November 18, 2015 – Federal Register Recent Federal Regulation Documents

The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the Federal Register (FR) on October 26, 2015, regarding the submission to the Office of Management and Budget (OMB) of a request to renew an existing collection of information entitled, ``Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.'' This action is necessary to correct information about the number of respondents to this information collection.

The Food and Drug Administration (FDA or we) is clarifying the compliance date that we provided for certain food establishments subject to a final rule that published in the Federal Register of September 17, 2015. Among other things, that final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. We are taking this action in response to requests for clarification of the compliance date for facilities that manufacture, process, pack, or hold grade ``A'' milk or milk products and that are regulated under the National Conference on Interstate Milk Shipments (NCIMS) system.

This document contains proposed amendments to claims procedure regulations for plans providing disability benefits under the Employee Retirement Income Security Act of 1974 (ERISA). The amendments would revise and strengthen the current rules primarily by adopting certain of the new procedural protections and safeguards made applicable to group health plans by the Affordable Care Act. If adopted as final, the proposed regulation would affect plan administrators and participants and beneficiaries of plans providing disability benefits, and others who assist in the provision of these benefits, such as third-party benefits administrators and other service providers that provide benefits to participants and beneficiaries of these plans.

The Food and Drug Administration (FDA or we) is proposing to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These additional requirements for the ``gluten- free'' labeling rule 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.'' There is uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten. Thus, we propose to evaluate compliance of such fermented and hydrolyzed foods that bear a ``gluten-free'' claim with the gluten-free labeling rule 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 would need to provide adequate assurance that the food is ``gluten-free'' in compliance with the gluten-free food labeling final rule before fermentation or hydrolysis. In addition, the proposed rule would require the manufacturer of fermented or hydrolyzed 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, manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the ``gluten-free'' claim would be required to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are ``gluten-free'' in compliance with the gluten-free food labeling final rule. Finally, the proposed rule would state that we would 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.

On May 8, 2015, the Pipeline and Hazardous Materials Safety Administration, in coordination with the Federal Railroad Administration (FRA), published a final rule entitled ``Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains,'' which adopted requirements designed to reduce the consequences and, in some instances, reduce the probability of accidents involving trains transporting large quantities of Class 3 flammable liquids. The Hazardous Materials Regulations provide a person the opportunity to appeal a PHMSA action, including a final rule. PHMSA received six appeals regarding the final rule, one of which was withdrawn. This document responds to the five remaining appeals submitted by the Dangerous Goods Advisory Council (DGAC), American Chemistry Council (ACC), Association of American Railroads (AAR), American Fuel & Petrochemical Manufacturers (AFPM), and jointly the Umatilla, Yakama, Warm Springs, and Nez Perce tribes (Columbia River Treaty Tribes) and the Quinault Indian Nation (Northwest Treaty Tribes).

This document contains the changes to the regulations governing the administration of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA or Act), being proposed by the Department of Labor (Department or DOL). Part B of the Act provides uniform lump-sum payments and medical benefits to covered employees and, where applicable, to survivors of such employees, of the Department of Energy (DOE), its predecessor agencies and certain of its vendors, contractors and subcontractors. Part B of the Act also provides smaller uniform lump-sum payments and medical benefits to individuals found eligible by the Department of Justice (DOJ) for benefits under section 5 of the Radiation Exposure Compensation Act (RECA) and, where applicable, to their survivors. Part E of the Act provides variable lump-sum payments (based on a worker's permanent impairment and/or qualifying calendar years of established wage-loss) and medical benefits for covered DOE contractor employees and, where applicable, provides variable lump-sum payments to survivors of such employees (based on a worker's death due to a covered illness and any qualifying calendar years of established wage-loss). Part E of the Act also provides these same payments and benefits to uranium miners, millers and ore transporters covered by section 5 of RECA and, where applicable, to survivors of such employees. The Office of Workers' Compensation Programs (OWCP) administers the adjudication of claims and the payment of benefits under EEOICPA, with National Institute for Occupational Safety and Health (NIOSH) within the Department of Health and Human Services (HHS) estimating the amounts of radiation received by employees alleged to have sustained cancer as a result of such exposure and establishing guidelines to be followed by OWCP in determining whether such cancers are at least as likely as not related to employment. Both DOE and DOJ are responsible for notifying potential claimants and for submitting evidence necessary for OWCP's adjudication of claims under EEOICPA.