Item D Number °4998 D Not Scanned

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RBDOrt/ArtiClO TitlO VA Advisory Committee on Environmental Hazards,1985

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DBSCripton NOtOS Assorted minutes, reports, correspondence, and lists relatedto the VA Advisory Committee on Environmental Hazards.Alvin L. Young filed these materials under the label "VAAdvisory Committee on Environmental Hazards."

Friday, February 22, 2002 Page 4998 of 5115

VETERANS'ADVISORY COMMITTEE ONENVIRONMENTAL HAZARDSSCIENTIFIC COUNCIL

JUNE 24, 1985

The Scientific Council of the Veterans' Advisory Committee onEnvironmental Hazards convened at 9:10 am. Following briefintroductory remarks by Dr. Kurland, the Council received a briefingfrom Dr. Lathrop on the status of the Ranch Hand Study. Dr. Lathropreported on the findings of the first morbidity report and on thefirst mortality report. Enlisted men in both the Ranch Hand groupand the controls have a higher mortality than the officers but themortality rate was still lower than that of the general population.He noted the limitations of the study due particularly to the sizeof the study population. He reported that the study has thus farrevealed no herbicide causality for any particular disease or healthproblem. The mortality study also revealed no unusual patterns orrates of death. One finding of interest was the absence of anydiagnosis of chloracne amoqg the Ranch Hand population. Nosignificant differences in the rate of severe and moderatemalformations among offspring of the Ranch Hand group and thecontrols have been noted. Mild malformations (skin blemishes etc.)were more frequent among the Ranch Hand group but this may reflectgreater sensitivity of the Ranch Hand parents in reporting &uchmalformations. Further studies are underway. The Council expressedno criticism of the study's results or of the study's methodology.

Dr. Yanders provided a thorough and balanced overview of severalstudies relating to soft tissue sarcomas and their possibleassociation with exposure to dioxin.

Dr, Colton reported on two mortality studies which have beenreported involving Vietnam veterans. A study of the mortality ofVietnam veterans from Massachusetts revealed a higher than expectedincidence of death due to soft tissue sarcoma among veterans whoserved in Vietnam. There was no attempt to correlate the findingswith the amount of exposure to Agent Orange a veteran may have hadin Vietnam. The authors of the Massachusetts study have stated thelimitations of their study and have not overstated their findings.

2.

Dr. Colton noted that the study legitimately raises some questionsconcerning the association of soft tissue sarcoma with service inVietnam. Regarding a similar but negative study conducted in NewYork state, he noted that the study may have been conducted too soonto reveal any conditions which may have a long latency period.A study from New Zealand was also reviewed and it revealed nosignificant increase in soft tissue sarcoma among the exposed group.

The conclusion of the Council following discussion was thatthere is no pursuasive evidence that soft tissue sarcoma occurs withany greater frequency among individuals exposed to dioxin than amongthose not so exposed. The Council believed that the jury is stillout on this issue and that no firm conclusions can be made at thistime.

The general consensus, therefore, was that the VeteransAdministration's approach as expressed in the proposed regulationsis in concert with the current scientific understanding about thehealth effects of exposure to dioxin.

Mr. Seymour jablon reported to the Council the results of arecently completed study of individuals who participated in a seriesof atomic weapons tests. The study revealed no consistent evidenceof increased deaths from cancer or other diseases for the veteransoverall. The study did reaffirm the observation of an excess ofleukemia among one group of veterans and found a slight increase inthe number of prostate cancers among another group. Mr. Jablonreported that the investigators concluded that the lack ofconsistent evidence of increased cancer incidence could have twopossible explanations: the observed incidence of leukemia among theSmoky participants is simply a "chance aberration" or the actualradiation exposure of these men was several times the dose recordedat the time.

There was an extensive discussion of the recently releasedradioepidemiological tables. There was general agreement that thetables reflect the best available information and represent valid

3.

science. Dr. Theissen had presented to the Council therecommendations of the Science Council of the Committee on Inter-agency Radiation Research and Policy Coordination and noted thatthere were some uncertainties associated with the Tables. TheCouncil agreed with this analysis yet believed that the Tables mayhave some applicability to the VA's compensation system. TheCouncil recommended, therefore, that following a determination ofexposure and the presence of a radiogenic cancer occurring withinthe appropriate latency period the tables be used as a startingpoint in considering claims but should not be the finaldeterminative in granting or denying service connection. Theapproach recommended by the Council is that the tables be used todetermine an estimate and a range of probability that a given cancerwas caused by a given exposure to radiation reflecting theuncertainties in the doses and the table values. In addition to theTables, other factors should be considered such as the individual'sfamily history, his/her exposure to other known carcinogens, and theindividual's life-style and occupational history. Expressing theprobability of causation as a range rather than as a specific numberwill convey the basic uncertainty associated with the Tables andwill tend to diminish the likelihood of total reliance upon theTables themselves.

There was also discussion of possible threshold values ofprobability of causation or dose levels below which it is highlyunlikely that the radiation exposure was causative but no formalrecommendation was made.

Respectfully submitted,

Frederic L. ConwExecutive Secretary

Veterans' Advisory Committee onEnvironmental Hazards

June 25, 1985

A member of the audience questioned the way in which the regulationscharacterize the relationship between exposure and diseases. Heproposed that the VA articulate a standard for such matters. TheCommittee referred this comment to the Agency.

The Committee reviewed the various written comments that have beenreceived by the Agency on the proposed regulations governing theadjudication of claims for compensation based upon exposure todioxin or ionizing radiation. The Committee observed that most ofthe comments related to policy matters to De addressed by theAgency.

Dr. Taylor provided an overview of chloracne. He described methodsand routes of exposure to chloracnegens, the various types ofchloracnegens, the clinical aspects of chloracne and the diagnosticcriteria for chloracne.

Following Dr. Taylor's presentation, the Committee focused on theproposed regulations governing the adjudication of claims fordisability compensation based upon exposure to dioxin. Some concernwas expressed about the proposed three month presumptive period forchloracne, the principal concern being whether a veteran's servicemedical records would accurately reflect the nature of the skincondition a veteran may have received treatment for while inVietnam, e.g. misdiagnosing a case of chloracne as tropicaldermatitis. Dr. Taylor expressed the opinion that chloracne usuallymanifests itself shortly after exposure, generally within a matterof days, and that the three months presumption appeared to be quiteadequate. Dr. Lathrop noted that in the Ranch Hand study, there hadbeen no case of chloracne found, neither by current manifestation,biopsy examination, nor by history. The absence of chloracne amongthis group of individuals who are believed to have had high exposureto Agent Orange could not be explained and no conclusions could bedrawn from this.

2.

The Committee concluded its review of the "dioxin rule" byobserving it had no serious objections to the proposed rule andgenerally endorsed the principles of the regulation. It wassuggested that the Agency emphasize to its adjudicators that thediagnosis of chloracne need not have been made within the threemonth period in order for service connection to be established.

Regarding the proposed regulations governing claims based uponexposure to ionizing radiation, there was some discussion about theproposed latency period of more than two years but lea's than 30years for leukemia and bone cancers and more than ten years for allother cancers. The Committee recommended that the minimum latencyperiod for leukemias and bone cancers be reduced to one year and forall other radiogenic cancers to five years. The Committee observedthat the open-ended latency period for other cancers is consistentwith information currently available.

With respect to the list of radiogenic diseases, the Committeerecommended that the Agency adopt the list of cancers used by the AdHoc Working group in the radioepidemiological tables developed bythem. This would result in the addition of cancer of the esophagus,stomach cancer, colon cancer, cancer of the pancreas, cancer of thekidney and urinary bladder, and salivary gland cancer to the list ofradiogenic diseases. The Committee had no objection to theinclusion of skin cancer. It's absence from the list used by the AdHoc Working Group was due to the fact that skin cancer is notobserved at low doses and not to any suggestion that it is anon-radiogenic disease.

In the regulation pertaining to the evaluation of studies, therewas concern expressed about the factor regarding whether a study'sfindings are statistically significant. It was noted that a studymay present statistically significant findings and yet still not bea valid study. When alternative language such as "statistically andepidemiologically valid" was suggested for this regulation, it wasnoted that the language to which the objection was raised was drawndirectly from the statute. On this basis it was questioned whether

3.

the Agency could substitute any other language. Similar languagewas found in the definition of "sound scientific evidence."Accordingly, the Committee recommended that the language"statistically and epidemiologically valid" be substituted for"statistically significant" in that regulation.

The Committee had no objection to the exclusion ofpolycythemia vera from the radiation regulation where thatregulation pertains to granting service connection on a presumptivebasis .

The Committe raised no objections to the procedures set forth inthe proposed regulations for handling claims. The Committeeendorsed the proposed radiation regulations as a whole with theexceptions noted.

Finally, the Committee asked to oe kept informed with respect towhatever additional comments the Agency may receive on its proposedregulations. It also asked that it be provided an opportunity toreview whatever changes are made to the proposed regulations inresponse to the comments reviewed. The Agency agreed to try toaccommodate the Committee to the extent that time permits.

Respectfully submitted,

//l/duu^ /, \,<T

Frederic L. ConwayExecutive Secretary

RIPOUT OF CONTACTNOTE: This form must befitted out in Ink or on typewriter,as It becomes a permanent record in veterans' folders.

VA OFFICE

DM&S (10X21)

IDENTIFICATION NOJ. (C, XC, SS, XSS,V, K. etc.)

LAST NAME—FIRST NAME —MIDDLE NAME OF VETERAN (Type or print) DATE OF CONTACT

9/15/86

ADDRESS

Lt. Col. Alvin L. Young, Ph.D., Senior Policy Analyst^ .and -TadaajolQ^y. Policy-

TELEPHONE NO. OF VETERAN

395-3125Pf RSON CONTACTED

Layne A_._ Drash, Chief r Administratiye Support Staf£,._ AOPOADDRESS OF PERSON CONTACTED

TYPE OF CONTACT (Chick)

L9 PERSONAL I-J TELEPHONE

TELEPHONE NO. Of PERSON CONTACTED

653-5047BRIEF STATEMENT OF INFORMATION REQUESTED AND GIVEN

I was contacted by Lt. Col. Alvin L. Young on this date regarding the statusof the draft monograph Human Exposure to Herbicides prepared by Dr. Terry Lavyin 1982-83 under contract with the VA. Dr. Young stated that he has calledDr. Shepard six times in the very recent past concerning this matter, but thatDr. Shepard did not return any of his calls even though he has made it clearon several occasions that he (i.e., or. Young) considered the excessive delayin getting this work published a serious matter. Dr. Young further statedthat he had personally initiated this effort in 1982, but that Dr. Shepard, todate, has refused to proceed with its publication. He also noted thatDr. Lavy has repeatedly called Dr. Shepard to request an explanation for thedelay, but again, Dr. Shepard did not return those calls. Dr. Young notedthat Dr. Lavy has advised him that Dr. Shepard has also not responded to hiscorrespondence inquiries concerning this matter.

In conclusion, Dr. Young said that he is going to prepare a letter to Dr, EarlBrown, Jr. (10X) concerning this matter. He specifically asked me to preparethis Report of Contact stressing that he wishes it to be brought immediatelyto the attention of responsible Agency staff.

cc: *U.Col. Alvin L. Young

DIVISION OR SECTIONAdministrative Support StaffAOPO, 10X21 Chief, Administrative Support Staff

VA FORM » <,JUL. t f»77 • *

EXISTING STOCKS OF VA fO«M II?,JUL 1 974 WILL RE USED-

EXECUTIVE OFFICE OF THE PRESIDENTOFFICE OF SCIENCE AND TECHNOLOGY POLICY

WASHINGTON, D.C. 20506

September 19, 1986

Dear Dr. Brown:

The events of the past week prompted me to write to you. LastFriday, 5 September 1986, the Journal of the American MedicalAssociation carried an article that received wide publicity—"Agricultural Herbicide use and Risk of Lymphoma and SoftTissue Sarcoma". As you and I know, a case-control study,although significant, seldom places into perspective the rarityto which a disease like non-Hodgkin's Lymphoma occurs and theliklihood that some one's handling of 2,4-D would place themat a real risk of developing the disease.

The public, and more especially the medical community, has sofew sources of information to which they can turn for factualmaterial. The VA has published the literature reviews on thephenoxy herbicides and dioxin but in 1982 the VA initiated aspecial program to develop monographs on special topics. Iplayed a role in the selection and initiation of both ofthose programs. Of the three monographs the VA contracted forand closely followed development of, only two have been published(Birth Defects and Cacodylic Acid). The first monograph submittedto the VA and yet remains to be published is the Monograph on,of all subjects, Human Exposure to the Phenoxy Herbicides. Thatmonograph was twice edited by specialists and has apparentlylayed dormant in the Agent Orange Projects Office for many, manymonths. My frustration is that this monograph had a purpose—toinform your VA physicians of human exposure to such herbicidesas 2,4-D. The author has written and called me and Dr. Shepardmany times over the last couple of years and yet no resolutionhas occurred.

The second event this past week involved the announcement by theNew Jersey Agent Orange Commission of dioxin in the blood andadipose tissue of Vietnam veterans. More than four years ago,the VA took the initiative and lead the scientific communityinto pursuing this issue. The VA published a preliminary studyand followed it up with the design of a major survey of dioxinin human adipose tissue. The program, after the protocol wasdeveloped, simply "wilted on the vine". I have now been informedthat although it is now underway, we can expect no results untilmid-1987.

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The VA has so much to be proud of in its response to the needsof the Vietnam Veteran. The Agency organized a credibleresponse to the concerns of Veterans over Agent Orange, andin concert with the Agent Orange Working Group, committed itsresources to resolving this difficult issue. At a time whenwe are finally finding answers and can begin to see an end insight, we must not weaken the resolve to complete the task. Iurge your continued support to see that the monograph effortis completed, the dioxin studies done, and the health studiespublished.

In my role as an advisor to the Executive Office of the Presidenton this issue of Agent Orange, I can assure you that we areinterested in your program and would be pleased to assist youas appropriate.

Sincerely yours

Alvin L. Young, Ph.D.Senior Policy Analyst

for Life Sciences

Dr. D. Earl Brown, Jr.ADCMD, Programs, Planning

and Policy Development (10X)Veterans Administration810 Vermont Avenue, N.W.Washington, D.C. 20420

Office of General Counsel Washington D.C. 20420

VeteransAdministration

WAR 0 6 198B In Reply Refer To: (02C)

Alvin L. Young, Lt. Col., Ph.D.Senior Policy Analystfor Life SciencesExecutive Office of the PresidentWashington, D,,C. 20506

Dear

Public Law 98-542 called for the establishment of a VeteransAdvisory Committee on Environmental Hazards. The two areasthat are of specific concern to the Committee are the healtheffects of exposure to dioxin and to ionizing radiation as aresult of participation in the atomic weapons program or ofservice with the occupation forces of Hiroshima and Nagasaki,Japan. The first meeting of the Committee is scheduled forApril 22 and 23, 1985, at the Veterans Administration CentralOffice, 810 Vermont Avenue, N.W., Washington. For yourinformation, I am enclosing copies of the Committee's charterand membership roster.

I thought it would be helpful at the outset for the Committeeto receive a briefing on the use of herbicides in Vietnam andsome of the major iniatives undertaken by the Federalgovernment in response to concerns expressed by Vietnamveterans. I would appreciate it very much if you would bewilling to address the Committee on the herbicide issue onMonday afternoon, April 22, 1985. If another time on eitherof those two days would be better for you, please let me know,as we will be happy to try to accommodate you.

Sincerely yours,

C VWO

FREDERIC L. elONWAY IIIExecutive SecretaryVeterans Advisory Committeeon Environmental Hazards

Enclosures

OF GENERAL COUNSELa a 20420

(02C)

Alvin L. Young, Lt. Col., Ph.D.Senior Policy Analystfor Life SciencesExecutive Office of the PresidentWashington, D.C. 20506

Dear Dr. Youngs

Public Law 98-542 called for the establishment of a VeteransAdvisory Committee on Environmental Hazards. The two areasthat are of specific concern to the Committee are the healtheffects of exposure to dioxin and to ionizing radiation as aresult of participation in the atomic weapons program or ofservice with the occupation forces of Hiroshima and Nagasaki,Japan. The first meeting of the Committee is scheduled forApril 22 and 23, 1985, at the Veterans Administration CentralOffice, 810 Vermont Avenue, N.w., Washington. For yourinformation, I am enclosing copies of the Committee's charterand membership roster.

I thought it would be helpful at the outset for the Committeeto receive a briefing on the use of herbicides in Vietnam andsome of the major iniatives undertaken by the Federalgovernment in response to concerns expressed by Vietnamveterans. I would appreciate it very much if you would bewilling to address the Committee on the herbicide issue onMonday afternoon, April 22, 1985. If another time on eitherof those two days would be better for you, please let me know,as we will be happy to try to accommodate you.

Sincerely yours,

FREDERIC L. CONWAY IIIExecutive SecretaryVeterans Advisory Committeeon Environmental Hazards

Enclosures

VeteransAdministration

Date: FEB 20 1985

MemorandumTo:

Administrator (00)

From:

Sub):

Special Assistant to the General Counsel (02C)

Charter for the Veterans' Advisory Committee on EnvironmentalHazards

Attached for your approval is the charter for the Veterans'Advisory Committee on Environmental Hazards. This Committee isa statutory committee established by section 6 of Pub. L. No.98-542, the "Veterans' Dioxin and Radiation ExposureCompensation Standards Act."

7/icA* s_. /' Qrvtw*1*/ &FREDERIC L. CONWAI III

A t t .

C o n c u r I A p p r o v a l : _<L__.(00) 4-1985

JV

VA FORM 210SMAY 1983

U.S. GOVERNMENT PRINTING OFFICE: 1984-421-488/0348

CHARTER

FOR THE

VETERANS' ADVISORY COMMITTEE

ON ENVIRONMENTAL HAZARDS

A. Committee's 'Official Designation:

Veterans' Advisory Committee on Environmental Hazards

B• Objectives and Scope of the Committee:

The committee is established pursuant to Section 6 of Pub. L.No. 98-542, the Veterans' Dioxin and Radiation ExposureCompensation Standards Act. It will advise the Administratorof Veterans Affairs concerning the scientific and medicalevidence of adverse health effects from exposure to herbicidescontaining dioxin on to ionizing radiation. Public Law No.98-542 mandates regulations to promote uniformity andconsistency in the adjudication of veterans' and survivors'compensation claims based upon disabilities or deaths allegedto result from exposure, in the case of Vietnam veterans, to aherbicide containing dioxin, and in the case of veterans whoparticipated in atmospheric testing of nuclear weapons or theoccupation of Hiroshima or Nagasaki, Japan, to ionizingradiation. The Committee will also advise the Administratorconcerning these regulations and later amendments.

C. Period of Time Necessary to Carry Out the Committee'sPurpose :

As a statutory committee established pursuant to Pub. L. No.98-542, the Committee will serve for an indefinite period.

D. Agency Official to Whom the Committee Reports:

The Committee will report to the Administrator of VeteransAffairs .

E« Agency Responsible for Providing Necessary Support :

Veterans Administration.

•V.V

rs~>.:t:'"

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F. Duties and Functions of the Committee:

1. The Committee shall consist of fifteen members appointed bythe Administrator after requesting and considering recom-mendations from veterans service organizations. During thefirst year, one third of the members will have a one year term,one third will have a two year term and one third will have athree year term. Thereafter, the term of service for eachmember shall be three years. The Administrator may reappointany member for additional terms of service. Eleven of themembers shall have expertise in biomedical and environmentalsciences, including three experts in fields pertinent tounderstanding the health effects of exposure to dioxin; threeexperts in fields pertinent to understanding the health effectsof exposure to ionizing radiation; and five experts in fields,such as epidemiology and other scientific disciplines,pertinent to determining and assessing the health effects ofexposure to dioxin or ionizing radiation in exposedpopulations. These eleven members shall comprise theScientific Council of the Committee. The remaining fourmembers shall be individuals from the general public, includinga disabled veteran, who have demonstrated an interest in andexperience relating to veterans' concerns regarding exposure todioxin or to radiation. The Chief Medical Director and theChief Benefits Director are ex officio, non-voting members ofthe Committee.The Administrator shall appoint the Chairpersonof the full Committee and of the Scientific Council.

2. Pub. L. No. 98-542 requires the Administrator to promulgateregulations setting forth the circumstances under which serviceconnection for disabilities resulting from specific diseasesmay or may not be established. In the case of Vietnamveterans, the diseases include chloracne, porphyria cutaneatrfrda, and soft tissue sarcomas; in the case of veteransexposed to ionizing radiation as a result of participation inatomic weapons testing or service with the occupation forces ofHiroshima or Nagasaki, Japan, the diseases include mostleukemias; cancers of the thyroid, female breast, lung, bone,liver, and skin; and polycythemia vera. Other diseases may beadded. Regulations pertaining to these diseases must be based

upon sound medical and scientific evidence. In addition, theAdministrator must evaluate the evidence concerning diseasesalleged to result from exposure and publish the evaluations inthe Federal Register. The regulations must explain how theseevaluations are to be used in claims adjudication. Indeveloping these regulations, the Administrator may consultwith the Committee. Before the regulations are made final, theAdministrator must consult with the Committee and theScientific Council.

3. The full Committee will submit to the Administrator anyrecommendations it considers appropriate for administrative orlegislative action. Taking into account the advice of theScientific Council, it will specifically provide advice andrecommendations concerning the guidelines and standards andcriteria proposed by the Veterans Administration for theresolution of claims for benefits under laws administered bythe Veterans' Administration based upon exposure to dioxin orto ionizing radiation.

4. The Scientific Council will consist of two eight-memberpanels, one focusing on issues relating to exposure to dioxinand the other focusing on issues relating to exposure toionizing radiation. The Chairperson of the Council shalldesignate the members of each panel. Each panel will evaluatescientific studies relating to their particular subjectmatter. The full Council will make findings and evaluations inlight of the appraisals of the respective panels regardingpertinent scientific studies and will make periodic reports tothe Committee and to the Administrator directly on suchfindings and evaluations. The Council and the panels will alsoconsider whether there is sound scientific and medical evidenceindicating a connection between particular diseases andexposure to dioxin or ionizing radiation and the Council willadvise the Administrator of its conclusions in light of theto *-*

advice of the appropriate panel.

G. Estimated Operating Costs:

The estimated annual cost for operating the Committee is$50,000 and approximately two person years.

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H• Number and Frequency of Meetings :

The full Committee will hold at least one meeting per year.The Scientific Council will hold at least one additionalmeeting per year.

•

I. Termination Date:

Unless the authorizing statute is repealed by Congressionalaction, the Committee will have no termination date.

J. Date Charter is Filed:

VETERANS' ADVISORY COMMITTEEON ENVIRONMENTAL HAZARDS

RADIATION

James V. Neel, M.D., Ph.D.Professor of GeneticsUniversity of MichiganMedical School1137 Catherine StreetAnn Arbor, Michigan 48109

Arthur C. Upton, M.D.Institute of Environmental MedicineNew York University Medical Center550 First AvenueNew York City, New York 10016

Edward W. Webster, Ph.D.Department of RadiologyMassachusetts General HospitalBoston, Massachusetts 02114

DIOXIN

James S. Taylor, M.D.Department of DermatologyCleveland Clinic FoundationCleveland, Ohio 44106

George D. Lathrop, M.D., Ph.D.JRB Associates9901 Interstate 10 WestSan Antonio, Texas 78230

Walter Melvin, M.D.Professor of EnvironmentalHealth SciencesColorado State UniversityFort Collins, Colorado 80523

GENERALISTS

Michael Bender, M.D.Brookhaven National LaboratoryBuilding 490UptonLong Island, New York 11973

2.

Leonard T. Kurland, M.D., Dr. P.M.Department of Medical Statisticsand EpidemiologyMayo ClinicRochester, Minnesota 55905

Theodore Colton, Sc.D.Professor of Public HealthBoston University Schoolof Public Health80 East Concord StreetBoston, Massachusetts 02118

Warren K. Sinclair, Ph.D.PresidentNational Council on RadiationProtection and Measurements7910 Woodmont AvenueBethesda, Maryland 20814

Armon F. Yanders, Ph.D.Professor of Biological Sciencesand Director, Environmental TraceSubstances Research CenterUniversity of MissouriColumbia, Missouri 65201

LAY MEMBERS

Mr. Oliver Meadows — ChairmanRoute 1, Box 173Godley, Texas 76044

Mr. Gerald C. Bender, Jr.1230 5th Street, N.E.Minneapolis, Minnesota 55413

Col. Eileen M. Bonner1 Constitution Avenue, N.E.Washington, D.C. 20002

Honorable Michael D. ZimmermanSupreme Court of UtahRoom 332State Capitol BuildingSalt Lake City, Utah 84114

MondayApril 22, 1985

Part V

VeteransAdministration38 CFR Parts 1 and 3Adjudication of Claims Based onExposure to Dloxln or Ionizing Radiation;Proposed Rules

15MO Federal Register / Vol. 50, No. 77 / Monday, April 22, 1985 / Proposed Rules

VETERANS ADMINISTRATION

38 CFR Parti 1 and 3

Adjudication of Claims Bas«d onExposure to Dloxln or IonizingRadiation

Aoencv: Velerani Administration.ACTION: Proposed rules.

SUMMARY: The Veterans Administration( V A ) proposes the following regulationslo implement the "Veterans Uioxin andR m l i n l i o n Exposure CompensationRlnndar t l s Act." Pub. L. 98-542 (Oct. 24,1984). The Act requires that the VAconduct rulemaking regarding Itsguidelines for the adjudication ofcompensation claims based upondisabi l i t ies or deaths of certain veteranswho, while In military service, wereexposed to ionizing radiation orherbicides containing dioxin. The statedpurpose of the Act Is lo ensure ,compensation for "veterans who were . ',exposed during service (n the Armed ' •Forces In the Republic or Vietnam to aherbicide containing dioxin or toionizing radiation in connection withatmospheric nuclear tests or in . ;conneclion with the Americanoccupation of Hiroshima or Nagasaki,japan, for all disabilities arising afterIhn l service that are connected, baaedon sound scientific and medicalevidence, to such service."DATBS: Comments must be received on ;'•'or before July 22.1905. It is proposed to ,nmkfl these rules effective thirty daysaf ter date of publication of the final »..rules with the exception of | 3.613 which.is proposed to be effective October 1,, ,1084, as required by law. ' ' ,ADDHESSES: Interested persons are ' '• ' ••invited lo submit written comments,suggestions, or objections regardingtlmse rules lo Administrator of VeteransA f f w i r s (271A)i Veterans Administration,610 Vermont Avenue, NW,, Washington,DC 20420. All written commentsreceived will be available for publicInspect ion only at the Veterans ServicesU n i t , room 132, at the above addressonly between the hours of 8 a.m. and4:30 p.m. Monday through Friday (excepthol idays) unt i l August 5.1905.FOR FURTHER INFORMATION CONTACT:Robert M. White, Chief, RegulationsS l a f f , Compensation and PensionService. Deportment of Veteransnonef i ls (20Z) 389-3005.suppueMtNTARV INFORMATION: The VAndminis lcrs compensation programs forvc le rnns disabled as a result of Injuriesor diseases Incurred or aggravatedd u r i n g mi l i t a ry service, and for survivorsof veterans whose deaths result from .

such service connected causes. Monthlybenefits are paid at statutory rates ." ,'•which vary with the level of disability •or, for survivors, with the military pay . ,grade of the deceased. Nearly two andone-quarter mlHioiweterans and 400,000survivors are currently receiving these t.'payments. !

In certain cases, eligibility under these :

.programs may arise If a veteran's . , ..'disability or death can be traced, to 'exposure, during military service, toionizing radiation or dioxin. Under Pub.L. 98-542. VA Is to set forth, for publiccomment, "guidelines and (whereappropriate) standards and criteria" forIts resolution of two categories of suchclaims: those based on exposure to -•>herbicides containing dioxin (e.g.,"Agent Orange") during service in theRepublic of Vietnam, and those basedon exposure to Ionizing radiation Inconnection with participation In theatmospheric testing of nuclear weapon!or the American occupation ofHiroshima or Nagasaki, Japan, at theclose of World War II.

Section 5 of the hew law specifies thatregulations be Issued to guide VAadjudication personnel In deciding themerits of these claims. The regulations•re to ensure continuation of VA'scurrent policy of granting claimants thebenefit of the doubt when there is anapproximate balance of positive andnegative evidence regarding anymaterial issue. The regulations are also .

' to carry forward current policy of .denying claims If the evidence makesclear that disability or death was causedby some post-service occurrence orresulted from the veteran's own willful,. :

misconduct.' ' , 'These rules art to specify whether, s"

and if so under what circumstances,certain diseases are to be recognized asconnected to • veteran's exposure. The.rules are to be grounded in "sound •scientific and medical evidence." Withrespect to Vietnam veterans exposed to

. herbicides containing dioxin, the ' •'diseases for which rules must be issued 'are chloracne, porphyria cutanea tarda,and soft tissue sarcoma. For veteransexposed to ionizing radiation under thespecified conditions, the diseases for . .which rules must be issued areleukemias, polycythemia vera, and

. malignancies of the thyroid, female. ;breast, lung, bone, liver and skin. . .'Additionally, the rules are to indicate .(•'•

' how claims will be handled If based -:

upon other diseases for which the • •Administrator finds there is sound 1

. scientific or medical evidence Indicating;a connection with such exposures. '" .

; In additioh, the VA is to publish '....,'.' guidelines for its evaluation of studies',;.;' into the health effects-of exposure to' .''

ionizing radiation or herbicidescontaining dioxin, and give notice ofthese evaluations by publication in theFederal Register.

Section 6 of the Act authorizes a new"Veterans' Advisory Committee onEnvironmental Hazards." The 15-

i member committee, composed of an 11-member Scientific Council and 4 laymembers, will formally consider theseproposed regulations and mayrecommend changes before final rules•re published. The panels of theScientific Council are also responsiblefor advising the Administrator as toadditional diseases to be covered by the

•regulations and respecting the studyevaluations discussed above.

Finally, these regulations implement ;Section 9 of the Act, which authorizes"interim benefits" for certain Vietnamveterans. .

° Section 1.17 Study evaluations.This section, to be added to Part 1 of

' 38 CFR Chapter I, relating to GeneralProvisions, provides a formal process forthe Agency's evaluations of scientific

• and medical studies relating to the• possible adverse health effects of dioxin

or radiation exposure. As contemplatedby section S(b) of the Act, theevaluations would be published fromtime to time In the "Notices" section ofthe Federal Register, In addition tostatutory criteria—whether the findings•re statistically significant, have

t withstood peer review, and are capable. of replication—these evaluations would

consider the views of the appropriatepanel of the Scientific Council of theAdvisory Committee and thesignificance of the study findings for

• veterans exposed to dioxin or Ionizing. radiation during military service.

' "Statistical significance" Is used by'•" scientists and medical personnel to• generalize the results of an investigation

of a aample, e.g., laboratory experiment,•n opinion boll, or an extensive "headcount," to the relevant population. Testsfor statistical significance estimate the

• chance that the investigation's resultswould have been achieved if the

; population had particular'characteristics. The desired numericalvalue for statistical significance varies

- depending upon the Information sought•" and how certain the scientists want toi,' be that the results are not due to chance..'• Selection of these values depends upon

the judgment of expert, qualifiedscientists, but In the absence of

"' compelling evidence is based uponV conventionally accepted numerical, .values.." f* "Peer review" Is an accepted means of

assuring scientific quality. It ordinarily

Federal Rogtutor / Vol. 50. No. 77 / Monday. April 22. 19B5 / Proposed Rules 15049

Is performed by a group of a scientist'*superiors or peers who review theresearch when it Is completed todetermine whelher it has been properlyconducted and whether the conclusionsdrawn are justified by the resultsobtained. Ordinarily the review groupsare constituted within the scientist'sorganization, whether academic,governmental or private, often withparticipation by outside experts.Suction 3.102 Reasonable doubt policy.

This unction of Pnrl 3, Adjudication, isreworded and simplified. Since the1920's. the purpose of the "reasonabledoubt policy" has been to assure theresolution of close issues, material to theclnim, In the claimant's favor wheneverIt In hot unreasonable to do so.

Decisions on material issues—usually,Issues that must be resolved In theclaimant's favor If the benefit Is to begranted—are made only after allavailable evidence has been assembled.If the evidence of record supports theclaim and is adequately probative, thereIs no need for the application of thereasonable doubt policy. Conversely, Ifthe evidence Is Insufficient to support(he clnim, the policy should not beapplied. Entitlement should never bebased on speculation or remotepossibility. It sometimes happens,however, that the evidence supportingtho clnim Is counterbalanced by otherevidence thnt creates a reasonable .doubt o« to the claim's merits. In thistype of situation, the reasonable doubtIs to be resolved tn the claimant's favor.

Section 5(n)(2) of the Act directs theAgency to assure that this policy,reformulated in section 2(13) of the Act,applies to dioxin and radiation exposureclaims. Proposed new if 3.31la andI 3.311b (br>low) accordingly refer toi 3.102, To avoid possible confusionfrom alternative formulations, thisregulatory proposal would realign thetext of J 3.102 in accordance with thecongressional reformulation. No • 'substantive alteration of the :

"reasonable doubt" policy Is intended.Section 3.31 la Diox/nrule.

This section, to be added to 38 CFR •Part 3, provides guidelines and criteriafor the resolution of veterans' claimsbused on exposure to a herbicidecontaining dioxin during military servicein the Republic of Vietnam during theVietnam era.

Uackground, Beginning In the 1940's,phnnoxy herbicides were widely used inthe United States and elsewhere by ,farmers, foresters, and homeowners. 'Herbicides were used during the :Vietnam conflict to defoliate trees,remove ground cover, and destroy crop*.

Shipped In orange-striped barrels, AgentOrange was a liquid containing twochemicals, one of which, 2,4,5-Irlchlorophenoxyacetlc acid (2,4,5-T), Iscontaminated during the manufacturingprocess by 2,3,7,8-tetrachlorodibenzo-p-dioxln, also known as TCDD or, morepopularity, dioxin. The contaminantdioxin, first Identified in the 1960's, Is ofspecial concern because studies haveshown it to be highly toxic to certainanimal species. More than 2,4 millionUnited States military personnel servedin Vietnam. Many were deployed In ornear locations where Agertt Orange was•prayed, and others—particularly theRanch I land group—participated in the•praying operations directly.

According to The Toxicology,Environmental Fate, and Human Risk ofHerbicide Orange and Its AssociatedDioxin (USAF Technical Report No.OEHL TR-78-92,1978), about 10.6million gallons of herbicides were•prayed in Vietnam, with a menn dioxinconcentration of about 2 parts permillion. During the 7-year period ofAgent Orange use, about 3 million acre*were sprayed at various times. Themean distribution of dioxin per acre IBestimated at 0.00013 pounds (O.Oflgrams). Dioxin is photo-degradahle, thatIs, it decomposes in sunlight. 1 he soilconcentration Is estimated at 0.016 partsper billion.

There are other sources of humandioxin exposure besides Agent Orange,for example, exposure from industrial •accidents, contaminated industrialwastes, farming and ranching herbicideapplications, transportation accidents,and hexachlofaphene, a germlcldalagent widely used in the 1950'* and1900's.

Definitions. The term "dioxin" mayrefer to one of several chemicals. This•ectlon uses dioxin to refer only to2,3,7,8-tetrachlorodibenzo-p-dioxfn, theAgent Orange contaminant. Because•ome military personnel stationed 'elsewhere may have been present in theRepublic of Vietnam, "service In theRepublic of Vietnam" will encompass

> services elsewhere If the personconcerned actually was In the Republicof Vietnam, however briefly.

The law requires these regulations to•pecify the circumstances under whichservice connection may be establishedfor disability resulting from chloracne,porphyrla cutanea tarda (PCT), or softtissue sarcoma. These rules are to bebased on sound scientific and medical

, evidence. In this section, "soundscientific evidence" consists of findings.that are statistically significant,withstand peer review, and are capableof replication. "Sound medical' •

; evidence" means studies consonant

with medical knowledge andconclusions on which medical treatmentcould be prudently based.

Exposure. In view of shiftingpersonnel deployments, absence of on-site measurement of dioxincontamination and other factors, theAgency has adhered to a policy ofpresuming exposure if the veterans•erved in Vietnam during the relevantperiod. This section formalizes thatexisting policy.

Service connection. At the presenttime, there is sound scientific andmedical evidence that chloracne, a skindisorder, can result from dioxinexposure. See, e.g., Crow, K.D.,Significance of Cutaneous Lesions In theSymptomatology of Exposure to Dioxinsand Other ChloracncgenS, In Humanand Environmental Risks of ChlorinatedDioxins and Related Compounds(Tucker ct al., ed., Plenum Press, 1983).Chloracne may subside spontaneously,but it can be a chronic condition.Industrial accident follow-up studiesIndicate that chloracne associated withdioxin exposure is manifest within daysor weeks. This section provides that aveteran's disabling chloracne may beservice connected if the first symptomsappeared within three months of the

. veteran's departure from the Republic ofVietnam.

PCT. Investigators concerned about• the possible deleterious effects of Agent

Orange exposure located studies ofIndustrial accidents involving phenoxy

, chemicals In which some exposed • . ••Individuals developed porphyriacutanea tarda (PCT). This is a relativelyrare liver disorder also found in certainIndividuals who have a history ofalcoholism. Further Investigations haverevealed that the PCT manifested in theIndustrial accidents occurred whenworkers were also exposed tohexachlnrohenzene, a known potent

• cause of PCT. See, e.g., Pazderova, et al.,. Chronic Intoxication by Chlorinated ' .

Hydrocarbons Formed During theProduction of Sodium 2,4,5

. trlchlorophenoxyacctate, 26(9) Prac. ,tek. 332 (1974). and Jones, R.E., Chelsky,

• M., Scrrpne, D.M., and Hillman, D.W., A' Reassessment of the Evidence Linking

Porphyria Cutanea Tarda to 2,3,7,8tetrachlorodibenzo-p-dioxln (TCDD)Exposure (Submitted to HumanPathology for publication), Soundmedical and scientific evidence does notsupport a causal association betweendioxin exposure and the development ofPCT. Hence, this section does not

: provide a basis for service connection,based on dioxin exposure, of a veteran's

• ' disabling PCT. Stift tissue sarcomas.Malignancies in the soft tissue sarcoma

15050 Federal Register / Vol. 50, No. 77 / Mondny, April 22, 1905 / Proposed Rules

ceilr-gory nre relatively rare. While moatof these mnlignRncies are of unknownetiology, prolonged exposure 1o asbestosfibers is known to be a causative fnctorin the development of mesothelioma,sometimes classified as one of thesesiircomos. Dioxin has not been shown tobe a htimnn carcinogen. Studiesconducted in Sweden in the 1970'ssurest a relntionship between exposureto phenoxy herbicides and thesubsequent development of soft (issuesnrcomns, but studies publishedelsewhere, including studies in theUnited Slates, do not confirm theSwedish studies' hypothesis. See, e.g.,Fingerhul et«!., An Evaluation ofReports of Uioxin Exposure and SoftTissue Sarcoma Pathology AmongChemical Workers in the United States,10 Scand. /. of Work, Environment andHealth 299 (19M), and Riihimaki, V., etfll., Mortality of 2,4-D and 2.4,5-TIHbicide Applicators in Finland, 6Scand. f. of Work, Environment andHealth 37 (1982). At the present lime,sound scientific and medical evidence .does not afford a basis for a causalnssocialinn between dioxin exposureand the development of malignancy ofthe soft tissue sarcoma group. Hence,this section docs not provide for serviceconnection, based on dioxin exposure,of disability resulting from thesediseases.

Exceptions. This section provides thatchloracne may not be established asservice connected If the disabilityresulted from the veteran's own willful .misconduct or there is a supervening,nonservice-connected cause of thedisease.

Construction, Nothing fn this sectionis to be construed as preventing theestablishment of service connection fora disability that had its origin in militaryTrvfce. For example, a veteran sufferingfrom PCT or a soft tissue sarcoma mayestablish service connection based ondirect evidence that it existed in serviceor, in the case of a sarcoma, based onsymptoms to a compensate degreewithin the one-year statutorypresumptive period following dischargefrom service (see 38 U.S.C. §5301, 3121.

Evaluations. This section provides forthe appropriate use of study evaluationspublished in the "Notices" lection of theFederal Register.Section 3.31ib Radiation rule.

This section provides guidelines andcriteria for the resolution of claims for 'service connection of disabilities basedon exposure to ionizing radiation as aresult of participation in the atmospherictesting of nuclear weapons, theoccupation of Hiroshima and Nagasaki,japan, at the close of World War II, or

other service activities. This sectionwould replace existing } 3.311, whichwould be removed.

Background. Radiation exposuresover which veterans have expressedgreatest concern are those occurringduring atmospheric nuclear testing andthe occupation of Hiroshima andNagasaki. From 1945 through 1962, theU.S. Atomic Energy Commissionconducted some 235 atmospheric tests ofnuclear weapons, principally in Nevadaand the Pacific Ocean. Approximately203,000 American military personnelparticipated in one or more of thesetests.

To address concerns regarding •possible health effects to testparticipants, the Defense NuclearAgency (DNAJ established the NuclearTest Personnel Review (NTPR) programin 1977, Among the objective* of thisprogram are identification of personnel 'involved In testing and compilation ofavailable information on exposurelevels. Extensive dose reconstructionhas also been undertaken to calculatedoses received by participating unitsand individuals and as a check onrecorded dose information from filmbadges worn by test participants.Research conducted under the NTPRprogram indicates over 99 percent ofatmospheric nuclear test participantsreportedly received doses of 5 rem orless. To place this in perspective. 5 remIs the current Federal guideline forallowable annual radiation dose forradiation workers.

The bombings of Hiroshima andNagasaki occurred In early August 1945.The first American occupation forcesarrived in the vicinity of the Hiroshimabombing site 60 days after the bombing.Occupation forces arrived in Nagasaki45 days after the bombing. Militaryrecords show that 11,000 men werebilleted for at least a week during 1945-46 inside the city limits of Hiroshimaand Nagasaki. Approximately 110,000personnel spent at least one day within10 miles of the city limits. An estimated350,000 personnel were within 100 milesof Hiroshima and Nagasaki.

Substantial knowledge of residualradiation at these locations was derivedfrom on-site surveys conducted shortlyafter the bombing and from extensive

1 scientific reconstructions. Severalfactors. Including the lapse of timebetween the bombing and theoccupation, heavy rains during thisperiod, the high burst altitude of thebombs used, and the brief duty lours of

! occupation participants combined to, minimize exposure levels of the

occupation forces. Analyses performed'by the DNA Indicate the highestradiation dose any occupation force

participant could have received was lessthan one rem.

Ionizing radiation. Ionizing radintionIs radiation having sufficient energy tofree electrons from atoms. The resultingions are capable of causing damage tohuman tissues. Ionizing radiationIncludes both electromagnetic radiation,e.g., gamma rays, and particulateradiation, e.g., alpha particles.

Exposure. Shifting personneldeployments, absence of on-sitemeasurement of dioxin contaminationand other factors make estimation of theextent of dioxin exposure for aparticular veteran extremely difficult. Incontrast, radiation exposure generallyoccurred in clearly defined areas onspecific occasions, and measures weretaken to monitor exposure levels. Thus,a veteran's in-service radiation dose cangenerally be estimated with relativeprecision. The proposed regulationsdefine procedures for estimatingradiation dose.

Procedures for service-connectiondeterminations, Proposed § 3.311b isdesigned to ensure fairness to claimantsand consistency and accuracy in theadjudication of radiation exposureclaims. Procedures governingdevelopment of evidence, provisionspresuming exposure in the absence ofadequate records, use of outside expertsand consultants, and reference toapplication of the reasonable-doubt •standard are among the features of the'proposed regulation designed to assurefair treatment of all claimants. •Consistency and accuracy will bepromoted by specification of minimumstandards for extended consideration ofclaims and by clear definition of factorsto be considered at each stage.

Under proposed f 3.3l1b(b), an Initialreview of claims based upon radiationexposure would be made in order toidentify claims meriting furtherconsideration under { 3.311b(c). The VAbelieves standards and criteria, i.e., firmrules of decision, are appropriate inconnection with this initial review.

Principles governing the disabilitycompensation program precludeestablishment of service connection,based upon radiation exposure, unless itcan be concluded that exposureoccurred as claimed. Further, the VAdoes not believe a claim meritsextended consideration under proposed§ 3.31lb unless it involves a diseaseassociated with radiation exposure.Proposed ( 3.311 b(b)(2j specifies thosediseases which may be considered toresult from radiation exposure Finally, .the proposed rule specifies that furtherconsideration of a claim under | 3.311bis unnecessary If a veteran's disease

* •

Federal Rngislor /. Vol. SO. No. 77 / Monday, April 22. 1985 / Proposed Rules 15851

brciime monifnsl either before or after iIhn period following exposure duringwhich the di.iense, if related toexposure, would be expected to develop.Under the proposnl, if these minimumcriteria ore met. further consideration ofthe claim under proposed { 3,311b willbp accorded.

Proposed §3.311b(rJ(l) provides thatclnims meeting the initial review criteriawill be referred to the Chief MedicalDirector. Under the proposed regulation,if the Chief Medical Director isconvinced sound scientific nnd medicalevidence supports the conclusion it is atleiisl ns likely ns not the veteran'sdisease resulted from radintion exposurein service, the Chief Medical Directorwill provide the Chief Benefits Directorwith a written evaluation supporting thisconclusion. If the Chief Medical Directordetermines there Is no reasonablepossibility the veteran's disease resultedfrom such exposure, he will so Informthe Chief Benefits Director. For purposesof this section, the same definitions of •sound scientific and medical evidencestated in proposed 8 3.311a, pertainingto dioxin exposure, would apply.

In making determinations underproposed § 3.311b(c), the Chief MedicalDirector would consider the factorsspecified In proposed 5 3.311b(e). These •factors are Intended as guidelines, or 'guidance to the decisionmakcr, ratherthnn standards or criteria. The VAconsiders proper claims resolution torequire a balancing of these factors on acase-by-case basis. The factors specifiedarc generally recognized In the medicaland scientific literature as influencingthe likelihood that a specific type ofcancer Is radiation Induced. See, e.g.,Committee on the Biological Effects«ofIonizing Radiations, The Effects onPopulations of Exposure to Low Levelsof Ionizing Radiation: 1900 (BE1R IIIreport). However, at present, the relativeweight of these factors is not susceptibleto precise definition.

Proposed S 3.311b(c)(2) provides forreferral of a claim to a consultantoutside the VA when the Chief MedicalDirector Is unable to determine whetherit is at least as likely as not. or that thereis no reasonable possibility, theveteran's disease is due to radiationexposure in service. Under proposedi 3.311b(d), the Chief Medical Directorwould select the consultant after , .| receiving the recommendation of the| Director of the National Cancer

Institute. The Chief Medical Directorwould ask the consultant to evaluate theclaim using the factors specified inproposed § 3.311b(e) and provide an

I opinion as to whether It Is likely, iI unlikely, or approximately as likely as

not the veteran's disease resulted fromexposure to radiation in service. The ' •consultant's opinion would providevaluable evidence for consideration bythe Agency.

In all cases, the VA's Department ofVeterans Benefits would adjudicate theclaim under generally applicableprocedures. Adjudication officials wouldgive due consideration to all evidence ofrecord, Including any consultant'sopinion, and to the policy of resolvingreasonable doubt in favor of theclaimant. Appeals of adverse decisionscould be taken to (he Board of Veterans .Appeals.

Proposed § 3.311b(a)(2) would providefor referral to the Department ofDefense, for a dose estimate, allradiogenic-disease claims based onexposure during atmospheric nuclearweapons testing or during theoccupation of Hiroshima and Nagasaki.In other claims where radiationexposure is alleged, the Chief MedicalDirector would review records bearing 'fen the veteran's radiation dose and 'apply available methodologies inpreparation of a dose estimate.

Under proposed { 3.311b(a)(3), if aclaimant submits a radiation doseestimate from a credible source whichdiffers materially from the estimatederived from official sources, anindependent expert selected by theDirector of the National Institutes ofHealth will be asked to prepare aseparate dose estimate for considerationwith all other evidence In adjudicationof the claim, To assure this procedure,will be invoked only where differingestimates have been prepared byqualified persons having a familiaritywith the claim at issue, a dose estimatewould be considered from a crediblesource only if It was prepared by aperson or persons certified by anappropriate governing body in the fieldof nuclear medicine or radiology andwas based on analysis of the facts andcircumstances of the veteran's exposure.

The difference between a claimant'scredible-source estimate and the doseestimate from official sources wouldordinarily be considered material andrequire referral to an independentexpert if one estimate Is at leasf doublethe other. However, the VA Intendsflexibility in application of thisprovision based on the circumstances ofthe individual claim. It Is anticipated 'that, in claims Involving high doses,

> referral to an independent expert may' be appropriate in some cases even

though one dose estimate is less thandouble the other. Conversely, when both,estimates are very low, referral may not

i be necessary where, although one

estimate Is double or more than doublethe other, (he difference is too small Inbe of significance in adjudication of theclaim.

Basis for criteria. The VA considersthe proposed criteria for evaluation ofradiation claims fully supported bysound scientific nnd medical evidenceand consistent with the policy ofresolving reasonable doubt In fuvor ofthe claimant. In light of such evidence,the VA has tentatively concluded Ihntservice connection based nn radiationexposure may be established for eachdisease referred to in section 2(5) of Pub.L. 98-542. with the exception ofpolycylheinia vera and chroniclymphatic leukemia. The BF.IR Id report,page 207, Table A-l, indicated chroniclymphatic leukemia has not beenobserved as resulting from radiationexposure. The VA intends to request theadvice of the Veterans' AdvisoryCommittee on Environmental Hazardsas to whether sound scientific andmedical evidence exists linking theseand other diseases to radiation exposureand anticipates that additional diseasesmay be included In the regulation asradiogenic diseases in the future,

Studies reviewed in the BEIR 111 reportdo not suggest a causal connectionbetween skin cancer and low doselevels of ionizing radiation. Aconnection between skin cancer andradiation exposure at high dose levels iswell-established, and skin cancer has,therefore, been Included as a radiogenicdisease in proposed 6 3.311b(b)(2). TheVA notes the apparent absence of soundscientific and medical evidencesupporting an association between skincancer and exposure to low levels ofIonizing radiation.

The proposed regulations state thatsound scientific and medical evidencedocs not establish a connection, betweenpolycythemia vera and radiationexposure. One study (Glyn G. Caldwell,et a!., Polycythemia Vera Among 'Participants of a Nuclear WeaponsTest, Journal of the American MedicalAssociation, Vol. 252, pp. 662-664 (19B4))of the health and mortality ofparticipants In the "Smoky" atmosphericnuclear test found a greater thanexpected incidence of polycythemiavera among test participants. However,the lack of other supportingdocumentation suggests the apparentexcess of polycylhemia vera cases mayhave resulted from chance ormisdiagnosis. Despite the proposedexclusion of polycythemia vera from thelist of radiogenic diseases in :

{ 3.311b(b)(2). service connection may |nonetheless be established under'generally applicable adjudication

Federal Register / Vol. 50, No. 77 / Monday, April 22, 1905 / Proposed Rules

regulations for polycylhcmla verabecoming manifest during a veteran'speriod of service.

In order to provide evoiy reasonableconsideration to veterans seeking loeslnbllsh service connection, the VA hasproposed use in § 3.311b(b)(4) of thebrondrst periods of expected Incidencesupported by sound scientific andmedical opinion. In particular, the DEIRIII report staled thnt excess leukemias ,nnd bone cancers hnve been observed • .within 2 to 4 ycnrs after radiation ,exposure, but that evidence Indicate! • • •the increased risk of these cancers • • ' . ;becomes negligible 25 lo 30 years afterirrndi:ilion. The report goes on lo slate 'that, for all other radiation Inducedcancers reviewed, the minimal Intentperiod Is 10 years or more, and there lano Indication increased cancer riskeventually declines. See BEIR III report,pnge 193.

Pmbobility-of-Causation Tabfas. TheOrphnn Drug Act, Pub. L. 97-414,7(b), 96Slut. 2049, 2000 (1983), directed theDepartment of Health and HumanServices (I HIS) fo develop and updaterndioepidemlologlcal tablet relating tothe probability that certain cancers .could result from prior exposure toradiation. The resulting tables have onlyrecently become available. '

Because of a lack of data regarding i ;the health effects of low-level radiationexposure, the reliability of any suchtables at the lower doses and for certaincancers would be open to somequestion. In fact, the VA notes that theAd Hoc Working Group whichdeveloped these tables Identified manysignificant sources of uncertaintyassociated with (he tables. Report of theNational Institutes of Health Ad HocWorking Croup lo Developflnrtifjrpidemiologwal Tables 79-115(1900). Therefore, the proposedregulntions do not adopt the use of theIII IS tables, but VA has (ought theguidance of the Committee on " • , . , ;InOragency Radlallon Research and • ."•Policy Coordination (CIRRPC) of the \Federal Coordinating Council for. ' ,Science, Engineering and Technology(KCCSET) in order lo asses the potentialutility of employing the tables in some • ,fnshion to adjudicate veterans' •• •compensation claims, The Veterans'Advisory Committee on EnvironmentalI faznrds will also be asked for Its viewson this subject.

Section 3.013 Special interim benefits.

This section Implements section R ofthe Act. A Vietnam veteran disabledfrom chloracne or PCT would be eligible 'for special Interim benefits if the diseasebecome manifest within one year of theveteran's departure from Vietnam.

Interim benefits would be payable forthe two-year period beginning October1,1984, at (he same rale ascompensation for service-connecteddisability.'lf th*e veteran died from thedisease, the survivors would be eligiblefor Interim benefits, paid likedependency and Indemnitycompensation. Interim benefit* wouldnot be payable If there is affirmativeevidence that the disease was 'precipitated by a known cause (hatoccurred after the veteran's departurefrom the Republic of Vietnam. Also,Interim benefits would not be payable ifthe veteran (or survivor) Is receivingcompensation for disability (or death) • :resulting from the chloracne of PCr.

Regulatory Evaluations

The Administrator hereby certifiesthat these proposed regulations do nothave a significant economic Impact on asubstantial number of small entitles asthey are defined In the RegulatoryFlexibility Act, U.S.C. 601-612.Therefore, pursuant to 6 U.S.C. 605(b), .these proposed regulations are exemptfrom the initial and final regulatory .. , ,flexibility analyses requirements ofsection 603 and 604. The reason for thiscertification Is that these regulations .: ••impose no regulatory burdens on small

, entitles, and only claimants for VA ' ' 'benefits will be directly affected.

In accordance with Executive Order12291, Federal Regulation, the VA hasdetermined that these proposedregulations are non-major for thefollowing reasons.' (1) They will not havean effect on the economy of $100 millionor more; (2) They will not cause a majorincrease In costs or prices; (3) They willnot have significant adverse effects oncompetition, employment, investment,productivity, innovation, or on theability of United States-based . ,

'enterprises to Compete with foreign- < ;' bused enterprises In domestic or export »

markets. , i . . . . .

' List of Subjects la 38 CFR Part 3

, ' Administrative practice andprocedure, Claims, Handicapped, Healthcare, Pensions, Veterans. :

The Catalog of Federal DomesticAssistance program numbers are 64.109

, and 64.110.

Approved: April 12, IBM.Harry N. Walter*,Administrator.

38 CFR Part 1, GENERAL and Part 3.ADJUDICATION, ere amended asfollows: • • • .

PART 1-lAMENDED]

1. Part 1 Is amended by adding a newf 1.17 to read as follows:

f 1.17 Evaluation of studies relating tohtfttth effects of dloxln and radiationexposure.

(n) From time to lime, theAdministrator shall publish evaluntionsof scientific or medical studies relating10 the adverse health effects of exposureto 2,3,7,6 Ictrachlorodibcnzo-p-dioxin orionizing radiation In the "Notices"'section of the Federal Register.

(b) Factors to be considered inevaluating scientific studies include:

(1) Whether the study's findings arestatistically significant and replicable.

(2) Whether the study and its findingshave withstood peer review.

(3) Whether the study methodologyhas been sufficiently described to permitreplication of the study.

(4) Whether the study's findings .areapplicable to the veteran population ofinterest.

(5) The views of the appropriate panelof the Scientific Council of the Veterans'Advisory Committee on Environmental; 'Hazards.

(Pub. L. 98-542)

' PART 3—[AMENDED]

2. Part 3 is amended by revising| 3.102, by removing and reserving| 3.311 and by adding new 55 3.31 In.3.311b and 3.813 so that the new andrevised material reads as follows:

13.102 Sufficiency of the evidence:benefit of reasonable doubt to trie claimant

The policy of the VA In adjudicatingclaims Is to administer the law under abroad interpretation, consistent with thefacts shown In each claim. Evidencesupporting the claimant's position mustbe sufficient to justify a belief in a fairand impartial mind that the claim is wellgrounded. Entitlement to benefits maynot be based on pure speculation orremote possibility. When, afterconsideration of all evidence of record,

. there is an approximate balance ofpositive and negative evidenceregarding the merits of an Issue materialto a claim, the benefit of the doubt inresolving that Issue shall be given to theclaimant,(38 U.S.C. 210(c))

13.31 la Claims bated en exposure toherbicides containing dloxln during serviceIn the Republic of Vietnam.

(a) Definitions. For purposes of thissection:

(1) "Service In the Republic ofVietnam" includes service In the waters

•

Federal Register /Vol. 50, No. 77 / Monday, April 22, 1965 / Proposed Rules 15053

offshore and service in other locations,if the conditions of service involvedduty or visitation in the Republic ofVietnam.

(2) "Dioxin" means 2,3.7,8letrachlorodibenzo-p-dioxin. ••

(3) "Sound scientific evidence" meansobservations, findings, or conclusionswhich nre statistically significant, arecapable of replication, and withstand > .peer review.

(4) "Sound medical evidence" meansobservations, findings, or conclusionswhich arc consistent with currentmrdicfil knowledge and are soreasonable and logical as lo serve as thebasis for management of a medcialcondition. .

(b) Presumption of exposure. A .velernn who served In (he Republic ofVietnam during the Vietnam era shall b*presumed to have been exposed to aherbicide containing dioxin while In .Vietnam. 1'he commencement dale ofany period specified in paragraph (c) of •this section shall be the day of the ,veteran's latest departure from (he .Republic of Vietnam during such ', .service.. . ' • • . . .

(c) Service-connection based ondioxin exposure. Except as provided Inparagraph (e) of this section, exposurelo dioxin together with the developmentof the following disease within theperiod specified Is sufficient to establishservice-connection for resulting •disability: Chloracne manifested notlater than three months from the dale ofexposure. . . . , :

(d) Diseases not associated withdioxin exposure. Sound scientific andmedical evidence does not establish a .en use and effect relationship betweendioxin exposure and (he following:

(1) Porphyrla culanea tarda. ' ' . '(2) Soft tissue sarcomas.' ' "(3) Any other disease not specified in '

paragraph |c) of this section. '(e) Exceptions, Service-connection

will not be established if the claimeddisetise Is due to (he veteran's ownwillful misconduct or there is affirmative'evidence (hat establishes a nonservice-relaled supervening condition or event •as the cause of the disease.

(f) Study evaluations. In the ' ' 'Adjudication of individual claims, dueconsideration shall be given to theevaluations of study findings publishedpursuant to S 1.17 of this title.

(g) Service-connection under other \.provixinns. Nothing in this section willlie construed to prevent theestablishment of service-connection forany disease or disorder shown by sourednnientific or medical evidence to havelieen incurred In or aggravated by active

I service, [ • , / : • • • • • • . • ' ' ' • • ' , '

(h) Reasonable doubt doctrine. Withregard to any issue material to thedetermination of an individual claim, theprovisions of f 3.102 of this title shallapply. ' • ' •(Pub. L 0B-542) '

§ 3.311b ' Claims btstd on txposurt toIonizing radiation.

(a) Determinations of exposure anddose—(1) Dose assessment. In all claimsin which II is established Ihat aradiogenic disease, listed in paragraph(b) (2) of this section, first becamemanifest after service and was notmanifest to a compensable degreewithin any applicable presumptiveperiod as specified in f 3.307, and it iscontended the disease is a result ofexposure to ionizing radiation in service,an assessment will be made as to thesize and nature of the radiation dose ordoses. '

(2) Request for dose information.Where necessary pursuant lo paragraph(n) (1) of this section, dose Informationwill be requested as follows: ' •

(ij Atmospheric nuclear weapons test-participation claims. I n claims based > ,upon participation in atmosphericnuclear testing, dose data will In allcases be requested from the appropriateoffice of the Department of Defense.

(ii) Hiroshima and Nagasakioccupation claims. In all claims basedon participation in the Americanoccupation of Hiroshima or Nagasaki, .Japan, prior lo July 1,1946, dose datawill be requested from the Departmentof Defense.

(iii) Other exposure claims. In allother claims Involving radiation

; exposure, a request will be made for theveteran's Record of OccupationalExposure lo Ionizing Radiation (DD .Form 1141), If maintained, servicemedical records, and other records 'which may contain Informationpertaining to the veteran's radiationdose In service. All such records will beforwarded to the Chief Medical Director,who will be responsible for preparationof a dose estimate, to the extentfeasible, based on availablemethodologies.

(3) Referral to independent expert.When necessary to reconcile a materialdifference between an estimate of dose,from a credible source, submitted by oron behalf of a claimant, and dose data .derived from official military records,the estimates and supporting ' .

. documentation shall be referred lo anindependent expert, selected by the "

. Director of the National Institutes of :

Health, who shall prepare a separateradiation dose estimate for ' • ',considerations! In adjudication of the .

, claim. For purposes of (his paragraph:

(i) The difference between theclaimant's estimate and dose dataderived from official military recordsshall ordinarily be considered materialif one estimate is al least double theother estimate.

(ii) A dose estimate shall beconsidered from a "credible source" ifprepared by a person or personscertified by an appropriate governingbody In the field of nuclear medicine orradiology and If based on analysis of thefacts and circumstances of the particularclaim.' (4) Exposure. In cases described inparagraph (a) (2) (i) and (a) (2) (ii) of thissection:

1 (I) If military records do not establishpresence at or absence from a site atwhich exposure lo radiation is claimedto have occurred, the veteran's presenceat the site will be conceded,

(ii) Neither the veteran nor the, veteran's survivors may be required to

produce evidence substantiating ! r •exposure if the information in theveteran's service records or otherrecords maintained by the Departmentof Defense is consistent with the claimthai the veteran was present where andwhen the claimed exposure occurred.

(b) Initial review of claims. (1) Whenit is determined:

(1) A veteran was exposed to ionizing' radiation as a result of participation in

the atmospheric testing of nuclearweapons; the occupation of Hiroshimaor Nagasaki, Japan, from September1945 until July 1946; or other activities asclaimed; • • • • • '

(ii) The veteran subsequentlydeveloped a radiogenic diseasespecified in paragraph (b)(2) of thissection; and

(iii) Such disease first becamemanifest within the period specified inparagraph (b)(4) of this section; before •

. its adjudication the claim will bereferred to the Chief Medical Directorfor further consideration in accordancewith paragraph (c) of this section. If anyof the foregoing 3 requirements has notbeen met, it shall not be determined thata disease has resulted from exposure toionizing radiation under suchcircumstances. (But see paragraph (h) ofthis section.)

(2) For purposes of paragraphs (a)(l)and (b)(l) of this section, "radiogenicdisease" shall Include only thefollowing:

(i) All forms .of leukemia exceptchronic lymphatic leukemia;

(ii) Thyroid cancer;4

; (ill) Female breast cancer;.1 (iv) Lung cancer;

\v) Bone cancer /"' (vi) Liver cancer; and ' , ' '

15054 Federal Register / Vol. 50, No. 77 / Monday, April 22, 1985 / Proposed Rules

(vlli) Skin cancer.(3) For purposes of paragraphs (a)(l)

and (b)(1) of this section, "radiogenicdisease" shall not include polycylhemlavorn.

(4) For purposes of paragraph (b)(l) ofthis flection:

(I) Keukemias and bone cancer mustbecome manifest more than 2 years butless than 30 vnnrs after exposure;

|il) Other forms of cancer specified inparagraph (b)(2) of this section mustbecome manifest 10 years or more afterexposure,

(c) Revww by Chief Medical Director.(t) When a claim is forwarded forreview pursuant to paragraph (b)(l) ofthis section, the Chief Medical Directorshall consider the claim with referenceto the factors specified in paragraph (e)of this section.

(1) If after such consideration theChief Medical Director Is convincedsound scientific and medical evidencesupports the conclusion It Is at least aslikely as not the veteran's diseaseresulted from exposure to radiation Inservice, the Chief Medical Director shallno Inform the Chief Benefits Director Inwriting. Hie Chief Medical Directorshall set forth the rationale for thisconclusion, including an evaluation ofthe claim under the applicable factors ' 'specified in paragraph (e) of this section.

(II) If the Chief Medical Directordetermines there is no reasonablepossibility that the veteran's diseaseresulted from radiation exposure Inservice, the Chief Medical Director shallso inform the Chief Benefits Director inwriting, setting forth the rationale for(his conclusion.

(2) If the Chief Medical Director Isunable to conclude whether it is at leastas likely as not, or that there is noreasonable possibility, the veteran'sdisease resulted from radiation ;exposure in service, the Chief MedicalDirector shall refer the matter to anoutside consultant In accordance withparagraph (d) of this section.

(3) For purposes of paragraph (c)(l) ofthis section, "sound scientific evidence"means observations, findings, or <conclusions which are statisticallysignificant, are capable of replication,and withstand peer review, and "soundmedical evidence" means observations,findings, or conclusions which areconsistent with current medicalknowledge and are so reasonable andlogical as to serve as the basis ofmanagement offl medical condition.

(d) ReferralVutside consultants. (1). Referrals pursuant to paragraph (c) ofthis section shall be to consultantssplrcted by the Chief Medical Directorfrom outside the VA, upon the ' •recommendation of the Director of the

National Cancer Institute. Theconsultant will be asked to evaluate theclaim and provide an opinion as to thelikelihood the disease Is a result ofexposure as claimed.

(2) The request for opinion shall be Inwriting and shall include a descriptionof:

(I) The disease, Including the specificcell type and stage, If known, and whenthe disease first became manifest;

(II) The circumstances, Including date,of the veteran's exposure;

(Hi) The veteran's age, gender, andpertinent family history;

(Iv) The veteran's history of exposureto known carcinogens, occupational^ orotherwise;

(v) Evidenc'e of any other effectsradiation exposure may have had on theveteran; and

(vl) Any other Information relevant todetermination of causation of theveteran's disease.

The Chief Medical Director shallforward, with the request, copies ofpertinent medical records and, whereavailable, dose assessments fromofficial sources, from credible sources asdefined in paragraph (a)(0)(ii) of thissection, and from an independent expertpursuant to paragraph (a)(3) of thissection.

(3) The consultant shall evaluate theclaim under (he factors specified in ,paragraph (e) of this section andrespond in writing, stating whether it laeither likely, unlikely, or approximatelyas likely as not the veteran's diseaseresulted from exposure to ionizingradiation in service. The response shallset forth the rationale for theconsultant's conclusion. Including theconsultant's evaluation under theapplicable factors specified inparagraph (e) of this section. The ChiefMedical Director shall review theconsultant's response and transmit Itwith any comments to the Chief BenefitsDirector for use in adjudication of the •claim. •

(e) Factors for consideration. Factorsto be considered In determining whethera veteran's disease resulted fromexposure to ionizing radiation in serviceInclude:

(1) The probable dose, In terms ofdose type, rate and duration as a factorIn inducing the disease, taking intoaccount any known limitations in thedosimetry devices employed in Itsmeasurement or the methodologiesemployed in its estimation;

(2) The relative sensitivity of theInvolved tissue to induction, by ionizingradiation, of the specific pathology;

(3) The veteran's gender and pertinentfamily history;

(4) The veteran's age at time ofexposure;

(5) The time-lapse between exposureand onset of the disease; and

(0) The extent to which exposure toradiation, or other carcinogens, outsideof service may have contributed todevelopment of the disease.

(0 Adjudication of claim. Thedetermination of service connection willbe made under the generally applicableprovisions of this part, giving dueconsideration to all evidence of record,Including any evaluation by the ChiefMedical Director or an outsideconsultant, and to the evaluationspublished pursuant to ft1.17 of this title.Notwithstanding any determinationunder paragraph (c)(l) of this section,the Chief Benefits Director may requestthat the Chief Medical Director refer anyclaim to an outside consultant. Withregard to any issue material toconsideration of a claim, the provisionsof | 3.102 of this title apply.

(g) Willful misconduct and •supervening cause. In no case willservice connection be established if thedisease is due to the veteran's ownwillful misconduct, or if there isaffirmative evidence to establish that asupervening, nonservice-relatedcondition or event is more likely thecause of the disease.

(h) Service connection othenviseestablished. Nothing in this section willbe construed to prevent theestablishment of service connection forany Injury or disease otherwise shownby sound scientific or medical evidenceto have been Incurred or aggravated as• result of active service.(Pub. L 86-842} ,

f 3.113 Interim benefit* for disability ordeath due to ehloraent or porphyriaeutariM tartfa.

(a) Disability benefits. Except asprovided in paragraph (c) of this section,a veteran who served in the activemilitary, naval or air service in theRepublic of Vietnam during the Vietnamera, and who suffers from chlorecne ofporphyria cutanea tarda which becamemanifest within one year after the date .of the veteran's most recent departurefrom the Republic of Vietnam duringsuch service, shall be paid interimdisability benefits under this section Inthe same manner and to the same extentthat compensation would be payable ifsuch disabilities were service-connected.

(b) Death benefits. Except as providedIn paragraph (c) of this section, if aveteran described in paragraph (a) ofthis section dies as a result of chloracneor porphyria cutanea tarda, the

Federal Register / Vol. 50, No. 77 / Monday, April 22, 1985 / Proposed Rules 1505x1

veteran's survivors shnll be paid interimdeath benefits under this section basedupon the some eligibility requirementsnnd af the snme rates Ihnt dependencyand indemnity compensation would bepayable if the death were service-connected.

(c) F.icrptmns. Benefits under thissection are not payable for any monthfor whirh compensation or dependencyand indemnity compensation is payablefor the snme disability or death, nor arebenefits payable under this section (1Jwhen there is affirmative evidence thaiIhe disease was not incurred by theveteran during service in the Republic ofVietnam during the Vietnam era, (2)when there is affirmative evidence lo

establish that an intercuirent injury ordisease, which is a recognized cause ofthe disease for which benefits are beingclaimed, was suffered by the veteranbetween Ihe dale of the veteran's mostrecent departure from the Republic ofVietnam during active military, naval orair service and the onset of the claimeddisease, or (3) if it is determined, basedon evidence in Ihe veteran's servicerecords and other records provided bythe Secretary of Defense, that theveteran was not exposed to dioxinduring active military, naval or airservice in the Republic of Vietnamduring the Vietnam era.

(d) Similarity to service-connectedbenefits. For purposes of all laws

administered by the VA (exceptchapters 11 and 13 of Title 38, UnitedSlates Code), a disease establishingeligibility for disability or death benefitsunder this section shall be treated as if itwere service-connected, and the receiptof disability or death benefits shall betreated as if such benefits werecompensation or dependency andindemnity compensation, respectively.

(e) Effective dales. Benefits under thissection may not be paid for any periodprior to October 1,1964, nor for anyperiod after September 30, I960.(Pub. L 98-5*2) (Ocl. 1.1084)

|FR Doc. 85-9743 Filed 4-19-65: 8:45 am)•tUJNO CODE MW-el-M

VETERANS' ADVISORY COMMITTEE ON ENVIRONMENTAL HAZARDS

Dioxin Experts

George D. Lathrop, M.D., Ph.D., JRB Associates, San Antonio, TexasDr. Lathrop received his medical degree from the University ofIllinois in 1962 and his doctorate in epidemiology from theUniversity of California at Berkley in 1968. Formerly the Chief,Epidemiology Division, United States Air Force School of AerospaceMedicine, Dr. Lathrop was the chief investigator for the Air Force"Ranch Hand" study. He is a Fellow of the American College ofPreventive Medicine and is certified by the American Board ofPreventive Medicine. He is a member of several professionalorganizations, including the American Public Health Association andthe Texas Society of Infectious Diseases.

Walter Melvin, M.D., Professor of Environmental Health Sciences,Colorado State University, Fort Collins, ColoradoDr. Melvin received his medical degree from the University ofColorado in 1949, a Master of Public Health degree in industrialhygiene from the Harvard University School of Public Health, and aDoctor of Science degree in Environmental Toxicology andOccupational Health from the University of Cincinnati in 1962. Heis a founding member of the American College of Toxicology, a Fellowin the American Public Health Association, and a member of a numberof other professional associations.

James S. Taylor, M.D., Department of Dermatology, Cleveland ClinicFoundation, Cleveland, OhioDr. Taylor received his medical degree in 1966 from IndianaUniversity and is certified by the American Board of Dermatology.He currently is the head of the section on Industrial Dermatology atthe Cleveland Clinic, a post he has held since 1973, and has writtenseveral publications on chloracne.

Radiation Experts

James V. Neel, M.D., Ph.D., Professor of Genetics, University ofMichigan Medical School, Ann Arbor, MichiganDr. Neel received his doctorate in genetics in 1939 and his medicaldegree in 1944, both from the University of Rochester. He served onthe National Research Council's Atomic Bomb Casualty Commission.His membership in professional organizations includes the NationalAcademy of Sciences, the Association of American Physicians, theAmerican Philosophical Society, and the American Society ofNaturalists. His principal professional interest is in the area ofthe genetics of man. He as had extensive experience in the area ofthe genetic effects of radiation.

2.

Arthur C. Upton, M.D., Institute of Environmental Medicine, New YorkUniversity Medical Center, New York, New YorkDr. Upton received his medical degree from the University ofMichigan in 1946 and is certified by the American Board ofPathology. He has had extensive experience in the area of theeffects of radiation exposure with particular interest in thepathology of radiation injury and endocrine glands, cancer,carcinogenesis, experimental leukemia, and aging. He was recentlythe Director of the National Cancer Institute.

Edward W. Webster, Ph.D., Department of Radiology, MassachusettsGeneral Hospital, Boston, MassachusettsDr. Webster received his doctorate in electrical engineering fromthe University of London in 1946. His particular areas of interestare radiological physics, including radiation dosimetry andprotection, in which he is certified by the American Board ofRadiology. He is a member of a number of professional associations,including the American Association of Physicists in Medicine, theHealth Physics Society and the Society of Nuclear Medicine.

Generalists

Michael Bender, Ph.D., Brookhaven National Laboratory, Upton, NewYork.Dr. Bender received his doctorate in biology from the Johns HopkinsUniversity in 1956. He has had experience in the field of radiationand genetics. He is a member of several professional societies,including the American Society for Cell Biology, the RadiationResearch Society arid the Environmental Mutagen Society.

Theodore Colton, Sc.D., Professor of Public Health, BostonUniversity School of Public Health, Boston, MassachusettsDr. Colton received his doctorate from the Johns Hopkins Universityin 1960. He has had extensive experience in the field ofbiostatistics and epidemiology. The professional organizations towhich he belongs include the Society for Epidemiological Research,the American Public Health Association, and the Biometrics Society.He is a Fellow of the American Statistical Association.

Leonard T. Kurland, M.D., Dr. P.H., M.P.H., Chairman, Department ofMedical Statistics and Epidemiology, Mayo Clinic, Rochester,MinnesotaDr. Kurland received his medical degree from the University ofMaryland in 1945, his master's degree in public health from HarvardUniversity in 1948 and his doctorate in public health from the JohnsHopkins University in 1951. He is certified by the American Boardof Preventive Medicine. Among his professional interests is theepidemiology of chronic disease. He is a member of the AmericanEpidemiological Society.

3.

Warren K. Sinclair, Ph.D., President, National Council on RadiationProtection and Measurements, Bethesda, MarylandDr. Sinclair received his doctorate in physics from the Universityof London in 1950. His professional interest is in the areas ofradiation protection, radiation physics, and radiation biology. Hismembership in professional organizations includes the RadiationResearch Society, the Society of Nuclear Medicine, and theAssociation of Physicists in Medicine.

Armori F. Yanders, Ph.D., Professor of Biological Sciences andDirector, Environmental Trace Substances Research Center, Universityof Missouri, Columbia, MissouriDr. Yanders received his doctorate in zoology from the University ofNebraska in 1953. A geneticist and former Dean of the College ofArts and Sciences of the University of Missouri at Columbia, he is amember of the American Society of Zoologists, and the GeneticsSociety of America. His research has involved the genetic effectsof ionizing radiation and toxic chemicals.

Lay Members

Oliver Meadows, Godley, TexasMr. Meadows is a former National Commander of the Disabled AmericanVeterans and former staff director of the House of Representatives'Veterans' Affairs Committee. A disabled veteran of World War II, hecurrrently serves on the Administrator's Educational AssistanceAdvisory Committee.

Gerald C. Bender, Jr., Minneapolis, MinnesotaMr. Bender served in combat in Vietnam and is a disabled veteran.Trained as a lawyer, he currently is the Director of the AgentOrange Information and Assistance Program for the MinnesotaDepartment of Veterans' Affairs.

Hon. Michael Zimmerman, Supreme Court of Utah, Salt Lake City, UtahJustice Zimmerman was recently appointed to the Supreme Court ofUtah. As the Governor of Utah's former representative on theDepartment of Energy's Offsite Dose Assessment Advisory Committee,he has a demonstrated interest in the issue of radiation-inducedillnesses.

Col. Eileen Bonner, Washington, D.C.Col. Bonner is the current president of the Reserve officers'Association. A registered nurse, she is a doctoral candidate atColumbia University and a health care administrator.

CENTERS FOR DISEASE CONTROL

CENTLR FDR ENVIRONMENTAL HEALTH - AGENT ORANGE PROJECTS

1600 Clifton Road, N. E., Atlanta, Georgia 30333 (404)454-4472

Project Description for;

EPIDOTOLQGIC STUDY OF THE HEALTH OF VIETNAM VETERANSThe study includes the following three components:1) Agent Orange Study. (Study of the long-term health

effects of exposure to herbicides in Vietnam.)2) Vietnam Experience Study. (Study of the long-term

health effects of military service in Vietnam.)3) Selected Cancers Study. (Study to determine the

risks of specific cancers among Vietnam veterans.)

BACKGROUND! Between August 1965 and February 1971 approximately 11.3 million gallons of theherbicide "Agent Orange" (so named because of the orange markings on the drums in which it wasshipped) were sprayed over much of South Vietnam in military operations designed to deprive theenemy of cover and food. A chemical contaminant, 2,3,7,8-tetrachlorodibenzo-p_-dioxin, more oftencalled TCDD, or simply dioxin, was created during manufacture of and contained in the Agent Orangewhich was sprayed. Dioxin has been shown to be a highly toxic substance.

In January 1978 the Veterans' Administration (VA) received the first of what was to become manyclaims from veterans uho felt that their current health problems had resulted from their beingexposed to Agent Orange while serving in Vietnam. In January 1979 the U.S. Congress enactedlegislation (Public Law 96-151) directing the VA to design and conduct an epidemiologic study todetermine if exposure to Agent Orange had caused long-term adverse health effects in Vietnamveterans. In November 1981 the scope of the study was expanded (by Public Law 97-72) to includeother factors in the "Vietnam experience," including medications and environmental hazards orconditions.

In January 1983 the responsibility for designing and conducting the investigation was transferredfrom the VA to the Centers for Disease Control (CDC). In flay 1983 CDC scientists completeddetailed guidelines (protocols) for the Agent Orange and Vietnam Experience studies, recommendingthat a third investigation be conducted at the same time to determine the risk of Vietnam veteransdeveloping selected types of cancers.

Public "Notice of Research Project Initiation" was published in the Federal Register on flarch 13,1984.

DESCRIPTION; AGENT ORANGE AND VIETNAM EXPERIENCE STUDIES. Although both of these historical, or"retrospective,"studiesare insomerespectssimilar, each has a separate purpose. The AgentOrange study is designed to find out if troops who were exposed to the herbicide during service inVietnam have suffered long-term adverse health effects as a result of that exposure. The VietnamExperience study is designed to demonstrate whether or not there is any difference in the health ofveterans of the Vietnam era who served in Vietnam compared to the health of veterans who served inother countries during the same period of time.

The studies require the cooperation of a large number of Vietnam era veterans willing to beinterviewed about their health status and experiences before, during, and after those years. Withthe help of the Department of Defense and other agencies, CDC will identify 30,000 qualifiedveterans to participate in the studies: 6,000 in each of five separate, specially defined groups or"cohorts." The five cohorts are to be made up of veterans who:

1) Served during 1967-68 in a specified area of Vietnam, andwere likely to have been exposed to Agent Orange.

2) Served during 1967-68 in the same area of Vietnam ascohort 1, and were less likely to have been exposed to AgentOrange.

3) Served during 1967-68 in another area of Vietnam thancohorts 1 and 2, and were not likely to have beenexposed to Agent Orange.

4) Served in Vietnam during 1966-71. Randomly selectedfrom all areas.

5) Served during 1966-71 in countries other than Vietnam.

Data for the Agent Orange investigation will be gathered from cohorts 1, 2, and 3. Cohorts 4 and 5will provide data for the Vietnam Experience study.

The interview takes about 45 minutes and will be conducted by telephone. After being interviewed,as many as 2,000 veterans from each cohort will be randomly selected and asked to takecomprehensive medical examinations which will take three days to complete. To ensure that standardtesting procedures are used, these 10,000 examinations will be conducted at one location:.Albuquerque, New Mexico. Veterans' expenses for travel and lodging, etc., will be paid by thegovernment. A stipent ($300) will be paid to each veteran who completes the medical examination.

Veteran interviews in connection with the CDC study began in September, 1984, and will continueuntil about October, 1987. The medical examinations will be conducted from March, 1985, untilabout January, 1988.

To ensure statistical accuracy, no volunteers can be included as participants .in the studies.Participants will be randomly selected.

To determine whether and to what degree their experiences have affected the health of veterans inthe five cohorts, CDC researchers will use computers and complex mathematical analyses to comparethe millions of data collected during the study. Non-government research firms, under carefulscientific and managerial surveillance by CDC officials, have been contracted to collect some ofthese data. All personal information collected during the study will be held in completeconfidence. Physicians and other health providers working on the CDC studies will not provide anytreatment for individuals. If a veteran's medical examination indicates the possible existence ofa problem of any sort, the veteran will be advised immediately and encouraged to seek treatmentfrom the VA, private, or other sources of medical services.

DESCRIPTION; SELECTED CANCERS STUDY. There is some scientific evidence that exposure toherbicidesmayincreasetheriskof several serious, but relatively rare, cancers in workers inindustries which manufacture or use similar products. Because these cancers are so infrequentlyseen, the 30,000 veterans in the other study cohorts do not offer a large enough sample populationupon which to base this investigation. Instead, two other groups will be studied in a"case-control" investigation. The first (case) group will be made up of male patients who haveactually had these tumors, and who could have been in the military during the Vietnam conflict.The second (control) group will include men of the same age and from the same current geographicarea as the case cohort, but without the tumors.

INVESTIGATION RESULTS; The exact rate of progress of epidemiological studies of this size cannotElforecast.Collection and analysis of the large amounts of data needed for scientifically validfindings takes time; particularly when so many thousands of veterans must be identified, located,interviewed, and examined. CDC will report on each component of the study when it has beencompleted. Final reports on the Agent Orange and Vietnam Experience components are expected bySeptember 30, 1988. The final report on the Selected Cancers Study component is expected bySeptember 30, 1989.

CDC hopes that these studies will provide answers to many of the important questions being askedabout Agent Orange and other factors related to service in Vietnam. But, as in every epidemiologicinvestigation—no matter how carefully designed and professionally conducted—the possibilityexists that definitive answers to some questions may never be found.

2/7/85

AGENT ORANGE EXPOSURE

The claims of a number of veterans who have alleged disabilities due to Agent

Orange have been denied because of the lack of evidence showing the existence of

a disability attributable to exposure to that chemical. As claims are encoun-

tered in which the veteran is claiming exposure to Agent Orange, the information

pertaining to availability of hospital examination and treatment is furnished to

the veteran.

In those instances where the veteran alleges Agent Orange exposure only, all

available service clinical and treatment records are obtained and reviewed by

the rating board for any indication of service-connectable disability.

Consistent with our reasonable doubt policy, given the considerable uncer-

tainties as to the deposition of defoliants in Southeast Asia and troop posi-

tions at pertinent times, we accept, in absence of affirmative evidence to the

contrary, a Vietnam veteran's contention of exposure.

A register of Agent Orange claims is being maintained by the VA while studies

are being accomplished in the area of Agent Orange.

AGENT ORANGE CLAIMS

April 1, 1985

A. Total Number of Claims

Claims with Diagnosis ConfirmedClaims with Diagnosis not ConfirmedClaims with No Disability Alleged

B. Claims with Diagnosis Confirmed

Allowed for Reason Other than AgentOrange

"Denied

NUMBER

24174

11697€1196358

11697

2049*9648a

PERCENT

100.0%

48 .4%25.3%26.3%

100.0%

17.8%82.8%

a. These 9648 claims having more than one claimed diagnosis fallinto the following categories:

Skin condition (acne, alopecia, eczema,keloids and urticaria)

Nervousness, headaches andfatigue (claimed)

Paralysis or numbness and othersymptoms of extremities

GI and GU conditionsMalignancies (leukemia, lymphoma,melanoma, Hodgkin's, etc)

Impaired sexual activity (alleged)EENT pathologyLung conditionCardiovascular and hypertensionMisc.

5373

2562

966890854

341481332290162

* Approximately 96.5% or 1981 of the total 2049 claims allowedare service connected for skin condition. Balance of 3.3% or 68claims were allowed for cancer, psychiatric and neurologicalconditions and various other miscellaneous disabilities.

IONIZING RADIATION EXPOSURE

Approximately 203,000 veterans participated in atomic tests since Operation

Crossroads in Bikini Atoll in 1946. Claims have been received from approxima-

tely 4,800 of these veterans alleging exposure to radiation from atmospheric

tests, from participating in the clean-up operations in Hiroshima and Nagasaki,

from occupational exposure while working with radiation material, and from

therapeutic exposure such as x-ray therapy received during treatment.

The best available evidence indicates that the average radiation doses received

by veterans from weapons testing and by veterans of the occupation of Hiroshima

and Nagasaki were very low. Further, there is little solid scientific evidence

to support a causal connection between exposure of the levels involved here and

the subsequent development of illnesses.

Over the years, we have received 955 claims in which leukemia and other

malignancies have been claimed to be due to exposure received during atmospheric

tests. Host claims which have been allowed are for leukemia and other

malignancies. To date, no claims have been allowed based on exposure received

while participating in the occupation of Hiroshima and Nagasaki.

In evaluating claims for radiation injury or disease, the policy of the VA is

that service connection may be established for either the immediate or delayed

direct results of ionizing radiation. Our review of diseases or injuries

resulting from radiation has always followed detailed development of the facts

and circumstances surrounding the exposure unique to each claim. In each claim,

we consider the medical characteristics of the disease and the relationship in

time between exposure and onset of the disease. We also consider the type,

duration and cumulative amount of radiation exposure before arriving at a

decision. It has, however, always been our policy that service connection

may be established without regard to the length of time between exposure and

disease where the disease or injury is directly traceable to the effects of

radiation during military service.

Our liberal approach of resolving all reasonable doubt in favor of the veteran

has permitted allowance of a number of cancer claims filed on behalf of former

nuclear weapons tests participants, even though their recorded radiation doses

were very low and their diseases first appeared many years after service.

When called upon by the VA, the Defense Nuclear Agency will verify the veteran's

participation in an A-test and the correctness of film badge readings based

upon the individual's activities at each test in which he or she participated.

In those instances where there is no record of a film badge reading for an

individual, a reconstruction of the extent of his or her exposure together

with the highest likely amount of radiation to which the individual may have

been exposed while at the test will be furnished.

Under the law, Public Law 97-72, the hospital and medical treatment program of

the Veterans Administration is available to all veterans who may be suffering

from disease or injury resulting from ionizing radiation. Upon application, the

hospital authorities will schedule the veteran for an examination and a pro-

fessional determination will be made for his or her care. Our hospitals can and

do provide the type of care required by the veteran's disability in accordance

with his eligibility and entitlement.

Since we maintain a record of all claims for disability allegedly resulting from

exposure to ionizing radiation, we are able to reconsider each claim for compen-

sation benefits upon receipt of new and material evidence from any source.

3.

Also, if the results of any of the ongoing epidemiological studies impel a

change in our regulations or in the law, those individuals may be assured that

their claims will be reviewed under such changes upon the initiative of the VA.

The Hiroshima-Nagasaki study is the only full statistical study on genetic

damage in children born of survivors of the nuclear bombings of those cities.

The study of the effects of long-term low-level exposure on offsprings is being

carried on in the continuation of that study. This is being done by including

recently born children of A-bomb survivors in the study and examining them at

appropriate intervals; and, to date no evidence has been found of genetic

malformation.

April 1,

RADIATION EXPOSURE CLAIMS

NUMBER

1985

A. Total Number of Cases in Study

Cases with DiagnosisCases no Diagnosis

B. Cases with Diagnosis

AllowedDenied

C. Total Cases in Study

Claimed A-TestClaimed Other Exposure

D. Those Who Claimed A-Test

AllowedDeniedNo Diagnosis

E. Those Who Claimed Other Exposure

AllowedDeniedNo Diagnosis

4839

30001839

3000

78.2922

4839

28641975

2864

151811*1038

1975**

631086626

PERCENT

100.0%

62.0%38.0%

100.0%

2.6%97.4%

100.0%

59.2%40.8%

100.0%

0.5%63.2%36.2%

100.0%

3.2%55.0%41.8%

IN SUMMARY

Total Cases

AllowedDeniedNo Diagnosis

4839

7828971864

100.0%

1.6%59.9%38.5%

* These 1811 claims have the following 1076 malignant diagnosis:

Histiocytic leukemia - 2 Blood condition - 5 Endocrine cancer - 33Myelocytic leukemia - 29 Lymphocytic lymphoma - 35 Skin cancer -Hairy cell leukemia - 7 Hodgkin's disease - 17 Brain tumor -Unspecified leukemia- 37 Respiratory cancer - 280Lymphocytic leukemia- 29 G.U. Cancer -Myelogneous leukemia- 20 G.I. Cancer -

Melanoma -135 Cancer, musculo-178 skeletal -

** These 1975 claims contain 735 Nagasaki and Hiroshima claimsconsisting of leukemia and other malignancies 334; Misc. 251 andexposure only 150. None allowed.

1514227

49

Vw^ Veterans Administration

REFERENCE SUPTO (Name or title-Mail routing symbol)

1.

Alvin L. Young, Ph.D.z.

Senior Policy Analyst for3.

Life Sciences, OSTP4.

Washinqton, D.C. 20506s.

INITIALS-DATE

REASON FOR REFERENCE

[ J AS REQUESTED I I FOR YOUR FILES | | NOTE AND RETURN

LJ COMMENTS 1 1 INFORMATION LJ PER CONVERSATION

I 1 CONCURRENCE I (NECESSARY ACTION 1 (SIGNATURE

SUBJ: Agenda for 4/22-23/85 AdvisoryCommittee on EnvironmentalHazards Meeting

The attached agenda is forwarded

for your information.

Att.

FREDERIC L. CONW#Y III (02C)Special Assistant tothe General Counsel

DATE

4/8/85TEL. EXT.

3723VA FORMMAY 19SD

EXISTING STOCKS OF VA FORM 3230.AUO 1976, WILL BE USED.

„ - _ „ n . „ „ „U.S. G.P.O. 1984-709-228

AGENDA

VETERANS' ADVISORY COMMITTEEON ENVIRONMENTAL HAZARDS

April 22, 1985

9:30 Opening Comments Chair

9:40 Welcome Harry WaltersAdministrator of Veterans' Affairs

Donald IversGeneral Counsel

Dr. John Di tzlerChief Medical Director

John HaganActing Chief Benefits Director

10:00 Introductions Frederic L. ConwayExecutive Secretary

10:10 Committee Organization Chairman

10:30 V A 1 s DisabilityCompensation Program Gerald Moore, Director,

Compensation and Pension Service

10:45 Public Law 98-542 John ThompsonDeputy Assistant General Counsel

11:15 Discussion

11:30 Lunch (on own)

April 22, 1985 (cont.)

1:00 Agent Orange Overview Alvin Young, Lt. Col. USAF, Ph.D.Senior Policy Analyst for LifeSciences, Executive Off,, ice of thePresident

2:15 Break

2:30 Cabinet Council AgentOrange Working Group Carl Keller, Ph.D, D.V.M.

Chair, Science Panel

2:45 VA's Agent Orange Program..Dr. Bare],ay ShepardDirector, Agent Orange ProjectsOffice

3:15 General Discussion

4:00 Adjournment

A p r i l 23, 1985

9:30 Atomic Weapons Testingand Hiroshima andNagasaki, JapanExposure... ...Defense Nuclear Agency

10:30 Discussion

11:15 VA's actions regardingradiation exposure ....Dr. James Smith, Director,

Nuclear Medicine Service

11:30 Lunch (on own)

1:00 Committee on InteragencyRadiation Research andPolicy Coordination... Dr. Young

1:15 Proposed Regulations.. John Thompsont.

2:00 Break

2:15 General Discussion

3:00 Concluding Remarks Chairman

3:30 Adjournment