Document 9LyNpnaDLoZevmB52eweNBemR

3/22/74 FDA/PVC CUSTOMER QUESTIONS Typical questions your customers may ask and specific responses you can make. 1. Question; How is determination made of the residual level of vinyl chloride monomer content in the PVC food contact surface ... in the extractant (food or liquid) ? Answer: Techniques for measuring presence of VCM, based on gas chromatography, are available at most commercial testing laboratories. If you do not maintain your own laboratory, we would suggest that you go to an industrial analytical laboratory, university, institute, or private laboratory in your area. 2. Question: Is there a standard test for detection of VCM that has been used in the past and will be used in the future? Answer: Our own test procedure has been applied widely over the past several years but this is not necessarily the approach the FDA will take. FDA, however, will make final determination of the procedure to be used. 3. Question: Will you work with us to check on our testing procedures and will you make your technical men available to us for advice and counsel? Answer: We will be glad to send you details of our testing procedure. Then, if you should have questions, give me a call and we will have the appropriate specialist telephone. Please do not attempt to get in touch with any of our technical centers directly. continued ... BFG23434 22984001 2- - 4. Question: Does your resin have a uniform level of VCM contamination? Answer: Not necessarily, and at this time we cannot guarantee maximum levels of VCM. 5 . Question: What experience do you have with migration of VCM from PVC pipe into an extractant such as water? Answer: During the past year we have conducted tests on water left standing in PVC pipe for periods of 2-7 years and at varying temperatures and have found no detectable VCM. 6. Question: Will you send me the results of tests you conduct like this on PVC pipe ? Answer: Although our results may not correlate with yours or be indicative of what you may find, we shall be glad to send you our findings. 7. Question: How frequently should testing be conducted? Answer: We expect the FDA to establish procedures. 8. Question: What levels of VCM can we expect in the resins you ship us? Answer: Ppm of VCM in product we sell: a. Flexible compounds Dispersion resins Virtually undetectable b. Rigid compounds EP Resins & 90 Series Resins (except 103 EP F-76) Less than 50 ppm *0 continued ... 8 BFG23435 7 -3 - c. 103EP F-76 300X6 and 430X30 202 and all Solution Resins * All Copolymers 80X and 140X Series d. Vinyl Latex Possibly greater than 50 ppm resulting in detectable concentrations in heated mixers or at hot end of the process See Bulletin L-13 Handling & Storing Latex read P.7 -- Safety Precaution. Our vinyl latexes are stripped of residual monomer to less than 0.08% 9. Question: Will you certify the level of VCM in resin you ship us? Answer: We are not in a position to certify at this time, but we have had encouraging results from our program to reduce the level of VCM present in all of our vinyl products. This program will continue. Over a period of time, our goal is to supply resins to the packaging industry and to the pipe industry that will enable our customers to meet new or revised regulations. 10. Question: As a pipe producer where can I go for help? Answer: The Plastic Pipe Institute of S.P.I. is expected to establish procedures. For their plans, get in touch with: Raymond Durazo The Society of the Plastics Industry, Inc 250 Park Avenue New York, New York 10017 212/687-2675 RBD:mls BFG23436