Chapter 8: Reproductive Hazards
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.
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.
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.
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):
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.
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.
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.
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.
- Ethylene thiourea
- Ionizing radiation
- Carbon disulfide
- Mercury compounds
- Ethylene dibromide
- Polychlorinated biphenols (PCBs)
- Ethylene glycol monomethyl (and ethyl) ethers
- Ethylene oxide
Please refer to Appendix 8-A for a thorough listing.
- 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.
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
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.