TSCA Compliance: A Complete Guide

Overview

The TSCA is crucial in regulating chemical hazards in the United States. It has been refined over the years to ensure that it addresses continuously evolving challenges and upholds global sustainability goals. Here is a quick background about the regulation:

Why was the Toxic Substances Control Act Created?

The world has seen a growing incidence of environmental issues resulting from the boom in industrial chemical manufacturing following the Second World War. The Centralia mine fire in Pennsylvania, the Tennessee gas pipeline explosion in Louisiana, and the Los Angeles O’Connor plating work disaster were problematic incidents that must be curbed or eradicated.

In 1976, the United States passed the Toxic Substances Control Act, changing the weak and ineffective law that assumed chemicals were safe until they caused harm.

Unfortunately, chemical risks continued to grow.

In 2016, the US enacted the Frank R. Lautenberg Chemical Safety for the 21st Century Act, updating and significantly strengthening the TSCA regulation.

Who Enforces The Law?

The Environmental Protection Agency (EPA) is the primary enforcer of the regulation. The office has the broad authority to conduct inspections, issue subpoenas, and impose penalties on companies that do not comply. Other agencies work with them to ensure every detail in the law is administered:

• Occupational Safety and Health Administration (OSHA)
• Consumer Product Safety Commission (CPSC)
• Food and Drug Administration (FDA)
• Office of Chemical Safety and Pollution Prevention (OCPP)
• Treasury Department

What Chemicals are Regulated Under the TSCA?

The EPA has defined chemicals as any natural or man-made substances with a specific molecular makeup. These chemicals include mixtures from chemical reactions, naturally occurring ones, and any element or single-atom groups. Here are six chemical substances that receive special attention:

• Polychlorinated Biphenyls (PCBs)
• Asbestos
• Radon
• Lead
• Mercury
• Formaldehyde

Who is Subject to this Regulation?

The regulation applies to various entities. All listed below are responsible for complying to ensure public health and safety and environmental protection:

• Manufacturers and processors of chemical substances
• Importers
• Exporters and Distributors
• Commercial and other downstream users
• Federal facilities (e.g., government buildings and military bases)
• Individual state agencies and offices

The key personnel in companies responsible for collecting vital data and compiling them into reports for submission to the EPA are the following:

• Environmental compliance officers
• Regulatory affairs specialist
• Health and safety officers
• Corporate legal teams

Significance

Regulating hazardous substances ensures that chemical exposures that cause diseases (e.g., cancers, reproductive disorders, respiratory problems, etc.) are minimized or eradicated. It also prevents environmental contamination that negatively affects ecosystems and biodiversity.

Organizations that strictly comply with TSCA regulations gain numerous benefits as well. Apart from ascertaining market access and enhancing their reputation among investors and consumers, they also learn how to proactively manage risks, drive innovation, and ensure business sustainability.

Key Provisions

TSCA compliance is challenging because of its complexity. Aside from the fact that there are numerous chemicals covered, conducting regular evaluations and maintaining accuracy are time-consuming and resource-intensive. Understanding the regulation and knowing the specific requirements can help:

Chemical Data Reporting

All companies subject to TSCA regulation should provide detailed information about the chemicals they produce, import, and distribute. The report should include volume, use, and potential exposures.

Best Practices:

• Ensure data is accurate and submitted within the set timeframes.
• Continuously update chemical inventories and reports, reflecting changes in production, usage, and hazard information.
• Utilize the E-CDRweb reporting tool. The site, made available in June 2024, is now accessible.

Pre-Manufacture Notification (PMN)

Before manufacturing or importing any new chemical substance, the company should file a pre-manufacture notice 90 days in advance. This report enables the EPA to evaluate chemical safety, review the potential risks, and, if necessary, prevent them from entering the market.

Best Practices:

• Conduct comprehensive internal assessments before submission to the EPA.
• Submit the documentation early to address any potential concerns or additional requests.

Risk Evaluation and Management

The company should conduct risk evaluations in conjunction with the EPA. If risks are identified, managers should be ready with management and mitigation strategies, including proper storage, waste disposal, and possible substitution, to name a few.

Best Practices:

• Regularly evaluate the safety of chemicals used in operations to identify and mitigate risks early.
• Develop health and safety procedures for inspections, hazard analysis, issues reporting, and incident investigations.
• Involve stakeholders (e.g., employees, customers, and community members) to ensure they also understand the risks and have knowledge in identifying and addressing issues.

Significant New Use Rules (SNURs)

Companies should notify the EPA before using any chemical substance or mixture in new ways. Similar to the PMN, the SNUR filing should be done at least 90 days before manufacturing, importation, or processing.

Best Practices:

• Monitor and document any proposed new use of chemicals as early as possible so the EPA can be notified before the time frame provided.
• Provide detailed justifications and risk assessments to help EPA with their review and decision-making.

Recordkeeping and Reporting of Adverse Effects

EPA mandates detailed record-keeping of the chemicals’ adverse effects. Aside from the general purpose of the regulation, this documentation encourages companies to adopt best practices, enhancing chemical safety measures and reducing dangerous workplace incidents.

Best Practices:

• Implement and maintain robust recordkeeping systems. Using digital templates stored in centralized repositories will benefit employees as it simplifies the task and ensures accuracy.
• Establish continuous monitoring processes to detect and document adverse effects as they occur, ensuring proactive responses.
• Report any significant events related to these adverse effects to the EPA.