By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours]. According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear River basin. OIG states that it plans to conduct work in headquarters within the Office of Enforcement and Compliance Assurance and the Office of Chemical Safety and Pollution Prevention, as well as Region 4. The anticipated benefits of the project are to improve controls over TSCA PMN consent orders.
By Lynn L. Bergeson and Carla N. Hutton
On September 3, 2019, Earthjustice filed with the U.S. Environmental Protection Agency (EPA) a notice of intent to sue EPA under Section 20(a)(2) of the Toxic Substances Control Act (TSCA) for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.” According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of new chemical applications under the premanufacture notification (PMN) and test marketing exemption (TME) provisions. Earthjustice states that these violations impede the ability of the listed parties -- the Environmental Defense Fund, Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council, Sierra Club, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial Service Workers International Union, AFL-CIO/CLC -- “to be meaningfully informed of and able to participate in EPA’s review of new chemicals.” Earthjustice asks that EPA immediately cease further violations of TSCA’s disclosure requirements for new chemicals and disclose the information to which the listed parties are legally entitled in the mandated time frames. A detailed analysis and commentary on the notice are available in our September 17, 2019, memorandum, “Earthjustice Notifies EPA of Intent to Sue for Failure to Disclose Information about New Chemical Substances.”
By Lynn L. Bergeson and Carla N. Hutton
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. On August 12, 2019, EPA published a statement of its findings for June 2019. 84 Fed. Reg. 39828. EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5. In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment: EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C).
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website. The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number. Users can also download a spreadsheet with a list of all active cases and each case’s status. More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA. EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing. EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.
EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:
- Verify the asserted CBI claims are correct and consistent; and
- Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.
EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around. Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™. When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such. A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments. B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.
Do not wait until May 30. Begin developing and practicing good CBI practices today.
By Lynn L. Bergeson and Margaret R. Graham
On February 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its notice extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018. 84 Fed. Reg. 2851. The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3). The duration of the extension period is a total of 33 days, but the notice states that because the extension is less than 90 days, EPA reserves the right under TSCA Section 5(c) to issue, for good cause, future additional extensions for individual cases up to a total of 90 days.
More information on why EPA has chosen to do this is in our blog item regarding the pre-publication version of this notice “EPA Extends Review Periods for TSCA Section 5 PMNs, SNUNs, MCANs and Exemption Notices Due to Lack of Authorized Funding and Shutdown.”
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.
Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods. Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018. Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.
EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019). The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).
By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). 83 Fed. Reg. 52179. The proposed rule is significant. Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders. For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule. The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Comments on the proposed SNURs are due November 15, 2018.
Please see the full memorandum for more information on the proposed rule and an illuminating commentary.
By Lynn L. Bergeson and Carla N. Hutton
On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Both direct final rules will be effective on October 26, 2018. Written adverse comments on one or more of the SNURs must be received by September 26, 2018. If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date. In addition to the direct final rules, EPA published proposed rules for both the direct final rules. 83 Fed. Reg. 43606, 83 Fed. Reg. 43607. Comments on the proposed rules are due September 26, 2018.
By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Oscar Hernandez, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) release of its Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for P-16-0510 represents a significant step in EPA’s implementation of the New Chemicals Program under new TSCA. The substance is a polymer (a copolymer of ethylene glycol and propylene glycol end-capped with acrylamide groups). It is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays, and other consumer products.
Notably, EPA’s determination document specifies the conditions of use that are intended, known, and reasonably foreseen. EPA states that there are no known or reasonably foreseen conditions of use other than those intended by the submitter. This may appear to be a controversial statement. Based on EPA’s interpretation of “conditions of use,” it would not pass legal muster to speculate that “anybody could manufacture or use it for anything” and, hence, impose use restrictions to prevent purely speculative applications with no basis in fact or reality. EPA has repeatedly stated that it would base what is reasonably foreseen on information, knowledge, or experience, not on any conceivable condition of use.
EPA identifies the new chemical’s potential health hazard endpoints based on the acrylate/acrylamide category. The concerns are based on acrylamide itself and some low molecular acrylamide analogs and include mutagenicity, developmental toxicity, reproductive effects, neurotoxicity, and a “marginal potential” for oncogenicity. This too may sound alarming. The real question, however, is how toxic is the new chemical and are exposures expected to exceed a “safe” level.
In this case, EPA specifically considers the low-molecular weight (LMW) components of the polymer (i.e., the “worst case”) in its assessment and identifies two analogs of the LMW components. Both analogs have similar structural features (they are end-capped with acrylates), so both are expected to share the same mode of action, and have similar molecular weights as the LMW components of the premanufacture notification (PMN) substance. EPA states that it also considered the toxicity of acrylamide in its assessment. We note, however, that acrylamide is not a good analog because it is substantially lower molecular weight than the LMW components of the PMN substance. Based on the identified analogs, EPA set a no observable adverse effect level (NOAEL) of 250 mg/kg/day for systemic toxicity based on a combined repeat dose/reproductive/developmental toxicity screening test (OECD 422). This study tests for a chemical’s potential to cause toxicity and the primary endpoints of concern relevant to the category (developmental, reproductive, and neurotoxicity). This NOAEL would put the substance in the low-to-moderate toxicity category. Note that despite the nominally alarming set of health endpoints identified in EPA’s category assessment, the 422 study shows the analog is not especially toxic to mammals. By way of contrast, EPA’s most recent Integrated Risk Information System (IRIS) assessment of acrylamide identified a NOAEL of 0.5 mg/kg-day.
EPA also identifies ecotoxicity concerns. Using its predictive models, EPA predicts toxicity levels for both acute and chronic effects to aquatic species and sets concentrations of concern (CoC) at 425 ppb for acute exposures and 43 ppb for chronic exposures. These levels put the substance in the “moderate” category for environmental hazard.
EPA then applies exposure modeling to predict exposures to workers, the general population, and consumers. EPA found that predicted exposures are sufficiently below EPA’s concern level to not present an unreasonable risk to workers, the general population, or consumers. EPA even found that at the “worst case” of 100 percent PMN substance, exposures would still be sufficiently below EPA’s concern level. EPA also evaluated surface water concentrations and found that the estimated maximum acute and chronic concentrations did not exceed the CoCs.
EPA reviewed the PMN, reviewed likely and potential exposures to workers, the general population, consumers, and aquatic species, and did not identify any foreseeable conditions of use that would lead EPA to predict that unreasonable risk was likely.
This is a marked and welcomed departure from previous TSCA Section 5(a)(3)(C) decisions. In nearly all cases in the past, EPA only made a not likely determination if it identified a low hazard for both health and ecological effects (“low/low” cases). Absent a low/low finding, EPA seemingly believed that there could be some conditions of use that could contribute exposures that could exceed EPA’s concern levels. Based on our review, EPA did not explain how it differentiated between “any possible/foreseeable” and “reasonably foreseeable” conditions of use. Instead, if EPA could imagine a set of circumstances that could elicit an exceedance, EPA was of the view that new TSCA precluded it from making a Section 5(a)(3)(C) finding. (While some stakeholders might applaud an approach based on concepts such as the European Union’s Precautionary Principle, this is not how new TSCA, or U.S. environmental legislation more generally, is structured.)
In the case of P-16-0510, EPA more carefully applied new TSCA as written when it identified a low/moderate health concern and a moderate eco concern, and nevertheless took a reasonable approach grounded on the law to go beyond mere consideration of potential hazard and to interpret the “reasonably foreseen” conditions of use and assess unreasonable risk as new TSCA requires. We support this more measured approach and believe it better meets the statutory intent and requirements. As we have written previously, in our view, a “not likely” finding is not limited to cases in which toxicity is so low that exceedances are unimaginable. Rather, EPA must limit its consideration to those conditions of use that are reasonably likely to occur and must evaluate unreasonable risks, not merely hazard, and regulate to protect to the “extent necessary” to protect against such unreasonable risks.
We applaud EPA’s more measured approach that likely indicates a maturation of its understanding of what is needed to meet a not likely determination. We urge EPA to articulate its thinking on what is and is not “reasonably foreseeable” and what PMN submitters can do to help EPA understand not only what is intended, but what might be reasonably foreseen to occur.