TSCA Exemptions: Polymer, R&D, TME, LVE, LoREX

Section 5 of the Toxic Substances Control Act (TSCA) requires anyone who intends to manufacture or import a new substance in the United States to submit a premanufacture notification (PMN) in advance of beginning their activity. However, certain exemptions exist which may provide an alternative to a full PMN filing, in many cases saving time and money.

Intertek’s team of experienced regulatory specialists, chemists, toxicologists and engineers can assist you in understanding the various available exemptions and develop a TSCA compliance strategy best suited to meet your needs.

Polymer Exemption

Substances which meet the TSCA polymer definition are exempt from notification, in an effort to encourage the production of safe polymers in the United States. If your polymer meets the definition, you are exempt from a full notification, but instead must keep specific records.

Intertek’s expert regulatory chemists can help you navigate the complexities of the polymer definition and determine if this is an exemption you can pursue.

Research and Development Exemption

TSCA permits the manufacture or import of a new chemical substance without notification if that substance is only intended for use in specific research and development activities and only in small quantities. However, it is the responsibility of the manufacturer (or importer) to prove that their activities are within the EPA definition of R&D. 

Intertek’s regulatory affairs experts can help you work within the R&D Exemption criteria by:

• reviewing your proposed activities against the R&D definition
• assisting in the evaluation of potential risk
• providing guidance on what is considered “sufficient” recordkeeping

Test Marketing Exemption (TME)
If you have an intent to test the market for a new substance to determine if there is customer interest, a TSCA exemption exists which allows you to undertake that activity without filing a full PMN. Unlike the previous exemptions, however, this exemption requires notification to and approval by the EPA before activities may begin. 

If you want to pursue this route, Intertek’s chemists, toxicologists and regulatory affairs experts can assist in:

• investigating the hazard potential of the substance using existing, analogue and QSAR data
• compiling required information regarding production, distribution and use
• preparing the Test Marketing Exemption Application (TMEA) using the EPA’s online submission tool.

Exemptions for Low Volumes, Low Releases or Low Exposure (LVE and LoREX)
In the interest of encouraging manufacturers and importers to employ practices which reduce risk to humans and the environment, reduced registration requirements are available if the submitter is willing to limit their product volumes or is able to show that their operations minimize exposure to workers, the public and the environment.

Intertek’s experts can strategize with you as to how to employ practices to meet these exemption criteria and can assist in the preparation of the required registration dossiers.