TSCA Premanufacture Notices - Everything You Need to Know!

TSCA Premanufacture Notices - Everything You Need to Know!

TSCA Premanufacture Notices - Everything You Need to Know!

FAQs About the Toxic Substance Control Act (TSCA)

1. A FIFRA registered pesticide is added as a preservative to a formulated product which then is sold as a rubber lubricant. Since the pesticide is now part of a mixture, must it be on the TSCA Inventory?

No, if the use of the registered pesticide as a preservative is considered a pesticidal use as defined by FIFRA then the pesticide ingredient would not be subject to PMN or Inventory reporting under TSCA. However, if the pesticide is not registered for use as a preservative, then it is a violation of FIFRA to use it as such. The mixture including the rubber lubricant is, however, subject to possible TSCA regulation.

2. If a chemical is produced solely for use as an inert ingredient under FIFRA, is it subject to TSCA?

Inert ingredients produced or used in the manufacture of a pesticide are substances or mixtures which can be regulated under TSCA. In order to be considered a pesticide, a substance must be intended for use as a pesticide. Inert ingre4dients produced or used in the manufacture of a pesticide are not themselves regulated under FIFRA (unless they happen to be pesticides themselves) and therefore, are subject to TSCA.

However, once the inert ingredient is placed in the pesticide product it comes under FIFRA's jurisdiction as part of a pesticide product. That is, under FIFRA, EPA may prevent a substance from being included as an inert ingredient in a pesticide product.

3. If one purchased a TSCA listed material and then determined that the material also contained an unlisted material, what can be done by the purchaser who has a commercial intent to use the material?

Section 15(2) of TSCA states that it is unlawful for any person to use for commercial purposes a chemical substance which the person knew, or had reason to know, was manufactured, processed, or distributed in violation of TSCA.

However, if the unlisted substance meets the definition of an impurity under 40 CFR 720.3, that material need not be listed on the TSCA Inventory.

In cases where the new substance is determined not to be an impurity, the manufacturer must submit a PMN and may be subject to any subsequent enforcement action.

4. Are hydraulic fluids contained inside a sealed unit, e.g. an automobile shock absorber or refrigeration fluid inside an air conditioner, considered an article since they are not intended for release? What about motor oil in an imported automobile?

Hydraulic fluid in automobile shock absorbers, refrigeration fluid in air conditioners, and motor oil in imported automobiles are considered "part" of an article and therefore are exempt from PMN requirements and from TSCA 13 import certfication. These fluids are considered to be "part" of the article because they are not intended to be released or removed from the article and have no end use or commercial purpose separate from the article.

5. What is an impurity?

An impurity is a chemical substance which is unintentionally present with another chemical substance. If an "impurity" enhances the product or is manufactured itself for a commercial purpose, it would no longer be viewed as an impurity. It may in fact become a co-product; as such, a PMN would be required prior to manufacture (import) for a commercial purpose if the substance is not listed on the TSCA Chemical Substance Inventory.

6. What are the categories that have predetermined risks for new compounds? Is this published?

The New Chemicals Program (NCP) has developed 36 categories of concern to facilitate the PMN review process. The categories identify testing schemes as well as other risk management options to control human exposures and environmental releases. Copies of the categories of concern may be requested from the TSCA Hotline at 202-554-1404.

7. Do you have a list of projects?

Yes, you can obtain a copy by submitting a Freedom of Information Act (FOIA) request or by contacting Wanda Vasquez at 212-637-3668.