Notifications for United States of America (932 notifications)

APHIS is advising the public of our decision to concur with the World Organization for Animal Health's (OIE) bovine spongiform encephalopathy (BSE) risk designations for 14 regions. The OIE recognizes these regions as being of negligible risk for BSE. We are taking this action based on our review of information supporting the OIE's risk designations for these regions. This notice is available in English at: https://www.regulations.gov/document?D=APHIS-2015-0055-0004. Federal Register Vol. 81, No. 154/Wednesday, 10 August 2016/pgs. 52811-52812 In accordance with that process, we published a notice in the Federal Register on 4 December 2015 (80 FR 75849, Docket No. APHIS-2015-0055), in which we announced our intent to concur with the OIE risk designations for 16 regions. The OIE recognizes these regions as being of negligible risk for BSE. We solicited comments on the notice for 60 days ending on 2 February 2016. We received two comments by that date, from a private citizen and a representative of a foreign government.

This regulation establishes tolerances for residues of cloquintocet-mexyl and its acid metabolite in or on multiple commodities which are identified and discussed later in this document when cloquintocet-mexyl is used as an inert ingredient (herbicide safener) in pesticide formulations containing the new active ingredient halauxifen-methyl (XDE-729 methyl).

This regulation establishes tolerances for residues of flonicamid in or on various commodities.

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

This regulation establishes tolerances for residues of cyprodinil in or on vegetable, tuberous and corm, subgroup 1C and potato, wet peel.

This regulation establishes a tolerance for residues of etoxazole in or on soybean seed.

The Food and Drug Administration (FDA) is reopening the comment period for the notice of filing that appeared in the Federal Register of 20 May 2016 (81 FR 31877). In the notice, FDA requested comments on a filed food additive petition (FAP 6B4815), submitted by the Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science In The Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council, proposing that it amends and/or revoke specified regulations to no longer provide for the food contact use of specified ortho-phthalates. FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. The text is available in English at https://www.gpo.gov/fdsys/pkg/FR-2016-08-08/pdf/2016-18720.pdf.

The Animal and Health Inspection Service (APHIS) is proposing to amend the regulations to allow the importation of fresh mango fruit from Viet Nam into the continental United States. As a condition of entry, fresh mango fruit from Viet Nam would be subject to a systems approach that would include orchard requirements, irradiation treatment, and port of entry inspection. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of Viet Nam with an additional declaration stating that the consignment was inspected and found free of Macrophoma mangiferae and Xanthomonas campestris pv. mangiferaeindicae. This action would allow for the importation of fresh mango fruit from Viet Nam while continuing to provide protection against the introduction of plant pests into the continental United States. Federal Register/Vol. 81, No. 150/Thursday, 4 August 2016/pgs. 51381-51383

The Animal and Health Inspection Service (APHIS) is advising the public that proposed changes to the National Poultry Improvement Plan Program Standards are available for review and comment. Federal Register/Vol. 81, No. 133/Tuesday, 12 July 2016/pgs. 45121-45122

The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products.

The Animal and Plant Health Inspection Service (APHIS) is advising the public that we have prepared a pest risk analysis that evaluates the risks associated with importation of fresh star apple fruit from Viet Nam into the continental United States. Based on the analysis, we have determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh star apple fruit from Viet Nam. We are making the pest risk analysis available to the public for review and comment. Federal Register/ Vol. 81, No. 138/ Tuesday, 19 July 2016/ Pg. 46886.

The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live sheep, goats, and certain other non-bovine ruminants, and products derived from sheep and goats, with regard to transmissible spongiform encephalopathies such as bovine spongiform encephalopathy (BSE) and scrapie. We are proposing to remove BSE-related import restrictions on sheep and goats and most of their products, and to add import restrictions related to transmissible spongiform encephalopathies for certain wild, zoological, or other non-bovine ruminant species. The conditions we are proposing for the importation of specified commodities are based on internationally accepted scientific literature and will in general align our regulations with guidelines set out in the World Organization for Animal Health's Terrestrial Animal Health Code. Federal Register/Vol. 81, No. 137 /Monday, 18 July 2016/pgs. 46619-46639.

The Food and Drug Administration is amending the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted. It is taking this action in response to a food additive petition filed by Dean Foods Company and WhiteWave Foods Company. This rule is effective 18 July 2016. The text is available at https://www.gpo.gov/fdsys/pkg/FR-2016-07-18/pdf/2016-16738.pdf.

The Animal and Plant Health Inspection Service (APHIS) is extending the comment period for a proposed rule to allow the importation of lemons from northwest Argentina into the continental United States. This action will allow interested persons additional time to prepare and submit comments. This notice is available in English at: https://www.regulations.gov/document?D=APHIS-2014-0092-0155. Federal Register/Vol. 81, No. 90/Tuesday, 10 May 2016/pgs. 28758-28764.

The Food and Drug Administration is amending its regulations for registration of food facilities that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This rule amends and updates FDA's registration regulations and is part of its implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. These amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that it can use to focus and better utilize its limited inspection resources. Text is available in English at https://www.gpo.gov/fdsys/pkg/FR-2016-07-14/pdf/2016-16531.pdf.

The Food Safety and Inspection Service (FSIS) is amending the Federal meat inspection regulations to add Namibia to the list of countries eligible to export meat and meat products to the United States. FSIS has reviewed Namibia's laws, regulations, and inspection system as implemented, and has determined that they are equivalent to the Federal Meat Inspection Act (FMIA), the regulations implementing this statute, and the United States food safety system for meat and meat products. Under this final rule, Namibia will only be able to export to the United States boneless (not ground) raw beef products, such as primal cuts, chuck, blade, and beef trimmings, processed in certified Namibian establishments, because FSIS only assessed Namibia's meat inspection system with respect to these products. Namibia would need to submit additional information for FSIS to review before FSIS would allow Namibia to export other beef product or product from other types of livestock to the United States. All products that Namibia exports to the United States will be subject to reinspection at United States ports-of-entry by FSIS inspectors. Text is available in English at https://www.gpo.gov/fdsys/pkg/FR-2016-07-13/html/2016-16546.htm.

APHIS is proposing to amend the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States. These criteria, if met, would allow us to approve new cold treatment facilities without rulemaking and facilitate the importation of fruit requiring cold treatment while continuing to provide protection against the introduction of pests of concern into the United States. We are also proposing to amend the fruit cutting and inspection requirements in the cold treatment regulations in order to expand cutting and inspection to commodities that have been treated for a wider variety of pests of concern. This action would provide for a greater degree of phytosanitary protection. We are also proposing to add requirements concerning the establishment of compliance agreements for all entities that operate fumigation facilities. Finally, we are proposing to harmonize language concerning State compliance with facility establishment and parameters for the movement of consignments from the port of entry or points of origin in the United States to the treatment facility in the irradiation treatment regulations with proposed language in the cold treatment regulations. These actions would serve to codify and make enforceable existing procedures concerning compliance agreements for these facilities. Federal Register/Vol. 81, No. 126/Thursday, 30 June 2016/Pgs. 42569-42576

APHIS is proposing to amend the regulations governing the importation of certain animals, meat, and other animal products by allowing, under certain conditions, the importation of bone-in ovine meat from Uruguay. Based on the evidence in a risk assessment that we have prepared, we believe that bone-in ovine meat can safely be imported from Uruguay provided certain conditions are met. This proposal would provide for the importation of bone-in ovine meat from Uruguay into the United States, while continuing to protect the United States against the introduction of foot-and-mouth disease. Federal Register/Vol. 81, No. 127/Friday, 1 July 2016/Pgs. 43115-43120

The Food and Drug Administration has filed a petition, submitted by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc., requesting that we amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned.

This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus amyloliquefaciens strain PTA-4838 on all food commodities when applied or used as a fungicide, nematocide, or plant growth regulator. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus amyloliquefaciens strain PTA-4838.