FEB 2 1 1968
IAW OFFICES

Keller anb Heckman
JOSEPH E.KELLER
1712 N STREET, N. W.

JEROME H. HECKMAN

WASHINGTON, D. C. £0030

CHARLES M, MEEHAN

telephone

WILLIAM H. BOROHESANI, JR.

ssoe-eroo

CABLE ADDRESS "KELMAN’

ROBERT R, TlERNAN
WAYNE V. SLACK
THOMAS .1. HUOIIES, JR.

February 19,

JLD
AliS

1968

To the Members of the SPI Food Packaging Materials
Committee

Re:

National Conference on Indirect
Food Additives

Gentlemen:

Ret. To:
As a convenient way of providing those of yqftllc:
who were not in attendance at the above-referenced Con­
ference with something of a report on developments, we
have obtained permission to reproduce, and are herewith
enclosing Pages 3 through 15 of this week's issue of
Food Chemical News.
The Editor of the publication, Mr.
Louis Rothschild, has indicated to us that he expects
to give the sessions some further coverage in his
next issue but the enclosed should serve to provide
you with an indication of the thrust of the sessions,
at least for the time being.
According to other information we have received,
copies of the verbatim transcript of the Conference will
be available from the reporting company by Tuesday of
this week.
Those of you who wish to do so may obtain
copies of the transcript by writing to the reporting
company at the following address:
Ace - Federal Reporters, Inc.
415 Second Street, N. E.
Washington, D. C.
20002
Incidentally, the cost for the transcript will be 17jd
per page and we understand that the total charges should
be somewhere between $40 and $60.
Many of you might
find it most worthwhile to have all of the material
since, if nothing else, it could prove helpful to you

ASI-PR 0000573

2

in explaining various characteristics of the food
additive regulatory scheme to your own associates,
as well as to customers.
As far as follow-up work is concerned,
during the next week I will be with George Ingle
at the SPI Board of Directors meeting where we
believe we shall have some opportunity to review
the entire situation, and consider ways in which
the momentum for reform so clearly evident during
the Conference may perhaps be maintained.
At the
same time, we shall be discussing plans for our next
SPI Food Packaging Materials Committee meeting so
I am sure that I will be in touch with you again in
these connections fairly soon.
Meanwhile, we
think it is fair to say that there is already some
impetus for the Food and Drug Administration to
take affirmative action, at least to the extent
of responding to an inter-industry letter forwarded
to Dr. Goddard on February 9, 1968.
For your further
information in this connection, a copy of this
important letter is also enclosed herewith.
Cordially yours

ends

ASI-Pr 0000574

t

—•„ 1 :
Li

^

------------ 3
~
. |
M~mJ

"t n
- r-

n r -an r 7^
Vn
l UL3

— .. -- . i U U *i Lrf ^^7 ^ ^

Editors: Louis Rothschild, Jr.; Raymond Galant
Subscription Manager: Natalie Pargas

February 19,

1968
w

FDA AGREES TO CONSIDER FRAW1EY PROPOSAL ON INDIRECT ADDITIVES
WITH OBVIOUS RELUCTANCE; "MIDDLE GROUND" SUGGESTED AT MEETING
Spokesmen for the Food and Drug-Administration sharply challenged a proposal
by Hercules' Dr. John P. Frawley to exempt most packaging materials from
food additive administrative procedures at last week's indirect additives con­
ference held by the agency in Washington (See FOOD CHEMICAL NEWS, Jan. 22,
Page 21; Feb. 5, Page 16; and Feb. 5, Page 18).
1
Frawley has formally proposed that indirect additives - - except for heavy
metals and pesticides — be excluded from the Petitioning requirement if they
are used at (E_2% or less of a formulation in accordance with good manufacturing
practice. There has been a great deal of interest in his proposal.
FDA statements at the Feb. 13-14 meeting were the first formal response to
the Frawley proposal. Dr. W H. Summerson, director of FDA's Bureau of
Science, said he would not "dispute directly" with Frawley, but said his paper
was a "justification" of FDA's policy. Actually, it was difficult to interpret
the Summerson presentation as other than a rejection of the Frawley proposal.
However, FDA-ers seemed to modify their stance during the meeting and they
made it clear at the end that the Frawley proposal will receive consideration.
There were even suggestions on both the part of industry and FDA of seeking
a "middle ground" position between that of the agency and that represented by
Frawley's proposal.
FDA-ers Speak of Changes, but Resist Industry Proposals
Despite promises by FDA-ers, including Commissioner Goddard, that the
conference was directed towards changes in the handling of indirect additives,
Summerson and L. L. Ramsey, Assistant Bureau_of Science Director for Regu­
latory Programs, seemed reluctant to grant that either of two major industry
proposals had any merit.
There was industrial unanimity on either the Frawley proposal or some variation
of it, and on the desirability of forming an FDA-Industry Advisory Committee to
work on the overall problems of indirect additives. Regarding the committee,
Summerson again appeared reluctant to consider such a step, but ultimately
gave qualified approval to the recommendation (See following story).
ASI-PR 0000575

(
• Page 4
February 19,

1963

FOOD CHEMICAL. NEWS

Industry representatives at the meeting, generally, were aware that the confer­
ence had been inspired by pressure from a House Small Business subcommittee.
The calling of the meeting enabled FDA to tell the subcommittee that it was
"doing something" with regard to indirect additives. This circumstance, plus
the apparent resistance of the FDA-ers to the industry suggestions, left many
industry representatives extremely skeptical at the end of the day and a half
meeting.
The possibility of a "middle ground" solution to the "significant" migration
problem was raised after Ramsey, m his paper. said:
"Before beginning the extractability studies for a minor
component of a food contact surface, one is well advised
to make a computation of the amount which might be added
to food if it all migrated. If such computation showed tttat
no more than 0.01 p.p. m. cf the substance could possibly
be added to the food, the e;L -acts usually need not be
tested for such substance. The acceptability ox the sensitivity
level achieved in any analysis to snow the likely level of
migration depends upon the toxicity of the substance.
It has never been the intention of FDA to require, and we
do not now require, the industry to pursue an analytical
showing of the level of migration ar.y lower than
considerations of safety demand. Thus, the sensitivity
of an analytical method deemed satisfactory for showing
the level of possible migration into food may range all
the way from 1 or 2 p. p. b. to several p. p. m. "
Summerson explained that, "If the amount expected in any food is equivalent
of 0.01 p.p. m. or less, we consider it 'virtual lack of migration' and request
only an LD50 on jthe chemical. " He said if the amount ranges between 0. 01
p. p. m. and 3 p. p. m. the agency reque sts 90-day toxicity studies on two species
of animals. For extractives over 3 p. p. m., Summerson said, the agency requests
long-term feeding studies. He pointed out that there have been some exceptions
to these rules.
Under questioning, Summerson said there is a "soundness of certain portions
of Dr. Frawley's thesis, " conceding that there is some "unjustifiable expense"
for testing. Asked whether FDA will provide a "documented commentary" on
the Frawley proposal, Summerson replied: "Undoubtedly. "
Noting Frawley's position and current FDA policy, Summerson said, "Some­
where in between wLi be a position that both Dr. Frawley and FDA can live with. "

•

Frawley noted that FDA "is willing to accept 0. 01 p.p. m. " without toxicological
work, noting that he has proposed a level of 0. 1 p. p. m. without studies. It is
"just a matter of degree, " he commented. Noting that FDA, at low levels,
requires just an LD^q, he said this "doesn't tell you a thing. " Frawley urged
FDA and industry to find a "middle ground. "

ASI-PR 0000576

(

February 19,

Page 5
FOOD CHEMICAL XEW

1968

Saying that Frawley's proposal will he seriously considered, Sumrr.erson - - who
denied that testing over the past 10 years has represented a waste of time and
money - - said he would like to be able to permit the avoidance of some toxi­
cological work. "This is what we're trying to shoot for, " he added.
Fred J. Delmore, director of FDA's Bureau of Voluntary Compliance, said he
does not feel that FD^ and industry views "are too far apart. " Jerome H.
Heckman, representing the Society of the Plastics Industry, said a "middle
ground" approach seems "a good place to start. 11
Frawley Proposal Praised for "Soundness, " Hit as "Sheer Nonsense"
Despite Summerson's concession that there is "soundness" in part of Frawley's
proposal, the FDA-er said much of what Frawley proposed for a "single cut­
off place" is "sheer nonsense. "
Summerson's paper, which dealt almost solely with the Frawley proposal,
said, in part:
"Unless premarketing clearance is practiced, the only
method of detecting harmful effects is retrospective with
respect to exposure to the suspected agent. The latent or
'incubation' period from the rime a chemical agent is
first applied to the human being until the time that cancer
occurs is often 10 years or more. This means that one
may have to wait a number of years before results of an
exposure may even be detected. It is obvious, therefore,
that after the 10 year period, with changing food habits,
additives and packaging, it is well nigh impossible to isolate
an additive as the original causative agent of a cancer.
Thus, if we are* to give the consumer the protection he
expects and demands, we must require premarket testing.
"This seems obvious when we describe it this way, but even
today we have offered to us a statement to the effect that the
proponent feels no food additive clearance is necessary because
he has no knowledge of any bad effects from his product.
" x x x unless a relatively acute poison is involved an effect
is not likely to be routinely traced to a causative agent in
food or packaging. "
Summerson said that unless a component is "generally recognized as safe" or has
a prior sanction, "it seems reasonable to expect that research must be done to
establish whether or not any component of the packaging material will get into the
food. " He added, "If the answer to the question is 'yes, 1 then the research
should show how much may get in and whether this amount is safe for the people
who may eat the food. " He continued:
ASI-PR 0000577

s

Page 6
February 19, 1968

FOOD CHEMICAL NEWS

"Certainly if there is no reasonable expectation of migration
or if the amount of migration is 'insignificant' there is no need
for animal feeding data. On the other hand, does the toxicity
data to date indicate that there is need for toxicity testing on
the food packaging chemicals which do migrate? Can we
assume that any component of a food container that does
not exceed a certain amount, say 0. 2%, will always give an
insignificant amount (less than 0. 1 p, p. m.) in the total diet
and therefore be safe? If we eliminate the pesticides, heavy
metals, and carcinogens . . . , this generalization has
considerable appeal and some reliability on the basis of
'published' toxicity data.
"This generalization does not take into consideration whole
meals in packaged materials, the use of an ingredient in
n: 'rrp than one class of packaging material, and the additive
effect of similar ingredients. Nor does it account for the
food faddists or other individuals with unusual food preferences
who choose such unbalanced diets which would contain a
disproportionate amount of a migrating compound from
packaging material. Add to these the probability that thick
containers, such as plastic bottles, contribute far more to
the food than plastic coating of a few mils thickness of the
same subs.ance. "
Summerson said chat, "Long-term feeding studies as reported in the literature
may not be representative of the total scientific knowledge on all possible and
useful food packaging chemicals. "
The FDA-er said that some plasticizers extract in fatty foods at 100 p. p. m.
or more in the total diet. Those in common use have low toxicity, he said,
but FDA has had requests for use of triorthocresyl phosphate and others could
also be toxic. He noted that tight restrictions are placed on certain monomers,
such as acrylamide. "Certainly they are used at safe levels, " Summerson said,
"but without any regulation, would this be true ? "
He said there is increasing concern about sensitizing chemicals, giving as
examples toluene diisocyanate and certain epoxy curing agents. "We have
objected to the use of these compounds even at levels below 0. 2% of the formu­
lation, " Summerson added. He also said it has been necessary to restrict
monomer content and low molecular weight functions for alkylphenolethylene
oxide condensate type emulsifiers. Summerson concluded:
"... with the ever increasing use of food packaging,
more and more segments of our population are exposed
to greater amounts of packaging chemicals. Some,
including babies, may have their entire diet exposed to
food packaging chemicals. Therefore, I believe . . .
ASI-PR 0000578
that industry and FDA must know the relative safety
of each migrant. "

s

(

February IS,

1968

Page 7
FOOD CHEMICAL NEW

Asked whether there is any evidence of migration of packaging components
greater than those presented by Frawley, Summerson said he does not know,
Frawiey said there is, but that most substances do not. Asked whether there
have been any two-year feeding studies that did not gibe with Frawley's, Summerson said there are "plenty" of them, but not necessarily on known packaging com­
ponents. Frawley said he concluded that except for pesticides and heavy metals,
no packaging materials are toxic at 40 p. p. m. or less. FDA's Dr. Joseph
McLaughlin, Jr., disagreed, pointing to acrylonitrile.
Summerson said that Frawley's sources "bias the data, " since highly-toxic
substances are not found in two-year studies, because the animals do not
survive for two years. He said some proposed additives never get to the twoyear testing stage. Frawley responded that because of a possible bias in the
data, he added an additional safety factor of ten.
FDA cannot set a "floor" simply because no problem has become apparent,
Summerson added.
Ramsey asked the industry representatives to put themselves in the place of
FDA-ers, asking: "... how would you exercise control? Would you take
your own advice and say we have gone much too far?"
He noted that the "world climate of toxicological opinion is extremely conserva­
tive, 11 saying that there is concern about "microinsults. "
Dr. Norton Nelson, of the New York University Medical Center, agreed that
"some simplification is required, " but warned against "over-simplification. "
He said "any single set of concentration limits" are not likely to be found.
Nelson said a cut-off point might work well for well-understood classes of
materials, but might not be adequate for others. He said he does not see how
FDA could "permit itself to become restricted" from dealing with new
compounds "in a rational way. "
Frawley noted the scientific support his proposal has received, particularly in
comments to FDA on its proposed food additive procedural regulations. Noting
that he made his proposal about 18 months ago, Frawley said, "... I have yet
to hear of a single commercial chemical which might be used in food packaging
which would be an exception. "
"This proposal has received overwhelming support from my profession, " the
toxicologist said, explaining that "24 other toxicologists from universities and
industries have supported this proposal in writing to the FDA" and "almost as
many others have privately supported it. " Stressing his finding that 0. 1 p.p. m.
should be the cut-off point for toxicological significance, Frawley said, "X believe
the body of scientific fact and opinion justifies immediate adoption of this concept
by FDA. "
"Several lawyers have advised me that this support from the scientific com­
munity of and by itself confirms that these uses are generally recognized as
ASI-PR 0000579

Page 8
February 19, 1968

FOOD CHEMICAL NEWS

safe . . . and that no action on the par; of the FDA is necessary, " Frawley
said, adding, "I will not enter into a legal debate on this premise, but I think
the evidence is clear that uses at or below this level of 0, 2% offer no significant
hazard to health ..."
Frawley's original proposal was based on the premise that migration at 0. 2%
or below will contribute migrants at tne pharmacologically insignificant level
of 0. 1 p. p. m. or less. He expanded the proposal last week to add that "major
components which can be shown by suitable migration studies to contribute no
more than 0. 1 p. p. m. to the diet should be considered nonmigratory. " He
explained:
"One additional guideline is needed to help prevent the
continued waste of effort and that is a level of migration
for components used at levels above 0. 2% which also can
be considered safe without toxicological studies. We frequently refer to this type of corrp onent as 'nonmigratory; '
It Is a logical extension of my previous proposal that we
adopt the same level of 0. 1 p. p. m. as a level of no
significant migration. If a use of a major component can
be confirmed by suitable analytical studies to contribute
no more than 0. 1 p. p. m., it should also be considered
safe. "

,

Frawley said that his 0. 2% dividing line "is unduly restrictive for most uses
of packaging components, " explaining that "many materials used at higher levels
in less permeable substrates than paper will contribute less than 0. 1 p. p. m. "
He said a "more limited study" of migration to food conducted with a radioactive
plasticizer used at 28% in polyvinyl chloride film suggested that "a 0. 6% level
of an additive in plastics will contribute no more than 0. 1 p.p, m. to the diet. "
Frawley added, "The data are insufficient for me to propose the adoption of
this dividing Line for plastics, but they clearly confirm that paper and rosin
size are a suitable choice as the extreme example of migration to food. " He
suggested that, "Perhaps some carefully directed research will permit estab­
lishing other dividing lines in the future. "
The Hercules scientist based his proposal on . two-year chronic toxicity tests
on 245 different substances, which he said constituted 90% of all such studies.
For °.ll but pesticides and heavy metals, he said, "every compound was without
toxic effect in experimental animals when fed for a lifetime at a dietary concen­
tration of 40 p. p. m. " Applying a 100-fold safety irargin, Frawley found that
every compound which has been studied is safe for man at a total dietary con­
centration of 1 p. p. m. " Because of possible bias in the cross-section of studies,
Frawley proposed "that we protect ourselves by adding another factor of ten
and adopt 0. 1 p. p. m. as a level of toxicological insignificance for all materials
other than pesticides and heavy metals. "
" . . . a compound which would be toxic to man at 0. 1 p. p. m. would have
revealed its extremely high toxicity in . . . (industrial) exposures and it would
v
have been rejected as incompatible for the food packaging industry, "‘ Frawley said.
He added that carcinogens are automatically barred under the Food Additive Law.
. ASI-PR 0000580

February 19,

1968

Page 9
FOOD CHEMICAL'X

Frawley said he studied paper coated with rosin size for extraction, and that the
studies demonstrated "that at a level of 1. 0% the maximum dietary contribution
will be 0. 5 p. p. m., and at a level of use of 0. 2% an insignificant amount of not
more than 0. 1 p. p. m. will be contributed to the diet. "

analytical techniques could be prescribed to set a practical standard for what
packaging material components must be regulated in the present sense? Can
this at least be done for broad categories of substances, leaving the others for
more concentrated scientific and regulatory attention?"
Stein,~Hall's Max Goldfrank, representing the Adhesives Manufacturers Associa­
tion, endorsed the Frawley proposal and said, "If thi^-doctrine is sound for foodcontact materials, as I believe it is, then it is even more valid for p.dhesives
components where there is substantially no chance of migration. "
1 P. P. M. Migration to Food or Solvents Suggested as Cut-off Point
■ Mobil Chemical's E, W. Erhardt and Continental Can's Dr. Robert Henry,
; representing the Can Manufacturers Institute, recommended that the cut-off
point for toxicological insignificance be 1 p. p. m. migrants in food or food( simulating solvent. Erhardt said this would be of the same "order of magniI tude" as Frawley's proposed .cut-off point of 0. 1 p.p. m. in the total diet.
Henry said, "The hundreds of extractability studies that have been performed
in the past 15 years have established the level of potential migration that has
proven to be without hazard, " adding that, "Before 1960 extractives of 1 p.p. m.
or less in accepted food-simulating solvents were considered by the FDA as
satisfactory evidence of safety in virtually all instances. " He said that "none of
the substances so cleared has presented any health problems. "
He urged that substances, except heavy metals, used in can manufacture which
migrate 1 p. p. m. or less in solvents be considered "generally recognized as
safe. " Henry also recommended that there should be a mechanism within FDA
"whereby a letter of concurrence with our conclusions can be obtained for those
customers who demand 'something from FDA,
Market Basket Surveys of Residues Urged
Monsanto's George W. Ingle, representing the Society of the Plastics Industry,
said "what is needed is ... to add the explicit phrase 'of toxicological signi­
ficance' to the statutory definition of food additive. " Such legislation, he said,
would "provide the conceptual basis for determining the requirements for Peti­
tioning and regulating these chemical compounds and uses within limits for which
it can be agreed that there is no toxicological significance. "
Saying there is a need to reliably correlate extraction figures with levels
actually in the diet, Ingle urged that FDA's market basket surveys of pesticide
residues be expanded "to include carefully selected indir ct additives in estabASI-PR 0000581

.

Page 10
February 19, 1968

(

(

FOOD CHEMICAL MEWS

lished uses. " He said other "simplifying improvements" could go forward, and
that the market basket analysis "should be considered as a continuing long-term
monitoring ..." From the resulting "representative levels, " Ingle said,
"order-of-magnituae categories could be established for many other additives,
if initial results justified. "
Ingle said that levels of migrants actually found in the total diet could be com­
pared "with those concentrations found to have detectable effects in . . • animal
feeding studies, " and that "this comparison would indicate where these human
dietary levels lie on the scale of toxicological significance. " He suggested that
this work be handled by a government-industry-university panel.
Noting Frawley's data on insignificant levels for paper containers, Ingle said
the approach he suggested could extend to other substrates. The data, he said
"would develop validated perspective as to which are toxicologically unimportant
sources of food additives" and "should end present confusion between chemical
compounds actually added to the food packaging material, and the specified chem­
ical compound, frequently an impurity or derivative, which alone may migrate
to food. "
Ingle concluded that, "... we could adopt the Frawley proposal and other
logical extensions of it to intelligently omit broad uses of chemical compounds
in packaging and other food contact material from the requirement for regulation. "
O
FDA-INDUSTRY INDIRECT ADDITIVES ADVISORY COMMITTEE URGED
Formation of a Food and Drug Administration-industry advisory committee to
tackle the problems of indirect additives was urged by virtually all industry
speakers at last week's FDA-sponsored conference on indirect additives in
Washington and in an industry letter to FDA Commissioner Goddard.
The suggestions for an advisory committee met the same kind of reluctance
from FDA spokesmen at the meeting that greeted proposals to exempt some
packaging materials from Petition requirements (See preceding story).
Eventually, agency spokesmen said they would both consider the proposal for
exemptions for some indirect additives and that they will relay the advisory
committee recommendation to the Commissioner's Office.
With interest in indirect additives being shown by a House Small Business
subcommittee, it appears that FDA may have to at least make the gesture of
forming an agency-industry committee to demonstrate good faith.
After initially expressing great doubt about an advisory committee, because
of conflict-of-interest considerations. Dr. William H. Summerson, director
of FDA's Bureau of Science, agreed to support the advisory committee recom­
mendation "to the extent it is feasible ..." He said he had intended to express
no objection to the formation of such a committee, but was only questioning
implementation of it. Summerson said he will ask Goddard to consider the

pr0p°sal-

ASI-PR 0000582

February 19, 1963

FOOD CHEMICAL 1

Summerson's qualified approval of the advisory committee idea came shortly
after Jerome H. Heckman, general counsel for the Society of the Plastics
Industry, accused FD^ of "negativism, " "... the only thing we have to fear
is FDA's fear, " Heckman commented.
An industry spokesman from the floor reflected the feeling that industry had
been allowed to come to the meeting and let off steam, but that the decisions
"had been made" by FDA in advance.
At the end of the first day of the meeting, Summerson asked industry to think
over the proposal for an advisory committee, asking, "How can it work out?"
He expressed concern about "conflict of interest" because the committee would
be made up of both the regulators and the regulated.
The next morning, conceding the existence of an 1962 Executive Or.$ier signed
by President Kennedy and authorizing advisory committees, Summerson stressed
that the Executive Order had emphasized freedom from conflict of interest.
He said he was involved with the use of advisory committees when he was at
the Army’s Edgewood Arsenal, and that advisory committees there were never
effective because of "conflict of interest. "
Summerson said that FDA does use advisory groups, but he said they may deal
only with technical points, since policy decisions must be made by the agency.
Industry spokesmen agreed that all decisions would have to be made by FDA's
front office.
However, the FDA-er said the concept of an industry-government group advising
what regulation of indirect additives should be like is "untenable. " "We couldn't
get away with it if we wanted to, " he commented. Summerson also expressed the
opinion that if there were such a committee - - limited to "technical points" - conflict of interest considerations would dictate that if a problem in the plastics
industry, for example, were discussed, the representative of that industry would
have to leave the room during the discussion and could not read the minutes.
Summerson's suggestion that any such committee should have representatives
of consumers on it, as well as government and industry representatives, was
readily accepted by industry spokesmen at the conference.
The FDA scientist added that "it depends upon the emotional climate at the time "
whether an advisory committee could be formed and how successful it would be.
Heckman said-that an advisory committee is clearly authorized by the Executive
Order, with FDA appointing a chairman, organizing the committee, and setting
up safeguards. He said this has been done by the Federal Communications Com­
mission. Heckman added that conflict of interest is a matter for lawyers to
discuss. B. F. Goodrich's William C. Becker, representing the Rubber Manu­
facturers Association, said there is no question of conflict of interest since
industry and FDA have a "common . . . interest in the consumer. "
ASI“PR 0000583

/

Page 12
February 19,

1968

FOOD CHEMICAL NEWS

Humble Oil and Refining's Dr. George W. Fiero, representing the American
Petroleum Institute, noted that the War Production Board during World War II,
of which he was a member, found industry advisory committee meetings "very
valuable. " Sun Oil's Dr. W. Wayne Stewart, also representing API, said the
Health, Education and Welfare Department's air pollution control group has an
industry advisory committee, stressing it is not a "liaison committee. " Stewart
said, "There are and can be formed advisory groups to regulatory agencies, "
adding that these can be used for development of "criteria" but not for "standards. "
New York University's Dr. Norton Nelson expressed the view that there would be
no conflict of interest, since differing interests should be represented.
Fred J. Delmore, director of FDA's Bureau of Voluntary Compliance, said he
could not "authorize an advisory committee, " but that BVC can offer a procedure
for setting up an "industry liaison committee. " He said there is precedent for
this. If industry should set up a liaison committee, Delmore said, BVC would
"welcome it. " He requested any such committee to tell him what areas are to
be discussed, and said he will then set up meetings. Delmore noted that an
industry liaison committee has developed specific "good manufacturing practice"
guidelines for a portion of the food industry and that these may eventually become
regulations (See story. Page 24).
The letter sent to Goddard, which noted the existence of Executive Order 11007,
said the indirect additive conference "cannot take the place of a round table
discussion between your scientists and administrators and their industry counter­
parts. " The letter, signed by American Paper Institute President Edwin A. Locke,
Jr., was on behalf of the Adhesives Manufacturers Association, American Paper
Institute, American Petroleum Institute, Can Manufacturers Association, Rubber
Manufacturers Association, Soap & Detergents Association, and Society of the
Plastics Industry.
Heckman stated the case for an advisory committee at the conference, in part
as follows:
"... the presently used regulatory approaches are so
inconsistent, so complex, and so virtually incomprehensible
to most of those in the regulated industry that anything short
of an in-depth reevaluation of the entire situation under
circumstances which allow for careful analysis, and the
development of detailed, comprehensive recommendations,
cannot bring about the type of reform so urgently needed.
"... unless this Conference is viewed as nothing more
than an organizational meeting, or an exercise in problem
identification, it could lead to superficial treatment of the
subject matter which might do more harm than good. "

ASI-PR 0000584
' s

f

Page 13
FOOD CHEMICAL N:

February 19, 1968

He recommended "that there be a government-industry cooperative effort
employing working committee techniques to analyze as many of the problems
as can be identified, and to develop carefully considered recommended solutions
for these problems on a joint basis, rather than through ex parte presentations
of the type being made here. "
O
FDA-ERS DENY CHANGE IN POLICY ON NO-EXTRACTIVE ADDITIVES
Food and Drug Administration representatives at last week's conference on
indirect additives in Washington denied that there had been any change in policy
towards indirect food additives for which tests show no extraction.
The agency has held since 1960 that if a manufacturer runs extractipn tests
on a packaging material and concludes the substance is not a "food additive"
the firm may take no further action unless it desires FDA concurrence. When
data showing the lack of extraction is presented to FDA, the agency holds that
a Food Additive Petition must be filed on the theory that the running of extrac­
tion tests presupposes the possibility of migration into food.
An FDA staff paper sent to the House Small Business Regulatory subcommittee
last month indicated that this policy had beei changed (See FOOD CHEMICAL
NEWS, Jan. 22, Page 21). The agency wrote: "Where FDA's review of the
proferred extraction studies confirms a lack of potential migration, no regu­
lation is necessary. "
FDA-ers indicated to FOOD CHEMICAL NEWS that the staff paper did in fact
confirm a policy change which had taken place about a year and a half before,
and that in some cases where the agency had confirmed lack of migration no
Petitions were required (See FOOD CHEMICAL NEWS, Feb. 5, Page 16).
However, FDA spokesmen at the conference last week said that there has been
no change in the policy, although they conceded that in some cases no Petition
is required.
It is apparent that there is a grey area here, and the number of substances allowed
to be marketed without clearance under a Food Additive Order has vaii ed over the
years. FDA-ers told FOOD CHEMICAL NEWS that it is a matter of "interpreta­
tion" rather than a matter of "policy. " It is believed that the "interpretation"
changed, at least for a while, and that FDA did give concurrence to no-migration
findings in at least a few cases.
Policy May Be Reappraised by FDA
However, the policy of not giving such concurrence in most cases is still in
effect. FDA-ers indicated that this policy might be reappraised as a result
of last week's conference.
ASI-PR 0000585

Page 14
February 19,

1968

FOOD CHEMICAL NEWS

When asked whether there was a change in policy, L. L. Ramsey, Assistant
Director of FDA's Bureau of Science for Regulatory Programs, said that if
there was a policy change "I am not aware of it. " "I don't know of any policy
change, " he added. He said that a manufacturer has the responsibility of
deciding whether a substance is a "food additive" "on his own. "
Asked whether FDA would confirm a finding of no extractives, as it did in 1959
and 1960, Ramsey pointed out that since 1960 the policy has been not to send
a letter of concurrence. The agency has stated, he explained, that if concur­
rence was needed, it would have to be via a Food Additive Order.
Ramsey conceded that there have been exceptions. He pointed out that it was
decided not to require clearance for catalysts, unless a firm desired clearance
and filed a Petition. He also said that in some cases, where the potential for
migration is "nil, " FDA has said a substance is not a "food additive" without
migration studies.
'
Dr. William H. Summerson, director of the Bureau of Science, added that "food
manufacturers can decide' for themselves that a substance is not a food additive
because of its lack of migration to food. " However, he said that "industry has
taken the position that they need FDA's concurrence and usually presents the
extraction data with a formal request for an opinion or a regulation. " Summerson
said that "usually this request requires concomitant toxicity data to show safety. "
The FDA scientist said, "Eventually requests for regulations through the Petition
method became the approach of industry for every substance which had even a
remote possibility of migrating into food. "
Advisory Opinions Urged
Jerome H. Heckman, general counsel for the Society of the Plastics Industry, asked
that an advisory committee (See preceding story) consider the questions: "Is it not
possible to enunciate better, more selective ground-rules on when Petitions are
really required, and what they should contain, by use of codified FDA rulings in
specific cases, and/or the issuance of Advisory Opinions which would help build
a coherent, understandable, and carefully rationalized body of law in these areas?"
B. F. Goodrich's William C. Becker, representing the Rubber Manufacturers
Association, said, "I recognize the difficulty that the FDA has in rendering
advisory opinions, but I would suggest that it is terribly difficult for industry
seeking to abide by the law to be told that it must make its own decision as to
the law's applicability in very difficult areas with the risk of seizure or prosecu­
tion if that decision is incorrect. "
Monsanto's George W. Ingle, representing the Society for the Plastics Industry,
expressed concern "with FDA's interpretation that the act of testing for extrac­
tion is, in itself, proof that migration of an indirect additive was reasonably
expected. " He called "this interpretation , . . totally unwarranted, " asking that
"quantitatively sound policy ... be established. "
ASI-PR 0000586

e
February 19,

Page 15
FOOD CHEMICAL NE'

1963

Stein, Hall's Max Goldfrank, representing the Adhesives Manufacturers Associ­
ation, recalled that during hearings on the Food Additive Law, Rep. Dingell
(D-Mich.) asked, "... would it be possible to obtain a statement from FDA
upon presentation of adequate facts to justify a conclusion that an adhesive is
or is r.ot a food additive, without going through the procedure . . . for filing a
Petition and getting it acted upon?" Goldfrank said that former FDA Deputy
Commissioner John L. Harvey wrote in response: "It is our view that under
the revised bill we would have authority to give advice of this type and it would
be our intent to do so. " Goldfrank commented that, "So far as I know, to this
day FDA has consistently refused to use this authority, "
O
COMMERCE PUTS HEAT ON INDUSTRY TO STANDARDIZE PACKAGE SIZES
The Department of Commerce has begun to put the heat on industry bo develop
voluntary standards of package sizes, and has bypassed the traditional route
through Washington's trade associations to high level company executives directly.
A half dozen meetings had been held with company presidents and board chairmen
in Washington, New York, and Chicago by last week, and others have been
scheduled.
Malcolm Jer.sen, who is director of Commerce's Office of Weights and Mea­
sures and also manager of Engineering Standards, was heading up a whirlwind
of activity aimed at getting industry cooperation with the Department's National
Bureau of Standards.
Commerce has been given responsibility under the Fair Packaging and Labeling
Act to determine whether the number of containers in which any given commodity
is packaged has proliferated to the extent that consumers cannot make effective
comparisons and value judgments.
Commerce issued regulations on how it would determine "undue proliferation, "
but has made no such citations, as they are called (See FOOD CHEMICAL NEWS,
July 31, Page 18).
A proposed revision of its product standardization rules has been sharply
criticized by industry (See FOOD CHEMICAL NEWS, Nov. 20, Page 8).
Commerce Release Cites Progress in Instant Coffee, Salad Oils
However, a press release issued Feb. 16 by Acting Secretary Howard J.
Samuels claimed credit for actions by two groups of food producers who he
said "are voluntarily reducing the number of containers in which their products
are packaged for retail sale. "
Some 50 other groups are in various stages of study in the Department, he con­
tinued, "aimed at similar reductions. "
ASI-pR
0000587

f

(
Amei'ican

Offiei «yikt pHHiUnt

aoo ma£>isoi4 iVExuis, Kitw youk, n. v, toots (ata) sae-saoo

February 9, 1968

Dr. James L. Goddard, Commissioner
Food and Drug Administration
Department of Health, Education,
2CG C Street, S.W,
Washington, D.C. 20204
Dear Dr. Goddard;
he industry groups named below welco,T.e your review of the approach to "indirect

food additives" (packaging materials, machinery
lubricants, etc.) under the Federal Food, Drug
and Cosmetic Act and the Conference which you
have called for February 13 and 14 at which they
and others will have an opportunity to express
views. They have requested and authorized me
to write you in their behalf.
They believe you will agree that however valuable the Conference will be, it cannot
take the place of round table discussion between
your scientists and administrators and their in­
dustry counterparts.
These organizations, which we believe
represent the industries filing most of the in­
direct additives petitions, respectfully suggest
that soon after the conclusion of the Conference
an "Industry-Government Advisory Committee" be

ASI-pft 0000588

' v>

*3*-

?y . .■

«

Dr. James L. Goddard, Commii._ioner

created along the lines envisaged by Executive
Order Number 11007 and in accordance with that
Order.
Such a committee would report its find­
ings and recommendations to you.
Sincerely,

EAL:al

Edwin A. Locke, Jr.
In behalf of:
Adhesive Mfrs. Ass'n. of America
American Paper Institute, Inc.
American Petroleum Institute
Can Manufacturers Institute
■>
Rubber Manufacturers Association
Soap & Detergent Association
Society of'the Plastics Industry

ASI-PR 0000589

j____ x

r

Hi____

2