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Please distribute widely:

The Federal Register published my rulemaking petition for recognition of the developmental and reproductive toxicity of heavy metals (70 FR 34699.)

Please send a comment before August 29th to SECY@nrc.gov with a subject line such as:

comments on PRM-20-26 toxicity petition
Be sure to include "PRM-20-26" in the subject line. You should get an email reply confirming receipt of your comments immediately. If you do not, please let me know.

I recommend that you use your own words, but please include the following points: (continued)

  • Current regulations ignore the developmental and reproductive toxicity of heavy metal radionuclides, and are at present designed only to prevent kidney failure.

  • The reproductive toxicology profile for uranium combustion product inhalation in humans is currently unknown with any accuracy beyond 14 years (i.e., since the February 1991 exposures) and has shown an increasing and accelerating tendency, consistent with the fact that uranium accumulates in testes damaging sperm production cells and increasing chromosome damage over time.

  • It is completely unethical and immoral to allow any release of a known reproductive toxin without a fully established toxicology profile. Doing so is reckless and negligent; to willfully allow such releases is potentially a crime.

  • Regulators should attempt to extrapolate the existing known toxicology profile of heavy metal radionuclides and assume the worst case within the projections' 95% confidence intervals, and in an abundance of caution allow at least a two order-of-magnitude margin of error for limiting the increase in congenital malformations in children of the exposed to 5% after 30 years.

Thank you for the time and effort to help protect against birth defects. Excerpts from peer-reviewed medical literature in support of this petition follow.

Sincerely,
James Salsman

From the peer-reviewed medical literature:

"Overall, the risk of any malformation among pregnancies reported by men was 50% higher in Gulf War Veterans (GWV) compared with Non-GWVs"
-- Doyle et al. Int. J. Epidemiol..2004; 33: 74-86.

"Infants conceived postwar to male GWVs had significantly higher prevalence of tricuspid valve insufficicieny (relative risk [RR], 2.7; 95% confidence interval [CI], 1.1-6.6; p = 0.039) and aortic valve stenosis (RR, 6.0; 95% CI, 1.2-31.0; p = 0.026) compared to infants conceived postwar to nondeployed veteran males. Among infants of male GWVs, aortic valve stenosis (RR, 163; 95% CI, 0.09-294; p = 0.011) and renal agenesis or hypoplasia (RR, 16.3; 95% CI, 0.09-294; p = 0.011) were significantly higher among infants conceived postwar than prewar."
-- Birth Defects Res A Clin Mol Teratol. 2003 Apr;67(4):246-60.

Here are some quotes with their full citations from "A review of the effects of uranium and depleted uranium exposure on reproduction and fetal development," in Toxicology and Industrial Health, vol. 17, pp. 180-191 (2001), which is temporarily at:
http://www.bovik.org/du/reproduction-review-2001.pdf

"In rats, there is strong evidence of DU accumulation in tissues including testes, bone, kidneys, and brain." Pellmar, T.C., Fuciarelli, A.F., Ejnik, J.W., Hamilton, M., Hogan, J., Strocko, S., Edmond, C., Mottaz, H.M. and Landauer, M.R. "Distribution of uranium in rats implanted with depleted uranium pellets," Toxicol Sci, vol. 49, pp. 29-39 (1999.)

"Degenerative changes in the testes resulting in aspermia in the testes and epididymis ... apparently a result of uranyl nitrate" Maynard, E.A., Downs, W.L. and Hodge, H.C., "Oral toxicity of uranium compounds," in Voegtlin, C. and Hodge, H.C., editors, Pharmacology and Toxicology of Uranium, Volume 3 (New York: McGraw-Hill, 1953), pp. 1221-1369.

"uranium exposure causes morphologic changes in the rat testes possibly as the result of a uranium-induced autoimmune response.... Average testes weight was significantly (P0.05) decreased in rats exposed to uranyl nitrate.... Titers of testicular autoantibodies were described as fairly high for rats with chronic exposure to uranium and the authors relate this finding to the possibility that the observed testicular changes are an autoimmune response to protein confirmation changes as a result of uranium-protein interactions. Four other references are cited ... as evidence of an interaction between uranium and the testes or thyroid but are not reviewed here." Malenchenko, A.F., Barkun, N.A. and Guseva, G.F., "Effect of uranium on the induction and course of experimental autoimmune orchitis and thyroiditis," J Hyg Epidemiol Microbiol Immunol, vol. 22, pp. 268-277 (1978.)

"The number of female mice impregnated successfully was significantly reduced at all levels of uranium exposure as compared with negative controls." Hu, Q. and Zhu, S., "Induction of chromosomal aberrations in male mouse germ cells by uranyl fluoride containing enriched uranium," Mutat Res, vol. 244, pp. 209-214 (1990.)

Testicular injection with ... uranyl fluoride ... resulted in a dose-dependent increase in chromosomal aberrations (i.e., DNA breakage, SCEs) in spermatogonia, primary spermatocytes, and mature sperm of adult mice." Zhu, S.P., Hu, Q.Y. and Lun, M.Y., "Studies on reproductive toxicity induced by enriched uranium," Zhonghua Yu Fang Yi Xue Za Zhi, vol. 28, pp. 219-222 (1994.)

"existing data indicate that implanted DU translocates to the rodent testes and ovary, the placenta, and fetus.... DU has been shown to be genotoxic...." Benson, K.A., Evaluation of the health risks of embedded depleted uranium (DU) shrapnel on pregnancy and offspring development, Annual Report No. 19981118065 (October 1998.) That quote also cites Pellmar, et al., as above, and A. Miller et al., from the U.S. Armed Forces Radiobiology Research Institute, whose work can be found on MEDLINE and here:
http://www.bovik.org/du/Miller-DNA-damage.pdf

For more information please see:
http://www.bovik.org/du/chromosome-abberations.pdf
http://www.bovik.org/du/devtox-mice.pdf
http://www.bovik.org/du/inhalation-est.pdf
http://www.bovik.org/du/5_Durakovic.pdf
http://www.bovik.org/du/4_Durakovic.pdf

Originally posted to js7a on Wed Jun 15, 2005 at 09:07 AM PDT.

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Comment Preferences

  •  Forgot to ask (none)
    I know there are a lot of important things going on, but please recommend this, too.

    No tips though thanks; I don't have time or energy for the hidden comments.

  •  CA state regulators (none)
    I'm curious: is there any comparable push with California state regulators?
  •  Sorry, but I haven't got a clue, (none)
    and statements such as this
    "4. Regulators should attempt to extrapolate the existing known toxicology profile of heavy metal radionuclides and assume the worst case within the projections' 95% confidence intervals, and in an abundance of caution allow at least a two order-of-magnitude margin of error for limiting the increase in congenital malformations in children of the exposed to 5% after 30 years."

    really cause me to pause. An article today regarding TSA and money spent versus gains in security highlight the waste that can occur making such assumptions.

    Democracy is the worst form of government except for all those others that have been tried. -Winston Churchill

    by roysol on Wed Jun 15, 2005 at 09:52:20 AM PDT

    •  I'm not sure what you are getting at. (none)
      What do you think the costs of limiting birth defects in this manner would be?
      •  As I said in my title (none)
        I haven't got a clue. You have provided page after page of clincal data that only a reasearcher could love. Surely you don't expect us average lay people to understand the subject matter. It seems reasonable you are correct that more releases of toxic materials equals more health problems. My question to you is the scale of the problem.

        "What do you think the costs of limiting birth defects in this manner would be?"

        This is exactly my point. I don't know, and you do not say. And what would be the cost per reduction of a negative outcome? If your proposal had a zero cost, I assume it would already be done.

        Perhaps we get a better return focusing on convincing mothers to quit drinking and smoking while they are pregnant, for example.

        I would not oppose your petition based on my poor knowledge of the subject, neither can I blindly support it as you request.

        Democracy is the worst form of government except for all those others that have been tried. -Winston Churchill

        by roysol on Mon Jun 20, 2005 at 10:23:06 AM PDT

        [ Parent ]

  •  My letter (none)
    With our soldiers spending 1 year in a landscape littered with  heavy metal radionuclides we should err on the side of caution and make efforts to limit their exposure. Surely a "culture of life" who goes to big lengths to protect the unborn  would put the protection of our Armed Forces offspring from birth deffects as one of it's top priorities!

        * Current regulations ignore ...

        * The reproductive toxicology profile for...

        * It is completely unethical...

        * Regulators should ....

    Sincerely,

    Law

    When morality is only about sex, no aspect of war - even the killing of entire families - can arouse criticism, much less condemnation.

    by lawnorder on Mon Jun 27, 2005 at 09:33:08 PM PDT

  •  Thanks for this petition! (none)
    DU is one of my pet peeves too!

    When morality is only about sex, no aspect of war - even the killing of entire families - can arouse criticism, much less condemnation.

    by lawnorder on Mon Jun 27, 2005 at 09:34:00 PM PDT

  •  If you have strong stomach (none)
    see pictures of American babies affected

    http://www.life.com/Life/essay/gulfwar/gulf08.html

    Cedrick's handicaps have left his parents, Steve and Bianca, terrified of having more children.

    Cedrick suffers, like Casey Minns, from Goldenhar's syndrome. The left half of his face is shrunken, with a missing ear and a blind eye. His mother, Bianca, says that when a prenatal exam showed the defects, "everything we'd hoped for just crashed. What had Cedrick done to deserve this?"

    Steve Miller, a former Army medic, thinks chemicals damaged his sperm. He believes statistical evidence is at hand. "With Goldenhar's," he says, "we have clustering."

    Clustering is the term epidemiologists use when an ailment strikes one group of people more than others--and the phenomenon can be a key indicator that something more than chance is causing birth defects. The Association of Birth Defect Children says it has found the first cluster of defects in the offspring of U.S. Gulf veterans: 10 babies with severe Goldenhar's syndrome, a condition that usually strikes one in 26,000, according to ABDC executive director Betty Mekdeci. (Another case has surfaced in Britain, where 600 vets complain of Gulf-related illness.) The ABDC, which has gathered data on 163 ailing Gulf War babies so far, is tracking four more possible clusters--of victims of hypoplastic left heart syndrome, of atrial-septal heart defect, of microcephaly and of immune-system deficiencies. Significantly, not one of the parents in the ABDC survey has a family history of these types of birth defects. Or as Mekdeci puts it, "There have been no relatives with funny ears."

    The difficulty in proving conclusively whether clusters are occurring is that no one--not Mekdeci, not the Pentagon--knows how many babies have been born to Gulf vets. The Defense Department's own survey of 40,000 birth outcomes, initial results of which are due in late October, is the largest study yet, but far from complete since it relies on data only from military hospitals. The Pentagon's Dr. Joseph says the forthcoming report will include "by far the best and most comprehensive information available." Maybe it will, but many still question whether Defense Department scientists are really seeking the hard answers. Earlier this year Dr. Joseph told LIFE that, although trained as a pediatrician, he was entirely unfamiliar with "Goldhavers or Gold Heart--whatever." It's precisely that kind of response that enrages veterans with afflicted babies.

    Along with the ABDC and Defense Department surveys, more than 30 other studies of Gulf vets and their children are under way. One that is no longer ongoing, by the Senate Banking Committee, folded last year when committee chair Don Riegle retired. Of the 400 sick vets who had already answered committee inquiries, a startling 65 percent reported birth defects or immune-system problems in children conceived after the war.

    When morality is only about sex, no aspect of war - even the killing of entire families - can arouse criticism, much less condemnation.

    by lawnorder on Mon Jun 27, 2005 at 10:38:58 PM PDT

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