TELEPHONE HUDSON 3 6126

Manufacturing Chemists’ Association, Inc.
(FOUNDED 1872)

1825 Connecticut Avenue, N. W.

Washington, D. C. 20009
November 6,

TO:

Members of the Pood,
Chemicals Committee

SUBJECT r

Drug,

1967

and Cosmetic

Proposed Revised FDA Pood Additives
Procedural Regulations

Gentlemen:
I am enclosing a copy of the MCA statement
on this subject.
Sincerely yours.

Morgan M. Hoover
MMH:sjg
Enclosure

ASX

00002058

Tl I I PHONF Ml'PSON

Manufacturing Chemists' Association, Inc.
! FOUNDED

(.1 ()|(M

II

l.cm r.,1

!' S A

1872.

1825 Connecticut Avfnui. N. W.
Washington, D C 2f)00()

DI ( KI It
lt< t

fll V M ! I \ l

November 3,

1967

Miss Beryl Mccullar
Hearing Clerk
Department: of Health,
an^ Welfare

Kducation,

Room 5440
330 Independence Avenue,
Washington, D. C. 20201

3.W.

Reference:

Food and Drug Administration's
Proposed Food Additives
Procedural Regulations
(32 F.R. 11443)

Dear Miss MeCullar;
Pursuant to the proposed regulations,

we submit the

attached comments of the Manufacturing Chemists Association.
The Manufacturing Chemists Association is a nonprofit trade
association of i85 U.S. company members.
Collectively, the
membershin represents more than 90 percent of the basic
chemical manufacturing capacity in the United States.
Wc would like to take this opportunity to express what
we

feel are basic difficulties in the administration of

Section

-09 of the Food,

Drug and Cosmetic Act,

particularly

with relation to indirect additives.
Although the direct additives area of this section is
probab.lv of greatest concern to chemical producers,

we are

also intimately concerned with components of packaging
materials, both basic polymers and adjuvants, which mav

fall

within the purview of the Act if meaningful migration occurs.
In

this connection,

we

refer you to the presentations of

Dr. .Tohn P. Frawley before the September, 1966 meeting of the
American Chemical society and, more recently, before the
British Industrial Biological Research Association
the

(BIBRA),

latter published in the Food and Cosmetics Toxicology

Journal Jj, 293-308 (1967) .
In these Dr. Frawley concludes
that anv component of a food contact surface (the article
itself or

its coating)

present at a

level

of 0.2% or-

loss by

ASI 00002059

\ >

Miss Beryl McCullar
Page 2
November 3,

1967

weight will not contribute migrants of public health signif­
icance to the daily diet.
Heavy metals and pesticides are
excluded.

vie believe that Dr. Frawley's thesis provides a practical
solution to a very real problem, and urge that administrative
policy be established and regulatory provision be made for
rapid or automatic acceptance of food additives which are
present in packaging material in small quantity.
We urge also that the Commissioner evaluate our position
on the proposed regulations as put forth in the attached
comments,

that appropriate changes be made in any final

regulations that may issue, and that a public hearing be held
in connection with any final regulations.
Sincerely

G.

H. Decker

Attachment

ASI 00002060

MANUFACTURING CHEMISTS ASSOCIATION
COMMENTS ON FDA PROPOSED FOOD ADDITIVES
PROCEDURAL REGULATIONS (32 FR 11443)
8121.7

Food additives for use in feed and drinking water of
animals and food additives that are also new drugs,
certifiable antibiotic drugs and/or pesticides.

8121.7

(a)

(3)

We strongly urge that this Section be revised
to delete the word "chemical."
The limitation of
acceptable assay methods to "chemical assays" is an
unnecessary and illogical restriction as there may
be practical biological, physical, or other methods
which technically cannot be defined as chemical
assays.
To limit acceptable assay methods to chemical
assays would unduly restrict the constant search by
quality control personnel for better and more
practical methods of assay, some of which may be
better than chemical methods,
we point out that
neither Sections 505 nor 409 of the Federal Food,
Drug, and Cosmetic Act require that assay methods
relating to food additives be limited to chemical
assay methods.
8121.9

Food additive master files.

8121.9

(a)
We request that the words "submitting or in­
tending to submit a food additive petition" be
deleted from the first sentence of this Section,
in
many instances, the person submitting a food additive
master file is doing so for the benefit of another
company or person; he, himself, may not intend to
submit a food additive petition.
The last sentence of this same paragraph appears
to limit the use of these master files to use in food
additive petitions.
Many materials are used as adjuncts
in connection with foods, drugs, colors and pesticides,
in view of the voluminous nature of many of these master
files, it is believed that one master file should
suffice for all of these fields.

ASI 00002061

P.2

§121.9

(c)
We strongly urge that this subparaoraph La
deleted from the proposed regulation.

Master

files

are submitted voluntarily and represent a confi­
dential relationship between the Food and Drua
Administration and industry.
TWe believe that this
relationship should remain.
For our comments on
the confidentiality of analytical methods and
toxicological data in a

food additive petition,

please refer to §121.50

(f)

and particularlv to

the third full paragraph on p.
§121.50

Content and

§12.1,50

14.

form of food additive petitions.

(a)
It is requested that the third sentence of this
Section be amended to read as

follows:

Any published information used in
support of the petition shall be
submitted in reprint form, if
available, or other suitable photo­
copy,

and,

in the event that the

published material is readily avail­
able to FDA,

references can be made

to the publications

in

lieu of

furnishing reprints or photocopies.
Under the existing regulation 121.51 "reprints or
p'notostatic copies" of published information are
permissible,

we submit that the proposed regulations,

restricting the petitioner to reprints is not
practical and quite often will be impossible to meet.
In some instances,
number of reasons.

reprints are not available
We urge,

therefore,

for a

that either

reprints or other suitable photocopies be allowed to
support the food additive petition.
where the published material is

In addition,

from a journal or

other source readily available to FDA,
should be authorized to merely cite the
other source.

the petitioner
journal or

This procedure is presently being used

in the new drug and certifiable antibiotic areas
(§130.37)

and should also be adopted in connection

with food additive petitions.

ASr ^0002062

P. 3

It is also requested that the sixth scot race
which refers to unpublished scientific stu.~4.es be
amended to read as follows:
All original unpublished scientj_ Cic
studies supplied in the petition
shall include identification ana
a description of the qualifications
including educational background and
experience of the technical and
professional personnel who are
responsible for assuring the accuracy
and reliability of such studies.
This information need only be
furnished for the person or persons
who are the responsible head of the
laboratory or scientific unit con­
ducting the studies.
We point out that in many instances,
impractical to list the

it would be

identity and qualifications

of all the various technicians,

chemists,

toxicol­

ogists and other scientists or technical personnel
who participated in the unpublished study presented
in the petition.
We point out that in regard to
new drug applications §130.4 (c), subsection 2.8 (b)
requires that the detailed educational and background
information need only be given for the person re­
sponsible for assuring that the drug has the safety,
identity, strength, etc., which is claimed by the
application.
We submit that this information should
onlv be required for the person responsible for the
scientific studies presented in support of the
additive petition.
§121.50

food

(b)
Section 121.50

(b)

provides for the incorporation

by reference of previous submissions where the previous
submission ". . . is in a food additive master file
kept current by the petitioner, or is in another form
of submission not over 10 years old."

we do not understand the intent or meaning of
this 10 year limitation.
By implication, one could
i"onclude that, my data over 10 years old is deemed lo

ASI 00002063

P.4

be unreliable unless in a master file Kent current.
.'e suggest that many submissions whether nart of
mster fi.les (formerly designated ‘master riles"
~ow designated "food auditive master files ),

or

new drug applications, or data leasing to
or lot sanctions or approvals are of permanent value
reaardless of age.
For example, detailed"toxicologi"ui studies submitted in 1950 which lea to a prior
sanction or approval are still valid in many cases
■I’Otitions,

and data in food additive petitions filed since the
effective date of the Food Additives Amendment may
atiil be valid although over 10 years oin.
The net effect of such a 10-year limit on sub­
missions other than master file submissions js to
rocce petitioners to establish master files for inten­
tional or incidental food additive products.
vVe see
no justification for imposing this added buraen on a
petitioner whose formal petition filing should con­
stitute an adequate file record.
The oniv burden
petitioner should have in connection with the reference
to data already on file with FDA is a requirement of
an accurate description in sufficient detail to pro­
vide adequate identification thereof and a statement
reaffirming the current validity of any conclusions
therein.
For the above reasons, we would suggest deletion
of the 10-year limitation for submissions other than
those in a "master file kept current."
§121.50

(c)
This section prescribes paper size,
typing margins,

hole punchings,

etc.,

line spacing,

which must be

used in connection with petitions.
There are many
reasons which would make compliance difficult.
Some
are the following:
(1)
Except for legal purposes, the vast majority
of U.S. business establishments use only 8-5" x 11paper for correspondence,

report writing,

difficult to obtain any other size

etc.

except on special order at extra cost.

Carbon paper

of different size presents similar difficulties.

ASI 00002064

It is

from most stationers

-J

(2)

Photoreproduction papers are

3i!:rv:.re of

8H" x 11" dimension requiring tana triiranno Lo bring
to si2e prescribed.
(3)
It is often desirable for the sake of com­
pleteness to include past studies rather than incorporate
same by reference.
The proposed regulation would re­
quire retyping of thousands of pages of text and photoroduction of qraphs or pictures to brine to proper size,
(4)

4s noted in comments on §121.50

(n)

above,

reprints or photoreproductions of journal articles are
usually not of the prescribed size and would require
photoreduction or enlargement at needless and great
expense.
(5)

Similarly,

(toxicologists,

reports of outside investigators

consultants,

analysts,

etc.,)

are all

on paper of 8V x 11" dimension and would require
retyping or other reproduction to the size prescribed.
(6)

File cabinets,

file

folders,

record boxes,

ring binders, etc., are made to accommodate 8V x 11"
paper.
While 8" x 10*5" paper can be used in these
storage containers,
wasted.
(7)

10% of storage space therein is

To the best of our knowledge,

the vast

majority of prior submissions have been on 8V x
paper.

If §120.9

(b)

11"

means that master files must be

converted to 8" x 10*5" paper "as if it were a portion
of a petition"

the task would be an impossible burden.

For the reasons stated above and probably additional
complications not yet conceived, it is suggested that
paper size requirement be deleted.

Further,

it is

requested that double spacing be suggestive rather than
obligatory or the requirement modified by "where
practical."

The retyping of large amounts of available

material now in single space does not appear to be a
reasonable requisite
§121.50

(e)
We

for food additive petitions.

I.B.2.

request that this Section be amended to read as

follows:

ASI 00002065

I'.t»

USE.
The purpose which the additive
is to serve, including, if a direct
additive, an estimate of the avTnur*
quantity of the uirect foou additive
to be expected in the total uailv
diet of the consumer, and where possible
or practical, an estimate of the
maximum quantity to be expected in the
daily diet of the consumer.
The bases
for such estimates will be provided
in this summarv.
The introductory summary of use information required
in this Part B for both direct and indirect additives
is not practical as applied to indirect additives.
Incidental or indirect food additives, whether food
packaging or processing materials,

do not lend them­

selves to meaningful estimates of either the average
or the maximum levels that might be expected in the
total daily diet.
materials,

Food processing and packaging

unlike many direct

food additives,

generally

can be used for across-the-board food contact use,
thus coming into contact with countless types of foods
under a variety of industrial processing and packaging
use situations.

Indeed,

the petitioner for an indirect

food additive in most cases will have no way of knowing
all of the many packaging uses that the additive could
be used for.

We submit,

therefore,

that estimates of

either the average or maximum quantities that might
oecome part of the total daily diet will always be
relatively meaningless figures; as such, this information
should not be required for indirect adaitives.
We do not suggest the deletion of this requirement
for indirect additives without pointing out that FDA
has adopted and is presently following the philosophy
that the 100-fold safety factor (100 times the no-effect
level found in animals) adequately ensures the safety
of indirect food additives and can logically
be relied
upon to take care of multiple variables such as diverse
use and consumption.
The text "Appraisal of the Safetv
of Chemicals in Foods, Drugs, and Cosmetics,' published
by the Association of Food and Drug Officials of the
United States in

1959,

Thu. publication

relates the sensitivity of man to

/.iri'Hi:; spot ■ l
ratio is

; ol

that man

was written by FiV

animats and
is ton

reports

staff members.

Uial

I lie highest

times as sensitive as

the

or cat.
The safety factor of 100, then, provides
another multiple ten-fold difference to orotect. man
from possible adverse effects of a food, additive.

ASI 00002066

rat

P.7

The use of the factor cf 100 T.r. ni.?c endorsed
by the Joint FAO/WHO Export Commitieo on proo Additives.
In the Second Report of this Committee,

m the section

entitled "Procedures for the Testing of Intentional
Food Additives to Establish Their Safetv for Use"
(Sec vVHO Technical Reoort Series Jo. 144, porta 17,
1959), the Committee concluded"From these various investi«ar.ionr; a
dosage level can be estab]ished that
causes no demonstrable effect in the
animals used.

In the extrapolation

of this figure to man,

some margin

of safety is desirable to allow for
any species difference in susceotibility, the numerical differences
between the test animals and the human
population exposed to the hazard,

the

greater variety of complicating disease
processes in the human population, the
difficulty of estimating the human

*

intake and the possibility of synergistic
action among

food additives.

'It will be useful to try to define here
the standard daily dietary dose.

This

is taken to be the amount of the

food

additive that might be expected to be
consumed by an average adult eating a
normal diet as determined

from some

appropriate dietary survey.
It should
be assumed in these calculations that
all the foods likely to be treated with
the additive will contain it at the level
proposed.
"It is inescapable that some arbitrary
factor must be applied in order to provide
an adequate margin of safety.

Where the

maximum ineffective dc^ in animals is
calculated in g/kg body-weight, a margin
of safety of the order of 100 has been
widely used.
In the absence of anv
evidence to the contrary, the Committee
believes that this margin of safety is
adequate."

ASI 00002067

,

?.8

la addition to -che deletion of the

requirement

of an estimated quantity of daily consumption of an
indirect additive,

we urge that as

to direct additives,

a petitioner need only estimate the average quantity
of the direct food additive to be expect.'■ i in the
..otal umiy iiet of the consumer.
It should be
realized that an estimate of r.he average qunntLtv
will he a somewhat arbitrary figure,

but an estimate

of the maximum anticinated consumption will
;.es.

meaningful.

"actor of
direct

100 in

Again,

we point

out

i;e even

tvu the safety

judging the safety of the particular

food additive on the basis of animal toxicity

studies was designed to take care of the variations
in consumption by individual consumers.

For consistency with this entire
121.50,
we request that the phrase 'daily aiet
be used wherever
reference is made to the "diet of the consumer.1
In aad.ltLon, we request that the reference to
several species of test animals1' in the second
sentence oe amended to read

in test animals."

o”ncticai matter, normally only
animals are required by FDA.

as

>
a

two snecios of test-

rfith respect to the third sentence of this Jection,
we strongly urge that it be amended to read:
The margins of safety between the noeffect level in the most sensitive
species of test animals and,

with

respect to direct

food additives,

average

where practical to

level and,

determine,

the maximum level

the

likely

to occur in the total daily diet of
the consumer should be stated,

taking

into consideration previously approved
food additive uses

for the substance

and any toxicologically comparable
substance.
(Underlined l?nouace js new).
To support our request that the requirement for
estimating average and maximum quantifies of foou
aiditiven

to 'we consumed in n dailv diet he

t-o aircct additives we
dec lion

ASI 00002068

12L.d0

(e)

I.

limited

refer to our comments on
B.

2.

In addition,

we urge

P.9

that the consideration given

;o

c--*r.ip.-t

-;e

substances’ be limited co tnose bubsi:j>u-cs t.han
are known to be "toxicologies ,Iy comparn>jo.1
it
is well known that many substances arc comparable
Irom the standpoint of their '~ffect or use
but are not comparable

from a

safety o’

i.n food

i ox .-.ci Ig­

or chemical viewpoint.

§121.50

(c)

tl

(a) 0)

(b)

We

find this subsection confusing in that

several terms used therein appear to be descriptive
of the same thing,

namely,

for the food additive.
composition"

(b.i.),

the chemical specifications

Thus,

"complete quantitative

"food grade specifications"

(b.v.),

and "reproducibility" (b.vi), all, we believe, mean
substantially the same thing and would be best covered
by the term ’food additive specifications" or "food
grade specifications."
we submit that either of these
terms adequately describes "complete quantitative
composition" and "reproducibility" and request these
items be deleted.

§}21,50

(e)

h.

1. b.

‘

iv.

It is requested that this subsection in describing
food additives be amended to read:
iv.
Brief description of manufacturing
process(es) and a listing of raw materials
and their specifications.
We believe that a "brief description" of manufacturing
processes) should suffice for the purposes of evaluating
the safety of the

food additive petition by FDA.

Detailed

processing information would serve no real purpose.
We would point out that once a petition is approved and
a food additive regulation is published,

any manufacturer

may produce the additive using any manufacturing process
known, so long as the food additive meets the product
specifications established in the applicable regulation
and the manufacturer adheres to good manufacturing
practice.
The question arises as to whether petitioner
would be bound to the process described in his petition.
If so,

the developer of the new facet of food technology

would be placed at a severe disadvantage.

We believe

ASI 00002069

P.10

that the structure of §409 (b) of the Act, which
details the requirements for a petition, supports the
argument that production process information should
be required only in special situations and not as a
matter of routine.
In this regard, §409 (b) (2), subsections A
through E thereof, lists the basic statutory require­
ments of data that must be included in a petition.
No reference is made to production process information.
A separate subsection of §409 (b), namely, (b) (3),
deals with the problem of supplying, upon request of
the Secretary, "a full description of the methods used
in and the facilities and controls used for the pro­
duction of such additive."
Thus, we believe it was
the intent of Congress to provide that the Secretary
have the right to require such information where
relevant because of special circumstances, but not
merely as a matter of routine in every petition.
Otherwise, a separate section (b) (3) would be
meaningless since the requirement of production
process information would have been listed in subsection,
(b)(2) of §409.
Finally, we also urge that the proposed require­
ment in this subsection for detailing the analytical
,techniques used to check the raw material specifications
be deleted.
The important consideration is the final
product specification and validation of the analytical
methods used for the final product.
In special
situations, at the request of FDA, the description of
specific analytical techniques could be provided to
FDA but certainly they should not be required as a
routine matter.
§121.50

(e)

II. A.

1. b. v.

We request that the third sentence in this
section be revised to delete the word "production"
prior to the word "batches."
Very often, at the time
that the food additive petition is submitted no
production batches have been prepared.
Thus, it would
be impossible for a petitioner to submit data from
production batches.
Data from either laboratory
batches or controlled pilot plant batches should be
sufficient to show the range of impurities and by­
products to be expected and to show that the proposed
specifications can be met.

ASI 00002070

P.U

§121.50

(e) II. A. 2. a. vi.

Deletion of this requirement is suggested.
Methods presently available for determining molecular
weight distribution of polymeric substances are
generally complex and difficult to reproduce.
We
submit that extractive limitations for polymeric
materials in selected solvents adequately reflect
low molecular weight fractions which may be
suspect toxicologically and that molecular weight
distribution adds little to the appraisal of safety.
§121.50

(e)

II. A.

2. b.

iii.

Please refer to our comments on §120.50 (c) II.
A. 1. b. iv. with respect to requirements for manu­
facturing processes and analytical techniques used
to check raw material specifications.
With respect to the specific wording of this
paragraph, it is presumed that "adjuvants" referred
to therein refers only to such adjuvants as are in­
corporated in the basic polymer polymerization and
not to adjuvants in a resin formulation.
To our
knowledge, the final resin formulation has not been
the subject of a petition nor is it intended that
they should be.
Such formulations are comprised of
the basic resin to which may be added GRAS materials,
adjuvants listed under the basic resin regulation
and adjuvants otherwise permitted under Subpart F. as
in regulations of the types represented by §121.2511,
§121.2527 and §121.2541 as examples.
§121.50

(e)

II. A.

2. b.

iv.

As in §121.50 (e) II. A. 1. v..we submit that
production batches are normally not available at the
time of petitioning.
Hence the word "production"
should be deleted.
§121.50

(e)

II. A.

2. b. v.

As in comment on §120.50 (e) II. A. 1. b. above,
we submit that product specifications as given in
§121.50 (e) II. A. 2. b. iv. of the proposed regulation
are the proper measure of reproducibility.

ASI 00002071

P.12

$121.50

(e)

II. B.

For the reasons set forth in our comments under
Section 121.50 (e) I. B. 2., we ask that the second
sentence be amended to read:
The petitioner shall furnish, if a direct
additive, an estimate of the average quantity
of the direct food additive to be expected in
the total daily diet of the consumer, and
where possible or practical, an estimate of
the maximum quantity to be expected in the
daily diet.
§121.50

(e)

II. B.

1.

We strongly urge that the first sentence be
amended so that the data required need only be given
"if reasonably practical or possible to determine."
This qualification should apply to all the data sought
in this Section.
We point out that the use information
and specifications provided in the petition are designed
to ensure the expected tolerable and safe level of the
additive.
The analytical methods are designed to
measure the levels of the additive in a particular
food or class of foods.
The requirement in this
.proposed Section for showing the fate of the additive
in food, conversion information, and possible reaction
with other components of the food, is not necessary
and very often, cannot be readily determined.
As a
practical matter, where final assays do not show an
acceptable level of the direct additive, a petition
is not likely to be approved by FDA.
§121.50

(e)

II. B.

2.

Although migration data using actual and simulated
foods will determine extent of transfer of a food
additive in terms of milligrams per square inch of
food contact surface under conditions of use, we
submit that it will not provide information from which
the average or maximum daily dietary intake can be
calculated for reasons stated in S121.50 (e) I. B. 2.
above.
Accordingly, comments there are equally
applicable to this subsection.

ASX 00002072

P.13

§121.50

(e)

II. D.

2.

This subsection requires that in the case of
the food additive needing a tolerance the regulatory
method (analytical procedure) ". . .be satisfactory
for application to the raw, processed, and/or finished
food."
This requirement is presumably intended for
direct additives or those substances incidentally
present in a final food product because of addition
for functional use elsewhere in the production
operation.
T.Ve trust that this subsection is not
intended to cover indirect additives as represented
by extractives migrating from packaging materials.
These extractives are multicomponent in character
and in many cases it would be extremely difficult
if not impossible to determine accurately amounts of
individual components in food per se.
Accordingly,
it is suggested that this requirement be 3imited to
direct additives and incidental additives (those
substances incidentally present in a final food
product because of addition for functional use else­
where in the food production operation).
§121.50

(f)
For the reasons set forth below we request that
this Section be amended to read:
Data in a petition regarding any method or
process entitled to protection as a trade
secret will be held confidential and will not
be revealed unless it is necessary to do so
in a regulation, and the petitioner approves
of such regulation or in the alternative
chooses to withdraw his petition, or in an
administration hearing preliminary to any
judicial proceedings under the Act.
The
analytical methods which do not reveal con­
fidential processing information and the
general summary of the toxicological basis
on which a food additive regulation is based,
as such general summary was presented and so
designated in the petition, are not considered
confidential or entitled to protection as trade
secrets.
Detailed descriptions of toxicological
studies and the raw data of such studies will be
considered confidential and entitled to protection
from general disclosure.
(Underlined language is
new.)

ASI 00002073

P.14

It

is our unified belief that in-process analytical

methods and toxicological data should be entitled to
protection as are trade secrets and remain confidential.
The development of toxicological data and analytical
methods are two of the most costly aspects of food
additive petitions.
Toxicological data is not
necessary for enforcement purposes and sFiould not
under any circumstances be released as public infor­
mation, unless the petitioner consents to such release.
If it is deemed necessary to publish information
concerning analytical methods in a regulation, the
petitioner should be given the opportunity,
publication,

prior to

to decide whether he wishes to have such

information published or wishes to withdraw his petition.
We take particular note of the
301

(j)

makes

of the Federal Food,

it an offense

Drug,

fact that section
and Cosmetic Act

for any person to use to his own

advantage or reveal to other than the secretary or
officers or employees of the department or to courts
under certain circumstances any information acquired
under Sections 404, 409, 505, 506, 507, 704 or 706
concerning any method or process which as a trade
secret is entitled to protection.

We believe that

the arbitrary designation of analytical methods and
toxicology as non-confidential is beyond the scope
of FDA statutory

authority.

We must strongly request that Section 121.9 (c)
be deleted, since the development of methodology may
be a major expense involved in the development of a
marketable food additive and in addition, we see no
reason that the toxicological information in support
of a food additive petition, also developed at a
major expense to the petitioner, be released for
public disclosure.
If this request is not honored,
we would ask that this Section be amended in
accordance with the language set forth above.
§121.51

Frocessing of food additive petitions.

§121.51

(b)
It is suggested that this subsection be

revised

so as to delete the words "or as appropriate.'

ASI 00002074

P.15

Section 409 (b) (5) of the Food, Drug and
Cosmetic Act clearly states that 'notice of the
regulation proposed by the petitioner shall bo
published in general terms by the secretary within
thirty days after filing."
Congress has clearly
not required the agency to specify in detail in a
food additive proposal the specific claims made for
the food additive.
In the past, the agency has
noticed human food additive proposals in the Federal
Register on a broad general basis in accordance with
the statutory authority.
On the other hand, with
respect to animal food additive petitions, the agency
has set forth the proposal in great detail.
it is
suggested that human food additive proposals and
animal food additive proposals should be treated
equally, and both should be published in the Federal
Register in general terms.
Publication of the details of a proposal (prior
to approval) is an invitation for purchasers to use
the food additive (particularly in animal feeds) for
a use which has been proposed but not yet the subject
of a regulation.
The publishing of the proposal in
general terms without reference to specific claims,
would eliminate this possibility.
§121.51

(c)

If further information or sample is requested
by FDA "a reasonable time in advance of 180 days,
but is not submitted within such 180 days after filing
the petition, the petition will be considered with­
drawn without prejudice."
It is suggested that
"reasonable time in advance of 180 days" is too in­
definite and that "180 days" implies that if added
data are required the petitioner has no hope for a
regulation within the 90 days provided by Section
409 (c) (2) of the Food, Drug and Cosmetic Act and
little hope of obtaining a regulation within the
statutory limit of 180 days.
While we would hope that
request for sample and/or additional data be made
within 45 days after date of filing, a limit of 90
days would appear equitable.
It must be recognized
that the time required to provide information or
sample may vary from days to months depending upon
nature of the request.
The petitioner should not be
penalized by withdrawal of petition when, in fact,
notice in advance of 180 days is not adequate to fill
request.

ASI 00002075

?. 16

§121.51

(d)
It is respectfully requested that petitioner
bo provided an opportunity to review language of a
proposed regulation prior to publication in the
Federal Register if it differs from that proposed
bv petitioner (§121.50 (e)II.F.) and that this sub­
section be so revised.

Submitted November

ASI 00002076

3,

1967