No Objection Letter for Recycled Plastics #93
February 17, 2005
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 November 19, 2003, requesting on behalf of your client, United Resource and Recovery Corporation, our opinion regarding the capability of their secondary recycling process to produce post-consumer recycled (PCR) polyethylene terephthalate (PET) suitable for use in food-contact applications. This PCR-PET would be used to manufacture food-contact articles for use with all types of food under Conditions of Use B through H as defined in 21 CFR 176.170, Table 2 with the inclusion of non-food PET containers in the feedstock. This request has been entered into our files as CTS 86592.
As pointed out in your letter, this recycling process has previously been the subject of a no-objection letter (NOL) dated February 1, 2000. The February 1, 2000 NOL was for United Resource and Recovery Corporation to produce PCR-PET for contact with aqueous, acidic, and low-alcohol containing foods at room temperature and below (Conditions of Use E through G) with the inclusion of non-food containers in the feedstock. This NOL was a result of surrogate testing data submitted by United Resource and Recovery Corporation on November 30, 1998 and January 14, 1999, as well as correspondence from Keller and Heckman dated December 28, 1998 (CTS 63051).
In order to support the expansion in conditions of use as well as the expansion to all food types requested in CTS 86592, you performed migration calculations based on data previously submitted in CTS 63051. Based upon our review of this approach we have concluded that United Resource and Recovery Corporation's recycling process, as presented in CTS 63051 and CTS 86592, 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 B through H as described in Table 2 in 21 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 63051 and CTS 86592. If United Resource and Recovery Corporation's recycling process is modified, new data would need to be evaluated.
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