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EXPERIMENTAL LABORATORY INVESTIGATIONS: Projects to elucidate
the biochemical and physiological mechanisms of activity and
nature of reproductive hazards in the workplace. Examples
include:

fo} Studies to develop and validate screening systems based
upon biochemical, enzymatic, or hormonal components of
body fluids (e.g., blood, urine, semen) that can be used
as reliable indices of the functional state of the
reproductive system.

fo} Investigations to develop, improve, or validate short-term
or in vitro methods for teratogenesis testing.

° Studies of mechanisms of teratogenesis, with the goal to
improve the ability to predict relative teratogenic
potential of chemically related compounds or to make
inter-species extrapolations of teratogenesis data.

° Research on the mechanisms by which abnormalities are
induced in sperm head morphology and the implications of
morphological changes as indicators of induced mutations
or of impaired reproductive capacity

CONTROL TECHNOLOGY: Projects to develop new and improved
methods or equipment to prevent reproductive effects from
occupational hazards

° Studies which identify workers potentially or actually
exposed to reproductive hazards and design new or improved
controls for the hazards.

° Research which adapts existing methods, as well as develop
new methods of monitoring and controlling reproductive
hazards in the workplace.

° Research which seeks to use innovative approaches, such as
alternative materials, engineering controls, process
modification and protective equipment to prevent known or
suspected reproductive problems.

HEALTH EDUCATION RESEARCH AND DEMONSTRATION PROJECTS: Projects
to increase awareness of the importance or reproductive hazards
in the workplace. Examples include :

° Development of educational programs for health
professionals, and worker educators to increase their
awareness of the issues and problems surrounding
reproductive effects from occupational hazards.


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A brief covering letter must accompany the application indicating that
it is submitted in response to this program announcement. A carbon copy
of this covering letter along with an additional copy of the application
should be sent to the Chief, Grants Administration and Review Branch
(see below).

IDENTIFICATION OF CONTACT POINT
Questions related to this announcement should be addressed to:

Faye Calhoun

Chief, Grants Administration and Review

Branch, National Institute for Occupational
Safety and Health

Parklawn Bldg., Room 8-63

5600 Fishers Lane

Rockville, Maryland 20857

Telephone: (301) 443-4493

or

Mr. Joseph West

Grants Management Officer, NIOSH
Parklawn Bldg., Room 8-29

5600 Fishers Lane

Rockville, Maryland 20857
Telephone: (301) 443-3122


8)

EPIDEMIOLOGY AND BIOMETRY: Projects which consider the
epidemiology of reproductive effects, including altered
fertility, spontaneous abortion, fetal deaths, genetic diseases
and disorders and childhood cancer, resulting from chemical and
physical occupational hazards. Of particular interest are
studies where dose-effect relationships are identified or
determined. NIOSH is interested in epidemiological research
using a variety of methods or approaches. Such methods include
those which generate hypotheses and typically use registries,
medical records or statistics as the primary data source and
those methods which tend to confirm hypotheses by demonstrating
dose-effect relationship or the prevention of an effect by
interruption of exposure. Specific examples of epidemiology
studies include:

° Studies which identify groups of workers with abnormal
reproductive experience and determine probable cause.

° Studies to determine whether an incidence of infertility,
spontaneous abortion, or fetal mortality in the
reproductive experience of a specific group of workers
and/or spouses is abnormal.

fo} Studies to assess the parental employment relatedness of
cancer in childhood.

fo} Studies on known reproductive hazards to evaluate and
compare methodologies and to determine association between
endpoints of the methodologies.

TOXICOLOGY: Projects to identify reproductive (mutagenic,
teratogenic, etc.) hazards of chemicals to workers and to
provide an early warning of the possible deleterious effects.
Specific examples include:

° Research which develops test systems to detect mutagenic
activity of air particulates, chemical mixtures or
complexes found in the workplace.

° Projects which study the possible synergistic effect of
mutagenic and teratogenic chemicals produced in

workplaces.
° Research to validate human cell mutagenic assay systems.
° Studies which evaluate the usefulness of body fluid

analysis and cytogenic assay systems for the assessment of
the mutagenic hazard of chemicals to workers.


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MECHANISM OF SUPPORT

The traditional grant-in-aid mechanism will be used to support grants
pursuant to this Program Announcement.

Nonprofit organizations and institutions, State and local governments
and their agencies, are eligible to apply.

Grants may be supported for up to three years, and may be renewed for an
additional period, subject to the competitive review procedure and
availability of funds.

Awards will be made based on priority score ranking, as well as
availability of funds for this Program.

Grantees will be required to cost share a minimum of five percent.

Grants will be made under the legislative authorization in Section
20(a)(1) of the Occupational Safety and Health Act of 1970 (29 USC 669
(a) (1), Public Law 91-596. The Catalogue of Federal Domestic Assistance
Citation is Section 13.262.

REVIEW PROCEDURES AND CRITERIA

The initial review of applications responsive to this Program
Announcement will be arranged by the Division of Research Grants. Major
factors considered in evaluating each application include:

° training, experience, and research competence, or promise, of
the applicant(s) to carry out the proposed investigations, and
the adequacy of effort (time) to be devoted to the project

fo} the scientific merit of the proposal: the questions proposed
for study, the research design, the proposed methodology, the
proposed methods for analysis and interpretation of data

fo} adequacy and suitability of the existing and proposed
facilities and resources.

° appropriateness of the requested budget relative to the work
proposed.

° adequacy of collaborative arrangement(s), if applicable.


DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
CENTER FOR DISEASE CONTROL
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH
ROBERT A. TAFT LABORATORIES
4676 COLUMBIA PARKWAY, CINCINNATI, OHIO 45226

OFFICIAL BUSINESS
PENALTY FOR PRIVATE USE. $300

First Class Mail

POSTAGE AND FEES PAID
U.S. DEPARTMENT OF HHS
HHS 396

DHHS (NIOSH) Publication No. 80-127


ATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

REPRODUCTIVE
EFFECTS
DUE TO
VVORKPLACE
HAZARDS

RESEARCH GRANT PROGRAM ANNOUNCEMENT

ea

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE

CENTER FOR DISEASE CONTROL

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A secondary review process will be conducted by NIOSH. Factors
considered in this review include:

° the results of the initial review;

° the significance of the proposed research to the research
program of NIOSH.

° national needs and program balance, and
° policy and budgetary considerations.

Applications responsive to this Program Announcement are not subject to
OMB Circular A-95 Clearinghouse and/or Health Systems Agency review.

Proposals considered to be non-responsive to the terms outlined in this
Program Announcement will be appropriately reassigned for review or
returned to the investigator, as indicated. Returned proposals may be
revised and resubmitted.

METHOD OF APPLYING

Applications should be submitted on a form PHS 398 (State and local
governments use form PHS 5161-1). Application kits may be obtained from:

Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 448
Bethesda, Maryland 20205
Telephone: (301) 496-7441

Care should be taken in following the instructions included with the
application form making certain to fulfill the points identified under
the heading "REVIEW CRITERIA."

An original and six copies (original and two copies for State and local
governments) must be received no later than: November 1, March 1, and
July 1 as applicable. Applications received after the designated
deadline will be considered with the applications received for the
following deadline. Completed applications must be sent or delivered to:

Application Receipt

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20205


June 30, 1980
PROGRAM ANNOUNCEMENT

GRANTS ADMINISTRATION AND REVIEW BRANCH
OFFICE OF EXTRAMURAL COORDINATION AND SPECIAL PROJECTS
NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH,
CENTER FOR DISEASE CONTROL

TITLE: REPRODUCTIVE EFFECTS FROM OCCUPATIONAL HAZARDS

Application receipt dates: November 1, March 1, and July 1

Altered fertility, low birth weight, spontaneous abortion,
transplacental carcinogenesis, congenital malformation, mutagenesis, and
developmental abnormalities are among the effects on reproduction that
have been recognized to result from toxic occupational exposure.
Exposure of both men and women can produce these effects. The knowledge
base in the area of toxic reproductive hazards is relatively small. The
National Institute for Occupational Safety and Health (NIOSH) would like
to expand its involvement in the identification and prevention of
reproductive effects from occupational hazards. The scope of this
announcement is flexible to encourage various interactive combinations
of research approaches that might yield insight into the issues and
problems surrounding reproductive effects as a consequence of physical
and chemical occupational hazards. The Institute is seeking
applications for research and demonstration grants concerned with basic
and applied projects in areas such as epidemiology, toxicology, control
technology, and health education.

I. BACKGROUND INFORMATION

The current responsibilities of NIOSH were established by the Public
Health Service Act, the Occupational Safety and Health Act of 1970 and
the Federal Mine Safety and Health Amendments Act of 1977. A major
NIOSH responsibility under those Acts is to conduct research necessary
to ensure, insofar as possible, that no worker will suffer diminished
health, reduced functional capacity, or decreased life expectancy as a
result of his or her work experience. As a part of this responsibility
NIOSH is concerned with discovering the identity and, if possible, the
prevalence of physical and chemical hazards to which male and female
workers who are exposed that might affect the development of their
unborn children. While a relatively few chemical and physical agents
are generally accepted as proven mutagens, teratogens, or carcinogens in
humans, over a thousand agents are reported to have these effects in
animals. Furthermore, many of these agents are reported to be mutagenic


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in biologic test systems and thus must be suspected as capable of
causing reproductive effects in humans.

Over the past several decades there has been a threefold increase in the
number of women employed in the U.S. workforce. During this period
women have been employed in more hazardous occupations including those
traditionally restricted to men. In recent years an increasing number
of pregnant women have remained on the job until near the end of
pregnancy. Thus, many more women and their unborn children are being
exposed to chemical, physical, and psychological hazards of the
workplace. Despite this fact, very little is known about the impact of
such exposures on fetal wastage and growth and development.

Because of the unique role of women in the reproductive process,
exposure to chemical and physical hazards has targetted attention on the
risks to the offspring of maternal exposure. In so doing, we tend to
forget that the working male exposed to mutagenic agents also places the
health of his offspring at risk.

Other areas of concern are:

(1.) Recognition of the potential that exists for harm to the germ cells
of parents of both sexes signals a need to investigate the possibility
that occupational hazards might affect the fertility of both men and
women ;

(2.) The realization that significant quantities of industrial materials
may be brought home in clothing resulting in the potential exposure of
non-working pregnant women, makes studies of teratogenicity of agents to
which male workers are exposed as important as studies of infertility
and mutagenicity; and

(3.) The possibility that childhood cancers may be related to pre-natal
environmental exposures.

NIOSH is offering both a challenge and an opportunity to talented
researchers interested in the study of reproductive effects from
occupational exposures.

II. AREAS OF RESEARCH INTEREST

The goal of this announcement is to stimulate and encourage high quality
research and demonstration grants in the areas of research listed below.
These areas are not mutually exclusive. It is anticipated that a given
research study may cut across several areas. Included under each listed
area are examples of the types of studies which would be of interest to
NIOSH. They are not meant to be restrictive and are cited for
illustrative purposes only.