Chemicals, Regulatory Developments

Updated Guidance on TSCA Section 5 Submissions

As part of its efforts to improve implementation of the amended Toxic Substances Control Act (TSCA), EPA’s Office of Pollution Prevention and Toxics (OPPT) has updated its guidance document, Points to Consider When Preparing TSCA New Chemical Notifications. The EPA notes that it has incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the update.

The intent of the guidance is to inform submitters about all the information they must and should include when submitting Premanufacture Notices (PMN), Significant New Use Notices (SNUN), or exemption notices (e.g., Low Volume Exemption (LVE)) under TSCA Section 5. 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 to conduct an efficient review.

Shortage of Details

The EPA uses the information in PMN, SNUN, and exemption notice submittals in Section 5 reviews, which can result in one or several determinations, including that the new chemical or new use does or does not present an unreasonable risk to human health or the environment. The speed with which the Agency completes Section 5 reviews is dependent on the amount and quality of information it has received from the submitters. The Agency says it has identified two basic scenarios that often lead to delays in reviewing notifications in the New Chemical Review process:

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

Avoid Follow-Up Submissions

“Notifications that lack detail typically result in follow-up or additional interaction with submitters, which in turn, adds time to the New Chemical Review process,” the Agency states in the guidance. “If the submitter provides additional information, EPA 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.”

Test Data—Required and Additional

EPA regulations at 40 Code of Federal Regulations (CFR) part 720 list the information that must be submitted on EPA Form 7710-25. There are three general categories of required information: chemical identity and physical-chemical property information; domestic production, import, and use information; and test data. While the EPA sees insufficient data in each of these categories, the test data category appears to present the major challenge to submitters.

The regulations require submission of “all test data in the submitter’s possession or control” that are related to the effects on health or the environment of any manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance or any mixture or article containing the new chemical substance or any combination of such activities. This includes test data concerning the new chemical substance in a pure, technical grade, or formulated form.

The guidance notes that the required test data to be submitted can be supplemented to expedite the review.

“In addition to providing the required test data, submitters may consider providing full study reports, if available, of any other test data the submitter considers to be important for EPA to consider, e.g., test data on analogs,” says the Agency. “Providing full studies streamlines the review process and allows EPA assessors to determine study quality, completeness and suitability and to evaluate study outcomes.”

Prenotice Meetings

In addition, the Agency encourages prospective submitters to contact EPA’s new chemicals program to set up a presubmission (or prenotice) meeting before making Section 5 submissions. “The pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand the Agency’s approach to reviewing new chemicals for potential risks early in the process,” states the EPA.

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