By Paul Gessing, President of the Rio Grande Foundation, a a 501(c)(3) research and education institute in Albuquerque, New Mexico. This post is reprinted with Mr. Gessing’s permission after originally appearing on the foundation’s blog, Errors of Enchantment, on July 29.
*****
On December 22, 2020, Attorney General Balderas filed suit against product-sterilization company Sterigenics, alleging that ethylene oxide (EtO) emissions from its plant in Santa Teresa were creating a public nuisance and asking the court to enjoin the emissions.
You can read the AG’s complaint here.
Here is one informative report on lawsuit.
According to the federal court docket (Sterigenics had initially removed the case from state to federal court but the federal court refused to accept the removal and sent it back to the state court), private contingent-fee lawyers from the Delaware-based firm Grant & Eisenhofer are working with Balderas on the suit.
Such state AG-contingent fee attorney arrangements have become commonplace. The alliances raise questions as to who is really in charge of litigating on behalf of the public interest, and what really motivates the private plaintiffs’ lawyers.
Grant & Eisenhofer is advancing hundreds of private lawsuits against Sterigenics. Having a state AG action be successful in enjoining EtO emissions would be a boon to the firm’s private litigation efforts.
Sterigenics has operated the Santa Teresa plant since 1989. It sterilizes surgical kits, preoperative skin products, syringes, tubing, and other medical equipment using EtO. 50% of the devices sterilized nationally are sterilized with EtO. An Albuquerque Journal story noted that the state hospital association wrote to New Mexico Governor Grisham explaining the consequences if the state shut down the plant. The story also relates an affidavit from a device company microbiologist noting the suit’s impact on its product and patients.
The suit alleges that Sterigenics is causing a nuisance with “uncontrolled” emissions of EtO that the attorney general claims are increasing cancer risks in the areas around the plant.
Sterigenics argues that the state offers no evidence of actual harm. The complaint leans heavily on a 2016 U.S. EPA risk assessment that the company says “drastically overestimates the risk from EO exposure.” The company’s brief in opposition to the state’s injunction request adds:
The IRIS [Integrated Risk Information System] erroneously states that an EO of concentration as low as .0002 micrograms per cubic meter (the equivalent of 0.1 parts per trillion) poses a one-in-a-million lifetime cancer risk to someone exposed to that concentration continuously (24 hours per day) over 70 years. That miniscule concentration is order of magnitude below the endogenous EO levels produced within the human body. It is also orders of magnitude below the concentrations of EO in everyday ambient air, which the EPA has reported range from 0.185 to 0.397 micrograms per cubic meter of air (103 to 220 parts per trillion), with an average of 0.297 micrograms per cubic meter of air 164 parts per trillion). It is millions of times below the concentrations emitted by a single lawnmower or a single backyard charcoal grill, and is exponentially lower that the exposure level the U.S. Occupational Safety and Health Administration (‘OSHA’) has determined is safe for employees working inside sterilization facilities.
Sterigenics U.S., LLC’s Brief in Opposition to Plaintiff’s Emergency Motion for Temporary Restraining Order and Preliminary Injunction, New Mexico v. Sterigenics et al., at 9-10 (references omitted).
As explained well in an amicus brief filed by AdvaMed, the Chamber of Commerce of the USA, the National Association of Manufacturers, and the New Mexico Chamber of Commerce, companies like Sterigentics that use EtO in their sterilization must comply with detailed regulations issued by FDA, EPA, OSHA, and the state environmental regulatory agency. Those agencies undertake meticulous efforts to craft and issue those regulations and employ issue experts in the process of setting emissions limits.
The “uncontrolled” emissions allegedly occur a number of ways, including the opening and closing of facility doors and when customers visit the plant and carry away their sterilized products. The federal emissions permits (which are issued by the New Mexico Environment Department and with which Sterigenics is in full compliance) do not impose limits on those emissions because the regulators consider that controlling them is entirely impractical. So what the state’s complaint essentially demands that the emissions limit Sterigenics must meet is zero.
A judicial verdict implementing the AG’s zero-emissions approach would directly conflict with federal and state regulations, placing the AG and the court into the role of environmental regulators, a role they are entirely unfit to fulfill. That outcome creates a compliance nightmare for Sterigenics and bodes ominously for any business in New Mexico or businesses looking to locate offices in New Mexico.
On June 29, District Judge Beyer granted the state’s motion for a preliminary injunction, prohibiting “continued uncontrolled emissions of EtO.” It’s unclear as of this moment what has occurred in the meetings between the state and Sterigenics that the court ordered with a goal of creating a “monitoring protocol.”
Bottom line: Attorney General Balderas’ isn’t doing the state, the state’s business community, or New Mexicans any favors by pursuing this regulation-by-litigation effort to usurp control over EtO and its use from federal and state agencies whose authority over EtO emissions are firmly bound in statutes. His lawsuit will stoke fear over miniscule EtO emissions and device sterilization and any victories in the suit could help the suit’s masterminds in the private contingent-fee lawyer’ bar turn EtO into the next asbestos.
Other resources:
https://cei.org/studies/epa-should-revise-its-assessment-of-medical-supply-sterilant/