This chapter supplements previous chapters by giving specific extra precautions, postings, training, and protective equipment necessary when working with reproductive hazards. These include chemical, biological, or radiological substances that can affect the developing fetus, or the reproductive health of the male or female parents. This chapter also outlines the UNC conceptus protection policy for laboratory workers who are pregnant or contemplating pregnancy. The appendix at the end of the chapter is a thorough (but not exhaustive) list of known reproductive toxins that might be present in your laboratory.

Work with reproductive hazards requires special containment practices in addition to those described in Chapter 6 for toxic chemicals and in the Biological Safety Manual. Reproductive hazards are defined by the OSHA Laboratory Standard as substances that cause chromosomal damage (mutagens) and substances with lethal or teratogenic (malformation) effects on fetuses. These can include chemicals, biological materials, and radioactive materials. The University policy for protecting pregnant employees is provided later in the section entitled “Reproductive Hazards and the Pregnant Employee”. For a list of known reproductive toxins, refer to Appendix 8-A.
Laboratories working with reproductive hazards must include standard operating procedures in the Laboratory Safety Plan describing the hazards of the compounds or agents, safety precautions and emergency procedures in the event of a spill. Complete and submit a Laboratory Safety Plan online. In addition to the safety practices described for use of toxic materials, several other special safety precautions are necessary for reproductive toxins.
Establish a “designated area,” with access restricted to personnel who are aware of the hazards of the substances in use and the necessary precautions. A foot or elbow operated handwash facility and an eyewash facility must be available within the work area. A shower facility, other than emergency drench showers, must be located in the building.

Exhaust ventilation systems are designed to maintain an inflow of air from the corridor into the work area. The exhaust air from the work area must discharge directly to the outdoors, and clear of occupied buildings and air intakes. Exhaust air from the work area must not recirculate. The exhaust air from glove boxes must filter through high-efficiency particulate air (HEPA) and charcoal filters. EHS shall determine the need for and type of treatment for other primary containment equipment. Exhaust air treatment systems that remove toxic chemicals from the exhaust air by collection mechanisms such as filtration or absorption must operate in a manner that permits maintenance, in order to avoid direct contact with the collection medium. All exhaust air from primary containment equipment must discharge directly to the outdoors and disperse clear of occupied buildings and intakes. The EHS Director (or designee) must approve the purchase and installation of any non ducted hoods. Non-ducted hoods will not be approved for use with volatile chemicals. Approval will be granted only in exceptional cases, and only when particulate handling (e.g., weighing solids) is its sole use.

Refer to Chapter 5: Protective Clothing and Equipment

Wear a full-fastened laboratory coat or a disposable jump suit in any area where known or suspected reproductive toxins are in use. Clean clothing must be provided weekly and cannot be worn outside of the work area. Following an obvious exposure, decontaminate or dispose immediately all contaminated clothing. Do not send contaminated clothing to the laundry until decontaminated. Wear appropriate gloves (LSM Appendix 5-B) when handling reproductive toxins. EHS recommends double gloving. Discard disposable gloves after each use and immediately after known contact with a reproductive toxin.

Procedures involving volatile chemicals, and those involving solid or liquid chemicals that may result in the generation of aerosols, must occur in a laboratory hood, biological safety cabinet, glove box, or other suitable containment equipment. Examples of aerosol-producing procedures include: opening closed vessels; transfer operations; weighing; preparing feed mixtures; and the application, injection or intubation of a chemical into experimental animals. Class II, type B biological safety cabinets are suitable for the conduct of tissue culture and other biological procedures involving reproductive toxins. The Principal Investigator is to obtain guidance from EHS on the selection and use of Class II biological safety cabinets. For more information on biological safety cabinets, refer to Chapter 16: Biological Safety Cabinets. Primary containment equipment used for reproductive toxins must display a label bearing the legend: CAUTION – REPRODUCTIVE TOXIN, Authorized Personnel Only. The examples below in Figure 8.1, Figure 8.2, and Figure 8.3 are available on the EHS Safety Labels webpage for printing.

A clean bench (Chapter 16, Section III) is a laminar flow cabinet that provides a flow of filtered air over the work service and offers product protection, not personnel protection. Do not use reproductive toxins in them. Clean benches are posted by the lab or EHS with the following information (Figure 8.2):

Figure 8.1
Figure 8.1. Label for storage areas or primary containment equipment where reproductive toxins are present.
Figure 8.2
Figure 8.2. Example posting for clean benches.
Analytical instruments used with reproductive toxins must be entirely within a laboratory hood. When this is impossible, capture the vapors or aerosols produced by these instruments through local exhaust ventilation at the site of their production. When you remove a sample from the analytical instrument, place it in a tightly stoppered sample tube, or otherwise safeguarded from contaminating the laboratory. Do not use contaminated analytical equipment until it has been completely decontaminated. The following are some decontamination guidelines. Contact EHS if you have additional questions about equipment decontamination.

Safely remove, drain, or discharge chemicals from the equipment, collecting the chemicals for re-use or hazardous waste disposal. If applicable, use an inert gas or liquid to purge the chemical residues. In some cases, the rinsate might require disposal as hazardous waste. For equipment with non-permeable surfaces, decontaminate by scrubbing with warm, soapy water. For equipment that also might contain biological contamination, follow the soapy water wash with a 1:10 bleach solution soak. Rinse the equipment after at least 10 minutes contact time with the bleach.

Store stock quantities of reproductive toxins in designated storage areas. Post these storage areas with signs bearing the legend: CAUTION – REPRODUCTIVE TOXIN, Authorized Personnel Only (Figure 8.1).

Label all storage vessels containing stock quantities with the following information: CAUTION – REPRODUCTIVE TOXIN (Figure 8.3 or similar). This smaller label, which does not include the “Authorized Personnel Only” statement necessary for containment equipment or storage areas, is available at EHS Safety Labels webpage.

Figure 8.3
Figure 8.3. Label for storage vessels that contain reproductive toxins.
Keep quantities of reproductive toxins in the work area to a minimum. Quantities should not normally exceed the amounts required for use in one week. Use the label depicted in Figure 8.3 (or similar) for storage vessels containing working quantities of reproductive toxins.
Place storage vessels containing reproductive toxins in an unbreakable outer container before transporting them from storage areas to laboratory work areas. Place contaminated materials to transfer from work areas to disposal areas in a closed plastic bag or other suitable impermeable and sealed primary container, and place the primary container in a durable outer container before transporting. Label the outer container with both the name of the substance and the hazard information from Figure 8.3.
Each vacuum service, including water aspirators, must have protection via an absorbent or liquid trap and a HEPA filter to prevent entry of any reproductive toxin into the system. When using a volatile chemical, use a separate vacuum pump or other device placed in an appropriate laboratory hood.
Package reproductive toxins to withstand shocks, pressure changes, or other conditions that could cause the leakage of contents incident to ordinary handling during transportation. Shipments must be in accordance with DOT and IATA regulations. These regulations state that you must receive specific training in order to ship a hazardous material. The EHS website has more information regarding training and guidance on shipping and labeling.
Before disposing you must inactivate, or absorb by appropriate means, in situ reproductive toxins that spill out of a primary container and create a hazard. Contaminated materials require either decontamination by procedures that decompose the chemical, or removal for subsequent disposal. Means for assuring the adequacy of clean up are required; for instance, wipe tests or fluorescence tests.
EHS must approve all plans for handling and ultimate disposal of contaminated wastes. Write these into the Laboratory Safety Plan, Schedule B, and fully describe the reproductive toxins in your waste stream when submitting an online hazardous materials transfer form. Refer to Chapter 12: Management of Laboratory Wastes for additional guidance.
In all circumstances, research and animal care personnel must wear a disposable jumpsuit or lab coat, shoe coverings, hair covering, gloves, and a respiratory comfort mask when entering DLAM animal housing facilities or procedure rooms (refer to Chapter 14: Safe Handling of Laboratory Animals). As discussed in Chapter 5, comfort masks are not respirators. The comfort masks provided in several DLAM facilities do not protect you from airborne exposures; instead, they protect the laboratory animals from your exhalations. Personnel with exposure to airborne particulates contaminated with reproductive toxins without the use of primary containment must wear an appropriate respirator of N95 or higher protection, rather than a comfort mask. Refer to the Respiratory Protection section of Chapter 5: Protective Clothing and Equipment, for a description of respirator types.

EHS must approve the selection and use of respirators, and wearers are to participate in the UNC Respiratory Protection Program.

Do not wear the comfort mask or respirator outside of the animal room or procedure room. For tight-fitting cartridge respirators, dispose of used filters and decontaminate the respirator housing daily.

Reproductive toxins are defined by the OSHA Laboratory Standard as substances that cause chromosomal damage (mutagens) and/or substances with lethal or teratogenic (malformation) effects on fetuses. Teratogens may affect the conceptus at any stage of its development, from fertilization to birth, although damage is most likely during the first 8 to 10 weeks of pregnancy. Mutagens can also affect conceptus development, or prevent fertilization entirely by damaging the egg or sperm. In addition, there are microbiological agents that can cause maternal morbidity, miscarriage, fetal death or birth defects.

Teratogens are chemical and physical agents that interfere with normal embryonic development. Teratogens differ from mutagens in that there must be a developing fetus. Reproductive toxins may produce congenital malformations or death of the fetus without inducing damage to the pregnant woman. In general, you should consider carcinogenic, mutagenic and teratogenic chemicals hazards to reproductive health. Even though OSHA has established hazardous material exposure limits, a developing fetus can suffer adverse effects at lower doses than those considered safe for adults. Thus, you must keep exposures as low as reasonably achievable to minimize reproductive health hazards.

UNC is committed to providing additional protection for the conceptus, and establish specific procedures to protect pregnant employees. Control of employee exposures will occur without economic penalty or loss of job opportunity, including, if necessary, consideration for work assignment changes, consistent with University personnel policy. Assuring protection from exposures to radiation and/or chemicals for the conceptus requires full cooperation of the employee with the Department of Environment, Health and Safety (EHS). If you wish to take advantage of this policy, contact EHS as soon as possible after determining or contemplating pregnancy, to ensure implementation of these policies.

A thorough list of known reproductive toxins is found in Appendix 8-A to this Chapter. This list includes agents that cause fetal developmental toxicity, damage the male/female reproductive cells, or other difficulty with conception. Examples of reproductive toxins commonly found in laboratories include:

  • 1,3-Butadiene
  • Ethylene thiourea
  • Arsenic
  • Fluorouracil
  • Benzene
  • Halothane
  • Cadmium
  • Ionizing radiation
  • Carbon disulfide
  • Lead
  • Dibromochloropropane
  • Mercury compounds
  • Ethylene dibromide
  • Polychlorinated biphenols (PCBs)
  • Ethylene glycol monomethyl (and ethyl) ethers
  • Toluene
  • Ethylene oxide
  • Urethane

Please refer to Appendix 8-A for a thorough listing.

Certain microbiological agents can cause miscarriages, fetal death and birth defects. Employees can be exposed to these agents via splashes or contact with mucous membranes, needlesticks or ingestion. The following agents are known to be reproductive hazards:

  • Cytomegalovirus (CMV). CMV is a known teratogen and congenital infection can cause mental retardation, cerebral palsy, epilepsy, vision and hearing problems especially during the first 20 weeks of fetal development.
  • Hepatitis A, B, C. Prenatal infection can cause prematurity and psychomotor retardation.
  • Human Immunodeficiency Virus (HIV). HIV can affect fertility. HIV can also be transmitted to the fetus.
  • Human Parvovirus (Fifth Disease). Prenatal infection with human parvovirus can cause fetal edema and death. Intrauterine infection may cause fetal anaemia.
  • Listeria monocytogenes. This bacterium is found in a variety of animals including mammals and birds so is of special concern to employees handling animals. Perinatal infections occur transplacentally and can result in abortion, stillbirth, meningitis, endocarditis, or septicemia.
  • Rubella virus (German measles). Congenital rubella syndrome (CRS) may occur in infants born to women who had rubella during the first trimester. This can lead to fetal death, spontaneous abortions, congenital malformations of the eyes, ears and heart, mental retardation and/or poor childhood growth. The risk decreases with fetal development.
  • Toxoplasma gondii (toxoplasmosis). Congenital cases can result in abortion and stillbirth. Live births may result in central nervous system disorders, hydrocephaly, or mental retardation. Transplacental infection is least likely during the first trimester, but these cases are the most severe. Cats can carry this disease and employees conducting experiments with cats may need to take additional precautions.
  • Varicella virus (Chicken Pox). Congenital infection can cause limb atrophy, microcephaly, cortical atrophy, motor, sensory and eye problems. Infection during the first trimester can cause miscarriage, muscular atrophy, clubbed foot, CNS disease and cataracts in the fetus.

This list is not all-inclusive and EHS will evaluate work exposures to all infectious materials once an employee has declared her pregnancy.

If you wish the University to be involved in protecting your fetus, and exposures to the fetus kept below the 500 millirems limit if you are a radiation worker, you must declare your actual, suspected, or planned pregnancy to your supervisor and EHS in writing, or by e-mail. The University’s responsibility for conceptus protection begins only after receipt of this notice of pregnancy, or intended pregnancy, to your supervisor and EHS. The involvement of supervisors is an essential part of the University’s safety management. EHS urges every potentially pregnant employee to consider her supervisor’s safety responsibilities and freely involve the supervisor in all work-related situations.
Following written or e-mail notice of pregnancy or intended pregnancy to the EHS Director, Biological Safety Officer, Chemical Hygiene Officer, or Radiation Safety Officer (RSO), EHS institutes a Conceptus Protection Program (CPP). The CPP consists of three elements.

1. Confidential Conferences

Conferences include the employee, her supervisor, and EHS specialists. The employee is provided a copy of this policy and other pertinent literature on protecting pregnant employees from chemical, biological and radiological exposures. Following the conference, EHS sends an assessment report to the employee and supervisor relating findings and recommendations of work involving hazardous materials. In some cases, adjustments should be made in work responsibilities, if practicable, to avoid higher risk operations.

An additional interview is available with an occupational health nurse or physician at the University Employee Occupational Health Clinic. This interview allows the employee to express concerns and to ask questions about reproductive and developmental health. A review of an occupational and reproductive health questionnaire facilitates collection of employee-specific information, assists the employee in formulating concerns about chemical and physical hazards, and provides structure and focus for the interview. A preconception planning stage is also available. Obstetric specialists are available for consultation or referral for any specific concerns.

EHS understands that employees may choose to maintain their pregnancy status as personally confidential for a time. Any employee may still receive safety information about pregnancy and chemical, biological, and radiological exposures at any time from EHS without declaring her pregnancy status.

2. EHS Review of Laboratory Safety

EHS will conduct a review of the laboratory or worksite safety plan to ensure that it provides appropriate guidance to protect workers and prevent occupational exposures. EHS inspects the work place to ensure that adequate engineering controls, such as laboratory hoods, are provided, and that safe handling procedures and the use of personal protective equipment are in place. Employees have the responsibility of adhering to University safety procedures described in the Laboratory (or worksite) Safety Plan, the Health and Safety Manual, Laboratory Safety Manual, Biological Safety Manual and the Radiation Safety Manual.

3. Radiation and Chemical Exposure Monitoring

EHS will monitor employee exposures levels for radiation and any chemicals of concern, especially those with evidence of reproductive toxicity. The employee and principal investigator, or supervisor, shall receive a copy of the monitoring report. The goal is to keep all exposures as low as reasonably achievable.

EHS performs the personnel radiation monitoring through the Radiation Safety section. EHS assigns the radiation employee a monthly radiation badge and/or places her on a monthly bioassay program.

1. Radiation Exposures

Current investigational radiation dose limits for declared pregnant or planned pregnancy employees will direct the RSO in evaluating reported doses. The North Carolina Regulations for Protection Against Radiation has established a radiation dose limit of 500 millirems for the conceptus during the entire gestation period.

Action Level I:

Employees with exposures greater than 30 millirems in a month. The RSO or designee shall send a written description of the dose report statistics, including the dose history for the previous two monitoring periods, to the person involved with a copy to the Authorized User. EHS asks the individual and their supervisor to review his or her radiation safety procedures and work habits in an effort to maintain all doses as low as reasonably achievable. Health physics reviews and consultation are available.

Action Level II:

Greater than 40 millirems in a month. The RSO shall conduct a direct investigation of the situation, including an interview with the person involved. The RSO prepares a written investigation report, including trends over the past one year (as available) for that person. The RSO provides a copy of the report to the employee for review and signature. Conclusions drawn from the investigation provide a basis for confirming or modifying the dose and for establishing corrective actions to undertake.

When the occupational radiation dose of a declared radiation employee exceeds 50 millirems in a month since declaration, the employee may request:

  • Maternity leave (for those employees actually pregnant)
  • Other paid leave
  • Leave without pay
  • Reassignment within their work unit
  • Transfer

The supervisor should respond to requests in accordance with Human Resources personnel policies.

EHS and the Radiation Protection Section of the NC Department of Environment and Natural Resources accept doses reported from personnel monitoring badges generally as an uncorrected guide to any conceptus dose. If personnel monitoring results indicate the possibility of a conceptus dose in excess of the 500-millirem limit, a special investigation will result. The investigation will take into full consideration the type and energy of radiation involved, protective shielding that might have mitigated conceptus dose, and shielding afforded by the mother’s body. The employee and EHS will discuss the investigation results, and a written report provided.

2. Chemical Exposures

As stated earlier, the goal is to keep all exposures to both radiation and chemicals as low as reasonably achievable. The actions taken in response to a measured chemical exposure depend on the specific circumstances and chemicals involved. However, as a general rule, if any exposure measurements exceed 10% of the threshold limit value (TLV) or permissible exposure limit (PEL) action will be taken to prevent further exposure by instituting engineering controls, improved work practices, personal protective equipment (PPE), or job reassignment.

3. Microbiological Exposures

There are no action levels for microbiological agents. Many of the agents listed above can be safely handled at Biosafety Level 2 practices and containment (culturing HIV requires Biosafety Level 3 practices). Biosafety Level 2 practices include wearing gloves, labcoats and eye protection, conducting any aerosol generating procedures inside of a biological safety cabinet, decontamination of surfaces, frequent handwashing, and no eating, drinking, smoking or handling contacts in areas where infectious materials are handled. Please refer to the UNC Biological Safety Manual for more detailed information. These practices are required to protect the employee; however, some procedures conducted in the laboratory may be higher risk for pregnant employees and should be evaluated by EHS. In addition, the risks to the fetus from exposure to these pathogens may warrant restriction from use during a pregnancy. EHS in consultation with the employee and their supervisor will determine when restriction or additional personal protective equipment is necessary.

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