Amidst continued concern that the Toxic Substances Control Act (TSCA) is ineffective, the EPA will attempt to use the Act to the fullest extent possible until it can be reformed. Since the Act came into effect in 1976, the agency has used TSCA to restrict or ban only five of the 84,000 chemicals currently on its inventory. The EPA has required testing on another 200 chemicals. Taking note of its past failures, the EPA is expected to strengthen chemicals management under TSCA. As a result, companies may be subject to greater scrutiny for compliance with Pre-Manufacture Notice (PMN) requirements, increases in the PMN review fee, restrictions on phthalates, new limits on claims of confidential business information and increased enforcement inspections and agency actions.
In February 2010, the EPA proposed specific areas to enhance its chemicals management program in response to a report from the EPA’s Office of Inspector General (OIG), The OIG report notes that 87% of chemicals that are the subject of a Pre-Manufacture Notice (PMN) go unregulated. This high percentage is largely due to a lack of meaningful data in PMNs. Half of PMNs contain no test data while 85% contain no toxicity data. Generally where data is incomplete or limited, the EPA reports the new chemical as having no risk. The report accredits this failure to a lack of funding and inability to coordinate existing information about chemical hazards. The EPA also notes that the Department of Treasury must allocate greater funding to PMN review. To increase the flow of information, the EPA plans more collaboration between the two offices affecting chemicals management- the Office of Prevention Pesticides and Toxic Substances (OPPTS) and the Office of Enforcement and Compliance Assurance (OECA). The two offices are currently working on a better TSCA compliance and enforcement strategy. The offices are also compiling a database of information about regulated companies.
In late December 2009, EPA announced that it will use its authority under TSCA to identify hazards for four chemicals: phthalates, long-chain perfluorinated chemicals (PFCs), polybrominated diphenyl ethers (PBDE’s) in products, and short-chain chlorinated paraffins (SCCP’s). These chemicals are used in a variety of products including coatings in pills, paints, inks, cosmetics, toys, household products and medical devices. The EPA will begin rule-making procedures later this year that may result in a ban or restricted use of the four chemicals.
The EPA has also proposed a rule requiring manufacturers to perform specified tests on 29 high process volume (HPV) chemicals. If enacted, the EPA will use the data to support development of preliminary hazard and risk assessments that could result in further restrictions.
In an effort to promote greater public access to information, the EPA has limited the scope of Confidential Business Information (CBI) claims for health and safety studies submitted under Section 8(e) of TSCA for chemicals already listed on the public portion of the TSCA Chemical Substance Inventory. Previously, the EPA would redact chemical names claimed as CBI even where the chemical is listed in the public portion of the inventory.
Congress is expected to strengthen the EPA’s ability to manage chemical risk by requiring better screening before chemicals reach the market. Draft legislation requires manufacturers of new chemicals to demonstrate safety prior to placing chemicals on the market. Draft provisions also require companies to submit additional risk information for the 84,000 chemicals currently on the TSCA inventory, while requiring the EPA to evaluate information and make safety determinations.
As a result of the EPA efforts under the existing TSCA and expected future reforms, companies can expect to see several changes that could result in increased enforcement, restrictions and testing requirements.