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Keller and Heckman
1190 IT" STREET, N. W.
SUITE lOOO
Washington, d. c. aoose
AUG 26 1983
003) 4DT UOO
August 23, 1983
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202/457-1110
TO:
SPI SPI
SPI SPI SPI SPI
Vinyl Institute Food, Drug and Cosmetic Packaging Materials
Public Affairs Committee Plastic Bottle Institute Plastic Beverage Container Division AN Polymers Group
Committee
Re: PVC Market Survey
Ladies and Gentlemen:
We have finally completed the survey of the food contact uses of polyvinyl chloride (PVC) and its copolymers requested by the Food and Drug Administration (FDA). A copy of our letter forwarding the survey to FDA along with the results is enclosed. We believe you will find the letter and data self-explanatory.
The ultimate goal of the survey was to provide FDA with data for calculating a consumption factor, that is, for determining the percentage of the diet packaged in PVC so that it can conclude, as we have, that currently
available PVC materials are safe for all food contact applications. According to the results of the survey, approximately 7.8% of the diet is currently packaged in PVC materials. If FDA takes positive action in 1983 confirming the suitability of PVC for all food-contact applications, the survey projects that the per cent of the diet packaged in PVC will increase in five years to ll.'2%. As our letter to FDA indicated, it is the industry's position that these data justify removal of
the by now proverbial "little black cloud" over the food additive status of the polymer.
So far as we are aware, this is the first time that a survey of this nature has been conducted by The
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August 23 1983 Page Two
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Society of the Plastics Industry, Inc. (SPI). The methodology developed is adaptable to other types of plastics so similar surveys may be feasible in the future if the need arises.
The success of the survey is a tribute to the efforts of the members of the Vinyl Institute, other SPI members active in the PVC food-contact market such as Occidental Chemical, American Hoechst, Ethyl Corporation, Klockner Pentaplast and Union Carbide, as well as outside groups such as the Institute of Shortening and Edible Oils and Proctor & Gamble Company, we wish to take this opportunity to thank all of those who assisted in the effort.
We are hopeful that the completion of the survey will permit FDA to clarify the regulatory status of PVC soon so that, among other things, our long-standing push for reapproval by the Bureau of Alcohol, Tobacco and Firearms (ATF) of PVC liquor bottles will bear fruit. In the interim, if you have any comments or questions on this matter, please feel free to contact us.
ially yours,
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Enclosures
H. Heckman
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Keller and Heckman
1130
STBZ8T, W. W.
SUITS lOOO
WX3HJKOTOK, D.C. 30034
(303) A37 -UOO
August 17, 1983
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(202) 457-1110
Dr. Sanford Miller Director, Bureau of Foods Food and Drug Administration Washington, D.C. 20204
Re: Polyvinyl Chloride; Market Penetration Survey
Dear Dr. Miller:
In our letter dated June 29, 1983, we informed you that The Society of the Plastics Industry, Inc. (SPI) was conducting a survey at the request of the Food and Drug Administration (FDA) to provide an estimate of the extent of current usage of polyvinyl chloride (PVC) plastics in food-contact applications as well as an estimate of the quantity expected to be used five years after action by FDA restating the satisfactory status of the polymers under consideration. The survey was conducted utilizing the questionnaire form reviewed by your staff and modified in accordance with its recommendations. The details of the data collected, the assumptions made in analyzing the data, and the calculations made are set forth in complete detail in the enclosed report. Because different types of PVC plastics are manufactured by different technologies, it is appropriate to consider them discretely. Accordingly, our survey presents separately the market penetration results for each of the dif ferent types of PVC plastics.
In 1975 (40 Fed. Reg. 40,529 (Sept. 3, 1975)), FDA pro posed to reaffirm the prior-sanctioned status for several vinyl chloride products including plasticized film, gasket, capliners, and can coatings for use in contact with food. This proposal was based upon the understanding that there was no reasonable expectation that vinyl chloride would become a component of food as a result of these applications. Despite the major im provements in the sensitivity of analytical methodology since, there is no basis for changing this conclusion.
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Dr. Sanford Miller August 17/ 1983 Page 2
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For these products, where the status of PVC has never been questioned, the five-year projection represents only a modest proportional increase over current use, 9.52% compared to 7.3%. For other applications, particularly rigid and semirigid containers and sheet, the 1975 proposal evidenced concern. Here the five-year projected proportional increase is significant. Nevertheless, although the total fraction of the diet projected to contact all PVC products is approximately 11%, you will observe that the projected mature market for the rigid and semirigid products will involve contact with a maximum of only 1.7% of the diet. Thus, the data we have gathered regarding the rigid and semirigid products shows the existence of a very wide margin of assurance that the informal "very safe" level of vinyl chloride in the diet will not be approached. (You will recall that in our letter of November 12, 1982, we showed that even if the entire diet were packaged in PVC containers meeting the specifi cations discussed therein, the potential migration of vinyl chloride would be well below the very safe level.)
The information upon which SPI relied has been provided through the cooperation of members of the Vinyl Institute of SPI, other SPI member companies, the Institute of Shortening and Edible Oils, Inc., and Proctor and Gamble. Their assistance has been invaluable and is hereby gratefully acknowledged.
We trust the report we are providing will assist your staff to proceed forthwith to complete its review of the PVC matter and remove the subjectively induced doubts some seem to have about the status of this very valuable class of packaging materials. If there are any questions concerning the data sup plied, or if there is anything more that we can do to assist in any way, please let us know.
Very truly yours,
'mm*.
Enclosure
Jerome 3. Heckman
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REPOST OB POOD CONTACT USAGE OF FTC PLASTICS Prepared by
Keller and Heckman For
The Society of the Plastics Industry, Inc. August 17, 1983
BFG05474
S u O frS iO Z
ABSTRACT
A survey was conducted by The Society of the Plastics
Industry, Inc. to show the percentage of the diet now packaged
in various types of PVC plastic products and the percentage
projected to be so packaged in 5 years, assuming appropriate
FDA action to reaffirm the satisfactory food additive status of
these polymers. The following table summarizes the results.
Percentage of Diet Packaged in PVC Products
Tvoe of PVC Product
Current Usage, % of Diet
5-Year Projected Usage, % of Diet
Rigid Bottles, Jars Rigid Sheet, Film Plasticized Film Coatings Plastisol, Cap Liners
and Gaskets
0.083 0.438 5.35 1,95
N/A
0.73 0.93 7.43 2.09
M/A
Footnotes N/A data not yet available but will be provided as soon as possible.
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BFG05475
IHTRODOCTIOH
At the request of the Food and Drug Administration (FDA), The Society of the Plastics Industry/ Inc. (S?I) undertook a survey intended to provide information about the extent to which vinyl chloride-based plastics, referred to hereinafter as polyvinyl chloride plastics or PVC, are used in food-packaging applications. At FDA's request, information has been provided regarding both current levels of utilization and those that are expected to result five years after FDA confirms an appropriate food-contact status for PVC materials.
The information relied upon in preparing this report was supplied by members of SP1, the Vinyl Institute of S?X, the Institute of Shortening and Edible Oils Inc., and Proctor and Gamble. Their cooperation, advice and active assistance is hereby gratefully acknowledged.
To obtain the information needed, a questionnaire was developed and modified on the basis of recommendations made by FDA. The questionnaire asked for estimates of the size of the market for PVC resins both at present and five years from now. To facilitate interpretation these estimates were allocated to different food groups and to different types of PVC products. A copy of the questionnaire with instructions for responding to it is attached as Appendix I.
The questionnaire was distributed to the manufacturers of the basic PVC resins. While it might have been preferable
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to request data from converters and processors who manufacture the PVC packaging materials and the food companies that might utilize PVC for packaging food products, it was completely in feasible to contact a cross-section of these organizations. Accordingly, the basic resin manufacturers who were contacted were asked to refine their estimates by consulting with their customers, i.e., the converters and processors of the finished packaging materials and even food manufacturers and distributors to the extent possible. In addition, a number of SPI member producers of packaging materials provided their own estimates for the products with which they were familiar. Finally, the Institute of Shortening and Edible Oils, Inc. and Proctor and Gamble both provided valuable cooperation by supplying refined ( ' estimates of both the quantity of food products expected to be packaged and anticipated usage of PVC containers.
DATA UTILIZED
In addition to the estimates of PVC usage, information was needed to derive a value for the percentage of the diet that was packaged in PVC products. The following types of information were utilized:
(a) the weight or volume of contents of a typical or representative PVC package for each food group and type of PVC;
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(b) the weight of PVC compound utilized in the typical or representative package;
(c) the percentage of PVC resin in the typical compound?
(d) the annual weight of each of the food groups consumed in the United States and the percentage of the diet represented by this weight of food.
Estimates of the size of typical packages, the weight of PVC compound utilized in such packages# and the percentage of PVC resin in the compounds were provided by packaging experts on the staffs of the cooperating companies. These are shown in Appendix IV. The estimates of the quantity of the various food groups consumed were averages calculated from the data provided in Appendix A of the Documentation for the Revised Total Diet Study: Pood List and Diets by J. A. T. Pennington published by the Food and Drug Administration# May, 1981. These were supple mented with the further assumptions that the average daily intake of food is 3 kilograms (6.6 pounds) and that the total population is 234 million people. The assumption was made that the density of the various food products was one gram per cubic centimeter but this was modified in a few cases where that value was clearly inappropriate.
In a few cases, the FDA dietary data were not available as in the case of some dry fodds (e.g., flour) or bottled water.
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Possible PVC uses in these areas were omitted, but these omis sions are not deemed to be significant because the projected volumes of PVC were small or were subsumed in other food cate gories.
No data are included regarding flexible but unplas ticized products. We understand that the major manufacturer of these materials has independently provided market data to FOA. We further understand that any contribution of vinyl chloride to the diet from this source is extremely minute.
CALCTJLATIOH
The estimated total consumption of each type of PVC product for each food category was used as the basis for cal culating the percentage of the total diet accounted for by the PVC-packaged food group. By way of example, the following typi cal calculation demonstates how the values shown in Appendix II, Percentage of Diet in PVC Products, were derived. Using the food category "non-alcoholic beverages" as the example. Appen dix III, Estimates of PVC Usage, shows current usage to be esti mated at 200,000 pounds and future usage at 2.6 million pounds. A typical container size has been estimated at 24 fluid ounces (this is an average value), the corresponding container is esti mated to weigh SO grams, and the compound to contain 85% PVC resin. The average percentage of the diet occupied by this category of foods, as determined from the FDA reference, is 10.037% and the corresponding weight of the food group consumed is 5.658 X IQ10 pounds. These data are used as follows:
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1. Weight of compound, g: 2 * 105 lbs comp'd x 453.6 g/lb 907.2 x 10s g comp'd
9.07 x 107 g comp'd
2. Weight of PVC, g:
9,07 x 107 q comp'd
0.85
PVC
PVC comp'd
10.67 x 107 g PVC * 1.067 x 103 g PVC
3. The number of containers * 1.067 x 108 q PVC 0.0213 x 108 2.13 x 106 containers
50 g PVC container */ 4. Weight of food packaged--':
24 fl os x 2.13 x 10 containers x 1.04 ox avoir
container
fl ox
53.26 x 10 ounces avoir 3.32 x 10 pounds
5. Weight of food consumed, pounds: 5.66 x 1010 pounds
6. Fraction of food in PVC: 3.32 x 10 lbs packaged * .587 x 10~4 5.87 x 10~ 5.66 x IQ10 lbs consumed
7. Percent of diet in PVC: 10.04% x 5.87 x IQ"5 - 5.89 x 10"4 %
Appendix III shows the five year estimate of PVC usage to be 2.6 x 10 pounds. This is 13 times greater than the
*[/ At a density of 1 gram/cc, 1 fluid ounce weighs 1.04 ounces avoir.
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200,000 pound value used in the foregoing estimate. Conse quently the percentage of diet represented by non-alcoholic beverages packaged in PVC is 13 times the present figure or 0.00766%.
SUMMARY
Appendix II shows the values of the percent of the diet represented by each of the entries. The totals for each of the types of PVC are tabulated below:
Percentage of Diet Packaged in PVC Products
Tvoe of PTC Product
Current usage, % of Diet
5-Year Projected Usage, % of Diet
Rigid Bottles, Jars Rigid Sheet, Film Plasticized Film Coatings Plastisol, Cap Liners
and Gaskets
0.083 0.438 5.35 1.95
N/A
0.73 0.93 7.43 2.09
N/A
Footnote: N/A data not yet available but will be provided as soon as possible.
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BFG0548^
APPENDIX I
PVC Pood-Contact Market
SURVEY FORM
General
This survey is being conduced by Keller and Heckman on behalf of The Society of the Plastics Industry, Inc. The survey responds to a request by the Food and Drug Administration on the*current and project markets for food-contact substances that may contain vinyl chloride. For each class of foods, enter your estimate of the total market (not your company's share) for single-use containers for each type of polyvinyl chloride (PVC) product shown. The PVC products covered by the survey include all PVC homopolymers and all copolymers containing vinyl chloride. The estimate should be in pounds of resin only, not of formulated end-product. For example, if an end-product con tains 18 parts per hundred of resin (phr) of additives, report only the 100 lbs of resin, not the 118 lbs of end-product.
Please provide your estimate for the current market indicating the year to which "current" relates, and for the 1988 market assuming that FDA takes positive action in 1983 confirming the suitability of PVC for all food-contact applica tions.
Please mark with an asterisk (*) those entries for which you expect to market resins.
Definitions
For this survey, use the following definitions:
"Rigid" means a product with a modulus greater than 100,000 lbs per square inch (psi).
"Semirigid" means a product with a modulus be tween 10,000 psi and 100,000 psi.
"Flexible" means a product with a modulus less than 10,000 psi.
"Plasticized" means a product with more than 10 phr of external plasticizer.
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"Film" means a layered product less than G.010 in. thick.
Sheet" means a layered product 0.010 in. or thicker.
Codes for Different Vinyl Chloride Containing Products
Product
Code
Rigid and semirigid film Rigid and semirigid sheet
Rigid and semirigid containers [All types: bottles, jars, cans, etc.]
Flexible, Flexible, Flexible, Flexible, Flexible,
plasticized film plasticized sheet plasticized other unplasticized film unplasticized other
Coatings
Plastisols and organosols
A S C
0 2 F G 3
J
K
Food Classes
Fluid Milk includes whole, low fat, skim milk.
Processed Milk Products includes fluid products such as butter milk, yogurt, chocolate milk.
Cream includes half and half, light cream, heavy cream, sour cream.
Ice Cream includes sherbert, frozen yogurt, frozen custard.
Meat, Fresh includes all varieties (beef, pock, poultry) and cuts (steak, roast, ground)^
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Heat, Frozen includes all varieties (beef, pock, poultry) and cuts (steak, coast, ground).
Meat. Cured includes all types of wurst, smoked meats, hot dogs. Fish includes fresh, frozen, cured (smoked). Canned Meats and Fish includes Spam, canned tuna, canned cocned
beef. Oil includes mayonnaise, salad dressing. Butter includes margarine, other table spreads. Shortening includes lard, hardened oils. Non-Alcoholic Beverages includes cola, carbonated drinks, fruit
drinks, juices (not frozen). Alcoholic Beverages fbeerl includes beer, ale, other malt bever
ages. Alcoholic Beverages fwinel includes wine, fortified wine. Alcoholic Beverages Thigh alcohol] includes whiskey, cordials
(40-proof or greater) Fruits and Vegetables, Fresh Fruits and Vegetables, Frozen includes frozen juices. Fruits and Vegetables Tin cans or iarsl includes meat-contain
ing stews, chowders and soups, vacuum-packed nuts, ketchup, tomato juice. Nuts. Shelled includes everything but "vacuum packed." Powdered Dry Foods includes "instant" soup, bouillon, powdered milk, powdered chocolate drink, sugar, flour. Cereal Grains includes oatmeal, farina, grits. Cereal (Readv-To-Satl includes corn flakes, shredded wheat, bran flakes, sugared flakes with raisins.
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4 Bread includes all types of bread, biscuits, pasta, noodles. Tea. Cogfee. Cocoa includes tea leaves, ground and instant cof
fee, cocoa powder. Desserts include cake, pastry, pie (including frozen), candy. Preserves include jams, jellies, marmalade, peanut butter. All Other Prosen Poods and Meals Spices. Seasonings, Condiments includes pepper, salt, cinnamon,
oregano, mustard. water includes spring water, mineral water. Other TPlease Specify)
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S P lO trS A O Z
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CODS IN THOUSANDS OP POUNDS OP RBSIN PBR TEAR. IP ML TUB "CURRENT" E8TJHATV8 ARB BASSO UPON TIIB BANS TINS PENIOO, PLSASS STATE TUB TKAA|e| AT TBB BUTMI OP TUB TABU. IP DIPPENMT TIMS PBR10O3 ARB 1HVOI.VBD, PUASS STATE TUB THAR(S| IN TUB MMNfUMIS. UB BNTBT PON IMS MOULD M A MARKET PROJECTION BASSO ON TUB ASSUMPTION THAT PDA TARES POSITIVE ACTION IN 1M1 C0NPIBM1N0 TUB SUITABILITT OP ALL PVC POOD CONTACT U8BBS. PLBASB MAM MITE AM ASTERlBB |"| TUOSS BfTRIRS FOR MHICM TOO
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Canned Heats and Plait
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Alcoholic Bera9aa (beer I
Alcoltolic MvttagM Ninel
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Powdered Dry Poods
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Current I
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3 Tear
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