Laboratory Reproductive Health Hazards Guidance Document

Introduction and Background

Certain chemicals, biological materials, and physical hazards in the laboratory can cause negative effects to both male and female reproductive systems, fertility, and can affect the developing fetus as well as impact the infant. Female exposure to these materials can reduce fertility, induce early menopausal symptoms, cause damage to the fetus, and broadly cause damage to the reproductive system. Male exposure to reproductive hazards has also been found to damage the reproductive system, reduce fertility, and cause genetic effects to the sperm resulting in miscarriages or birth defects. The following guidance is for may be exposed to chemical or biological reproductive toxicants when working in a laboratory setting, including those who are or may plan to become pregnant.

* Note: Separate precautions may be taken if declaring pregnancy while working with radioactive materials, see EHS Radiation Safety Website for additional information on radiological hazards.

Exposure to reproductive hazards can affect fetal development at all stages of pregnancy, with the first trimester being the most sensitive stage where all organs are developed. Lab workers are urged to initiate the process described below as soon as they (or their partner) contemplate becoming pregnant or believe they are pregnant.

Definitions

Types of Reproductive Hazards

Reproductive hazards can be biological, chemical, and/or physical (including radiological).

• Biological:
  • Lab workers may be potentially exposed to various occupational hazards that could affect reproductive health. Certain microbiological agents can cause hazards to reproduction, typically by causing infections upon exposure and may lead to damage to the reproductive system or the fetus, including miscarriages, death of the fetus, or birth defects. Working in the laboratory with these agents requires prior approval by the BU Institutional Biosafety Committee (IBC), medical clearance from the Research Occupational Health Program (ROHP) and use of the agent in an appropriate Biosafety Containment Level and Practices.
• Chemical:
  • Reproductive toxicants: also referred to as reproductive toxins, are defined as chemicals that affect the reproductive capabilities including adverse effects on sexual function and fertility in adult males and females, as well as adverse effects on the development of the offspring. Chemicals classified as reproductive toxins in accordance with Appendix A — Health Hazard Criteria (Mandatory) of the Hazard Communication Standard (§1910.1200) shall be considered reproductive toxins for purposes of this document.

For the laboratory worker, this means chemicals that can adversely affect people’s reproductive systems and/or capabilities including pregnancy outcomes. Exposure to these chemicals can have, but are not limited to, the following adverse effects: reduced fertility including sterility; chromosomal damage (mutations); effects on fetuses (teratogenesis and developmental toxicity); reproductive cycle abnormality; effects on pregnancy, delivery, and/or lactation, and other developmental toxicity.

• Developmental Toxicants/Teratogens: Are a subset of reproductive toxicants and are of increased concern during a pregnancy. Developmental toxicity is the property of a chemical that causes in-utero death, structural or functional abnormalities, or growth retardation. Exposure can occur prior to conception, during gestation, or up to the time of sexual maturity. Teratogens of special concern are associated with GHS codes H360D and H360FD.
• Germ Cell Mutagens: Chemicals that cause permanent, and potentially heritable, changes in the amount or structure of the genetic material in a cell. Mutagens are agents that permanently change genetic material, i.e., DNA, which may affect reproductive health. Mutagens are associated with GHS code H340, Germ Cell Mutagenicity.

Reproductive toxicants, teratogens, and germ cell mutagens correspond with the following Globally Harmonized System (GHS) codes and hazard statements as seen on Safety Data Sheets (SDS):

(Category 1A reproductive toxicants are known human reproductive toxicants largely based on human evidence.)

Lab workers with concerns regarding any chemical with these or other GHS codes should reach out to EHS for assistance.

• Radiation: For purposes of this document, laboratory workers can be exposed to ionizing and/or non-ionizing radiation.
• Non-ionizing radiation is the lower energy portion of the electromagnetic spectrum with wavelengths longer than 10nm. This includes: radio, microwave, infrared (IR), visible, ultraviolet (UV), lasers. High-energy magnets (i.e., NMR and MRI) also fall within this category.
• Ionizing radiation is the higher energy portion of the electrometric spectrum with wavelengths shorter than 10nm and has enough energy to remove electrons from atoms, including x-rays and radionuclides used in research (i.e., carbon-14, hydrogen-3, iodine-125, phosphorous-32, sulfur-35).

Ionizing radiation has the potential to cause acute and chronic biological effects. Laboratory workers using ionizing radiation should contact the Division of Medical Physics and Radiation Safety for additional information on safe handling and hazards. Laboratory workers may voluntarily declare a pregnancy to DMPRS and receive additional NRC Regulatory Guide 8.13 and 8.29 information.

Working with Reproductive Hazards

Standard laboratory hazard control measures (fume hood, proper PPE, etc.) are generally sufficient protection for routine work with reproductive hazards. However, additional voluntary control measures may be discussed if there are still concerns regarding pregnancy and/or fertility. It is recommended that ROHP be consulted if there are additional concerns when pregnant or attempting to become pregnant. Under these conditions, the individual should follow the guidance outlined in this document. At any point throughout the process detailed in the guidance below, the laboratory worker may decide they are comfortable with their work situation and should be permitted to continue typical work duties unless modifications are otherwise requested.

Routes of Exposure

The four major routes of hazardous chemical or biological exposure are inhalation, ingestion, injection, and absorption. In the laboratory, inhalation and accidental dermal absorption are the most expected routes of exposure which may be: acute and have an immediate impact where severe and/or dangerous adverse effects occur within a short period of time following exposure, or; chronic, which can have a cumulative, long-term effect on the worker’s health due to prolonged or repeated exposure, often at low levels.

Exposure Control and Prevention

The preferred method of exposure prevention is hazard elimination and/or substitution. When the hazard cannot be removed, exposure can be mitigated, in decreasing order of effectiveness, through engineering controls (i.e., chemical fume hoods or shielding), administrative controls (i.e., standard operating procedures (SOPS)), and lastly personal protective equipment (PPE) (i.e., resistant gloves, aprons).

Roles & Responsibilities

• Laboratory workers, i.e., all individuals who work in laboratories, including visiting scholars and students (graduate and undergraduate)–especially those who are pregnant or seeking to become pregnant
• • Seek to understand hazards of chemicals, biological agents, and the laboratory environment as communicated by the PI, EHS, and Safety Data Sheets (SDS);
  • Protect yourself from exposure by correctly using the recommended personal protective equipment (PPE) and engineering controls (i.e., chemical fume hood) and practice good lab and hand hygiene;
  • Follow the Laboratory Reproductive Hazard Identification Procedure, below, if seeking to make adjustments to chemical and/or biological handling procedures in the lab;
  • Contact ROHP if there are pregnancy and/or pregnancy-related condition concerns and requests for accommodations as they relate to work environment;
  • If a reasonable accommodation plan is developed, honor and follow the modifications to job activities.
  • Voice concerns about reproductive toxicants and communicate with EHS and ROHP as needed.

• Principal Investigator (PI), Research Core Director (RCD), Instructor/Lecturer, Lab Manager (henceforth referred to as PI)
  • Communicate hazards (chemical, biological, and/or radiological) to laboratory workers including reproductive hazards and inform lab workers of known reproductive hazards, as described in the Chemical Hygiene Plan (CHP) and by OSHA regulation;
  • As per the CHP, ensure that laboratory workers have access to adequate PPE and engineering controls;
  • Provide training programs and document that training has been completed on specific laboratory hazards;
  • Honor reasonable accommodation plans tailored to the specific needs and concerns of the individual and avoid making informal accommodations without following the Equal Opportunity Office’s (EOO) accommodation procedure;
  • Honor and maintain requests for confidentiality when a laboratory worker discloses pregnancy status.

• Other laboratory members
  • Honor any modified work arrangements as designated by the PI as part of this process;
  • Understand hazards of the laboratory;
  • Communicate concerns about reproductive health in the lab to PI, EHS, and/or ROHP;
  • Inform coworkers working in close proximity when using known reproductive toxicants.

• Research Occupational Health Program (ROHP)
  • Provide confidential reproductive counseling for laboratory workers;
  • Provide laboratory worker with information regarding Massachusetts Pregnant Worker’s Fairness Act (MA PWFA);
  • Request job hazard analysis (JHA)/risk assessment from Environmental Health and Safety (EHS) and/or Division of Medical Physics and Radiation Safety (DMPRS), as needed;
  • During medical consultation, provide guidance on laboratory specific biological and/or chemical hazards;
  • Provide immediate first aid care; post exposure risk assessment and guidance;
  • Provide medical surveillance for hazardous agents in compliance with relevant OSHA standards as indicated by EHS exposure assessment;
  • Coordinate medical care and additional follow-up management as needed;
  • Refer employee laboratory workers to Equal Opportunity Office (EOO) and student laboratory workers to Disability and Access Services (DAS) as needed.

• Environmental Health & Safety (EHS) including the Division of Medical Physics and Radiation Safety (DMPRS)
  • Provide guidance and recommendations to lab workers on safe lab practices;
  • Perform job hazard analyses (JHA)/risk assessments for reproductive hazards as requested;
  • When requested by ROHP, provide written report of JHA;
  • Investigate cases of suspected or reported exposure;
  • Complete exposure monitoring as requested and when practical and/or as required by code;
  • Provide informal training during reproductive toxicant job hazard analysis;
  • Refer lab workers to ROHP and EOO/DAS as needed.

• Equal Opportunity Office (EOO) – for BU employees
  • Engages employees in an interactive dialog to arrange reasonable accommodations for pregnancy or pregnancy-related conditions;
  • Refer lab workers to EHS and ROHP as needed;
  • Holds documentation of workers requests for reasonable accommodations separate from regular personnel file.

• Disability and Access Services (DAS) – for BU Students
  • Engages students in an interactive dialog to arrange reasonable accommodations for pregnancy or pregnancy-related conditions;
  • Refer lab workers to EHS and ROHP as needed;
  • Holds documentation of workers requests for reasonable accommodations separate from regular personnel file.

Laboratory Reproductive Hazard Risk Assessment Procedure

A laboratory worker may have concerns about a chemical, class of chemicals, and/or biological agent(s) that they work with before an anticipated pregnancy or while pregnant. It is recommended that the laboratory worker follow procedures outlined below to address these concerns and to receive additional support through ROHP and EHS if desired. At any point throughout the process, the laboratory worker may decide s/he is comfortable with his/her work situation and continue with normal work responsibilities.

1. Hazard Identification: Laboratory workers should first consult safety information and resources before proceeding.
   • Determine which potential reproductive hazards are present in the laboratory work environment – biological, chemical, and/or radiological
   • Biological- Independently review the pathogen safety data sheet for the agents on group’s IBC protocol. Additional information is also provided through ROHP on consultation and during medical clearances.
   • Chemical- Independently review the chemical safety data sheet (SDS).
     • Specific chemical reproductive toxicants of greatest concern include chemicals labeled with GHS codes H360D, H360FD, and/or Category 1A reproductive toxicants (see sections 2 and 11 of the SDS).
     • SDS are available through the chemical manufacturer, SciShield, the PI, or EHS.
     • Laboratory workers may also consult PubChem, Massachusetts Right to Know documents, the NIOSH Pocket Guide, and other resources that may be found in the References section of this guidance.
2. ROHP Consultation: Laboratory workers may request a meeting with ROHP, which serves as an opportunity to assess the available information with a medical professional, discuss risk, and receive information on MA PWFA.
   • Helpful information to provide at this ROHP meeting includes:
     • The laboratory’s chemical inventory and/or list of biological agents;
     • Safety Data Sheet (SDS) for the chemical(s) and/or pathogen safety data sheet of the biological agent (s) of concern before consultation visit;
     • Copy of laboratory’s experimental procedure (if applicable) before consultation visit.
   • To contact ROHP call (617) 358-7647 or email ROHP@bu.edu.
3. EHS (including DMPRS) Job Hazard Analysis: At ROHP’s and/or the laboratory worker’s request, EHS will perform a work area review and job hazard analysis (JHA). The laboratory worker does not need to disclose why they are requesting a JHA, though disclosing pregnancy/pregnancy related concerns will assist in the process.
   • This review will serve as a risk assessment where EHS assesses the workspace and worker’s exposure potential and provide any recommendations for exposure reduction.
     • EHS should ensure privacy of the employee is protected throughout the exposure assessment process unless laboratory worker pregnancy status is already known.
   • EHS will provide the laboratory worker and ROHP with a written report of the JHA including recommendations for PPE, engineering controls, and/or modified work practices as needed.
   • Contact EHS at 617-353-4094 or ehs@bu.edu for further information on chemical and/or biological safety.
4. Laboratory worker review of ROHP and EHS recommendation:
   • If job accommodations and/or process modifications are recommended, continue to step 5 if desired.
   • If job accommodations and/or process modifications are not recommended, stop. Laboratory worker continues with normal duties and may inform PI, if desired.
   • No further ROHP/EHS action required unless worker returns to ROHP/EHS due to change in circumstances
5. Laboratory worker referral to EOO/DAS: 
   • Employees – laboratory workers who are requesting reasonable accommodations are referred to Equal Opportunity Office and follow EOO’s normal accommodation process using the information and guidance gathered from EHS and ROHP.
   • Students (graduate and undergraduate) – laboratory workers who are requesting reasonable accommodations are referred to Disability and Access Services and follow DAS’s normal accommodation process using the information and guidance gathered from EHS and ROHP.
   • Note: that a laboratory worker is not required to consult with ROHP, EOO, and/or EHS prior to disclosing their pregnancy status to the PI.
6. Reasonable Accommodations Arrangement with PI: Share individualized reasonable accommodations with PI after consultation with EOO/DAS.
7. Return to Normal Duties: At the time specified in the reasonable accommodations agreement, and in as needed, further consultation with EHS, EOO, and/or ROHP, the laboratory worker will return to normal duties.

Note: 

This process, in whole or part, may be revisited as needed throughout the pregnancy and additional modifications made as needed.

Common Reproductive Hazards

• Chemical Reproductive Toxicants

  • Many laboratories at BU use reproductive or developmental toxicant chemicals; some examples of chemicals found at BU are provided in the tables below. Check SDS of each chemical to determine if it is a Reproductive Toxicant.

Table 1: Example Category 1 Chemicals: Known or presumed human reproductive toxicants

*Commonly used at BU

Table 2: Example Category 2 Chemicals: Suspected human reproductive toxicants

Biological Reproductive Hazardous Agents

See: https://www.cdc.gov/niosh/topics/repro/infectious.html

References

• https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200AppA
• OSHA Hazard Communication Standard (29 CFR. 1910.1200) Appendix A – Health Hazard Criteria formally defines reproductive toxins as substances which produces adverse effects on sexual function and fertility in adult males and females, as well as adverse effects on development of the offspring and classifies the toxins into one of two categories:
  • Category 1-Known or presumed human reproductive toxicant
  • Category 1A- Known human reproductive toxicant
  • Category 1B- Presumed human reproductive toxicant
  • Category 2-Suspected human reproductive toxicant
  • Chemicals that may interfere with lactation or which may be present in breast milk and may cause harm to breast-fed children are categorized separately as “Effects on or via Lactation” by OSHA.
• https://www.osha.gov/reproductive-hazards
• https://www.cdc.gov/niosh/topics/repro/infectious.html
• https://www.cdc.gov/niosh/topics/repro/employers.html
• https://www.cdc.gov/niosh/topics/repro/
• https://www.nrc.gov/docs/ML0037/ML003739438.pdf
• https://www.nrc.gov/docs/ML0037/ML003739505.pdf
• https://www.canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment.html
• https://www.schc.org/assets/docs/ghs_info_sheets/schc_osha_reproductive_toxicity_4-4-16.pdf
• https://pubs.acs.org/doi/10.1021/jacs.1c03725?fig=tbl3&ref=pdf
• https://www.bu.edu/eoo/reasonable-accommodations/