Document YjbwEpZErZgG0b69oM83DrOEk
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June 21, 1991
Dave Polenda
SUBJECT: GEON 121X10/FDA 20CFR 177.2600
Recently you asked whether Geon 121X10 was acceptable under 177.2600 and sent me a copy of Wally Bachtel's letter dated 10/16/86. In order to resolve some of the issues we discussed, called Leo Borodinsky at Keller & Heckman for guidance.
I
As you know, PVC is prior sanctioned and also is specifically listed under a number of sections (see RKH letter 5/13/91, attached). Clearance for PVC resin falls under the "Basic Resin Doctrine" which allows the use of those things needed to manufacture the resin as long as Good Manufacturing Practices
(GMP's) are followed. In evaluating the clearance of the resin, one must consider the following:
1) What is the intended use of the ingredient? Is its prime function to accomplish the reaction, or is it primarily intended to provide a physical property to the resin (i.e., plasticization).
2) What is the toxicity of the ingredient? Is there an unusual or special hazard/concern?
3) How much is present in the recipe? As a rule of thumb, 0.5 to 1% is a gray area. Ingredient >1% must have specific clearances and are bound by the limitations of the relevant sections. Those ingredients used at <0.5% are acceptable unless they are unusually toxic.
Based on our discussions, the recipe that Wally reviewed (10/16/86) contained 0.25% di-(C7 and C9 Alkyl) adipate. Although some might argue that Wally's opinion is somewhat conservative, I believe that it was reasonable considering concerns about plasticizers.
With the above information in mind, your present goal of producing a Geon 121X10 type resin which meets 177.2600 can be achieved by either, 1) reducing the level of the di-(C7 and C9 Alkyl) adipate to <0.1% as long as its primary function is to facilitate the reaction, or, 2) changing to DOP (not to exceed 30% by weight).
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0621-2/jp cc: Bob Campbell
Connie Dillon Mark Hross
BFG21004
BFGoodrich
3FGooanc~ Cor-oarv 3925 Emeassv Partway Akron. Ohio 44313-1799
May 13, 1991
Mr. Michael Becker 'p 6 J ' 3/' 7_ 3 6
Clintec 3 Parkway, North Suite 200 P. o. Box 760 Deerfield, IL 60015-0760
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SUBJECT: PVC RESIN FDA STATUS
Dear Mr. Becker:
At your request, I an writing to you regarding the FDA status of Geon 110X500. Polyvinyl chloride is prior sanctioned for use in general food contact applications, both flexible and rigid. The prior sanction is based on an article by A. J. Lehman, from the FDA, published in the Journal of the Association of Food and Drug officials. July, 1951. The current Good Manufacturing Practice (GMP) specifications for prior sanctioned PVC are a maximum volatility of 3.0% (l hour at 105C) and an inherent viscosity of not less than 0.35 by ASTM D-1243-79.
PVC is also listed as an acceptable ingredient of food contact articles under 21CFR:
175.105 175.300 176.180 177.1010
177.1200 177.2250 179.43
If you have any further questions, please call me at 216/374-4534.
Sincerely,
THE BFGOODRICH COMPANY
Manager, Health and Toxicology Environment, Health and
Safety Management Systems
0513-l/jp
cc: Mark Hross
BFG21005
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BFGoodiich
The BFGoodrich Company 3925 Embassy Parkway Akron. Ohio 44313-1799
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June 25, 1991
Dr. George Wilson
Food and Drug Administration Center for Drugs and Biologies Central Document Room 12420 Parklawn Drive Room 2-14 Rockville, Maryland 20852
SUBJECT:
MAF Number Assicrned: MAF-369 Date of Submission: Mav 20. 1991 Title of Submission: Geon 87390 trans 004 Holder of Submission: BFGoodrich
sufc>mifctg<L 6YJ___________ BFgQ<?dri,<?h
Agential.;Nana
Dear Dr. Wilson:
This letter is the FDA's authority to refer to MAF-369 for the information contained therein on Geon 87390 trans 004 in the review of any of your premarket approval applications (PNA's), investigational device exemptions (IDE's), premarket notification submissions, reclassification petitions, color additive petitions, or other submissions to the FDA. You should include the original copy of this letter in the original copy of your submission to the FDA in order that your submission will not be found deficient for the lack of authorization and to expedite processing.
Any Geon 87390 trans 004 supplied to you for this purpose will comply with the product specifications contained in MAF-369.
Sincerely,
THE BFGOODRICH COMPANY
Robert K. Hinderer, Ph.D. r Manager, Health and Toxicology Environment, Health and
Safety Management Systems
RKH/jp
cc: Mark Hross
10069*22
BFG21006
JUN 1*891
To : J. Edward Fattlar From: Lance A. Mayer
RetTj^DAP Extractions
cc: Keith L. Gardner Bob K. Hinderer Bernie C. Knoble Bud Pazur
Ashok Shah D'Lane L. Wisner Roman W. Wypart File
June 1
Summary: Higher than normal conversion Geon 3400 was used to make a "Mystique" bottle compound with 25 parts of Geon 3400. The bottles were extracted with both 8% ethanol in water and 50% ethanol in water. No residual DAP was found in the extract. The test had a detection limit of 50 parts per billion (ppb).
Discussion: In order to get FDA approvability for the "Mysitic" resins, the resin was modified to obtain a lower residual diallyl phthalate (DAP) level. The modification involved running the reaction to a 15 psi pressure drop rather than the usual 3 psi pressure drop. This was expected to increase the conversion approximately 5%. In the one polymerization made under these conditions, the extra 12 psi pressure drop took one hour to obtain.
A sample of the slurry was obtained and dried in the dryer at the Technical Center. The resin was then compounded by Roman Wypart into the 87536 formulation using 25 parts of Geon 3400 rather than the conventional 20 parts used in the current "Mystique" compound. Earl Price then blowmolded the 12 ounce bottles from this compound to be used in the extraction study.
Brenda Bennett then extracted the bottles using 8% ethanol and 50% ethanol to simulate contact with aqueous foods and alcoholic foods following the protocol in "Guidelines for Migration Studies for FDA Acceptance of Indirect Food Additives" by Wellman C. Bachtel, January 29, 1990. These extractions extended over the course of 10 days. For the first two hours the bottles were stored in a convection oven at 150F. For the rest of the time the temperature was maintained at 120F. Samples were removed from the three bottles at 2, 8, 24, 48, 96 and 240 hours.
A modification of Dave Ernes's procedure was initially used. This new procedure involved the evaporation of the water and ethanol, re-dissolution in acetonitrile and then analysis via high pressure liquid chromatography. This produced acceptable results in the validation study of the 50% ethanol/water (see Table 1). However, it was discerned that in the samples that were allowed to evaporate overnight (namely the 8% ethanol), an appreciable amount of the DAP also evaporated. This was despite its very low vapor pressure of
22470001
BFG21007
about 0.001 mm Hg at ambient temperature. (The vapor pressure of water at 70F is 18.8 mm Hg).
A procedure was then developed that permitted the analysis of the extract directly. (This approach had been abandoned earlier because of the interference of the methanol that was in the ethanol.) This gave acceptable results in the validation, (see Tables 2 and 3).
Experimental: Calibration standards were prepared by dilution of DAP into both 8% and 50% ethanol solutions. Standard curves were prepared based on peak height (see Figures 1 and 2). Peak height correlated better than area due to baseline determination.
Prior to injection, the extracts were filtered through a 0.45 n Gelman
filter. The following chromatographic conditions were used:
Column: Mobile phase: Flow rate: Injection Vol Detection:
Varian Reverse Phase C18, 45/55 acetonitrile/water 1.8 ml/min
20jxl UV at 220 nm.
MCH-NCAP-5/x
Figure 3 is the chromatogram of a direct injection of 50% ethanol. Figure 4 shows the chromatogram of a direct injection of the 240 hour extraction sample of a bottle (no peak attributed to the DAP). Figures 5, 6 and 7 show the validation chromatograms where the 240 hour extract sample was spike with 50, 100 and 150 ppb of DAP to determine the recovery percentage. The peak attributed to the DAP had a retention time of "6.3 minutes. Figures 8 through 12 show similar chromatograms for the 8% ethanol.
Conclusions: Geon 3400 should be FDA approvable where the contents are 0 to 50% ethanol in water or for contact with fatty foods.
Since the amount df time required for the extra 12 psi pressure drop was inordinately long (an extra hour of polymerization time), the polymerization should be repeated. If it remains this long, the initiator system should be reviewed as well as the possibility of repeating the extraction on normal Geon 3400,
Acknowledgments: I am indebted to: Brenda Bennet for her expeditiously getting this testing done; Daren Whetstone for arranging the polymerization and obtaining the
resin; Roman Wypart and Earl Price for making the compound and bottles; and
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Table 1 Percent Recovered from 50% Ethanol/Water Extract
Evaporation Technique
ppb
Results
Average
150 100
50
82.3 98.8 103
84.8 79.9 65.3
84.8 89.4 65.3
84.0 89.4 77.9
Table 2 Percent Recovered from 50% Ethanol/Water Extract
Direct Analysis Technique
ppb
Results
Average
150 100
50
99.4 74.4 74.0
94.4 104.3
74.0
99.4 104.3
59.1
97.7 94.3 69.0
Table 3 Percent Recovered from 8% Ethanol/Water Extract
Direct Analysis Technique
ppb
Results
Average
150 100
50
84.9 73.8 84.0
90.0 86.4 98.8
100.1 79.0 83.9
91.7 79.7 88.9
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Peak Height
Figure 1
DAP CALIBRATION in 8% EtOH
40 60 80 100 120 140 160 DAP (ppb)
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BFGoodrich
The BFGoodrich Company
3925 Embassy Parkway Akron, Ohio 44333-1799
FAX:
216-374-2333 216-374-2238 216-374-3338 216-374-3456
1st Floor 2nd Floor 3rd Floor Legal
DATE:
June 4, 199t
TO: Chuck Purks ALTC
V' PHONE: Fax: 933-1678
NUMBER OF PAGES:
1 (INCLUDING COVER PAGE)
COMMENTS: RE: GEON 86155 TRANS 0025
Please check the following:
1) I cannot confirm that Synpron 221 is FDA acceptable. I cannot find trisnonyiphenyl phosphite in any of the sections quoted: 181.29,181.27,178.2010. The supplier should be asked under what sections) would Synpron 221, and not the individual components, be cleared. Also, under what section is TNPP cleared?
2) The supplier for P057 does not list 181.27, a Prior Sanction for EPLSO. Does this product meet 21CFR specs: iodine number maximum 6; oxirane oxygen, minimum 6 percent? Will they certify that it meets 21CFR 181.27?
FROM:
Bob Hinderer_________ BFGoodrich - Corporate
PHONE: 374-4534
4/91 JJP
BFG21016
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