What is a low volume exemption TSCA?

Certain categories of new low-volume chemical substances are exempt from full premanufacture notice (PMN) review under section 5 of the Toxic Substances Control Act (TSCA), i.e., chemicals manufactured at 10,000 kg/year or less. More than one manufacturer may hold a Low-Volume Exemption (LVE) for the same substance.

What chemicals are exempt from TSCA?

Drugs, cosmetics, foods, food additives, pesticides, and nuclear materials are exempt from TSCA. Learn more about TSCA. TSCA gives EPA authority to take specific measures to assess chemical substances and mixtures, and protect against unreasonable risks to human health and the environment from existing chemicals.

What is an LVE?

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Are you required to submit a pre manufacture notice if you plan to manufacture a new chemical strictly for the purposes of research and development?

You must notify EPA in advance of manufacture of a new chemical substance as required under section 5 of the TSCA for commercial distribution of a new substance which is no longer within the ambit of the R&D exemption.

What are the low volume exemptions under TSCA?

Certain categories of new low-volume chemical substances are exempt from full premanufacture notice (PMN) review under section 5 of the Toxic Substances Control Act (TSCA), i.e., chemicals manufactured at 10,000 kg/year or less.

When to apply for a low volume exemption?

EPA will perform its risk assessment at the lower PV, if the corresponding binding box has been marked. More than one manufacturer may hold a Low-Volume Exemption (LVE) for the same substance.

When to submit a LVE modification to TSCA?

Manufacturers must submit an LVE modification 30 days prior to a change in: Site of manufacture – includes changes from import to domestic manufacture as well as changes in contract manufacturers – except as provided at 723.50 (j) (6);

What are new chemical substances subject to TSCA?

Chemical substances manufactured in or imported into the United States that are not listed on the TSCA Inventory and that are not otherwise exempt from TSCA Inventory listing are considered “new” chemical substances subject to TSCA Section 5 PMN requirements. What are the exemptions from PMN requirements?