Document 5LvDg1xDxeD9Gqz7wZBJpDnJD
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K. W. Birck January 22, 1990
RESIN RECIFE REVIEW
VIS1A
One of the action items agreed to in our October 20, 1989 "FDA Status of Vista PVC" was to review the current resin recipes to assure continued FDA allowance and minimized product liability. Attached are the results of the review to date. It lists all the raw materials required to produce resin and other chemicals that could come in contact with the resin. Also listed for most chemicals is the primary supplier, chemical formula name, products used in, use level, FDA status, and recommended action steps if needed.
A conference call will be scheduled to discuss this information. I will coordinate the call.
Vinyl Operations Engineer
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attachment
Distribution: J. C. Ledvina, B. J. Borsuk, W. L. McClain, D. B. Fenton
cc: R. R. Smith, M. J. Harowitz, T. H. Huffman, H. R. Flammer E. J. Meyer, R. w. Seymour, D. C. Skokna
VEU-145164
FDA REVIEW RESIN INGREDIENTS
I. Catalysts
II. Chain Transfer Agent III. Suspending Agents
IV. V.
VI. VII. VIII.
IX. X.
Kill Agents Antistats Steam Chemicals Residual VCM Inhibitors Anti Oxidants Others
L-10, Trigonox-ehpc75, L-223, L-554,
Trigonox 99C75, L-188, etc.
BME
Alcotex,
Polyvic
S202,
GH-20,
F-50, STP, Span 20-40
AMS, BPA, Isonox
Cast (Dry), Cast (Wet), GMS
BP 5000, Liquimine, Polysperse, Sulfite 3
5265, 5305, 5385, 5395, 5415
Hydroquinone
Isonox, BHT
4
CATALYST
A. L'10
Products: Level: FDA Status:
Recommendation:
Lucidol, t-Butyl Peroxyneodecanoate
5265. 5305
256 ppm
Normal
Basic Resin Doctrine - not separately approved as
an indirect food additive
No action required
B. L-223
Lucidol, Di(2-ethylhexyl) Peroxy-Dicarbonate
Products:
5385, 5395, 5415
Level:
1250 ppm/1850 ppm
Normal/Hax.
FDA Status:
Basic Resin Doctrine - not separately approved as
an indirect food additive
Recommendation: No action required
C. L-554
Lucidol, t-Amyl Peroxypivalate
Products:
5265, 5305
Level:
1025 ppm
Normal
FDA Status:
Basic Resin Doctrine - not separately approved as
an Indirect food additive
Recommendation: No action required
D. Trlgonox - 99C75 AKZO, Alpha-Cumylperoxyneodecanoate
Products:
5415
Level:
1275 ppm/555 ppm
FDA Status:
Basic Resin Doctrine
Recommendation: No action required
VEV-145166
4
II. CHAIN TRANSFER AGENT
A. BME Phillips Petroleum
Beta Mercaptan Ethanol
Products:
5265
Level:
425/2550 ppm
Normal/Max.
FDA Status:
Basic Resin Doctrine - Phillips couldn't provide
any information on FDA usages
Recommendation:
fcxtraction study at 2550 ppm (if product is "made
and 425 ppm
)
>
VEV-145167
A
III. SUSPENDING AGENTS
A. F-50 Dow Products: Level: FDA Status: Recommendation:
Hydroxypropyl Methylcellulose
5265, 5305, 5385, 5395, 5415, 5465
610 ppm
Normal
Basic Resin Doctrine and 21CFR 175.300 XVI
No action required
B. Alcotex 72.5
Revertex, 72.5% Hydrolysed Polyvinyl Alcohol
Products:
5395, 5415
Leve1:
1700 ppm
Normal
FDA Status:
Basic Resin Doctrine
Re commendstion:
Determine if post alcotex injection is BRD
C. GH-20
Nippon Chera Polyvinyl Alcohol
Products:
5265, 5305
Level:
345 ppm
Normal
FDA Status:
Basic Resin Doctrine
Recommendation:
No action required (need vendor statement)
D. Folyvic 5202
3-V Polyvinyl Acetate in Hethano 1/Methyl Acetate
Products:
5265, 5305
Level:
1550 ppm
Normal
FDA Status:
Basic Resin Doctrine and CFR21 175.300 XV
Recommendation: Methanol is stripped. No action required.
E. STP
Harcros Chemicals, Sodium Tripolyphosphate
Products:
None currently
Level:
N/A
FDA Status:
Basic Resin Doctrine if used as a suspending agent
otherwise it can be used to
w>cgo_ia
Recommendation:
Before STP is used again , ensure that It is FDA
allowed
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F. SPAN 20
ICI Americas, Sorbitan Monolaurate
Products:
None
Levels:
N/A
FDA Status:
Basic Resin Doctrine and 21CFR 175.300, 320
Recommendation: No action required
UEV-145168
A
IV. KILL AGENTS
A. AMS
Thompson-Hayward, Alpha Methyl Styrene
Products:
5265, 5305, 5385, 5395, 5415, 5465
Levels:
270 ppm/1000 ppm
Normal/Max.
FDA Status:
Basic Resin Doctrine
Recommendation: No action required
B. Bt-A
Aristech, Bisphenol A
Products:
None
Levels:
N/A
FDA S tatus:
Basic Resin Doctrine + extraction study (185 ppm)
Recommendation: No action required
C. Isonox 132
Schenectady Chemical,
2,6-Di-tert-butyl-4-sec-butylpheno1
Products:
5265, 5305, 5385, 5415, 5465
Level:
Up to 2150 ppm
FDA S tatus:
Acceptable up to 1800 ppm in rigid applications.
No Isonox was detected by extraction at 1800 ppm
use level
Recommendation:
Perform extraction studies at higher use levels
(3500 ppm) in both rigid and flexible applications.
NOTE: This duplicates the information of Isonox as an Antioxidant.
ANTISTATS
A. Calcium Stearate Dispersion (vet)
Mallinckrodt
Products:
5265, 5305, 5385, 5395, 5415, 5465
Levels:
1500 ppm
FDA Status:
FDA acceptable per 21CFRsections
Recommendation: No action required
B. Calcium Stearate (dry)
Witco
Products:
5395, 5415
Levels:
1500 ppm
FDA Status:
Meets requirements of several 21 CFR sections
Recommendation:
No action required
C . Pationic 901
Patco, Glycerol Monostearate
Products:
5265, 5305
Levels:
375 ppm/1000 ppm
Normal/Max.
FDA Status:
GRAS
Recommendation:
No action required
A
VEV-145170
A
VI. STEAM CHEMICAL
Steam is used to strip VCK from all resin products. Steam Usage: 0.2-0.40 lb steam/lb resin.
A. BP-5000 Series
Betz
Addition level to steam: 61.5 ppm
B. Liquimine 14P
Betz
Added to Fluid Bed Dryer
hot water system.
Addition level to FBD: 32.96 #s/day
C. Polysperse Plus
Betz
Addition level to steam: 47.8 ppm
D. Sulfite 3
Betz
Addition level to steam: 43.8 ppm
DBF History and Action Steps Recommendation:
Extraction of
condensate required. Based on the levels of these additives (if any)
in the condensate and theoretical resin concentration calculations
a "No Migration" extraction analysis may be required.
YEV-I45171
4
VII. RESIDUAL VCM
Products: Levels:
FDA Status: Recommendation:
5265, 5305, 5385, 5395, 5415, 5465 Varies * typically less than 700ppb in finished resin Basic Resin Doctrine Continue to meet customer specifications for resin residuals. Since resin residuals are on finished railcars and any cross contamination would have occurred prior to this point, there is no reason to do anything other than meet customer specifications on resin shipments. Keller and Heckman have been contacted to determine if there is any pending regulations on residual VCM at FDA. There is no pending regulation on residual VCM at FDA.
V6V-1A5172
VIII. INHIBITORS
A. Hydroquinone
Eastman Chemical Products
Products:
Hydroquinone is added to recovered VCM to prevent
polymerization in various vessels and lines.
Inhibitors are also added to fresh VCM to prevent
polymerization in transit. 5265, 5385, 5415, 5465,
5395 not 5305
Level:
3.2 ppm
FDA S tatus:
Unknown
Recommendation:
Research FDA status. Is it Basic Resin Doctrine?
IK*
A
VEV-145173
IX. ANTIOXIDANTS
A. Isonox 132
Schenectedy Chemical,
2,6-Di-tert-butyl-4-sec-butylphenol
Products:
5265, 5305, 5385, 5395, 5415, 5465
Level:
Up to 2150 ppm
FDA S tatus:
Acceptable up to 1800 ppm in rigid applications.
No Isonox was detected by extraction at 1800 ppm
use level
Recommendation:
Perform extraction studies at higher use levels
(3500 ppm) in both rigid and flexible applications.
NOTE: This duplicates the Information of Isonox as a kill agent.
B. BHT
Butalated Hydroxy Toluene
Products:
None
Level:
N/A
FDA Status:
21 CFR 175.300 Acceptable
Recommendation: No action required
A
VRM45174
A
OTHERS
A. Shell Turbo 32 Products:
Level: FDA Status: Recommendation:
&
Shell, Turbine Oil Shell Turbo 32 is used as a lubricating oil for the reactor agitator seals. It could enter the reactor should a seal fall. Not added at any specific level. Could be as nigh as 440 ppm if the seal failed. Not approved for indirect or direct food contact. Identify and use an acceptable alternative.
B. Ethanol Neosol 19P
Thompson-Hayward, Ethanol
Products:
5265, 5305
Level:
Possibly as high as 2150 ppm
None, currently used as a carrier for BPA or as
an anitfreeze for Isonox.
FDA Status:
Removed during steam stripping
Recommendation: No action required
c. OMS 55G
Thompson-Hayward Co., Mineral Spirits Odorless
Products:
None
Level:
N/A
FDA Status:
Not acceptable for food contact
Recommendation:
Don't use OMS
D. Caustic
Harcros Chemicals, Inc., Caustic Soda Liquid 50%
Diaph
Products:
Used as a reactor cleaning solution. Reactor is
rinsed after caustic treatment to remove after
caustic treatment to remove residual caustic
Level:
N/A
FDA Status:
Food grades of caustic exist. Our suppliers meet
food chemical codex.
Recommendation: No action required
E. Vlsolite Tracer Compound, BHA Group, Mixture
Products:
Used to test for leaks in rotary dryer baghouses.
not used on 5265 or 5305 dryers yet without several
Level:
weeks of purge. Non-hazardous per manufacturer. 200 ppm
FDA Status:
Not acceptable for food contact
Recommendation:
Purge dryer with material not destined for food
contact use. Test to ensure dryer is cleared
before using again for FDA quality resin.
F. Ultramarine Blue, Akrochem, Sodium Alumino Sulfosilicate
Product:
5305, not currently used
VEV-145175
Level:
500 ppm
FDA Status:
21 CFR 177.2600
Recommendation:
Usage level should not exceed 1%.
No action
required.
A
r<
OTHERS (Continued)
G. Nalco 89RU065
Nalco Chemical
Product:
None, under consideration for testing as a resin
Level:
dewatering agent. N/A
c. 4^^ J&l '
FDA Status.
Acceptable for indirect food contact
^
^
Recommendation: No action required
H. AS-22
Patco, Glycerol Ester
Products:
5415, currently under testing as a Torque reducing
agent for 5415 and others
Level:
2000-4000 ppm
FDA Status:
GRAS 21 CFR Part 174.5
Recommendation: No action required
YEg-145176
