No Objection Letter for Recycled Plastics #99
April 27, 2006
Packaging Development Resources
333 Bayside Drive
Newport Beach, California 92660
Dear Mr. Preston:
This responds to your e-mail submissions of March 30 and April 20, 2006, requesting a letter of "non-objection" (NOL) for the use of recycled polystyrene resin in the manufacture of food-contact articles. You state in your e-mail that the Packaging Development Resources (PDR) recycling process, except for minor differences, is the same process as that established by Nova Chemical in 1993 and most recently by Evergreen Partnering Group (EPG) in 2001/2002, for which FDA has issued NOLs. You state that the same equipment for the washing, grinding and drying steps in the EPG process will be utilized and that one of two extrusion options will be used, both of which utilize the same technology employed by EPG in their processes. You state that the minor differences include a different waste water treatment subsequent to the process and that the extrusion equipment may be procured from a different manufacturer.
We previously concluded in our letter to EPG, dated August 28, 2001, that post-consumer recycled (PCR) polystyrene resin produced by their company's process would be acceptable for use in making trays, plates, cutlery, cups, containers, and lids for use in fast-food and similar restaurants provided that the PCR resin was previously used for food-contact applications and there is strict source control. You indicate that PDR's recycling process will also use strict source control in that only articles previously used exclusively in contact with food, manufactured with "food-grade" polystyrene, will be used to manufacture the PCR polystyrene resin. You state that initially the polystyrene source material will be obtained from school cafeterias, and that later other material food-service cafeterias will be evaluated for the source material based on your ability to design systems to ensure that the product is not contaminated with other items beyond the food it is designed to hold/carry. You also indicate that the PCR material will be marketed for similar uses as those of EPG's PCR material: food service foam and rigid polystyrene holding/carrying vessels, including trays, plates, cutlery, cups, containers and lids, in food service outlets where the exposure to food is limited in time and application. As was the case with EPG's recycling process, PDR's process will involve blending the PCR polystyrene resin with virgin food-grade polystyrene.
We note that it is the responsibility of PDR to assure that both the recycled polymer and the virgin polymer used in the blend meet the specifications and other requirements of 21 CFR 177.1640: Polystyrene and rubber-modified polystyrene, that the use of any adjuvants in the process is authorized under 21 CFR, and that the final product is of a purity suitable for the intended use, i.e., does not contain microbiological or other contaminants that may represent a safety problem in the intended use of the product.
We have no reason, at this time, to change the opinion expressed in our August 28, 2001 letter to EPG and do not regard the differences you describe with their process as ones that imply a significantly different process. Therefore, we consider that the PCR polystyrene resin that is collected, sorted, and processed in the manner you have described will be suitable for the uses described above.
If you have any further questions concerning this matter, please do not hesitate to contact us.
Consumer Safety Officer
Division of Food Contact Notifications, HFS-275
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition