Regulatory Actions under TSCA Section 5
Regulatory Actions under TSCA section 5
EPA may take certain regulatory actions under section 5 of TSCA if the Agency determines there is insufficient information to permit a reasoned evaluation of the human health and environmental effects of the chemical or if the chemical presents or may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation.
- “Not likely to present an unreasonable risk” determinations
- TSCA section 5(e) Orders
- Significant New Use Rules (SNURs)
- Is my chemical subject to a SNUR?
- Section 5(f) Actions
TSCA section 5(a)(3)(C) “Not likely to present an unreasonable risk” Determinations
In cases where EPA determines that a new chemical or significant new use is not likely to present an unreasonable risk, EPA will notify the submitter of its decision under TSCA section 5(a)(3)(C) and publish its findings in a statement in the Federal Register pursuant to TSCA section 5(g).
TSCA section 5(e) Orders
- the information in the notice is insufficient to allow the Agency to make a reasoned evaluation of the health and environmental effects of the new chemical substance or the significant new use, or
- in the absence of sufficient information, the manufacture, processing, distribution in commerce, use or disposal of the chemical may present an unreasonable risk to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant to the Administrator under the conditions of use, or
- the chemical substance is or will be produced in substantial quantities and will either enter the environment in substantial quantities or there may be significant or substantial human exposure to the substance.
In such cases, EPA may develop a Consent Order under TSCA section 5(e). A Consent Order typically contains some or all of the following requirements as conditions:
- Testing for toxicity or environmental fate once a certain production volume or time period is reached
- Use of worker personal protective equipment
- New Chemical Exposure Limits (NCELs) for worker protection
- Hazard communication language
- Distribution and use restrictions
- Restrictions on releases to water, air and/or land, and
- Recordkeeping.
Significant New Use Rules (SNURs)
SNURs for Existing Chemicals (i.e., SNURs not promulgated as a result of TSCA New Chemicals Program review)
TSCA Section 5(a) Significant New Use Rules (SNURs) can be used to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns.
Under section 5(a) EPA can determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2):
- Projected volume of manufacturing and processing of a chemical substance.
- Extent to which a use changes the type or form of exposure of humans or the environment to a chemical substance.
- Extent to which a use increases the magnitude and duration of exposure of humans or the environment to a chemical substance.
- Reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import), or process the chemical substance for that use. The notification required by SNURs, known as a Significant New Use Notification (SNUN), allows EPA the opportunity to review the new use and, if necessary, prevent or limit potentially adverse exposure to, or effects from, the new use of the substance.
Learn about how to submit a Significant New Use Notice (SNUN).
SNURs for New Chemicals (i.e., SNURs promulgated as a result of TSCA New Chemicals Program review)
EPA often issues SNURs for new chemicals following the Agency's PMN review. EPA sometimes uses the short-hand reference "section 5(e) SNUR" and "non-section 5(e) SNUR" when referring to SNURs promulgated pursuant to TSCA section 5(a) as a result of the TSCA new chemicals program review. These are discussed below. Because there is detailed communication between EPA and pre-manufacture notice (PMN) submitters during the review period leading to the Agency's final regulatory decision, these SNURs are generally issued as "direct final" rules (see 40 CFR 721.50).
SNURs following a PMN review and TSCA section 5(e) Order
TSCA section 5(e) Orders are only binding on the original PMN submitter for that substance. Consequently, after issuing a section 5(e) Order, EPA generally promulgates a SNUR that mimics the Order to bind all other manufacturers and processors to the terms and conditions contained in the Order. The SNUR requires that manufacturers (which includes importers) and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use." These new use designations are typically those activities prohibited by the section 5(e) Order.
Because the TSCA amendments require EPA to make affirmative findings for all PMNs, SNUNs and MCANs, EPA will not “drop” review of a chemical, and it is expected that the Agency will issue more section 5(e) Orders with associated SNURs following PMN review.
Previously, after review of a PMN, the Agency sometimes “dropped” review of a chemical and issued a SNUR in the absence of a Consent Order (or so-called “non-section 5(e) SNUR”) when it determined that use under certain specific conditions and with appropriate precautions as described in the PMN would not pose an unreasonable risk, but that use under other conditions may pose an unreasonable risk. A small subset of PMNs that previously would have been “dropped” from review and for which a “non-section 5(e) SNUR” would have been issued because EPA would have determined that potential uses other than intended use(s) of the chemical substance were significant new uses will now be subject to Orders issued under TSCA section 5(e). These Orders will hold the submitter to the agreed upon terms of the Order, including various restrictions and testing requirements, applicable to other reasonably foreseeable uses of the new chemical substance. EPA expects that many of these Consent Orders will be agreed to without the need for negotiation and that manufacture can commence quickly once the Consent Orders are signed, since the PMN submitters will be held to some of the terms of the PMN as submitted.
Proposed Changes to General Provisions for SNURs
EPA is proposing changes to the existing regulations governing significant new uses of chemical substances under TSCA to update and align these regulations with revisions to the Occupational Safety and Health Administration’s Hazard Communications Standard , the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals and with changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA is also proposing changes to other general significant new use regulations. Based on a request to extend the comment period, EPA reopened the comment period on October 21, 2016. Comments are due by November 21, 2016. Read the proposal.
EPA’s efforts to coordinate its SNUR program with Canada
- EPA and Environment and Climate Change Canada/Health Canada (ECCC/HC) are working together under the Regulatory Cooperation Council (RCC) to conduct a comparison of the new chemicals review programs in both nations, specifically EPA’s SNUR and Canada’s Significant New Activity (SNAc) programs that require notice to the governments before chemical substances and mixtures are used in new ways that might create environmental or health concerns. EPA and Canada convened stakeholders throughout the supply chain and facilitated two roundtable discussions to identify opportunities for regulators and stakeholders to increase regulatory transparency and coordination between the two countries.
- Read the summary report of the SNUR/SNAc RCC roundtable meetings, which identifies ways in which government and industry can work to better educate and inform stakeholders throughout the supply chain on their compliance requirements, and the best practices for meeting those requirements under the SNUR and SNAc programs.
Is My Chemical Subject to a SNUR?
To facilitate determining whether a substance is subject to a SNUR, substances on the TSCA Inventory that are subject to SNUR requirements are designated as such by an "S" flag in the Inventory listing. If your chemical substance is subject to a SNUR and your intended manufacture, processing, or use of the substance is a significant new use, you would be required to submit a SNUN 90 days prior to the manufacture of that substance.
Several steps should be followed to ascertain the TSCA Inventory/SNUR status of a chemical substance. Information on non-confidential chemical substances can be found in the TSCA Chemical Substance Inventory. Because the chemical identities of the chemical substances can be claimed to be Confidential Business Information (CBI) by the submitters of PMNs, EPA maintains a CBI version of the TSCA Inventory. If an intended manufacturer submits a PMN or a Notice of Bona Fide Intent to Manufacture (pursuant to the procedures at 40 CFR Section 720.25 or 721.11) on a substance that has a listing on the Confidential Inventory, the Agency will notify the submitter of the existence of the SNUR.
It is always the obligation of the manufacturer or processor selling a chemical substance to notify the user of the SNUR status of that substance. Buyers of a chemical substance whose identity is confidential, and thus not disclosed to them, should seek certification from the sellers that their intended use is not a significant new use.
TSCA section 5(f) Actions
If EPA determines that a new chemical or significant new use presents unreasonable risk of injury to health or the environment without consideration of cost or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation under the conditions of use, EPA may (1) limit the amount manufactured/processed/distributed in commerce or impose other restrictions on the substance via an immediately effective proposed rule under section 6 of TSCA, or (2) issue an order to prohibit or limit the manufacture, processing or distribution in commerce to take effect on the expiration of the applicable review period.