Presumption of Herbicide Exposure and Presumption of Disability During Service for Reservists Presumed Exposed to Herbicide, 35246-35249 [2015-14995]

Download as PDF 35246 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Rules and Regulations circle with a 280 foot radius at position 47°07′22″ N, 088°35′39″ W. (b) Effective period. This safety zone is effective from 10 p.m. to 11 p.m. on June 20, 2015. (c) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Duluth, or his designated on-scene representative. (2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Duluth or his designated on-scene representative. (3) The ‘‘on-scene representative’’ of the Captain of the Port is any Coast Guard commissioned, warrant, or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16. (4) Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Duluth or his on-scene representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Duluth or his on-scene representative. Dated: June 10, 2015. A.H. Moore, Jr., Commander, U.S. Coast Guard, Captain of the Port Duluth. [FR Doc. 2015–15188 Filed 6–18–15; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900–AP43 Presumption of Herbicide Exposure and Presumption of Disability During Service for Reservists Presumed Exposed to Herbicide Department of Veterans Affairs. Interim final rule. AGENCY: ACTION: The Department of Veterans Affairs (VA) is amending its regulation governing individuals presumed to have been exposed to certain herbicides. Specifically, VA is expanding the regulation to include an additional group consisting of individuals who performed service in the Air Force or rmajette on DSK2TPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 15:11 Jun 18, 2015 Jkt 235001 Air Force Reserve under circumstances in which they had regular and repeated contact with C–123 aircraft known to have been used to spray an herbicide agent (‘‘Agent Orange’’) during the Vietnam era. In addition, the regulation will establish a presumption that members of this group who later develop an Agent Orange presumptive condition were disabled during the relevant period of service, thus establishing that this service constituted ‘‘active, naval, military or air service.’’ The effect of this action is to presume herbicide exposure for these individuals and to allow individuals who were exposed to herbicides during reserve service to establish veteran status for VA purposes and eligibility for some VA benefits. The need for this action results from a recent decision by the Secretary of Veterans Affairs to acknowledge that individuals who had regular and repeated exposure to C–123 aircraft that the United States Air Force used to spray the herbicides in Vietnam during Operation Ranch Hand were exposed to Agent Orange. DATES: Effective Date: This interim final rule is effective on June 19, 2015. Applicability Dates: This interim final rule is applicable to any claim for service connection for an Agent Orange presumptive condition filed by a covered individual that is pending on or after June 19, 2015. Comment date: Comments must be received on or before August 18, 2015. FOR FURTHER INFORMATION CONTACT: Stephanie Li, Chief, Regulations Staff, Compensation Service (21C), Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420, (202) 461– 9700 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: In 2014, VA commissioned the National Academy of Sciences’ Institute of Medicine (IOM) to conduct a consensus study of all available scientific literature and knowledge on the subject of residual exposure to Agent Orange from service on aircraft formerly used during Operation Ranch Hand in Vietnam. VA commissioned this study to get a better understanding of the potential harmful exposures and health effects involved in serving on these aircraft after the conclusion of herbicide spraying operations in Vietnam. Specifically, VA requested that the IOM ‘‘determine whether there had been exposures that could lead to excess risk of adverse health outcomes among [Air Force] Reserve personnel who flew in and/or maintained C–123 aircraft (outside of Vietnam) that had previously been used to spray Agent Orange.’’ See Institute of PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 Medicine, National Academy of Sciences, Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C–123 Aircraft 10 (2015), available at http:// www.publichealth.va.gov/exposures/ agentorange/publications/institute-ofmedicine.asp. According to the IOM’s 2015 report on C–123 exposures, from 1972 to 1982, approximately 1,500 to 2,100 Air Force Reserve personnel trained and worked on C–123 aircraft, of which approximately 30 had formally been used to spray herbicides in Vietnam. Id. at 9. The report noted that the aircraft had been assigned to a few Air Force Reserve units where they were used for military airlift, medical transport, and cargo transport operations in the United States and internationally. Id. at 26. Regarding the potential for harmful exposures, the IOM found that Reservists who served as flight crew (pilot, navigator, flight engineer, and loadmaster), ground maintenance crew, and aero-medical personnel had regular and repeated contact with the aircraft. Id. at 26–27. The report identified the specific aircraft and the Reserve units to which they were assigned, and concluded, ‘‘it is probable that the [herbicide] exposures of at least some [Air Force] Reservists exceeded levels equivalent to some guidelines established for office workers in enclosed settings.’’ Id. at 62. The IOM determined that it is ‘‘plausible that the C–123s did contribute to some adverse health consequences among [Air Force] Reservists who worked in [Operation Ranch Hand] C–123s after the planes returned from Vietnam.’’ Id. at 62–63. Based upon the IOM report, the Secretary of Veterans Affairs has decided that VA will acknowledge exposure to Agent Orange for approximately 1,500 to 2,100 Air Force and Air Force Reserve personnel whose military service involved regular and repeated contact with the contaminated C–123 aircraft. Therefore, this interim final rule establishes a presumption of exposure to herbicides for individuals who performed service in the Air Force or Air Force Reserve under circumstances in which the individual concerned regularly and repeatedly operated, maintained, or served onboard C–123 aircraft known to have been used to spray an herbicide agent during the Vietnam era. However, most individuals with such service were members of the Air Force Reserve at the time. Basic eligibility for VA benefits requires that an individual be a ‘‘veteran’’ as that term is defined in 38 U.S.C. 101(2): ‘‘The term ‘veteran’ means a person who served in the active military, naval, or air service, and who was discharged or E:\FR\FM\19JNR1.SGM 19JNR1 rmajette on DSK2TPTVN1PROD with RULES Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Rules and Regulations released therefrom under conditions other than dishonorable.’’ Service as a member of a reserve component during a period of active duty for training or inactive duty training does not qualify an individual as a ‘‘veteran’’ because it does not constitute ‘‘active military, naval or air service’’ unless the individual is disabled or dies during that period of service as provided under 38 U.S.C. 101(24)(B) and (C). Pursuant to the Secretary’s general rulemaking authority under 38 U.S.C. 501(a), VA has provided presumptions of service connection for diseases associated with exposure to an herbicide agent. 38 CFR 3.309(e). These presumptions of service connection are consistent with the disease-based presumptions under 38 U.S.C. 1116 for Vietnam Veterans with service in the Republic of Vietnam who are presumed by law to have been exposed to an herbicide agent during such service. Because an individual must quality as a ‘‘veteran’’ before they are eligible for presumptions of service connection, see Smith v. Shinseki, 24 Vet. App. 40, 44 (2010) (noting ‘‘[t]he Court has held that, without previously established veteran status, the presumptions of service connection . . . are inapplicable’’), VA estimates that most of the servicemembers addressed by the IOM report are not presently eligible for the regulatory disease-based presumptions of service connection. This interim final rule establishes factual presumptions that will allow Air Force Reservists who are presumed under this interim final rule to have been exposed to herbicide during their reserve service to establish veteran status as a result of that service. Although section 101(24) requires a period of active duty for training or inactive duty training ‘‘during which the individual concerned was disabled or died’’ for a period of active duty for training or inactive duty training to constitute ‘‘active military, naval, or air service,’’ the latent effects of herbicide exposure were unrecognized when section 101(24) was enacted in 1958. Operation Ranch Hand spraying commenced in 1962 and concluded in 1971, and Congress recognized the need for presumptions of service connection for Agent Orange-related conditions and regular evaluation of the science related to such conditions in the Agent Orange Act of 1991, Public Law 102–4. Pursuant to this law, the IOM in 1992 entered into an agreement with VA to review and summarize scientific evidence concerning the association between herbicide exposure during Vietnam service and conditions that might be associated with such exposure. VerDate Sep<11>2014 15:11 Jun 18, 2015 Jkt 235001 It issued its first report on the subject in 1994. See Institute of Medicine, National Academy of Sciences, Veterans and Agent Orange: Health Effects of Herbicides Used in Vietnam (1994), available at http:// www.publichealth.va.gov/exposures/ agentorange/publications/institute-ofmedicine.asp. Thus, in enacting section 101(24), Congress was necessarily unaware of later scientific understanding of the potential latent effects of herbicide exposure. Indeed, Congress was necessarily informed by the science that existed at the time of enactment in 1958. The legislative history regarding the enactment of section 101(24) does not specifically explain Congress’ intent in requiring that the individual ‘‘was disabled or died’’ during the period of service. It is probable that Congress required a reserve component member to have been disabled ‘‘during’’ training because the medical science of the time understood that, if an in-service injury were to result in disability, at least some aspect of that disability generally would be manifest contemporaneous with the injury. However, subsequent developments with regard to herbicide use in Vietnam and advancements in medical understanding of the health effects of herbicide exposure raise a question regarding the application of section 101(24) to disability associated with such exposure. Viewing the generally beneficial purpose of section 101(24) in light of the evolved medical understanding, we believe it is reasonable to create a factual presumption that disability occurred during the period of service as required under section 101(24) when an individual has a present disability now scientifically associated with exposure to an herbicide agent. Specifically, the existing herbicide-related disease presumptions enumerated in 38 CFR 3.309(e), coupled with the potential for clinical uncertainty regarding when such diseases first manifested, provide a reasonable basis for presuming that disability occurred during a period of reserve service for purposes of satisfying the requirements under section 101(24)(B) or (C) in order to ensure compensation and health care for reservists disabled as a result of herbicide exposure on reserve duty. For the above reasons, we are amending 38 CFR 3.307 regarding disease associated with exposure to certain herbicide agents to add new paragraph (a)(6)(v). As amended, § 3.307 will presume exposure to herbicide for ‘‘[a]n individual who performed service in the Air Force or Air Force Reserve under circumstances in which the PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 35247 individual concerned regularly and repeatedly operated, maintained, or served onboard C–123 aircraft known to have been used to spray an herbicide agent during the Vietnam era.’’ Further, in consideration of the reserve component members with such service, VA will consider this presumed herbicide exposure to be an ‘‘injury’’ under section 101(24)(B) and (C). In turn, if such individual develops a presumptive disease listed in 38 CFR 3.309(e), as specified in 38 CFR 3.307(a)(6)(ii), ‘‘it will be presumed that the individual concerned became disabled during that service for purposes of establishing that the individual has active military, naval, or air service.’’ VA will make the factual presumption that the individual concerned was disabled during the qualifying service so that such individual’s service will constitute ‘‘active, military, naval, or air service.’’ As explained, we believe this is consistent with section 101(24) because herbicide exposure has uniquely latent effects which were largely unrecognized in 1958. Covered individuals may therefore establish veteran status for purposes of VA’s disability compensation, dependency and indemnity compensation, medical care, and burial benefits related to any Agent Orange-related presumptive condition. Administrative Procedure Act The Secretary of Veterans Affairs finds under 5 U.S.C. 553(b)(B) that there is good cause that advance notice and opportunity for public comment are impracticable, unnecessary, or contrary to the public interest and under 5 U.S.C. 553(d)(3) that there is good cause to publish this rule with an immediate effective date. This interim final rule provides a presumption of herbicide exposure for individuals who performed certain military service. This interim final rule also establishes a presumption that if such an individual develops a presumptive herbicide-related condition, the individual concerned became disabled during that service for purposes of establishing that the individual has active military, naval, or air service. These changes will make individuals who were exposed to herbicide during service eligible for some VA benefits for disabilities resulting from herbicide-related diseases. Based on the age of the individuals affected by this rule and the potential severity of the disabilities associated with their herbicide exposure, it is likely that affected individuals will have significant and urgent financial and medical needs. In order for these individuals to have E:\FR\FM\19JNR1.SGM 19JNR1 35248 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Rules and Regulations access to VA benefits to include VA health care, it is essential that these rules be made effective as soon as possible. For the above reasons, the Secretary issues this rule as an interim final rule. However, VA will consider and address comments that are received within 60 days of the date this interim final rule is published in the Federal Register. Paperwork Reduction Act This rule contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501–3521). rmajette on DSK2TPTVN1PROD with RULES Regulatory Flexibility Act Because no notice of proposed rulemaking is required in connection with the adoption of this interim final rule, no regulatory flexibility analysis is required under the Regulatory Flexibility Act, 5 U.S.C. 601–612. Even so, the Secretary of Veterans Affairs certifies that this interim final rule will not directly affect any small entities. It will directly affect only VA beneficiaries. Accordingly, this interim 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. Executive Order 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,’’ requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, 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) VerDate Sep<11>2014 15:11 Jun 18, 2015 Jkt 235001 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 regulatory action have been examined, and it has been determined that it is not an economically significant regulatory action under Executive Order 12866. VA’s regulatory impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its regulatory impact analysis are available on VA’s Web site at http://www.va.gov/ orpm/, by following the link for ‘‘VA Regulations Published From FY 2004 Through Fiscal Year to Date.’’ 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 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 one year. This interim final rule will have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans’ Dependents; 64.104, Pension for Non-ServiceConnected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for ServiceConnected 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 PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, Department of Veterans Affairs, approved this document on May 11, 2015, 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: June 15, 2015. William F. Russo, Acting Director, Office of Regulation Policy & Management, Office of the General Counsel, Department of Veterans Affairs. For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 3 to read 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. Amend § 3.307 by adding paragraph (a)(6)(v) immediately after paragraph (a)(6)(iv) and revising the authority citation at the end of the section to read as follows: ■ § 3.307 Presumptive service connection for chronic, tropical or prisoner-of-war related disease, or disease associated with exposure to certain herbicide agents; wartime and service on or after January 1, 1947. (a) * * * (6) * * * (v) An individual who performed service in the Air Force or Air Force Reserve under circumstances in which the individual concerned regularly and repeatedly operated, maintained, or served onboard C–123 aircraft known to have been used to spray an herbicide agent during the Vietnam era shall be presumed to have been exposed during such service to an herbicide agent. For purposes of this paragraph, ‘‘regularly and repeatedly operated, maintained, or served onboard C–123 aircraft’’ means that the individual was assigned to an Air Force or Air Force Reserve squadron when the squadron was permanently assigned one of the affected aircraft and the individual had an Air Force Specialty Code indicating duties as a flight, ground maintenance, or medical crew member on such aircraft. Such exposure constitutes an injury under 38 E:\FR\FM\19JNR1.SGM 19JNR1 Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Rules and Regulations U.S.C. 101(24)(B) and (C). If an individual described in this paragraph develops a disease listed in 38 CFR 3.309(e) as specified in paragraph (a)(6)(ii) of this section, it will be presumed that the individual concerned became disabled during that service for purposes of establishing that the individual served in the active military, naval, or air service. * * * * * (Authority: 38 U.S.C. 101(24), 501(a), 1116(a)(3), and 1821) [FR Doc. 2015–14995 Filed 6–18–15; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2014–0249; FRL–9928–82] Thiram; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of thiram in or on avocado. Taminco US, Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective June 19, 2015. Objections and requests for hearings must be received on or before August 18, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0249, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, rmajette on DSK2TPTVN1PROD with RULES VerDate Sep<11>2014 15:11 Jun 18, 2015 Jkt 235001 I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? SUMMARY: ADDRESSES: DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2014–0249 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 18, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 35249 by docket ID number EPA–HQ–OPP– 2014–0249, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of December 17, 2014 (79 FR 75107) (FRL–9918–90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8250) by Taminco US, Inc., Two Windsor Plaza, Suite 411, 7540 Windsor Drive, Allentown, PA 18195. The petition requested that 40 CFR 180.132 be amended by establishing a tolerance for residues of the fungicide thiram in or on avocado at 8 parts per million (ppm). That document referenced a summary of the petition prepared by Taminco US, Inc, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. For reasons that are discussed in Unit IV.C., EPA is establishing a tolerance for avocado at 15 ppm. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to E:\FR\FM\19JNR1.SGM 19JNR1

Agencies

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Rules and Regulations]
[Pages 35246-35249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14995]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AP43


Presumption of Herbicide Exposure and Presumption of Disability 
During Service for Reservists Presumed Exposed to Herbicide

AGENCY: Department of Veterans Affairs.

ACTION: Interim final rule.

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

SUMMARY: The Department of Veterans Affairs (VA) is amending its 
regulation governing individuals presumed to have been exposed to 
certain herbicides. Specifically, VA is expanding the regulation to 
include an additional group consisting of individuals who performed 
service in the Air Force or Air Force Reserve under circumstances in 
which they had regular and repeated contact with C-123 aircraft known 
to have been used to spray an herbicide agent (``Agent Orange'') during 
the Vietnam era. In addition, the regulation will establish a 
presumption that members of this group who later develop an Agent 
Orange presumptive condition were disabled during the relevant period 
of service, thus establishing that this service constituted ``active, 
naval, military or air service.'' The effect of this action is to 
presume herbicide exposure for these individuals and to allow 
individuals who were exposed to herbicides during reserve service to 
establish veteran status for VA purposes and eligibility for some VA 
benefits. The need for this action results from a recent decision by 
the Secretary of Veterans Affairs to acknowledge that individuals who 
had regular and repeated exposure to C-123 aircraft that the United 
States Air Force used to spray the herbicides in Vietnam during 
Operation Ranch Hand were exposed to Agent Orange.

DATES: Effective Date: This interim final rule is effective on June 19, 
2015.
    Applicability Dates: This interim final rule is applicable to any 
claim for service connection for an Agent Orange presumptive condition 
filed by a covered individual that is pending on or after June 19, 
2015.
    Comment date: Comments must be received on or before August 18, 
2015.

FOR FURTHER INFORMATION CONTACT: Stephanie Li, Chief, Regulations 
Staff, Compensation Service (21C), Veterans Benefits Administration, 
Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 
20420, (202) 461-9700 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: In 2014, VA commissioned the National 
Academy of Sciences' Institute of Medicine (IOM) to conduct a consensus 
study of all available scientific literature and knowledge on the 
subject of residual exposure to Agent Orange from service on aircraft 
formerly used during Operation Ranch Hand in Vietnam. VA commissioned 
this study to get a better understanding of the potential harmful 
exposures and health effects involved in serving on these aircraft 
after the conclusion of herbicide spraying operations in Vietnam. 
Specifically, VA requested that the IOM ``determine whether there had 
been exposures that could lead to excess risk of adverse health 
outcomes among [Air Force] Reserve personnel who flew in and/or 
maintained C-123 aircraft (outside of Vietnam) that had previously been 
used to spray Agent Orange.'' See Institute of Medicine, National 
Academy of Sciences, Post-Vietnam Dioxin Exposure in Agent Orange-
Contaminated C-123 Aircraft 10 (2015), available at http://www.publichealth.va.gov/exposures/agentorange/publications/institute-of-medicine.asp.
    According to the IOM's 2015 report on C-123 exposures, from 1972 to 
1982, approximately 1,500 to 2,100 Air Force Reserve personnel trained 
and worked on C-123 aircraft, of which approximately 30 had formally 
been used to spray herbicides in Vietnam. Id. at 9. The report noted 
that the aircraft had been assigned to a few Air Force Reserve units 
where they were used for military airlift, medical transport, and cargo 
transport operations in the United States and internationally. Id. at 
26. Regarding the potential for harmful exposures, the IOM found that 
Reservists who served as flight crew (pilot, navigator, flight 
engineer, and loadmaster), ground maintenance crew, and aero-medical 
personnel had regular and repeated contact with the aircraft. Id. at 
26-27. The report identified the specific aircraft and the Reserve 
units to which they were assigned, and concluded, ``it is probable that 
the [herbicide] exposures of at least some [Air Force] Reservists 
exceeded levels equivalent to some guidelines established for office 
workers in enclosed settings.'' Id. at 62. The IOM determined that it 
is ``plausible that the C-123s did contribute to some adverse health 
consequences among [Air Force] Reservists who worked in [Operation 
Ranch Hand] C-123s after the planes returned from Vietnam.'' Id. at 62-
63.
    Based upon the IOM report, the Secretary of Veterans Affairs has 
decided that VA will acknowledge exposure to Agent Orange for 
approximately 1,500 to 2,100 Air Force and Air Force Reserve personnel 
whose military service involved regular and repeated contact with the 
contaminated C-123 aircraft. Therefore, this interim final rule 
establishes a presumption of exposure to herbicides for individuals who 
performed service in the Air Force or Air Force Reserve under 
circumstances in which the individual concerned regularly and 
repeatedly operated, maintained, or served onboard C-123 aircraft known 
to have been used to spray an herbicide agent during the Vietnam era. 
However, most individuals with such service were members of the Air 
Force Reserve at the time. Basic eligibility for VA benefits requires 
that an individual be a ``veteran'' as that term is defined in 38 
U.S.C. 101(2): ``The term `veteran' means a person who served in the 
active military, naval, or air service, and who was discharged or

[[Page 35247]]

released therefrom under conditions other than dishonorable.'' Service 
as a member of a reserve component during a period of active duty for 
training or inactive duty training does not qualify an individual as a 
``veteran'' because it does not constitute ``active military, naval or 
air service'' unless the individual is disabled or dies during that 
period of service as provided under 38 U.S.C. 101(24)(B) and (C).
    Pursuant to the Secretary's general rulemaking authority under 38 
U.S.C. 501(a), VA has provided presumptions of service connection for 
diseases associated with exposure to an herbicide agent. 38 CFR 
3.309(e). These presumptions of service connection are consistent with 
the disease-based presumptions under 38 U.S.C. 1116 for Vietnam 
Veterans with service in the Republic of Vietnam who are presumed by 
law to have been exposed to an herbicide agent during such service. 
Because an individual must quality as a ``veteran'' before they are 
eligible for presumptions of service connection, see Smith v. Shinseki, 
24 Vet. App. 40, 44 (2010) (noting ``[t]he Court has held that, without 
previously established veteran status, the presumptions of service 
connection . . . are inapplicable''), VA estimates that most of the 
servicemembers addressed by the IOM report are not presently eligible 
for the regulatory disease-based presumptions of service connection.
    This interim final rule establishes factual presumptions that will 
allow Air Force Reservists who are presumed under this interim final 
rule to have been exposed to herbicide during their reserve service to 
establish veteran status as a result of that service. Although section 
101(24) requires a period of active duty for training or inactive duty 
training ``during which the individual concerned was disabled or died'' 
for a period of active duty for training or inactive duty training to 
constitute ``active military, naval, or air service,'' the latent 
effects of herbicide exposure were unrecognized when section 101(24) 
was enacted in 1958. Operation Ranch Hand spraying commenced in 1962 
and concluded in 1971, and Congress recognized the need for 
presumptions of service connection for Agent Orange-related conditions 
and regular evaluation of the science related to such conditions in the 
Agent Orange Act of 1991, Public Law 102-4. Pursuant to this law, the 
IOM in 1992 entered into an agreement with VA to review and summarize 
scientific evidence concerning the association between herbicide 
exposure during Vietnam service and conditions that might be associated 
with such exposure. It issued its first report on the subject in 1994. 
See Institute of Medicine, National Academy of Sciences, Veterans and 
Agent Orange: Health Effects of Herbicides Used in Vietnam (1994), 
available at http://www.publichealth.va.gov/exposures/agentorange/publications/institute-of-medicine.asp. Thus, in enacting section 
101(24), Congress was necessarily unaware of later scientific 
understanding of the potential latent effects of herbicide exposure. 
Indeed, Congress was necessarily informed by the science that existed 
at the time of enactment in 1958.
    The legislative history regarding the enactment of section 101(24) 
does not specifically explain Congress' intent in requiring that the 
individual ``was disabled or died'' during the period of service. It is 
probable that Congress required a reserve component member to have been 
disabled ``during'' training because the medical science of the time 
understood that, if an in-service injury were to result in disability, 
at least some aspect of that disability generally would be manifest 
contemporaneous with the injury. However, subsequent developments with 
regard to herbicide use in Vietnam and advancements in medical 
understanding of the health effects of herbicide exposure raise a 
question regarding the application of section 101(24) to disability 
associated with such exposure. Viewing the generally beneficial purpose 
of section 101(24) in light of the evolved medical understanding, we 
believe it is reasonable to create a factual presumption that 
disability occurred during the period of service as required under 
section 101(24) when an individual has a present disability now 
scientifically associated with exposure to an herbicide agent. 
Specifically, the existing herbicide-related disease presumptions 
enumerated in 38 CFR 3.309(e), coupled with the potential for clinical 
uncertainty regarding when such diseases first manifested, provide a 
reasonable basis for presuming that disability occurred during a period 
of reserve service for purposes of satisfying the requirements under 
section 101(24)(B) or (C) in order to ensure compensation and health 
care for reservists disabled as a result of herbicide exposure on 
reserve duty.
    For the above reasons, we are amending 38 CFR 3.307 regarding 
disease associated with exposure to certain herbicide agents to add new 
paragraph (a)(6)(v). As amended, Sec.  3.307 will presume exposure to 
herbicide for ``[a]n individual who performed service in the Air Force 
or Air Force Reserve under circumstances in which the individual 
concerned regularly and repeatedly operated, maintained, or served 
onboard C-123 aircraft known to have been used to spray an herbicide 
agent during the Vietnam era.'' Further, in consideration of the 
reserve component members with such service, VA will consider this 
presumed herbicide exposure to be an ``injury'' under section 
101(24)(B) and (C). In turn, if such individual develops a presumptive 
disease listed in 38 CFR 3.309(e), as specified in 38 CFR 
3.307(a)(6)(ii), ``it will be presumed that the individual concerned 
became disabled during that service for purposes of establishing that 
the individual has active military, naval, or air service.'' VA will 
make the factual presumption that the individual concerned was disabled 
during the qualifying service so that such individual's service will 
constitute ``active, military, naval, or air service.'' As explained, 
we believe this is consistent with section 101(24) because herbicide 
exposure has uniquely latent effects which were largely unrecognized in 
1958. Covered individuals may therefore establish veteran status for 
purposes of VA's disability compensation, dependency and indemnity 
compensation, medical care, and burial benefits related to any Agent 
Orange-related presumptive condition.

Administrative Procedure Act

    The Secretary of Veterans Affairs finds under 5 U.S.C. 553(b)(B) 
that there is good cause that advance notice and opportunity for public 
comment are impracticable, unnecessary, or contrary to the public 
interest and under 5 U.S.C. 553(d)(3) that there is good cause to 
publish this rule with an immediate effective date. This interim final 
rule provides a presumption of herbicide exposure for individuals who 
performed certain military service. This interim final rule also 
establishes a presumption that if such an individual develops a 
presumptive herbicide-related condition, the individual concerned 
became disabled during that service for purposes of establishing that 
the individual has active military, naval, or air service. These 
changes will make individuals who were exposed to herbicide during 
service eligible for some VA benefits for disabilities resulting from 
herbicide-related diseases. Based on the age of the individuals 
affected by this rule and the potential severity of the disabilities 
associated with their herbicide exposure, it is likely that affected 
individuals will have significant and urgent financial and medical 
needs. In order for these individuals to have

[[Page 35248]]

access to VA benefits to include VA health care, it is essential that 
these rules be made effective as soon as possible.
    For the above reasons, the Secretary issues this rule as an interim 
final rule. However, VA will consider and address comments that are 
received within 60 days of the date this interim final rule is 
published in the Federal Register.

Paperwork Reduction Act

    This rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required in connection 
with the adoption of this interim final rule, no regulatory flexibility 
analysis is required under the Regulatory Flexibility Act, 5 U.S.C. 
601-612. Even so, the Secretary of Veterans Affairs certifies that this 
interim final rule will not directly affect any small entities. It will 
directly affect only VA beneficiaries. Accordingly, this interim 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.

Executive Order 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,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, 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 regulatory action have been examined, and it has 
been determined that it is not an economically significant regulatory 
action under Executive Order 12866. VA's regulatory impact analysis can 
be found as a supporting document at http://www.regulations.gov, 
usually within 48 hours after the rulemaking document is published. 
Additionally, a copy of the rulemaking and its regulatory impact 
analysis are available on VA's Web site at http://www.va.gov/orpm/, by 
following the link for ``VA Regulations Published From FY 2004 Through 
Fiscal Year to Date.''

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 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 one year. This interim final rule will have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.100, Automobiles and 
Adaptive Equipment for Certain Disabled Veterans and Members of the 
Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, 
Compensation for Service-Connected Deaths for Veterans' Dependents; 
64.104, Pension for Non-Service-Connected Disability for Veterans; 
64.105, Pension to Veterans Surviving Spouses and Children; 64.106, 
Specially Adapted Housing for Disabled Veterans; 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. Robert L. 
Nabors II, Chief of Staff, Department of Veterans Affairs, approved 
this document on May 11, 2015, 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: June 15, 2015.
William F. Russo,
Acting Director, Office of Regulation Policy & Management, Office of 
the General Counsel, Department of Veterans Affairs.

    For the reasons stated in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 3 to read as follows:

PART 3--ADJUDICATION

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

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.


0
2. Amend Sec.  3.307 by adding paragraph (a)(6)(v) immediately after 
paragraph (a)(6)(iv) and revising the authority citation at the end of 
the section to read as follows:


Sec.  3.307  Presumptive service connection for chronic, tropical or 
prisoner-of-war related disease, or disease associated with exposure to 
certain herbicide agents; wartime and service on or after January 1, 
1947.

    (a) * * *
    (6) * * *
    (v) An individual who performed service in the Air Force or Air 
Force Reserve under circumstances in which the individual concerned 
regularly and repeatedly operated, maintained, or served onboard C-123 
aircraft known to have been used to spray an herbicide agent during the 
Vietnam era shall be presumed to have been exposed during such service 
to an herbicide agent. For purposes of this paragraph, ``regularly and 
repeatedly operated, maintained, or served onboard C-123 aircraft'' 
means that the individual was assigned to an Air Force or Air Force 
Reserve squadron when the squadron was permanently assigned one of the 
affected aircraft and the individual had an Air Force Specialty Code 
indicating duties as a flight, ground maintenance, or medical crew 
member on such aircraft. Such exposure constitutes an injury under 38

[[Page 35249]]

U.S.C. 101(24)(B) and (C). If an individual described in this paragraph 
develops a disease listed in 38 CFR 3.309(e) as specified in paragraph 
(a)(6)(ii) of this section, it will be presumed that the individual 
concerned became disabled during that service for purposes of 
establishing that the individual served in the active military, naval, 
or air service.
* * * * *

(Authority: 38 U.S.C. 101(24), 501(a), 1116(a)(3), and 1821)


[FR Doc. 2015-14995 Filed 6-18-15; 8:45 am]
 BILLING CODE 8320-01-P