Position Statements, Reviews & Comments
Comments and Recommendations for HHS/USDA Proposed Rulemaking – Select Agent Regulations (Review of Proposed Rules – published in the Federal Register Vol 89, No. 20, dated January 30, 2024)(pdf), a letter written by Luis Ochoa Carrera, MSc, President, ABSA International, March 30, 2024
ABSA International’s Response to Proposed Legislation for a Centralized Management Strategy for Biosafety, Biosecurity, and Biorisk Management(PDF 116KB), February 14, 2022
Comments to GAO in response to their review of Department of Health and Human Services (HHS) High-Risk Research Oversight (105455)(PDF 408KB)
a letter written by LouAnn Burnett MS, CBSP(ABSA), President, ABSA International, to Jasleen K. Modi, Senior Analyst, Health Care, U.S. Government Accountability Office, February 7, 2022
Summary of Changes to the Biosafety in Microbiological and Biomedical Laboratories 6th Edition (BMBL-6)(PDF 408KB)
This Summary of Changes was prepared by the ABSA International Technical and Regulatory Review Committee (TRR), May 13, 2021
ABSA International comments re: 2018 National Biodefense Strategy (PDF 2MB)
a letter written by Domenica (Dee) Zimmerman, President, ABSA International, to Roberth P. Kadlec, HHS Assistant Secretary for Preparedness and Response, November 29, 2018
ABSA International review: FSAP Policy Statement: Select agent contained in formalin-fixed, paraffin-ebedded tissue, released July 31, 2018 (PDF 2MB)
a letter written by Patrick Condreay, PhD, RBP, President, ABSA International, August, 2018
ABSA International reviews: FSAP Policy Statement: Registration and Inspection of Effluent Decontamination Systems released June 19, 2018(PDF 2MB)
a letter written by Patrick Condreay, PhD, RBP, President, ABSA International, to Adis Dijab and Samuel Edwin, Directors, Federal Select Agent Program, July, 2018
ABSA International review: USDA APHIS Draft Environmental Impact Statement and Preliminary Pest Risk Assessment for Permit for Release of Genetically Engineered Citrus tristeza virus. (PDF 3MB)
a letter written by Patrick Condreay, PhD, RBP, President, ABSA International, June, 2018
ABSA International comments re: Updated Draft Biosafety/Biocontainment Guidance Document Available for Comment, CDC, SA Gram, August 3, 2017.(PDF 2MB)
a letter written by Maureen O’Leary, PhD, CBSP, President, ABSA International, to the Centers for Disease Control and Prevention, Division of Select Agents, Toxins and Animal and Plant Health Inspection Service, August 23, 2017
ABSA International comments on: Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes (PDF 1MB)
a letter written by Melissa Morland, MS, RBP, CBSP, President, ABSA International, to Dr. Brinda Dass, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, April 13, 2016
ABSA comments re: proposed biennial review of the Select Agent and Toxin List, released on January 19, 2016.(PDF 220KB)
a letter written by Melissa Morland, MS, MBA, RBP, CBSP, President, ABSA International, to the Animal and Plant Health Inspection Service, Agriculture Select Agent Services, 14 March, 2016
ABSA comments re: Federal Select Agent Program (FSAP) Policy Statement entitled, “Inactivated Bacillus anthracis”, released on November 30, 2015.(PDF 220KB)
a letter written by Melissa Morland, MS, MBA, RBP, CBSP, President, ABSA International, to the Centers for Disease Control and Prevention, Division of Select Agents and to the Toxins and Animal and Plant Health Inspection Service, Agriculture Select Agent Services, 11 February, 2016
ABSA comments re: Proposed Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), Document number 2015-26388, 80 CFR 62543.(PDF 171KB)
a letter written by Melissa Morland, MS, MBA, RBP, CBSP, President, ABSA International, to the Office of Science Policy, National Institutes of Health, 30 November, 2015
ABSA Response to October 29, 2015 White House Biosafety Memo(PDF 231KB)
ABSA comments re: Coordinated Framework for the Regulation of Biotechnology(PDF 448KB)
a letter written by Melissa Morland, MS, MBA, RBP, CBSP, SM (NRCM), President, ABSA International, to members of the National Science and Technology Council, Emerging Technologies Interagency Policy Coordination Committee, Office of Science and Technology Policy 12 November, 2015
RE: Office of Science and Technology Policy request for comments regarding impact of the Select Agent Regulations (PDF 86KB)
a letter written by Marian Downing, RBP, CBSP, President, ABSA, to Gerald Epstein, PhD Co-Chair, Fast Track Action Committee, Deputy Assistant Secretary for Chemical, Biological, Radiological, and Nuclear Policy, U.S. Department of Homeland Security 10 April, 2015
ABSA Position Paper regarding the July 16, 2014 CDC Hearing and GAO Report High Containment Laboratories: Recent Incidents of Biosafety Lapses (PDF 423KB)
written by the ABSA Unified Oversight Task Force, 25 March, 2015
ABSA Final Comments on the Drafted Table of Contents of the Agriculture Biosafety/Biocontainment Manual (AgBMBL) – a companion to the NIH/CDC publication, “Biosafety in Microbiological and Biomedical Laboratories” (PDF 256KB)
a letter written to the USDA Animal and Plant Health Inspection Service by Marian M. Downing, RBP, CBSP, President, ABSA, 9 February, 2015
America Biological Safety Association (ABSA) Position Paper on Ebola (PDF 27KB)
12 December, 2014
White House memorandum: Enhancing Biosafety and Biosecurity in the United States(PDF 353KB)
a memorandum written by Lisa O. Monaco, Assistant to the President for Homeland Security and Counterterrorism, and John P. Holdren, Assistant toe the President for Science and Technology, 19 Aug, 2014
Re: CDC Anthrax Lab Incident Hearing and Subsequent GAO Report High Containment Laboratories: Recent Incidents of Biosafety Lapses(PDF 1.16MB)
a letter written by the ABSA Legislative Committee to the US Energy and Commerce Committee, Oversight Investigations, 31 July, 2014
Press Release: ABSA International (ABSA) Response to Recent Events at the Centers for Disease Control and Prevention (CDC)(PDF 225KB), 16 July, 2014
To the Editors of Newsweek regarding the March 13, 2014 article, “The Cure May Kill You: The Only Thing Scarier than Bio-Warfare Is the Antidote.”(PDF 196KB)
a letter written by Paul J. Meechan, PhD, RBP, CBSP, President, ABSA, 2 April, 2014
CLSI Guideline M29-A4 (Draft 2) Protection of Laboratory Workers From Occupationally Acquired Infections; Draft Guideline — Fourth Edition(PDF 649KB)
a letter written by Barbara Fox Nellis, SM(NRCM), RBP, CBSP, President, ABSA, 22 August, 2013
ABSA Request for Comments on proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules – Streamlining Review of Certain Human Gene Transfer Trials that Pose a Low Biosafety Risk (PDF 72KB)
a letter written by Barbara Fox Nellis, SM(NRCM), RBP, CBSP, President, ABSA, 12 June, 2013
