Document zdOYZQZMyzKGoX4ZrOmQaBRx3

November 20, 1992 Joel M. Mirsberger, Oscar Mayer Foods Corp. P.O. Box 7188 910 Mayer Ave. Madison, Wi. 53707 C.P.M. Dear Mr. Mirsberger: This letter is in response to your request for information on the FDA status of the recipe for PVC 411 which you supplied. Based on the description that you provided, the lubricant, Loxamid EBS, appears to be the limiting ingredient. The information that we have on this material indicates that 21CFR175.105 (Adhesives), 21CFR175.300 (Resinous and Polymeric Coatings) , and 21CFR177.1210 (Closures and sealing gaskets for food containers) are the only sections for which this ingredient has clearance which are applicable to PVC. Please refer to the above sections for verification. You can call me at (216) 447-7978 or Connie Dillon at (216) 447-7831 if you have any questions. Sincerely, Robert K. Hinderer, Ph.D. Director, Health, Toxicology and Product Safety | 21604001 BFG15689 '~fr\oy-&> X- PV(L+ 4-ff Pij a P-4/~cm-- fCA Sid&i. buffc J'') btMA(/7%y ...... . '~1"KXA^a^-iiX^ Q87f *J . N Q,h '101 53fl Qjutr&LjL tl*. lf\ JuJy (tool*) 1 ?> 4 - 4**, & 0 ? /- / ?- i- I11. 3-?<A<i(t<(%_&iwt) (jj s', i&yt74. /7o_f)77rtvc, n~!.2ioo fijr.toyj thn^. 1'O'z* .. Ho&n<q r.i''~ '* thp*.(j. Stc4,t*& /l*. rft*52S\ 71(0 (t :; ^ tnf-i^riu) JL t. >i '- il Aj. flj L " : fy ' ' ~tb,' #< Uc/- /OS' }7T >3>0d t A fl (J?a". /0>f TT-7^% jaaT} /nn.J-u>o' U97. I~77. l4^k\ /77 2-^70 n7.2$$ ' : ' > ^v>i. ^ ^ /A A * .A I A--- pin J- (LoPjC^xt. -ixhS >"" 'v\a'.Xv*>":\ lO> ^>v n BFG15690 10 h* o A**"*, to ! October 19, 1992 / Bruce Dovey SUBJECT: FDA STATUS OF OSCAR MAYER'S PVC 411 COMPOUND This will confirm our discussion regarding the status of PVC 411 under FDA's Indirect Food Additive regulations. We have reviewed the recipe for PVC 411. The use of PVC 411 as an indirect food additive is limited to the following uses under CFR 21: 1. 175.105 - Substances for use only as components of adhesives. 2. 175.300 - Resinous and polymeric coatings. 3. 177.1210 - Closures w/sealing gaskets for food containers. Furthermore, this compound must meet the extraction requirements as described under 21CFR 178.2650(b)(1). Connie Dillon 1019-1/jp cc: R. K. Hinderer 21604003 BFG15691 A/l/^12- November 20, 1992 Joel M. Mirsberger, Oscar Mayer Foods Corp. P.O. Box 7188 910 Mayer Ave. Madison, Wi. 53707 C.P.M. Dear Mr. Mirsberger: This letter is in response to your request for information on the FDA status of Geon 86223 TRANS PLTS 411 and Geon 86224 TRANS PLTS 413. Based on our evaluation of the recipes, the FDA clearance for these compounds is limited to 21CFR176.120 (use as an adjuvant in the manufacture of paper and paperboard products). Please call me at (216) 447-7978 or Connie Dillon at (216) 4477831 if you have any questions. Sincerely, Robert K. Hinderer, Ph.D. Director, Health, Toxicology and Product Safety 21605001 BFG15692 I :-':AOn 03E36' OF GOODRICH COHP^-NV `IFF FAG IF F E R V 1 C E T C C!... E V M A .1 N D 2 C M H F N' 1 ? 0 O G 4 13'. .INF; -3 33 -4 3 :-,ou"'"f r:v dill.cn conn if n .li -,tJ; !l; AI -il- II; -*1; j|; t! ii; -II; ii; -II; -0; }l; U ji/ u; il; ii; j!; H; jl; II- -!i- 3. [j It'- jj'. "|LV. (' ^j'. -jj. .'.j'. .jj'- .jj`. Ajj'. ,jj'. ,jj'. ; f 'ii- ; GEON VINYL TECHNICAL DOCUMENT ii jt* ii ii ii ii -ii ii ii -ii ji ii ii -ii -ji ii ji -ji -ji ii i .ji ->i .... )>: )i i>: ji ji >i ji ii R ] 033 0 L 0 N V I N T :... EECI!::,E G E 0 N Li 6 2 2 3 r R A N S F I... 12 A 1 COMHODITY NO,' 86223 000 ,B 0 H B K 1 h, 1 1 LAY EE! OANED ON A a PIC A T 10 L ' GO' 10 0Epr' 3796 ISSUE' FFECTIVE DATE' 01/01/92 DEL FIE' FLAG : NO CM PR ' 292 INGREDIENTS E.7 :...0C PERCENT 'h / ^ ,..; 1 'nL>M()yiy}oy. Wj(17. /900 , PEC 1; p r f; gravity Tv' pE SAMPLEISSUED' ii H K K ! IN L A FFPi U V A L. ' jl/ 4 3 O ij T ii' F I) 3: ji ji ftfQO 2. fCt'F HARDNESS COlY/l ___ &L-.. ----- BFG15693 '00 ; R' RON ; BL G 0 Uli K .i. G!"! I..- U ii F1 A N Y ri E l 2 h G L SERIvIlE : C!... 2 V M A I M 0 C C U H E N T 1 7 O 0 0 5' 1 51 i... IN E S URIEL TO: 1/ Ii... Q n , 7 l; \i; if- 'll; !l- O'- ''ll; >!> -}l; II; -II; Ii; ;U; ) ii;. 4y. 4,;. 4,;. CONNIE N .if. -; 4,- .)!; -ju> -ji; ft- a- GEON VINYL. RE LITE 1C .. .)i;. 4.. :n;. v. 4.. :a;. ;u;. 4.;. ,a\ .a;. . TEC HNLLCAL DQCUHEN" i 1 LI 1 C) 3360 Cv E D N V i N Y S... RECIPE 1 1 /' 1 i' / L 1 ; : y 4 A GEON 06224 TRaNS l::'LC2 41 3 COMMODITY NO,- 86224 00a 41 NBC NEC: 13c LAB REF: BANED ON: APPL ICAP I On 8 L..OC : 10 DEPT: EFFECTIVE DATE: UELETE FLAG: CMPR 96 INCUEOi / A1 / 9 2 NO 292 PAN ! 1 : n g LED I ENT 2 A9 R4AR 41.. 67976 , 1 4 885C 4885 9,4 > 931 91 2 943 000498 ?1088? 7A8552 00L.0 08 110 X 458 EG JAYELEX 260 THERMO:.. LILTE 813 STEARCNE S E 2 L 0 C PERCENT 110 21 0 31 8 41 0 10 58,651 41,056 , 1 4? .. 1 4 7 TOTAL 100,000 OPEC IF GRAVITYTYPE SAMPLE : ISSUED . A !-:K E i I NO- A PI"'RU V AL : 1,2 HARDNESS COLOR 21605003 BFG15694 OSCAR MAYER FOODS CORPORATION November 3, 1992 Mr. Bruce Dovey BF Goodrich 6100 Oak Tree Boulevard Cleveland. OH 44131 Dear Bruce: A regulation became effective July 17, 1984 stating that all plants under USDA inspection must obtain written guarantees from suppliers stating tat each material used in packaging meat or poultry products in the plant compiles with federal food laws and regulations. The guarantee will be accepted by USDA inspectors to establish that the material can be legally used for packaging meat and poultry products. Responsibility for providing guarantees to meat and poultry plants rests with the firm whose trade or firm name appears on the material as it is marketed to the plant. Meat and poultry plants must maintain a file containing guarantees for all packaging materials in the plant. This file must be open to USDA officials at all times. All packaging materials in the plant must be traceable to a guarantee in the file. USDA inspectors, however, retain the authority to refuse a specific material which they determine may cause adulteration of products. The guarantee must state that all packaging materials and components of such which are intended to come in direct contact with a meat or poultry product comply with the Federal Food, Drug and Cosmetic Act and all applicable food additive regulations. Additionally, the guarantee must show: 1. Brand name or code designation of supply and components. 2. Name of Supplier 1 3. Specific conditions for use of material including temperature. If there are no conditions for use, please indicate same 4. Signature and title of corporate official of supplier. 5. Guarantee should be continuing to cover all shipments, however a new guarantee must be supplied upon change in supply. Further, it is requested that one(1) supply item be declared per form. Components for a supply are to be incorporated. Accordingly, I am requesting that you provide a separate letter ttached format covering each item that you sell to any Oscar Mayer Foods Corporation location. Please send a copy of your letter directly to each of those plants' Purchasing Manager and one copy to me. It is essential that you cover aM packaging materials sold to Oscar Mayer Foods Corporation or its subsidiaries. -tro:jS09T 3 J. M. Mirsberger Senior Purchasing Agent Attachment PUR#1-24.WP USA 999 )S( AK MAN |KIOOtJM(lk!'UK\:U)\ A K K AI I < ,1 \l KAI M)OI)S. IN( . SUBSIDIARY |>(). HO\ "Ki.'S, MADIst )\ \\ | , : T UN I1I()\| . (>()M J-11 - ? ' II, H 11 \: BFG15695 ! JOEL M. MIRSBERGER, C.P.M. SENIOR PURCHASING AGENT OSCAR MAYER POODS CORPORATION P O. BOX 7188 910 MAYER AVENUE MADISON. W153707 (608) 241*6732 FAX (608) 241 -6734 BFG15696 rv ' ! 1'Rfi/Ub fin in jfCtf.. Avr ,Ui.a ijovsr. 0> i p( ^i) r%m(i7%) </ r 6 22 V 7#^: f J) A QJo-6^-**^t a?>U'~ vV. V'^ 4/z ^tsT ro*r IIS,Zoo nc. no it nn, tifo&j . /77, *k m m / 72. 37<2tf (m)A 2-^ SSA..(UJL-11- yi so ($. )(*) _______ /77 /? `TO <rujil. Jf% o XL / 7(>. (lO^r} (to.'i^o) O 77. / 2 w&j6c c?/ Jvf^ i nyji-oQ Jr(q) ( 0,3 s PjC- fr&)sSrP**^ 1609005 BFG15697