TSCA 8 e Substantial Risk Reporting

EPA has directed that a search of records for studies may be limited to records in the location(s) where the required information is typicaUy kept, and to records kept by [those] who [are] responsible for keeping such record or advising the period on the health and environmental effects of chemicals.  

TSCA 8(e) requires reporting to the EPA within thirty calendar days if people who make, import, process, or distribute chemical substances in the United States learn that those chemicals substances may pose a substantial risk of injury to health or the environment. 

TSCA 8(e) is unique and often problematic in practice because the statute is self implementing and does not require that EPA issue regulations effectuating the statutory intent. EPA has interpreted the statute only through 

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Nanomaterials are subject to all of the TSCA regulatory programs. As a result, substantial risks presented by nanomaterials must be reported to the EPA under TSCA 8(e) and allegations of significant adverse reactions must be... 

The R D exemption is only an exemption from the PMN, Inventory, and SNUR requirements of TSCA. R D substances are subject to the substantial risk reporting requirements of TSCA 8(e), any restrictions that may be issued under 4 or 6, import certifications, export notifications, and all other TSCA programs. 

The polymer exemption is an exemption from the premanufacture notice requirements and not an exemption from all of the many programs under the Toxic Substances Control Act. An exempt polymer is subject to all of the other TSCA programs, including (but not limited to) the substantial risk reporting in 8(e) of the statute, Significant New Use Rules, import certifications, and export notifications. 

A recordable allegation, or a pattern of recordable allegations may rise to the level of reasonable support for the conclusion that a substance poses a substantial risk to health or the environment, which must be submitted to the EPA under TSCA 8(e). Therefore, each time an allegation is recorded the prior allegations should be reviewed to determine if a pattern of recordable allegations has been established, and the pattern should be reviewed for 8(e) reportability. 

It is also important to note that it is not uncommon for a chemical substance to have a use that is both within and without TSCA s jurisdiction depending on the markets into which the chemical substance is sold. For example, a chemical substance sold for cosmetic application alone would be outside TSCA jurisdiction and toxicity data generated in relation to the substance would not be subject to potential TSCA 8(e) reporting. If the same chemical substance is also sold for industrial application then it is subject to TSCA and reporting of substantial risk information is mandatory. One must keep in mind as well that markets do not remain static. The toxicity data concerning a chemical substance that was not submitted last month on the basis that the sole application of the substance was as a cosmetic may become immediately reportable this month when the substance is sold into a different application. 

TSCA 8(e) requires the submission of information which reasonably supports the conclusion that [a] substance or mixture presents a substantial risk of injury to health or the environment. The reporting obligation extends to information that does not conclusively demonstrate that a substantial risk exists rather reportable information need merely reasonably support a conclusion of substantial risk. Reporting usually requires judgment calls about whether the information rises to a reportable level. Although the ERA discourages over reporting and file dumps, it is prudent to report in cases of uncertainty because of the consequences that follow from a failure to report. 

The statutory language of TSCA 8(e) relieves a person from the obligation to report substantial risk information if such person has actual knowledge that the Administrator has been adequately informed of such information. It is prudent to interpret that exception quite literally regulated companies should report under TSCA 8(e) unless they have proof that the EPA has received or will receive the same reports. 

The first category includes the following descriptions in the 2003 Reporting Guidance of situations when substantial risk information does not need to be reported under TSCA 8(e) because the EPA has already been adequately informed ... 

Substantial risk information that must be reported to EPA must be submitted immediately, a term that has no statutory definition in TSCA. In its 2003 Reporting Guidance, EPA stated that a person has immediately informed the Administrator if human health information is received by the EPA not later than the thirtieth calendar day after the date the person obtained such information. The EPA has said it is not sufficient for the submittal to be postmarked within thirty days, and it is up to the submitter to ensure that the EPA receives it within the required time frame. Emergency incidents of environmental contamination must be reported to the EPA by telephone as soon as the person has knowledge of the incident. That could be on the order of minutes or hours, but it would be difficult to argue that waiting a full day is contemplated. If the information is required to be, and has been, reported under another statute administered by EPA, such as CERCEA, the TSCA 8(e) report is unnecessary. Any supplementary information must also be reported immediately. 

EPA has indicated that it will not take enforcement actions against individuals related to their exercise of personal responsibility for reporting imder TSCA 8(e) if their employers implement compliance policies and procedures to ensure reporting of substantial risk information. In order to provide that protection to officers and employees, companies must have a policy and procedure for channeling substantial risk information to the person responsible for reporting that information directly to EPA, and a procedure for company processing of substantial risk information. ... 

As discussed in Chapter 7, Reporting and Recordkeeping, 8(e) of the Toxic Substances Control Act (TSCA) requires that any person who imports, manufactures, processes, or distributes chemical substances or mixtures in the United States and who obtains information generated in the United States or in another country that reasonably supports a conclusion that a chemical substance or mixture may present a substantial risk of injury to human health or the environment must immediately report such information to the United States Environmental Protection Agency (EPA), unless the person knows that EPA has already been adequately informed. The information must be submitted to the Agency within thirty calendar days of the individual or business obtaining the information. For information to be reportable under 8(e), it does not need to establish conclusively that a risk exists and does not need to provide evidence that the substance is hazardous to human health or the environment under actual conditions of use and exposure. The information may relate to actual instances of serious human health or environmental injury caused by the chemical or mixture or to observations that are early indications of such effects. Incidents of environmental contamination may also be report-able under TSCA 8(e) and should be reviewed under this procedure in order to determine its immediate reportability as soon as the Company has knowledge of the incident. 

The TSCA Coordinator shall assemble all information needed to evaluate potential substantial risk information for reporting under TSCA 8(e). If reporting is directly addressed in the Reporting Checklists attached to this Procedure the TSCA Coordinator shall determine if reporting is required. 

Greatly simplified, 8(e) of the TSCA statute requires any person who learns that certain chemical substances may pose a substantial risk of inj ury to health or the environment to report that information to the EPA. These checklists were designed to help determine what information needs to be reported. This introduction gives background on 8(e) reporting, discusses the information that does not have to be reported, and discusses some aspects of how to submit reports. It does not cover every topic related to TSCA 8(e), and is only intended as a handy reference. 

EPA sets outs examples of questions that are illustrative of what it might require to support a claim of confidentiality, but they are not intended to be exhaustive and the EPA can certainly require more evidence. For example, for confidential information submitted in a report of substantial risk information under TSCA 8(e) the questions are ... 

Notices of Commencement of manufacture or import are an exception, and the substantiation must be submitted with any notice that claims CBI status for information on the form. 40 C.F.R. 720.102(c)(2). For reports of significant risk information submitted under TSCA 8(e), the EPA guidance does not make substantiation mandatory at the time CBI is submitted because it says that the submitter should substantiate any CBI claims. 68 Fed. Reg. 33129, 33140 (June 3, 2002). 

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