CHAPTER He-P
4000 NEW HAMPSHIRE RULES FOR THE CONTROL
OF RADIATION
Statutory
Authority RSA 125-F:5,V; RSA 125-F:7; RSA 125-F:8; and RSA 125-F:8-b
PART
He-P 4001 SCOPE, EXEMPTIONS, AND GENERAL
PROVISIONS
He-P 4001.01 Scope.
Except as otherwise specifically provided, these rules shall apply to
all persons who receive, possess, use, transfer, own, or acquire any source of
radiation provided, however, that nothing in these rules shall apply to any
person to the extent such person is subject to regulation by the U.S. Nuclear
Regulatory Commission, (NRC). Regulation
by the department of health and human services/radiological health section,
(DHHS/RHS) of source material, byproduct material, and special nuclear material
in quantities not sufficient to form a critical mass is subject to the
provisions of the agreement between the Agreement State, New Hampshire, and the
NRC as of May 16, 1966, and to 10 CFR (Code of Federal Regulations) Part 150.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.02 Exemptions.
(a) Pursuant to RSA 125-F:7, III, the following
persons shall be exempt from the requirements of He-P 4000 as follows:
(1) Prime contractors performing work for the
U.S. Department of Energy at U.S. Government owned or controlled sites shall be
exempt from these rules to the extent that such contractor or subcontractor
under his contract receives, possesses, uses, transfers, or acquires sources of
radiation including the transportation of sources of radiation to or from such
sites and the performance of contract services during temporary interruptions
of such transportation;
(2) Prime contractors of the U.S. Department of
Energy shall be exempt from these rules to the extent that such contractor or
subcontractor under his contract receives, possesses, uses, transfers, or
acquires sources of radiation to perform research in, or development,
manufacture, storage, testing, or transportation of, atomic weapons or
components thereof;
(3) Prime contractors of the U.S. Department of
Energy shall be exempt from these rules to the extent that such contractor or
subcontractor under his contract receives, possesses, uses, transfers, or
acquires sources of radiation to use or operate nuclear reactors or other
nuclear devices in a United States government owned vehicle or vessel;
(4) Any other prime contractor or subcontractor
of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission
shall be exempt from these rules to the extent that such contractor or
subcontractor under his contract receives, possesses, uses, transfers, or
acquires sources of radiation; and
(5) Any other prime contractor or subcontractor
of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission
shall be exempt from these rules when the state and the U.S. Nuclear Regulatory
Commission jointly determine:
a. That the exemption of the prime contractor or
subcontractor is authorized by law; and
b. That, under the terms of the contract or
subcontract, there is adequate assurance that the work there under can be
accomplished without undue risk to the public health and safety.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.03 Records.
(a) Each licensee and registrant shall maintain
records pursuant to He‑P 4000 showing the receipt, transfer, and disposal
of all sources of radiation. Each licensee and registrant shall also comply
with the records requirements in He-P 4021.
(b) Records of receipt, transfer, and disposal of
sources of radiation shall include as a minimum, the following:
(1) A unique identification of each source of
radiation including:
a. Manufacturer’s name;
b. Isotope, if a radioactive source;
c. Activity, if a radioactive source;
d. Source model number; and
e. Source serial number;
(2) The date of receipt, transfer, or disposal of
each source of radiation;
(3) For the person transferring the source of
radiation, pertinent information including:
a. The name of the transferee;
b. The number of the transferee’s radioactive
material license or registration certificate authorizing possession of the
source of radiation; and
c. The regulatory agency issuing the license or
registration to the transferee; and
(4) For the person receiving the source of
radiation, pertinent information including:
a. The name of the transferor;
b. The number of
the transferor’s radioactive material license or registration certificate
authorizing possession of the source of radiation; and
c. The regulatory agency issuing the license or
registration to the transferor.
(c) Records required by this chapter shall be
retained by the licensee or registrant indefinitely or as per additional record
requirements specified elsewhere in these rules.
(d) All records required by this chapter shall be
accurate and factual.
(e) Records required by this chapter shall be
considered valid only if stamped, initialed, or signed and dated by authorized
personnel or otherwise authenticated.
(f) Each record required by this chapter shall be
legible throughout the retention period as specified in He-P 4001.03(c).
(g) Each record required by this chapter shall be
the original or a reproduced copy or a microform or stored in electronic media,
provided that:
(1) The copy is authenticated by authorized
personnel; and
(2) The microform or electronic media is
authenticated by authorized personnel and is capable of
producing clear, legible, accurate, and complete copies of records
throughout the required retention period.
(h) The licensee shall maintain adequate
safeguards against tampering with and loss of records.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES:
2-2-07; ss by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.04 Inspections.
(a) Each licensee and registrant shall allow the
department of health and human services/ radiological health section (DHHS/RHS)
at any time during the licensee’s or registrant’s regular business hours to
inspect sources of radiation and the premises and facilities wherein such
sources of radiation are used or stored.
(b) Each
licensee and registrant shall make available to DHHS/RHS for inspection,
records maintained pursuant to the rules in this chapter.
He-P
4001.05 Tests.
(a) Each licensee and registrant shall perform,
pursuant to instructions from DHHS/RHS, or shall permit DHHS/RHS to perform,
tests which will assist DHHS/RHS in determining the licensee’s or registrant’s
compliance with these rules, including tests of:
(1) Sources of radiation;
(2) Facilities where sources of radiation are utilized
or stored;
(3) Radiation detection and
monitoring instruments; and
(4) Other equipment and devices used in connection with
the utilization or storage of licensed or registered sources of radiation.
(b) The licensee in possession
of any sealed source shall ensure that:
(1) Each sealed source, except as specified in He‑P
4001.05(c), is tested for leakage or contamination and the test results are
received before the sealed source is put into use unless the licensee has a
certificate from the transferor indicating that the sealed source was tested
within 6 months before transfer to the licensee;
(2) Each sealed source that is not designed to emit
alpha particles is tested for leakage or contamination at intervals not to
exceed 12 months, except those as specified in He-P 4034.10 and
He-P 4035.21;
(3) Each sealed source that is designed to emit alpha
particles is tested for leakage or contamination at intervals not to exceed
3 months;
(4) Each sealed source that is required to be tested
for leakage or contamination, that might have been damaged or might be leaking,
is tested for leakage and contamination before further use;
(5) Tests for leakage for all sealed sources, except
brachytherapy sources manufactured to contain radium, are capable of detecting
the presence of 185 Bq (0.005 Ci)
of radioactive material on a test sample which is taken from the sealed source
or taken from the surfaces of the container in which the sealed source is
stored or mounted and at the nearest accessible point to the sealed source
where contamination might accumulate, and for a sealed source contained in a
device, test samples are obtained when the source is in the “off” position;
(6) Tests for leakage of sealed
sources and Brachytherapy sources and their associated requirements are
specified in He-P 4035.21;
(7) Tests for contamination from radium daughters are
taken on the interior surface of brachytherapy source storage containers and are capable of detecting the presence of 185 Bq (0.005 Ci) of a radium daughter which
has a half-life greater than 4 days; and
(8) Tests for leakage or contamination are performed
using a leak test kit or method approved by DHHS/RHS.
(c) A licensee shall not be required to perform tests
for leakage or contamination on the following sealed sources:
(1) Sealed sources containing only radioactive material
with a half-life of less than 30 days;
(2) Sealed sources containing only radioactive material
as a gas;
(3) Sealed sources containing 3.7 MBq
(100 Ci) or less of beta or photon-emitting material or 370 kBq (10 µCi) or less of alpha-emitting material;
(4) Sealed sources containing only hydrogen-3;
(5) Seeds of iridium-192 encased in nylon ribbon; and
(6) Sealed sources, except teletherapy and
brachytherapy sources, which are stored, not being used and
identified as in storage.
(d) The licensee shall, however, test each such sealed
source in He-P 4001.05(c)(6) for leakage or contamination and receive the test
results:
(1) At intervals no greater than 3 years; and
(2) Before any use or transfer unless the source has
been tested for leakage or contamination within 6 months before the date of use
or transfer.
(e) Tests for leakage or contamination from sealed
sources shall be performed by persons specifically licensed by DHHS/RHS,
an agreement state, a licensing state, or the U.S. Nuclear
Regulatory Commission to perform such services.
(f) Test results shall be kept in units of Becquerel or
microcurie and maintained for inspection by DHHS/RHS for 5 years from date of
test.
(g) The following shall be considered evidence that a
sealed source is leaking:
(1) The presence of 185 Bq (0.005 µCi)
or more of removable contamination on any test sample;
(2) Leakage of 37 Bq (0.001 µCi)
of radon-222 per 24 hours for brachytherapy sources manufactured to contain
radium; or
(3) The presence of removable contamination resulting
from the decay of 185 Bq (0.005 µCi)
or more of radium.
(h) The licensee shall immediately withdraw a leaking
sealed source from use and shall take action in
accordance with He-P 4003.05(i) to prevent the spread
of contamination.
(i) If a sealed source is
leaking, the licensee shall:
(1) Decontaminate the facility and source in accordance
with He-P 4021.20, and dispose of the leaking source in accordance with He-P
4023; or
(2) Decontaminate the facility and source in accordance
with He-P 4021.20, and have the source repaired by a person specifically
licensed to perform this service.
(j) Reports of test results for leaking or contaminated
sealed sources shall be made pursuant to He-P 4021.19.
Source.
#5903, eff 2-1-95; ss by #6827, eff 8-6-98; ss by
#8488, eff 11-18-05; ss by #8808, eff 1-24-07; ss by #10805, eff 3-28-15; ss by
#13599, eff 3-24-23
He-P 4001.05 Tests.
(a) Each licensee and registrant shall perform,
shall perform pursuant to instructions from DHHS/RHS, or shall permit DHHS/RHS
to perform, tests which will assist DHHS/RHS in determining the licensee’s or
registrant’s compliance with these rules, including tests of:
(1) Sources of radiation;
(2) Facilities where sources of radiation are utilized
or stored;
(3) Radiation detection and monitoring
instruments;
(4) Other equipment and devices used in
connection with the utilization or storage of licensed or registered sources of
radiation.
(b) The licensee in possession of any sealed
source shall assure that:
(1) Each sealed source, except as specified in He‑P4001.05(c),
is tested for leakage or contamination and the test results are received before
the sealed source is put into use unless the licensee has a certificate from
the transferor indicating that the sealed source was tested within 6 months
before transfer to the licensee;
(2) Each sealed source that is not designed to
emit alpha particles is tested for leakage or contamination at intervals not to
exceed 12 months, except those as specified in He-P 4034.10 and He-P 4035.21;
(3) Each sealed
source that is designed to emit alpha particles is tested for leakage or
contamination at intervals not to exceed 3 months;
(4) Each sealed source that is required to be
tested for leakage or contamination, that might have been damaged or might be
leaking, is tested for leakage and contamination before further use;
(5) Tests for leakage for all sealed sources,
except brachytherapy sources manufactured to contain radium, are capable of
detecting the presence of 185 Bq (0.005 mCi) of radioactive
material on a test sample which is taken from the sealed source or taken from
the surfaces of the container in which the sealed source is stored or mounted
and at the nearest accessible point to the sealed source where contamination
might accumulate, and for a sealed source contained in a device, test samples
are obtained when the source is in the “off” position;
(6) The test for leakage for brachytherapy
sources manufactured to contain radium is capable of
detecting an absolute leakage rate of 37 Bq
(0.001 mCi)
of radon-222 in a 24 hour period when the collection efficiency for radon-222
and its daughters has been determined with respect to collection method, volume
and time;
(7) Tests for contamination from radium daughters
are taken on the interior surface of brachytherapy source storage containers
and are capable of detecting the presence of 185 Bq (0.005 mCi) of a radium daughter which has
a half-life greater than 4 days; and
(8) Tests for leakage or contamination are
performed using a leak test kit or method approved by DHHS/RHS.
(c) A licensee shall not be required to perform
tests for leakage or contamination on the following sealed sources:
(1) Sealed sources containing only radioactive
material with a half-life of less than 30 days;
(2) Sealed sources containing only radioactive
material as a gas;
(3) Sealed sources containing 3.7 MBq (100 mCi) or less of
beta or photon-emitting material or 370 kBq (10 µCi)
or less of alpha-emitting material;
(4) Sealed sources containing only hydrogen-3;
(5) Seeds of iridium-192 encased in nylon ribbon;
and
(6) Sealed sources, except teletherapy and
brachytherapy sources, which are stored, not being used
and identified as in storage.
(d) The licensee shall, however, test each such
sealed source in He-P 4001.05(c)(6) for leakage or contamination and receive
the test results:
(1) At intervals no greater than 3 years; and
(2) Before any use or transfer unless the source
has been tested for leakage or contamination within 6 months before the date of
use or transfer.
(e) Tests for leakage or contamination from
sealed sources shall be performed by persons specifically licensed by DHHS/RHS,
an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory
Commission to perform such services.
(f) Test results shall be kept in units of
Becquerel or microcurie and maintained for inspection by DHHS/RHS for 5 years
from date of test.
(g) The following shall be considered evidence that
a sealed source is leaking:
(1) The presence of 185 Bq
(0.005 µCi) or more of removable contamination on any test sample;
(2) Leakage of 37 Bq (0.001 µCi) of radon-222 per 24 hours for
brachytherapy sources manufactured to contain radium; or
(3) The presence of removable contamination
resulting from the decay of 185 Bq
(0.005 µCi) or more of radium.
(h) The licensee shall immediately withdraw a
leaking sealed source from use and shall take action
in accordance with He-P 4003.06(i) to prevent the
spread of contamination.
(i) If a sealed
source is leaking, the licensee shall:
(1) Decontaminate the facility and source in
accordance with He-P 4021.20, and dispose of the leaking source in accordance
with He-P 4023; or
(2) Decontaminate the facility and source in
accordance with He-P 4021.20, and have the source repaired by a person
specifically licensed to perform this service.
(j) Reports of test results for leaking or
contaminated sealed sources shall be made pursuant to He-P 4021.19.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; amd by #8488, eff 11-18-05; amd by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by
#8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.06 Prohibited Uses.
(a) A hand-held fluoroscopic screen shall not be
used with x‑ray equipment unless it has first been listed in the
Conference of Radiation Control Program Directors (CRCPD) Registry of Sealed
Source and Devices or accepted for certification by the U.S. Food and Drug
Administration, Center for Devices and Radiological Health.
(b) A shoe-fitting fluoroscopic device shall
never be used for any purpose.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.07 Deliberate Misconduct.
(a) Any licensee, certificate of registration
holder, applicant for a license or certificate of registration, employee of a
licensee, certificate of registration holder or applicant; or any contractor,
including a supplier or consultant, subcontractor, employee of a contractor or
subcontractor of any licensee or certificate of registration holder or
applicant for a license or certificate of registration, who knowingly provides
to any licensee, applicant, certificate holder, contractor, or subcontractor,
any components, equipment, materials, or other goods or services that relate to
a licensee’s, certificate holder’s or applicant’s activities in this part,
shall not:
(1) Engage in deliberate
misconduct that causes or would have caused, if not detected, a licensee,
certificate of registration holder, or applicant to be in violation of any
rule, regulation, or order; or any term, condition, or limitation of any
license issued by DHHS/RHS; or
(2) Deliberately submit to DHHS/RHS, a licensee,
certificate of registration holder, an applicant, or a licensee’s, certificate
holder’s or applicant’s, contractor or subcontractor, information that the
person submitting the information knows to be incomplete or inaccurate in some
respect material to DHHS/RHS.
(b) A person who violates paragraph He-P
4001.07(a)(1) or (a)(2) shall be subject to enforcement action in accordance
with RSA 125-F:21 and RSA 125-F:22.
(c) For the purposes of He-P 4001.07(a)(1),
“deliberate misconduct” by a person means an intentional act or omission that
the person knows:
(1) Would cause a licensee, certificate of
registration holder or applicant to be in violation of any rule, regulation, or
order; or any term, condition, or limitation, of any license issued by
DHHS/RHS; or
(2) Constitutes a violation of a requirement,
procedure, instruction, contract, purchase order, or policy of a licensee,
certificate of registration holder, applicant, contractor, or subcontractor.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4001.08 Communications.
All communications and reports concerning these rules, and applications, or
electronic submissions filed thereunder, shall be addressed to:
Radiological
Health Section
Division of Public
Health Services
NH Department of
Health and Human Services
29 Hazen Drive
Concord, New
Hampshire 03301
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss and moved by #8488, eff 11-18-05 (from He-P
4001.07); ss by #8808, eff 1-24-07; ss by #10805, eff 3-28-15; ss by #13120,
eff 10-20-20
He-P 4001.09 Units of
Exposure and Dose.
(a) As used in these rules, the unit of exposure shall
be the coulomb per kilogram (C/kg) of air.
(b) One roentgen shall be equal to 2.58 ×10-4 coulomb
per kilogram of air.
(c) As used in these rules, the
units of dose shall be:
(1) Gray (Gy)
as defined in He-P 4003.01;
(2) Rad as defined in He-P
4003.01;
(3) Rem as defined in He-P
4003.01; or
(4) Sievert as defined in He-P
4003.01.
(d) As used in these rules, the quality factors for
converting absorbed dose to dose equivalent shall be as in Table 4001.1:
Table 4001.1 Quality Factors and Absorbed
Dose Equivalencies
Type of
Radiation |
Quality Factor (Q) |
Absorbed Dose Equal to a Unit Dose Equivalent |
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 of
unknown energy |
10 |
0.1 |
High-energy
protons |
10 |
0.1 |
(e) 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 He-P 4001.09(f), 0.01 Sv (1 rem) of neutron radiation of unknown
energies may, for purposes of these rules, be assumed to result from a total
fluence of 25 million neutrons per square centimeter incident upon the body.
(f) If sufficient information exists to estimate the
approximate energy distribution of the neutrons, the licensee or registrant may
use the fluence rate per unit dose equivalent or the appropriate Q value
from Table 4001.2 to convert a measured tissue dose in gray or rad to dose
equivalent in sievert or rem.
(g) As used in these rules, the mean quality factors,
Q, and fluence per unit dose equivalent for monoenergetic neutrons shall be as
shown in Table 4001.2 below:
Table 4001.2 Mean Quality Factors, Q, and
Fluence Per Unit Dose Equivalent
for Monoenergetic Neutrons
Neutron Energy (MeV) |
Quality Factor (Q) |
Fluence per Unit Dose Equivalent |
Fluence per Unit Dose Equivalent |
(thermal) 2.5 × 10-8 |
2 |
980 × 106 |
980 × 108 |
1 × 10-7 |
2 |
980 × 106 |
980 × 108 |
1 × 10-6 |
2 |
810 × 106 |
810 × 108 |
1 × 10-5 |
2 |
810 × 106 |
810 × 108 |
1 × 10-4 |
2 |
840 × 106 |
840 × 108 |
1 × 10-3 |
2 |
980 × 106 |
980 × 108 |
1 × 10-2 |
2.5 |
1010 × 106 |
1010 × 108 |
1 × 10-1 |
7.5 |
170 × 106 |
170 × 108 |
5 × 10-1 |
11 |
39 × 106 |
39 × 108 |
1 |
11 |
27 × 106 |
27 × 108 |
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 |
100 |
4 |
20 × 106 |
20 × 108 |
200 |
3.5 |
19 × 106 |
19 × 108 |
300 |
3.5 |
16 × 106 |
16 × 108 |
400 |
3.5 |
14 × 106 |
14 × 108 |
(h) Value of quality factor (Q) in Table 4001.2 shall
be the point where the dose equivalent is maximum in a 30-centimeter diameter
cylinder tissue-equivalent phantom.
(i) Fluence per unit dose
equivalent in Table 4001.2 shall be monoenergetic neutrons incident normally on
a 30-centimeter diameter cylinder tissue-equivalent phantom.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98 (renumbered by #8488, from He-P 4001.08); ss by #8692,
INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10805,
eff 3-28-15; ss by #13599, eff 3-24-23
He-P 4001.10 Units of Activity. Activity shall be expressed in the SI unit of
Becquerel (Bq) or in the special unit of curie (Ci),
or their multiples, and submultiples, or disintegrations (transformations) per
unit of time.
Source. #6827, eff 8-6-98
(renumbered by #8488, from He-P 4001.09); ss by #8692, INTERIM, eff 7-27-06,
EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.11 Determination of Year.
(a) Year shall be the period of
time beginning in January used to determine compliance with the
provisions of these rules.
(b) 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.
Source. #6827, eff 8-6-98
(renumbered by #8488, from He-P 4001.10); ss by #8692, INTERIM, eff 7-27-06,
EXPIRES: 2-2-07; ss by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4001.12 Additional Requirements.
(a) DHHS/RHS shall, by rule, regulation, or
order, written pursuant to RSA 125-F:5, F:7, F:10, or F:17 and RSA 541-A,
impose upon any licensee or registrant such requirements in addition to those
established in this chapter as DHHS/RHS deems appropriate or necessary to
minimize danger to public health and safety or property.
(b) Any person shall report any source of
radiation, as defined in RSA 125-F:3 XX, that the person:
(1) Finds or detects, and which is not under the
physical or administrative control of a licensee or registrant, provided it is
not excluded, exempted or otherwise authorized under
the provisions of this chapter; or
(2) Discovers is the subject of a violation of
RSA 125-F:19, and which is not subject to the exclusion, exemption, or
authorization described in paragraph (b)(1) above.
(c) Any person who has a responsibility to report
pursuant to (b) above, shall report as soon as possible, as follows:
(1) To DHHS/RHS by telephoning DHHS/RHS, Monday
through Friday between the hours of 8:00 a.m. and 4:30 p.m., at (603) 271-4588;
(2) To the NH State Police on all state holidays
and at any other time not specified in (c)(1) above, at (603) 271-3636; and
(3) The person shall report a description of the
source of radiation, its location and provide the name and phone number of the
person making the report.
Source. #10805, eff 3-28-15
PART He-P 4002 –
RESERVED
PART He-P
4003 DEFINITIONS
He-P 4003.01 Definitions.
(a) “A1” means the maximum activity of
special form radioactive material permitted in a Type A package, as defined in
He-P 4037.
(b) “A2” means the maximum activity of
radioactive material, other than special form radioactive material, permitted
in a Type A package, as defined in He-P 4037.
(c) “Absorbed dose” means the energy imparted by
ionizing radiation per unit mass of irradiated material, expressed in units of
the gray (Gy) or the rad.
(d) “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 at energies usually in excess of one million
electron volts (1MeV). This term
includes “particle accelerator.”
(e) “Accelerator-produced radioactive material”
means any material made radioactive by a particle accelerator.
(f) “Act” means State of New Hampshire Revised
Statutes Annotated (RSA), Chapter 125-F, Sections 1‑25, Radiological
Health Program.
(g) “Activity” means the rate of disintegration
or transformation or decay of radioactive material in units of the Becquerel (Bq) or the curie (Ci).
(h) “Adult” means an individual 18 or more years
of age.
(i) “Agreement State”
means any state with which the U.S. Nuclear Regulatory Commission or the U.S.
Atomic Energy Commission has entered into an effective agreement under
subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).
(j) “Airborne radioactive material” means any
radioactive material dispersed in the air in the form of dusts, fumes,
particulates, mists, vapors, or gases.
(k) “Airborne radioactivity area” means a room,
enclosure, or area in which airborne radioactive materials, composed wholly or
partly of licensed material, exist in concentrations:
(1) That are in excess of
the derived air concentrations (DACs) specified in He-P 4090; or
(2) 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.
(l) “Air-purifying respirator” means a respirator
with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through
the air-purifying element.
(m)
“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 and 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.
(n) “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 economics of improvements in relation to benefits
to the public health and safety, and other societal and socio-economical considerations, and in relation to utilization
of nuclear energy and licensed or registered sources of radiation in the public
interest.
(o) “Assigned protection factor (APF)” means the
expected workplace level of respiratory protection that would be provided by a
properly functioning respirator or a class of respirators to properly trained
and fitted users.
(p) “Atmosphere-supplying respirator” means a
respirator that supplies the respirator user with breathing air from a source
independent of the ambient atmosphere, and includes supplied-air respirators
(SARs) and self-contained breathing apparatus (SCBA) units.
(q) “Background radiation” means:
(1) Radiation from cosmic sources;
(2) Naturally occurring radioactive materials,
which have not been technologically enhanced, including radon, except as a
decay product of source or special nuclear material;
(3) Global fallout as it exists in the
environment from the testing of nuclear explosive devices or from past nuclear
accidents that contribute to background radiation and are not under the control
of the licensee or registrant; and
(4) Not radiation from sources or byproduct
materials regulated by the DHHS/RHS.
(r) “Becquerel (Bq)”
means a unit of activity where one becquerel is equal to one disintegration per
second (dps) or transformation per second (tps).
(s) “Bioassay” means the determination of kinds,
quantities or concentrations, and 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. This term
includes “radiobioassay.”
(t) “Brachytherapy” means a method of radiation
therapy in which sealed sources are utilized to deliver a radiation dose at a
distance of up to a few centimeters, by surface, intracavitary, or interstitial
application.
(u) “Bureau of radiological health (BRH)” means
the former name of the radiological health program of the department of health
and human services.
(v) “Byproduct material” means:
(1) “Byproduct material” as defined in RSA
125-F:3,II, namely “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”;
(2) 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 except underground ore
bodies depleted by these solution extraction operations;
(3) Any discrete source of radium-226 that is
produced, extracted, or converted after extraction for use for a commercial,
medical, or research activity;
(4) Any material that has been made radioactive
by use of a particle accelerator and that is produced, extracted, or converted
after extraction for use for a commercial, medical, or research activity; and
(5) Any discrete source of naturally occurring
radioactive material, other than source material, that:
a. The Governor declares by order to be
byproduct material after the United States 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; and
b. Is extracted or converted after extraction
for use in a commercial, medical, or research activity.
(w) “Calibration” means the determination of:
(1)
The response or reading of an instrument relative to a series of known
radiation values over the range of the instrument, or
(2) The strength of a source of radiation
relative to a standard.
(x) “Chelating agent” means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic
acid, and polycarboxylic acids.
(y) “Class” means a classification scheme for
inhaled material according to its rate of clearance from the pulmonary region
of the lung. This term includes
“inhalation class” or “lung class.”
(z) “Class D” means a class having a range of
clearance half-times of less than 10 days.
(aa) “Class W” means a class having a range of
clearance half-times of 10 to 100 days.
(ab) “Class Y” means a class having a range of
clearance half-times of greater than 100 days.
(ac) “Clearance half time” means the time required
for activity in the pulmonary region of the lung to be reduced by radioactive
decay and biological processes to one half its value.
(ad) “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.
(ae) “Commencement of construction” means taking
any action defined as “construction” or any other activity at the site of a
facility subject to the rules in this part that has a reasonable nexus to
radiological health and safety.
(af) “Commissioner”
means the commissioner of the New Hampshire department of health and human
services, or his or her designee.
(ag) “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.
(ah) “Committed effective dose equivalent (HE,50)”
is the sum of the products of the weighting factors (wT)
applicable to each of the body organs or tissues that are irradiated and the
committed dose equivalent (HT,50) to each of these organs
or tissues (HE,50 = ΣWT HT,50).
(ai) “Condition of light work” means an inhalation
rate of 1.2 cubic meters of air per hour for 2,000 hours in a year.
(aj) “Consortium” means an association of medical use
licensees and a Positron Emission Tomography (PET) radionuclide production
facility in the same geographical area that jointly own or share in the
operation and maintenance cost of the PET radionuclide production facility that
produces PET radionuclides for use in producing radioactive drugs within the
consortium for noncommercial distributions among its associated members for
medical use. The PET radionuclide production
facility within the consortium must be located at an educational institution or
a Federal facility or a medical facility.
(ak)
“Constraint” means a value above which specified license actions are
required. This term includes “dose
constraint.”
(al) “Controlled area” means an area, outside of a
restricted area but inside the site boundary, access to which can be limited by
the licensee or registrant for any reason.
(am) “Critical
group” means the group of individuals reasonably expected to receive the
greatest exposure to residual radioactivity for any applicable set of
circumstances.
(an) “Curie” means a unit of quantity of radioactivity in which
one curie (Ci) is that quantity of radioactive material which decays at the
rate of 3.7E+10 transformations per second (tps).
(ao) “Cyclotron” means a particle accelerator in
which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at
energies usually in excess of 10 megaelectron volts
and is commonly used for production of short half-life radionuclides for
medical use.
(ap) “Declared pregnant woman” means a woman who
has voluntarily informed her employer, in writing, of her pregnancy and the
estimated date of conception. The
declaration remains in effect until the declared pregnant woman withdraws the
declaration in writing or is no longer pregnant.
(aq) “Decommission”
means to remove a facility or site safely from service and reduce residual
radioactivity to a level that permits:
(1) Release of the property for unrestricted use
and termination of the license; or
(2) Release of the property under restricted
conditions and termination of the license.
(ar) “Decommissioning plan” means a written document that
includes the licensee’s planned procedures and activities for decommissioning
of the facility or site.
(as) “Deep dose equivalent (Hd),”
applicable to external whole-body exposure, means the dose equivalent at a
tissue depth of one centimeter (1000 mg/cm2).
(at) “Demand respirator” means an
atmosphere-supplying respirator that admits breathing air to the facepiece only
when a negative pressure is created inside the facepiece by inhalation.
(au) “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 exclusive of special nuclear material.
(av) “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.
(aw) “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.
(ax) “Discrete source” means a radionuclide that
has been processed so that its concentration within a material has been
purposely increased for use for commercial, medical, or research activities.
(ay) “Disposable respirator” means a respirator
for which maintenance is not intended and that is designed to be discarded
after excessive breathing resistance, sorbent exhaustion, physical damage, or
end-of-service-life renders it unsuitable for use. Examples of this type of
respirator are a disposable half-mask respirator or a disposable escape-only
self-contained breathing apparatus (SCBA).
(az) “Distinguishable from background” means that
the detectable concentration of a radionuclide is statistically different
from the background concentration of that radionuclide in the vicinity of the
site or, in the case of structures, in similar materials using adequate
measurement technology, survey, and statistical techniques.
(ba) “Dose” means a generic term that includes
absorbed dose, dose equivalent, effective dose equivalent, committed dose
equivalent, committed effective dose equivalent, or total effective dose
equivalent. This term includes
“radiation dose.”
(bb) “Dose equivalent (HT)” means the
product of the absorbed dose in tissue, quality factor, and all other necessary
modifying factors at the body location of interest in units of the sievert (Sv) or rem.
(bc) “Dose limits” means the permissible upper
bounds of radiation doses established in accordance with these rules.
(bd) “Dosimetry processor” means an individual or
an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the
monitoring devices.
(be) “Effective dose equivalent (HE)”
means the sum of the products of the dose equivalent to each organ or tissue (HT)
and the weighting factor (wT) applicable
to each of the body organs or tissues that are irradiated.
(bf) “Embryo/fetus” means the developing human
organism from conception until the time of birth.
(bg) “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 radioactive
materials which include entry or exit portals of sufficient size to permit
human entry.
(bh) “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.
(bi) “Exposure” means being exposed to ionizing radiation
or to radioactive material.
(bj) “Exposure rate” means the exposure per unit
of time.
(bk) “External dose” means that portion of the
dose equivalent received from any source of radiation outside the body.
(bl) “Extremity” means hand, elbow, arm below the
elbow, foot, knee, and leg below the knee.
(bm) “Facility” means the location within one
building, vehicle, or under one roof and under the same administrative control at
which:
(1)
The possession, use, processing or storage of
radioactive material is or was authorized; or
(2)
One or more radiation-producing machines or radioactivity-inducing
machines are installed or located.
(bn) “Filtering facepiece” means a
negative pressure particulate respirator with a filter as an integral part of
the facepiece or with the entire facepiece composed of the filtering medium,
not equipped with elastomeric sealing surfaces and adjustable straps. This term includes “dust mask.”
(bo) “Fit factor” means a quantitative estimate of
the fit of a particular respirator to a specific individual, and typically
estimates the ratio of the concentration of a substance in ambient air to its
concentration inside the respirator when worn.
(bp) “Fit test” means the use of a protocol to qualitatively or quantitatively evaluate the fit of a
respirator on an individual.
(bq) “Final radiation
survey” means the survey of the facility or site after decommissioning
activities have been completed during which the determination is made by the
licensee that the facility or site meets the DHHS/RHS’s release criteria.
(br) “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.
(bs) “Generally applicable environmental radiation
standards” means standards issued by the U.S. Environmental Protection Agency
(EPA) under the authority of the Atomic Energy Act of 1954, as amended, that
impose limits on radiation exposures or levels, or concentrations or quantities
of radioactive material, in the general environment outside the boundaries of
locations under the control of persons possessing or using radioactive
material.
(bt) “Gray (Gy)” means
the SI unit of absorbed dose where one gray is equal to an absorbed dose of one
joule per kilogram which is equal to 100 rad.
(bu) “Hazardous waste” means those wastes designated
as hazardous by U.S. Environmental Protection Agency regulations in 40 CFR 261.
(bv) “Healing arts” means the diagnosis and
treatment of ailments for humans.
(bw) “Helmet” means a rigid respiratory inlet
covering that also provides head protection against
impact and penetration.
(bx) “High radiation area” means an area,
accessible to individuals, in which radiation levels could result in an
individual receiving a dose equivalent in excess of
one millisievert (mSv) or “0.1 rem” in one hour at 30 centimeters from any
source of radiation or from any surface that the radiation penetrates.
(by) “Hood” means a respiratory inlet covering
that completely covers the head and neck and may also cover portions of the
shoulders and torso.
(bz) “Human use” means the internal or external
administration of radiation or radioactive material to human beings.
(ca) “Individual” means any human being.
(cb) “Individual monitoring” means the assessment
of:
(1)
Dose equivalent by the use of individual
monitoring devices or by the use of survey data; or
(2)
Committed effective dose equivalent by bioassay or by determination of
the time-weighted air concentrations to which an individual has been exposed,
that is, DAC-hours.
(cc) “Individual monitoring devices” means devices
designed to be worn by a single individual for the assessment of dose
equivalent, and includes film badges, thermoluminescent
dosimeters (TLDs), pocket ionization chambers, optically stimulated
luminescence (OSL) dosimeters, and personal air sampling equipment. This term includes “personnel monitoring
equipment.”
(cd) “Inspection” means an official examination or
observation to determine compliance with rules and orders of the DHHS/RHS.
(ce) “Instrument traceability” means the ability
to show for ionizing radiation measurements that an instrument has been
calibrated at specified time intervals using a national standard or a transfer
standard which was calibrated at a laboratory accredited by a program which
requires continuing participation in measurement quality assurance with the
National Institute of Standards and Technology, or other equivalent national or
international program.
(cf) “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.
(cg) “Internal dose” means that portion of the
dose equivalent received from radioactive material taken into the body.
(ch) “International System of Units (SI)” means
the modern form of the metric system. As used in this
rule, “SI” means that the measurement is in the International System of Units.
(ci) “Lens dose equivalent (LDE)” means the
external exposure to the lens of the eye as the dose equivalent at a tissue
depth of 0.3 centimeter (300 mg/cm2).
(cj) “License” means
a “license” as defined in RSA 125-F:3 IX, namely, “general or specific: (a)
“General license” means a license pursuant to rules adopted by the program
without the filing of an application with the program, or the issuance of
licensing documents to particular persons to transfer,
acquire, own, possess or use quantities of, or devices or equipment utilizing,
radioactive material. (b) “Specific license” means a license issued to a name
person upon application filed pursuant to the rules adopted under this chapter,
to use, manufacture, produce, transfer, receive, acquire, own
or possess quantities of, or devices or equipment utilizing, radioactive
material.”
(ck) “Licensed material”
means source material, special nuclear material, or byproduct material
received, possessed, used, transferred, or disposed of under a license issued
by the DHHS/RHS.
(cl) “Licensee” means:
(1) Any person who is licensed by
the DHHS/RHS in accordance with the Act and He-P 4000; or
(2) Any person who is responsible for decommissioning by being registered
with the DHHS/RHS, being subject to a record of possession of a radiation
source or device under general license, or being otherwise legally obligated to
conduct decommissioning activities in accordance with these regulations and the
Act.
(cm) “Licensing State” means any state with
regulations or rules equivalent to the Suggested State Rules for Control of
Radiation relating to, and having an effective program for, the regulatory
control of NARM and which has been granted “final designation” by the
Conference of Radiation Control Program Directors, Inc.
(cn) “Limits” means
the permissible upper bounds of radiation doses.
(co) “Loose-fitting facepiece” means a respiratory
inlet covering that is designed to form a partial seal with the face.
(cp) “Lost or missing licensed material or sources
of radiation” means licensed or registered sources of radiation whose location
is unknown or that has been shipped but has not reached its planned destination
and whose location cannot be readily traced in the transportation system.
(cq) “Lost or missing sources of radiation” means
licensed or registered sources of radiation whose location is unknown or that
have been shipped but has not reached its planned destination and whose
location cannot be readily traced.
(cr) “Major processor” means a user processing,
handling, or manufacturing radioactive material exceeding Type A quantities as
defined in 10 CFR 71.4 as unsealed sources or material, or exceeding 4 times
Type B quantities as defined in 10 CFR Part 71.4 as sealed sources, exclusive
of nuclear medicine programs, universities, or industrial radiography.
(cs) “Member of the public” means any individual,
except an individual who is performing assigned duties for a licensee or
registrant involving exposure to sources of radiation.
(ct) “Minor” means an
individual less than 18 years of age.
(cu) “Monitoring” means the measurement of
radiation levels, radioactive material concentrations, surface area activity or
quantities of radioactive material and the use of the results of these
measurements to evaluate potential exposures and doses.
(cv) “NARM” means any naturally occurring or
accelerator-produced radioactive material other than byproduct, source, or
special nuclear material.
(cw) “Nationally tracked source” means a sealed
source containing a quantity equal to or greater than Category 1 or Category 2
levels of any radioactive material listed in He-P 4097. In this context a sealed source is defined as
radioactive material that is sealed in a capsule or closely bonded, in a solid
form and which is not exempt from regulatory control. It does not mean material
encapsulated solely for disposal, or nuclear material contained in any fuel
assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are
those containing radioactive material at a quantity equal to or greater than
the category 1 threshold. Category 2
nationally tracked sources are those containing radioactive material at a
quantity equal to or greater than the Category 2 threshold but less than the
Category 1 threshold.
(cx) “Natural radioactivity” means radioactivity
of naturally occurring nuclides.
(cy) “Negative pressure respirator (tight
fitting)” means a respirator in which the air pressure inside the facepiece is
negative during inhalation with respect to the ambient air pressure outside the
respirator. This term includes “tight
fitting negative pressure respirator.”
(cz) “Nonstochastic
effect” means a health effect, the severity of which varies with the dose and
for which a threshold is believed to exist.
(da) “NORM” means any naturally occurring
radioactive material, and excludes byproduct, source, or special nuclear
material.
(db) “Nuclear
facility” means any facility that uses radioactive material.
(dc) “Nuclear Regulatory Commission (NRC)” means
the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
(dd) “Occupational dose” means the dose received
by an individual in the course of employment in which the individual's assigned
duties for the licensee or registrant involve exposure to sources of radiation,
or to radioactive material from licensed and unlicensed sources of radiation, whether or not the sources of radiation are in the
possession of the licensee, registrant or other person, exclusive of dose
received:
(1) From background radiation;
(2) As a patient from medical practices;
(3) From exposure to individuals administered
radioactive material and released under He-P 4035.25;
(4) From voluntary participation in medical
research programs; or
(5) As a member of the public.
(de) “Package” means packaging plus its
radioactive contents as presented for transport.
(df) “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 at energies usually in excess of
one megaelectron volt. For purposes of
this definition, “accelerator” is an equivalent term.
(dg) “Person” means “person” as defined in RSA
125-F:3, XII, namely “any individual, corporation, partnership, firm,
association, trust, estate, public or private institution, group, agency of
this state other than the program, political subdivision of this state, any
other state or political subdivision or agency, and any legal successor,
representative, or agent of the foregoing, other than federal government
agencies”.
(dh) “Pharmacist” means “licensed pharmacist or
pharmacist” as defined in RSA 318:1, VII, namely, “when not otherwise limited,
means a person holding a license under RSA 318:18 and who is, therefore,
legally authorized to practice the profession of pharmacy in this state.”
(di) “Physician” means an individual licensed in
this state to practice medicine.
(dj) “Planned special exposure” means an
infrequent exposure to radiation, separate from and in addition to the annual
occupational dose limits.
(dk) “Positive pressure respirator” means a
respirator in which the pressure inside the respiratory inlet covering exceeds
the ambient air pressure outside the respirator.
(dl) “Powered air-purifying respirator (PAPR)”
means an air-purifying respirator that uses a blower to force the ambient air
through air-purifying elements to the inlet covering.
(dm) “Pressure demand respirator” means a positive
pressure atmosphere-supplying respirator that admits breathing air to the
facepiece when the positive pressure is reduced inside the facepiece by
inhalation.
(dn) “Principal activity” means an activity
authorized by the license which is essential to achieving the purpose(s) for
which the license was issued or amended, and excludes storage during which no
licensed material is accessed for use or disposal and activity incidental to
decontamination or decommissioning.
(do) “Protective apron” means an apron made of
radiation‑attenuating materials used to reduce exposure to radiation.
(dp) “Public dose” means the dose received by a
member of the public from exposure to radiation or to radioactive material
released by licensed or registered operators or to any other source of
radiation under the control of a licensee or registrant. Public dose does not include occupational
dose, dose received from background radiation, dose received as a patient from
medical administration, dose from exposure to individuals administered
radioactive material and released under He-P 4035.25, or dose from voluntary
participation in medical research programs.
(dq) “Pyrophoric liquid” means any liquid that
ignites spontaneously in dry or moist air at or below 130° F (54.4° C).
(dr) “Pyrophoric solid” means any solid material,
or spontaneously combustible and water-reactive other than one classed as an
explosive, which under normal conditions is liable to cause fires through
friction, retained heat from manufacturing or processing, or which can be
ignited readily and, when ignited, burns so vigorously and persistently as to
create a serious transportation, handling, or disposal hazard.
(ds) “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 the American Board of
Medical Physics, or those having equivalent qualifications. With reference to
the calibration of radiation therapy equipment, this term includes 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 radiation oncology by the American Board of Radiology,
or those having equivalent qualifications.
(dt) “Qualitative fit test (QLFT)” means a
pass/fail fit test to assess the adequacy of respirator fit that relies on the
individual’s response to the test agent.
(du) “Quality factor (Q)” means the modifying
factor, listed in Tables 4001.1 and 4001.2 of He-P 4001.09, that is used to
derive dose equivalent from absorbed dose.
(dv) “Quantitative fit test (QNFT)” means an
assessment of the adequacy of respirator fit by numerically measuring the
amount of leakage into the respirator.
(dw) “Quarter” means not less than 12 consecutive
weeks nor more than 14 consecutive weeks arranged so that the first calendar
quarter begins in January and that in subsequent calendar quarters 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. This term includes “calendar quarter.”
(dx) “Rad” means the special unit of absorbed dose
where one rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule
per kilogram.
(dy) “Radiation” means “radiation” as defined in
RSA 125-F:3, XIV, namely, “ionizing radiation and nonionizing radiation: (a)
‘Ionizing radiation’ means gamma rays and x-rays, alpha and beta particles,
high speed electrons, neutrons, protons, and other nuclear particles, but not
sound or radio waves or visible, infrared or ultraviolet light; (b)
‘Nonionizing radiation’ means: (1) Any electromagnetic radiation other than
ionizing radiation which the program determines by rule to present a biological
hazard to the occupational or public health and safety; and (2) Any sonic,
ultrasonic, or infrasonic wave which the program determines by rule to present
a biological hazard to the occupational or public health or safety.”
(dz) “Radiation area” means any area, accessible
to individuals, in which radiation levels could result in an individual
receiving a dose equivalent in excess of 0.05 mSv or
0.005 rem in one hour at 30 centimeters from the source of radiation or from
any surface that the radiation penetrates.
(ea) “Radiation equipment” means “radiation
equipment” as defined in RSA 125-F:3, XV, namely, “any manufactured product or
device, the component part of such product or device, or any machine or system
which during operation is able to generate or emit radiation, except those
which emit radiation only from radioactive material.” The term includes
“radiation machine”.
(eb) “Radiation safety officer” means an
individual who:
(1) Has the knowledge and responsibility to apply
appropriate radiation protection rules and has been assigned such responsibility
by the licensee or registrant;
(2) Meets the requirements in both He-P 4035.08
and He-P 4035.61, or meets the requirements in He-P 4035.62; or
(3) Is identified as a radiation safety officer on
an Agency license, a Nuclear Regulatory Commission license, or Agreement State
license or other equivalent permit or license recognized by the Agency for
similar types and uses of byproduct material.
(ec) “Radioactive material” means “radioactive
material” as defined in RSA 125-F:3, XVI, namely, “any material, whether solid,
liquid, or gas, which emits radiation spontaneously. It includes artificially
produced, byproduct, naturally occurring, source, and special nuclear
materials.” The term includes byproduct material.
(ed) “Radioactivity” means the transformation of
unstable atomic nuclei by the emission of radiation.
(ee) “Radiological
health section (RHS)” means the radiological health section of the division of
public health services in the NH department of health and human services.
(ef)
“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.
(eg) “Registrant” means any person who is
registered with the DHHS/RHS and is legally obligated to register with the
DHHS/RHS pursuant to these rules and the Act.
(eh) “Registration” means “registration” as
defined in RSA 125-F:3, XVIII, namely, “registration in accordance with rules
adopted pursuant to this chapter.”
(ei) “Regulations of the U.S. Department of
Transportation” means the regulations in 49 CFR 100-189.
(ej) “Rem” means the special unit of any of the
quantities expressed as dose equivalent equal to the absorbed dose in rad
multiplied by the quality factor.
(ek) “Research and development” means:
(1) Theoretical analysis, exploration, or
experimentation; or
(2) 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 but does
not include the internal or external administration of radiation or radioactive
material to human beings.
(el) “Residual radioactivity” means radioactivity
in structures, materials, soils, groundwater, and other media at a site
resulting from activities under the licensee’s control, but not background
radiation, and includes:
(1) Radioactivity from all licensed and
unlicensed sources used by the licensee; and
(2) Radioactive materials remaining at the site as a result of routine or accidental releases of radioactive
materials at the site and previous burials at the site, even if those burials
were made in accordance with the provisions of these regulations.
(em) “Respiratory protective device” means an
apparatus, such as a respirator, used to reduce an individual's intake of
airborne radioactive materials.
(en) “Restricted area” means an 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 and
radioactive materials exclusive of areas used as residential quarters, other
than separate rooms in a residential building which may be set apart as a
restricted area.
(eo) “Restricted use” means that a limit or
control has been placed on future use of the facility and the facility is no
longer under the control of the licensee, registrant, of holder of the record
of possession.
(ep) “Roentgen” means the special unit of exposure
where one roentgen (R) equals 2.58E-4 coulombs per kilogram of air.
(eq) “Sanitary sewerage” means a system of public
sewers for carrying off waste water and refuse, but
excluding sewage treatment facilities, septic tanks, and leach fields owned or
operated by the licensee or registrant.
(er) “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.
(es) “Sealed source and device registry (SSD)”
means the national registry that contains the registration certificates,
maintained by the Nuclear Regulatory Commission (NRC), that summarize the
radiation safety information for sealed sources and devices, and describe the
licensing and use conditions approved for the product.
(et) “Self-contained breathing apparatus (SCBA)”
means an atmosphere-supplying respirator for which the breathing air source is
designed to be carried by the user.
(eu) “Shallow dose equivalent (Hs)” means the dose
equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2)
applicable to the external exposure of the skin of the whole body or the skin
of an extremity.
(ev) “Short-lived radon daughters for radon-222”
means polonium-218, lead-214, bismuth-214, and polonium-214.
(ew) “Short-lived radon daughters for radon-220”
means polonium-216, lead-212, bismuth-212, and polonium-212.
(ex) “Sievert” means the SI unit of any of the
quantities expressed as dose equivalent which in sieverts is equal to the
absorbed dose in grays multiplied by the quality factor.
(ey) “Site” means the area contained within the
boundary of a location under the control of persons generating or storing
radioactive materials.
(ez) “Site boundary” means that line beyond which
the land or property is not owned, leased, or otherwise controlled by the
licensee or registrant.
(fa) “Source material” means “source material” as
defined in RSA 125-F:3, XIX, namely, “(a) uranium, thorium, or any other
material which the governor declares by order to be source material after the
United States Nuclear Regulatory Commission or its successor has determined the
material to be source material; or (b) ores containing one or more of the
foregoing materials in such concentration as the governor declares by order to
be source material after the United States Nuclear Regulatory Commission or its
successor has determined the material in such concentration to be source
material.”
(fb) “Source material milling” means any activity
that results in the production of radioactive material as defined in He-P
4003.01(ea).
(fc) “Source of radiation” means “source of
radiation” as defined in RSA 125-F:3, XX, namely, “collectively, radioactive
material and radiation equipment.”
(fd) “Source traceability” means the ability to
show that a radioactive source has been calibrated either by the national
standards laboratory of the National Institute of Standards and Technology, or
by a laboratory which participates in a continuing measurement quality
assurance program with the National Institute of Standards and Technology or an
equivalent national or international program.
(fe) “Special form radioactive material” means
radioactive material that satisfies the following conditions:
(1) It
is either a single solid piece or is contained in a sealed capsule that can be
opened only by destroying the capsule;
(2)
The piece or capsule has at least one dimension not less than 5
millimeters or “0.2 inch”; and
(3) It
satisfies the test requirements specified by the U.S. Nuclear Regulatory
Commission.
(ff) “Special nuclear material” means “special
nuclear material” as defined in RSA 125-F:3, XXI, namely, “(a) plutonium,
uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any
other material which the governor declares by order to be special nuclear
material after the United States Nuclear Regulatory Commission or its successor
has determined the material to be special nuclear material, but does not
include source material; or (b) any material artificially enriched by any of
the foregoing, but does not include source material.”
(fg) “Special nuclear material in quantities not
sufficient to form a critical mass” means:
(1)
Uranium enriched in the isotope U-235 in quantities not exceeding 350
grams of contained U-235;
(2)
Uranium-233 in quantities not exceeding 200 grams;
(3)
Plutonium in quantities not exceeding 200 grams; or
(4) Any
combination of them so that the ratio between the quantity of the special
nuclear material on hand and the quantity specified above for the same kind of
special nuclear material, summed for all of the kinds
of special nuclear material in combination does not exceed one.
(fh) “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 linear function of dose without
threshold, such as hereditary effects and cancer incidence.
(fi) “Storage” means a condition in which a device
or source is not being used for an extended period of time,
and has been made inoperable.
(fj) “Supplied-air respirator (SAR)” means an
atmosphere-supplying respirator for which the source
of breathing air is not designed to be carried by the user. This term includes “airline respirator.”
(fk) “Survey” means an evaluation of the
radiological conditions and potential hazards incident to the production, use,
transfer, release, disposal, or presence of radioactive material or other
sources of radiation. When appropriate,
such an evaluation includes a physical survey of the location of radioactive
material and measurements or calculations of levels of radiation, or
concentrations or quantities of radioactive material present.
(fl) “Test” means the process of verifying
compliance with an applicable rule.
(fm) “Tight-fitting
facepiece” means a respiratory inlet covering that forms a complete seal with
the face.
(fn) “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.
(fo) “Total organ dose equivalent (TODE)” means
the sum of the deep dose equivalent, as defined in
He-P 4003.01(ar), and the committed dose
equivalent, as defined in He-P 4003.01(af), and recorded for the maximally exposed organ.
(fp) “Traceable to a
national standard” means:
(1) The ability to show for ionizing radiation
measurements that an instrument has been calibrated at specified time intervals
using a national standard or a transfer standard which was calibrated at a
laboratory accredited by a program which requires continuing participation in
measurement quality assurance with the National Institute of Standards and
Technology (NIST), or other equivalent national or international program; or
(2) The ability to show that a radioactive source
has been calibrated either by the national standards laboratory of the NIST, or
by a laboratory which participates in a continuing measurement quality
assurance program with NIST or an equivalent national or international program.
(fq) “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, 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
established by Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42
U.S.C. 5814, effective January 19, 1975 and retransferred to the Secretary of
Energy pursuant to section 301(a) of the Department of Energy Organization Act
established by Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42
U.S.C. 7151, effective October 1, 1977.
(fr) “Unrefined and unprocessed ore” means ore in
its natural form prior to any processing.
(fs) “Unrestricted area” means an area access to
which is neither limited nor controlled by the licensee or registrant.
(ft) “Unrestricted use” means that the facility or
area may be used by individuals for any purpose without limits or controls, and
is no longer under the control of the licensee, registrant, or holder of the
record of possession.
(fu) “User seal check (fit check)” means an action
conducted by the respirator user to determine if the respirator is properly
seated to the face. Examples include
negative pressure check, positive pressure check, irritant smoke check, or
isoamyl acetate check.
(fv) “Very high radiation area” means an area,
accessible to individuals, in which radiation levels from radiation sources
external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in one
hour at one meter from a source of radiation or one meter from any surface that the
radiation penetrates.
(fw)
“Waste” means “low-level radioactive waste” as defined in RSA 125-F:3, X,
namely, “radioactive waste not classified as high-level radioactive waste,
transuranic waste, spent nuclear fuel, or byproduct material as defined in
paragraph II.” This term includes radioactive waste not classified as byproduct
material as defined in (v) above and includes radioactive wastes that are
permissible for disposal in a land disposal facility.
(fx) “Waste handling licensees” mean persons
licensed to receive and store radioactive wastes prior to disposal and/or
persons licensed to dispose of radioactive waste.
(fy) “Week” means 7 consecutive days starting on
Sunday.
(fz) “Weighting factor (WT) for an
organ or tissue (T)” means the proportion of the risk of stochastic effects
resulting from irradiation of that organ or tissue to the total risk of
stochastic effects when the whole body is irradiated uniformly.
(ga) “Whole body” means external exposure of head,
trunk including male gonads, arms above the elbow, or legs above the knee.
(gb) “Worker” means an individual engaged in
activities under a license or registration issued by the DHHS/RHS and
controlled by a licensee or registrant, but does not include the licensee or
registrant.
(gc) “Working level (WL)” means any combination of
short-lived radon daughters in one liter of air that will result in the
ultimate emission of 1.3E+5 MeV of potential alpha particle energy.
(gd) “Working level month (WLM)” means an exposure
to one working level for 170 hours and calculated as 2,000 working hours per
year divided by 12 months per year and is approximately equal to 170 hours per
month.
(ge)
“Year” means the period of time beginning in
January used to determine compliance with the provisions of these rules.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14; amd by #12100, eff 2-3-17
PARTS He-P 4004 -
4018 – RESERVED
PART He-P
4019 NOTICES, INSTRUCTIONS, AND REPORTS
TO WORKERS; INSPECTIONS
He-P 4019.01 Purpose. He-P 4019
establishes requirements for notices, instructions, and reports by licensees
or registrants to individuals engaged in activities under a license or
registration and options available to such individuals in connection with the
department of health and human services/radiological health section (DHHS/RHS)
inspections of licensees or registrants to ascertain compliance with the
provisions of the Act and rules, orders, and licenses issued thereunder
regarding radiological working conditions.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.02 Scope.
The rules in this part shall apply to all persons who receive, possess,
use, own, or transfer sources of radiation registered with or licensed by
DHHS/RHS.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.03 Posting of Notices to Workers.
(a) Each licensee shall post, at each facility
licensed, current copies of the following documents:
(1) The rules in He-P 4019 through 4023;
(2) The license, license conditions or documents
incorporated into the license by reference and amendments thereto;
(3) The operating procedures applicable to
activities under the license; and
(4) Any notice of violation involving
radiological working conditions, proposed imposition of civil penalty, or order
issued by the commissioner pursuant to the Act, and any response from the
licensee.
(b) Each registrant shall post, at each facility
registered, current copies of the following documents:
(1) The rules in He-P 4019 through 4022;
(2) The certificate of registration;
(3) The operating procedures applicable to
activities under the registration; and
(4) Any notice of violation involving
radiological working conditions, proposed imposition of civil penalty, or order
issued by the commissioner pursuant to the Act, and any response from the
registrant.
(c) If posting of a document specified in He-P 4019.03(a) or (b) is not practicable, the licensee
or registrant shall post a notice which describes the document and states where
it may be examined.
(d) The DHHS/RHS Notice RHS-5, “Notice to
Employees” shall be posted by each licensee or registrant.
(e) DHHS/RHS documents posted pursuant to He-P
4019.03(a)(4) or (b)(4) shall be posted within 2 working days after receipt of
the documents from DHHS/RHS.
(f) The licensee’s or registrant’s response
pursuant to He-P 4019.03(a)(4) or (b)(4), if any, shall be posted within 2
working days after dispatch from the licensee or registrant and shall remain
posted for a minimum of 5 working days or until action correcting the violation
has been completed, whichever is later.
(g) Documents, notices, or forms posted pursuant
to He-P 4019.03 shall:
(1) Appear in a sufficient number of places to
permit individuals engaged in work under the license or registration to observe
them on the way to or from any particular work
location to which the document applies;
(2) Be conspicuous; and
(3) Be replaced if defaced or altered.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.04 Instructions to Workers.
(a) All individuals who in the course of
employment are likely to receive in a year an occupational dose in excess of 1 millisievert (100 mrem) shall:
(1) Be kept informed of the storage, transfer, or
use of sources of radiation in the licensee’s or registrant’s workplace;
(2) Be instructed in:
a. The health protection problems associated
with exposure to radiation or radioactive material to the individual and
potential offspring;
b. Precautions or procedures to minimize
exposure; and
c. The purposes and functions of protective
devices employed;
(3) Be instructed in, and be required to observe,
to the extent within the worker’s control, the applicable provisions of these
rules and licenses for the protection of personnel from exposures to radiation
or radioactive material;
(4) Be instructed of their responsibility to
report promptly to the licensee or registrant any condition which may
constitute, lead to, or cause a violation of the Act, these rules, and license
conditions or unnecessary exposure to radiation or radioactive material;
(5) Be instructed in the appropriate response to
warnings made in the event of any unusual occurrence or malfunction that may
involve exposure to radiation or radioactive material; and
(6) Be advised as to the radiation exposure
reports which workers shall be furnished pursuant to
He-P 4019.05.
(b) The licensee shall consider assigned
activities during normal and abnormal situations involving exposure to
radiation or radioactive material which can reasonably be expected to occur
during the life of the licensed facility in determining those individuals
subject to the requirements of He-P 4019.04(a).
(c) The extent of these instructions shall be
commensurate with potential radiological health protection problems present in
the workplace.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.05 Notifications and Reports to Individuals.
(a) Radiation exposure data for an individual and
the results of any measurements, analyses, and calculations of radioactive
material deposited or retained in the body of an individual shall be reported
to the individual as specified in He-P 4019.05(b)-(k).
(b) The information reported shall include data
and results obtained pursuant to these rules, orders, or license conditions, as
shown in records maintained by the licensee or registrant pursuant to He-P 4021.07.
(c) Each notification and report shall:
(1) Be in writing;
(2) Include appropriate identifying data such as:
a. The name of the licensee or registrant;
b. The name of the individual; and
c. The individual’s identification number;
(3) Include the individual’s exposure
information; and
(4) Contain the following statement:
“This report is
furnished to you under the provisions of He-P 4019. You should preserve this report for further
reference.”
(d) Each licensee or registrant shall make dose
information available to workers as shown in records maintained by the licensee
or registrant under the provisions of He-P
4021.07. Each licensee or registrant
shall furnish to each worker annually a written report of the worker’s dose as
shown in records maintained by the licensee or registrant pursuant to He-P 4022.02 if:
(1) The individual’s occupational dose exceeds 1
mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or
(2) The individual requests his or her annual
dose report.
(e) At the request of a worker formerly engaged
in activities controlled by the licensee or registrant, each licensee or
registrant shall furnish to the worker a report of the worker’s exposure to
radiation and/or to radioactive material:
(1) As shown in records maintained by the
licensee or registrant to He-P 4021.07 for each year
the worker was required to be monitored under the provisions of He-P 4022.02;
and
(2) For each year the worker was required to be
monitored under the requirements in effect prior to January 1, 1994.
(f) Such report, pursuant to He-P 4019.05(e),
shall be furnished within 30 days from the date of the request, or within 30
days after the dose of the individual has been determined by the licensee or
registrant, whichever is later.
(g) The report, pursuant to He-P 4019.05(e),
shall cover the period of time that the worker’s
activities involved exposure to sources of radiation and shall include the
dates and locations of work under the license or registration in which the
worker participated during this period.
(h) When a licensee or registrant is required
pursuant to He-P 4021.13, He-P 4021.14 or He-P 4021.15
to report to DHHS/RHS any exposure of an individual to sources of radiation,
the licensee or the registrant shall also provide the individual a written
report on the exposure data included therein.
(i) Reports, pursuant
to He-P 4019.05(h), shall be transmitted to the individual at a time not later
than the transmittal to DHHS/RHS.
(j) Each licensee or registrant shall, at the
request of a worker who is terminating employment and whose work involved
exposure to radiation or radioactive material during the current year, provide
at termination to each such worker, or to the worker’s designee, a written
report regarding the radiation dose received by that worker from operations of
the licensee or registrant during the current year or fraction thereof.
(k) If the most recent individual monitoring
results are not available pursuant to He-P 4019.05(j),
a written estimate of the dose shall be provided together with a clear
indication that this is an estimate.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.06 Presence
of Representatives of Licensees or Registrants and Workers During Inspections.
(a) Each licensee or registrant shall allow
DHHS/RHS at any reasonable time to inspect:
(1) Materials;
(2) Machines;
(3) Activities;
(4) Facilities;
(5) Premises; and
(6) Records created and maintained pursuant to
these rules.
(b) During an inspection, DHHS/RHS inspectors may
consult privately with workers, either on their own volition or at the request
of any of the workers, as specified in He-P 4019.07.
(c) The licensee or registrant may accompany
DHHS/RHS inspectors during an inspection at times other than the private
consultation with workers.
(d) If, at the time of inspection, an individual
has been authorized by the workers to represent them during DHHS/RHS
inspections, the licensee or registrant shall notify the inspectors of such
authorization and shall give the workers’ representative an opportunity to
accompany the inspectors during the inspection of physical working conditions.
(e) Each worker’s representative shall be
routinely engaged in work under control of the licensee or registrant and shall
have received instructions as specified in He-P 4019.04.
(f) Different representatives of licensees or
registrants and workers may accompany the inspectors during different phases of
an inspection if there is no resulting interference with the conduct of the
inspection. However, only one workers’
representative at a time may accompany the inspectors.
(g) With the approval of the licensee or
registrant and the workers’ representative, an individual who is not routinely
engaged in work under control of the licensee or registrant, for example, a
consultant to the licensee or registrant or to the workers’ representative,
shall be afforded the opportunity to accompany DHHS/RHS inspectors during the
inspection of physical working conditions.
(h) Notwithstanding the other provisions of He-P
4019.06, DHHS/RHS inspectors shall refuse to permit accompaniment by any
individual who deliberately interferes with a fair and orderly inspection.
(i) With regard to
areas containing information classified by an agency of the U.S. Government in
the interest of national security, an individual who accompanies an inspector
may have access to such information only if authorized by the licensee to do
so.
(j) With regard to any area containing
proprietary information, the workers’ representative for that area shall be an
individual previously authorized by the licensee or registrant to enter that
area.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.07 Consultation with Workers During
Inspections.
(a) DHHS/RHS inspectors may consult privately
with workers or former workers, either on their own volition or at the request
of any of the workers or former workers, concerning matters of occupational
radiation protection and other matters related to applicable provisions of
these rules and licenses for the conduct of an effective and thorough
inspection.
(b) During the course of an inspection, any
worker or former worker may bring privately to the attention of the inspectors,
either orally or in writing, any past or present condition which the worker or
former worker has reason to believe may have contributed to or caused any
violation of the Act, these rules, or license condition, or any unnecessary
exposure of an individual to sources of radiation under the licensee's or
registrant’s control.
(c) Any such notice in writing shall comply with
the requirements of He-P 4019.08(a).
(d) The provisions of He-P 4019.07(b) and (c)
shall not be interpreted as authorization to disregard instructions pursuant to
He-P 4019.04.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.08 Requests by Workers for Inspections.
(a) Any worker or representative of workers
believing that a violation of the Act, these rules, or license conditions
exists or has occurred in work under a license or registration with regard to radiological working conditions in which the
worker is engaged may request an inspection by giving notice of the alleged
violation to DHHS/RHS.
(b) Any such notice shall:
(1) Be in writing;
(2) Set forth the specific grounds for the
notice; and
(3) Be signed by the worker or representative of
the workers.
(c) A copy of the notice shall be provided to the
licensee or registrant by DHHS/RHS no later than at the time of inspection
except that, upon the request of the worker giving such notice, such worker’s
name and the name of individuals referred to therein shall not appear in such
copy or on any record published, released, or made available by DHHS/RHS,
except for good cause shown.
(d) If the complaint meets the requirements set
forth in He-P 4019.08(a) through (c), and there are
reasonable grounds to believe that the alleged violation exists or has
occurred, an inspection shall be made as soon as practicable to determine if
such alleged violation exists or has occurred.
(e) Inspections pursuant to He-P 4019.08 may not
be limited to matters referred to in the complaint.
(f) No licensee, registrant, contractor, or
subcontractor of a licensee or registrant shall discharge or in any manner
discriminate against any worker because such worker has:
(1) Filed any complaint or instituted or caused
to be instituted any proceeding under these rules;
(2) Testified or is about to testify in any such
proceeding; or
(3) Because of the exercise by such worker on
behalf of himself or others of any option afforded by He-P 4019.
(g) If DHHS/RHS determines that an inspection is
not warranted because the requirements of He-P 4019.08 have not been met, the
complainant shall be notified in writing of such determination and shall be
without prejudice to the filing of a new complaint meeting the requirements of
He-P 4019.08.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4019.09 Inspections not Warranted; Informal Review.
(a) If DHHS/RHS determines, with respect to a
complaint under He-P 4019.08 that an inspection is not warranted because there
are no reasonable grounds to believe that a violation exists or has occurred,
DHHS/RHS shall notify the complainant in writing of such determination.
(b) The complainant may obtain review of such
determination by submitting a written position statement with the commissioner,
department of health and human services.
(c) The commissioner shall provide the licensee
or registrant with a copy of such statement by certified mail, excluding, at
the request of the complainant, the name of the complainant.
(d) The licensee or registrant may submit an
opposing written statement of position with the commissioner.
(e) The commissioner shall provide the
complainant with a copy of such statement by certified mail.
(f) Upon the request of the complainant, the
commissioner shall hold an informal conference in which the complainant and the
licensee or registrant shall orally present their views.
(g) An informal conference may also be held at
the request of the licensee or registrant, but disclosure of the identity of
the complainant shall be made only following receipt of written authorization
from the complainant.
(h) After considering all written and oral views
presented, the commissioner shall affirm, modify, or reverse the determination
of DHHS/RHS and furnish the complainant and the licensee or registrant a
written notification of the decision and the reason
therefore.
(i) If DHHS/RHS
determines, with respect to a complaint under He-P 4019.08, that an inspection
is not warranted because the requirements of He-P 4019.08(a) have not been met,
the complainant shall be notified in writing of such determination.
(j) A determination made pursuant to He-P
4019.09(i) shall be without prejudice to the filing
of a new complaint meeting the requirements of He-P 4019.08(a).
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
PART He-P
4020 STANDARDS FOR PROTECTION AGAINST
RADIATION
Statutory Authority RSA 125-F:5,V
He-P 4020.01 Purpose.
(a) He-P 4020 through He-P 4023 establish
standards for protection against ionizing radiation resulting from activities
conducted pursuant to licenses or registrations issued by the DHHS/RHS.
(b) The requirements of He-P 4020 through He P
4023 are designed to control the receipt, possession, use, transfer, and
disposal of sources of radiation by any licensee or registrant so the total
dose to an individual, including doses resulting from all sources of radiation
other than background radiation, does not exceed the standards for protection
against radiation prescribed in He-P 4020 through He-P 4023. However, nothing in He-P 4020 through He-P
4023 shall be construed as limiting actions that may be necessary to protect
health and safety.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.02 Scope.
Except as specifically provided in other parts of these rules, He-P 4020
through He-P 4023 shall apply to persons licensed or registered by the DHHS/RHS
to receive, possess, use, transfer, or dispose of byproduct or sources of
radiation, including special nuclear material.
The limits in He-P 4020 through He-P 4023 shall not apply to doses due
to background radiation, to exposure of patients to radiation for the purpose
of medical diagnosis or therapy, to exposure from individuals administered
radioactive material and released in accordance with He-P 4035.25, or to
voluntary participation in medical research programs.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.03 Implementation.
(a) Any existing license or certificate of
registration condition that is more restrictive than He-P 4020 through He-P
4023 shall remain in force until there is an amendment or renewal of the license
or registration.
(b) If a license or certificate of registration
condition exempts a licensee or registrant from a provision of
He-P 4020 through He-P 4023 in effect on or before August 6, 1998, it shall
also exempt the licensee or registrant from the corresponding provision of He-P
4020 through He-P 4023.
(c) If a license or certificate of registration
condition cites provisions of He P 4020 through He P
4023 in effect prior to August 6, 1998, which do not correspond to any
provisions of He P 4020 through He-P 4023, the license or registration
condition shall remain in force until there is an amendment or renewal of the
license or registration that modifies or removes this condition.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.04 Radiation Protection Programs.
(a) Each licensee or registrant shall develop,
document, and implement a radiation protection program sufficient to ensure
compliance with the provisions of He-P 4020 through He-P 4023.
(b) The licensee or registrant shall use
procedures and engineering controls based upon sound radiation protection
principles to achieve occupational doses and public doses that are as low as is
reasonably achievable (ALARA).
(c) The licensee or registrant shall, at
intervals not to exceed 12 months, review the radiation protection program
content and implementation.
(d) To implement the ALARA requirements of (b)
above and notwithstanding the requirements in He-P 4020.13, a constraint on air
emissions of radioactive material to the environment, excluding Radon-222 and
its daughters, shall be established by licensees other than those subject to
Title 10, Code of Federal Regulations, Part 50.34a of the United States Nuclear
Regulatory Commission (NRC) regulations, such that the individual member of the
public likely to receive the highest dose will not be expected to receive a
total effective dose equivalent in excess of 0.1 millisievert (10 mrem) per
year from these emissions.
(e) If a licensee subject to the requirement of
(d) above exceeds the dose constraint, the licensee shall report the exceedance
as provided in He-P 4021.14 and promptly take appropriate corrective action to
ensure against recurrence.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.05 Occupational Dose Limits for Adults.
(a) The licensee or registrant shall control the
occupational dose to individual adults, except for planned special exposures
pursuant to He-P 4020.10, to the following dose limits:
(1) An
annual limit, which shall be the more limiting of:
a. The total effective dose equivalent being
equal to 0.05 Sv (5 rem); or
b. The sum of the deep dose equivalent and the
committed dose equivalent to any individual organ or tissue other than the lens
of the eye being equal to 0.5 Sv (50 rem); and
(2)
The annual limits to the lens of the eye, to the skin of the whole body,
and to the skin of the extremities which shall be:
a. A lens dose equivalent of 0.15 Sv (15 rem); and
b. A shallow dose equivalent of 0.5 Sv (50 rem) to the skin of the whole body or to the skin of any extremity.
(b) Doses received in excess of
the annual limits, including doses received during accidents, emergencies, and
planned special exposures, shall be subtracted from the limits for planned
special exposures that the individual may receive during the current year and
during the individual’s lifetime.
(c) When the external exposure is determined by
measurement with an external personal monitoring device, the deep-dose
equivalent shall be used in place of the effective dose equivalent, unless the
effective dose equivalent is determined by a dosimetry method acceptable by
DHHS/RHS.
(d) The assigned deep dose equivalent shall be
for the portion of the body receiving the highest exposure.
(e) The assigned shallow dose equivalent shall be
for the dose averaged over the contiguous 10 square centimeters of skin
receiving the highest exposure.
(f) The deep dose equivalent, the lens dose
equivalent, and the shallow dose equivalent may be assessed from surveys or
other radiation measurements for the purpose of demonstrating compliance with
the occupational dose limits, if the individual monitoring device was not in
the region of highest potential exposure, or the results of individual
monitoring are unavailable.
(g) The effective dose equivalent for external
radiation when a protective apron is worn while working with medical fluoroscopic equipment shall be determined
as follows:
(1)
When one individual monitoring device is used and it is located at the
neck outside the protective apron, the reported deep dose equivalent shall be
the effective dose equivalent for external radiation;
(2)
When only one individual monitoring device is used and it is located at
the neck outside the protective apron, and the reported dose equivalent exceeds
25 percent of the limit specified in He-P 4020.05(a), the reported dose
equivalent value multiplied by 0.3 shall be the effective dose equivalent for
external radiation; or
(3)
When individual monitoring devices are worn, both under the protective
apron at the waist and outside the protective apron at the neck, the effective
dose equivalent for external radiation shall be assigned the value of the sum
of the deep dose equivalent reported for the individual monitoring device
located at the waist under the protective apron multiplied by 1.5 and the deep
dose equivalent reported for the individual monitoring device located at the
neck outside the protective apron multiplied by 0.04.
(h) Derived air concentration (DAC) and annual
limit on intake (ALI) values shall be as stated in He-P 4090 and may be used to
determine the individual’s dose and to demonstrate compliance with the
occupational dose limits.
(i) Notwithstanding
the annual dose limits, the licensee shall limit the soluble uranium intake by
an individual to 10 milligrams in a week in consideration of chemical toxicity.
(j) The licensee or registrant shall reduce the
dose that an individual may be allowed to receive in the current year by the
amount of occupational dose received while employed by any other person during
the current year.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.06 Compliance with
Requirements for Summation of External and Internal Doses.
(a) If the licensee or registrant is required to
monitor pursuant to He-P 4022.02 (a), (b) and (c), the
licensee or registrant shall demonstrate compliance with the dose limits by
summing external and internal doses.
(b) If the licensee or registrant is required to
monitor only pursuant to He-P 4022.02(b) or only
pursuant to He-P 4022.02(c), then summation is not required to demonstrate
compliance with the dose limits.
(c) The licensee or registrant may demonstrate
compliance with the requirements for summation of external and internal doses
pursuant to He-P 4020.06 (f), (g), or (h).
(d) The dose equivalents for the lens of the eye,
the skin, and the extremities shall not be included in the summation, but shall
be subject to separate limits.
(e) For calculating the effective dose
equivalent, the values of WT shall be as per Table 4020.1 below:
Table 4020.1 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 |
Whole Body |
1.00 |
(f) The organ dose weighting factor of 0.30 in
Table 4020.1 shall result from 0.06 for each of 5 “remainder” organs, excluding
the skin and the lens of the eye, that receive the highest doses.
(g) A licensee or registrant may request the use
of weighting factors for external exposure other than that specified in Table
4020.1, for situations when reliable, accurate, and predictable estimates of
the effective dose equivalent are possible, and approved by the DHHS/RHS under
a license issued in accordance with He-P 4030, or a registration issued in
accordance with He-P 4040.
(h) If the only intake of radionuclides is by
inhalation, the total effective dose equivalent limit shall not be exceeded if
the sum of the deep dose equivalent divided by the total effective dose
equivalent limit, and one of the following, does not exceed unity:
(1)
The sum of the fractions of the inhalation ALI for each radionuclide;
(2)
The total number of derived air concentration-hours (DAC-hours) for all
radionuclides divided by 2,000; or
(3) The sum of the calculated committed effective
dose equivalents to all significantly irradiated organs or tissues (T)
calculated from bioassay data using appropriate biological models and expressed
as a fraction of the annual limit.
(i) The organ or
tissue specified in He-P 4020.06(h)(3) shall be deemed to be significantly
irradiated if, for that organ or tissue, the product of the weighting factors,
WT, and the committed dose equivalent, HT,50, per unit
intake is greater than 10 percent of the maximum weighted value of H50,
that is, WTHT,50, per unit intake for any organ or
tissue.
(j) If the occupationally exposed individual also
receives an intake of radionuclides by oral ingestion greater than 10 percent
of the applicable oral ALI, the licensee or registrant shall account for this
intake and include it in demonstrating compliance with the limits.
(k) A licensee shall evaluate and, to the extent
practical, account for intakes through wounds or skin absorption. The intake through intact skin has been
included in the calculation of DAC for hydrogen-3 and shall not be evaluated or
accounted for pursuant to this paragraph.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.07 Determination of External Dose from
Airborne Radioactive Material.
(a) Licensees or registrants shall, when
determining the dose from airborne radioactive material, include the
contribution to the deep dose equivalent, lens dose equivalent, and shallow
dose equivalent from external exposure to the radioactive cloud.
(b) Airborne radioactivity measurements and DAC
values shall not be used as the primary means to assess the deep dose
equivalent when the airborne radioactive material includes radionuclides other
than noble gases or if the cloud of airborne radioactive material is not
relatively uniform.
(c) The determination of the deep dose equivalent
to an individual shall be based upon measurements using instruments or
individual monitoring devices.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.08 Determination of Internal Exposure.
(a) For purposes of assessing dose used to
determine compliance with occupational dose equivalent limits, the licensee or
registrant shall, when required pursuant to He-P 4022.02, take measurements of:
(1)
Concentrations of radioactive materials in air in work areas;
(2)
Quantities of radionuclides in the body;
(3)
Quantities of radionuclides excreted from the body; or
(4)
Any combinations of these measurements.
(b) Unless respiratory protective equipment is
used, as provided in He-P 4022.08, or the assessment of intake is based on
bioassays, the licensee or registrant shall assume that an individual inhales
radioactive material at the airborne concentration in which the individual is
present.
(c) When specific information on the physical and
biochemical properties of the radionuclides taken into the body or the behavior
of the material in an individual is known, the licensee or registrant may:
(1)
Use that information to calculate the committed effective dose
equivalent;
(2)
Adjust the DAC or ALI values to reflect the actual physical and chemical
characteristics of airborne radioactive material, only if:
a. The licensee or registrant submits the
proposed adjustments to the DHHS/RHS for review;
b. The DHHS/RHS
determines upon its review that the proposed adjustments are technically
correct, appropriately applied, and consonant with the accepted principles and
practices of health physics; and
c. The DHHS/RHS has granted its approval; and
(3)
Separately assess the contribution of fractional intakes of Class D, W,
or Y compounds of a given radionuclide to the committed effective dose
equivalent in accordance with He-P 4090.
(d) If the licensee or registrant uses specific
information on the physical and biochemical properties of radionuclides taken
into the body or the known behavior of material in an individual to calculate
the committed dose equivalent for that individual, then the licensee or
registrant shall document such information in the individual’s record.
(e) If the licensee or registrant chooses to
assess intakes of Class Y material using the measurements given in He-P 4020.08(a)(2) or (3) in order to make additional
measurements basic to the assessments, the licensee or registrant may delay the
recording and reporting of the assessments for periods up to 7 months, unless
otherwise required by He-P 4021.13 or 4021.14.
(f) If the identity and concentration of each
radionuclide in a mixture are known, the fraction of the DAC applicable to the
mixture for use in calculating DAC-hours shall be either:
(1)
The sum of the ratios of the concentration to the appropriate DAC value,
that is, D, W, or Y, from He-P 4090 for each radionuclide in the mixture; or
(2)
The ratio of the total concentration for all radionuclides in the
mixture to the most restrictive DAC value for any radionuclide in the mixture.
(g) If the identity of each radionuclide in a
mixture is known, but the concentration of one or more of the radionuclides in
the mixture is not known, the DAC for the mixture shall be the most restrictive
DAC of any radionuclide in the mixture.
(h) When a mixture of radionuclides in air
exists, a licensee or registrant may disregard certain radionuclides in the
mixture if:
(1)
The licensee or registrant uses the total activity of the mixture in
demonstrating compliance with the dose limits in He-P 4020.05 and in complying
with the monitoring requirements in He-P 4022.02(c);
(2)
The concentration of any radionuclide disregarded is less than 10
percent of its DAC; and
(3)
The sum of these percentages for all of the
radionuclides disregarded in the mixture does not exceed 30 percent.
(i) When determining
the committed effective dose equivalent, the following information may be
considered:
(1) In
order to calculate the committed effective dose equivalent, the licensee may
assume that the inhalation of one ALI, or an exposure of 2,000 DAC-hours,
results in a committed effective dose equivalent of 0.05 Sv
or “5 rem” for radionuclides that have their ALIs or
DACs based on the committed effective dose equivalent;
(2)
The licensee or registrant may use the stochastic ALI to determine
committed effective dose equivalent; and
(3) If
the licensee or registrant uses the stochastic ALI, the licensee or registrant
shall also demonstrate that the limit in He-P 4020.05(a)(1)b. is met.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.09 Determination of Prior Occupational Dose.
(a)
For each individual who is likely to receive,
in a year, an occupational dose requiring monitoring pursuant to He-P 4022.02,
the licensee or registrant shall determine the occupational radiation dose
received during the current year.
(b) Prior to permitting an individual to
participate in a planned special exposure, the licensee or registrant shall
determine:
(1)
The internal and external doses from all previous planned special
exposures; and
(2)
All doses in excess of the limits, including
doses received during accidents and emergencies, received during the lifetime
of the individual.
(c) In complying with the requirements of He-P
4020.09(a) or (b), a licensee or registrant shall:
(1)
Accept, as a record of the occupational dose that the individual
received during the current year, a written signed statement from the
individual, or from the individual’s most recent employer for work involving
radiation exposure, that discloses the nature and the amount of any
occupational dose that the individual received during the current year;
(2)
Accept, as the record of cumulative radiation dose, an up-to-date
DHHS/RHS Form Y or equivalent, containing the following:
a. The full name of the individual monitored for
occupational radiation dose;
b. The monitored individual’s identification
number and identification type;
c. The sex of the monitored individual;
d. The date of birth of the monitored individual
in the format MM/DD/YYYY;
e. The monitoring period for the which the
report is filed, in the format MM/DD/YYYY – MM/DD/YYYY;
f. For each monitoring period reported, the name
of the licensee, registrant, or non-licensed facility that provided monitoring;
g. For each monitoring period reported, the
license or registration number or numbers;
h. For each monitoring period reported, an
indication as to whether the dose data listed represents:
1. A dose record, if the dose data listed is a
final determination of the dose received to the best of the licensee’s
knowledge;
2. A dose estimate, if the listed dose data are
preliminary and will be superseded by a final determination resulting in a
subsequent report. An example of such an instance
shall be dose data based on self-reading dosimeter results and the licensee or
registrant intends to assign the record dose on the basis of
TLD results that are not yet available;
3. No record, if the individual or organization
has indicated that the individual was monitored, but the monitoring records
could not be obtained;
4. A routine exposure, if the data represents
the results of monitoring for routine exposures; and
5. A planned special exposure (PSE), if the data
represents the results of monitoring of planned special exposures. If more than one PSE was received in a single year, the
licensee shall sum them and report the total of all PSEs;
i. For each monitoring period, the following
dose data, in units of rems:
1. The deep dose equivalent (DDE) to the whole
body;
2. The lens dose equivalent (LDE) recorded for
the lens of the eye;
3. The shallow dose equivalent recorded for the
skin of the whole body (SDE,WB);
4. The shallow dose equivalent recorded for the
skin of the extremity receiving the maximum dose (SDE, ME);
5. The committed effective dose equivalent
(CEDE) recorded for the maximally exposed organ;
6. The total effective dose equivalent (TEDE);
and
7. The total organ dose equivalent (TODE) for
the maximally exposed organ;
j. The date and signature of the monitored
individual, certifying that the information contained on the form is complete
and correct to the best of his or her knowledge;
k. Optionally, the name of the licensee or
registrant providing monitoring for exposure to radiation, or the name of the
employer if the individual is not employed by the licensee or registrant and
the employer chooses to maintain exposure records for its employees; and
l. Optionally, the countersignature, and date
signed, of the person designated to represent the most recent licensee,
registrant, or current employer in k. above;
(3)
Obtain reports of the individual’s dose equivalent from the most recent
employer for work involving radiation exposure, or the individual’s current
employer, if the individual is not employed by the licensee or registrant, by
telephone, telegram, facsimile, or letter; and
(4)
Request a written verification of the dose data if the authenticity of
the transmitted report cannot be established.
(d) The licensee or registrant shall record the
exposure history, as required by He-P 4020.09(a) or (b), on DHHS/RHS Form Y, or
equivalent, of all the information required on that form.
(e) The form or record shall show each period in
which the individual received occupational exposure to radiation or radioactive
material and shall be signed by the individual who received the exposure.
(f) For each period for which the licensee or
registrant obtains reports, the licensee or registrant shall use the dose shown
in the report in preparing DHHS/RHS Form Y or equivalent.
(g) For any period in which the licensee or
registrant does not obtain a report, the licensee or registrant shall place a
notation on DHHS/RHS Form Y or equivalent indicating the periods of time for
which data are not available.
(h) Licensees or registrants shall not be
required to reevaluate the separate external dose equivalents and internal
committed dose equivalents or intakes of radionuclides assessed before January
1, 1994.
(i) Occupational
exposure histories obtained and recorded on DHHS/RHS Form Y or equivalent
before January 1, 1994, might not have included effective dose equivalent, but
may be used in the absence of specific information on the intake of
radionuclides by the individual.
(j) If the licensee or registrant is unable to
obtain a complete record of an individual’s current and previously accumulated
occupational dose, the licensee or registrant shall assume:
(1)
That the allowable dose limit for the individual is reduced by 12.5 mSv
(1.25 rem) for each quarter for which records were unavailable and the
individual was engaged in activities that could have resulted in occupational
radiation exposure; and
(2)
That the individual is not available for planned special exposures.
(k) The licensee or registrant shall retain the
records on DHHS/RHS Form Y or equivalent until such time as each pertinent
license or registration requiring this record is terminated in accordance with
this chapter.
(l) The licensee or registrant shall retain
records used in preparing DHHS/RHS Form Y or equivalent for 3 years after the
record is made.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.10 Planned Special Exposures.
(a) A licensee or registrant may authorize an adult
worker to receive doses in addition to and accounted for separately from the
doses received under the limits specified in He-P 4020.05.
(b) This authorization in (a) above shall be
permitted provided that each of the following
conditions is satisfied:
(1)
The licensee or registrant authorizes a planned special exposure only in
an exceptional situation when alternatives that might avoid the higher exposure
are unavailable or impractical;
(2)
The licensee or registrant, and employer if the employer is not the
licensee or registrant, specifically authorizes the planned special exposure,
in writing, before the exposure occurs;
(3)
Before a planned special exposure, the licensee or registrant ensures
that each individual involved is:
a. Informed of the purpose of the planned
operation;
b. Informed of the
estimated doses and associated potential risks and specific radiation levels or
other conditions that might be involved in performing the task; and
c. Instructed in the measures to be taken to
keep the dose ALARA considering other risks that may be present;
(4)
Prior to permitting an individual to participate in a planned special
exposure, the licensee or registrant ascertains prior doses as required by He-P
4020.09(b) during the lifetime of the individual for each
individual involved;
(5)
The licensee or registrant does not authorize a planned special exposure
that would cause an individual to receive a dose from all planned special
exposures and all doses in excess of the limits to
exceed:
a. The numerical values of any of the dose
limits in He-P 4020.05(a) in any year; and
b. Five times the annual dose limits in He-P
4020.05(a) during the individual’s lifetime;
(6)
The licensee or registrant maintains records of the conduct of a planned
special exposure in accordance with He-P 4021.06 and submits a written report
in accordance with He-P 4021.15;
(7)
The licensee or registrant records the best estimate of the dose
resulting from the planned special exposure in the individual’s record and
informs the individual, in writing, of the dose within 30 days from the date of
the planned special exposure; and
(8)
The dose from planned special exposures shall not be considered in
controlling future occupational dose of the individual pursuant to He-P
4020.05(a) but shall be included in evaluations required by He-P 4020.10(b)(4)
and (5).
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.11 Occupational Dose Limits for Minors. The annual occupational dose limits for
minors shall be 10 percent of the annual occupational dose limits specified for
adult workers in He-P 4020.05.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.12 Dose to an Embryo/Fetus.
(a) The licensee or registrant shall ensure that
the dose equivalent to an embryo/fetus during the entire pregnancy, due to
occupational exposure of a declared pregnant woman, does not exceed 5 mSv (0.5
rem).
(b) The licensee or registrant shall make efforts
to avoid substantial variation above a uniform monthly exposure rate to a
declared pregnant woman so as to satisfy the limit in
He-P 4020.12(a).
(c) The dose equivalent to the embryo/fetus shall
be taken as the sum of:
(1)
The deep dose equivalent to the declared pregnant woman; and
(2)
The dose equivalent to the embryo/fetus resulting from radionuclides in
the embryo/fetus and radionuclides in the declared pregnant woman.
(d) If the dose equivalent to the embryo/fetus is
found to have exceeded 4.5 mSv (0.45 rem) by the time the woman declares the
pregnancy to the licensee or registrant, the licensee or registrant shall be
deemed to be in compliance with He-P 4020.12(a) if the
additional dose equivalent to the embryo/fetus does not exceed 0.5 mSv (0.05
rem) during the remainder of the pregnancy.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.13 Dose Limits for Individual Members of the
Public.
(a) Each licensee or registrant shall conduct
operations so that:
(1)
The total effective dose equivalent to individual members of the public
from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a
year, exclusive of the dose contribution from background radiation, from any
medical administration the individual has received, from exposure to
individuals administered radioactive material and released in accordance with
He-P 4035.25, from voluntary participation in medical research programs, and
from the licensee’s disposal of radioactive material into sanitary sewerage in
accordance with He-P 4023.03;
(2)
The dose in any unrestricted area from external sources, exclusive of
the dose contributions from patients administered radioactive material and
released in accordance with He-P 4035.25, does not exceed 0.02 mSv (0.002 rem)
in any one hour; and
(3)
The total effective dose equivalent to individual members of the public
from an exposure to radiation from radiation machines does not exceed 5 mSv
(0.5 rem).
(b) If the licensee or registrant permits members
of the public to have access to controlled areas, the limits for members of the
public continue to apply to those individuals.
(c) Notwithstanding He-P 4020.13(a)(1), a licensee
may permit visitors to an individual who cannot be released under He-P 4035.25,
to receive a radiation dose greater than one mSv (0.1 rem), if
(1)
The radiation dose received does not exceed 5 mSv (0.5 rem); and
(2)
The authorized user, as defined in He-P 4035.03(d), has determined
before the visit that it is appropriate.
(d) A licensee, registrant, or an applicant for a
license or registration shall apply for prior DHHS/RHS authorization, in
accordance with He-P 4030.13, to operate up to an annual dose limit for an
individual member of the public of 5 mSv (0.5 rem).
(e) The applicant for authorization under He-P
4020.13(d) shall provide the following information:
(f) In addition to the requirements of He-P 4020
through He-P 4023, a licensee shall comply with the provisions of the U.S.
Environmental Protection Agency’s generally applicable environmental radiation
standards in 40 CFR 190.
(g) As authorized by, and in accordance with He-P
4030.07, 4030.09, and 4030.13, a licensee shall keep radiation levels in
unrestricted areas ALARA and monitor the total quantity of radionuclides that
the licensee may release in effluents in order to
restrict the collective dose.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4020.14 Compliance with Dose Limits for Individual
Members of the Public.
(a) The licensee or registrant shall make or
cause to be made surveys of radiation levels in unrestricted areas and
controlled areas and radioactive materials in effluents released to
unrestricted areas and controlled areas to demonstrate compliance with the dose
limits for individual members of the public in He-P 4020.13.
(b) A licensee or registrant shall show
compliance with the annual dose limit in He-P 4020.13 by:
a. The annual average concentrations of
radioactive material released in gaseous and liquid effluents at the boundary
of the unrestricted area do not exceed the values specified in He-P 4090, Table
4090.1, Table II; and
b. If an individual were continuously present in
an unrestricted area, the dose from external sources would not exceed 0.02 mSv
(0.002 rem) in an hour and 0.5 mSv (0.05 rem) in a year.
(c) Upon approval from the DHHS/RHS in accordance
with He-P 4030 and He-P 4040, the licensee or registrant may adjust the
effluent concentration values in He-P 4090, Table 4090.1, Table II for members
of the public, to take into account the actual
physical and chemical characteristics of the effluents, such as:
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
PART He-P
4021 RECORDS, REPORTS, AND ADDITIONAL
REQUIREMENTS
Statutory Authority RSA 125-F:5,V
He-P 4021.01 Units and Quantities For
Records
(a) Each licensee or registrant shall use the SI
units becquerel, gray, sievert and coulomb per kilogram, or the special units curie, rad, rem and roentgen, including multiples and
subdivisions, and shall clearly indicate the units of all quantities on records
required by He-P 4020 through 4023.
(b) Notwithstanding the requirements of He-P
4021.01(a), when recording information on shipment manifests, as required in
He-P 4023.06, information shall be recorded in SI units or in SI units and
special units as specified He-P 4021.01(a).
(c) The licensee or registrant shall make a clear
distinction among the quantities entered on the records required by He-P 4020
through 4023, such as:
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.02 Records of Radiation Protection Programs.
(a)
Each licensee or registrant shall maintain records of the radiation
protection program.
(b)
Radiation protection program records shall include:
(c) The licensee or registrant shall retain the
records required by He-P 4021.02(b)(1) until such time as each pertinent
license or registration requiring the record is terminated in accordance with
this chapter.
(d) The licensee or registrant shall retain the
records required by He-P 4021.02(b)(2) for 3 years after the record is made.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.03 Records of Surveys.
(a) Each licensee or registrant shall maintain
records showing the results of surveys and calibrations required by He-P
4022.01 and He-P 4022.16(b).
(b) The licensee or registrant shall retain these
records for 3 years after the record is made.
(c) Until each pertinent license or registration
requiring the record is terminated in accordance with this chapter, the
licensee or registrant shall retain each of the following records:
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.04 Records of Tests for Leakage or
Contamination of Sealed Sources.
Records of tests for leakage or contamination of sealed sources shall be
kept in units of becquerel or microcurie and maintained for inspection by the
DHHS/RHS for 5 years after the records are made.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.05 Records of Prior Occupational Dose.
(a)
The licensee or registrant shall retain the records of prior
occupational dose and exposure history as specified in He-P 4020.09 on DHHS/RHS
Form Y or equivalent until such time as each pertinent license or registration
requiring this record is terminated in accordance with this chapter.
(b)
The licensee or registrant shall retain records used in preparing
DHHS/RHS Form Y or equivalent as specified in He-P 4020.09(c)(2) for 3 years
after the record is made.
(c) Upon termination of the license or
registration, the licensee or registrant shall permanently store records on
DHHS/RHS Form Y or equivalent as specified in He-P 4020.09(c)(2), or shall make
provisions with the DHHS/RHS for transfer to the DHHS/RHS.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.06 Records of Planned Special Exposures.
(a)
For each use of the provisions of He-P 4020.10 for planned special
exposures, the licensee or registrant shall maintain records that describe:
(b) The licensee or registrant shall retain the
records until such time as each pertinent license or registration requiring
these records is terminated in accordance with this chapter.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.07 Records of Individual Monitoring Results.
(a) Each licensee or registrant shall maintain
records of doses received by all individuals for whom monitoring was required
pursuant to He-P 4022.02, and records of doses received during planned special
exposures, accidents, and emergency conditions.
(b) Assessments of dose equivalent and records
made using units in effect before August 6, 1998, shall not have to be changed.
(c) The records specified in He-P 4021.07(a)
shall include, when applicable:
(d) The licensee or registrant shall make entries
of the records specified in He-P 4021.07(a) at intervals not to exceed one
year.
(e) The licensee or registrant shall maintain the
records specified in He-P 4021.07(a) on DHHS/RHS Form Z, or equivalent
containing the following:
a. A dose record, if the dose data listed is a
final determination of the dose received to the best of the licensee’s
knowledge;
b. A dose estimate, if the listed dose data are
preliminary and will be superseded by a final determination resulting in a
subsequent report. An example of such an instance
shall be dose data based on self-reading dosimeter results and the licensee
intends to assign the record dose on the basis of TLD
results that are not yet available;
c. A routine exposure,
if the data represents the results of monitoring for routine exposures;
and
d. A planned special exposure (PSE), if the data
represents the results of monitoring of planned special exposures. If more than one PSE was received in a single year, the
licensee or registrant shall sum them and report the total of all PSEs;
a. The deep dose equivalent (DDE) to the whole
body;
b. The lens dose equivalent (LDE) recorded for
the lens of the eye;
c. The shallow dose equivalent recorded for the
skin of the whole body (SDE,WB);
d. The shallow dose equivalent recorded for the
skin of the extremity receiving the maximum dose (SDE, ME);
e. The committed effective dose equivalent
(CEDE) recorded for the maximally exposed organ, or
“NR” for “Not Required” or “NC” for “Not Calculated”;
f. The total effective dose equivalent (TEDE);
and
g. The total organ dose equivalent (TODE) for
the maximally exposed organ;
(f) The licensee or registrant shall maintain the
records of dose to an embryo/fetus with the records of dose to the declared
pregnant woman.
(g) The declaration of pregnancy, including the
estimated date of conception, shall also be kept on file, but may be maintained
separately from the dose records.
(h) The licensee or registrant shall retain each
required form or record until such time as each pertinent license or
registration requiring the record is terminated in accordance with this
chapter.
(i) The records
required under this section shall be protected from public disclosure, under
the authority of RSA 91-A:5, and the Privacy Act of 1974, Public Law 93-579, 5
U.S.C. 552a, because of their personal privacy nature.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.08 Records of Dose to Individual Members of
the Public.
(a) Each licensee or registrant shall maintain
records to demonstrate compliance with the dose limit for individual members of
the public.
(b) The licensee or registrant shall retain the
records required by He-P 4021.08(a) until such time as each pertinent license
or registration requiring the record is terminated in accordance with this
chapter.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.09 Records of Waste Disposal.
(a) Each licensee shall maintain records of the
disposal of licensed materials made pursuant to He P
4023.02, He-P 4023.03, He-P 4023.04, He-P 4023.05, and He-P 4062.
(b) The records of disposal required by (a) above
shall include as a minimum:
(c) The licensee shall retain the records
required by (a) above until such time as each pertinent license requiring the
record is terminated in accordance with this chapter.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.10 Records of Testing Entry Control Devices
for Very High Radiation Areas:
Irradiators.
(a) Each licensee or registrant shall maintain
records of tests made pursuant to He-P 4022.06(c)(9) on entry control devices
for very high radiation areas.
(b) These records shall include the date, time,
and results of each such test of function.
(c) The licensee or registrant shall retain the
records required by (a) above for 3 years after the record is made.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.11 Form of Records.
(a) Each record required by He-P
4020 - 4023 shall be legible throughout the specified retention period.
(b) The record shall be the original or a
reproduced copy or a microform, provided that the copy or microform is
authenticated by authorized personnel and that the microform is
capable of producing a clear copy throughout the required retention
period.
(c) The record may also be stored in electronic
media with the capability for producing legible, accurate, and complete records
during the required retention period.
(d) Records, such as letters, drawings, and
specifications, shall include all pertinent information, such as stamps,
initials, and signatures.
(e) The licensee shall maintain safeguards
against tampering with and loss of records.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.12 Reports of Stolen, Lost, or Missing
Licensed or Registered Sources of Radiation.
(a)
Each licensee or registrant shall report stolen, lost, or missing
licensed or registered sources of radiation to the DHHS/RHS by telephone.
(b)
Reports shall be made as follows:
(c) Each licensee or registrant required to make
a report pursuant to He-P 4021.12 shall, within 30 days after making the
telephone report, make a written report to the DHHS/RHS.
(d) Reports shall contain:
(a) For radioactive material, the kind, quantity,
and chemical and physical form; and
(b) For radiation machines, the manufacturer,
model and serial number, type and maximum energy of radiation emitted;
(e) Subsequent to filing the written report, the
licensee or registrant shall also report additional information on the loss or
theft within 30 days after the licensee or registrant learns of such
information.
(f) The licensee or registrant shall prepare any
report filed with the DHHS/RHS pursuant to He-P 4021.12 so that names of
individuals who may have received exposure to radiation are stated in a
separate and detachable portion of the report.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.13 Notification of Incidents.
(a) Notwithstanding other requirements for
notification, each licensee or registrant shall immediately report to the
DHHS/RHS by telephone each event involving a source of radiation possessed by
the licensee or registrant that may have caused or threatens to cause any of
the following:
a. A total effective dose equivalent of 0.25 Sv or “25 rems” or more;
b. A lens dose equivalent of 0.75 Sv or “75 rems” or more; or
c. A shallow dose equivalent to the skin or
extremities or a total organ dose equivalent of 2.5 Gy
or “250 rads” or more; or
(b) The provision in He-P 4021.13(a)(2) shall not
apply to locations where personnel are not normally stationed during routine
operations, such as hot-cells or process enclosures.
(c) Each licensee or registrant shall, within 24
hours of discovery of the event, report to the DHHS/RHS by telephone each event
involving loss of control of a licensed or registered source of radiation
possessed by the licensee or registrant that may have caused, or threatens to
cause, any of the following:
a. A total effective dose equivalent exceeding
0.05 Sv or “5 rems”;
b. A lens dose equivalent exceeding 0.15 Sv or “15 rems”; or
c. A shallow dose equivalent to the skin or
extremities or a total organ dose equivalent exceeding 0.5 Sv
or “50 rems”; or
(d) The provision in (c)(2) above shall not apply
to locations where personnel are not normally stationed during routine
operations, such as hot-cells or process enclosures.
(e) The licensee or registrant shall prepare each
report filed with the DHHS/RHS pursuant to He-P 4021.13 so that names of
individuals who have received exposure to sources of radiation are stated in a
separate and detachable portion of the report.
(f) Reserved.
(g) The provisions of He-P
4021.13 shall not apply to doses that result from planned special exposures,
provided such doses are within the limits for planned special exposures and are
reported pursuant to He-P 4021.15.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.14 Reports of Exposures, Radiation Levels,
and Concentrations of Radioactive Material Exceeding the Limits.
(a) In addition to the notification required by
He-P 4021.13, each licensee or registrant shall submit a written report within
30 days after learning of any of the following occurrences:
a. The occupational dose limits for adults in He‑P
4020.05;
b. The occupational dose limits for a minor in
He‑P 4020.11;
c. The limits for an embryo/fetus of a declared
pregnant woman in He-P 4020.12;
d. The limits for an individual member of the
public in He-P 4020.13;
e. Any applicable limit in the license or
registration; or
f. The ALARA constraints for air emissions
established under He-P 4020.04(d);
a. A restricted area in excess
of applicable limits in the license or registration; or
b. An unrestricted area in
excess of 10 times the applicable limit set forth in He-P 4020 or in the
license or registration, whether or not involving exposure of any individual in
excess of the limits in He-P 4020.13; or
(b) Contents of Reports.
a. Estimates of each
individual’s dose;
b. The levels of radiation and concentrations of
radioactive material involved;
c. The cause of the elevated exposures, dose
rates, or concentrations; and
d. Corrective steps taken or planned to ensure
against a recurrence, including the schedule for achieving conformance with
applicable limits, ALARA constraints, generally
applicable environmental standards, and associated license or registration
conditions;
a. The name;
b. Social security number, as authorized by 10
CFR 20.2203(b)(2); and
c. Date of birth;
(c) All licensees or registrants who make reports
pursuant to (a) above shall submit the report in writing to the DHHS/RHS.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.15 Reports of Planned Special Exposures. The licensee or registrant shall submit a
written report to the DHHS/RHS within 30 days following any planned special
exposure conducted in accordance with He-P 4020.10, informing the DHHS/RHS that
a planned special exposure was conducted and indicating the date the planned
special exposure occurred and the information required by He-P 4021.06.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.16 Report to
Individuals of Exceeding Dose Limits.
When a licensee or registrant is required pursuant to He-P 4021.14 or
He-P 4021.15 to report to the DHHS/RHS any exposure of an identified
occupationally exposed individual, or an identified member of the public, to
radiation or radioactive material, the licensee or registrant shall also
provide a copy of the report submitted to the DHHS/RHS to the individual, and
such report shall be transmitted at a time no later than the transmittal to the
DHHS/RHS.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.17 Reports of Individual Monitoring.
(a) This section applies to each person licensed
or registered by the DHHS/RHS to:
Table 4021.1
Radionuclide
|
Activity
|
|
|
Ci |
GBq
|
Cesium-137 |
1 |
37 |
Cobalt-60 |
1 |
37 |
Gold-198 |
100 |
3,700 |
Iodine-131 |
1 |
37 |
Iridium-192 |
10 |
370 |
Krypton-85 |
1,000 |
37,000 |
Promethium-147 |
10 |
370 |
Technetium-99m |
1,000 |
37,000 |
(b) Each licensee or registrant in a category
listed in (a) above shall submit an annual report of the results of individual
monitoring carried out by the licensee or registrant for each
individual for whom monitoring was required by He-P 4022.02 during that
year, and that may include additional data for individuals for whom monitoring
was provided but not required.
(c) The licensee or registrant shall use DHHS/RHS
Form Z or equivalent as specified in He-P 4021.07(e) containing all the
information required by DHHS/RHS Form Z for filing the annual report described
in (b) above.
(d) The licensee or registrant shall file the
report required by (b) above, covering the preceding year, on or before April
30 of each year, and the licensee or registrant shall submit the report to the
DHHS/RHS.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.18 Notifications and Reports to Individuals.
(a) Requirements for notification and reports to
individuals of exposure to radiation or radioactive material shall be as
specified in He-P 4019.05.
(b) When a licensee or registrant is required
pursuant to He-P 4021.14 to report to the DHHS/RHS any
exposure of an individual to radiation or radioactive material, the licensee or
registrant shall also notify the individual.
(c) Such notice shall be transmitted at a time
not later than the transmittal to the DHHS/RHS and shall comply with the
provisions of He-P 4019.05.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.19 Reports of Leaking or Contaminated Sealed
Sources.
(a) The licensee or registrant shall file a
report within 5 days with the DHHS/RHS if the test for leakage or contamination
required by He-P 4001.05 indicates a sealed source is
leaking or contaminated.
(b) The report shall include:
(1) The equipment involved;
(2) The test results; and
(3) The corrective action taken.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.20 Additional Requirements.
(a) Each specific licensee shall, no less than 30
days before vacating or relinquishing possession or control of premises which
may have been contaminated with radioactive material as a
result of licensee’s activities, notify the DHHS/RHS in writing of
intent to vacate.
(b) If in the course of a survey as required by He-P 4022.01, a licensee should find a surface
contaminated to levels in excess of the values specified in Table 4021.2,
Column 1, the licensee shall immediately institute measures to reduce the
contamination to the levels specified.
(c) No licensee shall allow surfaces or surfaces
of objects contaminated to levels in excess of the
values specified in Table 4021.2 to be released to unrestricted areas.
(d) Where surface contamination by both alpha and
beta-gamma emitting isotopes exists, the limits established for alpha and
beta-gamma emitting isotopes shall apply independently.
(e) The radioactivity on the interior surfaces of
pipes, drain lines or ductwork shall be determined by making measurements at
all traps and other appropriate access points to the interior of the pipes,
drain lines or ductwork.
(f) Surfaces of premises, equipment or scrap that
may be contaminated and that are of such size, construction
or location as to make the surface inaccessible for purposes of measurement,
shall be presumed to be contaminated in excess of the levels.
(g) The amount of removable radioactive material
per 100 square centimeters (cm2) of surface area shall be determined by wiping
that area, with dry filter or soft absorbent paper and with the application of
moderate pressure, and assessing the amount of radioactive material on the wipe
with an appropriate instrument of known efficiency.
(h) For objects of lesser than 100 cm2 surface
area, the entire surface shall be wiped and the above
levels reduced in direct proportion to the area of the object.
(i) Measurements of
fixed contaminant shall not be averaged over more than 1.0 square meter.
(j) For objects of lesser than 1.0 square meter
area, the average shall be derived from measurements made on each of the
surfaces of the object.
(k) Disintegrations per minute (dpm) shall be determined by correcting the counts per
minute observed by an appropriate detector and count rate meter, for
background, efficiency, and geometric factors associated with the
instrumentation.
(l) Fixed beta-gamma contamination levels shall
be measured through not more than 7 milligrams per square centimeter of total
absorber.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.21 Permissible Levels of Surface
Contamination. Levels of surface
contamination shall be in compliance with the
restrictions set forth in Table 4021.2 below:
|
Fixed |
Removable |
|
Nuclide |
Average |
Maximum |
|
U-natural,
U-235, U-238 and associated decay products |
|
|
|
Transuranics, Ra-226,
Ra-228, Th-230, Th-228, Pa-231, Ac-227, I-125, I-129 |
|
|
|
Th-nat, Th-232, Sr-90, Ra-223, Ra-224, U-232, I-126, I-131,
I-133 |
|
|
|
Beta-gamma
emitters (nuclides with decay modes other than alpha emission or spontaneous
fission except Sr-90 and others noted above). |
|
|
|
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8481, eff 11-5-05; ss by #10604, eff 5-23-14
He-P 4021.22 Reports of Transactions Involving
Nationally Tracked Sources. Each licensee
who manufactures, transfers, receives, disassembles, or disposes of a
nationally tracked source shall complete and submit a National Source Tracking
Transaction Report as specified in He-P 4021.22(a) through (e) below for each
type of transaction.
(a) Each licensee who manufactures a nationally
tracked source shall complete and submit a National Source Tracking Transaction
Report by using the Nuclear Regulatory Commission (NRC) “Form 748” or by
submitting the following information by using the NRC’s web-based online
reporting system:
(1) The name, address, and license number of the
reporting licensee;
(2) The name of the individual preparing the
report;
(3) The manufacturer, model, and serial number of
the source;
(4) The radioactive material in the source;
(5) The initial source strength in becquerels or
in curies, at the time of manufacture; and
(6) The manufacture date of the source.
(b) Each licensee that transfers a nationally
tracked source to another person shall complete and submit a National Source
Tracking Transaction Report, to include the following information:
(1) The name, address, and license number of the
reporting licensee;
(2) The name of the individual preparing the
report;
(3) The name and license number of the recipient
facility and the shipping address;
(4) The manufacturer, model, and serial number of
the source or, if not available, other information to uniquely identify the
source;
(5) The radioactive material in the source;
(6) The initial or current source strength in
becquerels or in curies;
(7) The date for which the source strength is
reported;
(8) The shipping date;
(9) The estimated arrival date; and
(10) For nationally tracked sources transferred as
waste under a uniform low-level radioactive waste manifest, the waste manifest number and the container identification of the container
with the nationally tracked source.
(c) Each licensee that receives a nationally tracked source shall complete and
submit a National Source Tracking Transaction Report, to include the following information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The name, address, and license number of the person that provided the source;
(4) The manufacturer, model, and serial number of the source or, if not available, other
information to uniquely identify the source;
(5) The radioactive material in the source;
(6) The initial or current source strength in becquerels, also known as curies;
(7) The date for which the source
strength is reported;
(8) The date of receipt; and
(9) For material received under a
uniform low-level radioactive waste manifest, the waste manifest number and the container
identification with the nationally tracked source.
(d) Each licensee that disassembles
a nationally tracked source shall complete and submit a National Source Tracking Transaction Report,
to include the following information:
(1) The name, address, and license number of the reporting licensee;
(2) The name of the individual
preparing the report;
(3) The manufacturer, model, and serial number of the source or, if not
available, other information to uniquely identify the source;
(4) The radioactive material in the source;
(5) The initial or current source strength in becquerels, also known as curies;
(6) The date for which the source strength is reported; and
(7) The disassemble date of the source.
(e) Each licensee who disposes of a
nationally tracked source shall complete and submit a National Source Tracking Transaction Report,
to include the following information:
(1) The name, address, and license
number of the reporting licensee;
(2) The name of the individual preparing the report;
(3) The waste manifest number;
(4) The container identification with the nationally tracked source;
(5) The date of disposal; and
(6) The method of disposal.
(f) The reports in (a) through (e) above:
(1) Shall be submitted by the close
of the next business day after the transaction;
(2) May be submitted in a single report for multiple sources and transactions; and
(3) Shall be submitted to the
National Source Tracking System (NSTS) by using:
a. The online NSTS;
b. Electronically using a computer-readable format;
c. By facsimile;
d. By e-mail;
e. By postal mail to the address found
on the NRC form entitled “NRC Form 748”; or
f. By telephone with follow up by facsimile or postal mail.
(g) Each licensee shall correct any
error in previously filed reports or file a new report for any missed
transaction within 5 business days of the discovery of the error or missed transaction. Such
errors may be detected by a variety of methods such as administrative reviews
or by physical inventories required by regulation. In addition:
(1) Each licensee shall reconcile
the inventory of nationally tracked sources possessed by the licensee against that licensee’s data in the NSTS;
(2) The reconciliation shall be conducted during the month of January in each year; and
(3) The reconciliation process shall
include resolving any discrepancies between the NSTS and the actual inventory
by filing the reports identified by He-P 4021.22(a) through (e) above. By
January 31 of each year, each licensee shall submit to the NSTS confirmation
that the data in the NSTS is correct.
Source. #10604, eff 5-23-14;
ss by #13597, eff 3-24-23
PART He-P 4022 SURVEYS AND
MONITORING
He-P 4022.01 General.
(a) Each licensee or registrant shall make, or
cause to be made, surveys of areas, including the subsurface that:
(1) Are necessary for the licensee or registrant
to comply with He-P 4020 through He-P 4023; and
(2) Are necessary to evaluate:
a. The magnitude and extent of radiation levels;
b. Concentrations or quantities of residual
radioactivity; and
c. The potential radiological hazards of the
radiation levels and residual radioactivity detected.
(b) Notwithstanding He-P 4021.03(a), records from
surveys describing the locations and amount of subsurface residual
radioactivity identified at the site shall be kept with records important for decommissoning, and such records shall be retained in
accordance with He-P 4030.09(r).
(c) The licensee or registrant shall ensure that
instruments and equipment used for quantitative radiation measurements are
calibrated at intervals not to exceed 12 months for the radiation measured,
except when a more frequent interval is specified in another applicable part of
this chapter or in a license condition.
(d) All personnel dosimeters, except for direct
and indirect reading pocket ionization chambers and those dosimeters used to
measure the dose to any extremity, that require processing to determine the
radiation dose and that are used by licensees and registrants to comply with
He-P 4020.05, with other applicable provisions of this chapter, or with
conditions specified in a license or registration, shall be processed
and evaluated by a dosimetry processor:
(1) Holding current personnel dosimetry
accreditation from the National Voluntary Laboratory Accreditation Program
(NVLAP) of the National Institute of Standards and Technology; and
(2) Approved in this accreditation process for
the type of radiation or radiations included in the NVLAP program that most
closely approximates the type of radiation or radiations for which the
individual wearing the dosimeter is monitored.
(e) The licensee or registrant shall ensure that
adequate precautions are taken to prevent a deceptive exposure of an individual
monitoring device.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4022.02 Conditions
Requiring Individual Monitoring of External and Internal Occupational Dose.
(a) Each licensee or registrant shall monitor
occupational exposures from licensed and unlicensed sources of radiation at
levels sufficient to demonstrate compliance with the occupational dose limits
of He-P 4020 through He-P 4023.
(b) As a minimum, each licensee or registrant
shall monitor occupational exposure to radiation from licensed and unlicensed
radiation sources under its control and shall supply and require the use of
individual monitoring devices by:
(1) Adults likely to receive, in one year from
sources external to the body, a dose in excess of 10
percent of the limits in He-P 4020.05(a);
(2) Minors likely to receive, in one year from
sources external to the body, a deep dose equivalent in
excess of 1 mSv (0.1 rem), a lens dose equivalent in excess of 1.5 mSv
(0.15 rem), or a shallow dose equivalent to the skin or to the extremities in
excess of 5 mSv (0.5 rem);
(3) Declared pregnant women likely to receive
during the entire pregnancy, from radiation sources external to the body, a
deep dose equivalent in excess of 1 mSv ,0.1 rem);
(4) Individuals entering a high or very high
radiation area; and
(5) Individuals working with medical fluoroscopic
equipment.
(c) To determine compliance with He-P 4020.08,
each licensee or registrant shall monitor the occupational intake of
radioactive material by, and assess the committed effective dose equivalent to:
(1) Adults likely to receive, in one year, an
intake in excess of 10 percent of the applicable ALI in Table 4090.1, Table I,
Columns 1 and 2, of He-P 4090;
(2) Minors likely to receive, in one year, a
committed effective dose equivalent in excess of 1 mSv
(0.1 rem); and
(3) Declared pregnant women likely to receive,
during the entire pregnancy, a committed dose equivalent in
excess of 1 mSv (0.1 rem).
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4022.03 Location of Individual Monitoring Devices.
(a) Each licensee or registrant shall ensure that
individuals who are required to monitor occupational doses in accordance with
He-P 4022.02(a) wear monitoring devices.
(b) Individual monitoring devices shall be worn
as follows:
(1) An individual monitoring device used for
monitoring the dose to the whole body shall be worn at the unshielded location
of the whole body likely to receive the highest exposure;
(2) When a protective apron is worn, the location
of the individual monitoring device shall be at the neck;
(3) An individual monitoring device used for
monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant
to He-P 4020.12(a), shall be located under the protective apron at the waist;
(4) An individual monitoring device used for
monitoring the lens dose equivalent, in accordance with He-P 4020.05(a)(2), a.,
shall be located:
a. At the neck and outside the protective apron
if being worn by the monitored individual; or
b. At an unshielded location close to the eye;
(5) An individual monitoring device used for
monitoring the dose to the extremities, in accordance with He-P 4020.05(a)(2),
b., shall be worn on the extremity likely to receive the highest exposure;
(6) Each individual monitoring device used in
accordance with He-P 4022.03(b)(5) shall be oriented to measure the highest
dose to the extremity being monitored;
(7) One individual monitoring device used to
determine the effective dose equivalent for external radiation pursuant to He-P
4020.05(g) and He-P 4022.02(b)(5), shall be located at the neck outside the
protective apron;
(8) If two individual monitoring devices are used
to determine the effective dose equivalent for external radiation pursuant to He-P 4020.05(g) and He-P 4022.02(b)(5), they shall be
located:
a. One at the neck outside the protective apron;
and
b. One under the protective apron at the waist;
and
(9) Two individual monitoring devices shall be
used and worn in accordance with He-P 4022.03(b)(8) by declared pregnant woman.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4022.04 Control of Access to High Radiation Areas.
(a) The licensee or registrant shall ensure that
each entrance or access point to a high radiation area has one or more of the
following features:
(1) A control device that, upon entry into the
area, causes the level of radiation to be reduced below that level at which an
individual might receive a deep dose equivalent of one mSv (0.1 rem) in one
hour at 30 centimeters from the source of radiation or from any surface that
the radiation penetrates;
(2) A control device that energizes a conspicuous
visible or audible alarm signal so that the individual entering the high
radiation area and the supervisor of the activity are made aware of the entry;
or
(3) Entryways that are locked, except during
periods when access to the areas is required, with positive control over each
individual entry.
(b) In place of the controls
required by He-P 4022.04(a) for a high radiation area, the licensee or
registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
(c) The licensee or registrant may apply to
DHHS/RHS in writing for approval of alternative methods for controlling access
to high radiation areas.
(d) The licensee or registrant shall establish
the controls required by He-P 4022.04(a) and (c) in a way that does not prevent
individuals from leaving a high radiation area.
(e) The licensee or registrant shall not be
required to control each access point to an area that is a high radiation area
solely because of the presence of radioactive materials prepared for transport,
packaged and labeled in accordance with He-P 4037
provided that:
(1) The packages do not remain in the area longer
than 3 days; and
(2) The dose rate at one meter from the external
surface of any package does not exceed 0.1 mSv (0.01 rem) per hour.
(f) The licensee or registrant shall not be
required to control entrance or access to rooms or other areas in hospitals
solely because of the presence of patients containing radioactive material,
provided that:
(1) There are personnel in attendance who are
taking the necessary precautions to prevent the exposure of individuals to
radiation or radioactive material in excess of the
established limits in He-P 4020 through He-P 4023; and
(2) The licensee’s or registrant’s radiation
protection program operates within the provisions of ALARA.
(g) The registrant shall not be required to
control entrance or access to rooms or other areas containing sources of
radiation capable of producing a high radiation area as described in He-P
4022.04 if the registrant has met all the specific requirements for access and
control specified in other applicable parts of these rules.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.05 Control of Access to Very High Radiation
Areas.
(a) In addition to the requirements in He-P
4022.04, the licensee or registrant shall institute measures to ensure that an
individual is not able to gain unauthorized or inadvertent access to areas in
which radiation levels could be encountered at 5 Gy,
(500 rad) or more in one hour at one meter from a source of radiation or any
surface through which the radiation penetrates.
(b) He-P 4022.05(a) does not apply to rooms or
areas in which diagnostic x-ray systems are the only source of radiation, or to
non-self-shielded irradiators.
(c) The registrant shall not be required to
control entrance or access to rooms or other areas containing sources of
radiation capable of producing a very high radiation area as described in He-P
4022.05(a) if the registrant has met all the specific requirements for access
and control specified in:
(1) He-P 4034 and 4042 for industrial
radiography;
(2) He-P 4040 and 4041 for x-rays in the healing
arts; and
(3) He-P 4044 for particle accelerators.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.06 Control of Access to Very High Radiation
Areas; Irradiators.
(a) This section shall apply to licensees or
registrants with sources of radiation in non-self-shielded irradiators.
(b) This section shall not apply to sources of
radiation that are used:
(1) In teletherapy;
(2) In industrial radiography; or
(3) In completely self-shielded irradiators in
which the source of radiation is both stored and operated within the same
shielding radiation barrier and, in the designed configuration of the
irradiator, is always physically inaccessible to any individual and cannot
create high levels of radiation in an area that is accessible to any
individual.
(c) Each area in which there may exist radiation
levels in excess of 5 Gy
(500 rad) in one hour at one meter from a source of radiation that is used to
irradiate materials shall meet the following requirements:
(1) Each entrance or access point shall be
equipped with entry control devices which shall:
a. Function automatically to prevent any
individual from inadvertently entering a very high radiation area;
b. Permit deliberate entry into the area only
after a control device is actuated that causes the radiation level within the
area, from the source of radiation, to be reduced below that at which it would
be possible for an individual to receive a deep dose equivalent in excess of one mSv (0.1 rem) in one hour; and
c. Prevent operation of the source of radiation
if it would produce radiation levels in the area that could result in a deep
dose equivalent to an individual in excess of one mSv
(0.1 rem) in one hour;
(2) Upon failure of the entry control devices to
function as required by He-P 4022.06(c)(1), additional control devices shall be
provided so that:
a. The radiation level within the area, from the
source of radiation, shall be reduced below that at which it would be possible
for an individual to receive a deep dose equivalent in excess
of one mSv (0.1 rem) in one hour; and
b. Conspicuous visible and audible alarm signals
shall be generated to make:
1. An individual attempting to enter the area
aware of the hazard; and
2. At least one other authorized individual, who
is physically present, familiar with the activity, prepared to render or summon
assistance, and is aware of the failure of the entry control devices;
(3) Upon failure or removal of physical radiation
barriers other than a sealed source’s shielded storage container, the licensee
or registrant shall provide control devices so that:
a. The radiation level from the source of
radiation shall be reduced below that at which it would be possible for an
individual to receive a deep dose equivalent in excess of
one mSv (0.1 rem) in one hour; and
b. Conspicuous visible and audible alarm signals
shall be generated to make:
1. Potentially affected individuals aware of the
hazard; and
2. The licensee or registrant or at least one
other individual, who is familiar with the activity and prepared to render or
summon assistance, aware of the failure or removal of the physical barrier;
(4) When a shield for stored sealed sources is a
liquid, the licensee or registrant shall provide means to monitor the integrity
of the shield and to signal, automatically, loss of adequate shielding;
(5) Physical radiation barriers that comprise
permanent structural components, such as walls, that have no credible
probability of failure or removal in ordinary circumstances shall not need to
meet the requirements of He-P 4022.06(c)(3) and (4);
(6) Each area shall be equipped with devices that
automatically generate conspicuous visible and audible alarm signals to:
a. Alert personnel in the area before the source
of radiation can be put into operation; and
b. Allow time for any individual in the area to
operate a clearly identified control device, which:
1. Shall be installed in the area; and
2. Shall prevent the source of radiation from
being put into operation when the control device is actuated;
(7) Each area shall be controlled
by use of such administrative procedures and such devices as are necessary to
ensure that the area is cleared of personnel prior to each use of the source of
radiation;
(8) Each area shall be checked by a radiation
measurement prior to the first individual’s entry into the area and after any
use of the source of radiation to ensure that the radiation level from the
source of radiation in the area is below that at which it would be possible for
an individual to receive a deep dose equivalent in excess of
one mSv (0.1 rem) in one hour;
(9) The entry control devices
required in He-P 4022.05(c)(1) shall be tested for proper functioning:
a. Prior to initial operation with the source of
radiation on any day, unless operations were continued uninterrupted from the
previous day; and
b. Prior to resumption of operation of the
source of radiation after any unintentional interruption;
(10) The licensee or registrant shall adhere to
and submit to DHHS/RHS a schedule for periodic tests of the entry control and
warning systems;
(11) The licensee or registrant shall not conduct
operations, other than those necessary to place the source of radiation in safe
condition or to effect repairs on controls, unless control devices are
functioning properly;
(12) Entry and exit portals that are used in
transporting materials to and from the irradiation area, and that are not
intended for use by individuals, shall be controlled by such devices and
administrative procedures as are necessary to physically protect and warn
against inadvertent entry by any individual through these portals; and
(13) Exit portals for irradiated materials shall
be equipped to detect and automatically signal the presence of any loose
radioactive material that is carried toward such an exit to prevent loose
radioactive material from being carried out of the area.
(d) Licensees, registrants, or applicants for
licenses or registrations for sources of radiation within the purview of He-P
4022.06(c) which will be used in a variety of positions or in locations that
make it impracticable to comply with certain requirements of He-P 4022.06(c)
may apply to DHHS/RHS for approval of alternative safety measures.
(e) Alternative safety measures shall:
(1) Provide personnel protection at least
equivalent to those specified in He-P 4022.06(c); and
(2) Have at least one of the alternative measures
to include an entry-preventing interlock control based on a measurement of the
radiation that ensures the absence of high radiation levels before an
individual can gain access to the area where such sources of radiation are
used.
(f) The entry control devices required by He-P
4022.06(c) and (d) shall not prevent an individual from leaving the area.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.07 Control of Radioactive Material in the Air.
(a) The licensee shall use, to the extent
practicable, process or other engineering controls, such as containment,
decontamination, or ventilation, to control the concentrations of radioactive
material in air.
(b) When it is not practicable to
apply process or other engineering controls to control the concentrations of
radioactive material in air to values below those that define an airborne
radioactivity area, the licensee or registrant shall, consistent with
maintaining the total effective dose equivalent, as low as is reasonably
achievable (ALARA), increase monitoring and limit intakes by one or more of the
following means:
(1) Control of access;
(2) Limitation of exposure times;
(3) Use of respiratory protection equipment; or
(4) Other controls.
(c) If the licensee performs an ALARA analysis to
determine whether or not respirators should be used, the licensee may also consider the
impact of respirator use of workers’ industrial health and safety.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4022.08 Use of Individual Respiratory Protection
Equipment.
(a) If the licensee assigns or permits the use of
respiratory protection equipment to limit intakes pursuant to
He-P 4022.07, the licensee or registrant shall:
(1) Except as provided in He-P 4022.08(a)(2), use
only respiratory protection equipment that is tested and certified or had
certification extended by the National Institute for Occupational Safety and
Health (NIOSH);
(2) Submit an application
to DHHS/RHS for authorized use of equipment which:
a. Has not been tested or certified by NIOSH; or
b. Has no schedule for testing or certification;
(3) Include in the application specified in He-P
4022.08(a)(2) above a demonstration by testing, or a demonstration on the basis of reliable test information, that the material
and performance characteristics of the equipment are capable of providing the
proposed degree of protection under anticipated conditions of use;
(4) Implement and maintain a respiratory
protection program that includes:
a. Air sampling sufficient to identify the
potential hazard, permit proper equipment selection, and estimate doses;
b. Surveys and bioassays, as appropriate, to
evaluate actual intakes;
c. Testing of respirators for operability,
including user seal check for face sealing devices and functional checks for
other devices, immediately prior to each use;
d. Written procedures regarding:
1. Supervision and training of respirator users;
2. Monitoring, including air sampling and
bioassays;
3. Fit testing;
4. Respirator selection;
5. Breathing air quality;
6. Inventory and control;
7. Storage, issuance, maintenance, repair,
testing, and quality assurance of respiratory protection equipment;
8. Record-keeping; and
9. Limitations on periods of respiratory use and
relief from respirator use;
e. A determination by a physician that the
individual user is medically fit to use the respiratory protection equipment
prior to:
1. The initial fitting of a face-sealing
respirator:
2. The first field use of non-face-sealing
respirators; and
3. Either every 12 months thereafter, or
periodically at a frequency determined by a physician; and
f. Fit testing, performed with the facepiece
operating in the negative pressure mode, with a fit factor greater than 10
times the assigned protection factor (APF) for negative pressure devices, and a
fit factor greater than 500 times the APF for any positive pressure, continuous
flow, and pressure-demand devices, before the first field use of tight fitting,
face sealing respirators, and periodically thereafter at a frequency not to
exceed one year;
(5) Issue a written policy statement on
respirator usage covering:
a. The use of process or other engineering
controls, instead of respirators;
b. The routine, non-routine, and emergency use
of respirators; and
c. The length of periods of respirator use and relief from respirator use;
(6) Advise each respirator user that the user may
leave the area at any time for relief from respirator use in the event of:
a. Equipment malfunction;
b. Physical or psychological distress;
c. Procedural or communication failure;
d. Significant deterioration of operating
conditions; or
e. Any other conditions that might require such
relief;
(7) Use respiratory protection
equipment within the equipment manufacturer’s expressed limitations for type
and mode of use and shall provide vision correction, adequate communication,
low temperature work environments, and the concurrent use of other safety or
radiological protection equipment;
(8) Use safety, radiological protection
or other equipment in such a way as not to interfere with the proper operation
of the respirator;
(9) Provide standby rescue personnel whenever
one-piece atmosphere-supplying suits, or any combination of supplied air
respiratory protection device and personnel protective equipment are used from
which an unaided individual would have difficulty extricating himself or
herself, with the following:
a. Respiratory protection devices or other
apparatus appropriate for the potential hazards;
b. Continuous communication with the workers, by
one or more of the following methods:
1. By sight;
2. By voice;
3. By signal line;
4. By telephone;
5. By radio; and
6. By other suitable means;
c. Immediate availability to assist the workers
in case of a failure of the air supply or for any other reason that requires
relief from distress; and
d. Sufficient numbers
and immediate availability to assist all users of this type of equipment and to
provide effective emergency rescue, if needed;
(10) Supply atmosphere‑supplying respirators
with respirable air of grade D quality or better, as defined by the Compressed
Gas Association in Publication G-7.1, “Commodity Specification for Air,” 1997,
and included in the regulations of the Occupational Safety and Health Administration
(29 CFR 1910.134(i)(1)(ii)(A) through (E)), which
contains:
a. Oxygen content (v/v) of 19.5 – 23.5%;
b. Hydrocarbon (condensed) content of 5
milligrams per cubic meter of air or less;
c. Carbon monoxide (CO) content of 10 ppm or
less;
d. Carbon dioxide content of 1,000 ppm or less;
and
e. Lack of noticeable odor; and
(11) Ensure that no objects, materials or substances, such as facial hair, or any
conditions that interfere with the face to facepiece seal or valve function,
and that are under the control of the wearer, are present between the skin of
the wearer’s face and the sealing surface of a tight-fitting respirator
facepiece.
(b) In estimating the dose to individuals from
intake of airborne radioactive materials, the concentration of radioactive
material in the air that is inhaled when respirators are worn shall be
initially assumed to be the ambient concentration in air without the
respiratory protection, divided by the APF.
(c) If the dose to individuals from intake of
airborne radioactive materials is subsequently found to be greater than the
estimated dose, the corrected value shall be used.
(d) If the dose to individuals from intake of
airborne radioactive materials is subsequently found to be less than the
estimated dose, the corrected value may be used.
(e) DHHS/RHS shall impose restrictions in
addition to the provisions of He-P 4022.07, 4022.08, and 4095, in order to:
(1) Ensure that the respiratory protection
program of the licensee or registrant is adequate to limit doses to individuals
from intakes of radioactive materials consistent with maintaining total
effective dose equivalent ALARA; and
(2) Limit the extent to which a licensee or
registrant may use respiratory protection equipment instead of process or other
engineering controls.
(f) The licensee or registrant shall seek and
obtain authorization from DHHS/RHS before using assigned protection factors in
excess of those specified in He-P 4095.
(g) DHHS/RHS shall authorize a licensee or
registrant to use higher protection factors only upon receipt and approval of
an application that:
(1) Describes the situation for which a need
exists for higher protection factors; and
(2) Demonstrates that the respiratory protection
equipment provides these higher protection factors under the proposed
conditions of use.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4022.09 Security of Stored Sources of Radiation. The licensee or registrant shall secure from
unauthorized removal or access licensed or registered sources of radiation that
are stored in controlled or unrestricted areas.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.10 Control of Sources of Radiation not in
Storage.
(a) The licensee shall control and maintain constant
surveillance of licensed material that is in a controlled or an unrestricted
area and that is not in storage.
(b) The registrant shall maintain control of
radiation machines that are in an unrestricted area and that are not in
storage.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.11 Caution Signs.
(a) Unless otherwise authorized by DHHS/RHS, the
symbol illustrated in Figure 4022.1 shall be the standard radiation symbol.
(b) The colors used for the cross-hatched area
shall be magenta, or purple, or black, and the background shall be yellow.
(c) The symbol prescribed shall be the
three-bladed design as follows:
Figure
4022.1 Radiation Symbol
(d)
Notwithstanding the requirements of He-P 4022.11, licensees or
registrants are authorized to label sources, source holders, or device
components containing sources of radiation that are subjected to high temperatures,
with conspicuously etched or stamped radiation caution symbols and without a
color requirement.
(e) In addition to the contents of signs and
labels prescribed in He-P 4022, the licensee or registrant may provide, on or
near the required signs and labels, any additional information to make
individuals aware of potential radiation exposures and to minimize the
exposures.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.12 Posting Requirements.
(a) The licensee or registrant shall post each
radiation area with a conspicuous sign or signs bearing the radiation symbol
and the words:
“CAUTION,
RADIATION AREA”.
(b) The licensee or registrant shall post each
high radiation area with a conspicuous sign or signs bearing the radiation
symbol and the words:
“CAUTION, HIGH
RADIATION AREA”
or
“DANGER, HIGH
RADIATION AREA”.
(c) The licensee or registrant shall post each
very high radiation area with a conspicuous sign or signs bearing the radiation
symbol and words:
“GRAVE DANGER,
VERY HIGH RADIATION AREA”.
(d) The licensee shall post each airborne
radioactivity area with a conspicuous sign or signs bearing the radiation
symbol and the words:
“CAUTION, AIRBORNE
RADIOACTIVITY AREA”
or
“DANGER, AIRBORNE
RADIOACTIVITY AREA”.
(e) The licensee shall post each area or room in
which there is used or stored an amount of licensed material exceeding 10 times
the quantity of such material specified in He-P 4092 with a conspicuous sign or
signs bearing the radiation symbol and the words:
“CAUTION,
RADIOACTIVE MATERIAL(S)”
or
“DANGER,
RADIOACTIVE MATERIAL(S)”.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.13 Exceptions to Posting Requirements.
(a) A licensee or registrant shall not be
required to post caution signs in areas or rooms containing sources of
radiation for periods of less than 8 hours, if each of the following conditions
is met:
(1) The sources of radiation are constantly
attended during these periods by an individual who takes the precautions
necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in He-P 4020; and
(2) The area or room is subject to the licensee’s
or registrant’s control.
(b) Rooms or other areas in hospitals that are
occupied by patients shall not be required to be posted with caution signs
pursuant to He-P 4022.12 provided that the patient could be released from
licensee control pursuant to the requirements of He-P 4035.42.
(c) Rooms or other areas in hospitals that are
occupied by patients shall not be required to be posted with caution signs,
provided that:
(1) A patient
being treated with a permanent implant could be released from confinement
pursuant to He-P 4035.25; or
(2) A patient
being treated with a therapeutic radiopharmaceutical could be released from
confinement pursuant to He-P 4035.25.
(d) A room or area is not required to be posted
with a caution sign because of the presence of a sealed source provided the
radiation level at 30 centimeters from the surface of the sealed source
container or housing does not exceed 0.05 mSv (0.005 rem) per hour.
(e) A room or area is not required to be posted
with a caution sign because of the presence of radiation machines used solely
for diagnosis in the healing arts.
(f) Rooms in hospitals or clinics that are used
for teletherapy are exempt from the requirement to post caution signs under
He-P 4022.12 if:
(1) Access to the room is controlled pursuant to
He-P 4035.51; and
(2) Personnel in attendance take necessary
precautions to prevent the inadvertent exposure of workers, other patients, and
members of the public to radiation in excess of the
limits established in this part.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8488, eff 11-18-05; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15
He-P 4022.14 Labeling Containers and Radiation Machines.
(a) The licensee shall ensure that each container
of licensed material bears a durable, clearly visible label bearing the radiation
symbol and the words:
“CAUTION,
RADIOACTIVE MATERIAL”
or
“DANGER,
RADIOACTIVE MATERIAL”.
(b) The licensee shall also provide information
to permit individuals handling or using the containers, or working in the
vicinity of the containers, to take precautions to avoid or minimize exposures,
such as:
(1) The radionuclides present;
(2) An estimate of the quantity of radioactivity;
(3) The date for which the activity is estimated;
(4) Radiation levels;
(5) Kinds of materials; and
(6) Mass enrichment.
(c) Each licensee shall, prior to removal or
disposal of empty uncontaminated containers to unrestricted areas, remove or
deface the radioactive material label or otherwise clearly indicate that the
container no longer contains radioactive materials.
(d) Each registrant shall ensure that each
radiation machine is labeled in a conspicuous manner which cautions individuals
that radiation is produced when it is energized.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.15 Exemptions to Labeling Requirements.
(a) A licensee shall not be required to label:
(1) Containers holding licensed
material in quantities less than the quantities listed in He-P 4092;
(2) Containers holding licensed material in
concentrations less than those specified in Table 4090.1, Table III of He-P
4090;
(3) Containers attended by an individual who
takes the precautions necessary to prevent the exposure of individuals in excess of the limits established by He-P 4020;
(4) Containers when they are in transport and
packaged and labeled in accordance with the regulations of the U.S. Department
of Transportation;
(5) Containers that are accessible only to
individuals authorized to handle or use them, or to work in the vicinity of the
containers, if the contents are identified to these individuals by a readily
available written record; or
(6) Installed manufacturing or process equipment,
such as piping and tanks.
(b) The record specified in He-P 4022.15(a)(5)
shall be retained as long as the containers are in use
for the purpose indicated on the record.
Source. #5903, eff 2-1-95;
ss by #6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss
by #8808, eff 1-24-07; ss by #10805, eff 3-28-15
He-P 4022.16 Procedures for Receiving and Opening
Packages.
(a) Each licensee who expects to receive a
package containing quantities of radioactive material in
excess of a Type A quantity, as defined in 10 CFR 71.4 and Appendix A to
10 CFR 71, shall make arrangements to receive:
(1) The package when the carrier offers it for
delivery; or
(2) The notification of the arrival of the
package at the carrier’s terminal and to take possession of the package
expeditiously.
(b) Each licensee shall:
(1) Monitor the external surfaces of a package
labeled with a Radioactive White I, Yellow II, or Yellow III label as specified
in U.S. Department of Transportation regulations 49 CFR 172.403 and 172.436-440
for radioactive contamination unless the package contains only radioactive
material in the form of gas or in special form as defined in
He-P 4003;
(2) Monitor the external surfaces of a package
labeled with a Radioactive White I, Yellow II, or Yellow III label as specified
in U. S. Department of Transportation regulations 49 CFR 172.403 and
172.436-440 for radiation levels unless the package contains quantities of
radioactive material that are less than or equal to the Type A quantity, as
defined in 10 CFR 71.4 and appendix A to 10 CFR 71; and
(3) Monitor all packages known to contain
radioactive material for radioactive contamination and radiation levels if
there is evidence of degradation of package integrity, such as packages that
are crushed, wet, or damaged.
(c) The licensee shall perform the monitoring
required by He-P 4022.16(b) as soon as practicable after receipt of the
package, but not later than 3 hours after the package is received at the
licensee's facility if it is received during the licensee's normal working
hours, or not later than 3 hours from the beginning of the next working day if
it is received after working hours.
(d) The licensee shall immediately notify the
final delivery carrier and DHHS/RHS when:
(1) Removable radioactive surface contamination
exceeds the limits of He-P 4037.04(a); or
(2) External radiation levels exceed the limits
of He-P 4037.04(a).
(e) Notification required by He-P 4022.16(d)
shall occur by telephone, mail, or facsimile.
(f) Each licensee shall:
(1) Establish, maintain, and retain written
procedures for safely opening packages in which radioactive material is
received; and
(2) Ensure that the procedures are followed and that due consideration is given to special
instructions for the type of package being opened.
(g) Licensees transferring special form sources
in vehicles owned or operated by the licensee to and from a work site are
exempt from the contamination monitoring requirements of He-P 4022.16(b), but
shall not be exempt from the monitoring requirement in He-P 4022.16(b) for
measuring radiation levels that ensures that the source is still properly
lodged in its shield.
Source. #6827, eff 8-6-98;
ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07;
ss by #10805, eff 3-28-15