Regulatory Library

EPA’s New Chemicals Program Under TSCA: The Basics

The New Chemicals Program is the U.S. Environmental Protection Agency’s (EPA) program for management of potential risk from chemicals new to commerce. The New Chemicals Program is mandated by Section 5 of the Toxic Substances Control Act (TSCA). Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required under TSCA Section 5 to provide the EPA with notice before initiating the activity. This article presents an overview of the current New Chemicals Program and how the EPA reviews and proceeds under this program. The reader may also be interested in learning more about SOCMA’s PMNPro, a service specializing in helping companies navigate the new chemicals program at EPA. Click here to learn more.  Additional information sources are linked at the end.

What is the New Chemicals Program?


The New Chemicals Program has been developed by the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxic Substances (OPPT) for the purpose of managing potential risks from chemicals new to commerce. This program is mandated by Section 5 of the Toxics Substances Control Act (TSCA). The New Chemicals Program functions as a "gatekeeper" which 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 submit a premanufacture notice (PMN) to the EPA before initiating the activity. Chemical importers (but not exporters) should be aware that their requirements under TSCA are exactly the same as those of domestic chemical manufactures.

The EPA classifies chemical substances as either "existing" chemicals or "new" chemicals. The best way to determine if the substance you are working with is a new chemical is by consulting the EPA's Chemical Substance Inventory under the TSCA (commonly referred to as the TSCA Inventory or just the Inventory). Any substance that is not on the Inventory is classified as a "new" chemical, which means that it is not already in commence in the U.S. If a substance is new, it can be immediately manufactured for a commercial purpose only if it is subject either to an exemption from PMN reporting or to a TSCA reporting exclusion (for example, a Low Volume Exemption (LVE), or exclusion as a naturally-occurring material). For substances that are "existing", the Inventory can be used to determine if there are restrictions on manufacture or use under the TSCA. There are approximately 80,000 chemical substances (as defined in Section 3 of the TSCA) on the Inventory at this time.

Which New Chemical Substances are Exempted from PMN Reporting?

Under the EPA’s New Chemicals Program, some new chemicals 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 the EPA has determined that they do not warrant review or require only a short review.

The 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, foods additives, drugs, cosmetics, and substances used solely as pesticides. These new substances fall under the jurisdiction of other federal laws such as the Food Quality Protection Act or the Federal Insecticide, Fungicide, and Rodenticide Act, and are therefore reviewed by other federal programs. 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, non-isolated intermediates, and substances formed during the manufacture of an article.

Who Must Submit a PMN?

A chemical company must submit a PMN to the EPA when it intends to manufacture or import a new chemical substance for a commercial purpose. The company must submit a notice if it intends to import a new substance in bulk form or as part of a mixture, but not if it intends to import the substance only as part of an article.

For the purpose of TSCA, "import" is considered to be the same as "manufacture". Under the TSCA, importers need a TSCA statement on any imported chemicals. PMNs for importing new chemical substances should be submitted by the principal importer to the EPA. "Principal importer" is defined at 40 Code of Federal Regulations (CFR), and it should be noted that it is not necessarily the same thing as "Importer of Record" under U.S. Customs Service regulations.

When Should a PMN be Submitted?

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 PMN must be submitted at least 90 days prior to the manufacture or import of the chemical.

New chemical manufacturers are required to submit a notice for Low Volume Exemption (LVE) or Low Release and Exposure Exemption (LoREX) 30 days before commencing with manufacture or import of a new chemical substance, and 45 days before manufacture or importation under Test-Market Exemption (TME). If information additional to that provided with the application is needed, these periods can be extended through suspension requests. If the application is not denied, a company will be able to initiate manufacture or import at the end of these review periods. It is prudent for submitters who think that their chemical substances may be subjected to required additional testing during PMN review to confer with the EPA before submitting a PMN, and to submit further in advance of the hoped-for start dates rather than the minimum numbers of days for review, as additional testing will extend the EPA review period for the PMN. To initiate this process, just contact a Prenotice Coordinator.

What Information Must Be Submitted about New Chemical Substances?

PMN submissions require all available data on chemical identity, production volume, by- products, use, environmental release, disposal practices, and human exposures. If the identity of some reactants for substance synthesis is unknown to the manufacture, a letter of support can be used to enable the EPA to have full identity information.

PMN submission must be made on the EPA Form 7710-25-part 1, part 2. The EPA also requires that the following information be submitted with the PMN: all existing health and environmental data in the possession of the submitter, parent company, or affiliates, and a description of any other relevant health or environmental data known to or reasonably ascertainable by the submitter. Information frequently requested by the New Chemicals Program for chemicals of commonly submitted types is identified in the chemical categories document. All of this information is considered by the EPA risk assessors to determine whether the likely risk is unreasonable. The New Chemicals Program can require submission of any additional data, including development of data through testing, when the information included with the PMN, coupled with that available to its risk reviewers from internal archives, is not adequate to clarify for the EPA whether the likely risk is unreasonable.

What are the Possible Outcomes of a PMN Review?


Upon receipt of the PMN by the OPPT Document Control Officer (DCO), the EPA will make an initial determination whether the notice is complete. The initial determination is designed to determine that the notice addresses all the items required on the form and any apparent chemical identity problems. If no problems are foreseen, the forms are initially determined to be "complete" and go on for further agency review. If the notice is initially complete, a submitter will receive an acknowledgment letter listing the notice number and the date of expiration of the review period. During the review period, the EPA-assigned Program Manager may contact applicants for clarification of information that was provided in the PMN or if the EPA identifies issues of concern. The Program Manager will also notify a submitter before the review period expires if he/she intends to expand the review period, or if regulatory action is being considered on the new chemical substance. If the submitter is not contacted prior to the expiration of the review period, he/she may commence manufacture of the substance identified in the notice after the review period has expired. A PMN submitter can check the status of the submission at the New Chemicals program website after approximately 30 days following receipt of the PMN by OPPT.

The EPA may issue a TSCA Section 5(e) Order to prohibit or limit activities associated with the substance, if the EPA determines that:
 

  • there is "insufficient information" to evaluate the human health and environmental effects of the substance, and
  • that the substance may present an unreasonable risk of injury to human health or the environment (the "risk-based" finding), or
  • that the substance will be produced in substantial quantities and may be anticipated to enter the environment in substantial quantities, or there may be significant or substantial human exposure (the "exposure-based" finding).
In practice, these Section 5(e) Orders are almost always issued as "Consent Orders" that are signed by both the EPA and the chemical manufacturer. Given the "insufficient information" finding, most Section 5(e) Orders require the PMN submitter to develop and submit to the EPA certain toxicity or environmental fate tests before exceeding a specified production volume ("test trigger") designed to allow sales of the chemical to generate enough revenue to pay for the testing. Exposure-based Section 5(e) Orders consist primarily of a requirement to conduct triggered testing (plus record keeping and "risk notification" in case the test data indicates a risk.) Risk-based TSCA Section 5(e) Orders, depending on the type of concerns identified by EPA for a given PMN substance, typically also require exposure controls such as gloves, goggles, respirators, specified disposal technologies or restrictions on releases to water, and hazard communication such as material safety data sheets (MSDS), labels, and work training.

Conclusion

The EPA’s New Chemicals Program under the TSCA has brought additional requirement to those companies who intend to manufacture or import new chemical substances. During the course of its review, the EPA will consider whether the activities surrounding the manufacture, processing, use, and disposal of the substances identified in the PMN may present an unreasonable risk of injury to human health or the environment. The companies, therefore, should be cautious, and thoroughly review the TSCA and all relevant policies and regulations before their initial manufacturing activities.  Companies are encouraged to try SOCMA’s PMNPro service for assistance in complying with TSCA.  Click here for more information.  Further inquiries with EPA staff may also be directed here





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