TITLE 20 ENVIRONMENTAL PROTECTION
CHAPTER 3 RADIATION PROTECTION
PART 1 GENERAL PROVISIONS
20.3.1.1 ISSUING AGENCY: Environmental Improvement Board.
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20.3.1.2 SCOPE: Except as otherwise specifically provided, this part applies to all persons who receive, possess, use, transfer, own or acquire any source of radiation; provided, however, that nothing in this part shall apply to any person to the extent that such person is subject to regulations by the NRC. Regulation by the state 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 state and the NRC and 10 CFR Part 150.
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20.3.1.3 STATUTORY AUTHORITY: Sections 74-1-9, 74-3-5 and 74-3-9 NMSA 1978.
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20.3.1.4 DURATION: Permanent.
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20.3.1.5 EFFECTIVE DATE: April 30, 2009, unless a later date is cited at the end of a section.
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20.3.1.6 OBJECTIVES:
A. To protect the public and occupationally exposed individuals from unnecessary exposure to ionizing radiation.
B. To provide for the safe possession and use of radioactive materials and radiation machines in keeping with the ALARA principle, as defined in 20.3.4.7 NMAC.
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20.3.1.7 DEFINITIONS: As used in these regulations, these terms have the definitions as set forth below.
A. “Accelerator” (See particle accelerator).
B. “Accelerator produced material” means any material made radioactive by exposure to radiation from a particle accelerator.
C. “Act” means the Radiation Protection Act (Sections 74-3-1 through 74-3-16, NMSA 1978).
D. “Agreement state” means any state with which the United States nuclear regulatory commission (NRC) or the United States atomic energy commission (AEC) has entered into an effective agreement under Section 274b of the Atomic Energy Act, as amended (73 Stat. 689).
E. “Board” means the environmental improvement board.
F. “Byproduct material” means:
(1) 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 any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes; underground ore bodies depleted by these solution extraction operations do not constitute byproduct material within this definition;
(3) any discrete source of radium-226 that is produced, extracted or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical or research activity;
(4) any material that:
(a) has been made radioactive by use of a particle accelerator; and
(b) is produced, extracted or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical or research activity; or
(5) any discrete source of naturally occurring radioactive material, other than source material, that
(a) NRC, in consultation with the administrator of the environmental protection agency (EPA), 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) before, on, or after August 8, 2005, is extracted or converted after extraction for use in a commercial, medical or research activity.
G. “Calibration” means the quantitative evaluation and adjustment, as deemed necessary by the department, of radiation measuring instruments by a department approved laboratory. Calibration includes 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 using national institute of standards and technology (NIST) traceable sources and approved techniques.
H. “CFR” means code of federal regulations.
I. “Chelating agent” means amine polycarboxylic acids, hydroxycarboxylic acids, gluconic acid and polycarboxylic acids.
J. “Commercial waste disposal” means disposal of radioactive waste as a business enterprise.
K. “Consortium” means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a federal facility or a medical facility.
L. “Council” means the radiation technical advisory council (RTAC).
M. “Curie” means that amount of radioactive material which disintegrates at the rate of 37 billion atoms per second.
N. “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.
O. “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.
P. “Department” means the environment department, its successors, or its predecessors, the environmental improvement agency, or the environmental protection division of the environment department.
Q. “Depleted uranium” means the source material uranium which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.
R. “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.
S. “DOE” means the United States department of energy established by the Department of Energy Organization Act (Public Law 95-91, 91 Stat. 565, 42 U.S.C. 7101 et. seq.) to the extent that the DOE, or its duly authorized representatives, exercises functions formerly vested in the United States atomic energy commission (AEC), its chairman, members, officers and components and transferred to the United States energy research and development administration (ERDA) and to the administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act (Public Law 93-438, 88 Stat. 1233 at 1237, 42 U.S.C. 5814) and retransferred to the secretary of energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, 91 Stat. 565 at 577-578, 42 U.S.C. 7151).
T. “DOT” means the United States department of transportation.
U. “EPA” means the United States environmental protection agency.
V. “FDA” means the United States food and drug administration.
W. “Former U.S. atomic energy commission (AEC) or 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.
X. “Government agency” means any state or federal executive department, commission, independent establishment, corporation, wholly or partly owned by any state or the United States of America which is an instrumentality of the state or United States, or any board, bureau, division, service, office, officer, authority, administration or other establishment in the executive branch of the government.
Y. “Hazardous waste” means those wastes designated as hazardous by EPA regulations in 40 CFR Part 261.
Z. “Healing arts” means those professional disciplines authorized by the laws of this state to use x-rays or radioactive material in the diagnosis or treatment of human or animal disease.
AA. “Human use” means the internal or external administration of radiation or radioactive material to human beings for the purpose of medical diagnosis or therapy.
BB. “Individual” means any human being.
CC. “Inspection” means an official examination or observation including, but not limited to, tests, surveys and monitoring to determine compliance with rules, regulations, orders, requirements and license or registration conditions of the department.
DD. “License” means a license issued by the department in accordance with 20.3 NMAC.
EE. “Licensed material” means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the department.
FF. “Licensee” means the holder of a license.
GG. “Licensing state” means any state with regulations equivalent to the suggested state regulations for control of radiation (SSRCR) relating to, and an effective program for, the regulatory control of NARM (as defined in 20.3.1.7 NMAC) and which has been granted final designation by the conference of radiation control program directors, incorporated (CRCPD).
HH. “Lost or missing licensed material” means licensed material whose location is unknown. This definition includes, but is not limited to, material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
II. “Major processor” means a user processing, handling or manufacturing radioactive material exceeding type A quantities as unsealed sources or material, or exceeding four times type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers or small industrial programs. Type A and B quantities are defined in 10 CFR Part 71.4.
JJ. “Mixed waste” contains both hazardous waste (as defined by Resource Conservation and Recovery Act (RCRA) and its amendments) and radioactive waste (as defined by Atomic Energy Act (AEA) and its amendments). It is jointly regulated by NRC or NRC's agreement states and EPA or EPA's RCRA authorized states. The fundamental and most comprehensive statutory definition is found in the Federal Facilities Compliance Act (FFCA) where Section 1004(41) was added to RCRA: “The term 'mixed waste' means waste that contains both hazardous waste and source, special nuclear, or byproduct material subject to the Atomic Energy Act.”
KK. “NARM” means any naturally occurring or accelerator-produced radioactive material. It does not include source or special nuclear material.
LL. “Natural radioactivity” means radioactivity of naturally occurring nuclides.
MM. “NRC” means the United States nuclear regulatory commission or its duly authorized representatives.
NN. “Ore refineries” means all processors of a radioactive material ore including uranium mills or other source material extraction facilities.
OO. “Particle accelerator” (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 1 megaelectron volt. For purposes of this definition, “accelerator” is an equivalent term. Particle accelerators which intentionally produce radioactive materials or produce radioactive materials incidental to the operation of an accelerator shall be subject to the licensing requirements in 20.3.3 NMAC. Particle accelerators which produce radiation for research, diagnostic or therapeutic purposes shall be subject to the registration requirements in 20.3.2 and 20.3.9 NMAC.
PP. “Person” means:
(1) any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, government agency other than NRC or DOE, any state or any political subdivision of or any political entity within a state, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and
(2) any legal successor, representative, agent or agency of the foregoing.
QQ. “PET” means positron emission tomography.
RR. “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 (ABR), or the American board of health physics (ABHP), or the American board of medical physics (ABMP) or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the above qualifications, training and experience in the clinical applications of radiation physics to radiation therapy; for example, individuals certified in therapeutic radiological physics or x-ray and radium physics by the ABR, or those having equivalent qualifications. With reference to providing medical physics services to certified mammographic facilities, such individuals must meet the requirements as defined by the FDA.
SS. “Radiation” (ionizing radiation), as used in this chapter, means alpha particles, beta particles, gamma rays, x-rays, neutrons, high-speed electrons, high-speed protons and other particles capable of producing ions. Radiation, as used in this chapter, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared or ultraviolet light.
TT. “Radiation machine” means any device capable of producing radiation except those devices with radioactive material as the only source of radiation.
UU. “Radiation safety officer” means one who has the knowledge and responsibility to apply appropriate radiation protection regulations.
VV. “Radioactive material” means any material in any physical or chemical form which emits radiation spontaneously.
WW. “Radioactivity” means the transformation of unstable atomic nuclei by the emission of radiation.
XX. “Radioisotope” (see radioactive material).
YY. “Radionuclide” (see radioactive material).
ZZ. “Registrant” means a holder of a registration and any person who is registered or legally obligated to register with the department pursuant to 20.3.2 NMAC or 20.3.9 NMAC.
AAA. “Registration” (certificate of registration) means a registration issued by the department pursuant to 20.3.2 NMAC or 20.3.9 NMAC.
BBB. “Regulation” means any rule adopted pursuant to the act.
CCC. “Regulations of the U.S. department of transportation” (DOT) means the regulations in 49 CFR Parts 100-185.
DDD. “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. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.
EEE. “Sealed source” means any radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.
FFF. “Sealed source and device registry” means the national registry that contains all the registration certificates, generated by both NRC and the agreement states that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.
GGG. “Secretary” means the secretary of the New Mexico environment department.
HHH. “SI” means the international system of units.
III. “Site boundary” means that line beyond which the land or property is not owned, leased or otherwise controlled by the licensee or registrant.
JJJ. “Source material” means:
(1) uranium or thorium, or any combination thereof, in any physical or chemical form; or
(2) ores that contain by weight one-twentieth of one percent (0.05 percent) or more of uranium, thorium or any combination thereof; source material does not include special nuclear material.
KKK. “Source material milling” means any activity which results in the production of byproduct as defined in Paragraph (2) of Subsection F of this section.
LLL. “Source of radiation” means any radioactive material, device or equipment emitting or capable of producing radiation.
MMM. “Special form radioactive material” means radioactive material that satisfies the conditions in 10 CFR 71.75
NNN. “Special nuclear material” means:
(1) plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material which the NRC, pursuant to the provisions of Section 51 of the Atomic Energy Act determines to be special nuclear material, but does not include source material; or
(2) any material artificially enriched by any of the foregoing but does not include source material.
OOO. “Special nuclear material in quantities not sufficient to form a critical mass” means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams or any combination of them in accordance with the following formula: for each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1 (i.e. unity). For example, the following quantities in combination would not exceed the limitation and are within the formula: 175 (grams contained U-235)/350 + 50 (grams U-233)/200 + 50 (grams Pu)/200 = 1.
PPP. “Test” means a method for determining the characteristics of conditions of sources of radiation or components thereof.
QQQ. “These regulations” means all parts of 20.3 NMAC.
RRR. “Unrefined and unprocessed ore” means ore in its natural form prior to any processing such as grinding, roasting, beneficiating or refining.
SSS. “Waste” (radioactive waste) means those low-level radioactive wastes containing radioactive material which is acceptable for disposal in a land disposal facility. For the purposes of this chapter, excluded from the definition of “waste” are:
(1) high-level radioactive waste or spent nuclear fuel as defined in section 2 of the Nuclear Waste Policy Act;
(2) transuranic waste as defined in section 11.(ee) of the Atomic Energy Act; or
(3) byproduct material as defined in Paragraphs (2), (3), (4) and (5) of the definition of byproduct material set forth in this section.
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20.3.1.8 through 20.3.1.106 NMAC [RESERVED]
20.3.1.107 EXEMPTIONS FROM THE REGULATORY REQUIREMENTS:
A. General Provisions. The department may, upon application of any interested person or upon its own initiative, grant such exemptions from the requirements of this chapter as it determines are authorized by law, will not endanger public health and safety or property and are otherwise in the public interest.
B. DOE contractors and NRC contractors. Any DOE contractor or subcontractor and any NRC contractor or subcontractor of the following categories operating within this state is exempt from these regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers or acquires sources of radiation:
(1) prime contractors performing work for the DOE at United States government-owned or controlled sites, 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 DOE performing research in, or development, manufacture, storage, testing or transportation of atomic weapons or components thereof;
(3) prime contractors of the DOE using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and
(4) any other prime contractor or subcontractor of the DOE or NRC when the state and the NRC 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 thereunder can be accomplished without undue risk to the public health and safety.
C. Common and contract carriers, freight forwarders, warehousemen and United States postal service are exempt from the regulations in 10 CFR parts 31 through 37 and 39 as well as the requirements for a license set forth in section 81 of the Atomic Energy Act to the extent that they transport or store byproduct material in the regular course of carriage for another or storage incident thereto.
D. Mining, extracting, processing, storage or transportation of radioactive ores or uranium concentrates that are regulated by the mine safety and health administration (MSHA), United States department of labor (DOL), or any other federal or state agency having authority are exempt unless the authority is ceded by such agency to the board.
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20.3.1.108 RECORDS: Each licensee and registrant shall maintain records showing the receipt, transfer and disposal of all sources of radiation. Additional record requirements are specified elsewhere in these regulations.
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20.3.1.109 INSPECTIONS:
A. Each licensee and registrant shall afford the department at all reasonable times, opportunity 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 the department for inspection upon reasonable notice, records maintained pursuant to the requirements in this chapter.
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20.3.1.110 TESTS: Each licensee and registrant shall perform, or permit the department to perform such tests as the department deems appropriate or necessary for the administration of the requirements in this chapter, including, but not limited to, tests of:
A. sources of radiation;
B. facilities wherein sources of radiation are used or stored;
C. radiation detection and monitoring instruments; and
D. other equipment and devices used in connection with utilization or storage of sources of radiation.
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20.3.1.111 ADDITIONAL REQUIREMENTS: The department may impose upon a licensee or registrant such requirements in addition to those established in this chapter as it deems appropriate or necessary to minimize danger to public health and safety or property.
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20.3.1.112 VIOLATIONS:
A. Violation of any requirement of the act, this chapter or a license or registration condition may result in enforcement proceedings under Section 74-3-11.1, NMSA 1978, including, but not limited to, the following:
(1) issuing a compliance order or assessing a civil penalty of up to $ 15,000 per day for each violation or both; or
(2) commencing a civil action in district court for appropriate relief, including injunctive relief.
B. A person who knowingly commits a violation of any provision of the act, this chapter or order issued thereunder may be guilty of a misdemeanor under Section 74-3-12.1, NMSA 1978. A person who knowingly makes a false statement, representation or certification in an application, record, report, plan or other document filed or required to be maintained pursuant to the act or this chapter may be guilty of a petty misdemeanor under Section 74-3-12.1, NMSA 1978.
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20.3.1.113 IMPOUNDING: Sources of radiation shall be subject to impounding pursuant to the act.
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20.3.1.114 PROHIBITED USES:
A. A hand-held fluoroscopic screen shall not be used with x-ray equipment unless it has been listed in the registry of sealed sources and devices or accepted for certification by the FDA, or the center for devices and radiological health (CDRH).
B. A shoe-fitting fluoroscopic device shall not be used.
C. The use of a source of radiation for the purpose of screening or inspecting individuals for concealed weapons, hazardous materials, stolen property, illegal goods or contraband, is prohibited without prior written approval from the department.
D. The exposure of any individual to the primary beam of a radiation machine for training or demonstration purposes is prohibited.
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20.3.1.115 INTERPRETATIONS: Except as specifically authorized by the department in writing, no interpretation of these regulations by an officer or employee of the department other than a written interpretation by the legal counsel will be recognized to be binding upon the department.
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20.3.1.116 COMMUNICATIONS: All communications and reports concerning these regulations and applications filed thereunder should be addressed to the department at its office as follows: New Mexico environment department, radiation control bureau, P.O. Box 5469, Santa Fe, NM 87502-5469.
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20.3.1.117 through 20.3.1.120 [RESERVED]
20.3.1.121 DOCUMENTS AND FORMS:
A. All documents referenced in these regulations are available for review at the offices of the department's radiation control bureau.
B. All forms referenced in these regulations may be obtained for review at the offices of the department's radiation control bureau.
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20.3.1.122 DELIBERATE MISCONDUCT:
A. Any licensee, registrant, applicant for a license or registration, employee of a licensee, employee of a registrant or registration applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or registrant or applicant for a license or registration, who knowingly provides to any licensee, registrant, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's, registrant’s or applicant's activities in 20.3 NMAC, may not:
(1) engage in deliberate misconduct that causes or would have caused, if not detected, a licensee, registrant, or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license or registration issued by the department; or
(2) deliberately submit to the department, a licensee, registrant, an applicant, or a licensee's, registrant’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 the department.
B. A person who violates Paragraphs (1) or (2) of Subsection A of this section may be subject to enforcement action in accordance with all applicable provisions of the act and 20.3 NMAC.
C. For the purposes of Paragraph (1) of Subsection A of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:
(1) would cause a licensee, registrant or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license or registration issued by the department; or
(2) constitutes a violation of a requirement, procedure, instruction, contract, purchase order or policy of a licensee, registrant, applicant, contractor or subcontractor.
[20.3.1.122 NMAC - Rp, 20.3.1.122 NMAC, 4/30/2009]
20.3.1.123 COMPLETENESS AND ACCURACY OF INFORMATION:
A. Information provided to the department by an applicant for a license or registration, or by a licensee or registrant or information required by statute or by the department's regulations, orders, or license or registration conditions to be maintained by the applicant or the licensee or registrant shall be complete and accurate in all material respects.
B. Each applicant, licensee or registrant shall notify the department of information identified by the applicant, licensee or registrant as having for the regulated activity a significant implication for public health and safety. An applicant, licensee or registrant violates this paragraph only if the applicant, licensee or registrant fails to notify the department of information that the applicant, licensee or registrant has identified as having a significant implication for public health and safety. Notification shall be provided to the department within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the department by other reporting or updating requirements.
[20.3.1.123 NMAC - N, 4/30/2009]
20.3.1.124 SAVING CLAUSE: Amendment and supersession of this chapter shall not affect any administrative or judicial enforcement action pending on the effective date of such amendment nor the validity of any license or registration issued pursuant to this chapter.
[20.3.1.124 NMAC - N, 4/30/2009]
HISTORY of 20.3.1 NMAC:
Pre-NMAC History: The material in this part was derived from that previously filed as follows:
EIB 73-2, Regulations for Governing the Health and Environmental Aspects of Radiation filed on 7/9/1973;
EIB 73-2, Amendment 1, Regulations for Governing the Health and Environmental Aspects of Radiation filed on 4/17/1978;
EIB RPR-1, Radiation Protection Regulations filed on 4/21/1980;
EIB RPR-1, Amendment 1, Radiation Protection Regulations filed on 10/13/1981;
EIB RPR-1, Amendment 2, Radiation Protection Regulations filed on 12/15/1982; and
EIB RPR-1, Radiation Protection Regulations filed on 3/10/1989.
History of Repealed Material: 20.3.1 NMAC, General Provisions (filed 3/15/2004) repealed 4/30/2009.
Other History: EIB RPR 1, Radiation Protection Regulations (filed 3/10/1989) renumbered and reformatted to 20 NMAC 3.1, Radioactive Materials and Radiation Machines, effective 5/3/1995;
20 NMAC 3.1, Radioactive Materials and Radiation Machines (filed 4/3/1995) internally renumbered, reformatted and replaced by 20 NMAC 3.1, Radioactive Materials and Radiation Machines, effective 7/30/1999.
20 NMAC 3.1.Subpart 1, General (filed 6/17/1999) reformatted, amended and replaced by 20.3.1 NMAC, General Provisions, effective 4/15/2004.
20.3.1 NMAC, General Provisions (filed 3/15/2004) replaced by 20.3.1 NMAC, General Provisions, effective 4/30/2009.