NGOs File Suit against EPA for Failing to Disclose Information about New Chemical Substances

On March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). According to the plaintiffs’ complaint, EPA fails to publish full and complete notices of its receipt of new chemical applications in a timely fashion and does not disclose all non-confidential information, including health and safety studies, supporting such applications. The plaintiffs state that action by the court is needed to ensure that the NGOs and their members “have timely access to information and are able to provide input on the potential risks of new chemicals and the need for protections from those risks prior to completion of EPA’s reviews.” The coalition includes the Environmental Defense Fund (EDF), Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council, and Sierra Club.

The plaintiffs argue that TSCA requires that EPA conduct its review of new chemicals transparently, providing the public: (1) access to information about the new chemical, including potential uses, effects, and exposures; and (2) an opportunity to participate in EPA’s decision-making process. The plaintiffs claim that EPA “currently operates the new chemical program as a black box, denying the public information to which they are legally entitled.” The plaintiffs state that EPA routinely fails to publish notice of its receipt of new chemical applications in the Federal Register within five business days. According to the plaintiffs, TSCA mandates that EPA disclose to the public any health and safety studies and all other non-confidential information submitted in support of a new chemical application, but EPA “routinely withholds such information from the public.” TSCA requires chemical manufacturers to meet certain requirements before EPA can invoke TSCA’s confidentiality provisions to prevent public disclosure of information in the application; the plaintiffs maintain that even when the manufacturer fails to meet these requirements, EPA “routinely” withholds this information from the public. According to the plaintiffs, while EPA’s regulations require that EPA publish the applications in an online docket, EPA fails to do so.

The complaint lists the following violations of duty:

Violations of Duty to Publish Timely Notices of Receipt of PMNs

According to the complaint, for each of the premanufacture notices (PMN) listed in Table 1, EPA failed to publish the required notices of receipt in the Federal Register within five business days of receipt of those PMNs, as required. The plaintiffs argue that EPA’s failures to comply with the notice requirements for the listed PMNs: (1) constitute violations of TSCA; (2) “constitute failures of ‘the Administrator to perform any act or duty which is not discretionary’”; and (3) “establish that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by” TSCA Section 5(d)(2).

Violations of Duty to Publish Complete Notices of Receipt of PMNs

The plaintiffs state that for each of the PMNs listed in Table 2, the notice of receipt that EPA published in the Federal Register failed to include a list or description of any test data submitted with the PMN, despite the fact that the PMN included such test data. The plaintiffs argue that the failures by EPA to comply with the notice requirements of TSCA Section 5(d)(2)(C) and 40 C.F.R. Section 720.70(b)(3) for the PMNs contained in Table 2: (1) constitute violations of TSCA or a rule promulgated under Section 5 within the meaning of TSCA Section 20(a)(1); (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Section 5(d)(2)(C) and 40 C.F.R. Section 720.70(b)(3).

Violations of Duty to Publish Notice of Receipt of an Application for a TME

According to the plaintiffs, for each of the applications for test marketing exemptions (TME) listed in Table 3, “EPA did not ‘immediately’ publish the notice of receipt of the application as required” by TSCA Section 5(h)(6). Nor did EPA summarize the information provided in the application as required by 40 C.F.R. Section 720.38(c). EPA also did not inform the public of the receipt of the TME application until after the 45-day period for making a determination on the application had expired, “depriving interested persons of the opportunity to comment on the application” that is required by TSCA Section 5(h)(6). The plaintiffs argue that EPA’s failures to comply with the “immediate[]” notice requirements for the TME listed in Table 3: (1) constitute violations of TSCA or a rule promulgated under Section 5, within the meaning of Section 20(a)(1); (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Section 5(h)(6) and 40 C.F.R. Section 720.38(c).

Violations of Duty to Make PMNs Publicly Available Online at regulations.gov

For each PMN cited in Table 4, the plaintiffs maintain that EPA violated its duty to make complete PMN public files available in an electronic docket at http://www.regulations.gov, as required by TSCA Sections 5(d)(1) and (b)(3), and 40 C.F.R. Sections 700.17(b)(1) and 720.95, which: (1) constitute a violation of TSCA or a rule promulgated under Section 5; (2) constitute a failure of “[EPA] to perform any act or duty under this chapter which is not discretionary”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Section 5(d)(1) and 40 C.F.R. Sections 700.17(b)(1) and 720.95.

Violations of Duty to Make Health and Safety Studies Available for Examination by Interested Persons

According to the plaintiffs, in response to their requests for PMN public files, EPA “routinely” provided public files in which health and safety studies were redacted in a manner that violates TSCA’s requirement to make such studies available for examination by interested persons and violates TSCA’s prohibition on treating such information as confidential. The plaintiffs claim that EPA “has improperly redacted information from hundreds of health and safety studies listed in Table 5, which includes at least 163 such studies which were redacted or withheld in their entirety.” These failures by EPA to comply with TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Sections 720.90 and 720.95: (1) constitute violations of TSCA or a rule promulgated under TSCA Section 5; (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Sections 720.90 and 720.95.

For the PMNs identified in Table 4, the plaintiffs allege that EPA provided public files that failed to include health and safety studies submitted by the manufacturers. According to the plaintiffs, for each such file, EPA failed to comply with TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Sections 720.90 and 720.95, which: (1) constitutes a violation of TSCA or a rule promulgated under TSCA Section 5; (2) “constitutes a failure of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) further establishes EPA’s pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Sections 720.90 and 720.95.

Violations of Duty to Make SDSs Available for Examination by Interested Persons

For the PMNs in Table 6, the plaintiffs state that EPA unlawfully withheld the safety data sheet (SDS), in whole or in part, from the public files made available for examination. The plaintiffs claim that EPA’s failures to disclose the SDS are failures to comply with TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Sections 720.90 and 720.95, which: (1) constitute violations of TSCA or a rule promulgated under Section 5; (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Sections 720.90 and 720.95.

Violations of Duty to Make All Versions of PMN Available for Examination by Interested Persons

According to the plaintiffs, for the PMNs identified in Table 7, EPA provided incomplete public files that contained fewer versions of the PMN and its supporting documentation than appear to have been submitted. Thus, plaintiffs argue, EPA failed to make available for examination all versions of the PMN or supporting documents, as required by TSCA Section 5(d)(1) and 40 C.F.R. Section 720.95. The failures by EPA to comply with TSCA Section 5(d)(1) and 40 C.F.R. Section 720.95 for the PMNs in Table 7: (1) constitute violations of TSCA or a rule promulgated under Section 5; (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to comply with the nondiscretionary duties established by TSCA Section 5(d)(1) and 40 C.F.R. Section 720.95.

Violations of Duty to Make Correspondence Related to PMNs Available for Examination by Interested Persons

The plaintiffs state that on information and belief, for each PMN identified in Table 8, EPA received correspondence supporting the PMN that EPA failed to make available when it provided public files, as required by TSCA Section 5(d)(1) and 40 C.F.R. Section 720.95, which: (1) constitutes a violation of TSCA or a rule promulgated under Section 5; (2) “constitutes a failure of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establishes that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Section 5(d)(1) and 40 C.F.R. Section 720.95.

Violations of Duty to Make Substantiation Documents Available for Examination by Interested Persons

Table 9 identifies those PMNs where EPA provided a public file in which information submitted with a PMN was withheld as confidential but the public file lacked a substantiation document. The plaintiffs allege that EPA withheld information from the public files identified in Table 9 that is not exempt from substantiation under Section 14(c)(2). The plaintiffs claim that the manufacturer failed to submit a substantiation document for some PMNs contained in Table 9, and EPA’s failures to disclose all information in the public files for those PMNs are failures to comply with TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Section 720.95, which: (1) constitute violations of TSCA or a rule promulgated under TSCA Section 5; (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to comply with the nondiscretionary duties established by TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Section 720.95. The plaintiffs state that, on information and belief, the manufacturer submitted a substantiation document for some PMNs contained in Table 9, and EPA’s failures to disclose the substantiation documents for those PMNs are failures to comply with TSCA Sections 5(d)(1) and 14 and 40 C.F.R. Section 720.95, which: (1) constitute violations of TSCA or a rule promulgated under TSCA Section 5; (2) “constitute failures of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establish that EPA has a pattern or practice of violating the requirements of, and failing to comply with the nondiscretionary duties established by TSCA Section 5(d)(1) and 40 C.F.R. Section 720.95.

Violations of Duty to Disclose Information Where the Manufacturer Has Asserted It Is Confidential under TSCA Section 14(c)(2) Exemptions But the Information Facially Does Not Qualify under Any of the Exemptions

For the PMNs identified in Table 10, the plaintiffs state that EPA withheld documents, in whole or in part, based on the manufacturer’s assertion that the information was confidential under one of the six exemptions from substantiation in TSCA Section 14(c)(2), but the exemptions were “clearly inapplicable” to the withheld information. The plaintiffs argue that in withholding as confidential the information identified in Table 10, EPA failed to comply with TSCA Sections 5 and 14, which: (1) constitutes a violation of TSCA within the meaning of TSCA Section 20(a)(1); (2) “constitutes a failure of ‘the Administrator to perform any act or duty under this chapter which is not discretionary’”; and (3) establishes that EPA has a pattern or practice of violating the requirements of, and failing to fulfill the nondiscretionary duties established by TSCA Sections 5 and 14.

Commentary

There is no question that the law requires prompt disclosure of certain information. Many of these deadlines were explicit in TSCA prior to passage of the Lautenberg Act, so TSCA amendments are not the cause of EPA’s inability to meet those deadlines. EPA had been working through its vast collection of health and safety information, reaching out to submitters to request whether past confidential business information (CBI) claims still apply, and releasing declassified information. Even though EPA’s inability to meet these obligations is not new, the plaintiffs did not bring suit or allege that the nine prior Administrations were hiding something.

Lautenberg clearly requires increased transparency by EPA, but it also imposes many other obligations on tight time lines. EPA has been heroic in its efforts to complete all of its required actions timely and well. EPA has, so far, met its deadlines for actions on Existing Chemicals; EPA has been less successful in reviewing new chemicals in a timely manner. In all of its obligations and operations, EPA continues to evolve its procedures and policies and bring additional resources to bear.

We do not question the plaintiffs’ goals — EPA has a legal obligation to meet these deadlines, and EPA should re-commit to meeting them. We do, however, regret the decision to sue and question whether a lawsuit is the best or only way to achieve those goals. We are not aware of or privy to any discussions or negotiations between the plaintiffs and EPA regarding these transparency issues. It is possible that EPA has made commitments and failed to deliver on them, leading the plaintiffs to file suit out of frustration. There is no basis to assert that EPA is intentionally hiding anything. There is every reason to believe that EPA is overwhelmed by the magnitude of the job it faces under Lautenberg, and the current constraints imposed by COVID-19 do not help. A court’s judgment that EPA is not meeting its obligations will not make the resources necessary to meet those obligations magically appear. Dedicating resources to meet a court-ordered deadline on transparency will undoubtedly mean that EPA will lag in other areas.

We value transparency as TSCA stakeholders. It is vital that all stakeholders be able to understand and evaluate EPA’s policies, procedures, findings, and determinations. EPA has made and continues to make significant strides in meeting its transparency obligations, and we regret that EPA’s limited resources and staffing will need to be redirected to respond to the lawsuit.