No Objection Letter for Recycled Plastics #89
July 13, 2004
Mr. Ralph Simmons
Keller and Heckman, LLP.
1001 G Street, N. W.
Washington, D.C. 20001
Re: Prenotification Consultation (PNC) 264
Dear Mr. Simmons:
This letter is in response to your inquiry of June 19, 2003, requesting on behalf of your client, Pure Tech Plastics, our opinion regarding the elimination of the | | | | | | | | | | | | | | | |. step from their secondary recycling process used to produce post-consumer recycled (PCR) polyethylene terephthalate (PET). This PCR-PET would then be used to manufacture food-contact articles for use with all types of food under conditions of use C through G with the inclusion of non-food PET containers in the feedstock. This request has been entered into our files as PNC 264.
As pointed out in your letter, this secondary recycling process, with the inclusion of the | | | | | | | | | | | | | | | |. step, had previously been the subject of two no-objection letters (NOLs) dated October 2, 1998 and August 13, 2003. The October 2, 1998, NOL was 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 NOL 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. These conditions of use were further expanded under the August 13, 2003 NOL to include all food types under Conditions of Use C through G as described in Table 2 in 21 CFR 176.170 when the feedstock consists of food and/or non-food containers. This NOL was a result of additional data submitted by you on June 12, 2003 (PNC 218) and February 21, 2003 (CTS 83498) as well as Pure Tech Plastics' submission of September 23, 2002 (CTS 82729).
We have evaluated the provided surrogate testing data and surrogate removal calculations for each step of Pure Tech Plastics' recycling process. In conjunction with this information we have also reviewed the refinements applied to the residual surrogate levels determined in the finished solid-stated PET to account for the extremely high surrogate concentrations in the starting challenged flake. The migration modeling subsequently utilized to determine the resultant dietary concentrations of the surrogate chemicals was also evaluated.
Based upon our review of these and previously submitted data, we have concluded that Pure Tech Plastics' recycling process as presented in PNC 264 (without a | | | | | | | | | | | | | | | |. step) 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 PNC 264. If Pure Tech Plastics' 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