Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 65

DECLARATION of Amy A. Barcelo in Support re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D (part 1 of 6), # 5 Exhibit D (part 2 of 6), # 6 Exhibit D (part 3 of 6), # 7 Exhibit D (part 4 of 6), # 8 Exhibit D (part 5 of 6), # 9 Exhibit D (part 6 of 6), # 10 Exhibit E (part 1 of 8), # 11 Exhibit E (part 2 of 8), # 12 Exhibit E (part 3 of 8), # 13 Exhibit E (part 4 of 8), # 14 Exhibit E (part 5 of 8), # 15 Exhibit E (part 6 of 8), # 16 Exhibit E (part 7 of 8), # 17 Exhibit E (part 8 of 8), # 18 Exhibit F, # 19 Exhibit G, # 20 Exhibit H, # 21 Exhibit I)(Barcelo, Amy)

Attorney General’s Manual
on the

Administrative Procedure Act.

Prepared by the

United States Department of Justice
TOM C. CLARK
Attorney General
’947

ATTORNEY GENERAL’S MANUAL

ADMINISTRATIVE PROCEDURE ACT

FUNDAMENTAL CONCEPTS
NOTE CONCERNING MANNER OF CITATION OF LEGISLATIVE MATERIAL

The legislative history of the Administrative Procedure Act
really begins with the Final Report of the Attorney General’s
Committee on Administrative Procedure (cited hereinafter as
Final Report). This Report led to the introduction in Congress
of the so-called majority and minority bills, respectively designated as S. 675 and S. 674, 77th Cong., 1st sess. These bills,
together with S. 918, formed the basis for the extensive and
valuable hearings held in 1941 before a subcommittee of the Senate
Committee on the Judiciary (cited hereinafter as Senate Hearings
(1941)). In 1945,the House Committee on the Judiciary held brief
hearings (cited hereinafter as House Hearings (1945)) on various
administrative procedure bills, of which H.R. 1203, 79th Cong., 1st
sess., was the precursor of the present Act. Also in June 1945, the
Senate Committee on the Judiciary issued a comparative print, with
comments,, which is an essential part of the legislative history.
The Committee reports on the Act are Sen. Rep. 752, 79th Cong.,
1st sess. (cited hereinafter as Sen. Rep.). and H.R. Rep. 1980,
79th Cong., 2nd sess. (cited hereinafter as H.R. Rep.). In October
1945, the Attorney General, at the request of the Senate Committee
on the Judiciary, submitted a letter, with memorandum attached,
setting forth the understanding of the Department of Justice
as to the purpose and meaning of the various provisions of the
bill (5. 7). This letter and memorandum constitute Appendix B
of the Senate Committee Report and have been printed as Appendix B to this manual.
There may be obtained from the Government Printing Office
Sen. Doe. No. 248, 79th Cong., 2nd sess., entitled "Administrative
Procedure ActLegislative History" (cited hereinafter as Sen.
Doc.), which contains the Senate and House debates on the
Administrative Procedure Act, together with all the documents
mentioned above, except the Final Report of the Attorney General’s
Committee on Administrative Procedure and the Senate Hearings
(1941). Wherever appropriate, there will be two citations, one
to the particular report or hearing in which the legislative material appears, the other a parenthetical reference to the corresponding page in the Senate Document.

a. Basic Purposes of the Administrative Procedure Act
The Administrative Procedure Act may be said to have four
basic purposes:
1. To require agencies to keep the public currently informed
of their organization, procedures and rules (sec. 3).
2. To provide for public participation in the rule making
process (sec. 4).
3. To prescribe uniform standards for the conduct of formal
rule making (sec. 4(b) and adjudicatory proceedings (sec. 5),
i.e., proceedings which are required by statute to be made on the
record after opportunity for an agency hearing (secs. 7 and 8).
4. To restate the law of judicial review (sec. 10).
b. Coverage of the Administrative Procedure Act
The Administrative Procedure Act applies, with certain exceptions to be discussed, to every agency and authority of the
Government. Section 2(a) of the Act reads, in part, as follows:
"Agency" means each authority (whether or not within or subject
to review by another agency) of the Government of the United States
other than Congress, the courts, or the governments of the possessions,
Territories, or the District of Columbia. Nothing in this Act shall be
construed to repeal delegations of authority as provided by law.

It will be seen from the above that agency is defined as
each authority of the Government of the United States, whether
or not within or subject to review by another agency. This
definition was adopted in recognition of the fact that the Government is divided not only into departments, commissions, and
offices, but that these agencies, in turn, are further subdivided into
constituent units which may have all the attributes of an agency
insofar as rule making and adjudication are concerned.’ For
example, the Federal Security Agency is composed of many
1 The legislative history of section 2(a) illustrates clearly the broad scope of toe term
"agency." In the Senate Comparative Print of June 1945, the term agency was
explained as follows (p. 2) : "It is necessary to define agency as ’authority’ rather than by
name or form, because of the present system of including one agency within another or of
authorizing internal boards or ’divisions’ to have final authority. ’Authority’ means any
officer or board, whether within another agency or not, which
by law has authority to take
final and binding action with or without appeal to some superior administrative authority.
Thus, ’divisions’ of the Interstate Commerce Commission and the judicial officers
of the Deartment of Agriculture would be ’agencies’ within this definition." (Sen.
131
. And in the Senate Report the following appears at page 10 "The word
Doe. p.
’authority’ is advisedly used as meaning whatever persons are vested with powers to act
(rather than the mere form of agency organization such as department, commission,
board, or bureau) because the real authorities may be some subordinate or semidependent
P.
person or persons within such form of organization." (Sen. Doc. p. 196). See also H.R.
Rep.
19 (Sen. Doc. p. 253).

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ATTORNEY GENERAL’S MANUAL

ADMINISTRATIVE PROCEDURE ACT

authorities which, while subject to the overall supervision of that
agency, are generally independent in the exercise of their functions. Thus, the Social Security Administration within the Federal
Security Agency is in complete charge of the Unemployment
Compensation provisions of the Social Security Act. By virtue
of the definition contained in section 2 (a) of the Administrative
Procedure Act, the Social Security Administration is an agency,
as is its parent organization, the Federal Security Agency.
The Administrative Procedure Act applies to every authority
of the Government of the United States other than Congress, the
courts, the governments of the possessions, Territories, and the
District of Columbia (sec. 2(a)). The term "courts" is not limited to constitutional courts, but includes the Tax Court, the Court
of Customs and Patent Appeals, the Court of Claims, and similar
courts. Sen. Rep. p. 38 (Sen. Doc. p. 408).
While the Administrative Procedure Act covers generally all
agencies of the United States, certain agencies and certain functions are specifically exempted from all the requirements of the
Act with the exception of the public information requirements
of section 3. Section 2(a) states, in part: "Except as to the
requirements of section 3, there shall be excluded from the operation of this Act (1) agencies composed of representatives of
the parties or of representatives of organizations of the parties
to the disputes determined by them, (2) courts martial and
military commissions, (3) military or naval authority exercised in the field in time of war or in occupied territory, or (4)
functions which by law expire on the termination of present
hostilities, within any fixed period thereafter, or before July 1,
1947, and the functions conferred by the following statutes:
Selective Training and Service Act of 1940; Contract Settlement
Act of 1944; Surplus Property Act of 1944; Sugar Control Extension Act of 1947; 2 Veterans’ Emergency Housing Act 3 of 1946
and the Housing and Rent Act of 1947."
It will be helpful to consider each of these exceptions separately:
(1) "agencies composed of representatives of the parties or
of representatives of organizations of the parties to the disputes
determined by them." This definition is intended to embrace such
agencies as the National Railroad Adjustment Board, composed

of representatives of employers and employees. In addition, it
includes agencies which have a tripartite composition in that
they are composed of representatives of industry, labor and the
public, such as the Railroad Retirement Board and special fact
finding boards. H.R. Rep. p. 19 (Sen. Doe. p. 253); 92 Cong. Rec.
2152, 5649 (Sen. Doe. pp. 307, 355). The exemption, it will be seen,
is not limited to boards which convene only occasionally, with per
diem compensation, to determine, arbitrate or mediate particular
disputes, but also includes similar boards or agencies composed
wholly or partly of full-time paid officers of the Federal Government.
(2) "courts martial and military commissions."
(3) "military or naval authority exercised in the field in time
of war or in occupied territory."
(4) "functions which by law expire on the termination of
present hostilities, within any fixed period thereafter, or before
July 1, 1947, and the functions conferred by the following statutes:
Selective Training and Service Act of 1940; Contract Settlement
Act of 1944; Surplus Property Act of 1944; Sugar Control Extension Act of 1947; Veterans’ Emergency Housing Act of 1946;
and the Housing and Rent Act of 1947." The functions thus exempted on the ground of their temporary nature may be classified,
as to their termination, as follows:
(a) "On the termination of present hostilities"A considerable number of statutes authorizing wartime programs and
controls limit the duration of these functions by such phrases as
"in time of war", "for the duration of the war", "upon cessation of
hostilities as proclaimed by the President", "upon the termination
of the unlimited national emergency proclaimed by the President
on May 27, 1941", etc. It is clear from the legislative history of
section 2(a) that the exemption is not to be limited to functions
derived from statutes which provide for expiration "on the
termination of present hostilities" sic, but rather extends to all
functions which are limited as to duration by phrases such as
those quoted above. House Hearings (1945) pp. 36-37 (Sen. Doe.
pp. 82-83); 92 Cong. Rec., 5649 (Sen. Doe. p. 355). It is also
clear that this exemption for temporary war functions is in
no way affected by the circumstance that they may be continued in existence for a considerable period of time after
combat operations have ceased. It is well established that statutes authorizing such temporary agencies and functions remain

2 This exception was added by Public Law 30, 80th Cong., 1st seas.
8 This exception was added by Public Laws 663 and 719, 79th Cong., 2d Bess.
4 This exception was added by Public Law 129, 80th Cong., 1,t sees.

11

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ATTORNEY GENERAL’S MANUAL

in effect until a formal state of peace is restored or some earlier
termination date is made effective by appropriate governmental
action. See Hamilton v. Kentucky Distilleries Co., 251 U. S. 146
(1919); and the Attorney General’s letter to the President, dated
September 1, 1945, in H.R. Doe. 282, 79th Cong., 1st sess., p. 49.
The conclusion that the exemption is not measured by the duration of actual combat operations is confirmed by the fact that
this Act, containing the exemption, did not become law until
June 11, 1946.
(b) "Within any fixed period thereafter (after the termination of present hostilities) "This phrase provides exemption for
functions which terminate, for example, "six months after the
termination of the unlimited national emergency proclaimed by
the President on May 27, 1941." It is unnecessary to repeat the
discussion under (a), supra, as the meaning of the phrase
"termination of present hostilities."
(c) "On or before July 1, 1947"This encompasses such
functions as expire on or before that date.
(d) The functions conferred by the Selective Training and
Service Act of 1940, the Contract Settlement Act of 1944, the
Surplus Property Act of 1944, the Veterans’ Emergency Housing
Act of 1946, the Sugar Control Extension Act of 1947 and the
Housing and Rent Act of 1947 are specifically exempted, regardless of their expiration date. Thus the War Assets Administration, insofar as its functions are derived from the Surplus
Property Act, is not subject to the provision of the Act, with the
exception of section 3.
The foregoing agencies and functions have been specifically
exempted from all the provisions of the Act with the exception of
section 3. This means, in effect, that the rule making provisions
of section 4, the adjudication provisions of section 5, and the
judicial review provisions of section 10 are not applicable to them.
These broad exceptions, accordingly, must be borne in mind
in connection with the discussion of the other sections of the Act.
Specific exceptions to various sections will be noted in the discussion of such sections.
c.Distinction Between Rule Making and Adjudication
The Administrative Procedure Act prescribes radically different procedures for rule making and adjudication. Accordingly,
the proper classification of agency proceedings as rule making or
adjudication is of fundamental importance.

ADMINISTRATIVE PROCEDURE ACT

13

"Rule" ’and "rule making", and "order" and "adjudication"
are defined in section 2 as follows:
(c) Rule and rule making. "Rule" means the whole or any part of
any agency statement of general or particular applicability and future
effect designed, to implement, interpret, or prescribe law or policy or to
describe the organization, procedure, or practice requirements of any
agency and includes the approval or prescription for the future of
rates, wages, corporate or financial structures or reorganizations
thereof, prices, facilities, appliances, services or allowances therefor or
of valuations, cost, or accounting, or practices bearing upon any of
the foregoing. "Rule making" means agency process for the formulation, amendment, or repeal of a rule.
(d) Order and adjudication. "Order" means the whole or any part
of the final disposition (whether affirmative, negative, injunctive, or
declaratory in form) of any agency in any matter other than rule
making but including licensing. "Adjudication" means agency process
for the formulation of an order.
(e) License and licensing. "License" includes the whole or part of
any agency permit, certificate, approval, registration, charter, membership, statutory exemption or other form of permission. "Licensing"
includes agency process respecting the grant, renewal, denial, revocation, suspension, annulment, withdrawal, limitation, amendment, modification, or conditioning of a license.

Since the definition of adjudication is largely a residual one,

i.e., "other than rule making but including licensing", it is logical
to determine first the scope of rule making. The definition of rule
is not limited to substantive rules, but embraces interpretative,
organizational and procedural rules as well. 5 Of particular importance is the fact that "rule" includes agency statements not only
of general applicability but also those of particular applicability
applying either to a class or to a single person. In either case,
they must be of future effect, implementing or prescribing future
law. Accordingly, the approval of a corporate reorganization by
the Securities and Exchange Commission, the prescription of
future rates for a single named utility by the Federal Power
Commission, and similar agency actions, although applicable only
to named persons, constitute rule making. H.R. Rep. p. 49, fn. 1
(Sen. Doc. p. 283).
As applied to the various proceedings of Federal agencies, the
definitions of "rule" and "rule making", and "order" and "adjudication" leave many questions as to whether particular proceedings are rule making or adjudication. For example, the question arises whether agency action on certain types of applications
is to be deemed rule making or licensing (adjudication), in view
of the fact that there is apparent overlapping between the defini5 Note that section 4 (apart from 4(d)) is applicable only to substantive rules,
I.e.,
rules issued pursuant to statutory authority to implement statutory policy, as by fixing
rates or defining standards.

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ATTORNEY GENERAL’S MANUAL

tion of "rule" in section 2(c) and of "license" in section 2(e).
Thus, "rule" includes the "approval * * * for the future * * s", and
"license" is defined to include "any agency permit, certificate,
approval * * * or other form of permission."
An obvious principle of construction is that agency proceedings
which fall within one of the specific categories of section 2(c), e.g.,
determining rates for the future, must be regarded as rule making,
rather than as coming under the general and residual definition
of adjudication. Furthermore, the listing of specific subjects in
section 2 (c) as rule making is not intended to be exclusive. It is
illustrative only. H.R. Rep. 20 (Sen. Doc. p. 254). Thus, in determining whether agency action on a particular type of application
is "rule making", the purposes of the statute involved and the
considerations which the agency is required to weigh in granting
or withholding its approval will be relevant; if the factors governing such approval are the same, for example, as the agency would
be required to apply in approving a recapitalization or reorganization (clearly rule making) , this circumstance would tend to support
the conclusion that agency action on such an application is rule
making.
More broadly, the entire Act is based upon a dichotomy between
rule making and adjudication. Examination of the legislative
history of the definitions and of the differences in the required
procedures for rule making and for adjudication discloses highly
practical concepts of rule making and adjudication. Rule making
is agency action which regulates the future conduct of either
groups of persons or a single person; it is essentially legislative
in nature, not only because it operates in the future but also because it is primarily concerned with policy considerations. The
object of the rule making proceeding is the implementation or
prescription of law or policy for the future, rather than the
evaluation of a respondent’s past conduct. Typically, the issues
relate not to the evidentiary facts, as to which the veracity and
demeanor of witnesses would often be important, but rather to
the policy-making conclusions to be drawn from the facts. Senate
Hearings (1941) pp. 657, 1298, 1451. Conversely, adjudication
is concerned with the determination of past and present rights
and liabilities. Normally, there is involved a decision as to whether
past conduct was unlawful, so that the proceeding is characterized
by an accusatory flavor and may result in disciplinary action.
Or, it may involve the determination of a person’s right to bene-

ADMINISTRATIVE PROCEDURE ACT

15

fits under existing law so that the issues relate to whether he is
within the established category of persons entitled to such benefits. In such proceedings, the issues of fact are often sharply
controverted. Sen. Rep. p. 39 (Sen. Doc. p. 225); 92 Cong. Rec.
5648 (Sen. Doe. p. 353).
Not only were the draftsmen and proponents of the bill
aware of this realistic distinction between rule making and adjudication, but they shaped the entire Act around it. Even in
formal rule making proceedings subject to sections 7 and 8, the
Act leaves the hearing officer entirely free to consult with any
other member of the agency’s staff. In fact, the intermediate
decision may be made by the agency itself or by a responsible
officer other than the hearing officer. This reflects the fact that
the purpose of the rule making proceeding is to determine policy.
Policy is not made in Federal agencies by individual hearing
examiners; rather it is formulated by the agency heads relying
heavily upon the the expert staffs which have been hired for that
purpose. And so the Act recognizes that in rule making the intermediate decisions will be more useful to the parties in advising
them of the real issues in the case if such decisions reflect the
views of the agency heads or of their responsible officers who assist
them in determining policy. In sharp contrast is the procedure
required in cases of adjudication subject to section 5(c). There
the hearing officer who presides at the hearing and observes the
witnesses must personally prepare the initial or recommended
decision required by section 8. Also, in such adjudicatory cases,
the agency officers who performed investigative or prosecuting
’functions in that or a factually related case may not participate
in the making of decisions. These requirements reflect the characteristics of adjudication discussed above.
The foregoing discussion indicates that the residual definition
of "adjudication" in section 2(d) was intended to include such
proceedings as the following:
1. Proceedings instituted by the Federal Trade Commission
and the National Labor Relations Board leading to the
issuance of orders to cease and desist from unfair methods
of competition or unfair labor practices, respectively.
2. The determination of claims for money, such as compensation claims under the Longshoremen’s and Harbor Workers’
Compensation Act, and claims under Title II (Old Age
and Survivors’ Insurance) of the Social Security Act.

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ATTORNEY GENERAL’S MANUAL

3. Reparation proceedings in which the agency determines
whether a shipper or other consumer is entitled to damages
arising out of the alleged past unreasonableness of rates.
4. The determination of individual claims for benefits, such
as grants-in-aid and subsidies.
5. Licensing proceedings, including the grant, denial, renewal,
revocation, suspension, etc. of, for example, radio broadcasting licenses, certificates of public convenience and
necessity, airman certificates, and the like.

ADMINISTRATIVE PROCEDURE ACT

17

II
SECTION 3-PUBLIC INFORMATION

The purpose of section 3 is to assist the public in dealing with
administrative agencies by requiring agencies to make their administrative materials available in precise and current form. Section
3 should be construed broadly in the light of this purpose so as
to make such material most useful to the public. The public
information requirements of section 3 do not supersede the
Federal Register Act (44 U.S.C. 301 et seq.). They are to be
integrated with the existing program for publication of material in the Federal Register and the Code of Federal Regulations.
The Federal Register Regulations (11 F.R. 9833) govern the
manner in which documents are to be prepared prior to submission to the Division of the Federal Register. All materials issued
under section 3(a) of the Act will be included in the Code of
Federal Regulations and should be prepared accordingly. The
Division of the Federal Register is prepared to offer assistance
to the agencies in this respect.
AGENCIES SUBJECT TO SECTION

3

This section, unlike the other provisions of the Act, is applicable to all agencies of the United States, excluding Congress, the
courts, and the governments of the Territories, possessions, and
the District of Columbia. Every agency, whether or not it has
rule making or adjudicating functions, must comply with this
section. Section 2 (a), defining agencies, states specifically that
even the exemption for the functions enumerated in the last
sentence of that section does not extend to section 3. Accordingly,
agencies performing temporary war functions must comply with
this section.
EXCEPTIONS TO REQUIREMENTS OF SECTION

3

Two exceptions have been made to section 3, namely:
"(1) Any function of the United States requiring secrecy in
the public interest." This would include the confidential operations of any agency, such as the confidential operations of the
Federal Bureau of Investigation and the Secret Service and, in
general, those aspects of any agency’s law enforcement procedures the disclosure of which would reduce the utility of such