Document G5wZ9ebDba9eNpb0ZJJvj1kXV

Monsanto Monsanto Company 800 N. Lindbargh Boulevard St. Louis, Missouri 63167 Phone: (314) 694-1000 August 20, 1985 DEPARTMENT OF MEDICINE A ENVIRONMENTAL HEALTH Daniel Hryhorczuk, M.D. NORTHWESTERN MEDICAL FACULTY FOUNDATIONS, INC. 222 East Superior Street Chicago, Illinois 60611 Dear Dr. Hryhorczuk: Enclosed is a copy of a Federal Register article dealing with the V.A. and Dioxin and Ionizing Radiation. In case you haven't seen it, it accepts only chloracne. It acknowledges that P.C.T. and soft tissue sarcomas have been hypothesized, but goes on to state that "sound medical and scientific evidence does not support a causal association between dioxin exposure and the development of P.C.T." and also "dioxin has not been shown to be a human carcinogen". It seems to me that the last hypothesis is certainly implied if not specifically stated in our W.G. Xrummrich study and it remains to be seen whether we will reconfirm it or come up with a new relationship. The question of P.C.T. has been discussed and urinary porphyrins are being considered, but we have to talk more about what we plan to do in the study. Sincerely, cc: George Roush, M.D mes H. Spraul, M.D. 1AB/55 082085 DSW 476038.0770 STLCOPCB4042934 \/.A, 3 15848 Fodorml Register / Vol. 80. No. 77 / Monday. April 22. 198S / Proposed Rules VETERANS ADMINISTRATION 38 CFR Parts 1 and 3 Adjudteetlon of Claims Beeed on Exposure to Dioxin or lonixing Radiation * AGENCY: Veterans Administration. action: Proposed rules. SUHMARV: The Veterans Administration (VA) proposes the following regulations to implement the "Veterans Dioxin and Radiation Exposure Compensation Standards Act." PubTL 98-542 (Oct 24. TSSJJTTTIe'Act requires that the VA conduct rulemaking regarding its guidelines for the adjudication of compensation claims based upon disabilities or deaths of certain veterans who. while in military service, were exposed to ionizing radiation or herbicides containing dioxin. The stated purpose of the Act is to ensure compensation for "veterans who were exposed during service in the Armed Forces in the Republic or Vietnam to a herbicide containing dioxin or to ionizing radiation in connection with atmospheric nuclear tests or in connection with the American occupation of Hiroshima or Nagasaki, Japan, for all disabilities arising after that service that are connected, based on sound scientific and medical evidence, to such service." dates: Comments must be received an or before July 22,1985. It is proposed to make these rules effective thirty days after date of publication of the final rules with the exception of { 3-B13 which is proposed to be effective October 1. 1984, as required by law. - addresses: Interested persons are invited to submit written comments, suggestions, or objections regarding these rules to Administrator of Veterans Affairs (271A). Veterans Administration, 810 Vermont Avenue, NW., Washington. DC 20420. All written comments received will be available for public inspection only at the Veterans Services Unit, room 132, at the above address only between the hours of 8 a.m. and 4:30 p.m. Monday through Friday (except holidays) until August 5,1985. FOR FURTHER INFORSIATION CONTACT: Robert M. White. Chief. Regulations Staff. Compensation and Pension Service. Department of Veterans Benefits (202) 389-3005. SUPPLEMENTARY INFORMATION: The VA administers compensation programs for veterans disabled as a result of injuries or diseases incurred or aggravated during yiilitary service, and for survivors of veterans whose deaths result from such service coenectsd causes. Monthly benefits era paid at statutory rales which vary with the level of disability or, for survivors, with the military pay grade of the deceased. Nearly two aad one-quarter million veterans and 400,000 survivors are currently receiving these 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, to ionizing radiation or dioxin. Under Pub. L 98-542. VA is to set forth, for pabhc comment, "guidelines and (where appropriate) standards and criteria" for its resolution of two categories of such claims: those based on exposure to herbicides containing dioxin (e^ "Agent Orange"! during service to the Republic of Vietnam, and those based on exposure To ionizing radiation in - connection with participation in the atmospheric testing of nuclear weapons or the American occupation of Hiroshima or Nagasaki, Japan, at the close of World War II. Section 5 of the new law specifies that regulations be issued to guide VA adjudication personnel in deciding the merits of these claims. The regulations are to ensure continuation of VA's current policy of granting claimants die benefit of the doubt when there is an approximate balance of positive and negative evidence regarding any material issue. The regulations are also to cany forward current policy af denying claims if the evidence makes dear that disability or death was caused by some poet-service occurrence or resulted from the veteran's own willful misconduct . These rules are to specify whedwr, and if so under what circumstances, certain diseases are to be recognized as connected to a veteran's exposure. The rules are to be srounHgH in "TM--i scientific and medical evidence ** With respect to Vietnam veterans exposed to heroiciaes containing dioxin, the diseases" tor which rules must be issued arepWpracnel borptivria cutanea tsrda.1 anaTsoft tissue sarcoma! For veterans exposed to ionizing radiation under the specified conditions, the diseases for which rules must be issued are leukemias, 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 baaed upon other diseases for which the Administrator finds there is soand scientific or medical evidence indicating a connection with such exposures. In additioa the VA is to publish guidelines for its evaluation of sTnriirs into the health effects of exposw to inoiring radiation or herbicides containing dioxin, and give notice of these evaluations by publication in the Federal Register. Section 8 of the Act authorizes a new "Veterans' Advisory Committee on Environmental Hazards." The 15nwmber committee, composed of an 11member Scientific Council and 4 lay members, will formally consider these proposed regulations and may recommend changes before final rules are published. The panels of the Scientific Council are also responsible far advising the Administrator as to additional diseases to be covered by the regulations and respecting the study inrahmtinri discussed above. Finally, these regulations implement Section 9 of the Act. which authorizes "interim benefits" for certain Vietnam veterans. Section 1.17 Study evaluations. This section, to be added to Part 1 of 38 CFR Chapter I. relating to General Provisions, provides a formal process for the Agency's evaluations of scientific and medical studies relating to the possible adverse health effects of dioxin or radiation exposure. As contemplated by section 5(b) of the Act the evaluations would be published from time to time in the "Notices" section of the Federal Register. In addition to statutory criteria--whether the findings are statistically significant have withstood peer review, and are capable of replication--these evaluations would outsider the views of the appropriate panel of the Scientific Council of the Advisory Committee and the jpiifii linn 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 sample, e.g.. laboratory experiment, an opinion poll, or an extensive "head coant," to the relevant population. Tests for statistical significance estimate the chance that the investigation's results would have been achieved if the population had particular characteristics. The desired numerical value for statistical significance varies depending upon the information sought and how certain the scientists want to be that the results are not due to chance. Selection of theae values depends upon the judgment of expert, qualified scientists, but in the absence of compelling evidence is based upon conventionally accepted numerical values. "Peer review" is an accepted means of assuring scientific quality. It ordinarily DSW 476038.0771 STLCOPCB4042935 Federal Register / Vol. 50. No. 77 / Monday. April 22. 1965 / Proposed Rules 15849 1 is performed by a group of a scientist's superiors or peers who review the research when it is completed to determine whether it has been properly conducted and whether the conclusions drawn are justified by the results obtained. Ordinarily the review groups are constituted within the scientist's organization, whether academic, governmental or private, often with participation by outside experts. Section 3.102 Reasonable doubt policy. This section of Part 3. Adjudication, is reworded and simplified. Since the 1920's. the purpose of the "reasonable doubt policy" has been to assure the resolution of close issues, material to the claim, in the claimant's favor whenever it is not unreasonable to do so. Decisions on material issues--usually, issues that must be resolved in the claimant's favor if the benefit is to be granted--are made only after all available evidence has been assembled. If the evidence of record supports the claim and is adequately probative, there is no need for the application of the reasonable doubt policy. Conversely, if the evidence is insufficient to support the claim, the policy should not be applied. Entitlement should never be based on speculation or remote possibility. It sometimes happens, however, tHat the evidence supporting the claim is counterbalanced by other evidence that creates a reasonable doubt as to the claim's merits. In this type of situation, the reasonable doubt is to be resolved in the claimant's favor. Section 5(a)(2) of the Act directs the Agency to assure that this policy, reformulated in section 2(13) of the Act applies to dioxin and radiation exposure claims. Proposed new || 3.311a and f 3.311b (below) accordingly refer to S 3.102. To avoid possible confusion from alternative formulations, this regulatory proposal would realign the text of i 3.102 in accordance with the congressional reformulation. No substantive alteration of the "reasonable doubt" policy is intended. Section 3.311a Dioxin rule. This section, to be added to 38 CFR Part 3. provides guidelines and criteria for the resolution of veterans' claims based on exposure to a herbicide containing dioxin during military service in the Republic of Vietnam during the Vietnam era. Background. Beginning in the 1940's, phenoxy herbicides were widely used in the United States and elsewhere by farmers, foresters, and homeowners. Herbicides were used during the Vietnam conflict to defoliate trees, remove ground cover, and destroy crops. Shipped in orange-striped barrels. Agent Orange was a liquid containing two chemicals, one of which, 2,4,5trichlorophenoxyacetic acid (2,4.5-T). is contaminated during the manufacturing process by 2,3,7,8-tetrachlorodibenzo-pdioxin. also known as TCDD or. more popularity, dioxin. The contaminant dioxin, first identified in the 1960's, is of special concern because studies have shown it to be highly toxic to certain animal species. More than 2.4 million United States military personnel served in Vietnam. Many were deployed in or near locations where Agent Orange was sprayed, and others--particularly the Ranch Hand group--participated in the spraying operations directly. According to The Toxicology, Environmental Fate, and Human Risk of Herbicide Orange and Its Associated Dioxin (USAF Technical Report No. OEHL TR-78-92,1978), about 10.6 million gallons of herbicides were sprayed in Vietnam, with a mean dioxin concentration of about 2 parts per million. During the 7-year period of Agent Orange use, about 3 million acres were sprayed at various times. The mean distribution of dioxin per acre is estimated at 0.00013 pounds (0.06 grams). Dioxin is photo-degradable, that is. it decomposes in sunlight. The soil concentration is estimated at 0.016 parts per billion. There are other sources of human dioxin exposure besides Agent Orange, for example, exposure from industrial accidents, contaminated industrial wastes, farming and ranching herbicide applications, transportation accidents, and hexachloraphene. a germicidal agenfwidelyusedln the 1950's and 1960's. Definitions. The term "dioxin" may refer to one of several chemicals. This section uses dioxin to refer only to 2.3,7.8-tetrachlorodibenzo-p-dioxin. the Agent Orange contaminant. Because some military personnel stationed elsewhere may have been present in the Republic of Vietnam, "service in the Republic of Vietnam" will encompass services elsewhere if the person concerned actually was in the Republic of Vietnam, however briefly. The law requires these regulations to specify the circumstances under which service connection may be established for disability resulting from chloracne, porphyria cutanea tarda (PCT), or soft tissue sarcoma. These rules are to be based on sound scientific'and medical evidence. In this section, "sound scientific evidence" consists of findings that are statisticaUy~slimiftcanL withstand peer review, and are capable of replication. "Sound medical evidence" means studies consonant with medical knowledge and conclusions on which medical treatment could be prudently based. Exposure. In view of shifting personnel deployments, absence of on site measurement of dioxin contamination and other factorsjhe. Agency has adhered to a policy of presuming exposure it the veterans sefvedln Vietnam during the relevant period. This section formalizes that existing policy. Service connection. At the present time, there is sound scientific and medical evidence that chloracne, a skin disorder, can result from dioxin exposure. See, e.e.. Crow. K.D.. Significance of Cutaneous Lesions in the Symptomatology of Exposure to Dioxins and Other Chloracnegens, in Human and Environmental Risks of Chlorinated Dioxins and Related Compounds (Tucker et al., ed.. Plenum Press, 1983). Chloracne may subside spontaneously, but it can be a chronic condition. Industrial accident follow-up studies indicate that chloracne associated with dioxin exposure is manifest within days or weeks. This section provides that a veteran's disabling chloracne may be service conhectedlf the first symptoms appeared within three months of the veteran's departure from the Republic of Vietnam. {WTpnvestigators concerned about the possible deleterious effects of Agent Orange exposure located studies of industrial accidents involving phenoxy chemicals in which some exposed individuals developed porphyria cutanea tarda (PCT). This is a relatively rare liver disorder also found] in certain individuals whohave a history of alcoholism. Further investigations have ( revealed that the PCT manifested in the ' industriariccidents occurred when \ hexachlomhenzene. a known potent \ cause of PCT. See. e g., Pazderova, et au Chronic Intoxication by Chlorinated Hydrocarbons Formed During the Production of Sodium 2.4.5 trichlorophenoxyacetate, 26(9) Prac. Lek. 332 (1974). and jones. R.EL, Chelsky. M., Serrone. D.M.. and Hillman, D.W., A Reassessment of the Evidence Linking Porphyria Cutanea Tarda to 2,3.7,8 tetrachlorodibenzo-p-dioxin (TCDD) Exposure (Submitted to Human Pathology for publication). Sound medical and scientific evidence does not support a causal associationbgiwggl^ ijjoxin expppure and the developmentof Jence. this section does not 'provide a basis for service connection, based on dioxin exposure, of a veteran's disabling PCT. Soft tissue sarcomas_ Malignancies in the sott tissue sarcoma jO/ '*-- DSW 476038.0772 STLCOPCB4042936 category are iihtlwly ram. White moat of these malignalKiaa are of tmknown etiology, prolonged expense to asbestos fibers is known to be a causative factor in the development of mesothelioma, sometimes classified as one of these y sarcomas. Dioxin has not been shown to ^ be a human carcinoaea. studies conducted in Sweden in the 1870's suggest a relationship between exposure to phenoxy herbicides and the subsequent development of soft tissue sarcomas, but studies published elsewhere, including studies in the United States, do not confirm the Swedish studies' hypothesis. See. e.g., Fingerhut et aU An Evaluation of Reports of Dioxin Exposure and Soft Tissue Sarcoma Pathology Among Chemical Workers in the United States, 10 Scand. J. of Work. Environment and Health 290 (1884). and Riihimaki. V,, et ah. Mortality of 2.4-D and 2.43-T Herbicide Applicators in Finland. 8 Scand J. of Work. Environment and Health 37 (19821. At the present timt> sound scientific a53 mentcal evidence 1r.i4J.w^atlora a basis for a caul assooaSon between dioxin 'exposure qnri the rfpuplnnmpnt nf mnlignanrv of the soft tissue sarcoma group. Hence, this section does not provide tor service conneotion. based on dioxin exposure, of disability resulting from these diseases. Exceptions. This section provides that chloracne may not be established as service connected if the disability resulted from the veteran's own willful misconduct or there is a supervening, nonservice-connected cause of the disease. ' Construction. Nothing in this section is to be construed as preventing the establishment of service connection for a disability that had its origin in military service. For example, a veteran suffering from PCT or a soft tissue sarcoma may establish service connection based on direct evidence that it existed in service or. in the case of a sarcoma, based on symptoms to a compensable degree within the one-year statutory presumptive period following discharge from service (see 38 U.S.C. 19301. 312). Evaluations. This section provides for the appropriate use of study evaluations published in the "Notices" section of the Federal Register. Section 3.311b Radiation rule. This section provides guidelines and criteria for the resolution of claims for service connection of disabilities based on exposure to ionizing radiation as a result of participation in the atmospheric testing of nuclear weapons, the occupation of Hiroohima and Nagasaki. Japan, at the dose of World War U. or other service activities. This section would replace existing 19.311. which would be removed. * Background. Radiation exposures over which veterans have expressed greatest concern ere those oocarring during atmospheric nuclear testing and the occupation of Hiroshima aed Nagasaki. From IMS through 1982. the U.S. Atomic Energy Commission conducted some 235 atmospheric tests of nuclear weapons, principally in Nevada and the Padfic Ocean. Approximately 2034)00 American military personnel participated in one or more of these tests.. To address concerns regarding possible health effects to test participants, the Defense Nudear Agency (DNA) established the Nuclear Test Personnel Review (NTPR) program in 1977. Among the objectives of this program are identification of personnel involved in testing and compilation of available information on exposure levels. Extensive dose reconstruction has also been undertaken to calculate doses received by participating units and individuals and as a check on recorded dose information from film badges worn by test participants. Research conducted under the NTPR profpnm indicates over 98 percent of atmospheric nuclear test partidpants reportedly received doses of 5 rem or less. To place this in perspective. 5 rem is the current Federal guideline for allowable annual radiation dose for radiation workers. The bombings of Hiroshima and Nagasaki occurred in early August 1945. The first American occupation forces arrived in the vicarity of the Hiroshima bombing site 80 days after the bombing. Occupation forces arrived in Nagasaki 45 days after the bombing. Military records show that IMHO men were billeted for at least a week during 1945 48 inride the city limits of Hiroshima and Nagasaki. Approximately 110.000 personnel spent at least one day within 10 mites of the city limits. An estimated 350.000 personnel were within 100 miles of Hiroshima and Nagasaki. Substantial knowledge of residual radiation at these locations was derived from on-site surveys conducted shortly aftef the bombing and from extensive scientific reconstructions. Several factors, including the lapse of time between the bombing and the occupation, heavy rains during this period, the high burst altitude of the bombs used, and the brief duty tours of occupation participants combined to minimize exposure levels of the occupation forces. Analyses performed by the DNA indicate the (ugliest radiation dose any occupation force pattidpent could have received was less than one rem. Ionizing radiation. Ionizing radiation is radiation having sufficient energy to free electrons from atoms. The resulting ions are capable of causing damage to human tissues. Ionizing radiation includes both electromagnetic radiation, e.g., gamma rays, and particulate radiation. e.g., alpha particles. Exposure. Shifting personnel deployments, absence of on-site measurement of dioxin contamination and other factors make estimation of the extent of dioxin exposure for a particular veteran extremely difficult. In contrast radiation exposure generally occurred in dearly defined areas on specific occasions, and measures were taken to monitor exposure levels. Thus, a veteran's in-service radiation dose can generally be estimated with relative precision. The proposed regulations define procedures for estimating radiation dose. Procedures for service-connection determinations. Proposed | JJllb is designed to essore fairness to claimants and consistency and accuracy in the adjudication of radiation exposure daims. Procedures governing development of evidence, provisions presuming exposure in the absence of adequate records, use of outride experts and consultants, and reference to application of the reasonable-doubt standard are among the features of the proposed regulation designed to assure fair treatment of ail claimants. Consistency and accuracy will be promoted by specification of minimum standards for extended consideration of define and by dear definition of factors to be considered at each stage. Under proposed | XJllbjb), an initial review ofjfaims bated upon radiation exposure would be made in order to identify claims meriting farther consideration under f 3.31lb{c). The VA believes standards and criteria, i.e.. firm rules of decision, are appropriate in connection with this initial review. Principles governing the disability compensation program preclude establishment of service connection, based upon radiation exposure, unless it can be concluded that exposure occurred as daimed. Further, the VA does not believe a claim merits extended consideration under proposed { 3.31lb unless it involves a disease associated with radiation exposure. Proposed 9 3.311b(b)(2) specifies those diseases which may be considered to result from radiation exposure Finally, the proposed rule specifies that further consideration of arfaim under 9 3.311b is unnecessary if a veteran's disease . DSW 476038.0773 STLCOPCB4042937 Fodanl / Voi. 50. Via 77 f Mnmday, Apti XL IMS / became manifeat tether before or after the period following exposure during which the dteeaan. tf rotated to exposure, would be expected to develop. Under the proposal if these minimum criteria are met further consideration of the claim under proposed 13.311b will be accorded. Proposed (&311b{c)(l) provides that daims meeting the initial review criteria wiM be referred to the Chief Medical Director. Under the proposed regulation, if the Chief Medical Director is convinced sound scientific and medical evidence supports the condusion it is at least as likely as not the veteran's disease resulted from radiation exposure in service, the Chief Medical Director will provide the Chief Benefits Director with a written evaluation supporting this conclusion. If the Chief Medical Director determines there is no reasonable possibility the veteran's disease resulted from such exposure, he will so inform the Chief Benefits Director. For purposes of this section, the same definitions of sound scientific and medical evidence stated in proposed 13.311a, pertaining to dioxin exposure, would apply. fat making determinations under proposed S 3.31lb(c). the Chief Medical Director would consider the factors spedfied in proposed { 3.311b(e). These factors are intended as guidelines, or guidance to the decisionmaker, rather than standards or criteria. The VA considers proper claims resolution to require a balancing of these factors on a case-by-case basis. The factors specified are generally recognized in the medical and scientific literature aa inflnenrmg the likelihood that a specifir type of cancer is radiation induced. See. eg.. Committee on the Biological Effects^ Ionizing Radiations. The Effects on Populations of Exposure to Low Levels of Ionizing Radiation: tSOO (BEIR ill report). However, at present, the relative weight of these factors is not susceptible to precise definition. Proposed f 3.311b(c)(2) provides for referral of a ciaim to a oooaultant outside the VA when the Chief Medical Director is unable to determine whether it is at least as likely as not. or that there is no reasonable possibility, the veteran's disease is due to radiation exposure in sorrica. Under proposed S 3.311b(d), (he Chief Medical Director would select the consultant after receiving the recommendation of the Director of the National Cancer Institute. The Chief Medical Director would ask the consultant to evaluate the claim using the lactore specified in proposed I 3.31lb(e) and provide an opinion as to whether it is liltsiy. unlikely, or approximately m Mealy as not the veteran's dteasee ranted from exposure to radiation fa) service. Die consultant's opinion would provide valuable evidence far ronsirteralinu by the Agency. In all cases, the VA'a Department of Veterans Benefits would adjudicate the daim under generally applicable procedures. Adjudication officials would give due consideration to all evidence of record, including any consultant's opinion, and to the policy of resolving reasonable doubt in favor of the daimant Appeals of adverse decisions could be taken to the Board of Veterans Appeals. Proposed S 3.311b(a)(2] would provide for referral to the Department of Defense, for a dose estimate, all radiogenic-disease claims based on exposure during atmospheric nuclear weapons testing or during the occupation of Hiroshima and Nagasaki. In other claims where radiation exposure is alleged, the Chief Medical Director would review records bearing on the veteran's radiation dose and apply available methodologies in preparation of a dose estimate. Under proposed { 3Jllb(a)(3). if a claimant snbmits a radiation dose estimate from a credible source which differs materially from the estimate derived from official sources, an independent expert selected by the Director of the National institutes of Health will be asked to prepare a separate dose estimate for consideration with all other evidence in adjudication of the claim. To assure this procedure will be invoked only where differing estimates have been prepared by qualified persons having a familiarity with the claim at issue, a dose estimate would be considered from a credible source only if it was prepared by a person or persons certified by an appropriate governing body in the field of nuclear medicine or radiology and was based on analysis of the facts and circumstances of the veteran's exposure. The difference between a claimant's credible-source estimate and the dose estimate from official sources would ordinarily be considered material and require referral to an todependent expert if one estimate is at least double the other. However, the VA intends flexibility.in application of this provision based on the circumstances of the 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 than double the other. Conversely, when both estimates are very low, referral may not be necessary where, although one astinutetedraMearaanh^ttn doable i be of significance in adjaJfcntlun of the ! claim. -' \ Basis far crttmie. Die VA considen ' the proposed criteria for evaluation of radiation daims fuHy supported by sound scientific end medhml evidence and consistent with the policy of resolving reasonable doubt in favor of the daimant. In light of such evidence, the VA has tentatively concluded that service connection based on radiation exposure may be established for each disease referred to in section 2(5) of Pub. L 96-542. with the exception of polycythemia vera and chronic lymphatic leukemia. The BEIR Ifl report, page 287, Table A-l, indicated chronic lymphatic leukemia has not been observed as resulting from radiation exposure. The VA intends to request the advice of the Veterans' Advisory Committee on Environmental Hazards as to whether sound scientific and medical evidence exists linking these and other diseases to radiation exposure and anticipates that additional diseases may be included in the regulation as radiogenic diseases in the future. Studies reviewed in die BEIR HI report do not suggest a causal connection between akin cancer and low dose levels of ionizing radiation. A connection between skin cancer and radiation exposure at high dose levels is well-established, and akin cancer has. therefore, been included as a radiogenic disease in proposed { 3Jllb(b)(2). The VA notes the apparent absence of sound scientific and medical evidence supporting an association between skin cancer and exposure to low levels of ionizing radiation. The proposed regulations state that sound scientific and medical evidence does not establish a connection between polycythemia vera and radiation exposure. One study (Glyn G. Caldwell, et al.. Polycythemia Vera Among Participants ofa Nuclear Weapeas Test, Journal of the American Medical Association. Vel. 252. pp. 8*2-664 (1964)) of the health and mortality of participants in the "Smoky" atmospheric nuclear test found a greater than expected incidence of polycythemia vera among test participants. However, the lack of other supporting documentation suggests the apparent excess of polycythemia vera cases may have resulted from chance or misdiagnosis. Despite the proposed exclusion of polycythemia vera from the list of radiogenic diseases to $ &31lb(b)(2). service connection may nonetheless be established under generally applicable adjudication DSW 476038.0774 STLCOPCB4042938 MM__________ Federal legistm / Vol. 30. No. 77 / Monday. April 22. 1965 / Proposed Rules regulations for polycythemia vera Interim benefits would be payable for PART 1--{AMENDED] becoming manifest during a veteran's period of sarvice. In order to provide every reasonable the two-year period beginning October 1,1964, at the same rate as compensation for service-connected 1. Part 1 is amended by adding a new 11.17 to read as follows: consideration to veterans seeking to establish service connection, the VA has proposed use in 13.311b(b)(4) of the broadest periods of expected incidence supported by sound scientific and medical opinion. In particular, the BEIR III report staled that excess leukemias and bone cancers have been observed within 2 to 4 years after radiation exposure, but that evidence indicates the increased risk of these cancers becomes negligible 25 to 30 years after irradiation. The report goes on to state that, for all other radiation induced cancers reviewed, the minimal latent disability. If the veteran died from the disease, the survivors would be eligible for interim benefits, paid like dependency and indemnity compensation. Interim benefits would not be payable if there is affirmative evidence that the disease was precipitated by a known cause that occurred after the veteran's departure from the Republic of Vietnam. Also, interim benefits would not be payable if the veteran (or survivor) is receiving compensation for disability (or death) resulting from the chloracne of PCT. (1.17 evaluation of etudlea relating to nmn invcu o< umw mo rooMoon exposure. (a) From time to time, the Administrator shall publish evaluations of scientific or medical studies relating to the adverse health effects of exposure to 2,3,7,8 tetrachlorodibenzo-p-dioxin or ionizing radiation in the "Notices" section of the Federal Register. (b) Factors to be considered in evaluating scientific studies include: (1) Whether the study's findings are statistically significant and replicable. period is 10 years or more, and there is no indication increased cancer risk Regulatory Evaluations (2) Whether the study and its findings have withstood peer review. eventually declines. See BEIR III report, page 193. Probability-af-Caus<ftion Tables. The Orphan Drug Act. Pub. L 97-414.7(b), 96 Stat. 2049. 2060 (1983). directed the Department of Health and Human Services (HHS) to develop and update radioepldemiological tables relating to the probability that certain cancers could result from prior exposure to radiation. The resulting tables have only recently become available. The Administrator hereby certifies that these proposed regulations do not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act U.S.C. 681-612. Therefore, pursuant to 5 U.S.C. 805(b), these proposed regulations are exempt from the initial and final regulatory flexibility analyses requirements of section 603 and 604. The reason for this (3) Whether the study methodology has been sufficiently described to permit replication of the study. (4) Whetherjthe study's findings are applicable to the veteran population of interest (5) The views of the appropriate panel of the Scientific Council Of the Veterans' Advisory Committee on Environmental Hazards. (Pub. L 98-542) Because of a lack of data regarding the health effects of low-level radiation certification is that these regulations impose no regulatory burdens on small PART 3--{AMENDED] exposure, die reliability of any such entities, and only claimants for VA 2. Part 3 is amended by revising tables at the lower doses and for certain benefits will be directly affected. f 3.102. by removing and reserving cancers would be open to some in accordance with Executive Order { 3.311 and by adding new 3.311a, question. In fact the VA notes that the 12291, Federal Regulation, the VA has 3.311b and 3.813 so that the new and Ad Hoc Working Group which determined that these proposed revised material reads as follows: developed these tables identified many significant sources of uncertainty associated with the tables. Report of the National Institutes ofHealth Ad Hoc Working Croup to Develop Radioepidemiologicol Tables 7B-115 (1986). Therefore, the proposed regulations do not adopt the use of the HHS tables, but VA has sought the guidance of the Committee on Interagency Radiation Research and regulations are non-mBjor for the following reasons: (1) They will not have an effect on the economy of $100 million or mom: (2) They will not cause a major increase in costs or prices; (3) They will not have significant adverse effects on competition, employment, investment productivity, innovation, or on the ability of United States-based enterprises to compete with foreign- { 3.162 Sufficiency of the avtdaoce: benefit of reasonable doubt to the The policy of the VA in adjudicating claims is to administer the law under a broad interpretation, consistent with the facts shown in each claim. Evidence supporting the claimant's position must be sufficient to justify a belief in a fair and impartial mind that the claim is well grounded. Entitlement to benefits may Policy Coordination (CIRRPC) of the based enterprises in domestic or export not be based on pure speculation or Federal Coordinating Council for markets. remote possibility. When, after Science, Engineering and Technology (FCCSET) in order to asses the potential list of Subjects in 38 CFR Part 3 consideration of all evidence of record, there is an approximate balance of utility of employing the tables in some Administrative practice and positive and negative evidence fashion to adjudicate veterans' procedure, Claims, Handicapped, Health regarding the merits of an issue material compensation claims. The Veterans' care. Pensions, Veterans. to a claim, the benefit of the doubt in Advisory Committee on Environmental Hazards will also be asked for its views on this subject. The Catalog of Federal Domestic Assistance program numbers are 64.109 and 64.110. , resolving that issue shall be given to the claimant. (38 U.S.C. 210(c)) Section 3.613 Special interim benefits. * Approved: April 12,1985. This section implements section 9 of the Act. A Vietnam veteran disabled from chloracne or PCT would be eligible Harry N. Walter*. . Administrator. . ' ''' |3J11a Claims baaed on exposure to herbicides containing dtosln during service In the HapuMc of Vietnam. (a) Definitions. For purposes of this for special interim benefits ifthe disease 38 CFR Part 1, GENERAL and Part 3, section: became manifest.within one year of the ADJUDICATION, are amended as (1)"Service in the Republic of veteran's departuUreU fUrWomIU Va iec-tmnaomm.. follows^: Vt iiteo1t1nixaiimn " uinivculuuudeees servviicwe imn thh*ew wa--t--ers-- PCT ~ . DSW 476038.0775 STLCOPCB4042939 / vd. m n*.7x / IlMlfoy, Agwti M. 1985 / am offshore end aervioe in other teeationa. if the conditions of service involved duty or visitation to the Bapwblk of Vietnem. ' . (2) "Dioxin" memo* 2*74 tctnchlaredibanio-p-dtarin. (3) "Sound scientific evidence" mens observations, findings, or crmdnaiona which are statistically significant are capable of replication, and withstand peer review. (4) `Sound medioal evidence" means observations. findings, or condnsions which are consistent with current medical knowledge and are so reasonable and logical ae to serve as the basis for management af a medcial condition. (b) Presumption afexposure. A veteran who served in the Republic of Vietnam during theVietanraere shall be oresmned to have been exposed to a herbicide^oentatnag dioxin w&Ie hi Vietnam. The oossmenoement date of any period specified in paragraph (c) of this section shall be the day of the veteran's latest departure from the Republic of Vtotaam during such service. (c) Service-caanectioe based on dioxin exposure. Except at provided in paragraph (e) of this section, exposure to dioxin together with the development of the following diseaae within the period specified is sufficient to establish arviEe-onnnection for resulting disabilityfCEEuncm^iaanilested not later than umee mnnws from the date of exposure. (d) Diseases oat associated with dioxin axposureTSbund srirnlifir and medical evidencadnaa a cause and effect relationihin hetween dioxin exposure and the following: (Mfraiilitito rataline lants (3) Any other diseaae not specified in paragraphic) of this section. (e) Exceptions. Stovhce-connT'.ctian will not be established if the claimed disease ie dee to the vntaeaa's own willful misconduct or there is affirmative evidence that establishes a nonservicereiated supervening condition or event as the caeseef the disease. (f) Study evaluations, in the adjudication of individual datms. due consideration shall be given to the evaluations of study findings published pursuant to 11.17 of this tide. (g) Service-connection under other provisions. Nothing in this section will be construed to prevent the establishment of service-connection for any disease or disorder shown by sound scientific or medical evidence to have been incurred in or aggravated by active service. [h) fleers--Mi dsaht dtxftrme. With nmud to any inane matortol toffee dotorafcmtion afan todhddanl nhrira. the providoaa af I 3-Mef die tide shall apply. (M>.L.to-WS) 1341 lb Claims baaed on exposure to (a) Determinations ofexposure and dose--(1) Does assessment in aH claims in which it is established that a radiogenic disease. Hated in paragraph (b) (2) of thto aactina. first benwmr manifest after service and was not manifest to a oampanaable degree within any applicable presumptive period as specified in | 3.307, and it it contended the diseaae ia a result of exposure to ionising radiation in service, an assessment will be made aa to the size and >"> of the radiation dnae or doses. (2) Request for dose information. Where necessary pursuant to paragraph (a) (1) of this section, dose information will be requested as fallows: (i) Atmospheric nuclear weapons test- participation claims. In claims baaed upon participation in atmospheric nuclear testing, dose data wifi in all cases be requested from the appropriate office of The Department ofDefense. (ii) Hiroshima andNagasaki occupation claims, fat all claims based on participation in The American occupation of Hiroshima or Nagasaki. Japan, prior to July 1. IMS, dose data will be requested from the Department of Defense. ,, {iii) Other exposure claims. In aD other claims involving radiation exposure, a request wffl be made for the veteran's Record ofOccupational Exposure to Ionizing Radiation (ill) Form 1141). tf maintained, service medical records, and other reoords which any contain information pertaining to die veteran's radiation doee to service. AB such records wifi be forwarded to fite Chief Medical Director, who will be responsible for preparation of e doee estimate, to file extent feasible, based on available methodologies. (3) Referral to independent expert. When necessary to reconcile a material difference between an estimate of doee. from a credible source, submitted by or on behalf of a claimant, and dose data deriaed frost official nffttary records, the estimates and supporting documentation shall be referred to an independent expert, selected by the Directtr of theNatkntol Institutes of Health, who shall pnpare a separate radiattoa does cstioato for caashfarattoanlto adjudication of the claim. For purposes of this paragraph: (i) The difference claimant's asBmatv eng derived from ol 5W if one estimate is at least double the other estimate. - (ii) A dose estimate shall be considered from a "credible source" if prepared by a person or persons certified by an appropriate governing body in the field of nuclear msiBiane or radiology and if based on analysis of the facts and circumstances of (he particular claim. (4) Exposure. In rasas described in paragraph (a) (2) [Q and (a) [2} (ii) of this section: P) If military records da not establish presence at or absence from a site at which exposure to radiation ia t to have occunad. the veteran's presence at the site still be 34 (ii) Neither the irate an nor the veteran's survivors may be required 4a produce evidence subtoantiatuy exposure if the information lathe veteran's service reinsli or ether records matotafeed fry the D^ntotot of Defense to contestant wtth the oiatoi that the veteran was present-whom end when the claimed riqinesrr eceenmd. (b) initial review of dams 41} When it is determined: .. (i) A veteran sms expaeed to inatotog radiation aa a wash af participation in weapons; or Nagasaki. |apan. fan September 1945 until faly IMS; or other aCtisittos aa claimed; (ii) The veteran subsequently developed a nacUaga^ dtoaaae section;and ` *- . manifest wMtia the period spadfeed in paragraph (bH4) of this section: before its adjndfeatton the cfetai wffl be referred to the ChiefMet&cal Dfeetoer for further coagjderatiaa to aumhnre with parapaph (c) af fins section. If any of tbe foregoing 3 requirements fans not been met it shell net be determined that a disease has wetoted hem exposure to ionizing radiatios onderoocb circumstance*. (But see paragraph (b) of thto section.) (2) For purposes of paragraphs (a)(1) and (b)(1) af this section, "radiogenic disease" rlwfl toctude only the following: (i) All fonas oTIeukernfa except chronic lymphatic leukemia; (ii) Thyroid cancan (iii) Itowak breastcancer (iv) Long cancer . (v) Bone oancer (vi) Uver oancer and DSW 476038.0776 STLCOPCB4042940 (viii) Skia cancer. National Cancer Institute. The (3) For puipoaea of paragraphs (a)(1) consultant will be asked to evaluate the and (b)(1) of this section. "radiogenic claim and provide an opinion as to the disease" shall not include polycythemia likelihood the disease is a result of vera. exposure as claimed. (4) For purposes of paragraph (b)(1) of (2) The request for opinion shall be in this section: (i) Leukemias and bone cancer must writing and shall include a description of: become manifest more than 2 years but less than 30 years after exposure; (ii) Other forms of cancer specified in paragraph (b)(2) of this section must become manifest 10 years or more after exposure. (c) Review by ChiefMedical Director. (1) When e claim is forwarded for review pursuant to paragraph (b)(1) of this section, the Chief Medical Director shall consider the claim with reference to the factors specified in paragraph (e) of this section. (1) If after such consideration the Chief Medical Director is convinced sound scientific and medical evidence supports the conclusion it is at least as likely as not the veteran's disease resulted from exposure to radiation in service, the Chief Medical Director shall so inform the Chief Benefits Director in writing. The Chief Medical Director shall set forth the rationale for this conclusion, including an evaluation of the claim under the applicable factors specified in paragraph (e) of this section. (ii) If the Chief Medical Director determines there is no reasonable possibility that the veteran's disease resulted from radiation exposure in service, the Chief Medical Director shall so inform the Chief Benefits Director in writing, setting forth the rationale for this conclusion. (2) If the Chief Medical Director is unable to conclude whether it is at least as likely as not. or that there is no reasonable possibility, the veteran's disease resulted from radiation . exposure in service, the Chief Medical (1) The disease, including the specific call type and stage, If known, and when die disease first became manifest (ii) The circumstances, including date, ofthe veteran's exposure; (iii) The veteran's age, gender, and pertinent family history; (iv) The veteran's history of exposure to known carcinogens, occupationally or otherwise; (v) Evidence of any other effects radiation exposure may have had on the veteran; and' (vi) Any other information relevant to determination of causation of the veteran's disease. - The Chief Medical Director shall forward, with the request copies of pertinent medical records and, where available, dose assessments from official sources, from credible sources as defined in paragraph (a)(3)(ii) of this section, and Stain an independent expert pursuant to paragraph (a)(3) of this section. (3) The consultant shall evaluate the claim under the factors specified in paragraph (e) of this section and respond in writing, stating whether it is either likely, unlikely, or approximately as likely as not the veteran's disease resulted from exposure to ionizing radiation in service. The response shall s forth the rationale for the consultant's conclusion. Including the consultant's evaluation under the applicable factors specified in paragraph (e) of this section. The Chief Medical Director shall review the * Director shall refer the matter to an consultant's response and transmit it outside consultant in accordance with with any comments to the Chief Benefits paragraph (d) of this section. . Director for uaeJp adjudication of the (3) For purposes of paragraph (c)(1) of nfcln. . this section, "sound scientific evidence" |e) Factors for consideration. Factors means observations, findings, or to be considered in determining whether conclusions which are statistically aveteran's disease resulted from significant are capable of replication. - exposure to ionizing radiation in service and withstand peer review, and "sound include: medical evidence" means observations, (1) The probable dose, in terms of findings, or conclusions which are dose type, rate and duration as a factor consistent with current medical in inducing the disease, taking into knowledge and are so reasonable and account any known limitations in the logical as to serve as the basis of dosimetry devices employed in its management of a medical condition. measurement or the methodologies (d) Referral outside consultants, (l) employed in its estimation; Referrals pursuant to paragraph (c) of "(2) The relative sensitivity of the this section shall be to consultants involved tissue to induction, by ionizing selected by the Chief Medical Director radiation, of the specific pathology; from outside the VA. upon the (3) Tbs veteran's gender and pertinent recommendation of the Director of the family history; (4) The veteran's age at time of exposure; (5) The time-lapse between exposure and onset of the disease; and (6) The extent to which exposure to radiation, or other carcinogens, outside of service may have contributed to development of the disease. . (f) Adjudication ofclaim. The determination of service connection will be made under the generally applicable provisions of this part giving due consideration to all evidence of record, including any evaluation by the Chief Medical Director or an outside consultant, and to die evaluations published pursuant to f 1.17 of this title. Notwithstanding any determination under paragraph (c)(1) of this section, the Chief Benefits Director may request that the Chief Medical Director refer any claim to an outside consultant. With regard to any issue material to consideration of a claim, the provisions of | 3.102 of this title apply. (g) Willful misconduct and supervening cause. In no case will service connection be established if the disease is due to the veteran's own willful misconduct or if there is affirmative evidence to establish that a supervening, nonservice-related condition or event is more likely the cause of the disease. (h) Service connection otherwise established. Nothing in this section will be construed to prevent the establishment of service connection for any injury or disease otherwise shown by sound scientific or medical evidence to have been inclined or aggravated as a result of active service. (Pub. L M-S42) . |U1S Interim bottoms lor dteaMNy or death due to cNoracns or porphyria cutsnso tarda. (a) Disability benefits. Except as provided in paragraph (c) of this section, a veteran who served in the active military, naval or air service in the Republic of Vietnam during the Vietnam era, and who suffersJrqmchloracnaor porphyria cutanea tarda which became manifest within one year after the date of thelveteran's most recent departure from tiie Republic of Vietnam during such service, shall be paid interim disability benefit^ muter this wtinn in the same manner and to the same extent diet compensation would be payable if such disabilities wen serviceconnected. (b) Death benefits. Except as provided in paragraph (c) of this section, if a veteran described in paragraph (a) of this section dies as a result of chloracne or porphyria cutanea tarda, the DSW 476038.0777 STLCOPCB4042941 , / Vol. Sa*Na 77 t veteran's survivors dull be paid interim death benefits under this section based upon the same eligibility requirements and at the same rates that dependency and indemnity compensation would be payable if the death were service- connected. ` (c) Exceptions. Benefits andbr this section are not payable for any month for which compensation or dependency and indemnity compensation is payable for the same disability or death, nor are benefits payable under this section (1) when there is affirmative evidence that the disease was not incurred by the veteran during service in the Republic of Vietnam during the Vietnam era, (2) when there is affirmative evidence to establish that an internment hamper disease, which is a recognised Onee of the disease for which benefits arebehog claimed, was suffered by the veteran between the date of the veteran's moat recent departure from the Republic at Vietnam during active military, naval or air service and the onset of the claimed disease, or (3) if it is determined, based on evidence in the veteran's service records and other records provided by the Secretary of Defense, that the veteran was not exposed to dioxin during active military, naval or air service in the Republic of Vietnam during the Vietnam era. (d) Similarity to service-connected benefits. For purposes of all laws under this section shall be tnaMaf if H ware scrvice-coandcted, add foe reoeipt' of disability or death benefits heH be treated as tf such benefits won compensation or dependency and indemnity compensation, respectively. (e) Effective dates. Benefits under this section may not be paid for any period prior to October 1.1964. nor for any period after September 30. I960. (Pub. L. 90-542) (Oct 1.1964] [FR Doc. 85-9743 Filed 4-19-86; S*S am] eajjMO cooca-ei- n f r DSW 476038.0778 STLCOPCB4042942