Sound science in regulations act

Tenn. Code Ann. § 4-5-232, under Rulemaking and Publications.

Tenn. Code Ann. § 4-5-232

(a) (a) An agency shall not adopt a rule establishing numeric criteria or numeric limitations applicable to a contaminant, pollutant, hazardous substance, solid waste, or hazardous waste, as those terms are defined in title 68 and 69, that relates to drinking water, water pollution control, hazardous substances, contaminated site remediation, air quality, or solid or hazardous waste handling unless:(1) Scientific and technical information relied on to support the rule is based upon the best available science; and(2) With respect to human health, the best available science establishes a direct link, based on generally accepted scientific practice, to manifest bodily harm in humans. In the absence of data from voluntary scientific studies on humans, best available science can be based on tests performed on experimental animal species or human and animal cells that indicate exposure at or above the numeric criteria or numeric limits establishes a direct link, based on generally accepted scientific practice, to manifest bodily harm in humans.(b) For purposes of this section:(1) “Best available science” means science that:(A) Is reliable, unbiased, and reasonably applies to the agency's rule;(B) Maximizes the quality, objectivity, and integrity of information, including statistical information; human, animal, and other relevant scientific studies; and, if applicable, human health risk-based assessments; and(C) Involves the use of supporting studies conducted in accordance with generally accepted scientific or technical practices utilizing data collected by generally accepted methods or best available methods and that are:(i) Site-specific studies, including area-wide or statewide studies;(ii) Studies published in a refereed journal;(iii) External peer-reviewed studies contained in a federal government report published for a purpose other than development of the agency's rule; or(iv) Maximum contaminant levels (MCLs), Regional Screening Levels (RSLs), and vapor intrusion screen levels (VISLs) published by the United States environmental protection agency; provided, however, the levels may not be used to establish numeric criteria or numeric limitations that are lower than the MCLs, RSLs, or VISLs or that apply to environmental media, contaminants, pollutants, hazardous substances, solid wastes, or hazardous wastes different than those that are the subject of the MCLs, RSLs, or VISLs; and(2) “Refereed journal” means a publication that:(A) Uses an editorial board or critical review panel of subject matter experts in the relevant scientific or technical disciplines who critically and objectively assess the methodology and analysis of submitted scientific studies in a nonpartisan fashion and provide editorial services prior to publication; and(B) Takes meaningful steps to avoid biases in its scientific review process.(c) This section only applies to agency rules adopted on or after July 1, 2025, that are more stringent than any applicable federal regulation or adopted in the absence of a federal regulation.(d) This section does not apply to:(1) Any rule required by federal law, including rules adopted in furtherance of federal agency primacy requirements;(2) Any rule that is the substantive equivalent to a federal regulation;(3) Any rule of the department of agriculture or the department of health; or(4) Emergency rules promulgated pursuant to § 4-5-208.

(a) An agency shall not adopt a rule establishing numeric criteria or numeric limitations applicable to a contaminant, pollutant, hazardous substance, solid waste, or hazardous waste, as those terms are defined in title 68 and 69, that relates to drinking water, water pollution control, hazardous substances, contaminated site remediation, air quality, or solid or hazardous waste handling unless:(1) Scientific and technical information relied on to support the rule is based upon the best available science; and(2) With respect to human health, the best available science establishes a direct link, based on generally accepted scientific practice, to manifest bodily harm in humans. In the absence of data from voluntary scientific studies on humans, best available science can be based on tests performed on experimental animal species or human and animal cells that indicate exposure at or above the numeric criteria or numeric limits establishes a direct link, based on generally accepted scientific practice, to manifest bodily harm in humans.

(1) Scientific and technical information relied on to support the rule is based upon the best available science; and

(2) With respect to human health, the best available science establishes a direct link, based on generally accepted scientific practice, to manifest bodily harm in humans. In the absence of data from voluntary scientific studies on humans, best available science can be based on tests performed on experimental animal species or human and animal cells that indicate exposure at or above the numeric criteria or numeric limits establishes a direct link, based on generally accepted scientific practice, to manifest bodily harm in humans.

(b) For purposes of this section:(1) “Best available science” means science that:(A) Is reliable, unbiased, and reasonably applies to the agency's rule;(B) Maximizes the quality, objectivity, and integrity of information, including statistical information; human, animal, and other relevant scientific studies; and, if applicable, human health risk-based assessments; and(C) Involves the use of supporting studies conducted in accordance with generally accepted scientific or technical practices utilizing data collected by generally accepted methods or best available methods and that are:(i) Site-specific studies, including area-wide or statewide studies;(ii) Studies published in a refereed journal;(iii) External peer-reviewed studies contained in a federal government report published for a purpose other than development of the agency's rule; or(iv) Maximum contaminant levels (MCLs), Regional Screening Levels (RSLs), and vapor intrusion screen levels (VISLs) published by the United States environmental protection agency; provided, however, the levels may not be used to establish numeric criteria or numeric limitations that are lower than the MCLs, RSLs, or VISLs or that apply to environmental media, contaminants, pollutants, hazardous substances, solid wastes, or hazardous wastes different than those that are the subject of the MCLs, RSLs, or VISLs; and(2) “Refereed journal” means a publication that:(A) Uses an editorial board or critical review panel of subject matter experts in the relevant scientific or technical disciplines who critically and objectively assess the methodology and analysis of submitted scientific studies in a nonpartisan fashion and provide editorial services prior to publication; and(B) Takes meaningful steps to avoid biases in its scientific review process.

(1) “Best available science” means science that:(A) Is reliable, unbiased, and reasonably applies to the agency's rule;(B) Maximizes the quality, objectivity, and integrity of information, including statistical information; human, animal, and other relevant scientific studies; and, if applicable, human health risk-based assessments; and(C) Involves the use of supporting studies conducted in accordance with generally accepted scientific or technical practices utilizing data collected by generally accepted methods or best available methods and that are:(i) Site-specific studies, including area-wide or statewide studies;(ii) Studies published in a refereed journal;(iii) External peer-reviewed studies contained in a federal government report published for a purpose other than development of the agency's rule; or(iv) Maximum contaminant levels (MCLs), Regional Screening Levels (RSLs), and vapor intrusion screen levels (VISLs) published by the United States environmental protection agency; provided, however, the levels may not be used to establish numeric criteria or numeric limitations that are lower than the MCLs, RSLs, or VISLs or that apply to environmental media, contaminants, pollutants, hazardous substances, solid wastes, or hazardous wastes different than those that are the subject of the MCLs, RSLs, or VISLs; and

(A) Is reliable, unbiased, and reasonably applies to the agency's rule;

(B) Maximizes the quality, objectivity, and integrity of information, including statistical information; human, animal, and other relevant scientific studies; and, if applicable, human health risk-based assessments; and

(C) Involves the use of supporting studies conducted in accordance with generally accepted scientific or technical practices utilizing data collected by generally accepted methods or best available methods and that are:(i) Site-specific studies, including area-wide or statewide studies;(ii) Studies published in a refereed journal;(iii) External peer-reviewed studies contained in a federal government report published for a purpose other than development of the agency's rule; or(iv) Maximum contaminant levels (MCLs), Regional Screening Levels (RSLs), and vapor intrusion screen levels (VISLs) published by the United States environmental protection agency; provided, however, the levels may not be used to establish numeric criteria or numeric limitations that are lower than the MCLs, RSLs, or VISLs or that apply to environmental media, contaminants, pollutants, hazardous substances, solid wastes, or hazardous wastes different than those that are the subject of the MCLs, RSLs, or VISLs; and

(i) Site-specific studies, including area-wide or statewide studies;

(ii) Studies published in a refereed journal;

(iii) External peer-reviewed studies contained in a federal government report published for a purpose other than development of the agency's rule; or

(iv) Maximum contaminant levels (MCLs), Regional Screening Levels (RSLs), and vapor intrusion screen levels (VISLs) published by the United States environmental protection agency; provided, however, the levels may not be used to establish numeric criteria or numeric limitations that are lower than the MCLs, RSLs, or VISLs or that apply to environmental media, contaminants, pollutants, hazardous substances, solid wastes, or hazardous wastes different than those that are the subject of the MCLs, RSLs, or VISLs; and

(2) “Refereed journal” means a publication that:(A) Uses an editorial board or critical review panel of subject matter experts in the relevant scientific or technical disciplines who critically and objectively assess the methodology and analysis of submitted scientific studies in a nonpartisan fashion and provide editorial services prior to publication; and(B) Takes meaningful steps to avoid biases in its scientific review process.

(A) Uses an editorial board or critical review panel of subject matter experts in the relevant scientific or technical disciplines who critically and objectively assess the methodology and analysis of submitted scientific studies in a nonpartisan fashion and provide editorial services prior to publication; and

(B) Takes meaningful steps to avoid biases in its scientific review process.

(c) This section only applies to agency rules adopted on or after July 1, 2025, that are more stringent than any applicable federal regulation or adopted in the absence of a federal regulation.

(d) This section does not apply to:(1) Any rule required by federal law, including rules adopted in furtherance of federal agency primacy requirements;(2) Any rule that is the substantive equivalent to a federal regulation;(3) Any rule of the department of agriculture or the department of health; or(4) Emergency rules promulgated pursuant to § 4-5-208.

(1) Any rule required by federal law, including rules adopted in furtherance of federal agency primacy requirements;

(2) Any rule that is the substantive equivalent to a federal regulation;

(3) Any rule of the department of agriculture or the department of health; or

(4) Emergency rules promulgated pursuant to § 4-5-208.