(If the link doesn't work, go to Regulations.gov and search on "FDA-2002-N-0031" - then limit it only to items with a comment period Open and you'll see 1 Proposed Rule. That's the one you want.)
Sample Comment Letter for Your Use (You are free to use all or part of this letter):
April 9, 2009
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket Number: FDA-2002-N-0031 (formerly Docket No. 2002N-0273)
Dear Administrator,
Under no circumstances should the U.S. Food and Drug Administration (FDA) delay its April 27, 2009, scheduled implementation of the final rule titled "Substances Prohibited from Use in Animal Food or Feed," commonly referred to as the 2008 BSE final rule, while the U.S. Department of Agriculture (USDA) continues to subject U.S. consumers and the U.S. cattle herd to a heighted risk of bovine spongiform encephalopathy (BSE) from imports of live Canadian cattle, particularly imports of Canadian cattle over 30 months (OTM) of age.
U.S. consumers and the U.S. cattle herd are now subjected to a heightened risk of BSE because the U.S. continues to import millions of live cattle from Canada, where the disease prevalence is between three cases per million to eight cases per million cattle. The U.S. Centers for Disease Control and Prevention (CDC) states this level of BSE prevalence in the Canadian cattle herd is 18-fold to 48-fold higher than the prevalence estimated in the U.S. cattle herd. Just in 2008, nearly 1.6 million Canadian cattle were imported into the United States.
When USDA reopened the U.S. border in 2007 to Canada's highest-risk cattle population - OTM cattle - its risk modeling based on a Canadian BSE prevalence of fewer than 4 cases per million predicted that the U.S. would import over 100 head of BSE-infected cattle from Canada over the next 20 years. In addition, the risk modeling showed that human exposure to BSE would increase. However, as the CDC explained, the BSE prevalence in Canada could well be 8 cases per million, meaning that USDA likely has grossly underestimated the risk of introducing BSE-infected cattle into the U.S. as a result of allowing OTM Canadian cattle imports.
Canada already has detected 16 native cases of BSE in its OTM cattle herd, 10 of which were born after the 1997 feed ban. The most recent of these cases was detected just last November. Nine of Canada's BSE-infected cattle met USDA's age requirements to be exported to the United States, as they were born after March 1, 1999, the date after which USDA erroneously claims BSE-infectivity was no longer circulating in Canada.
The current U.S. feed ban implemented in 1997 is comparable to the initial Canadian feed ban also implemented in 1997. Canada's feed ban proved ineffective at preventing the spread of BSE in Canada. Despite the repeated urging of international scientists, Canada resisted any upgrades to its feed ban until after it detected multiple BSE cases in cattle born years after its 1997 feed ban. Canada's July 2007 upgraded feed ban now protects Canadian consumers against the spread of BSE from Canadian cattle by closing known transmission routes, including cross-contamination and inadvertent feeding of contaminated cattle parts. It is unthinkable that the FDA would not afford U.S. consumers the same level of protection against these same Canadian cattle that are imported into the United States.
The FDA cannot legitimately argue that its current feed ban implemented in 1997, which is nearly identical to Canada's original feed ban also implemented in 1997, is any more effective at mitigating Canada's heightened BSE risk within U.S. borders than it was in mitigating Canada's heightened BSE risk in Canada. Nor can FDA ignore the scientific evidence that overwhelmingly shows that the current U.S. feed ban is insufficient to mitigate the heightened BSE risk associated with OTM cattle imported from Canada. These higher-risk OTM Canadian cattle are entering the U.S. at the rate of several thousand per week, are being commingled in the U.S. cattle herd where some would be expected to die, and are entering both the U.S. food system as well as the U.S. animal feed system. The U.S. already is accepting Canada's higher BSE risk without the protections necessary to mitigate that higher risk.
The FDA cannot bury its head in the sand and pretend the upgraded feed ban contained in the 2008 BSE final rule is not urgently needed to mitigate the increased BSE risk associated with the importation of millions of Canadian cattle. In fact, the FDA already has failed to timely implement an upgraded feed ban, which should have been implemented before USDA began to expose U.S. consumers and the U.S. cattle herd to Canada's heightened BSE risk.
The FDA has an absolute responsibility to protect the health and safety of U.S. consumers and the U.S. cattle herd against this foreign animal disease that is always fatal, believed to be transferable to humans, and is not known to be circulating in the U.S. feed system after the 1997 U.S. feed ban. The FDA must break away from the manipulative actions by corporate-controlled, self-serving trade associations that have caused both FDA and USDA to endanger the health and safety of U.S. consumers and the U.S. cattle herd by exposing them to an unnecessary and avoidable risk of BSE.
Either USDA must immediately eliminate the source of this heightened BSE risk by prohibiting the importation of OTM Canadian cattle, or FDA must immediately implement the 2008 BSE final rule to mitigate this heightened risk. There are no responsible alternatives.
Sincerely,
