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INDUSTRY STANDARDS and GUIDANCE DOCUMENTATION

 

This page describes published standards and guidance documentation for the Biological/Biohazard Industry. Most of this can be cross referenced to help guide contractors in multi-market opportunities.  

On this page, you will find links to OSHA, BioSafety, Biohazard, Disinfection, Sterilization, Food Plant Sanitation, licensing programs, Terminal Cleaning, Aseptic process environments and cleanroom standards.     


 

OSHA

Bloodborne Pathogens CFR-1910.1030

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS

Hazardous Waste Operations and Emergency Response CFR-1910.120

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS

Outreach General Construction 10hr or 30hr (Please see what local requirements apply to you)

https://www.osha.gov/dte/outreach/construction/index.html

 

FEMA

Incident Command

https://www.fema.gov/incident-command-system-resources

 

TRAUMA

IICRC - S-540 

http://www.iicrc.org/standards/iicrc-s540/

 

BIOSAFETY AND DISINFECTION

CDC - Appendix B—Decontamination and Disinfection

https://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_appendixb.pdf

CDC - BioSafety Risk Level 1, 2, 3, 4 Defined

https://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_iv.pdf

WHO - BioSafety Manual - Third Edition

http://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf

BioSafety Cabinets

http://www.nsf.org/services/by-industry/pharma-biotech/biosafety-cabinetry/biosafety-cabinet-field-certifier-accreditation

BioSafety Cabinet video for Industry Info page

https://www.youtube.com/watch?v=afoqHBj291s

Canada - BioSafety Guidance

http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/ch8-eng.php

USDA - Emergency Management Guidelines for Animal Health

https://www.aphis.usda.gov/animal_health/emergency_management/downloads/sop/sop_cd.pdf

EPA - Registered Disinfectants

https://www.epa.gov/pesticide-registration/selected-epa-registered-disinfectants

EPA - Microorganism Susceptibility

https://www.epa.gov/sites/production/files/2015-10/documents/rutala_overview_of_current_disinfection_hierarchy_models_final.pdf

EPA - Efficacy Spectrum -

Illustration of Microorganism Susceptibility to EPA Registered Disinfectants v3

 

 

FOOD SAFETY

Food Safety Modernization Act (FDA)

http://www.fda.gov/Food/GuidanceRegulation/FSMA/

USDA  FSIS Sanitation Guide

https://www.fsis.usda.gov/wps/wcm/connect/27f6d5a2-7443-4268-9882-98d9b4b91eea/11_IM_SPS.pdf?MOD=AJPERES

 

 

CLANDESTINE DRUG GUIDANCE

Meth Lab EPA Guidance Documentation

https://www.epa.gov/sites/production/files/documents/meth_lab_guidelines.pdf

IAB First Responder PPE Guidance for Fentanyl

IAB_First_Responder_PPE_and_.pdf  

 

TRANSPORTATION AND DISPOSAL - Please see state laws for further guidance.

PHMSA - DOT - Transportation of Infectious Substances

http://www.phmsa.dot.gov/staticfiles/PHMSA/Hazmat/digipak/pdfs/presentation/Infectious_Substances(04_07).pdf

PHMSA - Trauma waste and OPIM Interpretation

http://www.phmsa.dot.gov/staticfiles/PHMSA/DownloadableFiles/Files/Interpretation%20Files/2013/130041.pdf

 

AIR FLOW AND CONTAINMENT

http://www.airflowdirection.com/ASHRAE%20Original%20Reprint.pdf

 

HEALTH CARE

USP 797 Guidance for Pharmaceutical Compounding Laboratories

http://www.usp797.org/

AORN (Aseptic Techniques for Environmental Cleaning - Terminal Cleaning)

http://www.aorn.org/guidelines/guideline-implementation-topics/aseptic-technique/environmental-cleaning

CDC - Healthcare Infection Control Practices Advisory Committee (HICPAC)

https://www.cdc.gov/hicpac/pubs.html

Infection Control Risk Assessment (ICRA)

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm

ICRA Permit

http://www.ashe.org/resources/tools/pdfs/assessment_icra.pdf

 

PHARMACEUTICAL

USP 797 Guidance for Pharmaceutical Compounding Laboratories

https://www.pppmag.com/documents/V2N5/v2n5pp16_cleancleanroom2.pdf

Cleanroom Classification Information

https://en.wikipedia.org/wiki/Cleanroom

International Organization for Standardization (ISO)

Cleanroom & Associated Controlled Environment Standards/Documents

FDA GMP Guidance for Aseptic Drug Manufacturing

http://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf

EC guidelines on the Manufacture of Sterile Medicinal Products

http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf

 

STERILIZATION VALIDATION

Biological Indicator Guidance

http://www.fda.gov/RegulatoryInformation/Guidances/ucm071261.htm

 

STATE LICENSING INFORMATION

Georgia Crime Scene Cleaner Licensing

HB 149 2017-2018 Regular Session GA Crime Scene Cleaner Bill

HB 149 2017-2018 Regular Session

 

California Trauma Scene Waste Management Practitioners Licensing

https://www.cdph.ca.gov/certlic/medicalwaste/Pages/TraumaScene.aspx

 

News: Georgia Crime Scene Cleaner Law

Bill: License crime scene cleaners - Rome News-Tribune: Local

 

NYC Trauma Scene Guidelines

http://www1.nyc.gov/assets/doh/downloads/pdf/epi/trauma-scene-guidelines.pdf

 

Contact Us

American Bio Recovery Association
300 New Jersey Avenue NW Suite 900 PMB #9031
Washington, DC 20001
Phone: 888-979-2272

Connect With Us

Our mission

ABRA’s objective is “to achieve and maintain the highest levels of competence among members in the performance of their profession. To teach, instill and require the highest technical, ethical and educational standards.” ABRA certified firms are required to maintain proper insurance, OSHA compliance, Bloodborne Pathogen training records, respirator fit testing, proper handling of biohazardous waste and other laws or requirements in order to maintain good standing with the American Bio-Recovery Association aka ABRA.