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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

Filing a Pre-manufacture Notice with EPA

Warning

Do not e-mail any CBI to EPA. EPA's e-mail system is not secured to protect CBI.

Anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose is required by section 5 of the Toxic Substances Control Act (TSCA) to provide EPA with notice before initiating the activity. A pre-manufacture notice, or PMN, must be submitted at least 90 days prior to the manufacture of the chemical.

PMN submissions require all available data on

  • chemical identity
  • production volume
  • byproducts
  • use
  • environmental release
  • disposal practices
  • human exposure
  • existing available test data

EPA risk assessors consider all of this information during the EPA new chemicals review process. There are a range of actions the Agency can take to ensure new chemicals do not present an unreasonable risk to health or the environment.

Learn more about EPA's process for reviewing new chemicals under TSCA.

View a sample PMN form.

Read about who must submit a notice to EPA and refer to the flow chart that details steps for determining whether a submission is required on a chemical substance.

About Pre-manufacture Notices (PMNs)


Is my chemical on the TSCA Inventory?

Some submitters are unsure whether their chemical is already on the TSCA Inventory of Chemical Substances. If you are unsure after accessing the public TSCA Inventory, you need to contact EPA to get a determination on whether a chemical is on the inventory and you may need to submit a Bona Fide Intent to Manufacture or Import Notice.

Learn more about how to get a determination from EPA on whether a chemical is on the Inventory.

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Are any new substances excluded or exempt from PMN reporting?

Some new chemical substances are not subject to PMN reporting. These substances are either (1) excluded from TSCA reporting or (2) exempt from all or part of PMN reporting because EPA has determined that they do not warrant review or require only a short review.

Excluded Product Categories

EPA does not review new substances in the following product categories, which are excluded from TSCA authority at section 3(2)(B) of TSCA.

  • Tobacco and certain tobacco products,
  • Nuclear materials,
  • Munitions,
  • Foods, food additives, drugs, cosmetics, and
  • Substances used solely as pesticides.

These new substances fall under the jurisdiction of other federal laws and are reviewed by other federal programs. Substances used solely as pesticides are reviewed by a separate EPA Pesticides Program. In addition, the following are excluded from PMN reporting under certain conditions:

  • Naturally-occurring materials,
  • Products of incidental reactions,
  • Products of end-use reactions,
  • Mixtures (but not mixture components),
  • Impurities,
  • Byproducts,
  • Substances manufactured solely for export,
  • Nonisolated intermediates, and
  • Substances formed during the manufacture of an article.

See EPA regulations at 40 CFR section 710.4(b) for more information about scope of the TSCA Inventory.

See EPA regulations 40 CFR 720.30(a)-(h)  for more information about chemicals not subject to notification requirements. 

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Limited exemptions

EPA has limited or no reporting requirements for new chemical substances in the following cases:

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Pre-Submission Meetings

Companies are encouraged to contact EPA’s new chemicals program to set up a pre-submission meeting before submitting their PMN. The pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand the Agency’s approach to screening new chemicals for potential risks early in the review process.  EPA has developed and is seeking input on a draft “Points to Consider When Preparing TSCA New Chemical Notifications” document to explain certain common issues that arise as a part of the PMN review process.

Read EPA’s Draft “Points to Consider When Preparing TSCA New Chemical Notifications” document.

This document is a draft published for comment. Do not rely on this draft document for guidance regarding submissions under Section 5 of TSCA.

Schedule a Pre-Submission Meeting.


Qualify for regulatory relief under Sustainable Futures

The Sustainable Futures (SF) Initiative is a voluntary program that encourages chemical developers to use EPA models and methods to screen new chemicals for potential risks early in the development process. The goal is to produce safer chemicals more reliably and more quickly, saving time and money. This means getting safer chemicals into the market and in use. In some cases, it means providing alternatives to more risky chemicals — this is pollution prevention in its purest form.

Companies that take training and graduate from Sustainable Futures can earn expedited review by EPA for prescreened new chemical notices. Prescreening chemicals for hazard concerns helps companies anticipate and avoid developing chemicals of concern. Companies can instead develop and commercialize safer chemicals.

Learn about how to join EPA's Sustainable Futures program.

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Submitting a PMN


PMN submission

Submissions must be made on EPA Form 7710-25 using the electronic PMN software (e-PMN).

If the PMN submitter does not know the identity of the chemical substance, a letter of support from the supplier (e.g. a supplier of the confidential PMN or its reactants) can be used to provide the Agency with the full identity information.

Learn more about the "letter of support".

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Consolidating PMN submissions

When a potential chemical manufacturer wants to submit PMNs on several (up to six) closely similar substances, there are economies for the Agency in reviewing them together. In recognition of these economies, and to encourage manufacturers to submit such PMNs together, the Agency will only charge a fee equal to that for a single submission for a consolidated submission of up to six chemical substances.

Pre-approval before a PMN is submitted is required for a consolidated submission. Contact the New Chemicals Prenotice Coordinators for consolidation approval. Approval will be given if the substances are adequately similar chemically and toxicologically, if the planned uses are similar enough for combined review, and if intended volumes are not excessively different. Approved consolidations will be given a prenotice communication number, which must be entered on the Section 5 submission form. In some cases, a synthetic sequence can be consolidated, as well.

The Agency encourages, but has not required, that any single submission be named by Method 1. The Prenotice Coordinators will not, however, approve any consolidated submission that does not include a CAS-IES name for each substance included. Sources other than the IES have, overall, a higher error rate in generating names, and this specifically includes submitters making additional names by analogy to that of one member of an approved consolidation.

When a submission has come in incorrectly named, the process of declaring it incomplete and returning it to the submitter diverts EPA resources from other important work of the New Chemicals Program. The Method 1 requirement for consolidations is not satisfied by simply giving a CAS name and number for substances that have been previously examined by non-IES CAS personnel.

Access the New Chemicals Program roster to find the Prenotice Coordinators.

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Submitting a PMN for a synthetic sequence

When a potential chemical manufacturer wants to submit PMNs on several substances in a synthetic series leading to a final product, there are several advantages for the Environmental Protection Agency in reviewing them together: the Agency can make a more complete evaluation of likely emissions and exposure, and there are economies in the review. In recognition of these advantages, and to encourage manufacturers to submit such PMNs together, the Agency will charge a reduced fee of $1,000.00 for the submission of PMN for each chemical intermediate in a synthetic pathway when accompanied by a PMN for the final substance on that pathway. The final product is subject to a full user fee.

As is discussed elsewhere, the fee for a PMN submitted by a "small" manufacturer is reduced to $100 ("small" means less than $40 million in annual sales by the submitter company or it and its parent company together). There is no reduction in fee for intermediate PMNs filed by a "small" company to below the $100 level. It is, however, still helpful to the Agency to receive such applications together, and we encourage submitters to send them at the same time.

When several parallel synthetic sequences are being considered at once (usually this comes up when a submitter seeks approval of consolidated D, D', D", and D"', final products of the synthetic sequences A-->B-->C-->D, A'-->B'-->C' -->D', A'' B'' C'' D'', and A''' B''' C''' D''') then parallel intermediate stages (A, A', A'', and A''') can be consolidated.

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Submitting a chemical intermediate

When a potential chemical manufacturer wants to submit PMN on several substances in a synthetic series leading to a final product, there are several advantages for the Environmental Protection Agency in reviewing them together: the Agency can make a more complete evaluation of likely emissions and exposure, and there are economies in the review. In recognition of these advantages, and to encourage manufacturers to submit such PMNs together, the Agency will charge a reduced fee of $1,000.00 for the submission of PMN for each chemical intermediate in a synthetic pathway when accompanied by PMN for the final substance on that pathway. The final product is subject to a full user fee.
 
As is discussed elsewhere, the fee for a PMN submitted by a "small" manufacturer is reduced to $100 ("small" means less than $40 million in annual sales by the submitter company or it and its parent company together). There is no reduction in fee for intermediate PMNs filed by a "small" company to below the $100 level. It is, however, still helpful to the Agency to receive such applications together, and we encourage submitters to send them at the same time.
 
When several parallel synthetic sequences are being considered at once (usually this comes up when a submitter seeks approval of consolidated D, D', D", and D"', final products of the synthetic sequences A-->B-->C-->D, A'-->B'-->C' -->D', A'' B'' C'' D'', and A''' B''' C''' D''') then parallel intermediate stages (A, A', A'', and A''') can be consolidated.

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PMN fees

What is the fee for submitting?

The fee for most PMN submissions is $2,500.00. The fee is reduced under certain conditions:

  1. If your company qualifies as a small business (sales, including those of subsidiary/parent companies, are less than $40 million/year), the fee is $100.00;
  2. If a PMN for an intermediate substance is submitted with a final product PMN, the fee for the intermediate substance is $1,000.00; and
  3. If a consolidated PMN, as approved by a prenotice coordinator, is filed for multiple chemicals (no more than six) that are related, the total fee is $2,500, except that for a small business it is $100.00.

The PMN fee requirements are available at 40 CFR section 700.45. 

How do I submit PMN fees?

Fees can be paid by check, credit card, wire transfer, or bank automated clearing house (ACH).  All payments should reference the TS number applied to the notice submitted. The U.S. Department of Treasury has determined that agencies should move away from receiving payments by check only, and at some time EPA expects to be accepting payments by electronic methods only. You can already use electronic methods (i.e., credit card, wire transfer, or ACH) to pay PMN fees.

This modification to the fee payment process is due to revised Department of Treasury procedures and does not relate to any new requirements of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.”

Please note that the lockbox formerly used to accept checks (Toxic Substances Control Act User Fees P.O. Box 979073 St. Louis, MO 63197-9000) was closed based on guidance the Agency received from the U.S. Department of Treasury.  For a short time period after that box was closed, checks sent to the lockbox were returned to their senders.  If you are visiting this site because your check was returned, please contact Dave Schutz in the New Chemicals Program on 202-564-9262 or at schutz.david@epa.gov.  At this time, we have arranged that checks sent to the lockbox will be forwarded to EPA’s Washington Financial Center for processing.

  We do not yet have a date after which we will be accepting payments by electronic methods only, but we will revise our regulations at 40 CFR section 700.45 to make the regulated community aware of the change.

Payments made by check - mail checks to:

U.S. EPA – TSCA User Fees
Washington Finance Center-Collections Team
Toxic Substances Control Act User Fees
1300 Pennsylvania Ave NW MC-2733
Washington, DC  20004

Payments made using Pay.gov:

You can pay for products and services on Pay.gov directly from your checking or savings account, by credit or debit card, or by using your PayPal or Dwolla account. Access the Pay.gov form for paying TSCA fees.

Payments made by ACH to the United States Environmental Protection Agency:

Provide the following completed instructions to your financial institution.

NACHA
Record Type Code

NACHA
Field

NACHA 
Data Element  Name

Required Information

5 3 Company Name (enter remitter name)
5 6 Standard Entry Class Code CCD
5 9 Effective Entry Date (enter intended settlement date)
6 2 Transaction Code 22
6 3 & 4 Receiving DFI Identification (ABA routing #) @ 051036706
6 5 DFI Account Number 868010099000
6 6 Amount (enter payment amount)
6 8 Receiving Company Name US EPA
FEE TYPE- TSCA
TS Number

@ Bank Name: Credit Gateway – ACH Receiver 33 Livingston Ave. St. Paul, MN 55107 1-877-815-1206
 

Payments made by Fedwire transfer to the United States Environmental Protection Agency:

Provide the following completed instructions to your financial institution.

Fedwire Field Tag Fedwire Field Name Required Information
{1510} Type/Subtype 1000
{2000} Amount (enter payment amount)
{3400} Receiver ABA routing number * 021030004
{3400} Receiver ABA short name TREAS  NYC
{3600} Business Function Code CTR (or CTP)
{4200} Beneficiary Identifier (account number) 868010099000
{4200} Beneficiary Name US EPA
{5000} Originator (enter company name)
{6000} Originator to Beneficiary Information – Line 1 FEE TYPE - TSCA
{6000} Originator to Beneficiary Information – Line 2 (enter information to identify the purpose of the payment) i.e TS Number
{6000} Originator to Beneficiary Information – Line 3 (enter information to identify the purpose of the payment) i.e
{6000} Originator to Beneficiary Information – Line 4 (enter information to identify the purpose of the payment)i.e

* The financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045

Agency Contacts:

Dave Schutz, Prenotice Coordinator
US Environmental Protection Agency
Office of Pollution Prevention and Toxics
New Chemicals Management Branch
202-564-9262
Schutz.david@epa.gov

Laura Collier, Accountant
US Environmental Protection Agency
Washington Finance Center
Financial Services Division
Office of the Controller
202-564-7593
collier.laura@epa.gov

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Importing and exporting new chemicals

Imports

For the purposes of TSCA, the term “manufacture” includes import. This means that imports of new chemicals are subject to TSCA’s section 5(a) requirement to submit a pre-manufacture notice to EPA at least 90 days before importing a new chemical. In addition, under TSCA section 13, importers of new chemicals must certify that all chemical substances in the shipment comply with all applicable rules or orders under TSCA.

Learn more about TSCA import and export requirements.

Exports

Under TSCA Section 12(b), manufacturers who intend to export a chemical substance or mixture for which regulatory action has been taken under TSCA Sections 4, 5, 6, or 7 (i.e., submission of data is required, an order has been issued, or a rule has been proposed, etc.) must notify the EPA Administrator. However, any new chemical substance manufactured solely for export is not subject to notification requirements if the manufacturer knows that the person to whom the substance is being distributed intends to export or process it solely for export as defined in 40 CFR 721.3;(40 CFR 720.30(e)(2)).

Learn more about TSCA Import and Export Requirements.

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Confidential Business Information (CBI)

E-PMN and CDX allow safe CBI reporting

The e-PMN Software and EPA’s data bases are designed for you to safely transmit TSCA Confidential Business Information (TSCA-CBI) via EPA's electronic Chemical Data Exchange (CDX). As you complete the form and provide attachments, the tool automatically zips everything into one file. The tool then automatically encrypts this file and (after verifying your UserID, Password and the 20-5-1 Questionnaire) sends it through CDX to EPA. CDX is unable to open up your submission. EPA receives a matching decryption key with your submission in a secure environment. Only EPA has the matching decryption key; therefore, your TSCA-CBI is fully protected. EPA then decrypts and unzips your submission for further processing.

Do not e-mail any CBI to EPA. EPA's e-mail system is not secured to protect CBI.

Faxes and telephone calls

Companies communicating with EPA by telephone or fax are advised that the lines are not secure. When you have a telephone conversation with EPA involving confidential business information (CBI), please confirm with the EPA representative (program manager, chemist, pre-notice coordinator, etc.) that you are authorized to discuss CBI. If you are faxing CBI material to EPA, you must contact a new chemicals program staff person prior to faxing to ascertain that they are in the office that day and ready to receive the fax AND the fax must be appropriately identified by the submitter as CBI. The fax should include a cover sheet with the name of the EPA recipient and the total number of pages.

The New Chemicals Management Branch fax number is 202-564-9490.

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After you submit


Pre-manufacture notice status

EPA acknowledgement of receipt

  • When EPA receives your section 5 notice, you will be sent an acknowledgement letter that includes the notice number assigned to your submission and the date the notice review began. Submitters should expect to receive a letter from EPA providing the Day 1 for their notice within 7-10 days after receipt of their submission by the Agency.
  • If the Agency has any concerns about the substance, you will be notified before the end of the review period.
  • During the notice review period, EPA will review the section 5(a) notice and make an affirmative finding that the new chemical substance or significant new use either:
    • Presents an unreasonable risk of injury to health or the environment,
    • May present an unreasonable risk of injury to health or the environment either because the Agency has insufficient information to make an evaluation or because in the absence of sufficient information the substance may present an unreasonable risk or because the substance will be produced in substantial quantities and such substance either may enter the environment in substantial quantities, or there may be significant or substantial human exposure to the substance, or
    • Is not likely to present an unreasonable risk of injury to health or the environment.
  • EPA will make affirmative findings for all PMNs, SNUNs and MCANs, and the Agency will not "drop" review of a chemical.
  • EPA will notify submitters of its determination.
  • When EPA determines that a new chemical or significant new use is not likely to present an unreasonable risk, the Agency will notify the submitter and the submitter may commence manufacture of the chemical or manufacture or processing for a significant new use notwithstanding any remaining portion of the 90 day review period. EPA will also publish its findings in a statement in the Federal Register.
  • If EPA fails to make a determination by the end of the review period and the notice has not been withdrawn by the submitter, EPA must refund the submitter all applicable fees charged for review of the notice.

Where am I in the process?

 Many submitters want to follow the progress of their substances at intermediate points in the review process. Status reports on notices submitted to EPA under section 5 of TSCA are posted to the Status page within 14 days of a decision being made at the EPA Focus meeting.

Note: Under section 5(g) , when EPA makes a determination that a chemical substance is “not likely to present an unreasonable risk” under section 5(a)(3)(C), the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for a significant new use notwithstanding any remaining portion of the applicable review period.

In addition to posting the decisions made by EPA for PMNs and LVEs on this Status page, EPA will post the status of Significant New Use Notices (SNUNs) (SN), Test Market Exemption Applications (T), Low Release/Low Exposure Exemptions (LoRex)(X), Low Volume Modifications (LM), and LoRex Modifications (XM).

New chemicals are added to the TSCA Inventory after the PMN review period has completed and the PMN submitter has commenced nonexempt commercial manufacture.

Find out the current status of PMNs, SNUNs and exemption notices under review by EPA.

Find out the status of biotech submissions.

View the TSCA Inventory.

Note that the public version of the TSCA Inventory is updated every six months, so the most recent notices of commencement may not be reflected.

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After the PMN review: filing a notice of commencement of manufacture or import (NOC)

  • The submitter of the PMN must provide a Notice of Commencement of Manufacture or Import Form (NOC) to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.
  • NOCs must be submitted electronically to EPA. 
  • The chemical substance is considered to be on the TSCA Inventory as soon as a complete NOC is received by EPA. Actual EPA processing of the NOC to complete the transaction takes about four weeks.
  • R&D substances: Excess R&D substance may be used or sold after expiration of the PMN review period and does not require submission of an NOC. The substance will not be placed on the Inventory until an NOC is received; however, an NOC may not be submitted for the substance before commercial manufacture (non-R&D) begins.

Learn about requirements for submitting an NOC electronically.

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How to transfer a company's rights and liabilities to a successor under TSCA Section 5

"Transfer notice" requirement

  • Various business needs may dictate the need to change the legal ownership or corporate identity of the chemical manufacturer subsequent to EPA's processing of a TSCA section 5 notice. This can arise in many ways, including mergers, acquisitions, corporate restructuring, asset purchases, etc. EPA has developed the forms below to facilitate the process of having such transfers reported to, and accepted by, EPA.
  • "Transfer Notice" forms authorize successor rights and liabilities of manufacture of new chemicals subject to prior TSCA section 5 notices.
  • In general, section 5(e) Consent Orders signed after mid-1996 contain "successor liability" requirements including submission of a "Notice of Transfer" form, whereas Orders issued before then do not.
  • For older Orders lacking a "Notice of Transfer" form, EPA recommends using the section 5(e) Consent Order Transfer Notice form provided below.
  • Note that EPA's policy is that section 5(e) Consent Orders may be transferred from the original Company to a Successor in Interest only after EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN substance from the Company pursuant to 40 CFR 720.102.
  • If the transfer from the Company to the Successor in Interest is effective before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a new PMN to EPA and comply fully with section 5(a)(1) of TSCA and 40 CFR part 720 before commencing manufacture or import of the PMN substance.

Access "Transfer Notice" forms.

Learn about requirements for submitting a Notice of Transfer electronically.

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