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1.0 Introduction

Laboratories handling biohazardous agents are special, often unique, environments that may pose an infectious disease risk to persons in or near them.  Fewer than 20 percent of all cases of laboratory-acquired infections are associated with a known incident.  Exposure to infectious aerosols is a plausible, but usually unconfirmed, source of infection.  The knowledge, techniques and equipment needed to prevent most laboratory-acquired infections are readily available.  This publication was prepared as an aid to researchers to prevent the infection of laboratory workers and ancillary personnel.  It serves as the written Biological Safety Program for facilities at The University of Iowa.  All personnel engaged in the use of infectious or hazardous biological (biohazardous) agents must participate in this program. 

The goal of the University's Biological Safety Program is to protect staff, students and the environment from exposure to biohazardous agents, as well as the protection of experimental materials.  Prior to removal from the clinical or research laboratory area, biohazardous/infectious wastes must be properly packaged and labeled for subsequent decontamination and disposal.  The responsibility for identifying and disposing of biohazardous materials rests with the PI’s (principal investigators) or laboratory supervisors.  This responsibility cannot be shifted to inexperienced or untrained personnel. 

Principal investigators or laboratory supervisors should call the Biological Safety Section of EHS (Environmental Health & Safety Office) at 335-8501, if there is uncertainty about categorizing, handling, storing, treating, or discarding biologically derived material. 

 

10.0 Select Agents and Toxins

As required by the Public Health Security and Bioterrorism Act of 2002, the DHHS (Department of Health and Human Services) and USDA (United States Department of Agriculture) have set forth rules regarding the possession, use and transfer of select agents and toxins.  The biological agents and toxins subject to these rules have the potential to pose a severe threat to public health and safety, to animal health or to animal products.  These rules, defined as the Select Agent Program, are outlined in the CFR (Code of Federal Regulations), Title 42, part 73, Possession, Use and Transfer of Select Agents and Toxins.  The initial program took effect in 2002; the interim Final Rule has since been replaced with the Final Rule on March 18, 2005.  

In this section an overview of the Select Agent Program will be presented.  The Select Agent Program requires that any facilities, including government agencies, universities, research institutions and commercial entities, that possess, use or transfer select agents or toxins register with the CDC (Center for Disease Control and Prevention) or USDA (United States Department of Agriculture), depending on the agents involved.  For a more detailed description, please visit the CDC’s or USDA’s Select Agent Homepage where a full account of the Final Rule is published.

10.1 All Chemicals: General

General Handling Procedures

  1. Obtain and review Safety Data Sheets (SDS) before ordering and using chemicals. Ensure that the material can be safely procured, stored, used, and disposed of.
  2. Know the hazards associated with materials you are using.
  3. Be prepared for emergencies and know what action to take. Assure that necessary supplies and equipment are available for handling small spills.
  4. Know the location of safety equipment such as emergency shower, eyewash, fire extinguisher, fire alarm, and emergency telephone numbers.
  5. Do not work alone in the laboratory if you are working with chemicals.
  6. Purchase minimum amounts of hazardous materials necessary to accomplish work and dispense only amounts necessary for immediate use.
  7. Use hazardous materials only as directed and for their intended purpose.
  8. Never smell or taste a hazardous chemical.
  9. Avoid direct contact with any chemical, use protective equipment to avoid exposure, and review SDS for specific recommendations for each chemical used.
  10. Smoking, drinking, eating and the application of cosmetics is forbidden in areas where hazardous chemicals are in use.
  11. Ensure emergency contact information is posted at the lab entrance.
  12. Ensure all containers are labeled.
  13. Label all secondary containers with chemical name and hazard information.
  14. Assure ventilation is adequate for the materials you are using. Where possible, handle all materials in a chemical fume hood.
  15. Electrically ground and bond conductive containers using approved methods before transferring or dispensing a flammable liquid from a large container.
  16. Store chemicals in compatible categories.
  17. Only permit reactions to run unattended when the reaction is well understood, provisions are in place to contain toxic substances in the event of a utility failure, and emergency contact information is posted on the door.
  18. Dispose of waste properly according to EHS’s “Waste Management Guidelines and Procedures Manual.” See Resource in section 12.0.
  19. When transporting chemicals outside the lab, use precautions to avoid dropping or spilling chemicals. Use bottle carriers for glass containers and use carts with edges to prevent containers from falling off the cart and breaking.

10.2 Toxins

Hazards

The effects of exposures to toxic chemicals are either acute or chronic. Acute effects are characterized by prompt or slightly delayed health effects, such as burns, allergic reactions, and immediate damage to organs such as eyes. Chronic effects occur over a long periods of time and are characterized by cumulative damage to organs including carcinogenic effects.

Minimizing or eliminating exposure provides protection from toxic hazards. To minimize exposure, it is necessary to determine the route by which exposure may occur, i.e., inhalation, skin contact, ingestion, and injection or puncture.

Precautions

  1. Know the hazards of the material you are using. Review SDS and do additional research if necessary. Use less toxic materials if possible.
  2. Use and store toxic chemicals in established areas and in the smallest possible amounts.
  3. Store and transport toxic chemicals in secondary containment trays.
  4. Use these materials in containment devices such as fume hoods and glove boxes.
  5. Use appropriate protective equipment.
  6. Be prepared for spills and know when to take emergency action.
  7. Wash hands and arms immediately after working with toxic materials.
  8. Never eat, drink, smoke, apply cosmetics, or store food in areas where toxic substances are being used. Never smell or taste a hazardous chemical.
  9. Dispose of wastes in accordance with procedures in the EHS Manual Guidelines and Management of Hazardous Waste. As appropriate, perform chemical decontamination of washes and materials from experiments.
  10. Consider whether additional precautions are needed for substances with high toxicity. See also “Carcinogens, Reproductive Toxins and Highly Toxic Chemicals: Chemical Handling Procedures.”

10.3 Carcinogenic, Reproductive and Highly Toxic Chemicals

REPRODUCTIVE TOXINS and HIGHLY TOXIC CHEMICALS

OSHA defines certain carcinogens, reproductive toxins, and substances with high acute toxicity as Particularly Hazardous Substances (PHS) and requires that employers consider the need for precautions in addition to those for handling toxic substances.

Check the SDS to see if materials meet definitions below. The Hazardous Chemical PHS List available at the EHS website,   lists some common lab substances that meet these definitions.  Many chemicals will have the signal word “Danger” listed on the SDS and the “Health Hazard” pictogram as well as the “Danger” signal word on the container label.  More information about chemical hazard categories is presented in Appendix B.

Definitions

Select Carcinogen – Any substance that meets one of the following criteria:

  1. It is regulated by OSHA as a carcinogen, or
  2. It is listed under the category “Known To Be Human Carcinogens” in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest editions), or
  3. It is listed under Group 1 (Carcinogenic To Humans) by the International Agency for Research on Cancer Monographs (IARC) (latest editions), or
  4. It is listed in either Group 2A (Probably Carcinogenic To Humans) or 2B (Possibly Carcinogenic To Humans) by IARC or under the category, “Reasonably Anticipated To Be Human Carcinogens” by NTP, and causes statistically significant tumor incidence in experimental animals in accordance with any of the following criteria:
  • After inhalation exposure of 6-7 hours per day, 5 days per week, for a significant portion of a lifetime, to dosages of less than 10 mg/m3.
  • After repeated skin application of less than 300 (mg/kg of body weight) per week.
  • After oral dosages of less than 50 mg/kg of body weight per day.

Reproductive Toxins - include substances that can affect reproductive capabilities such as mutagens, which cause chromosome damage, and teratogens, which cause harm to the fetus, and reproductive hazards, which may affect female or male reproductive health.

Highly Toxic Chemicals - a substance (poison) that falls within any of the following categories:

  1. Median lethal dose (LD50) administered orally is <50 mg.
  2. LD50 administered by continuous contact is <200 mg.
  3. Median lethal concentration administered by inhalation is <200 ppm
  4. Any chemical whose properties are unknown.

Precautions

  1. As a minimum, follow precautions section 10.2 of this guide.
  2. Determine whether additional precautions are needed for PHS materials.
  3. Amend or add procedures as needed.
  4. Post the area for use. Inform lab occupants of designated area with Lab Posting Signs. Consider factors such as potency, concentration, quantity, physical properties and conditions surrounding the use of the substances. Specifically consider if additional precautions are needed for: Areas to be designated for use and posted, e.g., fume hood, glove box, or entire room. Containment devices (e.g., fume hood or glove box). Procedures for decontamination and waste disposal. Additional training or personal protective equipment for material users.
  5. List designated areas where additional precautions are needed.
  • Chemical or Substance
  • Building/Room
  • Area Designated for Use

Resource

Antineoplastic Agents Lab Safety

10.4 Flammables and Combustibles

Flammable/combustible materials can generate sufficient vapor to cause a fire in the presence of an ignition source. They are categorized based on flash point--the minimum temperature at which a liquid gives off vapor in sufficient concentrations to allow the substance to ignite.

As of 2012, OSHA’s Hazard Communication Standard revised the criteria to determine the flammability hazard and does not use the term “combustible” (however, the term flammable and combustible are both used in other OSHA regulations).  These categories are what will be listed on chemical labels and safety data sheets to convey hazard information. According to these criteria below, the lower the liquid’s flash point, the higher the degree of flammability.  This was the case before 2012 as well but the new criteria creates the 4 new categories of flammability shown below.  You can see that Category 1 has the highest degree of flammability (and therefore hazard) and Category 4 the least.

Category Criteria
1 Flash point < 23˚C (73.4˚F) & initial boiling point ≤ 35˚C (95˚F)
2 Flash point < 23˚C (73.4˚F) & initial boiling point > 35˚C (95˚F)
3 Flash point ≥ 23˚C (73.4˚F) & ≤ 60˚C (140˚F)
4 Flash point > 60˚C (140˚F) & initial boiling point ≤ 93˚C (199.4˚F

OSHA Category 1 flammable liquids, with the highest degree of flammability, are ignitable at concentrations of <13% by volume at ambient temperatures OR have wide flammable concentration ranges of at least 12 percentage points. For comparison, these chemicals will also be rated with a red 3 or 4 on the NFPA hazard diamond.

Hazards

The liquid does not itself burn; it is vapors from the liquid that burn. The rate of vapor generation depends upon the liquid's vapor pressure, which increases with temperature. The degree of fire hazard depends upon the ability of vapors to mix with air to form combustible or explosive mixtures and the ease of ignition of these mixtures.

Category 1 Flammables are more hazardous because they are more volatile than the other Categories. Safe handling procedures are based upon controlling one or more of the elements necessary to initiate a fire: fuel, ignition source, and oxygen.

Flammable solids may cause fire by friction, absorbing moisture, spontaneous chemical change, retention of heat, or being easily ignited and burning in such a way to cause a serious hazard.

Precautions

  1. Eliminate ignition sources such as open flames, smoking materials, hot surfaces, sparks from welding or cutting, operation of electrical equipment, and static electricity.
  2. Minimize the quantity kept in work area.
  3. Store in approved flammable liquid containers (safety cans) and storage cabinets or in a special storage room designed for that purpose. Store away from oxidizers.
  4. Flammable liquids stored in glass containers shall not exceed one quart unless chemical purity must be protected. In that case one gallon is permissible.
  5. Refrigerators and freezers used for storage of flammables shall be explosion safe and labeled as such.
  6. Assure proper bonding and grounding when transferring or dispensing flammable liquid from a large container.
  7. Assure appropriate sprinklers or fire extinguishers are in the area.

10.5 Corrosives

A corrosive chemical is one that causes visible destruction or irreversible alterations of living tissue by chemical action at the site of contact. They can be in solid, liquid or gaseous form and act on body tissues by direct contact, inhalation or ingestion. Corrosives can be categorized as strong acid, strong base, dehydrating agent, oxidizing agent, or water-reactive. Corrosive liquids are responsible for most corrosive-based injuries. Corrosive gases are the most serious because they can be readily absorbed into the body by dissolution with skin moisture and by inhalation.

Precautions

  1. Eye protection and gloves should always be worn when handling corrosive materials. A faceshield, rubber apron, and rubber boots may also be appropriate; depending upon work performed (check safety data sheet for personal protective equipment requirements).
  2. Always add acid to water. Dehydrating agents such as sulfuric acid, sodium hydroxide, phosphorus pentoxide, and calcium oxide should be mixed with water by adding the agent to water to avoid violent reaction and splattering.
  3. An eyewash and safety shower must be readily accessible to areas where corrosives are used and stored as specified in OSHA 1910.151(c). In the event of skin or eye contact with corrosives, immediately flush the area of contact with cool water for 15 minutes and remove all affected clothing. Get medical help immediately.
  4. Strong oxidizing agents such as chromic and perchloric acids should be stored and used in glass or other inert containers (preferably unbreakable); corks and rubber stoppers should not be used.
  5. Safety rubber bottle carriers or non-breakable bottles (PVC-coated) should be used for the transport of strong acids and bases from one location to another.

Storage

  1. Containers and equipment used for storage should be corrosion resistant.
  2. Acids and bases should be stored separately. Strong oxidizing acids should be stored separately from other acids and bases.

10.6 Compressed Gases

Defin​ition

"Compressed Gas" is a generic term frequently used for different types of gas products, compressed gases, liquefied gases, refrigerated liquefied gases, and dissolved gases. OSHA classification criteria for gases under pressure include:

Compressed Gas -  A gas which when under pressure is entirely gaseous at -50°C (-58°F), including all gases with a critical temperature1 ≤ 50°C (-58°F).

Liquefied Gas - A gas which when under pressure is partially liquid at temperatures above -50°C (-58°F). A distinction is made between:

  1. High pressure liquefied gas: a gas with a critical temperature between -50°C (-58°F) and +65°C (149°F); and
  2. Low pressure liquefied gas: a gas with a critical temperature above +65°C (149°F).

[The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the degree of compression.]

Refrigerated Liquefied Gas [also known as Cryogenic liquids (cryogens)]- A gas which is made partially liquid because of its low temperature.

Dissolved gas - A gas which when under pressure is dissolved in a liquid phase solvent.

Hazards

Compressed gases may be grouped into different hazard categories based upon their physical or health properties, or both. Any gas could be placed into more than one category. A gas could be corrosive, flammable, toxic, an oxidizer, or act as an asphyxiant by displacing oxygen. An additional hazard is due to the fact that gases are stored under high pressure.

Cryogens create unique hazards including fire, pressure, embrittlement of materials, and skin or eye burns upon contact with the liquid. Cryogens condense oxygen from air creating an oxygen rich atmosphere and increasing potential for fire if flammable or combustible materials and an ignition source are present. Pressure is a hazard because of the large expansion ratio from liquid to gas, causing pressure build up in containers. Many materials become brittle at extremely low temperatures. Brief bodily contact with materials at extremely low temperatures can cause burns similar to thermal burns.

Precautions

  1. Never drop cylinders or permit them to strike each other violently.
  2. The valve-protection cap should be left on each cylinder until it has been secured against a wall, bench, or placed in a stand and is ready to be used.
  3. Avoid dragging, rolling, or sliding cylinders, even for a short distance. Use a cylinder hand truck to move them.
  4. Never tamper with safety devices in valves or cylinders.
  5. No part of a cylinder should be subjected to temperatures higher than 125° F. A flame should never be permitted to come in contact with any part of a compressed gas cylinder.
  6. Do not store full and empty cylinders together. Serious suck-back can occur when an empty cylinder is attached to a pressurized system.
  7. Bond and ground all cylinder, lines, and equipment used with flammable compressed gases.
  8. Use compressed gases only in well-ventilated areas. Toxic, flammable, and corrosive gases should be handled in a hood. Only small cylinders of toxic gases should be used.
  9. When discharging gas into a liquid, a trap or suitable check valve should be used to prevent liquid from getting back into the cylinder or regulator.
  10. When returning empty cylinders, close the valve before shipment, leaving some positive pressure in the cylinder. Replace any valve outlet and protective caps originally shipped with cylinder. Mark or label cylinder "empty" and store in a designated area for return.
  11. Before using cylinders, read all label information and safety data sheets associated with the gas being used. Check the SDS for required personal protective equipment and hazard Information before use.
  12. For flammable cryogens the precautions detailed in Procedures for Handling Flammable and Combustibles should be followed.
  13. When handling cryogens always wear safety goggle. If there is a splash or spray hazard, personnel protective clothing should also include a face shield, impervious apron or coat, trousers without cuffs, and shoes that cover the foot. Gloves should be impervious.
  14. Containers and systems containing cryogens should have pressure relief mechanisms.
  15. Containers and systems should be capable of withstanding extreme cold without becoming brittle.

Resource

Compressed Gas Safety Guide

10.7 Peroxide Formers

Definition

Peroxide formers, or peroxidizables, are materials which react with oxygen to form peroxides which can explode with impact, heat, or friction.

Hazard Categories

Peroxide-forming compounds can be divided into three hazard categories. Storage times are based on time after opening the container. Most chemicals will have an expiration date on the chemical label based on the type of chemical. Examples are shown below.

  1. Compounds forming peroxides that can spontaneously decompose during storage.
    • Maximum storage time is 3 months. Examples include divinyl acetylene, isopropyl ether, potassium metal, sodium amide, vinylidene chloride.
  2. Compounds forming peroxides that require the addition of a certain amount of energy (distillation, shock) to explosively decompose.
    • Maximum storage time is 12 months. Examples include acetyl, cyclohexene, diacetylene, dicyclopentadiene, diethyl ether, dioxane, 1,2-dimethoxyethane, methyl acetylene, methyl cyclopentane, methyl isobutylketone, tetrahydrofuran, vinyl ethers, tetrahydronaphthalene.
  3. Compounds that have the potential to form peroxide polymers, a highly dangerous form of peroxide which precipitate from solution easily and are extremely heat and shock-sensitive.
    • Maximum storage time is 12 months. Examples include acrylic acid, acrylonitrile, butadiene, chloroprene, chlorotrifluoroethylene, methyl methacrylate, styrene, tetrafluoroethylene, vinyl acetate, vinyl chloride, vinyl pyridine.

Precautions for Peroxide-Formers

All labs should actively manage peroxide-forming chemicals. Utilize the following practices:

  1. Date all peroxidizables upon receipt and opening. Unless the manufacturer has added an inhibitor, materials should be disposed of in a timely manner.
  2. Periodically test contents for peroxides using peroxide test strips; record test date and results on container.
  3. Do not open any container with evidence of peroxide formation such as obvious crystal formation around the lid or in the liquid, or visible discoloration.
  4. Keep peroxide-forming chemicals in their original containers to minimize conditions that accelerate peroxide formation.
  5. Other precautions are similar to those used for flammables.

Resources

10.8 Reactive Chemicals

​Defini​tion and Hazards

The category "Reactive" is a term given to a chemical class that displays a broad range of reactions. This category includes explosives, oxidizers, reducers, water sensitive, acid sensitive, air sensitive and unstable chemicals. These substances are capable of producing toxic gases, explosive mixtures, being explosive, reacting with water violently, or they may contain cyanide or sulfide. Reactive chemicals exhibit moderate to extremely rapid reaction rates and include materials capable of rapid release of energy by themselves (self-reaction or polymerization), and/or rates of reaction that may be increased by heat or pressure or by contact with incompatible substances.

Reactives may be broadly classified into two groups: those that may explode and those that do not. Reactivity of individual chemicals in specific chemical classes (e.g., alkali metals) varies considerably. This rate of activity may also vary as a result of aging or contamination. Reactives may be further subdivided and placed into eight classes based upon their chemical behavior.

Cl​ass I

Chemicals normally unstable that readily undergo violent change without detonating.

Properties -

  1. Pyrophorics--spontaneous ignition in contact with air. Examples: metal alkyls, phosphorus, finely divided metal powders such as magnesium, aluminum, and zinc. Prevent contact with air or water - use and store in inert environments.
  2. Polymerizables--spontaneous polymerization in contact with air. Examples: divinyl benzene. Keep cool and avoid contact with water.
  3. Oxidizers--violent reaction in contact with organic materials or strong reducing agents. Examples: perchloric, chromic and fuming nitric acid. Use minimum amounts for procedure; do not keep excessive amounts of material in the vicinity of process; store properly, away from organic materials, flammable materials and reducers.

Class II

Chemicals that react violently with water.

Properties –

Causes large evolution of heat in contact with water, decomposes in moist air, and violently decomposes with liquid water. Examples: Sulfuric acid, chlorosulfonic acid, oleum, phosphorous trioxide and pentoxide, acetyl halides, phosphorus halides, titanium tetrachloride, glyoxal.

Precautions

  1. Handle materials like corrosives. Use protective acid resistant rubber or plastic clothing with gloves and face shield.
  2. Keep away from moisture.
  3. Handle materials in fume hood since fuming in moist air can result in exposure to corrosive and/or toxic gases

Class III

Chemicals that form potentially explosive mixtures with water.

Properties –

Chemicals decompose violently in water with evolution of heat and flammable gases, which may ignite if exposed to ignition source. Evolution of heat with water may be sufficient to cause auto-ignition (and explosion). Examples: alkaline metals, alkaline earth metals, alkaline metal hydrides, alkaline metal nitrides.

Precautions

  1. Provide ventilation to disperse flammable gases.
  2. Use dry sand to smother materials - use of water as a fire extinguisher may aggravate fire.
  3. Avoid contact with and handle away from water sources.

Class IV

Chemicals that, when mixed with water, generate toxic gases, vapors or fumes in quantity sufficient to present a danger to human health or the environment.

Properties –

Reacts rapidly with water with the production of gases or vapors, which are acutely toxic to human health. Examples: alkaline metal phosphides, phosphorus halides, aluminum phosphide, toluene diisocyanate.

Precautions

  1. Provide adequate ventilation when handling.
  2. Keep containers sealed.
  3. Do not handle near water.

Class V

Cyanide or sulfide bearing chemicals.

Properties –

Acid sensitive cyanides and sulfides that produce extremely toxic hydrogen cyanide or hydrogen sulfide gases on contact with acids or materials which form acids in the presence of moisture or liquid water.

Examples: metal cyanide salts, organic cyanide compounds, metal sulfide salts, organic sulfides and mercaptans.

Precautions

  1. Do not store in cabinets with acids and oxidizers.
  2. Isolate from other reactive chemicals.
  3. Protect sulfide salts from moisture.
  4. Provide adequate ventilation due to severe inhalation hazard of hydrogen cyanide and hydrogen sulfide and acute toxic effects from skin contact with hydrogen cyanide.

Class VI

Chemicals capable of detonating or exploding if subjected to a strong initiating source or if heated under confinement.

Properties –

Detonation or explosion can occur if heated above ambient temperature; or if exposed to an initiating source such as shock, mechanical shock, spark or flame, or a catalyst that accelerates decomposition. Examples: lead amide, sodium amide, thallous nitride, metal azides, brominated organic compounds, benzene diazonium salts, ammonium picrate, ammonium tetra-chromate, metal periodates, organic perchlorates, isoamyl nitrite, ammonium nitrate & chlorate.

Precautions

  1. Protect containers from physical damage, heat and incompatible chemicals.
  2. Chemicals in this class exhibit a wide range of other properties, i.e., flammability, acid or water or light sensitivity. Know the properties of the materials being worked with.
  3. Check SDS for information on incompatibles when storing.

Class VII

Chemicals readily capable of detonation, explosive decomposition, or reaction at standard temperature and pressure.

Properties –

Chemicals capable of detonation or explosive decomposition under ambient temperature and pressure without any external initiating source. Examples: ammonium chlorate, organic azides, metal azides, benzoyl peroxide, peroxidized ethers.

Precautions

  1. Materials should only be handled by knowledgeable and trained individuals.
  2. Evaluate chemicals periodically to determine whether deterioration has occurred. If so, dispose of properly by contacting Environmental Health & Safety.
  3. Check the SDS for information on incompatibles for storage and chemical properties of materials handled.
  4. Follow recommendations on SDS for personal protective equipment.

Class VIII

Forbidden explosives, Class A explosives, and Class B explosives as defined in 49 CFR 173.

Properties –

Forbidden Explosives are capable of detonation or explosive decomposition under ambient conditions, considered too dangerous for transportation. Examples: Forbidden explosives: diethylene glycol dinitrate, unstabilized nitroglycerine, nitrocellulose. Class A Explosives: TNT, mercury fulminate, diazo-dinitrophenol, lead 2,4-dinitroresorcinate. Class B. Explosives: stabilized nitrocellulose, stabilized nitroglycerin.

Precautions

Materials should only be handled by experienced and properly equipped persons.

Resource

Pyrophoric Reagents Handling in Research Labs

 

11.0 Shipping Regulations

IATA (International Air Transport Association) and DOT (Department of Transportation) regulate the shipping of infectious substances and diagnostic specimens.  Specific requirements regarding the classification of agents, package preparation, package marking/identification and shippers declaration have been established.  It is the shipper’s responsibility to be aware and to adhere to applicable laws, regulations and requirements.  

11.1 General Precautions

  1. Maintain a list of hazardous chemicals used or stored.
  2. Assure all containers are in good condition and properly labeled.
  3. Review stored items at least yearly, more frequently for age-sensitive materials. Ensure containers and caps are in good condition. Ensure materials are stable.
  4. Do not store chemicals in alphabetical order unless they are already segregated by hazard category.
  5. Do not store incompatible chemicals in close proximity to each other.
  6. Avoid floor chemical storage.
  7. Provide anti-roll lips on shelves.
  8. Provide shelving that can be cleaned and won't soak up spilled chemicals.
  9. Store chemicals below eye level.
  10. Do not store chemicals on top of shelving units or on top of flammable storage cabinets.
  11. Avoid use of adjustable supports with clips.
  12. Store severe poisons in a dedicated cabinet.
  13. Store oxidizing acids in secondary containers.
  14. Label storage areas by chemical group.
  15. Store flammable liquid quantities over 10 gallons in flammable storage cabinets. See also storage procedures for flammable and combustible liquids.

11.2 Flammable and Combustible Liquids

  1. Maintain a list of hazardous chemicals used or stored.
  2. Assure all containers are in good condition and properly labeled.
  3. Review stored items at least yearly, more frequently for age-sensitive materials. Ensure containers and caps are in good condition. Ensure materials are stable.
  4. Do not store chemicals in alphabetical order unless they are already segregated by hazard category.
  5. Do not store incompatible chemicals in close proximity to each other.
  6. Avoid floor chemical storage.
  7. Provide anti-roll lips on shelves.
  8. Provide shelving that can be cleaned and won't soak up spilled chemicals.
  9. Store chemicals below eye level.
  10. Do not store chemicals on top of shelving units or on top of flammable storage cabinets.
  11. Avoid use of adjustable supports with clips.
  12. Store severe poisons in a dedicated cabinet.
  13. Store oxidizing acids in secondary containers.
  14. Label storage areas by chemical group.
  15. Store flammable liquid quantities over 10 gallons in flammable storage cabinets. See also storage procedures for flammable and combustible liquids.

Flammable and combustible liquids classification graphic

Procedures

The following storage requirements apply to most university academic and research buildings. For flammable storage vaults, warehouses, and industrial operations, contact EHS (335-8501) as other requirements may apply.

Whenever possible, flammable liquids should be placed in storage cabinets.

Maximum quantity of Class IA, IB and IC flammable liquids, in any combination, in a fire area (room with approved walls and doors) outside of approved storage cabinets or safety cans is 10 gallons.

Maximum quantity of Class II, Class IIIA and IIIB combustible liquids, in any combination, in a fire area (room with approved walls and doors) outside of approved storage cabinets or safety cans is 30 gallons.

For maximum amount of Class IA, IB and IC flammable liquids in any combination, in a fire area (room with approved walls and doors) that can be stored inside approved storage cabinets or safety cans please contact either Richard-byrum@uiowa.edu 335-9379 or Rachelle-justice@uiowa.edu 353-4692.

12.0 Safety Training

Departments must provide employees with information and training in order to ensure that they are apprised of biohazards in their work area.  Training may take the form of individual instruction, group seminars, audiovisual presentations, handout material or any combination of the above.  Training should include the specific hazards associated with agents in the work area when generic training is insufficient to address specific hazards. 

Training should be provided at the time of an employee's initial assignment to a work area where biohazardous agents are present and prior to assignment involving new exposure situations.  Employees should receive periodic refresher information and training.  All training must be documented (see below). 

Information and training provided by departments should include: 

  • the location and availability of the written Biological Safety Manual; 
  • the health hazards, signs and symptoms associated with exposures and infections from biohazardous agents used in the work area;
  • the measures employees can take to protect themselves from these hazards, including specific procedures the University or department has implemented such as appropriate work practices, emergency procedures and personal protective equipment; and
  • the location and availability of reference material on the hazards, safe handling, storage and disposal of biohazardous agents. 

Although students are not covered under IOSH (Iowa’s Occupational Safety and Health Administration), they should be aware of biohazards in teaching situations and be provided information and equipment to protect themselves from those hazards.  Departments should provide student training at the beginning of each course in which biohazardous agents are used, with specific safety instructions provided at the beginning of each class period. 

Departments are responsible for insuring that their employees and students receive the proper training as stipulated in the Biosafety Manual.  Online, web-based courses are currently available for all training courses through EHS’s Web site.  EHS provides training courses in the following areas:

  • Biological Safety
  • Chemical Safety
  • Ergonomics
  • General Safety
  • Hazardous Waste Management
  • Industrial Hygiene
  • Radiation Safety including Laser Safety

13.1 Basic Steps for Emergencies, Major Spill, and Other Problems

Any Emergency – Call 911

Fire, Explosion, Police, Ambulance, Rescue, Evacuation

Major Spill - Call 911

A major spill is one that is spreading rapidly presents inhalation or fire hazards, has entered the environment, or exceeds the capability of the user to respond.

  • Alert others to leave spill area.
  • Remove ignition sources, shut down equipment, close fume hood sash, open
  • windows, as appropriate.
  • Close doors to room.
  • Assemble at a safe distance and location.
  • Wait and provide information to Emergency Responders.

Personal Injury

Body or Eye Splashes

  • Assist person with use of body shower and/or eye wash equipment.
  • Flush body and/or eyes with water for at least 15 minutes.
  • Remove contaminated clothing while under body shower.
  • Wash skin with mild soap and water - do not use neutralizing agents, creams, lotions or salve.
  • Seek medical attention.

Medical Treatment Needs

Emergencies

Report to UIHC Emergency Treatment Center (24 hours, 7 days).

Vehicle Transport Assistance

If needed, call Department of Public Safety, 335-5022.

Non-emergency work-related needs

During normal business hours, call or check with UI HealthWorks (319-665-2111) located on Highway 965 in North Liberty.

Inhalation Hazards

Rescue or Evacuation

Call 911

Non-emergency evacuation

Call 335-5022, Department of Public Safety

Non-emergency technical assistance

Call 335-8501, Environmental Health & Safety.

Radioactive Materials Notification

Notify EHS of all radioactive materials spills and instances of personal contamination without delay. During normal business hours call 335-8501. After hours call Department of Public Safety at 335-5022.

Note: Radioactive materials spill response procedures must be developed and readily available to personnel. Consult The University of Iowa’s “Radiation Protection Guide for Radioactive Materials Use in the Basic Sciences” or contact EHS when developing radioactive materials emergency and spill response information pertinent to your lab, or call 335-8501.

Environmental Release and Oil Spill Notifications

For suspect or known s to the environment (air, water, land, drains) notify the Environmental Health & Safety or Environmental Compliance Manager during regular business hours. After hours call Department of Public Safety at 335-5022 for non-emergencies or 911 for emergencies. Notifications must be made to regulatory agencies immediately and not later than six hours for actual or suspect environmental releases.

Power Outages

Contact Work Control Center 335-5071 (24 hours/7 days)

  • Place lids on open containers of volatile chemicals.
  • Lower the sash on chemical fume hoods.
  • Turn off ignition sources.
  • Shut down equipment (leave cooling water, purge gases on as necessary).
  • Secure or isolate reactions that are underway (boiling liquids, distillations).

13.2 Preparing Spill Plans

  • Review your Chemical List to identify hazards of chemicals used and stored in your area.
  • Purchase or assemble a spill kit appropriate for your chemicals. Consider special needs for air and water reactives, poisons, and hydrofluoric acid.
  • Post Emergency Contact Information or call lists at the entrance to the area.
  • Post the Hazardous Materials Spill Guide at an easily accessible location in the work area, e.g., near the telephone.
  • Train lab occupants on area spill procedures.

13.3 Spill Kit Supplies

A list of spill supplies is available at University Biochemistry Stores. Pre-assembled kits are available that can be customized with the necessary neutralizers, etc. for your specific lab needs. Supplies are also available from lab and safety catalogs.

Basic Kit Supplies:

  • Chemical Resistant Container for Kit
  • Universal Absorbents
  • Goggles, Gloves
  • Disposable Coverall or Apron
  • Shoe Covers
  • Dust Pan and Whisk Broom for Solids
  • Hazardous Waste Labels

Add as needed in your area:

  • Personal Protective Equipment such as face shields, aprons, boots.
  • General neutralizing agents such as sodium bicarbonate for acids, and citric acid or sodium bisulfate for bases.
  • Agent specific neutralizers available for acids, bases, formaldehyde and solvents.
  • Mercury collection sponges.
  • Specialized supplies for air or water reactive chemicals and Hydrofluoric Acid.
  • Only add respirators if additional training and program requirements have been met.

Resource

Spill Response Guide: Spill Kits, Absorbents and Neutralizers

13.4 Spill Training

Spill Training for your area should include:

  • Recognition (sight, smell, alarms, etc.)
  • First aid for chemical injuries that may occur in your area
  • Handling emergencies (notification, action)
  • Prevention/Containment (secondary containment, spill limitation)
  • Clean-up (personal protection, use of equipment, preventing damage, etc.)
  • Packaging and handling of residue.

Resource

ICON Spill Preparedness and Response Course - W142CM

13.5 How to Prevent and Minimize Spills

  • Store hazardous liquid containers in a pan or tray big enough to hold the contents if the container breaks or leaks.
  • Buy liquids in plastic coated bottles.
  • Use bottle carriers for protection and containment.
  • Put pans under experiments.
  • Use traps on vacuum lines.
  • Use carts designed to prevent materials from sliding off the cart.
  • Have sink stoppers and drain covers handy to prevent material from entering drains.

Tip: Use the Spill Response Quick Guides as training tools for the lab (see Resource for 13.6 Spill Clean-up Procedures below).

13.6 Spill Clean-up Procedures

Sm​all, Simple Spills

A simple spill is not spreading rapidly, does not endanger people or property except by direct contact, and does not endanger th​e environment outside of the building. Users of chemicals are able to neutralize, absorb or otherwise manage small spills. If there are questions about safe or appropriate clean up measures check first with your supervisor or EHS.

General Clean Up Procedures

  1. Refer to the Concise Hazardous Material Spill Response Guide if needed (see Resource for this section).
  2. Always wear eye and hand protection and choose additional protective equipment appropriate for the situation.
  3. Contain the spill. Gently apply absorbent from the outer edge of the spill in.
  4. For solids gently brush particles into a container or dustpan. If spill is not water reactive material, wet wipe the area.
  5. Deposit hazardous debris in a rigid non-reactive container with a lid.
  6. If debris may off gas, place the container in a chemical fume hood. Open the lid slightly to avoid pressure buildup or container rupture.
  7. Complete hazardous waste label and request container pickup.

Mercury

For small spills such as a thermometer, use an aspirator bulb, suction device or mercury sponge. Place debris in a sealed rigid container, not a plastic bag. If vapor inhalation is a potential problem, i.e., larger spills, spills in small unventilated spaces, or spills in ovens or heating baths, contact EHS.

Ac​id Chlorides

Avoid water and sodium bicarbonate. Use dry sand, Oil-Dri, or an equivalent product.

Alkali Metals

Do not use water. Smother in dry sand and place debris in a hood.

Highly Hazardous or Toxic Materials

Certain substances such as hydrofluoric acid or extremely poisonous substances may necessitate having special clean up supplies or antidotes in the work area.

Resource

14.0 Accident Reporting

Refer to Section 34.2 of the University Operations Manual for the complete policy. The main requirements are:

  • All injuries must be reported immediately by the injured employee to his/her supervisor.
  • The supervisor must submit the First Report of Injury Form within 24 hours. This form is available through HR Employee Self-Service. Late forms are assessed penalty charges which are passed back to the department in which the incident occurred. Questions on the form or claim should be directed to Staff Benefits Office.

Supervisors and/or departments should investigate the cause or causes of incidents to prevent reoccurrence. Contact the Environmental Health & Safety for assistance if needed. Follow-up should be done by the department to ensure that corrective action has been taken.

Departments may request an accident/incident summary for their area from the Environmental Health & Safety. This summary includes the incident date, type and description, name, occupation, and days lost.

15.0 Record-Keeping Requirements

Records of monitoring measurements or any medical consultation or examinations, including tests or written opinions, must be maintained for each employee. Such records must be kept, transferred, and made available in accordance with 29 CFR 1910.1020 and, as applicable, record requirements in other select OSHA standards.

16.0 Lab Health and Safety Review Program

EHS maintains a Safety Advisor Team Program to support research labs by providing consultation, education, and services to enhance safety and health compliance and practice.  This team conducts annual reviews of research laboratories.  Information about the Safety Advisor Team and the Annual Lab Review programs can be located in the resource below.  The resource describes the program and provides links to the topics that EHS reviews during each visit.

Resource

EHS Safety Advisor Team Program

17.0 Laboratory Close-out Procedure

Procedures have been developed to assist with the process of closing down a laboratory or moving to another laboratory location.  These procedures are designed to assure that the space is cleared of hazardous equipment and materials and the laboratory facility is left in a safe condition when the space is vacated.  The procedures provide information about various categories of hazardous materials, a step-by-step timeline for when activities should be conducted, forms used to implement the process, and contacts to assist with the process.

 

Resource

Laboratory Close-out Procedure

2.0 Abbreviations

Presented below is a listing of the abbreviations found throughout this manual.

ABSA

American Biological Safety Association

ABSL

Animal Biosafety Level

APHIS

Animal and Plant Health Inspection Service

ARO

Alternate Responsible Official

BBP

Bloodborne Pathogens

BMBL

Biosafety in Microbiological and Biomedical Laboratories

BSC

Biological Safety Cabinet (aka Tissue Culture Hood/Cabinet)

BSL

Biosafety Level

BSO

Biological Safety Officer

CDC

Centers for Disease Control and Prevention

CFR

Code of Federal Regulations

DHHS

Department of Health and Human Services

DNR  

Department of Natural Resources

DOT 

Department of Transportation

DPS   

Department of Public Safety (UI Police Department)

EHS  

Environmental Health & Safety Office

ETC 

Emergency Treatment Center

FBI 

Federal Bureau of Investigation

FM 

 Facilities Management

GMT 

Good Microbiological Techniques

HEPA

High Efficiency Particulate Air

HHMI

Howard Hughes Medical Institute

IACUC

Institutional Animal Care and Use Committee

IATA

International Air Transport Association

IBC 

Institutional Biosafety Committee

IRB

Institutional Review Board

IOSH

Iowa Occupational Safety and Health Administration

MSDS

Material Safety Data Sheet

NCI 

National Cancer Institute

NIH  

National Institutes of Health

NSF   

National Sanitation Foundation

OBA    

Office of Biotechnology Activities

OSHA  

Occupational Safety and Health Administration

OPIM

Other Potentially Infectious Materials

PI 

Principal Investigator

PPE   

Personal Protective Equipment

ppm  

parts per million

RAC  

Recombinant DNA Advisory Committee

rDNA  

Recombinant DNA

RG

Risk Group

RO   

Responsible Official

SOP

Standard Operating Procedure

UEHC

University Employee Health Clinic

UIHC   

University of Iowa Hospitals and Clinics

UIRIS   

University of Iowa Research Information System

USDA   

United States Department of Agriculture

USPS  

United States Postal Service

UV 

Ultra-violet

WHO  

World Health Organization

 

5.2 Contractor Management

Environmental Services or any other University or UIHC department that is managing contractors or conducting activities that may disturb lead-containing materials shall implement exposure control procedures.

5.3 Deans, Directors and Department Heads Responsibilities

Deans, Directors and Department Heads are responsible to provide oversight of department activities to ensure compliance with exposure control procedures. Day to day oversight may be assigned to a Department Lead Program Administrator.

6.0 Biosafety Level Criteria

Four biosafety levels have been defined that consist of specified lab practices and techniques, safety equipment and lab facilities.  These are commensurate with the operations performed and with the hazard potential posed by the biohazardous agents with which the laboratory works. 

The reference for this section is the BMBL (Biosafety in Microbiological and Biomedical Laboratories), 5th Edition, 2007, U.S. Department of Health and Human Services.  Described below are Biosafety Levels 1 through 3.  Biosafety level 4, the maximum containment lab, described in the BMBL is not included in this manual, as facilities do not presently exist at the University that would accommodate the safety regulations involved with Level 4 work.   Table 4 presents a summary of the different biosafety level requirements.

7.0 Animal Biosafety Level Criteria

These guidelines describe three combinations of practices, safety equipment and facilities for experiments on animals infected with agents that produce or may produce human infection.  They provide increasing levels of protection to personnel and the environment and are recommended as minimal standards for activities involving infected laboratory mammals.  These three combinations are designated in each of the ABSL (Animal Biosafety Levels) 1 through 3 and describe animal facilities and practices applicable to work on animals infected with agents assigned to corresponding BSL1 through 3. 

The reference for this section is the BMBL, 5th Edition, 2007, U.S. Department of Health and Human Services.  See Appendix Q of the NIH Guidelines for additional requirements specific to large animals involved in research with rDNA.

7.1 Exposure Assessments

The purpose of an assessment is to determine if there was an exposure that might have caused harm to lab employees and to identify the chemical(s) involved. Exposure assessments may include interviews with the affected employee(s) and laboratory staff, air monitoring, evaluation of laboratory controls and protective equipment, and medical consultation and examination.

When to suspect overexposure:

  • If an employee manifests symptoms such as headache, rash, nausea, coughing, tearing, irritation or redness of the eyes, irritation of the nose or throat, dizziness, loss of motor dexterity or judgment, etc. and:
    • Some or all of the symptoms disappear when the employee is removed from the exposure area.
    • The symptoms reappear soon after the employee returns to work with the same hazardous chemicals.
  • Two or more persons in the same laboratory work area have similar complaints.
  • A hazardous chemical leaked, spilled or was otherwise rapidly released in an uncontrolled manner.
  • A laboratory employee had direct skin or eye contact with a hazardous chemical.

Note: Odor is not a means of determining exposure levels. If there is reason to suspect that a chemical exposure limit has been exceeded notify the lab supervisor whether or not a suspicious odor is involved.

7.2 Air Monitoring

Contact Environmental Health & Safety at 335-8501 to request air monitoring to evaluate chemical exposures. Upon completion of monitoring, employees must be notified of results in writing either individually or by posting, within 15 days, of the receipt of results. Records of monitoring results and employee notification must be kept, transferred, and made available in accordance with 29 CFR 1910.1020. If exposures are found to be over legal limits further action will be required.

7.3 Medical Services

Medical services may consist of a medical consultation, examination, or emergency services. Pre-exposure (baseline) assessment is available upon departmental request at the University Employee Health Clinic. There is no cost to the employee for these services and employees may be medically monitored on an annual basis.

When assessment results indicate that an employee may have been exposed to a hazardous chemical, the employee should obtain a medical consultation from the UI HealthWorks in North Liberty (319-356-3335 or 800-327-5605). Consultations and examinations must be under the direct supervision of a licensed physician. The employing lab or department must inform the physician of the identity of the chemical, the conditions of the exposure, and the employee's symptoms. A written opinion must be obtained from the physician. It must be maintained as a part of the employee's record and made readily available to the employee and upon request to his/her designated representative. The written opinion must not reveal findings unrelated to occupational exposure.

The written opinion must include:

  1. Follow-up recommendations.
  2. Exam and test results.
  3. Any medical condition found as a result of the exam that may place the employee at an increased risk as a result of hazardous chemical exposure.
  4. A statement that the employee has been informed by the physician of the results of the consultation.

Additional information about seeking treatment for work related injuries is presented in section 13.1 Basic Steps for Emergencies, Major Spill, and Other Problems.

7.4 Exposure and Medical Records

Records of monitoring measurements or any medical baseline, consultation or examination, including tests or written opinions, must be maintained for each employee for a period of thirty years after retirement or resignation. Records must be kept, transferred and made available in accordance with 29 CFR.1910.1020.

8.0 Disinfection and Sterilization

Routine cleaning of the laboratory is required to maintain a sanitary, safe working environment.  Several different means of decontamination exist and the method you choose will depend on the type of experimental work and the nature of the infectious agent(s) present.  Of note, prions are highly resistant to inactivation by most physical and chemical agents; decontamination of prions will be addressed separately in this chapter.  Standard procedures should be established for each laboratory, designed to meet the needs of the various levels of biohazards found in your particular lab.

8.1 Exposure Controls

Potential exposure should be maintained at the lowest practical level and must not exceed legal exposure levels. OSHA requires engineering controls as the primary means of worker protection. A common engineering control in the laboratory is the chemical fume hood. Administrative controls such as safe work practices and personal protective equipment are other exposure controls common in labs.

8.2 Routine Safety Practices in Labs

  1. Post entrances with emergency contact information.
  2. Be aware of the location and proper operation of laboratory safety equipment.
  3. Dress appropriately in the lab. Apparel should include full foot coverings and clothing that covers the skin. Perforated shoes and sandals should not be worn in laboratories. Loose, skimpy or torn clothing should not be worn in laboratories.
  4. Wear lab coats and gloves in lab areas only, not in public areas.
  5. Do not eat, drink, or apply cosmetics in chemical use areas. Smoking is not allowed in University buildings.
  6. Ice, glassware, utensils, ovens, refrigerators, and other equipment used for lab operations should not be used for storage, handling or consumption of food and beverages.
  7. Wash hands before using the restrooms and before eating or smoking.
  8. Keep access route to exits, emergency equipment and utility controls open and unblocked.
  9. Keep lab areas clean and uncluttered to help prevent unnecessary contact or personal injury from breakage and spillage of chemicals.
  10. Keep lab doors closed for fire safety and to maintain proper room air pressures.
  11. Visitors to the lab are to be escorted by an employee and are the responsibility of that employee.

8.3 Personal Protective Equipment

Proper use of Personal Protective Equipment (PPE) will minimize exposure to hazards associated with many laboratory operations. PPE should satisfy performance requirements such as strength, chemical resistance and thermal resistance without inhibiting flexibility and manual dexterity.

PPE shall be selected, used, and maintained in accordance with applicable IOSH Standards and as described in EHS’s “Personal Protective Equipment Procedures.” This PPE compliance guide contains resources for completing the required Certification of Hazard Assessment and Training for employees. A Research Laboratory Hazard Assessment Tool for Personal Protective Equipment Use is included in this guide.  This tool provides a step-by-step approach to completing a PPE hazard assessment and completing required training at the laboratory level.

Skin Protection

In addition to personal protective equipment, lab workers should plan to keep skin covered when working at the bench with hazardous materials.  Skin coverage includes use of lab coats, long pants or skirts covering the legs, and closed-toe and closed-heel shoes to cover the feet.

Reusable protective clothing such as lab coats should be laundered on a regular basis to maintain hygiene. Laundering should be completed whenever the lab coat is visibly soiled. The frequency and manner in which lab coats are used, determine how often they should be laundered. Laundering of reusable protective clothing shall be performed by The University of Iowa Laundry Service; laundering may not be done by lab staff members at private residences or public laundry facilities.

Any lab coat/protective clothing known or reasonably suspected to be contaminated with biohazardous material(s) must be decontaminated (i.e. autoclaved or treated with an effective disinfectant) before it is sent to laundry services. If protective clothing will be autoclaved, it must be capable of withstanding high temperatures.  Do not autoclave lab coats that are additionally contaminated with chemical or radioactive materials; dispose of the contaminated clothing as hazardous waste. Additionally, lab coats that become grossly contaminated with biohazardous material(s) should be disposed of as biohazardous waste.

Eye and Face Protection

Eye and face protection shall be required where there is a reasonable probability that injury could be prevented by such protection. PPE shall be selected in accordance with IOSH 1910.133 "Eye and Face Protection" and shall meet requirements specified in American National Standards Institute, Z87.1, "Practice for Occupational and Educational Eye and Face Protection". Eye and face protection can be purchased from laboratory and safety catalogs and University Stores. Prescription safety glasses are purchased through UI Optical with an interdepartmental requisition. Eye examinations and associated costs are the responsibility of the employee.

Note: Protective equipment related to lasers, X-rays, gamma rays, and microwaves, etc. are not covered by the Z87.1 standard. Departments or the user should contact the manufacturer and EHS’s Radiation Protection Section (335-8501) for proper selection.

General eyewear requirements

  1. Safety glasses with permanently attached side shields are required where there is a potential of being struck by projectile objects.
  2. Chemical splash goggles are required in chemical handling operations where protection is needed against mists, aerosols and sprays.
  3. Face shields are required where facial skin protection is needed for chemical or physical agents. Where both eye and face protection is needed, the face shield is used in addition to the safety glasses or goggles.

Hand Protection

Skin contact is a potential source of exposure to toxic materials. Check the Safety Data Sheet for substances that can create exposure routes by skin absorption. Appropriate gloves may be selected based on the requirements listed on the next page and can be purchased from laboratory and safety supply catalogs.

General glove requirements:

  1. Gloves should be worn whenever there is potential for contact with corrosive or toxic materials, or materials of unknown toxicity.
  2. Gloves should be selected based on test data from the glove manufacturer.
  3. Chemicals eventually permeate gloves; however, they can be used safely for limited time periods if specific use and glove characteristics, i.e., thickness, permeation rate and time, are known.
  4. Gloves should be replaced periodically depending on frequency of use and permeability to the substance(s) handled.

Resource

  1. PPE-Glove Selection Information
  2. https://ehs.research.uiowa.edu/ppe-research-laboratory-hazard-assessment-tool

8.4 Inhalation Protection

When a chemical is used in a way that may present an inhalation hazard, measures must be taken to control exposure. This is primarily accomplished in the laboratory through proper use of a chemical fume hood. When procedures cannot be performed in a fume hood or ventilation is not adequate to provide protection against inhalation hazards, respiratory protective equipment may be necessary. Respirators should be the last option chosen for controlling inhalation hazards.

8.5 Respirators

Departments or laboratories that issue, recommend or provide respirators for employee protection are required to implement a respiratory protection program in accordance with IOSH Standard 1910.134. The Environmental Health & Safety or other qualified industrial hygiene services should be contacted for assistance in determining the need for implementation of a respirator program. Respirator program components include hazard evaluations, annual medical evaluations, fit-tests and training for individuals using respirators, and written programs including record keeping and annual reviews.

Even if employees desire to wear a respirator or dust mask for their comfort (such as to minimize odor), a respirator use evaluation is still required.  Contact EHS to request a respirator use evaluation.

Resource

9.0 Research Involving Recombinant DNA

As a condition for NIH funding, all rDNA research conducted at or sponsored by the University, irrespective of the source of funding, must comply with the NIH Guidelines.  The NIH Guidelines defines rDNA as either (1) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or (2) molecules that result from the replication of those described in (1) above.  Non-compliance by a PI may result in (1) suspension, limitation or termination of financial assistance for the noncompliant NIH-funded research project and of NIH funds for other rDNA research at the institution or (2) a requirement for prior NIH approval of any or all recombinant DNA projects at the University.  In order to assure compliance, all PIs working with rDNA need to be familiar with the latest edition of the NIH Guidelines; an online course, NIH Guidelines for Research Involving Recombinant DNA, offered through EHS, has been developed to assist PIs in meeting this obligation. 

9.1 Ventilation

General lab ventilation shall provide airflow into the laboratory from non-laboratory areas and out to the exterior of the building. Laboratory doors should remain closed except for egress and entrance.

Local Exhaust Ventilation equipment is a commonly used engineering control in the lab. Usually this is a chemical fume hood but also includes ventilated bench top cabinets, spot exhaust devices, and filtered cabinets for using hazardous solids.

9.10 Shielding

Safety shielding should be used for any operation having the potential for explosion and must be placed so that all personnel in the area are protected from hazard, such as whenever:

  1. A reaction is attempted for the first time (small quantities of reactants should be used to minimize hazards).
  2. A familiar reaction is carried out on a larger than usual scale (5-10 times more material).
  3. An operation is carried out under non-ambient conditions.

9.11 Gas Hose Connectors

  1. Injection (Bunsen) burners and burner hose/tubing should be routinely inspected and free of defects (cracks, holes, pinched points, etc.).
  2. Before use assure the hose/tubing is securely connected to the gas valve and the burner before use.
  3. Covered flexible metal hoses manufactured for injection burner use are preferable to rubber tubing.
  4. Keep access to gas valves/shut-offs free of obstructions.

9.2 Chemical Fume Hoods

A fume hood is a local exhaust device whose primary purpose is to protect laboratory workers from hazards of airborne chemical contaminants. The secondary purpose is to protect people and property against small fires and explosions. The fume hood must be used properly to allow it to function properly and remove contaminants from the breathing area of the user.

  • Use chemicals in the hood that may generate contaminants near or above exposure limits.
  • Do not have sources of ignition inside the hood when flammable liquids or gases are present.
  • Visually inspect the device (and flow monitor) daily or before each use.
  • Keep all items 6 inches back from the front edge of the hood to avoid blocking the airflow path.
  • Keep slot openings at the back of the hood free from blockage with large objects or numerous containers.
  • Elevate large objects 2 inches off the floor of the hood so air can pass under the object and out the back slots in the hood.
  • Close the sash when the hood is not in use
  • During hood use, lower the sash to the sash arrow sticker, below the chin and more if possible. Lower and use the sash as a safety shield when working with reactive materials or materials that may splatter.
  • Do not store chemicals in hoods.

Resource

9.3 Maintenance and Inspection of Fume Hoods

Operators should check the hood area daily for visible blockage of airflow, e.g., large items or numerous containers blocking the lower slot opening in the rear of the hood. Airflow monitor devices should be observed before each use to check that the hood is functioning. If the hood does not have a monitor, secure a tissue paper strip at the opening to observe inward directional airflow; do not allow the paper to be drawn into the fume hood exhaust. Users should keep interior hood surfaces in a clean condition.

EHS checks fume hood airflow performance annually to confirm that:

  • airflow into the hood is not compromised by cross drafts;
  • airflow into the hood has a uniform inward pattern;
  • average velocity of air moving into the hood is within acceptable range.

Guidelines and results are noted on the hood sticker placed on the front of the hood. If results are not acceptable a notice will be placed on the hood sash and repair request sent to the Facilities Management Work Control Center.

The sash sticker indicates the maximum sash opening for hood use (the opening used for EHS testing). In the event a hood lacks a hood or sash sticker or the test date is older than one year, contact EHS.

Facilities Management periodically inspects and maintains the hood system components such as lights, fans, and motors. Equipment failures or problems should be reported to the Work Control Center at 335-5071.

9.4 Ventilation Failure Procedures

In the event of a ventilation failure or recurring low flow alarm on the monitor, occupants should contact the Work Control Center in Facilities Management (335-5071, 24 hours, 7 days). Occupants should place lids on open containers, lower the fume hood sash, and shut down equipment and secure reactions that may be generating hazardous emissions.

9.5 Refrigerators

Individuals and/or departments purchasing refrigerators for laboratory use are expected to follow university procedures that are in accordance with requirements of NFPA 45 (National Fire Protection Association), "Standard on Fire Protection for Laboratories Using Chemicals.” If flammable solvents need to be refrigerated a flammable-safe (lab-safe) refrigerator must be purchased. In nearly all situations this type of unit is necessary for lab use.  These units will be marked to indicate they meet the requirements for flammable/combustible material storage.

Flammable-safe refrigerators are designed to eliminate ignition of flammable vapors inside the storage compartment (by locating the compressor and other circuits that can arc/create a spark on the exterior of the unit). A domestic refrigerator must not be used to store flammables because they contain ignition sources that can set off explosive concentrations of flammable vapor. Vapors from a leaky stopper or a cracked container can build up to explosive concentrations and be ignited by the light switch or thermostat. Domestic refrigerators located in labs must be labeled "Do Not Store Flammables in This Refrigerator."

Cold rooms are also not designed for storage of flammable or volatile materials.  They may have exposed ignition sources and are not ventilated to actively remove chemical contaminants. Therefore, undesirable vapors may concentrate if these types of materials are stored in cold rooms.

9.6 Body Showers and Eyewash Stations

Iowa OSHA requires this equipment be provided in work areas where any person's eyes or body may be exposed to corrosive materials. The American National Standard Institute (ANSI) Standard Z358.1-2014 "Emergency Eyewash & Shower Equipment" provides the specific requirements. These requirements are rather extensive. Facilities Management addresses construction and renovation requirements. EHS may also be contacted for additional information.

Laboratory occupants should ensure that access routes to body showers and eyewash stations are free of obstructions. Laboratory occupants should activate water flow in eye wash stations periodically. If problems are noted with water flow contact the Work Control Center at Facilities Management (335-5071). Body showers are checked and maintained by Facilities Management.

9.7 Electrical Extension Cords

The National Electrical Code and the State Fire Marshal's Office prohibit use of extension cords as a substitute for permanent wiring. Multiple plug outlet adapters are also prohibited. If additional electrical outlets are needed in a work area, one of two possible solutions could be used to rectify the problem.

  1. The department can pay FM to install additional outlets.
  2. The department can complete a "Building Repairs Request" form and forward it to Facilities Planning. This option is contingent upon availability of funding.

The only exception granted is that the State Fire Marshal's Office will allow the University to use electrical power strips for personal computers and their components only in older and existing building operations. Remodeling and new construction must provide additional outlets for computers. These UL listed power strips come with a cord and an outlet box that has a 15-amp circuit breaker. These units should be purchased at General Stores.

9.8 Flammable Liquid Storage Cabinets

When purchasing flammable liquid storage cabinets the following specifications must be met:

  1. Cabinets must comply with NFPA and IOSH Standards.
  2. Cabinets must have self-closing door(s), with red lettering stating "Flammable Keep Fire Away".
  3. Two doors are required on all cabinets except 10 and 20-gallon sizes where one door is required. Where two doors are required, they may be either bifolding or hinged on each side.
  4. Cabinets must be of approved metal construction and meet minimum construction requirements:
    1. Bottom, top, sides and door(s) of cabinet shall be at least No.18-gauge sheet metal and double walled 1 1/2-inch air space.
    2. Joints must be riveted, welded or made liquid tight by some equally effective means.
  5. Door must be provided with three-point latch arrangement and the doorsill shall be raised at least two inches above bottom of the cabinet to retain spilled liquid within the cabinet.

9.9 Guarding

All mechanical equipment should be adequately furnished with guards that prevent access to electrical connections or moving parts; e.g., belts and pulleys of a vacuum pump. Each laboratory worker should inspect equipment before using it to ensure that the guards are in place and functions. Careful design of guards is vital. An ineffective guard can be worse than none at all, because it can give a false sense of security. Emergency shutoff devices may be needed in addition to electrical and mechanical guarding.

Appendix A

CATEGORY A INFECTIOUS SUBSTANCES*

UN 2814: Infectious substance, affecting humans

Bacillus anthracis (cultures only)

Brucella abortus (cultures only)

Brucella melitensis (cultures only)

Brucella suis (cultures only)

Burkholderia mallei-Pseudomonas mallei - Glanders (cultures only)

Burkholderia pseudomallei-Pseudomonas pseudomallei (cultures only)

Chlamydia psittaci-avain strains (cultures only)

Clostridium botulinum (cultures only)

Coccidioides immitis (cultures only)

Coxiella burnetii (cultures only)

Crimean-Congo hemorrhagic fever virus

Dengue virus (cultures only)

Eastern equine encephalitis virus (cultures only)

Escherichia coli, verotoxigenic (cultures only)

Ebola virus

Flexal virus

Francisella tularensis (cultures only)

Guanarito virus

Hantaan virus

Hantaviruses causing haemorrhagic fever with renal syndrome

Hendra virus

Hepatitis B virus (cultures only)

Herpes B virus (cultures only)

Human immunodeficiency virus (cultures only)

Highly pathogenic avian influenza virus (cultures only)

Japanese Encephalitis virus (cultures only)

Junin virus

Kyasanur Forest disease virus

Lassa virus

Machupo virus

Marburg virus

Monkeypox virus

Mycobacterium tuberculosis (cultures only)

Nipah virus

Omsk hemorrhagic fever virus

Poliovirus (cultures only)

Rabies virus

Rickettsia prowazekii (cultures only)

Rickettsia rickettsii (cultures only) 

Rift Valley fever virus

Russian spring-summer encephalitis virus (cultures only)

Sabia virus

Shigella dysenteriae type 1 (cultures only)

Tick-borne encephalitis virus (cultures only)

Variola virus

Venequelan equine encephalitis virus (cultures only)

West Nile virus (cultures only)

Yellow fever virus (cultures only)

Yersinia pestis (cultures only)

UN 2900: Infectious substance, affecting animals

African swine fever virus (cultures only)

Avian paramyxovirus Type 1- Newcastle disease virus (cultures only)

Classical swine fever virus (cultures only)

Foot and mouth disease virus (cultures only)

Lumpy skin disease virus (cultures only)

Mycoplasma mycoides – Contagious bovine pleuropneumonia (cultures only)

Peste des petits ruminants virus (cultures only)

Rinderpest virus (cultures only)

Sheep-pox virus (cultures only)

Goatpox virus (cultures only)

Swine vesicular disease virus (cultures only)

Vesicular stomatitis virus (cultures only)

*This list is not exhaustive.

Appendix B

RESOURCES

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, February 2007, U.S. Department of Health and Human Services Center for Disease Control and Prevention and National Institutes of Health

Bloodborne Pathogens, 29 CFR 1910.1030

Centers for Disease Control and Prevention, Department of Health and Human Services

Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), National Institutes of Health NIH Guidelines

Laboratory Biosafety Manual, 3rd Edition, 2004, World Health Organization

National Institutes of Health

Occupational Safety and Health Administration (OSHA), United States Department of Labor

Select Agent Program, Department of Health and Human Services, Centers for Disease Control and Prevention

Select Agent Program, United States Department of Agriculture, Animal and Plant Health Inspection Service

Appendix B Educational Information on Lead

  1. What is Lead?
  2. Materials Suspected of Containing Lead 
  3. How does Exposure Occur?
  4. Health Effects
  5. Exposure Limits
  6. Guidelines for Minimizing Exposures
  7. Tasks that Do Not Produce Excessive Exposures 
  8. Tasks that May Produce Excessive Exposures
  9. Tasks that Do Produce Excessive Exposures
  10. Medical Considerations
  11. Waste Disposal Guidelines
  12. Information Web Sites

Introduction

Poisoning as a result of overexposure to lead is the oldest recorded occupational disease.  The significant health risk posed by too much lead entering the human body has been known and documented for thousands of years.  Most lead exposure problems in adults occur from occupational exposures in the construction or manufacturing industries.  An especially high health risk from excessive lead exposure exists for pregnant women and young children.  Most recently, concerns about lead exposure have focused on the potential danger to young children from lead in and around homes, day care centers, and pre-schools.  

What is Lead?                                                                                                                                         

Lead is a soft, dense, inorganic heavy metal that oxidizes in air and is commonly found in the environment in a number of ores.  Lead is often combined with other metals to form alloys and other substances to create a variety of compounds. Lead-based paint is paint that contains at least 1 mg/cm2 or 5000ug/g (0.5%) lead by weight.

Items and Materials Containing Lead                                                                                                                   

Items and materials that are commonly known to contain lead include:

  • Any painted surface on the interior or exterior of a building or structure constructed prior to 1978.
  • Debris, paint chips, or dusts inside or near the exterior of pre-1978 painted buildings and structures.
  • Soil from or next to the exterior of pre-1978 painted buildings and structures.
  • Lead pipes, lead based solder or plumbing fixtures in older buildings, and lead lined water coolers.
  • Soil near heavily used streets and roads.
  • Window glazing.
  • Drinking water delivered through piping in older buildings.
  • Old toys, imported toys. 
  • Lead-glazed and/or lead-painted pottery.
  • Leaded crystal.
  • Sinkers, ammunition, stain glass work.
  • Storage batteries.
  • Roof flashing.
  • Inks.
  • In resins as a stabilizer.
  • As radioactive protective shielding.
  • Telephone and television cable sheathing.

How does Exposure Occur?                                                                                                                              

In​halation

Inhalation is the most common source of occupational lead exposure.  Lead can become airborne when it is burned or melted to a temperature high enough to release a fume into the air.  It is also released into the air when dust from lead painted surfaces is disturbed, or created by abrasion of the paint.  Lead dust can also be released from contaminated clothing worn by a worker.  Airborne lead dusts or fumes can be inhaled into the lungs and upper respiratory tract, where it is readily absorbed and distributed throughout the body.  

Ingestion

Ingestion is the most common source of lead exposure in children.  Small children may eat lead paint chips or play in contaminated soil.  While adults do not typically eat paint chips, they may handle cigarettes, food, chewing tobacco, or apply make-up that has been contaminated by lead, or use these products with lead-contaminated hands.  Lead can also be ingested from water that has been contaminated by lead in water pipes or containers.

Skin ​absorption

Skin absorption is not normally a lead hazard because inorganic lead is not absorbed through the skin.  Skin absorption was a hazard when skin absorbable organic leads (tetraethyl and tetramethyl lead) were used as gasoline additives; their use has been banned by the EPA since 1/1/1996.

Health Effects                                                                                                                                        

The effects of lead normally accumulate over time from a series of exposures.  Most lead is absorbed through the lungs or digestive tract and enters the blood stream. While some lead in the blood stream is excreted, the rest remains in the blood and is stored in other tissues.  Extended exposure to lead, especially in high doses, increases the amount stored in the body.  When too much lead has entered the body, visible effects and symptoms begin to appear.  Lead poisoning is normally treatable, though some of the effects can be permanent when exposure levels have been excessive for long periods of time.  Children under the age of six and fetuses exposed through lead in the mother’s blood are most susceptible to lead poisoning.  Lead poisoning has been linked to anemia, central nervous system disorders, kidney and immune system damage, reproductive disorders, and learning disabilities.

In both adults and children, the signs and symptoms of lead poisoning are often confused with those of other common illnesses and misdiagnoses can easily occur.  Because symptoms do not usually develop until the condition has become very serious, someone with lead poisoning may appear to be healthy. 

Common signs and symptoms of lead poisoning include headaches, joint pain, fatigue, muscle ache, clumsiness, nervousness, a poor appetite, metallic taste in mouth, irritability, sleeplessness, abdominal pain, and constipation.  Adults may also have impotency, decreased fertility or miscarriages.  Children may also have behavioral problems and learning disabilities. Symptoms of severe poisoning may include nausea/vomiting, loss of balance, stupor, seizures, coma, and blue tints to gums and skin under fingernails.

Exposure Limit Information                                                                                                                            

Lead is a recognized health hazard. Consequently, exposure limits have been developed to protect people from excessive exposure.  Lead exposure limits that are either regulated or recommended by government agencies include: 

  • OSHA (Occupational Safety and Health Administration) – sets regulatory limits for workplace daily airborne exposure to lead and the levels permissible in the bloodstream of workers with occupational contact with lead. The current lead exposure limits for workplace air are 50 mg/cm3, with an action level of 30 mg/m3. The current blood lead limits are 40ug/dl. The regulations are enforced by the Iowa Occupational Safety and Health (IOSH) Enforcement in the Labor Services Division of Iowa Workforce Development.
  • EPA (Environmental Protection Agency) – sets regulatory limits for the amount of lead contained in paint, dust, and soil in and on the grounds of pre-1978 housing and child occupied facilities.  The current exposure limits are:  40 ug/ft2 for floor dust; 250 ug/ft2 for interior windowsill dust; 400 ug/ft2 for bare soil in play areas; and 1,200 ug/ft2 for bare soil in non-play areas.  These regulations are enforced by the Iowa Department of Public Health.
  • EPA – has a regulatory limit for lead levels in ambient air to remain at or below 1.5 ug/m3 as averaged over a 3 month sample period.  This regulation is enforced by the Iowa Department of Natural Resources.
  • EPA – recommends a maximum concentration of lead in drinking water of 15 ug/L of water. This regulation is enforced by the Iowa Department of Natural Resources.
  • CDC (The Centers for Disease Control and Prevention) - recommend all children be screened for blood lead levels once per year, especially between the ages of 6 months and 6 years.  Children with blood levels at or in excess of 10 ug/l should be included in a childhood lead prevention program.  These recommendations are supported through the Iowa Department of Public Health.

Guidelines for Minimizing Lead Exposure                                                                                                               

  • Employers need to be aware of materials in their workspaces that contain, or are suspected of containing, lead  
  • Employers must assume that all materials suspected of containing lead do contain lead unless proper testing proves otherwise.  Determining the concentration of lead in materials is done by analysis of samples taken by trained professionals using appropriate and approved sampling methods. Lead swab testing (sodium rhodonzonate) is not an approved method to test for either the presence or concentration of lead in materials.  
  • Employees who perform activities that could potentially disturb materials containing or suspected of containing lead, must receive specialized training.  Employers are responsible for training their employees on the health effects of lead exposure, and the types and locations of lead-containing materials in their workplace.  
  • Employees must be trained to not disturb materials containing or suspected of containing lead, or be made aware of tasks that do and do not create significant lead exposure.  Employers must also provide their employees with equipment necessary to perform the tasks safely and comply with federal and state regulations pertaining to lead.
  • Employers not familiar with regulatory requirements should obtain guidance when planning renovation, remodeling, or demolition work that could involve disturbing materials suspected of containing lead.  Requirements include specific procedures, training, and licenses. 

Tasks that Do Not Produce Excessive Exposures                                                                                                         

These tasks are normally considered as not producing excessive exposure to lead.  This is not a complete list of tasks that do not produce excessive exposure to lead.  It does not exclude the possibility that a task on the list could be performed in a way that could produce excessive exposure to lead.  

Tasks generally not requiring precautions and/or protective measures for lead exposure include:

  • Removal of nails, screws, picture hangers, or other fasteners, etc., from a painted wall surface.
  • Removal of cover plates, switch covers, etc., from a painted surface.
  • Removal of hinge pins or painted door hinges.
  • Removal of lock hardware, closers, or other hardware accessories from a painted door.
  • Wet sanding drywall compound or spackle using a sponge.
  • Separating and removing anything attached to a painted baseboard.
  • Planing painted wood with manual tools.
  • Drilling or preparing a painted door from installation of new door hardware (lock set, closers, kicker plate etc.).
  • Re-nailing or refastening loose building trims, moldings or panels.
  • Re-glazing of window glass.
  • Removal of painted phone line or electrical wire.
  • Freeing an inoperable window.
  • Housekeeping, including emptying trash, vacuuming carpets, dust mopping hallways, cleaning water fountains, buffing floors, and disinfecting bathrooms.
  • Maintenance, including replacing air filters, replacing toilet flush valve, replacing light bulbs, checking and repairing shower valves, unclogging a shower drain using a “snake,” mechanical repair of an air-conditioning unit, and repairing a shower leak.
  • Carpentry activities, including removing wooden windows to measure to make screens, sweeping out the carpentry shop, planing the edge of a door and re-installing the hinges, re-hanging the door, removing outside entrance door, removing the kick plate, and removing the screws.
  • Carpentry activities, including removing door hinges and lockset and replacing.
  • Carpentry activities, including sanding floor with “stand-behind” power disc sander, scraping floor near corner, cleanup of debris, and placing debris in container.
  • Carpentry activities, including wet hand scraping and wet sanding a column.
  • Carpentry activities, including removing painted baseboards, cutting and pulling up wall-to-wall carpeting, scraping walls near baseboard, scraping carpet adhesive residue from floor, and sweeping floor.
  • Carpentry activities, including removing window casing and painted molding, removing the window sash, heating the glazing, scraping and removing the softened glazing, re-installing the sash, re-hanging the window, and installing the wooden molding.
  • Removing old plaster and re-plastering, manually sanding new plaster.
  • Maintenance activities, including wet scraping of window and door.
  • Plumbing activities, including manually removing old lead and oakum from around shower drains, heating lead in an open ladle using a propane torch, pouring the molten lead from the ladle into the cavity surrounding the drain, rapidly cooling the unused hot lead using cooling water from a sink faucet.
  • Chipping and sanding plaster.
  • Painter activities, including spreading plastic material around the hot-water radiator and wet scraping old paint from hot-water radiator, folding up the plastic on the floor, broom sweeping the floor.

Tasks that May Produce Excessive Exposure                                                                                                             

These tasks are normally considered as capable of producing excessive exposure to lead.  This is not a complete list of all tasks capable of producing excessive exposure to lead.  It is possible that a task on the list could be performed in a way that would not produce excessive exposure to lead. 

Tasks that may require precautions and/or protective measures for lead exposure include:

  • Cleaning damaged or deteriorated lead based paint surfaces.
  • Removing lead based paint chips and debris.
  • Removing small areas of lead based paint.
  • Wet sanding of lead based paint.
  • Penetrating lead based paint.
  • Removing components from lead based paint surfaces.
  • Attaching to a lead based paint surface.
  • Applying coatings to lead based paint surfaces.
  • Installing materials over lead based paint surfaces.
  • Enclosing a lead based paint surface.
  • Exposing Lead Based Paint contaminated cavities.
  • Lead based paint door and window maintenance.
  • Changing filters and waste bags in lead based paint contaminated HEPA vacuums.
  • Cleaning lead dust contaminated carpet.
  • Landscaping in soil containing elevated levels of lead based paint.

Tasks that Do Produce Excessive Exposure                                                                                                              

These tasks normally produce excessive exposure to lead.  This is not a complete list of all tasks producing excessive exposure to lead.

Tasks that require precautions and/or protective measures for lead exposure include:

  • Welding, cutting, or torch burning and related activities on lead containing materials.
  • Abrasive blasting and related activities on lead containing materials.
  • Dry sanding, scraping, or demolition and related activities on lead containing materials.
  • Heat gun or burning removal of lead based paint from surfaces.
  • Spray painting with lead based paint.

Medical Considerations                                                                                                                                

Surveillance

In accordance with OSHA standards, any employee who performs construction work and is occupationally exposed on any day to an average airborne lead level of 30 ug/m3 or higher, shall have initial medical surveillance.  Employees occupationally exposed to an average daily airborne lead level at or above 30 ug/m3 for more than 30 days in any consecutive 12 months, will be offered scheduled lead medical surveillance per OSHA regulations.  Also, initial medical surveillance will be done on any employee if the attending physician has reason to suspect may have been exposed to high levels of lead. The University Employee Health Clinic provides medical surveillance.

Medical Consultation

A medical examination shall be provided annually for any employee who has had a blood-lead level of 40 ug/dl or greater, or has been medically removed in the past 12 months.  A medical exam shall also be provided to any employee in a lead medical surveillance program, for any of the following circumstances:

Employee experiences symptoms consistent with lead intoxication.

Employee needs consultation concerning the potential effects of past lead exposure or on the ability to procreate or carry a healthy child.

Employee has difficulty breathing during fit-testing or use of a respirator.

Chelation

Prophylactic chelation may only be performed by a licensed physician and conducted in a clinical setting with thorough and appropriate medical monitoring.  The employee must be notified in writing by the UIHC Workers Health Clinic prior to performing chelation.  (External physicians planning on performing chelation must first notify the employee and the Workers Health Clinic).

Medical Removal Protection

Any employee who has a blood lead level of 50 ug/dl or more shall be excluded from work that has potential for lead exposure until the employee has had two (2) consecutive blood samples at or below 40 ug/dl.

Any employee may also be excluded from lead-related work when results of a medical consultation determine that the employee’s health may be at risk of impairment from exposure to lead.  The medically removed employee may return to former duties upon receipt of a written opinion from the consulting physician that the conditions placing the employee at increased risk are no longer present or of material concern.

Waste Disposal Guidelines                                                                                                                             

EPA standards determine whether the waste must be managed and disposed of as hazardous or nonhazardous waste. Waste containing lead must be managed and disposed of as hazardous waste unless the laboratory EPA TCLP test characterized the waste as containing less than 5 mg/l of lead.

 

B. Principal Investigator Working with Select Agents or (Non-Exempt) Toxins

 A Principal Investigator Working with Select Agents or (Non-Exempt) Toxins  is responsible for:

  • Contacting Haley Sinn, RO, and arranging to obtain CDC/FBI approval prior to any work with Select Agents or Toxins.
  • Receiving prior approval from the RO and, the Federal Government for all transfers of select agents or toxins into or out of the facility.
  • Adhering to proper procedures outlined in all applicable safety and security manuals. 
  • Maintaining a list of select agent approved staff.
  • Apprising staff of the hazards associated with the select agent or toxin and ensuring staff are properly trained prior to working with the agent, including:
  1. Laboratory specific training.
  2. EHS general training (e.g., Bloodborne Pathogens, Basic Biosafety, Lab Chemical), if appropriate.
  3. Animal Care and Use training, if appropriate.
  • Preparing written Standard Operating Procedures (SOPs) for select agent or toxin research procedures and ensuring no research is conducted that is not outlined in the SOP.
  • Apprising the RO and any applicable committees of all changes in the research proposal, including:
  1. Use of recombinant DNA or synthetic nucleic acids or recombinant organisms.
  2. Changes in the select agent or toxin.
  3. Changes in staff.
  4. Use of animals.
  • Maintaining a current inventory.

 

I. Summary

The Select Agent and Toxin Use program outlines the registration procedures and responsibilities for individuals who work with select agents and toxins. The University of Iowa and all individuals involved with select agent and toxins are required to comply with the Select Agent Program established by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS). Compliance is required under Federal Law; non-compliance can result in substantial penalties for both an individual and the University. All individuals must register with the University and possibly the Federal government prior to possessing any select agent or toxin.

I. Summary

All non-exempt research​1 involving recombinant or synthetic nucleic acid molecules must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The NIH Guidelines, which are published in the Federal Register, define allowable practices for the construction and handling of recombinant or synthetic nucleic acid molecules and their introduction into viruses and cells. Under the NIH Guidelines the Institutional Biosafety Committee (IBC) is charged with assessing the risk of and determining the biosafety containment level required for all proposed recombinant or synthetic nucleic acid research.

Investigators intending to perform any non-exempt research involving recombinant or synthetic nucleic acids must describe such proposed research in a recombinant or synthetic nucleic acid Registration Document and submit it to the IBC for review. Research involving non-exempt recombinant or synthetic nucleic acids cannot be initiated without prior, specific IBC approval. Such approval is required regardless of the source of funding of the proposed research.

​Note:

1Exempt recombinant or synthetic nucleic acid research is defined under Section III-F in the NIH Guidelines.

II. Scope

The University of Iowa Select Agent and Toxin Use program is applicable to any employee of the University having access to a select agent or toxin. Access includes the ability to carry, use or manipulate an agent or toxin or the ability to gain entry into an area where select agents or toxins are used or stored.

II. Scope

The NIH Guidelines and the procedures summarized in this document apply to all non-exempt recombinant and synthetic nucleic acids research performed at the University of Iowa.

III. Applicable Regulations

Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001:

This law criminalizes the possession of select agents for which there is no legitimate purpose, banned the possession of select agents by a set of “restricted persons”, and required the Secretary of Health and Human Services (HSS) to establish additional standards and procedures governing the possession, use, and transfer of select agents. The biological agents and toxins subject to these rules have the potential to pose a severe threat to public health and safety, to animal health or to animal products. The Patriot Act is a Federal anti-Terrorism Law that makes it criminal to “knowingly possess any biological agent, toxin, or delivery system of a type or in a quantity that … is not reasonably justified by a … bona fide research or other peaceful purpose.” Intent to use the material as a weapon is not required.

Public Health Security and Bioterrorism Preparedness and Response Act of 2002:

This law established legal requirements regarding the possession, use and transfer of select agents and toxins. The Department of Health and Human Services (DHHS)/Center for Disease Control and Prevention (CDC [2]) and United States Department of Agriculture (USDA [3]) have set forth rules regarding the possession, use and transfer of select agents and toxins. These rules, defined as the Select Agent Program , are outlined in 42 CFR 73 [4] (Code of Federal Regulations) for the CDC and 7 CFR 331 and 9 CFR 121 [4] for USDA/APHIS. The initial program took effect in 2002; the interim Final Rule has since been replaced with the Final Rule on March 18, 2005; the regulations undergo biennial review.

 

Introduction

The University of Iowa Laser Safety Program is designed to provide guidance for the safe use of lasers in research and to help provide for the safety of all personnel and visitors that may be exposed to the radiation emitted by lasers.

The laser safety policy is based on standards promulgated by ANSI Z136.1, and applies to all lasers and laser systems, whether purchased, borrowed, fabricated, or brought in for use by others.

Many lasers are capable of causing eye injury to anyone who looks directly into the beam.  Reflections alone from high-power laser beams can produce permanent eye damage.  High-power laser beams can also burn exposed skin.  Laser operators must be aware of other potential dangers such as fire, electrical, biological and chemical hazards.

This manual will provide basic information on laser operation and safety practices, as well as University policy regarding the safe use of lasers and laser systems.  Beam hazards are discussed in the body of the text and non-beam or associated hazards are discussed in Appendix 1.

Registration

All Class 3B and Class 4 lasers at the University of Iowa must be registered with the Environmental Health & Safety (EHS).  Please contact the Environmental Health & Safety at 335-8501 prior to receiving a laser so that the unit can be registered and the work area, procedures, and safety-related equipment can be evaluated prior to use of the laser.  

Responsible Parties

Laser Safety Officer

The Laser Safety Officer will be responsible for:

  • Maintaining inventory of all Class 3B and Class 4 lasers and verifying classification if necessary.
  • Reviewing standard operating procedures, alignment procedures and other control measures, before initial use. 
  • Periodically inspect Class 3B and Class 4 lasers to assess compliance with safety requirements. 
  • Providing assistance in evaluating and controlling hazards.
  • Maintaining records of Class 3B and Class 4 laser inspections. 
  • Participating in accident investigations involving lasers.
  • Suspending, restricting or terminating the operation of a laser or laser system without adequate hazard controls.

Laser Operator

The laser operator is responsible for:

  • Completing all applicable requirements including training and medical surveillance, as applicable, before operating a laser.
  • Operating lasers safely and in a manner consistent with safe laser practices, requirements and standard operating procedures.  This includes the use of personal protective equipment as applicable.
  • Maintaining a safe environment/area during the operation of a laser.

Principal Investigator

The Principal Investigator is responsible for:

  • Notifying EHS of the intent to procure a laser, and providing required information for registration and safety reviews for lasers.
  • Providing laser specific training for all operators.
  • Ensuring each assigned laser is operated safely and in accordance with applicable requirements.
  • Providing medical surveillance for laser operators and ancillary personnel as described in Medical Surveillance and Exposure Incidents, as applicable. 
  • Ensuring that each laser is stored securely and safely when not in use so that it is not usable by unauthorized personnel or under unauthorized conditions.
  • Maintaining written SOPs for Class 3B (if required) and all Class 4 lasers and ensuring laser use is commensurate with the requirements of the SOP.
  • Informing the EHS prior to receiving a laser, transferring a laser to another user, sending a laser to another site off-campus, or disposal of a laser or laser system.
  • Reporting any known or suspected accidents to the Laser Safety Officer.
  • Ensuring that a hazard assessment for personal protective equipment (PPE) use and specific PPE training is provided for all laser users for whom PPE will be required.

IV. Definitions

APHIS: Animal and Plant Health Inspection Service

BSO: Biological Safety Officer

DSP: Division of Sponsored Programs

DURC: Dual Use Research of Concern: life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential negative consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security in the foreseeable future​.

EHS: Environmental Health & Safety

IBC: Institutional Biosafety Committee

IO: Institutional Official

NIH: National Institutes of Health

NIH/OBA: Office of Biotechnology Activities, Office of the Director, NIH

NSABB: National Science Advisory Board for Biosecurity

PI: Principal Investigator

RAC: Recombinant DNA Advisory Committee, Office of the Director, NIH

rDNA (recombinant deoxyribonucleic acid): recombinant DNA molecules are defined as: (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.

rsNAM (recombinant or synthetic nucleic acid molecules): defined as: (i) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids; or (iii) molecules that result from the replication of those described in (i) or (ii) above.

rDNARD: rDNA Registration Document

Synthetic DNA: Synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypeptide are considered as equivalent to their natural DNA counterpart.

USDA: United States Department of Agriculture

Asst. VPR: Assistant Vice President for Research Compliance

Notes:

 1United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

IX. IBC Annual Review / Annual Reporting of Approved Protocols

  1. Approved DNARDs will be reviewed annually for two years and expire three years after initial approval.
  • Eleven months after initial approval, and again one year and 11 months hence, a notification will be sent to the PI by the Biosafety Office with a request that he/she review the previously-approved project.
  • The PI must reply by return email, marking one of the following responses:
    • the project is inactive;
    • the project no longer involves rsNAM;
    • the project is active, no changes; or
    • the project is active and changes are anticipated, e.g., changes in title, funding source, personnel involved in the research, inserts, hosts, vectors or animals used (the changes must be specified)
  • When a PI indicates that changes as listed above are planned, the changes may be approved administratively (title, funding, or staff changes), approved by the IBC Chair (host/vector/insert changes that do not change the BSL/ABSL of the protocol) or approved following full committee review (significant changes to the scope and/or BSL/ABSL of the protocol).
  • Two years and 11 months after initial approval, a notification will be sent to the PI stating that the project was approved three years ago and can only be renewed by submitting a newly-completed rDNARD. The PI must reply and indicate that the project is not active or, if the research is to continue, a new rDNARD will be submitted.
  • When submission of a new rDNARD is not required, the date of the PI’s review and changes indicated by him/her will be entered into the electronic rDNA database. If the project is inactive, the related information in the database will be archived, thereby precluding additional reminder cycles.
  1. Investigators who have protocols involving human subjects must comply with annual data reporting requirements. Annual data report forms will be forwarded by NIH OBA to investigators. Information submitted in these annual reports will be evaluated by NIH OBA and the RAC, and possibly considered at a future RAC meeting. Send a copy of the annual data report form to Haley Sinn, Biological Safety, Environmental Health & Safety (100 EHS).

IX. Medical Surveillance and Exposure Incidents

If an exposure incident occurs, the affected individual(s) shall inform their supervisor and be referred immediately to the Worker's Health Clinic, located in Clinic A of Boyd Towers. The employee will be evaluated and/or referred for ophthalmologic assessment as appropriate. If the incident occurs outside of regular clinic hours, the employee(s) should be seen in the UIHC Emergency Treatment Center. In addition, the employee must complete a “Worker’s Compensation First Report of Injury or Illness” form. See UIHC Laser Safety Policy for further detail.

EHS will conduct an investigation and an incident report will be written.

VII. Procedures for Initial Registration of Experiments Involving rDNA

  1. New projects involving rsNAM:
    When a PI completes a Division of Sponsored Program (DSP) Proposal Routing Form and indicates that the proposed project involves rsNAM, a follow-up notification to the PI will be generated by DSP that serves as a reminder that IBC approval may be required. Links to the electronic rDNARD and the NIH Guidelines are included in the memo. Environmental Health & Safety (EHS)’s Biosafety Office receives a copy of the memo to the PI and will ensure there is follow up.
  2. The PI must complete the electronic rDNARD and submit it to the Biosafety Office if IBC approval is required.
  3. The Biosafety Office will send the completed rDNARD to the IBC members for review (See Section VIII).
  4. An on-site audit will be performed annually in the laboratory of each PI whose proposed rsNAM research must be conducted at Biosafety Level 2 or higher. If the PI has not been audited previously, an initial audit will be conducted at the time the rDNARD is approved.

VIII. Dates

June 2006

November 2008

February 2010

February 2011

April 2013

VIII. IBC Process for Review of rDNA Registration Documents

  1. Protocols not involving human research participants
  2. Protocols involving human research participants
  3. For experiments that might be considered “dual use research” (DUR)
  4. Minutes of IBC meetings
  5. Copies of approval letters
  6. All documents relating to the University's regulation of rsNAM.

Protocols not involving human research participants:

  • Upon receipt of a completed rDNARD, the Biosafety Office will review it for completeness and if necessary request additional information from the PI. If the requested information is provided by the PI in adequate time, the rDNARD will be re-reviewed, and if appropriate, included in the agenda for the next IBC meeting.
  • Completed rDNARDs will be moved into the “Committee Review” section of the online registration program. One week prior to the IBC meeting, an automatic e-mail will be generated that includes a hyperlink to each pending completed rDNARD that will be discussed during the next IBC meeting.
  • An IBC meeting will be held every two weeks to review all pending completed rDNARDs.
  • Each rDNARD requires IBC action by a majority vote of the members attending a meeting in one of the following ways: approved, disapproved or tabled. If an IBC member has a conflict of interest as defined by University policy, he/she must make the conflict known and recuse him/herself from the consideration of that protocol.
  • Members unable to attend a scheduled meeting may submit comments or concerns on pending rDNARDs scheduled for consideration to the Biosafety Office prior to the meeting. During the scheduled meeting, comments or concerns so submitted will be read to the members in attendance.
  • For each rDNARD approved by the IBC, the Biosafety Office will change the status of the rDNARD to “approved” and an automated e-mail will be sent to the PI (and Co-PIs and authorized users). The approved rDNARD, accessible through the online registration program, will bear the approval date and the expiration date.
  • If a majority of IBC members in attendance at a meeting determines that additional information is needed for an rDNARD under consideration and for this reason votes to table the Document, the following procedure will be used:
    • The Biosafety Office or the IBC chair will send to the PI a request for the additional information deemed necessary by the IBC no later than two business days after the IBC meeting. The request will indicate the date of the next protocol submittal to the IBC and the PI will be advised to provide a written response containing the additional information at least two days prior to that date. This written response may take the form of a comment or, if appropriate, may take the form of a revised rDNARD that includes the requested additional information.
    • Upon receipt of a response from the PI, it will be forwarded to the IBC members at least one week prior to the next scheduled meeting and the rDNARD in question will be included in the table that lists the rDNARDs that will be considered at that meeting.
    • If the IBC deems the PI’s response to its request for additional information as inadequate, the committee will request the PI attend the next IBC meeting.
    • If the PI does not respond to the request for additional information by the requested date, the Biosafety Office or the IBC chair will send a second request to the PI. This request will indicate the date of the next scheduled IBC meeting at which the rDNARD would be reconsidered and the PI will be advised to provide to the IBC chair a written response at least one week prior to that date.
    • Based upon the PI’s written or verbal responses to the request for additional information, the IBC will approve, disapprove, or table the rDNARD by majority vote of the members in attendance at the meeting. If appropriate, the Biosafety Office or the IBC chair will ask the PI in a written comment associated with the rDNARD to revise the rDNARD by inserting the additional information and resubmit it to the Biosafety Office.
    • If the PI does not respond to the second request for additional information, the rDNARD will be withdrawn from consideration and will be returned to the PI.
    • At any point in the above procedure, an IBC member or the PI may request that the PI appear before the IBC, and such request will be honored.

Protocols involving human research participants:

  1. PIs must review Appendix M of the NIH Guidelines and submit the required documentation to OBA for review and discussion by RAC.
  2. After receiving correspondence regarding RAC review, the investigator should submit that correspondence, any response by the PI to recommendations made by RAC (if applicable), along with a completed online rDNA Registration Document for IBC review. NOTE: IRB review will also occur after the PI submits correspondence and recommendations from RAC and all required forms through the HAWK IRB system.
  • IBC review will include a review of:
    • The informed consent document.
    • Safety of the vectors used.
    • Risks to the patient, given the vector used.
  1. PIs will be notified through e-mail when their DNARD is approved by the IBC. PIs will have access to the electronically signed document for their files and to use in providing copies to granting agencies/regulatory agencies.
  2. Only after RAC review has been completed, the IRB and IBC approvals received, and all applicable regulatory authorizations have been obtained can research participants be enrolled in the human gene transfer experiments.
  3. No later than 20 working days after enrollment of the first research participant, PIs shall submit the following documentation to NIH OBA:
    • A copy of the informed consent document approved by the IRB;
    • A copy of the protocol approved by the IBC and IRB;
    • A copy of the final IBC approval from the clinical trial site;
    • A copy of the final IRB approval;
    • A brief written report that includes how the investigator responded to each of the RAC’s recommendations on the protocol (if applicable) and any modifications to the protocol as required by the FDA;
    • Applicable NIH grant number(s);
    • The FDA Investigational New Drug Application (IND) number; and
    • The date of the initiation of the trial.

For experiments that might be considered “Dual Use Research of Concern” (DURC), the following procedure will be used:

  1. IBC members will evaluate the proposed experiments using the US Government Policy's1 seven classes of dual use experiments involving rsNAM to determine if the experiments proposed meet DURC criteria. Any IBC member may request that a vote be taken on whether the experiments proposed in an rDNARD under consideration meet these criteria.
  2. If a majority of the members present at a meeting vote that the proposed experiments meet DURC criteria, the following procedure will be used; if a majority of the members present do not vote in this manner, the usual procedure for processing rDNARDs will be followed.
  3. A completed rDNARD first must be considered and approved by a majority vote of the IBC before the following process takes place.
    • As soon as possible (no later than one week) after IBC approval of the completed rDNARD, the IBC Chair will send to the Asst. VPR for further consideration, a copy of the rDNARD and a letter outlining the IBC members’ reasons for deciding that the proposed experiments meet DURC criteria.

Minutes of IBC meetings

IBC meeting minutes will be transcribed by Biosafety Office staff and then will be reviewed, revised and approved by the IBC Chair, distributed to all members, and kept on file in the Biosafety Office.

Copies of approved rDNARDs

Copies of approved rDNARDs in which experiments involving human subjects are proposed will be sent to the IRB Office with notification that the protocol was approved.

All documents relating to the University’s regulation of rsNAM,

All documents relating to the University's regulation of rsNAM including but not limited to submitted rDNARDs, IBC meetings, and all correspondence, will be maintained online within the electronic database, and where appropriate, kept on file in the Biosafety Office.

​Note:
1United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern

 

VIII. Laser Disposal Guidelines

Disposal of laser systems or components should adhere to the following guidelines. The steps are listed in order of preference:

  1. Trade the obsolete laser to the new laser supplier/manufacturer.
  2. Obsolete laser disposal should minimize potential hazards to humans and the environment while eliminating UIHC liability.
  3. Reuse the obsolete laser for other purposes within the UIHC/UI (i.e. UI Engineering, UI Med Labs.)
  4. Render the obsolete laser unserviceable.
  • Use the obsolete laser components for other lasers
  • Use an outside firm to dismantle and dispose of the obsolete laser (i.e. ATEC in Des Moines charges by the pound)
  1. Dispose the obsolete laser via medical equipment broker
  • Use legal (hold harmless) form
  • Transfer to “missions” or 3rd world country
  1. Reuse/transfer/sell the obsolete laser for non-medical use (i.e. education, research, animals, etc...)
  • Use legal (hold harmless) form
  1. Review laser disposal with the UIHC-LSO and/or Bio-Engineering. Note: Functional lasers are not to be sent to UI Surplus.

Additional things to consider when disposing of a laser include:

  • Disposition of UI property tag
  • The laser contains hazardous materials
  • Disposition of hazardous materials
  • Stored electrical energy discharge
  • The laser to remain in the UI/UIHC safety jurisdiction
  • The laser contains biohazards
  • The laser has been decontaminated
  • The laser purchaser will sign a legal (hold harmless) form
  • The obsolete laser does not contain fire/explosive hazards
  • Provide manuals to laser purchaser (if available)

X. Process for Requesting Amendments

Minor changes to rDNARDs can be approved as amendments by the IBC Chair without full committee review; major changes require review and approval by the full IBC. Requests for amendments will be processed by the BSO prior to their being sent to the IBC Chair or full committee. To initiate the process of amending an approved rDNARD the PI or authorized user must access their protocol online and amend the protocol with the proposed changes. To facilitate review and record keeping, it is requested that if appropriate, the PI insert the changes in highlighted form in the table that is attached to the approved rDNARD

  • Requests for changes will be reviewed on a case-by-case basis to ensure that the changes proposed qualify as a minor amendment. Examples of changes that could be considered a minor amendment include the addition of a co-PI, addition/change to a vector requiring the same BSL, use of a less or equally hazardous cell line, or adding a non-pathogenic host such as an E. coli K-12 strain.
  • The BSO will review the request and if appropriate notify the IBC Chair of the pending amendment. If the IBC chair agrees that the changes are appropriate for an amendment and approves them as such, he/she will communicate this by approving the amendment; an email notification will be sent to the PI, authorized users and Biosafety Office.
  • Requests that involve significant changes to the protocol will be sent to the full IBC to be reviewed at the next regularly scheduled meeting.
  • Requests to add or delete staff to rDNARDs will be processed by the BSO without IBC Chair involvement. Prior to approval the BSO will ensure that all online training is complete for added staff. 

X. REFERENCES

  1. American National Standard for the Safe Use of Lasers, ANSI Z136.1, 2007.
  2. American National Standard for the Safe Use of Lasers in Healthcare Facilities, ANSI Z136.3, 2005.
  3. University of Waterloo, Ontario, Laser Safety Manual, 2000
  4. “OSHA Technical Manual – Section III, Ch. 6 Laser Hazards”, 2000
  5. “UC Berkeley Laser Safety Manual”, 1998
  6. “Iowa State University Laser Safety Manual,” Iowa State University, 1998.
  7. “Laser and Eye Safety in the Laboratory.” Matthews, Larry. New York: IEEE Press; Bellingham, Washington. SPIE Optical Engineering Press, 1995.
  8. “Safety with Lasers and Other Optical Sources”, Sliney and Wolbarscht, 1980
  9. “Laser Safety and the Eye”, Lions Laser Skin Center, Vancouver, 1996
  10. “Publication 3000 – Chapter 16 Lasers” Lawrence Berkeley National Lab, 1997

XI. Reporting of Adverse Events

  1. Investigators who have received approval from the FDA to initiate a human gene transfer protocol must report any serious adverse event (SAE) immediately to the local IRB, IBC and NIH OBA, followed by the submission of a written report filed with each group. The requirements for reporting SAEs in human gene transfer research are found in Appendix M-I-C-4 of the NIH Guidelines. The form to use in reporting SAEs is the Template for Reporting Adverse Events In Human Gene Transfer Trials.

  1. Reporting SAEs through the HAWK IRB system will inform the Director of EHS and the BSO of the submission through an automated email notification. The BSO will forward the information to the IBC Chair and IBC for discussion, if appropriate; events that are unexpected and possibly associated with the gene transfer product must be reported to OBA by the PI within 15 calendar days of sponsor notification, unless they are fatal or life threatening, in which they must be reported within 7 calendar days.

XII. Process for Reporting Violations of the NIH Guidelines

  1. Allegations regarding a violation of the NIH Guidelines could be reported through at least two routes:
  • A whistleblower (student, staff, or faculty who in good faith reports real or perceived University-related misconduct).
  • Biosafety staff, during the regular performance of his/her job duties, is informed or made aware of information that a violation of the NIH Guidelines may have occurred.
    • This entails that a staff member is given credible information that is more than mere hearsay. Staff should make reasonable efforts to inquire further about the possibility of a violation.
    • If found to be credible, further investigation will proceed as described below.
  1. Information received through either route requires that the Biosafety Office notify the IBC chair, the Institutional Official (IO) and the EHS Director. If the IBC chair, IO and EHS Director agree to proceed with an investigation, the Biosafety Office will be directed to investigate the allegation. Prior to initiating an investigation, the Biosafety Office shall provide the PI with written notice of the allegation and the plans for an investigation.
  2. Upon completion of the investigation, an investigation report will be prepared and sent to the IBC chair, the IO, and the EHS Director. If after careful review of the investigation report, a majority of these persons opines that the findings reasonably support the allegation of a violation, the investigation report will be sent to the members of the IBC for review.
  1. The investigation report will be considered at a meeting of the IBC convened for that purpose, or at a previously scheduled meeting if one will occur shortly after the report is sent to the IBC members. After consideration of the investigation report, the written materials submitted by the PI if any, and the information presented in person by the PI if any, the members in attendance will determine by majority vote if a violation of the NIH Guidelines has occurred.
  2. If the IBC determines that a violation of the NIH Guidelines has occurred, the IBC chair will prepare a violation report to be sent to NIH/OBA that will outline the review process followed, the findings of the investigation, and any measures that will be taken to reduce the likelihood of the occurrence of such violations in the future.
  3. Alternatively, the IBC chair may ask the PI if he/she wishes to prepare the violation report, as specified in the NIH Guidelines. If the PI chooses to prepare said report, the IBC chair will provide guidance in its preparation. If the IBC chair deems the report prepared by the PI to be unacceptable, the IBC chair will prepare his/her own report.
  4. Independent of who prepares the violation report, the IBC chair will ensure that it is sent to NIH/OBA within 30 days of the Biosafety Office’s becoming aware of the violation. Copies of the violation report will be sent to the IO and to the PI. The BSO will notify NIH/OBA of incidents requiring immediate reporting through an email; a full report will follow after the investigation has been completed.

 

  © THE UNIVERSITY OF IOWA 2013