<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>                                                                                           543—836845
    DEPARTMENT OF HEALTFI AND HUMAN SERVICES                Public Health SeMce
                                                            Centers for Disease Control and Prevention
                                                            National Institute for Occupational
                                                               Safety and Health
                                                             1090 Tusculum Avenue
                                                             Cincinnati OH 45226-1998
                                                              September 14, 2015
The Health Council of the Netherlands
Conmiittee on the Classification of Reproduction Toxic Substances
Attn: P.W. van Vliet, Ph.D.
P0 Box 16052
2500BBTheHague
the Netherlands
Dear Dr. van Vliet:
Thank you for the opportunity to review the draft report on Uranium and its compounds
prepared by the Subcommittee on the Classification of Reproduction Toxic Substances of
the Dutch Expert Committee on Occupational Safety (DECOS). Comments are enclosed
that were prepared by Jeri Anderson, Health Physicist and Candice Johnson,
Epidemiologist, NIOSH/Division of Surveillance, Hazard Evaluations and Field Studies
(DSHEFS), 1090 Tusculum Avenue, Cincinnati, OH 45226. Also enciosed is a reference that
was cited.
1f you have any questions regardirig the comments, please contact me at 513-533-8260
(telephone) or by Email at tb17(cdc.gov.
                                                     Sincerely yours,
                                                     Tho as Lentz, Ph.D., M.P.H.
                                                               .
                                                     Branch Chief
                                                     Document Development Branch
                                                     Education and Information Division
2 Enciosures
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<pre>    Comments on DECOS draft document on Uranium and its compounds
   By: Jeri Anderson, Health Physicist and Candice Johnson, Epidemiologist,
          NIOSHJDivision of Surveillance, Hazard Evaluations and Field
      Studies (DSHEFS), 1090 Tusculum Avenue, Cincinnati, OH 45226
SECTION & PARAGRAPH                                      COMMENT
General Corn ments                The Committee’s recommendations are appropriate.
Specific Corn rnents
Pg. 5, line 3-4                   Change second sentence to read: “Natural uranium,
                                  which is found in varying concentrations in rocks and
                                  soil, consists of three isotopes, all of which are
                                 radioactive U,234 235
                                               (      U, and 238U).
Pg. 5, line 5                     Change isotopic abundance values to 99.27% 238   U,
                                  0.72% 235
                                          U, and 0.0055% 234   U. Isotopic abundance
                                  varies slightly depending on geographic location.
Pg. 5, line 11                   Replace “ATSDR” with “U.S. Agency for Toxic
                                  Substances and Disease Registry (ATSDR)”
Pg. 5, line 14-18                Change the two sentences on these lines to read: “Since
                                 the three uranium isotopes behave the same
                                 chemically, the chemical risks from exposure to
                                 depleted and natural uranium will be similar to those
            .                    for enriched uranium. However, for enriched uranium,
                                 ionizing radiation may play a role in reproductive
                                 toxicity.”
Pg. 10, Table in section 2.1      Why did you select uranyl acetate and uranyl nitrate for
                                 the table? Although these compounds are often used in
                                 animal studies, occupational exposures to uranium
                                 usually involve the uranium oxides, uranyl fluoride,
                                 uranium hexafluoride, and uranium tetrafluoride.
                                 Adding a table heading explaining the reason these
                                 compounds were included may help, or you could add
                                 the uranium compounds common in occupational
                                 exposure.
Pg. 10, Table in section 2.1     The OSHA permissible exposure limit (PEL) is
                                 0.25 mg!m
                                        3 for insoluble uranium compounds and
                                 0.05 mg/m
                                        3 for soluble uranium compounds. The TLV
                                 is a threshold limit value recommended by the
                                 American Conference of Governmental Industrial
                                 Hygienists (ACGIH).
Pg. 11, lines 6-7                Change isotopic abundances to 99.27%, 0.72%, and
                                 0.0055% for 238U, 235 U, and 234
                                                                U, respectively.
Pg. 12, line 3                   Change “caused by the radiation of ri-particles” to
                                 “caused by ionizing radiation”
Pg. 12, line 5-6                 This statement is not necessarily accurate. Exposure to
                                 insoluble uranium compounds in an occupational      -
                                 setting, most likely via inhalation, means that the
                                 uranium will be retained for much longer periods in the
                                 lungs and less will be translocated to the bloodstream.
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<pre> Pg. 12, line 5-6 (con’t)           This resuits in much lower exposure potential (ifany)
                                   for the reprôductive organs, less potential for transfer
                                   to the embryo/fetus, and less potential for exposure of
                                   progeny via lactation.
Pg. 12, line 6-7                   This document would be improved by a brief
                                   paragraph discussing the biokinetics of uranium in the
                                   human body as well as maternal/fetal transfer. A good
                                   reference for this information is Leggett RW. Basis for
                                   the ICRP’s Age-Specific Biokinetic Model for
                                   Uranium. Health Phys 67(6): 589-6 10; 1994 (attached).
                                   For information on matemal/fetal transfer see
                                   NUREG/CR 5631 “Contribution of Matemal
                                • Radionuclide Burdens to Prenatal Radiation Doses”
                                   found here:
                                  https://www.orau.or/PTP/PTP%20Library/library/Sub
                                  jectJDosimetry/maternal.pdf
Pg. 12, line 27                    The heading “Inhalation Studies” should be deleted
                                  because only one of the cohorts in the studies cited is
                                  exposed by iiihalation. Most of the DU cohort in
                                  McDiarmid’s studies are exposed by absorption of
                                  uranium from depleted uranium shrapnel embedded in
                                  tissue/muscle.
Pg. 12, lines 28-34 and Pg. 13,   The primary exposure for uranium miners is radon and
lines 18-20                       radon decay products. The uranium exposure is
                                  relatively insignificant. This should be mentioned
                                  either here or in the first paragraph of the conclusion
               ‘
                                  onpg.19.
Pg. 14, line 13                   The citation appears to be incorrect. Should it refer to
                                  reference #21?
Pg. 15, line 18                   Insert “no observed adverse effect level” before
                                  “NOAEL” and enciose “NOAEL” in parentheses.
Pg. 15, lines 20-21               It is unclear what is meant by the phrase “28 days
                                  range finding study.” Please explain, reword, or delete
                                  the phrase.
Pg. 15, line 32                   Insert “lowest observed adverse effect level” before
                                  “LOAEL” and enclose “LOAEL” in parentheses.
Pg. 19, Section 2.4.1             It should also be pointed out here that the exposure
                                  pathway for the Gulf War Veterans is unique
                                  (embedded fragments) and not the normal pathway for
                                  occupational (inhalation pathway) or environmental
                                  (ingestion pathway) exposure. Also, based on the
                                  measured urine uranium concentrations, their
                                  exposures are lower than those found in historical
                                  cohorts at uranium processing facilities.
Pg. 20, lines 9-13 and 27-28      The language in these statements is confusing and
                                  seemingly contradictory. Is the Committee
                                  recommending that uranium be classified as Category
                                  2? Why does it then say that the Committee
                                  recommends not to classify uranium due to lack of
                                  data?
                                        2
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<pre></pre>

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<pre>E-mail
Datum:                 woensdag 19 augustus 2015
Aan:                   GR_draftOSH@gr.nl
Subject:               Commentaar
Geachte auteur(s),
Dank voor het openstellen van uw draftdocument over ‘Uranium and its compounds’ voor
commentaar. Hieronder per pagina commentaar en suggesties. Het commentaar kan
inhoudelijk en hier en daar politiek van aard zijn.
Page 3, line 3-4:                    Remark: to prevent contradiction with line 14-16, one could
                                     emphasize the 'amount' of radioactivity.
                                     Suggestion: "Uranium komt in de natuur voor als mengsel van
                                     verschillende uraniumisotopen (U-234, U-235 en U-238) die elk in
                                     meer of mindere mate radioactief zijn."
Page 3, line 12:                     ATSDR stands for ...
Page 3, line 22-27:                  Remark: To be clear; the Dutch commercial nuclear industry doesn’t
                                     produce HEU for use in navy ships nor weapons.
                                     Neither will the DU, produced as a by-product of LEU, be used for
                                     armour-piercing ammunition for the Dutch military.
                                     It might be useful to perform an analysis of Dutch industries using
                                     uranium or uranium compunds in its facilities instead of using USA
                                     (nuclear) industrial examples.
Page 3, line 22-25:                  Remark: The translation to Dutch is incorrect. Suggestion:
                                     “helikopters en vliegtuigen, als afschermingsmateriaal en in
                                     Röntgenapparatuur.”
Verder, het ATSDR-rapport “Toxicological profile for Uranium” uit februari 2013 concludeert
op pagina 6 dat “We do not know whether uranium can harm an unborn child. No
scientifically strong human study that has shown birth defects due to uranium exposure has
been identified.” Hoe kan de Gezondheidsraad, op basis van dezelfde informatie als het
ATSDR, tot een andere conclusie komen, namelijk een Cat 2 classificering? Waarschijnlijk
lees ik iets over het hoofd en kunt u mij hierop wijzen.
Met vriendelijke groet,
T.P. (Tjerk) Kuipers
Senior adviseur straling
.........................................................................
Cluster Stralingshygiëne
Coordinatiecentrum Expertise Arbeidsomstandigheden en Gezondheid (CEAG)
Defensie Gezondheidszorg Organisatie
Commando DienstenCentra
Ministerie van Defensie
Postbus 185 l 3940 AD l Doorn
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