New Entity CDC Select Agent Registration Process—A Practical Guide to Lessons Learned

Abstract

Entities planning to conduct work in the United States with biological select agents and toxins (BSAT) must be registered with either the Centers for Disease Control and Prevention (CDC) or the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). Information pertaining to registration is described in a Guidance Document for Completing Form 1 which is available on the National Select Agent Registry (NSAR) website; however, the registration process involves substantial preparation before and after the Form 1 is submitted, and no recommended strategy guides are available to assist with navigating through the process as a whole. The National Biodefense Analysis and Countermeasures Center (NBACC) successfully completed the registration process by employing, what we believe, are industry best practices as described in the “Critical Lessons Learned” text box to effectively streamline the application process. The purpose of this article is to benchmark and share these practices with the biocontainment community.

Keywords

New Registration Responsible Official Best Practices Form 1 and Lessons Learned

References

Animal and Plant Health Inspection Service (APHIS). Code of Federal Regulation 7 Part 331: Possession, use and transfer of select agents and toxins; 2012 [cited 2013]. Available from: www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title07/7cfr331_main_02.tpl.

Animal and Plant Health Inspection Service (APHIS). Code of Federal Regulation 9 Part 121: Possession, use and transfer of select agents and toxins; 2012 [cited 2013]. Available from: www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title09/9cfr121_main_02.tpl.

Centers for Disease Control and Prevention (CDC). Supplement F: Laboratory guidance appendix F6 guidelines for medical surveillance of laboratory personnel working with SARS-CoV; 2004a [cited 2013]. Available from: www.cdc.gov/sars/guidance/F-lab/app6.html.

Centers for Disease Control and Prevention (CDC). Clinical guidance on the identification and evaluation of possible SARS-CoV disease among persons presenting with community-acquired illness version 2; 2004b [cited 2013]. Available from: www.cdc.gov/sars/clinical/guidance.html.

Colella

, Johnson

, Fitch

, Weaver

. The endurance testing process: A methodology to verify the functionality of biocontainment, security and life safety systems in BSL-3 and BSL-4 laboratories. Appl. Biosafety., 2013; 18(1):18–23.

Higgins

, Weaver

, Fitch

, Johnson

, Pearl

. Implementation of personnel reliability program as a facilitator of biosafety and biosecurity culture in BSL-3 and BSL-4 laboratories. Biosec and Bioterror. 2013; 11(2):130–7.

ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories. International Organization for Standardization. 2005, confirmed 2010. Geneva, Switzerland.

National Select Agent Registry (NSAR). Security guidance for select agent or toxin facilities; 2012 [cited 2013]. Available from: www.selectagents.gov/resources/Security_Guidance_version_2_English.pdf.

National Select Agent Registry (NSAR). Guidance for suitability assessments; 2013a [cited 2013]. Available from: www.selectagents.gov/.

10.

National Select Agent Registry (NSAR). Occupational Health Program guidance document for working with Tier 1 select agents and toxins; 2013b [cited 2014]. Available from: www.selectagents.gov/resources/Occupational_Health_Program_Guidance_v3-English.pdf.

11.

National Select Agent Registry (NSAR). Resource manual; 2013c [cited 2014]. Available from: www.selectagents.gov/resources/Resource_Manual_All.pdf.

12.

Sandia National Laboratories. BioRAM; 2012. Available from: www.biosecurity.sandia.gov/BioRAM/ and www.biosecurity.sandia.gov/BioRAM/BiosecurityRAM.zip.

13.

U.S. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH). Biosafety in microbiological and biomedical laboratories. 5th ed.. Washington, DC: Government Printing Office; 2009 [cited 2012]. Available from: www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.

14.

U.S. Department of Health and Human Services (HHS). Code of Federal Regulation 42 Part 73: Possession, use and transfer of select agents and toxins; 2012 [cited 2013]. Available from: www.selectagents.gov/resources/CDC%20Select%20Agent%20Biennial%20Review%20Final%20Rule%202005%202012,pdf.