Transcript Fetal Protection Policies - American Industrial Hygiene Association

AIHA St. Louis Section
November 21,2013
Wes Norton CIH CSP
Relies on healthy properly functioning
maternal, paternal and fetal systems
 Disruption can result in a broad range of
negative effects including
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infertility
poor pregnancy outcomes
childhood illness including cancers
heritable alterations affecting future generations
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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.
* 2003
**2002
American College of Occupational and
Environmental Medicine
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.
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
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.
Prevalence of Reproductive Dysfunction
Endpoint
Infertility
Infertility
Impaired fecundity
Decreased sperm
concentration (<20
million/ml)
Amenorrhea or
oligomenorrhea
Premature ovarian
failure/premature
menopause
Observed Frequency
8,9
7-9% of married women
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2.4% of married men
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12% of women, 15% of married women
15% of non-smoking Danish men
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4.3% of Dutch 14-17-year-old women
1% of women
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Prevalence of Developmental Dysfunction
Endpoint
Spontaneous abortion — clinically recognized
All spontaneous abortions
Stillbirth — fetal loss after 20 weeks
Neonatal mortality (deaths of infants <28 days of age)
Perinatal mortality deaths of infants <7 days of age
Observed Frequency
5
10-15%
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15-50%
6.2 per 1,000 live births and
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fetal deaths
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4.6 per 1,000 live births
Low birth weight (defined as <2,500g)
Gestational age at delivery — prematurity
Chromosome abnormalities
Multiple births
Major birth defects identified at birth
Major birth defects identified during 1st year of life
6.7 per 1,000 live births and
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fetal deaths
6.8 deaths per 1,000 live
14,15
births
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8.2%
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12.7%
5 per 1,000 live births
3.3% of live births
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2-4%
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6-7%
Minor birth defects manifesting during 1st year of life
14%
Childhood leukemia
4 per 100,000 children under
20
age 20
2.5 per 100,000 children under
20
age 20
Infant mortality (death during first year after birth)
Childhood central nervous system malignancies
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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
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
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Father of Occupational
Medicine
17-18 Century
Midwives
Bloodborne diseases
• Skin disease from syphyllis
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Miners
• Lead Intoxication
• Heavy metal poisoning
Nuns
• Breast cancer due to unnatural
lack of sexual activity
On Monsters and Marvels 1573
1) the glory of God
2)his wrath
3) too greatly a quantity of seed
4) too little a quantity
5) the imagination
6) the narrowness / smallness of the womb
7) the indecent posture of the mother
8) fall or blows to the womb
9) hereditary or accidental illness
10)rotten or corrupt seed
11) mixture or mingling of seed
12) Artifice of wicked beggars
13) through demons and devils
Ambroise Pare
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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 and
the fear of the mother, who had
witnessed the events
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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
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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 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
An infant with birth abnormalities from
thalidomide
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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
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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
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Number of women in the workplace increased
from 30 million in 1970 to more than 67
million in 2007
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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
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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)
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Forbids sex discrimination in employment
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“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.”
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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.”
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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.
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.
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Avoid or significantly modify FPP
Rely on improving overall conditions in work
environment
Substitute identified substances where feasible ex.
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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.
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.
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"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. “
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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
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Section 5 Cause developmental toxicity, male
reproductive toxicity and female 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”
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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
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Concerns about worker difficulty understanding
MSDS’s
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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.
Category 1
Known/Presumed
Known to produce heritable mutations in
human germ cells
Subcategory 1A
Positive evidence
from
epidemiological
studies
Category 2
Suspected/Possible
•May include heritable
mutations in human germ
cells
•Positive evidence from
Subcategory 1B
•Positive results in: In vivo tests in mammals and
heritable germ cell tests in somatic cell tests
•In vivo somatic
mammals
genotoxicity supported by
•Human germ cell tests
in vitro mutagenicity
•In vivo somatic
mutagenicity tests,
combined with some
evidence of 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
Category 1
Category 2
Suspected
Additional
Category
Known or presumed to cause
Human or animal Effects on or via
effects on human reproduction or evidence
lactation
on development
possibly with
other
information
Category 1A
Category 1B
Known
Based on human Presumed
evidence
Based on
experimental
animals
OSHA • NIOSH
OSHA Recognizes Reproductive Hazards
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Has standards specific to chemicals such as lead; 1, 2-Dibromo3 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
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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
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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
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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
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
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.
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/afi48145/afi48-145.pdf
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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
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Review and Evaluate Work Practices, Materials, Equipment,
Areas and Control Measures
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Identify Work Elements with Potential Risk
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Discuss Additional Precautionary Actions for Protection
of Fetus
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ID materials with known or suspected toxicity
Evaluate Exposure Potential and Controls
Quantify exposure level
Helpful References
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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
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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
Guidelines for Lifting in Pregnancy American Journal of
Obstetrics and Gynecology
Possible 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
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From NIOSH Last updated 9/20/2013
For specific inquiries:
CDC Info: [email protected] , 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.d03
t03
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/abstract
Sathyanarayana 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).
Additional links on speaker notes below