US EPA Proposes Strict New Chemical Reporting Rules
The EPA and U.S. manufacturers and distributors are looking at more stringent chemical reporting requirements. See the Supply Chain Data Management article on the original press release last week.
This proposed action is the latest Environmental Protection Agency or EPA effort to expand enforcement of the existing Toxic Substances Control Act or TSCA. The proposal is that companies moving at least 11.3 metric tons of TSCA-inventory chemicals must retroactively report the activity for the past four years and report same going forward. The rule is expected to be implemented in 2011.
The proposed rule is based on the Inventory Update Reporting provision of TSCA.
- importing, or
25,000 pounds (11.3 tonnes) or more of any chemical, substance, mixture or chemical-cocktail in the TSCA inventory would have to report that activity.
The Office of Pollution Prevention and Toxics says:
"Under the proposed reporting rules, a company producing or importing 25,000 pounds (11.3 tonnes) or more of any chemical on the TSCA inventory would have to report that activity. For the 2011 Inventory Update Reporting or IUR, [companies would] report that activity when the threshold amount was reached or exceeded in 2010. For future IURs, [companies would] report that activity for any year of the most recent four years in which the threshold amount was reached or exceeded (i.e., for 2015 IUR consider production and import for 2011, 2012, 2013, and 2014)."
So, in the future, companies would be asked to report such activity for any year of the most recent four years in which the threshold amount was reached or exceeded.
"This may sound boring," noted EPA and regulations watchdog Dan Rosenberg, "but it is an important effort by EPA to get a better handle... on the amount of chemicals being produced (including imported) in this country, what they are being used for, and who is potentially being exposed to them." It doesn't sound boring at all to companies or environmental interests who are affected.
Notably, the proposed changes would make all inventory reporting electronic. This means the elimination of paper document filing. Software for chemical substance reporting will be used instead. The idea is to speed the reporting process.
In addition to chemical manufacturers and refiners, the proposed rules changes would apply to electric utilities, paper and metals manufacturing and the producers of semiconductors and other electronic components, according to the EPA. The EPA said the changes - scheduled to take effect in 2011 - would manifest four goals: better data for agency regulators, broader public access to industry reports, new information on potential exposures, and improved usefulness of information provided.
The Toxic Substances Control Act (TSCA) Inventory Update Reporting (IUR) rule enables EPA to collect and then make public critical information on the manufacturing, processing, and use of commercial chemicals. This includes current information on volumes of chemical production, manufacturing facility data, and how the chemicals are used. This information, obviously, helps EPA determine whether chemicals may be dangerous to people or the environment.
With that in mind, EPA proposes to amend the TSCA IUR rule to improve information for EPA so the agency can do its job of identifying and managing risks to the public associated with chemical substances, cocktails, and mixtures (referred to hereafter as chemical substances).
Additionally, with the amendment improved information would be publicly available.
The IUR rule, promulgated under TSCA section 8(a), requires manufacturers (including importers) of certain chemical substances on the TSCA Chemical Substance Inventory (TSCA Inventory) to report information about the manufacturing (including import), processing, and use of those chemical substances. EPA is proposing to require electronic reporting of IUR information and to modify IUR reporting requirements, including certain circumstances that trigger reporting, the specific data to be reported, the reporting standard for processing and use information, and Confidential Business Information (CBI) reporting procedures. These modifications aspire to provide information to better address Agency and public information needs, improve the usability and reliability of the reported data, and make data available in a timely manner.
Thresholds - how much is too much?
In 2006, when EPA enforced the current rule, the Agency believed a 300,000 lb. per year site-specific reporting threshold would capture sufficient exposure-related information for substantially all HPV chemical substances. However, based on the 2006 data, approximately 23% of the reports submitted for known HPV chemical substances had reported production volumes below the 300,000 lb. threshold, and consequently did not contain exposure-related processing and use information. Therefore, EPA believes that the 300,000 lb. threshold was too high to provide sufficient processing and use data for the HPV chemical substances.
The Agency explored setting the threshold for reporting processing and use information to an alternate level between the basic reporting threshold of 25,000 lb. and 300,000 lb. for this action; EPA now requests comment on alternate levels. However, the need to complete characterizations for chemical substances manufactured (including imported) in volumes of 25,000 lb. to 300,000 lb. in any year led EPA to believe that it would be best to eliminate the upper threshold and collect full information for all reported chemical substances.
Elimination of the 25,000lb threshold would be proposed for some, particularly concerning, chemical substances. The usual suspects, for more see the RoHS and SVHC lists.
Recap: Under the proposed reporting rules, a company producing, importing or using 25,000 pounds (11.3 tonnes) or more of any chemical or substance in the TSCA inventory would have to report that activity for any year of the most recent four years in which the threshold amount was reached or exceeded.
The agency has invited comment on the proposed changes by stakeholders and the general public, with the 60-day comment period ending in mid-October. For reference, the complete 53-page document called "TSCA Inventory Update Reporting Modifications; Proposed Rule" is available from the EPA website.
The proposal would require inventory update reporting every four years, rather than the current five-year reporting frequency.
Related Reporting News: Tox21
Established in 2008, the Tox21 collaboration merges U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) and the Food and Drug Administration (FDA) for chemical awareness. FDA's involvement will provide additional expertise and chemical safety information to improve the chemical testing methods presently in use. Tox21 will make current chemical testing methods more viable, more comprehensive, and, hopefully, more efficient and effective.
“Through the Tox21 collaboration," said Dr. Paul Anastas, assistant administrator for EPA’s Office of Research and Development. "2,000 chemicals have already been screened against dozens of biological targets and we are working to increase the number of chemicals to 10,000 by the end of the year .” - July 19, 2010
There are tens of thousands of chemicals currently in commerce; current chemical substance metrics collection and tracking and reporting is expensive and time consuming. There has to be a better, safer way. A streamlined set of regulations and reporting mechanisms aspires to lean the entire business -- and pleasure! -- of the critical chemical portion of manufacturing. The ACC, too, expressed agreement with the sentiment that better chemical-substance regulations are needed.