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Therefore the consequences of such restrictions and regulations have further complicated the case, the research activities have been either shunned or go unreported to avoid any confrontation with the investigation agencies, 'the climate of fear created by the Butler case is even threatening the ability of the United States government to detect bioterrorist activity, the labs in one state are no longer reporting routine incidents of animals poisoned with RICIN, a deadly toxin found in castor beans, for fear of federal investigation'. Stanley Falkow, a respected researcher at Stanford University in California, in his letter to the former attorney-general of the United States revealed that, 'Trying to meet the unwarranted burden of what the government considers 'bio-safety' is simply not coincident with the practice of sound, creative scientific research'. The government introduced a policy which highlighted the need for tight control over the biologists 'with access to dangerous pathogens', in this regard Bioterrorism Preparedness and Response Act was promulgated, which imposed severe regulations on 'select agents, a list of 82 viruses, bacteria and toxins', which can be possibly used as bio-weapons (Jenny, 2004).
However, the American government has been successful in the identification of the 'agents responsible for many significant diseases that affect people, livestock or plants, including foot and mouth disease and the BSE prion that causes mad cow disease, even botulinum toxin is on the list, though the medical version, botox, is exempt from the regulations' (Jenny, 2004).
The American government has been able to evolve such policy in which it has tried to identify and shortlist the names of the relevant biologists who have interface with such chemical agents, the government has introduced a regulation as per which the biologists and relevant staff professionals have to register with the government, and have to submit their 'finger prints on record, get security clearances, and have their labs inspected, extensive controls have been placed on the movement of microbes and researchers, and all samples of select agents must be strictly accounted for or destroyed' (Jacqueline, 2006).
Previously there was a defined procedure for the transportation of the particular microbes, but after the implementation of the regulation the non-compliance of the regulation has been regarded as a crime. The scientific community of the country has appreciated such regulations aimed at tighter control over the chemicals and its utilization. The President of American Society of Microbiology has appreciated such regulations, and has vowed to follow it in spirit, 'common sense as well as government regulations dictate that the days of carrying vials of dangerous pathogens in our pockets are gone, as are those of leaving cultures of anthrax in open laboratories, as scientists we must honor a pact with the public to protect public health and defend against bioterrorism'. The organization along with leading journals such as Nature and Science has 'announced a voluntary self-censorship code that required crucial details that could be exploited by bioterrorists to be removed from scientific papers'. However the regulations have been condemned and opposed by certain departments, mainly because they are against the implementation of the procedural requirements, 'the Centers for Disease Control in Atlanta must now give permission to work with human pathogens, while the U.S. Department of Agriculture manages livestock diseases, this ought to allow diseases such as anthrax that affect both people and animals to be dealt with by either agency' (Jenny, 2004). The critics have complained that on instances the researchers do not have any access to the paper work even after the clearance is granted.
The rules have been considered as worst and inconsistent by some of the critics, a part of the regulation has stated that 'the regulations states that clinical labs that grow new cultures of select agents must destroy them within seven days', however on different instances it has been revealed that the labs have to secure permission prior to the destruction of cultures, which usually takes more than seven days. Therefore the scientists have been of the opinion that the compliance is impossible, 'every single lab involved in select agents has violated the regulations somehow; the investigation can penetrate and can observe the scientists of compliance whenever it chooses, the implications for government control of what scientists can do or say is, in the words of one, McCarthy-esque; even when the rules are clear, complying with them can be prohibitively expensive'. It was observed that in one of the state university, the university had to hire more than five full-time police, and has to appoint an extra secretary for three moderately sized labs. The state universities which do not have sufficient budget are left with no other option but to give-up their research of the listed agents.
The restrictions have been so severe that 'one researcher, afraid to be quoted, had to drop a proposal for work on ricin because it required a collaborator with particular equipment', and it is unlikely that any of the researcher will 'select agent without millions of dollars of pre-paid government money. The concerns have been expressed by the sponsors as well, 'potential partners do not want to risk criminal liability if they accidentally break any rules' (Jay, 2001). According to the regulations, all the research have to necessarily meet the deadlines, in case of failure the researchers have to destroy all the samples of the selected agents, such measures are almost impossible for the labs, where there are 'thousands of samples, and such collections are important for diagnosis, drug and vaccine testing, and for tracing outbreaks' However, such policy requires revision, because it was one of the old collection which helped the investigator in the identification of the strain used. According to one of the prominent researchers, after the imposition of the regulations al the select agents have been destroyed by the clinical labs in the country, therefore all the evidences have depleted, which is expected to hinder the investigation trails, when required.
However, the regulations have failed to settle some of the discrepancies, 'the disease, which can kill people and animals, is considered a prime bio-weapon candidate, but it is also endemic in many countries in the Americas and USAMRIID is working on a vaccine' (Jay, 2001).
The government has introduced an extensive government background check, which is fundamental. The check is essential else researchers have been excluded from their labs; the process have been condemned by the scientific community, therefore 'partly because of initial understaffing, the Federal Bureau of Investigation has not yet approved many staff'. The regulation is applicable on 'government scientists who already have high-level security clearances'. The Congress and Federal agencies are committed towards increase of 'regulations on chemicals, biological materials and related equipment for law enforcement and anti-terrorism purposes, rather than only for the traditional personal safety purposes, and there is an increase in the scope and type of laws and regulations governing transfer of biological materials and related equipment'. It is believed that the imposition of such restrictions will influence the academic research on chemicals and biological, 'as the life sciences are among the fastest growing areas of academic research'.
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