Managing Reproductive and Developmental Hazards
Elements of a Successful Workplace Program
Above: Examples of reproductive hazards include ethylene oxide, used to sterilize medical instruments (top left); antineoplastic drugs (bottom left); formaldehyde (top right); and radiation (bottom right).
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Although they receive relatively little attention, hazards that affect human reproductive systems and development can be devastating and should be managed with great care and sensitivity. According to NIOSH, exposures to these hazards, which can be chemical, biological, or physical, may negatively affect male and female fertility, pre- and post-natal outcomes, and menstrual and ovulation cycles. These hazards are present in many workplaces but are of particular concern in laboratories, where the number of chemicals in use can far exceed that in other occupational environments.
Examples of chemical reproductive hazards common in laboratories include formaldehyde, ethylene oxide, and antineoplastic drugs. But health and safety professionals can’t always rely on a short list of known hazards when assessing risk. Thousands of chemicals are used around the world, and many are likely to be unknown reproductive hazards. In addition, infectious biological agents manipulated and handled in laboratories, such as Coxiella burnetti (the causative agent of Q fever) and Listeria, have been shown to impair pregnancy outcomes.
Institutions must protect laboratory staff from the plethora of known and unknown reproductive hazards in the work environment. A reproductive and developmental health program to help identify and manage the risk is an important element of worker health and safety that extends beyond the workplace. For an example of such a program, visit the University of Pennsylvania’s Environmental Health and Radiation Safety department website.
For radiation, which is one of the better-known reproductive and developmental hazards, regulations specify how to manage pregnant workers’ exposure, including monitoring for both the expectant parent and developing fetus. Since there are only a handful of reproductive hazards, such as radiation, addressed by regulations, it should come as no surprise that workplace policies, training, mitigations, and assessments may not properly and proactively inform and protect employees. OEHS professionals should take steps to prioritize the development of such programs and processes.
Important elements of a reproductive and developmental health program include defining the roles and responsibilities of key partners, identifying reproductive and developmental hazards, conducting holistic hazard and risk assessments, managing exposures, and training workers. Some of these elements are further discussed below.
Roles and responsibilities. Managing reproductive and developmental hazards requires coordination with the human resources and legal departments. Identifying who does what and when is vital to a successful program and can alleviate challenges when a sensitive situation arises.
Hazard identification. With the exception of well-known hazards such as radiation, ethylene oxide, and formaldehyde, identifying reproductive and developmental hazards is difficult because chemicals typically appear in commerce long before thorough studies of their toxic effects are published. Thus, it is always a good practice to reduce chemical exposures to “as low as reasonably achievable” (ALARA) levels.
Often, the most readily available resource for information about chemicals is the safety data sheet. Reproductive and developmental hazards are supposed to be identified in the section on toxicological information, which includes subsections for germ cell mutagenicity, reproductive toxicity, teratogenicity, and specific target organ toxicity for both single and repeated exposures. However, these subsections often specify that no data are available for many of the toxicological endpoints.
If no data are available from the SDS, data banks such as PubChem and resources like NIOSH and ACGIH have literature available on specific chemical hazards. In addition, toxicologists typically have a wealth of data at their fingertips. They can help identify reproductive and developmental hazards and determine whether publicly available exposure limits adequately protect pregnant workers.
Exposure management. The program should establish a method and workflow for addressing the hazard and controlling the exposure. The method can be either proactive or reactive.
Case Study: Change to SDS Sparks Review A manufacturing company became aware that new information published by a raw material supplier in its SDS indicated that the chemical used in one process was now classified as a reproductive and developmental hazard. The chemical, which did not have a publicly available exposure limit, had been used for decades across several manufacturing sites in different countries. Fortunately, the process required supplied-air respiratory protection due to other hazards previously identified in exposure assessments.
While the company took steps to determine whether the exposures were acceptable, the health and safety professional partnered with a communications expert to inform affected employees. The health and safety professional met individually with the affected employees and allowed them to share concerns and ask questions. HR was also heavily involved in the communication and helped develop talking points for company leadership.
Following the communication, the health and safety professional partnered with the toxicologist to develop an exposure limit for the chemical. After performing a complete review of the peer-reviewed research, the toxicologist recommended separate exposure limits for non-pregnant workers and pregnant workers, which the company adopted. With the limits defined, the resident industrial hygienist conducted a sampling campaign in all manufacturing areas. The exposure assessment had a positive outcome: the results fell well below the defined exposure limits and were deemed acceptable due to ventilation controls and process enclosures.
The proactive approach involves a process like the one used in workplaces—laboratories in particular—to identify biological or infectious agents. The OEHS professional uses a chemical inventory or database to identify the reproductive and developmental hazards within the work environment and then applies a qualitative and quantitative risk assessment to all identified chemicals. For a case study of the proactive approach, see the sidebar above.
The reactive approach involves addressing questions as they arise from concerned workers or researchers. In many cases, the OEHS professional will direct workers to consult with health professionals or other pertinent groups within the organization. This approach focuses on chemicals used by the worker as opposed to the whole work environment and involves interviewing the worker to identify where he or she works, what hazardous chemicals he or she may use, what work practices he or she follows, and other control methods.
Both the proactive and the reactive approach can use an existing risk assessment process for all hazards. If the assessment determines that additional controls are warranted, the OEHS professional should work with the appropriate groups to implement the controls, both interim and long term. These groups may object that, for example, implementing additional controls to protect a single worker for the relatively short term of a pregnancy is inefficient and expensive. In these cases, the OEHS professional can respond that controls benefit all employees. If the risk is found to be unacceptable for any individual, appropriate actions would need to follow an approved process defined by the HR and legal departments.
It is important to note that exposures to reproductive hazards can be indirect, as discussed in a 1984 paper in the Canadian Medical Association Journal that outlined the prevalence of Q fever cases among staff extending from seropositive sheep housed in a facility for research animals. According to this study, out of 331 staff members tested, almost 20 percent were seropositive. While seropositivity among staff was highly correlated with direct work with sheep, 59 of the seropositive employees had no contact with sheep. Presumably, these staff were exposed via aerosolized C. burnetti in housing areas such as offices located along the corridor used to transport sheep.
Training. Workplace programs are only as effective as the training and hazard information provided to workers and individuals with defined roles and responsibilities. At the very least, workers need to know how to raise a concern about reproductive and developmental hazards. While the main issue with these hazards is their effects on fertility, all employees and researchers, regardless of their interest in having children, should be aware of these hazards and informed that the employer or institution has established a process to address them.
Training should be provided not only to the general workforce but to those participating in the risk assessment and exposure management processes. Vital to this training is how to handle sensitive and confidential information; those involved in the process should approach employee concerns with extreme care. For both male and female workers, reproductive health is a private matter. Pregnant workers may fear they will lose their job because of their pregnancy and that the confidentiality of their personal health information is at the mercy of their supervisor and the company’s adherence to the Health Insurance Portability and Accountability Act (HIPAA). They may wonder who they can trust to get the information they need to ensure their safety and the safety of their fetus.
Other considerations. As you develop your program, make sure to consult with the legal and HR departments to ensure the program does not conflict with any laws. It is equally important to ensure that confidentiality is maintained throughout all programmatic elements. Employees who raise concerns about reproductive hazards and risks must be protected from retaliation.
Prenatal care can be an important resource for pregnant individuals. It is common in the developed world to start prenatal care early in the first trimester, which is particularly susceptible to reproductive and developmental hazards. Obstetricians provide the needed care to ensure the health of the pregnant person and unborn child, but they often do not have access to workplace chemical exposure information. In accordance with the “right to know” principle delineated in OSHA’s Hazard Communication Standard, employers should develop a process for managing questions and providing information to workers that includes resources such as onsite medical staff (if available), health and safety professionals, and human resources.
TOOLS FOR SENSITIVE SITUATIONS As previously mentioned, work groups throughout the institution or organization are not always equipped with information and tools to handle situations resulting from potential exposure to reproductive or developmental hazards. Developing a program that defines responsibilities and provides training for responsible individuals will help these groups respond appropriately.
APRIL CLAYTON is a senior research safety manager at the Children’s Hospital of Philadelphia.
DIANA PERONI is a senior environmental health, safety, and sustainability manager at BioMarin Pharmaceutical.
GARTH GRAHAM is the industrial hygiene and occupational health leader for AdvanSix.
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Editor's note: An earlier version of this article incorrectly stated that radiation is the only reproductive hazard addressed by OSHA standards. The article was updated on Aug. 9, 2021.
Murika/Getty Images, tashatuvango/Adobe Stock, Stock, panumat polsawat/ Getty Images
Canadian Medical Association Journal: “Q Fever: Hazard from Sheep Used in Research” (April 1984).
NIOSH: “Reproductive Health and the Workplace.”
The Synergist: “Windows of Susceptibility: Do OELs Really Protect Workers from Reproductive and Developmental Effects?” (June 2016).
University of Pennsylvania Environmental Health and Radiation Safety: “Reproductive Health.”