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FROM

John H. LeJinert

ASI 00001647

DRAFT

Hearing Clerk
Department of Health, Education and
Welfare
Room 540
330 Independence Avenue, S.W.

Washington, D. C. 20201
Dear Sir:
Pursuant to the proposed Procedural Regulations covering
organization and handling of Food Additive petitions as
published in the Federal Register of August 8, 1967, page
11443 et seq., we respectfully submit herewith comments of
the Manufacturing Chemists' Association prepared with the
assistance of its Food, Drug and Cosmetic Chemicals Committee.
Before proceeding with question and comment on wording
and intent of the proposed regulation we would like to take
this opportunity to express what we feel are basic difficulties
in the administration of Section 409 of the Food, Drug and
Cosmetic Act, particularly with relation to indirect additives.
Although the direct additives area of this section are
probably of greatest concern to manufacturing chemists, we
are also intimately concerned with components of packaging
materials, both basic polymers and adjuvants, which may fall
within the purview of the Act if meaningful migration occurs.

ASI 00001648

Draft Page 2,

Much uncertainty arises in the determination of what
constitutes meaningful migration.

Administration policy

notwithstanding, we maintain that the act of testing for
migration is not in itself evidence that the additive may
reasonably be expected to migrate.

Modern analytical

techniques will detect minute quantities of materials which
may or may not be identifiable as coming from a packaging
material but which may reasonably be expected to be toxicologically insignificant.

We do not believe that it was the

intent of Congress to control these very small amounts of
relatively non-toxic migrants which usually can be detected
from most packaging materials.
The plastic package of today and the adjuvants therein
do produce migrants but at quite low levels and from which
no deleterious effect has yet been demonstrated.

We submit

that the vast majority of adjuvants added in small quantity
to packaging materials do not migrate in quantities which
are toxicologically significant and should be exempt from
exhaustive safety evaluation prior to marketing.

In this

connection, we refer you to the presentation of Dr. John P.
Frawley before the September, 1966 meeting of the American

ASI 00001649

Draft Page 3

Chemical Society.
M .

.

In this he reaches the conclusion that

. any component of an article contacting food which

is present in the article or its coating at a level not
exceeding 0.27» by weight is generally recognized as safe
provided it is not a heavy metal or pesticide."

We submit

that a practical solution might be to establish a realistic
level for the components of a packaging material below which
there need be no concern with migration, provided, of course,
that the materials are known not to be highly toxic.
The purpose of this discussion is to urge that administ­
rative policy be established and regulatory provision made
for rapid acceptance of food additives which are present in
packaging material in small quantity (e.g., <0.27o), or which
would not be expected to be found in significant quantities
(e.g., 0.1 ppm) in the daily diet.
The comments submitted herewith represent, in substance,
comments submitted to the Manufacturing Chemists' Association
by many of its member companies.

It is expected that many

of these companies will also submit their comments directly
to the Food and Drug Administration.

We respectfully urge

the Commissioner to carefully evaluate our position on the
proposed regulations and ask that appropriate changes be
made in any final regulations that may issue.

We strongly

ASI 00001650

Draft Page 4.

urge that, in finalizing any regulations in this area and
in evaluating the existing food additive regulations,
especially those dealing with indirect food additives,
that careful consideration be given to the substantive
problems we have discussed regarding the administrative
treatment and handling of these materials.

ASI

00001651

■S'W Ocr» •*-/

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ASI 00001652

MANUFACTURING CHEMISTS' ASSOCIATION
COMMENTS ON FDA PROPOSED FOOD ADDITIVES
PROCEDURAL REGULATIONS (32 FR 11443)
§121.7

p .
' '

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

§121.7 (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.

§121.9

Food additive master files.

121.9 (a)
We request that the words "submitting or intending
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.

ASI 00001653

P.2.

In view of Che voluminous nature of many of these master
files, it is believed that one master file should suffice
for all of these fields.

§121.9 (c)
We strongly urge that this subparagraph be deleted
from the proposed regulation.

Master files are submitted

voluntarily and represent a confidential relationship
between the Food and Drug Administration and industry.
We believe that this relationship should remain, except
wherein parts of the master file are incorporated in
petitions by reference.

For our comments on the confid­

entiality of analytical methods and toxicological data
in a food additive petition, please refer to §121.50 (f).

§121.50

Content and form of food additive petitions.

§121.50 (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 photocopy, 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
photostatic copiesrr 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, reprints are not available for a number of
reasons.

We urge, therefore, that either reprints or

ASI 00001654

P.3.

other suitable photocopies be allowed to support the
food additive petition.

In addition, where the pub­

lished material is from a journal or other source
readily available to FDA, the petitioner should be
authorized to merely cite the journal or other source.
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. .
It is also requested that the sixth sentence which
refers to unpublished scientific studies be amended to
read as follows:
All original unpublished scientific
studies supplied in the petition shall
include identification and a descript­
ion 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 conducting the studies.
We point out that in many instances, it would be imprac­
tical to list the identity and qualifications of all the
various chemists, toxicologists 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
responsible for assuring that the drug has the safety,

ASI 00001655

P.4.

identity, strength, etc., which is claimed by the
application.

We submit that this information should

only be required for the person responsible for the
scientific studies presented in support of the food
additive petition.
§121.50 (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.n
We do not understand the intent or meaning of this
10 year limitation.

By implication, one could conclude

that any data over 10 years old is deemed to be unreliable
unless in a master file kept current.

We suggest that

many submissions whether part of master files (formerly
designated "master files" or now designated "food
additive master files"), petitions, new drug applications,
or data leading to prior sanctions or approvals are of
permanent value regardless of age.

For example, detailed

toxicological studies submitted in 1950 which led to a
prior sanction or approval are still valid in many cases
and data in food additive petitions filed since the
effective date of the Food Additives Amendment may still
be valid although over 10 years old.
The net effect of such a 10-year limit on submissions
other than master file submissions is to force petitioners
to establish master files for intentional or incidental
food additive products.

We see no justification for

imposing this added burden on a petitioner whose formal
petition filing should constitute an adequate file record.

ASI 00001656

P.5.

The only 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 provide adequate identification thereof and a
statement reaffirming the current validity of any con­
clusions 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, line spacing,
typing margins, hole punchings, etc., 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 8-1/2" x 11"
paper for correspondence, report writing, etc.

It is

difficult to obtain any other size from most stationers
except on special order at extra cost.

Carbon paper

of different size presents similar difficulties.
(2)

Photoreproduction papers are likewise of

8-1/2" x 11" dimension requiring hand trimming to bring
to size 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 require

retyping of thousands of pages of text and photoreduction
of graphs or pictures to bring to proper size.

ASX 00001657

P.6.

(4)

As noted in comments on §121.50 (a) 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, reports of outside investigators

(toxicologists, consultants, analysts, etc.,) are all
on paper of 8-1/2" 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 8-1/2 x 11"
paper.

While 8" x 10-1/2" paper can be used in these

storage containers, 10% of storage spece therein is
wasted.
(7)

To the best of our knowledge, the vast majority

of prior submissions have been on 8-1/2" x 11" paper.
If §120.9 (b) means that master files must be converted
to 8" x 10-1/2" paper "as if it were a portion of a
petition1* 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 for food additive petitions.

ASI 00001658

P.7

§121.50 (e) I.B.2.
We request that this Section be amended to read as follows:
USE. The purpose which the additive is
to serve, including, 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 of the consumer.
The bases for such estimates will be
provided in this summary.
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 themselves to mean­
ingful estimates of either the average or the maximum
levels that might be expected in the total daily diet.
Food processing and packaging materials, unlike many
direct food additives, generally can be used for acrossthe-board food contact use, thus coming into contact
with countless types of foods under a variety of indus­
trial 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 become part of the total
daily diet will always be relatively meaningless figures;
as such, this information should not be required for
indirect additives.

ASI 00001659

P.8.

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 Safety of Chemicals in Foods, Drugs, and Cosmetics,"
published by the Association of Food and Drug Officials
of the United States in 1959, was written by FDA
staff members.

This publication relates the sensitivity

of man to various species of animals and reports that
the highest ratio is that man is ten times as sensitive
as the rat or cat.

The safety factor of 100, then,

provides another multiple ten-fold difference to protect
man from possible adverse effects of a food additive.
The use of the factor of 100 was also endorsed by
the Joint FAO/WHO Expert Committee on Food Additives.
In the Second Report of this Committee, in the section
entitled "Procedures for the Testing of Intentional
Food Additives to Establish Their Safety for Use"
(See WHO Technical Report Series No. 144, page 17,1958),
the Committee concluded:
"From these various investigations a
dosage level can be established 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 suscept­
ibility, the numerical differences

ASI 00001660

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.
rlt 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 dose 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 any
evidence to the contrary, the Committee
believes that this margin of safety is
adequate."
In addition to the 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 expected in the total daily diet of
the consumer.

It should be realized that an estimate of

the average quantity will be a somewhat arbitrary figure,
but an estimate of the maximum anticipated consumption
will be even less meaningful.

Again, we point out that

the safety factor of 100 in judging the safety of the

ASI 00001661

P.10.

particular direct food additive on the basis of animal
toxicity studies was designed to take care of the
variations in consumption by individual consumers.

§121.50 (e) I. B. 5.
For consistency with this entire Section 121.50, we
request that the phrase "daily diet" be used wherever
reference is made to the "diet of the consumer,"
In addition, we request that the reference to
"several species of test animals" in the second sentence
be amended to read "in test animals,"

As a practical

matter, normally only two species of test animals are
required by FDA.
With respect to the third sentence of this Section,
we strongly urge that it be amended to read:
The margins of safety between the no-effect
level in the most sensitive species of test
animals and, with respect to direct food
additives, the average level as well as the
maximum level, where practical to determine,
likely to occur in the total daily diet of
the consumer should be stated, taking into
consideration previously approved food addi­
tive uses for the substance and any toxicologically comparable substance.
(Underlined
language is new).
To support our request that the requirement for estimating
average and maximum quantities of food additives to be
consumed in a daily diet be limited to direct additives
we refer to our comments on Section 121.50 (e) I. B. 2.
In addition, we urge that the consideration given to
"comparable substances" be limited to those substances
that are known to be "toxicologically comparable."

ASI 00001662

p.ll.

It is well known that many substances are comparable from
the standpoint of their effect or use in food but are not
comparable from a safety or toxicity or chemical viewpoint.

§121.50 (e) II (A) (1) (b)
We find this subsection confusing in that several
terms used therein appear to be descriptive of the same
thing, namely, the chemical specifications for the food
additive.

Thus, "complete quantitative composition" (b.i.),

"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.

§121.50 (e) II. A. 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
process(es) 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

ASl 00001663

P.12.

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

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 requirements 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 production 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 require­
ment of production process information would have been
listed in subsection (b)(2) of §409.
Finally, we also urge that the proposed requirement
in this subsection for detailing the analytical techniques
used to check the raw material specifications be deleted.

ASI 00001664

P.13.

The important consideration is the final product specific­
ation 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.

8121.50 (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 pro­
posed specifications can be met.

§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.

ASX

00001665

P.14
§121.50 (e) II. A. 2. b. iii.
Please refer to our comments on §120.50 (e) II. A. b. iv.
with respect to requirements for manufacturing processes
and analytical techniques used to check raw material
specifications.
With respect to the specific wording of this para­
graph, it is presumed that "adjuvants" referred to
therein refers only to such adjuvants as are incorporated
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 8121.50 (e) II. A. 1. v. we submit that prod­
uction 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 specificationsas given in
§121.50 (e) II. A. 2. b. iv. of the proposed regulation
are the proper measure of reproducibility.

1

ASI 00001666

P.15

§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.

ASI 00001667

P.16

§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 §121.50 (e) I. B. 2. above.
Accordingly, comments there are equally applicable to
this subsection.

§121.50 (e) IX. 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.

We trust that

this subsection is not intended to cover indirect addi­
tives 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.

Accord­

ingly, it is suggested that this requirement be limited
to direct additives and incidental additives

(those

substances incidentally present in a final food product
because of addition for functional use elsewhere in the
food production operation).

ASI 00001668

P.17

§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 toxico­
logical studies and the raw data of such
studies will be considered confidential and
entitled to protection from general disclo­
sure.
(Underlined language is new.)
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.

While knowledge of (final product)

analytical techniques may be necessary for enforcement
purposes by FDA, and as such, ultimately disclosed in
an enforcement action, no real need is seen for author­
izing general public disclosure of such knowledge.
Toxicological data, and even a summary thereof, is not
necessary for enforcement purposes and should not under
any circumstances be released as public information,
unless the petitioner consents to such release

ASI 00001669

P.18

Arguments that disclosure of methodology and
toxicological information are necessary to permit non-FDA
experts to evaluate such methods and toxicological data
are rebuttable as there are other means available to
the FDA for substantiating this information as it appears
in the food additive petition.
If it is deemed necessary to publish information
concerning analytical methods in a regulation, the
petitioner should be given the opportunity, prior to
publication, to decide whether he wishes to have such
information published or wishes to withdraw his petition.
We take particular note of the fact that Section
301 (j) of the Federal Food, Drug, and Cosmetic Act
makes it an offense for any person to use to his own
advantage or reveal to other than the secretary of
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 in fact an attempt to usurp the
function of the courts and goes beyond the authority
granted to FDA by the legislature.
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.
ASI 00001670

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•

P.19.

§121.51

Processing of food additive petitions.

§121.51 (b)
It is suggested that this subsection be revised so
as to delete the words "or as appropriate."
Section 409 (b) (5) of the Food, Drug and Cosmetic
Act clearly states that "notice of the regulation
proposed by the petitioner shall be 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 accord­
ance 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 approved.

The

publishing of the proposal in general terms without
reference to specific claims, would eliminate this
possibility.

A$I

OOOOl-671

P.20.

121.51 (c)
If further information or sample is requested by
FDA na reasonable time in advance of 180 days, but is
not submitted within such 180 days after filing the
petition, the petition will be considered withdrawn
without prejudice."

It is suggested that "reasonable

time in advance of 180 days" is too indefinite 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.

1121.51 (d)
It is respectfully requested that petitioner be
provided an opportunity to review language of a proposed
regulation prior to publication in the Federal Register
if it differs from that proposed by petitioner (§121.50(e)II.F.)
and that this subsection be so revised.

ASX °°001672