Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Premarket Approval⁺
February 1, 2000

No Objection Letter for Recycled Plastics #60

Note: Material that is not releasable under the Electronic Freedom of Information Act (EFOIA) has been redacted/deleted from this electronic version of the program. Deletions are marked by a barred out area or hash marks.

February 1, 2000

Ralph Simmons
Keller and Heckman
1001 G. Street, N.W.
Suite 500 West
Washington, DC 20001

Dear Mr. Simmons:

This responds to your letter of December 28, 1998, requesting on behalf of your client, United Resource Recovery Corporation (URRC), confirmation regarding the suitability of a method for recycling polyethylene terephthalate (PET) into food-contact articles intended for use in contact with dry (no surface fat or oil), aqueous, acidic, and low-alcohol (< 15%) foods at room temperature and below. A letter from URRC dated January 14, 1999, states that the source of the feedstock will be pre-consumer plant scrap and PET containers, complying with 21 CFR 177.1630 or 177.1315 and previously used for food and non-food applications, obtained from deposit and curbside recycling programs (i.e., would not include industrial PET containers such as 55 gallon drums that had previously held chemicals).

We have reviewed the information submitted to demonstrate the capability of the URRC's recycling process, | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |  to remove potential contaminants from post-consumer recycled PET (PCR-PET). Based on our review of these data, we conclude that the levels of exposure to possible contaminants resulting from the proposed use of PCR-PET that was subjected to the recycling process described in the subject submission would be below FDA's threshold of regulatory concern. Therefore, we conclude that this recycling process will produce PCR-PET that is acceptable for use in contact with dry (no surface fat or oil), aqueous, acidic, and low-alcohol (< 15%) foods at room temperature and below, provided the PCR-PET complies with 21 CFR 177.1630 or 21 CFR 177.1315. As discussed in our "Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations," the Agency has no objection to recycling industrial scrap and trim to manufacture food-contact articles, providing that the PET complies with existing specifications (i.e., 21 CFR 177.1630 or 21 CFR 177.1315). Our conclusion applies only to pre-consumer plant scrap and post-consumer PET containers obtained from deposit and curbside recycling programs and processed by the recycling process described in the December 28, 1998, submission. If the recycling process is modified, new data would n eed to be evaluated.

Although we have concluded that the intended use of PCR-PET that has been collected and processed by the method described in your submissions is acceptable, 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.

⁺ The Office of Premarket Approval became the Office of Food Additive Safety on June 18, 2001.
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