This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 3701:1-50-01 | Definitions.
Effective:
February 15, 2021
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.
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Rule 3701:1-50-02 | Purpose and scope.
Effective:
February 15, 2021
(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.
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Rule 3701:1-50-03 | Communications and records.
Effective:
February 18, 2016
(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.
Last updated November 2, 2022 at 2:43 PM
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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
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Rule 3701:1-50-05 | Transportation of licensed material.
Effective:
February 15, 2021
(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.
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Rule 3701:1-50-06 | Exemption for low-level materials.
Effective:
April 20, 2018
(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.
Last updated November 2, 2022 at 2:43 PM
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Rule 3701:1-50-07 | General license: NRC-approved package.
Effective:
February 15, 2021
(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).
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Rule 3701:1-50-10 | General license: use of foreign approved package.
Effective:
February 15, 2021
(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.
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Rule 3701:1-50-11 | General license: Fissile material.
Effective:
February 15, 2021
(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 in effect on
the effective date of this rule); 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 in effect on the effective date of this
rule). (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. | Fissile material | Fissile material mass mixed with moderating substances having an average hydrogen density less than or equal to H2O (grams) | Fissile material mass mixed with moderating substances having an average hydrogen density greater than H2Oa(grams) | | U-235(X) | 60 | 38 | | U-233(Y) | 43 | 27 | | Pu-239 or Pu-241 (Z) | 37 | 24 |
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 not exceeding | Fissile material mass of U-235 (X) (grams) | | 24 | 60 | | 20 | 63 | | 15 | 67 | | 11 | 72 | | 10 | 76 | | 9.5 | 78 | | 9 | 81 | | 8.5 | 82 | | 8 | 85 | | 7.5 | 88 | | 7 | 90 | | 6.5 | 93 | | 6 | 97 | | 5.5 | 102 | | 5 | 108 | | 4.5 | 114 | | 4 | 120 | | 3.5 | 132 | | 3 | 150 | | 2.5 | 180 | | 2 | 246 | | 1.5 | 408 | | 1.35 | 480 | | 1 | 1,020 | | 0.92 | 1,800 |
Last updated March 6, 2024 at 11:40 AM
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Rule 3701:1-50-12 | General license: plutonium-beryllium special form material.
Effective:
February 15, 2021
(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 in effect on
the effective date of this rule); 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 in effect on the effective date of this
rule). (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.
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Rule 3701:1-50-13 | Exemption from classification as fissile material.
Effective:
February 15, 2021
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 in effect on the effective
date of this rule), 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.
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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
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Rule 3701:1-50-16 | Preliminary determinations.
Effective:
February 15, 2021
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 in effect
on the effective date of this rule) have been made.
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Rule 3701:1-50-17 | Routine determinations.
Effective:
February 15, 2021
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 in effect on the effective date of this rule). (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 in effect on the effective date of
this rule). (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 in
effect on the effective date of this rule) at any time during
transportation.
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Rule 3701:1-50-18 | Air transport of plutonium.
Effective:
February 15, 2021
(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 in effect
on the effective date of this rule), 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 in effect on the effective date of this rule). (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 in effect on the effective date of this rule), DOT regulations applicable
to the air transport of plutonium.
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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
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Rule 3701:1-50-20 | Records.
Effective:
April 20, 2018
(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.
Last updated November 2, 2022 at 2:44 PM
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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 official's designee, and to the director, 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
official's designee at least four days before the beginning of the
seven-day period during which departure of the shipment is estimated to
occur. (a) 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. (b) 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, Security, State, and Tribal 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 in effect on the effective
date of this rule); (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 official's 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 official's 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, office of nuclear security 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.
Last updated May 15, 2023 at 4:02 AM
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Rule 3701:1-50-24 | Quality assurance requirements.
Effective:
February 15, 2021
(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 chapter 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 in effect on the effective date of this rule) 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.
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Rule 3701:1-50-26 | Exemption of physicians.
Effective:
February 15, 2021
Any physician licensed by a state 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.
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