JUN 1

33

LAW OFFICE5

Keller

and

Heckman

JOSEPH E.KELLER
1712 N STREET, N. W.
JEROME H. HECKMAN
CHARLES M. MEEHAN

WASHINGTON, D. C. SOO30

TELEPHONE

WILLIAM H. BORGHESAKl) JR.
ROBERT

290-2700

R. TIEBNAN

CABLE ADDRESS "«euu»*

WAYNE V. BLACK
I HOMAS J. HUOHES.JB
OAVID L. HILL

June

4,

i969

To the Members of the SPX Food, Drug and Cosmetic
Packaging Materials Committee

Gentlemen:
The purpose of this letter will be to give you
a brief preliminary report on the meeting of what we are
calling for the time being the "Inter-Industry Committee
on Indirect Food Additive Regulation."
Incidentally,
please understand that this j.s by no means a fixed name
since the groups of industry representatives involved
are actually getting together rather informally with
no real intention to make our group a permanent fixture.
Also, m due course, Einar Wuifsberg, representing the
American Paper Institute, will be preparing and sending
us a set of minutes for yesterday's session so I will
not attempt to cover the meeting in detail here.
Instead,, we shall arrange to send you copies of the
minutes when they become available.
At yesterday's meeting, the procedure used
was one whereby I gave a brief presentation on some
of the points that occurred to me relative to the FDA
proposal for revision of Section 121.2500 of the Food
Additive Regulations, and then Jack Frawley informally
discussed his views on the proposal and its practical
worth.
A copy of the memorandum 1 prepared prior to
the meeting is enclosed herewith, as is a copy of a
d_raft jJack used in the discussion to point up the
ways in which he believes the FDA draft should be
revised to make it more valuable as an exempting
device, i.e. as a device for eLminating the need
for the filing of Food Additive Petitions m cases
Involving food packaging materials components believed
to be of no toxicological significance.
This material
should give you some idea of the focal points of
discussion.

ASI~pR

°00073i

2

After a great deai of rather wide-ranging
discussions of the various industries' points of view
relating to the FDA proposal, it was unanimously agreed
that an effort should be made to have a meeting with
the Food and Drug Administration Staff at which ail
of the industries would be represented jointly, and
at which certain salient points of "across-the-board"
interest could be raised.
The idea developed was
that these central points should be handled by a small
committee representing all of the industries, with
any points relating strictly to special interests
of any of the groups being handled m separate meetings
that each of them would seek to arrange.
More speci­
fically, the meeting culminated m the adoption of the
following Motion which should serve to give you a
reasonably good idea of what is now planned:
"Upon a motion made by Mr. Heckman,
seconded, and unanimously carried, it was
resolved that the Chairman of the inter­
industry group should appoint a committee
of approximately five persons to negotiate,
on behalf of the entire group of associa­
tions, with the officials of the Food and
Drug Administration it deems most appropriate
with a view towards il; ctt^m^ng clarifica­
tion of the so-called Ramsey orooosai, and
(2; attempting to bring about suitable
changes including those set forth as the
Frawiey (1; and uij points.
This committee
shall have the authority to speak on behalf
of the following organizations:
Can
Manufacturers Institute, American Paper
Institute, American Petroleum Institute,
Adhesives Manufacturers Association, The
Society of the Plastics Industry, Inc.,
National Flexible Products Association,
Soap and Detergents Association, and
Aluminum Association, and shall have the
duty to report back to the mter-mdustry
group on its efforts.
The committee shall
further take pains m its negotiations with
FDA to point out that its task is to nego­
tiate only on points of clarification of
language of general interest, and to discuss
the basic Frawiey points ill and (il; con­
cepts, it being understood that the individual
associations will deal separately with any
problems related to the special limited interests
of their members, e.g. the Adhesives Manufacturers
Association will deal by itself with the question
of whether the Section 121 2520 adhesives com­
ponents list should be deleted or continued."

ASI-PR 0000732

3

The committee
inter-industry group is

appointed to represent the
as follows:

Chairman:
Jerome H. Heckman
Dr. John P. Frawley [Hercules)
Einar T. Wulfsberg [American Paper Institute)
Lewis Burnett [Soap and Detergents Association)
Max Goldfrank tAdhesives Manufacturers Association)
0. M. Banks (American Petroleum Institute)
We have now called a meeting of the committeefor Friday, June 13.
At that time, an effort will be
made to develop plans for a satisfactory meeting with
the Food and Drug Administration.
We hope that this letter will serve to bring
all of you up to date on what is taking place at the
present time.
I doubt that I will be making a further
report on the situation until our Food, Drug and Cosmetic
Packaging Materials Committee meets on June 19 but I
would certainly hope to have more to tell you then.
If
any of you have questions in the meantime, please do
not hesitate to let us know.

ends

ASI-PR 0000733

§ 121.2500

General provisions applicable to Subpart F.

1 #

#

(d) ***

(5)

#

'

#

«

.

Substances (except heavy metals, as identified under Heavy

Metals Test in Food Chemicals Codex, and compounds of such heavy metals;
substances prohibited under §U09 (c)(3)(A) of the Federal Food, Drug, and
Cosmetic Act; and any other substances that have been demonstrated to product
toxic reactions when, present at levels of 4o parts per million or lesS in**
the diet of man or animals) used as provided under subsection (i), (ii),
i

(iii), (iv), (v) or (vi) of this subparagraph:
(i)

As components of food-contact articles, provided any substance
i

is present in the container or coating or other food contact surface at a
level of 0.2% by weight or less.
(ii)

As components of food-contact articles, provided any substance
i

i

so used contributes no more than 0.5 parts per million of additive to the

>

contacted food as determined by analysis of the food, or by appropriate
extraction studies, or by calculation asstiming lt)0 percent migration.
(iii)

As components of articles intended for use in contact with dry

food of type VIII described in table 1 of

3.21.2526(c), provided the finished

food-contact surface contains no free oils not otherwise permitted for such use
(iv)

As components of articles intended for repeated use in contact

with bulk quantities of food, provided the finished food-contact article is
thoroughly cleansed prior to first use in contact with food.
(v)

As components of defoaming agents employed prior to or during the

sheet-forming operation in the manufacture of paper and paperboard intended for
use in contact with food.
(vl)

As components of food-packaging adhesives complying with

$121.2520.

ASI-PR 0000734

Remarks of Jerome H, Heckman,
General Counsel, The Society
of the Plastics Industry, Inc
Prepared for
Meeting of Inter-Industry Committee
on Incidental Food Additive Regulations
June

3,

1969

Gentlemen:
My understanding of the framework for this
meeting is that it reflects a desire on the part of
all of us, representing our respective industries, to
compare notes so that as much m the way of intelligent
viewpoint as is possible can ultimately be conveyed
to the Food and Drug Administration m the "mdustry-byindustry" sessions called for m Mr. Ramsey's letter
of May 6.
Thus, I hope I am correct in thinking that
what Einar Wulfsberg really had m mind for me was the
noting of some points for possible mutual discussion,
rather than the providing of any definitive dissertation
on the legal implications of the FDA proposal m the
restrictive sense.
Actually, I think that about ail I really
could say in a narrow legalistic vein is that we can
see nothing objectionable or illegal about the Food and
Drug Administration's concept of using the sc-called
"Good Manufacturing Practices Regulation" Section
121.2500) as a vehicle for attempting to delimit the
areas where Food Additive Petitions will have to be
filed in the future.
Frankly, the oniy criticism
I have of FDA's concept here is that it simply
does not go far enough, although it would appear to
be a perfectly legal step in the right direction.
Since we do feel strongly that the proposal does not
do enough--or perhaps I should say, say enough--to
solve some basic practical problems which we believe
susceptible of immediate solution, I would certainly
hope that all of us, in every conversation we have
with the Food and Drug Administration Staff about the
proposal, will use the opportunity to emphasize our
understanding from Mr. Ramsey's letter that the move
contemplated is truly nothing more than "a first
response to comments received in connection with the

ASI-PR 0000735

2

February 13-14, 1968 Conference on indirect Food
Additives."
My thinking is that we should not
only emphasize the "first response" understanding, but
should use the informal conferences to try to get some
idea of what FDA may be considering m the way of further
responses.
As I see it, we should let it be known that
we would not be very well pleased j.f the matter of
further reform in the incidental additive regulatory
sphere was left m abeyance, or conveniently ignored,
for a long time after the instant proposal is formally
considered, and perhaps adopted.
Indeed, perhaos the
previous insistence on a continuing
Government-Industry
Advisory Committee to work towards brining about additional
significant changes should be restated "by all of us.
Aside from this basic comment and recommendation,
I would like to use this opportunity to make a few
'
personal observations about the FDA proposal per se,
my hope being that this wj.il help set the stage for
some free-wheeling discussion after Dr. Frawley deals
more fully with the scientific implications of what
the Food and Drug Administration is proposing to do.
As my first observation, and without meaning
to transgress into the scientific area, 1 would like
to note here that I, for one, continue to wonder why
the Food and Drug Administration cannot solve some
of its problems, and many of ours, by moving back to
what I will call the pre-Food Additives Amendment
Lehman doctrine as regards what constitutes insigni­
ficant extraction from packaging materials.
It seems
to me that nothing has really haopened since 1958 to
warrant a change from the criteria used then to pass
on the safety of food packaging materials components.
The only thing that has changed is that analytical
techniques have become more sophisticated so that
extraction into food simulating solvents, admittedly
designed to exaggerate grossly the potential migration
of packaging materials components into foods, has
become sophisticated to the point where cieariy
de minimis quantities of potential extractants now
show up m the analytical process.
While this
increased sensitivity of analytical techniques can
be important as regards regulation of direct additives
and pesticides residues, and may be generally interesting
from the viewpoint of the scientific aesthete vis a vis
packaging materials, no practical experience indicates
that the "approvals," now called "prior sanctions,"
issued freely before 1958 on the basis of data
showing less than 1 ppm extraction have ever created
any health hazard.
As we attempted to put this point
and the problem that has arisen in the comments filed

ASI-pft

0000736

3

on behalf of The Society of the Plastics Industry m
response to the Food and Drug Administration's August
1967 Notice of Proposed Rule Making looking towards
amendment of the Procedural Regulations:

8,

"Extraction studies xeveanng no
detectible extraction m accepted simulat­
ing solvents at a level higher than 1 ppm
were deemed satisfactory m all but a few
special cases to sustain non-additive status
before 1960.
Despite the fact that there is
no known instance of any material 'cleared'
under this criteria having given rise to
any public health problem ior even a remote
implication of one), m preparing to file a
petition for a 'virtual' non-migrant at the
current time, data must be supplied using
extraction methods sensitive to a level of
0.01 ppm.
Furthermore, toxicological
information requiring at least ninety-day,
two species studies are considered minimal
and are demanded m many situations where
extraction is detectible at any level above
0.01 ppm.
"Advances in analytical techniques
need not and should not be unreasonmgly
used as a basis for constantly changing
regulatory criteria m an area where all
available expertise, and aij. experience,
indicates that it is simply wasteful of
scarce scientific and administrative
talent to insist-on very costly, time
consuming studies for no purpose rationally
related to the public health."
With this background m mind, and despite the
fact that we recognize FDA's problem m attempting to
convert the National Academy of Sciences-National Research
Council finding that .1 ppm of any substance (other
than heavy metals, pesticides, and known carcinogens)
in the diet is toxicologicaily insignificant to an
amount which may be deemed toxicologicaily insigni­
ficant in a specific package or packaging material, we >
cannot understand why the old 1ess-than-l-ppm rule
of thumb employed by Dr. Lehman m rendering his
opinions cannot be pressed back into service.
In other
words, it seems to this layman that successful experience
should be relied upon by FDA to use 1 pom as a dividing
line between food additives and non-food additives since
this was done without any adverse consequences up until

A$I~pr 0000737

4

the adoption of the Food Additives Amendment, and even
after the adoption, until FDA stopped issuing its "nonadditive" status letters m 1960.
I simply cannot understand from the simplistic
point of view of pure logic ^as contrasted to scientific
mysticism) why the "expert body" that is FDA now finds
it impossible to make the same reasonable judgments
previously made that 1 ppm is a safe level at which to
draw the line when it has the benefit of the earlier wholly
positive experience using this criterion, and now has
the added scientific safety factor provided by the NAS-NRC
report.
I leave it to you to discuss the possibility
of taking this position m your conferences with the Food
and Drug Administration Staff in the meetings anticipated.
It simply seems to me that this is not an unreasonable .
position to take provided FDA's thinking can be reoriented
away from abusing the advances m analytical techniques
which have come to bear.
Again, from the layman's point of view, it
seems to me that while the new techniques may show
potential extraction into solvents at extremely low
levels which could not be detected prior to 1958, where
packaging materials are concerned these techniques do
not give practical cause for raising the threshold
level as to what constitutes a reasonable expectation
of a packaging materials component becoming a validly
recognizable component of foods.
My feeling is that
FDA should agree that the simulated solvents approach
is itself a sufficient exaggeration so that it may be
concluded m all but the most unusual cases that
anything which will not migrate into a solvent (at the
high temperatures and other exaggerated conditions used
in testing "to equilibrium"; at a level higher than 1 ppm :
may not reasonably be expected to become a component of
food and, therefore, should not be considered a food
additive.
I admit that the point I am making perhaps
has some loopholes from a scientific purist's point of
view, but I think it is time that scientific purism was
put in its proper place.
One other point seems to me to deserve mention
and discussion m connection with the FDA proposal which,
I suspect will be commanding most of your attention, i.e.
the proposal to exclude the need for Food Additive
Petitions where potential migration can be calculated
or demonstrated to be less than 0.05 ppm.
Assuming
that this criterion cannot be changed to a truly
useful level such as has been suggested m Dr. Frawley's
writings, the FDA proposal will only be helpful m those

ASI-PR 0000738

5

few cases where potential migration can be calculated
to be lower than 0.05 ppm due to the amount used m the
packaging material vis a vis the volume of substance to
be packaged, or perhaps where the amount used m the
package is so minute as to make one wonder whether
there is any purpose in its use m any case.
At the very best, and even assuming that there
might be test methods to detect 0.05 opm equivalent
levels as regards some substances, attempting to prove
the absence of potential migration at levels of 0.05 ppm
will be virtually impossible where extraction studies are
to be relied upon to establish the hypothesis unless a
standard surface-to-volume ratio for the testing can
be agreed upon, and finitely expressed by FDA.
The ratios which have been used m the past
have varied from 2-1 (volume to surface) up to 100-1
or more, depending on the intended use of the packaging
material to be expressed in a regulation.
It seems to us
that a standard ratio of 10-1 sthe ratio used in develop­
ing the so-called can enamels regulation, Section 121.2514)
might be a good starting point for standardizing m this
respect.
In any case, it would appear that trying to
settle definitely on some standard ratio would be a
worthwhile effort.
If this is done now, even if the
0.05 ppm regulatory criteria must be accepted for a
time, perhaps the ratio will prove a valuable baseline
for that day m the future when the 0.05 ppm level is
raised on the basis of experience to something more
realistic like 1 ppm.
Aside from these observations on the part of
the FDA proposal that is apt to provoke the most comment,
I would like to direct your attention to the necessity
for impressing the Food and Drug Administration with
the practical problems encountered because of the
regulatory scheme employed.
These are the day-to-day
problems that really come to bear m the most frustrating
and difficult ways because they relate to inhibitions
on sales of products which should, m fact, present
no problem.
The truth of the matter is that, because of
the general, though very vague recognition of purchasing
agents and others that FDA does somehow regulate packag­
ing materials for foods and drugs, your company personnel
must constantly be faced with the necessity for attempting
to provide some tangible evidence that a given product is
"FDA approved."
Due to the fact that purchasing agents

ASI-PR 0000739

-

6

-

and others not dealing with FDA on a day-to-day basis
cannot know the intricacies of FDA's regulatory aporoaches
and policies, it continues no be most difficult, and
sometimes impossible, to sell a product unless an FDA
letter, or very SDecific regulation can be cited and
explained to be applicable.
The problem is compounded
by the fact that, as Bill Randolph of FDA has recently
pointed out m a paper he gave m Nicaxagua, "FDA has
'no authority' to give 'approval' of individual
proprietary products."
The difficulty here ^.s that
what Mr. Randolph said may be a fact, but it does not
satisfy customers, nor does it leave salesmen with
any way to give the kind of assurances of product
safety that customers demand.
I believe that, as an absolute minimum, we
must elicit from FDA some type of promise, preferably
in the form of a written policy statement, regarding
when it will confirm the satisfactory status of
proprietary products under its regulations, including
the revised Section 121.2500.
What those of us who
deal with day-to-day Food and Drug Administration
regulatory problems, and, incidentally, inquiries from
foreign customers, must have at some point is a well
constructed procedural schematic whereby, m appropriate
cases, and when absolutely essential, we can readily and
expeditiously obtain from the Food and Drug Administration
Staff a simple letter of concurrence m appropriate product
status under the Food Additives Amendment of 1958.
Thus,
for example, we should be able to obtain unequivocal
letters concurring in non-food additive status due to
the absence of a reasonable expectation of a product's
becoming a component of food where the specific facts
set forth m a letter of inquiry call for such a conclu­
sion.
Letters of this type should no longer be withheld
as they have been since the Food and Drug Administration's
peculiar policy decision on so-called "no migration"
situations m 1960 and 1961.
If I have any "message" worth conveying today
at all, I think it is that we will have accomplished
virtually nothing if we are unable to move the Food and
Drug Administration m the direction of cooperating with
industry to resolve questions as to whether something is
or is not an uncleared food additive within the meaning
of the law.
There is no reason for the Food and Drug
Administration to avoid this question by peculiar seman­
tical exercises when the result o#- th'rs 'avoidance^ is
customer apprehension and unwillingness to use products
which may be safely employed because they are not expected
to become components of food, or for any other valid reason.

ASI-PR 0000740

7

The same type of letters that are given m cases involving
prior sanctioned or generally recognized as safe substances
(also exempt from the Food Additives Amendment of 1958j
should once again be given m the practical "no exDectation
of migration cases."
In short, FDA must somehow be
convinced to meet its obligations forthrightly so that it,
like the Department of Agriculture's Consumer and Marketing
Service (and like Dr. Lehman before I960; will make practical
judgments, and give accurate and direct, instead of artful,
answers to industry's status inquiries.
I hope we can discuss all of these matters fully
today, and that I may have contributed something in the
way of starting the dialogue.
Thank you.

ASI-PR 0000741