Animal and Plant Health Inspection Service 2005 – Federal Register Recent Federal Regulation Documents

We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports to require veterinary biologics licensees and permittees to record specific information concerning adverse events associated with the use of biological products that they produce or distribute and to compile and submit those records in a summary report to the Animal and Plant Health Inspection Service (APHIS) every 12 months for products licensed for 1 year or more; for newly licensed products, a summary report would have to be submitted at 6-month intervals during the first year of the product license and at 12-month intervals thereafter. The summary report would also have to identify the number of doses, or the average number of doses, of the product in distribution channels, if available. These records and reports would help ensure that APHIS will be able to provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document, that contained fewer specifics concerning the information that would have to be recorded in adverse event reports associated with the use of veterinary biologics that are submitted to the Agency.

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Monsanto Company seeking a determination of nonregulated status for corn designated as transformation event MON 88017, which has been genetically engineered for resistance to a corn rootworm complex and for tolerance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting public comments on whether this corn presents a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for a field trial of genetically engineered strains of an endophytic fungus of perennial ryegrass, Neotyphodium sp. isolate Lp1. The fungi have been genetically engineered to disrupt the ergovaline synthesis pathway. This environmental assessment is available for public review and comment.

We are adopting as a final rule, without change, an interim rule that amended the brucellosis regulations concerning the interstate movement of swine by adding Florida to the list of validated brucellosis-free States. The interim rule was based on our determination that Florida meets the criteria for classification as a validated brucellosis-free State. That action relieved certain restrictions on the interstate movement of breeding swine from Florida.

We are amending the imported fire ant regulations by designating as quarantined areas all of 1 county in Arkansas and all or portions of 18 counties in Tennessee. As a result of this action, the interstate movement of regulated articles from those areas will be restricted. This action is necessary to prevent the artificial spread of imported fire ant to noninfested areas of the United States.

We are notifying the public that the Animal and Plant Health Inspection Service has received a petition requesting that specific standards be promulgated for the humane handling, care, treatment, and transportation of domestic ferrets. We are soliciting comments from the public regarding the petition, and whether we should continue to regulate the handling, care, treatment, and transportation of ferrets covered by the Animal Welfare Act under the general standards in the regulations, or promulgate specific standards for ferrets. We are also requesting comments regarding what should be included in any such standards.

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment relative to the control of saltcedar (Tamarix spp.). The environmental assessment considers the effects of, and alternatives to, the release of a nonindigenous leaf beetle, Diorhabda elongata, into the environment to reduce the severity of saltcedar infestations. The environmental assessment provides a basis for our conclusion that the release into the environment of the biological control agent will not present a risk of introducing plant pests into the United States or disseminating plant pests within the United States and will not have a significant impact on the quality of the human environment. Based on its findings of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

We are advising the public that we are finalizing, with minor changes, a draft document that had been prepared by the Animal and Plant Health Inspection Service to identify the smallest administrative jurisdictions within 11 Member States of the European Union that we would consider ``regions'' in the event of future animal disease outbreaks. The draft document referred to these jurisdictions as ``administrative units'' and also reevaluated the administrative units already identified for Italy.

We are adopting as a final rule, without change, an interim rule that amended the bovine tuberculosis regulations regarding State and zone classifications by raising the designation of California from modified accredited advanced to accredited-free. The interim rule was based on our determination that California met the criteria for designation as an accredited-free State.

We are advising the public of our determination that cotton designated as transformation Event COT102, which has been genetically engineered for insect resistance, 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 Syngenta Seeds, Inc., in its petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice. This notice also announces the availability of our written determination and our finding of no significant impact.

We are proposing to amend the cut flowers regulations to establish specific requirements for the importation of cut flowers that are hosts of chrysanthemum white rust (CWR) from countries where the disease is known to occur. We are also proposing to amend the nursery stock regulations to update lists of countries where CWR is known to occur. We are proposing these changes in order to make our cut flowers and nursery stock regulations consistent. This action is necessary because of numerous recent findings of CWR on cut flowers from Europe that pose a risk of introducing CWR in the United States.

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Mycogen Seeds/Dow AgroScience LLC and Pioneer Hi-Bred International Inc seeking a determination of nonregulated status for corn designated as corn line DAS-59122-7, which has been genetically engineered for resistance to a corn rootworm complex and for tolerance to the herbicide glufosinate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting public comments on whether this corn presents a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.

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 for collecting user fees, ensuring remittances in a timely manner, and determining proper credit for payment of international air passenger, aircraft clearance, commercial truck, commercial railroad car, commercial vessel, phytosanitary certificate, import/export, and veterinary diagnostic user fees.

We are amending the Mexican fruit fly regulations by removing a provision that allows regulated articles to be moved interstate from a regulated area without a certificate or limited permit if they are moved into States other than commercial citrus-producing States. Additionally, we are amending the regulations to remove references to quarantined States and to refer to regulated areas as quarantined areas. We are also making other changes to the regulations, including clarifying that an entity requiring the services of an inspector is responsible for the costs of services performed outside of normal business hours. These actions are necessary to prevent the interstate spread of Mexican fruit fly and make the Mexican fruit fly regulations more consistent with our other domestic fruit fly regulations.

In accordance with the Paperwork Reduction Act, this notice announces the Office of Management and Budget's approval of a collection of information contained in the Animal and Plant Health Inspection Service's final rule regarding the possession, use, and transfer of select agents and toxins.

We are advising the public of our determination that the Monsanto Company and Forage Genetics International alfalfa lines designated as events J101 and J163, which have been genetically engineered for tolerance to the herbicide glyphosate, are no longer considered regulated articles under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto Company and Forage Genetics International in their petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition for nonregulated status and an environmental assessment. This notice also announces the availability of our written determination document and our finding of no significant impact.

We are adopting as a final rule, without change, two interim rules regarding Oriental fruit fly. The first interim rule designated a portion of Orange County, CA, as a quarantined area and provided for the use of spinosad bait spray as an alternative treatment for premises. The second interim rule removed the quarantine on that portion of Orange County, CA, and thus removed the restrictions on the interstate movement of regulated articles from that area. The first interim rule was necessary to prevent the spread of Oriental fruit fly to noninfested areas of the United States, and to provide an alternative to malathion bait spray to treat premises that produce regulated articles within the quarantined area. The second interim rule was necessary to reflect our determination that the Oriental fruit fly had been eradicated from Orange County, CA.

We are adopting as a final rule, without change, an interim rule that amended the citrus canker regulations by updating the list of areas in the State of Florida quarantined because of citrus canker. The interim rule expanded one established quarantined area, added several new quarantine areas, and removed a portion of one quarantined area. These actions were necessary to prevent the spread of citrus canker into noninfested areas of the United States and to relieve restrictions that were no longer warranted.

We are giving notice that the Secretary has renewed the Advisory Committee on Foreign Animal and Poultry Diseases for a 2-year period. The Secretary is soliciting nominations for membership for this Committee.

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 regulations for importation of clementines to the United States from Spain.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval by the Office of Management and Budget of an information collection associated with wildlife damage management programs.

We are proposing to amend the regulations to revise the approved doses for irradiation treatment of imported fruits and vegetables. This proposal would establish a new minimum generic dose of irradiation for most arthropod plant pests, establish a new minimum generic dose for the fruit fly family, reduce the minimum dose of irradiation for some specific fruit fly species, and add nine pests to the list of pests for which irradiation is an approved treatment. These actions would allow the use of irradiation to neutralize more pests and to neutralize some pests at lower doses. Furthermore, we are proposing to provide for the irradiation of fruits and vegetables moved interstate from Hawaii at the pest-specific irradiation doses that are now approved for imported fruits and vegetables. We are also proposing to provide for the use of irradiation to treat fruits and vegetables moved interstate from Puerto Rico and the U.S. Virgin Islands. These actions would allow irradiation to serve as an alternative to other approved treatments for additional fruits and vegetables moved interstate from Hawaii, Puerto Rico, and the U.S. Virgin Islands. Finally, we are proposing to add irradiation as a treatment for bananas from Hawaii and to add vapor-heat treatment as an optional treatment for sweetpotatoes from Hawaii. These actions would provide an alternative to the currently approved treatments for those commodities while continuing to provide protection against the spread of plant pests from Hawaii into the continental United States.

We are proposing to amend the pine shoot beetle regulations to allow pine bark products to be moved interstate from quarantined areas during the shoot feeding stage (July 1 through October 31) of the pine shoot beetle's life cycle without treatment. We are proposing this change because pine shoot beetles are not present in pine bark products during this stage. We are also proposing to establish a management method to allow pine bark products to be moved interstate from quarantined areas during the overwintering stage (November 1 through March 31) and spring flight stage (April 1 through June 30) of the pine shoot beetle's life cycle. This action would relieve restrictions on the interstate movement of pine bark products from quarantined areas during 4 months of the year and provide for the use of a management method as an alternative to fumigation with methyl bromide for pine bark products moved interstate from quarantined areas during the rest of the year.