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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 clean-room standards.  

 

Disclaimer: These links will take you to third party sites.  ABRA does not endorse or validate any third party information present on these sites.   


 

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/laws-regs/regulations/standardnumber/1910/1910.120

Biohazard HAZWOPER Requirement Letter of Interpretation 

https://cdn.ymaws.com/www.americanbiorecovery.org/resource/resmgr/docs/guidance_documents/osha_biohazard_loi.pdf

Biological Agents

https://www.osha.gov/SLTC/biologicalagents/

Outreach General Construction 10hr or 30hr (Please see what local requirements apply to you) https://www.osha.gov/dte/outreach/construction/index.html

Medical Waste Regulation Explanation for Trauma and Infectious Substance Cleanup

https://www.osha.gov/laws-regs/standardinterpretations/2007-05-22?fbclid=IwAR2LJnvhKo6wJXJeG8ZTh4dk4z5g-Pq57GNqXPtXwGALMjgNBq3iVuYruvs

 

FEMA

Incident Command

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

 

ABRA

Bio Recovery Site Risk Assessment (BSRA)

https://cdn.ymaws.com/www.americanbiorecovery.org/resource/resmgr/docs/guidance_documents/bio_recovery_risk_assessment.pdf

 

REGULATED MEDICAL WASTE - OSHA

 

OSHA 1910.1030(b)* “Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and microbiological wastes containing blood or other potentially infectious materials.”

 

PHSMA - US DOT TRANSPORTATION (Please see state laws for further guidance and licensing requirements)

 

Regulated medical waste or clinical waste or (bio) medical waste means a waste or reusable material derived from the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical research, which includes the production and testing of biological products. Regulated medical waste or clinical waste or (bio) medical waste containing a Category A infectious substance must be classed as an infectious substance, and assigned to UN2814 or UN2900, as appropriate.   (State regulations for transportation of RMW may meet or exceed this transportation regulation please consult with your state department of soild waste or Environmental Protection for further guidance)

 

INFECTIOUS SUBSTANCE

 

DIVISION 6.2 (INFECTIOUS SUBSTANCE):

The US DOT defines an infectious substance as “a material known or reasonably expected to contain a pathogen.” [49 CFR 173.134] Pathogen is further defined as a microorganism (e.g., bacteria, viruses, parasites, fungi) or other agent, such as an infectious particle, that can cause disease in humans or animals. Examples are the Ebola virus and hoof-and-mouth disease and the cultures taken from them. Not all these pathogens are regulated the same way, if at all, and Division 6.2 is further divided into two categories:
 
Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. A Category A infectious substance must be assigned to identification number UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900 must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal.

 

Category B: An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes. A Category B infectious substance must be described as “Biological substance, Category B” and assigned identification number UN 3373.This does not include regulated medical waste, which must be assigned identification number UN 3291.

 

PHMSA - DOT - Transportation of Infectious Substances  Class A and Class B

Infectious Substances Presentation 

PHMSA - Infectious Substances Portal

Infectious Substances Overview

 

 

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

FDA bug book

https://www.fda.gov/media/83271/download?fbclid=IwAR3SwbU7tLEC3mM1WovS7F0dVj-flpyUQZWAJgf-MltUZJvYn5CxNQ7qLto

 

 

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 

DEA Briefing Guide for First Responders

https://www.dea.gov/sites/default/files/Publications/Final%20STANDARD%20size%20of%20Fentanyl%20Safety%20Recommendations%20for%20First%20Respond....pdf

EPA Guidance Document on Fentanyl

https://cdn.ymaws.com/www.americanbiorecovery.org/resource/resmgr/fentanyl_fact_sheet_final_ma.pdf

CDC Guidance Card on Fentanyl

https://www.cdc.gov/niosh/ershdb/emergencyresponsecard_29750022.html

NIH Forced Degradation of Fentanyl

https://www.ncbi.nlm.nih.gov/pubmed/20462721

Oxidative Degradation of Fentanyl in Aqueous Solutions of Peroxides and Hypochlorites

Defence Science Journal, Vol. 61, No. 1, January 2011, pp. 30-35

https://cdn.ymaws.com/www.americanbiorecovery.org/resource/resmgr/files/68-2939-3-pb.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

 

Public Health Information

https://www.publichealth.org/careers/

https://www.publichealth.org/online-degrees/dc/

 

TRAUMA

IICRC - S-540 

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

 

 

Contact Us

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

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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.