The EPA raises the alert for ethylene oxide emissions in four municipalities that could increase cancer incidences

Although the evidence collected to date does not allow establishing that there is an imminent risk to the health of most people, the Federal Environmental Protection Agency (EPA) alerted the residents and political leaders of four municipalities where medical device sterilization plants operatefacilities that emit a chemical known as ethylene oxide (EtO) that is believed to increase the chance of developing certain types of cancer in cases of continuous and long-term exposure.

The director of the EPA Caribbean Environmental Protection Division, Carmen Guerreropointed out yesterday that studies carried out by the federal agency concluded that, in a population continuously exposed to EtO for 70 years, the incidence of cancer may increase by 100 cases per million people, or the equivalent of one additional case per 10,000 inhabitants.

In Puerto Rico, none of the sterilization plants that generate EtO emissions have operated for so long, but Guerrero pointed out that the role of the EPA is to alert before it is too late.

There are some communities where, due to long-term exposure to this gas, the risk is high. As this risk is too high, the communities have the right to be informedand it is our duty to provide this new information that the EPA has”, he told The new day.

The Deputy Director of the Division, Jose Fontadded that, As a general rule, the EPA aims that no pollutant puts more than one person at risk for every million inhabitants..

At the moment, the sterilization facility that generates the most emissions in Puerto Rico is Steri-Tech, in Salinas, which, in turn, is among those that release the most EtO in the entire United States. This company is followed, according to data compiled by the EPA, Edwards Life Sciencesin Anasco; customized, in Fajardo; Y Medtronic, in Villalba. Steri-Tech, precisely, is the one that has been sterilizing medical equipment with EtO for the longest time, beginning to use the compound in 1986, that is, 36 years ago.

Puerto Rico at the top

Across the United States, the EPA identified 23 sterilization plants that reported emissions at levels that put their communities at risk in the long term, Puerto Rico being the jurisdiction with the largest number of these facilities.

“Although important for sterilizing things, EtO is known to cause cancer. When people inhale EtO over many years, it can increase the risk of blood cancer and, in women, breast cancer.

On its website, the Association for Advanced Medical Technology (AdvaMed), an international organization that brings together manufacturers of medical devices, questions the methods that the EPA has used in the past to measure the health hazards associated with the use of EtO in sterilization of products, arguing that the emissions generate a “risk value” lower than the levels of the compound found in nature.

The president of AdvaMed, Scott Whitaker, expressed, on August 3, after the EPA notice, that it was “vital” that the federal agency express itself in an “absolutely clear, comprehensive and precise” manner about the implications of the use of EtO to avoid “uninformed political pressures”.

Guerrero emphasized, however, that the EPA’s priority is to protect citizen health, and that the studies that, on this occasion, resulted in the recent alert were based on information provided by nearly a hundred sterilization plants in the United States.

“Public policies always follow science. Science is always more advanced,” said Guerrero.

They rule out non-compliance

The manager of Edwards Lifesciences, Manuel Palmastressed that the warning issued by the EPA in relation to the operations of 23 plants in the United States does not imply that the manufacturers have failed to comply with the regulations.

We have completed a new project with a very substantial investment, where basically with the EPA (we have managed to) take to the next level (compliance with) the emission proposals that the EPA would have for the future. The EPA is talking about a new regulation that will come out in the next few years and we, together with them, working very closely, the complete system has already been installed in the plant and tests have recently been carried out,” said Palma.

In the case of Edwards Lifesciences, its operations specialize in the manufacture of catheters, including some designed for use in neonates that, according to Palma, are the only ones that are manufactured worldwide. Although the technology has advanced and there is the possibility of sterilizing medical equipment without resorting to EtO, he pointed out that certain products still require its use.

“There is (the technology) of the ‘electron beam’, there is gamma, which is by radiation, and already 70% of the volume of the product that was sterilized in Añasco could be converted to an ‘electron beam’ technology. Now, there are products that, due to their configuration, their use and the materials involved, cannot be sterilized in any other way than EtO, ”he said.

Palma explained that the first phase of the measures to limit EtO emissions consisted of the conversion to ‘electron beam’ sterilization of products suitable for it, a process that began in 2016. More recently, the focus has been the design of systems that manage to reduce EtO emissions by 99.9% in cases where its use is required.

“That is part of the ‘performance test’ (performance tests) that we did last week. We are completing the results, which we understand we will have in the coming weeks, by then, together with the EPA, we can close the validation protocol and activate the system. We are ‘targeting’ (aiming at) almost zero (emissions)”, she pointed out.

Stricter regulation

Guerrero stressed that the strictest EPA regulation could be ready by the end of 2023, after going through the public participation and comment procedures.although after it is enacted, an implementation period must be granted to the members of the industry, which can be extended “additional years”.

The mayor of Fajardo, Jose Anibal Melendezacknowledged that the communication he received from the EPA regarding Customed’s operations in the municipality took him by surprise, and raised alarms due to the lack of knowledge about the possible past and future consequences of the community’s exposure to EtO.

In his case, Meléndez announced that the Legal Division will subcontract an environmental engineer to independently advise the city council on possible risks, while requesting a meeting with the secretary of the Health Department, Carlos Mellado. The mayor assured that he would not hesitate to take legal action against Customed, if he concluded that his presence represents a risk to the health of Fajardo residents.

“I don’t know how many jobs they generate, I don’t know how much that company represents in terms of municipal patents, but my position is going to be that if it is harmful -as you are already telling me in the letter-, if they don’t have a way to put some filters or improve gas emissions, close and leave,” said Meléndez, who said he was interested in the Department of Health providing an analysis of the prevalence of cancer in the communities near Customed, which was established in Fajardo in 2005.

“By communicating risks, citizens will always be concerned. We don’t control that feeling, but you should know that we have this new information, that (the risk) is long-term, these facilities haven’t been in operation for more than 35 years, so that continuous exposure 24 hours a day, seven days a week , is conservative and has not been given”, said Guerrero, meanwhile, pointing out that the EPA’s approach is not to “close plants”, but to promote the adoption of more efficient and safer technologies.

continue the dialogue

Guerrero, who met on Thursday with the mayor of Salinas, Karilyn Bonillasaid that he hopes to talk in the coming weeks with the other three mayors, and schedule, between the end of August and the beginning of September, community meetings to serve and inform the residents of these plants.

“We ask the EPA to complete a monitoring study in the short term to validate the information that was provided by the facility itself. In the long term, that regulations be amended to adjust compliance levels. Regarding Steri-Tech, (we demand) that it urgently implement the necessary technology and equipment to eliminate contamination,” Bonilla said.

“The EPA analysis indicates that the air near the Steri-Tech, Inc. facilities does not exceed the short-term health reference points, therefore, it does not represent a health risk”, he pointed out, for his part, Andres Vivonigeneral manager of the plant, specifying that the company also seeks to raise its emissions control from 99% to 99.9%.

On the other hand, Luis Javier Hernández, mayor of Villalba, where Medtronic is located, expressed himself somewhat more reserved than his counterpart from Fajardo, but also pointed out that he is “alert” before the notice issued by the EPA at the beginning of the month.

“I cannot be calm, I have to be alert, waiting for these educational talks to take place to guarantee that people are satisfied and informed. Then I could rest easy. Once Medtronic begins to move to other products, then I would be calmer, ”said the mayor, although he acknowledged that there are certain devices for which there is currently no alternative.

According to Hernández, the manufacturer employs almost 2,000 people, including a “high” percent of residents in Villalba, and its operations represent “30% of the economy” of the town.

In writing, Medtronic Communications Director, Erika Winkelsmaintained that they have operated in Villalba for 50 years “consistently complying” with environmental regulations.

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