No Objection Letter for Recycled Plastics #83
August 14, 2003
Ralph A. Simmons
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Dear Mr. Simmons:
This letter is in response to your inquiry of June 12, 2003, requesting on behalf of your client, Pure Tech Plastics, our opinion regarding the capability of their secondary recycling process to produce post-consumer recycled (PCR) polyethylene terephthalate (PET) suitable for use in manufacturing food-contact articles for use with all types of food under conditions of use C through G when non-food PET containers are included in the feedstock. This request has been entered into our files as PNC 218 and is a follow up to your submission of February 21, 2003 (CTS 83498) and Pure Tech Plastics' submission of September 23, 2002 (CTS 82729).
As pointed out in your letter, the requested opinion would be an extension to a previously issued letter of no objection from the FDA, dated October 2, 1998, for Pure Tech Plastics to produce PCR-PET for contact with aqueous, acidic, and low-alcohol containing foods at room temperature and below when the PCR feedstock consists only of food-contact PET containers. This no objection letter was a result of data submitted by Pure Tech Plastics on September 15 and December 18 of 1995, April 17, 1996, and March 3, November 11, and November 21 of 1997.
We have evaluated the surrogate testing information in conjunction with the combined experimentally determined and modeled migration data submitted in PNC 218 combined with data from your previous submissions. The addition of further processing stages to Pure Tech Plastics' recycling process results in a recycled PET product of higher purity then that evaluated for the 1998 no objection letter.
Based upon our review of these data, we have concluded that Pure Tech Plastics' recycling process is capable of reducing the contaminant level in recycled PET below FDA's threshold of regulatory concern. This conclusion covers the use of PCR-PET with all food types under Conditions of Use C through G as described in Table 2 in CFR 176.170 when the feedstock consists of food and/or non-food containers, provided the PCR-PET complies with 21 CFR 177.1630 and any other applicable regulations. Please note that our conclusion applies only to PCR-PET containers obtained from deposit and curbside recycling programs (i.e., feedstock would not include industrial PET containers such as 55 gallon drums that had previously held chemicals) and processed by the method described in CTS 82729 and discussed in CTS 83498 and PNC 218. If Pure Tech Plastics' recycling process is modified, new data would need to be evaluated.
Although we have concluded that the recycling process described in the above submission will produce PCR-PET that is acceptable for the intended use, you should be aware that we are currently developing a formal policy on the use of post-consumer recycled plastics in contact with food. Thus, the decisions set forth in this letter may need to be modified due to future deliberations on this matter.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Paul Honigfort, Ph.D.
Consumer Safety Officer,
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition