On August 2, 2011, the US Environmental Protection Agency (EPA) issued the final Chemical Data Reporting (CDR) Rule, which requires certain entities involved in the manufacture of chemical substances included on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory to report manufacturing, processing and use information to EPA. Although EPA released the rule as final, it still has not been published in the Federal Register
The CDR Rule amends the TSCA Inventory Update Reporting (IUR) Rule and significantly increases the type and amount of information covered entities are required to report to EPA. Entities which will be initially impacted by the new CDR Rule are those that will manufacture chemical substances listed on the TSCA Inventory in volumes of 25,000 lbs. or more at a site within the United States during 2011. Manufactured chemical substances include those imported to a site located within the United States. Entities that may be required to report include: chemical substance manufacturers, chemical substance users and processors who may manufacture a byproduct chemical substance, as well an entity (foreign or domestic) responsible for importing a chemical substance to a site within the United States.
Important changes from the previous IUR include:
Four-year Report Cycle: The CDR returns to the four-year reporting cycle rather than the recent five-year reporting cycle. The CDR Rule requires reports to be submitted to EPA every four years. The first reporting period will be February 1, 2012 to June 30, 2012. The next reporting period is scheduled for June 1 to September 30, 2016.
Electronic Report Submissions: All reports must now be submitted electronically to EPA on e-CDRweb, which is a free reporting tool found on EPA’s Central Data Exchange. For those interested, EPA will conduct a webinar on September 23, 2011, to demonstrate how to submit electronic reports with this tool. EPA has also placed two documents on the docket for the final CDR Rule (EPA-HQ-OPPT-2009-0187), which also provides detailed instructions for reporting chemical information electronically.
Manufacturing Activity Information: For the 2012 reporting year, entities that manufacture or import for commercial purposes 25,000 lbs. or more of a chemical substance on the TSCA inventory at a single site within the United States during 2011 will be required to report:
- The production volume of a chemical substance manufactured at a reporting site during 2011;
- Whether an imported chemical substance is physically at the reporting site during 2011;
- The volume of the chemical substance directly exported and not domestically processed or used during 2011;
- Whether a manufactured chemical substance, such as a byproduct, is being recycled, remanufactured, reprocessed, or reused during 2011; and
- The product volumes for calendar year 2010.
Processing and Use Information: EPA is lowering the threshold of those entities required to report processing and use information. Under the CDR Rule, all entities that manufacture 100,000 lbs. of chemical substances in 2011 are required to report such information, including the number of workers likely to be exposed to the chemical, consumer activities, and commercial activities. The previous reporting threshold was 300,000 lbs.
Confidential Business Information: Any entity claiming that information submitted to EPA is confidential business information (CBI) must now provide upfront substantiation of the CBI claim.
Byproducts Reporting: Under the CDR Rule, byproducts used for commercial purposes are potentially subject to reporting requirements, including component chemical substances that are extracted from a byproduct. EPA has indicated that it intends to provide clarification regarding when byproduct information is required to be reported to EPA.
Enforceable Consent Agreement Substances: Any chemical substance that is the subject of an enforceable consent agreement (ECA) is no longer eligible for a reporting exemption, even if it might otherwise qualify for an exemption based on the nature of the substance. Certain chemical substances that are not the subject of an ECA may still be exempt, including: naturally occurring substances, microorganisms, polymers, certain forms of natural gas, and water. Other chemicals may be partially exempt. For such substances, manufacturers and/or importers must only report identification and manufacturing information to EPA.
Importantly, additional reporting requirements will be phased-in beginning in 2016. For instance, in 2016, an entity will be required to report pursuant to the CDR Rule if the 25,000 lbs. threshold is exceeded during any calendar year since the previous reporting period (for the 2012 reporting period, an entity is only required to report if the 25,000 lbs. threshold is exceeded in 2011).
Likewise, starting in 2016, manufacturers and importers must report the production volume for chemical substances manufactured each year since 2012, rather than only those manufactured during the principal reporting year. Further, the threshold for reporting processing and use information will be further reduced to 25,000 lbs., therefore requiring all entities subject to the CDR Rule to report processing/use information to EPA. Finally, the reporting threshold will be lowered from 25,000 to 2,500 lbs. for any chemical substance subject to: TSCA Section 5(a)(2) Significant New Use Rules; Section 5(b)(4) Chemical of Concern List rules; Section 6 rules related to unreasonable risk findings; and order issued under Section 5(e) or (f); and relief granted in a civil action under Section 5 or 7.