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July 23, 2012
@USDA_ARS New Issue of Healthy Animals Newsletter.
http://tiny.cc/803ohwPosted by sball at 11:45 AM
Expanded Voluntary Recall of Land O’Lakes Purina Feed Products Due to Potential Elevated Vitamin D Level –
http://www.fda.gov/Safety/Recalls/ucm312982.htmPosted by sball at 9:10 AM
July 18, 2012
U.S. Food and Drug Administration Issues Guidance Document on Pyrogen and Endotoxins Testing
The U.S. Food and Drug Administration (FDA) has issued guidance on the use of alternatives to the rabbit pyrogen test (RPT) and the bacterial endotoxins test (BET) for detecting pyrogens in pharmaceuticals and other products. “Guidance for Industry – Pyrogen and Endotoxins Testing: Questions and Answers,” issued June 2012, includes guidance regarding the use of alternatives to the RPT or the BET. Firms producing products for which pyrogen testing is required may use alternative methods if they provide advantages in terms of accuracy, sensitivity, precision, selectivity, or adaptability to automation or computerized data reduction, and in other special circumstances. Alternative methods should be subjected to appropriate validation and shown to achieve equivalent or better results compared to the standard method. The document also provides guidance for transitioning from one test method to another.As examples of alternative assays that may be used, the guidance document cites the recombinant horseshoe crab Factor C assay and monocyte activation type pyrogen tests (MATs). ICCVAM recommended in 2008 that MATs could be considered for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT, in accordance with applicable U.S. Federal regulations. The ICCVAM recommendations were accepted by Federal agencies, including the FDA. Information on the NICEATM-ICCVAM evaluation of the in vitro pyrogen test methods can be found on the NICEATM-ICCVAM website at http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm.
ICCVAM has given a high priority for further discussion to a 2011 nomination to ICCVAM for activities to expand the applicability domain of a MAT that measures IL-1 release from cryopreserved human blood cells to include detection of non-endotoxin pyrogens.
The FDA guidance is available on the agency’s website at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310098.pdf.
Posted by sball at 2:28 PM
Hold the Date: NICEATM-ICCVAM International Workshop, November 28-29, 2012
The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an "International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward" on November 28-29, 2012. The workshop will be held at the William H. Natcher Conference Center at NIH headquarters in Bethesda, Maryland. NICEATM is organizing the workshop in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and partner organizations in the InternationalCooperation on Alternative Test Methods. The upcoming workshop will provide a forum to discuss and review protocols and available data from an ongoing study of in vitro alternatives to the HIST test. The workshop will review new innovative methods and approaches for acellular pertussis vaccine safety testing that may provide greater accuracy, precision, and efficiency and that are more humane and use fewer or no animals. Finally, the workshop will address the path to achieve validation, global acceptance, and implementation of new alternative methods for acellular pertussis vaccine testing.For More Information Registration information and a draft workshop agenda are available on the NICEATM-ICCVAM website at http://iccvam.niehs.nih.gov/meetings/HISTWksp-2012/HISTWksp.htm. Those planning to attend the workshop should preregister by November 16, 2012. NICEATM and ICCVAM also invite the submission of abstracts for scientific poster presentations on current research, development, and validation of alternatives to the HIST. Abstracts should be submitted by October 12, 2012. If you have questions about the workshop or would like more information, please contact NICEATM at niceatm@niehs.nih.gov.
Posted by sball at 11:43 AM
@USDA_ARS Look at the July issue of @USDA_ARS’ premier science magazine.
http://tiny.cc/dglehwPosted by sball at 10:59 AM
Updated Questions and Answers Regarding Chicken Jerky Treats from China
(includes link to Jerky Pet Food Lab Samples Analyzed spreadsheet) – http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm295445.htmPosted by sball at 10:27 AM
July 17, 2012
Evaluation of In Vitro Ocular Test Methods: Data and Nominations of Scientific Experts Requested
http://iccvam.niehs.nih.gov/methods/ocutox/STE-IRE.htmPosted by sball at 11:03 AM
Scientific Advisory Committee on Alternative Toxicological Methods to Meet Sept. 5-6
http://ntp.niehs.nih.gov/go/32822Posted by sball at 11:00 AM
July 16, 2012
USDA Extends Comment Period for Retail Pet Sales Proposed Rule
https://www.federalregister.gov/articles/2012/07/16/2012-17283/animal-welfare-retail-pet-stores-and-licensing-exemptionsPosted by sball at 11:46 AM