April 12, 2019 – Federal Register Recent Federal Regulation Documents

The Environmental Protection Agency (EPA) is approving the Ohio Environmental Protection Agency's (Ohio) request to redesignate the Cleveland area to attainment of the 2012 annual national ambient air quality standard (NAAQS or standards) for fine particulate matter (PM2.5) under the Clean Air Act (CAA).

The Environmental Protection Agency (EPA) is proposing to approve a request submitted by the Ohio Environmental Protection Agency (Ohio EPA) on January 24, 2018, to revise the Ohio State Implementation Plan (SIP) under the Clean Air Act (CAA). Ohio EPA is requesting to remove provisions under Ohio Administrative Code (OAC) Chapter 3745-75, that were approved into the Ohio SIP as part of Ohio's Hospital/ Medical/Infectious Waste Incinerator (HMIWI) state plan under sections 110(d) and 129 of the Clean Air Act. In a separate action, EPA has approved Ohio EPA's request for withdrawal of its HMIWI state plan that allows the state rules to be superseded by the Federal Plan under 40 CFR part 62, subpart HHH.

The U.S. Nuclear Regulatory Commission (NRC) is requesting comments on a draft regulatory basis to support a proposed rule that would harmonize the NRC's regulations with the safety requirements of the International Atomic Energy Agency (IAEA) for the transport of radioactive material and the regulations of the U.S. Department of Transportation (DOT). In addition, the proposed rule would make administrative, editorial, or clarification changes to the NRC's regulations. The NRC plans to hold a public meeting to discuss the draft regulatory basis and facilitate public participation.

The Environmental Protection Agency (EPA) is taking final action to approve revisions to the State Implementation Plan (SIP), and Operating Permits Program for the State of Nebraska as submitted on August 22, 2018. This action adopts the 2015 primary and secondary National Ambient Air Quality Standards for Ozone, published in the Federal Register on October 26, 2015. The EPA is also taking final action to approve revisions which are administrative in nature. These revisions include updating a reference to EPA's regulation used in the definition of ``Global Warming Potentials'', removing ``Greenhouse Gases'' from the definition of ``Regulated Air Pollutant'', and updating a reference to EPA's regulations used in the definition of ``Volatile Organic Compound''. Other typographical and reformatting revisions are also being made. Approval of these revisions will not impact air quality, ensures consistency between the State and Federally-approved rules, and ensures Federal enforceability of the State's rules.

The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.

The U.S. Nuclear Regulatory Commission (NRC) is correcting a document that published in the Federal Register (FR) on April 3, 2019, regarding the availability of a regulatory basis to support a rulemaking that would amend the NRC's regulations for the light-water power reactor vessel material surveillance programs. This action is necessary to correct the ADAMS accession number for the regulatory basis.

This regulation establishes an exemption from the requirement of a tolerance for residues of polyvinyl acetatepolyvinyl alcohol copolymer; when used as an inert ingredient in a pesticide chemical formulation. Keller and Heckman LLP. on behalf of Synthomer USA LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of polyvinyl acetatepolyvinyl alcohol copolymer on food or feed commodities.

On April 1, 2019, the Department of Veterans Affairs (VA) published a rule to amend its regulations governing the submission and processing of requests for information under the Freedom of Information Act (FOIA) and the Privacy Act to reorganize, streamline, and clarify existing regulations. An error occurred in one amendatory instruction. This document corrects that error.

The Coast Guard is establishing a temporary safety zone for certain waters of the Laguna Madre in support of the 2019 Wings over South Texas Air Show. This action is necessary to protect personnel, vessels, and the marine environment from potential hazards during aerobatic maneuvers by high-speed, low-flying airplanes and any navigation hazards associated with the set up within certain waters of Laguna Madre. This action will prohibit persons and vessels from entering the zone unless authorized by the Captain of the Port Corpus Christi (COTP) or a designated representative.

We are adopting a new airworthiness directive (AD) for certain Robinson Helicopter Company (Robinson Helicopter) Model R66 helicopters. This AD requires inspecting the oil tank outlet's fitting color. If the fitting is blue, this AD requires replacing the tank with an oil tank that lacks a blue fitting. This AD also requires determining the revision letter on the ink stamp, and installing an oil tank angle based on that determination. This AD was prompted by reports of broken oil tank internal baffles. The actions of this AD are intended to correct an unsafe condition on these products.

The Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Stationary Combustion Turbines to address the results of the residual risk and technology review (RTR) the EPA is required to conduct in accordance with the Clean Air Act (CAA). The EPA is proposing to find that the risks from this source category due to emissions of air toxics are acceptable and that the existing NESHAP provides an ample margin of safety to protect public health. The EPA identified no new cost-effective controls under the technology review that would achieve further emissions reductions from the source category. The EPA is also proposing to amend provisions addressing periods of startup, shutdown, and malfunction (SSM) and to require electronic reporting. In addition, the EPA is proposing to remove the stay of the effectiveness of the standards for new lean premix and diffusion flame gas-fired turbines that was promulgated in 2004.

The Food and Drug Administration (FDA, the Agency, or we) is issuing this final action establishing that certain active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are not eligible for evaluation under the OTC Drug Review for use in consumer antiseptic rubs. Drug products containing these ineligible active ingredients will require approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. FDA is issuing this final action after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC), public comments on the Agency's notices of proposed rulemaking, and all data and information on OTC consumer antiseptic rub products that have come to the Agency's attention. This final action finalizes the 1994 tentative final monograph (TFM) for OTC consumer antiseptic rub drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM), as amended by the proposed rule published in the Federal Register (FR) of June 30, 2016 (2016 Consumer Antiseptic Rub proposed rule).