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.

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, 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 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) 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 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 4003.05(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; 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; ss by #13599, eff 3-24-23

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 × 10^6	980 × 10^8
1 × 10^-7	2	980 × 10^6	980 × 10^8
1 × 10^-6	2	810 × 10^6	810 × 10^8
1 × 10^-5	2	810 × 10^6	810 × 10^8
1 × 10^-4	2	840 × 10^6	840 × 10^8
1 × 10^-3	2	980 × 10^6	980 × 10^8
1 × 10^-2	2.5	1010 × 10^6	1010 × 10^8
1 × 10^-1	7.5	170 × 10^6	170 × 10^8
5 × 10^-1	11	39 × 10^6	39 × 10^8
1	11	27 × 10^6	27 × 10^8
2.5	9	29 × 10^6	29 × 10^8
5	8	23 × 10^6	23 × 10^8
7	7	24 × 10^6	24 × 10^8
10	6.5	24 × 10^6	24 × 10^8
14	7.5	17 × 10^6	17 × 10^8
20	8	16 × 10^6	16 × 10^8
40	7	14 × 10^6	14 × 10^8
60	5.5	16 × 10^6	16 × 10^8
100	4	20 × 10^6	20 × 10^8
200	3.5	19 × 10^6	19 × 10^8
300	3.5	16 × 10^6	16 × 10^8
400	3.5	14 × 10^6	14 × 10^8

(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 or by the Nuclear Regulatory Commission (NRC) in 10 CFR 71.4.

(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 or by the NRC in 10 CFR 71.4.

(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 (1 MeV).  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 (NH) 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 United States (U.S.) NRC or the U.S. Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954 (the Act), as amended (68 Stat. 919).

(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-economic 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. The term APF includes the ratio of ambient airborne concentration divided by inhaled concentration.

(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 department of health and human services radiological health section (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)  “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 U.S. NRC, 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.

(v)  “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.

(w)  “Chelating agent” means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.

(x)  “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.”

(y)  “Class D” means a class having a range of clearance half-times of less than 10 days.

(z)  “Class W” means a class having a range of clearance half-times of 10 to 100 days.

(aa)  “Class Y” means a class having a range of clearance half-times of greater than 100 days.

(ab)  “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.

(ac)  “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.

(ad)  “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.

(ae)  “Commissioner” means the commissioner of department of health and human services (DHHS), or the commissioner’s designee.

(af)  “Committed dose equivalent (H_T,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.

(ag)  “Committed effective dose equivalent (H_E,50)” is the sum of the products of the weighting factors (w_T) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent (H_T,₅₀) to each of these organs or tissues (H_E,50 = Σw_T H_T,50).

(ah)  “Condition of light work” means an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year.

(ai) “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 should be located at an educational institution or a Federal facility or a medical facility.

(aj)  “Constraint” means a value above which specified license actions are required.  This term includes “dose constraint.”

(ak)  “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.

(al)  “Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

(am)  “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).

(an)  “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.

(ao)  “Declared pregnant woman” means a woman who has voluntarily informed the licensee, 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.

(ap)  “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.

(aq) “Decommissioning plan” means a written document that includes the licensee’s planned procedures and activities for decommissioning of the facility or site.

(ar)  “Deep dose equivalent (H_d),” applicable to external whole-body exposure, means the dose equivalent at a tissue depth of one centimeter (1000 mg/cm²).

(as)  “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.

(at)  “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.

(au)  “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.

(av)  “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.

(aw)  “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.

(ax)  “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. The term includes the type of respirator that is a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

(ay)  “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.

(az)  “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.”

(ba)  “Dose equivalent (H_T)” 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.

(bb)  “Dose limits” means the permissible upper bounds of radiation doses established in accordance with these rules.

(bc)  “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.

(bd)  “Effective dose equivalent (H_E)” means the sum of the products of the dose equivalent to each organ or tissue (H_T) and the weighting factor (w_T) applicable to each of the body organs or tissues that are irradiated.

(be)  “Embryo” means the developing human organism from conception until the time of birth. The term includes “fetus”.

(bf)  “Entrance or access point” means any opening through which 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.

(bg)  “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.

(bh)  “Exposure” means being exposed to ionizing radiation or to radioactive material.

(bi)  “Exposure rate” means the exposure per unit of time.

(bj)  “External dose” means that portion of the dose equivalent received from any source of radiation outside the body.

(bk)  “Extremity” means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

(bl)  “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.

(bm)  “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.”

(bn)  “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.

(bo)  “Fit test” means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

(bp)  “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 DHHS/RHS’s release criteria.

(bq)  “Former U.S. Atomic Energy Commission (AEC) or U.S. 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.

(br)  “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.

(bs)  “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 rads.

(bt)  “Hazardous waste” means those wastes designated as hazardous by U.S. Environmental Protection Agency regulations in 40 CFR 261.

(bu)  “Healing arts” means the diagnosis and treatment of ailments for humans.

(bv)  “Helmet” means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

(bw)  “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.

(bx)  “Hood” means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

(by)  “Human use” means the internal or external administration of radiation or radioactive material to human beings.

(bz)  “Individual” means any human being.

(ca)  “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.

(cb)  “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 “personal electronic dose monitoring equipment.”

(cc)  “Inspection” means an official examination or observation to determine compliance with rules and orders of DHHS/RHS.

(cd)  “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.

(ce)  “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.

(cf)  “Internal dose” means that portion of the dose equivalent received from radioactive material taken into the body.

          (cg)  “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.

(ch)  “Lens dose equivalent (LDE)” means the external exposure to the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm²).

(ci)  “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.”

(cj) “Licensed material” means source material, special nuclear material, or byproduct material received, possessed, used, transferred, or disposed of under a license issued by DHHS/RHS.

(ck)  “Licensee” means:

(1)  Any person who is licensed by DHHS/RHS in accordance with the Act and He-P 4000; or

(2) Any person who is responsible for decommissioning by being registered with 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.

(cl)  “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.

(cm)  “Limits” means the permissible upper bounds of radiation doses. 

(cn)  “Loose-fitting facepiece” means a respiratory inlet covering that is designed to form a partial seal with the face.

(co)  “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.

(cp)  “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.

(cq)  “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.

(cr)  “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.

(cs)  “Minor” means an individual less than 18 years of age.

(ct)  “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.

(cu)  “Naturally occurring and accelerator-produced radioactive material (NARM)” means any naturally occurring or accelerator-produced radioactive material other than byproduct, source, or special nuclear material.

(cv)  “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.

(cw)  “Natural radioactivity” means radioactivity of naturally occurring nuclides.

(cx)  “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.”

(cy)  “Nonstochastic effect” means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. The term includes “deterministic effect”.

(cz)  “Naturally occurring radioactive material (NORM)” means any naturally occurring radioactive material found in the environment and contains radioactive elements of natural origin.

(da)  “Nuclear facility” means a U.S. Department of Energy (DOE) reactor or nonreactor nuclear facility where an activity is conducted for, or on behalf of, DOE, including any related area, structure, facility, or activity to the extent necessary to ensure proper implementation of the requirements established in 10 CFR Part 830.

(db)  “Nuclear Regulatory Commission (NRC)” means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

(dc)  “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.

(dd)  “Package” means packaging plus its radioactive contents as presented for transport.

(de)  “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.  The term includes “accelerator”.

(df)  “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”.

(dg)  “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.”

(dh)  “Physician” means an individual licensed in this state to practice medicine.

(di)  “Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

(dj)  “Positive pressure respirator” means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

(dk)  “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.

(dl)  “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.

(dm)  “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.

(dn)  “Protective apron” means an apron made of radiation‑attenuating materials used to reduce exposure to radiation.

(do)  “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.

(dp)  “Pyrophoric liquid” means any liquid that ignites spontaneously in dry or moist air at or below 130° F (54.4° C).

(dq)  “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.

(dr)  “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.

(ds)  “Qualitative fit test (QLFT)” means a pass or fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.

(dt)  “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.

(du)  “Quantitative fit test (QNFT)” means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

(dv)  “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.”

(dw)  “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.

(dx)  “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.”

(dy)  “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.

(dz)  “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”.

(ea)  “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

(3) Is identified as a radiation safety officer on an Agency license, an NRC license, or Agreement State license or other equivalent permit or license recognized by the Agency for similar types and uses of byproduct material.

(eb)  “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.

(ec)  “Radioactivity” means the transformation of unstable atomic nuclei by the emission of radiation.

(ed)  “Radiological health section (RHS)” means the radiological health section of the division of public health services in DHHS.

(ee) “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.

(ef)  “Registrant” means any person who is registered with DHHS/RHS and is legally obligated to register with DHHS/RHS pursuant to these rules and the Act.

(eg)  “Registration” means “registration” as defined in RSA 125-F:3, XVIII, namely, “registration in accordance with rules adopted pursuant to this chapter.”

(eh)  “Regulations of the U.S. Department of Transportation” means the regulations in 49 CFR 100-177.

(ei)  “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.

(ej)  “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 byproduct material to human beings.

(ek)  “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.

(el)  “Respiratory protective device” means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

(em)  “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.

(en)  “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, or holder of the record of possession.

(eo)  “Roentgen” means the special unit of exposure where one roentgen (R) equals 2.58E-4 coulombs per kilogram of air.

(ep)  “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.

(eq)  “Sealed source” means any byproduct material that is encased in a capsule designated to prevent leakage or escape of the byproduct material.

(er)  “Sealed source and device registry (SSD)” means the national registry that contains the registration certificates, maintained by the NRC, that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.

(es)  “Self-contained breathing apparatus (SCBA)” means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

(et)  “Shallow dose equivalent (H_s)” 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.

(eu)  “Short-lived radon daughters of radon-222” means polonium-218, lead-214, bismuth-214, and polonium-214.

(ev)  “Short-lived radon daughters of radon-220” means polonium-216, lead-212, bismuth-212, and polonium-212.

(ew)  “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.

(ex)  “Site” means the area contained within the boundary of a location under the control of licensee or registrant generating or storing source of radiation.

(ey)  “Site boundary” means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(ez)  “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.”

(fa)  “Source material milling” means any activity that results in the production of radioactive material as defined in He-P 4003.01(eb).

(fb)  “Source of radiation” means “source of radiation” as defined in RSA 125-F:3, XX, namely, “collectively, radioactive material and radiation equipment.”

(fc)  “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.

(fd)  “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. NRC 10 CFR 71.

(fe)  “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.”

(ff)  “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.

(fg)  “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.

(fh)  “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.

(fi)  “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.”

(fj)  “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.

(fk)  “Test” means the process of verifying compliance with an applicable rule.

(fl)  “Tight-fitting facepiece” means a respiratory inlet covering that forms a complete seal with the face.

(fm)  “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.

(fn)  “Total organ dose equivalent (TODE)” means the sum of the deep dose equivalent, as defined in He-P 4003.01(as), and the committed dose equivalent, as defined in He-P 4003.01(ag), and recorded for the maximally exposed organ.

(fo)  “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.

(fp)  “U.S. Department of Energy” means the Department of Energy that manages the United States' nuclear infrastructure and administers the country's energy policy.

(fq)  “Unrefined and unprocessed ore” means ore in its natural form prior to any processing.

(fr)  “Unrestricted area” means an area access to which is neither limited nor controlled by the licensee or registrant.

(fs)  “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.

(ft)  “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.

(fu)  “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.

(fv) “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.

(fw)  “Waste handling licensees” means persons licensed to receive and store radioactive wastes prior to disposal and persons licensed to dispose of radioactive waste.

(fx)  “Week” means 7 consecutive days starting on Sunday.

(fy)  “Weighting factor (w_T) 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.

(fz)  “Whole body” means external exposure of head, trunk including male gonads, arms above the elbow, or legs above the knee.

(ga)  “Worker” means an individual engaged in activities under a license or registration issued by DHHS/RHS and controlled by a licensee or registrant, but does not include the licensee or registrant.

(gb)  “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.

(gc)  “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.

(gd)  “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; ss by #13371, eff 4-20-22; ss by #14012, eff 6-28-24

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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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 He-P 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 He-P 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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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 radioactive materials or 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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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) through (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 their 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 or to radioactive material:

(1)  As shown in records maintained by the licensee or registrant pursuant 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 radioactive materials or 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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

He-P 4019.07  Consultation with Workers During Inspections.

(a)  DHHS/RHS inspectors may consult privately with workers, either on their own volition or at the request of any of the 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 may bring privately to the attention of the inspectors, either orally or in writing, any past or present condition which the 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 radioactive material or 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(b).

(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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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:

(1)  Because such worker has filed any complaint or instituted or caused to be instituted any proceeding under these rules;

(2)  Because such worker has testified or is about to testify in any such proceeding; or

(3)  Because of the exercise by such worker on behalf of themself or others of any option afforded by He-P 4019.

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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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(d) 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(d).

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; ss by #14301, eff 7-1-25, EXPIRES: 7-1-35

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 department of health and human services radiological health section (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 should 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; ss by #14028, eff 7-23-24

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 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; ss by #14028, eff 7-23-24

He-P 4020.03 Implementation. 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.

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; ss by #14028, eff 7-23-24

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 (CFR), 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; ss by #14028, eff 7-23-24

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 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.

(h) Derived air concentration (DAC) and annual limit on intake (ALI) values shall be as stated in He-P 4090 or in 10 CFR 20 Appendix B 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; ss by #13371, eff 4-20-23; ss by #14028, eff 7-23-24

He-P 4020.06 Compliance with Requirements for Summation of External and Internal Doses.

(a)  If the licensee or registrant shall 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 shall monitor only pursuant to He-P 4022.02(b) or only pursuant to He-P 4022.02(c), then summation shall not be 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 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 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, W_T, and the committed dose equivalent, H_T,50, per unit intake is greater than 10 percent of the maximum weighted value of H₅₀, that is, W_TH_T,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; ss by #14028, eff 7-23-24

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; ss by #14028, eff 7-23-24

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 DHHS/RHS for review;

b.  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.  DHHS/RHS has granted its approval; or

(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 or in 10 CFR 20 Appendix B.

(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 He-P 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 or in 10 CFR 20 Appendix B 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 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; ss by #13371, eff 4-20-22; ss by #14028, eff 7-23-24

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 thermoluminescent dosimeter 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 to the whole body;

2.  The lens-dose equivalent recorded for the lens of the eye;

3.  The shallow-dose equivalent recorded for the skin of the whole body;

4.  The shallow-dose equivalent recorded for the skin of the extremity receiving the maximum dose;

5.  The committed effective dose equivalent recorded for the maximally exposed organ;

6.  The total effective dose equivalent; and

7.  The total organ dose equivalent 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 the individual’s 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 be required to evaluate separate external dose equivalents and internal committed dose equivalents on the intake of radionuclides by the occupational worker.

(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; ss by #14028, eff 7-23-24

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)  The 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; ss by #14028, eff 7-23-24

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; ss by #14028, eff 7-23-24

He-P 4020.12 Dose to an Embryo or Fetus.

(a)  The licensee or registrant shall ensure that the dose equivalent to an embryo or 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 or 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 or fetus resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman.

(d)  If the dose equivalent to the embryo or 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 or 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; ss by #14028, eff 7-23-24

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, 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:

(1)  Demonstration of the need for and the expected duration of operations in excess of the limit in He-P 4020.13(a);

(2)  The licensee’s or registrant’s program to assess and control dose within the 5 mSv (0.5 rem) annual limit; and

(3)  The procedures to be followed to maintain the dose ALARA.

(f)  As authorized by, and in accordance with He-P 4030.07, He-P 4030.09, and He-P 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; ss by #14028, eff 7-23-24

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, as appropriate, 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:

(1) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or

(2) Demonstrating that:

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; or the equivalent tables in 10 CFR 20 Appendix B; 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 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 or the equivalent tables in 10 CFR 20 Appendix B for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as:

(1) Aerosol size distribution;

(2) Solubility;

(3) Density;

(4) Radioactive decay equilibrium; and

(5) Chemical form.

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; ss by #13371, eff 4-20-22; ss by #14028, eff 7-23-24

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 international system of units (SI) 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 He-P 4024.

(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 He-P 4024, such as:

(1)  Total effective dose equivalent;

(2)  Shallow-dose equivalent;

(3)  Lens dose equivalent;

(4)  Deep-dose equivalent; or

(5)  Committed effective dose equivalent.

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; ss by #14091, eff 10-1-24

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:

(1)  The provisions of the program; and

(2)  Audits and other reviews of program content and implementation.

(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; ss by #14091, eff 10-1-24

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:

(1)  Records of the results of surveys to determine the dose from external sources of radiation used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents;

(2)  Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used in the assessment of internal dose;

(3)  Records showing the results of air sampling, surveys, and bioassays required pursuant to He-P 4022.08(a)(4)a. and (a)(4)b.; and

(4)  Records of the results of measurements and calculations used to evaluate the release of radioactive effluents to the environment.

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; ss by #14091, eff 10-1-24

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 department of health and human services radiological health section (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; ss by #14091, eff 10-1-24

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 DHHS/RHS for transfer to 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; ss by #14091, eff 10-1-24

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:

(1)  The exceptional circumstances requiring the use of a planned special exposure;

(2)  The name of the management official who authorized the planned special exposure and a copy of the signed authorization;

(3)  What actions were necessary;

(4)  Why the actions were necessary;

(5)  What precautions were taken to assure that doses were maintained as low as reasonably achievable (ALARA);

(6)  What individual and collective doses were expected to result; and

(7)  The doses actually received in the planned special exposure.

(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; ss by #14091, eff 10-1-24

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:

(1)  The deep-dose equivalent to the whole body, lens dose equivalent, shallow-dose equivalent to the skin, and shallow-dose equivalent to the extremities;

(2)  The estimated intake of radionuclides;

(3)  The committed effective dose equivalent assigned to the intake of radionuclides;

(4)  The specific information used to calculate the committed effective dose equivalent pursuant to He-P 4020.08(a) and (c), and when required by He-P 4022.02;

(5)  The total effective dose equivalent when required by He-P 4020.06; and

(6)  The total of the deep-dose equivalent and the committed dose to the organ receiving the highest total dose.

(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:

(1)  The full name of the individual monitored for occupational radiation dose;

(2)  The monitored individual’s identification number and identification type;

(3)  The sex of the monitored individual;

(4)  The date of birth of the monitored individual in the format MM/DD/YYYY;

(5)  The monitoring period for the which the report is filed, in the format MM/DD/YYYY – MM/DD/YYYY;

(6)  The name of the licensee or registrant;

(7)  The license or registration number or numbers;

(8)  For the monitoring period reported, an indication as to whether the dose data listed represents:

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 thermoluminescent dosimeter (TLD) or optically stimulated luminescence (OSL) 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;

(9)  The symbol for each radionuclide that resulted in an internal exposure recorded for the individual;

(10)  The lung clearance class for all intakes by inhalation;

(11)  The mode of intake, including inhalation, absorption through the skin, oral ingestion, or injection;

(12)  The intake quantity of each radionuclide in curies;

(13)  For the monitoring period, the following dose data:

a.  The deep-dose equivalent to the whole body;

b.  The lens dose equivalent 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) or the committed dose equivalent to the maximally exposed organ (CDE), or “NR” for “Not Required” or “NC” for “Not Calculated”;

f.  The total effective dose equivalent; and

g.  The total organ dose equivalent for the maximally exposed organ;

(14)  Additional comments, as necessary, to demonstrate compliance with the dose limits. An example may be to enter the note that the SDE, ME was the result of exposure from a discrete hot particle.  Another possibility shall be to indicate that an overexposed report has been sent to DHHS/RHS in reference to the exposure report; and

(15)  The date and signature of the person designated to represent the licensee or registrant.

(f)  The licensee or registrant shall maintain the records of dose to an embryo or 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 the personal privacy nature of the 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; ss by #14091, eff 10-1-24

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 required by He-P 4020.13.

(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; ss by #14091, eff 10-1-24

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:

(1)  Type of radioactive material;

(2)  Activity at time of disposal;

(3)  Date of disposal; and

(4)  Method of disposal.

(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; ss by #14091, eff 10-1-24

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; ss by #14091, eff 10-1-24

He-P 4021.11  Form of Records.

(a)  Each record required by He-P 4020 – He-P 4024 shall be legible throughout the specified retention period.

(b)  The record shall be the original, a reproduced copy, or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform can produce 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; ss by #14091, eff 10-1-24

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 DHHS/RHS by telephone.

(b)  Reports shall be made as follows:

(1)  Immediately if an aggregate quantity is equal to or greater than 1,000 times the quantity specified in He-P 4092, or if under such circumstances it appears to the licensee or registrant that a radiation machine is missing or that an exposure could result from sources of radiation to individuals in unrestricted areas; or

(2)  Within 30 days if an aggregate quantity is greater than 10 times the quantity specified in He-P 4092, or if a radiation machine is still missing.

(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 DHHS/RHS.

(d)  Reports shall contain:

(1)  A description of the licensed or registered source of radiation involved, including:

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;

(2)  A description of the circumstances under which the loss or theft occurred;

(3)  A statement of disposition, or probable disposition, of the licensed or registered source of radiation involved;

(4)  Exposures of individuals to radiation, circumstances under which the exposures occurred, and the possible total effective dose equivalent to persons in unrestricted areas;

(5)  Actions that have been taken, or will be taken, to recover the source of radiation; and

(6)  Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed or registered sources of radiation.

(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 DHHS/RHS pursuant to He-P 4021.12 so that names of individuals who might 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; ss by #14091, eff 10-1-24

He-P 4021.13  Notification of Incidents.

(a)  Notwithstanding other requirements for notification, each licensee or registrant shall immediately report to DHHS/RHS by telephone each event involving a source of radiation possessed by the licensee or registrant that might have caused or threatens to cause any of the following:

(1)  An individual to receive:

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

(2)  The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake 5 times the occupational annual limit on intake (ALI).

(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 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 might have caused, or threatens to cause, any of the following:

(1)  An individual to receive, in a period of 24 hours:

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

(2)  The release of radioactive material, inside or outside of a restricted area, so that, had an individual been present for 24 hours, the individual could have received an intake in excess of one occupational ALI.

(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 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)  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; ss by #14091, eff 10-1-24

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:

(1)  Incidents for which notification is required by He-P 4021.13;

(2)  Doses in excess of any of the following:

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 or 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) and (e);

(3)  Levels of radiation or concentrations of radioactive material in:

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

(4)  For licensees subject to the provisions of the United States Environmental Protection Agency’s generally applicable environmental radiation standards in 40 CFR 190, levels of radiation or releases of radioactive material in excess of those standards, or of license conditions related to those standards.

(b)   Each report required by (a) above shall describe the extent of exposure of individuals to radiation and radioactive material, including:

(1)  Estimates of each individual’s dose or of the declared pregnant woman’s dose with respect to the limit for the embryo or fetus in He-P 4020.12;

(2)  The levels of radiation and concentrations of radioactive material involved;

(3)  The cause of the elevated exposures, dose rates, or concentrations; and

(4)  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.

(c)  Each report filed pursuant to (a) above shall be protected from public disclosure under the authority of RSA 91-A:5 and the Privacy Act of 1974, Public Law 93-579, 52 U.S.C. 552a, and shall include for each individual exposed:

(1)  The name;

(2)  Social security number, as authorized by 10 CFR 20.2203(b)(2); and

(3)  Date of birth.

(d)  Reports in (a), (b), and (c) above shall be prepared so that this information is stated in a separate and detachable portion of the report.

(e)  Reports in (a), (b), and (c) above shall be clearly labeled “Confidential Information: Not for Public Disclosure” and shall be protected from public disclosure under the authority of RSA 91-A:5 and the Privacy Act of 1974, Public Law 93-579, 52 U.S.C. 552a.

(f)  All licensees or registrants who make reports pursuant to (a) above shall submit the report in writing to 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; ss by #14091, eff 10-1-24

He-P 4021.15  Reports of Planned Special Exposures.  The licensee or registrant shall submit a written report to DHHS/RHS within 30 days following any planned special exposure conducted in accordance with He-P 4020.10, informing 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; ss by #14091, eff 10-1-24

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 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 DHHS/RHS to the individual, and such report shall be transmitted at a time no later than the transmittal to 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; ss by #14091, eff 10-1-24

He-P 4021.17  Reports of Individual Monitoring.

(a)  This section applies to each person licensed or registered by DHHS/RHS to:

(1)  Possess or use sources of radiation for purposes of industrial radiography pursuant to He-P 4030 and He-P 4034; or

(2)  Possess or use at any time, for processing or manufacturing for distribution pursuant to He-P 4030, He-P 4032, He-P 4033, or He-P 4035, radioactive material in quantities exceeding any one of the quantities indicated in Table 4021.1:

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, or used radionuclides not on this list in quantities sufficient to cause comparable radiation levels, 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 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; ss by #14091, eff 10-1-24

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 DHHS/RHS any exposure of an individual to radiation or radioactive material, the licensee or registrant shall also notify the individual.

(c)  Such notice as stated in (b) above shall be transmitted at a time not later than the transmittal to 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; ss by #14091, eff 10-1-24

He-P 4021.19  Reports of Leaking or Contaminated Sealed Sources.

(a)  The licensee or registrant shall file a report within 5 days with 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; ss by #14091, eff 10-1-24

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 might have been contaminated with radioactive material as a result of licensee’s activities, notify 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 below 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 might 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 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; ss by #14091, eff 10-1-24

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:

Table 4021.2  Permissible Levels of Surface Contamination

	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; ss by #14091, eff 10-1-24

He-P 4021.22 Reports of Transactions Involving Nationally Tracked Sources.

(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 by using 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 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 by using 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 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, or in 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 by using 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 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, or in 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 by using 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 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 postal mail to the address found on the NRC form entitled “NRC Form 748”; or

e. 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; ss by #14091, eff 10-1-24

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 decommissioning, 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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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 or the equivalent tables in 10 CFR 20 Appendix B;

(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; ss by #13371, eff 4-20-22; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

He-P 4022.03  Location of Individual Monitoring Devices.

(a)  Each licensee or registrant shall ensure that individuals who are required to be monitored for 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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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 the department of health and human services radiological health section (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 as low as is reasonably achievable (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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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 additional 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 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 4043 for industrial radiography; and

(2)  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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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 irradiators.

(b)  This section shall not apply to sources of radiation that are used:

(1)  In medical radiology or 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 at 30 centimeters from the source; 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 source(s) return to their fully shielded position; and

b.  Conspicuous visible and audible alarm signals shall be activated to make:

1.  An individual attempting to enter the area aware of the hazard; and

2.  At least one other individual, who is physically present and trained on how to respond to the alarm and prepared to render or summon assistance;

(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 10 mSv (1 rem) in any one hour at 30 centimeters from the source or from any surface that the radiation penetrates; and

b.  Conspicuous visible and audible alarm signals shall be activated 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 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 leave the room before the source leaves the shielded position;

(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 provided with a radiation monitor to prevent room access when the radiation levels from the source of radiation in the area are high such that 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 4022.06(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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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 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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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)  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;

(6)  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;

(7)  Use safety, radiological protection or other equipment in such a way as not to interfere with the proper operation of the respirator;

(8)  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;

(9)  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

(10)  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, He-P 4022.08, and He-P 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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

He-P 4022.15 Exemptions to Labeling Requirements. A licensee shall not be required to label:

(a)  Containers holding licensed material in quantities less than the quantities listed in He-P 4092;

(b) Containers holding licensed material in concentrations less than those specified in He-P 4090, Table 4090.1, Table III;

(c) Containers attended by an individual who takes the precautions necessary to prevent the exposure of individual in excess of the limits established by He-P 4020;

(d) Containers when they are in transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation;

(e) 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 to be retained as long as the containers are in use for the purpose indicated on the record; or

(f) Installed manufacturing or process equipment, such as piping and tanks.

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; ss by #13371, eff 4-20-22; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35

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.

(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; ss by #14303, eff 7-1-25, EXPIRES: 7-1-35