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Understanding EPA Chemical Regulations (TSCA)

Posted by Teresa Stepan on Jun 14, 2023 7:43:01 AM

Understanding EPA Chemical Regulations (TSCA)

The EPA regulates substances that people and animals cannot consume or breathe in without risk of severe illness or death. Though this is a gross simplification, the statement illustrates how involved the EPA is in our daily lives and with our imports.

The EPA regulates these toxic chemicals and substances and imposes strict requirements on their import. As an importer, you must know if the EPA regulates your products and which regulations apply to them. 

Failing to accurately classify and declare chemical shipments entering the U.S. can violate Federal laws and lead to civil and criminal penalties. Understanding the origins of the EPA and its role in importing toxic chemicals and substances will help importers determine if their imports fall under EPA regulations.

History of the EPA

The government created the Environmental Protection Agency (EPA) in 1970 to combat environmental issues like unclean water and the impact of radioactive materials. 

In 1976, Congress passed the Toxic Substances Control Act (TSCA), which gave the EPA authority to gather information on chemicals, require manufacturers to test chemicals, and regulate chemical production and use. TSCA also required the EPA to create the TSCA Chemical Substance Inventory, which lists all existing chemical substances manufactured, processed, or imported into the United States that do not qualify for an exemption or exclusion under TSCA.

All imports of toxic or chemical substances and mixtures are subject to TSCA requirements. Non-compliance with TSCA can lead to detained shipments and/or denied entry and substantial civil and criminal penalties. 

Importers must supply a chemical certification statement indicating the product complies with TSCA rules or orders (a positive certification) or is not subject to TSCA rules or orders (a negative certification). 

A Customs broker can guide you to the correct declaration. You’ll be required to submit a paper form showing the product and certification type, and your Customs broker will then submit that information electronically with your entry.

What are Chemical Substances, Mixtures, and Articles?

To understand whether your product might fall under TSCA, you must first understand the difference between chemical substances, mixtures, and articles, which may or may not be covered by TSCA.

  • Chemical Substances. The EPA considers organics, inorganics, polymers and chemical substances of unknown or variable composition, complex reaction products, and biological materials as chemical substances. 
  • Mixture. Generally, mixtures are regulated by TSCA. A mixture is defined as any combination of two or more chemical substances. 
  • Articles. Articles are manufactured items formed to a specific shape or design during manufacture. A chemical substance is considered to be imported as part of an article if the substance is not intended to be removed from the article and has no end use separate from the article. Examples of articles include cigarette lighters, lighter fluid, automobiles, rolled carpets, sheets of plywood, molded plastic parts, instant photographic film, and finished fabric.

Items not considered articles or parts of articles that are subject to TSCA reporting can include ink in pens, caulk in canisters, substances or mixtures in aerosol cans, lighter fluids in refill cans, bulk metal raw material imported in a shape suited for importing convenience, bulk plastics that can be converted into finished plastic articles, scrap metal, paints, inks, and adhesives. 

How Do You Know If Your Product is Subject to TSCA?

Checking the TSCA Chemical Substance Inventory is the best way to learn whether your product is subject to TSCA.

The TSCA Inventory contains all existing chemical substances manufactured, processed, or imported into the United States that do not qualify for an exemption or exclusion under TSCA. Chemical substances not on the Inventory are those with uses not regulated under TSCA.

A chemical on the Inventory is considered an existing chemical substance in U.S. commerce. If a chemical is not on the Inventory, it is considered a new chemical substance. To determine whether a substance is new or existing, the Inventory flags existing chemical substances subject to manufacturing or use restrictions. 

Determining whether a chemical belongs in the Inventory before manufacturing a chemical substance is important. Any company hoping to manufacture a new chemical substance must supply the EPA with a Pre-Manufacture Notice (PMN) at least 90 days before initiating the activity. 

There is a public version of the TSCA Inventory, but not every chemical or toxic substance is shown. Due to confidentiality concerns, some products fall under the Confidential Business Information Rule; as a result, if you do not see a product on the public TSCA Inventory, you may need to ask the EPA to search the record for you.

Importers can submit an Intent to Manufacture or an Import Notice to get a written EPA determination for your product. The EPA will consider your information and search the full TSCA database, then provide written notice of whether the product is subject to TSCA rules. 

If the EPA says your product isn’t subject to TSCA, you can submit a PMN for a new chemical or intent to manufacture a chemical for a nonexempt commercial purpose. After you submit the PMN, you must submit a Notice of Commencement (NOC) of manufacture and import within 30 days of import or manufacture. Once you submit a completed NOC, the reported substance will appear in the TSCA Inventory and become an existing chemical. 

The EPA receives around 400 NOCs every year, which means the TSCA Inventory changes nearly every day. Every time you import a product, you must check the database— a product that wasn’t in the database yesterday could be there today.

What are SNURs and SNUNs?

A SNUR is a Significant New Use Rule for chemical substances. 

To determine whether a chemical is subject to a SNUR, check the TSCA Inventory. The Inventory will denote chemicals subject to a SNUR with an “S'' flag in the listing. If your chemical substance needs a SNUR and you intend to process, manufacture, or use the substance in new ways, you need to submit a SNUN, or Significant New Use Notice, 90 days prior to manufacturing the substance.

Importers must submit a SNUN to the EPA for the agency to determine if a SNUR is required. 

How Does the EPA Regulate Goods Containing Formaldehyde?

In 2016, the EPA enacted Title VI to regulate goods containing formaldehyde. This legislation targets composite wood products created using adhesives that contain formaldehyde. 

Targeted articles include: 

  • Hardwood plywood
  • Particle board 
  • Medium-density fiberboard

These products must be labeled as TSCA Title VI compliant.

Title VI products require the transmission of a positive certification if the article is subject to regulation. Otherwise, EPA Title VI can be disclaimed. Information that must be transmitted with the entry includes the name, telephone number, and email address of the party certifying the products.

TSCA Forms

A.N. Deringer, Inc. has a new TSCA form to help clients with these imports. A separate Title VI form is also available. The forms are found under Resources and Forms on the A.N. Deringer, Inc. website. 

Remember, it is your responsibility to know the goods you are importing and to provide correct information on the necessary importing forms. 

Making a false declaration can violate the law. Be aware of what you’re signing and have the knowledge to make the certification—to ensure compliance, partner with an experienced Customs broker.

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