Preliminary assessment information rule (PAIR)
- Under PAIR, producers and importers of a listed chemical are required to report certain site-specific information.
Under TSCA, which covers the production, distribution, use, and disposal of chemical substances, EPA’s Office of Pollution Prevention and Toxics is charged with the responsibility for assuring that chemicals made available for sale and use in the U.S. do not pose any unreasonable adverse risks to human health or to the environment. To carry out this mandate, EPA has broad authority to issue regulations designed to gather health/safety and exposure information on, require testing of, and control exposure to chemical substances and mixtures.
TSCA section 8(a) requirements
TSCA section 8(a), Reporting and Retention of Information, gives EPA the authority to promulgate rules under which manufacturers (which by statute includes importers) and processors of chemical substances must maintain records and/or report such data as EPA may reasonably require in order to carry out the TSCA mandates. Examples of information that can be required to be reported under TSCA section 8(a) include:
- Chemical or mixture identity;
- Categories of use;
- Quantity manufactured or processed;
- By-product description;
- Health and environmental effects information;
- Number of individuals exposed; and
- Method(s) of disposal.
Section 8(a) regulations can be tailored to meet unique information needs (e.g., via chemical-specific rules) or information can be obtained via the use of “model” or standardized reporting rules.
Preliminary Assessment Information Rule (PAIR)
The PAIR requirements at 40 CFR 712 is one example of a model TSCA section 8(a) reporting rule. Under PAIR, producers and importers of a listed chemical are required to report the following site-specific information:
- Quantity of chemical produced and/or imported;
- Amount of chemical lost to the environment during production or importation;
- Quantity of enclosed, controlled, and open releases of the chemical; and
- Per release, the number of workers exposed and the number of hours exposed.
Respondents are only required to report information that is known or reasonably ascertainable by them. Extensive file searches are not required. The PAIR reporting requirements are included in the PAIR form (EPA Form 7710-35) and instructions.
Exemptions for such reporting are as follows:
- Production or importation for the sole purpose of research and development;
- Production or importation of less than 500 kilograms during the reporting period at a single plant site;
- Companies whose total annual sales from all sites owned by the domestic or foreign parent company are below $30 million for the reporting period and who produced or imported less than 45,400 kilograms of the chemical; and
- Production or importation of the listed chemical solely as an impurity, a non-isolated intermediate, and under certain circumstances as a by-product.
EPA uses PAIR to collect information to help identify, assess, and manage human health and environmental risks caused by the manufacture or importation of identified chemical substances, mixtures, and categories. PAIR is also available to EPA for the purpose of informing the prioritization and risk evaluation activities.
EPA or other federal agencies (e.g., the agencies that are part of the Interagency Testing Committee (ITC) as authorized under TSCA section 4(e)) can identify chemicals for a TSCA section 8(a) PAIR expediated rulemaking that have a justifiable need for production, use, or exposure-related data.