At its core, the process of manufacturing polymeric products involves the conversion of a given resin into a desired form, typically using an extrusion process.\u00a0 These resins, including PTFE, ETFE, FEP, and PFA, are supplied by resin manufacturers, and subsequently converted into their desired form by a polymeric product manufacturer, such as Zeus. Confusion surrounding this process, particularly the involvement of PFAS, has led to various environmental safety concerns in recent years. Zeus is very much in tune with environmental matters and has taken this opportunity to shed some light on these concerns, specifically those regarding the safety of PFAS as it pertains to fluoropolymer products.<\/p>\n
In the year 2000, the U.S. Environmental Protection Agency (EPA) became concerned with perfluorooctanoic acid (PFOA), a chemical that was widely used as a processing aid to manufacture polytetrafluoroethylene (PTFE) and other fluoropolymers.\u00a0 As a response, the fluorochemical industry signed an agreement with the EPA<\/a> to remove PFOA from emissions and products by 2015 [1].\u00a0 In addition to PFOA, another chemical, perfluorooctane sulfonate (PFOS), was also eliminated.\u00a0 Even prior to the elimination of PFOA and PFOS, suppliers within the fluorochemical industry were assuring that only trace amounts of PFOA and PFOS were present in their fluoropolymer resins, and that during the resin suppliers\u2019 manufacturing processes, the processing aids were washed out of the resin.\u00a0 Additionally, suppliers shared that these chemicals were destroyed at high temperatures, with typical fluoropolymer processing temperatures far exceeding this threshold [2].<\/p>\n Recently, however, new concerns have surfaced regarding the processing aids used to replace PFOA and PFOS.\u00a0 All of these processing aids belong to a group of materials known as perfluoroalkyl substances and polyfluoroalkyl substances, or PFAS for short.\u00a0 The absolute broadest definition of PFAS includes polymeric poly-fluoroalkyl substances or fluoropolymers, like PTFE.\u00a0 However, the PFAS of concern to the EPA are the non-polymerized forms.\u00a0 Polymers do not behave like the non-polymerized small molecules. \u00a0Polymers are very long molecules with very high molecular weights.\u00a0 For example, the molecules in PTFE resin have between 10,000 and 180,000 carbons linked together to make a chain.\u00a0 In contrast, the non-polymerized PFAS have 4 to 12 carbons linked together.\u00a0 Because long chains do not move as easily as their much smaller counterparts, polymeric materials have much different properties than non-polymeric materials. This difference can be seen when comparing the properties of polyethylene, a solid plastic polymer used for grocery bags, and ethylene, a flammable gas.\u00a0 The polyethylene used in grocery bags has chains with between 3,500 and 14,300 linked carbons whereas the ethylene has two linked carbons. \u00a0\u00a0So while both fluoropolymers and these processing aids belong to the broadest PFAS classification, their properties are very different.\u00a0 Because of these significantly differing properties, the safety of fluoropolymers should be evaluated independently from non-polymerized forms of PFAS.<\/p>\n In 2015, a report commissioned by the European Commission provided criteria for a polymer to be considered \u201ca Polymer of Low Concern\u201d, or PLC [3]. \u00a0Dr. Henry et al. published an article in 2018 that shows how PTFE, ETFE, FEP, and PFA meet these requirements to be considered a Polymer of Low Concern<\/a> [4].\u00a0 As part of this work, commercially available PTFE resin was placed in isopropanol to pull out or extract any fluorinated processing aids.\u00a0 The isopropanol was then analyzed and it was determined that no common fluorinated processing aids were detected at the parts per billion threshold [5].<\/p>\n Further supporting this low concern designation, fluoropolymers have been approved for use in applications such as food packaging, pharmaceutics, and medical devices.\u00a0 These applications require approval from an independent regulatory body, such as the U.S. Food and Drug Administration or European Food Safety Agency. \u00a0There are several standards that are used to determine if a material is safe to use in a particular application.\u00a0 For example, ISO-10993 and U.S. Pharmacopeia Class VI Standards both outline biocompatibility testing protocols and requirements for certification.\u00a0\u00a0 These standards include requirements for determining the impact of any leachable or extractable material.\u00a0 There has also been data published that demonstrates that fluoropolymers do not degrade in the environment or release substances of toxicological or environmental concern [4-8].\u00a0 Zeus is able to produce fluoropolymer products that meet the USP-Class VI standard, and more information can be found here: https:\/\/www.zeusinc.com\/resources\/summary-material-properties\/biocompatibility\/<\/a><\/p>\n The supplier information and published studies regarding fluoropolymers support the position that PTFE and other fluoropolymer resins are of low concern and unlikely to release PFAS.\u00a0 Furthermore, Zeus\u2019 processing of fluoropolymer resins at temperatures above processing aids\u2019 destruction threshold and the ability to produce biocompatible parts for medical devices further bolsters this conclusion.\u00a0 Based on these rationales, we firmly believe that fluoropolymer products produced at Zeus facilities are unlikely to contain or release PFAS of concern.<\/p>\n Additional information regarding Zeus\u2019 position on the safety of PFAS can be found here<\/a>.<\/p>\n References:<\/p>\n At its core, the process of manufacturing polymeric products involves the conversion of a given resin into a desired form, typically using an extrusion process.\u00a0 These resins, including PTFE, ETFE, FEP, and PFA, are supplied by resin manufacturers, and subsequently converted into their desired form by a polymeric product manufacturer, such as Zeus. Confusion surrounding…<\/p>\n","protected":false},"author":27,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-4687","post","type-post","status-publish","format-standard","hentry","category-other"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/posts\/4687","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/users\/27"}],"replies":[{"embeddable":true,"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/comments?post=4687"}],"version-history":[{"count":0,"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/posts\/4687\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/media?parent=4687"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/categories?post=4687"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.zeusinc.com\/wp-json\/wp\/v2\/tags?post=4687"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n