What is a PMN chemical?
Anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required to submit a pre-manufacture notice (PMN) at least 90 days prior to the manufacture of the chemical.
What chemicals are subject to TSCA?
Six chemical substances receive special attention under TSCA: PCBs, asbestos, radon, lead, mercury, and formaldehyde.
What does it mean to be listed on TSCA?
The Toxic Substances Control Act (TSCA) Chemical Substance Inventory contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA.
What is CBI in EPA?
A: This Notice provides your business with instructions about how to assert a claim of confidentiality (or confidential business information (CBI) claim) covering information submitted to or obtained by EPA during or after its inspection (or other compliance monitoring).
What is a premanufacture notice?
PREMANUFACTURE NOTIFICATION. Page 1. PREMANUFACTURE NOTIFICATION. Laboratories are responsible for determining whether a substance you intend to import or manufacture is a “new” chemical substance as defined by TSCA (40 CFR 720.3).
What is not subject to TSCA?
Chemicals NOT Subject to TSCA Regulation Pesticides regulated under FIFRA (the federal pesticide regulation) Tobacco and tobacco products regulated under the ATF. Radioactive materials regulated by the NRC. Foods, food additives, drugs, and cosmetics regulated by the FDA.
Why was the TSCA created?
The push to regulate toxic substances began in 1971 when the President’s Council on Environmental Quality released a report on Toxic Substances and noted that there was a need for comprehensive legislation that would identify and control potentially dangerous chemicals.
What products does TSCA apply to?
TSCA specifically exempts from the definition of “chemical substance” (1) mixtures (although mixtures of chemical substances can be regulated under certain provisions of TSCA and chemical substance components of mixtures are themselves covered under TSCA provisions that apply to “chemical substance”); (2) Federal …
Who must comply with TSCA?
What is the TSCA Chemical Data Reporting rule? The TSCA Chemical Data Reporting (CDR) rule (40 C.F.R. Part 711) requires manufacturers and importers to provide EPA with information on the production and use of chemicals in commerce.
Does TSCA apply to medical devices?
Reporting generally is required for any substance produced in or imported into the U.S., but there are a number of important exemptions. Reporting is not required for pesticide products, food, drugs, cosmetics, medical devices and quantities of substances imported or manufactured solely for research and development.
What is a CBI request?
Request for disclosure of confidential business information (CBI)
What is considered CBI?
CBI is broadly defined as proprietary information, considered confidential to the submitter, the release of which would cause substantial business injury to the owner.