August 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as ``gluten- free.'' Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a ``gluten-free'' claim based on records that are made and kept by the manufacturer of the food bearing the ``gluten-free'' claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are ``gluten-free'' before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the ``gluten-free'' claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of foods bearing the ``gluten- free'' claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the ``gluten-free'' claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.

This regulation establishes and modifies tolerances for residues of novaluron in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances and modifications under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The Federal Housing Finance Agency (FHFA) is proposing a rule and seeking comments on proposed benchmark levels for the 2021 housing goals for Fannie Mae and Freddie Mac (the Enterprises). The housing goals apply to mortgages purchased by the Enterprises and include separate categories for single-family and multifamily housing that is affordable to low-income and very low-income families, among other categories. This proposed rule would establish benchmark levels for each of the housing goals for 2021.

The Energy Policy and Conservation Act, as amended (``EPCA''), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential clothes washers and consumer clothes dryers. In this notice of proposed rulemaking (``NOPR''), the Department of Energy (DOE) proposes to establish separate product classes for top-loading residential clothes washers and consumer clothes dryers that offer cycle times for a normal cycle of less than 30 minutes, and for front-loading residential clothes washers that offer cycle times for a normal cycle of less than 45 minutes. DOE would consider appropriate energy and water efficiency standards for such product classes, if adopted, in separate rulemakings.

Pursuant to its authority under Title VII of the Tariff Act of 1930, as amended (the Act), the Department of Commerce (Commerce) proposes to modify its regulations under Part 351 of Title 19 to improve administration and enforcement of the antidumping duty (AD) and countervailing duty (CVD) laws. Specifically, Commerce proposes to modify its regulation concerning the time for submission of comments pertaining to industry support in AD and CVD proceedings; to modify its regulation regarding new shipper reviews; to modify its regulation concerning scope matters in AD and CVD proceedings; to promulgate a new regulation concerning circumvention of AD and CVD orders; to promulgate a new regulation concerning covered merchandise referrals received from U.S. Customs and Border Protection (CBP); to promulgate a new regulation pertaining to Commerce requests for certifications from interested parties to establish whether merchandise is subject to an AD or CVD order; and to modify its regulation regarding importer reimbursement certifications filed with CBP. Finally, Commerce proposes to modify its regulations regarding letters of appearance in AD and CVD proceedings and importer filing requirements for access to business proprietary information. Commerce is seeking public comments on this proposed rule.

The Mid-Atlantic Fishery Management Council has submitted to NMFS Amendment 21 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan. Amendment 21 proposes revisions to the summer flounder commercial state quota allocation percentages and the fishery management plan goals and objectives. Amendment 21 is intended to increase equity in state allocations when annual coastwide commercial quotas are at or above historical averages, while recognizing the economic reliance coastal communities have on the state allocation percentages currently in place.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2021 based on our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this proposed rule would establish and update the Overall Hospital Quality Star Rating beginning with the CY 2021; remove certain restrictions on the expansion of physician-owned hospitals that qualify as ``high Medicaid facilities,'' and clarify that certain beds are counted toward a hospital's baseline number of operating rooms, procedure rooms, and beds; and add two new service categories to the OPD Prior Authorization Process.

This regulation establishes tolerances for residues of pethoxamid in or on multiple commodities which are identified and discussed later in this document. FMC Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This document contains corrections to final regulations Treasury Decision 9896 that were published in the Federal Register on Wednesday, April 8, 2020. The final regulations providing guidance regarding hybrid dividends and certain amounts paid or accrued pursuant to hybrid arrangements, which generally involve arrangements whereby U.S. and foreign tax law classify a transaction or entity differently for tax purposes.

Pursuant to the federal Clean Air Act (CAA or Act), the Environmental Protection Agency (EPA) is finalizing its affirmation, with amendments, of an intrastate sulfur dioxide (SO2) trading program as an alternative to best available retrofit technology (BART) requirements for certain sources in Texas. This action finalizes the August 2018 proposed affirmation and November 2019 supplemental notice of proposed rulemaking (SNPRM) concerning certain aspects of a final rule published on October 17, 2017, partially approving the 2009 Texas Regional Haze State Implementation Plan (SIP) submission and promulgating a Federal Implementation Plan (FIP) for Texas to address certain outstanding CAA regional haze requirements for the first implementation period.

NMFS is prohibiting directed fishing for dusky rockfish in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2020 total allowable catch of dusky rockfish in the West Yakutat District of the GOA.

NMFS announces that the State of New Jersey is transferring a portion of its 2020 commercial bluefish quota to the State of New York. This quota adjustment is necessary to comply with the Atlantic Bluefish Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised commercial bluefish quotas for New Jersey and New York.

NMFS is prohibiting directed fishing for Pacific ocean perch in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2020 total allowable catch of Pacific ocean perch in the West Yakutat District of the GOA.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD- 500-1A11 airplanes. This proposed AD was prompted by a report that during installation on the final assembly line, a foreign object damage (FOD) protective end cap was not removed from an extraction duct of the crew oxygen system. The protective end cap must be removed to prevent a build-up of oxygen under the flight deck floor, which is a fire risk. This proposed AD would require inspecting the air extraction duct installation to determine if a protective end cap is installed, and removing any protective end cap found. The FAA is proposing this AD to address the unsafe condition on these products.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is issuing this final rule to make technical amendments to the definition of ``applicable schedule amount'' in its regulations. In recent years, OFAC has adjusted its civil monetary penalties (CMPs) as required by the Federal Civil Penalties Inflation Adjustment Act, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. While OFAC's ``applicable schedule amount'' values are not civil monetary penalties that are required to be adjusted pursuant to such statute, OFAC is making technical changes to this definition to ensure the applicable schedule amount values continue to correspond appropriately to OFAC's CMPs.

The FAA proposes to adopt a new airworthiness directive (AD) for all Rolls-Royce Corporation (RRC) AE 2100A, AE 2100D2, AE 2100D2A, and AE 2100P model turboprop engines. This proposed AD was prompted by a report of a propeller gearbox (PGB) development test conducted by the manufacturer, in which high vibration occurred due to a fatigue crack that initiated in the PGB shaft and carrier assembly. This proposed AD would require assignment of usage hours to the PGB shaft and carrier assembly at the next engine shop visit and replacement of PGB shaft and carrier assemblies prior to exceeding the new life limits established by the manufacturer. The FAA is proposing this AD to address the unsafe condition on these products.

This document contains a correction to a notice of proposed rulemaking that was published in the Federal Register on April 8, 2020. The proposed regulations that adjust hybrid deduction accounts to take into account earnings and profits of a controlled foreign corporation that are included in income by a United States shareholder.

The Coast Guard is establishing a temporary special local regulation for certain waters of the North Atlantic Ocean adjacent to Ocean City, MD. This action is necessary to provide for the safety of life on these navigable waters located at Ocean City, MD, during activities associated with an air show event from August 13, 2020, through August 16, 2020. This rule prohibits persons and vessels from entering the regulated area unless authorized by the Captain of the Port Maryland-National Capital Region or the Coast Guard Patrol Commander.

NMFS closes the Harpoon category fishery for large medium and giant (i.e., measuring 73 inches (185 cm) curved fork length or greater) Atlantic bluefin tuna (BFT) through the end of the 2020 Harpoon category fishing season. Current regulations provide that the 2021 Harpoon category season begins June 1, 2021. The intent of this closure is to prevent further overharvest of the available Harpoon category BFT quota of 76 metric tons (mt).

The FAA is correcting an airworthiness directive (AD) that published in the Federal Register. The AD applies to all Daher Aircraft Design, LLC (type certificate previously held by Quest Aircraft Design, LLC), Model KODIAK 100 airplanes. As published, the type certificate (TC) holder in the regulatory heading that identifies the AD is incorrect. This document corrects that error. In all other respects, the original document remains the same; however, for clarity, the FAA is publishing the entire rule in the Federal Register.

This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2021. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2021. This final rule adopts more recent Office of Management and Budget statistical area delineations and applies a 5 percent cap on any wage index decreases compared to FY 2020 in a budget neutral manner. This final rule also amends the IRF coverage requirements to remove the post-admission physician evaluation requirement and codifies existing documentation instructions and guidance. In addition, this final rule amends the IRF coverage requirements to allow, beginning with the second week of admission to the IRF, a non-physician practitioner who is determined by the IRF to have specialized training and experience in inpatient rehabilitation to conduct 1 of the 3 required face-to-face visits with the patient per week, provided that such duties are within the non-physician practitioner's scope of practice under applicable state law.

This rule repeals regulations concerning Special measures against Banco Delta Asia, which were issued pursuant to Section 311 of the USA PATRIOT Act (Section 311). Subsequent to the issuance of this rule, FinCEN will reassess whether BDA is presently a financial institution of primary money laundering concern and additional rulemaking is warranted. Elsewhere in this issue of the Federal Register, FinCEN is publishing a withdrawal of the finding regarding BDA, issued September 20, 2005.

The Office of Personnel Management is issuing interim regulations to assist agencies and employees responding to the National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak and for future national emergencies. The regulations provide that employees who would forfeit annual leave in excess of the maximum annual leave allowable carryover because of their work to support the nation during a national emergency will have their excess annual leave deemed to have been scheduled in advance and subject to leave restoration.

The Environmental Protection Agency (EPA) is taking final action to find that Texas has failed to submit State Implementation Plans (SIPs) to satisfy certain nonattainment area planning requirements of the Clean Air Act (CAA) for the 2010 1-hour primary Sulfur Dioxide (SO2) National Ambient Air Quality Standard (NAAQS). The purpose for the development and implementation of a nonattainment area SIP is to provide for attainment of the NAAQS as expeditiously as practicable following the designation of an area as nonattainment. This action establishes certain CAA deadlines for the EPA to impose sanctions if Texas does not submit a complete SIP for each nonattainment area addressing the outstanding requirements and for the EPA to promulgate a Federal Implementation Plan (FIP) to address any outstanding SIP requirements.

The Environmental Protection Agency (EPA) is proposing to partially approve and partially disapprove revisions to the San Diego Air Pollution Control District (SDAPCD) portion of the California State Implementation Plan (SIP). These revisions concern the District's demonstration regarding reasonably available control technology (RACT) requirements and negative declarations for the 2008 ozone national ambient air quality standards (NAAQS or ``standards'') in the San Diego ozone nonattainment area (NAA) under the jurisdiction of the SDAPCD. We are taking comments on this proposal and plan to follow with a final action.