Recycle Clearances in the United States: Part 1/3

FOOD CONTACT INDUSTRY SERIES

Our team Assuris is excited to kick off a new podcast series! Our latest Assurance in Action podcast is the start of 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”. To learn more about recycle clearances, stream our podcast now

Speakers:

• Mason Myers- Manager of Recycle Notification Projects, Intertek Assuris
• Chloe Lay- Project Manager, Intertek Assuris

Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.

Transcript

00:16 --> 00:58
 Speaker 1

Hi, everyone! Welcome to the Assurance in Action podcast. More specifically, welcome to the first episode in our special podcast series about recycle clearances. This is going to be 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 “Challenge Test”. We are very excited to bring this new podcast mini-series to you. Today’s episode will focus on recycle clearance in the United States.

My name is Chloe Lay. I am a Project Manager here at Intertek, and today I am sitting with Mason Myers, Manager of Recycle Notification Projects, who is going to help us dig into this very intriguing topic. 

00:58 --> 01:02
 Speaker 2

Thank you, Chloe. Happy to be here today.

01:02 --> 01:12
 Speaker 1

So, to get started, Mason, how are recycled resins intended to be used in food contact materials and articles regulated in the U.S., and who’s in charge of overseeing this?

01:12 --> 02:12
 Speaker 2

At this time, the U.S. Food and Drug Administration (aka, the FDA) is the governmental agency in the U.S. that evaluates recycled resins for the use in food contact applications. Recycled resins to be used in food applications are not specifically regulated, but they are evaluated by a voluntary program called “No-Objection Letters” (commonly abbreviated as NOL, LONO, or LNO). 

This program began in the 1990s and has been active since. Today there are over 300+ published NOLs. Some examples of the kinds of resins you can obtain an NOL for include polyethylene terephthalate (or PET), Polystyrene (or PS), Poly-vinyl chloride (or PVC) and Polyolefins such as Polypropylene (or PP) and Low-density and High-density Polyethylene (or LDPE and HDPE).

02:12 --> 02:20
 Speaker 1

Hmm, that’s super interesting Mason. Can you explain what an NOL is and what it does?

02:20 --> 02:37
 Speaker 2

An NOL is an opinion letter, issued by the FDA, that evaluates the ability of a recycling process’s efficiency in removing incidental contamination. It does not grant food contact approval and it is not part of a regulation. 

02:37 --> 02:49
 Speaker 1

Okay, so the FDA has a voluntary program for evaluating recycled resins that are intended to be used in food. If the program is voluntary, why would a recycler be interested in getting an NOL?

02:49 --> 03:52
 Speaker 2

Great question, Chloe. The NOL program, although considered voluntary as we know it today, is a way to have recycled resins be reviewed by a trusted government organization that also is in charge of evaluating and regulating virgin grade resins that are intended to come into contact with food. Most recycled resins are collected from post-consumer recycled, or PCR sources, meaning materials that have been used in their original purpose and collected, or “recycled”, and sent to a facility to sort, process, and separate from other materials and ship to recyclers all over the U.S. for further processing. 

By having the FDA evaluate the recycling process, this provides a level of assurance to members of the food contact industry when introducing recycled resins into food contact applications. These materials have been already evaluated and determined to be safe for intended uses in those food applications. 

03:52 --> 04:02
 Speaker 1

Ah, I can see then why a recycler would want to obtain an NOL. You mentioned there are several hundred published NOLs—where can you go to access them?

04:02 --> 04:44
 Speaker 2

The FDA has a free online database that it publishes and updates periodically, listing the successful NOLs it has granted to recyclers. It’s easy to find – you can go to Google and search for “U.S. FDA NOL Database” and click on the first link. You’ll be taken to the FDA’s website called “Recycled Plastics in Food Packaging”, and at the bottom there is a button that says, “Recycled Plastics Database”. The official name of the database is called “Submissions on Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles” and includes all successful NOLs granted for PCR materials since the program began. 

04:44 --> 05:03
 Speaker 1

That sounds easy enough! Okay, so far, we covered that the U.S. FDA is in charge of the NOL program, we learned what an NOL is and why they matter, and we now know how to see the published ones. Can you talk a little bit about how you would go about getting an NOL?

05:03 --> 05:46
 Speaker 2

Sure! In simple terms, what the FDA is looking for in an NOL submission would be information like: 

•                     detail about the incoming feedstock that is used in the recycling process, 

•                     a full description of the entire recycling process from start to finish,

•                     analytical data that support the desired end-use applications (meaning the food contact application), 

•                     what types of food the recycled material will interact with, and the temperature range, including the data from a Challenge Test, if required, and 

•                     any other type of supportive evidence that can support the recycle submission.

All this information is compiled into a dossier package that is sent to the FDA for review. 

05:46 --> 05:50
 Speaker 1

Ok, and what happens next?

05:50 --> 07:15
 Speaker 2

Well, the FDA will review the entire dossier package to determine if it meets their requirements to issue an NOL. 

The FDA is not legally required to respond back in a certain time after the NOL has been submitted, unlike other food contact programs they oversee, like the Food Contact Notification (or FCN) program. 

Here is what we typically see: once a submission is made, the FDA will share an “Acknowledgement” Letter within seven business days that confirms they’ve received the electronic submission of the NOL dossier package. 

After that the FDA begins a review period, during which Intertek’s mantra has been “no news is good news”! If the FDA considers the dossier complete with no additional questions or follow up, an NOL clearance is typically received after about four to six months following the “Acknowledgement” letter, in the form of a Pre-Notification Consultation (or PNC) letter. If the FDA has follow-up questions, technical- or administrative-based, they will issue a PNC detailing the questions they have and issue a deadline of when to respond. Once we submit a response, we effectively “rinse-and-repeat” the process: the FDA will acknowledge the reply within seven (7) business days with another Acknowledgement Letter, followed by the same kind of review period I just outlined. 

07:15 --> 07:22
 Speaker 1

And once the FDA issues an NOL, are there any follow up requirements or audits?

07:22 --> 08:08
 Speaker 2

No, not at this time. But everything has an exception. While the FDA does not require any follow-ups or audits once an NOL is issued, there are general rules a recycler should follow regarding their NOL and when to contact the FDA. If a recycler changes their feedstock from what is described in the NOL dossier, modifies the recycling process by changing equipment or processing conditions, and/or expands the end-use applications, food types, or conditions of use, the recycler is advised to contact the FDA regarding the modifications and request feedback. The FDA will review the changes and determine the impact to the existing NOL and whether any additional data are required as a result of the change. 

08:08 --> 08:43
 Speaker 1

This is a really helpful schematic for our listeners on how to obtain an NOL. So, to reiterate, a recycler needs to provide data on their feedstock, the recycling process, food contact applications, supporting analytical data, and submit it to the FDA. The FDA will confirm receipt of the submission via a letter in about a week and if everything is deemed okay, issue the NOL in about 4 to 6 months. If they have questions, they will let the notifier know and request a response. Do they suspend the submission review while they wait for you to respond to their questions?

08:43 --> 08:53
 Speaker 2

Yes, receiving questions from the FDA does suspend the review. They will typically provide a deadline of when to respond, too. 

08:53 --> 09:02
 Speaker 1

Ok, let’s shift focus here. Can you talk a little bit about the level of detail for the info that you said is typically included in the submission?

09:02 --> 10:59
 Speaker 2

Of course. Let’s start with the feedstock. The FDA is looking for details like the original applications that the feedstock was used in, whether the feedstock is coming from food-contact applications, and what pre-sorting and cleaning steps are taken prior to accepting the feedstock. Not all recyclers can collect this information, so it is generally a good idea to work with suppliers as much as possible to obtain this information, but if not everything can be collected, that is fine. The FDA likes to have this information for their review and if additional information is required, they will let you know via the PNC letter. 

For the recycling process, the most important details would be a step-by-step procedure that discusses the entire process from accepting the feedstock on the site all the way to the final packaging of the finished product, ready for shipping. Key things to include would be temperatures, pressures, and residence times where applicable.

Analytical requirements can be unique depending on the types of feedstocks being used for the recycling process and the desired clearance submitted for the NOL. The FDA’s main focus is determining whether the material can meet food contact eligibility. So for example, common resins like PET and Polyolefins are already regulated at the polymer level by the Code of Federal Regulations (aka CFR), Section 21 program. At minimum, 21 CFR testing should be conducted on the incoming feedstock and the final product. Other useful analytical data can be included too – tests like volatile organic compounds, heavy metals, and additive screening. These are more “nice to have” than required, but as we’ve seen, the FDA is the ultimate decision maker, and they will let you know when more analytical data is needed. 

10:59 --> 11:16
 Speaker 1

I heard about the Challenge Test before. We plan to cover the Challenge Test in our 2nd podcast in this series, so maybe we can do a quick introduction here and then our listeners can tune into the next episode to hear more details. Is the challenge test a required analytical test too? What kind of test is it?

11:16 --> 13:10
 Speaker 2

Of course! Intertek uses two terms to talk about an NOL. The first one is a “limited-scope NOL”, which restricts the recycled materials to dry food applications with temperatures ranging from room temperature to cold storage. This type of NOL typically does not require a Challenge Test and usually just needs a 21 CFR test. The second term is a “full scope/expanded scope”, which is any condition beyond limited-scope which does typically trigger a Challenge Test. To be sure, Intertek usually conducts a case-by-case review to determine whether a Challenge Test is required for a submission. 

A Challenge Test is used to evaluate how efficient a recycling process is in removing incidental contamination. You can think of it like a giant spike-and-recovery test , where you put a known amount of a substance in and see how much you get back out at the end. You take virgin grade material and make a cocktail mixture that contains up to five surrogate contaminants that represent various types of incidental contamination. You soak the material for two weeks at an elevated temperature to encourage the absorption of the contaminants. Then the material is processed by the recycler, ensuring that the material is both washed and extruded. A post-recycling sample is then compared to a pre-recycling sample to analyze the results. The U.S. Recycle Guidance Document explains the limits of how much residual contamination can remain in the material after it is fully recycled. The results of the Challenge Test will reveal how effectively the current operations are removing incidental contamination, and will influence what kind of clearance you can submit your NOL for. 

13:10 --> 13:34
 Speaker 1

Wow, thanks for that detailed explanation, Mason. And thank you for taking the time today in general to educate us about recycle clearance in the United States. I think this is a perfect time to break for this episode. 

In our next episode, we will discuss details about the Challenge Test and cover frequently asked questions about it. Thank you again, Mason, for your time today. 

13:34 --> 13:41
 Speaker 2

It was a pleasure to chat with you Chloe. I look forward to future episodes in the series. Until next time!