Recycle Clearances Part 2/3: Surrogate Contaminant Test

Our latest Assurance in Action podcast is the second in a three-part series that will explore recycle clearances in the United States and Europe applicable when using recycled resins in food contact applications and conducting the “the Challenge Test”. This episode focuses on the Surrogate Contaminant Test.  To learn more about “the Challenge Test”, stream our podcast now.

Speakers:

• Mason Myers- Manager of Recycle Notification Projects, Intertek Assuris
• Lennard (Lenny) Edwards - Project Manager, Intertek Assuris

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Transcript

00:17 --> 01:02
 Speaker 1

Script

Hi everyone! Welcome back to the Assurance in Action podcast, where we are hosting a special podcast series about recycle clearances. Today’s episode is part two out of three, where we will be focusing on the Surrogate Contaminant test (aka, the “Challenge Test”) and dive into some common questions surrounding this testing. Thank you for joining us today. 

My name is Mason Myers. I am the Manager of Recycle Notification Projects here at Intertek, and today I am sitting with Lennard (“Lenny”) Edwards, who is a Project Manager and Intertek’s very own Challenge Test Expert. Lenny is going to share with us an overview of the Challenge Test and share some questions that are typically asked about this specific type of test. Thanks for joining us today, Lenny.

01:02 --> 01:06
 Speaker 2

Thank you, Mason. Happy to be here today. 

01:06 --> 01:09
 Speaker 1

Let’s dive right in shall we? Where would you like to start?

01:09 --> 02:07
 Speaker 2

I think a quick refresher on vocabulary is a good place to start! 

The FDA provides definitions of each of the three types of recycling processes in their recycle guidance document:

•                     Primary recycling refers to pre-industrial, or pre-consumer, scraps and salvage to form new packaging, a common practice in the industry;

•                     Secondary (also called mechanical recycling) refers to the physical reprocessing through grinding, melting, and reformation of post-consumer recycled materials. This type of recycling is the most common and what people typically refer to when discussing recycling;

•                     Tertiary (also called chemical or advanced recycling) refers to breaking down the resin via a chemical process back into the original building blocks of the polymer and purifying the monomer. Often the recycled monomers are repolymerized back into the same polymer.

02:07 --> 02:15
 Speaker 1

Thanks for the refresher! I’m guessing some of those processes are involved with the Challenge Test?

02:15 --> 02:44
 Speaker 2

You guessed it. Both secondary and tertiary recycling processes are applicable to the Challenge Test. Primary recycling, abbreviated PIR, doesn’t require a challenge test since this kind of material and recycle process generally doesn’t experience the same type of incidental contamination that post-consumer recycled, or PCR, materials experience, which are associated with secondary and tertiary recycling. 

02:44 --> 02:48
 Speaker 1

Ok, can you share with our listeners what exactly is a Challenge Test?

02:48 --> 03:50
 Speaker 2

Sure thing. The Challenge Test is officially called the Surrogate Contaminant Test. This test is performed on a recycling process to determine the efficacy rate of removing incidental contamination in recycled materials. 

The FDA recommends simulating consumer misuse by exposing virgin polymer (either in container form or flake form) to selected surrogate contaminants and then running the exposed or “challenged” polymer through the recycling process. This demonstrates the ability of a 2° (secondary) or 3° (tertiary) recycling process to remove contaminants from plastic containers or packaging that have been subjected to consumer misuse or abuse (an example would be storage of pesticides or automotive chemicals in a milk jug). Analyzing the processed polymer for the surrogate contaminants would allow you to evaluate the efficacy of the recycling process.

03:50 --> 03:56
 Speaker 1

Would I be correct that this information is in a document somewhere that people can access?

03:56 --> 04:39
 Speaker 2

Yes, of course. The FDA provides this information in a guidance document specific for recycled plastics. It’s called, “Use of Recycled Plastics in Food Packaging (Chemistry Considerations): Guidance for Industry” and the latest version (or update) was in July 2021.

To access it, you can simply google “US FDA recycle guidance” and click on the first link you find, which is the FDA website. It will take you to the landing page for the recycle guidance document. Then you click on the “Download the Final Guidance Document” button to access the actual guidance document. This document is specific for recycled plastics in food packaging. 

04:39 --> 04:45
 Speaker 1

That is important for our listeners – and it sounds easy to find. So what’s next in this process?

04:45 --> 04:59
 Speaker 2

Well, let’s answer that by talking about Intertek’s capabilities pertaining to doing the Challenge Test, and how we help recyclers complete this requirement for a NOL, aka “no-objection letter,”  submission.

04:59 --> 05:01
 Speaker 1

Sounds great – take it away!

05:01 --> 05:51
 Speaker 2

Intertek supports recyclers all over the globe with addressing this Challenge Test requirement for NOL submissions. Over the past years we’ve developed the largest capacity, in terms of production volumes, of contaminating material in the industry. Support for our challenge test lab is within our own Intertek network of labs, and our challenge test lab is located in Fort Lauderdale, Florida. Right now, our current capacity is approximately 1300 pounds of materials within a two-week period. We’ve developed this high-volume throughput to support recyclers who run their Challenge Test on commercial scale lines. That kind of scale usually requires several hundred pounds of material to saturate their feed rates, and we can support that kind of volume pretty well. 

05:51 --> 05:58
 Speaker 1

Wow – you said about 1300 pounds in two weeks. That is a lot of material. How often are you doing those larger volume Challenge Tests?

05:58 --> 06:27
 Speaker 2

They are happening quite often. With more and more recyclers trying to obtain an NOL for their recycling processes, it currently makes sense to complete these Challenge Tests on a commercial scale. We can actually support higher volumes than 1300 pounds – we’ve even contaminated 1 ton of material (and that’s 2200 pounds!) for a few clients. During the planning phase of the challenge test, we update the lab schedule and advise on how long it will take to do larger orders as well. 

06:27 --> 06:31
 Speaker 1

Can you walk us through what you do for a Challenge Test?

06:31 --> 08:40
 Speaker 2

Well, we follow the FDA’s recycle guidance challenge test protocol to set up our tests, and the first step is to collect all the necessary info to plan the challenge test appropriately. 

To start, we need some information upfront, such as:

•                     What kind of recycling process are we going to be performing the challenge test on?

•                     How much volume is required? We can help guide the client to figure this out if needed; 

•                     What surrogate contaminants will be used? Intertek has standardized surrogate contaminants we commonly use, but we are open to working with the client with their desired ones. The FDA recycle guidance provides several options. We can even help choose other alternate surrogate contaminants not mentioned in the guidance document, and we work with the recycler and the FDA to make sure they are appropriate for the test.

Then, we collect all the necessary information to ship the challenged material anywhere in the world. We can support international transport of the challenged material and help with logistics as needed.

Lastly, there is also the analytical portion of the Challenge Test. We typically recommend the minimum requirement by the FDA in terms of sample size, which is at least two  samples. One is a pre-recycled, post-contaminated sample - used to determine the contamination levels of each surrogate contaminant after it’s soaked for two weeks to establish the base line level. The second sample comes from the recycler as a representative sample collected from the post-contaminated, post-recycled material, to compare back to the 1st sample. This is how you determine how much of the contamination was reduced to know if you meet the FDA requirements. 

We work with each recycler to determine the correct type of sampling protocol and analytical profile for the recycling process. Sometimes, we’ve seen a recycler want to do a robust sampling type so they have a lot of data to understand their recycling process in detail. And we can support that as well.

08:40 --> 08:46
 Speaker 1

There’s a lot of information involved, isn’t there? So when you have all that information, what’s next?

08:46 --> 10:19
 Speaker 2

By the time we have this information collected, we usually have a signed contract from the recycler to complete a challenge test. This is usually included in our NOL submission projects, but we offer just the challenge test services if needed as well. Both methods require a signed contract.  

Once we have a signed contract and all the supporting information, Intertek will secure the amount of material and chemicals required to do the test. We can either accept the material from the recycler—‍which is preferred, as it is already in flake form which works best for the recycling system—‍and if that isn’t an option, we can purchase the material on the market to be used for contamination. We also confirm the number of cycles it will take to contaminate and the anticipated completion date of when we will ship the material to the address provided. These logistics are usually addressed once we have the material packaged up and ready for pickup by the shipping company. We typically work with FedEx, but can work with any shipping logistics company preferred by the client. 

Once the recycler receives the challenged material, they will need to run it through their recycling process. We ask the client to send us back a representative sample they’ve collected at the end of the process of the challenged material. After we receive the sample, we forward everything to our analytical lab in Pennsylvania and return the data as soon as it’s available. The analytical lab that processes the challenged samples typically returns the data in about 20-30 days after they receive the sample. 

10:19 --> 10:43
 Speaker 1

Ok, so let’s do a quick recap here. So far you explained the three different types of recycling processes, a high-level intro to what a challenge test is, where people can go to access the FDA’s guidance document on how to complete the challenge test, what info Intertek needs to setup a challenge test, how long the challenge test takes, and analytical testing  . Did I miss anything?

10:43 --> 10:48
 Speaker 2

No you did not ! Glad I didn’t lose you

10:48 --> 10:58
 Speaker 1

Excellent. You were telling me before we started recording that you have a list of frequently asked questions (FAQs) pertaining to the Challenge Test. Would this be a good time to hear what those are?

10:58 --> 11:08
 Speaker 2

Yes, let’s do that! What I’ll do is share some of the common questions that Intertek gets from recyclers about the Challenge Test and then respond to that question, if that works with you.

11:08 --> 11:10
 Speaker 1

Go for it!

11:10 --> 13:03
 Speaker 2

Great. So here are some of the common questions we get.

Question 1: Why and when is a challenge test needed?

A challenge test is required by the FDA for most NOL submissions when secondary and tertiary recycling processes are involved; however, there are some exceptions. Intertek can help review your situation on a case-by-case basis and provide you with the right guidance. 

Question 2: What is the maximum level of contamination acceptable in recycled polymer?

Simple: this question is addressed in the FDA Recycle Guidance document. The document lists the max level of each polymer type.

Question 3: Do the surrogate contaminants fully soak into the entire material?

No, the contaminant doesn’t soak through the entire material. It is absorbed through the surface and penetrates just a few microns in. So it’s considered “surface level” contamination. 

Question 4: How much analytical  testing is required for a Challenge Test? 

Simple answer: It varies. Usually,  you start off with residual analysis, measuring for each surrogate contaminant remaining in the polymer. This represents the worse-case scenario of an 100% migration of the remaining surrogate contaminant. 

If any of those results exceed the threshold mentioned in the guidance document, that can trigger additional testing such as migration modelling or a migration study to refine the results. Starting with residual analysis lets you know if additional testing is needed. We always review the results and let you when additional testing is recommended. 

And that wraps up the most common questions we get!

13:03 --> 13:37
 Speaker 1

What useful info – thanks for sharing that with our listeners, Lenny. We’ve now come to the part of this podcast episode where we thank our listeners for joining us today and sharing this time with us to go over The Challenge Test for todays topic. Our last and final episode in this mini-podcast series will cover the topic of European recycle regulations associated with the new recycle framework regulation EU 1616/2022. Keep a watchful eye out for that episode and we look forward to talking with everyone soon. Until next time!

13:37 --> 13:39
 Speaker 2

Thank you, Mason!