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"“THE FOOD ADDHIV: riiOflLCi 0"
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MASTICS USED IN FOOD PACKAGING*
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L. L. Ramsey
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Assistant Director for Regulatory Programs
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Bureau of Science
Food end Drug Administration
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Consumer Protection and Environmental Health Service
• TilS, DHEW
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X welcome the opportunity hero this afternoon to rervicnr with

yoi\ nose of the regulatory developments in the area of indirect.: £c:.a
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Additives, which, of course* include the migrat ■. / substances
pled 'em used in food packaging, 1

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’ In response to industry'o rieed we developed and issued a dcau:.\'z
in August 1.9GS entitled MFDA Guidelines for Chcmiatry and Technology
Requirementr of Foy3 Additive^Petitions,M
with it.

You ore undoubtedly familiar

The purpose of this' document wao to elaborate and clarify

the regulations with respect to the chemistry and technology darn
T.'equircd for the /eleorance fof not only direct food additives but also
indirect food additives..

JChe document, itself, mode it clear that it

was not to be construed of n regulation, that it oet forth guidelines,
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not inflexible .'requirements,
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In the Federal Register of August 0, 196/, FDA published a nropcsbl

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to reviGc its procedural regulations for food additive petitions.
from this publication

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Quoting

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•*For presentation at the National Technical Conference of the Society of
Plactico Engineers, November 4-6, 1909, Dallas, Texas,

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"Xho Commissioner Jf Food and Drugs proponco that the pre.r,.
food additive regulations be revised as act forth below to obt! in
improvement in the quality end organization of food additive p e‘; it fens

A'/W.M.'-'I ml I'j t't.ytpI U‘ IheJ.t? Htbntifjy: rirvl'V by tl>cr V006 and I)ft!-:'
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Administration. The/need for ouch revision io based on the following:
------------- ..all
A.. /Almost
hnl,iof
of the food edditivo petitions as originally

:cd **-’
-- Drug Administration have been incomplete or
eubmittdd
to the ''i-J
Ebad and
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have not adequately supported the regulation requested and, therefore,
havexrcquircd subsequent supplementation, amendment, withdrawal, or

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Scientific review of deficient and poorly organised petitions
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■ io tn unnecessary burden that wastes the time nnd efforts of both
Administration and industry acientistn.” *

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This proposal prescribes the format and content of the petition
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and its organisation in greater detail than previously, requires
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odequatc indexing, and requires a oumaary of tho petition.

We received

53 communications, including one from the Society of Plastics Industry,
commenting upon this proposal.

Some of these communications were rather

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voluminousi the opposing point of view boing argued in detail and at
some lengtk. Three major issues were evident from these comments:
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I. whether the analytical method end a aummary of the toxi­

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cological information upon which a regulation has issued can properly
be conc/dcred public information,

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Whether it is proper to require that 10 year old data 6r
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older must be resubmitted.

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ASI 00001182

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to listen, to obtain your vicwc'T.Trd recommendations (1) with rc^'.'h to
poooiblc changes that caa.be made in FDA petition requirements r:.i i:
criteria for evaluating the oafety of the indirect additives frer; for '
packaging materials and food processing equipment, and (2) with rogev:!
to any po33lble changes in the ocientific or administrative handling
of. this whole area of indirect food additives.

Vo cannot, of course-

accept ony recommendations which sacrifice the consumer protection
afforded by the Food Additives Amendment against unsafe amounts of
foreign oubstanccs in the country's food su, ply.
the

And perhaps this la

of the whole problem, he**; much of a health risk chould the

conssrmer bo ■subjected to, for the risk from indirect food cddifciv
however alight, cannot be summarily dismissed; it is merely a matter
of degreo. . Absolute safety, like the absolute zero, can nevar be
uneiuivocally demonstrated although in many instances it can be approached
ever

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closely.

t,Te are indeed hopeful that we chall receive ocma

practical and epecifia suggestions during this conference, suggestions
that are both scientifically and administratively sound."

At this conference, Lr. Frnwley reiterated his proposal as follows:
"Thus, we propose three categories of food packaging components:
1) the;a used at 0.27* or less which cannot ’reasonably be expected' to

nbove 0.2% which rny 'reasonably be expected* to become a component of
food, 'but in fact do not,' and these oliould be considered nor.mlgrntcry,
and 3) those used above 0,27. which are indeed food additivco ancj should
Is subject to appropriate exami-----t'-\ lart."

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Y,ucthcr it~ls proper t'6 Yfequiro dctoilo of-thc menufact

/procesa for every additive.

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Iriyoddition end aside from tho procedural regulations the S.'/.ci ■
of ndctics Industry ceiled upon this opportunity to recocted c
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major chance in the handling of indirect food additive petitions in­
volving traco amounto of food additives.

Pointing to a paper presented

by I?r. John P. Frawlcy at the notional meeting of the American Chemical
Society in Hew York, September 1966, tho SPI objected atrongly to the
need for migration' and toxicology studies where the usage level of a
eubato^no in the packaging material waa leca than 0,27,, with certain
exceptions.

About this tine, tho dissatisfaction of a part of the

food packaging

.’ustry with FDA's requirement?' for clearance of in­

direct ft od additives also came to the attention of a congressional
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committee.

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In order to provide an opportunity for the industry and other
interested groups to review and discuss with FDA the scientific basis
for its policy with respect to indirect food additives, the FDA scheduled
a National Conference on Indirect Food Additives,

Thio conference was

h^ld in Washington, D, C., on February 13-14, 1968. It was well attended
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arid while representatives of your organization did not appear on tho
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prrogrea, I believe your Industry was well represented by speakers for ■
Tire Society of the Plastics Industry, Inc,

The representatives from

FL'A explained our present policy and reviewed the scientific basis for
it.

They made it clear, however, that FDA came primarily Decking

information and advice.
con-

Quoting from the paper I presented;

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union. I would only remind you that ye in the FDA nro hero primarily O

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llo explained further that VTcvol of 0,27. or "loco of o co;'—

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in the packaging material'or in the food contact surface would r.c
bo expected to contribute core than 0,1 ppn of on individual cuV
to the total diet of nan and ha recorded thio os inoignifleant
toxicologically,

lie 'would exclude heavy netals end pesticides, hc.:-

e'fcr, from this concept of safety at 0,1 ppm.

Tho industry speakers at the conference generally endorsed the
essence of Dr. Frawley’s proposal.

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Following this national conference wo in FDA undertook a renppraioal
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of our requirements and procedures for the indirect food additives in
light o.f the recommendations and suggestions of industry and in light
of our own experience during a dorado of administration of tho "cod
Additives Ancni’ment.
an-1,

Thi3 reappraisal was initiated to deter, ina whe '.her

changes should be made.

■While our own study vac underway v?e were inforaed that a task force
on Toxicologic Insignificance had been established by the Food Protection
Committee of tho Food and Nutrition Board., HAS-NkC, to study the broad
problem of the safety,of minute amounts of substances in Dan’s diet.
The 1IAS-MRC report entitled "G

nes for Estimating Toxicologically

Insignificant Levels of Chemie

Food" is the result of this, study

and has Just been published.

ayed the development of any proposal

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bis report,

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risked n prn-publication copy

However, we were fur-

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Academy on a confidential basis

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oc’vcral month:} ago and used it au me development of an in-house (Bureau
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0ji Science) proposal. A draft of thio proposal was oent to the industries

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represented at L\national Conference for corr/ent and for dir' .
with us.

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Wc concluded Chore discussions on the prop ml with the

industry thia past September.
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Thia in-house proposal vould amend tho regulations to permit the
use of oubrtancoa (except heavy metals* carcinogens, and other substances
that haVQ been demonstrated to produce toxic reactions when preaerp. at
Zcvelt of 40 ppm. or lesa in the diet of can or animals) in food pr.ch.-^inj
paterialo and other food contact curface3 no followsj

(1)

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As component*! of food-contact artic.lea provided any substance

co tee a contributes no more than 0.05 ppza to tho contacted food;
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As components of articles for use in contact with dry, non-

£ot.ty £ -ad;
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As components of articles/ intended for repented use in

Contact with bull*, quantities ofI fqod,
food.
(4)

Ao components of dcfor.n'ing agents employe
_*cd in tho manufacture

of paper and paperboard intended
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in contact with food.
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As components of food-packaging adhesives.

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We have not yet reached a decision on whether or not to publish

the proposal formally in the/Federal Regia Cor; and, of course* I ca
unable to make any reliable/prediction in this regard.

We do intend to finalize a revision of the food additive procedural
regulations mentioned earlier, and we expect to adopt none of the
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»uggcotion3 received which we have evaluated and found to be round.

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Let* a turn out attention-asy_to the'processing of food add.'
petitions.

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In finite of the Guidelines and tlic propoccd rcviiiie;i o'

the procedural regulations, we continue to recoivc a high percentage
of deficient petitions./ Tho Root/con’-T.en deficiency io a leek of’
adequate extraction-daLa from which to estimate the likely mi oration
off packaging componen/c to food/ Another common deficiency io q

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failure to identify fully the proposed packaging component by ita
Chemical Abctrnctn name and by physical and chemical specifications.
Identity io, an you undoubtedly appreciate, baoic to our consideration
Vo aloo urge you to provide/n general summary of any petition you subm
which will includa among otner things the following:
tho' expected ~
quantity of the^food additive in individual foods or classes of feeds

under tho proposed conditions of use, the maximum as well as the
overage quantity to be expected,ir the total daily diet of the con­
ic/ margin of/anfety
suraer, and the ciargi
ifety provided by the animal feeding studies
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The submission of an inadequate petition imposes en unnecessary
burden upon our scientific Btaff ond more importantly from your view­
point rcsulto in costly delays in time for you,

I would urgo you to

mnko every effort to /assure yourself that the petition you submit io
■indeed fully supported by the necessary data and information when it
is submitted.
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About one half of all food additive petitions received nre in the
indirect area.

/During the period July 1, I960, to June 30, 1969, we

received a total of 121 food odditivo petitions; Cl of these wci'e for
indirect additives.

The rcccipto of petitions oince last June qrc

continuing nt/about tho same rate.
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Currently, v/i'th only on occasional exception, feed, addin;
ore beinj handled within the otatutory time limito.

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Thio worh :.r. recorded

high priority and we expect to maintain thia level of performance irA t’< 0
future. Your cooperation in observing the Guidelines and the ru^ul.at.’.ons

in preparing

g6und,

well organized food additive petitions will help

ocoura tho realization of on important mutual coal of Industry and IDA,
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the prompt prpeasring of the petitions.- .

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