A. NATIONAL SECRECY ACT

• Document Type: CREST
• Collection: General CIA Records
• Document Number (FOIA) /ESDN (CREST): CIA-RDP76M00527R000700080041-1
• Release Decision: RIPPUB
• Original Classification: K
• Document Page Count: 6
• Document Creation Date: December 19, 2016
• Document Release Date: July 20, 2006
• Sequence Number: 41
• Publication Date: April 2, 1973
• Content Type: OPEN

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April 2, 1973 CONGRESSIONAL RECORD - SENATE
said. "Higher productivity should not be the
goal, although it may follow."
The conference, now going at the New York
Hilton Hotel, is the second of three such
meetings sponsored by Urban Research Cor-
poration. These meetings reflect a rising ' in-
terest in the issue of worker alienation among
industry, Government and the academic
authority.
This interest has been awakened in the last
year by the rising incidence of such apparent
signs of worker dissatisfaction as absentee-
ism, inplant crime, drug abuse, vandalism,
declining productivity-or hourly output per
worker-and indications of rebellion against
traditional management authority.
However, a new survey presented at the
conference Sunday night by George Gallup,
Jr,. president of the American Institute of
Public Opinion, indicated, he said, "that
worker morale in the United States is not on
the verge of collapse-that the typical Amer-
ican in both white-collar and blue-collar jobs
is, by and large, content."
In the Gallup Poll of 1,520 adults con-
ducted in late January, 77 per cent responded
that they were satisfied with the work they
do and 48 per cent of the sample said they
were very satisfied. Only 11 per cent re-
sponded that they were dissatisfied and 12
per cent had no opinion.
But Mr. Gallup pointed out that the num-
ber of those satisfied with their work had
declined by 10 per cent since the same
question was asked in April, 1960. What is
more, he reported, young workers under 30
years of age were substantially more dis-
satified with their jobs than others in the
survey.
"AN ENTRENCHED SYSTEM"
Mr. Gallup asserted the results indicated
"a greater degree of discontent today then
we have found for a number of years-par-
ticularly among young persons. I think it Is
safe to say that young workers dissatisfied
with their jobs pose a growing threat to
United States industrial output."
Senator Percy placed much of the blame
for this dissatisfaction on "an entrenched,
authoritarian Industrial system that has
taken decades and decades to build."
"There is a strong feeling," he asserted,
"that management and labor institutions
have sometimes grown too rigid. Too often
they have become blind to the broader needs
of our society."
The Senator from Illinois contended that
new forces was changing every American in-
stitution, from marriage and the family to
schools and churches. But these changes, he
said, have stopped at the plant gate and "the
American workplace has stubbornly re-
mained virtually the last redoubt of yester-
day's values."
But experiments now going on, Mr. Percy
said, suggest that there already are tech-
niques available to solve the problems of
worker dissatisfaction.
Some of these programs and experiments
were described at the conference by experts
of the companies involved in them. They in-
cluded the Chase Manhattan Bank, Corning
Glass, Donnelly Mirrors, the General Motors
Corporation, the General Foods Corporation,
the General Electric Company and othrers.
Donnelly Mirrors, which makes automobile
mirrors, not only has divided its work force
into teams with decision-making powers, but
also .shares productivity gains and guarantees
that its workers will not be unemployed be-
/'77/
A_NATIONAL SECRECY ACT?
Mr. HART. Mr. President, last eve-
ping my distinguished colleague from
Maine, Senator MUSKIE, delivered a
ST which raises grave questions
ecent legislative proposal of the
administration. Buried deep within S.
1400, the revision of the criminal code,
are proposed new criminal code provi-
sions which, taken together, can only be
described as a "national secrecy act." I
commend Senator MUSKIE'S speech to
my colleagues and hope that the points
it raises will be carefully considered in
our deliberation over the criminal code
revision.
Mr. President, I ask unanimous con-
sent that Senator MusKIE's speech, a
background memorandum, and the rele-
vant provisions of S. 1400 be printed in
the RECORD.
There being no objection, the material
was ordered to be printed in the RECORD,
as follows:
REMARKS BY SENATOR EDMUND S. MUSKiE,
FROSTBURG STATE COLLEGE, FROSTBURG, MD.,
APRIL 1, 1973
This week in Vietnam America reached the
end of that famous tunnel where the light of
peace flickered for eight long years. This
week the last American troops flew out of
Vietnam and the last officially recorded
American prisoners of war were released to
freedom.
This week should have been a joyous and
a healing one. It should have signalled a new
period in American life, a new era of good
feelings such as the one that followed the
War of 1812, a new time of reconstruction
such as the one that should have followed
our own Civil War, a new and constructive
engagement with the tasks of restoring
unity and advancing the quality of Amer-
ican life.
It was at such a time when Abraham Lin-
coln, over a century ago, uttered these
words: "With malice toward none, with
charity for all, with firmness in the right as
God gives us to see the right, let us strive
on to finish the work we are in, to bind up
the nation's wounds, to care for him who
shall have borne the battle and for his
widow and his orphan, to do all which may
achieve and cherish a just and lasting peace
among ourselves and with all nations."
It is such a summons to greatness and
unity which Americans want to hear.
But what did they hear?
It was the week that an American official
in Saigon told a reporter: "The first thing
that needs to be said about the ceasefire is
that the firing hasn't ceased."
It was the week that an American Sec-
retary of Defense in Washington defended
the continued daily bombing by our B-52s
in Cambodia as necessary "to support our
ally there against the continuing efforts to
disrupt communications, to isolate Phnom
Penh."
It was the week that the President in the
White House vetoed legislation to provide
vocational rehabilitation to Americans who
are crippled, blind or otherwise disabled.
It was also the week when the President
asked the Nation to "put aside. those honest
differences about the war which have di-
vided us" and then sowed new division in
America by claiming for himself a monopoly
of wisdom about inflation, taxation and re-
sponsible government spending.
You can-say, perhaps, that it was a week
of politics as usual. I would say it was a
week of opportunities lost. And I regard that
loss as a bad omen, If we could not, in this
week of joy, begin, as Abraham Lincoln
wanted, "to bind up the Nation's wounds,"
when will we begin?
Nine years ago, Lyndon Johnson told the
Congress in his first state of the Union mes-
S 6329
mony through shared purpose, yet his efforts
fell short. The waste of war killed his hopes.
Now that the war is over, as far as Amer-
ica is concerned, we should be resuming the
search for harmony and be moving with new
energy and purpose against the poverty, ig-
norance and disease Lyndon Johnson identi-
fied as the common enemies of mankind.
But instead, I fear, we are tangled still in
angry and important disputes about presi-
dential and congressional power, about,
spending and taxation, about social needs
and governmental indifference, about the
whole structure of our Federal system and
about the integrity of our political process.
And to those disputes we must now add s
new one brought on by this administration's
latest attempt to stifle the flow of official in-
formation to the public. The attempt is hid-
den deep in a lengthy and complex legisla-
tive proposal introduced in the Congress this
week as a revision of the federal criminal
code. Five sections of that proposal, taken.
together, would establish in peacetime a sys-
tem of government censorship that's de-
mocracy could hardly tolerate in a time of
war.
The official secrets act being proposed
would punish government officials who dis-
closed almost any kind of defense and for-
eign policy information, whether or not its
disclosure would endanger national security.
It would punish newsmen who received
such information unless they promptly re-
ported the disclosure and returned the ma-
terial to a government official.
It would punish not only reporters but all
responsible officials of their publications or
broadcasting companies who participated In
making the unauthorized information
public.
It would punish government employees
who knew of a colleague's unauthorized dis-
closure and failed to report their co-worker's
action.
The law's penalties-from three to seven
years in jail, from $25,000 to $50,000 in
fines-would be imposed on actions which
are not now considered crimes, which are,
instead, the applauded work of investigative
journalists.
For instance, part of the law would make
any unauthorized disclosure of what is called
classified information a crime.
And the law would explicitly prevent offi-
cials who disclosed such information from
defending their action by proving that the
information was improperly classified.
Well, what is classified information? Ac-
cording to the administration proposal, it is
"any information, regardless of its origin,
which is marked or designated pursuant to
the provisions of a statute or executive or-
der or a regulation or rule thereunder, as in-
formation requiring a specific degree of pro-
tection against unauthorized disclosure for
reasons of national security."
On its surface, that, language sounds rea-
sonable, it does what existing law already
does by insuring secrecy of data about our
defense codes, about our electronic surveil-
lance techniques, about military installations
and weapons, about our atomic secrets and
about plans and operations which might aid
our enemies. All that information is already
kept secret by laws which punish its dis-
closure with intent to damage America and
its security.
But this new law would go farther. It
would prohibit and penalize disclosure of any
classified information, regardless of whether
or not it damaged security.
Classified information, you should know,
is any document or record or other material
which an
n
f
2
y o
e o
over
0,000 government of-
tween man.and society which will allow each ficials might have decided-for reasons they
of us to enlarge the meaning of his life and need never explain-should be kept secret?
all of us to elevate the quality of our civi- It is any piece of paper marked top secret,
lization." secret, or confidential, because someone,
President Johnson worked to create har- sometime, supposedly decided that its dis-
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 S 6330
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CONGRESSIONAL RECORD - SENATE April 2, 1973
closure could prejudice the defense interests
of the nation.
In practice, however, classified information
is material which some individual In the gov-
ernment decides he does not want made pub-
lic. He could make that decision to hide In-
competence. Many have.
He could be trying to conceal waste. Me ny
have.
He could even be -attempting to camouflage
corrupt behavior and improper influence.
Many have.
He could simply be covering up facts which
might embarrass him or his bosses. Ms.ny
have.
Classified information is the 20 million doc-
uments the pentagon's own most expori-
enced security officer has estimated to be in
defense department files. Classified inforria-
tion is the 26-year backlog of foreign policy
records in the state department archives.
And most of that information is Improperly
classified-notout of evil motives, but out of
a mistaken interpretation by conscientious
employees of what security actually requires.
They do not limit the use of secrecy stamps
just to information which would really af-
fect our national defense, if disclosed.
They often use them simply to keep mate-
rial out of the newspapers-to make it a li';tle
harder, perhaps, for a foreign nation to get
the information, whether the information is
defense-related or not.
Let me give you a few examples.
Around 1960, a sign in front of a mon cey
cage in the national zoo explained that the
monkey on display was a research animal
who had traveled into space in American
rockets. But at the same time the pentagon
was classifying all information that showed
we were using monkeys in space.
The reason given for trying to keep the
information secret was someone's concern
that it might damage our relationships v ith
India where some religious sects worship
monkeys.
Another example deals with India. Over a
year ago when India and Pakistan were at
war over the independence of Bangladesh,
the Nixon administration insisted in pu'Aic
that it was not interfering in the conflict,
that it was trying to be neutral. But Jack
Anderson revealed classified information
that proved that President Nixon had in-
structed Dr. Kissinger and others to "tilt"
toward Pakistan. That information was being
kept secret to conceal a lie.
India and Pakistan knew the truth. Cnly
Americans were being deceived.
Again, back before the Korean war, the
Navy Chief of Staff sent a memorandum. to
is colleagues complaining that too mach
raper was being circulated marked top secret.
His memo itself was marked top secret.
In 1970, the Rand Corporation produced
a document for the Defense Department
listing the unclassified electronic equipment
on U.S. aircraft. Nothing in the document
was secret or even drew on any secret data,
But the Air Force classified the listing as
confidential anyway.
Similarly, a laboratory at M.I.T. prepexed
an assembly manual last February for a
gyroscopic device used in missiles. Again
the Air Force classified the manual and put
the following words on Its front page: "f'ach
section of this volume is in itself uncleesi-
lied. To protect the compilation of inforna-
tion contained In the complete volume, the
complete volume is confidential."
And then in 1969 it was disclosed that
someone in the Navy Department was clip-
ping newspaper articles that contained facts
that were embarrassing to the Navy, pasting
those articles onto sheets of paper and stamp-
ing the paper secret. It turned out that such
a practice was common throughout the De-
tense Department.
If newspaper articles can be stamped
secret as a matter of course, what else is sys-
tematically beir..g hidden from the public?
Should this administration proposal become
law, you and I will never know the answer to
that question.
The examples I have given should indicate
to you the folly of any blanket prohibition
against the disclosure of classified informa-
tion, as long as our system of classification
is so erratic. arbitrary and unmanageable.
Not only would the proposed law per-
petuate the widespread abuses of secrecy I
have listed? it would enforce public ignorance
by making criminals out of honest men and
women who put the public interest above
bureaucratic secrecy. Indeed, the adminis-
tration's proposed secrecy law goes far beyond
protection of what might be legitimate
secrets as determined by a workable classi-
fication system, should one be developed.
Additionally, it would punish the unau-
thorized disclosure of "information relating
to the national defense ... regardless of its
origin" which relates, among other things,
to "the conduct of foreign relations affecting
the national defense." That broad definition
could bar intelligent- public scrutiny of
America's most significant foreign policy
decisions.
What could the enactment of such a
sweeping gag rc.le mean to the flow of infor-
mation to the public?
For one thing, the proposed law would
mean that Robert Kennedy, where he alive
and writing now, would risk prosecution for
publishing in his book, "Thirteen Days," the
secret cable Nikl.ta Krushchev sent the White
House during the- Cuba missile crisis of
October 1962.
It would mea:a that Seymour Hersh of the
New York Times could not write, as Tie did
last year, about the still-classified Peers
Report-the Army's own investigation of the
My Lai Massac;ce and the responsibility of
Army officers for concealing the facts of
that event.
It would mean that knowledgeable and
conscientious government employees could
be brought to ti ial for telling newsmen about
waste in defense contracts, or about fraud
in the management of the military P.X.
system.
It could mean denying the public the
information necessary to understand how
cost estimates an 47 weapons systems rose
by over $2 billion between March 21 and
June 30 last year.
Thus, the administration's official secrets
net would create staggering penalties for
disclosure of information even when the
information is totally misclassified or classi-
fied only to prevent public knowledge of
waste, error, dishonesty or corruption.
We already have the criminal sanctions we
need against disclosure of true defense
secrets. To expand the coverage of those pen-
alties can only stifle the flow of important
but not injurious information to the press,
and therefore, to, the public.
With the criminal penalties already in the
law and with the proven record of responsible
behavior by the great majority of government
employees and newsmen, the only purpose
behind further expansion of the secrecy laws
would be the effort tosilence dissent within
the governmen'; and hide incompetence and
misbehavior.
New penalities will not further deter
espionage and spying. They will only harm
those who want the public to know what the
government is doing.
Nothing could be better designed to restrict
the news you get to the pasteurized jargon
of official press releases than a law which
would punish it newsman for receiving sen-
sitive information unless he returned the
material promptly to an authorized official.
Nothing could damage the press more than
a provision which would make a newsman an
accomplice in crime unless he revealed the
source of information disclosed to him.
The administration proposal carries an
even greater danger in the power it would
give to the officials who now determine what
shall be secret and what shall be disclosed.
Not only would they be abel to continue to
make those decisions without regard to any
real injury disclosure might cause, they
would be empowered to prosecute anyone
who defied their judgment. Their Imposition
of secrecry could not be reviewed in the
courts. And a violation of their decision
would be a crime involving not only govern-
ment employees but journalists as well.
The Justice Department proposal goes far
beyond any laws we have had, even the
emergency requirements of World Was I and
II. No law now gives the government such
power to prosecute newsmen not only for re-
vealing what they determine the public
should know but just for possessing informa-
tion the government says they should not
have.
Under this proposal, a reporter who catches
the government in a lie, who uncovers fraud,
who unearths examples of monumental waste
could go to jail-even if he could show, be-
yond any question, that the government had
not right to keep the information secret and
that its release.could not possibly harm na-
tional defense.
This law then would force journalists to
rely on selfserving press releases manufac-
tured by timid bureagrats-or risk going to
jail for uncovering the truth.
It would force Government employees to
spy on each other in a manner familiar in
communist or fascist states but abhorrent
to our concept of an open democracy.
We have had enough of that abuse of se-
crecy in the attempts to hide the facts about
our conduct in Vietnam from the American
people. Official secrecy has even been used
to keep back vital facts about Government
meat inspection programs or pesticide regu-
lations or drug tests or import restrictions
or rulings that interpret income tax regu-
lations.
In a democracy there will always be a nec-
essary tension between the right of the peo-
ple to know and the requirement that Gov-
ernment officials be able to voice their opin-
ions with full candor. To assure that frank-
ness, confidential advice on grave questions
of policy should be protected from disclosure.
But in the balance between secrecy and dis-
closure, the public interest requires that the
greatest weight be given to informing and
Involving the people in policy decisions.
Arguments made in private may be per-
suasive. They may even be correct. But where
the public interest is at stake, argument
must be open so that it can be rebutted. To
be enforceable in a society built on trust,
decisions must be reached in a manner that
permits all those concerned to have equal
access to the decision makers.
So the greatest danger in the proposal is
the danger to America as a society built on
law and on trust. This law would weaken
the first amendment protections of free press
and free speech, but it would also further
isolate the American people from theinfor-
mation they must have to judge the conduct
of Government.
In an emergency situation, censorship can
be understandable and acceptable. But this
effort to inaugurate a constructive period of
peacetime cooperation by throttling dissent
and debate is unworthy and dangerous.
Unity in America can only be built out of
an informed consensus of all the people,
trusting in their leaders and trusting their
leaders to trust them. Extinguishing public
discussion of policy will not produce har-
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 April 2, 1973 CONGRESSIONAL RECORD - SENATE S 6331
mony. The silence. such a law would enforce
would be the silece of democracy's grave-
yard.
MEMORANDUM: THE NIXON ADMINISTRATION'S
PROPOSALS To RESTRICT PRESS ACCESS TO
GOVERNMENT CONFIDENTIAL SOURCES
On March 14, 1973, President Nixon sent
to Congress his message on the federal sys-
tem of criminal justice. in which he proposed
a sweeping reform of the Federal Criminal
Code in the "Criminal Code Reform Act of
1973;" the actual bill was sent to Congress on
Thursday, March 22, 1973 and introduced as
S. 1400 on Wednesday, March 28. This leg-
islation, which Is approximately 600 pages
long, contains some major revisions of the
Federal criminal code including the near
abolition of the insanity defense, an attempt
to revive the death penalty, and other con-
troversial changes in our present Federal
criminal laws.
Buried in this massive legislation, and un-
mentioned in the President's message about
it, lies four new sections to Title 18 which
would, if enacted, be the equivalent of a Na-
tional Secrecy Act. This memorandum dis-
cusses the scope of these proposed new fed-
eral crimes dealing with government se-
crecy, relates. them to the present controversy
regarding newspapermen's privilege, and
urges that you speak to this issue In the
immediate future.
1. THE PROPOSED NIXON. NATIONAL SECURITY ACT
a. Limitations on the Disclosure of
"Classified" Information
Two new sections of the proposed revised
criminal code deal with disclosure of classi-
fied information by government employees.
Section 1124 of the proposed code makes it
a felony for persons having authorized pos-
session or control of classified Information to
knowingly communicate such information to
unauthorized persons. Classified information
is broadly defined meaning "any informa-
tion, regardless of its origin, which is marked
or designated pursuant to the provisions of
a statute or executive order, or a regulation
or rule thereunder, as information requiring
a specific degree of protection against au-
thorized disclosure;" this means any infor-
mation classified not only under the appro-
priate executive order but under any agency
rule or regulation promulgated thereunder
is covered.
Section 1124(b) creates an exception to
criminal liability for accomplices or con-
spirators to such unauthorized disclosure if
they are persons receiving such classified
information. The ostensible purpose of Sub-
section (b) is to limit the offense to the il-
legal disclosure by the government employees
and to leave the reporter or other recipient of
the information without criminal liability.
However, as discussed below, this exception
has no meaning whatsoever since the re-
porter will commit a felony if he uses that
information in any way whatsoever or fails
to turn the information over to the govern-
ment. Indeed, its purpose may well be to
eliminate a Fifth Amendment defense when.
the government seeks from the reporter com-
pulsory disclosure of the source of the in-
formation which he obtained. This will also
be discussed below.
Section 1124(d) eliminates as a defense to
prosecution under this Section the fact that
the information divulged was improperly
classified either at the time of its classifica-
tion or at the time of its divulgence. The
penalty under this Section is imprisonment
of not more than three years and a fine of
not more than $25,000, unless the informa-
tion is communicated to an agent of foreign
powers.
A companion section is Section 1125 deal-
ing with unlawfully obtaining classified in-
formation. This Section makes it a felony
for a person "being an agent of a foreign
power". knowingly to obtain or collect classi-
fled Information which he is not authorized
to receive. This Section, to which there can
be little objection, clearly exempts reporters
from prosecution. The penalty for this felony
is not more than seven years imprisonment
and $50,000 fine.
These two Sections, on their face, appear
to limit the imposition of criminal penal-
ties to those within the government who vio-
late security classification regulations and
rules and give classified information, regard-
less of the reasonability of such classifica-
tion or regularity of the system under which
they were classified, to unauthorized persons.
These Sections appear to leave the reporters
free from criminal liability.
Such sweeping felony penalties for dis-
closure of information, even when the in-
formation is totally misclassified or classified
for the obvious reason of preventing dis-
closure of waste, mistakes, dishonesty or cor-
ruption, should be objected to. It can be con-
vincingly argued that present criminal sanc-
tions against unauthorized disclosure of
classified information are adequate, as ex-
perience has abundantly shown, and to In-
crease the penalties will only severely ham-
per the flow of information that should be
given to the press, and therefore, to the
public.
Both the persons who now have access to
this information and the press who could
publish it are both responsible enough to
avoid the public disclosure of information
that would be harmful to the real security
interests of the United States. There are few
-examples of a violation of these standards.
The self-censorship of the New York Times
and the Washington Post and other papers In
not publishing parts of the material revealed
in the Pentagon Papers is a good example of
this responsible behavior.
The relevant criminal statutes now in ef-
fect dealing with disclosure of classified in-
formation are as follows:
18 U.S.C. ? 952, forbidding government em-
ployees to publish or give to unauthorized
persons any diplomatic or military code or
any diplomatic or military material that
has been encoded.
18 U.S.C. ? 954, forbidding any person from
knowingly making untrue statements under
oath which that person has reason to be-
lieve will influence a foreign government and
thereby injure the United States.
18 U.S.C. ? 793, forbidding persons from
stealing documents, from making copies of
documents or photographs of military in-
stallations, equipment, or of photographs,
blueprints, plans, maps, or, models of such
military installations or material, and for-
bidding anyone from communicating infor-
mation relating to the national defense
"which information the possessor has reason
to believe could be to the injury of the
United States or the advantage of the for-
eign nation" and communicates such infor-
mation to any person not entitled to receive
it.
18 U.S.C. ? 794, forbidding people to gather
or deliver defense information with the in-
tent or reason to believe that is to be used
to the Injury of the United States or the ad-
vantage of a foreign government.
18 U.S.C. ? 798, forbidding persons from
knowingly and willTully communicating or
making available to an unauthorized person
any classified information which is related
to codes or cryptographic systems, their de-
sign, construction, use, maintenance, etc.
that may be used "in any manner prejudicial
to the safety or interest of the United States
or for the benefit of any foreign govern-
ment to the detriment of the United States."
All of these Sections, which are not re-
stricted to classified Information, are limited
in two ways: they deal with strictly mili-
tary related matters and/or they require an
intent to injure the United States or to aid
a foreign nation.
With the present criminal penalties and
responsibility of government employees and
reporters, the only purpose that the further
expansion of the secrecy laws could have is
to silence dissent within the government,
and to hide Incompetence and waste. New
penalties will not further deter espionage and
spying, they will only stop those who want
the public to know what is occurring in their
government.
b. The Limitations on Reporters' Use of
Unauthorized Classified Information
Although the two Sections of the proposed
new federal criminal code discussed above
appear to carefully carve out the'newsmen
from criminal liability for obtaining classi-
fled information, other carefully drawn sec-
tions of the criminal code make any use of
that material. by a reporter a felony. For ex-
ample, Section 1122 makes it a felony for any
person knowingly to communicate informa-
tion "relating to the national defense" to a
person not authorized to receive It. Thus,'any
reporter who Communicates such information
to anyone else i.e., gives it to his paper, tele-
vision station or causes it to be published
and transmitted to the general public has
committed a felony. "Information relating to
the national defense" is defined as informa-
tion, regardless of its origin, that relates to
U.S. military capabilities, planning, com-
munication, installation, weaponry, weapon
development or weapons research, to any in-
telligence activities of the United States, and-
to "the conduct of foreign relations affect-
ing the national defense." This sweeping
definition is ever broader than the definition
of classified information used In the two
Sections discussed above. A felony under Sec-
tion 1122 is punishable by imprisonment of
not more than seven years or a fine of not
more than $50,000.
If this deterrent to a reporter for using
unauthorized communications from govern-
ment sources were not enough, the proposed
revised criminal law contains another sec-
tion, Section 1123, which again makes it an
offense for a person being in possession or
control of information relating to national
defense to communicate it to a person not
authorized to receive it. (Section 1123(a)
(1)). The penalty is as in Section 1122.
Thus the proposed revision of the federal
criminal code makes it abundantly clear
that this proposed legislation intends to
make reporters directly criminally liable for
any use of information Obtained from the
federal government by confidential sources
when this information pertains to a very
broadly defined concept of national defense.
Attaching criminal penalties to the use of
information by the press is unprecedented
in American history except for the Alien and
Sedition Acts. In this case, the proposed
legislation is not only attempting to tighten
up the retention of this information within
its own bureaucracy, but is perfectly willing
to jail reporters up to seven years for pub-
lishing such information, even if that in-
formation was improperly classified, related
to abuses, dishonesty or waste in the federal
government, and it clearly served the na-
tional interest to make it public.
When these four provisions are taken to-
gether, they can only be described as a "na-
tional secrecy act," They impose severe crim-
inal penalties upon all unauthorized distri-
bution of information relating to national de-
fense and foreign relations. Any person in-
volved with such disseminaaion would be
liable, including the editors, publishers, and
distributors of newspapers. It would seem
that anyone who repeated the original pub-
lication would also be liable.
c. Methods To Force Disclosure Of the Source
Of Unauthorized Government Leaks
Of.course, for a national secrecy legislation
to be effective, not only must government
be able to prosecute the publishers and re-
porters involved in such dissemination of
unauthorized material but also, and more
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important, the political leaders of any gov-
ernment must be able to identify the sou.-oe
of such leaks promptly and eliminate them:
The legislation is not unmindful of this need
to identify the sources of unauthorized dis-
closures and has provided an effective mee.ns
for so doing within the statutory framework
of its "National Secrecy Act."
First, the Administration has proposed that
it be made a felony for a reporter to fail to
report that he has received unauthorized .re-
formation, even if he does not disclose that
information to anyone else. Section 1123' a)
(3) makes it a felony for an unauthorized
person in possession or control of informat on
relating to national defense to "knowin;ly
fail to deliver it promptly td'a federal public
service servant entitled to receive it." Thus,
if a reporter receives the information or. a
background basis and does not intend to
publish it, or he uses that information merely
to obtain confirmation from other le;al
sources, he is still committing a felony unless
he reports the illegal receipt of this informa-
tion to a government official. Thus all re-
porters not only commit a felony when they
use the information, but they commit a fel-
ony if they don't turn themselves in wt.en
they receive it.
In addition, Section 1123(a) (2) (B) mares
it a felony for a person in authorized posses-
sion or control of information relating to
national defense to "knowingly fail to re-
port promptly to the agency authorizing him
to possess or control such information ... .
communication to a person not authorized
to receive it." " Thus, anybody who leaks '.he
information or knows about a co-worker who
leaks the information has committed a felony
if he does not report such unauthorized dis-
closure. This Section makes each person in
the bureaucracy a spy of all his coworkers to
report any unauthorized disclosure of na-
tional security information by imposing, a
felony for failure to make such a report.
But most important for discovering :;he
source of the unauthorized leak is the power
that the- government would have if the "Ra-
tional Secrecy Act" were enacted to force
disclosure of the source by using the presont
state of the newspaperman's privilege. trn-
der the Branzburg v. Hayes (408 U.S. 1165
[19721) decision of last summer, newsmen
are not provided a constitutional protec-
tion for keeping their sources of information
confidential or for failing to reveal the con-
tents of the confidential information. Until
the enactment of any newspapermen's shield
legislation by the Congress, the only protec-
tion a reporter has from compulsory discIo-s-
ure of his sources are those few cases follow-
ing the Branzburg decision that try to sal-
vage some protection from dicta in that
decision and the guidelines set forth by the
Attorney General in 1970 which limit the fod-
oral use of compulsory testimony of reporters
to certain situations. It just so happens that
if the "National Secrecy Act" were enacted
in law, the dicta in the Branzburg decision
and the Attorney General's guidelines wo-ild
provide a reporter no defenses whatsoever
for a refusal to divulge his sources.
Under- the Branzburg decision, the - Coirt
clearly stated that of all the situations cull-
ing for possible constitutional protect: on
under the First Amendment for a newsmen's
privilege, the one case that merited no pro-
tection under any circumstances was the case
where a reporter was protecting the identity
of a person who actually committed a crime.
.Justice White, writing the majority decision,
said:
Although stealing documents or private
wiretapping could provide newsworthy in-
iormation, neither reporter nor source are
immune from conviction for such conduct,
whatever the impact on the flow of news.
(408 U.S. 665, at 691).
Insofar as any reporter in these cases un-
dertook not to reveal or testify about She
crime he witnessed, his claim of privilege
under the First Amendment presents no sub-
stantial question. (Id. at 692).
These two sentences in the majority
opinion of Branzburg make it almost impos-
sible for any lower court judge to hold that
a reporter's failure to divulge the source of
his information is privileged when disclosure
ofsuch information was a felony under the
"National Secrecy Act." The reporter who
received the information, although not a
conspirator or an accessory to the crime,
would clearly be a witness to it. His refusal
to testify would be, in no uncertain terms,
the refusal to identify a felon, and it is clear
that the Branzburg decision grants no priv-
ilege whatsoever to such a refusal.
The Attorney General's guidelines, which
claimed to limit and apparently have limited
the use by federal prosecutors of subpoenas
for reporters' sources of information and con-
fidential information would also clearly per-
mit the forced disclosure of such informa-
tion. Those guidelines require, in order to
issue a subpoena: that a serious crime had
been committed., that the Information not
be available from non-press sources, and that
the subpoena be strictly limited in time and
scope to the criminal action involved. Once
again, the reporter would have no protection.
He is a witness to a felony; in fact he prob-
ably is the only witness to the felony. A
serious crime is under investigation, a felony
Involving natfo:aal security. And the sub-
poena could clearly be limited in time or
scope to the communication that was in-
volved.
As Roger C. Crampton, Assistant Attorney
General, testified before the House Judiciary
Committee on September 21, 1972 about the
Attorney General's guidelines: "Compulsory
process is utilized only when information
necessary to determine the guilt of inno-
cence of persons under investigation for com-
mission of serious crimes can only be ob-
tained from the press."
Thus, once a reporter has printed informa-
tion that he obtained through unauthorized
disclosure, he will be subject to subpoena
and can be forced to reveal the sources of his
information because the fact of the Informa-
tion's very existence is prima facie evidence
of a felony having been committed in his
presence. In addition, by creating two dis-
tinct felonies, one for the disclosure of In-
formation (where the reporter is not liable),
and the other :'or the distribution of that
Information to any other party, it is quite
likely that the reporter will not have a
Fifth Amendment defense when he is sub-
poeneci, for his receipt of the information
itself was not c:iminal. The printing of the
information proves that the reporter pos-
sessed it, thus making the revelation of its
source ie no way increasing his jeopardy
of conviction of the felony of passing that
information on to others. With no Fifth
Amendment defense available, the reporter
would face the choice of going to jail for
contempt or revealing a source. Naturally,
the prosecuting attorney has the availability
of the other felony for bargaining purposes
with the reporter.
Thus, the prcposals constitute a compre-
hensive and effective "national secrecy act."
They create a felony for the unauthorized
disclosure of a broad category of informa-
tion, and the publication of such informa-
tion; It makes :.t a felony for a reporter to
retain that information or for co-employees
of the unauthorized source to fail to report
the unauthorized disclosure. And it utilizes
the present state of the law of compulsory
disclosure of newsmen's confidential sources
to ensure that the government could obtain
the identity of the sources of information
or Incarcerate tae reporters involved.
This situation makes the Administration's
refusal to support a newspaper shield law,
in either qualified or unqualified form, all
the more understandable.
RELEVANT PaovisioNs of S. 1400
'11122. Disclosing National Defense Infor-
mation.
"(a) Offense. A person is guilty of an of-
fense if he knowingly communicates infor-
mation relating to the national defense to a
person not authorized to receive it.
"(b) Grading. An offense described in this
section is:
"(1) a Class C felony if committed dur-
ing time of war or during a national defense
emergency;
"(2) a Class D felony in any other case.
1123. Mishandling National Defense Infor-
mation
"(a) Offense. A person is guilty of an of-
fense if:
"(1) being In possession or control of in-
formation relating to the national defense,
he recklessly permits its loss, destruction, or
theft, or communication to a person not au-
thorized to receive it;
"(2) being in authorized possession or con-
trol of information relating to the national
defense:
"(A) he intentionally fails to deliver it on
demand to a federal public servant author-
ized to demand it;
"(B) he knowingly fails to report promptly,
to the agency authorizing him to possess or
control such information, its loss, destruc-
tion, or theft, or communication to a person
not authorized to receive it; or
"(C) he recklessly violates a duty imposed
upon him by a statute or executive order,
or by a regulation or a rule of the agency au-
thorizing him to possess or control such in-
formation, which statute, order, regulation,
or rule is designed to safeguard such infor-
mation; or
"(3) being in possession or control of in-
formation relating to the national defense
which he is not authorized to possess or
retain, he knowingly fails to deliver it
promptly to a federal public servant entitled
to receive it.
"(b) Grading. An offense described in this
section is:
"(1) a Class E felony in the circumstances
set forth in subsection (a) (2) (0);
"(2) A Class D felony in any other case.
1124 Disclosing Classified Information
"(a) Offense. A person is guility of an of-
fense if, being or having been in authorized
possession or control of classified informa-
tion, or having obtained such Information as
a result of his being or having been a fed-
eral public servant, he knowingly communi-
cates such information to a person not au-
thorized to receive it.
"(b) Exceptions to Liability as an Accom-
plice or Conspirator. A personnot authorized
to receive classified information is not sub-
ject to prosecution as an accomplice within
the meaning of section 401 for an offense un-
der this section, and is not subject to pros-
ecution for conspiracy to commit an offense
under this section.
"(c) Defense. It is a defense to a pros-
ecution under this section that the infor-
mation was communicated only to a regu-
larly constituted committee of the Senate or
the House of Representatives of the United
States, or a joint committee thereof, pursuant
to lawful demand.
"(d) Defense Precluded. It is not a defense
to a prosecution under this section that the
classified information was improperly classi-
fied at the time of its classification or at the
time of the offense.
"(e) Grading. An offense described in this
section is:
" (1) a Class D felony if the person to whom
the information is communicated is an agent
of a foreign power;
"(2) a Class E felony In any other case.
1125. Unlawfully Obtaining Classified In-
formation.
"(a) Offense. A person is guilty of an of-
fense if, being an agent of a foreign power,
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he knowingly obtains or collects classified in-
formation which, in fact, he is not authorized
to receive.
"(b) Defense Precluded. It is not a defense
to a prosecution under this section that the
classified information was improperly clas-
sified at the time of its classification or at
the time of the offense.
"(c) Grading. An offense described in this
section is a Class D felony.
") 1126. Definitions for Section 1121 through
1125.
"(a) `authorized,' when used in relation to
the receipt, possession, or control of classi-
fied information or information relating to
the national defense, means with authority
to have access to, to receive, to possess, or to
control such information as a result of the
provisions of a statute or executive order, or
a regulation or rule thereunder;
"(b) `classified information' means any in-
formation, regardless of its origin, which is
marked or designated pursuant to the provi-
sions of a statute or executive order, or a
regulation or rule thereunder, as informa-
tion requiring a specific degree of protection
against unauthorized disclosure for reasons
of national security;
. "(c) 'communicate' means'to impart in-
formation, to transfer information, or other-
wise to make information available by any
means, to a person or to the general public,
" (d) `communications intelligence infor-
mation' means information:
"(1) regarding any procedures and methods
used by the United States.or any foreign
power in the interception of communications
and the obtaining of information from such
communications by other than the intended
recipients;
"(2) regarding the use, design, construc-
tion, maintenance or repair of a device or
apparatus used, or prepared or planned for
use, by the United States or a foreign power
in the interception of communications and
the obtaining of information from such
communications by other than the intended
recipients; or
"(3) obtained by use of the procedures or
methods described in paragraph (1), or by
a device or apparatus described in paragraph
.(2);
"(e) `cryptographic information' means
information:
"(1) regarding the nature, preparation,
use or interpretation of a code, cipher, cryp-
tographic system, or any other method of any
nature used for the purpose of disguising or
concealing the contents or significance or
means of communications, whether of the
United States or a foreign power;
"(2) regarding the use, design, construc-
tion, maintenance, repair of a device or ap-
paratus used, or prepared or planned for use,
for cryptographic purposes, by the United
States or a foreign power; or
"(3) obtained by interpreting an original
communication by the United States or a
foreign power which was in the form of a
code or cipher or which was transmitted by
means of a cryptographic system or any other
method of any nature used for the purpose
of disguising or concealing the contents or
significance or means of communications;
"(f) `information' includes- any property
from which information may be obtained;
"(g) `information relating to the national
defense' includes information, regardless of
its origin, relating to:
"(1) the military capability of the United
States or of an associate nation;
"(2) military planning or operations of
the United States;
"(3) military communications of the
United States;
"(4) military installations of the United
States;
"(5) military weaponry, weapons develop-
ment, or weapons research of the United
States;
"(6) restricted data as defined in section
11 of the Atomic Energy Act of 1954, as
amended (42 U.S.C. 2014) ;
"(7) intelligence of the United States, and
information relating to intelligence opera-
tions, activities, plans, estimates, analyses,
sources, and methods, of the United States;
"(8) communications intelligence infor-
mation or cryptographic information as de-
fined in subsection (d) or (e);
"(9) the conduct of foreign relations af-
fecting the national defense; or
"(10) in time of war, any other matter
Involving the security of the United States
which might be useful to the enemy;
"(h) 'restricted area' means any, area of
land, water, air or space which includes any
facility of the United States, or of a con-
tractor with or for the United States, to
which access is restricted pursuant to a
statute or executive order, or a regulation or
rule issued pursuant thereto, for reasons of
national defense.
THE VETO OF THE REHABILITATION
ACT
Mr. PERCY. Mr. President, I share the
President's resolve to put a ceiling on
spending and to hold a firm line on
prices, taxes, and inflation. However, I
am disappointed that the President has
again found it necessary to veto the Re-
habilitation Act of 1972, approved so
overwhelmingly by the Senate and the
House in both 1972 and 1973.
The Rehabilitation Act of 1972 Is not
a big spending bill that would jeopardize
the taxpayers' pocketbooks or the stabil-
ity of our economy. This bill, though ad-
mittedly more than the President re-
quested, provides $900,000 less in au-
thorization than last year's vetoed bill, a
reduction of over 25 precent.
This bill should not be looked upon as
a big spending measure. I would go as
far as to say that it is prime investment
material. For many of our physically and
mentally handicapped citizens, the only
alternative to rehabilitation is custodial
care under public assitance, which is
often costlier than rehabilitation. In 1972
alone, State vocational rehabilitation
agencies served 51,084 public assistance
recipients. It is estimated that the pub-
lic assistance cost for those individuals
would have amounted to $34,275,000 just
for the first year following rehabilitation.
Vocational rehabilitation is a proven
cost-effective program. A number of
cost-benefit analyses of the rehabilita-
tion program have agreed on one crucial
fact-the benefits of the rehabilitation
program are many times its cost. Con-
servative estimates of the ratio of bene-
fits to cost have ranged from between
8 to 1 and 35 to 1. In other words, for
every dollar spent on rehabilitation, $8
to $35 have been returned in welfare
costs saved and income taxes paid by
workers restored to usefulness.
For example, the total annual earn-
ings of 291,272 individuals rehabilitated
in 1971 totaled approximately $1 billion,
a net increase of $750,000 over the earn-
ings of these people before rehabilita-
tion. In addition to this contribution to
the GNP, the Rehabilitation Services
Administration estimates that these in-
dividuals, at a minimum, contributed
approximately 5 percent of their total
income of $58 million to Federal, State,
S 6333
and local governments for taxes. In ad-
dition to this tax contribution, there are
further Government savings because of
the removal of these persons from wel-
fare dependency.
The Illinois Vocational Rehabilitation
Agency, I am very proud to say, is a
successful example of the cost effective-
ness of rehabilitation. In fiscal 1971, the
agency served some 55,288 individuals,
and 14,001 of them were completely re-
habilitated. The total annual earnings of
these people in 1971 totaled approxi-
mately $47.2 million, showing a net in-
crease of $30 million over their earnings
before rehabilitation. If these reha-
bilitated wage earners contribute 5 per-
cent of their total income to Federal;
State, and local governments, their tax
contribution for 1 year alone would equal
2.4 million.
In fiscal 1972, the agency served some
58,922 people and completely rehabil-
itated 314 more persons than in 1971.
Of the 14,315 individuals completely re-
habilitated, 11 percent or 1,581, were
public assistance recipients. Of this to-
tal, 741 were removed entirely from the
public aid rolls, saving the State ap-
proximately $1.2 million in 1 year alone.
Coincidentally, it cost the agency about
$1.2 million to rehabilitate these people.
Moreover, 1,096 of these rehabilitated
individuals increased their earning power
by $3.9 million per year.
Today, developments in medical
science and technology have made
rehabilitation cost effective even for the
severely handicapped. Therefore, I
applaud the major change in the con-
cept of rehabilitation services under the
Rehabilitation Act of 1972-the added
emphasis on vocational rehabilitation
services to the' severely handicapped.
Until now the severely handicapped in
this country have been doomed to a
kind of living death, immobilized, hid-
den away, and written off as beyond re-
demption. This shortsightedness, in
addition to the cost in human agony
and waste, has cost society a huge
maintenance bill. Liberty Mutual esti-
mates that the lifetime cost of main-
taining one paraplegic is $150,000; and
the cost jumps to $250,000 to $500,000
for a quadriplegic. HEW estimates
that there are 985,000 Americans who
suffer from , paralysis. Without reha-
bilitation services, the lifetime main-
tenance cost for these individuals can
amount to $246 billion.
I am convinced that money spent on
the rehabilitation of our physically and
mentally handicapped citizens is a
sound investment, not only in making
life more livable for our handicapped
citizens but also in returning dollars to
the Federal, State, and local treasuries.
Vocational rehabilitation makes good
business sense. For this reason I must
regretfully vote to override the Presi-
dent's veto of the Rehabilitation Act of
.1972. We should find other areas where
budget cuts can be made. I intend to
sustain certain of the Presidents vetoes
and to vote against other spending bills
in the authorization or appropriation
stage before they are ever sent to the
President.
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April 2, 1973
--~ - CDNGRESSIONAL RECORD -SENATE
But I cannot walk away from my com-
mitment to the important area voca-
tional rehabilitation for the physically
or mentally handicapped. It is one )f
the best investments, we as a society,
can make in one human resources.
MANUFACTURING PRACTICES IN
THE DRUG INDUSTRY
rfr. RIBICOFF. Mr. President, the
GAO has released a report which stags
that the FDA has failed to exercise its
statutory mandate to assure that drugs
are processed under proper manufactur-
ing practices. GAO found that 48 per-
cent of the drug producers studied were
found to be deviating from good manu-
facturing practices on successive inspec-
tions by the FDA. In one plant, 78 da-
viations were found in three inspectiors,
of which 39 were deemed "critical." :n
spite of this appalling record, FDA failed
to take legal action to insure that the re-
quirements of law were met.
Drugs manufactured improperly may
cause severe health hazards. Examples
of the dangers of improperly manufa c-
tured drugs include the so-called Cutter
incident in which improperly manufa,,-
tured polio vaccines caused the paralyL is
of hundreds of people and the Abbot
Laboratory case in which hundreds of
people died as a result of receiving con-
taminated intravenous solutions.
The failure of FDA to enforce a law de-
signed to protect consumers in unforti-
nately all too typical of our experience
with Federal regulatory agencies. Tin e
and again, Congress has passed laws to
protect consumers, only to find that inad-
equate enforcement of those laws renders
them useless. I have introduced legisla-
tion to establish within the Federal Gov-
ernment a strong and effective consumer
advocate to assure that regulatory agea-
cies enforce the laws Congress has ea-
acted. The existence of such an advocate
could help preclude the continuance of
ineffective regulation.
I ask unanimous consent that a digest
of the GAO report be inserted in the
RECORD.
There being no objection, the digest
was ordered to be ,printed in the RECORD,
as follows:
PROBLEMS IN OBTAINING AND ENFORCING COM-
PLIANCE WITH GOOD MANUFACTURING PRI[C-
TICES FOR DRUGS
WHY THE REVIEW WAS MADE
Drugs sold In the United States during
recent years have been produced by about
6,400 firms. Although each is accountable tor
the quality of its products, the Congr:ss
placed upon the Food and Drug Administ:'a-
tion (FDA) the responsibility that drugs,
shipped across State borders, be of satis-
factory quality when sold to consumers.
The Federal Food, Drug, and Cosmetic Act
(FD&C Act) makes FDA responsible for in-
suring that adulterated drugs are prevented
from reaching the market. This law defi:ies
an adulterated drug as one, among ot:ier
things, which has not been produced in c(m-
formity with good manufacturing practices,
and requires FDA to inspect drug manu-
facturers and repackers (referred to here-
inafter as drug producers) at least once
every 2 years.
Good manufacturing practices include ',l)
maintaining formula and batch-production
control records and procedures, (2) estab-
lishing test procedures to insure that drug
components or the finished product conform
to appropriate standards of identity, strength,
quality, and purity, and (3) keeping distri-
bution records or each batch of a drug to
facilitate Its recall from distribution, if
necessary.
In this review the General Accounting
Office (GAO) has evaluated FDA's program
for inspecting drag producers and enfo'Sing
compliance with good manufacturing prac-
tices. GAO reviewed the inspection records of
73 drug producers inspected during the 2-
year period ended March 31, 1971, and the
Inspection records of 98 drug producers
which were not Inspected during this period.
Except for five Learge drug producers, firms
were randomly selected for review. The drug
producers were in three FDA districts in
which nearly 25 percent of the Nation's 6,400
drug producers were located.
FINDINGS AND CONCLUSIONS
Overall findings
Several factors have hindered FDA's ob-
taining and insuring compliance with good
manufacturing practices by drug producers.
FDA has not always enforced aggressively
compliance with good manufacturing prac-
tices by many of the drug producers it has
inspected, even though deviations from these
practices can lead to adulterated products.
Proper and timely written notification of
needed corrections was not provided to drug
producers' top management; and blowup
inspections were usually untimely,hamper-
ing, in many instances, FDA's efforts to ob-
tain voluntary compliance with good manu-
facLuring practices.
Some drug producers have not been in-
spected as often as required, although FDA
considers its inspection to be an integral part
of its defense against adulterated products
reaching the consumer.
FDA did not have a complete and accurate
list of drug producers required to be regis-
tered and inspected.
FDA has taken some steps to overcome
these problems. More are needed.
According to FDA, two factors have con-
tributed to existing conditions: (1) Its lim-
ited resources and (2) its need to be con-
cerned with good manufacturing practices
for drugs posing the most significant poten-
tial health hazard.
Limited enforcement
FDA inspections have shown a large num-
ber of producers to be deviating from good
manufacturing practices. Although such de-
viations can lead to adulterated drugs, FDA
has not enforced compliance with good
manufacturing practices by many of the
drug producers it has inspected.
During fiscal year 1971, FDA made 7,124
Inspections of drug producers. Of these,
nearly 4,000 were followup inspections where
deviations from good manufacturing prac-
tices had been reported previously. Over
2,174, showed that producers still were not
complying with good manufacturing prac-
tices.
In reviewing inspection records of 73 drug
producers, GAO found that 48 percent of the
producers critically deviated from good man-
ufacturing practices on successive Il:spec-
tions. FDA identifies critical deviations as
those having the greatest probability of cre-
ating adulterated products.
FDA has taken relatively few legal actions
to enforce compliance. During fiscal years
1970 and 1971, FDA approved only 51 seiz-
ures, 2 injunctions, and 5 prosecutions for
deviating from good manufacturing prac-
tices.
GAO believes that producers chronically
deviating from good manufacturing prac-
tices do not have sufficient incentive to cor-
rect their practices because FDA has not
used available legal options.
For example, FDA inspected one firm's
manufacturing practices three times during
the 32-month period ended December 15,
1971, concluding each time that the firm
was not complying with good manufac-
turing practices such as formula and pro-
duction control records not being main-
tained.
The number of deviations increased from
6 in the first inspection, to 23 in the second,
to 49 in the third inspection. Although 78
deviations were found, of which 39 were
critical, legal action was not taken. Instead,
FDA relied primarily on oral and written
communications with the firm and followup
Inspections to promote voluntary corrective
actions.
The shortcomings in FDA's enforcement
are believed to stem primarily from a lack of
instructions 'on when -egal actions should
be taken and the resultant confusion be-
tween district office personnel responsible
for recommending legal action and FDA
headquarters personnel responsible for ap-
proving it.
A February 1972 policy change indicates
FDA's intention to enforce good ma.n.ufactur-
ing practices more aggressively. GAO believes
that the continuing lack of guidelines to the
district offices will hamper the effectiveness
of this change.
Followup actions inadequate
Some drug producers have not corrected
deviations from good manufacturing prac-
tices because FDA frequently did not take
proper followup actions to insure that drug
producers' top management was aware of in-
spection findings.
GAO's examination of reports and other
records relating to 150 inspections of 58
producers included in the sample showed that
FDA issued a post inspection letter to top
management in only 75 of 150 inspections
made and that such letters were often un-
timely.
FDA lacked guidelines for timely Schedul-
ing of follow-up inspections to determine
whether producers take needed corrective
action. GAO reviewed-83 inspection cases in-
volving deviations from good manufacturing
practices for which followup inspections were
scheduled to be made during a specific month
prior to December 31, 1971. GAO found that
only 25 were made when scheduled, 32 were
made late, and 26 were not made by Decem-
ber 31, 1971. The timing of followup inspec-
tions is left to the discretion of each FDA
district office.
The February 1972 policy change discon-
tinued the use of post inspection letters as
a means of notifying drug producers of in-
spection findings. Instead, warning letters
will be used for minor deviations. Action to
seize products or cite firms for prosecution
will be used for critical deviations. Subse-
quent to the completion of GAO's fieldwork
FDA rescinded its policy statement of Febru-
ary 1972 and issued a new policy statement.
However, the policy change does not pro-
vide guidelines to insure that drug produc-
ers' replies to warning letters or citations will
be properly monitored and that timely fol-
lowup inspections will be made when needed.
Warning letters-unlike post inspection
letters and citations-do not specify a time
limit in which a drug producer must notify
FDA of corrective actions planned or taken.
Inspection coverage
FDA lacks an effective means of insuring
that all drug producers are inspected at least
once every 2 years as required by law. In the
three FDA districts reviewed, at least 213
drug producers, or about 16 percent, had
not been inspected during the 2-year period
April 1969 through March 1971. Another 123
firms were listed as not inspected but rec-
ords were not available to substantiate that
the firms were in fact subject to inspection.
Records of 98 of the 213 firms not in-
spected showed that an average of 36
months had elapsed (as of March 31, 1971)
since 74 of these firms were last inspected.
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