Substantial risk information

The term substantial risk information refers to that information which reasonably supports a conclusion that the subject chemical or mixture presents a substantial risk of injury to health or the environment however, such information need not and most typically does not establish conclusively that a substantial risk exists. 

While the Agency s concern was to address the potential personal liability of individuals within a company, a company is otherwise well advised to adopt and implement procedures that ensure that substantial risk information is identified and managed appropriately, if for no other reason than to minimize its own potential liability. 

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. 

Substantial risk information may be generated in animal and in vitro as well as human studies. Animal or in vitro studies may provide evidence of potential human health effects. Serious risks observed in any test subject are reportable without regard to the extent of potential exposure. As stated hy the Agency in the 1991 Reporting Guide ... 

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 ... 

For example, there is no reason why a conspiracy charge could not be predicated on a failure to report substantial risk information to the EPA even if the information had been reported to a state agency. See infra W.R. Grace. 

The second category of statements in EPA guidances is inconsistent with the statute itself, and therefore does not survive scrutiny after the MTBE case. These are the statements to the effect that the statutory obligation to report substantial risk information to the EPA is satisfied if the information is ... 

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. 

To be in possession does not require having a written copy of the information. Knowledge of substantial risk information can be acquired through personal conversations, presentations, and telephone calls. 

A similar issue can occur in a corporate acquisition or merger. Toxicity data in the possession of an acquired foreign entity may come within the possession of a U.S. acquirer by virtue of a corporate stock or asset transaction thus triggering an obligation to immediately report substantial risk information concerning a chemical substance or mixture that the U.S. parent or affiliate manufactures, imports, or distributes in commerce. 

The statutory reporting obHgation is satisfied by informing the Administrator of substantial risk information. The information solicited by the EPA s cover sheet is all that must be submitted to initially meet that statutory requirement. Many companies chose to submit the full studies that they have received as part of their initial submittal. If the EPA requests the full studies and backup data, those must be submitted. 

Entities that either do not have a reporting obligation, such as trade associations, and companies that have concluded that their information does not rise to the level of substantial risk information can report studies to the EPA on a for your information basis. Reporting information on an FYI basis does not technically satisfy that entity s reporting obligation. As a result, companies should be careful to report on an FYI basis only when they are... 

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. ... 

EPA has said it will not enforce TSCA 8(e) obligations against individuals if their employers have adopted and implemented a policy and procedure for employee submission and company processing of substantial risk information. 

In some instances, employees may obtain substantial risk information before the substance is subject to TSCA. For example, the substance maybe a pesticide that is exempt from TSCA, or the substance may not be present in the United States. If the substance becomes subject to TSCA because it is used for a non-pesticidal purpose, or because it is imported into the United States, such information becomes reportable. Therefore, all such information shall be provided to a person in one of the designated functions or the TSCA Coordinator within one business day whether or not the person who obtained that information believes that the substance is subject to TSCA. Upon doing so, the employee fully discharges his or her reporting obligation under 8(e) under ERA policy. 

All people in the designated functions listed above who receive potential substantial risk information or allegations of adverse effects shall immediately inform the TSCA Coordinator. 

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. 

The 8(e) Committee shall meet by the twenty-fifth day after substantial risk information has been obtained. The 8(e) Committee meets in person or remotely to evaluate possible substantial risk information and decides by consensus whether the information should be reported to EPA under 8(e). However, if all members of the 8(e) Committee agree based on information circulated to them prior to a scheduled meeting that the iifformation clearly warrants 8(e) reporting, the 8(e) Committee does not have an obhgation to meet and the TSCA Coordinator shall proceed with Step 5. Large companies may establish a regular schedule of meetings every three weeks.)... 

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