Bioterrorism and Food Safety
It directs the Secretary to periodically evaluate new technology to improve the ability of public health officials to conduct public health surveillance activities relating to bioterrorism or other public health emergency. It directs the DHHS, in consultation with the Attorney General and the Secretary of Defense, to provide assistance for security to facilities or people involved in countermeasures for bioterrorism and public health emergencies.
It directs the President to make potassium iodide tablets available to state and local governments through the national stockpile to provide protection for people living near a nuclear power plant, and requests that the National Academy of Sciences conduct a study to determine the most effective and safe way to distribute and administer potassium iodide tablets on a mass scale.
Subtitle C makes funds available for national security with respect to bioterrorism and other public health emergencies. Subtitle D affords flexibility regarding procedures in emergency situations. It provides extensions for certain reporting deadlines during a public health emergency and expands the authority of the Secretary, in consultation with the Surgeon General to specify communicable diseases that are subject to individual detention orders.
It amends title XI of the Social Security Act to add provisions with the purpose of ensuring that during an emergency, sufficient health care items and services are available to meet the needs of individuals on welfare, and health care providers furnishing such items and services in good faith, but that are unable to comply with one or more specified requirements may be reimbursed for such items and services and exempted from sanctions for noncompliance.
It amends the Robert T.
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Stafford Disaster Relief and Emergency Assistance Act to require information to be efficiently distributed to the public. The Secretary of Energy and the Administrator of the National Nuclear Security Administration is to expand research relevant to rapid detection and identification of pathogens likely to be used in a bioterrorism attack, and the Secretary, acting through the Director of the National Institute for Occupational Safety and Health , is to expand research on the health and safety of workers who are at risk for bioterrorism threats.
The Secretary of Veterans Affairs is to enhance the readiness of VA medical centers to protect patients and staff from chemical or biological attack or to respond to an attack. The Community Access to Emergency Defibrillation Act of directs the Secretary to award grants to States, political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs.
Authorizes appropriations. Title II deals with the security of dangerous biological agents and toxins used in research and development. Subtitle A amends the Public Health Service Act to enhance control of certain biological agents and toxins select agents. DHHS is to establish and maintain a list of agents that may pose a threat to public health and safety, provide regulation of transfers, provide for enforcement of standards for their possession and use, require registration of their possession, use, and transfer, and creates security requirements for people possessing select agents commensurate with the risk the agent poses to public health and safety, and authorizes DHHS to inspect for compliance with regulations.
All people in possession of select agents are to notify DHHS of possession. It authorizes exemptions for clinical or diagnostic laboratories and other institutions who possess select agents that are contained in specimens for diagnosis, verification, or proficiency testing, provided that the identification of such agents is reported to DHHS and other authorities, and such agents or toxins are transferred or destroyed in a safe manner set forth by regulation.
It authorizes exemptions for products that contain select agents and are cleared, unless DHHS determines that applying additional regulation to a specific product is necessary. It authorizes exemptions for an investigational product that contains a select agent when the product is being used in an investigation authorized under any federal act and the DHHS determines that applying additional regulation to such product is not necessary.source link
The Bioterrorism Act | U.S. Customs and Border Protection
The Agricultural Bioterrorism Protection Act of directs the Secretary of Agriculture to establish and maintain a list of select agents that the Secretary determines has the potential to pose a threat to animal or plant health. Regulations should be established for transfers, registration and maintenance of a database of listed toxins, and security of persons possessing select agents. It requires information on registered persons to be submitted to the attorney general to determine if they are within any restricted categories.
It requires prompt notification of the Secretary and law enforcement agencies of the theft or loss of listed agents and toxins.
As in Subtitle A, there are exemptions for clinical and diagnostic laboratories, products, investigational use, agricultural emergencies, and public health emergencies. It sets forth rules governing disclosure of information, penalties for violators, and reporting requirements. This states that the Secretary of Agriculture and the Secretary of Health and Human Services are to coordinate activities regarding overlapping agents and toxins. It amends federal criminal code provisions concerning possession of listed biological agents and toxins to provide that whoever knowingly transfers a select agent to a person they believe is not registered, or knowingly possesses a select agent for which a person has not obtained the required registration shall be fined, or imprisoned for not more than five years, or both.
Title III details the methods of protection of the nation's food supply against contamination or other threats. The President's Council on Food Safety, with the Secretary of Transportation, the Secretary of the Treasury, other relevant federal agencies, the food industry, and scientific organizations, develop a communication and education strategy with respect to bioterrorism threats to the food supply. It amends the FFDCA to direct the DHHS to give high priority to increasing the number of inspections to enable the inspection of imported food with the greatest priority given to inspections to detect the intentional adulteration of food, to give high priority to making improvements to the information management systems of the FDA for information related to imported food, to improve cooperation with other regulatory agencies that share responsibility for food safety, and to provide for research into the development of methods to test food to rapidly detect adulteration.
It permits an employee of the FDA to detain any food that is found during an inspection, if the employee has information that it presents a threat of serious adverse health consequences or death, but only if the Secretary or an official designated by the Secretary approves the order.
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It requires that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the US be registered with the Secretary, and allows for the debarment of importers with a history of repeated or serious food import violations. Permits the Secretary, if the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious health consequences or death to humans or animals, to have access to and copy all records that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat.
It requires the Secretary, if they have information that a shipment of imported food presents a threat of serious adverse health consequences or death to humans or animals, to provide notice regarding such threat to the appropriate States. It requires food importers to give the Secretary prior notice of the importation of any food for the purpose of enabling the food to be inspected. It authorizes the Secretary to commission employees of other federal departments or agencies, pursuant to a memorandum of understanding between the Secretary and the head of the other department or agency to conduct examinations and inspections for the Secretary under the FFDCA.
It amends the FFDCA to mandate electronic annual registration of foreign manufacturers and importers of drug and device products into United States. It mandates a chain of custody for those entities that seek to import components of drugs, devices, food additives, color additives, or dietary supplements for further processing and export, and requires certificates of analysis for components containing any chemical substance or biological substance intended for export. It authorizes the Secretary of Agriculture to utilize existing authorities to give high priority to expanding the capacity of the Animal and Plant Health Inspection Service to conduct inspections and allows for automated record keeping.
It authorizes the Secretary to utilize existing authorities to give high priority to expanding the capacity of the Food Safety Inspection Service to conduct inspections, and authorizes appropriations for enabling the Agricultural Research Service to upgrade buildings and modernize existing facilities. It provides grants to universities with programs in food and agricultural sciences to review security standards and practices at their facilities in order to protect against bioterrorism. It authorizes the Secretary to use existing research programs to protect the food supply of the United States by conducting and supporting research specified bioterrorism agricultural research and development activities.
Title IV amends the Safe Drinking Water Act to require community water systems serving a population of more than 3, to conduct an assessment of the vulnerability of its system to a terrorist attack, to certify and submit a written copy of the assessment, and to prepare an emergency response plan. Keep sensitive ingredients locked and have specific personnel identified and trained to handle them properly.
Fill ports for ingredients stored in external silos or tanks e. Have the ability to trace specific ingredient lots to finished product lots.
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These precautions apply to direct product contact packaging as well as to ingredients. Does your facility have a well for processing and clean-up water? Evaluate the security of the well systems. Consider testing for water potability more frequently, depending on the water source; e. Look for signs of sabotage to equipment, missing, broken or unprotected glass or indication of tampering with ingredients and packaging. Make sure that protective equipment e. Report any unusual activity to a manager, supervisor or appropriate authorities.
Account for all keys to the facility or restricted areas held by supervisory employees. In the event of a threat or real product tampering there must be a plan to address both the immediate issues as well as near term and long term issues. Terrorist actions can result in potential harm to plant employees, lost productivity, loss of customer confidence or lost business.
There are very good consultant companies that can help you prepare an effective plan; however, listed below are some examples of steps that you can take to help you pull through a crisis period. Test the effectiveness annually, at minimum. Develop a relationship with local print media, radio or television personnel so that they know about the company and the measures that you take to produce safe, quality products. As a nation we will recover from the tragedy of September 11 and our ideals of freedom and democracy will withstand evil terrorism.
Our political and military leaders will develop their plans to battle terrorism on an international front to prevent further catastrophe.
Safe Food: Bacteria, biotechnology, and bioterrorism
The American people have shown tremendous resilience in the face of adversity and a willingness to restore our damaged cities, our wounded economy and our fragile confidence. As food processors, we must do our part to assure that confidence in our products is never an issue. We must be prepared to prevent terrorists from striking our businesses; we must protect our common assets, valued customers and consumers. Michael M. He is primarily responsible for the development and implementation of food safety and quality programs for the company He has been involved in the food industry for more than 24 years with experience in poultry, processed meat, spice and coatings and frozen foods.
U.S. Finalizes Food Bioterrorism Rule