9.1 Establishment of a Designated Area

For work involving particularly hazardous substances, laboratories should establish a designated area where particularly hazardous substances can only be used. In some cases, a designated area could be an entire room out of a suite of rooms, or could mean one particular fume hood within a laboratory. The idea is to designate one area that everyone in the laboratory is aware of where the particularly hazardous substances can only be used.

In certain cases of establishing designated areas, Principal Investigators and laboratory supervisors may want to restrict use of a particularly hazardous substance to a fume hood, glove box or other containment device. This information should be included as part of the laboratory’s SOPs and covered during in-lab training.

Establishing a designated area not only provides better employee protection, but can help minimize the area where potential contamination of particularly hazardous substances could occur. If a designated area is established, a sign should be hung up (on a fume hood for example) indicating the area is designated for use with particularly hazardous substances. Most designated areas will have special PPE requirements and/or special waste and spill cleanup procedures as well. These and other special precautions should be included within the lab’s SOPs.

9.2 Safe Removal of Contaminated Materials and Waste

Some particularly hazardous substances may require special procedures for safe disposal of both waste and/or contaminated materials. When in doubt, contact EHS at askEHS@cornell.edu to determine proper disposal procedures. Once these disposal procedures have been identified, they should be included as part of the laboratory’s SOPs and everyone working in the lab should be trained on those procedures.

9.3 Decontamination Procedures

Some particularly hazardous substances may require special decontamination or deactivation procedures (such as Diaminobenzidine waste or Ethidium bromide) for safe handling. Review SDSs and other reference materials when working with particularly hazardous substances to identify is special decontamination procedures are required. If they are required, then this information should be included in the laboratory’s SOPs and appropriate training needs to be provided to laboratory personnel who work with these chemicals.

9.4 Guidelines for Working with Particularly Hazardous Substances

Laboratory personnel should always use engineering controls, maintain good housekeeping, wear appropriate PPE, develop and follow SOPs, and complete required training when working with hazardous chemicals. The following additional precautions apply when working with Particularly Hazardous Substances (PHS), as defined by OSHA: acutely toxic chemicals, select carcinogens, and reproductive toxins.

• Substitute less hazardous chemicals whenever feasible to reduce or eliminate exposure to PHS.
• Obtain prior approval from the Principal Investigator before purchasing or using any PHS.
• Plan the experiment in advance, including workspace layout, required equipment, and waste containers.
• Review chemical safety information, including SDS Section 6 (Accidental Release Measures) and Section 13 (Disposal), and ensure appropriate spill cleanup materials and neutralizers are available.
• Select PPE appropriate for the specific chemical hazards (consult glove compatibility charts or contact EHS at askEHS@cornell.edu).
• Use the minimum quantity of PHS needed for the procedure to reduce exposure risk.
• Whenever possible, use premixed solutions to avoid handling powders. Powder handling must occur in a fume hood or ventilated balance enclosure. If engineering controls are not feasible, contact EHS—dust masks are not a substitute for respiratory protection.
• As a coworker protection measure, handle powders or dusty materials when others are not working in close proximity, and thoroughly decontaminate all work surfaces after handling.
• Use secondary containment such as trays for experiments and for chemical storage.
• Store PHS in clearly labeled, segregated areas (e.g., “Carcinogens,” “Reproductive Toxins”) consistent with the Laboratory Safety Manual and Cornell chemical storage guidelines.
• Maintain good personal hygiene, including thorough hand washing after glove removal and when leaving the laboratory.
• When vacuum assistance is required, use only vacuums equipped with HEPA filtration. Vacuum bags and filters contaminated with PHS may require disposal as hazardous waste.
• Conduct all work with PHS in a properly posted Designated Area with restricted access and clear hazard signage, as required by Cornell’s Laboratory Safety Manual.
• Ensure that all SOPs addressing the use of PHS include hazard information, designated areas, PPE requirements, waste procedures, and emergency response steps.

9.5 Prior Approval

The OSHA Laboratory Standard requires Chemical Hygiene Plans to include information on “the circumstances under which a particular laboratory operation, procedure or activity shall require prior approval”, including “provisions for additional employee protection for work with particularly hazardous substances” such as "select carcinogens," reproductive toxins, and substances which have a high degree of acute toxicity.

Prior approval ensures that laboratory workers have received the proper training on the hazards of particularly hazardous substances or with new equipment, and that safety considerations have been taken into account BEFORE a new experiment begins.

Principal Investigators or laboratory supervisors must identify operations or experiments that involve particularly hazardous substances (such as "select carcinogens," reproductive toxins, and substances which have a high degree of acute toxicity) and highly hazardous operations or equipment that require prior approval. They must establish the guidelines, procedures, and approval process that would be required. This information should be documented in the laboratory's or department's SOPs. Additionally, Principal Investigators and laboratory supervisors are strongly encouraged to have written documentation, such as “Prior Approval” forms that are completed and signed by the laboratory worker, and signed off by the Principal Investigator or laboratory supervisor and kept on file.

Examples where Principal Investigators or laboratory supervisors should consider requiring their laboratory workers to obtain prior approval include:

• Experiments that require the use of particularly hazardous substances such as "select carcinogens," reproductive toxins, and substances that have a high degree of acute toxicity, highly toxic gases, cryogenic materials and other highly hazardous chemicals or experiments involving radioactive materials, high powered lasers, etc. 
• Where a significant change is planned for the amount of chemicals to be used for a routine experiment such as an increase of 10% or greater in the quantity of chemicals normally used. 
• When a new piece of equipment is brought into the lab that requires special training in addition to the normal training provided to laboratory workers. 
• When a laboratory worker is planning on working alone on an experiment that involves highly hazardous chemicals or operations.

9.6 Campus Prior Approval

There are some circumstances where prior approval from a campus research related committee is required before beginning an operation or activity. These include:

• Research using live vertebrate animals:
  • contact the Institutional Animal Care and Use Committee at 607-253-3516. 
• Recombinant DNA use:
  • contact the Institutional Biosafety Committee at 607-255-5013. 
• Use of Radioactive Materials:
  • contact the EHS Radiation Safety Group at 607-255-8200. 
• Use of Human Subjects:
  • contact the University Committee on Human Subjects at 607-255-5138. 
• Purchases involving Poison Inhalation Hazards:
  • see the Cornell University Poison Inhalation Hazard Purchasing Policy – Requisitioning Procedure No. 228.

Additional information can be obtained from the Office of Research and Integrity Assurance webpage for Compliance with Government Regulations.

9.7 Select Carcinogens

A carcinogen is any chemical, biological agent, or exposure that can cause cancer through the initiation or promotion of abnormal cell growth in humans or animals. Many carcinogens act as chronic health hazards, with effects that may not appear until years after exposure. Because cancer risk often increases with the amount and duration of exposure, it is important to minimize contact with all known or suspected carcinogens.

Under the OSHA Laboratory Standard (29 CFR 1910.1450), a select carcinogen is any substance that meets one or more of the following criteria:

1. It is regulated by OSHA as a carcinogen; or
2. It is listed as “known to be a human carcinogen” in the latest National Toxicology Program (NTP) Report on Carcinogens; or
3. It is listed by the International Agency for Research on Cancer (IARC) as Group 1 (“carcinogenic to humans”); or
4. It is listed as IARC Group 2A (“probably carcinogenic”) or Group 2B (“possibly carcinogenic”), or is classified by NTP as “reasonably anticipated to be a human carcinogen.”

OSHA also requires that mixtures be assumed carcinogenic if they contain a carcinogenic component at concentrations of 0.1% or greater, unless evidence demonstrates otherwise. When working with carcinogens, personnel must follow Cornell’s Guidelines for Working with Particularly Hazardous Substances (PHS) .

The likelihood that a carcinogen may result in adverse health effects depends on the type of carcinogen, the route and duration of exposure, and individual susceptibility. Other factors that can influence cancer risk include inherited genetic conditions, certain medications, tobacco use, alcohol consumption, and environmental exposures such as ultraviolet radiation.

Additional information about carcinogens—including OSHA-regulated carcinogens and hazard classifications—can be found on the OSHA Carcinogens webpage. The State of California maintains a comprehensive list of carcinogens under Proposition 65, which may be useful for reference but is not a regulatory requirement in New York State.

9.8 Reproductive Toxins

A reproductive toxin is a chemical, biological, or physical agent that can adversely affect reproductive function, fertility, pregnancy outcomes, or fetal development. These effects may occur through impacts on reproductive organs, gamete production, hormone regulation, or embryo–fetal development. Reproductive toxins can affect people of all genders.

It is important to understand which hazardous materials are used in laboratory procedures. Many reproductive toxins are chronic health hazards, meaning adverse effects may occur after repeated or prolonged exposure. Individuals who are pregnant or may become pregnant—as well as those planning families—should take extra care when handling known or suspected reproductive toxicants.

EHS provides free and confidential consultation services for individuals with concerns about workplace exposures, engineering controls, work practices, or PPE related to reproductive hazards. Assistance can be requested by completing the Reproductive Health Questionnaire or by visiting the Reproductive Health webpage.

The following precautions should be taken when working with reproductive toxins or other potentially hazardous materials:

• Wear appropriate personal protective equipment (PPE), including gloves, eye protection, and a lab coat.
• Select gloves based on compatibility with the specific chemical hazards (consult SDS Section 8).
• Do not eat, drink, chew gum, or apply cosmetics in areas where hazardous materials are used.
• Maintain an accurate chemical inventory and ensure containers are clearly labeled.
• Plan each procedure in advance and ensure appropriate engineering controls and PPE are available.
• Use the minimum quantity of reproductive toxicant necessary for the procedure.
• Conduct work involving reproductive toxins in a designated or controlled area as described in the Laboratory Safety Manual for Particularly Hazardous Substances (PHS).
• Use appropriate engineering controls such as fume hoods, biosafety cabinets, ventilated enclosures, or glove boxes when handling hazardous materials. If these are not feasible, contact EHS regarding respiratory protection requirements.
• Ensure work surfaces are cleanable and, when necessary, protected with impervious or disposable coverings.
• Wash hands and forearms thoroughly after completing work and clean all contaminated surfaces and equipment.
• Do not wear contaminated PPE outside the laboratory or designated work areas.
• Transport waste containers in a secondary container to prevent contamination during removal from the controlled area.
• If medical evaluation is needed, provide your healthcare provider with relevant SDSs and procedural information.

9.9 Acute Toxins

OSHA defines a chemical as being highly toxic if it falls within any of the following categories:

1. A chemical that has a median lethal dose (LD50) of 50 milligrams or less per kilogram of body weight when administered orally to albino rats weighing between 200 and 300 grams each. 
2. A chemical that has a median lethal dose (LD50) of 200 milligrams or less per kilogram of body weight when administered by continuous contact for 24 hours (or less if death occurs within 24 hours) with the bare skin of albino rabbits weighing between two and three kilograms each. 
3. A chemical that has a median lethal concentration (LC50) in air of 200 parts per million by volume or less of gas or vapor, or 2 milligrams per liter or less of mist, fume, or dust, when administered by continuous inhalation for one hour (or less if death occurs within one hour) to albino rats weighing between 200 and 300 grams each.

Information on determining whether or not a chemical meets one of these definitions can be found in SDSs and other chemical references. 

As with any particularly hazardous substance, work involving the use of acute toxins should adhere to the Guidelines for Working with Particularly Hazardous Substances. In addition to following the Guidelines for Working with Particularly Hazardous Substances, additional guidelines for working with acute toxins include:

• Consider storing highly toxic materials in a locked storage cabinet.
• Be aware of any special antidotes that may be required in case of accidental exposure (Hydrofluoric acid and inorganic cyanides for example).
• Give particular attention to the selection of gloves and other personal protective equipment. 
• Do not work with highly toxic chemicals outside of a fume hood, glove box or ventilated enclosure.

More information on acute toxins, including numerous useful web links, can be found on the OSHA Safety and Health Topics for Hazardous and Toxic Substances webpage.