Updated Guidance on TSCA New Chemical Notifications

The EPA’s Office of Pollution Prevention and Toxics has updated its guidance document, Points to Consider When Preparing TSCA New Chemical Notifications, as part of its efforts to improve implementation of the amended Toxic Substances Control Act (TSCA). The guidance is intended to provide new chemical submitters with information on:

• general guidance relating to new chemical notices;
• preparation of Pre-manufacture Notices (PMN), Significant New Use Notices (SNUN), and Exemption notices;
• EPA scientific approaches; and
• best practices.

New chemical submitters that provide the Agency with comprehensive data will likely see their products brought to the marketplace more quickly and less expensively than those that do not provide the Agency with everything it needs.

Causes for Delay

The EPA has identified two basic scenarios that often lead to delays in reviewing notifications in the New Chemical Review process:

1. The provided information lacks specific details, which precludes EPA from using the information in lieu of generally conservative assumptions.
2. Additional information, which would aid EPA with refining its assumptions, are not provided by the submitter in the original notice, are not in the possession or control of the submitter or are not generated until after the initiation or completion of the New Chemical Review process.

Notifications that lack detail typically result in follow-up or additional interaction with submitters, adding time to the New Chemical Review process. If the submitter provides additional information, EPA states that it will generally conduct additional analyses and/or re-evaluate the notification in light of the additional information. In an effort to ensure that notifications are not delayed, EPA “encourages submitters to review and to consult this document while preparing their notifications, so they understand the utility of submitting complete information with the original submission.”

According to EPA, if submitters fail to submit the required information when they complete and file their notifications, EPA may declare the notice to be incomplete and the review period will not begin. EPA states that if sufficiently specific information is lacking, it “typically makes conservative assumptions, which oftentimes lead to the practice of delayed reviews and frequent suspensions while submitters work with the Agency to provide and/or develop additional information.” The guidance is intended to reduce the frequency of such delays.

Possible Determinations

The guidance lists the following possible determinations that EPA will reach under TSCA Section 5(a)(3):

1. The new chemical substance or significant new use presents an unreasonable risk of injury to human health or the environment (Section 5(a)(3)(A));
2. The information on the new chemical substance or significant new use is insufficient to make a reasoned evaluation of the health and environmental effects (Section 5(a)(3)(B)(i));
3. In the absence of sufficient information, the new chemical substance may present an unreasonable risk of injury to health or the environment (Section 5(a)(3)(B)(ii)(I));
4. The new chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance (Section 5(a)(3)(B)(ii)(II)); or
5. The new chemical substance or significant new use is not likely to present an unreasonable risk of injury to human health or the environment (Section 5(a)(3)(C)).

For more information, visit EPA’s website.