Exhibit A

Report of
Jerome H. Heckman, SPI Counsel
Prepared for SPI Food, Drug and
Cosmetics Packaging Materials Committee
Meeting
Washington, D. C.
November 7, 1968

Gentlemen:
It is good to see so many of you again.
Please let me
start by thanking all of you who were so understanding about my being
unable to attend your last meeting in April.
My family was very grate­
ful for the many expressions of sympathy received regarding my father's
passing.
It was a trying time so your understanding was deeply
appreciated.
I would also like to publicly thank my very capable asso­
ciate, Tom Hughes, for filling in on my behalf on extremely short
notice.
From what I have heard since April, Tom did a great job.
As a result, of course, he will now have to pay the usual price
for his success.
Thus, you will have noted that he is listed on
the Agenda to give you a report a little later on today on some
of the overseas developments which have come to our attention
recently.
In accordance with our custom, I will try to "hit some of
the high spots" here on a variety of matters.
In many instances, I
have attempted to abbreviate my own discussion of some of the topics
since, even with some abbreviation, I am afraid I must preempt a
rather substantial amount of your time at this meeting.
What I will
try to do today, as best I can, is to report on what I consider my
major topics, alluding only briefly to those which I believe others
will be covering in greater depth.
Again, in accordance with our custom,
I hope you will feel entirely free to interrupt at any time for such
questions, discussion, or even actions, you deem appropriate.

National Conference on Indirect Food Additives
In Tom’s report at the last meeting, he, and I am sure
some of the others who were present at, or participated in, the National
Conference on Indirect Food Additives briefed you on how the Con­
ference came to be, and how we organized industry participation in
it.
Since I was not present in April, I might merely add here
that we believe the Conference was a most worthwhile undertaking, if
for no other reason than because of the record it provided relative

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to industry's problems with the present regulatory scheme relating
to incidental food additives.
As of this moment, we cannot say that the Conference has
brought about patently obvious tangible results.
It may well be
that our FDA guests at today's luncheon will change this status
by giving us a more "official'1 insight into what steps the Food and
Drug Administration is planning as an aftermath
of the February
sessions.
In the meantime, however, I should at least remind all
of you—including especially those who were not at the Conference—
that the proceedings were fully transcribed.
This, in and of
itself, constitutes a real contribution as we see it.
I might also mention that we still have a fairly substan­
tial supply of the complete transcripts of the Conference in our
office so any of you who might like to have the background informa­
tion which the transcript provides are invited to let us know.
We
car. arrange to send you a copy but the transcript is some 309 pages
long so I am sure you will forgive us if, in mailing the material,
we make use of the lower class mailing rates, and ask you to anti­
cipate the slight delay this might occasion.
Aside from whatever benefits in the way of background
information the transcript provides to interested parties in both
this country and overseas—and we have had occasion to send copies
to contacts overseas who have found the transcript quite useful—we
believe that some psychological benefits of regulatory significance
have already accrued as a result of the Conference, and that other,
more recognizable benefits, will be forthcoming.
On the psychological side, and you will appreciate that
this is by no means easy to explain or understand, we have the
strong feeling that the FDA Staff has taken some of the points
made at the National Conference on Indirect Food Additives into
account in its day-to-day handling of Food Additive Petitions.
As a result, we believe that the staff is asking for at least slightly
less in the way of data in connection with some petitions than
might otherwise have been the case.
Likewise, we believe there is a
growing understanding at staff level of the need for delimiting
those areas where petitions will have to be filed in the future.
In other words, while it cannot be said that the so-called
"Frawley concept" has been or will be wholeheartedly embraced by
the regulatory agency, it does appear that some of the FDA
thinking is proceeding down more moderate lines with the necessity
for such a shift having been indicated by the forceful way in
which the Frawley approach has been presented and supported.
Hopefully, Mr. Ramsey will be giving us some clearer
indications in this connection later today.
He may even be in a
position to let us know more firmly whether the FDA staff proposal
for significant changes in the Food Additive Regulations which

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would limit the necessity for filing petitions is making real
progress at the top levels in the agency.
All of the information we have received up to now, and
much of this has already been called to your attention in our
correspondence
and by the trade press, indicates that the FDA staff
believes the necessity for filing petitions on indirect food
additives could be reduced by the adoption of added provisions
to the so-called "good manufacturing practices" regulation set
forth as Section 121.2500 of the present Food Additive Regulations.
At the risk of being repetitious, but so that those of you
who may not be aware of the movement, will have a clear idea of what
we understand the staff is proposing to do, let me point out here
that if the staff recommendations are adopted, Section 121.2500
will be amended to, in effect, classify the following items as
"non-additives," which may be used without petition type clearance,
as a matter of good manufacturing practice.
The language we have
seen to accomplish this change would result in the addition of the
following new Section (d)(5) to Section 121.2500:
"§121.2500

General provisions applicable to Subpart F.

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"(d)
Substances that under conditions of good
manufacturing practice may be safely used as compo­
nents of articles that contact food include the
following, subject to any prescribed limitations:
•

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•

"(5)
Substances (except heavy metals, as defined
in Food Chemicals Codex, and compounds of such heavy
metals; 'economic poisons', as defined in §2a of the
Federal Insecticide, Rodenticide, and Fungicide Act;
and substances prohibited under §409(0 (3) (A) of the
Federal Food, Drug, and Cosmetic Act) as provided
under subsection (i), (ii) , (lii) , uv) or (v) of this
subparagraph:
"(i)
As components of food-contact articles pro­
vided any substance so used contributes no more than
0.05 ppm of additives to the contacted food.
"(ii)
As components of articles intended for use
in contact with dry food of type VIII described m table
1 of §121.2526 (c) provided the finished food-contact
surface contains no free oils not otherwise permitted
for such use.

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"(lii)
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.
"(ivi
As components of defoaming agents employed
prior to or during the sheet-forming operation
in the manufacture of paper and paperboard intended
for use m contact with food.

"(v)
As components of food-packaging adhesives
complying with §121.2520."
According to the best advice we have, if and when FDA's
"topside" approves such a change in the regulations, it will not
be published immediately but, instead will be discussed informally
with representatives of the industries who participated in the
National Conference on Indirect Food Additives.
Presumably, at
least, this would give all of those interested an opportunity to
suggest changes in the proposal even before it is published and
time is allowed for official "Comment," as is required by the
Administrative Procedures Act.
If the matter does develop in this way procedurally,
we may well want to meet again with representatives of other
industries, as we did prior to the National Conference on
Indirect Food Additives, so that industry positions can be as
coherent, and therefore as effective, as possible.
Among other things, and again assuming that the pro­
posals we have seen are eventually advanced to us in an official
or semi-official way by FDA, I, for one, would like to see a
degree of clarification of at least one of the major proposals
we know about now.
The one I have in mind is the one that
would eliminate the need for Food Additive Petitions on "components
of food contact articles provided any substance so used contributes
no more than 0.05 ppm of additives to the contacted food."
In our view, this provision would need considerable
clarification to make it of any real value since, what we would
hope, is that it is intended to eliminate the need for petitions
on substances where "no more than 0.05 ppm of additives" are
detected in food simulating solvents under realistically
established tests.
If the presently contemplated language were
revised to make this intent clear, we believe a forward step of
consequence would have been taken.
On the other hand, if the
language is left as it is, and thus remains open to the interpre­
tation that petitions may be avoided only where an in-food test—
usually wholly impractical—shows that no more than 0.05 ppm finds
its way into the food, or if it is interpreted so that it will
cover only substances which would lead to no more than an 0.05 ppm
addition to food if all of the substance migrated from the
package, the provision will be virtually useless.

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without going into greater detail, let it suffice to
say that we believe the language we have seen is inadequate at
the moment, so we must hope that FDA will provide an opportunity
for clarification at the earliest possible opportunity . Other
aspects of the proposal could likewise point the way towards
a necessity for meeting with our sister packaging groups, and
working diligently to make reforms as useful as possible, all
towards the end of continued protection of the public but with
less of an unnecessary burden on industry.
With the various procedural possibilities in mind, one
of our first recommendations to you today is that you-empower
your Steering Committee to act on your behalf m any negotia­
tions which may become necessary, or appear desirable, as far
as meeting with other industry groups, or the FDA Staff is
concerned.
We believe that your best interests will be served
if you provide such authority here so that the Steering Com­
mittee can act promptly and effectively on your behalf as
circumstances dictate.
Before leaving the subject of the National Conference
on Indirect Food Additives to report more specifically on the
still pending proposed revision of the FDA Food Additive Pro­
cedural Regulations, I would like to call your attention to a
collateral development which, it seems to us, has a sort of
overlapping bearing on both of these matters.
In the October 28 issue of Food Chemical News, a story
appeared announcing that the Food and Drug Administration is
establishing a "compliance policy guidance system" which will
enable the agency to make public more of its current regulatory
policies.
According to the FCN article, the new system is being
established in FDA's Division of Case Guidance and "will update
and identify current FDA regulatory policies."
The article
indicates that the system "will include procedures for making
public advisory opinions, trade correspondence, and other formal
and informal regulatory policies."

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If this system does indeed come to be, we believe that
this will constitute a response, albeit an oblique one, to the
recommendation we made to the Food and Drug Administration in
both our SPI Comments on the Procedural Regulations and, again, in
our presentation at the National Conference on Indirect Food
Additives.
If you will recall, in both of these presentations,
we urged the agency to do something about the communications gap
that exists because those other than parties dealing on a
£ay-to-day basis with FDA have no way of knowing about the
shifting sands of regulatory policy which are brought to bear
in the handling of Food Additive Petitions, as well as in the
handling of very important requests for advisory opinions about
product status.
In our Comments we went into considerable

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detail on this point and urged the agency to adopt a system
similar to that used by the Federal Trade Commission for
publishing Advisory Opinions without revealing the names of
inquirers, or the details relative to any particular product.
We have the very definite impression that the pro­
cedure FDA is apparently planning to install as a new "compliance
policy guidance system” will, m actuality, be along the lines
that we suggested.*
If this is so, we can be grateful for a
modicum of progress in the slow process of bringing about meaning­
ful regulatory reform.

Status of FDA Proposed "Procedural Regulations"
To place this part of my report m perspective, let me
remind you that comments on the FDA proposal for a complete revi­
sion of its Procedural Regulations were submitted in a 69 page
document we filed on your behalf on November 6, 1967.
Among
other things, we strongly urged that FDA do nothing m the
way of adopting new Procedural Regulations until such time as
some of the more basic problems relating to incidental additive
regulations had been thoroughly aired, and agonizingly reappraised.
It was in this set of Comments that we first advanced the idea of
establishment of an Indus try .-Government Advisory Committee to do
the job of working over the regulatory scheme in a truly compre­
hensive way.
This recommendation for the establishment of an IndustryGovernment Advisory Committee was carried forward even more
forcefully m the National Conference on Indirect Food Additives.
Indeed, in summarizing the Conference, most of the FDA spokesmennoted that the one point that they had heard supported most
unanimously by all of the industries represented was the request
V Subsequent to the giving of this report, and during the question
and answer session held with Mr. L. L. Ramsey of the Food and
Drug Administration at the meeting, it was learned that the socalled "compliance policy guidance system" will not really be
along the lines of the Advisory Opinion procedure previously
recommended by SPI in its November 6, 1967 comments on the pro­
posed Procedural Regulations.
Instead, Mr. Ramsey advised that
this new system will be reflected by publication of some sort of
manual to recap the enforcement policies communicated confiden­
tially to the field staff of FDA during the past ten or fifteen
years.
He further advised that the only thing really "new" about
the matter is that the policies will now be made public informa­
tion for the first time.
He further indicated that the last
estimate he had heard of a possible publication date leads to a
conclusion that the availability of the material in question is
at least three years away.

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3
for establishment of an Industry-Government Advisory Committee
to reevaluate and deal with all aspects of the incidental
additives regulatory problem.
Strangely enough, we have not heard a great deal from
FDA about the Industry-Government Advisory Committee proposal in
recent months although we have been hearing much about the FDA
Staff plan to revise the "good manufacturing practices regula­
tion" to eliminate the need for petitions in a number of areas.
Whether this means that FDA is of the opinion that the IndustryGovernment Advisory Committee suggestion can be sidestepped by
the finalization of some proposal to eliminate the need for the
filing of petitions in specific areas is not clear yet.
In our view, the Industry-Government Advisory Com­
mittee ccr.cept should continue to be pressed as a matter of
policy.
Further, we are of the opinion that FDA should perhaps
again be urged to forego the publication of any final revision
of the procedural Regulations until such time as an IndustryGovernmenu Advisory Committee has been formed, and has made an
efforu uc come up with more realistic changes.
As far as we are aware at the moment, consideration of
the Procedural Regulations is m a state of limbo, the likelihood
being thau no moves will be made on this score until more definite
National Conference "aftermath action" is taken.
Nevertheless, we
believe it might be in order for this Committee of SPI to consider
reemphasizing our interest in having FDA appoint an IndustryGovernmenu Advisory Committee, and delay publication of any new
-Procedural Regulations, unless and until such an Advisory Com­
mittee has studied the situation, and has given the agency the
benefits of its thinking on how Procedural Regulations should
be written zo facilitate industry, as well as FDA, action
required under the Food Additives Amendment.
It seems to us that
a suitable Resolution in this connection might well be considered
with a view towards forwarding the same to the Food and Drug
Administration at such time as this might appear tactically
desirable.

Consideration of SPI Petitions Manual
While on this subject of the Procedural Regulations,
and to take up a point which I believe was discussed, but more
or less left in abeyance at your last meeting, I would like to
raise with you now a possibility for constructive Committee work
which I believe would prove helpful to the Food and Drug Adminis­
tration, as well as to plastics and other packaging interests.
I might note here that I have discussed my embryonic idea in
this connection with members of your Steering Committee, and
indeed in an informal way with our friends on the FDA Staff, on
a number cf occasions during the past year.
Everyone seems to

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feel that the idea has merit although it is also recognized that
the task it would involve would be a formidable one, demanding a
substantial expenditure of time and effort, as well as governmentindustry cooperation.
In a way at least, I first raised this idea in a semi­
official way in my own paper at the National Conference on Indirect
Food Additives when I asked the following question:
"On this matter of what petitions should contain,
would it not be better for FDA to avoid the adoption
of unduly restrictive procedural regulations such as
those recently proposed and, instead, work closely
with industry (perhaps through its trade association
spokesmen of the type here represented) to develop
more informative educational materials such as
manuals depicting in 'dummy form' how various types
of petitions should be structured?"
Since that time I have found that many FDA Staff members
do feel that it would be very constructive if publications could
be developed by a trade association such as SPI to depict con­
cretely what a good petition should look like to facilitate
consideration by the administrative agency, and, therefore, to
facilitate and expedite satisfactory regulatory action.
My
feeling is that this is an activity which should be undertaken,
perhaps as a cooperative effort by members of the Technical
Information Subcommittee, and the Lawyers' Advisory Subcommittee,
since the problems involved would undoubtedly bring into play both
the scientific and legal disciplines.
For your consideration, I would therefore recommend that
your Chairman be empowered to appoint a special committee to
develop a "Food Additives Petition Manual" which could eventually
be published as an SPI document and would, hopefully, set forth
sample Food Additive Petitions, using as prototypes fictitious or
real components, as you deem best.
Recognizing the fact that,
in actual petition situations, different types of substances must
be treated differently as a matter of common sense, it would seem
to us that such a Manual, to be as worthwhile as possible, would
need to include sample petitions relating to (1) a substance which
is only an adjuvant used with other packaging materials, (2) a
total formulation case, and (3) a basic polymer case.
There may be other areas which would need to be covered,
and certainly much thought would have to be given to the develop­
ment of a practical, as well as a suitable format for such a
publication.
Among other things, any committee appointed to work
on this project would need to decide whether extensive example
data on actual migration and/or toxicological studies would
need to be included, or whether it would suffice if this type
of material was simply blocked out m brief form, but with
sufficient particularity to provide a real guide for prospective
petitioners.
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It seems to me that, if nothing else is accomplished,
any manual of this type which we undertake to prepare, and
ultimately publish, should stress a syllogistic approach to the
preparation and filing of Food Additive Petitions.
While it
may not be possible to prepare a Manual which will answer every
question that might come up m the course of a petition problem,
the examples of such petitions set forth should at least make
it clear that a petition is, after all, a document which should
be fully self-contained, and m the purest possible sense
Logically dispositive of all questions that can be reasonably
anticipated.
My point here is difficult to make understood m the
abstract.
What I am trying to convey is the idea that, m our
opinion, a sound Manual should make it apparent that a good
petition must meet the following requirements, as we see it:
1.
The petition should first set forth suffi­
cient background about the petitioner and its
interest in the incidental food additive to set
the stage for the more detailed logical and technical
exposition m the Petition.
Very often, a complete
explanation of how the substance was "discovered"
for the particular use contemplated will cast a
great deal of heLpful light on the overall situa­
tion, and will obviate the need for extensive
explanations about such subjects as the usefulness
of the product.
2.
The petition should state m narrative
form how the petitioner analyzed his regulatory
problem, and set about undertaking whatever test
work he deemed necessary to provide the Food and
Drug Administration with a sound and complete
basis for promulgating a regulation.
On occasion,
this type of explanation, provided a sound and
thorough rationale is given, can help demonstrate
why it might be unnecessary to perform certain
extraction or other analytical work which might
be required in other circumstances.
Furthermore,
this type of explanation can, on occasion, set
forth a reasonable basis for satisfactory argu­
ments that additional toxicological studies are
not needed.
In this discussion, incidentally,
such subjects as an estimate of how much of the
diet might be packaged m materials containing
the substance of the petition can be set forth
to provide FDA with a rational basis for concur­
rence m the petitioner's point of view about the
amount of technical data required to give adequate
assurances of safety.

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3.
Obviously, the petition will always need
to discuss the ultimate conclusions reached m
connection with the technical work done to support
safety of the additive.
As I have on occasion
indicated to the laboratory people with whom we have
worked on Food Additive Petitions, we recommend that
their work, and their reports, be prepared m the same
way that they would prepare documentation if they
were readying themselves to be expert witnesses m
a lawsuit, or administrative hearing.
We always
seem to have some difficulty m making our intent
in this connection clear.
The idea, as we see it, is that the people
who prepare either analytical or toxicological
data to be used as appendices for petitions—and
we normally like to supply the complete technical
data as appendices, referring only to the conclu­
sions to be drawn from the technical reports in the
body of a petition—should recognize that they are,
in effect, preparing expert testimony which the
Food and Drug Administration will be relying upon
m its analysis of the total petition.
For those of you who may not have had much
occasion to prepare expert testimony, let us point
out here that, to be effective, such testimony
must always be fully explanatory m and of itself.
Nothing should be left to the imagination on the
assumption that the data will be reviewed by
another expert who "will know what you mean."
In other words, we believe that an analytical report
should state m clear, complete, and narrative form
why certain tests were selected for the work, how
one could be assured that these tests were valid
for the intended analytical purpose, and how the
tests were actually conducted.
The report should
also, obviously, include the data obtained but
the expert, because he is an expert, should not
leave the matter there.
As an absolute essential—as the "punch line"
for the technical report, if you will—it should
state the expert's conclusions based on the data
he has compiled.
It should also include any
relevant observations that can be made on the basis
of the scientist's general expertise m the field.
An expert witness who simply performs technical
studies and cannot explain what the studies demon­
strate in support of a petition, or set forth how
his expertise permits further relevant conclusions,
is virtually useless.
The same is true of an

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analytical report which assumes that those who
review the data will understand why it was
accumulated ir. the way it was, and what it is
intended to demonstrate.
The by-word should be
"assume nothing" and "explain everything."
4.
The body of the petition should be used
to rationalize all of its parts, including any
appendices.
In every case one of those appendices
should be a proposed regulation m precisely the
form in which the petitioner believes the Food
and Drug Administration should promulgate a response
to his filing.
I realize that many of you have probably filed petitions
which meet the essentials of this listing.
On the other hand, I
know from my own experience, and from what various FDA Staff
members have told us that this is by no means universally true.
Indeed, dissatisfaction with so many of the petitions filed thus
far is what led to the proposal for revised Procedural Regulations.
We happen to think that this is the wrong way to solve the
problem, and that a better way would be to prepare sample petitions
as an educational tool to improve the situation.
It is for this
reason that we recommend the approach I have been discussing.
As a final word on this subject, I might point out here
that we have discussed this idea with many members of the FDA
Staff, and have reason to believe that we could count on the
agency's cooperation if we set about preparing a manual of the
type suggested.
This type of cooperation would certainly include
FDA's help in reviewing our drafts, and making suggestions as
might be indicated.
It might even include some type of FDA letter
or other note of approval which might be included in the manual
although this is not entirely necessary, nor can we say that
there is any advance commitment in this connection.

Regulatory Developments Regarding Plastics for Drug Use
As I hope all of you are aware by now, the SPI Manual
entitled "Plastics Packaging for Drug Products—the Regulatory
Story" has been available for quite some time and has, we believe,
been widely disseminated.
Even so, we find ourselves continually
explaining how regulation of packaging materials for drugs and
cosmetics differs substantially from the regulatory approach
employed in the case of food packaging materials.
We still
hear the plaguing question: "Is .this product FDA approved for
drug packaging?" from a great many drug people, as well as from
packaging suppliers.
The availability of the drug manual does
help to answer some of these questions.

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Aside from the educational effort that this Manual is
intended to further, there has been progress in the work with
the Pharmaceutical Manufacturers Association but I will leave a
discussion of this subject to Wat Ackart who will be talking with
you later.
The main development or item I would like to call to
your attention relates to a Notice published by the Food and Drug
Administration m the July 11 Federal Register at Pages 9954
through 9955.
This Notice amended various sections of the New
Drug Procedural Regulations dealing with so-called "Supplemental
Applications" so as to eliminate the need for filing such
Supplemental New Drug Applications under certain conditions.
As a result of this Notice, it is no longer necessary for drug
companies to file Supplemental New Drug Applications m cases
where, among other things, they are planning "a different con­
tainer size for solid oral dosage forms where container and
closure are of the same materials as those provided for m the
approved application."
Other situations involving relatively
minor changes in drug production were relieved of the require­
ment for the filing of Supplemental New Drug Applications.
Perhaps of even greater significance is the fact that,
in issuing this Notice, FDA stated that "the Food and Drug
Administration will consider any categories suggested by interested
persons of changes that may be appropriate for inclusion in
Section 130.9(a)(5) as not requiring prior approval of a
Supplemental Application for implementation."
The reason this
could become significant is because it seems to us that, for the first
time, the agency has provided an avenue whereby we might be able
to eliminate the drug manufacturers' need for filing supplemental
applications on other changes in his packaging program, assuming,
of course, that we can identify areas where such changes should
not present a cause of concern to FDA, and, therefore, might be
listed as exempt from the Supplemental New Drug Application
requirement.
Whether or not, for example, FDA might be willing to
take the position that Supplemental New Drug Applications need
not be filed for a change m the packaging of all dry drugs from
currently used materials to olefin polymer bottles is a question
we think might be explored.
Depending on your wishes in this
connection, it may well be that we could consider setting up a
conference with the appropriate FDA Staff people to discuss this
area and determine further what the possibilities are.
I am sure that I need not point out that, if it were
possible to exempt such an area as the one I have used as an
exemple from the necessity for the filing of Supplemental New
Drug Applications, some interesting new markets might be opened
up, or at least made less difficult to enter.
For this reason,
we recommend that the Committee consider instructing the

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Pharmaceutical Manufacturers Association-SPI Liaison group, or
some other ad hoc committee, to take this possibility up with
the Pharmaceutical Manufacturers if you think necessary, and
then be empowered to explore the situation with the Food and
Drug Administration Staff.
We would, of course, be very happy
to help with this project.

Publications of

Interest

During the past several months there have been, as
always, a number of articles and publications which many of you
would find of interest.
We do not compile bibliographies of
such items for these meetings but I do try to mention any which
seem to us to be of particular significance.
In this vein, I would like to call your attention to
the availability of the first volume in a planned series being
published by the Institute of European Studies of the Food Law
Research Center of Brussels University.
This first volume is
entitled "Fundamental Principles and Objectives of a Comparative
Food Law".
The publication seems to us to be of unusual value
because of the survey type treatment, and commentary, it provides
on the basic concepts of food and food additive regulation
throughout the world.
As far as we know, the
through a Mr. Albert J. Phiebig,
New York, 10602.
Mr. Phiebig, I
agent handling this publication,
tag on this first volume, by the

best way to obtain the book is
Post Office Box 352, White Plains,
believe, serves as the American
and perhaps others.
The price
way, is $6.

In this same area, and for those who may not have seen
it, you may want to look at the September issue of Modern
Packaging which contains articles by Alan Spiher and Jack Frawley
under the heading "Ten Years of Food Law—Has it Been Worth the
Effort?"
Jack's paper while, as usual, excellent, constitutes
only an abbreviated restatement of what I believe we can call the
industry point of view on the Food Additives Amendment.
Mr.
Spiher's statement, as you might expect in light of Mr. Spiher's
background at FDA, is a general apologia for regulation of food
additives.
I doubt that it will contribute a great deal to your
knowledge but you might want to look the article over.
One other article that I have noted lately appeared in
the October 10, 1968 issue of the Food and Drug Packager.
This
article was entitled "PVC for Foods—Some Points to Ponder" and
was written by Mr. William A. Larkin, Market Manager for Plastic
Product Activities at M & T Chemicals Inc.
To a degree at least,
Mr. Larkin has attempted to provide some of the background on the
only tin stabilizer regulation thus far promulgated by the Food
and Drug Administration.

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This article does point up the one major problem that
exists as a result of the regulatory approach used in the tin
stabilizer regulation.
That approach, as all of you undoubtedly
know, involves the necessity for applying a so-called "in-food"
test.
The use of such a test imposes a burden on the food pro­
cessor who is the only one that can apply it, and this undoubtedly
explains why we have not yet seen a great influx of tin stabilized
PVC bottles in the food packaging area.
*

*

•

There have, of course, been other developments of
interest during the several months that have elapsed since our
last meeting.
Information about some of them will be conveyed to
you by subsequent reports today.
Due to the length of my report,
let me conclude by simply noting that there is a possibility that,
by the time of our next meeting, the latest Department of Health,
Education, and Welfare reorganization plan may have been put into
effect.
I will not dwell on this subject other than to say that,
as far as we can determine, while FDA may then be operating under
the aegis of the new Consumer Protection and Environmental Health
Service, and while there may or may not be a change m the Office
of the Commissioner, it appears to us that the reorganization
will not directly affect any of your activities or interests.
To put it simply, all that we are seeing or anticipate are some
additional title changes, office shifts, and more "musical chairs"
playing, but no real revisions of substance for those interested
in incidental food additives.
I thank you sincerely for your patience.

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