Animal and Plant Health Inspection Service August 2016 – Federal Register Recent Federal Regulation Documents

We are amending the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we are also amending the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These changes are necessary in order to update and clarify labeling requirements and to ensure that information provided in labeling is accurate with regard to the expected performance of the product.

We are proposing to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh persimmons from New Zealand into the United States. As a condition of entry, the persimmons would have to be produced in accordance with a systems approach that would include requirements for orchard certification, orchard pest control, post harvest safeguards, fruit culling, traceback, sampling, and treatment with either hot water or modified atmosphere treatment. The persimmons would also have to be accompanied by a phytosanitary certificate with an additional declaration stating that they were produced under, and meet all the components of, the systems approach and were inspected and found to be free of quarantine pests in accordance with the proposed requirements. This action would allow the importation of fresh persimmons from New Zealand while continuing to protect against the introduction of plant pests into the United States.

We are reopening the comment period for our proposed rule that would amend the fruits and vegetables regulations to list lemon (Citrus limon (L.) Burm. f.) from Chile as eligible for importation into the continental United States subject to a systems approach. This action will allow interested persons additional time to prepare and submit comments.

This is a notice to inform the public of an upcoming meeting of the Secretary's Advisory Committee on Animal Health. The meeting is being organized by the Animal and Plant Health Inspection Service to discuss matters of animal health.

We are amending the National Poultry Improvement Plan (NPIP), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza. Specifically, we are clarifying who may participate in the NPIP, amending participation requirements, amending definitions for poultry and breeding stock, amending the approval process for new diagnostic tests, and amending slaughter plant inspection and laboratory inspection and testing requirements. These changes will align the regulations with international standards and make them more transparent to Animal and Plant Health Inspection Service stakeholders and the general public. The changes in this final rule were voted on and approved by the voting delegates at the Plan's 2014 National Plan Conference.

We are advising the public that the Animal and Plant Health Inspection Service plans to prepare an updated environmental impact statement to analyze the effects of a program to eradicate exotic fruit fly species from wherever they might occur in the United States, including Hawaii, Guam, American Samoa, Puerto Rico, and the U.S. Virgin Islands. This notice identifies potential issues and alternatives that will be studied in the environmental impact statement, and requests public comments to further delineate the scope of the alternatives and environmental impacts and issues.

We are advising the public of our decision to authorize the importation of fresh figs (Ficus carica) from Peru into the continental United States. Based on the findings of a pest risk analysis, which we made available for the public to review and comment through a previous notice, we have concluded that the application of designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests via the importation of fresh figs from Peru.

We are 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.

We are proposing to amend the Animal Welfare Act (AWA) regulations in response to a 2014 Farm Bill amendment to the Act that provides the Secretary of Agriculture with the authority to determine that animal dealers and exhibitors are not required to obtain a license under the Act and regulations if the size of the business conducting AWA-related activities is determined to be de minimis by the Secretary. The Animal and Plant Health Inspection Service has reviewed past compliance with the Animal Welfare Act of currently-regulated facilities and has determined that de minimis businesses, as defined in the rule are capable of providing adequate care and treatment of the animals involved in regulated business activities. We also propose amending the regulations in response to a 2013 amendment to the Act that excludes from the definition of ``exhibitor'' some owners of household pets that are exhibited occasionally, generate less than a substantial portion of income, and reside exclusively with the owner. Dealers and exhibitors operating at or below the thresholds determined for their particular AWA-related business activity would be exempted from Federal licensing requirements established under the Act and regulations. Our proposed actions would amend the regulations to be consistent with the Act while continuing to ensure the humane care and treatment of animals covered under the AWA.

We are announcing that the Animal and Plant Health Inspection Service intends to prepare an environmental impact statement (EIS) to evaluate the environmental impacts that may result from the approval of a new petition for nonregulated status of glyphosate-resistant creeping bentgrass (Agrostis stolonifera L.) (event ASR368) from The Scotts Company and Monsanto Company following withdrawal of their 2003 petition. Issues to be addressed in the EIS include the potential environmental impacts to managed natural and non-agricultural lands, agricultural production systems, the physical environment, biological resources, human health, socioeconomics, federally listed threatened or endangered species, and cultural or historic resources. This notice of intent (NOI) replaces a previous NOI published in September 2004 and initiates a fresh public scoping process and stakeholder engagement for the purpose of preparing an EIS. We are requesting public comments to further frame the scope of the issues to be included in the EIS, including alternatives and environmental impacts.

We are giving notice that the Secretary of Agriculture intends to renew the charter for the Secretary's Advisory Committee on Animal Health for a 2-year period. The Secretary has determined that the Committee is necessary and in the public interest.