Animal and Plant Health Inspection Service February 15, 2008 – Federal Register Recent Federal Regulation Documents
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Draft Guideline: Target Animal Safety for Veterinary Live and Inactivated Vaccines
The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Target Animal Safety for Veterinary Live and Inactivated Vaccines.'' This draft guideline provides guidance for designing and executing studies to evaluate the safety of the final formulation of veterinary live and inactivated vaccines in animals. Because the draft guideline may have an effect on the requirements for vaccines that are regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of the guideline and its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee.
Notice of Availability of a Risk Analysis for the Foot-and-Mouth Disease Status of the Republic of South Africa
We are advising the public that a risk analysis has been prepared by the Animal and Plant Health Inspection Service concerning the foot-and-mouth disease status of the Republic of South Africa and the related disease risks associated with importing animals and animal products into the United States from the Republic of South Africa. This risk analysis will be used as a basis for determining whether to relieve certain prohibitions and restrictions on the importation of ruminants and swine and the fresh meat and other animal products of ruminants and swine into the United States from the Republic of South Africa. We are making this risk analysis available to the public for review and comment.
Planet Biotechnology, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Field Release To Produce Antibodies in Genetically Engineered Nicotiana Hybrids
We are advising the public that we have prepared an environmental assessment for a proposed field release involving a Nicotiana hybrid line that has been genetically engineered to produce an antimicrobial antibody that binds to a bacterium (Streptococcus mutans) associated with tooth decay in humans. The purpose of this field release is to generate plant biomass from which the antibody will be extracted after harvest. The environmental assessment provides a basis for our conclusion that this field release will not present a risk of introducing or disseminating a plant pest and will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for this field release.
SemBioSys Genetics, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Proposed Field Release of Genetically Engineered Safflower
We are advising the public that an environmental assessment has been prepared for a proposed field release of a safflower line genetically engineered to express, within its seeds, human proinsulin fused to an Arabidopsis oleosin molecule. After our assessment of the application, review of pertinent scientific information, and consideration of comments provided by the public, we have concluded that this field release will not present a risk of introducing or disseminating a plant pest, nor will it have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for these field releases.
Oregon State University; Availability of an Environmental Assessment and Finding of No Significant Impact for a Controlled Release of Genetically Engineered Populus Species and Hybrids
We are advising the public that an environmental assessment has been prepared for a proposed controlled field release of genetically engineered (transgenic) clones of Populus species and hybrids. The purpose of this controlled field release is to examine the effects of the genetic constructs on the intended traits of reproductive sterility, reduced stature, reduced light response, and modified lignin content. After assessing the application, reviewing pertinent scientific information, and considering public comments, we have concluded that this field release will not present a plant pest risk, nor will it have a significant impact on the quality of the human environment. Based on the environmental analysis that there are no significant impacts associated with this controlled field release, the Animal and Plant Health Inspection Service has determined that a finding of no significant impact is appropriate and therefore an environmental impact statement need not be prepared for this field release.
Importation of Solid Wood Packing Material; Record of Decision
This notice advises the public of the Animal and Plant Health Inspection Service's record of decision for the supplement to the Importation of Solid Wood Packing Material Final Environmental Impact Statement.
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