Release No. 0372.03

WASHINGTON, Oct. 31, 2003–The United States Department of Agriculture today issued a proposed rule to amend its bovine spongiform encephalopathy (BSE) regulations to establish a new category of regions that recognizes those that present a minimal risk of introducing BSE into the United States via the importation of certain low-risk live ruminants and ruminant products.

USDA’s Animal and Plant Health Inspection Service is seeking public comment on the proposal to allow the importation of certain live ruminants and ruminant products and byproducts from minimal risk regions under specified conditions. This proposed rule would place Canada on a list of countries considered a minimal risk for BSE, thus making Canada eligible to export certain live ruminant and ruminant products.

“The United States has a long history of having safeguards in place to prevent the introduction of BSE,” said Agriculture Secretary Ann M. Veneman. “The continued protection of the U.S. food supply is our top priority. This proposal reflects a thorough review of the scientific evidence, which shows the risk to public health to be extremely low.”

The proposed minimal risk region would include regions in which an animal has been diagnosed with BSE but in which specific preventive measures have been in place for an appropriate period of time that reduce the risk of BSE being introduced to the United States. Based on a comprehensive risk analysis and review, USDA believes that the surveillance, prevention and control measures implemented by Canada are sufficient to be included in the minimal risk category.

The proposed rule has a 60-day comment period. Once this period closes, USDA will consider the comments as it makes any final decisions on the importation of certain live ruminants and ruminant products from Canada and other minimal risk regions for BSE.

Under this proposal, ruminant and ruminant products eligible for entry into the United States from a BSE minimal risk region would include: 1) bovine animals less than 30 months of age for immediate slaughter; 2) bovine animals for feeding to be moved to a designated feedlot and then to slaughter at less than 30 months of age; 3) sheep and goats less than 12 months of age for immediate slaughter; 4) sheep and goats for feeding to be moved to a designated feedlot and then to slaughter at less than 12 months of age; 5) cervids for immediate slaughter; 6) fresh (chilled or frozen) meat from bovines less than 30 months of age; 7) fresh (chilled or frozen) whole or half carcasses of bovines less than 30 months of age; 8) fresh (chilled or frozen) bovine liver; 9) fresh (chilled or frozen) bovine tongues; 10) fresh (chilled or frozen) meat of sheep or goats less than 12 months of age; 11) fresh (chilled or frozen) carcasses of sheep or goats less than 12 months of age; 12) hunter-harvested wild ruminant products; 13) fresh (chilled or frozen) meat of cervids either farm-raised or harvested on a game farm or similar facility; 14) fresh (chilled or frozen) meat from wild- harvested caribou, musk ox, or other cervids; and 15) certain types of gelatin, tallow and offal. A full listing of the risk mitigation measures required to be eligible for entry into the United States can be found at http://www.aphis.usda.gov/.

The proposed rule is consistent with the approach taken by the World Organization for Animal Health (OIE) – the standard setting organization for animal health for 164 member nations. In recent correspondence, the Director General of the OIE acknowledged that there has been an “increase in unjustified restrictions in international trade, particularly as it relates to cattle and cattle products.” The letter was in response to a request from Secretary Veneman, Agricultural Minister Lyle Vanclief, Canada, and Agriculture Secretary Javier Usabiaga, Mexico, to the OIE to provide more practical guidance regarding the resumption of trade with countries that have reported cases of BSE. The United States continues to work with the OIE to ensure that countries establish import policy decisions based on standards that are commensurate with the BSE risks identified for each situation.

HARVARD RISK REASSESSMENT

USDA also released the findings of a second assessment conducted by the Harvard Center for Risk Analysis (HCRA) that confirms the findings of the initial study released in 2001. 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 was low, that any possible spread would now have been reversed by controls put in place in the late 1990’s, and that eventually, the disease would be eliminated from the United States.

“This study shows that the measures taken in the United States over the years greatly reduce the chance of BSE spreading and help ensure that the disease will not become a major animal or public health problem in America,” said Dr. George Gray, executive director of HCRA.

The risk reassessment was commissioned by USDA shortly after the discovery of a single case of BSE in Canada on May 20, 2003. The study evaluates the potential for BSE to spread if it were introduced from Canada prior to May 20, when USDA banned all ruminant and ruminant products from Canada because of the discovery of the single case of BSE. The reassessment specifically examined scenarios for the likely introduction of BSE from Canada into the United States.

The scenarios used for this assessment included hypothetical introductions at various times of both infected animals and contaminated animal feed. These scenarios were entered into the HCRA computer model that simulates conditions in the U.S. cattle herd given the actions that have already been taken to minimize the risk of spreading the disease. In the worst case scenario, where infection was introduced as early as 1990, the results demonstrated that the disease could have spread with a peak infection rate occurring in 1997 and peak numbers of clinical cases occurring in 2000. When infection was introduced later in 1996 or 1998, there was minimal or no spread of the disease.

As with the initial study, which hypothetically introduced as many as 500 infected animals into the U.S. herd, the Food and Drug Administration’s 1997 ban on feeding most mammalian protein back to other ruminants essentially stops the possible spread of the disease.

Even allowing for incomplete compliance with that feed ban, the HCRA analysis finds that, had infected animals or feed come in from Canada or elsewhere, by now the spread of BSE in the U.S. herd would have been reversed and that human exposure to contaminated animal tissue would have been very low.

A complete copy of the second Harvard Report can be obtained from USDA’s official website at http://www.usda.gov/.

USDA PREVENTIVE ACTION

BSE is a progressive neurological disease among cattle that is always fatal. It belongs to a family of diseases known as transmissible spongiform encephalopathies. Also included in that family of illnesses is variant Creutzfeldt-Jakob Disease (vCJD), which is believed to be caused by eating neural tissue, such as brain and spinal cord, from BSE affected cattle.

BSE has never been detected in U.S. cattle. The USDA and other agencies have had preventive measures in place since recognition of BSE as a serious disease. Since 1989, USDA has banned the import of live ruminants, such as cattle, sheep and goats, and most ruminant products from the United Kingdom and other countries having BSE. The ban was extended to Europe in 1997. And, as more evidence was accumulated about how the disease spread, the Food and Drug Administration prohibited the use in 1997 of most mammalian protein in the manufacture of animal feed intended for cows and other ruminants.

Since 1990, USDA has had an aggressive BSE surveillance program in place to ensure detection and swift response in the event that an introduction of BSE were to occur. Last year, USDA tripled testing levels and this year testing reached an all-time high of 20,526 head, or 47 times the level recommended by the OIE. Because of the May 20, 2003 occurrence of a single case of BSE in Canada, APHIS is reviewing its current level of surveillance to continue to ensure a high confidence level.

USDA’s Food Safety and Inspection Service is evaluating a proposal to further address specified risk material such as brain and spinal cord to continue to reduce any potential risk. These tissues are considered to be the most infectious in animals with BSE. Therefore, this measure could further reduce the already very low risk of BSE in the United States, thus providing additional protection for consumers.

TO COMMENT ON THE PROPOSAL

The notice of proposed rulemaking to permit entry of low-risk live animals from certain minimal risk regions is scheduled for publication in the Nov. 4 Federal Register. APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/.

Consideration will be given to comments received on or before Jan. 5, 2004. Comments may be submitted by postal mail, commercial delivery or by e-mail. Send an original and three copies of postal or commercial delivery comments to Docket No. 03-080-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, Md. 20737-1238. If you use e-mail, address your comments to [email protected] Comments must be contained in the body of the message; do not send attached files. Please include your name and address in the message and use “Docket No. 03-080-1″ on the subject line.

Comments received may be reviewed at USDA, Room 1141, South Building, 14th Street and Independence Avenue, S.W., Washington, D.C., between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to review comments are requested to call ahead on (202) 690-2817 to facilitate entry into the comment reading room.

The 40-page proposed rule can be accessed at: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-27611.htm.