Editing Biosafety (section)

====Agency guidance====

Many government agencies have made guidelines and recommendations in an effort to increase biosafety measures across laboratories in the United States.  Agencies involved in producing policies surrounding biosafety within a hospital, pharmacy or clinical research laboratory include: the CDC, [[FDA]], [[USDA]], [[United States Department of Health and Human Services|DHHS]], DoT, [[EPA]] and potentially other local organizations including public health departments.  The federal government does set some standards and recommendations for States to meet their standards, most of which fall under the [[Occupational Safety and Health Act (United States)|Occupational Safety and Health Act]] of 1970.<ref name="osha.gov">{{cite web|url=https://www.osha.gov/dcsp/osp/|title=Directorate of Cooperative and State Programs - State Plans|publisher=Occupational Safety and Health Administration|access-date=2016-11-15|archive-date=2016-11-09|archive-url=https://web.archive.org/web/20161109123212/https://www.osha.gov/dcsp/osp/|url-status=live}}</ref> but currently, there is no single federal regulating agency directly responsible for ensuring the safety of biohazardous handling, storage, identification, clean-up and disposal.  In addition to the CDC, the [[Environmental Protection Agency]] has some of the most accessible information on ecological impacts of biohazards, how to handle spills, reporting guidelines and proper disposal of agents dangerous to the environment.<ref>{{cite web|url=https://www.epa.gov/regulatory-information-topic/regulatory-information-topic-waste#hazardous|title=Regulatory Information by Topic: Waste|first=US|last=EPA, OEI, OIAA, IAD|date=10 November 2014|access-date=15 November 2016|archive-date=16 November 2016|archive-url=https://web.archive.org/web/20161116015120/https://www.epa.gov/regulatory-information-topic/regulatory-information-topic-waste#hazardous|url-status=live}}</ref> Many of these agencies have their own manuals and guidance documents relating to training and certain aspects of biosafety directly tied to their agency's scope, including transportation, storage and handling of blood borne pathogens (OSHA,<ref>{{Cite web |url=https://www.osha.gov/Publications/osha3186.pdf |title=Model Plans and Programs for the OSHA Bloodborne Pathogens and Hazard Communications Standards |year=2003 |publisher=Occupational Safety and Health Administration |access-date=2016-11-15 |archive-date=2016-12-20 |archive-url=https://web.archive.org/web/20161220232735/https://www.osha.gov/Publications/osha3186.pdf |url-status=live }}</ref> [[IATA]]).  The American Biological Safety Association (ABSA) has a list of such agencies and links to their websites,<ref>{{cite web|url=https://www.absa.org/resbslinks.html|title=ABSA - Biosafety Links|access-date=2016-11-15|archive-date=2016-11-16|archive-url=https://web.archive.org/web/20161116015150/https://www.absa.org/resbslinks.html|url-status=dead}}</ref> along with links to publications and guidance documents to assist in risk assessment, lab design and adherence to laboratory exposure control plans. Many of these agencies were members of the 2009 Task Force on BioSafety.<ref>{{cite web|url=http://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/taskforcemembership.aspx|title=BioSafety Task Force Membership - PHE|access-date=2016-11-15|archive-url=https://web.archive.org/web/20170103173822/https://www.phe.gov/Preparedness/legal/boards/biosafetytaskforce/Pages/taskforcemembership.aspx|archive-date=2017-01-03|url-status=dead}}</ref> There was also a formation of a [[Blue Ribbon Study Panel on Biodefense]], but this is more concerned with national defense programs and biosecurity.

Ultimately states and local governments, as well as private industry labs, are left to make the final determinants for their own biosafety programs, which vary widely in scope and enforcement across the United States.<ref>{{cite web|url=http://www.triumvirate.com/State-by-state-Biosafety-Regulations|title=State-by-state Biosafety Regulations - Resource Page|first=Triumvirate|last=Environmental|access-date=2016-11-15|archive-date=2016-11-16|archive-url=https://web.archive.org/web/20161116015156/http://www.triumvirate.com/State-by-state-Biosafety-Regulations|url-status=live}}</ref> Not all state programs address biosafety from all necessary perspectives, which should not just include personal safety, but also emphasize an full understanding among laboratory personnel of quality control and assurance, exposure potential impacts on the environment, and general public safety.<ref>{{Cite web |url=https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf |title=Laboratory Safety Guidance |year=2011 |publisher=Occupational Safety and Health Administration |access-date=2016-11-15 |archive-date=2019-12-15 |archive-url=https://web.archive.org/web/20191215174945/https://www.osha.gov/Publications/laboratory/OSHA3404laboratory-safety-guidance.pdf |url-status=dead }}</ref>

[[Toby Ord]] puts into question whether the current international conventions regarding biotechnology research and development regulation, and self-regulation by biotechnology companies and the scientific community are adequate.<ref>{{Cite news|last=Ord|first=Toby|url=https://www.theguardian.com/science/2020/mar/06/worst-case-thinking-prevent-pandemics-coronavirus-existential-risk|title=Why we need worst-case thinking to prevent pandemics|date=2020-03-06|work=The Guardian|access-date=2020-04-11|language=en-GB|issn=0261-3077}}</ref>

State occupational safety plans are often focused on transportation, disposal, and risk assessment, allowing caveats for safety audits, but ultimately leaves the training in the hands of the employer.<ref>{{Cite web |url=https://www.aaas.org/sites/default/files/migrate/uploads/AAAS-Biosafety-report.pdf |title=Biological Safety Training Programs as a Component of Personnel Reliability |type=Workshop Report |publisher=American Association for the Advancement of Science |author1=Kavita Marfatia Berger |author2=Kathryn A. Luke |author3=Mark S. Frankel |author4=Jennifer L. Sta.Ana |year=2009 |access-date=2016-11-15 |archive-url=https://web.archive.org/web/20171230195019/https://www.aaas.org/sites/default/files/migrate/uploads/AAAS-Biosafety-report.pdf |archive-date=2017-12-30 |url-status=dead }}</ref>  22 states have approved Occupational Safety plans by OSHA that are audited annually for effectiveness.<ref name="osha.gov"/> These plans apply to private and public sector workers, and not necessarily state/ government workers, and not all specifically have a comprehensive program for all aspects of biohazard management from start to finish.  Sometimes biohazard management plans are limited only to workers in transportation specific job titles.  The enforcement and training on such regulations can vary from lab to lab based on the State's plans for occupational health and safety.  With the exception of DoD lab personnel, CDC lab personnel, First responders, and DoT employees, enforcement of training is inconsistent, and while training is required to be done, specifics on the breadth and frequency of refresher training does not seem consistent from state to state; penalties may never be assessed without larger regulating bodies being aware of non-compliance, and enforcement is limited.<ref>{{Cite web |url=http://www.councilforresponsiblegenetics.org/pageDocuments/T6CQ5HCITM.pdf |title=Biological Laboratories: Risks and Regulations |last=Buyon |first=Lucas |publisher=Council for Responsible Genetics |access-date=2016-11-15 |archive-url=https://web.archive.org/web/20160527192522/http://www.councilforresponsiblegenetics.org/pageDocuments/T6CQ5HCITM.pdf |archive-date=2016-05-27 |url-status=dead }}</ref>