Guidelines, Licensing and Standards
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
Hazardous Waste Operations and Emergency Response CFR-1910.120
Biohazard HAZWOPER Requirement Letter of Interpretation
Outreach General Construction 10hr or 30hr (Please see what local requirements apply to you)
Medical Waste Regulation Explanation for Trauma and Infectious Substance Cleanup
FEMA
USEPA
Lead Renovation, Repair and Painting Program
USA and STATE Regulatory Information)
State Regulatory and Licensing Information
ABRA
Bio Recovery Site Risk Assessment (BSRA)
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 -Decontamination and Disinfection Biological Safety Laboratories
CDC – BioSafety Risk Level 1, 2, 3, 4 Defined
WHO – BioSafety Manual – Fourth Edition
BioSafety Cabinet Accreditation Program
BioSafety Cabinet video for Industry Info page
USDA – Emergency Management Guidelines for Animal Health
EPA – Registered Disinfectants
EPA – Microorganism Susceptibility
Illustration of Microorganism Susceptibility to EPA Registered Disinfectants v3
EPA – Biological Indicator Guidance
EPA – Selected EPA Registered Disinfectants
EPA – efficacy-requirements-antimicrobial-pesticides
FOOD SAFETY
Food Safety Modernization Act (FDA)
(FDA) HACCP Hazard Analysis and Critical Control Points.
CLANDESTINE DRUG GUIDANCE
Meth and Fentanyl Lab EPA Guidance Documentation
IAB First Responder PPE Guidance for Fentanyl
DEA Briefing Guide for First Responders
EPA Fact Sheet Document on Fentanyl
NIH Forced Degradation of Fentanyl
Oxidative Degradation of Fentanyl in Aqueous Solutions of Peroxides and Hypochlorites
Defense Science Journal, Vol. 61, No. 1, January 2011, pp. 30-35
HEALTH CARE and PHARMACEUTICAL
USP 797 Guidance for Pharmaceutical Compounding Laboratories
USP 800 Guidance for Pharmaceutical Compounding Laboratories
AORN (Aseptic Techniques for Environmental Cleaning – Terminal Cleaning)
CDC – Healthcare Infection Control Practices Advisory Committee (HICPAC)
Infection Control Risk Assessment (ICRA)
Cleanroom Classification Information
International Organization for Standardization (ISO)
FDA GMP Guidance for Aseptic Drug Manufacturing
EC guidelines on the Manufacture of Sterile Medicinal Products
STATE LICENSING INFORMATION
Georgia Crime Scene Cleaner Licensing
California Trauma Scene Waste Management Practitioners Licensing
Public Health Information
https://www.publichealth.org/c
https://www.publichealth.org/o
TRAUMA
IICRC – S-540
SOP Vault
Within this folder you will find Standard Operating Procedures written by Members and or the Bio Recovery Community. Disclaimer: These are third party documents and the American Bio Recovery Association (ABRA) nor its board of directors endorse or validate any third party information present on these documents. Documents are to be used as guidelines. If you have questions please reach out to the author for further guidance.
- Item Name: EPA Fogging and Misting Letter PDF (710.15 KB)
- Posted by: Administration
- Date Posted: 4/22/2021
- Details: EPA Fogging and Misting Letter – Disinfection