TSCA: Comprehensive Chemical Regulation in the US

The first serious initiatives to regulate toxic chemicals began in the early 1970s. The newly formed President’s Council on Environmental Quality drafted a chemicals bill to address concerns around potentially dangerous chemicals. As a result, the Toxic Substances Control Act (TSCA) was created to provide controls for those chemicals that may threaten human health or the environment.

What is the Toxic Substances Control Act (TSCA)?

TSCA is a comprehensive federal environmental regulatory scheme covering the manufacturing, distribution, sale, and use of all chemical substances. TSCA provides the US Environmental Protection Agency (EPA) with full legal authority to gather environmental, health, and safety (EHS) information and to require research regarding chemical substances of potential concern. TSCA protects human health and the environment by, among other things, authorizing EPA to issue rules requiring the testing of specific chemicals and to establish regulations that restrict the manufacturing, processing, distribution in commerce, use, and disposal of chemicals and mixture.

TSCA History and Background

The Toxic Substances Control Act (TSCA) became law on October 11, 1976, and became effective on January 1, 1977. TSCA (often pronounced “tosca”) was crafted in response to Congress’s growing concerns about the unreasonable risks that chemicals pose to human health and the environment. TSCA limits the manufacture, processing, commercial distribution, use, and disposal of chemical substances including PCBs, asbestos, radon, and lead-based paint.

TSCA gives the EPA the ability to track close to 100,000 industrial chemical substances produced in or imported into the United States. Congress later added additional titles to the Act, with this original part designated Title I – Control of Hazardous Substances.

Updates to the Law

In 2016, TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act to update and modernize the badly outdated chemical safety law. The Lautenberg Chemical Safety Act added many important updates to the TSCA legislation, including:

• Mandates the evaluation of existing chemicals with clear and enforceable deadlines
• Requires development of risk-based chemical assessments
• Increases public transparency for chemical information
• Provide consistent funding for the EPA to carry out responsibilities under the new law

Current titles of TSCA include:

1. Title I – Control of Toxic Substances
2. Title II – Asbestos Hazard Emergency Response
3. Title III – Indoor Radon Abatement
4. Title IV – Lead Exposure Reduction
5. Title V – Healthy High-Performance Schools
6. Title VI – Formaldehyde Standards for Composite Wood Products

TSCA Requirements

TSCA requires the EPA to determine whether a chemical is likely to meet the safety standard before it enters the market.

TSCA compliance can require companies to restrict and remove substances from products to maintain U.S. market access. Section 6 of TSCA contains special import and export requirements for certain chemicals like PCBs, mercury, asbestos, and lead. The EPA has required testing of only about 200 of these grandfathered chemicals, and it has banned only five chemicals or chemical groups.

Section 8(e) of TSCA requires manufacturers, importers, processors, and distributors of chemicals to notify 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.

Self-Certification of Imported Chemicals

Under U.S. Customs and Border Protection (CBP) regulations implementing TSCA section 13, importers are required to self-certify that imported chemicals either comply with TSCA (positive certification) at the time of import, or if they are not clearly identified as excluded from TSCA, are not subject to TSCA (negative certification).

The EPA defines “importer” to include the person primarily liable for the payment of any duties on the merchandise or an authorized agent, the consignee, the importer of record, or the actual owner.

Summary of Requirements

To remain compliant with TSCA regulations, companies should focus on the following

• Companies must document the use of restricted substances in parts, materials, and products
• EPA requires document retention for three years
• Companies must communicate the presence of any banned substances used in a product to customers
• Companies should also evaluate supply chain risk for consumables and maintenance parts used for U.S.based manufacturing warehouse operations that may contain these substances Eg: Fork-Lifts, (Hydraulic fluid gaskets, seals etc.) ;  Eg: Miling and grinding Machinery

Chemicals Subject to TSCA Restrictions

TSCA applies to manufacturers, importers, and processors of chemical substances. TSCA covers any new or existing commercial chemical substances and mixtures. TSCA requires that the EPA be notified at least 90 days before the manufacture or import of a new chemical substance for commercial purposes. Accordingly, food packaging is excluded from TSCA’s definition of chemical substances.

TSCA currently fully or partially restricts 14 substances or substance families:

• Asbestos
• Lead (in paint and paint waste)
• Polychlorinated biphenyls (PCBs)
• Dioxins
• Chlorofluorocarbons (CFCs)
• Metallic mercury (in consumer products)
• Formaldehyde
• Nitrites (in metalworking fluids)
• Hexavalent chromium compounds (on metals used in water treatment)
• Phenol, Isopropylated Phosphate (3:1) (PIP 3:1)
• Decabromodiphenyl ether (DecaBDE)
• 2,4,6-Tri-tert-butylphenol (2,4,6 TTBP)
• Hexachlorobutadiene (HCBD)
• Pentachlorothiophenol (PCTP)

In January 2021, the EPA added the final five substances under Section 6(h) of TSCA. The agency set an aggressive timeline for companies to scope their supply chain, communicate the presence of the restricted substances to customers, and find alternatives to their use. Manufacturers have obligations from March 8, 2021, onward, and distributors will be brought into scope on January 6, 2022, for some substances.

Exemptions

Most toy companies are exempted from the TSCA Risk Evaluation Fees and Self Identification Rule. Any chemical substance is exempted from many of the requirements of TSCA when it is imported, produced, or used in small quantities, and solely for purposes of non-commercial scientific experimentation, analysis or research, and under the supervision of a technically qualified individual.

Chemicals that are NOT Subject to TSCA Regulation

Many materials are not required to be reported under TSCA because they are regulated by other legislation and government agencies. Reporting is not required for pesticide products, drugs, food, food additives, cosmetics, medical devices, nuclear materials, and quantities of substances imported or manufactured solely for research and development. Below are some examples of materials that are regulated outside of TSCA:

• Pesticides regulated by FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act)
• Tobacco and tobacco products regulated by ATF (Bureau of Alcohol, Tobacco, Firearms and Explosives)
• Radioactive materials regulated by NRC (Nuclear Regulatory Commission)
• Foods, food additives, drugs, cosmetics, or devices regulated by the FDA (Food and Drug Administration)

Evaluating Risk Management

EPA has recently announced the first 10 chemical substances that it will evaluate for potential risks to human health and the environment under TSCA:

• 1,4-Dioxane
• 1-Bromopropane (1-BP)**
• Asbestos
• Carbon Tetra Chloride**
• Cyclic Aliphatic Bromide Cluster (HBCD)**
• Methylene Chloride (MeCl)**
• N-Methylpyrrolidone (NMP)**
• Pigment Violet 29 (PV 29)
• Trichloroethylne (TCE)
• Tetrachloroethylene (Perc)

** Final risk evaluation includes electronics-related conditions of use.

The EPA published five final rules on January 6, 2021, impacting substances, mixtures, and articles containing these restricted substances:

• Phenol, Isopropylated phosphate (PIP 3:1), CAS No. 68937-41-7 – Flame Retardant and plasticizer
• Decabromodiphenyl ether (DecaBDE), CAS No. 1163-19-5 – Flame Retardant
• 2,4,6-tris (tert-butyl) phenol (TTBP), CAS No. 732-26-3 – Antioxidant, Lubricant, and fuel additive
• Hexachlorobutadiene (HCBD), CAS No. 87-68-3 – Hydraulic, Heat transfer, or transformer fluid
• Pentachlorothiophenol (PCTP), CAS No. 133-49-3 – Plasticizer

Factors Influencing Toxicity

In some instances, individuals can have unpredictable reactions, or idiosyncratic responses, to a drug or other substance. An idiosyncratic response is uncommon, and it is sometimes impossible to understand whether it is the result of a genetic predisposition or has some other cause such as the status of the immune system. It could result in an abnormally small or short, or abnormally large or long response to the drug or other substance. Or, the response could be qualitatively different than what has been observed in most other individuals.

The toxicity of a substance usually depends on the following factors:

• Form and innate chemical activity
• Dosage, especially dose-time relationship
• Exposure route
• Species
• Life stage, such as infant, young adult, or elderly adult
• Gender
• Ability to be absorbed
• Metabolism
• Distribution within the body
• Excretion
• Health of the individual, including organ function and pregnancy, which involves physiological changes that could influence toxicity
• Nutritional status
• Presence of other chemicals
• Circadian rhythms (the time of day a drug or other substance is administered).

Although there are over 80,000 chemicals on the market in the US, EPA has only banned nine.

Conclusion

TSCA is among the earliest and broadest legislation regulating the manufacture, sale, and use of chemicals in the United States. Major updates to the law in 2016 helped modernize chemical regulation and clearly communicate risk to the public. As the EPA continues to refine safety standards and risk assessments, companies are obligated to evaluate and report a great deal of information about the chemicals they use and produce.