USDA Policies = and Procedures on Biohazardous Waste Decontamination, Management, and = Quality Controls at Laboratories and Technical Facilities

U.S.

= Department of=20 Agriculture

Washington, = D.C.

DEPARTMENTAL = REGULATION

= NUMBER:

9630-001

SUBJECT: =

USDA Policies and Procedures on Biohazardous = Waste=20 Decontamination, Management, and Quality Controls at Laboratories = and=20 Technical Facilities

DATE: June 18, = 2009

OPI: Agricultural Research=20 Service

1. =20 PURPOSE

&nbs= p; =20 Decontamination, sterilization, and disinfection procedures in a = research=20 or diagnostic environment vary, depending on the capabilities of the = facility=20 and the biological hazards (biohazard) being handled. Existing = Department=20 of Agriculture (USDA) Department Manuals (DM) on Security Policies for = Biosafety=20 Level (BSL)-3 and Labs excluding BSL-3 (DM9610-1 and DM9610-2) do not = address=20 biohazardous waste decontamination, management and quality = control. This=20 manual should provide USDA-wide biosafety policies for biological waste=20 management and quality control at USDA facilities, including general = information=20 on decontamination methods and technologies, methods for validating=20 decontamination efforts, and information on security and employee safety = issues.=20

2. =20 SPECIAL INSTRUCTIONS

The=20 policies and procedures described herein are subject to review on a = 5-year basis=20 unless conditions warrant earlier review.

3. =20 STATEMENT OF POLICY

Biohazardous agents used at = USDA=20 facilities must be decontaminated prior to disposal or discharge. Decontamination and disposal = of=20 biohazardous wastes should be conducted in accordance with applicable = USDA,=20 Federal, State, local, facility and/or host nation environmental = standards.=20 General procedures for=20 decontamination, destruction, and disposal are described in this Manual, = but it=20 may be necessary to use additional resources to identify and develop = appropriate=20 biohazardous waste management on a case-by-case basis.

=20

a. =20 The preferred methods of decontamination, destruction, and = disposal of=20 many infectious/etiologic agents, zoonotic agents, veterinary pathogens, = and=20 biohazards are steam sterilization (autoclaving), chemical inactivation = with=20 appropriate biocidal solutions, or incineration in an appropriately = permitted=20 hospital/medical/infectious waste and/or pathological waste = incinerator(s).

b. =20 Infectious/etiologic agents or other biohazards awaiting = decontamination,=20 destruction, and disposal will be properly contained and labeled at the=20 appropriate biosafety/biocontainment level according to the risk = presented by=20 the biohazard.

4. =20 ABBREVIATIONS

BSL &nbs= p; =20 Biosafety level

CDC &nbs= p; =20 U.S. Centers for Disease = Control

CFR &nbs= p; =20 Code of Federal Regulations

DM &nbs= p; =20 Departmental Manual

EPA &nbs= p; =20 U.S. Environmental = Protection=20 Agency &nbs= p; =20

FIRFA &nbs= p;=20 Federal Insecticide, = Fungicide,=20 and Rodenticide Act

FDA &nbs= p; =20 U.S. Food and Drug = Administration

FRC &nbs= p; =20 Federal=20 Records Center

NARA &nbs= p;=20 National Archives and Records Administration

OSHA &nbs= p;=20 Occupational Safety and Health Administration

PPE &nbs= p; =20 Personal Protective Equipment

PPQ &nbs= p; =20 Plant Protection and Quarantine

SOP &nbs= p; =20 Standard Operating Procedure(s)

UN &nbs= p; =20 United Nations

USDA &nbs= p; =20 U.S. Department of = Agriculture

UV &nbs= p; =20 Ultraviolet

5. =20 DEFINITIONS

=20

Antimicrobial - An agent that = kills or=20 suppresses the growth of microorganisms.

Antiseptic =96 A substance = that prevents=20 or arrests the growth or action of microorganisms, either by inhibiting = their=20 activity or destroying them.

Bioburden - The number and = types of=20 viable microorganisms with which an item is contaminated; also = known as=20 "bioload" or "microbial load."

Biocide - A chemical or = physical agent=20 that kills all living organisms, both micro and macro, as well as=20 pathogenic and nonpathogenic microorganisms. Microbiocide = specifies an=20 agent that kills microorganisms. = Because a biocide kills spores as well as vegetative = cells, it is=20 presumably a sterilizing agent.

Biohazard - an infectious = agent, or=20 hazardous biological agent, or part thereof, regardless of origin = (naturally=20 occurring, bioengineered, or synthesized component of any such = microorganism or=20 infectious substance), that presents a real or potential risk to humans, = animals=20 or plants, either directly through infection, or indirectly through the=20 disruption of the environment. Biohazards include certain = types of=20 recombinant DNA; organisms and viruses infectious to humans, animals or = plants=20 (e.g., parasites, viruses, bacteria, fungi, prions, and rickettsia); and = biologically active agents (i.e.,, toxins, allergens, and venoms) that = may cause=20 disease in other living organisms or significantly affect the = environment,=20 community, commerce, or trade agreements.

Biohazard Incident =96 An = incident that=20 may include human exposure to an infectious, potentially infectious, or = zoonotic=20 agent; a release of a biohazard into the environment; escape of infected = animals=20 or vectors; biohazard spills outside of a primary containment device; = loss or=20 theft of biohazardous agents; or other loss of containment or equipment = failure=20 in conjunction with a biohazard which may lead to a release of a = hazardous agent=20 within the laboratory environment or outside the laboratory = environment.

Biohazardous waste types: Waste items as described = in section=20 7 of this manual generated at USDA facilities.

Biological Indicator (BI) =96 = A=20 standardized preparation of nonpathogenic (surrogate) microorganisms (in = many=20 cases bacterial endospores) that are highly resistant to specific = sterilization=20 methods. BIs are used = during the=20 sterilization process to provide additional evidence that the = sterilization=20 method was effective in achieving sterilization. BIs can be dried preparations = on filter=20 paper (spore strips), stainless steel coupons, or aluminum foil, or can = be a=20 combined unit consisting of a paper carrier of the BI and a vial of = growth=20 medium containing a pH indicator system.

Biological Toxin or Biotoxin = =96 A=20 broad range of substances, predominantly of natural origin but = increasingly=20 accessible by modern synthetic methods, that may cause death or severe=20 incapacitation at relatively low exposure levels. Biological toxins include = metabolites of=20 living organisms, degradation products of dead organisms, and materials = rendered=20 toxic by the metabolic activity of microorganisms. =

Biosafety=20 Level=20 (BSL)- Four BSLs are described in the 5^th edition of = Biosafety in Microbiology and = Biomedical=20 Laboratories, published by the Centers for Disease Control (CDC) and = the=20 National Institutes of Health. These consist of increasingly protective=20 combinations of laboratory practices and techniques, safety equipment, = and=20 laboratory facilities. = Each=20 combination is specifically appropriate for the operations performed, = the=20 documented or suspected routes of infectious agent transmission, and the = laboratory function or activity.

Common Carrier- A U.S. = Department of=20 Transportation licensed commercial carrier contracted to transport = biohazardous=20 waste.

Contamination =96 The = introduction of=20 microorganisms or biological toxins to items or surfaces, or into = tissues or=20 sterile material.

D-Value =96 The time required = to=20 inactivate 90% of the cell population or to reduce the microbial = population=20 to one-tenth of its original number (a one-logarithm reduction).

Decontamination =96 = Disinfection or=20 sterilization of articles contaminated with toxins or agents to make the = articles safe for use or disposal.

Disinfectant =96 A chemical = agent that=20 eliminates a defined scope of pathogenic organisms, but not necessarily = all=20 microbial forms (e.g., bacterial endospores).

Disinfection =96 The = selective=20 elimination of certain undesirable microorganisms to prevent their = transmission=20 to a susceptible host.

Disinfestation =96 = Extermination or=20 destruction of insects, rodents, or other animal forms that transmit = disease or=20 are otherwise considered pests and that may be present on plants, = animals,=20 humans, or in their immediate environments.

Droplet nuclei =96 Particles = of 5 =B5m=20 diameters or less, that are formed by dehydration of airborne droplets = and=20 capable of air dispersal.

Etiologic agent =96 Any = viable=20 microorganism or its toxin that has the capacity to cause human = disease.

F-value =96 The time in = minutes required=20 to kill all the spores in suspension at a temperature of 121=B0C = (250=B0F). By calculating and converting = the=20 temperature-time equivalents of the F-value during the heating and = cooling=20 of the sterilization cycle and adding them together, the holding time at = sterilization temperature may be reduced and the product subjected to = less=20 heating than otherwise would be required.

Federal=20 Insecticide, Fungicide, and Rodenticide Act (FIFRA) =96 Provides the = basis for=20 regulation, sale, distribution, and use of pesticides in the United=20 States. =20 FIFRA authorizes the U.S. Environmental Protection Agency (EPA) = to review=20 and register pesticides for specified uses. EPA also has the authority to = suspend or=20 cancel the registration of a pesticide if subsequent information shows = that its=20 continued use would pose unreasonable risks. Some key elements of FIFRA = include:=20

=B7 = ; =20 product licensing statutes that require = the=20 registration of pesticide products with the EPA before their = manufacture,=20 transport, and sale;

=B7 = ; =20 registration based on a risk/benefit=20 standard;

=B7 = ; =20 strong authority to require data, and the = authorization to issue Data Call-ins;

=B7 = ; =20 regulation of pesticide use through = labeling,=20 packaging, composition, and disposal;

=B7 = ; =20 emergency exemption authority that = permits=20 approval of unregistered uses of registered products on a time limited = basis;=20 and

=B7 = ; =20 authorization to suspend or cancel a = product's=20 registration, including the appeals process, adjudicatory functions, = etc.

Fomite(s) =96 Inanimate = objects that may=20 transmit infectious microorganisms, such as pens, eating utensils, = equipment,=20 combs, etc.

Fumigation =96 A means of = decontaminating=20 an enclosed space and the articles enclosed in that space by using a gas = or=20 vapor method. Usually the = agent=20 selected can inactivate bacterial endospores.

Germicide =96 An agent that = destroys=20 microorganisms, especially pathogenic organisms.=20 As commonly used, the term is associated with the death of all=20 disease-producing microorganisms, but it does not necessarily = include the=20 capability of destroying bacterial spores.

Infection =96 The = establishment of a=20 pathogenic microorganism within a susceptible host after transmission = via a=20 viable route and subsequent host invasion.

Pasteurization =96 A process developed by = Louis Pasteur=20 for heating milk, wine, or other liquids to 60=B0 to 100=B0C = (140^o to=20 212^oF) for approximately 30 minutes to significantly reduce = or kill=20 the number of pathogenic and spoilage organisms.

Prion(s) =96 Proteinaceous = infectious=20 particles that lack nucleic acids. =20 They are thought to consist of an abnormal isoform of a normal = cellular=20 protein highly resistant = to=20 treatments (e.g., moderate heat, protein digesting enzymes, radiation, = and=20 formalin) that would inactivate typical proteins, viruses, or = bacteria. Complete inactivation may not = always be=20 possible, but all attempts should be made to ensure that adequate=20 decontamination is met. The=20 World=20 Health Organization=92s publication, =93Infection Control Guidelines for = Transmissible Spongiform Encephalopathies,=94 provides = internationally-accepted=20 guidance on handling Prion disease agents; it is located=20 at:

http= ://whqlibdoc.who.int/hq/2000/WHO_CDS_CSR_APH_2000.3.pdf).

Select Agent and/or Toxin = - A biological agent or toxin = listed in 7=20 CFR 331.3 (PPQ); 9 CFR 121.3 and 9 CFR 121.4 (VS); and 42 CFR 73.3 and = 42 CFR=20 73.4 (CDC) (See =93Overlap Select Agent and/or Toxin=94).

Source Reduction - The = process of=20 removing certain items and/or materials from a contaminated site for = further=20 treatment and reuse or disposal; cleaning items remaining on site prior = to the=20 main decontamination activity; and/or cleaning surfaces. The latter step = is=20 usually performed in conjunction with fumigation remedies. For cleanups that only involve = the=20 application of liquids to nonporous surfaces, this step may provide the = main=20 remediation activity. = When=20 effectively conducted, source reduction:

=B7 = ; =20 Reduces the number of potentially = contaminated=20 items and/or materials present;

=B7 = ; =20 Ensures that any material that might = inhibit=20 decontamination is removed; and

=B7 = ; =20 Reduces high contamination levels before = full=20 decontamination.

Spaulding Classification =96 = Strategy=20 suggested by Dr. E. H. Spaulding in 1972 that divides medical devices = into three=20 infection risk categories (Critical, Semi-critical and Non critical), = based on=20 use and types of tissue they contact. =20 To complement the categorization of medical and surgical devices, = three=20 levels of germicidal action (High, Intermediate, and Low) were developed = to=20 carry out disinfection strategies in healthcare settings.

Sterile = =96 Free from=20 living microorganisms.

Sterility Assurance Level = (SAL) =96 The=20 probability of a viable microorganism being present on a product unit = after=20 sterilization. SAL is = normally=20 expressed as 10-x. = SAL of=20 10-6 is most often used for sterile devices and drugs.

Sterilization =96 A carefully = monitored=20 process that will assure that the probability of an item being = contaminated by a=20 microbe to be equal to or less than one in a million = (10⁼⁹⁶⁶)

Toxin - See=20 Biological Toxin

USDOT regulated medical waste or = clinical=20 waste or (bio) medical waste =96 Defined in 49 CFR=20 =A7 173.134, means a waste or reusable material = derived=20 from the medical treatment of an animal or human, which includes = diagnosis and=20 immunization, or from biomedical research, which includes the production = and=20 testing of biological products. Regulated medical waste or clinical = waste or=20 (bio) medical waste containing a Category A infectious substance must be = classed=20 as an infectious substance, and assigned to UN2814 or UN2900, as=20 appropriate.

=B7 = ; =20 Category=20 A, UN 2814- Infectious substances affecting humans and animals: An=20 infectious substance in a form capable of causing permanent disability = or=20 life-threatening or fatal disease in otherwise healthy humans or animals = when=20 exposure to it occurs.

=B7 = ; =20 Category=20 B, UN 2900- Infectious substances affecting animals only: An = infectious=20 substance that is not in a form generally capable of causing permanent=20 disability of life-threatening or fatal disease in otherwise healthy = humans and=20 animals when exposure to it occurs.

=B7 = ; =20 Category=20 B, UN 3373- Biological substance transported for diagnostic or = investigative=20 purposes.

=B7 = ; =20 Regulated=20 Medical Waste, UN 3291- Waste or reusable material derived from = medical=20 treatment of an animal or human, or from biomedical research, which = includes the=20 production and testing of biological products.

Virucide =96 An agent that = destroys or=20 inactivates viruses to make them noninfective, especially a chemical=20 substance used on living tissue. The word virucide is a=20 misnomer because the ending "cide" means kill, and the virus = by=20 itself is not a living entity. Thus, we do not say a virus is killed, = but that a=20 virus is inactivated.

Z-value =96 A measure of the = way the=20 D-value changes with temperature for a particular organism. It may be considered the slope = of the=20 logarithm of the D-value against temperature and the number of degrees = to change=20 the D-value by a factor of 10. It=20 is useful for comparing the death rate of spores with the destructive = effect on=20 the product over an equivalent temperature range.

6. =20 PERSONNEL RESPONSIBLE FOR BIOHAZARDOUS WASTE MANAGEMENT

Areas of = Responsibility

This section outlines = individual=20 responsibilities for implementation of biohazardous waste disposal = policies and=20 procedures.

a. =20 Agency

(1) = = Administrator or Agency Head. The Administrator is = responsible for=20 ensuring agency compliance with USDA biohazardous waste policies and = procedures,=20 and designates the agency official (Deputy Administrator or equivalent) = who will=20 ensure compliance implementation.

(2) = Deputy=20 Administrators or equivalent. =20 The Deputy Administrators ensure USDA biohazardous waste policies = and=20 procedures are implemented at all sub-agency levels, and designate an = Agency=20 Biosafety Officer or equivalent.

(3) = = Agency Biosafety Officer or = equivalent. The Agency Biosafety Officer = is=20 responsible for ensuring adherence to all agency biohazardous waste = policies and=20 procedures, which includes reporting all biohazardous waste incidents to = the=20 designated Agency official.

b. =20 Facility

(1) = Center=20 Director, Laboratory Chief or Director, or Research Leader or = equivalent.=20 The Center Director = ensures the=20 implementation of biohazardous waste policies and procedures at their = facility=20 or institute and also designates a Location = Biosafety/Biosecurity/Quarantine=20 Officer or equivalent.

(2) = Location=20 Biosafety/Biosecurity/Quarantine Officer(s) or equivalent. The Location Biosafety = Officer(s) works=20 with local line managers, scientists, and research personnel to ensure = the=20 facility is in compliance with agency and Department policy on = biohazardous=20 waste disposal. S/he = reports all=20 biohazardous waste incidents through Center or Location Management to = the Agency=20 Biosafety Officer or designated Agency Official.

(3) = USDA Scientists and Research = personnel. All USDA Scientists and = Research=20 personnel are responsible for:

=B7 = ; =20 staying informed about hazardous = biological=20 agents in their work areas;

=B7 = ; =20 adhering to biohazardous waste disposal = policies=20 and procedures; and

=B7 = ; =20 Ensure that their employees are aware of = hazards=20 associated with biohazards or biohazardous waste(s) and are = appropriately=20 trained on the applicable regulations, standard operating procedures, = emergency=20 procedures, security and safety procedures.

=B7 = ; =20 informing supervisors (or designee) and = the=20 Location Biosafety/Security/Quarantine Officer(s) of all biohazardous = waste=20 disposal incidents.

c. Development = of Location=20 Biohazard Waste Management &nbs= p; = ; =20 Plan

(1) = = DR=20 4400-007, Biological Safety Program, dated May 19, 2006, (www.oci= o.usda.gov/directives/doc/DR4400-007.htm)=20 requires that affected personnel must be provided site-specific = Biohazard=20 Control Plans which contain specific information about biological = hazards at=20 their worksite.

(a) = The=20 Biohazard Control Plan must include provisions for the safe handling and = disposal of hazardous biological agents, and can be incorporated into = existing=20 plans, such as the Chemical Hygiene Plan (Laboratory Safety) or Hazard=20 Communication Plan--both mandated by the Occupational Safety and Health=20 Administration (OSHA)--or the Biohazardous Control Plan.

(b) =20 Whether it is incorporated into existing plans or exists as an=20 independent document, the directives contained in the Biohazard Control = Plan=20 should be in accordance with the policy and procedures for = decontamination,=20 destruction, and disposal of hazardous waste as described in this = Manual.

d. =20 Biohazardous Waste Incident Reporting

All=20 USDA scientists and research personnel are responsible for reporting any = biohazardous waste incidents, regardless of severity, to their = supervisor or=20 designee and to the Location Biosafety Officer.

(1) = The=20 notification must be made by phone or in person.

(2) = ; =20 After investigating the circumstances that are = reported,=20 the Location Biosafety Officer will determine if a biohazardous waste = incident=20 has occurred.

(3) = ; =20 The Location Biosafety Officer is responsible = for=20 reporting biohazardous waste incidents to the appropriate line = management and/or=20 the Responsible Official for select agents and toxins. Line management is responsible = for=20 reporting the incident through the the normal management communication = structure=20 to the Agency Biosafety Officer or equivalent for incidents involving = potential=20 occupational exposure or illness, environmental release or a reportable = incident=20 involving a select agent.

(4) = Once=20 an investigation of the situation is complete, the supervisor will = report the=20 findings and corrective actions taken through the normal management=20 communication structure. =

(5) = The=20 Agency Biosafety Officer or equivalent is responsible for reporting any=20 biohazardous waste incidents to the designated Agency official.

(6) =20 Incidents related to select agents and toxins must be reported to = the=20 Agriculture Select Agent Program at 301-734-5960 (Or if registered with = CDC=20 Select Agent Program at 404-718-2000). =20 When responding to these incidents, the Responsible Official = should=20 follow the requirements of 7 CFR 331.19, 9 CFR 121.19 or 42 CFR 73.19-=20 Notification of a theft, loss, or release. =20

7. =20 TYPES OF BIOHAZARDOUS WASTE GENERATED AT USDA

USDA is = composed of a=20 number of agencies and offices. =20 At least 6 = agencies have=20 diagnostic or research laboratories, animal research facilities, and = containment=20 greenhouse facilities. = USDA=20 diagnostic and research operations generate a range of biological waste=20 products. The appropriate = precautionary procedures and the most effective decontamination methods = vary for=20 different pathogens and waste streams, and the selection of any waste = management=20 method should only be done after a careful evaluation and risk = assessment is=20 performed. Various = disinfection=20 methods are described in subsequent sections of this document.=20

The following = is a list=20 of the many categories/types of biological waste generated in USDA = facilities,=20 but it is not comprehensive. =20 Biological waste products not specified in this section are to be = handled=20 in a manner providing maximum protection to facility personnel, public = health,=20 U.S. Agriculture and to the environment. =20

All Federal, = State,=20 local, and facility regulations must be consulted and followed for the=20 definition of biohazardous wastes and waste disposal.

a. =20 Cultures, stocks of etiologic or infectious agents, and = associated=20 biologicals (including but not limited to all agents, whether designated = as=20 pathogens or not):

(1) =20 Specimens from veterinary, diagnostic, regulatory, pathology, and = research laboratories related to testing of products for animals, plants, = food, soil,=20 etc);

(2) =20 Diagnostic sample cultures, including all inoculated media used = to=20 isolate or enumerate microorganisms regardless of final isolation = result;

(3) =20 Incubated food samples, including the initial dilution, recovery, = or=20 enrichment culture of the food sample;

(4) =20 Quality control cultures;

(5) =20 Disposable culture/Petri dishes;

(6) =20 Devices used to manipulate specimens and devices used to = transfer,=20 inoculate, and mix cultures, including disposable and reusable items = (reusable=20 items include but are not limited to blender jars and blades, glass = pipettes,=20 scissors, knives, dilution bottles, ring slides, filter units, forceps, = and=20 funnels);

(7) =20 Wastes from the production of biologicals;

(8) = Waste=20 water from containment greenhouses;

(9) = All=20 microorganisms constructed using rDNA; and

(10) = Discarded live=20 and attenuated vaccines.

b. =20 Carcasses, body parts, and bedding from animals exposed to = pathogens in=20 research/diagnostics or that are used for diagnostics and may naturally = harbor=20 pathogens

c. =20 Plant specimens or debris, seeds, or soil exposed to plant = pathogens,=20 infectious material, insects under a plant pest permit (PPQ 526), or = plant=20 materials and associated pests

d. =20 All contaminated and uncontaminated sharps, including:

(1) =20 Needles and syringes

(2) =20 Scalpels, razors, and microtome blades

(3) =20 Pasteur pipettes

(4) =20 Slides and cover plates

(5) =20 Broken glass

e. =20 Laboratory wastes, including but not limited to:

(1) =20 Specimen containers

(2) =20 Histology samples and other fixed slides or wax embedded = tissues

(3) =20 Disposable personal protective equipment (gloves, lab coats, = masks, and=20 aprons)

(4) =20 Contaminated culture containers (Petri dishes, flasks, cell = culture=20 flasks, pipette tips, disposable pipettes, vials, tubing,=20 etc.)

(5) =20 Towels, absorbent surface liners, or underpads

(6) = Cell=20 culture materials

(7) = Test=20 or diagnostic kits, enzyme-linked immunosorbent assay equipment, lateral = flow=20 devices, and spent pH test paper

(8) =20 Disposable inoculating loops and needles, colony spreaders, and = swabs

(9) =20 Sample bags and collection and transport systems

(10) Filters = and=20 disposable filter units.

f. =20 Human blood, blood products, and body fluids, including = solidified blood=20 and body fluids

g. =20 Prions, including:

(1) =20 Abnormal host proteins

(2) =20 Transmissible Spongiform Encephalopathy = agents

(3) =20 Proteins resistant to moderate heat, digestion enzymes, = radiation, and=20 formalin

h. =20 Biological toxins, including:

(1) =20 Poisons of natural origin

(2) =20 Poisons of natural origin synthetically = produced

(3) = Toxic=20 metabolites of living organisms

(4) =20 Degradation products of dead organisms

(5) =20 Materials rendered toxic by the metabolic activity of=20 microorganisms

i. = ; =20 Select Agents: All laboratories working with = Select=20 Agents must adhere to the requirements in 42 CFR part 73, 9 CFR part 121 = and 7=20 CFR part 331, as well as the most current version of any and all = relevant USDA=20 manuals.

j. = ; =20 Multihazardous Waste: Waste with multiple type = hazards=20 including two or more of the following: radioactive, biohazardous = agent(s), or=20 hazardous chemical(s). If the multihazardous waste contains a = biohazardous=20 agent(s), inactivation of the biohazard(s) is usually the first step in = the=20 disposal process. After inactivation of the biohazard the waste will be = treated=20 as radioactive or hazardous chemical waste as appropriate. Contact your = location=20 Biosafety Officer and/or equivalent for appropriate inactivation = methods.

8. =20 BIOHAZARDOUS WASTE SEGREGATION, PACKAGING, LABELLING, AND = COLLECTION

a. =20 Biohazardous/infectious waste must be segregated from the general = trash.

b. =20 Packaging material must be selected that is appropriate for the = type of=20 waste handled (e.g., plastic bags for solid or semisolid infectious = waste;=20 puncture resistant containers for sharps; and bottles, flasks, or tanks = for=20 liquids).

c. =20 Suitable containers must be used for the intended treatment, = (e.g.,=20 incineration requires combustible containers). Suitable containers for sharps = include;=20 metal, rigid plastic, and heavy cardboard; containers that are = compatible with=20 selected treatment processes (NOTE: State and local = regulations/requirements for=20 sharps containers may vary).

d. =20 Primary and secondary containment must be adequate to prevent = release of=20 biohazardous constituents into the environment.

e. =20 Packaging containers/materials must maintain its integrity during = storage=20 and transportation.

f. =20 Biohazardous/infectious waste or packaged biohazardous/infectious = waste=20 shall not be compacted using a trash compactor prior to = decontamination.

g. =20 Biohazardous waste Storage time should be minimized.

h. =20 Biohazard bags should be sealed and containerized in = leak-proof/puncture=20 resistant secondary containment appropriate for treatment or = transport. Autoclave Bags used in steam=20 sterilization should be loosely closed during autoclaving to allow for = steam=20 circulation within the bag.

i. =20 Liquid wastes must be in capped or tightly stoppered bottles or = flasks=20 and containerized in leak-proof/puncture resistant secondary containment = as=20 appropriate for transportation. =20 Liquid waste vessels should never be tightly capped during steam=20 sterilization (autoclaving).

j. =20 The universal biological hazard symbol must be visible on = infectious=20 waste containers.

k. =20 Appropriate labeling or color coding should be used to = differentiate=20 decontaminated from non-decontaminated waste.

l. = ; =20 Waste moved within the facility for treatment or = storage=20 may require additional packaging to preserve containment of the = waste. This may be a rigid or = semi-rigid=20 container or double bagging.

m. = ; =20 Carts used to transfer wastes within a facility = should=20 be disinfected and cleaned frequently.

n. = ; =20 USDOT Regulated waste material to be transported = offsite, on public access roads (or otherwise enter commerce), for=20 decontamination shall be packaged, marked, labeled and shipped in = compliance=20 with USDOT hazardous materials regulations (49 CFR Parts171-180).

9. =20 MECHANICAL METHODS FOR DECONTAMINATION OF =20 BIOHAZARDOUS WASTE

The purpose of this = section is to=20 describe mechanical strategies used for decontaminating surfaces, items, = and=20 areas (laboratories, animal facilities, etc.). The basic goal of = decontamination=20 is to render an article safe for reuse or disposal. In order to eliminate the = potential for=20 environmental transmission of a biological agent under study/examination = to a=20 susceptible host, one or more of the requirements for environmental = transmission=20 must be disrupted. = Environmental=20 transmission can occur when the following requirements, also known as = the =93Chain=20 of Transmission,=94 include:

=B7 = ; =20 Presence=20 of agent

=B7 = ; =20 Sufficient virulence of=20 agent

=B7 = ; =20 High=20 numbers of agent

=B7 = ; =20 Mechanism of transmission from = environment to=20 host

=B7 = ; =20 Correct=20 portal of entry

=B7 = ; =20 Susceptible = host

a. =20 Mechanical decontamination involves measures to remove, but not=20 necessarily neutralize, an agent. =20 Cleaning is the removal of visible dirt and stains. This includes, but is not = limited=20 to:

(a) =20 brushing or vacuuming with a HEPA vacuum

(b) =20 washing or damp mopping with water containing a soap or = detergent

b. =20 Precleaning is routinely carried out if the risk of human or = animal=20 contact with pathogen-contaminated materials is high and subsequent=20 decontamination is needed. = In these=20 cases, precleaning is essential to achieve proper disinfection or = sterilization,=20 because dirt and soil can shield microorganisms and can also interfere = with the=20 killing action of chemical germicides. =20

c. =20 Many germicidal products are only effective on precleaned = items.

d. =20 Precleaning must be carried out carefully to avoid exposure to = infectious=20 agents.

e. =20 Precleaning should only be conducted with materials chemically = compatible=20 with the germicides that will be subsequently applied. Because of this, it is common = to use the=20 same chemical germicide for precleaning and disinfection.

10. = PHYSICAL=20 METHODS FOR DECONTAMINATION OF BIOHAZARDOUS WASTE

The purpose of this = section is to=20 describe physical strategies used for decontaminating surfaces, items, = and areas=20 (laboratories, animal facilities, etc.). The basic goal of = decontamination is to=20 render an article safe for reuse or disposal. In order to eliminate the = potential for=20 environmental transmission of a biological agent under study to a = susceptible=20 host, one or more of the requirements for environmental transmission = must be=20 disrupted. Physical = decontamination=20 renders the agent harmless through physical means, such as heat, = ionizing=20 radiation, and ultraviolet (UV) radiation.

a. =20 The most effective method of physical decontamination is steam=20 sterilization (autoclaving). = Steam=20 sterilization under pressure is universally used in the conduct of = biological=20 research except when steam penetration or heat and moisture damage is a = concern.=20 Steam sterilization is considered one of the most dependable systems = available=20 for decontaminating laboratory waste and sterilizing laboratory = glassware,=20 media, and reagents.

Autoclaves=20 are essentially steel pressure vessels that use pressurized steam, = usually 15=20 PSI (1.05=20 kg/cm2), to achieve a = chamber=20 temperature of at least 121=B0C (250=B0F), which is effective at = inactivating=20 microorganisms and proteinaceous bacterial and plant toxins.

The=20 critical factors in ensuring the reliability of this sterilization = method are=20 proper temperature and time and the complete replacement of the air with = steam=20 (i.e., no entrapment of air). =20 Because of these factors, chamber pressurization requirements = increase at=20 higher geographic elevations. =20

Some=20 autoclaves use a steam-activated exhaust valve that remains open during = the=20 replacement of air by live steam until the steam triggers the valve to=20 close. Others use a = pre-cycle=20 vacuum to remove air prior to steam introduction.

(1) = There=20 are three types of autoclave cycles:

(a) = The=20 gravity cycle is also known as the =93Fast Exhaust=94 cycle, and is = typically used=20 to decontaminate or sterilize dry goods, glassware, etc. During this cycle, the chamber = charges=20 with steam and holds it at a set temperature for a set time; at the end = of the=20 cycle, the chamber returns quickly to atmospheric pressures.

(b) = The=20 pre-vacuum cycle is used for decontaminating porous materials, animal = bedding,=20 etc.; in this process, the autoclave chamber is partially evacuated = before steam=20 is introduced, which facilitates steam penetration throughout the load. =

(c) = The=20 liquid cycle is also known as the =93Slow exhaust=94 cycle. Steam is exhausted slowly at = the end of=20 the cycle to prevent sterilized liquids from boiling over; in this = process,=20 liquid containers must not be overfilled before autoclaving, or they = will boil=20 over and represent a hazard to the operator.

(2) = The=20 following procedures must be followed when preparing to place = biohazardous=20 materials in an autoclave.

(a) =20 Materials that are to be decontaminated should be carried to the=20 autoclave in closed, leak proof containers. Primary containers used during = autoclaving include plastic autoclave bags, which are polypropylene bags = used to=20 contain materials during decontamination cycles within autoclaves. These = bags,=20 also known as "autoclavable bags", come in a wide variety of sizes, = shapes and=20 colors, and are available from many laboratory supply houses.

(b) =20 Autoclave bags are usually placed in polypropylene or stainless = steel=20 pans during decontamination cycles to catch liquids that may drain out = of the=20 bag.

=20 (c) =20 Autoclave bags should be closed loosely during decontamination to = allow=20 steam to penetrate into the bag. = It=20 is essential = for=20 steam to come in contact with all areas of the load, and steam = saturation is=20 required for maximum heat transfer; air pockets or = inadequate=20 steam supply will result in incomplete sterilization.

(d) = Water=20 should be added to the materials that will be decontaminated to = facilitate steam=20 contact, but it is necessary to guard against creating infectious = aerosols in=20 the process. For safe = handling,=20 operators should trickle water down the sides of the container, instead = of=20 pouring water directly onto the material in the container or bag. In any case, 250-500 ml of = water should=20 be added to the interior of the autoclave bag to facilitate heat = transfer to the=20 material being decontaminated, unless the addition of water might create = splashing that could facilitate the release of potentially infectious = material=20 from the bag.

(e) =20 Autoclave bags that are filled in a laboratory should be = temporarily=20 placed inside another leak proof and puncture resistant container, which = can=20 then be taken to the autoclave. The autoclave bag should be removed from = the=20 container, decontaminated in the autoclave and discarded into the = appropriate=20 waste container in accordance with all facility policies and State = and/or local=20 regulations.

1 =20 Secondary containers used during autoclaving can include plastic=20 containers and steel containers. =

2 =20 Polypropylene is a durable, inexpensive plastic resin that is = commonly=20 used to contain material during autoclaving. Polypropylene plastic pans = with 6-12=20 inch sides can withstand autoclaving without melting and are preferred = over=20 polyethylene and polystyrene pans. =20 When using polypropylene containers, extra processing time needs = to be=20 added to the autoclave decontamination cycle because polypropylene does = not=20 conduct heat as well as stainless steel.

3 =20 Stainless steel containers are durable and come in a variety of = sizes and=20 shapes, and may reduce autoclave decontamination cycle processing time = because=20 stainless steel is a good conductor of heat. Durable stainless steel = containers may=20 be the optimal containers for autoclave decontamination when waste = containment=20 is mandatory.

(3) = Only=20 adequately-trained personnel should be permitted to operate an = autoclave, and=20 laboratory/program supervisors are responsible for providing and = documenting=20 autoclave operator training. =

(a) =20 Appropriate personal protective equipment is required, including = a fully=20 fastened lab coat, heat resistant gloves, eye protection, etc., = particularly=20 when unloading the autoclave. = Local=20 or area Safety, Health, and Environment staff should be consulted on the = purchase of appropriate personal protective equipment.

(b) =20 Autoclave operators should routinely inspect the autoclave = components for=20 proper operation, including inspections of autoclave door clamps and = seals for=20 signs of wear and damage. =

(c) =20 Autoclave operators should ensure that debris from the autoclave = chamber=20 floor drain has been removed;=20 if the sieve is blocked with debris, a layer of air may form at the = bottom of=20 the autoclave, preventing sufficient heat transfer. If operators find a problem, = they should=20 promptly notify the laboratory/program supervisor who will facilitate = the repair=20 of the unit. A DAMAGED AUTOCLAVE MUST NOT BE = OPERATED=20 UNTIL IT HAS BEEN PROPERLY REPAIRED.

(4) =20 Processing times starts after the autoclave is loaded and started = and has=20 reached normal operating conditions of 121^oC = (250^oF) and=20 pressures of 15 psi. =

(a) =20 Decontamination conditions vary with load type, load volume = (loose packed=20 or tightly packed), container type (polypropylene, glass, stainless = steel), and=20 the type of material to be decontaminated. =20 Larger loads will typically require more time for complete=20 decontamination.

(b) = Sixty=20 minutes are needed to decontaminate lab and medical waste, unless a = shorter=20 interval has proven effective by testing with biological = indicators. Typically, additional time is = required=20 if polypropylene containers are used instead of stainless steel = containers.

(c) =20 Ninety minutes are recommended for the decontamination of waste = in low=20 sided polypropylene containers with bags half filled and loosely = gathered.

(d) = A=20 longer processing time (120 minutes or more) may be needed if bags are = tightly=20 packed and do not readily permit steam penetration throughout the = load.

(e) = If=20 the autoclave is equipped to operate at 132^oC = (270^oF), it=20 may be possible to reduce the processing time, if the shorter run times = are=20 validated using biological indicators. =20 Typically BIs are placed in the center of the load.

(f) =20 According to the EPA, "Infectious wastes from departments of = health care=20 facilities may be rendered noninfectious by subjecting the waste to = autoclave=20 temperatures of 121^oC (250^oF) and 15 minutes of = prevacuum=20 of 15 psi for the following dwell times when proper containers are = used:"

=20 EPA Recommended Decontamination Processing (Dwell) Times:

TRASH &nbs= p; = ; =20 60 Minutes

GLASSWARE =20 &nbs= p; =20 60 Minutes

LIQUIDS =20 &nbs= p; =20 60 Minutes / Gallon

ANIMAL CARCASSES 8 Hours

ANIMAL BEDDING =20 = 8=20 Hours

(5) = At=20 the end of a decontamination cycle, the operator must ensure that the = pressure=20 in the autoclave chamber is near zero before opening the door. Once this has been verified, = the=20 operator should slowly crack open the autoclave door (operator remaining = behind=20 the door) and allow the steam to gradually escape from within the = autoclave;=20 opening the autoclave door too quickly may result in glassware breakage = and/or=20 steam burns. After = materials inside=20 the autoclave have been allowed to cool for 15-30 minutes, they can = safely be=20 removed from the autoclave by the operator in conjunction with = appropriate=20 PPE.

(6) = Newer=20 autoclave models are equipped with an internal printer that records = temperature=20 and pressure at pre-determined intervals throughout the autoclave cycle = on a=20 receipt-tape. The = recorder tape=20 should be removed and taped into the autoclave logbook as a permanent = record of=20 autoclave performance.

b. =20 Ionizing Radiation is known as a cold sterilization process since = sterilization can be achieved at room temperature. There are two technologies = currently in=20 use; electron-beam (E-beam) technology or γ-irradiation. Regardless of the method used, = the=20 primary means of inactivating organisms is to disrupt DNA chains by = secondary=20 energetic species (e.g., free radicals, electrons). The typical dose required for=20 sterilization of bacterial spores is reported as 2.5 megarads.

(1) = ; =20 Gamma Irradiation: Gamma rays, emitted from = cobalt-60,=20 are similar in many ways to microwaves and Xrays. Ionizing energy produced by = gamma rays=20 penetrates deeply, making it a good fit for products with various = densities and=20 packaging types. Processing times=20 tend to be longer as compared to Ebeam technology.

(2) = ; =20 E-beam radiation: =20 a form of ionizing energy, is generally characterized by low = penetration=20 and high-dose rates. E-beam irradiation is similar to gamma processing = in that=20 it alters various chemical and molecular bonds on contact, including the = reproductive cells of microorganisms. Beams produced for e-beam = sterilization=20 are concentrated, highly-charged streams of electrons generated by the=20 acceleration and conversion of electricity. Typical medical device = sterilization=20 uses high-energy electrons, usually 10 million electron volts (10 MeV). = This=20 type of E-beam facility has a capacity comparable to a multimillion = curie=20 60cobalt facility. Electron penetration into a product directly = correlates to=20 the energy of the electron and the density of the material to be = sterilized.=20 In general, E-beam = irradiation=20 performs best on low density, uniformly packaged products.

c. =20 UV radiation is a form of non-ionizing radiation that has been = used as an=20 antimicrobial disinfectant for over 50 years, but its use as a surface = and air=20 disinfection method remains limited. =20 The inactivation of microorganisms from exposure to UV radiation = is=20 attributed to photobiochemical reactions that are induced within the=20 microorganism.

(1) =20 Germicidal lamps should have an output of least 40 microwatts per = Cm² at 254 nanometers, and should be monitored frequently to = ensure=20 appropriate output. UV = bulbs should=20 be cleaned frequently to prevent dust accumulation.

(2) =20 Cellular nucleic acids, DNA and RNA, particularly their = pyrimidine bases=20 are especially susceptible to UV radiation and its antimicrobial and = mutagenic=20 effects. UV induced = damage is=20 caused by the creation of nucleic acid dimers.

(3) =20 Proteins are also affected by UV radiation, but they are = typically less=20 sensitive and exhibit a more varied level of damage when compared to = nucleic=20 acids.

c. =20 Dry Heat/Incineration systems use high-temperature combustion to = burn=20 pathological and other medical wastes, and reduce the waste materials to = non-combustible ash. A = variety of=20 incinerators can be used to incinerate research waste, but controlled = air=20 incinerators are most commonly used. =20 Typically these incinerators have a dual chamber configuration = that=20 provides two sequential combustion processes, and a stack for venting = combustion=20 products/emissions.

(1) = For=20 effective incineration, the operator must ensure that the incinerator is = in=20 proper working order and that the incinerator is the proper type with a = valid=20 operation permit.

(2) =20 Pathological waste or other medical waste is loaded into the = primary or=20 lower chamber, where the combustion process begins in an environment = which has=20 less than the stoichiometric amount of air required for combustion.

(3) =20 Combustion air enters the primary chamber from beneath the = incinerator=20 hearth, below the burning bed of waste. =20 This air is called primary or underfire air. In the primary (starved-air) = chamber,=20 the low air-to-fuel ratio dries and facilitates volatilization of the = waste, and=20 most of the residual carbon in the ash burns. In these conditions, = combustion gas=20 temperatures are a relatively low 760^o to 980=B0C = (1,400^o to=20 1,800=B0F).

(4) = In=20 the second stage, excess air is added to the volatile gases formed in = the=20 primary chamber, which completes the combustion. Secondary chamber temperatures = are higher=20 than primary chamber temperatures--typically 980^o to = 1,095=B0C=20 (1,800^o to 2,000=B0F), and sterilization of any remaining = infectious=20 particulates will occur within this chamber.

(5) = Most=20 modern incinerators include a scrubbing system or other pollution = control=20 systems after the secondary chamber to remove particulates and acid = gases.

d. = ; =20 Alkaline = hydrolysis is a=20 process by which complex molecules are broken down into their = constituent=20 building blocks by the insertion of ions of water (H₂O), H+, = and=20 OH- between=20 the atoms of the bonds that held those building bocks together. The = process=20 occurs in nature when animal tissues and carcasses are buried in soil of = neutral=20 or alkaline pH and in our small intestines after we = eat.

Alkaline = hydrolysis can=20 also be used for disposing of waste biologic tissues and animal = carcasses by=20 subjecting the waste to strong alkali and heat under pressure. Alkali, in the form of = either=20 sodium or potassium hydroxide solution, or a mixture of both, is used at = temperatures ranging from ~100=83C to 180=83C and higher for rapid = dissolution and=20 then hydrolysis of the proteins into small peptides and amino acids in = the form=20 of their sodium or potassium salts. Potassium hydroxide or mixtures of = potassium=20 hydroxide and sodium hydroxide are the preferred alkali solutions = because of the=20 instability of concentrated (50%) stock solutions of NaOH solutions at=20 temperatures below 20=83C . =20 The result=20 is a sterile liquid with high biological and chemical oxygen demand, and = a=20 crumbly, sterile solid resembling bone.

11. = CHEMICAL=20 METHODS FOR DECONTAMINATION OF BIOHAZARDOUS WASTE

The purpose of this = section is to=20 review the various chemical methods used for decontaminating = biohazardous wastes=20 or potentially contaminated surfaces. =20 Chemical decontamination renders the agent harmless through the = use of=20 antimicrobial disinfectants or sterilants. =20 Current technologies for chemical (antimicrobial) decontamination = fall=20 into three categories: liquids, foams and gels, and gases and = vapors. Liquids are effective against = many=20 biological agents when applied to hard, nonporous surfaces, but they can = cause=20 corrosion to sensitive materials. Foams and gels are effective against = certain=20 biological contaminants, but some can pose a post-decontamination = cleanup issue.=20 Gases and vapor fumigants = are=20 effective for inactivating biological agents under controlled = environments and=20 conditions, but they involve complex, time-consuming, and expensive = operations.=20 Gases offer advantages in = decontamination, but the quantities of certain gases required for = room/area=20 decontamination can create inherent safety hazards.

&nbs= p; = ; =20

Chemical disinfectants = are regulated=20 by the EPA under the Federal=20 Insecticide, Fungicide, and Rodenticide Act (FIFRA) and assigned = to the=20 following categories:

=B7 = ; =20 Sterilizer or Sterilant - will destroy = all=20 microorganisms, including bacterial and fungal spores, on inanimate = surfaces.=20

=B7 = ; =20 Disinfectant - will destroy or = irreversibly=20 inactivate specific viruses, bacteria, and pathogenic fungi, but not = bacterial=20 spores.

=B7 = ; =20 Hospital Disinfectant - shown to be = effective=20 against S. aureus, S. choleresis and P. aeruginosa. It may be effective against M. tuberculosis, pathogenic = fungi or=20 other viruses.

=B7 = ; =20 Antiseptic - formulated for use on skin = or=20 tissue, and does not act as a disinfectant.

a. =20 In 1972 Dr. Earl Spaulding classified chemical germicides by = levels=20 of disinfection (High, Intermediate and Low). Material Safety Data Sheets,=20 Manufacturer Label Instructions & Claims and other manufacturer=92s = product=20 information should be available and thoroughly reviewed before using = these=20 products to ensure appropriate and safe application.

=20

(1) = High-level disinfection = kills=20 vegetative microorganisms and inactivates viruses, but may not kill = high=20 numbers of bacterial spores. = These=20 disinfectants typically are capable of sterilization when the contact = time is=20 relatively long (e.g., 6 to 10 hours). As high-level disinfectants, = they are=20 used for relatively short periods of time (e.g.,, 10 to 30 = minutes). In some cases these chemical = germicides=20 are potent sporicides that are classified by the Food and Drug = Administration=20 (FDA) as sterilants/disinfectants. They are formulated for use on = medical=20 devices, but not on environmental surfaces such as laboratory benches or = floors.

(2) =20 Intermediate-level disinfection kills vegetative=20 microorganisms, including Mycobacterium tuberculosis and all = fungi,=20 and inactivates most viruses. Chemical germicides used in = this procedure often correspond = to=20 EPA-approved "hospital = disinfectants" that are also "tuberculocidal." They are used commonly in = laboratories to disinfect laboratory benches, and are part of the = inventory of=20 detergent germicides used for housekeeping.

(3) =20 Low-level disinfection kills most vegetative bacteria = (except=20 M. tuberculosis), some=20 fungi, and inactivates = some=20 viruses. The EPA approves = chemical=20 germicides used in this=20 procedure in the United States as "hospital=20 disinfectants" or "sanitizers."

b. =20 Common laboratory disinfectants include alcohols, aldeyhdes, = chlorine=20 compounds, iodine and iodophors, phenol and phenolic compounds, and = quaternary=20 ammoninum compounds

(1) =20 Alcohols possess many desirable attributes for use as = disinfectants or=20 antimicrobials. Many = alcohols have=20 a cleansing action and have no residual effects, which can be = advantageous in=20 some applications. Their = specific=20 activity depends on concentration levels and disinfection = conditions. Like many chemical = disinfectants, the=20 effectiveness of alcohol as a non-specific antimicrobial disinfectant = stems from=20 a range of combined toxic mechanisms, but its primary mode of action is = through=20 protein coagulation/denaturation. =20

(a) =20 Alcohols are bactericidal as well as bacteriostatic against = vegetative=20 forms, and are also effective against fungi and lipid viruses, but are = only=20 moderately effective against nonlipid viruses, and are completely = ineffective=20 against bacterial spores.

(b) = The=20 most commonly used alcohols, ethanol and isopropanol, are most effective = at=20 concentrations of 70% in = water;=20 higher and lower concentrations are less effective because proteins are = not=20 denatured as readily in the absence of water, so alcohol solutions above = 85% are=20 ineffective for disinfection purposes. =20

(c) =20 Alcohols are not recommended for use as a surface contact = disinfectant=20 because they evaporate quickly, which decreases contact time and impedes = their=20 penetration of organic matter. =

(d) = When=20 disinfecting with alcohols, it is best to clean an object and then = submerge it=20 in alcohol for the recommended contact time.

(e) =20 Because the most commonly used alcohols (methanol, ethanol, = propanols,=20 propanols and tert-butanol) have flashpoints lower than 15^oC=20 (59^oF), proper precautions are essential when they are used = as=20 disinfectants; for instance, alcohols should never be used around a = Bunsen=20 burner or other open flame. =

(2) =20 Aldehydes=97including formaldehyde in its gas state and = glutaraldehyde=20 in its liquid state=97are both good disinfectants. However, aldehydes are toxic, = and their=20 practical use in the laboratory for routine disinfection is = limited.

(a) =20 Aldehydes are active against vegetative bacteria (including=20 mycobacteria), spores, fungi, and both enveloped and nonenveloped = viruses. They remain active in the = presence of=20 protein, and their activity levels are only lessened slightly by natural = or=20 man-materials or detergents.

(b) =20 Formaldehyde is available as a gas dissolved in a mixture of = water and=20 methanol, and as a 37% formaldehyde solution known as formalin. Dissolved in water, = formaldehyde is=20 active at 1-8% solutions, and can be used to decontaminate hard = surfaces. However, formaldehyde is very = irritating=20 at low concentrations (0.1 to 5 ppm), and is classified as a probable=20 carcinogen, so it is used only when necessary to disinfect hard = surfaces.

(c) =20 Gluteraldehyde is usually supplied as a 20% solution and requires = activation by the addition of an alkaline agent prior to use. The activated product may be = kept for=20 about two weeks and should be discarded when turbid. Glutaraldehyde is toxic, = irritating, and=20 mutagenic, and should be used only when necessary (i.e., for the = decontamination=20 of endoscopes). It is = essential to=20 follow the manufacturer=92s guidance/label claims when using = glutaraldehyde-based=20 products, because there are many different formulations that have been = designed=20 for specific uses.

(3) =20 Chlorine compounds: The most=20 commonly used and generally effective chlorine based disinfectant is = sodium=20 hypochlorite (common household bleach). It is a strong oxidizing agent = and=20 therefore can be corrosive to metal. The presence of high concentrations = of=20 protein or other organic material can reduce the effectiveness of = chlorine=20 products, and dilute hypochlorite solution should be prepared daily to = be=20 maximally effective. = There are more=20 concentrated sodium hypochlorite solutions available for industrial use, = and=20 product information must be followed carefully to determine the proper=20 dilution.

(a) = A=20 1:50 dilution = of 5.25%=20 Sodium hypochlorite(e.g., Clorox^=AE household bleach) with water, supplying 1000 = ppm=20 available chlorine is very effective as a general laboratory = disinfectant.

(b) = A=20 1:10 dilution = supplying=20 5000 ppm available chlorine is effective against spills involving blood = or other=20 organic material.

(4) =20 Iodine and iodophors are compounds in which the iodine is = combined=20 with a solubilizing or carrier agent. =20 They serve as all-purpose disinfectants and have an action = similar to=20 that of chlorine products. Like chlorine compounds, the effectiveness of = iodine=20 compounds may be diminished in the presence of protein.

(a) = The=20 appropriate concentration for iodine-containing products to disinfect = work=20 surfaces is 75 ppm available iodine. =20 Concentrations may be much higher for other purposes.

(b) = Only=20 those iodophors registered with EPA as hard-surface disinfectants should = be=20 used, and the manufacturer's instructions regarding proper dilution and = product=20 stability must be closely followed. =20

(c) =20 Antiseptic iodophors are not suitable for disinfecting devices,=20 environmental surfaces, or medical instruments.

(5) =20 Phenolic compounds are active at concentrations of 0.2% to 3% = against all=20 forms of vegetative microorganisms, but are not active against spores, = and have=20 only limited effectiveness against nonlipid viruses. Most phenolics are active in = the presence=20 of large amounts of protein, but are inactivated to some extent by = rubber, wood,=20 and plastics. They are not compatible with cationic detergents. In the laboratory, they can be = used to=20 disinfect discard jars and surfaces. =20 Many common disinfectants are based on phenol and should be used=20 according to the manufacturer=92s recommendations.

(a) = Clear=20 phenolics should be used at the highest recommended concentration.

(b) =20 Dilutions should be prepared daily and diluted. Phenolics should = not be=20 stored for more than 24 hours. =

(6) =20 Quaternary ammoninum compounds are cationic detergents, = active at=20 concentrations of 0.1% - 2%, which are effective against vegetative = bacteria,=20 enveloped viruses, and some fungi. They are less or not effective = at=20 inactivating mycobacteria, spores, and non-enveloped viruses, and are=20 inactivated by protein and a variety of natural and plastic materials = and soap.=20 Because of this, their = laboratory=20 uses are limited; however, they are stable compounds and are = non-corrosive to=20 metals. They are usually = used for=20 cleaning surfaces and are used extensively in food hygiene laboratories = because=20 of their detergent nature. They are non-toxic and harmless to the skin = and=20 eyes.

c. =20 Only a few gas and vapor chemical sterilants are widely used in=20 biomedical and research institutions, and for other industrial = sterilization=20 applications. Gaseous = sterilants=20 can be broadly characterized by an alkylation or oxidizing mode of = action, and=20 gas/vapor sterilization is only achieved through the successful union of = the=20 sterilant and the sterilization process. =20 Many of the gas/vapor methods have a fundamental process sequence = of=20 pre-conditioning (temperature, relative humidity, sterilant = concentration etc),=20 exposure, and sterilant removal.

(1) = Only=20 individuals who are well versed and well trained on the sterilization = method,=20 sterilant, and associated hazards should be permitted to conduct=20 decontamination/sterilization operations using these agents. Certain gas-phase water = disinfection=20 systems involve the generation of gas onsite, using chemical or = electrochemical=20 processes that offer some advantages in terms of removing the = requirement for=20 the storage of compressed gases. =

=20

(2) =20 Difficulties with some of these systems include measuring the = efficiency=20 of the gas-producing reaction, and establishing that the required = contact time=20 and concentration gradients are achieved.

(3) =20 Chlorine dioxide (CD), a greenish-yellow gas, is an effective = sterilant=20 and powerful oxidizer even at low concentrations of 10=9620 mg/L. The = EPA=20 registered CD under the FIFRA as a sterilizing agent in 1988. CD reacts = with=20 carbohydrates by oxidizing the primary hydroxyl groups to aldehydes and = then to=20 carboxylic acids. Oxidation occurs at the double bond with lipids. The = effect on=20 peptides and proteins is mainly oxidation, substitution, and addition = reactions.=20

(a) = The=20 lethal activity of CD on spores is dependent on hydration of the spores = for=20 optimal activity=97a relative humidity of 50% or higher is optimal for=20 sterilization.

(b) = CD is=20 noncarcinogenic, nonflammable, does not deplete ozone, and is not = associated=20 with any serious human toxicity from either acute or chronic = ingestion.

(c) = CD is=20 considered a mucous membrane irritant and inhalation of excessive = amounts can=20 result in pulmonary edema. The threshold limit value time-weighted = average (the=20 period of safe exposure during an 8-hour period) for CD is 0.1 parts per = million, which is also the reported odor threshold.

(d) = After=20 an area is treated, CD can be converted to sodium sulfate using sodium=20 thiosulfate.

(e) =20 Because of the selective reactivity of CD, materials such as = titanium,=20 stainless steel, silicone rubber, ceramics, polyvinyl chloride, and = polyethylene=20 are unaffected by exposure to the gas. However, uncoated copper and = aluminum are=20 highly affected. In = addition,=20 certain formulations of polycarbonates and polyurethanes develop a = marked change=20 in color and tensile properties. =

(4) =20 Ethylene oxide (epoxyethane, ETO) is one of the most widely used=20 alkylating sterilants by the research and biomedical communities. It is a flammable and = explosive gas, and=20 is classified as both a mutagen and a carcinogen. The microbicidal = activity of=20 ETO is caused by alkylation of sulfhydryl, amino, carboxy, phenolic, and = hydroxyl groups in the spore or vegetative cell. The primary mechanism = of its=20 bactericidal and sporicidal activity is the reaction of ETO with nucleic = acids.=20 ETO is used because of its ability to inactivate most bacteria, molds, = yeasts,=20 and viruses, but its use is limited because of the many dangers = mentioned. An EPA air permit is required = to use ETO=20 under certain circumstances because of air quality emission = standards. ETO sterilization should only = be=20 conducted in strict compliance with the sterilizer manufacturer=92s = operating=20 guidelines.

(a) = Four=20 parameters affect the ability of ETO to sterilize products: temperature, concentration, = humidity and=20 time. =20

1 =20 Most routine sterilization is conducted at 49^o to=20 60^oC (120^o to 140^oF), but = sterilization of=20 particularly heat sensitive materials is performed at 38^o to=20 40^oC (100^o to 105^o).

2 =20 It has been determined that 450 mg/liter is the minimum ETO = concentration=20 required to achieve sterilization, but most ETO sterilizers use ETO=20 concentrations of 600 -1,100 mg/liter. =20

3 =20 A relative humidity of 45-75% must be maintained to achieve=20 sterilization.

4 =20 The amount of time required for sterilization is temperature = dependent,=20 taking less than 2 hours at 54^oC (130^oF) and over = 5 hours=20 at 38^oC (100^oF).

5 =20 Since ETO penetrates into porous material and is absorbed = strongly by=20 rubber and many plastics, an appropriate aeration time is required; in = most=20 cases aeration times of 12 hours or more are utilized.

(5) =20 Formaldehyde is widely used by the research and biomedical = communities as=20 a fumigant for buildings, rooms, and equipment, and has commonly been = used as a=20 gas/vapor decontaminant for enclosed areas. Formaldehyde acts as a = decontaminant by=20 denaturing proteins. It = is capable=20 of killing microorganisms and detoxifying C. botulinum toxin, but is not = effective=20 at inactivating prions, and a formaldehyde concentration of 0.6 g/ft3 is = required to kill the rikettsial agent Coxeilla burnetii, the = causative agent=20 for Q fever. &nbs= p; =20 &nbs= p; =20

(a) =20 Ammonium carbonate/bicarbonate can be used to neutralize = formaldehyde=20 gas.

(b) =20 Although formaldehyde vapor is explosive at concentrations = between 7.0=20 and 73.0% by volume in air, these concentrations should not be reached = if=20 standard decontamination procedures (using 0.3=960.6 g/ft3 of = paraformaldehyde in=20 the presence of 60=9690% relative humidity with a minimum contact time = of 6 hours)=20 are used.

(c) =20 Although widely used and recommended as a surface and area = sterilant,=20 formaldehyde is a safety hazard because it is a carcinogen.

(d) =20 Formaldehyde is also a powerful reducing agent, has limited = penetrating=20 ability, and is potentially explosive. Environmental release of = formaldehyde is=20 also highly regulated.

(e) = Until 1991, paraformaldehyde = was=20 registered for = decontamination of=20 laboratories and experimental animal facilities. However, all = registrations for=20 this use and many of the other uses described above were canceled due to = nonpayment of registration maintenance fees by the manufacturer. Currently only those = facilities that=20 have applied and received a quarantine exemption from EPA can use=20 paraformaldehyde for laboratory disinfection.

(6) = Vapor=20 Phase Hydrogen Peroxide (VPHP) has been emerging as a viable alternative = for=20 sterilizing biomedical devices and for some industrial = applications. Because of its low toxicity, = VPHP can=20 provide rapid, low-temperature decontamination that is less hazardous to = workers=20 compared to most of the other decontaminants discussed in this = section. VPHP can be utilized to = decontaminate or=20 sterilize items and equipment that cannot withstand the higher = temperatures=20 required in steam sterilization and dry heat. The hydroxyl radical, a = strong=20 oxidant, is believed to have microbicidal activity by attacking membrane = lipids,=20 DNA, and other essential cell components. The hydrogen peroxide vapor is = unstable and degrades through a catalytic process to the nontoxic = residues of=20 water vapor and oxygen. =

(a) = In=20 this cold sterilization process, 35% liquid hydrogen peroxide (300,000 = ppm) is=20 vaporized to yield 700=961200 ppm.

(b) = Small=20 rooms, biological safety cabinets, or other small enclosures (up to 7500 = ft³) that can be effectively sealed can be sterilized with = existing=20 portable equipment.

(c) =20 Non-portable generating equipment that can decontaminate larger = spaces is=20 available, but the initial purchase of one of these systems can be = costly.

(7) =20 Propylene oxide (epoxy propane) is an alkylating agent that is = widely=20 used for industrial applications such as the deinfestation and = sterilization of=20 agricultural products, including spices, nuts, and other food = products. Propylene oxide hydrolyzes in = the=20 presence of moisture to form nontoxic propylene glycol. Propylene glycol vapor is = odorless,=20 tasteless, and nonirritating to the respiratory mucosa. The microbicidal = mode of=20 action of propylene oxide is the alkylation of DNA guanines, which = results in=20 single-strand breaks. β-propiolactone (BPL) is approximately 4000 = times more=20 active than ETO and 25 times more effective than formaldehyde. The=20 microbiological activity of BPL is caused by alkylation of DNA.

(a) =20 Although propylene oxide is similar in activity to ETO and uses = similar=20 equipment and cycles, use of this decontaminant is limited because BPL = lacks the=20 ability to penetrate material, requires a longer processing time, and is = carcinogenic in mice.

(8) =20 Methyl Bromide is a broad spectrum fumigant used to control = insects,=20 weeds, rodents, and pathogens. A=20 colorless and odorless gas at room temperature, methyl bromide is = normally=20 applied as a liquid under pressure that vaporizes upon release at the = point of=20 application. Methyl = bromide is=20 produced by direct bromination of methane and by the hydrobromination of = methanol. In the = United=20 States, methyl bromide is used = primarily as a=20 soil fumigant, but it can also be used as a disinfectant, rodenticide,=20 methylating agent, wool degreaser, and in ionization chambers. Methyl bromide is applied into = loose=20 soil under plastic sheets or used in space fumigation under tarpaulins, = and is=20 also applied to a variety of agricultural commodities in specially = designed=20 fumigation chambers.

(a) =20 Worker exposure may result from leaks in the plastic sheets or = the=20 tarpaulin, or from failure to allow adequate time for the methyl bromide = to=20 dissipate following fumigation.

(b) = The=20 use of methyl bromide as a pesticide is currently being phased out in = the United=20 States and all other countries, because of significant scientific = evidence that=20 using methyl bromide contributes to the destruction of the ozone layer. =

(c) = The=20 use of methyl bromide was completely phased out in 2005, with the = exception of=20 certain preshipment and quarantine uses, and other critical uses where = no other=20 technically or economically feasible alternatives are available.

12. =20 BIOHAZARDOUS WASTE DECONTAMINATION PROCESS VALIDATION

Validation of the decontamination process ensures that = agents of=20 potential harm to human, animal or plant health will be killed or = inactivated=20 prior to disposal or release into the environment. Written procedures are needed = to document=20 process validation, provide proof of compliance with relevant = performance=20 standards, and ensure ongoing process performance. Each decontamination process = should be=20 appropriately validated for the agent(s) to be treated, regardless of = the type=20 of process.

a. =20 Equipment calibration, maintenance and process validation

(1) = = Autoclaves=20 are a common means of decontamination in USDA facilities. Validation of=20 effectiveness includes monitoring temperature, pressure and cycle = duration time=20 for each cycle and providing periodic decontamination challenges = (quality=20 assurance), i.e., use of biological indicators.

(a) =20 Autoclaves performance must be verified prior to initial use and=20 maintained to assure that the temperature sensing system is accurate, = uniform=20 and stable. Annual rechecks/validation of operation is required.

(b) =20 Validation of autoclave temperature and pressure using = thermocouples=20 placed in various locations of the autoclave chamber should be performed = annually to assess the temperature uniformity and gauge accuracy. Perform verifications for = temperature and=20 time daily using appropriate chemical indicators.

(c) =20 Routinely conduct sterility validations using biological = indicators=20 (i.e., spore vials or strips). = Use=20 a microorganism that has a proven resistance to steam sterilization, = such as Geobacillus=20 stearothermophillus. =20 Validation frequency should be determined by autoclave usage and = load=20 types; weekly or bimonthly for each load type is typically = preferred.

(d) = Some=20 laboratories may choose to conduct more frequent autoclave = monitoring/validation=20 using biological and chemical indicators.

(e) =20 Laboratory/research programs that use a particular autoclave = should=20 maintain a logbook to record autoclave usage. The logbook should be = available for=20 inspection by USDA safety representatives and other authorities. The log should contain the = following=20 information:

=B7 = ; =20 date of treatment

=B7 = ; =20 quantity and type of waste autoclaved

=B7 = ; =20 method/condition of treatment

=B7 = ; =20 name of autoclave operator

(f) =20 Quality assurance for autoclaves also includes:

&nbs= p; = ; = =20

1 =20 ensuring that the appropriate containers are being selected for = the waste=20 that is being decontaminated

2 =20 providing odor control when necessary

3 =20 providing personnel training for the operation of an autoclave =

=20

(2) = Hot=20 air sterilizing ovens, other heat sterilizing equipment and rendering = processes=20 should be validated for intended use. =20 The same general principles involved with autoclave process = validation=20 can be used with these types of equipment as well.

(3) =20 Incineration processes used for burning medical and veterinary=20 pathological waste ensure that most biological agents do not survive the = process. Risk assessments = should be=20 done to ensure that the type of incineration process selected meets = acceptable=20 criteria for the target agent:

(4) = Vapor=20 and gas systems should be calibrated and the process validated before = use. The=20 validation should include verification of efficacy and uniformity across = the=20 area to be treated (room or chamber). =20 Annual performance checks should be performed. Each run should = monitor=20 the relevant parameters (Temperature, Relative Humidity, Vapor/Gas=20 concentration) and verified for effectiveness using biological = indicators,=20 recommended by the equipment manufacturer. Biological indicators should = be=20 utilized to verify the effectiveness of ethylene oxide, formaldehyde (Bacillus atrophaeus and/or Geobacillus = stearothermophillus=20 ), or vaporized Hydrogen Peroxide processes (Geobacillus=20 stearothermophillus).

(5) = Ionizing=20 Radiation treatment. = Should be=20 validated using the = biological=20 indicator, Bacillus = pumilus. The appropriate load size = must be = considered to=20 assure that radiation penetration is achieved. =20 Penetration is dependant on the technology used (i. e., Gamma = radiation or E Beam) and size, volume = and=20 density of the load.

(6) = Alkaline=20 Hydrolysis. This method = used=20 primarily for carcass disposal/decontamination may utilize a similar = validation=20 process to steam sterilization. =20 Each run should monitor the relevant parameters such as time,=20 temperature, pressure, and alkalinity. =20 In many cases Standard biological indicators used for steam = sterilization=20 could be used. The = process results=20 in the formation of an alkaline (pH 10.3-11.5) aqueous residue with a = high BOD=20 (biological oxygen demand, 50.000-75.000 mg/l) and a higher COD = (chemical oxygen=20 demand, up to 100.000 mg/l).

(7) =20 Chemical Disinfectants. =20 EPA and the = states (usually=20 that state's agriculture office) register or license pesticides for use = in the=20 United=20 States. EPA receives its authority to = register=20 pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act = (FIFRA). More than = 5000=20 antimicrobial products are currently registered with the U.S. = Environmental=20 Protection Agency (EPA) and sold in the marketplace. Nearly 60% of = antimicrobial=20 products are registered to control infectious microorganisms in = hospitals and=20 other health care environments.=20 Additional guidance needed for antimicrobials can be found in = the links=20 for efficacy test guidelines, antimicrobial policy questions, and other=20 antimicrobial guidance. See specific antimicrobial laws and guidance = documents=20 below:

=20

(a) =20 Registration Policy Documents - list of policy and guidance = documents to=20 assist in registering or understanding antimicrobial products=20 (http://www.epa.gov/oppad001/regpolicy.htm

(b) =20 Disinfectant Technical Science Section (DIS/TSS) Documents - for=20 determining efficacy data requirements, label claims, and in some cases = testing=20 requirements (http://www.epa.gov/oppad001/sciencepolicy.htm=20 )

=20 b. =20 Chemical process validation indicators

(1) =20 Chemical color change indicators for steam autoclaves change = color after=20 being exposed to normal autoclave operating temperatures of = 121^oC=20 (250^oF) for a few minutes, and provide a quick visual = reference for=20 heat penetration inside the load. =20 Chemical indicators should be positioned near the center of each = load,=20 and toward the bottom front of the autoclave. Most chemical indicators can = only be=20 used to verify that the autoclave has reached normal operating = temperature for=20 decontamination, 121^oC (250^oF). Chemical indicators alone are = not=20 designed or intended to prove that organisms are actually killed during = a=20 decontamination cycle.

Chemical indicators are = manufactured=20 by many companies and come in a wide variety of sizes, shapes, and = colors. They can be purchased from the = manufacturers of sterilization equipment, biosafety suppliers and lab = supply=20 distributors. In addition to chemical indicators for steam = sterilization, a=20 variety of chemical indicators (color change) are available to monitor = other=20 decontamination processes, such as vaporized Hydrogen Peroxide, = formaldehyde,=20 etc. These indicators = will verify=20 exposure/concentration of decontaminating agent(s); however additional=20 indicators should also be employed to verify the effectiveness of the=20 process.

(2) = Tape=20 indicators are adhesive backed paper tape with heat sensitive, chemical=20 indicator markings. = Commonly used=20 heat sensitive markings include diagonal stripes (autoclave tape), = and/or the=20 word "sterile." These = markings only=20 appear when the tape has been exposed to normal autoclave = decontamination=20 temperatures. Tape = indicators can=20 only be used to verify that the autoclave is reaching normal operating=20 temperatures for decontamination, 121^oC (250^oF); = they have=20 no time factor. Tape = indicators=20 alone are not designed or intended to prove that organisms have actually = been=20 killed.

=20 Tape indicators should be used on all material decontaminated by=20 autoclaving to show that the material has been processed. A three to four inch length of = autoclave=20 tape placed on the outside of the autoclave pan, bag, or individual = container is=20 sufficient for visual inspection by the operator.

c. =20 Biological process indicators =20

Biological indicator = systems are=20 designed to demonstrate that a decontamination method is capable of = killing=20 microorganisms that have shown resistance to that particular = method. For example Geobacillus stearothermophilus = spores=20 have typically been used to monitor the effectiveness of steam = sterilization=20 equipment (autoclaves). =

Typical biological = indicator=20 systems used to validate steam sterilization consist of a vial with = spore strips=20 or a small glass ampoule of growth medium with spores and indicator = dye. The manufacturers' = instructions for use=20 must be followed when using biological indicators for validations.

d. =20 Physical indicators of process validation should be included in = the=20 protocols to validate sterilization processes. These include:

=B7 = ; =20 thermocouples

=B7 = ; =20 maximum registry thermometers

=B7 = ; =20 temperature recorders, and

=B7 = ; =20 time-temperature sensors and = software.

e. =20 Quality controls for sterilization process validation include the = following:

(1) = Each=20 run or process should be traceable back to equipment or process by date, = time,=20 operator, and run identifier. = This=20 provides verification that each run was performed with equipment that = was=20 properly calibrated and maintained. =20

(2) = Data=20 should be maintained to ensure the effective verification of each = process.

(3) =20 Working thermometers, thermocouples or other equipment used for=20 calibrations and verifications of decontamination/sterilization process = should=20 be calibrated traceable to recognized national or international = calibration=20 units against a national or international reference thermometer.

(4) =20 Environmental monitoring of equipment or work areas by swabbing = the work=20 areas and testing for the analyte(s) or contaminant of interest will = ensure that=20 treatments are effective.

(5) =20 Equipment maintenance records and run logs should be maintained = to=20 document maintenance, malfunctions and routine use.

(6) =20 Documentation of run or load information and effectiveness of = treatments=20 should be maintained. Records=20 should be retained according to Federal, State and local regulation or=20 requirements, as well as facility or program requirements.

13. = USDA=20 PROCEDURES FOR PROTECTING EMPLOYEES FROM BIOHAZARDOUS WASTE

Biohazardous waste operations can be divided into = four=20 major categories: generation, packaging, transport, and disposal. = Supervisors=20 should perform a Job Hazard Analysis of all new tasks or new biohazard=20 associated with biohazardous waste related operations to assess whether = these=20 tasks can be safely executed by new or existing employees. The Job Hazard Analysis should = be=20 performed in accordance with guidance provided by OSHA at www.osha.gov,=20 including Bulletin 3071, Job Hazard Analysis. A Job Hazard Analysis = identifies=20 high-risk tasks, analyzes the tasks to identify hazards, and determines = methods=20 to control the hazards. =20

Biological Risk Assessment is similar to Job = Hazard=20 Analysis, but is focused on biological hazards. Section II, =93Biological Risk = Assessment,=94 in the=20 5^th edition of Biosafety in=20 Microbiological and Biomedical Laboratories (BMBL) outlines an approach for = conducting a=20 biological risk assessment, which includes:

=B7 = ; =20 identifying = agent=20 hazards

=B7 = ; =20 identifying = lab=20 procedure hazards

=B7 = ; =20 determining=20 appropriate biosafety levels

=B7 = ; =20 evaluating = staff=20 safety proficiency

=B7 = ; =20 reviewing = the risk=20 assessment with subject matter experts as appropriate.

The BMBL should be referenced for complete = details http://www.= cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.=20 The following table is a = sample Job=20 Hazard Analysis format that can be used to assess all the risks of a = task before=20 initiation.

Job Hazard Analysis Format = Table

3D"Job

a. =20 Biohazardous waste generation. =20 Generation of biohazardous waste may result from a number of = activities,=20 including but not limited to animal necropsy, potentially-infectious = sample=20 collection, sample preparation, sample analysis, animal waste = collection,=20 infectious article collection (e.g., contaminated laundry), infectious = waste=20 receptacle collection (e.g., waste sharps containers), spill clean-up, = and=20 mechanical equipment operation. =20

b. =20 Biohazardous waste packaging. =20 Once biohazardous waste is generated, it may need to be packaged = or=20 otherwise contained in preparation for disposal. The packaging process may = involve a=20 number of activities, including but not limited to moving, containing, = packaging=20 and/or decontamination/disinfection of biohazardous waste/waste = containers, and=20 cleaning up spills.

(1) = If=20 the disposal/treatment unit is located within the containment area, = little or no=20 packaging may be required. =20

(2) = If=20 the disposal/treatment unit is located outside the containment area = (whether=20 onsite or offsite), the waste will need to be packaged (if small = articles) or=20 contained (if liquid or bulk solid materials) in accordance with Section = 15 -=20 Security.

(3) = The=20 exterior of the package or container will then need to be disinfected = prior to=20 removal from the containment area using a disinfectant appropriate for = the=20 biological agent(s). =20

c. =20 Biohazardous waste transport. =20 Whether the biohazardous waste is to be disposed onsite or = offsite, the=20 waste will need to be taken to a treatment site. The activities associated with = transport=20 include, but are not limited to, collecting biohazardous waste = containers and/or=20 articles, placing the waste/waste containers/biohazardous articles in = vehicles,=20 driving transport vehicles, pushing hand carts, guiding self-propelled=20 equipment, cleaning up spills, decontaminating items, and unloading = waste/waste=20 containers/biohazardous articles into disposal = units.

(1) = The=20 treatment site may be a nearby autoclave within the work area, and = transport may=20 simply involve transporting the leak proof, sharp resistant waste = container to=20 the decontamination/treatment unit for processing.

(2) = If=20 the disposal unit is located outside the work area or laboratory, = whether onsite=20 or offsite, the packaged or contained waste will need to be transported = in a=20 secure manner to avoid releasing the biological agent(s) to the=20 environment. Check with = federal,=20 state and local requirements applicable to waste packaging or containers = for=20 transport. =

d. =20 When biohazardous waste is delivered to the disposal site, the = waste may=20 be staged temporarily prior to processing. =20

(1) = If=20 the disposal site is offsite, and the waste is transported in relatively = small=20 packages or containers which are sealed and disinfected, then temporary = staging=20 should pose few risks as long as the staging site is secured.=20

(2) = In=20 some cases, as with necropsy or pathological waste, the material may = need to be=20 placed in controlled environments (cold/freezer rooms or refrigerators) = prior to=20 decontamination and final disposal.

(3) = If=20 the packages or containers are unsealed in the staging area, the area = must meet=20 appropriate biocontainment standards according to the risk and planned=20 manipulations, and disposal unit operators must use appropriate = practices and=20 protective equipment. =20

e. =20 Biohazardous waste disposal. =20 Tasks associated with biohazardous waste disposal may include, = but are=20 not limited to, moving waste items, loading waste items into treatment = units,=20 using heavy equipment or forklifts, operating disposal units, = disinfecting=20 premises and equipment, disposing of treatment by-products and sampling = media,=20 and cleaning up spills.

(1) = The=20 disposal process will pose few risks if the packages or containers are = disposed=20 of with the waste and the seals remain unbroken, assuming the disposal = process=20 meets biocontainment standards.

(2) = If=20 the packages or containers are unsealed prior to disposal, then the = disposal=20 facility must meet appropriate biocontainment standards according to the = risk=20 and planned manipulations, and disposal unit operators must use = appropriate=20 practices and protective equipment. =20

=20 f. =20 Physical hazards of biohazardous waste = operations:

(1) =20 Potential physical hazards while performing the tasks discussed = in the=20 previous section include ergonomic issues associated with heavy lifting = and=20 associated body strains; temperature extremes; slips, trips, and falls; = contact=20 with sharps; contact with poisonous plants, animals, and/or insects, = including=20 animal bites; injury from mechanical equipment; electrical noise = hazards;=20 explosions; and compressed gases.

(2) = The=20 potential consequences of unmitigated physical hazards include strains, = sprains,=20 fractures, loss of limbs, death, lacerations, contusions, electrocution, = burns,=20 hearing loss, blindness, hypothermia, heat stress, and skin=20 irritation.

&nbs= p; =20 g. =20 Chemical hazards of biohazardous waste = operations

(1) =20 Potential chemical hazards during biohazardous waste operations = could=20 arise from chemicals used during sample preparation and analysis,=20 decontamination, spill clean-up, equipment operation, and waste = treatment.

(2) =20 Chemical exposures can occur by dermal contact, absorption = through mucous=20 membranes, injection, inhalation, or ingestion.

(3) = The=20 consequences of such exposures vary depending on chemical type and=20 concentration, how it was used, and environmental conditions during its=20 use. Possible effects of = chemical=20 exposure include burns, poisoning, acute symptoms, cancer, reproductive = effects,=20 mutations, birth defects, death, environmental contamination, fire and=20 explosion.

(4) =20 Chemical suppliers are required to provide Material Safety Data = Sheets=20 (MSDS) for the materials they sell, which contain information about how = to=20 prevent and treat specific chemical exposures; these should be reviewed = prior to=20 using the chemical. =20

h. =20 Biological hazards of biohazardous waste operations. Biological hazards are likely = to be=20 present during biohazardous waste operations. The severity of the hazard = depends on=20 the specific agent, the concentration of the agent in the exposure = medium, the=20 health of the exposed individual, route of transmission, and many other=20 factors. =

(1) =20 Exposure can occur through dermal contact, mucous membrane = absorption,=20 injection, inhalation, or ingestion, and can result in infection, = intoxication,=20 or transmission of infection to others hosts via fomites or other = routes.=20

(2) = Depending=20 on the agent, an infection with a human or zoonotic pathogen, or = intoxication by=20 a biological toxin, can cause varying levels of morbidity and = mortality.

(3) =20 Released agricultural pathogens which are not transmitted to = humans may=20 cause economic, trade and environmental impacts if transmitted to a = susceptible=20 host.

i. =20 Radiation (ionizing/non-ionizing) hazards of biohazardous waste=20 operations. Ionizing = radiation=20 refers to alpha, beta, gamma, and neutral particles that can cause = tissue damage=20 by the ionization of cellular components. =20 Non-ionizing radiation refers to UV, visible light, infrared, and = microwaves that cause injury to tissue by thermal or photochemical = means. Radiation hazards may be = encountered=20 during any phase of biohazardous waste operations if radiation sources = are=20 present in the work area, the waste or as part of the decontamination = operation.=20

(1) =20 Exposure to radiation can occur through dermal exposure, = inhalation, or=20 ingestion, depending on the type of radiation, the proximity to the = source, and=20 the duration of exposure. =20

(2) =20 Radiation exposure in humans can result in cancer, reproductive = effects,=20 burns, and death.

j. =20 Hazard controls for biohazardous waste. Hazard controls can be grouped = into=20 three categories: 1) = engineering=20 controls; 2) administrative controls; and 3) personal protective = equipment=20 (PPE). In general, = engineering=20 controls are preferred to administrative controls or PPE because = engineering=20 controls are typically mechanized or structural, and therefore less = subject to=20 failure due to human error. =20

A=20 detailed Job Hazard Analysis must be performed by a person experienced = in hazard=20 analysis for each biohazardous waste disposal operation task prior to = initiating=20 the task in order to select the appropriate hazard controls for each=20 situation.

(1) =20 Engineering Controls include:

(a) =20 designing the facility, equipment, or process to remove the=20 hazard

(b) =20 substituting a hazard with a non or lesser = hazard

(d) =20 isolating the hazard with interlocks, machine guards, or other=20 means

(e) =20 removing or redirecting the hazard with local or exhaust = ventilation.=20

(2) =20 Engineering controls that can be used to control the hazards = associated=20 with biohazardous waste disposal operations=20 include:

(a) =20 biological safety cabinets;

(b) = air=20 locks and directional airflow;

(d) =20 process containment (glove boxes);

(e) =20 ergonomic equipment;

(f) =20 assistive devices (remote operations); and

(g) =20 protective barriers (enclosed containers, safety centrifuge=20 cup).

A=20 summary of practices, engineering controls and facilities (secondary = barriers)=20 may be found in the HHS (CDC/NIH) publication, Biosafety in Microbiology = and=20 Biomedical Laboratories (BMBL), 5^th edition located at http://www.= cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm=20 Recommended sections are Section IV, Table 1 =93Summary of recommended = biosafety=20 levels for infectious agents=94 and Section V, Table 1 =93Summary of = recommended=20 biosafety levels for activities in which experimentally or naturally = infected=20 vertebrate animals are used.

Additional guidance on engineering controls and = facilities may=20 be found in Chapters 7, 9, and 10 of The ARS Facilities Design Standard, = Manual=20 242.1 -ARS.

(3) =20 Administrative controls include:

(a) = safe=20 work practices

(b) =20 written standard operating procedures (SOPs), =

(d) =20 exposure time limitations

(e) =20 environmental monitoring

(f) =20 alarms, signs, and warnings

(g) = the=20 buddy system

(h) =20 training. =20

(4) = Some=20 specific administrative controls applicable to the hazards identified = for=20 biohazardous waste disposal operations include:

(a) =20 Restricted access areas

(b) =20 Security features (door locks, electronic entry=20 devices)

(d) =20 SOPs

(e) =20 Training

(f) =20 Signage

(3) =20 Personal Protective Equipment

=20 Personal Protective Equipment (PPE) is a type of primary barrier = worn by=20 the employee, and should only be used if engineering and administrative = controls=20 do not provide sufficient protection. =20 PPE includes gloves, lab coats, coveralls, gowns, shoe = covers,=20 boots, respirators, face shields, safety glasses, goggles, and hearing=20 protection. The sections = referenced=20 within the BMBL 5^th edition provided in section 13, j(2)g of = this=20 manual provide guidance on PPE appropriate to the various biosafety = levels (BSL)=20 and animal biosafety levels (ABSL).

PPE=20 must be carefully selected based on the specific hazards and conditions=20 identified in the Job Hazard Analysis. =20 Comfort should also be considered to ensure maximum compliance = with PPE=20 requirements. Below is a = list of=20 PPE categories with associated selection considerations which may be = applicable=20 to biohazardous waste disposal operations.

(a) =20 Head protection =96 hard hats should be used in the = presence of=20 operational heavy equipment, or if the possibility exists that falling = objects=20 could strike and injure employees or visitors at the worksite. Chemical-resistant head = coverings are=20 recommended if the potential exists for dermal contact with skin = irritants; if=20 so, PPE providing head protection must prevent dermal contact with the = hazardous=20 substance.

(b) =20 Eye protection =96 Appropriate eye protection (safety = goggles,=20 glasses, and face shield) must be worn if chemicals, pathogens, dust, = particles,=20 or flying objects may be present. =20 The material and type of the eye protection must be carefully = selected to=20 ensure resistance to the specific hazards at the worksite.

(c) =20 Hand protection =96 gloves must be selected based on the = expected=20 hazard. Many safety = equipment=20 suppliers have charts showing recommended hand protection for various = hazards;=20 material should be selected to ensure the gloves will not be compromised = by=20 tears or otherwise damaged upon contact with the hazardous = substance.

(d) =20 Respiratory protection =96 the respirator must be selected = based on=20 the type and concentration of the breathing hazard, the fit-test results = for the=20 wearer, and suitability for the task. =20 Employees wearing respirators must be enrolled in a Respiratory=20 Protection Program in accordance with OSHA requirements.

(e) =20 Foot protection =96 foot protection must be selected based = on the=20 type of hazard. = Steel-toed or=20 similar shoes are required where heavy items may fall, and additional = protection=20 is required when metal drums are handled. =20 Boot or shoe covers may be required to prevent tracking of = contaminants=20 from one area to another, and must be slip resistant and impervious to = damage=20 from chemical hazards. In = laboratory environments, open toed-shoes (sandals, etc.) shall not be = worn by=20 employees or visitors. =

(f) =20 Hearing protection =96 hearing protection must be selected = based on=20 the noise level at the worksite and in accordance with OSHA standards. =

(g) =20 Skin/clothing protection =96 protective clothing must be = selected=20 based on a risk assessment which considers the type of work to be = performed, the=20 nature of the hazards to be encountered, and resistance to break=20 through/penetration of biological hazards or chemical hazards in the=20 worksite. All protective = clothing=20 is either disposed of in the work area or decontaminated and laundered = by the=20 institution or decontaminated at the facility and laundered by a=20 vendor/contractor who has been made aware of any potential risks. Home laundering of protective = clothing=20 is prohibited.

(4) =20 Medical monitoring and other medical issues

Section=20 VII of BMBL, =93Occupational Health and Immunoprophylaxis,=94 discusses = occupational=20 health/medical monitoring in detail. =20 This section provides a summary of the BMBL information as it = pertains to=20 biohazardous waste issues. = The BMBL=20 should be consulted for complete guidance on these issues.=20

As discussed earlier in this section, each job = task should=20 undergo a Job Hazard Analysis. = The=20 analysis will identify specific risks, some of which may require the = services of=20 a occupational health provider. =20 These medical services must comply with OSHA regulations, = patient=20 confidentiality laws (i.e. HIPPA), and the Americans with Disabilities = Act of=20 1990. Occupational medical services may be provided through in-house, = contracted=20 or community based professionals, as long as the service is readily = available=20 and allows timely and appropriate medical evaluation and treatment. The = medical=20 provider must be knowledgeable about the nature of potential health = risks in the=20 biohazardous waste work environment and have access to expert = consultation.

Medical=20 support services for USDA facilities should be evaluated annually. Joint = annual=20 reviews of occupational injury and illness reports by healthcare = providers and=20 environmental health and safety representatives can facilitate the = revision of=20 exposure prevention strategies to minimize the occupational health = hazards that=20 cannot be eliminated.

(a) =20 Preplacement Medical Evaluations should be considered for = workers=20 who may be exposed to human pathogens, zoonotic pathogens, toxins, = hazardous=20 chemicals, physical hazards and ionizing radiation during the course of = their=20 work.

(b) =20 Healthcare providers should be cognizant of potential hazards = associated=20 with biohazardous waste handling or decontamination operations.

(c) =20 Information from the job hazard analysis and individual history = that=20 should be obtained by the occupational health providers should include: =

=B7 = ; =20 a description of the requirements for the = position;

=B7 = ; =20 potential health hazards present in the = work=20 environment;

=B7 = ; =20 worker=92s previous and ongoing medical=20 problems;

=B7 = ; =20 current medications;

=B7 = ; =20 allergies to medicines, animals, and = other=20 environmental proteins;

=B7 = ; =20 prior immunizations; and

=B7 = ; =20 pre-existing medical records, if needed. =

(d) =20 Healthcare provider responsibilities include the following:

=B7 = ; =20 identify needed medical services based on = job=20 requirements.

=B7 = ; =20 Provide fitness for duty=20 examinations/consultation

=B7 = ; =20 evaluate individual=92s vulnerability to = exposure=20 to potential job-related hazards (e.g.,, immunodeficient workers, = workers of=20 reproductive age)

=B7 = ; =20 establish optional serologic = documentation that=20 individual workers have pre-existing immunity to specific = infections

=B7 = ; =20 evaluate clearance for respirator use, if = applicable.

(e) =20 Periodic medical evaluations or medical clearances = targeted to job=20 requirements may be warranted for respirator use or for workers with = substantial=20 risk of exposure to infectious agents to detect pre-clinical or = sub-clinical=20 evidence for an occupationally acquired infection. Refer to previous section for=20 information related to healthcare provider capabilities, information for = healthcare provider, and healthcare provider responsibilities.

(f) =20 Medical support for occupational illnesses and injuries should be = provided in the following circumstances:

=B7 = ; =20 to any worker experiencing symptoms they = suspect=20 may be related to infectious agents, toxins or other biohazards in their = work=20 area.

=B7 = ; =20 to workers or visitors to worksites = containing=20 biohazards who experience =20 unexplained illness

(g) =20 Healthcare providers must possess the following attributes:

=B7 = ; =20 a working understanding of the biohazards = present=20 in the workplace

=B7 = ; =20 an ability to identify subtle evidence of = infection and atypical presentations

=B7 = ; =20 an ability to maintain close working = relationship=20 with employee=92s research or clinical program

=B7 = ; =20 a willingness to interact closely with = employee=20 and the employee=92s supervisor to facilitate adequate medical = management and=20 recordkeeping.

(h) =20 Employees are responsible for reporting all occupational = injuries,=20 including exposures to biological hazards, to the appropriate = supervisor/line=20 management and medical support services providers

(i) =20 Employers are responsible for the following:

=B7 = ; =20 Preparing emergency response plan in = advance (see=20 Section 13 (j)(6) =93Emergency Response=94 for additional = information)

=B7 = ; =20 Training employees on biohazard response=20 plans

=B7 = ; =20 Providing all necessary tools and = equipment to=20 execute biohazard response plans

=B7 = ; =20 Providing wound-cleansing facilities and = first=20 aid supplies near work area

=B7 = ; =20 Eliminating barriers to medical = evaluation and=20 treatment

=B7 = ; =20 Maintaining SOPs near work areas that = include=20 printed summaries of recommended medical responses to specific exposures = that=20 can be used to guide immediate responses in the work place and for the = reference=20 of the facility treating the injured worker

=B7 = ; =20 Consider collecting and storing a serum = specimen=20 prior to the initiation of work when occupational exposure to human or = zoonotic=20 pathogens is a risk. The sample can be used to establish baseline=20 sero-reactivity, should additional blood samples be collected for = serological=20 testing subsequent to a recognized or suspected exposure.

=B7 = ; =20 Providing applicable workers=92 = compensation claim=20 form(s) with instructions for completion

=B7 = ; =20 Obtaining a description of accidents or=20 incidents,

=B7 = ; =20 Confirming the circumstances of injuries = or=20 exposures

=B7 = ; =20 Distributing report to all other relevant = parties, such as the safety professional.

=B7 = ; =20 Evaluating initial job hazard = analysis/risk=20 assessments and modify procedures if necessary to prevent recurrence of = the=20 incident.

(j) =20 Healthcare provider(s) are responsible for:

1 =20 providing descriptions of the injury, including:

=B7 = ; =20 identification of potential infectious = agent or=20 biohazard.

=B7 = ; =20 mechanism and route of exposure = (percutaneous,=20 splash to mucous membranes or skin, aerosol, etc.)

=B7 = ; =20 the time and place of the incident

=B7 = ; =20 personal protective equipment used at the = time of=20 the injury

=B7 = ; =20 prior first aid provided (e.g.,, nature = and=20 duration of cleaning and other aid, time that lapsed from exposure to=20 treatment)

=B7 = ; =20 aspects of the worker=92s personal = medical history=20 relevant to risk of infection or complications from treatment

2 =20 Repeating first aid if the initial adequacy is in question

3 =20 Using appropriate barrier precautions to avoid exposure to = infectious=20 agents and toxins

4 =20 Administering post-exposure prophylaxis, if applicable

5 =20 Consulting with subject matter experts if needed

6 =20 carefully explaining the clinical risk assessment and treatment = decision=20 process

7 =20 Addressing the worker=92s questions

8 =20 Providing relevant, preprinted educational materials if = available

9 =20 Providing prompt treatment

10 =20 Providing treatment plan for employee to follow

11 =20 Performing post-exposure serologic testing if appropriate, and = ensuring=20 tests are administered at appropriate time intervals after exposure

12 =20 Compare post-exposure serologic testing with baseline and over = time, as=20 appropriate.

(5) =20 Vaccines

Section=20 VII of BMBL, =93Occupational Health and Immunoprophylaxis,=94 discusses immunoprophylaxis = (vaccines)=20 in detail. This section = summarizes=20 information from the BMBL as it applies to biohazardous waste=20 issues.

(a) = This=20 section applies to employees who are occupationally exposed to = infectious=20 agents

(b) =20 Employers have the following responsibilities for ensuring their=20 employees are properly vaccinated:

1 =20 In accordance with the Advisory Committee on Immunization = Practices,=20 provide commercial vaccines on a voluntary basis to workers = occupationally=20 exposed to infectious agents (recommendations found at http://www.cdc.gov/).

2 =20 Provide current, applicable vaccine information statements = whenever a=20 vaccine is administered.

3 =20 Evaluate each worker=92s immunization history for completeness = and currency=20 at the time of employment and re-evaluate when the individual is = assigned job=20 responsibilities with a new biohazard.

4 =20 Consider using vaccines or immune serum preparations that are=20 investigational or as an off-label use only when occupational exposure = to highly=20 pathogenic agents is possible and no commercial vaccine is available; = this must=20 be accompanied by adequate informed consent and in accordance with=20 Investigational New Drug protocols.

(6) =20 Emergency Response

In=20 order to ensure adequate post-exposure emergency response, an emergency = response=20 plan must be developed in advance of an emergency. The emergency response plan = should=20 include the following exposure-specific information:

=B7 = ; =20 Appropriate first aid

=B7 = ; =20 Potential post-exposure prophylaxis = options,=20 applicability, and limitations

=B7 = ; =20 Recommended diagnostic tests

=B7 = ; =20 Sources of expert medical evaluation

=B7 = ; =20 Procedures for exposures that occur = outside of=20 regular work hours

These=20 protocols should be distributed to potential healthcare providers (e.g., = local=20 hospital emergency departments). In some cases, the protocols should be = reviewed=20 with state and community public health departments.

(7) = Training

(a) =20 Training may take the form of individual instruction, group = seminars,=20 audiovisual presentations, handout material, or any other format that=20 communicates safe handling and hazard awareness to the employee.

(b) =20 Prospective workers should be educated about the = biohazards to=20 which they may be occupationally exposed, the types of exposures that = place=20 their health at risk, the nature and significance of such risks, the = appropriate=20 first aid and follow up for potential exposures, and how to report = exposures or=20 suspected exposures.

(c) = This=20 information should be reinforced annually, as well as at the time of any = significant change in job responsibility and following recognized and = suspected=20 exposures.

(d) =20 Emergency incident training and drills should be provided on a = regular=20 basis for all affected employees. =20 The training should include the contents and use of the Emergency = Response Plan.

(e) =20 Training must be provided at the time of an employee's initial = assignment=20 to a work area where known biohazards are present, and prior to an = assignment=20 involving new exposure situations. =20 Employees must receive periodic refresher information and = training as new=20 information becomes available. =20

(f) =20 All training must be documented.

14. =20 ENVIRONMENTAL DISPOSAL CONSIDERATIONS FOR BIOHAZARDOUS=20 WASTE

The=20 purpose of this section is to provide information on environmental = regulatory=20 issues as they relate to the disposal of biohazardous waste. Many different activities = within USDA=20 generate biohazardous waste. = Some=20 of the components in these wastes can be detrimental to human health, = livestock=20 (animals), plants and/or the environment if not properly managed.

It is=20 USDA policy to follow all Federal, State, or local laws and regulations=20 regarding biohazardous waste. = If=20 standards vary, the more stringent requirement should apply.

a. =20 Responsibilities

(1) =20 Laboratory managers and supervisors are responsible for = proper=20 biohazardous waste disposal procedures and for training employees in = these=20 procedures.

(2) = All=20 laboratory employees are responsible for following proper = biohazardous=20 waste disposal procedures.

(3) = The=20 EPA does not generally regulate biohazardous waste. Exceptions include Clean Air = Act=20 regulations for medical waste incinerators and chemical treatment = systems,=20 biotechnology products such as bioremediation microorganisms regulated = under the=20 Toxic Substance Control Act, and biopesticides regulated under = FIFRA.

(4) =20 Although there are no Federal EPA requirements for the = management=20 and disposal of biohazardous waste, most States do regulate biohazardous = waste=20 streams. Additionally, States with EPA approved programs have authority = over=20 medical waste incinerators, chemical treatment systems, etc. There are a number of waste = categories=20 (i.e., sharps, cultures and stocks, animal wastes, etc.) and treatment,=20 destruction, and disposal methods vary for each.

(a) = The=20 State=92s Department of Natural Resources Office should be contacted to = obtain=20 current requirements prior to making any decision on the manner in which = biohazardous waste will be disposed. =20

(b) = Prior=20 to generating waste, the waste generator must determine if a feasible = disposal=20 path exists for the proposed waste stream. No wastes should be generated = until a=20 disposal path has been identified and developed.

(c) =20 Biohazardous waste streams containing a chemical and/or = radiological=20 component are considered multiple-hazard wastes. Such wastes=20 must be treated to eliminate the biohazard prior to disposal. After treatment, the waste = must be=20 managed pursuant to the regulations that apply to its = non-biological=20 component. For example, a = waste=20 containing a biohazardous component and a Resource Conservation and = Recovery Act=20 (RCRA) regulated constituent must be managed as a RCRA hazardous = waste.

(5) = Local=20 Authorities: = Biohazardous=20 waste that has been rendered noninfectious may qualify for disposal at = the local=20 landfill or Publicly Owned Treatment Works. Waste generators should = contact local=20 authorities to discuss and seek approval for this action. All verbal approvals obtained = from local=20 authorities should be documented in a follow up letter that details the = types of=20 wastes to be disposed, processes that will be utilized to render the = material=20 noninfectious, quality control practices, etc.

=20 b. =20 Waste Minimization

(1) =20 Pollution prevention and waste minimization procedures = should be=20 incorporated wherever feasible. An effective biohazardous waste program = protects=20 workers and the environment and can result in cost savings from waste = reduction=20 or prevention. Personnel = should=20 diligently investigate and pursue opportunities to use materials with a = lower=20 biohazard level or alternative procedures to reduce the material = handling and=20 disposal requirements. = These=20 practices will reduce biohazardous waste steams and ensure that = biohazardous=20 wastes are handled and treated appropriately.

(2) = A=20 primary means of reducing biohazardous waste is to ensure that it = is=20 separated from general waste, which should occur at the point of=20 generation.

(a) =20 Biohazardous waste should be placed directly into =93biological = hazard=94=20 labeled or color coded containers or plastic bags clearly identifiable = and=20 distinguishable from the general solid waste stream.

(b) =20 Temporary markings or a second container or bag should be used if = the=20 waste is to be decontaminated prior to disposal.

=20 c. =20 Additional Information

There are many sources = of=20 information available regarding biohazardous waste disposal, including = Federal=20 and State guidelines regarding the disposal of biohazardous waste, which = can be=20 found at www.epa.gov/epaos= wer/other/medical/#two

15. = SECURITY=20 PARAMETERS FOR BIOHAZARDOUS WASTE

This=20 section sets policy and procedure to ensure appropriate levels of = protection for=20 securing and safeguarding biohazardous waste during its generation and=20 packaging, transport (either on or off-site), storage (either on or = off-site)=20 and scheduled destruction. = This=20 section also details protection levels required in accordance with = potential=20 consequences, and ensures effective security planning and coordination = between=20 the government and local authorities in the proper disposal of = biohazardous=20 waste. This section does = not cover=20 incidents resulting from declared agricultural emergencies.

a. =20 Disposal sites

The=20 design of disposal sites varies, depending on the type of biohazardous = waste, so=20 it is necessary to refer to all relevant Federal, State, local, and = facility=20 regulations to ensure regulatory compliance when selecting a site for=20 biohazardous waste disposal.

(1) =20 On-site disposal area, or location: A designated area within the = property=20 of a given USDA facility properly designed to store, handle and dispose = of=20 biohazardous waste.

(2) =20 Off-site disposal area, or location: A commercial facility that = is=20 properly permitted to receive, store, handle, and dispose of = biohazardous=20 waste.

b. =20 Common Carrier and Transportation Vehicles

Biohazardous waste = should be=20 transported in closed leak-proof trucks or dumpsters. Secondary containment may be = needed as=20 well, depending on the type of biohazardous waste being transported.

(1) =20 Vehicles used for transporting Category A and Category B = biohazardous=20 waste (see Definitions) should be in good mechanical condition and = strong enough=20 to carry the load without difficulty. =20 If vehicles do not have a closed body, the body should be covered = with a=20 tarpaulin. Vehicle selection should include, but not be limited to:

=B7 = ; =20 Transporting infected carcasses.

=B7 = ; =20 Transporting infected live animals.

=B7 =20 =20 Transporting clinical and diagnostic cultures.

(2) =20 Vehicles should be properly marked with the appropriate UN = identifier.=20 Additional labeling and placards as noted below should be in accordance = with 49=20 CFR 172.323 and 49 CFR 172.432, if the vehicle will travel on public = access=20 roads or otherwise enter commerce.

=B7 = ; =20 Biohazard- See Figure 1

=B7 = ; =20 Infectious Substance- See Figure 2

(3) =20 Unless provided by the common carrier, the shipper should provide = all=20 required shipping labels and placards in accordance with 49 CFR 172.505- = Providing and affixing placards: Highway.

(4) =20 Common carrier drivers should have a valid state driver=92s = license=20 appropriate for the type of vehicle commissioned to transport = biohazardous=20 waste, and/or a Commercial Driver License (CDL) for operating vehicles = that=20 require a CDL.

(5) =20 Common carrier should be licensed or certified/permitted to = transport=20 biohazardous waste.

c. =20 Additional common carrier responsibilities

(1) = The=20 common carrier is responsible and liable for the safe transport and=20 accountability of the biohazardous waste once the carrier has accepted = the=20 biohazardous waste from the shipper of record.

(2) =20 Acceptance includes the signature receipt of the hazardous waste = manifest=20 [49 CFR 172, Subpart C,=20 =A7172.205(c)(2)].

(3) =20 Unless approved by USDA, the common carrier of record should not = transfer=20 the biohazardous waste to another common carrier for transport.

(4) = Upon=20 delivery to the designated receiving facility, the receiving facility = becomes=20 responsible for disposing of the biohazardous waste accepted from the = common=20 carrier of record. Note = that USDA=20 is still liable for the waste from cradle to grave, so it is prudent for = USDA to=20 confirm that the receiving facility is disposing of USDA=92s = biohazardous waste in=20 compliance with relevant laws and regulations.

(5) =20 Acceptance includes the signature receipt of the hazardous waste = manifest=20 [49 CFR 172, Subpart C,=20 =A7172.205(d)(2)].

(6) =20 Unless approved by USDA, the receiving facility of record should = not=20 transfer the biohazardous waste to another facility for disposal.

d. =20 Additional security precautions during transport

&nbs= p; =20

(1) = In=20 compliance with Department of Transportation (DOT) regulations, the USDA = location and the transporter of the biohazardous waste (if different = entity than=20 USDA location) must develop and implement a security plan if the = following types=20 or quantities of hazardous materials will be transported [49 CFR 172, Subpart I, = =A7172.800]:

(a) =20 hazardous material in an amount that must be placarded in = accordance with=20 the Hazardous Materials Regulations;

(b) =20 hazardous material in a bulk packaging having a capacity equal to = or=20 greater than 13,248 L (3,500 gallons) for liquids or gases or more than = 13.24=20 cubic meters (468 cubic feet) for solids; or

(c) =20 select agents or toxins regulated by the CDC under 42 CFR Part = 73, or=20 USDA under 9 CFR Part 121 [49 = CFR Part=20 172, Subpart I, =A7172.800(6)]. =20 USDA facilities generating biohazardous or medical waste = containing=20 select agents and toxins shall need to develop a transportation security = facility plan.

(2) = At a=20 minimum, a security plan must include provisions for the following = elements [49 CFR Part 172, Subpart I,=20 =A7172.802]:

(a) =20 Personnel security;

(b) =20 Preventing unauthorized access; and

DOT=92s=20 pamphlet, =93Hazardous Materials Transportation Enhanced Security = Requirements,=20 DHM50-0030-0903,=94 has additional information on this topic.

The=20 security plan must be in writing and must be retained for as long as it = remains=20 in effect. The security plan must be revised as necessary to reflect = changing=20 circumstances. When applicable, transportation security plans developed = under=20 Sections 15(d)(1)(c) and 15(g) must be submitted to the USDA Animal and = Plant=20 Health Inspection Service or CDC Select Agent Program(s) for = approval.

(3) = A=20 means of communication should be established between the transport = driver, and=20 the originating and receiving stations, including radios, cell phones, = or=20 similar devices. The = transport=20 driver and the originating and receiving stations will be provided with = all=20 relevant contact numbers. If transportation of the biohazardous waste to = the=20 receiving station exceeds one (1) day, or in the event of an unplanned = layover=20 exceeding one (1) day, the transport driver should make contact with the = originating station and receiving station at least every eight (8) = hours.

(4) =20 Unless pre-arranged, stops and overnight layovers should not be=20 permitted. In the event of an unanticipated layover (i.e., vehicle = breakdown,=20 weather, traffic incident, etc.), the transporting vehicle should be = secured to=20 prevent unwanted intrusions. = The=20 driver should report any delay to the point of contact at the = originating=20 station and receiving station, and should remain with the vehicle until = the=20 vehicle is transported to a safe location and properly secured. Local law enforcement should = be advised=20 of the nature of the cargo that is being temporarily secured.

e. =20 USDA On-site Storage and Disposal Security Requirements

All=20 transportation of biohazardous waste generated at USDA facilities must = be=20 conducted in compliance with all Federal, State, local, and facility=20 regulations, including all applicable DOT regulations. Each laboratory must obtain = and comply=20 with the regulations for its location. The=20 importation or interstate movement of infested or potentially infested = plant=20 material requires an APHIS PPQ 526 Plant Pest Permit. The permit conditions will = include=20 information about proper packaging, transport, and sterilization=20 procedures.=20

(1) =20 Movement and handling of biohazardous waste should be kept to a = minimum,=20 and disposal preparation should be done as outlined in Sections 10, 11 = and=20 12. =20 The use of mechanical loading devices which may rupture = packaged=20 wastes should be avoided.

(2) = All=20 bags containing biohazardous waste should be properly labeled in = accordance with=20 Section 15(b)(2).

(3) =20 Animal bedding, manure and/or mixture should be bagged in=20 bio-degradable material in order to establish a numerical account for=20 manifesting.

(4) = A=20 transfer/chain-of-custody form (see Figure 3 for sample document) should = be=20 prepared to document the biohazardous waste product that is being = disposed.=20 Laboratory should maintain a logbook to record chain-of-custody = events.

(5) = An=20 accurate, current inventory for each biohazardous product must be = maintained if=20 held in short-term or long-term storage.

(6) = USDA=20 worksites and locations must establish a designated storage area for=20 biohazardous waste that is not disposed of immediately. Such storage areas must be = adequately=20 secured to prevent theft or release of biohazardous waste material. Packaging integrity, storage=20 temperature, storage duration, and storage location should be evaluated = to=20 ensure that the delay in treatment will not create potentially hazardous = conditions.

(a) =20 Temporary storage shelters should have secondary containment = provisions=20 for liquid waste or waste susceptible to leakage, such as concrete = curbing or=20 similar impervious barriers to prevent release to the environment.

(b) = The=20 packaging should deter rodents and vermin, and should be strong enough = to block=20 or mitigate the emission of any unpleasant odors that might = develop.

(c) =20 Storage site location and security should also be assessed to = ensure they=20 meet established requirements for biohazardous waste.

(d) =20 Biohazardous waste held in storage for more that one (1) day = should be=20 physically checked daily, and verified against the inventory log, for = each day=20 in storage.

(e) = The=20 locking devices will also be checked daily.

(f) =20 Long-term and short-term storage areas should be properly = identified with=20 applicable labels similar to the requirements of OSHA Subpart Z Section=20 1910.1030(g)-Communication of hazards to employees.

(7) = Prior=20 to destruction, an inventory should be conducted to ensure that all = biohazardous=20 waste has been accounted for.

(8) = USDA=20 facilities that have remote disposal sites (i.e., incinerators) within = the=20 facility property should secure and transport biohazardous waste in = properly=20 maintained vehicles. =

(9) = USDA=20 laboratories utilizing on-site disposal areas should have an emergency = response=20 plan in place to appropriately address incidents involving theft, loss, = or=20 release of biohazardous waste scheduled for destruction.

(10) All = documentation=20 records related to the transportation and disposal of biohazardous waste = at USDA=20 on-site locations Records must be retired = to FRC 5=20 years after completion of shipment to an offsite disposal/treatment=20 facility. = Agencies=20 should consider maintaining infectious medical waste records for = =93longer periods=20 of time, such as 15 years with subsequent = transfer to=20 NARA = for storage=20 as permanent records (e.g. Waste containing environmentally = stable agents=20 or that have a hazardous waste component and could be a continuing concern in the event that the = waste is=20 improperly disposed of by the receiving site). Generators should also review = State and=20 local regulations to ensure they do not have more stringent = requirements.

f. =20 Non-USDA Off-site Storage and Disposal Security Requirements

=20

(1) = Prior=20 to any interstate transport of biohazardous waste to an off-site = disposal=20 location, the facility/Location Environmental or Biosafety = Specialist/Officer=20 should notify and coordinate with state and local transportation = authorities to=20 verify any transport restrictions and obtain any necessary permit=20 requirements. Such = transport should=20 have a pre-established primary route and secondary route in the event of = inclement weather or traffic incidents. =20

(2) =20 Disposal site should be a properly licensed/certified = organization and=20 permitted to handle the type of biohazardous waste being = transported.

(3) =20 Disposal preparation should be done as outlined in Sections 9 = through 11=20 of this document.

(4) =20 All bags containing biohazardous waste should be properly = labeled=20 in accordance with Section = 15(b)(2). = In addition, animal bedding, manure and/or = mixture=20 should be bagged in bio-degradable material in order to establish a = numerical=20 account for manifesting.

(5) = All=20 biohazardous waste should be placed into appropriate USDOT rigid or = semi-rigid=20 containers before transport off-site.

(6) = A=20 transfer/chain-of-custody form (see Figure 3 for sample document) should = be=20 prepared to document the biohazardous waste product that is being = disposed. The=20 laboratory should maintain a logbook to record chain-of-custody = events.

(7) A = shipment=20 manifest should be prepared for animal carcasses and/or live animals = scheduled=20 for disposal. Manifests = should=20 include type of biohazardous waste, quantity (quantity should not be by = volume=20 or weight), method of disposal (see Sections 9, 10, and 11), date of=20 departure/arrival, and signature of authorizing USDA agent. Manifests = should=20 accompany the biohazardous waste. =20 When applicable, shipment manifests should be in accordance with = 49 CFR=20 172.205 =93Hazardous waste manifest=94.

(8) = In the=20 event that the disposal cannot be performed at the scheduled time and = there is a=20 delay of more than one (1) day, the off-site disposal facility must = provide a=20 secured location for transport vehicles, freezers, or other means of = storage=20 until the disposal is complete.

(a) = Such=20 storage areas, whether a truck yard, room, trailer, freezer, or = refrigerator,=20 must have appropriate locking devices to secure the material.

(b) =20 Biohazardous waste held in storage for more than one (1) day = should be=20 physically checked daily, and verified against the inventory log or = shipping=20 manifest for each day in storage. =20 In addition, the locking devices should be checked daily.

(c) =20 Long-term and short-term storage areas should be properly = identified with=20 applicable labels similar to the requirements of OSHA Subpart Z Section=20 1910.1030(g)-Communication of hazards to employees.

(d) = If=20 treatment cannot be accomplished on the day the waste is generated, = packaging=20 integrity, storage temperature, storage duration, and storage location = should be=20 evaluated to ensure that the delay in treatment will not create = potentially=20 hazardous conditions. =

1 =20 Temporary storage shelters should have secondary containment = provisions=20 for liquid waste or waste susceptible to leakage, such as concrete = curbing or=20 similar impervious barriers to prevent release to the environment.

2 =20 The packaging should deter rodents and vermin, and should be = strong=20 enough to block or mitigate the emission of any unpleasant odors that = might=20 develop.

3 =20 Storage site location and security should also be assessed to = ensure they=20 meet established requirements for biohazardous waste.

(9) = Prior=20 to destruction, an inventory should be conducted to ensure that all = biohazardous=20 wastes have been accounted for.

(10) A USDA = agent=20 should witness each disposal event to certify that it was completed in=20 compliance with all relevant agreements, regulations, etc.

(11) All = documentation=20 records related to the transportation and disposal of biohazardous waste = utilizing USDA off-site disposal locations should be prepared and = retained in=20 accordance with DOT 49 CFR 172, Subpart C- Shipping Paper. Records must = be retired to FRC 5 years after completion of = shipment to an=20 offsite disposal/treatment facility. =20 Agencies = should=20 consider maintaining infectious medical waste records for =93longer = periods of=20 time, such as 15 years with subsequent = transfer to=20 NARA = for storage=20 as permanent records (e.g. Waste containing environmentally = stable agents=20 or that have a hazardous waste component and could be a continuing concern in the event that the = waste is=20 improperly disposed of by the receiving site). Generators should also review = State and=20 local regulations to ensure they do not have more stringent = requirements.

g. = ; =20 USDA Facilities that Possess, Use, and Transfer = Select=20 Agents and Toxins

The=20 following security requirements apply to those USDA facilities that = generate=20 biological waste deriving from select agents and toxins whether for = on-site or=20 off-site disposal.

(1) = Security of=20 select agents and toxins shall comply with

= 7 CFR Part=20 331.11, 9 CFR Part 121.11 and 42 CFR Part

=20 73.11.

(2) =20 Storage, transfer, transportation, and disposal = of=20 select agents and toxins shall comply with 7 CFR Part 331.11/16/17;

9=20 CFR Part 121.11/16/17; and 42 CFR Part 73.11/16/17. Storage, transfer, and = transportation of=20 select agents and toxins to an off-site unregistered entity shall = require prior=20 approval of the Agriculture Select Agent Program (telephone number (301) = 734-5960).

(3) =20 Emergency response plans for biohazardous waste=20 involving select agents and toxins shall comply with 7 CFR 331.14, 9 CFR = 121.14=20 or 42 CFR 73.14.

(4) = All=20 documentation related to select agents and toxins shall comply with 7 = CFR=20 331.17(c), 9 CFR 121.17(c), and 42 CFR 73.17(c).

h. = ; =20 Emergency Response Plans

To ensure the safety of the general public and the = environment=20 the shipper should develop emergency response plans.

(1) = USDA=20 utilizing on-site disposal areas should have in-place an emergency = response plan=20 to address incidents involving theft, loss or release of a biohazardous = waste=20 scheduled for destruction.

(2) = USDA=20 laboratories utilizing off-site disposal areas requiring the = transportation of=20 biohazardous waste scheduled for destruction via common carrier should = provide=20 emergency response information in accordance with 49 CFR 172, Subpart G- = Emergency Response Information. The emergency response information = should be=20 coordinated with the transportation security plan as outlined in 49 CFR = 171,=20 Subpart I-Security Plans.

FIGURE=20 1. BIOHAZARD LABEL [49 = CFR=20 172.323]

3D"Image

FIGURE=20 2. INFECTIOUS SUBSTANCE = LABEL [49=20 CFR 172.432]

3D"Image

FIGURE 3. SAMPLE TRANSFER AND CHAIN OF = CUSTODY=20 FORM

Section 1=20