December 24, 2013 – Federal Register Recent Federal Regulation Documents

On January 16, 2013, the Food and Drug Administration (FDA) announced the availability of, and requested comment on, a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA). FDA is now announcing the availability of, and requesting comment on, a document entitled ``Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA Appendix). The purpose of the draft RA Appendix is to provide a science-based risk analysis of those foods whose production would be considered low risk with respect to the risk of intentional adulteration caused by acts of terrorism. The appendix supplements the science-based risk analysis already included in the draft RA, which does not consider the risk of intentional adulteration caused by acts of terrorism. FDA conducted this evaluation to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.

The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss the proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. FDA is proposing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to inform the public of the provisions of the proposed rule and the rulemaking process (including how to submit comments, data, and other information to the rulemaking docket) as well as solicit oral stakeholder and public comments on the proposed rule and to respond to questions about the rule.

Upon application from the U.S. Navy (Navy), we (the National Marine Fisheries Service) are issuing regulations under the Marine Mammal Protection Act (MMPA) to govern the unintentional taking of marine mammals incidental to training and testing activities conducted in the Hawaii-Southern California Training and Testing (HSTT) Study Area from December 2013 through December 2018. These regulations allow us to issue Letters of Authorization (LOAs) for the incidental take of marine mammals during the Navy's specified activities and timeframes, set forth the permissible methods of taking, set forth other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, and set forth requirements pertaining to the monitoring and reporting of the incidental take.

The Department of Justice (the Department or DOJ) published a final rule in the Federal Register on November 21, 2013, which added a new section to the Department's Privacy Act exemption regulations to exempt two OCDETF systems of records from certain subsections of the Privacy Act. The final text of the rule incorrectly referred to exempted ``subsections'' of the Privacy Act as ``paragraphs'' of the new section. This document corrects the final rule by revising the new section.

EPA is seeking comment on options for adjusting the allowance system controlling United States consumption and production of hydrochlorofluorocarbons (HCFCs). Under Title VI of the Clean Air Act, EPA is required to phase out production and import of these chemicals in accordance with United States obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol). Under the Protocol and the Clean Air Act, total United States HCFC production and consumption is capped, and will be completely phased out by 2030. Beginning January 1, 2015, United States production and consumption of all HCFCs must be no more than ten percent of the established cap. Existing EPA regulations prohibit production and consumption of HCFC-22 and HCFC-142b as of January 1, 2020. At that time, all other HCFC production and consumption must not exceed 0.5 percent of the cap, and is limited to use as a refrigerant in existing air conditioning and refrigeration equipment. Given these requirements, EPA is seeking comment on how best to implement the 2015 stepdown to no more than 10 percent of the cap. Since the beginning of the HCFC phaseout program, the agency has tried to ensure a smooth transition out of HCFCs into non-ozone depleting alternatives. Essential to a smooth transition are the recycling and emissions reductions requirements mandated by section 608 of the Clean Air Act. This proposal also includes a request for comment on potential changes to regulations promulgated under that authority, found in 40 CFR part 82 subpart F. In addition to taking comment on the implementation of phaseout requirements and proposed changes to section 608 regulations, the agency is also highlighting important Clean Air Act requirements that take effect in 2015, specifically the section 611 labeling requirements and the section 605 restrictions on HCFC use and introduction into interstate commerce.