Biotechnology Research in an Age of Terrorism (2004) / Chapter Skim
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2. The Evolving Regulatory Environment for Life Sciences Research in the 21st Century
2. The Evolving Regulatory Environment for Life Sciences Research in the 21st Century
Pages 41-78
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From page 41... ...
. Research on human gene therapy is a special case, with both NIH and the Food and Drug Administration (FDA)
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From page 42... ...
. The NIH Guidelines described four levels of combinations of laboratory practices, containment equipment, and facility safeguards that were thought to be appropriate for the safe use and physical containment of rDNA molecules in research.
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It took the United States three years to ratify the 1972 Biological Weapons Convention (BWC) and 17 years for the United States Congress to pass legislation making the provisions of the BWC binding on all Americans.4 Not much changed until 1996 when, with the passage of the Antiterrorism and Effective Death Penalty Act, new regulatory controls were enacted swiftly regarding transfers of dangerous pathogens.5 Less than a year following the terrorist attacks on September 11, 2001 and subsequent anthrax mailings, two major pieces of legislation were passed by Congress and signed into law "The Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of October 2001"6 (hereinafter, the PATRIOT Act)
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From page 44... ...
The security provisions in the Bioterrorism Response Act are radically transforming the life sciences research environment in the United States from one that is basically open to one that excludes, based upon criteria stipulated in the PATRIOT Act, certain individuals from access to and research on certain listed agents. The FBI provisions, which went into force without public notice and comment rulemaking, prescribe the collection of pertinent background information on individuals; who may access, use, receive or transfer select agents, and the release and disclosure of that information to other entities as described in Section IV in the FBI Information Form (FD-961~.~ These provisions have raised concerns that qualified individuals may be discouraged from conducting biomedical and agricultural research of value to the United States because of the apparent infringement of these rules on individual liberties under the Fourth Amendment.
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From page 45... ...
The Guidelines are designed to address the risks to public health and the environment associated with exposure to either rDNA molecules or organisms or viruses containing such materials. The NIH Guidelines are applicable to all rDNA research within or outside the United States or its territories where the research is conducted at an institution that receives any support for the research from the NIH, including research performed directly by NIH.
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From page 46... ...
Adherence to the NIH Guidelines is mandatory and important because they stipulate biosafety and containment measures for rDNA research. Furthermore, they delineate critical ethical principles and outline key safety reporting requirements for human gene transfer research.
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has become responsible for ensuring that all rDNA research conducted at or sponsored by that institution is conducted in compliance with the NIH Guidelines. The RAC is, however, still responsible for advising the NIH director on actions such as: (1)
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All institutions subject to the NIH Guidelines are required to establish and register an IBC for the review of rDNA research. The IBC is designed to provide a quasi-independent review of rDNA work done at an institution.
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PHYSICAL AND BIOLOGICAL CONTAINMENT STRATEGIES FOR NIH-FUNDED rDNA RESEARCH ACTIVITIES Regulated experiments must be carried out in accordance with physical and biological containment levels; the degree of containment is based upon the degree of potential hazard. Physical containment requires practices, equipment, and facility safeguards that lessen the chances that a recombinant organism might escape.
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The containment conditions or stipulation requirements for such experiments must be recommended by the RAC and set by NIH at the time of approval. Containment conditions for experiments involving the introduction of rDNA into restricted agents are set on a case-by-case basis following NIH OBA review.
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. warmng signs 'Sharps' precautions Biosafety manual defining any needed waste decontamination or medical surveillance 1- pollcles BSL-2 practice plus: -Controlled access Decontamination of lab clothing before laundering -Baseline serum BSL-3 practices plus :-Clothing change before entering -Shower on exit -All material decontaminated on exit from facility None required Class I or II BSCs or other physical containment devices used for all manipulations of agents that cause splashes or aerosols of infectious materials; PPEs: laboratory coats; gloves; face protection as needed Class I or II BCSs or other physical containment devices used for all manipulations of agents; PPEs protective lab clothing; gloves; respiratory protection is needed All procedures conducted in Class III BSCs or Class I or II BSCs in combination with full-body, air-supplied, positive pressure personnel suit Open bench top sink required BSL-1 plus: Autoclave available BSL-2 plus: Physical separation from access corridors Self-closing, double door access -Exhausted air not recirculated Negative airflow into laboratory BSL-3 plus: Separate building or isolated zone Dedicated supply/exhaust, vacuum, and decon systems Other requirements outlined in the text iFrom the CDC/NIH Biosafety Guidelines: Biosafety in Microbiological and Biomedical Laboratories.
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The OHS Freedom of Information Officer informally determines whether the records have to be released; if so, they are returned to the submitting company.23 REGULATION OF MICROBIAL AGENTS (LISTED AGENTS AND TOXINS) The Antiterrorism and Effective Death Penalty Act of 1996 required the Secretary of HHS to establish and enforce safety procedures for the transfer of listed biological agents (select agents)
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An expanded list of pathogens and toxins went into effect on February 11, 2003. Agricultural plant and animal pathogens are now also included; the other changes reflect taxonomic changes and a few reassessments of what constitutes the most dangerous biothreat agents.25 The organisms and toxins covered by these regulations are also presented in Table 2-2.26 The PATRIOT Act makes it a criminal offense for any person to knowingly possess any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by prophylactic, protective, bona fide research, or other peaceful purpose.27 In addition, the new law prohibits transfer or possession of a listed biological agent or toxin by a "restricted person."28 Title II, Enhanced Controls of Dangerous Biological Agents and Toxins, of the Bioterrorism Response Act substantially broadens the regulatory obligations for laboratories working with select agents.29 The Secretary of HHS has the authority to establish and enforce safety procedures,30 including: (1)
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Tick-borne encephalitis complex viruses Variola major virus (smallpox virus) Venezuelan equine encephalitis virus Viruses causing hantavirus pulmonary syndrome Yellow fever virus Human and Animal Health Agents: Bacteria: Bacillus anthracis Brucella abortus Brucella melitensis Brucella suds Burkholderia mallet Burkholderia pseudomallei Clostridium botulinum Clostridium perfringens epsilon toxin Francisella tularensis Viruses: Nipah virus Eastern equine encephalitis v~rus Hendra virus Rift Valley fever virus Venezuelan equine encephalitis virus
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b 2003 USDA(Possession) C Exemptions: Vaccine strains of viral agents Qunin virus strain candid #1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D)
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b 2003 USDA(Possession) C Rickettsiae: Coxiella burnetii Rickettsia prowazekii Rickettsia rickettsii Fungi: Coccidioides immitis Rickettsiae: Coxiella burnetii Rickettsia prowazekii Rickettsia rickettsii Fungi: Coccidioides immitis Rickettsiae: Coxiella burnetii Fungi: Coccidioides immitis Animal Agents and Toxins: African horse sickness virus African swine fever virus Akabane virus Avian influenza virus (highly pathogenic)
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or natural ecosystems is made by the PI and the IBC, in consultation with scientists knowledgeable about plant diseases, crops, and ecosystems in the geographic area of the research.33 These regulations impose additional shipping and handling requirements on laboratory facilities that transfer or receive select agents capable of causing substantial harm to human health. They are designed to ensure that select agents are not shipped to parties who are not equipped to handle them properly or who lack proper authorization for their requests.
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."39 Registered facilities must limit access to listed biological agents and toxins only to those determined by the registered facility to have a legitimate need to handle or use select agents,40 and the secretary must be notified if a listed agent is lost, stolen, or released outside a biocontainment area of a facility.4~ IMPORTATION AND INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS The importation or subsequent receipt of human pathogens and vectors of human disease is controlled by the Public Health Service Foreign Quarantine Regulations (42 CFR Part 71.156~.42 Packages containing human pathogens or vectors originating in foreign locations must have an importation permit issued by the CDC. The importer is legally responsible for ensuring that the foreign personnel package, label, and ship the infectious materials according to the Interstate Shipment of Etiological
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The permit application requires the importer to provide characterization information for the material, a description of the objectives of the intended use, and a designation of the biosafety level of the laboratory where the work will occur. The CDC is also responsible for regulating the interstate shipment of indigenous human pathogens, diagnostic specimens, and biologic products.
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Since lanuary 2002 the Visas Condor security checks and the Technology Alert List reviews have required explicit approval from Washington for each applicant. In the past, at least the Alert List review process permitted consular officers to issue visas if they had not received a negative report from Washington within a certain number of days, but that is no
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From page 61... ...
The new Student and Exchange Visitor Information System (SEVIS) is an electronic System aimed at keeping better track of foreign students once they have received visas to study in the United States.50 The Bureau of Citizenship and Immigration Services (formerly the Immigration and Naturalization Service, which was incorporated into the Department of Homeland Security)
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IPASS is a response to an October 2001 Presidential Decision Directive, "Combating Terrorism Through Immigration Policies," which directed federal agencies to develop student immigration policies through which the country "prohibits certain students from receiving education and training in sensitive areas." The White House's Office of Science and Technology Policy (OSTP) has been working with the White House's Homeland Security Council and others to develop and implement IPASS, although at the time of this report the Executive Order to create IPASS had not yet been signed.
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It also offers examples from the regulatory systems of two other countries with advanced biotechnology research capabilities: the United Kingdom and lapan. The Committee's charge did not extend to a comprehensive review of the international regulatory environment, but the
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Controls Over Access to and Transfers of Dangerous Pathogens As discussed above, smallpox was declared to be eradicated by the WHO at the annual meeting of the World Health Assembly in May 1980. This led to the greatest international control over access to dangerous pathogens an international agreement implemented by the WHO to restrict the repository of smallpox virus cultures to two designated facilities, one in the United States and one in Russia.
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who is supplying and receiving pathogens. The European Union is the only regional organization to regulate the shipment of pathogens.65 The Situation in the United Kingdom In light of the September llth terrorist attacks in the United States, the focus has shifted from safety requirements in the laboratory toward greater scrutiny of dangerous substances and increasing the difficulty in gaining access to areas where such agents are stored and used.
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A constable who has entered any premises may search the premises, building, or site; require any person who appears to the constable to be in charge of the premises, building, or site to facilitate any such inspection; and require any such person to answer any question. If research establishments do not meet personnel or security requirements, access to dangerous pathogens and toxins could be withdrawn.
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The Organization for the Prohibition of Chemical Weapons oversees implementation of the exceptionally detailed Chemical Weapons Convention. Nothing comparable exists with regard
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In the United States, the PATRIOT Act and the Bioterrorism Response Act already establish the statutory and regulatory basis for protecting biological materials from inadvertent misuse. Once fully implemented, the mandated registration for possession of select agents, designation of restricted individuals who may not possess select agents, and a regulatory system for the physical security of the most dangerous pathogens within the United States will provide a useful accounting of domestic laboratories engaged in legitimate research and some reduction in the risk of pathogens acquired from designated facilities falling into the hands of terrorists.
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THE EVOLVING REGULATORY ENVIRONMENT FOR LIFE SCIENCES 69 to a systematic, generally applicable, means for the United States to respond to the challenges posed by research in the life sciences employing advanced biotechnology methods. Nor do they address the issues surrounding how to "manage" the knowledge and technologies produced through these research activities.
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"Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA Patriot Act) Act of 2001," Public Law 107-56, October 26.
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9Ibid. in In the loins Explanatory Statement of the Committee of Conference, the Managers stated that the primary goals of the new provisions in the Law are to "ensure the prompt reporting to the Federal government of possession of select agents (including by those who were in possession prior to April 15, 1997, the effective date for reporting transfers of select agents)
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The secretary must establish and enforce safeguard and security measures to prevent access to listed biological agents and toxins for use in domestic or international terrorism or any other criminal purpose. 37 The law further provides comparable regulatory authorities to the Secretary of the Department of Agriculture regarding the possession, use, or transfer of listed biological agents and toxins that present a severe threat to plant or animal health or animal or
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From page 76... ...
. Facilities should promptly submit the names of such individuals to the Secretary of Health and Human Services and the Attorney General who shall promptly use criminal, immigration, national security, and other electronic databases available to the federal government to check if the individual is a "restricted person." 4i In the loins Explanatory Statement of the Conference Committee's report, the Managers stated that the primary goals of the new provisions in the law are to "ensure the prompt reporting to the Federal government of possession of select agents (including by those who were in possession prior to April 15, 1997, the effective date for reporting transfers of select agents)
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2002. "Strengthening the Biological and Toxin Weapons Convention Countering the Threat from Biological Weapons," April 29.
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69 Human Genetics Advisory Commission Second Annual Report.
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