Animal and Plant Health Inspection Service January 2011 – Federal Register Recent Federal Regulation Documents

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment and finding of no significant impact relative to the control of Asian citrus psyllid (Diaphorina citri Kuwayama). The environmental assessment considers the effects of, and alternatives to, the release of an insect, Tamarixia radiata, into the continental United States for use as a biological control agent to reduce the severity of Asian citrus psyllid infestations. Based on our finding of no significant impact, we have determined that an environmental impact statement need not be prepared.

We are amending the regulations concerning the importation of animals and animal products to prohibit or restrict the importation of bird and poultry products from regions where any subtype of highly pathogenic avian influenza is considered to exist. We are also adding restrictions concerning importation of live poultry and birds that have been vaccinated for certain types of avian influenza, or that have moved through regions where any subtype of highly pathogenic avian influenza is considered to exist. These restrictions supplement or replace existing restrictions on the importation of live birds and poultry, and bird and poultry products and byproducts from regions where exotic Newcastle disease or highly pathogenic avian influenza subtype H5N1 are considered to exist. They are necessary to prevent the introduction of highly pathogenic avian influenza into the United States.

We are advising the public of our decision to revise a heat treatment schedule for the emerald ash borer in the Plant Protection and Quarantine Treatment Manual and to retain the current treatment schedule with a different treatment number. Based on the findings of a treatment evaluation document, which we made available to the public for review and comment through a previous notice, we believe that the revised treatment schedule will be sufficient to treat emerald ash borer.

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment (EA) relative to the control of air potato (Dioscorea bulbifera). The EA considers the effects of, and alternatives to, the release of an insect, Lilioceris cheni, into the continental United States for use as a biological control agent to reduce the severity of air potato infestations. We are making the EA available to the public for review and comment.

We are proposing to amend 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 labeling for autogenous biologics to specify the microorganism(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 also propose to amend 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 proposed amendments are necessary in order to update and clarify labeling requirements and ensure that information provided in labeling is accurate with regard to the expected performance of the product.

We are adopting as a final rule, without change, an interim rule that amended the Asian longhorned beetle (ALB) regulations by adding a portion of Worcester County, MA, to the list of quarantined areas and updating the description of the quarantined area in the Borough of Staten Island in the City of New York, NY. The interim rule, which restricted the interstate movement of regulated articles from these areas, was necessary to prevent the artificial spread of ALB to noninfested areas of the United States.

We are adopting as a final rule, without change, an interim rule that amended the regulations to add areas in Maryland, Michigan, Minnesota, Missouri, Pennsylvania, Virginia, West Virginia, and Wisconsin to the list of areas quarantined because of emerald ash borer (EAB). The interim rule was necessary to prevent the artificial spread of EAB into noninfested areas of the United States. As a result of the interim rule, the interstate movement of regulated articles from those areas is restricted.

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Pioneer Hi-Bred International, Inc., seeking a determination of nonregulated status for corn designated as DP-32138-1, which has been genetically engineered to produce male sterile/female inbred plants for the generation of hybrid corn seed that is non-transgenic. 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 comments on whether this genetically engineered corn is likely to pose a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.