No Objection Letter for Recycled Plastics #117
July 30, 2008
George G. Misko
Keller and Heckman LLP
1001 G Street, NW
Suite 500 West
Washington, DC 20001
Re: Prenotification Consultation (PNC) 686
Dear Mr. Misko:
This is in response to your submission of April 15, 2008 (PNC 686) (formerly CTS 78267), requesting on behalf of Plastic Technologies, Inc. (PTI) an opinion letter from the FDA regarding the capability of Phoenix’s proprietary recycled polyethylene terephthalate (RPET) cleaning process (referred to as | | | | | | | | | | ) in producing RPET of a purity suitable for use up to 100% recycled content in manufacture of containers for contact with all food types under Conditions of Use B through H, as described in Table 2 on our website at: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html.
We have reviewed PTI’s recycling process as well as the information obtained from surrogate testing and migration modeling, which were submitted to demonstrate the capability of the PTI’s secondary recycling process to remove potential contaminants from RPET. Based on our review of these data, we have determined that PTI’s secondary recycling process, as described in the April 15, 2008 submission, would be effective in reducing potential contaminants from the feedstock, consisting of food and non-food PET containers, to food at levels that result in a dietary concentration (DC) below 0.5 ppb, FDA's threshold of regulatory concern.
We reviewed the information on the thermal process used in the PTI’s recycling process to decontaminate the RPET. The process parameters would be determined by using a computer model ( | | | | | | | | | | | | | |) that is developed based on diffusion and other processes. The thermal process will be variable and depends on the process parameters, including the PET particle size and geometry, and the temperature and time required to ensure the suitable purity of the RPET for manufacture of food contact articles. We determined that the | | | | | | | | | | , modified as described in the submission would be applicable to decontaminate RPET (called | | | | | | | | | | with | | | | | | | | | | | | | | | | | | | | ) under the process conditions as described in the April 15, 2008 submission to the levels that would limit the migration of a contaminant into food and does not result in DC to exceed 0.5 ppb, the level that FDA would equate to negligible risk for a contaminant migrating from food packaging.
We have concluded that PTI’s secondary recycling process, as described in the subject submissions, can produce RPET that is of a purity suitable for use (up to 100% recycled content) in the manufacture of articles in contact with all food types under Conditions of Use B through H, as described in Table 2 on our website: http://www.cfsan.fda.gov/~rdb/opa-fcn3.html, provided that the feedstock consists of food and non-food PET containers, excluding industrial PET containers. The RPET should comply with the existing authorizations applied to PET, and does not impart odor or taste to food rendering it unfit for human consumption. If PTI’s recycling process is modified, new data may be needed to be evaluated.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Vanee Komolprasert, Ph.D., P.E.
Consumer Safety Officer
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition