Removal of the List of Ports of Embarkation and Export Inspection Facilities from the Regulations
We are proposing to amend the live animal export regulations by removing the list of designated ports of embarkation and their associated export inspection facilities. As a result of this rulemaking, those ports and facilities would henceforth be listed on the Internet rather than in the regulations, thus enabling us to amend the list, when necessary, in a timelier manner than we can now and allowing us greater flexibility in regulating animal exports.
Notice of Decision To Issue Permits for the Importation of Sweet Limes From Mexico Into the Continental United States
We are advising the public of our decision to begin issuing permits for the importation into the continental United States of sweet limes from Mexico. Based on the findings of a pest risk analysis, which we made available to the public for review and comment through a previous notice, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of sweet limes from Mexico.
Live Goats and Swine for Export; Removal of Certain Testing Requirements
We are proposing to amend the livestock exportation regulations to eliminate the requirement for pre-export tuberculosis and brucellosis testing of goats and breeding swine intended for export to countries that do not require such tests. This action would facilitate the exportation of goats and breeding swine by eliminating the need to conduct pre-export tuberculosis and brucellosis testing when the receiving country does not require such testing.
Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning expiration dating to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We also propose to require the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay; require stability monitoring of products after licensing; and specify a single standard for determining the expiration date for veterinary biologics in place of the current standard that specifies different procedures for products contingent upon whether they consist of viable or nonviable organisms. These amendments would update and clarify the regulations concerning expiration dating and establish a single uniform standard for determining the stability of veterinary biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.