CONGRESSIONAL RECORD-HOUSE January 3, 1991

gression of jazz in the United States, and for

other purposes; and

S. 3016. An act for the relief of Janice and

Leslie Sedore and Ruth Hillman.

On November 6, 1990:

S. 1890. An act to amend title 5, United

States Code, to provide relief from certain

inequities remaining in the crediting of National Guard technician service in connection with civil service retirement, and for

other purposes;

S. 3043. An act for the relief of Nebraska

Aluminum Castings, Inc.; and

S. 3062. An act to transfer the responsibility for operation and maintenance of Highway 82 Bridge at Greenville, MS, to the

States of Mississippi and Arkansas.

On November 7, 1990:

S. 2516. An act to augment and improve the

quality of international data compiled by

the Bureau of Economic Analysis under the

International Investment and Trade in Services Survey Act by allowing that agency to

share statistical establishment list information compiled by the Bureau of the Census,

and for other purposes.

On November 8, 1990:

S. 580. An act to require institutions of

higher education receiving Federal financial

assistance to provide certain information

with respect to the graduation rates of student-athletes at such institutions;

S. 1756. An act to provide for the preservation and Interpretation of sites associated

with Acadian culture In the State of Maine;

and

S.J. Res. 375. Joint resolution to designate

October 30, 1990, as "Refugee Day."

On November 14, 1990:

S. 3156. An act to correct a clerical error in

Public Law 101-383.

On November 15, 1990:

S. 459. An act to amend title 35, United

States Code, with respect to the use of inventions in outer space;

S. 620. An act for the relief of Leroy W.

Shebal of North Pole, AK;

S. 639. An act to establish the Spark M.

Matsunaga Hydrogen Research, Development, and Demonstration Program Act of

1990;

S. 1630. An act to amend the Clean Air Act

to provide for attainment and maintenance

of health protective national ambient air

quality standards, and for other purposes;

S. 1805. An act to authorize the Secretary

of the Interior to reinstate oil and gas lease

LA 033164;

S. 1931. An act to amend title 11 of the

United States Code with respect to the

nondischargeability of debts arising from unlawful driving while intoxicated or impaired

and arising from restitution imposed for

committing crimes;

S. 2056. An act to establish a program of

grants for the development of State plans for

meeting the objectives established by the

Secretary of Health and Human Services for

the health status of the population of the

United States for the year 2000;

S. 2930. An act to eliminate "substantial

documentary evidence" requirement for

minimum wage determination for American

Samoa, and for other purposes;

S. 3187. An act to address Immediate problems affecting environmental cleanup activities;

S. 3215. An act to authorize the transfer by

lease of a specified naval landing ship dock

to the Government of Brazil;

S. 3237. An act to authorize the Secretary

of the Treasury to sell certain silver proof

coin sets;

S.J. Rles. 302. Joint resolution providing for

reappointment of Anne Legendre Armstrong

as a citizen regent of the Smithsonian Institution;

S.J. Res. 318. Joint resolution providing for

appointment of Ira Michael Heyman as a citizen regent of the Smithsonian Institution;

S.J. Res. 357. Joint resolution to designate

October 1-31, 1991, as "Community Center

Month"; and

S.J. Res. 369. Joint resolution designating

1991 as the "Year of Thanksgiving for the

Blessings of Liberty."

On November 16, 1990:

S. 169. An act to require the establishment

of a United States Global Change Research

Program aimed at understanding and responding to global change, including the cumulative effects of human activities and natural processes on the environment, to promote discussions toward international protocols in global change research, and for other

purposes;

S. 555. An act to establish in the Department of the Interior the De Soto Expedition

Trail Commission, and for other purposes;

S. 605. An act to authorize appropriations

for the Consumer Product Safety Commission, and for other purposes;

S. 677. An act to amend the Arctic Research and Policy Act of 1984 to improve and

clarify its provisions;

S. 1430. An act to enhance national and

community service, and for other purposes;

S. 2287. An act to authorize appropriations

to the National Aeronautics and Space Administration for research and development,

space flight, control and data communications, construction of facilities, and research

and program management, and for other purposes;

S. 2566. An act to establish the Smith River

National Recreation Area, to redesignate the

Sunset Crater National Monument, and for

other purposes;

S. 2789. An act to authorize appropriations

for the Earthquake Hazards Reduction Act of

1977, and for other purposes;

S. 2857. An act to amend the Public Health

Service Act with respect to certain programs

for the National Institutes of Health;

S. 2936. An act to amend the Hazardous Materials Transportation Act to authorize appropriations for fiscal years 1990, 1991, and

1992, and for other purposes;

S. 2946. An act to amend the Public Health

Service Act to revise and extend the program

establishing the National Bone Marrow

Donor Registry, and for other purposes;

S. 3069. An act to provide a method of locating private and Government research on

environmental issues by geographic location;

S. 3084. An act to provide for the settlement of water rights claims of the Fallon

Paiute Shoshone Indian Tribes and for other

purposes;

S. 3176. An act to promote environmental

education, and for other purposes; and

S.J. Res. 206. Joint resolution calling for

the United States to encourage immediate

negotiations toward a new agreement among

Antarctic Treaty Consultative Parties, for

the full protection of Antarctica as a global

ecological commons.

On November 28, 1990:

S. 319. An act to effect an exchange of

lands between the United States Forest

Service and the Salt Lake City Corporation

within the State of Utah, and for other purposes;

S. 566. An act to authorize a new HOME Investment Partnerships program, a National

Homeownership Trust program, and HOPE

programs, to amend and extend certain laws

relating to housing, community and neighborhood preservation, and related programs,

and for other purposes;

S. 845. An act to amend the Federal Food,

Drug, and Cosmetic Act to revitalize the

Food and Drug Administration, and for other

purposes;

S. 1859. An act to restructure repayment

terms and conditions for loans made by the

Secretary of the Interior to the Wolf Trap

Foundation for the Performing Arts for the

reconstruction of the Filene Center in Wolf

Trap Farm Park in Fairfax County, VA, and

for other purposes;

S. 1893. An act to reauthorize the Asbestos

School Hazard Abatement Act of 1984;

S. 1939. An act to extend the authorization

of appropriations for the Taft Institute;

S. 2628. An act to amend the Public Health

Service Act to reauthorize certain National

Institute of Mental Health grants and to improve provisions concerning the State com- prehensive mental health services plan, and

for other purposes;

S. 2740. An act to provide for the conservation and development of water and related

resources, to authorize the United States

Army Corps of Engineers civil works program to construct various projects for improvements to the Nation's infrastructure,

and for other purposes;

S. 2830. An act to extend and revise agri- cultural price support and related programs,

to provide for agricultural export, resource conservation, farm credit, and agricultural

research and related programs, to ensure consumers an abundance of food and fiber at

reasonable prices, and for other purposes;

S. 3012. An act to amend the Independent

Safety Board Act of 1974 to authorize appropriations for fiscal years 1991, 1992, and 1993,

and for other purposes;

S.J. Res. 329. Joint resolution to designate

the week of November 3, 1990, to November

10, 1990, as "National Week to Commemorate

the Victims of the Famine in the Ukraine,

1932-1933", and to commemorate the Ukrainian famine of 1932-1933 and the policies of

Russification to suppress Ukrainian identify;

and

S.J. Res. 364. Joint resolution to designate

the third week of February 1991 as "National

Parents and Teachers Association Week."

On November 29, 1990:

S. 303. An act to establish a framework for

the conduct of negotiated rulemaking by

Federal agencies;

S. 358. An act to amend the Immigration

and Nationality Act to change the level, and

preference system for admission, of immigrants to the United States, and to provide

for administrative naturalization, and for

other purposes; and

S. 3266. An act to control crime.

BILLS DISAPPROVED AFTER SINE

DIE ADJOURNMENT

The President announced his disapproval of the following bills with

memorandums of disapproval as follows:

H.R. 4638-MEMORANDUM OF DISAPPROVAL

I am withholding my approval of H.R. 4638,

the "Orphan Drug Amendments of 1990."

This legislation would make substantive

changes to the orphan drug provisions of the

Federal Food, Drug, and Cosmetic Act and

the Orphan Drug Act.

Enacted in 1983, the Orphan Drug Act cre- ated economic incentives for drug companies

to develop drugs for rare diseases and conditions-so-called "orphan drugs." Typically,

these drugs would not be profitable to develop because of their small patient populations.

116
January 3, 1991 CONGRESSIONAL RECORD-HOUSE

By any measure, the Orphan Drug Act has

been a tremendous success. A total of 49 new

drugs for rare diseases have been approved

under this program, and 370 others are in the

development stage. These drugs have provided lifesaving treatments for such terrible

disease as enzyme deficiency, which affects

adversely the immune system of about 40

children nationwide. Until the orphan drug was developed to treat these children, they

had to spend their entire lives in the protection of an isolation bubble. One of the first

orphan drugs is another example of a triumph. The most difficult form of leprosy affects only 4,000 people. A drug known for over 14 years to be effective in treating this

condition was not being marketed by any

drug company, because it was considered unprofitable--until the Orphan Drug Act provided the marketing incentive. In a similar

manner, orphan drugs provide treatment for

terrible diseases for which there is usually no alternative therapy.

I have serious concerns about the effect

the H.R. 4638 would have upon the incentive

of drug companies to develop orphan drugs. I

believe we must not endanger the success of

this program, which is due to large measure to the existence of the "market exclusivity"

provision in the Orphan Drug Act that allows

companies to have exclusive marketing

rights to an orphan drug for 7 years. Weakening the current 7-year exclusivity provision

would certainly discourage development of

desperately needed new orphan drugs.

Under current law, firms may apply to develop the same orphan drug, but only the

first firm to have its drug approved receives

market exclusivity. The certainty of this 7-

year period is the basis of the economic incentive to attract drug firms to invest in orphan drugs.

The bill would make two major changes to

the market exclusivity provisions of the Orphan Drug Act. First, the bill provides for

"shared exclusivity." Firms that can demonstrate that they have developed the or- phan drug simultaneously would be allowed

to -share the market with the firm initially

awarded the market exclusivity. Second, the

bill requires the Food and Drug Administration to withdraw the marketing exclusivity

as soon as the patient population exceeds a 200,000 patient limit. Both of these changes

have the effect of weakening the marketing

incentives provided by the Act. Under the

bill, the length of the market exclusivity period will depend on how quickly the patient

population grows and whether other firms

file claims for simultaneous development.

In addition, as currently constructed, the

200,000 patient population limit would be applied to orphan drugs approved prior to the

enactment of the bill as well as to those approved in the future. This retroactive rule

change would send a troublesome signal to

all those who might wish to develop orphan

drugs that the Federal Government may

change unilaterally the rules for firms that

made investment decisions based on the expectation of 7 years of market exclusivity.

I am aware that this bill was passed after a number of compromises among Members of

Congress. I am extremely concerned, however, that individuals with rare diseases may

suffer because of changes that this bill would

make in the incentives to develop new drug

treatment. Accordingly, I am withholding

my approval of H.R. 4638.

GEORGE BUSH.

THE WHITE HOUSE, November 8, 1990.

H.R. 4653-MEMORANDUM OF DISAPPROVAL

I am withholding my approval of H.R. 4653,

the "Omnibus Export Amendments Act of

1990." Although this legislation contains

constructive provisions, it would severely

constrain Presidential authority in carrying

out foreign policy.

I agree with the principal goals of this bill,

which include improved export controls for,

and sanctions against the use of, chemical

and biological weapons; sanctions on Iraq;

missile technology sanctions; and reauthorization of the Export Administration Act. Indeed, I have recently signed into law provisions on missile technology sanctions and

sanctions against Iraq comparable to those

contained in this bill. H.R. 4653, however,

contains elements that I be,leve would undermine these objectives and our ability to

act quickly, decisively, and multilaterally at

a time when we must be able t) do so. These

provisions unduly interfere wih the President's constitutional responsibilities for carrying out foreign policy. Rather than sigrirg

the bill, I am directing action under existing

authorities to accomplish the bill's principal

goals.

I am pleased that the Congress endorses

my goal of stemming the dangerous proliferation of chemical and biological weapons. The Administration has worked closely

with the Congress to design appropriate and

effective legislation to improve our ability

to impose sanctions on the nations that use

such weapons and any companies that contribute to their spread. Indeed, the Administration supported the House version of the

sanctions provision. Throughout discussions

with the Congress, my Administration insisted that any such legislation should not

harm cooperation with our partners and

should respect the President's constitutional

responsibilities. Unfortunately, as reported

from conference, H.R. 4653 does not safeguard

those responsibilities, nor does it meet our broader foreign policy goals.

The major flaw in H.R. 4653 is not the requirement of sanctions, but the rigid way in

which they are imposed. The mandatory imposition of unilateral sanctions as provided

in this bill would harm U.S. economic interests and provoke friendly countries who are

essential to our efforts to resist Iraqi aggression. If there is one lesson we have all

learned in Operation Desert Shield, it is that

multilateral support enhances the effectiveness of sanctions.

Because of my deep concern about the serious threat posed by chemical and biological

weapons, I have signed an Executive order

directing the imposition of the sanctions

contained i;, this bill and implementing new

chemical and biological weapon export controls. This Executive order goes beyond H.R.

4653 in some respects. It sets forth a clear set

of stringent sanctions, while encouraging negotiations with our friends and allies. It Imposes an economic penalty on companies

that contribute to the spread of these weapons and on countries that actually use such

weapons or are making preparations to do

so. At the same time, it allows the President

necessary flexibility in implementing these

sanctions and penalties. Furthermore, the

Executive order reaffirms my determination

to achieve early conclusion of a verifiable

global convention to prevent the production

and use of chemical weapons.

The Executive order also directs the establishment of enhanced proliferation controls,

carefully targeted on exports, projects, and

countries of concern. On this issue, as with

other important export control matters, my

goal is to pursue effective, multilateral export controls that send the clear message

that the United States will not tolerate violations of international law.

I am also concerned that other features of

H.R. 4653 would hamper our efforts to improve the effectiveness of export controls. In

the rapidly changing situation in Eastern

Europe, and in bilateral relationships with

the Soviet Union, we have demonstrated the

ability to adjust, in cooperation with our allies, export controls on high technology to

reflect the new strategic relationships. Last

May I asked our allies to liberalize dramatically our multilateral export controls. Negotiations designed to liberalize trade to encourage democratic institutions and open

market economies will continue. Our multilateral export controls have contributed significantly to the positive changes brought

about in West-East relations. The

micromanagement of export controls mandated by H.R. 4653 can only damage these on- going effortu.

In other areas, H.R. 4653 would be harmful

to closely linked U.S. economic and foreign

policy interests. For example, under section

128 of the bill there would be extraterritorial

application of U.S. law that could force foreign subsidiaries of U.S. firms to choose between violating U.S. or host country laws.

Other sections of H.R. 4653 contain useful

provisions that will be implemented as soon as possible. However, additional legal au- thority is not required to make our export

control system reflect the economic and na- tional security realities of today's world, In

response to recent world events, I am directing Executive departments and agencies to

implement the following changes:

-By June 1, 1991, the United States will

eliminate all dual-use export licenses

under section 5 of the Export Administration Act to members of the export

control group known as CoCom, consistent with multilateral arrangements. In

addition, all re-export licenses under sec- tion 5 to and from CoCom will be eliminated, consisent with multilateral arrangements.

-By June 1, 1991, the United States will re- move from the U.S. munitions list all

items contained on the CoCom dual-use

list unless significant U.S. national secu- rity interests would be jeopardized.

-By January 1, 1991, U.S. review of export

licenses subject to CoCom Favorable

Consideration and National Discretion

procedures will be reduced to 30 and 15

days, respectively.

-By January 1, 1991, new interagency procedures will be instituted to make dual- use export license decisions more predictable and timely.

-By January 1, 1991, the Secretary of

State will initiate negotiations to ensure that supercomputer export controls are multilateral in nature and not undermined by the policies of other supplier

countries.

-By June 1, 1991, in consultation with industry, we will devise and publish a method to index supercomputer license

conditions to reflect rapid advances in

the industry and changes in strategic concerns. -By January 1, 1991, we will significantly

increase the threshold for Distribution

Licenses to free world destinations and ensure that at least annually these

thresholds are adjusted to reflect

changes in technology and are consistent

with international relationships, including changing requirements to stem the

proliferation of missile technology and

117