The Toxic Substances Control Act Frequently Asked Questions
What is a chemical substance for purposes of regulation under TSCA?
The Toxic Substances Control Act (TSCA) defines the term “chemical substance” as “any organic or inorganic substance of a particular molecular identity, including — (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and (ii) any element or uncombined radical.” The U.S. Environmental Protection Agency (EPA) states: “TSCA defines ‘chemical substance’ broadly and in terms that cover intergeneric microorganisms as well as traditional chemical substances.”
Are there any exemptions from the definition of a “chemical substance”?
TSCA specifically exempts from the definition of “chemical substance” (1) mixtures (although mixtures of chemical substances can be regulated under certain provisions of TSCA and chemical substance components of mixtures are themselves covered under TSCA provisions that apply to “chemical substance”); (2) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticides; (3) tobacco and tobacco products; (4) certain materials regulated under the Atomic Energy Act; (5) firearms and ammunition; and (6) foods, food additives, drugs, cosmetics, and devices regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition to those things specifically excluded from TSCA as a “chemical substance,” EPA has exempted other categories of substances from certain TSCA requirements. For example, certain chemical substances — including impurities and certain byproducts — are excluded from TSCA Section 5 requirements because “[a]lthough they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part.” EPA also exempts chemical substances when parts of articles from various TSCA requirements.
What are “articles” under TSCA?
Certain TSCA regulations define “article” as “a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles.” Fluids and particles are not considered articles, however, regardless of shape or design. Chemical substances that are part of articles and that are not intended to be removed and have no separate commercial purpose are generally exempt from certain TSCA regulations (e.g., TSCA premanufacture notification (PMN)). Chemical substances contained in articles that are designed to be used separately from the article or released (i.e., ink in pens) are not considered to be part of an article for the purposes of an article exemption where applicable.
Of note, while persons that import or process chemical substances as parts of articles are exempt under certain TSCA requirements (e.g., TSCA Section 5 PMN requirements and, generally, significant new use notification (SNUN) requirements), EPA increasingly has been covering these persons in actions under TSCA and regulating the manufacture (including import), processing, and distribution in commerce of chemical substances as part of articles in TSCA regulations.
Who is subject to TSCA requirements?
Depending on the particular provision, TSCA may apply to any person who manufactures (including imports),processes, distributes in commerce, uses commercially, or disposes of a chemical substance, including as part of mixtures and articles.
How does EPA keep track of the chemical substances manufactured or processed in the United States?
TSCA Section 8(b) directs EPA to “compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States.” This list is known as the TSCA Chemical Substance Inventory (TSCA Inventory). EPA compiled the initial TSCA Inventory in 1977. The TSCA Inventory is continually updated by the addition of chemical substances for which a PMN and subsequent notice of commencement (NOC) have been submitted. For those chemical substances whose identities are confidential, EPA maintains a confidential portion of the TSCA Inventory that only EPA can review.
How can a person search the confidential portion of the TSCA Inventory?
A manufacturer or importer can request that EPA search the TSCA Confidential Inventory by filing a bona fide intent request (BFI Request). A BFI Request is a letter submitted to EPA by a manufacturer or importer asking EPA to search the TSCA Confidential Inventory. A manufacturer or importer may submit a BFI Request only if it meets the requirements established by EPA at 40 C.F.R. Section 720.25.
What chemical substances are subject to PMN requirements?
Chemical substances manufactured in or imported into the United States that are not listed on the TSCA Inventory and that are not otherwise exempt from TSCA Inventory listing are considered “new” chemical substances subject to TSCA Section 5 PMN requirements.
What are the exemptions from PMN requirements?
Some chemical substances that are not listed on the TSCA Inventory may be exempt from PMN and related TSCA Section 5 requirements. Several exemptions from PMN requirements are considered “self-executing” because they do not require EPA approval. Instead, once a manufacturer or importer determines that one of the self-executing exemptions applies, the new chemical substance may be manufactured or imported without first submitting a PMN, so long as the company complies with any recordkeeping or other requirements for the particular exemption. The self-executing exemptions are exemptions for chemical substances having no “separate commercial purpose”; polymers meeting specified requirements; substances imported as part of articles; and research and development (R&D) substances meeting specified requirements. Certain other exemptions from PMN requirements require EPA approval. In these instances, a manufacturer or importer must submit, and EPA must approve, an exemption application before a company may authorize the manufacture or import of the new chemical substance. In addition, each manufacturer or importer must comply with any recordkeeping or other requirements for the particular exemption approved by EPA. Among these exemptions are: low volume exemptions (LVE); low release and exposure exemptions (LoREX); and test marketing exemptions (TME).
What information does EPA require in a PMN?
The PMN regulations at 40 C.F.R. Part 720 require information on the submitter’s identity, the chemical substance’s identity, production volume, uses, exposures, and environmental fate. TSCA does not require a submitter to test new chemical substances before submitting a PMN. Health and safety data relating to a new chemical substance’s health or environmental effects that are in a submitter’s possession or control, however, must be submitted with the PMN. The submitter must provide this information to “the extent it is known to or reasonably ascertainable by the submitter.” EPA has developed a PMN review process to estimate the risk attributable to a new chemical substance and to determine whether an unreasonable risk of injury to health or the environment may occur if the chemical substance is distributed in commerce. EPA may request additional information from a submitter during its review of a PMN application.
When must a NOC be submitted?
Within 30 days of the first commercial manufacture (date of completion of production lot) or import (date new chemical substance clears U.S. Customs) of a chemical substance for which EPA has approved a PMN, the manufacturer or importer must prepare a draft NOC using EPA’s Form 7710-56. The NOC seeks information on the submitter’s identity, the chemical substance’s identity, and the date of commencement of manufacture or import. Upon receipt of the NOC, EPA places the PMN chemical substance on the TSCA Inventory.
Can EPA require persons to test chemical substances subject to TSCA?
Yes. Section 4 of TSCA gives EPA the authority to require chemical manufacturers, importers, and/or processors to test chemicals and report the results to EPA. Under Section 4, EPA can by rule require testing after making “data inadequacy” and “testing is necessary” findings. Testing required by EPA must be conducted via EPA-approved test methods and guidelines. Additionally, TSCA Section 4 gives EPA the authority to issue test orders to require chemical manufacturers, importers, and/or processors to test chemicals and report the results to EPA. Finally, EPA has authority to enter into Enforceable Consent Agreements to develop needed information.
When can EPA issue an administrative order controlling new chemical substances?
TSCA Section 5(e) grants EPA the authority to issue administrative orders controlling new chemical substances and significant new uses pending the development of information, where it finds (1) there is insufficient information to evaluate the risk reasonably, and (2) in the absence of sufficient information, either (i) 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 (ii) the chemical substance is or will be produced in substantial quantities and enters or may be expected to enter the environment in substantial quantities or there is or may be substantial or significant human exposure. In its order, EPA can ban or limit the manufacture, processing, distribution, use, or disposal of the chemical.
Under TSCA Section 5(f), 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 non-risk 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.
What is a significant new use for a chemical substance?
Section 5(a) requires manufacturers, importers, and processors of existing chemicals to provide notice to EPA of any use of a substance that EPA has determined is “a significant new use.” A determination that a use is significant and new must be made by rule, known as a Significant New Use Rule (SNUR). TSCA does not establish standards or criteria for establishing when a new use is deemed “significant,” but requires EPA to consider “all relevant factors” before promulgating a SNUR, including (1) the projected volume of manufacturing and processing of a chemical substance, (2) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, (3) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and (4) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
Can EPA seize a chemical substance if EPA determines it presents an unreasonable risk to human health or the environment?
Yes. EPA may commence a civil action in an appropriate United States district court to seize chemical substances or mixtures that EPA determines are imminently hazardous chemical substances or mixtures that will present an unreasonable risk of serious and widespread injury to health and the environment.
What is the TSCA Chemical Data Reporting rule?
The TSCA Chemical Data Reporting (CDR) rule (40 C.F.R. Part 711) requires manufacturers and importers to provide EPA with information on the production and use of chemicals in commerce. Under the CDR rule, manufacturers and importers are required to report to EPA exposure-related information, including information on the types, quantities, and uses of chemical substances produced domestically and imported into the United States. CDR information is collected every four years from manufacturers and importers of certain chemicals in commerce generally when production volumes for the chemical are 25,000 lbs or greater (2,500 lbs or greater for chemicals covered by certain TSCA actions) for a specific reporting year.
What is a “significant adverse reaction” under the TSCA Section 8(c) regulations for which records must be kept and potentially reported to EPA by chemical manufacturers, importers, and certain processors?
The TSCA Section 8(c) regulations at 40 C.F.R. Part 717 define “significant adverse reactions” as “reactions that may indicate a substantial impairment of normal activities, or long-lasting or irreversible damage to health or the environment.” Examples of “significant adverse reactions” that must be reported are provided at 40 C.F.R. Section 717.12. They include, but are not limited to, long-lasting or irreversible health effects such as cancer and neurological effects; impairment of normal activities experienced by a number of people exposed to the same event or by one person each time he or she is exposed; long-lasting or irreversible damage to biological species, such as fish-kills or reduction in the ability of a species to survive; and long-lasting or irreversible effects on environmental media, such as groundwater contamination.
How must companies record significant adverse reactions?
EPA has not created a specific form to use to record TSCA Section 8(c) allegations. TSCA Section 8(c) allegation records must contain, however, certain information concerning each recordable allegation, including the original allegation as received and an abstract of the allegation and other information, including as follows: (1) the name and address of the site that received the allegation; (2) the date the allegation was received; (3) the implicated substance, mixture, article, company process or operation, or site discharge; (4) a description of the person making the allegation (i.e., employee, customer, plant neighbor), including the gender and birth year of any person alleged to have experienced a health effect, if ascertainable; and (5) a description of the alleged health or environmental effects.
Can EPA require companies to submit to EPA their records of significant adverse reactions?
Yes. EPA may issue a letter or Federal Register notice requiring the submission of TSCA Section 8(c) allegation records to EPA. The Federal Register notice will specify which records or portion of records must be submitted, and whether allegations relating to mixtures must be reported.
What is a “health and safety study” that may be reportable to EPA under TSCA Section 8(d)?
TSCA defines a “health and safety study” as “any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to [TSCA].” Under the TSCA Section 8(d) rule at 40 C.F.R. Part 716, manufacturers (including importers) who fall within the North American Industrial Classification System (NAICS) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries) must submit, for certain chemical substances and mixtures, unpublished health and safety studies that are in their possession, lists of all unpublished health and safety studies on those chemical substances and mixtures known to them but not in their possession, and lists of all unpublished health and safety studies being conducted or initiated on those chemical substances and mixtures. EPA may also require under the regulation manufacturers (including importers) that do not fall within those NAICS codes, as well as processors, to report.
Are there any requirements to report to EPA adverse effects information concerning a chemical substance?
Yes. Pursuant to TSCA Section 8(e), any person who manufactures (including imports), processes, or distributes a chemical substance or mixture and who obtains information which reasonably supports the conclusion that the chemical substance or mixture poses a substantial risk of injury to health or the environment must provide the information to EPA immediately. EPA provides in reporting guidance that “immediately” means “not later than the 30th calendar day after the date the person obtained such information.” Exceptions include information about emergency incidents of environmental contamination, which must be reported immediately, and non-emergency incidents of environmental contamination, which must be reported to EPA within 90 days of obtaining the information unless reported within 90 days to another EPA office or federal or state regulatory agency.
Does EPA provide guidance on what is a “substantial risk of injury” to health or the environment under TSCA Section 8(e)?
EPA has emphasized that “substantial risk” information “need not and most typically does not establish conclusively that a risk exists.” EPA has also stated that in deciding whether information is “substantial risk” information, one must consider “(a) the seriousness of the effect, and (b) the fact or probability of the effect’s occurrence.” According to EPA, the two criteria should be weighed differently depending on the seriousness of the effect or the extent of the exposure (the more serious the effect, the less heavily one should weigh exposure, and vice versa). Further EPA guidance on reporting under TSCA Section 8(e) can be found here.
Are there exemptions from reporting substantial risk information under TSCA Section 8(e)?
Yes. According to guidance issued by EPA, information otherwise potentially subject to the reporting requirements of TSCA Section 8(e) need not be submitted if the information: (1) is contained in an EPA study or report; (2) is published in the open scientific literature or major U.S. news publication; (3) has been reported to EPA under mandatory reporting requirements of TSCA or other authority administered by EPA; (4) is contained in a formal publication, report, or statement made available to the public by another federal agency; (5) is corroborative of a well-established adverse effect (and does not newly identify any serious adverse effects or confirm a previously suspected serious adverse effect); or (6) is information for which EPA has waived compliance in accordance with TSCA Section 22.
Must EPA protect from disclosure certain information submitted to EPA and claimed as confidential?
Yes. TSCA Section 14 broadly defines information that may not be disclosed by EPA (i.e., Confidential Business Information) in the context of the Freedom of Information Act (FOIA, 5 U.S.C. Section 552) exemption 4 (5 U.S.C. Section 552(b)(4)), which allows for “trade secrets and commercial or financial information obtained from a person and privileged or confidential” submitted to EPA to be withheld from public disclosure. TSCA Section 14(b), however, identifies several categories of information that are not protected from disclosure, notwithstanding the FOIA exemption. EPA has issued “Frequent Questions about TSCA CBI” that are available here.
When must exporters notify a country that it intends to export a chemical substance?
Chemical substances and mixtures subject to TSCA Section 12(b) export notification requirements are those for which EPA has taken one or more of the following actions: (1) data have been required under TSCA Section 4 or 5(b); (2) an order has been issued under TSCA Section 5; (3) a rule has been proposed or promulgated under TSCA Section 5 or 6; or (4) an action is pending or relief has been granted under TSCA Section 5 or 7. Regulations implementing TSCA Section 12(b) are at Subpart D of 40 C.F.R. Part 707.
What information must be provided in a TSCA Section 12(b) export notification?
If a TSCA Section 12(b) export notification is required for any chemical substance or mixture, the exporter must prepare a notice to EPA to be sent in writing or electronically. Each notice must include:
(a) The name of the regulated chemical as it appears in the section 4, 5, 6, and/or 7 action. If a category is regulated, the name of the individual regulated chemical within that category, as well as the category, must be given. The name shall be that which appears in Volume I of the EPA Chemical Substance Inventory, or its supplements, if the chemical appears there.
(b) The name and address of the exporter.
(c) The country (countries) of import
(d) The date(s) of export or intended export.
(e) The section (4, 5, 6, and/or 7) of TSCA under which EPA has taken action.
Does TSCA regulate the importation of chemical substance?
Yes. Under TSCA, “manufacture” is defined to include import, so TSCA provisions and regulations thereunder that apply to manufacturers cover domestic producers as well as importers, unless stated otherwise.
Furthermore, under TSCA Section 13, the Secretary of the Treasury must refuse entry into the United States of any shipment containing any chemical substance, mixture, or article if the shipment fails to comply with TSCA. Under rules adopted by the United States Customs and Border Control at 19 C.F.R. Sections 12.118 through 12.127, importers (or their authorized agents) of chemical substances in bulk form, as part of mixtures, and in limited cases as part of articles, must certify in writing to the director of the port of entry or electronically through the Automated Commercial Environment system, for each shipment containing chemical substances in bulk and mixtures, and in limited cases articles, that: (1) all chemical substances in the shipment being imported comply with all applicable rules and orders (includes those under TSCA Sections 5, 6, and 7), and are not offered for entry in violation of TSCA (positive certification); or (2) all chemicals, in the shipment are not subject to TSCA (negative certification).
Does EPA have inspection authority under TSCA?
Yes. TSCA Section 11 grants to EPA broad authority to conduct inspections to enforce the Act. Under TSCA Section 11(a), EPA may inspect any establishment, facility, or other premises in which chemical substances or mixtures are manufactured, processed, stored, or held before or after their distribution in commerce, and any conveyance being used to transport chemical substances in connection with their distribution in commerce. Failure or refusal to permit entry or inspection as required under Section 11 constitutes an unlawful act under TSCA Section 15, giving rise to civil penalties.
What activities are unlawful under TSCA?
Under TSCA Section 15, it is unlawful to:
(1) fail or refuse to comply with any requirement of [TSCA Title I (Control of Toxic Chemicals)] or any rule promulgated, order issued, or consent agreement entered into under [TSCA Title I], or any requirement of [TSCA Title II (Asbestos Hazard Emergency Response)] or any rule promulgated or order issued under [TSCA Title II’;
(2) use for commercial purposes a chemical substance or mixture which such person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of [Section 5 or 6 of TSCA Title I title], a rule or order under [Section 5 or 6 of TSCA Title I], or an order issued in action brought under [Section 5 or 7 of TSCA Title I];
(3) fail or refuse to (A) establish or maintain records, (B) submit reports, notices, or other information, or (C) permit access to or copying of records, as required by [TSCA] or a rule thereunder; or
(4) fail or refuse to permit entry or inspection as required by [Section 11].
Are there criminal liabilities under TSCA?
TSCA Section 16(b) authorizes EPA to seek criminal penalties against any person who “knowingly or willfully” violates any provision of TSCA Section 15. EPA can seek criminal fines of up to $50,000 for each day the violation continues and/or imprisonment for up to one year, or both. EPA can seek criminal penalties in lieu of, or in addition to, civil penalties.
What resources are available to learn more about TSCA?
The TSCA Hotline is an information service sponsored by EPA to answer questions about TSCA regulations and initiatives and requests for TSCA-related Federal Register notices, guidance documents, and other materials pertaining to the TSCA program. The hotline telephone number is (202) 554-1404. It is staffed Monday through Friday from 8:30 a.m. to 5:00 p.m., Eastern Time. A large array of information regarding TSCA can also be found on the Internet at EPA’s website. EPA’s address is http://www.epa.gov.
Bergeson & Campbell, P.C.’s (B&C) TSCA Tutor® online training platform offers expert, essential TSCA training in a modular format that allows companies and individuals to tailor regulatory training to meeting their unique business needs. B&C also publishes the TSCAblog® that provides timely news and analysis regarding TSCA legal and administrative developments.