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.
EPA Launches Section 5 application pop-up notice and CDX enhancement
03/23/2020 - The Office of Pollution Prevention and Toxics (OPPT) launched a pop-up notice in CDX to inform submitters that the absence of information in the notice may result in EPA using default values.
To learn more, call the TSCA hotline at 202-554-1404 or e-mail tsca-hotline@epa.gov.
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.
PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50) on;
- chemical identity, structure and formula
- process diagram and description
- production volume
- byproducts and impurities
- intended use
- environmental release
- disposal practices
- human exposure
- existing available test data on the effect to human health or the environment
EPA risk assessors consider all of this information during the EPA new chemicals review process. There is 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.
About Pre-manufacture Notices (PMNs)
- Is my chemical on the TSCA Inventory
- Are any new substances excluded or exempt from PMN reporting?
- Pre-Submission Meetings and Points to Consider When Preparing TSCA New Chemical Notifications
- Avoid an incomplete PMN
- Sustainable Futures Initiative
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.
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.
Limited exemptions
EPA has limited or no reporting requirements for new chemical substances in the following cases:
- Low Volume Exemption
- Research and Development Exemption
- Low Releases and Low Exposures (LoREX) Exemption
- Test Marketing Exemption
- Polymer Exemption
Pre-Submission Meetings and Points to Consider When Preparing TSCA New Chemical Notifications
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 new chemical submission and to understand the Agency’s approach to screening new chemicals for potential risks.
EPA has developed a guidance document entitled “Points to Consider When Preparing TSCA New Chemical Notifications” to explain certain common issues that arise as a part of the PMN review process. This document was updated in June 2018 to reflect comments received from the public and interested stakeholders following a December 2017 public meeting on EPA’s implementation of the new chemicals review program. EPA expects that use of this guidance will result in more robust submissions to the Agency and promote engagement and communication with EPA.
- Read EPA’s “Points to Consider When Preparing TSCA New Chemical Notifications” document and response to comments.
- Read the press release announcing the updated "Points to Consider" guidance.
- Schedule a Pre-Submission Meeting.
Avoid an incomplete PMN
May 2019 – Submitters are encouraged to carefully review EPA regulations for new chemical submissions, including 40 CFR 720.45 and 40 CFR 720.50 which provide the information that must be included in the notice form. The accuracy and completeness of the notice form improves timeliness of the new chemical review by reducing or eliminating the need to request additional information and revisions of the risk assessment.
Cases are reviewed for administrative completeness and to ensure that all required technical information concerning chemical identity has been submitted, without errors. In striving to focus attention on timely review of complete and robust notices, EPA has issued regulations at 40 CFR 720.45 and 40 CFR 720.50 which describe the specific information that must be included in the notice form. EPA will determine if the notice is required, is incomplete and/or contains errors pursuant to regulations at 40 CFR 720.62 and 40 CFR 720.65. Failure to include the specific information required by the regulations may result in EPA declaring the submission incomplete and suspending its review. EPA may declare a submission incomplete at any time during the review period where the circumstances warrant doing so under these regulations.
- Guidance for Avoiding Incomplete PMNs
- Instruction Manual for Premanufacture Notification of New Chemical Substances explains the PMN reporting requirements in detail. The instruction manual information can also be found in the help sections of the e-PMN software.
- Chemistry Assistance Manual for Premanufacture Notification Submitters
Sustainable Futures Initiative
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.
Submitting a PMN
- PMN submission
- PMN fees
- Importing and exporting new chemicals
- Confidential Business Information (CBI)
PMN submission
Submissions must be made on EPA Form 7710-25 using the electronic PMN software (e-PMN). EPA is now posting all new PMN notices and attachments submitted to the Agency after 5/31/19 in ChemView. Learn more.
- How to submit via e-PMN and CDX
- What information must be submitted
- Instruction Manual for Reporting under the TSCA Section 5 New Chemicals Program
- Questions & Answers for the New Chemicals Program (PDF)
- Consolidation of PMN submissions
- Submitting a PMN for a synthetic sequence
- Submitting a chemical intermediate
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".
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.
Contact EPA with questions about consolidating PMN submissions.
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.
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.
PMN fees
Starting October 1, 2018, fees for PMNs will be subject to the final fees rule. Learn more about TSCA section 5 fees.
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.
Confidential Business Information (CBI)
Claiming Information CBI and EPA Review of Substantiation Claims
The Frank R. Lautenberg Chemical Safety for the 21st Century Act revised TSCA section 14 concerning confidential business information (CBI) claims for information submitted to EPA.
There are new requirements relating to:
- the submission of CBI,
- periodic EPA reviews of CBI claims, and
- expiration of CBI claims.
All CBI claims must be substantiated at the time the information claimed as CBI is submitted to EPA, except for those types of information exempt under TSCA section 14(c)(2). The law requires that the submitter provide a statement concerning the need for the CBI claim and a certification that the statement of need is true and correct. There is also a requirement that when a chemical identity is claimed as CBI, a non-CBI structurally descriptive generic name be provided.
Read TSCA section 14.
Learn more about structurally descriptive generic names.
EPA must, with limited exceptions, review all CBI claims for chemical identity, as well as a representative sample of at least 25% of other claims. These reviews must occur within 90 days of receipt. Other CBI claims can also be reviewed by the Agency based on specific events.
TSCA section 5 filings are included in the universe of submissions requiring review containing CBI claims for information elements other than chemical identity. The following are some pointers that TSCA section 5 submitters should consider when making CBI claims.
- Is the TSCA CBI claim necessary? The criteria for CBI claims is set forth in 40 CFR 2.208. A central point for a CBI claim is consideration of whether the disclosure of the data element, whether alone, or in combination with other information, is likely to cause substantial harm to the business’s competitive position.
- Is the CBI claim exempt from substantiation? In a TSCA section 5 filing relating to a chemical substance not yet on the Inventory many data elements are exempt from substantiation. Learn more about elements the Agency has found to be exempt from CBI substantiation requirements.
- Is the CBI claim for health and safety data or a health and safety study? TSCA section 14(b) provides that there are limited CBI protections for these type materials. In general, study names, end points and similar information may not be claimed as CBI. EPA believes that information contained in safety data sheets, with some exceptions, generally will not qualify as CBI. Also, EPA believes that information related to worker exposure, and safety will not generally qualify as CBI. EPA has noticed circumstances where submitted studies have been claimed as CBI in their entirety. Please note that these “over-redactions” are not authorized under the statute.
- Has the submitter been consistent in its CBI claim for the data element? EPA has noticed instances where a data element has inconsistently been claimed as CBI by the same submitter. The effect of this is the CBI claim will be found invalid. This is somewhat common where company name has been claimed as CBI on a pre-manufacture notice form, but the name is not claimed as CBI in an attachment.
- If the specific chemical name is claimed as CBI, is a structurally descriptive generic name provided? EPA has observed instances of generic names being provided which do not meet this standard. EPA has also observed instances where the provided generic name is exactly the same as the actual name.
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 20-5-1Questionnaire) 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.
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.
After you submit
- Learn about EPA's process for reviewing new chemicals
- Pre-manufacture notice status
- Test guidelines for Pesticides and Toxic Substances
- After the PMN review: Notice of Commencement of manufacture or import (NOC)
- How to transfer a company's rights and liabilities to a successor under TSCA Section 5
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.
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.
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.
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.