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THE SOCIETY OF THE PLASTICS

INDUSTRY. INC.

250

10017

PARK

AVENUE

•

NEW YORK.

NEW

YORK

•

212/687-2675

MINUTES
MEETING OF SPI FOOD, DRUG AND COSMETIC
PACKAGING MATERIALS COMMITTEE

Shcreham Hotel
Washington. D. C.

March 15, 1972
9:20 a.n.

Present:
Robert M. Miller, General Chairman, Hercules, Inc., Delaware Trust Building,
Wilmington, Delaware 19899
Watson B. Ackart, Union Carbide Corp., River Road, Bound Brook, New Jersey 08805
William Allen, American Cyanamid Co., Bound Brook, New Jersey 08885
Ronald R. Arnold, M & T Chemicals, Inc., Rahway, New Jersey 07065
Robert C. Aaam, The Goodyear Tire & Rubber Co., 1485 E. Archwood Avenue,
Akron, Ohio 44316
W. C. "achtel, B. F. Goodrich Co., 500 S. Main Street, Akron, Ohio 44318
Norman
Bornstein, Cryovac, P. 0. Box 464, Duncan, South Carolina 29334
Foger r.. Boyer, Pantasote Corp. of New York City, 26 Jefferson Street,
Passaic, New Jersey 07055
Kenneth C. Conley, Marbon Division, Borg-Warner Corp., Washington, West
Virginia 26181
Paul F. Cundy, American Can Company, Box 702, Neenah, Wisconsin 54956
Richard A. Dannells, Dart Industries, Inc., P. 0. Box 37, Paramos, New Jersey 07450
LaVerne J. SeCorte, Sindair-Koppers Company, Frankfort Road, Monaca,
Pennsylvania 15061
Daniel S. Dixler, Keller and Heckman, 1150 17th Street, N.W., Washington, D.C. 20036
Dr. Ernest M. Dixon, Celaaese Corporation, 522 5th Avenue, New York, New York 10036
Thomas J. Dolce, Celanese Plastics Co., Box 828, Greer, South Carolina 29651
George V. Ferner, The Goodyear Tire & Rubber Co., 1144 E. Market, Akron, Ohio 44316
Robert P. Fischer, Kerr Glass Manufacturing Corp., P. 0. Box 4000, Lancaster,
Pennsylvania 17604
David II. Fishman, Celanese Plastics, Morris Court, Summit, New Jersey 07901
Gerhard H. Fuchs, Allied Chemical Corp., Box 1057R, Morristown, New Jersey
David R. Gaskill, Mobil Chemical Co., P. 0. Box 240, Edison, New Jersey 08817
B. J. Garceau, ICI America Inc., 151 South Street, Stamford, Connecticut 06904
Max Goldfrank, Stein,Hall & Co., Inc. (Celanese), 605 Third Avenue, New York,
New York 10016
S. F. Goodheart, Levey Div. Cities Service Co., 630 Glendale—Milford Road,
Cincinnati, Ohio 45215
JO
Charles H. Goodman, The Dow Chemical Company, 2030 Dow Center, Midland,
L
Michigan 48640
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Francis tf. Greenough, Cryovac Division, W. E. Grace & Co., P. 0. Box 464, Duncan,
Sooth Carolina 29334
Taylor Hanavsn, E. 1. duPont de Nemours, Film Dept., 1007 Market Street,
Wilmington, Delaware 19898
G. Frederick Hanna, Marbon Division, Borg-Warner Corp., F. 0. Box 68, Washington,
West Virginia 26181
Jerome H. Heckman, SFZ General Counsel, 1150 17th Street, N.W., Washington, D.C. 2002
Michael Hirsch, B. F. Goodrich Chemical, 5100 Oak Tree Blvd. Cleveland, Ohio 44111
Karl A. Eochschwender, American Hoechst Corp., Soute 202-206 North, Somerville,
New Jersey 08876
John F. Jones, The Standard Oil Co. (Sohio), Midland Bldg., Cleveland, Ohio
Otto S. Kauder, Argus Chemical Corp., 633 Court St., Brooklyn, New York 11231
Peter P. Klemchuk, CIBA-GEIGY Corp., Ardsley, New York 10502
Robert H. Knust, Celanese Plastics Co., Morris Court, Sunnit, New Jersey 07901
Jack L. Laving, Eastman Chemical Products, Inc., Kingsport, Tennessee 37662
Clyde W. Leaf, BASF Wyandotte Corp., Biddle Avenue, Wyandotte, Michigan 48183
Jerome H. Ludwig, Synthetic Products Co., 1636 Wayside Road, Cleveland, Ohio 44112
Joel Markowitz, Dart Industries Inc., Chemical Group, W. 115 Century Road,
Paranus, New Jersey 07652
Peter Morison, Eastman Chemical Products Inc., Kingsport, Tennessee 37662
Peter M. Keokov, Keller and Heckman, 1150 17th Street, N.W., Washington, D. C. 20036
Donald V. Pugh, U.S. Industrial Chem. Co., ?. 0. Box 218, Tuscola, Illinois 61953
Lorence Rapoport, Olin Corp., P. 0. Box 200, Pisgah Forest, North Carolina 28768
George A. Richter, Rohm and Haas, Independence Mall West, Philadelphia,
Pennsylvania 19105
Robert £. Rutherford, Gulf Oil Corporation, 439 Seventh Ave.,Pittsburgh,
Pennsylvania 15230
A. Merrill Schnltzer, Phillips Petroleum Co. 356 Research Building 1, Bartlesville,
Oklahoma 74004
W. V. Sederlund, National Starch & Chemical Corp., 1700 West Front Street,
Plainfield, New Jersey 07063
Dwiffht M. Sheets, Shell Chemical Company, One Shell Plaza, P. O. Box 2463,
Houston, Iexas 77001
Matthew E. Smith, Owens- Illinois, 14th & AH Min sts., Toledo, Ohio 43606
Charles J. Spiegl, Continental Can Co., 7622 S. Racine Ave., Chicago, Illinois 60620
Don F. Thompson, Amoco Chemicals, Tech Center, Naperville, Illinois 60540
Judith A. Tins, Celanese Corporation, 522 5th Avenue, New York, New York 10036
Philip J. Vanderhorst, DuPont-Film Department, 1007 Market Street, Wilmington,
Delaware 19898
F. J. Vandermark, Northern Petrochemical Co., 2223 Dodge St., Omaha, Nebraska 68102
Willard M. Westveer, The Dow Chemical Co., 2040 Dow Center, Midland, Michigan 48640
George F. White, Jr., Reynolds Metals Co., 10th & Byrd Sts., Richmond, Virginia 2321S
.'■mbrose G. Whitney, W. R. Grace & Co., Reaeaxch Division, Clarksville, Maryland 2102*
Ronald M. Wilson, Jr., Emery Industries, Inc., 4900 Bate Ave., Cincinnati, Ohio 45231
L. W. Ziealak, Foster Grant Co., Inc., 289 N. Main Street, Leominster, Massachusetts
C. L. Condit, Secretary. SPI, 250 Park Avenue, New York, New York 10017

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Under the Chalmanahip of Bobert M. Miller, Hercules, Inc., a regular meeting
of the SPI Food, Drug and Cosnetic Packaging Materials Committee convened In
the Shore ham Hotel, Washington, D. C. at 9:20 a.m. Mr. Hiller contented on
the outstanding attendance, noting that there vere more present than the
Secretary expected.
Further, Mr. Miller mentioned that It had been some time since the Committee
conducted a so-called "closed" meeting since at the last few sessions, there
have been FDA people on the program, and at times others not part of the Com­
mittee. He asked those present to feel free, at any time, to pose questions
throughout Che day's meeting.
Referring to the detailed Agenda, Mr. Miller then asked for the usual selfintroductions.
Minutes of Last Meeting Approved
Indicating that the last meeting of the Committee was held at the Cosaodore
hotel. New York City, on June 3, 1971, Chairman Miller asked if there were
anv corrections or additions to the Minutes as developed and circulated by the
Sec rotary. In the absence of comments, he declared the Minutes approved as
circulated.
Preliminary Remarks by Mr. Miller
At this point Mr. Miller expressed pleasure that Charlie Stone, Eastman Chemical
Products, Inc., and Vice Chairman of the Comlttee, as well as Chairman of the
Lawyers' Advisory cosnlttee is reported to be coming along very nicely following
a prolonged illness, and more recently, major surgery. Mr. Miller announced
that Jack L. Lawing of Eastman Chemical Products, Inc. would represent Mr. Stone
at the day's session, and, at the appropriate time, would deliver the report
on the activities of the Lawyers' Advisory Subcommittee.
Commenta by Chairman Hiller on Activities and Scope of the SP1 Public Affairs
Council and European Developments
Chairman Miller then gave the following report, dealing with the SPI Public
Affairs Council and European developments:
Report of Chairman Miller
SPI PUBLIC AFFAIRS COUNCIL
"SPI has formed a new operating division known as the Public
Affairs Council. It formerly was designated as the Plastic/Packaging
Council and Plastics Council and was initiated as the single focal
point of the SPI environment program. It is now a division of SPI
and Hill have representation on the SPI board. A draft of by-laws
For the council bas been prepared and is ready for adoption. It is
composed of management representatives of many member companies and
has che following objectives:
a)

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Convince influential publics about the benefits
of plastics.

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b)

Convince our customers that not only do plastics
represent good, modern design and material solu­
tions, but also that plastics do not expose these
customers to public relations problems.

c)

Respond quickly and accurately to public criticism
of plastics.

d)

Counteract or repeal anti-plastics legislation.

e)

Demonstrate that the plastics industry has a
genuine and constructive concern for improving
our environment.

"To assist in reaching these objectives, the Council has obtained
the services of Hill and Knowl ton, one of the leading public rela­
tions firms. In addition, the Council has hired its initial legis­
lative representative.
"From its inception in mid-July to the end of 1971, the Council
operated on a budget of approximately $391,000. fledges totalled
approximately $340,000 and SP1 pledged $50,000 to make up the dif­
ference. The Public Affairs Council has a proposed 1972 budget of
$975,000. As of the middle of February, pledges have been received
in excess of $850,000 from 44 member companies. They hope to obtain
pledges of at least $1,000,000. If your company has not joined the
Council, please check and see that they know about its activities and
can became a member. This is a united plastics industry effort with
with we all should be concerned.
"Three current 'hot areas' of immediate concern to the SPI
Public Affairs Council are the states of Massachusetts, Vermont and
New York. Bills pending in Massachusetts concern taxes on nonreturnable and no deposit containers and perhaps some actual bans
on certain items. Vermont ha«t a bill to be passed momentarily which
stipulates a 1 mil/container tax on all separate closed containers
(bottles, jars, cans and cartons). We just have been informed that
this Vermont bill was not passed but was retuned to conmittee for
further consideration. New York has a non-returnable container tax
till before the legislature, as well as one to ban PVC. The SPI PAC
is actively engaged in following these actions.
"The Subcommittee on the Environment of the Senate Commerce
Conmittee just concluded hearings (held on March 6, 10 and 13) con­
cerning the environmental aspects (primarily of solid waste dis­
posal) of containers of all types, Ralph Harding- Executive Vice
President of SPI, made a statement to the subcommittee regarding the
environmental characteristics of plastic containers.
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"We do not want to take time to discuss the details of these
actions here, but if any of you is interested in then, ve suggest
you contact Mr. Sam Nuspliger at the SPI office.
INTERNATIONAL DEVELOPMENTS
"The Council of Europe is holding a second symposium on food
packaging in Home on March 23 and 24 es a follow-up on the 1971
symposium in the Netherlands, which I attended as a representative
of SPI and reported on at the June 3 meeting. This symposium is
being hosted by the Italian government, and, unfortunately, they
decided not to invite any delegates from the D. S. Apparently they
plan to continue discussion of 'global' migration and the philosophies
of policing and regulating food packaging materials. We will have
to receive our reports of their deliberations from our European
contacts.
"We have received word that the Dutch have come up with a new
approach to regulating packaging materials as an attempt to resolve
the differences between the French and Italian philosophy and that
of the Dutch and Germans so that uniform regulations can be estab­
lished. We cannot see that this new approach will be of much help
to us in our negotiations with FDA, but here Is the Dutch proposal
as we understand it:
"The old system was like that of Vest Germany in that positive
lists of recommended or approved additives were given for each
plastic or packaging material, with limitations on the quantity of
many. The limitations resulted from toxicological considerations,
self-limiting features or the amounts tested in each instance. This
meant an analytical method was required for each additive in each
plastic. The Dutch commission analyzed the list, deleting all
additives where the limitation was not based on toxicological con­
siderations and where the compounds did not give rise to toxicol­
ogical problems. This resulted in deletion of 75Z of the list.
For the remaining 25Z, it was decided to replace the maximum
concentration In the plastic or other food packaging material with
a maximum number of milligrams in food or a food simulating solvent.
This number, when converted to ppm's In food, should not exceed
the ADI (Acceptable Dally Intake) times 60. An assumption is
made that the daily food intake la 1 kg/day. Since 1 kg of food
is wrapped in an average of 6 sq. dm. of plastic, and the migra­
tion of plastics does noc exceed 10-12 mg per sq. dm, this calculates
to 60 mg/kg food or 60 ppm. This 60 ppm is an arbitrary number,
but it was concluded that if the migration (or extraction) of a
specific ingredient doea sot exceed the ADI times 60, it may be
used in any quantity with no limitations or analytical tests re­
quired. Since it was established that the maximum migration of

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a plastics component was 60 ppm, compounds with an ADI greater
than one will meet these criteria.
"The ADI times 60 has been designated as the Packaging ADI
(PADI). The ADI used for most of the calculations has been based on
the .results of 90-day animal feeding studies• If the migration
exceeds the PADI, the specific migration of the additive must be
determined, and a limitation for that ingredient will be in the
regulations. Thus, an analytical method is required for those
compounds. The PADI system supposedly incorporates the 'Frawley
proposal' to 0.05 ppm, but we have no details on that as yet.
Perhaps we will know more after the Rome symposium.
"The Dutch proposal was developed to attempt to resolve the
differences noted at the Hoordvijk symposium in 1971 between the
Dutch and German approach versus that of the French and Italians.
The former had positive lists with provisions for petitioning for
new additives, while the French ««d Italians assumed that plastic
packaging materials would offer no hazard to public health if the
gross migration or extraction is less than 50-60 ppm when using a
procedure similar to our end-use extraction test. The French and
Italians desired to U9e this as a means of policing the law. The
new Dutch PADI system supposedly combines the tiro approaches, which
ssay satisfy the Council of Europe.
"The second item concerning international developments is the
notice of a forthcoming seminar on the 'Migration of Additives
from Plastics and Their Determination in Fat Simulants', sponsored
by Onilever in Hamburg, West Germany."*J
ralxr.ring Mr. Miller's report on European activities, Norman Bornstein, Cryovac
Division, W. R. Grace & Company, suggested that in one manner or another it
would be quite desirable to assemble a bibliography of foreign papers on
extraction studies or methods which have either been delivered, or are to be
delivered at some time in the future. Mr. Miller said that this could very
well be considered by the Technical Information Subcommittee, and asked that
the Subcommittee Chairman report on such matters from time to time to the
extenc that is possible to assemble such a list.
In closing his report, Mr. Miller noted that the international situation as
regards the interests of the Committee's members are becoming more and more
important and that, therefore, there is every reason for an adequate liaison
to be maintained with the various countries abroad, if, for no other reason, than
to try to steer them towards a better regulatory system than ours.
Details are contained in the attached announcement. Appendix A.

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nomination and Election of Officers

Chairman Miller reminded those present that, some time ago, he had appointed
a Nominating Committee composed of Messrs. Matthew E. Smith, Chairman, OwensIllinois; and members George W. Ingle, Monsanto Company; and Max Goldfrank,
Stein, Hall & Co., Inc; asking that they propose a slate of proposed officers
as well ;s Steering Conmlttee members-at-large for the period beginning June 1,
1972 to lune 1, 1974.
He then called upon Matt Smith to give the Nominating Committee report.
Mr. Smith named the following proposed officers: General Chairman Karl A.
hochsciiwender, American Hoechst Corporation; and Vice Chairman, Willard M.
Uestveer, the Dow Chemical Company. The appointment of the following members
to the Steering Conmlttee, Karl A. Hochsciiwender, Chairman, American Hoechst
Corporation; W. B. Ackart, Union Carbide Corp.; Paul F. Cundy, American Can
Company; Taylor W. Ranavan, E. I. duPont de Nemours & Co., Inc.; Robert M.
Miller, Hercules, Inc.; Ceorge A. Richter, Jr., Rohm & Haas Company; and
Willard
Westveer, The Dow Chemical Company; was also recommended.
Chairman Miller asked If there were further nominations, and in the absence
of :tnv, Mr. Smith moved that the nominations be closed and that the Secretary
case d unanimous ballot for the slate as proposed. The motion was seconded
and carried unanimously.
At thus point. Chairman Miller expressed deep appreciation for the fine cooperatloi. he has had from both the Steering Conmlttee and the SPI office during
hia t'Hui.-t? of office, and expressed hope that some accomplishments were made
during hi* Chairmanship.
Report i,i cPl General Counsel
Chatman Miller next Introduced Jerome H. Heckman, Keller and Heckman, and
General (..lunsel for £l‘I, to deliver his regular report on various regulatory
•ictlviLiis relating to the Interests of the Industry.
[Please i.nte: Attached hereto is a reproduction of Mr. Heckman's complete
prcHcntat ion at the day's session, including various attachments in the form of
appendict. h mentioned by him. J
At i
>-.r.sec, Mr. Heckman asked that those present Interrupt him at any time
fit.coM id .y have questions to pose or, on the other hand, at any point where
for null at:ion wis requested to be taken at the day's session regarding any one
c>£ more . f the. items he discussed.
In .1 J..scu«=- mg the status of the USDA proposed amendments to meat inspection
regul.iUuni, Ur. Heckman reminded those present that attached to his report
* *»oi- .a tn -fount to these Minutes) was MPI Notice 69 while available for the

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- 8 first tine at the day's meeting of the Steering Connietee was a document labeled
MPI Notice 74.
It vas requested by Hr. Heckman at the day's session that the Secretary place
the MPI 74 Notice in the Minutes. It follows:
"UNTIED STATES DEPARTMENT OF AGRICULTURE
Consumer and Marketing Service
Meat and Poultry Inspection Program
Washington, D. C. 20250
"INFORMATION FOR:

MPI NOTICE 74

All MPI Personnel, Owners, and Operators
of Official Establishments, and State
Officials

Section 302.3 in the Manual of Meat Inspection Procedures
and Section 81.95 of the Poultry Inspector's Handbook.
"The above sections are being revised to permit the use of con­
tinuing letters of FDA guaranty.
"Please advise those who inquire, that such letters will be per­
mitted whenever letters of FDA guaranty pertain in the instruc­
tion to be Implemented April 1, 1972.
"An example follows:
'The articles listed herein comprising each shipment
or other delivery hereafter made by (name of person
or coaipany giving guaranty) to, or on the order of
(name and address of person or company to wham the
guaranty is given) is hereby guaranteed as of the
date of such shipment or delivery, to be, on such
date, not adulterated or misbranded within the
meaning of the Federal Food, Drug and Cosmetic Act.'
(Signature of person with responsible
position in supplying f irm—address)

(si
Fred J. Fullerton, Director
Field Operations Division"

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9
There was a great deal of discussion at the day's session relating to Hr.
Heckman's report on the negative-type publicity which has appeared on the use
of phthalate plasticizers ever since the announcement of Dr. Rubin's findings
on the PVC blood bags problem. Especially helpful in the course of this dis­
cussion was a report given by Peter Morison of Eastman Chemical Products, Inc.
relative.to a recent meeting of a special MCA Coanittee called to discuss the
phthalates problem. Mr. Morlson reported as follows:
Manufacturing Chemists Association Technical
Meeting on Phthalates - February 24. 1972
"Thirty-three member companies of MCA most intimately affected
convened in Washington, D. C. on February 24, 1972 to discuss the
significance of publicity on phthalate plasticizers used in bio­
medical applications, particularly blood bags and medical tubing.
"It was agreed that some toxicological data on ingestion of
phthalates has been published and substantially more information of
value is believed to exist in company files. It would be helpful
to pool existing unpublished data and appraise its applicability
to the current problem.
"It was noted that a test program representing use of plasticized
-VC in sensitive applications is under way at Stanford Research
Institute and supported by representatives of industry. Results of
this program are not expected to be available for some months.
"At the meeting, representatives of eight MCA member companies
volunteered to create an Ad Hoc Planning Group on Phthalate
Studies for the purpose of developing a program for further con­
sideration which may include a meeting with Drs. Rubin (Johns Hopkins),
Autian (University of Tennessee), and Guess (University of Texas),
and other researchers in this field.
"The Ad Hoc Committee is composed of representatives of the
following companies:
Baxter Laboratories
Borden Chemical Co.
Eastman Kodak Co.
Enjay Chemical Co.
W. R. Grace & Co.
Monsanto Company
Union Carbide Corp.
USS Chemicals

(Dr. Gesler)
(Dr. Cummin)
(Dr. Raleigh)
(Dr. Livingston)
(Mr. Magram)
(Mr. Graham)*
(To be named)
(Dr. Mackay)

♦Temporary Chairman
"MCA Will serve only as a vehicle reflecting the position of

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its member companies. MCA sponsorship of any program must be ap­
proved in advance by its board of Directors and funded by part­
icipating member companies."
Thereafter, Mr. Miller pointed out that the Steering Committee, in a meeting
the previous evening, had expressed great concern about the phthalates problem
and believes this whole matter should be brought to the special attention of
the SPI Board of Directors. In this regard. Bill Westveer, a member of the
Steering Committee, first proposed a motion whereby Che full Committee would
approve approaching the SPI Board of Directors to call a meeting of PVC and
plasticizer producers in order to ascertain whether the time has coma for a
position paper to be prepared on the use of these materials if, for nothing
else, than to protect the market where these materials are known to be ad­
vantageous and have favorable characteristics.
There was then a great deal of discussion about the matter, one question
raised being whether the action proposed by the Steering Coonittee might result
in the preparation of a position paper by SPI which could duplicate or con­
flict with the present work of MCA. in this area. It was noted that at a
recent special MCA meeting it was decided that it was premature from a tech­
nical point of view to prepare such a paper. In any case, it was reported
that the MCA Committee is considering conducting a literature search, and has
asked companies represented on the study committee of MCA to make a search of
their own files in order to provide more input on Che entire matter. The
MCA group apparently has also asked various toxicologists to review the works
cf such researchers as Dr. Rubin and others; determine then, what further in­
formation is required; and, finally, recommend what future work should be
undertaken, if any.
Mr. SornBtein urged that it would certainly seem more desirable to effect
liaison with the MCA Committee, rather than duplicate its activities.
Chairman Miller and others agreed that Mr. Bernstein's points were very well
taken. He noted that, in the final analysis, the real intent of the motion
proposed by the Steering Committee was to make certain the seriousness of the
plasticizers matter is brought to the attention of the SPI Board of Directors
since it is recognized that the SPI represents a segment of industry, prin­
cipally fabricators and convertors, which are not necessarily represented in
MCA activities.

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It was further noted that this Committee does believe the matter requires SPI
Board of Direceors consideration because of its marketing and public relations
overtones. The present constitution of the SPI Food, Drug and Cosmetic Pack­
aging Materials Committee would not appear to be of the type which would assure
completely appropriate activity on the phthalates matter for this reason.
Mr. Heckman noted that perhaps an entirely new Committee should be considered
by SPI, and should include marketing people who recognize the problems as
they relate to selling the products involved. Furthermore, Mr. Heckman said,
call it a position paper or not, what actually is needed is a kind of response

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- 11 from the Society to answer inquiries which are beginning to be made at various
levels, including ones he is receiving from Capitol Hill.
Finally, after much dlsucssion on the composition of a motion which would
direct the whole problem in one form or another to the attention of the SPI
Board of .Directors, the following motion was carried with one negative vote:
"The SFI Food, Drug and Cosmetic Packaging Materials Committee
orders its Chairman to suggest to the SPI Board of Directors
that it consider calling a meeting of PVC and plasticizer pro­
ducers, as well as users, in order to ascertain what course of
action should best be taken to clarify the present phthalate
plasticizer situation for the Industry, and when necessary, for
inquirers on the subject."
Chairman Miller agreed that, for the present at least, there should be liaison
between SPI and the MCA Caonlttee on the matter of phthalates, PVC, etc. At
this point he asked Norm Bomsteln to accept this liaison position and Mr.
Bomstein agreed to do so.
At another point in his presentation, Mr. Heckman asked for direction as to
whether it is feasible and possible for a small amount of barium compound to
be added to plastics generally so that x-rays could more readily detect a
swallowed substance.
In dealing with this matter in detail in his report, Mr; Heckman also dis­
cussed at the day's meeting the various attachments to his presentation to
illustrate that a Dr. William P. Slover, Hartford Radiology Group, Hartford,
Connecticut, points out that as a radiologist he is called upon from time to
time to find a foreign body which a child has ingested or inhaled, and that
he wonders, in the case of plastics, whether it would be possible to im­
pregnate an object with barium; which is readily detected on an x-ray.
Essentially, Mr. Heckman asked for general guidance at the day's session as
to how he might answer this inquiry.
Several opinions were offered, such as the fact that a study would have to
be nmde as to how much barium can safely be added to the various molding com­
pounds as they relate to compatibility for one thing, and how such compounding
would affect properties such as impact. It was suggested during the dis­
cussion that if the designation "barium compound" could be avoided, thus
allowing for other materials of this nature to be used, it might be desirable
and that care must be taken to assure that the system is not construed as a
diagnostic drug.
It was revealed at the day's meeting that the barium compounds have been intro­
duced effectively in polystyrene.

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By way of stunary, Mr. Heckman said that it would appear that Introducing a
barium system into plastics does not pose a major problem but, on the other
hand, it is not without its problems which would have to be investigated and
considered in the context of specific applications. On the other hand, Mr.
Heckman noted that this whole matter is also being taken up with the toy
manufacturers by FDA in order to resolve any problems which might exist.
During a discussion of the PCB problem, it was noted that in the March 13
edition of Food Chemical News there was an article on the polychlorinated
biphenyls.
Speaking on the subject of updated methodology to provide PCB-free "certificates"
to customers, Mr. Heckman pointed out that W. B. Papageorge of Monsanto has
supplied such a method to many inquirers. The question arose at the day's
meeting, however, as to whether Mr. Papageorge has updated his procedure since
last summer, or whether it is otherwise adequate for plastics. Dan Dialer,
Keller and Heckman, said that his information is recent and that apparently
Mr. Papageorge's test method does not include recent updating but, on the
other hand, he was not too certain of this.
The question Chen arose as to whether the Committee should organize a task
force to either develop procedures or at least determine whether more specific
procedures are actually needed at this time. For instance, it was opined
that the paper people, more involved apparently with this problem, may be
developing all of the type methodology that is needed, thus making it un­
necessary for the SP1 Committee to get Involved at all. Also brought out was
the fact that there is in ASTM a Committee known as F-2 dealing with flexible
r-AtarJ.als that has considered this matter to some extent. Finally it was
decided that Mr. Miller would assign this whole problem to tbe Technical In­
formation Subcommittee for full investigation and, if necessary, test method
development.
At this point, Mr. Norm Bornstein, V. R. Grace & Company, volunteered to work
on the project, and Mr. Westveer, Chairman of the Technical Information Sub­
committee, asked chat others advise him should they care to help on the PCB
matter. Watt Ackart also noted that a Union Carbide paper on the subject
would appear in the March issue of Modern Packaging Magazine.
At the end of his discussion, Mr. Heckman dealt at some length with devices
legislation, and, in this connection, asked the Committee whether it wished to
take a position on the FDA sponsored bill on devices, (see Mr. Heckman's
attached report) in view of the fact that there may soon be a time when the
preparation o£ testimony is called for either for tbe legislation, against it,
rcr it in part, against it in part, etc.
On a more specific point, Mr. Heckman said that, as his report indicates, he
would like to have the Comnlttee's instructions about the invitation received
from tbe Food and Drug Administration to supply It with information about an
SPI Subcommittee which can be called upon to work with the Division of Standards
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13 of the Office of Medical Devices with a view towards development of future
device standards, where needed. Mr. Heckman felt that a permanent Sub­
committee on "medical devices" is quite in order at this time.
Taylor Hanavan, E. I. duPont de Nemours & Co., Inc. moved that the Chairman
appoint and organize a standing Subcommittee on Devices. The motion was
seconded and carried unanimously.
Chairman Miller then appointed George Richter, Rohm & Haas Company as Chairman,
and the following Individuals volunteered to serve on the Subcommittee:
Philip J. Vandezhorst, E. I. duPont de Nemours & Co., Inc. (Film Department);
Ernest M. Dixon, Celanese Corporation; E. J. Vandermark, Northern Petrochemical
Company; Peter Morison, Eastman Chemical Products; Leo Ziemlak, Foster-Grant;
and, finally, Daniel S. Dixler, Keller and Heckman, who will serve as Subcommittee
Secretary.
Reports on Liaison with Other Organizations
Mr. Miller then called for the regular reports on activities of other organiza­
tions relating to the interests of the Committee.
Pharmaceutical Manufacturers Association
and U. S. Pharmacopeia—Drug
Packaging Materials Subcommittee
W. B. Ackart, Union Carbide Corporation gave the following report:
"The June 3, 1971 report of this Subcommittee Included the
details of its expanded sphere of interest, name change, and person­
nel changes which have taken place. We also reported at that time
that our report on 'Methodology for Testing Polyolefin Containers
for Tablets, Capsules, Oral Powders, and Granules' had been accepted
by the Quality Control section of the Pharmaceutical Manufacturers
Association who in turn had submitted it to the U. S. Pharmacopeia
for publication. Some uncertainty regarding which draft had reached
the PMA was satisfactorily resolved through a meeting with the
appropriate PMA people.
"Last November, we vere contacted by Dr. Jules Pinsky, a charter
member of this Subcommittee who is now associated with The Mearl
Corporation. Dr. Pinsky told us that the draft of the Methodology
had come from Mr. John Ruggiero of the PMA staff to Mr. George
Schneller, Chairman of the U. S. Pharmacopeia Advisory Panel on
Containers and Packaging who in turn referred it to Jules as chair­
man of their Task Group on Plastic Containers.
"Dr. Pinsky suggested some modifications in the procedure
which were circulated to this Committee and shortly thereafter a

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telephone conference call was arranged between Or. Pinsky and three
of us at which agreement was reached regarding the changes. These
included (1) the complete removal of the biological test, (2) a
narrowing of the density limits from 0.020 g per cc to 0.005 g per
cc where one polyolefin resin may be substituted for another in a
packaging situation, and (3) a change in the form of the formula
for water vapor permeability.
"Dr. Pinsky has circulated the revised method to members of
his task force and has received no adverse comments. The parent
Advisory Panel was also circulated and Dr. Pinsky feels that the
Methodology can be cleared for publication this yesr. When this
is accomplished, it is our intent to approach Food and Drug to seek
changes in their regulations to permit the Interchangeability in
dry drug packaging of a polyolefin resin with any other manufacturer's
generic counterpart where the basic specifications are the same as
determined by the published methodology.”
In closing his report, Mr. Ackart said that he had just received some proposed
definitions and procedures for a forthcoming edition of the U. S. Pharmacopeia.
He said that he would circulate this Information to members of his task force.
Manufacturers' Chemists Association
Taylor W. Hanavan, E. I. duPont de Nemours & Co., Inc., reporting on MCA's Food,
Drug and Cosmetics Chemical Committee activities, first advised that he con­
siders it one major achievement of the MCA group that George W. Ingle, Monsanto
Company, was elected Vice Chairman so that he will soon be the incoming
Chairman.
Mr. Hanavan next reported that Dr. Dodgen of National Academy of Sciences,
who is working on the FDA GBAS survey and Food Chemicals Code at has recently
been sitting in on discussions with the MCA Committee so that the GBAS survey
form now being circulated embodies the MCA suggestions and comments. Con­
tinuing, Mr. Hanavan noted that the MCA Committee had provided testimony on
the Toxic Substances Control Act of 1971; and has issued 40,000 copies of a
new booklet entitled "Food Additives—What they Are and How They are Used."
In conclusion, Mr. Hanavan made mention of the recent meeting of the Society
of Toxicology and the symposium on mutagenicity studies since this has been
the subject of FDA-MCA controversy, just as such work was viewed critically at
the Toxicologists' meeting the previous week.
Can Manufacturers' Institute
Charles J. Spiegel, Continental Can Company, Inc. indicated there was nothing
new to report in this area.

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SPI Market Development Committee of
The Plastic Bottle Division
Matthew £. Smith, Owens-Illinois, presented the following report:
. "I wish to point out to some of you that the Food and Drug
Bottling Committee of the Plastic Bottle Division is now called
the Market Development Committee of the Plastic Bottle Division.
This change in name was made to reflect more closely the objectives
and plans of our Committee.
"As previously mentioned, members of the Bottle group worked
closely with Jerry to help prepare SPI's report to AIFD which they
used very favorably in writing their initial Environmental Impact
Statement. For obvious reasons, we are following this very closely.
"At our last meeting on February 29 in New York, we discussed
the possibility of holding another seminar late in '72 or early in
'73. The details are not finalized as yet."
American Paper Institute
Chairman Miller called upon Paul Cundy, American Can Company to report on activities
of the American Paper Institute knowing of the concern which the API has presently
as regards the PCB problem.
Dr. Cundy reported that API has sponsored research work now being conducted at
Hazelton Laboratories to define the scope and significance of the "PCB in paper"
problem. The research attempts to answer two questions: an analysis of a
broad spectrum of paper, paperboard, and pulp to determine how much PCB may
actually be found in such products; and migration tests using paper packaging
material with known added quantities of PCB to determine exactly how much PCB
could be expected to migrate into foods from paper which contained PCB. In
connection with this latter investigation, three different barrier materials
are also being evaluated. These are polyethylene, saran coated paper and
glassine.
Although the study is not yet completed. Dr. Cundy reported, the 30 day results
show that migration even from heavily "spiked" paper is considerably less than
was originally believed to be true. When the study is completed, the API hopes
that the results will provide firm scientific background to justify limiting
the PCB content in food rather than in containers or other packaging materials.
Report of Technical Information Subco™*'*ttee
Chairman Miller called upon Willard M. Westveer, The Dow Chemical Company and
Chairman of the Technical Information Subcommittee to make his usual report.

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In the first place, Hr. Vestveer referred Co the PCB problem, indicating his
Subcommittee would undertake a study of this matter; attempt to determine
the relevance and extent of what other groups are doing; gather all of this
information; and then make a recosmendation on how the Technical Information
Subcommittee should proceed. He therefore urged that all present send him any
information they have on these matters.
Mr. Westveer then turned the Committee's attention to a listing of recently
promulgated food additive regulations, and related regulatory actions. In so
doing, he highlighted some of the items in the listing which he felt should
be brought to the Committee's attention.
[Please note, attached hereto as an exhibit, dated March 13, 1972, is the
regular listing of "Recently Issued Food Additive Regulations"].
Report of Lawyers' Advisory Committee
On behalf of H. C. Stone, Chairman of the Lawyers' Advisory Subcommittee, Jack
L. Laving of that company presented a detailed report. [Plsaae note: This
report dated March IS, 1972 is attached as an exhibit]
In concluding his report, Mr. Laving asked those present to join him in wishing
Charlie Stone a quick recovery.
At this point, before the subject of new business was introduced, the matter
of the Toxic Substances Act was discussed. William Allen, American Cyanimid
Company noted that the Toxic Substances Control Act could be a "Frankenstein
sonster" although it is generally understood that passage of the legislation
in this Session of Congress is unlikely. During the subsequent discussion, it
was noted that some customers are asking for impossible guarantees and infor­
mation about the more than 12,000 substances on the first Government list of
toxic substances but this is because of erroneous impressions of Occupational
Safety and Health Ace responsibilities, not because the Toxic Substances Act
has been passed.
New Business

Under the subject New Business, Karl Hochschwender, incoming General Chairman
of the Committee, cited two Items which he felt would be of Interest. One
deals with those importing products subject to FDA procedures and regulations.
He noted special briefings on this subject are being held in view of the fact
that, evidently, FDA is stepping up its inspection program and there is to be
more careful screening of certain products under its jurisdiction as they come
across the USA borders. Dr. Hochschwender indicated he would be attending one
of the briefings to be held on March 16 and would be glad to give a report cn
the same to the Committee at its next meeting, or perhaps by means of a
written report which could be circulated sooner.

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Secondly, Dr. Hochschwender said that the U. S. Tariff Comnrtsalon
Is Investigating on behalf of the Senate Finance Committee non-tariff barriers
and that originally the deadline for comments was March 16 but that he has
learned that the Tariff Commission has extended this deadline date to April
11. Essentially, the Tariff Commission is looking for Information from those
who have encountered difficulties in this area so anyone with such Information
should consider supplying it to the Tariff Commission which will treat it
confidentially. The type restrictions referred to by Dr. Hochschwender are
those such as unreasonable food additive regulations and similar official
policies of foreign governments that hinder the international exchange of
goods.
William Allen, American Cynamid Company, again brought up the subject of the
Occupational Safety and Health Administration and the Act that it administers
indicating that his company is beginning to be deluged with requests for infor­
mation from customers for TahoUwg information, especially on how much is
used of a substance that is "so-called 'toxic'". Mr. Heckman acquainted the
Committee with the fact that SPI is strongly involved in this whole matter of
OSHA through its Safety and Loss Prevention Committee headed up by a staff man,
Jerry Carroll, at the SPI office in New York. Mr. Carroll and his Committee
are beginning to issue regular bulletins outlining the Impact of OSHA on the
plastics industry and most certainly Mr. Carroll or Mr. Shaye (in Mr. Heckman’s
office) would be receptive to hearing from anyone encountering problems of
a nature where some assistance or clarification can be given.
Next Meeting
Mr. Miller announced that the time and site of the next overall meeting of the
Committee will be left up to the Steering Committee and the new officers, as
is customary.
Zhzit being no further business, the meeting was adjourned at 2:45 p.m.

Respectfully submitted.

Charles L. Condit, Secretary

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