38 U.S.C.   Sec. 1116  

-CITE-

    38 USC Sec. 1116                                            01/19/04

-EXPCITE-

    TITLE 38 - VETERANS' BENEFITS

    PART II - GENERAL BENEFITS

    CHAPTER 11 - COMPENSATION FOR SERVICE-CONNECTED DISABILITY OR DEATH

    SUBCHAPTER II - WARTIME DISABILITY COMPENSATION

-HEAD-

    Sec. 1116. Presumptions of service connection for diseases

      associated with exposure to certain herbicide agents; presumption

      of exposure for veterans who served in the Republic of Vietnam

-STATUTE-

      (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.

-SOURCE-

    (Added Pub. L. 102-4, Sec. 2(a)(1), Feb. 6, 1991, 105 Stat. 11,

    Sec. 316; renumbered Sec. 1116 and amended Pub. L. 102-83, Sec.

    5(a), (c)(1), Aug. 6, 1991, 105 Stat. 406; Pub. L. 103-446, title

    V, Sec. 505, title XII, Sec. 1201(e)(6), Nov. 2, 1994, 108 Stat.

    4664, 4685; Pub. L. 104-275, title V, Sec. 505(b), Oct. 9, 1996,

    110 Stat. 3342; Pub. L. 106-419, title IV, Sec. 404(a)(1), Nov. 1,

    2000, 114 Stat. 1864; Pub. L. 107-103, title II, Sec. 201(a)(1)(A),

    (b)-(c)(2)(A), (d)(1), Dec. 27, 2001, 115 Stat. 987, 988.)

-REFTEXT-

                            REFERENCES IN TEXT                        

      Section 3 of the Agent Orange Act of 1991, referred to in

    subsecs. (b)(2) and (c)(1)(A), is section 3 of Pub. L. 102-4, which

    is set out below.

-MISC1-

                                AMENDMENTS                            

      2001 - Pub. L. 107-103, Sec. 201(c)(2)(A), amended section

    catchline generally. Prior to amendment, catchline read as follows:

    "Presumptions of service connection for diseases associated with

    exposure to certain herbicide agents".

      Subsec. (a)(2)(F). Pub. L. 107-103, Sec. 201(a)(1)(A), struck out

    "within 30 years 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" before period at end.

      Subsec. (a)(2)(H). Pub. L. 107-103, Sec. 201(b), added subpar.

    (H).

      Subsec. (a)(3), (4). Pub. L. 107-103, Sec. 201(c)(1)(B),

    redesignated par. (4) as (3). Former par. (3) redesignated as

    subsec. (f).

      Subsec. (e). Pub. L. 107-103, Sec. 201(d)(1), substituted "on

    September 30, 2015" for "10 years after the first day of the fiscal

    year in which the National Academy of Sciences transmits to the

    Secretary the first report under section 3 of the Agent Orange Act

    of 1991".

      Subsec. (f). Pub. L. 107-103, Sec. 201(c)(1)(A), (C),

    redesignated subsec. (a)(3) as (f), substituted "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" for "For the

    purposes of this subsection, a veteran", and struck out "and has a

    disease referred to in paragraph (1)(B) of this subsection" after

    "May 7, 1975,".

      2000 - Subsec. (a)(2)(F). Pub. L. 106-419 inserted "of

    disability" after "to a degree".

      1996 - Subsec. (a)(1)(A). Pub. L. 104-275, Sec. 505(b)(2),

    substituted "during the period beginning on January 9, 1962, and

    ending on May 7, 1975" for "during the Vietnam era".

      Subsec. (a)(1)(B). Pub. L. 104-275, Sec. 505(b)(1), substituted

    "during the period beginning on January 9, 1962, and ending on May

    7, 1975," for "during the Vietnam era".

      Subsec. (a)(2)(C), (E), (F). Pub. L. 104-275, Sec. 505(b)(2),

    substituted "during the period beginning on January 9, 1962, and

    ending on May 7, 1975" for "during the Vietnam era".

      Subsec. (a)(3). Pub. L. 104-275, Sec. 505(b)(1), substituted

    "during the period beginning on January 9, 1962, and ending on May

    7, 1975," for "during the Vietnam era".

      Subsec. (a)(4). Pub. L. 104-275, Sec. 505(b)(2), substituted

    "during the period beginning on January 9, 1962, and ending on May

    7, 1975" for "during the Vietnam era".

      1994 - Subsec. (a)(1)(B). Pub. L. 103-446, Sec. 1201(e)(6),

    substituted "(i)" for "(1)" and "(ii)" for "(2)".

      Subsec. (a)(2)(D) to (G). Pub. L. 103-446, Sec. 505, added

    subpars. (D) to (G).

      1991 - Pub. L. 102-83, Sec. 5(a), renumbered section 316 of this

    title as this section.

      Subsec. (a)(1). Pub. L. 102-83, Sec. 5(c)(1), substituted "1110"

    for "310" and "1113" for "313" in introductory provisions.

                     EFFECTIVE DATE OF 2001 AMENDMENT                 

      Pub. L. 107-103, title II, Sec. 201(a)(1)(B), Dec. 27, 2001, 115

    Stat. 987, provided that: "The amendment made by subparagraph (A)

    [amending this section] shall take effect January 1, 2002."

                     EFFECTIVE DATE OF 1996 AMENDMENT                 

      Amendment by Pub. L. 104-275 effective Jan. 1, 1997, with no

    benefit to be paid or provided by reason of such amendment for any

    period before such date, see section 505(d) of Pub. L. 104-275, set

    out as a note under section 101 of this title.

    REPORT ON TIME LIMIT FOR PRESUMPTION OF CANCER CAUSED BY HERBICIDE

                                   AGENT

      Pub. L. 107-103, title II, Sec. 201(a)(2)-(4), Dec. 27, 2001, 115

    Stat. 987, provided that:

      "(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."

                AGREEMENT WITH NATIONAL ACADEMY OF SCIENCES            

      Section 3 of Pub. L. 102-4, as amended by Pub. L. 102-83, Sec.

    5(c)(2), Aug. 6, 1991, 105 Stat. 406; Pub. L. 102-86, title V, Sec.

    503(a), (b)(1), Aug. 14, 1991, 105 Stat. 424, 425; Pub. L. 107-103,

    title II, Sec. 201(d)(2), Dec. 27, 2001, 115 Stat. 988, provided

    that:

      "(a) Purpose. - The purpose of this section is to provide for the

    National Academy of Sciences, an independent nonprofit scientific

    organization with appropriate expertise which is not part of the

    Federal Government, to review and evaluate the available scientific

    evidence regarding associations between diseases and exposure to

    dioxin and other chemical compounds in herbicides.

      "(b) Agreement. - The Secretary shall seek to enter into an

    agreement with the National Academy of Sciences for the Academy to

    perform the services covered by this section. The Secretary shall

    seek to enter into such agreement not later than two months after

    the date of the enactment of the Veterans' Benefits Programs

    Improvement Act of 1991 [Aug. 14, 1991].

      "(c) Review of Scientific Evidence. - Under an agreement between

    the Secretary and the National Academy of Sciences under this

    section, the Academy shall review and summarize the scientific

    evidence, and assess the strength thereof, concerning the

    association between exposure to an herbicide used in support of the

    United States and allied military operations in the Republic of

    Vietnam during the Vietnam era and each disease suspected to be

    associated with such exposure.

      "(d) Scientific Determinations Concerning Diseases. - (1) For

    each disease reviewed, the Academy shall determine (to the extent

    that available scientific data permit meaningful determinations) - 

        "(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) Recommendations for Additional Scientific Studies. - The

    Academy shall make any recommendations it has for additional

    scientific studies to resolve areas of continuing scientific

    uncertainty relating to herbicide exposure. In making

    recommendations for further study, the Academy shall consider the

    scientific information that is currently available, the value and

    relevance of the information that could result from additional

    studies, and the cost and feasibility of carrying out such

    additional studies.

      "(f) Subsequent Reviews. - An agreement under subsection (b)

    shall require the National Academy of Sciences - 

        "(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) Reports. - (1) The agreement between the Secretary and the

    National Academy of Sciences shall require the Academy to transmit

    to the Secretary and the Committees on Veterans' Affairs of the

    Senate and House of Representatives periodic written reports

    regarding the Academy's activities under the agreement. Such

    reports shall be submitted at least once every two years (as

    measured from the date of the first report).

      "(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) Limitation on Authority. - The authority to enter into

    agreements under this section shall be effective for a fiscal year

    to the extent that appropriations are available.

      "(i) Sunset. - This section shall cease to be effective on

    October 1, 2014.

      "(j) Alternative Contract Scientific Organization. - If the

    Secretary is unable within the time period prescribed in subsection

    (b) to enter into an agreement with the National Academy of

    Sciences 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 is not part of the Government and

    operates as a not-for-profit entity and that has expertise and

    objectivity comparable to that of the National Academy of Sciences.

    If the Secretary enters into such an agreement with another

    organization, then any reference in this section and in section

    1116 [formerly 316] of title 38, United States Code (as added by

    section 2), to the National Academy of Sciences shall be treated as

    a reference to the other organization.

      "(k) Liability Insurance. - (1) The Secretary may provide

    liability insurance for the National Academy of Sciences or any

    other contract scientific organization to cover any claim for money

    damages for injury, loss of property, personal injury, or death

    caused by any negligent or wrongful act or omission of any person

    referred to in paragraph (2) in carrying out any of the following

    responsibilities of the Academy or such other organization, as the

    case may be, under an agreement entered into with the Secretary

    pursuant to this section:

        "(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."

    RESULTS OF EXAMINATIONS AND TREATMENT OF VETERANS FOR DISABILITIES

    RELATED TO EXPOSURE TO CERTAIN HERBICIDES OR TO SERVICE IN VIETNAM

      Section 6 of Pub. L. 102-4, as amended by Pub. L. 102-83, Sec.

    5(c)(2), Aug. 6, 1991, 105 Stat. 406, provided that:

      "(a) In General. - Subject to subsections (d) and (e), the

    Secretary of Veterans Affairs shall compile and analyze, on a

    continuing basis, all clinical data that (1) is obtained by the

    Department of Veterans Affairs in connection with examinations and

    treatment furnished to veterans by the Department after November 3,

    1981, by reason of eligibility provided in section 1710(e)(1)(A) of

    title 38, United States Code, and (2) is likely to be

    scientifically useful in determining the association, if any,

    between the disabilities of veterans referred to in such section

    and exposure to dioxin or any other toxic substance referred to in

    such section or between such disabilities and active military,

    naval, or air service in the Republic of Vietnam during the Vietnam

    era.

      "(b) Annual Report. - The Secretary shall submit to the

    Committees on Veterans' Affairs of the Senate and the House of

    Representatives an annual report containing - 

        "(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) First Report. - The first report under subsection (b) shall

    be submitted not later than one year after the effective date of

    this section [see subsec. (e) of this section].

      "(d) Funding. - The authority of the Secretary to carry out this

    section is effective in any fiscal year only to the extent or in

    the amount specifically provided in statutory language in

    appropriations Acts.

      "(e) Effective Date. - (1) This section shall take effect at the

    end of the 90-day period beginning on the date on which the first

    report of the National Academy of Sciences under section 3(g) [set

    out above] is received by the Secretary, except that this section

    shall not take effect if the Secretary, after receiving that report

    and before the end of that 90-day period - 

        "(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."

                          TISSUE ARCHIVING SYSTEM                      

      Section 7 of Pub. L. 102-4 provided that:

      "(a) Establishment of System. - Subject to subsections (e) and

    (f), for the purpose of facilitating future scientific research on

    the effects of exposure of veterans to dioxin and other toxic

    agents in herbicides used in support of United States and allied

    military operations in the Republic of Vietnam during the Vietnam

    era, the Secretary of Veterans Affairs shall establish and maintain

    a system for the collection and storage of voluntarily contributed

    samples of blood and tissue of veterans who performed active

    military, naval, or air service in the Republic of Vietnam during

    the Vietnam era.

      "(b) Security of Specimens. - The Secretary shall ensure that the

    tissue is collected and stored under physically secure conditions

    and that the tissue is maintained in a condition that is useful for

    research referred to in subsection (a).

      "(c) Authorized Use of Specimens. - The Secretary may make blood

    and tissue available from the system for research referred to in

    subsection (a). The Secretary shall carry out this section in a

    manner consistent with the privacy rights and interests of the

    blood and tissue donors.

      "(d) Limitations on Acceptance of Samples. - The Secretary may

    prescribe such limitations on the acceptance and storage of blood

    and tissue samples as the Secretary considers appropriate

    consistent with the purpose specified in subsection (a).

      "(e) Funding. - The authority of the Secretary to carry out this

    section is effective in any fiscal year only to the extent or in

    the amount specifically provided in statutory language in

    appropriations Acts.

      "(f) Effective Date. - (1) This section shall take effect at the

    end of the 90-day period beginning on the date on which the first

    report of the National Academy of Sciences under section 3(g) [set

    out above] is received by the Secretary, except that this section

    shall not take effect if the Secretary, after receiving that report

    and before the end of that 90-day period - 

        "(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."

              SCIENTIFIC RESEARCH FEASIBILITY STUDIES PROGRAM          

      Section 8 of Pub. L. 102-4 provided that:

      "(a) Establishment of Program. - Subject to subsections (e) and

    (f), the Secretary of Veterans Affairs shall establish a program to

    provide for the conduct of studies of the feasibility of conducting

    additional scientific research on - 

        "(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) Program Requirements. - (1) Under the program established

    pursuant to subsection (a), the Secretary shall, pursuant to

    criteria prescribed pursuant to paragraph (2), award contracts or

    furnish financial assistance to non-Government entities for the

    conduct of studies referred to in subsection (a).

      "(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) Report. - The Secretary shall promptly report the results of

    studies conducted under the program to the Committees on Veterans'

    Affairs of the Senate and the House of Representatives.

      "(d) Consultation With the National Academy of Sciences. - (1) To

    the extent provided under any agreement entered into by the

    Secretary and the National Academy of Sciences under this Act [Pub.

    L. 102-4, see Short Title of 1991 Amendments note under section 101

    of this title] - 

        "(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) Funding. - The authority of the Secretary to carry out this

    section is effective in any fiscal year only to the extent or in

    the amount specifically provided in statutory language in

    appropriations Acts.

      "(f) Effective Date. - (1) This section shall take effect at the

    end of the 90-day period beginning on the date on which the first

    report of the National Academy of Sciences under section 3(g) [set

    out above] is received by the Secretary, except that this section

    shall not take effect if the Secretary, after receiving that report

    and before the end of that 90-day period - 

        "(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."

               BLOOD TESTING OF CERTAIN VIETNAM-ERA VETERANS           

      Section 9 of Pub. L. 102-4, as amended by Pub. L. 102-83, Sec.

    5(c)(2), Aug. 6, 1991, 105 Stat. 406, provided that:

      "(a) Blood Testing. - Subject to subsections (d) and (e), in the

    case of a veteran described in section 1710(e)(1)(A) of title 38,

    United States Code, who - 

        "(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) Notification of Test Results. - Upon completion of such

    test, the Secretary shall notify the veteran of the test results

    and provide the veteran a complete explanation as to what, if

    anything, the results of the test indicate regarding the likelihood

    of the veteran's exposure to TCDD while serving in the Republic of

    Vietnam.

      "(c) Incorporation in System. - The Secretary shall maintain the

    veteran's blood sample and the results of the test as part of the

    system required by section 7 [set out above].

      "(d) Funding. - The authority of the Secretary to carry out this

    section is effective in any fiscal year only to the extent or in

    the amount specifically provided in statutory language in

    appropriations Acts, but such amount shall not exceed $4,000,000 in

    any fiscal year.

      "(e) Effective Date. - (1) This section shall take effect at the

    end of the 90-day period beginning on the date on which the first

    report of the National Academy of Sciences under section 3(g) [set

    out above] is received by the Secretary, except that this section

    shall not take effect if the Secretary, after receiving that report

    and before the end of that 90-day period - 

        "(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."

      STUDY OF EFFECT OF VIETNAM EXPERIENCE ON HEALTH STATUS OF WOMEN

                             VIETNAM VETERANS

      Pub. L. 99-272, title XIX, Sec. 19031, Apr. 7, 1986, 100 Stat.

    385, provided that:

      "(a) Requirement for Epidemiological Study. - (1)(A) Except as

    provided in paragraph (2), the Administrator of Veterans' Affairs

    shall provide for the conduct of an epidemiological study of any

    long-term adverse health effects (particularly gender-specific

    health effects) which have been experienced by women who served in

    the Armed Forces of the United States in the Republic of Vietnam

    during the Vietnam era and which may have resulted from traumatic

    experiences during such service, from exposure during such service

    to phenoxy herbicides (including the herbicide known as Agent

    Orange), to other herbicides, chemicals, or medications that may

    have deleterious health effects, or to environmental hazards, or

    from any other experience or exposure during such service.

      "(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) Approval of Protocol. - (1) The study required by subsection

    (a) shall be conducted in accordance with a protocol approved by

    the Director of the Office of Technology Assessment.

      "(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

      (Public Law 96-151; 38 U.S.C. 219 note [1116 note]); and

        "(B) the experience under the study being conducted pursuant to

      that protocol.

      "(c) OTA Reports. - (1) Concurrent with the approval or

    disapproval of any protocol under subsection (b)(1), the Director

    shall submit to the appropriate committees of the Congress a report

    - 

        "(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) OTA Monitoring of Compliance. - (1) In order to ensure

    compliance with the protocol approved under subsection (b)(1), the

    Director shall monitor the conduct of the study under subsection

    (a).

      "(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) Duration of Study. - The study conducted pursuant to

    subsection (a) shall be continued for as long after the date on

    which the first report is submitted under subsection (f)(1) as the

    Administrator determines that there is a reasonable possibility of

    developing, through such study, significant new information on the

    health effects described in subsection (a)(1).

      "(f) Reports. - (1) Not later than 24 months after the date of

    the approval of the protocol pursuant to subsection (b)(1) and

    annually thereafter, the Administrator shall submit to the

    appropriate committees of the Congress a report containing - 

        "(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) Definitions. - For the purposes of this section:

        "(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."

          AGENT ORANGE STUDY; REPORT TO CONGRESSIONAL COMMITTEES      

      Pub. L. 96-151, title III, Sec. 307, Dec. 20, 1979, 93 Stat.

    1097, as amended by Pub. L. 97-72, title IV, Sec. 401, Nov. 3,

    1981, 95 Stat. 1061; Pub. L. 98-542, Sec. 8(a), Oct. 24, 1984, 98

    Stat. 2731, directed that a protocol be designed for an

    epidemiological study of the long-term health effects of Agent

    Orange on Armed Forces personnel who served in Vietnam, and that

    reports be submitted to Congress describing results with comments

    and recommendations.

-SECREF-

                   SECTION REFERRED TO IN OTHER SECTIONS               

      This section is referred to in sections 1103, 1113 of this title.

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