Ethylene Oxide Update: Second Risk Review Process Resolves EPA-OIG Conflict; EPA Advances Sterilizer Agenda (2022)

Thursday, August 11, 2022

The U.S. Environmental Protection Agency’s (EPA) commitment to its controversial Integrated Risk Information System (IRIS) value for Ethylene Oxide (EO) remains unwavering as two recent developments reflect.The first is EPA’s commitment to a process for conducting second risk reviews on air toxics as a way to resolve its longstanding dispute with its Office of the Inspector General (OIG) over the Agency’s regulation of EO.The second is EPA’s identification of the top 23 commercial sterilizers whose EO emissions allegedly contribute to elevated cancer risk in nearby communities, similar to the Agency’s 2018 list of 25 high-priority EO manufacturers and sterilizers.

While that commitment translates into immediate consequences for the sterilizer sector, it has longer-term consequences for industry.EPA’s new second risk review process commits the agency to review other air toxics following the same process it used to develop its IRIS value for EO.Yet, that process lacks any requirement for the Agency to consider input from stakeholders other than those within the Agency itself.Moreover, the process precludes judicial challenge at the time a risk review is undertaken, or the IRIS value is published – stakeholders must wait until EPA has “used” that value in a final agency action.

But an IRIS value itself has influence and substantial consequences well before the appeal of a final agency action becomes ripe.In the interim, EPA can – and with EO certainly has – move forward with a host of agency actions – like proposed rulemakings, public meetings, lists of high-risk facilities, and enforcement initiatives – which significantly impact industry, including by substantially increasing litigation risk.

Moreover, the science about the risks of EO is far from settled and new developments continue to unfold.For example, one fundamental flaw in the current EO IRIS value that is becoming clear is that it is orders of magnitude below naturally occurring ambient background levels in non-industrialized areas throughout the US.Setting a risk standard below naturally occurring levels, is, to say the least, strange; but it demonstrates what happens when real-life data does not corroborate a highly conservative model.1 If EPA views its process for reviewing the EO IRIS value as a “model” for other air toxics, industry should be prepared for similar scientific and legal wrangling for other focus constituents.

Eventually, the IRIS value will be subject to judicial review and EPA will be held to rulemaking standards under the CAA and will perhaps finally be required to defend the reasonability of its standard-setting.Presumably, at that point, EPA’s IRIS value can be finally vetted – but the damage to industry may well have been done, and the fears surrounding EO may be permanently ensconced in the public domain.

What Should I Do?

  • Industrial manufacturers and users of EO should continue to monitor developments related to EO and stay abreast of regulatory, enforcement and litigation trends – these have significant momentum and will remain highly dynamic.

  • Manufacturers of consumer products that contain EO (e.g., detergents, food, spices) should assess their regulatory and litigation risk for those products in the US and keep an eye on global trends (for example, in the European Union, where EO is highly regulated, certain products containing EO have beenrecalled).International trends can influence the domestic agendas in certain states and consumer groups.

  • Industry stakeholders should monitor developments associated with EPA’s work on IRIS values for other priority constituents.EPA is currently assessing IRIS values for17 constituents.This fall, EPA plans to issue revised IRIS values for chloroform, chromium VI, and formaldehyde for public comment.Companies that manufacture or use priority constituents on EPA’s IRIS list should closely monitor developments and utilize the few available public participation opportunities to ensure that the administrative record reflects the full body of scientific literature and data.

EPA’s Second Risk Review Process

Earlier this summer, through aJune 1 EPA memoandJune 7 EPA OIG memo, EPA’s Office of Air and Radiation and its OIG resolved their years-long square-off over EPA’s regulation of air toxics, particularly EO.The last piece of skirmishing centered largely on the process of undertaking second residual risk reviews for sources subject to an existing NESHAP.In a March 31, 2020memorandum, OIG had demanded that EPA formalize specific criteria for determining when to conduct second risk reviews, which EPA had resisted until now.Second risk reviews are not required under the CAA, and some industry observers believe they are unlawful.

In its June 1 memorandum, EPA outlined a compromise process that would involve working closely with the Office of Research and Development (ORD) and the IRIS Program and would include:

  • frequent meetings between EPA Office of Air Quality Planning and Standards’ (OAQPS) Health and Environmental Impacts Division (HEID) management and ORD’s Chemical and Pollutant Assessment Division (CPAD) management;

  • IRIS quarterly Agency-wide updates; issue-specific meetings between OAQPS/HEID and ORD’s Center for Public Health and Environmental Assessment (CPHEA);

  • working meetings related to specific issues, chemicals, or rulemakings; and

  • IRIS nominations by EPA Headquarters and Regional Offices with ORD follow-up meetings.

EPA also stated that a new IRIS value showing increased chemical toxicity would trigger a re-examination of existing NESHAPs.For ongoing NESHAP reviews, it would consider new IRIS data in those reviews. OIG accepted this compromise but encourages the Agency to conduct second risk assessments.

As outlined, the process would require substantial coordination among EPA offices and significant work by EPA.EPA repeatedly points to the example of its review and development of the revised EO IRIS value as the model for how the Agency will address second risk reviews for air toxics in the future.EPA then points to its core guiding principle that it ensures that “we use the most up-to-date toxicity information available for all hazardous air pollutants (HAP) regulated under the Clean Air Act (CAA).”SeeJune 1 EPA Memo.But notably absent from this secondary risk review process is participation by state and industry stakeholders, any entity outside the Agency, or even its own Scientific Advisory Board.

EPA’s repeated reference to its model EO process is as ironic as it is troubling. As a threshold matter, the development and use of the EO IRIS value have been fraught with both procedural and substantive controversy and unresolved litigation.Members of the scientific community, industry, and several states claim the IRIS value is wrong and unsupported by the best science.Critics of the EO IRIS value argue that it excludes the “most up-to-date information,” including the State of Texas Effects Screening Limit (ESL) value. This value has been independently peer-reviewed and references newer studies showing that the EO is farlesscarcinogenic than projected by the IRIS value.

As outlined in ourearlier alertssince releasing the EO IRIS value in 2016, EPA has failed to respond meaningfully to questions about the flaws in its methodology and data selection — even though it has relied upon that IRIS value in rulemaking and other Agency initiatives.Instead, EPA has argued that the Scientific Advisory Board supports the value – another group internal to EPA or dodged the comments altogether.2Due to this regulatory rope-a-dope, the IRIS value has never been subject to judicial review.

Second, notwithstanding its flaws, EPA and others have treated the 2016 EO IRIS value as settled science, with far-reaching repercussions for industry.Relying on the IRIS value’s validity, several states have moved forward with new legislation and high-profile enforcement, including the closure of sterilizers amid a global pandemic.3EPA has held numerouspublic meetingsin which Agency officials have claimed that nearby EO facilities pose unacceptable risks to persons living near such plants; conducted surprise inspections; and issued one of the largest information collection requests in its history to EO manufacturers in an aggressive sprint to review its air toxic rules.Collectively, costs to EO users and manufacturers are already undoubtedly well into the hundreds of millions and increasing – all due to what many allege is a flawed IRIS value that EPA appears unwilling to subject to judicial scrutiny.

List of 23 Sterilizer Manufacturers

Yet EPA shows no sign of slowing down on its campaign to tighten regulation of EO or its reliance on its flawed IRIS value, and most recently, a refocus on the commercial sterilizer category. On August 3, EPAannouncedthat it expects to propose an air pollution regulation for EO emissions from commercial sterilizers later this year.

EPA also published a list of23commercial sterilization facilities that purportedly contribute to an elevated long-term cancer risk for nearby communities. EPA now intends to hold a series of public outreach events, which began with an EPA-hosted August 10 webinar, to raise awareness in communities near commercial sterilizers.Ifpast experienceholds true, industry stakeholders should expect a charged atmosphere in public meetings and little (or no) opportunity to participate.

Importantly, EPA’s emphasis on these 23 facilities is the product of aninformation collection request(ICR) made in 2021 to commercial sterilizers to inform EPA’s risk assessment in areas near approximately 100 commercial sterilizers. Those facilities are now not only the focus of EPA rulemaking, public meetings and enforcement, they are also the target of state enforcement actions and toxic tort litigation.

EPA steadfastly asserts that its sterilizer agenda, likeits second risk reviews, will be based on the “best available science.”Meanwhile, numerous contradictions to its IRIS value remain.

FOOTNOTES

[1] See, e.g.,Ethylene Oxide and Terumo BCT, CO. Dep’t. of Pub. Health and the Env’t. (last visited Jul. 5, 2022);Ethylene Oxide Monitoring Report, GA. Dep’t. of Nat. Res. (May 12, 2022).

[2]In Re: National Emissions Standards For Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review 85 Fed. Reg. 49084, American Chemical Council (Aug. 12, 2020);Comments on EPA Proposed National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review.Docket ID No. EPA-HQ-OAR-2018-0746, 84 Fed. Reg. 69182, American Chemical Council (Dec. 17, 2019).

[3] See, e.g., Illinois SBs1852and1854, GeorgiaHB 3,SBs 426and180, SC, MassachusettsMA H 921.Plaintiffs’ lawyers have brought toxic tort law suits against EO users and manufacturers, citing to the IRIS value in pleadings.See, e.g.,Bureau, et al. v. BASF Corp., et al., No. CIV 21-324-JWD-RLB (M.D. La. 2021),New Mexico, ex rel. Balderas v. Sterigenics U.S., LLC, et al., No. CIV 20-1355-KG-KRS (D.N.M. 2020);Abdelaziz v. B Braun Medical, Inc., No. 191201504 (Pa. Com. Pl. 2020).

FAQs

Is ethylene oxide a carcinogen? ›

The National Institute for Occupational Safety and Health (NIOSH) recommends that ethylene oxide be regarded in the workplace as a potential occupational carcinogen, and that appropriate controls be used to reduce worker exposure.

What is ethylene oxide used for? ›

At room temperature, ethylene oxide is a flammable colorless gas with a sweet odor. It is used primarily to produce other chemicals, including antifreeze. In smaller amounts, ethylene oxide is used as a pesticide and a sterilizing agent.

What is ethylene oxide sterilization? ›

Ethylene Oxide (EtO) is an EPA-registered antimicrobial pesticide used to sterilize medical equipment and spices. It is the only sterilization method available for many medical devices and approximately 50 percent of all sterile medical devices in the United States are treated with EtO annually.

What products contain ethylene oxide? ›

EtO is found in the production of solvents, antifreeze, textiles, detergents, adhesives, polyurethane foam, and pharmaceuticals. Smaller amounts are present in fumigants, sterilants for spices and cosmetics, as well as during hospital sterilization of surgical equipment. How can ethylene oxide harm workers?

What happens if ethylene oxide gets in your nose? ›

EPA has concluded that ethylene oxide is carcinogenic to humans by the inhalation route of exposure. Evidence in humans indicates that exposure to ethylene oxide increases the risk of lymphoid cancer and, for females, breast cancer.

How do you get ethylene oxide out of your body? ›

However, ethylene is easily lost from the body through exhalation, which limits the amount of ethylene oxide produced.

Is ethylene oxide safe to eat? ›

While consumption of foods containing ethylene oxide doesn't pose an acute risk to health, there is an increased risk if contaminated foods are consumed over a long period of time with officials not certain when contamination started.

What are the side effects of ethylene oxide? ›

Acute exposures to EtO gas may result in respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis. Chronic exposure has been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization.

What happens if you consume ethylene oxide? ›

Summary of Nonlethal Effects of Ethylene Oxide in Humans. Signs of toxicity occurring after short-term exposure to ethylene oxide include eye and upper respiratory tract irritation, nausea, vomiting, diarrhea, headache, dizziness, malaise, fatigue, muscle weakness, and signs and symptoms of peripheral neuropathy.

Is it safe to sterilize with ethylene oxide? ›

“…Ethylene oxide is a commonly used method of medical device sterilization. It's considered a safe and effective method that helps ensure the safety of medical devices and helps deliver quality patient care.”

Is ethylene gas harmful to humans? ›

* Ethylene gas can affect you when breathed in. * Skin contact with liquid Ethylene can cause frostbite. * Exposure to Ethylene can cause headache, dizziness, fatigue, lightheadedness, confusion and unconsciousness. * Ethylene is a HIGHLY FLAMMABLE and REACTIVE chemical and a DANGEROUS FIRE and EXPLOSION HAZARD.

Is ethylene oxide sterilization safe for humans? ›

Exposure to ETO can cause eye pain, sore throat, difficulty breathing and blurred vision. Exposure can also cause dizziness, nausea, headache, convulsions, blisters and vomiting and coughing. In a variety of in vitro and animal studies, ETO has been demonstrated to be carcinogenic.

Why is ethylene oxide banned in Europe? ›

However, the fumigation of foods and food storage areas with ethylene oxide has been discontinued in much of the world, including the EU which banned the use of ethylene oxide as a pesticide in 1991, due to its highly toxic nature.

Is ethylene oxide in shampoo? ›

Ethylene oxide is used to make a variety of products found all around your house – from shampoos to disinfectants to laundry detergent. It is also a necessary ingredient for some highly durable fabrics and textiles used in clothing, carpet, upholstery, and pillows.

Is ethylene oxide in noodles? ›

instant noodle variants are safe for consumption. However, ethylene oxide was found in the Lucky Me! Pancit Canton Kalamansi variant at a level below the EU acceptable level of 0.02 mg/kg.

Does ethylene oxide occur naturally? ›

In addition to its industrial uses, ethylene oxide also occurs naturally in our bodies from metabolizing food. We all have some ethylene oxide in our bodies.

Can you be allergic to ethylene oxide? ›

Ethylene oxide (EO) is widely used as a sterilization gas for heat-sensitive devices. In EO-sensitized patients, this type of sterilization can cause rare but major allergic reactions such as hives, rash, asthma, or anaphylactic shock.

What is a safe amount of ethylene oxide? ›

NIOSH: The recommended airborne exposure limit (REL) is less than 0.1 ppm and 5 ppm, not to be exceeded during any 10-minute period per day. ACGIH: The threshold limit value (TLV) is 1 ppm averaged over an 8-hour workshift.

Is ethylene oxide an alcohol? ›

Ethylene oxide is a colorless and flammable gas with a faintly sweet odor. Because it is a strained ring, ethylene oxide easily participates in a number of addition reactions that result in ring-opening. Ethylene oxide is isomeric with acetaldehyde and with vinyl alcohol.
...
Ethylene oxide.
Names
CompTox Dashboard ( EPA )DTXSID0020600
62 more rows

How do you store ethylene oxide? ›

Store in tightly closed containers in a cool, well-ventilated area away from heat, sparks, or sunlight. Sources of ignition such as smoking and open flames are prohibited where ethlyene oxide is handled, used, or stored.

Where is ethylene banned? ›

Use of the chemical ethylene oxide in the food industry is banned in Europe because it is 'carcinogenic, mutagenic and reprotoxic'. It can be found as a contaminant in baked goods, cereals, seeds, ice-creams and yoghurt.

Can ethylene oxide cause headaches? ›

Ethylene oxide (C₂H₄O) is a flammable gas with a slightly sweet odor. People exposed to it may: Have headaches. Feel sick to the stomach.

Is it true Lucky Me has ethylene oxide? ›

(UPDATED) THE Food and Drug Administration (FDA) said that the Lucky Me! brand of instant noodles manufactured and sold in the country are safe for consumption, except for one variant. This comes after trace amounts of ethylene oxide were found in some batches of Lucky Me!

How long does ethylene oxide sterilization last? ›

As the result, it was found that a satisfactory sterilization effect could be obtained under the sterilization conditions of an EO gas concentration of 500 mg/liter, a sterilizing temperature of 55 to 60 degrees C and a sterilizing time of two hours, and under these conditions the concentration of the residual ...

Why is ethylene oxide in ice cream? ›

Ethylene oxide may be used to fumigate agricultural products to prevent microbial contamination. Traces of this pesticide found in fumigated products such as vanilla pods and locust gum, which are used in very small quantities, may carry into the finished ice-cream products.

Does ethylene oxide break down? ›

Ethylene oxide is a gas, so it can be released by leaks in equipment in factories or hospitals. Once in the air, it breaks down over several months. If it is released in water it breaks down in just a few days.

What is ethylene glycol poisoning? ›

Ethylene glycol poisoning can cause dysrhythmias and heart failure. Ethylene glycol toxicity is characterized by an osmolal gap and metabolic acidosis with an elevated anion gap. Nephrotoxicity after ethylene glycol ingestion typically occurs 24-72 hours after acute exposure.

How long do carcinogens stay in the body? ›

Some chemical carcinogens are persistent in the environment because they do not degrade rapidly. In the human body, they are not easily metabolized or excreted. Consequently they accumulate and may have half-lives of a decade or more.

Is ethylene oxide sterilization safe for humans? ›

Exposure to ETO can cause eye pain, sore throat, difficulty breathing and blurred vision. Exposure can also cause dizziness, nausea, headache, convulsions, blisters and vomiting and coughing. In a variety of in vitro and animal studies, ETO has been demonstrated to be carcinogenic.

What is ethylene oxide effects on humans? ›

Acute exposures to EtO gas may result in respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis. Chronic exposure has been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization.

Is ethylene oxide safe in food? ›

The use of ethylene oxide is prohibited in food production as the substance can have mutagenic and carcinogenic effects.

Is ethylene harmful to humans? ›

HAZARD SUMMARY

* Ethylene gas can affect you when breathed in. * Skin contact with liquid Ethylene can cause frostbite. * Exposure to Ethylene can cause headache, dizziness, fatigue, lightheadedness, confusion and unconsciousness.

What happens if you consume ethylene oxide? ›

Summary of Nonlethal Effects of Ethylene Oxide in Humans. Signs of toxicity occurring after short-term exposure to ethylene oxide include eye and upper respiratory tract irritation, nausea, vomiting, diarrhea, headache, dizziness, malaise, fatigue, muscle weakness, and signs and symptoms of peripheral neuropathy.

Is ethylene oxide a cigarette? ›

A chemical used to make antifreeze, to clean medical equipment, and as a pesticide. It is also found in tobacco smoke. Being exposed to ethylene oxide can cause lung damage, headache, nausea, vomiting, diarrhea, and shortness of breath.

Is ethylene oxide in noodles? ›

instant noodle variants are safe for consumption. However, ethylene oxide was found in the Lucky Me! Pancit Canton Kalamansi variant at a level below the EU acceptable level of 0.02 mg/kg.

Does ethylene oxide occur naturally? ›

In addition to its industrial uses, ethylene oxide also occurs naturally in our bodies from metabolizing food. We all have some ethylene oxide in our bodies.

Can you be allergic to ethylene oxide? ›

Ethylene oxide (EO) is widely used as a sterilization gas for heat-sensitive devices. In EO-sensitized patients, this type of sterilization can cause rare but major allergic reactions such as hives, rash, asthma, or anaphylactic shock.

What is a safe amount of ethylene oxide? ›

NIOSH: The recommended airborne exposure limit (REL) is less than 0.1 ppm and 5 ppm, not to be exceeded during any 10-minute period per day. ACGIH: The threshold limit value (TLV) is 1 ppm averaged over an 8-hour workshift.

Is ethylene oxide banned? ›

However, the fumigation of foods and food storage areas with ethylene oxide has been discontinued in much of the world, including the EU which banned the use of ethylene oxide as a pesticide in 1991, due to its highly toxic nature.

Where is ethylene banned? ›

Use of the chemical ethylene oxide in the food industry is banned in Europe because it is 'carcinogenic, mutagenic and reprotoxic'. It can be found as a contaminant in baked goods, cereals, seeds, ice-creams and yoghurt.

Why is ethylene oxide in food? ›

EtO is used for fumigation of low water activity foods, such as nuts, spices, dry fruits, milk powders and cereals, to protect them from microorganisms and insects [6].

Do bananas give off ethylene gas? ›

"Bananas make other fruit ripen because they release a gas called ethene (formerly ethylene)," added Dr Bebber. "This gas causes ripening, or softening of fruit by the breakdown of cell walls, conversion of starches to sugars and the disappearance of acids.

Do apples give off ethylene gas? ›

Apples, bananas, melons, pears and peaches are ethylene producers. Tomatoes are moderate ethylene producers. Broccoli, cabbage, cauliflower, etc., are ethylene sensitive. So, by the rule of the thumb it is preferable to avoid storing ethylene producing fruits with ethylene absorbing ones.

Which fruit has the most ethylene gas? ›

Apples. Apples are probably one of the most common ethylene producers, so keep them far away from your other produce!

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