[Congressional Record Volume 148, Number 67 (Wednesday, May 22, 2002)]
[House]
[Pages H2844-H2860]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
CONFERENCE REPORT ON H.R. 3448, PUBLIC HEALTH SECURITY AND BIOTERRORISM
PREPAREDNESS AND RESPONSE ACT OF 2002
Mr. TAUZIN. Mr. Speaker, pursuant to House Resolution 427, I call up
the conference report on 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.
The Clerk read the title of the bill.
The SPEAKER pro tempore (Mr. Fossella). Pursuant to House Resolution
427, the conference report is considered as having been read.
(For conference report and statement, see proceedings of the House of
May 21, 2002 at page H 2691.)
The SPEAKER pro tempore. The gentleman from Louisiana (Mr. Tauzin)
and the gentleman from Michigan (Mr. Dingell) each will control 30
minutes.
The Chair recognizes the gentleman from Louisiana (Mr. Tauzin).
[[Page H2845]]
General Leave
Mr. TAUZIN. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days within which to revise and extend their remarks
on the legislation.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Louisiana?
There was no objection.
Mr. TAUZIN. Mr. Speaker, I yield myself 5 minutes.
Mr. Speaker, it is my privilege to bring before the House the
conference report to accompany H.R. 3448, the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002. This bill will
in short order help ensure America's health security, and I urge my
colleagues to join me in sending it to the President's desk.
I want to thank the gentleman from Michigan (Mr. Dingell), first of
all, the ranking minority member of our committee, who, together, with
our other members of our committee, put this bill together and secured
over 400 votes on this House floor last December for its passage. Now
we bring my colleagues back the conference report, bringing together
the best of the Senate bill, authored by Senator Ted Kennedy and
Senator Bill Frist, and I want to thank them on the Senate side for
their work.
Over 25 Members worked on this conference between the House and
Senate, and I want to also thank the Committee on Agriculture and
Committee on the Judiciary members, the administration, and the many
interested parties who have helped us draft this conference report.
Mr. Speaker, it is crucial that America's public health emergency
system be prepared to respond to the new and emerging threats, and we
are here to take care of that job today. The conference report makes
broad and dramatic investments in our public health infrastructure to
help secure our country and provide safety for the American people.
Let me emphasize a few areas. First of all, communications. The
conference report will improve communications between all levels of
government, public health officials, first responders, health care
providers and facilities during emergencies. It authorizes grants in
fiscal year 2002 and beyond in grants to State, local governments,
public and private health care facilities to improve planning,
preparedness, enhance laboratory capacity, educate and train health
care personnel.
It will make the Department of Health and Human Services, give it a
new focus so they can improve coordination and accountability through a
new Assistant Secretary for Emergency Preparedness. We will also ensure
that sufficient drugs, vaccines and other supplies are available for
our security.
It enhances those controls on deadly biological agents, agents to
help prevent bioterrorism to establish a database of dangerous
pathogens. It imposes new registration requirements on the most
dangerous of those agents and toxins and mandates tough new safety and
security requirements to ensure that only legitimate scientists working
on appropriate laboratory facilities can gain access to these potential
weapons of mass destruction.
The conference report also helps to protect the safety of America's
food supply. We are substantially increasing the resources of the FDA
so they can hire inspectors at borders and develop new methods to
detect contaminated foods. In addition, we are providing the Secretary
with the additional regulatory authority he has requested so that FDA
can detain foods where there is credible evidence that it is
contaminated or poses a threat to human beings.
H.R. 3448 will also ensure that drinking water systems across the
country assess their vulnerability to terrorist attacks and develop
emergency plans to prepare for and respond to such attacks. Americans
deserve to know that we are taking concerted efforts and action today
to protect the safe drinking water of our country.
Finally, Mr. Speaker, I am pleased to report that this bill contains
a reauthorization of the Prescription Drug User Fee Act, a critical act
that provides the money to test prescription drugs before they are
authorized by the FDA for use in our society.
Mr. Speaker, I urge my colleagues to support the conference report.
This is a critical, must-do piece of legislation to help this country
face the new threats we face, and I urge the adoption of this
conference report.
On December 20, 2001, Environment and Hazardous Materials
Subcommittee Chairman Paul E. Gillmor provided a detailed explanation
of Title IV for the Record as passed by the House. I want to expand
upon those remarks and note several aspects of this title as they have
been supplemented in conference with the Senate. As evidenced by the
conference report to accompany H.R. 3448, the Senate did not have any
comparable provisions to Title IV in their bioterrorism legislation.
Therefore, the House and Senate conferees utilized Title IV as passed
by the House as base text for the final provision.
In this regard, the first and most significant change agreed to by
the conferees was the requirement that community water systems submit a
written copy of their completed vulnerability assessment to the
Administrator of the EPA. The choice of ``written copy'' in this
context is intentional. Since vulnerability assessments contain highly
sensitive information, the conference report avoided any requirement or
option for electronic submissions and there is no authority for EPA to
put such information into its data systems or to create public access
of any kind. In addition, the submission requirement applies only to
copies of the assessment itself and does not include any supporting
documentation, work papers or other preparatory or analytical material.
Second, I would note that the Federal FOIA exemption covering these
submissions and information flowing from these submissions is complete;
all information and all information derived from these submissions is
exempt from disclosure. Moreover Title IV does not create ``FOIA
events'' at the state and local level since it provides that the
requirement to submit a vulnerability assessment to EPA does not create
any obligation under State and local law to submit a copy of the
assessment to any other governmental authority. And while it permits
U.S. officials to ``discuss the contents'' of the vulnerability
assessments with appropriate state and local officials, the substitute
does not authorize U.S. officials to provide copies of these
assessments to anyone, except as specifically provided in the bill.
Third, EPA is required to handle all submitted information under
strict security arrangements and protocols. These protocols are to
ensure that no one, other than specifically authorized personnel, have
access to any part of the submission or to information derived from the
submission. The only allowed exceptions to this restriction are for
specified actions under identified sections of the Safe Drinking Water
Act. Knowingly or recklessly violating these restrictions is subject to
criminal prosecution and fines.
Fourth, it is important to note that the conference agreement on
Title IV did not establish any new regulatory role or transfer any new
regulatory power to EPA. No new authorities were transferred to the
Agency beyond the passive receipt of vulnerability assessments under
Section 1433. As noted in the previous statement by
Subcommittee Chairman Gillmor, EPA has no power to promulgate
regulations or guidance to define what is an ``acceptable''
vulnerability assessment; there is only a one-time duty to provide
information to community water systems by August 1, 2002. In addition,
Section 1433 only defines a vulnerability assessment to the extent that
it includes a review of certain specified items, most of which are
based on the definition of a public water system under Section 1401 of
the SDWA. Thus, no community water system is required to use any
particular vulnerability assessment tool, to conduct any specific type
of analysis, to determine the consequences of any intentional or
terrorist acts, analyze the use of any specific chemicals or
characterize the risk of any offsite impacts.
In addition, Section 303 of the conference Substitute authorizes the
Secretary to detain a shipment of food where FDA has credible evidence
or information indicating that such food ``presents a threat of serious
adverse health consequences or death to humans or animals.'' This
section does not grant FDA authority to detain whole categories or
types of foods, rather it applies to specific shipments or articles of
food that the Secretary has credible evidence or information of, based
on an investigation, examination or investigation, that they present a
threat of serious adverse health consequences or death to humans or
animals. The ``serious adverse health consequences or death'' standard
that is used consistently in Title III, Subtitle A was drawn from title
21, Section 7.3 of the Code of Federal Regulations, relating to the
situation in which there is a reasonable probability that the use of,
or exposure to, a violative product will cause serious adverse health
consequences or death.
Furthermore, Section 307 of the Conference Substitute authorizes the
Secretary to develop a regulation for prior notice of food imports. In
developing such a regulation, the Secretary of
[[Page H2846]]
Health and Human Services should coordinate and consult with the
Secretary of Treasury regarding the notifications already required by
the U.S. Customs Service with the goal of eliminating, reducing or
consolidating duplicative or unnecessary notice requirements and
minimizing potential trade impacts of the prior notice requirements of
this section. Finally, Section 305 of the Conference Substitute does
not impose a registration fee.
In addition to my earlier remarks on Title II, I want to clarify two
other provisions contained in this important title. First, in both the
HHS and USDA regulatory program sections, the conference substitute
creates a new notification requirement whenever ``a release, meeting
criteria establish by the Secretary, has occurred outside of the
biocontainment area'' of a registered person's facility. As is clear
from the statutory text--``a release . . . has occurred''--this
provision covers actual releases, not threatened or possible releases.
Second, the phrase ``meeting criteria established by the Secretary'' is
meant to make clear that we are leaving it up to the two Secretaries to
determine, independently, the type or nature of releases to be covered
by this provision as it applies to each regulatory regime. We expressly
do not intend to incorporate the definitions and interpretations of the
term ``release'' as it is used in a Comprehensive Environmental
Response, Compensation, and Liability Act.
Finally, we create a ``(b)(3)'' statute exempting certain categories
of information relating to select agents from the Freedom of
Information Act (FOIA). Specifically, we bar disclosure under FOIA of
registration and transfer documents, including information derived
therefrom that could identify a registered person, or the agents being
stored by a registered person; security-related information; and
compilations of registration and transfer information. We also protect
site-specific information on inspection reports, provided that the
agency determines public disclosure would endanger public health and
safety. By adding this additional requirement for inspection documents,
we are striving to ensure a fair balance between public accountability
and security. When a registered person is publicly known to be working
with select agents, public disclosure of an inspection report is less
likely to endanger public health or safety (provided that security-
specific information is redacted), and may improve it by ensuring
public accountability. But when the activities of a registered person
are not publicly known, revealing the identity and location of a
registered person would more likely endanger public health or safety.
The agencies will need to consider such matters on a case-by-case
basis.
Mr. Speaker, I reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, I want to rise first to commend my good
friend and colleague, the gentleman from Louisiana (Mr. Tauzin), for
the distinguished work he has done not only on producing a good bill
but on producing a good bipartisan bill.
This is a good piece of legislation. Many have worked on it and I can
recommend it to the House without reservation. We bring them an
excellent legislation to the floor, a matter of great national
importance. This is going to improve our preparedness against
terrorism. All of us know why the legislation is needed, and now.
The bill, which was sponsored by the gentleman from Louisiana (Mr.
Tauzin) and I and a number of our colleagues, passed the House
originally by 418 to 2. The Senate bill, an excellent piece of
legislation, sponsored by Senators Kennedy and Frist, passed by
unanimous consent. It is, as I mentioned, an excellent bill.
The conference report we have now before us is a superb product,
thanks to the leadership of the gentleman from Louisiana (Mr. Tauzin)
and Senators Kennedy and Frist, as well as all of the conferees who
worked very hard on this legislation, and the staff, which deserves
great commendation for their labor.
The Act authorizes funds for planning, preparation, and response and
activity across the board to deal with those questions, with special
emphasis on the State and local level, an area where there is needed
and necessary concern. It is hoped that this bill will then make it
possible for those who will be provided in this bill and their funding
to move directly to the front lines where they are needed, and that
will include assistance in shoring up our frayed public health network
and our first responders, who are largely officers of the local and
State governments.
The bill has important new protections for the food supply of the
Nation, an area of particular and long-standing concern. We provide new
inspection resources for imported food, but these will only be a down
payment on what is ultimately going to be necessary.
Other new authorities are included in the report, registration and
detention provisions of the legislation which will help the Secretary
to manage imports more efficiently and effectively in the public
interest and in the interest of consumers.
There are many other excellent provisions, including improvement in
drinking water supply safety, tighter controls on dangerous biological
agents. These are important steps and they must be taken now.
Finally, we reauthorize the Prescription Drug User Fee Act which has
led to faster FDA approvals of prescription drug applications, and we
increase funding for drug safety efforts.
I repeat, this is a good bill. It is an excellent start as our Nation
works to improve its abilities to defend against an assault by enemies
using biologic agents and other kinds of agents to create danger,
hazard and death for our American people.
Mr. Speaker, I reserve the balance of my time, and I ask unanimous
consent to yield the balance of my time to the gentleman from Ohio (Mr.
Brown) for him to control on behalf of the minority.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Georgia (Mr. Norwood), a distinguished member of our
committee.
Mr. NORWOOD. Mr. Speaker, I just want to point out that this bill
represents a mammoth undertaking by the Committee on Energy and
Commerce, and I would like to compliment the hard work done by the
gentleman from Louisiana (Mr. Tauzin), the chairman, and the gentleman
from Michigan (Mr. Dingell), the ranking member, in bringing this
important legislation to the floor. It is something that we must pass,
we must get into law immediately, and I am delighted that we are doing
so in a bipartisan way.
There are things I would like to see different in this bill, as I
presume most Members would, but we simply do not have that luxury. We
have to find a way to protect the American people from bioterrorism
today with a bill that can become law immediately.
The gentleman from Louisiana (Mr. Tauzin) and the gentleman from
Michigan (Mr. Dingell) and too many others to mention have actually
found that way in this bill. This bill will provide additional support
for the Centers for Disease Control and Prevention, and I want to thank
the gentleman from Georgia (Mr. Chambliss), my good, dear friend, for
his work in that area, as well as the public and private health care
systems throughout America's local communities.
It will improve communication among all levels of government, which
is where we clearly have the greatest problem at present. It provides a
stockpile of sufficient drugs, vaccines and other supplies that we
found we were short of when forced to abandon our offices to anthrax
last year. It encourages a development of new drugs and vaccines to
combat bioterrorism, and it increases the security at our borders and
for our food and drug supplies and waterworks.
I compliment the chairman for getting the Prescription Drug User Fee
Act reauthorized through 2007 as an important precursor to solving the
long-term challenges of the prescription drug cost.
Mr. Speaker, we can make improvements later. We need action
yesterday. I urge the passage of this bill today.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself 4 minutes.
American lives depend on the strength and the reach and the
cohesiveness of our public health system. For far too long, we have
neglected our public health infrastructure, the men and women on the
front lines, and the resources they need to do their job.
This bill makes a new investment in the Nation's public health and
vaccines and in food safety. I am particularly gratified by the strong
language concerning antibiotic resistance and the
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very positive work we have done to improve the safety of imported food.
I want to recognize the hard work of staff who has been laboring over
this bill for several months, pulling some all-night sessions, long
weekend sessions. On the Committee on Energy and Commerce, Edith
Hollaman and John Ford and Bruce Guinn and Jonathan Cordone on the
minority; and with the majority, Nandan Kenkeremath, Amit Sachdev, Tom
DeLinge and Pat Morrisey; also with the gentleman from California's
(Mr. Waxman) office, Ann Witt; and especially three people in my
office, Ellie Dghongy, Katie Porter and Earl Seeley, for their
outstanding work on this very complicated and extraordinarily complex
issue.
{time} 1215
This legislation authorizes PDUFA, the Prescription Drug User Fee
Act. By increasing the resources available to FDA, PDUFA has enabled
the agency to reduce the time needed to assess safety and efficacy of
new prescription drugs. Expediting access to beneficial new medicines
is good for consumers and good for public health. However, more rapid
approval times, coupled with increasingly aggressive marketing by drug
manufacturers, all too often have safety consequences.
More new drugs in the marketplace, more Americans taking these drugs
due to the barrage of direct-to-consumer advertising, if a lethal side
effect surfaces once a new drug hits the market, millions of Americans
are affected. That is why it is critical to bolster FDA's drug safety
capabilities. One of the most important provisions in this bill enables
FDA to devote a portion of the user fees it collects from the drug
industry to enhance its pre- and post-market drug safety functions.
We took steps to ensure that the focus on rapid approval time does
not put pressure on FDA to drain resources from other important
functions, like drug safety, like the review of drug advertising, and,
importantly, the review of generic drugs. We also laid the groundwork
for improving the process by which drug user fees are established.
The public interest is never served when a regulatory body and the
industry it regulates get too close. FDA depends on user fees from the
industry it regulates, consumers depend on FDA to focus on public
health and public safety, not on drug industry profits. FDA has
established performance goals to demonstrate that it is applying the
user fees in an effective manner. Historically, the drug industry and
FDA have jointly established these goals behind closed doors.
We have taken steps to make sure consumers are part of that process.
Regardless of where the revenues come from, FDA's responsibility is the
consumer, not the drug industry, something they need to always
remember. Any and every goal it sets should reflect that fact.
Mr. Speaker, I want to briefly mention one disappointment in this
process. Last year, we passed legislation giving the drug industry a
patent extension if they conduct tests to make sure their drugs are
safe in children. Some of us question why the Federal Government had to
bribe drug companies in order to get them to do tests that should be
mandatory. We know many new drugs are prescribed for kids now. We know
doctors are forced to fly blind, making decisions about the right
medicine, the right dose, without the benefit of clinical testing.
We were told the patent extension incentive was important to get drug
companies to conduct tests on drugs already on the market, but that the
bill did not supplant FDA's authority to require the testing for new
drugs. Well, it appears the drug industry and my Republican colleagues,
who on this issue apparently are doing its bidding, have changed their
mind. The administration has waffled on whether to maintain the
regulations that affirm the testing requirement.
My colleague, the gentleman from California (Mr. Waxman) has
introduced legislation to codify that requirement, in other words, to
ensure that children receive the proper drugs in the proper dosage. If
we could depend on the drug industry to make sure their drugs are safe,
the drug industry would not be fighting regulations that require them
to do so.
Other than those small number of criticisms, Mr. Speaker, this is
good legislation.
Mr. Speaker, I reserve the balance of my time.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Florida (Mr. Bilirakis), the chairman of the
Subcommittee on Health of the Committee on Energy and Commerce.
Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me
this time, and I rise in support of the conference report.
This important legislation strengthens our ability as a country to
detect and respond to bioterrorist threats or attacks. Just this week,
the Vice President stated that another terrorist assault is almost
certain. Therefore, Mr. Speaker, it is crucial that we quickly pass
this legislation and send it to the President for his signature.
The legislation is a strong and comprehensive measure that enhances
the security of our Nation. First, we strengthen our public health
systems by increasing State and local preparedness to detect and
respond to an attack. Secondly, this bill enhances security measures in
relation to the handling, transport and storage of dangerous
substances. Third, we strengthen our Nation's food security systems.
And, fourth, we improve the safety and security of our drinking water
systems.
Mr. Speaker, this is a comprehensive approach and a meaningful step
to improve our Nation's security systems. The conference report
includes provisions to reauthorize the Prescription Drug User Fee Act.
This is critically important, because without this program the Food and
Drug Administration would have lost millions of dollars and numerous
personnel which are used to review and approve lifesaving medicines. I
am very pleased we worked in a truly bipartisan, bicameral manner to
reauthorize this program.
Unfortunately, we were not able to reach resolution on medical device
changes. But I am committed, Mr. Speaker, I like to think we all are,
to working to update device laws this year.
I want to take a moment to thank the staff who worked so hard to
complete this legislation, particularly to single out Pete Goodloe, the
House's Legislative Counsel. We would not have been able to complete
this legislation in a timely fashion without his expert services.
Unfortunately, there are so many other staff that have worked so
hard, I am unable to name each of them here today. But please know that
our country will be better prepared in the future because of your hard
work.
Mr. Speaker, this is a strong measure supported by all the conferees,
and I urge my colleagues to support this conference report.
Mr. BROWN of Ohio. Mr. Speaker, I yield such time as he may consume
to my friend, the gentleman from Texas (Mr. Stenholm).
(Mr. STENHOLM asked and was given permission to revise and extend his
remarks.)
Mr. STENHOLM. Mr. Speaker, I rise in support of H.R. 3448.
Mr. Speaker, I rise today in support of H.R. 3448, the Bioterrorism
Preparedness Act conference report. I appreciate the work that Chairman
Tauzin and Ranking Member Dingell have put into this bill, and I want
to thank them both for the respectful and helpful way they have dealt
with concerns raised by the agricultural community.
However, I do need to express my concerns about the thoroughness of
the process in regard to many provisions under the jurisdiction of the
House Agriculture Committee. I would have been much more comfortable
with a more deliberative process, including a hearing record and
outside input.
The conference report includes significant changes in the following
areas: the regulation of biological research facilities; changes in the
way our food is inspected; changes to human and animal disease
monitoring efforts, and many more.
Many of the provisions of this conference report appear to be needed,
and are very logical in light of our Nation's current security
concerns. For example, language in this agreement to coordinate and
enhance our control of dangerous biological agents and toxins is
certainly timely and important. In addition, this conference agreement
contains needed authorizations to upgrade and secure facilities working
with biological agents, both for human and animal disease research.
Given the importance of these issues, along with the willingness of
the other conference
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members to make a few important changes to the bill, I am going to
support the conference agreement. Still, I feel I must reiterate that
it would have been better if many of the provisions in this agreement,
the majority of which are not emergency in nature, had gone through a
more thorough and regular legislative process.
Given the reality of the choices before us today, and the importance
of some of the provisions in this legislation, I urge Members to
support passage of the conference report.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentlewoman
from California (Ms. Harman), a member of the committee.
Ms. HARMAN. Mr. Speaker, I thank the gentleman for yielding me this
time; and I hope that he will add my staffer, Carolyn Cobberly, to the
list of brilliant staffers who have added to this legislation.
Mr. Speaker, serving on the Committee on Energy and Commerce is a
high honor. The chance to work on impressive bipartisan legislation
like this is why I came to Congress.
The possibility of another bioterrorist attack is real and our Nation
must be prepared to respond. Our top priority must be to develop a
national strategy to identify the most likely threats and prioritize
our response. We already know that al Qaeda and rogue states like Iraq
have attempted to acquire biological agents, and we have yet to
discover and prosecute the individual or group responsible for the
anthrax attacks that killed five people in October and November.
Our government's response to the bioterrorist attacks of October and
November was deeply flawed. We have talented people, but we have been
lacking the resources and coordination to make our response effective.
We must act now to improve our terrorism response before another
tragedy occurs.
This legislation moves us in the right direction. It creates lines of
communication and organizations to coordinate the roles that our public
health agencies, military, and FBI will play in bioterrorism response.
It also directs substantial investments to the State and local
governments that need it most. All terrorism is local, and our response
must be local. This bill provides resources where they are needed most.
I am particularly glad that this bill includes funds to speed up the
renovation of CDC's buildings and facilities. I have visited the
Centers for Disease Control and Prevention in Atlanta and seen talented
people working there in the shabbiest conditions. This legislation
authorizes $300 million in each of the next 2 years to improve the
security of CDC facilities and construct much-needed research
facilities.
I am also glad this bill will increase our investment in improving
the IT capabilities of public health agencies across the Nation. One-
third of public health agencies are not connected to the Internet. If
we are to communicate effectively, we need to develop comprehensive,
syndromic surveillance systems to detect the outbreak of diseases, and
we need to have all public health agencies on line.
This bill is excellent legislation, and I urge its passage.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 5 minutes to the
gentleman from North Carolina (Mr. Burr), the distinguished vice
chairman of the full committee.
Mr. BURR of North Carolina. Mr. Speaker, I thank the chairman of the
Committee on Energy and Commerce for yielding me this time.
At this time, Mr. Speaker, let me recognize the tremendous work of
the chairman, of the ranking member, the gentleman from Michigan (Mr.
Dingell), Senator Kennedy, Senator Frist, who headed the Senate side,
but more importantly the great work of committee and personal staffs of
all the Members who served on that conference. This was not an easy
thing to hammer out. It took many late nights on the part of staff.
There was a lot of give and take; but it meant that something that was
important to this country, something that was timely and urgent,
actually got addressed in a sufficient way.
Mr. Speaker, I rise today in support of the conference report. This
legislation has been long in the making and is long overdue when we
look at what we have gone through. But H.R. 3448 puts in motion the
resources, $4.6 billion in 2 years, and authorities needed to close the
gaps in our Nation's public health infrastructure.
I would like to speak briefly about a few of the many important
provisions included in this bill. I am grateful that the managers
agreed to retain the provisions authorizing the National Medical
Response System. These provisions are built around legislation
introduced earlier and recognize the critical role played by personnel
of the National Disaster Medical Response Teams in responding to all
disasters, not just bioterrorism. The members of the National Disaster
Medical Response Teams are nearly all volunteers who are called away
from their real jobs on a moment's notice, and they deserve the
liability and job protections we extend to them in this bill.
I am also pleased the managers recognized the need to revitalize and
modernize the lab facilities and other buildings at the Centers for
Disease Control. This section, which builds on the hard work of the
gentleman from Georgia (Mr. Chambliss), the gentlewoman from California
(Ms. Harman), and the gentleman from Georgia (Mr. Linder) and their
bill H.R. 3219, authorizes a dramatic ramp-up in our facility spending
for the CDC.
The legislation also takes into account the central role played by
the centers in operating and maintaining a robust public health
communications and surveillance system that we were shocked to find out
was not electronically connected to every public health entity in this
country. But after this bill, it will be connected. The centers are a
national asset, and they need our support in order to carry out their
very important mission.
The grant program authorized in this legislation, Mr. Speaker, is the
real heart of this bill. Building on the work being done on an
emergency basis by the administration, these grants will enable our
State and local governments as well as hospitals to train personnel,
purchase needed equipment, and strengthen the communication and disease
surveillance that they have done up to this point. It is our hope
spending in these areas will not only help improve our ability to
respond to bioterrorist attacks but also strengthen critical elements
in our overall public health system.
The bill also tightens control on access to dangerous biological
agents and toxins by establishing a reporting and tracking system that
was not in place. We do not mean to introduce these provisions to be
burdensome on researchers, but as we have learned post-September 11,
our ability to know where these agents and toxins are is vitally
important.
Title 3 strengthens the safety of the food and drug supply in the
United States. I believe that with subsequent regulations from HHS, we
found a balance between information requirements and information
activities. None of us want to make it a burden to import food and bulk
drugs. But after 9-11, we realized we have to have a better handle on
the items that cross our borders and where they are.
In this legislation, Mr. Speaker, we also reauthorize the
Prescription Drug User Fee Act. The last time we reauthorized this act
was when we passed the food, drug modernization act in 1997. This time,
PDUFA is reauthorized with increased emphasis on post-market
surveillance and generic drug review. The FDA and patients across the
United States will benefit greatly from this legislation and that
reauthorization.
Finally, let me once again extend my thanks to the many personal and
committee staffs on both sides of the Hill who put really invaluable
time into working out the differences on this. Like many others, it is
not perfect; but it is pretty darn good. It is this legislation will go
a long way in restoring the viability of our Nation's public health
infrastructure at a time when it is vitally needed.
Mr. Speaker, today I urge my colleagues to support this conference
report, support the good work of the House and the Senate, and let us
move forward with rebuilding things that we know now we need to
rebuild.
Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentleman
from Massachusetts (Mr. Markey).
{time} 1230
Mr. MARKEY. Mr. Speaker, the litany of saints has been mentioned of
staffers who have worked on this bill. I
[[Page H2849]]
would like to add just two more: one is Jeff Duncan, who is my
legislative staff director; the other is Kristen Kulinowski, who is in
the gallery right now with her mother and father and husband, who
worked on the provision that will provide for the Federal Government to
give to the States or to local communities who request it the potassium
iodide which would serve as the antidote to thyroid cancer which is the
very real and greatest danger in the event of a successful attack of a
bioterrorist group at a nuclear power plant or an unwanted accident at
a power plant.
And so this is a huge step forward, which I believe is going to
really increase public health and safety. I want to thank the majority
for their great assistance on this and thank all the people in the
minority as well for their great help.
Mr. Speaker, I rise to commend the conferees for their hard work on
this important bill. H.R. 3448 includes a provision of mine that will
take an important step toward protecting public health in the event of
an act of terrorism at our Nation's nuclear power plants. I thank Mr.
Tauzin for working with me in the House Energy and Commerce Committee
to include a provision on stockpiling potassium iodide to protect
public health in the event of a successful terrorist attack against a
nuclear power plant. Potassium iodide is a safe and effective drug that
protects the thyroid gland by saturating it with a safe form of iodine
so that it cannot absorb the radioactive iodine produced during the
plant's normal operation.
My provision, which was adopted in committee and passed by the House
with broad bipartisan support, will provide greater protection of
public health than existing programs. The Nuclear Regulatory Commission
has a voluntary program that provides States with free potassium iodide
for people within 10 miles. However, a State must submit a formal
request to the NRC to get the free pills, and some States have refused
to do so. My provision allowed States or local governments to request
potassium iodide for people within 20 miles of these plants, thus
expanding the radius of protection beyond the 10-mile emergency
planning zone, and would have allowed local governments to request this
important protection even if the State had refused to accept the NRC's
offer.
The bioterrorism bill that was passed by the Senate had no potassium
iodide provision, so we worked together in conference committee to
produce the amended provision under consideration today in title 1,
section 127. This amended provision directs the President to provide
potassium iodide to States and local governments, and provides a
mechanism for local governments to request the pills where the State
has not done so. The local government is eligible to request potassium
iodide from the President only if the State government does not have a
plan for stockpiling or has a plan that does not go beyond 10 miles.
The local government must first petition the State to modify the
State's plan to include the population requested by the local
government. If the State does not modify its plan, the local government
must submit a stockpiling and distribution plan to the State and the
State must certify that the local government's plan is not inconsistent
with the State's emergency plans.
In addition, the conferees agreed to commission a study by the
National Academies on the most effective and safe way to distribute and
administer potassium iodide on a mass scale. I wish to make clear that
this study will not consider the overall safety and efficacy of
potassium iodide as a medical preventative to thyroid diseases caused
by exposure to radioactive iodine. The Food and Drug Administration,
Nuclear Regulatory Agency, and Federal Emergency Management Agency have
all concluded that potassium iodide is safe and effective. In fact, the
FDA has stated that the risks of radiation-induced thyroid cancer in
children so far outweigh the negligible risk of side effects, that it
is better for a child to take a full adult dose than to take no
potassium iodide at all. Thus, the study will only address how best to
incorporate potassium iodide into a comprehensive emergency plan that
may include evacuation and sheltering.
One thing I would like the National Academies study to consider is
whether a 20-mile radius goes far enough to protect people in the event
of a core melt-through plus breach of containment. The Nuclear
Regulatory Commission's own documents show a significant risk to the
thyroid as far away as 200 miles from the plant in such a scenario, yet
the official evacuation zone only extends to 10 miles. The NRC disputes
this documentation yet has failed to produce for me any new studies
that justify the 10-mile zone. The Chernobyl accident resulted in
increased thyroid cancers hundreds of miles from the plant. I would
strongly recommend the National Academies study whether 20 miles is
sufficient.
While this provision doesn't go as far as I would like, it is an
important first step in expanding the radius of protection from nuclear
terrorism. I thank all the members of the conference committee who
worked on this bill and I urge my colleagues to vote for its passage.
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (Mr. LaHood). The Chair would remind Members
not to refer to people in the gallery.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the
gentleman from Illinois (Mr. Shimkus), a distinguished lieutenant
colonel.
(Mr. SHIMKUS asked and was given permission to revise and extend his
remarks.)
Mr. SHIMKUS. Mr. Speaker, the committee and our work, especially the
Committee on Energy and Commerce, is two-for-two, 2 days in a row, two
good bills, bipartisan agreement. I want to applaud both our majority
side and our colleagues on the other side for two good pieces of
legislation.
Since the attacks of September 11 and the recent anthrax exposures,
our Nation has had to reevaluate its ability to respond to a
bioterrorism attack. The anthrax attacks, though small in scale
compared to the scenarios envisioned by bioterrorism experts, strained
the public health system and raised concern that the Nation is
insufficiently prepared to respond to bioterrorist attacks. Improving
public health preparedness, food safety protection, and response
capacity offers protection not only from bioterrorist attacks but also
from naturally occurring public health emergencies.
This conference report substantially improves our country's ability
to plan and prepare for such an emergency. It increases the ability of
the Federal Government and communities to plan for any future
biological emergencies. This includes improving communications and the
public information flow, updating lab capabilities, authorizing a
national stockpile, and assisting our health care providers to be
prepared to provide care.
In particular, Mr. Speaker, title II of this legislation creates a
list of all biological agents and toxins and regulates which
individuals can work with them. As many of the Members are aware, the
Justice Department will start giving lie detector tests to hundreds of
current and former Federal employees who worked at two Federal
facilities where anthrax was kept. One former researcher at one of the
labs said that nothing was in place to prevent workers from removing
the deadly germs from the labs. This legislation will make sure that
the government is well aware where these dangerous toxins and agents
are being researched and stored and exactly who will be doing the
research. If this provision had been in place prior to last year, the
anthrax attacks might have been prevented.
In addition, title I of this bill includes a provision that addresses
health personnel shortages that would impact the ability of the Nation
to respond during a bioterrorism attack. The bill establishes grants
for training and education of these critical health care providers.
I ask for full support of this bill.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentlewoman
from California (Mrs. Capps), a registered nurse who is on our
committee.
Mrs. CAPPS. I thank my colleague for yielding time.
Mr. Speaker, I rise in support of the conference report on the
bioterrorism preparedness bill. This bill is a good example of what we
can accomplish when we work together. The bill we produced under the
leadership of Chairman Tauzin and Ranking Member Dingell will
strengthen our public health infrastructure and make a much-needed
increase in resources for food and water safety and security.
I am very pleased that one of my bills, the Community AED Act, was
included in this legislation. I introduced this bill earlier this year
with my colleague, the gentleman from Illinois (Mr. Shimkus). It will
help local communities place automatic external defibrillators in
public places. Quick access to AEDs can mean the difference between
life and death for victims of sudden cardiac arrest. Making sure AEDs
are readily available will improve our ability to cope with public
health emergencies.
I am also pleased that this bill sets aside funds to train health
care workers to identify and treat symptoms of bioterrorism. And it
provides the Secretary of Health and Human Services
[[Page H2850]]
with a small pool of funds to address workforce shortages. But as a
part of our goal of preparing for bioterrorism, we still need to do
more to address the shortage of nurses. Nurses, for example, will be
called upon to deal with patients who may have been infected by a
biological agent, and we do not have enough nurses. That is why I have
been working with Chairman Tauzin, Chairman Bilirakis, the gentleman
from Michigan (Mr. Dingell), the gentleman from Ohio (Mr. Brown), and
others in the House and Senate to complete the Nurse Reinvestment Act
passed here last year. The passage of this nursing legislation as a
complement to the bill before us today is essential to making us ready
for bioterrorism.
I am pleased that Chairman Tauzin and Chairman Bilirakis have given
me their assurances that we will finish this bill by the end of June.
These bills together can help our Nation be ready for tragedies we do
not even want to imagine.
I urge my colleagues to support this bioterrorism bill and commit to
final passage of the Nurse Reinvestment Act.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from South Dakota (Mr. Thune) from the Committee on
Agriculture which contributed a great deal to this bill.
Mr. THUNE. Mr. Speaker, I thank the gentleman for yielding time. I
want to commend the gentleman from Louisiana (Mr. Tauzin) for his hard
work in bringing together different bills in a bipartisan way that meet
the public health threats that we face as a Nation. I particularly want
to thank both Chairman Tauzin and Chairman Combest for including
language in this bill to authorize an agricultural bioterrorism early-
warning surveillance system for animal diagnostic laboratories. This
network will provide early detection of bioterrorist events, natural or
intentional contamination of our food supply, animal disease outbreaks
involving agents which impact human health and early recognition of
newly emergent and economically important diseases such as foot and
mouth disease. The network will also enhance coordination between State
and Federal laboratories as well as public health agencies. In my
State, South Dakota State University will benefit greatly from this
particular provision.
Mr. Speaker, the infrastructure our Nation needs to protect and
prepare itself for bioterror attacks cannot be overlooked. This
legislation meets those needs so that people across our Nation can feel
safe and secure with the understanding that should the worst happen, we
will be ready.
I ask my colleagues to support the conference report.
Since the attacks of September 11th we have all become far more
sensitive to the threat of a bioterrorist attack here at home. It is
critical that our citizens feel secure at home, that our first
responders are properly trained and prepared and that the food that
crosses our borders is safe.
I want to thank my colleague Chairman Billy Tauzin for his hard work
to bring two different bills together in a bipartisan compromise that
meets the public health threats we face as a Nation. This bill uses new
ideas and new resources to help government officials at every level
prepare for bioterrorist threats and public health emergencies.
The bill authorizes more than $1.5 billion in grants to improve
bioterror planning and preparedness and to develop new drugs, therapies
and vaccines.
The bill authorizes $300 million for the Centers for Disease Control
and Prevention to upgrade and improve their facilities and
capabilities.
The bill authorizes more than $1.15 billion for the Secretary of
Health and Human Services to expand medicine stockpiles and the
purchase of additional small pox vaccines.
The bill also grants authority to USDA to impose new registration
requirements to regulate those agents that are most devastating to
crops and livestock. Additionally, the bill creates tough new criminal
penalties to enforce these important new regulations.
Importantly, the bill authorizes $545 million for FDA and USDA to
hire hundreds of new inspectors at our borders and to develop new
methods to detect contaminated foods. The bill also provides new
regulatory powers to FDA to safeguard our food supply. These new
resources and authorities will substantially improve the federal
government's ability to ensure the safety of America's food supply.
Finally, I would like to thank both Chairman Tauzin and Chairman
Combest for including language to authorize an agricultural
bioterrorism early warning surveillance system for animal diagnostic
laboratories. This network will provide early detection of bioterrorist
events, natural or intentional contamination of our food supply, animal
disease outbreaks involving agents which impact human health and early
recognition of newly emergent and economically important diseases such
as Foot and Mouth Disease. The network will also enhance coordination
between State and Federal laboratories, as well as public health
agencies. In my state, South Dakota State University will benefit
greatly from this provision.
Mr. Speaker, the infrastructure our nation needs to protect and
prepare itself for bioterror attack cannot be overlooked. This
legislation meets those needs so that people across our Nation can feel
safe with the understanding that should the worst happen we will be
ready.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman
from New Jersey (Mr. Pallone), who is a leading force on the
Subcommittee on Health.
Mr. PALLONE. Mr. Speaker, I rise today in support of the conference
report. As a conferee on title IV, the drinking water security and
safety provisions, I am very pleased with the compromise that was
reached. Title IV of this bill includes strong provisions that will,
first, require community water systems to conduct detailed assessments
of their vulnerability to attack by terrorists and of available
remedies; and, second, require EPA experts to review the findings of
the vulnerability assessments.
An FBI warning issued in January of this year notified water
officials that Osama bin Laden's al Qaeda network had considered and
investigated the possibility of attacking water distribution systems.
That is why my colleagues and I thought it was absolutely critical that
the final bioterrorism legislation address this issue.
The final bill assures that all vulnerabilities to terrorist attacks,
including attacks intended to contaminate the water supply and to
release chemicals into neighboring communities, are identified and that
available safety measures are evaluated. The bill accomplishes this by
requiring community water systems serving over 3,300 persons to conduct
vulnerability assessments. Each community water system must certify to
the administrator of the EPA that they have conducted a vulnerability
assessment. The administrator is also required to provide baseline
information regarding which kinds of terrorist attacks or other
intentional acts are probable threats. Then these vulnerability
assessments, once completed, will be sent to the EPA for secure keeping
and to help the government understand the threats to our water systems
and develop plans to protect our safe drinking water supply. We
authorize $160 million through fiscal year 2005 for this goal.
I want to thank the gentleman from California (Mr. Waxman). The
language in title IV is a tremendous improvement over the House-passed
bill. I would also like to thank the conferees and the staff on the
Democratic side, Dick Frandsen, also Greg Dotson with the gentleman
from California's office, and Heather Zichal with my office.
This is a good bill. I urge its passage.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from Indiana (Mr. Buyer), a distinguished and valued member
of the Committee on Energy and Commerce.
Mr. BUYER. Mr. Speaker, I would like to thank Chairman Tauzin and
Ranking Member Dingell for their diligence and hard work on the
conference report. Also after September 11 as we were coming together
to put together a bioterrorism bill, Chairman Tauzin gave me an
assignment. Given my expertise with regard to the Department of Defense
military health delivery system and the VA, it was to actually draft a
medical education piece, a component of this bill. The expertise with
regard to how to identify and treat chemical and radiological agents
and biological toxins and pathogens rests with the Department of
Defense. We have taken this knowledge from the DOD and moved it into
the VA because of the VA's nexus as teaching hospitals. We are not
going to establish new community standards of medical practice, that is
what is extremely important here, but we are going to make sure that
our first responders, our doctors, are able to identify and treat these
new threats in the future. That is what this bill does.
[[Page H2851]]
I want to thank the chairman and the gentleman from Michigan for
their hard work at the conference, along with the gentleman from Ohio
(Mr. Brown). I appreciate their work.
Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentleman
from California (Mr. Waxman), whose two staff people, Karen Nelson and
Tim Westmoreland, did particularly outstanding work. He was on the
conference committee with the gentleman from New Jersey (Mr. Pallone).
Mr. WAXMAN. Mr. Speaker, I thank the gentleman for yielding me time.
I want to congratulate the leadership of our committee on both the
Republican and the Democratic side and all the staffs who worked on
this legislation and urge support for the conference report. It
includes many valuable provisions that deserve our support. In
particular, it provides significant funding to the Centers for Disease
Control and Prevention and to State and local public health systems and
hospitals to improve their ability to respond to bioterrorist attacks
and other public health emergencies.
The report also includes important new food safety authority to the
Food and Drug Administration, authority that will be essential in the
event of a bioterrorist attack.
I am also pleased that we were able to make significant improvements
to title IV of this legislation to help protect the Nation's drinking
water from terrorist attack. Under these provisions, community water
systems will prepare vulnerability assessments and provide these
assessments to EPA. EPA will then be able to use the assessments to
address the threat of terrorism and for any other lawful purpose. These
provisions are a step forward. I am glad they have been included in
this legislation.
This conference report includes many valuable provisions that deserve
our support. In particular, it provides significant funding to the
Centers for Disease Control and Prevention and to State and local
public health systems and hospitals to improve their ability to respond
to bioterrorist attacks and other public health emergencies.
The report also includes important new food safety authority to the
Food and Drug Administration--authority which will be essential in the
event of a bioterrorist attack. The report authorizes the FDA to:
Require food companies to register with the FDA their names and
locations; detain food if there is information that it may present a
serious risk to health, either at the border or in domestic commerce;
require importers to give the FDA prior notice that a food will be
coming into the US; require food companies to keep records that will
assist the FDA to trace contaminated food; and inspect food
establishments when there is a reason to believe that they are holding
food that presents a serious risk to health.
We were also able to make significant improvements to Title IV of
this legislation to help protect the nation's drinking water from
terrorist attack. Under these provisions, community water systems will
prepare vulnerability assessments, and provide those assessments to
EPA.
EPA will then be able to use the assessments for a number of critical
purposes: To ensure that vulnerabilities are being adequately assessed;
to ensure that federal grants are awarded appropriately; to conduct
thorough inspections under the Safe Drinking Water Act; to address
significant vulnerabilities under section 1431 of the Safe Drinking
Water Act; to share with law enforcement and intelligence agencies; and
for any other lawful purpose.
I would also note that the report contains reauthorization of the
Prescription Drug User Fee Act. For the first time, we have included
provisions that will allow the FDA to use user fee money to watch over
the safety of drugs after they are marketed. This is of great
importance, particularly at a time when questions have been raised
about whether faster drug approvals have undercut drug safety.
These provisions are a step forward, and I am glad they have been
included in this legislation.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from Ohio (Mr. Gillmor), the distinguished chairman of the
Subcommittee on Environment and Hazardous Materials of the Committee on
Energy and Commerce.
Mr. GILLMOR. Mr. Speaker, I want to commend Chairman Tauzin, Ranking
Member Dingell, and the others who have worked so hard to produce a
conference committee report that certainly I am in very strong support
of.
In particular, I want to highlight the need to support the drinking
water protection provisions contained in title IV. Just yesterday,
newspapers were running front page stories about New York City worrying
about the vulnerability of their water system. As chairman of the
Subcommittee on Environment and Hazardous Materials, I am pleased that
our committee is tackling that issue, which is a serious concern not
only of some of our biggest systems but some of our medium and small-
sized systems as well.
I believe the original House language on title IV was preferable to
the provisions in the conference report, but I am glad we were able to
retain the core features of the House bill. Specifically, we require
drinking water systems to do vulnerability assessments and to compile
emergency response plans. In addition, we provide money for mandates
and establish emergency funds.
I strongly support the bill.
As chairman of the Environment and Hazardous Materials Subcommittee
of the House Energy and Commerce Committee, which has jurisdiction over
the Safe Drinking Water Act, I am taking this opportunity to elaborate
on and clarify the provisions of the conference report on Title IV of
H.R. 3448, the Public Health Security and Bioterrorism Preparedness
Response Act of 2002. I want to provide a more detailed explanation of
Title IV for the Record.
Title IV of the Public Health Security and Bioterrorism Preparedness
Response Act of 2001 requires community water systems serving over
3,300 individuals to conduct vulnerability assessments and to prepare
or revise emergency response plans which incorporate the results of the
vulnerability assessment. The legislation, however, also recognizes
that many community water systems have conducted or will be in the
process of conducting vulnerability assessments at the time of
enactment. Title IV is thus explicitly drafted not to create a
regulatory program which could slow down ongoing efforts or to require
systems that have completed vulnerability assessments to undertake
another such assessment. The title only requires that systems certify
that an assessment has been completed by a specific date, not that the
assessment was initiated and/or completed before or after the date of
enactment. Moreover, the title only requires that systems submit a
written copy of the assessment to the Administrator of EPA. Thus, the
title does not require that any preparatory or supplementary material
or analysis be provided to the Agency.
By only requiring submission of a written copy, Title IV recognizes
that vulnerability assessments can contain highly sensitive information
which would pose a danger if disclosed. The conference agreement on
Title IV did not include any requirement or option for the submission
of these assessments in electronic form. This recognizes that the
information protocols required under Title IV will tightly control
access to the assessments and that these documents will not be
available or placed on EPA electronic systems which have been
demonstrated to be vulnerable to unauthorized access.
Title IV requires strict security arrangements, procedures, equipment
and locations be established at EPA before the Agency shall receive the
submitted written copies of vulnerability assessments. These protocols
are to ensure that no one, other than specifically authorized
individuals, have any access to any part of the submission or to
information derived from the submission. Only very specific exceptions
to these restrictions are allowed under Title IV and knowingly or
recklessly violating these restrictions carries with it criminal
sanctions of both imprisonment and fines.
Title IV does not create a regulatory role for the Environmental
Protection Agency (EPA) in defining what is or is not an acceptable
vulnerability assessment. EPA is provided no regulatory authority in
this regard; instead, the Agency is only to provide information once to
community water systems (by August 1, 2002) regarding what kinds of
terrorist attacks are probable threats. EPA is to coordinate its
efforts with other agencies and departments of government who have
expertise in this area, to compile information readily available or
already developed, and to promptly distribute this information. The
statute does not provide a continuing duty for EPA in this area past
the date specified in the legislation.
In this regard, vulnerability assessments are defined in statute only
to the extent that they include a review of certain specified items.
These items are those which make up the physical structure of a public
water system (as defined in section 1401 of the Safe Drinking Water Act
(SDWA)), electronic, computer or other automated systems, physical
barriers, the use, storage, or handling of various chemicals and the
operation and maintenance of a drinking water system. Title IV
recognizes that there are many different types and sizes of community
water systems (CWS) and gives CWS wide discretion to devise and conduct
a vulnerability assessment. EPA is not given any
[[Page H2852]]
rulemaking or other authority to define further what is or is not a
vulnerability assessment meeting the requirements of section 1433. Nor
does Title IV require that a community water system utilize any
particular vulnerability assessment tool, or conduct any specific type
of analysis. Community water systems are not required to determine the
consequences of intentional acts or terrorist acts, analyze their use
of specific chemicals, including chlorine, as opposed to other
chemicals, or to characterize the risk of any offsite impacts. Further,
the term ``physical barriers'' does not necessarily include ``buffer
zones'' or any other area around physical structures.
Title IV recognizes that vulnerability assessments could contain very
sensitive information about a drinking water system which would be of
assistance to a terrorist or an individual contemplating an attack.
Therefore, Title IV provides a full, complete and airtight exemption
from disclosure under the federal FOIA requirement (5 U.S.C. 552) for
all information submitted to EPA and any information derived therefrom.
Further, the Title addresses the situation where a state or local FOIA
requirement could be ``triggered'' by submission of a written copy of a
vulnerability assessment to EPA. The Title provides that no community
water system will be compelled to submit a copy of the vulnerability
assessment to any governmental entity that is occasioned by the
requirement that the system submit such assessment to EPA.
Title IV does not contain any requirement that the EPA or any other
governmental body receive for review emergency response plans prepared
by water systems. Nor does Title IV contain any requirement that
community water systems provide such information to EPA or to any other
person or governmental entity. Community water systems are to
coordinate with local emergency planning committees (LEPCs) in the
preparation or revision of emergency response plans for the purpose of
avoiding duplication of effort and taking advantage of previous
information developed by the LEPCs for first responders and local
government response. There is no requirement that community water
systems disclose any of the information developed by the vulnerability
assessments to the LEPCs.
The legislation authorizes EPA to provide financial assistance to CWS
for several specified purposes. EPA may provide assistance for
vulnerability assessments, for developing or revising emergency
response plans and for expenses and contracts designed to address basic
security enhancements of critical importance and significant threats to
public health. The Title also authorizes assistance for small water
systems and immediate and urgent security needs, subject to limits
specified in the Title. Title IV does not define either ``basic
security enhancements of critical importance'' or ``significant threats
to public health.'' However, existing SDWA programs which provide
assistance to water systems have not provided assistance for continuing
expenses such as operations and maintenance or personnel expenses. This
legislation does not change this long-established public policy and
specifically indicates that basic security enhancements do not include
expenditures for personnel costs, or monitoring, operation or
maintenance of facilities, equipment of systems.
Finally, Title IV clarifies that EPA has discretion to act under Part
D, Emergency Powers, of the Safe Drinking Water Act (SDWA) when the
Agency has received information about a specific threatened terrorist
attack or when the Agency has received information concerning a
potential terrorist attack (but not necessarily a specific, identified
threat) at a drinking water facility. In exercising this discretion,
the EPA should only rely upon substantial, credible information. EPA
should not interpret ``potential terrorist attack'' to mean that there
is merely some possibility or statistical probability of a terrorist
attack. Neither should EPA interpret a general warning, general
announcement or general condition to be sufficient information of a
threatened or potential terrorist attack. Specific, credible
information is required, and all other elements of section 1431 must be
met, including the existence of an imminent and substantial
endangerment to the health of persons, that appropriate State and local
authorities have not acted to protect the health of persons served by
the drinking water system, and that the EPA Administrator has consulted
with State and local authorities regarding the correctness of the
information regarding both the specific threat and the actions which
the State or local authorities have taken. The authority granted to EPA
in section 1431 is a limited, case-by-case, contingent emergency power.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman
from Texas (Mr. Bentsen).
(Mr. BENTSEN asked and was given permission to revise and extend his
remarks.)
Mr. BENTSEN. Mr. Speaker, let me start out by congratulating the
committee for putting together this legislation and putting together
the conference report. This is a very good bill. I think it says a lot
about the Congress that it has been able to respond as quickly as it
has to the events of September 11 and the subsequent events of anthrax
that we felt right here on Capitol Hill.
Subsequent to September 11, I had the opportunity to meet with the
heads of a number of the institutions in the Texas Medical Center which
is in my congressional district and is the largest medical center in
the United States. In discussions with those individuals, I learned
that while we had the knowledge throughout the United States in our
various medical complexes to deal with the threat of bioterrorism, we
did not necessarily have the means to deploy that knowledge. We really
were not prepared to deal with it. And so a number of the institutions
followed the lead of the Committee on Energy and Commerce and others in
the Congress to try and address this and say that the Federal
Government and the taxpayers would make an investment in making sure
that we could deploy those medical assets the next time there is an
attack.
As some of the speakers said, this bill may not go far enough, and I
would concur with that; but it certainly is a very good start to begin
to address this situation, to make sure that not just in the Nation's
capital but throughout the United States that our local communities,
with their local health care facilities, will begin to put together the
plans to be able to deploy these assets to protect the American
populace.
{time} 1245
That is what we ought to be doing in this body to address that. So I
want to commend the Members, the chairman and ranking member of the
full committee and subcommittees that worked on this, and I urge my
colleagues to pass the legislation.
Mr. Speaker, I rise today in support of the conference report for
H.R. 3448, the Public Health Security and Bioterrorism Preparedness and
Response Act. In the wake of the September 11 terrorism attacks on the
United States, it is clear that we need to invest in our public health
infrastructure to ensure that we are prepared for future terrorism
attacks. As the representative for the Texas Medical Center, the
nation's largest medical center, I have learned that our nation's
hospitals are not adequately prepared for bioterrorism attacks and need
federal assistance in order to upgrade their facilities.
I am pleased that this conference report authorizes federal funding
of $1.6 billion in Fiscal Year 2003 for grants to states, local
governments, and public and private health care facilities to improve
planning and preparedness activities. Of this total, $520 million in
state grants will be made for the preparedness of hospitals, including
children's hospitals to enhance their capacity to deal with emergencies
such as bioterrorism attacks. I believe that all hospitals should be
eligible to receive this funding in order transform their emergency
department. This legislation also authorizes $300 million to upgrade
and expand the Centers for Disease Control and Prevention (CDC)
facilities. During the recent anthrax attacks, we learned that the CDC
does not have adequate staff and laboratories to conduct testings for
individual anthrax tests. This legislation will correct this
insufficiency and invest in our public health response. This measure
also authorizes funding of $1.1 billion to expand the supply of
vaccines, medicines, and supplies available to treat biological weapons
such as anthrax. This funding will also ensure that we have adequate
supply of smallpox vaccines and other antidotes for biological agents.
In order to protect public health, this legislation would also give
the Food and Drug Administration additional authority to detain and bar
food products. While we know that certain imported foods can kill
children, yet the FDA does not currently have the ability to bar those
who have knowingly imported these foods which have been adulterated or
misbranded. This conference report also authorizes the FDA to require
food importers to notify the FDA in advance of their arrival. This will
help the FDA to carefully monitor which foods are being imported into
the United States in order to protect public health. Finally, this bill
would require all facilities that manufacture, process, pack, or hold
food for consumption to register with the FDA. With registration, the
FDA will be able to quickly track food products and appropriately act
when any food products result in sickness or illness for our Nation's
population. This measure would also provide new resources to protect
our water supply. This conference report authorizes $160 million in
Fiscal Year 2002 and such sums as necessary for future years. Under
this bill, the 353
[[Page H2853]]
largest water systems which serve a total of 116 million people will be
required to conduct annual vulnerability assessments. The legislation
also requires those water systems which serve more than 3,300 persons
to prepare an emergency response plan. Both of these requirements will
encourage our water systems to carefully analyze their vulnerability to
biological attacks and to prepare when their water supply may have been
contaminated.
Finally, this legislation includes provisions to reauthorize the Food
and Drug Administration's prescription drug user fee program through
Fiscal Year 2007. This measure would authorize the collection of $1.2
billion in fees over five years in order to ensure that the FDA has
sufficient resources to review prescription drug applications. These
additional fees help the FDA to hire additional personnel who can
review prescription drugs and medical devices.
I urge my colleagues to support H.R. 3348, legislation that will
ensure that our Nation is better prepared when the next terrorism
attack comes. With recently warnings of potential terrorism attacks, I
believe that our public health infrastructure is well prepared.
Mr. TAUZIN. Mr. Speaker, I yield myself 1 minute to introduce the
next speaker.
Mr. Speaker, the gentleman I am about to introduce was not only one
of the conferees on this important legislation, but he and the
gentleman from Georgia (Mr. Linder) and I believe the gentlewoman from
California (Ms. Harman) were extraordinarily diligent in offering this
House a special bill to upgrade and enable the Centers for Disease
Control, which was woefully inadequate prior to the passage of this
bill today.
CDC is an incredibly valued institution in America. Not only does it
track and help respond to the spread of infectious diseases, but it is
going to be critical in the efforts to defend this country from
biological or other forms of attack.
The gentleman from Georgia (Mr. Chambliss), the gentleman from
Georgia (Mr. Linder) and the gentlewoman from California (Ms. Harman)
are to be congratulated for not only leading this effort, but ensuring
that this bill contains those important provisions to enable and
improve and to strengthen the quality of the work done by the CDC.
Mr. Speaker, I am pleased to yield 2 minutes to the gentleman from
Georgia (Mr. Chambliss).
(Mr. CHAMBLISS asked and was given permission to revise and extend
his remarks.)
Mr. CHAMBLISS. Mr. Speaker, as someone who spent several years
working on issues of terrorism and advocating better preparedness and
readiness to meet the unique challenges we face from terrorists who
want to harm Americans, I am very pleased with the final agreement on
this bill. It is clear that we continue to face very real threats from
sophisticated terrorists who would use dangerous biological agents in
their savage and relentless efforts to carry out acts of violence
against Americans.
We must do all we can to keep dangerous biological agents out of the
wrong hands. However, whether in response to a terrorist attack,
accident or natural outbreak of infectious disease, our public health
and disease surveillance system is not as robust and capable as it
needs to be to meet the demands which will be placed on it in a severe
public health emergency. We recognize that local officials and our
doctors, police, firefighters and local emergency responders will be on
the front lines of an attack, and we must make sure that they are
trained and ready to respond.
This bill will address many of these concerns. A critically important
provision taken from the bill authored by the gentleman from Georgia
(Mr. Linder), the gentlewoman from California (Ms. Harman) and myself
will provide $300 million per year and multi-year contracting authority
to the Centers for Disease Control to upgrade and modernize their old
and decaying facilities which are in desperate need of repair.
I am particularly pleased that we are taking concrete and far-
reaching steps to address the particular issue of agro-terrorism. I
have felt for a long time that our agriculture infrastructure is very
vulnerable to the threat of intentional damage and disease. As part of
this bill, we bolster the Department of Agriculture's ability to detect
animal and plant diseases and respond as needed to protect our food
supply and American agriculture. We expand inspection activities and
provide much-needed increases in agriculture biosecurity at colleges,
universities and laboratories, including funding for a biocontainment
laboratory at the University of Georgia.
Thanks to the strong leadership of the gentleman from Louisiana
(Chairman Tauzin), the gentleman from Michigan (Mr. Dingell), Senator
Frist and Senator Kennedy and their staffs, we worked in a bipartisan
way to craft a bill that will go a long way toward making our country
much better prepared to respond to biological attacks.
Mr. Speaker, I urge the passage of this bill.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentlewoman
from Texas (Ms. Jackson-Lee).
(Ms. JACKSON-LEE of Texas asked and was given permission to revise
and extend her remarks.)
Ms. JACKSON-LEE of Texas. Mr. Speaker, I thank the gentleman for
yielding me time, and I would like to thank the chairman of the
Committee on Energy and Commerce and the ranking member of the
Committee on Energy and Commerce along with the conferees for a report
that has taken us a very long way since September 11.
I served on the Homeland Security Task Force chaired by the gentleman
from New Jersey (Mr. Menendez), and we worked some hours after
September 11 and our focus was in many areas. But I want to raise 2
points that were extremely important to the work that I did on local
law enforcement.
We know the first responders were always very important to our
communities, but we saw them at work after September 11 in a light that
we had never seen before. I want to applaud the State and local
preparedness allocation of $1.6 billion in particular, but I do want to
emphasize the $520 million for State grants to enhance the preparedness
of hospitals, including children's hospitals, clinics, health centers
and primary care facilities for bioterrorism.
It was my emphasis in that committee to give the resources to our
local clinics, our public health systems, such as the Harris County
Health District in my community, which really would face the threat of
terrorism in our local communities.
Some days after September 11, I met with over 40 members of our
HAZMAT teams and those dealing with these issues around our Metroplex
area, and they are the ones that need the support. As we speak, the
City of Houston has a prepared plan to submit for 1 of these grants,
and I will be encouraging them and working with them for that
submission and for receiving such.
Finally, let me say as the ranking member on the INS Subcommittee on
Immigration and Claims of the Committee on Judiciary, issues dealing
with food entry on our borders is very important, and the provisions
dealing with detaining food, providing the FDA with the authority to
order detaining of food that may be suspicious, I applaud them for
that. The increased inspections, where the FDA can require food
importers to notify the FDA 30 days in advance of their arrival at the
port of entry, is very important.
Lastly, I would say the prohibition on port shopping is crucial. We
know that the Canadian border is one that we need to be concerned
about. I would only encourage in my conclusion, Mr. Speaker, that we
look to more technology at the border so we can do food x-ray
inspection or inspection of the food as it comes across, because that
certainly poses a very severe threat.
I ask my colleagues to support the conference report.
Mr. TAUZIN. Mr. Speaker, in addition to the great work done by the
Committee on Agriculture, the Committee on the Judiciary was a big
contributor to this bill.
I am pleased to yield 2 minutes to the gentleman from Texas (Mr.
Smith), the chairman of the Subcommittee on Crime, Terrorism and
Homeland Security of the Committee on the Judiciary.
Mr. SMITH of Texas. Mr. Speaker, first of all, I would like to thank
the chairman of the Committee on Energy and Commerce for yielding me
time and for his great work on this legislation.
Mr. Speaker, in the wake of the terrorist attacks of September 11 and
the subsequent anthrax-laced mail, bioterrorism has become a very real
threat
[[Page H2854]]
to the American people. The Bioterrorism Preparedness Act of 2002
addresses such threats by improving the ability of the United States to
respond to and prevent biological attacks.
This conference report requires coordination among agencies that
regulate biological agents and toxins that pose a threat to human
health. The Department of Health and Human Services, which has primary
responsibility for public health issues, and the Department of
Agriculture, which has primary responsibility for animal and plant
health, are required to develop a coordinated strategy.
An important provision of this conference bill focuses on enhancing
controls of dangerous biological agents and toxins by requiring
registration of all persons who possess, use or transfer them. The
legislation directs the Secretary of Health and Human Services and the
Secretary of Agriculture to develop specific security measures for
personnel and facilities that handle these dangerous substances. In
addition, the conference report provides criminal penalties for
possession of these agents without registration and for their transfer
to unregistered persons or facilities.
Mr. Speaker, these are very important additions to the laws already
put in place by the USA PATRIOT Act.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself 1\1/2\ minutes.
Mr. Speaker, I want to comment briefly on the Medicare provisions in
the bill. One or more of my colleagues has expressed concern about the
inclusion of some provisions in this legislation that are important. I
want to make sure my colleagues understand these measures do not in any
way adversely affect Medicare beneficiaries.
Several of us, the gentleman from Michigan (Mr. Dingell), the
gentleman from California (Mr. Waxman), the gentleman from New Jersey
(Mr. Pallone), none of us would have signed off on legislation that
would have done anything but that.
One of these provisions is critically important for Medicare
beneficiaries. Under current law, beneficiaries who choose to enroll in
a managed care plan become locked into that plan. They must wait until
the annual open enrollment program to switch plans or go into Medicare
fee for service.
This bill removes that restriction, delays it for 3 years. We want to
continue to delay it. The best we could do in the compromise was a 3-
year delay rather than a permanent removal, so that Medicare
beneficiaries can leave managed care, are not locked into that plan,
can leave any time during the year and not just in the annual open
enrollment period.
We also include in the language in the conference report provisions
to protect in terms of time, when the Medicare period was moved from
July to September. CMS has agreed we have language in the conference
report to make sure that is enough time for people to be able to
change.
So those provisions on Medicare are solid, they are bipartisanly
agreed to. Beneficiaries will benefit, not at all be hurt, but in fact
benefit by that language.
Mr. TAUZIN. Mr. Speaker, I yield myself 30 seconds simply to commend
the gentleman for his statement.
Mr. Speaker, those provisions were agreed upon in a bipartisan
fashion in the regulatory relief bill, which earlier passed this House,
and I believe are in the interests of the beneficiaries of the Medicare
system. I thank the gentleman for his similar conclusion. They were
signed off on by all the committees of jurisdiction as well.
Mr. Speaker, I am pleased to yield 1\1/2\ minutes to the gentleman
from Pennsylvania (Mr. Pitts) for a colloquy.
Mr. PITTS. Mr. Speaker, I rise also in support of the bioterrorism
conference report, and since PDUFA is included in this bill, I would
like to enter into a colloquy with the chairman.
Mr. Chairman, as you know, I am very interested in ensuring timely
access to plasma therapies for the thousands of people who rely on
these life-saving medicines. The plasma industry pays the fees
authorized under PDUFA, yet there are no performance goals associated
with plasma lot release, which must occur prior to these products being
released by the FDA. Longer lot release times mean that the therapies
do not get to patients in a timely manner.
I strongly believe that the FDA should work with the plasma industry
to assure greater predictability in lot release and to lessen the
amount of time required for lot release.
Mr. Speaker, I would like to ask the chairman to respond.
Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
Mr. PITTS. I yield to the gentleman from Louisiana.
Mr. TAUZIN. Mr. Speaker, first, let me acknowledge the hard work the
gentleman has already put forth on this issue. I agree with the
gentleman, frankly, and applaud his efforts.
Plasma lot release times have varied greatly over the last few years.
Predictability is important. I think the industry and FDA should sit
down and begin a dialogue which will lead to greater cooperation and
predictability in lot release, and I intend to help the gentleman make
sure that dialogue occurs.
Mr. PITTS. Mr. Speaker, reclaiming my time, I thank the gentleman
very much.
Mr. BROWN of Ohio. Mr. Speaker, I reserve my time.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 1 minute to the
gentleman from Oklahoma (Mr. Lucas), a member of the Committee on
Agriculture.
Mr. LUCAS of Oklahoma. Mr. Speaker, 8 months ago our perspective on
the potential threats to our borders changed forever as we saw the true
capacity of evil on our defenseless citizens. Three days ago we were
reminded that that threat was still very real when the Vice President,
Mr. Cheney, said the question of another terrorist attack was not if,
but when.
Today we in the House take an important step in preventing important
attacks by passing this conference committee report. In November of
last year I introduced legislation that addressed many of the issues
that had been included in title III of the conference report before us
today.
Included in both my bill and today's conference report are an
increased presence of animal, plant and food and safety inspectors at
the ports of entry. The APHIS and FSIS will develop strategies to
prevent future incidents where animal and plant diseases are used by
terrorists to attack U.S. citizens.
Mr. Speaker, I urge my colleagues to support this conference report.
I thank the chairman and ranking member for their diligent efforts.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman
from California (Mr. Schiff).
Mr. SCHIFF. Mr. Speaker, I thank the gentleman for yielding me time.
Mr. Speaker, I rise in support of the Public Health Security and
Bioterrorism Preparedness and Response Act conference report. It has
been nearly 8 months since the deadly anthrax attacks, and authorities
still have not determined who is responsible. However, it appears very
likely that the highly concentrated form of anthrax did not originate
from overseas, but rather may have come from an American laboratory.
In addition to unsecured anthrax, we have other challenges involving
national, State and local health care workers and first responders, to
make sure they are equipped with the tools they need to fight
bioterrorism threats, and we also have food security issues to
consider, as well as a potentially vulnerable water supply.
Today we are taking a major step forward in addressing some of these
issues. In particular I am pleased that the bill contains provisions
similar to those included in legislation that I introduced last fall
with Senator Feinstein.
Our bill, the Deadly Biological Control Act, will require that the
Department of Health and Human Services maintain and regularly update a
list of deadly biological agents, viruses and bacteria that poses
severe threat to public health and safety. It requires every laboratory
that possesses any of these select agents to be government-certified
after proving that they will be used strictly for legitimate research
purposes and that sufficient measures are in place to safely handle and
dispose of those agents while ensuring protection against unlawful
access.
{time} 1300
Finally, lab employees would have to register with the Department of
Health
[[Page H2855]]
and Human Services and pass through a criminal background check. These
provisions are critical because under current law, laboratories that
acquired anthrax and other deadly agents prior to 1997 were not
required to register with the government unless they were shipping the
agent to another lab, as a result of the thousands of laboratories
nationwide which stock deadly biological agents, viruses, and bacteria
without uniform security standards or proper Federal oversight. Under
these lax security conditions, a rogue employee or outside terrorist
group could easily gain access to some of the most dangerous pathogens
on Earth.
I applaud the leadership of the gentleman from Michigan (Mr. Dingell)
and the gentleman from Louisiana (Mr. Tauzin) as they work with the
Senate conferees to bring this bill to the floor, and I urge my
colleagues to support this important conference report.
Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the
distinguished gentlewoman from Maryland (Mrs. Morella).
Mrs. MORELLA. Mr. Speaker, I rise in strong support of the conference
report and for the Public Health Security and Bioterrorism Preparedness
and Response Act. I indeed thank the gentleman from Louisiana (Mr.
Tauzin), the chairman of the committee, and the gentleman from Michigan
(Mr. Dingell) for their fine work and for the members and the staff of
both committees. This is a terrific conference report, it is strong,
and it is bipartisan, and it is critically important to our Nation as
we continue to boost security in our preparedness against terrorism.
The conference report will improve the public health infrastructure
at the national, State, and local levels to address growing threats of
bioterrorism. The legislation provides additional resources to prepare
us for bioterrorist threats or other public health emergencies.
I am particularly pleased that this legislation will boost programs
and provide critical resources for many local communities who were on
the front lines in the hours and the days following September 11, and
the subsequent anthrax attacks. These brave men and women deserve our
fullest commitment.
I look to my own district in Montgomery County, Maryland. Our first
responders were there at the Pentagon on that terrible morning of
September 11, and the Federal scientists at the National Institutes of
Health and the Food and Drug Administration are working harder than
ever to produce new treatments and vaccines for anthrax, among other
bioterror agents.
The conference report we are considering today ensures emergency
readiness and demonstrates a significant Federal commitment to local
jurisdictions who ensure the safety and health of the American people.
In addition, the conference report improves protection of our water
supply and increases the protection of our Nation's food supply. The
Food and Drug Administration, headquartered in my district, will have
an increased number of food inspectors to ensure our food is safe from
bioterrorists.
Mr. Speaker, the conference report we are considering deserves our
fullest support.
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman
from Maryland (Mr. Wynn), a member of the Committee on Energy and
Commerce.
Mr. WYNN. Mr. Speaker, I rise in strong support of the conference
report to H.R. 3448, the Bioterrorism Preparedness Act.
Let me take a moment and congratulate and thank our committee
chairman, the gentleman from Louisiana (Mr. Tauzin), for his
outstanding work; as well as our own ranking member, the gentleman from
Michigan (Mr. Dingell), for his work; the subcommittee chairman, the
gentleman from Florida (Mr. Bilirakis); and my good friend and
subcommittee ranking member, the gentleman from Ohio (Mr. Brown). They
have done good work in bringing this bill to the floor in the true
spirit of bipartisanship.
I am particularly pleased because this bill provides $1.6 billion for
grants to States and local governments, the first responders of our
frontline of defense, for public and private health care facilities to
improve planning and preparedness activities. It will enhance
laboratory capacity, educating and training for health care personnel,
and develop new drugs, therapies and vaccines, all a very important
task for our homeland security.
This funding is particularly critical to upgrade our local health
infrastructure to respond to a bioterrorism attack. I represent
suburban communities just outside of Washington, D.C. After September
11, we realized how much we were on the front line. For instance, in my
district in Montgomery County, Maryland, we require much-needed
assistance to improve disease surveillance and also to train our local
personnel, as well as to restore and improve our hospital preparedness,
so this is very important to us.
The measure also provides $1.5 billion of funding to expand the
current stockpiles of medicines and vaccines such as smallpox. That is
what people are concerned about in the area of bioterrorism, and the
bill responds.
Finally, the bill provides $300 million in critically important
funding to upgrade and expand the Centers for Disease Control and
Prevention facilities. It will allow, again, the training of personnel,
particularly critical as we enter this new age; facilities improvement
for combating bioterrorism in terms of upgrading the security of our
labs and also, again, expanding disease surveillance.
Mr. Speaker, this is an excellent bill. Again I commend our
leadership on both sides of the aisle for putting it together, and I
urge my colleagues to support the conference report.
Mr. TAUZIN. Mr. Speaker, I reserve the balance of my time for
closing.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself the remainder of the
time.
Mr. Speaker, I thank the gentleman from Louisiana (Mr. Tauzin) and
the gentleman from Florida (Mr. Bilirakis) and the gentleman from
Michigan (Mr. Dingell) and the staffs of all of the Members that were
involved for their excellent work on this very complicated bill.
All of us are clearly happy with the legislation and disappointed
with the legislation. I would like to highlight again as we close in
the last couple of minutes a couple of highlights of that. I am
particularly happy with the antibiotic resistance language in this
bill. It is really the first time Congress, and I give credit to the
gentleman from Louisiana (Mr. Tauzin) and really everybody involved, it
is the first time Congress has addressed this issue as seriously as we
have on this. It is a serious problem, with drugs as common as
penicillin, a drug that we all know, now is not as effective an
antibiotic as it was 20 years ago. We are seeing a whole host of
antibiotics not as effective as they were. This bill is the first step.
What we have left undone is legislation that we will continue to come
to this committee on and hope to work with the gentleman from Louisiana
on where half the antibiotics in this country are used for
nonmedicinal, nontherapeutic purposes in animals, not to cure sick
animals, but to help animals grow faster and to help animals actually
not get disease because of the way we pack these animals together in
pens that are too small. We are going to need to make some changes
there, and I hope this Congress will seriously take that issue up.
I think on food safety, while we have done a reasonably good job on
this bill, I hope that we can look more seriously at country-of-origin
labeling and some other issues.
I am pleased with post-market surveillance of prescription drugs, as
we have pushed through, with PDUFA in speeding up, accelerating the
process of approval of prescription drugs, a very good thing to get
them on the market more quickly so that consumers can benefit from
them, patients can benefit from them. We also have done something in
this bill we had not done before, and that is fund post-market
surveillance so that when those drugs get on the market more quickly
than they have in the past, if there are problems, the FDA is looking
much more closely as these drugs are used in a huge part of the
population rather than just clinical trials so that we, in fact, can
detect much more quickly than before if there is damage done to people
with the vast increase in the use of these drugs, with direct consumer
advertising and all that.
This legislation also has good provisions with something called
DDMAC, which is Division of Drug Market Advertising and Communications
at FDA.
[[Page H2856]]
It is a review of marketing materials. As the drug companies, more and
more, are spending huge numbers of dollars marketing their drugs, I
think that will be a particularly positive direction.
I am disappointed, and I hope that we can move in a positive way on
the pediatric rule so that as we passed legislation last year on the
pediatric exclusivity, to give the drug companies 6 months more patent
time, if you will, an extension of their patent so that they would test
their drugs on children, test these prescription drugs on children
that, in fact, we will codify the pediatric rule at some point so that
drug testing will be done immediately on children as it is being done
on adults during the clinical trials.
So those are some things I hope we can look for. We have done a good
job on this bill with PDUFA; we have done a good job on this bill
overall with bioterrorism; we have done a good job with food safety and
antibiotic resistance. There is a lot more to do on antibiotic
resistance; there is a lot more to do with food safety; there is a lot
more to do with preserving safety and efficacy of prescription drugs on
the market as we get them on the market more quickly.
So I would close by expressing my gratitude to the conference
committee and by imploring the chairman of the Committee on Energy and
Commerce, the distinguished gentleman from Louisiana (Mr. Tauzin), so
that we can move forward on some of these other issues during the next
few months.
Mr. Speaker, I yield back the balance of my time.
Mr. TAUZIN. Mr. Speaker, I yield myself the remaining time.
Let me first thank the gentleman from Ohio (Mr. Brown) for his kind
comments and for the extraordinary work that he and other colleagues on
the other side of the aisle have provided us in producing, I think, an
excellent bill from conference.
Let me first clarify something. In debate earlier, I think I heard
the suggestion that the EPA would be required in the bill to review the
vulnerability assessments submitted to it under title IV. I want to be
very clear about this. Nothing in this conference report contains that
requirement. The report simply makes that discretionary with the EPA.
The reports are submitted to EPA, and they are not required to review
them. It is a discretionary matter with EPA.
Mr. Speaker, let me first make a point that I think is important.
This bill comes up at an extraordinary time in our Nation's history. It
comes up in a week when partisanship reared its ugly head as we
discussed issues involving 9-11 over the last several weeks. But I want
to make something very clear. This bill represents the best of
bipartisanship. This bill, shepherded through by the staff, by Reid
Stuntz on the Democratic side and Mr. Dave Marventano on our side and
the incredible work of the staffs on all three committees, the
Committee on Agriculture and the Committee on the Judiciary, has
produced a huge bipartisan response to the enemies of our country who
think they can threaten us with biological agents or threaten us with
attacks upon our food or water supplies and make this country more and
more vulnerable.
There was a time before 9-11 when we did not think these thoughts,
when we did not have to do what this bill requires. But 9-11 taught, I
think, all of us some lessons; and I think it also demonstrated
something to the world and to our enemies around the world, that this
country is full of heroes. There are heroes who work in our own forces
who are in Special Forces right now in Afghanistan and parts of the
world we may not even read about who are defending us right now against
al Qaeda and the folks around the world who would indeed threaten our
security here at home. There are heroes who work in much more quiet and
obscure places, in little hospitals, in the CDC, and they work at a
border station where they inspect food and drugs coming into this
country. They may be members of an ambulance team. They may be members
of a first response team. But those heroes in America who demonstrated
on 9-11 just how this country can respond when we need to are going to
be better armed today with $4.6 billion of new tools.
This is an incredibly important bill. It is a statement, bipartisan
statement here in America that we are ready to defend this country, and
we are ready to make sure our heroes, both abroad and at home, are
equipped with all of the tools they need to make us safer and more
secure.
Mr. TAUZIN. Mr. Speaker, when the Joint Statement of Managers was
filed last night, it inadvertently omitted some important language
concerning a Performance Goals Letter for the authorization of the
Prescription Drug User Fee Act (PDUFA).
Chairman Tauzin and Ranking Minority Member Dingell hereby submit the
following additional statement which they view as authoritative
legislative history on the provision in question.
Performance Goals Letter
Authorization of PDUFA is accompanied by a letter entitled
``PDUFA Reauthorization Performance Goals and Procedures.''
The goals letter is unique to PDUFA. It does not have force
of law, but nonetheless the Agency views it as a statement of
their obligations, and they issue a yearly report on their
performance in meeting the goals specified in the letter.
Title IX of the goals letter is entitled ``Independent
Consultants for Biotechnology Clinical Trial Protocols.''
Contained in this title, as negotiated by the agency, is a
paragraph ``D. Denial of Requests.'' As forwarded to the
Congress, this paragraph previously read: ``except in the
most unusual circumstances (for example, it is clearly
premature) FDA will honor the request and engage the services
of an indep4endent consultant, of FDA's choosing, as soon as
practicable. If the Agency denies the request, it will
provide a written rationale to the requester within 14 days
of receipt.'' Upon agreement of the Conferees, this paragraph
shall now read ``D. Denial of Requests: FDA will grant the
request unless the Agency determines that engagement of an
expert consultant would not serve a useful purpose (for
example, it is clearly premature). FDA will engage the
services of an independent consultant, of FDA's choosing, as
soon as practicable. If the Agency denies the request, it
will provide a written rationale to the requester within 14
days of receipt.''
The requirement of the Agency to provide a written
rationale for the refusal to engage an independent consultant
is not intended to burden the Agency but rather to assist the
applicant in understanding the reason for Agency action.
The goals letter also, for the first time, includes a title
on ``pre- and Peri-NDA/BLA Risk Management Plan Activities''
(Title VIII). The Managers view this title as a strong
addition to the PDUFA regimen. Under this title, user fee
monies will be available for postmarket surveillance for up
to three years for drug and biological products. The Managers
strongly support this Title, and upon agreement of the
Managers, the title will now include the following additional
language at the end Section D of Title VIII: ``FDA will
allocate $76,319,879 in user fees over 5 years to the
activities covered in this section. FDA will track the
specific amounts of user fees spent on these activities and
will include in its annual report to Congress an accounting
of this spending.''
W.J. ``Billy'' Tauzin,
Chairman.
Mr. BALDACCI. Mr. Speaker, I am pleased that we will be passing
legislation today to authorize vital funding for our state and local
public health systems. Recognizing the difficulties facing our state
and local governments and health facilities following the unprecedented
attacks on our country, it's clear that we must greatly expand the
resources of our health systems.
Mr. Speaker, immediately following the first Anthrax attacks, I met
with public health officials from my State, and with representatives of
community health provider systems. What I learned from this discussion
is that our local and state health infrastructure and information
systems is woefully unprepared to deal with the level of biomedical,
chemical and radiological threats for which we clearly now must be
prepared.
I am very concerned about the speed of which funds have been
distributed to our state and local governments in order to update their
health systems to deal with future attacks.
Today with passage of the Bioterrorism bill we will be making a
commitment to our states, local governments and health facilities. We
will provide significant assistance to their efforts to protect the
health of our citizens. Funds will be translated into improvements in
preparedness planning, surveillance, lab and hospital capacity and
information and communication technology specific to meet the needs of
our state and local health systems.
States will receive for bioterror-related activities $1.6 billion in
grants in fiscal year 2003, and local hospitals will receive $520 to
prepare for medical emergencies, with additional funds authorized at
such sums as necessary for fiscal year 2004 through fiscal year 2006.
These funds are on top of those already appropriated and distributed
for the current fiscal year of over $1 billion.
I would add that as much as I appreciate these specific funds for
bioterror threats, I believe other important issues facing our state
[[Page H2857]]
and local governments should be addressed. In particular, I support
forward funding of fiscal year 2003 monies the President has identified
for First Responders in our districts and states. Many of those charged
in our state and local governments for maintaining public safety are
frustrated with the lack of funding for first responder needs. To date,
no funds for local first responders has been sent to our states. I hope
that significant funds for First Responders become available for
distribution as soon as possible. While the Supplemental legislation
which we will consider later today does provide $175 million for first
responders, much more is needed to cover costs our local and state
governments have incurred and will soon incur to put necessary safety
and preparedness plans in place.
Mr. Speaker, I am pleased to support today's bioterrorism conference
report and urge my colleagues to support this measure to set aside
vital funds to our state and local governments and hospitals.
Mr. GREEN of Texas. Mr. Speaker, I rise today in support of this
Bioterrorism Conference Report.
I commend our chairman and ranking member, Mr. Tauzin and Mr.
Dingell, for their hard work in developing this consensus legislation.
This bill represents the kind of common-sense, worthwhile policy that
can be produced when the two parties work together.
This bill includes a number of important provisions that will go a
long way to improve our nation's ability to prevent and respond to a
bioterrorist attack. With the formula grants in this bill, states will
be able to better develop their public health infrastructure, so that
they can recognize and contain bioterrist outbreaks.
The legislation creates a stockpile of drugs and vaccines, so we are
able to quickly treat individuals who are affected. And it improves
food safety inspection at our nation's borders to protect our food
supply and makes sure that our water supply is not vulnerable to
terrorist attack.
This legislation also reauthorizes and improves upon the Prescription
Drug User Fee Act, which ensures that life-saving medications make it
through the FDA approval process as quickly as possible.
Once again, I thank my colleagues for their hard work on this
legislation.
Mr. SHAYS. Mr. Speaker, last Thursday, three men were arrested in
Easton, Connecticut after being seen videotaping a water reservoir and
filtration plant. The good news: A vigilant employee alerted local
police. City and state emergency response teams were mobilized, the FBI
was brought in, and the water was tested and found to be safe. The bad
news: Before being seen, those three men got past security fences and
``No Trespassing'' signs, and could have destroyed or contaminated
facilities supplying drinking water to 238,000 people in southeastern
Connecticut.
It appears to have been an innocent mistake, a misguided desire to
capture Connecticut's beautiful scenery from the wrong vantage point.
But the incident demonstrates the vulnerability of critical water
systems to biological terrorism.
This conference report begins to address protection of water supplies
by directing updated threat assessments, vulnerability assessments and
incorporation of both into current emergency response plans.
The current frustratingly vague string of alerts about potential
terrorist acts cannot obscure one hard truth evident even before
September 11: It is not a question of whether but only when, where and
at what magnitude the United States will be attacked using biological,
chemical, radiological or even nuclear weapons. To meet that threat,
pharmaceutical stockpiles need to be augmented, disease surveillance
should be strengthened, and public health capacities far better
integrated into emergency response plans.
This bill is costly. More will be needed in the years to come. But
the costs of an uncoordinated, ineffective response to bioterrorism
will be paid in human lives, civil disorder, loss of civil liberties
and economic disruption that could undermine both national security and
national sovereignty.
If there is a ray of hope in the threat of bioterrorism it lies in
this irony: improving the public health infrastructure against a man-
made biological assault today better prepares us to face natural
disease outbreaks every day. Just as biotechnologies can be used to
produce both life-saving therapies and deadly pathogens, publics health
capabilities are likewise ``dual use,'' enhancing our protection
against smallpox attack by a terrorist and an influenza pandemic
produced by Mother Nature.
Mr. SHIMKUS. Mr. Speaker, I submit for the Record the following on
Public Health Security and Bioterrorism Response Act conference.
food authorities of bioterrorism bill
Title III of the bioterrorism bill responds to legislative
proposals presented to Congress by the Department of Health
and Human Services. We worked closely with Secretary Thompson
and personnel of the Food and Drug Administration to craft
the most extensive expansion of the food related enforcement
authorities in the history of the Federal Food, Drug, and
Cosmetic Act (FFDCA). New authorities provide for expanded
records access and maintenance, administrative detention of
foods, registration of food facilities and several other
provisions that are especially focused on assuring effective
oversight of food imports. These new authorities strike a
balance by adding significantly to the already strong
enforcement authorities of the FDA, while assuring that the
authorities will be used only for their intended purposes. I
believe that my colleagues will be pleased with how this
balance was struck to protect the American consumer and
permit a robust competitive food system to provide consumers
a wide variety of affordable foods.
administrative detention: section 303 of the title
Amendment to Section 304 of the FFDCA provides the
Secretary with limited authority to detain administratively
an article of food where the FDA has ``credible evidence or
information indicating that such article presents a threat of
serious adverse health consequences or death.'' ``Credible
evidence or information'' requires that the FDA have specific
evidence or information that it believes to be reliable and
probative. The ``serious adverse health consequences''
standard, which is used consistently in Title III of this
Act, relates to the situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death. This standard corresponds to existing FDA guidance
under section 7.3 of Title 21 of the Code of Federal
Regulations.
A detention order must be approved by a senior FDA official
(district director for the district in which the food to be
detained is located or a more senior official). In general,
the Secretary should expedite the processing of seizure or
injunction actions with regard to food that has been
detained. The Secretary is required to provide by regulation
for the expedition of such actions in the case of perishable
food, such as fresh produce and seafood.
Once a detention order is issued, the Secretary must insure
that the detained article of food is kept in a secure
facility under conditions commercially appropriate for the
food to ensure that the safety and quality of the food is
maintained during the detention.
Any person who would be entitled to claim the article of
food if the food were seized may appeal a detention order to
the Secretary. If an appeal is filed, the Secretary must
provide an opportunity for an informal hearing which would be
conducted in accordance with the procedures set forth in Part
16 of Title 21 of the Code of Federal Regulations. The
Secretary has five days to confirm, modify or terminate the
detention order; failure of the Secretary to provide for an
informal hearing or to act on the appeal within five days of
an appeal automatically terminates the detention order. The
Secretary may not thereafter re-institute the terminated
detention order.
This section also permits the Secretary to request that the
Secretary of Treasury hold food offered for import at a port
of entry for a period not to exceed 24 hours if the FDA is
unable to inspect, examine, or investigate the food when it
is offered for import and the Secretary has ``credible
evidence or information'' indicating that the article of food
``presents a threat of serious adverse health consequences or
death to humans or animals.'' The purpose of the temporary
hold is to permit the FDA to inspect, examine or investigate
the article of food. Amendments to Section 801 of the FFDCA
provide for prior notice of shipments of imported food;
consequently, the temporary hold authority should not be used
routinely.
DEBARMENT: SECTION 304 OF THE TITLE
Amendment to Section 306 of the FFDCA would provide broad
authority for debarment of persons from food importation so
that FDA may protect against persons who might willfully sell
harmful foods. Debarment may be based on a felony conviction
relating to the importation of food into the United States or
upon a person engaging in a pattern of importing adulterated
food that presents a threat of serious adverse health
consequences. The conferees intend for this authority to be
exercised reservedly to assure that only ``bad actors'' are
the subject of debarment actions. The courts have defined a
pattern of proscribed conduct as three or more separate
instances of a similar character. Thus, three violative lots
of a common shipment would be of a similar character, but not
constitute a pattern because they were effectively shipped at
the same time and afforded no notice to the importer. The
events that make up the pattern must be of a sufficiently
similar nature and time sequence to provide the innocent
importer effective notice and opportunity to undertake
precautionary procedures to guard against reoccurrence. The
managers intend for this debarment authority ordinarily to be
exercised based on felony convictions. In the absence of a
felony conviction, permissive debarment authority should be
exercised only pending felony prosecution.
REGISTRATION: SECTION 305 OF THE TITLE
A new Section 415 of the FFDCA would provide require that
the Secretary implement an expansive program of registration
of facilities engaged in manufacture, processing,
[[Page H2858]]
packing or holding food for human consumption to assist
the Secretary in promptly contacting management of
concerned food facilities in the event of a threat to food
safety. The registration is to include information
regarding the name and address of the facility, as well as
all trade names under which the facility conducts
business. Also, if the effectiveness of the registration
system would be significantly enhanced without undue
burden, the Secretary may require by guidance that the
general food category of products of the facility be
specified. Within 18 months of enactment the Secretary is
required to promulgate implementing regulations, which
shall specify compliance timeframes and other
requirements. The conferees fully expect FDA to complete
the rulemaking in the 18 months provided.
The bill would require the Secretary to promptly notify
each registrant of their registration number. The conferees
intend for the Secretary to provide for electronic data
submission and use of an electronic database to maintain a
current listing of registered facilities. The listing of
registered facilities is to be held strictly confidential.
Since failure to register would be a violation of the Federal
Food, Drug, and Cosmetic Act, prompt issuance of registration
numbers under this system is imperative.
The bill would authorize the Secretary to broadly impose
the registration requirement to domestic facilities engaged
in processing or distributing food for human consumption as
the Secretary deems necessary. However, the registration
requirement would not authorize registration of farming
facilities (including facilities attendant to harvesting of
food crops), restaurants or other retail food establishments
(including facilities attendant to their operations, which
are under the same ownership or management) or most fishing
vessels. In addition, the Secretary would be authorized to
require registration of a foreign facility, but only if food
from such facility is exported to the United States without
further processing or packaging outside the U.S. If an
article of food that is offered for import is from a foreign
facility for which registration has not been submitted, the
article would be held at the port of entry until registration
is submitted.
The conferees intend for the Secretary to exercise his
discretion in the development and implementation of
registration regulations to ensure that registration
requirements are neither burdensome nor disruptive of the
smooth flow of commerce.
maintenance and inspection of records: section 306 of the title
A new Section 414 of the FFDCA would authorize FDA to have
access to and to copy certain records in the possession of
persons involved in the production and distribution of food.
Access to records would occur only if the Secretary has a
reasonable belief that an article of food is adulterated and
presents a threat of serious adverse health consequences. The
``reasonable belief'' standard is intended to make clear that
the Secretary must have evidence or information in hand that
would cause a reasonable person to conclude that the food is
both adulterated and presents a threat of serious adverse
health consequences. Once the standard is met, the Secretary
would have authority to gain access to and copy only those
records needed to assist the Secretary in determining whether
the food is adulterated and presents a threat of serious
adverse health consequences.
Records that would be subject to inspection under this
authority relate to the manufacture, processing, packing,
distribution, receipt, holding, or importation of the food
being investigated, regardless of the format or location of
the record. This records access would not extend to the most
commercially sensitive or confidential records of the record
keeper, including recipes (including formulation and
preparation or processing techniques), financial data,
pricing data, personnel data, research data, or sales data
(other than shipment data regarding sales). Clearly, the
authority would not permit access to any records regarding
employees, research or customers (other than shipment data),
nor would it permit access to information such as
correspondence or marketing plans.
This new records access authority is responsive to a
request of the Department so that investigation may be made
of possible threats to the public health, but strictly
limited to avoid potential abuse of confidential business
information. The managers intend for limitations on records
access to be strictly observed. A determination that there is
reasonable belief that a food is adulterated and presents a
threat of serious adverse health consequences should be made
under the direct supervision of senior officials of the FDA.
In addition, the Secretary would be required to take
appropriate measures, presumably through rulemaking and
assuredly with the benefit of comments from record keepers,
to prevent the unauthorized disclosure of trade secret or
confidential information obtained by the Secretary. The
managers envision procedures whereby no agency personnel will
have access to records without a specific need for such
access, possession of all copies of records will be strictly
controlled, and detailed records regarding all handling and
access to these records will be kept. Shortcomings in such
procedures or lapses in adherence to them should be viewed as
a presumption of unlawful release of the records. Such record
protections are to be in place prior to FDA exercising new
records access authority.
A conforming amendment to Section 704 of the FFDCA is also
included in this section. This conforming amendment would
provide the Secretary no greater access to records (either in
circumstances during which records access is permitted, the
types of records that may be accessed, or protections
afforded records that are obtained) than would be authorized
under new Section 414.
prior notice: section 307 of the title
Amendment to Section 801 of the FFDCA would require that
the Secretary promulgate regulations for submission of notice
prior to the importation of any food to enable the Secretary
to provide for inspection of food imports at ports of entry.
The conferees intend for the Secretary to expeditiously
promulgate the required regulations so that efficiency of
food import inspections may be improved. The Secretary would
be required to consult with the Secretary of the Treasury in
promulgation of prior notice regulations to assure that
smooth coordination is achieved between FDA and U.S. Customs.
The managers intended for the Secretary to exercise
discretion to ensure that neither the requirements of the
notice nor the timing of prior notice be more burdensome
than necessary to provide for the availability of food
import inspectional personnel. The Secretary should
exercise discretion in promulgating and implementing these
rules to assure that prior notice requirements never
become a barrier to the smooth flow of commerce. If an
article of food were offered for import without providing
the required prior notice, the article of food would be
held at the port of entry until the Secretary has
determined that notice is complete, but it would not be
held longer than the unelapsed period of prior notice
unless there is other basis for doing so. If the Secretary
fails to promulgate prior notice regulations within 18
months of enactment, the bill specifies the information to
be provided in the notice and that notice must be provided
no less than 8 hours, and no more than 5 days, prior to
offering the article of food for import. The conferees
fully expect FDA to complete the rulemaking within the 18
months provided.
marking refused articles: section 308 of the title
Another amendment to Section 801 of the FFDCA would
authorize the Secretary to require that the outermost
container of a shipment of certain foods that have been
refused admission into the U.S. be marked ``UNITED STATES:
REFUSED ENTRY''. The purpose of such a marking would be to
alert inspectional personnel at the port of entry of a second
attempt to import the refused food shipment. Accordingly, the
conferees intend for this authority to be exercised in cases
where there is reason to believe that the shipment may be
offered for import at another U.S. port of entry. The
conferees do not intend for this authority to be used to
require markings that are unlikely to be observed at import
inspection or that may inhibit the lawful marketing of a
product in another country. The Secretary is expected to
consult with the Secretary of Treasury regarding development
of regulations to implement this provision.
Mr. COMBEST. Mr. Speaker, I would first like to commend Chairman
Tauzin, ranking Member Dingell and all of the other conferees and their
staffs for their hard work on this important legislation. This
conference report represents a concerted effort by the Congress, the
Bush Administration and numerous constituent groups coming together to
tackle, head-on the threat of bioterrorism in the United States.
The attacks of September 11, and the subsequent mailing of Anthrax
contaminated mail to the capitol, media outlets, and the devastating
release of this deadly organism in postal facilities, led all Americans
to reconsider the fundamentals. Members of Congress naturally turned to
exploring ways that the public can be protected from potential
terrorist attacks.
As Chairman of the Agriculture committee, my responsibility has been
to evaluate and safeguard our nation's food supply. The Congress,
working with the Executive branch, has a responsibility to farmers,
ranchers, processors, retailers, and consumers to ensure appropriate
steps are being taken to maintain confidence in our food supply.
Fortunately, the U.S. Department of Agriculture has been in the
biosecurity business for a long time. The Animal Plant Health
Inspection Service (APHIS) has its origins in the 19th century. The
Food Safety Inspection Service (FSIS) started operations at the
beginning of the 20th century.
Likewise, other sectors of our economy have recognized the fact that
they have had to make wholesale changes in how they function. In some
cases, organizations are in the process of being completely retooled or
even created out of whole cloth. Thankfully, with regards to the
Department of Agriculture, we already have broad legal authorities,
plentiful resources, and trained personnel already in place to address
the threats of the 21st century.
Nearly 5,000 APHIS employees securing our border from the importation
of animal and plant diseases and 7,600 FSIS inspectors in every meat
and poultry plant in America are
[[Page H2859]]
already working to protect our food production system. Obviously, the
events of September 11 have caused these and other agencies of USDA to
increase their vigilance, but we are very fortunate to have them. Not
unlike our firefighters and police, they do a difficult job every day;
a job we appreciate even more during these troubled times.
With this legislation, additional resources will be authorized for
the USDA to modernize its Agricultural Research Service laboratory
facilities. Likewise, funding is authorized for the USDA to provide
grants to agricultural colleges and universities to review their
security needs. These grants, coupled with security upgrade grant
authority included as part of the recently passed Farm Security and
Rural Investment Act of 2002 will strengthen our biosecurity and food
safety research capabilities for years to come.
Likewise, authority is granted to expand on USDA's biosecurity
research programs, both in the Agricultural Research Service, and those
programs involving colleges and universities throughout United States.
This conference report strengthens USDA's regulatory efforts with
regard to food safety, and animal and plant health. Specifically, the
conference report recognizes the inadequacy of current USDA authorities
with regard to the regulation of biological agents and toxins that
present a severe threat to plant or animal health, and the products of
plants and animals. Based on this recognition, the conference report
adopts provisions that would grant nearly identical authorities to the
USDA as those granted to the Department of Health and Human Services
for the regulation of possession, use or transfer of listed biological
agents and toxins.
Mr. Speaker, I would close by once again thanking all of the
conferees who have worked on this legislation. Likewise, I would like
to thank the employees of the Department of Agriculture who worked very
closely with my staff in hammering out the details of this legislation.
Specifically, I would like to mention the outstanding efforts of Dr.
Curt Mann and Deb Atwood from the Office of the Secretary, Molly
Phillips from the Office of Congressional Relations, Pilar Ruttenberg
and Sheila Novak from the Office of General Counsel, Courtney Billet,
Dr. Andrea Morgan and Mr. Chuck Schwalbe from the Animal and Plant
Health Inspection Service, and Christy Slamowitz from the Office of the
Inspector General.
Mr. DINGELL. Mr. Speaker, when the Joint Statement of Managers was
filed last night, it inadvertently omitted some important language
concerning a Performance Goals Letter for the authorization of the
Prescription Drug User Fee Act (PDUFA).
Chairman Tauzin and Ranking Minority Member Dingell hereby submit the
following additional statement which they view as authoritative
legislative history on the provision in question.
Performance Goals Letter
Authorization of PDUFA is accompanied by a letter entitled
``PDUFA Reauthorization Performance Goals and Procedures.''
The goals letter is unique to PDUFA. It does not have force
of law, but nonetheless the Agency views it as a statement of
their obligations, and they issue a yearly report on their
performance in meeting the goals specified in the letter.
Title IX of the goals letter is entitled ``Independent
Consultants for Biotechnology Clinical Trial Protocols.''
Contained in this title, as negotiated by the agency, is a
paragraph ``D. Denial of Requests.'' As forwarded to the
Congress, this paragraph previously read: ``Except in the
most unusual circumstances (for example, it is clearly
premature) FDA will honor the request and engage the services
of an independent consultant, of FDA's choosing, as soon as
practicable. If the Agency denies the request, it will
provide a written rationale to the requester within 14 days
of receipt.'' Upon agreement of the Conferees, this paragraph
shall now read ``D. Denial of Requests: FDA will grant the
request unless the Agency determines that engagement of an
expert consultant would not serve a useful purpose (for
example, it is clearly premature). FDA will engage the
services of an independent consultant, of FDA's choosing, as
soon as practicable. If the Agency denies the request, it
will provide a written rationale to the requester within 14
days of receipt.''
The requirement of the Agency to provide a written
rationale for the refusal to engage an independent consultant
is not intended to burden the Agency but rather to assist the
applicant in understanding the reason for Agency action.
The goals letter also, for the first time, includes a title
on ``Pre- and Peri-NDA/BLA Risk Management Plan Activities''
(Title VIII). The Managers view this title as a strong
addition to the PDUFA regimen. Under this title, user fee
monies will be available for postmarket surveillance for up
to three years for drug and biological products. The Managers
strongly support this Title, and upon agreement of the
Managers, the title will not include the following additional
language at the end Section D of Title VIII: ``FDA will
allocate $76,319,879 in user fees over 5 years to the
activities covered in this section. FDA will track the
specific amounts of user fees spent on these activities and
will include in its annual report to Congress an accounting
of this spending.''
John D. Dingell,
Ranking Member.
Mr. Speaker, I commend this conference report to the House, and I
yield back the balance of my time.
The SPEAKER pro tempore (Mr. LaHood). Without objection, the previous
question is ordered.
There was no objection.
The SPEAKER pro tempore. The question is on the conference report.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Mr. TAUZIN. Mr. Speaker, I object to the vote on the ground that a
quorum is not present and make the point of order that a quorum is not
present.
The SPEAKER pro tempore. Evidently a quorum is not present.
The Sergeant at Arms will notify absent Members.
Pursuant to clause 8 of rule XX, this 15-minute vote on agreeing to
the conference report will be followed by two 5-minute votes on motions
to suspend the rules that were debated yesterday.
The vote was taken by electronic device, and there were--yeas 425,
nays 1, not voting 8, as follows:
[Roll No. 189]
YEAS--425
Abercrombie
Ackerman
Aderholt
Akin
Allen
Andrews
Armey
Baca
Bachus
Baird
Baker
Baldacci
Baldwin
Ballenger
Barcia
Barr
Barrett
Bartlett
Barton
Bass
Becerra
Bentsen
Bereuter
Berkley
Berman
Berry
Biggert
Bilirakis
Bishop
Blagojevich
Blumenauer
Blunt
Boehlert
Boehner
Bonilla
Bonior
Bono
Boozman
Borski
Boswell
Boucher
Boyd
Brady (PA)
Brady (TX)
Brown (FL)
Brown (OH)
Brown (SC)
Bryant
Burr
Buyer
Callahan
Calvert
Camp
Cannon
Cantor
Capito
Capps
Capuano
Cardin
Carson (IN)
Carson (OK)
Castle
Chabot
Chambliss
Clay
Clayton
Clement
Clyburn
Coble
Collins
Combest
Condit
Conyers
Costello
Cox
Coyne
Cramer
Crane
Crenshaw
Crowley
Cubin
Culberson
Cummings
Cunningham
Davis (CA)
Davis (FL)
Davis (IL)
Davis, Jo Ann
Davis, Tom
Deal
DeFazio
DeGette
Delahunt
DeLauro
DeLay
DeMint
Diaz-Balart
Dicks
Dingell
Doggett
Dooley
Doolittle
Doyle
Dreier
Duncan
Dunn
Edwards
Ehlers
Ehrlich
Engel
English
Eshoo
Etheridge
Evans
Everett
Farr
Fattah
Ferguson
Filner
Flake
Fletcher
Foley
Forbes
Ford
Fossella
Frank
Frelinghuysen
Frost
Gallegly
Ganske
Gekas
Gephardt
Gibbons
Gilchrest
Gillmor
Gilman
Gonzalez
Goode
Goodlatte
Gordon
Goss
Graham
Granger
Graves
Green (TX)
Green (WI)
Greenwood
Grucci
Gutierrez
Gutknecht
Hall (OH)
Hall (TX)
Hansen
Harman
Hart
Hastings (FL)
Hastings (WA)
Hayes
Hayworth
Hefley
Herger
Hill
Hilleary
Hilliard
Hinchey
Hinojosa
Hobson
Hoeffel
Hoekstra
Holden
Holt
Honda
Hooley
Horn
Hostettler
Houghton
Hoyer
Hulshof
Hunter
Hyde
Inslee
Isakson
Israel
Issa
Istook
Jackson (IL)
Jackson-Lee (TX)
Jefferson
Jenkins
John
Johnson (CT)
Johnson (IL)
Johnson, E. B.
Johnson, Sam
Jones (NC)
Jones (OH)
Kanjorski
Kaptur
Keller
Kelly
Kennedy (MN)
Kennedy (RI)
Kerns
Kildee
Kilpatrick
Kind (WI)
King (NY)
Kingston
Kirk
Kleczka
Knollenberg
Kolbe
Kucinich
LaFalce
LaHood
Lampson
Langevin
Lantos
Larsen (WA)
Larson (CT)
Latham
LaTourette
Leach
Lee
Levin
Lewis (CA)
Lewis (GA)
Lewis (KY)
Linder
Lipinski
LoBiondo
Lofgren
Lowey
Lucas (KY)
Lucas (OK)
Luther
Lynch
Maloney (CT)
Maloney (NY)
Manzullo
Markey
Matheson
Matsui
McCarthy (MO)
McCarthy (NY)
McCollum
McCrery
McDermott
McGovern
McHugh
McInnis
McIntyre
McKeon
McKinney
McNulty
Meehan
Meek (FL)
Meeks (NY)
Menendez
Mica
Millender-McDonald
Miller, Dan
Miller, Gary
Miller, George
Miller, Jeff
Mink
Mollohan
Moore
Moran (KS)
Moran (VA)
Morella
Murtha
Myrick
Nadler
Napolitano
Neal
Nethercutt
Ney
Northup
Norwood
Nussle
Oberstar
Obey
Olver
Ortiz
Osborne
Ose
Otter
Owens
Oxley
Pallone
Pascrell
Pastor
Payne
Pelosi
Pence
Peterson (MN)
Peterson (PA)
Petri
Phelps
Pickering
Pitts
Platts
Pombo
Pomeroy
Portman
Price (NC)
[[Page H2860]]
Pryce (OH)
Putnam
Quinn
Radanovich
Rahall
Ramstad
Rangel
Regula
Rehberg
Reyes
Reynolds
Rivers
Rodriguez
Roemer
Rogers (KY)
Rogers (MI)
Rohrabacher
Ros-Lehtinen
Ross
Rothman
Roukema
Roybal-Allard
Royce
Rush
Ryan (WI)
Ryun (KS)
Sabo
Sanchez
Sanders
Sandlin
Sawyer
Saxton
Schaffer
Schakowsky
Schiff
Schrock
Scott
Sensenbrenner
Serrano
Sessions
Shadegg
Shaw
Shays
Sherman
Sherwood
Shimkus
Shows
Shuster
Simmons
Simpson
Skeen
Skelton
Slaughter
Smith (MI)
Smith (NJ)
Smith (TX)
Smith (WA)
Snyder
Solis
Souder
Spratt
Stark
Stearns
Stenholm
Strickland
Stump
Stupak
Sullivan
Sununu
Sweeney
Tancredo
Tanner
Tauscher
Tauzin
Taylor (MS)
Taylor (NC)
Terry
Thomas
Thompson (CA)
Thompson (MS)
Thornberry
Thune
Thurman
Tiahrt
Tiberi
Tierney
Toomey
Towns
Turner
Udall (CO)
Udall (NM)
Upton
Velazquez
Visclosky
Vitter
Walden
Walsh
Wamp
Waters
Watkins (OK)
Watson (CA)
Watt (NC)
Waxman
Weiner
Weldon (FL)
Weldon (PA)
Weller
Wexler
Whitfield
Wicker
Wilson (NM)
Wilson (SC)
Wolf
Woolsey
Wu
Wynn
Young (AK)
Young (FL)
NAYS--1
Paul
NOT VOTING--8
Burton
Cooksey
Deutsch
Emerson
Mascara
Riley
Traficant
Watts (OK)
{time} 1335
So the conference report was agreed to.
The result of the vote was announced as above recorded.
A motion to reconsider was laid upon the table.
Stated for:
Mr. Speaker, on rollcall No. 189 I was unavoidably detained and
unable to record my vote. Had I been able, I would have voted ``yea.''
____________________