Presumptive Service Connection For Al Amyloidosis

[allan]

Pass this on to all your contacts…Put in Post newsletters.. Many Veterans, and widows, will never hear about this.

Contact a VSO or an attorney and file, refile, etc for benefits. If you served in Vietnam or other places that AO was used. File…file…

Amyloidosis is a rare and potentially fatal disease that occurs when substances called amyloid proteins build up in your organs. Amyloid is an abnormal protein usually produced by cells in your bone marrow that can be deposited in any tissue or organ.

Amyloidosis can affect different organs in different people, and there are many types of amyloid. Amyloidosis frequently affects the heart, kidneys, liver, spleen, nervous system and gastrointestinal tract.

http://edocket.access.gpo.gov/2009/E9-10627.htm

[Federal Register: May 7, 2009 (Volume 74, Number 87)]

[Rules and Regulations]

[Page 21258-21260]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr07my09-8]

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DEPARTMENT OF VETERANS AFFAIRS

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.

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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

[[Page 21259]]

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, (727) 319-5847. (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 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.

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)©. 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©(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.

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

follows:

PART 3--ADJUDICATION

0

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

Sec. 3.309 [Amended]

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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]

__._,_.___

"Keep on, Keepin' on"

Dan Cedusky, Champaign IL "Colonel Dan"

See my web site at:

http://www.angelfire.com/il2/VeteranIssues/