Animal and Plant Health Inspection Service September 17, 2010 – Federal Register Recent Federal Regulation Documents

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.

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.