Document kmDx1EaVmOOnJ4OdkQ3pd78K0
BFGoodrieh
Jl
The BFGoodrieh Company Specialty Polymers & Chemicals Division 9911 Brecksville Road Cleveland, Ohio 44141-3247 216-447-5000
October 25, 1993
Specialty Polymers & Chemicals Division
Mr, Jim R. Garrett, Manager PMI Food Equipment Group 701 Ridge Avenue Troy, OH 45374
SUBJECT: Fiberloc 803GR10GRY 206/235/251 FDA Status
Dear Jim:
A review of the current recipes for the above Fiberloc Compounds indicates that the <^hre'eN compounds do not have any clearance for indirect food additive applications under the current requirements of the FDA and do not have any USDA clearance. Each of the three compounds contain two ingredients which currently do not have any FDA clearance according to the supplier.
The equipment manufacturer is responsible for obtaining USDA approval for the specific application. The Geon Company can assist you in obtaining the desired approval by submitting to the USDA the confidential compositions of the three Fiberloc compounds. Similar information also would need to be provided from suppliers of any other raw materials that are used. Obviously, any change in formulation would require re-approval.
If you have any questions, do not hesitate to give me a call.
Sincerely,
BFGOODRICH COMPANY
connxe jn . union Regulatory & Data Systems Specialist
CND/amc
21728001
BFG16293
BFGoodrich
The BFGoodrich Company Specialty Polymers & Chemicals Division 9911 Brecksville Road Cleveland. Ohio 44141-3247 216-447-5000
October 25, 1993
Specialty Polymers & Chemicals Division
Mr. Jim R. Garrett, Manager PMI Food Equipment Group 701 Ridge Avenue Troy, OH 45374
SUBJECT: Fiberloc 803GR10GRY 206/235/251 FDA Status
Dear Jim:
A review of the current recipes for the above Fiberloc Compounds indicates that the three compounds do not have any clearance for indirect food additive applications under the current requirements of the FDA and do not have any USDA clearance. Each of the three compounds contain two ingredients which currently do not have any FDA clearance according to the supplier.
The equipment manufacturer is responsible for obtaining USDA approval for the specific application. The Geon Company can assist you in obtaining the desired approval by submitting to the USDA the confidential compositions of the three Fiberloc compounds. Similar information also would need to be provided from suppliers of any other raw materials that are used. Obviously, any change in formulation would require re-approval.
If you have any questions, do not hesitate to give me a call.
Sincerely,
BFGOODRICH COMPANY
Connie N. Dillon Regulatory & Data. : Systems Specialist
CND/amc
Z17Z800Z
bcc: Mike Balasko - ALTC - 8/221-1671 Tom Ulliman - Geon - 502/426-7585
BFG16294
. 10/18/93
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16:38 -JO
216 933 1671 r no It fill
MOLDING
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PMI Food Equipment Group
James R. Gafiett, Manager Product Development Engineering WeighAVrap Equipment Division
World Headquarters
70! Ridge Ave. Troy, Ohio 45374
513 332-3058 FAX 513-332-3007
TO: Don Milier^eo^Comgany FROM: Jim G SUBJECT: Fibrefep 803GR1
Dear Don,
October 14,1993
10 J fir, hri UJ]*dt
PMI/Hobart and Geon seem to have a problem in communications which I am certain that you can rectify in short order. We at PMI/Hobart, Weigh/Wrap Equipment Division, have been purchasing the subject material from Goodrich/Geon for about five years to use as cabinetry material for our scales. We purchase two colors; light and dark gray. PMI/Hobart has been under the assumption that the material, in its molded state, is USDA approved for incidental food contact. PMI/Hobart, Weigh/Wrap Division, is now in the process of developing two new products which also will have cabinetry made of the Geon material and I felt that it would be proper if we had documentation which stated what we have been assuming all these years.
/
Mr. Tom Dean of our company contacted Geon several weeks ago to inquire if Geon
had documentation to support our belief and the answer was *'We do not have
documentation but we think it is approved". Tom inquired if the necessary tests r"
could be run to acquire the approval and the answer was yes.
,
Mr. Walter Rym visited our facility last week to discuss this situation, met with
f
*
Tom and me and it was stated very succinctly to Walter that we needed to know the j /
answer on the gray material post haste. Walter has just now talked to Tom and said / j
that they would start testing on the "cream color" material. That is, not nor was it
ever, the plan. The cream color is irrelevant: it will be phased out in the near future
for the gray material.
J. iu
r
We need the gray Fibreloc tested and need it yesterday and we are more than willing to work with you in this effort. Please have someone within Geon organize this test and have them contact Mr. Tom Dean for any assistance they may require. We are loosing valuable time in our development schedule and the status of the Geon material needs to be established.
Thanking you in advance
BFG16295
10/19/93 16:36
216 933 1671
MOLDING
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MOLDING
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C103D326
BFGOODRICH GEON VINYL DIVISION
USERID: N50CND1A
C103F326 GEON PROD
RECIPE INQUIRY
PTERMID: PV120085
PRODUCT NBR: 87333 000 2012 87333BLKPD 201 LOC: 10 DEPT: 5772 ISSUE: 007
SBC: 13PM EFFECTIVE DATE: 930927
INTERMEDIATE RM NBR: 961000412
TOTAL LBS RM:
100.000000 LBS PRODUCT:
100.000000 RECIPE TYPE: 4
PAGE 1 OF 1
SEQ RAW MATL DESCRIPTION
QUANTITY LC C103D326
BFGO
ODRICH GEON VINYL DIVISION
USERID: N50CND1A
C103F326 GEON PROD
RECIPE INQUIRY
PTERMID: PV120085
PRODUCT NBR: 87333 000 2012 87333BLKPD 201 LOC: 10 DEPT: 5772 ISSUE: 007
SBC: 13PM EFFECTIVE DATE: 930927
INTERMEDIATE RM NBR: 961000412
TOTAL LBS RM:
100.000000 LBS PRODUCT:
100.000000 RECIPE TYPE: 4
PAGE 1 OF 1
SEQ RAW MATL DESCRIPTION
QUANTITY LC PERCENT COMMENTS
001 961-001010 110 X 477
68.000000
68.0000
002 925-709635 SUPER-PFLEX 200
31.000000
31.0000
003 922-710008 BLACK MONARCH 7
1.000000
1.0000
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NEXT RESPONSE:
NEXT KEY:
DC900016 RECIPE INQUIRY OK
PF5-PROP PF6-RMKS PF9-SAFE PF10-INST
C103D326
BFGOODRICH GEON VINYL DIVISION
USERID: N50CND1A
C103F326 GEON PROD
RECIPE INQUIRY
PTERMID: PV120085
PRODUCT NBR: 87333 00E 4055 87333 BL MB4055 LOC: 10 DEPT: 5772 ISSUE: 007 EA
SBC: 13PM EFFECTIVE DATE: 931001
INTERMEDIATE RM NBR: 961000598
TOTAL LBS RM:
100.000000 LBS PRODUCT:
100.000000 RECIPE TYPE: 2
PAGE 1 OF 1
SEQ RAW MATL DESCRIPTION
QUANTITY LC PERCENT COMMENTS
001 961-000452 110 X 377
65.000000
65.0000
002 925-709635 SUPER-PFLEX 200 30.000000
30.0000
003 921-711186 BLUE BCS
5.000000
5.0000
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NEXT KEY: PF5-PROP PF6-RMKS PF9-SAFE PF10-INST
21728006
BFG16298
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BFGOODRICH GEON VINYL DIVISION
USERID: N50CND1A
,326 GEON PROD
RECIPE INQUIRY
PTERMID: PV120085
PRODUCT NBR: 87333 000 2012 87333BLKPD 201 LOC: 10 DEPT: 5772 ISSUE: 007
.BC: 13PM EFFECTIVE DATE: 930927
INTERMEDIATE RM NBR: 961000412
'OTAL LBS RM:
100.000000 LBS PRODUCT:
100.000000 RECIPE TYPE: 4
SEQ RAW MATL DESCRIPTION
QUANTITY LC C103D326
PAGE 1 OF 1 BFGO
JRICH GEON VINYL DIVISION
USERID: N50CND1A
:103F326 GEON PROD
RECIPE INQUIRY
PTERMID: PV120085
PRODUCT NBR: 87333 000 2012 87333BLKPD 201 LOC: 10 DEPT: 5772 ISSUE: 007
C: 13PM EFFECTIVE DATE: 930927
INTERMEDIATE RM NBR: 961000412
?OTAL LBS RM:
100.000000 LBS PRODUCT:
100.000000 RECIPE TYPE: 4
PAGE 1 OF 1
SEQ RAW MATL DESCRIPTION
QUANTITY LC PERCENT COMMENTS
001 961-001010 110 X 477
68.000000
68.0000
002 925-709635 SUPER-PFLEX 200
31.000000
31.0000
003 922-710008 BLACK MONARCH 7
1.000000
1.0000
- /<?/<?; /W Plvtu*-
lOW/bS: It'0 oof:
\
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m.l'/oQ- /77 ZLooO-S'0%)
EXT RESPONSE:
NEXT KEY:
900016 RECIPE INQUIRY OK
PF5-PROP PF6-RMKS PF9-SAFE PF10-INST
103D326
BFGOODRICH GEON VINYL DIVISION
USERID: N50CND1A
103F326 GEON PROD
RECIPE INQUIRY
PTERMID: PV120085
PRODUCT NBR: 87333 00E 4055 87333 BL MB4055 LOC: 10 DEPT: 5772 ISSUE: 007 EA
BC: 13PM EFFECTIVE DATE: 931001
INTERMEDIATE RM NBR: 961000598
OTAL LBS RM:
100.000000 LBS PRODUCT:
100.000000 RECIPE TYPE: 2
SEQ RAW MATL DESCRIPTION
QUANTITY LC
PAGE 1 OF 1 PERCENT COMMENTS
001 961-000452 110 X 377
65.000000
65.0000
002 925-709635 SUPER-PFLEX 200
30.000000
30.0000
003 921-711186 BLUE BCS
5.000000
5.0000
- A7c Au^
- 101 Wi t( ( 9 (a*
ipf.fd/ -y /rt. =-7 /-75~.3ooyir.32*f7j'
EXT RESPONSE: :900016 RECIPE INQUIRY OK
NEXT KEY: PF5-PROP PF6-RMKS PF9-SAFE PF10-INST
CVvrvO-y / TO*
BFG16300
10/13/03 16:14
216 933 1671
MOLDING
001
The Geon Company
Avon Lake Technical Center Moore & Walker Roads P.O. Box 122 Avon Lake, Ohio 44012
Molding & Automotive R&D Bldg 428, Dept 5054
To: Connie Dillon
Company; BFGoodrich Phone: 5182
Fax: 5710
From: Michael Balasko
Phone: 1689 Fax: 1671
Oate: 10/13/93 Pages including this
cover page: 2
Comments: Connie...Here is the recipe for Fibertoc 87803-
010-0204. Please determine if this material is USDA approvable
for use as a housing for a supermarket weigh scafe....Mike
f\c \Q y jT ? .
BFG16301
10/13/93 16:16
216 963 1671
MOLDING
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BFG16302
10/19/93 10:25
210 933 1671
MOLDING
12)001
The Geon Company
Avon Lake Technical Center Moore & Walker Roads
P.O. Box 122 Avon Lake, Ohio 44012
Molding & Automotive R&D Bldg 428, Dept. 5054
To:
Company: Phone: Fax:
Connie Dillon
BRDC 5182 5710
From:
Phone: Fax:
Michael Balasko
Senior R&D Engineer 1689 1671
Date: 10/19/93 Pages including this
cover page: 2
Comments: Connie....Plea$e determine the FDA acceptability of the attached experimental recipe xl650-590-5201. The target application is a flexible PVC grommet or tubing for a refrigerator water dispenser....Mike
T IA Q 7 /T 2
BFG16303
10/19/93 10:26
216 933 1 671
MOLDING
RECIPE FOR FDA ACCEPTABILITY
LAB BOQK NUMBER
165 59 52 1
RAW MATERIAL CODE 961-001008 932-710541 935-O0P031 919-00S081 943-00L0O3 925-00F005 943-710339 943-00L002 924-709916 921-00B272 921-00B273 961-000543
DESCRIPTION 110x471 Drapex 334F Epoxy Soya
Zinc Stearate ACF Calcium Stearate Calcium Carbonate Glycolube 825
Stearic Acid Ttoxide RFC-6 Blue 5006 Violet 5012
85435-000-6052
TOTAL
PHR 100 101 10
0.2 0.1 75 0.1 0.2 4.5 0.016 0.06 0.074
wr% 34.335 34.678 3.433
0.069 0.034 25.751 0.034 0.069 1.545
0.005 0021 0.025
291.25 100.000
002
21728012
BFG16304
