96-28683. Diseases Associated With Exposure to Certain Herbicide Agents (Prostate Cancer and Acute and Subacute Peripheral Neuropathy)

  • [Federal Register Volume 61, Number 217 (Thursday, November 7, 1996)]
    [Rules and Regulations]
    [Pages 57586-57589]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-28683]
    
    
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    DEPARTMENT OF VETERANS AFFAIRS
    
    38 CFR Part 3
    
    RIN 2900-AI35
    
    
    Diseases Associated With Exposure to Certain Herbicide Agents 
    (Prostate Cancer and Acute and Subacute Peripheral Neuropathy)
    
    AGENCY: Department of Veterans Affairs.
    
    ACTION: Final rule.
    
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    SUMMARY: This document amends the Department of Veterans Affairs (VA) 
    adjudication regulations concerning presumptive service connection for 
    certain diseases for which there is no record of the disease during 
    service. This amendment is necessary to implement a decision of the 
    Secretary of Veterans Affairs, under the authority granted by the Agent 
    Orange Act of 1991, that there is a positive association between 
    exposure to herbicides used in the Republic of Vietnam during the 
    Vietnam era and the subsequent development of prostate cancer and acute 
    and subacute peripheral neuropathy. The intended effect of this 
    amendment is to establish presumptive
    
    [[Page 57587]]
    
    service connection for those conditions based on herbicide exposure.
    
    EFFECTIVE DATE: This amendment is effective November 7, 1996.
    
    FOR FURTHER INFORMATION CONTACT: John Bisset, Jr., Consultant, 
    Regulations Staff, Compensation and Pension Service (213), Veterans 
    Benefits Administration, 810 Vermont Avenue, NW, Washington, DC 20420, 
    telephone (202) 273-7230.
    
    SUPPLEMENTARY INFORMATION: VA published a proposal to amend 38 CFR 
    3.307(a) and 3.309(e) to establish presumptive service connection for 
    prostate cancer and acute and subacute peripheral neuropathy based on 
    exposure to herbicides in the Federal Register of August 8, 1996 (61 FR 
    41368-71). Interested persons were invited to submit written comments 
    concerning the proposal on or before September 9, 1996. We received 
    three comments from private individuals; one comment from a veterans' 
    service organization, the Vietnam Veterans of America, Inc.; and one 
    comment from a United States Senator.
        The Vietnam Veterans of America, Inc., indicated that it had no 
    reservations with the language of the proposed rule, commended VA's 
    timely response to the 1996 National Academy of Sciences (NAS) report 
    ``Veterans and Agent Orange: Update 1996,'' and urged VA to publish the 
    final regulations as soon as possible in order to afford the earliest 
    possible effective date for compensation benefits based on herbicide-
    related prostate cancer and acute and subacute peripheral neuropathy.
        Two commenters asked that VA defer publishing final regulations 
    until it could study Vietnam veterans suffering from chronic peripheral 
    neuropathy.
        38 U.S.C. 1116(c)(1)(A) requires that the Secretary, not later than 
    60 days after the date on which he receives a report from NAS, 
    determine whether a presumption of service connection is warranted for 
    each disease covered by the report and, if the Secretary determines 
    that a presumption is warranted, issue proposed regulations within 60 
    days thereafter. 38 U.S.C. 1116(c)(2) requires the Secretary to issue 
    final regulations establishing presumptive service connection for any 
    condition for which he determines there is a positive association with 
    exposure of humans to an herbicide agent not later than 90 days after 
    he has issued proposed regulations. The Secretary is not free to ignore 
    these statutory requirements. For reasons more fully explained in the 
    proposal, the Secretary has concluded that presumptive service 
    connection is warranted for acute and subacute peripheral neuropathy, 
    and VA is, therefore, proceeding with publication of a final rule 
    notwithstanding these comments.
        One commenter noted that VA had previously proposed to recognize an 
    association between peripheral neuropathy and exposure to dioxin 
    without excluding chronic peripheral neuropathy and stated it should 
    now recognize chronic peripheral neuropathy as associated with 
    herbicide exposure since the only changed circumstance was VA's 
    subsequent contract with NAS to review, summarize, and assess the 
    scientific evidence concerning the association between herbicide 
    exposure and particular diseases.
        In the Federal Register of January 21, 1992 (See 57 FR 2236-38), VA 
    published a proposed rule to recognize an association between 
    peripheral neuropathy and exposure to herbicides containing dioxin; 
    however, a final rule was never published. That proposed rulemaking was 
    initiated to implement a preliminary determination under the provisions 
    of the Veterans' Dioxin and Radiation Exposure Compensation Standards 
    Act, Public Law 98-542, that there was a significant statistical 
    association between exposure to herbicides containing dioxin and the 
    subsequent development of peripheral neuropathy.
        The Agent Orange Act of 1991, Public Law 102-4, established 
    different standards governing VA rulemaking than were applicable under 
    Public Law 98-542. Under the Agent Orange Act, VA is required to 
    determine, based on reports from NAS and all other sound medical and 
    scientific information and analyses available to it, whether the 
    credible evidence for an association between herbicide exposure and a 
    disease is equal to or outweighs the credible evidence against an 
    association. NAS reports received by VA in 1993 and 1996 reviewed a 
    broader range of medical and scientific evidence than VA had considered 
    in connection with the 1992 proposed rules, including several studies 
    published since January 21, 1992, and concluded that there was 
    inadequate/insufficient evidence to determine whether an association 
    exists between herbicide exposure and chronic peripheral neuropathy. 
    Pursuant to the standards of the Agent Orange Act, VA has determined 
    that the evidence against an association between herbicide exposure and 
    chronic peripheral neuropathy outweighs the evidence for such an 
    association and has published a notice of that determination, including 
    an explanation of the scientific basis for that determination, in the 
    Federal Register of August 8, 1996 (See 61 FR 41442, 41446-47). 
    Accordingly, because VA's determination is based upon a different, and 
    more comprehensive, body of evidence, and the specific rulemaking 
    requirements of the Agent Orange Act, we take no action based on this 
    comment.
        Another commenter urged VA to expand the scope of the proposed rule 
    to include presumptive service connection for chronic peripheral 
    neuropathy because of the lack of uniformity in the scientific 
    literature.
        NAS, in its 1996 report, assigned chronic peripheral neuropathy to 
    a category labeled inadequate/insufficient evidence to determine 
    whether an association exists. NAS defined that category as meaning 
    that the available studies are of insufficient quality, consistency, or 
    statistical strength to permit a conclusion regarding the presence or 
    absence of an association with herbicide exposure. The studies reviewed 
    by NAS suggested that the development of peripheral neuropathy can 
    follow high levels of exposure to herbicides, and that peripheral 
    neuropathy associated with herbicide exposure will manifest very soon 
    after exposure. The trend to recovery reported and the negative 
    findings of many long-term followup studies of peripheral neuropathy 
    suggested that if such a neuropathy develops, it resolves with time. 
    These findings are consistent with the findings of other studies that 
    found no evidence of increased occurrence of chronic peripheral 
    neuropathy after TCDD exposure. The Secretary determined that a 
    positive association does not exist between herbicide exposure and the 
    subsequent development of chronic peripheral neuropathy (See 61 FR 
    41446-47). Accordingly, VA takes no action based on this comment.
        One commenter submitted analyses by two individuals contending 
    there is an association between herbicide exposure and chronic 
    peripheral neuropathy and stated that NAS did not consider these 
    analyses.
        The first of those analyses is contained in a February 19, 1992, 
    letter from an environmental scientist with the United States 
    Environmental Protection Agency (EPA) commenting on VA's January 1992 
    proposed rule to recognize an association between herbicide exposure 
    and peripheral neuropathy becoming manifest within 10 years after 
    exposure to herbicides containing dioxin. As noted above, the proposed 
    rule was never finalized. The comment, among other things, disagreed 
    with the proposal to limit the
    
    [[Page 57588]]
    
    recognized association to only those peripheral neuropathies becoming 
    manifest within 10 years after exposure. The commenter asserted that 
    neurotoxic damage, such as peripheral neuropathy, may not be clinically 
    detectable for many years and that, therefore, peripheral neuropathy 
    due to herbicide exposure may become manifest more than ten years after 
    exposure. Although NAS apparently did not consider the February 19, 
    1992, letter to VA in its review of the medical and scientific 
    literature, we note that the author of that letter presented testimony 
    to NAS at the September 9, 1992, public meeting held by NAS prior to 
    the issuance of its initial report. (Veterans and Agent Orange: Health 
    Effects of Herbicides Used in Vietnam, 1993, Appendix B, B-10.). To 
    that extent, this author's views have been called to the attention of 
    NAS.
        The second analysis submitted by the commenter is contained in a 
    May 26, 1995, letter from a retired consultant in genetic toxicology to 
    an American Legion official discussing the initial NAS report. The 
    author of that letter stated that the methodology and analysis used by 
    NAS was deficient in failing to give proper consideration to studies of 
    toxicological effects in animals, failing to give proper consideration 
    to clinical reports of individual cases involving herbicide exposure 
    and its effects, and failing to address the synergistic effects of 
    exposure to other substances, such as insecticides, disinfectants, 
    solvents, and prescription drugs. The author further stated that 
    peripheral neuropathy is strongly associated with human exposure to 
    components of herbicides used in Vietnam, and that the author was 
    personally aware of published clinical reports of 54 individuals who 
    developed peripheral neuropathy shortly after exposure to 2,4-D.
        Based on its review of numerous studies and case reports, NAS 
    concluded that, although some case reports suggested that acute or 
    subacute peripheral neuropathy can develop shortly after exposure to 
    dioxin and related products, the most rigorously conducted studies 
    argued against a relationship between dioxin or herbicides and chronic 
    peripheral neuropathy. In view of the evidence that acute and subacute 
    peripheral neuropathies resolve within a short time and the negative 
    findings of the most rigorous long-term studies of herbicide exposure, 
    VA has concluded that the evidence against an association between 
    chronic peripheral neuropathy and herbicide exposure outweighs the 
    evidence for such an association. The analyses submitted by the 
    commenter do not alter that conclusion.
        Although one of the analyses states that the effects of neurotoxic 
    damage, such as peripheral neuropathy, may first become clinically 
    detectable many years after exposure, the studies discussed by NAS, 
    including followup studies conducted 15 and 30 years after exposure, 
    generally showed no significant increase in peripheral neuropathy in 
    the exposed populations. Further, although the other analysis 
    referenced clinical reports of 54 individuals who developed peripheral 
    neuropathy shortly after exposure to 2,4-D, that fact is consistent 
    with the conclusion that acute and subacute peripheral neuropathy may 
    develop shortly after exposure but does not demonstrate that chronic 
    peripheral neuropathy is associated with herbicide exposure. The 
    alleged methodological deficiencies in the 1993 NAS report also do not 
    alter our conclusion. The 1996 NAS report discussed both animal studies 
    and case reports, where relevant, in its review of the available 
    scientific and medical literature. Further, NAS properly focused on the 
    health effects of exposure to herbicides, as required by the Agent 
    Orange Act of 1991, rather than on exposure to other substances.
        This same commenter also forwarded a copy of a General Accounting 
    Office (GAO) report concerning (1) the efforts of the Department of 
    Health and Human Services' Centers for Disease Control (CDC) to study 
    the effects of Agent Orange on the health of Vietnam veterans and (2) 
    CDC's contracting and contract administration practices on contracts it 
    awarded for the studies. Since this GAO report does not concern the NAS 
    literature review or its recommendations regarding prostate cancer or 
    peripheral neuropathy, we will not amend the proposed rule based on 
    that report.
        Another commenter said that in estimating the five-year benefit 
    cost of this rulemaking, VA should consider that, in the case of 
    retired military personnel, any increase in VA benefit payments is 
    offset by a reduction in military retired pay.
        When estimating the cost of a proposed rule, VA is determining the 
    potential cost to VA rather than to the Federal Government as a whole. 
    However, VA recognizes that the cost to the Government of expansion of 
    entitlement to compensation based on herbicide exposure may be offset 
    to some degree by a reduction in military retired pay because retired 
    servicemembers cannot receive both benefits concurrently and must waive 
    retired pay to receive compensation from VA.
        The six-year benefit costs for prostate cancer based on herbicide 
    exposure is $65.3 million, with an administrative cost of $959,000. 
    Additionally, the medical care cost over six years is $38 million. 
    Prostate cancer is a male genitourinary cancer that shows marked 
    increased prevalence with age. Accordingly, costs beyond the six-year 
    period would likely be substantially higher.
        VA appreciates the comments submitted in response to the proposed 
    rule which is now adopted without change; except that amendatory 
    instruction # 2 is changed from the proposal to correct a typographical 
    error.
        Pursuant to the provisions of 38 U.S.C. 1116(c)(2), this final rule 
    is made effective on the date of publication in the Federal Register.
        The Secretary hereby certifies that these regulatory amendments 
    will not have a significant economic impact on a substantial number of 
    small entities as they are defined in the Regulatory Flexibility Act 
    (RFA), 5 U.S.C. 601-612. These amendments would not directly affect any 
    small entities. Only claimants for VA benefits could be directly 
    affected. Therefore, pursuant to 5 U.S.C. 605(b), these amendments are 
    exempt from the initial and final regulatory flexibility analysis 
    requirements of sections 603 and 604.
    
        The Catalog of Federal Domestic Assistance program numbers are 
    64.109 and 64.110.
    
    List of Subjects in 38 CFR Part 3
    
        Administrative practice and procedure, Claims, Disability benefits, 
    Health care, Pensions, Veterans, Vietnam.
    
        Approved: October 29, 1996.
    Jesse Brown,
    Secretary of Veterans Affairs.
    
        For the reasons set forth in the preamble, 38 CFR part 3 is amended 
    as follows:
    
    PART 3--ADJUDICATION
    
    Subpart A--Pension, Compensation, and Dependency and Indemnity 
    Compensation
    
        1. The authority citation for part 3, subpart A continues to read 
    as follows:
    
        Authority: 38 U.S.C. 501(a), unless otherwise noted.
    
    
    Sec. 3.307  [Amended]
    
        2. In Sec. 3.307, paragraph (a)(6)(ii) is amended by removing 
    ``chloracne and''
    
    [[Page 57589]]
    
    and adding, in its place, ``chloracne,''; and by adding ``, and acute 
    and subacute peripheral neuropathy'' immediately following ``tarda''.
    
    
    Sec. 3.309  [Amended]
    
        3. In Sec. 3.309, paragraph (e), the listing of diseases is amended 
    by adding ``Acute and subacute peripheral neuropathy'' between ``Non-
    Hodgkin's lymphoma'' and ``Porphyria cutanea tarda''; by adding 
    ``Prostate cancer'' between ``Porphyria cutanea tarda'' and 
    ``Respiratory cancers (cancer of the lung, bronchus, larynx, or 
    trachea)''.
        4. Section 3.309, paragraph (e) is further amended by redesignating 
    the Note as ``Note 1:''; and by adding ``Note 2:'' immediately 
    following the last entry in note 1 to read as follows:
    
    
    Sec. 3.309  Disease subject to presumptive service connection.
    
    * * * * *
        (e) * * *
    
        Note 2: For purposes of this section, the term acute and 
    subacute peripheral neuropathy means transient peripheral neuropathy 
    that appears within weeks or months of exposure to an herbicide 
    agent and resolves within two years of the date of onset.
    
    [FR Doc. 96-28683 Filed 11-6-96; 8:45 am]
    BILLING CODE 8320-01-P
    
    
    

Document Information

Effective Date:
11/7/1996
Published:
11/07/1996
Department:
Veterans Affairs Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-28683
Dates:
This amendment is effective November 7, 1996.
Pages:
57586-57589 (4 pages)
RINs:
2900-AI35
PDF File:
96-28683.pdf
CFR: (2)
38 CFR 3.307
38 CFR 3.309