AIHA St. Louis SectionNovember 21,2013

Wes Norton CIH CSP

Occupational Reproductive Health and Fetal Protection Policies for the 21st Century

Relies on healthy properly functioning maternal, paternal and fetal systems

Disruption can result in a broad range of negative effects including◦ infertility◦ poor pregnancy outcomes◦ childhood illness including cancers◦ heritable alterations affecting future generations

Reproductive Success

Increasing Knowledge of Risks Demographic changes• 65% Employed Reproductive Age*• 55% children born to working Mothers**• Trend increasing with Baby Boomer Retirements Changes in Hazard Communication - GHS Worker's perception of risk can quickly change when

directly involved in exposure to a hazardous chemical or condition.

Occupational Reproductive Health and Fetal Protection Require Priority Attention of Health and Safety Professionals

* 2003**2002

Reproductive Hazards Management Guidelines Adopted April 2011 Encourages persons responsible for workplace health and safety to:

• Assess their workplaces for potential reproductive hazards

• Implement practices including: communication about potential risks and hazards, temporary reassignment, hazard elimination, and exposure control.

American College of Occupational and Environmental Medicine

Reproductive Toxicity

Adverse effects on the reproductive system that may result from exposure to toxins or environmental agents.

Includes alterations to the reproductive organs and/or the related endocrine system

Developmental Toxicity

Adverse effects on the developing organism that may result from exposure before conception (either parent), during prenatal development, or post-natal to the time of sexual maturation

Includes fetal death, structural abnormalities or birth defects, functional deficiencies, or altered growth

http://www.acoem.org/aboutACOEM.aspx#sthash.pnaJklvh.dpuf

ACOEM Guidelines Scope

Occupational / Environmental Exposure to chemicals, pesticides, radiation, biological hazards, heavy workload, heat, awkward / sedentary postures, irregular work schedules, psychosocial stress, nutrition, lifestyle, drugs

Competing priorities – Legal, Economic

Unknowns including- 84,000 chemical compounds are in the workplace, with 2,000 new chemicals introduced each year. Only about 4,000 of these chemicals have been evaluated for reproductive toxicity.

The Challenge can be Overwhelming

Prevalence of Reproductive Dysfunction 

Endpoint   Observed Frequency 

Infertility 7-9% of married women8,9  Infertility 2.4% of married men10  

Impaired fecundity 12% of women, 15% of married women9 

Decreased sperm concentration (<20

million/ml)

15% of non-smoking Danish men11  

Amenorrhea or oligomenorrhea

4.3% of Dutch 14-17-year-old women12  

Premature ovarian failure/premature

menopause

1% of women13  

Prevalence of Developmental Dysfunction

Endpoint  Observed Frequency Spontaneous abortion — clinically recognized   10-15%5  All spontaneous abortions 15-50%5 Stillbirth — fetal loss after 20 weeks   6.2 per 1,000 live births and

fetal deaths14  Neonatal mortality (deaths of infants <28 days of age)  

4.6 per 1,000 live births14  

Perinatal mortality deaths of infants <7 days of age 6.7 per 1,000 live births and fetal deaths14  

Infant mortality (death during first year after birth)   6.8 deaths per 1,000 live births14,15  

Low birth weight (defined as <2,500g)   8.2%16  Gestational age at delivery — prematurity 12.7%16  Chromosome abnormalities   5 per 1,000 live birthsMultiple births   3.3% of live births Major birth defects identified at birth   2-4%18,19  Major birth defects identified during 1st year of life   6-7%19  

Minor birth defects manifesting during 1st year of life 14%19  

Childhood leukemia 4 per 100,000 children under age 2020  

Childhood central nervous system malignancies 2.5 per 100,000 children under age 2020  

The Progression of our Understanding of Reproductive and Fetal Health

Changes in Workforce, Laws and Regulations Hazard Recognition and Communications Action Plan for and Health and Safety

Professionals and Employers Resources to help reduce risk from

Reproductive and Developmental Hazards and promote health

Overview

Set the Wayback Machine to 4 BC Sherman !

Euripides Father is like a plough and the mother a field Father transmits the genetic material into

something like an incubator.

Aristotle “Replacement Theory” Creatures evolve, change is more than

accidental Matter is provided by the mother Fathers’ semen contains the‘Guiding Principle’ producing form

Our Evolving Understanding of Reproductive Health

Midwives• Bloodborne diseases• Skin disease from syphyllis

Miners• Lead Intoxication• Heavy metal poisoning

Nuns • Breast cancer due to unnatural lack of sexual activity

Father of Occupational Medicine 17-18 Century

On Monsters and Marvels 15731) the glory of God2)his wrath3) too greatly a quantity of seed4) too little a quantity5) the imagination6) the narrowness / smallness of the womb7) the indecent posture of the mother8) fall or blows to the womb9) hereditary or accidental illness10)rotten or corrupt seed11) mixture or mingling of seed12) Artifice of wicked beggars13) through demons and devils Ambroise Pare

13

Ancient and medieval theories remained popular

This man was nicknamed “Lionel the Lion-man” by Barnum and Bailey Circus  

As late at 1901 abnormalities were explained as the result of his father being killed by a lion andthe fear of the mother, who had witnessed the events

14

Precipitous decline in infant mortality in the US Economic growth Improved nutrition New sanitary measures Advances in knowledge about infant care Cleaning market milk supply

Late 19th and early 20th Century

From CDC October 1999

Josef Warkany – Father of Teratology 1940 dietary deficiencies in pregnancy can

cause abnormalities in offspring 1948 Linked Mercury poisoning to Acrodynia 1960 Founded the Teratology Society

“ the fetus should be assured so far as possible by the protection of the expectant mother from adverse environmental influences”

Thalidomide

An infant with birth abnormalities from thalidomide

18

•Thalidomide  was meant as a sleeping aid but prescribed to pregnant women to treat anxiety and nausea• 1960’s Caused serious birth abnormalities in thousands of children•Mothers of thalidomide babies felt responsible for the conditions of their children•Thalidomide led to stricter tests to determine a drug’s impact on a fetus

Effects of Consumption on pregnancy outcomes observed throughout history

Formal description and clinical diagnosis of effects was not introduced until 1973.

Leading preventable cause of birth defects and developmental disorders in the US

Estimated to occur in more than1 percent of births

Fetal Alcohol Spectrum Disorders

Women in the Workplace 20th Century & Beyond 1918 3 million 1918 nearly 3 million new women

workers were employed in food, textile and war industries.

WW 2 Women in Industrial Jobs

◦ 310,000 US aircraft industry (from 1 to 65%)◦ By 1945 One of 4 married women worked outside the

home

Number of women in the workplace increased from 30 million in 1970 to more than 67 million in 2007

Policies that attempt to protect the fetus from workplace hazards by excluding fertile women from certain jobs

Common in the United States in the 1970s and 1980s Became controversial because women were being

excluded from certain jobs (including promotional opportunities and better wages/benefits) on the basis that they could become pregnant, even if they had no intention of doing so

Men were not included in the policies even when their reproductive health could also be impacted by exposure

Fetal Protection Policies

1982, battery manufacturer Johnson Controls implements a fetal protection policy preventing women capable of bearing children from holding jobs with lead exposure

Class action lawsuit raised against Johnson Controls by women alleging lost jobs or transfers to lower paying jobs as a result of the policy

1991, U.S. Supreme Court ruled that Johnson Controls' fetal protection policy discriminated against women in violation of Title VII of the 1964 Civil Rights Act as amended by the Pregnancy Discrimination Act (PDA)

Automobile Workers v. Johnson Controls (1991)

Forbids sex discrimination in employment

“It shall be an unlawful employment practice for an employer◦ (1) to fail or refuse to hire or to discharge any individual, or

otherwise to discriminate against any individual with respect to his compensation, terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin; or

◦ (2) to limit, segregate, or classify his employees or applicants for employment in any way which would deprive or tend to deprive any individual of employment opportunities or otherwise adversely affect his status as an employee, because of such individual’s race, color, religion, sex, or national origin.”

Title VII of the Civil RightsAct of 1964

Amends Title VII of the Civil Rights Act of 1964 to prohibit sex discrimination on the basis of pregnancy

◦ “The terms 'because of sex' or 'on the basis of sex' include, but are not limited to, because of or on the basis of pregnancy, childbirth, or related medical conditions; and women affected by pregnancy, childbirth, or related medical conditions shall be treated the same for all employment-related purposes, including receipt of benefits under fringe benefit programs, as other persons not so affected but similar in their ability or inability to work, and nothing in section 703(h) of this title shall be interpreted to permit otherwise.”

PregnancyDiscrimination Act of 1978

Implications of the U.S. Supreme Court ruling: ◦ Employers can’t deny fertile women a choice given to

fertile men as to whether they wish to risk their reproductive health for a particular job.

◦ An employer can't determine if a work environment is too hazardous for a pregnant worker and change her work status solely on the basis of her pregnancy. The pregnant employee and her physician are charged with making such a decision.

◦ Fetal protection policies are not legal even if the employer can prove that a substance to which its workers are exposed will endanger the health of a fetus. If a company complies with health and safety regulations and fully informs the woman of the risk, then the employer has not been negligent.

Automobile Workers v. Johnson Controls (1991)

Employers, concerned with both fetal health and the specter of massive tort liability for injured third parties.

Caught in a legal crossfire: Do nothing about these issues and be sued

by injured parties Utilize a FPP and be sued by workers denied

their equal employment rights.

Fetal Protection Policy Shift

Avoid or significantly modify FPP Rely on improving overall conditions in work

environment Substitute identified substances where feasible

ex. Lead Ethylene Glycol Monomethyl ether & acetate Ethylene Glycol Monoethyl ether & acetate

Hazard Communication both genders Provide MSDS’s and PPE to Pregnant workers for

review with OB, and allow work restrictions as requested.

Our Experience

1996 NIOSH formed a National Occupational Research Agenda (NORA) including RHRT to:

Promote communication and partnering among reproductive toxicologists, clinicians and epidemiologists

Improve reproductive hazard exposure assessment and management

Encourage needed research.

NORA Reproductive Health Research Team (RHRT)

"While more than 1,000 workplace chemicals have shown reproductive effects in animals, most have not been studied in humans. In addition, most of the 4 million other chemical mixtures in commercial use remain untested. Physical and biological agents in the workplace that may affect fertility and pregnancy outcomes are practically unstudied. The inadequacy of current knowledge coupled with the ever-growing variety of workplace exposures pose a potentially serious public health problem. “

Preamble to NORA RHRT – Statement on Reproductive Hazards

RHRT Team Established a National Occupational Reproductive Health Research Agenda

Prioritized reproductive toxicants for further Research and helped coordinate the studies Promoted occupational exposure assessment in

surveillance studies Partnership with the NTP Center for the Evaluation of

Risks to Human Reproduction (CERHR) Collaborating with CDC National Center on Birth Defects

and Developmental Disabilities and National Cancer Institute to conduct occupational exposure assessments

Supported Improved Hazard Communications

NORA 10 years Team Document http://www.cdc.gov/niosh/docs/2006-121/pdfs/2006-121.pdf

Updated Criteria Document December 18, 2012

http://www.cdc.gov/niosh/docs/2013-128/pdfs/2013_128.pdf

Section 5 Cause developmental toxicity, male reproductive toxicity and female reproductive toxicity

NIOSH on Cr+6 Developmental and Reproductive Toxicity

In 2005 SOT Reports Problems with MSDS’s“The message that reproductive health includes both men and

women, and that it can be affected by their workplace exposures, needs to reach the workers and their employers through MSDS communication”

Study of MSDS’s Massachusetts Lead and Glycol Ethers◦ 60% did not mention possible reproductive health effects◦ Where reproductive effects are mentioned, 18X more

likely to be developmental effects than male reproductive risk

Concerns about worker difficulty understanding MSDS’s

Hazard Communications

Will GHS Starman be a Superhero ?

Mutagen means an agent giving rise to an increased occurrence of mutations in populations of cells and/or organisms.

Substances and mixtures in this hazard class are assigned to one of two hazard categories.

3.2.6 Germ Cell Mutagenicity

Category 1Known/Presumed

Category 2Suspected/Possible

Known to produce heritable mutations in human germ cells

•May include heritable mutations in human germ cells•Positive evidence from tests in mammals and somatic cell tests•In vivo somatic genotoxicity supported by in vitro mutagenicity

Subcategory 1APositive evidence from epidemiological studies

Subcategory 1B•Positive results in: In vivo heritable germ cell tests in mammals•Human germ cell tests•In vivo somatic mutagenicity tests, combined with some evidence of germ cell mutagenicity

Table 3.11 Germ Cell Mutagenicity

Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in offspring.  

Substances and mixtures with reproductive and/or developmental effects are assigned to one of two hazard categories

3.2.8 Reproductive Toxicity

Category 1 

Category 2Suspected

AdditionalCategory

Known or presumed to cause effects on human reproduction or on development

Human or animal evidence possibly with other information

Effects on or via lactation

Category 1AKnown

Based on human

evidence

Category 1B

PresumedBased on experimental animals

Reproductive Toxicity

OSHA • NIOSH

OSHA Recognizes Reproductive Hazards Has standards specific to chemicals such as lead; 1, 2-

Dibromo-3 Chloropropane; and ethylene oxide that are known to have an adverse effect on reproductive system

Identifies Biological, Chemical and Physical Agents with reproductive risk in OSHA Technical Manual

Recognize developing fetus may be adversely affected at lower doses than established exposure limits

Maintain Authority to Cite using General Duty Clause Made Changes to Hacom Standard to align with GHS – most

provisions effective by 2015

Hazard Communication – GHS

Regulation 16 of the Management of Health and Safety at Work Regulations 1999 places a duty on employers to carry out a risk assessment for new or expectant mothers

http://www.hse.gov.uk/contact/faqs/pregnancy.htm

Fetal Protection - UK

Review Current Reproductive and Developmental Health Program /Policy ◦ Update as appropriate◦ Re-enforce Sr. Management Awareness and Support ◦ Ensure Key Elements are Incorporated in Safety Management

System Survey Operations to Identify Physical and biological agents

in the workplace that may affect fertility and pregnancy outcomes

Embrace GHS as an opportunity to◦ Reassess recognition of Chemical Toxicants◦ Ensure hazard communications are effective and understood

Action Plan for Health and Safety Professionals and Employers

Suggested Key Elements Overview and Scope Assign and Define Responsibilities

◦ Employee◦ Employer

Establish Hazard Assessment Procedure Pre and Post Conception Reproductive and Developmental

Health Training and Counseling - Occupational and Non Occupational

Precautions to prevent ‘take home’ family exposures Resources and References Program Evaluation and Review Process

Verify Employer Reproductive and Developmental Health Program /Policy

REPRODUCTIVE HEALTH PROTECTION PROGRAM Summary This program provides assistance to staff, and supervisors when dealing with questions related to reproductive health and

work at the University. These guidelines provide the necessary information and direction to assist the concerned persons and their supervisors so that options are understood and and informed decision can be made by the employee. These guidelines are developed to provide additional protection for the fetus, and to establish specific procedures to protect pregnant employees. Control of employee exposures will be carried out 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 reproductive hazards requires full cooperation with these procedures as soon as pregnancy is contemplated or determined to implement these guidelines.

Background Through the course of work at NC State University, employees may work with agents which are known or suspect to be

hazardous to human reproduction. These agents include radiation, chemicals, biological agents, and physical hazards, as well as many other factors (standing, climbing, heat/cold exposure, medications, etc). Since risk factors are encountered both in work and at home, a review by the concerned employee’s personal physician is recommended so that a complete picture can be obtained. Consultation is also available through the Environmental Health and Safety Center and NC consulting physicians associated with the University occupational medicine program.

Definitions When one considers reproductive risk, both reproductive toxicity and developmental toxicity should be considered. Reproductive Toxicity – Adverse effect on the health of the reproductive organs, endocrine system, or

gametes (egg or sperm) from exposure to an exogenous agent. May result in effects such as mentstrual dysfunction, impaired fertility, feminization, masculinization, or inability to maintain a pregnancy.

Developmental Toxicity – Adverse effects on the developing organism that may occur anytime from conception to sexual maturity. Effects may include spontaneous abortion, structural or functional defects, low birth weight, or effects that may appear later in life.

Persons, both male and female, who are sexually active, planning a pregnancy, or pregnant should recognize the need for safe work practices at all times, since certain reproductive effects occur at very early stages of pregnancy, perhaps prior to recognition by females that they are pregnant.

Objective To educate staff on the risks to reproductive health associated with work related activities and the need for safe work

practices on a continual basis. To provide procedures for assessing workplace condition, obtaining medical input, and assessing options for managing

work and reproductive risk.

Example Program – North Carolina State University

AIR FORCE INSTRUCTION 48-145 Aerospace Medicine OCCUPATIONAL AND ENVIRONMENTAL HEALTH PROGRAM

Responsibilities for Mandatory Program Elements 2.12. Public Health Flight Commander (or local equivalent).

2.12.3. Manages the Installation Fetal Protection Program 2.12.3.1. Interviews all pregnant female workers (military and civilian)

assigned to the base (upon notification of pregnancy by worker, supervisor, laboratory, or military health care provider (HCP)).

2.12.3.2. Consults with BE, the military HCP managing the pregnancy, and the IOEMC on potential OEH threats, records health risks, documents and distributes recommended preventive actions on the AF Form 469, Duty Limiting Condition Report IAW AFI 44-102, Medical Care Management and AFI 10-203, Duty Limiting Conditions.

2.13. Installation Occupational and Environmental Medicine Consultant (IOEMC).

2.13.5. Reviews all pregnancy AF Form 469s (military members) and other pregnancy-related correspondence (for federal civilian employees) to ensure that recommendations made adequately protect the worker and fetus from work place exposures and that work restrictions, based on medical condition and exposure, are consistently applied. Specific guidance is outlined in AFI 10-203 and AFI 44-102.

http://static.e-publishing.af.mil/production/1/af_ja/publication/afi48-145/afi48-145.pdf

Recommend Pre and Post conception review Confidential at employee’s request May include supervisor General discussion

◦ Occupational and Non Occupational Hazards

◦ Preventative Measures and Precautions

Review and Evaluate Work Practices, Materials, Equipment, Areas and Control Measures

Identify Work Elements with Potential Risk Discuss Additional Precautionary Actions for Protection

of Fetus

Reproductive Health Consultation and Fetal Protection Review

Review Materials for Potential Reproductive and Developmental Toxicity ID materials with known or suspected toxicity Evaluate Exposure Potential and Controls Quantify exposure level

Helpful References California Office of Environmental Health Hazard Assessment

(OEHHA) “Proposition 65” list National Toxicology Program Center for Evaluation of Risks to

Human Reproduction Organization of Teratology Information Specialists New Jersey Chemical Substance Fact Sheets NIOSH Criteria Documents

Comprehensive reference to help identify materials that can pose a risk to the fetus

Does not conclusively establish the risk or exposure level for an adverse health effect

Criteria for Substance Listing◦ Known or having the potential to cause cancer

and/or reproductive toxicity◦ Federal regulatory agency requires a

reproductive toxicity warning label◦ Authoritative organization such as National

Toxicology Program concludes sufficient evidence of toxicity in animals or humans

http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html

California OEHSS

Other ResourcesGuidelines for Lifting in Pregnancy American Journal of

Obstetrics and GynecologyPossible health effects to unborn babies from exposure to

radiation Centers for Disease Control and Prevention (CDC).

Health Physics Society “ask the experts”http://hps.org/publicinformation/ate/

Introduction  On September 7, 2012 XXX, LLC at the request of XXX provided reproductive health consultation and performed a

fetal protection review of work tasks associated with a laboratory researcher’s assigned responsibilities at their XXX, MO site. The purpose of the visit was to make available and review selected reproductive health references and review and examine materials, equipment and work practices with a researcher currently in her first trimester of pregnancy.

 Job description  The employee interviewed is a Researcher in the XXX Department assigned to tasks performed for quality

assurance and method development. Work is performed in Labs XXX, XXX, XXX, Prep Area and the Sample Login Room. Work tasks include grinding dry product and raw material, weighing and transferring dry chemical materials, and transferring and handling liquid chemical materials and prepared mixed solutions. An ultrasonic sonicator located on a bench top approximately 6 feet from her work station is infrequently used for sample preparation. She is scheduled to begin a new method development assignment soon that includes grinding and performing lab procedures with raw chicken and swine flesh, fat and organs. Material lifting of up to 25 pounds is common. Work involves approximately 50% of time spent sitting at computer and Video Display Terminal (VDT).

  Controls  Safe operating procedures for identified chemical materials require transfer and handling inside laboratory hoods,

however many of the chemical materials used are handled on laboratory bench tops. Lab grade latex or nitrile gloves and safety glasses or goggles are used for all laboratory tasks. A filtering face piece dust respirator is used when grinding dry materials. Installation of an enclosure equipped with local exhaust ventilation is being evaluated in the Prep Area where dry material grinding is. Raw animal tissue grinding is performed in a ventilated lab hood labeled with biohazard warning signs. The spill response plan limits the cleanup by the researcher to small quantity releases. In the case of a large spill, the lab is evacuated and Emergency Response Team mobilized.

 Reproductive Health Consultation  NIOSH Publication 99-104 “The Effects of Workplace Hazards on Female Reproductive Health” was used to guide a

general discussion of related workplace hazards, preventative measures and precautions. A copy of the document was provided to the lab researcher. Research and guidance documents from OSHA, EPA, National

Example Report

From NIOSH Last updated 9/20/2013For specific inquiries: CDC Info: cdcinfo@cdc.gov , phone 800-CDC-INFO (800-232-4636)8AM-8PM ET, Monday-Friday, Closed Holidays. Provides answers to specific questions about occupational reproductive hazards, reproductive health, many other health topics.  New Jersey Right to Know Hazardous Substance Fact Sheets: http://web.doh.state.nj.us/rtkhsfs/indexfs.aspx. Well written workplace safety and health information, including reproductive health, for over 1600 workplace chemicals (many also

in Spanish). Produced by the New Jersey Department of Health in accordance with of the state Right-to-Know law to protect worker health.

 General information on occupational and environmental reproductive health: Occupational Exposures and Reproductive Health: Summary of the 2003 Teratology Society Meeting Symposium.

http://onlinelibrary.wiley.com/doi/10.1002/bdrb.20039/abstract;jsessionid=2920B45F20E35A449906AEBA62277469.d03t03 Grajewski B, Coble J, Frazier L, McDiarmid M. Birth Defects Res B Dev Reprod Toxicol 2005;74:157-163. Review article on occupational reproductive health, including a checklist to evaluate hazards and discussions of clinical strategies Environmental exposures: how to counsel preconception and prenatal patients in the clinical setting:

http://www.ajog.org/article/S0002-9378(12)00151-2/abstractSathyanarayana S, Focareta J, Dailey T, Buchanan S. American Journal of Obstetrics and Gynecology [E-pub ahead of print]. Review article discussing strategies for health care providers to counsel patients on known environmental risks to reproduction. Preventing Infection During Pregnancy: http://www.cdc.gov/Features/Pregnancy/General guidelines for preventing infection during pregnancy (intended for the general public, with PDFs in both English and

Spanish).

Links to Resources and References

Additional links on speaker notes below