Table 1 Overview of Consensus Principles and Recommendations for Health-Protective Chemical Policy

The financial burden of data generation for a chemical on (or to be introduced to) the market should be on the chemical producers benefiting from their production and use

• Generate health effects data for chemicals on the market and new chemicals prior to entry on the market that allow full health assessment of workplace, consumer, fenceline, and general population exposures

• Require manufacturers to provide physical and chemical properties data and chemical standards

• Ensure financial burden of data generation for chemicals (already on market or prior to entry) is borne by the manufacturer and under the supervision of the regulator

Lack of data does not equate to lack of hazard, exposure, or risk

• Develop a set of properties to assess completeness of the database for a given chemical – such as physical and chemical properties, exposure parameters for current or past uses, and health endpoints (including for highly susceptible and exposed subpopulations) and identify gaps in the existing data

• Ensure adequate and up-to-date monitoring, modeling, and toxicity data

• Evaluations of hazard data based on newer methods such as computational and in vitro approaches should be used primarily to identify early signals of harm, and hazard concerns should only be downgraded if there is robust evidence in multiple systems to ensure that hazard classifications are not weakened based on speculative or limited data, but rather to provide “actionable evidence” to support regulatory restrictions

• EPA should make greater use of its authority under TSCA Sects. 4, 8, and 10 to obtain data on chemicals in commerce

• EPA should re-evaluate industry’s confidential business information (CBI) claims to ensure that critical hazard data are not shielded from public view

• Incentivize data generation using approaches such as publishing provisional toxicity values for chemicals that apply multiple default adjustment factors to fully account for missing data

• Action should be taken to mitigate exposures and evaluate the potential harmful impacts of chemicals with evidence of harm over their full life cycle, even when there is not a full hazard and risk assessment or when evidence is limited

Populations at greater risk, including those that are more susceptible or more highly exposed, must be better identified and protected to account for their real-world risks

• Explicitly identify factors that qualify groups as susceptible subpopulations

• Integrate ground-truthed knowledge and community-generated data on uses, exposures, and hazards from community experts into scientific evaluations

• Rely on best available methods to account for factors that increase susceptibility when identifying hazards, estimating exposures, and quantitatively estimating dose–response relationships

• EPA should use an expanded definition of “potentially exposed or susceptible subpopulations” to ensure health risks are appropriately considered and quantified

• Consult with community experts early and often and incorporate their expert knowledge in hazard and risk assessments

• Account for aggregate exposure and cumulative risk in all risk assessments

Hazard and risk assessments should not assume existence of a “safe” or “no-risk” level of chemical exposure in the diverse general population

• Use risk assessment methods that quantify health risks at low levels of exposures to chemicals, unless there are sufficient data to demonstrate a threshold level below which there is no risk for the entire exposed population

• Apply methods to quantify risks of non-cancer effects and replace the reference dose (RfD) and reference concentration (RfC) with a risk-specific dose

Hazard and risk assessments must evaluate and account for financial conflicts of interest (COI) in the body of evidence

• Evaluations of study quality in hazard and risk assessments should account for the potential influence on study outcomes of study authors or study sponsors with a financial conflict of interest

• Government agencies should identify and implement policies to reduce financial conflict of interest in the scientific evidence base for decision making