[Federal Register Volume 74, Number 87 (Thursday, May 7, 2009)]
[Rules and Regulations]
[Pages 21258-21260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10627]



38 CFR Part 3

RIN 2900-AN01

Presumptive Service Connection for Disease Associated With 
Exposure to Certain Herbicide Agents: AL Amyloidosis

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.


SUMMARY: This document amends the Department of Veterans Affairs (VA) 
adjudication regulations concerning presumptive service connection for 
a certain disease based on the most recent National Academy of Sciences 
(NAS) Institute of Medicine committee report, ``Veterans and Agent 
Orange: Update 2006'' (Update 2006). This amendment is necessary to 
implement a decision of the Secretary of Veterans Affairs 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

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AL amyloidosis. The intended effect of this amendment is to establish 
presumptive service connection for AL amyloidosis based on herbicide 

DATES: Effective Date: This amendment is effective May 7, 2009.
    Applicability Date: The provisions of this regulation amendment 
apply to all applications for benefits pending before VA on or received 
after May 7, 2009. They also apply to review of certain previously 
denied claims to the extent provided in 38 CFR 3.816.

FOR FURTHER INFORMATION CONTACT: Maya Ferrandino, Regulations Staff 
(211D), Compensation and Pension Service, Veterans Benefits 
Administration, Department of Veterans Affairs, 810 Vermont Avenue, 
NW., Washington, DC 20420, (727) 319-5847. (This is not a toll-free 

SUPPLEMENTARY INFORMATION: On November 3, 2008, VA published in the 
Federal Register at 73 FR 65280 a proposal to amend 38 CFR 3.309(e) to 
add AL amyloidosis to the list of diseases presumed service connected 
based on exposure to herbicide agents. Interested persons were invited 
to submit written comments on or before January 2, 2009. We received 
one comment.


    The commenter stated that the proposed rule represents an 
ideological shift in disease categorization. The commenter stated that 
the proposed rule does not reflect the current criteria for causality 
contained in 38 U.S.C. 1116(b), which he stated requires direct 
evidence between exposure to an herbicide agent and the occurrence of a 
disease in humans. The commenter stated that the evidence that multiple 
myeloma and other lymphomas were connected to herbicide exposure was 
used by the Secretary to connect AL amyloidosis with herbicide exposure 
and that this process by the Secretary reflects a policy of providing 
service connection for disease groups rather than for separate 
diseases. He noted that section 1116(b) allows for service connection 
for a specific disease rather than for a group of diseases. The 
commenter stated that should the proposed rule go forward, section 
1116(b) and Sec.  3.309(e) should be revised to include service 
connection for disease entities and that regulations that refer to 
individual diseases should be reviewed and revised. He stated that the 
proposed rule could be revised to reflect a presumption of service 
connection for all diseases characterized by clonal hyperproliferation 
of B-cell derived plasma cells and production of abnormal amounts of 
immunoglobulins. The commenter stated that, in the alternative, the 
proposed rule should be withdrawn because there is no evidence that 
this disease entity is associated with exposure to herbicides.


    As stated in the proposed rule, the Secretary's determination 
regarding establishing presumptive service connection for AL 
amyloidosis is based on NAS' evaluation and its conclusion that there 
is limited or suggestive evidence of an association between herbicide 
exposure and AL amyloidosis. The Secretary did not make any 
determination concerning any disease other than AL amyloidosis. In this 
regard, the Secretary has followed the standards in section 1116(b) 
regarding establishing presumptive service connection for a disease 
associated with herbicide exposure. The comment states that this rule 
amends the ``causality'' criteria of section 1116(b). However, as shown 
in Update 2006, after quoting the criteria from section 1116(b), ``[the 
NAS committee's] congressional mandate and its statement of task are 
phrased in such a way that the target of evaluation is `association,' 
not `causality,' between exposure and health outcomes.'' Update 2006, 
p. 2.
    The commenter's suggestion that this rule is contrary to section 
1116(b) rests on the premise that the rule implicitly establishes a 
presumption for a group of related diseases, rather than for a specific 
disease. We do not agree with that premise. As noted above, the NAS and 
VA each made a finding specific to AL amyloidosis. As the commenter 
noted, the NAS relied primarily upon studies showing that AL 
amyloidosis is pathophysiologically related to other diseases that are 
currently presumed to be associated with herbicide exposure. That 
analysis, however, should not be interpreted to mean that an 
association between herbicide exposure and a particular disease 
justifies a finding of such an association for all similar or related 
diseases. Rather, the NAS and VA necessarily evaluate the body of 
relevant evidence for each disease.
    The NAS noted that, because AL amyloidosis is a rare condition, 
``it is not likely that population-based epidemiology will ever provide 
substantial direct evidence regarding its causation.'' Update 2006, p. 
474. By statute, the NAS is directed to assess not only statistical 
associations based on epidemiologic studies, but also other factors 
such as ``whether there exists a plausible biological mechanism or 
other evidence of a causal relationship between herbicide exposure and 
the disease.'' Public Law 102-4, section 3(d)(1)(C). It appears that 
the NAS may have placed significant weight on the evidence of biologic 
plausibility in this instance in part because it is unlikely that other 
forms of relevant evidence for or against an association will ever 
become available. However, the determinations by NAS and VA concerning 
Al amyloidosis cannot reasonably be construed to reflect a shift in 
policy deviating from the requirements of section 1116(b), or to 
suggest that epidemiologic evidence is irrelevant to determinations 
concerning other diseases.
    To the extent the commenter suggests an amendment to section 
1116(b), such action would require legislation and is beyond the scope 
of this rule. We therefore make no change based on this comment.
    VA appreciates the comment submitted in response to the proposed 
rule. Based on the rationale set forth in the proposed rule and the 
rationale contained in this document, we are adopting the provisions of 
the proposed rule as a final rule without change.

Administrative Procedures Act

    Substantive changes made by this final rule are required to be 
effective the date of issuance pursuant to 38 U.S.C. 1116(c)(2). 
Accordingly, we are dispensing with the delayed effective date 
provisions of 5 U.S.C. 553.

Paperwork Reduction Act

    This document contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. This final rule will not affect any small entities. Only VA 
beneficiaries could be directly affected. Therefore, pursuant to 5 
U.S.C. 605(b), this final rule is exempt from the initial and final 
regulatory flexibility analysis requirements of sections 603 and 604.

Executive Order 12866

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages;

[[Page 21260]]

distributive impacts; and equity). The Executive Order classifies a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), as any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    The economic, interagency, budgetary, legal, and policy 
implications of this final rule have been examined and it has been 
determined to be a significant regulatory action under the Executive 
Order because it is likely to result in a rule that may raise novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any year. This final rule would have no such effect on 
State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance Numbers and Titles

    The Catalog of Federal Domestic Assistance program numbers and 
titles for this rule are 64.109, Veterans Compensation for Service-
Connected Disability, and 64.110, Veterans Dependency and Indemnity 
Compensation for Service-Connected Death.

List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, 
Health care, Veterans, Vietnam.

    Approved: April 3, 2009.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.

For the reasons set forth in the preamble, 38 CFR part 3 is amended as 


1. The authority citation for part 3, subpart A, continues to read as 

    Authority:  38 U.S.C. 501(a), unless otherwise noted.

Subpart A--Pension, Compensation, and Dependency and Indemnity 

Sec.  3.309  [Amended]

2. In Sec.  3.309(e), the listing of diseases is amended by adding ``AL 
amyloidosis'' immediately preceding ``Chloracne or other acneform 
disease consistent with chloracne.''

[FR Doc. E9-10627 Filed 5-6-09; 8:45 am]