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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 3701:1-50 | Packaging and Transportation of Radioactive Material

 
 
 
Rule
Rule 3701:1-50-01 | Definitions.
 

Terms defined in rule 3701:1-38-01 of the Administrative Code shall have the same meaning when used in this chapter except terms redefined within a given rule for use within that rule only, and additionally, as used in this chapter of the Administrative Code:

(A) "Carrier" means a person engaged in the transportation of passengers or property by land or water as a common, contract, or private carrier, or by civil aircraft.

(B) "Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the United States nuclear regulatory commission.

(C) "Certificate of compliance (CoC)" means the certificate issued by the United States nuclear regulatory commission under subpart D of 10 C.F.R. 71 (as in effect on the effective date of this rule) which approves the design of a package for the transportation of radioactive material.

(D) "Closed transport vehicle" means a transport vehicle equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the radioactive material. The enclosure may be temporary or permanent but shall limit access from top, sides, and ends. In the case of packaged materials, it may be of the "see-through" type.

(E) "Close reflection by water" means immediate contact by water of sufficient thickness for maximum reflection of neutrons.

(F) "Consignment" means each shipment of a package or groups of packages or load of radioactive material offered by a shipper for transport.

(G) "Containment system" means the assembly of components of the packaging intended to retain the radioactive material during transport.

(H) "Contamination" means the presence of a radioactive substance on a surface in quantities in excess of 0.4 becquerel per square centimeter (1x10-5microcurie per square centimeter) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 becquerel per square centimeter (1x10-6microcurie per square centimeter) for all other alpha emitters.

(1) Fixed contamination means contamination that cannot be removed from a surface during normal conditions of transport.

(2) Non-fixed contamination means contamination that can be removed from a surface during normal conditions of transport.

(I) "Conveyance" means:

(1) For transport by public highway or rail, any transport vehicle or large freight container;

(2) For transport by water, any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and

(3) For transport by air, any aircraft.

(J) "Criticality safety index (CSI)" means the dimensionless number (rounded up to the next tenth) assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages, overpacks or freight containers containing fissile material during transportation. Determination of the criticality safety index is described in rules 3701:1-50-11 and 3701:1-50-12 of the Administrative Code and 10 C.F.R. 71.59 (as in effect on the effective date of this rule). The criticality safety index for an overpack, freight container, consignment or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack, freight container, consignment or conveyance.

(K) "Deuterium" means, for the purpose of rules 3701:1-50-11 and 3701:1-50-13 of the Administrative Code, deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds one to five thousand.

(L) "DOT" means United States department of transportation.

(M) "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

(N) "Exclusive use" means the sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions, in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor.

(O) "Graphite" means, for the purposes of rules 3701:1-50-11 and 3701:1-50-13 of the Administrative Code, graphite with a boron equivalent content less than five parts per million and density greater than 1.5 grams per cubic centimeter.

(P) "Indian tribe" means an Indian or Alaska native tribe, band, nation, pueblo, village, or community that the secretary of the interior acknowledges to exist as an Indian tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, Pub.L. No. 103-454, 108 Stat. 4791, 25 U. S. C. 5130 (as in effect on the effective date of this rule).

(Q) "Low toxicity alpha emitters" means natural uranium, depleted uranium, natural thorium, uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than ten days.

(R) "Maximum normal operating pressure" means the maximum gauge pressure that would develop in the containment system in a period of one year under the heat condition specified in 10 C.F.R. 71.71(C)(1) (as in effect on the effective date of this rule), in the absence of venting, external cooling by an ancillary system, or operational controls during transport.

(S) "Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes or one hundred weight per cent thorium-232.

(T) "Natural uranium" means uranium (which may be chemically separated) with the naturally occurring distribution of uranium isotopes (approximately 0.711 weight per cent uranium-235, and the remainder by weight essentially uranium-238).

(U) "Optimum interspersed hydrogenous moderation" means the presence of hydrogenous material between packages to such an extent that the maximum nuclear reactivity results.

(V) "Specific activity of a radionuclide" means the radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

(W) "Spent nuclear fuel or spent fuel" means fuel that has been withdrawn from a nuclear reactor following irradiation, has undergone at least one year's decay since being used as a source of energy in a power reactor, and has not been chemically separated into its constituent elements by reprocessing. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive materials associated with fuel assemblies.

(X) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.

(Y) "Tribal official" means the highest ranking individual that represents tribal leadership of an Indian tribe, such as the chief, president, or tribal council leadership.

(Z) "Unirradiated uranium" means uranium containing not more than two thousand becquerels (fifty-four nanocuries) of plutonium per gram of uranium-235, not more than nine megabecquerels (two hundred forty-three microcuries) of fission products per gram of uranium-235, and not more than 0.005 grams of uranium-236 per gram of uranium-235.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001, 2/13/2014, 2/18/2016
Rule 3701:1-50-02 | Purpose and scope.
 

(A) This chapter establishes requirements for packaging, preparation for shipment, and transportation of radioactive material.

(B) The packaging and transport of radioactive material are also subject to other chapters of the Administrative Code and to the regulations of other agencies (such as the DOT, the United States postal service and the United States nuclear regulatory commission) having jurisdiction over means of transport. The requirements of this chapter are in addition to, and not in substitution for, other requirements.

(C) This chapter applies to any licensee authorized by specific or general license issued by the director to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the Ohio license, or transports that material on public highways. No provision of this chapter authorizes possession of licensed material.

(D) Exemptions from the requirement for license in rule 3701:1-50-04 of the Administrative Code are specified in rule 3701:1-50-06 of the Administrative Code. General licenses for which no package approval is required are issued in rules 3701:1-50-10 to 3701:1-50-12 of the Administrative Code. The general license in rule 3701:1-50-07 of the Administrative Code requires that an United States nuclear regulatory commission CoC or other package approval be issued for the package to be used under the general license. The transport of licensed material or delivery of licensed material to a carrier for transport is subject to the operating controls and procedures requirements of rules 3701:1-50-15 to 3701:1-50-19 and rule 3701:1-50-23 of the Administrative Code, to the quality assurance requirements of rule 3701:1-50-24 of the Administrative Code or United States nuclear regulatory commission, and to the general provisions of rules 3701:1-50-01 to 3701:1-50-05 of the Administrative Code, including DOT regulations referenced in rule 3701:1-50-05 of the Administrative Code.

(E) These rules apply to any person required to obtain a CoC or an approved compliance plan from the United States nuclear regulatory commission pursuant to 10 C.F.R. 76 (as in effect on the effective date of this rule) if the person delivers radioactive material to a common or contract carrier for transport or transports the material outside the confines of the person's plant or other authorized place of use.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 9/1/2011
Rule 3701:1-50-03 | Communications and records.
 

(A) Except as otherwise specified, all communications required by this chapter shall be addressed to the bureau of environmental health and radiation protection at:

"Ohio Department of Health

246 North High Street

Bureau of Environmental Health and Radiation Protection

Columbus, Ohio 43215"

If communications are required to be submitted to the United States nuclear regulatory commission use the following address: the director, office of nuclear material safety and safeguards, United States nuclear regulatory commission, Washington, D.C. 20555-0001, or may be delivered in person, at the commission offices, at 11545 Rockville Pike, Rockville, Maryland.

(B) Each record required by this chapter must be legible throughout the retention period specified by each rule. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Rule 3701:1-50-04 | Requirement for license.
 

Except as authorized in a general license or a specific license issued by the director, or as exempted in this chapter, no licensee may:

(A) Deliver licensed material to a carrier for transport; or

(B) Transport licensed material.

Last updated June 13, 2021 at 10:03 AM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001
Rule 3701:1-50-05 | Transportation of licensed material.
 

(A) Each licensee who transports licensed material outside the site of usage, as specified in the United States nuclear regulatory commission or Ohio license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of the DOT regulations in 49 C.F.R. 107, 171 to 180, and 390 to 397 (as in effect on the effective date of this rule), appropriate to the mode of transport.

(1) The licensee shall particularly note DOT regulations (as in effect on the effective date of this rule) in the following areas:

(a) Packaging - 49 C.F.R. 173: subparts A, B, and I.

(b) Marking and labeling - 49 C.F.R. 172: subpart D; sections 172.400 to 172.407 and 172.436 to 172.441 of subpart E.

(c) Placarding - 49 C.F.R. 172: subpart F, especially sections 172.500 to 172.519 and 172.556; and appendices B and C.

(d) Accident reporting - 49 C.F.R. 171: sections 171.15 and 171.16.

(e) Shipping papers and emergency information - 49 C.F.R. 172: subparts C and G.

(f) Hazardous material employee training - 49 C.F.R. 172: subpart H.

(g) Security plans - 49 C.F.R. 172: subpart I.

(h) Hazardous material shipper/carrier registration - 49 C.F.R. 107: subpart G.

(2) The licensee shall also note DOT regulations (as in effect on the effective date of this rule) pertaining to the following modes of transportation:

(a) Rail - 49 C.F.R. 174: subparts A to D and K.

(b) Air - 49 C.F.R. 175.

(c) Vessel - 49 C.F.R. 176: subparts A to F and M.

(d) Public highway - 49 C.F.R. 177 and 390 to 397.

(B) If DOT regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the DOT specified in paragraph (A) of this rule to the same extent as if the shipment or transportation were subject to DOT regulations. A request for modification, waiver, or exemption from those requirements, and any notification referred to in those requirements, must be filed with, or made to, the director, Ohio department of health.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001
Rule 3701:1-50-06 | Exemption for low-level materials.
 

(A) A licensee is exempt from all the requirements of this chapter with respect to shipment or carriage of the following low-level materials:

(1) Natural material and ores containing naturally occurring radionuclides that are either in their natural state, or have only been processed for purposes other than for the extraction of the radionuclides, and which are not intended to be processed for the use of these radionuclides, provided the activity concentration of the material does not exceed ten times the applicable radionuclide activity concentration values specified in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, or table 25-3 in appendix C to rule 3701:1-50-25 of the Administrative Code.

(2) Materials for which the activity concentration is not greater than the activity concentration values specified in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, or table 25-3 in appendix C to rule 3701:1-50-25 of the Administrative Code, or for which the consignment activity is not greater than the limit for an exempt consignment found in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, or table 25-3 in appendix C to rule 3701:1-50-25 of the Administrative Code.

(3) Non-radioactive solid objects with radioactive substances present on any surfaces in quantities not in excess of the levels cited in the definition of contamination in rule 3701:1-50-01 of the Administrative Code.

(B) A licensee is exempt from all the requirements of this chapter, other than rules 3701:1-50-05 and 3701:1-50-18 of the Administrative Code, with respect to shipment or carriage of the following packages, provided the packages do not contain any fissile material, or the material is exempt from classification as fissile material under 3701:1-50-13 of the Administrative Code:

(1) A package that contains no more than a Type A quantity of radioactive material;

(2) A package transported within the United States that contains no more than 0.74 terabecquerel (twenty curies) of special form plutonium-244; or

(3) The package contains only LSA or SCO radioactive material, provided:

(a) That the LSA or SCO material has an external radiation dose of less than or equal to ten millisievert per hour (one rem per hour), at a distance of three meters from the unshielded material; or

(b) That the package contains only LSA-I or SCO-I material.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001, 10/22/2006
Rule 3701:1-50-07 | General license: NRC-approved package.
 

(A) A general license is hereby issued to any Ohio licensee to transport, or to deliver to a carrier for transport, licensed material in a package for which a license, CoC, or other approval has been issued by the United States nuclear regulatory commission.

(B) This general license applies only to a licensee who has a quality assurance program approved by the director as satisfying the provisions of this chapter.

(C) Each licensee issued a general license under paragraph (A) of this rule shall:

(1) Maintain a copy of the CoC, or other approval of the package, and the drawings and other documents referenced in the approval relating to the use and maintenance of the packaging and to the actions to be taken before shipment;

(2) Comply with the terms and conditions of the license, certificate, or other approval, as applicable, and the applicable requirements of this chapter; and

(3) Submit in writing before the first use of the package to:

"Attn: Document Control Desk

Director, Division of Fuel Management

Office of Nuclear Material Safety and Safeguards"

using an appropriate method listed in 10 C.F.R. 71.1(a) (as in effect on the effective date of this rule), the licensee's name and license number and the package identification number specified in the package approval.

(D) This general license applies only when the package approval authorizes use of the package under this general license.

(E) For a type B or fissile material package, the design of which was approved by the United States nuclear regulatory commission before April 1, 1996, the general license is subject to the additional restrictions of 10 C.F.R. 71.19 (as in effect on the effective date of this rule).

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 4/20/2018
Rule 3701:1-50-10 | General license: use of foreign approved package.
 

(A) A general license is issued to any Ohio licensee to transport, or to deliver to a carrier for transport, licensed material in a package the design of which has been approved in a foreign national competent authority certificate that has been revalidated by DOT as meeting applicable requirements of 49 C.F.R. 171.23 (as in effect on the effective date of this rule).

(B) Except as otherwise provided in this chapter, the general license applies only to a Ohio licensee who has a quality assurance program approved by the director as satisfying the applicable provisions of this chapter.

(C) This general license applies to only shipments made to or from locations outside the United States.

(D) Each licensee issued a general license under paragraph (A) of this rule shall:

(1) Maintain a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate, relating to the use and maintenance of the packaging and to the actions to be taken before shipment; and

(2) Comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of this chapter.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 9/1/2011
Rule 3701:1-50-11 | General license: Fissile material.
 

(A) A general license is issued to any licensee of the department to transport fissile material, or to deliver fissile material to a carrier for transport, if the material is shipped in accordance with this section. The fissile material need not be contained in a package which meets the standards of subparts E and F of 10 C.F.R. 71 (as published in the January 1, 2014 Code of Federal Regulations); however, the material must be contained in a type A package. The type A package must also meet the DOT requirements of 49 C.F.R. 173.417(a) (as published in the October 1, 2014 Code of Federal Regulations).

(B) The general license applies only to a licensee who has a quality assurance program approved by the department as satisfying the provisions of rule 3701:1-50-24 of the Administrative Code.

(C) The general license applies only when a package's contents:

(1) Contain no more than a type A quantity of radioactive material; and

(2) Contain less than five hundred total grams of beryllium, graphite, or hydrogenous material enriched in deuterium.

(D) The general license applies only to packages containing fissile material that are labeled with a CSI which:

(1) Has been determined in accordance with paragraph (E) of this rule;

(2) Has a value less than or equal to ten; and

(3) For a shipment of multiple packages containing fissile material, the sum of the CSIs must be less than or equal to fifty (for shipment on a nonexclusive use conveyance) and less than or equal to one hundred (for shipment on an exclusive use conveyance).

(E)

(1) The value for the CSI must be greater than or equal to the number calculated by the following equation:

CSI = 10((grams of U-235/X) + (grams of U-233/Y) + (grams of Pu/Z))

(2) The calculated CSI must be rounded up to the first decimal place;

(3) The values of X, Y, and Z used in the CSI equation must be taken from table 11-1 or table 11-2, as appropriate;

(4) If table 11-2 is used to obtain the value of X, then the values for the terms in the equation for uranium-233 and plutonium must be assumed to be zero; and

(5) Table 11-1 values for X, Y, and Z must be used to determine the CSI if:

(a) Uranium-233 is present in the package;

(b) The mass of plutonium exceeds one per cent of the mass of uranium-235;

(c) The uranium is of unknown uranium-235 enrichment or greater than twenty-four weight per cent enrichment; or

(d) Substances having a moderating effectiveness (i.e., an average hydrogen density greater than H2O) (e.g., certain hydrocarbon oils or plastics) are present in any form, except as polyethylene used for packing or wrapping.

FissilematerialFissile material mass mixedwith moderating substances having an average hydrogen density less than orequal to H2O (grams)Fissile material mass mixed with moderatingsubstances having an average hydrogen density greater than H2Oa(grams)
U-235(X)6038
U-233(Y)4327
Pu-239or Pu-241 (Z)3724

a When mixtures of moderating substances are present, the lower mass limits shall be used if more than fifteen per cent of the moderating substance has an average hydrogen density greater than H2O.

Uranium enrichment in weight per cent of U-235 notexceedingFissile material mass ofU-235 (X) (grams)
2460
2063
1567
1172
1076
9.578
981
8.582
885
7.588
790
6.593
697
5.5102
5108
4.5114
4120
3.5132
3150
2.5180
2246
1.5408
1.35480
11,020
0.921,800

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Rule 3701:1-50-12 | General license: plutonium-beryllium special form material.
 

(A) A general license is issued to any licensee of the department to transport fissile material in the form of plutonium-beryllium (Pu-Be) special form sealed sources, or to deliver Pu-Be sealed sources to a carrier for transport, if the material is shipped in accordance with this section. This material need not be contained in a package which meets the standards of subparts E and F of 10 C.F.R. 71 (as published in the January 1, 2014 Code of Federal Regulations); however, the material must be contained in a type A package. The type A package must also meet the DOT requirements of 49 C.F.R. 173.417(a) (as published in the October 1, 2014 Code of Federal Regulations).

(B) The general license applies only to a licensee who has a quality assurance program approved by the department as satisfying the provisions of rule 3701:1-50-24 of the Administrative Code.

(C) The general license applies only when a package's contents:

(1) Contain no more than a type A quantity of radioactive material; and

(2) Contain less than one thousand grams of plutonium, provided that: plutonium-239, plutonium-241, or any combination of these radionuclides, constitutes less than two hundred forty grams of the total quantity of plutonium in the package.

(D) The general license applies only to packages labeled with a CSI which:

(1) Has been determined in accordance with paragraph (E) of this rule;

(2) Has a value less than or equal to one hundred; and

(3) For a shipment of multiple packages containing Pu-Be sealed sources, the sum of the CSIs must be less than or equal to fifty (for shipment on a nonexclusive use conveyance) and less than or equal to one hundred (for shipment on an exclusive use conveyance).

(E)

(1) The value for the CSI must be greater than or equal to the number calculated by the following equation:

CSI = 10 ((grams of Pu-239 + grams of Pu-241) / 24); and

(2) The calculated CSI must be rounded up to the first decimal place.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 9/1/2011
Rule 3701:1-50-13 | Exemption from classification as fissile material.
 

Fissile material meeting the requirements of at least one of the paragraphs (A) to (F) of this rule are exempt from classification as fissile material and from the fissile material package standards of 10 C.F.R. 71.55 and 10 C.F.R. 71.59 (as published in the January 1, 2017 Code of Federal Regulations), but are subject to all other requirements of this chapter, except as noted.

(A) Individual package containing two grams or less fissile material.

(B) Individual or bulk packaging containing fifteen grams or less of fissile material provided the package has at least two hundred grams of solid nonfissile material for every gram of fissile material. Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass for solid nonfissile material.

(C)

(1) Low concentrations of solid fissile material commingled with solid nonfissile material, provided that:

(a) There is at least two thousand grams of solid nonfissile material for every gram of fissile material, and

(b) There is no more than one hundred eighty grams of fissile material distributed within three hundred sixty kilograms of contiguous nonfissile material.

(2) Lead, beryllium, graphite, and hydrogenous material enriched in deuterium may be present in the package but must not be included in determining the required mass of solid nonfissile material.

(D) Uranium enriched in uranium-235 to a maximum of one per cent by weight, and with total plutonium and uranium-233 content of up to one per cent of the mass of uranium-235, provided that the mass of any beryllium, graphite, and hydrogenous material enriched in deuterium constitutes less than five per cent of the uranium mass, and that the fissile material is distributed homogeneously and does not form a lattice arrangement within the package.

(E) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two per cent by mass, with a total plutonium and uranium-233 content not exceeding 0.002 per cent of the mass of uranium, and with a minimum nitrogen to uranium atomic ratio (N/U) of two. The material must be contained in at least DOT type A package.

(F) Packages containing, individually, a total plutonium mass of not more than one thousand grams, of which not more than twenty per cent by mass may consist of plutonium-239, plutonium-241, or any combination of these radionuclides.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 9/1/2011
Rule 3701:1-50-15 | Assumptions as to unknown properties.
 

When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

Last updated June 13, 2021 at 10:04 AM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001
Rule 3701:1-50-16 | Preliminary determinations.
 

Before the first use of any packaging for the shipment of licensed material, the licensee shall ascertain that the determinations in paragraphs (a) through (c) of 10 C.F.R. 71.85 (as published in the January 1, 2017 Code of Federal Regulations) have been made.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001, 10/22/2006
Rule 3701:1-50-17 | Routine determinations.
 

Before each shipment of licensed material, the licensee shall ensure that the package with its contents satisfies the applicable requirements of this chapter and of the license. The licensee shall determine that:

(A) The package is proper for the contents to be shipped;

(B) The package is in unimpaired physical condition except for superficial defects such as marks or dents;

(C) Each closure device of the packaging, including any required gasket, is properly installed and secured and free of defects;

(D) Any system for containing liquid is adequately sealed and has adequate space or other specified provision for expansion of the liquid;

(E) Any pressure relief device is operable and set in accordance with written procedures;

(F) The package has been loaded and closed in accordance with written procedures;

(G) For fissile material, any moderator or neutron absorber, if required, is present and in proper condition;

(H) Any structural part of the package that could be used to lift or tie down the package during transport is rendered inoperable for that purpose, unless it satisfies the design requirements of 10 C.F.R. 71.45 (as published in the January 1, 2014 Code of Federal Regulations).

(I) The level of non-fixed or removable radioactive contamination on the external surfaces of each package offered for shipment is as low as reasonably achievable and within the limits as specified in DOT regulations in 49 C.F.R. 173.443 (as published in the January 1, 2014 Code of Federal Regulations).

(J) External radiation levels around the package, and around the vehicle if applicable, will not exceed the limits specified in this paragraph at any time during transportation:

(1) Except as provided in paragraph (J)(2) of this rule, each package of radioactive materials offered for transportation must be designed and prepared for shipment so that under conditions normally incident to transportation the radiation level does not exceed two millisievert per hour (two hundred millirem per hour) at any point on the external surface of the package, and the transport index does not exceed ten;

(2) A package that exceeds the radiation level limits specified in paragraph (J)(1) of this rule must be transported by exclusive use shipment only, and the radiation levels for such shipment must not exceed the following during transportation:

(a) Two millisievert per hour (two hundred millirem per hour) on the external surface of the package, unless the following conditions are met, in which case the limit is ten millisievert per hour (one thousand millirem per hour):

(i) The shipment is made in a closed transport vehicle;

(ii) The package is secured within the vehicle so that its position remains fixed during transportation; and

(iii) There are no loading or unloading operations between the beginning and end of the transportation;

(b) Two millisievert per hour (two hundred millirem per hour) at any point on the outer surface of the vehicle, including the top and underside of the vehicle; or in the case of a flat-bed style vehicle, at any point on the vertical planes projected from the outer edges of the vehicle, on the upper surface of the load or enclosure, if used, and on the lower external surface of the vehicle; and

(c) 0.1 millisievert per hour (ten millirem per hour) at any point two meters (6.6 feet) from the outer lateral surfaces of the vehicle (excluding the top and underside of the vehicle); or in the case of a flat-bed style vehicle, at any point two meters (6.6 feet) from the vertical planes projected by the outer edges of the vehicle (excluding the top and underside of the vehicle); and

(d) 0.02 millisievert per hour (two millirem per hour) in any normally occupied space, except that this provision does not apply to private carriers, if exposed personnel under their control wear radiation dosimetry devices in conformance with rule 3701:1-38-14 of the Administrative Code.

(3) For shipments made under the provisions of paragraph (J)(2) of this rule, the shipper shall provide specific written instructions to the carrier for maintenance of the exclusive use shipment controls. The instructions must be included with the shipping paper information.

(4) The written instructions required for exclusive use shipments must be sufficient so that, when followed, they will cause the carrier to avoid actions that will unnecessarily delay delivery or unnecessarily result in increased radiation levels or radiation exposures to transport workers or members of the general public; and

(K) Accessible package surface temperatures will not exceed the limits specified in 10 C.F.R. 71.43(g) (as published in the January 1, 2014 Code of Federal Regulations) at any time during transportation.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001, 10/22/2006, 9/1/2011
Rule 3701:1-50-18 | Air transport of plutonium.
 

(A) Notwithstanding the provisions of any general licenses and notwithstanding any exemptions stated directly in this chapter or included indirectly by citation of 49 C.F.R. chapter I (as published in the October 1, 2014 Code of Federal Regulations), as may be applicable, the licensee shall assure that plutonium in any form, whether for import, export, or domestic shipment, is not transported by air or delivered to a carrier for air transport unless:

(1) The plutonium is contained in a medical device designed for individual human application; or

(2) The plutonium is contained in a material in which the specific activity is less than or equal to the activity concentration values for plutonium specified in table 25-2 in appendix B to rule 3701:1-50-25 of the Administrative Code, and in which the radioactivity is essentially uniformly distributed; or

(3) The plutonium is shipped in a single package containing no more than an A2 quantity of plutonium in any isotope or form, and is shipped in accordance with rule 3701:1-50-05 of the Administrative Code; or

(4) The plutonium is shipped in a package specifically authorized for the shipment of plutonium by air in the CoC for that package issued by the United States nuclear regulatory commission.

(B) Nothing in paragraph (A) of this rule is to be interpreted as removing or diminishing the requirements of 10 C.F.R. 73.24 (as published in the January 1, 2014 Code of Federal Regulations).

(C) For a shipment of plutonium by air which is subject to paragraph (A)(4) of this rule, the licensee shall, through special arrangement with the carrier, require compliance with 49 C.F.R. 175.704 (as published in the October 1, 2014 Code of Federal Regulations), DOT regulations applicable to the air transport of plutonium.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001
Rule 3701:1-50-19 | Opening instructions.
 

Before delivery of a package to a carrier for transport, the licensee shall ensure that any special instructions needed to safely open the package have been sent to, or otherwise made available to, the consignee for the consignee's use in accordance with paragraph (I) of rule 3701:1-38-18 of the Administrative Code.

Last updated June 13, 2021 at 10:04 AM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/22/2006
Rule 3701:1-50-20 | Records.
 

(A) Each licensee shall maintain, for a period of three years after shipment, a record of each shipment of licensed material not exempt under rule 3701:1-50-06 of the Administrative Code, showing where applicable:

(1) Identification of the packaging by model number and serial number;

(2) Verification that there are no significant defects in the packaging, as shipped;

(3) Volume and identification of coolant;

(4) Type and quantity of licensed material in each package, and the total quantity of each shipment;

(5) For each item of irradiated fissile material;

(a) Identification by model number and serial number;

(b) Irradiation and decay history to the extent appropriate to demonstrate that its nuclear and thermal characteristics comply with license conditions; and

(c) Any abnormal or unusual condition relevant to radiation safety;

(6) Date of the shipment;

(7) For fissile packages and for type B packages, any special controls exercised;

(8) Name and address of the transferee;

(9) Address to which the shipment was made; and

(10) Results of the determinations required by rule 3701:1-50-17 of the Administrative Code and by the conditions of the package approval.

(B) The licensee shall make available to the department for inspection, upon reasonable notice, all records required by this chapter. Records are only valid if stamped, initialed, or signed and dated by authorized personnel, or otherwise authenticated.

(C) The licensee shall maintain sufficient written records to furnish evidence of the quality of packaging. The records to be maintained include results of the determinations required by rule 3701:1-50-16 of the Administrative Code; design, fabrication, and assembly records; results of reviews, inspections, tests, and audits; results of monitoring work performance and materials analyses; and results of maintenance, modification, and repair activities. Inspection, test, and audit records must identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. These records must be retained for three years after the life of the packaging to which they apply.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Rule 3701:1-50-23 | Advance notification of shipment of irradiated reactor fuel and nuclear waste.
 

(A)

(1) As specified in paragraphs (B), (C) and (D) of this rule, each licensee shall provide advance notification to the governor of a state, or the governor's designee, of the shipment of licensed material, through, or across the boundary of the state, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage in compliance with section 4163.07 of the Revised Code.

(2) As specified in paragraphs (B), (C), and (D) of this rule, each licensee shall provide advance notification to the tribal official of participating indian tribes referenced in paragraph (C)(3)(c) of this rule, or the official's designee, of the shipment of licensed material, within or across the boundary of the indian tribe's reservation, before the transport, or delivery to a carrier, for transport, of licensed material outside the confines of the licensee's plant or other place of use or storage in compliance with section 4163.07 of the Revised Code.

(B) Advance notification is also required under this rule for shipments of licensed material, other than irradiated reactor fuel, meeting the following three conditions:

(1) The licensed material is required by this part to be in type B packaging for transportation;

(2) The licensed material is being transported to or across a state boundary in route to a disposal facility or to a collection point for transport to a disposal facility; and

(3) The quantity of licensed material in a single package exceeds the least of the following:

(a) Three thousand times the A1 value of the radionuclides as specified in rule 3701:1-50-25 of the Administrative Code for special form radioactive material;

(b) Three thousand times the A2 value of the radionuclides as specified in rule 3701:1-50-25 of the Administrative Code for normal form radioactive material; or

(c) One thousand terabecquerels (twenty-seven thousand curies).

(C) Each licensee shall submit an advance notification as follows:

(1) The notification must be made in writing to the office of each appropriate governor or governor's designee, the office of each appropriate tribal official or tribal officials designee, and to the director, division of security policy, office of nuclear security and incident response, United States nuclear regulatory commission.

(2) A notification delivered by mail must be postmarked at least seven days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(3) A notification delivered by any other means than mail must reach the office of the governor or of the governor's designee or the tribal official or tribal officials designee at least four days before the beginning of the seven-day period during which departure of the shipment is estimated to occur.

(a) A list of the names and mailing addresses of the governors' designees receiving advance notification of transportation of nuclear waste was published in the federal register on June 30, 1995 (60 FR 34306).

(b) Contact information for each state, including telephone and mailing addresses of governors and governors' designees, and participating tribes, including telephone and mailing addresses of tribal officials and tribal official's designees, is available on the United States nuclear regulatory commission's web site at: https://scp.nrc.gov/special/designee.pdf.

(c) A list of the names and mailing addresses of the governors' designees and tribal officials designees of participating tribes is available on request from the "Director, Division of Material Safety, State, Tribal, and Rulemaking Programs, Office of Nuclear Material Safety and Safeguards, United States Nuclear Regulatory Commission, Washington, DC 20555-0001."

(4) The licensee shall retain a copy of the notification as a record for three years.

(D) Each advance notification of shipment of nuclear waste must contain the following information:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the nuclear waste shipment;

(2) A description of the nuclear waste contained in the shipment, as specified in the regulation of DOT in 49 C.F.R. 172.202 and 49 C.F.R. 172.203(D) (as published in the October 1, 2016 Code of Federal Regulations);

(3) The point of origin of the shipment and the seven-day period during which departure of the shipment is estimated to occur;

(4) The seven-day period during which arrival of the shipment at state boundaries, or tribal reservation boundaries is estimated to occur;

(5) The destination of the shipment, and the seven-day period during which arrival at the destination of the shipment is estimated to occur; and

(6) A point of contact, with a telephone number, for current shipment information.

(E) Revision notice.

(1) A licensee who finds that schedule information previously furnished to a governor or governor's designee or a tribal official or tribal officials designee, in accordance with this section, will not be met, shall telephone a responsible individual in the office of the governor of the state or of the governor's designee or the tribal official or the tribal officials designee and inform that individual of the extent of the delay beyond the schedule originally reported. The licensee shall maintain a record of the name of the individual contacted for three years.

(F) Cancellation notice.

(1) Each licensee who cancels a nuclear waste shipment for which advance notification has been sent shall send a cancellation notice to the offices listed in paragraph (A) of this rule previously notified, and to the director, division of nuclear security, office of security policy and incident response, United States nuclear regulatory commission.

(2) The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled. The licensee shall retain a copy of the notice as a record for three years.

Supplemental Information

Authorized By: RC 3748.04
Amplifies: RC 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001
Rule 3701:1-50-24 | Quality assurance requirements.
 

(A) This rule describes quality assurance requirements applying to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this rule, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. . Each licensee is responsible for satisfying the quality assurance requirements that apply to its use of a packaging for the shipment of licensed material subject to this rule.

(B) Each licensee shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of this chapter and satisfying any specific provisions that are applicable to the licensee's activities including procurement of packaging. The licensee shall execute the applicable criteria in a graded approach to an extent that is commensurate with the quality assurance requirement's importance to safety.

(C) Before the use of any package for the shipment of licensed material subject to this rule, each licensee shall obtain the director's approval of its quality assurance program. Each licensee shall file a description of its quality assurance program, including a discussion of which requirements of this chapter are applicable and how they will be satisfied, by submitting the description to the address in rule 3701:1-50-03 of the Administrative Code.

(D) A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting these devices and meeting the requirements of paragraph (B) of rule 3701:1-48-11 of the Administrative Code or equivalent United States nuclear regulatory commission or agreement state requirements, is deemed to satisfy the requirements of paragraph (B) of rule 3701:1-50-07 of the Administrative Code and paragraph (B) of this rule.

(E) The licensee shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the program. These activities include performing the functions associated with attaining quality objectives and the quality assurance functions.

(F) The quality assurance functions are:

(1) Assuring that an appropriate quality assurance program is established and effectively executed; and

(2) Verifying, by procedures such as checking, auditing, and inspection, that activities affecting the functions that are important to safety have been correctly performed.

(G) The persons and organizations performing quality assurance functions must have sufficient authority and organizational freedom to:

(1) Identify quality problems;

(2) Initiate, recommend, or provide solutions; and

(3) Verify implementation of solutions.

(H) The persons and organizations performing quality assurance functions shall report to a management level that assures that the required authority and organizational freedom, including sufficient independence from cost and schedule, when opposed to safety considerations, are provided.

(I) Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom.

(J) Irrespective of the organizational structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program, at any location where activities subject to this section are being performed, must have direct access to the levels of management necessary to perform this function.

(K) The licensee shall establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a quality assurance program that complies with the requirements of this chapter. The licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.

(L) The licensee, through its quality assurance program, shall provide control over activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. The licensee shall assure that activities affecting quality are accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The licensee shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test.

(M) The licensee shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components:

(1) The impact of malfunction or failure of the item to safety;

(2) The design and fabrication complexity or uniqueness of the item;

(3) The need for special controls and surveillance over processes and equipment;

(4) The degree to which functional compliance can be demonstrated by inspection or test; and

(5) The quality history and degree of standardization of the item.

(N) The licensee shall provide for orientation and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained. The licensee shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program shall review regularly the status and adequacy of that part of the quality assurance program they are executing.

(O) Each quality assurance program approval holder shall submit, in accordance with rule 3701:1-50-03 of the Administrative Code, a description of a proposed change to its director approved quality assurance program that will reduce commitments in the program description as approved by the director. The quality assurance program approval holder shall not implement the change before receiving director approval. The description of a proposed change to the director approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of this chapter.

(P) Each quality assurance program approval holder may change a previously approved quality assurance program without prior director approval, if the change does not reduce the commitments in the quality assurance program previously approved by the director. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the director every twenty four months, in accordance with rule 3701:1-50-03 of the Administrative Code. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

(1) The use of a quality assurance standard approved by the director that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change. The use of a quality assurance standard approved by the director that is more recent than the quality assurance standard in the licensee's current quality assurance program at the time of the change;

(2) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities;

(3) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities;

(4) The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record; and

(5) Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

(Q) Each quality assurance program approval holder shall maintain records of quality assurance program changes.

(R) The licensee shall maintain sufficient written records to describe the activities affecting quality. These records must include changes to the quality assurance program as required by this chapter, the instructions, procedures, and drawings required by 10 C.F.R. 71.111 (as published in the January 1, 2017 Code of Federal Regulations) to prescribe quality assurance activities, and closely related specifications such as required qualifications of personnel, procedures, and equipment. The records must include the instructions or procedures that establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee shall retain these records for three years beyond the date when the licensee last engage in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee shall retain the superseded material for three years after it is superseded.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/22/2006
Rule 3701:1-50-25 | Determination of A1 and A2 values for radionuclides.
 
This rule was filed with the Legislative Service Commission in PDF format and is presented here as filed.
View Rule Text

View Appendix

Last updated June 2, 2021 at 3:29 PM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/22/2006, 9/1/2011
Rule 3701:1-50-26 | Exemption of physicians.
 

Any physician licensed by the state of Ohio to dispense drugs in the practice of medicine is exempt from rule 3701:1-50-05 of the Administrative Code with respect to transport by the physician of licensed material for use in the practice of medicine. However, any physician operating under this exemption must be licensed under Chapter 3701:1-58 of the Administrative Code, or equivalent regulations of the United States nuclear regulatory commission or an agreement state.

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.04
Five Year Review Date: 2/15/2026
Prior Effective Dates: 10/19/2001