Animal and Plant Health Inspection Service February 2008 – Federal Register Recent Federal Regulation Documents

We are amending the fruits and vegetables regulations by eliminating a treatment requirement for Ya pears imported from Shandong Province, China; clarifying the conditions that apply to the importation of sand pears from the Republic of Korea and Japan; and clarifying the distinction between plant parts that would be considered plant litter or debris and those that would not. These changes eliminate a treatment requirement that we have determined is no longer necessary and clarify some existing provisions in order to make the regulations easier to understand and implement.

We are amending brucellosis regulations by providing an exception in the definition of herd for animals held within a federally approved brucellosis research facility, in order to facilitate research on brucellosis-exposed or infected animals in those facilities. Prior to this rule, such animals constituted a herd, and the presence of brucellosis-positive herds within a State can adversely affect that State's brucellosis classification. By providing an exception for brucellosis-exposed or infected animals held within federally approved research facilities, this rule will enable initiation of necessary brucellosis research in Class Free States.

We are amending the Mediterranean fruit fly regulations by adding a portion of Los Angeles County, CA, to the list of quarantined areas and by restricting the interstate movement of regulated articles from that area. This action is necessary to prevent the artificial spread of Mediterranean fruit fly.

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.

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.

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.

We are proposing to amend the domestic quarantine regulations to establish regulations to restrict the interstate movement of South American cactus moth host material, including nursery stock and plant parts for consumption, from infested areas of the United States. This action would help prevent the artificial spread of South American cactus moth into noninfested areas of the 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 regulations for pork and poultry products from Mexico transiting the United States.

We are adopting as a final rule, without change, an interim rule that amended the regulations for the importation of unmanufactured wood articles to bring the methyl bromide treatment schedule into alignment with current international phytosanitary standards. The interim rule was necessary because international phytosanitary standards had changed, and our regulations needed to be updated to reflect the current standards.

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 and extension of approval of an information collection for self-certification medical statements.

We are amending the brucellosis regulations concerning the interstate movement of cattle by changing the classification of Texas from Class A to Class Free. We have determined that Texas meets the standards for Class Free status. This action relieves certain restrictions on the interstate movement of cattle from Texas.