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“CONFERENCE REPORT ON H.R. 3448, PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002” mentioning the U.S. Dept of Agriculture was published in the Extensions of Remarks section on pages E919-E921 on May 24, 2002.
The publication is reproduced in full below:
CONFERENCE REPORT ON H.R. 3448, PUBLIC HEALTH SECURITY AND BIOTERRORISM
PREPAREDNESS AND RESPONSE ACT OF 2002
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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 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.''
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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