E9-10627. 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 AL amyloidosis. The intended effect of this amendment is to establish presumptive service connection for AL amyloidosis based on herbicide exposure.

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, [phone]. (This is not a toll-free number.)

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.

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 § 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.

Response

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; 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 follows:

PART 3—ADJUDICATION

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

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

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

§ 3.309

[Amended]

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