Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Premarket Approval⁺
April 20, 2001

No Objection Letter for Recycled Plastics #65

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

April 20, 2001

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

Dear Mr. Simmons:

This responds to your inquiry of August 7, 2000, requesting on behalf of your client, Plastic Technologies, Inc., an opinion from FDA expanding the permitted use of recycled PET produced by one of two methods (designated recycling processes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ) to include Conditions of Use B-H ("Boiling water sterilized" through "Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use"). These two methods were the subject of a submission dated February 24, 1997, which you enclosed. As pointed out in your letter, FDA previously issued letters of no objection dated August 10, 1999, for these recycling processes to produce recycled PET for use in contact with dry (no surface fat or oil), aqueous, acidic, and low-alcohol (15% or less) foods at room temperature and below, provided the post-consu mer recycled PET (PCR-PET) comes from containers previously used for food and non-food applications (excluding industrial PET containers) obtained from deposit and curbside recycling progams, and the recycled PET complies with 21 CFR 177.1630.

We have reviewed the information submitted in which you have calculated the increase in migration of the surrogate contaminants into food simulants from the boiling water sterilization step (2 hours at 100°C) above the amount of migration that was previously measured at 40°C. Based on our review of these data, we conclude that the levels of exposure to possible contaminants resulting from the expanded use of PCR-PET that was produced by one of the two methods described in your February 24, 1997, submission would be below FDA's threshold of regulatory concern. Therefore, we conclude that these two recycling processes will produce PCR-PET that is acceptable for use in contact with dry (no surface fat or oil), aqueous, acidic, and low-alcohol (15% or less) foods under Conditions of Use B-H, provided the PCR-PET complies with 21 CFR 177.1630. Our conclusion applies only to post-consumer PET containers obtained from deposit and curbside recycling programs and processed by either of the two methods described in the February 24, 1997, submission. If your recycling processes are modified, new data would need to be evaluated.

Although we have concluded that the intended use of PCR-PET that has been collected and processed by these two methods 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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