EPA holds meeting to discuss delays in new chemicals determinations


Aug. 01, 2022

On July 27, 2022, the Environmental Protection Agency’s (EPA) Office of Pollution Protection and Toxics (OPPT) New Chemicals Division held a meeting to kick off a webinar series to increase transparency, create efficiency, and reduce delays in the determinations of new chemicals submissions under section 5 of the Toxic Substances Control Act (TSCA). The first in a three-meeting series focused on the reasons for delays in concluding new chemicals evaluations. The next two webinars will take place in the fall.

Executive Summary

  • Dr. Michal Freedhoff, EPA’s Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), has been talking about the lack of staff and that resources are stretched thin at the EPA causing delays and missed deadlines. The New Chemicals Division pushed back on the resource theory as the cause for delays (for new chemicals) and put some of the blame on industry backed up by submission data.
  • The meeting was kicked off by Dr. Louis “Gino” Scarano, a Supervisory Toxicologist who was joined by Ariel Hou, P.E., of the Chief Risk Assessment Branch 2 and Ritesh Tiwari P.E., a Team Leader for New Chemicals Risk Assessment. Ms. Hou presented the team’s findings.
  • The EPA discussed how it evaluates data provided in new chemical submissions under TSCA section 5, and the delays that can occur due to the “rework” required when additional information is submitted after EPA has already evaluated the data submitted with the initial application.
  • The main objective of the meeting was to explain what types of data are submitted after initial notification by industry and evaluation by EPA and the subsequent inefficiencies created that result in delays in determinations for new chemicals.

Regulatory context

  • On June 22, 2016, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” was signed into law, amending the 1976 Toxics Substances Control Act ( 15 U.S.C. § 2601 et seq., 2016). TSCA requires EPA to make affirmative determination on whether a new chemical presents an unreasonable risk to human health or the environment under known, intended or reasonably seen conditions of use for every new chemical substance.
  • TSCA Section 5 (amended in December 2019) governs chemicals that are not listed on the TSCA Inventory. Those substances listed on the Inventory are considered “existing chemicals.” Any chemical not listed is considered a “new chemical substance.” Entities planning on manufacturing or importing a new chemical must submit a pre-manufacture notice to EPA before any activity is initiated.
  • A pre-manufacture notice or PMN must be submitted to the EPA at least 90 days prior to manufacturing the chemical. The PMN must include the following information which is considered by risk assessors:
    • Chemical identity
    • Structure and formula
    • Process diagram and description
    • Production volume
    • Byproducts and impurities
    • Intended use
    • Environmental releases
    • Disposal practices
    • Human exposure
    • Existing available test data on the effect on human health and/or the environment
  • Certain categories of low volume chemicals are exempt from full premanufacture notice review under section 5 of TSCA. The low volume exemption (LVE) is for chemicals manufactured at 10,000 kg/year or less. LVEs undergo a 30-day review.
  • Low release low exposure exemptions (LoREX) are those chemicals with low environmental releases and human exposures. The exemption is intended to encourage their development regardless of production volume.
  • Significant new use notification (SNUN) is required for chemicals on the inventory proposed to be used in a significantly new way. These are subject to the TSCA section 5(a) Significant New Use Rule (SNUR) which requires an entity to submit a significant new use notification (SNUN) to EPA at least 90 days before the manufacture, import, or processing of the chemical substance for the new use using the standard e-PMN form.
  • Notices are submitted using EPA’s e-PMN software via the Central Data Exchange (CDX) where submitters can submit the application and supporting documentation.

EPA New Chemicals Division meeting

  • The focus of the meeting was the “rework” of the application process that takes place when applicants provide additional information after the review process has already begun, and the types of information submitted causing the rework.
  • During the new chemical review process, companies sometimes provide additional information to supplement their submission well after EPA has begun a risk assessment. The additional information often relates to environmental release of and/or occupational exposure to the new chemical substance (NCS), or “engineering” information.
  • Additional information results in rework in EPA’s engineering assessment, and other downstream assessments in the risk assessment workflow. EPA is looking for ways to improve efficiency in the new chemical review process. Reducing “rework” is one area for potential efficiency improvement. EPA analyzed 94 cases submitted from 2019 to 2022 that had additional information submitted after the initial notification was submitted.
  • LVE cases made up almost half of those reviewed (45) and three LVE modifications; 40 PMNs, one SNUN, and five LoREX cases.
  • The causes of rework were organized into categories, or “bins.” These bins include changes in production volume and/or batches, number of sites (for manufacture, import, process, or use of NCS), condition of use, environmental release (air, water, soil), worker exposure, and engineering controls (ventilation, process enclosure).
  • The bin with the most rework cases, “material balance parameters,” concerns information on the lifecycle of the NCS, such as changes in the chemical’s intended condition of use or exposure scenario, with most of the new information related to adjusted batches and changes in production volume.
  • The bin with the next highest rework cases, “environmental release parameters,” concerns the type of environmental release (e.g., air, water, incineration, land) and waste disposal method. Half of the new information submitted concerned releases that occurred when the transport container containing the chemical was cleaned, which resulted in releases to air, water, and/or soil. The most common change or addition to information concerned a new or changed container (20%)
  • The environmental release media bin covers changes in information on the disposal of process wastes and releases to the environment. This was the third most frequent change in data. Most commonly, the type of release media changed from a default to a specific release media (63%), with 37% of the changes or additions removed water as the release media.
  • The engineering controls bin, which concerns worker protection technology was the next most common addition or change to information. Engineering controls protect workers by removing hazardous conditions or by placing barriers between the worker and the hazard. Some examples are exhaust ventilation, process enclosures, removal of dust, etc.
  • These four bins accounted for 80% of the rework caused by changes, and/or additional information submitted by companies after the initial new chemical notification was submitted. The remaining 20% of the re-work were for changes to lifecycle/intended conditions of use of the NCS, followed by site information, and worker exposure parameters.
  • The most common update resulting in rework was additions or updates to engineering controls which are worker protection issues. This information should be established at the site and should not change after the submission of a notification.
  • The EPA then went through the process for a sample case that had to be reworked. In the initial submission the submitter declared the site was in operation 250 days per year. However, in the second submission to update information, the days of operation were decreased to 50 days per year. This data change caused a significant rework as most calculations had to be completely redone.
  • The same submission also changed how the residue from equipment cleaning was disposed. The initial submission and first re-submissions declared the release was to water, incineration, or land, which is the default. The second re-submission stated the residue went only to incineration. Removing two out of the three environmental media resulted in a significant change with corresponding rework.
  • For the container discharge, the initial submission declared the release was to water, incineration, or land. The first re-submission entirely removed the default discharge for the container residue and declared there was no container release at all. This major change also caused substantial rework.
  • EPA calculated that an individual case may be reworked anywhere from one to five times and that these reworks could add at least several months to the notice review.

Q&A session

These questions were posed by stakeholders and responded to by EPA.

  • Stakeholder Question (SQ): When determining the number of operational and end-use sites, should consumer, commercial, and industrial sites be included in the submission or just industrial sites? EPA replied that since the engineering assessment focuses on industrial and commercial sites, the estimates should contain both industrial and commercial sites. Since it’s challenging to identify the number of consumer uses, it’s beneficial if it’s included but understood that it’s difficult to estimate.
  • SQ: What prompts these changes to submissions — are the requests coming from the EPA for more information from the submitter, or is additional information provided by the submitter? EPA responded that they are not asking for rework. The example provided of a rework showed how an initial case was first submitted and how it was approached. Then the submitter came back with more information and a second assessment was needed and then a third. The changes are driven by submitters not providing accurate information with the appropriate supporting data and documentation from the start.
  • SQ: Why do companies typically revise the original volumes submitted ? EPA explained the change could be driven by a determination of unreasonable risk and the submitter lowers the production volume, to change the determination.

What’s next?

  • The message from EPA’s New Chemicals division was clear and backed up with relevant data. If the application is initially submitted with complete information, there will be no rework required. This will significantly reduce delays and staff workload.
  • EPA is planning additional webinars this fall to provide transparency on how it evaluates quantitative and qualitative information, with the level of detail required for a successful application.
  • A third webinar is planned to address commonly missing items from Section 5 submissions, as well as EPA’s evaluation of environmental releases on sites that are not controlled by the submitter, and their impact on the engineering assessment. Actual case examples will be provided but redacted to respect Confidential Business Information (CBI).
  • Commenters have complained about the lack of responsiveness by EPA reviewers in the New Chemicals Division. Hopefully these future webinars will offer opportunities to for better communication between the EPA and stakeholders.

To contact the author of this analysis, please email Patricia Iscaro.

Key documents and dates

Get an insider’s view on regulatory movements.

Sign up for AgencyIQ’s newsletters to receive exclusive regulatory updates and analysis impacting the life sciences or chemical industry.

Copy link
Powered by Social Snap