TSCA Title I Control of Toxic Substances

• Requirements for chemicals regulated under TSCA apply to chemicals manufactured in the U.S. and imported into the U.S.
• TSCA does not allow chemical evaluation and restriction to be delegated to states.
• There are certain noteworthy major sections in Title I of TSCA.

The Toxic Substances Control Act (TSCA) directs the U.S. Environmental Protection Agency (EPA) to evaluate the lifecycle (i.e., manufacture, importation, processing, distribution, use, and disposal) of industrial and commercial chemicals for unreasonable risks and, if warranted, to regulate such chemicals.

TSCA, as amended, requires EPA to gather existing information from chemical manufacturers, processors, and distributors about risks that industrial and commercial chemicals may present to human health or the environment. Prior to introducing a new chemical into commerce, its manufacturer must notify EPA to allow the agency to evaluate the chemical for unreasonable risks. Similar notification requirements apply to existing chemicals proposed for uses determined by EPA to be “significant new uses.”

If EPA has inadequate information about a chemical to determine whether it presents unreasonable risks, the agency may require the manufacturer to develop new information necessary to evaluate risks. TSCA establishes a framework to protect from disclosure submitted information that warrants confidential treatment.

To identify which chemicals may warrant regulation, TSCA requires EPA to systematically prioritize chemicals for risk evaluation. Based on the evaluation, EPA must regulate those chemicals that present unreasonable risks to ensure they no longer do so. Regulatory options available to EPA range from labeling requirements to an outright ban on manufacturing. TSCA directs EPA to take expedited action on chemicals that exhibit characteristics known to present greater risks. Additionally, TSCA authorizes EPA to expedite review of chemicals that present significant risk of serious or widespread harm and initiate enforcement actions against imminently hazardous chemicals.

Requirements for chemicals regulated under TSCA apply to chemicals manufactured in the U.S. and imported into the U.S. TSCA establishes additional procedures for handling imports of chemicals for which EPA has promulgated requirements under the Act. Chemicals marked for export only are subject to recordkeeping and reporting requirements unless EPA has required the development of new information or established a requirement to protect against unreasonable risk.

TSCA authorizes citizen petitions and citizen suits to challenge EPA’s implementation and enforce certain requirements under TSCA through litigation. Additionally, TSCA includes enforcement provisions and establishes civil and criminal penalties for violations.

TSCA does not allow chemical evaluation and restriction to be delegated to states. While states may evaluate and regulate chemicals under their own authorities, TSCA provides an explicit, though limited, preemption of state requirements for chemicals that EPA has evaluated and either determined to present no unreasonable risks or regulated to protect against unreasonable risks. The Act generally preserves long-standing state requirements and allows preemption waivers under certain circumstances.

Congress funds TSCA activities through annual discretionary appropriations. The Act also authorizes EPA to collect fees from chemical manufacturers and processors to partially defray costs that the agency may incur from implementing the statute.

Major sections of TSCA Title I

While the sections in Title I of TSCA number from 2 to 30, the major sections are as follows:

• Section 4 Testing of Chemical Substances and Mixtures — Provides that EPA can issue rules to require companies to generate hazard and exposure information through specific tests or measurements on chemicals in certain circumstances.
• Section 5 Manufacturing and Processing Notices — Prevents future risks through premanufacture screening and regulatory tracking of new chemical products. Significant new use rules can be used to require notice to EPA before new or existing chemical substances and mixtures are used in new ways that might create concerns. EPA can also compile and keep current a list of chemical substances that present or may present an unreasonable risk of injury to human health or the environment.
• Section 6 Prioritization, Risk Evaluation, and Regulation of Hazardous Chemical Substances and Mixtures — Provides for the regulation of hazardous existing chemical substances and mixtures. This includes the control of unreasonable risks already known, risks from polychlorinated biphenyls (PCBs), and risks for existing chemicals that may be discovered in the future.
• Section 8 Reporting and Retention of Information — Requires EPA to gather and disseminate information about chemical production, use, and possible adverse effects to human health and the environment. This section authorizes EPA to maintain the TSCA Inventory.
• Section 9 Relationship to Other Federal Laws — Governs the relationship of TSCA to other federal laws.
• Section 12 Exports — Outlines export notification requirements for any person who exports or intends to export a chemical substance or mixture subject to certain TSCA regulations.
• Section 13 Entry into Customs Territory of the United States — Details import certification requirements that must be met before importing a chemical substance, mixture, or article containing a chemical substance or mixture into the U.S.
• Section 21 Citizens’ Petitions — Allows citizens to petition EPA to take specific regulatory actions on chemicals and mixtures under TSCA.

TSCA Title II Asbestos Hazard Emergency Response

• Title II requires asbestos contractors and analytical laboratories to be certified, and schools to use certified persons for abatement work.
• AHERA authorized EPA to set standards for responding to the presence of asbestos in schools.

Growing public concern about the presence of potentially hazardous asbestos in buildings, especially in schools, led to congressional efforts to address the problem. Toxic Substances Control Act (TSCA) Title II, the Asbestos Hazard Emergency Response Act (AHERA), was enacted in 1986 and amended in July 1988. It required the Environmental Protection Agency (EPA) to set standards by October 1987, for responding to the presence of asbestos in schools.

The standards, set at levels adequate to protect public health and the environment, identify appropriate response actions that depend on the physical condition of asbestos. Schools, in turn, were required to inspect for asbestos-containing material, and to develop and implement a plan for managing any such material. Plans for managing asbestos were to be submitted by schools before May 1989, and implementation was to begin by July 1989. The law contains no deadlines for schools to complete implementation.

Title II also requires asbestos contractors and analytical laboratories to be certified, and schools to use certified persons for abatement work. Training and accreditation requirements also apply to inspectors, contractors, and workers performing asbestos abatement work in all public and commercial buildings. EPA may award training grants to nonprofit organizations for asbestos health and safety programs. However, authorization of appropriations for this grant program expired September 30, 1995. Other Title II requirements (such as mandates that buildings be inspected for asbestos) have not been extended to non-school buildings.

To enforce requirements, TSCA authorizes EPA to take emergency action with respect to schools if school officials do not act to protect children. The Act also authorizes citizen action with respect to asbestos-containing material in a school and to compel action by EPA, either through administrative petition or judicial action. Civil penalties not to exceed $5,000 are authorized for violations such as failing to conduct an inspection or to develop a school management plan.

Concern about how schools would pay for required actions was addressed in separate legislation (the Asbestos School Hazard Abatement Act of 1984, or ASHAA). It established a program offering grants and interest-free loans to schools with serious asbestos problems and demonstrated financial need.

Although EPA for several years did not request funding for this program, Congress appropriated funds. Authorization of appropriations for this program expired September 30, 1995, and Congress has not appropriated funds since fiscal year 1993; a total of $382 million in grant and loan funds were appropriated from fiscal years 1984 through 1993. Repaid ASHAA loans are returned to an Asbestos Trust Fund, established in TSCA Title II, to become a dedicated source of revenues for future asbestos control projects.

TSCA Title III Indoor Radon Abatement

• The basic purpose of Title III is to provide financial and technical assistance to the states that choose to support radon monitoring and control.
• Monitoring nor abatement of radon is required by TSCA.

In October 1988, Congress amended the Toxic Substances Control Act (TSCA) by adding Title III, Indoor Radon Abatement. The basic purpose of Title III is to provide financial and technical assistance to the states that choose to support radon monitoring and control. Neither monitoring nor abatement of radon is required by TSCA.

Title III required the Environmental Protection Agency (EPA) to update its pamphlet “A Citizen’s Guide to Radon,” to develop model construction standards and techniques for controlling radon levels within new buildings, and to provide technical assistance to states. EPA is to provide technical assistance by:

• Establishing an information clearinghouse;
• Publishing public information materials;
• Establishing a national database of radon levels detected, organized by state;
• Providing information to professional organizations representing private firms involved in building design and construction;
• Submitting to Congress a plan for providing financial and technical assistance to states;
• Operating cooperative projects with states;
• Conducting research to develop, test, and evaluate radon measurement methods and protocols;
• Developing and demonstrating new methods of radon measurement and mitigation, including methods that are suitable for use in nonresidential childcare facilities;
• Operating a voluntary program to rate radon measurement and mitigation devices and methods and the effectiveness of private firms and individuals offering radon-related services; and
• Designing and implementing training seminars.

The proficiency rating program and certification for training programs collect fees for service, and therefore are meant to be self-supporting, but Congress authorized $1.5 million to be appropriated to establish these programs. Congress authorized $3 million to be appropriated for each of three years beginning in 1989 for the other provisions of sections 303, 304, and 305.

A matching grant program was established for the purpose of assisting states in developing and implementing programs for radon assessment and mitigation. For this program, $30 million was authorized to be appropriated over three years, with funds targeted to states or projects that made efforts to ensure adoption of EPA’s model construction standards and techniques for new buildings; gave preference to low-income persons; or addressed serious and extensive radon contamination problems or had the potential to reduce risk or to develop innovative assessment techniques, mitigation measures, or management approaches.

Other sections of Title III require EPA to conduct a study to:

• Determine the extent of radon contamination in schools;
• Identify and list areas of the United States with a high probability of having high levels of indoor radon;
• Make grants or cooperative agreements to establish and operate at least three regional radon training centers; and
• Provide guidance to federal agencies on radon measurement, risk assessment, and remedial measures.

All authorizations for appropriations specific to this title expired September 30, 1991, although appropriations have continued.

TSCA Title IV Lead Exposure Reduction

• Title IV aims to accelerate federal efforts to reduce risks to young children who are exposed daily to lead-based paint in their homes.
• Title IV directs EPA to establish a clearinghouse and hotline to distribute information about the hazards of lead-based paint, how to avoid exposure and reduce risk, and new technologies for removing or immobilizing lead-based paint.
• Title IV authorizes states to propose programs to train and certify inspectors and contractors engaged in the detection or control of lead-based paint hazards.

Congress added Title IV to the Toxic Substances Control Act (TSCA) when it enacted the Residential Lead-Based Paint Hazard Reduction Act of 1992 as Title X in the Housing and Community Development Act of 1992. TSCA Title IV aims to accelerate federal efforts to reduce risks to young children who are exposed daily to lead-based paint in their homes. In addition, it was intended to stimulate development of lead inspection and hazard abatement services in the private sector, while ensuring that the services provided and any products employed are reliable and effective in reducing risk. To these ends, Title IV directs the Environmental Protection Agency (EPA) to:

• Promulgate definitions of lead-contaminated dust, lead-contaminated soil, and lead-based paint hazards;
• Ensure that people engaged in detection and control of lead hazards are properly trained and that contractors are certified;
• Publish requirements for the accreditation of training programs for workers;
• Develop criteria to evaluate the effectiveness of commercial products used to detect or reduce risks associated with lead-based paint;
• Establish protocols, criteria, and minimum performance standards for laboratory analysis of lead in paint films, soil, and dust;
• Establish a program to certify laboratories as qualified to test substances for lead content; and
• Publish and distribute to the public a list of certified or accredited environmental sampling laboratories.

Title IV explicitly applies these requirements to federal facilities and activities that may create a lead hazard. In addition, Congress directed EPA to conduct a study of lead hazards due to renovation and remodeling activities that may incidentally disturb lead-based paint. EPA is required to promulgate guidelines for the renovation and remodeling of buildings or other structures when these activities might create a hazard.

Title IV directs EPA to establish a clearinghouse and hotline to distribute information about the hazards of lead-based paint, how to avoid exposure and reduce risk, and new technologies for removing or immobilizing lead-based paint. In addition, Congress mandated development of a lead hazard information pamphlet; public education and outreach activities for health professionals, the general public, homeowners, landlords, tenants, consumers of home improvement products, the residential real estate industry, and the home renovation industry; and information to be distributed by retailers of home improvement products to provide consumers with practical information related to the hazards of renovation where lead-based paint may be present.

Title IV authorizes states to propose programs to train and certify inspectors and contractors engaged in the detection or control of lead-based paint hazards. States also may develop the required informational pamphlets. TSCA requires EPA to promulgate a model state program that may be adopted by any state. Congress gave EPA the authority to approve or disapprove authorization for state proposals and to provide grants for states to develop and implement authorized programs. A federal program must be established, administered, and enforced by EPA in each state without an authorized program.

The Department of Health and Human Services also has responsibilities under Title IV of TSCA. It mandates a study by the Centers for Disease Prevention and Control (CDC) and the National Institute for Environmental Health Sciences to determine the sources of lead exposure to children who have elevated lead levels in their bodies. The National Institute for Occupational Safety and Health (NIOSH) is directed to study ways of reducing occupational exposure to lead during abatement activities.

The Act established a rulemaking docket to ensure the availability to the general public of all documents submitted to agencies that are relevant to regulatory decisions pursuant to this legislation. The docket is required to include the drafts of all proposed rules submitted by EPA to the White House Office of Management and Budget (OMB), written comments on the drafts, and written responses to comments. EPA must provide an explanation for any major change to a proposed rule that appears in a final rule, and such changes may not be made based on information not filed in the docket. Dockets are required to be established in each EPA regional office.

In addition to amending TSCA, Title X of the Housing and Community Development Act of 1992 authorized:

• Grants to states for risk assessments and lead-based paint removal and immobilization in private housing for low-income residents;
• State training, certification, or accreditation programs for inspectors and abatement contractors; and
• Research at the Department of Housing and Urban Development (HUD).

Authorization for appropriations for these grants expired September 30, 1994, but appropriations have continued. Title X directed HUD to establish guidelines for federally supported work involving risk assessments, inspections, interim controls, and abatement of lead-based paint hazards. In addition, the NIOSH was provided $10 million for training people who remove or immobilize paint.

Finally, Congress authorized to be appropriated “such sums as may be necessary” for TSCA Title IV.

TSCA Title V Healthy High-Performance Schools

• Title V authorizes EPA to establish a state grant program to provide assistance for EPA programs to schools and develop and implement state school environmental health programs.
• The EPA Administrator is directed to prepare an annual report to Congress on activities carried out under Title V authority.

At the end of 2007, Congress added a fifth title to the Toxic Substances Control Act (TSCA), subtitled Healthy High-Performance Schools. Enacted as Title IV, Subtitle E (section 461) of Public Law 110-140, the Energy Independence and Security Act of 2007, TSCA Title V authorizes the Environmental Protection Agency (EPA) to establish a state grant program to provide technical assistance for EPA programs to schools and develop and implement state school environmental health programs.

State programs must include standards for school building design, construction, and renovation, and identify ongoing school building environmental problems and recommended solutions. Environmental problems specifically mentioned in the law include “contaminants, hazardous substances, and pollutant emissions.” EPA’s authority to provide grants expired five years after the date of enactment.

Title V required the EPA Administrator, in consultation with the Secretary of Education and the Secretary of Health and Human Services, to issue voluntary guidelines within 18 months of Title V enactment for selecting sites for schools (presumably new schools). The guidelines are to account for the “special vulnerability of children to hazardous substances or pollution exposures in any case in which the potential for contamination at a potential school site exists,” modes of transportation available to students and staff, efficient use of energy, and potential use of a school at the site as an emergency shelter.

Title V also required the EPA Administrator, in consultation with the Secretary of Education and the Secretary of Health and Human Services, to issue voluntary guidelines within two years of enactment for developing and implementing state environmental health programs for schools. These guidelines had to take into account the findings of federal initiatives established under “relevant federal law with respect to school facilities,” including initiatives related to water and energy conservation authorized by sections 431 through 441, and work related to high performance green buildings authorized by section 492 of Public Law 110-140. In particular, the guidelines had to take into account:

• Environmental problems, contaminants, hazardous substances, and pollutant emissions;
• Natural day lighting;
• Ventilation;
• Heating and cooling;
• Moisture control and mold;
• Maintenance, cleaning, and pest control;
• Acoustics; and
• Other issues relating to the health, comfort, productivity, and performance of occupants of the school facilities.

In addition, Title V required that the guidelines:

• Provide technical assistance on siting, design, management, and operation of school facilities;
• Collaborate with children’s environmental health centers in school environmental investigations;
• Assist states and the public to better understand and improve the environmental health of children; and
• Take into account “the special vulnerability of children in low-income and minority communities to exposures from contaminants, hazardous substances, and pollutant emissions.”

Several provisions in Title V refer to entities established under other sections of the Energy Independence and Security Act of 2007. For example, Title V contains directives for the Federal Director of the Office of Federal High-Performance Green Buildings in the General Services Administration, which was created by section 436(a).

In addition, there is reference to the national high-performance green building clearinghouse established in section 423(1). Title V requires the Federal Director to ensure as much as possible, that the public clearinghouse “receives and makes available information on the exposure of children to environmental hazards in school facilities.” The EPA Administrator is directed to prepare an annual report to Congress on activities carried out under Title V authority, and this report also must be made available to the public through the clearinghouse.

For the purposes of carrying out the provisions of Title V, Congress authorized appropriations of $1.5 million annually through 2013.

TSCA Title VI Formaldehyde Standards for Composite Wood Products

• Title VI mandates specific formaldehyde emission standards for hardwood plywood, medium-density fiberboard, and particleboard that is sold, supplied, offered for sale, or manufactured in the United States.

In July 2010, Congress enacted the Formaldehyde Standards for Composite Wood Products Act, adding a new Title VI to the Toxic Substances Control Act (TSCA). Title VI mandates specific formaldehyde emission standards for hardwood plywood, medium-density fiberboard, and particleboard that is sold, supplied, offered for sale, or manufactured in the United States.

The standards are phased in over two years from enactment and are based on Method ASTM E-1333-96 (2002), the voluntary national formaldehyde emissions standards established by ASTM International (formerly known as the American Society for Testing and Materials).

The standards apply to plywood, particleboard, and medium-density fiberboard in the form of an unfinished panel or incorporated into a finished good. Certain products are excluded, including many forms of lumber and panels used for outdoor applications, such as structural plywood, prefabricated wood I-joists, most windows, antiques or other previously owned goods, and composite wood products used inside automobiles, trucks, rail cars, boats, and aircraft.

The Environmental Protection Agency (EPA) was required to promulgate regulations ensuring compliance with the emission standards and had to include provisions related to:

• Labeling, chain of custody requirements, and sell-through provisions;
• Ultra-low-emitting formaldehyde resins, finished goods, and third-party testing and certification;
• Auditing and reporting of third-party certifiers;
• Recordkeeping;
• Enforcement;
• Laminated products; and
• Exceptions for products and components containing “de minimis amounts” of composite wood products.

The regulations are found at 40 CFR 770.

Title VI prohibits stockpiling of products manufactured before the effective date of the Act for sale after that date. Also prohibited is any requirement for labeling products manufactured prior to the “designated date of manufacture.”

Title VI requires an annual report to Congress on the status of implementation and the extent to which relevant industries have achieved compliance. Finally, the Act directs the Secretary of Housing and Urban Development to update regulations concerning formaldehyde emissions from composite wood in manufactured homes (24 CFR 3280.308) to ensure that the standards established by TSCA Title VI are implemented.

U.S. code sections related to TSCA sections

• Each subchapter of TSCA ties directly to the U.S. Code. This table shows only the major code sections of the Toxic Substances Control Act (TSCA). Facilities will want to consult the official U.S. Code for further details.

Regulations related to TSCA

• Most regulations implementing the TSCA statutes can be found at 40 CFR Parts 700 to 799.

Most regulations implementing the Toxic Substances Control Act (TSCA) statutes can be found at 40 CFR Parts 700 to 799. These regulations are listed below and enforced by the Environmental Protection Agency (EPA):

Covered and excluded substances

• Congress generally excluded from TSCA regulation groups of chemicals where the risks were considered sufficiently addressed under such other laws.
• Articles (i.e., manufactured items) that contain chemical substances subject to TSCA may be regulated by the Act to the extent that those chemical substances present an unreasonable risk or meet other criteria.

The Toxic Substances Control Act (TSCA) applies to chemical substances, which the statute defines broadly to include substances that have a “particular molecular identity.” This includes:

• Any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and
• Any element or uncombined radical.

It is important to note that the term chemical substance also includes microorganisms. A microorganism is defined as “an organism classified, using the five-kingdom classification system of Whittacker, in the kingdoms Monera (or Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of the Plantae, and a virus or virus-like particle.”

Exclusions

To avoid redundancy with other federal pollution control and public health laws, Congress generally excluded from regulation groups of chemicals where the risks were considered sufficiently addressed under such other laws. Congress also specifically excluded the following substances without regard to their regulation under other laws:

• Pesticides when manufactured, processed, or distributed in commerce for use as a pesticide;
• Tobacco and tobacco products;
• Certain radioactive materials;
• Firearms (including pistols and revolvers), shells, cartridges, and their components;
• Food (including poultry, meat, and eggs), food additives (including food contact substances), drugs, cosmetics, and medical devices; and
• Mixtures (see note below).

Since the exclusions are generally framed based on the intended uses of a chemical substance (e.g., a pesticide), the same chemical substance may be subject to TSCA and other federal pollution control and public health laws depending on the intended use. For example, the Environmental Protection Agency (EPA) has examined the risks of bisphenol A under TSCA with regard to its use in manufacturing polycarbonate plastics and epoxy resins. However, the use of bisphenol A as a food contact substance is not covered by TSCA based on the statutory exclusion.

Note on mixtures and articles

Although the definition of a chemical substance excludes mixtures, multiple TSCA provisions apply to mixtures. A mixture is defined as:

• Any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; or
• Any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.

Generally, a mixture is subject to requirements under TSCA if the requirements that pertain to its constituent chemical substances will not result in adequate evaluation or control of the risks anticipated from the mixture.

Additionally, as a practical matter, articles (i.e., manufactured items) that contain chemical substances subject to TSCA may be regulated by the Act to the extent that those chemical substances present an unreasonable risk or meet other criteria.

Limitations on authority

• EPA must make an unreasonable risk finding or determination before requiring information on, or regulating, a chemical.
• Even if EPA concludes under TSCA that a chemical presents an unreasonable risk, TSCA provides that other federal laws supersede EPA’s authority under TSCA to address unreasonable risks.

In addition to excluding groups of chemicals from the scope of chemicals covered under the Toxic Substances Control Act (TSCA), Congress generally limited the extent to which the Environmental Protection Agency (EPA) may regulate a chemical.

Unreasonable risk threshold

EPA cannot simply regulate a chemical at will. The agency must make an unreasonable risk finding or determination before requiring information on, or regulating, a chemical. The trouble is TSCA does not explicitly define what constitutes an unreasonable risk. In 1991, the U.S. Court of Appeals for the Fifth Circuit held that the “unreasonable risk” standard as originally set forth in TSCA meant that “[i]n evaluating what is ‘unreasonable,’ the EPA is required to consider the costs of any proposed actions and to ‘carry out this chapter in a reasonable and prudent manner [after considering] the environmental, economic, and social impact of any action.’” This interpretation led the court to vacate parts of the 1989 EPA rule that regulated various asbestos uses.

Though the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) did not amend TSCA to explicitly define unreasonable risk, it prohibited EPA from considering cost or nonrisk factors when evaluating risks. However, EPA must consider “reasonably ascertainable economic consequences” and other nonrisk factors when restricting uses of a chemical. Additionally, the LCSA codified existing agency practice to consider risks for “potentially exposed or susceptible subpopulations” when evaluating the risks of a chemical.

Relationship with other federal laws

Even if EPA concludes under TSCA that a chemical presents an unreasonable risk, TSCA provides that other federal laws supersede EPA’s authority under TSCA to address unreasonable risks. If EPA determines that a risk associated with a chemical may be sufficiently eliminated or reduced by actions taken under other federal laws that the agency administers, section 9(b) of the Act requires the agency to use those authorities to protect against the risk unless the agency determines that it is in the public interest to take action under TSCA.

If EPA determines that a chemical presents an unreasonable risk that may be sufficiently prevented or reduced by action taken under a federal law a different federal agency administers, section 9(a) directs EPA to submit to that other agency a report describing the risk and a request for a response. A federal agency that receives such a report from EPA must respond within 90 days (or a shorter period if specified by EPA). If that federal agency issues an order disagreeing with EPA about the unreasonable risk or initiates action to protect against such risk, then EPA may not regulate the chemical under TSCA.

Adding chemicals to the Inventory

• Once a complete NOC is received by EPA, the reported substance is considered to be on the Inventory and becomes an “existing chemical.”

After a premanufacture notice (PMN) review has been completed, the company that submitted the PMN must provide a Notice of Commencement of Manufacture or Import (NOC, EPA Form 7710-56) to the Environmental Protection Agency (EPA) within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.

Once a complete NOC is received by EPA, the reported substance is considered to be on the Inventory and becomes an “existing chemical.” The agency receives approximately 400 NOCs each year, thus the TSCA Inventory changes almost daily.

Substances reported through exemption submissions and exempt uses that are not subject to reporting do not require an NOC and are not added to the Inventory. Examples include:

• Low Volume Exemptions (LVEs),
• Low Release/Low Exposure Exemptions (LoREXs),
• Test Market Exemptions (TMEs),
• Substances used for research and development, and
• Polymers that meet the 1995 Polymer Exemption Rule Amendments.

Accessing the Inventory

• EPA provides free access to the non-confidential portion of the TSCA Inventory online.
• EPA provides a database management system version and a generic comma-delimited "CSV" text version of the TSCA Inventory.
• The TSCA Inventory can be searched in multiple ways.
• Someone with a valid commercial need for the EPA to verify if a substance is on the inventory can submit a bona fide notice to obtain a written determination from EPA.

Determining if a chemical is on the Inventory is a critical step before beginning to manufacture (which includes importing) a chemical substance. Section 5 of the Toxic Substances Control Act (TSCA) requires anyone who plans to manufacture a new chemical substance for a non-exempt commercial purpose to provide the Environmental Protection Agency (EPA) with a premanufacture notice (PMN) at least 90 days before initiating the activity.

As part of EPA’s commitment to strengthen the management of chemicals and increase information on chemicals, the agency provides free access to the non-confidential portion of the TSCA Inventory online.

Downloading the non-confidential TSCA Inventory

The non-confidential portion of EPA’s TSCA Inventory is updated approximately every six months. EPA provides a database management system version and a generic comma-delimited "CSV" text version of the non-confidential TSCA Inventory for users to download. Facilities that don’t have the database management system that EPA uses will instead use the CSV file.

Both files are compressed ".zip" files. The .zip files contain the actual data files. With either version, the file contains two tables:

• The TSCAINV … file contains non-confidential chemical substance listings on the TSCA Inventory, as identified by Chemical Abstracts Service (CAS) Registry Number and Chemical Abstracts (CA) Index Name.
• The PMNACC … file contains non-confidential data for the confidential chemical substance listings, as identified by EPA accession number and generic chemical name.

For all files, users may need to adjust formatting, including column widths. Use a basic "find" search function and type in a part of a chemical name or CAS Registry Number to find information.

Alternate access of the non-confidential TSCA Inventory

In addition to downloading a database management system version and a generic comma-delimited "CSV" text version, the non-confidential Toxic Substances Control Act (TSCA) Inventory can be searched in multiple ways:

• Use EPA's Substance Registry Services (SRS) to search the non-confidential TSCA Inventory:
  • Go to Substance Registry Services webpage.
  • Select the “search by list" option.
  • Type "TSCA Inventory" in the List Name field.
  • Click the "filter" button and select "TSCA Inventory – TSCA Inv" from the drop-down list.

• Look at other sources of EPA’s non-confidential TSCA Inventory data such as:
  • Government Printing Office (GPO) website no longer provides paper copies of the original 1985 TSCA Inventory publication or the 1990 Supplement; however, it can provide expert assistance in finding and using related U.S. government information.
  • Several commercial services provide searches for the non-confidential TSCA Inventory for a fee. None of these is connected to or has a specific endorsement from EPA.

Submitting notices of bona fide intent to manufacture

Someone with a valid commercial need for EPA to verify if a substance is on the inventory can submit a Bona Fide Intent to Manufacture or Import Notice (bona fide notice) to obtain a written determination from EPA.

In a bona fide notice, a submitter must provide specific chemical identification data including:

• Chemical Abstracts (CA) Index name. Proper CIndex names can be obtained from the Chemical Abstracts Service's Inventory Expert Service;
• Information about the manufacture or importation of the substance;
• Letter of support if some information (e.g. specific chemical identity) has been withheld from the submitter by the supplier;
• Certification of intent to manufacture or import the substance for a commercial purpose; and
• All of the other information required in support of a bona fide notice.

EPA will consider the information submitted in a bona fide notice and, if the agency believes that the submitter has demonstrated a genuine intent to manufacture or import, search the full TSCA Inventory master file and provide a written determination to the submitter on the TSCA Inventory status for the chemical substance.

The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA's Central Data Exchange (CDX), to submit TSCA section 5 notices to the Agency. These notices include the bona fide notices.

Correcting the Inventory

• TSCA Chemical Substance Inventory Reporting Form C provides the chemical industry a method to submit requests to EPA’s OPPT for correcting misreported chemical identities of substances listed on the Inventory.

Shortly after the first Toxic Substances Control Act (TSCA) Inventory was published in 1979, the Environmental Protection Agency (EPA) determined that reported substances may have been unintentionally misidentified as a result of simple typographical errors, the misidentification of substances, or the lack of sufficient technical or analytical capabilities to characterize the exact chemical substances.

TSCA Chemical Substance Inventory Reporting Form C (EPA Form 7710-3C) provides the chemical industry with a method to submit requests to EPA’s Office of Pollution Prevention and Toxics (OPPT) for correcting misreported chemical identities of substances listed on the Inventory. Such requests pertain only to errors discovered in the original submissions to the Inventory when the Inventory was first established in 1979.

The correction mechanism allows the submitter to add the correct substance to the Inventory without having to file a premanufacture notice (PMN) under TSCA section 5. The correction mechanism ensures the accuracy of the Inventory without imposing an unreasonable burden on the chemical industry. Without the Inventory correction mechanism, a submitter would have to file a PMN to place the correct chemical substance on the Inventory whenever finding that the previously reported substance was misidentified.

Historical notes

• TSCA requires EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce.
• TSCA requires EPA to establish a rule on CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory Notification Requirements Rule.

The initial reporting period by manufacturers, processors and importers was January to May of 1978 for chemical substances that had been in commerce since January of 1975. The Environmental Protection Agency (EPA) subsequently compiled and published the Toxic Substances Control Act (TSCA) Inventory in 1979. A second version was published in 1982.

Today, the TSCA Inventory is updated every six months. It is noteworthy that three actions in modern history have shaped the latest TSCA Inventory. They include the:

• TSCA Inventory Notification (Active-Inactive) rule (also called the Inventory Reset rule), August 11, 2017;
• Procedures for Review of Confidential Business Information Claims for the Identity of Chemicals on the Toxic Substances Control Act Inventory rule, March 6, 2020; and
• EPA Extends Notification Deadline for Updates to Confidential Status of Chemicals on the TSCA Inventory; EPA announcement, May 14, 2021.

Inventory reset rule

TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, requires EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce.

To accomplish that, EPA finalized a rule requiring industry reporting of chemicals manufactured (including imported) or processed in the U.S. over a 10-year period ending on June 21, 2016. This reporting was completed on October 5, 2018, and was used to identify chemical substances on the TSCA Inventory as active or inactive in U.S. commerce.

EPA includes the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. Starting August 5, 2019, manufacturers and processors were required to notify EPA before reintroducing inactive substances into U.S. commerce. Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX). Upon receiving such notification, EPA will change the commercial activity designation of inactive substances to active.

On October 13, 2021, EPA remarked that the Inventory contained 86,607 chemicals of which 41,953 were active in U.S. commerce.

Review of CBI claims rule

Section 8(b) of TSCA requires EPA to establish a rule on confidential business information (CBI) claims for specific chemical identities for chemicals reported as “active” in U.S. commerce in response to the TSCA Inventory Notification (Active-Inactive) Requirements Rule.

On March 6, 2020, EPA finalized a rule on the procedures for companies to substantiate their CBI claims for the specific chemical identities of substances on the TSCA inventory, as well as the plan for how the agency will review the claims, the timeframes for EPA to complete reviews, and the annual posting of results.

The final rule also included two additional questions on reverse engineering that manufacturers and processors will be required to answer to substantiate their specific chemical identity CBI claims. These two questions were added as part of the agency's response to a court-ordered remand of part of the TSCA Inventory Notification (Active-Inactive) Requirements Rule. The rule amended existing sections of 40 CFR 710 and added 40 CFR 710 Subpart C.

Updates to confidential status of chemicals

In April 2021, EPA posted a list of 390 chemicals by accession number expected to lose their confidential chemical identity status and move to the public portion of the TSCA Inventory and gave stakeholders a deadline of May 14, 2021, to notify the agency of any errors on the list. In response to industry stakeholder requests for additional time to review this list, EPA extended the notification deadline to June 30, 2021.

EPA planned to declassify the specific identities of these chemicals because they were reported as non-confidential by one or more manufacturers during the 2012, 2016, and/or 2020 Chemical Data Reporting (CDR) reporting periods — meaning that at least one manufacturer did not request that each of these chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S commerce.

On October 13, 2021, EPA announced that the agency updated the confidential status of 377 chemical identities and would include these chemical identities on the winter 2022 TSCA Inventory. The 377 declassified specific chemical identities were made available with the October 13, 2021, announcement.

Premanufacture notice (PMN)

• "Existing" chemicals are chemicals that were already in commerce when TSCA was enacted in 1976 or chemicals that have undergone PMN review and are listed on the TSCA Inventory.

Under Toxic Substances Control Act (TSCA) section 5, chemical manufacturers (or importers) must submit a notice to the Environmental Protection Agency (EPA) at least 90 days prior to the initial commercial manufacture (or import) of a new chemical substance, unless the chemical substance meets certain criteria for an exemption from notification. This notification is known as a premanufacture notice (PMN). According to EPA, the agency has received more than 40,000 PMNs since the enactment of TSCA in 1976.

Introduction

Mandated by section 5 of TSCA, EPA's New Chemicals program helps manage the potential risk to human health and the environment from chemicals new to the marketplace. The program functions as a "gatekeeper" that 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.

For purposes of regulation under TSCA, if a chemical is on the TSCA Inventory, the substance is considered an "existing" chemical substance in U.S. commerce. "Existing" chemicals are chemicals that were already in commerce when TSCA was enacted in 1976 or chemicals that have undergone PMN review and are listed on the TSCA Inventory.

Who must submit a PMN?

Section 5 of TSCA requires anyone who plans to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to provide EPA with notice before initiating the activity. This notice is known as a PMN. Refer to the chart below that details steps for determining whether a submission is required on a chemical substance.

PMN submission process

• Submitters must use EPA’s CDX to submit TSCA section 5 notices and supporting documents electronically.
• Six types of submitters may register with CDX.

Submitters must use the Environmental Protection Agency’s (EPA’s) Central Data Exchange (CDX) to submit Toxic Substances Control Act (TSCA) section 5 notices and supporting documents electronically.

Premanufacture notice (PMN) submissions must be made on EPA Form 7710-25 using the electronic PMN software (e-PMN). The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA's CDX, to submit TSCA section 5 notices to the EPA. These notices include, but are not limited to:

• PMNs;
• Bona Fide Notices;
• Biotechnology Notices for genetically modified microorganisms;
• Notices of Commencement of Manufacture (including Import) (NOCs); and
• Support documents for section 5 notices (e.g., correspondence, requests for suspensions of the notice review period, amendments, letters of withdrawal, Transfer of Ownership, and test data).

The PMN form should also be used to submit:

• Test Market Exemption applications (TMEAs);
• Low Volume Exemption (LVE) notices and modifications;
• Low Exposure / Low Release (LoREX) exemption notices and modifications; and
• Mock PMNs.

In order to submit documents electronically to EPA, fill out PMN forms using the e-PMN software and submit through the CDX. To access CDX, pre-register with CDX and be approved by EPA. In order to access and use the new e-PMN software, all users must register with CDX for the Chemical Safety and Pesticide Programs (CSPP) program service.

Six types of submitters may register with CDX:

• Primary Authorized Officials,
• Primary Agents/Consultants,
• Primary Supports,
• Secondary Authorized Officials,
• Secondary Agents/Consultants, and
• Secondary Supports.

If there are technical issues or problems regarding the e-PMN software or CDX registration, contact the CDX Help Desk at helpdesk@epacdx.net or (888) 890-1995. International callers who wish to contact the Help Desk should call (970) 494-5500.

Note that the previous version of e-PMN software called eTSCA software can no longer be used to submit directly/electronically via CDX.

Microbial Commercial Activity Notice (MCAN)

• Persons who wish to commercialize an intergeneric microorganism must submit a MCAN to EPA at least 90 days prior to commercialization.

Toxic Substances Control Act (TSCA) section 5, as interpreted in EPA’s Microbial Products of Biotechnology final rule (April 11, 1997), authorizes EPA to regulate new genetically engineered microorganisms.

According to the rule, new microorganisms are those that, through deliberate human intervention, contain genetic material from dissimilar source organisms. Specifically, intergeneric microorganisms are those formed by either the deliberate combination of genetic material from organisms classified in different taxonomic genera or constructed with synthetic genes that are not identical in DNA that would be derived from the same genus as the recipient microorganism.

Section 5 of TSCA requires the submission of certain information to EPA if a person wishes to:

• Commercialize an intergeneric microorganism; or
• Introduce such microorganisms into the environment for research purposes.

Persons who wish to commercialize an intergeneric microorganism must submit a Microbial Commercial Activity Notice (MCAN) to EPA at least 90 days prior to commercialization. These microorganisms are subject to the same determinations and potential regulatory controls as new chemical substances that undergo the premanufacture notice (PMN) notification and review process.

The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA's Central Data Exchange (CDX), to submit TSCA section 5 notices to EPA. There is no required format for biotech submissions in the e-PMN software; therefore, in the “Forms” screen of the e-PMN program, a submitter should choose to create a new form and then select "Biotechnology." Submitters will be required to enter contact information regarding the submitting company and the technical contact. (EPA offers a sample header sheet, entitled “EPA Biotech Form” for anyone to view.)

MCAN is one of the five biotechnology submission choices. After selecting a submission type, the submitter can enter the submission information in a cover letter and as attachments.

After PMN or MCAN submission

• EPA’s new chemicals review process for active cases under review includes eight key stages.
• If the substance is determined “not likely to present an unreasonable risk,” the submitter of the PMN or MCAN must provide an NOC to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.
• The chemical substance is considered to be on the TSCA Inventory as soon as a complete NOC is received by EPA.

After submission of a premanufacture notice (PMN) or Microbial Commercial Activity Notice (MCAN), the notice goes through several stages of review.

1. Pre-submission,
2. Incoming cases,
3. Risk assessment,
4. Risk characterization,
5. Awaiting submitter information/action,
6. Regulatory decision and action development,
7. Awaiting submitter signature on consent order, and
8. Final determination.

If the Environmental Protection Agency (EPA) fails to make a determination, fees may be refunded; however, nothing relieves EPA of its obligation to make a determination.

Notice of commencement

Under Toxic Substances Control Act (TSCA) section 5(g), when EPA makes a determination that a chemical substance or microorganism is “not likely to present an unreasonable risk,” the submitter of the PMN or MCAN may commence manufacture of the substance, notwithstanding any remaining portion of the applicable review period. If manufacture is commenced, then:

• The submitter of the PMN or MCAN must provide a Notice of Commencement of Manufacture or Import Form (NOC) to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.
• NOCs must be submitted electronically to EPA.
• The chemical substance is considered to be on the TSCA Inventory as soon as a complete NOC is received by EPA. Actual EPA processing of the NOC to complete the transaction takes about four weeks.
• Excess research and development substances may be used or sold after expiration of the PMN review period and does not require submission of an NOC. The substance will not be placed on the Inventory until an NOC is received; however, an NOC may not be submitted for the substance before commercial manufacture (non-research and development) begins.

New chemicals and microorganisms are added to the TSCA Inventory after the PMN or MCAN review period has completed and the PMN or MCAN submitter has commenced nonexempt commercial manufacture.

Prioritization

• Prioritization is a risk-based screening process for designating chemical substances as High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluation is not warranted at the time.

The first step in the Environmental Protection Agency’s (EPA’s) process for evaluating the safety of existing chemicals is prioritization. Prioritization is a risk-based screening process for designating chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluation is not warranted at the time.

The Toxic Substances Control Act (TSCA) requires EPA to give certain preferences to prioritizing chemicals on the 2014 TSCA Work Plan, to consider certain criteria such as hazard/exposure, persistence, and bioaccumulation, but otherwise does not significantly limit EPA's discretion to choose which chemicals enter the prioritization process. TSCA further prohibits EPA from considering non-risk factors (e.g., costs/benefits) during prioritization.

Once initiated, the process provides stakeholders with ample notice of any EPA risk evaluation activity, as well as two opportunities for the public to submit relevant information to the agency. The process has been designed to ensure that EPA’s limited resources are focused on chemicals with the greatest potential for risk.

Chemical substances with low hazard and/or exposure that meet the definition of Low-Priority Substances are taken out of consideration for further assessment at this time. This gives the public notice of chemical substances for which the hazard and/or exposure potential is anticipated to be low or nonexistent and provides insight into which chemical substances are likely not to need additional evaluation and risk management.

The following flowchart provides an overview of EPA’s chemical prioritization process:

Risk evaluation

• If EPA designates a chemical as a High-Priority Substance, the chemical moves immediately to the risk evaluation phase.

The second step in the Environmental Protection Agency’s (EPA’s) process for evaluating the safety of existing chemicals is risk evaluation. If EPA designates a chemical as a High-Priority Substance, the chemical moves immediately to the risk evaluation phase. At the conclusion of the risk evaluation phase, EPA must use the risk evaluation as a basis to determine whether or not the chemical presents an unreasonable risk to health or the environment under the chemical’s conditions of use.

The Toxic Substances Control Act (TSCA) prohibits EPA from considering non-risk factors (e.g., costs/benefits) during risk evaluation. This includes risks to subpopulations who may be at greater risks than the general population, such as children and workers.

The risk evaluation process has the following components:

• A scope document that provides the public with information on the focus of the risk evaluation;
• Hazard and exposure assessments and a risk characterization to inform the risk determination; and
• A risk determination stating whether or not a chemical substance presents an unreasonable risk to health or the environment under its conditions of use.

In addition to EPA’s prioritization process, TSCA allows manufacturers to request that EPA conduct a risk evaluation on a particular chemical. When this happens, manufacturers are required to provide EPA with the information necessary to conduct a risk evaluation on those conditions of use that are of interest to them. Like the prioritization process, the risk evaluation process affords opportunities for public comment and submission of relevant information.

Risk management

• If at the end of the risk evaluation process, EPA determines that a chemical presents an unreasonable risk to health or the environment, the chemical must immediately move to risk management action under TSCA.
• EPA is required to implement, via regulation, regulatory restrictions on the manufacture, processing, distribution, use, or disposal of the chemical to eliminate the unreasonable risk.

The third step in the Environmental Protection Agency’s (EPA’s) existing chemicals process is risk management. Generally, risk management is the last step in the process and starts after publication of a chemical’s final risk evaluation showing unreasonable risks. If at the end of the risk evaluation process, the agency determines that a chemical presents an unreasonable risk to health or the environment, the chemical must immediately move to risk management action under the Toxic Substances Control Act (TSCA).

EPA is required to implement, via regulation, regulatory restrictions on the manufacture, processing, distribution, use, or disposal of the chemical to eliminate the unreasonable risk. The agency is given a range of risk management options under TSCA, including labeling, recordkeeping or notice requirements, actions to reduce human exposure or environmental release, and a ban of the chemical or of certain uses.

TSCA requires EPA to issue a:

• Proposed risk management rule under TSCA section 6(a) for the chemical substance no later than one year after the date on which the final risk evaluation regarding the chemical substance is published, and
• Final rule no later than two years after the publication date of the final risk evaluation.

Input from all stakeholders is critical to the risk management process. Like the prioritization and risk evaluation processes, there is an opportunity for public comment on any proposed risk management actions.

Asbestos

• TSCA Title II AHERA program governs the management of asbestos in K-12 schools.
• TSCA section 6 WPR protects state and local government employees who are not protected by the federal OSHA asbestos standards.
• EPA has issued a risk evaluation of asbestos and is working toward a supplemental risk evaluation. The risk management step comes after risk evaluation.

Asbestos is a mineral fiber that occurs in rock and soil. Exposure to asbestos increases risk of developing lung disease. That risk is made worse by smoking. In general, the greater the exposure to asbestos, the greater the chance of developing harmful health effects.

Asbestos fibers may be released into the air by the disturbance of asbestos-containing material during product use, demolition work, building or home maintenance, repair, and remodeling. In general, exposure may occur only when the asbestos-containing material is disturbed or damaged in some way to release particles and fibers into the air. Where asbestos may be found, includes the following:

• Attic and wall insulation containing vermiculite,
• Vinyl floor tiles and the backing on vinyl sheet flooring and adhesives,
• Roofing and siding shingles,
• Textured paint and patching compounds used on walls and ceilings,
• Walls and floors around wood-burning stoves protected with asbestos paper, millboard, or cement sheets,
• Hot water and steam pipes coated with asbestos material or covered with an asbestos blanket or tape,
• Oil and coal furnaces and door gaskets with asbestos insulation,
• Heat-resistant fabrics, and
• Automobile clutches and brakes.

Asbestos in schools

The Toxic Substances Control Act (TSCA) Title II Asbestos Hazard Emergency Response Act (AHERA) program (also called the Asbestos in Schools Program) governs the management of asbestos in Kindergarten through Grade 12 schools. The objective of AHERA compliance monitoring is to ensure regulatory compliance and, thereby, minimize the risk of exposure to asbestos in schools. Implementing regulations are found at 40 CFR 763 and require public school districts and non-profit schools to:

• Perform an original inspection to determine whether asbestos-containing materials are present and then re-inspect asbestos-containing material in each school every three years;
• Develop, maintain, and update an asbestos management plan and keep a copy at the school;
• Provide yearly notification to parent, teacher, and employee organizations on the availability of the school's asbestos management plan and any asbestos-related actions taken or planned in the school;
• Designate a contact person to ensure the responsibilities of the public school district or the non-profit school are properly implemented;
• Perform periodic surveillance of known or suspected asbestos-containing building material;
• Ensure that trained and licensed professionals perform inspections and take response actions; and Provide custodial staff with asbestos-awareness training.

These legal requirements are founded on the principle of "in-place" management of asbestos-containing material. Removal of these materials is not usually necessary unless the material is severely damaged or will be disturbed by a building demolition or renovation project.

Other TSCA actions related to asbestos

The TSCA section 6 Worker Protection Rule (WPR) protects state and local government employees who are not protected by the federal Occupational Safety and Health Administration (OSHA) asbestos standards.

Other actions to protect the public from exposure to asbestos under the TSCA include the following:

• July 1989 partial ban — In 1989, the Environmental Protection Agency (EPA) attempted to ban most asbestos-containing products by issuing a final rule under section 6 of TSCA. However, most of the original ban on the manufacture, importation, processing, or distribution in commerce for the majority of the asbestos-containing products originally covered in the 1989 final rule was overturned in 1991 by the Fifth Circuit Court of Appeals. As a result, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated for the first time after August 25, 1989, and bans five other specific product types.
• April 2019 restrictions on discontinued uses of asbestos rule — This rule aims to ensure that asbestos products that are no longer on the market cannot return to commerce without EPA evaluating them and putting in place any necessary restrictions or prohibiting use. The uses covered under this rule were not already prohibited under TSCA and could have returned to the market at any time. The rule closed that loophole.
• December 2020 final risk evaluation for asbestos, part 1: chrysotile asbestos — This risk evaluation found unreasonable risks to human health for ongoing uses of chrysotile asbestos and no unreasonable risk to the environment from any condition of use. EPA is moving immediately to risk management for the ongoing chrysotile asbestos use where unreasonable risk was found and will work as quickly as possible to propose and finalize actions to protect against the unreasonable risks.
• December 2021 draft scope for risk evaluation for asbestos, part 2: supplemental evaluation including legacy uses and associated disposals of asbestos — The draft scope includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. For part 2 of the risk evaluation for asbestos, EPA:
  • Has adopted the definition of asbestos as defined by TSCA Title II Section 202 as the “asbestiform varieties of six fiber types – chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.”
  • Will consider Libby Amphibole Asbestos (and its tremolite, winchite, and richterite constituents).
  • Will assess the relevant conditions of use of asbestos in talc or talc-containing products, because talc has been implicated as a potential source of asbestos exposure.

It should be noted that asbestos is also regulated by other EPA, OSHA, Mine Safety and Health Administration (MSHA), and Department of Transportation (DOT) regulations, and these regulations are beyond the scope of TSCA. EPA regulation 40 CFR 61 Subpart M offers a list of these other regulations.

Formaldehyde

• The Formaldehyde Standards for Composite Wood Products Act aims to reduce emissions of formaldehyde from composite wood products by establishing formaldehyde emissions limits.
• All entities along the supply chain, from the manufacture to the sale of composite wood products, are affected by the final rule requirements.

Formaldehyde is a colorless, flammable gas at room temperature and has a strong odor. Formaldehyde can cause irritation of the skin, eyes, nose, and throat. High levels of exposure may cause some types of cancers. The primary way people can be exposed to formaldehyde is by breathing air containing off-gassed formaldehyde. Everyone is exposed to small amounts of formaldehyde in the air that has off-gassed from products, including composite wood products. Formaldehyde is found in:

• Resins used in the manufacture of composite wood products (i.e., hardwood plywood, particleboard, and medium-density fiberboard);
• Building materials and insulation;
• Household products such as glues, permanent press fabrics, paints and coatings, lacquers and finishes, and paper products;
• Preservatives used in some medicines, cosmetics, and other consumer products such as dishwashing liquids and fabric softeners; and
• Fertilizers and pesticides.

TSCA actions related to formaldehyde

The Formaldehyde Standards for Composite Wood Products Act signed into law on July 7, 2010, added Subchapter VI to the Toxic Substances Control Act (TSCA) to reduce emissions of formaldehyde from composite wood products by establishing formaldehyde emissions limits for domestic or imported hardwood plywood, particleboard, and medium-density fiberboard sold, supplied, offered for sale, or manufactured in the U.S., whether in the form of an unfinished panel or incorporated into a finished good.

Effective May 22, 2017, Environmental Protection Agency (EPA) regulation 40 CFR 770, Formaldehyde Standards Composite Wood Products, set limits on how much formaldehyde can be released from composite wood products and established a program in which independent certifying organizations will verify that composite wood panel producers comply with the limits on formaldehyde releases.

All entities along the supply chain, from the manufacture to the sale of composite wood products, are affected by the final rule requirements. This includes panel producers, fabricators, third-party certifiers, importers, distributors, retailers, and accreditation bodies. If a business is unsure if it fits into one of these categories, it may wish to refer to the table below. Examples of each category include (but are not limited to) the following:

Lead

• Title IV of TSCA, along with other authorities in the Residential Lead-Based Paint Hazard Reduction Act of 1992, requires EPA to regulate lead-based paint hazards.
• There are five main programs found in the EPA regulations at 40 CFR 745.

Lead is a naturally occurring element found in small amounts in the earth’s crust. While it has some beneficial uses, it can be toxic to humans and animals, causing negative health effects. Lead can be found in all parts of our environment – air, soil, water, and even inside our homes.

Much of our exposure comes from human activities including the use of fossil fuels like previous use of leaded gasoline, some types of industrial facilities, and previous use of lead-based paint in homes. Lead and lead compounds have been used in a wide variety of products found in and around our homes, including paint, ceramics, pipes and plumbing materials, solders, gasoline, batteries, ammunition, and cosmetics.

Lead is particularly dangerous to children because their growing bodies absorb more lead than adults do and their brains and nervous systems are more sensitive to the damaging effects of lead, including behavior and learning problems, lower intelligence quotient (IQ), hyperactivity, slowed growth, hearing problems, and anemia.

Adults may be exposed to lead by eating and drinking food or water containing lead or from dishes or glasses that contain lead. They may also breath lead dust by spending time in areas where lead-based paint is deteriorating, and during renovation or repair work that disturbs painted surfaces in older homes and buildings. Working in a job or engaging in hobbies where lead is used, such as making stained glass, can increase exposure as can certain folk remedies containing lead.

Adults exposed to lead can suffer from cardiovascular effects, increased blood pressure, and incidence of hypertension; decreased kidney function; and reproductive problems (in both men and women).

TSCA actions related to lead

Title IV of the Toxic Substances Control Act (TSCA), along with other authorities in the Residential Lead-Based Paint Hazard Reduction Act of 1992, requires the Environmental Protection Agency (EPA) to regulate lead-based paint hazards. Five main programs are found in the EPA regulations at 40 CFR 745:

Mercury

• MEBA reduces the availability of mercury in domestic and international markets.
• TSCA amendments made it unlawful to export specific mercury compounds after January 1, 2020.
• Persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, must report to EPA every three years under the Mercury Inventory Reporting Rule.

Mercury is a naturally occurring chemical element found in rock in the earth's crust, including in deposits of coal. Elemental or metallic mercury is a shiny, silver-white metal, historically referred to as quicksilver, and is liquid at room temperature. It is used in older thermometers, fluorescent light bulbs, and some electrical switches.

In its inorganic form, mercury occurs abundantly in the environment, primarily as the minerals cinnabar and metacinnabar, and as impurities in other minerals. Mercury can readily combine with chlorine, sulfur, and other elements, and subsequently weather to form inorganic salts. Mercuric chloride is used in photography and as a topical antiseptic and disinfectant, wood preservative, and fungicide. Human exposure to inorganic mercury salts can occur both in occupational and environmental settings.

Mercury exposure at high levels can harm the brain, heart, kidneys, lungs, and immune system of people of all ages. High levels of methylmercury in the bloodstream of babies developing in the womb and young children may harm their developing nervous systems, affecting their ability to think and learn.

TSCA actions related to mercury

Actions to protect the public from exposure to mercury under the Toxic Substances Control Act (TSCA) include the following:

• October 2008 Mercury Export Ban Act (MEBA; Public Law 110-414) reduces the availability of mercury in domestic and international markets. Mercury and mercury compounds may be used to manufacture chemicals and electrical equipment; although, their use has declined due in part to concerns about human health and environmental effects from exposure. Specifically, MEBA:
  • Added section 12(c) to TSCA, which prohibits the export of elemental mercury unless the Environmental Protection Agency (EPA) issues an exemption for a specified use as an “essential use” through a petition and rulemaking process, or unless the export involves coal. Essential use exemptions may not exceed three years in duration or 10 metric tons of elemental mercury and are subject to other terms and conditions specified by EPA.
  • Added section 6(f) to TSCA to make it unlawful for a federal agency to convey, sell, and distribute elemental mercury under its jurisdiction unless the transfer of elemental mercury facilitates its storage or involves coal. Prior to MEBA’s enactment, the policy of the U.S. Department of Energy (DOE) and Department of Defense (DOD) was to store, not sell, mercury stocks. MEBA codified this existing policy in TSCA and also directed DOE to establish a program for long-term management and storage of elemental mercury generated within the U.S.
• June 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) amended TSCA section 12(c) to make it unlawful to export specific mercury compounds after January 1, 2020, and to require EPA to report to Congress on the status of mercury compound exports and disposal. The LCSA amended MEBA with regard to the long-term storage of mercury. The LCSA also added section 8(b)(10) to TSCA to direct EPA to gather information regarding the supply, use, and trade of elemental mercury and mercury compounds in the U.S. and periodically publish such information in the Federal Register. In 2017, EPA published its initial report on the inventory of mercury supply, use, and trade in the U.S.
• August 2016 Prohibited Mercury Compounds List identifies five mercury compounds that EPA prohibits from export effective January 1, 2020.
• June 2018 Mercury Inventory Reporting Rule requires reporting from persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process. Reporting is done by the first of July every three years (2022, 2025, etc.) using the Mercury Electronic Reporting application. The information collected through the new reporting requirements will be used to develop future inventories of mercury supply, use, and trade in the U.S. Based on the inventory of information collected, EPA will identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use.

Methylene chloride

• The final rule under section 6 of TSCA prohibits the manufacture, processing, and distribution of methylene chloride in all paint and coating removers for consumer use, including distribution to and by retailers.
• Manufacturers, importers, processors, and distributors of methylene chloride for any use must provide downstream notification of the rule’s prohibitions (through a safety data sheet) to companies to whom methylene chloride was shipped.

Methylene chloride is a volatile chemical used in a variety of industries, such as paint and coating removal, plastic processing, metal cleaning and degreasing, adhesive manufacture, and as a heat transfer fluid.

The Environmental Protection Agency (EPA) has found risks to consumers using methylene chloride to be unreasonable due to acute human lethality. Even short-term exposures to the chemical fumes can rapidly cause dizziness, loss of consciousness, and death due to nervous system depression. EPA is particularly concerned about consumers’ risk of death from using methylene chloride in enclosed spaces, e.g., bathrooms.

TSCA actions related to methylene chloride

Actions to protect people and the environment from methylene chloride under the Toxic Substances Control Act (TSCA) are as follows:

• 2019 Consumer Ban on Paint and Coating Removal Products — On March 15, 2019, EPA issued a final rule under section 6 of TSCA to address the agency’s final determination of unreasonable risk of injury to health due to acute human lethality presented by methylene chloride in paint and coating removal for consumer use. (The final rule added regulations to 40 CFR 751.)

• The final rule prohibits the manufacture, processing, and distribution of methylene chloride in all paint and coating removers for consumer use, including distribution to and by retailers. Although EPA had proposed to regulate methylene chloride for other commercial paint and coating removal uses, the agency decided to further evaluate the risks from such uses to inform the development of an appropriate regulatory risk management approach.
• Manufacturers, importers, processors, and distributors of methylene chloride for any use must use a safety data sheet (SDS) to provide downstream notification of the rule’s prohibitions to companies to whom methylene chloride was shipped.
• The recordkeeping requirement under this final rule mandate that each person (excluding retailers of products to consumer end users) who manufactures, processes, or distributes in commerce any methylene chloride must retain in one location at the headquarters of the company, or at the facility for which the records were generated, documentation showing:

• The name, address, contact, and telephone number of companies to whom methylene chloride was shipped;
• A copy of the notification provided to companies to whom the methylene chloride was shipped; and
• The amount of methylene chloride shipped.

• This information must be retained for three years from the date of shipment.

• Managing Risks Found in the 2020 Final Risk Evaluation — EPA selected methylene chloride as one of the first 10 chemicals to undergo risk evaluation to examine risks posed by conditions of use not addressed by the 2019 rule, i.e., commercial methylene chloride in paint and coating removal, including commercial furniture refinishing.

• In June 2020, EPA released the final risk evaluation for methylene chloride, identifying unreasonable risks to workers, occupational non-users, consumers, and bystanders from methylene chloride exposure under 47 out of 53 conditions of use. EPA did not find any unreasonable risks to the environment from use of this chemical.
• The next step in the process required by TSCA is addressing these methylene chloride risks. There are several actions EPA could take to address these risks, including regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical substance, as applicable.

Persistent, bioaccumulative, and toxic (PBT) chemical substances

• LCSA includes a provision under TSCA section 6(h) requiring EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable.

Persistent, bioaccumulative, and toxic (PBT) chemicals are those that build up in the environment over time and can therefore have potential risks for exposed populations, including the general population, consumers and commercial users, and susceptible subpopulations (such as workers, subsistence fishers, tribes, and children).

TSCA actions related to PBT chemical substances

The Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), enacted on June 22, 2016, includes a provision under Toxic Substances Control Act (TSCA) section 6(h) requiring the Environmental Protection Agency (EPA) to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable.

EPA identified five PBT chemicals for expedited action in 2016, following criteria outlined in section 6(h) and issued final rules on January 6, 2021, which added regulations to 40 CFR 751 Subpart E. Pursuant to the statute, no risk evaluation was required for these chemicals:

• Decabromodiphenyl ether (DecaBDE)
• Phenol, isopropylated phosphate (3:1) (PIP (3:1))
• 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
• Hexachlorobutadiene (HCBD)
• Pentachlorothiophenol (PCTP)

However, in September 2021, EPA announced its intent to initiate a new rulemaking and anticipates proposing new rules for all five of the above PBT chemicals that are the subject of final risk management rules under TSCA. EPA explains that it is considering revising all five of the final rules to further reduce exposures, promote environmental justice, and better protect human health and the environment. EPA plans to issue a proposal for a new separate rulemaking on the five PBT chemicals in the spring of 2023.

Additionally, EPA took a separate final action on September 17, 2021, to extend the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirement of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)) until March 8, 2022. This final rule is effective upon publication.

In October 2021, EPA proposed a rule to further extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA also provided a description of the specific kinds of information the agency will require to support any additional extensions to the compliance dates.

Per- and polyfluoroalkyl substances (PFAS)

• EPA has taken a range of regulatory actions to address PFAS substances in manufacturing and consumer products.

Per- and polyfluoroalkyl substances (PFAS) are a group of human-made chemicals that have been manufactured and used in a variety of industries since the 1940s. PFAS include perfluorooctanoic acid (PFOA), perfluorooctyl sulfonate (PFOS), and many other chemicals.

PFAS are found in a wide range of consumer products that people use daily such as cookware, pizza boxes, and stain repellants. Most people have been exposed to PFAS, and certain PFAS can accumulate and stay in the human body for long periods of time. There is evidence that exposure to PFAS can lead to adverse health outcomes in humans. The most consistent findings from human epidemiology studies are increased cholesterol levels among exposed populations, with more limited findings related to infant birth weights, effects on the immune system, cancer, and thyroid hormone disruption.

TSCA actions related to PFAS

The Environmental Protection Agency (EPA) has taken a range of regulatory actions to address PFAS substances in manufacturing and consumer products as noted below:

• On March 11, 2002, and December 9, 2002, EPA published two significant new use rules (SNURs) to require notification to EPA before any future manufacture (including import) of 88 PFAS chemicals specifically included in the voluntary phase out of PFOS by a chemical company that took place between 2000 and 2002. This SNUR allowed the continuation of a few specifically limited, highly technical uses of these chemicals for which no alternatives were available, and which were characterized by very low volume, low exposure, and low releases. Any other uses of these chemicals would require prior notice to and review by the agency.
• In 2006, EPA invited eight major leading companies in the PFAS industry to join in a global stewardship program.
• On October 9, 2007, EPA finalized a SNUR on 183 PFAS chemicals believed to no longer be manufactured (including imported) or used in the U.S.
• On October 22, 2013, EPA issued a rule requiring companies to report all new uses of certain PFOA-related chemicals as part of carpets, a category of potentially harmful chemicals once used on carpets to impart soil, water, and stain resistance. Companies must now report to EPA their intent to manufacture (including import) these chemical substances intended for use as part of carpets or to treat carpets, as well as import carpets already containing these chemical substances.
• On January 21, 2015, EPA proposed a SNUR to require manufacturers (including importers) of PFOA and PFOA-related chemicals, including as part of articles, and processors of these chemicals to notify EPA at least 90 days before starting or resuming new uses of these chemicals in any products. This notification would allow EPA the opportunity to evaluate the new use and, if necessary, take action to prohibit or limit the activity.
• On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) significantly amended the Toxic Substances Control Act (TSCA). EPA has issued rules to provide a framework for the implementation of the amended law. The framework rules outline EPA’s path forward for prioritizing, evaluating, and regulating chemicals. It also included a requirement for industry reporting of chemicals manufactured (including imported) or processed in the U.S. over the previous 10 years. (EPA issued this TSCA Inventory Notification (Active-Inactive) rule (also called the Inventory Reset rule) on August 11, 2017.) With regard to PFAS, this reporting will be used to identify which chemical substances are active in U.S. commerce and will help inform the prioritization of chemicals, such as PFAS, for risk evaluation.
• On February 20, 2020, EPA proposed a supplemental SNUR to ensure EPA is notified before anyone begins or resumes the import of long-chain PFAS chemical substances as part of surface coatings on articles.
• In July 2020, EPA issued a final rule strengthening the regulation of PFAS by requiring notice and EPA review before the use of long-chain PFAS that have been phased out in the U.S. could begin again. Additionally, products containing certain long-chain PFAS as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances can no longer be imported into the U.S. without EPA review. This action means that articles like textiles, carpet, furniture, electronics, and household appliances that could contain certain PFAS chemicals cannot be imported into the U.S. unless EPA reviews and approves the use or puts in place the necessary restrictions to address any unreasonable risks.
• In June 2021, EPA withdrew a compliance guide related to EPA’s?July 2020 SNUR on certain long-chain PFAS. The withdrawn compliance guide, which was issued in January 2021, addressed whether certain imported articles were covered by the SNUR. EPA determined the compliance guide inappropriately narrowed the scope and weakened the SNUR. EPA’s?July 2020 SNUR continues to be in effect. Articles containing certain long-chain PFAS as a surface coating cannot be imported into the U.S. without EPA review. Importers of articles, but not processors of articles are subject to the SNUR.
• On June 28, 2021, EPA proposed reporting and recordkeeping requirements for PFAS under TSCA section 8(a). In accordance with obligations under TSCA, as amended by the National Defense Authorization Act for Fiscal Year 2020, EPA proposed to require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards. The law mandates that EPA issue this data call no later than January 1, 2023. These data will enable EPA to better characterize the sources and quantities of manufactured PFAS in the U.S.
• On October 18, 2021, EPA announced the agency’s comprehensive PFAS Strategic Roadmap: EPA Commitments to Action 2021-2024, which goes over the agency’s approach to confronting PFAS contamination nationwide. Among the strategies, the roadmap calls for:
  • A robust review process for new PFAS under TSCA to ensure these substances are safe before they enter commerce;
  • A review of existing PFAS under TSCA to: ensure existing PFAS are being used in ways that do not present concerns, and prevent resumed production of legacy PFAS or their use in new ways; and
  • Finalize new PFAS reporting under TSCA Section 8 to better characterize the sources and quantities of manufactured PFAS in the U.S.
  • Actions from not just EPA’s Office of Chemical Safety and Pollution Prevention but also from the Office of Water, Office of Land and Emergency Management, Office of Air and Radiation, and Office of Research and Development.
• In October 2021, EPA issued the National PFAS Testing Strategy that will help EPA identify and select PFAS for which the agency will require testing using TSCA authorities. EPA’s initial set of test orders for PFAS will be strategically selected from more than 20 different categories of PFAS.

Polychlorinated biphenyls (PCBs)

• TSCA and the PCB regulations are designed to ban the manufacture of PCBs and ensure the proper disposal of PCBs and PCB Items, while minimizing the risk posed by the storage, use, and handling of the substance.
• The PCB regulations apply to any substance, mixture, or item with a concentration of 50 ppm PCBs or greater or with a concentration below 50 ppm that resulted from dilution.

Polychlorinated biphenyls (PCBs) belong to a broad family of human-made organic chemicals known as chlorinated hydrocarbons. They have no known taste or smell, and range in consistency from an oil to a waxy solid. This chemical has been shown to cause cancer in animals as well as a number of serious non-cancer health effects in animals, including effects on the immune system, reproductive system, nervous system, endocrine system and other health effects. Moreover, PCBs persist and when released into the environment tend to accumulate in tissues of living organisms.

PCBs were domestically manufactured from 1929 until manufacturing was banned in 1979. They have a range of toxicity and vary in consistency from thin, light-colored liquids to yellow or black waxy solids. Due to their non-flammability, chemical stability, high boiling point and electrical insulating properties, PCBs were used in hundreds of industrial and commercial applications including:

• Electrical, heat transfer, and hydraulic equipment;
• Plasticizers in paints, plastics, and rubber products;
• Pigments, dyes, and carbonless copy paper; and
• Other industrial applications.

TSCA actions related to PCBs

The Toxic Substances Control Act (TSCA) of 1976 provides the Environmental Protection Agency (EPA) with authority to require reporting, recordkeeping, and testing requirements and restrictions relating to chemical substances and/or mixtures, including PCBs. TSCA addresses the production, importation, use, and disposal of specific chemicals including PCBs.

Current PCB regulations, published pursuant to the TSCA section 6(e), can be found at 40 CFR 761, which has been in place since 1979. In general, TSCA and the PCB regulations are designed to ban the manufacture of PCBs and ensure the proper disposal of PCBs and PCB Items, while minimizing the risk posed by the storage, use, and handling of the substance.

The PCB regulations apply to any substance, mixture, or item with a concentration of 50 parts per million (ppm) PCBs or greater or with a concentration below 50 ppm that resulted from dilution. There are certain exceptions, however. For example, the regulations restrict the marketing and burning of used oil containing any quantifiable PCB level (2 ppm) and prohibit the use of waste oil that contains any detectible concentration of PCBs as a sealant, coating, or dust control agent.

Some of the major provisions of the PCB regulations at 40 CFR 761 include:

• General (Subpart A) — In addition to identifying who is regulated, establishing definitions, and listing reference documents, this subpart prescribes the assumed PCB concentrations, for regulatory purposes, of various articles (such as oil filled capacitors) for which the actual PCB concentration is unknown.
• Prohibitions/Authorizations (Subpart B) — There are numerous prohibitions on the use of PCBs or PCB items in a manner other than in a totally enclosed manner; on the manufacture of PCBs for use within the U.S. or for export; and on the processing and distribution of PCBs and PCB items for use within the U.S. or for export. However, the regulations also establish numerous exceptions and authorized activities (e.g., where "non-totally enclosed" activities may be conducted). Such authorizations pertain to the use of PCBs and servicing of PCBs in various PCB equipment, such as transformers, capacitors, natural gas pipelines, and hydraulic systems; the manufacturing of certain products with inadvertent, low-concentration production of PCBs; and the use of sewage sludge with PCBs where such sludge use is regulated by other parts of 40 CFR. Owners of PCB transformers must register the transformers with EPA. Owners of PCB articles may store them for reuse subject to storage area specifications, maximum storage periods, and/or recordkeeping requirements.
• Marking (Subpart C) — Specified items including PCB equipment (e.g., heat transfer systems using PCBs, PCB large low voltage capacitors, and storage areas used to store PCBs/PCB Items) must bear markings warning of PCBs in accordance with prescribed formats. The regulation does not require PCB-contaminated electrical equipment to be marked.
• Storage and disposal (Subpart D) — Regulations govern storage (for reuse or disposal) and disposal of PCBs, PCB waste, and PCB Items, including PCB articles (e.g., transformers, capacitors, and hydraulic machines) and PCB containers. The subpart includes separate sections that set out disposal requirements and allowed disposal methods for PCB remediation waste, PCB bulk product waste, and PCB waste from research and development activities. The regulations exempt PCB household waste from regulatory requirements. The regulations also set out requirements applicable to PCB waste and PCB items in storage for disposal and decontamination of various surfaces. Further regulatory sections specify requirements for each disposal method. PCB disposal and PCB commercial storage facilities must obtain written final approval to operate facilities.
• Exemptions (Subpart E) — This subpart grants exemptions to specific companies or groups of companies for the manufacture, processing, and distribution in commerce of PCBs for specified purposes, including microscopy, research and development, and laboratory sampling and analysis.
• Transboundary shipments of PCBs for disposal (Subpart F) — EPA prohibits the importation of PCBs for disposal without an exemption issued under the authority of TSCA section 6(e)(3). EPA prohibits the exportation of PCBs for disposal at concentrations greater than or equal to 50 ppm. Shipments that leave the U.S. only as part of their transit from one part of the U.S. to another are not considered exports or imports. Shipments passing through from Canada to Mexico or vice versa are not considered exports or imports.
• Recordkeeping/Reporting (Subpart J) — Owners and operators of facilities with PCBs and PCB items in service or projected for disposal, commercial storage facilities of PCB waste, incineration facilities, chemical waste landfill facilities, high efficiency boiler facilities, importers, facilities generating PCBs in excluded manufacturing processes, and facilities that manufacture, import, process, distribute in commerce, or use chemicals containing inadvertently generated PCBs must comply with recordkeeping and reporting requirements. Some types of data for which records may be required to be kept include PCB weights; the identification and numbers of items; storage, transfer, and disposal dates; and the identification of shippers and receivers.
• PCB waste disposal records and reports (Subpart K) — Some generators and all transporters, storers, and disposers of PCB wastes must notify EPA that they are engaging in such activity and obtain an identification number from EPA. When a PCB waste generator sends such wastes offsite, the generator, transporter, and disposer must prepare and maintain manifests identifying the waste and tracking the dates and parties involved in the disposal process. The disposal facility must prepare a Certificate of Disposal and send it to the generator identified on the manifest. The subpart also includes recordkeeping requirements and procedures for cases in which manifests or Certificate of Disposal are not prepared by one of the parties in a transaction. Note that EPA issued this direct final rule on September 6, 2012, to update and clarify several sections of the PCB regulations at 40 CFR 761 associated with manifesting requirements.
• Sampling and decontamination procedures for wastes and surfaces (Subparts M through T) — These subparts set out recommended procedures for sampling PCBs in various wastes and surfaces, including sample site and size selection, sample collection, analytical requirements, and interpretation of results. The regulations also set out a method for decontaminating non-porous surfaces and requirements for studies of new decontamination solvents.

Determining if a chemical is subject to a SNUR

• If a facility’s chemical substance is subject to a SNUR and the facility’s intended manufacture, processing, or use of the substance is a significant new use, the facility would be required to submit a SNUN 90 days prior to the manufacture of that substance.

To facilitate determining whether a substance is subject to a significant new use rule (SNUR), substances on the Toxic Substances Control Act (TSCA) Inventory that are subject to SNUR requirements are designated as such by an "S" flag in the Inventory listing. If a facility’s chemical substance is subject to a SNUR and the facility’s intended manufacture, processing, or use of the substance is a significant new use, the facility would be required to submit a significant new use notice (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 Inventory. Because the chemical identities of the chemical substances can be claimed to be Confidential Business Information (CBI), the Environmental Protection Agency (EPA) maintains a CBI version of the TSCA Inventory. If an intended manufacturer submits a premanufacture notice or a notice of bona fide intent to manufacture (pursuant to the procedures at 40 CFR 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.

SNUN filing and exemptions

• Receipt of a SNUN triggers EPA review of the risks associated with the SNUN and a determination of whether such risks warrant control.
• SNUNs are reported using the standard e-PMN form and are subject to a 90-day review process similar to that for a PMN.

If the Environmental Protection Agency (EPA) promulgates a significant new use rule (SNUR) under 40 CFR 721, the Toxic Substances Control Act (TSCA) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the substance for that use. Information submitted in a SNUN must include, insofar as it is known to or reasonably ascertainable by the submitter, information described in TSCA section 8(a)(2) (i.e., chemical identity, use, and exposure data), as well as test data, and descriptions of other data related to the effects on health and the environment of the manufacture, processing, use, distribution in commerce, and disposal of the chemical substance (TSCA section 5(d)).

Receipt of a SNUN triggers EPA review of the risks associated with the SNUN and a determination of whether such risks warrant control. EPA reviews specific significant new uses proposed in a SNUN on a case-by-case basis before such uses of the chemical enter commerce. The notification gives EPA the opportunity to evaluate the new use and:

• Make an affirmative determination on the safety of the significant new use; or
• Take action to prohibit or limit the activity to address any unreasonable risks identified.

EPA review of a SNUN puts the agency in the position of reviewing the risks of specific significant new uses only when introduction into commerce is imminent.

EPA recommends that submitters consult with the agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance.

Joint SNUN submissions

Potential SNUN submitters should be aware of 40 CFR 721.25(b), which authorizes joint SNUNs by two or more persons -- for example, a manufacturer and several processors. In many cases, EPA will need to respond to a SNUN by amending the SNUR to allow companies other than the SNUN submitter (such as the submitter's processor customers) to engage in the newly approved use(s). Note that before EPA amends the SNUR, even after a manufacturer submits a SNUN and the review period expires, processors (and other manufacturers) of the substance are still legally required to submit their own SNUN before engaging in the significant new use.

Electronic submission

SNUNs are reported using the standard e-PMN form and are subject to a 90-day review process similar to that for a premanufacture notice (PMN). When submitting a SNUN, the submitter should include a cover letter that provides the Code of Federal Regulations citation of the SNUR and identifies the specific significant new use(s) for which the SNUN is being submitted.

Exemptions

Under TSCA section 5(h), EPA may exempt a chemical manufacturer or processor from submitting a SNUN when the agency determines that the use of a chemical substance would not pose an unreasonable risk, or when the agency already has information about the chemical substance. In some circumstances, EPA may not grant an exemption unless an entity applies for one. For exemptions that require an application, EPA must grant or deny the exemption within 45 days of receiving the application.

Regulation of significant new uses

• If EPA issues a proposed rule under TSCA section 5(f), the requirements in the proposed rule become effective upon its publication in the Federal Register.

If the Environmental Protection Agency (EPA) finds that a significant new use of a chemical substance subject to a significant new use notice (SNUN) presents an unreasonable risk, section 5(f) of the Toxic Substances Control Act (TSCA) directs the agency to either:

• Propose a rule imposing one or more of the requirements specified in section 6(a) to the extent necessary to protect against such risk, or
• Issue an order to prohibit or limit the manufacture, processing, or distribution of the chemical.

If EPA issues a proposed rule under section 5(f), the requirements in the proposed rule become effective upon its publication in the Federal Register, and EPA must, as expeditiously as possible, either finalize the rule (with or without modification) or revoke it. An issued order becomes effective at the end of the review period, which is 90 days unless extended to 180 days with good cause.

If EPA finds that available information is insufficient to evaluate risks of a new chemical substance or significant new use, section 5(e) requires EPA to issue an administrative order to prohibit or otherwise restrict manufacture, processing, distribution, use, or disposal to the extent necessary to protect against unreasonable risks pending the development of further information. An issued order becomes effective at the end of the review period. The submitter of the SNUN must comply with the order while the required information is being developed. For significant new uses for which information is insufficient to evaluate risks while section 5(e) orders apply to the SNUN submitter, EPA may in practice also promulgate a significant new use rule (SNUR) to apply the restrictions outlined in an order to other manufacturers and processors.

For substances subject to SNUN restrictions that EPA subsequently finds are not likely to present unreasonable risk; the submitter of the notice may commence manufacture of the substance for the uses described in the notice after the agency publishes a statement of its finding.

Orders related to importing

TSCA section 5(e) orders may include restrictions on the amount of the chemical allowed to be manufactured (including imported), as well as other restrictions. (The import/production limits often serve as triggers for toxicity or related testing requirements.) To comply with these requirements when applicable, chemical substances must:

• Not be imported for any prohibited use;
• Satisfy all applicable labeling and safety data requirements;
• Not exceed any specified restrictions on permissible import volume;
• Not be imported for any designated significant new use; and
• Comply with any other applicable requirements.

Preliminary assessment information rule (PAIR)

• Under PAIR, producers and importers of a listed chemical are required to report certain site-specific information.

Under TSCA, which covers the production, distribution, use, and disposal of chemical substances, EPA’s Office of Pollution Prevention and Toxics is charged with the responsibility for assuring that chemicals made available for sale and use in the U.S. do not pose any unreasonable adverse risks to human health or to the environment. To carry out this mandate, EPA has broad authority to issue regulations designed to gather health/safety and exposure information on, require testing of, and control exposure to chemical substances and mixtures.

TSCA section 8(a) requirements

TSCA section 8(a), Reporting and Retention of Information, gives EPA the authority to promulgate rules under which manufacturers (which by statute includes importers) and processors of chemical substances must maintain records and/or report such data as EPA may reasonably require in order to carry out the TSCA mandates. Examples of information that can be required to be reported under TSCA section 8(a) include:

• Chemical or mixture identity;
• Categories of use;
• Quantity manufactured or processed;
• By-product description;
• Health and environmental effects information;
• Number of individuals exposed; and
• Method(s) of disposal.

Section 8(a) regulations can be tailored to meet unique information needs (e.g., via chemical-specific rules) or information can be obtained via the use of “model” or standardized reporting rules.

Preliminary Assessment Information Rule (PAIR)

The PAIR requirements at 40 CFR 712 is one example of a model TSCA section 8(a) reporting rule. Under PAIR, producers and importers of a listed chemical are required to report the following site-specific information:

• Quantity of chemical produced and/or imported;
• Amount of chemical lost to the environment during production or importation;
• Quantity of enclosed, controlled, and open releases of the chemical; and
• Per release, the number of workers exposed and the number of hours exposed.

Respondents are only required to report information that is known or reasonably ascertainable by them. Extensive file searches are not required. The PAIR reporting requirements are included in the PAIR form (EPA Form 7710-35) and instructions.

Exemptions for such reporting are as follows:

• Production or importation for the sole purpose of research and development;
• Production or importation of less than 500 kilograms during the reporting period at a single plant site;
• Companies whose total annual sales from all sites owned by the domestic or foreign parent company are below $30 million for the reporting period and who produced or imported less than 45,400 kilograms of the chemical; and
• Production or importation of the listed chemical solely as an impurity, a non-isolated intermediate, and under certain circumstances as a by-product.

EPA uses PAIR to collect information to help identify, assess, and manage human health and environmental risks caused by the manufacture or importation of identified chemical substances, mixtures, and categories. PAIR is also available to EPA for the purpose of informing the prioritization and risk evaluation activities.

EPA or other federal agencies (e.g., the agencies that are part of the Interagency Testing Committee (ITC) as authorized under TSCA section 4(e)) can identify chemicals for a TSCA section 8(a) PAIR expediated rulemaking that have a justifiable need for production, use, or exposure-related data.

Substantial risk notice

• EPA’s guidance states that Substantial Risk Notifications under TSCA section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.
• EPA allows commercial establishments to assume responsibility for submitting substantial risk information obtained by individual employees and officials.
• The FYI classification was created by EPA to capture chemical risk submissions by persons or organizations not subject to the TSCA section 8(e) reporting requirements.

Section 8(e) of the Toxic Substances Control Act (TSCA) requires U.S. chemical manufacturers (including importers), processors, and distributors to notify the Environmental Protection Agency (EPA) immediately of information that reasonably supports the conclusion that their substances or mixtures present a substantial risk of injury to health or the environment. EPA’s guidance states that Substantial Risk Notifications under TSCA section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.

Section 8(e) continues to be an important and useful tool for early warning and identification of potential substantial risk situations allowing EPA and others to focus their limited resources on chemicals or mixtures of highest concern. The submission of section 8(e) information makes it possible for the agency and others to learn quickly about potential new chemical hazards/risks posed by exposure to chemical substances, to conduct more complete assessments and, if needed, to take effective action to eliminate or reduce such risks in a timely manner.

Specifically, section 8(e) of TSCA states, “any person who manufactures, [imports,] processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.”

What is substantial risk?

EPA’s TSCA section 8(e) guidance (in the June 3, 2003, Federal Register 68 FR 33129) states that a "substantial risk of injury to health or the environment" is:

• A risk of considerable concern because of the seriousness of the effect, and
• The fact or probability of its occurrence.

These two criteria are differentially weighted for different types of effects. Certain human health effects are so serious that relatively little weight is given to exposure. The mere fact that the implicated chemical is in commerce constitutes sufficient evidence of exposure. In contrast, the remaining human health effects as well as environmental effects must involve or be accompanied by the potential for significant levels of exposure.

Who is required to report?

Section 8(e) of TSCA requires manufacturers (including importers), processors, and distributors of chemicals to notify the EPA immediately of information that reasonably supports the conclusion that their substances or mixtures present a substantial risk of injury to health of the environment. TSCA section 8(e) does not provide exemptions for small businesses, small production or importation volumes, or commercial activities such as manufacture for export only or research and development.

EPA allows commercial establishments to assume responsibility for submitting substantial risk information obtained by individual employees and officials. EPA's TSCA section 8(e) policy statement explains that individual officers/employees are viewed as having discharged their individual TSCA section 8(e) responsibilities once they notify a designated supervisor or official in full about pertinent information, provided the employing entity has an established, internally publicized and affirmatively implemented procedure governing such Substantial Risk Notifications. The agency's TSCA section 8(e) policy statement specifies that such procedures, at a minimum, must:

• Specify the information that must be reported;
• Indicate how the reports are to be prepared and submitted internally;
• Note the federal, civil, and criminal penalties for failure to report substantial risk information; and
• Provide a mechanism for the timely notification of officers and employees who submitted reports about the disposition of those reports. Such notification should inform the reporting employee/officer as to whether or not the information was submitted to EPA, and if not, inform the employee or officer of their protected right (under TSCA section 23) to report the information directly to EPA.

It is important to note that those employees and officers who are responsible for actual management of the organization's TSCA section 8(e) reporting obligations retain personal, civil, and/or criminal liability for ensuring that substantial risk information is submitted to EPA. In the absence of established internal procedures, all employees and officers retain their individual responsibilities and liabilities for ensuring that substantial risk information is reported to the agency.

It should be noted that trade associations and industry consortia can submit substantial risk notification on behalf of member companies covered under the reporting requirement.

Voluntary submissions

EPA welcomes human health and environmental risk-related information submitted by persons not covered by the TSCA section 8(e) reporting requirement. The agency established a classification system to distinguish voluntary “For Your Information” (FYI) submissions from Substantial Risk Notifications submitted formally to EPA under TSCA section 8(e), discussed above. The FYI classification was created by EPA to capture chemical risk submissions by persons or organizations not subject to the TSCA section 8(e) reporting requirements.

Sometimes FYIs are also submitted when a manufacturer, importer, or processor is not sure its information supports a conclusion of substantial risk. Often, they are submitted when a person or company not required to submit, nevertheless, would like to bring risk information on a chemical to EPA’s attention. Chemical companies, trade associations, public interest groups, and academic institutions are among those who submit FYIs.

Health and safety studies and data reporting

• Manufacturers and processors of the chemical substances and mixtures subject to a TSCA section 8(d) rulemaking must submit lists and copies of health and safety studies relating to the health and/or environmental effects of the chemical substances and mixtures.
• All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of CBI.
• EPA will make non-confidential versions of the health and safety studies available via its publicly available ChemView online database.

Toxic Substances Control Act (TSCA) section 8(d) authorizes the Environmental Protection Agency (EPA) to promulgate rules requiring certain persons who manufacture, process, or distribute in commerce (or propose to manufacture, process, or distribute in commerce) chemical substances and mixtures, to submit to EPA lists and copies of health and safety studies in their possession with respect to such chemical substances and mixtures.

Health and safety study is intended to be interpreted broadly and means "any study of any effect of a chemical substance or mixture on health or the environment or on both," including but not limited to:

• Epidemiological or clinical studies,
• Studies of occupational exposure,
• In vivo and in vitro toxicological studies, and
• Ecotoxicological studies.

Data items

These rules, which are codified in 40 CFR 716, require the manufacturers and processors of the chemical substances and mixtures subject to a TSCA section 8(d) rulemaking to submit lists and copies of health and safety studies relating to the health and/or environmental effects of the chemical substances and mixtures. All submitted studies must be accompanied by a cover letter that contains the following data:

• Name,
• Job title,
• Address,
• Telephone numbers of the submitting official,
• Name and address of the manufacturing or processing establishment on whose behalf the submission was made,
• Identity of any impurity or additive known to have been present in the substance or listed mixtures as studied, unless so noted in the study.
• Indication that the study is being submitted under Part 716.

List of studies shall include:

• Ongoing health and safety studies conducted by or initiated by respondents — For these studies, the list should include the following data: beginning date of the study, purpose of the study, types of data to be collected, anticipated date of completion, and name and address of the laboratory conducting the study.
• Studies respondents know about but do not have copies of — For these studies, the list should include the name and address of a person known to them that possess a copy of the study.
• Studies that have been sent to another federal agency with no claims of confidentiality — For these studies, the list should include the following data: title of the study, name and address of the person to whom the study was sent, and month and year in which the study was submitted.

Compliance steps

EPA amends the list of subject chemicals in 40 CFR 716 periodically to add chemical substances and mixtures. The listed chemical substances and mixtures include chemicals recommended for testing under TSCA section 4 by the Interagency Testing Committee (ITC) and other chemical substances that EPA, or other federal agencies, choose to assess for health or environmental effects.

Reporting of information is only required when the subject matter information is available. Availability of study reports on the list may occur after the established reporting period for the list and must still be submitted when they become available. Studies previously submitted to EPA are exempt.

To comply, respondents must search their records to identify any health and safety studies in their possession, copy and process relevant studies, list studies that are currently in progress, and submit this information to EPA. Specifically, a representative respondent would engage in the following activities in order to produce the lists of studies and required data:

1. Determine whether the firm may be required to report. If so, review the rule in more detail;
2. Conduct a corporate review to identify which firm sites must be searched to locate the appropriate health and safety studies;
3. Search the files at appropriate sites to locate relevant studies;
4. Compile and transcribe lists of studies being submitted, ongoing studies, newly initiated studies, studies known to exist but not known to be in the respondent’s possession, and studies previously submitted to other federal agencies without confidentiality claims;
5. Photocopy or prepare electronic versions of the studies;
6. Voluntarily prepare robust summaries of the studies;
7. Review the responses for possible confidential business information and prepare information to substantiate a claim of confidentiality; and
8. Submit the studies to EPA electronically, and, after initial study submissions, notify EPA when other studies are initiated; submit studies completed after the reporting period.

Reporting is mandatory. However, respondents may claim all or part of a response confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR 2.

What happens to the submitted data?

All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of confidential business information (CBI).

Copies of the documents will then be prepared and distributed, based on the associated chemical identity, to program offices at EPA and/or to other federal agencies for scientific analysis. A coding form will be completed to capture certain descriptive information such as identity, document control number, confidentiality indicator, document title, document date, receipt date, and chemical identity. The document will be stored electronically for archival purposes. In addition, EPA will make non-confidential versions of the health and safety studies available via its publicly available ChemView online database.

EPA uses this information to support its investigation of the risks posed by the chemical substance in question and construct a complete picture of the known effects of the chemical substance. This will support the agency’s decisions on whether to require additional test data be submitted under TSCA section 4.

Significant adverse reaction

• TSCA section 8(c) requires that allegations of adverse reactions caused by any chemical substance or mixture to the health of employees be kept for 30 years, and all other allegations be kept for five years.
• Respondents subject to 40 CFR 717 must submit copies of allegation records when required by the EPA.
• Firms subject to 40 CFR 717 must keep their TSCA section 8(c) records at company headquarters or at a site central to their chemical operations.

Toxic Substances Control Act (TSCA) section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years.

The Environmental Protection Agency (EPA) promulgated 40 CFR 717, on August 22, 1983. The regulation requires manufacturers (including importers) and processors of chemical substances and mixtures to keep records of “significant adverse reactions” alleged to have been caused by such substances or mixtures. The rule also prescribes the conditions under which a firm must submit or make records available to a duly designated representative of EPA.

Required records

Records maintained pursuant to 40 CFR 717 must consist of the following:

• The original allegation as received.
• An abstract of the allegation and other pertinent information as follows: o The name and address of the plant site that received the allegation.
  • The date the allegation was received at that site.
  • The implicated substance, mixture, article, company process or operation, or site discharge.
  • A description of the alleger (e.g., employee or neighbor), including age and sex, if ascertainable.
  • A description of the health effects, including explanation of how the effects became known and the route of exposure, if explained in the allegation.
• The results of any self-initiated investigation with respect to an allegation. (EPA does not require such investigation under TSCA section 8(c).)
• Copies of any further required records relating to the allegation, e.g., records required under the Occupational Safety and Health Administration (OSHA).

Required compliance activities

Respondents subject to 40 CFR 717 must:

• Maintain records of allegations of significant adverse reactions — Entities subject to the rule must record significant reactions alleged to have been caused by substances or mixtures that they manufacture, import, or process. These firms must establish a recordkeeping system for such allegations and monitor incoming complaints to determine if they meet the criteria for filing. Allegations that are filed must be retained for 30 years if they are employee-related and for five years for all other types/sources of allegations.
• Submit copies of these allegation records when required by EPA — EPA will notify those responsible for reporting by letter or will announce any such requirements by notice in the Federal Register.

Firms subject to 40 CFR 717 must:

• Keep their TSCA section 8(c) records at company headquarters or at a site central to their chemical operations — A multi-site company will usually require the responsible official at the individual plant site to forward potentially recordable TSCA section 8(c) allegations to a designated TSCA coordinator at their operations headquarters. Depending on the size of the company, such allegations will be reviewed by a committee to determine if the allegations relate to the company’s product, operations, or discharges. If so, the effects cited in the allegation are compared against the rule’s definition and examples of “significant adverse reaction.” If the allegation meets this test, it is recorded. The actual allegation record is to be comprised of an abstract of the allegation along with a record of any company-initiated investigation and other pertinent documents. The rule does not require further investigation. EPA requires that allegations be filed so that they may be readily retrievable by the alleged “cause” of the reaction. EPA does not, however, require a specific form under this rule.
• Maintain an awareness of their reporting requirements — A reporting requirement will take the form of a letter directed to selected respondents or it will be a notice in the Federal Register. Respondents are responsible for monitoring the Federal Register for such notices. Whenever feasible, EPA will also notify those companies that can be identified with the production, importation, or processing of a substance or mixture in question. Respondents then must determine if they manufacture or process the chemical substance or mixture. If so, they must conduct a search of their TSCA section 8(c) files to determine if there are any relevant records of significant adverse reactions alleged to have been caused by the substance or mixture. If such records are present, they must make a photocopy of those records and mail the set of records with a cover letter to EPA. The company should note that they have submitted such records to EPA so that future duplicative reporting will not occur.

Chemical data reporting (CDR)

• The CDR regulation requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce.
• Information is collected every four years from manufacturers (including importers) of certain chemicals in commerce generally when production volumes for the chemical are 25,000 pounds or greater for a specific reporting year.

Chemical Data Reporting (CDR) data collection provides chemical manufacture, processing, and use information that helps the Environmental Protection Agency (EPA) identify what chemicals, from those listed on the Toxic Substances Control Act (TSCA) Inventory, the public may be exposed to as consumers or in commercial and industrial settings. The data also help EPA assess routes of potential exposure to those chemicals.

Overview

The CDR regulation at 40 CFR 711, as authorized by section 8(a) of TSCA, requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce. The CDR rule was formerly known as the Inventory Update Rule (IUR).

Under Part 711, EPA collects basic exposure-related information including information on the types, quantities and uses of chemical substances produced domestically and imported into the U.S. The CDR database constitutes the most comprehensive source of basic screening-level, exposure-related information on chemicals available to EPA and is used to protect the public from potential chemical risks.

The information is collected every four years from manufacturers (including importers) of certain chemicals in commerce generally when production volumes for the chemical are 25,000 pounds or greater for a specific reporting year. However, a reduced reporting threshold (2,500 pounds) applies to chemical substances subject to certain TSCA actions. Collecting the information every four years assures that EPA and (for non-confidential data) the public have access to up-to-date information on chemicals.

How does EPA use CDR data?

EPA uses CDR data to support risk screening, risk assessment, chemical prioritization, risk evaluation, and risk management activities, among other activities. This information allows EPA to develop an understanding of the types, amount, end uses, and possible exposure to chemicals in commerce.

The data include information on the manufacture (including import), industrial processing and use, and consumer and commercial use of certain chemicals currently listed on the TSCA Inventory, a list of chemicals that are manufactured (including imported) or processed in the U.S. Processing and use information helps EPA screen and prioritize chemicals for the purpose of identifying potential human health and environmental effects.

Importing specific chemicals and imminent hazards

• The 1989 Partial Ban prohibits import of some asbestos-containing products.
• TSCA prohibits import of PCBs.

Importing specific chemicals

Section 6 of the Toxic Substances Control Act (TSCA) contains import requirements applicable to some specific chemicals:

• PCBs — Section 6(e) of TSCA prohibits import of polychlorinated biphenyls (PCBs). See 40 CFR Part 761 for regulations on the import of PCBs. In certain limited circumstances, the Environmental Protection Agency (EPA) may grant exemptions to allow import of PCBs provided statutory and regulatory requirements are met.
• Asbestos — The 1989 Partial Ban prohibits import of some asbestos-containing products, including corrugated paper, rollboard, commercial paper, specialty paper, and flooring felt. EPA also banned new uses of asbestos which prevent new asbestos products from entering the marketplace after August 25, 1989.
• Formaldehyde — The TSCA Title VI import certification requirement applies to composite wood products (i.e., panels of hardwood plywood, particleboard, medium density fiberboard, and thin-medium density fiberboard), component parts containing such composite wood products, and finished goods containing such composite wood products that are imported into the U.S. beginning March 22, 2019. Under TSCA Title VI, importers must also take reasonable precautions by retaining, for three years, bills of lading, invoices, or comparable documents that include a written statement from the supplier that the composite wood products (or component parts/finished goods) are TSCA Title VI compliant. When EPA requests, the importer must make available within 30 days records identifying (1) the panel producer and the date the composite wood products were produced; and (2) records identifying the supplier, if different, and the date the composite wood products (or component parts/finished goods) were purchased. Refer to 40 CFR 770.

In addition to the chemicals listed above, import requirements apply to the following two types of chemicals covered by TSCA section 6 regulations:

• Certain chemical substances that may be used in metalworking fluids and that are regulated under 40 CFR 747; and
• Certain hexavalent-chromium-based water treatment chemicals that are regulated under 40 CFR 749.68.

Imminent hazards

Because imports are required to comply with any judicial orders that may be issued under section 7 of TSCA, importers need to be aware of section 7 requirements. Section 7 authorizes EPA to commence a judicial action for seizure of a chemical substance, mixture, or article containing such a chemical substance or mixture, which EPA has determined is imminently hazardous, and/or for other relief against any person who manufactures (imports), processes, distributes in commerce, uses, or disposes of an imminently hazardous chemical substance or mixture or any article containing such a substance or mixture.

Importing new chemicals and uses

• Because imports are included in the definition of manufacture, importing chemical substances can trigger premanufacture notices, significant new use notices, and other requirements.

Section 3 of the Toxic Substances Control Act (TSCA) defines the term manufacture to include import. This means that the section 5(a)(1)(B) requirement to submit a premanufacture notice (PMN) to EPA at least 90-days before commencing non-exempt commercial manufacture of a new chemical substance in the U.S. applies to the import of new chemicals, as does the section 5(a)(2) significant new use notice (SNUN) requirement. Thus, the intended import of chemical substances can trigger the following provisions:

• Premanufacture notice provisions for new chemicals in 40 CFR 720;
• Significant new use notice provisions in 40 CFR 721;
• Premanufacture notice exemptions for new chemicals in 40 CFR 723; and
• Reporting requirements for inter-generic microorganisms in 40 CFR 725.

Import requirements in TSCA section 5(e) orders and section 5(a)(2) significant new use rules

When appropriate, EPA issues section 5 regulatory requirements on new chemicals or significant new uses of chemicals via a TSCA section 5(e) order or section 5(a)(2) significant new use rule (SNUR, 40 CFR Part 721 or 725 Subparts L and M).

TSCA section 5(e) orders may include use prohibitions, labeling and safety data sheet (SDS) requirements, restrictions on the amount of the chemical allowed to be manufactured (including imported), as well as other restrictions. (The import/production limits often serve as triggers for toxicity or related testing requirements.) SNURs require notifying EPA at least 90 days before manufacture (including import), or processing for uses/activities designated by EPA as a significant new use.

To comply with these requirements when applicable, chemical substances must:

• Not be imported for any prohibited use,
• Satisfy all applicable labeling and SDS requirements,
• Not exceed any specified restrictions on permissible import volume,
• Not be imported for any designated significant new use, and
• Comply with any other applicable requirements.

Testing

• EPA has the authority to require manufacturers (including importers) and processors of chemical substances and mixtures to conduct testing on the health and environmental effects of chemical substances and mixtures.

Under section 4 of the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has the authority to require manufacturers (including importers) and processors of chemical substances and mixtures to conduct testing on the health and environmental effects of chemical substances and mixtures.

A person who imports or intends to import a chemical substance or mixture subject to a test rule under section 4 must comply with section 4 requirements unless the importation qualifies for an exemption included in the regulations at 40 CFR 790.42, or under a specific test rule listed under 40 CFR 766 or 799.

Following promulgation of a test rule under section 4, the responsibility to comply with the rule continues for a period of five years from the date the data from all required tests have been submitted or an amount of time equal to that which was required to develop the test data, whichever is longer. Importers therefore have a continuing responsibility to determine whether a chemical substance or mixture which they import or intend to import is subject to a test rule.

Reporting and recordkeeping

• Specific TSCA section 8 rules apply to importers.

Section 8 of the Toxic Substances Control Act (TSCA) authorizes the Environmental Protection Agency (EPA) to require persons that manufacture (includes import), process, and distribute in commerce TSCA-covered chemical substances and mixtures to keep certain records and report certain information to EPA. Specific TSCA section 8 rules (and implementing policy documents in the case of section 8(e)) that apply to importers include:

• TSCA Section 8(a) Chemical Data Reporting (CDR) – See 40 CFR 711.
• TSCA Section 8(a) Preliminary Assessment Information Reporting (PAIR) Rule – See 40 CFR 712.
• TSCA Section 8(a) Chemical Specific Recordkeeping and Reporting Rules – See 40 CFR 704 Subpart B.
• TSCA Section 8(c) Allegations of Significant Adverse Reactions Recordkeeping and Reporting Rule – See 40 CFR 717.
• TSCA Section 8(d) Unpublished Health and Safety Data Reporting Rule – See 40 CFR 716.
• TSCA Section 8(e) Substantial Risk Information Reporting Requirement (Statutory Provision) – See implementing Policy Statement (43 FR 11110, March 16, 1978), as well as the TSCA Section 8(e) Reporting Guide dated June 1991 (available in hard copy from TSCA Hotline).

Exporting specific chemicals

• TSCA prohibits export of PCBs.
• Export of metallic mercury is also prohibited.

Section 6 of the Toxic Substances Control Act (TSCA) contains export requirements applicable to some specific chemicals:

• PCBs — Section 6(e) of TSCA prohibits export of polychlorinated biphenyls (PCBs). See 40 CFR 761 for regulations on the export of PCBs. In certain limited circumstances, the Environmental Protection Agency (EPA) may grant exemptions to allow export of PCBs, provided statutory and regulatory requirements are met.
• Elemental (metallic) mercury — The Mercury Export Ban Act was signed into law on October 14, 2008. The law intends to reduce the availability of elemental (metallic) mercury in domestic and international markets. By reducing the supply of metallic mercury in commerce, the Act aims to reduce the use of mercury for commercial purposes globally. The Act's three main provisions are the following:
  • Federal agencies are prohibited from conveying, selling, or distributing metallic mercury that is under their control or jurisdiction. This includes stockpiles held by the Departments of Energy (DOE) and Defense (DOD).
  • Export of metallic mercury is prohibited from the U.S. beginning January 1, 2013.
  • DOE shall designate one or more DOE facilities for long-term management and storage of metallic mercury generated within the U.S. This designation began on January 1, 2010.

• Any person residing in the U.S. may petition EPA for an exemption from the prohibition on export of metallic mercury.

In addition to the chemicals listed above, export requirements or prohibitions apply to the following types of chemicals covered by TSCA section 6 regulations:

• Certain chemical substances that may be used in metalworking fluids and that are regulated under 40 CFR 747.
• Certain hexavalent-chromium-based water treatment chemicals that are regulated under 40 CFR 749.68.
• Certain asbestos-containing products that are regulated under 40 CFR 763.

Manufacturing new chemicals solely for export

• A new chemical substance is exempt from the PMN requirement if it is manufactured solely for export and certain conditions are met.

Under section 12(a) of the Toxic Substances Control Act (TSCA) and 40 CFR 720.30(e), a new chemical substance is exempt from the premanufacture notice (PMN) requirement if it is manufactured solely for export and if, when the substance is distributed in commerce:

• The substance is labeled "for export" in accordance with section 12(a)(1)(B) of the Act; and
• The manufacturer knows that the person to whom the substance is being distributed intends to export it or process it solely for export as defined in 40 CFR 721.3.

It should be noted that chemical substances, mixtures, or articles can be covered by TSCA if EPA finds that the substance will present an unreasonable risk within the U.S. For example, EPA may require that the substance be tested.

Requesting access to CBI

• TSCA allows EPA, under certain conditions, to disclose CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders.

Amendments to the Toxic Substances Control Act (TSCA) expanded the categories of people who may now access information claimed as confidential business information (CBI) under TSCA. Information that a business claims as CBI under TSCA is protected from disclosure until the business withdraws the CBI claim, the CBI claim expires, the Environmental Protection Agency (EPA) determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.

TSCA allows EPA, under certain conditions, to disclose CBI to:

• State, tribal, and local governments;
• Environmental, health, and medical professionals; and
• Emergency responders.

A person may be able to request access to the following types of information that are often claimed as CBI under TSCA:

• Specific chemical identity (e.g., the specific name of the chemical),
• Company name,
• Production figures,
• Manufacturing or processing details,
• Specific uses, and
• Names of individual company or laboratory personnel.

Be sure to review EPA's guidance documents for accessing CBI under TSCA before submitting a request:

• Guidance for Requesting Access to CBI for State, Tribal, and Local Governments.
• Guidance for Requesting Access to CBI for Environmental, Health, and Medical Professionals.
• Guidance for Requesting Access to CBI for Emergency Responders.

Making CBI claims in TSCA submissions

• There are several procedural requirements that must be followed when asserting CBI claims in TSCA submissions.
• If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided.

Under section 14(a) of the Toxic Substances Control Act (TSCA), submitters may claim information submitted to the Environmental Protection Agency (EPA) under TSCA as confidential business information (CBI). CBI claims must be asserted and substantiated concurrently with the submission of the information, except for those types of information exempt under TSCA section 14(c)(2).

Examples of information that may not be protected as CBI

TSCA section 14(b) identifies certain information that may not be protected as CBI, including:

• Health and safety studies and information from health and safety studies where the chemical or mixture has been offered for commercial distribution or for which testing is required under TSCA section 4 or notification is required under TSCA section 5. However, process information and portions of mixture information may be protected;
• Any general information describing manufacturing volumes, expressed as specific aggregated volumes or, if the EPA Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges; and
• A general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector.

How to make CBI claims in TSCA submissions

There are several procedural requirements that must be followed when asserting CBI claims in TSCA submissions. The procedural requirements for making a CBI claim include:

• The required certification statements;
• Information claimed as CBI is clearly identified;
• Substantiation of CBI claims for information that is not exempt from substantiation under section 14(c)(2);
• Sanitized copy provided where needed; and
• A structurally descriptive generic name, if a CBI claim is for a specific chemical identity.

The authorized official submitting CBI claims must make several assertions as well as certify that information submitted to substantiate a CBI claim is true and correct, as required by sections 14(c)(1)(B) and 14(c)(5) of TSCA.

EPA has combined these requirements into the certification statement (below) that can be used to satisfy these requirements. If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided.

Certification Statement for CBI Claims

I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate. I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that

1. My company has taken reasonable measures to protect the confidentiality of the information;
2. I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
3. I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
4. I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001.

Electronic and paper submissions of CBI

• In most cases, information that may be claimed as CBI includes a checkbox for designating the information as CBI adjacent to the field where the information is to be entered.
• If information in an electronic submission is claimed as CBI, the official making the submission will be prompted to upload a document substantiating the CBI claims or providing a reason why the submitter believes no substantiation is required.

Electronic submissions of CBI

Most Toxic Substances Control Act (TSCA) submissions are required by regulation to be submitted electronically. The Environmental Protection Agency (EPA) electronic reporting systems within the Central Data Exchange (CDX) prompt users for some required elements when confidential business information (CBI) claims are made.

TSCA electronic reporting tools are available in the Chemical Safety and Pesticide Programs (CSPP) portion of EPA’s CDX. The electronic reporting applications for many TSCA submission types are based on fillable forms where each data element is entered individually. In most cases, information that may be claimed as CBI includes a checkbox for designating the information as CBI adjacent to the field where the information is to be entered.

In cases in which the electronic reporting application does not support making a CBI claim adjacent to where the information is entered (for example, if a submission includes document attachments), the submitter is responsible for indicating what information is being claimed as CBI. For documents created outside of the CDX reporting application that include CBI claims, both the complete document (with information claimed as CBI shown) and a sanitized version (with CBI redacted or otherwise masked) generally must be attached to the submission.

For electronic submissions, the certification statement is incorporated into the reporting application. The official making the submission will be prompted to agree to the certification statement prior to being able to complete the submission.

If a specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided. Electronic reporting applications are being modified to provide a field for inputting a structurally descriptive generic name for all submission types.

If information in an electronic submission is claimed as CBI, the official making the submission will be prompted to upload a document substantiating the CBI claims or providing a reason why the submitter believes no substantiation is required under section 14(c)(2).

Paper submissions of CBI

While most TSCA submissions are required by regulation to be submitted electronically, several submission types may still be submitted on paper. Submitters should follow the instructions for submitting found in the applicable regulations and EPA-issued guidance. A paper submission with CBI claims must include the certification statement. If specific chemical identity is claimed as CBI, a structurally descriptive generic name must also be provided.

Substantiating CBI claims at time of initial submission

• In order for EPA to make a determination regarding the validity of a CBI claim in a particular TSCA submission, information regarding the basis for the CBI claim must be provided.
• EPA has developed substantiation templates that may be used as a starting point in preparing CBI substantiations for uploading into CDX electronic reporting applications or for inclusion with submissions made via paper.
• Certain information is generally not subject to substantiation requirements including marketing and sales information.

Those submissions containing information claimed as confidential business information (CBI) filed on or after March 21, 2017, must provide a substantiation for all information claimed as confidential, other than information exempt from substantiation pursuant to Toxic Substances Control Act (TSCA) section 14(c)(2), at the time of submission.

How to submit substantiations of CBI claims

The Environmental Protection Agency’s (EPA’s) electronic reporting systems for TSCA submissions have been modified to accept substantiations for CBI claims in submissions filed on or after March 21, 2017. In addition, any new paper TSCA submissions that are directed to the agency after that date must include substantiations for all non-exempt CBI claims at the time of submission.

What to include in CBI substantiations

In order for EPA to make a determination regarding the validity of a CBI claim in a particular TSCA submission, information regarding the basis for the CBI claim (i.e., substantiation) must be provided. Submitters may provide to EPA any information they believe supports the validity of their CBI claims.

When reviewing and making a CBI determination, EPA considers each CBI claim and corresponding substantiation, the provisions of TSCA and applicable regulations, any previously issued determinations which are pertinent, and other relevant materials as appropriate.

Note that while each information element claimed as CBI and not exempt from substantiation must be substantiated, in some cases, it may be appropriate to group the information into a class of information rather than responding to each item claimed as CBI. For example, information that identifies a company, including the company name, address, official, and technical contact names and telephone numbers, and other identifying data could be grouped together and a single set of substantiation responses provided in support of CBI claims for all those information elements.

EPA has found that an effective means for providing information to support the validity of a CBI claim is in the form of responses to the following substantiation questions found in 40 CFR 2.204(e)(4).

• The portions of the information which are alleged to be entitled to confidential treatment;
• The period of time for which confidential treatment is desired by the business (e.g., until a certain date, until the occurrence of a specified event, or permanently);
• The purpose for which the information was furnished to EPA and the approximate date of submission, if known;
• Whether a business confidentiality claim accompanied the information when it was received by EPA;
• Measures taken by the business to guard against undesired disclosure of the information to others;
• The extent to which the information has been disclosed to others, and the precautions taken in connection therewith;
• Pertinent confidentiality determinations, if any, by EPA or other federal agencies, and a copy of any such determination, or reference to it, if available;
• Whether the business asserts that disclosure of the information would be likely to result in substantial harmful effects on the business' competitive position, and if so, what those harmful effects would be, why they should be viewed as substantial, and an explanation of the causal relationship between disclosure and such harmful effects; and
• Whether the business asserts that the information is voluntarily submitted information as defined in 40 CFR 2.201(i), and if so, whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.

In order to assist submitters in substantiating their CBI claims, EPA has developed substantiation templates that may be used as a starting point in preparing their CBI substantiations for uploading into Central Data Exchange (CDX) electronic reporting applications or for inclusion with submissions made via paper. Submitters are encouraged to use these substantiation template documents but are not required to do so.

Information exempt from substantiation

TSCA section 14(c)(2) identifies certain information that is generally not subject to substantiation requirements. This information includes:

• Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article;
• Marketing and sales information;
• Information identifying a supplier or customer;
• In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents;
• Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article;
• Specific production or import volumes of the manufacturer or processor; and
• Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA section 5.

EPA review and determination of CBI claims

• EPA evaluates submissions with CBI claims to ensure that the procedural requirements for making a claim are met.
• EPA makes a determination on the validity of each CBI claim in the context of the submission in which it is received.

Toxic Substances Control Act (TSCA) section 14(g)(1) requires that the Environmental Protection Agency (EPA), within 90 days of receipt of the claim:

• Review and make determinations on confidential business information (CBI) claims for chemical identity after the chemical substance has been offered for commercial distribution; and
• Review and make determinations on a representative subset of at least 25 percent of other CBI claims that are not exempt from substantiation and review.

EPA evaluates submissions with CBI claims to ensure that the procedural requirements for making a claim are met. These requirements include:

• The required certification statements;
• Information claimed as CBI is clearly identified;
• Substantiation of CBI claims for information that is not exempt from substantiation under section 14(c)(2);
• Sanitized copy provided where needed; and
• A structurally descriptive generic name, if a CBI claim is for specific chemical identity.

EPA considerations for CBI determinations

Once EPA verifies that all the procedural requirements for making a CBI claim have been satisfied, EPA considers each of the following in making a CBI determination:

• A business’s claim and substantiation;
• The provisions of TSCA and applicable regulations;
• Any previously issued determinations which are pertinent; and
• Other materials as appropriate.

EPA's determinations identify the specific information in the case for which the CBI determination applies. In some instances, a determination only covers the specific chemical identity of the chemical substance. In other instances, a CBI determination covers all of the other non-exempt information in a case. Finally, in some instances, a CBI determination is made for both the specific chemical identity of the chemical substance and for all of the other non-exempt information in the case.

While EPA will consider prior confidentiality determinations as one factor in making a determination under TSCA, EPA makes a determination on the validity of each CBI claim in the context of the submission in which it is received. A determination of the validity of a CBI claim is made using the information EPA has been provided regarding the claims in the submission under review. For this reason, EPA advises submitters to substantiate CBI claims by looking carefully at the contents of each submission and providing all the information the submitter feels EPA should consider when making a determination.

CBI claims can be approved, approved in part, denied in part, or denied by EPA as a result of a review. If a claim is approved in part and denied in part or denied, EPA provides a written statement explaining the reasons for the denial or denial in part according to the provisions of TSCA section 14(g)(2). Submitters whose claims have been asserted according to the requirements in section 14(c) and which have been approved in part and denied in part or denied can appeal the denial in a U.S. District Court according to the requirements of TSCA section 14(g)(2)(D).

Deficient TSCA CBI claims

• One of the most common deficiencies that EPA sees is that submitters substantiate only some of the information claimed as CBI.
• Generic name deficiencies in CBI submissions include having a missing generic name and not having a structurally descriptive name.

Submitters should carefully review the entirety of their confidential business information (CBI) claim submission to avoid deficiencies.

Note that EPA no longer sends out notices of deficiency to businesses who fail to substantiate non-exempt CBI claims or otherwise submit CBI claims without complying with TSCA statutory requirements at the time the information is submitted to EPA. Instead, the agency provides written notice to affected business submitters who submit procedurally flawed CBI claims, including unsubstantiated CBI claims, that those CBI claims are invalid and not entitled to protection under TSCA section 14.

Certification deficiencies

Certification deficiencies in CBI submissions include:

• Missing certification statement — All CBI claims must be accompanied by a CBI certification statement.
• No signature — Certification provided, but not signed.
• Wrong certification — Certification provided, but wrong one or it does not meet the requirements of the law.

Certification deficiencies generally only occur in Toxic Substances Control Act (TSCA) submissions made on paper because the TSCA Central Data Exchange (CDX) electronic reporting applications were modified to require the appropriate certification statement.

Substantiation deficiencies

One of the most common deficiencies that the Environmental Protection Agency (EPA) sees is that submitters substantiate only some of the information claimed as CBI. In particular, submitters will often only substantiate claims for specific chemical identity but not for other information that is claimed as CBI. Substantiation deficiencies in CBI submissions include:

• Missing substantiation — Substantiation is required for all information elements claimed as CBI except for information that EPA recognizes as exempt from substantiation under TSCA section 14(c)(2).
• Partially substantiated — Substantiation is required for all information elements claimed as CBI except for information that is exempt from substantiation under TSCA section 14(c)(2). Note that certain types of TSCA submissions, including Chemical Data Reporting (CDR) and premanufacture notices (PMNs) provide for substantiations of specific CBI claims within the electronic reporting forms. The substantiations provided for the specific CBI claims in these submissions are only applicable to the specific information noted and are not applicable to other information claimed as CBI in those submissions. Other information that is claimed as CBI in these submissions must also be substantiated. EPA encourages submitters to use the agency’s sample substantiation templates for substantiating these other CBI claims.
• Claims information is exempt from substantiation — The agency has identified specific information elements as exempt from substantiation. The exempt elements do not have to be substantiated. However, if a person has claimed information that the agency has not recognized as exempt from substantiation, this is the opportunity to substantiate those claims. Optionally include in the substantiation response a detailed explanation of why this information should be exempt from substantiation and why, if the agency does not agree with this position, the information would qualify as CBI under TSCA. The submitter should cite applicable law and facts specific to the submission to support the assertion.

EPA encourages submitters to utilize the sample substantiation templates that have been developed to assist them with fully substantiating all CBI claims. If a submitter wishes to assert that certain information is exempt from substantiation, it should be noted in the substantiation response, citing the exemption and the reason it applies.

Generic name deficiencies

Generic name deficiencies in CBI submissions include:

• Missing generic name — The new law requires that any time a submitter claims chemical name as CBI, the submitter must provide a structurally descriptive generic name.
• Not structurally descriptive name — The provided generic name does not meet generic name criteria.

Submitters should follow EPA’s guidance for developing generic names.

EPA disclosure of data

• Information from “health and safety studies” is not protected, unless disclosure would reveal specific manufacturing and processing information or a mixture’s chemical proportions.

Toxic Substances Control Act (TSCA) section 14(b) provides that certain categories of information are not protected from disclosure. In particular, information from “health and safety studies” is not protected, unless disclosure would reveal specific manufacturing and processing information or a mixture’s chemical proportions. It is presumed that information can be released when it pertains to chemicals that the Environmental Protection Agency (EPA) has banned or phased out.

For specific chemical identities determined to warrant confidential treatment, TSCA section 14 requires the use of unique generic identifiers when disclosing the chemical names may provide information about the structure and identity of a chemical substance.

Even when information warrants confidential treatment, section 14 establishes circumstances in which such information may or must be disclosed. For instance, such information must be disclosed for certain law enforcement purposes, or to states, localities, tribes, and health or environmental professionals if EPA determines that disclosure is necessary to protect health or the environment against an unreasonable risk.

Preemption of state requirements and exemptions to preemption

• TSCA section 18 contains two preemption sections that prohibit different kinds of state or local regulations corresponding to different stages in EPA’s review process under TSCA.
• Section 18 also provides exceptions that, in effect, preserve state chemical requirements that otherwise would be preempted.

Preemption of state requirements

Under the Supremacy Clause of the U.S. Constitution, state law and policy must yield to the exercise of Congress’s powers if Congress so intends. As Congress debated whether to expand EPA authority to regulate chemicals under TSCA leading up to the enactment of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), federal preemption of state requirements was a key issue.

As enacted in 1976, TSCA preempted state and local requirements only for specific chemicals. Some states and localities enacted their own laws or promulgated regulations pertaining to other chemicals in response to concerns regarding the risks of commercial chemicals and the absence of federal regulatory action. The chemical industry and associated entities (e.g., retailers) expressed concern over regulatory requirements that differed from one state to another.

In response, the LCSA revised TSCA’s preemption provisions. In broad terms, TSCA section 18 prohibits specific state and local actions, and then restricts the reach of those prohibitions through limitations, exceptions, and waivers. Any preemption is chemical-specific, and EPA must take specific actions under TSCA in order to trigger the preemption of state regulation of chemicals. Exceptions to preemption may apply under certain conditions, and EPA may grant preemption waivers by rule.

As amended, section 18 contains two preemption sections that prohibit different kinds of state or local regulations corresponding to different stages in EPA’s review process under TSCA:

• TSCA section 18(a) prohibitions — The prohibitions in section 18(a) apply once EPA implements information requirements, notification of significant new use requirements, or restrictions or prohibitions based on its risk evaluation for the particular chemical. Under section 18(a), once EPA has acted to regulate a chemical, no state may establish or continue to enforce any of the following, subject to exemptions and potential waivers:
  • A statute or administrative action that requires the development of information on a chemical that would be “reasonably likely” to be the same as information required under an existing EPA rule, order, or consent agreement under the Act.
  • A statute, criminal penalty, or administrative action to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical for which EPA has either: (1) issued an order finding the chemical not to present an unreasonable risk, or (2) found the chemical to present an unreasonable risk and promulgated a final rule to address the unreasonable risk after the effective date of the rule.
  • A statute or administrative action requiring the notification of a use of a chemical for which EPA has already determined that notification as a significant new use is required.
• TSCA section 18(b) prohibitions — The prohibitions in section 18(b) apply while EPA is conducting its risk evaluation of a particular chemical, beginning on the date EPA determines the scope of its risk evaluation and ending either on the deadline for completion of the risk evaluation or when EPA publishes the risk evaluation, whichever is earlier. Section 18(b) imposes a temporary prohibition on states from establishing any new prohibition or restriction on a chemical designated by EPA as a high-priority substance for risk evaluation. States are preempted from regulating only the hazards, exposures, risks, and uses included in the scope of EPA’s risk evaluation.

Exceptions to preemption

Section 18 provides exceptions that, in effect, preserve state chemical requirements that otherwise would be preempted. States and localities may continue to enforce any chemical substance prohibitions or restrictions that were in effect before April 22, 2016. States and localities also may adopt new regulations and other actions pursuant to any laws in effect on August 31, 2003.

TSCA also leaves in place the “cooperative federalism” structure of several other federal environmental laws, under which states administer programs that either meet or exceed minimum federal requirements. Thus, it does not preempt a state from adopting or enforcing any rule, standard of performance, risk evaluation, scientific assessment, or any other protection for public health or the environment that:

• Is adopted under the authority of or to satisfy any other federal law;
• Implements a reporting, monitoring, disclosure, or other information obligation not otherwise required by the EPA under TSCA or required under other federal law; or
• Is generally adopted under a state law related to water quality, air quality, or waste treatment or disposal, with certain exceptions.

In addition to these exemptions from preemption, TSCA sets forth “savings clauses,” providing that the Act’s requirements do not preempt penalties for criminal conduct or common law rights or statutes creating remedies for civil relief — such as damages — under any legal theory of liability. TSCA also provides that determinations, such as risk assessments, made pursuant to the statute are not definitive proof in court for private actions.

In addition to the specific statutory exemptions, section 18 allows EPA the discretion to exempt from preemption a state requirement under certain circumstances. If the state submits an application for the exemption, EPA may grant the exemption if the agency determines that compelling conditions warrant granting the waiver to protect health or the environment, that compliance with the requirement would not unduly burden interstate commerce and would not cause a violation of federal requirements, and that the risk identified by the state is based on sufficiently strong science.

EPA must exempt from preemption new state requirements established during EPA’s risk evaluation period for a chemical if either the:

1. State requirement is enacted within 18 months of EPA’s prioritization of the chemical for review; or
2. EPA determines that compliance with the requirement would not unduly burden interstate commerce or cause a violation of federal requirements, and that the state’s concern about the chemical is based on peer-reviewed science.

EPA must act on a required exemption application within 110 days after an application is submitted. All waiver applications are subject to public notice and comment requirements, and decisions regarding such applications are final agency actions subject to judicial review.

Co-enforcement and state grants

• Penalties and other sanctions that are applicable to violations under state law must not be more stringent than those available under TSCA.

Co-enforcement

Section 18 of the Toxic Substances Control Act (TSCA) also establishes parameters for states that adopt and enforce requirements under their own laws that are identical to TSCA requirements. Penalties and other sanctions that are applicable to violations under state law must not be more stringent than those available under TSCA.

Additionally, a state may not assess a penalty for a violation under its own law if the Environmental Protection Agency (EPA) has already assessed an adequate penalty for the same violation under TSCA. If a state has already assessed a penalty for a specific violation under state law, TSCA limits the penalty EPA may assess for the same violation so that the combined total penalty amount would not exceed the maximum penalty amount allowed under the Act. Under this scheme, regulated entities may face enforcement by either state or federal regulators.

State grants

TSCA Section 28 authorizes EPA to award grants to states to establish and operate programs intended to prevent or eliminate unreasonable risks associated with chemicals for which the agency “is unable or is not likely to take action” under the Act. Section 28 limits grant awards to 75 percent of the establishment and operation costs of the program.

The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) repealed the authorization of appropriations for state grants but not the program authority, and Congress has continued to provide TSCA grant funding to states through annual discretionary appropriations.