[Congressional Record Volume 148, Number 69 (Friday, May 24, 2002)]
[Extensions of Remarks]
[Pages E919-E921]
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

                                 ______
                                 

                               speech of

                          HON. JOHN D. DINGELL

                              of michigan

                    in the house of representatives

                        Wednesday, May 22, 2002

  Mr. DINGELL. Mr. Speaker, I would like to provide a further 
explanation of various provisions of H.R. 3448, the Public Health 
Security and Bioterrorism Response Act of 2002.


                                Title I

  Title I of the Act addresses planning, preparation, prevention, and 
response to acts of bioterrorism and other public health emergencies. 
As such, many of the programs will have a dual use. They will benefit 
the fight against terrorism and at the same time support our basic 
public health infrastructure. The bill will provide needed resources 
needed by first responders such as hospitals, health care personnel, 
public health systems, and others. The basic structure for providing 
these resources is through grants to eligible entities.
  One grant program will provide funds to eligible entities including 
states, political subdivisions of states or consortia of two or more 
such subdivisions. Another grant program will provide resources to 
eligible entities consisting of hospitals, clinics, health centers, or 
primary care facilities and various combinations of states or political 
subdivisions of states. The conference agreement is a compromise 
between distinctly different approaches in the Senate and House bills, 
plus a need to coordinate with the Administration's existing grant 
programs so that resources that will flow to states and first 
responders in FY 2002 and FY 2003 are not delayed, diminished, or 
denied.
  In basic terms, the grants are based on a bioterrorism preparedness 
and response plan that is supposed to include public input and that 
include criteria for evaluation of the performance of entities that 
receive funds to assure that they meet benchmarks in the plan. In sum, 
the bill is designed to provide flexibility and accountability with 
respect to the use of funds.
  The Department of Health and Human Services (HHS) also has 
flexibility in designating priorities for use of grant funds. Currently 
the priority is on bioterrorism or acute outbreaks of infectious 
disease, then other public health threats and emergencies. The 
priorities provide accountability and the Secretary's ability to modify 
these priorities allows flexibility in matching scarce resources to 
needs that vary around the country.
  A hallmark of the agreement is its emphasis on planning and 
coordination among various federal agencies and in turn federal 
coordination with state of local entities. Another key feature 
throughout is the use of advisory committees and other means of 
utilizing public and private sector expertise.
  One of the most important federal agencies with responsibility for 
fighting bioterrorism is the Centers for Disease Control and Prevention 
(CDC). The agreement acknowledges CDC's essential role in defending 
against and combating public health threats. It will provide resources 
for secure and modern facilities, and expanded and improved 
capabilities related to bioterrorism and other public health 
emergencies.
  In addition to grants, the agreement authorizes a variety of specific 
activities. These include education of health care personnel with 
respect to recognition and identification of potential bioweapons, for 
care of victims, and to recognize the special needs of children and 
other vulnerable populations. The bill also authorizes resources for 
the purpose of education and training in any category of health 
professions for which there is a shortage that the Secretary determines 
should be alleviated in order to prepare or respond to bioterrorism and 
other public health emergencies.
  The bill also directs research on antimicrobial resistance and other 
issues with respect to priority pathogens. The bill provides for 
limited Medicare and Medicaid waivers in appropriate circumstances, 
basically when providers respond to an emergency.
  Another key feature of Title I is the Strategic National Stockpile. 
This consists of drugs, devices, vaccines, and other products the 
Secretary determines to be appropriate and practicable, taking into 
account other sources, to provide for the emergency health security of 
the United States. Specific reference to the needs of children and 
other vulnerable populations is included.
  The bill also accelerates research and approval of priority 
countermeasures, establishes a process for evaluation of new and 
emerging technologies regarding bioterrorist attack, and strengthens 
programs to address health issues associated with nuclear facilities.


                                Title II

  Title II of the Act addresses select agents or hazardous biomaterials 
and the rules applicable to person with access to them. This provision 
addresses an area of great concern by increasing accountability for the 
storage and use of deadly materials and with respect to who has access 
to them.
  Title II requires that all persons, including state and local 
governmental entities and universities, that have access to select 
agents and toxins, undergo a screening review to determine if they are 
restricted persons under the PATRIOT USA Act or are suspected of being 
a terrorist, being affiliated with a terrorist organization, or are a 
foreign agent of a country attempting to covertly obtain information.
  The screening process is not expected to encompass the complex 
investigation that would occur prior to issuance of a security 
clearance, but to be similar to the check for prospective gun owners in 
its use of electronic databases. It will be carried out by the 
Department of Justice and limited to using appropriate electronic 
databases available to the government for this purpose to determine if 
the persons or individuals being screened are

[[Page E920]]

listed in those databases. This would guarantee both a timely response 
so that research is not delayed and prevent the use of non-credible, 
nonsubstantiated information. The Conference Report states, however, 
that other databases or ``files'' may be used by the Attorney General 
``to clarify or confirm information obtained during the electronic 
database search.'' The Privacy Act establishes the requirement that 
agencies maintain records on individuals with ``such accuracy, 
relevance, timeliness, and completeness as is reasonably necessary to 
assure fairness: and to ``make reasonable efforts'' before the 
dissemination of information about individuals to assure that such 
records are accurate, complete, timely, and relevant for agency 
purposes.'' 5 U.S.C. 552a. It is not the purpose of this provision to 
permit the Attorney General to do extensive individual investigations 
or use non-credible, unsubstantiated information that may be contained 
in those other ``files'' to deny persons or individuals access to 
select agents.
  Title 11 requires the same screening for non-federal entities, 
including corporations, public and private universities, and all state 
and local entities, including public health departments, that may 
possess select agents. It is expected that both the Department of 
Health and Human Services and the Department of Agriculture will use 
common sense in determining the level of screening it will require for 
universities, drug manufacturers, or others to avoid unnecessary 
paperwork and delays.
  Title 11 also contains exemptions from disclosure under the Freedom 
of Information Act for the registration documents, the national 
database compiling the information in the database, and the location 
(including the name of the registrant) and identification of select 
agents if contained in inspection reports or notifications of theft, 
loss, and releases outside of the bio-containment area of a facility. 
The purpose of these provisions is to protect site-specific information 
about these agents from being publicly available. It is not expected, 
however, that federal agencies will use the exemption to keep 
information that has public health implications from relevant 
nonfederal parties and the public, particularly if it is already 
publicly known. For example, there has been extensive media attention 
to the possible use of anthrax from the U.S. Army's laboratory at Fort 
Dettrick, Maryland, in the attack last fall. It has been known for many 
years that anthrax spores were located at Fort Dettrick. It is also 
known that the remaining smallpox virus in the United States is held by 
the Centers for Disease Control and Prevention. Releases of select 
agents from these and other facilities may have significant public 
health implications. An alert public may be the best method by which 
exposure to a select agent can be determined. Responses should not be 
delayed by federal agencies interpreting these FOIA exemptions too 
broadly.


                               Title III

  Title III of the Act deals primarily with food safety, particularly 
with respect to imported food. The Act has increased the ability of 
authorities to obtain greater assurances that food that is shipped into 
this country does not become an instrumentality of terrorism due to 
tampering. Four provisions, in particular, warrant further comment.


                    Prior Notice of Food Importation

  Section 307 requires the Secretary of Health and Human Services to 
promulgate regulations that establish a period of time in which prior 
notice of food importations must be provided to HHS. This period of 
time cannot exceed five days and must be sufficient in length for the 
Secretary to receive, review, and appropriately respond to such 
notices. The Secretary may consider many different factors in 
establishing this period of time, however, the Secretary's 
responsibility to the American people, as mandated by Congress herein, 
to ``receive, review, and appropriately respond'' to these notices is 
absolute. Since the Secretary will be held accountable for the proper 
discharge of this important new responsibility, the rule should duly 
consider this obligation and establish an ample period of time under 
which that obligation can be discharged.


            ``Credible Evidence or Information Indicating''

  Throughout this subtitle, the ``credible evidence or information 
indicating'' standard is used for various purposes. This standard 
should be interpreted broadly. The use of the conjunction ``or'' 
indicates that either credible evidence, or alternatively, information 
is sufficient to satisfy this standard. Accordingly, the standard could 
be read as ``credible information or evidence indicating a threat''. 
Moreover, any credible evidence or information only has to 
``indicate,'' not prove, that a threat exists. For example, if upon 
investigation, examination or inspection, FDA only has information that 
indicates a shipment of food presents a threat of serious adverse 
health consequences, it may invoke its administrative detention 
authority. FDA is never required to have traditional ``credible 
evidence'' to trigger this standard.


                     Explanation of Temporary Hold

  Under this bill, the Secretary must possess credible evidence or 
information indicating that a specific shipment or article of food 
presents a serious health threat to exercise his full detention 
authority. The bill, however, establishes a broader, less stringent 
standard for the Secretary to exercise a more limited temporary hold 
authority. Under the temporary hold provision, the Secretary need only 
have credible evidence or information indicating that an article of 
food, not a specific article of food, presents a serious health threat. 
If, for example, the FDA is in possession of credible evidence or 
information indicating that a category of food or food from a certain 
geographical region presents such a threat, the Secretary may use this 
authority to temporarily hold shipments or articles of food (up to 24 
hours) based on that information. This will enable the Secretary to 
appropriately dispatch FDA resources to gather credible evidence or 
information (based upon FDA inspection, examination or investigation) 
about specific shipments or articles of food. Once FDA has such 
evidence or information, the Secretary may then detain any such 
shipments or articles of food under the detention authority (up to 30 
days). The temporary hold authority is intended to function as an 
investigative tool that enables FDA to use its detention authority more 
effectively. Accordingly, the circumstances under which temporary hold 
authority can be invoked are broader than those under which detention 
authority can be invoked.


                   Registration of Foreign Facilities

  Section 305 requires foreign facilities to register with the 
Secretary of Health and Human Services if they manufacture, process, 
pack, or hold food that is exported to the United States without 
further processing or packaging, The provision clarifies that the 
addition of labeling, or other similar activities of a de minimis 
nature, may not be considered to be ``further processing or packaging'' 
for purposes of this section. This language was included to ensure that 
all facilities from the point of exportation back to the true foreign 
processor or packer would be required to register. Many Conferees were 
concerned that activities conducted immediately prior to exportation 
could be considered processing or packaging, even if such activities 
did not alter or affect the food. If that occurred, then that facility 
would be the only foreign facility in the chain of custody to register. 
The ``other similar activities of a de minimis nature'' language was 
added to address these concerns.


                                Title IV

  Title IV adds a new Section 1433 to the Safe Drinking Water Act that 
requires community water systems to conduct and complete vulnerability 
assessments and prepare or revise emergency response plans. These new 
requirements become requirements of the Safe Drinking Water Act.
  The conference agreement requires that a written copy of the 
vulnerability assessment be submitted to the Administrator. This will 
ensure that the vulnerability assessments meet the requirements of 
Section 1433 and that EPA will have the necessary information to 
determine whether action needs to be taken using the authority of 
Section 1431 or other relevant authorities to ensure that significant 
vulnerabilities are addressed to protect the public.
  The conference agreement takes a number of measures to protect the 
copies of the vulnerability assessments submitted to the EPA from 
unauthorized disclosure. The Administrator, however, may use and 
disclose the assessment, or information derived therefrom, to any 
individual, whether a private citizen or government employee, as 
designated by the Administrator, for the purposes of Section 1445, to 
take any action under the authority of Section 1431 or for use in any 
administrative or judicial proceeding to impose a penalty for failure 
to comply with Section 1433.
  In addition, the Administrator is expected to review the 
vulnerability assessments when providing financial assistance for basic 
security enhancements or to address significant threats to public 
health and the supply of drinking water. The agency continues to have 
available and may use its inspection and enforcement authorities under 
the Safe Drinking Water Act with respect to community water systems.
  The bill also amends Section 1431 of the Safe Drinking Water Act to 
provide new authority to the Administrator to take actions to assure 
the safety of the public and protect supplies of drinking water in 
circumstances of a threatened or potential terrorist attack or other 
intentional act at a community water system.
  Administrator Whitman has informed the Congress by letter dated April 
22, 2002, that the EPA has already begun working with states and local 
utilities to assess the vulnerability of the Nation's public water 
systems to attack or other intentional acts. Further, the Administrator 
has stated that the new language amending Section 1431 ``provides EPA 
with adequate authority to respond in situations involving significant 
vulnerability.''

[[Page E921]]

  The term ``potential terrorist attack'' should be interpreted in the 
context of the President's announcements that the United States is 
engaged in a war against terrorism and faces ``continuing and immediate 
threats of further attacks.'' Senior government officials have 
repeatedly warned that critical infrastructure facilities should remain 
on a high state of alert due to the possibility of a terrorist attack. 
Critical infrastructure protection is an issue of importance to 
economic and national security. Presidential Decision Directive 63 
released in May 1998 identified water supply as one of the 12 areas 
critical to the functioning of the country.
  Where the Administrator receives information that critical community 
water system infrastructures, such as a utility pumping system or 
chemical storage tanks, are vulnerable to potential terrorist attack 
that may present an imminent and substantial endangerment, he or she 
may use the authority provided by Section 1431 to protect the health 
and safety of the public or prevent the disruption of drinking water 
supplies.


                                Title V

  The Conference was able to resolve all outstanding issues regarding 
the reauthorization of the Prescription Drug User Fee Act (PDUFA). 
Reauthorizing PDUFA at this time was necessary to prevent a possible 
exodus of doctors and other very experienced medical officers at the 
FDA in anticipation of layoffs that will now be avoided. The Office of 
Drug Safety, an FDA function long neglected, was given $76 million in 
new user fee monies and at least $10 million in new appropriated monies 
to monitor adverse events and post market studies associated with the 
expedited approval process for drugs and biologics. Also, for fast 
track drugs, doctors are to be notified if mandated post market studies 
are not completed in a timely manner.

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