What Is the Toxic Substances Control Act (TSCA)?
June 7, 2023
The Toxic Substances Control Act (TSCA) gives the EPA authority to place restrictions on specialty chemical substances or mixtures and requires reporting, recordkeeping, and hazmat testing relative to their production, importation, use, and hazardous waste disposal. It additionally authorizes the EPA to control any toxic substances that are determined to cause unreasonable risk to public health or the environment. This entry provides information about the TSCA. Q&As include:
1. What are the main objectives of the TSCA?
2. What is the TSCA inventory list?
3. What materials are regulated under the TSCA?
4. How often must TSCA information be reported?
5. How do you submit a TSCA report to the EPA?
6. Are there consequences for TSCA noncompliance?
7. Is there a TSCA telephone number?
8. What is a TSCA certification statement?
9. What does FIFRA stand for?
10. What is a desiccant?
11. What is a nitrogen stabilizer?
12. Who must report to the EPA under TSCA rules?
13. What defines a toxic substance?
14. Where can you get expert advice about TSCA filings?
1. What are the main objectives of the TSCA?
The TSCA was passed in 1976 with three main objectives:
- Assess and regulate new commercial chemicals before they enter the market.
- Regulate the chemicals that already existed in 1976 that were posing an unreasonable risk to health or the environment (e.g., PCBs, lead, mercury, and radon).
- Regulate the distribution and use of chemicals listed in (1) and (2) above (see source).
2. What is the TSCA inventory list?
This is a comprehensive list maintained by the EPA containing chemical substances manufactured or processed in the United States—both confidential and non-confidential (see source).
3. What materials are regulated under the TSCA?
Toxic substances regulated by the TSCA include PCBs, asbestos, formaldehyde, lead, mercury, and various hexavalent chromium compounds. However, food, drugs, cosmetics, pesticides, tobacco, radioactive materials, and certain other substances are generally excluded from TSCA regulations. Instead:
- The FDA regulates food, drugs, and cosmetics.
- Pesticides fall under the auspices of the FIFRA (see Q.9).
- Tobacco and tobacco products live under the wary eye of the ATF.
- Radioactive materials are overseen by the NRC (see source).
4. How often must TSCA information be reported?
Information is required from manufacturers and importers quadrennially, generally when production volumes for a chemical are 25,000 lbs. or more for a specific reporting year.
5. How do you submit a TSCA report to the EPA?
We wish we had better news. But you have to deal with a government website. In this case, it’s something called e-PMN software, which ostensibly enables manufacturers and importers of TSCA chemical substances to submit reports online. These notices include but are not limited to:
- Premanufacture notices (PMNs)
- Bona fide notices
- Biotechnology Notices for genetically modified microorganisms
- Notices of Commencement of Manufacture (NOCs)
6. Are there consequences for TSCA noncompliance?
Do “criminal fines of up to $50,000 for each day the violation continues and or imprisonment for up to one year, or both” sound like consequences to you? (See source)
7. Is there a TSCA telephone number?
Yes. And your call is undoubtedly important to them.
A Toxic Substances Control Act Hotline is available at 800-471-7127 to answer general questions and document requests about TSCA requirements. It operates Monday through Friday, 8:00 AM to 6:00 PM Eastern time.
8. What is a TSCA certification statement?
There are two kinds: positive and negative.
- A TSCA positive certification statement declares that all chemicals contained in a shipment comply with all applicable TSCA rules or orders. E.g., “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.”
- A TSCA negative certification statement declares that none of the chemicals contained in a shipment are subject to any TSCA rules or orders. E.g., “I certify that all chemical substances in this shipment are not subject to TSCA.” (See source)
You want to make sure you’re speaking the truth, the whole truth, and nothing but the truth when you sign one of these statements. Why? See Q.6.
9. What does FIFRA stand for?
We knew you were going to ask that.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United States governs the registration, distribution, sale, and use of pesticides.
Per the FIFRA, and with a few caveats to the contrary, a pesticide is any toxic substance or mixture meant for preventing, destroying, repelling, or mitigating any pest. Ditto if it’s a plant regulator, defoliant, desiccant (see Q.10), or nitrogen stabilizer (See Q.11).
10. What is a desiccant?
We can do no better than to quote this source. To wit:
“Desiccants are a packaging component used in assisting humid environments by absorbing moisture content from the air. Normally used in shipping, storage, or preservation of materials and products, desiccants are used to keep everything from shoes to military ammunition dry!”
(N.B. We note that desiccants are often stamped DO NOT EAT. Apparently, people are walking among us who are, for example, inclined to eat the packing materials they find at the bottom of shoe boxes. Whomever these people are, keep them safely separated from your hazardous waste streams. Just sayin’.)
11. What is a nitrogen stabilizer?
Farmers need a way to keep nitrogen in their soils instead of its disappearing into thin air. Nitrogen stabilizers are formulated to prevent or hinder nitrification, denitrification, and or ammonia volatilization. They must be registered under FIFRA (see source).
12. Who must report to EPA under TSCA rules?
If you’re a manufacturer, importer, processor, or distributor of specialty chemicals, TSCA requires that you submit lists and copies of unpublished health and safety studies of those chemicals to the EPA, particularly if you have information that indicates such chemicals present a substantial risk of injury to human health or the environment.
This includes small production or importation volumes, as well as small-scale commercial activities (e.g., manufacture only for export or R&D). The TSCA does not exempt small businesses from these reporting requirements (see source).
13. What defines a toxic substance?
A substance exhibits toxicity when it’s harmful or fatal if ingested or absorbed or can leach into the soil or groundwater when disposed of on land. But be mindful that the terms “hazardous substance,” “toxic substance,” and “corrosive substances” are often used interchangeably. Technically, this is wrong. And the EPA often muddles its terminology when communicating with its public. Consider:
Many nontoxic substances are nonetheless RCRA hazardous. This is because toxic substances are actually a category of hazardous substances. So while a toxic substance is hazardous, the reverse isn’t necessarily true. I.e., a hazardous substance might be nontoxic, but nonetheless RCRA hazardous for some other reason. How so?
A substance might be RCRA hazardous because the EPA lists it as being dangerous and or ecologically harmful for many different reasons. Therefore, it’s a “listed” hazardous material. Or if it isn’t “listed,” it might nonetheless be considered RCRA hazardous for one or more of four characteristics (i.e., ignitability, corrosiveness, reactivity—and under discussion here—toxicity). Therefore, it’s a “characteristic” hazardous material (see source).
14. Where can you get expert advice about TSCA filings?
Hazardous Waste Experts offers you unparalleled expertise in all matters concerning the handling of hazardous materials—be they waste or virgin products—along with a comprehensive understanding of the regulations facing manufacturers of chemicals.
Get expert advice and help today concerning all aspects of EPA reporting requirements and EPA regulations.
Or call 877.200.2029.