Exhib i_t __3

June 19,

Edited Transcript of Presentation of
Jerome H„ Heckman, SPI Counsel at
1969 Meeting of SPI Food, Drug and Cosmetics
Packaging Materials Committee

Heckman
I'm glad to see all of you here.
I see there *
are a number of new people here and I 11 try to take
that into account as best I can in the way of providing
background on some of the subjects I'm going to discuss.
I'll have to ask some of you who are not new to bear
with me.
Those of you who have not been at every meeting
since the formation of this Committee m 1956 will have
some difficulty in picking up the threads but we'll do
our best.
I want to cover a couple of matters quickly
before I get into the meat of current problems which, of
course, relate to the National Conference on Indirect
Food Additives "aftermath '--the name we've giver, this
subject--and the so-called Ramsey proposal.
There have bee:-, some changes in the FDA Staff.
Willard Orr, with whom some of you have probably had
occasion to deal in the Petitions Control Branch, has
now moved into the feed additives field, and is no
longer available to help Bill Randolph with the handling
of Food Additive Petitions.*
Bill Randolph is, of course,
feeling quite swamped and petition processing is suffer­
ing along as usual
Another m passing item which some of you may
have been reading about is the fact that FDA is expecting
*

Since the meeting,
Mr. Orr.

Mr. William H.

Morgan has replaced

ASI-PR 0000950

very rr. ir moi ■ require'.'1
Over the ve,rs, ■■■-'■ <. ^ vlr
7tH
what is the fete add i1 :'
or P VC resins,
r wK; t-.
he has followed * he pro,-"
of
a copy of our Me v-, i
tv
:t
extra copies of the tano l VL (
for that- purpose.

■

ryiire r

'.ays -euppiy-qiiiv-o
cm

One re-isr 1 r‘" ‘ ir t"i = oa. ■,
because Mr, Ra'-dolpt -ova advised us --e-t
1 ’ o ; a s sea
FDA s Division of Chem i s t t y and Fold T-hoy
to i i /
to develop some sort jf
pi V o::o * n,-r
• _•■
d he pa -- ->d
out to those who arc t;~ i
ah Ol, t ■ i ; i
u S ome Ot her
relating to a stabi'izei , on e,'r •_ oxidant ,
adjuvant proposed for js-,; o 11
a 1 p'-lo- ■'is, - r at
east
with a broad spectrum if n 11 v"" ' ' s ' a,r
‘AC
' : 0 a
or . :
: l ' DA ,
single o^e .
Thir- are t
m >......... impor come to us e-d sa u
•'-<>
-■•noi' izer
or antioxidant and v r-

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b

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degree of success w 11 ^ a * m-h":
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ASI-PR 0000955

7

Another Kennedy Subcommittee inquiry many
of you will be interested in is
'Do you belive that
the agency's decision making procedures operate with
reasonable speed, considering the interests and issues
involved?
Assuming that faster processing and decision
making are desirable, how could they be achieved?"
We've given FDA our views on this question many times
so we would be interested in seeing how the agency
answers the Kennedy question if we are ever able to
determine the answerThe last question that I think might be of
some interest is one that asks:
What procedures does
the agency have for assessing the quality and efficiency
of its own performance?
How often and in what manner
does the agency review the continuing relevance of its
mission, goals, priorities, procedures and structure?
In what ways could such review be stimulated?..,'
Fascinating set of questions.
One sort of a separate type question posed
is whether the staff quality is adequate to handle the
complex and sophisticated issues presented to the agency.
There;s really only one answer FDA couLd give to that
question if it's going to
tell it like it is" but I
doubt if that answer will be given.
Does anyone have a question up to this point
in my report?
We usually do this by simply allowing
interruption whenever you see fit so those of you who
are new, chime right in.
Question:

Who is Bill Randolph?

Heckman:
Bill is m the Petitions Control. Branch
of FDA and is technically titled a 'Food Additives
Officer' which really doesnt' mean anything.
From our

ASI-PR 0000956

3

-

point of view, and as a practical matter, Bill Randolph
is the staff man who handies all of the administrative
processing of incidental, food additives petitions.
When
he gets help there will be another mar with him.
They
serve as what some might call coordinators in receiving
petitions, circulating them within FDA and notifying
petitioners regarding questions that arise, or petition
status.
Any letters you might receive on a petition
would probably come from Mr. Randolph or his co-worker
in the Petitions Control Branch.
Questionisn't Mr.
area?

Buckley also working

in this

Heckman;
Right, but Buckley has been and still
working on direct food additives problems only.

is

Question.
Do you have any indication at all, when
Spiher will be retiring? V
Heckmans
No.
Spiher, for those of you who don't
know, has a. position that's technical, just below
McFarland who is over-all. Chief of the Petitions Control
Branch,
McFarlard is really on top of Buckley, Randolph,
all of the people that work on petitions

Now, let me get into this major situation
that we really have to deal with
It relates to the
Ramsey proposal, but, for the sake of putting things in
perspective, I want to take a few minutes to review the
backgr ound.
Actually, l think it's fai.r to say that the
genesis of the Ramsey proposal was probably an American
Chemical Society meeting arranged by Ken Morgareidge way
Since this report was given, Mr
Spiher has been on
''special assignment' to the Consumer and Environmental Health
Service, FDA's parent entity.
He is, thus, not presently active
on food additives matters.
Whether he will return to basic FDA

*_/

ASI—PR 0000957

9

back in 1966,
Ar that meeting, somewhat to FDA's
surprise, although I really don't know why, a number
of papers were given that literally took the agency
to task in depth on the indirect food additives
question
It was perhaps the first time tba* there
was an entire series of papers publicly indicating
severe criticism of the way indirect food additives
are regulated,
*

I gave one of those papers, Jack Frawley
gave another.
There were a series of other papers-George Ingle gave one--that were more technically
oriented than critical,
Don McCollister of Dow gave
one, two men from Eastman discussed radioactive tracer
data.
It was at that time that the so-called
Frawley
Proposal" was first, advanced.
What Jack did was to comment
on the fact that FDA was doing a very poor job on in­
cidental, additives by, in effect, over-regulating,'
The
net result was a waste of scientific time and expertise.
As a means for delimiting petition film-'g he suggested
that FDA eliminate the need for regulating components of
packaging materials which were put into the package at
a level of less than 0,2 percent, so that if you made a
substance that was going to be used at a level of less
than 0,2 percent m a food package, and the substance
was not a heavy metal, a pesticide or a known carcinogen,
FDA should permit its use without requiring the filing
of a petition for issuance of a regulation
After 1.966 and despite what had been said in
these papers, nothing really changed, at least not right
away.
There was a lot of alleged internal discussion at
FDA about the feasibility of the
Frawley Approach , and
generally about the feasibility of doing something about
indirect food additives, but nothing really moved, because
there wasn't enough effective pressure being brought to
bear on the agency to make things move
^/(Cont.'1 work again
his present work.

is unclear,

as

is the exact nature of

ASI-PR 0000958

-:o-

Thereafter, approximately in August of
1967, it was suggested to a Congress iona ] Committee*/
that the indirect additives field was being badly
mishandled.
The reason that the situation was brought
to the attention of that particular committee was
because the Chairman of the Committee was and is Con­
gressman John Dingell. of Michigan,
Congressman Dmgell
had been on the original, committee^*/ that handled all
of the legislative work on the Food Additives Amendment,,
and had chaired many of the hearings.
The Congressman expressed an interest in
the interpretation that FDA was giving to the Food
Additives Amendment, particularly that portion of the
statutory language which provided the basis for FDA’s
authority to regulate incidental additives, (i.e. any
additive that "may reasonabl.y be expected to become a
component of foods }So, at his request, a series of
questions were prepared that were submitted to Dr
James Goddard, then Commissioner of FDA. at a Con­
gressional hearing.
Dr. Goddard was asked to have
answers to the questions within 30 days.
FDA set about attempting to prepare the
answers to the questions, but had some diffL.'ulty, to
say the least, because the questions were reasonably
searching.
Finally, because they couldn't really answer
a lot of the questions without conceding that the
incidental food additives situation was in a state of
confusion, they advised Congressman Dingo 1.1 that, as
a partial response to the questions, FDA was going to
call a national conference on indirect food additives
and that the agency would report back to him within 30
days after the conference.
J/
The House Select Sma 1 1 Business Subcommittee on
Regulatory Agencies,
* */ The House Interstate and Foreign Commerce Committee.

ASI-PR 0000959

Industry was given about a, month's notice
on the conference and we were totally ur.abie to get
any extension.
Before anyone knew what was going to
happen, FDA had sent out a meeting notice, and had
laid out a program which was rather vague.
On the one
hand, FDA was counting on industry to participate, but
on the other hand it had arranged things so that industry
would have little, if any opportunity to make a strong,
coherent presentation in opposition to the manner in which
incidental additives were being regulated.
In any event, under the auspices of SPI, we
got together representatives of the trade associations
representing the main packaging industries that we knew
had been called to come to the conference on indirect
food additives.
We had two pre-conference meetings and
all agreed on the basic industry position that should be
presented at the conference.
As a result, contrary to
some of FDA's expectations, we went into that conference
fairly well prepared.
One of the things that we all recommended
strongly was the establishment of a Government-Industry
Advisory Committee.
There was a great deal of debate on
this subject at the conference, some of which became
quite heated at times.
There was some strong resistance
to a Government-Industry Advisory Committee by FDA re­
presentatives which was not entirely clear.
If nothing
else, I think the conference served a useful purpose in
putting ’'on the record 1 some of the points of view of
industry.
By the way, I mentioned this at the last two
meetings but I wil.1 mention it again, I still, have
transcripts of the proceedings of the National. Conference
on Indirect Food Additives, so if any of you who have
not yet requested and received one would like to have a
complete transcript, which has a great deal of background
information of value, generally, by ail means drop me a
note, and we will be happy to send you a copy.

ASI-PR 0000960

r -

.■

b--k a 1 f

of your
.■ 0-9
-*
.n FDA
-a ayo-.^y
O" some proposed ?i :-"du,a
had published.
"‘"'2=0 Pr •- ■
■ r" drafted
by Mr
Alan SpjJ'or m-d
comments because. q>.ite fra i! o, we we ; ■'
joking for
anything at. ail * -re w u. : 1 u-. n/.b-'im1- a r-.a-s to
place industry's va'v“ ebwjf t Ke -. fr: 111 .-dditiveregulatory situation w- •= f o
1 ro~otd
T " proposed
regulations are still p-'riw'y -■_? d -.w
bc'~u promised
that they will rot be f r<? in-d, ir
■- 11 ; some
of these other more sjbst.--t ma- rv-b pro a - o resolved.
Now I've quit' you a:: :f tre k„ s i o background
about the subierrt.
After r he . - <■ . w . ‘ ■'
firetce, FDA
set to work m a" effoit to -om-' .eg i . t li something that
would at least be a pa'1 lie; Lve t - pa--keg’.-g materials
producers, a".d that, ■ u mov !, - d . i ‘
.msme
•. to the
publication of t 1
-a ■ ■ <=d
o
p.- worse : While

th a t

we i

be i

g

d

e f

:

Pr. ;d rentio".

other imports': opotar ivp fa - , —i spe ui, committee,
the Food Protect 10' 'mmto-.p oc th^
; ms ; Academy of
Sciences and the ha' m a-. Poseur'"-.
mm - r , during the
period between tm-e
t i m .i ,
'-'f- ■
-■
' cornet Food
Additives and -just pr i 'v ! ^ i IN' ' ~ ■■ b u. ot ; ■ jf the
Ramsey proposal., beg- ■ 'a :i <
- q - n;o.Tj a report
that is entitled ’ Q-.
1 m n * m -- r
In ; i r a fir Toxic­
ological] y Irsignf ica- t
«i c. . Additives
one

in Foods.
Jack Fr-iwo--/ u
in the development ,-,c rha-.

■>
r- ' o t.

r v "ig

ificsmt

part

tn rsse- -m: , 'JwO I. o rt ;; if ’ -jS.vS 1 3 lhat
t oxic o 1 oq i s t s haw n:mr' - o th.: • - 1 y s i o - t l,at 0
ppm
of anything in tl-e diet , c t ^r fu <r ow
-uremoger,
a pesticide, as do ft -ed l ■ t'-c r
- \m .
no, so. s and Regu­
lation A-t, or hu,iVy - ' ' '
-a/ h"o t.d-r-'d t ox i co 1 og 1 ca 1 ly
in s ign i f ican. t o'd b'-'f'Mr
.. « >r‘ ■ v : f tl'e t :x i on 1 og l s t s 1

ASI-PR 0000961

rime and ad?ntio" to establish safer'/.
T”rf
is ar easy way fa paraphrase what it
tl-'■ s -

-

rhi'tk

The problem, of coursp, as far as t'ae food
packaging industries are ronrsr'td, is in trying to
convert. 0..! ppm in tha diet to some meaningful, figure
in a package or a food.
To analyze for such an, amount,
you would measure the daily intake of a qiven type or
generic category of food awd then determine how much
of 'X" substance will be m that total, daily amount,
because parts per million really is a relative mathe­
matical concept.

.

Now at the last Committee meeting, m my
report, f spelled out for you the basic "oncepts that
we expected to be put forth in FDA s anticipated pro­
posal.
The FDA proposal, 1 advised, wou'>d be aimed at
amending Sem nn ; 2 i . 2 T 0 0 'if the Food Additive Regulations,
which, unfortunately, is often referred to at the ''Good
Manufacturing Practices" Regulation for incidental food
additives,
It's a *oos* term but the reason for that
is that Section 121.2500 is a genera! regulation that
precedes all of rhe specific; Food Additive Regulations,
and talks, i”> general t=rms, about what is deemed to be
good manufacturing practice ir, the use of a-, incidental
food additive
For examp5'.-. that's the section t^at
says you sha ! ! r.ot use anything that v; I I give a taste
or odor problem m foods
We advised at the lust session that- FDA would come
up with a proposal to .-mend that Section and ’could use it as a
means to exempt certain’ kinds of things from the necessity
for the f i ! i'-g
of food additive pet, it ions
At our Last
meeting l fold you about some of the details of the pro­
posal and what they were supposed to be.
W^at I told
you was essentially correct except that FDA made two
changes subsequent to my last report.
The basic
differences between what I told yon and the ''Ramsey

ASI-PR 0000962

proposal,' wb : cV, has f- ow bee” i f ;rn.i i y circulated
to the packaging industries cor e orom ■='. t , are twos ( U
instead of using the "economic poisons
definition m
the Proposal, paragraph -'d'; (5- says that certain specified
substances, i.e. heavy metals and >-a r c 1 r-ogens, will not be
exempt under any circumstances, and other substances that
have been demonstrated to produce toxic reactions when
present at levels of 40 ppm or less in the diet of man
or animal wlII not be exempt, and (2' the -ew "no migration”
phraseology in the proposed paragraph (d'; (5) <i! will make
it clear that the figure used, i e
h’ss than 0,05 ppm can
be determined bv appropriate extraction tests or calculation
(the previous language spoke only of no contribution greater
than 0,0 5 ppm to food', .
The language is a little confusing, but what
they were really saying here is that it you have a
component that's goi -g to be used m an adhesive or
in an article for repeated use, or if you can demonstrate
that no more than 0 05 ppm will get mto food, you don't
have to file a food additive petition unless it's a
heavy metal, a k-own carcinogen or a substance whLCh
has been demonstrated to be toxic at a level at less
than 40 ppmI" effect, this means that if there isn’t
any data on a substance, you don't have t.o demonstrate
that it's not toxic be 1 ov 40 ppm.
However, if it is
known for a faet that a substar-e has been demonstrated
to be toxic below 40 ppm it will not. be exempt.
You
would have t.o file a petition for such a substance, or
give up the use of the substance, which ls the other
a 1 ternative.
Quest l on.
The statement, you made with respect to
FDA's interpretation of the need for data on substances
that have not bee1' proven t o be toxic m the 40 ppm or
less, doesn't sour’d 'ike FDA.
Heckman:
1‘m not telling you what they're going
to accept, all T ‘m tryi-'q to tell you is that’s what FDA
had in mir.d whe- fho pioposal was wriMer,
In other words, if FD^ doesn't have any reason
to belive that a substar', re- is toxic it will assume
ASI-PR 0000963

that it's not toxin
Cbv i ous i.y, the
ru'e of reas or
has to come into play.
Tf you have any reason to
believe that a substance might be toxic then FDA might
ask you to provide some data
It’s not .'tear-rut at
this point, and because of that it's one of the things
we’re going to have to work on v^ry carefully
Questions.
Would you tell wtdtindustry associations
are involved ir. negotiations wit-h FDA on the
Pamsoy
proposal." and how the n.rqot lat i o"s are bei-,g handled?
Heckman%
As you arc probably aware, the subject
proposal was sent out under cover of a letter from Les
Ramsey to each individual trade association that had
participated in the national Conference on I "direct. Food
Additives,
We did not, of course, like the idea of
anything in. the nature of a divided industry approach,
industry, by industry
So instead of responding immediately
and arranging separate dates to meet, with FDA, we con­
ferred with our good friends in the American Re*per
Institute, they, having beer, m many ways the Secretariat
at the earlier inter-lodu3try meet, ir.qs
Dinar Wu1fsberg was good enough ro call another
in ter-industry meeting which was held on Ju-e 3
From
an SP r point of view w= participated m thit meeting
under the authority given us by the resolution vou passed
at the last Committee meeting.
Now, at the Jure 3 meeting
of the in ter-induetry group, a committee of six was
appointed to speak for the entire iri ter - indus try group.
The i n t e r - i r.d u s t r y group includes, m addition
to SPT, The National Flexible Packaging Association, the
American Paper Institute, the American Petroleum Institute,
The Soap and Deterge-r Mam u t" ac t" u r er s A sso" iat ion , the Can
Manufacturers Institute, the Adhesives Manufacturers, and
the Aluminum Association
Tv' ; s group, m a plenary session
on June 3. appointed a ■~;)m[TlLttee of six to negotiate with

ASI-PR 0000964

to

FDA as a whole, instead of separately.
The mandate
given to this committee of six, of which 1 now have
the honor of being chairman, is to arrange for suita­
ble meetings with FDA to discuss some of our mutual
problems.
11 is understood that the [nter-industrv ?ommitee will not negotiate all issues.
For example the Ad­
hesives Manufacturers are free to negotiate with FDA on their
own, as to whether or not the Adhesives hist should
remain in, or be eliminated from the Regulations.
So
too, SPI is free to have individual, negotiations with
FDA on matters of particular interest to us.
And that
is something I would like to see this committee discuss
at length, as soon as I finish giving you what amounts
to a background report.
After the June 3 meetmq I -ailed Mr
Ramsey
and he was very happy to hear that the [nter-Industry
group had been able to appoint a committee of just six
people to negotiate on behalf of all of the groups on
what we consider to be central issues.
The central
Issues that we have agreed to try to negotiate on are;
(1some means of better defining the
40 parts per
million
criterion that FDA is using, and i21 the
desirability of substituting the h-ir.guaq^ that was put
forth at our Inter industry meeting by Jack Frawley for
sections Id)(5) (i) and tii) of the Ramsey proposal.
The substitute language suqqestod by Jack
Frawley for section id! 15• ti) would read
As components
of food contact articles, provided any substance is present
in the container or coating, or ot'^er food contact surface,
at a level of 0.27- by
■ qhr , or loss.
Obviously that
would be a more useful, workable con-opt- because it woul.d
be much easier to establish whether a substa-ce is present
at a level of 0. 2h by weight of the food
surface

ASI-PR 0000965

than it would be to analyze
the food.

for parts

per million in

.As regards our proposed substitute section
(d) (5) (ii) , this is both a backup positron in a ^ay,
and it is also a position we should have anyway, at
least in my opinion.
The language wo'j.i advance as
a new section (d) (5)(ii■ of the proposal reads- 'As
components of food contact articles provided any sub­
stance 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 assuming 100°/
migration. ‘
In other words, we will suggest that the
0.05 ppm criterion be changed to 0.5 ppm, a figure we
believe to be much more helpful and realistic.
To date, we have had one meeting of the ad
hoc committee of six.
It was decided that, rather than
rush into a meeting with Food and Drug, it would be
better to delay such a meeting until we have had an
opportunity to accumulate a special kind of background
data.
What we have in mind is a kind of market basket
study in which the hundred or so foods used as an assumed
'market basket' by the Department of Agriculture will
be purchased in various stores and, by evaluating those
food purchases, an effort will be made to estimate how
much food is packaged in all categories of packaging
materials.
Then an estimate will be made as to what
might be the maximum percentage of foods packaged in
each particular packaging material.
Jack Frawley made a preliminary estimate
that 20 per cent of all foods are packaoed in paper,
and used this assumption, which is generally regarded
to be a very high estimate, as the basis for his con­
tention that 0.2 per cent of any component could be
present in a package without presenting any safety
pr ob 1 em .

A$I-Pr 0000966

Obviously, it is nor aoi-.y tbe possible
for us to do a truly definitive, s"i.entifi' study.
On the other hand, we hope to be -jb!e to -■une up with
something that FDA can have for its fi in ro justify
a more liberal position on t!> O.kf. oar"- t y^r mill ion
criteria set forth in the Ramsey proposal,
So the points I ve mentioned
the mes
we will be discussing with FDA.
p:e will r.ot bo
arguing about whether FDA should give letters or, "no
migration
situations or any of those otr^r questions,
but one of the things I really want to know from this
committee today is what other points you think should
be argued, perhaps on behalf of SFI mst-'ud of or
behalf of the food packaging industry as a whole.

•

Question:
Could you please explain a ,.itr;e more
about the basis for the position rhat no safety problems
occur when most components are present in a package at
a level of 0.2 per cent or less?
Is there any data
supporting that conclusion?
Heckman;
.7 d like Bob Miller, if he will, to
explain some of the background behind this Pruv].ey theory.
.Mil ler If anybody has any data o- n 'tool,
migrations of components or muter i-;: • i - t j feeds we
would certainly like to have it to include m this
document we're going to give to FDA, to support our
position.
In Jack Fruwley’s ACS paper, end subsequent
rewrites, he used the data Hercules has on ronr paper
migration into food, in addition to anofr.er ore that
Hercules had published sever'j! years ago on p ias t i'-iz er s
for PVC, to show how the 0 2/ of th-': tot-.1 pa-'kuqe ma­
terial for a component limit would be cased without
safety concerns so long as the component was not a
heavy metal, pesticide, or know-' carcinogen.
The rosins
and PVC data are all we have so if ooyo-e has any more

ASI-PR 0000967

-

:9 -

or better data op. actual migration to foods, we would
certainly like to have it as back-up information.
Questior:
Do you think FDA will accept the 0.2
per cent level., or less, theory?
Heckman:
This is a personal opinion, it s
certainly not Jack Fravley's, and mavbe not the opinion
of our Inter-Industry Committee, and it certainly won't
be reflected in our negotiations with FDA. but if 1 had
to give odds I wouid sav that our chances of getting
the 0.2 per cent concept adopted are not as good as our
chances of getting FDA to adopt the 0.5 ppm concept.
Question;
What's the possibility of getting a re­
vision of the generally understood list of heavy metals
that will not be exempt from regulation under the Ramsey
proposal?
HeckmanNot very good, due l- pari to the fa^t
that heavy metals are naturally present in the diet
already, so its no kind of argument with FDA at all
to point out the unavoidable presence of substances in
"natural" foods.
What they say in response to that
argument is 'we agree that those things are present in
the diet and there’s nothing we can do about that, but
we are not going to permit an increase- to the dietary
background of those metals and, therefore, the only way
to get them cleared ls by the pet it lop route."
In other
words, heavy metal.s will not be exempt from regulation
except in those generally accepted applications where
no petitions would be required, such as in
repeated
use" and "barrier1 situations.
Question.
Would you care to comment on what effect,
if any, the Ramsey proposal will have on FDA's present
policy of refusing to issue 1 no migration
letters?

ASI-PR 0000968

20

Heckman:
Well, that's a point we are going to
try to clarify.
T thmk, but I can t guarantee •'his,
that if we end up with a proposal that's workable, then
FDA will probably begin writing letters of concurrence
that are worthwhile again.
Thus, for example, if FDA
accepts an 0.5 ppm criteria and you submit a set of data
to FDA that shows that you have a test method that is
sensitive to 0,5 parts per million, and that you have
no migration at the level of the test method sensitivity,
and it is therefore your conclusion that you don't have
a food additive, I think that FDA would then send letter^
agreeing with such conclusions.
However, I can't guarantee
that, and I think the consensus is that we should not raise
that subject with FDA at this time.
That's a subject we
can go back to at another time, after we've accomplished
something substantial with regard to the proposal, itself.
Question?
Am i right in assuming that the Ramsey
proposal implies that FDA is willing to agree that with
certain specified exceptions, anything that is added
to a food contact surface at a level of 0 05 ppm, or
less, is safe?
Heckman;
Not really, all "DA is really doing is
agreeing not to ask you to demonstrate safety or anything
else if you've got a material or -ompo'-ert that is not
going to get into food at any level higher than 0*05
parts per million.
Disregard whether it is safe or not.
FDA won't ask you to demonstrate that it's safe by
means of a petition and ultimate regu la t io"> if you're
dealing with something that vou put mho the food
contact surface at a level of ]eS3 than 0-05 parts per
million.
We want them to raise that thrcshhold level
to 0,5 parts per million but, in any event, it's not
really a question of safety in the f inn . analysis, it's
a question of what you have to file petitio’-s for.

ASI-PR 0000969

I must apologize for having spent so much
of the Committee's time in discussing these matters,
but I think you will agree that the subject matter is
not the kind that lends itself to systematized pre­
paration and discussion.
In any event, I do hope you
have found our "information exchange
of the past hour
or so helpful and informative.
Thank you.

Editorial Note;
As lengthy as it is. all Committee members
should understand that the foregoing "edited transcript
does not. purport to cover the discussion at. the meeting
in full.
This is due in part to our attempts to make
the transcript reasonably coherent, a-'d lt part to the
fact that some portions of the tapes made at the session
were simply incomprehensible.
You have our apologies if
one of your questions, one of special ro-cern to you is
not reflected herein.
JEFOMF H.

HECK.MAN

ASI-PR 0000970