Regulatory Actions under TSCA section 5
Recent Activities for the New Chemicals Program
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).
- View EPA PMN review determinations under amended TSCA
TSCA section 5(e) Orders
One outcome of EPA's review of a PMNfor a new chemical substance is the issuance of an order pending development of information under section 5(e) of TSCA. Most TSCA section 5(e) Orders issued by EPA are Consent Orders that are negotiated with the submitter of the PMN. When reviewing a PMN for a new chemical substance, the Agency can determine that:
- 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 Orderunder 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
Consent Orders generally follow therelatively standard format used in the"boilerplate".
Consent Orders with NCELs provisions will include the NCELs section Order insert.
A company subject to a TSCA section 5(e) Order that requires testing to be conducted must notify, in writing, the EPA Monitoring Assistance and Media Programs Division (2227A), Office of Enforcement and Compliance Assurance (OECA), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington D.C. 20460, of certain study-related information within 10 days of scheduling any study required to be performed pursuant to the Order.
- View Consent Orders in ChemView by checking the Consent Order box under EPA Actions in the Show Output Selection area of ChemView.
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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).
SNURsfollowing 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 SNURthat 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.
Viewall SNURs in ChemView by checking the SNUR box under EPA Actions in the Show Output Selection area of ChemView.
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.
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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 720.25or 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.
Access the TSCA Chemical Substance Inventory and learn about submitting a Notice of Bona Fide Intent to Manufacture.
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.
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TSCA section 5(f) Actions
If EPA determines that a new chemicalor significant new use presents unreasonable riskof 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.
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What is TSCA Section 5 requirements? ›
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.What is Section 5 of the Toxic Substances Control Act TSCA? ›
Section 5(a)(2) of the Toxic Substances Control Act (TSCA) authorizes EPA to determine that a use of a chemical substance is a "significant new use." After considering all relevant factors, including those listed in TSCA section 5(a)(2), EPA makes this determination by promulgating Significant New Use Rules (SNURs).What is regulated under TSCA? ›
Toxic substances subject to TSCA regulation include PCBs, asbestos, lead, mercury, formaldehyde, and certain hexavalent chromium compounds. Operations at Federal facilities typically involve management of toxic substances regulated under TSCA.What are the three main objectives of the TSCA? ›
Its three main objectives are to assess and regulate new commercial chemicals before they enter the market, to regulate chemicals already existing in 1976 that posed an "unreasonable risk to health or to the environment", as for example PCB's, lead, mercury and radon, and to regulate these chemicals' distribution and ...What must be reported under TSCA? ›
Overview. Section 8(e) of the Toxic Substances Control Act (TSCA) requires that EPA be immediately notified when substances or mixtures present a substantial risk of injury to health or the environment.What is TSCA Section 5 B )( 4? ›
Section 5(b)(4) of the Toxic Substances Control Act authorizes the Administrator to compile and keep current a list of chemical substances with respect to which the Administrator finds that the manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may ...How do I comply with TSCA? ›
To be TSCA Title VI compliant, wood products must undergo testing, certification, and labelling. Companies processing or otherwise using wood products should be aware of whether they are purchasing TSCA-compliant materials.How much per day can EPA fine companies who do not comply with TSCA? ›
Penalty: 1 year and/or up to $50,000 per day violation.Which regulations cover hazardous substances? ›
COSHH is the law that requires employers to control substances that are hazardous to health and includes nanomaterials. You can prevent or reduce workers' exposure to hazardous substances by: finding out what the health hazards are; deciding how to prevent harm to health (risk assessment);What are exemptions under TSCA? ›
(1) Any chemical substance is exempted from many of the requirements of TSCA when it is: - imported, produced or used in small quantities, and - solely for purposes of non-commercial scientific experimentation, analysis or research, and - under the supervision of a technically qualified individual.
How many chemicals are on the TSCA list? ›
It can be searched in multiple ways. This page provides ways to download the non-confidential Inventory and offers help in using these downloaded files. The February 2023 update is available below. The Inventory contains 86,685 chemicals of which 42,170 are active.What is a regulated substance? ›
Regulated Substance means any substance, material or waste the use, generation, handling, storage, treatment or disposal of which is regulated by any local or state government authority, including any of the same designated by any authority as hazardous, genetic, cloning, fetal, or embryonic.What are 4 things the EPA does to oversee regulatory programs? ›
It oversees programs to promote energy efficiency, environmental stewardship, sustainable growth, air and water quality, and pollution prevention.What are 3 major successful policies that came from the EPA? ›
From regulating auto emissions to banning the use of DDT; from cleaning up toxic waste to protecting the ozone layer; from increasing recycling to revitalizing inner-city brownfields, EPA's achievements have resulted in cleaner air, purer water, and better protected land.What is a major weakness of the TSCA? ›
The lack of toxicity data is just one of the problems with the old TSCA. Even when the EPA had lots of toxicity data, it was incredibly difficult for it to ban a chemical.What is TSCA reporting? ›
The Chemical Data Reporting (CDR) rule, under the Toxic Substances Control Act (TSCA), requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce.Who is responsible for TSCA? ›
As the importer of a chemical or material, responsibility for TSCA compliance rests almost entirely with you and your research group. Your laboratory or research group are responsible for determining if TSCA applies to your laboratory activities.What does it mean if a chemical is on the TSCA list? ›
The Toxic Substances Control Act (TSCA) Chemical Substance Inventory contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. This may be your starting place for interaction with EPA on TSCA regulatory matters.What are the final significant new use rules in TSCA 5 a 2? ›
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: The projected volume of manufacturing and processing of a chemical substance.
Section 6(a) of the Toxic Substances Control Act (TSCA) provides authority for EPA to ban or restrict the manufacture (including import), processing, distribution in commerce, and use of chemical substances, as well as any manner or method of disposal.
What is an example TSCA statement? ›
I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder. I certify that all chemicals in this shipment are not subject to TSCA.Under what regulation would you store a hazardous substance? ›
Under the Control of Substances Hazardous to Health Regulations (COSHH) you must store and handle chemicals and dangerous substances in a way that: minimises the risks. limits people's exposure to them.How are hazardous materials regulated? ›
Hazardous materials are defined and regulated by the U.S. Environmental Protection Agency (EPA), U.S. Occupational Safety and Health Administration (OSHA), U.S. Department of Transportation (DOT), and U.S. Nuclear Regulatory Commission (NRC).How many chemicals are registered for use in the US? ›
EPA has more than 85,000 chemicals listed on its inventory of substances that fall under the Toxic Substances Control Act (TSCA).What if a chemical is not on TSCA list? ›
The TSCA Inventory is a list of more than 80,000 chemicals in commercial production and use in the United States. If a chemical is not on it, a company generally must file a premanufacture notice (PMN) with EPA 90 days prior to commercial production.How many chemicals has TSCA banned? ›
Over 60,000 existing chemicals have been tested since the passage of TSCA and some harmful chemicals, like asbestos, have been banned under Section 6.What are the 5 types of controlled substances? ›
Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Controlled substances with known medical use, such as morphine, Valium, and Ritalin, are available only by prescription from a licensed medical professional.What is an example of regulated substance? ›
Regulated Substances means pollutants, contaminants, hazardous or toxic substances, compounds or related materials or chemicals, hazardous materials, hazardous waste, flammable explosives, radon, radioactive materials, asbestos, urea formaldehyde foam insulation, polychlorinated biphenyls, petroleum and petroleum ...What are the four essential components of a regulatory system? ›
These core regulatory components—regulator, target, command, and consequences—affect the incentives and flexibility that a regulation provides.What are 4 examples of EPA regulations? ›
- Atomic Energy Act (AEA)
- Beaches Environmental Assessment and Coastal Health (BEACH) Act.
- Chemical Safety Information, Site Security and Fuels Regulatory Relief Act.
- Clean Air Act (CAA)
What are 5 functions of the Environmental Protection Agency EPA )? ›
- National Environmental Enforcement.
- Waste Management and Chemicals in the Environment.
- Water Management.
- Climate Science & Climate Change.
- Environmental Monitoring & Assessment.
- Environmental Research and Development.
- Radiological Protection.
Toxic Substances And Hazardous Waste Management Act (RA 6969) Clean Air Act Of 1999 (RA 8749) Ecological Solid Waste Management Act (RA 9003) Clean Water Act (RA 9275)How does the EPA enforce their regulation and laws? ›
An administrative action by EPA or a state agency may be in the form of: a notice of violation or a Superfund notice letter, or. an order (either with or without penalties) directing an individual, a business, or other entity to take action to come into compliance, or to clean up a site.What are the most important laws governing the EPA? ›
Some of the better-known laws related to the environment are the Clean Air Act, the Clean Water Act, and the Safe Drinking Water Act.Does TSCA follow precautionary principle? ›
While the policy statement in TSCA is a variant on the pre-cautionary principle, the operative portions of the law require a presumption of safety if risk data is absent, which is a rejection of the precautionary principle.Is the TSCA effective? ›
The Toxic Substances Control Act of 1976 governed chemicals in commerce in the United States, but it is widely known to be weak and ineffective and did not require manufacturers to test or provide data about the health impact of chemicals before they accessed the lucrative U.S. market.What is Section 5 A )( 2 of TSCA? ›
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: The projected volume of manufacturing and processing of a chemical substance.Who is exempt from TSCA? ›
(1) Any chemical substance is exempted from many of the requirements of TSCA when it is: - imported, produced or used in small quantities, and - solely for purposes of non-commercial scientific experimentation, analysis or research, and - under the supervision of a technically qualified individual.How does TSCA regulate existing chemicals? ›
For chemicals new to U.S. commerce, TSCA requires pre-market screening and regulatory tracking of new chemical products. If EPA identifies unreasonable risks associated with existing or new chemicals, TSCA requires the agency to initiate rulemaking to reduce risks to a reasonable level.What is TSCA Section 4? ›
Section 4 of the Toxic Substances Control Act (TSCA) allows EPA to require chemical manufacturers (including importers) and processors to develop information on chemicals and submit such information to EPA.
What do TSCA sections 8c regulate? ›
This rule imple- ments section 8(c) of TSCA. It describes the records to be kept and prescribes the conditions under which certain firms must submit or make the records available to a duly designated representa- tive of the Administrator.What is Section 13 of TSCA? ›
TSCA Section 13 requires that any chemical substance, mixture, or article containing a chemical substance or mixture be refused entry into the customs territory of the United States if it fails to comply with any rule in effect under TSCA or is offered for entry in violation of section 5, 6, or 7 of TSCA.Who regulates chemicals in products? ›
EPA regulates the production and distribution of commercial and industrial chemicals, in order to ensure that chemicals for sale and use in the United States do not harm human health or the environment. Read more at Pollution Prevention and Toxics.Who fills out the TSCA form? ›
Import Certification Form Instructions
The Principal Investigator, Lab Manager or Researcher must fill out the TSCA Import Certification Form which will accompany the purchase order that lists the chemical names. This form must be available to the carrier and customs officer at the time of import.