Date: October 22, 2024
To: Michael S. Regan, Administrator
U.S. Environmental Protection Agency 1200 Pennsylvania Avenue NW Washington, DC 20460
Subject: Comments regarding Proposed High-Priority Substance Designation for Vinyl Chloride under the Toxic Substances Control Act (TSCA);
Submitted via Regulations.gov to Docket ID No. EPA-HQ-OPPT-2023-0601-0145
Dear Administrator Regan,
We are writing to voice our robust support for the EPA TSCA high-priority designation of vinyl chloride, and to share several concerns with the prioritization document that was released on 24 July 2024.1 EPA’s proposed overview of the agency’s approach to the forthcoming risk
evaluation suggests impermissible gaps in the assessment as well as methodologies that are not consistent with the best available science.
1. We urge EPA to use measured data rather than rely on industry-submitted data from the Toxics Release Inventory (TRI) to quantify exposure to vinyl chloride for fenceline Much TRI data is based on industry estimates using models, mass balance calculations, or published emission factors. Measured data is far more accurate and revealing, such as the fenceline air monitoring recently conducted by EPA near the Westlake Vinyls facility in Calvert City, KY, where EPA’s air monitoring found dangerous levels of ethylene dichloride (from PVC manufacturing) and other chemicals,2 and the fenceline monitoring that will be required by the new hazardous organic chemical manufacturing rule. We urge EPA to review all sources of measured data including data developed by the fenceline communities themselves.
2. The use of Best Available Science requires that EPA assess cumulative risk—the risk from exposure to multiple chemicals or stressors that are associated with the same health It must also evaluate aggregate risk—the risk from exposure to a single chemical from multiple sources and routes. Many people are exposed to vinyl chloride at work, at daycare, at school, and at home. Fenceline communities and workers are exposed to vinyl chloride via multiple pathways, and to many chemicals simultaneously. Vinyl chloride production facilities release ethylene dichloride as well as plasticizers, PFAS chemicals, chlorine-based compounds, heavy metals, asbestos, dioxins, and many other toxic chemicals. Stressors such as poverty and systemic racism compound the risk. It makes no sense to examine the risk from vinyl chloride as if it is the only source of harm. Vinyl chloride monomer is like the enabler in a very toxic relationship, and to ignore the injury from combined chemical exposures is to undervalue the massive health and environmental assault faced by communities.
3. EPA must consider “unplanned” incidents. Chemical leaks, explosions, and fires are absolutely foreseeable, as are train derailments, vehicular crashes, and other transportation incidents. What we don’t know is the where and the when, but we know they will happen. Between 2010 and 2023, there were 966 incidents where vinyl chloride was released unintentionally: at manufacturing, processing, and storage facilities; on roads and railways; on ships and in port; and at waste The incidents happened with such regularity that they averaged out to one incident every 5.3 days.3 These incidents are “reasonably foreseen.” It would be a legal error not to include them in the risk evaluation.
4. Distribution in commerce—including transportation, warehousing, and every part of the supply chain—must be considered as a source of potential We are surprised that the draft high-priority designation fails to identify distribution in commerce as a source of exposure, especially given the Norfolk Southern train derailment and vinyl chloride disaster that occurred in February 2023 in East Palestine, Ohio. Since 1968, there have been at least 29 incidents in which vinyl chloride-carrying tank cars derailed—a rate of one derailment every other year. A January 2024 report by Toxic-Free Future and Material Research L3C on their investigation into OxyVinyls’ rail route from Texas to New Jersey found that more than 3 million residents live within a mile of the tracks and about 670,000 children attend more than 1,500 schools within the same area.4 EPA must consider the very real possibility of an intentional/terrorist or unintentional transportation incident in a populated area.
5. EPA needs to consider residual vinyl chloride monomer in PVC drinking water When vinyl chloride monomer is polymerized into PVC plastic or vinyl, small amounts of the chemical may remain unpolymerized, as a residual chemical in the PVC that is not molecularly bound to it. This unbound vinyl chloride can leach out. Given that towns and cities across the country – funded by President Biden’s Bipartisan Infrastructure Law5—will soon begin to remove lead service lines and replace them with PVC pipes, there is an immediate need for EPA to evaluate how much residual vinyl chloride monomer is present in the drinking water that passes through PVC service lines, pipes or plumbing fixtures.
6. As noted above, polymerization is an incomplete process and results in unreacted or "residual" vinyl chloride monomer in PVC materials. It is critically important to assess residual vinyl chloride monomer in food packaging and other consumer products. EPA should take the steps necessary to evaluate how much residual vinyl chloride monomer is present in consumer products including children’s toys and costumes, apparel, furniture, kitchenware, building materials, and other products.
7. TSCA requires EPA to evaluate the risk to exposed and vulnerable sectors. Unlike other statutes, TSCA includes an explicit charge to consider Potentially Exposed or Susceptible Subpopulations (PESS). EPA needs to identify all PESS. If the agency fails to fully assess the conditions of use and the exposure pathways that affect vulnerable groups, the evaluation may dramatically underestimate the risk to these susceptible The draft prioritization includes an initial listing of vulnerable sectors, but we seek assurance that others will be included as well.
One such heavily-exposed group are firefighters and other first responders, who face dangerously high levels of dioxins and other chemicals from burning vinyl materials in structural fires as well as in the all-too-common chemical disasters at facilities. This exposed and susceptible sector includes other emergency workers as well, such as those who handled the derailment and the detonation—and who worked to clean the waterways—in the 2023 Norfolk Southern disaster. Their courage and selflessness are commendable. They should not have to pay for it with their lives.
Another such heavily exposed and vulnerable group of particular concern to Moms Clean Air Force are the fetuses and infants along the entire vinyl chloride supply chain—including those at the fenceline of vinyl chloride production, those who suck on PVC toys, and those who reside near landfills, pyrolysis incinerators, and municipal waste combustors.
EPA needs to account for the early life susceptibility of the unborn and the newly born. PVC and other microplastic polymers have been found in the placenta, the amniotic fluid, and human breastmilk. For example, a 2023 study evaluated microplastics in 17 placentas using laser direct infrared (LD-IR) spectroscopy. The researchers detected microplastics in all placenta samples.
PVC was the most common plastic polymer found in the placentas, of the 11 polymer types identified. Specifically, 43.27 percent of the microplastics in the placentas were PVC plastic.6
We emphasize that even though TSCA excludes several categories from regulation (including food, drugs, cosmetics, tobacco, and pesticides) because they fall under the jurisdiction of other statutes, nonetheless those exposures are part of the aggregate risk that EPA must consider in its TSCA evaluation. In the case of infants, even though FDA regulates medical device products, EPA’s TSCA risk assessments will need to consider the elevated exposures to newborns in health care settings. That is part of the aggregate risk faced by infants.
Many newborns are exposed to vinyl chloride, phthalates, and other plastics chemicals in the neonatal intensive care units. Vinyl chloride-based PVC products are extremely common in the form of fluid bags, disposable gloves, feeding tubes, respiratory support tubes, intravenous lines, nasal cannulas, catheters, incubators, and other devices, in addition to the PVC flooring and furnishings. The U.S. healthcare sector procures extraordinary (and increasing) amounts of unnecessary single-use plastics,7 from throwaway plastic surgical tools to disposable blood pressure cuffs, and many of these items are made from PVC.8 EPA must include these exposures in assessing the totality of fetal and infant exposures—they are part of the aggregate risk.
Thus it is critical that EPA treat fetuses and infants as a Potentially Exposed or Susceptible Subpopulation. The EPA prioritization document lists children as PESS but it does not specifically single out infants or fetuses as a category, despite their unique vulnerability.
Protecting fetuses, infants and children is critical, whether they are exposed to vinyl chloride at the fenceline, in proximity to a vinyl chloride disaster site, or in a neonatal intensive care unit.
In EPA’s own words,
“Several studies in experimental animal models have demonstrated that early life exposure to vinyl chloride can increase susceptibility to cancer later in life. Based on these data, the U.S. ATSDR has characterized fetuses, infants, and young children as a “highly susceptible population” for vinyl chloride exposure.
Children are at risk for exposure to vinyl chloride from ambient air contaminated with vinyl chloride by emissions released from polyvinyl chloride (PVC) plastics production and manufacturing facilities, as well as some incinerators. Contamination of
groundwater and drinking water with vinyl chloride-contaminated run-off from such manufacturing facilities is also a concern for exposure of children….
The greatest difference between concentrations of vinyl chloride or vinyl chloride metabolites in maternal blood and in offspring blood was estimated to occur in late pregnancy and the neonatal period.”9
EPA must prioritize early life susceptibility and the impacts of vinyl chloride on fetuses, infants, and children.
8. Vinyl chloride is extremely harmful at every step of the supply chain. This includes disposal. There is no safe and effective way to dispose of vinyl chloride-containing products. PVC is not a “circular” product by any stretch of the imagination. Since TSCA review is required to encompass risks across the full life cycle and from all intended, known, or reasonably foreseen conditions of use of a chemical, it is critical to ask, how does EPA anticipate that the US will safely get rid of all the vinyl chloride it is producing?
EPA’s Chemical Data Reporting tool states that companies reported producing between 10 and 20 billion pounds of vinyl chloride in 2019.10 [Note the 10 billion pounds of uncertainty in this 2019 estimate, which is the most recent data available to the public. Vinyl chloride manufacturers withhold their production volumes as “Confidential Business Information.”] Even if talking about the lesser amount, 10 billion pounds, this is still a very significant amount of vinyl chloride.
Amended TSCA requires EPA to eliminate the unreasonable risk posed by a chemical substance from:
the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of such activities §2605 (d)(3)(A)(i)(I). [Emphasis added.]
We urge EPA TSCA officials to address the particular conundrum of producing such vast amounts of an extraordinarily harmful substance for which there is no safe and effective method of disposal.
* * * *
Moms Clean Air Force commends EPA for proposing the high-priority designation for vinyl chloride. We believe that a thorough and vigorous review of this exceedingly toxic substance will find that the only solution is to eliminate the production and use of vinyl chloride.
Yours sincerely,
Cynthia Palmer
Senior Analyst, Petrochemicals Moms Clean Air Force
and
Dominique Browning
Director and Co-founder, Moms Clean Air Force Vice President, Environmental Defense Fund
1 US Environmental Protection Agency, “Proposed High-Priority Substance Designations under the Toxic Substances Control Act (TSCA); Notice of Availability.” Regulations.gov. (2024, July 25). https://www.regulations.gov/document/EPA-HQ-OPPT-2023-0601-0145
2 US EPA Region 4. Calvert City, Kentucky Volatile Organic Compound (VOC) Air Quality Risk Assessment (2024, January 22) https://www.epa.gov/system/files/documents/2024-01/calvert-city-kentucky-voc-air-quality-risk- assessment_0.pdf
3 Craigie, A. (2024, March 26). New report: Vinyl chloride accidents have happened once every five days since 2010 Beyond Plastics, Earthjustice, Material Research LC3. https://www.beyondplastics.org/press-releases/new-report- on-vinyl-chloride-accidents
4 Toxic-Free Future and Material Research LC3. (2024, January). Maps: the toxic vinyl chloride train route from Texas to New Jersey. https://toxicfreefuture.org/research/toxic-cargo/the-toxic-vinyl-chloride-train-route-from-texas-to- new-jersey/
5 The White House (2024, October 9). FACT SHEET: Biden-Harris administration issues final rule to replace lead pipes within a decade, announces new funding to deliver clean drinking water.
https://www.whitehouse.gov/briefing-room/statements-releases/2024/10/08/fact-sheet-biden-harris-
administration-issues-final-rule-to-replace-lead-pipes-within-a-decade-announces-new-funding-to-deliver-clean- drinking-water/
6 Zhu, L., et al. (2023, January 15). Identification of microplastics in human placenta using laser direct infrared spectroscopy. Science of The Total Environment.
https://www.sciencedirect.com/science/article/abs/pii/S0048969722061599
7 Jain, N., & LaBeaud, D. (2022). How should US health care lead global change in plastic waste disposal? AMA Journal of Ethics, 24(10), E986-993. https://doi.org/10.1001/amajethics.2022.986
8 Plastics and health- An urgent environmental, climate and health issue. (2022, November 30). Health Care Without Harm. https://noharm-global.org/plastics_and_health
9 Vinyl chloride (VC). Environmental Protection Agency. (2007). https://archive.epa.gov/region5/teach/web/pdf/vc_summary.pdf
10 Access Chemical data Reporting data | US EPA. (2024, January 4). US EPA. https://www.epa.gov/chemical-data- reporting/access-chemical-data-reporting-data#2020