The Toxic Substances Control Act is an environmental law, administered by the US EPA, which monitors new and existing chemicals. This Chemical Substances Inventory was put together to assess chemicals for possible health hazards and also, to supervise their distribution and use. Chemicals that are not present in the inventory are prohibited from manufacturing and import. Generally, manufacturers must notify EPA before manufacturing/ importing new chemicals in the marketplace. In 2016, amendments were made to TSCA when the Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed. The need to prevent “unreasonable risk” has increased thus far, along with the EPA’s authority to demand more chemical information.

Under the Frank R. Lautenberg, Chemical Safety for the 21st Century Act, five rules about exposure levels of persistent, bioaccumulative, and toxic (PBT) chemicals were issued by the EPA on January 6th, 2021. Section 6(h) of the TSCA requires EPA to take immediate action against PBT chemicals, addressing the risks posed by these chemicals due to exposure.

*5 PBT chemicals requiring special attention were pointed out by the EPA in 2016, followed by a proposed rule in 2019. The final legislative rule was published earlier this year.

● Decabromodiphenyl ether (DecaBDE), used as flame retardants in the electronics industry, is prohibited for manufacture (including import), processing, and distribution. Provision for exemptions is given in the hospitality industry, nuclear power generation facilities, aerospace vehicles, motor vehicles, plastic shipping pallets, and in the recycling of plastic.

● Phenol, isopropylated phosphate (PIP 3:1) is used in a variety of applications. They could act as a plasticizer or a flame retardant, an anti-wear additive, or an anti-compressibility additive. On the flip side, PIP (3:1) is highly toxic to the aquatic ecosystem. It is exempted for use in military applications, lubricants and greases, locomotive and marine applications, in the recycling of plastic that contains PIP (3:1), etc.

● 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP) is extensively used as a fuel additive. Similar to PIP (3:1), 2,4,6-TTBP is lethal to aquatic flora and fauna. The restriction limit for this chemical is set at 0.3% by weight (for a container with a volume lesser than 35 gallons) when used as a fuel additive. For lubricative applications, concentrations shouldn’t exceed 0.3% by weight regardless of container size. 

● Hexachlorobutadiene (HCBD) is a byproduct of the production of chlorinated hydrocarbons such as perchloroethylene, trichloroethylene, and carbon tetrachloride. It is burnt as waste fuel. EPA is granting immunity for HCBD only when it is produced as a byproduct from the manufacturing of chlorinated hydrocarbons as mentioned above, and for burning as a waste fuel.

● Pentachlorothiophenol (PCTP) is used in making rubber more flexible. Due to its hazardous nature, EPA is allowing usage of PCTP in articles only at concentrations of 1%. 

APA Engineering with over 20+ years experience in ‘Product Chemical Compliance’ & Global client base has built a Web-based SaaS platform, GreenCheck, to reduce costs & time and achieve comprehensive compliance reporting. We help the organization meet all the regulatory requirements imposed by the US EPA under TSCA.

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Offering compliance solutions in a diverse list of regulatory compliances, including IMDS/CAMDS, REACH/RoHS, SCIP, Conflict Materials, and much more.

*For more details on the recent PBT rules, visit this site!

If this regulation is applicable to you and you are interested in knowing more about this topic and available solutions, then schedule a free consult with our experts.