On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), also referred to as Toxic Substance Control Act (TSCA) Reform. The Lautenberg Act required the U.S. Environmental Protection Agency (EPA) to amend the TSCA regulation with the overall goal of improving the nation’s management of chemicals manufactured in or imported into the United States. The bill received bipartisan support in both the U.S. House of Representatives and the Senate. Additionally, several chemical manufacturers and industry groups supported the bill in order to improve the consistency of chemical safety regulation nationwide.
TSCA in a Nutshell
TSCA was enacted in 1976, providing EPA with the authority to require reporting, testing, and recordkeeping for chemicals manufactured domestically or imported. TSCA also allows EPA to restrict certain substances that may present a “substantial risk of injury to health or the environment.” TSCA requires facilities that intend to manufacture (or import) “new” chemicals to submit pre-manufacture notifications (PMNs). The majority of compounds undergoing PMN review are approved for manufacturing or importation and the compound (or its trade name if it is confidential) is listed on the TSCA Inventory. Compounds on the public TSCA Inventory can be manufactured or imported without additional approvals from EPA. In cases where EPA determines that a new (or in some cases a previously approved) chemical may pose unreasonable risk to health or environment and should be used only under specific conditions, EPA may issue a Significant New Use Rule (SNUR). Similarly for compounds that have been authorized under a SNUR, if a manufacturer intends to use a chemical in a new way, they may be required to submit a Significant New Use Notice (SNUN). TSCA also requires employers to notify EPA of situations where they have evidence of a new health effect of a compound not previously known through the Substantial Risk Recordkeeping and Notification requirements (section 8(c) and (e)).
Many EHS professionals are familiar with TSCA through the Chemical Data Reporting (CDR) program that requires chemical manufacturers and importers to submit manufacturing information to EPA every four years. The 2016 TSCA CDR report was required to be submitted through EPA’s Central Data Exchange (CDX) website. CDR reporting provides EPA and the public with basic exposure-related information on the types, amounts, and uses of chemical substances manufactured or imported in large quantities in the U.S.
Call for Reform
There has been wide agreement that TSCA was in need of updating. Due to gaps in the regulation, some state governments (California, most notably) have acted independently to further regulate toxic chemicals. These state-specific chemical regulations make it difficult for manufacturers to sell the same formulations from state to state and create an additional burden for notification of health effects on SDSs and other documents. As a result, the chemical industry was supportive of updating the regulations as long as the updates improved consistency nationwide.
Due to the change in administration and a reduction in EPA’s budget, some have questioned whether the TSCA rulemakings would move forward. However, as outlined in a recent BNA article, EPA Administrator Scott Pruitt has indicated that implementing the amended TSCA is a priority and it will continue to move forward.
Key Elements of the Lautenberg Act
The Lautenberg Act required several changes to the TSCA regulation. Some of the more notable new provisions are summarized below.
- EPA must evaluate new and existing chemicals to determine whether they present an unreasonable risk of injury to health or the environment under the conditions of use. Listed below are the first 10 chemicals EPA will evaluate for potential risks to human health and the environment under TSCA reform. (Details on EPA’s recent actions associated with these chemicals are available on EPA’s website.)
- Carbon tetrachloride
- Cyclic aliphatic bromide cluster
- Methylene chloride
- Tetrachloroethylene, also known as perchloroethylene
- Pigment violet 29
- EPA must make an “affirmative finding” for each PMN submittal within 90 days, and this finding must be complete before a chemical can enter commerce. Whereas the previous version of the regulation allowed manufacturers to move forward after the 90-day period, they must now receive EPA approval.
- EPA is required to develop a list of “active” and “inactive” chemicals. The Act indicates that 10 years’ worth of data should be collected in order to develop these lists. On June 22, 2017, EPA released the pre-publication final rule outlining the procedures for facilities to gather and submit this data. The final rule was published in the Federal Register on August 11, 2017.
- EPA must consider potentially exposed or susceptible subpopulations when evaluating chemicals whereas prior PMN health evaluations focused on worker exposures.
- Cost and other non-risk factors are not to be considered when evaluating chemicals.
- Companies may request that EPA evaluate existing chemicals.
- State chemical regulations are preempted under certain conditions. States may not impose new restrictions on a chemical found by EPA not to present an unreasonable risk or that has been regulated by a Section 6 rule.
- The “least burdensome” requirement has been eliminated when evaluating proposed restrictions on chemicals. The prior version of the law required EPA to evaluate every potential way of restricting a chemical and apply the “least burdensome” option. Now, EPA must evaluate the impact of the proposed restrictions on the economy; however, these cost analyses are only to guide EPA when choosing among a limited number of options, each of which must ensure that the chemical is safe for the identified populations. EPA is no longer required to evaluate every conceivable restriction to find the “least burdensome” option.
- Limitations have been imposed regarding confidential business information (CBI). EPA published updates to the CBI rules requiring that up-front substantiation be provided for each CBI claim, effective March 20, 2017. For submissions filed after that date, substantiation must be submitted with the CBI claim. Companies have until September 18, 2017, to submit substantiation for TSCA submissions filed between June 22, 2016, and March 20, 2017. Information will not be treated as confidential and will be made public if substantiation is not provided.
- EPA is authorized to charge higher fees for chemical reviews,but there is no timeline for adoption of higher fees.
Recent TSCA Reform Activity
While certain elements of the reform, such as EPA providing affirmative determination for PMNs, took effect immediately, other elements of the Lautenberg Act set a deadline for future EPA regulations. The Act required that, within one year, EPA must develop rules outlining the procedures by which the agency will 1) determine which chemicals have actively been in commerce over the last 10 years; 2) select chemicals as high or low priority for risk evaluation; and 3) evaluate the risks of high-priority chemicals.
Meeting this timeline, on June 22, 2017, Administrator Pruitt signed the following three final rules:
- TSCA Inventory Notification (Active-Inactive) Requirements (40 CFR Part 710) – Published in the Federal Register on August 11, 2017.
- Chemical Prioritization Process rule (40 CFR Part 702) – Published in the Federal Register on July 20, 2017
- Risk Evaluations for Existing Chemicals under TSCA (40 CFR Part 702) – published in the Federal Register on July 20, 2017
Overview of TSCA Inventory Reset Rule
The TSCA Inventory Notification (Active-Inactive) Requirements Rule was published in the Federal Register on August 11, 2017. Manufacturers have 180 days from this date to submit a list of chemicals manufactured or imported for commercial purposes between June 21, 2006, and June 21, 2016 (the "lookback period"). Therefore, the submission period for manufactures began on August 11, 2017 and ends on February 7, 2018. Each of the properly identified substances will be designated “active”; substances not reported but on the TSCA list will be “inactive.” Reporting requirements apply only to TSCA Inventory-listed substances. Processors may also report to EPA within 420 days after (October 5, 2018) the rule is published in the Federal Register. Although processor reporting is optional, it is encouraged to ensure that all of the processor’s chemicals are listed as “active.” Processor reporting also protects the processor from the inadvertent inactivation of one of their raw materials in the event that one of their suppliers that manufacture or import a chemical did not properly report it.
Companies do not need to report chemicals that are on the “Interim List of Active Substances” as those chemicals were previously reported in the 2012 and 2016 CDR submittals and will already be given active status. Additionally, there are several exemptions listed in the final rule that generally mirror exemptions from PMN rule exemptions (except that reporting will be required for export-only substances). Reporting is not required for pesticides, food, drugs, cosmetics, medical devices, R&D materials, impurities, byproducts that are disposed of (and not used), and some naturally occurring substances. Substances added to the TSCA Inventory on or after June 22, 2016, will be automatically designated as active and need not be reported.
Unlike the CDR rule, which had a minimum reporting threshold of 25,000 lbs (for most chemicals), there is no minimum reporting threshold for the retrospective reporting. Therefore, no matter how small the quantity of chemical manufactured or imported and placed into commerce, it may be subject to reporting.
In addition to the retrospective reporting requirements for the lookback period, the rule provides forward-looking reporting requirements for substances that are identified as inactive after the retrospective reporting has closed. The forward-looking reporting period begins on the effective date of EPA’s active/inactive substance designations. Manufacturers and processors that intend to reintroduce into commerce an inactive chemical for nonexempt purposes must submit a report not more than 90 days before the anticipated manufacture or processing of the chemical.
The rule provides two versions of a Notice of Activity (NOA) reporting form for submitting information required by the rule: NOA Form A will be used for retrospective reporting, and NOA Form B will be used for forward-looking reporting. For retrospective reporting, companies must report chemical identity, type of commercial activity (i.e., manufacture vs. import), and whether the reporter seeks to maintain an existing CBI claim for a confidential chemical identity. For forward-looking reporting, companies must submit the anticipated date by which the inactive substance is to be domestically manufactured, imported, or processed. Similar to CDR, these forms will be submitted via EPA’s Central Data Exchange (CDX) website.
EPA’s Current PMN Statistics
As mentioned, EPA must now provide an affirmative determination on PMNs in progress and submitted after June 22, 2016. When the Lautenberg Act was signed in June 2016, EPA had 334 chemical cases under review for which the 90-day review period began again. As a result, EPA’s backlog of PMNs doubled from the typical level of approximately 300 open cases to more than 600 open cases in January 2017. As of July 5, 2017, the backlog was closer to 400 cases. Administrator Pruitt has commented on this issue, indicating that EPA is making strides to improve the process. EPA has provided a webpage to track its progress on reducing this backlog.
It is clear that EPA intends to move forward on TSCA Reform efforts. Chemical manufacturers and processors should stay up to date with new regulations and guidance documents as they are released. Additionally, the anticipated retrospective reporting may be a significant undertaking and facilities should begin to evaluate how they will gather the necessary data for the 10-year lookback period. Trinity is monitoring TSCA Reform rulemaking and will continue to work with our clients to ensure compliance with these changes. If you have any questions, please contact your local office at (800) 229-6655 or Ellen Hewitt at (614) 433-0733.