[Federal Register Volume 59, Number 23 (Thursday, February 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2402]


[[Page Unknown]]

[Federal Register: February 3, 1994]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AG73

 

Disease Associated with Exposure to Certain Herbicide Agents 
(Multiple Myeloma and Respiratory Cancers)

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend 
its adjudication regulations concerning presumptive service connection 
for certain diseases even though there is no record of the disease 
during service. This proposed 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 
multiple myeloma and respiratory cancers. The intended effect of this 
proposed amendment is to establish presumptive service connection for 
those conditions based on herbicide exposure.

DATES: Comments must be received on or before March 7, 1994. Comments 
will be available for public inspection until March 15, 1994.

ADDRESSES: Interested persons are invited to submit written comments, 
suggestions, or objections regarding this amendment to Secretary of 
Veterans Affairs (271A), Department of Veterans Affairs, 810 Vermont 
Avenue, NW., Washington, DC 20420. All written comments received will 
be available for public inspection only in the Veterans Services Unit, 
room 170, at the above address between the hours of 8 a.m. and 4:30 
p.m., Monday through Friday (except holidays).

FOR FURTHER INFORMATION CONTACT: John Bisset, Jr., Consultant, 
Regulations Staff, Compensation and Pension Service, Veterans Benefits 
Administration, (202) 233-3005.

SUPPLEMENTARY INFORMATION: Section 2(a)(1) of the Agent Orange Act of 
1991, Public Law 102-4, 105 Stat. 11 (1991), added 38 U.S.C. 1116 which 
established presumptive service connection for veterans with service in 
the Republic of Vietnam during the Vietnam era who subsequently 
develop, to a degree of 10 percent or more, non-Hodgkin's lymphoma, 
soft-tissue sarcoma (subject to specified statutory exceptions), and 
chloracne or other acneform disease consistent with chloracne (within 
one year of the last date of active service in the Republic of Vietnam 
during the Vietnam era), even though there is no record of that disease 
during military service. Final regulations implementing this statutory 
provision were published in the Federal Register of May 19, 1993 (See 
58 FR 29107-09).
    Section 3 of Public Law 102-4 directed the Secretary to enter into 
an agreement with the National Academy of Sciences (NAS) to review the 
scientific evidence concerning the association between exposure to 
herbicides used in support of military operations in the Republic of 
Vietnam during the Vietnam era and each disease suspected to be 
associated with such exposure. Congress mandated that NAS determine, to 
the extent possible: (1) Whether there is a statistical association 
between the suspect diseases and herbicide exposure, taking into 
account the strength of the scientific evidence and the appropriateness 
of the methods used to detect the association; (2) the increased risk 
of disease among individuals exposed to herbicides during service in 
the Republic of Vietnam during the Vietnam era; and (3) whether there 
is a plausible biological mechanism or other evidence of a causal 
relationship between herbicide exposure and the suspect disease.
    Section 1116(b) of 38 U.S.C. provides that whenever the Secretary 
determines, based on sound medical and scientific evidence, that a 
positive association exists between exposure of humans to an herbicide 
agent (i.e., a chemical in an herbicide used in support of the United 
States and allied military operations in the Republic of Vietnam during 
the Vietnam era) and a disease, the Secretary will publish regulations 
establishing presumptive service connection for that disease. An 
association is considered ``positive'' if the credible evidence for the 
association is equal to or outweighs the credible evidence against the 
association. In making that determination, the Secretary is to consider 
reports received from NAS as well as other available sound medical and 
scientific evidence and analyses.
    After reviewing approximately 6,420 abstracts of scientific or 
medical articles and approximately 230 epidemiologic studies, 
consulting with outside experts, and conducting public hearings, NAS 
issued a report, entitled ``Veterans and Agent Orange: Health Effects 
of Herbicides Used in Vietnam'', on July 27, 1993. NAS concluded that 
there is sufficient evidence of an association between exposure to 
herbicides used in the Republic of Vietnam and the subsequent 
development of chloracne, non-Hodgkin's lymphoma, soft-tissue sarcoma, 
Hodgkin's disease and porphyria cutanea tarda. VA was already paying 
compensation for the first three conditions based upon the statutory 
presumptions established by Public Law 102-4, and the Secretary 
announced that same day that he had concluded that a positive 
association exists between exposure to herbicides used in the Republic 
of Vietnam and the subsequent development of Hodgkin's disease and 
porphyria cutanea tarda. Proposed regulations were published in the 
Federal Register on September 28, 1993 (See 58 FR 50528-30).
    The Secretary also announced that VA would review the remaining 
findings in the NAS report to determine whether a positive association 
exists between herbicide exposure and any other conditions. That review 
has been completed and the Secretary has concluded that a positive 
association exists for multiple myeloma and respiratory cancers. The 
NAS report found ``limited/suggestive evidence''--a category it defined 
as meaning that evidence suggests an association between herbicide 
exposure and a specific disease, but that chance, bias, and confounding 
cannot be ruled out with confidence--of an association between 
herbicide exposure and the subsequent development of multiple myeloma. 
VA, however, found the evidence concerning multiple myeloma, a 
malignant proliferation of plasma cells which are derived from B 
lymphocytes, to be convincing. Most of the studies reviewed by NAS 
showed an increased risk, although in most cases it was not a 
statistically significant increase. One occupational study (Fingerhut 
M.A., Halperin W.E., Marlow D.A., Piacitelli L.A., Honchar P.A., 
Sweeney M.H., Greife A.L., Dill P.A., Steenland K., Suruda A.J. 1991. 
Cancer mortality in workers exposed to 2,3,7,8-tetrachlorodibenzo-p-
dioxin. New England Journal of Medicine 324:212-218) found a 
relationship between herbicide exposure and multiple myeloma. Although 
this finding was not supported by the findings of Saracci and 
colleagues (Saracci R., Kogevinas M., Bertazzi P.A., Bueno De Mesquita 
B.H., Coggon D., Green L.M., Kauppinen T., L'Abbe K.A., Littorin M., 
Lynge E., Mathews J.D., Neuberger M., Osman J., Pearce N., Winkelman R. 
1991. Cancer mortality in workers exposed to chlorophenoxy herbicides 
and chlorophenols. Lancet 338:1027-1032), the Saracci study is flawed 
as a result of questions regarding exposure. Another study (Pesatori 
A.C., Consonni D., Tironi A., Landi M.T., Zocchetti C., Bertazzi P.A. 
1992. Cancer morbidity in the Seveso area, 1976-1986. Chemosphere 
25:209-212) showed a clear association between herbicide exposure and 
multiple myeloma in both males and females. Moreover, multiple myeloma 
is closely related biologically to B-cell non-Hodgkin's lymphoma; 
consequently, the epidemiological evidence concerning non-Hodgkin's 
lymphoma gives added weight to the association between herbicide 
exposure and multiple myeloma. Based on this clinical consideration and 
the weight of the epidemiogical evidence, the Secretary has determined 
that there is a positive association between herbicide exposure and 
multiple myeloma that manifests itself to a degree of 10 percent at any 
time after exposure. We are proposing to amend 38 CFR 3.309(e) to 
implement the Secretary's decision. This amendment is proposed to be 
effective the date of publication of the final rule, as provided by 
Public Law 102-4.
    The NAS report also found limited/suggestive evidence of an 
association between herbicide exposure and the subsequent development 
of respiratory cancers, specifically cancers of the lung, larynx, or 
trachea. For study purposes, NAS included cancer of the bronchus when 
it considered cancer of the lung; therefore, we are including cancer of 
the bronchus within the scope of the proposed presumption.
    In reviewing the NAS report, which noted that not all studies had 
fully controlled for or evaluated smoking as a confounding factor, VA 
gave weight to the fact that the studies found high relative risks for 
respiratory cancers in production workers (Manz A., Berger J., Dwyer 
J.H., Flesch-Janys D., Nagel S., Waltsgott H. 1991. Cancer mortality 
among workers in chemical plant contaminated with dioxin. Lancet 
338:959-964; Fingerhut et al., 1991). The Fingerhut study showed an 
increased risk with the duration of exposure. VA also noted that 
despite the failure of some studies to control for smoking, it is 
unlikely that there were major differences in smoking patterns between 
the study and control groups. Considering all of the evidence, the 
Secretary has determined that the credible evidence for an association 
outweighs the credible evidence against an association and that there 
is, therefore, a positive association between exposure to herbicides 
used in the Republic of Vietnam and the subsequent development of 
respiratory cancers.
    VA also found that the weight of the available evidence indicates 
that chemically-induced respiratory cancers manifest within a definite 
period following exposure, after which there is little effect from the 
exposure (Finkelstein M.M., 1991. Use of ``time windows'' to 
investigate lung cancer latency intervals at an Ontario steel plant. 
American Journal of Industrial Medicine 19:299-235). In our judgment, 
it is reasonable to assume that respiratory cancers due to herbicide 
exposure will show a risk pattern similar to other chemically-induced 
respiratory cancers, and we are proposing as part of our rule that 
respiratory cancer will be presumed service connected only if it is 
manifest within 30 years after exposure. The longest manifestation 
period noted for a respiratory cancer following herbicide exposure is 
about 30 years (Zach J.A., Suskind R.R. 1980. The mortality experience 
of workers exposed to tetrachlorodibenzodioxin in a trichlorophenol 
process accident. Journal of Occupational Medicine 22:11-14; Zober A., 
Messerer P., Huber P. 1990. Thirty-four year mortality follow-up of 
BASF employees to 2,3,7,8-TCDD after the 1953 accident. Occupational 
Environmental Health 62:139-157). If future studies indicate that this 
manifestation period is inappropriate, VA will amend it accordingly. We 
are proposing to amend 38 CFR 3.307(a) and 3.309(e) to implement the 
Secretary's decision. This amendment is proposed to be effective the 
date of publication of the final rule, as provided by Public Law 102-4.
    38 U.S.C. 1113 provides that where there is affirmative evidence to 
the contrary, or evidence to establish that an intercurrent injury or 
disease which is a recognized cause of any of the diseases for which 
presumptive service connection may be allowed under the provisions of 
38 U.S.C. 1112 (i.e., chronic diseases, tropical diseases, prisoner-of-
war related diseases, or diseases specific to radiation-exposed 
veterans), has been suffered between the date of separation from 
service and the onset of any such diseases, or the disability is due to 
the veteran's own willful misconduct, presumptive service connection 
will not be in order. Section 2(b) of public law 102-4 amends 38 U.S.C. 
1113 so that its provisions also apply to the presumptive conditions 
associated with herbicide exposure under 38 U.S.C. 1116. Consequently, 
service connection for multiple myeloma or respiratory cancers based on 
herbicide exposure is precluded if there is affirmative evidence that 
establishes a non-service related supervening condition or event as the 
cause of the multiple myeloma or respiratory cancers, or the disability 
is due to the veteran's own willful misconduct (See 38 U.S.C. 1113).
    The Secretary hereby certifies that this regulatory amendment 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. The reason for this certification is that this 
amendment would not directly affect any small entities. Only VA 
beneficiaries could be directly affected. Therefore, pursuant to 5 
U.S.C. 605(b), this amendment is exempt from the initial and final 
regulatory flexibility analysis requirements of sections 603 and 604.
    The Secretary has determined that it is not feasible to allow the 
60 day comment period referred to in section 6(a)(1) of Executive Order 
12866 because a comment period of that length would prevent VA from 
complying with the statutory requirement to publish a final rule within 
90 days of publication of the proposed rule imposed by 38 U.S.C. 
1116(c)(2).

    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, Handicapped, Health 
care, Pensions, Veterans.

    Approved: December 3, 1993.
Jesse Brown,
Secretary of Veterans Affairs.

    For the reasons set out in the preamble, 38 CFR part 3 is proposed 
to be amended as set forth below:

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.

    2. In Sec. 3.307, paragraph (a)(6)(ii), is revised to read as 
follows:


Sec. 3.307  Presumptive service connection for chronic, tropical or 
prisoner-of-war related disease, or disease associated with exposure to 
certain herbicide agents; wartime and service on or after January 1, 
1947.

    (a) * * *
    (6) * * *
    (ii) The diseases listed at Sec. 3.309(e) shall have become 
manifest to a degree of 10 percent or more at any time after service, 
except that chloracne or other acneform disease consistent with 
chloracne and porphyria cutanea tarda shall have become manifest to a 
degree of 10 percent or more within a year, and respiratory cancers 
within 30 years, after the last date on which the veteran was exposed 
to an herbicide agent during active military, naval, or air service.
* * * * *


Sec. 3.309  [Amended]

    3. In Sec. 3.309(e) in the listing of diseases, after the words 
``Hodgkin's disease'' and before the words ``Non-Hodgkin's lymphoma'', 
add the words ``Multiple myeloma''; and after the words ``Porphyria 
cutanea tarda'' and before the words ``Soft-tissue sarcoma (other than 
osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or mesothelioma)'', add 
the words ``Respiratory cancers (cancer of the lung, bronchus, larynx, 
or trachea)''.

[FR Doc. 94-2402 Filed 2-2-94; 8:45 am]
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