[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

[[Page H2847]]

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

[[Page H2848]]

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
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[[Page H2860]]


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                                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.''

                          ____________________