Daily Rules, Proposed Rules, and Notices of the Federal Government
This proposed amendment is necessary to implement a decision by the Secretary of Veterans Affairs to clarify and expand the terminology regarding presumption of service connection for peripheral neuropathy associated with exposure to certain herbicide agents.
As required by the Agent Orange Act of 1991, codified in part at 38 U.S.C. 1116, the Department of Veterans Affairs (VA) asks the National Academy of Sciences (NAS) to evaluate scientific literature regarding possible associations between the occurrence of a disease in humans and exposure to an herbicide agent. Congress mandated that NAS to the extent possible determine (1) Whether there is a statistical association between exposure to herbicide agents and the illness, taking into account the strength of the scientific evidence and the appropriateness of the scientific methodology used to detect the association; (2) the increased risk of illness among individuals exposed to herbicide agents during service in the Republic of Vietnam during the Vietnam era; and (3) whether a plausible biological mechanism or other evidence of a causal relationship exists between exposure to the herbicides and the illness. That statute provides that whenever the Secretary determines, based on sound medical and scientific evidence, that a positive association (i.e., the credible evidence for the association is equal to or outweighs the credible evidence against the association) exists between an illness and exposure to herbicide agents in an herbicide used in support of U.S. military operations in the Republic of Vietnam, the Secretary will publish regulations establishing presumptive service connection for that illness.
On September 29, 2011, NAS publicly released the report titled,
Compared to previous reports, a notable change is the NAS decision to revise and clarify the description of the types of peripheral neuropathy that may be associated with exposure to an herbicide agent to include all early-onset peripheral neuropathies, regardless of whether they are transient or persistent in nature. In 1996, NAS found that there was “limited/suggestive evidence” of an association between herbicide exposure and the occurrence of “acute and subacute transient peripheral neuropathy.” In subsequent updates, NAS continued to find “limited or suggestive evidence” of an association between herbicide exposure and that condition, but in 2004, NAS revised its description of the condition to “early onset transient peripheral neuropathy.” This terminology reflected NAS's judgment that peripheral neuropathy associated with herbicide exposure would have its onset proximate in time to herbicide exposure and would be of a transient nature that would resolve over time. Pursuant to the 1996 NAS Report, VA established a regulatory presumption of service connection for “acute and subacute peripheral neuropathy,” which is defined as “transient peripheral neuropathy that appears within weeks or months of exposure to an herbicide agent and resolves within two years of the date of onset.”
As stated above, VA's current regulation presumes service connection for “acute and subacute peripheral neuropathy” which the regulation defines as “transient peripheral neuropathy that appears within weeks or months of exposure to an herbicide agent and resolves within two years of the date of onset.” After careful review of NAS' conclusions, VA proposes to replace the terms “acute and subacute” in 38 CFR 3.309(e) with the term “early-onset” and remove the Note to the regulation requiring that the neuropathy be “transient.” Accordingly, VA proposes to remove the current requirement that acute and subacute peripheral neuropathy appear “within weeks or months” after exposure and remove the requirement that the condition resolve within two years of the date of onset in order for the presumption to apply.
For purposes of consistency, VA further proposes to replace the terms “acute and subacute” with “early-onset” in 38 CFR 3.307(a)(6)(ii) requiring peripheral neuropathy to become manifest to a degree of 10 percent or more within one year after the last date of herbicide exposure in order to be subject to presumptive service connection under 38 CFR 3.309(e).
This amendment would clarify that presumptive service connection for early-onset peripheral neuropathy will not be denied solely because the peripheral neuropathy persisted for more than two years after the date of last herbicide exposure. However, this amendment would not change the current requirement that peripheral neuropathy must have become manifest to a degree of 10 percent or more within one year after the date of last exposure in order to qualify for the presumption of service connection. In Update 2010, the NAS found that evidence did not indicate an association between herbicide exposure and delayed-onset peripheral neuropathy, which NAS defined as peripheral neuropathy having its onset more than one year after exposure.
The one-year presumption period in 38 CFR 3.307(a)(6)(ii) is measured from the date of last herbicide exposure in service. In many cases, such as those based on service in the Republic of Vietnam during the Vietnam era, this would require evidence that peripheral neuropathy was manifest to a degree of ten percent or more during a period several years or decades in the past. Under 38 U.S.C. 1110, VA may pay disability compensation for disability resulting from a service-connected disease or injury. In adjudicating individual claims for benefits, it may therefore be necessary to determine whether evidence shows that current disability exists as a result of the service-connected peripheral neuropathy that was manifest within the presumption period. VA will develop and decide these issues on a case-by-case basis in accordance with established law.
Additionally, we propose to revise 38 CFR 3.816(b)(2), the regulation governing retroactive awards for certain diseases associated with herbicide exposure as required by court orders in the class action litigation in the case of
This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
The Secretary hereby certifies that this proposed 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 proposed rule would not affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this proposed rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires 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 this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866 because it raises novel legal or policy issues.
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 proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.
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.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on April 5, 2012, for publication.
Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam.
For the reasons set out in the preamble, VA proposes to amend 38 CFR part 3 as follows:
1. The authority citation for part 3, subpart A continues to read as follows:
38 U.S.C. 501(a), unless otherwise noted.
2. In § 3.307(a)(6)(ii), remove the term “acute and subacute peripheral neuropathy” and add, in its place, “early-onset peripheral neuropathy”.
3. Amend § 3.309(e) by:
a. Removing the term “Acute and subacute peripheral neuropathy” and adding, in its place, “Early-onset peripheral neuropathy”.
b. Removing Note 2.
c. Redesignating Note 3 as Note 2.
4. Amend § 3.816(b)(2) by:
a. In the introductory text, removing “before October 1, 2002.”
b. In the introductory text, removing the period after “chloracne” and all that follows through the end of the introductory text and adding, in its place, “, as provided in § 3.309(e).”
c. Removing paragraphs (i) through (ix).