The U.S. Department of Agriculture (USDA) has 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, a progressive neurological disease among cattle that is always fatal, into the United States via the importation of certain low-risk live ruminants and ruminant products.
USDA’s Animal and Plant Health Inspection Service (APHIS) is seeking public comment on the proposal to allow the importation of certain live ruminants and ruminant products and by-products from minimal risk regions under specified conditions. This proposed rule would place Canada on a list of countries considered at 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 USDA 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.
Under the proposed rule, 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 www.aphis.usda.gov.
The proposed rule is consistent with the approach taken by the Office International des Epizooties (OIE), now the World Organization for Animal Health – 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 1990s, 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.
USDA commissioned the risk reassessment 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 Administra-tion’s (FDA’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 Web site at www.usda.gov.
USDA Preventive Action
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. Also beginning in 1997, FDA prohibited the use of most mammalian protein in the manufacture of animal feed in-tended 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 was 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 what is referred to as 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.
Commenting on the Proposal
Comments on this proposed rule must be received on or before January 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. E-mail comments to regulations@aphis.usda.gov. Comments must be contained in the body of the message, not as an attached file. Include your name and address in the message and use “Docket No. 03-080-1” on the subject line.
Newsline - December 2003 Render