LAW OFFICES
Keu.ee
JOSEPH E, KELLER

and

Heckman

1130 17™ STREET, S. W.

JEHOME H

HECKMAN

CHARLES M

MEEHAN

SUITE lOOO

WILLIAM IX. QOftOHESANI, JR,

WASHINGTON, T>. C.

TELEPHONE

20036

BLACK

DAVID L

HILL

MAHTIN W
MARC K

296-2100

CABLE ADDRESS

ROBERT li.TIKHNAN
WAYNE V,

5302

May

BERCOV1CI

16,

KELMAN

1972

SHAYE

LELAND tJ BLAIR
PETER M

NEMEOV

Mr. Robert M. Miller
Hercules, Inc.
Delaware Trust Building
Wilmington, Delaware 19898
Re:

Food and Drug Administration's
Proposed Rulemaking; Procedures
for Affirmation of GRAS Status
and Determination of Food Additive
Status (37 Fed. Reg. 6207).

Dear Bob:
With sincere apologies for the short time
I am allowing you and the others receiving copies of
this letter to review the material, I am herewith en­
closing a draft of the Comments we would propose to
file on behalf of The Society of the Plastics Industry
in connection with the referenced Rulemaking.
As you know, we have for some time felt
that the FDA Proposal should be employed to at least
raise a number of questions about the present handling
of incidental food additives problems and, where
possible, to make suggestions for changes.
Our think­
ing in this respect is simply that, obviously, we must
continue to raise these questions with FDA whenever an
opportunity presents itself in the hope that someday,
somehow, we will be able to obtain "high priority"
consideration of our "low priority" food additives
problem.
We suspect that you will find the enclosed
pleading a little unusual, and hope that perhaps FDA
will ultimately feel the same way.
Our objective, of
course, is to try to bring about a restructuring of
the incidental additives regulatory scheme so that some

MAY 1 8 1972

ASI-PR 0001466

Mr. Robert M.
May 16, 1972
Page Two

Miller

version of the old "Ramsey proposal" can be adopted
to delimit the necessity for filing full-scale Food
Additive Petitions on substances of obvious toxicolo­
gical insignificance.
Bearing in mind that the Comment deadline
date in the proceeding is May 26, and again with sincere
apologies for the short notice, I am hereby asking that
anyone who feels that the enclosed draft is inappropriate,
or should be revised in any way, let my office know by
telephone as promptly as possible.
I will be here from
May 22 through May 24 so sometime during this period
would be the best tiitu. to give me your thoughts.
We
can then place the statement in final order and submit
it on
May 26.
I will be looking forward to hearing from
any of you with suggestions to offer.

Enclosure
cc:

SPI Food, Drug and Cosmetic
Packaging Materials Committee

ASI-PR 0001467

[Please note:
This May 16, 1972 draft is considered by us to
be a working document only.
The final comments will, we hope,
properly reflect corrections, additions, and revisions oc­
casioned by FDCPMC members' reactions]

Hearing Clerk
Department of Health, Education,
and Welfare
Room 6-88
5600 Fishers Lane
Rockville, Maryland
20852
Re:

Food and Drug Administration's
Proposed Rulemaking; Procedures
for Affirmation of GRAS Status
and Determination of Food
Additive Status (37 Fed. Reg. 6207)

Dear Sir:
Pursuant to
Act,

as

amended,

Section

5 U.S.C.

4

of the Administrative Procedure

§553 (c),

and the referenced Food

and Drug Administration Notice of Proposed Rulemaking pub­
lished on March 18,

1972,

(SPI),

by

The Society of

Industry,

Inc.

its

its Food,

Drug and Cosmetic

attorneys,

the Plastics
and acting through

1/
Packaging Materials

Committee,

1/ The Society of the Plastics Industry, Inc. (SPI) is a
Corporation organized under the Membership Corporation Law of
the State of New York.
It is composed of approximately 1200
member companies and individuals who supply raw materials;
process or manufacture plastics or plastics products; engineer
or construct molds or similar accessory equipment for the
plastics industry, and engage in the manufacture of machinery
used to make plastics products or materials of all types.
SPI
is the major national trade association of the plastics in­
dustry, its membership being responsible for an estimated 75%
of the total dollar volume of sales of plastics in this country.
The Food and Drug Administration is quite familiar with the
constitution and activities of the Society as a result of our
many filings and participation in other proceedings of direct
consequence to plastics producers.
Copies of SPI membership
directories, organization charts, and the like have been sup­
plied to FDA in connection with some of these filings.
Any
further background information desired can bo supplied (con't)

0001468

ASl"pR

2

hereby

respectfully submits

its

referenced proposed amendments

views with

regard to the

above-

to Part 121 of the Food and

Drug Administration's Regulations.

I
INTRODUCTION AND GENERAL STATEMENT OF
POSITION; REQUEST FOR ORAL ARGUMENT
By means

of the

rulemaking proposal which

is

the

subject

of these Comments,

the Food and Drug Administration appears

be

a new approach to the handling of

looking towards

of the

general

food additives

a segment

regulatory problem which might

well

add a degree of rationality to what has been largely a

maze

of

confusion

and uncertainty since

extent that this is

the

case,

primary interest here is
contact surface"

area,

indirect additive,

the proposal
as

to the

doubt as

same time,

"food

however, we are dismayed to note that

for parts

to how it will serve

dustry and the public with
food additive

or

chaos.

raises many questions;

legal basis

To the

commend the Administration for making

some effort to bring order out of
At the

at least 1960.

and bearing in mind that our

in the

we

to

so many that we have doubt

of the proposal,

the

and even more

useful purpose of providing in­

a better understanding of the

indirect

"ground rules."

Among other things,

there is

nothing in the explanatory

statement or the proposal to indicate
FDA's mention in several places
1/ (con't.) immediately
Administration.

of its

the

statutory basis

intent

for

to evaluate and

upon request by the Food and Drug

ASI-rr 0001469

3

pass on the

"functionality"

"functionality"
text,

is

of indirect additives.

equatable to

"efficacy"

we respectfully submit that Congress

If

the

in the present con­
specifically re­

jected giving FDA authority

to pass on efficacy except in

very unusual

i.e.

circumstances,

whe

a a

term

tolerance must be

2/
established to protect the public health,
circumstances have never come into play,
knowledge,

where indirect additives

and that
to

the best of our

are concerned.

Other points which we consider confusing,
significant because
plified by the

they

these

or especially

are not discussed at all are

following listing

exem­

(discussed in more detail

hereinafter):
1.

How will

the proposed new procedures/

which will necessarily bring about the

filing

of still more

be

food additive petitions,

administered as
has

thus

far

a practical matter when FDA

found it virtually impossible

to act on any but a very
(an estimated

50

to

70%

indirect food additives)

few regular petitions
of which relate to
within the

180 day

2/^c'f. Section 409 (c) (3) (A) and 409 (c) (4) of the Federal Food,
Drug, and Cosmetic Act, as amended.
A review of these provisions
demonstrates that FDA, in dealing with food additives, must be
convinced of their safety, but may only deal with the question
of efficacy where a true "tolerance" is necessary to assure
safety.
The entire legislative history of the 1958 law confirms
this view.

ASI-PR 0001470

4

statutory deadline provided
of regulations
Section

2.

409

Is

list as

or amendments

for promulgation
responsive

to

Petitions?

it intended that FDA will treat,

"generally recognized as

packaging materials or other

safe"

and

(GRAS),

food contact

surface components when appropriate
satisfy a seller or user that the

tests

substance

involved may not reasonably be expected to
become a component of
not a

foods,

and,

hence,

is

food additive under the basic Statute

(Section

201 (s))

or FDA's

(Section 121.1(e)).

Regulations

This may seem to be

a question which answers

itself,but fourteen

years of very difficult experience

indicates

the contrary to be

is

the case.

marily because FDA's

status

of situations,

pri­

scientists have refused

to concur in non-migrant,
additive,

This

ergo non-food

in all but a very

few types

and despite supporting data

acquired under grossly exaggerated test con­
ditions.

Such refusals have occurred somewhat

erratically but often even when scientists
equal competence to FDA's,

of

and with even more

ASI-PR 0001471

5

experience as
components,

to specific packaging materials

have concluded that there is

reasonable expectation of migration to

3.

Will the proposal require

or GRAS petitions
test data is
Foods

to be

food additive

interpreted by the Bureau of

of migration to

area has been

most prolonged and,

"insignificant

foods

or food contact surfaces?
vexatious

foods.

filed in cases where

to indicate possible

levels"

no

from packages

Indeed,

this

the subject of the

thus

far,

fruitless

debate between FDA and the packaging in­
dustries.

If

this rulemaking proceeding is

intended to at least help deal with it forth­
rightly,

and bring reason into play in the

field of scientific

judgment,

seem to purport to do,
much clearer

4.

this

it would

should be made

than is now the case.

Where a GRAS petition is

appropriate or proper to open
petition to public view if,
things,

as

FDA will

require,

filed,

If

this

it

the entire

among other

under Section 121.40(c) (1) ,

that all details of past usage be
Petition?

is

is done,

included in

the

many petitioners may

ASI-PR 0001472

6

well

have

to

lay open customer lists,

important trade secrets
Section
Act,

302 (j)

now protected under

of the Food,

and the Public

and other

Drug and Cosmetic

Information seciion of

the Administrative Procedure Act
of Information Act").

This

("Freedom

type of information

would even be protected under the Agency's
new proposal

to release a great deal of other

information now held confidential.
37 Fed.

Reg.

No.

88,

pps.

9128

and

(See
9129

and esp­

ecially the discussion of the trade secrets,
etc.

exemption plan.)

sistency alone,
be revised to

the

For the

sake of con­

instant proposal

should

assure protection of such in­

formation.

5.
rules

In what specific ways will the new
do anything to expedite clearances or

rejections of GRAS or other substances,
help clarify product classifications
the packaging industries,

6.

Will

there be

food additive regulations,
are

instituted on

for

or their customers?

time limits

action on GRAS petitions,

and

for

final FDA

or proposed interim
whether the

same

the Commissioner's own

ASI-Pp 0001473

7

initiative,

or at

the

instance of outside

parties ?
At least as we view the situation,
these questions,

failure to

consider

and explain how they will be handled,

casts

serious doubt on the value of the rulemaking proposal.
as

in all other

instances

limiting our observations

in these Comments we are,
to

Here,

of course,

indirect food additive problems.

3/
It
that

(1)

factual
(2)

is our position,

indirect
situations

just as

it has

and questions

though

there are means

than direct

far less demanding,

pense,

requires

special
and

(3)

available to deal with the problem on bases

fully known to FDA and the public)

"folderol,"

food additives;

treatment;

which would allow most indirect additives
made

1956*

food additives present entirely different

sensible handling of these situations

and discrete,

been since

waste of scarce scientific

and processing delays

what the Administration's

to be cleared

without
talent,

(yet

the procedural
time,

and ex­

now involved with respect to

staff has

always declared to be

its

lowest priority concern vis-a-vis public health.

3/ Statement of John G. Kuniholm on Behalf of The Society of
the Plastics Industry, Inc.; Hearings Before a Subcommittee of
the Committee on Interstate and Foreign Commerce, House of
Representatives, Eighty-Fifth Congress, On Bills to Amend the
Federal Food, Drug and Cosmetic Act With Respect to Chemical
Additives in Food, (Pages 145-152).

ASI-PR 0001474

8

Rather than burden this
tion of information
tion's
as

hands,

already in

set of Comments with a repeti­
the Food and Drug Administra­

albeit apparently bypassed heretofore as

definitive action is

concerned,

far

we respectfully request that

the agency consider incorporated bv reference herein the

1/
following documents:
1.

The lengthy Comments

of The

Society of

on November

6,

filed on behalf

the Plastics

1967

Industry,

in response

to the FDA

Notice of Proposed Rulemaking of August
1967

(32 Fed.

Reg.

No.

which

looked towards

152,

p.

Inc.

11443

8,

et_.

seg.)

amendment of the Food

Additives procedural regulation:;.

2.

The Transcript of the National Con­

ference on Indirect Food Additives held on
February 13,

14,

1968.

It would

also be

helpful if the Food and Drug Administration
made reference

to any exchanges

respondence between

it and

on Regulatory Agencies
Representatives

of cor­

the Subcommittee

of the House of

Small Business Committee that

led to or bore on the decision to call

this

4/ Copies of all of the listed materials are readily available
Tn our files and can be resubmitted to FDA if they cannot be
found conveniently in the Agency's files.

ASI-PR 0001475

9

Conference.

It

is our belief that this

correspondence would clearly show that the
Conference was

called as

a partial

response

to inquiries made of then Commissioner Goddard
by Congressman John Dingell;
prompt remedial
Dingell;

that promises

action were made to Congressman

and that no such action has yet been

taken despite these promises
"on the record"

3.

of

and others made

by Commissioner Goddard.

All correspondence and,

any relevant FDA memoranda,
industry has

come

relating to what

to call the

sent on an informal basis to
resentatives

on May

6,

where possible,

1969.

"Ramsey proposal,"
industry rep­
For reasons

which still remain quite unclear to us,

no

further action has been taken on this proposal.
We are of the view,
that most of
implied by
comments

the questions

the

based on our experience to date,
and issues

foregoing inquiries

that follow,

raised directly,

or

and the more specific

are not susceptible of satisfactory

resolution without a true exchange of opinions on the subject
in a suitable,
reason,

though not unduly burdensome

forum.

For this

we respectfully urge the Commissioner to hear oral

argument on

the entire indirect food additives

"administrative

ASI-pr 0001476

10

problem.

Such oral

argument

is

permissible under Section

of the Administrative Procedures Act,

5 U.S.C.

it is

legislative

understood that conducting such

ceedings

is

the importance,

questions we are raising,

the Commissioner,

could be provided a reasonable time
and respond to

so as

full record,

to make a

which essential

issues

is

to explain-

the only sensible means

can be brought into

focus.

We,

presented with public problems

when other agencies

that SPI

are

of significant import,

do not hesitate

hearings or oral presentations
example,

there­

time provided for this purpose.

instances,

respective administrators

by

be allocated argument time

before the Commissioner for this purpose and request
be allotted one hour of the

where

the Commissioner's questions

that interested parties

In numerous

the

and the recommendations being made,

their positions

urge

type pro­

and long range impact of

we submit that such argument before

fore,

although

discretionary.

Due to

all parties

§553 (c)

4(b)

to

call

their

for public

on their own initiative.

For

the Federal Trade Commission ordered open hearings

to

explore modern advertising practices and their impact on con57
sumers with special attention to television advertising.
The
Environmental Protection Agency made provision for a public
hearing regarding the

5/ 36 Fed. Reg.
Appendix B.

16698,

issue of lead and phosphorous

August

25,

1971;

additives

attached hereto as

ASI-PR 0001477

11

6/
in motor vehicle gasoline;

and the Federal Communications

Commission has ordered oral

argument regarding the

"Fairness

y
Doctrine."
£/
Even

though the controlling

oral argument,
contribute

we believe

this

substantially in

law

does

not require

form of presentation will

'“his

instance.

It should be

noted that we are specifically not requesting an evidentiary
hearing pursuant to
our opinion,

5 U.S.C.

a hearing is

islative type of oral

§556.

not

In the present case,

required but we believe a

argument is

demanded to serve

in
leg­

the

public interest.

II
IN EFFECTUATING THE INSTANT PROPOSAL, IF IT
IS ADOPTED, DUE CONCERN AND CAREFUL PLANNING
SHOULD BE EMPLOYED TO ASSURE THAT REQUIRING
"GRAS PETITIONS" WILL NOT FURTHER OVERBURDEN
THE PRESENTLY UNSATISFACTORY PETITION PROCESSING SITUATION
As we read the present proposal,
require

the

it will most

assuredly

filing of a great number of additional petitions,

albeit and hopefully,

many of

6/ 37 Fed. Reg.
Appendix C.

3882,

February

23,

7/ 37 Fed. Reg.
Appendix D.

4978,

March 8,

1972;

8/ The relevant part of
Act, provides that:

these petitions will

1972;

require

attached hereto

less

as

attached hereto as

§4 of the Administrative Procedure

"...the agency shall give interested persons
an opportunity to participate in the rulemaking through submission of written data,
views, or arguments with or without opport­
unity for oral presentation."

ASI-PR 0001478

12

preparation and FDA review time.
the advisability of

adding to

time when it remains

Nonetheless,

we question

the over-all petition load at a

apparent that the petition-regulation

system is by no means operating as Congress

intended,

nor as

industry or the public have a right to

expect.

Indeed,

it

might be best to consider whether this

system should be re9/

tained at all before an additional burden is
The statutory time limitations
publications of Notices
Petitions
Food,

of any type within

Drug and Cosmetic

denial of a proposed
days

subsequent to

However,

of Filings

Act

placed on FDA require

regarding Food Additive

30 days

after filing

§409(b)(5))

filing of the Petition.

with few exceptions,

the

time

This observation,

(Federal

and the adoption or

food additive regulation,

the

tinuously exceeded.

placed upon it.

90 days

(§409 (c) (2)).

limitations
which

is

or 180

are con­

a general

w
basis of complaint by

industry,

has been acknowledged by FDA

9/ In many ways the present regulatory scheme is much more akin
to licensing than rulemaking.
Perhaps it is time to acknowledge
this frankly and proceed accordingly, accomplishing the neces­
sary public information function by publishing lists of "ap­
provals" given from time to time.
This could expedite matters
by allowing the FDA Staff to focus on specific substances for
specific intended uses instead of requiring that Regulations
be devised to anticipate broader coverages than Petitioners
require, or can even know about.
10/ At an FDA-SPI Seminar, held in Washington, D.C., on June 18,
1971, Mr. Nathanial Geary, then Director of the Division of
Petitions Processing of the Food and Drug Administration, stated
that the average time to process a "perfect" petition was 184
days.

ASI-PR 0001479

13

and was

further quantified to a degree

conducted by

SPI's Food,

in a recent survey

Drug and Cosmetic Packaging Materials

Committee.
The
from 19
direct

SPI

survey resulted in

petitioners

covering 129

food additives.

said prior to a 1966
there was

regulations

issued.

Based upon

the post-1966

relating to

these replies,

an average delay of 13
The

shortest times

half month for acceptance,
in another,

petitions

in one case,

but these were not

As

to

12

1/2 months per petition.

it can be

filings,

1/2 months before

reported were oneand

two months

for

for the same petition.

the average processing time was
The shortest time for promulga­

tion reported for a simple Regulation amendment was
months.

in­

internal FDA change in petition-processing

procedures,

issuance

the receipt of responses

four

Many responders reported petition-handling periods

of over three years.
filed since

1966,

Of the petitions

51 prior to

1966,

and

reported on,
the other

39 were

39

spanned

the pre-and post-1966 years.
Stated simply,

this

survey merely

confirmed the

knowledge that the handling of Food Additive Petitions
always

involves delays which make a mockery of the

requirements.

common
almost

statutory

IV

11/ It is acknowledged that some of the delay is due to re­
quests
by FDA for additional information but more often than
not these requests are not even received until the "last
hours" before a statutory deadline is due to expire.

ASI-pr 0001480

14

The issue of

time

limitations

naturally comes

to mind

in another sense in connection with the subject proposed
rules

since they will

require petitioning

GRAS

status of a given

for affirmation of

food additive substance.

the proposal does not mention time limitations
assume

the plan is

to

In this case,
so we must

follow the statutory procedures.

This

can only aggravate an already unacceptable situation and
make

further delays

as well as

the new

commonplace as
"GRAS"

According to
status

is

the proposal,

sought either on the

is

conventional petitions,

ones.

or upon the petition of an
a notice

to

when affirmation of GRAS

initiative of the Commissioner

"interested person,"

placed in the Federal Register,

must evaluate all comments
(§121.40(b) (3)

and

121.40(c) (4),)

or as

to

days

after

the Commissioner

received and make a determination.
However,

limitation placed on the Commissioner as
of the evaluation,

60

there is

regards

no

time

the making

the publishing of his decision

in the Federal Register.
Even though the already-existing processing time
limits

are so

serves

as

frequently exceeded,

their presence at

least

a reminder that a given regulatory proceeding should

not continue indefinitely.
respectfully
they should

Thus,

at the very

least,

submitted that if the proposed rules
include

Commissioner in

the expression of a

§121.40,

time

it is

are adopted,

limit upon the

especially with regard to petitions

ASI-PR 0001481

15

initiated by an outside party.
Accordingly,
as

SPI

recommends

that

§121.40 be revised

follows:
1.
In §121.40(b)(3) on the fifth line,
after the word "publish" insert the
following phrase:
"...within 90 days after publica­
tion of the notice in the Federal
Register referred to in subsection
(b)(1) of this Section,..,"
2.
In §121.40 (c) (4) , on the seventh
line, after the word "publish" insert
the following phrase:
"..., within 90 days after publica­
tion of the notice in the Federal
Register referred to in subsection
(c)(2) of this Section,..."
Ill
THE FACT THAT SUBSTANCES WHICH ARE NOT
DETECTED IN EXTRACTION STUDIES AT REASONABLE
LEVELS OF METHOD SENSITIVITY SHOULD BE READILY
DEEMED NON-ADDITIVES SHOULD BE MADE COMPLETELY
CLEAR; MOREOVER GRAS STATUS SHOULD BE PROMLTLY AND
EASILY GRANTED INDIRECT ADDITIVES USED IN AMOUNTS
WHICH ARE OBVIOUSLY OF NO TOXICOLOGICAL SIGNIFICANCE
The development of

formal procedures

status determinations proposed by this
be completed without resolving the
to eliminate

the excesses of

in cases where there is
migration of

to make GRAS

rulemaking should not

long-pending issue of how

full-scale regulation now afforded

no detectable,

indirect food additives.

or extremely

low level

More specifically,

it

is respectfully submitted that FDA should eliminate the costly,
burdensome and needless

requirement of

filing food additive

A SI-

PR 0001482

16

petitions
to

to establish GRAS or any other status with respect

substances

carcinogens)

(other than heavy metals,
which may become

very low concentrations.

incidental

and known

food additives

at

It is well recognized that even

potentially harmful materials
are harmless.

pesticides,

taken

It is on this basis

in minute enough amounts
that

the National Academy

12/
of Sciences

- National Research Council

guidelines as

to toxicological

has

developed its

insignificance which FDA is

already recognizing in determining the

safe

food additive.

law are required to be

Food additives

that by

level of use of a

regulated have dietary levels below which they have no adverse
effect,

the

"no-effect"

by regulations
extension of
underlies
formally

level,

and therefore,

are permitted

for use at that level and lower.

this philosophy

the so-called

to very

It is

an

low concentrations

that

"Ramsey Proposal," which SPI now

requests that FDA re-examine,

revise somewhat,

and

adopt.
To

review,

additives was
Regulations

this

proposed

and was

draft proposal affecting indirect
to amend

§121.2500 of the Food Additive

issued on May

6,

1969

as

an informal

12/ The Food Protection Committee-Food and Nutrition Board of
NAS-NRC issued a pamphlet, "Guidelines for Estimating Toxicologically Insignificant Levels of Chemicals in Food," in
1969 wherein it was observed that:
"for every chemical there
is some finite level, sometimes called the 'safe level'"-that level which refers to the maximum acceptable daily intake
in the total diet— "at or below which it can be present in
food without prejudicing safety."

ASI-PR 0001483

17

statement

for discussion purposes.

the proposal would make

The major provisions of

it unnecessary to

Petitions concerning components of

(1)

use in contact with Type VIII dry

foods

of

§121.2526 (c)),

(2)

articles

in paper and paperboard,

articles
(as

intended for

defined in Table

food,

(4)

(3)

defoaming agents

food packaging adhesives

complying with the good manufacturing practices
of

§121.2520

and

(5)

known carcinogens,
at 40 ppm.
studies,
less

or

or

those components

(other than heavy metals,

demonstrated by calculation,

food analyses to

extraction-

result in a transfer to

food of

than 0.05 ppm.
already been indicated previously,

and other packaging industries

are

in general

responsive

to some of

viewed as

a

the Food and Drug Administration to be
the problems

created by past

tion of the Food Additives Amendment of 1958,
incidental

the plastics

agreement with

thrust of the Ramsey proposal because it was

good faith effort by

to

requirements

and substances previously shown to be toxic

less)

As has

the

1

intended for repeated use in

contact with bulk quantities of
used

file Food Additive

food additives.

Further,

as

administra­

it relates

we believe FDA would

agree that some means must be

found

for delineating between

areas where potential hazards

to health may be

involved--and

therefore warrant the careful attention and great expenditures
of money,

time,

and expertise required

to clear products

food additive petition route—and those areas where

by

the

there is

ASI-Pr 0001484

18

no hazard to warrant such expenditures.
been our view that

this

Actually,

it has

long

type of delineation is precisely what

Congress had in mind when,

among other

limitations,

it de­

liberately restricted coverage of the Food Additives Amendment
to

any substance

"the

intended use of which results

reasonably be expected to result,
its becoming a component...of
This
shortly

is why

directly or indirectly in

food..."

the packaging industries commended FDA ,

after the May

viewed this

or may

action as

6,

1969 proposal was

a true attempt to

circulated.

comply with

We

the

implied statutory mandate to clearly distinguish between sub­
stances which should be within the purview of the Food
Additives Amendment and
of

food,

or otherwise so

receive only

those so unlikely to become components
insignificant,

such attention as

is

as

to demand that they

necessary

from unduly complicated regulatory coverage.
great dismay,

the provisions

been effected despite FDA's

to exclude them
However,

to our

in the draft proposal have never
continued acknowledgement of

their scientific soundness.
It is

a

fundamentally accepted proposition that

"to

provide assurance that any substance is
human or animal consumption is

absolutely safe for
13/
impossible.
Because of the

limitation of scientific manpower and

the priority of other

13/ 21 CFR §121.3 (ah

ASI-PR 0001485

19

national programs,
severity

factors

which pose
On this

health hazards

and available resources

the most

basis,

should be

significant problems

applied to

relative
those

to public health.

the public health protection achieved by the

present procedure of regulation of indirect
has

assigned

simply not

food additives

justified the vast expenditures

that have been

required.
In

the

fourteen years

Additives Amendment,
the toxicological
ever,

the

hazards

millions

testing of

findings have

since

the enactment of the Food

of dollars have been spent on
fc ;d packaging materials.

How­

established that potential health

from food packaging materials

are extremely remote.

Indeed the persuasive arguments put forth in 1966 by Dr.
14/
Frawley
have only been further reinforced since then.
For all of these

reasons we urge adoption of the

draft proposal or a reasonable modification thereof,
sound method to
funds

in

this

reduce the needless

area.

said draft proposal

J.

It is

as

1969
a

expenditure of time and

recognized that adoption of the

affecting indirect additives

in its present

form would implicity require the categorical clearance in
advance of substances with which FDA personnel may or may not
be

familiar.

We

further recognize

that this

aspect of

the

14/ American Chemical Society Symposium on Safety Evaluation
of Coatings and Plastics for Food Packaging, September 14,
1966.

ASI-PR 0001486

20

proposal might be viewed with concern by FDA's
To resolve this
the adoption of
manufacturers

apparent roadblock we would propose

a system whereby indirect additive users

could simply give official notice

sonnel prior to
is

toxicologists.

or

to FDA per­

the use of a given indirect additive,

when

it

anticipated that the indirect additive will be used in

concentrations

falling within the range of

By this means,

FDA could raise any questions

about such use

if it has

reason

to do

so;

"insignificance."
it might have,

and categorical

clearance without definition of what is being used would be
avoided.
With this

provision for giving FDA an opportunity to

review in advance any proposed use of a
there would no
0.05 ppm.
was

longer be a real need

as was

in

to set

the

limit at

the 1969 draft proposal.

This

limit

set lower than safety or economy required in order to

overcome FDA's
advance.
is

done

low level migrant,

reluctance

Accordingly,

submitted,

to

It is,
regulations

to clear unknown substances

the

limit can now be

safely raised,

it

0*5 ppm.

therefore,

our recommendation that the proposed

be revised now to

Add the

in

include the

following subsection

Affirmation of GRAS

following provision:

to proposed

§121.40

Status:

*

*

*

ASI-PR 0001487

21

"(d) (1)
Persons seeking the affirmation
of GRAS status of substances as provided
for in §121.3(e) and based on the criteria
set forth in subsection (d)(2) of this
Section may obtain such by filing at least
90 days prior to intended use the Short
Form Petition, Indirect Food AdditivesAffirmation of GRAS Status.
The Short
Form Petition shall contain:
A.
the names of the indirect
additive, trade and generic,
B.
the proposed use of the
indirect additive,
C.
the concentration in the
resuJtant end products,
D.
the concentration of additive
reasonably to be expected as a
result of the intended conditions
of use in the food, specifying the
type or nature of each food, and
the corresponding maximum concen­
tration reasonably expected, and
E.

other proposed limitations.

"(d) (2)
The Short Form Petition shall be
filed for:
A.
components of articles intended
for use in contact with Type VIII
dry foods (as defined in Table 1 of
§121.2526 (c)),
B.
components of articles intended
for repeated use in contact with bulk
quantities of food,
C.
defoaming agents used in paper and
paperboard,
D.
food packaging adhesives complying
with good manufacturing practices re­
quirement of §121.2520, and

A$I~pR

0001488

22

E.
components (other than heavy
metals, known carcinogens, and sub­
stances previously shown to be toxic
at 40 ppm or less) demonstrated by
calculation based upon reasonable
migration premises, extraction
studies, or food analyses to result
in a transfer to foods of less than
0.5 ppm."15/

*

*

It is our hope
favorably and in
is

long overdue

*

that these Comments will be received

the constructive
for the

Moving in the directions
serve

*

light intended.

The time

type of changes we are advocating.
indicated here will,

the best interests of the public,

we

submit,

the government and

industry.
Respectfully submitted.

General Counsel for The Society
of the Plastics Industry, Inc.

of Counsel:
Keller and Heckman
1150 17th Street, N.W.
Washington, D. C.
20036

15/ A proposed draft of a Short Form Petition is
to as Appendix A.

attached here­

ASI-PR 0001489

DRAFT
Appendix A

File Number
FOOD AND DRUG ADMINISTRATION

o
O'

Short Form Petition
Indirect Food AdditivesAffirmation of GRAS Status

o
o

H
0

a
a
1

w

1.

Name of Applicant

5.

Concentration in Resultant Product

2.

Address of Applicant

6.

Concentration
a.

Name of Indirect Additive

1.

a.

2.

Trade Name

in Food

Type or Nature
of Food

b.

3.
b.

4.

Generic Name

7.

Proposed Use

Signature of Applicant

Date

tn
<r

Other Proposed Limitations

Maximum concent­
ration reasonably
expected

NOTICES

16308
whether the suspension order should be
vacated or made permanent, and it none
was ordered by the Commission, the tem­
porary suspension would become per­
manent. The issuer filed a resnorue con­
taining denials of the allocations in the
temporary suspension order, but there­
after, without admitting: or denying those
allocations, the issuer stated that it did
not desire to have and it did not request
a heaiing, and further si ted that it un­
derstood that as a result of that decision
on its part the suspension will become
permanent.
In view of the foregoing, it is appropri­
ate to enter an order permanently sus­
pending the exemption.
Accordingly, it is ordered, Pursuant to
rule 261 of regulation A under the Securi­
ties Act of 1933, that the exemption from
registration with respect to the orlering
of securities by Lov'n Leather, Inc. be,
and it hereby is, permanently suspended.
For the Commission, by the Office of
Opinions and Review, pursuant to dele­
gated authority.
[seal]

_

Ronald F. Hunt,

Acting Associate Secretary.
[FR Doc.71-12107 Filed 3-24-71:8:48 cm)

MODERN

ADVERTISING

PRACTICES

Nonce of Public Hearing and
Opportunity to Submit Data or Views
Notice is hereby given that the Fed­
eral Trade Commission, pursuant to the
Federal Trade Commission Act, as
am-tided, 15 U.5.C. 41. et seq , will condUv t open hearings designed to explore
modern advertising practices and their
impact on consumers, with special at­
tention to television advertising.
The hearings will involve neither re­
view nor evaluation of specific advertis­
ing representations or claims in terms
of their possible violation of the law.
Individual questions of advertising de­
ception cr misrepresentation will con­
tinue to be dealt with by complaint or
rulemaking procedures. The hearings
will attempt to i licit empirical informa­
tion from a wide variety of authorities
regarding a number of aspects of ad­
vertising. The Commission’s current pri­
mary interests are the following:
Children. As a class, children have
always been the subject of the special
protection of law. Underlying this
proposition is a recognition of the vul­
nerability of children to suggestion, and
their immaturity of judgment. This spe­
cial protection afforded for children in­
cludes protecting them as consumers or
television viewers. The unique aspects
of television may provide compelling
reasons for arguments that special
standards should be developed in the
regulation of advertising addressed to
children. In order to better acquaint
itself with the considerations involved
in developing such standards, the Com­

mission desires to explore how children
learn, perceive, and make decisions.
Advertising themes. The Commission
desires to infoim itself about the ex­
tent to which some advertising may
appeal to such ft ts or anxieties as so­
cial acceptance or personal well-being.
Technical aspects. The Commission
desires to inform itself about whether
and how certain photographic and other
techniques used in making TV and other
commercials may make use of nonverbal
persuasion which may not be recognized
by viewers.
Physical, emtionat and psychological
responses. New methods of advertising
may be causing effects in viewers dif­
ferent from those customarily generated
by advertising. The Commission desires
to learn about consumers' physical,
psychological, and emotional responses
to advertising.
The hearings will be for informational
purposes only and will not be geared to
the ad-: mn of a rule or other form
of guici- tie. Whether future Commis­
sion act‘on wall result from the infor­
mation developed will depend on the
facts obtained from the record of these
hearings.
All interested persons, including the
consuming public, having information
based upon empirical date, or other ex­
pertise, are hereby notified that they
may file written data or views concern­
ing modern advertising practices with
the Director, Bureau of Consumer Pro­
tection, Federal Trade Commission,
Pennsylvania Avenue and Sixth Street
NW.. Washington, DC 20530. To the ex­
tent practicable, persons wishing to file
written presentations m excess of two
pages should submit 20 copies
All interested parties are also given
notice of opportunity to present data or
views orally at the public hearings to
be held 10 a.m., October 20, 21, and 28,
1971, in Room 532 of the Federal Trade
Commission Building. Washington, D.C.
Any person desiring to present his
views orally at the hearing should so in­
form the Attorney-Advisor io the Chair­
man not later than September 15, 1971,
and state the estimated time required for
his oral presentation. Reasonable limita­
tions upon the length of time alloted to
any person may be imposed. In addition,
all parties desiring to deliver a prepared
statement at the hearing should file such
statement with the Director, Bureau of
Consumer Protection, on or before
October 1, 1971.
Notes: (l) Depending oa the geographical
location of tho-e persons desiring to present
views or data orally, the Commission will
consider holding hearing; in. location; other
than Washington, D.C. Notice of hearings
scheduled for locations other than Washing­
ton, D.C , will appear m the Fedskal Register.
(2) Because the duration o! the hearings is
contingent on the number of person; wish­
ing to express views cr data orally, the public
record In this proceeding will remain, open
until further notice appears in the FtossAa
Register

The data or views presented at the
hearings or filed for the record will be
available for examination by interested

APPENDIX B
parties at the Office of the Assistant Sec­
retary for Legal and Public Records, Fed­
eral Trade Commusion, Waslungto.i
D.C.
By direction of the Commission dated
August 17, 1971.
[seal]

Paul M. Trceslood,

Acting Secretary.
[FR Doc.7l-]2415 Filed S-24-71;8:49 am]

TARIFF COMMISSION
[TEA-I-22]

CERAMIC ARTICLES, INCLUDING
DINNERWARc
Notice of Change in Scope of Investi­
gation end Rescheduling of Hearing
■Following receipt of cDmmu.iic'-i'jas
filed by the American Dinners ate T.i.iergency Committee and the America. Fins
China Guild on August 17 and 19, r* ..pectively, the U.S. Tariff Commission, on
August 19. 1971, amended the scope of
investigation No. TEA-I-22 under sec­
tion 301(b) of the Trade Expansion Act
of 1962 (36 F.R. 11617).
The investigation, as amended, is to
determine whether, as a result in majo
part of concessions granted under trade
agreements—
articles chiefly used for preparing, serv­
ing, or storing food or beverages, or food
or beverage ingredients, ail the foregoing
of fine-grained earthenware, of fine­
grained stoneware, of chinaware, or of
subporcelain, and provided for in items
533.14 through 533.77 of the Tariff Sched­
ules of the United States, inclusive, but
excluding item 533.51 thereof,
are being imported into the United States
in such increased quantities as to cause,
or threaten to cause, serious injury to the
domestic industry or industries produc­
ing articles which are like or directly
competitive with the imported articles.
Notice of the investigation was published
in the Fsdss.vl Regists?, of June 16, 1971
(36'F.R. 11617).
Public hearing rescheduled. The public
hearing ordered to be held beginning
September 14, 1971 136 F.R. 14632), is
rescheduled to begin at 10 a.m., e.s.t., on
November 30, 1971, in the Hearing Room,
Tariff Commission Building, Eighth and
E Streets NW , Washington. DC. Appear­
ances at the hearing should be entered
in accordance with 5 201.13 of the Tariff
Commission’s rules of practice and
procedure.
Requests to appear must contain a
careful estimate of the aggregate tune
desired for presentation of oral testi­
mony by all witnesses for whose appear­
ances the request is filed.
Issued: August 2(1.1971.
By order of the Commission.
1 seal 1

Kenneth R. Mason,

Secretary
1 FR Doc 71-12410 Filed 8-24-7t;S.4D ami

F;Q;3Al. REGISTER, VOL. 36, NO. 165—WEDNESDAY, AUGUST 25, 1771

ASI-PR 0001491

APPENDIX C
PROPOSED RULE MAKING

3SS2

regulate the lead content of "regular” the significance of airborne lead as a
and "premium” lead'-d gasolines by pro­ health hazard. Additionally, com.'.'.:'.As
viding for the reduction of lead over a are requested on the regulatory oppronh
4-year period, beginning January 1, 1974. proposed herein and on possible alterna­
It Is the Agency's judgment that these tives which would achieve the same re­
t 40 CFR Part 80 ]
reductions, together with the introduc­ sult. Comments on any such alternative
tion of one grade of lead-free gasoline, should be accompanied by infonr.at.cn
REGULATION OF FUELS AND FUEL
as proposed herein, v.ill provide for the on its cost-benefits and other effects.
ADDITIVES
protection of health m mr.ior urban areas
Among other things, these regulations
v. ithin the shortest time reasonably pos­ set forth certain labeling requirements
Lead and Phos .'lorus Additives in
sible.
Copies
of'a
summary
and
analysis
Motor Vehicle Gusoliri"
applicable to gasoline retailers. It is the
of evidence on health hazards of air­
On January 30, 1971, advance notice of borne lead, entitled "Health Hazards of Administrator’s intent to coordinate such
proposed rule mi!:ir,; was published in Lead," are available from the Publica­ requirements with the Federal Trade
the Federal Regis .'Er (3G F.R. I486) to tions Section, Environmental Protection ConunLcsi jn.
Intel ested persons may submit writ­
inform the public that tile Agency, in Agency, 5600 Fishers Lane, Room 18Bten comments on the proposed regula­
accordance with the reqmremeiv of sec­ 03, Rockville, MD 20352.
tions, in triplicate, to the Deputy Assist­
tion ' 11 of the Clean Air Act, as . lended
The Administrator has considered
<42 U.S.C. 1857 et sen.), was r< isidering whether it would be more economically ant Administrator for Air Programs, En­
available relevant scienti So, meuical, eco­ and technologically feasible to provide vironmental Protection Agency, 5GOO
nomic, and technolor.ii,.’ data concern­ for the protection of public health by Fishers Lane. Room 17-59, Rockville,
ing the uve of lead and: • cs in motor ve­ means of a rew motor vehicle emission MD 20352. All releva" t comments post­
hicle r.aso'.nes, with tue intention of standard for lead particles than by marked not later than 90 days after pub­
proposing
" -jr prohibitions on the means of the proposed reduction of gaso­ lication of this notice will be considered.
Comments received will be available for
use of the
dud.' es on the earliest date line lead content. It is considered uc
public inspection during normal working
possible.
likely, however, that new motor vehicles
After considering available scientific could be equipped with lead emission hours (8 a.m. to 4:30 p.m.) at the Office
and economic data, including a cost- control devices prior to V ' 1975 model of Public Affairs, Waterside Mall, 401 M
bern.r.; analj-vis comparing motor vehicle year, it is anticipated tlr new vehicles Street 3W., Room 3241, Washington, DC
20450.
emission < ruitrol devices or systems which will be equipped with ei. ■ ion control
The Act provides that if a manufac­
are or will be in gemr. 1 , -,e and require systems requiring the u.: of lead-free
control or prohibition of !-ad additives gasoline; thus, imposing a lead emission turer of motor vehicles, motor vehicle
in gaso’nes with eimrsion i ■ .iiol devices standard would produce no benefit, in engines, fuels, or fuel additives submits a
or sysi as which are or will be in gen­ terms of lead emissions. Furthermore, written request for a public hearing to
eral tin '.nd do not require such control the Administiator does not have author­ the Administrator within 10 days of the
or prod
tion o‘ tho.' additives, the ity to prescribe a lead emission standard publication of this notice, the Admin­
Admin,.-, ior he d, 1 i mined that emis­ applicable to other-than-nsw vehicles. istrator will call a public hearing and
sion proclu.' of 1c. ... additives wall im­ Accordingly, the Administrator has de­ subsequently will publish findings with
pair to a sn 1 ilcjnt, degree the perform­ termined that providing for the protec­ respect to the matters he is required to
ance of etnissi,
centre’ systems that tion of public health by means of a new consider under section 211(c)(2)(B) of
include catalytic converters which motor motor vehicle emission standard for lead the Act. However, because of the signifi­
cance of the proposed regulations, tie
vehicle manufacturers are developing to is not feasible.
meet 1975-78 motor vehicle emission
The Administrator finds that prohibi­ Administrator has decided to call the
standards and are likely to be in general tion of the use of lead additives and public hearings. Tire particulars concern­
use if lead additives are controlled or pro­ phosphorus-containing additives and ing the hearings will be annour -ed in
hibited for me in certain motor vehicle the reduction of gasoline lead content the Federal Register at a later date.
This notice of proposed rule making
gasolines. The same considerations were will not cause the use of any other fuel
given, and the same determination was or fuel additive that w.;i produce emis­ is issued under the authority of section
made regarding the use of phosphorus- sions which will endanger the public 211 of the Clean Air Act as amended
containing additives in motor vehicle health or welfare to the same or greater (42 U S.C. 1357f-6c, section 9, Public Law
gasolines.
degree. The bases for this finding are 91-504; 04 Stat. 1958).
Therefore, It is proposed to provide for set forth m a paper entitled “Effects of
Dated: February 17, 1972.
general availability by July 1, 1974, of Reduced Use of Lead in Gasoline on Ve­
essentially lead-free and phosphorus-' hicle Emissions and Photochemical Re­
William D. Ruckelshavs,
free gasolines of an octane quality suit­ activity," copies of which are available
Administrator,
able for 1975 and subsequent model year from the Publications Section, Environ­
Environmental Protection Agency.
light-duty vehicles. Copies of the cost- mental Protection Agency, 0600 Fishers
A now Part 80 would be added to
benefit analysis referred to above, en­ Lane, Room 18B-08, Rockville, MD
Chapter I, Title 40 of the Code of Fed­
titled Aerospace Report, PB-205-981, are 20352.
The Administrator is also considering eral Regulations, as follows:
available for $4.50 each from National
Technical Information Service, Depart­ the need for limiting the sulfur content
PART 80—REGULATION OF FUELS
ment of Commerce, 5285 Port Royal of gasoline because sulfur may have an
AND FUEL ADDITIVES
adverse effect on the performance of cat­
Road, Springfield, VA 22151.
alytic
emission
control
systems.
Accord­
Subpart
A—G&n&ral Provision!
Based on the available evidence, the
Administrator has concluded that air­ ingly, the Administrator invites com­ 5=-?.
80.1
Scope.
borne lead levels exceeding 2 micrograms ments concerning the effect of various 80.2
Definitions.
per cubic meter, averaged over a period levels of sulfur concentrations in lead- 80.3
Ti'jt methods.
free
and
phosp’
n
orus-frco
gasoline
on
of 3 months or longer, aie associated with
80 4
Right or entry; touts and insmoctioi’-S.
a sufficient risk of adverse physiologic such emission control systems: the max­ 80 5
Penalties.
imum
level
of
sulfur
which
can
be
toler­
effects to constitute endangerment of
Subpcrt
B^Confrols and Prohibitions
ated
if
the
catalyst
is
to
function
prop­
public health. Since airborne lead levels
to
gasoline
applicable
in many major urban areas currently erly: the impact of a sulfur limitation 80 20 Controls
refiners.
range from 2 to somewhat over 5 micro- on the petroleum industry; and the
80.21
to
gacoline
Controls
applicable
grains, and since motor vehicles are the impact of a sulfur limitation on motor
distributors.
predominant source of airborne lead in vehicle performance and the cost of gas­ 30.22 Controls
to
gajolice
applicable
such areas, attainment of a 2-micro- oline to the consumer.
retailers.
gram level will require a GO to 65 percent
The Administrator specifically invites CO 23 Liability for violations.
reduction in lead emissions irom moLor all interested parlies to submit infor­ 80 24 Controls applicable to motor vehicle
manufactuters.
vehicles. The Administiator proposes to mation reflecting their interpretation of

EM0ift3E:iTAI PROTECTION
AGENCY

FEDERAL REGISTiR, VOL 37, NO. 36—WEDNESDAY, fECRUARY 23, 1972

A$l”

pR 0001492

APPENDIX D
NOTICES

4‘»7o
inetii.iiirt rates are foiecast to raise Air­
borne's icysnucs for that year by $1.2
m;'i on, o’" an average of 1.45 percent.
3 Ti1? increaied rates are forecast to
reoilt in a profit margin before taxes of
2 f.S prieent of revenues, as cornp'.red
with 5 ‘.Ci percent for tiro first 11 me: liis
of 1971,“
4. The record provides sufficient evitlea.ce to cor.clavie that:
a. The increase proposed is cojt-based
rnd does not reflect future mffitionary
expectations;

b. The increase is ths minimum re­
quired to assure continued, adequate, and
safe service and to provide for necessary
expansion to meet future requirements';
c. Tht increase v:ll achieve the mini­
mum pro.it margin to atti\ / capital at
reasonable co^ts and not m.p.dr Air­
borne's credit *
In View of the foregoing considerate as.
the Board linos that there is no b.^,s to
continue the investigation previo.dd7
initiated in this docket and accord:: jiy
it will be disrni:- ed and the suspension
vacated. *
. Accordingly, if is ordered. That:
1. The suspension of increased rates,
charges, and provision-, in Order 72-1-25,
dated Jan* --7 ll, Itin Docket 24110
is vacated and the 1
.stigalion insti­
tuted in that docket
dismissed; 7
2, A copy of tills ore: r shall be filed
v/tth the taritfs and served upon Airborne
Freight Coip.
Tills order will be published m the
Federal Kcgistsh.

By the Civil Aeronautics Board.
[seal]

Hahry J. Zinn,

Secretary.
[TH Doc.72-3493 Filed 3-7-72,8:59 am]

4 These are the figures in the pet1 Mon for
reconsideration. In a letter ampluym.g it3
original justification, Airborne forecast that
the profit margin for 1972 before taxes would
otnount to 2 72 percent of revenues after the
rate Increa>-_, while the figure without the
rate incre^w would be 1 40 percent.
4 The Board has not heretofore established
a rate or return for airfreight forwarders and
has not deemed It appropriate to do so, in.
view of the Board’s long-standing policy of
free entry Into the air freight forwarding
field and the resultant forces of competition
which operate on the many entrants In this
field. Accordingly, we are not In a position
to apply a rate of return analyst: :o this seg­
ment of the air transportation industry.
* On the basis of information before us.
It appears that if the increases here sought
were not permitted the profit margins which
would result would be substantially below
tnat other freight forwarders will achieve,
and this fact would be relevant to potential
lenders of capital, Accordingly, we conclude
that the profit margin here sought is not

excessive.
‘Tiie Increases rate?, charges, and provitlfii-. permitted by this order will be cttecUve
vip'm che filing of appropriate tariff revisions
as required by Part 221 of the Roaids econo-iuc regulations but on. not less than 10
d.i^ >’ notice, and in no case be effective prior
to M.irch 10, 1072 unlevs otherwise peunitted
by ttv? Uor.rJ.

FEDERAL COM?i!CATiO?l$
COMMISSION

be of benefit m the complex faum“ss

area,

3. Rne issues for panel discussion will
be as follows:
P*ET II

(Docket No. 102f>0, FCC 72-207]

FAIRNESS DOCTRINE AND PU3LIC
INTEREST STANDARDS
Order Regarding Oral Argurvvnf “En
3tmc" and Handling of Public Issues
In the matter of the handling of public
issues under the fain;' . docti ine and the
public interest standards of the Com­
munications Act, Docket No. 15260.
1. On June 11, 1071, the Commission
released its Notice of Inquiry in this pro­
ceeding in; . mtirsg a broad-ranging study
of ths Fairness Doctrine and related pub­
lic interest policies (36 F_R. 11825). We
divided the Inquiry into four parts;
H. The- Fairness Doctrine Generally.
tit. Access to the Broadcast Media as
a F-esult. of Carriage of Product Com­
mercialsIV. Access Generally to the Broadcast
Media for the Discussion of Pu. .be Issue .
V. Application of the Fairness Doc­
trine to Political Broadcasts.
Ey March 15, 1972, we expect that all
comment.; and reply comments will have
been submitted in response both to the
June 11, 1971 notice of inquiry (36 F.B.
11325) and our further notice of inquiry,
released March 2, 1972, requesting com­
ments on the isjue (under Part IV of
the June-11 notice of inquiry) of access
under the public interest standard of the
Communications Act.1
'
2. We indicated in the June 9, 1971,
notice of inquiry that, in view of the
importance of the subject matter, we
intend to employ special procedures to
assist us in resolving the difficult issues
involved. We have decided to utilize both
the custom:.:y oral presentations to the
Commission "en banc" by interested
parties or their representatives and, in
addition, a series of panel discussions by
knowledgeable persons directed to some
of the important questions presented by
our two- notices and the responses to
these notices winch we have received-We
are following this course because we
found it to be of substantial benefit when
we utilized it for the first time in con­
nection.,-with the proceedings on cable
television. (See orders released Febru­
ary 4, 1971, and March 8, 1971. in "Com­
munity Antenna Television Systems,”
Docket No. 18397—A et
27 FCC 2d 303,
27 FCC 2d 932). In that proceeding we
embarked upon the novel ^course of
using panel discussions as a mechanEm
for sharpening the issues in the give and
take of a form of discus.,ion which is not
available in the normal oral argument
form of presentation. Since the panels
fulfilled our expectations in the cable
television proceeding, they should also
1 The further nohee of inquiry stated that
cqm.men.LS o:i Part IV should be directed to
thd statutory public interest expect of acce.s
rather than constitutional .arguments.

FSD-2U a = Ci;T:7, VOL. 37, NO. <6—WEDNESDAY, MATCH

1. Is the Fairness Doctrlre serving ius basic
purpose of promoting robust, wide open, acd
reasonably balanced debate on impor. i
public ksues9 Does ic. in practice, encou--* ■*?
or inhibit the presentation of contro--'-v j
prograr.'’
Does it. in. practice, cor.SN/i/.e
undue Government Intrusion In hcec-ee
discretion or, on the contrary, Lnadenune
Government assurance that controversial
Issues are co'ered and covered falrlv? Wnat
changei.. If any, should he made by the Com­
mission or by way of recommendation.* ;o
Congress (i c . what snecLfic statutory amend­
ment-? are required) 7
2. If the Fairneaa Doctrine la funda­
mentally iiouncl, v/hat policies and procedures
could be institu* <-* to improve it* efilcacr?
(a) What poU:’ and procedure should b*
employed by the Commission, in determin.-osy
whether a complaint warrants referral co
the licensee? Y/hat burden should be placed
on the comp' 'innt to. make a. showing ot
unfairness b tf^”rrr the licensee ’s ohiiffamj zo
demonstrate compiniEU with tha Fairness
Doctrine (io, “hct‘« . to Mr.- Allen- Phelps,**
21 F.C.C. 2d 12 (19 .'■})?
(b) What policy and procedure-should beemployed by the Coinnviidon in determining
whether the licensee* h
horded "reasonable
opportunity for the tU
^;oo of conflicting
views on i:suas of pubLc importance" (5»*c*
tion 315(a)) 7
Should the license* be required to fum . h
recordings or iraoscrlpts of all program
matter (Including all pertinent news icema)dealtng with the Uaue in on nioa over 3^
considerable period of time?"
Should the Commission estab.
* some
minimum ratio of viewpoint to \ iwpomwhich is necessary to achieve fairness («e„
2 to 1, 3 to 1„ 5 to 1, etc.)'’ Is any such
"stop-watch" technique app‘^ -jrtate?
Can the Commission accurately review a
licence's judgment as to how programing
segments should be categorized. (eg., pro,
anti, neutral) ?
Should factors other than quantity of time be considered (eg., frequency of presenta*tion, probable audience for the time periods
employed, timing of the broadcast in rela­
tion to the crucial event involved, ie,. elec­
tion, decision, %’ote, etc.) ?
Should the Commission instead adopt a
test of whether or not the broadcasting audi­
ence of a particular station has been afforded
the opportunity of being reasonably in­
formed. on an overall basis, on issues- of
public importance (e.g., "Green v. F.C.C.,'*
447 F. 2d 323 (D.C. Clr. 1971))? If So, how
should such a standard be determined and.
applied?
(c) \Vhafc policy and procedure should theCommission employ In ruling on Fairness
Doctrine complaints?
How should the Commission determine
whether a controversial Issue of public im­
portance is Involved?
Should there be a time limitation of filing
falrnes.? complaints against a licensee and,
if so. how long? How v/ould such a proce­
dure worl: with continuing issues?
Should the Commission defer action on
fairness complaints until renewal, at which
time the Commlsslo
would consider the
licensee’s overall pe'aormance? Can revised
renewal policies and procedures (eg, such
as those proposed in Dochet No, 19153) con­
tribute in any va7 to insuring compliance
with the Fairnors Doctrine*
V/ould periodic reviews p.t intervals shorter
than 3 yj.-’rs be preferable and. If so, how

long?

1 77 2

ASI-PR 0001493

NOTICE
If ,ny ourti "ciofCTTcd lulls"" pro'-.dcro
ho v ‘O'dd LdrnO’>i» be Li^iu - on.

indr. iCmM 1-oU': 1
ij^O'dri a:i e^oepiioa be m.run- for
nj\“-s,r> (i>^.. e>w;l-»r.5l referea^i, efc.),J
(cl) Dw’-js ‘he cLctru-.c dfiril effectltcly \vUh
b*i f, p"rlr'r!r‘’cr subjidi'iry reieroncr* 'O

z. cv'Uu.y’-j-'O jo.vter rt g., "In Re m;u-.n.
bv NUU L r r ^cons’cV
*on of p.ulmj i ..»g'.-Ciiv; Aircrift 0./0"f.. ?,ad R 'ot* A*,»oclatiou.” n,
C 2.1 733 (i970/) 9
(o) f)o t«3 yy'oorv.l att«*.c% u.:d editor.‘ilLilng rii’.ej serve tb.ff’P intended purpose O"
(J > tir:y inhibit fr'i* and op?n riisca^stoa?
Vn:,' t h..:,"^ 11 m.y, should he mede
witii rev:,-.!, to tbJ licensee's aL'irmati'.'e obI.j'tlcu to e:.cr:v"e and irnpw.-ier.t the
pieSRW.W.on of contrr.-^ing v-.*'.points0
(g) a -.on.ld th? "Cui’nii.n doctrine (C’.Llmii.i 3ron.de;.iatiiig Co.." ‘0 jP.C.C. 573 (1U” 3>)
be exploded or restricted in any way?

(h) Should, the Commission. Impose ferrfeUuros for rairno'-i Doctrine violations?
3. Docs the Fairness Doctrine seme the
public interest in if* application to news?

4. Is tns Fcumsso Doctrine neceso\ry tot
nil categories of nioadcavw licensees?
5. What is the relatoj^-hlp of this part
or the inquiry to the o:her parts? SpecldcoAly. what policies, if any, corcermqrj access
to the brcadc.i^t media cuqhr. properly and
feasibly be evolved uodvr the public interest
ssjuid ird of the Commanic&siozis Act, aud
what v.ould he r.heir relationship to, r-nd
effect upon, present or proposed Fairness
Poctrb -• poUc.es"3 *

Past nr
SKSCC OtTZSTTO.VS
1. Under the Fairness Doctrine, or p.lfernc.tlvely a public interest standard, sh • i'.d
time—either on a free or paid basu
e
afforde- by the broadcaster for the earn. ir;e
Of so-called comitercommercials or other
countcrcomm^cial programing?
2. Would ' ■ purposes of the Fairness Doc­
trine, day.
ns it is to Illumine sigri-}ennt coatro. j'S’.al Issues, be served. by re­
quiring countjrcommerciais? 1$ the public
interest so served («? 5., do spot announcemeats add sufcjtantlcUy to pubbe knowledge;
is repetition z sign Scant factor to be con­
sidered) ?
srrccic qijrs-nois's
3. If the broadcaster sells time for the
promotion of products and services, must hs
a'^o *v\\ time to tho^e who wish to nt-gue
aictirxst pu’obc use cf the^e s?.tne products
or serncee (cl., “P.et'ul S;cce Etniployee^ Un­
ion, ‘Local GSO v F.C.C
436 F. 2d 248 (D-C.
Clr. 1970)) ? I' so, wrvat v/ould be the pre­
dictable effect on the continued carriage
o! piocluct commercials and thus on the
continued econcmx health and growth of
the commercial broadcastmg system? If nott
vubat v/oaid be the predictable effect oa the
public Interest?
4. Should the "Cigarette' Advertising'' rul­
ing: (q F.C.C. 2d 921 (1367). aff'd, "Banzhaf
v, F,C.C./‘ 405 F. 2d 1082 (D.C. Clr. 1963)
c*rt den, sub nom. “Tobacco Intsttute v.
F.CC; 3D6 U.S 812 (1963)), Idvolvihg free
tima, b-“ expanded to cover additional prod­
uct commercials or should It be abandoned?
If ti e former, what would be the predictable
on the continued broadcast carriage of
rrndvet comnerciiiij ancl thus on. the eco­
nomic heal til mid growth of the commercial
br^ rn'cauting
stern? V/lrit v/ouui be the ef/t»ct :i codiih-wcial time were reduced, for
i, by 20 t, ■;(.--nt to accommodate
co’.me-romm r'ol *.s"> If the latter, v/hit
v-wnhl ne the prrcuctab’o cheat on t'o.e nv.bLc :„*rcst? 3o. niLI ‘ Ch^rette A Iv^rtising’’
ho rephicod by
1 ne atterhatt^c policy iiucl,
\i :o, ■-perlfically r/h.tt poUcy0

5 To tiiere s-v:vv W'-./V a j’e otandaid for d‘3tl
ishln:; v.i.vii Cat“;:or*.^i of product
c JMrv’ro!
tn ■
“Ctjar ,fb Adv^’d’.slfu;“ v/01:1 t or would no*, apply'1

i\o, 45----5

(a) For examp’e, shs.;M it zp?\j only to
cohmiercicU. ^ luch e-.p’Ul:y p:
arr,uiren^vt on controvcr-hd
of public
importance?
(b)
to all other C1T.re.Tl.1i5, should
tn.i're be a presimiptibh t':;..: product adverdo nut rcioe cc-rrroverM.u ux>u^-i of
pubhc importance, a preiumption which
would be rebuts i he only by compelling evi­
dence to the contrary?
6 A'^stUiiing the applititic-h of the Fairiicjs
Doctrine
to product
cominercsal^,
s'.iO’dci it apply only to the text of the
advertisement or al:o to any coutrvv^my
surrounding
the
Uj&
c!
the prexiixt
aclve:- ..vd"3
7. /-rc new cr didc-ent FCC standards re­
quired in c&tuuctioa v’t' ' ...l^e or
Lug adverfr'.i.ng'1 What rr.o ..ab« the ec'ect of
consumer complaints, cr the ft Lug of a FTC
cora-plalnt, that a partlcsl.-r advertlsemc*ac is
In scans way frds^ or misleading?
8. Are there any methods of providing
“nccsis" for the dlscus^on of countercommerclai content other than requiring accest­
ance by licensees of mdiriduai countercomtncrciais (e g„ requiring blocks of time fordid*
cussion-format programs on commercials)?
9. Should the “Cullman” doctrine be ap­
plicable to countered mm e m i als th?mseiv«
or other councercommercial progrrimihg'’
10 What specific ConstlvUt'.oaal comc?ratlons, L? any, ore relevi-at to this part of the
inquiry?
Fa-ht IV
Our pcalUcn ha:n has been, tst lorth In an.
order and further notice, itsuetl March.3, 1972
(FCC 72-154), C ■ ^deration Of the CorutN
tuttonal issues a* mg from the Court'.*, de­
cision in “Buciness Executives* Move for
Vietnam Penca v, FC.C.,"___ ___ U.S. Aon.
D.C. ............ . 450 F. 2d £42 (1371) (see para­
graph 4 o? the further Notice of February 3,
1972) must await the Supreme Court'.! de­
cision. indeed, we have made clear that the
entire Part IV access area may he resolved In
Light of the Supreme Coitcts action. V/e have,
however, afforded interested parties the op­
portunity to ?dwx?e cons’d-r v.ons germane
to access under the public merest standard
p.r.d their relation to present cr proposed
Fairness Doctrine polio.es. (See order and
further notice, paragraph 2, ICC 72-194:
paragraph ID, *-otlce of inquiry. FCC 71-623).
We believe that the oral procaedmg* should
also afford an opportun.tv to address this
issue. We therefore have included it in the
general fairness panels (see Question 5,
Part II),
PfR T

V

1. Should the Commission revise or clarify
its interpretation of the Fairness Doctrine
with respect to Presidential appearances (see
“Democratic National Cor mit’ee. et al./’ 31
FCC 2d 708 (1071), aff'd, “Democratic Na­
tional Committee v. F.C GV’_______UJS. App.
D.C._____ ___________ F. 2d ............ . Case No.
71-1637, decided February 2, 1972)? Should
any such revision or clarizcation ba extended
to other important public officials (e.g.. Gov­
ernors, mayors, etc)?
2. Should the quasi-equal opportunities
approach (e 5.. “Letter to Mr. Nicholas
Zapple,” 23 F.CC. 2d 707 (1970)) be re­
stricted or expanded, and what is the feasi­
bility ar.d effect o' any proposed revision on
the underlying policies of the stature (see
section 3 13(a) ) ?
Should the Commlrsion. adopt a pOoitlon.
that ' Zapple” applies only to political cam­
paigns and not to other
Should *,Z?ppU” be disasbOC'.ated iron\ the
Fairnes? Doctrine and incorporated laco r*ctio'A 3La7
Should “Zipplc” be
by applying a
7-clay deadline for requestirg “quasi-equai

opportuniclc-i”?
Should “Zapple” continue to apply only to
major parties (sea “Letter to Lav.Tence M. C.

4979
Smith.“ 25 T; F 291 (p-^.l)), or should it h_'
c.'.:uv.l'd to "'ll p^.r' -n or to some
ir"i‘lea!Iy dt-^ra^d ofvqo-y o' “partis v.rh
sub'-i int'z.'.
cupp"'.-"/’ (eg., por*;^.at-vy•:
of prjpu!-»r ot_*) i Ifo.v rhouid it ?pply to
“new” p arci-.
Should ‘Zapple” b>* c-tend^d lo Include
spo-esmen to: bailee L-uies such as bond

issues, arucadrae.vs of state e'ju.'h'LUtloos,
etc ?
3. What us tim effect c: the he*v Federal
Carr.p \ign Spending Abt (Faibi’c Law 92-225)
on political broadLV
(aMd part*-u.arly ^ectlou 1031a) (‘2) (A) of the Acs which require*
broadcast hcen.aees to aUo-.v rea^onabla acc-^o
to the’,- facilitiej by c\r.didat'-s for federal
clect1.'*^ office)?
•4, V/hat snould the ConuTUsslca do to en­
courage the u.desc, possible coverage of polit­
ical ciu:pi\i;,T.j’
a. What should the Commisoion do to
Tester free time for political oroadcoaU?
What Commission rule revisions, if any,
would be helpful'5 What statutory amend­
ments, If any. would oe n-ece-i^ary?
b. A-re ther«f conjstructlo::.' of the news
exempcioua in section 315(a) that are avail­
able to the Cammdaslau az,d would further
the jjoal of enhancing appearances by politi­
cal candidates?

4. In order to avail mirselv^-s of a wide
ran^eof views by kno'.v^ge^L'e person^
from both within and tvitK^ut the in­
dustry. *va will select panelists by invita­
tion. To a considerable extent, ve shall
talie into account the filings of inter­
ested persons or m*oups in making our
selection.
5. As stated, above, we also expect to
hold an ”en banc*’ oral argument in
which all interested persons T7ho have
hied comments or reply comments may
participate. Persons wis: ny to be heard
should su‘ mis notices of appearance
vnthm 5 days of the release of th.s ordc^,
sfatmy whether they wnh to address all
of the fo'ir mam subjects referred to m
paraiyraph l above or, if not, which of
the four areas they intend to address.
Parties vnch a common viewport aie
tirged to select a single spokesman in
order to avoid unnecessary duplication
of arguments. The Commission, by
further order, will specify the order of
appearance of the participating parties
with appropriate grouping by subject
matter; it will also announce the amount
of time allocated t-o each participant..
6. Accordingly, it is ordered. That
panel discussions will be held at Wash­
ington. . D.C,,. during a 3-day period
commencing March 27,1972. at a location
and cimes to be announced by subsequent
order, and that oral argument vnll be
held before the Commission “en banc"
at its offices in Washington, D.C*. begin­
ning on March 30 at 9:30 a,m. and con­
tinuing on the following day. Persons
desiring to participate in the oral argu­
ment shall file a notice of appearance m
accordance with the terms of this order
within 5 days of the date of release of
this order.
Adopted: March 2.1972,
ReUoaed: March 3,1972.

fSCAL]

Federal Communication's
Commission/
Dzs F. Wapls,

Secretary,
|FR Doc.72-3 199 Filed 3-7-72;S:5l zrz]
3 Commissioners Bartley p.nd H. Rex Lee
ftbient.

:C’sT:?, vat. 37. NO. 46__ V;jDn=S0AV, WAUCH 8, 1972

ASI-PR 0001494