Document O368g8zQD3LzXwdo5xQxN8mOX
71
7.2.3 Soil
Monitoring data for vinyl chloride in soil were not located in the available literature.
7.2.4 Other
In the past, vinyl chloride had been detected in various foods as a result of migration from polyvinyl chloride food wrappings and containers (EPA 1985b). Vinyl chloride has been found in vinegar at levels up to 9.4 ppm, in edible oils at 0.15 to 14.6 ppm, and in butter at 0.05 ppm when these foods were packaged and stored in PVC containers (IARC 1979). At present, the Food and Drug Administration (FDA) regulatea use of vinyl chloride polymers available for use in production of articles intended to contact food. These articles include food' packaging materials, coatings, plastlsols, gaskets, and parts for foodprocessing (see Sect 9, Regulatory and Advisory Status). A recant study on the migration of vinyl chloride from PVC under conditions closely simulating actual food packaging and storage revealed that at very low concentrations of vinyl chloride in PVC packaging material, there was essentially zero migration of vinyl chloride (Kontomlnas et al. 1985).
It is reported that migration of vinyl chloride from rigid PVC water pipes into drinking water occurs, and that It is directly proportional to the residual level of vinyl chloride in the pipe itself. Under certain conditions, reaction with chlorine in the water may rasult in tha complete removal of vinyl chloride from drinking water (Flshbeln 1979, Ando and Sayato 1984). During one study, It was found that drinking water which ran through recently installed PVC pipes contained vinyl chloride at 1.4 pg/L, while water which ran through a 9-year-old system contained 0.03 to 0.06 pg/L (HSDB 1987). This suggests that use of PVC pipe In water distribution systems contributes to Intaka of vinyl chloride through ingestion of contaminated drinking water. Assuming that the average daily Intake of water is 2 L, the average Intake of vinyl chloride from water contaminated with vinyl chloride from PVC pipes is expected to range from 0.06 to 2.8 pg/day.
The interior air of two new cars was analyzed and the level of vinyl chloride was found to range from 824 to 3120 jig/m^ (0.3 to 1.2 ppm) (EPA 1985b). The source of vinyl chloride was believed to be volatilization from vinyl plaatica found in the car interiors. Levels of vinyl chloride in the air In new cars may exceed estimates of minimal risk lavals for acute and intermediate exposure.
Vinyl chloride has been detected In tobacco smoke (EPA 1985b). Clgarettee and little cigars have been found to contain 5.6 to 28 ng vinyl chlorldo per cigarette (IARC 1979).
7.3 OCCUPATIONAL EXPOSURES
NIOSH estimates definite worker exposure to vinyl chloride to be 27.000 persons and probable worker exposure to be 2.2 million (Slttig 1985). This includes >5000 workers employed in vinyl chloride synthesis, 5000 workers Involved with polymerization procassas, and as many as 350.000 workers associated with fabrication plants. Exposure is believed to occur primarily through inhalation and less frequently by absorption
BFG21225
22490013
72
through skin (Sittig 1985). In the peat, concentrations of vinyl chloride In workplace air In some plants producing PVC have been reported to range fron 100 to 800 mg/m^ (39 to 315 ppm) with peak concentrations up to 87,300 mg/m^ (34,000 ppm) (IARC 1979). Currently, the Occupational Safety and Health Administration (0SHA) sets standards for occupational exposure to vinyl chloride (see Sect. 9, Regulatory and Advisory Status). A recent NIOSH survey of three vinyl chloride plants indicated that the time-weighted-average exposure to vinyl chloride varied between 0.2 to 70 mg/m^ (0.08 to 27 ppm) (IARC 1979).
7.4 POPULATIONS AT HIGH RISK
Data were not located specifically regarding subpopulations unusually sensitive to the effects of vinyl chloride. Individuals located near or downwind of production facilities, hazardous waste disposal sites, and landfills nay potentially be exposed to higher ambient atmospheric levels.
Workers involved in the production or polymerization of vinyl chloride may constitute a group at risk because of the potential for occupational exposure. Since the mid 1970s, however, atmospheric levels In the workplace have often been reduced to si ppm (Flshbeln 1979, Klllan et al. 1975, Hansteen et al. 1978). Occupationally exposed men may represent a sensitive subgroup because occupational exposure In men has been associated with an Increased incidence of fetal loss in their wives (Infante et al. 1976, Vaxweiler et al. 1977). No threshold concentration has been determined for this effect. Women (or couples) of child-bearing age may constitute a group at risk, because data suggest that ambient exposure to low (but not quantified) environmental levels is associated with an increase in the Incidence of malformations at birth (Infante 1976; Edmonds et al. 1975, 1978; Theriault et al. 1983). No threshold has been determined for this effect.
Inhalation studies in animals demonstrated that exposure early in life resulted in greater risk of developing cancer than did exposure later in life (Drew et al. 1983). Although human studies that address the effect of age on cancer risk were not located, the animal data suggest that exposure during the younger years nay result in increased cancer risk. Other animal studies suggest that prenatal exposure may Increase cancer risk (Maiton! et al. 1980, 1981). Although human data were not located, the animal data may suggest that the prenatal exposure of humans to vinyl chloride may Increase risk of cancer.
Animal studies have demonstrated that pretreatsMnt with xenoblotlcs or drugs that induce mixed-function oxidase (KPO) potentiates the hepatotoxicity of vinyl chloride (Jaeger et al. 1974, Reynolds et al. 1975, Conolly et al. 1978). Although human data were not located, the animal data suggest that human exposure to environmental pollutants or drugs that Induce MFO may result in increased sensitivity to vinyl chloride.
BFG21226
WOOSHJZ
It
August 30/ 1991
Jim Gray SUBJECT: FDA SUBMISSION STATUS/GEON PRODUCTS Attached are status updates on several Geon products you requested to be submitted to FDA. All of the referenced products have, at least 1 ingredient that does not have FDA clearance. If the particular application (use) of the product falls under the Housevares Exemption, we prefer that you substitute the indicated ingredient with an FDA-approved one. We will re-evaluate the application if substitution is not possible.
0830-3/jp Attachments (5)
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BFG21227
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FDA. USPA. NSF. WORKSHEET
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DATE: COMMENTS/STATUS:
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BFG21228
07/22/91 11:05 9216 447 6606
BFC GEON VINYL U
JUL 19 '91 13i40 FROM BFGOODRICH GEON D3052 TO 9-10BG0S
PAGEluu*
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110x377 Paralold X-120-N
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80.354 I
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K-26^>H 14,000 | 11.249 | S-86*^> 1.900 \ 1.527 {
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2.00ft \ 1.607 !
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L-22t<>f 0.200 ! 0.161 !
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EFFECTIVE DATE: 01/01/91
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72.72600 36.36300 12.12100
INGREDIENTS
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LOC! 67 DEPT* 4212
ISSUE:
EFFECTIVE DATE* 01/25/91
DELETE FLAG* NO
CMPR* W. FAY/CVP
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FDA. USPA. NSF. WORKSHEET
SUBJECT: JlX/jrU-s T1Sl4I QdtUiA. Al'f?'
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DATE:
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BFG21238
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IHTEROPPICB MEM O R A D 0 M
Date: Iromi
Dipt! Tel Vos
19-Jul-1991 11:37am EDT JIM GRAY
GRAY, JIM D/5384
;Y ( GRAY, JIM )
Subject: G.E. Bob Hinderer.
Further to our discussions concerning the housewares exemption status of 87241 for incidental food contact, X have additional questions and products for review.
Last time, you looked at 87241 black and identified the carbon black as the only potential problem. Have we recieved any statement from.the carbon black supplier? if so, please send me a copy and advise if we are clear.
Secondly, x am enclosing the following recipes :
37241 White 126 B7241 White 1364 37371 White 1364 and X-1501-650-4901
Please review the 87241 recipes to see if the pigment systems are acceptable per the incidental food contact housewares exemption standards.
Then, please review the 67371 and experimental recipes to identify any areas of concern relative to incidental food contact applications. These are primarily targeted for refrigerator through the door ice and water dispenser housings. i tfould appreciate a letter similar to the one you faxed concerning the 87241 if in fact these formulations look acceptable, Xf not, please identify which aaterials are of concern.
22435003
rhanks
Jim Gray
PH, - 6637
?ax - 6605
Xv
BFG21239
September 9, 1991
Chuck Bush
SUBJECT: VI UPDATE
The Medical Committee presently has two outstanding activities. We are giving top priority to the completion of the remaining three papers on the primate/rodent studies with PVC/HC1 which were conducted at SWRI. We plan to subsit these to the VI for approval by the end of September and, subsequently, to Fundamental and Applied Toxicology for publication.
Because of the importance of publishing this work and the pressing matters, we will not devote any time to the monograph project until the primate studies have been submitted for publication. Practically, we would not be in a position to complete the monograph until these studies are published anyway. Once we resume this process, I will ask Drs. Hirschler and Kaplan to take prime responsibility for the combustion and toxicity areas, respectively. I will provide editorial/technical oversight.
One other item which I should mention is Roy Gottesman's request for comments on the mouse as a model for indoor air pollution. Clearly the mouse is a poor model for primates (i.e., man) with respect to the prediction of HC1 lethality and the potential to cause pulmonary damage. However, from a purely theoretical point of view, the mouse "model** should be able to predict the relative irritancy of HC1. While Alarie et al. have published some information in this area, I am not certain that they have convincingly shown this to be the case. Therefore, it would be reasonable to ask Anderson Laboratories, Inc. to present their best case (supporting data)
A final item of interest, although it does not fall under the Technical Committee's activities, is the development of Emergency Exposure Guidelines for VCM. Jim Knaak (Occidental) reports that he will have a draft document to me by the end of September. The ultimate goal is to submit this to AIHA for adoption.
Bob Hinderer
0906-l/jp
BFG21240
23496001
September 13, 1991
Hike Marshall
SUBJECT: CRITIQUE OF "FCB" FETAL TOXICITY STUDIES
In response to your request, I am enclosing some comments on the following papers that you provided:
1. Fein et al. (19841 Prenatal Exposure to Polychlorinated Biohenvls: Effects^on Birth size and^Gestational Age. J. Pediatrics 105f2): 315-320.
This paper is neither well conducted, or well reported. The areas of this study which appear to merit a greater degree of confidence is the analyses of PCBs in cord and maternal serum and the variables measured to assess infant health and viability. Generally, these are less subjective in nature.
The biggest area of concern with this study is the information which was gathered (or not gathered) and how that information was obtained. In any study like this extreme care must be taken in designing the questionnaire and interviewing the participants. The authors appear to have increased the potential for bias by only asking whether or not fish was part of their diet. This not only highlighted or signaled "concern" to the volunteer, but they ignored other potential dietary variables which also could be contributing factors. There is also no mention of how the authors confirmed that the fish came from Lake Michigan. Considering that the authors noted that this was an upper socioeconomic group, it is quite likely their fish was obtained from restaurants (i.e., flown in). In fact, much "fish" is flown into groceries/fish markets.
It is also equally unfortunate that the authors limited their analyses to just one chemical. Numerous chemicals which are also reasonably expected to be possible contaminants in fish are not considered. An even stronger association might have been missed.
Still, the most important finding seems to have been quickly dismissed. Table I shows that in the exposed (fish eating) group, twice as many people consumed alcohol before pregnancy and three times as many consumed alcohol during pregnancy. This observation is very important because alcohol is a known fetal toxin. Although the authors state (Table II) that they adjusted for the effects of alcohol, I'm not convinced. I would like to know how they did it.
BFG21241
22437001
Mike Marshall September 13, 1991 Page 2
Furthermore, it would have been nice to know how many drinks a day were consumed by each participant (a simple question) and whether they were smokers.
I am also concerned about the potential effect of different sample sizes: 71 vs. 242 (Table II). However, I'll leave this to a biostatistician.
In conclusion, good epidemiology studies are hard to design and hard to conduct. This isn't one of them. Alcohol and/or smoking are better bets as causal agents.
2. Jacobson et al. (1990).___Effects of in Utero Exposure to Polychlorinated Biohenvls and Related Contaminates on Cognitive Functioning in Young Children. J. Pediatrics
116(1){ 38-45t
This is the new and improved version of Fein et al. (1984) They probably have learned from peer review and possibly earlier manuscript rejection in other journals. They look at lead and DDT, as well as PCB's. They include smoking. They also record the number of cigarettes smoked and drinks (alcohol) consumed. Unfortunately, this paper suffers from many of the same problems. They do not tell, or perhaps do not test, whether there are correlations with these or other variables
In summary, these studies do not/cannot show that PCB's are associated with fetal toxicity. There are a number of technical issues such as the appropriateness/implication of log transformation of the data (Jacobson et al. (1990), which warrant further in-depth assessment.
If the Chlorine Institute sponsors a more in-depth analysis, I would appreciate receiving a copy.
Bob Hinderer
0911-l/jp
cc: C. Bush R. Gomez C. Mattia
BFG21242
DEPARTMENT OF HEALTH & HUMAN SERVICES
OCT 0 3 89*'
Public Health Service
MAF-379
SEP 2 5 99!
Food and Drug Administration 1390 Piccard Drive Rockville MD 20860
Robert K. Hinderer, Fh.D. Manager, Health and Toxicology Environment, Health and
Safety Management Systems The BFGoodrlch Company 3925 Embassy Parkway Akron, Ohio 44313-1799
Dear Dr* Hinderer:
This acknowledges Receipt of your submission dated August 13, 1991 pertaining to Geon 86155 Transparent 0027*
This material Is retained as a Master File for a device, and it has been assigned the number MAF-379* You may amend this master file to Include additional information at any time. All amendments shall be submitted in duplicate, identified with the above MAP number, and addressed to:
Food and Drug Administration Center for Devices and Radiological Health PMA Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, Maryland 20850
Information in your MAP may be incorporated by your client in their
premarket approval applications (PMAs), investigational device exemptions (IDEs), premarket notification submissions, reclassification petitions, color additive petitions or other submissions to FDA*
Reference to your MAP can only be authorised by you* In order that your client's submission will not be found deficient for lack of an authorizing letter and to expedite processing, please provide it directly to your client with the instruction that the original of your letter be Included in the original copy of the client's submission along with a copy in each additional copy* Under this approach your MAP need not be amended to include the letter of authorization*
If you require assistance regarding device master files procedures, you may contact the Premarket Approval (PMA) Section at (301) 427-1186*
Sincerely yours,
22498001
Mary Jd Robinson Assistant to the Director Premarket Approval Section Center for Devices and
Radiological Health
BFG21243
September 11, 1991
Re: Standard 51 Pedrlcktown, NJ
6^4
NSF International
Mr. W. C. Bechtel B. F. Goodrich 3925 Embassy Parkway Akron, OH 44313
Dear Mr. Bechtel:
This Is to advise that your firm's Listing at Pedrlcktown has been revised for Geon 87256 nat* 021 to add the following:
Geon 87256-010-0210 Geon 87256-020-0210 Geon 87256-Nat 021
/aw cc: Listing
2.28
Robert U# Stevens Manager
S60 & Main Street, Suite 310, Doylactovm, Penmylvenie 18001 Telephone: 21&-340-0680 PAX: 216-340-1277
BFG21244
NSF International
SEP 1SH91
September 12, 1991
Mr. W. C. Bachtel B.F. Goodrich 3925 Embassy Parkway Akron, OH 44313
Subject: NSF Stand 51 Your Letter Dated August--9-. 199J ^
Dear Mr. Bachtel:
I am in receipt of satisfactory acceptance for your additional material designations. Your request is being processed. You should be receiving your Official Listing in the near future.
Please be advised that you are not authorized to utilise the NSF Mark in connection with these trade designations until you receive your Official Listing.
Sincerely,
ratncia a. uaxxowey Service Representative Midwest Region 313-769-5362
PAG:mg/m9.57
cc: J. Paschal
22500001
3476 Plymouth Road, PO Box 130140, Aaa Arbor, Michigan 4611S>0140 USA Telephone: 313-763-8010 PAX: 813-76S-0109 Tehac 763316 NSPINTL
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YES ^ NO `
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9) NAME: ^ScDhn 3- Arf
10) DEPARTMENT NAME:
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11) NSF FAX NO. 313-769-0109
DATE:
TOTAL # OF PAGES. INCLUDING THIS PAGE: 12)
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IF YOU HAVE ANY PROBLEM RECEIVING, CALL 313-769-8010 EXT 223 FOR ASSISTANCE.
BFG21246
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BFGoodrich
The BHSoodrich Cempny on Vinyl Division
6100OakTrs*Sovisvsrd
Cisvsisno, Onto 44131 216-447-6000
August 9, 1991
National Sanitation Foundation
3475 Plymouth Road Ann Arbor, Michigan 48105
C) )*{* ~to /ynrXtd&S
Attention: Mr. Pate Greiner He. Gwen Ball
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Dear Pete and Gwen:
i We are in the process of changing some of our product numbers. These changes will have nothing to do with composition of the material. It will have to do with different amounts of work we put into the compounds. Below are changes we are making:
SID Present Listing 51 Geon 87256 Nat. 021
New Listing Geon 87256-010-0210
Geon 87258-020-0210 Geon 87256 Nat. 021
51 Geon 8700A Gray 244A
Geon 8700A Gray 244A Geon 8700A Gray 244 78710-011-02440
51 Geon 8700A Nat. 022A
Geon 870OA Nat. 022A Geon 8700A Met.'0220
Geon 78710-011-0220 Geon 78710-021-0220
51 Geon 8700A Gray 260A
Geon 8700A Gray 260 Geon 8700A Grey 260A Geon 78710-011-2600
51 Geon 8700A Black 296A
"eon 8700A Black ? >6A Geon 8700A Black '6 Geon 78710--021-29wj
Geon 78710-011-2960
51 Geon 8700A White 119A
Geon 8700A White 119A
Geon 8700A White 119 Geon 7*710-021-1194 Geon 78710-011-1190
51 Geon 8700A White 132
Geon 8700A White 132
Geon 8700A White 132A Geon 78710-011-1320 Geon 78710-021-1320
BFG21247
22500003
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; NSF31 3769801C FRX7690109
87345 Wht 227 14 & 61 (i'.?on 876i Gray 273
Geon 87345 Wht 127 Geon 87345 Wht Pwd 127 Geon 87345-010-1270
Geon 8761 Gray 273 S'
Geon 78761-010-2730 ^
'iffsreftt compound names In your ,e: >ae know if there are any problems and
c.ed,,
Regards,
THE BFGOODRICH COMPANY GEON VI>?yL DIVISION
JCK/ga
cc: R. willing
^Joseph c* Kellejr
Technical Service Manaqer
Q St
BFG21248
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ACCESSION MMER FILE LOCATION DOCttENT TYPE TITLE OR SUBJECT AUTHOR/AFFILIATION ocueiN DATE ABSTRACT
DESCRIPTORS
57
GEN PUBLICATION CONTROL OF EXPOSURE TO POLYVINYL CHLORIDE DUST NONE,NONE HEALTH AND SAFETY EXECUTIVE^GUIDANCE NOT EM 31> 1982, HAY THE HEALTH AND SAFETY COMflSSXCN'S ADVISORY UMUIIkE ON TONIC SUBSTANCES HAS RECOMMENDED THAT, IN LINE MITH THE COMOSSION** GENERAL POLICYt EXPOSURE TO PW DUST SHOULD BE KEPT AS UM AS IS REASONABLY PRACTICABLE! IN ANY CASE EXPOSURE SHOULD NOT EXCEED 10 HG*f3 FOR TOTAL PVC DUST IN AIR AND 5 MB/M3 FOR RESPIRABLE PVC OUST AIR. THE EFFECTS OF EXPOSURE TO PVC OUST ARE REFERRED TO IN PARAGRAPH 9 AND ADVICE IS GIVEN ON ASSESSMENT AND CONTROL IN PARAGRAPHS 10 TO 13. METHODS OF SAMLINS AND MEASUREMENT ARE DESCRIBED IN PARAGRAPHS 1415 AM) THE APPENDIX. PVC DUSTjAIRi STABXLIZERS)PLASTXCffiRS!AHTXOKXDAIfrS!VXNYL CHLORIDE HONOMERlAXR SAHPLXNDiTMA) RESPIRABLE OUSTTOTAL DUSTtDUST SAMPLING)
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Standard Huxbar 51 CBI CDda __________
I. PROGRAM PARTICIPANT
RJT XOTXftHATXOKAJ* CORPORATION
MR. UKXT RAINES
3175 Dusy tMUCHMr rURUW, OH 44333
II. SUPPLXER Baain Notarial Supplla* Notarial T*
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Plant At: MABIWTA, OH 45730
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PO Box 130140 Ann Arbor* MX 4S113-6140
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