EPA has proposed long-awaited amendments to the Toxic Substances Control Act (TSCA) review of new chemicals to codify practices in keeping with the 2016 TSCA amendments. In order to improve efficiencies, industry would be required to provide additional data when submitting new chemicals for review. EPA hopes this will eliminate the need to redo risk assessments which could reduce the chemical review time. The proposal also amends the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs) and removes eligibility for these exemptions for new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic (PBT) substances.
- On June 22, 2016, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” was signed into law, amending the 1976 Toxics Substances Control Act ( 15 U.S.C. § 2601 et seq., 2016). TSCA requires EPA to make affirmative determination on whether a new chemical presents an unreasonable risk to human health or the environment under known, intended, or reasonably seen conditions of use for every new chemical substance.
- TSCA Section 5 (amended in December 2019) governs chemicals that are not listed on the TSCA Inventory. Those substances listed on the Inventory are considered “existing chemicals.” Any chemical not listed is considered a “new chemical substance.” Entities planning on manufacturing or importing a new chemical must submit a pre-manufacture notice to EPA before any activity is initiated.
- A pre-manufacture notice or PMN must be submitted to EPA at least 90 days prior to manufacturing the chemical. Notices are submitted using EPA’s e-PMN software via the Central Data Exchange (CDX) where submitters can submit the application and supporting documentation.
- The PMN must include the following information which is considered by risk assessors:
- Chemical identity
- Structure and formula
- Process diagram and description
- Production volume
- Byproducts and impurities
- Intended use
- Environmental releases
- Disposal practices
- Human exposure
- Existing available test data on the effect on human health and/or the environment
- If EPA determines that the substance “presents an unreasonable risk,” action to protect against such risk must be taken, including prohibiting, or limiting its manufacture. (15 U.S.C. §§ 2604 (f))
- EPA must also regulate the chemical if it lacks information to make a reasoned evaluation, as the lack of information may determine that the chemical may present an unreasonable risk. In addition, EPA may regulate a chemical if the quantities of manufacture or exposure to the substance reach the TSCA section 5(e) exposure based criteria which includes parameters for production volume, worker exposure, and environmental releases
- A significant new use notification (SNUN) is required for chemicals on the inventory proposed to be used in a significantly new way. These are subject to the TSCA section 5(a) Significant New Use Rule (SNUR) which requires an entity to submit a SNUN to EPA at least 90 days before the manufacture, import, or processing of the chemical substance for the new use, using the standard e-PMN form.
- TSCA section 5 provides an exemption from PMN requirements if the use and disposal of the chemical will not present an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation.
- EPA has limited or no reporting requirements for new chemical substances in the following exemptions: Low Volume Exemption, Research and Development Exemption, Low Releases and Low Exposures (LoREX) Exemption, Test Marketing Exemption, and the Polymer Exemption
- Certain categories of low volume chemicals are exempt from full premanufacture notice review under section 5 of TSCA. EPA developed the LVE and LoREX regulations in 1995 pursuant to TSCA section 5(h)(4). The low volume exemption (LVE) is for chemicals manufactured at 10,000 kg/year or less. LVEs undergo a 30-day review.
- Low release low exposure exemptions (LoREX) are those chemicals with low environmental releases and human exposures. The exemption is intended to encourage their development regardless of production volume. For LoREX, the submitter must show there is low or no exposure to the general public in the proposed manufacturing, processing, or uses of the substance. Moreover, any worker exposure must be adequately controlled through engineering controls, work practices, and/or use of personal protective equipment.
- The LoREX limit for ambient surface water releases is 1 part per billion (ppb) using the prescribed calculation. The exposure in drinking water for the general population must be no greater than 1 milligram per year (estimated average dosage resulting from drinking water exposures in streams from the maximum allowable concentration level from ambient surface water releases (1 ppb) or a higher concentration if authorized by EPA.) Ambient air releases from incineration must not exceed 1 microgram per cubic meter maximum annual average calculation. No releases to groundwater are permitted unless the manufacturer has demonstrated negligible groundwater migration.
- However, chemicals cannot be manufactured under this exemption if EPA determines that the substance, any reasonably anticipated metabolites, impurities, environmental transformation products, or byproducts of the substance, may cause, under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance: serious acute (lethal or sublethal) effects, serious chronic (including carcinogenic and teratogenic) effects and/or significant environmental effects. (40 C.F.R. § 723.50(d))
- 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.
- A chemical byproduct that is not used for a commercial purpose is not required to be listed on the TSCA Inventory and does not require a PMN. Also excluded from PMN reporting is any byproduct if its only commercial purpose is for use by public or private organizations that 1) burn it as a fuel, (2) dispose of it as a waste, including in a landfill or for enriching soil, or (3) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.) (40 C.F.R. § 720.30(g), (h)(2))
Amendments to conform regulations to 2016 Lautenberg amendments
- Once the 2016 Lautenberg amendments became effective, EPA began implementing the statutory requirements, however the procedures for reviewing and making determinations on new chemicals were never codified into the new chemicals procedural regulations. The existing text provides “in the absence of regulatory action by EPA under TSCA section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or import the chemical substance even if the submitter has not received notice of expiration [of the review period].” A similar provision is in place for microbial commercial activity notices (MCANs).
- Therefore, EPA is proposing changes to the premanufacture notice (PMN), significant new use notices ( SNUN), and the MCAN procedural regulations to align them with the notice review and determination requirements in TSCA section 5, as amended by the 2016 Lautenberg amendments.
- The proposal would require EPA to make and list one of the five possible determinations on each PMN, SNUN, and MCAN before the submitter could begin manufacturing, importing, or processing the chemical substance. EPA would then provide the action(s) required for the determination.
- EPA is also proposing to add definitions for new terms and to update existing terminology introduced by the 2016 Lautenberg amendments.
- Regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs) are also proposed to be amended by requiring submitters to wait until EPA has issued a decision for the exemption notice before commencing manufacture. EPA is also planning to notify holders of an LVE or LoREX when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) under TSCA and the chemical identity is confidential.
- EPA is proposing that per- and polyfluoroalkyl substances (PFAS) would be categorically ineligible for an LVE or LoREX which would ensure that all submissions of PFAS would be reviewed fully under the PMN process.
- As for substances that are persistent, bioaccumulative and toxic (PBTs), EPA is proposing to codify the 1999 PBT policy, which would make certain PBTs ineligible for an LVE or LoREX.
- Finally, since EPA received numerous request for 15-day suspensions, it is proposing to allow oral or email informal requests for review period suspensions of up to 30 days thereby reducing the number of requests for 15-day suspensions.
EPA announcement of submitted PMNs
- In order to be transparent to the public, EPA has been announcing the receipt of submitted PMNs by publishing a notice in the Federal Register with relevant information on their submission and review.
- EPA has created ChemView, which is an online searchable database of PMNs submitted within five business days from receipt by the submitter. Test data that has been submitted is also available for review (subject to confidentiality claims). This approach was adopted several years ago to provide an alternative to searching individual Federal Register notices and dockets. Stakeholders may review this tutorial on ChemView.
- In order to increase transparency and make information on new chemicals easier to find, EPA has also made available the list of new chemical submissions received on an EPA website. The site provides a general overview of EPA’s new chemicals workload, tracks the current status of active cases currently under review by EPA, and illustrates general statistics for all new chemical submissions received since TSCA was amended on June 22, 2016. The page was last updated on May 2, 2023.
Improving efficiency and accuracy of PMN submissions
- When EPA receives applications that may not contain enough information, the agency makes predictions concerning physical and chemical properties, environmental transport and partitioning, environmental fate, environmental toxicity, human health, engineering releases to the environment, and environmental concentrations by using models. EPA has published a document for submitters, “ Points to Consider When Preparing TSCA New Chemical Notification.”
- However, after providing submitters with conclusions concerning the risk level and mitigation of the applicant substances, the submitter usually will come back with additional information and amend their notice. At this point, the EPA reviewer must begin the review process from the start. EPA has named this situation “rework” and it causes significant delays in making a determination on a PMN. EPA held a webinar in July 2022 explaining why there were significant delays, and this was one of the primary causes. See this AgencyIQ article summarizing the meeting.
- Submitters complete PMN applications on EPA’s Central Data Exchange (CDX), which is the user interface used to collect information for all types of PMNs (SNUNs, LVEs, LoREXs, and test marketing exemption (TME) applications). EPA has published a user guide for CDX to assist submitters with applications.
- Although EPA is not adding new regulatory requirements to the application on the CDX, it is adding new data fields to the application on the user interface. These data fields will request specific detailed information in the hopes that this additional detail will help avoid rework. EPA is proposing to add these details as separate, unique information requirements in 40 CFR 720.45. If a submitter does not know all of the required information, such as details about manufacturing, processing, or use sites out of the submitter’s control, EPA will make conservative assumptions and use conservative default values for this information.
- EPA will be amending certain sections of TSCA to reflect the detailed data requirements that will be added to the PMN application form, including those concerning physical and chemical properties. For instance, EPA is proposing to require that data on surface tension and ultraviolet–visible (UV-VIS) absorption, as well as any particle size distribution analysis, be submitted as part of the PMN form, to the extent it is known to, or reasonably ascertainable by, the submitter (40 CFR 720.45(j)(1)). EPA explains that its ability to assess risk would improve if the value were accompanied by the analysis data used to develop the value.
- Similarly, since information requirements for nanomaterial morphology are not currently on the CDX user interface pick list for physical and chemical properties, EPA is proposing to require information for aspect ratio, thickness, and number of layers or walls for nanomaterials at 40 CFR 720.45(j)(1). EPA is also proposing additional information requirements for environmental fate characteristics of chemical substances, among others.
- EPA is also proposing to add additional detail on the categories of use of the chemical substance and request specific information on commercial and consumer uses, such as types of products or articles that would incorporate the new chemical substance (e.g., household cleaners, plastic articles), how and where a product or article incorporating the new chemical substance would be used (e.g., spray applied indoors, brushed on outdoor surfaces), and consumption rates, among others.
- Of note is EPA’s proposal to add a requirement to designate applicable consumer and commercial product categories using Organisation for Economic Co-operation and Development (OECD)-based functional use codes, which would create consistency with TSCA section 8(a) Chemical Data Reporting (CDR) requirements. These would also be added to the PMN form fields in CDX.
- EPA is proposing to add information to the PMN form related to each site where the chemical substance will be manufactured, processed, or used for both sites controlled by submitters and sites controlled by others, since EPA finds this information is typically not well characterized by submitters. Although these details are already covered by the existing information requirements in 40 CFR 720.45(g)(2) and (h) for a process description of operations at such sites, EPA is proposing to add them as separate, unique information requirements and in new fields in the PMN form to clarify the level of detail needed and to ensure that the regulations and PMN form are consistent. For submitter-controlled sites, EPA is also proposing to add requirements for whether a particular chemical substance is manufactured or processed via batch or continuous production, as well as the amount of the chemical substance manufactured or processed in a given batch and/or timeframe, among other proposed details.
- Worker exposure is another area which is covered in the PMN form, however EPA is proposing to add separate, unique required information fields in the form about the possible types of worker exposure at each site, the descriptions of any protective equipment and engineering controls in place, the moisture content of the chemical substance (if a solid), and the percentage of the chemical substance in the formulation at the time of exposure, worker activities and descriptions of the physical form of the chemical substance.
- Finally, although the details on environmental releases are covered by the existing information requirements in 40 CFR 720.45( (g)(4)) and (h), and some already have a corresponding field in the PMN form in CDX, EPA is proposing to add them as separate, unique information requirements and in new fields in the PMN form to clarify the level of detail needed and to ensure that the regulations and PMN form are consistent.
- EPA is also proposing to allow informal requests for review period suspensions of up to 30 days. The current 15-day suspensions are repeatedly requested, and the new 30-day request could be made orally or by email, which would save time and effort on both sides.
- The PMN Form in CDX will be amended to require submitters leaving any fields blank to check a box confirming that the information is not known by the submitter before they may move on to the next field. Additionally, a statement would warn the submitter of potential consequences of leaving the field blank and then later amending the field.
- EPA estimates that these proposed amendments would have “a very minor impact on submitter burden” since they are already included in the fields that submitters must complete in the PMN form in the CDX.
Changes to PMN exemptions – LVE and LoREX for PBTs and PFAS
- For chemicals manufactured under the byproduct or impurity exemptions, EPA is proposing clarifying amendments to ensure that submitters include worker exposure and environmental release information at each site where the chemical substance will be manufactured, processed, or used, if known or reasonably ascertainable.
- EPA has proposed adding a definition for “PBT chemical substance” as “a chemical substance possessing characteristics of persistence (P) in the environment, accumulation in biological organisms (bioaccumulation (B)), and toxicity (T) resulting in potential risks to humans and ecosystems.”. Due to these characteristics EPA is proposing for PBTs to be disqualified from the LVE and LoREX exemptions since it is inherent in these 1995 exemptions that the manufacture, processing, distribution in commerce, use, or disposal of the substance will not present an unreasonable risk of injury to health or the environment. Currently, these exemption regulations do not expressly disqualify PBT chemical substances from eligibility for the LVE or LoREX. Submitters could still apply for an exemption notice for a given substance, however, the finding that a substance is PBT would be made by EPA during the review of the notice. EPA would review the submission of a substance based on the available data and make a determination on a case-by-case basis. As such, a submitter may not be able to determine in advance of submitting an exemption notice if EPA would find the substance to be PBT.
- EPA is also proposing to make these two exemptions unavailable for PFAS which would ensure that all new PFAS are reviewed through the full PMN process. For the purpose of making PFAS ineligible for LVEs and LoREXs, EPA is proposing to define “PFAS” as one of three structures as defined in the January 2023 Inactive PFAS SNUR. Manufacturers of substances that do not meet this structural definition would remain eligible to submit an LVE or LoREX notice.
- Prior to April 2021, EPA had approved more than 600 LVE notices for PFAS. EPA also encouraged voluntary withdrawal of these LVEs and, as of April 2023, 45 PFAS LVEs have been voluntarily withdrawn. Since May 2020, EPA has not received or approved any PFAS LoREX notices. Under the proposal, any LVE or LoREX notice for a PFAS that is submitted to the agency would be denied upon receipt without substantive review. By reviewing all new PFAS as PMNs, EPA will have the authority to address information gaps when there is insufficient information on the chemical substance and to further support the agency’s PFAS Strategic Roadmap. See this AgencyIQ article for additional information.
- This action, if finalized, is expected to reduce rework of risk assessments by minimizing requests from submitters to amend their PMNs, SNUNs, MCANs, or exemption notices with additional information after the review period has commenced.
- The rule would also change the LVE and LoREX exemptions currently in place for PFAS and PBTs
- According to EPA, the changes presented in this proposed rule are expected to decrease the total annual burden to industry by approximately 4,518 hours, while total annual costs to industry submitters are expected to have a net increase of $45,120. The Agency is expected to experience an annual cost savings of approximately $923,280.
- Once published in the Federal Register, comments will be accepted for 60 days to Docket No. EPA-HQ-OPPT-2022-0902 at https://www.regulations.gov.
Key documents and dates
- Proposed Rule: Updates to New Chemicals Regulations under the Toxic Substances (pre-publication version)
- TSCA New Chemical Engineering Outreach Initiative to Increase Transparency and Reduce Rework: Analysis of New Chemicals Rework Issues
- Analysis of Engineering Information Submitted for TSCA Section 5 New Chemicals Submissions
- Basic Information for the Review of New Chemicals
- TSCA section 5 Low Volume Exemption
- Toxics Substances Control Act