Current through Register Vol. 46, No. 39, September 25, 2024
(a) As used in
these regulations, these terms have the definitions set forth below:
(1) A1 means the
maximum activity of special form radioactive material permitted in a Type A
package. A2 means the maximum activity of radioactive
material, other than special form radioactive material, permitted in a Type A
package. These values are either listed or may be derived in accordance with
the procedure prescribed in Appendix 16-B, Table 1 of this Part.
(2)
Absorbed dose means the
energy imparted by ionixing radiation per unit mass of irradiated material. The
units of absorbed dose are the gray (Gy) and the rad.
(3)
Accelerator-produced
material means any material made radioactive by a particle
accelerator.
(4)
Activity means the rate of disintegration or transformation or
decay of radioactive material. The units of activity are the becquerel (Bq) and
the curie (Ci).
(5)
Adult means an individual 18 years, or more, or age.
(6)
Agreement state means
any state with which the United States Nuclear Regulatory Commission or the
United States Atomic Energy Commission has entered into an effective agreement
under section 274b of the Atomic Energy Act of 1954, as amended (73 Stat.
689).
(7)
Airborne
radioactive material means any radioactive material dispersed in the
air in the form of dusts, fumes, particulates, mists, vapors, or
gases.
(8)
Airborne
radioactivity area means a room, enclosure, or area in which airborne
radioactive materials exist in concentrations:
(i) in excess of the derived air
concentrations (DACs) specified in Appendix 16-C, Table 1, Column 3,
infra; or
(ii) to
such a degree that an individual present in the area without respiratory
protective equipment could exceed, during the hours an individual is present in
a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12
DAC-hours.
(9)
Aluminum equivalent means the thickness of aluminum affording
the same attenuation, under specified conditions, as the material in
question.
(10)
Annual limit
on intake (ALI) means the derived limit for the amount of radioactive
material taken into the body of an adult worker by inhalation or ingestion in a
year. ALI is the smaller value of intake of a given radionuclide in a year by
the reference man that would result in a committed effective dose equivalent of
0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any
individual organ or tissue. ALI values for intake by ingestion and by
inhalation of selected radionuclides are given in Appendix 16-C, Table 1,
Columns 1 and 2, infra.
(11)
As low as is reasonably
achievable (ALARA) means making every reasonable effort to maintain
exposures to radiation as far below the dose limits in these regulations as is
practical, consistent with the purpose for which the licensed or registered
activity is undertaken, taking into account the state of technology, the
economics of improvements in relation to state of technology, the economic of
improvements in relation to benefits to the public health and safety, and other
societal and socioeconomic considerations, and in relation to utilization of
nuclear energy and licensed or registered sources of radiation in the public
interest.
(12)
Background
radiation means radiation from cosmic sources; naturally occurring
radioactive materials, including radon, except as a decay product of source or
special nuclear material, and including global fallout as it exists in the
environment from the testing of nuclear explosive devices. Background
radiation does not include sources of radiation from radioactive
materials regulated by the department.
(13)
Becquerel (Bq) means
the SI unit of activity. One becquerel is equal to one disintegration or
transformation per second (s-1).
(14)
Bioassay means the
determination of kinds, quantities or concentrations, and, in some cases, the
locations of radioactive material in the human body, whether by direct
measurement, in vivo counting, or by analysis and evaluation of materials
excreted or removed from the human body. For purposes of these regulations,
"radiobioassay" is an equivalent term.
(15)
Byproduct material shall
include:(i) any radioactive
material, except special nuclear material, yielded in or made radioactive by
exposure to the radiation incident to the process of producing or utilizing
special nuclear material;
(ii) the
tailings or wastes produced by the extraction or concentration of uranium or
thorium from ore processed primarily for its source material content, including
discrete surface wastes resulting from uranium or thorium solution extraction
processes; however, ore bodies depleted by these solution extraction operations
do not constitute "byproduct material" within this definition;
(iii) any discrete source of radium-226 that
is produced, extracted, or converted after extraction for use for a commercial,
medical, or research activity;
(iv)
any material that has been made radioactive by use of a particle accelerator
and is produced, extracted, or converted after extraction for use for a
commercial, medical, or research activity;
(v) any discrete source of naturally
occurring radioactive material, other than source material, that is extracted
or converted after extraction for use in a commercial medical or research
activity that the Nuclear Regulatory Commission, in consultation with the
Administrator of the Environmental Protection Agency, the Secretary of Energy,
the Secretary of Homeland Security, and the head of any other appropriate
Federal agency, determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the common
defense and security.
(16)
Calendar quarter means
not less than 12 consecutive weeks nor more than 14 consecutive weeks. The
fibst calendar quarter of each year shall begin in January and subsequent
calendar quarters shall be so arranged such that no day is included in more
than one calendar quarter and no day in any one year is omitted from inclusion
within a calendar quarter. No licensee or registrant shall change the method
used to determine calendar quarters for purposes of these regulations except at
the beginning of a calendar year.
(17)
Calibration means the
determination of:
(i) the response or reading
of an instrument relative to a series of known radiation values over the range
of the instrument; or
(ii) the
strength of a source of radiation relative to a standard.
(18)
Certified radiation equipment
safety officer means an individual who holds an unexpired certificate
as a radiation equipment safety officer issued by the department.
(i) The requirements for certification as a
radiation equipment safety officer are as follows:
(a) at least 18 years of age at the time of
application; and
(b) good moral
character; and
(c) graduation from
a regionally accredited college or university, or one recognized by New York
State, with a bachelor's degree in physical or natural science, mathematics or
engineering; or four years of satisfying full-time paid experience in radiation
protection or control; or an equivalent combination of the education and
experience specified in this clause; and
(d) successful completion, after meeting the
requirements of clauses (a), (b), and
(c) of this subparagraph, of an examination prescribed by the
department: and
(e) at least three
years of satisfactory full-time paid experience in radiation protection or
control including at least one year of experience dealing with radiation
equipment, with the provision that up to two years of graduate training in
physical or natural science, mathematics or engineering, may be substituted on
a year for year basis for the required experience except for the one year of
experience in radiation protection or control dealing with radiation
equipment.
(ii) The
department may accept in lieu of the requirements of clauses
(i)(c) and (d) of this paragraph a
certificate in radiation protection or control issued by the American Board of
Health Physics, the American Board of Radiology or the American Board of
Medical Physics.
(iii) A person
meeting all requirements of subparagraph (i) of this paragraph except the
experience or experience substitute requirement of clause (i)
(e) of this paragraph may be certified as a radiation
equipment safety officer with the restriction that he/she perform surveys only
under the supervision of a certified radiation equipment safety officer who
meets the requirements of said clause (e).
(iv) A certification as a radiation equipment
safety officer shall be issued by the department for a period not to exceed two
years. Eligibility for renewal of a certificate shall be based on a work record
as a certified radiation equipment safety officer that is in conformance with
the regulations of the department. The certificate may be revoked for cause by
the department on due notice.
(19)
CFR means Code of
Federal Regulations.
(20)
Class means a classification scheme for inhaled material
according to its rate of clearance from the pulmonary region of the lung.
Materials are classified as D, W, or Y. which applies to a range of clearance
half-times: for Class D, Days, of less than 10 days, for Class W, Weeks, from
10 to 100 days, and for Class Y, Years, of greater than 100 days. For purposes
of these regulations, "lung class" and "inhalation class" are equivalent
terms.
(21)
Collective
dose means the sum of the individual doses received in a given period
of time by a specified population from exposure to a specified source of
radiation.
(22)
Collimator means a device or mechanism by which the X-ray or
gamma-ray beam is restricted in size.
(23)
Commissioner means the
Commissioner of Health of the State of New York.
(24)
Committed dose
equivalent (HT,50) means the dose equivalent to
organs or tissues of reference (T) that will be received from an intake of
radioactive material by an individual during the 50-year period following the
intake.
(25)
Committed
effective dose equivalent(H E,50) is the sum of
the products of the weighing factors applicable to each of the body organs or
tissues that are irradiated and the committed dose equivalent to each of these
organs or tissues (HE, = £ WT
HT,50).
(26)
Cone means a device used to indicate beam direction and to
establish a minimum source-surface distance. It may or may not incorporate a
collimator.
(27)
Controlled
area means any area the access to which is controlled for the purpose
of protecting individuals from exposure to radiation and radioactive material,
but shall not mean any area used as residential quarters. "Controlled area" as
used in this Part is synonymous to "restricted area".
(28)
Curie means a unit of
activity. One curie (Ci) is that quantity of radioactive material which decays
at the rate of 3.7 * 1010; transformations per
second (tps).
(29)
Declared
pregnant woman means a woman who has voluntarily informed her
employer, in writing, of her pregnancy.
(30)
Deep dose equivalent
(Hd), which applies to external whole body exposure,
means the dose equivalent at a tissue depth of one centimeter (1000
mg/cm2).
(31)
Department means the
New York State Department of Health and shall include its duly authorized
representatives.
(32)
Depleted uranium means the source material uranium in which
the isotope uranium-235 is less than 0.711 weight percent of the total uranium
present.
(33)
Derived air
concentration (DAC) means the concentration of a given radionuclide in
air which, if breathed by the reference man for a working year of 2,000 hours
under conditions of light work, results in an intake of one ALI. For purposes
of these regulations, the condition of light work is an inhalation rate of 1.2
cubic meters of air per hour for 2,000 hours in a year. DAC values are given in
Appendix 16-C, Table 1, Column 3, infra.
(34)
Derived air
concentration-hour (DAC-hour) means the product of the concentration
of radioactive material in air, expressed as a fraction or multiple of the
derived air concentration for each radionuclide, and the time of exposure to
that radionuclide, in hours. A licensee or registrant may use 2,000 DAC-hours
to represent one ALI, equivalent to a committed effective dose equivalent of
0.05 Sv (5 rem).
(35)
Diagnostic type protective tube housing means X-ray tube
housing so constructed that the leakage radiation at a distance of one meter
from the source does not exceed 100 milliroentgens in one hour when the tube is
operated at its maximum continuous rated current for the maximum rated tube
potential.
(36)
Diaphragm means a device or mechanism by which the X-ray or
gamma-ray beam is restricted in size.
(37)
Dose is a generic term
that means absorbed dose, dose equivalent, effective dose equivalent, committed
dose equivalent, committed effective dose equivalent, or total effective dose
equivalent. For purposes of these regulations, "radiation dose" is an
equivalent term.
(38)
Dose
equivalent (H T) means the product of the
absorbed dose in tissue, quality factor, and all other necessary modifying
factors at the location of interest. The units of dose equivalent are the
sievert (Sv) and rem.
(39)
Dose limits means the permissible upper bounds of radiation
doses established in accordance with these regulations. For purposes of these
regulations, "limits" is an equivalent term.
(40)
Dosimetry processor
means a person that processes and evaluates individual monitoring devices in
order to determine the radiation dose delivered to the monitoring
devices.
(41)
Effective
dose equivalent (HE) means the sum of the
products of the dose equivalent to each organ or tissue
(HT) and the weighting factor (W
T) applicable to each of the body organs or tissues that
are irradiated (HE = £ WT
HT).
(42)
Embryo/fetus means the developing human organism from
conception until the time of birth.
(43)
Entrance or access
point means any opening through which an individual or extremity of an
individual could gain access to radiation areas or to licensed or registered
radioactive materials. This includes entry or exit portals of sufficient size
to permit human entry, irrespective of their intended use.
(44)
Explosive material
means any chemical compound, mixture, or device which produces a substantial
instantaneous release of gas and heat spontaneously or by contact with sparks
or flame.
(45)
Exposure means either:
(i)
being exposed to ionizing radiation or to radioactive material; or
(ii) the quotient of dQ by dm where"dQ" is
the absolute value of the total charge of the ions of one sign produced in air
when all the electrons (negatrons and positrons) liberated by photons in a
volume element of air having mass "dm" are completely stopped in air. The
special unit of exposure is the roentgen (R). One roentgen is equal to 2.58 *
104 coulomb per kilogram of air.
(46)
Exposure
rate means the exposure per unit of time, such as roentgen per minute
and milliroentgen per hour.
(47)
External dose means that portion of the dose equivalent
received from any source of radiation outside the body.
(48)
Extremity means hand,
elbow, arm below the elbow, foot, knee, and leg below the knee.
(49)
Eye dose equivalent
means the external dose equivalent to the lens of the eye at a tissue depth of
0.3 centimeter (300 mg/cm2).
(50)
Former U.S. Atomic Energy
Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC)
licensed facilities means nuclear reactors, nuclear fuel reprocessing
plants, uranium enrichment plants, or critical mass experimental facilities
where AEC or NRC licenses have been terminated.
(51)
Gray (Gy) means the SI
unit of absorbed dose. One gray is equal to an absorbed dose of one
joule/kilogram. One gray is equal to 100 rad.
(52)
Half value layer (HVL)
means the thickness of a specified substance which, when introduced into the
path of a given beam of radiation, reduces the exposure rate by
one-half.
(53)
Health
officer having jurisdiction means the commissioner or his/her
designee, or the chief executive officer of the appropriate county or
part-county health department or the New York City Department of Health, or the
director of a state, regional, area or district office of public
health.
(54)
High radiation
area means any area, accessible to individuals, in which radiation
levels could result in an individual receiving a dose equivalent in excess of
one mSv (0.1 rem) in one hour at 30 centimeters from any source or radiation or
from any surface that the radiation penetrates. For purposes of these
regulations, rooms or areas in which diagnostic X-ray systems are used for
healing arts purposes are not considered high radiation areas.
(55)
Human use means the
internal or external administration of radiation of radioactive material to
human beings.
(56)
Image
receptor shall mean any device, such as fluoroscopic input phosphor or
radiographic film which transforms incident X-ray photons either into a visible
image or into another form which can be made into a visible image by further
transformation.
(57)
Individual shall mean any human being.
(58)
Individual monitoring
means the assessment of:
(i) dose equivalent
(a) by the use of individual monitoring
devices; or
(b) by the use of
survey data; or
(ii)
committed effective dose equivalent
(a) by
bioassay; or
(b) by determination
of the time-weighted air concentrations to which an individual has been
exposed, that is, DAC-hours.
(59)
Individual monitoring
devices means devices designed to be worn by a single individual for
the assessment of dose equivalent. For purposes of these regulations,
individual monitoring equipment and personnel monitoring equipment are
equivalent terms. Examples of individual monitoring devices are film badges,
thermoluminescent dosimeters (TLDs), pocket dosimeters, and personal air
sampling devices.
(60)
Inherent filtration means the filtration permanently in the
useful beam; it includes the window of the X-ray tube and any permanent tube or
source enclosure.
(61)
Inspection means an official examination or observation
including, but not limited to, reviews of records, tests, surveys, and
monitoring to determine compliance with rules, regulations, orders,
requirements, and conditions of the department.
(62)
Interlock means a
device arranged or connected such that the occurrence of an event or condition
is required before a second event or condition can occur or continue to
occur.
(63)
Internal
dose means that portion of the dose equivalent received from
radioactive material taken into the body.
(64)
Kilovolt (kV) means a
unit of electrical potential equal to 1000 volts. Kilovolt
peak (kVp) means the crest value in kilovolts of the potential
difference of a pulsating generator. When only one-half of the wave is used,
the value refers to the useful half of the wave.
(65)
Lead equivalent means
the thickness of lead affording the same attenuation, under specified
conditions, as the material in question.
(66)
Leakage radiation means
all radiation coming from within the source or tube housing except the useful
beam.
(67)
License
means a radioactive material license issued by the department in accordance
with the regulations adopted by the department. There are two types of
licenses: general and specific. A general license means a
license issued pursuant to the terms and conditions of Appendix 16-A, Table 6,
infra. General licenses are effective without the filing of an
application with or the issuance of a licensing document by the department. A
specific license shall mean a license evidenced by a licensing
document issued by the department to a licensee. A specific license also means
a similar license issued by the State Department or Labor, the New York City
Department of Health, the United States Nuclear Regulatory Commission or any
agreement state. Unless otherwise specified, the type of license referred to in
this Part will be a specific license.
(68)
Licensed material means
radioactive material received, possessed, used, transferred or disposed of
under a general or specific license issued by the department.
(69)
Licensee means any
person who is licensed by the department in accordance with these regulations
or one who possesses any radioactive material which is subject to the licensure
requirements of this Part.
(70)
Lost or missing licensed material means licensed material
whose location is unknown. This definition includes licensed material that has
been shipped but has not reached its planned destination and whose location
cannot be readily traced in the transportation system.
(71)
Member of the public
means any individual, except an individual who is performing assigned duties
for the licensee or registrant involving exposure to sources of
radiation.
(72)
Minor means an individual less than 18 years of age.
(73)
Monitoring means the
measurement or radiation, radioactive material concentrations, surface area
activities or quantities of radioactive material and the use of the results of
these measurements to evaluate potential exposures and doses. For purposes of
these regulations, radiation monitoring and radiation protection monitoring are
equivalent terms.
(74)
NARM means any naturally occurring or accelerator-produced
radioactive material. It does not include byproduct, source, or special nuclear
material.
(75)
Natural
radioactivity means radioactivity of naturally occurring
nuclides.
(76)
Nuclear
Regulatory Commission (NRC) means the U.S. Nuclear Regulatory
Commission or its duly authorized representatives.
(77)
Nonstochastic effect
means a health effect, the severity of which varies with the dose and for which
a threshold is believed to exist. Radiation-induced cataract formation is an
example of a nonstochastic effect. For purposes of these regulations, a
deterministic effect is an equivalent term.
(78)
Occupational dose means
the dose received by an individual in the course of employment in which the
individual's assigned duties involve exposure to sources of radiation, whether
in the possession or the licensee, registrant, or other person. Occupational
dose does not include doses received: from background radiation, as a patient
from medical practices, from voluntary participation in medical research
programs, or as a member of the public.
(79)
Operator means any
person conducting the business or activities carried on within the radiation
installation or having by law the administrative control of a radiation source
whether as owner, lessee, contractor, or otherwise.
(80)
Package means the
packaging, together with its radioactive contents as presented for
transport.
(81)
Particle
accelerator means any machine capable of accelerating electrons,
protons, deuterons, or other charged particles in a vacuum and of discharging
the resultant particulate or other radiation into a medium as energies usually
in excess of 1 MeV.
(82)
Person means any individual, corporation, partnership, firm,
association, trust, estate, public or private institution, group, agency,
political subdivision of this State, any other state or political subdivision
or agency thereof, and any legal successor, representative, agent, or agency of
the foregoing, but shall not include Federal government agencies.
(83)
Personnel monitoring
equipment (See individual monitoring devices).
(84)
Professional practice
means the practice of medicine, dentistry, podiatry, osteopathy or
chiropractic.
(85)
Professional practitioner means any person licensed or
otherwise authorized under the State Education Law to practice a proressional
practice.
(86)
Protective
apron means an apron made of radiation attenuating material(s), used
to reduce exposure to radiation.
(87)
Protective barrier
means a barrier of radiation absorbing material(s) used to attenuate the useful
beam and/or stray radiation to the degree required to assure compliance with
sections 16.6 and
16.7 of this Part.
(88)
Protective glove means
a glove made of radiation absorbing material(s) used to reduce radiation
exposure.
(89)
Public
dose means the dose received by a member of the public from exposure
to sources of radiation. It does not include occupational dose, dose received
from background radiation, dose received as a patient from medical practices.
or dose from voluntary participation in medical research programs.
(90) [Reserved]
(91)
Qualified expert means
an individual having the knowledge and training to measure ionizing radiation,
to evaluate safety techniques, and to advise regarding radiation protection
needs, for example, individuals certified in the appropriate field by the
American Board of Radiology or the American Board of Health Physics, or those
having equivalent training and experience. With reference to the calibration of
radiation therapy equipment, an individual having, in addition to the above
qualifications, training and experience in the clinical applications of
radiation physics to radiation therapy, for example, individuals certified in
Therapeutic Radiological Physics or X-Ray and Radium Physics by the American
Board of Radiology, or those having equivalent training and
experience.
(92)
Quality
factor (Q) means the modifying factor, that is used to derive dose
equivalent from absorbed dose.
(i) As used in
these regulations, the quality factors for converting absorbed dose to dose
equivalent are shown in Table I.
Table I
Quality Factors and Absorbed Dose
Equivalents
Type of radiation |
Quality factor (Q) |
Absorbed dose equal to a unit dose equivalent
a |
X, gamma, or beta radiation and high-speed
electrons |
1 |
1 |
Alpha particles, multiple-charged particles, fission
fragments and heavy particles of unknown charge |
20 |
0.05 |
Neutrons or unknown energy |
10 |
0.1 |
High-energy protons |
10 |
0.1 |
a Absorbed dose in rad equal to
1 rem or the absorbed dose in gray equal to1 Sv.
(ii) If it is more convenient to measure the
neutron fluence rate than to determine the neutron dose equivalent rate in
sievert per hour or rem per hour, as provided in Table I, 0.01 Sv (1 rem) of
neutron radiation of unknown energies may, for purposes of these regulations,
be assumed to result from a total fluence or 25 million neutrons per square
centimeter incident upon the body. If sufficient information exists to estimate
the approximate energy distribution or the neutrons, the licensee or registrant
may use the fluence rate per unit dose equivalent or the appropriate Q value
from Table II to convert a measured tissue dose in gray or rad to dose
equivalent in sievert or rem.
Table II
Mean Quality Factors, Q, and Fluence per Unit Dose
Equivalent for Monoenergetic Neutrons
Neutron energy (MeV) |
Quality factor
a |
Fluence per unit dose equivalent
b |
Fluence per unit dose equivalent
b |
(thermal) 2.5 × 108 |
2 |
980 × 106 |
980 × 108 |
1 × 107 |
2 |
980 × 106 |
980 × 108 |
1 × 106 |
2 |
810 × 106 |
810 × 108 |
1 × 105 |
2 |
810 × 106 |
810 × 108 |
1 × 104 |
2 |
840 × 106 |
840 × 108 |
1 × 103 |
2 |
980 × 106 |
980 × 108 |
1 × 102 |
2.5 |
1010 × 106 |
1010 × 108 |
1 × 101 |
7.5 |
170 × 106 |
170 × 108 |
5 × 101 |
11 |
39 × 106 |
39 × 108 |
1 |
11 |
27 × 106 |
27 × 188 |
2.5 |
9 |
29 × 106 |
29 × 108 |
5 |
8 |
23 × 106 |
23 × 108 |
7 |
7 |
24 × 106 |
24 × 108 |
10 |
6.5 |
24 × 106 |
24 × 108 |
14 |
7.5 |
17 × 106 |
17 × 108 |
20 |
8 |
16 × 106 |
16 × 108 |
40 |
7 |
14 × 106 |
14 × 108 |
60 |
5.5 |
16 × 106 |
16 × 108 |
1 × 102 |
4 |
20 × 106 |
20 × 108 |
2 × 102 |
3.5 |
19 × 106 |
19 × 108 |
3 × 102 |
3.5 |
16 × 106 |
16 × 108 |
4 × 102 |
3.5 |
14 × 106 |
14 × 108 |
a Value of quality factor (Q) at
the point where the dose equivalent is maximum in a 30-cm diameter cylinder
tissue-equivalent phantom.
b Monoenergetic neutrons
incident normally on a 30-cm diameter cylinder tissue-equivalent
phantom.
(93)
Quarter (See Calendar quarter).
(94)
Rad means the special
unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg/gram or
0.01 jouie/kilogram (0.01 gray). One millirad equals 0.001 rad.
(95)
Radiation means alpha
particles, beta particles, gamma rays, X-rays, neutrons, high-speed electrons,
high-speed protons, and other particles capable of producing ions. For purposes
of these regulations, ionizing radiation is an equivalent term. Radiation, as
used in these regulations, does not include non-ionizing radiation, such as
radiowaves or microwaves, visible, infrared, or ultraviolet light.
(96)
Radiation area means
any area, accessible to individuals, in which radiation levels could result in
an individual receiving a dose equivalent in excess or 0.05 mSv (0.005 rem) in
1 hour at 30 centimeters from the source of radiation or from any surface that
the radiation penetrates.
(97)
Radiation equipment means any equipment or device which can
emit radiation by virtue of the application thereto of high voltage.
(98)
Radiation installation
means place, facility or mobile unit where radiation equipment, in operable
condition or intended to be used, is located or used, or where radioactive
material is transferred, received, possessed or used including generally a
hospital; medical, dental, chiropractic, osteopathic, podiatric, or
veterinarian institution, clinic or office; educational institution;
commercial, private or research laboratory performing diagnostic procedures or
handling equipment or material for medical use; or any trucking, storage,
messenger or delivery service establishment. Radiation installation shall
include, whether or not it is specifically stated above, any place, facility or
mobile unit where radiation is applied intentionally to a human. The limits of
the radiation installation area shall be as designated by the
operator.
(99)
Radiation
safety officer shall mean an individual who, under the authorization
of the operator or a radiation installation, administers a radiation protection
program in accordance with section
16.5 of this Part and who is
qualified by training and experience in radiological health to evaluate the
radiation hazards of such installation and administer such radiation protection
program.
(i) For human use radiation equipment
installations, the radiation safety officer (RSO) shall be:
(a) a professional practitioner as defined in
paragraph (85) of this subdivision, practicing within his/her professional
practice as defined in paragraph (84) of this subdivision; or
(b) a physicist certified by the American
Board of Health Physics or the American Board of Radiology in a branch of
physics related to the type of use of radiation sources in the installation,
or, an individual with equivalent training and experience.
(ii) For non-human use radiation equipment
installations, the radiation safety officer shall be:
(a) a veterinarian for veterinary
installations; or
(b) a physicist
certified by the American Board or Health Physics, the American Board of
Radiology, or, an individual with equivalent training and experience;
or
(c) a researcher determined by
the institution as qualified by training and experience for installations using
only X-ray diffraction and fluorescence analysis equipment.
(iii) For licensed radioactive
materials installations, the radiation safety officer shall be:
(a) an authorized user named on the
radioactive materials license issued by this department; or
(b) a physicist certified by the American
Board of Health Physics or the American Board of Radiology in a branch of
physics related to the type of use of radioactive material in the installation,
or, an individual with equivaient training and experience.
(100)
Radiation
source means any radioactive material or any radiation
equipment.
(101)
Radioactive material means any solid, liquid, or gas which
emits radiation spontaneously.
(102)
Radioactivity means
the transformation of unstable atomic nuclei by the emission of
radiation.
(103)
Radiobioassay (See Bioassay).
(104)
Reference man means a
hypothetical aggregation of human physical and physiological characteristics
determined by international consensus. These characteristics may be used by
researchers and public health workers to standardize results of experiments and
to relate biological insult to a common base.
(105)
Registrant means any
person who is registered with the department or is legally obligated to
register with the department pursuant to these regulations.
(106)
Registration means
registration with the department in accordance with these
regulations.
(107)
Rem means the special unit of any of the quantities expressed
as dose equivaient. The dose equivalent in rem is equal to the absorbed dose in
rad multiplied by the quality factor (one rem = 0.01 sievert).
(108)
Research and
development means:
(i) theoretical
analysis, exploration, or experimentation; or
(ii) the extension of investigative findings
and theories of a scientific or technical nature into practical application for
experimental and demonstration purposes, including the experimental production
and testing of models, devices, equipment, materials, and processes. Research
and development does not include the internal or external administration of
radiation or radioactive material to human beings.
(109)
Respiratory protective
equipment means an apparatus, such as a respirator, used to reduce an
individual's intake of airborne radioactive material.
(110)
Restricted area means
any area, access to which is limited by the licensee or registrant for the
purpose of protecting individuals against undue risks from exposure to sources
of radiation. A restricted area does not include areas used as residential
quarters, but separate rooms in a residential building may be set apart as a
restricted area.
(111)
Roentgen means the special unit or exposure. One roentgen (R)
equals 2.58 * 104 coulombs/kilogram of air (See
Exposure).
(112)
Sanitary
sewerage means a system of public sewers for carrying off waste and
refuse, but excluding sewage treatment facilities, septic tanks, and leach
fields owned or operated by the licensee or registrant.
(113)
Scattered radiation
means radiation whose direction has been altered during passage through matter.
(It may have been modified also by a decrease in energy.)
(114)
Sealed source means
radioactive material that is permanently bonded or fixed in a capsule or matrix
designed to prevent release and dispersal of the radioactive material under the
most severe conditions which are likely to be encountered in normal use and
handling.
(115)
Shallow
dose equivalent (H5), which applies to the
external exposure of the skin or an extremity, means the dose equivalent at a
tissue depth of 0.007 centimeter (7 mg/cm 2)
averaged over an area of one square centimeter.
(116)
Shutter means:
(i) in beam therapy equipment, an adjustable
device, generally of lead, fixed to the X- or gamma-ray source housing to
intercept or collimate the useful beam; or
(ii) in diagnostic equipment, an adjustable
device used to collimate the useful beam.
(117)
SI means an
abbreviation of the International System of Units.
(118)
Sievert means the SI
unit of any of the quantities expressed as dose equivalent. The dose equivalent
in sievert is equal to the absorbed dose in gray multiplied by the quality
factor (one Sv = 100 rem).
(119)
Site boundary means that line beyond which the land or
property is not owned, leased, or otherwise controlled by the licensee or
registrant.
(120)
Source
material means:
(i) uranium or
thorium, or any combination thereof, in any physical or chemical form;
or
(ii) ores that contain by weight
one-twentieth of one percent (0.05 percent) or more of uranium, thorium, or any
combination of uranium and thorium. Source material does not include special
nuclear material.
(121)
Source of radiation means any radioactive material or any
device or equipment emitting, or capable of producing, radiation.
(122)
Source-skin distance
(source-surface distance) means the distance measured along the
central ray from the center of the front surface of the source (X-ray focal
spot or sealed radioactive source) to the surface of the irradiated
object.
(123)
Special form
radioactive material means radioactive material which satisfies the
following conditions:
(i) it is either a
single solid piece or is contained in a sealed capsule that can be opened only
by destroying the capsule;
(ii) the
piece or capsule has at least one dimension not less than five millimeters
(0.197 inch); and
(iii) it
satisfies the additional requirements specified in section
71.4, special form radioactive
material, of 10 CFR
71 (see section
16.200 of this Part).
(124)
Special nuclear
material means:
(i) plutonium,
uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any
other material that the U.S. Nuclear Regulatory Commission, pursuant to the
provisions of section 51 of the Atomic Energy Act of 1954, as amended,
determines to be special nuclear material, but does not include source
material; or
(ii) any material
artificially enriched by any of the foregoing but does not include source
material.
(125)
Special nuclear material in quantities not sufficient to form a
critical mass means uranium enriched in the isotope U-235 in
quantities not exceeding 350 grams of contained U-235; uranium-233 in
quantities not exceeding 200 grams; plutonium in quantities not exceeding 200
grams; or any combination or them in accordance with the following formula: For
each kind of special nuclear material, determine the ratio between the quantity
of that special nuclear material and the quantity specified above for the same
kind of special nuclear material. The sum of such ratios for all of the kinds
of special nuclear material in combination shall not exceed one. For example,
the following quantities in combination would not exceed the limitation and are
within the formula:
175 (grams contained
U-235)/350+ 50 (grams
U-233)/200+ 50 (grams
Pu)/200 = 1
(126)
State means the State
of New York, unless the context of this Part clearly indicates that a different
meaning is intended.
(127)
Stochastic effect means a health effect that occurs randomly
and for which the probability of the effect occurring, rather than its
severity, is assumed to be a function of dose without threshold. Hereditary
effects and cancer incidence are examples of stochastic effects. For purposes
of these regulations, probabilistic effect is an equivalent term.
(128)
Stray radiation means
the sum of leakage and scattered radiation.
(129)
Supervision as used in
radioactive materials licenses means the training of persons in the use of
radioactive materials in other than medical procedures. Such training must
include at least 30 hours of instruction in the principles and practices of
radiation protection, radioactivity measurement standardization and monitoring
techniques and instruments, mathematics and calculations basic to the use and
measurement of radioactivity, and biological effects of radiation.
(130)
Survey means an
evaluation of the radiological conditions and potential hazards incident to the
production, use, transfer, release, disposal, or presence of sources of
radiation. When appropriate, such evaluation includes, but is not limited to,
tests, physical examinations, and measurements of levels of radiation or
concentrations of radioactive material present.
(131)
Therapeutic type protective
tube housing means:
(i) for X-ray
therapy equipment not capable of operating at 500 kVp or above, an X-ray tube
housing so constructed that the leakage radiation at a distance of one meter
from the source does not exceed one roentgen in an hour when the tube is
operated at its maximum rated continuous current for the maximum rated tube
potential; or
(ii) for X-ray
therapy equipment capable of operation at 500 kVp or above, an X-ray tube
housing so constructed that leakage radiation at a distance of one meter from
the source does not exceed 0.1 percent of the useful beam dose rate at one
meter from the source for any of its operating conditions.
(132)
These regulations mean
all parts of Part 16 of the State Sanitary Code.
(133)
Total effective dose
equivalent (TEDE) means the sum of the deep dose equivalent for
external exposures and the committed effective dose equivalent for internal
exposures.
(134)
[Reserved]
(135)
U.S. Department of Energy means the Department of Energy
established by Public Law
95-91, August 4, 1977, 91 Stat. 565,
42 U.S.C.
7101
et seq., to the extent
that the department exercises functions formerly vested in the U.S. Atomic
Energy Commission, its chairman, members, officers and components and
transferred to the U.S. Energy Research and Development Administration and to
the administrator thereof pursuant to sections 104(b), (c) and (d) of the
Energy Reorganization Act of 1974 (Public Law 93-438, October 11,
1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January
19, 1975) and transferred to the Secretary of Energy pursuant to section 301(a)
of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977,
91 Stat. 565 at 577-578, 42
U.S.C. 7151, effective October 1,
1977.)
(136)
Unrefined and
unprocessed ore means ore in its natural form prior to any processing,
such as grinding, roasting, beneficiating, or refining.
(137)
Use as used in
radioactive materials licenses means to employ or apply radioactive materials
for the licensed purpose. It shall include instruction of, and responsibility
for, technical and support staff members. It does not include training others
in the techniques of use of radioactive materials for the purpose of qualifying
for licensure. In licenses authorizing human use of radioactive materials
use will also include:
(i)
ordering or directing the administration of radiation of radioactive materials
to humans, including the method or route of administration;
(ii) actual use of, or direction of
technologists or other paramedical personnel in the use of, radioactive
material;
(iii) interpretation of
results of diagnostic procedures; and
(iv) regular view or the progress of patients
receiving therapy and modification of the originally prescribed dose as
warranted by the patient's reaction to radiation therapy.
(138)
Useful beam means the
radiation which passes through the source or tube-housing port and the aperture
of the collimating device when the exposure switch or timer is
activated.
(139)
Very high
radiation area means an area, accessible to individuals, in which
radiation levels could result in an individual receiving an absorbed dose in
excess of five Gy (500 rad) in one hour at one meter from a source of radiation
or from any surface that the radiation
penetrates.3
(140)
Waste handling
licensees mean persons licensed to receive and store radioactive
wastes prior to disposal and/or persons licensed to dispose of radioactive
wastes.
(141)
Week
means seven consecutive days starting on Sunday.
(142)
Weighting factor
WT for an organ or tissue (T) means the proportion or
the risk of stochastic effects resulting from irradiation or that organ or
tissue to the total risk or stochastic effects when the whole body is
irradiated uniformly. For calculating the effective dose equivalent, the values
of WT are:
Organ Dose Weighting Factors
Organ or
tissue |
WT |
Gonads |
0.25 |
Breast |
0.15 |
Red Bone Marrow |
0.12 |
Lung |
0.12 |
Thyroid |
0.03 |
Bone Surfaces |
0.03 |
Remainder |
0.30 a |
Whole Body |
1.00 b |
a 0.30 results from 0.06 for
each of five "remainder" organs, excluding the skin and the lens of the eye,
that receive the highest doses.
b For purposes of weighting the
external whole body dose, for adding it to the internal dose, a single
weighting factor, W T = 1.0, has been specified. The use
of other weighting factors for external exposure will be approved on a
case-by-case basis until such time as specific guidance is issued.
(143)
Whole body
means, for purposes of external exposure, head, trunk (including male gonads),
arms above the elbow, or legs above the knee.
(144)
Worker means an
individual engaged in work under a license or registration issued by the
department and controlled by a licensee or registrant, but does not include the
licensee or registrant.
(145)
Working level (WL) means any combination of short-lived radon
daughters in 1 liter of air that will result in the ultimate emission of 1.3 *
105 MeV of potential alpha particle energy. The
short-lived radon daughters, are - for radon-222: polonium-218, lead-214,
bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212,
bismuth-212, and polonium-212.
(146)
Working level month
(WLM) means an exposure to one working level for 170 hours -2,000 working hours
per year divided by 12 months per year is approximately equal to 170 hours per
month.
(147)
Year
means the period of time beginning in January used to determine compliance with
the provisions of these regulations. The licensee or registrant may change the
starting date of the year used to determine compliance by the licensee or
registrant provided that the change is made at the beginning of the year and
that no day is omitted or duplicated in consecutive years.
Footnotes
3 At very high doses received at high dose rates, units of
absorbed dose, gray and rad, are appropriate, rather than units of dose
equivalent, sievert and rem.