Certification and Registration
TSCA: US. Toxic Substances Control Act
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TSCA: U.S. Toxic Substances Control Act
TSCA Announcement on PBT Substances
In January 2021, the US. Environmental Protection Agency (EPA) issued a final rule in the Federal Register under the Toxic Substances Control Act (TSCA) to restrict the use of five persistent, bioaccumulative, and toxic (PBT) chemical substances. The basic information of these five PBT substances is as follows:
|
Substance Name |
CAS No. |
Limit |
Common Uses |
|
2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP) |
732-26-3 |
0.3% |
Antioxidant used in fuel additives and cleaner formulations, as well as an additive in lubricating oils and greases. |
|
Decabromodiphenyl Ether (DecaBDE) |
1163-19-5 |
Prohibited |
Flame retardant used in wire and cable insulation, textiles, electronic equipment housings, building and construction materials, aerospace applications, and automotive parts. |
|
Phenol, Isopropylated Phosphate (3:1) (PIP 3:1) |
68937-41-7 |
Prohibited |
Flame retardant used in plastics and as a functional fluid in aircraft and industrial machinery. |
|
Pentachlorothiophenol (PCTP) |
133-49-3 |
1% |
Used in the rubber industry. |
|
Hexachlorobutadiene (HCBD) |
87-68-3 |
Prohibited |
Used as a solvent in rubber manufacturing and in hydraulic fluids and transformer fluids. |
The restriction requirements under the final rule for these five substances will be implemented in phases starting from March 8, 2021. Relevant companies should pay attention to product compliance requirements in advance; otherwise, their products may be prohibited from being placed on the market.
Introduction to TSCA
The US. Toxic Substances Control Act (TSCA) was enacted by the US. Congress in 1976 and came into effect in 1977. The US. Environmental Protection Agency (EPA) is responsible for implementing and enforcing specific policies, while the US. Customs and Border Protection (CBP) works with the EPA to conduct routine inspections of imported chemical substances. On June 7, 2016, the US. Senate unanimously passed the Lautenberg Act (H.R. 2576). This regulation represented the first major reform of the Toxic Substances Control Act (TSCA), which had been in effect for more than 40 years, and has had profound historical significance for chemical management in the United States.
The TSCA aims to comprehensively consider the impacts of chemical substances circulating in the United States on the environment, economy, and society, and to prevent “unreasonable risks” to human health and the environment. After multiple revisions, TSCA has become an important regulation for the effective management of chemical substances in the United States.
TSCA Inventory
The TSCA Inventory is a dynamic inventory containing more than 85,000 chemical substances, which are divided into public and confidential portions. TSCA classifies regulated chemical substances into two categories: “existing chemical substances” and “new chemical substances.” Substances already listed in the TSCA Inventory are considered existing chemical substances, while those not listed are considered new chemical substances. Certain chemical substances with specific uses are not regulated under TSCA. The details are shown in Table 1.
Table 1: Chemical Substances Not Regulated Under the TSCA Regulations
|
No. |
Substance Category |
No. |
Substance Category |
|
1 |
Tobacco Products |
5 |
Food Additives |
|
2 |
Nuclear Materials |
6 |
Pharmaceuticals |
|
3 |
Firearms |
7 |
Cosmetics |
|
4 |
Food |
8 |
Insecticides and Pesticides |
As shown in Table 1, TSCA mainly regulates industrial chemical substances, while eight categories of chemical substances, including tobacco products and nuclear materials, are managed under specific regulations due to their special uses. For example, food, food additives, pharmaceuticals, and cosmetics are regulated by the US. Federal Food, Drug, and Cosmetic Act (FDA).
Management of Existing Chemical Substances
Under TSCA regulations, manufacturers and importers of existing chemical substances are required to fulfill four different compliance obligations. The details are shown in Table 2.
Table 2: Different Compliance Services
|
Compliance Service |
Specific Requirements |
Scope of Application |
|
TSCA Positive Certification |
Importers are required to declare whether the imported chemical substances comply with TSCA regulatory requirements and provide a positive certification statement. |
All chemical substances regulated under TSCA, except tobacco and tobacco products; mixtures or products containing intentionally released chemicals. |
|
TSCA Negative Certification |
Importers are required to declare whether the imported chemical substances are subject to TSCA regulatory requirements and provide a negative certification statement. |
Pesticides (excluding pesticide intermediates), nuclear materials, food, food additives, pharmaceuticals, and cosmetics. |
|
Significant New Use Notification (SNUN) |
Before manufacturing, importing, processing, or using a substance, companies must submit a SNUN notification to the EPA at least 90 days in advance. |
Chemical substances listed in the TSCA inventory that have an “S” (Significant New Use) designation. |
|
Chemical Data Reporting (CDR) |
Manufacturers and importers must report production/import quantities, usage activities, exposure information, and other relevant data to the EPA every four years. |
Chemical substances listed in the TSCA inventory. Since 2011, applicable to annual production or import quantities exceeding 25,000 pounds (approximately 11.3 metric tons) at any single site. |
Management of New Chemical Substances
For new chemical substances that are not listed in the TSCA Inventory, information regarding their production, use, hazards, and exposure is considered unknown. According to TSCA requirements, a Pre-Manufacture Notice (PMN) must be submitted to the EPA before importing or manufacturing such substances. Manufacturers/importers must submit PMN documentation to the EPA at least 90 days in advance to allow the EPA to conduct a review. For certain chemical substances with special uses or small production volumes, such as substances manufactured in small quantities and used only for research and development, or substances used only for commercial development and market testing, the EPA has established specific exemption conditions under which companies may submit an exemption application for PMN requirements.
TSCA Compliance Recommendations
1. Determine whether the product falls within the scope of TSCA regulation and identify whether the substances contained in the product are new chemical substances;
2. For new chemical substances that do not meet exemption requirements, a Pre-Manufacture Notice (PMN) must be submitted; for existing chemical substances, determine whether a Significant New Use Notification (SNUN) is required;
3. For general chemical substances, a TSCA compliance statement or exemption statement shall be completed;
4. If the substance is an existing chemical substance and the annual export volume exceeds 25,000 pounds (approximately 11.3 tons), a Chemical Data Reporting (CDR) submission is required.
SATISFY recommends that chemical companies pay close attention to TSCA requirements before exporting chemical substances to the United States and ensure compliance with relevant TSCA obligations. SATISFY can provide TSCA compliance recommendations and technical support for enterprise customers.
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