About HPV Chemical Hazard Characterizations
This Web page describes EPA’s characterization of screening-level hazard (toxicity) data submitted to or otherwise available to the Agency on high production volume chemicals through the HPV Challenge Program. Development of these hazard characterizations is EPA's initial step to use data collected as part of the HPV program in the Agency’s efforts to protect human health and the environment from potential harm posed by HPV chemicals. Future HPV hazard characterizations will be released on a monthly basis.
How the Hazard Characterizations Are Prepared
Hazard characterizations are prepared from EPA's scientific review of the screening-level hazard data set contained within each HPV Challenge Program submission as well as data identified from a targeted search of publicly available sources of information specifically relevant to characterizing hazards. Hazard characterizations are based on available data for a specific set of "SIDS" (Screening Information Data Set) endpoints that provide basic information on the physical/chemical properties, environmental fate characteristics, and health and environmental effects of chemicals. When identified in the HPV submission or from searching publicly available sources, data for non-SIDS endpoints (e.g. irritation, sensitization, cancer, neutotoxicity and immunotoxicity) are also included in the hazard characterization. Agency reviews are performed according to established HPV Challenge Program guidelines and EPA risk assessment guidance.
Contents of Hazard Characterizations
Hazard characterizations for chemicals and chemical categories include:
- Summary of submitted data
- EPA's evaluation of the quality and completeness of the data
- EPA's determination of the potential hazards (toxicity) a chemical or chemical category may pose to human health or the environment
Background -- EPA's Process for Reviewing HPV Hazard Data
EPA is using a tiered process to prioritize and structure the review of HPV Challenge Program submissions to characterize the potential hazards of HPV chemicals. The process consists of two tiers:
- Tier I - EPA used a computerized sorting process to prioritize the HPV chemicals into first, second, and third priority groups. In doing so, EPA compared key endpoint data to established criteria. Learn more about the prioritization approach.
- Tier II - At this tier, EPA evaluates the quality and completeness of the data set contained in each HPV Challenge Program submission, identifies any data gaps, and characterizes the potential hazards of HPV chemicals. Generally, EPA's review starts with first priority chemicals; however, the Agency may choose to evaluate certain chemicals in the second and third groups earlier in the review process. The key output of Tier II is a screening-level hazard characterization for each chemical or chemical category.
Next Steps: Evaluating Risks of HPV Chemicals
In addition to continuing to prepare hazard characterization documents on the HPV chemicals, EPA has begun work on developing Risk-based Prioritization of HPV Chemicals Documents. These documents present information drawn from the screening-level Hazard Characterization, Exposure Characterization, and Risk Characterization documents prepared from submissions under the HPV Challenge Program and the 2006 Inventory Update Reporting (IUR).