(a)(1) For the purposes of section 1110 of this title, and subject to section 1113 of this title-
(A) a disease specified in paragraph (2) of this subsection becoming manifest as specified in that paragraph in a veteran who, during active military, naval, or air service, served in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975; and
(B) each additional disease (if any) that (i) the Secretary determines in regulations prescribed under this section warrants a presumption of service-connection by reason of having positive association with exposure to an herbicide agent, and (ii) becomes manifest within the period (if any) prescribed in such regulations in a veteran who, during active military, naval, or air service, served in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975, and while so serving was exposed to that herbicide agent,
shall be considered to have been incurred in or aggravated by such service, notwithstanding that there is no record of evidence of such disease during the period of such service.
(2) The diseases referred to in paragraph (1)(A) of this subsection are the following:
(A) Non-Hodgkin's lymphoma becoming manifest to a degree of disability of 10 percent or more.
(B) Each soft-tissue sarcoma becoming manifest to a degree of disability of 10 percent or more other than osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or mesothelioma.
(C) Chloracne or another acneform disease consistent with chloracne becoming manifest to a degree of disability of 10 percent or more within one year after the last date on which the veteran performed active military, naval, or air service in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975.
(D) Hodgkin's disease becoming manifest to a degree of disability of 10 percent or more.
(E) Porphyria cutanea tarda becoming manifest to a degree of disability of 10 percent or more within a year after the last date on which the veteran performed active military, naval, or air service in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975.
(F) Respiratory cancers (cancer of the lung, bronchus, larynx, or trachea) becoming manifest to a degree of disability of 10 percent or more.
(G) Multiple myeloma becoming manifest to a degree of disability of 10 percent or more.
(H) Diabetes Mellitus (Type 2).
(3) For purposes of this section, the term "herbicide agent" means a chemical in an herbicide used in support of the United States and allied military operations in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975.
(b)(1) Whenever the Secretary determines, on the basis of sound medical and scientific evidence, that a positive association exists between (A) the exposure of humans to an herbicide agent, and (B) the occurrence of a disease in humans, the Secretary shall prescribe regulations providing that a presumption of service connection is warranted for that disease for the purposes of this section.
(2) In making determinations for the purpose of this subsection, the Secretary shall take into account (A) reports received by the Secretary from the National Academy of Sciences under section 3 of the Agent Orange Act of 1991, and (B) all other sound medical and scientific information and analyses available to the Secretary. In evaluating any study for the purpose of making such determinations, the Secretary shall take into consideration whether the results are statistically significant, are capable of replication, and withstand peer review.
(3) An association between the occurrence of a disease in humans and exposure to an herbicide agent shall be considered to be positive for the purposes of this section if the credible evidence for the association is equal to or outweighs the credible evidence against the association.
(c)(1)(A) Not later than 60 days after the date on which the Secretary receives a report from the National Academy of Sciences under section 3 of the Agent Orange Act of 1991, the Secretary shall determine whether a presumption of service connection is warranted for each disease covered by the report. If the Secretary determines that such a presumption is warranted, the Secretary, not later than 60 days after making the determination, shall issue proposed regulations setting forth the Secretary's determination.
(B) If the Secretary determines that a presumption of service connection is not warranted, the Secretary, not later than 60 days after making the determination, shall publish in the Federal Register a notice of that determination. The notice shall include an explanation of the scientific basis for that determination. If the disease already is included in regulations providing for a presumption of service connection, the Secretary, not later than 60 days after publication of the notice of a determination that the presumption is not warranted, shall issue proposed regulations removing the presumption for the disease.
(2) Not later than 90 days after the date on which the Secretary issues any proposed regulations under this subsection, the Secretary shall issue final regulations. Such regulations shall be effective on the date of issuance.
(d) Whenever a disease is removed from regulations prescribed under this section-
(1) a veteran who was awarded compensation for such disease on the basis of the presumption provided in subsection (a) before the effective date of the removal shall continue to be entitled to receive compensation on that basis; and
(2) a survivor of a veteran who was awarded dependency and indemnity compensation for the death of a veteran resulting from such disease on the basis of such presumption shall continue to be entitled to receive dependency and indemnity compensation on such basis.
(e) Subsections (b) through (d) shall cease to be effective on September 30, 2015.
(f) For purposes of establishing service connection for a disability or death resulting from exposure to a herbicide agent, including a presumption of service-connection under this section, a veteran who, during active military, naval, or air service, served in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975, shall be presumed to have been exposed during such service to an herbicide agent containing dioxin or 2,4-dichlorophenoxyacetic acid, and may be presumed to have been exposed during such service to any other chemical compound in an herbicide agent, unless there is affirmative evidence to establish that the veteran was not exposed to any such agent during that service.
(Added
Section 3 of the Agent Orange Act of 1991, referred to in subsecs. (b)(2) and (c)(1)(A), is section 3 of
2001-
Subsec. (a)(2)(F).
Subsec. (a)(2)(H).
Subsec. (a)(3), (4).
Subsec. (e).
Subsec. (f).
2000-Subsec. (a)(2)(F).
1996-Subsec. (a)(1)(A).
Subsec. (a)(1)(B).
Subsec. (a)(2)(C), (E), (F).
Subsec. (a)(3).
Subsec. (a)(4).
1994-Subsec. (a)(1)(B).
Subsec. (a)(2)(D) to (G).
1991-
Subsec. (a)(1).
Amendment by
"In this subtitle:
"(1)
"(2)
"(3)
"(4)
"(a)
"(1)
"(2)
"(A)
"(i) is not part of the Federal Government;
"(ii) operates as a not-for-profit entity; and
"(iii) has expertise and objectivity comparable to that of the National Academy of Medicine.
"(B)
"(b)
"(1) A scientific review of the scientific literature regarding toxicological and epidemiological research on descendants of individuals with toxic exposure.
"(2) An assessment of areas requiring further scientific study relating to the descendants of veterans with toxic exposure.
"(3) An assessment of the scope and methodology required to conduct adequate scientific research relating to the descendants of individuals with toxic exposure, including-
"(A) the types of individuals to be studied, including veterans with toxic exposure and the descendants of those veterans;
"(B) the number of veterans and descendants described in subparagraph (A) to be studied;
"(C) the potential alternatives for participation in such a study, including whether it would be necessary for participants to travel in order to participate;
"(D) the approximate amount of time and resources needed to prepare and conduct the research; and
"(E) the appropriate Federal agencies to participate in the research, including the Department of Defense and the Department of Veterans Affairs.
"(4) The establishment of categories, including definitions for each such category, to be used in assessing the evidence that a particular health condition is related to toxic exposure, such as-
"(A) sufficient evidence of a causal relationship;
"(B) sufficient evidence of an association;
"(C) limited or suggestive evidence of an association;
"(D) inadequate or insufficient evidence to determine whether an association exists; and
"(E) limited or suggestive evidence of no association.
"(5) An analysis of-
"(A) the feasibility of conducting scientific research to address the areas that require further study as described under paragraph (2);
"(B) the value and relevance of the information that could result from such scientific research; and
"(C) for purposes of conducting further research, the feasibility and advisability of accessing additional information held by a Federal agency that may be sensitive.
"(6) An identification of a research entity or entities with-
"(A) expertise in conducting research on health conditions of descendants of individuals with toxic exposure; and
"(B) an ability to conduct research on those health conditions to address areas requiring further scientific study as described under paragraph (2).
"(c)
"(1) the results of the assessment conducted pursuant to such agreement, including such recommendations as the National Academy of Medicine considers appropriate regarding the scope and methodology required to conduct adequate scientific research relating to the descendants of veterans with toxic exposure; and
"(2) a determination regarding whether the results of such assessment indicate that it is feasible to conduct further research regarding health conditions of descendants of veterans with toxic exposure, including an explanation of the basis for the determination.
"(d)
"(1)
"(2)
"(a)
"(b)
"(1)
"(A) shall select not more than 13 voting members of the Advisory Board, of whom-
"(i) not less than two shall be members of organizations exempt from taxation under section 501(c)(19) of the Internal Revenue Code of 1986 [26 U.S.C. 501(c)(19)];
"(ii) not less than two shall be descendants of veterans with toxic exposure while serving as members of the Armed Forces; and
"(iii) not less than seven shall be health professionals, scientists, or academics who are not employees of the Federal Government and have expertise in-
"(I) birth defects;
"(II) developmental disabilities;
"(III) epigenetics;
"(IV) public health;
"(V) the science of environmental exposure or environmental exposure assessment;
"(VI) the science of toxic substances; or
"(VII) medical and research ethics; and
"(B) may select not more than two nonvoting members who are employees of the Federal Government and who are otherwise described in subparagraph (A)(iii).
"(2)
"(3)
"(A)
"(B)
"(c)
"(1) advise the Secretary in the selection of a research entity or entities to conduct research under section 634 from among those identified under section 632(b)(6);
"(2) advise such entity or entities and assess the activities of such entity or entities in conducting such research;
"(3) develop a research strategy for such entity or entities based on, but not limited to, the results of the assessment conducted under section 632;
"(4) advise the Secretary with respect to the activities of such entity or entities under section 634;
"(5) submit recommendations to be included by such entity or entities in the report under section 634(d)(2)(C); and
"(6) not less frequently than semiannually, meet with the Secretary and representatives of such entity or entities on the research conducted by such entity or entities under section 634.
"(d)
"(e)
"(f)
"(g)
"(1)
"(2)
"(3)
"(a)
"(b)
"(1)
"(2)
"(3)
"(c)
"(1)
"(2)
"(d)
"(1)
"(2)
"(A) A summary of the research efforts that have been completed during the year preceding the submittal of the report and that are ongoing as of the date of the submittal of the report.
"(B) A description of any findings made during such year in carrying out such research efforts.
"(C) Recommendations for administrative or legislative action made by the Advisory Board based on such findings, which may include recommendations for further research under this section.
"(3)
"(2) The Secretary of Veterans Affairs shall enter into a contract with the National Academy of Sciences, not later than six months after the date of the enactment of this Act [Dec. 27, 2001], for the performance of a study to include a review of all available scientific literature on the effects of exposure to an herbicide agent containing dioxin on the development of respiratory cancers in humans and whether it is possible to identify a period of time after exposure to herbicides after which a presumption of service-connection for such exposure would not be warranted. Under the contract, the National Academy of Sciences shall submit a report to the Secretary setting forth its conclusions. The report shall be submitted not later than 18 months after the contract is entered into.
"(3) For a period of six months beginning on the date of the receipt of the report of the National Academy of Sciences under paragraph (2), the Secretary may, if warranted by clear scientific evidence presented in the National Academy of Sciences report, initiate a rulemaking under which the Secretary would specify a limit on the number of years after a claimant's departure from Vietnam after which respiratory cancers would not be presumed to have been associated with the claimant's exposure to herbicides while serving in Vietnam. Any such limit under such a rule may not take effect until 120 days have passed after the publication of a final rule to impose such a limit.
"(4)(A) Subject to subparagraphs (B) and (C), if the Secretary imposes such a limit under paragraph (3), that limit shall be effective only as to claims filed on or after the effective date of that limit.
"(B) In the case of any veteran whose disability or death due to respiratory cancer is found by the Secretary to be service-connected under section 1116(a)(2)(F) of title 38, United States Code, as amended by paragraph (1), such disability or death shall remain service-connected for purposes of all provisions of law under such title notwithstanding the imposition, if any, of a time limit by the Secretary by rulemaking authorized under paragraph (3).
"(C) Subaragraph [sic] (B) does not apply in a case in which-
"(i) the original award of compensation or service connection was based on fraud; or
"(ii) it is clearly shown from military records that the person concerned did not have the requisite service or character of discharge."
"(a)
"(b)
"(c)
"(d)
"(A) whether a statistical association with herbicide exposure exists, taking into account the strength of the scientific evidence and the appropriateness of the statistical and epidemiological methods used to detect the association;
"(B) the increased risk of the disease among those exposed to herbicides during service in the Republic of Vietnam during the Vietnam era; and
"(C) whether there exists a plausible biological mechanism or other evidence of a causal relationship between herbicide exposure and the disease.
"(2) The Academy shall include in its reports under subsection (g) a full discussion of the scientific evidence and reasoning that led to its conclusions under this subsection.
"(e)
"(f)
"(1) to conduct as comprehensive a review as is practicable of the evidence referred to in subsection (c) that became available since the last review of such evidence under this section; and
"(2) to make its determinations and estimates on the basis of the results of such review and all other reviews conducted for the purposes of this section.
"(g)
"(2) The first report under this subsection shall be transmitted not later than the end of the 18-month period beginning on the date of the enactment of this Act [Feb. 6, 1991]. That report shall include (A) the determinations and discussion referred to in subsection (d), (B) any recommendations of the Academy under subsection (e), and (C) the recommendation of the Academy as to whether the provisions of each of sections 6 through 9 [set out below] should be implemented by the Secretary. In making its recommendation with respect to each such section, the Academy shall consider the scientific information that is currently available, the value and relevance of the information that could result from implementing that section, and the cost and feasibility of implementing that section. If the Academy recommends that the provisions of section 6 should be implemented, the Academy shall also recommend the means by which clinical data referred to in that section could be maintained in the most scientifically useful way.
"(h)
"(i)
"(j)
"(k)
"(A) The review, summarization, and assessment of scientific evidence referred to in subsection (c).
"(B) The making of any determination, on the basis of such review and assessment, regarding the matters set out in clauses (A) through (C) of subsection (d)(1), and the preparation of the discussion referred to in subsection (d)(2).
"(C) The making of any recommendation for additional scientific study under subsection (e).
"(D) The conduct of any subsequent review referred to in subsection (f) and the making of any determination or estimate referred to in such subsection.
"(E) The preparation of the reports referred to in subsection (g).
"(2) A person referred to in paragraph (1) is-
"(A) an employee of the National Academy of Sciences or other contract scientific organization referred to in paragraph (1); or
"(B) any individual appointed by the President of the Academy or the head of such other contract scientific organization, as the case may be, to carry out any of the responsibilities referred to in such paragraph.
"(3) The cost of the liability insurance referred to in paragraph (1) shall be made from funds available to carry out this section.
"(4) The Secretary shall reimburse the Academy or person referred to in paragraph (2) for the cost of any judgments (if any) and reasonable attorney's fees and incidental expenses, not compensated by the liability insurance referred to in paragraph (1) or by any other insurance maintained by the Academy, incurred by the Academy or person referred to in paragraph (2), in connection with any legal or administrative proceedings arising out of or in connection with the work to be performed under the agreement referred to in paragraph (1). Reimbursement of the cost of such judgments, attorney's fees, and incidental expenses shall be paid from funds appropriated for such reimbursement or appropriated to carry out this section, but in no event shall any such reimbursement be made from funds authorized pursuant to section 1304 of title 31, United States Code."
"(a)
"(b)
"(1) the information compiled in accordance with subsection (a);
"(2) the Secretary's analysis of such information;
"(3) a discussion of the types and incidences of disabilities identified by the Department of Veterans Affairs in the case of veterans referred to in subsection (a);
"(4) the Secretary's explanation for the incidence of such disabilities;
"(5) other explanations for the incidence of such disabilities considered reasonable by the Secretary; and
"(6) the Secretary's views on the scientific validity of drawing conclusions from the incidence of such disabilities, as evidenced by the data compiled under subsection (a), about any association between such disabilities and exposure to dioxin or any other toxic substance referred to in section 1710(e)(1)(A) of title 38, United States Code, or between such disabilities and active military, naval, or air service, in the Republic of Vietnam during the Vietnam era.
"(c)
"(d)
"(e)
"(A) determines that it is not feasible or cost-effective to carry out this section or that carrying out this section would not make a material contribution to the body of scientific knowledge concerning the health effects in humans of herbicide exposure; and
"(B) notifies the Committees on Veterans' Affairs of the Senate and House of Representatives of the Secretary's determination and the reasons therefor.
"(2) In making a determination under this subsection, the Secretary shall give great weight to the views and recommendations of the Academy expressed in that report with respect to the implementation of this section."
"(a)
"(b)
"(c)
"(d)
"(e)
"(f)
"(A) determines that it is not feasible or cost-effective to carry out this section or that carrying out this section would not make a material contribution to the body of scientific knowledge concerning the health effects in humans of herbicide exposure; and
"(B) notifies the Committees on Veterans' Affairs of the Senate and House of Representatives of the Secretary's determination and the reasons therefor.
"(2) In making a determination under this subsection, the Secretary shall give great weight to the views and recommendations of the Academy expressed in that report with respect to the implementation of this section."
"(a)
"(1) health hazards resulting from exposure to dioxin;
"(2) health hazards resulting from exposure to other toxic agents in herbicides used in support of United States and allied military operations in the Republic of Vietnam during the Vietnam era; and
"(3) health hazards resulting from active military, naval, or air service in the Republic of Vietnam during the Vietnam era.
"(b)
"(2) The Secretary shall prescribe criteria for (A) the selection of entities to be awarded contracts or to receive financial assistance under the program, and (B) the approval of studies to be conducted under such contracts or with such financial assistance.
"(c)
"(d)
"(A) the Secretary shall consult with the Academy regarding the establishment and administration of the program under subsection (a); and
"(B) the Academy shall review the studies conducted under contracts awarded pursuant to the program and the studies conducted with financial assistance furnished pursuant to the program.
"(2) The agreement shall require the Academy to submit to the Secretary and the Committees on Veterans' Affairs of the Senate and the House of Representatives any recommendations that the Academy considers appropriate regarding any studies reviewed under the agreement.
"(e)
"(f)
"(A) determines that it is not feasible or cost-effective to carry out this section or that carrying out this section would not make a material contribution to the body of scientific knowledge concerning the health effects in humans of herbicide exposure; and
"(B) notifies the Committees on Veterans' Affairs of the Senate and House of Representatives of the Secretary's determination and the reasons therefor.
"(2) In making a determination under this subsection, the Secretary shall give great weight to the views and recommendations of the Academy expressed in that report with respect to the implementation of this section."
"(a)
"(1) has applied for medical care from the Department of Veterans Affairs; or
"(2) has filed a claim for, or is in receipt of disability compensation under chapter 11 of title 38, United States Code,
the Secretary of Veterans Affairs shall, upon the veteran's request, obtain a sufficient amount of blood serum from the veteran to enable the Secretary to conduct a test of the serum to ascertain the level of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) which may be present in the veteran's body.
"(b)
"(c)
"(d)
"(e)
"(A) determines that it is not feasible or cost-effective to carry out this section or that carrying out this section would not make a material contribution to the body of scientific knowledge concerning the health effects in humans of herbicide exposure; and
"(B) notifies the Committees on Veterans' Affairs of the Senate and House of Representatives of the Secretary's determination and the reasons therefor.
"(2) In making a determination under this subsection, the Secretary shall give great weight to the views and recommendations of the Academy expressed in that report with respect to the implementation of this section."
"(a)
"(B) The Administrator may include in the study conducted under this paragraph an evaluation of the means of detecting and treating long-term adverse health effects (particularly gender-specific health effects) found through the study.
"(2)(A) If the Administrator, in consultation with the Director of the Office of Technology Assessment, determines that it is not feasible to conduct a scientifically valid study of an aspect of the matters described in paragraph (1)-
"(i) the Administrator shall promptly submit to the appropriate committees of the Congress a notice of that determination and the reasons for the determination; and
"(ii) the Director, not later than 60 days after the date on which such notice is submitted to the committees, shall submit to such committees a report evaluating and commenting on such determination.
"(B) The Administrator is not required to study any aspect of the matters described in paragraph (1) with respect to which a determination is made and a notice is submitted pursuant to subparagraph (A)(i).
"(C) If the Administrator submits to the Congress notice of a determination made pursuant to subparagraph (A) that it is not scientifically feasible to conduct the study described in paragraph (1)(A), this section (effective as of the date of such notice) shall cease to have effect as if repealed by law.
"(3) The Administrator shall provide for the study to be conducted through contracts or other agreements with private or public agencies or persons.
"(b)
"(2) Not later than July 1, 1986, the Administrator shall publish a request for proposals for the design of the protocol to be used in conducting the study under this section.
"(3) In considering any proposed protocol for use or approval under this subsection, the Administrator and the Director shall take into consideration-
"(A) the protocol approved under section 307(a)(2)(A)(i) of the Veterans Health Programs Extension and Improvement Act of 1979 (
"(B) the experience under the study being conducted pursuant to that protocol.
"(c)
"(A) explaining the reasons for the Director's approval or disapproval of the protocol, as the case may be; and
"(B) containing the Director's conclusions regarding the scientific validity and objectivity of the protocol.
"(2) If the Director has not approved a protocol under subsection (b)(1) by the last day of the 180-day period beginning on the date of the enactment of this Act [Apr. 7, 1986], the Director-
"(A) shall, on such day, submit to the appropriate committees of the Congress a report describing the reasons why the Director has not approved such a protocol; and
"(B) shall, each 60 days thereafter until such a protocol is approved, submit to such committees an updated report on the report required by clause (A).
"(d)
"(2)(A) The Director shall submit to the appropriate committees of the Congress, at each of the times specified in subparagraph (B), a report on the Director's monitoring of the conduct of the study pursuant to paragraph (1).
"(B) A report shall be submitted under subparagraph (A)-
"(i) before the end of the 6-month period beginning on the date on which the Director approves the protocol referred to in paragraph (1);
"(ii) before the end of the 12-month period beginning on such date; and
"(iii) annually thereafter until the study is completed or terminated.
"(e)
"(f)
"(A) a description of the results obtained, before the date of such report, under the study conducted pursuant to subsection (a); and
"(B) any administrative actions or recommended legislation, or both, and any additional comments which the Administrator considers appropriate in light of such results.
"(2) Not later than 90 days after the date on which each report required by paragraph (1) is submitted, the Administrator shall publish in the Federal Register, for public review and comment, a description of any action that the Administrator plans or proposes to take with respect to programs administered by the Veterans' Administration based on-
"(A) the results described in such report;
"(B) the comments and recommendations received on that report; and
"(C) any other available pertinent information.
Each such description shall include a justification or rationale for the planned or proposed action.
"(g)
"(1) The term 'gender-specific health effects' includes-
"(A) effects on female reproductive capacity and reproductive organs;
"(B) effects on reproductive outcomes;
"(C) effects on female-specific organs and tissues; and
"(D) other effects unique to the physiology of females.
"(2) The term 'Vietnam era' has the meaning given such term in section 101(29) of title 38, United States Code."