Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
EPA today proposed a Significant New Use Rule (SNUR) that, once finalized, would mandate that companies notify EPA prior to engaging in any “significant new use” of any of the 14 chemicals EPA has identified collectively as glymes. Among other concerns, EPA has identified their use in various consumer products and their potential to cause reproductive and developmental toxicity. For most of the glymes, the significant new use would be any use in a consumer product beyond those that are already ongoing. For two of these chemicals, the significant new use would be any use.
This proposed SNUR, which was mired at the Office of Management and Budget (OMB) for more than six months, is now out for a 60-day public comment period. A SNUR is essentially the only means available to EPA under the Toxic Substances Control Act (TSCA) by which it can try to limit the use of an existing chemical of concern. It is far from a perfect means of doing so.
Nonetheless, within its limited authority under TSCA, today’s step by EPA brings at least some degree of scrutiny over a quite nasty group of chemicals.
What the heck is a SNUR?
Section 5(a) of TSCA authorizes EPA to designate by rule certain uses of a chemical to be “significant new uses” and require any company to notify EPA at least 90 days prior to producing, importing or processing such a chemical for such a use. Such a Significant New Use Rule affords EPA the opportunity to review the designated use of chemical (in a manner virtually identical to the way it reviews a new chemical), and decide whether more information is needed to assess its risk or conditions should be placed on it. Sounds good, right? Not so fast:
- Even to require notification of a significant new use via a SNUR, EPA must generally go through a notice-and-comment rulemaking – for each and every case.
- A SNUR cannot require notification by any companies who maintain they are complying with the conditions of the SNUR, naturally raising compliance questions.
- A SNUR cannot reach any activities associated with a chemical that are already underway, because by definition they are not a "new use."
- A SNUR does not regulate a chemical's production or use; it only requires notification of EPA and provides an opportunity for an EPA review. Any regulation would require EPA to demonstrate "unreasonable risk" and promulgate a separate rule under TSCA's Section 5(e) (via a consent order) or Section 6 (a task that has proven virtually impossible in practice).
Nonetheless, a SNUR is better than nothing; in its absence, any company can produce and use any chemical on the TSCA Inventory under any conditions it chooses, without having to notify EPA it is doing so.
EPA’s Federal Register notice announcing the proposed SNUR identifies known uses for some of the glymes, as well as unconfirmed uses for which it seeks more information. It cites specific toxicity concerns for the three glymes for which data exist – but notes its concern extends to all 14 chemicals because of their structural similarity to those that have been tested.
The SNUR for the glymes arose from “risk-based prioritizations” done under EPA’s ChAMP program on two glymes – monoglyme and diglyme. These documents relied on hazard data from the High Production Volume (HPV) Chemical Challenge and use and exposure-relevant data from the Inventory Update Reporting (IUR) rule. EPA’s assessments found these chemicals to be of high concern to workers, consumers and children due to potential risks from known uses. They are both high production volume (HPV) chemicals, produced in amounts exceeding one million pounds annually.
As to the scope of the "significant new use" designations for the group of chemicals, EPA notes:
"Of the 14 glymes, 12 have industrial or consumer uses of some kind and two have no current uses. EPA has preliminarily determined that the manufacture, import, or processing of 12 of the glymes for “any use in a consumer product” is a significant new use, although some ongoing uses are excluded from the SNUR. In addition, EPA has primarily determined that the manufacture, import, or processing of the remaining two glymes for “any use” is a significant new use."
Health concerns raised by two glymes that have been tested
The risk-based prioritization of monoglyme (CAS number 110-71-4) summarizes the available information on its production, uses, hazards and exposure potential. Data from animal studies led EPA to conclude: “The potential health hazard is considered high based on the results of repeated-dose studies using a major metabolite, 2-methoxyethanol (CAS No. 109-86-4) (effects on blood, thymus, and adrenal gland), and on reproductive/developmental toxicity found in studies on monoglyme (effects on sperm production, fetal body weight, and fetal skeletal defects).”
Monoglyme is used as a solvent in industrial products and can also be found in lithium batteries and certain industrial coatings. EPA classified the risk to workers as “high concern” because they are more likely to be exposed than the general population due to the many industrial uses. The known uses of monoglyme also establish the possibility of exposure for commercial workers and consumers (including children), for whom EPA also found the risk to be of “high concern.”
As is the case for monoglyme, EPA’s risk-based prioritization for diglyme (CAS number 111-96-6) classified the chemical as “High Priority, Special Concern.” The health risks associated with diglyme include lower sperm counts, toxicity to bone marrow, anemia, and damage to tissues of the immune system. Studies also link diglyme to reproductive toxicity manifested in pregnancy loss, poor fetal growth and survival, and abnormal development. The health effects are severe and run the gamut of toxicity-induced outcomes.
Diglyme is a solvent used in printing inks, automotive care products, paints and coatings, brake fluid and adhesives and sealants. EPA’s designations of potential risks for workers and consumers (including children) from such uses were again “high concern.”