RE: Docket No: 01-064-1

USDA Report on Animal Disease Risk Assessment, Prevention and Control Act of 2001 (Bovine Spongiform Encephalopathy - BSE)

S.T.O.P. - Safe Tables Our Priority is a national nonprofit, grassroots organization consisting of victims of foodborne illness, family, friends and concerned individuals who recognize the threat pathogens pose in the U.S. food supply.  Many of our members have had loved ones maimed or killed by pathogens, including E. coli O157:H7 in meat, produce, and unpasteurized apple juice; Salmonella in unpasteurized orange juice and poultry, Vibrio vulnificus in oysters, Campylobacter and Listeria.   S.T.O.P.'s mission is to prevent unnecessary illness and loss of life from pathogenic foodborne illness.

We greatly appreciate the opportunity to comment on current governmental progress toward prevention of BSE and related diseases.  We have attached a speech we have given at a previous public meeting on BSEs.

BACKGROUND

Present U.S. policy at USDA and FDA toward the prevention of the spread of TSE's to American consumers demonstrates a lack of commitment to complete prevention.   Rather than erect all formidable barriers already erected in countries affected by BSE, the U.S. has too slowly developed a kind of patchwork, on-the-fence, compromise policy that is guaranteed to fail in the face an immediate threat to the system.  Unfortunately for both the public and the meat industry, by the time that challenge would be identified, it would be too late.  Owing to the massive scale of food production in the United States in comparison with other countries where the disease has so far been identified, failure in this instance would mean infection of potentially tens of thousands of people, the collapse of consumer confidence in U.S. meat production, and a worldwide drought of demand for U.S. meat. 

At this point in time, while TSE's are the only confirmed diseases transmitted by food consumption, U.S. health authorities cannot say with certainty how many other seemingly sporadic, neurologically degenerative diseases might also be transmitted in this way.  Not only do Americans already suffer from existing sporadic cases of èclassicî CJD, but we have hundreds of thousands of other patients suffering from costly, chronic, debilitating diseases such as MS and Alzheimer's with symptoms similar to those of TSEs.  The costs of these diseases, and the fact that steps taken to reduce TSEs may well prevent a percentage of these diseases should be taken into account in risk analysis and economic analysis of TSE prevention measures.

URGENTLY NEEDED ACTIONS

In the meantime, S.T.O.P. - Safe Tables Our Priority strongly urges USDA and FDA to immediately put in place, through emergency rulings, all measures adopted by countries that have already been affected by this disease, as well as others that are necessary for the coordination of recalls and notification of the public:

1) (USDA) A ban on meat-on-the-bone. 

2) (USDA) The removal of the spinal column in slaughtering with no further processing.  The U.S. should aggressively seek to eliminate all potentially contaminated spinal cord material from meat production.

3)  (FDA) Finalization of rules and enforcement of the full EU ban on feeding "processed animal protein to animals which are kept, fattened or bred for the production of food, including all meat-and-bone meal products.   This rule is essential to keeping BSE from gaining a toehold in the U.S. cattle industry, and is readily implementable in a country where soy protein is available for animal feed consumption.

4)  (FDA's CFSAN) Creation of a gelatin "sourcing" rule and enforcement of it.  This rule should not pussy foot around distinctions such as gelatin can be derived from BSE-free herds, when no one is entirely certain if a herd is BSE free.  Gelatin raw materials, at a minimum, should be prohibited from any country known to have BSE.  The current guidance has existed for almost 4 years; a regulation is long overdue.  Guidelines are insufficient when regulations are not even followed due to lack of enforcement.

5)  (FDA) Implementation of a rule that dietary supplement manufacturers carry warning labels on their products if those products contain suspect animal parts, and the label should also reveal the country from which they are sourced.   FDA must also prepare to implement recalls of such products as new reveal BSE in their herds.

6) (FDA) A mandatory, national registration program for manufacturers of dietary supplements, gelatin manufacturers, and dairies.  FDA must equip itself with the ability to quickly notify ALL manufacturers potentially affected by TSE.  This is merely the first line of defense in a true readiness campaign to act against this disease.  Issuing press releases is wholly insufficient for notifying food processors.

7) (FDA) Development of country-of-origin meat labeling to ensure that American consumers consuming mammalian meat in restaurants and grocery stores are notified as to the country of origin of that meat.  With the list of BSE infected countries or countries with suspect feed practices exploding, consumers deserve to be able to make informed choices about the meat they eat.

8) Lastly, the final report must fully disclose how many American consumers, living in the United States, have been exposed to the risk of BSE, through the combination of delay, insufficient guidance, and inadequate enforcement as well as the misunderstanding of how widespread the problem has been overseas.  Americans deserve to know the range of true public health costs associated with delay and incomplete barriers.

IN CONCLUSION

USDA and FDA have available to them the science available in the UK and the EU.  Public comments reiterating the available science should not be required to support the position that the U.S. should immediately put in place the same safeguards already established in other countries. 

As part of USDA's final report responding to the Animal Disease Risk Assessment, Prevention and Control Act, USDA should create a table illustrating the differences between current US policy, European Union policy and UK policy so that the information is readily available to members of Congress, the White House and consumers.  Cost of implementation of the rules the U.S. has NOT yet put in place should be included, along with the cost in human lives, medical support, consumer confidence, etc. under the assumption that the U.S. is not successfully shielded from TSEs.

S.T.O.P. - Safe Tables Our Priority looks forward to a re-energized, collaborative campaign on the part of all the governmental agencies working on prevention of BSE to successfully defend the public's health from this threat.

Sincerely,

Laurie Girand

Co-President

Janet Abrams, Representative

S.T.O.P. Safe Tables Our Priority

Speech at the FDA Consumer Briefing on BSE
4/16/01

S.T.O.P. - Safe Tables Our Priority is a national, non-profit organization of victims of foodborne illness and many consumers concerned about pathogens in our food supply.  S.T.O.P.'s mission is to prevent unnecessary illness and death from foodborne illness. We appreciate the opportunity FDA has offered today for us to submit comments on behalf of past victims of foodborne illness and consumers concerned about TSE.

I am also here today to represent Americans who will die in the future from new variant Creutzfeld Jakob disease.  Though we don't know who they are yet, Americans WILL DIE from this disease, even if they do not become infected on American soil.   People who traveled abroad over the last 10 years, people who relocated to Europe for work, or even members of our armed services or diplomatic core, stationed overseas in the 1990's, all represent American populations presently at risk of developing this disease.

I want to remind FDA's representatives as well of the hundreds of thousands of Americans who suffer already from debilitating neurologic disorders that may someday be proven to be caused in a manner similar to new variant Creutzfeld Jakob disease.  FDA needs to be mindful that if one neurologic disease can be transmitted in this fashion, others might certainly take advantage of a similar pathway.

S.T.O.P.'s  message to you should be clear: USDA's and FDA's present precautions are not adequate to prevent transmissible neurologic diseases from gaining a foothold in our country.   FDA's and USDA's delayed action and sporadic, incrementally-raised barriers renders the  public's health vulernable to this menace.  We do not have to wait for TSE to come to the United States.  It is already here in sheep and both wild and domestic elk and deer herds(y).  It merely simmers, awaiting an opportunity to jump species barriers and be amplified through mass agribusiness practices and poorly enforced regulations just as other diseases such as E. coli O157:H7 and Salmonella have already done.  It is essential to act agressively NOW.

We offer several examples of dangerous delays that put industry interests ahead of those of public health and safety in feed, gelatin, and dietary supplements.

In 1988, the UK introduced a ban on feeding ruminant protein to ruminants.  This was expanded in 1994 to be a ban on feeding mammalian protein to ruminant species.  In 1996, this ban was again expanded to prohibit mammalian meat and mammalian bone meal to all farmed livestock.  These rules were again superseded in the year 2000, when the UK instituted a temporary ban through June, 2001 on the feeding of processed animal protein to animals grown for human consumption.(v)

In contrast, in 1997, the FDA's Center for Veterinary Medicine finalized a rule prohibiting the feeding of mammalian protein to ruminant animals in most cases.(z)  This rule, which lagged behind its UK counterpart by 3 years had already been set aside as too minimal. Following the rule, FDA then proceeded to take more than 3 years to perform inspections to verify that renderers and feed mills were in compliance.   As of March 23, 2001, inspections have revealed that 14% of U.S. renderers do not have a system for preventing commingling.  13% of FDA licensed mills do not have a system to prevent commingling, and 18% of Non FDA licensed mills do not have a system to prevent commingling.  For feed, FDA has regulations but does not rapidly enforce them.  Instead, reinspection continues and U.S. cattle and consumers continue to serve as guinea pigs. 

(pause)

Gelatin is a food product typically derived from the long bones and hides of farm mammals including cattle.  In 1994, based on very preliminary data, FDA's CFSAN exempted gelatin from the USDA ban on importing bovine materials from countries known to have BSE (x).  In 1997, based on new data, FDA reversed its 1994 decision and developed guidelines for industry.  FDA merely suggests that gelatin manufacturers should avoid using inputs from BSE herds, though they might still source gelatin inputs from BSE countries.  It is unconscionable  that there are still no regulations on prohibiting bovine materials from identified or suspect countries to be used in gelatin, a product used to create candy and jello for children.

(pause)

In 1992 and 1994, CFSAN wrote letters to some manufacturers of dietary supplements, that included bovine body parts such as the adrenal and pituitary glands.  These letters advised that the manufacturers investigate the sources of their materials and not use materials from BSE-countries, as identified by APHIS.(x)   The number of countries with insufficient surveillance for BSE has risen considerably since 1992 when FDA first wrote letters, and yet FDA still does not have rules prohibiting the use of bovine and ovine sourced materials in dietary supplements.

Here is what S.T.O.P. urges the FDA to do:

1)  FDA's Center for Veterinary Medicine must immediately finalize rules and enforce the full EU ban on feeding "processed animal protein to animals which are kept, fattened or bred for the production of food".   This rule is essential to keeping BSE from gaining a toehold in the U.S. cattle industry.

1)  FDA's CFSAN must immediately create a gelatin "sourcing" rule and enforce it.  This rule should not pussy foot around distinctions such as gelatin can be derived from BSE-free herds, when no one is entirely certain if a herd is BSE free.  Gelatin raw materials, at a minimum, should be prohibited from any country known to have BSE.  The current guidance has existed for almost 4 years; a regulation is long overdue.  Guidelines are insufficient when regulations are not even followed due to lack of enforcement.

3)  While FDA's CFSAN works toward regulations prohibiting the use of animal parts in dietary supplements, FDA must immediately implement a rule that dietary supplement manufacturers carry warning labels on their products if those products contain suspect animal parts, and the label must also reveal the country from which they are sourced.   FDA must also prepare to implement recalls of such products as new reveal BSE in their herds.

4) FDA must immediately put into place a mandatory, national registration program for manufacturers of dietary supplements, gelatin manufacturers, and dairies.  FDA must equip itself with the ability to quickly notify ALL manufacturers potentially affected by TSE.  This is merely the first line of defense in a true readiness campaign to act against this disease.  Issuing press releases is wholly insufficient for notifying food processors.

5) FDA must ensure that American consumers consuming mammalian meat in restaurants and grocery stores are notified as to the country of origin of that meat.  With the list of BSE infected countries or countries with suspect feed practices exploding, consumers deserve to be able to make informed choices about the meat they eat.

6) Lastly, FDA must fully disclose how many American consumers, living in the United States, have been exposed to the risk of BSE, through the combination of delay, insufficient guidance, and inadequate enforcement as well as the misunderstanding of how widespread the problem has been overseas.  Americans deserve to know the range of true public health costs associated with delay and incomplete barriers.

If there is only one lesson to be learned from the disastrous consequences of the infection of UK and European farm animals,  it is that FDA and USDA must get ahead of the science.  As long as U.S. government officials continue to act as though BSE is not here yet, we will have slow and lax regulation and enforcement.  The results could be devastating.  We ask that FDA erect all formidable barriers to amplification of transmissible neurologic diseases in the year 2001.  Without them, you cannot possibly continue to say that the U.S. food supply is among the safest in the world.   Instead, we are all sitting ducks.

We thank you for your time.