{"id":10492,"date":"2021-08-09T09:30:04","date_gmt":"2021-08-09T14:30:04","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=10492"},"modified":"2021-08-09T10:21:55","modified_gmt":"2021-08-09T15:21:55","slug":"fda-acts-on-fluorinated-plastic-packaging","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2021\/08\/09\/fda-acts-on-fluorinated-plastic-packaging\/","title":{"rendered":"FDA acts on fluorinated plastic packaging. What are next steps?"},"content":{"rendered":"

Tom Neltner<\/a>, Chemicals Policy Director and Maricel Maffini, consultant<\/em><\/p>\n

The Food and Drug Administration (FDA) took an important step<\/a> last week to protect food from PFAS contamination from plastic packaging. On August 5, the agency sent a letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles reminding them that these articles must be made under specific conditions to comply with existing regulation or otherwise the food contact articles \u201care not lawful.\u201d Therefore, the food that contacted them should not be permitted for sale. The agency gave three examples of manufacturing processes that do not comply with the regulation. We flagged concerns with fluorinated plastic packaging in a July blog<\/a> and applaud the agency for this action.<\/p>\n

This significant first step needs to be followed:<\/p>\n

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  1. Investigate the companies that provided fluorinated plastic packaging for food and cosmetic uses to determine whether their products complied with the law. If not, then alert food manufacturers and retailers so they can recall the adulterated food and cosmetics.<\/li>\n
  2. Reassess whether the process FDA approved in 1983 for fluorinating polyethylene generates PFAS and whether it should still be considered safe.<\/li>\n<\/ol>\n

    Investigate companies that provided fluorinated plastic packaging<\/strong><\/h3>\n

    In the letter, FDA\u2019s Office of Food Additive Safety (OFAS) states that \u201cavailable information indicates that some manufacturers of fluorinated polyethylene produce articles via alternative manufacturing methods from that stipulated in FDA\u2019s regulation.\u201d It identified three specific examples and says that \u201cthese alternative processes for fluorination of polyethylene are not compliant with 21 CFR \u00a7 177.1615<\/a>, and are not lawful for use in food contact articles.\u201d The three examples of unlawful manufacturing processes are:<\/p>\n

      \n
    1. \u201cFluorination of polyethylene for non-food uses may occur during the fabrication or molding of the container.\u201d<\/li>\n
    2. \u201cUse of fluorine gas in combination with other inert diluents such as carbon dioxide, helium, or argon.\u201d<\/li>\n
    3. Incorporation of oxygen into the fluorinating mixture to modify the properties of the final container.<\/li>\n<\/ol>\n

      A market search shows several brands that have in-mold fluorination of high-density polyethylene (HDPE),\u00a0and another<\/a> that may use oxygen or other gases in combination with fluorine.<\/p>\n

      With the letter public, FDA\u2019s Office of Regulatory Affairs (ORA), which handles field inspections and sampling for the agency, should ensure compliance by food manufacturers all along the supply chain. Where it finds a violation, it would manage the recall of the adulterated food.<\/p>\n

      Reassess whether the allowed use generates PFAS and should still be considered safe<\/strong><\/h3>\n

      About a week before FDA sent out the letter, the agency responded to our May 2021 FOIA request for the documentation that resulted in its 1983 approval of fluorinated polyethylene packaging at 21 CFR \u00a7 177.1615<\/a>. The approval came in response to a 1979 food additive petition by Union Carbide.<\/p>\n

      As with most of FDA\u2019s FOIA responses, the 233-page document has extensive redactions of health and safety information. However, two things come through clearly:<\/p>\n

        \n
      1. Nitrogen and fluorine only: <\/strong>In its petition and communications with FDA, Union Carbide was inconsistent when it explained whether nitrogen was only an example of an acceptable inert gas. FDA scientists demanded clarity and the company agreed that only nitrogen would be allowed. In its recent letter, FDA reminds companies that only this condition is approved.<\/li>\n
      2. Fluorinated organics<\/strong>: The petition included studies of the chemicals that migrated into a simulated food such as water or alcohol. The study evaluated the residue that remained after the food simulant was evaporated off. Union Carbide maintained that fluorine in the residue was almost entirely ionic fluorine \u2013 the kind added to toothpaste \u2013 and showed that the exposure was within tolerated levels. FDA scientists kept pushing back explaining that there was evidence the residue contained substances with a carbon-fluorine bond \u2013 a indicator of what we now refer to as PFAS. FDA finally relented, stating that \u201cour general conclusion is that low molecular weight fluorocarbon-oxygen compounds should not be present in significant quantities.\u201d (see page 195 of FOIA response).<\/li>\n<\/ol>\n

        We now know that levels of PFAS that were considered insignificant by FDA in the 1980s pose significant risks as evidenced by some of the agency\u2019s recent actions<\/a>. For those reasons, we reaffirm our call in our July 2021 blog<\/a> and in the June 2021 citizens petition<\/a> submitted by 11 organizations to FDA to reassess the safety of PFAS uses, including fluorinated polyethylene.<\/p>\n

        As part of that reassessment, FDA needs to revisit the concerns raised by the agency scientists in 1983 in light of the risks posed by PFAS. Specifically:<\/p>\n