[Congressional Record Volume 148, Number 68 (Thursday, May 23, 2002)]
[Senate]
[Pages S4772-S4786]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
OF 2002--CONFERENCE REPORT
The PRESIDING OFFICER. Under the previous order, the clerk will
report the conference report.
The assistant legislative clerk read as follows:
The committee of conference on the disagreeing votes of the
two Houses on the amendment of the Senate to the bill (H.R.
3448), to improve the ability of the United States to
prevent, prepare for, and respond to bioterrorism and other
public health emergencies, having met, have agreed that the
House recede from its disagreement to the amendment of the
Senate and agree to the same with an amendment, and the
Senate agree to the same, signed by all conferees on the part
of both Houses.
The Senate proceeded to the consideration of the conference report.
(The conference report is printed in the House proceedings of the
Record of May 21, 2002, on page H2691.)
The PRESIDING OFFICER. Who yields time?
Mr. KENNEDY. Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. REID. Mr. President, I ask unanimous consent the order for the
quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. REID. Mr. President, I ask unanimous consent that the time for
the quorum I suggest be charged evenly to both sides.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. REID. I suggest the absence of a quorum.
The PRESIDING OFFICER. Without objection, the clerk will call the
roll.
The assistant legislative clerk proceeded to call the roll.
Mr. KENNEDY. Mr. President, I ask unanimous consent the order for the
quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. Mr. President, as I understand, there is an hour and a
half evenly divided; am I correct?
The PRESIDING OFFICER. The Senator is correct.
Mr. KENNEDY. I yield myself such time as I might use.
Mr. President, today, the Senate considers historic legislation to
enhance the Nation's preparedness for bioterrorism. This legislation
has benefitted from the leadership of many Members of Congress on both
sides of the aisle and on both sides of the Capitol. I thank all of our
colleagues who have made such important contributions to this
legislation. In particular, I commend my fellow conferees for their
dedicated and effective leadership on this issue in the conference
committee on this legislation. Under the skillful and effective
leadership of our conference chairman, Representative Billy Tauzin, the
conferees and their staffs have worked tirelessly to ensure that this
legislation was completed in a timely manner, and I thank them for
their efforts.
Our conference has reported legislation that will provide a historic
$4.6 billion investment to prepare the Nation to respond effectively to
bioterrorism. This is the single greatest investment our Nation has
ever made in public health.
Many members of the public had never heard of the word
``bioterrorism'' before the anthrax attacks of last fall showed us all
how chillingly vulnerable we are to this new form of terrorist attack.
But bioterrorism was a challenge that our committee had addressed long
before the terrible events of September 11 and the anthrax attacks of
October.
In 1998, my colleague, Senator Bill Frist, and I began to assess the
Nation's preparedness for the new challenge of bioterrorism. We learned
of the terrible loss of life that could result from a major attack
using anthrax, Ebola, smallpox or some other deadly biological weapon.
In the Armed Services Committee, my colleagues and I learned that
biological weapons engineers in the former Soviet Union had conducted
chilling experiments to make these already deadly pathogens yet more
lethal through genetic engineering.
Our committee learned that our Nation's preparedness for the threat
of bioterrorism was dangerously inadequate. Supplies of vaccine against
smallpox were decades old and insufficient to protect the entire US
population. We also learned that more and more germs were becoming
resistant to the antibiotics doctors rely on to treat dangerous
infections. The Nation's public health agencies were underfunded and
understaffed. Rapid communication of information about dangerous
disease outbreaks is an essential part of a national bioterrorism
response yet many public health agencies lacked equipment as basic as a
fax machine or an e-mail account.
To address these grave deficiencies in our Nation's response to
bioterrorism and other public health emergencies, Senator Frist and I--
together with many of our colleagues in the Senate--introduced The
Public Health Threats and Emergencies Act of 2000. Congress approved
this legislation later that year.
The act was the basis for the infusion of needed resources that were
provided to help prepare for bioterrorism in the supplemental
appropriation at the end of last year. I commend my colleagues on the
Appropriations subcommittees, Senator Harkin, Senator Inouye and
Senator Specter, and our distinguished chairman and ranking member of
the Appropriations Committee, Senator Byrd and Senator Stevens, for
their vision and leadership in recognizing the needs of the Nation for
bioterrorism preparedness, and for providing the funds that will help
our Nation prepare for this threat. I look forward to working with
these distinguished colleagues on our supplemental appropriation and on
funding for the initiatives authorized in the conference report for
fiscal year 2003.
I wish I could say that all the deficiencies that Senator Frist and I
learned about in 1998 have been put right. Sadly, I cannot. But we have
made a good start. Public health and laboratory personnel have received
intensive training in identifying biological weapons. The laboratory
technicians who identified the cause of the mysterious illnesses in
Florida as anthrax had recently received such training. Without that
preparation, it is impossible to know how long the anthrax attack would
have gone undetected.
Our legislation authorized rebuilding of CDC's dilapidated and
obsolete facilities in Atlanta. In 1998, we found that the laboratories
and facilities of the CDC were in a shocking state of disrepair.
Ceilings leaked onto sensitive equipment. Offices were scattered across
Atlanta, requiring scientists to spend time fighting traffic when they
should be fighting disease. Our legislation authorizes the funds needed
to complete the CDC's building plan.
No Member of this body has been a more forceful and dedicated
advocate for the CDC than my good friend, Senator Max Cleland. He has
spared no effort in his determination to enhance the ability of CDC to
improve the health of every American. He was one of the original
sponsors of the legislation the Congress enacted 2 years ago to improve
the CDC, and his leadership has been indispensable in including
provisions to enhance CDC in the conference report. His vision and
leadership has enabled CDC to become a magnet for new health care
companies in
[[Page S4773]]
Atlanta, and he has been a guiding force in the development of a new
business park. Through these tireless efforts, CDC has contributed not
only to the Nation's health, but to the economy and prosperity of
Atlanta and the entire State of Georgia. Senator Cleland's leadership
has been instrumental in adding over $300 million for CDC facilities to
the supplemental appropriation.
Public health agencies have received new funds to invest in better
training, improved laboratory equipment and modern communications
technology. Medical researchers are using the tools of this new century
of the life sciences to discover better ways to prevent or cure deadly
infections.
We have come a long way since 1998, but we still have far to go. Too
many communities are still underprepared for bioterrorism. Too many
hospitals--crippled by savage cutbacks in their funding under Medicare
and Medicaid--cannot make the investments needed to prepare for
bioterrorism. Too many Americans are still at risk.
The conference report that the Senate is considering today expands
and extends the legislation approved 2 years ago so that we can build
on the progress we began in 1998.
The keys to responding effectively to a bioterrorist attack lie in
three concepts: detection, treatment, and containment.
Detecting an attack is the key to containing it. Initiatives
authorized in the conference report will improve the training of
doctors to recognize the symptoms of a bioterrorist attack, so that
precious hours will not be lost as doctors try to diagnose their
patients. The report will accelerate development of new methods for
disease surveillance, using modern information technology to provide
real-time reporting of disease outbreaks. The report will also provide
public health laboratories with the training, the equipment, and the
personnel needed to identify biological weapons as quickly as possible.
Once an attack has been identified, we must have adequate medical
supplies to contain it and treat its victims. The conference report
requires the production of enough doses of smallpox vaccine to meet the
needs of every American, so that the Nation will be protected if our
enemies ever unleash this ancient plague. The legislation also enhances
Federal stockpiles of pharmaceuticals, vaccines and other medical
supplies that can be brought to the aid of communities affected by
terrorism, as was done by Secretary Thompson so swiftly and effectively
in the terrible aftermath of the attacks on New York and the Pentagon.
Bioterrorism is a threat to the entire Nation and it demands a
national response. Our legislation authorizes $1.6 billion in grants to
states to enhance bioterrorism preparedness in every state in the
nation. The conference report also sets aside $520 million to enhance
hospital preparedness for bioterrorism. Since bioterrorism will affect
entire communities, our legislation encourages hospital planning to be
integrated with community-wide planning by funding partnerships between
hospitals and state or local governments. Our legislation also includes
a proposal made by my friend, Representative Ed Markey, to provide
needed medications to communities living in the shadow of nuclear power
plants.
The report will enhance preparedness for bioterrorism at the
national, state and local levels. Because of the initiatives we approve
today, American families can go to sleep tonight knowing that their
security will be enhanced.
Title II of the conference report provides important, new protections
against the misuse of dangerous pathogens like anthrax. These
provisions are a decisive step forward for the security of our country.
Once implemented, they will assure greater certainty over the
possession and use of the substances which cause anthrax, plague and
botulism.
Ever since the attacks using anthrax in the fall, our country has
been trying to figure out how this could have happened. And we have
learned that we don't even know who possesses anthrax in the United
States. In response, and through the leadership of Senators Feinstein,
Harkin, and Durbin, we've added significant new authority for the CDC
and the Department of Agriculture to oversee the possession of anthrax
and other dangerous biological agents that could be used to harm our
citizens or agriculture.
Laboratories will now have to register to possess such materials, and
they will have to meet guidelines to ensure the safety and security of
these materials. Individuals who work with these materials in labs will
now be screened to see whether they are terrorists or might otherwise
put the agents to criminal use.
Most importantly, we have enhanced the controls on these materials
while preserving the ability to pursue legitimate research--research
that will produce the treatments, vaccines, and tests that will protect
us from these biological agents, should they ever be used against us.
In light of the anthrax attacks, we have become increasingly
concerned that terrorists could use food as a delivery vehicle for one
of these agents, or that terrorists could attack with biological agents
capable of crippling or destroying our food supply and our agricultural
economy. And so, we have given the FDA more funding and substantial new
authority to protect the food we eat, and the USDA more funding to
enhance the security of the food supply and agribusiness.
I am proud of these accomplishments. In the hands of the FDA, these
provisions will be at work every day to better protect the health and
safety of Americans. They will prevent deliberate attacks on our
country, and they will help reduce our country's epidemic of foodborne
illness. By some estimates, contaminated food in our country causes 76
million illnesses, 325,000 hospitalizations, and 5,000 deaths each and
every year.
For many years, Senators Clinton, Durbin, Mikulski and Reed have
understood this problem and have long championed strong, new food
safety authority and resources for the FDA. Senator Durbin has made
this a top priority throughout his congressional career in both the
House and Senate. For years, Senator Mikulski and I have sought new
authorities over imported foods.
Thanks to the provisions in this legislation, the American public
will greatly benefit from what has been rightly described by the New
York Times as ``the most significant expansion of federal authority
over the food industry in more than six decades.''
FDA will have new authority to prevent unsafe food from entering the
country, new authority to inspect food records and require additional
records to assist in tracing the origins of foodborne illness, and new
authority to register food manufacturers. And we've provided for grants
to States for food inspections and for surveillance and detection of
outbreaks of foodborne illness.
FDA also has more authority to track imported drugs, and authority to
monitor more closely bulk ingredients of drugs, medical devices, and
foods that are imported for export to ensure that these products are
not diverted into domestic commerce.
Just as we have focused attention on securing our Nation's food
supply, Senator Jeffords has led our efforts to secure our Nation's
water supply. Thanks to Senator Jeffords' patient and deliberative
efforts, this legislation will better protect the American public. As
chairman of the Environment and Public Works Committee, our colleague
worked closely with the ranking member, Senator Bob Smith, on
provisions to anticipate and prevent vulnerabilities in our water
supply. Their careful work will fund and enable community water systems
across the country to assess their vulnerabilities, address immediate
and urgent security needs, and carefully plan for potential terrorist
attack.
I am also happy to note that the conference report includes S. 1275,
``The Community Access to Emergency Defibrillation Act'' authored by
myself and Senator Frist. This important legislation has the
demonstrated potential to save two of thousands of lives annually and
is strongly endorsed by the American Heart Association.
I am very pleased we have reauthorized the Prescription Drug User Fee
Act, PDUFA, for the second time. When I authored the Prescription Drug
User Fee Act of 1992 with Congressmen Dingell and Waxman and Senator
Hatch, I hoped this law would provide urgently needed funds to the Food
and Drug Administration to speed the review of new drugs. Before user
fees
[[Page S4774]]
were enacted, FDA was short staffed and underfunded. Every beneficial
drug delayed because FDA had insufficient staff to act promptly
represented a therapeutic opportunity denied to patients and consumers.
The past decade has more than fulfilled my hopes and expectations.
The FDA has done a remarkable job of reviewing new drugs in a rapid but
deliberative manner. Patients have benefitted from the agency's
dramatic success in speeding drug reviews, and this legislation
promises to continue this track record of success.
At the same time that speedier approvals have benefitted patients,
there have been growing concerns over whether faster speed to market
for drugs has come with heightened risks to patients. The fact that
more new drugs have reached American consumers first in the world means
they are also the first to be exposed to new risks and new safety
concerns. A recent Pulitzer Prize-winning investigation by David
Willman of the Los Angeles Times documented the urgent need to balance
rapid approval of drugs with an equal commitment to assuring safety.
This concern is substantiated by a recent General Accounting Office
study which I requested on the user fee program. According to GAO, the
proportion of safety-related drug withdrawals has increased for drugs
approved under PDUFA II compared to drugs approved under the first
PDUFA. While only 1.6 percent of drugs approved from 1993 through 1996
were withdrawn for safety reasons, over 5 percent of drugs approved
from 1997 through 2000 were withdrawn due to safety. While the number
of drugs involved is still small only seven in the latter period
compared to two in the earlier period--this report is still an
important caution and a substantial increase in our investment in drug
safety is warranted.
These are the issues I have shared and discussed for years with
patient advocates, consumer groups and independent scientists. And for
many years, I have made clear that we must restore public confidence in
the FDA's stewardship of prescription drugs. Our dramatic investments
in drug reviews had to be matched by a corresponding renewal of effort
in post-marketing surveillance and drug safety. Anything less would
only serve to cast doubts on the integrity of FDA's regulation of drug
safety.
In the past year, our committee, including Senators Reed, Clinton,
Bingaman, Mikulski, Harkin, Dodd, and Edwards, worked closely with the
Patient and Consumer Coalition and with independent drug safety experts
to develop solutions. We found that our concerns were shared by our
colleagues in the House, including Congressmen Dingell, Brown, Waxman
and Stupak. Throughout congressional deliberations on the
reauthorization of prescription drug user fees, we agreed upon the need
for additional resources and stronger authorities for FDA. While it is
important for us to bring drugs to market quickly, we agreed that this
redoubles our obligation to assure the safety of those drugs.
Today, I am happy to say that is precisely what we have accomplished
in this legislation.
First, the FDA's performance goals relating to the speed of approval
have not changed. The many review staff hired by FDA with user fees can
continue to scrutinize the safety of drugs seeking approval. The
increased fees in the new agreement will be used not to further
accelerate the approval of drugs, which is already the fastest in the
world, but to assure that the studies underlying drug applications are
given the most careful possible scrutiny to assure that the drugs are
in fact safe and effective.
The public and my colleagues in the Senate should also understand
that the performance goals contained in all of the PDUFA agreements are
not goals for the approval of new drugs; rather they are goals for the
timely review of new drugs. FDA meets these goals whether or not the
agency approves or denies approval of a drug.
Best of all, I want my colleagues to know that this reauthorization
is a tremendous accomplishment where drug safety is concerned. We will
increase FDA's drug safety spending by over 80 percent over the life of
this user fee agreement. With FDA's annual drug safety activities
currently funded at $36 million, this legislation will ensure an
increase of $29 million in the fifth year of this agreement, for a
total of $65 million in annual drug safety funding at FDA.
To achieve this goal, we have made a fundamental change to how user
fees are used. The user fee agreement includes a dramatic funding
increase of $76 million over five years for FDA to plan, execute and
fund drug safety ``risk management'' activities for newly marketed
drugs. While these activities would be limited in scope and duration,
FDA will be able to greatly expand its focused scrutiny of these drugs.
But in order to give FDA greater freedom of action, we have also
mandated substantial funding increases for the agency's Office of Drug
Safety. In fiscal year 2003, the Office will receive an additional $5
million, and an additional $10 million in fiscal year 2004, with
increases assured in subsequent years. Since these funds will be drawn
from FDA's appropriations, Congressman Tauzin, my fellow conferees and
I are committed to doing all that is necessary to ensure that these are
new funds and will not be cannibalized from FDA's other essential
programs and activities.
We have made other important steps to advance public health and
safety. In response to the explosion of direct-to-consumer drug
advertising, we have authorized an additional $27 million over five
years for FDA's scrutiny of drug advertising and promotions. In
response to delays in generic drug approvals, some of which arise from
anti-competitive practices by the brand-name drug industry, we have
authorized an additional $45 million over five years for FDA's Office
of Generic Drugs to ensure that generic drugs reach the public more
quickly.
We have also squarely addressed a persistent problem with the
prescription drug industry. For years, drug companies would promise to
complete post-market, or phase IV, clinical trials to answer important
questions about their products. These commitments paved the way for
reaching the market earlier. In the case of fast track drugs and drugs
approved through the accelerated approval, these trials were mandatory.
Yet many companies have failed to begin or complete these trials. And
to respond, FDA's only--and usually unacceptable--recourse would be to
withdraw a drug for market.
The industry's track record has been disappointing. According to the
FDA, since 1998, only four of 109 post-market commitments have been
fulfilled for fast track drugs. Only a quarter of the industry's
commitments for standard drugs since 1991 have been fulfilled. And only
a third of its commitments for accelerated approval drugs since 1992
have been fulfilled.
Five years ago, I urged the adoption of new authorities for FDA to
enable the agency to bring these companies into compliance with the law
and to ensure these essential trials are conducted in a timely way. I
am very pleased that this legislation includes new authority for the
FDA to publicize the failure of companies to fulfill their legal
obligations to complete post-market studies. FDA will publicize such
failures through their website, through `dear prescriber' letters, and
public statements on the late, uncompleted studies and the resulting,
unanswered questions of clinical benefit and safety. I am hopeful that
the FDA will be able to employ these new tools to bring about more
responsible conduct by the industry, and consequently resolve
unresolved questions of drug safety and efficacy.
I am disappointed that some of my colleagues objected to addressing
in this legislation a crucial priority for children's health. The FDA
has a Pediatric Rule that requires a company, before approval of a
drug, to study in children the use for which approval is sought in
adults. It also gives FDA the authority to require, in certain
circumstances, that drugs that are already marketed be studied for
their approved use in children. The Pediatric Rule has always served as
a complement to pediatric exclusivity, which we recently reauthorized
in the Best Pharmaceuticals for Children Act.
But today, the Rule is being challenged in court by parties who
believe the drug industry should be free to decide when or whether to
determine their drugs are safe and effective for
[[Page S4775]]
children. The Rule was recently threatened with withdrawal, but the
Administration reconsidered this ill-advised step.
That is why a clear signal must be sent. This research is of critical
importance to children. Without the Rule, less of this research will be
conducted. And some products, such as biologicals, will not be studied
at all.
With my colleagues, Senators Clinton, Dodd and DeWine, I intend to
pursue this issue in the coming months. We cannot afford to compromise
the health of our children with half measures.
Finally, I am disappointed that we could not reach agreement on
legislation enacting medical device user fees. In 1994, I introduced
such legislation with Congressmen Dingell and Waxman. But dissension
within the device industry prevented us from enacting this important
reform. Since then, the FDA Center for Devices and Radiological Health
and suffered severe losses in its budget and staffing. Its staff has
shrunk by almost eight percent since 1995 and it has effectively lost
more than $34 million in its base funding.
With support of my colleague, Senator Gregg, we urged the FDA and the
device industry to seek agreement on performance goals and fees. And to
their great credit, the FDA and the industry reached agreement. But
some in the device industry insisted on including extraneous proposals
that could not be worked out in the limited time available.
Medical device user fees are a win for patients, the industry and the
FDA. That is why I am committed to achieving a consensus on this issue.
I believe that we can enact such legislation, so long as we can
dispense with extraneous controversies and focus on the common goals of
restoring the resources of FDA's device center, establishing reasonable
performance goals for device reviews, and assuring that safe and
effective devices are approved in a more timely manner.
The timely completion of the conference report would not have been
possible without the hard work of the many staff members who worked on
this important legislation. I particularly want to thank Bill Baird of
Senate Legislative Counsel and Pete Goodloe of House Legislative
Counsel. Both of these dedicated professionals worked many long, late
hours and met many tight deadlines to allow this report to be
completed.
I want to also thank Patrick Morrissey, Tom DiLenge, Brent Delmonte,
Amit Sachdev, Bob Meyers and Nandan Kenkeremath from Congressman
Tauzin's staff; Katy French, Vince Ventimiglia, and Steve Irizarry from
Senator Gregg's staff; Adam Gluck, Eric Juzenas, and Lowell Ungar with
Senator Harkin; Rhonda Richards with Senator Mikulski; Alison Taylor,
Jo-Ellen Darcy, and Sean Donohue with Senator Jeffords; Deb Barrett and
Jim Fenton with Senator Dodd; Shana Christrup, Helen Rhee and Dean
Rosen from Senator Frist's staff; John Ford, David Nelson, Edith
Holleman, Bridgett Taylor and Dick Frandsen from Congressman Dingell's
staff; Karen Nelson, Ann Witt and Greg Dotson with Congressman Waxman.
On my own staff, I want to thank David Bowen for his outstanding work
on all aspects of the bioterrorism issue. He has been tireless and
insightful and I know everyone involved in this effort appreciates his
work.
I also want to thank Paul Kim and David Dorsey for their
extraordinary efforts to assure protection of our food and water
supply, as well as providing better security for potentially dangerous
bio-materials in our nation's laboratories. They also worked very hard
to assure that the Prescription Drug User Fee Agreement was a step
forward for every patient in this country.
David Nexon, my Health Staff Director, brought his usual energy and
commitment to the effort. Michael Myers, the Health, Education, Labor,
and Pension Committee Staff Director, kept his hand on the tiller
throughout.
The conference report is a landmark in our national response to
terrorism and the security threats of this new century. Congress today
sends the message in one unified and clear voice that this nation will
not remain unprepared for the threat of bioterrorism. The front lines
in the new war against bioterrorism will be our health care system.
Today we take a historic step forward in preparing America's health
care professionals to win the war against bioterrorism.
Amendment No. 3462, As Modified
Mr. KENNEDY. Mr. President, I ask unanimous consent that the Corzine
amendment No. 3462 be modified with the language at the desk; further,
that the amendment be agreed to, and the motion to reconsider be laid
upon the table.
The PRESIDING OFFICER (Mr. Carper). Is there objection? Without
objection, it is so ordered.
The amendment (No. 3462), as modified, is as follows:
Beginning on page 208, beginning on line 4, strike all
through page 211, line 19, and insert the following:
SEC. 1143. BORDER SEARCH AUTHORITY FOR CERTAIN CONTRABAND IN
OUTBOUND MAIL.
(a) In General.--The Tariff Act of 1930 is amended by
inserting after section 582 the following:
``SEC. 583. EXAMINATION OF OUTBOUND MAIL.
``(a) Examination.--
``(1) In general.--For purposes of ensuring compliance with
the Customs laws of the United States and other laws enforced
by the Customs Service, including the provisions of law
described in paragraph (2), a Customs officer may, subject to
the provisions of this section, stop and search at the
border, without a search warrant, mail of domestic origin
transmitted for export by the United States Postal Service
and foreign mail transiting the United States that is being
imported or exported by the United States Postal Service.
``(2) Provisions of law described.--The provisions of law
described in this paragraph are the following:
``(A) Section 5316 of title 31, United States Code
(relating to reports on exporting and importing monetary
instruments).
``(B) Sections 1461, 1463, 1465, and 1466, and chapter 110
of title 18, United States Code (relating to obscenity and
child pornography).
``(C) Section 1003 of the Controlled Substances Import and
Export Act (relating to exportation of controlled substances)
(21 U.S.C. 953).
``(D) The Export Administration Act of 1979 (50 U.S.C. App.
2401 et seq.).
``(E) Section 38 of the Arms Export Control Act (22 U.S.C.
2778).
``(F) The International Emergency Economic Powers Act (50
U.S.C. 1701 et seq.).
``(b) Search of Mail Not Sealed Against Inspection and
Other Mail.--Mail not sealed against inspection under the
postal laws and regulations of the United States, mail which
bears a Customs declaration, and mail with respect to which
the sender or addressee has consented in writing to search,
may be searched by a Customs officer.
``(c) Search of Mail Sealed Against Inspection Weighing in
Excess of 16 Ounces.--
``(1) In general.--Mail weighing in excess of 16 ounces
sealed against inspection under the postal laws and
regulations of the United States may be searched by a Customs
officer, subject to paragraph (2), if there is reasonable
cause to suspect that such mail contains one or more of the
following:
``(A) Monetary instruments, as defined in section 1956 of
title 18, United States Code.
``(B) A weapon of mass destruction, as defined in section
2332a(b) of title 18, United States Code.
``(C) A drug or other substance listed in schedule I, II,
III, or IV in section 202 of the Controlled Substances Act
(21 U.S.C. 812).
``(D) National defense and related information transmitted
in violation of any of sections 793 through 798 of title 18,
United States Code.
``(E) Merchandise mailed in violation of section 1715 or
1716 of title 18, United States Code.
``(F) Merchandise mailed in violation of any provision of
chapter 71 (relating to obscenity) or chapter 110 (relating
to sexual exploitation and other abuse of children) of title
18, United States Code.
``(G) Merchandise mailed in violation of the Export
Administration Act of 1979 (50 U.S.C. App. 2401 et seq.).
``(H) Merchandise mailed in violation of section 38 of the
Arms Export Control Act (22 U.S.C. 2778).
``(I) Merchandise mailed in violation of the International
Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).
``(J) Merchandise mailed in violation of the Trading with
the Enemy Act (50 U.S.C. App. 1 et seq.).
``(K) Merchandise subject to any other law enforced by the
Customs Service.
``(2) Limitation.--No person acting under the authority of
paragraph (1) shall read, or authorize any other person to
read, any correspondence contained in mail sealed against
inspection unless prior to so reading--
``(A) a search warrant has been issued pursuant to rule 41
of the Federal Rules of Criminal Procedure; or
``(B) the sender or addressee has given written
authorization for such reading.
``(d) Search of Mail Sealed Against Inspection Weighing 16
Ounces or Less.--Notwithstanding any other provision of this
section, subsection (a)(1) shall not apply to mail weighing
16 ounces or less sealed against inspection under the postal
laws and regulations of the United States.''.
[[Page S4776]]
(b) Certification by Secretary.--Not later than 3 months
after the date of enactment of this section, the Secretary of
State shall determine whether the application of section 583
of the Tariff Act of 1930 to foreign mail transiting the
United States that is imported or exported by the United
States Postal Service is being handled in a manner consistent
with international law and any international obligation of
the United States. Section 583 of such Act shall not apply to
such foreign mail unless the Secretary certifies to Congress
that the application of such section 583 is consistent with
international law and any international obligation of the
United States.
(c) Effective Date.--
(1) In general.--Except as provided in paragraph (2), this
section and the amendments made by this section shall take
effect on the date of enactment of this Act.
(2) Certification with respect to foreign mail.--The
provisions of section 583 of the Tariff Act of 1930 relating
to foreign mail transiting the United States that is imported
or exported by the United States Postal Service shall not
take effect until the Secretary of State certifies to
Congress, pursuant to subsection (b), that the application of
such section 583 is consistent with international law and any
international obligation of the United States.
The PRESIDING OFFICER. The Senator from New Hampshire.
Mr. GREGG. Mr. President, I thank the Senator from Massachusetts for
his exceptional leadership on this piece of legislation, along with the
many members of the committee I have worked with and about whom I will
talk later on as I discuss the implications of this piece of
legislation. Also, I thank our House colleagues who produced an
excellent bill on their own. As a result, we were able to merge the
best of the two which, I believe, produce a superb package, although
lacking in a couple of items, as alluded to by the chairman of the
committee.
It is basically an extremely positive package, and it puts us well
down the road to addressing what is clearly one of the most threatening
situations we have as a society, and that is the capacity of those who
wish us ill--and, regrettably, there are a number of people and
organizations in this world who wish us ill and would use weapons of
mass destruction against us, which would include biological warfare.
We saw, of course, the devastating impact of a biological event with
the anthrax incident, and the President has been speaking about this as
he has been moving through Europe on his trip, that some nations in
this world are continuing to develop biological weapons and may be
making those weapons available to terrorists.
We as a nation, whether we like it or not, have to get ready to
confront this threat. This bill will do a great deal to put us in a
position to accomplish that.
The bill is structured around a variety of points, and I will go into
them in specific detail, but the concept of the bill is basically to
significantly improve our Federal capability to deal with a biological
event and prepare ourselves with adequate vaccines and adequate
research in the area of developing vaccines to confront bioterrorism
and, at the same time, look to the local communities and the States and
significantly improve the public health capability of the States and
the local communities so that they, as the first responders, will be
able to manage an event should the worst occur, and we will be able to
deal with it in an effective and prompt way.
The bill makes a significant commitment of resources well beyond what
we had anticipated making when we started down this road but which are
necessary. In this war on terrorism, we cannot look at pricetags, we
must look at results. It is going to cost a great deal to accomplish
the results we need.
This bill, although long-awaited, will definitely better prepare this
Nation to respond to attacks which use biological, chemical, or other
weapons of mass destruction.
The bill provides grants to States and local public health agencies
to assist in preparing for a biological terrorist attack. With these
resources, unlike prior law, even small States such as New Hampshire
are assured the ability to prepare and respond to a bioterrorist attack
or other public health emergency.
Because of the importance of State preparedness and the amount of
resources that have been provided, I intend to play an active role in
making sure these funds are not just received by hospitals and State
and local governments but that they are well spent for the benefit of
the American citizenry.
An important part of this bill is ensuring that the funds are spent
consistent with a State's bioterrorism plans. In addition, we have
already begun oversight of the program and look forward to working with
the administration and grant recipients as work under the grants begins
in earnest.
Further, under section 102, we will help ensure effective
communication and cooperation among the State, local, and Federal
agencies by creating a new Assistant Secretary for Public Health
Emergency Preparedness at HHS.
Also, the volunteer spirit has always been alive and well, especially
in New Hampshire, and I am pleased this conference report includes
several provisions which are designed to facilitate voluntarism in
preparing for public health emergencies and especially bioterrorism
emergencies.
Title I also includes a number of provisions intended to further
speed lifesaving products to citizens before we are faced with another
serious threat of bioterrorism.
Section 121 ensures that stockpiles of products are improved
immediately so that there is an adequate supply to protect our citizens
from bioterrorism and other threats. This year we provided the funding
necessary to fulfill this commitment, and the Secretary is directed to
improve not just the stockpile contents but the supply chain management
of and local access to products.
The bill improves the Secretary's authority to, one, prioritize and
do research on new vaccines and therapies; two, rely on all available
forms of proof of safety and effectiveness, including animal trials;
and three, accelerate approval of these products. This is absolutely
critical if we are to be prepared with adequate vaccines to make sure
our citizenry is protected.
Title II includes the expanded Gregg-Feinstein provisions initially
passed by the Senate late last year as part of the appropriations
legislation.
As the recent anthrax attack has suggested, current authorities have
been inadequate to ensure the Government can track the use of
biological agents and toxins such as anthrax and botulinum toxins, West
Nile virus, and the like, and to protect against their misuse.
The bill makes critical improvements in the Secretary's ability to
identify who is handling and doing research with these agents and
toxins, to ensure they are qualified to handle these agents, and to
ensure they are not restricted due to inappropriate background or
current intent.
The bill also ensures that universities, laboratories, and agencies
working with these agents are registered, appropriately qualified, and
have adequate security in place.
Many of these agents are used in important research or for important
therapeutic purposes in animals and humans. These uses must remain
protected and promoted even as we protect the public from their misuse.
The bill ensures important exemptions, for example, for FDA-approved
products using or investigating these agents or toxins.
Title III of the bill provides the FDA with additional inspection,
recordkeeping, and detainment authority to ensure the safety of
America's food and drug supply and increases the number of FDA food
inspectors. Senator Kennedy spoke about this at some length.
The bill also improves our capacity to prevent, detect, and respond
to an attack on American farmers, livestock, and poultry producers, and
certainly Senator Roberts deserves great credit for that. I know he is
going to be speaking in a few minutes.
Finally, it provides funds to community drinking water systems to
allow them to assess any possible vulnerabilities and to institute
measures to prevent tampering. Many have been concerned about having
these vulnerability studies go to the EPA which does not have a solid
track record of maintaining control over sensitive information. We must
ensure that the EPA allocates resources and institutes procedures
designed to prevent this information from falling into the wrong hands.
It would do no good for us to develop these studies and then find that
terrorists had been able to use these studies against us.
[[Page S4777]]
Conferees also succeeded in reauthorizing PDUFA, which has already
been mentioned by the chairman, which has so successfully ensured
patients timely access to safe, effective, and lifesaving drugs. By
collecting fees from pharmaceutical companies, FDA can hire additional
reviewers and support staff and speed the drug review process without
compromising safety or review quality.
Under the agreement, the amount of funding FDA receives under the
program will increase by over 28 percent, and in today's deficit
environment this will be of significant assistance. Voluntary user fees
are substantial and essential sources of revenue that the agency cannot
afford to lose.
I am concerned, however, that this bill does not include some of the
following items that are particularly critical to the ability of this
country to rapidly prepare for, detect, or respond to biological
threats, including anthrax, smallpox, and botulism.
In the antitrust area, the Senate bill included a bipartisan
consensus provision supported by the Judiciary Committee that would
extend protection to manufacturers of vaccines and their therapies for
bioterrorism agents when the companies were engaged in discussions with
the Secretary over how best to meet the unmet needs of the United
States.
It is critical these companies be able to discuss frankly with the
Secretary their capacities and their strengths so that they can have
rapid research and develop new vaccines and drugs that protect us
against bioterrorism acts. This provision was, regrettably, dropped in
conference over my strong objection. I will continue to press for it in
other arenas.
In many critical respects, this Nation remains unprepared for
bioterrorism threats simply because the threat of unreasonable and
abusive lawsuits has kept good ideas and good products from being
available to our citizens. Examples include decontamination services
and cleanup services for contaminated worksites, unavailable because of
a threat a lawyer might sue the company.
Lifesaving vaccines also remain undeveloped for these same reasons.
Respirator manufacturers risk the threat of suit when volunteers misuse
a mask in the midst of the chaos during a crisis.
I intend to work for a solution this year with many of my colleagues
who have expressed support for reasonable liability protections so we
can bring on to the market the necessary devices and vaccines in order
to address these needs and make sure our marketplace is able to respond
effectively to the threat.
Finally, I note my disappointment that the final package did not
include critical new user fee programs for the FDA's device on animal
drug centers and accompanying reforms that would dramatically improve
regulation of those products. These programs and reforms are essential
to ensuring that our Nation continues to be the leader in developing
lifesaving therapies and technologies.
However, I am heartened by the extraordinary bipartisan, bicameral
support demonstrated for those provisions during the conference. I look
forward to working with my colleagues, particularly Senator Dodd,
Senator Hutchinson, and Senator Kennedy, in the development of a strong
user fee and reform package. I understand the House intends to move
this separately, and certainly I hope we will be able to do the same in
the Senate.
There are a lot of people who worked very hard on this bill to make
it a success. Certainly Senator Kennedy was a leader, and he is to be
congratulated for his foresight in this matter. Senator Frist, whose
knowledge in this area is unique and brings so much to the table in the
Senate, was a major player in designing much of this bill; Senator Enzi
and Senator Tim Hutchinson for their critical role in ensuring the
capacity of all States, but especially rural States, to have capacity
to prepare for attacks. Senator Susan Collins played a critical role in
developing the Senate food supply safety provisions, a role reflected
in a long history working to pass such legislation. Senator Hutchinson
also played the single most critical role in the provision protecting
America's agricultural livestock and poultry provisions. His animal
enterprise provision, which will protect our folks working on the next
generation of lifesaving vaccines and medicines, is absolutely
essential.
I am also pleased with the inclusion in this bill of so much of
Senator Hutchinson's legislation concerning improvement in the ability
to bring antibioterrorism products to the American citizen; Senator
Sessions for his tremendous effort with regard to the minor use, minor
species provisions, which would have provided safe and effective drugs
for minor animal species for which therapies are currently unavailable.
Unfortunately, this provision was not included in the final bill, but
it is sound policy and I will continue to support his efforts and to
pass this legislation; Senator Roberts whose attention to the issue of
farm policy and the effect of bioterrorism issues relative to our farm
community was absolutely critical to the design of this bill.
At a staff level, I have an exceptional staff. They have worked
thousands of hours, days and nights, and I thank them very much. Vince
Ventimiglia, Steve Irizarry, and Katy French did a superb job. I also
thank the majority staff led by David Nixon, and the many people he has
working with him. Also, I thank Dean Rosen on Senator Frist's staff.
I yield 10 minutes to the Senator from Kansas, Mr. Roberts.
The PRESIDING OFFICER. The Senator from Kansas is recognized.
Mr. ROBERTS. I thank the Senator for yielding. The completion of the
Bioterrorism Preparedness Act conference report, in my view, represents
an absolutely vital and significant step forward for our Nation as we
work to protect ourselves from any kind of a terrorist attack involving
bioterrorism.
I also had the privilege of being chairman and now ranking member of
the Emerging Threats Subcommittee of the Armed Services Committee. We
had witness after witness and commission after commission. We asked
them: What keeps you up at night? Each and every time when we tried to
prioritize the threat that faced this country, bioterrorism was listed
as No. 1.
I thank Senator Kennedy for his leadership with regard to this bill.
I echo the comments by Senator Gregg, who has been extremely helpful
and led the effort on our side. I especially thank Senator Frist whose
expertise and leadership with the Centers for Disease Control and the
Department of Health and Human Services, plus his personal expertise,
is second to none. If he is not the godfather of this bill, he is
indeed the godprince. So I thank him for those efforts.
This bill also represents a significant advancement in helping to
protect agriculture and our Nation's food supply from a possible
agroterrorist attack. The legislation contains language based on
numerous provisions I introduced in the bill some time ago. It was
called the Biosecurity for Agriculture Act. I think that was last fall.
Specifically, the bill provides funding authorization for $190
million for expanded agroterrorism research in 2002 and such sums as
necessary in the future years.
This language will allow us to significantly expand our research
capabilities to deal with these threats. It will allow us to expand
existing research partnerships between the Department of Agriculture
and many of our land grant universities to develop first-responder
capability in case we have an agroterrorist attack. It is going to
create many additional partnerships. It will increase the coordination
between the Department of Agriculture and the intelligence community,
and undertake research to develop what we call rapid field test kits
that will allow us to make a determination of the possible introduction
of any pathogen or disease within minutes or hours instead of days or
weeks, as often occurs, as of today.
In addition, the bill also includes language similar to that I
introduced to authorize funding for the upgrades of the Department of
Agriculture research facilities at Plum Island, NY, Ames, IA, Laramie,
WY, and Athens, GA. These facilities really represent the frontline in
the Department of Agriculture's research efforts to prevent disease
outbreaks in the United States.
Why is the inclusion of this provision in this particular bill so
important? I am not aware of any specific threat, but the possibility
of agroterrorism or
[[Page S4778]]
food security attacks is very real, and it has increased since
September 11.
Second, we know the former Soviet Union had developed literally tons
of biowarfare agents that were to be aimed at the North American food
supply. Many of these agents are still housed in unsecured facilities.
I have been there. Senator Lugar has been there. Many of the scientists
are simply unemployed and are willing to work for the highest bidder,
and that is a grave concern.
Third, we know several of the September 11 hijackers had significant
agricultural training. It would be very easy to introduce a disease
such as foot and mouth disease or Karnal Bunt, and the effects would be
devastating to our grain supply and our livestock production. Our
exports would be lost and consumer confidence would simply plummet.
Food shortages would occur in our Nation's cities.
This is particularly frightening when we realize that agriculture is
one of the few sectors of the economy with a trade surplus. Using 1999
numbers, agriculture and agribusiness-related industries accounted for
approximately 22 million jobs, almost 17 percent of the gross domestic
product. The overall contribution to the Nation's GDP in 1999 was $1.5
trillion. That is at risk. And the cheap U.S. food supply kept the
total portion of the individual income spent on food to about a dime or
10 percent--one dime out of the consumer's disposal income dollar for
that so-called market basket of food. A terrorist attack would
certainly endanger that.
The importance of this sector to our economy, and our national
security, cannot be underestimated. We must take the steps to protect
our agricultural producers, our farmers, our ranchers, and our food
supply. This bill represents a very important step.
I thank my colleagues who have worked with me on this issue. I thank
the staff of the HELP Committee in working with my staff and those on
the Agriculture Committee. I thank them for their assistance, including
these provisions in this legislation.
I yield back the remainder of my allotted time.
The PRESIDING OFFICER. The Senator from Tennessee.
Mr. FRIST. Mr. President, we have learned a lot about terrorism since
September of last year. We have learned that terrorists prey on
vulnerability. Our vulnerability becomes their target. This bill
reduces our vulnerability when it comes to this threat of bioterrorism
and thus reduces the likelihood of an attack by reducing our
vulnerability and reduces the potential damage an attack may cause by
improving and strengthening our response.
We have learned the goal of a bioterror attack is not only to hurt
people directly but to paralyze them, to cause panic. This bill will
calm the nerves and keep order in the event there is another bioterror
attack.
This bill addresses prevention and preparedness, as well as response.
Indeed, this bill touches all areas of preparedness: Protecting our
food and water, boosting medical stockpiles, and supporting our local
communities and public health infrastructure.
This bill emphasizes the local response and local preparedness. It
recognizes that it is local people who will respond in the event of a
bioterror attack. It is about whom you call when you suspect something,
whom you call if you are worried about bioterrorism: The family
doctors, the emergency workers, the health care professionals. Today,
with this legislation we make the first people on the scene our first
priority.
Over 3 months after the tragedies of September 11 and slightly more
than 60 days after the anthrax attacks, Congress provided a record $3
billion in emergency bioterrorism funding. This was in December of last
year. This was a historic investment. As we have learned since that
time, it must be only a downpayment toward ensuring that America is
fully prepared to respond to bioterrorism and other public health
risks.
Today, we take another important and very necessary step toward
securing our Nation with the Public Health Security and Bioterrorism
Preparedness and Response Act. It is a cohesive and comprehensive
framework to improve our public health system and thereby reduce our
vulnerability.
I, too, thank Senator Kennedy and Senator Gregg for their leadership
and their tremendous contributions to this conference report. I thank
our colleagues in the House of Representatives, primarily Chairman
Tauzin and Representative Dingell, for their huge and important
efforts. Yesterday's overwhelming vote in the House in favor of passing
this conference agreement demonstrates this legislation is truly broad
and bipartisan.
There is no question we live today in a more dangerous world, much
more dangerous than we envisioned before September 11, much more
dangerous than we had envisioned before the anthrax-laden letters were
delivered across the east coast. We are not unprepared for a bioterror
attack, but we are clearly underprepared. This bill goes a long way in
boosting that preparedness and reducing the vulnerabilities.
We know terrorists around the world, including al-Qaida, are intent
on using biological weapons against us. We know more than a dozen
nations--including Iraq, North Korea, Libya, Syria--have the capability
to produce chemical and biological weapons, and many have stockpiled
such biological weapons in the past. We know thousands of Soviet
scientists who have the expertise to develop biological weapons are,
today, unemployed, and potentially available to the highest bidder.
Yes, the risk is real. We know the risk is increasing. The National
Intelligence Council warns:
The biological warfare capabilities of state and non-state
actors are growing worldwide. This trend leads us to believe
that the risk of an attack against the United States, its
interests and allies will increase in the coming years.
This bill is the foundation and framework for our response.
Iraq launched a robust biological program in 1985 and has admitted to
producing large quantities of agents and weapons, including 19,000
liters of botulinum--in fact, 10,000 liters loaded into munitions--and
8,500 liters of anthrax--and 6,500 were loaded into munitions. During
the gulf war, Iraq weaponized 100 bombs and 15 missile warheads with
botulinum, and 50 bombs and 10 missile warheads with anthrax.
Nonstate actors are also a threat. CIA Director George Tenet has been
quoted recently in the New York Times as saying: Documents recovered
from al-Qaida facilities in Afghanistan show that Osama bin Laden was
pursuing a sophisticated biological weapons research program. U.S.
forces discovered a facility in southern Afghanistan near Kandahar that
was being built to produce biological agents.
Our vulnerabilities remain high. This bill addresses reducing those
vulnerabilities. Most public health departments in the United States do
not have staff fully trained in bioterrorism. A recent report showed
that one-third of public health departments serving 25,000 or fewer
people had no Internet access, and one-quarter of public health staff
had no electronic or e-mail. Today more than 99 percent of food
imported into this country is never inspected.
The American people, with passage of this legislation, should rest
easier, knowing that our Government is taking the steps necessary to
respond to this threat at the local level, at the State level, and at
the national level. This legislation will ensure that we continue to
act both rapidly and appropriately to secure the Nation against future
attacks on our freedom.
What does the bill do? The conference agreement provides the
resources necessary to improve the training of those first responders,
to those doctors, to nurses, to public health officials at the local
level. They are the first line of defense. The bill authorizes $300
million both in 2002 and 2003 to strengthen the capabilities of the
Centers for Disease Control and Prevention and modernize its
facilities. The bill enhances our national research capabilities and
helps speed the development of needed drugs, of needed vaccines,
diagnostic tests, and other priority countermeasures. And the bill
helps ensure that our national strategic pharmaceutical stockpile is
adequate to meet the needs of America.
The October anthrax-laden letters underscored the importance of
coordination, the importance of communication. The conference agreement
puts in place structures to ensure improved
[[Page S4779]]
government coordination, as well as improved collaboration between
government and the private sector. The legislation helps us develop the
state-of-the-art communication infrastructure so we can more readily
and more rapidly identify and treat infectious disease outbreaks. It
also helps ensure that our children and other vulnerable populations
are better prepared.
This conference agreement will significantly improve our ability to
protect our water supply, our food supply, our Nation's agriculture,
and it will help better track and regulate the use of dangerous
pathogens within our borders.
The bill focuses on what happens at the local level, at the community
level. If you are suspicious, if an attack occurs, you pick up the
telephone, you call somebody, or go to a local facility. This bill
underscores the importance of support at the local level.
The legislation will provide significant new resources, $1.6 billion
in the year 2003 alone, to strengthen our State and local public health
systems. We have underinvested in our public health infrastructure in
the last 30 years in this country.
As the title of the bill makes clear, this legislation will not only
improve our ability to respond to bioterrorism but to other public
health risks, and emergencies as well, whether they be from other
intentional acts of terrorism, nuclear attacks, chemical accidents or
attacks, or from naturally occurring infectious disease outbreaks, the
so-called dual use of the investment that we put in public health
today.
I am proud to be part of this legislation. I believe that years from
now America will look back upon this bill as landmark legislation, a
landmark achievement, a turning point in our commitment to
strengthening our defenses, focusing on biological threats.
As has been mentioned by my colleagues, I am very pleased with the
reauthorization of what is called the Prescription Drug User Fee Act.
This important law helps make it possible for the Food and Drug
Administration to hire additional manpower and expertise to speed the
drug approval process so consumers can benefit more quickly in a safe
way from life-saving drugs.
I am also pleased this agreement includes the Frist-Kennedy Emergency
Access to Defibrillator Act, an act which has passed the Senate earlier
this year, a provision which will provide annual grants to deploy
lifesaving cardiac heart defibrillators in more public buildings.
My colleague, Senator Gregg, has already recognized so many people
who have participated in such an admirable way to this bill. There are
items that I, too, would like to have included in this particular bill
that are not in the final package, items that I think we must continue
to address in the Senate and in committee. I believe we need more
certainty if private industry truly is to become a partner in combating
bioterrorism. To harness the genius, to harness the resources of
private companies in these efforts, we should continue to find ways to
protect companies from frivolous lawsuits and provide pharmaceutical
research companies and others the certainty that they will not face
antitrust enforcement simply because they are collaborating with the
Government and their business partners to more rapidly and more
rationally develop vaccines and other countermeasures.
This is a solid bill. It combines sound policy and enhanced resources
to better prepare our Nation and to provide security to the American
people. Once again, I commend Senator Kennedy for his dedication and
leadership. In many ways, this legislation builds upon a foundation we
began about 3 years ago as we began, in a bipartisan way, to develop
this issue of bioterrorism. He and I agree that protecting the American
people from bioterrorist attacks and other public health threats and
emergencies does require a robust, a reinvigorated public health
system.
I also thank and commend the ranking member of the Senate HELP
Committee, Senator Gregg, as well as the other Senate Republican
conferees he has previously mentioned, Senator Enzi and Senator Tim
Hutchinson, for the tremendous work he is doing in the agricultural and
rural elements of the bill. Other Members, Senators Roberts, DeWine,
Collins, and Hatch, also were instrumental in drafting this important
legislation.
Finally, it is difficult to pass legislation of this magnitude
without the assistance and diligence of dedicated staff. Most of those
staff members have been recognized already. I do want to thank members
of my own staff, in particular Dean Rosen, Helen Rhee, Shana Christrup,
and Doug Campos-Outcalt, a fellow in my office. I would also like to
recognize the contributions of Vince Ventimiglia, Katy French, and
Steve Irizzary of Senator Gregg's staff; David Nexon, Paul Kim, David
Bowen, and David Dorsey of Senator Kennedy's staff; Raissa Geary of
Senator Enzi's staff; Kate Hull of Senator Hutchinson's staff; and Mike
Seyfert and Lisa Meyer of Senator Roberts' staff.
Finally, with this bill we will take away one of the most formidable
weapons in the terrorist arsenal, and that is our own vulnerability.
I yield the floor.
Mr. KENNEDY. Mr. President, I yield 7 minutes to the Senator from New
York.
The PRESIDING OFFICER. The Senator from New York is recognized for 7
minutes.
Mrs. CLINTON. I thank the chairman for yielding me that time. I, too,
wish to add my words of gratitude for the work that has been done on
this bipartisan, comprehensive bioterrorism legislation. Under the
leadership of Chairman Kennedy and Ranking Member Gregg, and Senator
Frist, as well as a number of others of our colleagues, we are about to
pass legislation that I think will make a significant difference in the
health, safety, and preparedness of our Nation. Americans know we
cannot wait for another bioterrorism incident such as the one we
suffered last fall with respect to the anthrax attacks before we take
action to protect ourselves.
This bill contains a number of critical provisions that will improve
national, State, and local preparedness. The authorization of a
national stockpile of vaccines, antibiotics, and other drugs necessary
in the case of an outbreak or other incident is absolutely essential.
Furthermore, the emphasis on public health is long overdue, as
Senator Frist so eloquently stated. This bill will invest over $1
billion in grants to our States to assure the adequate planning that is
necessary to improve State and local public health system preparedness.
I know all of us were surprised when we learned that many public
health offices were more in the early 20th century with respect to
their equipment and communications capability than in the early 21st
century. They didn't have fax machines or e-mail capabilities. One of
the problems we encountered with respect to our efforts to get ahead of
the anthrax outbreaks and attacks was, in fact, the inability to
communicate at different levels of government.
The underinvestment in our public health infrastructure has been
unacceptable. Now we are about to reverse it. This is long overdue and
to be applauded.
I also appreciate the bill authorizing $520 million to equip
hospitals to respond to bioterrorism.
After 9-11, when we had our hospitals on alert to try to take care of
what we at the time thought would be thousands of injured people--
unfortunately, it turned out to be thousands of deaths and relatively
few people who were injured--we found we were not prepared because we
could not perform many of the functions that were necessary, not only
to respond to the attacks but the aftermath.
For example, many of the first responders went, after their duties at
the Ground Zero site, to be decontaminated. There was no
decontamination system. Many ended up at our hospitals in New York and
were in very cramped and totally insufficient situations to try to
decontaminate them before they went back to Ground Zero.
That is just one example of what we determined was absolutely
unacceptable, given the threats we currently face. So we will be
providing training and other provisions to promote the development and
production of treatments and what is necessary for our hospitals to be
prepared.
I also applaud the inclusion of strong provisions to safeguard our
food supply
[[Page S4780]]
and to provide for the protection of our children. We are finally
coming into the recognition that we have not protected our food supply,
now that we are in a global marketplace, the way we need to. These
provisions that are included are ones that I and others have long
believed were absolutely essential to establishing a registration
system for food manufacturers, to give the FDA records
inspection authority to trace back investigations, to provide for prior
notice of imported food, to allow the cross-utilization of inspectors--
both from USDA and FDA--to provide grants for surveillance and
protection, and to improve the surveillance of diseases affecting both
animals and humans.
I am very pleased, too, that this bill contains provisions I
introduced in legislation, along with Senator Dodd and Congresswoman
Slaughter from New York, to address the special needs of children.
We know children have special vulnerabilities, and we also know
biological and chemical agents can have a particularly bad and
different effect on children because children are lower to the ground
where we have gases that are dense and inert. We have other challenges
in dealing with what happens to our children dealing with a
bioterrorism attack. We have therefore established a national advisory
commission on children and bioterrorism, and we will do much more to
try to provide guidance on how best to protect our children.
I also applaud the provision of $100 million to keep Plum Island, off
the coast of New York, at its current biosecurity level and to
modernize and improve the security of the facilities.
Also, I think it is essential we are adding to our security at water
systems and expanding the availability of potassium iodide for
communities near nuclear powerplants, such as Indian Point near where I
live.
While we have taken such strong steps related to bioterrorism and
children and food security and water security, I do have to express a
disappointment that we were unable to include the codification of the
pediatric rule that would require the testing of drugs that might be
prescribed for our children. Senators Dodd and DeWine and I have
introduced legislation to bring this about. Unfortunately, we were
unable to attain support to have it included. But we will be taking
steps, through a markup at the committee level and then with
legislation, to try to ensure that the drug manufacturers to whom we
have given access to an improved streamlined drug approval process--
which we all support--also will be assuring us that the drugs needed by
our children are safe and properly labeled.
This is a very good bill. There obviously are some features that
should be included to make us stronger in the future, but I applaud my
colleagues, and particularly those who shepherded it through the
conference, for making us, today, safer than we would have been
otherwise.
The PRESIDING OFFICER. Who yields time?
Mr. GREGG. Will the Chair advise us as to the present status?
The PRESIDING OFFICER. The Senator from New Hampshire has almost 11
minutes remaining, and the Senator from Massachusetts has almost 10
minutes remaining.
Mr. GREGG. I yield 5 minutes to the Senator from Texas.
The PRESIDING OFFICER. The Senator from Texas is recognized for 5
minutes.
Mrs. HUTCHISON. I thank Senator Gregg and Senator Kennedy for
pursuing this bill. I certainly support it. As part of the fight
against terrorism, we must dedicate the resources to the growing threat
of bioterrorism. This legislation enhances the capabilities of Federal,
State, and local governments to coordinate emergency preparedness
efforts, to stockpile vaccines and medical supplies, to modernize
biosecurity facilities, and try to ensure the safety of America's
health and food supply.
I worked with my colleague, Senator Pat Roberts, to address the
concerns about our food supply and vital agricultural economies. The
agricultural bioterrorism provisions in this legislation will authorize
the Department of Agriculture to strengthen its capacities to identify,
prepare for, and respond to the bioterrorist threats to our farms,
ranches, and food processing, packaging, and distribution facilities
and systems.
We have a clear priority to ensure the safety of our food and to
maintain public confidence. To do so we must identify and quickly
control the threat to our food supply, currently the world's safest,
most abundant, and affordable.
During the cold war, we knew the Soviet Union had bioweapons that
included bioagents aimed at agriculture. Following the gulf war, we
know our soldiers showed evidence of possible exposure to chemical and
biological weapons. From the terrorist attacks on Japan's subway system
with sarin gas to the recent anthrax attacks here in the United States,
the public is now acutely aware of bioterrorist threats.
This bill is critical, both for the results it will achieve and the
reassurance it will provide.
The Department of Agriculture will be expanded to enhance inspection
capability, implement new information technology, and develop methods
for rapid detection and identification of plants and animal disease.
The U.S. Department of Agriculture's Veterinarian Services will also
be authorized to establish cooperative agreements with State animal
health commissions and private veterinarian practitioners to enhance
their ability to respond to outbreaks of any animal disease.
This bill directs the Department of Agriculture to establish a long-
term program of research to enhance biosecurity of U.S. agriculture.
America's universities that have demonstrated expertise in animal and
plant disease research in coordination with State cooperative extension
programs will provide the resources and expertise that will prove
invaluable in the war on agricultural bioterrorism.
The front lines of this war on terrorism lie on our own shores, farms
and fields, and the States where food is produced. However our States
are vulnerable, they will meet the challenge, and they will help us in
this war on bioterrorism because they will be able to detect the first
evidence of an attack to protect our citizens, our economy, and our
food supply.
I urge my colleagues to support the bill before us today. I
appreciate the hard work that went into making it come to the floor and
making it the priority that it should be for our country.
I thank the Chair. I yield the floor.
MEDICARE PROVISIONS IN BIOTERRORISM
Mr. BAUCUS. Mr. President, some of the provisions in the bioterrorism
bill have not received much attention. These provisions affect
Medicare, Medicaid and the Children's Health Insurance Program, or
CHIP.
What we have done here is to give the HHS Secretary the ability to
waive certain requirements in the face of a bioterror event or other
public health emergency.
For example, the bill would give the Centers for Medicare and
Medicaid Services the ability to pay providers for services rendered in
good faith during an emergency, even if certain paperwork or other
regulations are not followed.
In short, the bill gives our federal health programs the flexibility
they need to operate in times of emergency, while ensuring
accountability if the waiver authority is ever used. The administration
asked Congress for these provisions, and Senator Grassley and I both
agreed that they are needed.
I also want to add that the Medicare and Medicaid provisions in this
legislation were hammered out together in a bipartisan and bicameral
fashion. Although Senator Grassley and I were not conferees, our staffs
worked extensively with the conference staffs to negotiate these
provisions.
In fact, all of the authorizing Committees, both sides of the aisle
and both House and Senate, worked together on these provisions.
Mr. GRASSLEY. Mr. President, allowing items within the jurisdiction
of the Finance Committee to be added in conference is not something I
do lightly. It is critical that we follow regular order, and that
committees of jurisdiction hold hearings and examine proposals before
the Senate acts. This is, however, an exceptional situation.
In light of the current threats to our nation, we must make these
changes to
[[Page S4781]]
make our Federal health care programs more flexible, and more
responsive to patients, in times of crisis. In my view, this is
important enough to make an exception to our general rule of asserting
our committee's jurisdiction. Also urgent are two provisions that
stabilize Medicare managed care plans, which many seniors have come to
rely on.
And as Senator Baucus mentioned, our staffs worked closely with the
conferees' staffs to make sure that we were comfortable with the
provisions that were included.
Mr. BAUCUS. The Senator is right. And briefly, in addition to the
waiver provisions that affect Medicare, Medicaid and CHIP, this
legislation includes a provision that will suspend the Medicare+Choice
``lock-in'' requirement for three years.
Current law requires Medicare beneficiaries to remain in their
managed care plan for the full year. HMOs and beneficiary advocacy
groups have both urged Congress to suspend this requirement as a way to
stabilize this program.
While I appreciate the argument that a plan and a beneficiary should
be required to make a full one-year commitment, I don't believe that
this is the time to implement the lock-in requirement. Plans are
pulling out of the Medicare program every year. Thousands of
beneficiaries have lost the plans in their area. Because of the current
instability in the program, it is my view that Congress should wait
until the program is more stable before we implement the lock-in.
Mr. GRASSLEY. I agree, and believe that we have got to take other
steps to ensure that seniors understand the choices they have even
before the lock-in is in place. I have always believed that informed
health care choice is the key to a successful Medicare+Choice system.
That is why I fought hard in the 1997 Balanced Budget Act for the
National Medicare Education Project, which required CMS--then called
HCFA--to start a 1-800 number and to send out detailed plan comparison
materials to every senior every year. I think this program has been a
success, and I intend to push for additional funding for it this year.
But Medicare education needs even more improvement, especially before
seniors get locked-in to a specific plan for a whole year. So I think
it is important that this bill delays the lock-in requirement. I would
also like to point out that our doing so today is in sync with recent
recommendations from the Advisory Panel on Medicare Education.
Finally, the bill gives health plans an additional three months to
assess their costs before making a decision to participate in the
Medicare program. Because of exceptional circumstances with respect to
timing, we needed to make this change to the so-called ``ACR filing
date'' now--prior to the time the Finance Committee acts on Medicare
legislation. As I have mentioned, I am not normally willing to make
exceptions to Finance Committee jurisdiction, but the circumstances
here justify such an exception in this case.
Mr. BAUCUS. Let me summarize by saying that I agree with my good
friend Senator Grassley, that every so often there are circumstances
that warrant an exception to our jurisdictional concerns, and this is
one of them.
Mr. GRASSLEY. I believe that bodes well for our future work together
on Medicare legislation in the Finance Committee.
Mr. BAUCUS. Yes, indeed. I look forward to working together in a
bipartisan and bicameral fashion on all the other Medicare, Medicaid,
and health issues that the Congress will be working on this summer and
fall.
Mr. AKAKA. Mr. President, I rise today to give strong support to H.R.
3448, the Public Health Security and Bioterrorism Preparedness and
Response Act. The Nation is looking to Congress to provide the building
blocks to prepare for and respond to bioterrorism. H.R. 3448 takes
several good steps to coordinate and strengthen Federal programs and
help states and communities prepare for bioterrorism and other public
health crises. As an original cosponsor of the Senate companion bill, I
am proud to support the final product. The work that the bill managers
and their staff have done in preparing this important legislation is to
be commended.
H.R. 3448 provides $1.1 billion in funding for grants to state and
local governments to prepare response plans, buy equipment, and train
health care workers for bioterrorism and other public health
emergencies, and an additional $520 million for community hospitals.
The Act authorizes funding and establishes safety procedures for
scientists to use pathogens for vaccine and disease research. H.R. 3448
builds up many of the Nation's resources that have been weakened from
years of neglect and also addresses several new concerns.
Early detection of a biological threat is critical in minimizing the
number of people exposed to an agent and the extent that the agent or
disease will spread. New tools capable of detecting small quantities of
infectious agents in food, water, air and other vectors are needed. For
this reason, I introduced S. 1560, the Biological Agent-Environmental
Detection Act of 2001. I am pleased to see provisions of my bill
included in H.R. 3448, especially the authorization of funding to
improve testing, verification, and calibrating of new detection and
surveillance techniques and tools. Scientists and engineers in our
universities and national labs are conducting exciting research on air
and water monitoring and developing satellite-based remote sensing
technologies to identify weather patterns that contribute to the spread
of infectious disease and biological or chemical attacks. I am
convinced that these men and women can develop robust, effective, and
accurate detection methods.
Creating a critical line of defense against bioterrorism must involve
health care professionals. Through hearings and discussions with health
care providers and bioterrorism experts, it is clear that our doctors
and nurses are not trained to recognize or respond to bioterrorism. For
this reason, Senator Rockefeller and I introduced S. 1561,
Strengthening Bioterrorism Preparedness Through Expanded National
Disaster Medical System Training Programs. I am pleased that H.R. 3448
includes our proposal to use the existing emergency communication
infrastructure, disaster training program, and community partnerships
within the nation's 163 Veterans Affairs hospitals to train VA and
Department of Defense staff and local health care providers in
recognizing and treating victims of biological weapons.
This is but one way in which the Department of Veterans Affairs
serves the nation in bioterrorism preparedness and public health. The
$133 million dedicated to VA will expand these efforts and is well
deserved.
Congress has not forgotten the role our local and community hospitals
will play in such a crisis. We also are working to give our medical
professionals, public health officials, and emergency managers the
earliest possible warning of pending outbreaks. The problems we face
with bioterrorism are not new, nor are they related solely to
bioterrorism. Our hospitals lack the capacity to handle even a handful
of extra patients during flu season, let alone hundreds of people
seeking critical care during an intentional epidemic. Passing the
Public Health Security and Bioterrorism Preparedness and Response Act
is only the first step in making America safer. Now we can provide the
hard working men and women in public service, academia, and private
industry with the resources needed to continue protecting this country
from bioterrorism.
Mr. WELLSTONE. Mr. President, I rise today to support the Public
Health Security and Bioterrorism Response Act. This act represents a
critically important turning point in the readiness of our public
health system to respond to the challenge of bioterrorism. In many
places in our Nation the public health infrastructure has been
underfunded and understaffed. The anthrax attack has demonstrated that
our system can be overwhelmed by a bioterrorist attack. This bill
provides essential assistance to our network of local and state health
departments, public health laboratories, hospitals and health care
facilities so that they can protect all of us in the event of further
bioterrorist attack, or of other infectious disease outbreaks.
We in Minnesota have long been aware of the dangers of bioterrorism
thanks to the efforts of Mike Osterholm, head of the Center for
Infectious Disease Research and Policy
[[Page S4782]]
at the University of Minnesota. I am very glad that this bill is
providing for the kind of bioterrorism preparedness our nation needs.
This bill provides block grants to states to improve public health
departments and to get the equipment they need, and to help local
governments safeguard their communities from these threats. The bill
also provides grants to hospitals and other health care facilities to
improve their abilities to respond quickly and effectively to a
bioterrorist attack. I am pleased that the authorization for our
hospitals has been increased from $370 to $520 million. I am also glad
this bill emphasizes getting funds to the local level. That is very
important. In fact, I would have even gone further in setting aside
funds specifically for localities. I am also glad that the antitrust
exemption in the Senate bill has been dropped from the conference
report.
As Chair of the Subcommittee on Employment, Safety and Training, I am
particularly glad that this bill recognizes the threat of bioterrorism
in the workplace. Virtually all of the anthrax attacks involved places
where people work, including media offices, the U.S. Postal Service and
here in the Congress. I am especially happy that this bill includes
language which I had suggested to direct the National Institute of
Occupational Safety and Health to expand research on the health and
safety of workers who are at risk for biological threats or attacks in
the work place.
Finally, I am particularly pleased that my provisions regarding
mental health were included in this important bill. We know from the
outstanding hearings on mental health and terrorism, chaired by Senator
Kennedy in the HELP Committee, that the preparedness and response
activities for the mental health consequences of bioterrorism are as
important as all other public health initiatives this Congress can
support. Recent press reports citing research on the psychological
consequences of exposure to terrorist attacks, as well as the necessity
of dealing with ongoing threats, have demonstrated clearly that mental
health is an integral part of our ability to respond appropriately to
bioterrorism attacks.
I am particularly pleased that Public Health Security and
Bioterrorism Response Act established mental health response
preparedness as one of the primary goals in our national initiative The
mental health provisions in the bill will support federal, state, and
local efforts to enhance the preparedness of public health institutions
to coordinate mental health services. The bill also establishes as one
of the primary responsibilities of the federal Working Group on
Bioterrorism and Other Public Health Emergencies to make
recommendations regarding the preparedness of public health
institutions and emergency service personnel to detect, diagnose, and
respond appropriately with regard to mental health needs in the
aftermath of a biological threat or attack.
A special focus on children's mental health was established through a
required National Advisory Committee on Children and Terrorism, whose
responsibilities include making recommendations regarding the
preparedness of the mental health care system to respond to
bioterrorism as it relates to children. Similarly, a required Emergency
Public Information and Communications Advisory Committee will include
experts on behavioral psychology among its members and will make
recommendations on appropriate ways to communicate public health
information regarding bioterrorism. The bill also includes mental
health training as one of the designated funding activities,
specifically to enhance the training of health care professionals to
recognize and treat the mental health consequences of bioterrorism or
other public health emergencies. And finally, the bill authorizes
funding for mental health counseling programs to be coordinated by the
Department of Veterans Affairs to develop and maintain various
strategies for providing mental health counseling and assistance to
local and community emergency response providers, veterans, active duty
personnel, and individuals seeking care at Department VA medical
centers following a bioterrorist attack or other public health
emergency. The VA program also includes funding for training and
certification programs.
We know one for thing for sure. It is a mistake to believe that
bioterrorism events cannot have lasting impact on the mental health of
the individuals who experience them. Let us not repeat the mistakes
that were made in the aftermath of the Vietnam war, when the trauma
experienced by veterans and their families was ignored or trivialized
until well after the optimal time for treatment was past. We have
learned from the outstanding research funded by the National Institute
of Mental Health and the Department of Veterans Affairs regarding the
severity of the trauma-related disorders and the effective ways in
which it can be treated. We must ensure that all federal, state, and
local public health efforts to respond to and prepare for bioterrorist
attacks take advantage of this knowledge.
I do not believe that mental health problems are a widespread or
inevitable consequence of bioterrorist attacks. But as we heard from
the experts at the HELP Committee hearing, we should not underestimate
the severe impact that these events have on people's sense of identity
and safety, and how the multiple losses and horrific experiences they
go through has the potential to affect them for a long while. There
have been many reports in the media of the heightened sense of anxiety
and vulnerability throughout our country. These feelings are normal and
I have confidence that most Americans will be able to deal with these
crises. But I also firmly believe that the Federal, State, and local
governments can play a major role in helping people to understand what
has happened to them, and establish programs for mental health services
for those who will need it. We in Congress are doing our part by the
inclusion of these mental health initiatives within this bill.
In closing, this bill represents an essential step forward in
safeguarding both the physical and mental health of our nation in the
event of further bioterrorist attack.
Mr. HARKIN. Mr. President, last year, the weakness of our Nation's
ability to respond to a bioterrorist attack was exposed. To properly
prepare for the future, we must begin to think of our Nation's public
health system as the front lines in our battle against terrorism.
Unfortunately, our troops were inexperienced, our radar was out of
date, and we were short on ammunition. Right now we don't have enough
vaccines to protect every American. Public health officials were
without the tools and training they need to detect an outbreak and
rapidly respond.
Prudence demanded action. That is why Senator Specter, Senator Byrd
and I crafted and passed a $3.6 billion bioterrorism initiative to
reverse this alarming trend. As a result of this effort, our Nation's
defenses against bioterrorism has improved since September 11 and the
anthrax attacks of last October, but much more still needs to be done.
As chairman of the Labor-Health and Human Services Appropriations
Subcommittee, I held several hearings with a broad variety of people,
ranging from leaders of the Federal Government to first responders to
our local public health workers.
As a conferee for the bioterrorism bill, I'm proud of the bipartisan
work we have been able to achieve on this plan to boost our Nation's
bioterrorism prevention and preparedness. The initiatives included in
this conference report will build on the Harkin-Specter bioterrorism
plan that President Bush signed into law in January, and will
aggressively ramp-up efforts to keep America the safest country in the
world.
I am especially supportive of the provisions in this conference
report that I proposed in a seven-point plan I released following the
anthrax attack last fall.
Specifically, the measure will:
Increase training for public health and medical officials: State and
local officials, as well as doctors, nurses and other health
professionals will be trained in diagnosis and treatment of
bioterrorism exposure, as well as rapid communication to colleagues on
case exposure and the identification of trends.
Bolster vaccine stockpiles: Currently our stockpile of small pox
vaccines could only vaccinate about 25 percent of Americans, and our
anthrax vaccine
[[Page S4783]]
stockpiles are also vastly inadequate. This legislation will increase
funding to increase supplies and improve systems of transport to make
sure that the appropriate pharmaceuticals can quickly get where they
are needed.
Ensure that there are round-the-clock disease investigators in every
state: A number of states have no full-time experts charged with
identifying and dealing with infectious diseases. Federal support can
be used to ensure that every single state has at least one professional
in charge of detecting disease and notifying proper authorities.
Increase hospital surge capacity: The conference report will increase
funding for planning and staffing to meet possible high-volume cases of
infectious disease exposure. Funds would be administered through an
innovative grant program that provides support for wide-ranging
initiatives that will improve state and local hospital preparedness for
response to bioterrorism and other public health threats.
Improve surveillance and information sharing capacity at all levels
of government: The legislation will ensure that all local health
departments have access to the Health Alert Network. Currently, health
departments in some states don's have fax machines and Internet access.
Funding will expand the Health Alert Network so that health
professionals are able to quickly key in on outbreaks and share their
information around the country and the world.
Expand food safety inspections: Through this bill, every domestic and
importer of processed foods must register with the Food and Drug
Administration, FDA, farms, restaurants and nonprofit food
establishments like soup kitchens are exempted. Also the FDA's
authority is expanded to allow them to stop any food or product that
may present a public health risk and allows the agency to ban importers
who repeatedly violate food safety regulations. Lastly, the FDA is
given authority to inspect food processing establishment's records
related to food safety. Currently the FDA can only get such records
through court action.
Create and maintain a comprehensive database of the locations of
biohazardous pathogens: Finally, this legislation will for the first
time require that the U.S. Department of Health and Human Services and
Agriculture closely regulate and register the possession, use and
transfer of the most dangerous pathogens like anthrax and small pox.
Security standards for these facilities will be established, and all
people with access to the agents will be screened. Facilities with
these pathogens will be inspected, and violation of these rules will be
punishable by strict criminal and civil penalties.
Again I am very pleased to support this conference report and I look
forward to continuing to work in a strong bipartisan process with the
President, Secretary Thompson and the rest of the administration to
make sure adequate funding is provided for these critically important
initatives.
Mr. HUTCHINSON. Mr. President, the Senate is going to pass landmark
legislation today bolstering our Nation's efforts to prepare against
future bioterrorist threats and attacks. As a member of the joint
House-Senate bioterrorism conference committee, I am pleased to support
this conference report.
Eight months ago, five U.S. citizens died due to anthrax, buildings
were shut down, and thousands of Americans were tested for possible
exposure. Our country learned first hand about the need for improved
knowledge about biological weapons and agents--how to detect them, what
to do in the case of exposure, and the need for accelerated research
and development of countermeasures to defend against such agents.
The Public Health Security and Bioterrorism Preparedness and Response
Act provides for the development of vaccines and drugs to defend
against biological agents or toxins, improvement of public health
emergency response efforts, tightening of requirements for individuals
who use and possess biological agents or toxins, enhancement of
protections for our food supply and agricultural research facilities,
and the development of emergency response plans and security upgrades
for our Nation's water systems.
I would like to particularly highlight provisions in the conference
report to speed approval of vaccines and drugs developed as
countermeasures against biological weapons, improve security at
facilities where such countermeasures are researched and developed, and
strengthen federal penalties for acts of sabotage against such
facilities.
These provisions I introduced as part of freestanding legislation
last November, S. 1635, along with Senators Gregg and Frist. I believe
that these provisions are at the heart of our preparedness for future
bioterrorist threats and attacks.
I am thankful to my fellow Senate and House conferees for working
with me to include a proposal I offered to provide grants for
proficiency testing of laboratory personnel in identifying biological
agents and toxins. Laboratory personnel will be on the front lines of
our detection efforts, and we must make sure they can identify
biological toxins and agents.
All States, including Arkansas, will benefit from grants to improve
planning and State preparedness efforts, enhance laboratory capacity
and educate and train health care personnel. I am also pleased with the
inclusion of $5 million in grants for small community water systems in
order to conduct vulnerability assessments, prepare emergency response
plans, and make security upgrades.
In summary, this is comprehensive legislation and it is needed
legislation. The Public Health Security and Bioterrorism Preparedness
and Response Act lays the foundation for significant changes in
America's infrastructure, training, and response programs to protect
our Nation's citizens against deadly weapons, particularly biological
and chemical agents.
Mr. JEFFORDS. Mr. President, today we will have the opportunity to
act positively on one of the most important pieces of legislation that
we will consider in this Congress--the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. I am pleased that
we are able to vote today on this most vital piece of legislation. Many
of our colleagues have worked very hard on this legislation but would
like to take this opportunity at the outset of these comments to
acknowledge the work of Senator Kennedy, and Senator Frist for
originally introducing this bill in the Senate, as well as Congressman
Tauzin and Congressman Dingell for their work in the House.
From the events on September 11, and the anthrax incidents here in
our Capitol and around the country, we know first hand that terrorist
attacks on America continue to pose a real threat. We are not immune to
the cowardly attempts by well-armed and well-financed groups who intend
harm upon us, and we must continue to stand strong against those that
resent our nation's unyielding commitment to preserve freedom
throughout the world.
Today, Congress is taking a step in the right direction. The Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
solidifies the emergency measures taken last fall by Congress to
safeguard the health of all Americans. The Act greatly enhances our
ability to prevent and detect bioterrorist threats, and it gives us the
resources we need in order to effectively care for our citizens in the
event that another biological attack takes place on American soil.
The act is a comprehensive, interdepartmental effort to ensure the
safety of American families. This legislation will ensure proper
communication across Federal agencies so that all of our available
resources are put to their best use. As the cornerstone of our
emergency response to public health threats, hospitals will be provided
ample resources in order to ensure their preparedness in the event of a
biological attack. In addition, we have greatly enhanced our ability to
track labs and individuals who possess materials that could be used in
bioweapons aimed at people or the food we consume, and there are strong
measures taken to further protect the food supply throughout America.
A primary focus of our efforts is to ensure a National Pharmaceutical
Stockpile, and to increase production of vaccines for some of the most
deadly diseases, including smallpox. There are also provisions for more
timely FDA review of generic drugs, and it reauthorizes the
Prescription Drug User
[[Page S4784]]
Fee Act, PDUFA, an important measure to ensure that newly developed
drugs are made available to those who need them most in a safe and
timely fashion.
I am also pleased that this bill includes language requiring drinking
water systems across the country to assess their vulnerability to
terrorist attack and to develop emergency response plans to prepare for
and respond to such attacks. We all hope there is no need for
implementation of these plans, but information leads to preparation,
and I am pleased to have a bill today that recognizes the crucial
importance of assessing and addressing potential vulnerabilities.
As chairman of the Committee on Environment and Public Works, I have
worried about the lack of information within the Federal agencies about
the security of our Nation's critical infrastructure and facilities.
For instance, I am aware of one provision in the Clean Air Act which
requires the Department of Justice to assess the vulnerabilities of
chemical plants. This provision was enacted years before the tragic
events of September 11th, but the assessment is not yet complete. And
recently, in the wake of criticism that our government should have been
more prepared for terrorist attacks, I read a chilling statement from a
government official: ``People are saying we didn't connect the dots.
It's awfully hard to connect the dots if people don't give you the
dots.''
I do not doubt that industry, communities, local and State
governments and emergency responders are taking security measures
seriously. But important provisions in this bill will enable our
government to ``connect the dots,'' that is, to understand the safety
of our Nation's water supply. The substantial funding in this bill will
provide enhanced resources for completion of vulnerability assessments
quickly, and in a thorough manner. And by requiring that these
assessments be provided to the Environmental Protection Agency, we will
have the ability to evaluate the security needs of our drinking water
systems and to measure our national preparedness for potential threats
against our water supply.
In addition, we have addressed the concern that some information in
these assessments may be sensitive in nature. Although we recognize
that it is most often community knowledge and involvement that is most
effective in addressing a community's needs, we also recognize that
information in the wrong hands can endanger a community. This bill
balances these competing concerns by exempting the content of the
assessments from the Freedom of Information Act, by requiring
implementation of protocols to secure and limit access to the documents
at the EPA, and by imposition of criminal penalties upon persons
designated by the EPA Administrator to have access to the documents in
EPA's possession who knowingly or recklessly disclose those documents.
It is important to note, however, that there is not a restriction on
EPA's discussing the content of the assessments with persons who may
benefit from information about the security of our nation's water
supply, such as state and local officials, nor is there restriction
intended by this bill upon a water system's voluntarily sharing
information with other systems, emergency responders or communities.
Our attempt to provide a safeguard against broad disclosure of
sensitive information does not lead us to conclude that our citizens
should not have the information they need to protect and inform
themselves.
Finally, I had hoped that this bill would encompass wastewater
systems in addition to drinking water systems. I intend to pursue
comparable legislation for wastewater systems in this legislative
session.
This legislation reflects a remarkable effort that drew from the
jurisidictions of several Senate and House Committees including the
Health, Education, Labor and Pensions, the Energy and Commerce,
Finance, Ways and Means, Agriculture, Judiciary and my own Environment
and Public Works. The many Members from these Committees and the
conferees are to be commended for their contributions.
Once again I want to acknowledge the yeoman's work done by our staff.
In particular I want to recognize HELP Committee staff including, David
Nexon, Paul Kim, David Bowen and David Dorsey from Chairman Kennedy's
office; Vince Ventimiglia, Steve Irizarry and Katy French of Ranking
Member, Senator Gregg's office; and the staff of Senator Frist,
including Dean Rosen, Helen Rhee and Shanna Christrup, and Doug Campos-
Outcalt. Credit also goes to Debra Barrett, Raissa Geary, Adam Gluck,
Kate Hull and Rhonda Richards. Finally, I want to acknowledge my own
staff, Sean Donohue, Eric Silva, Allison Taylor and Jo-Ellen Darcy who
worked diligently to ensure that appropriate public health safeguards
were part of this measure, including environmental provisions that will
help provide for the safety of our public water systems.
Mrs. FEINSTEIN. Mr. President. I rise in strong support of passage of
the conference report for H.R. 3448, the Public Health and Bioterrorism
Response Act.
This legislation will make our Nation better prepared for
bioterrorist threats and other public health emergencies.
That is why I am pleased that this bill includes funding to bolster
the National Pharmaceutical Stockpile, including enough smallpox
vaccine to protect every American.
We must ensure that there are sufficient vaccines, drugs, and medical
supplies available to protect Americans against any potential
biological attack. I believe this bill moves us one step closer to
protecting every American from this threat.
It is also crucial that we assist our States and local hospitals and
health departments in beefing up their systems, including training
personnel and first-responders on how to respond to a bioterrorism
attacks.
This legislation includes $1.6 billion for fiscal year 2003 to
address these needs.
I am particularly pleased that the conference report includes a
provision which I sponsored along with Senator Judd Gregg, R-NH,
establishing strict new controls for laboratories that handle anthrax,
smallpox, and more than 30 other deadly pathogens.
These provisions are the product of extensive negotiations with a
number of other Senators including, Senator Frist, Kennedy, Harkin, and
Durbin, as well as House Conferees, and the administration.
The threat of biological attacks became front page news last fall,
when deadly anthrax attacks killed five people, infected 23 people, 11
with inhalation anthrax and 12 with cutaneous anthrax, and shut down a
Senate office building for 3 months.
The FBI has poured extraordinary resources into apprehending the
perpetrator. Over the past 5 months, FBI agents have interviewed more
than 5,000 people and offered a $2.5 million reward. Unfortunately, it
has been unable to locate a single witness, fingerprint or a match to
the handwriting found on the envelopes.
We still do not know when or if the perpetrator will be found.
It became clear during the investigation of the anthrax attacks that
the regulations governing these dangerous substances were too lax.
Our government did not keep track of who possesses these materials.
No special registration was required to possess these agents.
Nor were background checks conducted on the laboratory personnel who
handled or had access to these agents.
Under these security conditions, a rogue employee or outside
terrorist group could easily gain access to some of the most dangerous
pathogens on Earth.
To close these loopholes, I introduced the Deadly Biological Agent
Control Act last fall with Senator Jon Kyl, R-AZ, and a similar
provision was approved as part of the fiscal year 2002 Department of
Defense Appropriations bill.
I am pleased that key portions of this legislation were included in
the final comprehensive bioterrorism package.
The conference report has the following key provisions: All labs that
possess these dangerous agents would have to get registered with the
Department of Health and Human Services or the Department of
Agriculture, for animal pathogens.
The registration process would include rigorous background screening
by the Department of Justice of any laboratory employees intending to
handle the agents.
[[Page S4785]]
Anyone who possesses these agents without obtaining a registration
will be subject to 5 years in Federal prison.
The legislation also creates, for the first time, a national database
of dangerous pathogens, so that the characterization, location and use
of these agents can be tracked.
Tighter controls of these agents are critical because they can be
converted into weapons of mass destruction.
In addition, to make sure that this list of dangerous agents is kept
up-to-date, it must be reviewed a minimum of every two years.
We need these strong measures because in the wrong hands, these
biological agents can be converted into weapons of mass destruction.
According to the calculation of some experts, biological weapons are
pound for pound potentially more lethal even than thermonuclear
weapons.
For example, the World Health Organization estimates that 50
kilograms of the virus that causes the plague, aerosolized over an
urban city of 500,000, would incapacitate one fifth of the population
and kill 55,000.
A 1993 report by the U.S. Congressional Office of Technology
Assessment estimated that between 130,000 and 3 million deaths could
follow the aerosolized release of 100 kilograms of anthrax spores
upwind of the Washington D.C. area, lethally matching or exceeding that
of a hydrogen bomb.
In sum, I believe it is critical that these laboratory security
provisions were incorporated into this bioterrorism bill.
Any comprehensive bioterrorism preparedness package would be
incomplete without addressing laboratory security here in the United
States.
These controls are reasonable and necessary, given the extraordinary
threat posed by biological and chemical weapons.
Ms. LANDRIEU. Mr. President, I would like to take this opportunity to
thank the members of the bioterrorism conference committee who have
worked tirelessly over the last few months to craft this comprehensive
response to our Nation's needs in bioterrorism. I rise today to make
one point for the record in regards to this legislation. Following the
September 11th attacks, Secretary Thompson, under the authority granted
to him by Section 319 of the Public health Services Act, provided
resources to rebuild and replenish our Nation's emergency health care
providers who were directly affected by this terrible disaster. In sum,
the Secretary awarded over $35 million in grants to hospitals,
ambulance companies, and other first responders who responded or stood
ready to respond to the health needs of those injured in the attacks on
the World Trade Center and the Pentagon. These awards were made in
recognition of the contributions that these providers made, regardless
of their ownership. I commend the Secretary for this action.
Disaster strikes without respect to hospital ownership. By exercising
his discretion to award grants to all hospitals who responded, both
private and public, Secretary Thompson recognized this important point
and more importantly, fulfilled the statutory purpose of Section 319,
providing continued access to necessary acute care, Nationally, there
are 5,194 hospitals, and of those approximately 1,200 are for-profits.
That is one out of every four hospitals. In many markets, for-profit
hospitals--not the tax-exempts--serve as the safety net or sole-
community providers and that makes them 100 percent of the market in
their communities. In my home State, approximately \1/3\ of the
hospitals are for-profit. If a bio-terrorist attack were to ever happen
in Louisiana, I can guarantee you that our investor-owned hospitals
will play a critical role in the response. Those who are affected by a
bio-terrorist attack will go to their local hospital for help; they
will not check first to see how the hospital is being run.
I am pleased that the conferees added language in this bill to
strengthen the Secretary's authority to act as he did in this regard
following September 11th. I hope that this administration and the
administrations that follow will continue to recognize the important
role that all of our hospitals play in the delivery of emergency health
care.
Mr. CRAIG. Mr. President, I understand we have one more speaker on
our side who is on the way to the floor. I guess there are about 5
minutes remaining.
Mr. KENNEDY. Mr. President, I yield myself 5 minutes.
I wish to comment on the efforts of our friend and colleague from New
York, Senator Clinton, on the pediatric drug labeling rule.
As Senator Clinton pointed out, this issue is of great importance to
herself, Senator Dodd, and Senator DeWine. Senator Dodd, who is
chairman of the Children's Caucus, Senator DeWine, and Senator Clinton
have worked very effectively on the question of pediatric drugs,
particularly on the recent reauthorization of pediatric drug
exclusivity.
I had hoped we would be able to secure the Pediatric Rule in this
conference, but we were unable to do so. The research which would flow
from this important rule is critical to children. That is why the FDA
and the Administration took another look at their proposal to suspend
the Rule. It was very wise of them to review that decision and to keep
the Rule in place. But with the litigation ongoing, it is still being
challenged. This is something we in the Senate will give focus and
attention to in the very near future.
I have spoken with Senator Dodd, Senator DeWine, and Senator Clinton.
They know that we will address the Pediatric Rule in our committee in
the near future. We will talk to our colleagues about the timing. But
we will try to address it in the near future. We thank them for their
continued interest.
So my colleagues understand what is at stake, let me repeat: without
the Rule, there will be less research conducted on the impact of many
drugs on children, and some products will not be studied at all.
Again, I give my colleagues the assurance that we will pursue this
issue in the coming months. We can't afford to compromise children's
health.
Mr. President, during consideration of the bioterrorism legislation,
there were a number of items which our colleagues raised which were
included, a great majority of which were strengthened and which we were
able to include in the conference report.
I talked with Senator Carnahan about the importance of developing a
Web site on bioterrorism so that accurate and good information would be
available and accessible to people across the country. This has been
included. It will provide important, accurate information to the public
as a result of Senator Carnahan's legislation. We are certain this will
be helpful to families, not only in her State but across the country.
Senator Tim Johnson had some important proposals on agricultural
bioterrorism. Those provisions were added to strengthen the food safety
aspects of our legislation. We have included those, not least of which
calls for the President's Council on Food Safety to develop in a timely
but collaborative manner a national strategy for food security.
Senator Wellstone had major proposals on enhancing the FDA's ability
to protect the public health. We included many of those, particularly
those strengthening oversight of drug safety and drug promotions.
Senator Daschle was enormously interested in how we were going to
protect America's farm families. We have many additional protections
included in the legislation dealing with agroterrorism, such as mad cow
disease, which are very important. His work with Senator Roberts led to
a broad increase in resources and requirements for USDA.
How much time remains on our side?
The PRESIDING OFFICER (Mr. Wyden). The Senator from Massachusetts has
6 minutes 10 seconds. The Senator from New Hampshire has 6 minutes 50
seconds.
Mr. CRAIG. Mr. President, I suggest the absence of a quorum, and I
ask unanimous consent that the time be equally charged.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. KENNEDY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. Mr. President, for the information of the membership, we
[[Page S4786]]
understand Senator Collins will be coming in a few moments. After she
speaks, we intend to yield back the remaining time and move to a vote.
I anticipate we will have a vote on the conference report in probably
about 10 minutes. We will ask for the yeas and nays. So Members should
be alerted that we will proceed in that manner.
The PRESIDING OFFICER. The Senator from New Hampshire.
Mr. GREGG. Mr. President, in a moment, I will yield to Senator
Collins. But let me, again, thank the chairman for the expert and
professional way in which he handled this bill and moved it through the
process. It is not the beginning; it is not the end; it is the middle
of the process. But as a result of this bill, we will have put in place
the mechanisms to produce the vaccines we need as a nation in order to
protect ourselves from some of the most virulent biological agents with
which we might be attacked--a very important step.
As a result of this bill, we will begin the process of significantly
upgrading all the public health capabilities across this Nation,
whether it is in large States, small States, large cities, small
cities. That is very critical because, as we learned so well in the
instance of 9-11, the public health capability of dealing with a crisis
is one of the core elements of the first responder, the first line of
defense when it comes to a situation resulting from someone attacking
our Nation, especially with a biological or chemical agent.
So these two basic streams of effort, which are the core of this
bill--the bill has a lot more in it, but that is the core of this
bill--are going to make, I believe, a dramatic and significant
difference in our capabilities as a nation to handle the threat which
we, regrettably, confront now of someone using a biological or chemical
agent against us as a nation.
Mr. President, I yield up to 5 minutes, if she wishes it, if I have
it, to the Senator from Maine.
The PRESIDING OFFICER. The Senator from Maine is recognized for 4
minutes.
Ms. COLLINS. Mr. President, first, I begin by thanking Senator
Kennedy, Senator Judd Gregg, Senator Bill Frist, and all of those who
have worked so hard to bring this important legislation to the floor.
I am convinced that the bioterrorism bill to which we are about to
give final approval will make a real difference in our Nation's ability
to detect and, in the unfortunate event, respond to a bioterrorism
attack.
I am particularly pleased that the legislation includes food safety
provisions which I have advocated for some time.
In 1998, in my capacity as chairman of the Senate Permanent
Subcommittee on Investigations, I conducted a 16-month investigation
into the safety of imported food. What we found was truly frightening.
We discovered that the FDA inspects fewer than 1 percent of all
shipments of imported fruits and vegetables. And we discovered that the
safety net for ensuring that imported food was, indeed, wholesome and
safe was deeply flawed.
We found that an unscrupulous shipper could very easily ship tainted
food from one port to another without detection. If the system was that
vulnerable to an unethical shipper, think what a determined terrorist
could do.
So I am convinced the provisions included in this bill will make a
real difference in helping to ensure the safety of our food supply.
I note that the Secretary of Health and Human Services, Tommy
Thompson, recently testified before the HELP Committee that one of his
greatest concerns was the vulnerability of our food supply.
I believe the provisions that are included in this bill will help to
ensure that our food supply is safe from a terrorist attack.
We have a long way to go in the war against terrorism, but this major
bioterrorism legislation is an important step in securing the United
States of America.
Again, I commend the two leaders of our committee and all of those
who have worked so hard to bring us to agreement on this important
legislation.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KENNEDY. Mr. President, finally, again, I thank my colleague,
Senator Gregg, and Senator Frist, Senator Collins, and all of our
Members for their cooperation and their help.
I urge our colleagues to vote in favor of the conference report.
The PRESIDING OFFICER. The Senator from New Hampshire.
Mr. GREGG. Mr. President, have the yeas and nays been ordered?
The PRESIDING OFFICER. They have not.
Mr. KENNEDY. I yield the remainder of our time.
Mr. GREGG. Mr. President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There appears to be.
All time is yielded back.
The question is on agreeing to the conference report. The clerk will
call the roll.
The assistant legislative clerk called the roll.
Mr. REID. I announce that the Senator from Hawaii (Mr. Inouye) is
necessarily absent.
Mr. NICKLES. I announce that the Senator from North Carolina (Mr.
Helms) is necessarily absent.
The PRESIDING OFFICER. Are there any other Senators in the Chamber
desiring to vote?
The result was announced--yeas 98, nays 0, as follows:
[Rollcall Vote No. 124 Leg.]
YEAS--98
Akaka
Allard
Allen
Baucus
Bayh
Bennett
Biden
Bingaman
Bond
Boxer
Breaux
Brownback
Bunning
Burns
Byrd
Campbell
Cantwell
Carnahan
Carper
Chafee
Cleland
Clinton
Cochran
Collins
Conrad
Corzine
Craig
Crapo
Daschle
Dayton
DeWine
Dodd
Domenici
Dorgan
Durbin
Edwards
Ensign
Enzi
Feingold
Feinstein
Fitzgerald
Frist
Graham
Gramm
Grassley
Gregg
Hagel
Harkin
Hatch
Hollings
Hutchinson
Hutchison
Inhofe
Jeffords
Johnson
Kennedy
Kerry
Kohl
Kyl
Landrieu
Leahy
Levin
Lieberman
Lincoln
Lott
Lugar
McCain
McConnell
Mikulski
Miller
Murkowski
Murray
Nelson (FL)
Nelson (NE)
Nickles
Reed
Reid
Roberts
Rockefeller
Santorum
Sarbanes
Schumer
Sessions
Shelby
Smith (NH)
Smith (OR)
Snowe
Specter
Stabenow
Stevens
Thomas
Thompson
Thurmond
Torricelli
Voinovich
Warner
Wellstone
Wyden
NOT VOTING--2
Helms
Inouye
The conference report was agreed to.
Mr. REID. I move to reconsider the vote.
Mr. KENNEDY. I move to lay that motion on the table.
The motion to lay on the table was agreed to.
Mr. REID. Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. REID. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________