Highlights
September 5, 2012 -- EPA is proposing to add two microorganisms (specific strains of the fungus Trichoderma reesei and specific subspecies of the bacterium Bacillus amyloliquefaciens) to the list of 10 recipient microorganisms (40 C.F.R. 725.420) that are eligible for exemptions from full chemical notification requirements under the Toxic Substances Control Act (TSCA). EPA will take comments on the proposal until November 5, 2012. Read the proposed rule.
August 15, 2012 -- EPA published a significant new use rule (SNUR)(PDF) (38 pp, 349K, about PDF) for 25 chemical substances that were the subject of premanufacture notices (PMNs).
August 1, 2012 -- EPA held a webinar on the e-PMN version 2.0 software.
July 25, 2012 -- EPA withdrew a significant new use rule (SNUR)(PDF) (2 pp, 202K, about PDF) for the chemical substances that were the subject of the premanufacture notices (PMNs) P-01-384, P-01-385, P-01-386, P-01-387, and P-01-388.
Important Information
WARNING - DO NOT e-mail any Confidential Business Information (CBI) to EPA. EPA's e-mail system is NOT secured to protect CBI.
All new PMNs and SNUNs, as well as support documents (for notices submitted after April 6, 2010), must be provided to EPA via ePMN and CDX.
SNUN reminder: When submitting a Significant New Use Notice (SNUN), companies should include a cover letter. Read more information about SNUNs and what the cover letter should include.
Note: Having a Chemical Abstract Services Registry Number (CASRN) for a chemical does not equate to that chemical being listed on the TSCA Inventory.
Speak to a Specialist
The Toxic Substances Control Act Hotline (tsca-hotline@epa.gov) can answer questions about the PMN process or filing a PMN form.
Call (202) 554-1404
Monday to Friday: 8:30 a.m. - 5:00 p.m. EST
FAX (202) 554-5603
Mandated by section 5 of the Toxic Substances Control Act (TSCA), EPA's Program helps manage the potential risk to human health and the environment from chemicals new to the marketplace. The program functions as a "gatekeeper" that can identify conditions, up to and including a ban on production, to be placed on the use of a new chemical before it is entered into commerce. Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by section 5 of TSCA to provide EPA with notice before initiating the activity. This premanufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.
This Web site provides information on how the PMN process works and on related programs, including the existing chemicals programs under TSCA and the Sustainable Futures Initiative, which shows companies how to use the new chemicals program's computer models to screen PMNs or exemption notices before they submit them to EPA.
Find out more about various parts of the program:
Before the PMN Process Starts- Who is Required to Notify?
- PMN Forms and Information
- PMN Instruction Manual (PDF) (51 pp, 721K, about PDF)
- TSCA Inventory
- Filing Exclusions/Exemptions
- Chemistry Assistance Manual
- What Information to Submit
- PMN Fees
- Confidential Business Information
- Mailing/Courier Instructions
- Rejection Policy for Incompletes
- What Happens to My PMN?
- Meetings and Review Process
- People to Contact
- Exposure-Based Policy
- PBT Policy
- High Molecular Weight Polymers Policy
- Handling Proprietary Information
- Assessing Potential Risk
- Exposure Assessment Tools/Models
- Chemical Categories
- Possible Outcomes
- Consent Orders/SNURs
- Significant New Use Notices (SNUNs)
- Consent Order Boilerplates
- New Chemical Exposure Limits (NCELs)
- Notice of Commencement
- Successor Transfer
- EPA-OCSPP Harmonized Test Guidelines
- Summary of Accomplishments
- Existing Chemicals
- Nanotechnology under the Toxic Substances Control Act
- Biotechnology
- Sustainable Futures Initiative
- Pollution Prevention and New Chemicals
- P2 Recognition
- Design for the Environment
- Green Chemistry
- International Chemical Safety
- Waste and Chemical Enforcement Division
- OECD New Chemicals Directory
- OECD test guidelines