Since its promulgation in 1976, the Toxic Substances Control Act (TSCA), which is administered by EPA, has focused on human health and the environment, with the overarching goals of evaluating risks and assessing human health and environmental effects before a chemical is introduced into commerce.
In May 2010, EPA added 6,300 chemicals and 3,800 facilities to the Envirofacts database, which is Internet accessible and provides information about environmental activities that may affect air, water and land. The database also provides tools for analyzing the data and includes facility name and address information, an aerial image of the facility and surrounding area and the map location of the facility. In addition, the database links to other EPA information on the facility, such as EPA's inspection and compliance records that are available through the Enforcement Compliance History Online (ECHO).
The December 2010 availability of the Chemical Data Access Tool, which is used to find health and safety data that has been submitted to the agency under authorities in sections 4, 5 and 8 of TSCA. Some of this data is being provided to the general public for the first time with the hopes that as the agency collects more information the search tool will continue to grow and will help to streamline access to a broad range of chemical health and safety data.
On a state level laws have been passed to phase out or ban specific substances; proposed comprehensive chemical state initiatives and even resolutions from states calling on congress to reform TSCA.
EXPLORING THE IMPACT ON BUSINESS
Many companies will be affected by these changes, as almost every business involved in the chemical industry is impacted by TSCA in some way (with some exceptions among food, drug, cosmetic, nuclear and pesticides companies). In addition, raw materials, intermediates and finished goods are regulated by TSCA. Full lifecycle, or cradle-to-grave, compliance is an essential component of TSCA, and most manufacturing/importing, processing and disposal activities are TSCA regulated. If companies do not comply with TSCA, they could face severe legal repercussions, including criminal and civil penalties, damage to the brand or company reputation and negative impact on a company's ability to do business. Personnel that demonstrate willful and knowing non-compliance also face imprisonment.
The risk of financial damage also is high if a company is non-compliant, as non-compliant companies may receive fines and penalties and experience a loss of business revenue if production is stopped.
The penalties for non-compliance are severe, and companies found to be non-compliant can face penalties up to $37,500 per day or imprisonment for up to 1 year, or both. There also is a 5-year statute of limitations, and criminal penalties for “knowing” or “willful” violations can be imposed in lieu of, or in addition to, civil penalties.
In addition, as more and more states pass legislation to ban or restrict chemicals on a case-by-case basis, industry will continue to be burdened by this patchwork of regulations that ultimately will have a negative affect on development, production and sales. Currently, states are preempted by TSCA authority, but it has been proposed to remove this provision. This would allow states to impose different requirements from that of the federal act. A lack of regulatory uniformity could be quite burdensome to industry.
PREPARING FOR IMMINENT CHANGE
To ensure compliance with TSCA, experts recommend developing and maintaining a comprehensive and detailed plan, which should include the following:
- Checking the TSCA inventory for substances imported or manufactured, including the ingredients in finished products;
- Reviewing individual state regulations for banned or restricted substances;
- Reviewing TSCA R&D exemption requirements and setting up procedures to govern related activities;
- Obtaining import certification once the status of the substance or product to be imported has been checked against the TSCA inventory;
- Establishing processes for tracking 12(b) exports and assisting with export notification;
- Establishing processes for compliance with adverse effects reporting and recordkeeping;
- Monitoring and tracking regulatory changes that are likely to impact business; and
- Maintaining required records and auditing against various recordkeeping requirements.
Chemical companies also should consider becoming more involved in the reform movement, possibly through industry association such as SOCMA, the ACC or SCHC.
It also is important to note that legislators are beginning to take action on a state level and that many bills are passing quickly and quietly on this level. While the promulgation of the Safe Chemicals Act would ensure some consistency on a federal level, many states now are passing the various elements of the act on an individual basis. It is imperative for companies to closely monitor the chemical control laws for the states in which they conduct business.