How FDA Requires Food-Grade Recyclers to Prove That They Can Clean Recycled Plastic

This is an overflow from my last installment about testing of recycled plastic and the misinterpretation of that information. I promised that I'd include details about how recyclers have to clean plastic to get approval from FDA to sell it as food grade so here's that:

Even though food-grade, “natural” meaning undyed, plastics can be quite easily recognized and sorted, the FDA recognizes that a consumer could use a milk bottle to hold something else after being emptied of its original contents or that it could have contacted some toxin in the environment after being discarded, so they direct recyclers to test that they can wash out chemicals that might have absorbed/adsorbed into/onto the plastic.

This challenge testing is described in this FDA guidance document starting on page 9. To execute the challenge testing, a recycler would take virgin Polyethylene plastic, soak it in a cocktail of nasty chemicals from the given list, chemicals that a consumer could possibly store in a bottle or that might be in a polluted location: toluene, chloroform, etc. (Each chemical category serves as a surrogate for herbicides, pesticides, heavy metals, solvents and some other categories.) They then process per their procedures and see if they can remove the chemicals from the cocktail to below a very low safety threshold or undetectable. If you imagine that a recycler has received ten bales of plastic where every container in that bale was used to store a pesticide, the process they use to clean the plastic has been demonstrated by challenge to be able to remove it. I hope this addresses a suspicion that the FDA is making a “blanket approval.” They are not. They demand that the processor do these challenge tests and submit their entire process with data. Only after review of their specific process, which proves that they can eliminate toxins that might possibly be in their feedstock, do they issue the Letter of Non-Objection.

It’s at this point that I have to continue to explain how the FDA talks. In natural language “Non-Objection” sounds like the weakest thing in the world, a bureaucratic nothing burger, but it’s not in the context of the FDA and how they have to oversee things. The FDA can only use strong language to enforce laws that have been passed by congress. They cannot use strong language to enforce their own bureaucratic rules. But science, pharmacy and food innovations come so fast that there is a zero percent chance that a law passed in 1970 or even 2022 could adequately cover the thousands of fine points they need to regulate to protect our health. Therefore, when the FDA approves or bans things, they do so by rule and they can only talk about their rules in terms of not objecting. I used to run a plant that made most of the white-label peptic in the country and much of the liquid children’s cough-cold medication. Periodically, the FDA would want to change label text. They do not want producers freelancing the label warnings because they actively want people to have these medications in their pantries. (It’s estimated that these medications save billions of dollars every year in skipped hospital visits and avoidance of lost productivity, mainly for women, and that they save many children’s lives, in the case of anti-febrile medications delivered on time to prevent high fevers.) They also want to make sure that approved warnings are on labels in exactly the wording they want. But when you get a label change directive from the FDA, they don’t say, “Put “XYZ” warning text on your label. They say, “The agency will not object if you add a label reading, ‘XYZ’ to your medication. It should appear in no less than 8 point font…” If you do not make this label change by the date prescribed in the exact font size, the FDA, in their shelf grabs from retailers, will catch it and issue you a Warning Letter. If you ignore that, they will elevate the enforcement until they shut you down. So when the FDA says they "do not object," it means that they have done their due diligence and approve of something / mandate something.

I hope this communicates the gravity behind the FDA oversight of the processing required to sell food-grade recycled plastic.