[Federal Register: May 3, 2005 (Volume 70, Number 84)][Proposed Rules] [Page 22828-22835]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-17]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. H-016]
RIN 1218-AC11
Occupational Exposure to Ionizing Radiation
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Request for information.
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SUMMARY: OSHA requests data, information and comment on issues related
to the increasing use of ionizing radiation in the workplace and
potential worker exposure to it. Specifically, OSHA requests data and
information about the sources and uses of ionizing radiation in
workplaces today, current employee exposure levels, and adverse health
effects associated with ionizing radiation exposure. OSHA also requests
data and information about practices and programs employers are using
to control employee exposure, such as exposure assessment and
monitoring methods, control methods, employee training, and medical
surveillance. The Agency will use the data and information it receives
to determine what action, if any, is necessary to address worker
exposure to occupational ionizing radiation.
DATES: Comments must be submitted by the following dates:
Hard copy: Your comments must be submitted (postmarked or sent) by
August 1, 2005.
Facsimile and electronic transmission: Your comments must be sent
by August 1, 2005.
ADDRESSES: You may submit comments, identified by OSHA Docket No. H-
016, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions below for submitting comments.
Agency Web Site: http://ecomments.osha.gov. Follow the instructions
on the OSHA Web page for submitting comments.
Fax: If your comments, including any attachments, are 10 pages or
fewer, you may fax them to the OSHA Docket Office at (202) 693-1648.
Mail, express delivery, hand delivery and courier service: You must
submit three copies of your comments and attachments to the OSHA Docket
Office, Docket H-016, Room N-2625, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2350 (OSHA's TTY number is (877) 889-5627). OSHA Docket Office and
Department of Labor hours of operations are 8:15 a.m. to 4:45 p.m., ET.
Instructions: All submissions received must include the Agency name
and docket number (H-016). All comments received will be posted without
change on OSHA's Web page at http://www.osha.gov, including any
personal information provided. For detailed instructions on submitting
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read comments or background
documents received, go to OSHA's Web page. Comments and submissions are
also available for inspection and copying at the OSHA Docket Office at
the address above.
FOR FURTHER INFORMATION CONTACT: Press inquiries: Kevin Ropp, OSHA
Office of Communications, Room N-3647, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone: (202) 693-
1999.
General and technical information: Dorothy Dougherty, Acting
Director, OSHA Directorate of Standards and Guidance, Room N-3718, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone: (202) 693-1950.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Introduction
B. Sources of ionizing radiation exposure
1. Natural sources of workplace exposure
2. Radiation that results from industrial activity
C. Workplace uses of ionizing radiation
1. Emergency response and security
2. Medical
3. Manufacturing and construction
4. Food and kindred products
D. Health effects
II. Regulatory history
III. Request for data, information and comments
A. Sources of ionizing radiation exposure and occupational uses
B. Emergency response and security
C. Employee exposure to ionizing radiation
D. Health effects
E. Risk assessment
F. Exposure assessment and monitoring
G. Control of ionizing radiation
H. Employee training
I. Medical surveillance
J. Economic impacts
K. Environmental effects
L. Duplication/overlapping/conflicting rules
IV. Public participation
V. Authority and signature
I. Background
A. Introduction
Although ionizing radiation has been used in workplaces since 1896,
its use has grown significantly in recent years. For example, the use
of X-ray equipment to inspect luggage, packages and other items has
become very widespread. Currently, ionizing radiation is also used to
neutralize harmful biological agents, including anthrax, as well as
microorganisms in certain food.
OSHA seeks data, information and comment on current uses of
ionizing radiation in the workplace and issues related to that use,
such as employee exposure levels, health effects of ionizing radiation
exposure, and workplace programs to control ionizing radiation
exposure. OSHA, in consultation with other Federal agencies, will use
the data and information submitted to determine if action is necessary
given the increased occupational use of ionizing radiation. In
particular, OSHA is interested in obtaining information that will allow
assessment of the appropriateness of revising its standard for
occupational exposure to ionizing radiation (29 CFR 1910.1096).
OSHA regulates worker exposure to ionizing radiation under the
authority granted by the Occupational Safety and Health Act of 1970
(the Act) (29 U.S.C. 651 et seq.). Several other Federal agencies also
have responsibility to regulate worker exposure to ionizing radiation
under certain circumstances. The Department of Energy (DOE) regulates
exposure to ionizing radiation for employees at DOE facilities
including both Federal workers and contractor employees. Similarly, the
Department of Defense (DOD) is responsible for worker exposures to
ionizing radiation in DOD facilities and operations. The Nuclear
Regulatory Commission (NRC) regulates worker exposure to ionizing
radiation for specific materials for which NRC issues licenses. The
Mine Safety and Health Administration (MSHA), regulates miner's
exposure to ionizing radiation from short lived decay products
(daughters) of radon and thoron gases and gamma radiation from
radioactive ores in underground metal and nonmetal mines (30 CFR
57.5035-57.5047). OSHA standards cover worker exposures from all other
radiation sources not identified above, including X-ray equipment,
accelerators, accelerator-produced materials, electron microscopes and
naturally occurring radioactive materials (NORM). OSHA continues to
work with NRC, DOE, DOD and the Environmental Protection Agency (EPA)
on advances in the scientific information dealing with worker exposure
and Federal policy addressing this important issue. OSHA will also
continue its involvement with the Interagency Steering Committee on
Radiation Standards in an effort to coordinate any future activity.
B. Sources of Ionizing Radiation Exposure
There are many and diverse sources of exposure to ionizing
radiation and conditions in which employees can be exposed. Exposures
can result from natural sources, such as radioactive materials that
exist in the soil, and from cosmic sources (i.e., the sun). Workers can
also be exposed to radiation from sources that result from human
activities. For example, exposure to ionizing radiation can result from
NORM, or from equipment that emits radiation such as X-ray devices.
1. Natural sources of workplace exposure. Exposure to radioactivity
can occur in virtually every human environment. A primary source of
external exposure is cosmic radiation from the sun, mostly in the form
of low-level gamma radiation. Exposure rates increase with increasing
altitude so, for example, the exposure to cosmic radiation in an
airplane at 30,000 feet is greater than at ground level. Other exposure
comes from NORM that are found in the earth's crust (e.g., uranium,
thorium, and radon) (Exs. 1-1; 1-2; 1-3; 1-4). Everyone is exposed to
small amounts of radiation (gamma radiation, alpha and beta particles)
that result from these radionuclides and their decay products. The
amount of exposure to naturally occurring sources varies widely because
the level of radioactivity in soil or water in different locations
varies. Along with external exposures, people are exposed internally by
eating foods and drinking water containing NORM (Exs. 1-3; 1-4).
2. Radiation that results from industrial activity. Worker exposure
to ionizing radiation also takes place when naturally occurring
radioactive material is ``enhanced'' in some way. Technologically
enhanced naturally occurring radioactive materials (TENORM) are created
when industrial activity enhances the concentrations of radioactive
materials or when the material is redistributed as a result of human
intervention or industrial processes and this can result in increased
worker exposures. TENORM can result from manufacturing processes, such
as the production of materials and equipment from raw materials that
contained NORM, and concentrations of these materials are sometimes
increased as a result of these processes. Another example is increased
concentrations of NORM materials in filters and the solid sludge from
large quantities of water used in some manufacturing processes, such as
paper and pulp mills, or from water treatment systems used to supply
drinking water. Workers who clean or change filters or handle sludge
may be exposed to these increased concentrations. In addition,
downstream use of materials containing TENORM, such as coal ash,
aluminum oxide, and fertilizers can result in employee exposure (Ex. 1-
3).
TENORM also can be the byproduct or waste product of oil, gas and
geothermal energy production (Exs. 1-2; 1-3). Sludge, drilling mud, and
pipe scales are examples of materials that often contain elevated
levels of NORM, and the radioactive materials may be moved from site to
site as equipment and materials are reused.
Disposal, reuse and recycling of TENORM can cause occupational
exposures. For example, reusing concrete aggregate contaminated with
TENORM (i.e., phosphate slag) can lead to increased radiation exposure
for construction workers (Exs. 1-2; 1-3).
In addition to NORM and TENORM, accelerator produced radioactive
material that results from operation of atomic particle accelerators
for medical, research or industrial purposes can cause occupational
exposures. When reference is being made to both naturally and
accelerator produced radioactive materials the acronym NARM is used.
NARM is a term used to describe naturally occurring radioactive
material including TENORM, discussed above and accelerator produced
material that results from the operation of atomic particle
accelerators for medical, research, or industrial purposes. The
accelerator uses magnetic fields to move atomic particles at increasing
velocities before crashing into a pre-selected target. This reaction
produces desired radioactive materials in metallic targets or kills
cancer cells where a cancer tumor is the target. However, it also
produces some radioactive waste products that are frequently managed as
low-level radioactive waste. The radioactivity contained in the waste
from accelerators is generally short-lived.
Equipment that produces ionizing radiation is another source of
workplace exposure. X-ray equipment and electron microscopes are some
of the OSHA-regulated sources of worker exposure to ionizing radiation
(Exs. 1-5; 1-6).
C. Workplace Uses for Ionizing Radiation
Ionizing radiation is used extensively throughout a wide range of
industries. The following are just a few of the many and increasing
industrial uses of ionizing radiation.
1. Emergency response and security. Since OSHA's Ionizing Radiation
standard was adopted, the use of X-ray equipment for security purposes
has grown significantly. It is used to check the contents of baggage,
parcels, vehicles and other items at airports, border crossings,
seaports, postal facilities, building entries, public events, and
parking facilities, among other places. Another recent use of ionizing
radiation is to neutralize biological agents sent through the mail and
other delivery methods. Workers can be exposed to ionizing radiation
when these types of equipment are maintained improperly or if safety
shielding is damaged (Exs. 1-5; 1-6).
Exposures exceeding occupational limits also may occur in emergency
situations. The primary occupational safety and health standard for
emergency response to an ionizing radiation release is the OSHA
Hazardous Waste Operations and Emergency Response (HAZWOPER) standard
(29 CFR 1910.120). Because Federal OSHA does not cover State and
municipal workers in States that do not have their own OSHA approved
occupational safety and health program (i.e., non-State Plan States),
EPA applies OSHA's HAZWOPER standard to them (40 CFR part 311). In
addition, the NRC and DOE ionizing radiation regulations have
provisions that address emergency response situations and include
exemptions from exposure limits in those situations.
There also is increased awareness of the possibility for the
intentional release of radioactive materials as part of terrorist
activities (i.e., radioactive dispersion device (RDD) or ``dirty
bomb'', or an improvised nuclear device (IND)). Currently, the
Department of Homeland Security (DHS) is developing guidelines for
responding to terrorist attacks that may result in the release of
ionizing radiation. OSHA would provide technical assistance for such an
event in cooperation with other Federal agencies.
2. Medical. The use of ionizing radiation in medicine also
continues to grow. Non-NRC regulated medical uses can be divided into
two areas: Diagnostic/imaging techniques and radiotherapy. Imaging
techniques include radiography, fluoroscopy, angiography and computed
tomography. These imaging techniques are used to perform medical
procedures such as cardiac catheterizations; to locate fractures,
growths and tumors; to determine the extent of an injury or disease;
and to determine the necessity for other medical procedures such as
dental work.
Radiotherapy involves the use of ionizing radiation for treatment
of diseases such as cancer (Exs. 1-7; 1-8). Non-NRC regulated
radiotherapy includes the use of X-rays and accelerators.
3. Manufacturing and construction. There are many common uses of
ionizing radiation in manufacturing and construction. Ionizing
radiation is used, for example, in inspecting welds, measuring the
thickness of microelectronic wafers, developing polymers in the rubber
and plastics industries, and measuring and inspecting the quantity and
quality of goods produced.
Ionizing radiation is used for precision measuring and
nondestructive testing to increase quality and uniformity and reduce
waste (Exs. 1-8; 1-9). For instance, X-rays are used in the lumber
industry to search for knots and other imperfections in board products
and to determine moisture content.
In addition, precision measurement and nondestructive testing is
important to ensure the safety and health of goods, construction
projects, and repairs. For example, employers use ionizing radiation to
inspect welds, tires, materials, and machines for defects that could
result in death or serious injury or illness. X-rays are used to
inspect welds in shipbuilding, automotive and aerospace production. In
the construction industry, X-rays are used to measure cement density,
to inspect structural materials for fatigue, and to inspect paint for
the presence and quantity of lead.
Finally, TENORM wastes can be used in manufacturing and
construction. For instance, coal ash can sometimes be incorporated into
building materials as a filler and concrete strengthener. Zircon
mineral grains, a form of TENORM, which contains small amounts of
radionuclides in the mineral matrix, can be ground into fine powder and
are commonly applied to ceramics before firing to create a shiny glaze.
Ionizing radiation, in the form of electron beams, has long been
used to alter the chemical or physical properties of materials without
the use of toxic substances or expensive processes. Electron beams can
increase the strength, environmental resistance, and fire retardation
of materials such as cable insulation and plastics. Electron beams are
also used to bind the coating on non-stick pots and pans and to give
garments the ability to repel water. Curing of adhesives and resins
with electron beams is an emerging technology for the rapid
manufacturing of components and composite structures for aerospace,
automotive and consumer applications (Ex. 1-9).
4. Food and kindred products. The application of ionizing radiation
to food as a means of improving food safety is gradually being
implemented in the United States (Exs. 1-9; 1-10). In recent years, the
use of ionizing radiation to kill microorganisms in food has grown. The
Food and Drug Administration (FDA) allows irradiation of poultry, pork
and ground beef. Ground beef is irradiated to eradicate E-coli, a
potentially lethal organism. Using ionizing radiation (e.g., electron
beam, X-ray) also helps to extend the shelf life of fresh meats. In
addition, FDA permits the irradiation of spices and seasonings. A
related use of ionizing radiation in the food industry is the creation
of aseptic food packaging materials to eliminate the possibility of
transferring infectious microorganisms to people (Ex. 1-10). (Although
the process of food irradiation is governed by FDA regulations (21 CFR
part 179), these regulations do not include requirements to protect
employees from ionizing radiation exposure.)
X-rays are commonly used in the food industry for inspection,
grading and sorting of food, such as fruit and eggs. Employers also use
X-rays to inspect canned beverages for defects and metal contaminants
in the cans.
D. Health Effects
There is a large body of scientific research and literature on the
health effects of ionizing radiation exposure (e.g., Exs. 1-4; 2-1
through 2-25). In addition, there are a number of detailed reviews and
evaluations of the scientific literature base. The National Research
Council has conducted several reviews and evaluations of peer-reviewed
studies of the effects of ionizing radiation exposure. In 1990, the
National Research Council's Committee on the Biological Effects of
Ionizing Radiation (BEIR) issued a report (BEIR V) on the ``Health
Effects of Exposure to Low Levels of Ionizing Radiation'' (Ex. 1-11).
Currently, the BEIR Committee is in the process of updating its review
of scientific studies on the effects of low-level ionizing radiation
exposure with its results to be published as BEIR VII. OSHA will place
this report in the docket when it is published. The International
Agency for Research on Cancer (IARC) has published critical reviews and
evaluations of the evidence of carcinogenicity of ionizing radiation
exposure (i.e., IARC Volume 75 Monographs (2000), Ex. 1-12).
These studies indicate that the health effects associated with
exposure to ionizing irradiation vary depending on the total amount of
energy absorbed, the time period, the dose rate and the particular
organ exposed (Exs. 1-4; 1-11; 1-13; 1-14). Ionizing radiation affects
individuals by depositing energy in the body which can damage cells or
change their chemical balance (Exs. 1-4; 1-11; 1-12; 1-15; 1-16). In
some cases, exposure to ionizing radiation may not result in any
adverse health effects (Exs. 1-1; 1-4; 1-11; 1-12). In other cases, the
irradiated cell may survive but become abnormal, either temporarily or
permanently, and eventually may become cancerous (Exs. 1-1; 1-2; 1-4;
1-11; 1-12; 1-14; 1-15; 1-16).
Large doses of ionizing radiation can cause extensive cellular
damage and death (Exs. 1-1; 1-2; 1-4; 1-13). Epidemiological data on
survivors of the atomic bombs, dropped during World War II on Hiroshima
and Nagasaki, comprise the largest body of evidence on the effects of
high levels of ionizing radiation exposure (Exs. 1-4; 1-11; 1-16).
These data demonstrate a higher incidence of cancer among exposed
individuals and an increased probability of cancer as the level of
exposure increases (Exs. 1-4; 1-11; 1-16). Current Federal regulations
prohibit employee exposure to large doses of ionizing radiation.
Health effects from exposure to radiation may occur shortly after
exposure, may be delayed, or both. Some health effects may not manifest
themselves for months or years. For instance, for leukemia, the minimum
latency period is about two years. For solid tumors, the latency period
may be more than five years. The types of effects, latency period, and
probability of occurrence can depend on the magnitude of the exposure
and whether exposure occurs over a long period (i.e., chronic) or
during a very short period (i.e., acute). Health effects resulting from
chronic exposure (continuous or intermittent) to low levels of ionizing
radiation are typically delayed effects. Some of these effects may
include genetic defects, cancer, pre-cancerous lesions, benign tumors,
skin changes and congenital defects (Exs. 1-2; 1-4; 1-11; 1-16). On the
other hand, acute exposures (i.e., one large dose or a series of doses
for a short period of time) can cause both more immediate and delayed
effects. The more immediate effects may include radiation sickness
(e.g. hemorrhaging, anemia, loss of body fluids and bacterial
infections) (Ex. 1-2). Delayed effects of acute exposure may include
genetic defects and cancer as described above, along with sterility
(Exs. 1-2; 1-4; 1-11; 1-16). Extremely high levels of exposure can
result in death within hours, days or weeks (Ex. 1-2).
A variety of cancers have been associated with exposure to ionizing
radiation including leukemia, and cancers of the lung, stomach,
esophagus (Ex. 1-11), bone, thyroid (Ex. 1-17), and the brain and
nervous system (Exs. 1-16; 1-17).
Exposure to ionizing radiation also may damage developing embryos
and fetuses and may damage parental genetic material (DNA) (Exs. 1-4;
1-11). When the reproductive organs are exposed to ionizing radiation,
genetic effects may occur. It may not be possible to identify whether a
particular abnormality in a child is the result of the parent having
been exposed to ionizing radiation prior to the child's conception. The
abnormality may have multiple causes, including genetic or mutagenic
effects from exposure of either parent (Exs. 1-11; 1-18).
The biological effects of ionizing radiation exposure on developing
embryos and fetuses also are a concern because cells are rapidly
multiplying into specific organs and tissues. These effects are
generally associated with exposures at levels lower than what it would
take for similar effects to occur in adults. Some studies suggest that
a single, large dose at a critical phase of development may be more
damaging than smaller doses spread across the gestation period. As
mentioned, the developmental effects of in utero exposure to ionizing
radiation can occur shortly after exposure or be delayed (Exs. 1-16; 1-
19).
Currently, several Federal agencies are conducting studies to
further examine the health effects related to low levels of ionizing
radiation exposure. For BEIR VII, EPA, DOE, DOD, DHS and NRC are
jointly funding a National Academy of Science study into the ``Health
Effects of the Exposure to Low Levels of Ionizing Radiation.'' DOE is
also funding the Low Dose Radiation Research Program to understand the
biological responses of molecules, cells, tissues, organs, and
organisms to low doses of radiation. This program will ensure that
research results are communicated openly to scientists, decision
makers, and the public. Results will be used in at least two ways: (1)
To evaluate models that predict human health risks from exposure to low
doses of radiation, and (2) to help determine whether current radiation
protection standards reflect the most recent scientific data. It is
anticipated that research in the Low Dose Radiation Research Program
will produce data that will help improve understanding of the health
impact from exposure to low level radiation. Also, as mentioned, BEIR
VII is expected to be completed soon. In addition, the International
Commission on Radiation Protection (ICRP) is developing new
recommendations on radiation protection, all of which OSHA will place
in the docket. OSHA will review these studies and documents in
determining whether additional action may be necessary to protect
workers from ionizing radiation.
II. Regulatory History
OSHA's existing standard on ionizing radiation was adopted in 1971
pursuant to section 6(a) of the Act (29 U.S.C. 655). This section
allowed OSHA, during the first two years after passage of the Act, to
adopt as OSHA safety and health standards, existing Federal and
national consensus standards. The Ionizing Radiation standard was
adopted primarily from standards promulgated under the Walsh-Healey
Public Contracts Act, as amended (41 U.S.C. 35 et seq.), which
specified safety and health rules applicable to government contractors.
The Walsh-Healey standards on ionizing radiation, in turn, were taken
from standards issued by the Atomic Energy Commission (AEC), now the
NRC (10 CFR part 20). OSHA's provisions on immediate evacuation warning
signals (29 CFR 1910.1096(f)) were adopted from the ANSI N2.3 standard
on ``Immediate Evacuation Signal for Use in Industrial Installations
Where Radiation Exposure May Occur'' (1967) (36 FR 10523 (5/29/71).
OSHA's Ionizing Radiation standard adopted the radioactive
materials exposure limits that AEC issued in 1969 (10 CFR part 20,
Appendix B, Tables I and II). The NRC standards have been revised
several times since 1969. For example, changes have been made which
reduced occupational exposure limits and changed the models used to
estimate exposure from radioactive materials in the body. The
requirements of OSHA's Ionizing Radiation standard have not been
revised since they were adopted in 1971, therefore, the 1969 exposure
limits still apply. (Pursuant to section 6(a) of the Act, OSHA adopted
the Ionizing Radiation standard for the construction industry, 29 CFR
1926.53, in part from standards issued under section 107 of the
Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et seq.).
In 1996, OSHA incorporated by reference in the construction standard the
requirements of Ionizing Radiation standard covering general industry.)
OSHA's Ionizing Radiation standard applies to all workplaces except
agricultural operations and, as mentioned above, those workplaces
exempted from OSHA jurisdiction under section 4(b)(1) of the Act (29
U.S.C. 653). Section 4(b)(1) states:
Nothing in this Act shall apply to working conditions of employees
with respect to which other Federal agencies, and State agencies
acting under section 274 of the Atomic Energy Act of 1954, as
amended (42 U.S.C. 2021), exercise statutory authority to prescribe
or enforce standards or regulations affecting occupational safety
and health.
NRC has statutory authority for licensing and regulating nuclear
facilities and materials as mandated by the Atomic Energy Act of 1954
(as amended), the Energy Reorganization Act of 1974 (as amended), the
Nuclear Nonproliferation Act of 1978, and other applicable statutes.
Specifically, the NRC has the authority to regulate source, by-product
and certain special nuclear materials (e.g., nuclear reactor fuel).
This authority covers radiation hazards in NRC-licensed nuclear
facilities produced by radioactive materials and plant conditions that
affect the safety of radioactive materials and thus present an
increased radiation hazard to workers. In 1988, OSHA and NRC signed a
memorandum of understanding (MOU) delineating the general areas of
responsibility of each agency (CPL 2.86, December 22, 1989). The MOU
specifies that, at NRC-licensed facilities, OSHA has authority to
regulate occupational ionizing radiation sources not regulated by NRC
(CPL 2.86). Examples of non-NRC regulated radiation sources include X-
ray equipment, accelerators, accelerator-produced materials, electron
microscopes, betatrons, and some naturally occurring radiation sources
and TENORM (CPL 2.86). In addition to Federal regulation of ionizing
radiation exposure, States have radiation control programs for sources
of exposure within their state. NRC has 33 Agreement State Programs.
OSHA has 26 State Plan States, of which 13 are Agreement States. A
number of other states have some radiation protection program but are
neither NRC Agreement States nor OSHA State Plan States.
To promote a coordinated and effective Federal program for the
protection of workers exposed to ionizing radiation, the Federal
Radiation Protection Guidance was issued in 1960 (25 FR 4402 (5/18/60))
and an updated Federal Guidance document was issued in 1987 (52 FR 2822
(1/27/87)). The purpose of the Federal Guidance document is to help
Federal agencies in developing or revising their regulations addressing
ionizing radiation exposure. The 1987 Federal Guidance document was
developed collectively by 10 Federal agencies. The EPA conducted or
sponsored four major studies to support the review. The 1987 Federal
Guidance document generally incorporated recommendations on the limits
for occupational exposure and the approach to radiation protection that
the ICRP published in 1977. However, the ICRP recommendations have been
updated, most recently in 1990 (Ex. 1-13). Further revisions of the
ICRP recommendations are currently being considered. (The 1990 ICRP
recommendations have also been adopted in most other countries.)
OSHA will consider the 1987 Federal Guidance document and
supporting materials in determining whether to initiate rulemaking; and
if so, what approach the Agency should follow in revising the existing
rule. At the same time, because the data on which this document is
based are now at least 27 years old, OSHA will also consider more
recent scientific information and ICRP recommendations.
III. Request for Data, Information and Comments
The increasing use of ionizing radiation in the workplace presents
a number of complex issues. OSHA is seeking information, data, and
comment to determine what action, if any, OSHA needs to take to address
these issues. Specifically, OSHA requests comment on the issues and
questions listed below. OSHA also invites comment on any other issue
concerning workplace exposure to ionizing radiation. When commenting on
the specific numbered issues below, OSHA requests that you reference
the issue number. OSHA also requests that you explain and provide data
and information to support your comments. In addition, OSHA requests
that you submit with your comments any studies or articles that you
reference in support of your comments.
While the Agency is specifically seeking information on those
operations covered by OSHA regulations, as identified above, all
interested persons are encouraged to respond to the questions below.
A. Sources of Ionizing Radiation Exposure and Occupational Uses
1. How and where does your establishment and industry use ionizing
radiation? If possible, please provide workplace and industry-specific
data about the types and amounts of ionizing radiation used, its form,
and the processes and products in which it is used.
2. Are there new and emerging uses of ionizing radiation in your
establishment and industry? Please explain how and for what purpose
this ionizing radiation is or will be used.
3. What types of TENORM are present in your establishment and
industry? Please provide data and information on the source(s) of
TENORM that may be present.
B. Emergency Response and Security
4. Is ionizing radiation used for security-related purposes in your
establishment and industry? What equipment and devices are used and how
are they used? What measures are in place in your establishment and
industry to protect employees from exposure to these sources of
ionizing radiation?
5. If your establishment and industry uses radioactive materials,
what measures and preparations are in place in your establishment and
industry to protect employees performing emergency response and cleanup
when the release of ionizing radiation occurs, including intentional
release?
6. What action(s) should OSHA take to protect employees from
ionizing radiation exposure when responding to emergency situations,
including unintentional and intentional releases of radioactive
materials? Should OSHA address hazards associated with emergency
response to an ionizing radiation release by revising the existing
standards or promulgating a separate standard to address this hazard?
Please explain what provisions any standard should include.
7. What actions should be taken to ensure the protection of the
emergency responders (e.g., police, fire and medical), support workers
and other employees responding to the release?
8. To what extent should any action OSHA takes to address emergency
response situations reflect information and recommendations in the EPA
Protective Action Guide (PAG) Manual (EPA 400-R-92-001 (1991))? The PAG
Manual is available at http://www.epa.gov.
C. Employee Exposure to Ionizing Radiation
9. In your establishment and industry, how many or what percentage
of employees are exposed to or have potential for exposure to ionizing
radiation during routine operations? How many or what percentage of
employees work in ``restricted areas,'' as defined in the existing
Ionizing Radiation standard (29 CFR 1910.1096(a)(3))?
10. In what jobs or job categories are these employees found?
Please explain and describe the source(s) of employee exposure or how
exposure occurs.
11. What are employee radiation exposure levels in each of these
jobs and job categories? If possible, please provide personal dosimetry
exposure data. Please identify the frequency and duration of employee
exposure, and the type of sampling and analytical methods used to
determine exposure levels.
D. Health Effects
OSHA has placed in the docket articles and studies on the adverse
health effects of exposure to ionizing radiation, including BEIR V and
the IARC Volume 75 Monographs (Exs. 1-11; 1-12; 2-1 through 2-25). As
mentioned, OSHA will also add new ICRP recommendations, the EPA/DOE/
DOD/DHS/NRC-funded study and resultant BEIR VII to the docket when they
become available. OSHA requests comment on all of these studies and
documents. (Please do not submit these documents or the studies
referenced in them or any other documents referenced in this Federal
Register notice.) In particular, OSHA requests comment on how the risk
assessment information contained in these documents should be
interpreted in the context of the significant risk determination
required by the Act (29 U.S.C. 655(b)(5)) and cases interpreting it
(e.g., American Textile Manufacturers Institute, Inc. v. Donovan, 452
U.S. 490 (1981) (Cotton dust); Industrial Union Department, AFL-CIO v.
American Petroleum Institute, 448 U.S. 607 (1980) (Benzene)). OSHA also
requests that persons submit and comment on other recent articles and
studies that may be useful in identifying and assessing adverse health
effects related to occupational exposure to different types of ionizing
radiation.
12. Are there any articles, studies, or information, not already
identified, indicating that adverse health effects of ionizing
radiation exposure occur at levels lower than the exposure limits in
OSHA's current Ionizing Radiation standard? Please discuss and submit
those studies along with your comments.
13. What are the characteristics of different types of ionizing
radiation that are related to the development of adverse health
effects? Please describe and discuss or submit any articles and studies
that address this issue.
14. To what extent do different ionizing radiation types and
energies have specific properties (e.g., penetration) that should be
considered when assessing health risks? Please describe and discuss or
submit any articles and studies that address this issue.
15. What are the mechanisms of action of ionizing radiation in the
development of the different types of adverse health effects such as
cancer? Please describe and discuss or submit any articles and studies
that address this issue.
16. What are the combined effects of exposure to different types of
ionizing radiation and the effects of ionizing radiation when combined
with other environmental contaminants? Please describe and discuss or
submit any articles and studies that address this issue.
17. What is the role, if any, of genetic factors in the development
of adverse health effects related to ionizing radiation exposure?
Please describe and discuss or submit any articles and studies that
address this issue.
18. What studies, articles or other information should OSHA
consider and give weight to in assessing potential adverse health
effects associated with exposure to ionizing radiation? Please explain
why you recommend the particular articles and studies. Please describe
their strengths and weaknesses, such as population size,
characterization of exposure, or confounding factors.
19. What adverse health effects, if any, have any employees in your
establishment and industry experienced from exposure to ionizing
radiation? Please describe and, if possible, provide data and
information on their exposure history and exposure levels.
E. Risk Assessment
OSHA is interested in data and information that will assist the
Agency in developing quantitative estimates of the risk of adverse
health effects from occupational exposure to ionizing radiation. In
particular, OSHA seeks case reports and epidemiological and animal
studies along with associated exposure data.
20. Which approaches (i.e., methods, models, data) should OSHA use
to estimate the risk of adverse health effects from exposure to
ionizing radiation? Please explain and discuss or submit any articles
and studies that address this issue.
21. Which mathematical models are most appropriate to quantify the
risk of cancer or other adverse health effects from ionizing radiation
exposure?
22. In particular, which mathematical models are appropriate to
characterize alpha or beta particle lung deposition? Please describe
the strengths and weaknesses of these mathematical models.
23. What is the dose-response behavior of ionizing radiation,
including cellular, mechanistic, and dosimetric considerations? Are any
adverse health effects dependent on the time period over which exposure
occurs rather than on the total cumulative dose received? Are there
studies or data indicating that ionizing radiation exhibits a threshold
effect? Please describe and discuss and submit any articles and studies
that address these issues.
24. How should the risk assessment address the issue of workers who
may wish to conceive children? How should the risk assessment address
potential adverse health effects of ionizing radiation exposure on
developing fetuses? How does your establishment and industry address
the specific concerns of workers who are trying to conceive children
and workers who are pregnant? How should the standard address the risk
of reproductive and developmental health effects?
25. What studies should OSHA consider or give weight to in doing a
quantitative risk assessment for different types of adverse health
effects associated with ionizing radiation exposure? Please describe
and submit these studies and discuss their strengths and weaknesses.
26. The Interagency Steering Committee on Radiation Standards
(ISCORS) has prepared a technical report identifying a method for
estimating cancer risks related to ionizing radiation exposure in the
ambient environment (Ex. 1-15). To what extent would this method be
useful in characterizing or quantifying the risk of cancer from
ionizing radiation exposure in the workplace? What other methods of
assessment should OSHA consider?
F. Exposure Assessment and Monitoring
27. What methods (e.g., personal or area sampling, dosimetry,
objective data, engineering estimates) does your establishment and
industry use to initially survey or assess whether and to what extent
ionizing radiation exposures are present in the workplace? Please
explain why the particular method(s) is used.
28. When does your establishment and industry conduct exposure
surveys or initial exposure assessments? For example, does your
establishment and industry conduct surveys or assessments before
employees begin working in a new job or when new radiation equipment
or sources are introduced into the workplace? If so, please explain when
surveys or assessments are conducted and what they involve. If not,
please explain why.
29. Does your establishment and industry conduct periodic exposure
surveys or assessments? If not, please explain why. If so, please
explain why and how frequently periodic assessments are conducted and
what criteria are used to determine the frequency.
30. What methods does your establishment and industry use to
monitor employee exposure to ionizing radiation? Are there new methods
(other than film badges and pocket dosimeters) of monitoring or
measuring worker exposure to ionizing radiation? To what extent does
your establishment and industry use these methods? If possible, please
provide information on the precision and accuracy of these methods, the
range and limits of detection, the method of validation of sampling and
analysis, and potential sources of interference.
31. What procedures does your establishment and industry follow
when exposure monitoring results indicate that overexposures have
occurred?
G. Control of Ionizing Radiation
32. What programs have your establishment and industry implemented
to prevent or reduce employee exposure to ionizing radiation? Please
describe those control programs and their effectiveness in controlling
ionizing radiation exposure. To what extent have those programs
produced other additional workplace benefits or advantages such as
increased product quality or productivity?
33. To what extent does your establishment and industry use the
ALARA concept in limiting worker exposure to ionizing radiation? Please
describe those actions and the reductions in employee exposure that
have been achieved. Please explain whether and how the ALARA concept
(in conjunction with an exposure limit) would be relevant to revising
OSHA's Ionizing Radiation standard.
34. What engineering and work practice controls has your
establishment and industry implemented to prevent or reduce employee
exposure to ionizing radiation? In what jobs and operations have these
controls been implemented? Please describe their effectiveness in
reducing worker exposure and what criteria are used in measuring their
effectiveness.
35. To what extent does your establishment and industry use
contamination areas or isolated work areas to control radioactive
contamination? Please describe those measures and their effectiveness
in reducing employee exposure to ionizing radiation. What measures are
in place to prevent the spread of contamination out of these areas?
36. What housekeeping practices does your establishment and
industry use to control employee exposure to radioactive materials?
Please describe those housekeeping practices and cleaning methods
(e.g., vacuums with HEPA filters, tack cloths), the frequency they are
utilized, and any housekeeping practices that are prohibited.
37. Are there any jobs or operations where engineering, work
practice and administrative controls are not available, not effective,
or infeasible (technologically or economically) to control ionizing
radiation exposure? Please explain and describe what measures are in
place to protect employees from ionizing radiation exposure.
38. Does your establishment and industry provide employees with
respirators and other types of personal protective equipment (PPE)
(e.g., gloves, protective clothing) to protect against ionizing
radiation exposure? Please describe what PPE is provided, where and
under what conditions it is used (e.g., regulated areas, type of
operation, exposure level, exposure duration), the basis for selection,
and any difficulties implementing the PPE program.
39. What alternative technologies or substitutes for ionizing
radiation are available or in use in your establishment and industry?
Please describe these technologies or substitutes and how they work. To
what extent have these technologies reduced the frequency, duration and
magnitude of exposure to ionizing radiation? If possible, please
provide data and information on exposure levels and exposure reduction
associated with the application of these technologies. Are there any
technological or economic barriers or hindrances to implementing
available alternative technologies or substitutes? If so, please
explain what they are.
40. Are there emerging alternative technologies or substitutes that
may be available in the near future? Please describe them and, if
possible, provide information on when they may be available for use in
your establishment and industry.
41. DOE (10 CFR part 835) and NRC (10 CFR part 20) have regulations
to protect employees working at DOE facilities and with NRC-licensed
sources, respectively. To what extent does your establishment and
industry also follow these regulations in addition to the OSHA Ionizing
Radiation standard? Are there provisions in those regulations that
would also be effective in protecting employees from exposure to OSHA-
regulated sources of radiation? Please explain what those provisions
are and how they would be effective.
H. Employee Training
42. What information and training does your establishment and
industry provide to employees with potential exposure to ionizing
radiation? Please describe the information and training program. In
particular, please explain which employees receive training and the
selection criteria, training contents and methods, frequency and
duration of training, and procedures used to address language barriers.
43. How do you evaluate the effectiveness of training? What methods
do you use, and what factors do you consider in evaluating the
effectiveness of training?
I. Medical Surveillance
44. Does your establishment and industry provide medical monitoring
for employees who have potential exposure to ionizing radiation? Please
describe the medical monitoring program. Please explain which employees
receive medical monitoring, the criteria (e.g., job category, exposure
levels) used for determining when to provide medical monitoring, the
tests and procedures provided, and the frequency medical monitoring is
performed.
45. What have been the benefits and cost impacts of the medical
monitoring program? For example, what effect has medical monitoring had
on the number or severity of adverse health effects associated with
ionizing radiation exposure?
46. What measures and procedures does your establishment and
industry follow when an employee is overexposed to ionizing radiation
or is diagnosed with adverse health effects from exposure to ionizing
radiation?
J. Economic Impacts
47. What are the potential economic impacts associated with
revising the OSHA Ionizing Radiation standard to further reduce
occupational exposures? Please describe those impacts in terms of
benefits from reduction in the number or severity of illnesses and from
changes in worker productivity, costs of controls, medical
surveillance, exposure monitoring and training, effects on revenue and
profit, and any other relevant impact measure. To the extent possible,
please quantify or provide examples of costs (e.g., dollar estimates
for controls) and benefits (e.g., dollar estimates for medical savings
from a reduction in the number or severity of ionizing radiation-
related illnesses).
48. What changes, if any, in market conditions would reasonably be
expected to result by revising the Ionizing Radiation standard? Please
describe any changes in market structure or concentration and any
effects on domestic or international shipments of ionizing radiation-
related products or services that would reasonably be expected.
49. How many and what kinds of small entities are in your industry?
What percentage of the industry do they comprise?
50. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires
that OSHA assess the impact of proposed and final rules on small
entities. OSHA requests that members of the small business community
and others familiar with small business concerns address any special
circumstances small entities face in controlling occupational exposure
to ionizing radiation. How and to what extent would small entities in
your industry be affected by revising the Ionizing Radiation standard?
Are there special circumstances that make the control of ionizing
radiation more difficult or more costly in small entities? Please
describe those circumstances and explain and discuss any alternatives
that might serve to minimize these impacts.
51. Are there reasons why the benefits of revising the Ionizing
Radiation standard to further reduce employee exposure might be
different for small entities than for larger establishments?
K. Environmental Effects
The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C.
4321 et seq.), the Council on Environmental Quality (CEQ) regulations
(40 CFR part 1500), and the Department of Labor NEPA Compliance
Regulations (29 CFR part 11), require that OSHA give appropriate
consideration to environmental issues and the impacts of proposed
actions significantly affecting the quality of the human environment.
OSHA is currently collecting written information and data on possible
environmental impacts that could occur outside of the workplace (e.g.,
exposure to the community through contaminated air/water, contaminated
waste sites) if the Agency were to issue guidance or revise the
existing standard for occupational exposure to ionizing radiation. Such
information should include both negative and positive environmental
effects that could be expected to result from guidance or a revised
standard. Specifically, OSHA requests comments and information on the
following:
52. What is the potential direct or indirect environmental impact
(for example, the effect on air and water quality, energy usage, solid
waste disposal, and land use) from further reducing employee exposure
to ionizing radiation or from using new substitutes for ionizing
radiation?
53. Are there any situations in which reducing ionizing radiation
exposures to employees would be inconsistent with meeting environmental
regulations?
L. Duplication/Overlapping/Conflicting Rules
54. Are there any State or Federal regulations that might
duplicate, overlap or conflict with OSHA issuing guidance or a revised
standard concerning ionizing radiation? If so, identify which ones and
explain how they would duplicate, overlap or conflict.
55. Are there any Federal programs in areas such as defense, energy
or homeland security that might be impacted by guidance or a revised
standard concerning ionizing radiation? If so, identify which ones and
explain how they would be impacted.
IV. Public Participation
You may submit comments in response to this document by (1) hard
copy, (2) fax transmission (facsimile), or (3) electronically through
the OSHA Web page or the Federal Rulemaking Portal. Because of
security-related problems there may be a significant delay in the
receipt of comments by regular mail. Please contact the OSHA Docket
Office at (202) 693-2350 for information about security procedures
concerning the delivery of materials by express delivery, hand delivery
and courier service.
All comments and submissions are available for inspection and
copying at the OSHA Docket Office at the above address. Comments and
submissions posted on OSHA's Web page are available at http://www.osha.gov.
OSHA cautions you about submitting personal information
such as social security numbers and birth dates. Contact the OSHA
Docket Office for information about materials not available through the
OSHA Web page and for assistance in using the web page to locate docket
submissions.
Electronic copies of this Federal Register notice, as well as news
releases and other relevant documents, are available at OSHA's Web
page.
V. Authority and Signature
This document was prepared under the direction of Jonathan L.
Snare, Acting Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor. It is issued pursuant to sections 4,
6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C.
653, 655, 657), 29 CFR part 1911, and Secretary's Order 5-2002 (67 FR
65008).
Issued at Washington, DC, this 26th day of April 2005.
Jonathan L. Snare,
Acting Assistant Secretary of Labor.
[FR Doc. 05-8805 Filed 5-2-05; 8:45 am]
BILLING CODE 4510-26-P
