# § 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.
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**Source Credit**: (Added Pub. L. 117–168, title II, § 202(a), Aug. 10, 2022, 136 Stat. 1769.)