1. Recycled Plastics in Contact with Food: FDA’s Policy Kristina E. Paquette, Ph.D. U.S. FDA Center for Food Safety and Applied Nutrition Office of Premarket Approval California’s Rigid Plastic Packaging Container Law: How Does It Impact You? San Diego, CA May 16, 2000

2. Legal Considerations u Food, Drug, and Cosmetic Act Section 409 u 21 CFR 177 Polymers u §174 Indirect Food Additives: General What is the purity suitable for the intended use? §174.5(a)(2)

3. “Points to Consider” Guidance for Use of Recycled Plastics u Sourcing of post-consumer resin u Recycling process u Use of an effective barrier u Surrogate contaminant testing u “Points to Consider” available at: http://www.cfsan.fda.gov/~dms/opa-cg3b.html

4. Sourcing of Post-Consumer Resin (PCR) PCR must comply with 21 CFR 177 Polymers u PCR from previous food-contact uses u bottle-bill collection u curbside recycling collection with appropriate sorting u PCR from previous non-food uses

5. Recycling Process u Primary processing In-house plant trim u Secondary or physical processing u Grinding and washing u Melting and reforming u Tertiary or chemical processing u Depolymerization u Purification of regenerated chemicals u Cannot use unregulated substances

6. Use of an Effective Barrier u Effective barrier between recycled material and food = Not a food-contact situation for recycled layer u Effective barriers: u Glass u Metal, metal foils u  1-mil thick PET at room temp and below u Any substance that limits migration of outer-layer components to 0.5 ppb dietary concentration

7. Surrogate Contaminant Testing u Contaminate (“challenge”) virgin resin with surrogate cocktail u Run challenged resin through recycling process u Measure amount of surrogates remaining in resin after recycling u Dietary concentration of each surrogate must not exceed 0.5 ppb u Assume 100% migration u Migration tests or modeling

8. Recommended Surrogates u Volatile polar Chloroform u Non-volatile polar Benzophenone or Lindane u Organometallic Copper(II) 2-ethylhexanoate u Volatile non-polar Toluene u Non-volatile non-polar Tetracosane or Methyl stearate

9. Maximum Surrogate Level Allowed in Finished Recycled Resin DC  10 g food/in 2 C R = ------------------------- R MS  CF C R = surrogate conc. in finished resin DC = allowed dietary concentration R MS = mass-to-surface area ratio of resin (g/in 2 ) CF = consumption factor for polymer u Assumes 100% migration and 100% recycled content

10. Example Calculation for PET u DC = 0.5  g/kg (ppb) u R MS = 0.46 g/in 2 (density = 1.4 g/cm 3, thickness = 20 mils) u CF = 0.05 for polyesters u  C R = 215  g/kg (ppb)

11. Food vs. Non-Food Containers u PCR must comply with 21 CFR 177 Polymers u “Points to Consider” cover post-consumer contamination of food containers u Expose bottles or flake to surrogate cocktail for 2 weeks at 40 o C u Do these conditions cover containers intended for non-food applications?

12. Case Study: Non-Food PET u All rigid PET containers comply with 21 CFR 177.1630 or 177.1315 u Starting levels of surrogate contaminants in challenged PET flake can be no less than modeled sorption levels Assumptions used in modeling: u 1-L PET bottles u 10% w/w surrogate solutions in water u 365 days at 25 o C

13. Minimum Surrogate Levels in Challenged PET Flake to Allow Use of Non-Food PET Chloroform4860 mg/kg Toluene1000 mg/kg Lindane 750 mg/kg Tetracosane 154 mg/kg Benzophenone 49 mg/kg Copper(II) 49 mg/kg

14. Administrative u Currently, FDA issues opinion letters to recyclers who submit surrogate testing data u For a list of all plastics recycling opinion letters issued by FDA, see http://www.cfsan.fda.gov/~dms/opa-recy.html u FDA is developing a regulation for recycled plastics that will codify the surrogate testing process

15. Opinion Letter Statistics as of December 1, 1999 u PET36 u Secondary26 u Tertiary10 u HDPE 7 u PS12 u PE or PP 2 u PEN (tertiary) 1 u Other 1 Total59

16. Summary u Legal Considerations u “Points to Consider” Guidance u Sourcing of PCR u Recycling Process u Effective Barrier u Surrogate Testing u Use of Non-Food PCR u Administrative u Opinion letters u Regulation being developed

17. Useful References u Kuznesof, P.M., and M.C. VanDerveer, “Recycled Plastics for Food- Contact Applications,” in Plastics, Rubber, and Paper Recycling, Ch. 32, ACS Symposium Series 609, Washington: American Chemical Society, 1995, pp. 389-403. u Begley, T.H., and H.C. Hollifield, “Food Packaging Made from Recycled Polymers,” in Plastics, Rubber, and Paper Recycling, Ch. 36, ACS Symposium Series 609, Washington: American Chemical Society, 1995, pp. 445-457. u Komolprasert, V. and A. Lawson, “Residual Contaminants in Recycled Poly(ethylene terephthalate),” in Plastics, Rubber, and Paper Recycling, Ch. 35, ACS Symposium Series 609, Washington: American Chemical Society, 1995, pp. 435-444.