THE REGULATORY CONTROL OF PLASTIC FOOD-PACKAGING

‘ ' MATERIALS IN THE UNITED STATES

by
William F. Randolph
Petitions,Control Branch, Bureau of Science
a,
Food and Drug Administration
Consumer ProtectiQn and Environmental Health Service
’Public Health Service
U.S, Department of Health, Education, & Welfare
Washington, D. C.

■The Food and Drug Administration has great respect for the
excellent worR of the pan American Health Organization in combating
»*«
disease and promoting the health of the people of the Western Hemisphere.
We are indeed honored to be invited to participate in this 5th Annual
Seminar on Food and Drug Control

and to discuss with you our regulatory

control of plastic materials intended for use in contact with food.
We currently exercise control over such plastics under the pro­
visions of the 1958 Food Additives Amendment to the U.S. Federal Food,
Drug, and Cosmetic Act.
the Pesticide:

This food protection amendment, together with

Chemicals Amendment of 1954 and the Color Additives Amendmo-

of ,1960, greatly strengthened our law to help us better protect the consumer
against unsafe substances in his food supply.

These three amendments have

been well characterized as pretesting* preclearance amendments.

In general,

o

they require proof of safdty and government clearance before any new
chemicals can be added to food.

For presentation at the World Health Qrganizatio'n/pan American Health
Organization 5th Annual Seminar on Food and Drug Control for Central
America and panama, May 26-31, 1969, Managua, Nicaragua.

ASI 00000638

5

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Although the term "food additive" is of relatively recent orlg:‘

the addition of chemicals to food is a very old practice which probably
i

*'*'

began when man first learned to preserve meat by putting salt on it.
Since that time, the science of food chemistry has made tremendous progress,
particularly since the turn of the century.

Today, a great many chalice'

substances are being safely employed to make food more attractive, better
|

tasting, and more economical. The gro'wing^processing, and packaging pZ
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1
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food so that it can be transported for thousands of miles and remain in
|

good condition for months or even years is truly one of the outstanding
i
achievements of our time. However, during Congressional hearings in the
i

middle and late 1950's, a consensus of expert opinion established that
a number of these chemicals being used in foods had not been adequately
tested for safety.

Although most manufacturers made tests and consulted

with FDA concerning the safety of their products, not all of them did nor
Jere they required to do^ so.

It became increasingly clear that our- lav;

j

had to be changed to prevent the addition to food of unsafe chemicals.
'

Under the Federal Food, Drug, and cSsmetic Act of 1938, as it was
i!
prior to September 1958, FDA,-could not prevent the use of a chemical additive
|
I
simply because it was questionable or had hot been adequately tested.
It
i
was necessary to be able to prove the chemical additive was poisonous or
deleterious.

This was not difficult to prove in the case of chemicals that

cause immediate or acute illness; however, scientists were concerned with
the long-term effects of exposure to minute amounts of chemicals over a

- 2 ASI 00000639

period of years or even a life time, and proving a chemical to be
poisonous or deleterious under these circumstances may be very difficult.
Often several years of feeding tests on different kinds of animals may
be required to determine the chronic effects resulting from Che addition
of small amount? of chemicglp to the dietj

i

From 1950 to 1958 U. S. Congressional Committees intensively
studied the problem of, how to protect the consumer from inadequately tc-si^d
food additives.

The culmination of these s|udies was the enactment of the
i

Food Additives Amendment in September 1958. | This Amendment was one of
the pioneer statutes recognizing the need fir control of potential en­
vironmental hazards.

It provides for the control of food additives, whether

they are added directly and intentionally to food to accomplish a particular
technical effect or whether they become a component of food indirec-tly
through migration from food-packaging materials or other sources such as
food-processing equipment and machinery.
For purposes of the Food Additives Amendment, the term "food
additive" means any substance the intended use of which results or may
reasonably be expected to result^directly or indirectly, in its becoming
a component or otherwise affecting the characteristics of any food subject
to certain specified exemptions.

The amendment specifically includes "any

substance intended for use in producing, manufacturing, packing,

pro­

cessing, preparing, treating, packaging, transporting, or holding food;
and including any source of radiation intended for any such use,"

Under

3 ASI 00000640

the amendment the term "food additive" does not include the following,
i

exempted substances:

(1)

substances recognized by appropriately qur,li-f->ed

experts as being safe for their intended use, (2) substances used in ac­
cordance with a sanction or approval granted prior to September 6, lfk
i
'
under the Federal Food, Drug, and Cosmetic Act, the Meat Inspection Act,
or the Poultry Products Inspection Act; however, such exemptions ore
limited to the specific uses for which th'c sanctions were given,

(3)

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*

pesticide chemicals used under the provisions of the pesticide Chemicals
i
Amendment to the Act, and (4) color additives used under the provisions
i

of the Color Additives Amendment to the Act,

The law specifies that a

t
food additive is deemed to be unsafe unless its use is subject to an
exemption or unless it is used in accordance with a food additive regu­
lation prescribing safe conditions of use.

It establishes a procedure

whereby a person v?ishing to use a food additive may petition for a regu­
lation for such use by demonstrating that it is, in fact, safe for its

j:
intended use.
.

:

When the Food Additives Amendment was passed in 1958, plastics
t

i

and other materials intended for use in contact with food became a matter
<j>f increased interest to the Food and Drug Administration.

Basic materials

I.
'
‘
required study to determine whether they would migrate to food in sufficient
quantity to be hazardous to the consumer.

Similar studies were also

necessary on the adjuvants, such as stabilizers, plasticizers, etc.., needed
to make the basic materials functional.

All had to be considered under

the Act and their use as food additives required regulation prescribing
b
safe conditions of use,

)

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ASI 00000641

;
The following discus'sion will beiimited to plastics and their
I
■
adjuvants that have been regulated or otherwise permitted for use in
i
contact with food under the provisions of our Food Additives Amendment,
It provides a summary of materials under regulation;

Complete details

i

can be obtained by consulting the cited references which include inf on r.tion
?
3
on any usage restrictions or other limitations considered necessary t-o
assure safe use'of the additives.

These references refer to the appropriate

^ijetion of the U. S, food additive regulations which are found under ^
Title 21 of our Code of Federal Regulations.

J

In the ten years we have been regulating food additives, we have

issued a number of regulations to provide for the use of many synthetic
polymers and their adjuvants in contact with food.
be divided into thr.ee groups:

These regulations may

those dealing with the basic synthetic

polymer (Table 1); compositions containing synthetic polymers (Table 2),
1nd adjuvant materials used with synthetic polymers (Table 3).

5 -

}

ASI 00000642

TABLE 1—SYNTHETIC POLYMERS REGULATED AS INDIRECT FOOD ADDITIVES

(Reference)
Acrylamide-acrylic acid resins

121.2512

Acrylate ester copolymer coatings
i

121.2525

Acrylic and modified acrylic plastics,
| semirigid and rigid.

121.2591

Chlorinated polycthcr resins

121.2581

1,4-Cyclohexylene dimcthylene terephthald'te*and
'4-cyclohoxylene dimethylane dsophthnlate
copolymer

121.2533

Ethylene-ocrylic. acid

121.2564

Ethylene-ethyl acrylate copolymers

121.2554

Ethylene-methacrylic acid copolymers, ethylenemethacrylic acid-viny(l acetate copolymers,
and their partial salts

121.2582

Ethylene-methyl acrylate copolymers

121.2528

i
Ethylean-vinyl acetate copolymers
l!
F luoroesrbon resins

J

121.2570
121.2523

.

Hydro.eyethy1 cellulose, water insoluble film

121.2567

Isobutylene polymers

121.2590

4,4'-Isopropylidcnedj phenol-opichlorohydrin
| resins, minimum molecular weight 10,000

121.2579

4,41-Isopropylidenediphenol-epichlorbhydrin,
i thermosetting 'epoxy resins
;
7
Melamine-formaldehyde resins in molded articles
Nylon resins
'
/

121,2585
121.2569
121.2502

Olefin polymers

j

121.2501

Partial phosphoric acid esters of polyester resins

121.2601

Ferfluorocarbon resins

121.2555

Phenolic resins in molded articles

121.2587

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ASX 00000643

Table 1 (cont'd)
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Polycarbonate resins

(Reference)
121.2574

Poly (2,6-dimethyl** 1,4-phenylene) oxide resins

121.2603

Polyester resins, cross-linked

121.2576

!

'

*

Polyethylene

121.2501

Polyethylene, chlorinated

121.2532

j

polyethylene, oxidized
j\

121.2517

■

...

Polyethylene resins, carboxy modified

121.2530

Polymer modifiers in semirigid and rigid
polyvinyl chloride

121.2597
121.2501

poly(methylpentene)
|
Polypropylene
!

I

121.2501.

I

121.2510

Polystyrene and rubber-modified polystyrene
*
Polysulfide polymer-polyepoxy resins
Polyurethane
Polyvinyl alcohol film

i

■

_

-

*
121.2572
f

121.2522

[

121.2593

I

jolyvinylidene fluoride resins

121.2593

Styrene-divinylbenzene copolymers

121.2584

jJrea-formaldehyde resins in molded articles

121.2595

Vinyl acetate-crotonic acid copolymers

121.2540

Vinyl chloride-ethylene copolymers

121.2609

1 t

■

Vinyl chloride-propylene copolymers

121.2521

Vinylidene chloride copolymer coatings for
nylon film

121.2599

Vinylidene chloride copolymer coatings for
polycarbonate film

121.2600

Vinyl chloride-lauryl vinyl ether copolymers

121.2608

\yle:.e-iormaiaunyac resms ccnc.enscd uitn
4,41-isopropylidencdiphenol-epichlorohydrin
epoxy resins

1-21.2559

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ASI 00000644

A.

*

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TABLE 2--MATERIALS CONTAINING SYNTHETIC POLYMERS REGULATED AS
1
INDIRECT FOOD ADDITIVES

Adhesives

(Reference)
121.2520

c*.

Cellophane

121.2507

Closures with sealing, gaskets for food containers

121.2550

Components of pap'er and paperboard in contact ,
with aqueous ' and fatty foods

121.2526

Components of paper and paperboard in contact
with dry food
'

121*2571

filters, resin-bonded

121.2536

Hot-melt strippable food coatings

121.2578

Lubricants with incidental food contact

121.2553

d

i

Packaging materials for use during the
irradiation of prepackaged foods
Polyethylene terephthalate film
1
Pres sure -sens! tivc ridheflivcs

121.2543
121.2524
f

i
i

121.2577

Reinforced wax

121.2530

Resinous and polymeric.coatings

121.2514

Resinous and polymeric coatings for polyolefin
films
'

121.2569

<
Rubber articles intended for repeated use

121.25C2

1

i
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Surface lubricants used in the manufacture of
metal articles

.

121.2531

Textiles and textile fibers

121.2535

Textryls

121.2545

- 8 -

00000645
ASI OOOC

TABLE 3--ADJUVANTS FOR' SYNTHETIC POLYMERS. REGULATED AS
‘
, INDIRECT FOOD ADDITIVES

Adjuvant substances used in the manufacture of
foamed polystyrene

(Reference)

Antioxidants at d/or stabilizers for polymers

121,2560

Antistatic and/or antifogging agent in food­
packaging materials

121.2527

Emulsifiers and/or surface-active agents

121.2541

.Emulsifiers used in the manufacture of
coatings for paper and paperboard

121.2521

4-Kydroxymethyl-2,6-dj-tert-butylbhenol

121.2508

Octyltin stabilizers in polyvinyl chloride
p 1astic s
I
I
plasticizers for polymeric materials

121.2602
121.2511

polyhydric. alcohol diesters of oxidatively
refined (Gersthoffen' process) montan wax acids

121.2605

Release agents

121.2509

Ultramarine blue

.■

,

^
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!

121.2583

121.2563

- 9

ASI

00000646

h

In addition to these regulated additives, there are a number
of synthetic polymers and their adjuvant^ that may be used in contact
with food in accordance with sanctions or approvals granted prior to
passage of the Food Additives Amendment.

Section 121.2001 of the food

additive regulations contains a partial listing of substances, including
i,

a number of synthetic polyme£-/adjuvants,, that are prior sanctioned for
' ,

/

use in the manufacture of food-packaging materials.

In addition to

‘substances listed in section 121.2001, FDA recognizes a prior sanction
for all food-packaging applications for polyvinyl chloride basic resins
that have a maximal volatility of not over, 3.0- percent when heated for
one hour at 105° C. and that have an inherent viscosity of not less than
0.35, as determined by ASDM D 1243-60, Method A.
In addition Table 4
I
contains a list of other synthetic polymers for which prior sanctions have
been granted for use as films for food-contact use.

1

- 10-

ASI 00000647

TABLE 4—SYNTHElxC POLYMERS FOR WHICH PRIOR SANCTIONS HAVE BE.:
I
GRAFTED FOR USE AS FILMS
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*
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Acrylonitrile-butadiene-styrene copolymers
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Butadiene-acrylonitrile copolymers
]

Cellulose acetate '
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Ethyl cellulose.
j
Polyester-ethylene terephthalate and ethylene isophthalate
Pplyethyl acrylate
Polytaethyl acrylate
pblyvinyl chloride-acetate
'T \ hes«
(-.eh-imi

e»-\\

by

crvh C-I*

?
)

1

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ASI 0000064S

There are elso a few synthetic,polymers that are generally
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jrecogniaed as safe for their intended use as listed in Section 121,103
:of the food additive■regulations. Table 5 contains the synthetic poly, ;rs
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in that list. The methyl cellulose and sodium carboxymethyl cellulose

j

ml'

Trust be the grades specified for direct food use.

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ASI 00000649

/

TABLE 5--SYNTHETIC POLYMERS GENERALLY.RECOGNIZED AS SAFE FOR THE
INTENDED PURPOSE
/

Direct Food Additives:
Methyl cellulose /
Sodium carboxymethyl cellulose
l
Substances Migrating from Paper and paperboard:.
Cellulose acetate
Ethyl acrylate
Ethyl cellulose
Methyl acrylate

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ASI 00000650

Section 121.2500 of the food additive, regulations defines good
manufacturing practice for additives regulated for food packaging use.
the
This regulation includea^provision that substances used as components of
«
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*
,
food-contact articles shall be of a purity suitable for their intended
use and further stipulates■ t^hat. regulated) packaging-materials shall not
impart odor or taste to any food product such as to render it unfit for
use within the meaning'of the Act.
Basic polymers that are permitted f^>r use in contact with food
under the provisions of the food Additives iimendment, may be mixed with
each other provided there is no chemical reaction between the component

a.

p r.

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V,
of the mix.

In such cases, the most restrictive use limitation applies

to the mixture.

For example, polyurethane resins are limited to use with

dry bulk foods only, so mixtures containing these resins would be subject
to the same limitation.

The adjuvants, limited according to their regu­

lations, may also be used in mixture with other basic polymers.

Other

adjuvants listed in the prior sanction list may also be mixed x^ith regulated
synthetic polymers.
Certain of the regulations -- most of those in Table 2 -- cover
a wide variety of synthetic polymers.

The appearance of the material in

these regulations does not indicate safety for all uses, but only for
those specified.

For example, Section 121.2520 of .the food additive regu­

lations (Adhesives) is written to.minimize the contact between food and
adhesives.

With such use restrictions, m^ny components are listed in this

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ASI 00000651

regulation as safe only because migration to food will be toxicologically
I ■
insignificant. Similarly, some of the substances listed in certain othei
regulations have been established as safe only under the specified conditions

i

.;

As part of a continuing effort to improve administration of the

i

’

provisions of the Food Additives Amendment, the Food and Drug Administration
■
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conducted a National Conference on Indirect Food Additives on February

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13-14, 1968,in Washington, D. C. • One of the objectives of the confe^enc,
was to seek the advice of the scientific community on the adequacy and
appropriateness of the Food and Drug Administration's scientific policies
i '
concerning control and regulation of the so-called "incidental additives"

i

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that become a component of food indirectly through migration from food­
packaging materials or other sources such as food processing equipment and
nachindry,

A major controversial issue discussed at that conference is

whether all of the requirements of food additive petitions for indirect
rood additives are actually necessary.
1

Many of the industries represented

a|t that conference endorsed' the opinion of Dr. John p. Frawley of Hercules,
j

1

Inc., first expressed in a paper delivered before the American’Chemical
sjociety in New York on December 14, 1966, and reiterated on a number of
I; ■
occasions subsequently.

Dr. Frawley holds that any substance (axcept

pesticides, heavy metals, and carcinogens) which is suitable for use as
J'functional component in a food package or container, at a level of 0,2
percent of less, cannot become a component of food at an unsafe level and
i
hence toxicology studies or Migration studies need not be required.

-15 -

ASI 00000652

Dr. Frawley cqnten^s'that it is a waste of our scientific ^sources to
utilize them on' packaging problems in such cases because they can be of
no possible health significance.
Although we have b$en unable to accept Dr. Frawley's proposal
completely, wo arc presently considering proposing amendment of our
food additive regulations to establish additional broad categories of
substances that under conditions of good manufacturing practice may be
i

safely used as components of articles that contact food.

Under the

j

contemplated conditions of use, we would not expect these additional
substances to become components of food in any toxicologically significant
k

amounts.

1

In this connection we are considering proposing amendment of

our food additive regulations to permit substances (except carcinogens,
heavy metals, and any other substances that have been demonstrated -to
produce toxic reactions when present at levels at 40 parts per million
or less in the diet of men or animals) to be used under any one of the
following conditions;

(1)

as components of food-contact articles, provided

any substance so used contributes no more than 0.05 part per million of
■ I
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additives to the contacted food as determined by analysis of the food, or
by appropriate extraction studies, or by calculations assuming 100 percent
migration; (2)

as components of articles intended for use in contact with
9
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dry foods with surfaces containing no free jfat or oil, provided the finished
1
food-contact surface contains no free oils kot otherwise permitted for
such use; (3)

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

- 16 -

ASI 00000653

with food;
.

(4) as components of defoaming agents employe

prior to

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or during the sheet-forming operation in the manufacture of paper and

.

paperboard intended for use in contact with food; and (5) as component:
of ,food-,packaging adhesives used under conditions precluding any significant
;
*
migration of adhesive to food,
A preliminary draft of our proposal was sent early this month

r.

o representatives of the various industry trade associations which took

part in our 1968 FDA-Industry Conference on Indirect Additives.
„ I

We*have

|

asked these affected industries to express their views on our proposal
Which we believe would simplify and improve our indirect food additive
i
i
Regulatory process Without' in any way jeopardizing public safety.
There 'are, of course, still a number of synthetic polymers and
Synthetic polymer adjuvants that could be used in food-packaging applications
which
j ^arc not yet covered by our regulations.

In addition, interest has

bjeen expressed in obtaining clearance for additional food-packaging uses

j1

for a number of the presently regulated synthetic polymers and their
adjuvants.

Last year we received an average of six new food additivp

petitions each month requesting regulations for food-packaging applications,
i
Juaxnly involving synthetic polymers and their adjuvants.
Section 121.51
I'
**
bf the food additive regulations details the procedures to be followed in
:ion, I have available for dispreparing such petitions.
In this connect!
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tribution copies of our "FDA Guideline for Chemistry and Technology
Requirements of Food Additive Petitions.'1 'These guidelines reflect our
views with respect to the type of data and other information needed for

-1,7-

ASI 00000654

making an intelligent and*informed evaluation of a food additive
petition in thq area pfrchemistry technology.

These guidelines suggest

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ways to conduct:'', extraction studies to determine what and how much of any
indirect food additives can be expected to migrate from food-packaging
materials and food-processing equipment to individual foods or classes
i
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of foods under the proposed conditions of "use. We find' that extraction
or migration sLudies for plastics and other food-packaging materials are
‘
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v
usually required to provide a sound basis for assessing the safety of
their use.

Before the toxicologist can give purposeful attention, to tf-je

appraisal of the safety of any substance in food, it is essential that
be know the nature and the amount of the substance expected to migrate
to the food as a result of the proposed use.

Without this information we

are unable to comment regarding what additional toxicity studies, 'if any,
may be necessary for the purpose of a petition.

It is also necessary to

consider the extent to which a new food-packaging material is likely to
be used.

As Indicated in Table 6, polyethylene and cellophane presently

account for approximately 80% of all food-f»ackaging films used in the
United States.

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As
ASI 00000655

TABLE 6 — H1LLI0NS OF POUNDS OF FOOD-PACKAGING FILM USED IN VUE U.S.A,
I
1966_____________
1967 1968
!
i
(%)
(%)
(/
Polyethylene
360
(47.3)
365
(46.9)
395
(47.6)
1
i .
Cellophane
296
(39.0)
285 ‘ (36.6)
280
(33,8)
■
2
polyvinyl chloride
■
,
2
Polypropylene
,
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j
Polyvinylidene chloride
19
Polystyrene
.i
1
7
Polyester
i
o
Rubber hydrochloride
Cellulose acetate^
2

A 11 others (including
nylon, fluorocarbon,
polyvinyl alcohol,
polycarbonate, etc.)

'

!
T OTAL

28

( 3,7)

49

( 6.3)

63

31.5

( 4.1)

35

< 4.5)

45.5 ^ 5.5)

14

( 1.8)

14

< 1.8)

7.7

( i.o)

5.is

( 0.7)

‘ 10.5

C 1.4)

3.5

( 0.5)

«

3.5

•
'
,

15.4

( 1.9)

8.4 < 1.1)

9.1

'( 1.1)

5.6 ( 0.7)

' 5.6

( t-.7,

( 0.9)

4.9

( 0.6)

(0.5)

3.5

( 0.4)

( 0.7)

7

( 0.8)

. 7
3.5

f

( 0.5)

( 7.6)

.

,.s

/

760.3

(100)

778.1

(100)

829

(100)

Industry estimates as reported in Modern packaging Encyclopedia (1968 Edition)
Estimated maximum calculated at 70% total production for this type of
film as reported.in Modern packaging Encyclopedia (1968 Edition)

i
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ASI 00000656

In conclu

ng my remarks, I would like to ,oint out to

mu

that there is no authority under the .Food Additives Amendment for our
|
individual*
'Japproval" of A proprietary products. We have no control over the dayI
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'
to-day formulation of proprietary products and the responsibility for
compliance with the requirements of the Food Additives Amendment to our
j

Act must in all cases fall upon the manufacturer.

We do, however,

routinely offer informal comment regarding the food additive status of
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constituents in formulations when we are furnished quantitative formulas.
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Anyone desiring advisory assistance or information concerning the status
•!
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of his products under the Federal Food, Drug, and Cosmetic Act is invited
to contact the Bureau ofi
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■

Compliance, Division of Case Guidance,

Food and Drug Administration, Consumer protection add Environmental Health
Service, Public Health Service, U. S. Departnent of Health, Education,
and Welfare, Washington, D, C. 20204.

Requests for such advisory opinions

should give the essential facts and details of the inquiry, including, when
applicable, a complete description of the pfoduct and its intended use.
If desired, interested parties may also obtain through our Bureau of
Compliance reprints of the food additive and other FDA regulations
that are published in the FEDERAL REGISTER,

If desired, we will also add

tjheir names to our mailing list so that they receive future reprints of
changes to these regulations.

There is no charge for this service.

In this brief and general discussion of our regulatory program, I
have passed quickly over many important parts and will be glad to attempt
to answer any questions you may have.

In closing, I want to thank you

again for your invitation to participate in the Seminar and for your
i
attention.

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ASI 00000657