final rule: disease associated with exposure to certain herbicide agents: peripheral neuropathy

7/29/2019 FINAL RULE: Disease Associated With Exposure to Certain Herbicide Agents: Peripheral Neuropathy

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54763Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Rules and Regulations

2State and local laws may change and that canaffect the timeliness of a claim. It is advisable forindividuals to contact the FEP agency to confirmcoverage, or otherwise determine that the abovedesignation reflects the current status of the agencyunder state and local law.

flexibility analysis is not required.Moreover, the Regulatory FlexibilityAct, 5 U.S.C. 601 et seq., only requiresa regulatory flexibility analysis whenthe agency is required to issue the ruleafter notice and comment by theAdministrative Procedure Act or anyother law. The EEOC has concluded thatnotice and comment are not required

(see APA above).

Unfunded Mandates Reform Act of 1995

This final rule will not result in theexpenditure by State, local, or tribalgovernments in the aggregate, or by theprivate sector, of $100 million or morein any one year, and it will notsignificantly or uniquely affect smallgovernments. Therefore, no actions aredeemed necessary under the provisionsof the Unfunded Mandates Reform Actof 1995.

Congressional Review Act

This is not a major rule under theCongressional Review Act. TheCommission has otherwise compliedwith the Acts requirements bysubmitting this final rule to Congressprior to its effective date.

List of Subjects in 29 CFR Parts 1601

Administrative practice andprocedure, Equal employmentopportunity, Intergovernmentalrelations.

For the Commission.

Dated: August 29, 2013.

Jacqueline A. Berrien,

Chair.

Accordingly, the Equal EmploymentOpportunity Commission amends 29CFR part 1601 as follows:

PART 1601PROCEDURALREGULATIONS

1. The authority citation for Part 1601continues to read as follows:

Authority: 42 U.S.C. 2000 to 2000e17; 42U.S.C. 12111 to 12117; 42 U.S.C. 2000ff11.

2. In 1601.74, redesignate footnotes2 through 12 as 3 through 13, add anintroductory paragraph, and revisenewly redesignated footnote 6 to read asfollows:

1601.74 Designated and notice agencies.

The Commission has made thefollowing designations 2:

* * * * *

6The Commonwealth of Puerto RicoDepartment of Labor has beendesignated as a FEP agency for allcharges except charges alleging a laborunion has violated title VII; chargesalleging an employment agency hasviolated title VII; and charges allegingviolations of title VII by agencies orinstrumentalities of the Government of

Puerto Rico when they are not operatingas private businesses or enterprises. Forthese types of charges it shall be deemeda Notice Agency, pursuant to 29 CFR1601.71(b). With respect to chargesalleging retaliation under section 704(a)of Title VII, the Commonwealth ofPuerto Rico Department of Labor is aFEP agency for charges allegingretaliation for having opposed unlawfulsexual harassment or participated in astatutory sexual harassment complaintproceeding and a Notice Agency forall other charges alleging violation ofsection 704(a) of Title VII.

* * * * *[FR Doc. 201321545 Filed 9513; 8:45 am]

BILLING CODE 657001P

DEPARTMENT OF VETERANSAFFAIRS

38 CFR Part 3

RIN 2900AO32

Disease Associated With Exposure toCertain Herbicide Agents: PeripheralNeuropathy

AGENCY

: Department of Veterans Affairs.ACTION: Final rule.

SUMMARY: The Department of VeteransAffairs (VA) adopts as a final rule itsproposal to amend its adjudicationregulations by clarifying and expandingthe terminology regarding presumptiveservice connection for acute andsubacute peripheral neuropathyassociated with exposure to certainherbicide agents. This amendmentimplements a decision by the Secretaryof Veterans Affairs based on findingsfrom the National Academy of Sciences(NAS) Institute of Medicine report,Veterans and Agent Orange: Update2010. It also amends VAs regulationgoverning retroactive awards for certaindiseases associated with herbicideexposure as required by court orders inthe class action litigation ofNehmerv.U.S. Department of Veterans Affairs.

DATES: Effective Date:This rule iseffective September 6, 2013.

Applicability Date:This final ruleshall apply to claims received by VA onor after September 6, 2013 and to claimspending before VA on that date.

Additionally, VA will apply this rule inreadjudicating certain previously deniedclaims as required by court orders inNehmerv. Department of VeteransAffairs.

FOR FURTHER INFORMATION CONTACT: Dr.Nick Olmos-Lau, Medical Officer,Regulations Staff (211D), or NancyCopeland, Consultant, CompensationService, Veterans BenefitsAdministration, Department of VeteransAffairs, 810 Vermont Avenue NW.,Washington, DC 20420, (202) 4619700.(This is not a toll-free number.)SUPPLEMENTARY INFORMATION: Asrequired by the Agent Orange Act of1991, 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 literatureregarding possible associations betweenthe occurrence of a disease in humansand exposure to an herbicide agent.Congress mandated that NAS to the

extent possible determine (1) Whetherthere is a statistical association betweenexposure to herbicide agents and theillness, taking into account the strengthof the scientific evidence and theappropriateness of the scientificmethodology used to detect theassociation; (2) the increased risk ofillness among individuals exposed toherbicide agents during service in theRepublic of Vietnam during the Vietnamera; and (3) whether a plausible

biological mechanism or other evidenceof a causal relationship exists betweenexposure to the herbicides and the

illness. That statute provides thatwhenever the Secretary determines,based on sound medical and scientificevidence, that a positive association(i.e., the credible evidence for theassociation is equal to or outweighs thecredible evidence against theassociation) exists between an illnessand exposure to herbicide agents in anherbicide used in support of U.S.military operations in the Republic ofVietnam, the Secretary will publishregulations establishing presumptiveservice connection for that illness. OnAugust 10, 2012, VA published a

proposed rule in the Federal Register(77 FR 47795), to amend its adjudicationregulations regarding presumptiveservice connection for acute andsubacute peripheral neuropathyassociated with exposure to certainherbicide agents. Specifically, based onfindings from the September 29, 2010NAS report titled, Veterans and AgentOrange: Update 2010 (hereinafterUpdate 2010), which concluded thatearly-onset peripheral neuropathyassociated with herbicide exposure isnot necessarily a transient condition, we

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54764 Federal Register / Vol. 78, No. 173 / Friday, September 6, 2013 / Rules and Regulations

proposed replacing the terms acute andsubacute in 38 CFR 3.307(a)(6)(ii) and38 CFR 3.309(e) with the term early-onset and removing the Note to 38 CFR3.309(e) requiring that the neuropathy

be transient. This change wouldremove the requirement that acute andsubacute peripheral neuropathy appearwithin weeks or months after

exposure and that the condition resolvewithin two years of the date of onset inorder for the presumption to apply.

This amendment clarifies that VA willnot deny presumptive serviceconnection for early-onset peripheralneuropathy solely because the conditionpersisted for more than two years afterthe date of the last herbicide exposure.However, it does not change therequirement that peripheral neuropathymust have become manifest to a degreeof ten percent or more within one yearafter the veterans last in-serviceexposure in order to qualify for the

presumption of service connection. InUpdate 2010, NAS found that evidencedid not support an association betweenherbicide exposure and delayed-onsetperipheral neuropathy, which NASdefined as having its onset more thanone year after exposure.

We also proposed amending 38 CFR3.816(b)(2), the regulation governingretroactive awards for certain diseasesassociated with herbicide exposure asrequired by court orders in the classaction litigation in Nehmerv. U.S.Veterans Admin. 712 F. Supp. 1404(N.D. Cal. 1989) (incorporating FinalStipulation and Order, May 14, 1991)

(Nehmer I), enforced, Nehmerv. U.S.Veterans Admin., 32 F. Supp. 2d 1175(N.D. Cal. 1999) (Nehmer II), affd subnom., Nehmerv. Veterans Admin. ofGovt of U.S., 284 F.3d 1158 (9th Cir.2002) (Nehmer III); Nehmerv. U.S.Dept of Veterans Affairs, 494 F.3d 846,850 (9th Cir. 2007) (Nehmer IV).

Currently, the regulation states thatthe Nehmercourt orders apply topresumptions established beforeOctober 1, 2002, and lists the diseasescovered by those presumptions,including acute and subacuteperipheral neuropathy. The courts

invalidated the date restriction andcorresponding listing of presumptiveconditions because they were notinclusive of all the conditions VA hasdetermined to be presumptively serviceconnected based on herbicide exposureunder the Agent Orange Act of 1991.Rather than revising and maintainingseparate lists of diseases covered, VA isremoving the list of conditions in 38CFR 3.816 and the October 1, 2002, dateand inserting language clarifying thatthe Nehmercourt orders apply to thepresumptions listed in 38 CFR 3.309(e).

We provided a 60-day commentperiod and interested persons wereinvited to submit comments on or beforeOctober 9, 2012. We received 111written comments, including 3 fromVeterans Service Organizations andadvocacy groups.

The majority of commentersexpressed support for VAs proposed

amendments. However, many felt thatthe action does not go far enough andurged VA to eliminate the requirementthat peripheral neuropathy manifest to adegree of at least ten percent disablingwithin the first year after the veteranslast in-service exposure to herbicides.VA appreciates these comments.However, in Update 2010, NASconcluded that there is inadequate orinsufficient evidence to determinewhether there is an association betweenexposure to herbicides (including AgentOrange) and delayed-onset chronicneuropathy. NAS reaffirmed the

conclusion in each of its prior reportsthat there are no data to suggest thatexposure to herbicides can lead to thedevelopment of delayed-onset chronicperipheral neuropathy many years aftertermination of exposure in those whodid not originally experience early-onsetneuropathy. NAS went on to state that[t]he committee considers aneuropathy to be early onset ifabnormalities appear within a year afterexternal exposure has ended.Therefore, we make no changes basedon these comments.

Several commenters advocated thatVA expand the list of presumptive

conditions for veterans exposed toAgent Orange. Some asserted thatveterans exposed to Agent Orangeduring service should be grantedentitlement to service connection for alldisabilities they currently have and onecommenter stated that all Vietnam eraveterans should be automaticallyentitled to 100 percent compensation. Aservice organization urged thathypertension be added based on the

benefit of the doubt doctrine. Theorganization contends that, becausesome studies link hypertension toherbicide exposure while others do not,

the evidence is in equipoise andveterans should be given the benefit ofthe doubt. Another service organizationasserted that VAs proposed rule fails toprovide the most favorableinterpretation of the existing science.

In response, VA notes that the AgentOrange Act of 1991, codified at 38U.S.C. 1116, established a deliberateprocess for determining when a diseaseshould be added. Specifically, theSecretary must determine, based onsound medical and scientific evidence,that there is a positive association

between an illness and exposure toherbicide agents used in support of U.S.military operations in the Republic ofVietnam. The Secretary must take intoaccount reports from NAS and all othersound medical and scientificinformation and analyses available tothe Secretary. In evaluating any study,the Secretary must take into

consideration whether the results arestatistically significant, are capable ofreplication, and withstand peer review.The law further provides that a positiveassociation exists if the credibleevidence for the association is equal toor outweighs the credible evidenceagainst the association. VA adheres tothis process. Following the issuance ofUpdate 2010, VA issued a negativenotice on August 10, 2012, explainingwhy no additional diseases were beingadded to its list of conditions associatedwith exposure to herbicides in Vietnam(77 FR 47924). This notice provided an

explanation of VAs decision to notcreate presumptions of serviceconnection for a variety of otherdiseases, including hypertension. Thisrulemaking is limited to clarifying andexpanding the terminology regardingpresumptive service connection foracute and subacute peripheralneuropathy associated with exposure tocertain herbicides. See 77 FR 47795. Assuch, the addition of diseases other thanearly-onset peripheral neuropathy toVAs presumptive list is beyond thescope of this rulemaking. Therefore, wemake no changes based on thesecomments.

Three commenters, including oneservice organization, urged VA torecognize chronic delayed-onsetperipheral neuropathy as due to AgentOrange exposure when no other causecan be established. As explained earlier,NAS found that there are no data tosuggest that exposure to herbicides canlead to the development of delayed-onset chronic peripheral neuropathymany years after termination ofexposure in those who did notoriginally experience early-onsetneuropathy. NAS also noted that someneuropathies are often labeled as

idiopathic or of unknown orspontaneous origin because, in 30percent of the cases of chronicneuropathies, there is no apparentcause. Therefore, we make no changes

based on these comments.We received many comments from

veterans who served in the Republic ofVietnam regarding their individualclaims for veterans benefits andcomments from family members andfriends in support of veterans whoserved in the Republic of Vietnam.These comments are beyond the scope



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of this rulemaking. Therefore, VA makesno changes based on these comments.

Some commenters, including oneservice organization, support the rule

but advocate for more research andpoint to other entities and studies asadditional resources. The serviceorganization also urged VA to fundwell-designed epidemiologic studies of

Vietnam veterans. VA acknowledges theneed for ongoing research and continuesto carefully evaluate ongoing NASherbicide exposure studies, medical andscientific research findings, discoveries,and recommendations as they occur. Inaddition, VA conducts ongoing researchon the health effects of herbicides andsupports epidemiologic studies ofVietnam veterans through grants tooutside scientists. We make no changes

based on these comments.One commenter disagreed with VAs

proposed rule, stating that he is not aveteran and that he was diagnosed withperipheral neuropathy as the result ofshingles. VA recognizes that peripheralneuropathy is not unique to veterans orexposure to Agent Orange. However, asexplained above, pursuant to the AgentOrange Act of 1991, whenever theSecretary determines, based on soundmedical and scientific evidence, thatthere is a positive association (i.e., thecredible evidence for the association isequal to or outweighs the credibleevidence against the association)

between an illness and exposure toherbicide agents, the Secretary willpublish regulations establishingpresumptive service connection for that

illness. Thus, VA makes no changesbased on this comment.

One commenter suggested that VAshould add a regulatory discoveryrule to the current requirement thatperipheral neuropathy become manifestto a degree of ten percent or morewithin one year after the veterans lastin-service exposure. The commenterclarified that his proposed discoveryrule would provide for a tolling of thecurrent one-year manifestationrequirement until after the veteran isfirst diagnosed with peripheralneuropathy (i.e., the veteran first

discovers that he or she hasperipheral neuropathy). The commenterasserted that adding a discovery ruleto the one-year period would give reliefto veterans with peripheral neuropathywhose symptoms were not recognizeduntil many years after exposure whilealso balancing cost concerns. Inresponse, VA notes that the existingstatutory and regulatory frameworkgoverning the administration of VAcompensation benefits does not limitthe time period during which veteransmay file claims for benefits. Moreover,

whether a condition became manifest toa degree of ten percent or more withinone year of the veterans last in-serviceexposure to herbicides is a factualdetermination that must be made on acase-by-case basis, considering all theavailable evidence. Additionally, even ifa veteran is not able to avail himself ofthe presumption of service connection,

he may still be able to establish serviceconnection on a direct basis under 38U.S.C. 1110 and 38 CFR 3.303(d). To theextent the comment recommendschanges to VAs overall scheme foradministering benefits, such changeswould require legislation which is

beyond the scope of this rulemaking.Thus, VA makes no changes based onthis comment.

One commenter stated that he hadtype 2 diabetes and asked why a timelimit is being imposed on the onset ofperipheral neuropathy, given that it mayresult from type 2 diabetes that arises

many years after the initial diagnosis ofthat condition. Several othercommenters also stated that they haddiabetes and asserted that they should

be able to receive compensation for bothdiabetes and peripheral neuropathy.These commenters may be confused asto how the peripheral neuropathypresumption relates to cases whereperipheral neuropathy arises secondaryto service-connected type 2 diabetes. Insuch cases, service connection can beawarded under 38 CFR 3.310 if theperipheral neuropathy is found to besecondary to service-connected type 2diabetes. As a result, the early onset

time limitation contained in theamended 38 CFR 3.307(a)(6)(ii), wouldnot apply to these cases.

One organization commented thatthere is a disparity between the law andactual practice and stated that the Boardof Veterans Appeals has considered thelatent nature of peripheral neuropathyand found in favor of disabled veteranson many occasions. Decisions of theBoard are not considered precedentialand are binding only with regard to thespecific case addressed in eachdecision. Moreover, as discussed above,determinations regarding entitlement to

service connection are made on anindividual basis, dependent on the factsof each case. Even if a veteran is unableto avail himself of the presumptionafforded by 38 U.S.C. 1116, he may still

be able to establish entitlement on adirect basis. This is particularlyimportant when there is an approximate

balance of positive and negativeevidence in a claimants particular case

because a claimant is entitled to thebenefit of the doubt. (38 U.S.C. 5107(b))The fact that VA has made favorabledeterminations underscores its

adherence to this principle whendeciding the merits of each case. VAmakes no changes based on thiscomment.

One organization stated that using theterm early-onset in 38 CFR3.307(a)(6)(ii) is unnecessary andconfusing because the requirement inthat regulation that the disease be

manifest to a ten percent degree withinone year of exposure is sufficient toindicate that the presumption appliesonly to early-onset peripheralneuropathy. However, we believe thatusing the term early-onset peripheralneuropathy is necessary and helpful in38 CFR 3.309(e), which lists the diseasespresumptively associated with herbicideexposure, and we believe that usingconsistent terminology in 38 CFR3.307(a)(6)(ii) and 3.309(e) willminimize confusion rather than creatingit. The commenter also asserted that thechanges to 38 CFR 3.816(b)(2) are

unrelated to NAS findings regardingperipheral neuropathy and that cross-referencing between 38 CFR 3.816 and38 CFR 3.309 appears to obfuscate thediseases that receive a presumptiveservice connection and may serve toundermine the Agent Orange Act of1991. We have considered the languageused and believe it is clear and accurate.As explained in the proposed rule, weare revising 3.816(b)(2) to comport withthe Nehmercourt orders and believethat cross-referencing 38 CFR 3.816 and38 CFR 3.309 will simplify updating thelist of diseases covered. This revisionwill clarify that Nehmercourt ordersapply to all presumptive conditionscovered by 3.309(e). As such, we makeno change based on these comments.

Based on the rationale set forth in theproposed rule and this document, weare adopting the proposed rule as a finalrule with no changes.

Administrative Procedure Act

The Secretary finds good cause todispense with the delayed-effective-daterequirement of 5 U.S.C. 553(d) because38 U.S.C. 1116 (c)(2) requires that finalregulations establishing presumptions ofservice connection for diseases

associated with exposure to certainherbicide agents shall be effective onthe date of issuance.

Paperwork Reduction Act

This document contains no provisionsconstituting a new collection ofinformation under the PaperworkReduction Act (44 U.S.C. 35013521).

Regulatory Flexibility Act

The Secretary hereby certifies thatthis rule will not have a significanteconomic impact on a substantial



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number of small entities as they aredefined in the Regulatory FlexibilityAct, 5 U.S.C. 601612. This rule will notaffect any small entities. Only VA

beneficiaries could be directly affected.Therefore, pursuant to 5 U.S.C. 605(b),this rule is exempt from the initial andfinal regulatory flexibility analysisrequirements of sections 603 and 604.

Executive Order 12866 and 13563

Executive Orders 12866 and 13563direct agencies to assess the costs and

benefits of available regulatoryalternatives and, when regulation isnecessary, to select regulatoryapproaches that maximize net benefits(including potential economic,environmental, public health and safetyeffects, and other advantages;distributive impacts; and equity).Executive Order 13563 (ImprovingRegulation and Regulatory Review)emphasizes the importance ofquantifying both costs and benefits,reducing costs, harmonizing rules, andpromoting flexibility. Executive Order12866 (Regulatory Planning andReview) defines a significantregulatory action, which requiresreview by the Office of Management andBudget (OMB), as any regulatory actionthat is likely to result in a rule that may:(1) Have an annual effect on theeconomy of $100 million or more oradversely affect in a material way theeconomy, a sector of the economy,productivity, competition, jobs, theenvironment, public health or safety, or

State, local, or tribal governments orcommunities; (2) Create a seriousinconsistency or otherwise interferewith an action taken or planned byanother agency; (3) Materially alter the

budgetary impact of entitlements,grants, user fees, or loan programs or therights and obligations of recipientsthereof; or (4) Raise novel legal or policyissues arising out of legal mandates, thePresidents priorities, or the principlesset forth in this Executive Order.

The economic, interagency,budgetary, legal, and policyimplications of this final rule have been

examined and it has been determined tobe a significant regulatory action underExecutive Order 12866 because it raisesnovel legal or policy issues.

VAs impact analysis can be found asa supporting document at http://www.regulations.gov,usually within 48hours after the rulemaking document ispublished. Additionally, a copy of therulemaking and its impact analysis areavailable on VAs Web site at http://www1.va.gov/orpm/,by following thelink for VA Regulations Published.

Unfunded Mandates

The Unfunded Mandates Reform Actof 1995 requires, at 2 U.S.C. 1532, thatagencies prepare an assessment ofanticipated costs and benefits beforeissuing any rule that may result in theexpenditure by State, local, and tribalgovernments, in the aggregate, or by theprivate sector, of $100 million or more(adjusted annually for inflation) in anyyear. This rule will have no such effecton State, local, and tribal governments,or on the private sector.

Catalog of Federal Domestic AssistanceNumbers and Titles

The Catalog of Federal DomesticAssistance program number and title forthis rule is 64.109, VeteransCompensation for Service-ConnectedDisability.

Signing Authority

The Secretary of Veterans Affairs, or

designee, approved this document andauthorized the undersigned to sign andsubmit the document to the Office of theFederal Register for publicationelectronically as an official document ofthe Department of Veterans Affairs. JoseD. Rojas, Interim Chief of Staff,approved this document on April 22,2013, for publication.

List of Subjects in 38 CFR Part 3

Administrative practice andprocedure, Claims, Disability benefits,Health care, Pensions, Radioactivematerials, Veterans, Vietnam.

Dated: September 3, 2013.

Robert C. McFetridge,

Director of Regulations Policy andManagement, Office of the General Counsel,Department of Veterans Affairs.

For the reasons set out in thepreamble, VA amends 38 CFR part 3 asfollows:

PART 3ADJUDICATION

Subpart APension, Compensation,and Dependency and IndemnityCompensation

1. The authority citation for part 3,

subpart A continues to read as follows:Authority: 38 U.S.C. 501(a), unless

otherwise noted.

3.307 [Amended]

2. In 3.307(a)(6)(ii), remove the termacute and subacute peripheralneuropathy and add, in its place,early-onset peripheral neuropathy.

3.309 [Amended]

3. Amend 3.309(e) by: a. Removing the term Acute andsubacute peripheral neuropathy and

adding, in its place, Early-onsetperipheral neuropathy.b. Removing Note 2. c. Redesignating Note 3 as Note 2.

3.816 [Amended]

4. Amend 3.816 by: a. In the introductory text ofparagraph (b)(2), removing before

October 1, 2002.b. In the introductory text ofparagraph (b)(2), removing the periodafter chloracne and the phrase Thosediseases are: and adding, in their place,, as provided in 3.309(e). c. Removing paragraphs (b)(2)(i)through (ix).

[FR Doc. 201321674 Filed 9513; 8:45 am]

BILLING CODE 832001P

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Parts 60 and 62

[EPAHQOAR20110405 and EPAHQOAR20060534; FRL- 98023]

RIN 2060AR11 and RIN 2060A004

Federal Plan Requirements forHospital/Medical/Infectious WasteIncinerators Constructed On or BeforeDecember 1, 2008, and Standards ofPerformance for New StationarySources: Hospital/Medical/InfectiousWaste Incinerators

Correction

In rule document 201309427appearing on pages 2805228078 in theissue of Monday, May 13, 2013, makethe following correction:

62.14470 [Corrected]

1. On page 28074, in the third column,in the fifth line, May 13, 2016 shouldread August 13, 2013.

[FR Doc. C1201309427 Filed 9513; 8:45 am]

BILLING CODE 150501D

DEPARTMENT OF HOMELANDSECURITY

Federal Emergency ManagementAgency

44 CFR Part 64

[Docket ID FEMA20130002; InternalAgency Docket No. FEMA8297]

Suspension of Community Eligibility

AGENCY: Federal EmergencyManagement Agency, DHS.

ACTION: Final rule.

http://www.regulations.gov/http://www.regulations.gov/http://www1.va.gov/orpm/http://www1.va.gov/orpm/http://www1.va.gov/orpm/http://www1.va.gov/orpm/http://www.regulations.gov/http://www.regulations.gov/

final rule: disease associated with exposure to certain herbicide agents: peripheral neuropathy

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