On December 1, 2023, the EPA issued orders to Inhance Technologies LLC (Inhance) directing it not to produce per- and polyfluoroalkyl substances (PFAS), chemicals that are created in the production of its fluorinated high-density polyethylene (HDPE) plastic containers.
“This action, taken under the authority of the Toxic Substances Control Act (TSCA), will help protect the public from exposure to dangerous PFAS chemicals in containers used for a variety of household consumer, pesticide, fuel, automotive and other industrial products,” states an EPA news release.
“PFAS should not be in the plastic containers people use every day, period,” said Michal Freedhoff, assistant administrator for the Office of Chemical Safety and Pollution Prevention, in the release. “EPA’s action today is one more way we are furthering the Biden-Harris Administration’s Strategic Roadmap to combat PFAS pollution.”
PFAS are a group of manufactured chemicals that include chemicals known as perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and GenX. There are nearly 5,000 different types of PFAS, some of which have been more widely used and studied than others, according to the U.S. Food and Drug Administration (FDA). PFAS are often referred to as “forever chemicals” because of their persistent nature in both the human body and the environment. They also build up in our bodies over time.
“People may be exposed to these PFAS through their drinking water, fish they eat from PFAS-contaminated waters, and through groundwater that has been contaminated by PFAS,” the EPA news release continues. “Centers for Disease Control and other data show that nearly 100% of people tested have at least one of seven of the types of PFAS that Inhance manufactures in their blood already. Even without further exposure, it would take more than a decade for PFOA from a single exposure, one of the types of PFAS manufactured by Inhance, to leave people’s bodies.”
In 2019, the drinking water used by the town of Easton, Massachusetts, tested positive for PFOA, which was traced back to a mosquitocide used by state officials. In September 2020, the EPA was made aware of this PFAS contamination in the mosquitocide. EPA scientists then determined that the PFAS found in the mosquitocide came from the fluorinated HDPE plastic container used to store the product, which was manufactured by Inhance. The EPA determined that when Inhance fluorinates containers, it manufactures many types of PFAS, including PFOA. The EPA announced in March 2021 that these PFAS can migrate into liquid products like pesticides and can continue migrating over time.
“In March 2022, EPA issued a Notice of Violation to Inhance for its failure to notify the Agency before it began manufacturing PFAS,” adds the Agency news release. “Inhance had five years from the proposal of EPA’s long-chain PFAS significant new use rule in 2015 to when it was finalized in 2020 to inform EPA that it was manufacturing long-chain PFAS as part of its process.
“Following this notice, EPA’s Office of Enforcement and Compliance Assurance (OECA) engaged with Inhance to determine if Inhance had ceased manufacture of the regulated PFAS. Upon determining that Inhance was still manufacturing the regulated PFAS and intended to continue to engage in its fluorination process, OECA referred enforcement to the Department of Justice (DOJ) and DOJ filed suit on behalf of EPA against Inhance in December 2022. Only after these actions did Inhance submit significant new use notices (SNUNs) for the nine PFAS it manufactures to EPA for review on Dec. 30, 2022.”
Upon review of the SNUNs and consistent with the Framework for Addressing New PFAS and New Uses of PFAS, the EPA determined that three of the PFAS (PFOA, perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)) are highly toxic and present unreasonable risks that can’t be prevented other than through prohibition of manufacture.
“Therefore, under TSCA section 5(f), EPA is prohibiting the continued manufacture of PFOA, PFNA and PFDA that are produced from the fluorination of HDPE,” the release continues. “The EPA also determined that the remaining six of the nine PFAS chemicals manufactured by Inhance may present an unreasonable risk of injury to health or the environment and, under TSCA section 5(e), is requiring the company to cease manufacture of these chemicals, and to perform additional testing if it intends to restart production. However, Inhance’s current fluorination process for plastics produces all nine of the PFAS chemicals subject to these orders simultaneously, including PFOA, PFNA, and PFDA. Thus, the production of the other six PFAS could not restart so long as the fluorination process continues to produce PFOA, PFNA and PFDA. These orders become effective February 28, 2024.”
Alternatives to this fluorination process exist that will allow for many sectors to continue to provide products with the necessary protective packaging. Inhance has stated it’s working on changes to its process, with a stated goal of eliminating all PFAS production, according to the EPA.
“As always, EPA will review options for ensuring compliance with the orders, consistent with its enforcement policies, either through further litigation or an appropriate settlement,” according to the Agency release. “EPA also notes that TSCA provides waivers for national defense purposes.”
Mnamo Desemba 1, 2021, EPA ilitoa amri kwa Inhance Technologies LLC (Inhance) kuamuru kwamba haizalishi vitu vya per- na polyfluoroalkyl (PFAS), kemikali zinazotengenezwa katika utengenezaji wa vyombo vyake vya plastiki vya polyethylene ya wiani wa juu (HDPE). "Hatua hii, iliyochukuliwa chini ya mamlaka ya Sheria ya Udhibiti wa Vitu vya sumu (TSCA), itasaidia kulinda umma kutoka kwa mfiduo wa kemikali hatari za PFAS katika vyombo vinavyotumiwa kwa watumiaji wa kaya, dawa za wadudu, mafuta, magari na bidhaa nyingine za viwanda. """ "PFAS haipaswi kuwa katika vyombo vya plastiki watu hutumia kila siku, kipindi", alisema Michal Freedhoff, msaidizi wa msimamizi wa Ofisi ya Usalama wa Kemikali na Kuzuia Uchafuzi, katika kutolewa. "Kama ilivyoelezwa katika taarifa ya EPA, ""PFA ni kundi la kemikali zinazotengenezwa ambazo ni pamoja na kemikali zinazojulikana kama perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA) na GenX.""" Kuna karibu aina 5,000 tofauti za PFAS, baadhi ya ambayo yametumika sana na kuchunguzwa kuliko nyingine, kulingana na Utawala wa Chakula na Dawa wa Marekani (FDA). PFAS mara nyingi huitwa "kemikali za milele" kwa sababu ya asili yao ya kudumu katika mwili wa binadamu na mazingira. Pia hujikusanya katika miili yetu kwa muda. "Watu wanaweza kuambukizwa PFAS kupitia maji yao ya kunywa, samaki wanaokula kutoka maji yaliyochafuliwa na PFAS, na kupitia maji ya chini ya ardhi ambayo yamechafuliwa na PFAS,"" ilisema taarifa ya EPA." "Centers for Disease Control na takwimu nyingine zinaonyesha kwamba karibu asilimia 100 ya watu waliochunguzwa tayari wana angalau moja ya aina saba za PFAS ambazo Inhance hutengeneza katika damu yao. """ Hata bila kuambukizwa zaidi, itachukua zaidi ya miaka kumi kwa PFOA kutoka kwa mfiduo mmoja, moja ya aina za PFAS zinazotengenezwa na Inhance, kuondoka kwenye miili ya watu. <unk> Mnamo 2019, maji ya kunywa yaliyotumiwa na mji wa Easton, Massachusetts, yalijaribiwa kuwa na PFOA, ambayo ilitokana na dawa ya kuua mbu iliyotumiwa na maafisa wa serikali. Mnamo Septemba 2020, EPA ilifahamishwa juu ya uchafuzi huu wa PFAS katika dawa ya kuua mbu. Wanasayansi wa EPA waliamua kuwa PFAS iliyopatikana katika dawa hiyo ya kuua mbu ilitoka kwenye chombo cha plastiki cha HDPE kilichotumiwa kuhifadhi bidhaa hiyo, ambayo ilitengenezwa na Inhance. EPA iligundua kuwa wakati Inhance inatoa fluorine kwenye vyombo, inazalisha aina nyingi za PFAS, pamoja na PFOA. EPA ilitangaza mnamo Machi 2021 kwamba PFAS hizi zinaweza kuhamia katika bidhaa za kioevu kama dawa za wadudu na zinaweza kuendelea kuhamia kwa muda. "Mwezi Machi 2022, EPA ilitoa taarifa ya ukiukaji kwa Inhance kwa kushindwa kwake kuarifu Shirika kabla ya kuanza kutengeneza PFAS, ""aongeza taarifa ya habari ya Shirika." "Inhance ilikuwa na miaka mitano kutoka pendekezo la EPA la ""katika 2015"" sheria mpya ya matumizi ya PFAS ya mnyororo mrefu hadi wakati ilikamilishwa mnamo 2020 ili kuarifu EPA kwamba ilikuwa ikitengeneza PFAS ya mnyororo mrefu kama sehemu ya mchakato wake." Baada ya taarifa hii, Ofisi ya Utekelezaji na Uhakikisho wa Utii ya EPA (OECA) ilishirikiana na Inhance ili kuamua ikiwa Inhance ilikuwa imeacha utengenezaji wa PFAS iliyodhibitiwa. Baada ya kuamua kwamba Inhance bado ilitengeneza PFAS iliyodhibitiwa na inakusudia kuendelea kushiriki katika mchakato wake wa fluorination, OECA ilirejelea utekelezaji kwa Idara ya Sheria (DOJ) na DOJ ilifungua kesi kwa niaba ya EPA dhidi ya Inhance mnamo Desemba 2022. "Kama ilivyoelezwa katika taarifa ya EPA ya Desemba 30, 2020, ""Kwa kuzingatia SNUMs na kulingana na Mfumo wa Kukabiliana na PFAS Mpya na Matumizi Mpya ya PFAS, EPA iliamua kwamba PFAS tatu (PFOA, perfluorocyanic acid, na perfluorocyanic acid) ni sumu sana na zina hatari zisizo na sababu ambazo haziwezi kuzuiwa isipokuwa kwa kupiga marufuku utengenezaji.""" "Kwa hivyo, chini ya kifungu cha 5 (f) cha TSCA, EPA inakataza kuendelea kutengeneza PFOA, PFNA na PFDA ambazo hutengenezwa kutoka kwa fluorination ya HDPE. """ "EPA pia iliamua kwamba kemikali sita zilizobaki kati ya tisa za PFAS zinazotengenezwa na Inhance zinaweza kuanzisha hatari isiyo ya busara ya kuumiza afya au mazingira na, chini ya kifungu cha 5 (e) cha TSCA, inahitaji kampuni hiyo kuacha utengenezaji wa kemikali hizi, na kufanya majaribio ya ziada ikiwa inakusudia kuanza tena uzalishaji. """ Inhance's Fluorine Process kwa plastiki inazalisha kemikali zote tisa za PFAS zinazohusika na amri hizi wakati huo huo, pamoja na PFOA, PFNA, na PFDA. Kwa hivyo, uzalishaji wa PFAS sita zingine hauwezi kuanza tena kwa muda mrefu kama mchakato wa fluorination unaendelea kutengeneza PFOA, PFNA na PFDA. Amri hizi zinaanza kutumika Februari 28, 2024. <unk> Njia mbadala za mchakato huu wa fluorination zipo ambazo zitawawezesha sekta nyingi kuendelea kutoa bidhaa na ufungaji wa kinga unaohitajika. Inhance imesema inafanya kazi juu ya mabadiliko ya mchakato wake, na lengo la kuondoa uzalishaji wote wa PFAS, kulingana na EPA. "Kama kawaida, EPA itachunguza chaguzi za kuhakikisha kufuata maagizo, kulingana na sera zake za utekelezaji, ama kupitia kesi zaidi au makubaliano sahihi, ""kwa mujibu wa taarifa ya Shirika hilo." "EPA pia inabainisha kwamba TSCA hutoa msamaha kwa madhumuni ya ulinzi wa kitaifa. """