Disease Associated With Exposure to Certain Herbicide Agents: Peripheral Neuropathy, 47795-47797 [2012-19634]

Download as PDF Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Proposed Rules DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900–AO32 Disease Associated With Exposure to Certain Herbicide Agents: Peripheral Neuropathy Department of Veterans Affairs. Proposed rule. AGENCY: ACTION: The Department of Veterans Affairs (VA) proposes to amend its adjudication regulation concerning presumptive service connection for acute and sub-acute peripheral neuropathy associated with exposure to certain herbicide agents. 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. DATES: Comments must be received by VA on or before October 9, 2012. ADDRESSES: Written comments may be submitted through https:// www.regulations.gov; by mail or handdelivery to Director, Regulations Management (02REG), Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1068, Washington, DC 20420; or by fax to (202) 273–9026. (This is not a toll free number). Comments should indicate that they are submitted in response to ‘‘RIN 2900– AO32—Disease Associated With Exposure to Certain Herbicide Agents: Peripheral Neuropathy.’’ Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461–4902 for an appointment. (This is not a toll free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System at https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Dr. Nick Olmos-Lau, Medical Officer, Regulations Staff (211D), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–9695. (This is not a toll free number.) SUPPLEMENTARY INFORMATION: As required by the Agent Orange Act of 1991, codified in part at 38 U.S.C. 1116, the Department of Veterans Affairs (VA) tkelley on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:46 Aug 09, 2012 Jkt 226001 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, Veterans and Agent Orange: Update 2010, which describes the law mandating the NAS review and highlights of the ninth biennial update. In Update 2010, NAS conducted a comprehensive search of all medical and scientific studies on health effects of herbicides used in the Vietnam War, including more than 6,600 potentially relevant studies, of which 1,300 were carefully reviewed, and about 65 ultimately contributed new information. Relevant animal studies, as with previous biennial ‘‘Agent Orange Updates,’’ were also reviewed to determine biological plausibility and possible mechanisms of action. 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 earlyonset 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 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 47795 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.’’ In Update 2010, NAS concluded that there is ‘‘limited or suggestive evidence of an association’’ between exposure to the chemicals of interest and ‘‘earlyonset peripheral neuropathy that may be persistent.’’ This description reflects NAS’ decision to remove the term ‘‘transient’’ from the description of the peripheral neuropathies associated with herbicide exposure. In Update 2010, NAS reexamined several studies reviewed in prior NAS reports concerning early-onset peripheral neuropathy in individuals exposed to herbicides and found that, in several of the studies, some exposed individuals continued to exhibit neurological symptoms several years after exposure. NAS explained that, for the purpose of identifying peripheral neuropathies related to herbicide exposure, the diagnosis of the condition is contingent upon the proximity of the disease onset to the exposure, rather than upon the adverse outcome having a transitory nature. NAS stated that, in cases of an immediate response of peripheral neuropathy following a toxic exposure, stabilization or improvement is the rule after exposure ends, but that the recovery may not be complete and the degree of recovery can depend on the severity of the initial impairment and the particular exposure. NAS further noted that there may be persistent subclinical effects that are not immediately apparent but that may be detected by detailed examination and testing. Accordingly, NAS concluded that early-onset peripheral neuropathy associated with herbicide exposure is not necessarily a transient condition. However, NAS reaffirmed the conclusion in each of its prior reports that no data suggests that exposure to the chemicals of interest can lead to the development of delayed-onset chronic E:\FR\FM\10AUP1.SGM 10AUP1 tkelley on DSK3SPTVN1PROD with PROPOSALS 47796 Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Proposed Rules neuropathy many years after termination of exposure in those who did not originally experience early-onset neuropathy. 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 ‘‘earlyonset’’ 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 ‘‘earlyonset’’ 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. VerDate Mar<15>2010 17:46 Aug 09, 2012 Jkt 226001 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-bycase 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 Nehmer v. U.S. Department of Veterans Affairs. Currently § 3.816(b)(2) states that the Nehmer court orders apply to presumptions established before October 1, 2002, and lists the diseases covered by those presumptions, including ‘‘acute and subacute peripheral neuropathy.’’ Rather than revising this list, we propose to remove the list of conditions and the October 1, 2002, date and insert language clarifying that the Nehmer court orders apply to the presumptions listed in § 3.309(e). This change is necessary because the district court and the U.S. Court of Appeals for the Ninth Circuit in Nehmer found the date restriction and the corresponding listing of presumptive conditions based on herbicide exposure found at § 3.816(b)(2) to be invalid as it is not inclusive of all conditions the Secretary has determined to be presumptively service connected based on herbicide exposure under the Agent Orange Act of 1991. Therefore, VA proposes to remove paragraphs (b)(2)(i)– (ix) and the phrase ‘‘before October 1, 2002’’ and to add a reference to § 3.309(e) that reflects the inclusive listing in the introduction to paragraph (b)(2). 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 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 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 proposed rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Executive Orders 12866 and 13563 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. 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 proposed rule would have no such effect on State, local, and tribal governments, or on the private sector. E:\FR\FM\10AUP1.SGM 10AUP1 Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Proposed Rules Catalog of Federal Domestic Assistance Numbers and Titles c. Removing paragraphs (i) through (ix). 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. [FR Doc. 2012–19634 Filed 8–9–12; 8:45 am] Signing Authority [EPA–R06–RCRA–2010–0307; FRL–9713–2] 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. Arkansas: Final Authorization of State Hazardous Waste Management Program Revisions List of Subjects in 38 CFR Part 3 Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam. Dated: August 7, 2012. Robert C. McFetridge, Director, Regulation Policy and Management, Office of the General Counsel, Department of Veterans Affairs. For the reasons set out in the preamble, VA proposes to amend 38 CFR part 3 as follows: 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: tkelley on DSK3SPTVN1PROD with PROPOSALS Authority: 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).’’ VerDate Mar<15>2010 17:46 Aug 09, 2012 Jkt 226001 BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The State of Arkansas has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant Final authorization to the State of Arkansas. In the ‘‘Rules and Regulations’’ section of this Federal Register, EPA is authorizing the changes by a direct final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we receive comments that oppose this action, we will withdraw the immediate final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time. DATES: Send your written comments by September 10, 2012. ADDRESSES: Send written comments to Alima Patterson, Region 6, Regional Authorization Coordinator, (6PD–O), Multimedia Planning and Permitting Division, at the address shown below. You can examine copies of the materials submitted by the State of Arkansas during normal business hours at the following locations: Arkansas Department of Environmental Quality, 8101 Interstate 30, Little Rock, Arkansas 72219–8913, (501) 682–0876, and EPA, Region 6, 1445 Ross Avenue, Dallas, Texas 75202–2733, phone number (214) 665–8533; or Comments may also be 47797 submitted electronically or through hand delivery/courier; please follow the detailed instructions in the ADDRESSES section of the immediate final rule which is located in the Rules section of this Federal Register. FOR FURTHER INFORMATION CONTACT: Alima Patterson (214) 665–8533. SUPPLEMENTARY INFORMATION: For additional information, please see the immediate final rule published in the ‘‘Rules and Regulations’’ section of this Federal Register. Dated: July 10, 2012. Samuel Coleman, Acting Regional Administrator, Region 6. [FR Doc. 2012–19306 Filed 8–9–12; 8:45 am] BILLING CODE 6560–50–P SUMMARY: PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Part 19 and 35 [FAR Case 2012–015; Docket 2012–0015; Sequence 1] RIN 9000–AM33 Federal Acquisition Regulation; Small Business Set Asides for Research and Development Contracts Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA). ACTION: Proposed rule. AGENCY: DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to clarify that contracting officers shall set aside acquisitions for research and development, when there is also a reasonable expectation, as a result of market research, that there are small businesses capable of providing the best scientific and technological approaches. DATES: Interested parties should submit written comments to the Regulatory Secretariat at one of the addressees shown below on or before October 9, 2012 to be considered in the formation of the final rule. ADDRESSES: Submit comments in response to FAR Case 2012–015 by any of the following methods: • Regulations.gov: https:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for ‘‘FAR Case 2012–015.’’ Select the link ‘‘Submit a Comment’’ SUMMARY: E:\FR\FM\10AUP1.SGM 10AUP1

Agencies

[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Proposed Rules]
[Pages 47795-47797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19634]



[[Page 47795]]

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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AO32


Disease Associated With Exposure to Certain Herbicide Agents: 
Peripheral Neuropathy

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its 
adjudication regulation concerning presumptive service connection for 
acute and sub-acute peripheral neuropathy associated with exposure to 
certain herbicide agents.
    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.

DATES: Comments must be received by VA on or before October 9, 2012.

ADDRESSES: Written comments may be submitted through https://www.regulations.gov; by mail or hand-delivery to Director, Regulations 
Management (02REG), Department of Veterans Affairs, 810 Vermont Ave. 
NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. 
(This is not a toll free number). Comments should indicate that they 
are submitted in response to ``RIN 2900-AO32--Disease Associated With 
Exposure to Certain Herbicide Agents: Peripheral Neuropathy.'' Copies 
of comments received will be available for public inspection in the 
Office of Regulation Policy and Management, Room 1063B, between the 
hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except 
holidays). Please call (202) 461-4902 for an appointment. (This is not 
a toll free number.) In addition, during the comment period, comments 
may be viewed online through the Federal Docket Management System at 
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Nick Olmos-Lau, Medical Officer, 
Regulations Staff (211D), Compensation Service, Veterans Benefits 
Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., 
Washington, DC 20420, (202) 461-9695. (This is not a toll free number.)

SUPPLEMENTARY INFORMATION: 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, 
Veterans and Agent Orange: Update 2010, which describes the law 
mandating the NAS review and highlights of the ninth biennial update. 
In Update 2010, NAS conducted a comprehensive search of all medical and 
scientific studies on health effects of herbicides used in the Vietnam 
War, including more than 6,600 potentially relevant studies, of which 
1,300 were carefully reviewed, and about 65 ultimately contributed new 
information. Relevant animal studies, as with previous biennial ``Agent 
Orange Updates,'' were also reviewed to determine biological 
plausibility and possible mechanisms of action.
    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.''
    In Update 2010, NAS concluded that there is ``limited or suggestive 
evidence of an association'' between exposure to the chemicals of 
interest and ``early-onset peripheral neuropathy that may be 
persistent.'' This description reflects NAS' decision to remove the 
term ``transient'' from the description of the peripheral neuropathies 
associated with herbicide exposure. In Update 2010, NAS reexamined 
several studies reviewed in prior NAS reports concerning early-onset 
peripheral neuropathy in individuals exposed to herbicides and found 
that, in several of the studies, some exposed individuals continued to 
exhibit neurological symptoms several years after exposure. NAS 
explained that, for the purpose of identifying peripheral neuropathies 
related to herbicide exposure, the diagnosis of the condition is 
contingent upon the proximity of the disease onset to the exposure, 
rather than upon the adverse outcome having a transitory nature. NAS 
stated that, in cases of an immediate response of peripheral neuropathy 
following a toxic exposure, stabilization or improvement is the rule 
after exposure ends, but that the recovery may not be complete and the 
degree of recovery can depend on the severity of the initial impairment 
and the particular exposure. NAS further noted that there may be 
persistent subclinical effects that are not immediately apparent but 
that may be detected by detailed examination and testing. Accordingly, 
NAS concluded that early-onset peripheral neuropathy associated with 
herbicide exposure is not necessarily a transient condition. However, 
NAS reaffirmed the conclusion in each of its prior reports that no data 
suggests that exposure to the chemicals of interest can lead to the 
development of delayed-onset chronic

[[Page 47796]]

neuropathy many years after termination of exposure in those who did 
not originally experience early-onset neuropathy.
    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 Nehmer v. U.S. Department of Veterans 
Affairs. Currently Sec.  3.816(b)(2) states that the Nehmer court 
orders apply to presumptions established before October 1, 2002, and 
lists the diseases covered by those presumptions, including ``acute and 
subacute peripheral neuropathy.'' Rather than revising this list, we 
propose to remove the list of conditions and the October 1, 2002, date 
and insert language clarifying that the Nehmer court orders apply to 
the presumptions listed in Sec.  3.309(e). This change is necessary 
because the district court and the U.S. Court of Appeals for the Ninth 
Circuit in Nehmer found the date restriction and the corresponding 
listing of presumptive conditions based on herbicide exposure found at 
Sec.  3.816(b)(2) to be invalid as it is not inclusive of all 
conditions the Secretary has determined to be presumptively service 
connected based on herbicide exposure under the Agent Orange Act of 
1991. Therefore, VA proposes to remove paragraphs (b)(2)(i)-(ix) and 
the phrase ``before October 1, 2002'' and to add a reference to Sec.  
3.309(e) that reflects the inclusive listing in the introduction to 
paragraph (b)(2).

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 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

    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.

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 proposed rule would have no such effect on 
State, local, and tribal governments, or on the private sector.

[[Page 47797]]

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.

Signing Authority

    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.

List of Subjects in 38 CFR Part 3

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

    Dated: August 7, 2012.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General 
Counsel, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA proposes to amend 38 
CFR part 3 as follows:

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(a)(6)(ii), remove the term ``acute and subacute 
peripheral neuropathy'' and add, in its place, ``early-onset peripheral 
neuropathy''.
    3. Amend Sec.  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 Sec.  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 Sec.  3.309(e).''
    c. Removing paragraphs (i) through (ix).

[FR Doc. 2012-19634 Filed 8-9-12; 8:45 am]
BILLING CODE 8320-01-P
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