A CLOSER LOOK: BIOTECH ANIMALS
Genetically engineered animals and the FDA Are genetically engineered fish and meat coming soon? We examine the Food and Drug Administration's regulations.
By Jill U. Adams January 26, 2009
Fast-growing salmon. Pork containing heart-healthy omega-3 fatty acids. These are two examples of products you might see in your local supermarket soon -- animals developed not through conventional breeding but through genetic engineering.
On Jan. 15, the U.S. Food and Drug Administration decided how it will regulate genetically engineered animals, for the first time paving the way for such animals or their products to be sold as food and medicine. The agency has decided to categorize genetically engineered farm animals, also called transgenic animals, as an "animal drug." They will be held to the same requirements already existing for conventionally bred animals treated with hormones or antibiotics. (In the case of transgenic animals, the "drug" is a snippet of DNA.) Products derived from them or containing them as an ingredient will not necessarily require labeling.
A wide range of interested parties, including companies developing genetically engineered animals and consumer protection groups, are generally comfortable with the FDA decision. And yet, consumer acceptance of transgenic animals, particularly as food products, is still an unknown.
American consumers have been eating food from genetically engineered crops, such as corn, soybeans and canola, for a decade. However, transgenic animals have not been sold, pending the FDA deliberations on how to regulate them.
Why would someone want to genetically engineer animals?
Genetic engineering is a high-tech way to "breed" desirable traits into livestock. The benefits might be for the producer, such as a disease-resistant cow or an easy-to-raise salmon. It might be for the environment -- pigs that produce milder manure, for example -- or for the consumer, say, more nutritious meat.
The old-fashioned way of breeding farmed animals requires selecting offspring with desired traits over successive generations. Ron Stotish, chief executive of Aqua Bounty Technologies in Waltham, Mass., says the power of genetic engineering is that the same end is achieved in "one fell swoop." Transgenic animals also can be fitted with traits they probably would never develop naturally, as in the case of omega-3-producing pigs.
How is an animal genetically engineered?
An extra piece of genetic material (DNA) is inserted into the animal's genome at the earliest stages of development. Sometimes the method involves manipulating a fertilized egg that is then implanted into a surrogate mother; other times, it alters a cell from which an animal will be cloned. As the embryo grows, the DNA splice is replicated with the rest of the genetic material so that it ends up in every cell of the individual.
In fast-growing salmon developed by Aqua Bounty, the inserted gene is a salmon growth hormone, identical to the one the fish have naturally. The benefit comes from the precise placement of the added gene, which makes it active at times that the natural gene is not. "Normal salmon grow very, very slowly, and when it is cold they don't grow at all," Stotish says. "Our gene is active under a broader range of conditions and it allows the animals to grow." At 1 year old, a normal salmon might weigh 30 grams, but the transgenic fish weigh a kilogram, he says.
In pigs developed to contain omega-3 fatty acids, the added gene directs formation of an enzyme that converts naturally occurring omega-6 fatty acids to omega-3s. The gene is derived from tiny roundworms but is modified to make it more mammalian, says Randall Prather, co-director of the National Swine Resource and Research Center at the University of Missouri in Columbia, who developed these pigs.
Why did the FDA opt to regulate genetically engineered animals in this manner and what criteria are used to assess safety?
The FDA is responsible for food safety and already regulates genetically modified crops. By considering a DNA segment a drug, the agency will regulate transgenic animals in the same way it oversees dairy cows that receive growth hormone or beef cattle that get antibiotics, says FDA spokeswoman Siobhan DeLancey.
By using existing guidelines for so-called animal drugs, the FDA can put those products seeking approval into a process that is already up and running. "They have the staff and the process that allows them to look at this. They do it every day," says Stotish of Aqua Bounty, which has been seeking FDA approval for its fast-growing salmon for years.
Companies must show that their genetic manipulation is safe to the animal and that any food or animal-feed products derived from the animal are safe for the consumer and safe for the environment. Companies must also demonstrate that their claims about the gene-carried traits do occur.
Are there concerns beyond what the FDA can regulate?
Gregory Jaffe, who follows biotechnology for the consumer advocacy group Center for Science in the Public Interest, says the adopted guidelines are a good start "in the sense that the federal government has acknowledged that these animals are on the horizon and there needs to be oversight to ensure their safety."
But, he adds, genes are not the same as drugs. Drugs may have long-lasting effects on an individual, but they wouldn't get passed on to future generations. In the case of biotech animals, however, "you're altering the DNA of that animal, which gets carried on to its offspring." (Aqua Bounty says all the fish it markets will be sterile.)
Such lasting effects may have implications for preventing escape of the genes to natural populations, Jaffe says -- an issue that is beyond the FDA's expertise or authority.
Jaffe thinks the safety review should be more open and transparent. "Our regulatory processes for drugs" -- including animal drugs -- "are, on the whole, secret and done behind closed doors," he says. By law, the company controls what information is made public.
Other regulatory processes, such as those for pesticides at the Environmental Protection Agency, have been opened in past decades to invite public participation.
"Genetically engineered animals are highly controversial," Jaffe says. "I think that they [the FDA] need to have a transparent and participatory regulatory system -- where the public can review safety data and . . . expert scientists can provide comments to the agency."
Why did the FDA decide that food from genetically engineered animals doesn't have to be labeled?
The FDA labels food based on nutritional content, not manufacturing process, says the agency's DeLancey.
"So, if the food product is 'materially different' from a conventional product, then FDA can require that it be labeled. But the FDA doesn't require that a pork chop label specify whether it came from a pig produced through artificial insemination versus conventional breeding."
And similarly, now, if it came from genetically engineered animals. "We understand that consumers want transparency and labeling, but we are constrained by the regulations put in place by Congress," DeLancey says.
How will I know if the food I buy is from genetically engineered animals?
Pork from an omega-3 pig, should it gain approval, will be labeled because nutritional enhancement is a selling point -- and because the product is different from regular pork.
In other cases you may not know, although producers can voluntarily label their products. Researchers at the University of Guelph in Canada, who developed the so-called Enviropig with "greener" manure, say they intend to do so.
The U.S. Department of Agriculture has guidelines for labeling "natural meats," which would allow meat from non-transgenic animals to call attention to that fact.
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:health@latimes.com
http://www.latimes.com/features/health/la-he-closer26-2009jan26,0,1632723.story
Tuesday, July 29, 2008
Docket No. 2005N-0373 RIN number 0910-AF54 Use of Materials Derived From Cattle in Medical Products REOPENING COMMENT PERIOD Date: March 30, 2007 at 11:37 am PST
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TSS SUBMISSION TO ;
Docket No. 2005N-0373 and RIN number 0910-AF54
Greetings FDA et al, ONCE again I would kindly like to comment on the continuous failed attempts by the FDA to regulate the use of certain cattle material in, or in the manufacture including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants) from the proven risk factors of Transmissible Spongiform Encephalopahy i.e. TSE's in all species. I have continued to warn the FDA et al about these risk factors via the surgical and medical arena (vaccines, nutritional supplements, bovine heart valves, and other animal donor tissue), and I have continued to point out the risk factor of the UKBSENVCJD only theory, and the ramifications there from, i.e. BASE (bovine amyloidotic spongiform encephalopathy), and my greatest fears, one I have warned you about time and time again, seems to be coming true ;
64. A member noted that at the recent Neuroprion meeting, a study was presented showing that in transgenic mice BSE passaged in sheep may be more virulent and infectious to a wider range of species than bovine derived BSE. Other work presented suggested that BSE and bovine amyloidotic spongiform encephalopathy (BASE) MAY BE RELATED. A mutation had been identified in the prion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO A MUTATION FOUND IN CASES OF SPORADIC CJD. A study also demonstrated that in a mouse model it was possible to alleviate the pathological changes of prion disease by suppressing expression of the prion protein gene after infection.
http://www.seac.gov.uk/minutes/95.pdf
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full text ;
http://madcowfeed.blogspot.com/2008/07/docket-no-2005n-0373-and-rin-number.html
http://madcowfeed.blogspot.com/2008/12/docket-no-fda2008d0597-draft-guidance.html
Tuesday, April 29, 2008
Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency
----- Original Message -----
From: "Terry S. Singeltary Sr." mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:flounder9@verizon.net
To: "Bovine Spongiform Encephalopathy" mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:BSE-L@aegee.org Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:heggem.daniel@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:sibert.christopher@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:denne.jane@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:hazen.susan@epa.gov; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:mcrosby@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:erobinson@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:enegin@ucsusa.org; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:cjdvoice@yahoogroups.com; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:madcow@lists.iatp.org
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) has the simple yet profound charge "to protect human health and the environment." EPA scientists apply their expertise to protect the public from air and water pollution, clean up hazardous waste, and study emerging threats such as global warming. Because each year brings new and potentially toxic chemicals into our homes and workplaces, because air pollution still threatens our public health, and because environmental challenges are becoming more complex and global, a strong and capable EPA is more important than ever.
Yet challenges from industry lobbyists and some political leaders to the agency's decisions have too often led to the suppression and distortion of the scientific findings underlying those decisions—to the detriment of both science and the health of our nation. While every regulatory agency must balance scientific findings with other considerations, policy makers need access to the highest-quality scientific information to make fully informed decisions.
Concern over this problem led the Union of Concerned Scientists (UCS) to investigate political interference in science at the EPA. The investigation combines dozens of interviews with current and former EPA staff, analysis of government documents, more than 1,600 responses to a survey sent to current EPA scientists, and written comments from EPA scientists.
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations. ...
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Interference at the EPA Science
http://sciencebushwhacked.blogspot.com/
Thu Dec 6, 2007 11:38
FDA IN CRISIS MODE, AMERICAN LIVES AT RISK
http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html
FDA SCIENCE AND MISSION AT RISK
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf
Monday, January 12, 2009
FDA scientists complain to Obama of 'corruption'
http://sciencebushwhacked.blogspot.com/2009/01/fda-scientists-complain-about.html
January 26, 2009
A kind greetings from Bacliff, Texas !
O.K., let us suppose the impossible, that indeed spontaneous Transmissible Spongiform Encephalopathy _does_ exists (to date, this has never been proven in the field, under natural conditions), at whatever rate they choose (i do not believe in the spontaneous TSE as the cause for 85%+ of all CJD i.e. the sporadic CJD's, i.e. that all these poor victims died from a 'happenstance of bad luck', or 'that a twisted funked out protein just chose this group on it's own, with no route and source of nothing involved'), BUT for now, lets say they exist.
PLEASE tell me then how a GM cow will be free from the spontaenous TSE ???
Spontaneous occurrence (14-16)
The evidence from the absence of BSE in many countries and the surveillance schemes abroad indicates that most BARBs cases cannot have arisen spontaneously, although the possibility cannot be excluded that a very few of them did so. The possibility of a very low frequency of spontaneous occurrence of BSE may be monitored from the output of surveillance in cattle populations elsewhere. R: A watching brief is kept on surveillance efforts world-wide.
http://www.defra.gov.uk/animalh/bse/pdf/hillreport.pdf
Perspectives BIOMEDICINE: A Fresh Look at BSE Bruce Chesebro*
Mad cow disease, or bovine spongiform encephalopathy (BSE), is the cattle form of a family of progressive brain diseases. These diseases include scrapie in sheep, Creutzfeldt-Jakob disease (CJD) in humans, and chronic wasting disease (CWD) in deer and elk. They are also known as either "prion diseases" because of the association of a misfolded cellular prion protein in pathogenesis or "transmissible spongiform encephalopathies" (TSEs) because of the spongelike nature of the damaged brain tissue (1).
The recent discovery of two BSE-infected cows, one in Canada and one in the United States, has dramatically increased concern in North America among meat producers and consumers alike over the extent to which BSE poses a threat to humans as well as to domestic and wild animals. The European BSE epidemic of the late-1980s seems to have been initiated a decade earlier in the United Kingdom by changes in the production of meat and bone meal (MBM) from rendered livestock, which led to contamination of MBM with the BSE infectious agent. Furthermore, the fact that UK farmers fed this rendered MBM to younger animals and that this MBM was distributed to many countries may have contributed to the ensuing BSE epidemic in the United Kingdom and internationally (2).
Despite extensive knowledge about the spread of BSE through contaminated MBM, the source of BSE in Europe remains an unsolved mystery (2). It has been proposed that BSE could be derived from a cross-species infection, perhaps through contamination of MBM by scrapie-infected sheep tissues (see the figure). Alternatively, BSE may have been an endemic disease in cattle that went unnoticed because of its low level of horizontal transmission. Lastly, BSE might have originated by "spontaneous" misfolding of the normal cellular prion protein into the disease-associated abnormal isoform (3), which is postulated to be the infectious agent or "prion."
Five possible sources of BSE in North American cattle. Sheep, deer, and elk could spread prion diseases (TSEs) to cattle through direct animal contact or contamination of pastures. Endemic BSE has not been proven to exist anywhere in the world, but it is difficult to exclude this possibility because of the inefficient spread of BSE infectivity between individual animals (2). BSE caused by spontaneous misfolding of the prion protein has not been proven. CREDIT: KATHARINE SUTLIFF/SCIENCE
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Nevertheless, the idea that BSE might originate due to the spontaneous misfolding of prion proteins has received renewed interest in the wake of reports suggesting the occurrence of atypical BSE (9-11). These results imply that new strains of cattle BSE might have originated separately from the main UK outbreak. Where and how might such strains have originated? Although such rare events cannot be studied directly, any number of sources of the original BSE strain could also explain the discovery of additional BSE strains in cattle (see the figure). However, it would be worrisome if spontaneous BSE were really a valid etiology because such a mechanism would be impossible to prevent--unlike other possible scenarios that could be controlled by large-scale eradication of TSE-positive animals.
Another way to look at this problem is to examine evidence for possible spontaneous TSE disease in other animals besides cattle. Spontaneous BSE would be extremely difficult to detect in cattle, where horizontal spread is minimal. However, in the case of the sheep TSE disease, scrapie, which spreads from ewes to lambs at birth as well as between adults, spontaneous disease should be detectable as new foci of clinical infection. In the early 1950s scrapie was eradicated in both Australia and New Zealand, and the mainland of both these countries has remained scrapie-free ever since. This scrapie-free status is not the result of selection of sheep resistant to scrapie because sheep from New Zealand are as susceptible as their UK counterparts to experimental scrapie infection (12). These experiments of man and nature appear to indicate that spontaneous clinical scrapie does not occur in sheep. Similarly, because CWD is known to spread horizontally, the lack of CWD in the deer or elk of eastern North America but its presence in western regions would also argue against a spontaneous disease mechanism. This is particularly noteworthy in New Zealand, where there are large numbers of deer and elk farms and yet no evidence of spontaneous CWD. If spontaneous scrapie does not occur in sheep or deer, this would suggest that spontaneous forms of BSE and sporadic Creutzfeldt-Jakob disease (sCJD) are unlikely to be found in cattle or humans. The main caveat to this notion is that spontaneous disease may arise in some animal species but not others. In humans, sCJD--which is considered by some researchers to begin by spontaneous misfolding of the prion protein--usually takes more than 50 years to appear. Thus, in animals with a shorter life-span, such as sheep, deer, and cattle, an analogous disease mechanism might not have time to develop.
What can we conclude so far about BSE in North America? Is the BSE detected in two North American cows sporadic or spontaneous or both? "Sporadic" pertains to the rarity of disease occurrence. "Spontaneous" pertains to a possible mechanism of origin of the disease. These are not equivalent terms. The rarity of BSE in North America qualifies it as a sporadic disease, but this low incidence does not provide information about cause. For the two reported North American BSE cases, exposure to contaminated MBM remains the most likely culprit. However, other mechanisms are still possible, including cross-infection by sheep with scrapie or cervids with CWD, horizontal transmission from cattle with endemic BSE, and spontaneous disease in individual cattle. Based on our understanding of other TSEs, the spontaneous mechanism is probably the least likely. Thus, "idiopathic" BSE--that is, BSE of unknown etiology--might be a better term to describe the origin of this malady. ...
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http://www.sciencemag.org/cgi/content/full/sci;305/5692/1918
Release No. 0106.04
Contact: Office of Communications (202) 720-4623
Transcript of Remarks From Technical Briefing on BSE and Related Issues With Agriculture Secretary Ann M. Veneman and USDA Chief Veterinary Officer Dr. Ron DeHaven Washington D.C. - March 15, 2004
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OPERATOR : “Yes. Our next one is coming from Elizabeth Weiss. Please state your company.”
ELIZABETH WEISS: “This is Elizabeth Weiss with USA Today.”
“I actually had two questions. First off, when you say you're looking for 1 in 10,000 cases, is USDA doing any work to find out the possibility of whether or not BSE exists in a spontaneous form in the way that it does in humans and elk populations?
“And secondly, how will any of this fit into some of the consternation that's been raised in California and with the Midwest packer that wanted to test all of its cattle?
“Thanks.”
DR. DEHAVEN: “All right. I think we've got three different questions in there, and I'll try to touch on each one of them.
“First of all, let me correct just a technical issue, and that is you mentioned 1 in 10,000. And actually our surveillance system currently is designed, the one that we have in place now is designed to detect 1 positive in 1 million cattle, and I gave some numbers between 200,000 and 268,000 that would allow us to detect 1 in 10 million as opposed to 1 in 10,000.
“So we would, if we were able to collect in the ballpark of those numbers of samples then we with increasing numbers of samples have an increasingly statistically valid sample from which to determine, one, whether or not the disease exists and, if so, at what prevalence level.
“So our real emphasis is to test as many of those animals as we can, ensure that we get an appropriate geographical distribution, but not setting a specific number as far as a target. Again, consistent with the recommendation from the International Review Team, their recommendation was to test all of them.
“So that's consistent with where we're going is to test as many as we possibly can.
“As far as spontaneous cases, that is a very difficult issue. There is no evidence to prove that spontaneous BSE occurs in cattle; but here again it's an issue of proving a negative. We do know that CJD, the human version of the disease, does occur spontaneously in humans at the rate of about 1 in 1 million. We don't have enough data to definitively say that spontaneous cases of BSE in cattle occur or do not occur.
“Again, it's a very difficult situation to prove a negative.
“So a lot of research is ongoing. Certainly if we do come up with any positive samples in the course of this surveillance we will be looking at that question in evaluating those samples but no scientifically hard evidence to confirm or refute whether or not spontaneous cases of BSE occur.
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http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?contentidonly=true&contentid=2004/03/0106.html
UK TESTING FINISHED NEXT WEEK
Matthews confirmed that the brain tissue samples from the US animal had arrived at Weybridge. Test results were likely to be ready by the end of next week, he said.
The suspect animal has already undergone a series of tests. A rapid screening test on Nov. 15 returned inconclusive results. Sophisticated immunohistochemistry (IHC) tests cleared the animal of any infection, but a third round of testing using a Western blot procedure showed a "weak positive".
Weybridge will do an IHC test plus three kinds of Western Blot tests on the samples. They will use "methods of slightly different analytical sensitivity that give us the greatest number of opportunities to interpret what we see," he said.
US beef industry leaders say scientists should not speculate about the unusual case.
"There's no evidence that it's atypical ... and there's absolutely no evidence that it's spontaneous," said Gary Weber, head of regulatory affairs at the National Cattlemen's Beef Association.
Matthews noted scientists are still grappling with what is typical and atypical BSE.
"Far too few people have looked at BSE in depth using all of the tests to be able to define 'this is normal and that one isn't'," he said.
Weber noted Japan used the term to describe two very young infected cattle because BSE is usually found in older animals. Italy labeled a case "atypical" because the misshaped prions were found in unexpected parts of the animal's brain. ...snip...end
http://www.agobservatory.org/headlines.cfm?refID=73207
Atypical BSE strain -- In July 2007, the UK Spongiform Encephalopathy Advisory Committee (SEAC) suggested that atypical BSE may be a distinct strain of prion disease. Unlike typical BSE, cases of atypical BSE, according to SEAC, may have risen spontaneously (although transmission through feed or the environment cannot be ruled out). Recently reported French surveillance data support this theory that unlike typical BSE, atypical BSE appears to represent sporadic disease
http://cdc.gov/ncidod/dvrd/bse/
http://www.defra.gov.uk/animalh/bse/pdf/hillreport.pdf
Spontaneous occurrence
14. Spontaneous cases of classical CJD in humans are found at a rate of about 1/million around the world (Will, 1993), without appreciable racial or geographical variation except in a few specific cases, notably Jews of Libyan origin that have a mutation in the open reading frame of the PRNP gene (Chapman and Korczyn, 1991). Thus it is theoretically possible that spontaneous cases of BSE could occur as a consequence of a germ line mutation, in which case relatives would also have a certain or increased incidence of the disease, or a somatic mutation, which would be unlikely to be detectable unless the appropriate tissue were identified, or after some transformation in the PrP protein in the animal concerned. BSE was unknown prior to its detection in Britain in the mid 1980s, and Index cases found around the world since then can all be explained in terms of export from the UK directly or indirectly of cattle or of feed components. No BSE affected animals have been reported in many developed countries with large cattle populations, including Australia, New Zealand, Norway and Sweden, which have mixed cattle populations; and the only infected animal detected in the US was of Canadian origin. The disease seems to have a highly homogeneous aetiology (e.g. Bruce, 2003).
15. Data from the USA, where the dairy population in particular is highly related to that in GB provide an upper limit to the spontaneous rate. A programme of testing is in place of a target population of adult cattle exhibiting some clinical sign that might be consistent with BSE (animals reported as having CNS or clinical signs of BSE or were non-ambulatory). In the intensive programme from June 2004 over 375000 animals were tested in the following 12 months. No positive results have yet been obtained in these or previous tests (USDA BSE Testing). This implies a putative upper limit of under 10 per million in this target group. Assuming, as analysis has shown, the relative risk in this group is about 30 times higher than in the population as a whole (European Commission, 2002c), then the incidence in the population as a whole is under 3 per 10 million. This figure could possibly be biased downwards if affected animals are diagnosed and disposed of without being tested. Taking account of testing done and the lack of clinical cases seen in many other countries also, it seems highly unlikely that the spontaneous rate can be as much as 3 per 10 million head. Nor can spontaneous occurrence explain incidences of ca. 30 cases of BARBs per year in 2002/4 in the UK adult cattle population of ca. 4 million. [NOTE ADDED 30 JUNE: The recent confirmation of a previously inconclusive case in the USA affects these calculations. If the animal did not have access to infected feed, the calculations have to be revised: they suggest a sporadic incidence in the population of 1/(375000 x 30) or almost 1 per 10 million, with the upper limit under 5 per 10 million.]
16. Calculation of a maximum rate of possible transformation from scrapie to BSE is less feasible. Nevertheless, BSE appears not to have arisen in the UK until around the early 1980s, despite the presence of scrapie in sheep here for at least 200 years. Although a change in the scrapie prion may have been the cause of the initial cases of BSE, the difference between their properties in mice and the uniformity of the BSE brain lesions suggest it is unlikely that more than one such mutation was the source of BSE. It is most unlikely that the same mutation could be occurring often enough to contribute significantly to BARBs cases. Furthermore BARBs cases do not match the geographical distribution of the sheep population. The evidence from the absence of BSE in many countries and the surveillance schemes abroad indicates that most BARBs cases cannot have arisen spontaneously, although the possibility cannot be excluded that a very ...
http://www.defra.gov.uk/animalh/bse/pdf/hillreport.pdf
242 Atypical and classical BSE are different strains based upon Western blot profiles 243 (Hill, 2004; Normile, 2004; Baron et al., 2006), and this study indicates that disease Page 11 of 23 Journal of Animal Science Downloaded from jas.fass.org by on November 12, 2008. 12 progresses via different routes for these strains. The disparate 244 routes of pathogenesis in 245 atypical BSE can occur by 1 of 2 means. One possibility is that the source of infectivity 246 in atypical BSE is exposure to contaminated feedstuffs, as is the case for classical BSE, 247 but progression occurs in a disparate manner that bypasses the influence of the indel 248 polymorphisms. The other possibility is that atypical BSE is occurring spontaneously in 249 the host. Support for atypical BSE occurring spontaneously are the parallels to sporadic 250 TSE in humans, specifically, occurrence in older hosts and a comparable low incidence 251 rate (Baron and Biacabe, 2006). Furthermore, atypical BSE occurs as isolated, sporadic 252 cases in contrast to the clustering of cases observed for feed borne classical BSE 253 (Donnelly et al., 1997). Interestingly, the only native born cases of BSE in the United 254 States identified to date have been classified as atypical BSE.
255 No experiment can conclusively confirm a spontaneous nature for atypical BSE.
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http://jas.fass.org/cgi/reprint/jas.2007-0208v1.pdf
Monday, February 11, 2008 7:00 am Registration and Morning Coffee
Emerging Concerns: De novo Formation of Prions
9:05 De novo Generation of Prion Infectivity in a Cell-Free System Joaquin Castilla, Ph.D., Assistant Professor, Department of Infectology, Scripps Research Institute-Florida Transmissible spongiform encephalopathies (TSEs) are a group of neurodegenerative disorders affecting both humans and animals. There is no available treatment or therapy for these fatal diseases. The infectious agent associated with TSEs (termed prion) appears to be composed uniquely of a protein, which is a conformationally-modified version (PrPSc) of the cellular prion protein (PrPC). The disease is propagated by the conversion of host PrPC into PrPSc induced by small quantities of PrPSc. Interestingly, prions occur in the form of different strains that show distinct biological and physicochemical properties. TSEs can have diverse origins, including genetic, sporadic (putatively spontaneous) and infectious. The occurrence of sporadic cases of prion diseases in humans and maybe in other species, i.e. atypical bovine spongiform encephalopathy (BSE) in European and USA cattle and atypical scrapie cases in sheep suggest that spontaneous prion diseases may happen infrequently but ubiquitously. However, there are no reported cases of spontaneously-occurring prion disease in experimental wild-type rodent models. We have used a novel technique, Protein Misfolding Cyclic Amplification (PMCA) to rapidly propagate prions in the test tube, using normal brain homogenate as substrate. Prions propagated in vitro are infectious in vivo and maintain their prion strain specificity. PMCA has been used to efficiently amplify a variety of prion strains from mouse, hamster, bank vole, deer, cattle, sheep and human. Therefore, to mimic spontaneous generation of infectivity in vitro becomes one of the most important challenges in the prion field. We show here, for the first time, the de novo generation of infectious prions from bank voles (Clethrionomys glareolus) starting with non-infectious brain homogenates. Several biochemically different prion strains were generated using two different wild-type vole genotypes. The de novo in vitro generated PrPSc was highly infectious after its inoculation in bank voles. We show an extensive characterization of this "spontaneous" phenomenon.
http://www.healthtech.com/Conferences_Overview.aspx?c=518&id=59662&c=518
Pathogenesis Chairperson: Suzette Priola, Ph.D.
11:10 Accumulation of Prion Protein in the Brain That is Not Associated with Transmissible Disease Pedro Piccardo, M.D., Senior Investigator, OBRR / DETTD / LBPUA, FDA (Invited)
11:35 High Levels of TSE Infectivity Can Be Associated with Little or No Detectable PrPSc in Vivo Rona Barron, Ph.D., Neuropathogenesis Unit, Roslin Institute and Royal (Dick) School of Veterinary Studies This work examines the relationship between TSE infectivity and the abnormal prion protein, PrPSc. In a mouse model of disease we have shown high titres of TSE infectivity in brain tissue which contains little or no PrP-res. We also found no evidence of other abnormal PrP isofoms such as PK-sen PrPSc. These data question the true relationship between PrPSc and TSE infectivity, and the current reliance on PrPSc as the sole diagnostic marker for TSE disease.
12:00 Conversion of the BASE Prion into the BSE Prion: The Origin of BSE? Fabrizio Tagliavini, Ph.D., Director, Division of Neurology 5 & Neuropathology, Neurological Institute "Carlo Besta" Twenty years after the identification of bovine spongiform encephalopathy (BSE), the origin of the causal agent is still unknown. This issue is of fundamental importance, since knowledge of the origin of the BSE agent is essential for prevention of future outbreak of the disease or variants thereof in cattle and other mammals. We carried out transmission studies with transgenic mice expressing bovine PrP and four lines of non-transgenic mice and found that an atypical form of spongiform encephalopathy of cattle, termed BASE or BSE-L, is caused by a prion strain distinct from that of classical BSE. Noteworthy, this newly characterized prion strain has the ability to convert into the classical BSE strain upon serial transmission to inbred mouse lines. According to these results, BASE--which is regarded as a sporadic form of prion disease in cattle--may be the origin of BSE, following conversion of the causal agent in an intermediate host.
12:45 Luncheon Technology Workshop (Sponsorship Available) or Lunch on Your Own
2:00 Sporadic CJD and Atypical BSE: Two Children of One Protein Maurizio Pocchiari, Ph.D., Director of Research, Virology, Istituto Superiore Di Sanita The identification of forms of TSE diseases in cattle caused by prion strains different from BSE has raised new concerns on the possibility that these novel agents might induce disease in humans with a phenotype resembling sporadic CJD. The analysis of the distribution of the different molecular subtypes of sporadic CJD might give some answers.
http://www.healthtech.com/Conferences_Overview.aspx?c=518&id=59662&c=518
let's see, a few examples of our extensive BSE surveillance plan ;
On December 23, 2003, the U.S. Department of Agriculture (USDA) announced a presumptive diagnosis of the first known case of BSE in the United States. It was in an adult Holstein cow from Washington State. This diagnosis was confirmed by an international reference laboratory in Weybridge, England, on December 25. Trace-back based on an ear-tag identification number and subsequent genetic testing confirmed that the BSE-infected cow was imported into the United States from Canada in August 2001. Because the animal was non-ambulatory (a “downer cow”) at slaughter, brain tissue samples were taken by USDA’s Animal and Plant Health Inspection Service as part of its targeted surveillance for BSE. However the animal’s condition was attributed to complications from calving. After the animal was examined by a USDA Food Safety and Inspection Service (FSIS) veterinary medical officer both before and after slaughter, the carcass was released for use as food for human consumption. During slaughter, the tissues considered to be at high risk for the transmission of the BSE agent were removed. On December 24, 2003, FSIS recalled beef from cattle slaughtered in the same plant on the same day as the BSE positive cow. (see Bovine Spongiform Encephalopathy in a Dairy Cow - Washington State, 2003.)
On June 24, 2005, the USDA announced receipt of final results from The Veterinary Laboratories Agency in Weybridge, England, confirming BSE in a cow that had conflicting test results in 2004. This cow was from Texas, died at approximately 12 years of age, and represented the first endemic case of BSE in the United States. (see Texas BSE Investigation, Final Epidemiology Report, August 2005 (PDF – 83 KB))
On March 15, 2006, the USDA announced the confirmation of BSE in a cow in Alabama. The newly confirmed case was identified in a non-ambulatory (downer) cow on a farm in Alabama. The animal was euthanized by a local veterinarian and buried on the farm. The age of the cow was estimated by examination of the dentition as 10-years-old. It had no ear tags or distinctive marks; the herd of origin could not be identified despite an intense investigation (see second featured item above and Alabama BSE Investigation, Final Epidemiology Report, May 2006).
snip...
Strains of BSE There is increasing evidence that there are different strains of BSE: the typical BSE strain responsible for the outbreak in the United Kingdom and two atypical strains (H and L strains).
Typical BSE strain -- The BSE strain responsible for most of the BSE cases in Canada is the same classic or typical strain linked to the outbreak in the United Kingdom. It is known to be preventable through elimination of BSE contaminated feed and has been causally linked to vCJD in humans. This typical strain has not yet been identified in any U.S.-born cattle.
Atypical BSE strain -- In July 2007, the UK Spongiform Encephalopathy Advisory Committee (SEAC) suggested that atypical BSE may be a distinct strain of prion disease. Unlike typical BSE, cases of atypical BSE, according to SEAC, may have risen spontaneously (although transmission through feed or the environment cannot be ruled out). Recently reported French surveillance data support this theory that unlike typical BSE, atypical BSE appears to represent sporadic disease
Both of the U.S.-born BSE cases and two of the 15 Canadian-born BSE cases were 10 years of age or older and three of these older North American cases for whom the strain type is presently known were linked to an atypical BSE strain known as the H-strain. Publication of the strain testing results on the 13 year-old BSE-infected Canadian cow identified in December 2007 is pending.
http://cdc.gov/ncidod/dvrd/bse/
Saturday, January 24, 2009
Bovine Spongiform Encephalopathy h-BSE ATYPICAL USA 2008 Annual Report
Research Project: Study of Atypical Bse
Location: Virus and Prion Diseases of Livestock
2008 Annual Report
snip...
Thursday, December 04, 2008 2:37 PM
"we have found that H-BSE can infect humans."
personal communication with Professor Kong. ...TSS
snip...
http://bse-atypical.blogspot.com/2009/01/bovine-spongiform-encephalopathy-h-bse.html
Sunday, December 28, 2008
MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy
Greetings,
I thought a quick review of the Bush's terribly flawed and failed mad cow disease policy, from the illegal feeding of literally millions and millions of pounds of highly suspect, and banned mad feed, to the failed BSE surveillance program, all of which exposed, needlessly, millions of people to the mad cow agent i.e. Transmissible Spongiform Encephalopathy. ...
Parentage-based DNA traceback in beef and dairy cattle 2008
http://www.ars.usda.gov/sp2UserFiles/Place/54380570/HeatonPublications/HeatonParentage-Traceback2008o.pdf
48 hour traceback for BSE mad cow disease in the USA ???
NOT in your lifetime !
8 YEARS IN REVIEW OF THE MAD COW DEBACLE IN THE USA ;
FOR IMMEDIATE RELEASE Statement May 4, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
snip...full text ;
http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html
Friday, August 29, 2008
CREEKSTONE VS USDA COURT OF APPEALS, BUSH SAYS, NO WAY, NO HOW
http://madcowtesting.blogspot.com/2008/08/creekstone-vs-usda-court-of-appeals.html
Sunday, March 16, 2008
MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE
http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html
HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory JUNE 2008
snip...
Tissue infectivity and strain typing of the many variants Manuscript of the human and animal TSEs are paramount in all variants of all TSE. There must be a proper classification that will differentiate between all these human TSE in order to do this. With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously. ...
snip...
http://cjdmadcowbaseoct2007.blogspot.com/2008/06/human-and-animal-tse-classifications-ie.html
November 25, 2008
Update On Feed Enforcement Activities To Limit The Spread Of BSE
http://madcowfeed.blogspot.com/2008/11/november-2008-update-on-feed.html
"the biochemical signature of PrPres in the BASE-inoculated animal was found to have a higher proteinase K sensitivity of the octa-repeat region. We found the same biochemical signature in three of four human patients with sporadic CJD and an MM type 2 PrP genotype who lived in the same country as the infected bovine." ... interesting. ... TSS
Thursday, June 05, 2008
Review on the epidemiology and dynamics of BSE epidemics
Vet. Res. (2008) 39:15 www.vetres.org DOI: 10.1051/vetres:2007053 c INRA, EDP Sciences, 2008 Review article
snip...
And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward [10], as well as between L-type BSE and CJD [17]. These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.
snip...
Cases of atypical BSE have only been found in countries having implemented large active surveillance programs. As of 1st September 2007, 36 cases (16 H, 20 L) have been described all over the world in cattle: Belgium (1 L) [23], Canada (1 H)15, Denmark (1 L)16, France (8 H, 6 L)17, Germany (1 H, 1 L) [13], Italy (3 L)18, Japan (1 L) [71], Netherlands (1 H, 2 L)19, Poland (1 H, 6 L)20, Sweden (1 H)21, United Kingdom (1 H)22, and USA (2 H)23. Another H-type case has been found in a 19 year old miniature zebu in a zoological park in Switzerland [56]. It is noteworthy that atypical cases have been found in countries that did not experience classical BSE so far, like Sweden, or in which only few cases of classical BSE have been found, like Canada or the USA.
And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward [10], as well as between L-type BSE and CJD [17]. These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.
full text 18 pages ;
http://www.vetres.org/index.php?option=article&access=standard&Itemid=129&url=/articles/vetres/pdf/2008/04/v07232.pdf
please see full text ;
http://bse-atypical.blogspot.com/2008/06/review-on-epidemiology-and-dynamics-of.html
***Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.***
Progress Report from the National Prion Disease Pathology Surveillance Center
An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD
April 3, 2008
http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45
In this context, a word is in order about the US testing program. After the discovery of the first (imported) cow in 2003, the magnitude of testing was much increased, reaching a level of >400,000 tests in 2005 (Figure 4). Neither of the 2 more recently indigenously infected older animals with nonspecific clinical features would have been detected without such testing, and neither would have been identified as atypical without confirmatory Western blots. Despite these facts, surveillance has now been decimated to 40,000 annual tests (USDA news release no. 0255.06, July 20, 2006) and invites the accusation that the United States will never know the true status of its involvement with BSE.
In short, a great deal of further work will need to be done before the phenotypic features and prevalence of atypical BSE are understood. More than a single strain may have been present from the beginning of the epidemic, but this possibility has been overlooked by virtue of the absence of widespread Western blot confirmatory testing of positive screening test results; or these new phenotypes may be found, at least in part, to result from infections at an older age by a typical BSE agent, rather than neonatal infections with new "strains" of BSE. Neither alternative has yet been investigated.
http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm
Wednesday, August 20, 2008
Bovine Spongiform Encephalopathy Mad Cow Disease typical and atypical strains, was there a cover-up ?
http://bse-atypical.blogspot.com/2008/08/bovine-spongiform-encephalopathy-mad.html
A New Prionopathy OR more of the same old BSe and sporadic CJD
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html
Communicated by: Terry S. Singeltary Sr.
[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP]
http://pro-med.blogspot.com/2007/11/proahedr-prion-disease-update-2007-07.html
http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1010,39963
There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.
He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf
sporadic Fatal Familial Insomnia
http://sporadicffi.blogspot.com/
JOURNAL OF NEUROLOGY
MARCH 26, 2003
RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States
Email Terry S. Singeltary:
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000071/!x-usc:mailto:flounder9@verizon.net
I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?
http://www.neurology.org/cgi/eletters/60/2/176#535
THE PATHOLOGICAL PROTEIN
Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9
June 2003
BY Philip Yam
CHAPTER 14 LAYING ODDS
Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.
http://www.thepathologicalprotein.com/
Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA
Diagnosis and Reporting of Creutzfeldt-Jakob Disease
To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.
Terry S. Singeltary, Sr Bacliff, Tex
1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. FREE FULL TEXT
http://jama.ama-assn.org/cgi/content/extract/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
2 January 2000
British Medical Journal U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well
http://www.bmj.com/cgi/eletters/320/7226/8/b#6117
15 November 1999
British Medical Journal vCJD in the USA * BSE in U.S.
http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406
Creutzfeldt Jakob Disease
http://creutzfeldt-jakob-disease.blogspot.com/
USA PRION UNIT BLOG
http://prionunitusaupdate2008.blogspot.com/
Sunday, April 20, 2008
Progress Report from the National Prion Disease Pathology Surveillance Center April 3, 2008
Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.
see full text ;
http://prionunitusaupdate2008.blogspot.com/2008/04/progress-report-from-national-prion.html
CJD TEXAS (cjd clusters)
http://cjdtexas.blogspot.com/
USA WRITTEN CJD QUESTIONNAIRE ???
http://cjdquestionnaire.blogspot.com/
Attending Dr.: Date / Time Admitted : 12/14/97 1228
UTMB University of Texas Medical Branch Galveston, Texas 77555-0543 (409) 772-1238 Fax (409) 772-5683 Pathology Report
FINAL AUTOPSY DIAGNOSIS Autopsy' Office (409)772-2858
FINAL AUTOPSY DIAGNOSIS
I. Brain: Creutzfeldt-Jakob disease, Heidenhain variant.
http://creutzfeldt-jakob-disease.blogspot.com/2008/07/heidenhain-variant-creutzfeldt-jakob.html
2007
The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.
http://www.cjdfoundation.org/fact.html
TSS
Monday, January 26, 2009
Monday, January 12, 2009
FDA Scientists Complain About Corruption Inside The Agency
FDA scientists complain to Obama of 'corruption'
By RICARDO ALONSO-ZALDIVAR
updated 5:10 p.m. CT, Thurs., Jan. 8, 2009 WASHINGTON - In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday, on the letterhead of the agency's Center for Devices and Radiological Health.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
The FDA declined to publicly respond to the letter, but said it is working to address the concerns.
In their letter, the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.
FDA spokeswoman Judy Leon said in response: "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."
Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes within the agency.
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
http://www.msnbc.msn.com/id/28565720/
FDA Scientists Complain About Corruption Inside The Agency
By Anna Boyd 13:39, January 11th 2009
A group of nine scientists at the Food and Drug Administration sent a letter to President-elect Barack Obama and his transition team, asking for immediate intervention as the agency is “fundamentally broken” and fails to fulfill its mission.
“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” read the six-page letter, written on the agency’s Center for Devices and radiological letterhead.
The scientists went even further and said there is an atmosphere at FDA in which the honest employee fears the dishonest one, when it should be the other way around. Moreover, the FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."
Responding to the accusations, agency spokeswoman Judy Leon said the FDA has been working “very closely” with Mr. Obama’s transition team and will address any issues or concerns the team presents. She added the agency is “actively engaged in a process to explore the staff members' concerns and take appropriate action.”
Members of the transition team weren't available to discuss over the issues in the letter or whether they intend to address it publicly.
http://www.efluxmedia.com/news_FDA_Scientists_Complain_About_Corruption_Inside_The_Agency_33082.html
FDA Scientists Ask For Obama’s Help To Fight Corruption Inside The Agency
By Irene Collins 18:43, January 10th 2009
It appears that some scientists at the FDA wrote to President-Elect Barack Obama’s transition team, basically begging for help and outlining a number of problems with an agency they describe as “fundamentally broken.” Nine scientists who claim the FDA is a “fundamentally broken” agency authored the letter, sent Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.
The letter, addressed to John Podesta, says the atmosphere at the agency is one where “the honest employee fears the dishonest employee.”
Podesta is head of the Obama transition team but others receiving copies include Tom Daschle, Obama’s pick to lead the Department of Health and Human Services; Joshua Sharfstein, the physician leading the transition team’s assessment of FDA activities; and Senator Edward Kennedy, chairman of the health committee.
The scientists wrote that they have raised their concerns with FDA Commissioner Andrew von Eschenbach and Bill McConagha, an attorney and the assistant commissioner for accountability and integrity at the agency, but added that the agency has taken no action to address the issues.
In addition, they wrote that FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."
The Obama transition team has not issued a statement about the scientists’ complaint of corruption among FDA managers.
http://www.efluxmedia.com/news_FDA_Scientists_Ask_For_Obamas_Help_To_Fight_Corruption_Inside_The_Agency_33067.html
For whatever it's worth, myself and others have been asking for an investigation into the FDA and the USDA et al for a decade or more. ...TSS
Friday, June 13, 2008
Federal Oversight of Food Safety: FDA Has Provided Few Details GAO-08-909T June 12, 2008
http://fdafailedus.blogspot.com/2008/06/federal-oversight-of-food-safety-fda.html
Thu Dec 6, 2007 11:38
FDA IN CRISIS MODE, AMERICAN LIVES AT RISK
http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html
FDA SCIENCE AND MISSION AT RISK
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf
http://fdafailedus.blogspot.com/
UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL WASHINGTON D.C. 20250
DEC 28, 2007
Mr. Terry S. Singeltary, Sr. P.O. Box 42 Bacliff, Texas 77518
Subject: FOIA Appeal-Log No. 08-00034 (No. 07-00060)
Dear Mr. Singeltary:
This is in response to your December 3, 2007, Freedom of Information Act (FOIA), 5 U.S.C. & 552, appeal of the November 20, 2007, decision of Ms. Deirdre MacNeil, FOIA/Privacy Act (PA) Attorney, Office of Inspector General (OIG), Department of Agriculture (USDA). As explained below, your FOIA appeal is denied.
As background, on March 1, 2007, you requested the "final results of the TSE Mouse-bioassays of those Atypical TSE in the Vermont Sheep." FOIA requires the release of agency records except where one or more of the nine enumerated exceptions apply. On November 20, 2007, Ms. MacNeil responded to your request by sending you seven pages from Hotline files PS-3340-0024, which was responsive to your request. Ms. MacNeil withheld identifying information pursuant to Exceptions 6 and 7(C) of the FOIA. See 5. U.S.C.& 552(b)(6) and (7)(C). On December 3, 2007, you appealed Ms. MacNeils decision.
12-3-07
To The Honorable Inspector General USDA,
snip...
see full history of this saga here ;
http://foiamadsheepmadrivervalley.blogspot.com/
Tuesday, April 29, 2008 Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency ----- Original Message -----
From: "Terry S. Singeltary Sr." flounder9@verizon.net To: "Bovine Spongiform Encephalopathy" BSE-L@aegee.org Cc: heggem.daniel@epa.gov; sibert.christopher@epa.gov; denne.jane@epa.gov; hazen.susan@epa.gov; mcrosby@ucsusa.org; erobinson@ucsusa.org; enegin@ucsusa.org; cjdvoice@yahoogroups.com; madcow@lists.iatp.org
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) has the simple yet profound charge "to protect human health and the environment." EPA scientists apply their expertise to protect the public from air and water pollution, clean up hazardous waste, and study emerging threats such as global warming. Because each year brings new and potentially toxic chemicals into our homes and workplaces, because air pollution still threatens our public health, and because environmental challenges are becoming more complex and global, a strong and capable EPA is more important than ever.
Yet challenges from industry lobbyists and some political leaders to the agency's decisions have too often led to the suppression and distortion of the scientific findings underlying those decisions—to the detriment of both science and the health of our nation. While every regulatory agency must balance scientific findings with other considerations, policy makers need access to the highest-quality scientific information to make fully informed decisions.
Concern over this problem led the Union of Concerned Scientists (UCS) to investigate political interference in science at the EPA. The investigation combines dozens of interviews with current and former EPA staff, analysis of government documents, more than 1,600 responses to a survey sent to current EPA scientists, and written comments from EPA scientists.
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations. ...
snip...please see full text ;
Interference at the EPA Science
http://sciencebushwhacked.blogspot.com/
Sunday, December 28, 2008
MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy
Greetings,
I thought a quick review of the Bush's terribly flawed and failed mad cow disease policy, from the illegal feeding of literally millions and millions of pounds of highly suspect, and banned mad feed, to the failed BSE surveillance program, all of which exposed, needlessly, millions of people to the mad cow agent i.e. Transmissible Spongiform Encephalopathy. ...
Parentage-based DNA traceback in beef and dairy cattle 2008
http://www.ars.usda.gov/sp2UserFiles/Place/54380570/HeatonPublications/HeatonParentage-Traceback2008o.pdf
48 hour traceback for BSE mad cow disease in the USA ???
NOT in your lifetime !
8 YEARS IN REVIEW OF THE MAD COW DEBACLE IN THE USA ;
FOR IMMEDIATE RELEASE Statement May 4, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
snip...full text ;
http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html
USDA CERTIFIED DEADSTOCK DOWNER COW SCHOOL LUNCH PROGRAM
http://downercattle.blogspot.com/
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
By RICARDO ALONSO-ZALDIVAR
updated 5:10 p.m. CT, Thurs., Jan. 8, 2009 WASHINGTON - In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday, on the letterhead of the agency's Center for Devices and Radiological Health.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
The FDA declined to publicly respond to the letter, but said it is working to address the concerns.
In their letter, the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.
FDA spokeswoman Judy Leon said in response: "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."
Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes within the agency.
Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
http://www.msnbc.msn.com/id/28565720/
FDA Scientists Complain About Corruption Inside The Agency
By Anna Boyd 13:39, January 11th 2009
A group of nine scientists at the Food and Drug Administration sent a letter to President-elect Barack Obama and his transition team, asking for immediate intervention as the agency is “fundamentally broken” and fails to fulfill its mission.
“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” read the six-page letter, written on the agency’s Center for Devices and radiological letterhead.
The scientists went even further and said there is an atmosphere at FDA in which the honest employee fears the dishonest one, when it should be the other way around. Moreover, the FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."
Responding to the accusations, agency spokeswoman Judy Leon said the FDA has been working “very closely” with Mr. Obama’s transition team and will address any issues or concerns the team presents. She added the agency is “actively engaged in a process to explore the staff members' concerns and take appropriate action.”
Members of the transition team weren't available to discuss over the issues in the letter or whether they intend to address it publicly.
http://www.efluxmedia.com/news_FDA_Scientists_Complain_About_Corruption_Inside_The_Agency_33082.html
FDA Scientists Ask For Obama’s Help To Fight Corruption Inside The Agency
By Irene Collins 18:43, January 10th 2009
It appears that some scientists at the FDA wrote to President-Elect Barack Obama’s transition team, basically begging for help and outlining a number of problems with an agency they describe as “fundamentally broken.” Nine scientists who claim the FDA is a “fundamentally broken” agency authored the letter, sent Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.
The letter, addressed to John Podesta, says the atmosphere at the agency is one where “the honest employee fears the dishonest employee.”
Podesta is head of the Obama transition team but others receiving copies include Tom Daschle, Obama’s pick to lead the Department of Health and Human Services; Joshua Sharfstein, the physician leading the transition team’s assessment of FDA activities; and Senator Edward Kennedy, chairman of the health committee.
The scientists wrote that they have raised their concerns with FDA Commissioner Andrew von Eschenbach and Bill McConagha, an attorney and the assistant commissioner for accountability and integrity at the agency, but added that the agency has taken no action to address the issues.
In addition, they wrote that FDA has promoted and rewarded some of the managers involved with the inappropriate practices. They also complained about devices that have not been properly labeled, about managers without appropriate experience who have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns, or of FDA experts who have been excluded from product meetings because manufacturers felt that they were "biased."
The Obama transition team has not issued a statement about the scientists’ complaint of corruption among FDA managers.
http://www.efluxmedia.com/news_FDA_Scientists_Ask_For_Obamas_Help_To_Fight_Corruption_Inside_The_Agency_33067.html
For whatever it's worth, myself and others have been asking for an investigation into the FDA and the USDA et al for a decade or more. ...TSS
Friday, June 13, 2008
Federal Oversight of Food Safety: FDA Has Provided Few Details GAO-08-909T June 12, 2008
http://fdafailedus.blogspot.com/2008/06/federal-oversight-of-food-safety-fda.html
Thu Dec 6, 2007 11:38
FDA IN CRISIS MODE, AMERICAN LIVES AT RISK
http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html
FDA SCIENCE AND MISSION AT RISK
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf
http://fdafailedus.blogspot.com/
UNITED STATES DEPARTMENT OF AGRICULTURE OFFICE OF INSPECTOR GENERAL WASHINGTON D.C. 20250
DEC 28, 2007
Mr. Terry S. Singeltary, Sr. P.O. Box 42 Bacliff, Texas 77518
Subject: FOIA Appeal-Log No. 08-00034 (No. 07-00060)
Dear Mr. Singeltary:
This is in response to your December 3, 2007, Freedom of Information Act (FOIA), 5 U.S.C. & 552, appeal of the November 20, 2007, decision of Ms. Deirdre MacNeil, FOIA/Privacy Act (PA) Attorney, Office of Inspector General (OIG), Department of Agriculture (USDA). As explained below, your FOIA appeal is denied.
As background, on March 1, 2007, you requested the "final results of the TSE Mouse-bioassays of those Atypical TSE in the Vermont Sheep." FOIA requires the release of agency records except where one or more of the nine enumerated exceptions apply. On November 20, 2007, Ms. MacNeil responded to your request by sending you seven pages from Hotline files PS-3340-0024, which was responsive to your request. Ms. MacNeil withheld identifying information pursuant to Exceptions 6 and 7(C) of the FOIA. See 5. U.S.C.& 552(b)(6) and (7)(C). On December 3, 2007, you appealed Ms. MacNeils decision.
12-3-07
To The Honorable Inspector General USDA,
snip...
see full history of this saga here ;
http://foiamadsheepmadrivervalley.blogspot.com/
Tuesday, April 29, 2008 Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency ----- Original Message -----
From: "Terry S. Singeltary Sr." flounder9@verizon.net To: "Bovine Spongiform Encephalopathy" BSE-L@aegee.org Cc: heggem.daniel@epa.gov; sibert.christopher@epa.gov; denne.jane@epa.gov; hazen.susan@epa.gov; mcrosby@ucsusa.org; erobinson@ucsusa.org; enegin@ucsusa.org; cjdvoice@yahoogroups.com; madcow@lists.iatp.org
Sent: Monday, April 28, 2008 9:48 PM
Subject: Interference at the EPA Science and Politics at the U.S. Environmental Protection Agency
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) has the simple yet profound charge "to protect human health and the environment." EPA scientists apply their expertise to protect the public from air and water pollution, clean up hazardous waste, and study emerging threats such as global warming. Because each year brings new and potentially toxic chemicals into our homes and workplaces, because air pollution still threatens our public health, and because environmental challenges are becoming more complex and global, a strong and capable EPA is more important than ever.
Yet challenges from industry lobbyists and some political leaders to the agency's decisions have too often led to the suppression and distortion of the scientific findings underlying those decisions—to the detriment of both science and the health of our nation. While every regulatory agency must balance scientific findings with other considerations, policy makers need access to the highest-quality scientific information to make fully informed decisions.
Concern over this problem led the Union of Concerned Scientists (UCS) to investigate political interference in science at the EPA. The investigation combines dozens of interviews with current and former EPA staff, analysis of government documents, more than 1,600 responses to a survey sent to current EPA scientists, and written comments from EPA scientists.
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations. ...
snip...please see full text ;
Interference at the EPA Science
http://sciencebushwhacked.blogspot.com/
Sunday, December 28, 2008
MAD COW DISEASE USA DECEMBER 28, 2008 an 8 year review of a failed and flawed policy
Greetings,
I thought a quick review of the Bush's terribly flawed and failed mad cow disease policy, from the illegal feeding of literally millions and millions of pounds of highly suspect, and banned mad feed, to the failed BSE surveillance program, all of which exposed, needlessly, millions of people to the mad cow agent i.e. Transmissible Spongiform Encephalopathy. ...
Parentage-based DNA traceback in beef and dairy cattle 2008
http://www.ars.usda.gov/sp2UserFiles/Place/54380570/HeatonPublications/HeatonParentage-Traceback2008o.pdf
48 hour traceback for BSE mad cow disease in the USA ???
NOT in your lifetime !
8 YEARS IN REVIEW OF THE MAD COW DEBACLE IN THE USA ;
FOR IMMEDIATE RELEASE Statement May 4, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
snip...full text ;
http://bse-atypical.blogspot.com/2008/12/mad-cow-disease-usa-december-28-2008-8.html
USDA CERTIFIED DEADSTOCK DOWNER COW SCHOOL LUNCH PROGRAM
http://downercattle.blogspot.com/
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Sunday, December 21, 2008
EPA scientists blast FDA advice on fish
EPA scientists blast FDA advice on fish
Experts insist mercury warnings for women, kids 'inadequate'
By MICHAEL HAWTHORNE Chicago Tribune Dec. 20, 2008, 5:32PM
In the waning days of the Bush presidency, the Food and Drug Administration is pushing to scuttle the government's advice about mercury-contaminated seafood, a dramatic policy change that would, in effect, encourage women and children to eat more fish despite growing concerns about the toxic metal.
The FDA's recommendations, sent recently to the White House Office of Management and Budget for approval, prompted a sharp rebuke from scientists at the Environmental Protection Agency who, in memos circulated earlier this month, described them as "scientifically flawed and inadequate."
A joint advisory issued by the two agencies in 2004 cautions women of childbearing age, nursing mothers and young children to limit seafood consumption to 12 ounces a week. But in a draft version of the FDA's new report, the agency says its own modeling shows that kids can benefit from eating fish.
The FDA argues that nutrients in fish offset the risks posed by mercury and could boost a child's IQ by three points. Its conclusion is similar to claims by the seafood industry.
EPA scientists, though, say the FDA's report reaches conclusions that aren't supported by the studies it cites, and at various points either trivializes or overstates existing research.
Moreover, the EPA scientists say, the FDA fails to consider that some species of fish tend to have much higher mercury levels than others. The EPA's comments reflect long-standing criticism that the government isn't giving Americans enough advice about which types of seafood are safest to eat.
Before Bush leaves office The FDA's proposal is among a series of controversial policy changes moving quickly as the Bush administration prepares to leave office. Seafood industry lobbyists want to scale back the government's mercury warning, which they contend is depressing sales and scaring women away from eating fish.
In contrast, President-elect Barack Obama and leaders of the Democratic-controlled Congress have pledged to enforce tougher mercury policies.
"Once again, the Bush administration seems intent on ignoring sound science on mercury poisoning," Sen. Patrick Leahy, D-Vt., said. "This backroom bouquet for special interests should be stopped in its tracks."
The Environmental Working Group, an advocacy organization that obtained the FDA report, sent a letter to EPA Administrator Stephen Johnson urging him to fight the proposal.
In an e-mail response to questions, the FDA said a final decision had not been reached. "The FDA will make no final determination until all the relevant comments and scientific analysis has been carefully considered," the agency wrote.
Choosing low-mercury fish Studies have shown that exposure to mercury in the womb, mostly from fish eaten by mothers, can irreversibly damage the brain before birth, causing subtle delays in walking and talking as well as decreased attention span and memory. Some research suggests that mercury also could increase the risk of heart disease in adults.
A recent study found that the percentage of women with high mercury levels declined from 2000 to 2004, even though those women were eating the same amount of seafood. The study's authors said their finding suggests that consumer advisories are prompting women to eat fish low in mercury.
Sniping between the FDA and EPA is nothing new. The two agencies have fought for years about how to caution women and children about mercury.
http://www.chron.com/disp/story.mpl/nation/6174650.html
TSS
Experts insist mercury warnings for women, kids 'inadequate'
By MICHAEL HAWTHORNE Chicago Tribune Dec. 20, 2008, 5:32PM
In the waning days of the Bush presidency, the Food and Drug Administration is pushing to scuttle the government's advice about mercury-contaminated seafood, a dramatic policy change that would, in effect, encourage women and children to eat more fish despite growing concerns about the toxic metal.
The FDA's recommendations, sent recently to the White House Office of Management and Budget for approval, prompted a sharp rebuke from scientists at the Environmental Protection Agency who, in memos circulated earlier this month, described them as "scientifically flawed and inadequate."
A joint advisory issued by the two agencies in 2004 cautions women of childbearing age, nursing mothers and young children to limit seafood consumption to 12 ounces a week. But in a draft version of the FDA's new report, the agency says its own modeling shows that kids can benefit from eating fish.
The FDA argues that nutrients in fish offset the risks posed by mercury and could boost a child's IQ by three points. Its conclusion is similar to claims by the seafood industry.
EPA scientists, though, say the FDA's report reaches conclusions that aren't supported by the studies it cites, and at various points either trivializes or overstates existing research.
Moreover, the EPA scientists say, the FDA fails to consider that some species of fish tend to have much higher mercury levels than others. The EPA's comments reflect long-standing criticism that the government isn't giving Americans enough advice about which types of seafood are safest to eat.
Before Bush leaves office The FDA's proposal is among a series of controversial policy changes moving quickly as the Bush administration prepares to leave office. Seafood industry lobbyists want to scale back the government's mercury warning, which they contend is depressing sales and scaring women away from eating fish.
In contrast, President-elect Barack Obama and leaders of the Democratic-controlled Congress have pledged to enforce tougher mercury policies.
"Once again, the Bush administration seems intent on ignoring sound science on mercury poisoning," Sen. Patrick Leahy, D-Vt., said. "This backroom bouquet for special interests should be stopped in its tracks."
The Environmental Working Group, an advocacy organization that obtained the FDA report, sent a letter to EPA Administrator Stephen Johnson urging him to fight the proposal.
In an e-mail response to questions, the FDA said a final decision had not been reached. "The FDA will make no final determination until all the relevant comments and scientific analysis has been carefully considered," the agency wrote.
Choosing low-mercury fish Studies have shown that exposure to mercury in the womb, mostly from fish eaten by mothers, can irreversibly damage the brain before birth, causing subtle delays in walking and talking as well as decreased attention span and memory. Some research suggests that mercury also could increase the risk of heart disease in adults.
A recent study found that the percentage of women with high mercury levels declined from 2000 to 2004, even though those women were eating the same amount of seafood. The study's authors said their finding suggests that consumer advisories are prompting women to eat fish low in mercury.
Sniping between the FDA and EPA is nothing new. The two agencies have fought for years about how to caution women and children about mercury.
http://www.chron.com/disp/story.mpl/nation/6174650.html
TSS
Wednesday, August 6, 2008
Company advances on plan for West Texas nuclear dump
.jpg)
(railcars loaded with MOUND COLD WAR NUCLEAR AFTER-BIRTH headed to Texas)
By JANET ELLIOTT Copyright 2008 Houston Chronicle Austin Bureau Aug. 5, 2008, 11:23PM
AUSTIN — Waste Control Specialists is moving ahead with construction of a radioactive waste dump in Andrews County in West Texas, despite a pending lawsuit challenging the project.
The Dallas company said Tuesday it has awarded a three-year $80 million contract to URS, a San Francisco-based engineering and construction firm.
The contract includes the addition of a railroad loop and facilities for unloading hazardous waste from rail cars, as well as construction of two adjacent landfills for different categories of radioactive waste.
1 of 2 applications OK'd State environmental regulators in May granted Waste Control a license to dispose of byproduct material, including waste from nuclear weapons processing and uranium mining.
The company has a second application pending for "low-level" waste, which would allow the disposal of a higher level of radioactive material, including waste from nuclear power plants.
Waste Control President Rodney Baltzer said construction would begin immediately on the rail facilities and byproducts landfill.
No work will be done on the low-level site until the company receives a license.
Baltzer said in a news release that URS has been involved in the licensing process and is familiar with the site.
"URS used that knowledge in a competitive bidding process to provide the best value for WCS," he said.
Waste Control is owned by Harold Simmons, a major donor to Gov. Rick Perry and other state politicians.
Risk to water questioned The Sierra Club filed a lawsuit last month in Travis County to overturn the byproducts disposal license.
The environmental group went to court after the Texas Commission on Environmental Quality denied its request for a contested hearing on the project.
"It's a concern that they're moving forward," said Cyrus Reed, a lobbyist for the Sierra Club.
"We think the underlying geology has not been adequately studied and, therefore, confirmed as being safe for the disposal of this type of waste."
The site is controversial because of its location near underground water.
A team of geologists and engineers who reviewed the location for the Texas Commission on Environmental Quality concluded last year that the low-level waste disposal license should be denied.
They said one water table may be closer than 14 feet, making it "highly likely" that water could seep into the dump as annual rainfall increases because of climate change.
Both landfills would be on 1,300 acres WCS owns near the Texas-New Mexico border. Baltzer said the site has been extensively tested to ensure the material can be contained safely.
"The landfills will have similar designs, with disposal in the site's almost impenetrable red bed claystones," he said.
Among the materials to be buried are 3,776 steel containers of waste from an Ohio facility that processed uranium for Cold War-era nuclear weapons.
janet.elliott@chron.com
Wednesday, July 30, 2008
TEXAS WINS TO BE NEXT BIG DUMPING GROUND FOR NUCLEAR WEAPONS RADIOACTIVE WASTE
(see more photo's of railcars loaded with MOUND COLD WAR NUCLEAR AFTER-BIRTH headed to Texas)
Terry S. Singeltary Sr., Bacliff, Texas USA 77518
Wednesday, July 30, 2008
TEXAS WINS TO BE NEXT BIG DUMPING GROUND FOR NUCLEAR WEAPONS RADIOACTIVE WASTE
-----Original Message-----
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: Thursday, May 22, 2008 5:01 PM To: janet.elliott@chron.com Cc: viewpoints@chron.com; tbeyerlein@DaytonDailyNews.com
Subject: re-Company wins license to bury nuclear waste
re-Company wins license to bury nuclear waste Houston Chronicle May 22, 2008
AUSTIN — State environmental regulators voted 2-1 Wednesday to grant a Dallas company a license to dispose of waste from nuclear weapons processing and uranium mining in Andrews County in West Texas.
Texas Commission on Environmental Quality Chairman Buddy Garcia and Commissioner Bryan Shaw voted to issue the "by-products" license to Waste Control Specialists. The company is owned by Harold Simmons, a top donor to Gov. Rick Perry, who appoints members to the TCEQ.
http://www.chron.com/disp/story.mpl/metropolitan/5795238.html
http://www.chron.com/disp/commnts.mpl/metropolitan/5795238.html?plckCurrentPage=2
IT seems a more correct headlines would have read ''Company bribes Governor Perry to bury nuclear waste and contaminate Texas''. Waste Control Specialists. The company is owned by Harold Simmons, a ''TOP DONOR TO GOV. RICK PERRY, WHO APPOINTS MEMBERS TO THE TCEQ.'' The good governor has sold out to the citizens of Texas for train car, after train car of nuclear waste from 'the mound' Monsanto plant in Miamisburg Ohio. It just so happens, my father-in-law, who is down visiting now with us, has pictures of those railroad cars just sitting and waiting to come down to Texas. Odd how I was watching the news today, about this small plane that had crashed, it had showed pictures of where it had crashed right up near a bunch of tractor-trailer cargo container boxes in a parking lot. What would keep this from happening with those radioactive toxic containers in Ohio, at 'the mound', and or in route to Texas? You see, it's been killing my father-in-law, he has been on oxygen for years, but his breathing is getting more and more labored now, even with the oxygen. He worked at 'the mound' for years and years, and he is now dying a slow death from asbestosis, among other ailments caused by working at 'the mound'. NOW here is what I just cannot understand. This material is so toxic, in trying to gain further medical assistance from the DOE, the evidence that was needed to show that indeed my father-in-law worked their i.e. work records, paperwork records, payment records etc., they told my father-in-law, that they could not dig those records up, that they were buried due to high nuclear contamination, it was just too toxic, and that he had to prove that he had worked there. In which he did finally prove, and did gain further assistance. Also, ''Soward said a contested hearing could either rebut or support allegations that the agency ignored it's own scientific evidence that the site is geologically unsuitable to store material that will remain radioactive for tens of thousands of years.'' This is typical of the Bush Administration, and it happens all the time. The only science that the Bush administration knows, is junk science, bought and paid for by industry scientist. This has been proven time and time again ;
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations.
http://www.ucsusa.org/scientific_integrity/interference/a-to-z-alphabetical.html
Executive Summary
snip...
The Bush administration’s direct abuse of science—combined with systemic changes to the regulatory system that threaten the integrity of EPA science—highlight the need for strong action by the next president and Con- gress to restore scientific integrity to the agency’s decision making. Only then can the EPA fully mobilize to serve the public good and ensure the nation’s health.
Report: Federal Science and the Public Good
http://www.ucsusa.org/scientific_integrity/interference/interference-at-the-epa.html
posted February 19, 2004 (March 8, 2004 issue) The Junk Science of George W. Bush
The Bush Administration has so violated and corrupted the institutional culture of government agencies charged with scientific research that it could take a generation for them to recover their integrity even if Bush is defeated this fall. Says Princeton University scientist Michael Oppenheimer, "If you believe in a rational universe, in enlightenment, in knowledge and in a search for the truth, this White House is an absolute disaster." .....
February 18, 2004
Preeminent Scientists Protest Bush Administration's Misuse of Science Nobel Laureates, National Medal of Science Recipients, and Other Leading Researchers Call for End to Scientific Abuses .....
snip...
* National Medal of Science † Nobel laureate
http://www.ucsusa.org/news/press_release/preeminent-scientists-protest-bush-administrations-misuse-of-science.html
full text ;
http://sciencebushwhacked.blogspot.com/
http://sciencebushwhacked.blogspot.com/2008/05/junk-science-of-george-w-bush.html
My point is this, why in the world would the Governor of Texas make a sound decision on accepting this nuclear waste$ It's simply amazing what enough money can buy, even the Governor of Texas. ''TCEQ's executive director rejected their request, saying there is not sufficient public interest because no Texas residents sought a review.'' Well, I am one Texan that does not want any more Toxic waste in Texas, nuclear or not. Why should we take other states nuclear waste? Texas is NOT a nuclear dump for the highest bidder, the good Governor may think so, but myself and many others here in Texas just cannot accept this. This is insane, or just business as usual, make your choice. Governor Perry sold us all out, and he must be held accountable. ...
PART 1
Piketon: A troubled past Cold War factory created secret dump, set own rules By Lynn Hulsey, Tom Beyerlein
Staff Writer
Sunday, November 12, 2006
PIKETON — Inside the closely guarded confines of this 3,714-acre federal complex, deer lope along roadways, chubby groundhogs munch clover and wild turkeys gather during breeding season.
But this is no nature preserve.
Thousands of metal cylinders of corrosive radioactive waste — most weighing 14 tons and many heavily etched with rust — stretch across industrial yards.
Five plumes of poisoned groundwater lie beneath the surface, one of them so close to private land that traces of contamination were found in a monitoring well on a nearby farm.
Access is restricted inside three buildings that sprawl for more than a mile and are contaminated with radiation, beryllium, polychlorinated biphenyls (PCBs) and asbestos.
What dangers lie beneath the thick concrete floors of those buildings is anybody's guess.
Welcome to the old Piketon atomic plant 100 miles southeast of Dayton, once a proud monument to Ohio's nuclear legacy.
Today that legacy is one of mounting bills for U.S. taxpayers, an environmental cleanup that has no end in sight, and thousands of former workers or their survivors who sought compensation, claiming work-related cancers and other illnesses.
Government investigators blame problems at the now-closed Portsmouth Gaseous Diffusion Plant on decades of slipshod safety practices, accidental toxic releases and routine mishandling of chemical and radioactive material.
The cleanup cost at the uranium enrichment plant, estimated at $3 billion, could eventually top the $4.5 billion spent at the U.S. Department of Energy's former Feed Materials Production Center in Fernald, according to Ohio Environmental Protection Agency officials. That would make the Piketon cleanup the most expensive environmental reclamation project in Ohio history.
For decades, operators of the government-owned plant created a secret dump, spraying PCBs and uranium-contaminated oils on dusty roads, burying hazardous waste in unlined landfills, pouring toxins into waterways, allowing radioactive incinerator ash to scatter in the wind — even tilling radioactive oils into the ground.
Former workers told the Dayton Daily News chilling tales of a workplace in which managers downplayed risks, enforced a code of silence, and failed to protect employees against some of the most dangerous substances on earth.
Gary Sexton, 56, said he didn't know hazardous levels of the metal beryllium were in the plant when he started work as a chemical operator in 1974. He now has trouble breathing because of a potentially fatal and incurable ailment known as chronic beryllium disease that afflicted about 38 Piketon workers.
"Of the ones that have chronic beryllium disease, there are more dead than living," said Sexton, a safety representative for United Steelworkers Local 5689.
Donald Cruse, 65, said he was often sent to dismantle radiation-contaminated equipment and handle PCBs and asbestos without protective gear. He recently underwent surgery for melanoma, and breathes through a tube in his neck after losing part of his larynx to cancer.
"All the hottest places on the plant site, I worked," said Cruse, who was employed there from 1975 to 1996. "They said none of that would hurt us. There wasn't enough there to bother us."
Kenny Estep coached peewee football, was an auxiliary police officer and headed the local Moose Lodge. But in his job as a truck driver at the Piketon plant, Estep hauled radioactive waste to a plant landfill. On March 7, 1978, he was handed a respirator and a pair of paper coveralls and told to dump snow on a leaking cylinder full of radioactive uranium hexafluoride, the material used to enrich uranium.
He died of a rare form of liver cancer seven years later at the age of 42.
"He had a job to do and he was told to do it, so he did it," said Estep's widow, Barbara Barker, 62, of Piketon.
Barker received compensation for her husband's death, but it didn't come until after the federal government admitted for the first time in 1999 that it harmed its atomic workers.
The environmental damage at Piketon was harder to hide. The same hazards that sickened workers also poisoned the environment and continue to threaten future generations.
Along with the Mound Laboratory in Miamisburg, the plants at Fernald and Piketon once played indispensable roles in the manufacture of Cold War nuclear weapons. But the environmental footprint each of them left behind will never fully be erased, even after the billions of dollars spent cleaning contaminated groundwater, soil, waterways and buildings.
The end-date for monitoring the pollution at Piketon: never.
William E. Murphie, manager of the Energy Department office overseeing cleanup at Piketon and a sister plant in Paducah, Ky., declined to address Piketon's history of mishandling hazardous materials.
"We take a lot of lumps for the past processes and, face it, mistakes that were made," he said. "We've learned from the past. We're all smarter than we were in the past."
Murphie said the department remains committed to the cleanup and trying new solutions if those now in place don't work.
"DOE is very proud of the cleanup program here," he said. "We believe we have accomplished a lot."
Worker safety a low priority
From 1954-2001, the Piketon plant provided a ticket to the middle class for some 10,000 residents in Appalachian Ohio. A series of government contractors enriched uranium there, first for nuclear weapons and later to power nuclear reactors.
"The focus back then was to win the Cold War. Handling the waste and avoiding contamination was pretty low on the list," said Brian Blair, an Ohio EPA supervisor who participated in the state's first inspection of the site in 1986. "They were not managed even according to the best technology available at that time. That's why we have many of the contaminants out there."
The now-defunct Goodyear Atomic Corp. operated the Piketon plant for its first 32 years. A subsidiary of Martin Marietta took over management in 1986, followed by Lockheed Martin in 1995. The government privatized its enrichment operations in 1998, turning them over to USEC Inc. of Bethesda, Md.
In the early years, few environmental regulations existed across the United States and the hazards of chemical and radioactive materials weren't fully understood. By the 1970s, the government began regulating the handling and disposal of hazardous materials, and took action against companies that didn't follow the rules.
But unlike private companies, the Energy Department was allowed to set its own environmental standards, at least when it came to nuclear facilities such as Piketon. Energy officials, in effect, said, "trust us." Until the late 1980s, environmental regulators had no jurisdiction — or access — to the Piketon plant, and even now secrecy cloaks many plant practices.
All nuclear facilities must keep some practices confidential for reasons of national security. But the secrecy and self-regulation at Piketon veiled an astounding level of environmental destruction.
In 2000, the Energy Department secretary launched a massive investigation that documented the plant's grim environmental record: mishandling of hazardous and radioactive material, failure to properly monitor environmental emissions or workers' exposure to radiation, ignoring safety rules. The investigators identified 400 accidental releases of uranium gas or toxic fluorine since the 1950s, although they said the true total was unknown due to poor record keeping.
The worst of what the investigators found occurred in the plant's first 25 years, but careless and harmful practices continued even as the plant changed operators. For example:
• Two separate incidents — in 1982 and 1993 — resulted in the airborne release of 19 curies of radioactive technetium, a cancer-causing product of nuclear fission that escaped as workers cleaned equipment. "That's a significant amount, and it's certainly not desirable to have those kinds of releases in the air," Blair said.
• Uranium-contaminated solvents were burned in an incinerator designed for solids until 1986, when the Ohio EPA ordered it shut down. Maria Galanti, the agency's on-site coordinator, said soil around the incinerator site is radioactive at least 12 feet deep.
• The Energy Department didn't stop pumping waste into the plant's worst source of off-site and groundwater contamination until 1988. That unlined pond held everything from PCBs and the solvent trichloroethylene to radioactive uranium, technetium and plutonium — toxins that leached into groundwater and the Little Beaver Creek, a tributary of the Scioto River.
People who live near the plant say they had no idea all this was going on. Children swam in the creeks, and churches held baptisms in Big Run Creek. That same creek runs past two unlined landfills and near a polluted groundwater plume as it passes through the plant grounds on its way to the Scioto River.
Clyde Blanton has lived next to the plant's southern border since 1970. Not until the late 1980s, when residents near the Fernald plant began fighting for a cleanup there, did Blanton and others start asking questions about Piketon.
He said plant officials assured people it was safe.
"Now they've spent a billion bucks cleaning up," said Blanton, 64. "That tells you it's not safe. Somebody lied."
Inspectors react with shock
The cover over Piketon's secrets began to lift in 1986, when Ohio EPA inspectors were allowed inside the plant for the first time. What they saw shocked them.
In one of the plant's more egregious practices dating to the 1980s, plant operators tilled highly radioactive oils into soil, figuring the solvents would degrade over time. They didn't take into account that radiation takes millions, even billions of years to decay.
Those plots, now capped, are one of several sources of contaminants in the plant's second-largest groundwater plume.
"You had some of the best minds in the U.S. government working on enriching uranium and this is the best they could do with their waste?" Galanti said.
Plant operators dumped radioactive materials, toxic chemicals and dangerous solvents into unlined landfills and even discharged radioactive and chemical wastes into ditches leading to the Little Beaver Creek. Galanti described the ditches as "screaming hot" and said they were one of the Ohio EPA's top cleanup priorities.
The solvent trichloroethylene, a suspected carcinogen, remains the site's most pervasive groundwater contaminant.
"They'd go dump solvents out the back door," Galanti said. "And taking drums of degreasers and volatile organics and dumping them in a big pit."
Even after they were allowed to visit the plant, Ohio EPA officials were frustrated in their effort to force a cleanup. Officials at federal nuclear facilities had long argued that they were exempt from environmental rules concerning the handling and disposal of all hazardous materials, including any radioactive material.
"They thought they were above the law," said Jack Van Kley, the lead attorney in a federal court case that the state of Ohio filed in 1989 against the Energy Department.
As a result of that case, state regulators won limited authority over the department's operations at Piketon. A consent decree issued by the court required the Energy Department to follow state and federal rules for hazardous materials. But the department retained oversight of its handling of purely radioactive material.
A separate agreement was reached with the U.S. EPA, and cleanup began the same year.
Taxpayers are footing the cleanup bill because government contracts protected the contractors who ran the plant against damages, said Energy Department spokeswoman Laura Schachter. Four of those companies are defunct but their parent companies, Goodyear Corp. and Lockheed Martin Corp., are still in business. Goodyear spokesman Keith Price had no comment for this story. Lockheed Martin spokeswoman Gail E. Rymer said environmental investigations were already underway when the company's subsidiaries managed the site and those companies also assisted with cleanup.
"Since we took over the plant we have had an exemplary safety and environmental record," said USEC spokeswoman Elizabeth Stuckle.
So far, the government has spent $1 billion to dig up soil, empty ponds, cap unlined toxic landfills, treat groundwater and haul contaminants away — more than 43,000 containers of hazardous, radioactive and other waste and 8,400 tons of radioactive scrap metal.
Each year, the plant treats 28.5 million gallons of contaminated groundwater, said Sandra Childers, spokeswoman for LATA/Parallax Portsmouth, which last year replaced Bechtel Jacobs Co. as the Energy Department's cleanup contractor.
The 20,000 cylinders of depleted uranium hexafluoride — enrichment waste that piled up on the site over 50 years — will sit until they can be converted to a more stable form and shipped away. A conversion plant now under construction would eliminate the backlog by 2026, but more waste could be coming. USEC wants to replace the old gaseous diffusion plant with the American Centrifuge Plant, a high-tech uranium enrichment facility that would annually generate about 1,300 cylinders of waste.
Piketon is one of more than 100 polluted Energy Department sites across the United States. The department is the government's worst polluter, with a cleanup bill estimated at $35 billion, according to a 2004 U.S. EPA study.
But although the Piketon site is far from the Energy Department's worst offender, the sheer size of three massive enrichment buildings complicates cleanup and inflates the cost. Inside those buildings, giant machines heated uranium hexafluoride and forced it through filters to boost the concentration of the uranium isotope needed for reactor fuel and weapons.
Some of the most dangerous cleanup work is occurring in those structures. Under tight security, workers are removing uranium deposits that cling to surfaces inside equipment and 600 miles of piping. They must use extreme care because mishandling the radioactive deposits could cause a small nuclear reaction — a "criticality" — that could kill workers and spread radiation through the area.
"We've never had a criticality event, and I have no reason to believe that we ever will have a criticality event," Murphie said.
Groundwater contamination
a sore subject
The Piketon cleanup hasn't ended disputes between the Energy Department and its regulators. The Ohio EPA has fought Energy officials over everything from what to do with the thousands of contaminated cylinders at the site to the department's efforts to ease groundwater standards.
Memos obtained by the Dayton Daily News outline Ohio EPA officials' complaints about disputes over cleanup methods, wasteful spending by Energy Department contractors and botched cleanup jobs — in one instance allowing polluted groundwater to spread because of poor construction of a barrier wall.
Murphie declined to comment on the memos.
Groundwater contamination has been a flashpoint. In 1999, the Ohio EPA rejected an Energy Department attempt to cut disposal costs by loosening rules for the suspected carcinogen trichloroethylene, which permeates groundwater and has proven difficult to remove.
More recently, the department pushed for a reduced groundwater cleanup standard, arguing that the lesser standard is appropriate because no one drinks the water underneath the plant site.
"We represent the taxpayers. Our goal here is to make sure we are doing cost-effective, smart cleanup," Murphie said. "The regulators represent the taxpayers but also the regulators represent the regulations."
Ohio EPA officials are firm: There will be no reduced groundwater standard.
"We can't allow unlimited groundwater contamination just because they say it won't be used. That is a resource, and it does migrate and move," said Ken Dewey, the agency's southeast district assistant chief.
The latest point of friction between the Energy Department and its watchdogs involves the three enrichment buildings. The debate over what to do with them involves questions of money, jurisdiction and, ultimately, jobs.
Ohio EPA officials want the buildings — and the equipment inside of them — to be cleaned and demolished. It's unclear yet whether they can be safely buried at Piketon or must be shipped at great cost to disposal sites in Utah or Nevada.
Murphie has suggested still another possibility, that the contaminated buildings stay in place indefinitely under a long-term surveillance plan. But Dewey argues that leaving the structures in place will make cleanup more expensive in the long run because "we'll have to drill under and around buildings" to investigate and clean contaminated soil and groundwater.
"I hope the federal government doesn't make that choice," he said.
Even if Energy officials decide to demolish the buildings, there is one major obstacle: money.
A fund for cleaning enrichment plants in Ohio, Tennessee and Kentucky will fall as much as $5.7 billion short of what is needed to clean all three sites, according to a 2004 report by the U.S. Government Accountability Office.
The Energy Department's five-year cleanup plan shows a decline in funding for the Piketon cleanup and no money for demolition of the enrichment buildings.
Local officials, who have watched jobs disappear through the years, worry that a stalled cleanup plan will reduce current employment and derail efforts to redevelop the site.
"Now we're threatened," said Blaine Beekman, executive director of the Pike County Chamber of Commerce. "It's like every day there's a new chapter, a new battle to fight."
Concerned neighbors
take cancer survey
After denying for years that its nuclear operations harmed anyone, the federal government in 2000 launched a program to compensate atomic workers sickened by workplace exposures. So far, more than 2,900 Piketon workers or their survivors have applied for the money.
But if people inside the plant got sick, what about those outside?
In 1994, a local residents group went door-to-door and identified 247 cancer cases within a six-mile radius of the plant. The data, however, was incomplete. The volunteers did not collect information on important risk factors, such as smoking status and occupational exposures, and failed to confirm the diagnoses with medical records.
"These limitations make it difficult to generate meaningful cancer rates from these data," a federal health assessment concluded two years later. That assessment, done by the federal Agency for Toxic Substances and Disease Registry in response to residents' concerns, found that the plant posed "no off-site threat to public health."
Critics were quick to point out inaccuracies in the government report, and continue to dispute the overall finding.
"I think they're wrong with the risk," said Vina Colley, president of a local watchdog group and a former Piketon employee fighting for compensation for illnesses she believes were caused by workplace exposures.
Ohio EPA officials say the worst of the plant's contamination is confined to the federal land, in part because thick bedrock slows the spread of the poisoned groundwater. They also say the plant's environmental record improved in recent years as operators adopted modern waste-handling practices and began following rules governing discharges to air and waterways.
Still, evidence of off-site contamination remained even after enrichment operations shut down in 2001. According to its most recent environmental reports, the Energy Department in 2003 and 2004 found small amounts of radioactive contamination outside the plant.
Tests on two area deer killed by cars showed traces of uranium isotopes in the livers of both and in the muscle of one. Traces of uranium were also found in milk and egg samples from area farms, and in three vegetables taken from the gardens of plant neighbors. Air, water and sediment tests also revealed small amounts of radioactive uranium, plutonium or technetium. And three fish from area waterways had traces of uranium or plutonium. Because plutonium rarely occurs naturally, there would appear to be only one possible source: the plant.
Energy officials say none of the amounts are large enough to pose a health threat.
Activists accuse the department of minimizing the threat of off-site radioactive contamination. Noting that a fish from the Little Beaver Creek contained trace amounts of plutonium, Elisa Young of the Sierra Club's Appalachian Group asked, "Would you eat that fish?"
Although the radiation amounts detected in recent years are small, Galanti said it's impossible to know how many contaminants were carried off by the wind or waterways over the years.
"It went somewhere," she said. "We all live downstream in one aspect or another."
With polluted government nuclear facilities dotting the map from coast to coast, Galanti said the abysmal environmental record has left a legacy of phenomenal costs and immense responsibilities for future generations.
"How do we monitor this stuff in perpetuity?" she said. "That's a relic of the Cold War and our thirst for energy."
By M.J.Kraft
November 20, 2006 06:28 PM Link to this
I hired on at Mound 1980 entry level ,{labor gang].Assignments ranging from ,office moves,,assisting skilled trades in and out of contaminated areas, yards and grounds,and digging lots of holes.In 1986 I moved up to Firefighter classification. Fire prevention was top priority.For the 13 years myself, and 8 other firefighters perforfmed ispections over every inch of every building. Hot or cold. In 1990 I was diagnosed with COPD,1994Moderate Emphysema,Lung Cancer 2006.Do yourself A favor
By Mary M.
November 19, 2006 08:14 PM Link to this
Investigative reporting at it finest (and most expensive) so it isn’t often seen in daily newspapers. I am a Mound widow and also a Mound survivor as I worked on the “cool” side. At age 81 I consider myself very, very lucky.
By Paige Gibson
November 16, 2006 08:19 AM Link to this
I worked at Mound as did my father. I became aware of the occpational exposure and got involved. I now work for Mound Workers Health Protection Program. We offer Mound workers a free medical screening. Since July we have diagnosed 6 people with lung cancer or asbestosis. We are also helping people with their claims. What a mess! So Mound people if you have questions or comments call us at 937-866-6802.
By Carolyn
November 14, 2006 09:39 PM Link to this
Excellent series. Your series and others in papers near other sites where atomic workers worked and became ill should be circulated in each community so readers know the situation in the local plant was repeated over and over all over the country.
These plants, not to mention the bombs they helped create, were the American weapons of mass destruction of several generations of workers.
By WALT
November 14, 2006 09:15 PM Link to this
I WORKED AT MOUND FOR 36 YEARS IN SOME OF THE MOST HAZARDOUS CONDITIONS. I AM NOW PAYING THE PRICE WITH CHRONIC INCURABLE LUNG DISEASE. I AM TRYING TO WORK MY WAY THRU THE PAPER WORKMILL WHICH STARTED OVER 2 YEARS AGO.
By Bill Bankes
November 14, 2006 12:17 PM Link to this
I worked at Mound and my Grandfather worked at Fernald, Waverly, and GE Evendale. He died in 1963 of Cancer caused by exposure.
His claim was denied because they would not accept his time at GE and a site to be included although there were large amounts of radioactive materials there.
By Jodi Hingtgen
November 13, 2006 09:48 PM Link to this
Is anyone keeping a central repository or database of people who worked at the Mound and have since died of unnatural causes? Anyone other than the government? My mother (Doris Hill) worked there between 1956 and 1963 and died of various cancers when she was only 42 and I was 16. NIOSH has so far denied my claims. Any information on people who worked there in the late 50’ s and early 60’s would be be greatly appreciated.
Thanks, Jodi
http://www.daytondailynews.com/n/content/oh/story/news/special-reports/piketon/2006/11/11/ddn111206pkcleanup.html
LETTER ABOUT MOUND PLANT'S DEADLY LEGACY
Publication: Dayton Daily News Publish date: October 30, 2010
How was Mound Laboratory allowed to do so much harm?
I'd like to provide some first-hand information regarding the "environmental devastation" created by the Mound Laboratory during the years that my family lived on Mound Road.
In 1956, my parents bought a new home in a lovely neighborhood for their growing family. I lived there until 1966.
Beginning in 1960, the Mound released radioactive tritium into the air and contaminated the soil with plutonium-238. Our city water supply was piped up Mound hill; we played at the Adena Indian mound, spent countless hours at the Miamisburg public pool and fished in the pond.
My father worked at Presto Adhesive Paper, below Mound Lab, on Mound Avenue. He died at the age of 53 of a rare cancer multiple myeloma.
Our mother had already undergone radical mastectomy and radiation for breast cancer prior to age 50; she would later die of mesothelioma.
Our older brother died in his early sixties of bladder cancer, and my daughter had her cancerous left kidney removed while in her mid-thirties.
My family's experiences are only a small part of our neighborhood cancer history. Beginning with Mound Road, spreading back Marsha Drive and all along Meadowview Drive, one - and in most households, both - parent experienced different types of malignant disease, i.e.: multiple breast and colon cancers, parotid tumor, bladder, prostate, lung, skin, mesothelioma, brain, aplastic anemia and a child with leukemia.
I estimate that cancer occurred in 90% of the households in that neighborhood.
How did city officials allow this to happen? Where were our environmental watchdogs from the 1970s until 1989, when the Mound plant was placed on the EPA priorities list? My family and our neighbors deserve answers to those questions.
Sally Nunery Dunn
West Carrollton
A MOUND OF NUCLEAR LIES AND DEATH COMING TO TEXAS thanks to Governor Perry $$$
The Mound faclity reportedly sent 458 boxes of plant records to Los Alamos in 1993. these records were found to be contaminated with radiation and buried at Los Alamos as a health hazard. One cannot but guess what these records contained. The most significant fact being that these records were considered a health threat from uptake of radioactive particulate. This does not speak well for the historical hygiene at the facility
snip...
A bldg was administration, B was biology, C was cafeteria, D was decontamination a hot bldg. -lots of water that they tried to wash the facility with and contaminated the regional aquifer, had -to remove tons of dirt. R building was radioactive and hot. A young man got so exposed to -radiation in the T building that he died in the medical facility. The T building was far underground.
http://www.cdc.gov/niosh/ocas/pdfs/sec/mound/mound2pet.pdf
Over time, contamination leaked from these drums into the surrounding soils ...... Mound Plant OU 1 Site. Location:. Miamisburg, OH. Period of Operation: ...
http://www.frtr.gov/pdf/abstractsvol5.pdf
Air Sparging and Soil Vapor Extraction at the Mound Plant OU 1 Site, Miamisburg, Ohio 73 Costs: • The total cost for AS/SVE was $1,439,039, consisting of $116,773 for pilot testing, $221,591 for design, $398,000 for construction, $517,958 for operations, and $184,717 for sampling and analysis • As of May 2000, the overall unit cost was $420 per pound of contaminant removed Description: The Mound Plant is a government-owned and contractor-operated facility occupying a 306-acre site within the city of Miamisburg, Ohio. The OU 1 site occupies three acres on the western edge of the developed portion of the facility. The historic landfill in OU 1 was used between 1948 and 1974 for disposal of general trash and liquid wastes from Mound Plant operations. The sanitary landfill in OU 1 was constructed partially within and adjacent to the location of the historic landfill. Both disposal sites have been used for dumping, burning, moving, reworking, and burying various plant wastes. A periodic water sampling program and a Phase 1 investigation indicated that VOCS were present in the soil and groundwater at OU 1. An air sparging and soil vapor extraction (AS/SVE) system began operating at OU 1 in December 1997. The system was intended to remove chlorinated VOCs from the soil and groundwater at the site. After 2 ½ years of operation, 3,433 lbs of VOCs had been removed, and the total VOC concentrations in the unsaturated zone decreased from 618.1 to 4.54 mg/kg. If system performance is maintained, the site was projected to meet cleanup goals by December 2002. The total cost for AS/SVE at this site was $1,439,039.
http://www.frtr.gov/pdf/abstractsvol5.pdf
COMING TO TEXAS, at a nuclear dump site near somebody, thanks to the good governor perry of Texas and a lot of $$$
Thanks Gov. ...
P.S. Suggestion; I say if it must come to Texas, send all toxic nuclear waste material to Bush Ranch, Crawford, Texas USA.
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net]
Sent: Thursday, May 22, 2008 5:01 PM To: janet.elliott@chron.com Cc: viewpoints@chron.com; tbeyerlein@DaytonDailyNews.com
Subject: re-Company wins license to bury nuclear waste
re-Company wins license to bury nuclear waste Houston Chronicle May 22, 2008
AUSTIN — State environmental regulators voted 2-1 Wednesday to grant a Dallas company a license to dispose of waste from nuclear weapons processing and uranium mining in Andrews County in West Texas.
Texas Commission on Environmental Quality Chairman Buddy Garcia and Commissioner Bryan Shaw voted to issue the "by-products" license to Waste Control Specialists. The company is owned by Harold Simmons, a top donor to Gov. Rick Perry, who appoints members to the TCEQ.
http://www.chron.com/disp/story.mpl/metropolitan/5795238.html
http://www.chron.com/disp/commnts.mpl/metropolitan/5795238.html?plckCurrentPage=2
IT seems a more correct headlines would have read ''Company bribes Governor Perry to bury nuclear waste and contaminate Texas''. Waste Control Specialists. The company is owned by Harold Simmons, a ''TOP DONOR TO GOV. RICK PERRY, WHO APPOINTS MEMBERS TO THE TCEQ.'' The good governor has sold out to the citizens of Texas for train car, after train car of nuclear waste from 'the mound' Monsanto plant in Miamisburg Ohio. It just so happens, my father-in-law, who is down visiting now with us, has pictures of those railroad cars just sitting and waiting to come down to Texas. Odd how I was watching the news today, about this small plane that had crashed, it had showed pictures of where it had crashed right up near a bunch of tractor-trailer cargo container boxes in a parking lot. What would keep this from happening with those radioactive toxic containers in Ohio, at 'the mound', and or in route to Texas? You see, it's been killing my father-in-law, he has been on oxygen for years, but his breathing is getting more and more labored now, even with the oxygen. He worked at 'the mound' for years and years, and he is now dying a slow death from asbestosis, among other ailments caused by working at 'the mound'. NOW here is what I just cannot understand. This material is so toxic, in trying to gain further medical assistance from the DOE, the evidence that was needed to show that indeed my father-in-law worked their i.e. work records, paperwork records, payment records etc., they told my father-in-law, that they could not dig those records up, that they were buried due to high nuclear contamination, it was just too toxic, and that he had to prove that he had worked there. In which he did finally prove, and did gain further assistance. Also, ''Soward said a contested hearing could either rebut or support allegations that the agency ignored it's own scientific evidence that the site is geologically unsuitable to store material that will remain radioactive for tens of thousands of years.'' This is typical of the Bush Administration, and it happens all the time. The only science that the Bush administration knows, is junk science, bought and paid for by industry scientist. This has been proven time and time again ;
Reports and Research
Interference at the EPA
Science and Politics at the U.S. Environmental Protection Agency
The results of these investigations show an agency under siege from political pressures. On numerous issues—ranging from mercury pollution to groundwater contamination to climate change—political appointees have edited scientific documents, manipulated scientific assessments, and generally sought to undermine the science behind dozens of EPA regulations.
http://www.ucsusa.org/scientific_integrity/interference/a-to-z-alphabetical.html
Executive Summary
snip...
The Bush administration’s direct abuse of science—combined with systemic changes to the regulatory system that threaten the integrity of EPA science—highlight the need for strong action by the next president and Con- gress to restore scientific integrity to the agency’s decision making. Only then can the EPA fully mobilize to serve the public good and ensure the nation’s health.
Report: Federal Science and the Public Good
http://www.ucsusa.org/scientific_integrity/interference/interference-at-the-epa.html
posted February 19, 2004 (March 8, 2004 issue) The Junk Science of George W. Bush
The Bush Administration has so violated and corrupted the institutional culture of government agencies charged with scientific research that it could take a generation for them to recover their integrity even if Bush is defeated this fall. Says Princeton University scientist Michael Oppenheimer, "If you believe in a rational universe, in enlightenment, in knowledge and in a search for the truth, this White House is an absolute disaster." .....
February 18, 2004
Preeminent Scientists Protest Bush Administration's Misuse of Science Nobel Laureates, National Medal of Science Recipients, and Other Leading Researchers Call for End to Scientific Abuses .....
snip...
* National Medal of Science † Nobel laureate
http://www.ucsusa.org/news/press_release/preeminent-scientists-protest-bush-administrations-misuse-of-science.html
full text ;
http://sciencebushwhacked.blogspot.com/
http://sciencebushwhacked.blogspot.com/2008/05/junk-science-of-george-w-bush.html
My point is this, why in the world would the Governor of Texas make a sound decision on accepting this nuclear waste$ It's simply amazing what enough money can buy, even the Governor of Texas. ''TCEQ's executive director rejected their request, saying there is not sufficient public interest because no Texas residents sought a review.'' Well, I am one Texan that does not want any more Toxic waste in Texas, nuclear or not. Why should we take other states nuclear waste? Texas is NOT a nuclear dump for the highest bidder, the good Governor may think so, but myself and many others here in Texas just cannot accept this. This is insane, or just business as usual, make your choice. Governor Perry sold us all out, and he must be held accountable. ...
PART 1
Piketon: A troubled past Cold War factory created secret dump, set own rules By Lynn Hulsey, Tom Beyerlein
Staff Writer
Sunday, November 12, 2006
PIKETON — Inside the closely guarded confines of this 3,714-acre federal complex, deer lope along roadways, chubby groundhogs munch clover and wild turkeys gather during breeding season.
But this is no nature preserve.
Thousands of metal cylinders of corrosive radioactive waste — most weighing 14 tons and many heavily etched with rust — stretch across industrial yards.
Five plumes of poisoned groundwater lie beneath the surface, one of them so close to private land that traces of contamination were found in a monitoring well on a nearby farm.
Access is restricted inside three buildings that sprawl for more than a mile and are contaminated with radiation, beryllium, polychlorinated biphenyls (PCBs) and asbestos.
What dangers lie beneath the thick concrete floors of those buildings is anybody's guess.
Welcome to the old Piketon atomic plant 100 miles southeast of Dayton, once a proud monument to Ohio's nuclear legacy.
Today that legacy is one of mounting bills for U.S. taxpayers, an environmental cleanup that has no end in sight, and thousands of former workers or their survivors who sought compensation, claiming work-related cancers and other illnesses.
Government investigators blame problems at the now-closed Portsmouth Gaseous Diffusion Plant on decades of slipshod safety practices, accidental toxic releases and routine mishandling of chemical and radioactive material.
The cleanup cost at the uranium enrichment plant, estimated at $3 billion, could eventually top the $4.5 billion spent at the U.S. Department of Energy's former Feed Materials Production Center in Fernald, according to Ohio Environmental Protection Agency officials. That would make the Piketon cleanup the most expensive environmental reclamation project in Ohio history.
For decades, operators of the government-owned plant created a secret dump, spraying PCBs and uranium-contaminated oils on dusty roads, burying hazardous waste in unlined landfills, pouring toxins into waterways, allowing radioactive incinerator ash to scatter in the wind — even tilling radioactive oils into the ground.
Former workers told the Dayton Daily News chilling tales of a workplace in which managers downplayed risks, enforced a code of silence, and failed to protect employees against some of the most dangerous substances on earth.
Gary Sexton, 56, said he didn't know hazardous levels of the metal beryllium were in the plant when he started work as a chemical operator in 1974. He now has trouble breathing because of a potentially fatal and incurable ailment known as chronic beryllium disease that afflicted about 38 Piketon workers.
"Of the ones that have chronic beryllium disease, there are more dead than living," said Sexton, a safety representative for United Steelworkers Local 5689.
Donald Cruse, 65, said he was often sent to dismantle radiation-contaminated equipment and handle PCBs and asbestos without protective gear. He recently underwent surgery for melanoma, and breathes through a tube in his neck after losing part of his larynx to cancer.
"All the hottest places on the plant site, I worked," said Cruse, who was employed there from 1975 to 1996. "They said none of that would hurt us. There wasn't enough there to bother us."
Kenny Estep coached peewee football, was an auxiliary police officer and headed the local Moose Lodge. But in his job as a truck driver at the Piketon plant, Estep hauled radioactive waste to a plant landfill. On March 7, 1978, he was handed a respirator and a pair of paper coveralls and told to dump snow on a leaking cylinder full of radioactive uranium hexafluoride, the material used to enrich uranium.
He died of a rare form of liver cancer seven years later at the age of 42.
"He had a job to do and he was told to do it, so he did it," said Estep's widow, Barbara Barker, 62, of Piketon.
Barker received compensation for her husband's death, but it didn't come until after the federal government admitted for the first time in 1999 that it harmed its atomic workers.
The environmental damage at Piketon was harder to hide. The same hazards that sickened workers also poisoned the environment and continue to threaten future generations.
Along with the Mound Laboratory in Miamisburg, the plants at Fernald and Piketon once played indispensable roles in the manufacture of Cold War nuclear weapons. But the environmental footprint each of them left behind will never fully be erased, even after the billions of dollars spent cleaning contaminated groundwater, soil, waterways and buildings.
The end-date for monitoring the pollution at Piketon: never.
William E. Murphie, manager of the Energy Department office overseeing cleanup at Piketon and a sister plant in Paducah, Ky., declined to address Piketon's history of mishandling hazardous materials.
"We take a lot of lumps for the past processes and, face it, mistakes that were made," he said. "We've learned from the past. We're all smarter than we were in the past."
Murphie said the department remains committed to the cleanup and trying new solutions if those now in place don't work.
"DOE is very proud of the cleanup program here," he said. "We believe we have accomplished a lot."
Worker safety a low priority
From 1954-2001, the Piketon plant provided a ticket to the middle class for some 10,000 residents in Appalachian Ohio. A series of government contractors enriched uranium there, first for nuclear weapons and later to power nuclear reactors.
"The focus back then was to win the Cold War. Handling the waste and avoiding contamination was pretty low on the list," said Brian Blair, an Ohio EPA supervisor who participated in the state's first inspection of the site in 1986. "They were not managed even according to the best technology available at that time. That's why we have many of the contaminants out there."
The now-defunct Goodyear Atomic Corp. operated the Piketon plant for its first 32 years. A subsidiary of Martin Marietta took over management in 1986, followed by Lockheed Martin in 1995. The government privatized its enrichment operations in 1998, turning them over to USEC Inc. of Bethesda, Md.
In the early years, few environmental regulations existed across the United States and the hazards of chemical and radioactive materials weren't fully understood. By the 1970s, the government began regulating the handling and disposal of hazardous materials, and took action against companies that didn't follow the rules.
But unlike private companies, the Energy Department was allowed to set its own environmental standards, at least when it came to nuclear facilities such as Piketon. Energy officials, in effect, said, "trust us." Until the late 1980s, environmental regulators had no jurisdiction — or access — to the Piketon plant, and even now secrecy cloaks many plant practices.
All nuclear facilities must keep some practices confidential for reasons of national security. But the secrecy and self-regulation at Piketon veiled an astounding level of environmental destruction.
In 2000, the Energy Department secretary launched a massive investigation that documented the plant's grim environmental record: mishandling of hazardous and radioactive material, failure to properly monitor environmental emissions or workers' exposure to radiation, ignoring safety rules. The investigators identified 400 accidental releases of uranium gas or toxic fluorine since the 1950s, although they said the true total was unknown due to poor record keeping.
The worst of what the investigators found occurred in the plant's first 25 years, but careless and harmful practices continued even as the plant changed operators. For example:
• Two separate incidents — in 1982 and 1993 — resulted in the airborne release of 19 curies of radioactive technetium, a cancer-causing product of nuclear fission that escaped as workers cleaned equipment. "That's a significant amount, and it's certainly not desirable to have those kinds of releases in the air," Blair said.
• Uranium-contaminated solvents were burned in an incinerator designed for solids until 1986, when the Ohio EPA ordered it shut down. Maria Galanti, the agency's on-site coordinator, said soil around the incinerator site is radioactive at least 12 feet deep.
• The Energy Department didn't stop pumping waste into the plant's worst source of off-site and groundwater contamination until 1988. That unlined pond held everything from PCBs and the solvent trichloroethylene to radioactive uranium, technetium and plutonium — toxins that leached into groundwater and the Little Beaver Creek, a tributary of the Scioto River.
People who live near the plant say they had no idea all this was going on. Children swam in the creeks, and churches held baptisms in Big Run Creek. That same creek runs past two unlined landfills and near a polluted groundwater plume as it passes through the plant grounds on its way to the Scioto River.
Clyde Blanton has lived next to the plant's southern border since 1970. Not until the late 1980s, when residents near the Fernald plant began fighting for a cleanup there, did Blanton and others start asking questions about Piketon.
He said plant officials assured people it was safe.
"Now they've spent a billion bucks cleaning up," said Blanton, 64. "That tells you it's not safe. Somebody lied."
Inspectors react with shock
The cover over Piketon's secrets began to lift in 1986, when Ohio EPA inspectors were allowed inside the plant for the first time. What they saw shocked them.
In one of the plant's more egregious practices dating to the 1980s, plant operators tilled highly radioactive oils into soil, figuring the solvents would degrade over time. They didn't take into account that radiation takes millions, even billions of years to decay.
Those plots, now capped, are one of several sources of contaminants in the plant's second-largest groundwater plume.
"You had some of the best minds in the U.S. government working on enriching uranium and this is the best they could do with their waste?" Galanti said.
Plant operators dumped radioactive materials, toxic chemicals and dangerous solvents into unlined landfills and even discharged radioactive and chemical wastes into ditches leading to the Little Beaver Creek. Galanti described the ditches as "screaming hot" and said they were one of the Ohio EPA's top cleanup priorities.
The solvent trichloroethylene, a suspected carcinogen, remains the site's most pervasive groundwater contaminant.
"They'd go dump solvents out the back door," Galanti said. "And taking drums of degreasers and volatile organics and dumping them in a big pit."
Even after they were allowed to visit the plant, Ohio EPA officials were frustrated in their effort to force a cleanup. Officials at federal nuclear facilities had long argued that they were exempt from environmental rules concerning the handling and disposal of all hazardous materials, including any radioactive material.
"They thought they were above the law," said Jack Van Kley, the lead attorney in a federal court case that the state of Ohio filed in 1989 against the Energy Department.
As a result of that case, state regulators won limited authority over the department's operations at Piketon. A consent decree issued by the court required the Energy Department to follow state and federal rules for hazardous materials. But the department retained oversight of its handling of purely radioactive material.
A separate agreement was reached with the U.S. EPA, and cleanup began the same year.
Taxpayers are footing the cleanup bill because government contracts protected the contractors who ran the plant against damages, said Energy Department spokeswoman Laura Schachter. Four of those companies are defunct but their parent companies, Goodyear Corp. and Lockheed Martin Corp., are still in business. Goodyear spokesman Keith Price had no comment for this story. Lockheed Martin spokeswoman Gail E. Rymer said environmental investigations were already underway when the company's subsidiaries managed the site and those companies also assisted with cleanup.
"Since we took over the plant we have had an exemplary safety and environmental record," said USEC spokeswoman Elizabeth Stuckle.
So far, the government has spent $1 billion to dig up soil, empty ponds, cap unlined toxic landfills, treat groundwater and haul contaminants away — more than 43,000 containers of hazardous, radioactive and other waste and 8,400 tons of radioactive scrap metal.
Each year, the plant treats 28.5 million gallons of contaminated groundwater, said Sandra Childers, spokeswoman for LATA/Parallax Portsmouth, which last year replaced Bechtel Jacobs Co. as the Energy Department's cleanup contractor.
The 20,000 cylinders of depleted uranium hexafluoride — enrichment waste that piled up on the site over 50 years — will sit until they can be converted to a more stable form and shipped away. A conversion plant now under construction would eliminate the backlog by 2026, but more waste could be coming. USEC wants to replace the old gaseous diffusion plant with the American Centrifuge Plant, a high-tech uranium enrichment facility that would annually generate about 1,300 cylinders of waste.
Piketon is one of more than 100 polluted Energy Department sites across the United States. The department is the government's worst polluter, with a cleanup bill estimated at $35 billion, according to a 2004 U.S. EPA study.
But although the Piketon site is far from the Energy Department's worst offender, the sheer size of three massive enrichment buildings complicates cleanup and inflates the cost. Inside those buildings, giant machines heated uranium hexafluoride and forced it through filters to boost the concentration of the uranium isotope needed for reactor fuel and weapons.
Some of the most dangerous cleanup work is occurring in those structures. Under tight security, workers are removing uranium deposits that cling to surfaces inside equipment and 600 miles of piping. They must use extreme care because mishandling the radioactive deposits could cause a small nuclear reaction — a "criticality" — that could kill workers and spread radiation through the area.
"We've never had a criticality event, and I have no reason to believe that we ever will have a criticality event," Murphie said.
Groundwater contamination
a sore subject
The Piketon cleanup hasn't ended disputes between the Energy Department and its regulators. The Ohio EPA has fought Energy officials over everything from what to do with the thousands of contaminated cylinders at the site to the department's efforts to ease groundwater standards.
Memos obtained by the Dayton Daily News outline Ohio EPA officials' complaints about disputes over cleanup methods, wasteful spending by Energy Department contractors and botched cleanup jobs — in one instance allowing polluted groundwater to spread because of poor construction of a barrier wall.
Murphie declined to comment on the memos.
Groundwater contamination has been a flashpoint. In 1999, the Ohio EPA rejected an Energy Department attempt to cut disposal costs by loosening rules for the suspected carcinogen trichloroethylene, which permeates groundwater and has proven difficult to remove.
More recently, the department pushed for a reduced groundwater cleanup standard, arguing that the lesser standard is appropriate because no one drinks the water underneath the plant site.
"We represent the taxpayers. Our goal here is to make sure we are doing cost-effective, smart cleanup," Murphie said. "The regulators represent the taxpayers but also the regulators represent the regulations."
Ohio EPA officials are firm: There will be no reduced groundwater standard.
"We can't allow unlimited groundwater contamination just because they say it won't be used. That is a resource, and it does migrate and move," said Ken Dewey, the agency's southeast district assistant chief.
The latest point of friction between the Energy Department and its watchdogs involves the three enrichment buildings. The debate over what to do with them involves questions of money, jurisdiction and, ultimately, jobs.
Ohio EPA officials want the buildings — and the equipment inside of them — to be cleaned and demolished. It's unclear yet whether they can be safely buried at Piketon or must be shipped at great cost to disposal sites in Utah or Nevada.
Murphie has suggested still another possibility, that the contaminated buildings stay in place indefinitely under a long-term surveillance plan. But Dewey argues that leaving the structures in place will make cleanup more expensive in the long run because "we'll have to drill under and around buildings" to investigate and clean contaminated soil and groundwater.
"I hope the federal government doesn't make that choice," he said.
Even if Energy officials decide to demolish the buildings, there is one major obstacle: money.
A fund for cleaning enrichment plants in Ohio, Tennessee and Kentucky will fall as much as $5.7 billion short of what is needed to clean all three sites, according to a 2004 report by the U.S. Government Accountability Office.
The Energy Department's five-year cleanup plan shows a decline in funding for the Piketon cleanup and no money for demolition of the enrichment buildings.
Local officials, who have watched jobs disappear through the years, worry that a stalled cleanup plan will reduce current employment and derail efforts to redevelop the site.
"Now we're threatened," said Blaine Beekman, executive director of the Pike County Chamber of Commerce. "It's like every day there's a new chapter, a new battle to fight."
Concerned neighbors
take cancer survey
After denying for years that its nuclear operations harmed anyone, the federal government in 2000 launched a program to compensate atomic workers sickened by workplace exposures. So far, more than 2,900 Piketon workers or their survivors have applied for the money.
But if people inside the plant got sick, what about those outside?
In 1994, a local residents group went door-to-door and identified 247 cancer cases within a six-mile radius of the plant. The data, however, was incomplete. The volunteers did not collect information on important risk factors, such as smoking status and occupational exposures, and failed to confirm the diagnoses with medical records.
"These limitations make it difficult to generate meaningful cancer rates from these data," a federal health assessment concluded two years later. That assessment, done by the federal Agency for Toxic Substances and Disease Registry in response to residents' concerns, found that the plant posed "no off-site threat to public health."
Critics were quick to point out inaccuracies in the government report, and continue to dispute the overall finding.
"I think they're wrong with the risk," said Vina Colley, president of a local watchdog group and a former Piketon employee fighting for compensation for illnesses she believes were caused by workplace exposures.
Ohio EPA officials say the worst of the plant's contamination is confined to the federal land, in part because thick bedrock slows the spread of the poisoned groundwater. They also say the plant's environmental record improved in recent years as operators adopted modern waste-handling practices and began following rules governing discharges to air and waterways.
Still, evidence of off-site contamination remained even after enrichment operations shut down in 2001. According to its most recent environmental reports, the Energy Department in 2003 and 2004 found small amounts of radioactive contamination outside the plant.
Tests on two area deer killed by cars showed traces of uranium isotopes in the livers of both and in the muscle of one. Traces of uranium were also found in milk and egg samples from area farms, and in three vegetables taken from the gardens of plant neighbors. Air, water and sediment tests also revealed small amounts of radioactive uranium, plutonium or technetium. And three fish from area waterways had traces of uranium or plutonium. Because plutonium rarely occurs naturally, there would appear to be only one possible source: the plant.
Energy officials say none of the amounts are large enough to pose a health threat.
Activists accuse the department of minimizing the threat of off-site radioactive contamination. Noting that a fish from the Little Beaver Creek contained trace amounts of plutonium, Elisa Young of the Sierra Club's Appalachian Group asked, "Would you eat that fish?"
Although the radiation amounts detected in recent years are small, Galanti said it's impossible to know how many contaminants were carried off by the wind or waterways over the years.
"It went somewhere," she said. "We all live downstream in one aspect or another."
With polluted government nuclear facilities dotting the map from coast to coast, Galanti said the abysmal environmental record has left a legacy of phenomenal costs and immense responsibilities for future generations.
"How do we monitor this stuff in perpetuity?" she said. "That's a relic of the Cold War and our thirst for energy."
By M.J.Kraft
November 20, 2006 06:28 PM Link to this
I hired on at Mound 1980 entry level ,{labor gang].Assignments ranging from ,office moves,,assisting skilled trades in and out of contaminated areas, yards and grounds,and digging lots of holes.In 1986 I moved up to Firefighter classification. Fire prevention was top priority.For the 13 years myself, and 8 other firefighters perforfmed ispections over every inch of every building. Hot or cold. In 1990 I was diagnosed with COPD,1994Moderate Emphysema,Lung Cancer 2006.Do yourself A favor
By Mary M.
November 19, 2006 08:14 PM Link to this
Investigative reporting at it finest (and most expensive) so it isn’t often seen in daily newspapers. I am a Mound widow and also a Mound survivor as I worked on the “cool” side. At age 81 I consider myself very, very lucky.
By Paige Gibson
November 16, 2006 08:19 AM Link to this
I worked at Mound as did my father. I became aware of the occpational exposure and got involved. I now work for Mound Workers Health Protection Program. We offer Mound workers a free medical screening. Since July we have diagnosed 6 people with lung cancer or asbestosis. We are also helping people with their claims. What a mess! So Mound people if you have questions or comments call us at 937-866-6802.
By Carolyn
November 14, 2006 09:39 PM Link to this
Excellent series. Your series and others in papers near other sites where atomic workers worked and became ill should be circulated in each community so readers know the situation in the local plant was repeated over and over all over the country.
These plants, not to mention the bombs they helped create, were the American weapons of mass destruction of several generations of workers.
By WALT
November 14, 2006 09:15 PM Link to this
I WORKED AT MOUND FOR 36 YEARS IN SOME OF THE MOST HAZARDOUS CONDITIONS. I AM NOW PAYING THE PRICE WITH CHRONIC INCURABLE LUNG DISEASE. I AM TRYING TO WORK MY WAY THRU THE PAPER WORKMILL WHICH STARTED OVER 2 YEARS AGO.
By Bill Bankes
November 14, 2006 12:17 PM Link to this
I worked at Mound and my Grandfather worked at Fernald, Waverly, and GE Evendale. He died in 1963 of Cancer caused by exposure.
His claim was denied because they would not accept his time at GE and a site to be included although there were large amounts of radioactive materials there.
By Jodi Hingtgen
November 13, 2006 09:48 PM Link to this
Is anyone keeping a central repository or database of people who worked at the Mound and have since died of unnatural causes? Anyone other than the government? My mother (Doris Hill) worked there between 1956 and 1963 and died of various cancers when she was only 42 and I was 16. NIOSH has so far denied my claims. Any information on people who worked there in the late 50’ s and early 60’s would be be greatly appreciated.
Thanks, Jodi
http://www.daytondailynews.com/n/content/oh/story/news/special-reports/piketon/2006/11/11/ddn111206pkcleanup.html
LETTER ABOUT MOUND PLANT'S DEADLY LEGACY
Publication: Dayton Daily News Publish date: October 30, 2010
How was Mound Laboratory allowed to do so much harm?
I'd like to provide some first-hand information regarding the "environmental devastation" created by the Mound Laboratory during the years that my family lived on Mound Road.
In 1956, my parents bought a new home in a lovely neighborhood for their growing family. I lived there until 1966.
Beginning in 1960, the Mound released radioactive tritium into the air and contaminated the soil with plutonium-238. Our city water supply was piped up Mound hill; we played at the Adena Indian mound, spent countless hours at the Miamisburg public pool and fished in the pond.
My father worked at Presto Adhesive Paper, below Mound Lab, on Mound Avenue. He died at the age of 53 of a rare cancer multiple myeloma.
Our mother had already undergone radical mastectomy and radiation for breast cancer prior to age 50; she would later die of mesothelioma.
Our older brother died in his early sixties of bladder cancer, and my daughter had her cancerous left kidney removed while in her mid-thirties.
My family's experiences are only a small part of our neighborhood cancer history. Beginning with Mound Road, spreading back Marsha Drive and all along Meadowview Drive, one - and in most households, both - parent experienced different types of malignant disease, i.e.: multiple breast and colon cancers, parotid tumor, bladder, prostate, lung, skin, mesothelioma, brain, aplastic anemia and a child with leukemia.
I estimate that cancer occurred in 90% of the households in that neighborhood.
How did city officials allow this to happen? Where were our environmental watchdogs from the 1970s until 1989, when the Mound plant was placed on the EPA priorities list? My family and our neighbors deserve answers to those questions.
Sally Nunery Dunn
West Carrollton
A MOUND OF NUCLEAR LIES AND DEATH COMING TO TEXAS thanks to Governor Perry $$$
The Mound faclity reportedly sent 458 boxes of plant records to Los Alamos in 1993. these records were found to be contaminated with radiation and buried at Los Alamos as a health hazard. One cannot but guess what these records contained. The most significant fact being that these records were considered a health threat from uptake of radioactive particulate. This does not speak well for the historical hygiene at the facility
snip...
A bldg was administration, B was biology, C was cafeteria, D was decontamination a hot bldg. -lots of water that they tried to wash the facility with and contaminated the regional aquifer, had -to remove tons of dirt. R building was radioactive and hot. A young man got so exposed to -radiation in the T building that he died in the medical facility. The T building was far underground.
http://www.cdc.gov/niosh/ocas/pdfs/sec/mound/mound2pet.pdf
Over time, contamination leaked from these drums into the surrounding soils ...... Mound Plant OU 1 Site. Location:. Miamisburg, OH. Period of Operation: ...
http://www.frtr.gov/pdf/abstractsvol5.pdf
Air Sparging and Soil Vapor Extraction at the Mound Plant OU 1 Site, Miamisburg, Ohio 73 Costs: • The total cost for AS/SVE was $1,439,039, consisting of $116,773 for pilot testing, $221,591 for design, $398,000 for construction, $517,958 for operations, and $184,717 for sampling and analysis • As of May 2000, the overall unit cost was $420 per pound of contaminant removed Description: The Mound Plant is a government-owned and contractor-operated facility occupying a 306-acre site within the city of Miamisburg, Ohio. The OU 1 site occupies three acres on the western edge of the developed portion of the facility. The historic landfill in OU 1 was used between 1948 and 1974 for disposal of general trash and liquid wastes from Mound Plant operations. The sanitary landfill in OU 1 was constructed partially within and adjacent to the location of the historic landfill. Both disposal sites have been used for dumping, burning, moving, reworking, and burying various plant wastes. A periodic water sampling program and a Phase 1 investigation indicated that VOCS were present in the soil and groundwater at OU 1. An air sparging and soil vapor extraction (AS/SVE) system began operating at OU 1 in December 1997. The system was intended to remove chlorinated VOCs from the soil and groundwater at the site. After 2 ½ years of operation, 3,433 lbs of VOCs had been removed, and the total VOC concentrations in the unsaturated zone decreased from 618.1 to 4.54 mg/kg. If system performance is maintained, the site was projected to meet cleanup goals by December 2002. The total cost for AS/SVE at this site was $1,439,039.
http://www.frtr.gov/pdf/abstractsvol5.pdf
COMING TO TEXAS, at a nuclear dump site near somebody, thanks to the good governor perry of Texas and a lot of $$$
Thanks Gov. ...
P.S. Suggestion; I say if it must come to Texas, send all toxic nuclear waste material to Bush Ranch, Crawford, Texas USA.
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Wednesday, July 9, 2008
Ex-official: Cheney wanted climate change report altered
July 8, 2008, 1:56PM
Ex-official: Cheney wanted climate change report altered
By H. JOSEF HEBERT Associated Press
WASHINGTON — Vice President Dick Cheney's office pushed for major deletions in congressional testimony on the public health consequences of climate change, fearing the presentation by a leading health official might make it harder to avoid regulating greenhouse gases, a former EPA official maintains.
When six pages were cut from testimony on climate change and public health by the head of the Centers for Disease Control and Prevention last October, the White House insisted the changes were made because of reservations raised by White House advisers about the accuracy of the science.
But Jason K. Burnett, until last month the senior adviser on climate change to Environmental Protection Agency Administrator Stephen Johnson, says that Cheney's office was deeply involved in getting nearly half of the CDC's original draft testimony removed.
"The Council on Environmental Quality and the office of the vice president were seeking deletions to the CDC testimony (concerning) ... any discussions of the human health consequences of climate change," Burnett has told the Senate Environment and Public Works Committee. ...SNIP...END...TSS
http://www.chron.com/disp/story.mpl/hotstories/5876800.html
Tuesday, April 29, 2008
Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency
please see full text ;
http://sciencebushwhacked.blogspot.com/
TSS
Ex-official: Cheney wanted climate change report altered
By H. JOSEF HEBERT Associated Press
WASHINGTON — Vice President Dick Cheney's office pushed for major deletions in congressional testimony on the public health consequences of climate change, fearing the presentation by a leading health official might make it harder to avoid regulating greenhouse gases, a former EPA official maintains.
When six pages were cut from testimony on climate change and public health by the head of the Centers for Disease Control and Prevention last October, the White House insisted the changes were made because of reservations raised by White House advisers about the accuracy of the science.
But Jason K. Burnett, until last month the senior adviser on climate change to Environmental Protection Agency Administrator Stephen Johnson, says that Cheney's office was deeply involved in getting nearly half of the CDC's original draft testimony removed.
"The Council on Environmental Quality and the office of the vice president were seeking deletions to the CDC testimony (concerning) ... any discussions of the human health consequences of climate change," Burnett has told the Senate Environment and Public Works Committee. ...SNIP...END...TSS
http://www.chron.com/disp/story.mpl/hotstories/5876800.html
Tuesday, April 29, 2008
Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency
please see full text ;
http://sciencebushwhacked.blogspot.com/
TSS
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