§ 1173. Formal evaluation of recommendations

• (a) 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) 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)
  • (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) 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.