Animal and Plant Health Inspection Service – Federal Register Recent Federal Regulation Documents
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Notice of Request for Extension of Approval of an Information Collection; Importation of Unshu Oranges From the Republic of Korea Into the Continental United States
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the regulations for the importation of Unshu oranges from the Republic of Korea into the continental United States.
Importation of Lemons From Chile Into the Continental United States
We are proposing to 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. Under this systems approach, the fruit would have to be grown in a place of production that is registered with the Government of Chile and certified as having a low prevalence of Brevipalpus chilensis. The fruit would have to undergo pre-harvest sampling at the registered production site. Following post-harvest processing, the fruit would have to be inspected in Chile at an approved inspection site. Each consignment of fruit would have to be accompanied by a phytosanitary certificate with an additional declaration stating that the fruit had been found free of Brevipalpus chilensis based on field and packinghouse inspections. This proposed rule would allow for the safe importation of lemons from Chile using mitigation measures other than fumigation with methyl bromide.
Importation of Fresh Cherimoya Fruit From Chile Into the United States
We are proposing to amend the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States, provided that fruit is produced in accordance with a systems approach, as an alternative to the currently required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment. The proposed systems approach would include requirements for production site registration, low pest prevalence area certification, post-harvest processing, and fruit cutting and inspection at the packinghouse. 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 Chile with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach would continue to be allowed to be imported into the United States subject to treatment. This action would allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.
Notice of Request for Revision to and Extension of Approval of an Information Collection; APHIS Pest Reporting and Asian Longhorn Beetle Program
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection that allows the public to report sightings of plant pests and diseases.
Modernizing the Regulatory System for Biotechnology Products; Notice of Third Public Meeting
Under the auspices of the National Science and Technology Council, USDA, along with the White House Office of Science and Technology Policy, the Environmental Protection Agency and the Food and Drug Administration (FDA) are holding the third public meeting related to the memorandum entitled, ``Modernizing the Regulatory System for Biotechnology Products,'' issued by the Executive Office of the President in July 2015. The purpose of the third public meeting is to illustrate current Federal roles and responsibilities regarding biotechnology products. The docket, FDA-2015-N-3403, established by FDA prior to the first public meeting, will continue to be used for this interagency effort.
National Poultry Improvement Plan and Auxiliary Provisions
We are proposing to amend the National Poultry Improvement Plan (NPIP, the Plan), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza to clarify participation in the NPIP and amend participation requirements, amend definitions for poultry and breeding stock, amend the approval process for new diagnostic tests, and amend laboratory inspection and testing requirements. These changes would align the regulations with international standards and make them more transparent to Animal and Plant Health Inspection Service stakeholders and the general public. The proposed changes were voted on and approved by the voting delegates at the Plan's 2014 National Plan Conference.
Asian Longhorned Beetle Eradication Program; Record of Decision
We are advising the public that the Animal and Plant Health Inspection Service has prepared a record of decision for the final environmental impact statement for the Asian Longhorned Beetle Eradication Program.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Live Poultry, Poultry Meat, and Other Poultry Products From Specified Regions
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval of a revision to and extension of an information collection associated with regulations for the importation of live poultry, poultry meat, and other poultry products from specified regions.
Availability of an Environmental Assessment for the Biological Control of Cape Ivy
We are advising the public that the Animal and Plant Health Inspection Service has prepared a draft environmental assessment relative to the control of Cape ivy, Delairea odorata. The environmental assessment considers the effects of, and alternatives to, the field release of a gall-forming fly, Parafreutreta regalis, into the continental United States for use as a biological control agent to reduce the severity of Cape Ivy infestations. We are making the environmental assessment available to the public for review and comment.
Environmental Impact Statement; Animal Carcass Management: Record of Decision
We are advising the public that the Animal and Plant Health Inspection Service has prepared a record of decision for the programmatic environmental impact statement titled ``Carcass Management During a Mass Animal Health Emergency.''
Black Stem Rust; Additions of Rust-Resistant Species and Varieties
On January 22, 2016, the Animal and Plant Health Inspection Service published a direct final rule. The direct final rule notified the public of our intention to amend the black stem rust quarantine and regulations by adding nine varieties to the list of rust-resistant Berberis species and varieties. We received two comments, which are addressed in this document.
Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Pomegranates From Peru Into the Continental United States
We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with importation of fresh pomegranate fruit from Peru 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 pomegranates from Peru. We are making the pest risk analysis available to the public for review and comment.
Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Figs From Peru Into the Continental United States
We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with importation of fresh figs (Ficus carica) from Peru 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 figs from Peru. We are making the pest risk analysis available to the public for review and comment.
Animal Welfare; Marine Mammals
We are extending the comment period for our proposed rule that would amend the Animal Welfare Act regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. This action will allow interested persons additional time to prepare and submit comments.
Brucellosis and Bovine Tuberculosis; Update of General Provisions
We are extending the comment period for our proposed rule that would consolidate the domestic regulations governing bovine tuberculosis and those governing brucellosis and revise the bovine tuberculosis- and brucellosis-related import requirements for cattle and bison to make these requirements clearer and assure that they more effectively mitigate the risk of introduction of these diseases into the United States. This action will allow interested persons additional time to prepare and submit comments.
Availability of an Environmental Assessment for Field Testing a Canine Osteosarcoma Vaccine, Live Listeria Vector
We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Canine Osteosarcoma Vaccine, Live Listeria Vector. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the risk analysis and other relevant data, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment, and that an environmental impact statement need not be prepared. We intend to authorize shipment of this vaccine for field testing following the close of the comment period for this notice unless new substantial issues bearing on the effects of this action are brought to our attention. We also intend to issue a U.S. Veterinary Biological Product license for this vaccine, provided the field test data support the conclusions of the environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing.
International Sanitary and Phytosanitary Standard-Setting Activities
In accordance with legislation implementing the results of the Uruguay Round of negotiations under the General Agreement on Tariffs and Trade, we are informing the public of the international standard- setting activities of the World Organization for Animal Health, the Secretariat of the International Plant Protection Convention, and the North American Plant Protection Organization, and we are soliciting public comment on the standards to be considered.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Fresh Bananas From the Philippines Into the Continental United States
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh bananas from the Philippines into the continental United States.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Sand Pears From China
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of sand pears from China into the United States.
Environmental Impact Statement; Introduction of the Products of Biotechnology
We are extending the comment period for our notice of intent to prepare a programmatic environmental impact statement in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This action will allow interested persons additional time to prepare and submit comments.
General Conference Committee of the National Poultry Improvement Plan; Meeting
We are giving notice of a meeting of the General Conference Committee of the National Poultry Improvement Plan.
General Conference Committee of the National Poultry Improvement Plan; Solicitation for Membership
We are giving notice that the Secretary of Agriculture is soliciting nominations for the election of regional membership, a member-at-large, and alternates to the General Conference Committee of the National Poultry Improvement Plan.
Notice of Request for Extension of Approval of an Information Collection; Horse Protection Regulations
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the Horse Protection Program.
Recognizing European Union (EU) and EU Member State Regionalization Decisions for African Swine Fever (ASF) by Updating the APHIS List of Regions Affected With ASF
We are advising the public that we added European Union (EU) and EU Member State-defined regions of the EU to the Animal and Plant Health Inspection Service (APHIS) list of regions affected with African swine fever (ASF). Going forward we will recognize as affected with ASF any region of the EU that the EU or any EU Member State has placed under restriction because of detection of ASF. These regions currently include portions of Estonia, Latvia, Lithuania, and Poland, and all of Sardinia. APHIS will list the EU- and EU Member State-defined regions as a single entity. We also removed Sardinia as an individually listed region from the APHIS list of ASF affected regions. We took these actions because of the detection of ASF in Estonia, Latvia, Lithuania, and Poland.
Golden Nematode; Removal of Regulated Areas in Orleans, Nassau, and Suffolk Counties, New York
We are adopting as a final rule, without change, an interim rule that amended the golden nematode regulations by removing areas in Orleans, Nassau, and Suffolk Counties in the State of New York from the list of generally infested areas. The interim rule was necessary to relieve restrictions on the movement of regulated articles from areas no longer under quarantine for golden nematode. As a result of the interim rule, movement of such articles from areas no longer under quarantine can proceed while preventing the spread of golden nematode from infested areas to noninfested areas of the United States.
Monsanto Co.; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate
We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary determination regarding a request from Monsanto Co. seeking a determination of nonregulated status for maize designated as event MON 87419, which has been genetically engineered for resistance to the herbicides dicamba and glufosinate. We are also making available for public review and comment our preliminary plant pest risk assessment, draft environmental assessment, and preliminary finding of no significant impact for the preliminary determination of nonregulated status.
Syngenta Seeds Inc.; Availability of a Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Insect and Glufosinate-Ammonium Resistance
We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of Pioneer corn event DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event MZIR098 in response to a request from Syngenta Seeds Inc. MZIR098 corn has been genetically engineered for resistance to insects and to the herbicide glufosinate-ammonium using the same mechanism of action as Pioneer 4114. We are making available for public comment our preliminary regulatory determination, preliminary finding of no significant impact, and plant pest risk similarity assessment for the proposed determination of nonregulated status.
Importation of Phalaenopsis Spp. Plants for Planting in Approved Growing Media From China to the Continental United States
We are amending the regulations governing the importation of plants for planting to authorize the importation of Phalaenopsis spp. plants for planting from China in approved growing media into the continental United States, subject to a systems approach. The systems approach consists of measures that are currently specified in the regulations as generally applicable to all plants for planting authorized for importation into the United States in approved growing media. This rule allows for the importation of Phalaenopsis spp. plants for planting from China in approved growing media, while providing protection against the introduction of quarantine plant pests.
Notice of Request for an Extension of Approval of an Information Collection; Specimen Submission
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with livestock disease surveillance programs.
Conditions for Payment of Highly Pathogenic Avian Influenza Indemnity Claims
We are amending the regulations pertaining to certain diseases of livestock and poultry to specify conditions for payment of indemnity claims for highly pathogenic avian influenza (HPAI). Specifically, we are providing a formula that will allow us to split such payments between poultry and egg owners and parties with which the owners enter into contracts to raise or care for the eggs or poultry based on the proportion of the production cycle completed. This action is necessary to ensure that all contractors are compensated appropriately. We are also providing for the payment of indemnity for eggs required to be destroyed due to HPAI, thus clarifying an existing policy. Finally, we are requiring owners and contractors, unless specifically exempted, to provide a statement that at the time of detection of HPAI in their facilities, they had in place and were following a biosecurity plan aimed at keeping HPAI from spreading to commercial premises.
Highly Pathogenic Avian Influenza; Availability of Final Environmental Assessment and Finding of No Significant Impact
We are advising the public that the Animal and Plant Health Inspection Service has prepared a final environmental assessment and finding of no significant impact relative to a national approach for the control of highly pathogenic avian influenza outbreaks within the United States. Based on the environmental assessment and our review of all public comments received, we have concluded that such an approach will not have a significant impact on the quality of the human environment.
Environmental Impact Statement; Introduction of the Products of Biotechnology
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) plans to prepare a programmatic environmental impact statement in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This notice identifies reasonable alternatives and potential issues to be evaluated in the environmental impact statement and requests public comments to further define the scope of the alternatives and environmental impacts and issues for APHIS to consider.
Importation of Orchids in Growing Media From Taiwan
We are amending the regulations governing the importation of plants and plant products to add orchid plants of the genus Oncidium from Taiwan to the list of plants that may be imported into the United States in an approved growing medium, subject to specified growing, inspection, and certification requirements. We are taking this action in response to a request from the Taiwanese Government and after determining that the plants could be imported, under certain conditions, without resulting in the introduction into, or the dissemination within, the United States of a quarantine plant pest.
Animal Welfare; Marine Mammals
We are proposing to amend the Animal Welfare Act regulations concerning the humane handling, care, treatment, and transportation of marine mammals in captivity. These proposed changes would affect sections in the regulations relating to variances and implementation dates, indoor facilities, outdoor facilities, space requirements, and water quality. We are also proposing to revise the regulations that relate to swim-with-the-dolphin programs. We believe these actions are necessary to ensure that the minimum standards for the humane handling, care, treatment, and transportation of marine mammals in captivity are based on current industry and scientific knowledge and experience.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Wooden Handicrafts From China
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of wooden handicrafts from China.
Lacey Act Implementation Plan; Definitions for Exempt and Regulated Articles
We are adopting as a final rule, without change, an interim final rule that established definitions for the terms common cultivar and common food crop and several related terms. The 2008 amendments to the Lacey Act expanded its protections to a broader range of plant species; extended its reach to encompass products, including timber, that derive from illegally harvested plants; and required that importers submit a declaration at the time of importation for certain plants and plant products. Common cultivars and common food crops are among the categorical exclusions to the provisions of the Act. The Act does not define the terms common cultivar and common food crop but instead gives authority to the U.S. Department of Agriculture and the U.S. Department of the Interior to define these terms by regulation. The interim final rule specifically requested comment on definitions of two related terms: Commercial scale and tree. This document responds to comments we received on those definitions.
Black Stem Rust; Additions of Rust-Resistant Species and Varieties
We are amending the black stem rust quarantine and regulations by adding nine varieties to the list of rust-resistant Berberis species and varieties. This action will allow for the interstate movement of these newly developed varieties without unnecessary restrictions.
Importation of Fresh Apple and Pear Fruit Into the Continental United States From Certain Countries in the European Union
We are proposing to amend the regulations to allow the importation of fresh apple and pear fruit from certain countries in the European Union into the continental United States, provided that the fruit is produced in accordance with a systems approach, as an alternative to importation under the current preclearance program. The proposed systems approach for fresh apple and pear fruit consists of production site and packinghouse registration, inspection of registered production sites twice a season, production site pest control and sanitation, post-harvest safeguards, fruit culling, traceback, sampling, cold treatment against Mediterranean fruit fly in countries where the pest is known to occur, a phytosanitary certificate, port of entry inspection, and importation as commercial consignments only. Fresh apple and pear fruit that does not meet the requirements in the systems approach would continue to be allowed to be imported into the United States subject to the conditions of the preclearance program. This action would provide an alternative for the importation of fresh apple and pear fruit from certain countries in the European Union while continuing to provide protection against the introduction of plant pests into the continental United States.
Exportation of Live Animals, Hatching Eggs, and Animal Germplasm From the United States
We are revising the regulations pertaining to the exportation of livestock from the United States. Among other things, we are removing most of the requirements for export health certifications, tests, and treatments from the regulations, and instead directing exporters to follow the requirements of the importing country regarding such processes and procedures. We are retaining only those export health certification, testing, and treatment requirements that we consider necessary to have assurances regarding the health and welfare of livestock exported from the United States. We also are allowing pre- export inspection of livestock to occur at facilities other than an export inspection facility associated with the port of embarkation, under certain circumstances, and replacing specific standards for export inspection facilities and ocean vessels with performance standards. These changes will provide exporters and the Animal and Plant Health Inspection Service (APHIS) with more flexibility in arranging for the export of livestock from the United States while continuing to ensure the health and welfare of the livestock. Additionally, if APHIS knows that an importing country requires an export health certificate endorsed by the competent veterinary authority of the United States for any animal other than livestock, including pets, or for any hatching eggs or animal germplasm, we are requiring that the animal, hatching eggs, or animal germplasm have such a health certificate to be eligible for export from the United States. This change will help ensure that all animals, hatching eggs, and animal germplasm exported from the United States meet the health requirements of the countries to which they are destined. Finally, we are making editorial amendments to the regulations to make them easier to understand and comply with.
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations
In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement the findings of the fourth biennial review of the list. In addition, we are proposing several amendments to the regulations, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes would increase the usability of the select agent regulations as well as provide for enhanced program oversight.
The Scotts Co. and Monsanto Co.; Availability of Petition for Determination of Nonregulated Status of Creeping Bentgrass Genetically Engineered for Resistance to Glyphosate
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from the Scotts Company and Monsanto Company seeking a determination of nonregulated status of creeping bentgrass designated as event ASR368, which has been genetically engineered for resistance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Scotts Company and Monsanto Company petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that the Animal and Plant Health Inspection Service may determine should be considered in our evaluation of the petition.
Brucellosis and Bovine Tuberculosis; Update of General Provisions
We are proposing to consolidate the regulations governing bovine tuberculosis, and those governing brucellosis. As part of this consolidation, we are proposing to transition the tuberculosis and brucellosis programs away from a State classification system based in disease prevalence. Instead, States and Tribes would implement animal health plans that identify sources of the diseases within the State or Tribal lands and specify mitigations to address the risk posed by those sources. The consolidated regulations would also set forth standards for surveillance, epidemiological investigations, and affected herd management that must be incorporated into each animal health plan, with certain limited exceptions; would provide revised conditions for the interstate movement of cattle, bison, and captive cervids; and would provide revised conditions for APHIS approval of tests, testing laboratories, and testers for bovine tuberculosis or brucellosis. Finally, we are proposing to revise the bovine tuberculosis- and brucellosis-related import requirements for cattle and bison to make these requirements clearer and assure that they more effectively mitigate the risk of introduction of these diseases into the United States.
J.R. Simplot Company; Availability of Preliminary Finding of No Significant Impact, Similarity Assessment, and Preliminary Decision for an Extension of a Determination of Nonregulated Status to V11 Snowden Potatoes With Low Acrylamide Potential and Reduced Black Spot Bruise
We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of Innate\TM\ potato to Snowden potato variety event SPS-00V11-6 (hereinafter V11 potato) in response to a request from the J.R. Simplot Company. V11 potato has been genetically engineered to exhibit low acrylamide potential in cooked potatoes and reduced black spot bruise. We are making available for public comment our preliminary finding of no significant impact, our similarity assessment, and our preliminary extended determination of nonregulated status.
Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered for Increased Ear Biomass
We are advising the public of our determination that maize designated as event MON 87403, which has been genetically engineered for increased ear biomass, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto Company in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notices announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.
Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy
We are advising the public of our preliminary concurrence with the World Organization for Animal Health's (OIE) bovine spongiform encephalopathy (BSE) risk designations for 16 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.
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