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STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
(Senate - June 05, 1997)
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STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. JEFFORDS:
S. 830. A bill to amend the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act to improve the regulation of food, drugs,
devices, and biological products, and for other purposes; to the
Committee on Labor and Human Resources.
the food and drug administration modernization and accountability act
of 1997
Mr. JEFFORDS. Mr. President, today I am introducing legislation to
modernize the Food and Drug Administration [FDA] and reauthorize the
Prescription Drug User Fee Act for 5 years. This legislation comes as
result of over 3 years of consideration by the Congress on steps that
could be taken by the agency that would contribute to its mandate to
protect the American public while ensuring that life-saving products
could be made more readily available.
FDA acknowledges that its mandate also requires it to regulate over
one-third of our Nation's products. Within its purview the FDA
regulates virtually all of the food and all of the cosmetics, medical
devices, and drugs made available to our citizens. I believe, and
several members of the Labor Committee share my belief, that in an
organization the size of FDA there is always room for improvement and
modernization. Our objective, which this legislation achieves, was
identify areas where improvements could be made that will strengthen
the agency's ability to approve safe and effective products more
expeditiously.
Last year, both the House and the Senate held numerous and extensive
hearings on countless proposals for modernizing and reforming the FDA.
The Senate Labor and Human Resources Committee successfully reported a
bipartisan bill that sought to accomplish many of those reforms. But
last year, acrimonious issues remained, time ran out and the bill did
not receive floor consideration. This year I have resolved to move
forward. I have been committed to addressing last year's most
controversial issues. I believe that the legislation I am introducing
today addresses virtually all of objections raised last year both in
process and in content. This is a better bill and I believe that upon
examination, my colleagues will agree that it accomplishes its goal.
I want to comment a moment on the open, consensus-building process we
followed in developing this legislation. The Labor Committee held two
hearings. During the first the committee received testimony from the
principal FDA Deputy Commissioner, Dr. Michael Friedman, and all of the
FDA Center Directors. The second hearing included representatives from
patient and consumer coalitions and from the food, drug, and medical
device sectors regulated by the FDA. Committee members learned from the
agency of the administrative reforms and the progress it has already
undertaken, areas that remain a challenge, and those areas that require
legislative authority to change. The committee listened to consumers'
concerns with provisions that were considered last year that they felt
would weaken the FDA's ability to protect the public health. Finally,
the committee learned of the ongoing and needless delays and
frustrations facing health care and consumer product sectors of our
economy in working with the FDA. The committee learned of the
frustrated attempts to work through the bureaucratic labyrinth of
needless regulatory delays. Delays that prohibited people from getting
access to vitally needed, life saving medical treatments, drugs, and
devices.
Since the finish of the committee's hearings we have engaged in an
open, collaborative process that has given voice to each party wishing
to be heard. For many of these meetings it is worth noting that the
agency was a full, cooperating participant and we would not have been
able to make the progress made without FDA's collaboration. Several
meetings, essentially roundtable discussions, have occurred with
bipartisan committee staff, the FDA, and each of the several sectors
regulated by the agency. These meetings have given all the participants
an opportunity to discuss problems and potential solutions and have
been the basis for the consensus bill I am introducing today. Finally,
committee staff have had numerous meetings to discuss key provisions in
the bill with a wide range of consumer groups including, among others,
the Patient Coalition, Public Citizen, the Centers for Science in the
Public Interest, the Pediatric AIDS Foundation, and the National
Organization for Rare Diseases. It should be clear that no person or
group was excluded from this deliberative process.
Let me turn to the content of this measure and the steps we have
taken to respond to the controversies raised last year. Five key
objections were raised against the FDA reform bill that had been
reported on a strong bipartisan vote from the Labor and Human Resources
Committee during the last Congress. In that vein, we have sought to and
have accomplished addressing each of the substantive concerns raised by
the minority.
Last year's measure was criticized by some for the number of
mandatory, but shortened, product review time frames that critics said
would overburden the FDA and for the hammers that would have required
FDA to contract out some product reviews or to give priority to
products approved abroad. Today's legislation eliminates most of the
mandatory time frames and retains only those necessary to ensure
collaborative, more efficient reviews or to facilitate quick reviews of
low risk products. The contracting out and European review hammers that
would have forced FDA actions have been eliminated.
Last year's provision allowing for third party, outside expert review
were criticized for turning central regulatory authority decisions over
to private industry, creating conflicts of interest, and depriving FDA
of resources and expertise. Today's legislation adopts FDA's current
system for accrediting and selecting third-party review organizations.
The bill expands FDA's current pilot third-party review program beyond
just the lowest risk devices and FDA retains final approval for all
devices. Devices that are life-
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supporting, life-sustaining, or implantable are excluded from third-
party review. FDA may allow third-party review for higher risk devices
at its sole discretion. This approval will allow FDA to retain,
augment, and focus its expertise, at its discretion, on critical areas
of its expanding workload.
Last year's bill would have required FDA to contract out review of
food additive petitions, medical devices, and drugs. Critics argued
these changes would weaken consumer protections. We have modified these
provisions to give FDA express authority to contract out when deemed by
FDA to be more efficient or to add needed expertise.
Thsi year the collaborative effort has continued. During our meetings
FDA identified a number of enforcement powers that the agency believes
will enhance its ability to protect the public health. We have included
a number of FDA's specific requests. Many patient and consumer groups
raised concerns about insufficient safeguards related to the fast-track
drug approval process and the provision improving accelerated access to
investigational products and we have adopted several of their key
concerns.
I would close by saying that this measure embodies a reasonable,
moderate approach to balancing the agency's mandate to regulate over
one-third of our Nation's economy and provide for the public health and
safety with the compelling need to provide new, improved, safe, and
effective products to the American public. It is a good bill and I look
forward to working with my colleagues to improve it even further.
______
By Mr. SHELBY (for himself, Mr. Bond, Mr. Hagel, Mr. Hutchinson,
and Mr. Coverdell):
S. 831. A bill to amend chapter 8 of title 5, United States Code, to
provide for congressional review of any rule promulgated by the
Internal Revenue Service that increases Federal revenue, and for other
purposes; to the Committee on Governmental Affairs.
the stealth tax prevention act
Mr. SHELBY. Mr. President, I rise today to introduce the Stealth Tax
Prevention Act. Perhaps the most important power given to the Congress
in the Constitution of the United States is bestowed in article I,
section 8--the power to tax. This authority is vested in Congress
because, as elected representatives, Congress remains accountable to
the public when they lay and collect taxes.
Last year, Mr. President, Congress passed the Congressional Review
Act of 1996, which provides that when a major agency rule takes effect,
Congress has 60 days to review it. During this time period, Congress
has the option to pass a disapproval resolution. If no such resolution
is passed, the rule then goes into effect.
The Internal Revenue Service, as the President here knows, has
enormous power to affect the lives and the livelihoods of American
taxpayers through their authority to interpret the Tax Code. The
Stealth Tax Prevention Act that I am introducing today, along with
Senator Bond and Senator Hagel, will expand the definition of a major
rule to include, Mr. President, any IRS regulation which increases
Federal revenue. Why? Because we desperately need this today.
For example, if the Office of Management and Budget finds that the
implementation and enforcement of a rule has resulted in an increase of
Federal revenues over current practices or revenues anticipated from
the rule on the date of the enactment of the statute under which the
rule is promulgated. Therefore, the Stealth Tax Prevention Act will
allow Congress to review the regulation and take appropriate measures
to avoid raising taxes on hard-working Americans, in most cases, small
businesses.
Mr. President, the Founding Fathers' intent, as you know, was to put
the power to lay and collect taxes in the hands of elected Members of
Congress, not in the hands of bureaucrats who are shielded from public
accountability. It is appropriate, I believe, that the IRS's breach of
authority is addressed, in light of the fact that we are celebrating
this week Small Business Week.
The discretionary authority of the Internal Revenue Service exposes
small businesses, farmers, and others to the arbitrary whims of
bureaucrats, thus creating an uncertain and, under certain cases,
hostile environment in which to conduct day-to-day activities. Most of
these people do not have lobbyists that work for them, other than their
elected Representatives, the way it should be. The Stealth Tax
Prevention Act will be particularly helpful in lowering the tax burden
on small business which suffers disproportionately, Mr. President, from
IRS regulations. This burden discourages the startup of new firms and
ultimately the creation of new jobs in the economy, which has really
made America great today.
Americans pay Federal income taxes. They, Mr. President, as you well
know, pay State income taxes. They pay property taxes. On the way to
work in the morning they pay a gasoline tax when they fill up their
car, and a sales tax when they buy a cup of coffee.
Mr. President, average Americans in small businesses are saddled with
the highest tax burden in our country's history.
Allowing bureaucrats to increase taxes even further, at their own
discretion through interpretation of the Tax Code is intolerable. The
Stealth Tax Prevention Act will leave tax policy where it belongs, to
elected Members of the Congress, not unelected and unaccountable IRS
bureaucrats.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 831
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. CONGRESSIONAL REVIEW OF INTERNAL REVENUE SERVICE
RULES THAT INCREASE REVENUE.
(a) Short Title.--This Act may be cited as the ``Stealth
Tax Prevention Act''.
(b) In General.--Section 804(2) of title 5, United States
Code, is amended to read as follows:
``(2) The term `major rule'--
``(A) means any rule that--
``(i) the Administrator of the Office of Information and
Regulatory Affairs of the Office of Management and Budget
finds has resulted in or is likely to result in--
``(I) an annual effect on the economy of $100,000,000 or
more;
``(II) a major increase in costs or prices for consumers,
individual industries, Federal, State, or local government
agencies, or geographic regions; or
``(III) significant adverse effects on competition,
employment, investment, productivity, innovation, or on the
ability of United States-based enterprises to compete with
foreign-based enterprises in domestic and export markets; or
``(ii)(I) is promulgated by the Internal Revenue Service;
and
``(II) the Administrator of the Office of Information and
Regulatory Affairs of the Office of Management and Budget
finds that the implementation and enforcement of the rule has
resulted in or is likely to result in any net increase in
Federal revenues over current practices in tax collection or
revenues anticipated from the rule on the date of the
enactment of the statute under which the rule is promulgated;
and
``(B) does not include any rule promulgated under the
Telecommunications Act of 1996 and the amendments made by
that Act.''.
Mr. BOND. Mr. President, I rise today to join my distinguished
colleague from Alabama, Senator Shelby, in introducing legislation to
ensure that the Treasury Department's Internal Revenue Service does not
usurp the power to tax--a power solely vested in Congress by the U.S.
Constitution. The Stealth Tax Prevention Act will ensure that the duly
elected representatives of the people, who are accountable to the
electorate for our actions, will have discretion to exercise the power
to tax. This legislation is intended to curb the ability of the
Treasury Department to bypass Congress by proposing a tax increase
without the authorization or consent of Congress.
The Stealth Tax Prevention Act builds on legislation passed
unanimously by the Senate just over 1 year ago. As chairman of the
Committee on Small Business, I authored the Small Business Regulatory
Enforcement Fairness Act--better known as the Red Tape Reduction Act--
to ensure that small businesses are treated fairly in agency rulemaking
and enforcement activities. Subtitle E of the Red Tape Reduction Act
provides that a final rule issued by a Federal agency and deemed a
major rule by the Office of Information and Regulatory Affairs of the
Office of Management and Budget
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cannot go into effect for at least 60 days. This delay is to provide
Congress with a window during which it can review the rule and its
impact, allowing time for Congress to consider whether a resolution of
disapproval should be enacted to strike down the regulation. To become
effective, the resolution must pass both the House and Senate and be
signed into law by the President or enacted as the result of a veto
override.
The bill Senator Shelby and I introduce today amends this law to
provide that any rule issued by the Treasury Department's Internal
Revenue Service that will result in a tax increase--any increase--will
be deemed a major rule by OIRA and, consequently, not go into effect
for at least 60 days. This procedural safeguard will ensure that the
Department of the Treasury and its Internal Revenue Service cannot make
an end-run around Congress, as it is currently attempting with the
stealth tax it proposed on January 13.
As my colleagues are aware, the IRS has issued a proposal that is
tantamount to a tax increase on businesses structured as limited
liability companies. The IRS proposal disqualifies a taxpayer from
being considered as a limited partner if he or she ``participates in
the partnership's trade or business for more than 500 hours during a
taxable year'' or is involved in a ``service'' partnership, such as
lawyers, accountants, engineers, architects, and health-care providers.
The IRS alleges that its proposal merely interprets section
1402(a)(13) of the Tax Code, providing clarification, when in actuality
it is a tax increase by regulatory fiat. Under the IRS proposal,
disqualification as a limited partner will result in a tax increase on
income from both capital investments as well as earnings of the
partnership. The effect will be to add the self-employment tax--12.4
percent for social security and 2.9 percent for Medicare--to income
from investments as well as earnings for limited partners that under
current rules can exclude such income from the self-employment tax.
Under the bill introduced today, the tax increase proposed by the
Internal Revenue Service of the Treasury Department, if later issued as
a final rule, could not go into effect for at least 60 days following
its publication in the Federal Register. This window, which coincides
with issuance of a report by the Comptroller General, would allow
Congress the opportunity to review the rule and vote on a resolution to
disapprove the tax increase before it is applied to a single taxpayer.
The Stealth Tax Prevention Act strengthens the Red Tape Reduction Act
and the vital procedural safeguards it provides to ensure that small
businesses are not burdened unnecessarily by new Federal regulations.
Congress enacted the 1966 provisions to strengthen the effectiveness of
the Regulatory Flexibility Act, a law which had been ignored too often
by Government agencies, especially the Internal Revenue Service. Three
of the top recommendations of the 1995 White House Conference on Small
Business sought reforms to the way Government regulations are developed
and enforced, and the Red Tape Reduction Act passed the Senate without
a single dissenting vote on its way to being signed into law last year.
Despite the inclusion of language in the 1996 amendments that expressly
addresses coverage of IRS interpretative rules, we find ourselves faced
again with an IRS proposal that was not issued in compliance with the
Regulatory Flexibility Act.
As 18 of my Senate colleagues and I advised Secretary Rubin in an
April letter, the proposed IRS regulation on limited partner taxation
is precisely the type of rule for which a regulatory flexibility
analysis should be done. Although, on its face, the rulemaking seeks
merely to define a limited partner or to eliminate uncertainty in
determining net earnings from self-employment, the real effect of the
rule would be to raise taxes by executive fiat and expand substantially
the spirit and letter of the underlying statute. The rule also seeks to
impose on small businesses a burdensome new recordkeeping and
collection of information requirement that would affect millions of
limited partners and members of limited liability companies. The
Treasury's IRS proposes this stealth tax increase with the knowledge
that Congress declined to adopt a similar tax increase in the Health
Security Act proposed in 1994--a provision that the Congressional Joint
Committee on Taxation estimated in 1994 would have resulted in a tax
increase of approximately $500 million per year.
The Stealth Tax Prevention Act would remove any incentive for the
Treasury Department to underestimate the cost imposed by an IRS
proposed or final rule in an effort to skirt the administration's
regulatory review process or its obligations under the Regulatory
Flexibility Act. By amending the definition of major rule under the
Congressional Review Act, which is subtitle E of the Red Tape Reduction
Act, we ensure that an IRS rule that imposes a tax increase will be a
major rule, whether or not it has an estimated annual effect on the
economy of $100,000,000. Our amendment does not change the trigger for
a regulatory flexibility analysis, which still will be required if a
proposed rule would have a significant economic impact on a substantial
number of small entities. We believe the heightened scrutiny of IRS
regulations called for by this legislation will provide an additional
incentive for the Treasury Department's Internal Revenue Service to
meet all of its procedural obligations under the Regulatory Flexibility
Act and the Red Tape Reduction Act.
I urge my colleagues to join Senator Shelby and me in supporting this
important legislation to ensure that the IRS not usurp the proper role
of Congress--nor skirt its obligations to identify the impact of its
proposed and final rules. Rules such as that currently proposed by the
IRS should be carefully scrutinized by Congress. When the Department of
the Treasury issues a final IRS rule that increases taxes, Congress
should have the ability to exercise its discretion to enact a
resolution of disapproval before the rule is applicable to a single
taxpayer. The Stealth Tax Prevention Act Senator Shelby and I introduce
today provides that opportunity.
______
By Mr. KOHL (for himself, Mr. Kerrey, Mr. Harkin, Mr. Hatch, Mr.
Hagel, and Mr. Grassley):
S. 832. A bill to amend the Internal Revenue Code of 1986 to increase
the deductibility of business meal expenses for individuals who are
subject to Federal limitations on hours of service; to the Committee on
Finance.
The Business Meal Deduction Fairness Act of 1997
Mr. KOHL. Mr. President, as my colleagues know, I am one of this
body's strongest advocates for deficit reduction. I attribute much of
my deep commitment to this goal to my days in business. As a
businessman, I learned that you must balance your books and live within
your means. I also learned that you must treat people fairly and admit
when you have made a mistake. I have come to the floor to acknowledge
that a mistake has been made, and must be corrected.
In August 1993 we passed the omnibus budget reconciliation bill. I am
proud to say that this legislation has helped to produce falling
deficits and sustained economic growth. However, in our efforts to get
our fiscal house in order we unfairly penalized a group of hard
working, middle-class Americans: transportation workers. It is for this
reason that I rise today, to reintroduce the business meal deduction
fairness bill. This measure would increase the deductibility of
business meals, from 50 to 80 percent, for individuals who are required
to eat away from home due to the nature of their work.
In the 1993 reconciliation bill was a provision which lowered the
deductible portion of business meals and entertainment expenses from 80
to 50 percent. The change was aimed at the so-called three martini
lunches and extravagant entertainment expenses of Wall Street
financiers and Hollywood movie moguls. Unfortunately, the change also
hit the average truck driver who eats chicken fried steak, hot roast
beef sandwiches, and meatloaf in truck stops. And while those who
entertain for business purposes can change their practices based on the
tax law change, long-haul transportation workers often have no choice
but to eat on the road.
For these workers, the 1993 decrease in the meal deduction has
translated into an undeserved decrease in take home pay. For example,
when the allowable deduction was dropped in 1993,
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it increased taxes on an average truck driver $700 to $2,000 per year.
This is a huge increase for a truck driver who normally earns $27,000
to $35,000 per year.
Our legislation would increase the take-home pay of hard working,
middle-class Americans who were inadvertently hurt by changes in the
tax law in 1993. Workers who, due to regulations limiting travel hours,
must eat out. They have no control over the length of their trips, the
amount of time they must rest during a delivery, or, in many cases, the
places they can stop and eat. This legislation is straight forward. It
would simply restore the business meal expense deduction to 80 per cent
for individuals subject to the Department of Transportation's hours-of-
service limitations.
I will be the first to admit that the budget deficit is the No. 1
economic problem facing this country. Since being elected to the
Senate, I have fought to eliminate this destructive drain on our
ability to grow and compete in the world economy, but I have fought to
do so in a fair manner. The 1993 reconciliation bill closed a loophole
and unintentionally trapped some very hard working Americans. We need
to acknowledge that a mistake was made and take the opportunity of a
tax bill moving this year to fix that mistake. Therefore my colleagues,
Senators Kerrey, Harkin, Hatch, Hagel, Grassley and I are requesting
the support and assistance of this entire body to ensure that the
business meal deduction fairness bill becomes law. Mr. President, I ask
unanimous consent that a copy of my legislation be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 832
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. INCREASED DEDUCTIBILITY OF BUSINESS MEAL EXPENSES
FOR INDIVIDUALS SUBJECT TO FEDERAL LIMITATIONS
ON HOURS OF SERVICE.
(a) In General.--Section 274(n) of the Internal Revenue
Code of 1986 (relating to only 50 percent of meal and
entertainment expenses allowed as deduction) is amended by
adding at the end the following new paragraph:
``(3) Special rule for individuals subject to federal
limitations on hours of service.--In the case of any expenses
for food or beverages consumed by an individual during, or
incident to, any period of duty which is subject to the hours
of service limitations of the Department of Transportation,
paragraph (1) shall be applied by substituting `80 percent'
for `50 percent'.''
(b) Effective Date.--The amendment made by subsection (a)
shall apply to taxable years beginning after December 31,
1997.
______
By Mr. LAUTENBERG (for himself, Mr. DeWine, Mr. Glenn, and Mr.
Hatch):
S. 833. A bill to designate the Federal building courthouse at Public
Square and Superior Avenue in Cleveland, Ohio, as the ``Howard M.
Metzenbaum United States Courthouse''; to the Committee on Environment
and Public Works.
the howard m. metzenbaum united states courthouse designation act of
1997
Mr. LAUTENBERG. Mr. President, I rise today to congratulate my dear
friend and former colleague, Howard Metzenbaum, on the occasion of his
80th birthday. In his honor, I am introducing a bill that would
designate the Federal Building Courthouse in Cleveland, OH, as the
``Howard M. Metzenbaum United States Courthouse.'' I am joined by
Ohio's two Senators, Senator Glenn and Senator DeWine.
Mr. President, I propose naming a courthouse after Howard because a
courthouse is a symbol of justice where all people can come and be
treated equally under the law. Howard Metzenbaum deserves this honor
because he was a dedicated public servant, who served his home State of
Ohio for 18 years in the U.S. Senate. Howard's sense of fairness and
equality for all Americans led one of his former colleagues to suggest
that Howard would have made an exceptional U.S. Supreme Court Justice
when he retired from the Senate in 1994.
Mr. President, naming a courthouse after Howard is only a small
gesture in attempting to remember a man so committed to justice and
fairness. Howard's contributions to the Senate are extraordinary, so we
should commemorate his unique contribution by celebrating his 80th
year, his 18 years in the United States Senate, and also the special
character he brought to our body.
I pay tribute today to a man who always stood up for what he believed
was right, fighting hard to preserve opportunity for those yet to come.
As a Senator, Howard had a broad range of interests and he pursued them
with dogged perseverance, sincerity, and clarity.
Howard and I worked on many issues together during our time in the
Senate. Individual rights and environmental preservation were major
concerns. He poured his energy into clean air protection, nuclear
regulation, cleaning up superfund sites, and recycling. Howard provided
strong leadership on antitrust issues as Chairman of the Subcommittee
on Antitrust, Monopolies and Business Rights on the Judiciary
Committee.
He was a persistent gun control advocate, taking the lead on many
antigun initiatives in the Senate. He was one of the lead sponsors of
the Brady bill handgun purchase waiting period, as well as the bans on
assault weapons and plastic explosives.
But Howard's true passions lay with America's underprivileged and
needy communities, which never had a bolder champion. His work on
behalf of the poor, the disabled, and the elderly reflect his
remarkable compassion for those members of society who face challenges
that many of us cannot fully appreciate. He tirelessly defended their
interests and fought for their protection. He was dedicated to
eradicating discrimination, ensuring adequate health care to those in
need, and boosting public education. It has been said many times, but
for good reason, that Howard brought not only his conscience to the
Senate, but also the courage to act on his convictions.
Howard remains a good friend to me, but he was also a mentor and a
teacher during his years in the Senate. He gave me good advice and
plenty of it. And, I might add, he continues to do so today, which I
welcome. But more than that, his dedication to the office of United
States Senator is an example by which to live. He stood tall for the
little people.
Some will affectionately remember Howard as determined,
argumentative, and even ``irascible.'' I cannot deny that those words
come to my mind every now and then, when describing Howard. He was
always at his best then, and for good reason. I heard it said by one
Senator, and not a good friend: ``If there wasn't a Metzenbaum here,
we'd have to invent one to keep us alert.''
I have missed working with Howard Metzenbaum in this great
institution, a place that has been truly enhanced by his presence. I
salute him on celebrating his 80th year.
I ask unanimous consent that the text of the bill appear at the
appropriate place in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 833
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. DESIGNATION OF HOWARD M. METZENBAUM UNITED STATES
COURTHOUSE.
The Federal building courthouse at Public Square and
Superior Avenue in Cleveland, Ohio, shall be known and
designated as the ``Howard M. Metzenbaum United States
Courthouse''.
SEC. 2. REFERENCES.
Any reference in a law, map, regulation, document, paper,
or other record of the United States to the Federal building
courthouse referred to in section 1 shall be deemed to be a
reference to the ``Howard M. Metzenbaum United States
Courthouse''.
______
By Mr. HARKIN (for himself and Mr. Reed):
S. 834. A bill to amend the Public Health Service Act to ensure
adequate research and education regarding the drug DES; to the
Committee on Labor and Human Resources.
the DES Research and Education Amendments of 1997
Mr. HARKIN. Mr. President, today I am pleased to be joined by my
distinguished colleague from Rhode Island, Senator Reed, in introducing
an important women's health initiative. The DES Research and Education
Amendments of 1997 would extend and expand our effort to assist the
over 5 million Americans who have been exposed to
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the drug, DES. Representative Louise Slaughter, a long-time leader on
this issue, is introducing companion legislation today in the other
body.
Between 1938 and 1971, some 5 million American women were given the
synthetic drug, diethylstilbestrol, commonly known as DES. Women were
given the drug during pregnancy in the mistaken belief it would help
prevent miscarriage. The drug was pulled from the market based on
studies that found that it was ineffective and might result in damage
to children born to the women who had been given it.
Since the 1970's, studies have shown that DES does damage the
reproductive systems of those exposed in utero and increases these
individuals' risk for cancer, infertility, and a wide range of other
serious reproductive tract disorders. The women exposed in utero to DES
are five times more likely to have an ectopic pregnancy and three times
more likely to miscarry when they in turn try to have children. Studies
also show that one of every thousand women exposed to DES in utero will
develop clear cell cancer. Women who took DES have also been found to
face a higher risk for breast cancer.
In 1992, while there had been a number of research studies on DES
exposure and its effects, much more research was necessary. That year,
President Bush signed legislation introduced by myself and
Representative Slaughter, that mandated a significant increase in DES
research supported by the National Institutes of Health [NIH]. Our
legislation also required NIH to support long-term studies of Americans
impacted by this drug. Those studies are now underway and must be
continued. The legislation we are introducing today will ensure that
this critical medical research continues. In addition, there is now
preliminary evidence that the grandkids of women who took DES may also
be at higher risk for certain health problems, and this legislation
would help ensure that further research into this is supported.
Another major problem in this area is that millions of Americans
don't know the risks they face because of their exposure to DES. Many
health professionals who see these people also lack sufficient
information about DES exposure and the appropriate steps that should be
taken to identify and assist their patients. As a result, many people
do not seek or get the appropriate preventive care or take appropriate
preventive measures to reduce their risks of adverse affects. For
example, women exposed to DES in utero and therefore at higher risk of
miscarriage may be able to reduce their risks with appropriate
precautionary steps.
In an initial attempt to address this need for better information,
our 1992 legislation required NIH to test ways to educate the public
and health professionals about how to deal with DES exposure. The
legislation we are introducing today would give people across the
Nation access to the information developed through these pilot programs
by requiring a national consumer and health professional education
effort.
Mr. President, we took a very important step in 1992 to begin to
address the significant problem presented by DES exposure. And we did
it with strong bipartisan cooperation between a Democratic Congress and
a Republican President. That legislation expires this year. We need to
make sure that the progress we've made is continued. The 5 million
Americans whose health is at risk are depending on us to work together
to make sure that happens. I urge my colleagues to join me in support
of that effort. I ask unanimous consent that a copy of the legislation
be included in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 834
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``DES Research and Education
Amendments of 1997''.
SEC. 2. FINDINGS.
With respect to diethylstilbestrol (a drug commonly known
as DES), the Congress finds as follows:
(1) DES was widely prescribed to American women from 1938
to 1971 in the mistaken belief it would prevent miscarriage.
Approximately 5,000,000 pregnant women took the drug,
resulting in DES exposure for approximately 5,000,000
daughters and sons.
(2) Studies conducted since the 1970s have shown that DES
damages the reproductive systems of those exposed in utero
and increases the risk for cancer, infertility, and a wide
range of other serious reproductive tract disorders. These
disorders include a five-fold increased risk for ectopic
pregnancy for DES daughters and a three-fold increase in risk
for miscarriage and preterm labor. Studies have indicated
that exposure to DES may increase the risk for autoimmune
disorders and diseases.
(3) An estimated 1 in 1,000 women exposed to DES in utero
will develop clear cell cancer of the vagina or cervix. While
survival rates for clear cell cancer are over 80 percent when
it is detected early, there is still no effective treatment
for recurrences of this cancer.
(4) Studies also indicate a higher incidence of breast
cancer among mothers who took DES during pregnancy.
(5) While research on DES and its effects has produced
important advances to date, much more remains to be learned.
(6) Preliminary research results indicate that DES exposure
may have a genetic impact on the third generation--the
children of parents exposed to DES in utero--and that
estrogen replacement therapy may not be advisable for DES-
exposed women.
(7) All DES-exposed individuals have special screening and
health care needs, especially during gynecological exams and
pregnancy for DES daughters, who should receive high risk
care.
(8) Many Americans remain unaware of their DES exposure or
ignorant about proper health care and screening. There
remains a great need for a national education effort to
inform both the public and health care providers about the
health effects and proper health care practices for DES-
exposed individuals.
SEC. 3. REVISION AND EXTENSION OF PROGRAM FOR RESEARCH AND
AUTHORIZATION OF NEW NATIONAL PROGRAM OF
EDUCATION REGARDING DRUG DES.
(a) Permanent Extension of General Program.--Section
403A(e) of the Public Health Service Act (42 U.S.C. 283a(e))
is amended by striking ``for each of the fiscal years 1993
through 1996'' and inserting ``for fiscal year 1997 and each
subsequent fiscal year''.
(b) National Program for Education of Health Professionals
and Public.--From amounts appropriated for carrying out
section 403A of the Public Health Service Act (42 U.S.C.
283a), the Secretary of Health and Human Services, acting
through the heads of the appropriate agencies of the Public
Health Service, shall carry out a national program for the
education of health professionals and the public with respect
to the drug diethylstilbestrol (commonly known as DES). To
the extent appropriate, such national program shall use
methodologies developed through the education demonstration
program carried out under such section 403A. In developing
and carrying out the national program, the Secretary shall
consult closely with representatives of nonprofit private
entities that represent individuals who have been exposed to
DES and that have expertise in community-based information
campaigns for the public and for health care providers. The
implementation of the national program shall begin during
fiscal year 1998.
______
By Mr. ABRAHAM (for himself, Mr. McConnell, Mr. Coverdell, Mr.
Santorum, Mr. McCain and Mr. Ashcroft):
S. 836. A bill to offer small businesses certain protections from
litigation excesses; to the Committee on the Judiciary.
The Small Business Lawsuit Abuse Protection Act of 1997
Mr. ABRAHAM. Mr. President, I rise today to introduce the Small
Business Lawsuit Abuse Protection Act of 1997. This bill will provide
targeted relief from litigation excesses to small businesses.
Small businesses in Michigan and across the Nation have faced
increasingly burdensome litigation and desperately need relief from
unwarranted and costly lawsuits. While other sectors of our society and
our economy also need relief from litigation excesses, small businesses
by their very nature are particularly vulnerable to lawsuit abuses and
especially unable to bear the high costs of unjustified and unfair
litigation against them.
As this week is Small Business Week, it provides a fine opportunity
for us to focus on relieving the burdens faced by small businesses.
Small businesses represent the engine of our growing economy and
provide countless benefits to communities across America. The Research
Institute for Small and Emerging Business, for example, has estimated
that there are over 20 million small businesses in America and that
small businesses generate 50 percent of the country's private sector
output.
When I was in Michigan last week over the Memorial Day recess, I
heard story after story from small businesses about the constraints,
limitations, and
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fear imposed on them by the threat of abusive and unwarranted
litigation. I also heard about the high costs that they must pay for
liability insurance. Those represent costs that could be going to
expand small businesses, to provide more jobs, or to offer more
benefits. According to a recent Gallup survey, one out of every five
small businesses decides not to hire more employees, expand its
business, introduce a new product, or improve an existing one out of
fear of lawsuits.
Before the Memorial Day recess, Congress passed the Volunteer
Protection Act, which--if signed by the President--will provide
specific protections from abusive litigation to volunteers. The Senate
passed that legislation by an overwhelming margin of 99 to 1. That
legislation provides a model for further targeted reforms for sectors
that are particularly hard hit and in need of immediate relief.
Small businesses have carried an often unbearable load from
unwarranted and unjustified lawsuits. Data from San Diego's superior
court published by the Washington Legal Foundation revealed that
punitive damages were requested in 41 percent of suits against small
businesses. It is unfathomable that such a large proportion of our
small businesses are engaging in the sort of egregious misconduct that
would warrant a claim of punitive damages. Unfortunately, those sort of
findings are not unusual. The National Federation of Independent
Business has reported that 34 percent of Texas small business owners
have been sued or threatened with court action seeking punitive
damages. Those figures are outrageously high and simply cannot have
anything to do with actual wrongdoing.
We know of far too many examples of expensive and ridiculous legal
threats faced by our small businesses that they must defend every day.
In a case reported by the American Consulting Engineers Council, a
drunk driver had an accident after speeding and bypassing detour signs.
Eight hours after the crash, the driver had a blood alcohol level of
0.09. The driver sued the engineering firm that designed the road, the
contractor, the subcontractor, and the State highway department. Five
years later, and after expending exorbitant amounts on legal fees, the
defendants settled the case for $35,000. The engineering firm--a small
15 person firm--was swamped with over $200,000 in legal costs. That
represents an intolerable amount for a small business to have to pay in
defending a questionable and unwarranted lawsuit.
There are more examples. In an Ann Landers column from October 1995,
a case was reported that involved a minister and his wife who sued a
guide dog school for $160,000 after a blind man who was learning to use
a seeing-eye dog stepped on the woman's toes in a shopping mall. The
guide dog school, Southeastern Guide Dogs, Inc., which provided the
instructor supervising the man, was the only school of its kind in the
Southeast. It trains seeing-eye dogs at no cost to the visually
impaired. The couple filed their lawsuit 13 months after the so-called
accident, in which witnesses reported that the woman did not move out
of the blind man's way because she wanted to see if the dog would walk
around her.
The experiences of a small business in Michigan, the Michigan Furnace
Co., is likewise alarming. The plawsuit in the history of her company
has been a nuisance lawsuit. She indicates that if the money the
company spends on liability insurance and legal fees was distributed
among the employees, it would amount to a $10,000 annual raise per
employee.
These costs are stifling our small businesses and the people who work
there. The straightforward provisions of the Small Business Lawsuit
Abuse Protection Act will provide small businesses with relief by
discouraging abusive litigation. The bill contains essentially two
principal reforms.
First, the bill limits punitive damages that may be awarded against a
small business. In most civil lawsuits against small businesses,
punitive damages would be available against the small business only if
the claimant proves by clear and convincing evidence that the harm was
caused by the small business through at least a conscious, flagrant
indifference to the rights and safety of the claimant. Punitive damages
would also be limited in amount. Punitive damages would be limited to
the lesser of $250,000 or two times the compensatory damages awarded
for the harm. That formulation is exactly the same formulation that
appears in the small business protection provision that was included in
the product liability conference report that passed in the 104th
Congress.
Second, joint and several liability reforms for small businesses are
included under the exact same formulation that was used both in the
Volunteer Protection Act passed this Congress and in the product
liability conference report passed last Congress. Joint and several
liability would be limited so that a small business would be liable for
noneconomic damages only in proportion to the small business's
responsibility for causing the harm. If a small business is responsible
for 100% of an accident, then it will be liable for 100% of noneconomic
damages. But if it is only 70%, 25%, 10%, or any other amount
responsible, then the small business will be liable only for that same
percent of noneconomic damages.
Of course, small businesses would still be jointly and severally
liable for economic damages, and any other defendants in the action
that were not small businesses could be held jointly and severally
liable for all damages. This should provide some protection to small
businesses so that they will not be sought out as ``deep pocket''
defendants by trial lawyers who would otherwise try to get them on the
hook for harms that they have not caused. The fact is that many small
businesses simply do not have deep pockets, and they frequently need
all of their resources just to stay in business, take care of their
employees, and make ends meet.
The other provisions in the bill specify the situations in which
those reforms apply. The bill defines small business as any business
having fewer than 25 employees. That is the same definition of small
business that was included in the Product Liability Conference Report.
Like the Volunteer Protection Act, this bill covers all civil lawsuits
with the exception of suits involving certain types of egregious
conduct. The limitations on liability included in the bill would not
apply to any misconduct that constitutes a crime of violence, act of
international terrorism, hate crime, sexual offense, or civil rights
law violation, or which occurred while the defendant was under the
influence of intoxicating alcohol or any drug.
Also like the Volunteer Protection Act, the bill includes a State
opt-out. A State would be able to opt out of the provisions of the bill
provided the State enacts a law indicating its election to do so and
containing no other provisions. I do not expect that any State will
opt-out of these provisions, but I feel it is important to include one
out of respect for principles of federalism.
I am pleased to have Senators McConnell, Coverdell, Santorum and
McCain as original cosponsors of the legislation and very much
appreciate their support for our small businesses and for meaningful
litigation reforms. The bill is also supported by the National
Federation of Independent Business and by the National Restaurant
Association. I ask unanimous consent that letters from those two
organizations be inserted in the Record.
Finally, I ask unanimous consent that a section-by-section analysis
of the bill be printed in the Record, as well as the full text of the
bill, and I encourage my colleagues to support this simple and much-
needed legislation.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 836
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Small Business Lawsuit Abuse
Protection Act of 1997''.
SEC. 2. FINDINGS.
Congress finds that--
(1) the United States civil justice system is inefficient,
unpredictable, unfair, costly, and impedes competitiveness in
the marketplace for goods, services, business, and employees;
(2) the defects in the civil justice system have a direct
and undesirable effect on interstate commerce by decreasing
the availability of goods and services in commerce;
(3) there is a need to restore rationality, certainty, and
fairness to the legal system;
(4) the spiralling costs of litigation and the magnitude
and unpredictability of punitive
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damage awards and noneconomic damage awards have continued
unabated for at least the past 30 years;
(5) the Supreme Court of the United States has recognized
that a punitive damage award can be unconstitutional if the
award is grossly excessive in relation to the legitimate
interest of the government in the punishment and deterrence
of unlawful conduct;
(6) just as punitive damage awards can be grossly
excessive, so can it be grossly excessive in some
circumstances for a party to be held responsible under the
doctrine of joint and several liability for damages that
party did not cause;
(7) as a result of joint and several liability, entities
including small businesses are often brought into litigation
despite the fact that their conduct may have little or
nothing to do with the accident or transaction giving rise to
the lawsuit, and may therefore face increased and unjust
costs due to the possibility or result of unfair and
disproportionate damage awards;
(8) the costs imposed by the civil justice system on small
businesses are particularly acute, since small businesses
often lack the resources to bear those costs and to challenge
unwarranted lawsuits;
(9) due to high liability costs and unwarranted litigation
costs, small businesses face higher costs in purchasing
insurance through interstate insurance markets to cover their
activities;
(10) liability reform for small businesses will promote the
free flow of goods and services, lessen burdens on interstate
commerce, and decrease litigiousness; and
(11) legislation to address these concerns is an
appropriate exercise of Congress powers under Article I,
section 8, clauses 3, 9, and 18 of the Constitution, and the
fourteenth amendment to the Constitution.
SEC. 3. DEFINITIONS.
In this Act:
(1) Act of international terrorism.--The term ``act of
international terrorism'' has the same meaning as in section
2331 of title 18, United States Code).
(2) Crime of violence.--The term ``crime of violence'' has
the same meaning as in section 16 of title 18, United States
Code.
(3) Drug.--The term ``drug'' means any controlled substance
(as that term is defined in section 102 of the Controlled
Substances Act (21 U.S.C. 802(b)) that was not legally
prescribed for use by the defendant or that was taken by the
defendant other than in accordance with the terms of a
lawfully issued prescription.
(4) Economic loss.--The term ``economic loss'' means any
pecuniary loss resulting from harm (including the loss of
earnings or other benefits related to employment, medical
expense loss, replacement services loss, loss due to death,
burial costs, and loss of business or employment
opportunities) to the extent recovery for such loss is
allowed under applicable State law.
(5) Harm.--The term ``harm'' includes physical,
nonphysical, economic, and noneconomic losses.
(6) Hate crime.--The term ``hate crime'' means a crime
described in section 1(b) of the Hate Crime Statistics Act
(28 U.S.C. 534 note)).
(7) Noneconomic losses.--The term ``noneconomic losses''
means losses for physical and emotional pain, suffering,
inconvenience, physical impairment, mental anguish,
disfigurement, loss of enjoyment of life, loss of society and
companionship, loss of consortium (other than loss of
domestic service), injury to reputation, and all other
nonpecuniary losses of any kind or nature.
(8) Small business.--
(A) In general.--The term ``small business'' means any
unincorporated business, or any partnership, corporation,
association, unit of local government, or organization that
has less than 25 full-time employees.
(B) Calculation of number of employees.--For purposes of
subparagraph (A), the number of employees of a subsidiary of
a wholly-owned corporation includes the employees of--
(i) a parent corporation; and
(ii) any other subsidiary corporation of that parent
corporation.
(10) State.--The term ``State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such
State, territory, or possession.
SEC. 4. LIMITATION ON PUNITIVE DAMAGES FOR SMALL BUSINESSES.
(a) General Rule.--Except as provided in section 6, in any
civil action against a small business, punitive damages may,
to the extent permitted by applicable State law, be awarded
against the small business only if the claimant establishes
by clear and convincing evidence that conduct carried out by
that defendant through willful misconduct or with a
conscious, flagrant indifference to the rights or safety of
others was the proximate cause of the harm that is the
subject of the action.
(b) Limitation on Amount.--In any civil action against a
small business, punitive damages shall not exceed the lesser
of--
(1) two times the total amount awarded to the claimant for
economic and noneconomic losses; or
(2) $250,000.
(c) Application by Court.--This section shall be applied by
the court and shall not be disclosed to the jury.
SEC. 5. LIMITATION ON SEVERAL LIABILITY FOR NONECONOMIC LOSS
FOR SMALL BUSINESSES.
(a) General Rule.--Except as provided in section 6, in any
civil action against a small business, the liability of each
defendant that is a small business, or the agent of a small
business, for noneconomic loss shall be determined in
accordance with subsection (b).
(b) Amount of Liability.--
(1) In General.--In any civil action described in
subsection (a)--
(A) each defendant described in that subsection shall be
liable only for the amount of noneconomic loss allocated to
that defendant in direct proportion to the percentage of
responsibility of that defendant (determined in accordance
with paragraph (2)) for the harm to the claimant with respect
to which the defendant is liable; and
(B) the court shall render a separate judgment against each
defendant described in that subsection in an amount
determined pursuant to subparagraph (A).
(2) Percentage of responsibility.--For purposes of
determining the amount of noneconomic loss allocated to a
defendant under this section, the trier of fact shall
determine the percentage of responsibility of each person
responsible for the harm to the claimant, regardless of
whether or not the person is a party to the action.
SEC. 6. EXCEPTIONS TO LIMITATIONS ON LIABILITY.
The limitations on liability under sections 4 and 5 do not
apply to any misconduct of a defendant--
(1) that constitutes--
(A) a crime of violence;
(B) an act of international terrorism; or
(C) a hate crime;
(2) that involves--
(A) a sexual offense, as defined by applicable State law;
or
(B) a violation of a Federal or State civil rights law; or
(3) if the defendant was under the influence (as determined
pursuant to applicable State law) of intoxicating alcohol or
a drug at the time of the misconduct, and the fact that the
defendant was under the influence was the cause of any harm
alleged by the plaintiff in the subject action.
SEC. 7. PREEMPTION AND ELECTION OF STATE NONAPPLICABILITY.
(a) Preemption.--Subject to subsection (b), this Act
preempts the laws of any State to the extent that State laws
are inconsistent with this Act, except that this Act shall
not preempt any State law that provides additional
protections from liability for small businesses.
(b) Election of State Regarding Nonapplicability.--This Act
does not apply to any action in a State court against a small
business in which all parties are citizens of the State, if
the State enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act does
not apply as of a date certain to such actions in the State;
and
(3) containing no other provision.
SEC. 8. EFFECTIVE DATE.
(a) In General.--This Act shall take effect 90 days after
the date of enactment of this Act.
(b) Application.--This Act applies to any claim for harm
caused by an act or omission of a small business, if the
claim is filed on or after the effective date of this Act,
without regard to whether the harm that is the subject of the
claim or the conduct that caused the harm occurred before
such effective date.
____
Section-by-Section Analysis--The Small Business Lawsuit Abuse
Protection Act of 1997
section 1. short title
This section provides that the act may be cited as the
``Small Business Lawsuit Abuse Protection Act of 1997.''
section 2. findings
This section sets out congressional findings concerning the
litigation excesses facing small businesses, and the need for
litigation reforms to provide certain protections to small
businesses from abusive litigation.
section 3. definitions
Various terms used in the bill are defined in the section.
Significantly, for purposes of the legislation, a small
business is defined as any business or organization with
fewer than 25 full time employees.
section 4. limitation on punitive damages for small businesses
The bill provides that punitive damages may, to the extent
permitted by applicable State law, be awarded against a
defendant that is a small business only if the claimant
establishes by clear and convincing evidence that conduct
carried out by that defendant with a conscious, flagrant
indifference to the rights or safety of others was the
proximate cause of the harm that is the subject of the
action.
The bill also limits the amount of punitive damages that
may be awarded against a small business. In any civil action
against a small business, punitive damages may not exceed the
lesser of two times the amount awarded to the claimant for
economic and noneconomic losses, or $250,000.
section 5. limitation on several liability for noneconomic loss for
small businesses
This section provides that, in any civil action against a
small business, for each defendant that is a small business,
the liability of that defendant for noneconomic loss will be
in proportion to that defendant's responsibility for causing
the harm. Those defendants would continue, however, to be
held
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jointly and severally liable for
Major Actions:
All articles in Senate section
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
(Senate - June 05, 1997)
Text of this article available as:
TXT
PDF
[Pages
S5342-S5368]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. JEFFORDS:
S. 830. A bill to amend the Federal Food, Drug, and Cosmetic Act and
the Public Health Service Act to improve the regulation of food, drugs,
devices, and biological products, and for other purposes; to the
Committee on Labor and Human Resources.
the food and drug administration modernization and accountability act
of 1997
Mr. JEFFORDS. Mr. President, today I am introducing legislation to
modernize the Food and Drug Administration [FDA] and reauthorize the
Prescription Drug User Fee Act for 5 years. This legislation comes as
result of over 3 years of consideration by the Congress on steps that
could be taken by the agency that would contribute to its mandate to
protect the American public while ensuring that life-saving products
could be made more readily available.
FDA acknowledges that its mandate also requires it to regulate over
one-third of our Nation's products. Within its purview the FDA
regulates virtually all of the food and all of the cosmetics, medical
devices, and drugs made available to our citizens. I believe, and
several members of the Labor Committee share my belief, that in an
organization the size of FDA there is always room for improvement and
modernization. Our objective, which this legislation achieves, was
identify areas where improvements could be made that will strengthen
the agency's ability to approve safe and effective products more
expeditiously.
Last year, both the House and the Senate held numerous and extensive
hearings on countless proposals for modernizing and reforming the FDA.
The Senate Labor and Human Resources Committee successfully reported a
bipartisan bill that sought to accomplish many of those reforms. But
last year, acrimonious issues remained, time ran out and the bill did
not receive floor consideration. This year I have resolved to move
forward. I have been committed to addressing last year's most
controversial issues. I believe that the legislation I am introducing
today addresses virtually all of objections raised last year both in
process and in content. This is a better bill and I believe that upon
examination, my colleagues will agree that it accomplishes its goal.
I want to comment a moment on the open, consensus-building process we
followed in developing this legislation. The Labor Committee held two
hearings. During the first the committee received testimony from the
principal FDA Deputy Commissioner, Dr. Michael Friedman, and all of the
FDA Center Directors. The second hearing included representatives from
patient and consumer coalitions and from the food, drug, and medical
device sectors regulated by the FDA. Committee members learned from the
agency of the administrative reforms and the progress it has already
undertaken, areas that remain a challenge, and those areas that require
legislative authority to change. The committee listened to consumers'
concerns with provisions that were considered last year that they felt
would weaken the FDA's ability to protect the public health. Finally,
the committee learned of the ongoing and needless delays and
frustrations facing health care and consumer product sectors of our
economy in working with the FDA. The committee learned of the
frustrated attempts to work through the bureaucratic labyrinth of
needless regulatory delays. Delays that prohibited people from getting
access to vitally needed, life saving medical treatments, drugs, and
devices.
Since the finish of the committee's hearings we have engaged in an
open, collaborative process that has given voice to each party wishing
to be heard. For many of these meetings it is worth noting that the
agency was a full, cooperating participant and we would not have been
able to make the progress made without FDA's collaboration. Several
meetings, essentially roundtable discussions, have occurred with
bipartisan committee staff, the FDA, and each of the several sectors
regulated by the agency. These meetings have given all the participants
an opportunity to discuss problems and potential solutions and have
been the basis for the consensus bill I am introducing today. Finally,
committee staff have had numerous meetings to discuss key provisions in
the bill with a wide range of consumer groups including, among others,
the Patient Coalition, Public Citizen, the Centers for Science in the
Public Interest, the Pediatric AIDS Foundation, and the National
Organization for Rare Diseases. It should be clear that no person or
group was excluded from this deliberative process.
Let me turn to the content of this measure and the steps we have
taken to respond to the controversies raised last year. Five key
objections were raised against the FDA reform bill that had been
reported on a strong bipartisan vote from the Labor and Human Resources
Committee during the last Congress. In that vein, we have sought to and
have accomplished addressing each of the substantive concerns raised by
the minority.
Last year's measure was criticized by some for the number of
mandatory, but shortened, product review time frames that critics said
would overburden the FDA and for the hammers that would have required
FDA to contract out some product reviews or to give priority to
products approved abroad. Today's legislation eliminates most of the
mandatory time frames and retains only those necessary to ensure
collaborative, more efficient reviews or to facilitate quick reviews of
low risk products. The contracting out and European review hammers that
would have forced FDA actions have been eliminated.
Last year's provision allowing for third party, outside expert review
were criticized for turning central regulatory authority decisions over
to private industry, creating conflicts of interest, and depriving FDA
of resources and expertise. Today's legislation adopts FDA's current
system for accrediting and selecting third-party review organizations.
The bill expands FDA's current pilot third-party review program beyond
just the lowest risk devices and FDA retains final approval for all
devices. Devices that are life-
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supporting, life-sustaining, or implantable are excluded from third-
party review. FDA may allow third-party review for higher risk devices
at its sole discretion. This approval will allow FDA to retain,
augment, and focus its expertise, at its discretion, on critical areas
of its expanding workload.
Last year's bill would have required FDA to contract out review of
food additive petitions, medical devices, and drugs. Critics argued
these changes would weaken consumer protections. We have modified these
provisions to give FDA express authority to contract out when deemed by
FDA to be more efficient or to add needed expertise.
Thsi year the collaborative effort has continued. During our meetings
FDA identified a number of enforcement powers that the agency believes
will enhance its ability to protect the public health. We have included
a number of FDA's specific requests. Many patient and consumer groups
raised concerns about insufficient safeguards related to the fast-track
drug approval process and the provision improving accelerated access to
investigational products and we have adopted several of their key
concerns.
I would close by saying that this measure embodies a reasonable,
moderate approach to balancing the agency's mandate to regulate over
one-third of our Nation's economy and provide for the public health and
safety with the compelling need to provide new, improved, safe, and
effective products to the American public. It is a good bill and I look
forward to working with my colleagues to improve it even further.
______
By Mr. SHELBY (for himself, Mr. Bond, Mr. Hagel, Mr. Hutchinson,
and Mr. Coverdell):
S. 831. A bill to amend chapter 8 of title 5, United States Code, to
provide for congressional review of any rule promulgated by the
Internal Revenue Service that increases Federal revenue, and for other
purposes; to the Committee on Governmental Affairs.
the stealth tax prevention act
Mr. SHELBY. Mr. President, I rise today to introduce the Stealth Tax
Prevention Act. Perhaps the most important power given to the Congress
in the Constitution of the United States is bestowed in article I,
section 8--the power to tax. This authority is vested in Congress
because, as elected representatives, Congress remains accountable to
the public when they lay and collect taxes.
Last year, Mr. President, Congress passed the Congressional Review
Act of 1996, which provides that when a major agency rule takes effect,
Congress has 60 days to review it. During this time period, Congress
has the option to pass a disapproval resolution. If no such resolution
is passed, the rule then goes into effect.
The Internal Revenue Service, as the President here knows, has
enormous power to affect the lives and the livelihoods of American
taxpayers through their authority to interpret the Tax Code. The
Stealth Tax Prevention Act that I am introducing today, along with
Senator Bond and Senator Hagel, will expand the definition of a major
rule to include, Mr. President, any IRS regulation which increases
Federal revenue. Why? Because we desperately need this today.
For example, if the Office of Management and Budget finds that the
implementation and enforcement of a rule has resulted in an increase of
Federal revenues over current practices or revenues anticipated from
the rule on the date of the enactment of the statute under which the
rule is promulgated. Therefore, the Stealth Tax Prevention Act will
allow Congress to review the regulation and take appropriate measures
to avoid raising taxes on hard-working Americans, in most cases, small
businesses.
Mr. President, the Founding Fathers' intent, as you know, was to put
the power to lay and collect taxes in the hands of elected Members of
Congress, not in the hands of bureaucrats who are shielded from public
accountability. It is appropriate, I believe, that the IRS's breach of
authority is addressed, in light of the fact that we are celebrating
this week Small Business Week.
The discretionary authority of the Internal Revenue Service exposes
small businesses, farmers, and others to the arbitrary whims of
bureaucrats, thus creating an uncertain and, under certain cases,
hostile environment in which to conduct day-to-day activities. Most of
these people do not have lobbyists that work for them, other than their
elected Representatives, the way it should be. The Stealth Tax
Prevention Act will be particularly helpful in lowering the tax burden
on small business which suffers disproportionately, Mr. President, from
IRS regulations. This burden discourages the startup of new firms and
ultimately the creation of new jobs in the economy, which has really
made America great today.
Americans pay Federal income taxes. They, Mr. President, as you well
know, pay State income taxes. They pay property taxes. On the way to
work in the morning they pay a gasoline tax when they fill up their
car, and a sales tax when they buy a cup of coffee.
Mr. President, average Americans in small businesses are saddled with
the highest tax burden in our country's history.
Allowing bureaucrats to increase taxes even further, at their own
discretion through interpretation of the Tax Code is intolerable. The
Stealth Tax Prevention Act will leave tax policy where it belongs, to
elected Members of the Congress, not unelected and unaccountable IRS
bureaucrats.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 831
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. CONGRESSIONAL REVIEW OF INTERNAL REVENUE SERVICE
RULES THAT INCREASE REVENUE.
(a) Short Title.--This Act may be cited as the ``Stealth
Tax Prevention Act''.
(b) In General.--Section 804(2) of title 5, United States
Code, is amended to read as follows:
``(2) The term `major rule'--
``(A) means any rule that--
``(i) the Administrator of the Office of Information and
Regulatory Affairs of the Office of Management and Budget
finds has resulted in or is likely to result in--
``(I) an annual effect on the economy of $100,000,000 or
more;
``(II) a major increase in costs or prices for consumers,
individual industries, Federal, State, or local government
agencies, or geographic regions; or
``(III) significant adverse effects on competition,
employment, investment, productivity, innovation, or on the
ability of United States-based enterprises to compete with
foreign-based enterprises in domestic and export markets; or
``(ii)(I) is promulgated by the Internal Revenue Service;
and
``(II) the Administrator of the Office of Information and
Regulatory Affairs of the Office of Management and Budget
finds that the implementation and enforcement of the rule has
resulted in or is likely to result in any net increase in
Federal revenues over current practices in tax collection or
revenues anticipated from the rule on the date of the
enactment of the statute under which the rule is promulgated;
and
``(B) does not include any rule promulgated under the
Telecommunications Act of 1996 and the amendments made by
that Act.''.
Mr. BOND. Mr. President, I rise today to join my distinguished
colleague from Alabama, Senator Shelby, in introducing legislation to
ensure that the Treasury Department's Internal Revenue Service does not
usurp the power to tax--a power solely vested in Congress by the U.S.
Constitution. The Stealth Tax Prevention Act will ensure that the duly
elected representatives of the people, who are accountable to the
electorate for our actions, will have discretion to exercise the power
to tax. This legislation is intended to curb the ability of the
Treasury Department to bypass Congress by proposing a tax increase
without the authorization or consent of Congress.
The Stealth Tax Prevention Act builds on legislation passed
unanimously by the Senate just over 1 year ago. As chairman of the
Committee on Small Business, I authored the Small Business Regulatory
Enforcement Fairness Act--better known as the Red Tape Reduction Act--
to ensure that small businesses are treated fairly in agency rulemaking
and enforcement activities. Subtitle E of the Red Tape Reduction Act
provides that a final rule issued by a Federal agency and deemed a
major rule by the Office of Information and Regulatory Affairs of the
Office of Management and Budget
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cannot go into effect for at least 60 days. This delay is to provide
Congress with a window during which it can review the rule and its
impact, allowing time for Congress to consider whether a resolution of
disapproval should be enacted to strike down the regulation. To become
effective, the resolution must pass both the House and Senate and be
signed into law by the President or enacted as the result of a veto
override.
The bill Senator Shelby and I introduce today amends this law to
provide that any rule issued by the Treasury Department's Internal
Revenue Service that will result in a tax increase--any increase--will
be deemed a major rule by OIRA and, consequently, not go into effect
for at least 60 days. This procedural safeguard will ensure that the
Department of the Treasury and its Internal Revenue Service cannot make
an end-run around Congress, as it is currently attempting with the
stealth tax it proposed on January 13.
As my colleagues are aware, the IRS has issued a proposal that is
tantamount to a tax increase on businesses structured as limited
liability companies. The IRS proposal disqualifies a taxpayer from
being considered as a limited partner if he or she ``participates in
the partnership's trade or business for more than 500 hours during a
taxable year'' or is involved in a ``service'' partnership, such as
lawyers, accountants, engineers, architects, and health-care providers.
The IRS alleges that its proposal merely interprets section
1402(a)(13) of the Tax Code, providing clarification, when in actuality
it is a tax increase by regulatory fiat. Under the IRS proposal,
disqualification as a limited partner will result in a tax increase on
income from both capital investments as well as earnings of the
partnership. The effect will be to add the self-employment tax--12.4
percent for social security and 2.9 percent for Medicare--to income
from investments as well as earnings for limited partners that under
current rules can exclude such income from the self-employment tax.
Under the bill introduced today, the tax increase proposed by the
Internal Revenue Service of the Treasury Department, if later issued as
a final rule, could not go into effect for at least 60 days following
its publication in the Federal Register. This window, which coincides
with issuance of a report by the Comptroller General, would allow
Congress the opportunity to review the rule and vote on a resolution to
disapprove the tax increase before it is applied to a single taxpayer.
The Stealth Tax Prevention Act strengthens the Red Tape Reduction Act
and the vital procedural safeguards it provides to ensure that small
businesses are not burdened unnecessarily by new Federal regulations.
Congress enacted the 1966 provisions to strengthen the effectiveness of
the Regulatory Flexibility Act, a law which had been ignored too often
by Government agencies, especially the Internal Revenue Service. Three
of the top recommendations of the 1995 White House Conference on Small
Business sought reforms to the way Government regulations are developed
and enforced, and the Red Tape Reduction Act passed the Senate without
a single dissenting vote on its way to being signed into law last year.
Despite the inclusion of language in the 1996 amendments that expressly
addresses coverage of IRS interpretative rules, we find ourselves faced
again with an IRS proposal that was not issued in compliance with the
Regulatory Flexibility Act.
As 18 of my Senate colleagues and I advised Secretary Rubin in an
April letter, the proposed IRS regulation on limited partner taxation
is precisely the type of rule for which a regulatory flexibility
analysis should be done. Although, on its face, the rulemaking seeks
merely to define a limited partner or to eliminate uncertainty in
determining net earnings from self-employment, the real effect of the
rule would be to raise taxes by executive fiat and expand substantially
the spirit and letter of the underlying statute. The rule also seeks to
impose on small businesses a burdensome new recordkeeping and
collection of information requirement that would affect millions of
limited partners and members of limited liability companies. The
Treasury's IRS proposes this stealth tax increase with the knowledge
that Congress declined to adopt a similar tax increase in the Health
Security Act proposed in 1994--a provision that the Congressional Joint
Committee on Taxation estimated in 1994 would have resulted in a tax
increase of approximately $500 million per year.
The Stealth Tax Prevention Act would remove any incentive for the
Treasury Department to underestimate the cost imposed by an IRS
proposed or final rule in an effort to skirt the administration's
regulatory review process or its obligations under the Regulatory
Flexibility Act. By amending the definition of major rule under the
Congressional Review Act, which is subtitle E of the Red Tape Reduction
Act, we ensure that an IRS rule that imposes a tax increase will be a
major rule, whether or not it has an estimated annual effect on the
economy of $100,000,000. Our amendment does not change the trigger for
a regulatory flexibility analysis, which still will be required if a
proposed rule would have a significant economic impact on a substantial
number of small entities. We believe the heightened scrutiny of IRS
regulations called for by this legislation will provide an additional
incentive for the Treasury Department's Internal Revenue Service to
meet all of its procedural obligations under the Regulatory Flexibility
Act and the Red Tape Reduction Act.
I urge my colleagues to join Senator Shelby and me in supporting this
important legislation to ensure that the IRS not usurp the proper role
of Congress--nor skirt its obligations to identify the impact of its
proposed and final rules. Rules such as that currently proposed by the
IRS should be carefully scrutinized by Congress. When the Department of
the Treasury issues a final IRS rule that increases taxes, Congress
should have the ability to exercise its discretion to enact a
resolution of disapproval before the rule is applicable to a single
taxpayer. The Stealth Tax Prevention Act Senator Shelby and I introduce
today provides that opportunity.
______
By Mr. KOHL (for himself, Mr. Kerrey, Mr. Harkin, Mr. Hatch, Mr.
Hagel, and Mr. Grassley):
S. 832. A bill to amend the Internal Revenue Code of 1986 to increase
the deductibility of business meal expenses for individuals who are
subject to Federal limitations on hours of service; to the Committee on
Finance.
The Business Meal Deduction Fairness Act of 1997
Mr. KOHL. Mr. President, as my colleagues know, I am one of this
body's strongest advocates for deficit reduction. I attribute much of
my deep commitment to this goal to my days in business. As a
businessman, I learned that you must balance your books and live within
your means. I also learned that you must treat people fairly and admit
when you have made a mistake. I have come to the floor to acknowledge
that a mistake has been made, and must be corrected.
In August 1993 we passed the omnibus budget reconciliation bill. I am
proud to say that this legislation has helped to produce falling
deficits and sustained economic growth. However, in our efforts to get
our fiscal house in order we unfairly penalized a group of hard
working, middle-class Americans: transportation workers. It is for this
reason that I rise today, to reintroduce the business meal deduction
fairness bill. This measure would increase the deductibility of
business meals, from 50 to 80 percent, for individuals who are required
to eat away from home due to the nature of their work.
In the 1993 reconciliation bill was a provision which lowered the
deductible portion of business meals and entertainment expenses from 80
to 50 percent. The change was aimed at the so-called three martini
lunches and extravagant entertainment expenses of Wall Street
financiers and Hollywood movie moguls. Unfortunately, the change also
hit the average truck driver who eats chicken fried steak, hot roast
beef sandwiches, and meatloaf in truck stops. And while those who
entertain for business purposes can change their practices based on the
tax law change, long-haul transportation workers often have no choice
but to eat on the road.
For these workers, the 1993 decrease in the meal deduction has
translated into an undeserved decrease in take home pay. For example,
when the allowable deduction was dropped in 1993,
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it increased taxes on an average truck driver $700 to $2,000 per year.
This is a huge increase for a truck driver who normally earns $27,000
to $35,000 per year.
Our legislation would increase the take-home pay of hard working,
middle-class Americans who were inadvertently hurt by changes in the
tax law in 1993. Workers who, due to regulations limiting travel hours,
must eat out. They have no control over the length of their trips, the
amount of time they must rest during a delivery, or, in many cases, the
places they can stop and eat. This legislation is straight forward. It
would simply restore the business meal expense deduction to 80 per cent
for individuals subject to the Department of Transportation's hours-of-
service limitations.
I will be the first to admit that the budget deficit is the No. 1
economic problem facing this country. Since being elected to the
Senate, I have fought to eliminate this destructive drain on our
ability to grow and compete in the world economy, but I have fought to
do so in a fair manner. The 1993 reconciliation bill closed a loophole
and unintentionally trapped some very hard working Americans. We need
to acknowledge that a mistake was made and take the opportunity of a
tax bill moving this year to fix that mistake. Therefore my colleagues,
Senators Kerrey, Harkin, Hatch, Hagel, Grassley and I are requesting
the support and assistance of this entire body to ensure that the
business meal deduction fairness bill becomes law. Mr. President, I ask
unanimous consent that a copy of my legislation be printed in the
Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 832
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. INCREASED DEDUCTIBILITY OF BUSINESS MEAL EXPENSES
FOR INDIVIDUALS SUBJECT TO FEDERAL LIMITATIONS
ON HOURS OF SERVICE.
(a) In General.--Section 274(n) of the Internal Revenue
Code of 1986 (relating to only 50 percent of meal and
entertainment expenses allowed as deduction) is amended by
adding at the end the following new paragraph:
``(3) Special rule for individuals subject to federal
limitations on hours of service.--In the case of any expenses
for food or beverages consumed by an individual during, or
incident to, any period of duty which is subject to the hours
of service limitations of the Department of Transportation,
paragraph (1) shall be applied by substituting `80 percent'
for `50 percent'.''
(b) Effective Date.--The amendment made by subsection (a)
shall apply to taxable years beginning after December 31,
1997.
______
By Mr. LAUTENBERG (for himself, Mr. DeWine, Mr. Glenn, and Mr.
Hatch):
S. 833. A bill to designate the Federal building courthouse at Public
Square and Superior Avenue in Cleveland, Ohio, as the ``Howard M.
Metzenbaum United States Courthouse''; to the Committee on Environment
and Public Works.
the howard m. metzenbaum united states courthouse designation act of
1997
Mr. LAUTENBERG. Mr. President, I rise today to congratulate my dear
friend and former colleague, Howard Metzenbaum, on the occasion of his
80th birthday. In his honor, I am introducing a bill that would
designate the Federal Building Courthouse in Cleveland, OH, as the
``Howard M. Metzenbaum United States Courthouse.'' I am joined by
Ohio's two Senators, Senator Glenn and Senator DeWine.
Mr. President, I propose naming a courthouse after Howard because a
courthouse is a symbol of justice where all people can come and be
treated equally under the law. Howard Metzenbaum deserves this honor
because he was a dedicated public servant, who served his home State of
Ohio for 18 years in the U.S. Senate. Howard's sense of fairness and
equality for all Americans led one of his former colleagues to suggest
that Howard would have made an exceptional U.S. Supreme Court Justice
when he retired from the Senate in 1994.
Mr. President, naming a courthouse after Howard is only a small
gesture in attempting to remember a man so committed to justice and
fairness. Howard's contributions to the Senate are extraordinary, so we
should commemorate his unique contribution by celebrating his 80th
year, his 18 years in the United States Senate, and also the special
character he brought to our body.
I pay tribute today to a man who always stood up for what he believed
was right, fighting hard to preserve opportunity for those yet to come.
As a Senator, Howard had a broad range of interests and he pursued them
with dogged perseverance, sincerity, and clarity.
Howard and I worked on many issues together during our time in the
Senate. Individual rights and environmental preservation were major
concerns. He poured his energy into clean air protection, nuclear
regulation, cleaning up superfund sites, and recycling. Howard provided
strong leadership on antitrust issues as Chairman of the Subcommittee
on Antitrust, Monopolies and Business Rights on the Judiciary
Committee.
He was a persistent gun control advocate, taking the lead on many
antigun initiatives in the Senate. He was one of the lead sponsors of
the Brady bill handgun purchase waiting period, as well as the bans on
assault weapons and plastic explosives.
But Howard's true passions lay with America's underprivileged and
needy communities, which never had a bolder champion. His work on
behalf of the poor, the disabled, and the elderly reflect his
remarkable compassion for those members of society who face challenges
that many of us cannot fully appreciate. He tirelessly defended their
interests and fought for their protection. He was dedicated to
eradicating discrimination, ensuring adequate health care to those in
need, and boosting public education. It has been said many times, but
for good reason, that Howard brought not only his conscience to the
Senate, but also the courage to act on his convictions.
Howard remains a good friend to me, but he was also a mentor and a
teacher during his years in the Senate. He gave me good advice and
plenty of it. And, I might add, he continues to do so today, which I
welcome. But more than that, his dedication to the office of United
States Senator is an example by which to live. He stood tall for the
little people.
Some will affectionately remember Howard as determined,
argumentative, and even ``irascible.'' I cannot deny that those words
come to my mind every now and then, when describing Howard. He was
always at his best then, and for good reason. I heard it said by one
Senator, and not a good friend: ``If there wasn't a Metzenbaum here,
we'd have to invent one to keep us alert.''
I have missed working with Howard Metzenbaum in this great
institution, a place that has been truly enhanced by his presence. I
salute him on celebrating his 80th year.
I ask unanimous consent that the text of the bill appear at the
appropriate place in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 833
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. DESIGNATION OF HOWARD M. METZENBAUM UNITED STATES
COURTHOUSE.
The Federal building courthouse at Public Square and
Superior Avenue in Cleveland, Ohio, shall be known and
designated as the ``Howard M. Metzenbaum United States
Courthouse''.
SEC. 2. REFERENCES.
Any reference in a law, map, regulation, document, paper,
or other record of the United States to the Federal building
courthouse referred to in section 1 shall be deemed to be a
reference to the ``Howard M. Metzenbaum United States
Courthouse''.
______
By Mr. HARKIN (for himself and Mr. Reed):
S. 834. A bill to amend the Public Health Service Act to ensure
adequate research and education regarding the drug DES; to the
Committee on Labor and Human Resources.
the DES Research and Education Amendments of 1997
Mr. HARKIN. Mr. President, today I am pleased to be joined by my
distinguished colleague from Rhode Island, Senator Reed, in introducing
an important women's health initiative. The DES Research and Education
Amendments of 1997 would extend and expand our effort to assist the
over 5 million Americans who have been exposed to
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the drug, DES. Representative Louise Slaughter, a long-time leader on
this issue, is introducing companion legislation today in the other
body.
Between 1938 and 1971, some 5 million American women were given the
synthetic drug, diethylstilbestrol, commonly known as DES. Women were
given the drug during pregnancy in the mistaken belief it would help
prevent miscarriage. The drug was pulled from the market based on
studies that found that it was ineffective and might result in damage
to children born to the women who had been given it.
Since the 1970's, studies have shown that DES does damage the
reproductive systems of those exposed in utero and increases these
individuals' risk for cancer, infertility, and a wide range of other
serious reproductive tract disorders. The women exposed in utero to DES
are five times more likely to have an ectopic pregnancy and three times
more likely to miscarry when they in turn try to have children. Studies
also show that one of every thousand women exposed to DES in utero will
develop clear cell cancer. Women who took DES have also been found to
face a higher risk for breast cancer.
In 1992, while there had been a number of research studies on DES
exposure and its effects, much more research was necessary. That year,
President Bush signed legislation introduced by myself and
Representative Slaughter, that mandated a significant increase in DES
research supported by the National Institutes of Health [NIH]. Our
legislation also required NIH to support long-term studies of Americans
impacted by this drug. Those studies are now underway and must be
continued. The legislation we are introducing today will ensure that
this critical medical research continues. In addition, there is now
preliminary evidence that the grandkids of women who took DES may also
be at higher risk for certain health problems, and this legislation
would help ensure that further research into this is supported.
Another major problem in this area is that millions of Americans
don't know the risks they face because of their exposure to DES. Many
health professionals who see these people also lack sufficient
information about DES exposure and the appropriate steps that should be
taken to identify and assist their patients. As a result, many people
do not seek or get the appropriate preventive care or take appropriate
preventive measures to reduce their risks of adverse affects. For
example, women exposed to DES in utero and therefore at higher risk of
miscarriage may be able to reduce their risks with appropriate
precautionary steps.
In an initial attempt to address this need for better information,
our 1992 legislation required NIH to test ways to educate the public
and health professionals about how to deal with DES exposure. The
legislation we are introducing today would give people across the
Nation access to the information developed through these pilot programs
by requiring a national consumer and health professional education
effort.
Mr. President, we took a very important step in 1992 to begin to
address the significant problem presented by DES exposure. And we did
it with strong bipartisan cooperation between a Democratic Congress and
a Republican President. That legislation expires this year. We need to
make sure that the progress we've made is continued. The 5 million
Americans whose health is at risk are depending on us to work together
to make sure that happens. I urge my colleagues to join me in support
of that effort. I ask unanimous consent that a copy of the legislation
be included in the Record.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 834
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``DES Research and Education
Amendments of 1997''.
SEC. 2. FINDINGS.
With respect to diethylstilbestrol (a drug commonly known
as DES), the Congress finds as follows:
(1) DES was widely prescribed to American women from 1938
to 1971 in the mistaken belief it would prevent miscarriage.
Approximately 5,000,000 pregnant women took the drug,
resulting in DES exposure for approximately 5,000,000
daughters and sons.
(2) Studies conducted since the 1970s have shown that DES
damages the reproductive systems of those exposed in utero
and increases the risk for cancer, infertility, and a wide
range of other serious reproductive tract disorders. These
disorders include a five-fold increased risk for ectopic
pregnancy for DES daughters and a three-fold increase in risk
for miscarriage and preterm labor. Studies have indicated
that exposure to DES may increase the risk for autoimmune
disorders and diseases.
(3) An estimated 1 in 1,000 women exposed to DES in utero
will develop clear cell cancer of the vagina or cervix. While
survival rates for clear cell cancer are over 80 percent when
it is detected early, there is still no effective treatment
for recurrences of this cancer.
(4) Studies also indicate a higher incidence of breast
cancer among mothers who took DES during pregnancy.
(5) While research on DES and its effects has produced
important advances to date, much more remains to be learned.
(6) Preliminary research results indicate that DES exposure
may have a genetic impact on the third generation--the
children of parents exposed to DES in utero--and that
estrogen replacement therapy may not be advisable for DES-
exposed women.
(7) All DES-exposed individuals have special screening and
health care needs, especially during gynecological exams and
pregnancy for DES daughters, who should receive high risk
care.
(8) Many Americans remain unaware of their DES exposure or
ignorant about proper health care and screening. There
remains a great need for a national education effort to
inform both the public and health care providers about the
health effects and proper health care practices for DES-
exposed individuals.
SEC. 3. REVISION AND EXTENSION OF PROGRAM FOR RESEARCH AND
AUTHORIZATION OF NEW NATIONAL PROGRAM OF
EDUCATION REGARDING DRUG DES.
(a) Permanent Extension of General Program.--Section
403A(e) of the Public Health Service Act (42 U.S.C. 283a(e))
is amended by striking ``for each of the fiscal years 1993
through 1996'' and inserting ``for fiscal year 1997 and each
subsequent fiscal year''.
(b) National Program for Education of Health Professionals
and Public.--From amounts appropriated for carrying out
section 403A of the Public Health Service Act (42 U.S.C.
283a), the Secretary of Health and Human Services, acting
through the heads of the appropriate agencies of the Public
Health Service, shall carry out a national program for the
education of health professionals and the public with respect
to the drug diethylstilbestrol (commonly known as DES). To
the extent appropriate, such national program shall use
methodologies developed through the education demonstration
program carried out under such section 403A. In developing
and carrying out the national program, the Secretary shall
consult closely with representatives of nonprofit private
entities that represent individuals who have been exposed to
DES and that have expertise in community-based information
campaigns for the public and for health care providers. The
implementation of the national program shall begin during
fiscal year 1998.
______
By Mr. ABRAHAM (for himself, Mr. McConnell, Mr. Coverdell, Mr.
Santorum, Mr. McCain and Mr. Ashcroft):
S. 836. A bill to offer small businesses certain protections from
litigation excesses; to the Committee on the Judiciary.
The Small Business Lawsuit Abuse Protection Act of 1997
Mr. ABRAHAM. Mr. President, I rise today to introduce the Small
Business Lawsuit Abuse Protection Act of 1997. This bill will provide
targeted relief from litigation excesses to small businesses.
Small businesses in Michigan and across the Nation have faced
increasingly burdensome litigation and desperately need relief from
unwarranted and costly lawsuits. While other sectors of our society and
our economy also need relief from litigation excesses, small businesses
by their very nature are particularly vulnerable to lawsuit abuses and
especially unable to bear the high costs of unjustified and unfair
litigation against them.
As this week is Small Business Week, it provides a fine opportunity
for us to focus on relieving the burdens faced by small businesses.
Small businesses represent the engine of our growing economy and
provide countless benefits to communities across America. The Research
Institute for Small and Emerging Business, for example, has estimated
that there are over 20 million small businesses in America and that
small businesses generate 50 percent of the country's private sector
output.
When I was in Michigan last week over the Memorial Day recess, I
heard story after story from small businesses about the constraints,
limitations, and
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fear imposed on them by the threat of abusive and unwarranted
litigation. I also heard about the high costs that they must pay for
liability insurance. Those represent costs that could be going to
expand small businesses, to provide more jobs, or to offer more
benefits. According to a recent Gallup survey, one out of every five
small businesses decides not to hire more employees, expand its
business, introduce a new product, or improve an existing one out of
fear of lawsuits.
Before the Memorial Day recess, Congress passed the Volunteer
Protection Act, which--if signed by the President--will provide
specific protections from abusive litigation to volunteers. The Senate
passed that legislation by an overwhelming margin of 99 to 1. That
legislation provides a model for further targeted reforms for sectors
that are particularly hard hit and in need of immediate relief.
Small businesses have carried an often unbearable load from
unwarranted and unjustified lawsuits. Data from San Diego's superior
court published by the Washington Legal Foundation revealed that
punitive damages were requested in 41 percent of suits against small
businesses. It is unfathomable that such a large proportion of our
small businesses are engaging in the sort of egregious misconduct that
would warrant a claim of punitive damages. Unfortunately, those sort of
findings are not unusual. The National Federation of Independent
Business has reported that 34 percent of Texas small business owners
have been sued or threatened with court action seeking punitive
damages. Those figures are outrageously high and simply cannot have
anything to do with actual wrongdoing.
We know of far too many examples of expensive and ridiculous legal
threats faced by our small businesses that they must defend every day.
In a case reported by the American Consulting Engineers Council, a
drunk driver had an accident after speeding and bypassing detour signs.
Eight hours after the crash, the driver had a blood alcohol level of
0.09. The driver sued the engineering firm that designed the road, the
contractor, the subcontractor, and the State highway department. Five
years later, and after expending exorbitant amounts on legal fees, the
defendants settled the case for $35,000. The engineering firm--a small
15 person firm--was swamped with over $200,000 in legal costs. That
represents an intolerable amount for a small business to have to pay in
defending a questionable and unwarranted lawsuit.
There are more examples. In an Ann Landers column from October 1995,
a case was reported that involved a minister and his wife who sued a
guide dog school for $160,000 after a blind man who was learning to use
a seeing-eye dog stepped on the woman's toes in a shopping mall. The
guide dog school, Southeastern Guide Dogs, Inc., which provided the
instructor supervising the man, was the only school of its kind in the
Southeast. It trains seeing-eye dogs at no cost to the visually
impaired. The couple filed their lawsuit 13 months after the so-called
accident, in which witnesses reported that the woman did not move out
of the blind man's way because she wanted to see if the dog would walk
around her.
The experiences of a small business in Michigan, the Michigan Furnace
Co., is likewise alarming. The plawsuit in the history of her company
has been a nuisance lawsuit. She indicates that if the money the
company spends on liability insurance and legal fees was distributed
among the employees, it would amount to a $10,000 annual raise per
employee.
These costs are stifling our small businesses and the people who work
there. The straightforward provisions of the Small Business Lawsuit
Abuse Protection Act will provide small businesses with relief by
discouraging abusive litigation. The bill contains essentially two
principal reforms.
First, the bill limits punitive damages that may be awarded against a
small business. In most civil lawsuits against small businesses,
punitive damages would be available against the small business only if
the claimant proves by clear and convincing evidence that the harm was
caused by the small business through at least a conscious, flagrant
indifference to the rights and safety of the claimant. Punitive damages
would also be limited in amount. Punitive damages would be limited to
the lesser of $250,000 or two times the compensatory damages awarded
for the harm. That formulation is exactly the same formulation that
appears in the small business protection provision that was included in
the product liability conference report that passed in the 104th
Congress.
Second, joint and several liability reforms for small businesses are
included under the exact same formulation that was used both in the
Volunteer Protection Act passed this Congress and in the product
liability conference report passed last Congress. Joint and several
liability would be limited so that a small business would be liable for
noneconomic damages only in proportion to the small business's
responsibility for causing the harm. If a small business is responsible
for 100% of an accident, then it will be liable for 100% of noneconomic
damages. But if it is only 70%, 25%, 10%, or any other amount
responsible, then the small business will be liable only for that same
percent of noneconomic damages.
Of course, small businesses would still be jointly and severally
liable for economic damages, and any other defendants in the action
that were not small businesses could be held jointly and severally
liable for all damages. This should provide some protection to small
businesses so that they will not be sought out as ``deep pocket''
defendants by trial lawyers who would otherwise try to get them on the
hook for harms that they have not caused. The fact is that many small
businesses simply do not have deep pockets, and they frequently need
all of their resources just to stay in business, take care of their
employees, and make ends meet.
The other provisions in the bill specify the situations in which
those reforms apply. The bill defines small business as any business
having fewer than 25 employees. That is the same definition of small
business that was included in the Product Liability Conference Report.
Like the Volunteer Protection Act, this bill covers all civil lawsuits
with the exception of suits involving certain types of egregious
conduct. The limitations on liability included in the bill would not
apply to any misconduct that constitutes a crime of violence, act of
international terrorism, hate crime, sexual offense, or civil rights
law violation, or which occurred while the defendant was under the
influence of intoxicating alcohol or any drug.
Also like the Volunteer Protection Act, the bill includes a State
opt-out. A State would be able to opt out of the provisions of the bill
provided the State enacts a law indicating its election to do so and
containing no other provisions. I do not expect that any State will
opt-out of these provisions, but I feel it is important to include one
out of respect for principles of federalism.
I am pleased to have Senators McConnell, Coverdell, Santorum and
McCain as original cosponsors of the legislation and very much
appreciate their support for our small businesses and for meaningful
litigation reforms. The bill is also supported by the National
Federation of Independent Business and by the National Restaurant
Association. I ask unanimous consent that letters from those two
organizations be inserted in the Record.
Finally, I ask unanimous consent that a section-by-section analysis
of the bill be printed in the Record, as well as the full text of the
bill, and I encourage my colleagues to support this simple and much-
needed legislation.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 836
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Small Business Lawsuit Abuse
Protection Act of 1997''.
SEC. 2. FINDINGS.
Congress finds that--
(1) the United States civil justice system is inefficient,
unpredictable, unfair, costly, and impedes competitiveness in
the marketplace for goods, services, business, and employees;
(2) the defects in the civil justice system have a direct
and undesirable effect on interstate commerce by decreasing
the availability of goods and services in commerce;
(3) there is a need to restore rationality, certainty, and
fairness to the legal system;
(4) the spiralling costs of litigation and the magnitude
and unpredictability of punitive
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damage awards and noneconomic damage awards have continued
unabated for at least the past 30 years;
(5) the Supreme Court of the United States has recognized
that a punitive damage award can be unconstitutional if the
award is grossly excessive in relation to the legitimate
interest of the government in the punishment and deterrence
of unlawful conduct;
(6) just as punitive damage awards can be grossly
excessive, so can it be grossly excessive in some
circumstances for a party to be held responsible under the
doctrine of joint and several liability for damages that
party did not cause;
(7) as a result of joint and several liability, entities
including small businesses are often brought into litigation
despite the fact that their conduct may have little or
nothing to do with the accident or transaction giving rise to
the lawsuit, and may therefore face increased and unjust
costs due to the possibility or result of unfair and
disproportionate damage awards;
(8) the costs imposed by the civil justice system on small
businesses are particularly acute, since small businesses
often lack the resources to bear those costs and to challenge
unwarranted lawsuits;
(9) due to high liability costs and unwarranted litigation
costs, small businesses face higher costs in purchasing
insurance through interstate insurance markets to cover their
activities;
(10) liability reform for small businesses will promote the
free flow of goods and services, lessen burdens on interstate
commerce, and decrease litigiousness; and
(11) legislation to address these concerns is an
appropriate exercise of Congress powers under Article I,
section 8, clauses 3, 9, and 18 of the Constitution, and the
fourteenth amendment to the Constitution.
SEC. 3. DEFINITIONS.
In this Act:
(1) Act of international terrorism.--The term ``act of
international terrorism'' has the same meaning as in section
2331 of title 18, United States Code).
(2) Crime of violence.--The term ``crime of violence'' has
the same meaning as in section 16 of title 18, United States
Code.
(3) Drug.--The term ``drug'' means any controlled substance
(as that term is defined in section 102 of the Controlled
Substances Act (21 U.S.C. 802(b)) that was not legally
prescribed for use by the defendant or that was taken by the
defendant other than in accordance with the terms of a
lawfully issued prescription.
(4) Economic loss.--The term ``economic loss'' means any
pecuniary loss resulting from harm (including the loss of
earnings or other benefits related to employment, medical
expense loss, replacement services loss, loss due to death,
burial costs, and loss of business or employment
opportunities) to the extent recovery for such loss is
allowed under applicable State law.
(5) Harm.--The term ``harm'' includes physical,
nonphysical, economic, and noneconomic losses.
(6) Hate crime.--The term ``hate crime'' means a crime
described in section 1(b) of the Hate Crime Statistics Act
(28 U.S.C. 534 note)).
(7) Noneconomic losses.--The term ``noneconomic losses''
means losses for physical and emotional pain, suffering,
inconvenience, physical impairment, mental anguish,
disfigurement, loss of enjoyment of life, loss of society and
companionship, loss of consortium (other than loss of
domestic service), injury to reputation, and all other
nonpecuniary losses of any kind or nature.
(8) Small business.--
(A) In general.--The term ``small business'' means any
unincorporated business, or any partnership, corporation,
association, unit of local government, or organization that
has less than 25 full-time employees.
(B) Calculation of number of employees.--For purposes of
subparagraph (A), the number of employees of a subsidiary of
a wholly-owned corporation includes the employees of--
(i) a parent corporation; and
(ii) any other subsidiary corporation of that parent
corporation.
(10) State.--The term ``State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, any other territory or possession of the
United States, or any political subdivision of any such
State, territory, or possession.
SEC. 4. LIMITATION ON PUNITIVE DAMAGES FOR SMALL BUSINESSES.
(a) General Rule.--Except as provided in section 6, in any
civil action against a small business, punitive damages may,
to the extent permitted by applicable State law, be awarded
against the small business only if the claimant establishes
by clear and convincing evidence that conduct carried out by
that defendant through willful misconduct or with a
conscious, flagrant indifference to the rights or safety of
others was the proximate cause of the harm that is the
subject of the action.
(b) Limitation on Amount.--In any civil action against a
small business, punitive damages shall not exceed the lesser
of--
(1) two times the total amount awarded to the claimant for
economic and noneconomic losses; or
(2) $250,000.
(c) Application by Court.--This section shall be applied by
the court and shall not be disclosed to the jury.
SEC. 5. LIMITATION ON SEVERAL LIABILITY FOR NONECONOMIC LOSS
FOR SMALL BUSINESSES.
(a) General Rule.--Except as provided in section 6, in any
civil action against a small business, the liability of each
defendant that is a small business, or the agent of a small
business, for noneconomic loss shall be determined in
accordance with subsection (b).
(b) Amount of Liability.--
(1) In General.--In any civil action described in
subsection (a)--
(A) each defendant described in that subsection shall be
liable only for the amount of noneconomic loss allocated to
that defendant in direct proportion to the percentage of
responsibility of that defendant (determined in accordance
with paragraph (2)) for the harm to the claimant with respect
to which the defendant is liable; and
(B) the court shall render a separate judgment against each
defendant described in that subsection in an amount
determined pursuant to subparagraph (A).
(2) Percentage of responsibility.--For purposes of
determining the amount of noneconomic loss allocated to a
defendant under this section, the trier of fact shall
determine the percentage of responsibility of each person
responsible for the harm to the claimant, regardless of
whether or not the person is a party to the action.
SEC. 6. EXCEPTIONS TO LIMITATIONS ON LIABILITY.
The limitations on liability under sections 4 and 5 do not
apply to any misconduct of a defendant--
(1) that constitutes--
(A) a crime of violence;
(B) an act of international terrorism; or
(C) a hate crime;
(2) that involves--
(A) a sexual offense, as defined by applicable State law;
or
(B) a violation of a Federal or State civil rights law; or
(3) if the defendant was under the influence (as determined
pursuant to applicable State law) of intoxicating alcohol or
a drug at the time of the misconduct, and the fact that the
defendant was under the influence was the cause of any harm
alleged by the plaintiff in the subject action.
SEC. 7. PREEMPTION AND ELECTION OF STATE NONAPPLICABILITY.
(a) Preemption.--Subject to subsection (b), this Act
preempts the laws of any State to the extent that State laws
are inconsistent with this Act, except that this Act shall
not preempt any State law that provides additional
protections from liability for small businesses.
(b) Election of State Regarding Nonapplicability.--This Act
does not apply to any action in a State court against a small
business in which all parties are citizens of the State, if
the State enacts a statute--
(1) citing the authority of this subsection;
(2) declaring the election of such State that this Act does
not apply as of a date certain to such actions in the State;
and
(3) containing no other provision.
SEC. 8. EFFECTIVE DATE.
(a) In General.--This Act shall take effect 90 days after
the date of enactment of this Act.
(b) Application.--This Act applies to any claim for harm
caused by an act or omission of a small business, if the
claim is filed on or after the effective date of this Act,
without regard to whether the harm that is the subject of the
claim or the conduct that caused the harm occurred before
such effective date.
____
Section-by-Section Analysis--The Small Business Lawsuit Abuse
Protection Act of 1997
section 1. short title
This section provides that the act may be cited as the
``Small Business Lawsuit Abuse Protection Act of 1997.''
section 2. findings
This section sets out congressional findings concerning the
litigation excesses facing small businesses, and the need for
litigation reforms to provide certain protections to small
businesses from abusive litigation.
section 3. definitions
Various terms used in the bill are defined in the section.
Significantly, for purposes of the legislation, a small
business is defined as any business or organization with
fewer than 25 full time employees.
section 4. limitation on punitive damages for small businesses
The bill provides that punitive damages may, to the extent
permitted by applicable State law, be awarded against a
defendant that is a small business only if the claimant
establishes by clear and convincing evidence that conduct
carried out by that defendant with a conscious, flagrant
indifference to the rights or safety of others was the
proximate cause of the harm that is the subject of the
action.
The bill also limits the amount of punitive damages that
may be awarded against a small business. In any civil action
against a small business, punitive damages may not exceed the
lesser of two times the amount awarded to the claimant for
economic and noneconomic losses, or $250,000.
section 5. limitation on several liability for noneconomic loss for
small businesses
This section provides that, in any civil action against a
small business, for each defendant that is a small business,
the liability of that defendant for noneconomic loss will be
in proportion to that defendant's responsibility for causing
the harm. Those defendants would continue, however, to be
held
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jointly and severally l