Update (September 21, 2016): EPA recently extended the 2016 submission deadline for Chemical Data Reporting to October 31, 2016 (see Federal Register notice).
This year, environmental managers should be planning and budgeting for preparing their Chemical Data Reporting (CDR) submittals to the EPA, as required under the Federal Toxic Substances Control Act (TSCA). This reporting is now on a four-year cycle, replacing the previous Inventory Update Rule (IUR) requirements. The purpose of the CDR rule is to ensure that EPA is able to maintain a complete inventory of all chemical substances in commerce in the U.S., how those substances are used, and who is exposed to those substances so that it can make better decisions on what substances merit additional study for health or ecosystem risk assessment. For subject facilities, reports must be submitted between June 1 and September 30, 2016.
TSCA was originally enacted by Congress in 1976, and IUR data collection began in 1986. Reports were initially required from subject facilities every five years using EPA’s Form U. The IUR rule has been amended several times since it was promulgated, most recently on August 16, 2011 (76 FR 50816). In addition to changing the name of the report to CDR, the August 2011 amendments made several revisions that primarily expanded the rule’s applicability and the scope of information required to be reported to EPA. The current regulatory text for the CDR can be found at 40 CFR Part 711.
This report can be challenging for facilities to complete due to the infrequency of the reporting cycle. Because reports are required only every four years, much may have changed operationally since the previous submittal (including personnel responsible for completing the report) or have been forgotten. Furthermore, information may be newly required that has never been collected before. For these reasons, preparing for CDR reporting often takes longer than expected, with companies gathering information at the last minute once they realize what is needed. For all of these reasons, it is important to start early to understand applicability and to begin gathering the information needed for the report.
CDR Overview and Updates for 2016
In 2016, CDR reporting is required for any entity that introduced a chemical substance on the TSCA inventory into commerce in the U.S. in 2012–2015 by either manufacturing it (through a chemical change) or importing it from outside the U.S. In most cases, the threshold for triggering the reporting requirement is 25,000 pounds in any calendar year; lower thresholds may apply, however, for certain substances selected by EPA for additional scrutiny. Once reporting is triggered for a given substance, CDR reports must include the following:
- Information on the reporting entity (Part I of the Form U);
- Manufacturing or import volumes and chemical characteristics for 2012, 2013, 2014, and 2015 (Part II of the Form U); and
- Information on industrial, commercial, and consumer uses of the manufactured chemical substances for 2015 (Part III of the Form U).
This year’s reporting could be more complex and in-depth than previous reporting cycles as a result of the August 16, 2011 amendments, which were phased in over the 2012 and 2016 reporting cycles. The 2011 amendments lowered the threshold to trigger reporting of data on the “downstream” users and uses of the substance (Part III of the Form U) from 100,000 pounds per year to 25,000 pounds per year. For 2016, if reporting is triggered for a chemical substance, all three parts of Form U must be completed (unless certain partial exemptions apply), with gathering and compiling information for Part III often taking much more time than needed for Parts I and II. The information required for Part III may not be readily accessible, and companies, in conjunction with their accounting and marketing departments, will need to expend additional effort to gather the required data. It is also possible that outreach to customers may be required in order to collect information on the end use of these products.
Other updates phased in with the 2012 reporting cycle that continue to apply for 2016 reports are listed below.
- Electronic reporting through the Central Data Exchange (CDX) using the e-CDRweb program is required. Paper submittals are no longer accepted.
- The reporting standard for CDR is information that is “known to or reasonably ascertainable by” (KRA), rather than the previous standard of “readily obtainable.” KRA is defined in 40 CFR 704.3 as all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. Companies can report data elements in CDR as “not known or reasonably ascertainable” (NKRA), but should understand the definition of KRA when doing so.
- Requirements for claiming data elements are Confidential Business Information (CBI) have changed. A company may assert a CBI claim only for information that is not publicly available. For each data element claimed as CBI, Form U must be submitted with detailed written answers to specific questions in order to substantiate the claim’s compliance with regulations on public availability of environmental information. Additionally, the answers must be specifically certified by the authorized official.
Successful CDR Reporting
Due to the complexities associated with TSCA CDR applicability determinations, information gathering, and report preparation and submittal, environmental managers may benefit from the following list of suggestions to ensure successful completion of their CDR report.
- Start early, even if you have prepared TSCA CDR reports before. Changes to operations and regulatory requirements could mean that reporting may be required for additional chemical substances, and information not asked for during previous reporting cycles could be required in 2016. Applicability determinations can be made and required data elements can be gathered prior to the beginning of the reporting period.
- Take a systematic approach. First, map out substances to be evaluated for reporting applicability, then evaluate each substance, comparing with exemptions and documenting the thought process on each. Next, gather information for the list of substances to be reported. (Finding the right person to provide the information needed might take more time than expected, and that person will have their own schedule constraints that may conflict with unexpected requests for data to be used in environmental reports.) Finally, prepare and submit the reports.
- Use the correct chemical name and Chemical Abstract Service Registry Number (CAS RN) when determining applicability. The list of chemical substances on the TSCA inventory is extensive—nearly 85,000 chemicals are listed. However, determining whether a substance that is manufactured is on this list can be complicated by the use of synonyms or industry-specific terms for chemical substances. Identification of the TSCA inventory status for chemical substances can be aided through the use of EPA’s Substance Registry Services (SRS) website.1
- Consider byproducts, waste products, and process/reaction intermediates. Reporting applicability for TSCA CDR includes chemical substances that are manufactured for commercial purposes as defined in 40 CFR 711.3. The term “manufacture for commercial purposes” found in 40 CFR 704.3 includes chemical substances used as intermediates at the site at which they are manufactured and also applies to chemical substances produced coincidentally, including by products.
A key consideration for such chemical substances is whether they provide an immediate or eventual commercial advantage for the manufacturer. If a commercial advantage results, chemical substances—including those commonly thought of as wastes—should be considered to be manufactured for the purpose of TSCA CDR.
- Check for exemptions or partial exemptions. TSCA CDR contains a variety of exemptions and partial exemptions from reporting. These include exemptions for small manufacturers, imported chemical substances in article form, chemical substances manufactured in small quantities for research and development, polymers, water, naturally occurring substances, microorganisms, certain forms of natural gas, and several others. Awareness of possible exemptions can allow companies to avoid the time and effort associated with gathering information for chemical substances that could be exempt or partially exempt from reporting requirements. However, the scope and applicability of these exemptions may be more complex than suggested by the summary headline for each and may require some research and review of EPA guidance documents.
- Get help if needed. EPA has many resources available on its TSCA CDR website2, including a TSCA Hotline for posing questions via telephone or email. Additionally, consultants can help answer questions or provide a wider range of experience or a more strategic approach to CDR reporting than can be offered through EPA’s resources, especially later in the reporting season when EPA’s resources tend to be overloaded and the agency is unable to provide timely responses.
TSCA CDR reporting can be an involved and detail-oriented process. With early planning, use of a systematic approach, and thorough documentation, companies can comply with the reporting requirements in 2016 and lay the groundwork for a smoother and more efficient process in 2020 and subsequent years.