WASHINGTON (Apr 30, 1996 3:48 p.m. EDT) -- A consumer group and medical advocacy organization urged government regulators to strengthen protections against an outbreak of "mad cow disease" in the U.S.
Public Voice for Food & Health Policy urged the FDA and USDA to appoint an independent panel -- with consumer representation -- to oversee the effort to guard against bovine spongiform encephalopathy, or BSE.
The group also recommended a review of U.S. procedures and cattle to ensure that there's no BSE in the country and that processors are using the best methods of neutralizing the virus suspected of causing the disease.
"Given the lack of understanding of the disease-causing agent, the difficulties of surveillance and the severity of the disease, the federal government should err on the side of caution and take effective, preventive measures to make sure that BSE never becomes an American problem," said Public Voice President Mark Epstein.
Separately, the Physicians Committee for Responsible Medicine said it's prepared to sue the FDA and USDA to stop the feeding of animal remains to livestock and poultry.
"There is every reason to be concerned about an outbreak" of mad cow disease in the U.S., said Dr. Neal D. Barnard, president of 4,000 member organization. He said practices that led to the mad cow outbreak in the U.K. are common in the U.S.
That includes the feeding of ground-up animal organs, called offal, as a protein supplement to cattle, hogs and poultry. About 56 percent of all cattle feed contains offal, as does 66 percent of U.S. dairy feed, according to the USDA.
Barnard told reporters at a press conference that the livestock and poultry industry should stop feeding animal remains, Congress ought to ban the use of offal as a livestock protein supplement, and that the FDA and USDA shouldn't certify meats as fit for human consumption of animals that are fed offal.
The Agriculture Department has checked 499 cattle imported into the U.S. during the 1980s and "has never identified a single case" of BSE, said the department's Food Safety and Inspection Service.
The beef and dairy industry has urged the FDA to speed action on a rule to ban the feeding of offal to all ruminants -- cattle, sheep and goats.
A spokeswoman for the cattle industry, Alisa Harrison, said the physicians' group is going too far. "What they represent is an animal rights organization. They don't want people to eat beef."
In letters to FDA Commissioner David Kessler and Agriculture Secretary Dan Glickman, Public Voice also asked for a ban on feeding offal to livestock and poultry used for in human food and a requirement that cattle brains and spinal cords be removed during slaughter. It also sought assurance that countries that export cattle into the U.S. have reliable BSE surveillance methods, and recommended additional funds for the agencies to expand their BSE protections without sacrificing other efforts.
FDA officials weren't available for comment.
In Europe today, European Union farm ministers urged Britain to speed its efforts to eradicate the disease before they consider lifting a ban on Britain's beef exports.
BSE, a brain disease recently found among British cattle, has been linked to a rare, but fatal, brain disease in humans. Britain has proposed a selective slaughter of some 42,000 cattle considered most at risk from the disease. The EU ministers said that's not enough.
Public Voice for Food and Health Policy today urged the Food and Drug Administration and the Agriculture Department to create several additional layers of protection to assure safety and consumer confidence in the domestic food system in light of the "mad cow disease" outbreak in Britain.
Among other things, the 14-year-old consumer group recommended an immediate government ban on the type of livestock feed suspected of spreading the mysterious disease—known officially as bovine spongiform encephalopathy, or BSE—in Britain.
Public Voice also:
No cases of BSE have been diagnosed in U.S. cattle. The feed suspected of spreading BSE in British cows contains rendered tissue from sheep and cattle used as a protein supplement.
Public Voice made its recommendations in letters to Agriculture Secretary Dan Glickman and David Kessler, commissioner of the Food and Drug Administration. Public Voice President Mark Epstein complimented both agencies for the actions they have taken but urged them to "create several layers of protection" against BSE.
"Given the lack of understanding of the disease-causing agent, the difficulties of surveillance and the severity of the disease, the federal government should err on the side of caution and take effective preventive measures to make sure that BSE never becomes an American problem," Epstein said.
Public Voice also recommended:
The answer, Epstein said, is for FDA to issue a binding interim ban pending completion of the permanent ban. The British government, he noted, has already issued a ban on ruminant protein in ruminant feed and the World Health Organization has urged all nations to do the same.
Epstein said an independent BSE advisory panel is necessary because food safety responsibilities are divided among several different federal agencies. It's important that a single body be responsible for overseeing the entire effort and that this body be independent. Expanded surveillance efforts and a review of the domestic rendering process are also very important, Epstein said.
USDA hopes to expand current sampling of brain tissue from cattle with central nervous system disorders, targeting plants that slaughter large numbers of older, cull cows. Public Voice urged that this expansion occur quickly and that the sampling be significantly increased if a test is developed to detect BSE in animals before they show symptoms of the disease. Currently, BSE is only definitively diagnosed by examining brain tissue in dead animals.
The rendering process review, Public Voice said, should mandate procedures that prevent any infected animal tissue that might enter a rendering plant from contaminating non-infected tissue. Because of the long incubation period for BSE and related diseases, it is possible that tissue from infected animals could be processed without plant operators being aware of it. This could contaminate non-infected tissue, Public Voice noted.
The Honorable David A. Kessler
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Commissioner Kessler:
Public Voice for Food and Health Policy has been intensively researching bovine spongiform encephalopathy in recent weeks. I am writing to share with you a list of recommendations we feel are in the best interest of the federal government, the domestic food industry, and American consumers. A similar letter is being delivered to Agriculture Secretary Dan Glickman.
Public Voice believes that the federal government should err on the side of caution and take effective preventive measures to make sure that BSE never becomes an American problem.
We know from the steps that FDA has already taken that you also believe that a vigorous preventive effort is called for, and we feel that FDA deserves praise for its efforts to date. However, the BSE situation is an evolving story, and we think it is necessary to periodically reevaluate our prevention program.
Given the lack of understanding of the disease-causing agent, the difficulties of surveillance and the severity of the disease, we ask USDA and FDA to create several layers of protection for US consumers.
Specifically, we recommend that:
1. FDA should expedite its ban on ruminant protein in ruminant feed. If possible, it should issue an interim ban pending completion of the rulemaking process. If research reveals that BSE is transmissible by oral exposure to swine or poultry, the ban should be extended to ruminant protein in swine and poultry feed.
2. FDA should expeditiously undertake a careful review of rendering processes currently in use in the US. FDA should ensure that the rendering process is changed to incorporate methods that are most effective for inactivation of the scrapie and BSE agents, based on research in the US and Europe. In addition, FDA should mandate procedures in rendering facilities to prevent cross-contamination. Because of the long incubation periods for scrapie and BSE, asymptomatic but infected animals may be sent to slaughter plants and their offal rendered.
3. USDA and FDA should appoint an independent panel with a primarily public health orientation consisting of experts from outside the government, and including consumer representation, to evaluate all facets of our BSE-prevention strategy, similar to the Spongiform Encephalopathy Advisory Committee in Britain. Because of the way food safety responsibility is currently divided, different facets of our national strategy are being overseen by different federal agencies. We believe it is important that a single body be responsible for overseeing the entire effort and that that body be independent of both government and the affected industries. Currently, APHIS is taking the lead, because BSE has not yet been proven to be a human health hazard, and APHIS has made a laudable effort to coordinate its strategy with its sister agencies. However, until we know without qualification that there is no relationship between BSE and Creutzfeldt-Jakob disease, we must assume that BSE is a potential human health problem. We therefore recommend the creation of an independent panel with both human and animal health expertise.
4. USDA's Food Safety and Inspection Service (FSIS) should ban specified sheep offal (i.e., brain, spinal cord, thymus, spleen, tonsils, lymph nodes and intestines) from human food. FSIS should also ban cow brain and spinal cord from human food. Current regulations only ban the spinal cord from human food if it has been removed during slaughter. FSIS should require removal of the brain and spinal cord from cattle during slaughter.
5. FSIS and USDA's Animal and Plant Health Inspection Service (APHIS) should expand their surveillance of US cattle with central nervous system disorders as quickly as possible to be sure that BSE does not exist in this country. If and when a diagnostic test is developed that can detect pre-clinical BSE in live cattle, APHIS should test a statistically valid sample of high-risk live animals in a given population or, if feasible, in the entire country. APHIS is now in the process of training FSIS veterinarians, private practice vets, and cattle producers to recognize the symptoms of BSE. APHIS and FSIS are also sampling brain tissue from cattle with central nervous system disorders presented for slaughter at certain plants (selected because of the large number of older cull cows they slaughter); their goal is to gradually expand this so that a sample would be taken from any cattle with a CNS disorder presented for slaughter at any plant in the country.
6. FSIS and APHIS should ensure that countries that export beef and cattle to the US, such as Mexico and Canada, have reliable surveillance programs in place and communicate with these countries to ensure that their domestic herds remain free of BSE. According to the World Health Organization, "in the absence of surveillance data, the BSE status of a country must be considered as unknown."
7. Congress should appropriate the funds needed for USDA and FDA to take the measures outlined above. Funding for FSIS' BSE-prevention responsibilities must not be taken out of FSIS' budget for postmortem inspection and implementation of the Pathogen Reduction/HACCP regulation.
The above list of recommendations may not be comprehensive; there may be other recommendations we will wish to advance later as we learn more about this issue. We feel confident, however, making these recommendations now.
I welcome your input and hope that we can work together on this issue. I look forward to your response.
Sincerely,
Mark S. Epstein
President
TSEs include the following diseases: bovine spongiform encephalopathy in cattle; scrapie in sheep and goats; transmissible mink encephalopathy; feline spongiform encephalopathy in cats; chronic wasting disease in mule deer and elk; and Creutzfeldt-Jakob disease (CJD), kuru, Gerstmann-Straussler syndrome, and fatal familial insomnia in humans. Some other cases of TSEs have also been reported in Britain in exotic species, such as kudus, eland, nyala and gemsbok.
In the United States, there have been reported cases of scrapie, transmissible mink encephalopathy, wasting disease in mule deer and elk, and CJD. There have been no diagnosed cases of BSE in the United States.
Scrapie has been around for over 200 years, and there is no epidemiologic evidence that people can contract it by eating infected lamb or mutton. Britain has a lot of scrapie; the United States has little scrapie; and Australia and New Zealand have no scrapie. Yet all three countries have about the same rate of CJD, or one case per million people.
Kuru is an extremely rare TSE found in New Guineau and believed to be transmitted by ritual cannibalism involving consumption of or contact with brain tissue. Kuru is significant, because it suggests that primates can contract a TSE by ingesting infected tissue.
In 1986, the first cases of BSE were diagnosed in British cattle. Since then, some 162,000 British cattle have been struck by the disease. At its peak in 1992-93, there were about 1,000 new cases per week, but it dropped to about 300 new cases per week in January 1996 and continues to decline.
The source of the British outbreak is believed to be either scrapie-infected sheep or cattle infected with a previously unidentified TSE. Cattle and other livestock are sometimes fed protein supplements that include rendered tissue from sheep, cattle and other livestock. In the late 1970s or early 1980s, Britain changed its rendering procedures to remove a solvent extraction process that included a steam-heat treatment. It is believed that this change in the rendering process allowed the infectious agent, present in either sheep tissue or cattle tissue, to survive the rendering process and infect British cattle. In July 1988, because of BSE, Britain banned the use of cattle and sheep protein in cattle and sheep feed. In 1989, Britain instituted a specified bovine offal (SBO) ban which excluded all brain, spinal cord and other organs with potential BSE infectivity from human consumption.
Outside Britain, BSE has only appeared in countries to which Britain exported cattle in the 1980s. In six of those countries, including Canada, which has had only one diagnosed case of BSE, BSE did not spread from imported British cattle to domestic cattle. In Ireland, France, Switzerland and Portugal, BSE has shown up in domestic cattle.
The United States imported 499 cattle from Britain as breeding stock between 1981 and 1989. The U.S. Agriculture Department's Animal and Plant Health Inspection Service (APHIS) has been monitoring 464 of these cattle, of which 96 are still alive. The states in which these 96 cattle are located have quarantined them except for Pennsylvania (5 cattle) and Montana (one cow). Since no government, state or federal, controls the movement of these six un-quarantined British cattle, it would be possible for them to be slaughtered and their meat to enter the human food supply. APHIS has so far been unable to trace 35 imported British cattle of which only four or five are believed to be still alive.
Recently, USDA has announced plans to increase its surveillance effort. Agriculture Secretary Dan Glickman was quoted saying "we will bring up the surveillance." So far, however, this has mainly consisted of increased training and education about BSE for FSIS veterinarians, private practice vets, and cattle producers. APHIS is considering examining more brain tissue samples, but the exact scope of additional sampling has not been resolved and will depend in part on lab capacity.
Additional brain tissue samples would be taken from cattle with CNS disorders and, possibly, also from "downer" or "non-ambulatory" cattle (i..e., cattle that are unable to walk). USDA's immediate goal is to reach the point where a sample would be taken from any cattle showing signs of CNS disorder during antemortem inspection at any slaughter plant in the country. Currently, this is only true at approximately nine plants, but APHIS hopes to expand its coverage to roughly twenty plants that slaughter most of the cull cows, beef and dairy, in the country. It is important to target older cull cows, because due to BSE's long incubation period, younger cattle are unlikely to show symptoms of BSE even if infected. In Britain, most BSE cases have involved dairy cows between three and five years old.
APHIS has prepared a risk assessment for BSE in the United States a few years ago. It concluded that the risk of BSE appearing in this country was not very great. APHIS found that Britain had several risk factors not present here such as: a higher rate of scrapie in sheep; a higher ratio of sheep to cattle; a higher percentage of sheep meat and bone meal in rendered product (prior to bans in both countries); a greater reliance on animal protein in protein feed (prior to bans); and inclusion of meat and bone meal in calf starter feed (prior to bans).
Recently, several national livestock trade associations and veterinary organizations called for a voluntary ban on ruminant tissue in ruminant feed, but this voluntary ban is not yet in effect. It is opposed by trade associations representing the rendering industry and the feed industry.
The Food and Drug Administration has announced plans to make the "ruminant-to-ruminant" ban mandatory. It will "expedite regulations prohibiting all ruminant protein in ruminant feed." The exact scope of the ban will be determined in a notice-and-comment rulemaking. Promulgation of a final rule may take one year to 18 months, according to some reports. FDA had proposed a ban on adult sheep and goat tissue in ruminant feed back in 1994, but no action was taken.
CJD generally strikes elderly people and has an incubation period of from five to 30 years. The Centers for Disease Control and Prevention (CDC) does surveillance for CJD in the United States by analyzing death certificate information from multiple-cause-of-death mortality data. These data indicate that CJD mortality in the United States from 1979-1992 was relatively stable ranging from 0.8 cases per million in 1979 and 1990 to 1.1 cases per million in 1987. CDC is doing active surveillance for all emerging infectious diseases at four sites around the country—in Minnesota, California, Connecticut, and Oregon—and these sites will also begin looking for CJD.
If this theory is true, it would explain why TSEs produce no detectible immune response (i.e., production of antibodies) or inflammatory reaction in infected animals. Unlike bacteria or viruses which introduce foreign proteins into the body, prions are believed to depend on the infected animal's own proteins. Lacking foreign proteins, prions are invisible to the victim's immune system. Prions also appear to be extremely resistant to heat and normal sterilization processes.
Prion diseases can be inherited, can arise spontaneously, or can be transmitted infectiously. Most cases of CJD (excluding, perhaps, the recent cases in Britain) seem to occur as a result of spontaneous mutations of nerve cells. Other human forms of TSE, such as Gerstmann-Straussler-Scheinker disease, are inherited. Kuru (and, possibly, the recent CJD cases in Britain) are spread by eating infected tissue.
How are infectious prions able to cross the species barrier? No one knows, but Dr. Prusiner has theorized that it may depend on the degree of similarity in the amino acid sequence in the proteins of the two species and that the degree of similarity of certain parts of the amino acid sequence may be more important than others for determining whether the disease will cross the species barrier.
Mad Cow Disease, Bovine Spongiform Encephalopathy, or BSE is devastating the British beef industry, with serious ramifications for all meat eaters. It is a startlingly clear example of what can happen when we allow government scientists to secretly muck around with biologically hazardous substances.
Scrapie, a Spongiform disease of older sheep and goats, has been known for over two hundred years in western Europe. The animals become irritable, lose vision, rub themselves raw (hence Scrapie), and die. Scrapie is a variant of a disease known as Transmissible Spongiform Encephlopathy (TSE) which is now found in many different animals, including humans. TSE diseases cause central nervous system damage and the source of infection is probably a baffling disease agent known as a "prion" (pree-on).
Prions were first identified in 1980 by Dr. Stanley Prusiner at UCSF. Prions are proteins which contain no known genetic material, but they can act as extremely resistant infectious agents that slowly alter other protein molecules in the brain. Ordinary nerve cells produce proteins very similar to the mutant prions, so natural defenses are ineffective in halting the spread, once TSE has been successfully introduced into a susceptible organism. The healthy protein is transformed by the misshapen prion through a still unknown process into brain matter that resembles a sponge. Genetic susceptibility and exposure to pesticides may play a possible role in the spread of the TSE.
BSE was first diagnosed in British cows during April of 1985. "Officials" claimed that there was absolutely no danger in eating British beef. As a result infected material ended up in meat pies, cosmetics, and cattle feed. After thousands of cattle began dying of BSE in 1988, the government finally ordered measures to curtail dangerous practices, such as feeding cows other ground-up cows to improve milk productivity, and using offal (waste parts) for hot dogs and kidney pies,etc. But all this came too late; humans have now contracted the deadly Mad Cow disease.
The March 22, Sacramento Bee headline: "Deaths cause British panic over ŌMad Cow DiseaseÕ" was my first inkling of events just surfacing that would soon seriously affect the our worldÕs meat eating habits. The article mentioned the slump in beef prices, the Scrapie connection and "brain disease". American consumers were assured that " mad cow disease had never been detected in cattle in the U.S.".
After reading Emerging Viruses: Aids and Ebola by Leonard Horowitz, I decided to reexamine the BSE situation. In his thoroughly researched history of the AIDS and Ebola plagues, Horowitz vividly portrays the inept, dishonest and secretive science found in our countryÕs national laboratories and in international organizations such as the World Health Organization (WHO). These powerful networks control the direction of most medical research but never take responsibility for miscalculations and lapses in judgment. If we all really knew the truth about these irresponsible scientists, weÕd stop quarantining animals and start quarantining them.
WHO has been researching Scrapie since at least 1965 as a possible bio-warfare agent. In 1969 it reported that during the previous five years there had been a "recent interest in the "slow viruses", in particular those causing chronic degenerative disease of the nervous system- the CHINA viruses...progress has come from painstaking work with visna and Scrapie, degenerative diseases of the central nervous system, and Kuru, a degenerative disease of the central nervous system of man..."
The CHINA (chronic infectious neuropathic agents) viruses were inadequately understood at that time: "CHINA viruses are distinguished by the languishing character of the infection process they initiate. The incubation period in the host may be months or years, and the disease itself may progress laggardly towards an irreversible deterioration of the victim. Cells infected with "slow" viruses are in general neither impaired nor stimulated to proliferate. Their functions are impaired but the nature of the dysfunction has not yet been clarified...The resistance of the Scrapie agent to heat, ether, formalin, and other enzymatic and chemical agents, as well as its very small particle size, poses the question whether it is a conventional virus, an incomplete virus, or some other agent..."
If it hadnÕt been for Dr. Prusiner, WHO would still be looking for a "slow" virus. Until 1980, scientists didnÕt have a clue about prions; from 1964 on these folks were looking for a virus. To determine the nature of this "slow" virus, tissue cultures were made, infected and then injected into countless lab animals including cows, mice, hamsters and monkeys. The Department of Defense also began trying to develop "a new infective microorganism which could differ in certain important aspects from any known disease-causing organism." In 1970 the Army received a ten million dollar down payment toward the goal of developing a "super germ" like the AIDS virus that would inhibit or destroy the immune system, and weÕve all been keeping up the payments ever since.
Henrietta Lack died in 1965 of uterine cancer. She gained dubious immortality through the cells of her cancer for they were the first cancer cells to be grown in perpetuity in tissue cultures. Before HELA (Henrietta Lack) cells, only one or two divisions were possible. The HELA cells were sent world wide. ItÕs not well known but even during the peak of the "cold war", Soviet and U.S doctors were collaborating on bio-warfare and cancer virus research. In 1972 the Russians sent us six cell lines they thought contained cells with cancer causing viruses. As it turned out, these cell lines were all contaminated with HELA cells that contained monkey viruses.
Dr. Walter Nelson Reese had the responsibility of keeping the cell lines in the U.S. cataloged. After the incident with the Russians, he decided to examine all the cell lines. He discovered, much to his amazement, that over a third of them were HELA contaminated, probably when culture lids were opened and aerosolized particles would float around the lab and sometimes drop into another cell line. The aggressive HELA cells, often carrying viruses from other species,would soon take over a culture.
What are the long range consequences of such sloppy science? What new prion configuration is lurking in your next flu shot or Big Mac? While the USDA insists that our beef is safe and our cattle are free of BSE, they fail to divulge that a form of TSE is present in many domestic herds. How many is unknown at this time because blind denial on the part of the beef & dairy industry has blocked any attempt to realistically assess the problem.
Every year 300,000 of the 100,000,000 cattle reared in this country exhibit a set of strange symptoms. Known as "downers", the cattle become irritable and begin to stagger around. When put under stress, these poor creatures fall down and are unable to stand upright ; the animals waste away. USDA scientists know that "downer" is a TSE variant because "downer" meat, fed to minks, has led to outbreaks of a Spongiform Encephlopathy type disease, MSE. These TSE carrying "downers" are ground up and fed to other animals. There is no telling where prions can appear since they cannot be eradicated. TheyÕve been allowed access to humans and domestic animals for almost thirty years. Presently, more than 200,000 U.S. citizens die each year from misdiagnosed TSE caused diseases.
Is botched science responsible for the unsettling circumstances surrounding the recent explosion of Spongiform diseases? During the mid sixties the quest for a new "infectious agent" centered on the "slow virus" thought to be found in Scrapie and Kuru. I contend that our national labs have been clumsily contaminating their cultures with prions, just as they did with HELA cells. On top of that, fetal calf serum is still being used as a culture medium. Thinking it sterile, scientists never understood until recently that vertical transmission of the then unknown prion was possible. The slow nature of prion diseases has prolonged a misunderstanding of the problem and perhaps allowed prionsÕ entry into vaccines, and these vaccines have been put back into cows and you and me. The prions have begun to accumulate exponentially and weÕre left with the situation we have today- big trouble.
Can we rely on government scientists to cure our collective ills? Remember Dr. Walter Nelson Reese, the guy who warned his colleagues about the HELA contaminated cells? After pointing out the problems he uncovered, his laboratory was de-funded and Reese now operates an art gallery.
REFERENCES:
Leonard G.Horowitz, Emerging Viruses:AIDS and Ebola- Nature, Accident
or Genocide*
Prusiner S.B, "The Prion Diseases" Scientific American. Jan 1995
Richard Lacy, "How Now Mad Cow", 1995
Dr. Shaun Heaphy, "Prion Diseases"1996
Michael Greger, " Mad Cow Disease-Much More Serious Than AIDS"
James Wood, "Some Facts To Help Inform About BSE/CJD"
Larry Mark, "Bovine Spongiform Encephalopathy" USDA
* This book can be purchased directly from Len Horowitz -800-336-9266.
HeÕll be glad to answer any questions you may have. For those folks
really interested in the question of the many new "emerging viruses",
I suggest you read this brilliantly idiosyncratic volume.
My other references were downloaded from sites on the World Wide Web.