1 15 2 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 088 Folder The folder containing the original item. 2218 Series The series number of the original item. Series IV Subseries II Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Silbergeld, Ellen K. Title A name given to the resource Letter: from Ellen K. Silbergeld to Robert Huffaker, January 25, 1983 Subject The topic of the resource BSOB dioxin analytical studies health monitoring https://www.nal.usda.gov/exhibits/speccoll/files/original/d3ad60c02d08d45495a8b3d816e69edb.pdf 1c4c57e8cebd8897224e5f04911b2618 PDF Text Text Rom D Number 0229 Author Silbergeld, Ellen K. ° Corporate Author Rnnnrt/Artlnln Tltta Typescript: Affidavit of Ellen K. Silbergeld, November M 14, [1984] Journal/Book Title Year Month/Day Color Number of Images D 5 Descriptor) Notes Thursday, September 20, 2001 Page 2290 of 2293 �AFFIDAVIT OF ELLEN K. SILBERGELD Comes now Dr. Ellen K. Silbergeld who states as follows under penalty of perjury: 1. In this Agent Orange litigation, I have previously had the following involvement. I have prepared and reviewed an expert summary which was filed with the Court concerning the substance of my proposed testimony and certain supplements thereto. a deposition in New York City on March 18 and 19, 1984. I have given I have also prepared a 13 page affidavit which was an exhibit to Opt-Out Plaintiffs' Opposition to Defendants' Motion to Dismiss, or in the Alteri native, for Summary Judgment. I wish to incorporate those statements, testimony and affidavit by reference. The matters set forth there- in are all true and correct to the best of my personal knowledge. 2. I understand that the primary focus of the government's motion to dismiss is in the area of reproductive toxicity. This is my particular field of specialization as a scientist, and I have devoted substantial professional time and effort in the area of the reproductive toxicity of polycyclic halogenated hydrocarbons, of which dioxin is a member. 3. Epidemiological/statistical evidence is related to the understanding of facts in the case of an individual to the extent that it can be demonstrated that the individual shares the characteristics (and exposures) of the epidemiological group (cohort) for which the statistical evidence was derived. This is the case in all issues of medicine and science, and hence all such issues share this common characteristic. �4. The criteria first enunciated by Bradford Hill for determining the acceptability of epidemiological data are (1) replication, (2) strength of association, (3) temporal relationship, (4) specificity, and (5) biological plausibility. Using these criteria as guides, it can be posited, based upon the data known and available to date, that Agent Orange causes the diseases and effects alleged by plaintiffs, particularly with respect to birth defects. 5. In the area of replicability, there are as yet relative- ly few studies. However, it is worth noting that data from Seveso (Bisanti, in press) are consistent with the CDC 1984 study and with the Ranch Hand study. All three studies report increases in certain birth defects, notably minor malformations (including hemangiomas)-, spina bifida, and cleft palate. The Australian study is not apparent- ly consistent with these findings; however, there was no attempt by the Australian study to determine likelihood or intensity of dose, so that it is very likely (based upon information from the Royal Commission) that unexposed veterans were included in the exposed group. This would render any conclusions reached by the Donovon study suspect and weak. There also appears to be an excess of neo- natal deaths reported in both the Ranch Hand, CDC, and Serveso data. 6. In the area of strength of association, there is not presently a great deal of reliable information due to the absence of quantifiable exposure data. In the occupational studies, there is insufficient evidence as to dose, incomplete collection of subjects (Dow study), or insufficient numbers (Czech study; Seveso; Nitro -2- �study). Strength of association is usually demonstrated as a func- tion of dose response relationships. There is some qualitative evi- dence for dose response in the CDC study, but the absence of quantifiable exposure data is a definite obstacle here. 7. In the area of temporal relationship, there is again little data, but, what data there is from the Ranch Hand study, from the CDC study and from some of the Seveso data are consistent with temporal logic. The Ranch Hand II study looked at some veterans before and after Southeast Asian service. In this group, it could be seen that there was an increase in the incidence of several malemediated reproductive effects, including anomalies. The Seveso study has also reported an increase in hemangiomas after the exploi sion, an increase which has now been reversed after the passage of additional time. (Bisanti). The CDC study remarked, but did not de- tial, that,in exposed veterans' families, there was a much higher incidence of more than one child with a birth defect. 8. In the area of specificity, there exists some of the strongest reproductive toxicity data, although it has not been appreciated. No study has found that Agent Orange or dioxin exposure in other circumstances increases the rate of all birth defects or all types of reproductive toxicity. Instead, the positive studies (noted above) have found increases in only a few types of defects. This is strongly suggestive of specificity and of a specific toxic agent. 9. In the area of biological plausibility, there is sub- stantial evidence for male-mediated birth defects, miscarriages, toxic -3- �exposures, and other unfavorable outcomes expressed in children. Dr. F. Stanley's statement for the Austrailian Royal Commission discusses such hypotheses in considerable detail. These include (1) gametotoxic effects, (2) genetic effects, and (3) secretion of dioxin in seminal fluid. While this latter possibility is dismissed by Dr. Stein in her affidavit, it is known that lead can be secreted in seminal fluid, and Robaire's group at McGill is studying the effects of seminal fluid cytostatic drugs on pregnancy outcome. One of the positive findings of the CDC study is of particular importance here: the increase in childhood cancer in children of the . exposed veterans. Male exposures (occupational) have been demon-, strated to be associated with increases in childhood cancers (Kantor, and others). To my knowledge, no other study has looked for child- hood cancer specifically, although in Ranch Hand II the causes of neonatal deaths are not described, the similarity between it and the CDC study in this regard is striking. 10. Thus, looking purely at epidemiologic criteria, it can be said that the two major United States studies of Vietnam veterans document and add to the growing body of knowledge that dioxin exposure can and did cause adverse reproductive outcomes. It is true that there are gaps in our knowledge, but those gaps do not present obstacles to the formulation of reasonably-based scientific opinions on causation. The major gaps are in the areas of strength of asso- ciation and temporal relationship. below. -4- The reasons for this, I address �11. As I noted above, there are frustrating gaps in our scientific knowledge of the reproductive toxicity of dioxin. Those gaps are due to the failure to determine, monitor and record for posterity the amount of exposure of individual veterans at the time of exposure. The gaps are also due to the failure to test the exposed servicemen for the presence of dioxin or its effects in their bodies at and/or shortly after the time of their exposure, the failure to keep meaningful medical records of post exposure symptoms, signs, conditions, illnesses and diseases, and the failure to test the Agent Orange product in animals and other lower forms of life prior to spraying. 12. Those failures to obtain and record pertinent data - doomed scientific analysis to uncertainty and inconclusiveness in ' large part. It is only by testing epidemiologically for specific outcomes based upon refined exposure data that cause and effect relationships can be elucidated clearly. The absence of such data here, however, does not prevent the formulation of reliable, validly-based scientific opinion as to causation ; it only makes the testing of such hypotheses and the interpretation of available data more difficult. 13. Nonetheless, the fact remains that there is reasonable scientific data available upon which to formulate a valid opinion that dioxin was the cause of adverse reproductive outcomes in children of servicemen exposed to it in Vietnam. Ellen K. Silbergeld* ELLEN K. SILBERGELD *Dr. Silbergeld is presently out of the country as this typed in final form (11/14). It was read to her in its the evening of 11/13 and she approved it. The original to her for signature and delivery to the Court upon her this country. _5_ affidavit is entirety on will be sent return to � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young. For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 090 Folder The folder containing the original item. 2290 Series The series number of the original item. Series IV Subseries II Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Silbergeld, Ellen K. Title A name given to the resource Typescript: Affidavit of Ellen K. Silbergeld, November 14, [1984] Subject The topic of the resource BSOB dioxin congenital birth defects health studies