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Background on EPA Section 4 Orders

As part of the TSCA Risk Evaluation process under Section 4(a)(1), EPA may issue specific requirements for developing information about chemicals in order to determine whether they present an unreasonable risk of injury to health or the environment. These orders include requirements that companies that manufacture and/or process the specified chemicals must provide additional information to enable robust characterization of environmental and occupational exposures. The importance of transparency and representativeness of data when conducting risk evaluations has been emphasized in public comments, with many stakeholders urging EPA to include more refined exposure analyses in subsequent risk evaluations.

As of February 16, 2021, EPA has issued test orders for ten chemistries subject to evaluation under TSCA, nine of which became effective on January 19^th, 2021 (see the complete list here). The orders detail areas of insufficient data that may introduce bias or uncertainty into the risk evaluation and request companies to provide additional information in order to improve the robustness and specificity of the risk evaluation process. Specific types of testing required in the recently issued test orders include:

• Environmental Hazard Testing (e.g., OECD 233)
• Occupational Inhalation Exposure Testing (e.g., NIOSH Method 1003)
• Occupational Dermal Exposure Testing (e.g., OECD 428--Dermal Hand Wipe Sampling)

Companies that receive EPA test orders have 45 days from the effective date to respond, and must indicate which of five options they have chosen in order to comply with the order:

1. Develop the information;
2. Submit existing information that they believe EPA has not considered;
3. Request an extension;
4. Claim that they are not subject to the order; or
5. Cease the chemical manufacture or processing.

Considerations for Companies

Companies subject to the orders may face certain practical challenges with expanding or refining their environmental and occupational sampling plans in order to satisfy EPA’s requirements. Such considerations include:

• Knowledge-sharing with other companies, and the option to form a consortium with other companies in the allotted response period;
• Cost and logistical challenges related to developing robust and transparent sampling plans; and
• Time required to develop and execute sampling plans.

Implications for Other Chemistries

EPA’s current orders are likely to set a precedent for other chemicals listed on the TSCA inventory. Becoming familiar with similarities in the recently issued orders now provides a rare opportunity for manufacturers and processors of other TSCA inventory chemicals to consider early actions in anticipation of future orders that may affect their chemicals.

Cardno ChemRisk scientists have extensive professional experience evaluating the possible hazards and risks posed by chemicals in occupational settings, and particularly in regards to TSCA Test Order requirements. Please contact Dr. Marisa Kreider and Ms. Heather Lynch for more information on our capabilities regarding TSCA, and Ms. Rachel Zisook, CIH for more information on our capabilities regarding occupational health and safety.