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By Lynn L. Bergeson and Carla N. Hutton
 
According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
 
OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”
 
To expedite the audit, OIG asks that OSCPP provide the following information:

  • Any training materials, handbooks, or other materials related to the review of new chemicals;
  • Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
  • Scopes of work for any contracts related to the new chemicals review process;
  • Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
  • New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in our October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.


 

By Lynn L. Bergeson

EPA announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives. EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures. EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs. According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.” Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.

EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future. EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.

EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means. According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.

Bergeson & Campbell, P.C. Commentary

The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable. This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5. In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order. EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk. It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain. EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise. The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process. A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.” Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision. If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data. In Bergeson & Campbell, P.C.’s (B&C®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.

EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development. B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting. A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector. The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so. Today’s unexplained reversal is difficult to reconcile with these facts. If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016. As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.


 

By Lynn L. Bergeson

On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include:

  • An overview of EPA’s updated “Working Approach” document that builds on EPA’s “New Chemicals Decision Making Framework: Working Approach to Making Determinations under Section 5 of TSCA”;
     
  • A demonstration of how EPA uses key concepts in the Working Approach to reach certain conclusions and/or make determinations under TSCA Section 5(a)(3) using case examples;
     
  • An update on confidential business information (CBI) process improvements and clarifications; and
     
  • A discussion of EPA’s ongoing efforts and progress to increase transparency.

During the meeting, EPA will provide an opportunity for stakeholders to provide input on the topics mentioned above. Feedback can also be submitted via the docket on or prior to January 24, 2020.

By the end of 2019, EPA expects to make the “Working Approach” document available for written public comments


 

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

 

On May 8, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 25 chemical substances that were the subject of premanufacture notices (PMN).  The SNURs require persons who intend to manufacture (including import) or process any of these 25 chemical substances for an activity that is designated in the SNUR as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.  The rule will be effective July 7, 2015.

                                               

The draft final rule includes SNURs for several biobased chemicals.  The SNURs for fatty acids, satd. and unsatd alkyl-, esters with polyol (generic) (PMN Number P-13-139) and fatty acids reaction products with polyethylenepolyamine and naphthenic acids (generic) (PMN Numbers P-14-616 and P-14-617) limit uses of those substances to those in the PMNs, but that aquatic toxicity testing could demonstrate lower hazard and obviate the need for the SNUR.  A SNUR for 1,2,3-propanetriol, homopolymer, dodecanoate (PMN Number P-14-395), which could be a biobased chemical, limits “use of the substance that results in releases to surface waters exceeding 18 ppb.”  Again, aquatic toxicity testing could demonstrate lower hazard and lead to a higher concentration limit or obviate the need for the SNUR.  These SNURs demonstrate what we have stated many times, namely that biobased chemicals are “renewable,” but not necessarily non-toxic.  Esters are a category that triggers concerns according to EPA’s New Chemicals Program Chemical Categories report, so regulations to limit releases of these substances to water should not be a surprise.  When submitting PMNs to EPA for new biobased chemicals, companies should keep in mind that robust pollution prevention statements can offset possible concerns by putting the new biobased substance in a risk context with incumbent technologies that it may replace.  EPA can make a reduced risk determination and forgo regulation if it has sufficient information to substantiate the relative risk of the new substance and the incumbent it will displace.