-4Under the direction of General Chairman, Robert M. Miller, Hercules,
Inc., an overall meeting of the SPI Food, Drug and Cosmetic Packaging
Materials Committee convened in the Commodore Hotel, New York City, on
Thursday, June 3, at 9:15 A. M.
Following the detailed Agenda which had been circulated prior to the
day's business session, Mr. Miller asked for the usual self-introduc­
tions .
Minutes of Last Meeting Approved
Referring to previously circulated Minutes of the January 13, 1971,
meeting, Mr. Miller asked for corrections or additions; there being none,
he declared them approved as distributed.
Preliminary Remarks by Mr. Miller
In his preliminary remarks, Mr. Miller referred to the Second Annual
Meeting of Voting Representatives of SPI held in Boston, Massachusetts,
just the previous week; and then spoke about the SPl's new dues system
which becomes effective on June 1, 1971 the beginning of the Society's
fiscal year. He pointed out that the old dues system, in which companies
paid dues on a self-assessment basis, broke down. Therefore, the Board
of Directors decided on a new dues system which simply calls for a com­
pany to divulge, on a confidential basis, to the SPI dues auditor. Young &
Company, a company's full net total sales related to the plastics indus­
try.
It was determined at last week's meeting of the Board of Directors
that the assessment to each company would be 35 cents per $1,000, with the
Board establishing that for the 1971-72 fiscal year, the minimum dues
would be $250 and the maximum dues would be $16,500.
Of the approximately 1,200 corporate members within the United States
who received the sales information survey, there are approximately 400
companies yet to be heard from. In this regard, Mr. Miller said that
every attempt is being made by those members of the Board of Directors
and members of the Staff at SPI to make personal contacts with the
companies from whom no sales information survey has been received.
At yesterday's meeting of the Steering Committee, Mr. Miller concluded,
it was determined that before the next meeting of the overall SPI Food,
Drug and Cosmetic Packaging Materials Committee, the Secretary would be
asked to cull the roster in order to remove the names of individuals from
companies which are not members of the SPI by the time of the Fall meeting
of the Committee.
Report of SPI General Counsel
Mr. Miller at this point in the meeting introduced Jerome H. Heckman,
Keller and Heckman, and SPI General Counsel, who delivered the following
report:

ASI-PR 0001114

►

-5Report of SPI General Counsel
"In some ways it's probably good to be meeting here in New
York again after holding our last few sessions in the city of
empty promises, Les Ramsey and Alan Spiher, A great deal and
very little has happened since our January session where most
of you were with us to hear our regular reports, and some real
pearls from a good sprinkling of officials of that most ther­
moplastic body in Washington, the Food and Drug Administration.
It gives, it can be heated, beaten, and reground, but it al­
ways seems to retain its unbelievable shape,
"Before going into a little more detail, and meeting my
obligations under the Agenda, I would like to make a few brief
announcements.
"Firstly, I'd like to advise you that my law firm and I
have faced up to the fact that it may well be that people who
are well versed in chemistry and toxicology can be of real
help to us on a much more direct basis. That is why you
heard Dan Dixler introduce himself this morning as with Keller
and Heckman. Dan is now on our staff and is working closely
with me on Food and Drug Administration matters.
"Next, I do hope that the next stop on your personal road­
show will be the SPI-FDA Seminar which is now planned for June IdMost of you have received notices, I think, about the Seminar,
and Charlie Condit has already received somewhere in the neigh­
borhood of fifty reservations. If you haven’t sent a reservation
in yet, and are anxious to attend, please do so promptly be­
cause we may have to cut the attendance list off soon. We
are planning to have the session transcribed by court reporters—
much like the National Conference on Indirect Food Additives
was recorded—and the transcripts will be available in due
course. They will probably be sold by SPI for $25 which is the
cost of the registration fee for the Seminar. Thus, there is
no bargain in staying away and not being there will deprive
you of an excellent opportunity to ask your questions.
"The other point I should make clear is that in many ways,
this is an FDA show so we are experiencing delay in getting a
firmed up Agenda or program from the agency. We do know now
who the principal speakers are going to be. They will include
A1 Holtz, on the analytical chemistry side, Joe McLaughlin on
toxicology, and either Dr. Haenni or Dr. Howard, who have in
the past been responsible primarily for matters relating to
polynuclear aromatics type of testing.
Lou Buckley or A1
Rothschild of Petitions Control will also talk, and Tom
Brown is expected to be on hand. The session will be moderated

ASI~PR 0001

115

-6
by General Delmore, whom most of you have met.
"The FDAers know that what we expect to get out of the
Seminar is a better idea of what they expect to see in indirect
additive petitions. Thus, the papers are supposed to set
the stage for questions that any of you might have on how you
can improve your petitions. We expect to be able to use some
of that information ourselves for any number of reasons, and
we think that the transcript might prove to be a valuable thing
to have in the future. It will not be totally definitive be­
cause they change the ground rules every other day, but it
should be helpful.
It will at least give us a basing point
to start telling you where the changes are taking place.
"The next announcement is one I have been asked to make
by the Polytechnic Institute of Brooklyn which is having a
two-day seminar on June 24 and June 25 at the Institute,
333 Jay Street in Brooklyn, New York. The title of the
Seminar is 'Packaging with Plastics.'
I promised Dr. Bruins
at the Institute that I would pass out the Seminar announce­
ments and let you know that I am on the program to conduct
a question and answer session on FDA problems.
"Finally, and here i'll ask you to forgive what might
appear to be a lack of modesty, I want to mention to you that,
at the request of Modern Plastics Magazine, and under instruc­
tions from Ralph Harding, I'm going to be writing a monthly
column for Modern Plastics on legal topics of interest. The
main reason I am noting the fact here is that, in the first
column which will presumably appear in the July issue.
I
devoted at least half the column to a discussion of this whole
matter of the use of the phrase, 'FDA approved,' and when it's
improper, which is 90% of the time. The column also discusses
the kind of requests you receive on whether or not a material
is cleared under the Toy Safety Act, and other nebulous type
FDA enabling acts. The point is that this first column might
be helpful to you in educating some of your sales people, and
even some of your customers.
"Now we can get down to the 'nitty-gritty' of the Report
called for by the Agenda. At the request of Charlie Condit,
I'm going to background the first item on the Agenda designated
'Status of Continuing Action to Effect Action on the Ramsey
Proposal,' to make certain that everyone is 'in the picture'
on the entire subject.
"The way we look at the situation, it all started in 1966
at that famous or infamous American Chemical Society Symposium.

ASI-PR 0001116

-7A number of us appeared there and it was then that Jack Frawley
of Hercules first put forth what has come to be known as the
'Frawley Proposal.'
In general, at that time we severely
criticized the way the Food and Drug Administration was hand­
ling its responsibilities under the Food Additives Amendment
of 1958. In fact, the title of my paper at that meeting was
'It's Time fora.Change in the Law.’
"There were some FDA people at the ACS meeting, one of whom
promptly transferred to the Federal Trade Commission, our good
friend Mr. Fred Cassidy.
It's very hard to catalyze FDA into
anything except inaction, however, so the papers given were
spread on the winds. FDA was aware of them and there was
talk in the halls about how they were considering things
like the Frawley Proposal but we really weren't going very
far on this basis.
"In due course, however, a congressman, Congressman
Dingell of Michigan, became Interested enough to ask Dr.
Goddard, then FDA Commissioner, a couple of questions about
indirect additives at an unrelated hearing on drugs. The
questions were rather searching, primarily because they were
suggested to Mr. Dingell by people somewhat versed in pack­
aging problems, and FDA had quite a bit of difficulty with
them.
"Instead of answering all of them directly, the agency
decided that maybe the best way to satisfy Mr. Dingell tempor­
arily would be to call a National Conference on Indirect Food
Additives, which they did. FDA gave us in industry, as I re­
call, a month or a month and a half's notice, and asked for
papers.
I think they were a little surprised when industry
got together and did quite a job. And when I say industry,
I don't just mean the plastics industry. We all put together
an inter-industry group, coordinated our ideas, and set forth
quite an array of recommendations at the National Conference
on Indirect Food Additives.
"Incidentally, FDA had promised Congressman Dingell,
and there is a statement of record in the official trans­
cript of the National Conference proceedings that Food and
Drug would report to Congress in about sixty days on some
definite actions that it could take to improve its activities
in this area. That was February, 1968. The promised FDA
report to Mr. Dingell has yet to be filed, as far as we know.
You see, we're not the only ones to get the promises, promises
routine.

ASI-PR 0001117

-8"No action took place after that Conference that you
could call tangible—despite all sorts of efforts to bring
about action--until May of 1969 when Mr. Ramsey wrote to us
and others in industry. He happened to sign the letter so
the proposal he sent along has been called the 'Ramsey
proposal' ever since although I believe the 'Ramsey
proposal' was something that was prepared by the FDA
staff as a group effort.
In any case, it's easier to
give tags to such things, so we've called it the Ramsey
proposal ever since.
"The Ramsey letter was sent to us on May 6, 1969, and
simultaneously to representatives of all of the groups the
agency could identify as having an interest in this subject.
In his letter Mr. Ramsey characterized what they were sending
us as: '...the attached discussion draft Notice of Proposed
Rulemaking that we have under consideration as a first response
to comments received after the February 13-14, 1968, Confer­
ence on Indirect Food Additives.' That proposal was the one
wherein FDA suggested changes in the so-called Good Manufacturing
Practices Regulation, Section 121.2500, which would eliminate
the necessity for filing food additive petitions in situations
where you were dealing with dry foods, adhesives, repeated use
food contact surface items, and components of defoaming agents.
I think it Is fair to say that this much of the proposal was
reasonably satisfactory to everybody. The one controversial
concept included in the proposal was a plan whereby it would
be ruled unnecessary to file a food additive petition if a
substance was to be a component of a food contact article,
but would contribute no more than 0.05 parts per million to
the contacted food as determined by analysis of the food, by
appropriate extraction studies, or by calculation assuming
100% migration.
'Ve reviewed that proposal in good faith and brought
our Inter-Industry Committee together to discuss it.
In
due course, we reported a joint position to FDA in an August
29, 1969, letter and met with the FDA staff on September 3,
1969. And again I remind you that everybody really was in
agreement on. everything except the 0.05 ppm question. We
wanted the level to be raised to 0.5 ppm, and they insisted
it be left at 0.05.
"After the September 3 meeting we were told the FDA
Staff would consider what we said, and come back to us.
There then ensued another period of 'no word' during which
there was no FDA action at all despite the fact that we in­
vited Mr. Ramsey to our meetings at least twice to tell us

ASI-PR 0001118

-9what was happening. We also suggested to him on several
occasions, both informally and formally that if the 0.05
ppm or 0.5 ppm problem was too much of a difficulty, why
not go forward with the rest of the proposal. We could thus
make one small step forward. Nevertheless, nothing happened
in this respect.
"The only Intervening act that was helpful was that
Tom Brown came in to head up the FDA Office of Compliance
in the Bureau of Foods and we were able to elicit from him
the so-called 'Tom Brown letter' that I think most of you
are familiar with. This is the one that, after ten long
years of doubt, reaffirmed the Statute and said that you
really could say that something was not a food additive if
it may not reasonably be expected to migrate to foods.
That might seem like nothing too significant to some of
you, but the Tom Brown letter of August 21, 1970, has been
extremely helpful to us, and, I believe, to some of you in
assuring your customers that you do not have a food additive
problem in certain circumstances.
By the way, that letter
was reviewed by Billy Goodrich, who has just officialy
announced his retirement from the Food and Drug Adminis­
tration.
"Aside from these collateral developments, which did not
involve Mr. Ramsey or the other members of the FDA Staff
directly, nothing really took place on the Ramsey proposal
until our January 13, 1971 meeting where many of you were
witnesses to some promises made by the Food and Drug Admin­
istration Staff. One promise was that we would have a
Seminar, and this promise is being kept, as you heard
earlier.
"The most important promise was one that Tom Brown
more or less pushed his people into, as you could tell if
you were at the meeting, to have a session with us wherein
'we should be able to settle something about the Ramsey
proposal in two or three weeks.'
1 hope most of you remem­
ber Tom Brown said that, and I'm glad it was said in an open
meeting.
It was said in an open meeting, and we then set
about promptly conducting the clearance program we had to
conduct because in this case we were working with all of
the industries—we couldn't just do this by ourselves. We
had to get them to agree to a delegation to meet with FDA.
It took us from January 13 'til about the end of the month
to go about the clearance procedure, and we met with the
FDA Staff on February 3. Thus, I don't think we were de­
linquent in any way in going forward as proposed.

ASI-PR 0001119

-10"At the meeting with the FDA Staff, which it would be hard
to describe, especially through the tears and pain, we discussed
the various phases of the kinds of actions that could be taken.
Among other things, we talked to the FDA Staff about partial
action, unrelated to the parts per million concept. We sup­
plied them with some ideas for a substance use notification
system, since some of the members of the Staff were concerned
that if they went along with any part of the proposal, they
might never know what was going into food contact items. We
came up with some ideas on that--a tear-off form that might
even be used if that's the direction they wanted to go in.
"By the way, Tom Brown was not at that meeting.
X sub­
sequently found out he really did not have any idea of how
the meeting was going to go, which I consider most unfortunate
,
because the only way I know how to describe what happened to
us at that meeting, after the opening exchanges I have mentioned
above, is that we were 'Ramsified.' At the session, the state­
ment was made not once but several times by Hr. Ramsey that ’we
still think that these proposals that we advanced are scientifically
sound, but they are administratively or politically impossible
at the present time.’ I feel this was Ramsey's way of saying that
even though indirect additive regulation is a low-priority
area at FDA, we're too afraid to go ahead with anything that
will cut down on clearance requirements in any area.
"This Ramsey pronouncement came as quite a blow after Tom
Brown's promise at our January meeting. Tc» say we were shocked
would be to put it mildly. X was furious myself.
I personally
believe that a number of the members of the FDA Staff who were
there, like Mr. Buckley, Dr. McLaughlin and Mr. Holtz may have
been as shocked as we were at how the meeting came out. I
do not believe they anticipated the turn of events, and that's
why I say we were 'Ramsified.'
"Well, we could not very well leave the situation in this
posture so I talked with Tom Brown as soon as I could get to
him.
(He was out of town but I talked to him the following
week). He was, I think, tactfully apologetic but, nonetheless,
once a member of your staff to whom you have delegated res­
ponsibility has taken action, you really do not have much
choice other than to find a middle' position and at least
appear to back him.
"Thus, Mr. Brown could only suggest that we prepare a
peitition, the exact nature of which was not clear to me,
and X did as much probing as I could. What he said in sub­
stance was that, 'I suggest you prepare a petition to bring
this problem into focus, and I will promise you that the

ASI-PR 0001120

-11Commissioner will consider the petition despite what Ramsey
said,' Ramsey having said that if we were to press the matter,
he could not reconmend it to the Commissioner.
"Since that time, we have not had an adequate onoortunity to
work the petition problem out.
But we are working on one; we
have some drafts; we are in the process of preparing what you
might call a petition.
I can tell you that what we are trying
to prepare is what amounts to a report on the history of this
whole sordid affair, along with a request for relief. We
are really attempting to prepare a packaged proposal so that
it can be filed with FDA all right. However, it could also
be supplied to other authorities and speak for itself if. for
example, a Congressman were interested in reading it and taking
some kind of constructive action.
Thus, the draft petition
is very apt to mention the background about how FDA did not
keep its 1968 promise to Congress.
"We also have some ideas about the nature of the relief
we would like to see that may appear somewhat different and
slightly revolutionary to you when you read it.
I do not
want to get into that right now because I think it would be
premature, but we will try to send a draft out to you, as we
did on the GRAS list comnents, well in advance of your next
meeting so that we can use part of the next meeting to dis­
cuss the draft.
"Now, there is some help we could use from you. During
the course of discussions with Tom Brown, he suggested that our
'petition' should be backed up with data, and I kept asking
data like what? I even said:
'Suppose I attach a copy of the
National Conference on Indirect Food Additives transcript, would
this be "data" in this context?'
He indicated that probably
would not help too much.
"The mb of the matter is that in trying to think about
what kind of data we can provide to show that we really do have
a problem and FDA can and should help do something a^out it,
we expect to get some data on how much the extraction test
methods now used exaggerate real extraction after Bob Hiller
has a chance to analyze fully some of the data he'll be telling
you about later in the day in connection with his European
report. The additional data that we would like to have will
be requested of you. With the permission of your Steering
Committee, we are going to send out a questionnaire to attempt
to obtain this data, probably within the next month or two. It
should not be too difficult to complete and will be designed
to elicit your experience, time-wise, on any food additive
petitions you may have filed. In other words, it will ask you

ASI-Pr 000112!

-12just simple questions such as (1) what the subject of a petition
was, (2) when it was submitted to FDA, (3) when you were advised
that it was accepted for filing, (4) when the Notice of Filing
appeared, and (5) when final action was taken on the petition
in the nature of some form of regulation issued. Incidentally,
just so those of you who are devoted CCH readers will not chink
we are asking for something partly available in the literature,
let me point out that we realize we can get some of the infor­
mation mentioned from CCH and Food Chemical News and we will.
However, we would like to have documentation from you because
of the data gathering 'image* this will provide.
"We hope you will cooperate since we would like as many of
those questionnaire forms as we can get back.
*
"That's really the status of the Ramsey proposal as it now
stands. I hope I have given you enough background to understand
what we're doing. We have once again been asked to face up to
the fact that, as much trouble as the indirect additives field
is to all of us, it is by no means high priority with FDA.
I
don't know of any way to get real Commissioner-level attention
for it without being able to package the product. In summary,
we are now faced with the necessity of packaging up all of our
woes and suggestions for relief, and placing them in a readily
available container so that the package can be given to the
people that might be able to help. That’s what we now believe
we have to do, and we're working on it.
"Does anybody have any questions about the status of the
Ramsey proposal?
Max Goldfrank:
'When we sent out the request
for the Inter-industry Committee, you asked us for sug­
gestions.
I made the suggestion of how about going
back to Congressman Dingell? Or is he no longer inter­
ested?'
Heckman:
'I'll be glad to answer that question. I
thought 1 had implied the answer in what I said earlier.
This is another case where I don't think we can make any
progress unless we package' our product. That's true
for two reasons. In the first place, Mr. Dingell was
originally interested in the problem because Greg Potvin
who worked for him was a close friend and was interested
in sitting down for a couple of hours to listen to the
background.
Even after listening to it, he said that
he wouldn't have time to read all of the papers I gave
him. He, therefore, asked that a series of questions
be prepared that could be submitted to Commissioner

ASI-PR 0001122

-13Goddard when he was appearing before the Small Business
Subcommittee on a matter relating to drugs that really
had nothing to do with food additives.
So the reason
we could not easily go back to Dingell is because I
think we need the package to do the job.
We need to
give him something to read at his leisure and, chen,
in that way we would hope we could focus his attention
on it so that he will take an interest.
X think he
might take an interest, if we do it that way, and if
we can say we have exhausted all our avenues with FDA.
Heckman:

(in response to an unidentified question)

Our questionnaire will be designed only to elicit what
amounts to chronology.
It should be very simple, provided you can remember what petitions you have filed.
If any of you feel that you don't want your company
identified when you send your questionnaires'back,
please let us know that. 1 frankly hope that you
won't feel that way but if you do, we can identify the
companies as A, 3, C, D, E, F, if we have to.
"Let me turn now to the status of the GRAS proposal which is
the next item on the Agenda. I am assuming that all of you are re­
latively familiar with what I'm talking about. This relates to the
FDA proposal written by Alan Spiher that is supposed to set up
new criteria for how FDA is going to operate in the future relative
to things that have been heretofore GKAS. I spoke with Mr. Spiher
just before I left Washington and was advised that the proposal,
as drafted--and this is the one that was published in the Dec­
ember 8, 1970, Federal Register--is in the General Counsel's
office for review.
In due course I am sure that they will put
out son* form of this notice.
"Really, as I see it, all this Notice does, and we did file
Comments on it if you'll recall, is say somewhat vaguely what
FDA thinks it's going to do in the future with regard to GRAS items.
I have been told by Mr. Spiher that the Comments we filed are not
going to be explicitly mentioned in any way in the final Order,
presumably adopting the proposed new Section 121.3.
Instead, we've
been told that the thing to focus on is that no status changes
will be made--and this is now in the proposal--until the Food and
Drug Administration has had an opportunity to evaluate any new
findings about specific GRAS items.
"From our point of view, what this really means is that you
can consider the GRAS list. Section 121.101, anything that is not
on the list, but that you know is GRAS for other reasons, to be
intact until FDA comes forward with a proposal to de-list, put
out an interim regulation or promulgate a new regulation on a

ASI-

pp 0001123

-14particular GRAS item. According to what has been said by FDA,
the evaluations are going to be made in categories according to the
order of hazard of substances and their uses. Thus, once again
packaging materials will be low priority and will probably main­
tain present status for a long time.
,fcEhe one thing that I think you probably really should pay
attention to is, when orders start appearing, if they propose
to de-list, regulate, interim regulate, or what have you, any GRAS item
that you actually use in your formulations; You will want to be
alert, especially in those cases where a proposed action affects a
direct additive you happen to use in an indirect additive application.
If this happens, you would seem to have three alternatives.
One,
you can reformulate that item out of your product if the new list
is not going to cover it. The second one is to substitute another
i
GRAS item. And the third one is to propose to FDA in response to
any specific notice that any change in the status of the substance
be made so that you can use that material in indirect food additive
applications. For the moment then, all I am really saying to you is
to stay alert to future action on the GRAS list matter and be prepared
to protect your interests.
"Now, in this connection, a number of things are being tied to­
gether at FDA these days that should be mentioned.
For those
of you who may not have read it, I would strongly recommend that
jyou read, beginning on page 17 of the May 10 issue of Food
1 Chemical News, where there is an article called 'Toxicological
Criteria for Additives Previewed.' It's a lengthy discussion
so I really can not cover it here. To show you about some of the
vagaries of FDA activity, here are a couple of quotes from this
article:
'It has been known that FDAers have been working on
toxicological criteria for additives and Agency officials
recently disclosed that either they would be proposed
this year or abandoned. Kolbye this year (he's the Deputy
Director of the Bureau of Foods) told the annual meeting
of the Flavors and Extract Manufacturers Association
that he expects the criteria to be proposed in the Federal
Register although not at least for a month.'
"This set of testing criteria is supposed to, in some way or
another, replace or incorporate the idea of toxicological insignificance.
Presumably FDA is going to set up toxicological criteria so that,
for some things that are believed to be toxicologically insignificant,
you might only have to do LD 50's while on other things, you might have
to do 90 days studies, and so forth. All of this is going to play
into the GRAS list concept, too, as the Food Chemical News article
discussess.
"After you read the May 10 article, for fun and games, you
might take a look at this week's issue where the same matter is dis-

ASI-PR 0001124

-15cussed again. In this case Deputy Commissioner James B. Grant is
quoted as follows, relative to the GRAS list and the toxicological
criteria matter:
'The comments seem to indicate an underlying
concern in industry circles that FDA is planning
arbitrary and unilateral actions in revising
the GRAS list. I can assure you that this is
simply not so. A proposal will be published that
will name a specific substance or substances whose
status is being considered. Time will be pro­
vided for comments from any interested party.
This is the time during which we hope you will
come forward with any specific data which you
believe will support either GRAS listing or
will indicate the level of regulation that you
feel is required if a regulation is to issue.1
In the same presentation, Grant said flatly:
'that within the next six to eight months
FDA will publish its toxicological guidelines.'
"That shows you how timing works at FDA.
First, you hear they
will publish guidelines soon or abandon the idea. Then they will
'be out in perhaps a month or a little longer'; now it's six to
eight months. All we can do is wait to see what really happens.
"On the USDA proposed changes in its regulations which we dis­
cussed at some length at the last meeting, if you'll recall, and
on which we filed comments, 'the quick and dirty way' to tell
you about this is to tell you that more than 70 sets of comments
have been filed so considerable delay is to be expected. One
group of Western Meat Packers filed a statement demanding a
hearing and contesting the constitutionality of USDA's right
to prescribe labeling. The hearing was denied promptly.
"As far as I'm aware, our friends at USDA at least agree
with the comments we filed, which were fairly simple. Mr.
Sloan is operating as in the past and is not too concerned about
when the rulemaking is finalized so he can not give me any pre­
diction and I can not give you one.
"Meanwhile, I think that you can just say that we can continue
to operate as we have in the past on USDA and that's all to the
good.
"The last thing I want to mention is really a perennial.
It
comes up in so many and stfange ways that I thought I would caution
you at this opportunity once again about this matter of guaranties.
I just want to urge all of you once more, that, before you sign
a guarantee form submitted to you by a customer, you check with your
legal counsel, and, at the very least, read carefully the guaranty

ASI-PR 0001125

-16you are asked to sign.
"One form that I will probably use as a horrible example from
now on came Co my attention recently.
It included the stock lan­
guage that you all see but including some extra clauses which could
only terrify a legal department.
Here are some examples of what
you would have been agreeing to do if you had signed this
guaranty:
'...does hereby agree to indemnify and save the
buyer harmless from and against any and all charges
and proceedings brought by any governmental author­
ity against the article or buyer for or on account
of any alleged adulteration or misbranding of any
such article described in Paragraph 1 hereof for which
seller is responsible hereunder, including the loss
and reasonable expenses, including attorneys* fees in­
curred by buyer as a result thereof.'
"That first paragraph only relates to governmental action.
Catch the next clause:
'...does hereby agree to indemnify and save the
buyer harmless from and against any and all claims,
demands, actions, and class actions and causes of action
which are hereafter made or brought against the buyer
by any person for the recovery of damages for the
injury, illness and/or death of any person or animal which
is caused or alleged to have been caused by
the handling, consumption, or used by such person
or animal or any article shipped or delivered
hereunder by seller or buyer, including without
limitation any judgment rendered against buyer
in any such action, and the reasonable fees and
costs, if any, incurred by or on behalf of
buyer in connection therewith.*
"Now I'm not telling you not to sign this kind of guaranty if
you want to. All I am telling you is that you should realize that if
you sign a guaranty like that, you are not only in the plastics
business, you are in the insurance business so the least you should
do is consider collecting some type of premium for the policy.
"Thank you."

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-17Reports on Liaison With Other Organizations
Mr. Miller noted that those present would next hear the usual reports on the
activities of other organizations relating to the interests of the Committee.
Drug Packaging Materials Subcommittee
(Formerly PMA-SPI Liaison Group)
Chairman Miller called upon W. B. Ackart, Union Carbide Corporation, to de­
liver the following report relative to the PMA-SPI Liaison Group;
"The January 13, 1971, report of this group stated that the final
draft of our proposal for regulating polyolefins for packaging dry
drugs and the associated test methodology had been submitted to the
quality control section of the PMA. The methodology section of our
proposal was accepted by the Q.C. section and was thereupon submitted
for publication in the National Formulary and U. S. Pharmacopeia. The
section dealing with proposals for regulatory changes was deemed be­
yond the scope of the Q.C. section and we were referred to the Vice
President for Scientific Affairs of the PMA for any joint activity
in this area.
"in the discussion that followed this report, it became
obvious that the level of activity in the drug packaging field
is rising rapidly and that a much larger and more active group
will be necessary. Additional volunteers were recruited and
a reoTganizational meeting was held on March 24 at the office
of Mr. Heckman in Washington. This committee now consists of
the following:
P. E. Campbell (Phillips Petroleum), D. S. Dixler (Keller and
Heckman), G. H. Fuchs (Allied Chemical), J, Roy (Kerr Glass),
P. M. Sanders (Eli Lilly), M, E. Smith (0. I.), E. J, Szymanski
(Monsanto), W. M. Westveer (Daw), and Jerome H. Heckman.
"Subjects considered at this meeting included: (1) personnel
changes at FDA, (2) the polyolefin containers for dry drugs publica­
tion, (3) FDA's guidelines for IND's and NDA's, (4) FDA statement
of policy regarding new drug marketing practices and NDA's, (5)
contaminated intravenous fluids, (6) migration of phthalate plastici­
zers from blood storage bags, (7) safety closures, (8) renewed act­
ivity regarding testing of plastics for containers for parenterals,
and finally (9) a more appropriate name for this subcommittee.
"MajoT consideration was given to item (2) our publication on
polyolefin containers for packaging dry drugs and its current status
with the PMA. Due to faulty communications, it appeared that the PMA

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