Ҥ 1171. Procedures to determine presumptions of service connection based on toxic exposure; definitions

“(a) Procedures.—The Secretary shall determine whether to establish, or to remove, presumptions of service connection based on toxic exposure pursuant to this subchapter, whereby—

“(1) the Formal Advisory Committee on Toxic Exposure under section 1172 assesses research regarding veterans who, during active military, naval, or air service, were exposed to toxic substances, commissions additional research, and provides nominations for the Science Review Board to evaluate the research;

“(2) the Science Review Board under section 1173 evaluates research nominated by the Formal Advisory Committee on Toxic Exposure and determines the strength of evidence supporting a positive association between exposure to a toxic substance and an illness;

“(3) the Working Group under section 1174 evaluates the conclusions of the Science Review Board and recommends to the Secretary whether to establish or modify a presumption of service connection; and

“(4) the Secretary prescribes regulations under section 1175.

“(b) Illness defined.—In this subchapter, the term ‘illness’ includes a disease or other condition affecting the health of an individual.

“(c) Nonapplication of sunset requirements.—Section 14 of the Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to an entity established under this subchapter.

Ҥ 1172. Formal Advisory Committee on Toxic Exposure

“(a) Establishment.— (1) There is in the Veterans Benefits Administration of the Department the Formal Advisory Committee on Toxic Exposure (in this section referred to as the ‘Committee’).

“(2) The Secretary shall appoint not more than 10 members to the Committee, of which—

“(A) at least one member shall be appointed from among individuals who are officials or employees of the Veterans Benefits Administration or the Veterans Health Administration;

“(B) at least one member shall be appointed from among individuals who are officials or employees of other departments or agencies of the Federal Government, including the Department of Defense and the Agency of Toxic Substances and Disease Registry of the Centers for Disease Control and Prevention;

“(C) at least three members shall be appointed from among individuals who are representatives of disabled veterans; and

“(D) at least one member shall be appointed from among individuals in the private sector, State or local government, or academia, who are experts in toxicology and epidemiology.

“(3) The Secretary shall determine the pay and allowances of the members, including with respect to any additional pay and allowances for members who are officials or employees of the Federal Government.

“(4) Each member of the Committee shall be appointed for a two-year term, and may serve not more than three successive terms.

“(5) A vacancy in the Committee shall be filled in the manner in which the original appointment was made.

“(b) Consultation.—The Secretary may consult with, and seek the advice of, the Committee with respect to disability-related questions relating to veterans who, during active military, naval, or air service, are suspected of having been exposed to toxic substances.

“(c) Assessments.— (1) The Committee shall assess the exposure of veterans to toxic substances that occurred during active military, naval, or air service.

“(2) The assessments under paragraph (1) shall cover suspected and known toxic exposures occurring during active military, naval, or air service, including by identifying and evaluating new and emerging exposures that are not recognized under existing presumptions of service connection.

“(3) The Committee may conduct an assessment under paragraph (1) in response to a recommendation by the Science Review Board pursuant to section 1173(c)(2)(B) of this title or the Working Group under section 1174(c)(1)(B).

“(4) In assessing the exposure of veterans to toxic substances under paragraph (1), the Commission shall determine whether—

“(A) under subsection (d), further research into the exposure is warranted;

“(B) under subsection (e), the existing research being assessed is sufficient to nominate to the Science Review Board under section 1173 of this title for evaluation;

“(C) under subsection (f), there is sufficient evidence regarding an existing presumption of service connection for review by the Science Review Board or Working Group under section 1174 of this title, as the case may be; or

“(D) no further action is warranted.

“(d) Research.— (1) (A) Following an assessment of the exposure of veterans to toxic substances that occurred during active military, naval, or air service under subsection (c), the Committee may commission an appropriate entity (including an element of the Department, an academic entity, or a private-sector entity) to conduct additional research into the exposure and the health effects of the exposure, including such research to be conducted in response to data and analyses provided by the Secretary of Defense or the Secretary of Veterans Affairs relating to suspected toxic exposure occurring during such service.

“(B) In carrying out subparagraph (A), the Committee shall determine whether additional research is needed with respect to the following:

“(i) Identification of the composition of suspected toxic substances.

“(ii) Exposure assessments.

“(iii) Epidemiological studies.

“(iv) Toxicology and mechanistic studies.

“(C) In carrying out subparagraph (A), the Committee shall consider the following information:

“(i) All available health tracking data.

“(ii) All available surveillance data.

“(iii) All germane research previously considered by the Committee.

“(2) In assessing the suitability of topics for additional research pursuant to subparagraph (A), the Committee shall consider the following:

“(A) Conditions of service in the active military, naval, or air service, known or suspected exposure to agents, and circumstances of exposure.

“(B) Existing evidence of a connection between illnesses and service in the active military, naval, or air service, and the size or ability to define the group of affected veterans.

“(C) In accordance with subsection (g), input from persons who may be affected by the actions of the Committee.

“(D) Exposure assessments, including data on activities of the Armed Forces or exposures that may be classified.

“(E) Existing health tracking and surveillance, including veterans and members of the active military, naval, or air service, such as the burn pit registry established under section 201 of the Dignified Burial and Other Veterans' Benefits Improvement Act of 2012 (Public Law 112–260; 38 U.S.C. 527 note).

“(F) Research, including laboratory research discoveries and findings from studies of members of the active military, naval, or air service and civilian workers who were exposed to toxic substances.

“(G) The effect of sex, gender, age, race, and ethnicity on health outcomes.

“(3) The Committee shall ensure that the research commissioned under paragraph (1) is tailored to produce results or conclusions necessary for the Science Review Board to make a fully informed assessment.

“(e) Nomination.—If the Committee determines further action is appropriate with respect to an assessment of the exposure of veterans to toxic substances that occurred during active military, naval, or air service under subsection (c), the Committee may nominate the Science Review Board to evaluate either or both, as the case may be—

“(1) the existing research included in the assessment; or

“(2) the further research conducted pursuant to subsection (d).

“(f) Review of existing presumptions.— (1) Upon receipt of evidence suggesting that previous findings supporting a positive association between an exposure and an illness are no longer valid, the Committee may nominate such exposure or illness for review by the Science Review Board.

“(2) Upon receipt of evidence suggesting that previous findings regarding the periods and locations of exposure covered by an existing presumption of service connection are no longer supported, the Committee may nominate such evidence for evaluation by the Working Group to modify the periods and locations.

“(g) Input.— (1) Not less than quarterly, the Committee shall provide an opportunity for persons described in paragraph (2) to present written or oral comments to the Committee.

“(2) The persons described in this paragraph are persons who may be affected by the actions of the Committee, including—

“(A) veterans, the families of veterans, veterans service organizations and representatives, researchers, and other members of the general public; and

“(B) departments and agencies of the Federal Government.

“(h) Reports to Congress.—On a biennial basis, the Committee shall submit to the Committees on Veterans’ Affairs of the House of Representatives and the Senate, and make publicly available, a report on the actions of the Committee. Each such report shall include, with respect to the period covered by the report, the following:

“(1) A description of—

“(A) the exposure and evidence considered by the Committee;

“(B) any research commissioned by the Committee; and

“(C) the rationale of the nominations made by the Committee to the Science Review Board for further evaluation.

“(2) A description of each specific action recommended by the Committee described in subsection (c)(3).

“(3) Each report received by the Committee under section 1173(c)(2) of this title.

Ҥ 1173. Science Review Board

“(a) Establishment.— (1) There is in the Department the Science Review Board (in this section referred to as the ‘Board’).

“(2) (A) The members of the Board shall be appointed by the Secretary from the general public from among individuals who are distinguished in the fields of medicine, biological sciences, or health administration.

“(B) An individual may not concurrently serve on the Board and the Formal Advisory Committee on Toxic Exposure under section 1172 of this title.

“(C) The Secretary shall determine the number, terms of service, and pay and allowances of members of the Board appointed by the Secretary.

“(b) Duties.— (1) Upon receiving a nomination for the evaluation of research on the health effects of exposure of members of the active military, naval, or air service to toxic substances made by the Formal Advisory Committee on Toxic Exposure pursuant to section 1172 of this title, the Board shall—

“(A) evaluate the likelihood that an illness is associated with an exposure to a toxic substance while serving in the active military, naval, or air service; and

“(B) assess the exposures and illnesses identified by the Committee and determine whether the evidence supports a finding of a positive association between the exposure and the illness.

“(2) In carrying out paragraph (1)(B), the Board shall review all relevant data to determine, with respect to the strength of evidence for a positive association, that there is—

“(A) sufficient evidence of an association;

“(B) limited or suggestive evidence of an association;

“(C) inadequate or insufficient evidence to determine an association; or

“(D) limited or suggestive evidence of no association.

“(3) With respect to an evaluation conducted under this subsection, if the Board determines that the evidence for a positive association is inadequate or insufficient to determine an association as described in paragraph (2)(C), the Board shall develop a recommendation as to whether additional data gathering and research are necessary.

“(c) Reports.— (1) For each evaluation conducted under subsection (b) where the Board determines that the evidence for a positive association is either sufficient or limited or suggestive of an association, as described in subparagraph (A) or (B) of paragraph (2) of such subsection, the Board shall submit to the Secretary, the Working Group under section 1174 of this title, and to the Committees on Veterans’ Affairs of the House of Representatives and the Senate a report identifying the evidence found to reach such positive association determinations.

“(2) For each evaluation conducted under subsection (b) where the Board determines that the evidence for positive association is inadequate or insufficient to determine an association as described in paragraph (2)(C) of such subsection, the Board shall submit to the Secretary, the Formal Advisory Committee on Toxic Exposure, and to the Committees on Veterans’ Affairs of the House of Representatives and the Senate a report—

“(A) identifying the evidence found to reach such positive association determinations; and

“(B) containing the recommendations under subsection (b)(3) as to whether additional data gathering and research are necessary and an outline of a report request proposal for such additional data and research.

Ҥ 1174. Working group on presumptions of service connection

“(a) Establishment.—The Secretary shall establish a working group (in this section referred to as the ‘Working Group’) to—

“(1) evaluate—

“(A) the conclusions of the Science Review Board contained in each report submitted under section 1173(c)(1) of this title; and

“(B) evidence nominated by the Formal Advisory Committee on Toxic Exposure under section 1172(f)(2) regarding the periods and locations of exposure covered by an existing presumption of service connection; and

“(2) make a recommendation to the Secretary with respect to whether to—

“(A) establish a presumption of service connection for the toxic exposure and illness covered by the report described in subparagraph (A) of paragraph (1); or

“(B) modify an existing presumption of service connection described in subparagraph (B) of such paragraph.

“(b) Evaluations.— (1) In evaluating the conclusions of the Science Review Board, the Working Group shall consider factors, in addition to the conclusions of the Board, that the Working Group determines appropriate.

“(2) The Working Group shall provide a period of not fewer than 60 days for persons described in section 1172(g)(2) of this title to present written comments to the Working Group with respect to each evaluation made under this section.

“(c) Recommendations.— (1) In making a recommendation under subsection (a)(2), the Working Group shall—

“(A) in cases where the evidence for a positive association is either sufficient or limited or suggestive of an association, as described in subparagraph (A) or (B) of section 1173(b)(2) of this title, weigh heavily in favor of establishing a presumption of service connection; and

“(B) if the Working Group determines that additional research, studies, or reports are appropriate before making a final recommendation with respect to establishing or modifying a presumption of service connection, submit to the Formal Advisory Committee a description of such appropriate additional research, studies, or reports.

“(2) Not later than 60 days after the date on which the comment period under subsection (b)(2) ends with respect to an evaluation made under this section, the Working Group shall submit to the Secretary and to the Committees on Veterans’ Affairs of the House of Representatives and the Senate a description of the recommendation made under subsection (a)(2).

Ҥ 1175. Regulations regarding presumptions of service connection based on toxic exposure

“(a) Action upon Working Group recommendation.—Not later than 60 days after the date on which the Secretary receives a recommendation to establish or modify a presumption of service connection under section 1174(c)(2) of this title—

“(1) if the Secretary determines that the presumption, or modification, is warranted, the Secretary shall issue proposed regulations setting forth the presumption or revise regulations to carry out such modification; or

“(2) if the Secretary determines that the presumption, or modification, is not warranted, the Secretary shall publish in the Federal Register a notice of the determination, including the reasons supporting the determination.

“(b) Final regulation.—Not later than 90 days after the date on which the Secretary issues any proposed regulations under subsection (a)(1), the Secretary shall issue final regulations. Such regulations shall be effective on the date of issuance.

“(c) Removal of presumption.— (1) The Secretary may issue regulations to remove an illness from a presumption of service connection previously established pursuant to a regulation issued under subsection (b).

“(2) Whenever an illness is removed from regulations pursuant to paragraph (1), or the periods and locations of exposure covered by a presumption of service connection are modified under subsection (a)—

“(A) a veteran who was awarded compensation for such illness on the basis of the presumption provided under such regulations before the effective date of the removal or modification shall continue to be entitled to receive compensation on that basis; and

“(B) a survivor of a veteran who was awarded dependency and indemnity compensation for the death of a veteran resulting from such illness on the basis of such presumption shall continue to be entitled to receive dependency and indemnity compensation on such basis.

Ҥ 1176. Expert Advisory Panel on Constrictive Bronchiolitis

“(a) Establishment.—There is in the Department the Expert Advisory Panel on Constrictive Bronchiolitis (in this section referred to as the ‘Panel’).

“(b) Membership.— (1) The Panel shall be appointed by the Secretary from the general public from among individuals who are—

“(A) experts in pulmonary pathology;

“(B) experts in other fields the Secretary determines appropriate, such as pulmonary medicine, toxicology, epidemiology, exposure assessment, and radiology; and

“(C) individuals representing the veterans community.

“(2) The Secretary shall determine the number, terms of service, and pay and allowances of members of the Panel appointed by the Secretary.

“(c) Duties.—The panel shall develop specific guidelines for research conducted by the Department of symptomatic veterans who served in the active military, naval, or air service in the Southwest Asia theater of operations whom the differential diagnosis includes bronchiolitis. The Panel shall—

“(1) determine the adequacy of lung biopsy approaches and recommend to the Secretary best practices;

“(2) make recommendations to the Secretary for processing, handling, and storing lung biopsies;

“(3) establish histologic and pathology criteria for confirming diagnoses; and

“(4) submit to the Secretary and to the Committees on Veterans’ Affairs of the House of Representatives and the Senate reports on the findings and results of such research.”.