POSITION ON FDA'S PREVENTION EFFORTS TOWARD BSE TO DATE (4/16/2001)

Delivered by Janet Abrams
S.T.O.P. - Safe Tables Our Priority
FDA Consumer Briefing on BSE
Washington, DC
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.

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.

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.