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 https:// 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 https:// 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 https://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 https://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 https://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 https://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 https://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: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// 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, https://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

DEPARTMENT OF VETERANS AFFAIRS

[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.

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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 https://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 https://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 https://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 https://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

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