Managing Compliance: Enhancing Chemical Management within the Framework of Existing TSCA Regulations

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 the last 2 years, momentum has been building for significant reform of the Toxic Substances Control Act (TSCA). In September 2009, EPA Administrator Lisa Jackson released a set of core principles to strengthen U.S. chemical management laws. Shortly thereafter, in April 2010, Senator Frank R. Lautenberg, D-N.J., introduced legislation to overhaul TSCA, dubbed the “Safe Chemicals Act of 2010.”

While it recently was speculated that a divided House and Senate would prevent any TSCA legislation from passing in 2011, a Feb. 3 Senate hearing to assess the effectiveness of U.S. chemical laws revealed that there still is strong support for TSCA reform.

“We are committed to being part of a bipartisan process to achieve modernization of TSCA,” said Cal Dooley, president of the American Chemistry Council, an industry group.

However, the path to reform likely will take some time. Even if a bill is passed this year, EPA still will need to go through a rulemaking process to promulgate any resulting regulations. This process could take some time, so any changes to the current chemical control law still are several months, if not years, away.

With this in mind, EPA has been working hard to enhance chemical management within the scope of the current TSCA regulations. A summary of these changes follows.

UNDERSTANDING ENHANCEMENTS

Following the 2009 announcement, EPA has been hard at work modernizing TSCA through the existing limits of the law. To date, they have released eight chemical action plans and are in the process of completing two more. The chemical action plan (CAP) indicates that the agency will be taking regulatory action through TSCA 5(a)(2), 5(b)(4) and 6(a) to increase requirements, restrict or ban numerous chemicals. Other notable enhancements include:

  • In January 2010, EPA announced that it would review confidentiality claims submitted under TSCA 8(e) to enhance the public's access to “critical health and safety information on chemicals.” Following this announcement, EPA published a statement that announced that it generally would deny confidentiality claims for the identity of chemicals in health and safety studies filed under TSCA “except in specific circumstances” and that confidential business information (CBI) was to be rejected.

    Chemicals affected by this action are those submitted to EPA with studies that show a substantial risk to human health and the environment and that previously have been disclosed on the TSCA Chemical Inventory. Under TSCA, companies may claim a range of sensitive, proprietary information as CBI. Under Section 8(e), companies that manufacture, process or distribute chemicals are required to immediately provide notice to EPA if they learn that a chemical presents a substantial risk of injury to health or the environment. Section 8(e) reports are made available on EPA's Web site. Until now, companies routinely claim CBI. The new policy will increase the amount of information available by granting public access to the chemical identification information submitted, along with other health and safety data under Section 8(e).

  • An announcement was made in May 2010 that EPA has performed a pilot program reviewing CBI claims submitted within the past 5 years. On Feb. 10, EPA notified five companies that 14 chemicals for which they had submitted confidential health and safety studies would be made public on the 31st day after the company receives the determination.

  • On Feb. 25, 2010, EPA published a proposed rule requiring testing on 29 high production volume chemicals. Following a public meeting in August 2010, a final rule was published Jan. 7 requiring manufacturers to submit data on 19 substances. This group of chemicals targets a wide variety of consumer and industrial chemical products. Data collected through TSCA Section 4 will allow EPA to obtain critical information and develop plans to mitigate risks as well as increase transparency by providing hazard characterizations to the general public.

    EPA also has made changes to IUR reporting to increase transparency and frequency. The rule currently states that reporting must occur every 5 years, but the proposed rule requires reporting every 4 years. This would provide consumers with an increased ability to determine which chemicals are being produced in their vicinity. The proposal also mandates electronic reporting, so the information will be available to the public faster and on a more consistent basis.

  • In March 2010, EPA launched its TSCA chemical inventory for free on the Web. This especially is notable as this is the first time that this inventory has been offered for free, and is part of a series of ongoing steps he agency is taking to empower the public with important information. The inventory contains a consolidated EPA list of thousands of industrial chemicals.

  • 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.


Erin McVeigh is a regulatory research analyst for 3E Co. and TONY HARRIS is a senior EHS compliance solutions engineer with 3E Co. Visit http://3ecompany.com for more information.

TAGS: Environment
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