December 15, 2003
USDA Issues Proposed Rule to Amend BSE Regulations
Dec. 2003 -- In an announcement made Oct. 31, 2003, the U.S. Department of Agriculture (USDA) issued a proposed rule to amend its bovine spongiform encephalopathy (BSE) regulations to create a new category of countries and regions.
The new category would recognize those countries/regions that present a ?minimal risk? of introducing BSE into the United States via the importation of low-risk live ruminants and ruminant products.
The proposed minimal risk region would include regions in which an animal has been diagnosed with BSE, but where among other things, specific preventative measures have been in place for an appropriate period of time to reduce the risk of BSE being introduced into the United States. The rule would list Canada as a minimal risk country for BSE, making it eligible to export certain live ruminants and ruminant products under specified conditions.
According to the proposed rule, lambs less than 12 months of age could be imported directly to slaughter, and feeder lambs could be imported to "designated feedlots" and then to slaughter at less than 12 months of age. Imported lambs would be tattooed with a mark designating them as originating in Canada.
USDA also released the findings of a second assessment conducted by the Harvard Center for Risk Analysis. The study found that even if infected animals or ruminant feed material entered the U.S. animal agriculture system from Canada, the risk of it spreading extensively within the U.S. herd is extremely low. Any possible spread would now have been reversed by controls put in place in the late 1990s, and the disease would eventually be eliminated from the United States.
?ASI has met with Canadian sheep producer representatives twice this fall to hear their concerns,? said American Sheep Industry Association (ASI) President Guy Flora. ?ASI?s comments to the proposed rule allowing resumption of live trade will be thoroughly examined and submitted to the Department by the deadline.
?We will be distributing comments to the sheep industry leadership in advance to assist with additional comment,? Flora added. ?Change, if any, will be months in the making given the procedure of public comment and review."
Comments will be considered if received on or before Jan. 5, 2004, and can be submitted by e-mail to: email@example.com
A copy of the Federal Register document is available at: http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=2003_register&docid=fr04no03-5
on the World Wide Web.
FDA Issues Guidance Document About Antimicrobial Resistance Prevention
The Food and Drug Administration (FDA) recently issued a new guidance document that outlines a comprehensive evidence-based approach to preventing antimicrobial resistance in humans that may result from the use of antimicrobial drugs in animals.
Antimicrobial drugs, such as antibiotics, are often used to treat bacterial infections in both humans and animals. When bacteria develop resistance to antimicrobials, both human and animal health is at risk because the medicines used to treat infections become ineffective.
The purpose of the new FDA draft document is to ensure the safety of animal drugs used in food-producing animals, and to evaluate the human health impact of their intended use. It addresses a recommended three-part approach for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern.
If the assessments show that the risks are significant, FDA could approve the drug with conditional usage or deny the application for marketing authorization.
Comments on the draft guidance will be accepted through the end of 2003 and should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or e-mailed to: firstname.lastname@example.org.
The full text of the document can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-1146-gdl0001.doc
U.S. Animal ID Plan Supported at USAHA Meeting
A national animal identification system was overwhelmingly endorsed by the U.S. Animal Health Association (USAHA) committee on livestock identification as ?a work in progress? at USAHA?s October meeting.
The committee encouraged further refinement and implementation of the draft U.S. Animal Identification Plan, which was proposed by a national animal identification development team.
It is hoped that individual premises identification, or Phase One of the system, will be in place by July 2004. The phase requires the establishment of standardized premise identification numbers for all production operations, including farms, ranches, markets, exhibitions and processing plants.
Phase Two calls for individual identification of cattle moving in commerce and is scheduled to be in place by the beginning of 2006.
The draft plan draws on existing voluntary and compulsory animal identification programs currently in place in the United States, and coordinates them into a truly national plan.
OIE Official Highlights Five Topics in Keynote Address
According to USAHA News, Dr. Barnard Vallat, director-general of the Office International des Epizooties (OIE), addressed five main topics in his keynote address at the joint session of the U.S. Animal Health Association and the American Association of Veterinary Laboratory Diagnosticians held in mid-October.
The five topics included: recognition of the veterinary profession; surveillance; worldwide policies against disease; zoning and compartmentalization; and pathogens and trade.
Vallat also mentioned that OIE will be developing animal welfare guiding principles. Transportation, humane slaughter and depopulation for disease control will first be addressed with housing and management to follow.
Surveillance Key to Combating Foreign Animal Disease Outbreaks
Effective surveillance is the key to detecting and controlling a foreign animal disease outbreak in the United States. That was the message delivered by several speakers at the U.S. Animal Health Association (USAHA) committee on foreign and emerging diseases meeting held in mid-October in San Diego.
Dr. Valerie Ragan of the U.S. Department of Agriculture?s (USDA) Animal and Plant Health Inspection Service (APHIS) provided an overview of a new national surveillance unit within APHIS. She indicated that historically, USDA has conducted surveillance targeted at single diseases. The new unit will develop a comprehensive, coordinated and integrated national system for disease surveillance.
Dr. Jerry Parker with the Department of Homeland Security (DHS) emphasized the absolute importance of protecting animal health as part of the national infrastructure. He said it is imperative to diagnose a foreign animal disease as soon as possible after introduction.
The vision remains unchanged: To create a world-class National Animal Health Emergency Management System, which includes a national response plan, state-local relationships and industry initiatives.
OIE Addresses Demands on Clarification of BSE Standards
In order to protect public and animal health while avoiding unjustified sanitary barriers, the World Trade Organization?s Standards Body for Animal Health (OIE) says it is continuing its mission of collecting the most recent scientific information with the aim of updating the international standards published in the OIE Code on an annual basis.
As has been done for the past 10 years, the OIE convened a group of world-wide known experts to take into account the most recent scientific knowledge to update the content and improve the understanding of the current OIE international standards on BSE. In addition, the OIE received a mandate from its 164 member countries asking them to consider simplifying the current country categorization according to BSE status existing in the International Code.
While the scientific content of the BSE Code has not been questioned, the OIE has been asked to provide additional clarification on the interpretation of the BSE standards. The current BSE standard serves as a strong foundation for facilitating international trade while protecting public and animal health.