Animal and Plant Health Inspection Service October 2010 – Federal Register Recent Federal Regulation Documents

We are reopening the comment period for our proposed rule that would establish definitions for the terms ``common cultivar'' and ``common food crop.'' This action will allow interested persons additional time to prepare and submit comments.

We are amending the regulations that allow the importation of Fuji variety apples from Japan to allow all varieties of Malus domestica apples into the United States under the same conditions as those for Fuji variety apples. We have determined that the risk associated with allowing other varieties of M. domestica apples from Japan into the United States is the same as that posed by Fuji variety apples. This rule allows all varieties of M. domestica apples from Japan to be imported into the United States while continuing to protect against the introduction of quarantine pests.

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data.'' This draft guideline provides information concerning the development of a single electronic message to transmit adverse event reports concerning veterinary biologics between regulatory authorities in the European Union, Japan, and the United States and marketing authorization holders (veterinary biologics licensees and permittees) in those regions. Because the draft guideline applies to pharmacovigilance and adverse event reporting on veterinary vaccines 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 amending the regulations concerning the importation of citrus fruit to remove certain restrictions on the importation of Unshu oranges from the Republic of Korea that are no longer necessary. Specifically, we are removing requirements for the fruit to be grown in specified canker-free export areas and for joint inspection in the groves and packinghouses by the Government of the Republic of Korea and the Animal and Plant Health Inspection Service. We are also amending the regulations to clarify that surface sterilization of the fruit must be conducted in accordance with 7 CFR part 305 and to expand the area in the continental United States where Unshu oranges from the Republic of Korea may be distributed. Finally, we are requiring that each shipment be accompanied by a phytosanitary certificate containing an additional declaration stating that the fruit was given the required surface sterilization and inspected and found free of Elsinoe australis. These changes will make the regulations concerning the importation of Unshu oranges from the Republic of Korea consistent with our domestic regulations concerning the interstate movement of citrus fruit from areas quarantined because of citrus canker.

We are proposing to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh shepherd's purse with roots from the Republic of Korea into the United States under a combination of mitigations to reduce the risk of introducing plant pests. As a condition of entry, the shepherd's purse would have to be produced in accordance with a systems approach that would include requirements for importation of commercial consignments, pest-free place of production, removal of soil, and inspection for quarantine pests by the national plant protection organization of the Republic of Korea. The shepherd's purse would also have to be accompanied by a phytosanitary certificate with an additional declaration stating that it was grown, packed, and inspected and found to be free of pests in accordance with the proposed requirements. This action would allow the importation of fresh shepherd's purse with roots from the Republic of Korea while continuing to protect against the introduction of plant pests into the United States.

The Animal and Plant Health Inspection Service has received a supplemental request for ``partial deregulation'' or similar administrative action from the Monsanto Company and KWS SAAT AG for the planting, harvesting, and interstate movement of Roundup Ready[supreg] sugar beets under measures designed to ensure any risks posed by cultivation are mitigated. This notice is to inform the public of the availability of the documents submitted to the Agency from Monsanto Company and KWS SAAT AG requesting a ``partial deregulation.''

On May 27, 2010, we advised the public that the Animal and Plant Health Inspection Service prepared an environmental assessment and a finding of no significant impact relative to a request to allow the interstate movement of municipal solid waste from Hawaii to a landfill in the State of Washington. Because we have been made aware of additional information that was not previously provided and we have an interest in examining that information to determine the potential impacts, we are withdrawing the finding of no significant impact effective immediately in order to reevaluate the potential for environmental impacts that may be associated with this action.