Industrial ChamIcals

Industrial Chemicals

Res. Alikin.MtL

Research - MRL

Dr. E. p. Aik—n

Decsaber 20, 1966

SPI FOOD PACKAGING MATERIALS COtftilTTSE
CONFEREHCR WITH FDA PKRSOHNEL 0M
FOOD ADDITIVE REGULATIONS
WASHINGTON, D.C., DECEMBER 13, 1966

1.

A special nesting of the SPI Food Packaging Materials
Conaittee was arranged with representatives of the
Food and Drug Attainistration to discuss present status
of Food Additive Regulations. FDA was represented by
Mr. Lessel L. Raasey, Deputy Director, Bureau of
Scientific Standards and Evaluation, and Sr. Joseph
McLoughlln, e scientist of long experience In the
Bureau. Industry questions were sent to Mr. Raasey
in advance of the aeeting and discussion was confined
to these questions or those vary closely related
because of limited tine.

2.

As sumary of the most import—t points in the attached
list of questions and answers three statements —y be
made. FDA concedes that much could be done to consolidate
and clarify present regulations but their personnel Is
inadequate, priority for this is low and they hope that
industry will offer leadership in this direction.
Present day regulations are not to be interpreted In
any broader sense then specifically stated, e.g., an
adjuvant or coating regulated for resin X may not be
used for resin T without petition —d regulation for
a—h OM. VS—Ily, toxicological end analytical data
—famltted to VttS are considered in the public do—in
after a regulation covering the additive has Issued.

3.

In the oplnl— of the writer, Mr. Re—ey and Dr.McLaughlin
gave as straightforward answers to questions as possible
under the circumstances. FDA 1s not likely to relinquish
any authority It thinks granted by the Act but would
welcome means and procedures to provide broader general­
izations in the regulations without sacrifice of public
safety.

W. A. Knapp
WAR:dak
V. A. Knapp
asi 00000137
Attachment
Consultant - Toxicol gy
cc: Mr. J. C. F doruk, Attn. Mr. C. B. Millar
Mr. J. L. Damon
Mr. K. W. Dteckmann,Circ.A.Steinberg, J.Kusonick,C.Thomson

Industrial Ch«l««li Division
Alii d Chemicals Cot »rati n

Answers to Question* «t FDA Conference of
S?I Fl*stic* packaging Sub-Committs«
December 13, 1966

(1)

With rsspoct to tbs ’no-migration’ concept in the Food
Additives Amendment, FDA tekes tbs position that if you
test for migration you ere conceding that the material
may rssaonsbly be expected to bee one e component of food
and is therefore a food additive. This attitude Is not
popular but rsnslns the official position of FDA. FDA
will still issue letters conceding that a notarial "nay
not reasonably be expected to bacons a conpoaent of food'
but the probability of migration oust be quite renote.
Mr. Ramsey cited the conclusion of the special conalttoe
of the National Research Council wherein it was stated
that registration of a pesticide on a no-residue basts
was scientifically untenable. By tbs sene reasoning,
the degree of aigration of a food additive should be
known and, if necessary, limits placed on migration.
FDA feels that unless a substance is GRAS there oast
be regulation controlling limit of addition and method
of determining additive. Whore use of edditivo is
self-limiting (e.g., food acids) limits are frequently
omitted. Catalysts In polymeric materials are mostly
not liatod in regulations because FDA has bean assured
by industry that residues are virtually non-existent
and do not migrate.

(2)

With respect to printing inks on packaging materials,
FDA takas attitude that they are not additives if there
Is s fumstlamal barrier between it and food. What con­
stitutes s ttastiooal barrier Is poorly defined and
r—Iws the Responsibility of the producer. In this
eeoaectiom, ftt* McLaughlin reminded that the polyolefins
sessslsmelly is permit migration end do not always
constitute s functional harrier. It may be presided
here as In first question that If you test for migration
and find soma you have a food additive. Dr. McLoughlin
also cited a case whore migration was detected via
off-taste in food.

AST 00000138

Questions and Aunti
SPI-FBA, 12/u/im

(3)

With respect to the Frawley hypothesis presented at tha
American Chemical Society Meeting in September 1966
("any component of an article contacting food which ia
present in the article or ita coating at a level not
exceeding 0.2% by weight la generally recognized aa aaf ,
provided it ia not a heavy natal or a pesticide"), FDA
has some objections. They point out that 0.2% of a
material in one coating may not be the equivalent of
the same amount of the material in another, l.e., there
may be no correlation between composition and migration.
Dr. McLoughlin conceded that it might be possible to
grant GRAS status to minor constituents under known
conditions of use, provided migration data are available.
From the total discussion to this point, the writer
gained the Impression that FDA wanted migration data
whether or not the migrant constituted any risk to
public health. They felt that they must In some manner
build up e total picture of additives in tha American
diet from all sources.

(4)

With respect to contenting FDA scientists, Mr. Ramsey
could see no objection to contacting before petition
was submitted or after review and latter from FDA outlining
any additional data needed. In ell eaaea he thought it
best to contact Mr. McFarland or one of hie administrative
staff and not tha scientist directly.
From his point
of view,any opinion from an individual scientist is not
the opinion of the FDA institution.

(5)

ORA$ —may usually be used aa a packaging or
prasesslag material component without further regulation,
but not always. FDA representatives reminded that GRAS
materials Us till. 101 are frequently Hated aa to use
er Mount used. Tha use of direct additives as compon­
ents of packaging materials la similarly subject to tha
same limitations. Concerning petitions for extension
of uses of a food additive by a company not supplying
toxicological data for original listing, FDA expounded
a new doctrine, namely, that toxicological date ia not
proprietary information and not confidential information
after a regulation has Issued, i.a., information is than
in tha public domain. To data, toxicological data has
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Quaetions and Asm:

SPI-m, 12/u/m*
usually been made Available to oav petitioners for ex­
tended uses of an old product bacauaa they ara usually
customers of tba producer and source of information is
positively located in FDA files. However, FDA will not
search their files for such information unless the FDA
scientist has recollection that information available
is adverse. We were told that this policy will extend
to analytical procedures and to manufacturing procedures
where such disclosure la naceaaary to insure safety
of the food. If the petitioner discloaes Information which
ha feels to be highly confidential, he should so identify
in the petition. If FDA feels that confidentlallty with
respect to such Information la not in the public internet,
they will notify petitioner who may reconsider disc lour .

(6) With respect to need for extraction studies, FDA wants
to know degree of migration of food addtive whether or
not the food additive has bees demonstseted to bo safe
at much higher levels. A second petitioner may request
regulation for another use of the some or very similar
additive and toxicologists want to know all sources of
the materiel, l.e., total body burden. It was also
mentioned that drugs and cosmetics may bo sources of
the sons materials added to foods. In short, FDA wants
migration date on every indirect additive sad believe
they have the pewar to demand it. Ultimately, this will
lead to reasonably accurate data on daily intake.
(7)

With respect to ratio of vdume of package to surface area
there is nothing magic about the 2-ml/in2 or 10-vl/in2
ratios. Seme recent regulations use the 2:1 ratio becaua
Of geometry ef the Msturt cell. Whet FDA wants to know
Is good estimate of total Intake of additive; If eonswaption Is ftam package of different ratio this may be
eeed. It IS settee*ly doubtful that change in calculated
intake vie aheage In retie will be judged adequate reason
for acceptance or rejection of e regulation.

(8)

If tbs miner ingredient is not included in par.(a) of
1121.2526 , extraction testa must bo run, l.e., regulati n
moans what it says. If one wishes to got the sdnor in­
gredient listed in par. (s) of this regulation they may
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Questions and Answers

SPWDA, 12/13/1966

submit petition Co justify. Dr. Mcloughlin pointed out
that May substances in par. (a) are limited as to purpose
and extent ef use.
(9) To Dr. McLaughlin e basic polymer is the product of poly­
merization of one or more monomers and may contain such
adjuvants as are necessary to the polymerization (l.e.,
catalyst, etc.). It does not include plasticizers and
other adjuvants added in formulation of the basic polymer
with other Mterials. It was suggested that industry
might wish to offer a definition of basic polymer.
(10)

A substance listed aa a permissible adjuvant in one
regulation My not be ueed in another regulation, i.e.,
e given regulation la not to be interpreted in any breeder
sense than la atated. FDA raalizaa, for axample, that
som coatings permittsd on one substrate My be equally
suitable on othara but thla la not always the ceee.

(11) In response to this question, FDA pointed out that they
prefer the functional type regulation end that they start d
this type on their own initiative. Industry, of course,
has petitioned for additions to these regulations but
they did not initiate the type. Such regulations would
probably require industry committees to assemble lists
of functional additives to be covered by the regulation.
(12)

There is e great deal that can be dona in the way of
codification of present regulations but FDA does not have
the personnel to do this immediately end there ere many
more pressing problaM. It was hinted that this is e
task industry night care to undertake. It wee stated
that Mm lnduttry knows more about polymers end packaging
than FDA daat tad that suggest loos from industry would
he unlearned. Shis looks like e good spot for an industry
eeamittee to make a thorough study end then offer e
complete re ■modification of Subpart F covering packaging
Mtarlale.

(13)

PDA will make no guarantees that conferences either prior
to or during consideration of e petition represent the
official institutional opinion. Thay are glad to give
advice during such conferences but one or two individuals
cannot make the total decision for FDA.

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QuaatLoos and Answers

Sfl-m* U/U/Mt

(14)

n* spoke—an think that some raaaonabla demonstration
of affleecy can be demanded. Legislative hiatory
indicates that Congress had in nind additlvaa with
sous uaaful purpose and that war* addition without
utility would not ha in tba public lntaraat.

(13)

Tha anawar la yaa - cartiflad food colora arc permitted
in food contact articles. With respect to inorganic
pigments (Cds, CdSe, Hgt compounds, etc.,) F&A la
concerned about any increase in present background
levels. The 10 ppb figure way not apply to highly
toxic netals.

(16)

Answered by (15) Above.

WAK
12/20/66

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