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Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D
This rule is effective January 5, 2023. The incorporation by reference of certain material listed in the rule is approved by the Director of the Federal Register as of January 5, 2023. See section VIII for further information on the filing of objections. Either electronic or written objections and requests for a hearing on the final rule must be submitted by February 6, 2023.
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The
Submit electronic objections in the following way:
•
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of objections. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Lane A. Highbarger, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1204, or Joan Rothenberg, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
In the
Vitamin D is essential for human health. The major function of vitamin D is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism, such as rickets in children or osteomalacia in adults. At high levels in the diet, vitamin D may be toxic. Excessive intake of vitamin D elevates blood plasma calcium levels (hypercalcemia) by increased intestinal absorption and/or mobilization from the bone, and possibly associated with decreased renal function and increased cardiovascular risk (Refs. 1 and 2).
To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, FDA affirmed vitamin D as generally recognized as safe (GRAS) with specific limitations as listed in § 184.1950 (21 CFR 184.1950). Under § 184.1(b)(2) (21 CFR 184.1(b)(2)), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use of the ingredient, and level of use. Any addition of vitamin D to food beyond those limitations set out in § 184.1950 requires a food additive regulation.
Vitamin D comprises a group of fat-soluble seco-sterols and occurs in many forms. The two major physiologically relevant forms are vitamin D
Vitamin D is also affirmed as GRAS under § 184.1950(c)(2) and (3) for use in infant formula and margarine, respectively. Vitamin D
To support their petition, Kellogg submitted dietary exposure estimates of vitamin D from the proposed uses of vitamin D
To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the additive, the additive's toxicological data, and other relevant information (such as published scientific literature) available to us. We compare the dietary exposure for the additive from all food sources to an acceptable intake level established by data. The dietary exposure is determined based on the amount of the additive proposed for specific uses in foods and on data regarding the amount consumed from all food sources of the additive. We commonly use the dietary exposure for the 90th percentile consumer of a food additive as a measure of high chronic dietary exposure (Ref. 3).
In 2011, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at the IOM conducted an extensive review of relevant published scientific literature to update established dietary reference intakes (DRI) for vitamin D; these DRIs are a family of nutrient reference values that
The IOM considers the UL as the maximum daily intake level of a nutrient that is likely to pose no health hazard risk for almost all individuals in the general population when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment approach developed specifically for nutrients. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: no-observed-adverse-effect level, lowest-observed-effect level, and application of an uncertainty factor. We considered the ULs established by the IOM relative to the cumulative dietary exposure estimates as the primary basis for assessing the safety of the petitioned uses of vitamin D
Kellogg provided mean and 90th percentile eaters-only dietary exposure estimates for vitamin D for the overall U.S. population and eight population subgroups from the: (1) proposed uses of vitamin D
Kellogg presented the dietary exposure estimates to vitamin D from the proposed and existing uses. However, Kellogg did not provide an overall dietary exposure from all proposed uses, but instead provided separate dietary exposures for each of the petitioned uses of vitamin D
FDA performed the dietary exposure estimate for vitamin D
For the overall U.S. population 1 year of age and older, we estimated the cumulative dietary exposure at the 90th percentile from all food sources of vitamin D, including the proposed uses and background sources, to be 2,730 IU/p/d. Additionally, the estimated 90th percentile dietary exposure to vitamin D from all food sources for infants 6 to 12 months of age is 1,060 IU/p/d. In summary, the cumulative dietary exposure to vitamin D
We reviewed and evaluated the information submitted by Kellogg regarding the safety of the dietary exposure to vitamin D
We reviewed the published reports of scientific studies on vitamin D submitted by Kellogg, as well as other relevant published studies available to us since our previous evaluations of food additive petitions for fortifying a variety of foods with vitamin D (85 FR 41916, July 13, 2020; 81 FR 46578, July 18, 2016; 79 FR 46993, August 12, 2014; 77 FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70 FR 69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, June 22, 2005; 68 FR 9000, February 27, 2003). These studies did not raise any new safety concerns regarding the current or proposed uses of vitamin D. The most recent food additive petition for a new use of vitamin D resulted in our amendment of the food additive regulations in § 172.382 to allow for the safe use of vitamin D
We consider the ULs established by the IOM relative to the dietary exposure estimates as the primary basis for assessing the safety of the petitioned uses of vitamin D
Because the estimated 90th percentile dietary exposure to vitamin D from all current and proposed food uses for each population group is less than the corresponding IOM UL for that population group, we conclude that dietary exposure to vitamin D
Based on the relevant data available to FDA and information in the petition, we conclude that there is a reasonable certainty that no harm will result from the use of vitamin D
FDA is incorporating by reference the monograph for vitamin D
The FCC monograph sets forth a standard for purity and identity for vitamin D
In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see
We previously considered the environmental effects of this rule, as stated in the August 12, 2019,
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348). This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) through (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act.
The following references marked with an asterisk (*) are on display in the Dockets Management Staff (see
Food additives, Incorporation by reference, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 172 is amended as follows:
21 U.S.C. 321, 341, 342, 348, 371, 379e.
(b) Vitamin D
(c) * * *
(9) At levels not to exceed 560 IU per 100 g in breakfast cereals (as defined under § 170.3(n)(4) of this chapter).
(10) At levels not to exceed 400 IU per 100 g in grain-based bars (
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, Agency, or we) is classifying brain stimulation programming planning software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain stimulation programming planning software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective January 5, 2023. The classification was applicable on August 23, 2021.
Kristen Bowsher, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD, 20993-0002, 301-796-6448,
Upon request, FDA has classified the brain stimulation programming planning software as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On February 3, 2021, FDA received Medtronic Neuromodulation's request for De Novo classification of the SureTune4 Software. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on August 23, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 882.5855.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
At the time of classification, brain stimulation programming planning software is for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Software verification, validation, and hazard analysis must be performed.
(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface components.
(iv) A warning regarding use of the data with respect to not replacing clinical judgment.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, Agency or we) is classifying the implantable post-surgical kinematic measurement knee device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the implantable post-surgical kinematic measurement knee device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective January 5, 2023. The classification was applicable on August 27, 2021.
Patrick Macatangga, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1567, Silver Spring, MD 20993-0002, 301-796-4369,
Upon request, FDA has classified the implantable post-surgical kinematic measurement knee device as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On October 19, 2020, FDA received Canary Medical, Inc.'s request for De Novo classification of the Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on August 27, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 888.3600.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801, regarding labeling, have been
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be conducted:
(i) Mechanical testing must evaluate the mechanical function (mechanical fatigue, static mechanical strength) and durability of the implant.
(ii) Simulated use testing must evaluate the ability of the device to be sized, inserted, and sufficiently secured to any compatible components.
(iii) Testing must demonstrate the accuracy, reliability, and reproducibility of kinematic measurements.
(iv) Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use.
(v) Testing must demonstrate that the device performs as intended under anticipated conditions of use demonstrating the following performance characteristics, if applicable:
(A) Magnetic pulse output testing;
(B) Magnetic and electrical field testing; and
(C) Testing of the safety features built into the device.
(vi) Testing must demonstrate hermeticity of any electronic component enclosures.
(2) Performance testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including for implantation and post-procedure data access.
(4) Performance data must demonstrate the sterility of the device implant and patient-contacting components.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) The patient-contacting components of the device must be demonstrated to be biocompatible.
(7) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(8) Performance testing must demonstrate the electromagnetic compatibility/interference, (EMC/EMI), electrical safety, thermal safety, battery safety, and wireless performance of the device.
(9) Software verification, validation, and hazard analysis must be performed.
(10) The labeling must include the following:
(i) A shelf life;
(ii) Physician and patient instructions for use, including images that demonstrate how to interact with the device;
(iii) Detailed instruction of the surgical technique;
(iv) Hardware and software requirements for interacting with the device;
(v) A clear description of the technological features of the device including identification of the device materials, compatible components, and the principles of operation;
(vi) Identification of magnetic resonance (MR) compatibility status;
(vii) Validated methods and instructions for reprocessing of any reusable components; and
(viii) A statement regarding the limitations of the clinical significance of the kinematic data.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA, Agency, or we) is classifying the bone indentation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the bone indentation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective January 5, 2023. The classification was applicable on August 19, 2021.
Laura Rose, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4435, Silver Spring, MD 20993-0002, 301-348-1947,
Upon request, FDA has classified the bone indentation device as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On March 31, 2021, FDA received Active Life Scientific's request for De Novo classification of the OsteoProbe. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on August 19, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 888.1600.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance testing must demonstrate:
(i) The sterility of the patient-contacting components of the device; and
(ii) Validation of reprocessing instructions for any reusable components of the device.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(9) Labeling must include:
(i) Instructions for use;
(ii) Validated methods and instructions for reprocessing of any reusable components;
(iii) A shelf life for any sterile components;
(iv) Information regarding limitations of the clinical significance of the device output; and
(v) A detailed summary of the accuracy and precision of the device.
Internal Revenue Service (IRS), Treasury.
Final regulations; correction.
This document contains corrections to final regulations (TD 9969) that was published in the
These corrections are effective on January 5, 2023, and are applicable on December 9, 2022.
Concerning the final regulations, Jennifer M. Black, at (202)317-6834 (not a toll-free number).
The final regulations (TD 9969) subject to this correction are under section 6241(11) and 6241(7) of the Internal Revenue Code.
Accordingly, the final regulations (TD 9969) that are the subject of FR Doc. 2022-26783, published on December 9, 2022, at 87 FR 75473, are corrected to read as follows:
1. On page 75474, in the second column, the fifteenth line from the top of the first full paragraph, the language “of partner” is removed.
2. On page 75474, in the second column, the nineteenth line from the top of the first full paragraph is corrected to read “additional example of an ineligible partner”.
3. On page 75476, in the first column, the last sentence of the first partial paragraph, the language “adjustment-year” is corrected to read “adjustment year” wherever it appears.
4. On page 75482, in the third column, the twelfth line from the bottom of the first full paragraph, the language “partner level” is corrected to read “partner-level”.
5. On page 75486, in the first column, in the seventh line from the bottom of the second full paragraph, the language “easily” is removed.
6. On page 75486, in the second column, in the third line from the bottom of the second full paragraph, the language “not” is removed.
Internal Revenue Service (IRS), Treasury.
Final rule; correcting amendments.
This document contains corrections to a final regulation (TD 9969) that was published in the
Concerning the regulations, Jennifer M. Black, at (202) 317-6834 (not a toll-free number).
The final regulations (TD 9969) that are the subject of these corrections are under section 6241(11) and 6241(7) of the Internal Revenue Code.
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting, and recordkeeping requirements.
Accordingly, 26 CFR part 301 is corrected by making the following correcting amendments:
26 U.S.C. 7805.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Corpus Christi Shipping Channel in a zone defined by the following coordinates; 27°50′31.28″ N, 97°04′17.23″ W; 27°50′31.73″ N, 97°04′15.44″ W; 27°50′29.06″ N, 97°04′16.61″ W; 27°50′29.32″ N, 97°04′14.82″ W. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by pipelines that will be removed from the floor of the Corpus Christi Shipping Channel. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Corpus Christi or a designated representative.
This rule is effective without actual notice from January 5, 2023, through 4 a.m. on January 9, 2023. For the purposes of enforcement, actual notice will be used from 8 p.m. on January 3, 2023, until January 5, 2023.
If you have questions on this rule, call or email Lieutenant Commander Anthony Garofalo, Sector Corpus Christi Waterways Management Division, U.S. Coast Guard; telephone 361-939-5130, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This 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.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone immediately to protect personnel, vessels, and the marine environment from potential hazards created by pipeline removal operations and lack sufficient time to provide a reasonable comment period and then to consider those comments before issuing the rule.
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 Corpus Christi (COTP) has determined that potential hazards associated with pipeline removal operations occurring from 8 p.m. on January 3, 2023, through 4 a.m. on January 9, 2023, will be a safety concern for anyone within the Corpus Christi Shipping Channel in a zone defined by the following coordinates; 27°50′31.28″ N, 97°04′17.23″ W; 27°50′31.73″ N, 97°04′15.44″ W; 27°50′29.06″ N, 97°04′16.61″ W; 27°50′29.32″ N, 97°04′14.82″ W. The purpose of this rule is to ensure safety of vessels and persons on these navigable waters in the safety zone while pipelines are removed from the floor of the Corpus Christi Shipping Channel.
This rule establishes a temporary safety zone from 8 p.m. on January 3,
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 Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the size, location, and duration of the safety zone. The temporary safety zone will be enforced for a short period of only 8 hours each day. The rule does not completely restrict the traffic within a waterway and allows mariners to request 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 temporary 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 contact 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 about this rule or any policy or action of the Coast Guard.
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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
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, 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 establishment of a temporary safety zone for navigable waters of the Corpus Christi Shipping Channel in a zone defined by the following coordinates; 27°50′31.28″ N, 97°04′17.23″ W; 27°50′31.73″ N, 97°04′15.44″ W; 27°50′29.06″ N, 97°04′16.61″ W; 27°50′29.32″ N, 97°04′14.82″ W. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by pipeline that will be removed from the floor of the Corpus Christi Shipping Channel. It is categorically excluded from further review under paragraph L60(d) Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. 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 contact 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) If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
(d)
Postal Service
Final rule.
The Postal Service
Effective January 22, 2023.
Dale Kennedy at (202) 268-6592 or Doriane Harley at (202) 268-2537.
As part of its network redesign efforts, the Postal Service is eliminating the use of sacks as containers for Flats acceptance/entry but will continue to allow Flat trays as acceptable containers for acceptance and entry along with bundles on pallets for USPS Marketing Mail and Periodicals flat Mail. Carrier route, 5-digit scheme carrier routes and 5-digit carrier routes USPS Marketing Mail® and Periodicals flat mail will continue to be allowed to use sacks as a handling unit.
The Postal Service received seven formal comments on the October 21, 2022, proposed rule (87 FR 63985). Two commenters supported the proposed rule, and five cited concerns:
The Postal Service adopts the following changes to
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.
Administrative practice and procedure, Postal Service.
Accordingly, 39 CFR part 111 is amended as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
[Revise the title of 4.4 to read as follows:]
b. Bundles placed in or on 5-digit or 5-digit scheme (L001) flat trays or pallets.
c. Bundles placed in carrier route and 5-digit carrier routes flat trays or sacks.
In addition to following the standards in 4.5 through 4.7, mailers must prepare bundles placed in flat trays and sacks as follows:
Mailers may enter unsacked, untrayed, or nonpalletized bundles of carrier route, Periodicals, or USPS Marketing Mail flats and unsacked bundles of Bound Printed Matter (BPM) flats or irregular parcels (BPM only) at destination delivery units (DDUs) if all the following conditions are met:
* * * Bundles must be secure and stable subject to weight limits in 705.8.0 if placed on pallets, and weight and height limits in 4.8 if placed in flat trays.
* * * Periodicals and USPS Marketing Mail flat-size mailings must be prepared in flat trays with white lids under 207.22.7, 207.25.5, 245.8.7, and 245.10.4.3 and strapped under 5.6.2e.
c. Flat trays used in a Periodicals or USPS Marketing Mail flat-size mailing
e. Each tray must be covered (with the green side of the lid facing up for First Class mail and the white side facing up for Periodicals and USPS Marketing Mail). Each covered flat tray must then be secured with two plastic straps placed tightly around the width of the tray (the shorter dimension).
* * * Bundle prices do not apply to barcoded letter-size mail prepared in full letter trays.***
2. Bundles in carrier route, 5-digit scheme carrier routes, 5-digit carrier routes sacks/flat trays, or 3-digit carrier routes flat trays under 23.0. Sacks/flat trays may be palletized under 705.8.0.
3. Unsacked/untrayed bundles entered at a destination delivery unit under 23.4.2 and 29.6.5.
j. A
s. An
y. A
Mailings must be prepared in letter trays (letters), flat trays (flats) under 22.7 and 25.5, or sacks (carrier route, 5-digit scheme cr-rt and 5-digit cr-rt flats, or 5-digit flats entered at a DDU, 3-digit/SCF destination SCF flats, and all periodicals parcels).* * *
* * * Firm bundles must not be placed in 5-digit scheme flat trays.
a. Place bundles in only 5-digit, 3-digit, and SCF flat trays that contain at least 24 pieces, or in origin/entry SCF flat trays, as appropriate.
For mailing jobs that also contain a barcoded mailing, see
a.
1. Line 1: use city, state, and 5-digit ZIP Code on mail (see
2. Line 2: “PER” or NEWS” as applicable; followed by “IRREG” as applicable; followed by “5D”.
b.
1. Line 1: use
2. Line 2: “PER” or “NEWS” as applicable; followed by “IRREG” as applicable; followed by “3D'.
c.
1. Line 1: use
2. Line 2: “PER” or “NEWS” as applicable; followed by “IRREG” as applicable; followed by “SCF'.
d.
1. Line 1: use
2. Line 2: “PER” or “NEWS” as applicable; followed by “IRREG” as applicable; followed by “SCF'.
e.
1. Line 1: use
2. Line 2: “PER” or “NEWS” as applicable; followed by or “IRREG” as applicable; followed by “ADC'.
f.
1. Line 1: Use
2. Line 2: “PER” or “NEWS” as applicable, followed by “IRREG” as applicable, followed by “WKG W FCM.”
g.
1. Line 1: Use
2. Line 2: “PER” or “NEWS” as applicable; followed by “IRREG” as applicable; followed by “WKG” for irregular parcels.
Mailers must place flat sized pieces in flat trays (see 203.5.6) instead of sacks unless prepared as direct carrier route, 5-digit scheme carrier route, or 5-digit carrier route (see 23.4.1
a. Place bundles in only 5-digit scheme carrier routes and 5-digit carrier routes sacks/flat trays that contain at least 24 pieces, or 3-digit carrier routes or merged 3-digit flat trays that contain at least one six-piece carrier route bundle.
e. Place bundles in existing carrier-route flat trays, 5-Digit scheme carrier routes, or 5-Digit carrier routes sacks/flat trays.
b. Mailing jobs prepared entirely in flat trays and qualifying for this exception must be cobundled under 705.11.0.
c. As an alternative to 705.9.0 through 705.13.0, if a portion of the job is prepared as palletized barcoded flats, the nonbarcoded portion may be prepared as palletized flats and paid for at nonbarcoded machinable and carrier route prices. The nonbarcoded price pieces that cannot be placed on ADC or finer pallets may be prepared as flats in flat trays and paid at the nonbarcoded prices.
a. Place 5-digit and 3-digit bundles in only 5-digit scheme, 5-digit, 3-digit, and SCF flat trays, as appropriate, that contain at least 24 pieces, or in merged 3-digit flat trays that contain at least one six-piece carrier route bundle, or in origin/entry SCF flat trays.
c. Place 5-digit scheme and 3-digit scheme bundles in only 5-digit scheme, 3-digit, and SCF flat trays, as appropriate, that contain at least 24 pieces, or in merged 3-digit flat trays that contain at least one six-piece carrier route bundle, or in origin/entry SCF flat trays.
b. If the mailing job contains a machinable barcoded and nonbarcoded mailing, then it must be prepared under the cotraying standards in 705.9.0. Machinable barcoded and nonbarcoded pieces may be cobundled under the standards in 705.11.0.
c. If the mailing job contains a carrier route mailing and a machinable barcoded mailing, then it must be separately trayed under 23.0 and 25.0 or prepared using the merged flat tray option under 705.10.0.
a. In a 5-digit/scheme bundle of 10 or more pieces, or 15 or more pieces, as applicable; properly placed in a 5-digit/scheme flat tray (see full flat tray 245.1.4).
c. In a 5-digit bundle of 10 or more pieces, or 15 or more pieces, as applicable; properly placed in a merged 5-digit/scheme or 5-digit flat tray under 705.10.0.
a. In a 5-digit/scheme bundle of 10 or more pieces, or 15 or more pieces, as applicable, or in a 3-digit/scheme bundle of 10 or more pieces; properly placed in a 3-digit flat tray (see full flat tray 245.1.4).
a. In a 5-digit/scheme, 3-digit/scheme, or ADC bundle of 10 or more pieces properly placed in an ADC flat tray (see full flat tray 245.1.4).
b. In an optional 3-digit/scheme origin/entry flat tray.
Mixed ADC prices apply to flat-size pieces in bundles that do not qualify for 5-digit, 3-digit, or ADC prices; placed in mixed ADC flat trays or on ASF, NDC, or mixed NDC pallets under 705.8.0.
The Basic-CR Bundles/Container discount applies to each piece in a carrier route bundle of 10 or more pieces that are palletized under 705.8.0, 705.10.0, 705.12.0, or 705.13.0 on a 5-digit merged, 5-digit (scheme) merged, 5-digit carrier route or 5-digit scheme carrier route pallet entered at an Origin (None), DNDC, DSCF, or DDU entry or in a carrier route sack or flat tray under 245.9.7a or 203.5.8 and entered at the DDU.
The High Density-CR Bundles/Container discount applies to 125 or more High Density-eligible pieces that are palletized under 705.8.0, 705.10.0, 705.12.0, or 705.13.0 on a 5-digit merged, 5-digit (scheme) merged, 5-digit carrier route, 5-digit carrier routes, or 5-digit scheme carrier route pallet entered at an Origin (None), DNDC, DSCF, or DDU entry or in a carrier route sack or flat tray under 245.9.7a or 203.5.8 and entered at the DDU.
The High Density Plus-CR Bundles/Container discount applies to 300 or more High Density Plus-eligible pieces that are palletized under 705.8.0, 705.10.0, 705.12.0, or 705.13.0 on a 5-digit scheme, 5-digit (scheme) merged, 5-digit carrier route, 5-digit carrier routes, or 5-digit scheme carrier route
c. Placed in a merged 5-digit scheme or merged 5-digit flat tray.
d. Placed in a 5-digit scheme carrier routes or 5-digit carrier routes sack/flat tray.
c.
e.
g.
q.
e. A full flat tray is one that is physically full. Although a specific minimum volume is required (at least a single stack of mail lying flat on the bottom of the tray and filling the tray to the bottom of the handholds) before a tray may or must be prepared to the corresponding presort destination, trays must be filled with additional available pieces (up to the reasonable capacity of the tray) when standards require preparation of full trays.
f. A full sack is defined in the standards for the class and price claimed.
h.
k.
l.
m.
y. A
* * * Flat mailings must be prepared in flat trays or sacks (carrier route, 5-digit scheme carrier route and 5-digit carrier route only) except when permitted to be prepared in letter trays under other applicable standards in this section. * * *
2. Unless excepted by standard, all pieces must be in the flat-size processing category and must be prepared in flat trays or on pallets. Certain flat-size pieces may be prepared in letter trays under 3.0.
District managers may authorize loose packing of unbundled pieces in flat trays if no pieces in a flat tray would be more finely sorted if bundled. Pieces must be faced and packed to remain oriented in transit. Requests for loose packing must be made in advance through the Post Office of mailing.
Except as provided in 8.6, a flat tray, or a letter tray under 3.0, must be prepared when the quantity of mail for a required presort destination reaches a full flat tray (up to the handholds), subject to these conditions: * * *
2. The actual piece count or mail weight for each tray is used, if documentation can be provided with the mailing that shows for each tray the number of pieces and the total weight.
Preparation sequence, flat tray and labeling:
a. 5-digit/scheme (required); scheme sort required (before 5-digit sort), only for pieces meeting the automation flats criteria in 201.6.0, see definition in 1.4j; full flat tray; labeling: * * *
1. Line 1: For 5-digit scheme flat trays use L007, Column B. For 5-digit flat trays, use city, state, and 5-digit ZIP Code destination on pieces. (See 203.5.11 for overseas military mail).
2. Line 2: For 5-digit scheme flat trays, “STD FLT 5D SCH NON BC.” For 5-digit flat trays, “STD FLTS 5D NON BC.”
b. 3-digit (required); full flat tray; labeling: * * *
d. ADC (required); full flat tray; labeling: * * *
b. If the mailing job contains an automation mailing and a nonautomation mailing, then it must be prepared under the cotrayed standards in 705.9.0.
c. If the mailing job contains a carrier route mailing and a nonautomation mailing, then it must be separately sacked or trayed under 5.0 and 9.0 or prepared using the merged sacking/traying option in 705.10.0.
d. If the mailing job contains a carrier route mailing and an automation mailing, then it must be separately sacked or trayed under 9.0 and 10.0 or prepared using the merged sacking/traying option in 705.10.0.
Under the optional preparation in 705.10.0, nonautomation 5-digit bundles prepared under 5.2 through 8.8 are cotrayed with carrier route bundles prepared under 9.0 and with automation 5-digit bundles prepared under 10.0 in merged 5-digit scheme flat trays and merged 5-digit flat trays. Under the optional preparation in 705.10.0, 705.12.0, or 705.13.0, nonautomation 5-digit bundles are copalletized with carrier route bundles prepared under 9.0 and with automation 5-digit bundles prepared under 10.0 on merged 5-digit scheme pallets and merged 5-digit pallets. See 8.8a for information on when preparation under 705.10.0 may be required.
Mailers entering USPS Marketing Mail residual pieces that do not qualify for USPS Marketing Mail prices, and paying the First-Class Mail prices (but prepared “as is” under 244.5.0), must separately bundle and flat tray residual pieces from the automation and presort pieces. Mailers must label flat trays under 204.3.0 using the CIN code 582 for use with residual flat trays. Label flat trays as follows: * * *
When traying/sacking is required, mailers must prepare a flat tray/sack when the quantity of mail for a required presort destination reaches either up to the handholds (see full flat tray 245.1.4),
c. Less than full flat trays (see 245.1.4) and sacks with fewer than 125 pieces or less than 15 pounds of pieces may be prepared to a carrier route when the saturation price is claimed for the contents and the applicable density standard is met.
Under the optional preparation in 705.10.0, carrier route price bundles prepared under 9.3 and 9.4 are cotrayed with Presorted price 5-digit bundles prepared under 8.0 and with automation price 5-digit bundles prepared under 10.0 in merged 5-digit scheme flat trays and merged 5-digit flat trays. * * *
* * * Flat trays must bear the appropriate barcoded container labels under 4.0.
A flat tray or a letter tray under 3.0, must be prepared when the quantity of mail for a required presort destination reaches either a full flat tray (1.4e), 125 pieces, or 15 pounds of pieces, whichever occurs first, subject to these conditions:
b. For nonidentical-weight pieces, mailers must either use the minimum that applies to the average piece weight for the entire mailing (divide the net weight of the mailing by the number of pieces; the resulting average single-piece weight determines whether the 125-piece or 15-pound minimum applies) or tray by the actual piece count or mail weight for each flat tray, if documentation can be provided with the mailing that shows (specifically for each flat tray) the number of pieces and their total weight.
Preparation sequence, flat tray size, and labeling:
a. 5-digit/scheme (required); scheme sort required before 5-digit sort; see definition in 1.4g.; full flat tray, 125-piece, or 15-pound minimum, labeling:
1. Line 1: For 5-digit scheme flat trays use L007, Column B. For 5-digit flat trays use city, state, and 5-digit ZIP Code on mail (see 203.5.11 for overseas military mail).
2. Line 2: For 5-digit scheme flat trays, “STD FLTS 5D SCH BC.” For 5-digit flat trays, “STD FLTS 5D BC.”
b. 3-digit (required); full flat tray, 125-piece, or 15-pound minimum; labeling: * * *
d. ADC (required); full flat tray, 125-piece, or 15-pound minimum; labeling:
Mailers must prepare letter-size pieces in trays. Mailers must prepare flat-size pieces in carrier route bundles in sacks, flat trays, or directly on pallets. Mailers must prepare irregular parcels in carrier route bundles in sacks or directly on pallets. Bundles, sacks, or trays may be placed on SCF, 3-digit, 5-digit, or 5-digit scheme pallets under 705.8.10. In addition to the required simplified address, each bundle must bear a facing slip showing the desired distribution (for example, 5-digit ZIP Code and route number) or the top piece of each bundle must include the route number and ZIP Code. Mailers may obtain delivery statistics for routes as described in 509.1.0. The following also applies: * * *
1. In a single mailing, the minimum load per pallet is 250 pounds of bundles, parcels, or sacks, except as provided in items 2 through 4 below. When preparing letter trays on pallets, the minimum load is 36 linear feet or three layers of trays, except as provided in items 2 and 4 below. When preparing flat trays on pallets, the minimum load is 24 linear feet or three layers of flat trays, except as provided in items 2 and 4 below.
6. There is no minimum load for MNDC pallets of bundles or flat trays of USPS Marketing Mail flats.
f.
h.
i. ADC, required, permitted for bundles, trays, and sacks (irregular parcels only). Pallet may contain carrier route, automation price, and/or Presorted price mail for the 3-digit ZIP Code groups in L004. Labeling: * * *
j.
k. Mixed ADC, optional for sacks (irregular parcels only) and trays; allowed with no minimum and required at 100 pounds of mail for bundles of flats. Bundles of flats totaling less than 100 pounds in weight must be trayed if not palletized. Pallet may contain carrier route, automation price, or presorted price mail. Pallets must not contain sacks, trays or bundles that should be properly placed on the origin mixed ADC (OMX) pallet. Labeling: * * *
d. 5-digit, required except for trays, permitted for bundles, trays, and sacks (irregular parcels only). Pallet must contain only automation price and/or Presorted price mail for the same 5-digit ZIP Code or same 5-digit scheme. 5-digit scheme bundles and trays are assigned to 5-digit pallets according to the “label to” 5-digit ZIP Code. Labeling: * * *
f. SCF, required, permitted for bundles, trays, and sacks (irregular parcels only). Pallet may contain carrier route, automation price, and/or Presorted price mail for the 3-digit ZIP Code groups in L005, or L051 for Parcel Select Lightweight sacks. Mailers may, at their option, place AADC trays on SCF pallets when the tray`s “label to” 3-digit ZIP Code (from L801) is within that SCF's service area. Mailers may also, at their option, place mixed ADC or mixed AADC trays, labeled per L010, on an SCF pallet entered at the SCF facility responsible for the processing of mixed ADC or mixed AADC trays for that NDC/ASF facility. The SCF Pallet discount applies to 3-Digit, ADC, 5-Digit, Carrier Route, High Density, High Density Plus, Saturation (including EDDM—Not Retail) USPS Marketing Mail flat shaped pieces on a SCF pallet entered at an Origin (None), DNDC, or DSCF entry. SCF pallet discount does not apply to Marketing Mail letters or parcels. Labeling: * * *
g.
h.
i. Mixed NDC, optional, permitted for bundles, trays, and sacks (irregular parcels only); allowed with no minimum and required at 100 pounds of mail for bundles of flats. Bundles of flats totaling less than 100 pounds in weight must be trayed if not palletized. Pallet may contain carrier route, automation, and/or Presorted mail. Mailers must place trays and sacks (irregular parcels only) containing pieces paid at the single-piece price on the mixed NDC pallet (unless required to be presented separately by special postage payment authorization). Labeling: * * *
d. If no single 5-digit level pallet within the SCF service area contains an adequate volume of mail to allow reallocation of a portion of the mail on a pallet as described in
b. If no single 5-digit level pallet within the SCF service area contains an adequate volume of mail to allow reallocation of a portion of the mail on a pallet as described in
Bundle reallocation to protect the ADC pallet is an optional preparation method authorized for mailers using
Bundles of flat-size pieces in a machinable barcoded (automation) price mailing must be cotrayed with bundles of flat-size pieces in a machinable nonbarcoded price mailing under the following conditions:
b. The machinable barcoded price mailing must meet the eligibility criteria in
c. The machinable nonbarcoded price mailing must meet the eligibility criteria in
d. The bundles prepared from the machinable barcoded price mailing and the bundles prepared from the machinable nonbarcoded price mailing must be sorted into the same flat trays as described in
e. A complete, signed, appropriate postage statement(s), using the correct USPS form or an approved facsimile, must accompany each mailing job prepared under these procedures. In addition to the applicable postage statement, documentation produced by PAVE-certified software or standardized documentation under
f. Barcoded tray labels under
5-digit and 3-digit bundles prepared under
Allowed for 3-digit and SCF non-palletized sacks entered at the Destination SCF and 5-digit sacks entered at a DDU. Machinable barcoded price and machinable nonbarcoded price bundles must be presorted together into sacks (cosacked) in the sequence listed below. Sacks must be labeled using the following information for Lines 1 and 2 and
a.
1. Line 1: use
2. Line 2: “PER” or “NEWS” as applicable and “FLTS 3D BC/NBC.”
b.
1. Line 1: use
2. Line 2: “PER” or “NEWS” as applicable and “FLTS SCF BC/NBC.”
See 207.20.0 for use of flat trays. Machinable pieces meeting the criteria in 201.6.0—Mailers must either bundle or group all pieces as specified in 207.25.0 and 207.22.0 for each 5-digit scheme, 5-digit, 3-digit scheme, 3-digit, SCF, and ADC destination. Bundling is not permitted unless it achieves a finer presort than the presort destination of the tray. The trays are subject to a container charge, and any bundles are subject to a bundle charge. Tray preparation, sequence, and labeling: * * *
Bundles of flats in an automation price mailing must be cotrayed with bundles of flats in a Presorted price mailing under the following conditions:
c. The automation price mailing must meet the eligibility criteria in
d. The Presorted price mailing must meet the eligibility criteria in
e. The prices for pieces in the automation price mailing are applied based on the number of pieces in the bundle and the level of bundle to which they are sorted under
f. The pieces must be marked according to
g. The bundles prepared from the automation price mailing and the bundles prepared from the Presorted price mailing must be sorted into the same flat trays as described in
h. A complete, signed postage statement(s), using the correct USPS form or an approved facsimile, must accompany each mailing job prepared under these procedures. In addition to the applicable postage statement, documentation produced by PAVE-certified software or standardized documentation under
i. Barcoded tray labels under
When a full flat tray is specified for a sortation level in
Presorted price and automation price bundles prepared under
a. 5-digit/scheme, required; scheme sort required, only for pieces meeting the automation-compatibility criteria in 201.6.0; full tray minimum; labeling:
1. Line 1: For 5-digit scheme flat trays, use
2. Line 2: For 5-digit scheme flat trays, “STD FLT 5D SCH BC/NBC”; for 5-digit flat trays, “STD FLT 5D BC/NBC.”
b. 3-digit, required, full flat tray minimum; labeling: * * *
d.
Carrier route bundles in a carrier route mailing may be placed in the same flat trays or on the same pallet as 5-digit bundles from machinable (barcoded or nonbarcoded) price mailings (including pieces cobundled under
a. A carrier route mailing must be part of the mailing job, unless cobundled under
c. Pieces in the machinable price mailing must meet the flats criteria in
e. Carrier route bundles may be cotrayed or copalletized with machinable barcoded price 5-digit bundles, machinable nonbarcoded price 5-digit bundles, and cobundled 5-digit bundles only for those 5-digit ZIP Codes that have an “A” or “C” indicator in the Carrier Route Indicators field in the City State Product indicating eligibility for such cotraying or copalletization. Containers of mail sorted in this manner are called “merged 5-digit” flat trays or pallets. Containers of mail sorted in this manner for which scheme (
f. If sortation under this section is performed, merged 5-digit flat trays or pallets must be prepared for all 5-digit ZIP Codes with an “A” or “C” indicator in the City State Product that permits such preparation when there is enough volume for the 5-digit ZIP Code to prepare such a flat tray under
g. For mailings prepared in flat trays, mailers may not combine firm bundles and 5-digit scheme pieces in 5-digit scheme bundles or in 5-digit scheme flat trays. Firm bundles must be placed in a separate individual 5-digit flat tray under
h. The bundles from each separated mailing must be sorted together into flat trays (cotrayed) under
i. A complete, signed postage statement(s), using the correct USPS form or an approved facsimile, must accompany each mailing job prepared under these procedures. In addition to the postage statement(s), documentation prepared by PAVE-certified software must be submitted with each cotrayed or copalletized mailing job that describes for each flat tray sortation level and flat tray, or each pallet sortation level and pallet, the number of pieces qualifying for each applicable price.
j. Barcoded tray labels under
Carrier route, 5-digit scheme, 5-digit, 3-digit scheme, and 3-digit bundles may contain fewer than six pieces when the publisher determines that such preparation improves service. Pieces in these low-volume bundles must be claimed at the applicable mixed ADC price (Outside-County) or basic price (In-County). Low-volume bundles are permitted only when they are sacked (as applicable), trayed, or prepared on pallets as follows:
1. Carrier route, merged 5-digit scheme, 5-digit scheme carrier routes, merged 5-digit, 5-digit carrier routes, 5-digit, 3-digit, and SCF sacks (5-digit scheme carrier routes and 5-digit carrier routes only) or flat trays that contain at least 24 pieces.
2. Merged 3-digit flat trays that contain at least one six-piece carrier route bundle.
3. Origin/entry SCF flat trays.
b. Place low-volume 5-digit scheme bundles in only 5-digit scheme, 3-digit, and SCF flat trays that contain at least 24 pieces, or in origin/entry SCF flat
All carrier route bundles must be placed in sacks/flat trays under
b.
h.
Carrier route bundles from a carrier route price mailing may be placed in the same flat tray or on the same pallet as 5-digit bundles from an automation price mailing and 5-digit bundles from a Presorted price mailing (including pieces cobundled under
a. A carrier route mailing must be part of the mailing job, unless cobundled under
e. Carrier route bundles may be cotrayed or copalletized with automation price 5-digit bundles, Presorted price 5-digit bundles, and cobundled 5-digit bundles only for those 5-digit ZIP Codes that have an “A” or “C” indicator in the Carrier Route Indicators field in the City State Product indicating eligibility for such cotraying or copalletization. Containers of mail sorted in this manner are called “merged 5-digit” flat trays or pallets. Containers of mail sorted in this manner for which scheme (
f. If sortation under this section is performed, merged 5-digit flat trays or pallets must be prepared for all 5-digit ZIP Codes with an “A” or “C” indicator in the City State Product that permits such preparation when there is enough volume for the 5-digit ZIP Code to prepare that flat tray or pallet.
g. For trayed mailings, the prices for pieces in the carrier route mailing are based on the criteria in
j. The bundles from each separate mailing must be sorted together into flat trays (cotrayed) under
l. In addition to the applicable postage statement, documentation produced by PAVE-certified software must be submitted with each cotrayed or copalletized mailing job that describes for each sack/flat tray sortation level and flat tray, or each pallet sortation level and pallet, the number of pieces qualifying for each applicable carrier route price, each applicable automation price, and each applicable Presorted price.
m. Barcoded tray labels under
When the minimum quantity of 125 pieces or 15 pounds of mail for sacks or a full flat tray is specified for a sortation level in
Mailers must prepare sacks and flat trays in the following manner and sequence. All carrier route bundles must be placed in sacks or flat trays under
b.
d.
h.
j. Mixed NDC, use 8.10.3h, as applicable, to prepare and label Mixed NDC pallets. * * * * *
* * * Mailing jobs (for flats meeting the criteria in
b. Mailings prepared in flat trays must meet the basic standards in
* * * Low-volume bundles are permitted only when they are trayed or prepared on pallets as follows:
a. Place low-volume 5-digit and 3-digit bundles in only 5-digit scheme, 5-digit, 3-digit, and SCF flat trays that contain at least 24 pieces; or in origin/entry SCF flat trays; or on merged 5-digit scheme, 5-digit scheme, merged 5-digit, 5-digit, 3-digit, or SCF pallets, as appropriate.
b. Place low-volume 5-digit scheme and 3-digit scheme bundles in only 5-digit scheme, 3-digit, and SCF flat trays that contain at least 24 pieces, or in origin/entry SCF flat trays, or on 3-digit or SCF pallets, as appropriate.
Mailers may choose to cobundle (see
b. Mailings prepared in flat trays must meet the basic standards in
g. Portions of the mailing job that cannot be palletized must be prepared in sacks/flat trays.
l. Portions of the mailing job that cannot be palletized must be prepared in flat trays.
j. Mixed NDC, use 8.10.3h, as applicable, to prepare and label Mixed NDC pallets.
h. Portions of the mailing job that cannot be palletized must be prepared in flat trays.
a. Portions of the mailing job that cannot be palletized must be prepared in flat trays.
j. Mixed NDC, use 8.10.3h, as applicable, to prepare and label Mixed NDC pallets
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing the approval of a State Implementation Plan (SIP) revision, submitted by North Carolina on April 13, 2021. Specifically, EPA is approving updates to the incorporation by reference of Federal new source review (NSR) regulations and federal guidelines on air quality modeling in the North Carolina SIP. EPA is also converting a previous conditional approval regarding the infrastructure SIP prevention of significant deterioration (PSD) elements, for the 2015 ozone national ambient air quality standards (NAAQS) for North Carolina to a full approval. EPA is also approving updates to North Carolina's NSR regulations to better align them with the federal rules. EPA is approving these changes pursuant to the Clean Air Act (CAA or Act).
This rule is effective February 6, 2023.
EPA has established a docket for this action under Docket ID No. EPA-R04-OAR-2022-0782. All documents in the docket are listed on the
Josue Ortiz Borrero, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number for Mr. Ortiz Borrero is (404) 562-8085. Mr. Ortiz Borrero can also be reached via electronic mail at
On October 1, 2015, EPA promulgated a revised primary and secondary NAAQS for ozone, revising the 8-hour ozone standards from 0.075 parts per million (ppm) to a new more protective level of 0.070 ppm.
On September 27, 2018, North Carolina met the requirement to submit an iSIP for the 2015 8-hour ozone NAAQS by the October 1, 2018, deadline. Through previous rulemakings, EPA approved most of the infrastructure SIP elements for the 2015 ozone NAAQS for North Carolina.
As discussed in the conditional approval for the 2015 ozone iSIP PSD elements, North Carolina's SIP contained outdated references to Appendix W, and the State committed to update the outdated references and submit a SIP revision within one year of EPA's final rule conditionally approving these PSD elements. Accordingly, North Carolina was required to make its submission by April 15, 2021. North Carolina met its commitment by submitting a SIP revision to correct the deficiencies on April 13, 2021.
Through a Notice of Proposed Rulemaking (NPRM), EPA proposed to approve the changes to the North Carolina SIP and to also convert the April 15, 2020, conditional approval to a full approval regarding element C, Prong 3, and element J for the 2015 8-hour ozone NAAQS infrastructure SIP.
In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of North Carolina regulations 15A NCAC 02D .0530, “Prevention of Significant Deterioration,” state effective on October 1, 2020, and .0544, “Prevention of Significant Deterioration Requirements for Greenhouse Gases,”
EPA is not approving the October 1, 2020, state-effective version of Rule 02D .0530 to the extent that the rule incorporates by reference 51.166(b)(2)(iii)(
EPA is also not approving the October 1, 2020, state-effective version of Rule 02D .0530 to the extent the rule incorporates by reference 40 CFR 51.166(i)(2). Instead, the version of 40 CFR 51.166(i)(2) in the SIP remains the version that existed in the CFR on July 1, 2014, as approved by EPA into the SIP on September 11, 2018 (83 FR 45827).
Finally, EPA is not approving the October 1, 2020, state-effective version of Rule 02D .0530 to the extent the rule incorporates by reference the following federal provisions: 40 CFR 51.166(b)(2)(v), 51.166(b)(3)(iii)(
EPA is approving changes to the North Carolina SIP and converting the conditional approval for element C, Prong 3, and element J for the 2015 8-hour ozone Infrastructure SIP to a full approval. Specifically, EPA is approving changes to North Carolina Rule 15A NCAC 02D .0530, “Prevention of Significant Deterioration,” and .0544, “Prevention of Significant Deterioration Requirements for Greenhouse Gases.”
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 6, 2023. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:
42 U.S.C. 7401
The additions read as follows:
(c) * * *
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA or Agency) is determining that the Las Vegas, Nevada nonattainment area (“Las Vegas”) failed to attain the 2015 ozone National Ambient Air Quality Standard (NAAQS) by the applicable attainment date. The effect of failing to attain by the applicable attainment date is that Las Vegas is being reclassified by operation of law as “Moderate” nonattainment for the 2015 ozone NAAQS on January 5, 2023, the effective date of this final rule. Accordingly, the Nevada Division of Environmental Protection (NDEP) must submit State Implementation Plan (SIP) revisions and implement controls to satisfy the statutory and regulatory requirements for Moderate areas for the 2015 ozone NAAQS according to the deadlines established in this final rule.
The effective date of this rule is January 5, 2023.
The EPA has established a public docket for this action at
Karina O'Connor, Air Planning Office (AIR-2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105; By
The following is an outline of the Preamble.
On July 22, 2022, the EPA proposed to determine that Las Vegas failed to attain the 2015 ozone NAAQS by the applicable attainment date and did not qualify for a 1-year attainment date extension. Under Clean Air Act (CAA or “Act”) section 181, the EPA has a statutory obligation to determine whether the Marginal nonattainment area attained the 2015 ozone NAAQS by August 3, 2021, the applicable attainment date.
In the July 2022 proposal, the EPA solicited comment on adjusting the due dates, in accordance with CAA section 182(i), for submission and implementation deadlines for all SIP requirements that apply to Las Vegas.
The EPA proposed to align the submission deadline for all Moderate area SIP elements for Las Vegas with the proposed January 1, 2023, deadline for other areas being reclassified from Marginal to Moderate in the EPA's national determination for Marginal areas under the 2015 ozone NAAQS.
The EPA's implementing regulations for the 2015 ozone NAAQS require that, for areas initially classified as Moderate or higher, a state shall provide for implementation of reasonable available control technology (RACT) as expeditiously as practicable but no later than January 1 of the fifth year after the effective date of designation, which corresponds with the beginning of the attainment year for initially classified Moderate areas (
A “Basic” vehicle inspection and maintenance program (I/M program) is required for all urbanized Moderate areas under the 2015 ozone NAAQS. The Las Vegas nonattainment area is currently operating I/M programs as part
The public comment period for the EPA's July 2022 proposal closed on August 22, 2022. The EPA requested comment on the determination of failure to attain and subsequent reclassification from Marginal to Moderate as well as the Moderate area SIP revision and implementation deadlines. The two comment letters received during this period can be found in the docket for this action. In the first letter, the Clark County DES disagrees with the EPA's proposed reclassification and the associated timelines for the SIP revision and implementation. In the second letter, Earthjustice, on behalf of Sierra Club, supports all aspects of the EPA's proposal but expresses a concern about review of wildfires under the Exceptional Events Rule (EER).
The EPA received adverse comments on its proposal to determine that Las Vegas failed to attain by the applicable attainment date and to reclassify the area as Moderate from the Clark County DES.
Under the EPA regulations at 40 CFR part 50, Appendix U, the 2015 ozone NAAQS is attained at a monitoring site when the three-year average of the annual fourth-highest daily maximum eight-hour average ozone concentration (
Of the seventeen EE demonstrations submitted by Clark County DES, the EPA first reviewed three wildfire events and two stratospheric ozone intrusion (SOI) events, based on the regulatory significance and critical potential effect on design values and 2020 data of these five events. As more fully discussed in the EE technical support documents included in the docket to this rulemaking, the EPA ultimately found that none of the five demonstrations fully satisfied all of the EER criteria required for the EPA to concur; specifically, the EPA determined that each of the five demonstrations did not sufficiently show a clear causal relationship between the specific events and the monitored exceedances. This conclusion was based on the technical review of extensive information presented in the demonstrations, such as meteorological data, fire and stratospheric ozone intrusion information and analyses, trajectory analysis, ground level monitoring data, and statistical modeling analysis. The technical data and analyses presented did not support that event emissions were transported to the Clark County
The EPA notified Clark County DES of its decision to nonconcur on the five demonstrations on April 11, 2022. As a result of the nonconcurrences on the five demonstrations, the remaining demonstrations submitted by Clark County DES, even if concurred upon, would not have resulted in an attaining DV or air quality that would have met the criterion for an attainment date extension. Therefore, the remaining EE demonstrations no longer had regulatory significance, as required by the 2016 EER, and were not reviewed by the EPA.
The EPA acknowledges the complexity and intricacies of regional conditions prevalent across the country and is committed to continuing to provide clarification and assistance to states as the EER is implemented and through communications between the Regions and the states to ensure that these regional conditions are adequately addressed. However, to the extent that the commenters suggest the EPA revisit the EER and EE guidance in this rulemaking, either to provide additional clarifications or because of a commenter's concern that implementation of the EER undermines attainment of the NAAQS, the EPA believes that doing so is beyond the scope of this rulemaking to determine whether Las Vegas attained by its Marginal area attainment date.
While we acknowledge that wildfires have become more common in the West, we reiterate that the EPA carefully examined Clark County DES' EE demonstrations, and, as described in more detail above and in the EE technical support documents included in the docket to this rulemaking, found that the EE demonstrations submitted by Clark County DES did not sufficiently establish a clear causal relationship between wildfire emissions and ozone concentrations during the three identified wildfire exceedance events reviewed by the EPA. The EPA's evaluation of the “clear causal relationship” criterion did not rely on the frequency of events, and therefore an increasing frequency or intensity of wildfires were not considered in the EPA's nonconcurrence determinations issued with respect to the Clark County DES wildfire demonstrations.
From an air quality perspective, the EPA has multiple Air Sensor Loan Programs to help bolster local air quality monitoring efforts. One example of this is the Wildfire Smoke Air Monitoring
Federal agencies will continue to engage on various fronts to address wildfires and the associated impacts, and the EPA will continue to incorporate the tools and research information to work with Clark County DES and others toward protecting the environment and human health.
The EPA received one supportive comment from the Sierra Club and adverse comments from Clark County DES on our proposed deadlines, which are addressed as follows. We acknowledge that meeting a January 1, 2023, SIP submission and RACM/RACT implementation deadline will be challenging. As discussed in our responses, the options for establishing deadlines within the CAA framework of attainment timeframes and RACT implementation requirements are constrained. We also note that a state may at any time request—and the EPA must grant—a voluntary reclassification under CAA section 181(b)(3). As a general matter, the EPA remains committed to working closely with affected states to help them prepare their SIP revisions in a timely manner. One additional comment, regarding future contingency measures policy is also addressed below.
The commenter disagrees with the EPA's exercise of discretion under CAA section 182(i) to provide for consistency among the required SIP submissions by harmonizing the SIP submission and RACT SIP implementation deadlines, claiming the EPA has not yet shown that its exercise of discretion is “necessary or appropriate” under the Act.
Further, the commenter requests that the EPA use its general regulatory authorities under CAA section 301(a)(1) to harmonize the SIP submission deadlines and the attainment date on the grounds that Congress intended for the EPA to give adequate time for states to implement control measures before facing sanctions or additional bump-ups. The commenter notes that the D.C. Circuit Court of Appeals has held that an agency's statutory interpretation must “avoid unnecessary hardship or surprise to affected parties and remains within the general statutory bounds prescribed.”
We note that first and foremost, the primary purpose of title I of the CAA and subpart 2 in particular is the expeditious attainment of the NAAQS in all areas. We do not agree that the Act provides support for the notion that the overriding goal of these statutory provisions is to provide adequate time to states for implementing control measures, or that our proposed SIP submission and implementation deadlines would result in “unnecessary hardship or surprise” that exceeds permissible bounds. The plain language of the CAA mandates that the Las Vegas area be reclassified as Moderate as a matter of law because the area failed to attain the NAAQS by its Marginal attainment date. The Act, and its implementing regulations, further mandate that, once reclassified, the area's new attainment date is August 3, 2024.
The State, in this case, has been on notice since December 2020 that there was a possibility that Las Vegas would be reclassified, given the preliminary air quality data for the time period relevant to attainment demonstrations (2018-2020). Moreover, the EPA shared with the State in April of this year that we did not agree with the state's exceptional events demonstrations, paving the way for a finding that the area did not attain and would be reclassified. A state need not wait until EPA's finding and reclassification is made effective before beginning to develop an attainment plan for a higher classification of an air quality standard. At the time of the proposed finding and reclassification for Las Vegas, there was nearly two full years until the area's attainment date, including the entire attainment year ozone season of 2023.
Given these facts and circumstances, we think it is appropriate and necessary to establish deadlines that would result in the most expeditious schedule for adopting and implementing control
Areas initially classified as Moderate under the 2015 ozone NAAQS were required to prepare and submit SIP revisions by deadlines relative to the effective date of the nonattainment designation (
Section 181(b)(2)(A) of the CAA requires that within 6 months following the applicable attainment date, the EPA shall determine whether an ozone nonattainment area attained the ozone standard, and those areas that failed to attain and were not granted a 1-year attainment date extension are reclassified by operation of law. Although Congress did not articulate specific SIP submission deadlines for reclassified areas in the Act, it provided the EPA with authority under CAA section 182(i) to adjust any related deadlines for requirements under CAA sections 182(b) through (d) “. . . to the extent such adjustment is necessary or appropriate to assure consistency among the required submissions.” Notably, explicitly excluded from CAA section 182(i) is authority to adjust attainment dates.
The area classifications and attainment date framework established in Table 1 of CAA section 181(a)(1) and interpreted by 40 CFR 51.1303 inherently constrains the planning and implementation timeframe for reclassified areas, particularly for lower area classifications. The time increments between the Marginal and Moderate, and the Moderate and Serious area statutory attainment dates are only three years. These short timeframes are further constrained by the RACT implementation deadline for reclassified areas. Consistent with the RACT requirements of 40 CFR 51.1312(a)(3)(ii), the EPA proposed a RACT implementation deadline for the reclassified Las Vegas Moderate area corresponding with the beginning of the area's attainment year ozone season (
The EPA also notes that voluntary reclassification provides a way for states to anticipate and manage the tight timeframes for SIP development for nonattainment areas. An air agency can request—and the EPA
Thus, while we recognize that Clark County DES may face difficulty in meeting the submission and implementation deadlines in this final rule, we continue to believe our proposed approach is consistent with the CAA and our regulations. As a reclassified Moderate area, Las Vegas is required to attain the 2015 ozone NAAQS by August 3, 2024, and per Congress's clear statutory instruction in CAA section 182(i), the EPA may not alter attainment deadlines for reclassified areas. Given the competing considerations outlined above and the remaining planning options available for Clark County, we maintain that the deadlines imposed by the final action are reasonable, and an appropriate exercise of the EPA's discretion under CAA section 182(i).
Moreover, a states' obligation to adopt and implement RACT are not conditioned in any way on the EPA's action on those SIP revisions. There are no provisions of the CAA that permit states an extension of time to adopt SIP revisions or require implementation of control measures based on the timing of the EPA's action on the state's submissions. It is the state's obligation to adopt control measures and to implement those measures in order to attain the NAAQS, and the more expeditiously those controls are adopted and implemented, the likelier Las Vegas is to timely attain.
To the extent that the commenter does not think it will be possible to implement any controls beyond what has already been federally approved and recognizes that additional controls are necessary for that area to reach attainment, the area may, as discussed previously, exercise the option to request a voluntary reclassification, which the EPA must approve. The EPA cannot, under the CAA, reclassify ozone areas based on its presumption that an area will not attain or is unlikely to attain by the attainment date; but states are fully within their rights to recognize this and put themselves in a better position for longer planning and implementation timeframes.
Finally, the EPA disagrees with the commenter that it would be irrational to consider the attainment deadline when determining the proper RACT implementation deadline. The CAA and the EPA's regulations require the agency to consider the attainment date when determining the RACT implementation deadline.
With respect to the Las Vegas area, in contrast, attainment has not been demonstrated and the nonattainment area will be required to submit all SIP planning requirements for Moderate nonattainment areas in addition to RACT implementation. Given this context, considering the attainment deadline when determining the optimal timeline for RACT implementation is a reasonable exercise of discretion in ensuring continued progress towards attainment.
Pursuant to CAA section 181(b)(2) and after considering comments received, the EPA is finalizing its proposed determination that Las Vegas failed to attain the 2015 ozone NAAQS by the applicable attainment date of August 3, 2021. Therefore, upon the effective date of this final action, Las Vegas will be reclassified, by operation of law, as Moderate for the 2015 ozone NAAQS. Once reclassified as Moderate, Las Vegas will be required to attain the standard “as expeditiously as practicable” but no later than 6 years after the initial designation as nonattainment, which in this case would be no later than August 3, 2024. If the area attains the 2015 ozone NAAQS prior to the Moderate area attainment date, NDEP may request redesignation to attainment, provided the state can demonstrate at a minimum that the other criteria under CAA section 107(d)(3)(E) are met.
Pursuant to CAA section 182(i) and after considering comments received, the EPA is finalizing its proposed deadlines for the Las Vegas Moderate area SIP revisions and implementation of RACM/RACT for the 2015 ozone NAAQS. SIP revisions required for the newly reclassified Las Vegas Moderate area, including the I/M SIP revision, must be submitted no later than January 1, 2023, and RACM/RACT for these areas must be implemented as expeditiously as practicable, but no later than the same date.
For any revisions to the current I/M program that may be necessary, the EPA is finalizing an implementation deadline of no later than 4 years after the effective date of reclassification if the state does not intend to rely upon emissions reductions from a revised Basic I/M program in the Moderate area attainment or RFP demonstrations. The EPA received no comments on the implementation deadline for the Basic I/M program in Las Vegas.
Under APA section 553(d)(3), 5 U.S.C. 553(d)(3), an agency may make a rule immediately effective “for good cause found and published with the rule.” The EPA believes that there is “good cause” to make this rule effective upon publication in the
As described above, when 2020 monitoring data became available showing that the Las Vegas area may not have attained the 2015 ozone NAAQS, nor be eligible for a one-year extension, Clark County DES had every reason to anticipate and prepare for reclassification. In addition, EPA notified Clark County DES in April 2022 that it did not agree with the area's exceptional events demonstrations, published its proposed rule for this reclassification on July 22, 2022, and is providing direct notice to the state and county of this final action simultaneous with signature of this rule. Accordingly, the EPA finds that the preparation time actually available to the state and the need to reconcile the statutory interest in reclassification with the deadlines for submission of Moderate area SIP revisions and compliance with RACT implementation requirements, constitute good cause under 5 U.S.C. 553(d)(3) to make this final action effective upon publication.
This action is exempt from review by the Office of Management and Budget (OMB) because it responds to the CAA requirement to determine whether areas designated nonattainment for an ozone NAAQS attained the standard by the applicable attainment date, and to take certain steps for areas that failed to attain.
This rule does not impose any new information collection burden under the PRA not already approved by the Office of Management and Budget. This action does not contain any information collection activities and serves only to make final: (1) determinations that the Las Vegas Marginal nonattainment area failed to attain the 2015 ozone standards by the August 3, 2021, attainment date where such areas will be reclassified as Moderate nonattainment for the 2015 ozone standards by operation of law upon the effective date of the final reclassification action; and (2) adjust any applicable implementation deadlines.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. The determination of failure to attain the 2015 ozone standards (and resulting reclassifications), do not in and of themselves create any new requirements beyond what is mandated by the CAA. This final action would require the state to adopt and submit SIP revisions to satisfy CAA requirements and would not itself directly regulate any small entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The division of responsibility between the federal government and the states for purposes of implementing the NAAQS is established under the CAA.
The Las Vegas Tribe of Paiute Indians of the Las Vegas Indian Colony have areas of Indian country located within the Las Vegas Valley nonattainment area for the 2015 ozone NAAQS. The EPA has concluded that this final rule may have implications for this tribe for the purposes of Executive Order 13175 but would not impose substantial direct costs upon the tribes, nor would it preempt tribal law. A tribe that is part of an area that is reclassified from Marginal to Moderate nonattainment is not required to submit a tribal implementation plan revision to address new Moderate area requirements.
Given the potential implications, the EPA contacted tribal officials early in the process of developing our proposed rule to provide an opportunity to have meaningful and timely input into its development. In a letter dated July 16, 2021, the EPA invited the Las Vegas Tribe of Paiute Indians of the Las Vegas Indian Colony to consult on our evaluation and determination of whether the Las Vegas nonattainment area attained or failed to attain by its Marginal area attainment date and notified the Las Vegas Tribe of Paiute Indians of the Las Vegas Indian Colony of the proposed action. The tribe did not comment or request consultation.
The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
Executive Order 12898 establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make
This rule is exempt from the CRA because it is a rule of particular applicability. The rule makes factual determinations for specific entities and does not directly regulate any entities. The determination of failure to attain the 2015 ozone NAAQS (and resulting reclassification), do not in themselves create any new requirements beyond what is mandated by the CAA.
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 6, 2023. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, and Volatile organic compounds.
For the reasons stated in the preamble, part 81, title 40, chapter 1 of the Code of Federal Regulations are amended as follows:
42 U.S.C. 7401,
Federal Communications Commission.
Final rule.
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act) requires the Federal Communications Commission to amend its forfeiture penalty rules to reflect annual adjustments for inflation in order to improve their effectiveness and maintain their deterrent effect. The Inflation Adjustment Act provides that the new penalty levels shall apply to penalties assessed after the effective date of the increase, including when the penalties whose associated violation predate the increase.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
Lisa Gelb, Deputy Chief, Enforcement Bureau, at
This is a summary of the Commission's Order, DA 22-1356, adopted and released on December 23, 2022. The document is available for download at
The Bipartisan Budget Act of 2015 included, as section 701 thereto, the Inflation Adjustment Act, which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410), to improve the effectiveness of civil monetary penalties and maintain their deterrent effect. Under the Inflation Adjustment Act, agencies are required to make annual inflationary adjustments by January 15 each year, beginning in 2017. The adjustments are calculated pursuant to Office of Management and Budget (OMB) guidance. OMB issued guidance on December 15, 2022, and this Order follows that guidance. The Commission therefore updates the civil monetary penalties for 2023, to reflect an annual inflation adjustment based on the percent change between each published October's CPI-U; in this case, October 2022 CPI-U (298.012)/October 2021 CPI-U (276.589) = 1.07745. The Commission multiplies 1.07745 by the most recent penalty amount and then rounds the result to the nearest dollar.
For 2023, the adjusted penalty or penalty range for each applicable penalty is calculated by multiplying the most recent penalty amount by the 2023 annual adjustment (1.07745), then rounding the result to the nearest dollar. The adjustments in civil monetary penalties that we adopt in this Order apply only to such penalties assessed on and after January 15, 2023.
This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It does not contain any new or modified 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,
The Commission has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs that this rule is non-major under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).
Administrative practice and procedure, Penalties.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows:
47 U.S.C. chs. 2, 5, 9, 13; 28 U.S.C. 2461 note, unless otherwise noted.
(b) * * *
(1)
(2)
(3)
(4)
(5)
(6)
(ii) Any person who willfully and knowingly violates the Act or any rule, regulation, restriction, or condition made or imposed by the Commission under authority of the Act, or any rule, regulation, restriction, or condition made or imposed by any international radio or wire communications treaty or convention, or regulations annexed thereto, to which the United States is party, relating to pirate radio broadcasting shall, in addition to any other penalties provided by law, be subject to a fine of not more than $115,802 for each day during which such offense occurs, in accordance with the limit described in this section.
(7)
(8)
(9)
(10) * * *
(11) * * *
(ii) The application of the annual inflation adjustment required by the foregoing Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 results in the following adjusted statutory maximum forfeitures authorized by the Communications Act:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; quota transfer.
NMFS is transferring 20.5 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the General category December 2023 subquota to the January through March 2023 subquota period. The adjusted General category January through March 2023 subquota is 58.2 mt. This action is provides further opportunities for General category fishermen to participate in the January through March General category fishery, based on consideration of the regulatory determination criteria regarding inseason adjustments. This action would affect Atlantic Tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT.
Effective January 3, 2023, through March 31, 2023.
Larry Redd, Jr.,
Atlantic HMS fisheries, including BFT fisheries, are managed under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
The baseline General category quota is 710.7 mt. The General category baseline subquotas for the January through March time-period and for the December time-period are 37.7 mt and 37.0 mt, respectively. In this action, NMFS is transferring 20.5 mt from the December 2023 subquota period to the January through March subquota period. This transfer results in 58.2 mt (37.7 mt + 20.5 mt = 58.2 mt) being available for the January through March 2023 subquota period and 16.5 mt (37.0−20.5 = 16.5 mt) being available for the December 2023 subquota period.
Under § 635.27(a)(1)(ii), NMFS has the authority to transfer subquota from one time period to another time period through inseason action after considering determination criteria provided under § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to this inseason quota transfer. These considerations include, but are not limited to, the following.
Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen continue to provide NMFS with valuable parts and data for ongoing scientific studies of
NMFS also considered recent catches of the General category quota (including in December 2022 and during the January through March fishery in the last several years) and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). Without a quota transfer from the December 2023 subquota period, the quota available for the 2023 January through March period would be 37.7 mt and participants would have to stop BFT fishing activities once that amount is met, while commercial-sized BFT remain available in the areas where General category permitted vessels operate. A quota transfer of 20.5 mt would provide limited additional opportunities to harvest the U.S. BFT quota while avoiding exceeding it.
Regarding the projected ability of the vessels fishing under the General category quota to harvest the additional amount of BFT quota transferred before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered General category landings over the last several years. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. NMFS may adjust each period's subquota based on overharvest or underharvest in the prior period and may transfer subquota from one time period to another time period. By allowing for such quota adjustments and transfers, NMFS anticipates that the General category quota would be used before the end of the fishing year. For 2022, NMFS transferred 19.5 mt of quota from the December 2022 subquota period to the January through March 2022 subquota period, resulting in an adjusted subquota of 49 mt for the January through March 2022 period and an adjusted subquota of 9.4 mt for the December 2022 period (86 FR 72857, December 23, 2021). NMFS also made a transfer of 26 mt from the Reserve to the General category effective January 28, 2022, resulting in an adjusted subquota of 75 mt for the January through March 2022 period (87 FR 5737, February 2, 2022), and closed the General category fishery for the January through March subquota period effective February 11, 2022 (87 FR 8432, February 15, 2022).
NMFS also considered the estimated amounts by which quotas for other gear categories of the BFT fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2023 landings and dead discards. In the last several years, total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2023 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and anticipates having sufficient quota to do that.
NMFS also considered the effects of the adjustment on the BFT stock and the effects of the transfer on accomplishing the objectives of the 2006 Consolidated FMP (§ 635.27(a)(8)(v) and (vi)). This transfer would be consistent with established quotas and subquotas, which are implemented consistent with ICCAT recommendations (established in Recommendation 21-07), ATCA, and the objectives of the 2006 Consolidated HMS FMP and amendments. In establishing these quotas and subquotas and associated management measures, ICCAT and NMFS considered the best scientific information available, objectives for stock management and status, and effects on the stock. This quota transfer is in line with the established management measures and stock status determinations. Another principal consideration is the objective of providing opportunities to harvest the available General category quota without exceeding the annual quota, based on the objectives of the 2006 Consolidated HMS FMP and its amendments, including to achieve optimum yield on a continuing basis and to allow all permit categories a reasonable opportunity to harvest available BFT quota allocations (related to § 635.27(a)(8)(x)). Specific to the General category, this includes providing opportunities equitably across all time periods.
Given these considerations, NMFS is transferring 20.5 mt from the December 2023 period to the January through March 2023 period, resulting in an adjusted January through March 2023 subquota of 58.2 mt and an adjusted December 2023 subquota of 16.5 mt. The General category fishery will remain open until March 31, 2023, or until the adjusted General category quota is reached, whichever comes first.
NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustments, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General category and HMS Charter/Headboat vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or the end of each trip, by accessing
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act and regulations at 50 CFR part 635 and is exempt from review under Executive Order 12866.
The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing prior notice and opportunity for public comment on this quota transfer for the January through March 2023 time period is impracticable. NMFS could not have proposed this action earlier, as it needed to consider and respond to updated landings data, including the recently available December 2022 data, in deciding to transfer a portion of the December 2023 subquota to the January through March 2023 subquota. Delaying this action is contrary to public interest, not only because it would likely result in a General category closure and associated costs to the fishery, but also administrative costs due to further agency action needed to re-open the fishery after quota is transferred. The
For all of the above reasons, the AA finds that pursuant to 5 U.S.C. 553(d), there also is good cause to waive the 30-day delay in effective date.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
We are finalizing specifications for the 2023 Atlantic deep-sea red crab fishery, including an annual catch limit, and total allowable landings limit. This action is necessary to fully implement previously projected allowable red crab harvest levels that will prevent overfishing and allow harvesting of optimum yield. This action is intended to establish the allowable 2023 harvest levels, consistent with the Atlantic Deep-Sea Red Crab Fishery Management Plan.
The final specifications for the 2023 Atlantic deep-sea red crab fishery are effective March 1, 2023, through February 29, 2024.
Laura Deighan, Fishery Management Specialist, (978) 281-9184.
The Atlantic deep-sea red crab fishery is managed by the New England Fishery Management Council. The Atlantic Deep-Sea Red Crab Fishery Management Plan includes a specification process that requires the Council to recommend an acceptable biological catch, an annual catch limit, and total allowable landings every four years. Collectively, these are the red crab specifications. Prior to the start of fishing year 2020, the Council recommended specifications for the 2020-2023 fishing years (Table 1).
On April 14, 2020, we approved the Council-recommended specifications for the 2020 fishing year, effective through February 28, 2021, and we projected the continuation of those specifications for 2021-2023 (85 FR 20615). At the end of each fishing year, we evaluate catch information and determine if the quota has been exceeded. If a quota is exceeded, the regulations at 50 CFR 648.262(b) require a pound-for-pound reduction in a subsequent fishing year. We have reviewed available 2022 fishery information against the projected 2023 specifications. There have been no annual catch limit or total allowable landings overages, nor is there any new biological information that would require altering the projected 2023 specifications published in 2020. Based on this information, we are finalizing specifications for fishing year 2023, as projected in the 2020 specifications rule, and outlined above in Table 1. These specifications are not expected to result in overfishing, and they adequately account for scientific uncertainty. This is the final year of these specifications, and new specifications will be developed by the Council for 2024 and beyond.
The NMFS Assistant Administrator has determined that this final rule is consistent with the Atlantic Deep-Sea Red Crab Fishery Management Plan, the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable law.
This rule is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), we find good cause to waive prior public notice and opportunity for public comment on the catch limit and allocation adjustments, because allowing time for notice and comment would be contrary to the public interest. The proposed rule for the 2020-2023 specifications provided the public with the opportunity to comment on the specifications, including the projected 2021 through 2023 specifications (85 FR 9717, February 20, 2020). We received no comments on the proposed rule announcing the projected 2021-2023 specifications and the process for announcing finalized interim year quotas. Further, this final rule contains no changes from the projected 2023 specifications that were included in both the February 20, 2020, proposed rule and the April 14, 2020, final rule. The public and industry participants expect this action. Through both the proposed rule for the 2020-2023 specifications and the final rule for the 2020 specifications, we alerted the public that we would conduct a review of the latest available catch information in each of the interim years of the multi-year specifications and announce the final quota prior to the March 1 start of the fishing year. Thus, the proposed and final rules that contained the projected 2021-2023 specifications provided a full opportunity for the public to comment on the substance and process of this action.
The Chief Counsel for Regulation, Department of Commerce, previously certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that the 2020-2023 red crab specifications would not have a significant economic impact on a substantial number of small entities. Implementing the 2023 specifications will not change the conclusions drawn in that previous certification to the SBA. Because advance notice and the opportunity for public comment are not required for this action under the Administrative Procedure Act, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601,
This action does not contain a collection of information requirement for the purposes of the Paperwork Reduction Act.
16 U.S.C. 1801
In rule document 2022-28343 appearing on pages 80090-80094 in the issue of December 29, 2022, make the following corrections:
1. On page 80093, in Table 9, in the first column, in the 13th and 14th lines down, “Hook-and-line catcher vessel ≤60 ft LOA” should read, “Hook-and-line catcher vessel ≥60 ft LOA”.
2. On the same page, in the same table, in the same column, in the 16th line down, “Pot catcher vessel ≤60 ft LOA” should read, “Pot catcher vessel ≥60 ft LOA”.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using hook-and-line (HAL) gear in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2023 total allowable catch of Pacific cod by catcher vessels using HAL gear in the Western Regulatory Area of the GOA.
Effective 0001 hours, Alaska local time (A.l.t.), January 1, 2023, through 1200 hours, A.l.t., June 10, 2023.
Krista Milani, 907-581-2062.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The A season allowance of the 2023 Pacific cod total allowable catch (TAC) apportioned to catcher vessels using HAL gear in the Western Regulatory Area of the GOA is 35 metric tons (mt) as established by the final 2022 and 2023 harvest specifications for groundfish in the GOA (87 FR 11599, March 2, 2022) and inseason adjustment (87 FR 80088, December 29, 2022). The Regional Administrator has determined that the 2023 TAC apportioned to catcher vessels using HAL gear in the Western Regulatory Area of the GOA is necessary to account for the incidental catch of this species in other anticipated groundfish fisheries for the 2023 fishing year. Therefore, in accordance with § 679.20(d)(1)(i), the Regional Administrator establishes the directed fishing allowance for catcher vessels using HAL gear in the Western Regulatory Area of the GOA as 0 mt. Consequently, in accordance with § 679.20(d)(1)(iii), NMFS is prohibiting directed fishing for catcher vessels using HAL gear in the Western Regulatory Area of the GOA.
While this closure is effective, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion, and would delay the closure of Pacific cod by catcher vessels using HAL gear in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 29, 2022.
The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of proposed rulemaking and announcement of public meeting.
The U.S. Department of Energy (“DOE”) proposes to amend its test procedure for uninterruptible power supplies (“UPSs”) to consider the latest revision of the industry standard that is incorporated by reference and to provide an optional test method for measuring power consumption of a UPS at no-load conditions. DOE is seeking comment from interested parties on the proposal.
DOE will accept comments, data, and information regarding this proposal no later than March 6, 2023. See section V, “Public Participation,” for details.
DOE will hold a public meeting via webinar on Thursday, February 2, 2023, from 1:00 p.m. to 4:00 p.m. See section V, “Public Participation,” for webinar registration information, participant instructions, and information about the capabilities available to webinar participants.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
No telefacsimiles (“faxes”) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section V of this document.
The docket web page can be found at
Mr. Jeremy Dommu, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-2J, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-9870. Email
Ms. Kristin Koernig, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-3593. Email:
For further information on how to submit a comment, review other public comments and the docket, or participate in a public meeting, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email:
DOE proposes to incorporate by reference the following industry standard into 10 CFR part 430:
Copies of IEC 62040-3 Ed. 3.0 are available from the International Electrotechnical Commission, 3 Rue de Varembe, Case Postale 131, 1211 Geneva 20, Switzerland;
For a further discussion of this standard, see section IV.M of this document.
UPSs are a class of battery chargers and fall among the consumer products for which DOE is authorized to establish and amend energy conservation standards and test procedures. (42 U.S.C. 6295(u)) DOE's energy conservation standards and test procedure for UPSs are currently prescribed at title 10 of the Code of Federal Regulations (“CFR”), part 430 section 32(z)(3); and 10 CFR part 430, subpart B, appendix Y (“appendix Y”) and appendix Y1 (“appendix Y1”). The following sections discuss DOE's authority to establish a test procedure for UPSs and relevant background information regarding DOE's consideration of the test procedure for this product.
The Energy Policy and Conservation Act, Public Law 94-163, as amended (“EPCA”),
The energy conservation program under EPCA consists essentially of four parts: (1) testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA specifically include definitions (42 U.S.C. 6291), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), energy conservation standards (42 U.S.C. 6295), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).
The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making other representations about the efficiency of those consumer products (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the products comply with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
Federal energy efficiency requirements for covered products established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6297) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions of EPCA. (42 U.S.C. 6297(d))
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use, and not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))
EPCA also requires that, at least once every seven years, DOE evaluate test procedures for each type of covered product, including UPSs, to determine whether amended test procedures would more accurately or fully comply with the requirements for the test procedures to not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle or period of use. (42 U.S.C. 6293(b)(1)(A))
If the Secretary determines, on her own behalf or in response to a petition by any interested person, that a test procedure should be prescribed or amended, the Secretary shall promptly publish in the
In addition, EPCA requires that DOE amend its test procedures for all covered products to integrate measures of standby mode and off mode energy consumption. (42 U.S.C. 6295(gg)(2)(A)). Standby mode and off mode energy consumption must be incorporated into the overall energy efficiency, energy consumption, or other energy descriptor for each covered product unless the current test procedures already account for and incorporate standby and off mode energy consumption or such integration is technically infeasible. If an integrated test procedure is technically infeasible, DOE must prescribe a separate standby mode and off mode energy use test procedure for the covered product, if technically feasible. (42 U.S.C. 6295(gg)(2)(A)(ii)). Any such amendment must consider the most current versions of the International Electrotechnical Commission (IEC) Standard 62301
DOE is publishing this notice of proposed rulemaking (“NOPR”) in satisfaction of the 7-year review requirement specified in EPCA. (42 U.S.C. 6293(b)(1)(A))
On December 12, 2016, DOE amended its battery charger test procedure by publishing a final rule in the
On September 8, 2022, DOE published a final rule in the
On February 2, 2022, DOE initiated a rulemaking process to consider amendments to the UPS test procedure by publishing in the
DOE received comments in response to the February 2022 RFI from the interested parties listed in Table I.1.
A parenthetical reference at the end of a comment quotation or paraphrase provides the location of the item in the public record.
In this NOPR, DOE proposes to amend appendices Y and Y1 as follows:
(1) Incorporate by reference the current revision to the applicable industry standard—IEC 62040-3 Ed. 3.0, “Uninterruptible power systems (UPS)—Part 3: Method of specifying the performance and test requirements”—to reflect redesignated subsections in the latest version of that standard.
(2) Provide an optional test method for measuring the power consumption of UPSs at no-load conditions.
DOE's proposed actions are summarized in Table II.1 compared to the current test procedure, with the reason for the proposed change also provided.
Discussion of DOE's proposed actions are addressed in detail in section III of this NOPR.
In the following sections, DOE proposes certain amendments to its test procedure for UPSs. For each proposed amendment, DOE provides relevant background information, explains why the amendment merits consideration, discusses relevant public comments, and proposes a potential approach.
The scope of the current test procedure at appendices Y and Y1, as applicable to UPSs, covers UPSs
In the February 2022 RFI, DOE sought comment on whether the scope of the test procedure as it pertains to UPSs is still appropriate or whether DOE should consider any changes in scope. 87 FR 5742, 5744.
NEMA commented that it did not see any need for changes to the UPS test procedure with regards to scope. (NEMA, No. 2 at p. 2)
Conversely, the Joint Commenters recommended that DOE investigate opportunities to expand the scope of the UPS test procedure to cover back-up battery chargers such as portable power systems. (Joint Commenters, No. 3 at p. 1) The Joint Commenters stated that portable power systems are an emerging class of products that are becoming increasingly common for homes given the need for back-up power in climate emergencies and power outage situations. (
NEEA similarly encouraged DOE to expand the scope of the battery charger test procedure to include portable power stations that utilize batteries and to test them using the appendix Y battery charger test instructions. (NEEA, No. 5 at p. 7) NEEA stated that its research reveals that consumer portable power stations are experiencing rapid market adoption. (
However, NEEA stated that its technical research supported addressing consumer portable power stations within the non-UPS portion of the test procedure and not the UPS portion because (1) they supply loads when not connected to the grid, whereas the UPS test procedure focuses on the efficiency of a continuously grid-connected system; (2) they have a variety of duty cycles, such that the variety of use scenarios is like other consumer chargers covered by the non-UPS portion of the test procedure; and (3) they have different charge rates, and the battery charger test procedure already accommodates variations in charge rates. (
Relevant to consideration of these comments, the scope of DOE's battery charger test procedure includes all battery chargers operating at either direct current (“DC”) or United States AC line voltage (115V at 60Hz). Appendix Y, section 1. To the extent that a portable power system meets the definition of a battery charger, operates on DC or United States AC line voltage, but does not meet the definition of a back-up battery charger as defined by DOE, such a product is currently covered within the scope of the non-UPS portion of the battery charger test procedure. Based on the descriptions of products described by NEEA, DOE tentatively concludes that such products may not meet the definition of “back-up battery charger” because they are not embedded in a separate end-use product. Rather, the power station itself is the end-use product and is not used to maintain power in the event of mains power failure. In contrast to NEEA's findings, DOE has identified—based on a review of product literature—a wide range of portable power stations currently certified as non-UPS battery chargers and listed in the CCD,
To the extent that a portable power station meets DOE's definition of a back-up battery charger, such a product is currently outside the scope of appendices Y and Y1. As suggested by NEEA, DOE tentatively agrees that the operational characteristics of portable power stations that are not back-up battery chargers are in the scope of the non-UPS portion of the appendices Y and Y1 test procedure and not the UPS portion. Therefore, changes to the non-UPS portion of appendices Y and Y1 are outside the scope of this rulemaking and DOE is not proposing any changes to the UPS portion of appendices Y and Y1 to address such products.
The CA IOUs noted that the current scope of the UPS test procedure is limited to UPSs that use standard NEMA 1-15P/5-15P wall plugs
DOE's initial review of the market for the types of products discussed by the CA IOUs confirms the CA IOUs' findings that such products either do not appear to meet the definition of a UPS and/or do not use NEMA 1-15P/5-15P wall plugs. In addition, DOE tentatively determines that the test
As discussed, DOE defines a UPS as a battery charger consisting of a combination of convertors, switches, and energy storage devices (such as batteries), constituting a power system for maintaining continuity of load power in case of input power failure. Appendices Y and Y1, section 2.27. This definition aligns with the definition of a UPS provided in IEC 62040-3 Ed. 2.0, which is currently incorporated by reference in appendices Y and Y1.
In the February 2022 RFI, DOE sought comment on whether the current definition for a UPS is still appropriate or whether DOE should consider an amended definition. 87 FR 5742, 5744.
NEMA commented that the definition of a UPS should be updated to align with IEC 62040-3 Ed. 3.0. (NEMA, No. 2 at p. 2) Specifically, NEMA recommended amending the UPS definition to read “. . . maintaining continuity of
DOE recognizes the benefit of harmonizing with the latest versions of industry standards where applicable and appropriate. DOE has tentatively determined that the addition of the term “AC” in the IEC 62040-3 Ed. 3.0 definition is consistent with the range of products that meet the current definition of a UPS and would not change the scope of products subject to the test procedure.
DOE requests comment on its proposal to harmonize its definition of a UPS with that of IEC 62040-3 Edition 3.0. Specifically, DOE requests comment on its tentative determination that such harmonization would not affect the current scope of the UPS test procedure.
NEMA also suggested that DOE adopt or harmonize several other definitions from IEC 62040-3 Ed. 3.0, specifically, total harmonic distortion (“THD”), voltage independent (“VI”) UPS, and voltage and frequency independent (“VFI”) UPS.
Section 2.26 of appendices Y and Y1 defines THD, expressed as a percent, as the root mean square (“RMS”) value of an AC signal after the fundamental component is removed and interharmonic components are ignored, divided by the RMS value of the fundamental component. Section 3.5.49 of IEC 62040-3 Ed. 3.0 defines THD as the ratio of the RMS value of the sum of the harmonic components X
DOE has carefully reviewed its definitions of VFD UPS,
DOE notes that there are scenarios where using the manufacturer declared limits may result in a different input dependency classification of a UPS when compared to that conducted using DOE's current input voltage tolerance limits. For example, a manufacturer that declares an input voltage tolerance limit of ±15 percent for a VI basic model but could have a unit that is unable to maintain the required output when the input voltage is adjusted by more than 13 percent in real world testing. Per the IEC definition, this unit would fail the VI input dependency at the manufactured declared limits of ±15 percent and therefore be classified as a VFD UPS (the highest input dependent UPS topology). However, the same unit when tested per DOE's current input voltage limits of ±10 percent would continue to classify it as a VI.
To avoid such discrepancies, DOE proposes to harmonize its definitions of VFD UPS, VI UPS, and VFI UPSs with IEC 62040-3 Ed 3.0 but maintain the notes alongside each definition that currently establish the input voltage and frequency tolerance limits of ±10 percent and ±2 percent, respectively.
DOE notes that the section numbers of IEC 62040-3 Ed. 2.0 currently referenced by DOE's definitions have been updated to different section numbers in IEC 62040-3 Ed. 3.0. DOE proposes to update its definitions of VFD UPS, VI UPS, and VFI UPS to reference the corresponding updated section numbers within IEC 62040-3 Ed. 3.0.
DOE has initially determined that the proposed amended definitions would not substantively change the scope or applicability of the test procedure as compared to the current definitions.
DOE requests comment on its proposal to update its definitions of THD, VFD UPS, VI UPS, and VFI UPC to harmonize with the IEC 62040-3 Ed 3.0 definitions.
As discussed, the current UPS test procedure incorporates by reference certain sections of IEC 62040-3 Ed. 2.0 regarding test setup, input and output power measurement, and the optional determination of UPS architecture. Specifically:
• The definitions of VFD UPS, VFI UPS, and VI UPS in sections 2.27.1 through 2.27.3 of appendices Y and Y1 reference: (1) the AC input failure test in section 6.2.2.7 of IEC 62040-3 Ed. 2.0, which in turn references section 5.3.4 and Annex G of IEC 62040-3 Ed. 2.0; (2) the steady state input voltage tolerance test in section 6.4.1.1 of IEC 62040-3 Ed. 2.0, as a subsection to section 6.4.1, which in turn references sections 5.2.1 and 5.2.2.k of IEC 62040-3 Ed. 2.0; and (3) the input frequency tolerance test in section 6.4.1.2 of IEC 62040-3 Ed. 2.0, which in turn references sections 5.3.2.d and 5.3.2.3 of IEC 62040-3 Ed. 2.0.
• Section 4.2.1 of appendices Y and Y1 specifies configuring the UPS according to Annex J.2 [of Annex J] of IEC 62040-3 Ed. 2.0.
• Section 4.3.3 of appendices Y and Y1 specifies measuring input and output power according to section J.3 of Annex J of IEC 62040-3 Ed. 2.0.
Since publication of the December 2016 Final Rule, IEC has updated the IEC 62040-3 standard to its third edition (
Section 4 of IEC 62040-3 Ed. 3.0 includes updates to various environmental conditions, such as the general test environment and operating conditions when testing UPSs. Appendices Y and Y1, however, do not refer to section 4 of the IEC 62040-3 standard but instead provide their own environmental and operating conditions for testing purposes. DOE has therefore determined that its test procedure for measuring the efficiency of UPSs will remain unaffected by the updates to section 4 of the IEC 62040-3 Ed. 3.0.
Section 5.2 of IEC 62040-3 Ed. 2.0 addresses UPS input specifications, such as the input voltage range, input frequency range, and total harmonic distortions during which the UPS under test must remain in the normal mode of operation. While an initial review of IEC 62040-3 Ed. 3.0 shows significant editorial changes to the sections that define these parameters, the remainder of the parameters remain unchanged. Similarly, section 5.3 of IEC 62040-3 Ed. 3.0 provides the minimum output specifications for UPSs that must be declared by manufacturers, such as its input dependency, rated output voltage and RMS output voltage tolerance band, rated frequency tolerance band, rated output active and apparent power, total harmonic distortion, etc. As before, the majority of the changes to this section are editorial or a reorganization.
Section 6 of IEC 62040-3 Ed. 2.0 previously provided instructions for performing the AC input failure test (section 6.2.2.7), the steady-state input voltage tolerance test (section 6.4.1.1), and the input frequency tolerance test (section 6.4.1.2) that are used to classify the input dependency of a UPS as VI, VFD, or VFI. IEC 62040-3 Ed. 3.0 has since updated these subsections with the following changes: subsection titles and numbering have been updated to specifically refer to them as VI, VFD, and VFI input dependency tests; additional criteria have been added for meeting the VI, VFD, and VFI classifications; and a new test load condition at 0 percent (
Additional updates to Annex J to IEC 62040-3 Ed. 3.0 require multi-mode UPSs to be tested at all dependency modes, whereas DOE's current test procedure explicitly requires UPSs to be tested at only their highest and lowest input dependency modes. Annex J has also been updated to allow manufacturers to test UPSs with functions or ports set to the lowest power-consuming mode or disconnected if they are not related to maintaining the energy storage device (
In the February 2022 RFI, DOE requested comment on the updates made to IEC 62040-3 Ed. 3.0 and on whether DOE should revise all or parts of its incorporation by reference to harmonize with these changes. 87 FR 5742, 5745. DOE also requested feedback on whether any of the specific updates found in the new IEC standard has the potential to alter the recorded efficiency of UPSs as currently measured by appendix Y.
DOE received several comments regarding aligning its reporting requirements for UPSs with the requirements in the revised Annex J in IEC 62040-3 Ed. 3.0 in response to the February 2022 RFI. The Joint Commenters, NEEA, and NEMA all requested that DOE require manufacturers to report which (if any) additional functionality was switched off for testing. (Joint Commenters, No. 3 at p. 2; NEEA, No. 5 at p. 7; NEMA, No. 2 at p. 4). NEMA commented that adding free text fields in the certification database spreadsheet template would reduce the reporting burden of uploading additional supplementary documentation to provide this information. (NEMA, No. 2 at p. 4) Additionally, NEEA noted that collecting this information increases stakeholder transparency and provides DOE with useful information for future analyses. (NEEA, No. 5 at p. 7)
DOE is not proposing to amend the certification or reporting requirements for UPSs in this NOPR. Instead, DOE may consider proposals to amend the certification requirements and reporting for UPSs under a separate rulemaking regarding appliance and equipment certification.
In response to the February 2022 RFI, NEMA suggested that DOE incorporate the 15-minute accumulated energy measurement method found in Annex J of IEC 62040-3 Ed. 3.0, commenting that it is the measurement method favored by DOE because DOE already includes such a method in appendices Y and Y1. (NEMA, No. 2 at p. 2) NEMA also recommended that DOE incorporate sections 5.2 and 5.3 of IEC 62040-3 or the entire standard and stated that doing so would not alter the measured efficiency of UPSs. (
DOE has carefully reviewed IEC 62040-3 Ed. 3.0 as it relates to measuring the efficiency of a UPS. DOE has tentatively determined that the relevant updates to IEC 62040-3 Ed. 3.0 compared to IEC 62040-3 Ed. 2.0 are largely editorial, including renumbering of certain sections referenced by the DOE test procedure, and that updating DOE's existing references to IEC 62040-3 Ed. 3.0 would not alter the measured efficiency of basic models. As a result, DOE proposes to update its incorporation by reference of IEC 62040-3 Ed. 2.0 to IEC 62040-3 Ed. 3.0 in 10 CFR 430.3 and to update its references in appendices Y and Y1 accordingly to reflect the renumbering of sections in IEC 62040-3 Ed. 3.0.
As stated by NEMA in its written comment, DOE's existing test procedure for UPSs already allows recording of either instantaneous power or accumulated energy over a 15-minute period. DOE's review of Annex J in IEC 62040-3 Ed. 3.0 did not reveal any additional instructions that would further facilitate the use of the accumulated energy method. As such, DOE is not proposing any changes to its existing language in section 4.3.3 of appendices Y and Y1.
DOE requests comment on its proposal to incorporate by reference IEC 62040-3 Ed 3.0 and to update references in appendices Y and Y1 accordingly to reflect the renumbering of sections in IEC 62040-3 Ed 3.0.
Section 4.3.3 of appendices Y and Y1 requires that the efficiency of a UPS be measured at 100, 75, 50, and 25 percent of the device's rated output power. Each of these measured efficiencies is weighted according to values provided in Table 4.3.1 of appendices Y and Y1 and combined to determine a single weighted average output metric (
In the February 2022 RFI, DOE requested comment on whether the UPS load weightings specified in Table 4.3.1 are representative of current UPS usage patterns. 87 FR 5742, 5746. DOE also requested data on the consumer usage profile of UPSs with respect to each architecture (
NEEA, the Joint Commenters, and the CA IOUs all recommended introducing a fifth loading test condition at 10 percent of the device's rated output power, asserting that such a loading condition is more representative of desktop computers and other loads typically protected by UPSs. They further asserted that adding a 10-percent loading condition to UPS testing, along with a revised load weighting, would provide a more accurate efficiency value. (NEEA, No. 5 at pp. 1-4; Joint Commenters, No. 3 at pp. 1-2; CA IOUs, No. 4 at pp. 2-3)
NEMA, however, advised against adding a 10-percent loading condition and adjusting the loading level weights without significant evidence to support making such adjustments, arguing that DOE should maintain harmonization with IEC 62040-3 Ed. 3.0. NEMA further asserted that additional load test points are mathematically unnecessary and would invalidate testing already performed, which would impose a significant burden on manufacturers with no tangible benefits. NEMA further commented that mathematical loss models can be used to accurately predict UPS efficiency at any load point based on the five measurements already required by the DOE test procedure. (NEMA, No. 2 at p. 6)
As discussed, EPCA requires that any test procedures prescribed or amended under this section be reasonably designed to produce test results that measure energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use, and not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) As such, DOE must weigh the representativeness of test results with the associated test burden in evaluating any amendments to its test procedures. Regarding the representativeness of the DOE test procedure, the commenters have not provided specific data, nor is DOE aware of any specific data, demonstrating that a 10-percent loading condition would produce a more representative measure of energy use or energy efficiency of UPSs. In addition,
Regarding test burden, as noted, the loading points currently specified in appendices Y and Y1 are consistent with the loading points defined by ENERGY STAR, as well as section 6.4.1.6 of IEC 62040-3 Ed. 3.0. DOE also notes that the requirements of IEC 62040-3 Ed. 3.0 are referenced by the European Union Code of Conduct on Energy Efficiency and Quality of AC UPSs Version 2.0.
Having weighed the potential improvement to representativeness against the potential for increased test burden associated with adding a required 10-percent loading condition that would be applicable to all UPSs, DOE has tentatively concluded—based on information currently available—that the potential burden would outweigh any potential improvement in representativeness;
DOE requests comment on its proposal to not modify the existing loading points, weighting, or the overall efficiency metric in the current UPS test procedure.
DOE's test procedure for UPSs does not currently specify a method for determining the energy consumption of a UPS at no-load (
In response to the February 2022 RFI, the Joint Commenters recommended that DOE incorporate the no-load test condition into its UPS test procedure and establish a separate standby mode metric based on the no-load test condition. The Joint Commenters asserted that a standby mode measurement at the no-load test condition would provide consumers with a more accurate understanding of UPS energy consumption and would align DOE's UPS test procedure more closely with DOE's external power supply (“EPS”) and battery charger test procedures. The Joint Commenters asserted that the no-load condition of a UPS aligns closely with battery charger maintenance mode—in which a battery charger is connected to a battery and provides some limited charging in order to maintain the battery at full charge—and that because DOE determined that battery charge maintenance mode qualifies under EPCA's definition of standby mode,
NEEA also encouraged DOE to add a no-load test condition to the UPS test procedure. NEEA asserted that UPSs operate at no-load or low-load when attached equipment, such as desktop computers, are powered off or running in sleep or idle modes; that relevant studies suggest that desktop computers spend much of their time powered off or in sleep or idle modes; and that the substantial differences in no-load input power across UPS models suggest a significant energy savings opportunity. (NEEA, No. 5 at pp. 1-2) Based on its analysis of cited research, NEEA concluded that a no-load condition would effectively represent desktop computer off and sleep modes. (
DOE recognizes the usefulness of a no-load power consumption metric to the industry and stakeholders, as evidenced by the inclusion of a no-load test in IEC 62040-3 Ed. 3.0, its inclusion as a reporting requirement for the ENERGY STAR UPS Specification Version 2.0, and comments from interested parties in response to the February 2021 RFI. For these reasons, DOE proposes to incorporate by reference the no-load test condition specified in section 6.4.1.10 of IEC 62040-3 Ed. 3.0 as a test in section 4.3.3 of appendices Y and Y1 that would be used as the basis for any representations of no-load power consumption. However, DOE notes that manufacturers will not be required to certify no-load power consumption to DOE as a result of this proposal because the energy conservation standards for UPSs do not have a no-load requirement at this time.
DOE requests feedback on its proposal to add a method for measuring the power consumption of UPSs at no-load as a test to be used as the basis for any representations of no-load power consumption.
DOE's test procedure refers to the 25, 50, 75, and 100-percent loads as “reference test loads.” In general, test loads for testing consumer electronics can be either linear
While IEC 62040-3 Ed. 2.0 provides a definition for reference test load,
In response to the February 2022 RFI, NEEA recommended that to improve the representativeness of the UPS test procedure, DOE should require active mode testing employing the non-linear load specified in Annex E of IEC 62040-3 Ed. 3.0. NEEA stated that nearly all UPS loads are non-linear (
Section D.2 in Annex D of IEC 62040-3 Ed. 3.0 explains that the diversity of types of load equipment and their relevant characteristics are always changing with technology. For this reason, the UPS output performance is characterized by loading with passive reference loads to simulate, as far as practical, the expected load types, but it cannot be taken that these load types are totally representative of the actual load equipment in a given application. The UPS industry has generally specified UPS output characteristics under conditions of linear loading,
While DOE recognizes that loads protected by UPSs can be non-linear, the use of non-linear loads for testing may create certain challenges or difficulties in meeting the specified test conditions, as described within section D.2 of IEC 62040-3 Ed. 3.0. This suggests that testing with non-linear loads may produce results that are less repeatable or reproducible than testing with linear loads. DOE has no information, nor have commenters provided any information, about how the use of non-linear loads for UPS testing may affect repeatability, reproducibility, or test burden. As a result, DOE is not proposing the use of non-linear test loads for testing UPSs at this time.
At the time of the February 2022 RFI, paragraph (a) of section 4.2.1 of appendices Y and Y1, “UPS Operating Mode Conditions,” stated that if the UPS can operate in two or more distinct normal modes as more than one UPS architecture, conduct the test in its lowest input dependency as well as in its highest input dependency mode where VFD represents the
NEMA stated that specifying the “lowest” possible input dependency is a typographical error, and that VFD represents the highest possible input dependency rather than the lowest. (NEMA, No. 2 at p. 3) In a correcting amendment published May 11, 2022, DOE acknowledged that the text in paragraph (a) of section 4.2.1 of appendix Y erroneously identifies VFD as the lowest input dependency, whereas it is in fact the highest input dependency as identified in the referenced Annex J.2 of IEC 62040-3 Ed 2.0. 87 FR 28755, 28755. DOE corrected this error in the text by replacing the erroneous word “lowest” with “highest.”
EPCA requires that test procedures proposed by DOE not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) In this NOPR, DOE proposes to amend the existing test procedure for UPSs by updating the industry standard incorporated by reference to its latest version, updating definitions consistent with the latest version of the industry standard, and introducing an optional test for measuring the power consumption of UPSs at no-load conditions. DOE has tentatively determined that these proposed amendments would not be unduly burdensome for manufacturers to conduct.
The proposed update to the latest version of the industry standard would not change the method of testing UPSs, but rather would only make non-substantive changes, such as section renumbering. The proposed amendments to harmonize certain definitions with the industry standard would not change the scope of products currently subject to the DOE test procedure or energy conservation standards. And the proposed test procedure for measuring the power consumption of UPSs at no-load conditions would not be required for demonstrating compliance with standards. Therefore, the proposed amendments will not alter the measured energy efficiency or energy use of UPSs. Manufacturers will be able to rely on data generated under the current test procedure. Further, the proposed changes would not require the purchase of additional equipment or increase test burden, and consequently would not impact testing costs. If manufacturers elected to continue to make representations or begin making representations regarding UPS power consumption at no-load conditions, they may need to retest the standby power portion of the test procedure for their UPS model. DOE estimates that this retest would cost approximately $1,700 per unit if the test is conducted by a third-party lab and substantially less if done by the manufacturer themselves. However, as stated previously, any representations from such a retest would not be required for demonstrating compliance with standards.
DOE's established practice is to adopt relevant industry standards as DOE test procedures unless such methodology would be unduly burdensome to conduct or would not produce test results that reflect the energy efficiency, energy use, water use (as specified in EPCA), or estimated operating costs of that product during a representative average use cycle or period of use. Section 8(c) of appendix A of 10 CFR part 430 subpart C. In cases where the industry standard does not meet EPCA statutory criteria for test procedures, DOE will make modifications through the rulemaking process to these standards as the DOE test procedure.
The test procedure for UPSs at appendices Y and Y1 currently incorporates by reference IEC 62040-3 Ed. 2.0 regarding test setup, input and output power measurement, and the optional determination of UPS architecture. DOE is proposing to incorporate by reference the latest version of this industry standard (
DOE requests comment on the benefits and burdens of the proposed updates and additions to the industry standard referenced in the test procedure for UPSs.
EPCA prescribes that, if DOE amends a test procedure, all representations of energy efficiency and energy use, including those made on marketing materials and product labels, must be
If DOE were to publish an amended test procedure, EPCA provides an allowance for individual manufacturers to petition DOE for an extension of the 180-day period if the manufacturer may experience undue hardship in meeting the deadline. (42 U.S.C. 6293(c)(3)) To receive such an extension, petitions must be filed with DOE no later than 60 days before the end of the 180-day period and must detail how the manufacturer will experience undue hardship. (
DOE also recognizes that the publication of two separate final rules (the September 2022 Final Rule amending the test procedure for battery chargers that are not UPSs and a potential future test procedure final rule for UPSs, if DOE were to publish an amended test procedure) amending the battery charger test procedures at appendix Y could cause confusion as to what version of these appendices is required to be used when making a representation. A further complication is that the September 2022 Final Rule created a new test procedure at appendix Y1 that expanded the scope of the battery charger test method and established a new multi-metric approach for all battery chargers other than UPSs. Manufacturers will be required to continue to use the amended test procedure in appendix Y until the compliance date of amended energy conservation standards for battery chargers established by an energy conservation standard final rule at some point in the future. Only upon the compliance date of amended energy conservation standards for battery chargers will manufacturers be required to begin using the test procedure in appendix Y1.
The September 2022 Final Rule amended appendix Y requiring manufacturers of battery chargers to use this recently updated version beginning March 7, 2023. While the sections in appendix Y that apply to UPSs remained unchanged by the September 2022 Final Rule, UPS manufacturers are required to use the version of appendix Y, as modified by the September 2022 Final Rule, beginning on March 7, 2023. Because there are no differences in how a UPS is tested between the two versions of appendix Y, DOE tentatively concludes that it would be preferable to refer to the same version of the Appendix (as finalized by the September 2022 Final Rule) for testing both battery chargers and UPSs, even though the UPS testing provisions remain unchanged. DOE also concludes that presenting these various compliance dates and references to different versions of the appendices in a tabular format would be more effective. Accordingly, in this NOPR, DOE is proposing to update the notes section at the beginning of appendices Y and Y1 to include a table that clearly identifies the appropriate appendix reference and compliance dates for each product.
Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” as supplemented and reaffirmed by E.O. 13563, “Improving Regulation and Regulatory Review,” 76 FR 3821 (Jan. 21, 2011), requires agencies, to the extent permitted by law, to (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public. DOE emphasizes as well that E.O. 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs (“OIRA”) in the Office of Management and Budget (“OMB”) has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. For the reasons stated in the preamble, this proposed regulatory action is consistent with these principles.
Section 6(a) of E.O. 12866 also requires agencies to submit “significant regulatory actions” to OIRA for review. OIRA has determined that this proposed regulatory action does not constitute a “significant regulatory action” under section 3(f) of E.O. 12866. Accordingly, this action was not submitted to OIRA for review under E.O. 12866.
The Regulatory Flexibility Act (5 U.S.C. 601
For manufacturers of UPSs, the Small Business Administration (“SBA”) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule.
To estimate the number small businesses that manufacture UPSs impacted by this rulemaking, DOE conducted a survey using information from DOE's Compliance Certification Database and previous rulemakings. DOE used information from these
However, DOE has tentatively concluded that the proposed updates to DOE's test procedure for UPSs do not involve substantive changes to the test setup and methodology and will not pose any additional test burden or additional test costs for any UPS manufacturers, large or small.
Therefore, DOE tentatively concludes that the impacts of the test procedure amendments proposed in this NOPR would not have a “significant economic impact on a substantial number of small entities,” and that the preparation of an IRFA is not warranted. DOE will transmit the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).
Manufacturers of UPSs must certify to DOE that their products comply with any applicable energy conservation standards. To certify compliance, manufacturers must first obtain test data for their products according to the DOE test procedures, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including UPSs. (
DOE is not proposing to amend the certification or reporting requirements for UPSs in this NOPR. Instead, DOE may consider proposals to amend the certification requirements and reporting for UPSs under a separate rulemaking regarding appliance and equipment certification. DOE will address changes to OMB Control Number 1910-1400 at that time, as necessary.
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
In this NOPR, DOE proposes test procedure amendments that it expects will be used to develop and implement future energy conservation standards for UPSs. DOE has determined that this proposed rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (Aug. 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. The Executive order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.
Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity, (2) write regulations to minimize litigation, (3) provide a clear legal standard for affected conduct rather than a general standard, and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that executive agencies make every reasonable effort to ensure that the regulation (1) clearly specifies the preemptive effect, if any, (2) clearly specifies any effect on existing Federal law or regulation, (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction, (4) specifies the retroactive effect, if any, (5) adequately defines key terms, and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, the proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (“UMRA”) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Publc Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b))
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This proposed rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), that this proposed regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). Pursuant to OMB Memorandum M-19-15, Improving Implementation of the Information Quality Act (April 24, 2019), DOE published updated guidelines which are available at
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that (1) is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
The proposed regulatory action to amend the test procedure for measuring the energy efficiency of UPSs is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.
Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; “FEAA”) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (“FTC”) concerning the impact of the commercial or industry standards on competition.
The proposed modifications to the test procedure for UPSs would incorporate testing methods contained in certain sections of the following commercial standard: IEC 62040-3 Ed. 3.0. DOE has evaluated this standard and is unable to conclude whether it fully complies with the requirements of section 32(b) of the FEAA (
IEC 62040-3 Ed. 3.0, “Uninterruptible power systems (UPS)—Part 3: Method of specifying the performance and test requirements” is an industry-accepted test standard that specifies methods for measuring the efficiency of a UPS. The test procedure proposed in this NOPR updates all references from the previous edition (IEC 62040-3 Ed. 2.0) to this most current edition (IEC 62040-3 Ed. 3.0). IEC 62040-3 Ed. 3.0 is readily available from ANSI at
In this NOPR, DOE proposes to add a new section 0 (Incorporation by Reference) to both appendices Y and Y1 listing the applicable sections of IEC 62040-3 Ed. 3.0 that are referenced by the test procedure.
The time and date of the webinar meeting are listed in the
Any person who has an interest in the topics addressed in this document, or
DOE will designate a DOE official to preside at the webinar/public meeting and may also use a professional facilitator to aid discussion. The meeting will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in accordance with section 336 of EPCA (42 U.S.C. 6306). A court reporter will be present to record the proceedings and prepare a transcript. DOE reserves the right to schedule the order of presentations and to establish the procedures governing the conduct of the webinar/public meeting. There shall not be discussion of proprietary information, costs or prices, market share, or other commercial matters regulated by U.S. anti-trust laws. After the webinar/public meeting and until the end of the comment period, interested parties may submit further comments on the proceedings and any aspect of the rulemaking.
The webinar will be conducted in an informal, conference style. DOE will present a general overview of the topics addressed in this proposed rulemaking, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this proposed rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will permit, as time permits, other participants to comment briefly on any general statements.
At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this proposed rulemaking. The official conducting the webinar/public meeting will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the webinar/public meeting.
A transcript of the webinar will be included in the docket, which can be viewed as described in the
DOE will accept comments, data, and information regarding this proposed rule before or after the public meeting, but no later than the date provided in the
However, your contact information will be publicly viewable if you include it in the comment itself or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Otherwise, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
Do not submit to
DOE processes submissions made through
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via postal mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (“faxes”) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
(1) DOE requests comment on its proposal to harmonize its definition of a UPS with that of IEC 62040-3 Edition 3.0. Specifically, DOE requests comment on its tentative determination that such harmonization would not affect the current scope of the UPS test procedure.
(2) DOE requests comment on its proposal to update its definitions of THD, VFD UPS, VI UPS, and VFI UPC to harmonize with the IEC 62040-3 Ed 3.0 definitions.
(3) DOE requests comment on its proposal to incorporate by reference IEC 62040-3 Ed 3.0 and to update references in appendices Y and Y1 accordingly to reflect the renumbering of sections in IEC 62040-3 Ed 3.0.
(4) DOE requests comment on its proposal to not modify the existing loading points, weighting, or the overall efficiency metric in the current UPS test procedure.
(5) DOE requests feedback on its proposal to add a method for measuring the power consumption of UPSs at no-load as a test to be used as the basis for any representations of no-load power consumption.
(6) DOE requests comment on the benefits and burdens of the proposed updates and additions to the industry standard referenced in the test procedure for UPSs.
Additionally, DOE welcomes comments on other issues relevant to the conduct of this rulemaking that may not specifically be identified in this document.
The Secretary of Energy has approved publication of this notice of proposed rulemaking and announcement of public meeting.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
This document of the Department of Energy was signed on December 16, 2022, by Francisco Alejandro Moreno, Acting Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
For the reasons stated in the preamble, DOE is proposing to amend part 430 of Chapter II of Title 10, Code of Federal Regulations as set forth below:
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(p) * * *
(4) IEC Standard 62040-3 Ed. 3.0 (“IEC 62040-3 Ed. 3.0”)
The revisions and additions read as follows:
For all battery chargers, including UPSs, compliance with the relevant standard in § 430.32(z) or any representation must be based upon results generated under the corresponding appendix listed in the table below:
DOE incorporated by reference in § 430.3 the entire test standard for IEC 62040-3 Ed. 3.0. However, only enumerated provisions of this standard are applicable to this appendix, as follows. In cases in which there is a conflict, the language of the test procedure in this appendix takes precedence over the referenced test standard.
0.1 IEC 62040-3 Ed. 3.0:
(a) Section 3.5 Specified values;
(b) Section 3.5.49 total harmonic distortion
(c) 5, Electrical conditions, performance and declared values;
(d) Section 5, Electrical conditions, performance and declared values;
(e) Section 5.2, UPS input specification, as specified in section 2.27.2 of this appendix;
(f) Section 5.2.1—Conditions for normal mode of operation; Clause 5.2.1.a;
(g) Clause 5.2.1.b;
(h) Section 5.2.2—Conditions to be declared by the manufacturer; Clause 5.2.2.k;
(i) Clause 5.2.2.l;
(j) Clause 5.2.2.m;
(k) Section 5.3, UPS output specification; Section 5.3.2, Characteristics to be declared by the manufacturer; Clause 5.3.2.b;
(l) Clause 5.3.2.c;
(m) Clause 5.3.2.d;
(n) Clause 5.3.2.e;
(o) Section 5.3.4.2, Input dependency AAA;
(p) Section 6.2, Routine test procedure; Section 6.2.2, Electrical; Section 6.2.2.4, No load, as specified in section 4.3.3(c) of this appendix;
(q) Section 6.2.2.7, AC input failure, as specified in Note to section 2.27.1 of this appendix;
(r) Section 6.4, Type test procedure (electrical); Section 6.4.1, Input—AC input power compatibility; Section 6.4.1.2, Steady state input voltage tolerance and VI input independency, as specified in Note to section 2.27.3;
(s) Section 6.4.1.3, Combined input voltage/frequency tolerance and VFI input independency, as specified in Note to section 2.27.2 of this appendix;
(t) Annex G—AC input power failure—Test method
(u) Annex J—UPS efficiency and no load losses—Methods of measurement, as specified in sections 4.2.1, and 4.3.3 of this appendix.
0.2 [Reserved]
2.26.
2.27.
2.27.1.
VFD input dependency may be verified by performing the AC input failure test in section 6.2.2.7 of IEC 62040-3 Ed. 3.0 and observing that, at a minimum, the UPS switches from normal mode of operation to battery power while the input is interrupted.
2.27.2.
VFI input dependency may be verified by performing the combined input voltage/frequency tolerance and VFI input independency test in section 6.4.1.3 of IEC 62040-3 Ed. 3.0 respectively and observing that, at a minimum, the UPS produces an output voltage and frequency within the specified output range when the input voltage is varied by ±10% of the rated input voltage and the input frequency is varied by ±2% of the rated input frequency.
2.27.3. Voltage independent UPS or VI UPS means a UPS that protects the load as required for VFD and also from (a) under-voltage applied continuously to the input, and (b) over-voltage applied continuously to the input. The output voltage of a VI UPS shall remain within declared voltage limits (provided by voltage corrective functions, such as those arising from the use of active and/or passive circuits). The output voltage tolerance band shall be narrower than the input voltage tolerance band.
VI input dependency may be verified by performing the steady state input voltage tolerance test in section 6.4.1.2 of IEC 62040-3 Ed. 3.0 and ensuring that the UPS remains in normal mode with the output voltage within the specified output range when the input voltage is varied by ±10% of the rated input voltage.
4.2.1. General Setup
Configure the UPS according to Annex J.2 of IEC 62040-3 Ed. 3.0 with the following additional requirements:
4.3.3. Power Measurements and Efficiency Calculations
Measure input and output power of the UUT according to section J.3 of Annex J of IEC 62040-3 Ed. 3.0, or measure the input and output energy of the UUT for efficiency calculations with the following exceptions:
(c) For voluntary representations of no-load losses, measure the active power at the UPS input port with no load applied in accordance with section 6.2.2.4 of IEC 62040-3 Ed. 3.0.
The revisions and additions read as follows:
For all battery chargers, including UPSs, compliance with the relevant standard in § 430.32(z) or any representation must be based upon results generated under the corresponding appendix listed in the table below:
DOE incorporated by reference in § 430.3 the entire test standard for IEC 62040-3 Ed. 3.0. However, only enumerated provisions of this standard are applicable to this appendix, as follows. In cases in which there is a conflict, the language of the test procedure in this appendix takes precedence over the referenced test standard.
0.1 IEC 62040-3 Ed. 3.0:
(a) Section 3.5 Specified values;
(b) Section 3.5.49 total harmonic distortion;
(c) 5, Electrical conditions, performance and declared values;
(d) Section 5, Electrical conditions, performance and declared values;
(e) Section 5.2, UPS input specification, as specified in section 2.28.2 of this appendix;
(f) Section 5.2.1—Conditions for normal mode of operation; Clause 5.2.1.a;
(g) Clause 5.2.1.b;
(h) Section 5.2.2—Conditions to be declared by the manufacturer; Clause 5.2.2.k;
(i) Clause 5.2.2.l;
(j) Clause 5.2.2.m;
(k) Section 5.3, UPS output specification; Section 5.3.2, Characteristics to be declared by the manufacturer; Clause 5.3.2.b;
(l) Clause 5.3.2.c;
(m) Clause 5.3.2.d;
(n) Clause 5.3.2.e;
(o) Section 5.3.4.2, Input dependency AAA;
(p) Section 6.2, Routine test procedure; Section 6.2.2, Electrical; Section 6.2.2.4, No load, as specified in section 4.3.3(c) of this appendix;
(q) Section 6.2.2.7, AC input failure, as specified in Note to section 2.28.1 of this appendix;
(r) Section 6.4, Type test procedure (electrical); Section 6.4.1, Input—AC input power compatibility; Section 6.4.1.2, Steady state input voltage tolerance and VI input independency, as specified in Note to section 2.28.3 of this appendix;
(s) Section 6.4.1.3, Combined input voltage/frequency tolerance and VFI input independency, as specified in Note to section 2.28.2 of this appendix;
(t) Annex G—AC input power failure—Test method
(u) Annex J—UPS efficiency and no load losses—Methods of measurement, as specified in sections 4.2.1 and 4.3.2 of this appendix.
0.2 [Reserved]
2.27.
2.28.
2.28.1.
VFD input dependency may be verified by performing the AC input failure test in section 6.2.2.7 of IEC 62040-3 Ed. 3.0 and observing that, at a minimum, the UPS switches from normal mode of operation to battery power while the input is interrupted.
2.28.2.
VFI input dependency may be verified by performing the combined input voltage/frequency tolerance and VFI input independency test in section 6.4.1.3 of IEC 62040-3 Ed. 3.0 respectively and observing that, at a minimum, the UPS produces an output voltage and frequency within the specified output range when the input voltage is varied by ±10% of the rated input voltage and the input frequency is varied by ±2% of the rated input frequency.
2.28.3.
VI input dependency may be verified by performing the steady state input voltage tolerance test in section 6.4.1.2 of IEC 62040-3 Ed. 3.0 and ensuring that the UPS remains in normal mode with the output voltage within the specified output range when the input voltage is varied by ±10% of the rated input voltage.
4.2.1. General Setup
Configure the UPS according to Annex J.2 of IEC 62040-3 Ed. 3.0 with the following additional requirements:
4.3.3. Power Measurements and Efficiency Calculations
Measure input and output power of the UUT according to section J.3 of Annex J of IEC 62040-3 Ed. 3.0, or measure the input and output energy of the UUT for efficiency calculations with the following exceptions:
(c) For voluntary representations of no-load losses, measure the active power at the UPS input port with no load applied in accordance with section 6.2.2.4 of IEC 62040-3 Ed. 3.0.
Environmental Protection Agency (EPA).
Proposed rule.
The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants (Lime Manufacturing NESHAP), as required by the Clean Air Act (CAA). To ensure that all emissions of HAP from sources in the source category are regulated, the EPA is proposing hazardous air pollutant (HAP) emissions standards for the following pollutants: hydrogen chloride (HCl), mercury, total hydrocarbon (THC) as a surrogate for organic HAP, and dioxin/furans (D/F).
Comments must be received on or before February 21, 2023. Under the Paperwork Reduction Act (PRA), 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 February 6, 2023.
You may send comments, identified by Docket ID No. EPA-HQ-OAR-2017-0015, by any of the following methods:
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•
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•
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For questions about this proposed action, contact Brian Storey, Sector Policies and Programs Division (Mail Code D243-04), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-1103; fax number: (919) 541-4991; and email address:
If a public hearing is requested, the EPA will begin pre-registering speakers for the hearing upon publication of this document in the
The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule.
Each commenter will have 4 minutes to provide oral testimony. The EPA encourages commenters to submit a copy of their oral testimony as written comments to the rulemaking docket.
The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.
Please note that any updates made to any aspect of the hearing will be posted online at
If you require the services of a translator or special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by January 12, 2023. The EPA may not be able to arrange accommodations without advanced notice.
The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is
The
Our preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol (FTP), or other online file sharing services (
Table 1 of this preamble lists the NESHAP and associated regulated industrial source category that is the subject of this proposal. Table 1 is not intended to be exhaustive, but rather provides a guide for readers regarding the entities that this proposed action is likely to affect. The proposed standards, once promulgated, will be directly applicable to the affected sources. Federal, state, local, and tribal government entities would not be affected by this proposed action. As defined in the Initial List of Categories of Sources Under Section112(c)(1) of the Clean Air Act Amendments of 1990 (57 FR 31576, July 16, 1992) and Documentation for Developing the Initial Source Category List, Final Report (EPA-450/3-91-030, July 1992), the Lime Manufacturing source category is “any facility engaged in producing high calcium lime, dolomitic lime, and dead-burned dolomite.” However, lime manufacturing plants located at pulp and paper mills or at beet sugar factories are not included in the source category (69 FR 394, 397, January 5, 2004).
In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at
On July 24, 2020, the EPA took final action on the risk and technology review required by Clean Air Act (CAA) sections 112(d)(6) and (f)(2) for the NESHAP for Lime Manufacturing Plants (2020 RTR).
In setting standards for major source categories under CAA 112(d), EPA has the obligation to address all HAP listed under CAA 112(b).
Emissions data collected for the 2020 RTR from the exhaust stack of existing lime kilns in the source category indicated the following unregulated pollutants were present: HCl, mercury, organic HAP (which we are proposing to regulate using THC as a surrogate), and D/F. Therefore, the EPA is proposing amendments establishing standards that reflect maximum achievable control technology (MACT) for these four pollutants emitted by the source category, pursuant to CAA sections 112(d)(2) and (3).
The EPA promulgated the Lime Manufacturing NESHAP on January 5, 2004 (69 FR 394). The standards are codified at 40 CFR part 63, subpart AAAAA. The lime manufacturing industry consists of facilities that use a lime kiln to produce lime product from limestone by calcination. The source category covered by this MACT standard currently includes 35 facilities.
As promulgated in 2004, the current Lime Manufacturing NESHAP regulates HAP emissions from all new and existing lime manufacturing plants that are major sources, co-located with major sources, or are part of major sources. However, lime manufacturing plants located at pulp and paper mills or at beet sugar factories are not subject to the NESHAP.
The Lime Manufacturing NESHAP defines the affected source as each lime kiln and its associated cooler and each individual processed stone handling (PSH) operations system. The PSH operations system includes all equipment associated with PSH operations beginning at the process stone storage bin(s) or open storage pile(s) and ending where the process stone is fed into the kiln. It includes man-made process stone storage bins (but not open process stone storage piles), conveying system transfer points, bulk loading or unloading systems,
The current Lime Manufacturing NESHAP established particulate matter (PM) emission limits for lime kilns, coolers, and PSH operations with stacks. The NESHAP also established opacity limits for kilns equipped with electrostatic precipitators (ESP) and fabric filters (FF) and scrubber liquid flow limits for kilns equipped with wet scrubbers. Particulate matter serves as a surrogate for the non-mercury metal HAP. The NESHAP also regulates opacity or visible emissions from most of the PSH operations, with opacity also serving as a surrogate for HAP metals.
The PM emission limit for existing kilns and coolers is 0.12 pounds PM per ton of stone feed (lb/tsf) for kilns using dry air pollution control systems prior to January 5, 2004. Existing kilns that have installed and are operating wet scrubbers prior to January 5, 2004, must meet an emission limit of 0.60 lb/tsf. Kilns which meet the criteria for the 0.60 lb/tsf emission limit must continue to use a wet scrubber for PM emission control in order to be eligible to meet the 0.60 lb/tsf limit. If at any time such a kiln switches to a dry control, they would become subject to the 0.12 lb/tsf emission limit, regardless of the type of control device used in the future. The PM emission limit for all new kilns and lime coolers is 0.10 lb/tsf. As a compliance option, these emission limits (except for the 0.60 lb/tsf limit) may be applied to the combined emissions of all the kilns and coolers at the lime manufacturing plant. If the lime manufacturing plant has both new and existing kilns and coolers, then the emission limit would be an average of the existing and new kiln PM emissions limits, weighted by the annual actual production rates of the individual kilns, except that no new kiln may exceed the PM emission level of 0.10 lb/tsf. Kilns that are required to meet a 0.60 lb/tsf emission limit must meet that limit individually and may not be included in any averaging calculations.
Emissions from PSH operations that are vented through a stack are subject to a limit of 0.05 grams PM per dry standard cubic meter (g/dscm) and 7 percent opacity. Stack emissions from PSH operations that are controlled by wet scrubbers are subject to the 0.05 g PM/dscm limit but not subject to the opacity limit. Fugitive emissions from PSH operations are subject to a 10 percent opacity limit.
For each building enclosing any PSH operation, each of the affected PSH operations in the building must comply individually with the applicable PM and opacity emission limitations. Otherwise, there must be no visible emissions from the building, except from a vent, and the building's vent emissions must not exceed 0.05 g/dscm and 7 percent opacity. For each fabric filter that controls emissions from only an individual, enclosed processed stone storage bin, the opacity must not exceed 7 percent. For each set of multiple processed stone storage bins with combined stack emissions, emissions must not exceed 0.05 g/dscm and 7 percent opacity. The current Lime Manufacturing NESHAP does not allow averaging of PSH operations.
The 2020 amendments finalized the residual risk and technology review (RTR) conducted for the Lime Manufacturing NESHAP. The RTR found that the risk associated with air emissions from lime manufacturing was acceptable and that the current NESHAP provides an ample margin of safety to protect public health. The EPA determined that there were no developments in practices, processes, or control technologies that would warrant revisions to the standards. In addition, the 2020 amendments addressed periods of startup, shutdown, and malfunction (SSM) by removing any exemptions during SSM operations. Lastly, the 2020 amendments included provisions requiring electronic reporting.
During the development of 40 CFR part 63, subpart AAAAA, the EPA collected information on the emissions, operations, and location of lime manufacturing plants. Since this information was collected prior to the 2004 promulgation of 40 CFR part 63, subpart AAAAA, the EPA prepared a questionnaire in 2017 to collect updated information on the location and number of lime kilns, types and quantities of emissions, annual operating hours, types and quantities of fuels burned, and information on air pollution control devices and emission points. Nine companies completed the 2017 questionnaire for which they reported data for 32 of 35 major source facilities.
In this action, the EPA used the emissions data collected from the 2017 questionnaire to develop MACT standards for four unregulated pollutants (HCl, mercury, THC, D/F). In addition, supplemental information was provided by industry stakeholders on the mercury content of the raw material feed to the lime kiln, the types of lime kiln designs and their operations, and the types of lime produced. The data collected and used in this action are provided in the docket. In addition, the data collection and analysis of this action are described in detail in the document, “Proposed Maximum Achievable Control Technology (MACT) Floor Analysis for the Lime Manufacturing Plant Industry,” located in the docket (Docket ID No. EPA-HQ-OAR-2017-0015).
While evaluating the lime manufacturing source category and emissions data collected in support of the 2020 RTR, we identified several HAP which are not currently regulated by the Lime Manufacturing NESHAP. These HAP include HCl, mercury, and D/F. Additionally, multiple HAP that are classified as “organic HAP” were identified. The EPA has a “clear statutory obligation to set emissions standards for each listed HAP”.
In response to the 2017 questionnaire, we received HCl emissions data that EPA did not have when we developed the 2004 NESHAP. Therefore, we are proposing a standard pursuant to CAA section 112(d)(2) and (d)(3), as described further in section IV.A.1 of this preamble.
The 2004 NESHAP specified emissions limits for particulate metal HAP (
In response to the 2017 questionnaire, we received THC emissions data that EPA did not have when we developed the 2004 NESHAP. The THC data
Lastly, the 2017 questionnaire identified the potential for sources in the lime manufacturing source category to emit congeners of D/F; therefore, we are proposing a standard for D/F pursuant to CAA section 112(d)(2) and (d)(3), as described in detail in section IV.A.4 of this preamble.
The “MACT floor” for existing sources is calculated based on the average performance of the best-performing units in each category or subcategory and on a consideration of the variability of HAP emissions from these units. The MACT floor for new sources is based on the single best-performing source, with a similar consideration of variability. The MACT floor for new sources cannot be less stringent than the emissions performance that is achieved in practice by the best-controlled similar source. To account for variability in the lime manufacturing operations and resulting emissions, we calculated the MACT floors using the 99 percent Upper Predictive Limit (UPL) using available stack test data.
The UPL approach addresses variability of emissions data from the best-performing source or sources in setting MACT standards. The UPL also accounts for uncertainty associated with emission values in a dataset, which can be influenced by components such as the number of samples available for developing MACT standards and the number of samples that will be collected to assess compliance with the emission limit. The UPL approach has been used in many environmental science applications. As explained in more detail in the UPL Memo cited above, the EPA uses the UPL approach to reasonably estimate the emissions performance of the best-performing source or sources to establish MACT floor standards.
In addition, the EPA must examine more stringent “beyond-the-floor” regulatory options to determine MACT. Unlike the floor minimum stringency requirements, the EPA must consider various impacts of the more stringent regulatory options in determining whether MACT standards are to reflect beyond-the-floor requirements. If the EPA concludes that the more stringent regulatory options have unreasonable impacts, the EPA selects the MACT floor as MACT. However, if the EPA concludes that impacts associated with beyond-the-floor levels of control are reasonable in light of additional emissions reductions achieved, the EPA selects those levels as MACT.
Data submitted to the EPA for the 2017 questionnaire included air emissions test results from 32 of the 35 lime manufacturing facilities in the source category. From the questionnaire responses, we also noted the types of kilns in use and types of lime being produced at the time of testing. The types of kilns used by the lime manufacturing industry include straight rotary kilns (SR), preheater rotary kilns (PR), vertical kilns (VK), and fluidized bed kilns (FB). The types of lime produced include refractory dead burned dolomitic lime (DB), dolomitic quick lime (DL), and high-calcium quick lime (QL).
The 2017 data included the results of stack testing 30 kiln exhaust stacks for the presence of HCl, using EPA Methods 320 and 321. Data collected using the test method ASTM D6735-01 “Standard Test Method for Measurement of Gaseous Chlorides and Fluorides from Mineral Calcining Exhaust Sources—Impinger Method” were found to be invalid, based on the fact that the test method is no longer an active ASTM method. The ASTM method was never revised to reflect the change in probe and filter temperature as were included in EPA Method 26A. Because of this, the ASTM method is run hot enough to evaporate amonium chloride from the sample and bias the HCl results high. Additionally, we evaluated the types of kilns and lime produced for which we had data. From our discussions with industry representatives, and our review of the HCl emissions data, we found that the configuration of the different types of kilns (
To account for variability in the lime manufacturing operations and resulting emissions, the stack test data were used to calculate the HCl MACT floor limits based on the 99 percent UPL. In some instances, subcategorization resulted in limited datasets, and a single dataset was used to calculate both existing and new source HCl MACT floor limits. In these instances, the existing HCl MACT floor limit equals the new source HCl MACT floor limit. The HCl MACT floor limits were calculated based on concentration, in units of parts per million by volume, dry, corrected to 7 percent oxygen (ppmvd @7 percent O
We did not have emissions data from fluidized bed kilns, and after discussions with industry representatives, we understand that there are no fluidized bed kilns located at any major source facilities subject to the Lime Manufacturing NESHAP. There are fluidized bed kilns in use at area sources, but area sources are not subject to the Lime Manufacturing NESHAP. In addition, the 2017 questionnaire provided emissions data for vertical kilns producing high-calcium quick lime only. We have set the new and existing HCl MACT floor limits for vertical kilns producing dolomitic lime and dead burned dolomitic lime equal to the MACT floor for high-calcium quick lime. Lastly, we have set the MACT floor for preheater rotary kilns producing dead burned dolomitic lime, equal to those preheater rotary kilns producing dolomitic quick lime.
The EPA then compared the emission rates estimated in the 2020 RTR to the HCl MACT floor limits to determine the number of kilns in the source category that would require additional air pollution control devices (APCD) to meet the HCl MACT floor limit. We found that out of 96 existing kilns, 55 kilns would require additional controls to comply with the proposed HCl MACT floor limit. From this information, we evaluated the effectiveness of potential APCD for removal of HCl from kiln exhaust gas streams and found that dry sorbent injection has an estimated 98 percent removal efficiency for HCl.
Dry sorbent injection (DSI) removes HCl and other acid gases using a powdered alkali sorbent injected into the exhaust gas ductwork where it then reacts with the HCl in the exhaust stream. The sorbent solids are then collected in either an ESP or baghouse. The most commonly used sodium-based sorbent is Trona, typically used in situations where the goal is to remove sulfur dioxide and/or acid gases from an exhaust gas. Hydrated lime can be used in processes, such as lime manufacturing, where the goal is to reduce acid gas emissions only.
Applying the removal efficiency of DSI controls using hydrated lime to each of the 55 kilns identified would reduce HCl emissions from these sources to below the HCl MACT floor limit. This would result in a combined reduction of 1,163 tons of HCl per year from these sources. The total capital investment to retrofit 55 existing kilns with DSI controls are estimated to be $5,400,000 and the total annual costs are estimated to be $5,200,000 per year. The cost per ton of HCl removed is estimated to be $4,500 per ton of HCl removed.
We also conducted a beyond-the-floor analysis, where we evaluated whether existing kilns would be able to comply with the new source HCl MACT floor limits. We found that of the 96 existing kilns in the source category, 74 kilns would require a DSI as control in order to meet the new source HCl MACT floor limit. The estimated reduction in HCl emissions from a beyond-the-floor HCl limit is 1,754 tons of HCl per year. The estimated incremental reduction, where we compare the existing source beyond-the-floor limit to the existing source MACT floor limit, is 591 tons of HCl per year. We estimate the total capital investment to be $9,400,000 and total annual costs to be $7,500,000 per year for beyond-the-floor limits. This results in a cost effectiveness of approximately $4,300 per ton of HCl removal. We do not consider the control costs to be reasonable and therefore are not proposing a beyond-the-floor standard for HCl.
As part of our beyond-the-floor analysis, we typically identify control techniques that have the ability to achieve an emissions limit more stringent than the MACT floor. No techniques were identified that would achieve HAP reductions greater than the new source floors for the HCl subcategories. Therefore, the EPA is not proposing a beyond-the-floor HCl limit for new sources in this proposed rule.
A detailed description of the analysis of HCl emissions, the controls necessary to reduce HCl emissions, and the cost of these controls are included in the document, “Proposed Maximum Achievable Control Technology (MACT) Floor Analysis for the Lime Manufacturing Plants Industry”, located in the docket (Docket ID No. EPA-HQ-OAR-2017-0015).
The 2017 data included the results of stack testing 21 kiln exhaust stacks for the presence of mercury, using EPA Methods 29 and 30B. As with HCl, we evaluated the types of kilns and lime produced for which we had data. From our discussions with industry representatives and our review of the mercury emissions data, we found that the differences in residence time of the raw materials within the heating zone of the kiln during the production of the different types of lime produced warranted subcategorization by the three types of lime produced (
To account for variability in the lime manufacturing operations and resulting emissions, the stack test data were used to calculate the mercury MACT floor limits based on the 99 percent UPL. The mercury MACT floor limits were calculated in units of pounds of pollutant per million tons of lime produced (lb/MMton lime produced).
The EPA compared the mercury emission rates estimated in the 2020 RTR to the calculated MACT floor limits to determine the number of kilns in the source category that would require additional APCD to meet the mercury MACT floor limit. We found that out of 96 existing kilns, 75 kilns would require additional controls to comply with the calculated mercury MACT floor limits. We evaluated the effectiveness of potential APCD for removal of mercury from kiln exhaust gas streams and found
Similar to the discussion on the mechanism of DSI controls, ACI removes gaseous mercury from an exhaust gas stream by injecting activated carbon into the exhaust gas ductwork where it then adsorbs the gaseous mercury. The mercury-laden carbon is then collected in either an ESP or baghouse as particulate.
Applying the removal efficiency of ACI controls to each of the 75 kilns identified would reduce mercury emissions from these sources to below the mercury MACT floor limits. This would result in a combined reduction of approximately 488.5 pounds, or 0.24 tons of mercury per year from these sources. The total capital investment to retrofit 75 existing kilns with ACI controls are estimated to be $7,300,000 and the total annual costs are estimated to be $18,900,000 per year. To comply with the mercury MACT floor limits, the cost per ton of mercury removed is estimated to be $39,000 per pound of mercury removed. The use of ACI controls also provides removal of THC and D/F, as discussed in sections IV.A.3 and IV.A.4 of this preamble.
For existing sources in each of the mercury subcategories we found it is cost-effective to set emissions limits that go beyond the calculated MACT floor limits. In the case of the quick lime and dolomitic lime subcategories, the new and existing MACT floor limits were similar in value (24.94 lb/MMton for new sources, and 25.58 lb/MMton for existing sources), such that with the suggested controls the existing sources would be able to comply with the new source standard with no additional costs. We therefore set the existing emission limit equal to the new source emission limit. For the dead burned dolomitic lime subcategory, we evaluated the use of APCD to control mercury from these sources and estimate that the cost effectiveness ($/lb) associated with the installation of ACI controls is $16,969 per pound of mercury removed. This cost-effectiveness value is well within the range that we have determined to be cost-effective for mercury in other rules, and therefore for the dead burned dolomitic lime subcategory we are proposing beyond-the-floor limits for new and existing sources based on the use of these controls. A more detailed discussion of the APCD selected to remove mercury, and the beyond-the-floor analysis is provided below.
A summary of the proposed subcategories, and the associated proposed mercury MACT floor limits in units of lb/MMton of lime produced for new and existing lime manufacturing sources is included as Table 3.
In addition to the pooled variability factor in the UPL calculation, the EPA evaluated the possibility of considering the variability in mercury content of the raw material feed over the life of a quarry, consistent with the approach followed in other NESHAPs including the Portland Cement Manufacturing NESHAP (74 FR 21142), and the Brick and Structural Clay Products NESHAP (79 FR 75634). The pooled variability factor in the UPL accounts for short term variability in air emissions, and an “intra-quarry variability” (IQV) factor would account for variability in the mercury content of the raw material over the long-term life of the quarry.
Industry stakeholders provided the EPA with data from two separate lime manufacturing facilities, both of which were included in the mercury MACT floor calculations. At the first facility, the mercury content of the kiln feed was sampled, and the results tabulated. At the second facility the quarry was sampled, as well as the kiln feed, and the results tabulated. The EPA believes that from the kiln feed data provided, and the quarry sample data provided, the kiln feed data is more representative of the variability. This is based primarily on the fact that the mined quarry stone is first stored in open storage piles, where it can then mix with stone collected from the quarry over time. Therefore, the kiln feed represents a more homogenized sample of the storage pile and is more representative of the raw material fed to the lime kiln. The EPA considered the mercury content data of the kiln feed material of the two facilities and determined that we did not have enough data to establish an IQV factor. Additionally, from the data that was provided, the calculated IQV had little effect on the mercury MACT floor limits. A detailed description of this analysis is provided in the docket.
In the beyond-the-floor analysis for the quick lime and dolomitic lime subcategory, we evaluated whether existing kilns would be able to comply with the new source mercury MACT floor limit. Because facilities will require ACI controls to reduce mercury emissions in order to comply with the proposed limits, existing sources would be able to also meet the new source limit without any additional costs. Therefore, we are proposing to set the existing source limit equal to the new source limit for the quick lime and dolomitic lime subcategory. For the dead burned dolomitic lime subcategory, we performed a beyond-the-floor analysis where we analyzed the effects of ACI controls versus the costs associated with installation and maintenance of ACI controls. We determined that the cost for new and existing sources in the dead burned dolomitic lime subcategory to install and operate ACI controls to reduce their mercury emissions beyond the calculated MACT floor were reasonable. As part of this analysis, we considered the use of ACI to control THC emissions (discussed in section IV.A.3 of this preamble). Because facilities will incur costs associated with controlling THC emissions, we did not double-count those costs when assessing the dead burned dolomitic lime subcategory, where ACI controls are used to reduce their mercury emissions beyond the calculated MACT floor. The total annual costs for the dead burned dolomitic lime subcategory to go beyond the MACT floor by installing ACI controls is, therefore, zero, due to these sources already installing ACI controls to comply with the THC MACT floor limits.
No control techniques were identified that would achieve mercury reductions
A detailed description of the analysis of mercury emissions, the controls necessary to reduce mercury emissions, and the cost of these controls are included in the document, “Proposed Maximum Achievable Control Technology (MACT) Floor Analysis for the Lime Manufacturing Plant Industry”, located in the docket (Docket ID No. EPA-HQ-OAR-2017-0015).
The 2017 data included the results of testing 34 kiln exhaust stacks for the presence of THC, using EPA Method 25A. In addition, industry stakeholders provided emissions testing data that identified nine non-dioxin organic HAP. These included the pollutants formaldehyde, benzene, toluene, styrene, o-, m-, and p-xylenes, acetaldehyde, and naphthalene. The EPA evaluated the organic HAP data and compared the list of nine pollutants with the THC test data which identified the nine, but also identified additional organic HAP pollutants in the analyses including the pollutants acrolein, carbon disulfide, ethyl benzene, and vinyl chloride. Based on the EPA's assessment of the available test data, the EPA concludes that compliance with a THC emissions standard would, therefore, limit and control emissions of total organic HAP being emitted from the lime manufacturing process. Therefore, the EPA is proposing to establish standards for THC as a surrogate for organic HAP. We also evaluated the types of kilns and lime produced for which we had data and determined that subcategorization by kiln type or lime produced was not warranted.
To account for variability in the lime manufacturing operations and resulting emissions, the stack test data were used to calculate the THC MACT floor limits based on the 99 percent UPL. The THC MACT floor limits were calculated based on concentration as propane, in units of ppmvd, corrected to 7 percent O
The EPA compared the emission rates estimated in the 2020 RTR to the proposed THC MACT floor limits to determine the number of kilns in the source category that would require additional APCD to meet the THC MACT floor limit. We found that out of 96 existing kilns, 78 kilns would require additional controls to comply with the proposed THC MACT floor limit. From this information, we evaluated the potential effectiveness of APCD for removal of THC from kiln exhaust gas streams and found that an ACI has an estimated 60 percent THC removal efficiency. Of the 78 sources in the category, we determined that 74 sources could comply with the THC MACT floor limit using ACI, but four sources would be required to operate additional or alternative APCD to comply with the THC MACT floor limit. We therefore evaluated the use of a regenerative thermal oxidizer (RTO), which has a 99 percent THC removal efficiency. Based on our evaluation, the four sources would be required to install an RTO instead of ACI controls in order to comply with the proposed THC MACT floor limit.
As previously discussed, and similar to the control of mercury, ACI systems control THC emissions by injecting activated carbon into the exhaust gas stream. The activated carbon reacts with the organic HAP to form a reactant which can then be removed by an ESP or baghouse as particulate.
An RTO uses a high-density media to preheat the exhaust gas stream and to start the oxidation process. The gas then enters a combustion chamber, where high temperatures complete the oxidation process. Heat from the combustion chamber is then routed back to the high-density media chamber and provides the heat to preheat the incoming gas stream.
Applying the removal efficiency of ACI controls, and in four cases the removal efficiency of an RTO, to each of the 78 kilns previously identified, would reduce THC emissions from these sources to below the proposed THC MACT floor limit. This would result in a combined reduction of approximately 570 tons of THC per year from these sources. When calculating the capital investment and annual costs associated with controlling THC emissions, we also considered those facilities that would have to install ACI to control mercury emissions, as previously discussed in this preamble. The total capital investment to retrofit 78 existing kilns with the appropriate THC controls is estimated to be $14,600,000 and the total annual costs are estimated to be $7,800,000 per year. The cost per ton of THC removed is estimated to be $13,800 per ton of THC removed.
We also conducted a beyond-the-floor analysis where we evaluated whether existing kilns would be able to comply with the new source THC MACT floor limits. We found that of the 96 existing kilns in the source category, 36 kilns would require ACI as control and 47 would require an RTO as control, in order to meet the new source THC MACT floor limit. The estimated reduction in THC emissions from a beyond-the-floor THC limit is approximately 780 tons of THC per year. The incremental reduction, where we compare the existing source beyond-the-floor limit to the existing source MACT floor limit, is estimated to be approximately 210 tons of THC per year. We estimate the total capital investment to be $160,000,000 and total annual costs $52,000,000 per year for beyond-the-floor limits. This results in a cost effectiveness of $67,000 per ton of THC reduction.
We also assessed the costs associated with the use of RTO to control THC beyond the MACT floor limit. As previously stated, of the 96 existing kilns in the source category, 4 kilns will be required to install an RTO to comply with the THC MACT floor limit. The total capital investment for the remaining 92 existing kilns to install an RTO to go beyond-the-floor for THC would be $300,000,000, and the total annual cost is estimated as $99,000,000. We did not consider the costs of either of these beyond-the-floor options to be reasonable and therefore are not proposing a beyond-the-floor standard for THC.
A detailed description of the analysis of THC emissions, the controls necessary to reduce THC emissions, and the cost of these controls are included in the document, “Proposed Maximum Achievable Control Technology (MACT) Floor Analysis for the Lime Manufacturing Plant Industry”, located in the docket (Docket ID No. EPA-HQ-OAR-2017-0015).
The 2017 data included the results of testing seven kiln exhaust stacks for the presence of D/F congeners using EPA Method 23. After review of the test reports, the EPA determined that five of the seven reports were not valid because each report only performed a 1-run test, which cannot be used to set a MACT floor limit. Two of the seven reports included valid 3-run tests. To account for variability in the lime manufacturing operations and resulting D/F emissions, the data were used to calculate the D/F MACT floor based on the 99 percent UPL. The 2017 D/F data included some congeners reported as below detection level (BDL). Because of this we followed the guidance of the June 5, 2014, memorandum from Steffan Johnson titled, “Determination of `non‐detect' from EPA Method 29 (multi‐metals) and EPA Method 23 (dioxin/furan) test data when evaluating the setting of MACT floors versus establishing work practice standards” (Docket ID No. EPA-HQ-OAR-2017-0015), which provides guidance on using detection limits as an indicator of the measurable presence of a given pollutant, specifically where multi-component samples, such as with D/F congeners, are the pollutants of concern. Additionally, we reviewed the December 13, 2011, memorandum from Peter Westlin and Ray Merrill titled “Data and procedure for handling below detection level data in analyzing various pollutant emissions databases for MACT and RTR emissions limits” (Docket ID No. EPA-HQ-OAR-2017-0015), which describes the procedure for handling below detection level (BDL) data and developing representative detection level (RDL) data when setting MACT emission limits. In accordance with these guidance documents, the new and existing UPL for D/F were compared to the emission limit value determined to be equivalent to 3 times the RDL (3×RDL)
The EPA recognizes that these proposed limits are based on a limited D/F emissions dataset. The EPA will accept any additional D/F test data relevant to lime manufacturing operations during the public comment period.
The EPA then compared the emission rates estimated in the 2020 RTR to the proposed D/F MACT floor limits to determine the number of kilns in the source category that would require additional APCD to meet the MACT floor limit. We found that 1 of the 96 kilns in the source category would require additional controls in order to be able to comply with the proposed D/F MACT floor limit. From this information, we evaluated the potential effectiveness of APCD for removal of D/F from kiln exhaust gas streams and found that an ACI has an estimated 85 percent D/F removal efficiency. The total capital investment for the use of ACI as control of D/F is estimated to be $98,000, and the total annual cost is estimated to be $251,000.
We did not perform a beyond-the-floor analysis for D/F. The proposed limit is based on the detection limit of the method and represents the lowest concentration of D/F that can be measured; therefore, no further emissions reduction can be achieved that is measurable.
A detailed description of the analysis of D/F emissions, the comparison with the 3×RDL value, the controls necessary to reduce D/F emissions, and the cost of these controls are included in the document, “Proposed Maximum Achievable Control Technology (MACT) Floor Analysis for the Lime Manufacturing Plants Industry”, located in the docket (Docket ID No. EPA-HQ-OAR-2017-0015).
The proposed emission limits for new and existing sources in the Lime Manufacturing NESHAP are summarized in Table 6.
We are proposing, based on the new and existing source limits for lime kilns, that new sources demonstrate initial compliance within 180 days after start-up, and existing sources demonstrate initial compliance within 3 years after the promulgation of the final rule. We are proposing that the initial performance tests to demonstrate compliance with the MACT standards of Table 6 of this preamble are conducted using the methods identified in Table 7.
Additionally, consistent with the existing performance testing requirements of the Lime Manufacturing NESHAP (40 CFR 63.7111), subsequent performance testing will be required every 5 years, using the methods identified in Table 7.
Under this proposal, continuous compliance with the emission limits would be demonstrated through control device parameter monitoring coupled with periodic emissions testing described above.
In addition to the parametric monitoring currently specified in the rule for wet scrubbers and baghouses (40 CFR 63.7113), we are proposing to add to Table 3 of the NESHAP the following parameter monitoring requirements for the types of APCDs that we expect would be used to comply with the standards:
• For DSI, monitor and record the sorbent injection flow rate, and gas flow rate.
• For ACI, monitor and record the activated carbon injection rate, and the gas flow rate.
• For RTO, monitor and record the combustion chamber temperature.
The operating limits for these parameters are set consistent with the existing provisions of 40 CFR 63.7112(j), as the average of the three test run averages during the performance test. In addition, consistent with NESHAP general provisions, a source owner will be required to operate and maintain the source, its air pollution control equipment, and its monitoring equipment in a manner consistent with safety and good air pollution control practices for minimizing emissions, to include operating and maintaining equipment in accordance with manufacturer's recommendations. Owners will be required to prepare and keep records of calibration and accuracy checks of the continuous parameter monitoring system (CPMS) to document proper operation and maintenance of the monitoring system.
Under this proposal, and consistent with existing requirements in the Lime Manufacturing NESHAP, a source owner will be required to submit semi-annual compliance summary reports which document both compliance with the requirements of the Lime Manufacturing NESHAP and any deviations from compliance with any of those requirements.
Owners and operators would be required to maintain the records specified by 40 CFR 63.10 and, in addition, would be required to maintain records of all inspection and monitoring data, in accordance with the Lime Manufacturing NESHAP (40 CFR 63.7132).
We are proposing to update the electronic reporting requirements found in 40 CFR 63.7131(g) and 40 CFR 63.7131(h)(3) to reflect new procedures for reporting CBI. The update provides an email address that source owners and operators can electronically mail CBI to the OAQPS CBI Office when submitting compliance reports.
Amendments to the Lime Manufacturing NESHAP proposed in this rulemaking for adoption under CAA section 112(d)(2) and (3) are subject to the compliance deadlines outlined in the CAA under section 112(i). For existing sources, CAA section 112(i)(3) provides there shall be compliance “as expeditiously as practicable, but in no event later than 3 years after the effective date of such standard” subject to certain exemptions further detailed in the statute.
The EPA projects that many existing sources would need to install add-on controls to comply with the proposed limits. These sources would require
All affected facilities would have to continue to meet the current provisions of 40 CFR part 63, subpart AAAAA until the applicable compliance date of the amended rule. The final action is not a “major rule” as defined by 5 U.S.C. 804(2), so the effective date of the final rule will be the promulgation date as specified in CAA section 112(d)(10).
For all affected sources that commence construction or reconstruction on or before January 5, 2023, we are proposing that it is necessary to provide 3 years after the effective date of the final rule (or upon startup, whichever is later) for owners and operators to comply with the provisions of this action. For all affected sources that commenced construction or reconstruction after January 5, 2023, we are proposing that owners and operators comply with the provisions by the effective date of the final rule (or upon startup, whichever is later).
We solicit comment on these proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended provisions and the time needed to make the adjustments for compliance with any of the revised provisions. We note that information provided may result in changes to the proposed compliance dates.
As previously indicated, there are currently 35 major sources subject to the Lime Manufacturing NESHAP that are operating in the United States. An affected source under the NESHAP is the owner or operator of a lime manufacturing plant that is a major source, or that is located at, or is a part of, a major source of HAP emissions, unless the lime manufacturing plant is located at a kraft pulp mill, soda pulp mill, sulfite pulp mill, beet sugar manufacturing plant, or only processes sludge containing calcium carbonate from water softening processes. A lime manufacturing plant is an establishment engaged in the manufacture of lime products (calcium oxide, calcium oxide with magnesium oxide, or dead burned dolomite) by calcination of limestone, dolomite, shells, or other calcareous substances. A major source of HAP is a plant site that emits or has the potential to emit any single HAP at a rate of 9.07 megagrams (10 tons) or more, or any combination of HAP at a rate of 22.68 megagrams (25 tons) or more per year from all emission sources at the plant site.
The Lime Manufacturing NESHAP applies to each existing or new lime kiln and their associated cooler(s). In addition, the NESHAP applies to each PSH operation located at the plant. This includes storage bins, conveying systems and transfer points, bulk loading and unloading operations, screening operations, surge bins, and bucket elevators.
This action proposes first-time standards for HCl, mercury, THC, and D/F that will limit emissions and require, in some cases, the installation of additional controls at lime manufacturing plants at major sources. We estimate that the lime manufacturing industry will comply with the D/F standards without the addition of controls. For HCl, mercury, and THC, installation of controls will result in a combined reduction of total HAP of 1,730 tons of HAP per year (tpy). Specifically, installation of controls will reduce HCl emissions by 1,163 tpy. The installation of controls will reduce mercury emissions by 488 lbs per year (0.24 tpy). The installation of controls will reduce THC emissions by 570 tpy. Finally, the installation of controls will reduce D/F emissions by 9.5 × 10
Indirect or secondary air emissions impacts are impacts that would result from the increased electricity usage associated with the operation of control devices (
This action proposes emission limits for new and existing sources in the lime manufacturing source category. Although the action contains requirements for new sources, we are not aware of any new sources being constructed now or planned in the next year, and, consequently, we did not estimate any cost impacts for new sources. We estimate the total annualized cost of the proposed rule to existing sources in the lime manufacturing source category to be $32,000,000 per year. The annual costs are expected to be based on operation and maintenance of the added control systems. A memorandum titled “Proposed Maximum Achievable Control Technology (MACT) Floor Analysis for the Lime Manufacturing Plants Industry” includes details of tour cost assessment and is included in the docket for this action (Docket ID EPA-HQ-OAR-2017-0015).
For the proposed rule, the EPA estimated the cost of installing additional APCD in order to comply with the proposed emission limits. This includes the capital costs of the initial installation, and subsequent maintenance and operation of the controls. To assess the potential economic impacts, the expected annual cost was compared to the total sales revenue for the ultimate owners of affected facilities. For this rule, the expected annual cost is $920,000 (on average) for each facility, with an estimated nationwide annual cost of $32,000,000 per year. The 35 affected facilities are owned by 12 parent companies, and the total costs associated with the proposed amendments are expected to be less than one percent of annual sales revenue per ultimate owner.
The EPA also prepared a small business screening assessment to determine if any of the identified affected entities are small entities, as defined by the U.S. Small Business Administration. This analysis is available in the Docket for this action (Docket ID No. EPA-HQ-OAR-2017-0015). Because the total costs associated with the proposed amendments are expected to be less than one percent of annual sales revenue per owner in the lime manufacturing source category, there are, therefore, no significant economic impacts from these proposed amendments on the three affected facilities that are owned by small entities.
Information on our cost impact estimates on the sources in the lime manufacturing source category is available in the docket for this proposed rule (Docket ID No. EPA-HQ-OAR-2017-0015).
Consistent with EPA's commitment to integrating environmental justice (EJ) in the Agency's actions, and following the directives set forth in multiple Executive Orders, the Agency has carefully considered the impacts of this action on communities with EJ concerns. Executive Order 12898 directs the EPA to identify the populations of concern who are most likely to experience unequal burdens from environmental harms; specifically, minority populations (
To examine the potential for any EJ issues that might be associated with lime manufacturing facilities, we performed a demographic analysis, which is an assessment of individual demographic groups of the populations living within 5 kilometers (km) and 50 km of the facilities. The EPA then compared the data from this analysis to the national average for each of the demographic groups.
The results of the demographic analysis (see Table 8) indicate that the population percentages for certain demographic groups within 5 km of the 35 facilities are greater than the corresponding nationwide percentages. The demographic percentage for populations residing within 5 km of facility operations is 18 percentage points greater than its corresponding nationwide percentage for the Hispanic and Latino population (37 percent within 5 km of the facilities compared to 19 percent nationwide), 16 percentage points greater than its corresponding nationwide percentage for the population living in linguistic isolation (21 percent within 5 km of the facilities compared to 5 percent nationwide), 14 percentage points greater than its corresponding nationwide percentage for the population living below the poverty level (27 percent within 5 km of the facilities compared to 13 percent nationwide), 10 percentage points greater than its corresponding nationwide percentage for the minority population (50 percent within 5 km of the facilities compared to 40 percent nationwide), and 5 percentage points greater than its corresponding nationwide percentage for the population 25 years old and older without a high school diploma (17 percent within 5 km of the facilities compared to 12 percent nationwide). The remaining demographic groups within 5 km of facility operations are less than, or within one percentage point of, the corresponding nationwide percentages.
In addition, the proximity results presented in Table 8 indicate that the population percentages for certain demographic groups within 50 km of the 35 facilities are greater than the corresponding nationwide percentages. The demographic percentage for populations residing within 50 km of the facility operations is 5 percentage points greater than its corresponding nationwide percentage for the African American population (17 percent within 50 km to the facilities compared to 12 percent nationwide), 3 percentage points greater than its corresponding nationwide percentage for the population living below the poverty level (16 percent within 50 km of the facilities compared to 13 percent nationwide), and 2 percentage points greater than its corresponding nationwide percentage for the population living in linguistic isolation (7 percent within 50 km of the facilities compared to 5 percent nationwide). The remaining demographic percentages within 50 km of the facilities are less than, or within one percentage point of, the corresponding nationwide percentages.
A summary of the proximity demographic assessment performed for the major source lime manufacturing facilities is included as Table 8. The methodology and the results of the demographic analysis are presented in a technical report,
The human health risk estimated for this source category for the July 24, 2020, RTR (85 FR 44960) was determined to be acceptable, and the standards were determined to provide an ample margin of safety to protect public health. Specifically, the maximum individual cancer risk was 1-in-1 million for actual emissions (2-in-1 million for allowable emissions) and the noncancer hazard indices for chronic exposure were well below 1 (0.04 for actual emissions, 0.05 for allowable emissions). The noncancer hazard quotient for acute exposure was 0.06, also below 1. The proposed changes to the NESHAP subpart AAAAA will reduce emissions by 1,730 tons of HAP per year, and therefore, further improve human health exposures for populations in these demographic groups. The proposed changes will have beneficial effects on air quality and public health for populations exposed to emissions from lime manufacturing facilities.
We solicit comments on this proposed action. In addition to general comments on this proposed action, we are also interested in additional data that may improve the analyses. We are specifically interested in receiving any information regarding developments in practices, processes, and control technologies that reduce HAP emissions.
The site-specific emissions data used in setting MACT standards for HCl, mercury, THC, and D/F, as emitted from the lime manufacturing source category, are provided in the docket (Docket ID EPA-HQ-OAR-2017-0015).
If you believe that the data are not representative or are inaccurate, please identify the data in question, provide your reason for concern, and provide any “improved” data that you have, if available. When you submit data, we request that you provide documentation of the basis for the revised values to support your suggested changes.
For information on how to submit comments, including the submittal of data corrections, refer to the instructions provided in the introduction of this preamble.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2072.10. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
We are proposing changes to the reporting and recordkeeping requirements for the Lime Manufacturing Plants NESHAP by incorporating the reporting and recordkeeping requirements associated with the new and existing source MACT standards for HCl, mercury, THC, and D/F.
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 rule. The EPA will respond to any ICR-related comments in the final rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small businesses, as defined by the U.S. Small Business Administration. The Agency has determined that 3 lime manufacturing parent companies out of 35 may experience an impact 0.5 percent to 0.9 percent of annual sales. Details of this analysis are presented in “Economic Impact and Small Business Screening Assessments for Proposed Amendments to the National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Facilities”, located in the docket for this action (Docket ID No. EPA-HQ-OAR-2017-0015).
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. The EPA does not know of any lime manufacturing facilities owned or operated by Indian tribal governments. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's proposes emission standards for four previously unregulated pollutants; therefore, the rule should result in health benefits to children by reducing the level of HAP emissions emitted from the lime manufacturing process.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. In this proposed action, the EPA is setting emission standards for previously unregulated pollutant. This does not impact energy supply, distribution, or use.
This action involves technical standards. Therefore, the EPA conducted searches for the Lime Manufacturing NESHAP through the Enhanced National Standards Systems Network (NSSN) Database managed by the American National Standards Institute (ANSI). We also conducted a review of voluntary consensus standards (VCS) organizations and accessed and searched their databases. We conducted searches for EPA Methods 23, 25A, 29, 30B, 320, and 321. During the EPA's VCS search, if the title or abstract (if provided) of the VCS described technical sampling and analytical procedures that are similar to the EPA's referenced method, the EPA ordered a copy of the standard and reviewed it as a potential equivalent method. We reviewed all potential standards to determine the practicality of the VCS for this rule. This review requires significant method validation data that meet the requirements of EPA Method 301 for accepting alternative methods or scientific, engineering, and policy equivalence to procedures in the EPA referenced methods. The EPA may reconsider determinations of impracticality when additional information is available for any particular VCS.
Two VCS were identified as acceptable alternatives to the EPA test methods for this proposed rule. The VCS ASTM D6784-16, “Standard Test Method for Elemental, Oxidized, Particle-Bound and Total Mercury Gas Generated from Coal-Fired Stationary Sources (Ontario Hydro Method)” is an acceptable alternative to EPA Method 29 (portion for mercury only) as a method for measuring mercury. The VCS ASTM D6348-12e1, “Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy” is an acceptable alternative to EPA Method 320 with certain conditions. Detailed information on the VCS search and determination can be found in the memorandum, “Voluntary Consensus Standard Results for National Emission Standards for Hazardous Air Pollutants: Lime Manufacturing Technology Review,” which is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2017-0015). The two VCS may be obtained from
The EPA is incorporating by reference the VCS ASTM D6348-12e1, “Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy,” as an acceptable alternative to EPA Method 320. ASTM D6348-03(2010) was determined to be equivalent to EPA Method 320 with caveats. ASTM D6348-12e1 is a revised version of ASTM D6348-03(2010) and includes a new section on accepting the results from the direct measurement of a certified spike gas cylinder, but lacks the caveats placed on the ASTM D6348-03(2010) version. ASTM D6348-12e1 is an extractive FTIR field test method used to quantify gas phase concentrations of multiple analytes from stationary source effluent and is an acceptable alternative to EPA Method 320 at this time with caveats requiring
• The test plan preparation and implementation in the Annexes to ASTM D6348-03, Sections A1 through A8 are mandatory; and
• In ASTM D6348-03, Annex A5 (Analyte Spiking Technique), the percent (%) R must be determined for each target analyte (Equation A5.5).
In order for the test data to be acceptable for a compound, percent R must be 70 percent ≥ R ≤ 130 percent. If the percent R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the test must be repeated for that analyte (
The EPA is incorporating by reference the VCS ASTM D6784-16), “Standard Test Method for Elemental, Oxidized, Particle-Bound and Total Mercury in Flue Gas Generated from Coal-Fired Stationary Sources (Ontario Hydro Method),” as an acceptable alternative to EPA Method 29 (portion for mercury only) as a method for measuring elemental, oxidized, particle-bound, and total mercury concentrations ranging from approximately 0.5 to 100 micrograms per normal cubic meter. This test method describes equipment and procedures for obtaining samples from effluent ducts and stacks, equipment and procedures for laboratory analysis, and procedures for calculating results. VCS ASTM D6784-16 allows for additional flexibility in the sampling and analytical procedures for the earlier version of the same standard VCS ASTM D6784-02 (Reapproved 2008).
Additionally, EPA is incorporating by reference “Recommended Toxicity Equivalence Factors (TEFs) for Human Health Risk Assessments of 2, 3, 7, 8-Tetrachlorodibenzo-p-dioxin and Dioxin-Like Compounds” (EPA/100/R-10/005 December 2010), which is the source of the toxicity equivalent factors for dioxins and furans used in calculating the toxic equivalence quotient of the proposed dioxin and furan standard.
Executive Order 12898 (59 FR 7629, February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or Indigenous peoples) and low-income populations.
The EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on people of color, low-income populations and/or Indigenous peoples. The assessment of populations in close proximity of lime manufacturing facilities shows the percentage of Hispanic or Latino, below poverty level, and linguistically isolated groups are higher than the national average (see section V.E. of the preamble). The higher percentages are driven by 4 of the 35 facilities in the source category.
The EPA believes that this action is likely to reduce existing disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. The EPA is proposing MACT standards for HCl, mercury, THC as a surrogate for organic HAP, and D/F. EPA expects that the four facilities would have to implement control measures to reduce emissions to comply with the MACT standards and that HAP exposures for the people of color and low-income individuals living near these four facilities would decrease.
The EPA will additionally identify and address environmental justice concerns by conducting outreach after signature of this proposed rule. The EPA will reach out to tribes through a monthly policy call and with consultation letters. Additionally, the EPA will address this rule during the monthly Environmental Justice call for communities burdened by disproportionate environmental impacts.
The information supporting this Executive Order review is contained in section V.E of this preamble.
Environmental protection, Air pollution control, Hazardous substances, Incorporation by reference, Reporting and recordkeeping requirements.
Office for Civil Rights, Office of the Secretary, HHS.
Notice of proposed rulemaking (NPRM).
The Department proposes to partially rescind the May 21, 2019, final rule entitled, “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority” (“2019 Final Rule”), while leaving in effect the framework created by the February 23, 2011, final rule, entitled, “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws.” (“2011 Final Rule”). The Department also proposes to retain, with some modifications, certain provisions of the 2019 Final Rule regarding federal conscience protections but eliminate others because they are redundant or confusing, because they undermine the balance Congress struck between safeguarding conscience rights and protecting access to health care access, or because significant questions have been raised as to their legal authorization. Further, the Department seeks to determine what additional regulations, if any, are necessary to implement certain conscience protection laws. The Department is seeking public comment on the proposal to retain certain provisions of the 2019 Final Rule, including on any alternative approaches for ensuring compliance with the conscience protection laws.
Written comments must be received on or before March 6, 2023.
You may submit comments, identified by the Regulatory Information Number (RIN) [RIN 0945-AA18] by any of the following methods. The first is the preferred method. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions.
1.
2.
3.
Because of staffing and resource limitations, and to ensure that no comments are misplaced, the agency cannot accept comments by facsimile (FAX) transmission. All comments received on a timely basis will be posted without change to
Pamela Barron at (800) 368-1019 or (800) 537-7697 (TDD).
The Department of Health and Human Services (HHS) urges all interested parties to examine this regulatory proposal carefully and to share your views with us, including any data to support your positions. If you have questions before submitting comments, please see
If you are a person with a disability and/or a user of assistive technology who has difficulty accessing this document, please contact the Office for Civil Rights using the name and contact information provided in
Several provisions of Federal law prohibit recipients of certain Federal funds from coercing individuals and entities in the health care field into participating in actions they find religiously or morally objectionable. They include the following provisions.
The conscience provisions contained in 42 U.S.C. 300a-7 (collectively known as the “Church Amendments”) were enacted at various times during the 1970s in response to debates over whether receipt of Federal funds required the recipients of such funds to perform abortions or sterilizations. The first conscience provision in the Church Amendments, 42 U.S.C. 300a-7(b), provides that “[t]he receipt of any grant, contract, loan, or loan guarantee under [certain statutes implemented by the Department of Health and Human Services] by any individual or entity does not authorize any court or any public official or other public authority to require” (1) the individual to perform or assist in a sterilization procedure or an abortion, if it would be contrary to their religious beliefs or moral convictions; (2) the entity to make its facilities available for sterilization procedures or abortions, if the performance of sterilization procedures or abortions in the facilities is prohibited by the entity on the basis of religious beliefs or moral convictions; or (3) the entity to provide personnel for the performance or assistance in the performance of sterilization procedures or abortions, if it would be contrary to the religious beliefs or moral convictions of such personnel.
The second conscience provision in the Church Amendments, 42 U.S.C. 300a-7(c)(1), prohibits any entity that receives a grant, contract, loan, or loan guarantee under certain Department-implemented statutes from discriminating against any physician or other health care personnel in employment, promotion, termination of employment, or the extension of staff or other privileges because the individual “performed or assisted in the performance of a lawful sterilization procedure or abortion, because he refused to perform or assist in the performance of such a procedure or abortion on the grounds that his performance or assistance in the performance of the procedure or abortion would be contrary to his religious beliefs or moral convictions, or because of his religious beliefs or moral convictions respecting sterilization procedures or abortions.”
The third conscience provision, contained in 42 U.S.C. 300a-7(c)(2), prohibits any entity that receives a grant or contract for biomedical or behavioral research under any program administered by the Department from discriminating against any physician or other health care personnel in employment, promotion, termination of employment, or extension of staff or other privileges “because he performed or assisted in the performance of any lawful health service or research activity, because he refused to perform or assist in the performance of any such service or activity on the grounds that his performance or assistance in the performance of such service or activity would be contrary to his religious beliefs or moral convictions, or because of his religious beliefs or moral convictions respecting any such service or activity.”
The fourth conscience provision, 42 U.S.C. 300a-7(d), provides that “[n]o individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or in part under a program administered by [the Department] if his performance or assistance in the performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions.”
The final conscience provision contained in the Church Amendments, 42 U.S.C. 300a-7(e), prohibits any entity that receives a grant, contract, loan, loan guarantee, or interest subsidy under certain Departmentally implemented statutes from denying admission to, or otherwise discriminating against, “any applicant (including applicants for internships and residencies) for training or study because of the applicant's reluctance, or willingness, to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations contrary to or consistent with the applicant's religious beliefs or moral convictions.”
Enacted in 1996, section 245 of the Public Health Service Act (PHS Act) prohibits the Federal Government and
The Medicaid and Medicare statutes include certain conscience provisions as well. In particular, the Balanced Budget Act of 1997, Public Law 105-33, 111 Stat. 251 (1997), prohibits Medicaid managed care-managed organizations and Medicare Advantage plans from prohibiting or restricting a physician from informing a patient about his or her health and full range of treatment options.
These Medicare and Medicaid statutes also contain conscience provisions related to the performance of advanced directives.
The Weldon Amendment, originally adopted as section 508(d) of the Labor-HHS Division (Division F) of the 2005 Consolidated Appropriations Act, Public Law 108-447, 118 Stat. 2809, 3163 (Dec. 8, 2004), has been readopted (or incorporated by reference) in each subsequent legislative measure appropriating funds to HHS.
The Weldon Amendment provides that “[n]one of the funds made available in this Act [making appropriations for the Departments of Labor, Health and Human Services, and Education] may be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions.” It also defines “health care entity” to include “an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.”
In 2010, Congress passed the Patient Protection and Affordable Care Act (ACA), Public Law 111-148, 124 Stat. 119 (2010) (codified at 42 U.S.C. 18001,
Section 1553 provides that the federal government, any state or local government, and any health care provider that receives federal funding under the ACA, or any health plan created under the ACA, may not subject an individual or health care entity to discrimination on the ground that the individual or entity does not provide services for the purpose of causing or assisting in the death of any individual, including through assisted suicide, euthanasia, and mercy killing.
Section 1303 provides that a State may choose to prohibit abortion coverage in its qualified health plans, 42 U.S.C. 18023(a)(1), and that such a plan is not required to provide abortion coverage as part of its “essential health benefits,”
Section 1411 addresses exemptions to the ACA's “individual responsibility requirement.” 42 U.S.C. 18081(b)(5)(A). Under this section, the Department may grant exemptions based on hardship (which the Department has stated includes an individual's inability to secure affordable coverage that does not provide for abortions (84 FR 23172), membership in a particular religious
A number of additional provisions relating to conscience and religious liberty have also been the subject of previous HHS rulemaking. These include provisions related to compulsory health care services generally (42 U.S.C. 1396f and 5106i(a)), under hearing screening programs (42 U.S.C. 280g-1(d)), occupational illness testing (29 U.S.C. 699(a)(5)), vaccination programs (42 U.S.C. 1396s(c)(2)(B)(ii)), and mental health treatment (42 U.S.C. 290bb-36(f)). These also include conscience and nondiscrimination provisions tied to certain funding in global health programs and other funds administered by the Secretary.
No statutory provision requires the promulgation of rules to implement the conscience provisions outlined above. On August 26, 2008, however, the Department exercised its discretion and issued a proposed rule entitled “Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law” (73 FR 50274) to address the conscience provisions in effect at that time. In the preamble to the 2008 Final Rule, the Department concluded that regulations were necessary in order to:
1. Educate the public and health care providers on the obligations imposed, and protections afforded, by Federal law;
2. Work with state and local governments and other recipients of funds from the Department to ensure compliance with the nondiscrimination requirements embodied in the Federal health care provider conscience protection statutes;
3. When such compliance efforts prove unsuccessful, enforce these nondiscrimination laws through the various Department mechanisms, to ensure that Department funds do not support coercive or discriminatory practices, or policies in violation of Federal law; and
4. Otherwise take an active role in promoting open communication within the health care industry, and between providers and patients, fostering a more inclusive, tolerant environment in the health care industry than may currently exist.
“Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law,” 73 FR 78072, 78074.
The final rule went into effect on January 20, 2009, except that a certification requirement it imposed never took effect, as it was subject to the information collection approval process under the Paperwork Reduction Act, which was never completed.
On March 10, 2009, the Department proposed rescinding, in its entirety, the 2008 Final Rule, and sought public comment to determine whether or not to rescind the 2008 Final Rule in part or in its entirety (74 FR 10207). On February 23, 2011, after receiving more than 300,000 comments, the Department issued a final rule entitled “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws” (2011 Final Rule) (76 FR 9968). Concluding that parts of the 2008 Final Rule were unclear and potentially overbroad in scope, the 2011 Final Rule rescinded much of the 2008 Final Rule, including provisions defining certain terms used in one or more of the conscience provisions and requiring entities that received Department funds, both as recipients and subrecipients, to provide a written certificate of compliance with the 2008 Final Rule. The 2011 Final Rule retained a provision designating OCR to receive and coordinate the handling of complaints of violations of the three conscience provisions that were the subject of the 2008 Final Rule: the Church Amendments, the Weldon Amendment, and the Coats-Snowe Amendment.
On January 26, 2018, the Department issued a new proposed rule entitled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority” (83 FR 3880) (2018 Proposed Rule). Citing a desire to “enhance the awareness and enforcement of Federal health care conscience and associated nondiscrimination laws, to further conscience and religious freedom, and to protect the rights of individuals and entities to abstain from certain activities related to health care services without discrimination or retaliation,” the rule proposed reinstating several rescinded provisions of the Final 2008 Rule while also expanding upon that rule in a number of respects. Among other things, the 2018 proposed rule added a number of additional statutes and a detailed provision that would apply to alleged violations of any of the statutes covered by the rule.
In response to the 2018 Proposed Rule, the Department received more than 242,000 comments, from a wide variety of individuals and organizations, including private citizens, individual and institutional health care providers, religious organizations, patient advocacy groups, professional organizations, universities and research institutions, consumer organizations, and State and Federal agencies and representatives. Comments dealt with a range of issues surrounding the proposed rule, including the Department's authority to issue the rule, the need for the rule, what kinds of workers would be protected by the proposed rule, the rule's relationship to Title VII of the Civil Rights Act and other statutes and protections, what services are covered by the rule, whether the regulation might be used to discriminate against patients, how the rule would affect access to care, legal arguments, and the cost impacts and public health consequences of the rule.
On May 21, 2019, the Department issued a final rule (84 FR 23170) (2019 Final Rule). The Department concluded that the withdrawal of the 2008 Final Rule had created confusion about the various conscience provisions, citing what the Department determined was a significant increase in complaints alleging violations of a conscience provision that it had received since November 2016. The Department consequently reinstated the 2008 rule while revising and expanding on its provisions, including by (1) adding additional statutory provisions to the rule's enforcement scheme; (2) adopting definitions of various statutory terms; (3) imposing assurance and certification requirements; (4) reaffirming OCR's enforcement authority; (5) imposing record-keeping and cooperation requirements; (6) establishing enforcement provisions and penalties; and (7) adopting a voluntary notice provision.
Following the issuance of the 2019 Final Rule, a number of States, localities, and non-governmental parties filed suit challenging the rule in the Southern District of New York, the Northern District of California, the Eastern District of Washington, and the District of Maryland. Before the rule took effect, the New York, California, and Washington district courts granted summary judgment to the respective plaintiffs and vacated the rule in its entirety and on a nationwide basis.
Because the 2019 Final Rule never took effect, HHS has been operating under the 2011 Final Rule continuously since it was finalized. It currently accepts, investigates, and processes complaints under the framework created by the 2011 Final Rule. There are no significant reliance interests stemming from the 2019 Final Rule because the rule was vacated before it became effective. Because the 2019 Final Rule never went into effect, no person or entity could have reasonably relied on its provisions. It is possible that health care providers or individuals have reasonably relied on the 2011 Final Rule because it has remained operational.
As part of this proposed rulemaking, HHS seeks comments on the approach contemplated by the 2019 Final Rule as well as comments on the general framework that OCR has been employing since 2011—applying the plain text of the underlying statutes to the facts at issue on a case-by-case basis.
The Department is proposing to partially rescind the final rule entitled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority,” published in the
Though the Department received comments supporting and opposing the 2018 Proposed Rule (the basis for the 2019 Final Rule), the overwhelming majority of comments were in opposition to the rule.
Groups supporting the 2018 Proposed Rule said it would provide needed clarity and strengthen protections for conscience rights in health care. For example, a comment jointly filed by the U.S. Conference of Catholic Bishops, the National Association of Evangelicals, the Southern Baptist Ethics & Religious Liberty Commission, the Christian Legal Society, the Catholic Medical Association, and the Family Research Council commended the Department on the breadth of the proposed regulations, saying they would “provide much needed guidance as to the meaning of the conscience statutes.”
Other commenters opposed to the 2018 Proposed Rule raised a number of concerns, including that the rule would create confusion, place unnecessary burdens on covered entities, limit access to patient care, and result in individuals being denied access to services, with vulnerable populations being particularly affected. The American Medical Association, for example, commented that the proposed rule would undermine patients' access to care and information, impede research, and create confusion among providers about their legal and ethical obligations to treat patients.
Comments received on the 2018 Proposed Rule made valuable points about the importance of federal conscience protections as well as the importance of access to care free from discrimination. For this and other reasons, the Department is proposing to retain certain provisions from the 2019 Final Rule with modifications while rescinding others, and generally reinstating 2011 framework that has been in effect for some time.
The Department proposes to retain three aspects of the 2019 Final Rule: (1) the application to statutes first referenced in the 2019 Final Rule; (2) several enforcement provisions; and (3) a voluntary notice provision. The provisions proposed to be retained have been modified to address concerns raised by many of the commenters—and echoed in federal district court decisions—about the Department's underlying rulemaking authority.
First, the Department proposes to expand the category of “federal health care provider conscience protection statutes” covered by the rule to include the statutes that HHS added to § 88.3 in the 2019 Final Rule. Those statutes, which are described above, include conscience protections embedded in a wide range of Department programs, including Medicare and Medicaid, the administration of the Affordable Care Act, global health programs, health screenings, and more. Retaining these provisions as part of the rule, and maintaining OCR as the centralized HHS office tasked with receiving and investigating complaints under these provisions, will aid the public by increasing awareness of the rights protected by the various statutes and where to file complaints alleging violations of those rights.
Second, the Department proposes to retain a number of provisions from the 2019 Final Rule related to complaint handling and investigations. In the proposed § 88.2, the Department expands upon the 2011 Final Rule's description of complaint handling and investigation. Paragraph (a) describes OCR's authority to receive and handle complaints, seek voluntary compliance, and work with relevant Department components to ensure compliance through existing enforcement mechanisms. Paragraph (b) describes how OCR will conduct investigations. Paragraph (c) describes how OCR will proceed if an investigation reveals a violation of a federal health care provider conscience protection statute, and paragraph (d) provides that OCR will seek voluntary resolution of violations and will inform relevant parties if it has found no violation.
Finally, the Department proposes to retain the 2019 Final Rule's voluntary notice provisions, with some modifications to address concerns identified above. Notice of conscience protections and nondiscrimination laws under those provisions is an important means of promoting compliance. Such notices inform the public, patients, and workforce, which may include students or applicants for employment or training, of protections under the Federal conscience and nondiscrimination laws and this rule.
This proposed notice would advise persons and covered entities about their rights and the Department's and/or recipients' obligations under Federal conscience and nondiscrimination laws. The notice may also provide information about how to file a complaint with OCR if an individual believes that these laws have been violated, and may provide additional information to the patient on how to seek care.
Proposed paragraph (b) sets forth locations where the notice should appear: on the Department's and recipient's website(s), and in a physical location of each Department and recipient establishment where notices to the public and notices to their workforce are customarily posted. Proposed paragraph (c) would encourage covered entities to utilize the model notice and, if the recipient does not have a conscience-based objection to doing so, to provide information about alternative providers that may offer patients services the recipient does not provide for reasons of conscience. The Department proposes that recipients should be permitted to tailor their notice to their particular circumstances and communities, and paragraph (d) of § 88.3 proposes to permit recipients to combine the text of the notice specified in paragraph (a) with other notices.
The 2019 Final Rule, at § 88.5(A), provided that the OCR director would consider whether a covered entity posted OCR's model notice as non-dispositive evidence of compliance with the underlying federal conscience protection statute where relevant. This proposed rule modifies that provision to avoid implying that covered entities can substantively comply with the underlying statute by simply posting a notice. The Department believes such an implication could undermine the conscience and nondiscrimination protections provided by the underlying statutes themselves, and therefore the goal of this rule. While the Department considers posting a notice to be a best practice and encourages covered entities to post the model notice included in the proposed rule, we wish to avoid the implication that a covered entity can satisfy the substantive obligations imposed upon it by the underlying statutes by taking an action that none of the underlying statues designates as a method of demonstrating compliance with their substantive provisions.with. Covered entities must comply with the requirements of each of the federal health care provider conscience protection statutes identified in § 88.1 of the proposed rule, regardless of whether the notice is posted. We solicit comments on these voluntary notice provisions and specifically seek comment on whether posting a notice should be mandatory as contemplated by the 2018 Proposed Rule.
We encourage any relevant comments, including those that will assist the Department in assessing alternatives and reevaluating the necessity for additional regulations implementing the statutory requirements.
The Department proposes to rescind the other portions of the 2019 Final Rule because those portions are redundant, unlawful, confusing or undermine the balance Congress struck between safeguarding conscience rights and protecting access to health care, or because significant questions have been raised as to their legal authorization. This includes the purpose provision at § 88.1, the definitions that appeared at § 88.2, the applicable requirements and prohibitions that appeared at § 88.3, the assurance and certification requirements at § 88.4, compliance requirements at § 88.6, the relationship to other laws provision at § 88.8, and the rule of construction and severability provisions at § 88.9 and § 88.10. Those portions of the 2019 Rule were either: (1) redundant and unnecessary, because they simply repeated the language of the underlying statute; (2) have been deemed unlawful in district court decisions that raise
The proposed partial rescission n is informed by the three district court decisions that vacated the 2019 Final Rule prior to it taking effect and identified a number of serious questions that warrant additional careful consideration. Among other things, the litigation has raised significant questions regarding the complaints of statutory violations that served as a predicate for the 2019 Final Rule.
The Federal health conscience protection and nondiscrimination statutes represent Congress' attempt to strike a careful balance. Some doctors, nurses, and hospitals, for example, object for religious or moral reasons to providing or referring for abortions or assisted suicide, among other procedures. Respecting such objections honors liberty and human dignity. It also redounds to the benefit of the medical profession.
Patients also have autonomy, rights, and moral and religious convictions. And they have health needs, sometime urgent ones. Our health care systems must effectively deliver services—including safe legal abortions—to all who need them in order to protect patients' health and dignity.
Congress sought to balance these considerations through a variety of statutes. The Department will respect that balance. The Department remains committed to educating patients, providers, and other covered entities about their rights and obligations under the conscience statutes and remains committed to ensuring compliance. In light of the decisions discussed above, issues raised by commenters, and concerns about how the 2019 Final Rule approached the balance struck by Congress in the underlying statutes, the Department proposes to partially rescind the 2019 Final Rule, while maintaining some of its provisions, but otherwise preserve the status quo from 2011, which continues to be in effect. We solicit public comment to aid our consideration of the many complex questions surrounding the issue and the need for regulation in this area.
The Secretary proposes to partially rescind the May 21, 2019, Final Rule entitled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority.” As discussed above, the Church Amendments, section 245 of the PHS Act, the Weldon Amendment, and the Affordable Care Act require, among other things, that the Department and recipients of Department funds (including State and local governments) refrain from discriminating against institutional and individual health care entities for their participation in, abstention from, or objection to certain medical procedures or services, including certain health services, or research activities funded in whole or in part by the federal government. No statutory provision, however, requires promulgation of regulations for their interpretation or implementation. This proposed rule is being issued pursuant to the authority of 5 U.S.C. 301, which empowers the head of an Executive department to prescribe regulations “for the government of his department, the conduct of his employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.”
The Department seeks comments in order to determine whether or not to rescind the 2019 Final Rule in part or in its entirety or to modify that rule or parts of it, as well as to determine whether or not to leave in place the framework created by 2011 Final Rule, with additional authorities added to that framework, or otherwise to modify it. In particular, the Department seeks the following:
1. Information, including specific examples where feasible, addressing the scope and nature of the problems giving rise to the need for rulemaking, and whether those problems could be addressed by different regulations than those adopted in 2019 or by sub-regulatory guidance;
2. Information, including specific examples where feasible, supporting or refuting allegations that the 2019 Final Rule hindered, or would hinder, access to information and health care services, particularly sexual and reproductive health care and other preventive services;
3. Information, including specific examples where feasible, regarding complaints of discrimination on the basis that an individual or health care entity did not provide services for the purpose of causing or assisting in the death of any individual, including through assisted suicide, euthanasia, and mercy killing, as described in section 1553 of the ACA, and comments on whether additional regulations under this authority are necessary;
4. Information, including specific examples where feasible, regarding complaints of discrimination by a qualified health plan under the ACA on the basis that a health care provider or facility refused to provide, pay for, cover, or refer for abortions, as described in section 1303 of the ACA and comments on whether additional regulations under this authority are necessary;
5. Information, including specific examples where feasible, from health care providers regarding alleged violations of the conscience provisions provided for in the Medicaid and Medicare statutes, including the provisions codified at 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395w-22(j)(3), 1395x(e), 1395x(y)(1), 1395cc(f), 1396a(a), 1396a(w)(3), 1396u-2(b)(3), 1397j-1(b), and 14406(2) and comments on whether additional regulations under these authorities are necessary;
6. Information, including specific examples where feasible, regarding alleged violations of any of the other authorities that appeared in the 2019 Final Rule but not the 2011 Final Rule;
7. Comment on whether the 2019 Final Rule provided sufficient clarity to minimize the potential for harm resulting from any ambiguity and confusion that may exist because of the rule, and whether any statutory terms require additional clarification;
8. Comment on whether the provisions added by the 2019 Final Rule are necessary, collectively or with respect to individual provisions, to serve the statutes' or the rule's objectives, including with regard to whether the Department accurately evaluated the need for additional regulation in the 2019 Final Rule, and whether those provisions should be modified, or whether the rule's objectives may also be accomplished through alternative means, such as outreach and education;
9. Comment on the proposal to retain a voluntary notice provision, including comments on whether such notice should be mandatory, and what a model notice should include; and
10. Comment on the proposal to retain portions of the 2019 Final Rule's enforcement provisions in the proposed § 88.2.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is an economically significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would result in either a small reduction in costs to small entities or no impact on costs to small entities, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. This finding is consistent with the regulatory flexibility analysis of the final rule that would be partially rescinded by this regulatory action, which “concluded that this rule does not have a significant economic impact on a substantial number of small entities” (84 FR 23255).
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not create an unfunded mandate under the Unfunded Mandates Reform Act because it does not impose any new requirements resulting in unfunded expenditures by state, local, and tribal governments, or by the private sector.
HHS considered several policy alternatives, in addition to the approach of the proposed rule. This economic analysis considers the likely impacts associated with the following three policy options: (1) rescinding the 2019 Final Rule without exceptions; (2) adopting the approach of the proposed rule, which partially rescinds the 2019 Final Rule, and modifies other provisions; and (3) adopting the approach of the proposed rule, except further modifying the notice provision to require mandatory notices instead of voluntary notices. To simplify the narrative of this RIA, we present the impacts of rescinding the 2019 Final Rule in its entirety first, and then present the impacts of a partial rescission with modifications. These modifications correspond to the policy option of the proposed rule, and the policy option of mandatory notices. This RIA then summarizes the impacts of each policy option against common assumptions about the baseline scenario of no further regulatory action.
Rescinding the final rule entitled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority,” published in the
Under our primary baseline scenario, Policy Option 1 would entirely reverse the impacts of the 2019 Final Rule. To analyze the impacts of Policy Option 1 under this scenario, we provisionally adopt the estimates of the likely impacts of the 2019 Final Rule in its RIA, although we understand that commenters raised questions whether, for example, certain of the non-quantified benefits that the 2019 Final Rule anticipated would in fact be realized. The RIA identified five categories of quantified costs: (1) familiarization; (2) assurance and certification; (3) voluntary actions to provide notices of rights; (4) voluntary remedial efforts; and (5) OCR enforcement and associated costs. The narrative of the RIA described an approach for estimating each of these costs, and Table 6 of the RIA summarized the timing and magnitude of these quantified costs (84 FR 23240). In addition to identifying quantified costs, the RIA identified non-quantified costs associated with compliance procedures and non-quantified costs associated with seeking alternative providers of certain objected to medical services or procedures. The RIA did not identify any quantified benefits, but identified non-quantified benefits associated with compliance with the law; protection of conscience rights, the free exercise of religion and moral convictions; more diverse and inclusive providers and health care professionals; improved provider-patient relationships that facilitate improved quality of care; equity, fairness, nondiscrimination; increased access to care. We request public comment on whether the non-quantified benefits and costs identified in the 2019 Final Rule's RIA would likely be realized, absent any further regulatory action.
Table 1 of the 2019 Final Rule's RIA reported the present value and annualized value of the quantified costs and summarized the non-quantified costs and benefits of the 2019 Final Rule (84 FR 23227). That RIA reported estimates of the present value of the total costs over a 5-year time horizon of $900.7 million using a 3-percent discount rate and $731.5 million using a 7-percent discount rate. That RIA also reported annualized estimates of the costs of $214.9 million under a 3-percent discount rate and $218.5 million using a 7-percent discount rate. Both sets of these cost estimates were
Under our alternative baseline scenario, we assume that the 2019 Final Rule would never take effect, even without any additional regulatory action. Under this baseline scenario, Policy Option 1 would maintain the current status quo, which is characterized by the 2011 Final Rule (76 FR 9968). Thus, for this baseline scenario, we conclude that Policy Option 1 would result in only
The proposed rule would partially rescind the 2019 Final Rule, with certain exceptions. Specifically, the Department proposes to retain three aspects of the 2019 Final Rule: (1) the addition to part 88 of statutes including the 2019 Final Rule; (2) several enforcement provisions; and (3) a voluntary notice provision. However, as described in greater detail in the Preamble, the Department is also proposing to modify each of these provisions of the 2019 Final Rule. For example, the voluntary notice provision in the proposed rule would clarify that providing these voluntary notices would not satisfy an entity's substantive obligations imposed upon covered entities by the underlying statutes.
We considered the likely impacts of each of the three retained aspects of the 2019 Final Rule. We identify quantifiable impacts associated with retaining the aspects of the 2019 Final Rule related to the enforcement provisions and quantifiable impacts related to the voluntary notice provision. We adopt the analytic approach contained in the 2019 Final Rule's RIA to quantify these impacts, including an assumption in that RIA that about half of covered entities would provide notices voluntarily. For the provisions related to enforcement, the 2019 RIA estimated an annual impact of about $3 million in costs to the Department and $15 million in total costs over five years. For the provisions related to voluntary notices, that RIA estimated an impact of about $93.4 million in costs in the first year of the analysis, and about $14.1 million in costs in subsequent years, or about $150 million over five years. Combined, the 2019 RIA estimated 5-year costs for these two provisions of $165 million; in present value terms, these estimates are $142 million using a 3-percent discount rate and $118 million using a 7-percent discount rate. The 2019 RIA reported these costs in 2016 dollars.
To quantify the net impact of the proposed rule, we subtract the costs associated with enforcement and voluntary notice provisions from our earlier estimates of the total cost savings of rescinding the 2019 Final Rule. As an intermediate step, we converted the 2016 dollar estimates to 2021 dollars using the Implicit Price Deflator for the Gross Domestic Product. Compared to our primary baseline, we estimate that the proposed rule, if finalized, would result in annualized cost savings in 2021 dollars of $202.5 million using a 3-percent discount rate and $205.2 million using a 7-percent discount rate. We report these estimates in Table A, which also reports comparable estimates corresponding to our alternative baseline scenario.
We analyzed a third policy option, which is similar to the proposed rule, but would further modify the notice provision by requiring covered entities to post these notices in designated places. The 2019 Final Rule's RIA assumes that about half of covered entities would provide these notices on a voluntary basis, and we carried this assumption through in this analysis, including in our analysis of the costs of the proposed rule. Under Policy Option 3, we anticipate that all covered entities would provide notices, and therefore estimate that costs of mandatory notices would be double that of our estimates of the costs of voluntary notices.
To quantify the net impact of Policy Option 3, we subtract the costs associated with enforcement and mandatory notice provisions from our earlier estimates of the total cost savings of rescinding the 2019 Final Rule. Compared to our primary baseline, we estimate that Policy Option 3 would result in annualized cost savings in 2021 dollars of $168.0 million using a 3-percent discount rate and $169.2 using a 7-percent discount rate. We report these estimates in Table A, which also reports comparable estimates corresponding to our alternative baseline scenario.
This analysis estimates the costs associated with the proposed rule and for two policy alternatives. For the proposed rule, we estimate the present value of the costs of −$834.2 million using a 3-percent discount rate and −$657.2 million using a 7-percent discount rate. Alternatively stated, we estimate that the proposed rule would generate cost savings of $834.2 million using a 3-percent discount rate and $657.2 million using a 7-percent discount rate. Table A reports cost estimates for the proposed rule and for the two policy alternatives. These estimates are reported in millions of 2021 dollars over a 5-year time horizon. Table A presents these cost estimates in present value terms and as annualized values for both a 3-percent and a 7-percent discount rate. Table A reports these estimates for our primary baseline scenario that the 2019 Final Rule would take effect, and for an alternative baseline scenario that the 2019 Final Rule would never take effect, even without any subsequent regulatory action. We do not identify any quantified benefits for the proposed rule or for the two policy alternatives.
The RIA of the 2019 Final Rule also identified certain non-quantifiable impacts. That RIA discussed potential impacts related to compliance with the law; impacts related to conscience rights; impacts related to the composition of providers and health care professionals; impacts related to provider-patient relations; impacts related to equity, fairness, and nondiscrimination; impacts related to access to care; and additional non-quantified cost savings associated with compliance procedures (recordkeeping and compliance reporting) and seeking of alternative providers of certain objected to medical services or procedures. We request public comment on whether the non-quantified impacts identified in the 2019 Final Rule's RIA would likely be realized, absent any further regulatory action; and request comment on the extent to which each of the Policy Options, including the proposed rule, would result in comparable impacts.
We also request comment on whether covered entities have incurred costs attributable to the 2019 Final Rule that would not be averted by the proposed rule, if it is finalized; and further request data that would allow us to refine our quantified cost-savings estimates. For example, we request information that would allow us to quantify costs that covered entities previously incurred and are not recoverable, such as the costs associated with familiarization of the 2019 Final Rule.
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5 U.S.C. 301.
The purpose of this part is to provide for the enforcement of the Church Amendments, 42 U.S.C. 300a-7; the Coats-Snowe Amendment, section 245 of the Public Health Service Act, 42 U.S.C. 238n; the Weldon Amendment, Consolidated Appropriations Act, 2022, Pub. L. 117-103, div. H, title V General Provisions, section 507(d)(1) (Mar.15, 2022); Sections 1303, 1411, and 1553 of the ACA, 42 U.S.C. 18023, 18081, and 18113; certain Medicare and Medicaid provisions, 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395w-22(j)(3)(A)-(B), 1395x(e), 1395x(y)(1), 1395cc(f), 1396a(a), 1396a(w)(3), 1396u-2(b)(3)(A)-(B), 1397j-1(b), and 14406; Consolidated Appropriations Act, 2022, Pub. L. 115-245, div. H, section 209, div. K, title VII, section 7018; 22 U.S.C. 7631(d); 22 U.S.C. 2151b(f); 42 U.S.C. 280g-1(d), 290bb-36(f), 1396f, 1396s(c)(2)(B)(ii); 5106i(a)); and 29 U.S.C. 669(a)(5), referred to collectively as the “federal health care provider conscience protection statutes.”
(a)
(1) Receive and handle complaints;
(2) Conduct investigations;
(3) Consult on compliance within the Department;
(4) Seek voluntary resolutions of complaints; and
(5) Consult and coordinate with the relevant Departmental funding component, and utilize existing regulations enforcement, such as those that apply to grants, contracts, or other programs and services..
(b)
(c)
(d)
(2) If an investigation indicates a failure to comply with the Federal health care provider conscience protection statutes, OCR will so inform the relevant parties and the matter will be resolved by informal means whenever possible.
(a)
(b)
(1) On the Department or recipient's website(s);
(2) In a prominent and conspicuous physical location in the Department's or covered entity's establishments where notices to the public and notices to its workforce are customarily posted to permit ready observation;
(3) In a personnel manual, handbook, orientation materials, trainings, or other substantially similar document likely to be reviewed by members of the covered entity's workforce;
(4) In employment applications to the Department or covered entity, or in applications for participation in a service, benefit, or other program, including for training or study; and
(5) In any student handbook, orientation materials, or other substantially similar document for students participating in a program of training or study, including for postgraduate interns, residents, and fellows.
(c)
(d)
(e)
Any provision of this part held to be invalid or unenforceable either by its terms or as applied to any entity or circumstance shall be construed so as to continue to give the maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event such provision shall be severable from this part, which shall remain in full force and effect to the maximum extent permitted by law. A severed provision shall not affect the remainder of this part or the application of the provision to other persons or entities not similarly situated or to other, dissimilar circumstances.
[Name of entity] complies with applicable Federal health care provider conscience protection statutes, including [list applicable conscience statutes]. If you believe that [Name of entity] has violated any of these provisions, you can file a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of proposed rulemaking.
FMCSA proposes the implementation of certain requirements under the Moving Ahead for Progress in the 21st Century Act (MAP-21). Previously, FMCSA implemented the MAP-21 requirement to increase the financial security amount for brokers from $25,000 to $75,000 for household brokers and from $10,000 to $75,000 for all other property brokers and, for the first time, established financial security requirements for freight forwarders. The agency proposes regulations in five separate areas: Assets readily available; immediate suspension of broker/freight forwarder operating authority; surety or trust responsibilities in cases of broker/freight forwarder financial failure or insolvency; enforcement authority; and entities eligible to provide trust funds for form BMC-85 trust fund filings.
Comments must be received on or before March 6, 2023.
You may submit comments identified by Docket Number FMCSA
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Mr. Jeffrey L. Secrist, Chief, Registration, Licensing, and Insurance Division, Office of Registration, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or by phone at (202) 385-2367;
FMCSA organizes this notice of proposed rulemaking (NPRM) as follows:
If you submit a comment, please include the docket number for this NPRM (FMCSA-2016-0102), indicate the specific section of this document to which your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period.
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the 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 the NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the NPRM. Submissions containing CBI should be sent to Mr. Brian Dahlin, Chief, Regulatory Analysis Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001. Any comments FMCSA receives not specifically designated as CBI will be placed in the public docket for this rulemaking.
To view any documents mentioned as being available in the docket, go to
DOT solicits comments from the public to better inform its regulatory process, in accordance with 5 U.S.C. 553(c). DOT posts these comments, without edit, including any personal information the commenter provides, to
Written comments and recommendations for the information collection discussed in this NPRM should be sent within 60 days of publication to
FMCSA proposes modifications to broker and freight forwarder financial responsibility requirements.
This NPRM proposes modification in five regulatory areas.
Brokers and freight forwarders, surety bond and trust fund providers, and the Federal Government would incur costs for compliance and implementation. The quantified costs of the proposed rule include notification costs related to a drawdown on a surety bond or trust fund, and immediate suspension proceedings, FMCSA costs to hire new personnel, and costs associated with the development and maintenance of the BMC-84/85 Filing and Management Information Technology (IT) System. As shown in Table 1, FMCSA estimates that the 10-year cost of the proposed rule would total $5.4 million on an undiscounted basis, $3.8 million discounted at 7 percent, and $4.6 million discounted at 3 percent (all in 2020 dollars). The annualized cost of the rule would be $545,505 discounted at 7 percent and $542,343 at 3 percent. Ninety-eight percent of the costs would be incurred by the Federal Government.
This proposed rule would result in benefits to motor carriers. FMCSA is aware that some brokers improperly choose to withhold payment to motor carriers for services rendered. Motor carriers can then submit claims to the financial responsibility provider in an attempt to receive payment. If the financial responsibility provider has received claims against an individual broker that exceed $75,000, the financial responsibility provider will often submit the claims to a court in an interpleader action
FMCSA is relying on available data from which to draw an estimated percentage of how many brokers fail to pay motor carriers. The Agency's best estimate is that approximately 1.3 percent of brokers (approximately 440 in 2022) would experience a drawdown on their surety bond or trust fund within a given year, with average claim amounts of approximately $1,700 per claim submitted. Of these brokers, 17 percent may receive total claims in excess of $75,000, potentially leading to interpleader proceedings. Because this data is limited in scope, FMCSA cannot quantify benefits resulting from this proposal. It is FMCSA's intent that the provisions in this rule, if finalized, would mitigate the need to initiate interpleader proceedings and alleviate the concern of broker non-payment of claims.
In 2012, Congress enacted MAP-21 (Pub. L. 112-141, 126 Stat. 405, 822), section 32918 which contained requirements for the financial security of brokers and freight forwarders in amendments to 49 U.S.C. 13906(b) and (c). Section 32918(b) of MAP-21 (note to 49 U.S.C. 13906) directed the Secretary to issue regulations to implement and enforce the requirements under subsections (b) and (c) of section 13906. Authority to carry out and enforce these provisions has been delegated to the Administrator of FMCSA. (49 CFR 1.87(a)(5))
A “broker” is a “person . . . that as a principal or agent sells, offers for sale, negotiates for, or holds itself out by solicitation, advertisement, or otherwise as selling, providing, or arranging for, transportation by motor carrier for compensation.” 49 U.S.C. 13102(2); see also 49 CFR 371.2(a)(FMCSA regulatory definition of “Broker”). A “freight forwarder” is defined as “a person holding itself out to the general public (other than as a pipeline, rail, motor, or water carrier) to provide transportation of property for compensation and in the ordinary course of its business” (1) performs certain services including assembly, break-bulk or distribution services, (2) “assumes responsibility for the transportation from the place of receipt to the place of destination” and (3) “uses for any part of the transportation a carrier” such as a motor carrier. 49 U.S.C. 13102(8); see also 49 CFR 387.401(a)(FMCSA regulatory definition of freight forwarder).
Pursuant to 49 U.S.C. 13906(b), (c), brokers and freight forwarders must maintain financial security for the circumstance in which the broker or freight forwarder does not pay a motor carrier for services it provides. Prior to MAP-21, FMCSA required brokers to maintain financial security in the amount of $10,000 ($25,000 for household goods brokers). In MAP-21, Congress increased the broker financial responsibility requirement to $75,000 and extended those requirements to freight forwarders for the first time. (codified at 49 U.S.C. (b)(3), (c)(4)).
FMCSA implemented those MAP-21 financial responsibility limit requirements in a 2013 Omnibus rulemaking, 78 FR 60226 (Oct. 1, 2013), codified at 49 CFR 387.307(a) (brokers) and 49 CFR 387.403T(c) and 387.405 (freight forwarders). As a condition to obtain registration, brokers and freight forwarders must provide evidence of either a surety bond by filing a form BMC-84 or a trust fund by filing a form BMC-85 with the Agency.
In May 2016, FMCSA gathered stakeholders for an informal roundtable discussion on broker/freight forwarder financial responsibility (81 FR 24935, 24936, Apr. 27, 2016). Representatives of brokers, freight forwarders, motor carriers, surety providers, and trust fund providers participated in the roundtable and provided public comments to the docket established for the meeting. A transcript of this meeting is available in the docket for this rulemaking.
On September 27, 2018, FMCSA published an advance notice of proposed rulemaking (83 FR 48779) (ANPRM). The ANPRM indicated that the Agency was considering changes or additions in eight separate areas: Group surety bonds/trust funds; assets readily available; immediate suspension of broker/freight forwarder operating authority; surety or trust responsibilities in cases of broker/freight forwarder financial failure or insolvency; enforcement authority; entities eligible to provide trust funds for form BMC-85 trust fund filings; Form BMC-84 and BMC-85 trust fund revisions; and household goods (HHG). The Agency sought comments and data in response to the ANPRM.
When considering the data FMCSA received from its ANPRM, the Agency sought input from two Federal regulatory agencies, and based upon their suggestions reached out to several non-Federal entities as well. FMCSA appreciates the information shared by these entities, some of which helped inform our responses to comments on the ANPRM below. FMCSA met with the following entities:
1. United States Department of the Treasury, Federal Insurance Office (Treasury) on September 24, 2020.
2. Federal Deposit Insurance Corporation (FDIC) on October 13, 2020. In addition to offering their own thoughts, FDIC representatives suggested that FMCSA contact the Conference of State Banking Supervisors (CSBS) regarding relevant State regulations, sureties, trusts, and the regulation of broker and freight forwarder trust fund providers.
3. CSBS. FMCSA met with CSBS staff on October 14, 2020. FMCSA asked CSBS about oversight of financial companies including “loan or finance companies,” as well as definitions.
4. Florida Office of Financial Regulation on February 4, 2021. FMCSA asked for input regarding State regulation of entities providing financial responsibility.
5. Texas Office of Consumer Credit Commissioner on February 11, 2021. FMCSA shared relevant regulatory text and forms, as well as information regarding BMC-85 trust fund filers based in Texas.
FMCSA received 33 comments responsive to the ANPRM: 18 from individuals, 2 from a motor carrier and an owner-operator, 6 from trade organizations, 1 from a factoring company, 6 from surety providers or trust fund providers. Of the surety providers, one provided both BMC-84 surety bonds and BMC-85 trust funds and three provided BMC-84 sureties only. Two commenters provided BMC-85 trust funds. Seven commenters, including the Transportation Intermediaries Association (TIA), American Trucking Associations (ATA), and the Owner-Operator Independent Driver's Association (OOIDA), voiced their general support for the agency's plan to implement rulemaking. Two commenters objected to any rulemaking.
In the ANPRM, FMCSA asked for comments and data on eight areas related to broker and freight forwarder financial responsibility. To organize responses, the agency provided a list of 17 issues and asked commenters to address their comments to these issues (83 FR at 48786).
FMCSA specifically sought comment on the definitions of
Only one commenter attempted to provide a definition of
A trade organization stated that while multiple bond principals may be covered under a single bond, there is no specific definition of what constitutes a group bond. It noted that a bond with multiple principals is far less common than one with a single principal. The commenter believed that such a bond program would require the formation of a group or association of principals that have agreed among themselves to accept liability for the total financial responsibility and bonded activities of the group. The surety could then underwrite the bond, prequalifying each principal.
Another trade organization opposed any attempt to define group surety bonds or group trust funds. It maintained that any attempt would waste FMCSA's resources and harm motor carriers and drivers. Two commenters agreed that group surety bonds or trust funds would create an administrative burden for FMCSA and present the possibility of increased risk. They recommended that FMCSA not allow group trust funds or group bonds.
A trust fund provider recommended the following guidelines for the group or association providing a surety instrument for its members and believed they would not encumber the agency. The recommended guidelines would include: (1) providing coverage using an internal letter of credit guaranteed by dedicated assets; (2) annually providing audited financial statements to confirm stated assets, accompanied by an opinion letter from the certified public accounting firm conducting the audit; (3) establishing financial responsibility in an internal letter of credit in an amount equal to the lesser of the total individual member's liability or the aggregate amount; and (4) having an aggregate of $3 million for the group bond (based on the model of the FMC group bond).
Regarding the freight broker industry, a surety provider believed there is no need for group surety bonds or group trust funds, “nor an appetite to offer it in the surety industry.” The commenter wrote that the group surety bond or trust fund proposal does not provide an adequate model for the agency to ensure the levels of financial security as described by the statute. If FMCSA does not have the resources or expertise to regulate claims, the commenter recommended it not consider adding another option to satisfy the financial guarantee requirement.
In the absence of any evidence that demand for broker/freight forwarder securities cannot be met if the agency does not accept group sureties or trust funds, one trade organization commented it would be difficult to justify the burden for FMCSA of monitoring the sufficiency of group instruments. This commenter believed carriers would be wary of the uncertainty if brokers and freight forwarders were permitted to meet their financial responsibility requirements through group securities, which would open the door to a lower aggregate amount of assets available to pay claims.
A surety provider commented that providing a definition for a
Another trade organization believed the approach used by the ocean transportation industry may not be transferable to highway transportation because the two industries are drastically different, and the oversight exerted by FMC and FMCSA is also vastly different. Another surety provider provided background on FMC's rules, and reported that nearly 90 percent of foreign firms, and nearly 97 percent of all non-vessel operating common carriers, do not choose to make use of a group alternative. Noting this minimal use of FMC's group instrument, this commenter believed that individual bonding is sufficient to meet the needs of the marketplace and any group bond or trust is not necessary. This commenter also noted that, while the FMC regulations provide for a maximum liability limit of $3 million for a group bond, each member listed is required by regulation to maintain an individual level of financial responsibility of $75,000 (if in the U.S.)
FMCSA agrees with the commenter who noted that there is no evidence that the demand for individual instruments is not being met and that it would be difficult to justify the burden on FMCSA to monitor group instruments. FMCSA also finds it highly compelling that the original proponent of the group model no longer supports its inclusion as an option. In addition, FMCSA agrees with commenters that if the agency were to propose this group option, FMCSA would need to increase oversight to combat fraud. Given that FMCSA is primarily responsible for safety regulation and does not have extensive expertise in or resources for financial regulation, the agency believes focusing on existing financial tools to be the best use of its resources.
Due to the complexity and lack of an existing regulatory definition, FMCSA declines to propose allowing group surety bonds or group trust funds to provide financial responsibility.
By following FMC's lead and allowing group financial security for surface transportation intermediaries, one trade organization believed FMCSA could “minimize the devastating effect of the anti-competitive $75,000 financial security imposed by Congress.”
A surety provider wrote that if FMCSA allows group surety bonds or trust funds, the surety industry will not offer them as an option, because the surety industry underwrites each freight broker on its own merits, not in groups. This commenter noted further that, because the FDIC provides insurance coverage of $250,000 per depositor per FDIC-insured bank, each trustee should establish a separate bank account for every trust filed, in order to minimize the risk of claims.
MAP-21 Section 32918 required that trust funds or other financial security be limited only to “assets readily available to pay claims without resort to personal guarantees or collection of pledged accounts receivable.” 49 U.S.C. 13906(b)(1)(C) and (c)(1)(D). The agency asked for suggestions from the trust fund industry and others about instruments the agency could accept that would meet the “assets readily available” standard without requiring significant FMCSA oversight or evaluation that would divert scarce safety oversight resources.
In the ANPRM, the agency wrote that it is committed to adopting a definition of
A number of commenters agreed that assets readily available should include only cash or letters of credit from FDIC-approved banks, with others indicating cash bonds should be allowable; some of these commenters noted that only cash or equally liquid assets would satisfy the statutory mandate. A surety provider noted that the May 2016 roundtable discussion on this subject provided a general consensus that cash and letters of credit drawn on FDIC-approved banks should be acceptable. A trade organization commented that FMCSA must require trusts to be funded with cash or an equally liquid equivalent asset, such as an irrevocable letter of credit drawn on a federally regulated bank or trust company. One trade organization believed the only sufficient trust fund or surety funding sources are cash and an unconditional FDIC insured letter of credit, with the funds placed in a segregated account to be used solely for carrier claims.
These commenters stated that finance bonds should not be allowed, and that BMC-85s exist only because FMCSA allows them; FMCSA therefore should regulate and provide oversight of them.
Some commenters were concerned that some BMC-85 trustees may be comingling the available financial securities of brokers with other brokers' securities and even with the trustee's general operating accounts. A commenter wrote that the use of “unknown, hybrid, and possibly unenforceable internal debt instruments in lieu of cash or FDIC insured letters of credit violates the fiduciary responsibilities of BMC-85 trustees and undermines the objective of ensuring that brokers can personally meet the statutory financial requirements.” Some commenters, including a trade organization, recommended FMCSA allow letters of credit in the interest of making broker licenses accessible to start-up businesses and preventing unreasonable obstacles to entry. An individual commented that it is crucial that FMCSA support “the BMC-85 insurance products currently available to brokers in lieu of forcing brokers to have $75,000 available in cash at all times to pay claims.” This commenter believed that larger third-party logistics and broker entities otherwise will force smaller companies out of business, which will enable those larger companies to drive up rates. A commenter questioned whether FMCSA can limit the interpretation of “assets readily available” beyond saying that they are not personal guarantees or a collection of pledged accounts receivable, as provided in MAP-21. However, this commenter proposed using its “internal letter of credit plan,” $75,000 in cash, and/or a combination of a letter of credit supplied by an FDIC-insured bank to the surety provider. If interpretations relating to financial responsibility proposed by BMC-84 suppliers are implemented, this commenter believed, several BMC-85 providers may be forced out of the marketplace and the choices available to freight brokers and forwarders could be severely limited.
Another commenter believed the definition of “assets readily available” should be expansive enough to include “all kinds of investments.” The commenter wrote that the term should include publicly traded securities that can be quickly bought and sold on a highly regulated open market exchange. The commenter noted that, in reality, claims are not paid before 30 days of the claim being filed.
A trade organization encouraged the agency to adopt a definition of assets readily available to include the assets set forth in Federal Acquisition Regulation 28.204-1-28.204-3, which applies to the type of securities that may be deposited by a contractor in lieu of a surety bond on public works. The types of assets are: (1) notes or bonds issued by the U.S. Government; (2) certified or cashier's check, bank draft, postal money order, or currency; or (3) an irrevocable letter of credit issued by a federally insured financial institution rated investment grade. The commenter maintained that a broader and riskier asset class would require more intensive monitoring and ongoing valuation by the agency to ensure that the BMC-85 trust fund remains capitalized over the $75,000 requirement.
BMC-84 bond providers are overseen by the Treasury, while BMC-85 trusts are overseen by FMCSA, in addition to other regulators. The agency solicited suggestions about how it could accept letters of credit and other instruments that could meet the assets readily available standard for broker/freight forwarder trust funds without requiring significant oversight or evaluation that would divert scarce agency safety resources. (83 FR 48783)
A trade organization wrote that the acceptance of any third-party collateral instrument, personal guarantees, or a pledge of business assets should not be considered eligible trust collateral unless the agency is satisfied with the financial structure of the issuer/obligor and that it possesses unimpeded access to assets in the event of payment demand. Because such information is not currently available to the FMCSA or to motor carriers, any attempt to define or administer such an option would be wasteful of FMCSA resources and harmful to the motor carriers and drivers.
A trade organization recommended the agency require the trust to conduct a regular, independent audit confirming that the trust is fully funded. It commented that a broader and riskier asset class might impair the value of the BMC-85 trust fund, trigger a suspension required under 49 U.S.C. 13906(b)(5) and (c)(6), and require more intensive monitoring and ongoing valuation by the agency. A surety provider wrote that FMCSA could verify annually that a letter of credit issued by an FDIC-insured bank is in force without hardship.
A surety provider suggested that the property broker or freight forwarder needs to deposit with the trust administrator cash or similar assets like Treasury debt instruments. It also believed that the trust could accept a qualified bank letter of credit (
A surety provider rejected the argument that FMCSA accept self-issued or internal letters of credit. It stated that FMCSA would have no assurance or control over the quality or quantity of the security behind the letter of credit. This plan would place an administrative burden on the agency and increase the potential for losses to the intended beneficiaries.
A surety provider wrote that, to ensure that assets are readily available, they must be defined, insured, and verified. While it had previously recommended defining assets readily available as cash and an irrevocable letter of credit (ILOC) from an FDIC-insured bank, in consideration of FMCSA's desire to limit its oversight responsibilities, this commenter changed its asset recommendation to cash only. The commenter believed that allowing any other asset would add to the administrative burden of FMCSA's oversight. Because assets must be properly insured, the commenter said it is imperative that the assets be held in an FDIC-insured bank to provide FDIC insurance coverage of $250,000 per account and ensure that FMCSA does not have to underwrite or question the solvency of the bank holding the assets. The commenter maintained that an ILOC is not insured by the FDIC (even if issued by an FDIC-insured bank) unless there is a deposit of cash in an FDIC-insured bank backing the ILOC. Should FMCSA allow ILOCs, the commenter said FMCSA would have to verify whether each bank backing the ILOC was FDIC-insured, and that the balance was under the $250,000 insurance threshold. Further, the commenter reasoned that, if cash were the only accepted form of assets readily available, the trustee could use one bank to manage all assets, creating a separate account of $75,000 for each trustor.
This same surety provider also recommended that FMCSA require trust providers to submit audited financial statements prepared by a licensed third-party certified public accountant on a quarterly basis, to lighten FMCSA's administrative burden of verifying assets. If the acceptable assets were limited to cash, the commenter believed that FMCSA could easily confirm enough cash is being held by reviewing the financial statement. However, should FMCSA wish to allow ILOCs, FMCSA would need to ensure that each BMC-85 has an ILOC from an FDIC-insured bank along with a bank account with deposits to fund the ILOC in full, making audits far more complex.
In the ANPRM, FMCSA specifically sought comment from the surety bond industry on that industry's capacity to meet market demand if FMCSA were to adopt a cash-only standard for BMC-85 trust funds. The agency asked whether such a policy could drive a significant segment of the broker/freight forwarder industry into surety bond coverage.
Commenters responded that they believed surety-bond providers could meet this demand.
FMCSA sought comments and data from the surety bond industry on the cost to brokers and freight forwarders of BMC-84 surety bonds. In response to this issue, one trust provider commented that the question should not be the cost to brokers of BMC-84 surety bonds, but what percentage of the market currently serviced by BMC-85 providers will be lost. This commenter noted that BMC-85 providers service roughly 25 percent of the total licensed freight brokers and freight forwarders in the country.
One trade organization and three surety providers provided a range of estimates of the cost of a bond. The trade organization reported that a BMC-84 bond will typically cost its principal 1 to 2 percent of the face value of the bond. A creditworthy broker or freight forwarder would expect to pay approximately $750 to $1,500 to obtain a $75,000 BMC-84 bond. The commenter did not expect that cost to increase, even with increased demand for the bonds. A surety provider wrote that pricing for this class of bond usually ranges from 2 to 5 percent of the amount of the bond, calculated and charged on an annual basis. The commenter noted that the pricing range is typically driven by the credit strength of the business and qualified indemnitors. Another surety provider commented that typical costs for license and permit bonds run from 1 to 4 percent of the face amount of the bond. A third surety provider reported that average surety premiums have dropped each year since 2013 with rates as low as $750 per year.
Some commenters noted other issues related to assets readily available. Several commenters were concerned with what they believed are irregularities in the BMC-85 trust fund industry. A trade organization commented that a major concern is that certain trust fund operators are not following the laws and regulations, to the detriment of safety. If small motor carriers are not paid, necessary maintenance and repairs may be put off or ignored due to reduced cash flow.
One trade organization recommended that, in order for a BMC-85 trust fund to be equivalent to a surety bond, the BMC-85 trust fund should have a prequalification function, where a surety reviews the capabilities and financial strength of a bond applicant. It believed an adequate version of prequalification can be achieved if the broker or freight forwarder is required to fund the BMC-85 trust with its own assets. In this way, the agency and carriers would have the assurance that the brokers and freight forwarders have the operational capability to commit $75,000 of their own assets into the fund.
A surety bond provider expressed the belief, based on the comments at the roundtable and the definition of a trustee, that most BMC-85 providers are not trustees but are providing unregulated surety bond insurance without a license to do so. This commenter indicated that FMCSA must regularly examine trust providers to ensure that the defined assets meet the aggregate liability of the trust provider.
A surety provider commented that, if trusts are to be funded with a limited category of assets, without requiring significant FMCSA oversight or evaluation, trust fund administrators should be allowed to invest the assets only in highly-liquid, short duration, and very safe investments, and it provided examples. The commenter recommended that all investments should be easily provable to the FMCSA,
Two commenters responded to the concern about the financial wherewithal of BMC-85 trust providers and the sufficiency of the assets in BMC-85 trusts to pay legitimate claims by motor carriers or shippers. A commenter noted FMCSA's statement in the ANPRM that representatives of the BMC-85 trust fund provider community asserted that, with one limited exception, no evidence had been provided showing that BMC-85 providers have failed to pay legitimate claims made on their trusts by motor carriers or shippers to any significant degree. The commenter also believed that no legitimate stakeholder who had suffered any financial losses had appeared. This commenter therefore did not believe that rulemaking in this regard is necessary.
A BMC-85 trust fund provider sought to refute the contention that such providers support financially unstable brokers to the detriment of motor carriers and the transportation industry in general. The commenter believes it has the largest claims database specific to this industry and said that its claims data do not support those assertions. The commenter stated that, on the contrary, many BMC-84 surety companies enter and leave the market every few years because their realized losses are much higher than initially anticipated. The commenter said many surety companies will not issue BMC-84s due to the inherent high-risk factors.
MAP-21 provides that FMCSA shall immediately suspend the registration of a broker or freight forwarder if their available financial security falls below $75,000 (49 U.S.C. 13906(b)(5), (c)(6)). In the ANPRM the agency discussed, and invited comment on, how it could immediately suspend broker/freight forwarder operating authority registration consistent with due process requirements,
In the ANPRM, FMCSA said that it first needed to determine when the available financial security of a broker/freight forwarder is below $75,000. The agency considered effecting immediate registration suspension in either or both of two situations. First, FMCSA would suspend when it receives notice from the surety or trust fund provider that a drawdown/payout on the bond/trust has occurred, such that the available financial security is less than $75,000. The second situation would be where: (a) a surety or trust fund provider gives reasonable notice of a claim to the broker/freight forwarder, (b) the broker/freight forwarder does not respond, and (c) the surety/trust fund provider determines that the claim is valid and provides notice of these events to FMCSA. . A trade organization supported the agency's proposed approach to triggering the agency's statutory obligation to immediately suspend registrations, saying it appeared to be a sensible proposal. A surety provider agreed that it must be “explicitly detailed as to when the security falls below $75,000.”
A trade organization wrote that it supported a recommendation of Avalon Risk Management that three or more valid claims from different sources, aggregating more than $25,000, that have remained unresolved for at least 30-days is one reasonable standard. It wrote that the agency needs to clarify what constitutes financial failure or insolvency so that the surety or trust provider will not be at risk if it invokes the procedures under 49 U.S.C. 13906(b)(6) and (c)(7) to terminate the security and start the 60-day period for submission of claims. The commenter noted that this sometimes occurs over the objections of the broker or freight forwarder.
A surety provider suggested that failure of the broker/forwarder to respond in any manner to the surety or trust fund provider in 5 business days should be sufficient to permit the surety/trust to request immediate suspension, publish the notice, and start the 60-day clock for presentation of claims.
The same commenter added that, if written evidence is provided that the validity of the claim is reasonably disputed, parties should be afforded more time. In addition, the commenter believed that failure to resolve a specified number of undisputed claims representing a specified percentage of the security after 30 days should be construed as an impairment of that security and a financial failure, triggering immediate suspension. The commenter believed that financial failure outside of bankruptcy should be a trigger for immediate suspension, but noted that “financial failure” is undefined, and the operating authority holder's actual situation is difficult to determine. While the commenter recognized that larger operators would have more claims, it asserted that best practices would keep them within these parameters.
A surety provider believed that the only scenario where the financial security amount would drop below $75,000 in the case of a surety would be if the surety were to issue some sort of refund or if the surety were to pay a claim, which would reduce the value of the trust below $75,000; thus, this section should be read in conjunction with 49 U.S.C. 13906(b)(2)(A), “Payment of Claims.” However, the commenter anticipated problems with any of the scenarios in which the surety provider pays a claim against a broker as a justification for immediate suspension. The commenter believed that a broker's failure to respond to emails and phone calls from the surety is a good indication that the brokerage is experiencing or has already experienced financial failure warranting immediate cancellation. Another situation that might trigger immediate cancellation would be if a broker responds but fails to provide information to resolve the claim within a reasonable period. The surety provider wrote that a brokerage experiencing financial failure typically uses delaying tactics to buy more time. The commenter recommended that the surety provider be able to request the immediate suspension of a brokerage, given the totality of the circumstances involved (
A trade organization provided a draft of a new § 387.307 containing a process that the commenter believed would lead to FMCSA's suspension of a broker's operating authority when required under the statute. The commenter recommended that, if by the end of 10 days following notice of the claim, the broker ignores the notice, does not dispute the motor carrier's claim, does not pay the claim, or does not provide the information and documents described in the draft section, the surety consider the motor carrier's claim valid and payable under the bond or trust. The surety would then have to notify FMCSA that the amount of available security is less than required by law, triggering the 30-day period for cancellation under 49 U.S.C. 13906(b)(4)(A). Under the commenter's proposal, the presumption of insolvency and cancellation notice would be lifted if the broker were to file a completely new bond or trust within 30 days. The commenter believed that, if a broker owes a motor carrier money and does not pay the motor carrier, or ignores the surety's notice of the claim, FMCSA could reasonably consider the broker to be financially insolvent under 49 U.S.C. 13906(b)(6). The only time a 30-day cancellation period should run while the broker continues to do business is when there have been no valid claims filed on its bond. The commenter believed such a rule would prevent brokers from continuing to incur debt to motor carriers that is not protected by a compliant surety bond or trust.
In the ANPRM, FMCSA sought comment on the appropriate allowable time period or “cushion time” for brokers or freight forwarders to respond to claims made to guarantors, valid or otherwise. Such a grace period would give firms adequate time to adjudicate claims and settlements internally, as well as to factor in costs associated with contract noncompliance when setting their pricing.
Several individuals who commented on this process believed the broker should have 30 days to pay the driver or company. One individual added that the bond company should have 30 days after that to pay the carrier. Another commenter believed the broker needs at least 60 days from the time the notice of a violation/claim is issued to respond and up to 90 days after acknowledgement of receipt to show corrective action. A third commenter said that carriers must be paid within a day. Three individuals wrote that brokers should have their licenses revoked immediately.
A trust provider, responding to FMCSA's suggested 14-day grace period for brokerage response to a notice or claim, said a surety company's determination of cancellation is routinely made much sooner. The commenter said 5 business days is all that is necessary to determine if a brokerage is still in operation, can be contacted, and can respond appropriately to the notice of claim. The commenter emphasized that any bright line rule would not work, and instead the agency's determination should be based on the totality of circumstances and the surety's prior experience and knowledge. A trade organization, however, believed a period of at least 2 weeks is appropriate. While that commenter appreciated the need to move swiftly, it also recognized that intermediaries need time to internally investigate claims and that suspending an intermediary's registration may result
A surety provider believed that, if after 3 to 5 days the principal has not made payment or explained its reason for non-payment, the surety can start to presume the principal may be experiencing financial failure or insolvency. The commenter wrote that a broker or freight forwarder should be able to determine, almost immediately, why it has not paid the carrier within the period to which both carrier and broker had contractually agreed. Because not every bond termination would be due to claims, it commented that FMCSA must allow for the surety or trust provider to be able to identify when a termination should involve immediate suspension of authority.
A surety provider believed that revocation of authority immediately or within 48 hours of cancellation of bond/trust would help prevent carriers from being left with little or nothing to show for their services. The commenter wrote that there are brokers who have entered the industry who post loads with no intent on paying the carrier. It explained that the surety or trust company will not receive a claim against these brokers for at least 30 days since, under the current regulations, brokers have an additional 30 days to broker loads before their authority is revoked by FMCSA (33 actual days). The commenter said this is one of the reasons why so many carriers receive only partial settlement of their original claim amount.
A surety provider commented that protection of motor carriers requires that a broker or freight forwarder who fails to pay should be immediately suspended or otherwise sanctioned to induce the payment. The commenter again suggested that the failure of the broker/forwarder to respond in any manner to the surety/trust within 5 business days should be sufficient to permit the surety/trust to request immediate suspension, publish the notice, and start the clock on the time to present claims. If written evidence is provided that the validity of the claim is reasonably disputed, the parties should be afforded time to resolve their issues, including reducing the claim to judgment if necessary. The commenter asserted, however, that in any case when a surety or trust provider submits a request for immediate termination, the termination should be effective within 2 business days from the request. A surety provider noted that it is difficult to establish a hard rule regarding a grace period, as each situation is unique.
Suspending broker or freight forwarder operating authority whenever a claim is filed against a broker or freight forwarder or its bond or trust would raise due process concerns, as the agency would be prohibiting the broker or freight forwarder from lawfully operating, without affording the company a chance to respond. In the ANPRM, the agency wrote it would consider how it could immediately suspend broker or freight operating authority registration in a manner consistent with constitutional due process requirements,
A surety provider commented that due process requires that the broker or forwarder be given an opportunity to address the claim and present any defenses that may exist.
A trade organization raised a Fourteenth Amendment “Equal Protection of the Law” claim and asserted that the government cannot lawfully suspend the authority of brokers and forwarders upon mere notice of cancellation and not apply the same procedure to situations in which motor carriers' insurance companies have filed similar notices of cancellation. The commenter wrote that the procedure currently in place was enacted to ensure due process and a reasonable time to respond.
A trade organization commented that a licensed property broker or freight forwarder should not have its authority suspended immediately based on claims received, because invalid claims are often made. Ensuring fair due process is an essential part of this rulemaking for the commenter and its members. Furthermore, suspending authority without due process would cause a flood of authority reinstatements and re-processing for all involved, increasing the burden on the agency.
Specifically in response to this issue, a surety provider described the existing process when a surety receives claims against a bond: (1) the surety contacts the bond principal to advise it of the claim, determine whether any defenses exist, and/or whether the claim will be promptly handled by the bond principal; (2) the surety may become aware that the business is failing and may determine the bond should be terminated; (3) when this happens, the surety gives notice of termination to FMCSA, which takes effect 30 days later. As the reporting window for claims begins, the surety may receive more claims from other parties for transportation before and after the date on which notice of the bond termination was given to FMCSA.
A trade organization proposed detailed regulatory language that it believed would set up a clear process that would lead to FMCSA's suspension of a broker's operating authority when required under the statute. This draft language proposed by the trade organization sets out the information a motor carrier would be required to submit to a surety or trustee to make a claim and establishes that the motor carrier may not be required to provide any other information. The commenter's proposed text requires that, if the motor carrier does not submit a claim that meets the requirements, the surety may immediately provide notice of the claim's deficiencies and give the motor carrier an opportunity to refile the claim. If the motor carrier provides a copy of a judgment in its favor against the broker, the surety will consider the motor carrier's claim against the bond valid. The commenter also proposed detailed procedures the surety would use to give brokers notice of a claim against the bond, provide the broker the opportunity to pay the motor carrier and provide proof to the surety. It also proposed a procedure for a broker's response to a claim—which the broker would have to provide within 10 business days of receiving notice of a claim against its surety bond from a surety or trustee. However, the commenter noted that it did not intend for this proposed process to be a substitute for the resolution of legitimate disputed claims between brokers and motor carriers. Instead, the proposal was intended to apply when brokers ignore a surety's notice of motor carrier claims or when brokers do not bother to dispute such claims with the minimal, timely response required under the rules. This distinction was intended to ensure that sureties and FMCSA do not have the duty to resolve legitimate disputes between a broker and a motor carrier. Sureties only need to identify that there is a legitimate dispute, as described above. The same commenter also encouraged FMCSA to adopt a process that would allow
A surety provider commented that, if it was forced to cancel a policy upon notice of a claim, freight brokers would be regularly shut down even for illegitimate claims. While forcing an immediate suspension of all freight brokers with claim activity would be better for its own bottom line, the commenter believed “it simply is not fair to freight brokers.” The commenter therefore recommended that surety bond and trust providers not be forced to cancel until a claim has been paid, which would be consistent with MAP-21 section 32918. Instead, cancellation prior to claims being paid out should be left to the discretion of the surety, and this approach is consistent with that taken by many other government agencies. The commenter added that the insurance carriers that back its bonds are highly motivated to ensure that they cancel bonds with legitimate claims as soon as possible, as each legitimate claim greatly impacts the profitability of the surety industry.
In the ANPRM, FMCSA asked for documented incidents of actual nonpayment that occurred after a financially troubled broker or freight forwarder was not immediately suspended. A trade organization commented that FMCSA must immediately suspend the registration of a broker before the broker's nonpayment to motor carriers results in claims on its bond or trust in an aggregate amount of more than $75,000. Further, it commented that FMCSA must reject the fiction that considers a bond to be in effect until a claim is actually paid on the bond, which means the broker can continue to conduct business even if there is effectively no longer any financial security in place. The commenter wrote that, under this practice sureties now wait to confirm that they have collected all the claims triggered by the broker before making any payout. By then, the pro-rata payouts from the bond to motor carrier claimants amount to cents on the dollar. The trade organization appended to its comment an excerpt of a list of motor carrier claims against broker bonds that it had helped the motor carriers lodge with sureties and trustees. The commenter believed this list shows that the failure of the bond or trust security to cover all of a broker's debts to its motor carriers is a common problem. The commenter also provided as an example a September 2018 court case in which a BMC-84 surety provider (Merchants Bonding Co.) filed an amended complaint in interpleader asking a U.S. District Court to determine how to pay the $75,000 bond to a total of 646 claimants.
A representative of a motor carrier reported that it had not been paid for a few loads by freight brokers and could collect only about 10 percent of what was due because there were too many claims. Because the freight brokers are permitted to work for 45 days after such unpaid claims are reported, they can increase the amount they owe; however, the motor carrier believed that those brokers never intended to pay anything.
A surety provider submitted an example of a brokerage that continued to book 27 loads with a total value of more than $35,000 after cancellation had been requested. This provider commented that terminating the bond immediately does not stop claims from accumulating, but it does help mitigate damages. Further, it wrote that moving loads so close to effective cancellation decreases the motor carriers' chances of filing a claim within 60 days of effective cancellation (as they are normally contacting the surety 60 to 90 days after delivery and therefore the 60-day window for accepting applications will have passed) and increases the chances that the payout will be pro rata. A second surety provider submitted the example of a logistics company that had accumulated $945,739 in unpaid motor carrier claims after paying out the full corpus of a $75,000 BMC-85 Trust.
A surety provider wrote that many bond principals, terminated recently due to claims, also had claims for shipments that began after the termination notice was given, but still within the time when the bond principal's FMCSA operating authority was valid. For moves that occurred after the termination notice was given, it reported that nearly all occurred within the first 14 calendar days. This commenter believed that when a bond termination is due to claims, an immediate suspension of FMCSA operating authority would prevent post-notice shipments from becoming the subject of further claims, and would prevent carriers on those shipments from encountering delays in getting paid under the bond or getting only partial payment. The commenter added that the pre-notice claims would benefit from a higher pro-rata payment.
A trade organization commented that an unintended consequence of a larger bond is that $75,000 actually gives truly fraudulent brokers more room to steal than the original $10,000 bond. While it believed the government should enforce the laws, it concluded that “[t]he principles of laissez-faire should apply here.”
Another trade organization believed that many carriers know there is little hope to recover from a bond and do not even bother filing their claims against the bond. Those who do file a claim must have the ability to file a complaint in interpleader or hire a lawyer.
A surety provider commented that the surety/trustee is being placed in the role of arbiter with further restrictions on how to execute the role. If a broker or forwarder disputes a claim, this commenter wrote, the surety or trustee has its hands tied and the claimant must be told it needs to obtain a judgment to pursue the claim. Questionable operators can continue to stack up liabilities by asserting that the claim is being taken care of but then fail to resolve the claim or provide any evidence of its invalidity. The
The ANPRM sought comments on the how
In the ANPRM, the agency suggested criteria for a definition of
None of the commenters on this issue believed that establishing an absolute definition of
A surety provider defined
In the event of financial failure or insolvency, surety providers must publicly advertise for claims for 60 days beginning on the date FMCSA publishes the surety's notice to cancel the surety bond/trust (49 U.S.C. 13906(b)(6)(B), (c)(7)(B)). In the ANPRM, FMCSA wrote that it is considering a definition of
Most of those who commented on this issue believed that the requirement to publicly advertise should be satisfied by the surety provider giving notice to FMCSA, which FMCSA would then make publicly available. However, one trade organization recommended that FMCSA publish a notice in the
A trade organization believed that if FMCSA provided public notice of cancellation under 49 U.S.C. 13906(b)(4)(B), motor carriers could look up a broker's registration status before taking a load from that broker. Such FMCSA notice would also provide the dates that the 60-day claims period commenced and the due date for claims to be filed with the surety on the bond. The commenter recommended that FMCSA change its Licensing and Insurance page to provide a link to the surety's web page indicating how many unresolved claims have been submitted against the bond, similar to FMCSA's publication of motor carrier inspection and accident data on the Motor Carrier Management Information System.
In addition to notice on the FMCSA website, several surety providers suggested posting on the surety provider's website or FMCSA providing a hyperlink to the provider's website. A surety provider believed that flagging the posting with a code identifying the reason for cancellation (claim activity vs. non-compliance) would benefit both motor carriers and other surety providers, as many of these “bad” brokerages jump from surety to surety, leaving claims behind. This commenter also believed that, as approved filers with login credentials, surety providers should be provided access to all information and documentation that has been filed with FMCSA (
A surety provider wrote that upon cancellation of a BMC-84 surety bond or a BMC-85 trust, the issuer of the bond or trust should be required to post the cancellation and advertise for claim submission on its website for no less than 60 days. The commenter asked FMCSA to allow 30 days for the surety or trust provider to investigate the claim and an additional 30 days to make payment or denial (citing reason) to claimant: 60 days to advertise, plus an additional 60 days to investigate and settle claim.
Sureties or trust fund providers will have to commence action to cancel broker or freight forwarder surety bonds or trust funds in the event of broker/freight forwarder financial failure or insolvency (49 U.S.C. 13906(b)(6), (c)(7)). To effectively implement this provision, commenters provided other insights on surety or trust responsibilities in these cases.
A trade organization suggested that the requirements for the qualifications for trustees and trusts be sufficiently effective so that trustees are compelled to do better underwriting of brokers, eliminating those from the industry who may be likely to default on their payments to motor carriers.
A surety provider noted that the authority for pro-rata payments to claimants who have filed following publication of the need to file claims but before the cut-off date, should be explicitly set out in the regulations to protect the surety or trust and eliminate any delay in making payments to motor carriers.
The agency sought input on the development of surety suspension procedures authorized pursuant to 49 U.S.C. 13906(b)(7) and (c)(8). FMCSA has authority under MAP-21 to suspend non-compliant surety providers from providing broker or freight forwarder financial responsibility for 3 years, seek civil penalties against surety providers, and sue non-compliant surety providers in Federal court. In the ANPRM, the agency noted that it expects to establish a procedure for suspensions where it will issue an order to show cause against a non-compliant surety provider, weigh any evidence submitted by the provider, and make a final decision. (83 FR 48785)
A trade organization commented that FMCSA's enforcement authority is likely to be exercised mainly against sureties providing BMC-85 trusts since Treasury has authority to regulate sureties providing BMC-84 bonds. It supported the use of the simplified show cause procedure proposed by FMCSA, adding that the show cause order should be published to allow interested members of the public to comment. This trade organization recommended that, in order to ensure funds are available to pay motor carrier claims without a large expenditure of agency resources, the agency should require trust providers to issue only fully funded trusts and allow the market to regulate this by requiring the trustor to publish a list of valid claims paid on a publicly accessible website. According to the commenter, this information is currently required to be submitted to FMCSA, and the commenter believed there is no reason it should not also be made publicly available, so that motor carriers and others can see for themselves whether a trust provider is paying valid claims. The commenter wrote that the agency must make the distinction between “paid claims” and “filed claims.” Only valid claims paid should be required to be filed with the agency. This same trade organization commented that, in order to show that a trustee is holding $75,000 in cash or a cash equivalent for each of the brokers for whom it has filed a BMC-85, FMCSA should require the trustees to file audited financial statements with the agency showing the number of brokers for whom it has filed BMC-85 forms with the FMCSA, and the value and type of assets it is holding in trust to support them. The commenter said that FMCSA should make these audited financials publicly available so that the beneficiaries of these trusts can determine whether the trusts are fully funded with liquid assets “readily available to pay claims.” If they are not, then the Government should take enforcement action by cancelling the trust's registration number and terminating its ability to file BMC-85s.
A second trade organization laid out the surety's duties and procedures in detail in a draft proposed rule. The commenter believed these rules would define the limits of the surety's liability and remove any concerns that it must wait to collect all potential claims before paying claims on the bond. This trade organization encouraged FMCSA to adopt a process that would allow a member of the public to petition the agency to revoke the right of a surety or trustee to file bonds and trusts with the agency, if that surety or trustee has failed to follow the procedures in its draft § 387.307, Property broker surety bond or trust fund.
A surety provider wrote that a BMC-84 surety provider or BMC-85 trust fund provider becomes insolvent when it is unable to pay claims or redemptions upon demand. The commenter believed that when FMCSA can verify this, the agency should issue a notice to show cause and demand the surety provide proof of financial stability. If the surety is unable to adequately respond, FMCSA should issue a notice to the holders of the respective BMC-84s or BMC-85s that their “proof of minimum financial responsibility” will be suspended in 30 days if they do not obtain alternative surety filing.
A surety provider believed that FMCSA should suspend or revoke a surety or trust provider's authority to file BMC-84s or BMC-85s only if a written complaint with supporting evidence was filed with FMCSA, investigated, and ruled on by FMCSA as to suspension or revocation. The commenter stated that FMCSA must clearly define compliance rules before suspension or revocation is adopted practice.
A surety provider wrote that FMCSA must be certain any regulations or procedures it adopts do not conflict with Treasury's regulations in 31 CFR 223.17(b), regarding an agency's decision to refuse to accept a bond from a surety listed on OMB Circular 570. The commenter noted that, while FMCSA may determine that the Treasury procedure is enough, U.S. Customs and Border Protection has regulations outlining how that agency determines when to refuse to accept a surety's bond (19 CFR 113.38), without creating a referral to Treasury for
A surety provider believed if any trust provider is found not to be holding the funds required in support of the aggregated trusts they have underwritten or if a surety loses its authority granted by Treasury, that provider should immediately lose its authority to provide bonds or trusts. However, since suspension of the surety or trust will impact all of the principals for bonds issued by that surety or trust, the matter must be taken seriously and not be solely triggered by a complaint. The commenter believed the agency should provide the surety or trust with a notice to show cause why its authority should not be suspended, together with a list of particulars, and should provide the surety or trust with an opportunity for a hearing. The commenter said that if the agency has concerns, industry would expect it to initiate a dialogue so that the surety or trust might address those concerns before it reaches a show cause condition.
A surety provider recommended that FMCSA provide bond and trust providers the ability to post information related to surety suspension procedures on the FMCSA website, or to have the information sent to the FMCSA for posting.
Commenters provided other views related to FMCSA's enforcement authority. A trust fund provider noted that “the lone imploding BMC-85 provider, Oasis Capital, Inc., which exited the marketplace owing claimants and redemptions, was a singular event.” This commenter maintained that there is no other evidence of BMC-85 providers not paying claims or not providing redemptions to their customers. By contrast, another commenter asserted that there is evidence, revealed by a Google search, that BMC-85 providers have failed to pay legitimate claims. It also reported no claim issues can be found doing similar online searches for BMC-84 providers.
Another trade organization urged the agency to require all BMC-85 trust providers to submit timely notice of the financial failure of any of their clients and to make information regarding claims paid publicly available. The commenter wrote that underfunded or insolvent trust fund providers “tarnish the brokerage industry and disadvantage those operating legally, enable irresponsible brokers to continue operating without adequate security, and cheat motor carriers, thereby lessening the safety of the transportation industry.” The commenter reported that when owner-operators do not get paid, they may not be able to invest adequately in maintenance and safety improvements. The commenter wrote that FMCSA must enforce the law and give its highest priority to ensuring that trust providers are fully funded.
While it understood that the agency focus is on safety, a trade organization believed that the economic well-being of small business motor carriers has a huge impact on safety because the loss of one payment can cause a motor carrier to defer maintenance and run harder until it makes up the shortfall. The commenter provided suggested regulatory text that it believed would keep persons with little financial backing from entering the broker industry, reducing the need for FMCSA enforcement action.
Under MAP-21, FMCSA has broad authority to determine who is eligible to provide trust fund services on behalf of brokers or freight forwarders. A broker must file a surety bond or trust fund from a provider “determined by the Secretary to be adequate to ensure financial responsibility” (49 U.S.C. 13906(b)(1)(A)). Section 13906(c)(1)(A) contains similar language for freight forwarders. Under current regulations, a financial institution may file trust funds (§ 387.307). In addition to other types of entities, loan or finance companies are considered financial institutions pursuant to § 387.307(c)(7). In the ANPRM, the agency asked whether FMCSA should require BMC-85 trust fund providers to be licensed as trust providers. It also asked how § 387.307(c)(7) (loan or finance company) could be amended to ensure adequate monitoring of BMC-85 providers' ability to pay claims.
A number of commenters believed that providers of BMC-85 trust funds should be licensed as trust providers.
A surety provider believed that, while requiring BMC-85 trust providers to become licensed trust providers would add further regulatory oversight, the government agencies that provide the trustee licenses would not enforce or know the proper amount of assets that the trustees should have in trust. The commenter wrote that FMCSA needs to provide further oversight of the BMC-85 trusts. The commenter reported that when the BMC-85 trust providers were directly asked at the May 2016 roundtable if they were collecting $75,000 to be held in trust, none claimed they were. Instead, they collect a small percentage annual fee, akin to unlicensed surety bonds, with none of the regulatory oversight or safeguards. The commenter wrote that a trust license requirement would not change this, but oversight and regulation from the FMCSA could.
A trade organization endorsed the previously filed comments of the Association of Independent Property Brokers & Agents and quoted from them extensively regarding what it believed is a conflict-of-interest issue regarding “the current practice of non-profit entities engaging in the normally for-profit business of selling or the brokering of financial security.” The commenter believed that instead of working to fulfill important MAP-21 mandates, industry had been asked to “engage in furtherance of what we believe is nothing more than a trust fund supplier `witch hunt' asked for by competing BMC-84 bond issuers and/or other entities that represent themselves as bona fide, non-profit trade groups, but are actually for-profit BMC-84 bond peddlers in disguise.” The commenter recommended that FMCSA restrict industry trade groups from selling financial security instruments.
A surety provider suggested FMCSA consider promulgating regulations establishing financial criteria that FMCSA believes BMC-85 trust funds should meet. FMCSA could then require annual reports by independent accountants from every BMC-85 trust company that wants to obtain filer authority, verifying that these criteria had been met. If the company did not provide this annual report, its authority would be revoked. The BMC-85 trust company would need to have assets readily available that exceed the liability for trust funds on deposit. The commenter believed a process like this would be relatively easy for FMCSA to monitor.
A trade organization demanded a change to the licensing process because of the lack of a qualified, independent monitoring source and false reliance on a State's initial issuance/reissuance of its business license. The commenter believed that loan or finance companies should not be treated as financial institutions, because of concerns that States will not monitor BMC-85 providers' ability to pay claims from a trust or, further, monitor such companies for enforcement purposes. The commenter also believed that the National Insurance Producers Registry license is only an industry-sponsored listing service of insurance agents and brokers.
In regard to the comment suggesting that trustees be required to have annual reports from independent accountants to measure their compliance with FMCSA regulations, FMCSA believes that such a requirement would impose cost upon trustees that is unnecessary. FMCSA believes that the proposed regulatory structure, where trusts will need to contain high quality financial instruments that are available to meet $75,000 in claims, along with the enhancement of the regulatory requirements for being a BMC-85 trustee, will make such an annual reporting requirement unnecessary.
Finally, FMCSA agrees with commenter's suggestion that being a loan or finance company is not sufficient to serve as a BMC-85 trustee. Through its outreach to financial regulators and their representatives, FMCSA has received robust feedback that loan or finance companies are not adequately regulated and hence inappropriate for serving as stewards of money held in trust for motor carriers and shippers.
The agency anticipated the need for revisions to the BMC-84 and BMC-85 forms if a rulemaking was proposed. In the ANPRM, FMCSA requested comments to identify suggested changes to the forms.
After review of the BMC-84, a trade organization found it to be well drafted. The commenter's only recommendation was that the form require the surety underwriting the bond to be a corporation appearing on Treasury's list of approved sureties and certified, pursuant to 31 U.S.C. 9304 through 9308, to provide bonds to the Federal Government.
A surety provider suggested that the best approach to revising the forms would be incorporating regulatory language by reference, rather than repeating language found in the FMCSA regulations.
Two surety providers believed there is no need to modify the forms except to conform to changes from rulemaking.
A trade organization encouraged the agency, if it does change these forms or adopt an electronic version for filing, to revise them to state that “no provision on the form or in a contract or agreement between a broker and a surety or trustee, or a contract or agreement between a broker and motor carrier, can conflict with or exempt any party from their rights or duties under the new rules. Nor can any such contract bind a person to waive their rights or duties under the new rules.” The commenter also believed the forms should state that the contract includes by reference all applicable provisions of 49 U.S.C. 13906 and the regulations themselves. The commenter also noted that electronic filing of some fields from the physical documents has caused confusion as to the contents of the form. There are provisions on the BMC-84 setting legal responsibilities and liabilities that are not provided by the current statute or regulations.
A surety provider believed that removing the 30-day cancellation clause, allowing a trust or bond company to cancel on demand, will reduce the number of claims and lower premiums.
FMCSA asked whether HHG brokers and freight forwarders should be regulated differently than general property brokers and freight forwarders in a rulemaking on broker/freight forwarder financial responsibility. Two surety providers believed that HHG brokers should be regulated differently. One commenter noted that the movement of HHG deals directly with the public. The second commenter also noted that HHG shippers are consumers who know very little about the transportation industry. This commenter wrote that in its experience this segment of the industry often violates existing regulations regarding estimates and carriers holding loads hostage. It suggested that enforcement of the existing regulations would reduce those problems.
A surety provider wrote that, from an underwriting standpoint, it is unlikely that the surety industry will view HHG differently. The surety market underwriters already have the ability to segregate policies based on their operations and have chosen not to do so.
A trade organization representing the moving industry believed that any additional fraud protections imposed by FMCSA should apply only to online HHG brokers. A second trade organization representing the moving industry did not believe that additional fraud protections pertaining to HHG brokers were warranted.
FMCSA sought comment on whether the market is able to address broker/freight forwarder noncompliance. For example, if a broker or freight forwarder has a history of noncompliance with contracts, wouldn't surety or trust firms be less likely to back them, or to charge a higher premium or trust fund management fee? Is there a market
Three surety providers agreed that sureties would decline to provide BMC-84s or BMC-85s to any broker or freight forwarder with a known history of noncompliance with a BMC-84 or BMC-85, except under special circumstances. These commenters reported that the problem is with reincarnated brokers and freight forwarders that slip through the process. One of these commenters wrote that sureties collect a variety of personal identification information as part of the underwriting process to ferret out reincarnated entities, but this does not always prevent these entities from finding another surety, because such information cannot be disclosed unless the surety is required to provide it to the agency. Another of these surety providers believed that a consolidated public posting of the MC number, company name, and name of the owner(s) of noncompliant brokers and freight forwarders would help combat reincarnated companies.
A surety provider noted that the whole industry should vet the broker or freight forwarder using FMCSA's Licensing and Insurance website, before entering any monetary relationship.
FMCSA requested comments on any other aspects of implementing MAP-21 section 32918 that may be necessary, including how these areas could be implemented in a way that would not divert scarce safety oversight resources.
One trade organization offered detailed proposed regulatory text. It suggested that FMCSA's primary role in an NPRM would be to promptly publish on its Licensing and Insurance website: (1) information provided by sureties about when a broker obtains a bond or trust that complies with the rules; (2) information regarding the status of the broker's registration; and (3) the website link provided by the surety with which the public can obtain information about the current bond. By making public timely information about pending bond claims and the status of a broker's registration, the commenter wrote that the motor carrier can choose whether to do business with a broker or not.
A surety provider indicated that a license as a premium financing company, available in all 50 States, with oversight by each State's department of insurance or banking department, would relieve FMCSA of the need for an annual review, leaving its limited resources available for safety oversight. The commenter included a table describing the licensing requirements for each State.
A surety provider believed that limiting the acceptable financial instruments to BMC-84 surety bonds is the best way to ensure that FMCSA does not divert its resources because the BMC-84 bond is the only product that relies strictly on other government agencies for solvency and claims handling. The commenter maintained that BMC-84 surety bonds are less expensive than BMC-85 trusts. The same commenter wrote that while there are thousands of bond requirements similar to the $75,000 freight broker bond at the local, State, and Federal level, the Government agencies issuing the requirements rely on other Government agencies to regulate the companies backing the risk, which allows them to focus on their regulatory duties. For surety bonds (BMC-84), third party trusts (BMC-85), ILOCs from FDIC-insured banks, and cash, the commenter provided two tables describing which Government agencies regulate each product and what percentage of obligees accept each product. The commenter noted that FMCSA is the only Government agency that allows third-party trust companies to hold the ILOCs or cash on behalf of the agency, greatly adding to FMCSA's oversight responsibilities.
FMCSA requested comment on the small business impacts of its suggested courses of action in the ANPRM. An individual commenter believed this to be the single most crucial question the agency asked. He reported that small business truckers must be fully compensated in order to operate safely; if they are not justly compensated for their efforts, they have been failed by the system which is in place to protect them.
A trust fund provider noted that thousands of freight brokers are small business owners; any disruption to their bond placement or in their potential authority status may result in lost revenues. The commenter also wrote that many BMC-85 providers also qualify as small businesses that could be put out of business if FMCSA adopts a cash-only standard for BMC-85 trust funds.
A surety provider wrote that, if BMC-85s continue to be offered as an option, FMCSA must communicate where to report claim issues and must handle complaints in a timely fashion or small freight carriers will continue to be forced to close. The commenter added that only FMCSA can positively impact small freight carriers that have been harmed by the lack of BMC-85 trust regulation.
Some commenters raised issues or offered explanations that were related to broker/freight forwarder financial responsibility but outside the specific issues that FMCSA raised in the ANPRM. A trade organization proposed regulatory language to ensure that a broker operates and incurs debt to motor carriers only when it has the amount of security required by statute. This commenter asked for industry input on the reasons for a legitimate dispute between a broker and carrier over payment of a load so they could be incorporated into the regulations. Other than claiming that it did not contract with the broker, the commenter believed that the only legitimate dispute would be one where the shipper or receiver of the load in question had memorialized a claim in a document given to the broker stating with particularity that the motor carrier did not perform the transportation as agreed to. The commenter noted that, when brokers go out of business with claims exceeding the amount of the bond, those claims are rarely the subject of a dispute between the broker and the carrier.
This same commenter noted that these financial security rules are important for the smooth function and safety of the motor carrier industry. If the rulemaking produces effective steps for the resolution of motor carrier claims against a bond or trust, this trade organization believed that “disputes between motor carriers and sureties will be reduced, there will be less need for litigation, less need for FMCSA intervention, and the economic health of the broker/motor carrier component of the transportation industry will be stronger.”
In response to the agency's assertion that FMCSA had heard little from the BMC‐85 industry, a trust fund provider complained that FMCSA had failed to consider his comment properly. In his June 16, 2016 post-round table comments, this surety provider wrote that his company “reiterates and incorporates the entirety of PFA's post-event `comments regarding the FMCSA roundtable on May 20, 2016.' ” This same surety provider believed that FMCSA did not appropriately distinguish between the legitimate interests of motor carriers and shippers and the “often questionable benefits” of BMC-84 surety providers.
A factoring company noted that it endorsed the submissions of Transport Financial Services. The commenter wrote that attendees at a transportation factoring software users conference agreed that BMC-85 trust providers are preferable to BMC-84 surety providers with respect to economically regulated transportation claims processing and better informed regarding such specialized activity than the licensed insurance adjusters handling a much wider range of claims. A surety provider believed a rulemaking alone would not provide the adequate changes needed to solve the issues posed by BMC-85s.
Commenters believed that FMCSA should do more to screen brokers. An individual wrote that FMCSA should require more proof of financial stability from brokers, and the broker or forwarder should prove this to the shipper too. The commenter recommended creating a reporting portal that would provide a track record of issues with on time payments or other issues that FMCSA could investigate and act on.
One individual believed that FMCSA is not doing enough to vet brokers that fail to pay carriers and then close their doors, change their business name, and/or file for bankruptcy, leaving the surety to handle the debt. The commenter wrote that FMCSA needs to collect the social security number of the brokers, their spouses, and managing partners and then create a database to monitor and even reject “fly by night” operations. The commenter recommended that FMCSA make it a criminal act to lie on the property broker application and provided examples of questions intended to weed out chameleon brokers.
A number of commenters believed that the bond amount should be higher than $75,000. However, one trade organization commented that the $75,000 bond is too high and serves as an unreasonable barrier to entry. It recommended it be lowered by Congress to $25,000. Another surety provider wrote that raising the financial requirement for brokers and freight forwarders only increased the amount of money unscrupulous operators could steal.
This NPRM proposes to allow brokers and freight forwarders to meet MAP-21's assets readily available requirement by maintaining trusts that have assets that can be liquidated within 7 business days of the event that triggers a payment from the trust, as certified on a BMC-85, and that do not contain the following assets:
(1) Interests in real property;
(2) Intercorporate agreements or guarantees;
(3) Internal Letters of Credit;
(4) Certain assets determined by States to be illiquid including second trust deeds, personal property and vehicles;
(5) Bonds that do not receive the highest rating from a credit rating agency (a nationally recognized statistical rating organization registered with the Securities and Exchange Commission); and
(6) Any other asset that the broker cannot certify (on a BMC-85) will be available in the amount of $75,000 within 7 business days.
After consideration of the 2016 roundtable discussion and associated comments and the comments in response to the 2018 ANPRM, FMCSA proposes the list of assets that are not suitable for a BMC-85 trust fund above.
First, the Agency believes that 7 business days is a reasonable period for an asset to be considered “readily” available for liquidation. That will give the broker or freight forwarder adequate time to convert the asset to cash (if not cash already) but it will be available for claimants within a reasonably short period, and indeed quicker than routine collection of commercial debt in other contexts.
Second, FMCSA carefully developed the list of assets that it will not consider to be “assets readily available.” It addresses each of these in turn.
FMCSA does not believe interests in real property should be in BMC-85 trust funds as such interest may be difficult to liquidate within 7 business days. Moreover, the value of real property fluctuates, and FMCSA is concerned that an interest in real property initially worth $75,000 will not retain its value at the time of a claim on a bond or trust.
Second, intercorporate guarantees or agreements are dependent on the financial health of the guarantor, which makes their availability in the case of a drawdown uncertain. In addition, FMCSA lacks the information and resources to monitor the financial health of guarantors.
Third, FMCSA does not believe internal letters of credit are appropriate for BMC-85s. In order for FMCSA to accept letters of credit in BMC-85 trust funds, the Agency needs to be confident that the issuer of the letter of credit is able to pay a claim in the event of a drawdown. Internal letters of credit do not appear to provide such reassurance. FMCSA is aware that a leading trust fund provider uses internal letters of credit in its trust funds, and the agency welcomes comments on how it can be assured that such letters of credit will be available for the payment of claims.
Fourth, in preparing this proposed rule, FMCSA explored whether States have defined assets readily available. FMCSA learned that at least two States have considered second trust deeds, personal property, and vehicles to be
Fifth, FMCSA has determined that given their higher default risk, bonds that are not considered the highest rated by a nationally recognized statistical rating organization (NRSRO),
Finally, to provide maximum flexibility for BMC-85 trust providers and brokers and freight forwarders, FMCSA will allow all other assets in trusts, provided the broker or freight forwarder can certify under penalty of perjury that the asset will be convertible to cash within 7 business days of the event triggering its liquidation. This rule also proposes a 3-year compliance date to give time for brokers or freight forwarders to meet the new asset requirement. FMCSA believes this will allow brokers and freight forwarders to transition to the new standard.
FMCSA invites comments from the public regarding other types of assets that should not be considered assets readily available. FMCSA also requests comments from the public regarding whether a comprehensive list of appropriate assets is possible or desirable.
FMCSA proposes removing loan and finance companies from the list of entities authorized to serve as BMC-85 trustees. FMCSA reaches this conclusion for several reasons. First, FMCSA is not a financial regulator, and given its primary safety mission it must rely on other regulators to regulate the trustees that provide BMC-85 trust funds. In that regard, FMCSA is concerned that loan and finance companies are not adequately regulated at the State level for the purpose of issuing BMC-85s. Because these entities are unregulated, they may engage in practices that create risk to the public. Specifically, many of these loan and finance companies offer access to a $75,000 trust via a monthly membership fee. This business model is not within the intent of MAP-21 and may not provide the readily available assets to pay claims. Its meetings with both State and Federal regulators were informative on this point. CSBS indicated that loan companies are not looked at for safety and soundness or financial condition. They are generally examined for consumer protection compliance. Moreover, there are too many companies for the amount of state examination capacity. The FDIC indicated that state finance companies are not regulated as robustly as FDIC insured banks. And, the Florida Office of Financial Regulation, which regulates Florida “consumer finance companies,” one of which is a significant provider of BMC-85 trusts, indicated that there is no regulation of these companies in the business that FMCSA allows them to be engaged in. FMCSA welcomes comments from BMC-85 providers and others as to why loan and finance companies are adequately regulated for the purpose of issuing BMC-85s, as opposed to being regulated by states for either purpose.
FMCSA also proposes a 3-year compliance date for trustees to meet these new requirements to allow BMC-85 providers to transition.
FMCSA does not currently allow the use of group surety bonds or group trust funds (78 FR 54720, 54721, Sept. 5, 2013), and this NPRM does not propose any changes to the agency's position. After considering the comments on the ANPRM and additional agency discussion, FMCSA determined that the use of these bonds and funds would not be likely to provide a cost savings for brokers and freight forwarders, as brokers and freight forwarders would still need to hold $75,000 in financial responsibility. In addition, group surety bonds/trust funds are difficult and costly to administer. As noted in the comment discussion, the main proponent of their inclusion in implementation of 49 U.S.C. 13906(b) and (c) has since acknowledged that they are inappropriate for FMCSA financial responsibility requirements, a factor which FMCSA finds highly persuasive.
FMCSA proposes a new process for an immediate suspension of broker or freight forwarder operating authority. If there is an actual drawdown on a broker/freight forwarder surety bond or trust fund, FMCSA will provide notice to the broker or freight forwarder that it has 7 business days to provide evidence to FMCSA that the surety or trust has been replenished. If it does not provide such notice, FMCSA will suspend that broker or freight forwarder's operating authority registration.
A drawdown would be defined as a situation where one of the following occurs: (1) a broker or freight forwarder consents to the drawdown and the instrument value drops below $75,000; (2) a broker or freight forwarder does not respond to adequate notice of a claim by a surety or trust fund provider, the surety or trust provider pays the claim, and the instrument value drops below $75,000; or (3) a claim is reduced to a judgment, the surety or trust fund provider pays the judgment and the instrument value drops below $75,000.
This proposal also requires that FMCSA provide the broker or freight forwarder notice of the pending suspension and give it 7 business days to replenish the funds. If it does not replenish the funds, the broker's or freight forwarder's registration will be suspended via second notice. FMCSA believes that 7 business days gives the broker or freight forwarder reasonable time to replenish the surety bond or trust account, while also implementing Congress's mandate that broker or freight forwarder operating authority registration be immediately suspended in the event the broker/forwarder's financial security falls below $75,000.
FMCSA proposes to define
Consistent with FMCSA's primary safety mandate, the agency seeks to implement this statute in a way that involves clear guidelines for surety and trust providers with minimal agency involvement is. FMCSA believes this proposal accomplishes that goal. To the extent that brokers, sureties, or trustees are concerned about the bankruptcy implications of this approach, FMCSA recognizes that those entities may need to seek relief from the bankruptcy court to take action on the BMC-84 or BMC-85 instruments in the event of a bankruptcy. Given that a formal bankruptcy or insolvency filing is required, FMCSA expects few instances where this portion of the NPRM will be triggered.
Further, MAP-21 requires that sureties or trustees “publicly advertise” for claims in the event of a broker or freight forwarder financial failure or insolvency. FMCSA proposes that once the surety or trustee has notified FMCSA of the financial failure or insolvency, it will have met its statutory mandate to “publicly advertise.” FMCSA will help ensure that claimants are aware of the claims filing period by posting notice of the claims period on the FMCSA Register on its website. All claims will need to be filed directly with the surety or trustee.
FMCSA proposes to implement MAP-21's surety provider suspension authority provision by providing notice of suspension to the surety or trust fund provider, allowing 30 calendar days (extended to the next business day if the final day of the period falls on a weekend or Federal holiday) for the surety or trust provider to respond, before the agency makes a final decision.
FMCSA proposes to add language to 49 CFR part 386 to address civil penalties authorized by 49 U.S.C. 13906(b) and (c) as well.
This section includes a summary of the proposed changes to 49 CFR parts 386 and 387. The regulatory changes proposed are discussed in numerical order.
In Appendix B to part 386, a new paragraph (g)(24) would be added to highlight the monetary penalty for which a surety company or financial institution found in violation of 49 U.S.C. 13906 or § 387.307 would be liable.
In § 387.307(b), a new standard for trust funds allowed under the section would be added. Existing paragraph (c)(7) would be removed and existing paragraph (c)(8) would be renumbered as paragraph (c)(7). New paragraphs (e), (f), and (g) would be added.
Paragraph (e) would set out the triggers and procedures for immediate suspension of a broker. The paragraph would establish the role of the surety provider or financial institution, FMCSA, and the broker.
Paragraph (f) would set out procedures and responsibilities for a surety company or a financial institution and FMCSA following financial failure or insolvency of a broker. A financial failure or insolvency of a broker would be defined as a filing related to the broker pursuant to Title 11 of the United States Code or a filing related to the broker under an insolvency or similar proceeding under State law.
Paragraph (g) would set out procedures concerning suspension of a surety company or financial institution's ability to file evidence of financial responsibility with FMCSA and FMCSA's role in that action. Penalties for violation of the requirements of this section or subsection (b) of Title 49, section 13906 U.S.C. would be established.
The Office of Information and Regulatory Affairs (OIRA) determined that this rulemaking is not a significant regulatory action under section 3(f) of E.O. 12866 (58 FR 51735, Oct. 4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, Jan. 21, 2011), Improving Regulation and Regulatory Review and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. This rule is also not significant within the meaning of DOT regulations (49 CFR 5.13(a)). Accordingly, the Office of Management and Budget has not reviewed it under these Orders. A draft regulatory impact analysis is available in the docket. That document:
• Identifies the problem targeted by this rulemaking, including a statement of the need for the action.
• Defines the scope and parameters of the analysis.
• Defines the baseline.
• Defines and evaluates the costs and benefits of the action.
Copies of the full analysis are available in the docket or by contacting the person listed under
Brokers and freight forwarders, surety bond and trust fund providers, and the Federal Government would incur costs for compliance and implementation. The quantified costs of the proposed rule include notification costs related to a drawdown on a surety bond or trust fund, and immediate suspension proceedings, FMCSA costs to hire new personnel, and costs associated with the development and maintenance of the BMC-84/85 Filing and Management IT System. FMCSA estimates that the 10-year cost of the proposed rule would total $5.4 million on an undiscounted basis, $3.8 million discounted at 7 percent, and $4.6 million discounted at 3 percent (all in 2020 dollars). The annualized cost of the rule would be $545,505 discounted at 7 percent and $542,343 at 3 percent. Ninety-eight percent of the costs would be incurred by the Federal Government.
This proposed rule would result in benefits to motor carriers amounting to a decrease in the claims that go unpaid. FMCSA expects this result for a number of reasons. First, FMCSA proposes to immediately suspend brokers that do not respond following a drawdown on their financial security. This step should alleviate broker non-payment issues as financially insecure brokers would have less time to run up claims they may never pay, while operating lawfully. Building the BMC-84/85 Filing Management System would efficiently exchange information between motor carriers, brokers, financial responsibility providers, and FMCSA, thereby reducing the information asymmetry concerns associated with broker and carrier transactions. Given a lack of data, FMCSA is unable to quantify benefits resulting from this rule, but qualitatively discusses benefits directly
FMCSA cannot directly estimate an impact on safety resulting from the proposal. OOIDA
Pursuant to the Congressional Review Act (5 U.S.C. 801-808), the Office of Information and Regulatory Affairs (OIRA) designated this rule as not a “major rule.”
Under 49 U.S.C. 31136(g), FMCSA is required to publish an ANPRM or proceed with a negotiated rulemaking, if a proposed rule is likely to lead to the promulgation of a major rule. However, this requirement does not extend to rulemakings promulgated under the agency's jurisdiction pursuant to 49 U.S.C. 13501 or 13531, which are the basis of this rulemaking. Nonetheless, on September 27, 2018, FMCSA voluntarily published an ANPRM (83 FR 48779).
The Regulatory Flexibility Act of 1980, Public Law 96-354, 94 Stat. 1164 (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857, Mar. 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240, 124 Stat. 2504, Sept. 27, 2010), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and 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. Accordingly, DOT policy requires an analysis of the impact of all regulations on small entities, and mandates that agencies strive to lessen any adverse effects on these businesses. FMCSA has not determined whether this proposed rule would have a significant economic impact on a substantial number of small entities. Therefore, FMCSA is publishing this initial regulatory flexibility analysis (IRFA) to aid the public in commenting on the potential small business impacts of the proposals in this NPRM. We invite all interested parties to submit data and information regarding the potential economic impact that would result from adoption of the proposals in this NPRM. We will consider all comments received in the public comment process when making a determination in the Final Regulatory Flexibility Assessment.
An IRFA must contain the following:
1. A description of the reasons why the action by the agency is being considered;
2. A succinct statement of the objective of, and legal basis for, the proposed rule;
3. A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply;
4. A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record;
5. An identification, to the extent practicable, of all relevant Federal rules that may duplicate, overlap, or conflict with the proposed rule; and
6. A description of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities.
In 2012, Congress enacted MAP-21, specifically, section 32918, which contained requirements for the financial security of brokers and freight forwarders that amended 49 U.S.C. 13906. FMCSA proposes modifications to broker and freight forwarder financial responsibility requirements in accordance with the MAP-21 mandate. On September 27, 2018, FMCSA published an ANPRM (83 FR 48779) saying that the agency was considering changes or additions to eight separate areas: Group surety bonds/trust funds, assets readily available, immediate suspension of broker/freight forwarder operating authority, surety or trust responsibilities in cases of broker/freight forwarder financial failure or insolvency, enforcement authority, entities eligible to provide trust funds for form BMC-85 trust fund filings, Form BMC-84 and BMC-85 trust fund revisions, and HHG.
In 2012, Congress enacted section 32918 of MAP-21, which contained requirements for the financial security of brokers and freight forwarders, amending 49 U.S.C. 13906. Congress mandated that the agency issue a rulemaking to implement the new statutory requirements MAP-21 section 32918(b). Congress mandated that FMCSA conduct rulemaking to implement the statutory changes. The objective of this rulemaking is to complete the implementation of Congress's directive and to help ensure that motor carriers are paid for the services they provide for brokers and freight forwarders.
This proposed rule would affect financial responsibility providers, brokers, and freight forwarders.
The financial responsibility providers that would be affected by this proposed rule operate under many different North American Industry Classification System
Brokers and freight forwarders operate in the transportation sector under the NAICS code 48851. As shown in Table 2, the SBA size standard for freight transportation arrangement is $16.5 million in revenue.
FMCSA examined data from the 2017 Economic Census, the most recent Census for which data were available, to determine the percentage of firms that have revenue at or below SBA's thresholds within each of the NAICS industries.
The commercial banking industry group has a revenue size standard of $600 million. The largest Economic Census revenue category is $100 million or more. As such, FMCSA could not determine the percent of entities within this NAICS industry group that would be considered small, and conservatively estimates that all commercial banking entities are small entities as defined by the SBA.
For Other Nondepository Credit Intermediation, the $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of Other Nondepository Credit Intermediates with revenue less than these amounts were 50 percent and 54 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of these entities that are small will be closer to 50 percent and is using that figure.
The Securities Brokerage industry group focuses on underwriting securities issues and/or making markets for securities and commodities. The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of Securities Brokerages with revenue less than these amounts were 97 percent and 98 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of securities brokerages that are small will be closer to 97 percent and is using that figure.
The Commodity Contracts Dealing industry group focuses on acting as
The Commodity Contracts Brokerage industry group focuses on providing securities and commodity exchange services (52314). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of commodity contracts brokers with revenue less than these amounts were 84 percent and 86 percent. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of commodity contracts brokers that are small will be closer to 84 percent and is using that figure.
The Securities and Commodity Exchanges industry group provides marketplaces and mechanisms for the purpose of facilitating the buying and selling of stocks, stock options, bonds or commodity contracts (52321). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. There are 13 total firms that operated for the entire year under the securities and commodity exchanges industry group, but the Census has redacted the number of firms with revenue less than $100 million. The Census reports that there are four firms with revenue of $100 million or greater, which leads FMCSA to estimate that there are nine firms with revenue below $100 million. FMCSA conservatively estimates that all nine firms with revenue below $100 million (69 percent of the industry group) are considered small.
The Miscellaneous Intermediation industry group primarily engages in acting as principals in buying or selling of financial contracts (52391). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of miscellaneous intermediation firms with revenue less than these amounts were 97 percent and 99.6 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of miscellaneous intermediates that are small will be closer to 97 percent and is using that figure.
The Direct Property and Casualty Insurance Carriers industry group primarily engages in initially underwriting insurance policies (524126). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of direct property and casualty insurance carrier firms with revenue less than these amounts were 81 percent and 88 percent. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of direct property and casualty insurers that are small will be closer to 81 percent and is using that figure.
The Direct Title Insurance Carriers industry group primarily engages in initially underwriting title insurance policies (524127). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of direct title insurers with revenue less than these amounts were 66 percent and 67 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of direct title insurers that are small will be closer to 66 percent and is using that figure.
The Other Direct Insurance Carriers industry group primarily engages in initially underwriting insurance policies (524128). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of other direct insurance carriers with revenue less than these amounts were 58 percent and 63 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of other direct insurance carriers that are small will be closer to 58 percent and is using that figure.
The Reinsurance Carriers industry group primarily engages in assuming all or part of the risk associated with insurance policies originally underwritten by a different provider (52413). The SBA size standard for this industry group is $41.5 million. The $41.5 million SBA threshold falls between two Economic Census revenue categories, $10 million and $100 million. The percentages of reinsurance carriers with revenue less than these amounts were 49 percent and 60 percent, respectively. The SBA threshold is not near either of these revenue categories, FMCSA conservatively estimates that the percent of reinsurance carrier firms that are small will be closer to 60 percent and is using that figure.
The Insurance Agencies and Brokerages industry group primarily engages in selling insurance (52421). The SBA size standard for this industry group is $8 million. The $8 million SBA threshold falls between two Economic Census revenue categories, $5 million and $10 million. The percentages of insurance agencies and brokerages with revenue less than these amounts were 98 percent and 99 percent, respectively. Because the SBA threshold is closer to the higher of these two boundaries, FMCSA has assumed that the percent of insurance agencies and brokerages that are small will be closer to 99 percent and is using that figure.
The Third Party Administration of Insurance and Pension Funds industry group primarily engages in providing third-party administrative services of insurance (524292). The SBA size standard for this industry group is $35 million. The $35 million SBA threshold falls between two Economic Census revenue categories, $25 million and $100 million. The percentages of firms with revenue less than these amounts were 92 percent and 97 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of firms that are small will be closer to 92 percent and is using that figure.
The Freight Transportation Arrangement industry group primarily engages in arranging the transportation of freight between shippers and carriers (48851). The SBA size standard for this industry group is $16.5 million. The $16.5 million SBA threshold falls between two Economic Census revenue categories, $10 million and $25 million. The percentages of firms with revenue less than these amounts were 93 percent and 97 percent, respectively. Because the SBA threshold is closer to the lower of these two boundaries, FMCSA has assumed that the percent of firms that are small will be closer to 93 percent and is using that figure.
Table 3 below shows the complete estimates of the number of small entities within the NAICS industry groups that
This NPRM would include recordkeeping requirements pertaining to small financial responsibility providers and brokers. These entities would be required to provide notification to FMCSA of specific activity on a broker bond or trust fund. FMCSA anticipates that these notifications can be completed by office clerks.
FMCSA attempted to draft a proposed rule that would minimize any significant economic impact on small entities. FMCSA is proposing a 3-year compliance date in an effort to allow ample time for small entities to meet the requirements of the rule. This compliance date takes into account the resources available to small entities. FMCSA is not aware of any significant alternatives that would meet the intent of our statutory requirements but nevertheless requests comment on any alternatives that would meet the intent of the statute and prove cost beneficial for small entities.
FMCSA is not a covered agency as defined in section 609(d)(2) of the Regulatory Flexibility Act and has taken no steps to minimize the additional cost of credit for small entities.
FMCSA requests comments on all aspects of this initial regulatory flexibility analysis.
In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996,
Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business Administration's Small Business and Agriculture Regulatory Enforcement Ombudsman (Office of the National Ombudsman, see
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) requires Federal agencies to assess the effects of their discretionary regulatory actions. 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 $178 million (which is the value equivalent of $100 million in 1995, adjusted for inflation to 2021 levels) or more in any 1 year. Though this NPRM would not result in such an expenditure, and the analytical requirements of UMRA do not apply as a result, the agency discusses the effects of this proposed rule elsewhere in this preamble and in the regulatory impact analysis available in the docket.
This proposed rule does not propose new information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The agency is not proposing any changes to Forms BMC-84 and BMC-85 at this time but will consider whether it needs to modify Forms BMC-84 and BMC-85 after reviewing the comments on this NPRM. Should revisions to the
A rule has implications for federalism under section 1(a) of E.O. 13132 if it has “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
FMCSA has determined that this rule would not have substantial direct costs on or for States, nor would it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Impact Statement.
The Consolidated Appropriations Act, 2005,
The E-Government Act of 2002,
No new or substantially changed technology would collect, maintain, or disseminate information as a result of this rule. Accordingly, FMCSA has not conducted a PIA.
In addition, the agency submitted a Privacy Threshold Assessment to evaluate the risks and effects the proposed rulemaking might have on collecting, storing, and sharing personally identifiable information. The DOT Privacy Office has determined that this rulemaking does not create privacy risk.
This rule does not have Tribal implications under E.O. 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.
FMCSA analyzed this proposed rule pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
Administrative practice and procedure, Brokers, Freight forwarders, Hazardous materials transportation, Highway safety, Motor carriers, Motor vehicle safety, Penalties.
Buses, Freight, Freight forwarders, Hazardous materials transportation, Highway safety, Insurance, Intergovernmental relations, Motor carriers, Motor vehicle safety, Moving of household goods, Penalties, Reporting and recordkeeping requirements, Surety bonds.
For the reasons set forth in the preamble, FMCSA proposes to amend 49 CFR parts 386 and 387 as follows:
28 U.S.C. 2461 note; 49 U.S.C. 113, 1301 note, 31306a; 49 U.S.C. chapters 5, 51, 131-141, 145-149, 311, 313, and 315; and 49 CFR 1.81, 1.87.
(g) * * *
(24) A surety company or financial institution for a broker or freight forwarder pursuant to §§ 387.307 or 387.403T and violates subsection (b) or (c) of Title 49 of the United States Code, Section 13906 or § 387.307, is liable to the United States for a penalty of $10,000 for each violation.
49 U.S.C. 13101, 13301, 13906, 13908, 14701, 31138, 31139; sec. 204(a), Pub. L. 104-88, 109 Stat. 803, 941; and 49 CFR 1.87.
The revision and additions read as follows:
(b)
(e)
(2) Upon notification by the surety company or financial institution in accordance with paragraph (e)(1) of this section, FMCSA shall provide written notice to the broker that its operating authority issued pursuant to part 365 will be suspended within 7 business days of the date of the notice unless the broker provides written evidence to FMCSA that the surety bond or trust fund has been restored to the $75,000 amount required by this section. FMCSA will provide a second written notice to the broker of any suspension.
(f)
(2) Upon notification by the surety or financial institution, FMCSA shall immediately provide written notice of the cancellation in the FMCSA Register on its public website. The surety or financial institution shall accept claims against the BMC-84 surety bond or BMC-85 trust fund for 60 calendar days (extended to the next business day if the final day of the period falls on a weekend or Federal holiday) following FMCSA's public notification of the financial failure or insolvency in the FMCSA Register.
(g)
(2) If FMCSA initiates a suspension action pursuant to paragraph (g)(1) of this section it shall provide written notice to the surety company or financial institution, provide 30 calendar days (extended to the next business day if the final day of the period falls on a weekend or Federal holiday) for the surety company or financial institution to provide evidence contesting such proposed suspension, and then render a final decision in writing.
Issued under authority delegated in 49 CFR 1.87.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on stainless steel wire rods (SSWR) from India would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of this AD order.
Applicable January 5, 2023.
Christopher Williams or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5166 or (202) 482-1690, respectively.
On December 1, 1993, Commerce published in the
As a result of its review, Commerce determined, pursuant to sections 751(c)(1) and 752(c) of the Act, that revocation of the
The products covered by the
This merchandise is currently classifiable under subheadings 7221.00.0005, 7221.00.0017, 7221.00.0018, 7221.00.0020, 7221.00.0030, 7221.00.0040, 7221.00.0045, 7221.00.0060, 7221.00.0075, and 7221.00.0080 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheadings are provided for convenience and customs purposes. The written description remains dispositive.
As a result of the determinations by Commerce and the ITC that revocation of the
The effective date of the continuation of the
This notice also serves as the only reminder to parties subject to an administrative protective order (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(a)(3). Failure to comply is a violation of the APO which may be subject to sanctions.
This five-year sunset review and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On December 20, 2022, the U.S. Court of International Trade (CIT) issued its final judgment in
Applicable December 30, 2022.
Paola Aleman Ordaz, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4031.
On October 2, 2020, Commerce published its
In its final remand redetermination, issued in July 2022, Commerce: (1) valued silver paste using Malaysian import data for HS 7106.92.00 rather than HS 7115.90.1000; (2) under respectful protest, applied partial neutral facts available to value missing factor of production information instead of an adverse inference when selecting facts otherwise available when calculating Risen and Trina's dumping margins; (3) continued to value backsheet using import data from Malaysia HS 3920.62.1000 and EVA using import data from Malaysia HS 3920.10.1900; and (4) revised the weighted-average dumping margins assigned to the separate rate respondents that participated in the litigation.
In its decision in
Because there is now a final court judgment, Commerce is amending its
Because Risen, Trina, Anji DaSol Solar Energy Science & Technology Co., Ltd.; Canadian Solar International Limited, Canadian Solar Manufacturing (Changshu), Inc., Canadian Solar Manufacturing (Luoyang) Inc., CSI Cells Co., Ltd., CSI-GCL Solar Manufacturing (YanCheng) Co., Ltd., and CSI Solar Power (China) Inc.; JA Solar Technology Yangzhou Co., Ltd.; Shanghai JA Solar Technology Co., Ltd.; Shenzhen Sungold Solar Co., Ltd.; Wuxi Tianran Photovoltaic Co. Ltd.; Yingli Energy (China) Company Limited, Baoding Tianwei Yingli New Energy Resources Co., Ltd., Tianjin Yingli New Energy Resources Co., Ltd., Hengshui Yingli New Energy Resources Co., Ltd., Lixian Yingli New Energy Resources Co., Ltd., Baoding Jiasheng Photovoltaic Technology Co., Ltd., Beijing Tianneng Yingli New Energy Resources Co., Ltd., Hainan Yingli New Energy Resources Co., Ltd., and Shenzhen Yingli New Energy Resources Co., Ltd. have a superseding cash deposit rate,
At this time, Commerce remains enjoined, by orders of the CIT, from liquidating entries that: (1) were exported by Risen Energy Co. Ltd., Risen (Wuhai) New Energy Co., Ltd., Zhejiang Twinsel Electronic Technology Co., Ltd., Risen (Luoyang) New Energy Co., Ltd., Jiujiang Shengzhao Xinye Technology Co., Ltd., Jiujiang Shengzhao Xinye Trade Co., Ltd., Ruichang Branch, Risen Energy (HongKong) Co., Ltd., or Risen Energy (Changzhou) Co., Ltd.; Trina Solar Co., Ltd., Trina Solar (Changzhou) Science and Technology Co., Ltd., Yancheng Trina Guoneng Photovoltaic Technology Co., Ltd., Changzhou Trina Solar Yabang Energy Co., Ltd., Turpan Trina Solar Energy Co., Ltd., Hubei Trina Solar Energy Co., Ltd., Trina Solar (Hefei) Science and Technology Co., Ltd., and Changzhou Trina Hezhong Photoelectric Co., Ltd; Anji DaSol Solar Energy Science & Technology Co., Ltd.; Canadian Solar International Limited, Canadian Solar Manufacturing (Changshu), Inc., Canadian Solar Manufacturing (Luoyang) Inc., and CSI Cells Co., Ltd. and imported by Canadian Solar (USA) Inc.;
In the event the CIT's ruling is not appealed, or, if appealed, upheld by a final and conclusive court decision, Commerce intends to instruct CBP to assess antidumping duties on any unliquidated entries described in the preceding paragraph, in accordance with 19 CFR 351.212(b). We will instruct CBP to assess antidumping duties on all appropriate entries covered by the review when the importer-specific
This notice is issued and published in accordance with sections 516A(c) and (e), 751(a)(1), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) has determined that a request for a new shipper review (NSR) of the antidumping duty order on fresh garlic from the People's Republic of China (China) meets the statutory and regulatory requirements for initiation. The period of review (POR) for the NSR is November 1, 2021, through October 31, 2022.
Applicable January 5, 2023.
Charles DeFilippo, 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) 482-3797.
Commerce published the antidumping duty order on fresh garlic on November 16, 1994.
In its submission, Huahui certified that it is the exporter, but not the producer of the subject merchandise subject to this NSR request.
In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2)(iv), Huahui submitted documentation establishing the following: (1) the date on which it first shipped subject merchandise for export to the United States; (2) the volume of its first shipment; and (3) the date of its first sale to an unaffiliated customer in the United States.
Commerce conducted a query of U.S. Customs and Border Protection (CBP) data and confirmed that Huahui's subject merchandise entered the United States for consumption and that liquidation of such entries had been properly suspended for antidumping duties. The CBP data that Commerce examined are consistent with information provided by Huahui in its NSR request. In particular, the CBP data confirms the price and quantity reported by Huahui for the sales that forms the basis of its NSR request.
In accordance with 19 CFR 351.214(g)(1)(i)(A), the POR for an NSR initiated in the month immediately following the anniversary month will be the twelve-month period immediately preceding the anniversary month. Therefore, the POR for this NSR is November 1, 2021, through October 30, 2022.
Pursuant to section 751(a)(2)(B) of the Act and 19 CFR 351.214(b), and based on the information on the record, we find that Huahui's NSR request meets the threshold requirements for initiation of an NSR of its shipment(s) of fresh garlic to the United States.
It is Commerce's practice in cases involving non-market economies to require that a company seeking to establish eligibility for an antidumping duty rate separate from the country-wide rate (
We intend to conduct this NSR in accordance with section 751(a)(2)(B) of the Act.
Interested parties requiring access to proprietary information in this NSR should submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306. This initiation notice is published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Mid-Atlantic and New England Fishery Management Councils (Councils) will hold a public meeting of their joint Northeast Trawl Advisory Panel.
The meeting will be held on Thursday, January 19, 2023, from 9:30 a.m. to 5 p.m. EDT. For agenda details, see
This meeting will be conducted in a hybrid format, with options for both in person and webinar participation. Webinar registration details will be a posted to the calendar at
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The Councils' Northeast Trawl Advisory Panel will meet to review recent developments related to relevant fishery surveys as well as discuss future priorities, research projects, and the draft Operations Manual.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shelley Spedden, (302) 526-5251 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; correction.
NMFS is correcting a notice that appeared in the
This correction is applicable January 5, 2023.
Celeste Stout, NMFS, Office of Protected Resources at
NMFS published a notice in the
The notice incorrectly stated: “NCDMF's monitoring program is largely funded through state appropriations and is supplemented through other sources such as the Atlantic Coastal Cooperative Statistics Program and the National Fish and Wildlife Foundation.” (87 FR 78659, December 22, 2022; 87 FR 78661, December 22, 2022).
While NCDMF's sampling programs are largely funded through state appropriations and are supplemented through other sources such as the Atlantic Coastal Cooperative Statistics Program and the National Fish and Wildlife Foundation, the NCDMF Observer Program is funded completely by the North Carolina Commercial Fishing Resource Fund, where the funds come from an increase in NCDMF's commercial fishing license fees (G.S. 113-173.1). This information is correctly presented in the NCDMF's application, which is available for download and review at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Committee via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This webinar will be held on Thursday, January 19, 2023, at 9 a.m. Webinar registration URL information:
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Committee will receive recommendations from the Recreational Advisory Panel and discuss and develop recommendations to the Council on fishing year 2023 recreational measures for Georges Bank cod, Gulf of Maine cod and Gulf of Maine haddock. They will also possibly revise acceptable biological catch (ABC), along with state and other fisheries sub-components, recommendations for Atlantic halibut for fishing years 2023 through 2025 (this is the only FW65 item to be discussed). The Committee will discuss progress on development of Amendment 23 metrics as well as receive an overview of the Council's groundfish priorities for 2023. Other business will be discussed, as necessary.
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.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
Office of the Secretary (OS), 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 March 6, 2023.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Cleveland Knight, (202) 987-0064.
The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. 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.
There were several data elements/questions on the ED 424 that were required for applicants and were not included on the SF-424. Therefore, ED put these questions that were already cleared as part of the 1894-0007
The questions on this form deal with the following areas: Project Director identifying and contact information; New Potential Grantee or Novice Applicants; Human Subjects Research, and Infrastructure Programs and Build America, Buy America Act Applicability (BABAA). The ED supplemental information form can be used with any of the SF-424 forms in the SF-424 forms family, as applicable.
9:00 a.m., Thursday, January 12, 2023.
You may observe this meeting in person at 1501 Farm Credit Drive, McLean, Virginia 22102-5090, or virtually. If you would like to observe, at least 24 hours in advance, visit
This meeting will be open to the public.
The following matters will be considered:
If you need more information or assistance for accessibility reasons, or have questions, contact Ashley Waldron, Secretary to the Board. Telephone: 703-883-4009. TTY: 703-883-4056.
Federal Deposit Insurance Corporation.
Notice of monetary penalties 2023.
The Federal Deposit Insurance Corporation is providing notice of its maximum civil money penalties as adjusted for inflation.
The adjusted maximum amounts of civil money penalties in this notice are applicable to penalties assessed after January 15, 2023, for conduct occurring on or after November 2, 2015.
Graham N. Rehrig, Counsel, Legal Division, 703-314-3401,
This notice announces changes to the maximum amount of each civil money penalty (CMP) within the Federal Deposit Insurance Corporation's (FDIC) jurisdiction to administer to account for inflation under the Federal Civil Penalties Inflation Adjustment Act of 1990 (1990 Adjustment Act),
Agencies are required to publish their CMPs, adjusted under the multiplier provided by the OMB, by January 15 of the applicable year. Agencies like the FDIC that have codified the statutory formula for making the CMP adjustments may make annual inflation adjustments by providing notice in the
On December 15, 2022, the OMB issued guidance to affected agencies on implementing the required annual adjustment, which guidance included the relevant inflation multiplier.
The following charts provide the inflation-adjusted maximum CMP amounts for use after January 15, 2023—the effective date of the 2023 annual adjustments—under 12 CFR part 308, for conduct occurring on or after November 2, 2015:
Tuesday, January 10, 2023 at 10:00 a.m. and its continuation at the conclusion of the open meeting on January 12, 2023.
1050 First Street NE, Washington, DC and virtual. (This meeting will be a hybrid meeting.)
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109.
Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.
Matters concerning participation in civil actions or proceedings or arbitration.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Office of Government-wide Policy, General Services Administration (GSA).
Meeting notice.
The General Services Administration is providing notice of a public meeting on behalf of the Chief Acquisition Officers Council (CAOC) and the Senior Policy Operating Group's (SPOG) Procurement and Supply Chains Committee to build understanding and awareness about the anti-human trafficking requirements of the Federal Acquisition Regulation (FAR), share information about U.S. government tools and reporting to assist with compliance, and to discuss actions the Federal Government can take to achieve more effective implementation.
The SPOG Procurement and Supply Chains Committee will hold a web-based open public meeting on Tuesday, January 17th, from 1 p.m. to 3 p.m., Eastern Standard Time (EST).
The meeting will be accessible via webcast. Registrants will receive the webcast information before the meeting.
Shenaye Holmes, Senior Advisor-CAO Council, Office of Shared Solutions and Performance Improvement, GSA, phone: 202-213-2922 email:
The National Action Plan to Combat Human Trafficking (available at:
The meeting is open to the public. The meeting will be accessible by webcast. Registration is required for web viewing. To register, go to:
Additionally, using the registration page, registrants will be able to submit questions for the Committee or whether they wish to present during the meeting.
For information on services for individuals with disabilities, or to request accommodation of a disability, please contact Shenaye Holmes at
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice.
GSA is updating the mileage reimbursement rate for privately owned automobiles (POA), airplanes, and motorcycles as required by statute. This information will be available in FTR Bulletin 23-05, which can be found on GSA's website at
For clarification of content, please contact Ms. Cheryl D. McClain-Barnes, Policy Analyst, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-208-4334, or by email at
GSA is required by statute to set the mileage reimbursement rate for privately owned automobiles (POA) as the single standard mileage rate established by the Internal Revenue Service (IRS). The IRS mileage rate for medical or moving purposes is used to determine the POA rate when a Government-furnished automobile is authorized and also represents the privately owned vehicle (POV) standard mileage reimbursement rate for official relocation. Finally, GSA conducts independent reviews of the cost of travel and the operation of privately owned airplanes and motorcycles on an annual basis to determine their corresponding mileage reimbursement rates. These reviews evaluate various factors, such as the cost of fuel, depreciation of the original vehicle cost, maintenance and insurance, state and Federal taxes, and consumer price index data. FTR Bulletin 23-05 establishes and announces the new CY 2023 POV mileage reimbursement rates for official temporary duty and relocation travel. This notice is the only notification to agencies of revisions to the POV mileage rates for official travel and relocation, in addition to the changes posted on GSA's website at
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
General notice.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces an Order requiring negative pre-departure COVID-19 test results or documentation of recovery from COVID-19 for aircraft passengers traveling to the United States from the People's Republic of China or departing from a
This Order will enter into effect for flights departing at or after 12:01 a.m. EST on January 5, 2023.
Candice Swartwood, Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H16-4, Atlanta, GA 30329. Telephone: 404-639-8897; Email:
This Order requires negative pre-departure COVID-19 test results or documentation of recovery from COVID-19 for aircraft passengers traveling to the United States from the People's Republic of China.
Pursuant to 42 CFR 71.20 and 71.31(b), the Order prohibits the boarding of passengers 2 years of age or older on an itinerary that includes the United States
• any aircraft departing from the People's Republic of China, or
• any aircraft departing from a
(a) A negative viral test result for SARS-CoV-2
(b) Documentation of having recovered from COVID-19 in the past 90 days in the form of one of the following (
i. A positive viral test result for SARS-CoV-2 conducted on a specimen collected more than 10 calendar days but fewer than 91 calendar days before the flight's departure; OR
ii. A positive viral test result for SARS-CoV-2 conducted on a specimen collected 10 or fewer calendar days before the flight's departure AND a
Each passenger must retain paper or digital documentation presented to the airline or other aircraft operator reflecting one of the following:
(a) A negative result for the
(b)
Upon request, a passenger, or the passenger's authorized representative, must also produce such documentation to any U.S. Government official or a cooperating state or local public health authority.
This Order constitutes a controlled free pratique to any airline or other aircraft operator with an aircraft boarding passengers subject to the requirements of this Order at an airport in the People's Republic of China or a
A copy of the Order is provided below. A copy of the signed Order and Passenger Attestation can be found at
Pursuant to 42 CFR 71.20 and 71.31(b) and as set forth in greater detail below, this Notice and Order prohibits the boarding of passengers 2 years of age or older on an itinerary that includes the United States
• any aircraft departing from the People's Republic of China, or
• any aircraft departing from a
(c) A negative viral test result for SARS-CoV-2
(d) Documentation of having recovered from COVID-19 in the past 90 days in the form of one of the following (
iii. A positive viral test result for SARS-CoV-2 conducted on a specimen collected more than 10 calendar days but fewer than 91 calendar days before the flight's departure; OR
iv. A positive viral test result for SARS-CoV-2 conducted on a specimen collected 10 or fewer calendar days before the flight's departure AND a signed letter from a licensed healthcare provider or public health official stating that the passenger's COVID-19 symptoms began more than 10 calendar days before the flight's departure.
Each passenger must retain paper or digital documentation presented to the airline or other aircraft operator reflecting one of the following:
(c) A negative result for the
(d)
Upon request, a passenger, or the passenger's authorized representative, must also produce such documentation to any U.S. Government official or a cooperating state or local public health authority.
This Order applies regardless of citizenship or vaccination status. This Order excludes passengers transiting the People's Republic of China (for a period of 24 hours or less) en route to the United States. This Order also excludes passengers who have been in the People's Republic of China for less than 24 hours.
Pursuant to 42 CFR 71.31(b), and as set forth in greater detail below, this Notice and Order constitutes a controlled free pratique to any airline or other aircraft operator with an aircraft boarding passengers subject to the requirements of this Order at an airport in the People's Republic of China or a
• Airline or other aircraft operator must confirm that every passenger subject to the requirements of this Order onboard the aircraft has presented a negative result for a
• Airline or other aircraft operator must verify that every passenger subject to the requirements of this Order onboard the aircraft has attested to one of the following:
○ Having received a negative result for the
○ Having met the criteria for
testing positive for SARS-CoV-2 on a specimen collected more than 10 calendar days but fewer than 91 calendar days before the flight's departure, or
developing COVID-19 symptoms more than 10 full calendar days before the flight's departure if their positive test is dated 10 or fewer calendar days before the flight.
This Notice and Order does not alter the obligation of persons to comply with the applicable requirements of other CDC Orders, including:
• Amended Order Implementing Presidential Proclamation on Advancing the Safe Resumption of Global Travel During the COVID-19 Pandemic (published at 86 FR 61224, April 4, 2022); and
• Other CDC Orders or CDC Directives that may be published relating to preventing the introduction, transmission, and spread of COVID-19 into and throughout the United States.
This Order shall enter into effect for flights departing at or after 12:01 a.m. EST (5:01 a.m. GMT) on January 5, 2023.
This Order shall be interpreted and implemented to achieve the following paramount objectives:
• Preservation of human life;
• Preventing or delaying the introduction, transmission, and spread of any new variants of the virus that causes COVID-19 that may be circulating or emerge in the People's Republic of China;
• Preserving the health and safety of crew members, passengers, airport personnel, and communities; and
• Preserving hospital, healthcare, and emergency response resources and capacity within the United States.
The following categories of individuals and organizations are excepted from the requirements of this Order:
• Crew members of airlines or other aircraft operators if they are on official duty assigned by the airline or aircraft operator that involves operation of the aircraft or positioning of crew not operating the aircraft, provided their assignment is under an air carrier's or operator's occupational health and safety program that follows applicable industry standard protocols for the prevention of COVID-19 consistent with relevant CDC guidance.
• Airlines or other aircraft operators transporting passengers with COVID-19 on flights other than scheduled passenger airline flights pursuant to CDC authorization
• U.S. Federal law enforcement personnel on official orders who are traveling for the purpose of carrying out a law enforcement function, provided they are covered under an occupational health and safety program that takes measures to ensure personnel are not symptomatic or otherwise at increased risk of spreading COVID-19 during travel. Those traveling for training or other business purposes remain subject to the requirements of this Order.
• U.S. military personnel, including civilian employees, dependents, contractors, and other U.S. Government employees when traveling on U.S. military assets (including whole aircraft charter operators) or non-U.S. military flights, if such individuals are under competent military or U.S. Government travel orders and observing applicable U.S. Department of Defense force health protection guidance to prevent the transmission of COVID-19.
• Individuals for whom the issuance of a humanitarian exception is necessary based on both: (1) exigent circumstances where emergency travel is required to preserve health and safety (
COVID-19 is surging in the People's Republic of China.
Although virus variants continue to emerge in countries around the world, the lack of viral genomic sequence data from the People's Republic of China in global databases could delay the identification of new virus variants of concern if they arise. These data are critical to monitor the surge effectively and to allow U.S. public health officials to identify any potential virus variants of concern.
New virus variants have the potential to evade the immune protection acquired in the U.S. population through vaccination and prior illness. The emergence of virus variants that substantially decrease the effectiveness of available vaccines against severe or deadly COVID-19, and decrease the effectiveness of therapeutics and diagnostics, is a primary public health concern for the United States. Additionally, new virus variants could be associated with increases in transmissibility (higher infection rates) or severity (higher rates of hospitalization or death) that have the potential to overwhelm U.S. healthcare systems, especially at a time when influenza and other respiratory viruses are circulating.
Considering the danger to public health posed by potential emerging new virus variants in the People's Republic of China, CDC has determined that additional proactive, preventative measures must be implemented now to protect the U.S. population from potential importation, transmission and spread of new virus variants into the United States. Pre-departure testing and the requirement to show a negative test result decrease the number of infected passengers boarding airplanes and constitute a proactive, risk-based approach. This will help to slow the spread of COVID-19 as we work to identify and understand any potential new virus variants that may emerge. This risk-based testing approach has been addressed in CDC guidance.
CDC acknowledges that pre-departure testing does not eliminate all risk and some positive COVID-19 cases may evade this detection measure. Some tests, including antigen tests, may have lower sensitivity for the virus that causes COVID-19. Some people who test negative within 2 days before their flight may also be exposed to or develop COVID-19 after being tested. Therefore, CDC will implement this testing requirement simultaneously with other mitigation measures, including enhanced education and surveillance strategies.
CDC is expanding the Traveler-based Genomic Surveillance program (TGS), a voluntary program that collects anonymous nasal swabs from arriving international travelers at major U.S. international airports as an early warning system to detect and characterize new and rare variants of the virus that causes COVID-19. The program tests for presence of the virus, and if it is detected, the program sequences the virus's genome to identify any new variants. The program is expanding in order to support increased information about potential virus variants imported from the People's Republic of China.
As part of the Traveler-based Genomic Surveillance program, arriving international travelers on selected flights can volunteer to provide anonymous nasal swabs for testing. The nasal swabs get batched into pools and all positive batches undergo genomic sequencing for the virus, allowing for the quick detection of virus variants from international travelers. This program has proven to overcome gaps in global SARS-CoV-2 variant surveillance that occur as many countries decrease or discontinue testing and sequencing. During the initial weeks of the Omicron surge, TGS detected two Omicron subvariants, BA.2 and BA.3, and reported them to the global database weeks before they were reported elsewhere, demonstrating that the program is able to detect new virus variants early.
Pre-departure testing and the requirement to show a negative test reduces the introduction, transmission, and spread into the United States of virus variants. These measures provide a safer environment for travelers and protect the health of people in the United States, particularly when layered with existing CDC recommendations such as masking during travel, self-monitoring for symptoms, and testing three to five days after arrival from international travel.
The recent surge in COVID-19 cases in the People's Republic of China may result in the emergence of new virus variants that can increase transmissibility or severity or compromise the effectiveness of current medical countermeasures. Because of policies of the People's Republic of China relating to COVID-19, the population has not developed immune protection and is more susceptible to infection when compared with other countries. Travelers are an important population to consider when tracking new and emerging infectious diseases because they move from place to place quickly and can contract and spread infectious diseases. Pre-departure testing and the requirement to show a negative test helps prevent infected travelers from boarding flights to the United States and slows the introduction, transmission, and spread of virus variants into the United States. The introduction of infected travelers and potential emergence of virus variants of concern are of particular concern at this time, when the United States' healthcare system is already facing surges in other respiratory viruses.
Based on the lack of viral genomic sequence data from the People's Republic of China, this action is necessary imminently to allow U.S. public health officials the critical time needed to monitor the unprecedented surge of COVID-19 in the People's Republic of China effectively and to identify any potential variants of concern. CDC will continue to monitor the situation and be prepared to quickly adjust its approach as necessary to protect the public's health.
Due to the current volume of passengers from the People's Republic of China transiting through Incheon International Airport, Toronto Pearson International Airport, and Vancouver International Airport on their way to the United States, I have determined that prompt action is needed with respect to travelers departing from these airports if they have been in the People's Republic of China in the last 10 days. CDC, in coordination with other Federal agencies, will continue to monitor travel patterns between the People's Republic of China and the United States and adjust its approach as needed.
This Order is not a rule within the meaning of the Administrative Procedure Act (“APA”) but rather is an emergency action taken under the existing authority of 42 U.S.C. 264(a) and 42 CFR 71.20 and 71.31(b), which were promulgated in accordance with the APA after full notice-and-comment rulemaking and a delay in effective date. In the event that this Order qualifies as a new rule under the APA, notice and comment and a delay in effective date are not required because there is good cause to dispense with prior public notice and comment and a delay in effective date.
Considering the rapid surge in cases in the People's Republic of China, it would be impracticable and contrary to the public's health, and by extension the public's interest, to delay the issuance and effective date of this Order. Further delay could increase risk of transmission and importation of undetected emerging virus variants through passengers. New virus variants could be associated with increases in transmissibility (higher case rates), severity (higher rates of hospitalization or death), and have the potential to overwhelm U.S. healthcare systems, especially at a time when influenza and other respiratory viruses are circulating.
Similarly, the Office of Information and Regulatory Affairs has determined that if this Order were a rule, it would be a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (the Congressional Review Act), 5 U.S.C. 804(2), but there would not be a delay in its effective date as the agency has determined that there would be good cause to make the requirements herein effective immediately under the APA, 5 U.S.C. 808(2).
This Order is also an economically significant regulatory action under Executive Order 12866 and has therefore been reviewed by the Office of Information and Regulatory Affairs of the Office of Management and Budget.
Pursuant to 5 U.S.C. 553(b)(B), and for the reasons stated above, I hereby conclude that good cause exists to dispense with notice-and-comment rulemaking because engaging in such rulemaking is impractical, would endanger the public health, and thus, be contrary to the public interest. For the same reasons, I have determined, consistent with 5 U.S.C. 553(d)(3), that there is good cause to make this Order effective for flights departing at or after 12:01 a.m. EST (5:01 a.m. GMT) on January 5, 2023.
If any provision of this Order, or the application of any provision to any carriers, persons, or circumstances, shall be held invalid, I intend that the remainder of the provisions, or the application of such provisions to any carriers, persons, or circumstances other than those to which it is held invalid, shall remain valid and in effect. Although the application of all of this Order's provisions uniformly across all carriers, persons, and circumstances will maximize the Order's protection of health and safety, the various provisions and applications of this Order operate independently and independently further the purposes of this Order. Thus, in the event of a stay or invalidation of any provision of the Order, or of the Order as it applies to any carrier, person, or circumstances, my intent is that the remainder of the Order remain in effect.
For the reasons outlined above, I hereby determine that passengers subject to the requirements of this Order are at risk of transmitting new SARS-CoV-2 variants that may be circulating or emerge in the People's Republic of China. Accordingly, requiring these passengers to present either a negative COVID-19 test result or recovery from COVID-19 in the past 90 days is necessary to reduce the risk of introduction, transmission and spread of new SARS-CoV-2 variants, and to protect the health of fellow passengers, aircraft crew, and U.S. communities. This Order shall remain effective until I determine that based on specific public health or other considerations that continuation of this Order is no longer necessary to prevent the introduction, transmission, and spread of new SARS-CoV-2 variants into the United States. Upon determining that continuation of this Order is no longer necessary to prevent the introduction, transmission, and spread of new SARS-CoV-2 variants into the United States, I will publish a notice in the
Any airline or other aircraft operator boarding passengers subject to the requirements of this Order shall:
A. Identify which passengers are subject to the requirements of this Order and confirm that each such passenger, prior to boarding the aircraft, has presented paper or digital documentation reflecting a
(1) Requirements for a
a. Documentation of a negative SARS-CoV-2 viral test result from a specimen collected no more than 2 calendar days before the flight's departure. The negative SARS-CoV-2 viral test result must include:
i. personal identifiers (
ii. a specimen collection date indicating that the specimen was collected no more than 2 calendar days before the flight's departure;
iii. the type of viral test indicating it is a NAAT or antigen test;
iv. a test result that states “NEGATIVE,” “SARS-CoV-2 RNA NOT DETECTED,” “SARS-CoV-2 ANTIGEN NOT DETECTED,” or “COVID-19 NOT DETECTED,” or other indication that SARS-CoV-2 was not detected in the individual's specimen. A test marked “invalid” is not acceptable; and
v. information about the entity issuing the result (
(2) Requirements for
a. Documentation of a positive SARS-CoV-2 viral test result from a specimen collected more than 10 calendar days but fewer than 91 calendar days preceding the flight's departure.
i. personal identifiers (
ii. a specimen collection date indicating that the specimen was collected more than 10 calendar days but fewer than 91 calendar days before the flight's departure;
iii. information that the test performed was a viral test indicating it is a NAAT or antigen test;
iv. a test result that states “POSITIVE,” “SARS-CoV-2 RNA DETECTED,” “SARS-CoV-2 ANTIGEN DETECTED,” or “COVID-19 DETECTED,” or other indication that
v. information about the entity issuing the result (
b. Documentation of a positive SARS-CoV-2 viral test result from a specimen collected 10 or fewer calendar days before the flight's departure AND a signed letter from a licensed healthcare provider or a public health official stating that the passenger's COVID-19 symptoms began more than 10 calendar days before the flight's departure. The letter must list the date the person's symptoms started; have personal identifiers (
i. personal identifiers (
ii. information that the test performed was a viral test indicating it is a NAAT or antigen test;
iii. a test result that states “POSITIVE,” “SARS-CoV-2 RNA DETECTED,” “SARS-CoV-2 ANTIGEN DETECTED,” or “COVID-19 DETECTED,” or other indication that SARS-CoV-2 was detected in the individual's specimen. A test marked “invalid” is not acceptable; and
iv. information about the entity issuing the result (
B. Confirm that each passenger has attested to having received a negative result for a
C. Not board any passenger without confirming the documentation as set forth in this Order.
Any airline or other aircraft operator that fails to comply with section 1, “Requirements for Airlines & Other Aircraft Operators,” may be subject to criminal penalties under,
Any aircraft passenger subject to the requirements of this Order shall—
A. Present paper or digital documentation reflecting one of the following:
(1) A negative
(2)
a. a positive SARS-CoV-2 viral test result conducted on a specimen collected more than 10 calendar days but fewer than 91 calendar days preceding the passenger's scheduled flight to the United States; OR
b. documentation of a positive SARS-CoV-2 viral test result from a specimen collected 10 or fewer calendar days before the flight's departure AND a signed letter from a licensed healthcare provider or a public health official stating that the passenger's COVID-19 symptoms began more than 10 days before the flight's departure.
B. Provide the attestation to the airline or other aircraft operator, of:
(1) having received a negative result for the
(2) having met the requirements for
The attestation is attached to this order as Attachment A. A parent or other authorized individual may present the required documentation on behalf of a passenger 2-17 years of age. An authorized individual may act on behalf of any passenger who is unable to act on their own behalf (
C. Retain a copy of the applicable documentation listed in part A of this section and produce such documentation upon request to any U.S. Government official or a cooperating state or local public health authority after arrival into the United States.
Any passenger who fails to comply with the requirements of section 2, “Requirements for Aircraft Passengers,” may be subject to criminal penalties under,
This Order shall be enforceable through the provisions of 18 U.S.C. 3559, 3571; 42 U.S.C. 243, 268, 271; and 42 CFR 71.2. As the COVID-19 pandemic continues to rapidly evolve and more scientific data becomes available regarding potential emerging virus variants in the People's Republic of China, CDC may exercise its enforcement discretion to adjust the scope of accepted pre-departure testing requirements to allow passengers and airline and aircraft operators greater flexibility regarding the requirements of this Order or to align with current CDC guidance. Such exercises of enforcement discretion will be announced on CDC's website and the Order will be amended as soon as practicable through an updated publication in the
This Order shall enter into effect for flights departing at or after 12:01 a.m. EST (5:01 a.m. GMT) on January 5, 2023, and will remain in effect unless modified or rescinded based on specific public health or other considerations.
The authority for this Order is Section 361 of the Public Health Service Act (42 U.S.C. 264) and 42 CFR 71.20 & 71.31(b).
This passenger disclosure and attestation fulfills the requirements of U.S. Centers for Disease Control and Prevention (CDC) Order:
As required by United States Federal law, all airlines or other aircraft
As required by the Order, all airlines and other aircraft operators must provide this disclosure to all air passengers who are ages 2 years and older
(1) an aircraft in the People's Republic of China, or
(2) an aircraft at a
This requirement does not apply to passengers transiting through an airport in the People's Republic of China en route from another country to the United States. It also does not apply to passengers who have been in the People's Republic of China for less than 24 hours.
The airline must identify which passengers are subject to the requirements of this Order and confirm that each such passenger, prior to boarding the aircraft, has presented paper or digital documentation reflecting:
A. A negative result for a COVID-19 viral test taken no more than 2 days before the departure of the flight from an airport in the People's Republic of China or a Designated Airport; or
B.
A positive viral test result for COVID-19 conducted on a sample collected more than 10 calendar days but fewer than 91 calendar days before the departure of the flight from an airport in the People's Republic of China or a
A positive viral test result for COVID-19 conducted on a sample taken 10 or fewer calendar days before the flight AND a signed letter from a licensed healthcare provider or public health official stating that the passenger's symptoms began more than 10 calendar days before the departure of the flight from an airport in the People's Republic of China or a
C. A
The information provided below must be accurate and complete to the best of the person's knowledge. Under United States Federal law, the attestation must be completed for each air passenger 2 years of age or older who has an itinerary that includes the United States and is boarding an aircraft in the People's Republic of China; or is boarding an aircraft at a
One attestation form must be filled out for each air passenger 2 years of age or older with an itinerary that includes the United States prior to boarding
(1) an aircraft in the People's Republic of China; or
(2) an aircraft at a
Public reporting burden of this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. 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. Comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, may be submitted to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA 0920-XXXX.
The air passenger or the person acting on behalf of the air passenger as a legal representative, such as a parent or guardian, must check A, B, or C and sign the attestation.
I, ____ am attesting on
or
The U.S. Centers for Disease Control and Prevention (CDC) requires airlines and other aircraft operators to collect this information pursuant to 42 CFR 71.20 and 71.31(b), as authorized by 42 U.S.C. 264. Providing this information is mandatory for all passengers 2 years and older boarding an aircraft into the United States from the People's Republic of China, or from
Failure to provide this information may prevent you from boarding the plane. Additionally, passengers will be required to attest to providing complete and accurate information, and failure to do so may lead to other consequences, including criminal penalties. CDC will use this information to help prevent the introduction, transmission, and spread of communicable diseases.
The Privacy Act of 1974, 5 U.S.C. 552a, governs the collection and use of this information about citizens of the United States and aliens lawfully admitted for permanent residence. The information maintained by CDC will be covered by CDC's System of Records No. 09-20-0171, Quarantine- and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification under 42 CFR parts 70 and 71. See 72 FR 70867 (Dec. 13, 2007), as amended by 76 FR 4485 (Jan. 25, 2011) and 83 FR 6591 (Feb. 14, 2018). CDC will only disclose information from the system outside the CDC and the U.S. Department of Health and Human Services as the Privacy Act permits, including in accordance with the routine uses published for this system in the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Format and Content of a REMS Document.” This final guidance describes the format for a proposed risk evaluation and mitigation strategy (REMS) document. This format was created based on extensive stakeholder feedback. This guidance finalizes the revised draft guidance of the same title issued on October 12, 2017, and announces the availability of the technical specifications document entitled “REMS Document Technical Conformance Guide.”
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Suzanne Robottom, Center for Drug Evaluation and Research, Food and Drug Administration,10903 New Hampshire Ave, Bldg. 22, Rm. 4475, Silver Spring, MD 20993-0002, 301-796-3554, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a guidance for industry entitled “Format and Content of a REMS Document.” Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) authorizes FDA to require a REMS for certain drugs if FDA determines that a REMS is necessary to ensure that the benefits of the drug outweigh its risks (see section 505-1(a) of the FD&C Act). A REMS is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks (see section 505-1(e) of the FD&C Act). The REMS document should include concise information that describes the goals and requirements of a REMS as they relate to the elements described under the FD&C Act.
In the
This guidance finalizes the revised draft guidance entitled “Format and Content of a REMS Document” issued on October 12, 2017. FDA considered comments received on the revised draft guidance as the guidance was finalized. Changes from the revised draft guidance to the final guidance include: revising the REMS document to add and clarify requirements participants, including the applicants, must complete to comply with the REMS, adding a reference to a new authority to require certain packaging and safe disposal technologies for drugs that pose a serious risk of abuse or overdose, adding a new section to list the statutory elements of the REMS, adding a prompt to identify the risk addressed by the REMS, and relocating the information contained in the appendix of the guidance (
The guidance, along with the new technical specifications document, can be used for drafting a REMS document for a single product and shared system REMS and includes recommendations for drafting a Bifurcated REMS document.
The recommendations in this guidance and the associated technical specifications document are intended to help ensure that REMS documents are clear; understandable to stakeholders; and to the extent possible, consistent in content and format, as well as support submission of a REMS document in Structured Product Labeling format, which is required starting December 28, 2022.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the format and content of a REMS document. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 pertaining to the submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to NDAs and ANDAs have been approved under 0910-0001. The collections of information in 21 CFR part 601 pertaining to biologics license applications (BLAs) and supplements to BLAs have been approved under OMB control number 0910-0338. The collections of information pertaining to Medication Guides for prescription drug products have been approved under OMB control number 0910-0393.
Persons with access to the internet may obtain the guidance at
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
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Bethany Miller, HRSA, Maternal and Child Health Bureau, telephone: (301) 945-5156, email:
Under the Patient Protection and Affordable Care Act, Public Law 111-148, the preventive care and screenings set forth in HRSA-supported guidelines are required to be covered without cost-sharing by certain group health plans and health insurance issuers. The Department adopted the Bright Futures Periodicity Schedule as a HRSA-supported guideline for infants, children, and adolescents under section 2713 of the Public Health Service Act. See 75 FR 41726, 41740 (July 19, 2010). To develop recommendations for HRSA's consideration, the Bright Futures Program convenes a panel of pediatric primary care experts to conduct rigorous reviews of current scientific evidence, solicit and consider public input, and make recommendations to HRSA regarding screenings and assessments recommended at each well-child visit from infancy through adolescence. HRSA then determines whether to support, in whole or in part, the recommended updates. The schedule of preventive care and screenings for infants, children, and adolescents is reflected in the Bright Futures Periodicity Schedule. This work is supported through the Bright Futures Program via cooperative agreement with the American Academy of Pediatrics.
The Bright Futures Program convenes a panel of pediatric primary care experts that examines the evidence to develop new (and update existing) recommendations for pediatric preventive services. The Bright Futures Program also disseminates final HRSA-supported recommendations through the annual publication of the updated Bright Futures Periodicity Schedule, with associated resources for practitioners and families.
The Bright Futures Program bases its recommended updates to the Guidelines on review and synthesis of existing clinical guidelines and new scientific evidence. Additionally, HRSA requires that the Bright Futures Program incorporate processes to assure opportunity for public comment in the development of the updated Bright Futures Periodicity Schedule.
The Bright Futures Program proposed and HRSA has accepted recommended updates to the Bright Futures Periodicity Schedule relating to increasing the upper age limit for Screening for HIV as detailed below.
In the current Bright Futures Periodicity Schedule, the age range recommended for adolescent universal screening for HIV is between the 15-year visit and 18-year visit. The Bright Futures Program proposed and HRSA has accepted an update that would expand the recommended age range for adolescent universal screening for HIV to between the 15-year visit and 21-year visit.
In the Bright Futures Periodicity Schedule, a “dot” with an “arrow” indicates a “range during which a service may be provided.” The previous guideline and updated guideline on HIV screening is reflected in the chart below:
All such screenings (universal and risk-based) within this age range are within the scope of the guideline. The update also includes an accompanying footnote to provide updated information about more frequent screening for youth assessed as at high risk of HIV infection. The full footnote reads: “Screen adolescents for HIV at least once between the ages of 15 and 21 making every effort to preserve confidentiality of the adolescent, as per “Human
Early detection of an infection with HIV in adolescents and young adults can lead to improved health outcomes and reduce the further spread of HIV by individuals who are not yet aware they are infected. Universal screening is a type of screening that a provider may recommend without first identifying a specific risk factor or symptom. Given the sustained high numbers of people living with HIV in the United States; documented missed opportunities for HIV testing; advances in HIV diagnostics, treatment, and prevention; and age stratified epidemiological data around HIV incidence and HIV risk related behaviors, the range for universal screening is being extended to the 21-year visit.
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After consideration of public comment, the Bright Futures Program submitted recommended updates for HIV screening to HRSA for consideration, as detailed above. On December 30, 2022, the HRSA Administrator accepted the Bright Futures Program recommendations and, as such, updated the guidelines. Non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage must cover without cost-sharing the services and screenings listed as the HRSA-supported preventive services guidelines for infants, children, and adolescents for plan years (in the individual market, policy years) that begin one year after this date. Thus, for most plans, this update will take effect for purposes of the Section 2713 coverage requirement in 2024. Additional information regarding the Bright Futures Program can be accessed at the following link:
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this ICR must be received no later than February 6, 2023.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
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The 2011 HHS race and ethnicity categories maintains alignment with the 1997 OMB
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UDS+ Patent Level Reporting leverages a methodological shift in the process by which health centers submit their annual UDS report, while maintaining historic UDS measures. High-quality accessible data are critical to strategically meeting the needs of patients and identifying opportunities for clinical process improvement. The growth in health information technology coupled with the increased adoption of electronic health records has transformed patient care delivery and underscored the need for secure and rapid exchange of health data between disparate systems. Health Level Seven International
This electronic reporting mechanism will reduce reliance on manual data entry to populate the annual UDS report, in turn yielding a reduction in reporting effort burden, and will greatly
HRSA specifically requests comments on: (1) the necessity and feasibility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
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Kimberly Sherman, HRSA, Maternal and Child Health Bureau, telephone: (301) 443-8283, email:
Under the Patient Protection and Affordable Care Act, Public Law 111-148, the preventive care and screenings set forth in the Guidelines are required to be covered without cost-sharing by certain group health plans and health insurance issuers. HRSA established the Guidelines in 2011 based on expert recommendations by the Institute of Medicine, now known as the National Academy of Medicine, developed under a contract with the Department of Health and Human Services. Since 2016, HRSA has funded cooperative agreements with the American College of Obstetricians and Gynecologists (ACOG) for the Women's Preventive Services Initiative (WPSI), to convene a coalition representing clinicians, academics, and consumer-focused health professional organizations to
WPSI incudes an Advisory Panel and two expert committees, the Multidisciplinary Steering Committee and the Dissemination and Implementation Steering Committee, which are comprised of a broad coalition of organizational representatives who are experts in disease prevention and women's health issues. With oversight by the Advisory Panel, and with input from the Multidisciplinary Steering Committee, WPSI examines the evidence to develop new (and update existing) recommendations for women's preventive services. WPSI's Dissemination and Implementation Steering Committee takes HRSA-approved recommendations and disseminates them through the development of implementation tools and resources for both patients and practitioners.
WPSI bases its recommended updates to the Guidelines on review and synthesis of existing clinical guidelines and new scientific evidence, following the National Academy of Medicine standards for establishing foundations for and rating strengths of recommendations, articulation of recommendations, and external reviews. Additionally, HRSA requires that WPSI incorporate processes to assure opportunity for public comment, including participation by patients and consumers, in the development of the updated Guidelines.
WPSI proposed and HRSA has accepted recommended updates to the Guidelines relating to Screening for Diabetes in Pregnancy and Screening for Diabetes after Pregnancy as detailed below:
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The current “Screening for Gestational Diabetes Mellitus” title is now revised to read “Screening for Diabetes in Pregnancy” and the clinical recommendation is now revised to state: “The Women's Preventive Services Initiative recommends screening pregnant women for gestational diabetes mellitus after 24 weeks of gestation (preferably between 24 and 28 weeks of gestation) to prevent adverse birth outcomes. WPSI recommends screening pregnant women with risk factors for type 2 diabetes or GDM before 24 weeks of gestation—ideally at the first prenatal visit.”
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The current “Screening for Diabetes Mellitus after Pregnancy” title is now revised to read “Screening for Diabetes after Pregnancy” and the clinical recommendation is now revised to state: “The WPSI recommends screening for type 2 diabetes in women with a history of gestational diabetes mellitus (GDM) who are not currently pregnant and who have not previously been diagnosed with type 2 diabetes. Initial testing should ideally occur within the first year postpartum and can be conducted as early as 4-6 weeks postpartum. Women who were not screened in the first year postpartum or those with a negative initial postpartum screening test result should be screened at least every 3 years for a minimum of 10 years after pregnancy. For those with a positive screening test result in the early postpartum period, testing should be repeated at least 6 months postpartum to confirm the diagnosis of diabetes regardless of the type of initial test (
WPSI recommended three updates to the Guideline on Screening for Gestational Diabetes Mellitus. The first change is a revision to the title of the Guideline from “Screening for Gestational Diabetes Mellitus” to “Screening for Diabetes in Pregnancy.” This change to the title was made for consistency with the clinical recommendation, which includes screening for gestational diabetes and screening for preexisting diabetes, as the previous title described a more limited scope in screening. The second update recommended by WPSI is to change language in the second sentence of the recommendation from “diabetes mellitus” to “type 2 diabetes or GDM.” This change reflects that “diabetes mellitus” is commonly described as type 2 diabetes. Third, WPSI modified the recommendation by relocating the information on specific types of screening to the Implementation Considerations section of the Guideline. The existing Guideline recommends the 2-step approach, because of its high sensitivity and specificity. In its recommended update, WPSI continues to recommend the 2-step approach, but has relocated it to the Implementation Considerations section, and added the 1-step approach to the list of screening modalities in the Implementation Considerations section, because both approaches are acceptable screening tests based on studies described in the updated 2021 United States Preventive Services Task Force evidence review. Both the 1-step and 2-step screening modalities are within the scope of this Guideline.
WPSI also recommended five updates to the Guideline on Screening for Diabetes Mellitus After Pregnancy. The first change is a revision to the title of the Guideline, from “Screening for Diabetes Mellitus After Pregnancy” to “Screening for Diabetes After Pregnancy.” This change was made because “diabetes mellitus” is more commonly described as diabetes. Second, WPSI recommended removing the reference to Table 1, “Preferred Testing Strategy Based on Postpartum Timeframe” based upon feedback from the clinical community, noting that the table might be confusing and could be simplified in written format, and recommended including this information in narrative form. Third, WPSI recommended screening for “women who are not screened in the first year postpartum” and “women with a positive screening test result in early postpartum.” This recommendation was added to ensure screening for women who were not screened postpartum for various reasons (
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After consideration of public comment, WPSI submitted the recommended updates for (1) Screening for Diabetes in Pregnancy and (2) Screening for Diabetes after Pregnancy as detailed above. On December 30, 2022, the HRSA Administrator accepted WPSI's recommendations and, as such, updated the Women's Preventive Services Guidelines. Non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage must cover without cost-sharing the services and screenings listed on the updated Women's Preventive Services Guidelines for plan years (in the individual market, policy years) that begin 1 year after this date. Thus, for most plans, this update will take effect for purposes of the section 2713 coverage requirement in 2024. Additional information regarding the Women's Preventive Services Guidelines can be accessed at the following link:
U.S. Coast Guard, Department of Homeland Security.
Notice of Federal advisory committee meeting.
The Great Lakes Pilotage Advisory Committee (Committee) will meet in Covington, Louisiana, to discuss matters relating to Great Lakes Pilotage, including review of proposed Great Lakes Pilotage regulations and policies. The meeting will be open to the public.
The meeting will be held at the Covington Firehouse Event Center, 432 N Theard Street, Covington, LA, 70433;
The Great Lakes Pilotage Advisory Committee is committed to ensuring all participants have equal access regardless of disability status. If you require reasonable accommodation due to a disability to fully participate, please email Mr. Francis Levesque at
Mr. Frank Levesque, Alternate Designated Federal Officer of the Great Lakes Pilotage Advisory Committee, telephone (571) 308-4941 or email
Notice of this meeting is in compliance with the
A copy of all meeting documentation will be available at
Public comments or questions will be taken throughout the meeting as the Committee discusses the issues and prior to deliberations and voting. There will also be a public comment period at the end of the meeting. Speakers are requested to limit their comments to 5 minutes. Contact the individual listed in the
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA), Bureau of Indian Education (BIE), and Office of the Assistant Secretary—Indian Affairs (AS-IA) are proposing to renew ten (10) information collections. Office of Management and Budget (OMB) Control Number 1076-0017, 1076-0100, 1076-0172, 1076-0176, 1076-0177, 1076-0179, 1076-0187, 1076-0188, 1076-0195, and 1076-0196.
Interested persons are invited to submit comments on or before March 6, 2023.
To submit a comment, please visit
Steven Mullen, Information Collection Clearance Officer, by email at
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are especially interested in public comment addressing the following:
(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of our estimate of the burden for the collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve the ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for these ICR actions is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
United States International Trade Commission.
60-Day notice and request for comment.
This notice announces the intention of the U.S. International Trade Commission (Commission) to request a three-year extension, under the Paperwork Reduction Act of 1995 (the Act), of the current generic survey clearance that the Office of Management and Budget (OMB) previously approved. The Commission uses this clearance to issue information collections for investigations that it is required to conduct under the Tariff Act of 1930, the Trade Act of 1974, and other trade-remedy statutes that require or authorize the Commission to make findings or determinations. The current generic survey clearance is assigned OMB Control No. 3117-0016; it will expire on June 30, 2023. The Commission requests comments concerning the proposed information collections under section 3506(c)(2)(A) of the Act; this notice describes such comments in greater detail in the supplementary information section below.
To assure that the Commission will consider your comments, it must receive them no later than 60 days after publication of this notice in the
Submit signed comments to Katherine Hiner, Acting Secretary to the Commission, (
You may obtain copies of the proposed information collection and supporting documentation from Stamen Borisson, Office of Investigations,
The Commission solicits comments as to: (1) whether the proposed information collection is necessary for the proper performance of the Commission's functions; (2) the accuracy of the Commission's estimate of the burden of the proposed information collection; (3) the quality, utility, clarity, and design of the information to be collected; and (4) minimization of the burden of the proposed information collection on those who are to respond (including through the use of appropriate automation, electronic filing, or other forms of information technology). To the extent appropriate, please cite to specific experiences that your firm has had with other governmental surveys and data collections.
The Commission utilizes, or may utilize, the information requested in questionnaires and five-year review institution notices issued under the generic survey clearance in the following statutory investigation types: antidumping duty, countervailing duty, safeguards, other import competition, market disruption, interference with programs of the U.S. Department of Agriculture, and cross-border long-haul trucking. This clearance also covers questionnaires needed for new types of trade-remedy investigations when directed in new legislation, such as rules of origin investigations or other matters in which the Commission is directed to make a determination or findings. The vast majority of information requests issued by the Commission under the existing generic clearance authority relate to antidumping and countervailing duty investigations, or reviews of orders previously issued in such investigations. The Commission's generic survey clearance to issue questionnaires does not apply to fact-finding investigations or technical assistance conducted under section 332 of the Trade Act of 1974.
The information provided by firms in response to the questionnaires under this authority provides information that the Commission uses in making its findings and determinations. Commission staff consolidates submitted information and provides it to the Commission primarily in the form of data tables, figures, and analysis within a written report. In addition, in the majority of its investigations, the Commission releases completed questionnaires returned by industry participants to representatives of parties to its investigations under an administrative protective order, the terms of which safeguard the confidentiality of any business proprietary or business confidential information. Representatives of interested parties also receive a confidential version of Commission reports under that same administrative protective order. Included in the proposed generic clearance is the administrative protective order
The Commission sends questionnaires for specific investigations to all identified domestic producers of the product(s) in question subject to the Commission proceeding. The Commission also sends importer and purchaser questionnaires to all substantial U.S. importers and purchasers of the product(s). Further, the Commission sends questionnaires to all foreign manufacturers of the product(s) in question that are represented by counsel, and, in addition, it attempts to contact any other foreign manufacturers, especially if they export the product(s) in question to the United States. Firms receiving questionnaires include businesses, farms, and other for-profit institutions; responses by domestic firms are mandatory. The Commission publishes institution notices for the five-year reviews in the
As it relates to import injury questionnaires, the content of each questionnaire will differ based on the needs of a particular investigation; questionnaires are based on long-established, generic formats, that align the data being gathered to the specific points of analysis that the statutes direct the Commission to analyze. Producer questionnaires generally consist of the following four parts: (part I) general questions relating to the organization and activities of the firm; (part II) data on capacity, production, inventories, employment, and the quantity and value of the firm's shipments and purchases from various sources; (part III) financial data, including income-and-loss data on the product in question, data on asset valuation, research and development expenses, and capital expenditures; and (part IV) pricing and market factors. Questionnaires may, on occasion, also contain additional parts depending on the facts of the case and the arguments raised by interested parties, the most frequent of which relate to information to assess proposed alternative definitions of the domestic like product.
Importer questionnaires generally consist of three parts: (part I) general questions relating to the organization and activities of the firm; (part II) data on the firm's imports and the shipment and inventories of its imports; and (part III) pricing and market factors similar to that requested in the domestic producer questionnaire. Purchaser questionnaires generally consist of four parts: (part I) general questions relating to the organization and activities of the firm; (part II) data concerning the purchases of the product by the firm and the names of the firm's vendors; (part III) market characteristics and purchasing practices; and (part IV) comparisons between imported and U.S.-produced product. The Commission may send an abbreviated purchaser questionnaire: (1) in a preliminary phase investigation, consisting of two parts: (part I) data concerning the purchases of the product by the firm; and (part II) questions regarding purchasing practices; or (2) in an adequacy phase of a review investigation, consisting of one part: (part I) general questions regarding the industry. Foreign producer questionnaires generally consist of: (part I) general questions relating to the organization and activities of the firm; (part II) data concerning the firm's manufacturing operations; and may include (part III) market factors. The notices of institution for the five-year reviews include 11 specific requests for information that firms are to provide if their response is to be considered by the Commission.
The Commission estimates that information collections issued under the requested generic clearance will impose an average annual burden of 409,050 hours on 12,935 respondents (
The Commission periodically reviews its investigative processes, including data collection, to reduce the information burden. Questionnaires clearly state that reasonable estimates are acceptable for certain items. The questionnaires are designed in part with check-in type formats to simplify the response. The reporting burden is reduced by limiting data to a terminal year when a time series is not required. Moreover, the reporting burden for smaller firms is reduced in that the sections of the questionnaire that are applicable to their operations are typically more limited and, when pertinent, there are fewer requested data points. The Commission will not accept requests by parties to expand the data collection or add items to the questionnaire for specific investigations if it believes that such requests will increase the response burden without substantially adding to the investigative record. Respondents submit the information provided in response to the Commission's notices of institution for the five-year reviews electronically to the Commission's Electronic Data Information System (EDIS) and Electronic Docket. In addition, the Commission has reduced the information burden by streamlining the questionnaires. For example, the Commission removed redundant fields, added auto-calculated reconciliation fields, enabled population of whole data tables, and reduced the number of years for which data is collected in certain five-year reviews. In addition, the Commission ceased collecting nonsubject pricing data in preliminary proceedings.
No record keeping burden is known to result from the proposed collection of information.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Katherine M. Hiner, Acting 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 accessed on the Commission's Electronic Document Information System (EDIS) 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 Viking Therapeutics, Inc. on December 29, 2022. 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 regarding certain selective thyroid hormone receptor-beta agonists, processes for manufacturing or relating to same, and products containing same. The complainant names as respondents: Ascletis Pharma Inc. of China; Ascletis Pharmaceuticals Co. Ltd. of China; Ascletis Bioscience Co., Ltd. of China; Gannex Pharma Co., Ltd. of China; Jinzi Jason Wu of Seattle, WA. The complainant requests that the Commission issue a permanent exclusion order, a cease and desist order, and impose a bond upon respondent's alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public 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. 3662”) 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.
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before February 6, 2023.
You may submit comments identified by Docket No. MSHA-2022-0070 by any of the following methods:
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2.
3.
4.
S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.
The petitioner states that:
(a) They are seeking an alternative to the 3M Airstream helmet to provide miners with respirable protection against coal mine dust, a protection that can provide long-term health benefits.
(b) The 3M Airstream helmet has been used in mines for over 40 years. 3M faced component disruptions for the Airstream product, causing 3M to discontinue, globally, the Airstream on June 1, 2020. The ability to order an Airstream system and components ended in February 2020, with components available through June 2020. Currently, there are no replacement powered air purifying respirators (PAPRs) that meet the MSHA standard for permissibility. PAPRs provide a constant flow of filtered air and offer respiratory protection and comfort in hot working environments.
(c) The CleanSpace EX Powered Respirator (CleanSpace EX) is UL certified to the ANSI/UL 60079-11 standard and can be used in hazardous locations because it meets the intrinsic safety protection level. It is acceptable in other jurisdictions for use in mines with the potential for methane accumulation. The product is not MSHA approved, and the manufacturer is not pursuing approval. The standards for the approval of these respirators are an accepted alternative to MSHA's standards and provide the same level of protection.
(d) The CleanSpace EX uses a lithium-ion polymer battery that is neither accessible nor removable. The lithium-ion polymer battery and motor/blower assembly are both contained within the sealed power pack assembly. It charges as a complete unit.
(e) The CleanSpace EX can be easily disassembled and cleaned.
(f) The CleanSpace EX is designed to utilize either a half or full facemask and NIOSH-approved particulate filters. It does not impair vision nor communication. The CleanSpace EX provides more comfort, as it allows the miner to simultaneously wear the issued hardhat with a headlamp. The PAPR's filter housing and fan assembly are above the shoulders, reducing ergonomic restrictions, freeing the miner from wearing the fan and filter unit around the waist, and eliminating hose attachments to the unit, which could create added hazards.
The petitioner proposes the following alternative method:
(a) Affected mine employees shall be trained in the proper use and maintenance of the CleanSpace EX in accordance with the established manufacturer guidelines. Mine employees shall also be trained to inspect the unit before each use to determine if there is any damage or defects to the unit that would negatively impact intrinsic safety. This inspection shall include all associated wiring and connections and shall take place prior to the equipment being taken underground.
(b) If it is determined that there is damage that may negatively impact the intrinsic safety, the PAPR shall be immediately removed from service.
(c) The CleanSpace EX user shall conduct daily examinations of the filter and replace as needed.
(d) When fitting a new filter on the CleanSpace EX, the Blocked Filter Alarm shall be tested by the user before the PAPR is put back into service.
(e) CleanSpace EX units shall be charged outby the last open crosscut and shall utilize the manufacturer approved battery charger. CleanSpace EX charging stations located underground shall be enclosed in a properly constructed steel box designed for such purpose.
(f) A qualified person under 30 CFR 75.151 shall monitor for methane as is required by the standard in the affected areas of the mine.
(g) The operator shall comply with all requirements of 30 CFR 75.323. The CleanSpace EX shall not be used if
(h) Employees shall be trained on how to properly use and take care of the CleanSpace EX according to manufacturer guidelines as well as all stipulations of the Decision and Order. Qualified miners shall receive training regarding the information in the Decision and Order before using equipment in the relevant part of the mine. A record of the training shall be kept and made available upon request.
(i) Within 60 days of the Decision and Order becoming finalized, the petitioner shall submit proposed revisions to the mine ventilation plan per 30 CFR 75.370, to be approved under the 30 CFR part 48 training plan by the Coal Mine Safety and Health District Manager. The revisions shall specify initial and refresher training. When the training is conducted, a MSHA Certificate of Training (Form 5000-23) shall be completed, with comments on the certificate noting non-permissible testing equipment training.
The petitioner asserts that the alternative method proposed will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before February 6, 2023.
You may submit comments identified by Docket No. MSHA-2022-0069 by any of the following methods:
1.
2.
3.
4.
S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.
The petitioner states that:
(a) They are seeking an alternative to the 3M Airstream helmet to provide miners with respirable protection against coal mine dust, a protection that can provide long-term health benefits.
(b) The 3M Airstream helmet has been used in mines for over 40 years. 3M faced component disruptions for the Airstream product, causing 3M to discontinue, globally, the Airstream on June 1, 2020. The ability to order an Airstream system and components ended in February 2020, with components available through June 2020. Currently, there are no replacement powered air purifying respirators (PAPRs) that meet the MSHA standard for permissibility. PAPRs provide a constant flow of filtered air and offer respiratory protection and comfort in hot working environments.
(c) The CleanSpace EX Powered Respirator (CleanSpace EX) is UL certified to the ANSI/UL 60079-11 standard and can be used in hazardous locations because it meets the intrinsic safety protection level. It is acceptable in other jurisdictions for use in mines with the potential for methane accumulation. The product is not MSHA approved, and the manufacturer is not pursuing approval. The standards for the approval of these respirators are an accepted alternative to MSHA's standards and provide the same level of protection.
(d) The CleanSpace EX uses a lithium-ion polymer battery that is neither accessible nor removable. The lithium-ion polymer battery and motor/blower assembly are both contained within the sealed power pack assembly. It charges as a complete unit.
(e) The CleanSpace EX can be easily disassembled and cleaned.
(f) The CleanSpace EX is designed to utilize either a half or full facemask and NIOSH-approved particulate filters. It does not impair vision nor communication. The CleanSpace EX provides more comfort, as it allows the miner to simultaneously wear the issued hardhat with a headlamp. The PAPR's
The petitioner proposes the following alternative method:
(a) Affected mine employees shall be trained in the proper use and maintenance of the CleanSpace EX in accordance with the established manufacturer guidelines. Mine employees shall also be trained to inspect the unit before each use to determine if there is any damage or defects to the unit that would negatively impact intrinsic safety. This inspection shall include all associated wiring and connections and shall take place prior to the equipment being taken underground.
(b) If it is determined that there is damage that may negatively impact the intrinsic safety, the PAPR shall be immediately removed from service.
(c) The CleanSpace EX user shall conduct daily examinations of the filter and replace as needed.
(d) When fitting a new filter on the CleanSpace EX, the Blocked Filter Alarm shall be tested by the user before the PAPR is put back into service.
(e) CleanSpace EX units shall be charged outby the last open crosscut and shall utilize the manufacturer approved battery charger. CleanSpace EX charging stations located underground shall be enclosed in a properly constructed steel box designed for such purpose.
(f) A qualified person under 30 CFR 75.151 shall monitor for methane as is required by the standard in the affected areas of the mine.
(g) The operator shall comply with all requirements of 30 CFR 75.323. The CleanSpace EX shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more methane is detected while the CleanSpace EX is being used, the equipment shall be deenergized immediately. When 1.5 percent or more methane is detected, the CleanSpace EX shall be withdrawn from the affected area outby the last open crosscut.
(h) Employees shall be trained on how to properly use and take care of the CleanSpace EX according to manufacturer guidelines as well as all stipulations of the Decision and Order. Qualified miners shall receive training regarding the information in the Decision and Order before using equipment in the relevant part of the mine. A record of the training shall be kept and made available upon request.
(i) Within 60 days of the Decision and Order becoming finalized, the petitioner shall submit proposed revisions to the mine ventilation plan per 30 CFR 75.370, to be approved under the 30 CFR part 48 training plan by the Coal Mine Safety and Health District Manager. The revisions shall specify initial and refresher training. When the training is conducted, a MSHA Certificate of Training (Form 5000-23) shall be completed, with comments on the certificate noting non-permissible testing equipment training.
The petitioner asserts that the alternative method proposed will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before February 6, 2023.
You may submit comments identified by Docket No. MSHA-2022-0068 by any of the following methods:
1.
2.
3.
4.
S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.
The petitioner states that:
(a) They are seeking an alternative to the 3M Airstream helmet to provide miners with respirable protection against coal mine dust, a protection that can provide long-term health benefits.
(b) The 3M Airstream helmet has been used in mines for over 40 years. 3M
(c) The CleanSpace EX Powered Respirator (CleanSpace EX) is UL certified to the ANSI/UL 60079-11 standard and can be used in hazardous locations because it meets the intrinsic safety protection level. It is acceptable in other jurisdictions for use in mines with the potential for methane accumulation. The product is not MSHA approved, and the manufacturer is not pursuing approval. The standards for the approval of these respirators are an accepted alternative to MSHA's standards and provide the same level of protection.
(d) The CleanSpace EX uses a lithium-ion polymer battery that is neither accessible nor removable. The lithium-ion polymer battery and motor/blower assembly are both contained within the sealed power pack assembly. It charges as a complete unit.
(e) The CleanSpace EX can be easily disassembled and cleaned.
(f) The CleanSpace EX is designed to utilize either a half or full facemask and NIOSH-approved particulate filters. It does not impair vision nor communication. The CleanSpace EX provides more comfort, as it allows the miner to simultaneously wear the issued hardhat with a headlamp. The PAPR's filter housing and fan assembly are above the shoulders, reducing ergonomic restrictions, freeing the miner from wearing the fan and filter unit around the waist, and eliminating hose attachments to the unit, which could create added hazards.
The petitioner proposes the following alternative method:
(a) Affected mine employees shall be trained in the proper use and maintenance of the CleanSpace EX in accordance with the established manufacturer guidelines. Mine employees shall also be trained to inspect the unit before each use to determine if there is any damage or defects to the unit that would negatively impact intrinsic safety. This inspection shall include all associated wiring and connections and shall take place prior to the equipment being taken underground.
(b) If it is determined that there is damage that may negatively impact the intrinsic safety, the PAPR shall be immediately removed from service.
(c) The CleanSpace EX user shall conduct daily examinations of the filter and replace as needed.
(d) When fitting a new filter on the CleanSpace EX, the Blocked Filter Alarm shall be tested by the user before the PAPR is put back into service.
(e) CleanSpace EX units shall be charged outby the last open crosscut and shall utilize the manufacturer approved battery charger. CleanSpace EX charging stations located underground shall be enclosed in a properly constructed steel box designed for such purpose.
(f) A qualified person under 30 CFR 75.151 shall monitor for methane as is required by the standard in the affected areas of the mine.
(g) The operator shall comply with all requirements of 30 CFR 75.323. The CleanSpace EX shall not be used if methane is detected in concentrations at or above 1.0 percent methane. When 1.0 percent or more methane is detected while the CleanSpace EX is being used, the equipment shall be deenergized immediately. When 1.5 percent or more methane is detected, the CleanSpace EX shall be withdrawn from the affected area outby the last open crosscut.
(h) Employees shall be trained on how to properly use and take care of the CleanSpace EX according to manufacturer guidelines as well as all stipulations of the Decision and Order. Qualified miners shall receive training regarding the information in the Decision and Order before using equipment in the relevant part of the mine. A record of the training shall be kept and made available upon request.
(i) Within 60 days of the Decision and Order becoming finalized, the petitioner shall submit proposed revisions to the mine ventilation plan per 30 CFR 75.370, to be approved under the 30 CFR part 48 training plan by the Coal Mine Safety and Health District Manager. The revisions shall specify initial and refresher training. When the training is conducted, a MSHA Certificate of Training (Form 5000-23) shall be completed, with comments on the certificate noting non-permissible testing equipment training.
The petitioner asserts that the alternative method proposed will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standard.
Pension Benefit Guaranty Corporation.
Notice of intention to request extension of OMB approval of information collections.
The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) extend approval, under the Paperwork Reduction Act, of collections of information in PBGC's regulations on multiemployer plans under the Employee Retirement Income Security Act of 1974 (ERISA). This notice informs the public of PBGC's intent and solicits public comment on the collections of information.
Comments must be received on or before March 6, 2023.
Comments may be submitted by any of the following methods:
•
•
•
Commenters are strongly encouraged to submit public comments electronically. PBGC expects to have limited personnel available to process comment that are submitted on paper through mail. Until further notice, any comments submitted on paper will be considered to the extent practicable.
All submissions received must include the agency's name (Pension Benefit Guaranty Corporation, or PBGC) and refer to multiemployer information collection. All comments received will be posted without change to PBGC's website at
Copies of the collections of information may also be obtained by writing to Disclosure Division, Office of the General Counsel, Pension Benefit Guaranty Corporation, 445 12th Street SW, Washington, DC 20024-2101, or calling 202-326-4040 during normal 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.
Hilary Duke (
OMB has approved and issued control numbers for seven collections of information in PBGC's regulations relating to multiemployer plans. These collections of information are described below. OMB approvals for these collections of information expire June 30, 2023. PBGC intends to request that OMB extend its approval of these collections of information for 3 years. 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. PBGC is soliciting public comments to—
• Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collections 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 collections 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 should identify the specific part number(s) of the regulation(s) to which they relate.
Sections 4203(f) and 4208(e)(3) of ERISA allow PBGC to permit a multiemployer plan to adopt special rules for determining whether a withdrawal from the plan has occurred, subject to PBGC approval.
The regulation specifies the information that a plan that adopts special rules must submit to PBGC about the rules, the plan, and the industry in which the plan operates. PBGC uses the information to determine whether the rules are appropriate for the industry in which the plan functions and do not pose a significant risk to the insurance system.
PBGC estimates that at most one plan sponsor submits a request each year under this regulation. The estimated annual burden of the collection of information is 4 hours and $10,000.
If an employer's covered operations or contribution obligation under a plan ceases, the employer must generally pay withdrawal liability to the plan. Section 4204 of ERISA provides an exception, under certain conditions, where the cessation results from a sale of assets. Among other things, the buyer must furnish a bond or escrow, and the sale contract must provide for secondary liability of the seller.
The regulation establishes general variances (rules for avoiding the bond/escrow and sale-contract requirements) and authorizes plans to determine whether the variances apply in particular cases. It also allows buyers and sellers to request individual variances from PBGC. Plans and PBGC use the information to determine whether employers qualify for variances. PBGC estimates that each year, 100 employers submit, and 100 plans respond to, variance requests under the regulation, and one employer submits a variance request to PBGC. The estimated annual burden of the collection of information is 1,050 hours and $501,000.
Section 4207 of ERISA allows PBGC to provide for abatement of an employer's complete withdrawal liability, and for plan adoption of alternative abatement rules, where appropriate.
Under the regulation, an employer applies to a plan for an abatement determination, providing information the plan needs to determine whether withdrawal liability should be abated, and the plan notifies the employer of its determination. The employer may, pending plan action, furnish a bond or escrow instead of making withdrawal liability payments, and must notify the plan if it does so. When the plan then makes its determination, it must so notify the bonding or escrow agent.
The regulation also permits a plan to adopt its own abatement rules and request PBGC approval. PBGC uses the information in such a request to determine whether the amendment should be approved.
PBGC estimates that each year at most one employer submits and one plan responds to an application for abatement of complete withdrawal liability, and no plan sponsors request approval of plan abatement rules from PBGC. The estimated annual burden of the collection of information is 0.5 hours and $1,000.
Section 4208 of ERISA provides for abatement, in certain circumstances, of an employer's partial withdrawal liability and authorizes PBGC to issue additional partial withdrawal liability abatement rules.
Under the regulation, an employer applies to a plan for an abatement determination, providing information the plan needs to determine whether withdrawal liability should be abated, and the plan notifies the employer of its determination. The employer may, pending plan action, furnish a bond or escrow instead of making withdrawal liability payments, and must notify the plan if it does so. When the plan then makes its determination, it must so notify the bonding or escrow agent.
The regulation also permits a plan to adopt its own abatement rules and request PBGC approval. PBGC uses the information in such a request to determine whether the amendment should be approved.
PBGC estimates that each year at most one employer submits and one plan responds to an application for abatement of partial withdrawal liability, and no plan sponsors request approval of plan abatement rules from PBGC. The estimated annual burden of the collection of information is 0.50 hours and $1,000.
Section 4211(c)(5)(A) of ERISA requires PBGC to prescribe how plans can, with PBGC approval, change the way they allocate unfunded vested benefits to withdrawing employers for purposes of calculating withdrawal liability.
The regulation prescribes the information that must be submitted to PBGC by a plan seeking such approval. PBGC uses the information to determine how the amendment changes the way the plan allocates unfunded vested benefits and how the amendment will affect the risk of loss to plan participants and PBGC.
PBGC estimates that 10 plan sponsors submit approval requests each year under this regulation. The estimated annual burden of the collection of information is 200 hours and $200,000.
Section 4219(c)(1)(D) of ERISA requires that PBGC prescribe regulations for the allocation of a plan's total unfunded vested benefits in the event of a “mass withdrawal.” Section 4209(c) of ERISA deals with an employer's liability for de minimis amounts if the employer withdraws in a “substantial withdrawal.”
The reporting requirements in the regulation give employers notice of a mass withdrawal or substantial withdrawal and advise them of their rights and liabilities. They also provide notice to PBGC so that it can monitor the plan, and they help PBGC assess the possible impact of a withdrawal event on participants and the multiemployer plan insurance program.
PBGC estimates that there are six mass withdrawals and three substantial withdrawals per year. The plan sponsor of a plan subject to a withdrawal covered by the regulation provides notices of the withdrawal to PBGC and to employers covered by the plan, liability assessments to the employers, and a certification to PBGC that assessments have been made. (For a mass withdrawal, there are two assessments and two certifications that deal with two different types of liability. For a substantial withdrawal, there is one assessment and one certification (combined with the withdrawal notice to PBGC).) The estimated annual burden of the collection of information is 15 hours and $49,500.
Under section 4220 of ERISA, a plan may within certain limits adopt special plan rules regarding when a withdrawal from the plan occurs and how the withdrawing employer's withdrawal liability is determined. Any such special rule is effective only if, within 90 days after receiving notice and a copy of the rule, PBGC either approves or fails to disapprove the rule. The regulation provides rules for requesting PBGC's approval of an amendment. PBGC needs the required information to identify the plan; evaluate the risk of loss, if any, posed by the plan amendment; and determine whether to approve or disapprove the amendment.
PBGC estimates that at most one plan sponsor submits an approval request per year under this regulation. The estimated annual burden of the collection of information is 2 hours and $7,000 dollars.
Issued in Washington, DC.
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 December 28, 2022, 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 December 27, 2022, 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
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 December 28, 2022, 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 December 28, 2022, 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 December 28, 2022, 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 December 27, 2022, 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 December 27, 2022, 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 extend the implementation date for certain risk checks of Rule Nasdaq Equity 6, Section 5 (Risk Settings) that provide Participants with additional optional settings.
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.
Nasdaq is filing this proposal to extend the implementation date of Rule Nasdaq Equity 6, Section 5 (Risk Settings) that provide Participants with additional optional settings to Q1 2023; and to make certain technical modification without changing the substance of the rules.
Nasdaq proposed rule changes under Rule Nasdaq Equity 6, Section 5 (Risk Settings) to provide Participants
Nasdaq indicated that it intends to implement the proposed rule changes on or before December 30, 2022. Due to re-prioritization, Nasdaq is delaying the implementation of the additional, optional risk checks, as described in the Proposal, until March 31, 2023. The Exchange will issue an Equity Trader Alert to members announcing the exact date the Exchange will implement the risk protections.
Nasdaq also proposes to modify the risk setting titled “Restricted Stock List.” As described in the Proposal, this control allows a Participant to restrict the types of securities transacted by setting a list of symbols for which orders cannot be entered. This control also allows Participants to set an easy to borrow list, which is a list of symbols for which short sale orders may be entered. Short sale orders for symbols not on the easy to borrow list will not be accepted; however, Participants will have an option to indicate that short sales orders are permitted for all symbols.
Nasdaq proposes to modify this risk check to such that a Participant can set a hard to borrow list, which is a list of symbols for which short sale orders may not be entered, rather than an easy to borrow list. Short sale orders for symbols not on the hard to borrow list will be accepted; however, Participants will have an option to indicate that short sales orders are permitted for all symbols by not maintaining a hard to borrow list. Nasdaq believes that this modification does not substantively change the Restricted Stock List risk setting. This setting continues to be similar to Interpretations and Policies .01(d) of BZX Rule 11.13.
Nasdaq also proposes to modify Market Impact Check and Gross Exposure Check to correct typographical errors and clarify the rule language without substantively changing it.
As stated above, the Exchange intends to implement the proposed rule changes on or before March 31, 2023. The Exchange will issue an Equity Trader Alert to members announcing the exact date the Exchange will implement the risk protections.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The purpose of this proposal is to modify the timing of the planned implementation for the optional risk checks, described above, and to inform
Nasdaq believes that the proposed changes to modify the risk setting titled “Restricted Stock List” is a technical modification that does not change the substance of this rule. Similarly, Nasdaq believes that the proposal to modify Market Impact Check and Gross Exposure Check to correct typographical errors and clarify the rule language without substantively changing it is ministerial.
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. As explained above, the purpose of this proposal is to modify the timing of the planned implementation for the optional additional risk checks and to inform the SEC and market participants of that change. The existing Nasdaq products will continue to be available, and the implementation delay will impact all market participants equally. The Exchange does not expect the date change to place any burden on competition. Similarly, Nasdaq believes that correction of typographical errors, technical changes, and clarifications of existing rules do not place any burden on competition because these changes do not affect the substance of the existing rules.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 607 requires disclosure on each new account and on a yearly basis thereafter, on the annual statement, the firm's policies regarding receipt of payment for order flow from any market makers, exchanges or exchange members to which it routes customers' order in national market system securities for execution; and
The information collected pursuant to Rule 607 is necessary to facilitate the establishment of a national market system for securities. The purpose of the rule is to ensure that customers are adequately apprised of the broker-dealer's order routing practices with respect to the customer's order, in furtherance of the Commission's statutory mandate to protect investors.
The Commission estimates that approximately 3,643 respondents will make the third-party disclosures required in the collection of information requirements to 183,511,801 customer accounts each year. The Commission estimates that the average number of hours necessary for each respondent to comply with Rule 607 per year is 39.714 hours, which results in an average aggregated annual burden of 144,678.102 hours.
Written comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing by March 6, 2023.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: David Bottom, Director/Chief Information Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to: PRA_
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to make permanent the temporary rule relief in Rule 36.30 to allow DMM units to maintain a telephone line at its trading post location, which relief expires on the earlier of a full reopening of the Trading Floor facilities to DMMs or after the Exchange closes on December 31, 2022. 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 make permanent the temporary rule relief to Rule 36.30 to allow a DMM unit may maintain a telephone line at its trading post location, which relief expires on the earlier of a full reopening of the Trading Floor facilities to DMMs or after the Exchange closes on December 31, 2022.
In connection with its response to COVID-19 and its impact on the Trading Floor, the Exchange modified certain of its rules to provide temporary relief,
In order to address the technological shift in how business communications are conducted in the wake of the pandemic, and how business communications will likely continue
The Exchange believes this proposed rule change would continue to provide DMMs with flexibility to communicate with staff not assigned to the Trading Floor, but who are working remotely. The Exchange believes that remote work options for employees—whether full or part-time—have become a permanent feature of the modern workplace and are likely to persist once the pandemic fully subsides. As such, the Exchange believes that allowing DMM units to continue communicating with employees working off-site (at designated phone numbers shared with the Exchange) would continue to provide flexibility to DMMs to maintain necessary communication with staff at the DMM firm with whom they would otherwise communicate if such staff were physically present at an office. As a result, the Exchange believes the proposed change would enable DMM units to continue to efficiently allocate resources and permit Floor-based staff to communicate more easily and seamlessly with off-Floor staff whether such off-Floor staff are working at an office or remotely.
As is the case today, Rule 36.30 telephones installed at the DMM unit trading post “shall not be used for the purpose of transmitting to the Floor orders for the purchase or sale of securities.”
The proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed rule change would remove impediments to and perfect the mechanism of a free and open market and a national market system because the proposed rule change would continue to provide DMMs with flexibility to communicate with staff not assigned to the Trading Floor, but who are working remotely. The Exchange believes that remote work options for employees—whether full or part-time—have become a permanent feature of the modern workplace and are likely to persist once the pandemic fully subsides. As such, the Exchange believes that allowing DMM units to communicate with employees working remotely would continue to enhance communications and ease the logistical burdens associated with operating with staff working on the Trading Floor and staff working remotely and provide DMMs with needed flexibility in managing their operations. As a result, the Exchange believes the proposed change would enable DMM units to more efficiently allocate resources and permit Floor-based staff to communicate more easily and seamlessly with off-Floor staff whether such off-Floor staff are working at an office or remotely.
The Exchange also believes that the proposal is designed to prevent fraudulent and manipulative acts and practices and would be consistent with the public interest and the protection of investors because DMM units would continue to need to identify the persons working in locations other than the DMM unit's off-Floor offices and submit the telephone numbers of such persons to the Exchange in advance. This additional safeguard would provide the Exchange with information that may be important to determining whether DMM units are only communicating with personnel from their off-Floor offices in a manner permitted under Rule 98. As such, the Exchange believes that the continuation of the existing safeguards are appropriate for supervising and monitoring use of telephones on the Exchange's Trading Floor consistent with the objectives of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not designed to address any competitive issues but rather would make permanent amendments to Rule 36.30 that enhance a DMM unites ability to communicate with staff working remotely (
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest because it will allow the Exchange to it will allow the rules discussed above to remain in effect for DMM firms to continue to operate with a mix of employees working remotely and others physically present on the Trading Floor. Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposal operative upon filing.
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission” or “SEC”)
Notice.
The following is a notice of applications for deregistration under section 8(f) of the Investment Company Act of 1940 for the month of December 2022. A copy of each application may be obtained via the Commission's website by searching for the applicable file number listed below, 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
The Commission:
Shawn Davis, Assistant Director, at (202) 551-6413 or Chief Counsel's Office at (202) 551-6821; SEC, Division of Investment Management, Chief Counsel's Office, 100 F Street NE, Washington, DC 20549-8010.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “Death is Not the End” at the Rubin Museum of Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “From Depero to Rotella: Italian Commercial Posters between Advertising and Art” at the Center for Italian Modern Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “Monet/Mitchell: Painting the French Landscape” at the Saint Louis Art Museum, St. Louis, Missouri, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Surface Transportation Board.
Notice tentatively approving and authorizing finance transaction.
Transdev Group, S.A. (Transdev), a noncarrier, its noncarrier subsidiary Transdev North America, Inc. (TNA), and TNA's carrier subsidiary Transdev Services, Inc. (TSI) (collectively, Applicants) have filed an application for TNA to acquire all voting securities of noncarrier First Transit Topco Inc. (Topco), and thereby acquire control of a Topco subsidiary, First Transit, Inc. (FT), an interstate passenger motor carrier, from Recess Holdco LLC, a noncarrier affiliate of FT. The Board is tentatively approving and authorizing this transaction. If no opposing comments are timely filed, this notice will be the final Board action.
Comments must be filed by February 21, 2023. If any comments are filed, Applicants may file a reply by March 6, 2023. If no opposing comments are filed by February 21, 2023, this decision will be final on February 22, 2023.
Comments may be filed with the Board either via e-filing on the Board's website or mailing to the Board's offices. Comments may be e-filed at
Jonathon Binet at (202) 245-0368. Assistance for the hearing impaired is available through the Federal Relay Service at (800) 877-8339.
According to the application,
The application explains that under this transaction, all voting securities of Topco would be acquired by TNA, and Topco would become a direct subsidiary of TNA and an indirect subsidiary of Transdev. (Appl. 2, 6.) Topco, a noncarrier, is an intermediate parent company of FT,
Under 49 U.S.C. 14303(b), the Board must approve and authorize a transaction that it finds consistent with the public interest, taking into consideration at least (1) the effect of the proposed transaction on the adequacy of transportation to the public, (2) the total fixed charges resulting from the proposed transaction, and (3) the interest of affected carrier employees. Applicants have submitted information required by 49 CFR 1182.2, including information demonstrating that the proposed transaction is consistent with the public interest under 49 U.S.C. 14303(b),
Applicants assert that the proposed transaction is not expected to have an adverse impact on the adequacy of transportation services available to the public. (Appl. 7-9;
Applicants argue that, for the same reasons that the transaction will not have an adverse impact on the adequacy of transportation services available to the public, it will also not adversely affect competition. (
Applicants state that the proposed transaction will not increase fixed charges payable by FT. (Appl. 9.) Applicants explain that they intend to pay the purchase price with a combination of cash in hand and a portion of a revolving credit facility that has been in place for TNA and affiliates since 2019; FT will not be added as a co-obligor on the credit facility. (
Based on Applicants' representations, the Board finds that the acquisition as proposed in the application is consistent with the public interest and should be tentatively approved and authorized. If any opposing comments are timely filed, these findings will be deemed vacated, and, unless a final decision can be made on the record as developed, a procedural schedule will be adopted to reconsider the application.
This action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available at
1. The proposed transaction is approved and authorized, subject to the filing of opposing comments.
2. If opposing comments are timely filed, the findings made in this notice will be deemed vacated.
3. This notice will be effective February 22, 2023, unless opposing comments are filed by February 21, 2023. If any comments are filed, Applicant may file a reply by March 6, 2023.
4. A copy of this notice will be served on: (1) the U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590; (2) the U.S. Department of Justice, Antitrust Division, 10th Street & Pennsylvania Avenue NW, Washington, DC 20530; and (3) the U.S. Department of Transportation, Office of the General Counsel, 1200 New Jersey Avenue SE, Washington, DC 20590.
By the Board, Board Members, Fuchs, Hedlund, Oberman, Primus, and Schultz.
On December 20, 2022, the Colorado Pacific Rio Grande Railroad, LLC (CP Rio Grande), a non-carrier, filed a verified notice of exemption under 49
According to the verified notice, the proposed transaction is the culmination of involuntary Chapter 11 bankruptcy proceedings before the United States Bankruptcy Court for the District of Colorado. The verified notice states that, on November 17, 2022, KCVN LLC (KCVN) was the successful bidder at auction for substantially all the assets of SLRG, and an Asset Purchase Agreement was executed between SLRG and KCVN “or its permitted assignee.” The verified notice further states that the Bankruptcy Court approved the sale to KCVN or its permitted assignee pursuant to the Asset Purchase Agreement on November 29, 2022. According to the verified notice, on December 19, 2022, KCVN assigned all of its rights in the Asset Purchase Agreement to CP Rio Grande.
CP Rio Grande certifies that its projected annual revenues from this transaction will not exceed $5 million and will not result in CP Rio Grande becoming a Class II or Class I rail carrier. CP Rio Grande further certifies that the transaction involves an interchange commitment that would limit future interchange with a third-party carrier other than UP in Walsenburg Yard,
The transaction may be consummated on or after January 19, 2023, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than January 12, 2023 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36656, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on SLRG's representative: Thomas W. Wilcox, Law Office of Thomas W. Wilcox, LLC, 1629 K Street NW, Suite 300, Washington, DC 20006.
According to CP Rio Grande, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board,
Federal Aviation Administration (FAA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The collection involves gathering data from airport sponsors and planning agencies to determine eligibility, ensure compliance with Federal requirements, and ensure proper use of Federal funds and project accomplishments for the Airport Improvement Program. Submission is required to receive funds.
Written comments should be submitted by March 6, 2023.
Please send written comments:
Carlos Fields by email at:
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt nine individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
The exemptions are applicable on December 30, 2022. The exemptions expire on December 30, 2024.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to
On November 17, 2022, FMCSA published a notice announcing receipt of applications from nine individuals requesting an exemption from the hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested comments from the public (87 FR 69076). The public comment period ended on December 19, 2022, and one comment was received.
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(11).
The physical qualification standard for drivers regarding hearing found in § 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.
This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid (35 FR 6458, 6463 [Apr. 22, 1970] and 36 FR 12857 [July 8, 1971], respectively).
FMCSA received one comment in this proceeding. An individual anonymously commented that they are in favor of “granting exemptions for the applicants provided the applicants are otherwise qualified to drive CMVs in interstate traffic.” However, they believe that the exemption should not be necessary for individuals who are hearing impaired as these individuals do not pose any risk to safety. The individual notes that based on FMCSA's continued decisions to grant exemptions to individuals who are hearing impaired and studies that support hearing impaired individuals are not a risk to safety, and that “Congress does not have a legitimate interest in disallowing persons with hearing impairments from obtaining CDLs without first applying for an exemption and being submitted to the lengthy public comment process.” They go on to ask why there is a general law from 1971 banning CMV drivers who are deaf or hard of hearing from driving that requires the driver to appeal to a bureaucratic process. The majority of their comment falls outside the scope of this notice. FMCSA grants exemptions based an individual assessment of each applicant that focuses on whether an equal or greater level of safety would likely be achieved by permitting each of these drivers to drive in interstate commerce.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on relevant scientific information and literature, and the 2008 Evidence Report, “Executive Summary on Hearing, Vestibular Function and Commercial Motor Driving Safety.” The evidence report reached two conclusions regarding the matter of hearing loss and CMV driver safety: (1) no studies that examined the relationship between hearing loss and crash risk exclusively among CMV drivers were identified; and (2) evidence from studies of the private driver's license holder population does not support the contention that individuals with hearing impairment are at an increased risk for a crash. In addition, the Agency reviewed each applicant's driving record found in the Commercial Driver's License Information System, for commercial driver's license (CDL) holders, and inspections recorded in the Motor Carrier Management Information System. For non-CDL holders, the Agency reviewed the driving records from the State Driver's Licensing Agency. Each applicant's record demonstrated a safe driving history. Based on an individual assessment of each applicant that focused on whether an equal or greater level of safety would likely be achieved by permitting each of these drivers to drive in interstate commerce, the Agency finds the drivers granted this exemption have demonstrated that they do not pose a risk to public safety.
Consequently, FMCSA finds further that in each case exempting these applicants from the hearing standard in § 391.41(b)(11) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).
The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: (1) each driver must report any crashes or accidents as defined in § 390.5T; (2) each driver must report all citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 to FMCSA; and (3) each driver is prohibited from operating a motorcoach or bus with passengers in interstate commerce. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the exemption does not exempt the individual from meeting the applicable CDL testing requirements.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the nine exemption applications, FMCSA exempts the following drivers from the hearing standard; in § 391.41(b)(11), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 25 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates provided below. Comments must be received on or before February 6, 2023.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2012-0154, Docket No. FMCSA-2014-0103, Docket No. FMCSA-2014-0106, Docket No. FMCSA-2014-0384, Docket No. FMCSA-2014-0386, Docket No. FMCSA-2015-0328, Docket No. FMCSA-2016-0002, Docket No. FMCSA-2017-0057, Docket No. FMCSA-2017-0058, Docket No. FMCSA-2018-0135, Docket No. FMCSA-2018-0136, Docket No. FMCSA-2019-0111, or Docket No. FMCSA-2020-0028 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2012-0154, Docket No. FMCSA-2014-0103, Docket No. FMCSA-2014-0106, Docket No. FMCSA-2014-0384, Docket No. FMCSA-2014-0386, Docket No. FMCSA-2015-0328, Docket No. FMCSA-2016-0002, Docket No. FMCSA-2017-0057, Docket No. FMCSA-2017-0058, Docket No. FMCSA-2018-0135, Docket No. FMCSA-2018-0136, Docket No. FMCSA-2019-0111, or Docket No. FMCSA-2020-0028) indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding hearing found in 49 CFR 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.
This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid, (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971), respectively).
The 25 individuals listed in this notice have requested renewal of their exemptions from the hearing standard in § 391.41(b)(11), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 25 applicants has satisfied the renewal conditions for obtaining an exemption from the hearing requirement. The 25 drivers in this notice remain in good standing with the Agency. In addition, for commercial
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of January and are discussed below.
As of January 15, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following 16 individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers:
The drivers were included in docket numbers FMCSA-2012-0154, FMCSA-2014-0103, FMCSA-2014-0106, FMCSA-2014-0384, FMCSA-2014-0386, FMCSA-2016-0002, FMCSA-2017-0057, FMCSA-2017-0058, FMCSA-2018-0135, FMCSA-2018-0136, or FMCSA-2019-0111. Their exemptions are applicable as of January 15, 2023 and will expire on January 15, 2025.
As of January 22, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following nine individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers:
The drivers were included in docket numbers FMCSA-2015-0328 or FMCSA-2020-0028. Their exemptions are applicable as of January 22, 2023 and will expire on January 22, 2025.
The exemptions are extended subject to the following conditions: (1) each driver must report any crashes or accidents as defined in § 390.5T; and (2) report all citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 to FMCSA; and (3) each driver prohibited from operating a motorcoach or bus with passengers in interstate commerce. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the exemption does not exempt the individual from meeting the applicable CDL testing requirements. Each exemption will be valid for 2 years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 25 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the hearing requirement in § 391.41(b)(11). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for seven individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before February 6, 2023.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2015-0323, Docket No. FMCSA-2016-0008, Docket No. FMCSA-2018-0056, or Docket No. FMCSA-2019-0035 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2015-0323, Docket No. FMCSA-2016-0008, Docket No. FMCSA-2018-0056, or Docket No. FMCSA-2019-0035), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
The seven individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the seven applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The seven drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous 2-year exemption period. In addition, for commercial driver's license (CDL) holders, the Commercial Driver's License Information System and the Motor Carrier Management Information System are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency. These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of 2 years is likely to achieve a level of safety equal to that existing without the exemption.
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of
As of January 1, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following six individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2015-03023, FMCSA-2016-0008, FMCSA-2018-0056, or FMCSA-2019-0035. Their exemptions are applicable as of January 1, 2023 and will expire on January 1, 2025.
As of January 11, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), Robert Schauer (IA) has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers.
This driver was included in docket number FMCSA-2016-0008. Their exemption is applicable as of January 11, 2023 and will expire on January 11, 2025.
The exemptions are extended subject to the following conditions: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based on its evaluation of the seven exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 28 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
The exemptions are applicable on October 24, 2022. The exemptions expire on October 24, 2024. Comments must be received on or before February 6, 2023.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2012-0294, Docket No. FMCSA-2013-0443, Docket No. FMCSA-2013-0444, Docket No. FMCSA-2014-0212, Docket No. FMCSA-2014-0213, Docket No. FMCSA-2014-0382, Docket No. FMCSA-2015-0321, Docket No. FMCSA-2015-0323, Docket No. FMCSA-2018-0028, Docket No. FMCSA-2018-0050, Docket No. FMCSA-2018-0051, Docket No. FMCSA-2018-0052, Docket No. FMCSA-2018-0054, Docket No. FMCSA-2019-0034, Docket No. FMCSA-2020-0046, Docket No. FMCSA-2020-0049, or Docket No. FMCSA-2020-0050 using any of the following methods:
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To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2012-0294, Docket No. FMCSA-2013-0443, Docket No. FMCSA-2013-0444, Docket No. FMCSA-2014-0212, Docket No. FMCSA-2014-0213, Docket No. FMCSA-2014-0382, Docket No. FMCSA-2015-0321, Docket No. FMCSA-2015-0323, Docket No. FMCSA-2018-0028, Docket No. FMCSA-2018-0050, Docket No. FMCSA-2018-0051, Docket No. FMCSA-2018-0052, Docket No. FMCSA-2018-0054, Docket No. FMCSA-2019-0034, Docket No. FMCSA-2020-0046, Docket No. FMCSA-2020-0049, or Docket No. FMCSA-2020-0050), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period.
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statute also allows the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
The 28 individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 28 applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The 28 drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous 2-year exemption period. In addition, for commercial driver's license (CDL) holders, the Commercial Driver's License Information System and the Motor Carrier Management Information System are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency. These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in
As of October 24, 2022, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following 28 individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2012-0294, FMCSA-2013-0443, FMCSA-2013-0444, FMCSA-2014-0212, FMCSA-2014-0213, FMCSA-2014-0382, FMCSA-2015-0321, FMCSA-2015-0323, FMCSA-2018-0028, FMCSA-2018-0050, FMCSA-2018-0051, FMCSA-2018-0052, FMCSA-2018-0054, FMCSA-2019-0034, FMCSA-2020-0046, FMCSA-2020-0049, or FMCSA-2020-0050. Their exemptions are applicable as of October 24, 2022 and will expire on October 24, 2024.
The exemptions are extended subject to the following conditions: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based on its evaluation of the 28 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years unless revoked earlier by FMCSA.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice.
PHMSA is publishing this notice to solicit public comments on a request for special permit received from Columbia Gas Transmission, LLC (TCO). The special permit request is seeking relief from compliance with certain requirements in the federal pipeline safety regulations. At the conclusion of the 30-day comment period, PHMSA will review the comments received from this notice as part of its evaluation to grant or deny the special permit request.
Submit any comments regarding this special permit request by February 6, 2023.
Comments should reference the docket number for this special permit request and may be submitted in the following ways:
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There is a privacy statement published on
PHMSA received a special permit request from TCO, a subsidiary of TC Energy, Inc., seeking a waiver from the requirements of 49 CFR 192.611(a) and (d): Change in class location: Confirmation or revision of maximum allowable operating pressure and 49 CFR 192.619(a): Maximum allowable operating pressure: Steel or plastic pipelines.
This special permit is being requested in lieu of pipe replacement, pressure reduction, or new pressure tests for a Class 1 to 3 location change on one (1) gas transmission special permit segment totaling 1,450 feet (approximately 0.275 miles). This pipeline segment, which has changed from a Class 1 to Class 3 location, is as follows:
The special permit request, proposed special permit with conditions, and draft environmental assessment (DEA) for the above listed TCO pipeline segment is available for review and public comments in Docket Number PHMSA-2022-0166. PHMSA invites interested persons to review and submit comments on the special permit request and DEA in the docket. Please include any comments on potential safety and environmental impacts that may result if the special permit is granted. Comments may include relevant data.
Before issuing a decision on the special permit request, PHMSA will evaluate all comments received on or before the comments closing date. Comments received after the closing date will be evaluated, if it is possible to do so without incurring additional expense or delay. PHMSA will consider each relevant comment it receives in making its decision to grant or deny this special permit request.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice.
PHMSA is publishing this notice to solicit public comments on a request for special permit received from East Tennessee Natural Gas Transmission, LLC (ETNG). The special permit request is seeking relief from compliance with certain requirements in the Federal pipeline safety regulations. At the conclusion of the 30-day comment period, PHMSA will review the comments received from this notice as part of its evaluation to grant or deny the special permit request.
Submit any comments regarding this special permit request by February 6, 2023.
Comments should reference the docket number for the specific special permit request and may be submitted in the following ways:
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There is a privacy statement published on
PHMSA received a special permit request from ETNG, owned and operated by Enbridge Inc., seeking a waiver from the requirements of 49 CFR 192.53(c), 192.121, 192.144, 192.149, 192.150, 192.619(a), 192.624, 192.710, and 192.714, for the use of composite pipe (Smartpipe®) and fittings to replace approximately 0.64 miles of an interstate gas transmission pipeline located in a Class 3 location in Roanoke County, Virginia. Smartpipe® is a flexible reinforced thermoplastic pipe that is not authorized by 49 CFR part 192. ETNG proposes to insert the Smartpipe®, 6-inch inside diameter and 7.6-inch outside diameter, into the existing 8.625-inch outside diameter steel pipeline, known as ETNG's Line No. 3320A-100 Pipeline. ETNG's request proposes the pipe pulling tensile force would be limited to 40,000 pounds during installation of the Smartpipe®, which is 44 percent of the Smartpipe® rating of 90,000 pounds. The request also proposes that the Line No. 3320A-100 Pipeline would have a maximum allowable operating pressure of 813 pounds per square inch gauge after installation of the Smartpipe®. The existing Line No. 3320A-100 Pipeline is externally coated with coal tar enamel.
The special permit request, proposed special permit with conditions, and draft environmental assessment (DEA) for the ETNG Line No. 3320A-100 Pipeline are available for review and public comment in the Docket No. PHMSA-2022-0167. PHMSA invites interested persons to review and submit comments on the special permit request, proposed special permit with conditions, and DEA in the docket. Please include any comments on potential safety and environmental impacts that may result if the special permit is granted. Comments may include relevant data.
Before issuing a decision on the special permit requests, PHMSA will evaluate all comments received on or before the comment closing date. Comments received after the closing date will be evaluated, if it is possible to do so without incurring additional expense or delay. PHMSA will consider each relevant comment it receives in making its decision to grant or deny this request.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 8975, Country-by-Country Report, and Schedule A (Form 8975), Tax Jurisdiction and Constituent Entity Information.
Written comments should be received on or before March 6, 2023 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of this collection should be directed to Jon Callahan, (737) 800-7639, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The IRS is currently seeking comments concerning the following information collection tools, reporting, and record-keeping requirements:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 1097-BTC, Bond Tax Credit.
Written comments should be received on or before March 6, 2023 to be assured of consideration.
Direct all written comments to Andres Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of this collection should be directed to Jon Callahan, (737) 800-7639, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The IRS is currently seeking comments concerning the following information collection tools, reporting, and record-keeping requirements:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Financial Services Center (FSC), Department of Veterans Affairs (VA).
Notice of a new system of records.
Pursuant to the Privacy Act of 1974, notice is hereby given that the Department of Veterans Affairs (VA) proposes to establish a new system of records entitled, “Online Forms Submission” (OFS). This system is used by VA employees and contractors to submit a request (
Comments on this new system of records must be received no later than 30 days after date of publication in the
Comments may be submitted through
Howard Ebron, IT Specialist, FSC, 7600 Metropolis Dr., Austin, TX 78744, Telephone: 512-460-5606 (Note: this is not a toll-free number), Email:
OFS is an online form entry portal that provides VA employees and contractors the ability to submit a request (
The Senior Agency Official for Privacy, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Kurt D. DelBene, Assistant Secretary for Information and Technology and Chief Information Officer, approved this document on November 28, 2022 for publication.
Online Forms Submission—VA (211VA0478C)
Unclassified
Records are maintained at the FSC, 7600 Metropolis Dr., Austin, TX 78744.
Jonathan Lindow Information System Owner, FSC, 7600 Metropolis Dr., Austin, TX 78744 Email:
Budget and Accounting Act of 1950 and General Accounting Office Title 8, Chapter 3. Social Security Numbers (SSN) are used to index and store pay affecting documents. SSNs are required from the customer for Internal Revenue Service (IRS) tax reporting and cannot be eliminated. SSNs are required for security clearance processing, which is authorized under Executive Orders 9397, 10450, 10865, 12333 and 12356; sections 3301 and 9101 of 5 U.S.C. and Homeland Security Presidential Directive 12.
The OFS system provides a central web-based location for submitting forms electronically. OFS allows for the creation of request forms for submittal, approval, completion routing, auditing and administration. Approval and completion groups can be created and assigned various tasks for any form and all routing is data-driven. Audit information is collected about every submitted form for tracking and process-flows are reviewed for efficiency. All form submissions are stored electronically in a centralized database. OFS ensures that only relevant personnel are involved with completing the requested action(s) on the forms, thereby improving process efficiency and accuracy.
These records include information on current and former VA Employees and Contractors.
These records include name, SSN, business email address, personal email address, business phone number and home address.
Information in this system of records is provided by the VA Employee or Contractor and pulled from the global address list and/or active directory.
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(a) VA or any component thereof;
(b) Any VA employee in his or her official capacity;
(c) Any VA employee in his or her individual capacity where DOJ has agreed to represent the employee; or
(d) The United States, where VA determines that litigation is likely to affect the agency or any of its components,
is a party to such proceedings or has an interest in such proceedings, and VA determines that use of such records is
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Records for this system are stored electronically in the OFS database.
OFS forms can be retrieved based on unique ID, search based on type of form and submission date. OFS roles include Auditor, OFS Admin, Basic User and Supervisor and the user roles which dictate the kind of the data that can be viewed by the user.
Records in this system are retained and disposed of in accordance with the schedule approved by the Archivist of the United States, General Records Schedules: 3.1, Item 020; 5.6, Item 111; 5.6, Item 120; 1.1, Item 011; 5.6, Item 010; 2.2, Item 010; and, 2.2, Item 080.
Information in the system is protected from unauthorized access through administrative, physical, and technical safeguards. Access to computerized information is restricted to authorized OFS personnel on a need-to-know basis. OFS personnel require valid Personal Identity Verification cards and need to be assigned relevant user roles to access the OFS system.
Individuals seeking information on the existence and content of records in this system pertaining to them should contact the system manager(s) in writing as indicated above. A request for access to records must contain the requester's full name, address, telephone number, be signed by the requester, and describe the records sought in sufficient detail to enable VA personnel to locate them with a reasonable amount of effort.
Individuals seeking to contest or amend records in this system pertaining to them should contact the system manager in writing as indicated above. A request to contest or amend records must state clearly and concisely what records is being contested, the reasons for contesting it, and the proposed amendment to the record.
Generalized notice is provided by the publication of this notice. For specific notice, see Record Access Procedure, above.
No privacy exemptions exist for the system.
None.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS is reassessing the statutorily mandated findings supporting its January 19, 2021, final rule and Regulations Governing Taking Marine Mammals Incidental to Geophysical Survey Activities in the Gulf of Mexico issued pursuant to the Marine Mammal Protection Act (MMPA), in light of updated information following the discovery that the estimates of incidental take of marine mammals anticipated from the activities analyzed for the 2021 regulations were erroneous. The correction of this error, as well as other newly available and pertinent information, has bearing on the analyses supporting some of the prior findings in the 2021 final rule and the taking allowable under the regulations. There are no changes to the specified activities or the specified geographical region in which those activities would be conducted, nor to the original 5-year period of effectiveness. Here, in light of the new information, NMFS presents new “negligible impact” analyses supporting our preliminary affirmance of the negligible impact determinations for all species, and proposes to affirm that the existing regulations, which contain mitigation, monitoring, and reporting requirements, are consistent with the “least practicable adverse impact standard” of the MMPA. Pursuant to the MMPA, NMFS is requesting comments on its revised negligible impact analyses and proposed findings and proposed retention of the existing regulations as consistent with the MMPA's least practicable adverse impact standard and will consider public comments relevant to this proposed rule prior to issuing any final rule. Agency responses will be included in the notice of the final decision.
Comments and information must be received no later than February 6, 2023.
Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to
Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.
On January 19, 2021 (86 FR 5322), in response to a petition request from the Bureau of Ocean Energy Management (BOEM), NMFS issued a final rule under the MMPA, 16 U.S.C. 1361
Errors discovered in the maximum annual and 5-year take numbers during implementation of the ITR preclude NMFS from issuing LOAs for the full amount of activity described by BOEM in the petition (as revised) and intended to be covered under the ITR. As a result, the utility of the rule has been limited. NMFS has produced corrected take estimates, including updates to the best available science incorporated to the take estimation process (
Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to 5 years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the Proposed Mitigation section), as well as monitoring and reporting requirements. Under NMFS' implementing regulations for section 101(a)(5)(A), NMFS issues LOAs to individuals (including entities) seeking authorization for take under the activity-specific incidental take regulations (50 CFR 216.106).
Following is a summary of the major provisions of the current regulations regarding geophysical survey activities, which NMFS proposes to reaffirm. The regulations contain requirements for mitigation, monitoring, and reporting, including:
• Standard detection-based mitigation measures, including use of visual and acoustic observation to detect marine mammals and shut down acoustic sources in certain circumstances;
• A time-area restriction designed to avoid effects to bottlenose dolphins in times and places believed to be of particular importance;
• Vessel strike avoidance measures; and
• Monitoring and reporting requirements.
The ITR would continue to govern and allow for the issuance of LOAs for the take of marine mammals incidental to the specified activity (which is unchanged from what was described in the 2021 final rule), within the upper bounds of take evaluated herein.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to as “mitigation”); and set forth requirements pertaining to the monitoring and reporting of the takings. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
On October 17, 2016, BOEM submitted a revised petition
NMFS published a notice of proposed rulemaking in the
On February 24, 2020, BOEM submitted a notice to NMFS of its “updated proposed action and action area for the ongoing [ITR] process[.]” This update consisted of removal of the area then under a Congressional leasing moratorium under the Gulf of Mexico Energy Security Act (GOMESA) (Sec. 104, Pub. L. 109-432)
While processing requests for individual LOAs under the ITR using the methodology for developing LOA-specific take numbers presented in the rule, NMFS discovered that the estimated maximum annual incidental take and estimated total 5-year take from all survey activities that BOEM projected for its revised scope appeared to be in error, in that maximum annual incidental take was likely to be reached much sooner than was anticipated for some species based on the level of activity described in BOEM's petition (as revised in 2020). NMFS contacted BOEM regarding this, and BOEM determined that, when it reduced its scope of specified activity in March 2020 by removing the GOMESA moratorium area from its proposed action, it underestimated the level of take by inadvertently factoring species density estimates into its revised exposure estimates twice. Generally, this miscalculation caused BOEM to underestimate the total predicted exposures of species from all survey activities in its revision to the petition, most pronouncedly for those species with the lowest densities (
BOEM provided NMFS with an explanation of the miscalculation with regard to its incidental take estimate and revised take estimates. See the Estimated Take section for additional discussion. NMFS then determined it would conduct a rulemaking to analyze the revised take estimates and, if appropriate, to revise its incidental take rule accordingly.
Since issuance of the 2021 final rule (at time this proposed rule was submitted to the
In 2017, BOEM produced a final Programmatic Environmental Impact Statement (PEIS) to evaluate the direct, indirect, and cumulative impacts of geological and geophysical survey activities in the GOM, pursuant to requirements of NEPA. These activities include geophysical surveys, as are described in the MMPA petition submitted by BOEM to NMFS. The PEIS is available online at:
In 2020, NMFS prepared a Record of Decision (ROD) for the following purposes: (1) to adopt BOEM's Final PEIS to support NMFS' analysis associated with issuance of incidental take authorizations pursuant to section 101(a)(5)(A) or (D) of the MMPA and the regulations governing the taking and importing of marine mammals (50 CFR part 216); and (2) in accordance with 40 CFR 1505.2, to announce and explain the basis for NMFS' decision to review and potentially issue incidental take authorizations under the MMPA on a case-by-case basis, if appropriate.
The Council on Environmental Quality (CEQ) regulations state that “[a]gencies shall prepare supplements to either draft or final environmental impact statements if: (i) the agency makes substantial changes in the proposed action that are relevant to environmental concerns; or (ii) there are significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts.” (40 CFR 1502.09(c)). In addition, NMFS has considered CEQ's “significance” criteria at 40 CFR 1508.27 and the criteria relied upon for the 2020 ROD to determine whether any new circumstances or information are “significant,” thereby requiring supplementation of the 2017 PEIS.
For this proposed action, NMFS has reevaluated its findings related to the MMPA negligible impact standard and the least practicable adverse impact standard governing its regulations in light of the corrected take estimates and other relevant new information. Based on that evaluation, NMFS preliminarily reaffirms its negligible impact determinations and preliminarily finds that the corrected and additional data do not result in the need for revised mitigation and monitoring measures under the least practicable adverse impact standard.
NMFS also considered whether there are any significant new circumstances or information that are relevant to environmental concerns and have a bearing on this proposed action or its impacts. For our consideration of new circumstances and information, we consulted scientific publications from 2021-22, data that were collected by the agency and other entities after the PEIS was completed, field reports, and other sources (
This proposed rule provides analysis of the same activities and activity levels considered for the 2021 final rule for the same original five-year period of time and utilizes the same modeling methodology described in the 2021 final rule. We incorporate the best available information, including consideration of specific new information that has become available since the 2021 rule was published and updates to currently available marine mammal density information. This proposed rule also incorporates expanded modeling results that estimate take utilizing the existing methodology but also consider the effects of using smaller (relative to the proxy source originally defined by BOEM) airgun arrays currently prevalent, as evidenced by LOA applications received by NMFS to date (see
There are no changes to the nature or level of the specified activities within or across years or to the geographic scope of the activity. Based on our preliminary assessment of the specified activity in light of the revised take estimates and other new information, we have determined that the 2021 regulations at 50 CFR 217.180, including the required mitigation and associated monitoring measures, satisfy the MMPA requirement to prescribe the means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, and therefore, do not propose to change those regulations, nor do we propose to change the requirements pertaining to monitoring and reporting. This rulemaking supplements the information supporting the 2021 incidental take rule. This proposed rule would not change the existing expiration date of the 2021 regulations (April 19, 2026). In addition, NMFS' demarcation of “years” under the 2021 final rule for purposes of accounting for authorized take (
As to the negligible impact findings, the revised take numbers remain within those previously analyzed for most species. (Take numbers increased compared with the 2021 final rule for four species: Rice's whale, Fraser's dolphin, rough-toothed dolphin, and striped dolphin. See Tables 5 and 6. Because of the new category of blackfish, there is uncertainty on any change in the take numbers for the individual species that comprise that category, though collectively the take numbers for all species in the blackfish category remain within the levels previously analyzed.) However, we revisited the risk assessment framework used in the 2021 analyses for all species, as elements of the framework are dependent on information related to stock abundance, which has been updated. For most species, we provide updated negligible impact analyses and determinations. For those species for which take numbers decreased and associated evaluated risk remained static or declined, we incorporate (by either repeating, summarizing, or referencing) applicable information and analyses in the prior rulemaking and supporting documents. For those species, there is no other new information suggesting that the effect of the anticipated take might exceed what was considered in the 2021 final rule. Therefore, the analyses and findings included in the documents provided and produced in support of the 2021 final rule remain current and applicable. Please see the Negligible Impact Analysis and Determinations section for further information. As to the small numbers standard, we do not propose to change the interpretation and implementation as laid out in the 2021 final rule.
The specified activity for this proposed action is unchanged from the specified activity considered for the 2021 ITR, consisting of geophysical surveys conducted for a variety of reasons. BOEM's 2016 petition described a 10-year period of geophysical survey activity and provided estimates of the amount of effort by survey type and location. BOEM's 2020 update to the scope of activity included revisions to these level-of-effort projections, including limiting the projections to 5 years and removing activity assumed to occur within the areas removed from the
Geophysical surveys in the GOM are typically conducted in support of hydrocarbon exploration, development, and production by companies that provide such services to the oil and gas industry. Broadly, these surveys include deep penetration surveys using large airgun arrays as the acoustic source; shallow penetration surveys using a small airgun array, single airgun, or other systems that may achieve similar objectives (here considered broadly as including boomers and sparkers) as the acoustic source; or high-resolution surveys, which may use a variety of acoustic sources. Geophysical surveys and associated acoustic sources were described in detail in NMFS' 2018 notice of proposed rulemaking and in the notice of issuance for the 2021 final rule. Please see those notices for detailed discussion of geophysical survey operations, associated acoustic sources, and the specific sources and survey types that were the subject of acoustic exposure modeling. Information provided therein remains accurate and relevant and is not repeated here. The use of these acoustic sources produces underwater sound at levels that have the potential to result in harassment of marine mammals. Marine mammal species with the potential to be present in the GOM are described below (see Table 2).
Generally speaking, survey activity projected by BOEM may occur within Federal territorial waters and waters of the U.S. Exclusive Economic Zone (EEZ) (
The dates and duration of the specified activities considered for this proposed rule are unchanged from the dates and duration for the 2021 final rule, which may occur at any time during the period of validity of the regulations (April 19, 2021, through April 18, 2026).
The specified geographical region for this proposed action is unchanged from the one considered for the 2021 final rule. The OCS planning areas are depicted in Figure 1, and the overlap of the former GOMESA moratorium area, which is now withdrawn from leasing consideration, with the geographical region (as well as with the modeling zones) is depicted in Figure 2. NMFS provided a detailed discussion of the specified geographical region in the 2018 notice of proposed rulemaking.
The 2021 final rule allows for the authorization of take, through LOAs, incidental to airguns of different sizes and configurations. The supporting modeling considered two specific airgun array sizes/configurations (as well as a single airgun). For this proposed rule, modeling of a third representative airgun size is also specifically considered. Acoustic exposure modeling performed in support of the 2021 rule was described in detail in “Acoustic Propagation and Marine Mammal Exposure Modeling of Geological and Geophysical Sources in the Gulf of Mexico” and “Addendum to Acoustic Propagation and Marine Mammal Exposure Modeling of Geological and Geophysical Sources in the Gulf of Mexico” (Zeddies
Representative sources for the modeling include three different airgun arrays, a single airgun, and an acoustic source package including a CHIRP sub-bottom profiler in combination with multibeam echosounder and side-scan sonar. Two major survey types were considered: large-area (including 2D, 3D narrow azimuth (NAZ), 3D wide azimuth (WAZ), and coil surveys) and small-area (including single airgun surveys and high-resolution surveys; the single airgun was used as a conservative proxy for surveys using a boomer or sparker). The nominal airgun sources used for analysis of the specified activity include a single airgun (90-in
While it was necessary to identify representative sources for the purposes of modeling take estimates for the analysis for the 2021 rule, the analysis is intended to be, and is appropriately, applicable to takes resulting from the use of other sizes or configurations of airguns (
While these descriptions reflect existing technologies and current practice, new technologies and/or uses of existing technologies may come into practice during the remaining period of validity of these regulations. As stated in the 2021 final rule, NMFS will evaluate any such developments on a case-specific basis to determine whether
As noted above, estimated levels of effort are unchanged from those considered in the 2021 final rule. Please see the 2021 final rule notice for additional detailed discussion of those estimates and of the approach to delineating modeling zones (shown in Figure 2).
In support of its 2020 revision of the scope of the rule, BOEM provided NMFS with revised 5-year level of effort predictions and associated acoustic exposure estimates. Table 1 provides those effort projections for the 5-year period, which are unchanged.
The preceding description of the specified activity is a summary of critical information. The interested reader should refer to the 2018 notice of proposed rulemaking (83 FR 29212, June 22, 2018), as well as BOEM's petition (with recent addenda) and PEIS, for additional detail regarding these activities and the region. Required mitigation, monitoring, and reporting measures are described later in this document (see Proposed Mitigation and Proposed Monitoring and Reporting).
Table 2 lists all species with expected potential for occurrence in the GOM and summarizes information related to the population or stock, including potential biological removal (PBR). PBR, defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population, is considered in concert with known sources of ongoing anthropogenic mortality (as described in NMFS' SARs). For status of species, we provide information regarding U.S. regulatory status under the MMPA and Endangered Species Act (ESA). The affected species and stocks have not changed from those described in the notice of issuance of the 2021 rule. We incorporate information newly available since that rule, including updated information from NMFS' SARs, but do not otherwise repeat discussion provided in either the 2018 notice of proposed rulemaking or 2021 notice of issuance of the final rule.
In some cases, species are treated as guilds (as was the case for the analysis conducted in support of the 2021 ITR). In general ecological terms, a guild is a group of species that have similar requirements and play a similar role within a community. However, for purposes of stock assessment or abundance prediction, certain species may be treated together as a guild because they are difficult to distinguish visually and many observations are ambiguous. For example, NMFS' GOM SARs assess stocks of
The use of guilds in the 2021 final rule followed the best available density information at the time (
Twenty-one species (with 24 managed stocks) have the potential to co-occur with the prospective survey activities. For detailed discussion of these species, please see the 2018 notice of proposed rulemaking. In addition, the West Indian manatee (
All values presented in Table 2 are the most recent available at the time the analyses for this notice were completed, including information presented in NMFS' 2021 SARs (the most recent SARs available at the time of publication) (Hayes
In Table 2 above, we report two sets of abundance estimates: those from NMFS' SARs and those predicted by habitat-based cetacean density models. Please see footnote 3 of Table 2 for more detail. NMFS' SAR estimates are typically generated from the most recent shipboard and/or aerial surveys conducted. GOM oceanography is dynamic, and the spatial scale of the GOM is small relative to the ability of most cetacean species to travel. U.S. waters only comprise about 40 percent of the entire GOM, and 65 percent of GOM oceanic waters are south of the U.S. EEZ. Studies based on abundance and distribution surveys restricted to U.S. waters are unable to detect temporal shifts in distribution beyond U.S. waters that might account for any changes in abundance within U.S. waters. NMFS' SAR estimates also in some cases do not incorporate correction for detection bias. Therefore,
The model-based abundance estimates represent the output of predictive models derived from multi-year observations and associated environmental parameters and which incorporate corrections for detection bias (the same models and data from which the density estimates are derived). Incorporating more data over multiple years of observation can yield different results in either direction, as the result is not as readily influenced by fine-scale shifts in species habitat preferences or by the absence of a species in the study area during a given year. NMFS' SAR abundance estimates show substantial year-to-year variability in some cases. Incorporation of correction for detection bias should systematically result in greater abundance predictions. For these reasons, the model-based estimates are generally more realistic and, for these purposes, represent the best available information. Specifically, for assessing estimated exposures relative to abundance—used in this case to understand the scale of the predicted takes compared to the population—NMFS generally believes that the model-based abundance predictions are most appropriate because they were used to generate the exposure estimates and therefore, provide the most relevant comparison.
As discussed in footnote 3 of Table 2, NMFS' 2021 final rule provided take estimates separately for the melon-headed whale, false killer whale, pygmy killer whale, and killer whale. This proposed rule provides a single take estimate for those four species grouped together as the “blackfish.” This approach was dictated by the best available science. The model authors determined it necessary to aggregate the few sightings data available for each of the four species with sightings data that could not be resolved to the species level in order to develop a density model, as there were not sufficient confirmed sightings of individual species to create individual spatial models. Further, the model authors advised that any attempt to parse the results to species would be fraught with complicated assumptions and limited data, and that there is no readily available way to do so in a scientifically defensible manner. Previous estimates (Roberts
NMFS does not have sufficient information to support apportioning those blackfish takes to species, but we note that the sum of annual average evaluated take for the four species in the 2021 final rule is 64,742, while the new annual average take estimate for blackfish (using the updated density information) is 55,441. While some may speculate that estimated take of killer whales (as part of the blackfish group) has increased relative to that evaluated in the 2021 final rule (annual average take of 52), NMFS has no specific information to support such an assumption.
NMFS' ability to issue LOAs under the 2021 rule to date has been limited specifically with regard to killer whales, because BOEM's error most severely affected killer whale take numbers. (Evaluated Rice's whale takes were similarly affected, but were generally not implicated in LOA requests based on the location of planned surveys.) Effects to killer whales from the specified activity have not presented serious concern in a negligible impact context, even considering the original take numbers evaluated in NMFS' 2018 proposed rule (annual average take of 1,160) which produced overall scenario-specific risk ratings of low to moderate. Evaluated risk is similar across the 2018 proposed rule and this proposed rule.
Further, we note that we make a conservative assumption in this rule in the application of the risk assessment framework to blackfish. Risk is a product of severity and vulnerability. While severity is based on density and abundance and is, therefore, reflective of the new density information, vulnerability is based on species-specific factors and is different for the four species. We applied the highest vulnerability score of the four to combine with the severity to get the overall risk rating for the group. Please see Negligible Impact Analysis and Determinations for additional discussion.
As part of our evaluation of the environmental baseline, which is considered as part of the negligible impact analysis, we consider any known areas of importance as marine mammal habitat (
Areas of important marine mammal habitat may include designated critical habitat for ESA-listed species (as defined by section 3 of the ESA) or other known areas not formally designated pursuant to any statute or other law. Important areas may include areas of known importance for reproduction, feeding, or migration, or areas where small and resident populations are known to occur.
As noted above in Table 2, the former GOM Bryde's whale has been described as a new species, Rice's whale (Rosel
NOAA conducted a status review of the former GOM Bryde's whale (Rosel
NMFS subsequently developed an updated description of a “core distribution area”
In context of the sparse data from which to accurately define the distribution and because many of the sightings fall on the boundary of the convex hull polygon, a buffer was added to avoid underestimating the potential range of the species. A 10-km buffer was applied to the polygon to capture the uncertainty in position and the strip width of the visual surveys. This buffer ensures that no sightings are on a boundary of the area. An additional 20-km buffer was added to account for the possible movement whales could make in any one direction from an observed sighting. This buffer was identified by examining the daily movement data from a whale tagged for 33 days in 2010 with a satellite-linked telemetry tag. Two alternative methods were used to identify the best indicator of possible daily distance traveled by a whale. First, a “daily range” of movement was estimated by calculating swim speeds (km/hr) based upon the distances (and times) between successive satellite-tag returns and multiplying that by 24 hr. These daily ranges were highly skewed, with most in the 10-30 km range when the whale remained in a relatively small area and a few large ranges when the whale was traveling northeast to southeast through the habitat. The mean of this daily range was 46 km and the median was 21 km. To reduce the influence of differences in the number of satellite positions returned on any given day, the total distance moved within each 24-hr period was summed using all satellite positions in that day. The median of this daily range was 17 km and the mean was 30 km. As the median is a better measure of central tendency than the mean of highly skewed distributions such as those seen here, 20 km was chosen as the most likely distance a given observed whale could move within a day of the detection. In combination with the 10-km buffer to account for uncertainty in whale location during the sighting, this results in the placement of a total of a 30-km buffer around the convex hull polygon based on sighting locations, producing the area depicted in Figure 3 (see Proposed Mitigation).
In NMFS' 2018 notice of proposed rulemaking (83 FR 29212, June 22, 2018), this section included a comprehensive summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat, including general background information on sound and specific discussion of potential effects to marine mammals from noise produced through use of airgun arrays. NMFS provided a description of the ways marine mammals may be affected by the same activities considered herein, including sensory impairment (permanent and temporary threshold shifts and acoustic masking), physiological responses (particularly stress responses), behavioral disturbance, or habitat effects, as well as of the potential for serious injury or mortality. The notice of issuance for the final rule (86 FR 5322, January 19, 2021) provided updates to the discussion of potential impacts, as well as significantly expanded discussion of certain issues (
The Estimated Take section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by the specified activity. The Negligible Impact Analysis and Determinations section includes an analysis of how these activities will impact marine mammals and considers the content of this section, the Estimated Take section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and from that on the affected marine mammal populations.
This section provides an estimate of the numbers and type of incidental takes that may be expected to occur under the specified activity, which informs NMFS' preliminary negligible impact determinations. Realized incidental takes would be determined by the actual levels of activity at specific times and places that occur under any issued LOAs and by the actual acoustic source used. While the methodology and modeling for estimating take remains identical to that originally described in the 2018 proposed and 2021 final rules, updated species density values have been used, and take estimates are available for three different airgun array configurations. The highest modeled value for each species is analyzed for the negligible impact analysis.
Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment). As with the 2021 final rule, harassment is the only type of take expected to result from these activities. It is unlikely that lethal takes would occur even in the absence of the mitigation and monitoring measures, and no such takes are anticipated or will be authorized.
Anticipated takes would primarily be by Level B harassment, as use of the described acoustic sources, particularly airgun arrays, is likely to disrupt behavioral patterns of marine mammals upon exposure to sound at certain levels. There is also some potential for auditory injury (Level A harassment) to result for low- and high-frequency species due to the size of the predicted auditory injury zones for those species, though none is predicted to occur for Rice's whales (the only low-frequency cetacean in the GOM). NMFS does not expect auditory injury to occur for mid-frequency species. See discussion provided in the 2018 notice of proposed rulemaking (83 FR 29212, June 22, 2018) and in responses to public comments provided in the notice of issuance for the 2021 final rule (86 FR 5322, January 19, 2021).
Below, we summarize how the take that may be authorized was estimated using acoustic thresholds, sound field modeling, and marine mammal density data. Detailed discussion of all facets of the take estimation process was provided in the 2018 notice of proposed rulemaking (83 FR 29212, June 22, 2018), which is incorporated by reference here, as it was into the 2021 final rule, as most aspects of the modeling have not changed; any aspects of the modeling that have changed are noted below and in Weirathmueller
NMFS uses acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals generally would be reasonably expected to exhibit disruption of behavioral patterns (Level B harassment) or to incur permanent threshold shift (PTS) of some degree (Level A harassment). Acoustic criteria used herein were described in detail in the preceding notices associated with this ITR; that discussion is not repeated as no changes have been made to the relevant acoustic criteria. See Tables 3 and 4.
Zeddies
All acoustic exposure modeling, including source and propagation modeling, was redone in support of the action described herein for the reasons described below. However, all aspects of the modeling (including source, propagation, and animal movement modeling) are the same as described in Zeddies
Differences from the modeling and modeling products described in previous notices associated with this ITR are limited to source and propagation modeling of the new 5,110-in
For species occurring in oceanic waters, the updated density models are based upon data collected during vessel surveys conducted in 2003-04, 2009, and 2017-18. Survey effort was generally conducted in a survey region bounded by the shelf break (approximately the 200-m isobath) to the north and the boundary of the U.S. EEZ to the south. Separate models were created for species occurring in shelf waters (Atlantic spotted dolphin and bottlenose dolphin) based on seasonal aerial surveys conducted in 2011-12 and 2017-18. Based on water depth, the shelf models were used to predict acoustic exposures for these two species in Zones 2 and 3, and the oceanic models were used to predict exposures in Zones 4-7.
As discussed above, the updated density modeling effort retains the previous approach of treating beaked whales and
Exposure estimates above Level A and Level B harassment criteria, originally developed by Zeddies
Of even greater import for mid-frequency cetaceans is that the small calculated Level A harassment zone size in conjunction with the properties of sound fields produced by arrays in the near field versus far field leads to a logical conclusion that Level A harassment is so unlikely for species in this hearing group as to be discountable. For all mid-frequency cetaceans, following evaluation of the available scientific literature regarding the auditory sensitivity of mid-frequency cetaceans and the properties of airgun array sound fields, NMFS does not expect any reasonable potential for Level A harassment to occur. This issue was addressed in detail in the response to public comments provided in NMFS' notice of issuance for the rule (86 FR 5322, January 19, 2021; see 86 FR 5354). NMFS expects the potential for Level A harassment of mid-frequency cetaceans to be discountable, even before the likely moderating effects of aversion and mitigation are considered, and NMFS does not believe that Level A harassment is a likely outcome for any mid-frequency cetacean. Therefore, the updated modeling results provided by Weirathmueller
As discussed in greater detail in the 2018 notice of proposed rulemaking (83 FR 29212, June 22, 2018), NMFS considered the possibility of incorporating quantitative adjustments within the modeling process to account for the effects of mitigation and/or aversion, as these factors would lead to a reduction in likely injurious exposure. However, these factors were ultimately not quantified in the modeling. In summary, there is too much inherent uncertainty regarding the effectiveness of detection-based mitigation to support any reasonable quantification of its effect in reducing injurious exposure, and there is too little information regarding the likely level of onset and degree of aversion to quantify this behavior in the modeling process. This does not mean that mitigation is not effective (to some degree) in avoiding incidents of Level A harassment, nor does it mean that aversion is not a meaningful real-world effect of noise exposure that should be expected to reduce the number of incidents of Level A harassment. As discussed in greater detail in responses to public comments provided in the 2021 notice of issuance for the final rule (86 FR 5322, January 19, 2021; see 86 FR 5353), there is ample evidence in the literature that aversion is one of the most common responses to noise exposure across varied species, though the onset and degree may be expected to vary across individuals and in different contexts. Therefore, NMFS incorporated a reasonable adjustment to modeled Level A harassment exposure estimates to account for aversion for low- and high-frequency species. That approach, which is retained here, assumes that an 80 percent reduction in modeled exposure estimates for Level A harassment for low- and high-frequency cetaceans is reasonable (Ellison
While processing requests for individual LOAs under the rule using the methodology for developing LOA-specific take numbers presented in the rule, NMFS discovered discrepancies between the revised total take numbers provided by BOEM when addressing its revision to the scope of activity through removal of the GOMESA area and the underlying modeling results. (Note that the underlying modeling results are in the form of 24-hr exposure estimates, specific to each species, zone, survey type, and season. These 24-hr exposure estimates can then be scaled to generate take numbers appropriate to the specific activity or, in the case of BOEM's petition for rulemaking, to the total levels of activity projected to occur across a number of years.)
NMFS contacted BOEM regarding the issue in June 2021. Following an initial discussion, BOEM determined that when it reduced its scope of specified activity by removing the GOMESA moratorium area from the proposed action, it underestimated the level of take by inadvertently factoring species density estimates into its revised exposure estimates twice. Generally, this miscalculation caused BOEM to underestimate the total predicted exposures of species from all survey activities in its revision to the incidental take rule application, most pronouncedly for those species with the lowest densities. The practical effect of this miscalculation is that the full amount of activity for which BOEM sought incidental take coverage in its application cannot be authorized under the existing incidental take rule.
In September 2021, BOEM provided corrected exposure estimates. These are available in BOEM's September 2021 “Corrected Exposure Estimates” letter, available online at:
When calculating estimated takes for the 2020 revision to the scope of activity, BOEM multiplied the modeled number of animals above threshold per day of survey (
Observing that the resultant numbers did not make sense, BOEM attempted to rectify the issue, by applying approximated species-specific scaling factors (
The result of this approach was that errors of varying degrees were introduced to the BOEM-derived take numbers evaluated in the final rule. Although NMFS was unable to replicate the derivation of the species-specific scaling factors, or to adequately compare the erroneous BOEM-derived values to the values evaluated in NMFS' 2018 proposed rule or to other published values, it remained clear that the take estimates were significantly underestimated for multiple species. Because of this, recalculation of appropriate take numbers was necessary.
As discussed previously, through NMFS' experience in implementing the 2021 final rule, it has become evident that operators are not currently using airgun arrays as large as the proxy array specified by BOEM for the original exposure modeling effort, and that the use of that 72-element, 8,000-in
Since the time of the original acoustic exposure modeling, JASCO has reviewed all species definition files and applied extensive updates for many species. These files define the species-specific parameters that control animat behavior during animal movement modeling. In particular, changes in the minimum and maximum depth preferences affected the coverage area for several species, which resulted in significant changes to some estimated exposures for some species.
In addition, at the time NMFS determined it would conduct a rulemaking to address the corrected take estimates, NMFS was aware that new cetacean density modeling (including incorporation of new Rice's whale data) was nearing completion, in association with the BOEM-funded GoMMAPPS effort (see:
Estimated instances of take,
Typically, and especially in cases where PTS is predicted, NMFS anticipates that some number of individuals may incur temporary threshold shift (TTS). However, it is not necessary to separately quantify those takes, as it is unlikely that an individual marine mammal would be exposed at the levels and duration necessary to incur TTS without also being exposed to the levels associated with behavioral disruption. As such, NMFS expects any potential TTS takes to be captured by the estimated takes by behavioral disruption (discussed below).
Differences between the estimated instances of take evaluated in the 2021 final rule (Table 5) and those evaluated herein (Table 6) may be attributed to multiple factors. Due to the confounding nature of these factors, it is challenging to attribute species-specific differences by degree to any particular factor. These factors include: (1) BOEM errors in calculating estimated take in support of its revision of scope for the 2021 final rule, which are related to species-specific density values by zone, as well as to species-specific “correction factors” developed by BOEM; (2) JASCO revisions to species definition files governing animat behavior during animal movement modeling; and (3) new density information for all species other than Fraser's dolphin and rough-toothed dolphin. In addition, for the Rice's whale, propagation modeling of a new array specification produced the greatest values for estimated instances of take. While it is difficult to attribute species-specific changes to specific factors, we do know that the correction of the BOEM error could only result in take number increases from the 2021 final rule, while density changes and species definition file changes could result in either increases or decreases in take estimates. NMFS has addressed BOEM's error to the extent possible in the discussion provided previously (see
Regarding the species characteristics used in the new modeling, as discussed above, all species behavior files were reviewed by JASCO prior to the new modeling, and many had extensive updates. In particular, changes in the minimum and maximum depth preferences affected the coverage area for several species, which resulted in changes to some species exposures.
New modeling for the smaller, 5,110-in
While the larger array did produce greater predicted exposures for all species, with the exception of Rice's whales, the differences between predicted exposure estimates for the two larger arrays was not as great as may have been expected on the basis of total
NMFS cautions against interpretation of the changes presented in Table 7 at face value for a variety of reasons. First, reasons for the differences are difficult to interpret, as discussed in detail in the foregoing. Second, the meaning of the differences in terms of impacts to the affected species or stocks is similarly not as straightforward as may be indicated by the magnitude and direction of the differences. Differences in estimated take are, in part, the result of the introduction of new density data, which also provides new model-predicted abundance estimates. Our evaluation under the MMPA of the expected impacts of the predicted take events is substantially reliant on comparisons of the expected take to the predicted abundance. See discussion of our evaluation of severity of impact (one prong of analysis) in Negligible Impact Analysis and Determinations. The severity of the predicted taking is understood through the estimates' relationship to predicted zone-specific abundance values, and so the absolute differences presented in Table 7 are not alone informative in that regard.
Overall, NMFS has determined, to the extent possible, that aside from the confounding effect of BOEM's calculation errors, differences between the current and prior results for the 8,000-in
NMFS has determined the values shown in Table 6 are a reasonable estimate of the maximum potential instances of take that may occur in each year of the regulations (more specifically, each of these “takes” representing a day in which one individual is exposed above the Level B harassment criteria, even if only for minutes). However, these take numbers do not represent the number of individuals expected to be taken, as they do not consider the fact that certain individuals may be exposed above harassment thresholds on multiple days. Accordingly, as described in the 2018 notice of proposed rulemaking, NMFS developed an approach to inform two important parts of the analyses, both better understanding a closer approximation of the number of individuals of each species or stock that may be taken within a survey, and understanding the degree to which individuals of each species or stock may be more likely to be repeatedly taken across multiple days within a year.
In summary, comparing the results of modeling simulations that more closely match longer survey durations (30 days) to the results of 24-hour take estimates scaled up to 30 days (as the instances of take in Table 6 were calculated) provides the comparative ratios of the numbers of individuals taken/calculated (within a 30-day survey) to instances of take, in order to better understand the comparative distribution of exposures across individuals of different species. These products are used to inform a better understanding of the nature in which individuals are taken across the multiple days of a longer duration survey given the different behaviors that are represented in the animat modeling and may appropriately be used in combination with the calculated instances of take to predict the number of individuals taken for surveys of similar duration, in order to support evaluation of take estimates in requests for Letters of Authorization under the “small numbers” standard, which is based on the number of individuals taken. A detailed discussion of this approach was provided in the 2018 notice of proposed rulemaking. As NMFS retains without change this “scalar ratio” approach to approximating the number of individuals taken, both here (see
These adjusted take numbers, representing a closer approximation of the number of individuals taken (shown in Table 8), provide a more realistic basis upon which to evaluate severity of the expected taking. Please see the Negligible Impact Analysis and Determinations section, later in this document, for additional detail. It is important to recognize that while these scaled numbers better reflect the number of individuals likely to be taken within a single 30-day survey than the number of instances in Table 6, they will still overestimate the number of individuals taken across the aggregated GOM activities, because they do not correct for (
As noted in the beginning of this section and in the Small Numbers section, using modeled instances of take (Table 6) and the method used here to scale those numbers allows one to more accurately predict the number of individuals that will be taken as a result of exposure to one survey and, therefore, these scaled predictions should be considered in requests for LOAs to assess whether a resulting LOA would meet the small numbers standard. However, for the purposes of ensuring that the take authorized pursuant to all issued LOAs is within the scope of the analysis conducted to support the negligible impact finding in this rule, authorized instances of take (which are the building blocks of the analysis) also must be assessed. Specifically, reflecting Table 6 and what has been analyzed, the total take authorized for any given species or stock over the course of the five years covered under these regulations should not exceed the sum of the five years of take indicated for the five years in that table. Additionally, in any given year, the take of any species should not exceed the highest annual take listed for any of the five years.
Under section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for subsistence uses (hereinafter referred to as “LPAI” or “least practicable adverse impact”). NMFS does not have a regulatory definition for least practicable adverse impact. However, NMFS' implementing regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)). We note that in some cases, certain mitigation may be necessary in order to make a “negligible impact” finding for an affected species or stock, which is a fundamental requirement of issuing an authorization—in these cases, consideration of practicability may be a lower priority for decision-making if impacts to marine mammal species or stocks would not be negligible in the measure's absence. In the Mitigation section of the 2021 final rule, NMFS included a detailed description of our interpretation of the LPAI standard and how it should be applied, and we refer readers to that discussion.
In summary, in evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers two primary factors:
(1) The manner in which, and the degree to which, implementation of the potential measure(s) is expected to reduce adverse impacts to marine mammal species or stocks, their habitat, and their availability for subsistence uses (where relevant). This analysis considers such things as the nature of the potential adverse impact (such as likelihood, scope, and range), the likelihood that the measure will be effective if implemented, and the likelihood of successful implementation.
(2) The practicability of the measures for applicant implementation. Practicability of implementation may consider such things as cost, impact on
In carrying out the MMPA's mandate for this action, NMFS applies the previously described context-specific balance between the manner in which and the degree to which measures are expected to reduce impacts to the affected species or stocks and their habitat and practicability for operators. The effects of concern (
Our prior rulemaking for the 2021 final rule focused on measures with proven or reasonably presumed ability to avoid or reduce the intensity of acute exposures that have potential to result in these anticipated effects with an understanding of the drawbacks or costs of these requirements. In addition, we evaluated time-area restrictions that would avoid or reduce both acute and chronic impacts, including potential restrictions that were removed from consideration in the final rule as a result of BOEM's change to the scope of the action. To the extent of the information available to NMFS, we considered practicability concerns, as well as potential undesired consequences of the measures,
In order to satisfy the MMPA's least practicable adverse impact standard, NMFS' 2021 rule evaluated a suite of basic mitigation protocols that are required regardless of the status of a stock. Additional or enhanced protections were required for species whose stocks are in particularly poor health and/or are subject to some significant additional stressor that lessens that stock's ability to weather the effects of the specified activities without worsening its status. NMFS' evaluation process was described in detail in the original proposed rule (83 FR 29212, June 22, 2018), and mitigation requirements included in the incidental take regulations were fully described in the notice of issuance for the final rule (86 FR 5322, January 19, 2021).
For this proposed rule, NMFS considered additional mitigation for this action in light of the updated take estimates. Based on that evaluation, we have preliminarily determined that the current regulations promulgated under the 2021 final rule satisfy the least practicable adverse impact standard, and therefore, we do not propose changes to those regulations. Because the proposed mitigation requirements for this action are the same as those described in the notice of issuance for the final rule (86 FR 5322, January 19, 2021), we do not repeat the description of the required mitigation.
Below, we include additional discussion supporting the least practical adverse impact finding as it relates to Rice's whales, given the increase in estimated take relative to the 2021 final rule and other new information. For other species, despite slight increases in estimated take (for three species) and increases in evaluated risk (for other species) since the 2021 final rule (see Negligible Impact Analysis and Determinations), there are no known specific areas of particular importance to consider for time-area restrictions, and no changes to our prior analysis for the sufficiency of the existing standard operational mitigation requirements to effect the least practicable adverse impact on the affected species or stocks and their habitat. (We also note that NMFS' 2018 proposed rule made this determination even in the context of significantly higher takes, as well as evaluated risk.)
As described previously, NMFS has developed an updated description of Rice's whale core habitat area (Figure 3). The updated process for describing “core habitat” incorporated a more precautionary approach to addressing uncertainty associated with both the location of observed whales as well as to account for the possible movement whales could make in any one direction from an observed sighting,
Rice's whales form a small and resident population in the northeastern GOM, with a highly restricted geographic range and a very small population abundance—determined by the status review team to be “at or below the near-extinction population level” (Rosel
While various population abundance estimates are available (
The small population size, restricted range, and low genetic diversity alone place these whales at significant risk of extinction (IWC, 2017), which has been exacerbated by the effects of the DWH oil spill. Additionally, Rice's whale dive and foraging behavior places them at heightened risk of being struck by vessels and/or entangled in fishing gear (Soldevilla
NMFS' 2018 proposed rule proposed a seasonal restriction on survey activity in the core habitat area considered therein, but also requested comment on a range of alternatives (including a year-round restriction). That proposal, and associated alternatives, were offered for public comment in context of the significantly greater predicted take numbers evaluated in the 2018 proposed rule and the complete overlap of the original project area with the core habitat area prior to the removal of the
As noted above, the proposed restriction, and alternatives thereto, were no longer relevant due to the changed geographic scope of the 2021 final rule. We now consider the effectiveness and practicability of a potential restriction covering the approximately 5 percent of core habitat (updated) that overlaps with the geographic scope of this rule, as well as of other areas that could be considered important habitat for Rice's whales.
As discussed in the 2018 proposed rule, a restriction on (or absence of) survey activity in core habitat would be expected to protect Rice's whales and their habitat through the alleviation or minimization of a range of airgun effects, both acute and chronic, that could otherwise accrue to impact the reproduction or survival of individuals in the core habitat area. The absence of survey activity in the area would not only largely avoid Level B harassment of Rice's whales, but also very importantly minimize other acoustic effects such as masking and loss of communication space.
However, the significant concern that led NMFS to consider such a restriction through the 2018 proposed rule has largely been alleviated through the reduction in predicted take numbers. Although predicted take numbers have increased relative to the 2021 final rule (annual average Level B harassment events of 26 versus 8), expected takes remain significantly less than those considered in that 2018 analysis (annual average of 462, plus some expected potential for Level A harassment to occur)—an almost 18-fold reduction. Moreover, the functional absence of survey activity in the eastern GOM, and within Rice's whale core habitat, means that the anticipated protection afforded by the previously proposed restriction has been substantively achieved by virtue of the change in scope for the 2021 final rule (which is unchanged for this proposed action). Although the updated core habitat area now slightly overlaps with the geographic scope of the rule (5 percent of defined core habitat overlaps the area considered as part of this rule), we note that the update to the core habitat description is not the result of additional Rice's whale sightings necessitating the expanded description, but rather through the incorporation of additional precaution in defining the area within which existing Rice's whale sightings and tag locations suggest that whales could occur (
Although the core habitat area is largely no longer relevant under the updated geographic scope of the specified activity and this rule, the discussion above is still important to describe NMFS' work to identify appropriate mitigation in this rulemaking. In addition, we acknowledge that some whales are likely to be present at locations other than within the core habitat area, and we considered additional information in order to evaluate whether a different closure area may be warranted, including central and western GOM areas within the same general 100-400 m depth range known to be occupied by Rice's whales in the northeastern GOM.
Outside of the core habitat area, a NOAA survey reported observation of a Rice's whale in the western GOM in 2017 (NMFS, 2018). There had not previously been a verified sighting of a Rice's whale in the western GOM, and given the importance of this observation, additional survey effort was conducted in an attempt to increase effort in the area. However, no additional sightings were recorded. (Note that there were two sightings of unidentified large baleen whales in 1992 in the western GOM, recorded as
In addition, Soldevilla
The passive acoustic data discussed above provide evidence for the persistent occurrence of at least some individual Rice's whales over a broader distribution in the GOM than previously understood. However, overall, Rice's whale observations remain consistently located within the eastern GOM core habitat area, with few whales sighted
NMFS produced a regulatory impact analysis (RIA) in support of the 2018 proposed rule, which evaluated potential costs associated with a range of area-based activity restrictions (available online at:
Historical Rice's whale habitat, which is also generally modeled as being suitable habitat (Roberts
In summary, the foregoing preliminarily supports (1) that there is no clearly defined important habitat with known occupation and usage patterns outside the existing core habitat area that would appropriately be subject to a restriction on survey activity; and (2) the potential that a central GOM closure would have significant economic impacts. During implementation of the existing rule, NMFS has issued three LOAs in association with surveys occurring roughly within this area of the central GOM (87 FR 55790, October 1, 2022; 87 FR 43243, July 20, 2022; 87 FR 42999, July 19, 2022). Based on these surveys, there is a possibility that the closure could affect the broader contribution of the GOM to future U.S. oil and gas activity. Given the relatively low level of take predicted to occur for Rice's whales in context of the de facto protection afforded through the circumscribed scope of the rule (
NMFS has reevaluated the suite of mitigation measures required through the 2021 final regulations and considered other measures in light of the new information considered in this proposed rule. Based on our evaluation of these measures, we have preliminarily affirmed that the required mitigation measures contained in the current regulations provide the means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an LOA for an activity, section 101(a)(5)(A) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of the authorized taking. NMFS' MMPA implementing regulations further describe the information that an applicant should provide when requesting an authorization (50 CFR 216.104(a)(13)), including the means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and the level of taking or impacts on populations of marine mammals. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
We do not propose changes to the current LOA reporting requirements, which have been sufficient to date. Accordingly, the monitoring and
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
For each potential activity-related stressor, NMFS considers the potential effects to marine mammals and the likely significance of those effects to the species or stock as a whole. Potential risk due to vessel collision and related mitigation measures, as well as potential risk due to entanglement and contaminant spills, was addressed in the Proposed Mitigation and Potential Effects of the Specified Activity on Marine Mammals sections of the 2018 and 2021 notices of proposed and final rulemaking and are not discussed further, as there are minimal risks expected from these potential stressors.
The “specified activity” for this proposed rule continues to be a broad program of geophysical survey activity that could occur at any time of year in U.S. waters of the GOM, within the same specified geographical region as the 2021 final rule (
In recognition of the broad geographic and temporal scale of this activity, in support of the issuance of the 2021 rule, we applied an explicit, systematic risk assessment framework (discussed in detail in the 2018 notice of proposed rulemaking) to evaluate potential effects of aggregated discrete acoustic exposure events (
In summary, the systematic risk assessment framework uses the modeling results to put into biologically-relevant context the level of potential risk of injury and/or disturbance to marine mammals. The framework considers both the aggregation of acute effects and the broad temporal and spatial scales over which chronic effects may occur. Generally, this approach is a relativistic risk assessment that provides an interpretation of the exposure estimates within the context of key biological and population parameters (
Spectral, temporal, and spatial overlaps between survey activities and animal distribution are the primary factors that drive the type, magnitude, and severity of potential effects on marine mammals, and these considerations are integrated into both the severity and vulnerability assessments. The framework utilizes a strategic approach to balance the weight of these considerations between the two assessments, specifying and clarifying where and how the interactions between potential disturbance and species within these dimensions are evaluated. Overall ratings are then considered in conjunction with the required mitigation (and any additional relevant contextual information) to ultimately inform our determinations. Elements of this approach are subjective and relative within the context of this program of projected actions and, overall, the analysis necessarily requires the application of professional judgment.
As shown in Tables 5 and 6, estimated take numbers for most species have decreased relative to those evaluated in the notice of issuance for the 2021 final rule. We note that this includes the “blackfish” guild (consisting of the false killer whale, pygmy killer whale, melon-headed whale, and killer whale), for which species-specific take information is not available. Both the annual maximum and 5-year total take numbers for the group have decreased relative to the sum of the previous species-specific values (annual maxima and 5-year totals) evaluated in the 2021 final rule.
As elements of the risk assessment framework are dependent on information related to stock abundance, we have revisited the risk assessment methodology for all species, and present updated information below. Specifically, as discussed below, severity ratings are the product of
Estimated take numbers increased (relative to the 2021 final rule) for only four species: Rice's whale, Fraser's dolphin, rough-toothed dolphin, and striped dolphin (though it should be noted that overall relative risk ratings remained static for Rice's whale and Fraser's dolphin). Whether estimated take numbers increased for each of the four species within the “blackfish” category is unknown under NMFS' proposed approach to estimating take numbers. However, overall relative risk ratings increased slightly for most species. Of the species for which evaluated take decreased, relative risk ratings remained static (or declined) for the sperm whale, beaked whales, bottlenose dolphin, and spinner dolphin. No new information is available for these four taxa that would suggest that the existing negligible impact analyses should be revisited. Therefore, we rely on the existing negligible impact analyses for the sperm whale, all beaked whale species, bottlenose dolphin, and spinner dolphin. Please see the notice of issuance for the current rule (86 FR 5322, January 19, 2021) for analysis related to these species, which we incorporate by reference to this proposed rule. We revisit here the negligible impact analyses for those species for which evaluated take numbers increased and/or for which the assessed relative risk rating increased.
The risk assessment framework comprehensively considers the aggregate impacts to marine mammal populations from the specified activities in the context of both the severity of the impacts and the vulnerability of the affected species. However, it does not consider the effects of the mitigation required through these regulations in identifying risk ratings for the affected species. In addition, while the risk assessment framework comprehensively considers the spatial and temporal overlay of the activities and the marine mammals in the GOM, as well as the number of predicted takes, there are details about the nature of any “take” anticipated to result from these activities that were not considered directly in the framework analysis that warrant explicit consideration in the negligible impact determination. Accordingly, following the description of the framework analysis presented below, NMFS highlights a few factors regarding the nature of the predicted “takes” and then brings together the results of implementation of the framework, these additional factors, and the anticipated effects of the mitigation to summarize the negligible impact analysis for each of the species considered here. The risk assessment analysis below is performed for 2 representative years, with Year 1 representing a relatively high-effort scenario and Year 4 representing a moderate-effort scenario. Please see Table 2 for details regarding BOEM's level of effort projections.
As described above in Estimated Take, a significant model assumption was that populations of animals were reset for each 24-hr period. Exposure estimates for the 24-hr period were then aggregated across all assumed survey days as completely independent events, assuming populations turn over completely within each large zone on a daily basis. In order to evaluate modeled daily exposures and determine more realistic exposure probabilities for individuals across multiple days, we used information on species-typical movement behavior to determine a species-typical offset of modeled daily exposures, summarized under Estimated Take (and discussed in further detail in the 2021 notice of issuance for the final rule). Given that many of the evaluated survey activities occur for 30-day or longer periods, particularly some of the larger surveys for which the majority of the modeled exposures occur, using such a scaling process is appropriate in order to evaluate the likely severity of the predicted exposures and to estimate take for the purposes of LOA applications and predicting the number of individual marine mammals taken during the course of a single survey (although, for surveys significantly longer than 30 days, the take numbers with this scaling applied would still be expected to overestimate the number of individuals, given the greater degree of repeat exposures that would be expected the longer the survey goes on). This output was used in a severity assessment. This approach is also discussed in more detail in the Southall
The scaled Level B harassment takes were then rated through a population-dependent binning system, used to evaluate risk associated with behavioral disruption across species—a simple, logical means of evaluating relative risk across species and areas. See the notice of issuance for the 2021 final rule for more detail regarding the definition of relative risk ratings. Results of the reassessed severity ratings are shown in Table 10.
Level A harassment (including PTS) is not expected to occur for any of the species evaluated here, with the exception of
Vulnerability rating seeks to evaluate the relative risk of a predicted effect given species-typical and population-specific parameters (
In the final step of the framework, severity and vulnerability ratings are integrated to provide relative impact ratings of overall risk. Severity and vulnerability assessments each produce a numerical rating (1-5) corresponding with the qualitative rating (
Table 12 provides relative impact ratings by zone, and Table 13 provides GOM-wide relative impact ratings, for overall risk associated with predicted takes, for representative high and moderate effort scenarios.
In order to characterize the relative risk for each species across their entire range in the GOM, we used the median of the seven zone-specific risk ratings for each activity scenario (high and moderate effort), not counting those in which less than 0.05 percent of the GOM-wide abundance occurred (“n/a” in Table 12), to describe a GOM-wide risk rating for each of the representative activity scenarios (Table 13).
As noted above, for sperm whale, beaked whales, bottlenose dolphin, and spinner dolphin, estimated take numbers decreased and relative risk ratings remained static (or decreased) compared with the 2021 final rule. Therefore, we rely on the analysis provided in the notice of issuance for the 2021 final rule for those species, which are not discussed further here.
Overall, the results of the risk assessment show that (as expected), risk is highly correlated with effort and density. Areas where little or no survey activity is predicted to occur or areas within which few or no animals of a particular species are believed to occur generally have very low or no potential risk of negatively affecting marine mammals, as seen across activity scenarios in Zones 1-4 (no activity will occur in Zone 1, which was entirely removed from scope of the rule, and less than 2 percent of Zone 4 remains within scope of the rule). Fewer species are expected to be present in Zones 1-3, where only bottlenose and Atlantic spotted dolphins occur in meaningful numbers. (Rice's whale core habitat largely overlaps Zone 1, which is not within scope of this rule.) Areas with consistently high levels of effort (Zones 5-7) are generally predicted to have higher overall evaluated risk across all species. In Zone 7, animals are expected to be subject to less other chronic noise and non-noise stressors, which is reflected in the vulnerability scoring for that zone. Therefore, despite consistently high levels of projected effort, overall rankings for that zone are lower than for Zones 5 and 6.
A “high” level of relative risk due to behavioral disturbance was identified in Zone 5 under both scenarios for most of the species evaluated further in the following (excepting Rice's whale (both scenarios) as well as
Changes to relative risk ratings may be seen by comparing Table 13 above with Table 15 from the 2021 final rule, and changes (in numerical terms) are indicated in parentheses for each scenario. All increases to assessed relative risk represent minor changes,
Although the scores generated by the risk assessment framework and further aggregated across zones (as described above) are species-specific, additional stock-specific information is also considered in our analysis, where appropriate, as indicated in the Description of Marine Mammals in the Area of the Specified Activity, Potential Effects of the Specified Activity on Marine Mammals and Their Habitat, and Proposed Mitigation sections of the 2018 notice of proposed rulemaking, 2021 notice of issuance of the final rule, and this proposed action.
In order to more fully place the predicted amount of take into meaningful context, it is useful to understand the duration of exposure at or above a given level of received sound, as well as the likely number of repeated exposures across days. While a momentary exposure above the criteria for Level B harassment counts as an instance of take, that accounting does not make any distinction between fleeting exposures and more severe encounters in which an animal may be exposed to that received level of sound for a longer period of time. Yet, this information is meaningful to an understanding of the likely severity of the exposure, which is relevant to the negligible impact evaluation and not directly incorporated into the risk assessment framework described above. Each animat modeled has a record or time history of received levels of sound over the course of the modeled 24-hr period. For example, for the four “blackfish” species exposed to noise from 3D WAZ surveys, the 50th percentile of the cumulative distribution function indicates that the time spent exposed to levels of sound above 160 dB rms SPL (
Additionally, as we discussed in the Estimated Take section of the 2018 notice of proposed rulemaking for Test Scenario 1 (and summarized above), by comparing exposure estimates generated by multiplying 24-hr exposure estimates by the total number of survey days versus modeling for a full 30-day survey duration for six representative species, we were able to refine the exposure estimates to better reflect the number of individuals exposed above threshold within a single survey. Using this same comparison and scalar ratios described above, we are able to predict an average number of days each of the representative species modeled in the test scenario were exposed above the Level B harassment thresholds within a single survey. As with the duration of exposures discussed above, the number of repeated exposures is important to an understanding of the severity of effects. For example, the ratio for dolphins indicates that the 30-day modeling showed that approximately 29 percent as many individual dolphins (compared to the results produced by multiplying average 24-hr exposure results by the 30-day survey duration) could be expected to be exposed above harassment thresholds. However, the approach of scaling up the 24-hour exposure estimates appropriately reflects the instances of exposure above threshold (which cannot be more than 1 in 24 hours), so the inverse of the scalar ratio suggests the average number of days in the 30-day modeling period that dolphins are exposed above threshold is approximately 3.5. It is important to remember that this is an average and that it is more likely some individuals would be exposed on fewer days and some on more. Table 14 reflects the average days exposed above threshold for the indicated species having applied the scalar ratios described previously.
In general, NMFS expects that noise-induced hearing loss as a result of airgun survey activity, whether temporary (temporary threshold shift, equivalent to Level B harassment) or permanent (PTS, equivalent to Level A harassment), is only possible for low-frequency and high-frequency cetaceans. The best available scientific information indicates that low-frequency cetacean species (
Level A harassment is predicted to occur for
However, some subset of the individual marine mammals predicted to be taken by Level B harassment may incur some TTS. For Rice's whales, TTS may occur at frequencies important for communication. However, any TTS incurred would be expected to be of a relatively small degree and short duration. This is due to the low likelihood of sound source approaches of the proximity or duration necessary to cause more severe TTS, given the fact that both sound source and marine mammals are continuously moving, the anticipated effectiveness of shutdowns, and general avoidance by marine mammals of louder sources.
For these reasons, and in conjunction with the required mitigation, NMFS does not believe that Level A harassment (here, PTS) or Level B harassment in the form of TTS will play a meaningful role in the overall degree of impact experienced by marine mammal populations as a result of the projected survey activity. Further, the impacts of any TTS incurred are addressed through the broader analysis of Level B harassment.
Potential impacts to marine mammal habitat, including to marine mammal prey, were discussed in detail in the 2018 notice of proposed rulemaking as well as in the 2021 notice of issuance for the final rule, including in responses to comments concerning these issues. There is no new information that changes that assessment, and we rely on the assessment provided in those documents and reiterated below.
Regarding impacts to prey species such as fish and invertebrates, NMFS' review of the available information leads to a conclusion that the most likely impact of survey activity would be temporary avoidance of an area, with a rapid return to pre-survey distribution and behavior, and minimal impacts to recruitment or survival anticipated. Therefore, the specified activities are not likely to have more than short-term adverse effects on any prey habitat or populations of prey species. Further, any impacts to prey species are not expected to result in significant or long-term consequences for individual marine mammals, or to contribute to adverse impacts on their populations.
Regarding potential impacts to acoustic habitat, NMFS provided a detailed analysis of potential cumulative and chronic effects to marine mammals (found in the Cumulative and Chronic Effects report, available online at
Implications for acoustic masking and reduced communication space resulting from noise produced by airgun surveys in the GOM are expected to be particularly heightened for animals that actively produce low-frequency sounds or whose hearing is attuned to lower frequencies (
In this section, for the species evaluated herein (
Although the Rice's whale core habitat area is not the subject of restrictions on survey activity, as the scope of the specified activity does not functionally include the area (95 percent of the updated core habitat area remains out of scope of the rule, with all confirmed sightings of Rice's whales within the core habitat area occurring in the portion outside the scope of this rule; see Figure 4), the beneficial effect for animals in the area described in the 2018 proposed rule remains the same. The absence of survey activity in the eastern GOM (see Figure 2) benefits GOM marine mammals by reducing the portion of a stock likely exposed to survey noise and avoiding impacts to certain species in areas of importance for them. Habitat areas of importance in the eastern GOM are discussed in detail in the Proposed Mitigation section of the 2018 notice of proposed rulemaking.
The risk assessment analysis, which evaluated the relative significance of the aggregated impacts of the survey activities across seven GOM zones in the context of the vulnerability of each species, concluded that the GOM-wide risk ratings for Rice's whales are low, regardless of activity scenario. We note that, although the evaluated severity of take for Rice's whales is very low in all zones where take could occur, vulnerability for the species is assessed as high in five of the six zones where the species occurs (vulnerability is assessed as moderate in Zone 3, where less than 1 percent of GOM-wide abundance is predicted to occur). When integrated through the risk framework described above, overall risk for the species is therefore assessed as low for both the high and moderate effort scenarios. The evaluated risk rating is the same as what was considered in the 2021 notice of issuance of the final rule, despite increased take numbers (see Tables 5-6). In the context of what remain relatively low predicted take numbers, the relative risk ratings for the species remain driven by the assessed vulnerability.
We further consider the likely severity of any predicted behavioral disruption of Rice's whales in the context of the likely duration of exposure above Level B harassment thresholds. Specifically, the average modeled time per day spent at received levels above 160 dB rms (where 50 percent of the exposed population is considered taken) ranges from 6.8-21.4 minutes for deep penetration survey types. The average time spent exposed to received levels between 140 and 160 dB rms (where 10 percent of the exposed population is considered taken) ranges from 55-164 minutes for 2D, 3D NAZ, and 3D WAZ surveys, and 401 minutes for coil surveys (which comprise approximately 10 percent of the total activity days).
Importantly, no survey activity will occur within the eastern GOM pursuant to this rule. Although there is new evidence of Rice's whale occurrence outside the eastern GOM from passive acoustic detections (Soldevilla
This new information does not affect the prior conclusion that the absence of survey activity in the eastern GOM is expected to benefit Rice's whales and their habitat by minimizing a range of potential effects of airgun noise, both acute and chronic, that could otherwise accrue to impact the reproduction or survival of individuals in this area, and that the absence of survey activity in the eastern GOM will minimize disturbance of the species in the place most important to them for critical behaviors such as foraging and socialization. The Roberts
As described in the preceding
NMFS has corrected the take estimates in the 2021 final rule generated by BOEM's errors, which appear to have caused a particularly large reduction in estimated take for Rice's whale. As a result, and in consideration of updated density information and other factors, the estimated take numbers for Rice's whale are increased from those considered in the 2021 final rule (see Tables 5-6). Accordingly, NMFS has re-evaluated the relative risk rating for Rice's whale (Tables 12-13), and considered other relevant information for the species. The risk ratings did not change from those assessed in the 2021 final rule, and new information considered herein does not affect the determinations previously made in that analysis.
No mortality of Rice's whales is anticipated or authorized. It is possible that Rice's whale individuals, if encountered in areas not typically considered to be Rice's whale habitat, will be impacted briefly on one or more days during a year of activity by one type of survey or another and some subset of those exposures above thresholds may be of comparatively long duration within a day. However, the significant and critical protection afforded through the absence of survey activity in the core habitat area ensures that the impacts of the expected takes from these activities are not likely to adversely affect Rice's whales through impacts on annual rates of recruitment or survival.
The risk assessment analysis, which evaluated the relative significance of the aggregated impacts of the survey activities across seven GOM zones in the context of the vulnerability of each species, concluded that the GOM-wide risk ratings for
Odontocetes echolocate to find prey, and while there are many different strategies for hunting, one common pattern, especially for deeper diving species, is to conduct multiple repeated deep dives within a feeding bout, and multiple bouts within a day, to find and catch prey. While exposures of the short durations noted above could potentially interrupt a dive or cause an individual to relocate to feed, such a short-duration interruption would be unlikely to have significant impacts on an individual's energy budget and, further, for these species and this open-ocean area, there are no specific known reasons (
As described above, no survey activity is expected within the eastern GOM. Importantly, the absence of survey activity in the area will reduce disturbance of
NMFS has analyzed the likely impacts of potential hearing impairment, including the estimated upper bounds of permanent threshold shift (Level A harassment) that could be authorized under the rule and do not expect that they would result in impacts on reproduction or survival of any individuals. As described in the previous section, the degree of injury for individuals would be expected to be mild, and the predicted PTS resulting from airgun exposure is not likely to affect echolocation performance or communication for
Of note, due to their pelagic distribution, small size, and cryptic behavior, pygmy sperm whales and dwarf sperm whales are rarely sighted during at-sea surveys and difficult to distinguish between when visually observed in the field. Accordingly, abundance estimates in NMFS SARs are recorded for
No mortality of
In consideration of the similarities in the nature and scale of impacts, we consider the GOM stocks of the following species together in this section: rough-toothed dolphin, Clymene dolphin, Atlantic spotted dolphin, pantropical spotted dolphin, striped dolphin, Fraser's dolphin, Risso's dolphin, melon-headed whale, pygmy killer whale, false killer whale, killer whale, and short-finned pilot whale. With the exception of Fraser's dolphin, rough-toothed dolphin, and striped dolphin, estimated (and allowable) take of these stocks (including both the maximum annual take and the total take over 5 years) has been reduced as compared to the 2021 final rule.
The risk assessment analysis, which evaluated the relative significance of the aggregated impacts of the survey activities across seven GOM zones in the context of the vulnerability of each species, concluded that the GOM-wide risk ratings for high and moderate effort scenarios ranged from very low to between low and moderate for these species. For the Fraser's dolphin, evaluated risk is the same as what was considered in the 2021 notice of issuance of the final rule, despite increased take numbers (see Tables 5-6).
We further considered the likely severity of any predicted behavioral disruption of the individuals of these species in the context of the likely duration of exposure above Level B harassment thresholds. Specifically, the average modeled time per day spent at received levels above 160 dB rms (where 50 percent of the exposed population is considered taken) ranges from 1.4-11.7 minutes for 2D, 3D NAZ, and 3D WAZ surveys and up to 25.7 minutes for coil surveys (which comprise less than 10 percent of the total projected activity days). The average time per day spent between 140 and 160 dB rms for individuals that are taken is from 8-58.1 minutes, with the one exception of killer whales exposed to noise from coil surveys, which average 73.6 minutes (though we note that the overall risk rating for the blackfish group, including killer whales, is low).
Odontocetes echolocate to find prey, and there are many different strategies for hunting. One common pattern for deeper-diving species is to conduct multiple repeated deep dives within a feeding bout, and multiple bouts within a day, to find and catch prey. While exposures of the shorter durations noted above could potentially interrupt a dive or cause an individual to relocate to feed, such a short-duration interruption would be unlikely to have significant impacts on an individual's energy budget and, further, for these species and this open-ocean area, there are no specific known reasons (
Of note, the Atlantic spotted dolphin can be expected to benefit (via lessening of both number and severity of takes) from the coastal waters time-area restriction developed to benefit bottlenose dolphins and several additional species can be expected to benefit from the absence of survey activity in important eastern GOM habitat.
No mortality or Level A harassment of these species is anticipated or authorized. It is likely that the majority of the individuals of these species will be impacted briefly on one or more days during a year of activity by one type of survey or another. Based on the nature of the individual exposures and takes, as well as the very low to low aggregated scale of the impacts across the GOM and considering the mitigation discussed here, the impacts of the expected takes from these activities are not likely to adversely impact the GOM stocks of any of these 12 GOM stocks of these species through adverse impacts on annual rates of recruitment or survival.
Based on the analysis contained herein, and the analysis incorporated by reference from the 2021 final rule for the other species and stocks for which take is authorized (Table 6), of the likely effects of the specified activities on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the specified activities for the 5-year period of the regulations will have a negligible impact on all affected marine mammal species and stocks.
Below for reference, we summarize how NMFS interprets and applies the small numbers standard, which is substantively unchanged from the full discussion provided in the 2018 notice of proposed rulemaking. Additional discussion was provided in the Comments and Responses section of the notice of issuance for the 2021 final rule to address specific comments, questions, or recommendations received from the public.
In summary, when quantitative take estimates of individual marine mammals are available or inferable through consideration of additional factors, and the number of animals taken is one-third or less of the best available abundance estimate for the species or stock, NMFS considers it to be of small numbers. For additional discussion, please see NMFS' notice of issuance for the 2021 final rule (86 FR 5322, January 19, 2021; see 86 FR 5363, 86 FR 5438). NMFS may also appropriately find that one or two predicted group encounters will result in small numbers of take relative to the range and distribution of a species, regardless of the estimated proportion of the abundance.
Further, our 2021 final rule also concluded that NMFS can appropriately elect to make a “small numbers” finding based on the estimated annual take in individual LOAs issued under the rule. This approach does not affect the negligible impact analysis for a rule, which is the biologically relevant inquiry and based on the total annual estimated taking for all activities the regulations will govern. NMFS determined this approach is a permissible interpretation of the relevant MMPA provisions. Making the small numbers finding based on the estimated annual take in individual LOAs allows NMFS to take advantage of the associated administrative and environmental benefits of utilizing section 101(a)(5)(A) that would be precluded in many cases if small numbers were required to be applied to the total annual taking under the regulations.
Regarding how small numbers will be evaluated under this rule, as in the 2021 final rule, up-to-date species information is available, and sophisticated models have been used to estimate take in a manner that will allow for quantitative comparison of the take of individuals versus the best available abundance estimates for the species or guilds. Specifically, while the modeling effort utilized in the rule enumerates the estimated instances of
Our 2021 final rule contained a fuller explanation of this interpretation and application of “small numbers” and explained how small numbers would be evaluated under the rule. We do not propose any changes to our treatment of the small numbers standard in this proposed rule, as the new information considered herein has no bearing on those discussions. See the “Small Numbers” section of the 2021 final rule at 86 FR 5438-5440 and responses to comments on small numbers at 86 FR 5363-5368 (January 19, 2021).
The regulations governing the take of marine mammals incidental to geophysical survey activities contain an adaptive management component. We do not propose any changes here. The comprehensive reporting requirements (see the Proposed Monitoring and Reporting section) are designed to provide NMFS with monitoring data from the previous year to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from the LOA-holders regarding practicability) on a regular (
Under this rule, NMFS plans to implement an annual adaptive management process including BOEM, the Bureau of Safety and Environmental Enforcement (BSEE), industry operators (including geophysical companies as well as exploration and production companies), and others as appropriate. Industry operators may elect to be represented in this process by their respective trade associations. NMFS, BOEM, and BSEE (
All reporting requirements have been complied with under the rule to date. NMFS has received a report compiled by industry trade associations in order to comply with the comprehensive reporting requirements. The report, which considers LOA-specific reports received during the first year of implementation of the rule, is available online at:
NMFS' MMPA implementing regulations require that applicants for incidental take authorizations describe the suggested means of coordinating research opportunities, plans, and activities relating to reducing incidental taking and evaluating its effects (50 CFR 216.104(a)(14)). Such coordination can serve as an effective supplement to the monitoring and reporting required pursuant to issued LOAs and/or incidental take regulations. NMFS expects that relevant research efforts will inform the annual adaptive management process described above, and that levels and types of research efforts will change from year to year in response to identified needs and evolutions in knowledge, emerging trends in the economy and available funding, and available scientific and technological resources. In the 2018 notice of proposed rulemaking, NMFS described examples of relevant research efforts (83 FR 29300-29301, June 22, 2018). We do not repeat that information here, but refer the reader to that notice for more information. The described efforts may not be predictive of any future levels and types of research efforts. Research occurring in locations other than the GOM may be relevant to understanding the effects of geophysical surveys on marine mammals or marine mammal populations or the effectiveness of mitigation. NMFS also refers the reader to the industry Joint Industry Program (JIP) website (
There are no relevant subsistence uses of marine mammals implicated by these actions. Therefore, as with the 2021 final rule, NMFS has determined that the total taking of affected species or stocks will not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7 of the ESA requires Federal agencies to insure that their actions are not likely to jeopardize the continued existence of endangered or threatened species or adversely modify or destroy their designated critical habitat. Federal agencies must consult with NMFS for actions that may affect such species under NMFS' jurisdiction or critical habitat designated for such species. At the conclusion of consultation, the consulting agency provides an opinion stating whether the Federal agency's action is likely to jeopardize the continued existence of ESA-listed species or destroy or adversely modify designated critical habitat.
On March 13, 2020, NMFS' Office of Protected Resources, ESA Interagency Cooperation Division, issued a Biological Opinion (BiOp) on federally regulated oil and gas program activities in the Gulf of Mexico, including NMFS' issuance of the ITR and subsequent LOAs (as well as all BOEM and Bureau of Safety and Environmental Enforcement approvals of activities
Under the incidental take regulations in effect for this specified activity, industry operators may apply for LOAs (50 CFR 217.186). We do not propose any changes to the regulations for obtaining an LOA. LOAs may be issued for any time period that does not exceed the effective period of the regulations, provided that NMFS is able to make the relevant determinations (50 CFR 217.183). Because the specified activity does not provide actual specifics of the timing, location, and survey design for activities that would be the subject of issued LOAs, such requests must include, at minimum, the information described at 50 CFR 216.104(a)(1) and (2), and should include an affirmation of intent to adhere to the mitigation, monitoring, and reporting requirements described in the regulations. The level of effort proposed by an operator would be used to develop an LOA-specific take estimate based on the results of Weirathmueller
As is the case now under the 2021 ITR, if applicants do not use the modeling provided by the rule, NMFS may publish a notice in the
Technologies continue to evolve to meet the technical, environmental, and economic challenges of oil and gas development. The use of “new and unusual technologies” (NUT),
Pursuant to the procedures established to implement Executive Order 12866, the Office of Management and Budget (OMB) determined that the 2021 final rule was economically significant. Accordingly, a regulatory impact analysis (RIA) was prepared and made available for review by the public. Following review of public comments, a final RIA was prepared and made available online at:
OMB has determined that this proposed rule is significant under section 3(f)(1) of E.O. 12866.
NMFS prepared a FRFA, as required by section 603 of the Regulatory Flexibility Act (RFA), for the regulations issued under the 2021 final rule, which we do not propose to change in this proposed rule. The FRFA described the economic effects on small entities. A copy of the full FRFA is available as Appendix B to the RIA. No changes are proposed here that would affect the findings of the FRFA, which were summarized in the notice of issuance for the 2021 final rule (86 FR 5443, January 19, 2021).
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. As discussed above, no changes are proposed through this rule that would result in additional economic effects to small entities. Because of this certification, a regulatory flexibility analysis is not required, and none has been prepared.
This proposed rule does not contain a change to a collection of information requirement for purposes of the Paperwork Reduction Act of 1995. The existing collection of information requirements would continue to apply under the following OMB Control Number(s): 0648-0151.
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
Exports, Fish, Imports, Indians, Labeling, Marine mammals, Penalties, Reporting and recordkeeping requirements, Seafood, Transportation.
As described above, because NMFS does not find that new mitigation measures are required, this proposed rule would not amend the current applicable regulations at 50 CFR part 217 subpart S (§§ 217.180 through 217.189). Thus, no amendatory instructions are necessary.