EPA Releases Final TSCA Section 8(a) Reporting and Recordkeeping Rule for Asbestos
On July 6, 2023, the U.S. Environmental Protection Agency (EPA) announced a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) that will require reporting and recordkeeping requirements for asbestos. The pre-publication version of the final rule states that EPA will require certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles, including as an impurity, in the four years prior to the date of publication of the final rule to report electronically certain exposure-related information. EPA notes that this action results in a one-time reporting requirement. EPA “emphasizes that this requirement includes asbestos that is a component of a mixture.” The final rule will require that information be reported on presence, types, and quantities of asbestos (including asbestos that is a component of a mixture) and asbestos-containing articles that were manufactured (including imported) or processed, types of use, and employee data. According to EPA, it and other federal agencies will use the reported information in considering potential future actions, including risk evaluation and risk management activities. The final rule will be effective 30 days after publication in the Federal Register.
EPA states in its press release that under the final rule, manufacturers (including importers) or processors of asbestos between 2019 and 2022 with annual sales above $500,000 in any of those years will be required to report exposure-related information, including quantities of asbestos manufactured or processed, types of use, and employee data. EPA notes that “[i]mportantly, the rule also covers asbestos-containing products (including products that contain asbestos as an impurity) and asbestos that is present as a component of a mixture.” Manufacturers (including importers) and processors subject to the rule will have nine months following the effective date of the final rule to collect and submit all required information to EPA.
The final rule states that the term “asbestos” includes the following types of asbestos:
- Asbestos (Chemical Abstracts Service Registry Number® (CAS RN®) 1332-21-4);
- Chrysotile (CAS RN 12001-29-5);
- Crocidolite (CAS RN 12001-28-4);
- Amosite (CAS RN 12172-73-5);
- Anthophyllite (CAS RN 77536-67-5);
- Tremolite (CAS RN 77536-68-6);
- Actinolite (CAS RN 77536-66-4); and
- Libby amphibole asbestos (CAS RN not applicable (mainly consisting of tremolite (CAS RN 77536-68-6), winchite (CAS RN 12425-92-2), and richterite (CAS RN 17068-76-7)).
According to the final rule, if a specific asbestos type is unknown, a submitter will provide information under the general asbestos form (CAS RN 1332-21-4).
EPA provides the following brief list of the primary data requirements in the final rule:
- Asbestos Domestic Manufacturers (Asbestos Mine and Mill): The provisions in the rule require asbestos domestic manufacturers to provide the quantity manufactured of each asbestos type, activity for each asbestos type (i.e., mining and/or milling), and employee exposure information associated with each activity. EPA states that this includes situations in which asbestos is being mined or milled as an intentional component or as an impurity, such as in vermiculite, talc, and other substances.
- Asbestos Importers: The rule will require importers of asbestos to provide the quantity imported of each asbestos type, activity for each asbestos type, and employee exposure information associated with each activity. This includes importers of mixtures containing asbestos, articles containing asbestos, and impurities (in articles, bulk materials, or mixtures).
- Asbestos Processors: The final rule will require processors of asbestos (including processors of mixtures or articles) to provide the quantity processed per asbestos type, activity for each asbestos type (i.e., primary and/or secondary processing), and employee exposure information associated with each activity. EPA notes that this includes both primary processors and secondary processors of asbestos. This includes situations in which asbestos occurs as an impurity, such as in vermiculite, talc, and other substances.
EPA states that it is taking this action to obtain certain information known to or reasonably ascertainable by manufacturers (including importers) and processors of asbestos that EPA believes will help it better understand the exposures and uses associated with asbestos, including asbestos in articles and as an impurity (in articles, bulk materials, or mixtures, and other substances), that fall under the scope of the rule. EPA and other federal agencies will use the reported information in considering potential actions involving asbestos, including EPA’s TSCA risk evaluation and risk management activities. According to EPA, requiring reporting may also increase public access to this information, “which improves information quality overall, and may help inform and improve compliance assurance and accountability, and drive industry innovation.” EPA notes that the final rule is also subject to a settlement agreement.
Although the reporting rule is superficially similar to the Chemical Data Reporting (CDR) rule, it departs from CDR in several important ways. First, it is a one-time, retrospective rule. It applies to manufacturing, importing, or processing products in the four calendar years 2019-2022, inclusive.
Second, asbestos present as an impurity is not exempt. Manufacturers, importers, and processors will have to ascertain whether asbestos was present at any level in a product. To meet the standard of what is “known or reasonably ascertainable,” it is likely that potential reporters will inquire of suppliers (foreign or domestic) whether asbestos was present and, if so, in what quantity.
Third, asbestos present in articles at any level is not exempt. To meet the standard of what was “known or reasonably ascertainable,” it is likely that potential reporters will inquire of suppliers (foreign or domestic) whether asbestos was present and, if so, in what quantity.
Fourth, the exemption for small businesses is different from both the small business definition for the CDR rule and the small business definition for TSCA fees. For asbestos reporting, companies with annual sales (including the ultimate parent company) below $500,000 are exempt from reporting.
Fifth, processors of asbestos are required to report.
Finally, there are two form types for reporting. “Form A” is available for a reporter that knows or can reasonably ascertain that it manufactures, imports, or processes asbestos but cannot reasonably ascertain or estimate the amount of asbestos. “Form B” is the standard form that also includes the amount of asbestos.
EPA’s Response to Public Comments is not available at the time of this writing. It is not clear if EPA provides any guidance on what due diligence it expects from potential reporters for this type of retrospective reporting. Must all manufacturers, importers, and processors of all products (substances and articles) contact each supplier of each product to see if the supplier was aware of the presence of asbestos in each product? Or may a reporter exercise its judgment about which products are likely to have had asbestos present? The rule discusses articles that are made from asbestos, but it does not provide EPA’s view on articles in which asbestos might have been present as an impurity. We hope that the associated support documents provide additional information and that EPA’s outreach (e.g., webinar and guidance documents) provide sufficient clarity that a potential reporter can understand what is necessary to document that it did its due diligence to look for asbestos in its products.
In our view, EPA consistently underestimates the burden of searching past business records to see if information that was not required to be known might have been known at the time, especially for impurities and articles. That a company “should have known” that information is unpersuasive. If a reader thinks that is a reasonable expectation, we ask that the reader consider whether prior to each purchase the reader made in the last four years, the reader inquired of the supplier whether asbestos was present. Also consider how much effort would be required to evaluate whether there was any way to know now whether asbestos was present in the products purchased in the past. If not, why does the reader think it is a reasonable expectation of a business? A reader who is concerned about asbestos surely would have taken these measures to ensure that each and every product purchased is known not to contain any asbestos at any level, and if the supplier could not supply such an assurance, the reader would have refused to purchase that product.
The Acta Group (Acta®) notes that EPA’s final rule represents a departure from its previous reporting and recordkeeping actions under TSCA Section 8(a). For example, on January 12, 2017, EPA issued a final rule under TSCA Section 8(a) on manufactured or processed nanoscale materials. In that rule, however, EPA established a cutoff of one percent by weight (i.e., 1 wt%) to “define those chemical substances that are not reportable.” We mention this because some nanomaterials have been shown to possess the same hazard concerns (e.g., mesothelioma and lung cancer) as certain types of asbestos. We therefore question why EPA seemingly used a precautionary approach of any quantity of asbestos (e.g., one fiber) rather than a pragmatic cutoff or estimated level that would comply with EPA’s target risk level (e.g., 1E-4 for workers or 1E-6 for consumers/general population). After all, EPA stated that the information reported in the final rule on asbestos will be used for “potential future actions, including risk evaluation and risk management activities.” We note that “chasing” every fiber of asbestos in commerce will not promote efficiency, with EPA identifying unreasonable risks from trace quantities of asbestos. We suspect that EPA will receive thousands of reports of the level of asbestos being “not known or reasonably ascertainable”; all those data will mean that reporters will have spent countless hours filling up EPA’s database with data that will be unusable in EPA’s risk evaluation activities. Public health will be better served if submitter and EPA resources are focused on conditions of use (COU) that present unreasonable risks, along with timely risk management of those COUs.