[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]
BILLING CODE 8320-01-P
