manufacturing (NAICS code 336330).
• Motor Vehicle Brake System Manufacturing (NAICS code 336340).
• Motor Vehicle Transmission and Power Train Parts Manufacturing (NAICS code 336350).
• Motor Vehicle Seating and Interior Trim Manufacturing (NAICS code 336360).
• Motor Vehicle Metal Manufacturing (NAICS code 336370).
• Other Motor Vehicle Parts Manufacturing (NAICS code 336390).
• Aircraft Manufacturing (NAICS code 336411).
• Aircraft Engine and Engine Parts Manufacturing (NAICS code 336412).
• Other Aircraft Parts and Auxiliary Equipment Manufacturing (NAICS code 336413).
• Guided Missile and Space Vehicle Manufacturing (NAICS code 336414).
• Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit Parts Manufacturing (NAICS code 336415).
• Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment Manufacturing (NAICS code 336419).
• Railroad Rolling Stock Manufacturing (NAICS code 336510).
• Ship Building and Repairing (NAICS code 336611).
• Wood Kitchen Cabinet and Countertop Manufacturing (NAICS code 337110).
• Upholstered Household Furniture Manufacturing (NAICS code 337121).
• Nonupholstered Wood Household Furniture Manufacturing (NAICS code 337122).
• Institutional Furniture Manufacturing (NAICS code 337127).
• Wood Office Furniture Manufacturing (NAICS code 337211).
• Surgical Appliance and Supplies Manufacturing (NAICS code 339113).
• Dental Equipment and Supplies Manufacturing (NAICS code 339114).
• Jewelry and Silverware Manufacturing (NAICS code 339910).
• Sporting and Athletic Goods Manufacturing (NAICS code 339920).
• Gasket, Packing, and Sealing Device Manufacturing (NAICS code 339991).
• Fastener, Button, Needle, and Pin Manufacturing (NAICS code 339993).
• All Other Miscellaneous Manufacturing (NAICS code 339999).
• Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510).
• Industrial Machinery and Equipment Merchant Wholesalers (NAICS code 423830).
• Drugs and Druggists' Sundries Merchant Wholesalers (NAICS code 424210).
• Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690).
• New Car Dealers (NAICS code 441110).
• Used Car Dealers (NAICS code 441120).
• Home Centers (NAICS code 444110).
• Paint and Wallpaper Stores (NAICS code 444120).
• Electronics and Appliance Retailers (NAICS code 449210).
• Sporting Goods Stores (NAICS code 459110).
• Scheduled Passenger Air Transportation (NAICS code 481111).
• Other Support Activities for Air Transportation (NAICS code 488190).
• Other Warehousing and Storage (NAICS code 493190).
• Miscellaneous Intermediation (NAICS code 523910).
• Portfolio Management and Investment Advice (NAICS code 523940).
• Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (NAICS code 541715).
• Research and Development in the Social Sciences and Humanities (NAICS code 541720).
• Janitorial Services (NAICS code 561720).
• Carpet and Upholstery Cleaning Services (NAICS code 561740).
• Hazardous Waste Treatment and Disposal (NAICS code 562211).
• Junior Colleges (NAICS code 611210).
• Colleges, Universities, and Professional Schools (NAICS code 611230).
• General Automotive Repair (NAICS code 811111).
• Specialized Automotive Repair (NAICS code 811114).
• Automotive Body, Paint, and Interior Repair and Maintenance (NAICS code 811121).
• Automotive Glass Replacement Shops (NAICS code 811122).
• Automotive Oil Change and Lubrication Shops (NAICS code 811191).
• All Other Automotive Repair and Maintenance (NAICS code 811198).
• Other Electronic and Precision Equipment Repair and Maintenance (NAICS code 811210).
• Commercial and Industrial Machinery and Equipment (except Automotive and Electronic) Repair and Maintenance (NAICS code 811310).
• Home and Garden Equipment Repair and Maintenance (NAICS code 811411).
• Other Personal and Household Goods Repair and Maintenance (NAICS code 811490).
• Coin-Operated Laundries and Drycleaners (NAICS code 812310).
• Drycleaning and Laundry Services (except Coin-Operated) (NAICS code 812320).
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance in bulk form, as part of a mixture, or as part of an article (if required by rule) are subject to TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk.
Pursuant to TSCA section 6(b), EPA determined that 1-BP presents an unreasonable risk of injury to health, without consideration of costs or other nonrisk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations (PESS) and susceptible life stages identified as relevant to the 2020 Risk Evaluation for 1-BP by EPA, under the conditions of use (Refs. 1, 2). The term “conditions of use” is defined at TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the circumstances under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. A detailed description of the conditions of use that EPA identified, evaluated and determined to contribute to EPA's determination that 1-BP presents an unreasonable risk is included in Unit III.B.1. EPA notes that all conditions of use of 1-BP (excluding the commercial and consumer use of 1-BP in insulation) are subject to this proposal. Accordingly, to address the unreasonable risk, EPA is proposing, under TSCA section 6(a), to:
(i) Prohibit the manufacture (including import), processing, and distribution in commerce of 1-BP for all consumer uses (excluding insulation for building and construction materials), outlined in Unit IV.A.1.;
(ii) Prohibit the manufacture (including import), processing and distribution in commerce of 1-BP for four industrial and commercial uses, outlined in Unit IV.A.1.;
(iii) Require strict workplace controls, including a 1-BP Workplace Chemical Protection Program (WCPP), which would include requirements to meet an inhalation exposure concentration limit,
(iv) Require the use of prescriptive controls for six occupational conditions of use of 1-BP, outlined in Unit IV.A.3.;
(v) Require purchasers to provide sellers with a self-certification, which would document the purchaser's commitment to comply with the 1-BP WCPP, for six occupational conditions of use of 1-BP, outlined in Unit IV.A.2.; and
(vi) Establish recordkeeping and downstream notification requirements outlined in Unit IV.A.4.
In addition, in each of the proposed rules under TSCA section 6(a), EPA is proposing to amend the general provisions of 40 CFR 751, subpart A, to define “ECEL,” and “exposure group,” so that these definitions may be commonly applied to this and other rules under TSCA section 6 that would be codified in 40 CFR part 751. EPA seeks public comment on all aspects of this proposed rule.
Under TSCA section 6(a), “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the [section 6(a)] requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk.” 1-BP was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in August 2020 (Ref. 1). In addition, EPA issued a revised unreasonable risk determination in December 2022 (Ref. 2), determining that 1-BP, as a whole chemical substance, presents an unreasonable risk of injury to health under the conditions of use. As a result, EPA is proposing to take action to the extent necessary so that 1-BP no longer presents such risk. The unreasonable risk is described in Unit III.B.2. and the conditions of use that contribute to the unreasonable risk for 1-BP are described in Unit III.B.1.
1-BP's hazards are well established. EPA's 2020 Risk Evaluation for 1-BP considered the hazards associated with exposure to 1-BP and determined that 1-BP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to 1-BP. While some of the risks of adverse effects from 1-BP exposure may be acute and experienced for only a short duration, other health risks may be chronic and result in long-term impacts that are irreversible (
EPA is not proposing a complete ban on 1-BP. This rule proposes to allow certain uses of 1-BP to continue provided that sufficient worker protections are in place to address the unreasonable risk for certain occupational conditions of use. For the conditions of use for which EPA is proposing strict workplace controls under a WCPP, EPA expects that many workplaces already have stringent controls in place that reduce exposures to 1-BP; for some workplaces, such as those using 1-BP in vapor degreasing, EPA understands that these existing controls may already reduce exposure enough to meet the inhalation exposure concentration limit proposed in this rulemaking (Ref. 1).
Accordingly, EPA is proposing strict workplace controls to address the unreasonable risk and to allow continued use of 1-BP for several conditions of use, including processing for incorporation into formulation, mixture, or reaction products; use in vapor degreasing; use in cold cleaning; use in aerosol spray degreasers/cleaners; use in electronic and electronic products and metal products; use in asphalt extraction and laboratory chemicals; processing as a reactant/intermediate; and use in coatings for temperature indicators, which, in total, comprise an estimated 97% of the current production volume of 1-BP. EPA is proposing to prohibit certain conditions of use of 1-BP, including manufacture (including import), processing, and distribution in commerce of 1-BP for all consumer use, excluding the use of 1-BP in insulation; use in dry cleaning and spot cleaning, adhesives and sealants, liquid cleaners, automotive care products, anti-adhesive agents, functional fluids, and arts, crafts, and hobby materials, comprising an estimated 3% of the current production volume of 1-BP. Unit IV.A. describes EPA's proposed regulatory action and Unit IV.B. describes the alternative regulatory actions considered as required under TSCA section 6(c)(2)(A). The rationale for the proposed regulatory action and alternative regulatory actions, including what is feasible and appropriate for each condition of use, is described in Unit V., and the TSCA section 6 requirements considered in developing the regulatory actions are described in Unit III.B.3.
EPA has prepared an Economic Analysis (EA) of the potential incremental impacts associated with this rulemaking that can be found in the rulemaking docket and is briefly summarized here (Ref. 3). The cost of the proposed rule is estimated to be $14.8 million annualized over 20 years at a 3% discount rate and $15.5 million annualized over 20 years at a 7% discount rate. These costs take compliance with implementation of a WCPP into consideration, which would include an existing chemical exposure limit (ECEL) of 0.05 ppm (0.25 mg/m3) for inhalation exposures as an 8-hour time-weighted average (TWA), applicable personal protective equipment (PPE) requirements, and reformulation costs of numerous products. The estimates discussed in the preamble reflect the central estimates for the number of sites and workers affected rather than the low- or high-end estimates. The sensitivity analysis in Chapter 11 presents the estimated costs, benefits, and net benefits for low, central, and high estimates of affected sites, workers, and occupational non-users (ONUs). The economic impact on users of 1-BP for vapor degreasing is unclear because some users may not be able to continue using their current equipment (open-top vapor degreasers). Based on engagement with industry, including public comments received on the draft risk evaluation and draft revised unreasonable risk determination for 1-BP, EPA expects workplaces engaged in vapor degreasing to have the ability to implement a WCPP that would include an ECEL, PPE requirements, and ancillary requirements. EPA estimates
The actions proposed in this rulemaking are expected to achieve health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot be monetized. The monetized benefits of this rulemaking are approximately $27.2 million annualized over 20 years at a 3% discount rate and $12.9 million annualized over 20 years at a 7% discount rate. The monetized benefits include potential reductions in risk of colon and lung cancers. Non-monetized benefits include risk reduction of liver toxicity, kidney toxicity, reproductive toxicity, developmental toxicity, and neurotoxicity (peripheral neuropathy) (Ref. 3).
As described in more detail in the Economic Analysis, the Agency analyzed the demographic characteristics of several populations that would be impacted by this rulemaking (Ref. 3). In general, workers in affected industries and regions, as well as residents of nearby communities, are similar to workers and residents nationwide. Data limitations prevent EPA from conducting a more comprehensive environmental justice (EJ) analysis that would identify the incremental impacts of the regulatory options and assess the extent to which they mitigate or exacerbate any disproportionate impacts in communities with EJ concerns.
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This proposed rule applies to 1-BP (CASRN 106-94-5) and is specifically intended to address the unreasonable risk of injury to health EPA has identified in the 2020 Risk Evaluation for 1-BP and the 2022 revised unreasonable risk determination, as described in Unit III.B.2. 1-BP is a colorless, volatile liquid with a mildly sweet odor that is produced in and imported into the United States. 1-BP is manufactured, processed, distributed, used, and disposed of as part of many industrial, commercial, and consumer conditions of use.
As outlined in further detail in Unit III.B.1., 1-BP is used as a solvent in cleaning and degreasing operations (including vapor degreasing, cold cleaning, and aerosol degreasing), spray adhesives, and dry cleaning. 1-BP is also used as a reactant in the manufacturing of other chemical substances. Consumer uses of 1-BP include aerosol degreasers, spot cleaners, and stain removers. 1-BP is also used in insulation for building and construction materials. According to data submitted for the 2016 submission period under EPA's Chemical Data Reporting (CDR) rule, the total aggregate annual production volume of 1-BP in the U.S. increased from 15.4 million pounds to 25.8 million pounds between 2012 and 2015 (Ref. 4). The total aggregate annual production volume ranged from 1 to 50 million pounds between 2016 and 2019 according to CDR (Ref. 5).
Because of its adverse health effects, 1-BP is subject to several Federal laws and regulations in the United States and is also subject to regulation by some States and other countries. A summary of EPA regulations pertaining to 1-BP, as well as other Federal, state, and international regulations, is in the docket and in Appendix A of the 2020 Risk Evaluation for 1-BP (Refs. 6, 1). EPA acknowledges that additional 1-BP regulatory steps occurred after 2020, including the addition of 1-BP as a Hazardous Air Pollutant (HAP) to the Clean Air Act list in January 2022, as discussed in Unit X.C.5.
Although EPA must consider and factor in, to the extent practicable, certain non-risk factors as part of TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still ensure that the selected regulatory requirements apply “to the extent necessary so that the chemical substance or mixture no longer presents [unreasonable] risk.” 15 U.S.C. 2605(a). This requirement to eliminate unreasonable risk is distinguishable from approaches mandated by some other laws, including the Occupational Safety and Health Act (OSH Act), which includes both significant risk and feasibility (technical and economic) considerations in the setting of standards.
Congress intended for EPA to consider occupational risks from chemicals it evaluates under TSCA, among other potential exposures, as relevant and appropriate. As noted previously, section 6(b) of TSCA requires EPA to evaluate risks to PESS identified as relevant by the Administrator. TSCA section 3(12) defines the term “potentially exposed or susceptible subpopulation” as “a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.”
The OSH Act similarly requires OSHA to evaluate risk specific to workers prior to promulgating new or revised standards and requires OSHA standards to substantially reduce significant risk to the extent feasible, even if workers are exposed over a full working lifetime.
Thus, the standards for chemical hazards that OSHA promulgates under the OSH Act share a broadly similar purpose with the standards that EPA promulgates under TSCA section 6(a). The control measures OSHA and EPA require to satisfy the objectives of their respective statutes may also, in many circumstances, overlap or coincide. However, as this section outlines, there
OSHA's mission is to ensure that employees work in safe and healthful conditions. The OSH Act establishes requirements that each employer comply with the General Duty Clause of the Act (29 U.S.C. 654(a)), as well as with occupational safety and health standards issued under the Act.
The General Duty Clause of the OSH Act requires employers to keep their workplaces free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees. The General Duty Clause is cast in general terms, and does not establish specific requirements like exposure limits, PPE, or other specific protective measures that EPA could potentially consider when developing its risk evaluations or risk management requirements. OSHA, under limited circumstances, has cited the General Duty Clause for regulating exposure to chemicals. To prove a violation of the General Duty Clause, OSHA must prove employer or industry recognition of the hazard, the hazard was causing or likely to cause death or serious physical harm, and a feasible method to eliminate or materially reduce the hazard was available. In rare situations, OSHA has cited employers for violation of the General Duty Clause where exposures were below a chemical-specific permissible exposure limit (PEL), a TWA based on an employee's average airborne exposure in any 8-hour work shift of a 40-hour work week which shall not be exceeded (Ref. 7). In such situations, OSHA must demonstrate that the employer had actual knowledge that the PEL was inadequate to protect its employees from death or serious physical harm. Because of the heavy evidentiary burden on OSHA to establish violations of the General Duty Clause, it is not frequently used to cite employers for employee exposure to chemical hazards.
OSHA standards are issued pursuant to the OSH Act and are found in title 29 of the CFR. There are separate standards for general industry, laboratories, construction, maritime and agriculture sectors, and general standards applicable to a number of sectors (
OSHA sets legally enforceable limits on the airborne concentrations of hazardous chemicals, referred to as PELs, established for employers to protect their workers against the health effects of exposure to hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act, OSHA was permitted an initial 2-year window after the passage of the Act to adopt “any national consensus standard and any established Federal standard.” 29 U.S.C. 655(a). OSHA used this authority in 1971 to establish PELs that were adopted from Federal health standards originally set by the Department of Labor through the Walsh-Healy Act, in which approximately 400 occupational exposure limits (OELs) were selected based on the American Conference of Governmental Industrial Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In addition, about 25 exposure limits recommended by the American Standards Association (now called the American National Standards Institute (ANSI) were adopted as PELs.
Following the 2-year window provided under section 6(a) of the OSH Act for adoption of national consensus and existing Federal standards, OSHA has issued health standards following the requirements in section 6(b) of the Act. OSHA has established approximately 30 PELs under section 6(b)(5) as part of comprehensive substance-specific standards that include additional requirements for protective measures such as use of PPE, establishment of regulated areas, exposure assessment, hygiene facilities, medical surveillance, and training. These ancillary provisions in substance-specific OSHA standards further mitigate residual risk that could be present due to exposure at the PEL.
OSHA has not established a PEL for 1-BP and for those it has, in many instances, scientific evidence has accumulated suggesting that the current limits of many PELs are not sufficiently protective. Unlike EPA's requirements under TSCA to address unreasonable risk, health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only to the extent that it is technologically and economically feasible. OSHA's legal requirement to demonstrate that its section 6(b)(5) standards are technologically and economically feasible at the time they are promulgated often precludes OSHA from imposing exposure control requirements sufficient to ensure that the chemical substance no longer presents a significant risk to workers.
TSCA section 6(b) unreasonable risk determinations may account for unreasonable risk to more sensitive endpoints and working populations than OSHA's risk evaluations typically contemplate, and EPA is obligated to apply TSCA section 6(a) risk management requirements to the extent necessary so that the unreasonable risk is no longer presented.
Because the requirements and application of TSCA and OSHA regulatory analyses differ, it is necessary for EPA to conduct risk evaluations and, where it finds unreasonable risk to workers, develop risk management requirements for chemical substances that OSHA also regulates, and it is expected that EPA's findings and requirements may sometimes diverge from OSHA's. However, it is also appropriate that EPA consider the chemical standards that OSHA has already developed to limit the compliance burden to employers by aligning management approaches required by the agencies, where alignment will adequately address unreasonable risk to workers. The following section discusses EPA's consideration of OSHA standards in its risk evaluation and management strategies under TSCA.
When characterizing the risk during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where no mitigation measures are assumed to be in place for the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It should be noted that there are some cases where scenarios may reflect certain mitigation measures, such as in instances where exposure estimates are based on monitoring data at facilities that have existing engineering controls in place.)
In addition, EPA believes it may be appropriate to also evaluate the levels of risk present in scenarios considering applicable OSHA requirements as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. EPA may evaluate risk
When making unreasonable risk determinations as part of TSCA risk evaluations, EPA cannot assume as a general matter that all workers are always equipped with and appropriately using sufficient PPE, although it does not question the veracity of public comments received on the 2020 Risk Evaluation for 1-BP regarding the occupational safety practices often followed by industry respondents. When characterizing the risk to human health from occupational exposures during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in scenarios where PPE is not assumed to be used by workers. This approach of not assuming PPE use by workers considers the risk to PESS (workers and occupational non-users (ONUs)) who may not be covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan. Mitigation scenarios included in the EPA risk evaluation in order to inform its risk management efforts (
Therefore, EPA makes its determinations of unreasonable risk based on scenarios that do not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. Making unreasonable risk determinations based on such scenarios should not be viewed as an indication that EPA believes there are no occupational safety protections in place at any location, or that there is widespread noncompliance with applicable OSHA standards. Rather, it reflects EPA's recognition that unreasonable risk may exist: (1) for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by an OSHA State Plan; (2) because EPA finds unreasonable risk for purposes of TSCA notwithstanding existing OSHA requirements.
In addition to the scenarios described previously, EPA risk evaluations may characterize the levels of risk present in scenarios considering applicable OSHA requirements (
When undertaking risk management actions, EPA: (1) Develops occupational risk mitigation measures to address any unreasonable risk identified by EPA, striving for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls (Ref. 8), when those measures would address an unreasonable risk; and (2) Ensures that EPA requirements apply to all potentially exposed workers in accordance with TSCA requirements. Consistent with TSCA section 9(d), EPA consults and coordinates TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum applicability of TSCA while avoiding the imposition of duplicative requirements.
Informed by the mitigation scenarios and information gathered during the risk evaluation and risk management process, the Agency might propose rules that require risk management practices that may be already common practice in many or most facilities. Adopting clear, broadly applicable regulatory standards will foster compliance across all facilities (ensuring a level playing field) and assure protections for all affected workers, especially in cases where current OSHA standards may not apply to them or not be sufficient to address the unreasonable risk.
EPA incorporated the considerations described earlier in this unit in the 2020 Risk Evaluation for 1-BP, the December 2022 revised unreasonable risk determination for 1-BP, and this proposed risk management rulemaking. Specifically, in the TSCA 2020 Risk Evaluation for 1-BP, EPA presented risk estimates based on workers' exposures with and without respiratory protection. EPA determined that even when respirators with APF 50 are used by workers, most of the conditions of use evaluated presented an unreasonable risk. Additional consideration of OSHA standards in the revised unreasonable risk determination is discussed further in the
In accordance with the approach described earlier in Unit II.C.3., EPA intends for this regulation to be as consistent as possible with the existing OSHA standards, with additional requirements as necessary to address the unreasonable risk. One notable difference between the WCPP and the OSHA standards are the exposure limits. The WCPP would include an ECEL of 0.05 ppm as an 8-hour TWA to address unreasonable risks for chronic cancer and non-cancer and acute non-
The TSCA ECEL value for 1-BP is a lower value than other existing OELs, discussed in Unit II.C.5., because many of those OELs are outdated, and they may not fully capture either the complete database of studies considered in the 2020 Risk Evaluation for 1-BP or more recent advances in modeling and scientific interpretation of toxicological data applied in the calculation of the 1-BP ECEL. EPA considers the 1-BP ECEL to represent the best available science under TSCA section 26(h) because it was derived from information in the 2020 Risk Evaluation for 1-BP, which was subject to peer review, and which is the result of a systematic review approach that investigated the reasonably available information in order to identify relevant adverse health effects. Additionally, by using the information from the 2020 Risk Evaluation for 1-BP, the ECEL incorporates advanced modeling and peer-reviewed methodologies, and accounts for exposures to potentially exposed or susceptible subpopulations, as required by TSCA.
For 1-BP, the TSCA ECEL is an 8-hour occupational inhalation exposure limit based on cancer inhalation risks and takes into consideration the uncertainties identified in the 2020 Risk Evaluation for 1-BP (Ref. 12). The ECEL represents the concentration at which an adult human, including a member of a PESS, would be unlikely to suffer adverse effects if exposed for a working lifetime. EPA has determined as a matter of risk management policy that ensuring exposures remain at or below the ECEL will eliminate any unreasonable risk of injury to health from occupational inhalation exposures. In addition to the ECEL, as part of this rulemaking, EPA is proposing an ECEL action level. An ECEL action level, similar to other OEL frameworks, is typically a value lower than the ECEL value, that would trigger additional monitoring to ensure that workers are not exposed to concentrations above the ECEL.
For 1-BP, the ECEL of 0.05 ppm is based on the cancer endpoints. As demonstrated in the ECEL memo, cancer from chronic inhalation exposures is the basis of the 1-BP ECEL (Ref. 12). As discussed in Units II.D., III.B., and VII.D., the TSCA ECEL represents the best available science at time of publication of the 2020 Risk Evaluation for 1-BP.
EPA is aware of other OELs for 1-BP, including the California Division of Occupational Safety and Health (Cal/OSHA) PEL and the ACGIH TLV. The 2014 8-hour TWA TLV recommended by the ACGIH is 0.10 ppm. This TLV is based on the potential for neurotoxicity, liver toxicity, and reproductive/developmental toxicity. While a variety of studies covering numerous health effects are discussed in the report, the most relevant study cited (Ref. 13) reported “diminished vibration sensation and lower scores in memory and mood tests” in workers at measured occupational exposures as low as 0.34 ppm. The TLV appears to be semi-quantitative and not directly extrapolated from any individual point of departure. The August 2020 TSCA Risk Evaluation for 1-BP discussed the Ichihara results (Ref. 1, 13), however they were considered ambiguous due to 1-BP co-exposures that may have significantly contributed to the observed neurotoxicity. The TLV report also discusses the NTP 2011 cancer results that were the basis of the TSCA ECEL, however linear low-dose extrapolation was not performed in order to derive a lower TLV.
The 2014 Cal/OSHA PEL is 5 ppm, higher than the ACGIH TLV, and has a skin notation, meaning that a worker's skin, eyes and mouth should be protected from any contact with 1-BP (Ref. 14). The Cal/OSHA PEL is based on reproductive and developmental toxicity (observed in animal studies) and technological feasibility assessments from industry (Ref. 14).
In December 2016, EPA selected 1-BP as one of the first 10 chemicals for risk evaluation under TSCA section 6 (Ref. 15). EPA published the scope of the 1-BP risk evaluation in June 2017 (82 FR 31592, July 7, 2017), and, after receiving public comments, published the problem formulation in June 2018 (83 FR 26998, June 11, 2018). In August 2019, EPA published a draft risk evaluation (84 FR 39830, August 12, 2019), and, after public comment and peer review by the Science Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk Evaluation for 1-BP in August 2020 in accordance with TSCA section 6(b) (85 FR 48687, August 12, 2020). EPA subsequently issued a draft revised TSCA unreasonable risk determination for 1-BP (87 FR 43265, July 20, 2022), and after public notice and receipt of comments, published a revised Unreasonable Risk Determination for 1-BP (87 FR 77603, December 2022). The 2020 Risk Evaluation for 1-BP and supplemental materials are in docket EPA-HQ-OPPT-2019-0235, with the December 2022 revised unreasonable risk determination and additional materials supporting the risk evaluation process are in docket EPA-HQ-OPPT-2016-0741, on
In the 2020 Risk Evaluation for 1-BP, EPA evaluated risks associated with 25 conditions of use within the following categories: manufacture (including import), processing, distribution in commerce, industrial and commercial use, consumer use, and disposal. Descriptions of these conditions of use are in Unit III.B.1. The 2020 Risk Evaluation for 1-BP identified significant adverse health effects associated with exposure to 1-BP, including developmental toxicity from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to 1-BP. A further discussion of the hazards of 1-BP is included in Unit III.B.2.
EPA has been revisiting specific aspects of its first ten TSCA existing chemical risk evaluations, including the 2020 Risk Evaluation for 1-BP, to ensure that the risk evaluations upon which risk management decisions are made better align with TSCA's objective of protecting human health and the environment. For 1-BP, EPA revised the original unreasonable risk determination based on the 2020 Risk Evaluation for 1-BP and issued a final revised unreasonable risk determination on December 2022 (Ref. 2). EPA revised the risk determination for the 2020 Risk Evaluation for 1-BP pursuant to TSCA section 6(b) and consistent with Executive Order 13990, (“Protecting Public Health and the Environment and Restoring Science to Tackle the Climate
In determining whether 1-BP presents unreasonable risk under the conditions of use, EPA considered relevant risk-related factors, including, but not limited to: the effects of the chemical substance on health (including cancer and non-cancer risks) and human exposure to the substance under the conditions of use (including duration, magnitude, and frequency of exposure); the effects of the chemical substance on the environment and environmental exposure under the conditions of use; the population exposed (including any PESS); susceptible life stages; the severity of hazard (including the nature of the hazard, the irreversibility of the hazard); and uncertainties.
EPA determined that 1-BP presents an unreasonable risk of injury to health. The contributions to the unreasonable risk determination are risks to workers and ONUs (workers who do not directly handle the chemical but perform work in an area where the chemical is present) due to occupational exposures to 1-BP (
While the 2020 Risk Evaluation for 1-BP estimated different risks for occupational non-users and workers, the benchmark (and thus the ECEL value) is the same for both populations. That is, while workers and occupational non-users may have different exposure patterns, the level of exposure such that risks are no longer unreasonable is the same for both workers and occupational non-users. Thus, for the purposes of risk management, the distinction between worker and occupational non-user is no longer relevant, and both are encompassed by the proposed definition of a potentially exposed person, as outlined in Unit IV.A.2.a. EPA notes that this proposed definition is intended to apply to occupational workplaces as part of implementation of the WCPP, and recognizes that other individuals or communities may be exposed to 1-BP as consumers, members of fenceline communities, or members of the general population.
The 2020 TSCA Risk Evaluation for 1-BP excluded the assessment of certain exposure pathways that were or could be regulated under another EPA-administered statute (see section 1.4.2 of the August 2020 Risk Evaluation for 1-BP (Refs. 1, 2). This resulted in the ambient air pathway for 1-BP exposure not being fully assessed for human health risk to the general population. The August 2020 Risk Evaluation for 1-BP did assess the water pathway based on fate and monitoring and modeling data, which determined there was no presence of 1-BP (Ref. 1). In June 2021, EPA made a policy announcement on the path forward for TSCA chemical risk evaluations, indicating that EPA would, among other things, examine whether the exclusion of certain exposure pathways from the risk evaluations could lead to a failure to identify and protect fenceline communities (Refs. 9; 15). EPA then conducted a screening analysis to identify whether there may be potential risks to people living near the fenceline of facilities releasing 1-BP.
In order to determine whether there may be potential risk to the general population in proximity to a facility releasing 1-BP, EPA developed the TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0, which was presented to the SACC in March 2022, with a report issued by the SACC on May 18, 2022 (Ref. 19). This analysis is discussed in Unit VI.A.
Under TSCA section 6(a), if the Administrator determines, through a TSCA section 6(b) risk evaluation that the manufacture (including import), processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of such activities, presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more of the following requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk.
• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture, or limit the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce (section 6(a)(1)).
• Prohibit or otherwise restrict the manufacturing, processing, or distribution in commerce of the substance or mixture for a particular use or above a specific concentration for a particular use (section 6(a)(2)).
• Limit the amount of the substance or mixture which may be manufactured, processed, or distributed in commerce for a particular use or above a specific concentration for a particular use specified (section 6(a)(2)).
• Require clear and adequate minimum warning and instructions with respect to the substance or mixture's use, distribution in commerce, or disposal, or any combination of those activities, to be marked on or accompanying the substance or mixture (section 6(a)(3)).
• Require manufacturers and processors of the substance or mixture to make and retain certain records or conduct certain monitoring or testing (section 6(a)(4)).
• Prohibit or otherwise regulate any manner or method of commercial use of the substance or mixture (section 6(a)(5)).
• Prohibit or otherwise regulate any manner or method of disposal of the substance or mixture, or any article containing such substance or mixture, by its manufacturer or processor or by any person who uses or disposes of it for commercial purposes (section 6(a)(6)).
• Direct manufacturers or processors of the substance or mixture to give notice of the unreasonable risk determination to distributors, certain other persons, and the public, and to replace or repurchase the substance or mixture (section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section 6(a) requirements could be applied to address the unreasonable risk found to be present in the 2020 Risk Evaluation for 1-BP and the final revised unreasonable risk determination, so that 1-BP no longer presents such
Under the authority of TSCA section 6(g), EPA may consider granting a time-limited exemption from a requirement of a TSCA section 6(a) rule for a specific condition of use if EPA finds that: (1) The specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; (2) Compliance with the requirement, as applied with respect to the specific condition of use would significantly disrupt the national economy, national security, or critical infrastructure; or (3) The specific condition of use, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. At this time, EPA is not proposing to grant TSCA section 6(g) exemptions in this proposed rulemaking.
TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section 6(a) rules, to consider and include a statement addressing certain factors, including the costs and benefits and the cost effectiveness of the regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator. A description of all TSCA section 6 requirements considered in developing this proposed regulatory action is in Unit III.B.3., and Unit V.B. includes more information regarding EPA's consideration of exemptions and alternatives. TSCA section 6(c)(2)(C) requires that in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use and in setting an appropriate transition period for such action, EPA consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as substitutes when the proposed prohibition or restriction takes effect. Unit IV.B. includes more information regarding EPA's consideration of alternatives, and Unit VI. provides more information on EPA's considerations more broadly under TSCA section 6(c)(2).
EPA carried out required consultations as described in this unit and also considered impacts on children's environmental health as part of its approach to developing this TSCA section 6 regulatory action.
EPA conducted consultations and outreach in developing this proposed regulatory action. The Agency held a federalism consultation from October 22, 2020, until January 23, 2021, as part of this rulemaking process and pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999). This included a background presentation on September 9, 2020, and a consultation meeting on October 22, 2020. During the consultation, EPA met with State and local officials early in the process of developing the proposed action in order to receive meaningful and timely input into its development (Ref. 20). During the consultation, participants and EPA discussed preemption, EPA's authority under TSCA section 6 to regulate identified unreasonable risks, what activities would be potentially regulated in the proposed rule; and the relationship between TSCA and existing statutes—particularly the Clean Air Act (CAA) (Ref. 20).
1-BP is not manufactured (including imported), processed, distributed in commerce, or regulated by Tribal governments. However, EPA consulted with Tribal officials during the development of this proposed action (Ref. 21). The Agency held a Tribal consultation from October 7, 2020, to January 8, 2021, with meetings on November 12 and 17, 2020. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. During the consultation, EPA discussed risk management under TSCA section 6(a), findings from the 2020 Risk Evaluation for 1-BP, types of information that would be helpful to inform risk management, principles for transparency during the risk management process, and types of information EPA is seeking from tribes (Ref. 21). EPA received no written comments as part of this consultation.
In addition to the formal consultations, EPA also conducted outreach to advocates of communities that might be subject to disproportionate risk from the exposures to 1-BP, such as low-income populations, and indigenous peoples. EPA's Environmental Justice (EJ) consultation occurred from November 4, 2020, through January 18, 2021. On November 16 and 19, 2020, EPA held public meetings as part of this consultation. These meetings were held pursuant to EPA policy to advance meaningful community engagement as part of the goal of environmental justice. During the consultations, participants and EPA discussed risk management under TSCA section 6(a), types of information that would be helpful to inform risk management, principles for transparency during the risk management process, and the relationship between TSCA and existing statutes, particularly the Clean Air Act. In general, commenters supported strong regulation of 1-BP to protect lower-income communities and workers. Commenters also supported strong outreach to affected communities, encouraged EPA to follow the NIOSH hierarchy of controls in regulating 1-BP, favored prohibitions, and noted the uncertainties associated with use of personal protective equipment (
As required by section 609(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601
Units X.C., X.E., X.F., and X.J. provide more information regarding the consultations.
In addition to the formal consultations described in Unit X., EPA held a webinar on September 30, 2020, providing an overview of the TSCA risk management process and the risk evaluation findings for 1-BP. EPA also presented on the risk evaluation and risk management under TSCA for 1-BP at a Small Business Administration (SBA) Office of Advocacy Environmental roundtable on September 11, 2020. At both events EPA staff provided an overview of the TSCA risk management process and the findings in the 2020 Risk Evaluation for 1-BP (Ref. 25). Attendees of these meetings were given an opportunity to voice their concerns regarding the risk evaluation and risk management.
Furthermore, EPA engaged in discussions with representatives from different industries, non-governmental organizations, technical experts and users of 1-BP. A list of external meetings held during the development of this proposed rule is in the docket (Ref. 26); meeting materials and summaries are also in the docket. The purpose of these discussions was to create awareness and educate stakeholders and regulated entities on the provisions for risk management required under TSCA section 6(a); explain the risk evaluation findings; obtain input from manufacturers, processors, distributors, users, academics, advisory councils, and members of the public health community about uses of 1-BP; identify workplace practices, engineering controls, administrative controls, PPE, and industrial hygiene plans currently in use or feasibly adoptable to reduce exposure to 1-BP under the conditions of use; understand the importance of 1-BP in the various uses subject to this proposed rule; compile knowledge about critical uses, substitute chemicals or alternative methods; identify various standards and performance specifications; and generate potential risk reduction strategies. EPA has met with, or otherwise communicated with, a variety of companies, trade associations and non-governmental organizations to discuss the topics outlined in this paragraph; a list of external meetings held during the development of this proposed rule is in the docket. (Ref. 26).
EPA's
The 2020 Risk Evaluation for 1-BP considered impacts on both children and adults from occupational and consumer use from inhalation and dermal exposures, as applicable. For occupational use, the risk evaluation considered males (>16 years of age) and females of reproductive age (>16 years of age to less than 54 years of age) for both dermal and inhalation exposures. For consumer use, EPA evaluated dermal and inhalation exposures for children ages 11-15 and 16-20 years of age, and the evaluation of inhalation exposures to bystanders includes infants, toddlers, and older children. Several health effects of 1-BP exposure are relevant to early life stages, including developmental toxicity (
This unit describes the TSCA conditions of use that contribute to EPA's unreasonable risk determination for the chemical substance 1-BP. Condition of use descriptions were obtained from EPA sources such as CDR use codes, the 2020 Risk Evaluation for 1-BP and related documents, as well as the Organisation for Economic Co-operation and Development harmonized use codes and stakeholder engagements. For additional descriptions of the conditions of use, including process descriptions and worker activities considered in the risk evaluation, see the Problem Formulation of the 2020 Risk Evaluation for 1-BP, the 2020 Risk Evaluation for 1-BP, and supplemental files (Refs. 28, 1, 29). EPA acknowledges that some of the terms in this unit may be defined under other statutes, however the descriptions here are intended to provide clarity to the regulated entities who will implement the provisions of this rulemaking under TSCA section 6(a).
This condition of use refers to the making or producing of a chemical substance within the United States (including manufacturing for export), or the extraction of a component chemical substance from a previously existing chemical substance or a complex combination of substances.
This condition of use refers to the act of causing a chemical substance or mixture to arrive within the customs territory of the United States.
This condition of use refers to processing 1-BP in chemical reactions for the manufacturing of another chemical substance or product. Through processing as a reactant or intermediate, 1-BP serves as a feedstock in the production of another chemical product via a chemical reaction in which 1-BP is completely consumed. For example, 1-BP is used as a reactant in the production of other organic and inorganic chemicals, pesticides, fertilizers, and other agricultural chemicals.
This condition of use refers to when 1-BP is added to a product (or product mixture) prior to further distribution of the product.
This condition of use refers to when 1-BP becomes an integral component of an article distributed for industrial, commercial, or consumer use. An article refers to a manufactured item which: (1) Is formed to a specific shape or design during manufacture; (2) has end use function(s) dependent in whole or in part upon its shape or design during end use; and (3) has either no change of chemical composition during its end
This condition of use refers to the preparation of a chemical substance or mixture for distribution in commerce in a different form, state, or quantity. This includes transferring of 1-BP from a bulk container into smaller containers.
This condition of use refers to processing waste streams of 1-BP at a third-party site for the purpose of recovering materials or otherwise preparing the waste for reuse instead of disposal. Waste solvents can be restored via solvent reclamation/recycling. The recovery process may involve an initial vapor recovery or mechanical separation step followed by distillation, purification, and final packaging.
This condition of use refers to the industrial and commercial use of 1-BP as a solvent for cleaning and degreasing through the process of heating 1-BP to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using batch open-top and in-line conveyorized vapor degreaser machines.
This condition of use refers to the industrial and commercial use of 1-BP as a solvent for cleaning and degreasing through the process of heating 1-BP to its volatilization point and using its vapors to remove dirt, oils, greases, and other surface contaminants from metal and other parts using batch closed-loop degreaser machines.
This condition of use refers to the industrial and commercial use of 1-BP as a non-boiling solvent in cold cleaning machines, including simple spray sinks and dip tanks, to remove dirt, oils, greases, and other surface contaminants from metal and other parts.
This condition of use refers to the industrial and commercial use of 1-BP as a solvent in degreasing and cleaning products to remove dirt, grease, stains, spots, and foreign matter through a process that uses an aerosolized solvent spray, typically applied from a pressurized can, to remove residual contaminants from electronics, metals, and other fabricated materials. This description does not apply to use of 1-BP in products intended for automotive care, anti-adhesive agents for mold cleaning and release products, adhesive accelerants for arts, crafts, and hobby materials, or functional fluids, which are described in “Other industrial and commercial uses” in this unit, or dry cleaning solvents and stain removers, which are described in “Industrial and commercial use in dry cleaning solvents, spot cleaners and stain removers” in this unit.
This condition of use refers to the industrial and commercial use of 1-BP as a solvent in spray adhesives and sealants for foam cushion manufacturing and fabrication (
This condition of use refers to the industrial and commercial use of 1-BP in products for spot cleaning and as a solvent in degreasing and cleaning applications to remove dirt, grease, stains, spots, and foreign matter from garments at dry cleaning facilities. This includes dry cleaning facilities using third generation (dry-to-dry, non-vented machines with refrigerated condensers), fourth generation (dry-to-dry, non-vented machines with both refrigerated condensers and carbon adsorbers as secondary vapor controls), or fifth generation (dry-to-dry, non-vented machines with secondary vapor controls, a monitor inside the machine drum, and an interlocking system to ensure the concentration is below approximately 300 ppm before the loading door can be opened) 1-BP dry cleaning machines. In addition to use as a solvent in dry cleaning equipment, 1-BP is found in products to spot clean garments to remove stains or spots before and after dry cleaning treatment.
This condition of use refers to the industrial and commercial use of 1-BP in aerosol and non-aerosol product formulations, designed to clean collectible coins and scissors.
This condition of use refers to the commercial use of 1-BP in insulation material in the form of rigid board insulation, which can be used for interior and exterior applications including walls, ceilings, roofs, foundations, basements, and crawl spaces in commercial and residential buildings.
This condition of use refers to the industrial and commercial uses of 1-BP in a variety of other aerosol and non-aerosol uses not already described previously in this unit.
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This condition of use refers to the consumer use of 1-BP in aerosolized products to dissolve oils, greases, and similar materials from textiles, glassware, metal surfaces, and other articles. This includes the use of 1-BP in aerosolized products for cleaning or degreasing in electronic degreasers.
This condition of use refers to the consumer use of 1-BP for cleaning and furniture care in the form of spot cleaners or stain removers to remove dirt, grease, stains, and foreign matter from furniture or furnishings, or to cleanse, sanitize, or improve the appearance of surfaces.
This condition of use refers to the consumer use of 1-BP in liquid cleaning products to dissolve oils, greases, and stains, or to cleanse, sanitize, or improve the appearance of surfaces.
This condition of use refers to the consumer use of 1-BP in liquid and aerosolized products for cleaning and furniture care to remove dirt, grease, and stains, or to cleanse, scour, polish, protect, or improve the appearance of surfaces.
This condition of use refers to the consumer use of 1-BP in aerosolized products for arts, crafts, and hobby activities to accelerate the time it takes for the adhesive to dry.
This condition of use refers to the consumer use of 1-BP in liquid cleaning products to dissolve and flush out foreign materials from coils of an automobile AC coil.
This condition of use refers to the consumer use of 1-BP in products for mold cleaning and release. These products are used as anti-adhesive agents to prevent bonding between other substances by discouraging surface attachments.
This condition of use refers to the process of disposing generated waste streams of 1-BP that are collected and transported to a third-party site for their final disposition, such as waste incineration or landfilling.
For purposes of this proposed rulemaking, “occupational conditions of use” refers to the TSCA conditions of use described in Units III.B.1.a., b., c., and e. Although EPA identified both industrial and commercial uses in the 2020 Risk Evaluation for 1-BP for purposes of distinguishing scenarios, the Agency clarified then and clarifies now that EPA interprets the authority Congress gave to the Agency to “regulat[e] any manner or method of commercial use” under TSCA section 6(a)(5) to reach both industrial and commercial uses.
Additionally, in the 2020 Risk Evaluation for the chemical substance 1-BP, EPA identified and assessed all known, intended, and reasonably foreseen industrial, commercial, and consumer uses of 1-BP, and determined in the December 2022 final revised unreasonable risk determination that 1-BP as a whole chemical substance presents unreasonable risks to health and the environment. EPA determined that all industrial, commercial, and consumer uses of 1-BP evaluated in the 2020 Risk Evaluation for 1-BP contribute to the EPA determination that 1-BP presents unreasonable risk of injury to health, except for the use of 1-BP in insulation. As such, for purposes of this risk management rulemaking, “consumer use” refers to all known, intended, and reasonably foreseen consumer uses of 1-BP, except for the use of 1-BP in insulation. Likewise, for the purpose of this risk management rulemaking, “industrial and commercial use” refers to all industrial and commercial uses, including known, intended, or reasonably foreseen 1-BP industrial and commercial use, except for the use of 1-BP in insulation.
EPA is not proposing to incorporate the descriptions of known, intended or reasonably foreseen uses in Unit III.B.1.a. through e. into the regulatory text as definitions because these uses represent the specific uses evaluated in the 2020 Risk Evaluation for 1-BP. This risk evaluation was used to inform EPA's determination that 1-BP presents unreasonable risk. EPA requests comment on whether EPA should promulgate definitions for those conditions of use evaluated in the 2020 Risk Evaluation for 1-BP that would not be prohibited, and, if so, whether the descriptions in this unit are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for 1-BP and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation if EPA were to promulgate a regulation that contains a list of the industrial and commercial conditions of use evaluated in the 2020 Risk Evaluation for 1-BP.
EPA also requests comment on whether, rather than just excluding the consumer and commercial uses of 1-BP in insulation from the prohibitions and other requirements in this risk management rulemaking, EPA should more broadly exclude the use of articles under TSCA section 6(c)(2)(E), which would also exclude the use of 1-BP in articles that were not specifically evaluated in the 2020 Risk Evaluation for 1-BP, and if so, whether and how to define “article” for the purposes of this rulemaking.
EPA further notes that this proposed rule does not apply to any substance excluded from the definition of “chemical substance” under TSCA 3(2)(B)(ii) through (vi). Those exclusions include, but are not limited to, any pesticide (as defined by the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; and any food, food additive, drug, cosmetic, or device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA), when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device.
EPA has determined that 1-BP presents an unreasonable risk of injury to human health under the conditions of use based on acute and chronic non-cancer risks and chronic cancer risks (Ref. 2). As described in the TSCA
To make the unreasonable risk determination for 1-BP, EPA evaluated exposures to workers, ONUs, consumer users, and bystanders to consumer use, using reasonably available monitoring and modeling data for inhalation and dermal exposures (Ref. 2). The August 2020 Risk Evaluation for 1-BP did assess the water pathway based on environmental fate characteristics and monitoring and modeling data. Based on this analysis, EPA determined that 1-BP would be unlikely to be present in surface water (Ref. 1). EPA conducted a screening level analysis to determine whether there may be potential risks from the ambient air pathway to fenceline communities. A discussion of EPA's analysis and the expected effects of this rulemaking on fenceline communities and the ongoing revisions of National Emission Standards for Hazardous Air Pollutants (NESHAPs) under the CAA is in Unit VI.A.
For the 2020 Risk Evaluation for 1-BP, EPA considered PESS. EPA identified the following groups as PESS: workers, ONUs, consumers, bystanders, and those with certain pre-existing health conditions, higher body fat content, or particular genetic polymorphisms (Ref. 1). Furthermore, the developing fetus and (by extension) women of childbearing age were identified as susceptible life stages (Ref. 1). All PESS and susceptible life stages are included in the quantitative and qualitative analyses described in the risk evaluation and were considered in the determination of unreasonable risk for 1-BP. As discussed in Units II.D. and VI.A., the 2020 Risk Evaluation for 1-BP did not fully assess the ambient air exposure pathways to the general population in the published risk evaluation; this may have caused some risks to be unaccounted for in the risk evaluation and in EPA's risk determination. EPA considers people in communities in proximity to facilities using 1-BP who are exposed to 1-BP through the ambient air pathway to constitute a subset of the general population and categorizes them as fenceline communities; they may also be considered PESS. See Unit VI.A. for further discussion on assessing and protecting against risk to fenceline communities.
EPA examined the TSCA section 6(a) requirements (listed in Unit III.A.) to identify which ones have the potential to eliminate the unreasonable risk for 1-BP. This unit summarizes the TSCA section 6 considerations for issuing regulations under TSCA section 6(a). Unit V. outlines how EPA applied these considerations specifically to managing the unreasonable risk from 1-BP.
As required, EPA developed a proposed regulatory action and one or more primary alternative regulatory actions, which are described in Units IV.A. and IV.B., respectively. To identify and select a regulatory action, EPA considered the two routes of exposure driving the unreasonable risk, inhalation and dermal, and the exposed populations. For occupational conditions of use (see Unit III.B.1.f.), EPA considered how it could directly regulate manufacturing (including import), processing, distribution in commerce, industrial and commercial use, or disposal to address the unreasonable risk. EPA does not have direct authority to regulate consumer use. Therefore, EPA considered how it could exercise its authority under TSCA to regulate the manufacturing (including import), processing, and/or distribution in commerce of 1-BP at different points in the supply chain to eliminate exposures or restrict the availability of 1-BP and 1-BP-containing products for consumer use in order to address the unreasonable risk.
As required by TSCA Section 6(c)(2), EPA considered several factors, in addition to identified unreasonable risk, when selecting among possible TSCA section 6(a) requirements. To the extent practicable, EPA factored into its decisions: (1) the effects of 1-BP on health and the environment, (2) the magnitude of exposure to 1-BP of human beings and the environment, (3) the benefits of 1-BP for various uses, and (4) the reasonably ascertainable economic consequences of the rule. In evaluating the reasonably ascertainable economic consequences of the proposed rule, EPA considered (1) the likely effect of the proposed rule on the national economy, small business, technological innovation, the environment, and public health, (2) the costs and benefits of the proposed regulatory action and one or more primary alternative regulatory actions considered, and (3) the cost effectiveness of the proposed regulatory action and of the one or more primary alternative regulatory actions considered. See Unit VI. for further discussion related to TSCA section 6(c)(2)(A) considerations, including the statement of effects of the proposed rule with respect to these considerations.
EPA also considered the regulatory authority under TSCA and other statutes such as the OSH Act, the Consumer Product Safety Act (CPSA), and other EPA-administered statutes to examine (1) whether there are opportunities for all or part of risk management action on 1-BP to be addressed under other statutes, such that a referral may be warranted under TSCA sections 9(a) or 9(b); or (2) whether TSCA section 6(a) regulation could include alignment of requirements and definitions in and under existing statutes to minimize confusion to the regulated entities and the general public.
In addition, EPA followed other TSCA requirements such as considering the availability of alternatives when contemplating prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as outlined in Unit V.B.), and setting proposed compliance dates in accordance with the requirements in TSCA section 6(d)(1) (described in the proposed and alternative regulatory actions in Unit IV.).
To the extent information was reasonably available, when selecting regulatory actions, EPA considered pollution prevention and the hierarchy of controls adopted by OSHA and NIOSH, with the goal of identifying risk management control methods that are permanent, feasible, and effective. EPA also considered how to address the unreasonable risk while providing flexibility to the regulated entities where appropriate. EPA considered the information presented in the 2020 Risk Evaluation for 1-BP, as well as additional input from stakeholders (as described in Unit III.A.), and anticipated
Taken together, these considerations led EPA to the proposed regulatory action and primary alternative regulatory actions described in Unit IV. Additional details related to how the requirements in this unit were incorporated into development of those actions are in Unit V.
As demonstrated by the number of distinct programs addressed in this rulemaking and the structure of this proposed rule in addressing them independently, EPA generally intends the rule's provisions to be severable from each other. EPA expects to provide additional detail on severability in the final rule once the Agency has considered public comments and finalized the regulatory language.
This unit describes the proposed regulatory action by EPA so that 1-BP will no longer present an unreasonable risk of injury to health. In addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider the costs and benefits and the cost-effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions. In the case of 1-BP, the proposed regulatory action is described in Unit IV.A. and the two alternative regulatory actions considered are described in Unit IV.B. An overview of the proposed regulatory action and two alternative regulatory actions for each condition of use is in Unit IV.C. The rationale for the proposed and alternative regulatory actions and associated compliance timeframes are discussed in this unit and in more detail in Unit V.A.
EPA is proposing under TSCA section 6(a) to: (1) prohibit the manufacture (including import), processing, and distribution in commerce of 1-BP for all consumer uses, excluding the use of 1-BP in insulation, outlined in Unit IV.A.1.b.; (2) prohibit the industrial and commercial use of 1-BP for four occupational uses, and the manufacture (including import), processing, and distribution in commerce of 1-BP for those uses, outlined in Unit IV.A.1.a.; (3) require strict workplace controls, including a 1-BP WCPP, which would include requirements to meet an inhalation exposure concentration limit and use of gloves for seven occupational conditions of use, outlined in Unit IV.A.2.; (4) require self-certification, which would document the purchaser's commitment to comply with the 1-BP WCPP, for six occupational conditions of use, outlined in Unit IV.A.1.4.; (5) require the use of prescriptive controls for six occupational conditions of use, outlined in Unit IV.A.1.3.; and (6) establish recordkeeping and downstream notification requirements, outlined in Unit IV.A.5. Pursuant to TSCA section 12(a)(2), this proposed rule would apply to 1-BP even if being manufactured, processed, or distributed in commerce solely for export from the United States because EPA has determined that 1-BP presents an unreasonable risk to health within the United States or to the environment of the United States.
EPA notes that some uses identified for prohibitions, the WCPP, or self-certification were identified within larger conditions of use in the 2020 Risk Evaluation for 1-BP. The regulatory action proposed for each use is described in this unit, and the rationale is provided in Unit V.
EPA is proposing to prohibit the manufacturing, processing, distribution in commerce, and use of 1-BP for industrial and commercial uses of 1-BP except for those uses which would continue under the WCPP, self-certification, and/or prescriptive controls. The proposed prohibitions under TSCA would not apply to any use of 1-BP that is excluded from TSCA's definition of “chemical substance” under TSCA section 3(2)(B)(ii)(vi). This proposed prohibition would include a prohibition on the manufacturing (including import), processing, distribution in commerce, and use of 1-BP for the following industrial and commercial uses:
• In adhesives and sealants;
• In dry cleaning solvents, spot cleaners and stain removers;
• In coin and scissor cleaner (liquid, spray, or aerosol cleaners); and
• In other uses in arts, crafts, hobby materials (adhesive accelerant); automotive care products (engine degreaser, brake cleaner, refrigerant flush); anti-adhesive agents (mold cleaning and release product); functional fluids (closed/open-systems)—refrigerant/cutting oils.
As discussed in Units III.B.3. and V.A., based on consideration of alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the feasibility of exposure reduction to sufficiently address the unreasonable risk across the broad ranges of work environments and activities, and the irreversible health effects associated with 1-BP exposures, EPA has determined that prohibition is the best way to address the unreasonable risks from 1-BP contributed by the conditions of use identified in this unit. As noted in Unit III.B.1.f., this proposal does not apply to any substance excluded from the definition of “chemical substance” under TSCA section 3(2)(B)(ii) through (vi).
EPA is proposing to stagger the compliance dates for the proposed prohibitions described in this unit, such that the requirements would come into effect in 6 months for manufacturers, 9 months for processors, 12 months for distributing to retailers, 15 months for all distributors (including retailers), and 18 months for industrial and commercial users after the publication date of the final rule. When proposing these compliance dates as required under TSCA section 6(d), EPA considered the irreversible health effects and risks associated with 1-BP exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be prohibited, or that additional time would be needed for products to clear the channels of trade. For 1-BP, for the conditions of use EPA is proposing to prohibit, the Agency believes either 1-BP may no longer be used, or regulated entities would be able to meet the proposed regulatory compliance timeframes, due to availability of alternatives. EPA recognizes that for other proposed regulations under TSCA section 6, including methylene chloride (88 FR 28284, May 3, 2023 (FRL-8155-02-OCSPP), perchloroethylene (88 FR 39652, June 16, 2023) (FRL-8329-02-OCSPP), and carbon tetrachloride (88 FR 49180, July 28, 2023) (FRL-8206-01-OCSPP), public comments have provided information in support of longer compliance timeframes. Similarly, for 1-BP, EPA requests comment on whether additional time is needed, for example, for products to clear the channels of trade, or for implementing the use of substitutes; comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time
In the 2020 Risk Evaluation for 1-BP, EPA evaluated consumer uses of 1-BP:
• As a solvent in aerosol spray degreasers/cleaners;
• In spot cleaners and stain removers;
• In liquid coin cleaners (
• In liquid spray/aerosol cleaners;
• In arts, crafts, hobby materials (adhesive accelerant);
• In automotive care products (refrigerant flush);
• In anti-adhesive agents (mold cleaning and release products); and
• In building/construction materials in insulation.
The consumer uses evaluated in the 2020 Risk Evaluation for 1-BP constitute all known, intended, and reasonably foreseen consumer uses of 1-BP. EPA determined that all of these consumer uses, except for the use of 1-BP in insulation, contribute to unreasonable risk of injury to health. As such, for purposes of this risk management rulemaking, “consumer use” refers to all consumer uses including known, intended, and reasonably foreseen consumer uses for 1-BP. EPA is proposing to prohibit the manufacturing, processing, and distribution in commerce of 1-BP for consumer use, except for the consumer use of 1-BP in insulation.
As discussed in Units III.B.3. and V.A., based on consideration of the severity of the hazards of 1-BP in conjunction with the limited options available to adequately address the identified unreasonable risk to consumers and bystanders under TSCA section 6(a), EPA is proposing to address the unreasonable risk from consumer use by prohibiting the manufacturing (including import), processing, and distribution in commerce of 1-BP for consumer use, in order to remove 1-BP and products containing 1-BP from the market, thereby effectively eliminating instances of consumer use that contribute to the unreasonable risk of injury to health.
Additionally, EPA is proposing to prohibit retailers from distributing in commerce 1-BP, including any 1-BP-containing products except insulation products, in order to prevent products intended for industrial and commercial use from being purchased by consumers. A retailer is any person or business entity that distributes or makes available chemical substances or products containing chemical substances to consumers, including through e-commerce internet sales or distribution. If a person or business entity distributes or makes available any product to at least one consumer, then it is considered a retailer (as EPA proposes to define that term in 40 CFR 751.5). For a distributor not to be considered a retailer, the distributor must distribute or make available chemical substances solely to commercial or industrial end-users or businesses. Prohibiting manufacturers (including importers), processors, and distributors from distributing 1-BP, or any products except insulation containing 1-BP, to retailers would prevent retailers from making these products available to consumers, which would help address that part of the unreasonable risk associated with consumer use of 1-BP. EPA is requesting comment on commercial distribution channels or systems that would allow for distribution to commercial users while preventing retailers from making these products available to consumers, or feasible distribution channels for commercial users that have been developed in analogous situations, including information on whether there are market barriers to such systems.
EPA is proposing that the prohibitions of manufacturing, processing, and distribution in commerce of 1-BP for consumer use described in this unit would become effective in 6 months for manufacturers, 9 months for processers, 12 months for distributing to retailers, and 15 months for all other distributors (including retailers) after the publication date of the final rule in the
As described in Unit III.B.3., under TSCA section 6(a), EPA is required to issue a regulation applying one or more of the TSCA section 6(a) requirements to the extent necessary so that the unreasonable risk of injury to health or the environment from a chemical substance is no longer presented. The TSCA section 6(a) requirements provide EPA the authority to limit or restrict a number of activities, alone or in combination, including the manufacture, processing, distribution in commerce, commercial use, and disposal of the chemical substance. Given this authority, EPA may find it appropriate in certain circumstances to propose requirements under a WCPP for certain occupational (
EPA uses the term “potentially exposed person” in this unit and in the regulatory text to include workers, occupational non-users, employees, independent contractors, employers, and all other persons in the work area where 1-BP is present and who may be exposed to 1-BP under the conditions of use for which a WCPP would apply. One important reason to define a potentially exposed person for the purposes of a WCPP as any person who may be exposed in the workplace is to emphasize the broad scope of exposures which must be categorized when
Similarly, the 2020 risk evaluation for 1-BP did not distinguish between employers, contractors, or other legal entities or businesses that manufacture, process, distribute in commerce, use, or dispose of 1-BP. EPA uses the term “owner or operator” to describe the entity responsible for implementing the WCPP for workplaces where an applicable condition of use of 1-BP is occurring. The term includes any person who owns, leases, operates, controls, or supervises such a workplace.
An ECEL is a risk-based inhalation exposure threshold. The ECEL would be accompanied by monitoring, training, recordkeeping and other requirements to help ensure that the threshold is not exceeded. With an ECEL, regulated entities have some flexibility, within certain parameters outlined in this unit, for preventing exceedances of the identified exposure threshold. Therefore, EPA generally refers to the ECEL and ancillary requirements as a non-prescriptive approach. In the case of 1-BP, the exposure threshold identified by EPA for certain occupational conditions of use would mitigate unreasonable risks from inhalation exposure contributed by those conditions of use for potentially exposed persons.
This unit includes a summary of the proposed 1-BP WCPP, including a description of the ECEL; proposed implementation requirements and a TSCA ECEL action level; proposed monitoring requirements; a description of potential exposure controls, which consider the hierarchy of controls; information that may be used to inform PPE selection; and additional requirements proposed for recordkeeping, and worker training, participation, and notification. This unit also describes compliance timeframes for these proposed requirements.
To reduce exposures in the workplace and address the unreasonable risk of injury to health resulting from inhalation exposures to 1-BP identified under the occupational conditions of use in the TSCA 2020 Risk Evaluation for 1-BP, EPA is proposing an ECEL of 0.05 parts per million (ppm) (0.25 mg/m3) for inhalation exposures to 1-BP as an 8-hour TWA. This ECEL is based on the cancer inhalation unit risk (IUR) at a risk level of 1 × 10
EPA has determined, as a matter of risk management policy, that ensuring exposures remain at or below the ECEL would eliminate the contribution to the unreasonable risk of injury to health for 1-BP resulting from inhalation exposures in an occupational setting. EPA is proposing to establish requirements to meet an ECEL as part of the WCPP for:
• Manufacturing (domestic manufacturing);
• Processing as incorporation into a formulation, mixture, or reaction products;
• Industrial and commercial use as a solvent in open-top and in-line batch vapor degreasing;
• Industrial and commercial use as a solvent in closed-loop vapor degreasing;
• Industrial and commercial use as a solvent for cleaning and degreasing in cold cleaners;
• Industrial and commercial use as a solvent in aerosol spray degreaser/cleaner; and
• Industrial and commercial use in other uses in electronic and electronic products and metal products; laboratory chemicals; asphalt extraction; and coatings for temperature indicators.
Each owner or operator of a workplace where these conditions of use occur would be responsible for compliance with the ECEL and the associated requirements. EPA's description for how the requirements related to an ECEL would address the unreasonable risk resulting from inhalation exposures and the rationale for this regulatory approach are outlined in Units III.B.3. and V.A.
If ambient exposures are kept at or below the 8-hour ECEL of 0.05 ppm, EPA expects that a potentially exposed person in the workplace would be protected against non-cancer effects resulting from occupational exposures, as well as excess risk of cancer (Ref. 12).
EPA is also proposing to establish an ECEL action level of 0.03 ppm as an 8-hour TWA for 1-BP. Air concentrations at or above the action level would trigger more frequent periodic monitoring of exposures to 1-BP, as described in this unit. EPA is proposing to adopt the action level approach in implementing the TSCA ECEL, consistent with the action level approach utilized by OSHA in the implementation of OSHA standards. As explained by OSHA, due to the variable nature of employee exposures, compliance with an action level provides employers with greater assurance that their employees will not be exposed to concentrations above the PELs (Ref. 31). EPA agrees with this reasoning and, like OSHA, expects the inclusion of an ECEL action level will stimulate innovation within industry to reduce exposures to levels below the action level. Therefore, EPA has identified a need for an action level for 1-BP and is proposing a level that is lower than the 8-hour ECEL, which is in alignment with the precedented approach established under most OSHA standards. EPA is soliciting comment regarding an ECEL action level that is lower than the ECEL.
In summary, EPA is proposing that each owner or operator of a workplace subject to the ECEL must ensure that no person is exposed to airborne concentration of 1-BP in excess of 0.05 ppm as an 8-hr TWA, with an action level identified as 0.03 ppm as an 8-hr TWA. For conditions of use for which requirements to meet an ECEL are being proposed, EPA believes that the regulated community has the ability to detect the values for the ECEL and ECEL action level as they are above the threshold of 1-BP monitoring devices, which can detect concentration levels as low as ≤0.0005 ppm (Ref. 12). The Agency has also identified personal breathing zone air sampling devices with a minimum limit of quantitation and level of detection at the ECEL level. (Ref. 12) EPA is requesting comment on
EPA expects that many workplaces already have stringent controls in place that reduce exposures to 1-BP; for some workplaces, including those engaged in vapor degreasing, cold cleaning, and use of 1-BP in electronics and electronic products, EPA understands that these existing controls may already reduce 1-BP air concentration levels to near or below the ECEL (Ref. 32). As discussed further in Unit V.A.1., for some conditions of use for which EPA is proposing the ECEL, data were submitted during the risk evaluation that indicate inhalation exposures may already be near or below the ECEL for some facilities, indicating that such facilities may already be in compliance with the proposed ECEL. As noted previously in this unit, EPA expects that, if inhalation exposures for affected occupational conditions of use are kept at or below the ECEL, potentially exposed persons reasonably likely to be exposed in the workplace would be protected from the unreasonable risk.
EPA is also proposing to require owners or operators to comply with additional requirements under the WCPP that would be needed to ensure successful implementation of the ECEL.
EPA is proposing to require each owner or operator to establish an initial baseline monitoring sample to determine the magnitude of exposure for all persons who may be exposed to 1-BP within 33 months for Federal agencies and Federal contractors acting for or on behalf of the Federal Government and within 6 months after the date of publication of the final rule in the
EPA also recognizes that some entities may already have exposure monitoring data. If the owner or operator has monitoring data conducted within five years prior to the effective date of the final rule and the monitoring satisfies all other requirements of this section, including the requirement that the data represent the highest 1-BP exposures likely to occur under reasonably foreseeable conditions of use, the owner or operator may rely on such earlier monitoring results for the initial baseline monitoring sample.
• If samples taken during the initial exposure monitoring reveal a concentration below the ECEL action level (<0.03 ppm 8-hr TWA), the owner or operator must repeat the periodic exposure monitoring at least once every 5 years.
• If the most recent exposure monitoring indicates that airborne exposure is above the ECEL (>0.05 ppm 8-hour TWA), the owner or operator must repeat the periodic exposure monitoring within 3 months of the most recent exposure monitoring.
• If the most recent exposure monitoring indicates that airborne exposure is at or above the ECEL action level (≥ 0.03 ppm 8-hour TWA) but at or below the ECEL (≤ 0.05 ppb 8-hour TWA), the owner or operator must repeat the periodic exposure monitoring within 6 months of the most recent exposure monitoring.
• If the most recent (non-initial) exposure monitoring indicates that airborne exposure is below the ECEL action level, the owner or operator must repeat such monitoring within 6 months of the most recent monitoring until two consecutive monitoring measurements, taken at least seven days apart, are below the ECEL action level (<0.03 ppb 8-hour TWA), at which time the owner
Additionally, in instances where an owner or operator does not manufacture, process, use, or dispose of 1-BP for a condition of use for which the WCPP is proposed over the entirety of time since the last required periodic monitoring event, EPA is proposing that the owner or operator would be permitted to forgo the next periodic monitoring event. However, documentation of cessation of use of 1-BP would be required and periodic monitoring would be required to resume should the owner or operator restart any of the conditions of use listed in Unit IV.A.2. for which the WCPP is proposed. The timeframe for periodic monitoring after an owner or operator restarts a condition of use would be based on the most recent monitoring measurements and the timeframe would begin from the date of restart.
The proposed periodic monitoring requirements are also outlined in Table 1. EPA requests comment on the proposed timeframes for periodic monitoring outlined in this unit. EPA may finalize significantly shorter or longer compliance timeframes based on public comment.
EPA is requesting comment on the proposed timeframe of within 30 days to conduct additional exposure monitoring after there has been a change in the production, process, control equipment, personnel or work practices may reasonably be expected to result in new or additional exposures at or above the ECEL action level, or when the owner or operator has any reason to believe that new or additional exposures at or above the ECEL action level have occurred. EPA is also requesting comment on the proposed timeframe of within 30 days to conduct additional exposure monitoring after the cleanup of the spill or repair of the leak, rupture or other breakdown.
EPA is also proposing to require that each owner or operator maintain exposure monitoring records that include the following information for each monitoring event:
(A) Dates, duration, and results of each sample taken.
(B) All measurements that may be necessary to determine the conditions (
(C) Name, workplace address, work shift, job classification, and work area of the person monitored; documentation of all potentially exposed persons whose exposures the monitoring is intended to represent if using a representative sample; and type of respiratory protective device worn by the monitored person, if any.
(D) Use of appropriate sampling and analytical methods, such as analytical methods already approved by EPA, OSHA or NIOSH, or compliance with an analytical method verification procedure.
(E) Compliance with the Good Laboratory Practice Standards at 40 CFR part 792.
(F) Information regarding air monitoring equipment, including: type, maintenance, calibrations, performance tests, limits of detection, and any malfunctions.
EPA is proposing to require owners or operators to implement the WCPP in accordance with the hierarchy of controls and encourages the use of pollution prevention to control exposures whenever practicable. Pollution prevention, also known as source reduction, is any practice that reduces, eliminates, or prevents pollution at its source (
If an effort to identify and implement feasible exposure controls such as elimination, substitution, engineering controls, and administrative controls is not sufficient to reduce exposures to or below the ECEL for all persons in the workplace, EPA proposes to require each owner or operator to use such controls to reduce 1-BP concentrations in the workplace to the lowest levels achievable and, only after levels cannot be further reduced, supplement these controls using respiratory protection before persons are permitted to enter a regulated area, as described in this unit. In such cases, EPA would require that the owner or operator provide those persons exposed or who may be exposed to 1-BP by inhalation above the ECEL with respirators sufficient to ensure that their exposures do not exceed the ECEL, as described in this unit. EPA also proposes to require that each owner or operator document their evaluation of elimination, substitution, engineering and administrative exposure control strategies, and if applicable the reasons why they found these strategies infeasible to control exposures to or below the ECEL, in an exposure control plan as described in this unit. In addition, a regulated entity would be prohibited from rotating work schedules of potentially exposed persons to comply with the ECEL 8-hour TWA. EPA may require more, less, or different documentation regarding exposure control strategies in the final rule based on consideration of public comments.
The Agency understands that certain engineering controls can reduce exposures to people inside the workplace but may lead to increased ventilation of 1-BP outside of the workplace, thereby increasing risks to people in fenceline communities of adverse health effects from exposures to 1-BP in ambient air. Therefore, EPA is proposing to prohibit increased releases of 1-BP to outdoor air associated with the implementation of the WCPP. This proposed requirement is intended to avoid unintended increases in exposures to people from 1-BP emissions to ambient air. The proposed rule would require owners and operators to attest in their WCPP exposure control plan that engineering controls selected do not increase emissions of 1-BP to ambient air outside of the workplace and document in their exposure control plan whether additional equipment was installed to capture emissions of 1-BP to ambient air. EPA requests comment on how this proposed requirement may impact the availability, feasibility, or cost of engineering controls as a means to reduce workplace exposures to or below the proposed ECEL.
Based on the exposure monitoring, EPA is proposing to require that owners or operators of workplaces subject to a WCPP demarcate any area where airborne concentrations of 1-BP exceed or are reasonably expected to exceed the ECEL. Regulated areas would be demarcated using administrative controls, such as warning signs or highly visible signifiers, in multiple languages as appropriate (
EPA proposes that the owner or operator must, within 15 working days after receipt of the results of any exposure monitoring, notify each person whose exposure is represented by that monitoring in writing, either individually to each potentially exposed person or by posting the information in an appropriate location accessible to all persons whose exposure is represented by the monitoring, such as public spaces or common areas, outside the regulated area. This notice must include the exposure monitoring results, identification and explanation of the ECEL and ECEL action level in plain language, any corresponding required respiratory protection, if applicable, the quantity, location, manner of 1-BP use and identified releases of 1-BP that could result in exposure to 1-BP at the time of monitoring. The notice must also include a description of actions
Where elimination, substitution, engineering controls, and administrative controls are not feasible to reduce the air concentration to or below the ECEL for all potentially exposed persons, EPA is proposing to require implementation of a respiratory PPE program in alignment with OSHA's Respiratory Protection Standard at 29 CFR 1910.134. EPA is also proposing to require implementation of a dermal PPE program. Owners and operators would be required to provide PPE, including respiratory protection and dermal protection selected in accordance with the guidelines described in this unit, that is of safe design and construction for the work to be performed. EPA is proposing to require owners and operators to ensure each potentially exposed person who is required by this unit to wear PPE to use and maintain PPE in a sanitary, reliable, and undamaged condition. Owners and operators would be required to select and provide PPE that properly fits each potentially exposed person who is required by this unit to use PPE and communicate PPE selections to each affected person.
As part of the PPE program, EPA is also proposing that owners and operators must comply with OSHA's PPE training requirements at 29 CFR 1910.132(f) or 29 CFR 1910.134(k) for application of a PPE training program, including providing training on proper use of PPE (
This unit includes a description of the PPE Program, including proposed PPE as it relates to respiratory protection, proposed PPE as it relates to dermal protection, and other proposed requirements such as additional training for respirators and recordkeeping to support implementation of a PPE program.
Where elimination, substitution, engineering controls, and administrative controls are not feasible to reduce the air concentration to or below the ECEL, EPA proposes to set minimum respiratory PPE requirements based on an entity's most recent measured air concentration and the level of PPE that EPA determined would be needed to reduce exposure to the ECEL. In those circumstances, EPA is proposing to require a respiratory protection PPE program with worksite-specific procedures and elements for required respirator use. The respiratory protection PPE program proposed by EPA would be based on the most recent exposure monitoring concentration measured as an 8-hour TWA and would be administered by a suitably trained program administrator. EPA is also proposing to require each owner or operator select respiratory protection in accordance with the guidelines described in this unit and 29 CFR 1910.134(a) through (l), except (d)(1)(iii) for proper respirator use, maintenance, fit-testing, medical evaluation, and training. EPA is not proposing to cross reference 29 CFR 1910.134(d)(1)(iii) because the proposed WCPP contains requirements for identifying 1-BP respiratory hazards in the workplace, including monitoring requirements.
EPA is proposing to establish minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the following proposed requirements may be used. While this unit includes respirator selection requirements for respirators of assigned protection factors (APF) of 1,000 or greater, EPA does not anticipate that respirators beyond APF 50 would be widely or regularly used to address unreasonable risk, particularly when other controls are put in place. EPA is proposing the following requirements for respiratory protection, based on the exposure monitoring concentrations measured as an 8-hour TWA that exceed the ECEL (0.05 ppm):
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EPA proposes to require that owners and operators document respiratory protection used and PPE program implementation. EPA proposes to require that owners and operators document in the exposure control plan or other documentation of the facility's safety and health program information relevant to the respiratory program, including records on the name, workplace address, work shift, job classification, work area, and type of respirator worn (if any) by each potentially exposed person, maintenance, and fit-testing, as described in 29 CFR 1910.134(f), and training in accordance with 29 CFR 1910.132(f) and 29 CFR 1910.134(k).
EPA is proposing to require owners or operators to provide and ensure potential exposed persons use chemically resistant gloves made of supported polyvinyl alcohol or a multiple-layer laminated material, in accordance with the OSHA/NIOSH Hazard Alert (Ref. 14), in combination with specific activity training (
EPA proposes to require that owners and operators document their exposure control strategy and implementation in an exposure control plan. This may be accomplished by adding EPA-required information to any existing documentation of a facility's safety and health program developed as part of meeting OSHA requirements or other safety and health standards. EPA proposes to require that each owner or operator document in the exposure control plan the following:
(A) Identification and rationale of hierarchy of controls used or not used in the following sequence: elimination of 1-BP, substitution of 1-BP, engineering controls, and administrative controls to reduce 1-BP exposures in the workplace to either at or below the ECEL or to the lowest level achievable;
(B) The exposure controls selected based on feasibility, effectiveness, and other relevant considerations;
(C) If exposure controls were not selected, document the efforts identifying why these are not feasible, not effective, or otherwise not implemented;
(D) Actions that must be taken to implement exposure controls selected, including proper installation, regular inspections, maintenance, training or other actions;
(E) Description of any regulated area and how it is demarcated, and identification of authorized persons;
(F) Attestation that exposure controls selected do not increase emissions of 1-BP to ambient air outside of the workplace and whether additional equipment was installed to capture or otherwise prevent increased emissions of 1-BP to ambient air;
(G) Description of activities conducted by the owner or operator to review and update the exposure control plan as necessary, but at least every 5 years, to ensure effectiveness of the exposure controls, identify any necessary updates to the exposure controls, and confirm that all persons are properly implementing the exposure controls;
EPA is proposing that non-Federal owners or operators implement an exposure control plan within 12 months after date of publication of the final rule in the
EPA is also proposing to require implementation of a training program in alignment with the OSHA Hazard Communication Standard (29 CFR 1910.1200) and the OSHA General Industry Standard for Methylene Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons in the workplace are informed of the hazards associated with 1-BP exposure, EPA is proposing to require that owners or operators of workplaces subject to the WCPP institute a training and information program for potentially exposed persons and assure their participation in the training and information program.
As part of the training and information program, the owner or operator would be required to provide information and comprehensive training in an understandable manner (
In addition to providing training at the time of initial assignment to a job involving potential exposure to 1-BP, and in alignment with the OSHA General Industry Standard for Beryllium (20 CFR 1910.1024), owners and operators subject to the 1-BP WCPP would be required to re-train each potentially exposed person annually to ensure they understand the principles of safe use and handling of 1-BP in the workplace. Owners and operators would also need to update the training as necessary whenever there are changes in the workplace, such as new tasks or modifications of tasks, in particular, whenever there are changes in the workplace that increase exposure to 1-BP or where potentially exposed persons' exposure to 1-BP can reasonably be expected to exceed the action level. To support compliance, EPA is proposing that each owner or operator of a workplace subject to the WCPP would be required to provide to the EPA, upon request, all available materials related to workplace information and training.
EPA encourages owners and operators to consult with persons that have potential for exposure on the development and implementation of exposure control plans and PPE (including respirators) programs. EPA is proposing to require owners or operators to provide potentially exposed persons regular access to the exposure control plans, exposure monitoring records, and PPE program implementation and documentation. To ensure compliance in workplace participation, EPA is proposing that the owner or operator document the notice to and ability of any potentially exposed person to readily access the exposure control plans, facility exposure monitoring records, PPE program implementation, or any other information relevant to 1-BP exposure in the workplace. EPA is also proposing that potentially exposed persons be permitted to observe exposure monitoring. EPA is requesting comment on how owners and operators can engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program. EPA is also requesting comment on whether EPA should include provisions allowing potentially exposed persons to designate a representative who would then be permitted to observe exposure monitoring and have regular access to exposure-related information at the request of the potentially exposed person.
To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to a WCPP retain compliance records for five years. EPA is proposing to require records to include: (A) The exposure control plan; (B) PPE program implementation and documentation, including as necessary, respiratory protection and dermal protection used and related PPE training; and (C) information and training provided to each person prior to or at the time of initial assignment and any re-training.
In addition, EPA is proposing that owners and operators subject to the WCPP ECEL requirements maintain records to include: (D) the exposure monitoring records; (E) notification of exposure monitoring results; (F) to the extent that the owner or operator relies on prior exposure monitoring data, records that demonstrates that it meets all of the requirements of this section; and (G) the occurrence and duration of any start-up, shutdown, or malfunction of the facility that causes air concentrations to be above the ECEL, and subsequent corrective actions taken during start-up, shutdown, or malfunctions to mitigate exposures to 1-BP.
The owners and operators, upon request by EPA, would be required to make all records that are maintained as described in this unit available to EPA. All records required to be maintained by this unit could be kept in the most administratively convenient form (electronic or paper).
EPA is proposing to require each non-Federal owner and operator of a workplace, other than Federal agencies and Federal contractors acting for or on behalf of the Federal Government, subject to an ECEL conduct initial baseline monitoring according to the process outlined in this unit by 6 months after date of publication of the final rule in the
With regard to the compliance timeframe for those occupational conditions of use which are subject to dermal requirements under the WCPP, EPA is proposing to require each non-Federal owner or operator of a workplace subject to dermal requirements to provide dermal protection as outlined in this unit by 9 months after publication of the final rule in the
However, EPA is concerned about the ability of certain departments and agencies of the Federal Government, as well as Federal contractors acting for or on behalf of the Federal Government, to comply with these timeframes. For example, complying with these timeframes could impact the ability of the Department of Defense to continue to engage in vapor degreasing. While, for example, 29 CFR 1960 sets forth procedures and guidelines for ensuring that Federal workers are protected in comparable ways to their non-Federal counterparts, EPA believes that compliance with this proposed rulemaking would require increased and different preparations on the part of Federal agencies. For example, Federal agencies must follow procurement requirements which will likely result in increased compliance timelines. In addition, these requirements would require support in the Federal budget, which, for some agencies, is a multi-year process. Therefore, EPA is generally providing three years for agencies of the Federal Government and their contractors, when acting for or on behalf of the Federal government, to comply with the WCPP. Further, because military construction must follow a lengthy Congressional approval process prior to contracting for and beginning any actual construction work, which takes a minimum of 5 years, EPA is also proposing 5 years after the date of the publication of the final rule for the Department of Defense and Federal contractors acting for or on behalf of the Department of Defense if ongoing or planned construction is necessary to implement the feasible controls required by the WCPP to reduce exposure to or below the ECEL.
When proposing these compliance dates as required under TSCA section 6(d), EPA considered irreversible health effects and risks associated with 1-BP exposure. EPA has no reasonably available information indicating that the proposed compliance dates are not practicable for the activities that would be impacted, or that additional time is needed to implement all aspects of the WCPP. However, EPA requests comment on whether additional time is needed or if there are available substitutes for these applications. As discussed in Unit IV.A.1., EPA recognizes that recent proposed rulemakings under TSCA section 6(a) have received public comments requesting longer compliance timeframes. For 1-BP, EPA believes that the proposed compliance timeframes for the WCPP described in this unit may present fewer compliance challenges for non-Federal owners and operators. than those described by commenters on other rules; for example, under the WCPP, owners or operators would have some flexibility, within the parameters outlined in this unit, regarding how they prevent exceedances of the ECEL. EPA may finalize shorter or longer compliance timeframes based on consideration of public comments.
In contrast to the proposed non-prescriptive requirements of the ECEL where regulated entities would have flexibility to select controls in accordance with the hierarchy of controls to comply with the parameters outlined in this unit, EPA may also find it appropriate in certain circumstances to require specific prescriptive controls for certain occupational conditions of use. In the 2020 Risk Evaluation for 1-BP, EPA identified that the use of gloves would reduce dermal exposures from 1-BP adequate to address the unreasonable risk driven by dermal exposures. Therefore, EPA is proposing to require the use of use of chemically-resistant gloves made of supported polyvinyl alcohol or multiple-layer laminated materials for certain occupational conditions of use, as described in this unit. This unit describes proposed requirements for the gloves, including additional requirements proposed for recordkeeping. This unit also describes compliance timeframes for these proposed requirements.
For the conditions of use that would not otherwise be prohibited under this proposed regulation or subject to the WCPP, EPA is proposing the owner or operator apply prescriptive controls to reduce dermal exposures in the workplace and address the unreasonable risk of injury to health resulting from dermal exposures to 1-BP. Specifically, EPA is proposing that the owner or operator supply and ensure the use of chemically-resistant gloves made of supported polyvinyl alcohol or multiple-layer laminated materials, by all persons likely to be dermally exposed to 1-BP (including industrial and commercial products containing 1-BP). EPA is proposing to establish glove requirements for:
• Manufacturing (import);
• Processing as a reactant;
• Processing as incorporation into articles;
• Processing by repackaging;
• Recycling; and
• Disposal.
EPA is proposing to require owners or operators of a facility engaged in one or more uses of 1-BP as listed in this unit, to supply and ensure proper use of gloves, as described in this unit and in accordance with the 2020 Risk Evaluation for 1-BP and the OSHA/NIOSH Hazard Alert (Ref. 14). In the 2020 Risk Evaluation for 1-BP, EPA identified the use of gloves with a protection factor (PF) of 5 as adequate to address the unreasonable risk presented by dermal exposures to 1-BP. As described in the 2020 Risk Evaluation for 1-BP, a glove with a protection factor of 5 is a glove “with available permeation data indicating that the material of construction offers good protection for the substance.”
To further ensure correct glove usage, owners or operators must provide
To further ensure compliance, EPA proposes to require that owners and operators document the following information, as applicable: (A) The name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle 1-BP or handle equipment or materials on which 1-BP may present; (B) the type of glove being used at the facility, either supported polyvinyl alcohol or multiple-layer laminates; and (C) appropriately sized gloves and training on proper application, wear, and removal of gloves, and proper care/disposal of gloves.
EPA is soliciting comments on the requirements proposed in this unit for glove requirements. In addition, EPA understands that some workplaces rinse and reuse gloves after minimal use and is therefore soliciting comments on the impact on effectiveness of rinsing and reusing gloves. EPA also requests comment on the degree to which additional guidance related to use of gloves might be appropriate. EPA notes that disposal of gloves would be addressed by hazardous wastes requirements under 40 CFR 261.33.
EPA is proposing to require each non-Federal owner or operator supply chemically-resistant gloves made of supported polyvinyl alcohol or multiple-layer laminate, in accordance with this unit, to each potentially exposed person within 6 months after publication of the final rule.
As described in Unit IV.A.2.d.v, EPA is concerned about the ability of certain departments and agencies of the Federal Government, as well as Federal contractors acting for or on behalf of the Federal Government, to comply with the proposed timeframes for non-Federal owners and operators. For example, procurement requirements and the need for Federal budget support to implement these requirements will likely result in increased compliance timelines. Therefore, EPA is proposing 36 months for agencies of the Federal Government and their contractors, when acting for or on behalf of the Federal government, to provide and ensure the use of gloves that are chemically-resistant to 1-bromopropane, made of supported polyvinyl alcohol or a multiple-layer laminated materials, by all persons likely to be dermally exposed to 1-bromopropane (including products containing 1-bromopropane).
To ensure the safe and appropriate use of 1-BP, EPA is proposing to require most owners or operators who implement the WCPP to also self-certify as to their implementation of and compliance with the WCPP as a condition of the ability to purchase and use 1-BP in accordance with this regulation. EPA is proposing to establish requirements to self-certify for:
• Processing as incorporation into a formulation, mixture, or reaction product;
• Industrial and commercial use as a solvent in open-top and in-line batch vapor degreasing;
• Industrial and commercial use as a solvent in closed-loop vapor degreasing;
• Industrial and commercial use as a solvent for cleaning and degreasing in cold cleaners;
• Industrial and commercial use as a solvent in aerosol spray degreaser/cleaner; and
• Industrial and commercial use in other uses in electronic and electronic products and metal products; laboratory chemicals; asphalt extraction; and coatings for temperature indicators.
EPA is proposing a point-of-sale self-certification requirement in order to purchase and subsequently use 1-BP for those facilities that have the ability to implement and comply with a WCPP. As discussed further in Unit V.A.1.d., this self-certification would further ensure that only facilities able to implement and comply with a WCPP are able to purchase and use 1-BP. Under a self-certification requirement, entities would submit a self-certification to the distributor each time 1-BP is purchased. The self-certification would consist of a statement indicating that the facility is implementing a WCPP that would include an ECEL, PPE requirements, and ancillary requirements, the self-certification would be signed and presented by the facility owner or operator or person authorized to do so.
I certify each of the following statements under penalty of law. This document was prepared under my direction and supervision. This facility's implementation of the WCPP for 1-bromopropane was evaluated by qualified personnel with industrial hygiene qualifications or similar experience and that this facility has implemented and complies with the WCPP for 1-bromopropane. Based on my inquiry of the individual or individuals who manage the facility and/or those individuals directly responsible for implementing the 1-bromopropane WCPP, and to the best of my knowledge and belief, the facility is in compliance with the 1-bromopropane WCPP, including the exposure control plan. I am aware that there are significant penalties, including the possibility of civil penalties for failing to comply with these requirements and criminal fines and imprisonment, for knowingly failing to comply with these requirements. If this is the first purchase of 1-bromopropane for this facility, I understand that this certification will serve as a certification that this facility will properly implement and comply with the WCPP for 1-bromopropane consistent with the applicable regulatory timelines.
The self-certification statement must be signed and dated by the owner or operator of the facility, including a name, title, email address, and phone number for the owner or operator who is self-certifying. The self-certification statement must also list the name and address of the facility that is being certified; the condition of use, (
To ensure distributors are only selling 1-BP to owners or operators of facilities able to implement and comply with the workplace requirements of the WCPP, EPA is proposing to require owners or operators who self-certify to provide a copy of the facility's current self-certification statement to the distributor from whom 1-BP is being purchased, for every purchase of 1-BP. EPA is also proposing for the distributors to collect, maintain, and retain a copy of the self-certification statement. EPA is also proposing to require distributors to keep records, such as invoices, that indicate the name of the purchaser and facility, date of sale, and quantity of 1-BP purchased. Distributors of 1-BP for the uses described in this unit may only
In addition to the recordkeeping requirements for the WCPP, self-certification, and prescriptive controls outlined in this unit, for conditions of use that are not otherwise prohibited under this proposed regulation, EPA is also proposing that manufacturers, processors, distributors, and industrial and commercial users (except for the commercial use of 1-BP in insulation and insulation products) maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation; and to maintain such records for a period of 5 years from the date the record is generated. EPA is proposing that this requirement begin on the effective date of the final rule (60 days following publication of the final rule in the
For conditions of use that are not otherwise prohibited under this proposed regulation, EPA is proposing that manufacturers (including importers), processors, and distributors, excluding retailers, of 1-BP and 1-BP-containing products, except for the manufacture, processing, distribution in commerce, use, or disposal of 1-BP in building/construction materials (insulation), provide downstream notification of the prohibitions through the Safety Data Sheets (SDSs) required by OSHA under 29 CFR 191.1200(g) by adding to sections 1(c) and 15 of the SDS the following language:
After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
The intention of downstream notification is to spread awareness throughout the supply chain of the restrictions on the use of 1-BP under TSCA as well as provide information to commercial end users about allowable uses of 1-BP.
To provide adequate time to update the SDS and ensure that all affected products in the supply chain include the revised SDS, EPA is proposing a2-month period for manufacturers and a6-month period for processors and distributors to implement the proposed SDS changes following publication of the final rule.
EPA requests comments on the appropriateness of identified compliance timeframes for recordkeeping and downstream notification requirements described in this unit.
EPA acknowledges that after the issuance of this rule, once finalized, Federal agencies, their contractors, and other related entities may become aware of important information which indicates a particular use, that would otherwise be prohibited, could meet the criteria of section 6(g) or the requirements of a WCPP. EPA also notes that there are multiple avenues to ask EPA to revisit issues in this TSCA section 6(a) rulemaking, both before and after the mandatory compliance dates that are set consistent with TSCA section 6(d). EPA has the authority under TSCA section 6(g) to consider whether a time limited exemption is appropriate and, consistent with TSCA section 6(g)(1), could expeditiously promulgate such exemptions independently from this rulemaking, including consideration of emergency or interim rulemaking. EPA will initiate a notice of proposed rulemaking for public comment on this topic and will add this to the Spring 2024 Regulatory Agenda. Additionally, any person could petition EPA to request that EPA issue or amend a rule under TSCA section 6.
As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA must consider and publish a statement based on reasonably available information with respect to the reasonably ascertainable economic consequences of the rulemaking, including consideration of the costs and benefits and the cost effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions considered by the Agency. This unit includes a description of the primary alternative regulatory action and the second alternative regulatory action considered by the Agency. An overview of the proposed regulatory action and two alternative regulatory actions for each condition of use is in Unit IV.C.
The primary alternative regulatory action described in this document and considered by EPA combines prohibitions, requirements for a WCPP, self-certification, and prescriptive controls to address the unreasonable risk from 1-BP contributed by the various conditions of use. The primary alternative regulatory action described in this document differs from the proposed regulatory action by considering prescriptive workplace controls and implementation of a PPE program for some conditions of use that would be subject to a WCPP under the proposed regulatory action. The primary alternative regulatory action additionally considers alternative compliance timeframes for prohibitions and implementation of a WCPP and prescriptive controls, as described in this unit. EPA is putting forth only alternative regulatory options that would eliminate the unreasonable risk from 1-BP and notes that TSCA section 6(a) requires that EPA impose regulatory requirements to the extent necessary to address unreasonable risk. Thus, EPA has concluded that it would be most advantageous to put forth and receive public input on alternative regulatory options that the Agency could adopt in a final rule consistent with the requirements of TSCA section 6(a). Where EPA has identified different types of regulatory requirements that would address the unreasonable risk (
The primary alternative regulatory action considered by EPA would prohibit the manufacturing, processing, distribution in commerce, and use for the following industrial and commercial uses, which EPA is also proposing to prohibit as part of the proposed regulatory action: industrial and commercial use in adhesives and sealants; industrial and commercial use in dry cleaning solvents, spot cleaners and stain removers; industrial and commercial use in liquid cleaners (
Regarding compliance timeframes, the primary alternative regulatory action would include longer timeframes for implementation of the prohibitions than the proposed regulatory action. Under the primary alternative action, the prohibitions would generally take effect 6 months later than in the proposed regulatory action. Under a compliance timeframe that is 6 months longer than the proposed regulatory action, the prohibitions for the manufacturing, processing, distribution in commerce, and use of 1-BP for certain occupational conditions of use described in this unit would take effect 12 months for manufacturers, 15 months for processers, 18 months for distributing to retailers, 21 months for all other distributors (including retailers), and 24 months for industrial and commercial users after the publication date of the final rule. With regard to the compliance timeframe for the manufacturing, processing, and distribution in commerce for consumer use (except consumer use in building/construction materials in insulation), under the primary alternative regulatory action, prohibitions described in this unit would take effect in 12 months for manufacturers, 15 months for processors, 18 months for distributing to retailers, and 21 months for all other distributors (including retailers) after the publication date of the final rule.
The primary alternative regulatory action described in this document would require a WCPP, including requirements to meet an ECEL, for the following occupational conditions of use: manufacturing (domestic); processing into formulation, mixture, or reaction products; industrial and commercial use as solvent for cleaning and degreasing in cold cleaners; industrial and commercial use as solvent in aerosol spray degreaser/cleaner; and industrial and commercial use in other uses in electronic and electronic products and metal products; laboratory chemicals for asphalt extraction; coatings for temperature indicator. EPA requests comment on the ways in which 1-BP may be used in these conditions of use, including whether activities may take place in a closed system and the degree to which users of 1-BP in these sectors could successfully implement an ECEL and ancillary requirements described in Unit IV.A.
As with the compliance timeframes considered as part of the primary alternative action for prohibition, the primary alternative regulatory action also includes longer compliance timeframes for implementation of a 1-BP WCPP by non-Federal owners and operators. The primary alternative regulatory action does not include longer compliance timeframes for implementation of a 1-BP WCPP for Federal agencies and Federal contractors acting for or on behalf of the Federal Government. Under the primary alternative action, the requirements for the WCPP would take effect 6 months later than the proposed regulatory action for non-Federal owners and operators. Under a compliance timeframe that is 6 months longer than the proposed regulatory action, the requirements for non-Federal owners and operators to conduct initial baseline monitoring would take effect 12 months after the date of publication of the final rule in the
In contrast to the proposed non-prescriptive requirements of the WCPP, outlined in Unit IV.A.2., including requirements to meet an ECEL, where regulated entities would have the ability to select appropriate controls in accordance with the hierarchy of controls to comply with the performance-based parameters, EPA may also find it appropriate in certain circumstances to require specific prescriptive controls for certain occupational conditions of use. In the 2020 Risk Evaluation for 1-BP, EPA explained how engineering and administrative controls and use of PPE could reduce 1-BP exposures in occupational settings; therefore, EPA considered a combination of required engineering, administrative and PPE controls as the prescriptive approach in the primary alternative regulatory action for the following conditions of use: industrial and commercial use of solvent for cleaning and degreasing in vapor degreasers (batch vapor degreaser—open-top and, in-line vapor degreaser); and industrial and commercial use of solvent for cleaning and degreasing in vapor degreasers (batch vapor degreaser—closed-loop). Under the proposed regulatory action, these two conditions of use would be regulated under the WCPP.
When considering the use of required prescriptive engineering controls, administrative controls and PPE, EPA expects that such controls will be fully and properly implemented. Merely having the specified controls present is not sufficient to consider them “fully and properly” implemented. Rather, the regulated entities would be required to ensure that the controls are present and maintained, and that employees understand the proper use of those controls and use them accordingly. Examples of practices that would demonstrate that the regulated entities are in compliance with the controls would include proper installation and maintenance of the equipment according to manufacturer's instructions, timely replacement of filters and other similar parts, regular documented inspections to ensure equipment is operating properly, maintaining the required flow rates, and regular documented training to ensure proper use of controls.
For the condition of use of industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—open-top, inline vapor degreaser) EPA described in section 2.3.1.11 of the risk evaluation a local exhaust ventilation system for an open-top vapor degreaser (lateral exhaust hoods installed on two sides of the tank) that can reduce worker exposure. There are several limitations regarding use of ventilation systems, including uncertainties regarding the type of model used and the lack of monitoring data. Additionally, local exhaust ventilation systems may increase the volatilization of the solvent, leading to an increase in the use of solvent and the cost of operating the vapor degreaser. Also, a local ventilation system might require a Title V operating permit under the Clean Air Act and could require additional controls, such as the use of a carbon adsorber, to avoid emissions to the environment. As discussed in the proposed regulatory action (Unit IV.A.1.), EPA is proposing to require pollution prevention and source reduction wherever possible when making decisions about what control techniques to install. In addition, as indicated in the risk evaluation, a 90% reduction of 1-BP workplace emissions by using a local exhaust ventilation system is not enough to address the unreasonable risk to workers and occupational non-users. Additional controls would be needed, such as respirators with an APF of 50. Workers would also need gloves to reduce dermal exposures.
In Section 2.3.1.12 of the risk evaluation, EPA also identified a study indicating that air emissions can be reduced by 98% or more when a closed-loop degreaser is used instead of an open-top vapor degreaser (Ref. 1). Also, in the risk evaluation, EPA indicated that the unreasonable risk to workers when using a closed-loop degreaser could be addressed by using respirators with an APF of 10, but additional controls would be needed to reduce inhalation exposures to occupational non-users.
Therefore, under this primary alternative regulatory action, for the industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—open-top, inline vapor degreaser), EPA considered requirements to demonstrate reductions of emissions based on engineering controls and achieve an exposure concentration of less than 2.5 ppm (50 times the proposed ECEL value of 0.05ppm) as an 8-hour time-weighted average, isolate the vapor degreaser with controlled access to a “regulated area” where only workers who are wearing PPE to minimize exposures to 1-BP, and use of respirators with APF of 50 for any worker operating the vapor degreaser, would be permitted to go. EPA also considered requirements for use of gloves made of supported polyvinyl alcohol or a multiple-layer laminated material. EPA also considered requiring periodic monitoring (personal breathing zone or representative sample) every 3 months to determine that the respirators used are of a sufficient protection factor to be adequate to protect workers. In addition, EPA considered requiring that the regulated entity implement all aspects of a respiratory protection program (
Also as a primary alternative regulatory option, for the industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—closed-loop) EPA considered requiring regulated entities to: use closed-loop vapor degreasers with the adequate maintenance and a ventilation system or other engineering controls to achieve an exposure concentration of less than 0.5 ppm as an 8-hour time-weighted average; require isolation of the vapor degreaser in a “regulated area” with controlled access to minimize exposures to 1-BP; and require the use of respirators with APF of 10 for any worker in the vicinity of the vapor degreaser within the regulated area. EPA also considered requiring use of gloves made of supported polyvinyl alcohol or a multiple-layer laminated material. EPA also considered requiring periodic monitoring (personal breathing zone or representative sample) every 3 months to determine that the respirators used are adequate to protect workers. In addition, EPA considered requiring that the regulated entity implement all aspects of a respiratory protection program (
EPA also considered requiring the use of closed-loop vapor degreasers instead of open-top or inline vapor degreasers. EPA recognizes that using only closed-loop vapor degreasers can present several challenges to the regulated entities, depending on the size of the parts, the configuration of their operation and the time required to complete the cleaning operation. In addition, closed-loop vapor degreasers
For batch vapor degreasing (open-top and inline vapor degreasers) and cold cleaning, EPA also considered requiring engineering controls similar to the requirements set by the National Emission Standards for Halogenated Solvent Cleaning (40 CFR part 63, subpart T), which currently apply to other halogenated solvents but not 1-BP. EPA would expect that requirements under 40 CFR part 63, subpart T most likely would not reduce the 1-BP concentrations to 0.05 ppm as an 8-hour time-weighted average. Even if facilities were to install control measures to meet the requirements of 40 CFR part 63, subpart T, EPA believes that additional controls and PPE would be needed, including the use of gloves made of supported polyvinyl alcohol or a multiple-layer laminated material. Therefore, EPA is seeking comments regarding how the requirements of 40 CFR part 63, subpart T could be applied for 1-BP, as well as any additional information on how effective these requirements would be to reduce 1-BP air concentrations and additional controls needed to reduce 1-BP exposure to workers to 0.05 ppm as an 8-hour time-weighted average.
Under this primary alternative regulatory option, EPA considered requiring that the regulated entity engaged in any uses of 1-BP outlined in this Unit IV.B.1.c. develop an exposure control plan, as outlined in Unit IV.A.2.d.i., as well as comply with monitoring requirements, as outlined in Unit IV.2.A.b.ii., and recordkeeping requirements, as outlined in Unit IV.2.A.d.iv.
EPA also considered requiring that within 15 working days after receipt of the results of any exposure monitoring, the regulated entity must notify each person whose exposure is represented by that monitoring in writing, either individually to each person or by posting the information in an appropriate and accessible location. The notice would identify the exposure monitoring results, and any corresponding respiratory protection required. Also, the notice would be required to include a description of the actions taken by the regulated entity to reduce inhalation exposures or refer to a document available to the person which states the actions to be taken to reduce exposures.
Under the primary alternative regulatory action, EPA would apply prescriptive controls to reduce dermal exposures in the workplace and address the unreasonable risk of injury to health resulting from dermal exposures to 1-BP. Specifically, EPA is proposing that the owner or operator require the use of gloves for the following conditions of use: manufacturing (import); processing as a reaction; processing as incorporation into articles; repackaging, recycling; and disposal. As shown in Unit IV.C., which presents an overview of the proposed regulatory action and two alternative regulatory actions for each condition of use, the primary alternative action described in this document would subject the same occupational conditions of use to prescriptive dermal controls as the proposed regulatory action.
Regarding compliance timeframes, the primary alternative regulatory action would include longer timeframes for implementation of glove use by non-Federal owners and operators than the proposed regulatory action. Under the primary alternative action, prescriptive controls would generally take effect for non-Federal owners and operators 6 months later than in the proposed regulatory action. Under a compliance timeframe that is 6 months longer than the proposed regulatory action, the prescriptive controls for certain occupational conditions of use of 1-BP described in this unit would take effect for non-Federal owners and operators 12 months after the publication date of the final rule. The primary alternative regulatory action does not include longer compliance timeframes for implementation of these prescriptive controls for Federal agencies and Federal contractors acting for or on behalf of the Federal Government.
The primary alternative regulatory action considered by EPA would also require self-certification, as outlined in Unit IV.A.4., for the following occupational conditions of use: processing for incorporation into a formulation, mixture, or reaction products; industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—open-top, in-line); industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—closed-loop); industrial and commercial use as solvent for cleaning and degreasing in cold cleaners; industrial and commercial use as solvent in aerosol spray degreaser/cleaner; industrial and commercial use in other uses in electronic and electronic products and metal products, laboratory chemicals and asphalt extraction, and in coatings for temperature indicators. As shown in Unit IV.C., which presents an overview of the proposed regulatory action and two alternative regulatory actions for each condition of use, the primary alternative action described in this document would subject the same occupational conditions of use to self-certification requirements as the proposed regulatory action. While similar in most ways to the proposed regulatory action, the primary alternative regulatory action differs from the proposed regulatory action by requiring prescriptive controls rather a WCPP for two industrial and commercial conditions of use: industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—open-top, in-line); industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser (batch vapor degreaser—closed-loop). If the primary alternative regulatory action is chosen rather than the proposed regulatory action, EPA will update the self-certification statement to better align with whichever regulatory action is chosen.
The second alternative regulatory action described in this document and considered by EPA is to prohibit all occupational uses of 1-BP and the manufacture, processing, and
The second alternative regulatory action also would include a requirement that manufacturers, processors and distributors maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of the second alternative regulatory action; and to maintain such records for a period of 5 years from the date the record is generated. The recordkeeping requirements associated with this second alternative regulatory action would take effect 90 days after the effective date of the final rule.
Also, under this second alternative regulatory action, EPA would require that manufacturers, processors, and distributors, excluding retailers, of 1-BP provide downstream notification of the prohibitions through SDS by adding to sections 1(c) and 15 of the SDS the following language:
As of [DATE 90 DAYS AFTER OF PUBLICATION OF THE FINAL RULE], this chemical/product can only be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for use in insulation for building/construction materials.
The downstream notification requirements associated with this alternative approach would take effect 90 days after the effective date of the final rule in order to provide adequate time to undertake the changes to the SDS and ensure that all products in the supply chain include the revised SDS.
Table 2 is a side-by-side depiction of the proposed regulatory action with the primary and secondary alternative regulatory actions that EPA considered for each condition of use identified as driving the unreasonable risk (Ref. 2). The purpose of this table is to succinctly convey to the public certain differences between the proposed regulatory action and the alternative regulatory actions; as such the actions in each column are truncated and do not reflect all the details of the proposed and alternative regulatory actions, including differences in timeframes, as outlined in Units IV.A. and B. The proposed action and the alternative regulatory actions that EPA considered are described more fully in Units IV.A. and B.
This unit describes how the considerations described in Unit III.B.3. were applied when selecting among the TSCA section 6(a) requirements to arrive at the proposed and alternative regulatory actions described in Unit IV.
EPA considered a prohibition as a regulatory option and is proposing it for certain occupational conditions of use (Unit IV.A.). As described in this unit, EPA determined prohibition was appropriate for certain occupational conditions of use after taking into consideration other combinations of controls such as self-certification, a non-prescriptive WCPP, or prescriptive controls (
EPA also considered the potential for 1-BP use to increase in particular sectors, such as dry cleaning solvents, where it has largely been phased out because of its well-established hazard (Refs. 26, 3). In order to prevent the potential for use of 1-BP to increase in a sector that has already moved away from it, use of 1-BP for certain conditions of use would be prohibited under the proposed regulatory and alternative regulatory actions. Such uses of 1-BP include, but are not limited to, use as dry cleaning solvents, use in adhesives and sealants, and use in liquid cleaners and liquid spray/aerosol cleaners.
EPA determined prohibition would not be appropriate for the remaining occupational conditions of use, such as manufacturing (domestic manufacturing and import), processing as a reactant, processing for incorporation into articles, recycling, and repackaging; processing into a formulation, mixture, or reaction product; and industrial and commercial uses as a solvent for cleaning and degreasing in vapor degreasers, in aerosol spray degreaser/cleaner, in electronic and electronic products and metal products, in laboratory use for asphalt extraction, and in coating for temperature indicators. EPA made this determination based on compelling reasons, as described below, to not prohibit the activity and to identify a different regulatory action that would address the unreasonable risk. For example, prohibition may not be appropriate for conditions of use where EPA identified strict workplace controls could be implemented to address the unreasonable risk as described in Unit V.A.1.b. Additionally, prohibition may not be appropriate for conditions of use where alternative substances to 1-BP are more or equally hazardous (in particular some of the other solvents undergoing risk evaluation and risk management under TSCA section 6).
For these conditions of use, EPA determined restrictions under a 1-BP WCPP, self-certification requirements, prescriptive controls, or a combination of such requirements were more appropriate for addressing the unreasonable risk to the extent necessary so that 1-BP no longer presents such risk, while also allowing for regulated entities to continue operations, as described in this unit and in Unit IV.A.
Regarding industrial, commercial, and consumer uses of 1-BP, TSCA section 6(a)(2) provides EPA with the authority to prohibit or otherwise restrict the manufacture (including import), processing, or distribution in commerce of a substance or mixture “for a particular use” to ensure that a chemical substance no longer presents unreasonable risk. For this rulemaking, EPA proposes that “for a particular use” includes consumer use more broadly, as well as industrial and commercial use, which encompasses all known, intended, and reasonably foreseen uses of 1-BP. Given the severity and ubiquitous nature of the risks identified in the 2020 Risk Evaluation for 1-BP for all industrial, commercial, and consumer conditions of use (except in insulation), and noting that those conditions of use encompass all known, intended, and reasonably foreseen use of 1-BP, EPA proposes that prohibiting manufacture (including importing),
A key consideration regarding consumer uses is the role of retailers and other distributors. A retailer, as EPA has defined in 40 CFR 751.103 (and proposes to define in CFR 751.5), is any entity that makes available a chemical substance or mixture to consumer end users, including through e-commerce internet sales or distribution. Previously, in the 2019 methylene chloride TSCA section 6(a) risk management rule addressing consumer use of methylene chloride in paint and coating removal (Ref. 34), EPA prohibited retailers from distributing in commerce paint and coating removers containing methylene chloride (see 40 CFR 751.105(b) and (c)). To meet the same goal of protecting consumers from accessing products containing 1-BP that could pose unreasonable risks, for a broader range of consumer use, EPA considered and is proposing a similar provision to ensure that retailers will not be able to purchase 1-BP for sale or distribution to consumers and will not be able to sell or distribute 1-BP to consumers, including making available to consumers products containing 1-BP, except insulation. For these reasons, as described in Unit IV.A., EPA's proposal to address unreasonable risk from 1-BP includes prohibition on the distribution in commerce of 1-BP to and by retailers, except for the use of 1-BP in insulation.
One option EPA considered for occupational conditions of use was establishing a requirement for a 1-BP WCPP, which would include a combination of requirements to the extent necessary to address unreasonable risk contributed by inhalation and dermal exposures in the workplace. A 1-BP WCPP would encompass restrictions on certain occupational conditions of use and could include provisions for an ECEL and ancillary requirements to support implementation of these exposure limits. Due to the low exposure level and stringent requirements in the 1-BP WCPP that would be necessary to address the unreasonable risk from 1-BP, EPA identified those conditions of use where the Agency expected a 1-BP WCPP could be successfully implemented.
One requirement considered by EPA to include in a 1-BP WCPP to address unreasonable risk contributed by inhalation exposures to 1-BP for occupational conditions of use was establishing an ECEL and related implementation measures, such as exposure monitoring. As described in Unit IV.A., the 1-BP WCPP would be non-prescriptive, in the sense that regulated entities would not be required to use specific controls prescribed by EPA to achieve the exposure concentration limit. Rather, it would be a performance-based exposure limit that would enable owners or operators to determine how to most effectively meet the exposure limit based on conditions at their workplace, consistent with the hierarchy of controls.
A central component of the 1-BP WCPP is the exposure limit. EPA has determined as a matter of risk management policy that ensuring exposures remain at or below the ECEL will eliminate any unreasonable risk of injury to health from occupational inhalation exposures for those conditions of use subject to the WCPP.
In the case of 1-BP, EPA has calculated the ECEL to be 0.05 parts per million (ppm) (0.25 mg/m
In deciding whether an ECEL and related required implementation measures would appropriately address the unreasonable risk contributed by occupational inhalation exposures for specific conditions of use, EPA considered factors related to work activities that may make it difficult to comply with an ECEL, particularly at the low air concentration level EPA has identified. Once EPA identified the appropriate risk-based inhalation limit to address identified unreasonable risk, EPA carefully considered the appropriateness of such an exposure control program for each occupational condition of use of 1-BP, in the context of the unreasonable risk. Examples include conditions of use with work activities that may take place in the field, making it challenging to establish a regulated area and conduct monitoring; work activities that may take place in open systems that require manual contact with the chemical substance; work activities that may take place in small, enclosed spaces, creating challenges for implementing engineering controls or using respiratory PPE; work activities that require a high range of motion or for some other reason create challenges for the implementation of respiratory PPE; and the type of PPE that would be needed under the 1-BP WCPP to meet the ECEL in the absence of, or in addition to, other feasible exposure controls, based on analysis in the 2020 Risk Evaluation for 1-BP describing expected exposures with and without use of PPE.
EPA also considered the feasibility of exposure reduction sufficient to address the unreasonable risk, including in facilities complying with recommended OELs such as the ACGIH TLV. This creates a degree of uncertainty as to whether facilities engaging in some industrial and commercial conditions of use could meet the ECEL (and associated action level) and whether they could do so without relying primarily on the use of PPE (which is the least preferred option in the hierarchy of controls), and, therefore, whether exposures could be reduced in a manner aligned with the hierarchy of controls.
EPA understands that this uncertainty extends to the feasibility of respirators to address unreasonable risk from 1-BP as well. Although respirators, specifically SCBAs, could reduce exposures to levels that protect against non-cancer and cancer risks, not all workers may be able to wear respirators. Individuals with impaired lung function
Another requirement considered by EPA to include in a 1-BP WCPP to address unreasonable risk driven by exposures to 1-BP for occupational conditions of use was requiring a prescriptive PPE program. The requirements under this prescriptive program are a process-based set of provisions to address unreasonable risk driven by workplace exposures to 1-BP. In order to address workplace exposures to 1-BP, requirements would include use of prescriptive PPE, including dermal PPE. EPA's description for how the requirements related to this prescriptive PPE program would address the unreasonable risk resulting from workplace exposures and the rationale for this regulatory approach is outlined in Units III.B.3. and V.A.
Similar to the ECEL, under prescriptive PPE requirements, EPA is proposing to require owners and operators to implement respiratory controls in accordance with the hierarchy of controls, as outlined in Unit IV.A.2.c. EPA also recommends and encourages the use of pollution prevention as a means of controlling exposures whenever practicable.
In contrast to the proposed non-prescriptive requirements of the ECEL, EPA is proposing to require owners and operators to implement specific prescriptive controls for those occupational conditions of use subject to a 1-BP WCPP. Specifically, EPA is proposing to require the use of chemically resistant gloves made of supported polyvinyl alcohol or a multiple-layer laminated material, in combination with specific activity training (
In consideration of the whole of the 2020 Risk Evaluation for 1-BP, including the uncertainties, EPA has preliminarily determined that preventing workplace exposure to 1-BP through prescriptive PPE requirements, including the use of respirators and/or gloves, workplace specific training, and PPE training, as described in Unit IV.A.2.c., for certain occupational conditions of use would address the unreasonable risk from 1-BP exposures in the workplace driven by these conditions of use for potentially exposed persons.
Taking into account these considerations, EPA is proposing that certain conditions of use would be allowed to continue if regulated entities could ensure exposures remain at or below the ECEL and other requirements are met in the 1-BP WCPP. In contrast to considerations that would weigh against the likelihood that a facility within a condition of use to successfully implement a WCPP, there are certain considerations that indicate a facility engaged in a condition of use would likely be able to achieve effective risk management via WCPP. Based on reasonably available information, including monitoring data process descriptions, and information related to considerations described previously in this unit, EPA's confidence that requirements to meet an ECEL can be implemented is highest in highly standardized and industrialized settings, such as where 1-BP is used in a closed system (Ref. 32). For example, two industry commenters provided EPA with closed system process and exposure monitoring information that indicate circumstances where the requirements to meet an ECEL could be successfully implemented (Ref. 32).
Pursuant to TSCA section 6(c)(2)(A)(i), EPA is considering reasonably available information regarding the adverse effects of 1-BP on human health and the magnitude of exposure of human beings to 1-BP. EPA recognizes that people at workplaces that manufacture, process, use, or dispose of 1-BP may live in the fenceline communities surrounding these facilities and consequently may be potentially exposed to 1-BP through ambient air outside of working hours. In addition, the Agency understands that certain engineering controls can reduce exposure to people inside the workplace but may lead to increased ventilation of 1-BP outside of the workplace, thereby increasing risks to people in fenceline communities of adverse health effects from exposure to 1-BP in ambient air. Therefore, pursuant to TSCA section 6(c)(2)(B), EPA is considering the potential adverse effects on health of people in fenceline communities posed by emissions of 1-BP to ambient air described in Unit VI. as a factor when proposing to prohibit increased releases of 1-BP to outdoor air associated with the implementation of the WCPP. This proposed requirement is intended to avoid unintended increases in exposures to people from 1-BP emissions to ambient air. The proposed rule would require owners and operators to attest in their WCPP exposure control plan that engineering controls selected to address worker risk do not increase emissions of 1-BP to ambient air outside of the workplace and document in their exposure control plan whether additional equipment was installed to capture emissions of 1-BP to ambient air.
Details of the proposed 1-BP WCPP, including provisions for the ECEL and ancillary required implementation measures, requirements for demonstrating compliance, and requirements for distributors, are described in more detail in Unit IV.A. EPA requests comment on all aspects of this proposal to allow certain conditions of use to continue under the WCPP, including the likelihood that the provisions of the WCPP, including exposure monitoring, engineering and administrative controls, PPE, and the exposure control plan, could be successfully implemented for the identified conditions of use, including, for example, the industrial and commercial use as a solvent for aerosol spray degreaser/cleaner.
In addition to the considerations addressed in Unit V.A.1.b., EPA is also proposing prescriptive controls to reduce dermal exposures in the workplace and address the unreasonable risk of injury to health resulting from dermal exposures to 1-BP. Specifically, EPA is proposing the use of chemically resistant gloves, either made of supported polyvinyl alcohol or a multiple-layer laminated material, supplied by the owner or operator, for certain occupational conditions of use where dermal exposure is expected to result in unreasonable risk, but for which there is no unreasonable risk
Since it is unlikely that all industrial or commercial facilities with occupational exposures engaged in one or more uses of 1-BP as listed in Unit IV.A.2. have the ability to implement a WCPP, EPA is including a point-of-sale self-certification requirement in order to purchase 1-BP for certain uses. EPA is proposing that this self-certification would be required for the conditions of use, other than domestic manufacturing, that would be allowed to continue for regulated entities under the WCPP. This would allow only those entities within those conditions of use that could ensure that exposures remain at or below the ECEL and meet other requirements of the 1-BP WCPP to continue to process or use 1-BP for those particular conditions of use. EPA estimates that most, but not all, workplaces under the conditions of use that would be subject to the WCPP as a proposed regulatory action are capable of implementing the ECEL and other aspects of the WCPP as part of an industrial hygiene program (existing or newly established for 1-BP), since many of these facilities would have the ability to implement process changes to reduce exposures, have equipment in place to control ventilation rates, and have or can implement a monitoring program to demonstrate compliance. However, EPA does not expect that all workplaces would be able to implement fully all the controls and monitoring necessary to comply with the WCPP to reduce the risks from 1-BP so that they are no longer unreasonable. Subjecting facilities to self-certification would ensure that only those facilities that are able to implement the ECEL and other requirements of the WCPP would be able to continue to purchase 1-BP for a condition of use subject to the 1-BP WCPP.
Under a self-certification requirement, entities would submit a self-certification to the distributor each time 1-BP is purchased. The self-certification would consist of a statement indicating that the facility is implementing a WCPP that would include an ECEL, PPE requirements, and ancillary requirements; the self-certification would be signed and presented to the distributor by the facility owner or operator or person authorized to do so. In this way, distributors of 1-BP for the specified conditions of use would be able to identify clearly the entities engaging in the specified conditions of use who should be able to purchase 1-BP. Additionally, while not required to be reported to EPA, the self-certification records would be retained for 5 years and would also provide important information to EPA during any verification of compliance with the WCPP.
Details of the proposed self-certification, including ancillary recordkeeping requirements, requirements for demonstrating compliance and requirements for distributors, are described in more detail in Unit IV.A.
EPA acknowledges that, for two of the occupational conditions of use (industrial and commercial use in batch vapor degreasing—open-top and in-line; industrial and commercial use in batch vapor degreasing—closed-loop) that EPA is proposing to subject to a WCPP, there may be some activities or facilities that could conceivably implement prescriptive controls to ensure that exposures remain below an ECEL. In some cases, they may be able to undertake more extensive risk reduction measures than EPA currently anticipates. As described in Unit IV.B.1.b., under a 1-BP WCPP owners and operators would have more ability to implement risk reduction measures that may be better suited for their facility rather than subjecting facilities to specific required prescriptive controls that may not be the most suitable for all. Therefore, as a primary alternative regulatory action, described in Unit IV.B., EPA is considering and requesting comment on prescriptive controls and the implementation of a PPE program. Additionally, EPA is requesting any existing monitoring data that could inform whether a WCPP or prescriptive controls with a PPE program is a more appropriate regulatory action for these two conditions of use of 1-BP.
EPA understands that some of the workplaces engaged in a condition of use may already have stringent engineering controls, administrative controls, and PPE in place to reduce inhalation and dermal exposures to 1-BP, such as vapor degreasing. As part of the primary alternative regulatory action, EPA considered prescribed engineering controls, administrative controls, and PPE for the two occupational conditions of use. In contrast to the proposed non-prescriptive requirements of the WCPP where regulated entities would have flexibility to select controls in accordance with the hierarchy of controls to comply, EPA understands that requiring specific prescriptive controls for certain occupational conditions of use may provide greater certainty to some facilities that they are addressing the unreasonable risk. However, as summarized in this unit, EPA has uncertainty regarding the feasibility of exposure reductions through specified engineering controls, administrative controls, and/or PPE to address unreasonable risk across all workplaces engaged in certain conditions of use. Prescribing specific engineering controls, administrative controls, or PPE does not consider distinctions in processes, equipment, or workplace layout in all facilities, which may result in varying levels and types of controls needed to reduce inhalation exposures to below the ECEL. Additionally, as described in Unit V.A.1.b., there is a degree of uncertainty regarding applicability of respirators, including their feasibility and consistency of proper use, especially when exposure monitoring is not regularly conducted. However, as part of the primary alternative regulatory action, EPA is considering PPE and soliciting comment on prescribing specific engineering and administrative controls for some occupational conditions of use. In the 2020 Risk Evaluation for 1-BP, EPA identified PPE that could reduce exposures and therefore considered requiring PPE, including respiratory protection and dermal protection, as part of the primary alternative regulatory action for those certain conditions of use where the proposed regulatory action is a 1-BP WCPP. Turning to the use of PPE, however, does not consider other more preferable controls in the hierarchy of controls, including elimination, substitution, engineering, and administrative controls. As part of the primary alternative regulatory action, EPA is soliciting comment on prescribing specific engineering or administrative controls that would reduce inhalation and dermal exposures enough to address the unreasonable risk across all workplaces engaged in a condition of use.
EPA also considered a prohibition as a second alternative regulatory option for all manufacturing (including import), processing, industrial and commercial use, and disposal of 1-BP, except for the use of 1-BP and products containing 1-BP in building/construction materials (insulation). EPA
EPA acknowledges that, for some conditions of use for which it is considering prohibition under the second alternative regulatory option, there may be some activities or facilities that would need longer compliance timeframes in order to appropriately transition. Therefore, the second alternative regulatory action also considered providing for additional time under a prohibition to provide the flexibility for facilities to comply, for example, to account for issues affecting the supply chain, such as the ready availability of alternatives to reformulate products. In selecting among the TSCA section 6(a) requirements for the second alternative regulatory action for use of 1-BP-containing products, EPA considered risk-related factors, including but not limited to, the population exposed and the severity of the hazard of 1-BP and, separately, for other alternative solvents, which are undergoing risk evaluation and risk management under TSCA section 6, such as PCE (as part of a separate rulemaking). For example, there may be instances where PCE and 1-BP may be desired because they are non-flammable solvents used as cleaning agents for use in vapor degreasing. In these instances, additional time may be needed to identify an alternative chemical or process to avoid flammability concerns.
Details of the primary alternative regulatory action and second alternative regulatory action are described in more detail in Unit IV.B.
EPA considered but is not proposing to regulate the weight fraction of 1-BP in products for industrial and commercial or consumer use because 1-BP is the main constituent (
EPA's proposed requirements to address unreasonable risk to workers, ONUs, and consumers and bystanders to consumer use are described in Unit IV.A.
After considering the different regulatory options under TSCA section 6(a), alternatives (described in Unit V.B.), compliance dates, and other requirements under TSCA section 6(c), EPA developed the proposed regulatory action described in Unit IV.A. to address the unreasonable risk from 1-BP to the extent necessary so that the risk is no longer unreasonable. To ensure successful implementation of this proposed regulatory action, EPA considered other section 6(a) requirements to support compliance with the proposed regulations, such as requiring monitoring and recordkeeping to demonstrate compliance with the 1-BP WCPP and downstream notification regarding the prohibition on manufacturing, processing, distribution in commerce, and use of 1-BP, including products containing 1-BP, for certain conditions of use. These proposed requirements are described in Unit IV.A.
As required under TSCA section 6(d), any rule under TSCA section 6(a) must specify mandatory compliance dates, which shall be as soon as practicable with a reasonable transition period, but no later than 5 years after the date of promulgation of the final rule (except in the case of a use exempted under TSCA section 6(g) or for full implementation of ban or phase-out requirements). For ban or phase-out requirements, EPA must specify mandatory compliance dates for the start of ban or phase-out requirements, which must be as soon as practicable but no later than 5 years after the date of promulgation of the final rule. These compliance dates are detailed in Unit IV.A. and IV.B. EPA may finalize significantly shorter or longer compliance timeframes based on consideration of public comments. Following Panel recommendations in the SBAR report, and described in Unit IV., EPA considered reasonable compliance timeframes in response to SER input and other appropriate factors, such as capital costs for new equipment, and ongoing regulations and rulemakings, including the addition of 1-BP to the list of (HAPs under the Clean Air Act (January 5, 2022; 87 FR 393) (Ref. 20). Additionally, following Panel recommendations in the SBAR report, EPA considered compliance timelines based on the availability of technically and economically feasible alternatives, as well as any information provided by other agencies that may set requirements for certification or standards relevant to degreasing, parts cleaning, or other uses of 1-BP. Following Panel recommendations in the SBAR report, EPA is requesting comment on any additional appropriate factors for identifying reasonable compliance timeframes and how to weigh the factors for degreasing and other industries, as well as differing compliance or reporting requirements or timetables that account for the resources available to small entities.
Under TSCA section 6(c)(2)(C), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, EPA must consider, to the extent practicable, whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. To that end, in addition to an Economic Analysis (Ref. 3), EPA conducted an Alternatives Assessment, using reasonably available information (Ref. 35).
For this assessment, EPA identified and analyzed alternatives to 1-BP in products relevant to industrial, commercial, and consumer conditions of use proposed to be prohibited or restricted, even if such restrictions are not anticipated to substantially prevent the condition of use. Based on reasonably available information, including information submitted by the industry, EPA understands viable alternatives to 1-BP may not be available for several conditions of use—for example, processing 1-BP as a raw material in chemical reactions for the manufacturing of another chemical substance or product—and considered that information to the extent practicable in the development of the regulatory options as described in Unit III.B.3. For some conditions of use, EPA was unable to identify products currently available for sale that contain 1-BP. EPA is soliciting comments on whether there are products in use or available for sale relevant to these conditions of use that contain 1-BP at this time, so that EPA can ascertain whether there are alternatives that benefit human health or the environment as compared to such use of 1-BP. These conditions of use are detailed in the Alternatives Assessment (Ref. 35).
In deciding whether to propose prohibition or other significant restrictions on a condition of use of 1-BP and in proposing an appropriate transition period for any such action, EPA has therefore, pursuant to TSCA section 6(c)(2)(C), considered, to the extent practicable, whether technically and economically feasible alternatives that benefit human health or the environment, compared to the use proposed to be prohibited or restricted, would be reasonably available as a substitute when a proposed prohibition or other significant restriction would become effective. EPA is additionally requesting comment on the Alternatives Assessment as a whole.
EPA's analysis of the health effects of 1-BP and the magnitude of human exposure to 1-BP are in the 2020 Risk Evaluation for 1-BP (Ref. 1). A summary is presented here.
The 2020 Risk Evaluation for 1-BP identified potential health effects of 1-BP including non-cancer adverse health effects such as liver toxicity, kidney toxicity, reproductive toxicity, developmental toxicity, and neurotoxicity. Relative to cancer effects, the risk evaluation identified cancer hazards from genotoxicity, a recognized mechanism of cancer, and site-specific cancers, particularly for skin, intestinal, and lung tumors. EPA has determined that protecting at the cancer endpoint would also address the risk for other acute or chronic non-cancer endpoints.
For acute inhalation and dermal exposure scenarios, EPA identified non-cancer developmental effects as the most sensitive endpoint. For chronic inhalation and dermal exposure scenarios, EPA identified the following health effects: liver (increased hepatocellular vacuolization), kidney (increased pelvic mineralization), reproductive system (decreased seminal vesicle weight), developmental effects (decreased live litter size and post-implantation loss), and nervous system (decreased traction time) as the most sensitive endpoints. By the criteria presented in EPA's Guidelines for Carcinogen Risk Assessment (Ref. 30), 1-BP is characterized as “likely to be carcinogenic to humans by all routes of exposure” based on the positive findings for carcinogenicity in more than one test species, together with positive findings for the direct reactivity of 1-BP with DNA and suggestive but inconclusive evidence for genetic toxicity. In a two-year cancer bioassay with 1-BP exposures via the inhalation route, increases in the incidence of skin tumors (keratoacanthoma/squamous cell carcinomas) in male F344 rats, rare large intestine adenomas in female F344 rats, and alveolar/bronchiolar adenomas or carcinomas (combined) in female B6C3F1 mice were observed (Ref.1).
Regarding the magnitude of human exposure, one factor EPA considers for the conditions of use that contribute to unreasonable risk is the size of the exposed population which, for 1-BP, EPA estimates that, annually, there are between approximately 4,147 and 8,131 workers and between 2,310 and 4,709 ONUs at between 716 and 1,627 commercial operations either processing or using products containing 1-BP (Ref. 3). The number of consumers that use products containing 1-BP each year is likely to be few because EPA found that products containing 1-BP aren't typically marketed to consumers and several products that might have been marketed to consumers are being discontinued.
For the conditions of use that contribute to the unreasonable risk for 1-BP, PESS include workers, ONUs, consumer users, and bystanders to consumers using products containing 1-BP. PESS also includes the following life stages: people of reproductive age, pregnant women, infants, and children.
In addition to workers, ONUs, consumers, and bystanders to consumer use directly exposed to 1-BP, EPA recognizes there is exposure to the general population from the ambient air pathway for 1-BP, including fenceline communities. As mentioned in Unit II.D., EPA has separately conducted a screening approach to assess whether there may be potential risks to the general population from this exposure pathway. While the use of this screening approach indicates that EPA is not able to quantify reduced risk or find that there are no potential risks to fenceline communities, the screening approach was not designed to facilitate the making of an unreasonable risk determination for these communities. This unit summarizes the results of that fenceline analysis. EPA is not making a determination of unreasonable risk based on the fenceline screening analysis, however, the proposed regulatory action described in Unit IV., in combination with EPA's designation of 1-BP as a HAP (87 FR 393) and subsequent CAA-required NESHAPs, particularly for vapor degreasing, is expected to reduce risk.
As described in Unit II.D., EPA's fenceline analysis methodology was presented to the SACC peer review panel in March 2022, and EPA considered SACC feedback (including the SACC recommendation to EPA to consider multiple years of release data to estimate exposures and associated risks) and made decisions regarding how to assess general population exposures. For 1-BP, EPA recognizes that a key input into the fenceline analysis for the ambient air pathway was data on releases from the most recent Toxics Release Inventory (TRI) reporting year and that the use of more than one year of data could result in different conclusions. Accordingly, in this unit EPA presents the results of its ambient air pathway fenceline analysis based on 1-BP releases reported to TRI over a single reporting year as well as over multiple years. Additionally, analysis of the facilities identified with risk show no co-located facilities (Ref. 36).
EPA's fenceline analysis for the air pathway for 1-BP indicates that EPA is not able to conclude that there are no potential risks to fenceline communities, described further in this unit. Additionally, based on the fenceline analysis for the ambient air pathway for 1-BP, including the strengths, limitations, and uncertainties associated with the information used to inform the analysis, EPA is unable to determine with this analysis whether those risks contribute to the unreasonable risk of injury to health presented by 1-BP. Standard cancer benchmarks used by EPA and other regulatory agencies are an increased cancer risk above benchmarks ranging from 1 in 1,000,000 to 1 in 10,000 (
In this unit, EPA presents the results of its ambient air pathway fenceline analysis and the uncertainties associated with the analysis. EPA also describes how the proposal to prohibit the manufacturing (include importing), processing, and distribution in commerce of 1-BP for certain industrial and commercial use and all consumer use, and to prohibit some industrial and commercial use of 1-BP, is expected to reduce the potential risks identified in the screening analysis to fenceline communities close to facilities engaging in 1-BP use. This unit also describes how EPA believes the proposed WCPP requirements may reduce exposures to the general population for facilities identified in the fenceline analysis with expected exposures to fenceline communities that are associated with conditions of use EPA is not proposing to prohibit. EPA also believes that with the proposed prohibitions of some conditions of use, risk is expected to be reduced for certain fenceline communities. EPA therefore does not intend to revisit the air pathway for 1-BP as part of a supplemental risk evaluation.
In January 2022, 1-BP was added to the HAP list under the CAA (87 FR 393), which also requires EPA to list source categories of HAPs, set standards for all HAPs that are emitted from each source category, and review and revise these standards, if necessary, to account for improvements in air pollution controls and/or prevention, including addition of any recently added HAPs that may be applicable to the standard being reviewed. As NESHAPs continue to be reviewed, and as the majority of facilities assessed, and those which indicate potential risk, in the fenceline analysis were vapor degreasing facilities, the NESHAPs process under the CAA will assess risk to the general population at the fenceline and regulate as necessary.
There are some uncertainties associated with the fenceline analysis for the air pathway for 1-BP. The TRI dataset used for the single- and the multi-year fenceline analysis and land use analysis does not include actual release point locations, which can affect the estimated concentrations of the chemical at varying distances modeled. To identify the release location for each facility, EPA used a local-coordinate system based on latitude/longitude coordinates reported in TRI. The latitude/longitude coordinates may represent the mailing address location of the office building associated with a very large facility or some other area of the facility rather than the actual release location (
EPA's single year fenceline analysis for the ambient air pathway, based on methods presented to the SACC, evaluated 1-BP releases to TRI over the 2019 reporting year. This single year fenceline analysis identified 71 facilities with some indication of releases and potential exposure with associated cancer risk to people within select distances evaluated from 5 to 1,000 meters from the respective releasing facility. Separately, following SACC feedback, EPA applied a slightly modified pre-screening methodology to evaluate 5 years of 1-BP release data (2016 through 2020 TRI data as well as the 5-year average of that data) rather than a single year of data for facilities with reported releases in TRI. The multi-year fenceline analysis identified 105 facilities with some indication of releases and potential exposures and associated cancer risk in excess of 1 × 10
EPA conducted a land use analysis to determine if EPA can reasonably expect an exposure to fenceline communities to occur within the modeled distances for facilities where there was an indication of risk in the single year or multi-year fenceline analysis. This review consisted of a visual analysis using aerial imagery and interpreting land/use zoning practices spaces are present within those radial distances indicating risk (as opposed to uninhabited areas), as well as whether the radial distances lie outside the boundaries of the facility. The land use analysis identified 49 facilities indicating risk in the single-year fenceline analysis and identified 35 out of the 49 facilities with expected exposure to fenceline communities. The land use analysis of the 34 additional facilities indicating risk in the multi-year fenceline analysis (
Under the proposed regulatory action described in Unit IV.A., most of the conditions of use with an indication of potential risk to fenceline communities would be subject to requirements of the 1-BP WCPP, including: manufacturing; several processing conditions of use; and several industrial conditions of use. EPA is also proposing to prohibit certain conditions of use that may be associated with 2 of the 47 facilities analyzed with an indication of potential risk to fenceline communities in the fenceline analysis, including: dry cleaning and functional fluids. As a result, exposures to any fenceline communities from these facilities would be addressed under the prohibitions in the proposed rulemaking.
The remaining facilities with expected exposure to fenceline communities may be associated with the following conditions of use that EPA is not proposing to prohibit: manufacturing (domestic manufacture); processing as a reactant; processing for incorporation into formulation, mixture, or reaction products; processing for incorporation into articles; industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser—closed loop; industrial and commercial use as solvent for cleaning and degreasing in vapor degreaser—open-top, inline vapor degreaser; and, industrial and commercial use as solvent for cleaning and degreasing in cold cleaners. For these conditions of use that may be associated with facilities that indicate expected exposure to fenceline communities, the proposed rule would require strict workplace exposure controls via implementation of a WCPP as described in Unit IV.A.2. Under the proposed WCPP requirements, facilities would need to monitor 1-BP air concentrations by taking personal breathing zone air samples of potentially exposed persons, which would allow facilities to better understand and manage the total releases of 1-BP within the facility and potentially stack and fugitive emissions. Furthermore, as part of the proposed controls outlined in Unit IV., EPA is proposing to prohibit increased releases of 1-BP to outdoor air associated with the implementation of the WCPP to avoid unintended increases in exposures to people (in the workplace and fenceline communities) from 1-BP emissions to ambient air by requiring owners to attest in their WCPP exposure control plan that engineering controls selected do not increase emissions of 1-BP to ambient air outside of the workplace, keep records of that statement as part of the WCPP exposure control plan, and document in their exposure control plan whether additional equipment was installed to capture or otherwise prevent increased emissions of 1-BP to ambient air. EPA is requesting comment on best practices to remove and reduce fugitive emissions of 1-BP from relevant operations including, but not limited to, chemical manufacturing, vapor degreasing, electronics degreasing, cold cleaning, and adhesives manufacturing. EPA is requesting comment on the types and costs of technologies firms would adopt to comply with the prohibition on increased releases of 1-BP to outdoor air associated with engineering controls used in the implementation of the WCPP. In addition, EPA requests comment on whether and to what extent certain technologies, including technologies that might be implemented pursuant to applicable regulatory authority (such as emission standards resulting from possible future NESHAP requirements), would reduce 1-BP emissions to ambient air at facilities that adopt them below emissions levels that may have existed prior to implementation of the WCPP.
Finally, in the instances where efforts to reduce exposures in the workplace to levels below the ECEL could lead to adoption of engineering controls that that may result in more 1-BP being ventilated outside, EPA believes this potential additional exposure would be limited as a result of anticipated revisions to NESHAP requirements following the designation of 1-BP as a HAP under the CAA.
EPA expects that this proposed action, in combination with the emissions standards resulting from anticipated revisions to NESHAP requirements following the designation of 1-BP as a HAP, would reduce risk sufficiently to the general population and fenceline communities. EPA does not intend at this time to revisit the air pathway for 1-BP as part of a supplemental risk evaluation. EPA is seeking comment on its conclusions, and whether, consistent with TSCA section 9(b), any other statutory authorities administered by EPA should be used to take additional regulatory action identified as necessary to protect against such risk. EPA is also soliciting comment on whether EPA should require ambient air monitoring, including fenceline monitoring, at fenceline locations or facility emissions source monitoring to demonstrate compliance with the proposed requirement that engineering controls implemented as part of a WCPP under this rulemaking would not result in the ventilation of more 1-BP outside. The Agency recognizes that owners and operators may have difficulty distinguishing between emission increases due to implementation of the WCPP and emissions increases resulting from other factors such as increased manufacturing, processing, or use of 1-BP, although monitoring at both upwind and downwind locations could help them do so. In addition, EPA understands the difficulty in distinguishing between background levels of 1-BP and emissions from facilities. Therefore, EPA is soliciting comment on the need for and associated costs of ambient air monitoring at fenceline locations and facility emissions source monitoring, as well as information on the frequency and nature of air monitoring EPA should consider including as requirements in the final rule (such as a detection limit for 1-BP). EPA is also requesting comment on methods to inform fenceline communities of any increases of 1-BP emissions to ambient air. EPA is also soliciting comment on whether, if EPA does not finalize the proposed prohibition on increased releases of 1-BP to ambient air outside of the workplace associated with implementation of the WCPP, EPA should require monitoring to alert EPA to any increased emissions to ambient air associated with WCPP implementation so that the Agency may take appropriate action.
EPA's analysis of the environmental effects of 1-BP and the magnitude of exposure of the environment to 1-BP are in the 2020 Risk Evaluation for 1-BP (Ref. 1). The unreasonable risk determination for 1-BP is based solely on risks to human health; based on the TSCA 2020 Risk Evaluation for 1-BP, EPA determined that exposures to the environment did not contribute to the unreasonable risk from 1-BP. A summary is presented here.
EPA considered the effects of 1-BP on aquatic, sediment dwelling, and terrestrial organisms. EPA found that there were no exceedances of benchmarks to aquatic organisms from exposures to 1-BP. Based on a consideration of the physical-chemical properties and uses of 1-BP, exposure to aquatic species is the only route of exposure to the environment that was quantitatively assessed in the risk evaluation. Risks to terrestrial and sediment-dwelling aquatic species were qualitatively evaluated by considering
EPA considered uncertainties in its determination of unreasonable risk for 1-BP to the environment. While EPA has determined that sufficient data are reasonably available to characterize the overall environmental hazards of 1-BP under the conditions of use, there are uncertainties regarding the available environmental hazard data for 1-BP. High volatility (Vapor Pressure = 110 mm Hg and Henry's Law constant of 7.3 × 10
1-BP has a wide range of uses, including as a solvent for cleaning and degreasing (
The reasonably ascertainable economic consequences of this proposed rule include several components, all of which are described in the Economic Analysis for this proposed rule (Ref. 3). With respect to the anticipated effects of this proposed rule on the national economy, EPA considered the number of businesses and workers that would be affected and the costs and benefits to those businesses and workers and did not find that there would be an impact on the national economy (Ref. 3). The economic impact of a regulation on the national economy becomes measurable only if the economic impact of the regulation reaches 0.25% to 0.5% of Gross Domestic Product (GDP). Given the current GDP, this is equivalent to a cost of $40 billion to $80 billion. Therefore, because EPA has estimated that the monetized cost of the proposed rule would range from $14.8 million annualized over 20 years at a 3% discount rate and $15.5 million annualized over 20 years at a 7% discount rate, EPA has concluded that it is highly unlikely this proposed rule would result in any measurable effect on the national economy (Ref. 3). In addition, EPA considered the employment impacts of this proposed rule, and found that the direction of change in employment is uncertain, but EPA expects the short-term and longer-term employment effects would be small.
There are an estimated 931 small entities affected by the proposed option with a per firm and total estimated cost impact of $13 thousand and $12 million, respectively. Of the small businesses potentially impacted by this proposed rule, 88% are expected to have impacts of less than 1% of their firm revenues, 7% are expected to have impacts between 1 and 3% of their firm revenues, and 5% are expected to have impacts greater than 3% of their firm revenues.
Users of 1-BP in vapor degreasing could be strongly impacted because they may have no economical alternative to the use of 1-BP.
No incremental costs beyond the cost of rule familiarization are estimated for users of 1-BP products that are prohibited under the proposed rule. Users are assumed to switch to alternatives with similar costs and efficacy. As noted in section 7.12 of the EA, there may be some applications where 1-BP is more effective, reducing labor time and wait time, and this analysis was unable to quantify those costs. For example, there may be some safety-critical applications where alternatives would need to undergo extensive safety review and testing before they could replace the 1-BP products. The impact of a prohibition of 1-BP for these uses could potentially result in important negative impacts of the proposed option, but EPA was unable to quantify any of these potential impacts, so cost impacts to potentially affected small businesses could not be estimated.
With respect to this proposed rule's effect on technological innovation, EPA expects this action to spur more innovation than it will hinder. A prohibition or significant restriction on the manufacture, processing, and distribution in commerce of 1-BP for uses covered in this proposed rule may increase demand for safer chemical substitutes. This proposed rule is not likely to have significant effects on the environment because 1-BP does not present an unreasonable risk to the environment, though this proposed rule does present the potential for small reductions in air emissions associated with improper disposal of products containing 1-BP. The effects of this proposed rule on public health are estimated to be positive, due to the reduced risk of cancer and other non-cancer endpoints from exposure to 1-BP.
The costs and benefits that can be monetized for this proposed rule are described at length in the Economic Analysis (Ref. 3). The monetized costs for this proposed rule are estimated to range from $14.8 million annualized over 20 years at a 3% discount rate and $15.5 million annualized over 20 years at a 7% discount rate. The monetized benefits are estimated to be $27.2 million annualized over 20 years at a 3% discount rate and $12.9 million annualized over 20 years at a 7% discount rate.
EPA considered the estimated costs to regulated entities as well as the cost to administer and enforce alternative regulatory actions. The primary and second alternative regulatory actions are described in detail in Unit IV.B. The estimated annualized costs of the primary alternative regulatory action are $14.4 million at a 3% discount rate and $15.0 million at a 7% discount rate over 20 years (Ref. 3). The estimated annualized costs of the second alternative regulatory action are $181.2 million at a 3% discount rate and $250.1 million at a 7% discount rate over 20 years. The monetized benefits of the primary alternative action are estimated to be $27.2 million annualized over 20 years at a 3% discount rate and $12.9 million annualized over 20 years at a 7% discount rate (Ref. 3). The monetized benefits of the second alternative action are estimated to be $27.2 million annualized over 20 years at a 3% discount rate and $13.0 million annualized over 20 years at a 7% discount rate. For the proposed rule, as described in the Economic Analysis, EPA assumes that all vapor degreasing and batch cold cleaning users can comply with a WCPP. However, some users may require supplied air respirators to comply with the WCPP and it may be impractical for some workers to perform their jobs using these types of respirators. Since we estimate substitution away from 1-BP to be much more expensive than complying with a WCPP, our estimated costs could be several times higher than our current estimate if a WCPP is impractical for many users.
This proposal is expected to achieve health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot be monetized. EPA believes that the balance of costs and benefits of this proposal cannot be fairly described without considering the additional, non-monetized benefits of mitigating the cancer and non-cancer adverse effects. These effects may include liver toxicity, kidney toxicity, reproductive effects possibly including reduction in fertility, developmental effects possibly including fetal loss and low birth weight, and neurotoxicity including peripheral neuropathy (Ref. 1). Peripheral neuropathy has been documented in workers chronically exposed to high levels of 1-BP in spray adhesives.
Fetal loss, also referred to as fetal death or fetal mortality, includes miscarriage, spontaneous abortion, or stillbirth, depending on when in the pregnancy it occurs. The impacts of fetal death, including miscarriage or stillbirth, include mental health impacts, such as depression and anxiety on the woman experiencing the death of a fetus, and can also impact partners and spouses (Ref. 3). Mental health research has consistently identified both miscarriage (defined as fetal death occurring before the 20th week of gestation) and stillbirth (defined as fetal death occurring after the 20th week of gestation) as a significant emotional burden exhibited as anxiety and depression that can persist; research suggests women and men feel effects for more than a year, women can feel effects nearly three years following the event of fetal death and after the birth of a healthy child, which emphasizes effects can persist significantly longer beyond the event (Ref. 3).
EPA also identified risks of reduction in fertility as an effect resulting from exposures to 1-BP (Ref. 1). While impacts from 1-BP exposure on fertility and fecundity cannot be quantified at this time with available data, for couples seeking treatment for infertility, costs of such treatment are often significant both financially and emotionally. The most comprehensive and appropriate value for benefit-cost analysis is willingness to pay. There are few studies for the reduced risk of infertility, but a recent study estimates a willingness to pay of $102,000 per statistical case of infertility avoided (Ref. 3). EPA also identified risks of low-birth weight by women of child-bearing age exposed to 1-BP as another health effect of concern. Low birth weight can have significant impacts on childhood development and the incidence of future diseases; reduced birth weight can cause serious health problems for some children, as well as long-term impacts on their lives as adults (Ref. 3).
The multitude of adverse effects from 1-BP exposure can profoundly impact an individual's quality of life, as discussed in Units II.A. (overview), III.B.2. (description of the unreasonable risk), and VI.A. (discussion of the health effects), as well as the 2020 Risk Evaluation for 1-BP. Chronic adverse effects of 1-BP exposure include both cancer and the non-cancer effects addressed in Unit VI.A. Acute effects of 1-BP exposure could be experienced for a shorter portion of life but are nevertheless significant in nature. The incremental improvements in health outcomes achieved by given reductions in exposure cannot be quantified for non-cancer health effects associated with 1-BP exposure, and therefore cannot be converted into monetized benefits. The qualitative discussion throughout this rulemaking and in the Economic Analysis highlights the importance of these non-cancer effects. These effects include willingness-to-pay to avoid illness, which includes cost of illness and other personal costs such as pain and suffering. Considering only monetized benefits underestimates the impacts of 1-BP adverse outcomes and therefore underestimates the benefits of this proposed rule. EPA requests comment on how EPA might best quantify and monetize non-cancer endpoints described in the 2020 Risk Evaluation for 1-BP for economic analysis.
Cost effectiveness is a method of comparing certain actions in terms of the expense per item of interest or goal. A goal of this proposed regulatory action is to prevent unreasonable risk resulting from exposure to 1-BP. The proposed regulatory action would cost $3.2 million per potential prevented cancer case while the primary alternative regulatory action would cost $3.1 million (using the 3% discount rate) and the second alternative regulatory action would cost $38.8 million to achieve the same goals. At a 7% discount rate, the proposed regulatory action would cost $3.3 million per potential prevented cancer case while the primary alternative regulatory action would cost $3.2 to million, and the second alternative regulatory action would cost $53.6 to million to achieve the same goals. While the proposed regulatory action is higher in cost compared to the primary alternative action, the difference is small (Ref. 3).
TSCA section 9(a) provides that, if the Administrator determines, in the Administrator's discretion, that an unreasonable risk may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA, the Administrator must submit a report to the agency administering that other law that describes the risk and the activities that present such risk. Section 9(a) describes additional procedures and requirements to be followed by EPA and the other Federal agency following submission of any such report. As discussed in this unit, for this proposed rule, the Administrator proposes to exercise discretion not to determine that the unreasonable risk from 1-BP under the conditions of use may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA.
In addition, TSCA section 9(d) instructs the Administrator to consult and coordinate TSCA activities with other Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burdens of duplicative requirements. For this proposed rule, EPA has and continues to coordinate with appropriate Federal executive departments and agencies including OSHA and the Consumer Product Safety Commission (CPSC) to, among other things, identify their respective authorities, jurisdictions, and existing laws with regard to 1-BP, which are summarized in this unit.
OSHA requires that employers provide safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance. However, gaps exist between OSHA's authority to set workplace standards under the OSH Act and EPA's obligations under TSCA section 6 to eliminate unreasonable risk presented by chemical substances under the conditions of use. Health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only “to the extent feasible.” 29 U.S.C. 655(b)(5). To set PELs for chemical exposure, OSHA must first establish that the new standards are economically and technologically feasible (79 FR 61384, 61387, Oct. 10, 2014). But under TSCA section 6(a), EPA's substantive burden is to demonstrate that, as regulated, the chemical substance no longer presents an unreasonable risk, with unreasonable risk being determined without consideration of costs or other nonrisk factors. Thus, if OSHA were to initiate a new action to establish a PEL for 1-BP, the difference in standards between the OSH Act and TSCA may well result in the OSHA PEL being set at a higher level than the exposure limit that EPA determined would be sufficient to address the unreasonable risk under TSCA.
In addition, OSHA may set exposure limits for workers, but its authority is limited to the workplace and does not extend to consumer uses of hazardous chemicals, and thus OSHA cannot address the unreasonable risk from 1-BP under all of its conditions of use, which include consumer uses. OSHA also does not have direct authority over State and local employees, and it has no authority over the working conditions of State and local employees in States that have no OSHA-approved State Plan under 29 U.S.C. 667.
CPSC, under authority provided to it by Congress in the CPSA, protects the public from unreasonable risks of injury or death associated with the use of consumer products. Under the CPSA, CPSC has the authority to regulate 1-BP in consumer products, but not in other sectors such as automobiles, industrial and commercial products, or aircraft, for example. Further, a consumer product safety rule under the CPSA must include a finding that “the benefits expected from the rule bear a reasonable relationship to its costs,” 15 U.S.C. 2058(f)(3)(E), whereas EPA must apply TSCA risk management requirements to the extent necessary so that the chemical no longer presents unreasonable risk and only consider costs and benefits of the regulatory action to the extent practicable, 15 U.S.C. 2605(a), (c)(2). Additionally, the 2016 amendments to TSCA reflect Congressional intent to “delete the paralyzing `least burdensome' requirement,” 162 Cong. Rec. S3517 (June 7, 2016), a reference to TSCA section 6(a) as originally enacted, which required EPA to use “the least burdensome requirements” that protect “adequately” against unreasonable risk, 15 U.S.C. 2605(a) (1976). However, a consumer product safety rule under the CPSA must impose “the least burdensome requirement which prevents or adequately reduces the risk of injury for which the rule is being promulgated.” 15 U.S.C. 2058(f)(3)(F). Analogous requirements, also at variance with recent revisions to TSCA, affect the availability of action CPSC may take under the Federal Hazard Substances Act (FHSA) relative to action EPA may take under TSCA. 15 U.S.C. 1262. EPA's substantive burden under TSCA section 6(a) is to apply requirements to the extent necessary so that the chemical substance no longer present the unreasonable risk that was determined in accordance with TSCA section 6(b)(4)(A) without consideration of cost or other non-risk factors.
EPA therefore concludes that TSCA is the only regulatory authority able to prevent or reduce unreasonable risk of 1-BP to a sufficient extent across the range of conditions of use, exposures and populations of concern. This unreasonable risk can be addressed in a more coordinated, efficient and effective manner under TSCA than under different laws implemented by different agencies. Moreover, the timeframe and any exposure reduction as a result of updating OSHA or CPSC regulations cannot be estimated, while TSCA requires a much more accelerated 2-year statutory timeframe for proposing and finalizing regulatory requirements to address unreasonable risk. Further there are key differences between the finding requirements of TSCA and those of the OSH Act, CPSA, and FHSA. For these reasons, in the Administrator's discretion, the Administrator proposes not to determine that unreasonable risk from 1-BP may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA. However, EPA is requesting public comment on this issue (
If EPA determines that actions under other Federal laws administered in whole or in part by EPA could eliminate or sufficiently reduce a risk to health or the environment, TSCA section 9(b) instructs EPA to use these other authorities to protect against that risk unless the Administrator determines in the Administrator's discretion that it is in the public interest to protect against such risk under TSCA. In making such a public interest finding, TSCA section 9(b)(2) states: “the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of the risk and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk.”
Although several EPA statutes could be used to limit 1-BP exposure (Ref. 6), regulations under those EPA statutes would have limitations with respect to addressing the unreasonable risk of injury to human health presented by 1-BP as identified in the 2020 Risk Evaluation because they largely regulate
The primary exposures and unreasonable risk to consumers, bystanders, workers, and ONUs would be addressed by EPA's proposed prohibitions and restrictions under TSCA section 6(a). In January 2022, EPA added 1-BP to the HAP list under the CAA (87 FR 393). Section 112 of the CAA requires that EPA identify categories of sources that emit HAPs and then promulgate emission standards that address the emissions of all HAPs emitted from the source category. Section 112 also requires EPA to review promulgated standards at least every 8 years and to revise such standards, if necessary, to account for improvements in air pollution controls and/or pollution prevention. Technology reviews typically include an evaluation of developments in HAP control technologies or other methods of reducing HAP emissions, adjustments to emissions testing and monitoring approaches, and updates to ensure that rules are consistent with recent court decisions and other relevant issues related to the CAA section 112 rulemaking program. Further, CAA section 112 requires EPA to conduct a residual risk review to assess human health and environmental risks associated with the HAP emitted from the source category being reviewed. It is intended to ensure that public health is protected with an ample margin of safety. EPA has generally treated the risk review as a one-time requirement for each source category, but EPA has authority to conduct subsequent reviews, and sometimes does so, for example, if new information, such as a new toxicological assessment showing the increased potency of a chemical, warrants a new residual risk assessment. As part of these reviews, the EPA is required to set standards for any unregulated HAPs emitted from the source category under review, including any newly listed HAP. Since the listing of 1-BP in 2022, EPA has conducted reviews of the standards promulgated for some source categories and has looked for potential emissions of 1-BP. None of these categories were found to emit 1-BP and, therefore, EPA has not yet promulgated standards for 1-BP under CAA section 112. As other NESHAP reviews continue as part of the 8-year review cycle, including for the halogenated solvents source category for vapor degreasing facilities that constitute the majority of facilities assessed in the 1-BP fenceline analysis, the NESHAPs process under the CAA will assess risk to the general population, including people living in near proximity to facilities in the source categories. These reviews are intended to provide an ample margin of safety to protect public health consistent with statutory requirements. All source categories will be reviewed and EPA will set CAA section 112 standards that regulate 1-BP if it is found to be emitted from the source category under review. This includes the halogenated solvents source category. This rulemaking under TSCA is more appropriate to address the unreasonable risk of injury to human health and the environment presented by 1-BP as identified in the 2020 Risk Evaluation. None of EPA's other statutes (
For these reasons, the Administrator does not determine that unreasonable risk from 1-BP under the conditions of use evaluated in the 2020 TSCA Risk Evaluation for 1-BP could be eliminated or reduced to a sufficient extent by actions taken under other Federal laws administered in whole or in part by EPA.
EPA is also providing notice to manufacturers, processors, and other interested parties about potential impacts to CBI that may occur if this action is finalized as proposed. Under TSCA section 14(b)(4), if EPA promulgates a rule pursuant to TSCA section 6(a) that establishes a ban or phase-out of a chemical substance, the protection from disclosure of any CBI regarding that chemical substance and submitted pursuant to TSCA will be “presumed to no longer apply,” subject to the limitations identified in TSCA section 14(b)(4)(B)(i) through (iii). If this action is finalized as proposed, then pursuant to TSCA section 14(b)(4)(B)(iii), the presumption against protection from disclosure would apply only to information about the specific conditions of use that this rulemaking would prohibit or phase out. Manufacturers or processors seeking to protect such information would be able to submit a request for nondisclosure as provided by TSCA sections 14(b)(4)(C) and 14(g)(1)(E). Any request for nondisclosure would need to be submitted within 30 days after receipt of notice from EPA under TSCA section 14(g)(2)(A). EPA anticipates providing such notice via the Central Data Exchange (CDX).
In accordance with TSCA section 26(h), EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science. As in the case of the unreasonable risk determination, risk management decisions for this proposed rule, as discussed in Unit III.B.3. and Unit V., were based on a risk evaluation that was subject to public comment and independent, expert peer review, and was developed in a manner consistent with the best available science and based on the weight of the scientific evidence as required by TSCA sections 26(h) and (i) and 40 CFR 702.43 and 702.45.
In particular, the ECEL value incorporated into the WCPP is derived from the analysis in the 2020 Risk Evaluation for 1-BP; it likewise represents decisions based on the best available science and the weight of the scientific evidence (Refs. 12, 38, 39). The ECEL value of 0.05 ppm as an 8-hour TWA is based on the chronic cancer inhalation unit risk (IUR) at a risk level of 1 × 10
The extent to which the various information, procedures, measures, methods, protocols, methodologies or models, as applicable, used in EPA's decisions have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for this rulemaking. Additional information on the peer review and public comment process, such as the peer review plan, the peer review report, and the Agency's response to comments, can be found at EPA's risk evaluation docket at EPA-HQ-OPPT-2016-0741 (Ref. 32).
EPA is requesting public comment on all aspects of this proposal, including the proposed and alternative regulatory actions and all individual elements of these, and all supporting analysis. Additionally, within this proposal, the Agency is soliciting feedback from the public on specific issues throughout this proposed rule. For ease of review, this
1. EPA is requesting public comment on all elements of the proposed regulatory action and the alternative regulatory actions.
2. EPA is requesting comment on all elements of the IRFA, and, in particular the flexibilities that EPA has identified following input from the SERs during the SBAR process.
3. EPA is requesting public comment regarding the need for exemptions from the proposed requirement (and under what specific circumstances) pursuant to the provisions of TSCA section 6(g).
4. EPA requests public comment on whether EPA should promulgate definitions for the conditions of use covered by the 2020 Risk Evaluation for 1-BP that would not be prohibited, and, if so, whether the descriptions in Unit II.B. are consistent with the conditions of use evaluated in the 2020 Risk Evaluation for 1-BP and whether they provide a sufficient level of detail to improve the clarity and readability of the regulation if EPA were to promulgate a regulation that contains a list of the industrial and commercial conditions of use evaluated in the 2020 Risk Evaluation for 1-BP. Additionally, EPA is requesting comment regarding the number of businesses or other entities that could potentially close, as well as associated costs, with a prohibition of 1-BP for certain industrial and commercial conditions of use identified in this proposed rule.
5. EPA also requests comment on whether, rather than just excluding the consumer and commercial uses of 1-BP in insulation from the prohibitions and other requirements in this risk management rulemaking, EPA should more broadly exclude the use of articles under TSCA section 6(c)(2)(E), which would also exclude the use of 1-BP in articles that were not specifically evaluated in the 2020 Risk Evaluation for 1-BP, and if so, whether and how to define “article” for the purposes of this rulemaking.
6. EPA requests comment on the proposed compliance dates for prohibitions of 1-BP manufacturing, processing, distribution in commerce, and use and whether additional time is needed, for example, for products to clear the channels of trade, or for implementing substitutes; comments should include documentation such as the specific use of the chemical throughout the supply chain; concrete steps taken to identify, test, and qualify substitutes for those uses (including details on the substitutes tested and the specific certifications that would require updating); and estimates of the time required to identify, test, and qualify substitutes with supporting documentation. EPA also requests comment on whether these are the appropriate types of information for use in evaluating compliance requirements, and whether there are other considerations that should apply.
7. EPA would also like comment on whether it should consider a de minimis level of 1-BP in formulations for certain continuing industrial and commercial uses to account for impurities when finalizing these prohibitions, and, if so, what process and product formulations should be considered when evaluating a de minimis calculation to ensure exposure risk is removed.
8. EPA is requesting comment on commercial distribution channels or systems that would allow for distribution to commercial users while preventing retailers from making these products available to consumers, or feasible distribution channels for commercial users that have been developed in analogous situations, including information on whether there are market barriers to such systems.
9. EPA is soliciting comment regarding an ECEL action level that is lower than the ECEL and any associated provisions related to the ECEL action level.
10. EPA requests comment on the feasibility of complying with and monitoring for an ECEL of 0.05 ppm and an ECEL action level of 0.03 ppm, including occupational exposure monitoring and associated analytical methods. In particular, EPA requests comment on changes that may be needed in order to meet such a standard, for example changes related to elimination or substitution of 1-BP, engineering controls, process changes, or monitoring frequency. EPA is also interested in the information on the availability of laboratory capacity needed to meet the proposed standard, and the costs associated with such testing.
11. EPA is soliciting comments regarding the timing of the initial exposure monitoring so that it would be representative of all tasks involving 1-BP where exposures may approach the ECEL.
12. EPA requests comment on the timeframes for periodic monitoring outlined in Table 1 of Unit IV.A.2.
13. EPA requests comment on workplace monitoring for implementation of an ECEL. EPA is soliciting information related to the frequency of monitoring, initial monitoring, and periodic monitoring that would be needed to demonstrate workplace exposure levels. Specifically, when this may impact the frequency of periodic monitoring where initial monitoring shows that employee exposures are above the level that would initiate requirements for compliance with the ECEL.
14. EPA is requesting comment on the proposed timeframe of within 30 days to conduct additional exposure monitoring after there has been a change in the production, process, control equipment, personnel or work practices that may reasonably be expected to result in new or additional exposures at or above the ECEL action level, or when the owner or operator has any reason to believe that new or additional exposures at or above the ECEL action level have occurred.
15. EPA is also requesting comment on the proposed timeframe to conduct additional exposure monitoring after the cleanup of the spill or repair of the leak, rupture or other breakdown, as outlined in Unit IV.A.2.
16. EPA is requesting comment on how the proposed requirement that owners or operators attest that the engineering controls selected do not increase emissions of 1-BP to ambient air outside of the workplace may impact the availability, feasibility, or cost of engineering controls as a means to reduce workplace exposures to or below the proposed ECEL.
17. EPA is soliciting comment on requiring warning signs to demarcate regulated areas, such as the requirements found in OSHA's General Industry Standard for Beryllium.
18. EPA is requesting comment on whether there should be a requirement to replace cartridges or canisters after a certain number of hours, such as the requirements found in OSHA's General Industry Standard for 1,3-Butadiene, or a requirement for a minimum service life of non-powered air-purifying respirators such as the requirements found in OSHA's General Industry Standard for Benzene.
19. EPA is requesting comment on how owners and operators can engage with potentially exposed persons on the development and implementation of an exposure control plan and PPE program. EPA is also requesting comment on whether EPA should include designated representatives who can also be permitted to observe exposure monitoring and have regular access to exposure-related information at the request of potentially exposed persons.
20. EPA requests comment relative to the ability of owners or operators to conduct initial monitoring within the timeframes identified in this proposed rule, and anticipated timelines for any procedural adjustments needed to comply with the requirements outlined
21. EPA also requests comment on whether additional time is needed to implement all aspects of the WCPP or if there are available substitutes for these applications.
22. EPA is soliciting comments on the requirements proposed for appropriate PPE selection. In addition, EPA understands that some workplaces rinse and reuse PPE after minimal use and is therefore soliciting comments on the impact on effectiveness of rinsing and reusing certain types of PPE, either gloves or protective clothing and gear. EPA also requests comment on the degree to which additional guidance related to use of PPE might be appropriate.
23. EPA requests comment on establishing a self-certification requirement, and/or reporting requirements, for purchasing and continued use of 1-BP or products containing 1-BP for certain conditions of use. For example, EPA seeks comment on whether, in future rulemakings, it should require reporting to EPA of the type of records specified in 40 CFR 751.815.
24. EPA requests comment on reasonable compliance timeframes for small businesses, including timeframes for reformulation of products or processes containing 1-BP; implementation of new engineering or administrative controls; changes to labels, SDSs, and packaging; implementation of new PPE requirements, including training and monitoring practices; and supply chain management challenges. EPA also requests comment on establishing differing compliance or reporting requirements or timetables that take into account the limited resources available to small entities.
25. EPA requests comments on the appropriateness of identified compliance timeframes for recordkeeping and downstream notification requirements described in this proposed rule.
26. EPA requests comment on the primary alternative regulatory action (a combination of prohibitions, requirements for a WCPP, prescriptive controls, self-certification, and glove use) and whether any elements of this primary alternative regulatory action described in this proposed rule should be considered as EPA develops the final regulatory action. In particular, EPA is soliciting comment on prescribing specific engineering or administrative controls that would reduce inhalation exposures enough to address the unreasonable risk across all workplaces engaged in a condition of use. EPA also requests comment on any advantages or drawbacks for the timelines outlined in Unit IV.B. compared to the timelines identified for the proposed regulatory action in Unit IV.A.
27. EPA is requesting comment on the ways in which 1-BP may be used in the following conditions of use: manufacturing (domestic); processing into formulation, mixture, or reaction products; industrial and commercial use as solvent for cleaning and degreasing in cold cleaners; industrial and commercial use as solvent in aerosol spray degreaser/cleaner; and industrial and commercial use in other uses in electronic and electronic products and metal products; laboratory chemicals for asphalt extraction; coatings for temperature indicator, including whether activities may take place in a closed system and the degree to which users of 1-BP in these sectors could successfully implement an ECEL and ancillary requirements described in Unit IV.A.
28. EPA requests comment on the second alternative regulatory action (prohibition of all uses of 1-BP, except for the commercial and consumer uses in insulation) and whether any elements of this second alternative regulatory action described in Unit IV.B. should be considered as EPA develops the final regulatory action. EPA also requests comment on any advantages or drawbacks for the timelines outlined in Unit IV.B. compared to the timelines identified for the proposed regulatory action in Unit IV.A.
29. Each non-Federal owner or operator would be required to provide respiratory protection to all potentially exposed persons in the regulated area within 3 months after receipt of the results of any exposure monitoring or within 9 months after date of publication of the final rule in the
30. EPA requests comment on the amount of time needed, for example, for vapor degreasers, to transition to an alternative process or solvent. EPA also requests comment regarding the number of entities that could potentially close as identified in the proposed rule.
31. EPA is seeking comments regarding how the requirements of 40 CFR part 63, subpart T could be applied for 1-BP, as well as any additional information on how effective these requirements would be to reduce 1-BP air concentrations and additional controls needed to reduce 1-BP exposure to workers to 0.05 ppm as an 8-hour time-weighted average.
32. EPA is requesting comment on the second alternative regulatory action and whether any elements of this second alternative regulatory action described in this unit should be considered as EPA develops the final regulatory action. EPA also requests comment on any advantages or drawbacks for the timelines outlined in this unit compared to the timelines identified for the proposed regulatory action in Unit IV.A.
33. EPA requests comment on providing an option of either complying with the ECEL or implementing various administrative and engineering controls, such as those uses employed in a closed-loop system. EPA also requests information on how a small business can demonstrate that such controls eliminate the unreasonable risk for uses of 1-BP in closed-loop systems, or other types of vapor degreasers.
34. EPA requests comment on all aspects of the proposal to allow certain conditions of use to continue under the WCPP, including the likelihood that the provisions of the WCPP, including exposure monitoring, engineering and administrative controls, PPE, and the exposure control plan, could be successfully implemented for the identified conditions of use, including, for example, the industrial and commercial use as a solvent for aerosol spray degreaser/cleaner.
35. EPA is requesting comment on specific controls that would mitigate the unreasonable risk from 1-BP and that could be included as part of a prescriptive workplace controls requirement, which could be considered as EPA develops the final regulatory action. Specifically, EPA is soliciting comment on combinations of specific engineering controls, administrative controls, and PPE that would reduce inhalation exposures to at or below the ECEL of 0.05 ppm as an 8-hour TWA for all workplaces where such controls would be required. EPA also is soliciting comment on the extent to which such requirements could reduce inhalation exposures to at or below the ECEL of 0.05 ppm as an 8-hour TWA. EPA is requesting comment on the compliance timeframe needed to implement engineering controls, administrative controls, and PPE that reduce inhalation exposures to at or
36. EPA is soliciting comments on whether, for those product types relevant to industrial, commercial, and consumer conditions of use proposed to be prohibited or significantly restricted, where EPA was unable to identify products currently available for sale that contain 1-BP, there are products in use or available for sale relevant to these conditions of use that contain 1-BP at this time, so that EPA can ascertain whether there are alternatives that benefit human health or the environment as compared to such use of 1-BP.
37. EPA is requesting comment on the Alternatives Assessment as a whole.
38. EPA is requesting comment on the types and costs of technologies firms would adopt to comply with the prohibition on increased releases of 1-BP to outdoor air associated with engineering controls used in the implementation of the WCPP. Additionally, EPA requests comment on whether and to what extent certain control technologies, including technologies that might be implemented pursuant to applicable regulatory authority (such as emission standards resulting from possible future NESHAP requirements), would reduce 1-BP ambient air emissions at facilities that adopt them below emissions levels that existed prior to implementation of the WCPP.
39. EPA is requesting public comment on its TSCA Section 9(a) Analysis described in Unit VII.A., (
40. EPA is requesting comment on the need for and associated costs of ambient air monitoring, including fenceline monitoring, at fenceline locations; or facility emissions source monitoring, as well as information on the frequency and nature of air monitoring EPA should consider including as requirements in the final rule (such as a detection limit for 1-BP). EPA is also requesting comment on methods to inform fenceline communities of any increases of 1-BP emissions to ambient air.
41. EPA is requesting comment on whether, if EPA does not finalize the proposed prohibition on increased releases of 1-BP to ambient air outside of the workplace associated with implementation of the WCPP, EPA should require monitoring to alert EPA to any increased emissions to ambient air associated with WCPP implementation so that the Agency may take appropriate action.
42. EPA requests comment on whether owners and operators should be required to attest to whether and why the exposure controls they have selected would not result in increased releases of 1-BP to ambient air from the workplace, and keep records of that statement as part of the WCPP exposure control plan.
43. EPA is requesting comment on best practices for controlling fugitive emissions and associated costs of monitoring and controlling facility emissions to eliminate or reduce fenceline releases. This can include best workplace hazard control practices that EPA should consider including as requirements in the final rule.
44. EPA requests comment on how EPA might best quantify and monetize non-cancer endpoints described in the 2020 Risk Evaluation for 1-BP for economic analysis.
45. Following Panel report recommendations and in response to input provided by SERs, EPA is requesting comment on the following topics as outlined in the SBAR Panel Report (Ref. 23):
• EPA requests public comment on the extent to which a regulation under TSCA section 6(a) could minimize requirements, such as testing and monitoring protocols, recordkeeping, and reporting requirements.
• EPA requests comment on the methodology and inputs for the ECEL value that are directly derived from the peer reviewed analysis in the August 2020 Risk Evaluation.
• EPA requests comment on reasonable compliance timeframes for small businesses.
• EPA requests comment on differing compliance or reporting requirements or timetables that account for the resources available to small entities.
• EPA requests public comment about the feasibility of entities complying with and monitoring for a potential ECEL of 0.05 ppm. Specifically, EPA aims to obtain more information on potential costs that could be incurred using strategies to meet the requirements of such a standard, such as engineering, administrative, or prescriptive controls and how feasible it would be for entities to implement these strategies in their operations.
• EPA requests comment on providing an option of either complying with the ECEL or implementing various administrative and engineering controls, such as those employed in a closed-loop system, including information on how a small business can demonstrate that such controls eliminate the unreasonable risk for that use.
• EPA requests public comment about the feasibility of the use of alternatives to 1-BP and their availability for conditions of use that contribute to the unreasonable risk.
• EPA requests comment on temporary work practices to allow for limited circumstances, including but not limited to equipment failure or maintenance activity, where monitoring may not be feasible to comply with an ECEL. EPA requests information on the extent to which 1-BP may be used in the same facility for TSCA and non-TSCA uses.
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not itself physically located in the docket. For assistance in locating these other documents, please consult the person listed under
1. EPA. Risk Evaluation for 1-Bromopropane. August 2020.
2. EPA. Final Revised Unreasonable Risk Determination for 1-Bromopropane (1-BP) December 19, 2022.
3. EPA. Economic Analysis of the Proposed Regulation of 1-Bromopropane Under TSCA Section 6(a). July 2024.
4. EPA. Chemical Data Reporting. 2016.
5. EPA. Chemical Data Reporting. 2020.
6. EPA. Regulatory Actions Pertaining to 1-Bromopropane. July 2024.
7. OSHA. Standard Interpretations: 8-hour total weight average (TWA) permissible exposure limit (PEL).
8. NIOSH. Hierarchy of Controls.
9. EPA. 1-Bromopropane (1-BP); Draft Revision to Toxic Substances Control Act (TSCA) Risk Determination; Notice of Availability and Request for Comment.
10. U.S. Army Public Health Command. Information Regarding 1-Bromopropane and the Adopted Notice of Intended Change (Threshold Limit Value Decrease from 10 ppm to 0.1 ppm).
11. OSHA. Enforcement Policy for Respiratory Hazards Not Covered by OSHA Permissible Exposure Limits. November 2, 2018.
12. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational Use of 1-Bromopropane (1-BP). March 2, 2021.
13. G. Ichihara, et al. Neurologic Abnormalities in Workers of a 1-Bromopropane Factory.
14. NIOSH. Hazard Alert. October 2014.
15. EPA. EPA Announces Path Forward for TSCA Chemical Risk Evaluations. June 30, 2021.
16. Executive Order 13985. Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.
17. Executive Order 13990. Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.
18. Executive Order 14008. Tackling the Climate Crisis at Home and Abroad.
19. EPA. Science Advisory Committee on Chemicals 1-Bromopropane Meeting Minutes and Final Report. September 10-12, 2019.
20. EPA. Notes from Federalism Consultation on Forthcoming Proposed Rulemakings for Methylene Chloride and 1-Bromopropane under TSCA Section 6(a). October 22, 2020.
21. EPA. Notes from Tribal Consultations on Forthcoming Proposed Rulemakings for Methylene Chloride and 1-Bromopropane under TSCA Section 6(a). November 12 & 17, 2020.
22. EPA. Environmental Justice Consultation on Forthcoming Proposed Rulemakings under TSCA Section 6(a). November 16 & 19, 2020.
23. Small Business Advocacy Review Panel. Small Business Advocacy Review Panel on EPA's Planned Proposed Rule under the Toxic Substances Control Act (TSCA) Section 6(a) for 1-Bromopropane (1-BP). December 16, 2021.
24. EPA. Initial Regulatory Flexibility Analysis for 1-Bromopropane; Regulation under the Toxic Substances Control Act (TSCA); Proposed Rule; RIN 2070-AK73. August 2023.
25. EPA. Materials for September 2020 1-Bromopropane Risk Management Webinar.
26. EPA. Stakeholder Meeting List for Proposed Rulemaking for 1-Bromopropane under TSCA Section 6(a).
27. EPA. 2021 Policy on Children's Health. October 5, 2021.
28. EPA. Problem Formulation of the Risk Evaluation for 1-Bromopropane. May 2018.
29. EPA. Supplemental Information on Occupational Exposure Assessment. August 2019.
30. EPA. Guidelines for Carcinogen Risk Assessment. March 2005.
31. OSHA. Occupational Exposure to Methylene Chloride.
32. EPA. Summary of External Peer Review and Public Comments and Disposition for 1-Bromopropane (n-Propyl Bromide). August 2020.
33. OSHA. Personal Protective Equipment. 2004.
34. EPA. Final Rule. Methylene Chloride; Regulation of Paint and Coating Removal for Consumer Use Under TSCA Section 6(a).
35. EPA. Alternatives Assessment for Use of 1-Bromopropane. July 2023.
36. EPA. 1-Bromopropane: Fenceline Technical Support—Ambient Air Pathway. June 16, 2023.
37. EPA. Final Rule. National Emission Standards for Hazardous Air Pollutants; Benzene Emissions From Maleic Anhydride Plants, Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke ByProduct Recovery Plants.
38. EPA. 1-Bromopropane (1-BP): Risk Management Support Documents. [DATE].
39. EPA. Risk Management for 1-Bromopropane Supplemental File: Consumer Risk Calculator. [DATE].
40. EPA. Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA); Regulation of 1-Bromopropane under TSCA Section 6(a) (Proposed Rule). EPA ICR No. 2785.01; OMB Control No. 2070-NEW. [DATE].
41. Kevin Ashley. Harmonization of NIOSH Sampling and Analytical Methods with Related International Voluntary Consensus Standards.
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 (58 FR 51735 October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023). Accordingly, EPA submitted this action to OMB for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an economic analysis (Ref. 3) of the potential costs and benefits associated with this action, which is available in the docket and is summarized in Unit VI.D.
The information collection activities in this proposed rule have been submitted to OMB for review and comment under the PRA, 44 U.S.C. 3501
There are four primary provisions of the proposed rule that may increase burden under the PRA. The first is downstream notification, which would be carried out by updates to the relevant SDS and which would be required for manufacturers, processors, and distributors in commerce of 1-BP, who would provide notice to companies downstream upon shipment of 1-BP about the prohibitions. The information submitted to downstream companies through the SDS would provide knowledge and awareness of the restrictions to these companies. The second primary provision of the proposed rule that may increase burden under the PRA is WCPP-related information generation, recordkeeping, and notification requirements (including development of exposure control plans; exposure level monitoring and related recordkeeping; development of documentation for a PPE program and related recordkeeping; development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, exposure monitoring records, PPE program documentation). The third primary provision of the rule that may increase burden under the PRA are requirements related to prescriptive controls recordkeeping and notification (including development and retention of records necessary for implementing use of prescriptive controls (
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.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this proposed rule. EPA will respond to ICR-related comments in the final rulemaking. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at
As required by section 609(b) of the RFA, 5 U.S.C. 601
Pursuant to section 603 of the RFA, EPA prepared an IRFA (Ref. 24) that examines the impact of the proposed rule on small entities along with regulatory alternatives that could minimize that impact. The complete IRFA is available for review in the docket and is summarized here.
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines after a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a PESS identified as relevant to the risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. 1-BP was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in August 2020. In addition, in December 2022, EPA issued a revised unreasonable risk determination that 1-BP as a whole chemical substance presents an unreasonable risk of injury to health under the conditions of use. As a result, EPA is proposing to take action to the extent necessary so that 1-BP no longer presents such risk.
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must by rule apply one or more requirements listed in section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. EPA has determined through a TSCA section 6(b) risk evaluation that 1-BP presents an unreasonable risk under the conditions of use.
The proposed rule potentially affects small manufacturers (including importers), processors, distributors, retailers, users of 1-BP or of products containing 1-BP, and entities engaging in disposal. EPA estimates that the proposal would affect approximately 931 small entities. End users with economic and technologically feasible alternatives available do not have estimated cost impacts beyond rule familiarization costs.
To address the unreasonable risk EPA has identified, EPA is proposing to: prohibit the manufacture (including import), processing, and distribution in commerce of 1-BP for all consumer use, excluding the use of 1-BP in insulation; prohibit certain industrial and commercial uses and the manufacture (including import), processing and distribution in commerce of 1-BP for those uses; require a 1-BP WCPP, which would include requirements to meet an inhalation exposure concentration limit, for certain conditions of use; require self-certification for certain occupational conditions of use; require the use of gloves for certain occupational conditions of use; and establish recordkeeping and downstream notification requirements. There are an estimated 931 small entities affected by the proposed option with a per firm cost of $13 thousand with a total estimated cost impact of $12 million. This includes $12.0 million for WCPP use and $0.1 million for uses that are prohibited. No incremental costs beyond the cost of rule familiarization are estimated for users of 1-BP products that are prohibited under the proposed rule. Users are assumed to switch to alternatives with similar costs and efficacy. As noted in section 7.12 of the EA, there may be some applications where 1-BP is more effective, reducing labor time and wait time, and this analysis was unable to quantify those costs. For example, there may be some safety-critical applications where alternatives would need to undergo extensive safety review and testing before they could replace the 1-BP products. The impact of a prohibition of 1-BP for these uses could potentially result in important negative impacts of the proposed option, but EPA was unable to quantify any of these potential impacts, so cost impacts to potentially affected small businesses could not be estimated.
EPA is proposing to prohibit certain conditions of use. For most other conditions of use that contribute to the unreasonable risk determination for 1-BP, EPA proposes to address the unreasonable risk with a 1-BP WCPP, which would include a combination of requirements to address unreasonable risk contributed by inhalation. A 1-BP WCPP would encompass restrictions on certain occupational conditions of use and could include provisions for an ECEL, a PPE program, and ancillary requirements to support implementation of these restrictions.
As described in Unit IV.A., the 1-BP WCPP would be non-prescriptive, in the sense that regulated entities would not be required to use specific controls prescribed by EPA to achieve the exposure concentration limit. Rather, it would be a performance-based exposure limit that would enable owners or operators to determine how to most effectively meet the exposure limit based on conditions at their workplace.
A central component of the 1-BP WCPP is the exposure limit. Exposures remaining at or below the ECEL would address any unreasonable risk of injury to health contributed by inhalation exposures for occupational conditions of use. EPA's proposed requirements include the specific exposure limits that would be required to meet the TSCA section 6(a) standard to apply one or more requirements to the substance so that it no longer presents unreasonable risk, and also include ancillary requirements necessary for the ECEL's
Regarding recordkeeping requirements, three primary provisions of the proposed rule relate to recordkeeping. The first is recordkeeping of general records: all persons who manufacture, process, distribute in commerce, or engage in industrial or commercial use of 1-BP or products containing 1-BP, except for the use of 1-BP in insulation, must maintain ordinary business records, such as invoices and bills-of-lading related to compliance with the prohibitions, restrictions, and other provisions of the regulation.
The second is recordkeeping related to WCPP compliance: under the proposed regulatory action, facilities complying with the rule through WCPP would be required to develop and maintain records associated with ECEL exposure monitoring (including measurements, compliance with Good Laboratory Practice Standards, and information regarding monitoring equipment); ECEL compliance (including the exposure control plan, PPE program implementation, and workplace information and training); and workplace participation. To support and demonstrate compliance, EPA is proposing that each owner or operator of a workplace subject to the WCPP retain compliance records for five years.
EPA is also proposing to require self-certification for certain occupational conditions of use. To further support and demonstrate compliance, EPA is proposing to require owners or operators to self-certify with a self-certification statement and provide that statement to distributors of 1-BP, as described in Unit IV.A. EPA is also proposing that each owner or operator of a facility subject to self-certification, and distributors of 1-BP to such facilities, retain compliance records for five years.
The small entities that would be potentially directly regulated by this rulemaking are small entities that manufacture (including import), process, distribute in commerce, use, or dispose of 1-BP, including retailers of 1-BP for end-consumer uses.
Entities that would be subject to this proposal that manufacture (including import), process, or distribute 1-BP in commerce for consumer use (except for the use of 1-BP in insulation) would be required to cease under the proposed rule. The entity would be required to modify their SDS to inform their customers of the prohibition on manufacture, processing, and distribution of 1-BP for consumer use (except for the consumer use of 1-BP in building/construction materials (insulation)). They would also be required to maintain ordinary business records, such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation. These are all routine business tasks that do not require specialized skills or training.
Entities that use 1-BP in any industrial and commercial capacity that is proposed to be prohibited would be required to cease under the proposed rule. Restriction or prohibition of these uses will likely require the implementation of an alternative chemical or the cessation of use of 1-BP in a process or equipment that may require persons with specialized skills, such as engineers or other technical experts. Instead of developing an alternative method themselves, industrial and commercial users of 1-BP may choose to contract with another entity to do so.
Certain entities that would be permitted to continue to manufacture, process, distribute, use, or dispose of 1-BP would be required to implement a WCPP and would have to meet the provisions of the program for continued use of 1-BP. A transition to a WCPP may require persons with specialized skills such as an engineer or health and safety profession. Instead of implementing the WCPP themselves, entities that use 1-BP may choose to contract with another entity to do so. Records would have to be maintained for compliance with a WCPP, as applicable. While this recording activity itself may not require a special skill, the information to be measured and recorded may require persons with specialized skills, such as an industrial hygienist.
Certain entities that would be permitted to continue to manufacture, process, distribute, use, or dispose of 1-BP would be required to self-certify and would have to meet the provisions of self-certification for continued purchase of 1-BP. Records would have to be maintained for compliance with self-certification, as applicable. While this recording activity itself may not require a special skill, the information to be measured and recorded may require persons with specialized skills, such as an industrial hygienist, engineers, or other technical experts.
EPA has issued numerous rules and notices pertaining to 1-BP under its various authorities. 1-BP manufacturing (including importing), processing, and use information is reported under the Chemical Data Reporting (CDR) rule (85 FR 20122, April 9, 2020; see 40 CFR part 711). 1-BP is also a listed substance subject to Toxics Release Inventory (TRI) reporting requirements pursuant to section 313 of the Emergency Planning and Community Right-To-Know Act (EPCRA), effective as of January 1, 2016 (40 CFR 372.65).
Relative to releases to air, in 2010 and 2011, EPA received petitions from the Halogenated Solvents Industry Alliance and the New York State Department of Environmental Conservation to list 1-BP as a hazardous air pollutant (HAP) under Section 112(b)(1) of the Clean Air Act (80 FR 6676, February 6, 2015). On January 9, 2017, EPA published a draft notice on the rationale for granting the petitions to add 1-BP to the list of HAPs (82 FR 2354, January 9, 2017), and subsequently issued a final notice granting the petitions to add 1-BP to the list of HAPs contained in Section 112(b)(1) of the CAA, 42 U.S.C. 7412 (85 FR 36851, June 18, 2020). On January 5, 2022, EPA published a final rule adding 1-BP to the list of HAPs (87 FR 393), effective February 4, 2022. In addition, 1-BP is listed under the National Volatile Organic Compound (VOC) Emission Standards for Aerosol Coatings (40 CFR part 59, subpart E).
The listing of 1-BP as a HAP also triggered the addition of 1-BP as a hazardous substance under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (87 FR 20721, April 8, 2022), so that releases of 1-BP in excess of one pound must be reported (40 CFR 302).
Under EPA's Significant New Alternatives Policy (SNAP) program, EPA evaluated 1-BP as an acceptable substitute for ozone-depleting substances. In 2007, EPA listed 1-BP as an acceptable substitute for chlorofluorocarbon (CFC)-113 and methyl chloroform in the solvent and cleaning sector of industrial equipment for metals cleaning, electronics cleaning, and precision cleaning. EPA recommended the use of personal protective equipment, including chemical goggles, flexible laminate protective gloves and chemical-resistant clothing when using 1-BP (72 FR 30142, May 30, 2007). In 2007, the Agency also proposed to list 1-BP as an unacceptable substitute for CFC-113, hydrochlorofluorocarbon (HCFC)-141b
While OSHA has not issued a PEL for 1-BP, OSHA and NIOSH have issued a Hazard Alert, which indicates a recommended time-weighted average threshold limit value (TWA-TLV) of 10 ppm by the American Conference of Governmental Industrial Hygienists (Ref. 10). However, since then, ACGIH has recommended 0.10 ppm as the TWA-TLV value for 1-BP (Ref. 10). The U.S. Department of Transportation (DOT) regulates specific bromopropanes as a hazardous material,
EPA analyzed alternative regulatory approaches to identify which would be feasible, reduce burden to small businesses, and achieve the objective of the statute (
This action does not contain an unfunded mandate of $100 million (adjusted annually for inflation) or more (in 1995 dollars) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action would affect entities that use 1-BP. It is not expected to affect state, local, or Tribal governments because the use of 1-BP by government entities is minimal. The costs involved in this action are estimated not to exceed $183 million in 2023$ ($100 million in 1995$ adjusted for inflation using the GDP implicit price deflator) or more in any one year.
EPA has concluded that this action has federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because regulations under TSCA section 6(a) may preempt State law. As set forth in TSCA section 18(a)(1)(B), the issuance of rules under TSCA section 6(a) to address the unreasonable risks presented by a chemical substance has the potential to trigger preemption of laws, criminal penalties, or administrative actions by a State or political subdivision of a State that are: (1) Applicable to the same chemical substance as the rule under TSCA section 6(a); and (2) Designed to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of that same chemical. TSCA section 18(c)(3) applies that preemption only to the “hazards, exposures, risks, and uses or conditions of use” of such chemical included in the final TSCA section 6(a) rule.
EPA provides the following preliminary federalism summary impact statement. The Agency consulted with State and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development. This included background presentation on September 9, 2020, and a consultation meeting on October 22, 2020. EPA invited the following national organizations representing State and local elected officials to these meetings: Association of State Drinking Water Administrators, National Association of Clean Water Agencies, Western States Water Council, National Water Resources Association, American Water Works Association, Association of Metropolitan Water Agencies, Association of Clean Water Administrators, Environmental Council of the States, National Association of Counties, National League of Cities, County Executives of America, U.S. Conference of Mayors, and National Association of Attorneys General. A summary of the meeting with these organizations, including the views that they expressed, is available in the docket (Ref. 20). EPA provided an opportunity for these organizations to provide follow-up comments in writing but did not receive any such comments.
This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. This rulemaking would not have substantial direct effects on Tribal governments because 1-BP is not manufactured, processed, or distributed in commerce by Tribes. 1-BP is not regulated by Tribes, and this rulemaking would not impose substantial direct compliance costs on Tribal governments. Thus, Executive Order 13175 does not apply to this action. Nevertheless, EPA met with Tribal officials during the development of this action consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, which EPA applies more broadly than Executive Order 13175.
As described in Unit III.A.1., EPA met with Tribal officials via teleconferences on November 12, 2020, and November 17, 2020, concerning the prospective regulation of the 1-BP under TSCA
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. While the environmental health or safety risks addressed by this action present a disproportionate risk to children because the most sensitive adverse health effects are in early life stages, this action is not subject to Executive Order 13045 because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866.
However, EPA's
This action is not a “significant energy action” under Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.
Pursuant to the NTTAA section 12(d), 15 U.S.C. 272, the Agency has determined that this rulemaking involves environmental monitoring or measurement, specifically for occupational inhalation exposures to 1-BP. Consistent with the Agency's Performance Based Measurement System (PBMS), the Agency proposes not to require the use of specific, prescribed analytic methods. Rather, the Agency plans to allow the use of any method that meets the prescribed performance criteria. The PBMS approach is intended to be more flexible and cost-effective for the regulated community; it is also intended to encourage innovation in analytical technology and improved data quality. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified.
For this rulemaking, the key consideration for the PBMS approach is the ability to accurately detect and measure airborne concentrations of 1-BP at the ECEL and the ECEL action level. Some examples of methods which meet the criteria are included in appendix B of the ECEL memo (Ref. 12). EPA recognizes that there may be voluntary consensus standards that meet the proposed criteria (Ref. 41). EPA requests comments on whether it should incorporate such voluntary consensus standards in the final rule and seeks information in support of such comments regarding the availability and applicability of voluntary consensus standards that may achieve the sampling and analytical requirements of the proposed rule in lieu of the PBMS approach.
EPA believes that the human health and environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns. As described more fully in the Economic Analysis, EPA conducted an analysis to characterize the baseline conditions faced by communities and workers affected by the regulation to identify the potential for disproportionate impacts on communities with environmental justice concerns. The baseline characterization suggests that workers in affected industries and regions, as well as residents of nearby communities, are more likely to be people of color than the general population in affected states, although this varied by use assessed.
EPA believes that this action is likely to reduce existing disproportionate and adverse effects on communities with environmental justice concerns. While the regulatory options are anticipated to address the unreasonable risk from exposure to 1-BP to the extent necessary so that it is no longer unreasonable, EPA is not able to quantify the distribution of the change in risk across affected workers, communities, or demographic groups. EPA is also unable to quantify the changes in risks to workers, communities, and demographic groups from non-1-BP-using technologies or practices that firms may adopt in response to the regulation to determine whether any such changes could pose EJ concerns. Data limitations prevent EPA from conducting a more comprehensive analysis that would identify the incremental impacts of the regulatory options and assess the extent to which they mitigate or exacerbate any disproportionate impacts in communities with EJ concerns. These data limitations are summarized in the Economic Analysis (Ref. 3).
EPA additionally identified and addressed EJ concerns by conducting outreach to advocates of communities that might be subject to disproportionate exposure to 1-BP, such as communities with environmental justice concerns. On November 16 and 19, 2020, EPA held public meetings as part of this consultation. (Ref. 22). See also Unit III.A.1.
The information supporting the review under Executive Order 12898 and Executive Order 14096 is contained in Units I.E., II.D., III.A.1., VI.A., and in the Economic Analysis (Ref. 3). EPA's presentations and fact sheets for the EJ consultations related to this rulemaking, are available at
Environmental protection, Chemicals, Export notification, Hazardous substances, Import certification, Reporting and recordkeeping.
Therefore, for the reasons stated in the preamble, EPA proposes to amend 40 CFR part 751 as follows:
15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
This subpart establishes prohibitions and restrictions on the manufacture (including import), processing, distribution in commerce, use, and disposal of 1-bromopropane (CASRN 106-94-5), also known as n-propyl bromide, to prevent unreasonable risks of injury to health in accordance with TSCA section 6(a).
The definitions in subpart A of this part apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply to this subpart:
(a)
(1) All manufacturing, processing, and distribution in commerce for consumer use, excluding use of 1-bromopropane in building/construction materials (insulation).
(2) All manufacturing (including import), processing, and distribution in commerce of 1-bromopropane for industrial or commercial use, other than for the conditions of use addressed under §§ 751.807(a) and 751.809(a) of this subpart.
(3) All commercial or industrial use of 1-bromopropane, other than the conditions of use addressed under §§ 751.807(a) and 751.809(a) of this subpart.
(b)
(1) After [DATE 6 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(2) After [DATE 9 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(3) After [DATE 12 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(4) After [DATE 15 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(5) After [DATE 15 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(6) After [DATE 18 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(a)
(1) Manufacturing (domestic manufacturing);
(2) Processing into formulation, mixture or reaction products;
(3) Industrial and commercial use as solvent for open-top and in-line batch vapor degreasing;
(4) Industrial and commercial use as solvent for closed-loop batch vapor degreasing;
(5) Industrial and commercial use as solvent for cleaning and degreasing in cold cleaners;
(6) Industrial and commercial use as solvent in aerosol spray degreaser/cleaner; and
(7) Industrial and commercial uses in other uses, in electronic and electronic products and metal products; asphalt extraction; laboratory chemicals; temperature indicator—coatings
(b)
(1)
(2)
(i)
(A) Owners or operators must determine each potentially exposed person's exposure by either:
(
(
(B) Personal breathing zone air samples are representative of the 8-hour TWA of all potentially exposed persons in an exposure group if the samples are of at least one person's full-shift exposure who represents the highest potential 1-bromopropane exposures in that exposure group.
(C) Exposure samples must be analyzed using an appropriate analytical method by a laboratory that complies with the Good Laboratory Practice Standards in 40 CFR part 792 or a laboratory accredited by the American Industrial Hygiene Association (AIHA) or another industry-recognized program.
(D) Owners or operators must ensure that methods used to perform exposure monitoring produce results that are accurate, to a confidence level of 95 percent, to within plus or minus 25 percent for airborne concentrations of 1-bromopropane.
(E) Owners and operators must re-monitor within 15 working days after receipt of any exposure monitoring when results indicate non-detect or air monitoring equipment malfunction, unless an Environmental Professional as defined at 40 CFR 312.10 or a Certified Industrial Hygienist reviews the monitoring results and determines re-monitoring is not necessary.
(ii)
(iii)
(iv)
(A) The owner or operator must conduct the exposure monitoring required by paragraph (b)(2)(ii) of this section within 30 days after there has been a change in the production, process, control equipment, personnel or work practices that may reasonably be expected to result in new or additional exposures above the ECEL action level or when the owner or operator has any reason to believe that new or additional exposures above the ECEL action level have occurred.
(B) Whenever start-ups or shutdowns, or spills, leaks, ruptures or other breakdowns or unexpected releases occur that may lead to exposure to potentially exposed persons, the owner or operator must conduct the exposure monitoring required by paragraph (b)(2)(ii) of this section within 30 days after the conclusion of the start-up or shutdown and/or the cleanup of the spill or repair of the leak, rupture or other breakdown.
(v)
(A) The owner or operator must provide potentially exposed persons an opportunity to observe any monitoring of occupational exposure to 1-BP that is conducted under this section and is designed to characterize the potentially exposed person's exposure.
(B) When monitoring observation requires entry into a regulated area, the owner or operator must provide the observers with the required PPE in accordance with paragraph (b)(3)(iv).
(vi)
(A) The owner or operator must inform each person whose exposures are monitored or who is part of a monitored exposure group of any represented by the monitoring of the monitoring results within 15 working days of receipt of monitoring results.
(B) This notification must include the following:
(
(
(
(
(
(
(
(
(
(C) Notice must be written, in plain language, and either provided to each potentially exposed person individually in a language that the person understands, or posted in an appropriate and accessible location outside the regulated area with an English-language version and a non-English language version representing the language of the largest group of workers who do not read English.
(3)
(i)
(ii)
(iii)
(iv)
(A) The owner or operator must ensure that each person who enters a regulated area is supplied with a respirator selected in accordance with paragraph (e) of this section and must ensure that all persons within the regulated area are using the provided respirators whenever 1-bromopropane exposures may exceed the ECEL.
(B) An owner or operator who has implemented all feasible controls as required in paragraph (c)(1) of this section, and who has established a regulated area as required by paragraphs (b)(3)(i) and (iii) of this section where 1-bromopropane exposure can be reliably predicted to exceed the ECEL only on certain days (for example, because of work or process schedule) must have persons use respirators in that regulated area on those days.
(vi) The owner or operator must ensure that, within a regulated area, persons do not engage in non-work activities which may increase 1-bromopropane exposure.
(vii) The owner or operator must ensure that while persons are wearing respirators in the regulated area, they do not engage in activities which interfere with respirator seal or performance.
(c)
(1)
(i) By [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(ii) If the feasible controls required under paragraph (c)(1)(i) of this section that can be instituted do not reduce exposures for potentially exposed persons to or below the ECEL, then the owner or operator must use such controls to reduce exposure to the lowest levels achievable by these controls and must supplement those controls with the use of respiratory protection that complies with the requirements of paragraph (e) of this section.
(iii) Where an owner or operator cannot demonstrate that exposure to 1-bromopropane has been reduced to or below the ECEL through the use of controls required under paragraphs (c)(1)(i) and (ii) of this section, and has not demonstrated that it has appropriately supplemented with respiratory protection that complies with the requirements of paragraph (e) of this section, this will constitute a failure to comply with the ECEL.
(iv) For the Department of Defense and Federal contractors acting for or on behalf of the Department of Defense, in the event that ongoing or planned construction is necessary to implement the feasible controls required by paragraph (c)(1)(i) of this section such that no one is exposed above the ECEL, the deadlines in paragraph (c)(1)(i) of this section are extended to [DATE 60 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(2)
(i)
(A) Identification of exposure controls that were considered, including those that were used or not used to meet the requirements of paragraph (c)(1)(i) of this section, in the following sequence: elimination, substitution, engineering controls and administrative controls;
(B) For each exposure control considered, a rationale for why the exposure control was selected or not selected based on feasibility, effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to implement exposure controls selected, including proper installation, regular inspections, maintenance, training or other actions;
(D) A description of regulated areas, how they are demarcated, and persons authorized to enter the regulated areas;
(E) Description of activities conducted by the owner or operator to review and update the exposure control plan in compliance with paragraph (c)(2)(ii)(C) of this section to ensure effectiveness of the exposure controls, identify any necessary updates to the exposure controls, and confirm that all persons are properly implementing the exposure controls;
(F) Attestation that exposure controls selected do not increase emissions of 1-bromopropane to ambient air outside of the workplace and whether additional equipment was installed to capture or
(ii)
(A) The owner or operator must not implement a schedule of personnel rotation as a means of compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any controls instituted under this paragraph (c).
(C) The exposure control plan must be reviewed and updated as necessary, but at least every 5 years, to reflect any significant changes in the status of the owner or operator's approach to compliance with paragraphs (b) and (c) of this section.
(iii)
(A) Owners or operators must make the exposure control plan and associated records available to potentially exposed persons.
(B) Owners or operators must notify potentially exposed persons of the availability of the exposure control plan and associated records within 30 days of the date that the exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and associated records must be provided in plain language writing to each potentially exposed person in a language that the person understands or posted in an appropriate and accessible location outside the regulated area with an English-language version and a non-English language version representing the language of the largest group of workers who do not read English.
(d)
(1) By [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(2) The owner or operator must ensure that each potentially exposed person is trained prior to or at the time of a potential exposure to 1-bromopropane.
(3) The owner or operator must ensure that information and training is presented in a manner that is understandable to each person required to be trained.
(4) The following information and training must be provided to all persons potentially exposed to 1-bromopropane:
(i) The requirements of this section, as well as how to access or obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of 1-bromopropane and the specific operations in the workplace that could result in exposure to 1-bromopropane, particularly noting where each regulated area is located;
(iii) Methods and observations that may be used to detect the presence or release of 1-bromopropane in the workplace (such as monitoring conducted by the owner or operator, continuous monitoring devices, visual appearance or odor of 1-bromopropane when being released);
(iv) The acute and chronic health hazards of 1-BP as detailed on relevant Safety Data Sheets; and
(v) The principles of safe use and handling of 1-bromopropane and measures potentially exposed persons can take to protect themselves from 1-bromopropane, including specific procedures the owner or operator has implemented to protect potentially exposed persons from exposure to 1-bromopropane, such as appropriate work practices, emergency procedures, and personal protective equipment to be used.
(5) The owner or operator must re-train each potentially exposed person annually to ensure that each such person maintains the requisite understanding of the principles of safe use and handling of 1-bromopropane in the workplace.
(6) Whenever there are workplace changes, such as modifications of tasks or procedures or the institution of new tasks or procedures, that increase exposure, and where such exposure exceeds or can reasonably be expected to exceed the ECEL action level, the owner or operator must update the training and ensure that each potentially exposed person is re-trained.
(e)
(1)
(i) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(ii) For the purposes of this paragraph (e)(1), cross-referenced provisions in 29 CFR 1910.134 applying to an “employee” apply equally to potentially exposed persons and cross-referenced provisions applying to an “employer” also apply equally to owners or operators. Other terms in cross-referenced provisions in 29 CFR 1910.134 that are defined in 29 CFR 1910.134(b) have the meaning assigned to them in that paragraph.
(iii) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(iv) Owners and operators must select respiratory protection required by paragraph (e)(1)(i) based on a medical evaluation consistent with the requirements of 29 CFR 1910.134(e), 1910.134 App. C. If a potentially exposed person cannot use a negative-pressure respirator that would otherwise be required by paragraph (e)(1)(i), then the owner or operator must provide that person with an alternative respirator. The alternative respirator must have less breathing resistance than the negative-pressure respirator and provide equivalent or greater protection. If the person is unable to use an alternative respirator, then the person must not be permitted to enter the regulated area.
(v) Owners and operators must select respiratory protection that properly fits each affected person and communicate
(vi) Owners and operators must provide, ensure use of, and maintain (in a sanitary, reliable, and undamaged condition) respiratory protection that is of safe design and construction for the applicable condition of use consistent with the requirements of 29 CFR 1910.134(g) through (j), 1910.134 App. B-1 to B-2.
(vii) Prior to or at the time of initial assignment to a job involving potential exposure to 1-bromopropane, owners and operators must provide training to all persons required to use respiratory protection consistent with 29 CFR 1910.134(k), 1910.134 App. D.
(viii) Owners and operators must retrain all persons required to use PPE at least annually, or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use PPE, or when changes in the workplace or in PPE to be used render the previous training obsolete.
(ix) Owners or operators must select and provide to persons appropriate respirators as indicated by the most recent monitoring results as follows:
(A) If the measured exposure concentration is at or below 0.05 ppm: no respiratory protection is required.
(B) If the measured exposure concentration is above 0.05 ppm and less than or equal to 0.5 ppm (10 times ECEL): Any NIOSH Approved® air-purifying half mask respirator equipped with organic vapor cartridges or canisters; or any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator operated in demand mode equipped with a half mask; or any NIOSH-certified Self-Contained Breathing Apparatus (SCBA) in demand mode equipped with a half mask [APF 10].
(C) If the measured exposure concentration is above 0.5 ppm and less than or equal to 1.25 ppm (25 times ECEL): Any NIOSH Approved® Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting facepiece or hood/helmet equipped with organic vapor cartridges or canisters; or any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-flow mode equipped with a loose-fitting facepiece or helmet/hood [APF 25].
(D) If the measured exposure concentration is above 1.25 ppm and less than or equal to 2.5 ppm (50 times ECEL): Any NIOSH Approved® air-purifying full facepiece respirator equipped with organic vapor cartridges or canisters; any NIOSH Approved® Powered Air-Purifying Respirator (PAPR) with a half mask equipped with organic vapor cartridges or canisters; any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator in a pressure-demand or other positive pressure mode with a half mask; any NIOSH Approved®s Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-flow mode equipped with a half mask; any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator in a pressure-demand or other positive pressure mode with a half mask; or any NIOSH Approved® SCBA in demand-mode equipped with a full facepiece or helmet/hood [APF 50].
(E) If the measured exposure concentration is above 2.5 ppm and less than or equal to 50 ppm (1,000 times ECEL): Any NIOSH Approved® Powered Air-Purifying Respirator (PAPR) equipped with a full facepiece equipped with organic vapor cartridges or canisters; any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-flow mode equipped with full facepiece; any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator in pressure-demand or other positive-pressure mode equipped with a full facepiece and an auxiliary self-contained air supply [APF 1,000]; or any NIOSH Approved® Supplied-Air Respirator (SAR) or Airline Respirator in a continuous-flow mode equipped with a helmet or hood and has been tested to demonstrate performance at a level of a protection of APF 1,000 or greater.
(F) If the measured exposure concentration is greater than 50 ppm (1,000 times ECEL): Any NIOSH Approved® Self-Contained Breathing Apparatus (SCBA) in a pressure-demand or other positive-pressure mode equipped with a full facepiece or helmet/hood [APF 10,000].
(G) If the exposure concentration is unknown: Any NIOSH Approved® Self-Contained Breathing Apparatus (SCBA) in a pressure-demand or other positive-pressure mode equipped with a full facepiece or helmet/hood [APF 10,000].
(x) Owners and operators must select and provide respirators as required in paragraph (e)(1)(ix) of this section consistent with the requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of workplace and user factors that affect respirator performance and reliability.
(xi) Owners and operators who select air-purifying respirators must either:
(A) Select respirators that have an end-of-service-life indicator (ESLI) that is NIOSH-certified for 1-bromopropane; or
(B) Implement a change schedule for canisters and cartridges based on objective information or data that ensures that canisters and cartridges are changed before the end of their service life. The written respiratory protection program required by paragraph (e)(1)(iii) of this section must include a description of the information and data relied upon, the basis for reliance on the information and data, and the basis for the canister and cartridge change schedule.
(xii) Owners and operators must ensure that respirators are used in compliance with the terms of the respirator's NIOSH certification.
(xiii) Owners and operators must conduct regular evaluations of the workplace, including consultations with potentially exposed persons using respiratory protection, consistent with the requirements of 29 CFR 1910.134(l), to ensure that the provisions of the written respiratory protection program required under paragraph (e)(1)(iii) of this section are being effectively implemented.
(xiv) The respiratory protection requirements in this paragraph represent the minimum respiratory protection requirements, such that any respirator affording a higher degree of protection than the required respirator may be used.
(2)
(i) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(ii) The owner or operator must provide training and retraining to all persons required to use gloves consistent with § 751.809(b)(4) and (5).
(a)
The provisions of this section apply to workplaces engaged in the following conditions of use of 1-bromopropane, unless otherwise indicated:
(1) Manufacturing (import);
(2) Processing as a reactant;
(3) Processing for incorporation into articles;
(4) Processing as repackaging;
(5) Processing as recycling; and
(6) Disposal.
(b)
(1) Beginning [DATE 36 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(2) Owners and operators must select gloves that properly fit each affected person and communicate glove selections to each affected person.
(3) Owners and operators must provide, ensure use of, and maintain (in a sanitary, reliable, and undamaged condition) gloves that are of safe design and construction for the work to be performed.
(4) Owners or operators must provide training in accordance with 29 CFR 1910.132(f) to all persons required to use gloves prior to or at the time of initial assignment to a job involving exposure to 1-bromopropane. For the purposes of this paragraph (b), provisions in 29 CFR 1910.132(f) applying to an “employee” also apply equally to potentially exposed persons, and provisions applying to an “employer” also apply equally to owners or operators.
(5) Owners and operators must retrain each person required to use gloves at least annually or whenever the owner or operator has reason to believe that a previously trained person does not have the required understanding and skill to properly use gloves, or when changes in the workplace or in gloves to be used render the previous training obsolete.
(a)
The provisions of this section apply to the following conditions of use of 1-bromopropane, unless otherwise indicated:
(1) Processing into a formulation, mixture, or reaction product;
(2) Industrial and commercial use as a solvent in open-top and in-line batch vapor degreasing;
(3) Industrial and commercial use as a solvent in closed-loop vapor degreasing;
(4) Industrial and commercial use as a solvent for cleaning and degreasing in cold cleaners;
(5) Industrial and commercial use as a solvent in aerosol spray degreaser/cleaner; and
(6) Industrial and commercial use in other uses in electronic and electronic products and metal products; laboratory chemicals; asphalt extraction; and coatings for temperature indicators.
(b)
(1) The owner or operator purchasing 1-bromopropane for one or more of the conditions of use listed in (a) must comply with the requirements of § 751.807.
(2) The owner or operator, or authorized person, must self-certify each facility engaging in one or more uses listed in paragraph (a) of this section are in compliance with requirements of § 751.807 of this subpart with the following written statement:
I certify each of the following statements, under penalty of law., This document was prepared under my direction and supervision. I further certify that this facility's implementation of the Workplace Chemical Protection Program (WCPP) for 1-bromopropane was evaluated by qualified personnel with industrial hygiene qualifications or similar experience and that this facility has implemented and complies with the WCPP for 1-bromopropane. Based on my inquiry of the individual or individuals who manage the facility and/or those individuals directly responsible for implementing the 1-bromopropane WCPP, and to the best of my knowledge and belief, the facility is in compliance with the 1-bromopropane WCPP, including the exposure control plan. I am aware that there are significant penalties, including the possibility of civil penalties for failing to comply with these requirements and criminal fines and imprisonment, for knowingly failing to comply with these requirements. If this is the first purchase of 1-bromopropane for this facility, I understand that this certification will serve as a certification that this facility will properly implement and comply with the WCPP for 1-bromopropane consistent with the applicable regulatory timelines.
(i) The statement must include the following:
(A) Printed name and signature, job classification, title, email address and phone number of the owner or operator, or authorized person, who is self-certifying;
(B) Date of self-certification;
(C) Name and address of the facility;
(D) Lists the condition of use, (
(E) Examples of the type of equipment the owner or operator plans to use to meet the WCPP (
(F) Indication of whether this is the facility's first purchase of 1-bromopropane after [DATE OF PUBLICATION OF THE FINAL RULE IN THE
(ii) Owners and operators must provide a current self-certification statement for each facility to the distributor from whom 1-bromopropane is being purchased for every purchase.
(iii) The self-certification statement is valid for one year, unless the facility has changed processes or there is an indication that exposures to 1-BP have changed.
(iv) Distributors of 1-bromopropane must review the self-certification statement to ensure it is appropriately completed to include the owner or operator's and the facility's information, as required by this section.
(v) Distributors of 1-bromopropane must have a complete and valid self-certification statement in accordance with this section for each sale of 1-bromopropane for a use described in paragraph (a) of this section. If the distributor obtains knowledge that the purchaser of 1-BP has failed to comply with the WCPP for 1-BP, the distributor must immediately cease to supply the substance to that purchaser, and may only commence supplying to the purchaser upon, unless the distributor has received written notification from EPA that permits its distribution.
(a) Beginning on [DATE 2 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(b) Beginning on [DATE 6 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(c) The notification required under paragraphs (a) and (b) of this section must occur by inserting the following text in sections 1(c) and 15 of the Safety Data Sheet (SDS) provided with the 1-bromopropane or with any product
After [DATE 18 MONTHS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(a)
After [DATE 60 DAYS AFTER THE DATE OF PUBLICATION OF THE FINAL RULE IN THE
(b)
(1)
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of 1-bromopropane in use at the time of each monitoring event;
(iii) All measurements that may be necessary to determine the conditions that may have affected the monitoring results;
(iv) Name, workplace address, work shift, job classification, work area, and type of respiratory protection (if any) of each monitored person;
(v) Identification of all potentially exposed persons that a monitored person is intended to represent if using a representative sample, consistent with § 751.807(b)(2)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in § 751.807(b)(2)(i)(D);
(vii) Compliance with the Good Laboratory Practice Standards in 40 CFR part 792, or use of a laboratory accredited by the AIHA or another industry-recognized program, as required by § 751.807(b)(2)(i)(C);
(viii) Information regarding air monitoring equipment, including: type, maintenance, calibrations, performance tests, limits of detection, and any malfunctions; and
(xi) Notification of exposure monitoring results in accordance with § 751.801(b)(2)(v).
(2)
(i) Exposure control plan as described in § 751.807(c)(2);
(ii) Implementation of the exposure control plan described in § 751.807(c)(2), including:
(A) Any regular inspections, evaluations, and updating of the exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure controls; and
(C) Each occurrence and duration of any start-up, shutdown, or malfunction of the facility that causes an exceedance of the ECEL and any subsequent corrective actions taken by the owner or operator during the start-up, shutdown, or malfunctions to mitigate exposures to 1-bromopropane.
(iii) Respiratory protection used by each potentially exposed person and PPE program implementation as described in § 751.807(e), including:
(A) The name, workplace address, work shift, job classification, and work area of each potentially exposed person, and the type of respiratory protection provided to each potentially exposed person;
(B) The basis for the specific PPE selection in accordance with § 751.807(e); and
(C) Fit testing and training in accordance with § 751.807(e).
(iv) Information and training provided as required in § 751.807(d).
(3)
(c)
Owners and operators subject to the dermal protection requirements described in § 751.807(e)(2) or § 751.809 of this subpart must maintain records of the following information:
(1) Dermal protection used by each potentially exposed person and PPE program implementation as described in § 751.809(b), including the name, workplace address, work shift, job classification, and work area of each person reasonably likely to directly handle 1-bromopropane or handle equipment or materials on which 1-bromopropane may present;
(2) Appropriately sized gloves and the type of glove being used at the facility, either supported polyvinyl alcohol, multiple-layer laminates, or other gloves as provided under subsequent guidance of this rule; and
(3) Training in accordance with § 751.809(b)(4) and (5).
(d)
(1) Owners and operators who self-certify as required under § 751.811 must document and retain records of each self-certification statement for each facility that is self-certifying, including:
(i) Printed name and signature, job classification, email address and phone number of the owner or operator who is self-certifying;
(ii) Date of self-certification;
(iii) Name and address of the facility; and
(iv) All records required under paragraphs (a) and (b) of this section.
(2) Distributors of 1-bromopropane must collect, maintain, and retain records relating to self-certification statements received under § 751.811 that include the following:
(i) Name of facility;
(ii) Name of owner or operator who is self-certifying;
(iii) Date of sale;
(iv) Quantity of 1-bromopropane being purchased; and
(v) Self-certification statement for each purchase of 1-bromopropane.
(e)
Persons required to maintain records required under this section must maintain the records for a period of 5 years from the date that such records were generated.
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose to list the Cedar Key mole skink (
We will accept comments received or postmarked on or before October 7, 2024. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Lourdes Mena, Division Manager, Classification and Recovery, Florida Ecological Services Field Office, 7915 Baymeadows Way, Suite 200, Jacksonville, FL 32256-7517;
Section 4(a)(3) of the Act requires the Secretary of the Interior (Secretary), to the maximum extent prudent and determinable, concurrently with listing designate critical habitat for the species. Section 3(5)(A) of the Act defines critical habitat as (i) the specific areas within the geographical area occupied by the species, at the time it is listed, on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protections; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination by the Secretary that such areas are essential for the conservation of the species. Section 4(b)(2) of the Act states that the Secretary must make the designation on the basis of the best scientific data available and after taking into consideration the economic impact, the impact on national security, and any other relevant impacts of specifying any particular area as critical habitat.
We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:
(1) The subspecies' biology, range, and population trends, including:
(a) Biological or ecological requirements of the subspecies, including habitat requirements for feeding, breeding, and sheltering;
(b) Genetics and taxonomy;
(c) Historical and current range, including distribution patterns and the locations of any additional populations of this subspecies;
(d) Historical and current population levels, and current and projected trends; and
(e) Past and ongoing conservation measures for the subspecies, its habitat, or both.
(2) Threats and conservation actions affecting the subspecies, including:
(a) Factors that may be affecting the continued existence of the subspecies, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or humanmade factors;
(b) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this subspecies; and
(c) Existing regulations or conservation actions that may be addressing threats to this subspecies.
(3) Additional information concerning the historical and current status of this subspecies.
(4) Specific information on:
(a) The amount and distribution of Cedar Key mole skink habitat;
(b) Any additional areas occurring within the range of the subspecies, the Cedar Keys in Levy County, Florida, that should be included in the critical habitat designation because they (i) are occupied at the time of listing and contain the physical or biological feature that is essential to the conservation of the subspecies and that may require special management considerations or protection, or (ii) are unoccupied at the time of listing and are essential for the conservation of the subspecies;
(c) Special management considerations or protection that may be needed in the critical habitat areas we are proposing, including managing for the potential effects of climate change; and
(d) Whether areas not occupied at the time of listing qualify as habitat for the species and are essential for the conservation of the species.
(5) Land use designations and current or planned activities and their possible impacts on proposed critical habitat.
(6) Any probable economic, national security, or other relevant impacts of designating any area that may be included in the final designation, and the related benefits of including or excluding specific areas.
(7) Information on the extent to which the description of probable economic impacts in the economic analysis is a reasonable estimate of the likely economic impacts and any additional information regarding probable economic impacts that we should consider.
(8) Whether any specific areas we are proposing for critical habitat designation should be considered for exclusion under section 4(b)(2) of the Act, and whether the benefits of potentially excluding any specific area outweigh the benefits of including that area under section 4(b)(2) of the Act. If you think we should exclude any additional areas, please provide information supporting a benefit of exclusion.
(9) Whether we could improve or modify our approach to designating critical habitat in any way to provide for greater public participation and understanding, or to better accommodate public concerns and comments.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made solely on the basis of the best scientific and commercial data available, and section 4(b)(2) of the Act directs that the Secretary shall designate critical habitat on the basis of the best scientific data available.
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after the publication of this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), we may conclude that the subspecies is threatened instead of endangered, or we may conclude that the subspecies does not warrant listing as either an endangered species or a threatened species. For critical habitat, our final designation may not include all areas proposed, may include some additional areas that meet the definition of critical habitat, or may exclude some areas if we find the benefits of exclusion outweigh the benefits of inclusion and exclusion will not result in the extinction of the subspecies. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.
Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in
On July 11, 2012, we received a petition from the Center for Biological Diversity to list the Cedar Key mole skink as an endangered or threatened species under the Act. On July 1, 2015, we published in the
A species status assessment (SSA) team prepared an SSA report for the Cedar Key mole skink. The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the subspecies, including the impacts of past, present, and future factors (both negative and beneficial) affecting the subspecies.
In accordance with our joint policy on peer review published in the
As discussed in Peer Review above, we received comments from one peer reviewer on the draft SSA report. We reviewed the comments for substantive issues and new information regarding the contents of the SSA report. The peer reviewer generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions, including clarifications in terminology and other editorial suggestions.
The peer reviewer suggested that our statement that “rafting is rare, but does occur” was inappropriate. The peer reviewer noted that there is no evidence that rafting occurs in the Cedar Key mole skink (or any mole skink subspecies) and that, in fact, genetic evidence suggests the opposite (that there is no movement of mole skinks among islands). We updated the SSA report to indicate that rafting is unlikely.
The peer reviewer also commented that our analysis of “potential habitat” on the two developed islands, Way Key and Airstrip Island, was an overrepresentation of the amount of habitat truly available to the Cedar Key mole skink. In our initial analysis, we included high intensity and low intensity urban data layers for these islands as part of our calculation of potential habitat available because skinks have been found in backyards, in parking lots, along roadsides, and in other disturbed or developed areas. However, these data layers also included roads, buildings, and other developed areas, which are not considered habitat for the Cedar Key mole skink. As a result, our use of these data layers increased what we had identified as potential habitat on Airport Island from 1.00 acre (0.40 hectares) to 52.43 acres (21.0 hectares), and on Way Key from 2.65 acres (1.07 hectares) to 266.14 acres (107.70 hectares). We agree with the peer reviewer that the use of the urban areas in our analysis overestimated the amount of habitat truly available to the Cedar Key mole skink. Thus, we restricted our analysis of these two islands to only include the preferred habitat data layers that included beaches, dunes, and coastal hammock. We included the additional analysis focused on high-intensity and low-intensity urban areas on Way Key and Airport Island as part of appendix A in the SSA report.
A thorough review of the taxonomy, life history, and ecology of the Cedar Key mole skink (
The Cedar Key mole skink is semi-fossorial (adapted to digging, burrowing, and living underground) and cryptic in nature. The Cedar Key mole skink is a cold-blooded reptile and therefore highly dependent air and soil temperature to thermoregulate (maintain body core temperature) (Mount 1963, p. 362). Ground cover moderates soil temperatures and provides shade to assist in the skinks' thermoregulation in hot climate. The optimum temperature range for the mole skink species (
The specific diet of Cedar Key mole skink is unknown, but in general, skinks in the genus
The Cedar Keys are a coastal complex of islands, tidal creeks, bays, and salt marsh, located along 10 miles (16 kilometers) of Florida's central Gulf of Mexico coast in Levy County. The Cedar Key mole skink has been found in small numbers on 10 islands of the Cedar
The Cedar Keys archipelago is a relatively small coastal ecosystem of 30 or more, mostly undeveloped islands of varying size and elevations. Of the eight current islands with known Cedar Key mole skink occurrence, only one island, Airstrip Island, is developed. Deer Island, also occupied by the Cedar Key mole skink, is privately owned with one dwelling and could be further developed with a small number of (off-the-grid) dwellings. Way Key, the largest island within the Cedar Keys, where the City of Cedar Key is located, is mostly developed, but the Cedar Key mole skink population status there is uncertain. The remaining islands with known populations of the Cedar Key mole skink are undeveloped and largely protected as part of the Cedar Keys National Wildlife Refuge. There are other islands of the Cedar Keys archipelago that contain suitable habitat and soils for the Cedar Key mole skink, but they have unknown occupancy due to lack of survey efforts. Many of these islands are also protected as conservation lands, and some are privately owned (all or in part) but remain undeveloped.
Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. On April 5, 2024, jointly with the National Marine Fisheries Service, we issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and what criteria we apply when designating listed species' critical habitat (89 FR 24300). On the same day, we published a final rule revising our protections for endangered species and threatened species at 50 CFR 17 (89 FR 23919). These final rules are now in effect and are incorporated into the current regulations.
The Act defines a “species” as including any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature. The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:
(A) The present or threatened destruction, modification, or curtailment of its habitat or range;
(B) Overutilization for commercial, recreational, scientific, or educational purposes;
(C) Disease or predation;
(D) The inadequacy of existing regulatory mechanisms; or
(E) Other natural or manmade factors affecting its continued existence.
These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.
We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.
However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species.
The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis, which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at
The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be proposed for listing as an endangered or threatened species under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies.
To assess the Cedar Key mole skink's viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the subspecies to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years);
The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the subspecies' individual and population life-history needs. The next stage involved an assessment of the historical and current condition of the subspecies' demographics and habitat characteristics, including an explanation of how the subspecies arrived at its current condition. The final stage of the SSA involved making predictions about the subspecies' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of the subspecies to sustain populations in the wild over time, which we then used to inform our regulatory decision.
The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket No. FWS-R4-ES-2024-0053 on
In this discussion, we review the biological condition of the subspecies and its resources, and the threats that influence the subspecies' current and future condition, in order to assess the subspecies' overall viability and the risks to that viability.
The SSA report contains a detailed discussion of the Cedar Key mole skink's individual and population requirements (Service 2023, pp. 2-16); we provide a summary here. Based upon the best available scientific and commercial information, and acknowledging existing ecological uncertainties, the resource and demographic needs for breeding, feeding, sheltering, and dispersal of the Cedar Key mole skink are characterized as:
• Beaches, dunes, and coastal hammock habitats that provide ground cover in the form of leaf litter and wrack material, that the Cedar Key mole skink needs for nesting, arthropod and insect food sources, and cover; and
• Dry, loose, sandy, permeable, or friable (crumbly in texture) soils for digging of nest cavities and movement, as all portions of the Cedar Key mole skink's life cycle occur within or on the surface of the soil.
The Cedar Key mole skink's abundance, distribution, and life-history behaviors (
The main threats affecting the Cedar Key mole skink are related to shifts in climate as a result of increasing greenhouse gas emissions. Sea level rise, more frequent tidal flooding (increase of tides above the mean high tide), and increasing intensity of storm events (such as hurricanes) are the predominant threats to the Cedar Key mole skink and its habitat. We also evaluated existing regulatory mechanisms and ongoing conservation measures. In the SSA report, we considered additional threats: habitat loss and degradation that result from development and habitat disturbance; overutilization due to recreational, educational, and scientific use; disease; oil spills; and nonnative species. We concluded that, as indicated by the best available scientific and commercial information, these additional threats are currently having little to no impact on the Cedar Key mole skink, and thus their overall effect now and into the future is expected to be minimal. For full descriptions of all threats and how they impact the Cedar Key mole skink, please see the SSA report (Service 2023, pp. 16-31).
The predominant threats currently affecting the Cedar Key mole skink and its habitat are the rapid and intense shifts in climate occurring as a result of increasing greenhouse gas emissions. The entire Cedar Key archipelago is being affected by sea level rise, more frequent high tide flooding, and increased intensity of tropical storms and hurricanes. In the SSA report and this proposed rule, we discuss the effects of climate change on the Cedar Key mole skink in terms of increasing sea level rise, more frequent tidal flooding, and increased intensity of storm events.
The majority of the Cedar Keys are low-lying sandy islands (see table 1, below), making them highly susceptible to erosion and flooding, and at risk of inundation and saltwater intrusion (Florida Department of Environmental Protection (FDEP) 2012, p. 12; U.S. Geological Survey (USGS) 2017, unpaginated). As sea level rises, Cedar Key mole skink habitat becomes inundated and unusable due to saturation of the soils or direct loss of habitat. The Cedar Key mole skink utilizes coastal beach habitat and coastal maritime hammock habitat during all of its life stages, making it especially vulnerable to current and projected sea level rise across its entire range. The effects of rising sea levels (loss of beach habitat, coastal flooding, and saltwater intrusion) are currently being experienced along Florida's Gulf Coast, including the Cedar Keys, and these effects are projected to continue (see table 1, below; Carter et al. 2014, pp. 398-400, 403; Wadlow 2016, entire;
Information on direct impacts of hurricanes to the Cedar Key mole skink are lacking. However, there is information on impacts to habitat from recent hurricanes and other strong storms that have occurred in the region. Hurricane Hermine (Category 1) passed by the Cedar Keys in September 2016, causing widespread overwash and erosion to beach and coastal hammock habitats. Vegetation became buried, and the ground cover was greatly reduced from the resulting storm surge (Enge et al. 2017, entire). As a result of Hurricane Hermine, the beachfront of North Key lost most of the vegetative cover required for the Cedar Key mole skink (Enge et al. 2017, entire). In August 2023, Hurricane Idalia (Category 3) made landfall in the Cedar Keys and caused a storm surge of up to 7 feet (2.1 meters), causing complete overwash of many islands. For example, Seahorse Key lost 20 to 30 feet (6 to 9 meters) of beach and the remaining sand was left compacted (Thomas 2023, pers. comm.). Overtime, the vegetative cover will likely return to beach and coastal hammock habitats, but when these storm impacts occur repeatedly, there is less time for Cedar Key mole skink populations to recover from any single event (
The severity and duration of hurricane impacts to the Cedar Key mole skink and its habitat vary based on the intensity and scale of storm events. Localized impacts can vary greatly depending upon not only the strength of the storm but the direction of its approach and how quickly it moves through the area. Storm surges and their intensity can also vary depending on location. The increased intensity of storm events over the last several decades has likely led to a reduction in Cedar Key mole skink populations, thereby reducing overall population resiliency and the subspecies' redundancy.
In summary, impacts from climate change have the potential to reduce survival of the Cedar Key mole skink at the individual, population, and subspecies level. Sea level rise can degrade existing habitat that supports the Cedar Key mole skink, reducing the habitat features that the subspecies needs and thus reducing population resiliency. Increased high tide flooding and increased intensity of storm events have the potential to further degrade Cedar Key mole skink habitat. Increased high tide flooding and storm events also have the potential to kill skinks directly or to reduce individual survival, which could then lead to a reduction in population resiliency and the subspecies' redundancy. An increase in the intensity of storms or a direct hit from a strong hurricane could significantly reduce subspecies abundance (reducing population resiliency) and potentially extirpate populations (limiting redundancy). There are no regulatory mechanisms or conservation measures that address the impacts of sea level rise, high tide flooding, or increased intensity of storm events.
Several local, State, and Federal government plans provide conservation actions that directly or indirectly benefit the Cedar Key mole skink and its habitat. Levy County has several plans for coastal management, emergency management, and land use management, including their Comprehensive Plan (Frank et al. 2014, entire; Levy County 2017, entire). Levy County has policies to limit incompatible future growth and development in coastal areas subject to flooding (Frank et al. 2014, p. 69), which are areas where the Cedar Key mole skink's habitat occurs. The Comprehensive Plan also contains coastal setback guidelines, standards for construction near or on the shoreline, and policies for protecting environmentally sensitive land (Frank et al. 2014, p. 69; Levy County 2017, p. 13). The Levy County Code of Ordinances (Levy County 2023, pp. 6-12) requires the protection of environmentally sensitive lands and coordination with Florida Fish and Wildlife Commission and the Service regarding potential impacts to endangered or threatened species or their habitats.
The City of Cedar Key has a variety of land uses: residential, conservation, recreation, marsh, mixed use, commercial, and public (City of Cedar Key 2018, p. 145). City Code 4-3.2 states that “the City shall protect native vegetation, including but not limited to trees, mangroves, and marsh grasses, and cooperate with Levy County in identifying, conserving, protecting or preserving unique vegetative communities in contiguous areas to assure that development does not degrade the environment, impair aesthetics, damage coastal resources or deny reasonable property rights and uses” (City of Cedar Key 2018, p. 169). City Code 4-8.1 states, “a minimum coastal construction setback line of 50 feet (15 meters) from the mean high-water line will be maintained on any land adjoining all surface waters. In addition to the 50 feet (15 meters) setback line, an additional setback may be required to protect water-dependent vegetation located landward of the coastal construction setback line” (City of Cedar Key 2018, p. 172). These setbacks from beach habitat allow Cedar Keys mole skink habitat along the shoreline to remain intact. The city also has plans to manage and protect all ecological and wildlife communities (City of Cedar Key 2018, pp. 271-273).
The Florida Gulf Coast Mitigation Bank (Mitigation Bank) consists of approximately 1,587 acres (642 hectares) of habitat in Levy County owned and managed by the Mitigation Banking Group, Incorporated. The Mitigation Bank is characterized by coastal habitats, including maritime hammocks, coastal scrub, and both
Florida's Nature Coast Conservancy (Conservancy) is a nonprofit land trust dedicated to acquiring land for preservation, conservation, and/or public recreation. The Conservancy has protected at least 11 properties throughout the Cedar Keys and ensures sustainable land management protocols are in place for each. Two of the proposed critical habitat units (see II. Critical Habitat, below) for the Cedar Key mole skink are within the Conservancy's properties, and the protection and management of these areas will provide benefits to the Cedar Key mole skink.
The Cedar Key mole skink also occurs within three State Parks, including Cedar Key Museum State Park, Cedar Key Scrub Wildlife Management Area, and Cedar Key Scrub State Reserve. Active management of these parks provides indirect benefits to the Cedar Key mole skink by protecting and providing habitat through beach restoration and nourishment and nonnative plant and animal control. Part of the active management of these parks includes the Florida Parks Service conducting nonnative plant and animal control that benefits Cedar Key mole skinks.
The Cedar Key mole skink occurs within two National Wildlife Refuges: the Lower Suwanee and Cedar Keys National Wildlife Refuges. Specific management or conservation objectives for the Cedar Key mole skink are not identified in the management plans for these National Wildlife Refuges lands; however, ongoing management activities, including habitat restoration and nonnative species control, provide benefits to the Cedar Key mole skink and its habitat.
We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on the subspecies. To assess the current and future condition of the subspecies, we evaluate the effects of all the relevant factors that may be influencing the subspecies, including threats and conservation efforts. Because the SSA framework not only considers the presence of the factors, but to what degree they collectively influence risk to the entire subspecies, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative-effects analysis.
Due to the semi-fossorial and cryptic nature of the Cedar Key mole skink, abundance data are lacking, and no population trend data exist for this subspecies. There are also no data available regarding the population structure or demographics of the Cedar Key mole skink. There have been 215 detections of Cedar Key mole skinks on 10 islands, with 62 individuals documented on 8 islands since 2000. Two of these island populations are considered to have uncertain status given the last detections were in 1988 and 1993. In total, 191 acres (77 hectares) of preferred habitats (this includes sand, beach, and coastal dune habitats) are currently estimated on all ten islands where Cedar Key mole skinks have been detected.
Table 1, below, provides a summary of the projected magnitude of change in resiliency for populations of the Cedar Key mole skink for the 3-foot (ft) (0.9-meter) sea level rise scenario in 2040. In the “Population status” column of table 1, “current” means occupied in 2000-2022, and “uncertain” means occupied prior to 1999. In the “Year 2040 (3-ft sea level rise)” column, we use symbols as follows:
• ↓ means a slight decrease in population resiliency (more than 10 percent but less than or equal to 50 percent);
• ↓↓ means a moderate decrease in population resiliency (more than 50 percent but less than or equal to 75 percent);
• ↓↓↓ means a large decrease in population resiliency (more than 75 percent but less than or equal to 90 percent); and
•
To date, sea level rise has resulted in the direct loss of habitat, as beaches have become inundated for long periods of time. Repeated high tide flooding has resulted in additional loss of habitat as frequently flooded areas become unusable to the Cedar Key mole skink (individuals cannot easily move through wet sand; individuals or nests are washed away). Within the near term (by 2040 or sooner), five of the eight current populations are projected to lose 75 to 90 percent or more of preferred habitat due to continued increases in sea level rise and high tide flooding (table 1). In addition, recent hurricanes (Hurricane Hermine in 2016 and Hurricane Idalia in 2023) have resulted in direct loss of habitat as well as higher storm surge and coastal flooding that has further reduced availability and quality of Cedar Key mole skink habitat. Future projections indicate an increase in the severity of these storms.
Given the current impacts of sea level rise, high tide flooding, and hurricanes, and given the limited available habitat, the relatively low number of individuals documented, and the potential for repeated catastrophic storm events, the overall resiliency of the Cedar Key mole skink is considered low.
Redundancy is the ability of a species to withstand catastrophic events. In the Cedar Keys, tropical storms and hurricanes are regular and common events. However, catastrophic events may include particularly strong or intense hurricanes or storms and the resulting winds, waves, and storm surges associated with these events. Increased intensity of such storms associated with climate change could further reduce the ability of Cedar Key mole skink populations to recover and could cause catastrophic impacts to the subspecies.
Land mass in the Cedar Keys in general is limited, thus providing less redundancy or “backup” for the available habitat such that natural expansion of the subspecies is not possible. Given its small geographic range (eight islands within a length of 10 miles (16 kilometers)), the entire subspecies is vulnerable to potential catastrophic events such as a storm or hurricane that would likely impact all islands.
The Cedar Key mole skink has limited representation. There is no evidence of morphological or behavioral differences (or “types”) among populations. The Cedar Key mole skink occurs across a narrow geographic and ecological range; there is no variation in habitat types across distance or elevations. Furthermore, dispersal of individuals across islands is considered very rare, and genetic evidence shows little to no sign of interbreeding between the identified island populations (Parkinson et al. 2016, entire).
As part of the SSA, we also developed sea level rise and high tide flooding future condition scenarios projected out until the year 2100. Our scenarios included intermediate, intermediate-high, and high scenarios, which are aligned with emissions-based, conditional probabilistic and global model projections of global mean sea level rise (Service 2023, p. 42). Because we determined that the current condition of the Cedar Key mole skink is consistent with an endangered species (see Determination of Cedar Key Mole Skink's Status, below), we are not presenting the detailed results of the future scenarios in this proposed rule. Please refer to the SSA report (Service 2023, pp. 41-50) for the full analysis of future scenarios.
Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether a species meets the definition of an endangered species or a threatened species because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.
We presented summary evaluations of the primary threats analyzed in the SSA report including climate change, specifically sea level rise, increased high tide flooding, and increased intensity of storm events (Factor E). We also evaluated existing regulatory mechanisms (Factor D) and ongoing conservation measures. In the SSA report, we also considered additional threats: habitat loss and degradation that results from development (Factor A); overutilization due to recreational, educational, and scientific use (Factor B); disease (Factor C); oil spills (Factor E); and nonnative species (Factor E). We concluded that, as indicated by the best available scientific and commercial information, these additional threats currently have little to no impact on the Cedar Key mole skink and its habitat such that the overall effect now and into the future is expected to be minimal. However, we consider each of these threats in the determination for the subspecies, because although they may have low impacts on their own, combined with impacts of other threats, they could further reduce the already low number of Cedar Key mole skinks.
After evaluating threats to the subspecies and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we have determined that the Cedar Key mole skink has limited resiliency, redundancy, and representation to maintain viability over time. Only 62 skinks have been documented on eight islands in the last 20 years. Given the historical and current impacts from sea level rise, high tide flooding, and hurricanes, habitat for the Cedar Key mole skink is limited. In total, approximately 191 acres (77 hectares) of preferred habitat are currently estimated on islands where the Cedar Key mole skink has been detected. Because the subspecies is limited to a relatively small area (eight islands within a length of 10 miles (16 kilometers)), the subspecies is considered to have little redundancy. A single catastrophic event, such as a severe storm or hurricane, could result in the extinction of the subspecies. Additionally, given the subspecies' narrow range and limited-to-no island dispersal capabilities, we consider the subspecies to have low representation. The current and future projected increase in sea level rise, high tide flooding, and storm events exacerbates the current condition for the Cedar Key mole skink. We do not find that the Cedar Key mole skink meets the Act's definition of a threatened species because it already has shown declines in available habitat, has limited abundance, and its population's exhibit low resiliency. Because of the Cedar Key mole skink's low redundancy and limited representation, the subspecies is vulnerable to catastrophic storm events. Thus, after assessing the best available information, we conclude that the Cedar Key mole skink is in danger of extinction throughout all of its range.
Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. We have determined that the Cedar Key mole skink is in danger of extinction throughout all of its range and accordingly did not undertake an analysis of any significant portion of its range. Because the Cedar Key mole skink warrants listing as endangered throughout all of its range, our determination does not conflict with the decision in
Our review of the best available scientific and commercial information indicates that the Cedar Key mole skink meets the Act's definition of an endangered species. Therefore, we propose to list the Cedar Key mole skink as an endangered species in accordance with sections 3(6) and 4(a)(1) of the Act.
Conservation measures provided to species listed as endangered or threatened species under the Act include recognition as a listed species, planning and implementation of recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies, foreign governments, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies, including the Service, and the prohibitions against certain activities are discussed, in part, below.
The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Section 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.
The recovery planning process begins with development of a recovery outline made available to the public soon after a final listing determination. The recovery outline guides the immediate implementation of urgent recovery actions while a recovery plan is being developed. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) may be established to develop and implement recovery plans. The recovery planning process involves the identification of actions that are necessary to halt and reverse the species' decline by addressing the threats to its survival and recovery. The recovery plan identifies recovery criteria for review of when a species may be ready for reclassification from endangered to threatened (“downlisting”) or removal from protected status (“delisting”), and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery outline, draft recovery plan, final recovery plan, and any revisions will be available on our website as they are completed (
Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (
If this subspecies is listed, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Florida would be eligible for Federal funds to implement management actions that promote the protection or recovery of the Cedar Key mole skink. Information on our grant programs that are available to aid species recovery can be found at:
Although the Cedar Key mole skink is only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for this subspecies. Additionally, we invite you to submit any new information on this subspecies whenever it becomes available and any information you may have for recovery planning purposes (see
Section 7 of the Act is titled, “Interagency Cooperation,” and it mandates all Federal action agencies to use their existing authorities to further the conservation purposes of the Act and to ensure that their actions are not likely to jeopardize the continued existence of listed species or adversely modify critical habitat. Regulations implementing section 7 are codified at 50 CFR part 402.
Section 7(a)(2) states that each Federal action agency shall, in consultation with the Secretary, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Each Federal agency shall review its action at the earliest possible time to determine whether it may affect listed species or critical habitat. If a determination is made that the action may affect listed species or critical habitat, formal consultation is required (50 CFR 402.14(a)), unless the Service concurs in writing that the action is not likely to adversely affect listed species or critical habitat. At the end of a formal consultation, the Service issues a biological opinion, containing its determination of whether the Federal action is likely to result in jeopardy or adverse modification.
In contrast, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of critical habitat proposed to be designated for such species. Although the conference procedures are required only when an action is likely to result in jeopardy or adverse modification,
Examples of discretionary actions for the Cedar Key mole skink that may be subject to conference and consultation procedures under section 7 are land management or other landscape-altering activities on Federal lands administered by the Service as well as actions on State, Tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251
The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, and the Service's implementing regulations codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit, or to cause to be committed any of the following acts with regard to endangered wildlife: (1) import into, or export from, the United States; (2) take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct) within the United States, within the territorial sea of the United States, or on the high seas; (3) possess, sell, deliver, carry, transport, or ship, by any means whatsoever, any such wildlife that has been taken illegally; (4) deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or (5) sell or offer for sale in interstate or foreign commerce. Certain exceptions to these prohibitions apply to employees or agents of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.
We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits for endangered wildlife are codified at 50 CFR 17.22, and general Service permitting regulations are codified at 50 CFR part 13. With regard to endangered wildlife, a permit may be issued: for scientific purposes, for enhancing the propagation or survival of the species, or for take incidental to otherwise lawful activities. The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.
Critical habitat is defined in section 3 of the Act as:
(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features
(a) Essential to the conservation of the species, and
(b) Which may require special management considerations or protection; and
(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Our regulations at 50 CFR 424.02 define the geographical area occupied by the species as an area that may generally be delineated around species' occurrences, as determined by the Secretary (
Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.
Critical habitat receives protection under section 7 of the Act through the requirement that each Federal action agency ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of designated critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation also does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Rather, designation requires that, where a landowner requests Federal agency funding or authorization for an action that may affect an area designated as critical habitat, the Federal agency consult with the Service under section 7(a)(2) of the Act. If the action may affect the listed species itself (such as for occupied critical habitat), the Federal agency would have already been required to consult with the Service even absent the designation because of the requirement to ensure that the action is not likely to jeopardize the continued existence of the species. Even if the Service were to conclude after consultation that the proposed activity is likely to result in destruction or adverse modification of the critical habitat, the Federal action agency and the landowner are not required to abandon the proposed activity, or to restore or recover the species; instead, they must implement “reasonable and prudent alternatives” to avoid destruction or adverse modification of critical habitat.
Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific data available, those physical or biological features that are essential to the conservation of the species (such as
Under the second prong of the Act's definition of critical habitat, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the
When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information from the SSA report and information developed during the listing process for the species. Additional information sources may include any generalized conservation strategy, criteria, or outline that may have been developed for the species; the recovery plan for the species; articles in peer-reviewed journals; conservation plans developed by States and counties; scientific status surveys and studies; biological assessments; other unpublished materials; or experts' opinions or personal knowledge.
Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act; (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species; and (3) the prohibitions found in section 9 of the Act. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will continue to contribute to recovery of the species. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of those planning efforts calls for a different outcome.
In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12(b), in determining which areas we will designate as critical habitat from within the geographical area occupied by the species at the time of listing, we consider the physical or biological features that are essential to the conservation of the species and which may require special management considerations or protection. The regulations at 50 CFR 424.02 define “physical or biological features essential to the conservation of the species” as the features that occur in specific areas and that are essential to support the life-history needs of the species, including, but not limited to, water characteristics, soil type, geological features, sites, prey, vegetation, symbiotic species, or other features. A feature may be a single habitat characteristic or a more complex combination of habitat characteristics. Features may include habitat characteristics that support ephemeral or dynamic habitat conditions. Features may also be expressed in terms relating to principles of conservation biology, such as patch size, distribution distances, and connectivity. For example, physical features essential to the conservation of the species might include gravel of a particular size required for spawning, alkaline soil for seed germination, protective cover for migration, or susceptibility to flooding or fire that maintains necessary early-successional habitat characteristics. Biological features might include prey species, forage grasses, specific kinds or ages of trees for roosting or nesting, symbiotic fungi, or absence of a particular level of nonnative species consistent with conservation needs of the listed species. The features may also be combinations of habitat characteristics and may encompass the relationship between characteristics or the necessary amount of a characteristic essential to support the life history of the species.
In considering whether features are essential to the conservation of the species, we may consider an appropriate quality, quantity, and spatial and temporal arrangement of habitat characteristics in the context of the life-history needs, condition, and status of the species. These characteristics include, but are not limited to, space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, or rearing (or development) of offspring; and habitats that are protected from disturbance.
We derive the specific physical or biological features essential to the conservation of the Cedar Key mole skink from studies of the subspecies' habitat, ecology, and life history as described above. Additional information can be found in the SSA report (Service 2023, entire; available on
(a) Suitable soils (dry, loose, sandy, permeable, or friable soils) for movement and nesting; and
(b) Sufficient, appropriate ground cover (including, but not limited to, tidal wrack deposited above the mean high-water line, leaf litter, and vegetative debris) for protection from predators and temperature extremes, sources of food (
When designating critical habitat, we assess whether the specific areas within the geographical area occupied by the subspecies at the time of listing contain features which are essential to the conservation of the subspecies and which may require special management
Management activities that could ameliorate these threats include (but are not limited to): maintaining and protecting suitable habitat within occupied areas; identifying areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implementing nourishment or restoration/protection activities; conducting restoration and debris cleanup after storms, while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establishing protocols and agreements to allow storm-enhanced habitats (storms can create berms and dunes and can redeposit sand and wrack, which are all beneficial to the Cedar Key mole skink) to persist; coordinating with landowners and local managers to implement best management practices during regular beach cleaning activities; conducting public outreach and education at all occupied areas; and preparing disaster response plans and conducting trainings that consider Cedar Key mole skinks and their habitat.
As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. In accordance with the Act and our implementing regulations at 50 CFR 424.12(b), we review available information pertaining to the habitat requirements of the species and identify specific areas within the geographical area occupied by the species at the time of listing and any specific areas outside the geographical area occupied by the species to be considered for designation as critical habitat.
We are proposing to designate critical habitat in areas within the geographical area occupied by the subspecies at the time of listing. We also are proposing to designate specific areas outside the geographical area occupied by the subspecies because we have determined that those areas are essential for the conservation of the subspecies. By the year 2040, five out of eight islands currently occupied by the Cedar Key mole skink are projected to lose 75 to 90 percent or more of their preferred habitat under the lowest projected sea level rise scenario of 3.0 feet (0.9 meters) (see table 1, above). We identified suitable habitat on islands within the Cedar Keys that meet the definition of critical habitat and are considered essential to provide for subspecies redundancy into the future. These islands are considered areas with high resiliency to sea level rise (
We developed the following criteria for determining the specific areas that contain the physical and biological feature essential to the conservation of the subspecies:
(1) Genetic differentiation and geographic extent—To maintain viability in populations of Cedar Key mole skink that represent and conserve any genetic variation that may exist and habitat on each of the eight islands that has current populations (see
(2) Climate change resilience—To provide sufficient amounts of suitable habitat for the Cedar Key mole skink predicted to be less affected by sea level rise (Service 2023, pp. 41-50), critical habitat should include islands that are less vulnerable to sea level rise within the Cedar Keys.
(3) Structural connectivity—To maintain, enhance, and establish connectivity within Cedar Key mole skink populations (see Summary of Biological Status and Threats, above), critical habitat units should incorporate corridors for connectivity, dispersal, and refuge areas during high tide flooding and storm events.
Sources of data used for the delineation of critical habitat units included:
(1) Confirmed presence data compiled in our Geographic Information System database from 1951 through 2022, and provided by multiple databases maintained by museums, universities, and State agencies in Florida; State agency reports; and numerous survey reports for projects throughout the subspecies' range.
(2) Habitat and land use cover types from the Cooperative Land Cover map (version 3.5) developed by the Florida Fish and Wildlife Conservation Commission and Florida Natural Areas Inventory (FWC and FNAI 2021, entire) determined to be suitable for the subspecies based on peer-reviewed articles on this subspecies or similar subspecies, and gray literature by researchers involved in wildlife biology and conservation activities.
(3) Levy County soil data layers from the U.S. Department of Agriculture's Natural Resources Conservation Service Web Soil Survey (USDA 2022, entire) determined to be suitable for the subspecies based on their official soil series descriptions.
(4) Shoreline data representing the mean high-water line from the National Oceanic and Atmospheric Administration's Office of Coastal Management (
(5) Global and regional sea level rise scenarios for the United States from the National Oceanic and Atmospheric Administration's National Ocean Service Center for Operational Oceanographic Products and Services (Sweet et al. 2022, entire).
(6) Environmental Systems Research Institute's (ESRI's) Aeronautical Reconnaissance Coverage Geographical Information System (ArcPro) online basemap aerial imagery (2018 to 2020) to cross-check Cooperative Land Cover data and ensure the presence of the physical or biological feature.
For areas within the geographical area occupied by the Cedar Key mole skink at the time of listing, we delineated critical habitat unit boundaries using the following criteria:
(1) We determined occupied areas for this subspecies by reviewing the best available scientific and commercial data on occurrence records. As discussed above under I. Proposed Listing Determination, Background, Cedar Key mole skinks are cryptic and adapted to living underground. Because of their cryptic nature, we determined that, if suitable habitat containing the physical and biological feature is still present in an area where a Cedar Key mole skink was detected between 2000 and 2022, there is a high likelihood that the subspecies is still present. Therefore, based on the best available information, we defined occupied areas as islands with at least one current occurrence record ranging from 2000 to 2022.
(2) We selected all suitable habitat that contains the physical or biological feature as determined using the data sources listed above on currently occupied islands. When the exact location of an occurrence record could not be determined for an island (a verified record, but only general location information, such as the name of the island, was provided), or the location was accurate but in unsuitable habitat (developed areas), all suitable habitat on the island was selected.
(3) We selected additional suitable habitat within a 328-ft (100-meter) radius (the estimated home range of Cedar Key mole skink; Service 2023, p. 12) on undeveloped islands to include corridors for greater dispersal due to population expansions, localized resource limitations, and sea level rise, storm surge, or tidal flooding refugia areas for the subspecies (
(4) On developed islands, we constrained the boundary of a critical habitat unit to areas of contiguous suitable habitat. Offshore boundaries of the critical habitat unit were delineated using a simplified buffered shoreline to include the full extent of each island complex, or to the farthest offshore feature (
For areas outside the geographical area currently occupied by the subspecies at the time of listing, we looked at islands considered recently occupied by, or that have an uncertain status (documented before 1999) for, the Cedar Key mole skink. We analyzed these uncertain status islands and all other islands within the Cedar Keys for those that contain suitable habitat and evaluated each site for its potential conservation contribution based on quality of habitat, vulnerability to climate change (specifically sea level rise and high tide flooding), and existing protections and management of the habitat and sites. Based on these criteria, we identified nine islands that contain appropriate habitat for the subspecies and are essential for the conservation of the subspecies but would be considered unoccupied at the time of listing. For areas outside the geographical area occupied by the Cedar Key mole skink at the time of listing, we delineated critical habitat unit boundaries using the following criteria:
(1) To ensure unoccupied areas would provide skink habitat into the future, we analyzed impacts to potential habitat on each island in the Cedar Keys and included only those that are projected to still have habitat remaining after 5.0 feet (1.5 meters) of sea level rise and high tide flooding by the year 2080 (Service 2023, p. 47).
(2) We selected all suitable habitat that contains the physical or biological feature as determined using Criteria (2)-(4) outlined above for occupied units.
When determining proposed critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical or biological features necessary for the Cedar Key mole skink. The scale of the maps we prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed lands. Any such lands inadvertently left inside critical habitat boundaries shown on the maps of this proposed rule have been excluded by text in the proposed rule and are not proposed for designation as critical habitat. Therefore, if the critical habitat is finalized as proposed, a Federal action involving these lands would not trigger section 7 consultation with respect to critical habitat and the requirement of no adverse modification unless the specific action would affect the physical or biological features in the adjacent critical habitat.
Seventeen units are proposed for designation based on the physical or biological feature being present to support the Cedar Key mole skink's life-history processes. All units contain the identified physical or biological feature and support multiple life-history processes.
The proposed critical habitat designation is defined by the maps, as modified by any accompanying regulatory text, presented at the end of this document under Proposed Regulation Promulgation. We include more detailed information on the boundaries of the proposed critical habitat designation in the preamble of this document. We will make the coordinates or plot points or both on which each map is based available to the public on
We are proposing to designate approximately 2,713 acres (1,098 hectares) in 17 units as critical habitat for the Cedar Key mole skink (see table 2, below). The critical habitat areas we describe below constitute our current best assessment of areas that meet the definition of critical habitat for the Cedar Key mole skink. The 17 areas we propose as critical habitat are: (1) Live Oak Key, (2) Cedar Point, (3) Scale Key, (4) Dog Island, (5) Atsena Otie Key, (6) Snake Key, (7) Seahorse Key, (8) North Key, (9) Airstrip Island, (10) Way Key South, (11) Way Key North, (12) Richards Island, (13) Seabreeze Island, (14) Shell Mound, (15) Raleigh and Horse Islands, (16) Deer Island, and (17) Clark Islands. Most of the units contain highly dynamic barrier beaches and intertidal seashore. This area has the potential to vary year-to-year. In other words, the precise location of the physical and biological feature in some locations may shift over time somewhat because of the intrinsically dynamic nature of shorelines and due to sea level rise and high tide flooding. Table 2 shows the proposed critical habitat units and the approximate area of each unit.
We present brief descriptions of all proposed units, and reasons why they meet the definition of critical habitat for the Cedar Key mole skink, below.
Unit 1 encompasses approximately 109 acres (44 hectares) of unoccupied habitat in Levy County and includes the entire island of Live Oak Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 46 acres (19 hectares) in Federal ownership, 49 acres (20 hectares) in private ownership, and 14 acres (6 hectares) in other ownership (undefined ownership). The entirety of Unit 1 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot (
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 2 encompasses approximately 41 acres (17 hectares) of occupied habitat in Levy County and includes the entire island of Cedar Point. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 26 acres (11 hectares) in Federal ownership and 15 acres (6 hectares) in private ownership. The entirety of Unit 2 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot. Cedar Point is approximately 1.7 miles (2.7 kilometers) northeast of Cedar Key within the Gulf of Mexico. The Service manages most of the island as the part of the Cedar Keys National Wildlife Refuge. The eastern portion is managed by a private entity as part of the Florida Gulf Coast Mitigation Bank.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 3 encompasses approximately 116 acres (47 hectares) of occupied habitat in Levy County and includes the entire island of Scale Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 95 acres (38 hectares) in Federal ownership and 21 acres (8 hectares) in private ownership. The entirety of Unit 3 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot. Scale Key is approximately 1 mile (1.6 kilometers) northeast of Cedar Key within the Gulf of Mexico. The Service manages most of the island as part of the Cedar Keys National Wildlife Refuge. Approximately 14 acres (6 hectares) of the eastern portion are owned by Florida's Nature Coast Conservancy, and 5 acres (2 hectares) of the northern portion are managed by a private entity as part of the Florida Gulf Coast Mitigation Bank.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow
Unit 4 encompasses approximately 8 acres (3 hectares) of unoccupied habitat in Levy County and includes the entire Dog Island. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Although Dog Island is currently considered unoccupied, Cedar Key mole skinks were documented here in the past (Enge 2023, pers. comm.; FWC 2023, entire), and it is possible that they are still present.
Dog Island is approximately 1 mile (1.6 kilometers) to the east of Cedar Key within the Gulf of Mexico. Lands within this unit are entirely within State ownership. The entirety of Unit 4 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 5 encompasses approximately 183 acres (74 hectares) of occupied habitat in Levy County and includes the entire island of Atsena Otie Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 116 acres (47 hectares) in State ownership and 67 acres (27 hectares) in other ownership. Atsena Otie Key is approximately 1 mile (1.6 kilometers) south of Cedar Key within the Gulf of Mexico. The island is owned by the State of Florida and managed as part of the Cedar Keys National Wildlife Refuge through a memorandum of understanding (MOU) by the Service. The entirety of Unit 5 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 6 encompasses approximately 57 acres (23 hectares) of occupied habitat within Levy County and includes the entire island of Snake Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 39 acres (16 hectares) in Federal ownership and 17 acres (7 hectares) in other ownership. Snake Key is approximately 2.5 miles (4 kilometers) south of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Cedar Keys National Wildlife Refuge. The entirety of Unit 6 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 7 encompasses approximately 165 acres (67 hectares) of occupied habitat within Levy County and includes the entire island of Seahorse Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 118 acres (48 hectares) in Federal ownership and 47 acres (19 hectares) in other ownership. Seahorse Key is approximately 3 miles (5 kilometers) south and west of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Cedar Keys National Wildlife Refuge. The entirety of Unit 7 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 8 encompasses approximately 236 acres (95 hectares) of occupied habitat within Levy County and includes the entire island of North Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 129 acres (52 hectares) in Federal ownership and 107 acres (43 hectares) in other ownership. North Key is approximately 3 miles (4.8 kilometers) to the west of Cedar Key within the Gulf of Mexico. The island is
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 9 encompasses approximately 29 acres (12 hectares) of occupied habitat within Levy County on the island of Way Key. Lands within this unit include approximately 19 acres (8 hectares) in local government ownership and 10 acres (4 hectares) in private ownership. This unit is composed of the following five separate sections with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies: Airstrip Island Beach, Cedar Key Airport, Airport Island, Piney Point, and Robert Cull Nature Preserve. Airstrip Island Beach is 5 acres (2 hectares) of private shoreline along Daughtry Bayou, encompassing sandy beach from mean higher high-water inland to dense vegetation, hardened structures, or roads, extending from the southern side of the Airport Road bridge to the south for approximately 0.5 miles (0.8 kilometers). Cedar Key Airport includes 16 acres (6 hectares) of unvegetated and vegetated sandy soils on the George T. Lewis Airport (also known as the Cedar Key Airport) that are owned by Levy County. Airport Island is a 2-acre (0.8-hectare), unnamed island southwest of the airport, which is also owned by Levy County. Piney Point is a 3-acre (1-hectare), privately owned, undeveloped, vacant lot on the western side of Piney Point south of the airport. The fifth section is 2 acres (0.8 hectares) of protected land known as the Robert Cull Nature Preserve at the terminus of Piney Point that are owned and managed by Florida's Nature Coast Conservancy. Approximately 9 acres (4 hectares) of Unit 9 overlap with proposed critical habitat for the rufa red knot.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 10 encompasses approximately 44 acres (18 hectares) of unoccupied habitat within Levy County on Way Key. This unit is a series of undeveloped disconnected islands south of Way Key that contain the physical or biological feature essential to the conservation of the subspecies. The largest island, located between the airport and the developed portion of Way Key, is projected to be more resilient to sea level rise (due to its relatively higher elevation) and is composed of coastal scrub habitat with a sandy shoreline fringe. Also included in this unit are several primarily sand islands that occur seaward of the main island. This unit is entirely in State ownership. Approximately 41 acres (17 hectares) of Unit 10 overlap with proposed critical habitat for the rufa red knot.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 11 encompasses approximately 24 acres (10 hectares) of unoccupied habitat within Levy County on Way Key. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 9 acres (4 hectares) in State ownership managed as the Cedar Key Museum State Park by the Florida Park Service, and 15 acres (6 hectares) in local government ownership managed as Cemetery Point Park by the City of Cedar Key. Although the unit is currently considered unoccupied, Cedar key mole skinks were documented here in the past (FWC 2023, entire), and it is possible that they are still present. Additionally, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 12 encompasses approximately 105 acres (42 hectares) of unoccupied habitat within Levy County and includes the entirety of Richards Island. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Richards Island is undeveloped and projected to be more resilient to sea level rise due to higher elevation. Lands within this unit include approximately 86 acres (35 hectares) in Federal ownership and 19 acres (8 hectares) in other ownership. Richards Island is approximately 3.3 miles (5.3 kilometers) northwest of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Cedar Keys National Wildlife Refuge. Approximately 43 acres (17 hectares) of Unit 12 overlap with proposed critical habitat for the rufa red knot.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the
Unit 13 encompasses approximately 136 acres (55 hectares) of unoccupied habitat within Levy County on Seabreeze Island. This unit is composed of protected lands with suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Seabreeze Island is undeveloped and projected to be more resilient to sea level rise. Lands within this unit include approximately 111 acres (45 hectares) in Federal ownership and 25 acres (10 hectares) in other ownership. Seabreeze Island is approximately 4 miles (6 kilometers) northwest of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Lower Suwannee National Wildlife Refuge. Approximately 8 acres (3 hectares) of Unit 13 overlap with proposed critical habitat for the rufa red knot.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 14 encompasses approximately 1,050 ac (425 hectares) of unoccupied habitat within Levy County on Shell Mound. The unit contains higher elevation lands, is projected to be more resilient to sea level rise, and has suitable habitat containing the physical or biological feature essential to the conservation of the subspecies. This unit extends from Dennis Creek north to Ericson Creek. Lands within this unit include approximately 167 acres (68 hectares) in Federal ownership, 194 acres (79 hectares) in State ownership, and 688 acres (278 hectares) in private ownership. The unit includes portions of the Cedar Key Scrub State Reserve managed by the Florida Park Service and the Lower Suwannee National Wildlife Refuge managed by the Service.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 15 encompasses approximately 176 acres (71 hectares) of unoccupied habitat within Levy County on Raleigh and Horse Islands. The unit includes undeveloped islands projected to be more resilient to sea level rise and contains suitable habitat with the physical or biological feature essential to the conservation of the subspecies. Lands within this unit include approximately 171 acres (69 hectares) in Federal ownership and 5 acres (2 hectares) in private ownership. The group of islands is approximately 6 miles (10 kilometers) northwest of Cedar Key within the Gulf of Mexico. The Service manages most of the islands as part of the Lower Suwannee National Wildlife Refuge.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Unit 16 encompasses approximately 113 acres (46 hectares) of occupied habitat within Levy County and includes the entirety of Deer Island. The unit is composed of suitable habitat that contains the physical or biological feature essential to the conservation of the subspecies. Lands within the unit include approximately 8 acres (3 hectares) in Federal ownership, 69 acres (28 hectares) in private ownership, and 36 acres (15 hectares) in other ownership. Deer Island is approximately 7 miles (11 kilometers) northwest of Cedar Key within the Gulf of Mexico. The entirety of Unit 16 is included in, and thus overlaps with, proposed critical habitat for the rufa red knot.
The physical and biological feature in this unit may require special management considerations or protection to: identify areas where beach erosion is occurring or habitat is succeeding to mangrove swamp or other coastal wetlands due to sea level rise and implement renourishment or restoration/protection activities; conduct restoration and debris cleanup after storms while concurrently minimizing disturbance to Cedar Key mole skinks and their habitat; establish protocols and agreements to allow storm-enhanced habitats to persist; conduct public outreach and education; and prepare disaster response plans and conduct trainings that consider Cedar Key mole skinks and their habitat to address threats from climate change (
Unit 17 encompasses approximately 121 acres (49 hectares) of unoccupied habitat within Levy County on the Clark Islands complex. The unit includes undeveloped islands projected to be more resilient to sea level rise. The entirety of the unit is privately owned. The Clark Islands are approximately 7 miles (11 kilometers) north-northwest of Cedar Key within the Gulf of Mexico.
Although it is currently considered unoccupied, this unit constitutes habitat for the subspecies because it contains the physical or biological feature necessary for the life history of the subspecies. This unit is essential for the conservation of the subspecies because it will provide habitat for potential reintroductions in the case of sea level rise and high tide flooding (Service 2023, pp. 41-50) or stochastic events (such as hurricanes) should other areas of suitable habitat be destroyed or the Cedar Key mole skink be extirpated from one of its currently occupied locations.
Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of
Destruction or adverse modification means a direct or indirect alteration that appreciably diminishes the value of critical habitat as a whole for the conservation of a listed species.
Compliance with the requirements of section 7(a)(2) of the Act is documented through our issuance of:
(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or
(2) A biological opinion for Federal actions that may affect, and are likely to adversely affect, listed species or critical habitat.
When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species and/or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during formal consultation that:
(1) Can be implemented in a manner consistent with the intended purpose of the action,
(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,
(3) Are economically and technologically feasible, and
(4) Would, in the Service Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species or avoid the likelihood of destroying or adversely modifying critical habitat.
Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.
Regulations at 50 CFR 402.16 set forth requirements for Federal agencies to reinitiate consultation. Reinitiation of consultation is required and shall be requested by the Federal agency, where discretionary Federal involvement or control over the action has been retained or is authorized by law and: (1) If the amount or extent of taking specified in the incidental take statement is exceeded; (2) if new information reveals effects of the action that may affect listed species or critical habitat in a manner or to an extent not previously considered; (3) if the identified action is subsequently modified in a manner that causes an effect to the listed species or critical habitat that was not considered in the biological opinion or written concurrence; or (4) if a new species is listed or critical habitat designated that may be affected by the identified action. As provided in 50 CFR 402.16, the requirement to reinitiate consultations for new species listings or critical habitat designation does not apply to certain agency actions (
The key factor related to the destruction or adverse modification determination is whether implementation of the proposed Federal action directly or indirectly alters the designated critical habitat in a way that appreciably diminishes the value of the critical habitat as a whole for the conservation of the listed species. As discussed above, the role of critical habitat is to support physical or biological features essential to the conservation of a listed species and provide for the conservation of the species.
Section 4(b)(8) of the Act requires that our
Section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) provides that the Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense (DoD), or designated for its use, that are subject to an integrated natural resources management plan (INRMP) prepared under section 101 of the Sikes Act Improvement Act of 1997 (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation. No DoD lands with a completed INRMP are within the proposed critical habitat designation.
Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from designated critical habitat based on economic impacts, impacts on national security, or any other relevant impacts. Exclusion decisions are governed by the regulations at 50 CFR 424.19 and the Policy Regarding Implementation of Section 4(b)(2) of the Endangered Species Act (hereafter, the “2016 Policy”; 81 FR 7226, February 11, 2016), both of which were developed jointly with the National Marine Fisheries Service (NMFS). We also refer to a 2008 Department of the Interior Solicitor's opinion entitled, “The Secretary's Authority to Exclude Areas from a Critical Habitat Designation under Section 4(b)(2) of the Endangered Species Act” (M-37016).
In considering whether to exclude a particular area from the designation, we identify the benefits of including the area in the designation, identify the benefits of excluding the area from the designation, and evaluate whether the benefits of exclusion outweigh the benefits of inclusion. If the analysis indicates that the benefits of exclusion outweigh the benefits of inclusion, the Secretary may exercise discretion to exclude the area only if such exclusion would not result in the extinction of the species. In making the determination to exclude a particular area, the statute on its face, as well as the legislative history, are clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor. In our final rules, we explain any decision to exclude areas, as well as decisions not to exclude, to make clear the rational basis for our decision. We describe below the process that we use for taking into consideration each
Section 4(b)(2) of the Act and its implementing regulations require that we consider the economic impact that may result from a designation of critical habitat. To assess the probable economic impacts of a designation, we must first evaluate specific land uses or activities and projects that may occur in the area of the critical habitat. We then must evaluate the impacts that a specific critical habitat designation may have on restricting or modifying specific land uses or activities for the benefit of the species and its habitat within the areas proposed. We then identify which conservation efforts may be the result of the species being listed under the Act versus those attributed solely to the designation of critical habitat for this particular species. The probable economic impact of a proposed critical habitat designation is analyzed by comparing scenarios both “with critical habitat” and “without critical habitat.”
The “without critical habitat” scenario represents the baseline for the analysis, which includes the existing regulatory and socio-economic burden imposed on landowners, managers, or other resource users potentially affected by the designation of critical habitat (
Executive Order (E.O.) 14094 supplements and reaffirms E.O. 12866 and E.O. 13563 and directs Federal agencies to assess the costs and benefits of available regulatory alternatives in quantitative (to the extent feasible) and qualitative terms. Consistent with the E.O. regulatory analysis requirements, our effects analysis under the Act may take into consideration impacts to both directly and indirectly affected entities, where practicable and reasonable. If sufficient data are available, we assess to the extent practicable the probable impacts to both directly and indirectly affected entities. Section 3(f) of E.O. 12866 identifies four criteria when a regulation is considered a “significant regulatory action” and requires additional analysis, review, and approval if met. The criterion relevant here is whether the designation of critical habitat may have an economic effect of $200 million or more in any given year (section 3(f)(1) as amended by E.O. 14094). Therefore, our consideration of economic impacts uses a screening analysis to assess whether a designation of critical habitat for the Cedar Key mole skink is likely to exceed the economically significant threshold.
For this particular designation, we developed an incremental effects memorandum (IEM) considering the probable incremental economic impacts that may result from this proposed designation of critical habitat. The information contained in our IEM was then used to develop a screening analysis of the probable effects of the designation of critical habitat for the Cedar Key mole skink (IEc 2023, entire). We began by conducting a screening analysis of the proposed designation of critical habitat in order to focus our analysis on the key factors that are likely to result in incremental economic impacts. The purpose of the screening analysis is to filter out particular geographical areas of critical habitat that are already subject to such protections and are, therefore, unlikely to incur incremental economic impacts. In particular, the screening analysis considers baseline costs (
As part of our screening analysis, we considered the types of economic activities that are likely to occur within the areas likely affected by the critical habitat designation. In our evaluation of the probable incremental economic impacts that may result from the proposed designation of critical habitat for the Cedar Key mole skink, first we identified, in the IEM dated August 22, 2023, probable incremental economic impacts associated with the following categories of activities: (1) residential and commercial development; (2) construction activities such as road and bridge construction and maintenance; (3) habitat management activities (such as beach nourishment, shoreline armoring, nonnative species control (including mechanical or herbicide applications), and prescribed fire); and (4) recreational activities and associated developments (such as campgrounds, trails, and visitor facilities), management activities (such as beach raking or other cleaning methods to remove wrack and debris), and airport management activities. We considered each industry or category individually. Additionally, we considered whether their activities have any Federal involvement. Critical habitat designation generally will not affect activities that do not have any Federal involvement; under the Act, designation of critical habitat only affects activities conducted, funded, permitted, or authorized by Federal agencies. If we list the subspecies, in areas where the Cedar key mole skink is present, Federal agencies would be required to consult with the Service under section 7 of the Act on activities they authorize, fund, or carry out that may affect the subspecies. If we list the subspecies and also finalize this proposed critical habitat designation, Federal agencies would be required to consider the effects of their actions on the designated habitat, and if
In our IEM, we attempted to clarify the distinction between the effects that would result from the subspecies being listed and those attributable to the critical habitat designation (
The proposed critical habitat designation for the Cedar Key mole skink totals approximately 2,713 acres (1,098 hectares) in 17 units in Levy County, Florida (see Proposed Critical Habitat Designation, above). Land ownership across the units includes Federal lands (37 percent), State lands (14 percent), local lands (1 percent), private lands (36 percent), and lands with unknown/undefined ownership (12 percent). Eight of the 17 units are currently occupied by the Cedar Key mole skink; the remaining 9 units are not known to be currently occupied. Approximately 42 percent of the proposed critical habitat for the Cedar Key mole skink overlaps with currently proposed critical habitat for the rufa red knot. Further, 100 percent of the proposed critical habitat for the Cedar Key mole skink intersects with existing ranges for six federally listed species (IEc 2023, p. 8).
When an action is proposed in an area of designated critical habitat, and the proposed activity has a Federal nexus, the need for section 7 consultation is triggered. Any incremental costs associated with consideration of potential effects to the critical habitat are a result of this consultation process. For all occupied areas, the economic costs of critical habitat designations would most likely be limited to additional administrative efforts to consider adverse modification in section 7 consultations, as the listing of the subspecies is being proposed concurrently with critical habitat designation, and all occupied units would still need to undergo section 7 consultation due to listing regardless of critical habitat designation. While this additional analysis would require time and resources by both the Federal action agency and the Service, it is believed that, in most circumstances, these costs would predominantly be administrative in nature and would not be significant. For the unoccupied units, section 7 consultations would not occur if not for the presence of critical habitat, so additional costs would occur. In unoccupied habitat, the incremental cost associated with a new consultation considering only adverse modification during technical assistances, informal, formal, and programmatic consultations are estimated to be $1,300, $8,000, $17,000, and $31,000, respectively (IEc 2023, p. 18). These estimates assume that consultation would not occur in the absence of critical habitat designation. In total, the estimated annual, incremental administrative costs for a Cedar Key mole skink critical habitat designation are estimated at $9,000 annually (IEc 2023, p. 19). Overall, a critical habitat designation for the Cedar Key mole skink is unlikely to generate costs or benefits exceeding $200 million in a single year. Because of the relatively small size of the critical habitat designation, the landownership (Federal, State, county, or private) of the proposed critical habitat units, the amount of land that is already being managed for conservation, and the significant overlap with the rufa red knot's proposed critical habitat, the numbers of section 7 consultations expected annually are modest (approximately 1 formal, 12 informal, and 5 technical assistance efforts annually across the designation) (IEc 2023, p. 15).
Potential private property value effects are possible due to public perception of impacts to private lands. The designation of critical habitat may cause some developers or landowners to perceive that private lands will be subject to use restrictions or litigation from third parties, resulting in costs. However, due to the speculative nature of this perception, costs are not able to be quantified. Regardless, only 36 percent of the proposed critical habitat designation is privately owned land, leading to nominal incremental costs arising from changes in public perception of lands included in the designation.
Incremental costs may occur outside of the section 7 consultation process if the designation of critical habitat triggers additional requirements or project modifications under State or local laws, regulations, or management strategies. These types of costs typically occur if the designation increases awareness of the presence of the subspecies or the need for protection of its habitat. Given that the Cedar Key mole skink is covered by existing State protection plans, project proponents may already be aware of the presence of the subspecies. For example, the Cedar Key mole skink is included in the State of Florida's State Wildlife Action Plan as a species of greatest conservation need. The subspecies is further protected through habitat management and conservation under Florida State Park management plans. Therefore, designating critical habitat is unlikely to provide information to State or local agencies that would result in new regulations or actions (IEc 2023, p. 20).
We are soliciting data and comments from the public on the economic analysis discussed above (see Information Requested, above). During the development of a final designation, we will consider the information presented in the economic analysis and any additional information on economic impacts we receive during the public comment period to determine whether any specific areas should be excluded from the final critical habitat designation under authority of section 4(b)(2) of the Act, our implementing regulations at 50 CFR 424.19, and the 2016 Policy. We may exclude an area from critical habitat if we determine that the benefits of excluding the area outweigh the benefits of including the area, provided the exclusion will not result in the extinction of this subspecies.
Section 4(a)(3)(B)(i) of the Act may not cover all DoD lands or areas that pose potential national-security concerns (
However, we cannot automatically exclude requested areas. When DoD, DHS, or another Federal agency requests exclusion from critical habitat on the basis of national-security or homeland-security impacts, we must conduct an exclusion analysis if the Federal requester provides information, including a reasonably specific justification of an incremental impact on national security that would result from the designation of that specific area as critical habitat. That justification could include demonstration of probable impacts, such as impacts to ongoing border-security patrols and surveillance activities, or a delay in training or facility construction, as a result of compliance with section 7(a)(2) of the Act. If the agency requesting the exclusion does not provide us with a reasonably specific justification, we will contact the agency to recommend that it provide a specific justification or clarification of its concerns relative to the probable incremental impact that could result from the designation. If we conduct an exclusion analysis because the agency provides a reasonably specific justification or because we decide to exercise the discretion to conduct an exclusion analysis, we will defer to the expert judgment of DoD, DHS, or another Federal agency as to: (1) Whether activities on its lands or waters, or its activities on other lands or waters, have national-security or homeland-security implications; (2) the importance of those implications; and (3) the degree to which the cited implications would be adversely affected in the absence of an exclusion. In that circumstance, in conducting a discretionary section 4(b)(2) exclusion analysis, we will give great weight to national-security and homeland-security concerns in analyzing the benefits of exclusion.
In preparing this proposal, we have determined that the lands within the proposed designation of critical habitat for the Cedar Key mole skink are not owned or managed by the DoD or DHS, and, therefore, we anticipate no impact on national security or homeland security.
Under section 4(b)(2) of the Act, we consider any other relevant impacts, in addition to economic impacts and impacts on national security discussed above. To identify other relevant impacts that may affect the exclusion analysis, we consider a number of factors, including whether there are permitted conservation plans covering the species in the area—such as safe harbor agreements (SHAs), candidate conservation agreements with assurances (CCAAs), or “conservation benefit agreements” or “conservation agreements” (CBAs) (CBAs are a new type of agreement replacing SHAs and CCAAs in use after April 2024 (89 FR 26070; April 12, 2024)) or HCPs—or whether there are non-permitted conservation agreements and partnerships that would be encouraged by designation of, or exclusion from, critical habitat. In addition, we look at whether Tribal conservation plans or partnerships, Tribal resources, or government-to-government relationships of the United States with Tribal entities may be affected by the designation. We also consider any State, local, social, or other impacts that might occur because of the designation.
In preparing this proposal, we have determined that no HCPs or other management plans for the Cedar Key mole skink currently exist, and the proposed designation does not include any Tribal lands or trust resources or any lands for which designation would have any economic or national security impacts. Therefore, we anticipate no impact on Tribal lands, partnerships, or HCPs from this proposed critical habitat designation, and, thus, as described above, we are not considering excluding any particular areas on the basis of the presence of conservation agreements or impacts to trust resources.
However, if through this proposed rule's public comment period (see
We are required by E.O.s 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
Executive Order (E.O.) 14094 reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open
E.O. 12866, as reaffirmed by E.O. 13563 and E.O. 14094, provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this proposed rule is not significant.
Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601
According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine whether potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.
Under the RFA, as amended, and as understood in light of recent court decisions, Federal agencies are required to evaluate the potential incremental impacts of rulemaking on those entities directly regulated by the rulemaking itself; in other words, the RFA does not require agencies to evaluate the potential impacts to indirectly regulated entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried out by the agency is not likely to destroy or adversely modify critical habitat. Therefore, under section 7, only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Consequently, it is our position that only Federal action agencies would be directly regulated if we adopt the proposed critical habitat designation. The RFA does not require evaluation of the potential impacts to entities not directly regulated. Moreover, Federal agencies are not small entities. Therefore, because no small entities would be directly regulated by this rulemaking, the Service certifies that, if made final as proposed, the proposed critical habitat designation will not have a significant economic impact on a substantial number of small entities.
In summary, we have considered whether the proposed designation would result in a significant economic impact on a substantial number of small entities. For the above reasons and based on currently available information, we certify that, if made final, the proposed critical habitat designation would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.
Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare statements of energy effects “to the extent permitted by law” when undertaking actions identified as significant energy actions (66 FR 28355; May 22, 2001). E.O. 13211 defines a “significant energy action” as an action that (i) is a significant regulatory action under E.O. 12866 or any successor order; and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy. This rule is not a significant regulatory action under E.O. 12866 or E.O. 14094 (88 FR 21879; April 11, 2023). Therefore, this action is not a significant energy action, and there is no requirement to prepare a statement of energy effects for this action.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(1) This proposed rule would not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or Tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and Tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”
The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions are not likely to destroy or adversely modify critical habitat under section 7. While
(2) We do not believe that this proposed rule would significantly or uniquely affect small governments because it would not produce a Federal mandate of $100 million or greater in any year, that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. Therefore, a small government agency plan is not required.
In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of designating critical habitat for the Cedar Key mole skink in a takings implications assessment. The Act does not authorize the Service to regulate private actions on private lands or confiscate private property as a result of critical habitat designation. Designation of critical habitat does not affect land ownership, or establish any closures, or restrictions on use of or access to the designated areas. Furthermore, the designation of critical habitat does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. However, Federal agencies are prohibited from carrying out, funding, or authorizing actions that would destroy or adversely modify critical habitat. A takings implications assessment has been completed for the proposed designation of critical habitat for the Cedar Key mole skink, and it concludes that, if adopted, this designation of critical habitat does not pose significant takings implications for lands within or affected by the designation.
In accordance with E.O. 13132 (Federalism), this proposed rule does not have significant Federalism effects. A federalism summary impact statement is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of this proposed critical habitat designation with, appropriate State resource agencies. From a federalism perspective, the designation of critical habitat directly affects only the responsibilities of Federal agencies. The Act imposes no other duties with respect to critical habitat, either for States and local governments, or for anyone else. As a result, the proposed rule does not have substantial direct effects either on the States, or on the relationship between the Federal government and the States, or on the distribution of powers and responsibilities among the various levels of government. The proposed designation may have some benefit to these governments because the areas that contain the features essential to the conservation of the species are more clearly defined, and the physical or biological features of the habitat necessary for the conservation of the species are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist State and local governments in long-range planning because they no longer have to wait for case-by-case section 7 consultations to occur.
Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) of the Act would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.
In accordance with E.O. 12988 (Civil Justice Reform), the Office of the Solicitor has determined that this proposed rule would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. We have proposed designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the species, this proposed rule identifies the physical or biological features essential to the conservation of the species. The proposed areas of critical habitat are presented on maps, and the proposed rule provides several options for the interested public to obtain more detailed location information, if desired.
This rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Regulations adopted pursuant to section 4(a) of the Act are exempt from the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), the President's memorandum of November 30, 2022 (Uniform Standards for Tribal Consultation; 87 FR 74479, December 5, 2022), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with federally recognized Tribes and Alaska Native Corporations (ANCs) on a government-to-government basis. In accordance with Secretaries' Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for
A complete list of references cited in this rulemaking is available on the internet at
The primary authors of this proposed rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Florida Ecological Services Field Office.
Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.
Martha Williams, Director of the U.S. Fish and Wildlife Service, approved this action on June 14, 2024, for publication. On July 31, 2024, Martha Williams authorized the undersigned to sign the document electronically and submit it to the Office of the Federal Register for publication as an official document of the U.S. Fish and Wildlife Service.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(h) * * *
(c)
Cedar Key Mole Skink (
(1) Critical habitat units are depicted for Levy County, Florida, on the maps in this entry.
(2) Within these areas, the physical or biological feature essential to the conservation of the Cedar Key mole skink consists of natural habitats (including, but not limited to, beaches, dunes, and coastal hammocks) along the coast or within the interior of the Cedar Keys that contain:
(i) Suitable soils (dry, loose, sandy, permeable, or friable soils) for movement and nesting; and
(ii) Sufficient, appropriate ground cover (including, but not limited to, tidal wrack deposited above the mean high-water line, leaf litter, and vegetative debris) for protection from predators and temperature extremes, sources of food (
(3) Critical habitat does not include human-made structures (such as buildings, aqueducts, runways, roads, and other paved areas) and the land on which they are located existing within the legal boundaries on the effective date of the final rule.
(4) Data layers defining map units were created using Environmental Systems Research Institute's (ESRI's) Aeronautical Reconnaissance Coverage Geographical Information System (ArcPro) mapping software along with various spatial data layers. ArcPro was also used to calculate the size of habitat areas. The projection used in mapping and calculating distances and locations within the units was Albers Conical Equal Area (Florida Geographic Data Library), North American Datum of 1983 (NAD 83) High Accuracy Reference Network (HARN). The maps in this entry, as modified by any accompanying regulatory text, establish the boundaries of the critical habitat designation. The coordinates or plot points or both on which each map is based are available to the public at the Service's internet site at
(5) Index map follows:
(6)
(i) Unit 1 encompasses approximately 109 acres (44 hectares) and includes the entire island of Live Oak Key. Lands within this unit include approximately 46 acres (19 hectares) in Federal ownership, 49 acres (20 hectares) in private ownership, and 14 acres (6 hectares) in other ownership. Live Oak Key is approximately 2.5 miles (4 kilometers) northeast of Cedar Key within the Gulf of Mexico. The northern portion of the island is managed as the Florida Gulf Coast Mitigation Bank by a private entity and the southern portion is federally owned and managed by the Service as the part of the Cedar Keys National Wildlife Refuge.
(ii) Map of Units 1 and 2 follow:
(7)
(i) Unit 2 encompasses approximately 41 acres (17 hectares) and includes the entire island of Cedar Point. Lands within this unit include approximately 26 acres (11 hectares) in Federal ownership and 15 acres (6 hectares) in private ownership. Cedar Point is approximately 1.7 miles (2.7 kilometers) northeast of Cedar Key within the Gulf of Mexico. The Service manages most of the island as the part of the Cedar Keys National Wildlife Refuge. The eastern portion is managed by a private entity as part of the Florida Gulf Coast Mitigation Bank.
(ii) Map of Unit 2 is provided at paragraph (6)(ii) of this entry.
(8)
(i) Unit 3 encompasses approximately 116 acres (47 hectares) and includes the entire island of Scale Key. Lands within this unit include approximately 95 acres (38 hectares) in Federal ownership and 21 acres (8 hectares) in private ownership. Scale Key is approximately 1 mile (1.6 kilometers) northeast of Cedar Key within the Gulf of Mexico. The Service manages most of the island as part of the Cedar Keys National
(ii) Map of Units 3 and 4 follows:
(9)
(i) Unit 4 encompasses approximately 8 acres (3 hectares) and includes the entirety of Dog Island. Dog Island is approximately 1 mile (1.6 kilometers) to the east of Cedar Key within the Gulf of Mexico. Lands within this unit are entirely within State ownership.
(ii) Map of Unit 4 is provided at paragraph (8)(ii) of this entry.
(10)
(i) Unit 5 encompasses approximately 183 acres (74 hectares) and includes the entire island of Atsena Otie Key. Lands within this unit include approximately 116 acres (47 hectares) in State ownership and 67 acres (27 hectares) in other ownership. Atsena Otie Key is approximately 1 mile (1.6 kilometers) south of Cedar Key within the Gulf of Mexico. The island is owned by the State of Florida and managed as part of the Cedar Keys National Wildlife Refuge through a memorandum of understanding by the Service.
(ii) Map of Units 5, 6, and 7 follows:
(11)
(i) Unit 6 encompasses approximately 57 acres (23 hectares) and includes the
(ii) Map of Unit 6 is provided at paragraph (10)(ii) of this entry.
(12)
(i) Unit 7 encompasses approximately 165 acres (67 hectares) and includes the entire island of Seahorse Key. Lands within this unit include approximately 118 acres (48 hectares) in Federal ownership and 47 acres (19 hectares) in other ownership. Seahorse Key is approximately 3 miles (5 kilometers) south and west of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Cedar Keys National Wildlife Refuge.
(ii) Map of Unit 7 is provided at paragraph (10)(ii) of this entry.
(13)
(i) Unit 8 encompasses approximately 236 acres (95 hectares) and includes the entire island of North Key. Lands within this unit include approximately 129 acres (52 hectares) in Federal ownership and 107 acres (43 hectares) in other ownership. North Key is approximately 3 miles (4.8 kilometers) to the west of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Cedar Keys National Wildlife Refuge.
(ii) Map of Unit 8 follows:
(14)
(i) Unit 9 encompasses approximately 29 acres (12 hectares) on the island of Way Key. Lands within this unit include approximately 19 acres (8 hectares) in local government ownership and 10 acres (4 hectares) in private ownership. This unit is composed of five separate sections.
(A) Airstrip Island Beach is 5 acres (2 hectares) of private shoreline along Daughtry Bayou, encompassing sandy beach from mean higher high-water inland to dense vegetation, hardened structures, or roads, extending from the southern side of the Airport Road bridge to the south for approximately 0.5 mile (0.8 kilometer).
(B) Cedar Key Airport includes 16 acres (6.5 hectares) of unvegetated and vegetated sandy soils on the George T. Lewis Airport (also known as the Cedar Key Airport) that are owned by Levy County.
(C) Airport Island is a 2-acre (0.8-hectare), unnamed island southwest of the airport that is owned by Levy County.
(D) Piney Point is a 3-acre (1-hectare), privately owned, undeveloped, vacant lot on the western side of Piney Point south of the airport.
(E) The Robert Cull Nature Preserve is 2 acres (0.8 hectare) of protected land at the terminus of Piney Point that are owned and managed by Florida's Nature Coast Conservancy.
(ii) Map of Units 9 and 10 follows:
(15)
(i) Unit 10 encompasses approximately 44 acres (18 hectares) on Way Key. This unit is a series of undeveloped, disconnected islands south of Way Key. The unit includes a large portion of the island located between the airport and the developed portion of Way Key and several
(ii) Map of Unit 10 is provided at paragraph (14)(ii) of this entry.
(16)
(i) Unit 11 encompasses approximately 24 acres (10 hectares) on Way Key. Lands within this unit include approximately 9 acres (4 hectares) in State ownership, managed as the Cedar Key Museum State Park by the Florida Park Service, and 15 acres (6 hectares) in local government ownership, managed as Cemetery Point Park by the City of Cedar Key.
(ii) Map of Unit 11 follows:
(17)
(i) Unit 12 encompasses approximately 105 acres (42 hectares) and includes the entirety of Richards Island. Lands within this unit include approximately 86 acres (35 hectares) in Federal ownership and 19 acres (8 hectares) in other ownership. Richards Island is approximately 3.3 miles (5.3 kilometers) northwest of Cedar Key within the Gulf of Mexico. The island is managed by the Service as part of the Cedar Keys National Wildlife Refuge.
(ii) Map of Units 12 and 13 follows:
(18)
(i) Unit 13 encompasses approximately 136 acres (55 hectares)
(ii) Map of Unit 13 is provided at paragraph (17)(ii) of this entry.
(19)
(i) Unit 14 encompasses approximately 1,050 acres (425 hectares) on Shell Mound. This unit extends from Dennis Creek north to Ericson Creek. Lands within this unit include approximately 167 acres (68 hectares) in Federal ownership, 194 acres (79 hectares) in State ownership, and 688 acres (278 hectares) in private ownership. The unit includes portions of the Cedar Key Scrub State Reserve managed by the Florida Park Service and the Lower Suwannee National Wildlife Refuge managed by the Service.
(ii) Map of Units 14, 15, 16, and 17 follows:
(20)
(i) Unit 15 encompasses approximately 176 acres (71 hectares) on Raleigh and Horse Islands. Approximately 171 acres (69 hectares) are in Federal ownership and 5 acres (2 hectares) are in private ownership. The group of islands are approximately 6 miles (10 kilometers) northwest of Cedar Key within the Gulf of Mexico. The Service manages most of the islands as part of the Lower Suwannee National Wildlife Refuge.
(ii) Map of Unit 15 is provided at paragraph (19)(ii) of this entry.
(21)
(i) Unit 16 encompasses approximately 113 acres (46 hectares) and includes the entirety of Deer Island. Lands within the unit include approximately 8 acres (3 hectares) in Federal ownership, 69 acres (28 hectares) in private ownership, and 36 acres (15 hectares) in other ownership. Deer Island is approximately 7 miles (11 kilometers) northwest of Cedar Key within the Gulf of Mexico.
(ii) Map of Unit 16 is provided at paragraph (19)(ii) of this entry.
(22)
(i) Unit 17 encompasses approximately 121 acres (49 hectares) in the Clark Islands complex. The entirety of the unit is privately owned. The Clark Islands are approximately 7 miles (11 kilometers) north-northwest of Cedar Key within the Gulf of Mexico.
(ii) Map of Unit 17 is provided at paragraph (19)(ii) of this entry.