EPA Seeks to Enhance Public Access to Chemical Data
The U.S. Environmental Protection Agency (EPA) has proposed several changes to its regulation of chemicals that should improve the public's access to crucial information. The improved data collected under the proposed rule will help the agency and the public identify potential chemical risks and take action to manage those risks.
The proposed rule is the latest of several actions by the EPA to use its existing authority under the nation's primary chemical law, the Toxic Substances Control Act (TSCA), to improve the public's access to chemical data and prevent manufacturers from inappropriately hiding health and safety information as alleged trade secrets.
The proposed changes would affect the Inventory Update Reporting (IUR) rule under TSCA. Under TSCA, EPA compiles an inventory of chemical substances in commerce in the U.S., known as the TSCA Chemical Substance Inventory (TSCA Inventory). The IUR rule updates the TSCA Inventory by collecting updated information on volumes of chemical production, manufacturing facility data, and how the chemicals are used. The IUR provides exposure-related data needed to understand chemical risks – information that is vital to identifying chemical risks to the public and environmental health and crafting regulations to protect them.
According to EPA, "The IUR data are used to support risk screening, assessment, priority setting and management activities and constitute the most comprehensive source of basic screening-level, exposure-related information on chemicals available to EPA." The agency uses IUR data "to support many health, safety, and environmental protection activities."
Under President George W. Bush, the EPA weakened TSCA reporting by raising the reporting threshold, which was originally 10,000 pounds, and reducing the frequency of reporting from every four years to every five.
The proposed rule lowers or eliminates thresholds for reporting and increases reporting frequency, moves that should provide the public with more information on more chemicals. The amount of a chemical manufactured at a facility in any given year fluctuates widely. Currently, manufacturers must report if during the "principal reporting year," which actually occurs every five years, the production volume of a chemical exceeds 25,000 pounds. EPA's proposed rule would require a manufacturer to submit information on a chemical if the volume exceeds the 25,000-pound threshold for any year since the previous submission. The agency is also proposing to return the reporting frequency to every four years rather than every five. Additionally, EPA is proposing requiring all reporters to submit data on the processing and use of the chemicals. The current program requires such reporting only for chemicals manufactured or imported over 300,000 pounds.
Chemical manufacturers and importers will be required to report the information electronically. EPA will provide manufacturers with access to electronic reporting software and additional guidance on how to report electronically. Only one-third of reports were submitted electronically in the last reporting year, 2006, and EPA took over two years to validate the data submitted in paper or CD-ROM formats. A large number of errors were generated by entering data by hand into agency computers. By requiring electronic submissions over the Internet, EPA hopes to greatly reduce the reporting errors and get the data out to the public in a timelier manner.
Another proposed change would require reporting of a number of valuable pieces of information, such as yearly production volumes, more specific chemical names and numbers to ensure the correct chemical substances are identified, and the approximate number of workers exposed to the chemicals.
Important changes to the agency's treatment of trade secret claims have also been proposed in the rule. Currently, manufacturers are allowed to label data as confidential business information (CBI) with nearly no limitations, which usually compels the agency to withhold such information from the public. EPA has acknowledged that the inappropriate and excessive use of CBI claims has hidden important information from the public and even from EPA offices. According to the agency, "The public would be better informed and better able to understand and provide meaningful comment on Agency actions if less information were unnecessarily or inappropriately claimed as CBI. The Agency would also be able to provide other public and private organizations and individuals with better information for making their own decisions."
The agency will place limits on what a manufacturer can label as CBI when submitting data under the IUR rule. EPA intends to prohibit use of CBI claims for the identity of a chemical listed in an IUR submission if the chemical identity is already publicly available on the public portion of the TSCA Inventory. EPA also proposes requiring upfront substantiation for CBI claims for processing and use information. Submitters would have to supply the agency with written explanations defending their CBI claims. Manufacturers have previously claimed data to be CBI even though the same data were available publicly elsewhere – such as on the company's website.
The recent proposed rule follows several other actions by EPA to limit the abuse by chemical manufacturers of trade secrets protections. In May, EPA issued a "general practice" restricting CBI claims on chemical identities that are part of a health or safety study. In January, EPA announced chemical identities could not be considered CBI when manufacturers submit information indicating a chemical substance or mixture presents a substantial risk of injury to health or the environment if the chemical identity is already on the public portion of the TSCA Inventory.
According to Steve Owens, the EPA's assistant administrator for the Office of Chemical Safety and Pollution Prevention, "Enhanced reporting on the production and use of chemicals will help give the American people greater access to information on the chemicals to which their children and families are exposed every day."
EPA is now accepting public comments on the proposed rule. EPA expects to finalize the modifications to the chemical information reporting rule in time for the next reporting period, scheduled for June 1-Sept. 30, 2011, for chemicals manufactured during calendar year 2010.