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Regulatory Reform Issue [1981] (4)
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Regulatory Reform Issue [1981] (4)
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STATEMENT
OF
Regulatory
Relief
JAMES C. MILLER III
ADMINISTRATOR FOR INFORMATION AND REGULATORY AFFAIRS,
OFFICE OF MANAGEMENT AND BUDGET
AND
EXECUTIVE DIRECTOR,
PRESIDENTIAL TASK FORCE ON REGULATORY RELIEF
BEFORE THE
COMMITTEE ON GOVERNMENTAL AFFAIRS
OF THE
U.S. SENATE
(May 12, 1981)
Mr. Chairman and Members of the Committee:
I am pleased to appear before you this morning to discuss long-needed
changes in the regulatory process. Joining me today is C. Boyden Gray,
Counsel to the Presidential Task Force on Regulatory Relief.
In recent years this Committee has made substantial progress in identifying
major problems of regulatory procedure and ways of dealing with them. We
have had a cordial working relationship with you and your staff and look
forward to a continuation of this relationship in the future.
Before addressing the merits of the major bills before the Committee, I
would like to emphasize the importance of the President's program of
regulatory relief and discuss our early experience under Executive Order
12291, "Federal Regulation."
2
President's Program of Regulatory Relief
President Reagan has made regulatory relief one of the four cornerstones of
his program of economic recovery. The first is budgetary restraint, the
second is tax reduction, the third is regulatory relief, and the fourth is a
stable monetary policy. All of these share the fundamental philosophical
underpinning of increasing aggregate economic activity SO as to increase
employment opportunities, reduce inflation, and raise the real incomes of
all Americans.
Budgetary reductions are a means of putting more resources in the private
sector, where they are more productive. Reductions in tax rates reduce the
disincentives for consumers to save and for businesses to invest.
Regulatory relief, of the type that leads to achieving regulatory goals at
lower costs, increases the supply of goods and services available for
satisfying other pressing needs. And a stable monetary policy reduces
uncertainty and therefore leads to greater investment on the part of
businesses and more thoughtful and rational expenditures on the part of
consumers.
As I have already stated, the President has given regulatory relief an
extraordinarily high priority since coming into office. The day after the
Inauguration he asked the Vice President to chair a Cabinet-level Task Force
3
on Regulatory Relief, which has been charged with reviewing new regulations,
assessing existing regulations, and coordinating the Administration's
legislative policies in the regulatory area. As the Vice President has
indicated, the charge given his Task Force is not to study regulation or
study ways of reforming regulation, but to provide regulatory relief.
I think we have made significant progress under the President's program.
Aided by Executive Order 12291, which I will describe in more detail in a
moment, we have moved forward to address many of the more pressing problems.
Almost every agency has been involved. Most notably, the Department of
Energy has moved expeditiously in removing restraints on energy production
and distribution. The Department of Labor-including the Occupational
Safety and Health Administration--has responded to acute needs to find ways
of achieving health and safety goals at lower costs. The Environmental
Protection Agency has taken important initiatives to streamline its
regulatory procedures and grant relief amounting to considerable savings at
little or no harm to the environment. The Department of Transportation
likewise has identified numerous regulations-especially those affecting the
automobile--which demand prompt attention.
Although we do not yet have final figures, I can assure you that the relief
measures identified thus far amount to billions of dollars per year.
Moreover, what has taken place to date is only the tip of the iceberg. Much
more will be forthcoming. Vice President Bush, Director Stockman,
4
Chairman Weidenbaum, and other Members of the Task Force have made it plain
to us that their expectations for regulatory relief are very high. The
President wants it, and the country demands it.
Experience under Executive Order 12291
Now, let me turn to the Administration's experience under the new Executive
Order. First, I think it is important to bear in mind that Executive Order
12291 has been in place only since February 17, and therefore experience has
been too short and insufficient to permit a definitive judgment as to
precisely how it will work in the long run.
The Executive Order has three major parts. First, it sets forth the
President's regulatory principles. These include requirements that if the
agency wishes to regulate, it should do SO for good reason; the benefits of
the regulation should exceed the costs; the agency should choose the least
costly way of securing the regulatory objective; and the regulation should
maximize net benefits.
5
Second, the Executive Order establishes the pre-eminence of the Presidential
Task Force on Regulatory Relief in matters concerning regulatory policy.
Third, the Executive Order creates a mechanism through which the Office of
Management and Budget (OMB), under the overall direction of the Task Force,
is to review proposed regulations and consult with agencies about them. It
also calls for a mechanism for OMB to identify existing regulations which
agencies must address, and for OMB and the Task Force to coordinate the
development of legislative proposals in the regulatory area. Consistent
with the responsibilities of my office under the Paperwork Reduction Act of
1980, we have endeavored to combine the processing of regulatory proposals
as to their paperwork requirements and the substance of the regulations.
Accordingly, we have developed a computerized system to monitor all
regulations that are forwarded by Executive Branch agencies.
6
Numerous regulatory agencies-independent as well as those in the Executive
Branch--have submitted rules for review under the order as shown below:
Department/Agency
Submissions
Agriculture
101
Commerce
38
Community Services Administration
1
Education
34
Energy
17
Environmental Protection Agency
161
Federal Emergency Management Agency
5
Federal Inspector for Alaska Natural
Gas Transportation
4
General Services Administration
13
Health and Human Services
15
Housing and Urban Development
37
Interior
22
Justice
15
Labor
31
National Foundation on the Humanities
5
Nuclear Regulatory Commission
1
Office of Personnel Management
10
Small Business Administration
2
State
2
Transportation
110
Treasury
1
U.S. Metric Board
3
Veterans Administration
30
TOTAL
658
7
One tangible result of our efforts has been to reduce significantly the flow
of new regulations from the Executive Branch agencies. As shown in the
table below, the rate of issuance of new regulations-both final and
proposed--is down by more than a third since January, and the number of
pages printed in the Federal Register has been cut by more than half.
Federal Register
Average Daily Number (1981)
Percent Change
Jan.
Feb.
Mar.
Apr.
April VS. Jan.
Final Rules
38
21
21
23
-39
Proposed Rules
25
14
11
16
-36
Pages Printed
461
230
231
214
-54
I want to stress, however, two points with regard to our experience under
the Executive Order. First, although I have been a close student of this
matter since having a responsibility for President Ford's Inflation Impact
Statement Program, I continue to be amazed at the variety of issues that
crop up from time to time. Thus, it is my firm belief that institutional
arrangements for addressing such issues must remain flexible. No one can
know in advance all the contingencies and be able to establish hard and fast
rules for dealing with them.
Second, I am daily thankful for the authority contained in the Executive
Order to exempt regulations. For example, we discovered quickly that a
morass of detailed minor regulations would quickly clog our regulatory
8
review pipeline. The authority granted by the Executive Order allowed us to
exempt certain classes of Internal Revenue Service, Environmental Protection
Agency, and Department of Transportation regulations that threatened to
bring our program to a standstill. On the other hand, our ability under the
Executive Order to identify certain regulations as "major" keeps the
agencies on their toes and enables us to take a close look at particularly
controversial or burdensome regulations that normally would not qualify as
"major."
Comments on S.1080 and S.344
Mr. Chairman and Members of the Committee, we in the Administration heartily
support the basic outlines of S.1080, the proposed Regulatory Reform Act,
and look forward to expeditious treatment of the bill by Congress. We wish
to emphasize, however, that the business of procedural reform is a two-edged
sword. Like SO many things in life, a good idea pushed to extremes can be
counterproductive, just as bad ideas always are. We want to work with you
to ensure that in any resultant legislation the appropriate balance is
struck between strengthened procedures and the necessary flexibility to
implement them. I believe that by and large S.1080 strikes the appropriate
balance.
We do have certain concerns with the language of S.1080, concerns we believe
should be addressed in the legislative process.
9
Two generic points especially concern us. First, we want to make very
certain that the bill would not restrain the Administration's ability to
achieve regulatory relief under the Executive Order. We believe that a
clear enunciation of the President's regulatory principles and the oversight
role of OMB and the Task Force are crucial to the success of this effort.
Second, we note that a significant difference between the review process
under Executive Order 12291 and the process that would be established by
S.1080 is the role of the judiciary in achieving the purposes of the
program. Under the Executive Order, there is no judicial enforcement of
the additional requirements imposed upon the agencies. In other words,
there can be no judicial challenges to agency rules on the grounds that a
rule should or should not have been a major rule that the Regulatory Impact
Analyses and reviews were inadequate, or that any other requirements of the
Executive Order had not been satisfied. The Executive Order relies upon the
Executive to enforce compliance with the Order, and I can assure you that we
will continue to do this aggressively. It may be appropriate at some point
to involve the courts in ensuring compliance with new regulatory procedures,
but we must ensure that we do not create a new gauntlet of judicially
reviewable procedures which could be used for purposes other than those for
which regulatory reform is intended.
10
With just a few changes, we believe the bill before you would satisfy these
concerns. Essentially, what is required is an Executive Branch oversight
mechanism that permits the White House greater enforcement over major rule
designations and compliance with the bill and that concommitantly reduces
the courts' role in these areas. We also believe that it would be simpler
to put the new procedural provisions in a new Chapter 6 of the
Administrative Procedure Act, rather than run the risk of unintentionally
complicating the well-understood provisions of existing Chapter 5.
With these and other minor changes, we believe that the basic provisions of
the bill would result in worthwhile, long-lasting reform of the regulatory
process. As our Executive Order indicates, we believe that it is essential
to do benefit-cost analysis where appropriate and to insist on the most
cost-effective means of achieving a statutory goal. Moreover, we believe it
equally important to provide a mechanism for the review of existing rules.
While we can achieve these same ends under the Executive Order, it would be
useful to perpetuate these principles-many of which, we should add, were
identified by this and other Committees during the last two years.
11
Similarly, it is important to require agencies to reveal at the outset of a
proceeding precisely what data and studies they are relying upon, SO that
all interested parties may be able to participate more fully. Fuller
participation is also insured by other provisions which prohibit final
agency reliance on material not available for comment. These are important
provisions and we support them.
The bill also contains a hearing and notification for major rules that have
come to be called hybrid rulemaking. We agree with the bills sponsors that
hybrid procedures would improve the regulatory process by strengthening the
factual basis for rules, SO long as the provision for judicial review is
carefully circumscribed to avoid dilatory litigation over purely procedural
issues. With minor technical changes, we believe S.1080 could accomplish
that objective.
In connection with judicial review, we should add one point about the
Bumpers Amendment. We see no serious problem in eliminating any presumption
of validity with respect to an agency's assertion of power or jurisdiction
beyond its statutory authorization. Indeed, under the Executive Order we
shall endeavor to accomplish this same objective. But other presumptions
not involving agency jurisdiction or power-such as those relating to
procedural regularity, statutory interpretation of technical or scientific
provisions, and an agency's own rules-serve a useful purpose in focusing
judicial review on the issues of significance. Moreover, elimination of
those presumtions would undo nearly half a century of precedent and create
needless uncertainties and litigation.
12
Now let me comment briefly on S.344. This bill contains a mechanism which
would allow individual committees of Congress to delay the effective dates
of a "significant" regulations for 60 days or more. While the
Administration supports increased Congressional oversight of regulatory
agencies, it has serious constitutional concerns with respect to legislative
veto devices and opposes any legislative veto that applies to Executive
Branch agencies. It is not my role to discuss the constitutional or legal
objections to such devices. I can say, however, that as a matter of policy
the Administration could accept certain versions of a legislative veto
mechanism applying only to selected "independent" agencies.
Finally, we would like to note that neither procedural legislation nor
legislative veto is a substitute for reform of substantive statutes like the
Clean Air Act. Passage of S.1080 would improve the regulatory process. But
the organic statutes must be reexamined and we would welcome consideration
of legislation that would provide for the periodic and comprehensive review
of existing legislated regulatory programs.
Mr. Chairman, Members of the Committee: that completes my prepared
statement. Dr. Weidenbaum, Mr. Gray, and I shall be happy to address any
questions you might have.
4/27 TOTRANK
*
OFFICE OF THE VICE PRESIDENT
WASHINGTON
Filez.Relist
April 24, 1981
MEMORANDUM FOR THE VICE PRESIDENT AND THE DIRECTOR
FROM:
C. Boyden Gray OBG
SUBJECT:
Status Report on Regulatory Relief
In Jim Miller's absence I am submitting this report on the Admin-
istration's regulatory relief initiatives during the past week.
Legislative Veto Testimony: Following consultation with the
Cabinet, Senior White House staff, and Task Force staff, the
Department of Justice presented the Administration's position
on legislative veto proposals in testimony before a Senate Judi-
ciary Committee subcommittee. (See Attachment 1.)
Handicap Legislation: Legislation pertaining to transportation
for the handicapped was discussed by the Vice President, the
Director, and the Secretary of Transportation. Tentative agree-
ment was reached to recommend legislation to shift the role of
ensuring nondiscrimination against the handicapped (in federally-
assisted mass transit systems) to the states and local govern-
ments. (See Attachment 2.)
The Task Force staff will meet with representatives from major
handicap groups on Monday afternoon.
Debt-Equity Regulations: The Department of the Treasury (Inter-
nal Revenue Service) has deferred until the end of calendar year
1981 regulations under section 385 of the Internal Revenue Code,
involving whether certain instruments are classified as debt
or equity. These regulations are quite controversial and appear
to raise major economic issues. Treasury, OMB and the Task Force
staff are reviewing the regulations under the Executive Order.
National Flood Insurance Program: In consultation with the Task
Force staff, the Federal Emergency Management Agency is recon-
sidering rules which, according to some estimates, would have
an impact of over $200 million annually and severely curtail
coastal development. The Agency has decided to postpone the
regulations, which were previously scheduled to take effect May 1.
2
Lead Rules: The Department of Labor has asked the Supreme
Court to remand to it its rule concerning occupational expo-
sure to lead. Like the cotton dust rule, the lead rule will
be reconsidered pursuant to a benefit-cost review. (See Attach-
ment 3.)
Patient Package Inserts: On Thursday Secretary Schweiker
announced that the commissioner of Food and Drugs will conduct
a full review of the need for patient package inserts. The
effective date of a pilot program requiring patient package
inserts in five new classes of drugs will be postponed pending
this review. (See Attachment 4.)
Sex Discrimination Regulations: The Department of Education
issued a notice of proposed rulemaking to withdraw the portion
of its antidiscrimination regulations pertaining to dress codes.
Under this provision, a school district could be refused Federal
financial assistance if it was found to have dress codes that
discriminate on the basis of sex. (See Attachment 5.)
(
Department of Justice
JUSTITIA
STATEMENT
OF
THEODORE B. OLSON
ASSISTANT ATTORNEY GENERAL
OFFICE OF LEGAL COUNSEL
BEFORE
THE
SUBCOMMITTEE ON AGENCY ADMINISTRATION
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
CONCERNING
S. 890 - LEGISLATIVE VETO
ON
APRIL 23, 1981
Statement of Theodore B. Olson
Assistant Attorney General, Office of Legal Counsel
Department of Justice
Before the Subcommittee on Agency Administration
of the Senate Committee on the Judiciary
April 23, 1981
Mr. Chairman and Members of the Subcommittee:
INTRODUCTION
It is a pleasure to appear before you today to present
the views of the Department of Justice regarding S. 890, the
proposed Regulatory Reduction and Congressional Control Act
of 1981.
Before I address the specific provisions of S. 890, I
would like to make a few general comments concerning the generic
term "legislative veto". This is an expression which has been
used to embrace an extremely wide category of Congressional
oversight mechanisms over administrative functions or actions.
Tension has existed between the Legislative and Executive Branches
for decades over this subject, arising from the quite natural and
appropriate tendency of the Executive Branch to seek to protect
its constitutionally ordained functions and responsibilities
while, at the same time, Congress seeks by various means to insure
that when it delegates authority, the powers delegated are exercised
in a responsible and proper fashion.
The Constitution is an instrument which derives much of
its strength from its flexibility. It is not useful or correct
to say that all governmental functions are divided into three
totally separate and categorical spheres, Legislative, Executive
and Judicial. For example, the Senate provides its advice and
consent to certain Executive Branch appointments and the Executive
Branch has been permitted to exercise certain delegated and
prescribed rulemaking responsibilities. As has been said, the
three Branches are not hermetically sealed chambers.
Therefore, I cannot and should not address all oversight
mechanisms which might be characterized as legislative vetoes.
Some such mechanisms in the context in which applied may be quite
consistent with the constitutional scheme for the division of
responsibilities, and many may not. I will mention some methods
which I think may be constitutional later in my remarks. Many
would have to be decided by the courts. I will confine the bulk
of my comments to the bill which I have been invited to address,
S. 890.
This bill includes, in § 3, provisions under which one
House of Congress, acting in the absence of disapproval by the
other House, could invalidate a broad range of substantive
agency rules by adopting a resolution of disapproval or a resolu-
tion for reconsideration of a rule.
The broad and sweeping nature of the legislative veto
provisions in this bill represents an unconstitutional invasion
of the power of the Presidency. 1/ Taken as a whole, these
1/ Ten previous Presidents have opposed legislative veto devices
of various types. President Wilson was the first to veto legis-
lation containing a two-house legislative veto. Subsequently,
Presidents Hoover, Roosevelt, Truman, Eisenhower, Kennedy,
Johnson, Nixon, Ford and Carter expressed their opposition
to such mechanisms.
- 2 -
Congressional resolution mechanisms do not conform to the
procedures for legislative action prescribed in Article I,
Section 7, Clauses 2 and 3 of the United States Constitution.
They are also objectionable from a constitutional standpoint
because they violate the general principle of the separation
of powers that is so basic to our constitutional scheme of
national government, and that is embodied in the Constitution's
overall structure and in several of its specific provisions,
including Article I, Section 7, Clauses 2 and 3. The carefully-
considered conclusion of the Attorney General is that the
Congressional resolution mechanisms in § 3 of S. 890 are
unconstitutional.
I hasten to add at the outset that this does not mean
that Congress lacks other means to assert its constitutional
authority to oversee and guide the exercise of delegated
power by federal agencies. There are actions which Congress
could take to deal with specific regulatory schemes. Furthermore,
we wish to emphasize that notwithstanding the position of
this Administration on the so-called "legislative veto"
devices contained in § 3 of S. 890, we share with supporters
of this legislation a strong interest in improving the operation
of the federal regulatory process and in controlling abuses
in the exercise of delegated powers. The Department of
Justice concurs that federal agencies should be responsive
to the will of the people as expressed through their elected
representatives.
- 3 -
I will first briefly discuss the major elements of
the Congressional resolution mechanisms in § 3 of S. 890,
on which my testimony will focus. I will then state the
Department's constitutional objections to those mechanisms,
which objections are particularly acute here due to the
sweeping nature of the veto provisions in this proposed
legislation. Finally, I will address the theme which I
mentioned at the outset that, apart from the mechanisms
contemplated by § 3 of S. 890, there are other, constitutional
means by which Congress can control the agencies' implementation
of public law and correct the abuses in it that are perceived to
exist.
I
Section 3 of S. 890 would amend title 5, United States
Code, by adding a new chapter 8, entitled "Congressional Review
of Agency Rulemaking." The new chapter, which would govern
most substantive rulemaking, would establish authority for
either House of Congress to adopt a resolution of disapproval
or a resolution for reconsideration of an agency rule. All
existing and proposed agency rules would be subject to the
review mechanisms established by S. 890 except those relating
generally to internal agency functions or those which repeal
or grant exemptions to the applicability of rules. Resolutions
- 4 -
of disapproval by a single House of Congress would purport to
nullify proposed agency rules unless the other House of Congress
disapproved of the original House's resolution of disapproval
within a stated period. Resolutions of reconsideration by a
single House of Congress would nullify existing rules unless
such rules were readopted by an agency and resubmitted as
recommended rules to Congress.
Under proposed § 802 (with the limited exceptions
noted above), rules promulgated by agencies pursuant to their
statutory authority would no longer be considered final upon
publication. Rather, they would be viewed as "recommendation [s]
of the agency to the Congress," and would have no force and
effect if either House of Congress adopted a resolution of
disapproval within 60 days of continuous session of Congress,
and the other House of Congress did not disapprove the first
House's resolution within an additional 30 days of continuous
session. These time periods would begin to run when the agency,
upon publishing a "recommended final rule" in the Federal Register,
transmitted it to the Secretary of the Senate and Clerk of the
House of Representatives. If a "recommended final rule" were
disapproved under these provisions, the affected agency would
be able to issue another "recommended final rule" relating to
the same subject matter, but any such reformulation would itself
- 5 -
have to be adopted in a manner complying with the procedures
summarized above.
Under § 803 of the proposed legislation, most existing
rules and regulations could be unilaterally repealed by a
resolution for reconsideration by one House of Congress. If
such a resolution were passed, the existing rule would lapse
unless resubmitted by the agency to Congress as a recommendation.
The recommendation could become law only if not disapproved by
one House or if a resolution of disapproval were overridden by
the other House.
As S. 890 is written, resolutions of disapproval or
reconsideration can be based upon any factors deemed "appropriate."
In short, virtually all exercises of rulemaking powers delegated
by law to an agency would become, under S. 890, mere recommen-
dations to Congress which could take effect only with the passive
acquiescence of both Houses of Congress or the affirmative support
of one House.
II
The Department of Justice has two fundamental constitutional
objections to the provisions in S. 890 that authorize the adoption
of resolutions of disapproval and resolutions for reconsideration
of agency rules. First, we believe that these provisions
violate the constitutionally prescribed procedure by which
- 6 -
legislative action must be taken. Second, we believe that to
the extent that the Congressional resolution provisions do not
call for legislative action as such (and thus are not subject
to the constitutionally specified procedures for such action),
they are contrary to the constitutional precept of the separation
of powers.
A
A fundamental principle of our Constitution is that the
exercise of legislative power by Congress must follow certain
procedures as prescribed in Article I, Section 7, Clauses 2 and
3. The process of Congressional review contemplated by S. 890
is inconsistent with these procedures. Article I, Section 7,
Clause 2 provides that every bill "before it becomes [s] a law"
shall have passed both Houses of Congress and shall be presented
to the President for his approval or veto. If the President
vetoes a proposed law, it may be passed over his objection only
by a two-thirds vote of both Houses. Thus, the exercise of
legislative authority requires the concurrence of both Houses of
Congress and the President, or, if the President does not approve
a bill, the concurrence of two-thirds of both Houses after the
President has vetoed the bill and expressed his objections to it.
The possibility that this procedure could be evaded
through an exercise of legislative power by some means other
- 7 -
than a "bill", a "resolution" for example, was foreclosed by
the Framers, who provided in Article I, Section 7, Clause 3,
which in many respects tracks the language of Clause 2, that
"[e]very Order, Resolution, or Vote" requiring concurrent
action (except resolutions of adjournment) "shall be
presented to the President," who may approve or veto the
proposal. Like Clause 2, Clause 3 provides that after a
proposal is vetoed, it may still become the law if it is
subsequently passed by a two-thirds vote of both Houses. Thus,
Clause 3, read in conjunction with Clause 2, makes plain that
the Framers intended that all exercises of legislative power
having the substantive effects of legislation, even if not
its traditional form, must follow the specified procedure.
The history of the adoption of Clauses 2 and 3 confirms that
conclusion. During the debate on the Presidential veto
provision, James Madison observed that
if the negative of the President was
confined to bills: it would be evaded
by acts under the form and name of
2/ Article I, Section 5, Clause 4 prevents adjournments for
more than three days without the consent of each House. Because
such adjournments thus must be accomplished by concurrent action,
a specific proviso in Article I, Section 7, Clause 3 was necessary
to prevent Congress from having to submit adjournment resolutions
to the President. It would be inappropriate for Congress to
have to present adjournment resolutions to the President for
his approval or veto, since the President is able to convene
Congress in any event. See Article II, Section 3; S. Rep.
No. 1335, 54th Cong., 2d Sess. 6 (1897).
- 8 -
Resolutions, votes [etc. He] proposed that
"or resolve" should be added after "bill"
....,
with an exception as to votes of
adjournment [etc.]
5 Elliot, Debates on the Federal Constitution 431 (1845).
Although Madison's proposal was initially rejected, it was
renewed during the following day's session by Mr. Randolph,
who put the proposal in a new form (substantially as it now
appears), whereupon it was adopted by a 9 to 1 vote. 2 Farrand,
Records of the Federal Convention of 1787, 201-05 (rev. ed.
1937).
Thus, both the language and the history of Clauses 2
and 3 demonstrate that the Framers intended that all exercises
of legislative power having the effect of legislation, even if
not in the form of "bills," must follow the specified procedure,
which includes passage by both houses of Congress and then
presentation to the President. 3/ The provisions of S. 890
3/ Exercises of legislative power having the substantive effect
of legislation and subject to the procedures of Article I,
Section 7, are distinguishable from: (1) acts that may be
taken by one or both Houses of Congress or their Committees
because they are merely in aid of Congress' legislative power
and do not purport to bind the Executive Branch, such as investi-
gations, oversight hearings, or requests for information from
the Executive Branch; and (2) acts by one or both Houses of
Congress expressly authorized by a constitutional provision
that does not require the procedures in Article I, Section 7.
The latter class of actions includes the power of the House to
impeach (Article I, Section 2, Clause 5); the Senate's power
to convict following impeachment (Article I, Section 3, Clause 6)
and to ratify treaties and pass upon Presidential nominations
(Article II, Section 2, Clause 2); the power of both Houses to
pass a concurrent resolution of adjournment that is not presented
(continued)
- 9 -
that would authorize resolutions of disapproval or resolutions
for reconsideration which would nullify the effectiveness of
agency rules are exercises of legislative power. Indeed, if
the provisions did not purport to be such, they could only
be exercises of executive or judicial power, which, as will
be discussed subsequently, would violate the constitutional
principle of separation of powers. Therefore, the provisions
of S. 890 are subject to the procedures specified in Article I,
Section 7, Clauses 2 and 3. However, S. 890 contravenes those
requirements in two respects: first, the bill does not require
the affirmative passage of a resolution by both Houses of Congress;
second, it does not permit the President to exercise his power to
approve or veto that resolution after both Houses of Congress
have given their concurrence to it.
1.
Article I, Section 7, Clause 2 assumes that both
Houses of Congress must act before a bill is to be presented
to the President by providing that "[e]very Bill which shall have
passed the House of Representatives and the Senate, shall, before
3/ (continued)
to the President (Article I, Section 7, Clause 3) ; and the
power of each House to establish its own legislative procedures
(Article I, Section 5, Clause 2). See also Article V and
Hollingsworth V. Virginia, 3 U.S. (3 Dall.) 378 (1798) (power
of both Houses by a two-thirds vote to propose constitutional
amendments). In addition, of course, one or both Houses of
Congress can employ a resolution as a means of expressing an
opinion of the House that purports to have no binding effects
on the Executive branch.
- 10 -
it become a Law, be presented to the President
"
(emphasis
added). Article I, Section 7, Clause 3 speaks of every order,
resolution or vote "to which the Concurrence of the Senate and
House of Representatives may be necessary (except on a question
of Adjournment)", without identifying the orders, resolutions,
or votes regarding which such concurrence is necessary. However,
reading Clause 3 in conjunction with Clause 2, it is evident
that under Clause 3 concurrent action is necessary when the order,
resolution or vote would have the same substantive effect as
"bills" mentioned in Clause 2, that is, when an order, resolution
or vote is an exercise of legislative power in a form other
than a "bill," but having the same substantive effect. 4/ This
conclusion is buttressed by the language of Article I, Section 1,
which vests "[a] 11 legislative Powers herein granted" in "a
Congress of the United States, which shall consist of a Senate
and House of Representatives" (emphasis added). The bicameralism
4/ See S. Rep. No. 1335, 54th Cong., 2d Sess. 1-2, 6-8 (1897).
Any suggestion that by assigning "veto" power to one House,
rather than both, Congress may avoid the strictures of Article I,
Section 7, Clause 3 would appear to be a constitutional absurdity.
See Watson, Congress Steps Out: A Look at Congressional Control
of the Executive, 63 Cal. L. Rev. 983, 1066 n. 428 (it "verges
on irrationality to maintain that action by concurrent resolution,
whereby Congress is at least held in check by its own structure,
is invalid because the veto clause so states, but that the invali-
dity of a simple resolution, wherein a single House acts without
check, is more in doubt"). As another commentator put it: "It
surely must be true that a power not permitted to both houses
of Congress by the Constitution cannot suddenly be made available
by delegating it to one house." J. Bolton, The Legislative Veto,
Unseparating the Powers 39 (AEI 1977).
- 11 -
principle of Article I, § 7 contemplates actual passage of a
resolution by both Houses -- not mere passive "acceptance" or
simple silence by one of the two Houses with respect to the
action of the other House. Accordingly, all exercises of
legislative power having the substantive effect of legislation
require passage by both Houses of Congress. See The Federalist
Nos. 49 & 51. Because the provisions of S. 890 contravene
the bicameralism principle, they are invalid.
2.
The importance of the second requirement of Article I,
Section 7, Clauses 2 and 3 -- that legislative action must be
presented to the President before it may become law -- lies in
the fact that the Presidential veto is a vital element of our
constitutional system of checks and balances, operating as a
check to ensure the wisdom of legislation and as a protection
against congressional encroachment on the President's constitu-
tional authority. See The Federalist Nos. 48 & 73; 2 Farrand,
Records of the Federal Convention of 1787, 299-300, 586-87
(rev. ed. 1937). The Framers feared that, absent a Presidential
veto, "the legislative and executive powers might speedily
come to be blended in the same hands." The Federalist No. 73
at 469 (Wright ed. 1961). The Framers also considered that
the President's veto power could operate on behalf of the
public interest as a protection against the effects of special
interests in our public life. See The Federalist No. 73. The
Congressional resolution mechanisms in S. 890 purport to authorize
- 12 -
one House of Congress, acting without the disapproval of the other
House, to exercise legislative power by means of a resolution that
is not presented to the President for his approval or veto.
Therefore, S. 890 is unconstitutional.
It might be argued that the "resolution of disapproval"
and the "resolution of reconsideration" and the accompanying
procedures do not constitute the making of substantive legislation.
However, a straightforward analysis of the process reveals that it
does constitute such action. In the typical situation, Congress
delegates rulemaking authority to an agency to implement policy
objectives mandated by Congress. Agency regulations adopted
pursuant to such a delegation have the force and effect of
law if they are within the substantive authority of the statute
delegating the rulemaking power. See, e.g., Chrysler Corp. V.
Brown, 441 U.S. 281 (1979). Such a statutory delegation, requiring
the concurrence of both Houses and presentation to the President,
may be withdrawn or modified only by following the same procedure
for legislation. Yet S. 890 would erect a fundamentally different
scheme. Section 3 would encompass situations where regulations
are being and have been promulgated pursuant to a statutory dele-
gation. S. 890 would convert agency regulations into "recommendations"
and existing rules, if one House passes a resolution of reconsidera-
tion, into nullities. In either case, under S. 890, Congressional
- 13 -
inaction or affirmative action by one House would suffice for
the regulations to become law; the action of one House with the
passive acquiescence of the other would suffice to nullify them.
B
The second main constitutional objection to the Congressional
review provisions of S. 890 is that, to the extent they permit
Congress to reserve to itself powers vested by the Constitution
in the Executive and Judicial Branches, they violate the principle
of separation of powers. This principle, a cornerstone of our
Constitution, is directly reflected in the Constitution's
structure, which establishes the three branches of government
in Articles I, II, and III, respectively. It is also reflected
in several specific provisions, including Article I, Section 7,
Clauses 2 and 3 (the presentation clauses) ; Article I, Section 6
(the incompatability and disability clauses) ; and Article II,
Section 2, Clause 2 (the appointment clause). See generally
Buckley V. Valeo, 424 U.S. 1, 120 (1976).
The principle of the separation of powers is based
on the premise that if one branch of government could, on its
own initiative, merge legislative, executive, or judicial powers,
it could easily become dominant and tyrannical -- for it would
not be subject to the checks on governmental power that the
Framers considered a necessary protection of freedom. See The
- 14 -
Federalist No. 47. At the same time, the principle does not
assume that the three branches of government are "watertight
compartments" acting in isolation of each other. See Springer V.
Philippine Islands, 277 U.S. 189, 211 (1928) (Holmes, J.,
dissenting) ; Youngstown Sheet & Tube Co. V. Sawyer, 343 U.S.
579, 635 (1952) (Jackson, J., concurring). Rather, the Framers
conceived of the process of national government as one of
dynamic interaction between the three branches, with each.
"checking" the others and "balancing" the powers conferred on
the others with its own assertions of power. At the core of
this concept is the precept that no single Branch can usurp
or arrogate to itself the essential functions of the other
Branches. The boundary between legislative and executive action
is set in the first instance by Congress, when it decides how
much discretion to delegate to the Executive in implementing
policies set by statute. Once the delegation is made, however,
implementation of the statutory policies is an Executive func-
tion -- indeed, it is the core of the Executive function. The
statute sets a boundary beyond which the Executive may not go
without intruding on the legislative function. It also sets
a boundary within which the Executive must be allowed to func-
tion without Congressional overruling except through the
- 15 -
constitutional process of legislation. Otherwise Congress
would exercise the essence of the Executive function.
This principle is violated by S. 890 to the extent that
the bill would give to the Houses of Congress the power to
intervene, apart from the passage of legislation, directly in
the process by which the Executive branch implements substantive
legislation by means of rulemaking. S. 890 effectively transforms
all covered rulemaking into tentative action, rather like that
of a Congressional committee, having no force and effect of its
own, but merely achieving legal status if Congress does not
disapprove it. In essence, S. 890 sets up the Houses of
Congress as final administrative authorities on the whole range
of regulatory matters. As such, it impermissibly authorizes
Congress effectively to exercise the power to execute the law
that Article II lodges in the President and the Executive branch.
S. 890 would apply to most rulemaking by all agencies
of the Executive Branch. The intrusion that it would establish
into the powers of the Executive to implement the laws and to
exercise the powers delegated to it would be pervasive, far-
reaching, and long-standing. It would cause a major change
in the powers of the coordinate branches. Also, in light of
the alternatives which will be discussed in a few moments, it
is not necessary.
- 16 -
Furthermore, S. 890 invades the constitutional prerogatives
of the Judiciary. "It is emphatically the province and duty
of the judicial department to say what the law is. " Marbury V.
Madison, 4 U.S. (1 Cranch) 137, 177 (1803) ; see The Federalist
No. 78 (Hamilton). The Congressional review provisions of
S. 890 purport to delegate to Congress the power, by means
of a resolution of disapproval or a resolution for reconsidera-
tion, to declare what a preexisting statute requires with
respect to regulatory action or to determine that a rule is in
conflict with judicial decisions. As a consequence, S. 890
would shift to Congress power that the Constitution reposes in
the courts and the courts alone.
C
Although the provisions of S. 890 are different in
some respects from the classic one-house "legislative veto"
provisions, they do not escape the full force of these
constitutional objections.
First, there is no meaningful distinction to be drawn
between Congressional review of rulemaking (covered by this
bill) and other types of agency action in terms of the relevant
constitutional norms. Rulemaking is a form of Executive action,
see Buckley V. Valeo, supra, 424 U.S. at 140-41, and therefore,
like other such actions, is lodged in the Executive Branch
- 17 -
under Article II of the Constitution. The distinction between
rulemaking and other forms of Executive action carries no weight
with respect to compliance with the constitutionally-prescribed
procedure for the exercise of legislative power. Article I,
Section 7, Clauses 2 and 3, dictate the procedures to be followed
by all legislative action having the force of law and not
otherwise covered by specific constitutional sections providing
a different procedure, regardless whether the action affects
rulemaking, adjudication, or other actions of agencies.
It could be suggested that the adoption of a resolution
of disapproval or reconsideration under S. 890 is not really
an exercise of legislative power subject to the procedures
prescribed in Article I, Section 7, Clauses 2 and 3, but rather
is a condition on the exercise of agency discretion under other
statutes that give agencies rulemaking power. Viewed in that
light, original grants of rulemaking discretion to agencies
under other statutes would be changed to "conditional delegations",
rather like grants of statutory power made contingent on findings
of fact by an Executive officer, or upon the favorable vote of
persons who will be affected by proposed governmental action.
See H.R. Rep. No. 120, 76th Cong 1st Sess. 6 (1936). The
problem with such a suggestion is that it assumes that the
delegation of power to a person or entity outside the Legislative
- 18 -
Branch is constitutionally equivalent to the delegation of
power to the Housesof Congress, which are within the Legislative
Branch and thus subject to the strictures of Article I. That
assumption is insupportable. Any attempted analogy between
S. 890 and "conditional legislation" simply fails to take account
of the core constitutional issue, namely, the application of
the procedural requirements of Article I, Section 7, Clauses2
and 3, to exercises of power by Congress that have the substantive
effect of legislation.
It is no response to the constitutional objections that
are inherent in S. 890 to assert that its Congressional reso-
lution mechanisms are authorized by the Necessary and
Proper Clause, Article I, Section 8, Clause 18, which grants
Congress power to "make all Laws which shall be necessary and
proper for carrying into Execution the foregoing [enumerated]
Powers and all other Powers vested by this Constitution in
the Government of the United States, or in any Department or
officer thereof." The exercise of power by Congress pursuant
to the Necessary and Proper Clause is limited by other express
provisions of the Constitution, such as Article I, Section 7,
Clauses 2 and 3, and by the principle of the separation of
powers. See Buckley V. Valeo, supra, 424 U.S. at 135. As
the Court of Appeals for the Ninth Circuit noted in Chadha V.
INS, 634 F.2d 408, 433 (1980), the Necessary and Proper Clause
"authorizes Congress to 'make all laws', not to exercise power
in any way it deems convenient. That a power is clearly committed
- 19 -
to Congress does not sustain an unconstitutional form in the
exercise of the power."
III
While the Department of Justice believes that the
Congressional resolution mechanisms in S. 890 are
unconstitutional, and is taking that position in pending
litigation, 5/ we would stress that there are many fully consti-
tutional legislative and oversight mechanisms -- some of which
5/ Among the pending cases is Consumer Energy Council of
America V. Federal Energy Regulatory Commission, Nos. 80-2184,
80-2312, pending before the District of Columbia Circuit Court of
Appeals. Also, this Department has filed a notice of appeal to the
Supreme Court on behalf of the Immigration and Naturalization
Service in INS V. Chadha, 634 F.2d 408 (9th Cir. 1980). The
only federal court yet to reach the issue of the constitutionality
of "legislative veto" devices, other than the Chadha court, is
the Court of Claims in Atkins V. United States, 556 F.2d 1028
(Ct. Cl. 1977), cert. denied 434 U.S. 1009 (1978). The 4-3
holding of the Court of Claims in that case was narrowly restricted
to the context of the Federal Salary Act, 2 U.S.C. 869 (1) (B).
See 556 F.2d at 1059. Three of the seven judges forcefully
disagreed with the per curiam opinion on the legislative veto
device under consideration there. Cf. Buckley V. Valeo, 424
U.S. 1, 140 n. 176 (1976) (declining to address the question of
the validity of a one-house "legislative veto" provision in
the Federal Election Campaign Act, 2 U.S.C. 438 (c), an issue not
briefed by the United States) id. at 257 (White, J., concurring
in part and dissenting in part) (concluding that the "legislative
veto," at least as applied to so-called "independent agencies,'
not a usurpation of President's constitutional power) ; McCorkle
V. United States, 559 F.2d 1258 (4th Cir.) (declining to reach
the issue of the constitutionality of the same provision of the
Federal Salary Act that was at issue in Atkins, supra, on the
ground that the provision was not "severable" from the rest of
the statute and, therefore, even if the statute were held
unconstitutional, plaintiff would have no right to additional
pay), cert. denied 434 U.S. 1011 (1978) Clark V. Valeo, 559
F.2d 642 (D.C. Cir.) (en banc) (declining to consider
constitutionality of "legislative veto" provision of Federal
Election Campaign Act on grounds that issue not ripe for
adjudication), aff'd mem. sub nom. Clark V. Kimmitt, 431 U.S.
950 (1977).
- 20 -
might conceivably be characterized as legislative vetoes -- that
Congress can use to achieve the goals underlying S. 890.
In organic statutes, Congress can and should place specific
and precise limits on the authority of agencies to issue rules.
Moreover, Congress can always override unwise, inappropriate,
burdensome, or excessive agency rules with legislation. To
the extent that the procedural hurdles within Congress that
impede the enactment of legislation have fostered proposals such
as S. 890, Congress can adopt legislation assuring early floor
consideration of bills overturning agency rules.
Congress can also authorize an agency to act for a
limited period of time, thereby forcing the agency to return
to Congress for authority to continue to act when its authoriza-
tion expires. Congress, of course, can hold oversight hearings,
at which explanations for agency rules that members of Congress
may question can be sought and made part of a public record.
Congress can adopt resolutions expressing its views which,
while not legally binding upon the Executive branch unless
they conform to the plenary legislative process specified in
Article I, Section 7, Clauses 2 and 3, can guide an agency in
its implementation of the law. Further, Congress has the
authority for appropriating the money with which agencies
execute the law, and in appropriation statutes Congress can
provide for limitations on the expenditure of agency funds
for certain purposes, consistent with any other applicable
legal requirements.
- 21 -
This Administration has demonstrated that it has the
desire and ability to move swiftly to begin to accomplish
the objectives which underlie S. 890. As early as January 29,
1981, the Administration moved to postpone the effectiveness
of certain regulations and, by Executive Order No. 12291, issued
on February 17, 1981, the President began the important process
of reducing the burdens of existing and future regulations,
increasing agency accountability, and increasing Presidential
oversight of the regulatory process. Congressional oversight
of this process is appropriate and will be welcomed by this
Administration. The best procedure perhaps would be use of joint
Congressional resolutions providing an opportunity for a Presidential
veto and a Congressional override of that veto in the rare case
in which it might occur. This method would be constitutionally
appropriate and would include all elected officials in the process.
CONCLUSION
The point to be underscored is not that the Constitution
places insuperable hurdles in the path of Congress as it seeks
to insure that federal agencies remain accountable and live
within the limits ordained by Congress. Rather, Congress has at
its disposal a large number of tools. At the same time, the use
of these tools must be attentive to the strictures of the Consti-
tution. In the view of the Department of Justice, the Congressional
resolution mechanisms contained in S. 890 run afoul of that
basic charter. They may seem more efficient in the short run, but
that has never been adequate justification for such a substantial
alteration of the constitutionally ordained separation of powers.
- 22 -
DOJ-1981-04
22764
Federal Register / Vol. 46, No. 76 / Tuesday, April 21, 1981 / Proposed Rules
DEPARTMENT OF HEALTH AND
micrograms of lead per cubic meter of
Additional protective provisions such as
HUMAN SERVICES
air (50 µg/m³) averaged over an eight-
environmental monitoring,
hour day, and of the medical removal
recordkeeping. employee education and,
Food and Drug Administration
protection provision of the regulation.
training. medical surveillance. medical
21 CFR Part 864
will be subject to analysis. Additionally.
removal protection. and hygiene
for a few industries where employees
facilities, were included in the standard.
[Docket No. 78N-1835]
appear to be exposed to lead on an
Supplemental attachments were
Medical Devices; Classification of Dye
intermittent basis, the question whether
published on November 21, 1978 (43 FR
Powder Stains; Withdrawal of
the employees face a significant risk of
54354).
lead-related disease will be addressed.
Proposed Rule
Immediately after promulgation, the
At this time, public participation is
lead standard was challenged by both
Correction
invited on the issues raised by such
industry and labor groups in the United
In ER Doc. 81-10035 appearing on
reevaluation and as to whether other
States courts of appeals. All cases were
page 20221 in the issue for Friday. April
matters relating to the hazards and
transferred and consolidated in the U.S.
3. 7981, make the following correction:
regulation of lead should be addressed.
Court of Appeals for the District of
On page 20221, in the first column, in
DATES: Comments. suggestions and
Columbia Circuit. On March 1, 1979, the
the document heading. the Docket No.
information are invited regarding this
D.C. Circuit partially stayed the lead
was printed incorrectly. It should have
Advance Notice of Proposed
standard by delaying the requirement
read as printed above.
Rulemaking by June 1, 1981.
for installing engineering controls and
BILLING CODE 1505-01-M
ADDRESS: Comments should be
instituting work practices. However, the
submitted to the Docket Officer,
requirement to meet the PEL using
Occupational Safety and Health
respirators, and provisions for
DEPARTMENT OF LABOR
Administration. Docket No. H-004E.
environmental monitoring.
Room S-6212, U.S. Department of Labor,
recordkeeping. employee education and
Occupational Safety and Health
3rd and Constitution Avenue, N.W..
training. medical surveillance, and
Administration
Washington, D.C. 20210.
medical removal protection were not
29 CFR Part 1910
FOR FURTHER INFORMATION CONTACT:
stayed and became effective on March
James Foster, Occupational Safety and
1, 1979.
[Docket No. H-004E]
Health Administration, Room N3637,
In an opinion issued on August 15,
U.S. Department of Labor, Washington.
1980, the court of appeals upheld the
Occupational Exposure to Lead
D.C. 20210. Telephone (202) 523-8151.
validity of OSHA's lead standard in
AGENCY: Occupational Safety and
SUPPLEMENTARY INFORMATION:
most respects. acknowledging that a
Health Administration (OSHA),
number of important questions on
Department of Labor.
1. Introduction
appeal were "very close." The court
ACTION: Advance notice of proposed
On October 3, 1975, the Occupational
rejected the industry petitioners'
rulemaking.
Safety and Health Administration
contentions that they had not received
(OSHA) proposed a standard for
notice that OSHA might set a
SUMMARY: Notice is given that the
occupational exposure to lead (40 FR
permissible limit below the 100 µg/m³
Occupational Safety and Health
45934) which would limit the maximum
standard that was initially proposed.
Administration will shortly be
permissible lead exposure (PEL) of
and that OSHA had improperly relied
undertaking. through rulemaking
employees to 100 µg/m³ (micrograms of
on information not in the public record
procedures under section 6 of the
lead per cubic meter of air). The new
in reaching its decisions on the
Occupational Safety and Health Act of
standard was to supersede the previous
standard. The court also concluded that
1970. a reevaluation and reconsideration
national consensus standard which
OSHA's finding of a health need to
of the occupational health standard
limited lead exposure to 200 µg/m³, and
reduce the permissible lead limit was
regulating exposure to lead. 29 CFR
which had been adopted by OSHA
consistent with the Supreme Court's
1910.1025. The purpose of this
pursuant to section 6(a) of the
decision in Industrial Union Dept V.
proceeding is to review the
Occupational Safety and Health Act
American Petroleum Institute, No. 78-
technological and economic feasibility
(Act). The proposal explained that the
911 (July 2. 1980). which required OSHA
of complying with the regulation. The
necessity for a more stringent and
to show that employees will face a
economic consequences of the
comprehensive regulation was based on
"significant risk" of harm if a new
regulation will be reexamined on two
the substantial body of scientific and
regulation is not issued. The court of
bases. First, the affected industries'
medical evidence showing that lead has
appeals additionally concluded that the
ability to comply with the standard will
adverse effects on the health of workers
medical removal protection provision
be reexamined. Second, a cost-benefit
in the lead industry: that evidence
was authorized by the statute, that it
analysis will be performed, in order to
showed that lead results in damage to
was reasonably necessary. and that it
assess the practicality of relying on this
the nervous, urinary and reproductive
was affordable by industry.
approach in setting occupational health
systems. and inhibits synthesis of the
With respect to feasibility. the court of
standards in the context of a specific
molecule heme, which is responsible for
appeals found that feasibility simply
regulation. A parallel reevaluation will
oxygen transport in living systems.
meant "capable of being done," without
be performed for the cotton dust
Informal rulemaking proceedings were
regard to whether the costs are justified
standard. See 46 FR 19501 (March 31.
conducted on the proposal. On
in light of the benefits. On that basis, the
1981).
November 14, 1978. a final standard
court affirmed OSHA's finding that the
All provisions of the lead standard
which limited occupational exposure to
following ten industries could feasibly
will be subject to reexamination. In
airborne concentrations of lead to 50
comply with the 50 µg/m³ PEL through
particular, the economic and
µg/m³ based on an 8-hour time weighted
engineering and work practice controls:
technological feasibility of the present
average (TWA) was published in the
primary smelting: secondary smelting:
permissible exposure limit of 50
Federal Register (43 FR 52952).
printing; can manufacturing: battery
Federal Register / Vol. 46, No. 76 / Tuesday, April 21, 1981 / Proposed Rules
22765
manufacturing; paint and coatings
rulemaking record and scheduled a
and the 50 µg/m³ PEL. In addition, LIA
manufacturing; ink manufacturing:
hearing for the purpose of soliciting
has alleged that the findings of
wallpaper manufacturing; electronics
additional information pertaining to the
economic and technological feasibility
manufacturing; and gray-iron foundries.
technological and economic feasibility
are inadequate or unsupported for the
However. the court found that OSHA
of meeting the 50 µg/m³ PEL solely by
following seven industries or operations:
had failed to present substantial
engineering and work practice controls.
copper smelting, nonferrous foundries,
evidence or adequate reasons to support
Other issues, such as the significance of
silver refining. spray painting.
the feasibility of the PEL in the
the risk employees face in particular
stevedoring. steelmaking. and zinc
remaining industries, and remanded the
industries, and the propriety of reliance
smelting and refining. The Shipbuilders
record to the agency for reconsideration
on cost-benefit analysis in setting
Council has maintained that the
of that issue.
standards, were not reopened. OSHA
shipbuilding and repair industry should
The court directed OSHA to return the
set time periods for the submission of
be exempted from the lead standard
standard with full explanations within
comments and notices of intention to
because: the agency failed to make
six months. The court also continued, for
appear at the hearing (by October 27.
those industries subject to the remand,
adequate findings of the technological
1980), and for the informal public
the limited stay that had been in effect
and economic feasibility of compliance:
hearing (November 5-7, 1980). The
pending review. With respect to the ten
reliance on engineering controls is
record remained open for the receipt of
industries for which the standard was
unwarranted: and the high mobility and
additional comment and data until
held fully applicable, the stay was
high turnover of the workforce makes
December 1, and for posthearing
dissolved.
regulation unnecessary and
argument until December 10, 1980.
Since the issuance of court of appeal's
inappropriate. South Central Bell and
On January 13, 1981, OSHA issued its
August 15 decision, proceedings have
AT&T have maintained the
supplemental statement of reasons with
taken place simultaneously before the
telecommunications industry should be
regard to the technological and
Supreme Court and the agency.
exempted for similar reasons.
economic feasibility of the PEL for 46
Organizations representing the primary
specified industries or occupations (46
Several industry groups (including LIA
lead smelters (Lead Industries
FR 6134, Jan. 21, 1981). For most of the 46
and the Secondary Lead Smelters
Association, or LIA) and the secondary
categories, OSHA found that the
Association) have also requested that
lead smelters (National Association of
standard was feasible. For a few
the next "trigger" making the medical
Recycling Industries, Inc., or NARI),
industry categories, OSHA found that
removal provision more stringent, which
sought a stay pending review by the
feasible control measures are available
was scheduled to go into March 1, 1981,
Supreme Court. On December 8, 1980,
the Supreme Court granted that request
but that an extension in the compliance
be suspended for one year. Beginning on
schedule was needed to assure the
March 1, the standard required that
in part, notably staying for all industries
feasibility of their implementation. For
workers be removed from high exposure
the requirement that the 50 µg/m³
some operations within certain
areas (with full pay) when their blood
standard be achieved through
engineering and work practice controls.
industries, OSHA found that respiratory
lead levels exceeded 60 µg/100g
protection may be the only
(micrograms of lead per 100 grams of
LIA and NARI subsequently filed
petitions for review in the Supreme
technologically feasible means of
whole blood): employers are also
compliance.
required to keep these workers from
Court, as did the South Central Bell
The supplemental statement of
such exposure until their blood lead
Telephone Company. In their petitions,
these groups alleged that the standard is
reasons was submitted to the D.C.
levels had been reduced below 40 µg/
invalid on numerous grounds, including
Circuit on January 19. Thereafter,
100g. See 29 CFR 1910.1025(k)(1)(i)(C)
because several industry groups
and (k)(1)(iii)(A)(3). The industry
lack of adquate notice; improper
informed the agency of their intention to
petitioners have claimed that
reliance by the agency on ex parte
contacts; absence of a finding of
file administrative requests for
implementation of the 60/40 trigger will
significant risk for employees whose
reconsideration of the remand decision,
compel the removal of skilled tradesmen
exposure is only intermittent: failure by
OSHA and the industry petitioners
in numbers that will severely affect
the agency to justify the standard on a
jointly filed a motion with the D.C.
plant production, and will be extremely
cost-benefit basis; absence of evidence
Circuit asking that further judicial
expensive. They have suggested that
supporting the technological and
proceedings be held in abeyance
OSHA's assumptions about compliance
economic feasibility of reaching the 50
pending the agency's action on the
through engineering controls (upon
µg/m³ PEL in the primary and secondary
reconsideration requests. The court has
which the correlating cost calculations
smelting industries; and lack of statutory
not yet acted on that motion.
for medical removal were premised).
authority for medical removal
The industry requests for
have lost all meaning because the
protection. The petitions are currently
reconsideration were filed with the
engineering control requirement has
pending before the Supreme Court and
agency on February 26 and 27, 1981. The
been stayed since the issuance of the
no decision as to whether the Court will
following parties, among others, filed
standard. The agency granted a thirty-
hear the case has been issued.
reconsideration requests: LIA the
day suspension of the trigger to study
Contemporaneous with this Advance
Shipbuilders Council of America, South
this request (46 FR 14897. March 3. 1981).
Notice, a memorandum in response to
Central Bell Telephone Company and
OSHA has also requested additional
the petitions is being filed with the
AT&T. LIA has alleged that the remand
information from the industry
Supreme Court asking that the Court
proceedings were procedurally
petitioners. A second delay of the
grant the petitions, vacate the judgment
defective. It has also asserted that the
effective date of the provision, until May
of the court of appeals, and remand the
standard is invalid due to the absence of
1, 1981, was published on March 27. 1981
rulemaking record to the agency.
industry-specific findings regarding the
(46 FR 18974).
With regard to the remanded
significance of the risk, as well as the
Finally. even apart from industry's
industries. OSHA published a Federal
absence of any cost-benefit or cost-
requests for reconsideration and stay
Register notice on September 24, 1980
effectiveness analysis justifying the
discussed above, the agency determined
(45 FR 63476) which reopened the
primary reliance on engineering controls
that the January 13 supplemental
22766
Federal Register / Vol. 46, No. 76 / Tuesday, April 21, 1981 / Proposed Rules
statement of reasons should be subject
additionally address whether, based on
that rather than retrofit existing
to review (46 FR 11254. Feb. 6, 1981).
the cost-benefit analysis, an individual
pyrometallurgical equipment, the
PEL should be set for each industry.
2. Reasons for Conducting a Proposed
primary lead smelting industry might opt
In the agency's view, all this
to comply with the standard by
Rulemaking
information and data, as well as the
rebuilding their production facilities to
OSHA has concluded that the lead
public input which will be provided in
utilize a new, cleaner, smelting process
standard should be reconsidered for
the rulemaking proceeding. will permit
called hydrometallurgy. OSHA based its
several reasons. First, a new rulemaking
the agency to produce a comprehensive
prediction that the hydrometallurgical
is appropriate because the agency has
and thorough cost-benefit analysis: This
process would be commercially
now concluded that it should reexamine
experience, plus the comparative
available within ten years (the time
the position, taken in issuing the lead
experience under other health and
period granted the primary smelting
rule and other standards, that it would
safety laws (a comparison mandated by
industry for compliance) on evidence
be inconsistent with the Act for OSHA
29 U.S.C. 655{b)(5)), will enable the
showing that a small scale laboratory
to get a toxic substance standard on the
agency to decide under what
experiment using the hydrometallurgical
basis of a cost-benefit analysis. That the
circumstances it is appropriate and
process was being conducted by the
appropriateness of cost-benefit analysis
practical to factor such an analysis into
Bureau of Mines. Since promulgation of
in the application of regulatory policy is
setting toxic substances standards.
the standard, that laboratory trial has
of vital concern to the national welfare
Second, even independent of cost-
been successfully completed, and a
and the national government is
benefit grounds, the agency has
larger scale pilot hydrometallurgical
evidenced by the recent establishment
concluded that it is appropriate to
project has been constructed. OSHA
of the Presidential Task Force on
reassess the technological and economic
believes that the data which can be
Regulatory Relief, chaired by the Vice-
feasibility of the 50 µg/m³ standard (i.e.,
obtained from this larger scale project
President, and the recently issued
the industries' ability to comply with the
may be useful in determining the precise
Executive Order No. 12291 which
standard). Since no data specifically
extent to which hydrometallurgy can
mandates such analysis in certain
addressing the feasibility of attaining
reduce ambient lead levels.
rulemakings (46 FR 13193). The policy
the 50 µg/m³ PEL was submitted at the
The data from the pilot
underlying that Order is that cost-
original rulemaking. the agency's
hydrometallurgical project, as well as
benefit analysis is a useful device in the
conclusion that the 50 µg/m³ PEL was
other new information, may also enable
regulatory decisionmaking process.
feasible was based on extrapolation
the agency to quantify the predicted
Other safety and health agencies,
from the evidence submitted concerning
although administering different statutes
costs of compliance with the 50 µg/m³
the proposed 100 µg/m³ PEL. The agency
with somewhat different purposes, have
level for the primary smelting industry.
believes that a more complete record
found that the cost-benefit technique or
The agency believes the costs of any
could be developed if affected parties
standard should be estimated if it is
variants thereof are useful in their
are given the opportunity to specifically
decisionmaking processes. See
address the propriety of a 50 µg/m³
possible to do so. OSHA's statement of
reasons to the lead standard, however,
Consumer Products Safety Commission,
as well as other PELs which could be
Proposed Methodology for Commission
did not specify the dollar costs of
set.
Consideration of Findings Under
And while the feasibility of the 50 µg/
compliance for this industry. Although a
Section 9(c) of the Consumer Products
m3 PEL in the "remand" industries was
quantification of the costs of achieving
Safety Act, 45 FR 85772 (Dec. 30, 1980);
addressed anew in the supplemental
compliance by innovative technology
Environmental Protection Agency,
administrative proceedings, the affected
may not have been possible at the time
National Emission Standards for
parties have suggested that the short
the standard issued, the new data may
Hazardous Air Pollutants; Policy and
time frame of that rulemaking was
provide the foundation for such a
Procedures for Identifying, Assessing,
inadequate to permit a proper record to
calculation.
and Regulating Airborne Substances
be developed. Moreover, the ten
Moreover, OSHA's review of the
Posing a Risk of Cancer, 44 FR 58642
industries for which the standard was
rulemaking record to the original
(1979). In consonance with the policy of
upheld in whole by the court of appeals
standard suggests that the data and the
the Executive Order, it is the agency's
were not given this supplemental
formula for computing the primary
view that it is appropriate to evaluate
opportunity to submit data. A new
smelting industry's costs of compliance
the practicality of cost-benefit balancing
rulemaking proceeding will remedy
with the 50 µg/m³ PEL using
by investigating the concept in the
these perceived deficiencies. It will
conventional controls are presently
context of an actual standard such as
thereby ensure that the standard which
available. No calculation was made by
lead, and in a manner which permits
is ultimately set is firmly grounded on
the agency prior to the standard's
public comment. A similar analysis will
the best available evidence.
promulgation. Since the rulemaking
be performed for the cotton dust
Reevaluation of the feasibility
record will be reopened, the.agency may
standard. See 46 FR 19501 (March 31,
question would appear to be particularly
be able to now compute these costs, and
1981).
warranted with regard to the primary
to subject the analysis to public
The agency intends to invite the
and secondary smelting industries
comment.
submission of all information relevant to
because the conclusion that the present
Similar revisions in the feasibility
an assessment of the relationship
standard is feasible for these industries
analysis for the secondary lead smelting
between the rule's benefits and its costs.
was premised in part on the possibility
industry may be warranted. In its
In particular, information will be sought
that innovative developments in process
statement of reasons, OSHA suggested
concerning the use of respirators as an
and control technology could contribute
that rather than retrofit existing
alternative to engineering controls. The
to significant air lead reductions. New
equipment, this industry might prefer to
interrelationships between the type of
information concerning the viability of
rebuild their production facilities using
economic analysis which OSHA has
these innovative technologies has now
the new Bergsoe SB furnace, which was
traditionally performed and cost-benefit
come to the agency's attention. For
in place in a secondary smelting facility
techniques will also be a subject of the
example, in the statement of reasons to
in Sweden that had achieved fairly low
new rulemaking. The agency will
the present standard, OSHA suggested
air lead levels. Industry questioned the
Federal Register / Vol. 46, No. 76 / Tuesday, April 21, 1981 / Proposed Rules
22767
utility of converting to the Bergsoe
industries, or by amending the standard
(5) Whether the relationship between the
furnace, claiming that the process will
to set a minimum number of days for
costs and benefits of any of the proposed
not assure the air lead reductions
which employees must be exposed
PELs is reasonable.
necessary to achieve the PEL, and that
above a certain level before the
(6) Whether different PELs should be set
the 90 million dollar cost of converting
compliance requirements of the
for different industries covered by the
standard.
to the process is prohibitively
standard will be applicable to a
(7) Whether the MRP "triggers" under the
expensive. Recent data submitted to the
workplace.
present standard are feasible; if not, what
agency indicates that the Bergsoe
Fourth, a new rulemaking will permit
triggers should be set.
furnace in fact may not be responsible
the agency to reassess the feasibility of
for the reduction in air lead levels
the medical removal protection
4. Effect of the Reconsideration on
attained in the Swedish facility. It now
provision (MRP). As discussed above,
Enforcement of the Present Standard
appears that the air lead reductions are
several industries have requested a one-
attributable to that facility's use of a
year suspension of the 60/40 MRP
Pending the reconsideration discussed
completely integrated ventilation
trigger because they predict that the
above, it is the agency's judgment that
system, and to meticulous housekeeping
trigger will compel the removal of large
the standard, as stayed by the Supreme
and work practices. These controls are
numbers of skilled trademen and will be
Court, should remain in effect and
much less expensive than the Bergsoe
extremely expensive: they also suggest
continue to be enforced. Specifically. all
process; however, it appears that the air
that these consequences may be due to
but the following provisions are in
lead levels achieved through their use is
the continuing stay of the engineering
effect:
somewhat higher than the 50 µg/m³ PEL.
control requirement of the standard.
(1) Section 1910.25(e) (1). (4). (5). (6). which
As with the new evidence concerning
Whether or not the one-year suspension
provide for compliance by engineering and
the innovative processes in the primary
is warranted if the present standard, as
work practice controls.
smelting industry, the agency believes it
stayed, continues in effect, (a question
(2) Section 1910.1025(e)(3). which governs
would be useful to subject this new data
which the agency is addressing
written compliance programs. except for
to public comment, and to obtain
separately), it is possible that if the PEL
paragraph (F).
(3) Section 1910.1025(f)(2)(ii). which relates
additional information if it exists.
is altered as a result of the new
to the use of respirators in situations in which
Third, a new rulemaking proceeding
rulemaking proceeding, the lower MRP
engineering and work practice controls are
will permit OSHA to evaluate whether
triggers may have to be adjusted as
not sufficient. During the period of this stay,
employees in industries such as
well. This is so because the feasibility of
employers shall provide a powered. air-
telecommunications and stevedoring,
MRP is keyed to the air lead levels
purifying respirator in lieu of the respirator
whose exposure to lead is asserted to be
present in the workplace. Accordingly,
specified in Table II of (f)(2)(i) when the
intermittent, face a "significant risk" of
the new rulemaking will address the
physical characteristics of the employee are
lead-related disease. Neither the
question of what adjustments if any,
such that the respirators specified in Table II
should be made to the MRP triggers. The
are inadequate for his or her protection. All
agency's statement of reasons to the
other sections of the regulation that refer to
original standard nor the court of
question of the agency's authority to
paragraph (f) shall incorporate only those
appeals' decision upholding the agency's
require MRP, however, will not be open
portions of (f) not stayed.
significant risk finding specifically
in the new proceeding.
(4) Section 1910.1025(i). governing hygiene
addressed this question. It is
Finally, at this stage of the proceeding,
facilities and practices, to the extent that it
undisputed, however, that the model
OSHA will accept and consider
requires the construction of new facilities or
correlating blood lead levels with the 50
suggestions as to the necessity for
substantial renovation of existing facilities.
µg/m³ level, upon which the
inquiring into other matters relevant to
(5) Sections 1910.1025 (j)(2) and (j)(3)(ii)(D)
agency's estimation of risk was
enforcement of the standard.
insofar as they require biological monitoring
and medical examination for zinc
premised. assumed that employees
3. Summary of Issues To Be Addressed
protoprohyrin: and Section 1910.1025(j)(3)(iii).
would be exposed for eight hours each
in the Proposed Rulemaking
which requires a multiple physician review
workday throughout the year. Although
mechanism.
OSHA does not believe that an industry-
In sum, OSHA invites comment on the
(6) Section 1910.1025(m), dealing with signs.
by-industry risk assessment is usually
propriety of conducting rulemaking on
(7) Section 1910.1025(r). startup dates. to
warranted, the fact that lead is excreted
the following issues:
the extent that its obligations are inconsistent
from the body upon removal from
with the substantive requirements of this
(1) Whether the PEL should be set at:
order.
exposure suggests that the risk
(a) 50 µg/m³ for engineering controls:
presented by highly intermittent
(b) 50 µg/m³ for any combination of
Protection for employees at risk must
exposure may be sufficiently different
controls including respirators;
be maintained because lead has long
from that presented by chronic exposure
(c) 100 µg/m³ for engineering controls.
been recognized as a major industrial
that separate treatment is appropriate
combined with 50 µg/m³ for respiratory
health hazard. During the past several
here. Therefore, in the new rulemaking
protection;
proceeding, OSHA intends to solicit
(d) 150 µg/m³ for engineering controls,
years, employers have been obligated to
combined with 50 µg/m³ for respiratory
bring most of the standard's protective
data on the extent of risk presented by
protection:
measures into place with the exception
highly intermittent exposure, and on the
(e) Any other level.
of the requirement to install engineering
extent of exposure which actually
(2) Whether compliance with any of the
controls, which has been judicially
occurs in the telecommunications and
above PELs is technologically and
stayed. There was general agreement
stevedoring industries. Any other
economically capable of being achieved; and
during the rulemaking and judicial
industries which believe they deserve
if so, in what time frame.
proceedings on the necessity of such
separate treatment on this basis should
(3) Whether highly intermittent exposure
provisions as respiratory usage, safe
submit data to the agency as well.
presents a significant risk of lead-related
OSHA also welcomes suggestions as to
disease. and if so. how intermittent exposure
work practices, and a medical
industries should be treated under the
surveillance program, although the
the manner in which intermittent
standard.
particulars may not have been resolved
exposure should be treated under the
(4) Whether a cost-benefit analysis can be
to the satisfaction of all affected
standard. e.g., by exempting the
performed for the lead standard: if so, how.
employers. The deferral of the next
22768
Federal Register / Vol. 46, No. 76 / Tuesday, April 21, 1981 / Proposed Rules
major step. engineering controls, means,
open top vapor degreasers, and
manufacturers and is available in the
however, that there is more than
conveyorized degreasers. Today's action
docket for public review and comment.
sufficient time for the agency to review
proposes to defer the applicability date
We expect this analysis to take
the provisions of the standard as a
of the proposed standards. The effect of
several months. Because the analysis is
whole and provide adequate notice if
today's action is to exempt from
not yet complete, we are not yet able to
changes to the standard seem
coverage any sources constructed or
specify which types of degreasers can
warranted. New effective dates may
modified on or before the new
comply with the proposed standards at
well be necessary in such a case.
applicability date is established. The
reasonable cost and which cannot. In
Consequently, there seems little
new date will be fixed later, by
the interim, however, many prudent
justification for disrupting the
publication of a notice in the Federal
purchasers of degreasers are willing to
compliance schedules and activities
Register.
buy only degreasers conforming to the
during this period of review. As
DATES: Comments on the amendment to
proposed standards. As a result,
discussed above, however, the agency is
the proposed rule must be received on or
manufacturers of degreasers which
separately addressing whether the
before May 21, 1981.
cannot comply with the proposed
effective date for the 60/40 MRP trigger
standards at reasonable cost face now
should be delayed.
ADDRESS: Comments should be
submitted (in duplicate if possible) to:
the competitive barrier they would have
Any comments and suggestions
should be sent to the address noted
Central Docket Section (A-130). U.S.
faced if the standards were promulgated
Environmental Protection Agency, 401 M
as proposed, despite the Agency's
above. Comments should be submitted
by June 1, 1981.
Street SW., Washington, D.C. 20460,
conclusion that application of the
Attention: Docket No. OAQPS-78-12.
proposed standards to at least some of
5. Authority
Docket. Docket No. OAQPS-78-12,
those products will not be required by
the/final standards.
This document was prepared under
containing supporting information used
the direction of Thorne G. Auchter,
in developing the proposed standards, is
Ordinarily, if EPA were to conclude
available for public inspection and
that the proposed standards would
Assistant Secretary of Labor for
copying between 8:00 a.m. and 4:00 p.m.,
impose unreasonable costs and that the
Occupational Safety and Health, 200
standards therefore should be
Constitution Avenue, NW., Washington,
Monday through Friday, at EPA's
D.C. 20210. It is issued pursuant to
Central Docket Section, West Tower
substantially changed, it would alleviate
section 6(b) of the Occupational Safety
Lobby, Gallery 1, Waterside Mall, 401 M
this situation promptly by proceeding to
and Health Act (84 Stat. 1593; 29 U.S.C.
Street SW., Washington, D.C. 20460. A
repropose or promulgate the standard
655).
reasonable fee may be charged for
with appropriate changes. Here,
however, we believe that the proposed
Signed at Washington. D.C., this 14th day
copying.
standards would impose unreasonable
of April 1981.
FOR FURTHER INFORMATION CONTACT:
cost for some degreasers, but are unable
Thorne G. Auchter,
Mr. John D. Crenshaw, Standards
to relieve the interim effects of the
Assistant Secretary of Labor.
Development Branch, Emission
proposal until technical analysis is
Standards and Engineering Division
(FR Doc. 81-11925 Filed 4-17-81: 12:03 pm)
complete. Under these circumstances,
BILLING CODE 4510-26-M
(MD-13), U.S. Environmental Protection
we believe that the action most
Agency, Research Triangle Park North
consistent with the congressional intent
Carolina 27711, telephone number (919)
is to defer the applicability date beyond
ENVIRONMENTAL PROTECTION
541-5421.
the date of proposal. See,
AGENCY
SUPPLEMENTARY INFORMATION: EPA
Commonwealth of Pennsylvania V. EPA,
proposed new source performance
618 F. 2d 991, 1000 n. 1. (3rd Cir. 1980).
40 CFR Part 60
standards for organic solvent cleaners
This action, therefore, amends
[AD-FBL-1799-3]
on June 11, 1980 (45 FR 39765). Under the
§ 60.360 of the proposed rule to delete
provisions of Section 111 of the Clean
June 11, 1980, (the date of the proposal)
Standards of Performance for New
Air Act, these standards. when finally
as the applicability date. The
Stationary Sources; Organic Solvent
promulgated. would have applied to any
promulgated standard will apply to
Cleaners
organic solvent cleaner manufactured
degreasers constructed or modified after
AGENCY: Environmental Protection
after June 11, 1980.
some later applicability date. The
Agency (EPA).
At proposal, the Agency concluded
Agency will give notice of that later
ACTION: Amendment of proposed rule.
that the cost impacts of the proposed
applicability date in the Federal
standards were reasonable. Based on
Register, and the applicability date will
SUMMARY: On June 11,1980, the
the public comments received, however,
be no earlier than the date of
Environmental Protection Agency (EPA)
we now believe that there are a number
publication of.such notice.
proposed standards of performance for
of types of degreasers which are
Under Executive Order 12291, EPA is
organic solvent cleaners (degreasers) (45
specifically designed to minimize
required to judge whether a regulation is
FR 39765). The proposed standards
solvent loss and emissions, but which
a "major rule" and therefore subject to
would limit emissions of volatile organic
could not comply with the proposed
certain requirements of the Order. The
compounds (VOC) and
design and equipment standards at
Agency has determined that this
trichloroethylene, perchloroethylene,
reasonable cost. Manufacturers of such
regulation would result in none of the
methylene chloride, 1,1,1-
degreasers would therefore be unable to
adverse economic effects set forth in
trichloroethane, and
cell them at competitive prices. We are
Section 1 of the Order as grounds for
trichlorotrifluoroethane from new,
now analyzing these types of degreasers
finding a regulation to be a "major rule."
modified. and reconstructed organic
to determine what constitutes best
In fact, this action would impose no
solvent cleaners by specifying a
demonstrated technology for them and
additional regulatory requirements, but
combination of equipment requirements
what standard should be applied to
instead would defer the effective date of
and operational procedures. The
them. Information about this problem
the standard in order to avoid adverse
affected facilities are cold cleaners,
has been supplied by several
economic impacts on manufacturers of
HHS NEWS
U.S. DEPARTMENT OF HEALTH AND human SERVICES
FOR IMMEDIATE RELEASE
Laura Genero - (202) 245-6343
Thursday, April 23, 1981
Secretary of Health and Human Services Richard S. Schweiker today announced
that FDA Commissioner Arthur Hull Hayes Jr. will conduct a complete review of
ways to provide health and safety information to consumers about drugs.
"Consumers need to be well informed about the risks and benefits of drugs
prescribed for them," Schweiker said. "We have an obligation to find the best
way to provide this important health and safety information."
The review will solicit the recommendations of consumers, health care pro-
fessionals, the pharmaceutical industry, independent expert groups and other
interested parties.
The review by Commissioner Hayes will attempt to:
--Determine whether the Patient Package Insert (PPIs) pilot program, as
previously developed is appropriately constructed to produce reliable data
on the effectiveness of PPIs;
--Consider alternative means of providing needed information to patients
about drugs prescribed for their use; and to
--Examine the cost-effectiveness of PPIs and other methods of providing drug
information to patients.
To permit this review, the FDA will postpone by Federal Register notice
the May 25 and July 2 effective dates of the pilot program requiring patient
package inserts for five new classes of drugs: cimetidine, clofibrate, propoxyphene,
ampicillin and phenytoin.
(More)
-2-
PPIs are already required for some classes of drugs, and there are no
plans to change this. These classes are oral contraceptives, estrogens and
progestins.
Preliminary estimates show that the pilot program, which would provide
120 million more PPIs to consumers, would cost an estimated $21 million, or
an average of 18 cents per new prescription which would be passed along to
the consumer.
# # #
DEPARTMENT OF EDUCATION
34 CFR Part 106
Office for Civil Rights
Nondiscrimination on the Basis of Sex in Education Programs
and Activities Receiving or Benefiting from Federal Financial
Assistance.
AGENCY: Department of Education.
ACTION: Notice of Proposed Rulemaking.
SUMMARY: The Secretary of Education proposes to amend the
Title IX regulations (nondiscrimination on the basis of sex)
by revoking a provision which prohibits discrimination in
the application of codes of personal appearance.
DATES: Comments must be received on or before [insert 30th day
after publication in the FEDERAL REGISTER.]
ADDRESSES: Comments should be addressed to Mr. Frederick T.
Cioffi, Acting Assistant Secretary for Civil Rights, 400
Maryland Avenue, S.W. (Room 5000, Switzer Building),
Washington, D.C. 20202.
FOR FURTHER INFORMATION CONTACT: Mr. Antonio J. Califa,
Telephone No. (202) 245-0843.
SUPPLEMENTARY INFORMATION: On December 11, 1978, the Department
of Health, Education, and Welfare (HEW) issued a notice proposing
the revocation of a subparagraph of the regulations implementing
Title IX of the Education Amendments of 1972. The subparagraph
proposed for revocation prohibits discrimination on the basis
of sex in rules relating to personal appearance (43 F.R. 58076).
The reasons given for that proposal were to permit issues
involving codes of personal appearance to be resolved at the
local level and to permit the Federal government to concentrate
its resources on the enforcement of other parts of the Title
IX regulations. That proposed rule was withdrawn on November 13,
1979 (44 F.R. 66626).
The Department of Education believes that there are sub-
stantial arguments that support the revocation of the provision
on appearance codes. The issue of sex discrimination in
codes of personal appearance, such as rules governing hair
length, is more properly resolved at the local level. Federal
regulations in this area are likely to be overly intrusive.
In addition, by freeing the Office for Civil Rights from
devoting its resources to resolving complaints involving
personal appearance codes, issues that are more clearly
related to the prohibition against sex discrimination under
Title IX can be given the additional attention they require.
As a result, the Department proposes to revoke subparagraph
(5) of paragraph (b) of 34 CFR 106.31, renumbering the
remainder of the section accordingly. Section 106.31 (b) (5)
presently reads as follows:
"(b) Specific prohibitions. Except as provided in this sub-
part, in providing any aid, benefit, or service to a student, a
recipient shall not, on the basis of sex:
* * *
(5) Discriminate against any person in the application of
any rules of appearance;"
Regulatory Flexibility Analysis
The regulation being amended affects all small entities
that are recipients of Federal financial assistance provided
by the Department of Education. Since the proposal involves
elimination of a requirement, there are no recordkeeping or
reporting burdens. If anything, the revocation of the rule
would lessen these burdens since the Department would no
longer investigate complaints related to rules of appearance.
Revocation of the rule is the alternative providing the
maximum reduction in burden on small entities.
Invitation to Comment
Interested persons are invited to submit comments and
recommendations regarding this proposed rulemaking. Written
comments and recommendations may be sent to the address given
at the beginning of this notice. All comments received on or
before the 30th day after publication of this document will
be considered. All comments submitted in response to this
notice will be available for public inspection, during and
after the comment period, in Room 5000, Switzer Building, 4th
and C Streets, S.W., Washington, D.C. between the hours of
8:30 a.m. and 4:00 p.m., Monday through Friday of each week,
except Federal holidays.
Dated:
H-16-81
MABLE
T. H. Bell
Secretary of Education
TOFRANK
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
STORE
WASHINGTON, D.C. 20503
April 17, 1981
File Req Reliev
MEMORANDUM FOR THE VICE PRESIDENT AND THE DIRECTOR
FROM:
Jim Miller
SUBJECT: Status Report on Regulatory Relief
Section 504 Legislation: Two major options for legislation
to alter handicap accessibility requirements for public
transit were developed by Task Force staff in coordination
with the Department of Transportation. Since the matter
raises a series of issues that transcend transportation, a
memorandum is being prepared for the Cabinet meeting next
week.
DOT Exemptions: Agreement was reached with DOT officials
regarding a limited exemption from the Executive Order for
certain routine Federal Aviation Administration, Coast
Guard, and other DOT regulations. (See Attachment 1.)
Office of Regulatory Impact Analysis: A presidential memorandum
establishing a temporary Office of Regulatory Impact Analysis
within OMB was drafted and forwarded to the White House
staff for review. This memorandum is a necessary step in
bringing the CWPS regulatory review staff permanently to
OMB. (See Attachment 2.)
Vice President's Meeting with Environmental Groups: On
Wednesday the Vice President met with representatives from
seven major environmental groups. (See Attachment 3.)
Postal Service: Following consultations with White House
and OMB officials, I sent a letter to Postmaster General
William Bolger asking the Postal Service to perform a
Regulatory Impact Analysis of the nine-digit ZIP code proposal.
(See Attachment 4.)
Attachments
PRESIDENT STATES UNITED
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
April 17, 1981
MEMORANDUM FOR: SECRETARY OF TRANSPORTATION
SUBJECT
: LIMITED EXEMPTION FROM EXECUTIVE ORDER 12291
By virtue of the authority vested in me under Executive Order
12291, and pursuant to discussions between our respective staffs,
I hereby exempt from Sections 3, 4, 7, and 8 of the Order the
following regulations when they are not major as defined in
Section 1 (b) of the Order:
A. ALL OFFICES OF THE DEPARTMENT OF TRANSPORTATION
1. Amendments to regulations that merely delay the
compliance dates of regulations already in effect.
B. COAST GUARD
1. Regatta regulations.
2. Safety zone regulations.
3. Security zone regulations.
C. FEDERAL AVIATION ADMINISTRATION
1. Standard instrument approach procedure regulations.
2. Enroute altitude regulations.
3. Routine air space actions.
4. Airworthiness directives.
OMB retains the right to designate as major any of the
regulations exempted by this memorandum under the Order.
This limited exemption expires automatically one year hence.
David A. Stockman
Director
MEMORANDUM FOR:
David A. Stockman
SUBJECT
:
ESTABLISHMENT OF THE OFFICE OF REGULATORY
IMPACT ANALYSES
Effective June 5, 1981 there is established within the Office
of Management and Budget a unit designated as the "Office of
Regulatory Impact Analyses." This unit shall report to the
Administrator for Information and Regulatory Affairs.
In addition to the Office Director, the Office shall be
staffed by not more than 20 employees. The function of the
Office shall be to perform those functions relating to the
regulatory impact analysis under Executive Order No. 12291
which are essential to the initial implementation of the
President's regulatory review program. In particular, the
Office shall, subject to the direction of the Director of the
Office of Management and Budget and the Administrator for
Information and Regulatory Affairs, be responsible for those
regulatory impact analysis functions set forth in Sections
3 (e) (1), 5, and 6 (a) (6) of Executive Order No. 12291.
This Office shall terminate on March 1, 1982, or at such time
as two or more of the cited Executive Order functions shall
be revoked, whichever is sooner. Upon termination of the
Office, if there are any continuing regulatory impact analysis
functions they shall be assumed by the Office of Information
and Regulatory Affairs or left to the agencies to perform
under reduced OMB guidance.
The authority of this memorandum expires on March 1, 1982.
Ronald Reagan
THE WHITE HOUSE
April , 1981
MEMORANDUM
OFFICE OF THE VICE PRESIDENT
WASHINGTON
April 14, 1981
MEMORANDUM TO THE VICE PRESIDENT
FROM:
C. Boyden Gray CBG
RE:
Meeting with Environmental Groups -- April 15, 1981
Attached is a description of each of the environmental
groups represented at tomorrow's meeting, and an outline of talking
points (with respect to which I could use 5-10 minutes briefing
prior to the meeting).
Attachments
DESCRIPTION OF ENVIRONMENTAL GROUPS
Adnan Dewind,
1. NRDC - Natural Resources Defense Council
Chairman
NRDC is the country's foremost environmental legal group.
It is widely respected by environmentalists and has been involved
in the majority of the major EPA cases.
NRDC has an annual budget of $4 million and employs some
35-40 lawyers and scientists in New York, Washington and
San Francisco. It is a 501 (c) (3) organization and thus devotes
some 20% of its time to lobbying. It has been an EPA watchdog.
Its other areas of interest include: air, anti-nuclear, forest
service, wetlands and barrier islands, international, and
mass transportation.
J. Clarence Davies, Ex. V.P.
2. Conservation Foundation
William Reilly, Pres.
The Conservation Foundation is a conservative environ-
mental think tank which emphasizes scientific research. It
is purely analytical and does no lobbying. Lately it has
specialized in large studies by groups representing a cross
section of industrial and public interests.
Dr. Jan Hair, Eyec. V.P
3. National Wildlife Federation
Mr. Thomas Kimball, past Exec
The National Wildlife Federation is the largest, most pros-
perous environmental organization and is generally regarded as
among the most conservative. It is composed of affiliated hunting
and fishing clubs and also has a national membership. Its Resources
Defense branch, composed of scientists and lawyers, has become
much more activist recently -- particularly in the energy area.
4. The Wilderness Society Charles M. Clusen, conservation Director
The Wilderness Society has undergone a renaissance of late,
having taken on former Senator Gaylord Nelson and former Congress-
man Joe Fisher. The Society is primarily involved in lobbying and
public education. It focuses on wilderness and public lands issues
with an emphasis on issues of importance in the West. Its staff
tends to be considerably more liberal and activist than its member-
ship.
5. The International Institute for Environment and Development
The Institute, formed by Barbara Ward, is not very well
known in the United States but is highly respected internationally.
It is a non-lobbying, analytical organization.
4 subassador
Robert Blate
2
6. The Sierra Club
John A. McComb wash. office
The Sierra Club was founded by David Brower and has
remained an activist and aggressive environmental organization.
While it tends to tilt heavily towards items of concern to
California and West coast environmentalists, it has a large
national membership with chapters in every state. It does a
lot of lobbying (it does not claim tax exempt status) and often
speaks for environmentalists on the Hill.
7. The World Wildlife Fund
Russell Grain, President
World Wildlife Fund -- which is headed by Russ Train --
is an organization concerned with wildlife protection in the
United States and abroad. It is involved predominantly in
fund raising and giving grants to projects designed to promote
and protect wildlife.
ENVIRONMENTALISTS -- TALKING POINTS
1. Input
a) We want to make sure all points of view are heard.
We've seen numerous industry, governmental and university groups at
their request, but no environmental groups have sought input.
b) Agencies will be making decisions, so make sure
your input is heard. We would rather work it out here and in Congress
than in the courts.
2. Task Force Goals -- Task Force goal is to achieve a
better balance between environmental concerns and economic growth.
We think more cost effective means can be found to protect environ-
mental concerns.
3. Substantive Programs -- No intention of eliminating
programs. We simply want to make them mesh better with each other
and work better by eliminating waste, conflict and duplication.
a) Clean Air Act -- Need to cut permitting delays,
strengthen scientific basis for standards, provide states greater
leeway, and get better understanding of Acid Rain.
b) Hazardous Waste Management -- EPA budget here
has been increased. Want to make it workable.
c) Superfund -- Intend to implement cost-effective
method for clean-up of emergency hazardous cites
d) Toxic Substances Control Act -- Want this law
to work with Clean Air Act and Clean Water Act to prevent public
health hazards.
4. Energy Development -- We must develop domestic
resources without sacrificing environmental or health concerns
protected by programs outlined above.
5. Foreign Competition -- In a global economy, do
not want to export jobs because other countries have met environ-
mental and health concerns in a more efficient way.
6. Adversary Relationships -- Much of the above depends
on avoiding adversary relationships and in developing better con-
census for striking the necessary balance.
EXECUTIVE OFFICE OF THE PRESIDENT
THE UNITED
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
April 10, 1981
Honorable William F. Bolger
Postmaster General
U.S. Postal Service
Washington, D.C. 20260
Dear Mr. Postmaster General:
As you know, serious questions have been raised about
the ramifications of the Postal Service's proposed 9-digit
zip code. In order to clear the air on this important
issue, I ask that your organization perform a Regulatory
Impact Analysis of the proposal in accordance with Section 3
of Executive Order 12291.
I wish to emphasize that this request does not in any
way imply our endorsement of the proposal or criticism of
it. We fully support actions by the Postal Service to
reduce costs and increase productivity. But I think a
thorough analysis of the proposal would contribute toward
achieving these objectives.
Sincerely yours,
James C. Miller III
Administrator for Information
and Regulatory Affairs
c: Senator Durenberger
Senator Jepsen
Congressman English