Strengthen protections against BSE (mad cow disease)

March 29, 2010
The Honorable Tom Vilsack
Secretary of Agriculture

U.S. Department of Agriculture
1400 Independence Ave., S.W.
Washington, D.C. 20250

Docket No. APHIS 2008-0093
Regulatory Analysis and Development, PPD
APHIS, Station 3A-03.8
4700 River Road Unit 118
Riverdale, MD 20737-1238

Via Overnight Mail and Facsimile: 301-734-8934

Re: Urgent Request for Action to Strengthen U.S. BSE Protections; Supplemental Comments in Docket No. APHIS-2008-0093: Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Meat, Meat Byproducts, and Meat Food Products Derived From Bovines 30 Months of Age or Older

Dear Secretary Vilsack:

Many of us, the undersigned organizations, wrote you four months ago and asked you to promulgate bovine spongiform encephalopathy (BSE) rules that restore for U.S. livestock, livestock producers, and the people of the United States the highest possible level of protection against the introduction and spread of animal diseases. Those of us who were not joined in that earlier request do so now. For the reasons discussed below, we request that you restore the previous rules and regulations that prevented Canadian cattle over the age of 30 months from entering the United States.

On February 25, 2010, Canada confirmed its 18th BSE-positive case in a Canadian-born cow. This latest BSE-infected cow was reportedly born in 2004, indicating that the BSE agent continued to circulate in the Canadian feed system at least through all or part of 2004, which is years after the March 1, 1999, date established by the U.S. Department of Agriculture (USDA) as the date after which there would be an extremely low likelihood that Canadian cattle would be exposed to the BSE agent in Canadian animal feed.

With this latest case, Canada has detected 11 BSE-positive cases in cattle born after March 1, 1999. All of these BSE-positive cattle were detected between January 2006 and February 2010 under Canada’s BSE surveillance program, which is voluntary except in instances where an animal exhibits at least three of seven recognized BSE symptoms and is deemed a BSE suspect. During this longer than four-year surveillance period, Canada tested only 203,831 cattle. Thus, Canada has detected one BSE-positive case in a cow born after March 1, 1999, for each 18,530 cattle tested over about a four-year period.

It would be irresponsible for USDA to continue ignoring the empirical facts that show Canada’s ongoing BSE problem is far more serious than USDA predicted when it first relaxed U.S. disease safeguards in 2005, and then further relaxed those safeguards in 2007 to facilitate the importation of Canadian cattle born after March 1, 1999, and beef from cattle of any age. In support of its 2007 safeguard relaxation, the previous Administration considered the potential for BSE in Canadian cattle born after March 1, 1999, to be insignificant, and USDA stated that “such isolated incidents are not epidemiologically significant and do not contribute to further spread of BSE, especially when considered in light of the entire risk pathway and its attendant risk mitigations.” This pronouncement was made when only three Canadian cows born after March 1, 1999, had been confirmed BSE-positive. As shown below, your Administration should not condone this reckless and unscientific approach to protecting the people of the United States and U.S. livestock from the introduction and spread of BSE by allowing the over-thirty-month rule (OTM Rule) to remain in effect.

I. Canada’s Detection of 11 BSE-Positive Cattle Born after March 1, 1999, Cannot Be Considered Isolated, It Is Epidemiologically Significant, and it Does Contribute to the Spread of BSE

Canada’s ratio of the detection of BSE-positive cattle born after March 1, 1999, per 10,000 cattle tested is 0.54. This ratio of BSE-positive cases per 10,000 cattle tested is much higher than the 0.34 ratio of the detection of BSE-positive cases per 10,000 cattle tested in 2007 (latest available data) in the European Union (EU), which is comprised of 27 countries including the United Kingdom. The EU detected 174 BSE-positive cattle during that year. Canada’s 0.54 ratio of the detection of BSE-positive cattle born after March 1, 1999, per 10,000 cattle tested could be compared to the EU’s 2007 targeted testing results for the subpopulation of EU cattle considered “risk bovine animals,” which include only fallen stock, bovine animals with clinical signs at ante-mortem inspection, and emergency slaughter). The EU’s collective ratio of BSE-positive cases per 10,000 risk bovine animals tested in 2007 was 0.78, and 113 BSE-positive cases were detected in this risk subpopulation.

Indeed, when comparing Canada with individual EU countries considered to have high rates of BSE-positive cattle, Canada’s ratio is higher than the 2007 ratios for risk bovine animals in Germany, France, Italy, Netherlands, Austria, Czech Republic, and Poland.

Even if USDA’s inexplicable dismissal of the epidemiological significance of Canada’s rate of detection and ratio of detection of BSE-positive cases in Canadian cattle born after March 1, 1999, under Canada’s limited testing program, is momentarily excused, it remains an inescapable fact that these 11 BSE-positive cattle met the birth-date eligibility requirement to be exported to and subsequently slaughtered in the United States.

As a result, USDA must concede that the safety of beef derived from Canadian cattle (which beef is now commingled with the U.S. beef supply) is acutely contingent on the effectiveness of attendant U.S. risk mitigations to prevent human and livestock exposure to the BSE infectivity that is definitely known to exist in cattle eligible to enter the United States. And, USDA also must concede that the attendant risk mitigations that beef from Canadian cattle are subject to in the U.S. are less stringent than in either the EU or Japan, thus assuring that U.S. consumers are less protected from the introduction into their food supply of beef derived from a BSE-infected animal and tissues capable of spreading BSE than are consumers in the EU and Japan.

It appears that only USDA remains oblivious to the empirical evidence that demonstrates significant risk associated with Canadian cattle and beef from Canadian cattle that continue to enter and commingle with the United States’ cattle and beef supply. This explains why, after more than six years, the U.S. has been unsuccessful in the full restoration of confidence in the U.S. beef supply lost among its important export customers, notably Japan, South Korea and Hong Kong. And, with ongoing concerns expressed by our export customers, there is reason to believe that this may likewise explain, at least in part, why demand for U.S. beef has declined precipitously beginning in 2005, the year USDA first implemented its relaxation of restrictions against the importation into the United States of higher-risk Canadian cattle and beef. The fact that beef demand continued to decline since 2005 despite increases in annual exports suggests that domestic beef demand continues to be adversely impacted by USDA’s relaxed BSE standards. It also is not lost in the minds of consumers, both domestic and abroad, that USDA continues to prohibit U.S. meatpackers from voluntarily testing cattle at slaughter for BSE, even in the face of the heightened likelihood that some beef derived from imported Canadian cattle and some beef originating in Canada is derived from BSE-positive cattle.

II. USDA’s Assumption that Attendant Risk Mitigations Other than Border Restrictions, Which Now Are the United States’ Principle Defenses Against the Spread of and Infection from Canada’s BSE Outbreak, Are Adequate Is Demonstrably False

The chief assumptions relied on by USDA to support its contention that risks from Canadian cattle with BSE that enter the United States, and risks from beef derived from Canadian cattle with BSE that enter the U.S. food supply and animal feed supply, present only a negligible risk of BSE spread and BSE infection are that: 1) slaughter controls prevent the recycling of infectivity into human food and cattle feed, including the prohibition against the use of tissues from non-ambulatory cattle in the human food supply and the removal of specified risk materials from human food and animal feed; and, 2) feed manufacturing and use controls18 prevent the recycling of BSE into cattle feed.

Before providing empirical evidence to demonstrate that USDA’s assumptions regarding the adequacy of these crucial controls is unfounded, there is one overwhelming and irrefutable fact that somehow has escaped the scientific purview of the entire USDA agency: These and all other controls that USDA persistently claims are adequately implemented in Canada and elsewhere around the globe have not halted the ongoing spread of BSE in cattle or humans. This irrefutable detail is evidenced by Canada’s 11 cases of BSE detected in cattle born after March 1, 1999, with the latest case born in 2004; the 70 cases of BSE-positive cattle reported in 2009 to the World Organization for Animal Health (OIE) through Sept. 30, 2009, by 12 countries; and the 20 confirmed human deaths caused by the human form of BSE (Variant Creutzfeldt-Jakob Disease or vCJD) within about the past five years (January 2004-March 10, 2010), including the most recent death reported in 2010, which now brings the total number of confirmed deaths in vCJD victims in 11 countries to 219.

A. Slaughter Controls to Prevent the Recycling of Infectivity into Human Food Have Been Repeatedly Breached in the United States.

In 2008 the U.S. Government Accountability Office (GAO) found that contrary to USDA regulations that prohibit non-ambulatory cattle from entering the food system, non-ambulatory cows had been slaughtered at the Westland/Hallmark plant in California and the meat from those cows entered the U.S. food market. This violation purportedly was disclosed by a non-governmental source and resulted in the recall of more than 143 million pounds of beef, which according to the GAO was the largest meat recall in U.S. history. USDA reported in February 2008 that the violations at Westland/Hallmark had occurred occasionally over the past two years, and that some of the meat products produced by the firm were purchased for Federal food and nutrition programs, including the National School Lunch Program.

In addition to this major violation of U.S. BSE mitigation measures that occurred over an extended period of time, there are numerous other violations that continue to occur frequently, and all across the United States. It is apparent that the Westland/Hallmark case was not unique. As you know, on March 4, 2010, the U.S. House of Representatives Committee on Oversight and Government Reform’s Domestic Policy Subcommittee (Subcommittee) held a hearing titled: “Continuing Problems in USDA’s Enforcement of the Humane Methods of Slaughter Act.” At that hearing, the Subcommittee heard from Dr. Dean Wyatt, a USDA Food Safety and Inspection Service (FSIS) veterinarian and supervisor who described widespread mishandling of cattle, including slaughter of non-ambulatory calves, in violation of USDA regulations. Of even greater concern was Dr. Wyatt’s testimony that his efforts to enforce the Humane Methods of Slaughter Act were ignored, discouraged, and interfered with by USDA supervisors. Also on March 4, the Government Accountability Office issued a report, of which you no doubt are aware, that described inadequacies in FSIS’s approach to enforcement of the Humane Methods of Slaughter Act, making reference to instances where non-ambulatory animals were prodded to slaughter without any sanction being imposed on the slaughter plant.

There is evidence as well of continued, frequent violations of BSE mitigation measures from recalls that have been announced by FSIS. Below are examples of such frequent violations of U.S. BSE mitigation measures, particularly breaches of specified risk material (SRM) removal requirements, which further undercut USDA’s assumption that BSE risk pathways to humans have been effectively alleviated:

• Jan. 15, 2010: New York recall of a beef carcass that may not have had the spinal column removed.
• Oct. 17, 2009: Wisconsin recall of about 5,522 pounds of beef tongues that may not have had the tonsils completely removed.
• Oct. 16, 2009: California recall of approximately 11,500 pounds of assorted meat and poultry products (including beef) that were produced without the benefit of federal inspection.
• Oct. 15, 2009: Nebraska recall of approximately 33,000 pounds of beef tongues that may not have had the tonsils completely removed.
• May 29, 2009: Idaho recall of approximately 14,560 pounds of beef primal and subprimal products that were imported from Canada and not presented for re-inspection upon entry into the United States.
• Apr. 29, 2009: New York recall of approximately 16, 213 pounds of seasoning products, which contain cattle by-products, that were ineligible for import to the United States.
• Apr. 26, 2009: Michigan recall of an undetermined amount (estimated at 30,973 pounds) of frozen meat and poultry pasta products (including beef) that were prepared without the benefit of federal inspection.
• Mar. 28, 2009: South Carolina recall of approximately 2,925 pounds of beef and other meat that were mislabeled and possibly produced without the benefit of federal inspection.
• Aug. 7, 2008: Texas recall of approximately 941,271 pounds of cattle heads with tonsils not completely removed.
• Jun. 26, 2008: Missouri-based recall of approximately 120 pounds of fresh cattle heads with tonsils not completely removed.
• Jun. 26, 2008: Texas recall of approximately 2,850 pounds of fresh cattle heads which may contain SRMs.
• April 4, 2008: Kansas recall of approximately 406,000 pounds of frozen cattle heads with tonsils not completely removed.

The foregoing beef recalls included nearly 144.5 million pounds of beef that entered the U.S. food system during about the past two years, and involved firms operating in at least 10 separate states, all in violation of U.S. BSE mitigation requirements. These incidents that were caught undoubtedly represent only a fraction of the cattle that were processed without complying fully with required BSE mitigation measures. Thus, there likely are hundreds of thousands of U.S. consumers who have purchased beef that likely was not subject to U.S. BSE mitigation measures. This ongoing, potential human exposure to beef produced from BSE-positive cattle, for which mitigation measures were not adequately applied, is unnecessary and can and should immediately be avoided by prohibiting the introduction of cattle and beef from Canada—where the BSE agent is known to have recycled in that country’s feed system through at least all or part of 2004, and where it likely continued to recycle at least until Canada implemented its upgraded feed ban in mid-2007.

B. Feed Manufacturing Controls to Prevent the Recycling of Infectivity into Cattle Feed Have Been Repeatedly Breached in the United States.
A Feb. 11, 2009 warning letter issued by the U.S. Food and Drug Administration (FDA) disclosed that an Idaho-based animal feed manufacturer was found in June 2009 to be manufacturing adulterated animal feed due to the manufacturer’s failure to provide measures to avoid commingling or cross-contamination of feed containing ruminant protein, and for subsequently misbranding feed that was not properly labeled. Commingling or cross-contamination has been implicated as the leading cause of BSE-infection in Canadian cattle born
after Canada implemented its 1997 feed ban, including in the 11 cases of BSE-positive cattle in Canada that were born after March 1, 1999.

A March 5, 2010, article published in Food Safety News stated that the manufacturing firm cited by FDA for manufacturing the adulterated animal feed distributed animal feed to nine states: Idaho, Nevada, Utah, Wyoming, Colorado, Montana, Washington, California, and Oregon.31 Neither the FDA warning letter nor the related news article specified how long the manufacturer had been distributing the adulterated feed. Nevertheless, it is clear that this breach of BSE-related feed manufacturing controls has resulted in a potential, widespread exposure of the BSE agent to many U.S. cattle in many states.

In addition to the widespread, potential exposure to the BSE agent caused by the breach of the feed manufacturer in Idaho, the FDA reports there have been other significant incidences of non-compliance with U.S. feed manufacturing controls. For example, the FDA issued a warning letter in Oct. 2006 to an animal feed protein supplement manufacturing facility in Alabama for producing adulterated feed by failing to implement measures to prevent commingling or cross-contamination of prohibited proteins, as well as for subsequently misbranding animal feeds during the longer than 15-month period from February 2005 through June 9, 2006. Although the warning letter did not state the market area served by the manufacturer of the adulterated feed, the duration of the violation indicates the potential that there was substantial exposure to adulterated feed by U.S. livestock.

Also in 2006, a Louisiana rendering plant was issued a warning letter by FDA for violating U.S. BSE-related feed manufacturing controls, again by failing to prevent commingling or cross-contamination with prohibited protein and for misbranding feed. And, in June 2005, FDA inspectors found that a Minnesota rendering plant was in violation of FDA’s requirements to prohibit certain proteins in ruminant feed. The investigation revealed the rendering plant failed to use proper clean-out procedures to prevent cross-contamination and failed to properly label feed to prevent its consumption by ruminant animals.

The foregoing instances of confirmed breaches to U.S. BSE-related feed manufacturing controls demonstrate that for an extended period of time, and over a widespread geographic area, U.S. livestock likely were exposed to feed products potentially containing BSE infectivity. This
ongoing, potential livestock exposure to infectivity from BSE-positive cattle, for which mitigation measures were not adequately applied, is unnecessary and can and should immediately be avoided by prohibiting the introduction of cattle and beef from Canada (where the BSE agent is known to have recycled in that country’s feed system through at least all or part of 2004, and where it likely continued to recycle at least until Canada implemented its upgraded feed ban in mid-2007).

III. Conclusion
The ongoing detection of BSE-positive Canadian cattle born at ever increasing intervals beyond the March 1, 1999, date that USDA determined was the date the Canadian feed ban was effectively enforced, and the fact that the ever-increasing number of infected cattle are detected under an extremely limited and largely voluntary BSE surveillance program, presents an acute health and safety risk to the people of the United States and to U.S. livestock. The agency’s previous contention that the diagnosis of BSE-positive cases in cattle born after March 1, 1999, represents only isolated incidences that are not epidemiologically significant and that do not contribute to the risk of further spread of BSE has now been demonstrated to be incorrect. These multiple cases, instead, provide empirical evidence that Canada’s feed ban has been ineffective in halting the continual recycling of BSE infectivity within Canada’s animal feed supply. In addition, these cases effectively elevate the importance of other BSE mitigation measures – measures other than Canada’s feed ban – to protect the people of the United States and U.S. livestock from exposure to Canada’s high level of BSE infectivity. Unfortunately, the assumptions relied on by USDA regarding the effectiveness of these other measures to protect against the introduction and spread of BSE in the United States are, likewise, demonstrably false.

Mr. Secretary, above all other considerations, the health and safety of the people of the United States and United States’ livestock must come first – first before trade and first before international relations. Your agency’s current BSE policies and regulations compromise directly this health and safety priority and we, the undersigned, urge you to take immediate action to, at the very least, restore for the United States the protections against the introduction and spread of BSE that were in place before USDA began to systematically dismantle its BSE-related border restrictions. We respectfully implore you to, as a first step, immediately overturn the OTM Rule.

Sincerely,

National Organizations:

American Grassfed Association
BueLingo Beef Cattle Society
CJD Foundation
Coalition for a Prosperous America (CPA)
Consumer Federation of America (CFA)
Farm and Ranch Freedom Alliance
Food & Water Watch
Freedom21, Inc.
International Texas Longhorn Association
National Association of Farm Animal Welfare
Organization for Competitive Markets (OCM)
R-CALF USA
Socially Responsible Agricultural Project (ID)
Sovereignty International, Inc.
Texas Longhorn Marketing Alliance
The Dairy Education Alliance
Western Organization of Resource Councils (WORC)

State, Regional and County Organizations:

California Farmers Union
CARE (Pacific Northwest)
Cattle Producers of Washington
Colorado Independent CattleGrowers Association
Concerned Citizens of the Yakama Reservation (WA)
Idaho Rural Council
Independent Beef Association of North Dakota
Independent Cattlemen of Iowa
Independent Cattlemen of Nebraska
Independent Cattlemen of Wyoming
Michigan Farmers Union
Mississippi Livestock Markets Association
Missouri Farmers Union
Missouri Rural Crisis Center
Nebraska Farmers Union
Nebraska Women Involved in Farm Economics
Nevada Live Stock Association
New England Farmers Union
Ohio Farmers Union
Oregon Farmers Union
Oregon Rural Action
South Dakota Stockgrowers Association
Spokane County Cattlemen’s Association (WA)
Stevens County Cattlemen’s Association (WA)

cc: Members of Congress
U.S. Centers for Disease Control and Prevention
State Animal Health Officials