TSCA Section 4 Test Orders
Section 4 of the Toxic Substances Control Act (TSCA) allows EPA to require chemical manufacturers (including importers) and processors to develop information on chemicals and submit such information to EPA.
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Overview of Section 4 Test Orders
Under section 4(a), EPA may issue an order requiring the development of information on a chemical if EPA makes certain statutorily-required findings. For example, EPA may issue an order if the Agency finds that the chemical may present an unreasonable risk of injury to health or the environment and such information is needed to determine whether the chemical presents such an unreasonable risk.
Additionally, EPA may also issue an order under section 4(a) requiring the development of information to support certain federal activities (e.g., to review a notice submitted under TSCA section 5 or to perform a risk evaluation under TSCA section 6(b)). Further details about orders EPA has issued are available on the List of Chemicals Subject to Section 4 Test Orders webpage.
Developing section 4 test orders is a complex and resource-intensive process involving many scientific and regulatory considerations. The document below describes the process of developing, drafting, and issuing section 4 test orders.
Section 4(a)(1)Test Orders
TSCA Section 4(a)(1) authorizes EPA to issue an Order where insufficient information exists, testing is necessary to get that information, and
- the chemical substance may present unreasonable risk, or
- the chemical substance is produced in substantial quantities and may cause substantial or significant exposures to the environment or humans.
Currently, EPA is using its National PFAS Testing Strategy to identify important gaps in existing data and to select one or more candidate chemicals within identified categories for additional study. EPA is taking a phased approach to issuing test orders pursuant to the strategy beginning with human health effects on representative test substances for 24 PFAS categories in Phase I. The first test order was issued in June 2022, and the agency plans to issue additional Phase I orders in the coming months.
As indicated above, developing section 4 test orders is a complex and resource-intensive process involving many scientific and regulatory considerations. Additionally, EPA is considering what testing is required, and appropriate, based on a given PFAS-testing candidate’s physical and chemistry properties.
Section 4(a)(2) Test Orders
Under TSCA Section 4(a)(2), EPA may issue an order requiring the development of
information:
- to review a notice submitted under TSCA section 5 or to perform a risk evaluation under TSCA section 6(b);
- to implement a requirement imposed in a rule, order, or consent agreement under TSCA section 5(e) or (f), or in a rule promulgated under section 6(a);
- at the request of a Federal implementing authority under another Federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure;
- to determine if a chemical substance or mixture manufactured, processed, or distributed in commerce solely for export presents an unreasonable risk of injury to health or the environment in the U.S., pursuant to TSCA section 12(a)(2); and
- to prioritize a chemical substance under TSCA section 6(b) (subject to certain limitations).
In January 2021, EPA issued orders on nine chemical substances to address data needs relating to risk evaluations. EPA issued additional orders on eight of these chemical substances in March 2022 to address remaining data needs. These orders are available on the List of Chemicals Subject to Section 4 Test Orders webpage.
Resources for Recipients of Test Orders
Find user guides on Test Order reporting via the CDX web platform.
Presentation: TSCA Section 4 Test Orders (pdf)
Test Orders Under TSCA Section 4: Questions and Answers (pdf)
Policies Regarding Manufacturers and Processors Subject to TSCA Section 4(a) Testing (pdf)
Removal of Certain Companies from Seven TSCA Section 4(a)(2) Orders Issued in 2022 (pdf)