Collapse to view only § 1172. Annual notice and opportunity for public comment

§ 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) under section 1172 of this title
(A) the Secretary provides—
(i) public notice regarding what formal evaluations the Secretary plans to conduct; and
(ii) the public an opportunity to comment on the proposed formal evaluations;
(B) the working group established under subsection (b) of such section provides—
(i) advice to the Secretary on toxic-exposed veterans and cases in which veterans who, during active military, naval, air, or space service, may have experienced a toxic exposure or their dependents may have experienced a toxic exposure while the veterans were serving in the active military, naval, air, or space service;
(ii) recommendations to the Secretary on corrections needed in the Individual Longitudinal Exposure Record to better reflect veterans and dependents described in clause (i); and
(iii) recommendations to the Secretary regarding which cases of possible toxic exposure should be reviewed;
(2) the Secretary provides for formal evaluations of such recommendations under section 1173 of this title and takes into account reports received by the Secretary from the National Academies of Sciences, Engineering, and Medicine under section 1176 of this title; and
(3) the Secretary issues regulations under section 1174 of this title.
(b)Definitions.—In this subchapter:
(1) The term “illness” includes a disease or other condition affecting the health of an individual, including mental and physical health.
(2) The term “Individual Longitudinal Exposure Record” includes—
(A) service records;
(B) any database maintained by the Department of Defense and shared with the Department of Veterans Affairs to serve as a central portal for exposure-related data that compiles, collates, presents, and provides available occupational and environmental exposure information to support the needs of the Department of Defense and the Department of Veterans Affairs; or
(C) any successor system to a database described in subparagraph (B).
(Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1767.)
§ 1172. Annual notice and opportunity for public comment
(a)Notice Required.—
(1)
(A) Not less frequently than once each year, the Secretary shall publish in the Federal Register notice of the formal evaluations that the Secretary plans to conduct pursuant to section 1173 of this title.
(B) Each notice published under subparagraph (A) shall include, for each formal evaluation referred to in the notice, an explanation as to why the military environmental exposures and adverse health outcomes that are the subject of the formal evaluation were chosen by the Secretary for formal evaluation under section 1173 of this title.
(2)
(A) With each notice published under paragraph (1), the Secretary shall seek public comment on the military environmental exposures and adverse health outcomes that are the subject of the formal evaluations referred to in the notice.
(B) The Secretary shall—
(i) consider all public comment received under subparagraph (A); and
(ii) publish in the Federal Register a response to the comments received under subparagraph (A).
(3)
(A) For each notice published under paragraph (1), the Secretary shall hold an open meeting for members of the public to voice their comments in response to the notice.
(B) To help evaluate presumptions of service connection, the Secretary shall, not less frequently than quarterly, collaborate with, partner with, and give weight to the advice of veterans service organizations and such other stakeholders as the Secretary considers appropriate.
(4) Failure to include a military environmental exposure or adverse health effect in a Federal Register notice published pursuant to subsection (a) shall not preclude the Secretary from initiating a formal evaluation of such exposure or health effect.
(b)Working Group.—
(1) The Secretary shall establish a working group within the Department (in this section referred to as the “Working Group”).
(2) The Working Group shall include personnel of the Veterans Health Administration and the Veterans Benefits Administration.
(3) The Secretary shall consult with, and seek the advice of, the Working Group with respect to cases in which—
(A) a veteran may have, during active military, naval, air, or space service, experienced a toxic exposure; or
(B) a dependent of a veteran may have experienced a toxic exposure during the active military, naval, air, or space service of the veteran.
(c)Assessments.—
(1) The Working Group shall assess cases of the toxic exposure of veterans and their dependents that occurred during active military, naval, air, or space service, including by conducting ongoing surveillance and reviewing such exposure described in scientific literature, media reports, information from veterans, and information from Congress.
(2) The assessments under paragraph (1) shall cover suspected and known toxic exposures occurring during active military, naval, air, or space service, including by identifying and evaluating new and emerging toxic exposures that are not recognized under existing presumptions of service connection.
(3) The Working Group may conduct an assessment under paragraph (1) in response to a comment received under paragraph (2) or (3) of subsection (a).
(4) The Working Group shall, in consultation with the Secretary of Defense, on a periodic basis, assess the Individual Longitudinal Exposure Record to ensure the accuracy of data collected.
(d)Development of Recommendations.—
(1) Following an assessment of a case of the toxic exposure of veterans that occurred during active military, naval, air, or space service under subsection (c), or their dependents, the Working Group may develop a recommendation for formal evaluation under section 1173 of this title to conduct a review of the health effects related to the case of exposure if the Working Group determines that the research may change the current understanding of the relationship between an exposure to an environmental hazard and adverse health outcomes in humans.
(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 Working Group may nominate such evidence for formal evaluation under section 1173 of this title to modify the periods and locations.
(e)Reports by the Working Group.—Not less frequently than once each year, the Working Group shall submit to the Secretary, the Committee on Veterans’ Affairs of the Senate, and the Committee on Veterans’ Affairs of the House of Representatives, and make publicly available, a report on—
(1) recommendations developed under subsection (d), if any; and
(2) recommendations for such legislative or administrative action as the Working Group considers necessary for the Working Group to be more effective in carrying out the requirements of this section.
(f)Responses by Secretary.—In response to each report submitted under subsection (e), the Secretary shall, not later than 30 days after receiving the report, initiate a formal evaluation pursuant to section 1173 of this title.
(Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1768.)
§ 1173. Formal evaluation of recommendations
(a)Formal Evaluations.—The Secretary shall establish a process to conduct a formal evaluation with respect to each recommendation made by the Working Group under section 1172 of this title.
(b)Evidence, Data, and Factors.—The Secretary shall ensure that each formal evaluation under subsection (a) covers the following:
(1) Scientific evidence, based on the review of available scientific literature, including human, toxicological, animal, and methodological studies, and other factors.
(2) Claims data, based on the review of claim rate, grant rate, and service connection prevalence, and other factors.
(3) Other factors the Secretary determines appropriate, such as—
(A) the level of disability and mortality caused by the health effects related to the case of toxic exposure being evaluated;
(B) the quantity and quality of the information available and reviewed;
(C) the feasibility of and period for generating relevant information and evidence;
(D) whether such health effects are combat- or deployment-related;
(E) the ubiquity or rarity of the health effects; and
(F) any time frame during which a health effect must become manifest.
(c)Conduct of Evaluations.—
(1) The Secretary shall ensure that each formal evaluation under subsection (a)—
(A) reviews scientific evidence in a manner that—
(i) conforms to principles of scientific and data integrity;
(ii) is free from suppression or distortion of scientific or technological findings, data, information, conclusions, or technical results; and
(B)
(i) evaluates the likelihood that a positive association exists between an illness and a toxic exposure while serving in the active military, naval, air, or space service; and
(ii) assesses the toxic exposures and illnesses and determines whether the evidence supports a finding of a positive association between the toxic exposure and the illness.
(2) In carrying out paragraph (1)(B)(ii), a formal evaluation under subsection (a) shall include reviewing all relevant data to determine the strength of evidence for a positive association based on the following four categories:
(A) The “sufficient” category, where the evidence is sufficient to conclude that a positive association exists.
(B) The “equipoise and above” category, where the evidence is sufficient to conclude that a positive association is at least as likely as not, but not sufficient to conclude that a positive association exists.
(C) The “below equipoise” category, where the evidence is not sufficient to conclude that a positive association is at least as likely as not, or is not sufficient to make a scientifically informed judgment.
(D) The “against” category, where the evidence suggests the lack of a positive association.
(d)Recommendation for Establishing a Presumption of Service Connection.—Not later than 120 days after the date on which a formal evaluation is commenced, the element of the Department that conducts the evaluation shall submit to the Secretary a recommendation with respect to establishing a presumption of service connection for the toxic exposure and illness, or modifying an existing presumption of service connection, covered by the evaluation.
(Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1769.)
§ 1174. Regulations regarding presumptions of service connection based on toxic exposure
(a)Action Upon Recommendation.—Not later than 160 days after the date on which the Secretary receives a recommendation to establish or modify a presumption of service connection under section 1173 of this title
(1) if the Secretary determines, in the discretion of the Secretary, that the presumption, or modification, is warranted, the Secretary shall—
(A) commence issuing regulations in accordance with the provisions of subchapter II of chapter 5 of title 5 (commonly referred to as the Administrative Procedures Act) setting forth the presumption or commence revising regulations to carry out such modification; and
(B) include in such regulations any time frame during which a health effect must become manifest; or
(2) if the Secretary determines, in the discretion of the Secretary, 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)Removal of Presumption.—
(1)
(A) The Secretary may—
(i) issue a regulation to remove an illness from a presumption of service connection previously established pursuant to a regulation issued under subsection (a); and
(ii) issue a regulation to remove a presumption of service connection established pursuant to title IV of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 if the Secretary concludes that evidence suggests the lack of a positive association between the disease and the toxic exposure.
(B) Under subparagraph (A)(ii), the Secretary shall not consider the lack of evidence as sufficient to support a decision for removal of a presumption.
(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 under chapter 11 of this title 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;
(B) a survivor of a veteran who was awarded dependency and indemnity compensation under chapter 13 of this title 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; and
(C) no veteran or survivor covered under subparagraph (A) or (B) shall have their compensation reduced solely because of the removal of an illness pursuant to paragraph (1).
(Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1770.)
§ 1175. Authority to modify process; congressional oversight
(a)In General.—The Secretary may modify the process under which the working group established under subsection (b) of section 1172 of this title conducts assessments under such section, the Secretary conducts formal evaluations under section 1173 of this title, and issues regulations under section 1174 of this title if—
(1) such evaluations cover the evidence, data, and factors required by subsection (b) of such section 1173; and
(2) a period of 180 days has elapsed following the date on which the Secretary submits the notice under subsection (b) regarding the modification.
(b)Notice.—If the Secretary proposes to modify the process under which the working group established under subsection (b) of section 1172 of this title conducts assessments under such section, the process under which the Secretary conducts formal evaluations under section 1173 of this title, or issues regulations under section 1174 of this title, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a notice of the proposed modifications containing the following:
(1) A description of the proposed modifications.
(2) A description of any exceptions to the requirements of such sections that are proposed because of limited available scientific evidence, and a description of how such evaluations will be conducted.
(Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1771.)
§ 1176. Agreement with National Academies of Sciences, Engineering, and Medicine concerning toxic exposures
(a)Purpose.—The purpose of this section is to provide for the National Academies of Sciences, Engineering, and Medicine (in this section referred to as the “Academies”), an independent nonprofit scientific organization with appropriate expertise that is not part of the Federal Government, to review and evaluate the available scientific evidence regarding associations between diseases and toxic exposures.
(b)Agreement.—
(1) The Secretary shall seek to enter into a five-year agreement with the Academies to perform the services covered by this section.
(2) The Secretary shall seek to enter into an agreement described in paragraph (1) not later than 60 days after the date of the enactment of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022.
(3) An agreement under this section may be extended in five-year increments.
(c)Review of Scientific Evidence.—Under an agreement between the Secretary and the Academies under this section, the Academies shall review and summarize the scientific evidence, and assess the strength thereof, concerning the association between toxic exposures during active military, naval, air, or space service and each disease suspected to be associated with such exposure in the human population.
(d)Scientific Determinations Concerning Diseases.—For each disease reviewed under subsection (c), the Academies shall determine, to the extent that available scientific data permit meaningful determinations—
(1) whether an association exists between toxic exposures and the occurrence of the disease, taking into account the strength of the scientific evidence and the appropriateness of the statistical and epidemiological methods used to detect the association;
(2) the increased risk of the disease among those reporting toxic exposures during active military, naval, air, or space service;
(3) whether there exists a plausible biological mechanism or other evidence of a positive association between the toxic exposure and the occurrence of the disease; and
(4) determine the strength of evidence for a positive association based on categories furnished under section 1173 of this title.
(e)Cooperation of Federal Agencies.—The head of each relevant Federal agency, including the Secretary of Defense, shall cooperate fully with the Academies in performing the services covered by this section.
(f)Recommendations for Additional Scientific Studies.—
(1) Under an agreement between the Secretary and the Academies under this section, the Academies shall make any recommendations for additional scientific studies to resolve areas of continuing scientific uncertainty relating to toxic exposures.
(2) In making recommendations under paragraph (1), the Academies shall consider—
(A) the scientific information that is available at the time of the recommendation;
(B) the value and relevance of the information that could result from additional studies; and
(C) the cost and feasibility of carrying out such additional studies.
(g)Reports.—
(1)
(A) Under an agreement between the Secretary and the Academies under this section, not later than one year after the date of the enactment of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022, the Academies shall submit to the Secretary, the Committee on Veterans’ Affairs of the Senate, and the Committee on Veterans’ Affairs of the House of Representatives an initial report on the activities of the Academies under the agreement.
(B) The report submitted under subparagraph (A) shall include the following:
(i) The determinations described in subsection (d).
(ii) A full explanation of the scientific evidence and reasoning that led to such determinations.
(iii) Any recommendations of the Academies under subsection (f).
(2) Under an agreement between the Secretary and the Academies under this section, not less frequently than once every two years after the date on which the initial report is submitted under paragraph (1)(A), the Academies shall submit to the Secretary, the Committee on Veterans’ Affairs of the Senate, and the Committee on Veterans’ Affairs of the House of Representatives an updated report on the activities of the Academies under the agreement.
(h)Alternative Contract Scientific Organization.—
(1) If the Secretary is unable within the time period prescribed in subsection (b)(2) to enter into an agreement with the Academies for the purposes of this section on terms acceptable to the Secretary, the Secretary shall seek to enter into an agreement for the purposes of this section with another appropriate scientific organization that—
(A) is not part of the Federal Government;
(B) operates as a not-for-profit entity; and
(C) has expertise and objectivity comparable to that of the Academies.
(2) If the Secretary enters into an agreement with another organization as described in paragraph (1), any reference in this subchapter to the Academies shall be treated as a reference to the other organization.
(Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1772.)