November 5, 2013 -- EPA removed significant new use rules (SNURs) for three chemical substances that were the subject of premanufacture notices (PMNs) P-12-539, P-13-107, and P-13-109.
October 17, 2013 -- Toxic Substances Control Act Section 5 New Chemical and Significant New Use Notifications: Delay in Processing Due to Lack of Authorized Funding; Extension of Review Periods
Due to a lapse of appropriations and the Agency shutdown, EPA is extending (pursuant to TSCA sections 5(c) and 26(c) and 40 CFR 720.75(c)) the review periods for all TSCA section 5 Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Microbial Commercial Activity Notices (MCANs), and exemption notices that were submitted to the Agency under section 5 of the Toxic Substances Control Act (TSCA; 15 U.S.C. section 2604) before October 1, 2013, and for which the review period has not expired as of October 1, 2013.
There is a possibility that the chemical substances submitted for review in these TSCA section 5 notifications may need to be regulated by EPA under TSCA. The Agency requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents, should regulatory action be required. Therefore, EPA has determined that good cause exists to extend, under TSCA section 5(c), the review period for each such TSCA section 5 notification.
The duration of this extension period is equivalent to the duration of the shutdown, i.e., equivalent to the number of days accruing from October 1, 2013, and the date on which this shutdown terminated on October 16, 2013, and EPA operations resumed on October 17, 2013, or a total of 16 days.
Also, during the shutdown, new notifications submitted on or after October 1, 2013, through E-PMN/CDX or other methods were not processed. Consequently, the review period for any TSCA section 5 notice submitted during the shutdown did not begin until operations resumed on October 17, 2013. Information on the duration of the furlough can be found on www.opm.gov.
September 11, 2013 -- EPA published a final significant new use rule (SNUR) for three chemical substances that were the subject of premanufacture notices (PMNs) P-10-58, P-10-59, and P-10-60.
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 (email@example.com) 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 New Chemicals 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. Section 5 of TSCA requires anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose 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
- Guidance Materials for PMN Submitters
- 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
- 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