Document Gz5vakOERdkxaQ6bV0dobLVrv

Mr. D. C. K17 Bakclite Company 2 East AA; lat Street ew York Mr. A. J. Pragonette Mr. 8. P. Robertson May 0, 1956 Colorant - Rigid Vinyl Sheeting Sear Mr. Kayi In regard to the colorant External SIC Yellow No. 3* which was Included in the formulation you submitted to me* X had an opportunity to discuss this yesterday with Sr. A. J. Lehman* Chief Pharmacologist of the Food and Drug Administration* Be informed me that he did not think this colorant would be acceptable. It is an external oolorant certified for "externally applied drugs and cosmetics*" which means drugs and cosmetics that are applied only to external parte ef the body and not to the lips or any body surface covered by mucous membrane. Colorants used in food packaging materials should be ones acceptable for internal consumption unless it can be adequately demonstrated that none of the eelorant would migrate from the material In axtractloa studies. Because of the solubility of the yellow referred to above* It la expected that it would be extracted from the vinyl sheeting. An endeavor should bo made to secure e pigment for which the manufacturer can supply information aa to Its acceptability as a colorant in food packaging materials ouch aa vinyls. It may be quite difficult to find an ac ceptable yellow. Very truly yeurs* MEDICAL Kttmtm n ucc 063701 VCC*D Ta (Nam.) Company lacoHoa Copy to FOR INTERNAL CUKKtWUNULNlb BAKELITE COMPANY --------------------- --as------------------------ 30 EAST 42nd STREET, NEW YORK 17, NEW YORK Dr. T. W. Hale Do*. April 2U, 1956 Industrial Medical & Toxicology Dept 300 Madison Avenue Originating Dnpt. New Product Engineering New York 17 * New York Answering Ittimr dot* Mr. A. J. Dragonette Mr. H. F. Robertson Subject 'i*** __ . uo Information recently given to us by Mr. F. W. Rose* the attorney for International Latex Company, makes it iterative that we get additional and more specific approvals on our food packaging grade rigid vinyl sheet and cast vinyl film. This additional approval is necessary to our continued progress with Latex in their program of packaging cut and dressed poultry. A copy of my letter to Mr. A. J. Dragonette is attached for your reference which explains Mr. Rose's directions to us and views regarding the necessary approvals. To assist you in preparing your request for the specific approvals which appear necessary to satisfy the request of International Latex, there are attached proposed drafts of letters to the three government agencies involved giving complete formulation data and compound designation. Mr. Rose particularly requested that we include the colorant In the formulation since in his opinion it can be just as important as the stabiliser. The letter to Mr. Mehurin will be for general use in our promotion of the packaging grade cast film, as you have already requested his approval of our rigid calendered sheeting VCAA 3ltOO in your letter of April 16 to Mr. Mehurin. r<f. D. C. Kay DCKiEE Enc. RECEIVED ^PR * ; 1956 INDUSTRIAL MEDICAL & TOXICOLOGY DEPARTMENT ucc 063702 Hr. A. J. Dragonette Bakelite Company -j?r 4 Kev York 17, New York ;C. Hr. H. F. Robertson April 11, 19$6 New Product Engineering Government Approvals on Packaging Grade Vinyl A visit to International Latex on Friday, April 6 by Bill Corbet and no pointed up the red for additional approvals from government agencies if our packaging grade rigid vinyl and cest film is to be considered by International Latex for packaging chickens. ,Kr. 7 V. Rose, attorney for Latex, has quite thoroughly investi- gated the approvals needed in putting packaged chicken on the market in a container such aa Latex contemplates using. His investigation included a talk with one of the five assistant commissioners of ths F.D.A. Kr. Rose found that the final approval In poultry packaging must com from Dr. Roy S. Villie, Chief of Poultry Inspection Branch, Poultry Division, Agricultural Marketing Service, Department of Agriculture, Beltsville, Maryland. Dr. Reman 3. Hiller is Director of ths Poultry Division. Dr. Frank Raima ean act for Dr. Willie in Dr. Willie's absence. Kr. Rose stated that approval by the Heat Inspection Branch is not even relevant when It oonwa to packaging poultry. Before International Latex ean proceed in developing e suitable poultry package, Kr. Rose Insists on being able to write directly to the Poultry Inspection Branch to secure approval on a definite compound desig nation, sudi as VCAA 32)00 Yellow $23. After such an approval Is received from Dr. Willie, Latex can proceed on their own in getting the necessary approval on the particular physical form of the proposed package. This latter approval will Involve a test shipment of chickens in ths proposed package undar the careful scrutiny of ths Poultry Inspection Branch. Then, god only then, will International Latex be free to sell their package. To enable International Latex to get cn approval on the compound i frOi Dr. Villie of the Poultry Inspection Branch, we should write to at t r/ least Dr. Lehman of the F.D.A; and Dr. Willis of the Poultry Inspection Branch Vv *-*' giving them the formulation on VCAA 3h00 Tallow 523 and VQAJL JtiQO Tallow 52L ucc 063703 Ft completeness, we should also give this Information to Kr# Xehurln f the Keat Inspection Branch* Then when International Latex -- Or any other prospaot -- writes to Dr. Willie the compound designation will aerve aa e reference number by which approval can be given by Dr* Willie to an inquirer without revealing the formulation* The above approach would, of course. Include our cast film VBAB 9023 Natural which we are suggesting as a suitable cover for the chicken package* For example* - Hr. F* W* Rose of Latex proposed to write to Dr* Willie with a request such ast "Will Bakelite rigid vinyl compound 7CIA 3UOO Tallow $23 and "Krene" cast film VBAB 9023 Natural be suitable com pounds from which to for# a package for ehipplng cut and dressed poultry?" If Dr. Willie has on file a letter from us tying in these compounds with their Ingredients, he may be able to answer lirr.ediatelyi "Bakelite rigid vinyl conpound VCAA 3^00 Telloir $23 and "Krene" cast film VBAB 9023 Natural are acceptable for use in federally inspected poultry packaging houses provided the physical form of the package is suitable*" If Dr. Willie is not familiar with the ingredients of the compounds, he can readily contact Dr* Lehman who would also have a letter in his files tying in formulation with compound number* I feel that Kr* F. V* Roes*a request la reasonable end will involve little effort on our part now that we have already presented the information on the magnesium epcocysteerate stabiliser to both Letaan and Kehurin* Photostats of letters from the 7*D*A, Keat Inspection Branch, and tie Poultry Inspection Branch which 0.1,`d our compounds by designation, rather than by naming the ingredients wuld be very helpful in talking with prospects'* All we have now are letters from Dr* Lehnan and Dr* Kehurin whieh name the stabiliser as being acceptable. Ve do not wish to tell prospects what stabiliser we are using end the prospect would undoubtedly feel wore secure if he could write directly to the government agencies Involved and get a letter of approval far hie own protection* SOKlSE ucc 063704 Dr. A. J. Lehman Chief, Division of Pharmacology Food and Drug Administration Department of Health, Education and Welfare Washington, D. C. Dear Dr. Lehman: Bakelite Company plans to promote the use of a Bakelite rigid vinyl sheet, VCAA 3U00 Yellow $23 and Yellow $2U, and a "Krona" cast vinyl film, VBAB 9023 Natural, for packaging as wide a range of food products as possible. The formulations of these compounds are: VCAA 3U00 Yellow $23 VCAA 3U00 Yellow $2U Ingredient Percentage VYNS vinyl resin (90/10 vinyl chloride/ vinyl acetate ratio) Magnesium epoxystearate (prepared from 0-60) Zinc stearate External D & C Yellow No. 3 Lake (K7150) (H. Kohnstamm Co. N.Y.C.) Titanium dioxide 97*3 (minus colorant) 2.0 - 3.0 .$20- 1.00 .25 - .50 VBAB 9023 Natural VYNW vinyl resin (95/5 vinyl chloride/ vinyl acetate ratio) D0P G-60 (Rohm & Haas) Acrawax C Durocer vax 73.5 2li.O 2.0 .17 100.00 % ucc 063705 Dr* A. J. Lehman Page 2 For previous correspondence on this subject refer to my letters of______________ ____ and your answering letters ________ _____ If you have no objection to the use of these formulations in packaging the various food products under your control, would you please send us a letter giving your opinion and mentioning the compounds by product designation only rather than by f ormulation. Very truly yours. UCC 063706 Mr* R. M. Mehurin Chief) Laboratory Section Meat Inspection Branch Agricultural Research Service C. S. Department of Agriculture Washington 2f>, D. C. Dear Mr. Mehurin: Bakalite Company plans to promote the use of "Krone" cast vinyl film, VBAB 9023 Natural, for packaging red meat and meat products. The formulation is: VBAB 9023 Natural Ingredient Percentage VTNW vinyl resin (95/5 vinyl chloride/ vinyl acetate ratio) DOP G~60 (Rohm & Haas) Acrawax C Durocer wax 73*5 2U.0 2.0 .17 *33 100.00 % If you hare no objection to the use of -this formulation in packaging red meat and other food products under your supervision, would you please send us a letter giving your opinion and mentioning the product by confound designation rather than by formulation. Letters similar to this are also being written to Dr. A. J. Lehman of the F.D.A. and Dr. Roy E. Willie of the Poultry Inspection Branch for their opinions on their respective products. Very truly yours. UCC 063707 Dr. Roy E. Willie Chief* Poultry Inspection Branch Poultry Division Agricultural Marketing Service Department of Agriculture BeItsvilla, Maryland Dear Dr. Willie: Bakelite Company plans to promote the use of a Bakelite rigid vinyl sheet, VCAA 3U00 Yellow 523 and Yellow and a "Krone" cast vinyl film, VBAB 9023 Natural, for packaging poultry. The formulations are: VCAA 3U00 Yellow 523 VCAA 3U00 Yellow 521; Ingredient Percentage VYNS vinyl resin (90/10 vinyl chloride/ vinyl acetate ratio) Magnesium epoxystearate (prepared from G-60) Zinc stearate External D & C Yellow No. 3 Lake (K7150) (H. Kohnstamm Co. N.Y.C.) Titanium dioxide . T7~ ^ '7(J 97.3 (minus colorant) 2.0 - 3.0 .2 .50 - 1.00 .25 - .50 VBAB 9023 Natural VYNW vinyl resin (95/5 vinyl chloride/ vinyl acetate ratio) DOP G-6o (Rohm & Haas) Acrawax C Durocer wax 73.5 2U.0 2.0 .17 .3? UCC 063708 Dr. Roy E. WiUie Page Z If you have no objection to the use of these formulations in packaging poultry and other food products under your supervision, wuld you please send us a letter giving your opinion and mentioning the compounds by product designation rather than by formulation. Letters similar to this are also being written to Dr. A. J. Lehman of the F.D.A. and Mr. R. M. Mahurin of the Meat Inspection Branch for their opinion on their respective products. Very truly yours. UCC 063709