Ohio Admin. Code 3701:1-38-23 - Reporting of defects and noncompliance
(A) As used in this rule:
(1) "Basic component" means:
(a) A structure, system, or component, or
part thereof that affects their safety function, that is directly procured by
the licensee or registrant of facility or activity subject to the rules
promulgated pursuant to Chapter 3748. of the Revised Code and in which a defect
or failure to comply with any rule promulgated pursuant to Chapter 3748. of the
Revised Code, order issued by the director, or license issued by the department
could create a substantial safety hazard; and
(b) Safety-related design, analysis,
inspection, testing, fabrication, replacement of parts, or consulting services
that are associated with the component hardware whether these services are
performed by the component supplier or others.
(2) "Commercial grade item" means an item
that is:
(a) Not subject to design or
specification requirements that are unique to those facilities or activities;
(b) Used in applications other
than those facilities or activities; and
(c) To be ordered from the manufacturer or
supplier on the basis of specifications set forth in the manufacturer's
published product description, such as a catalog.
(3) "Constructing" or "construction" means
the analysis, design, manufacture, fabrication, placement, erection,
installation, modification, inspection, or testing of a facility or activity
which is subject to this rule and consulting services related to the facility
or activity that are safety related.
(4) "Dedication" means an item has been
received and designated for use as a basic component.
(5) "Defect" means:
(a) A deviation in a basic component
delivered to a purchaser for use in a facility or an activity subject to this
rule, if, on the basis of an evaluation, the deviation could create a
substantial safety hazard; or
(b)
The installation, use, or operation of a basic component containing a defect as
defined in this paragraph.
(6) "Deviation" means a departure form the
manufacturer's specification's or technical specifications as part of a license
or registration issued by the department for a given safety device or safety
system associated with that device.
(7) "Discovery" means the completion of the
documentation first identifying the existence of a deviation or failure to
comply potentially associated with a substantial safety hazard within the
evaluation procedures discussed in paragraph (G) of this rule.
(8) "Evaluation" means the process of
determining whether a particular deviation could create a substantial hazard or
determining whether a failure to comply is associated with a substantial safety
hazard.
(9) "Failure to comply"
means a failure to meet the requirements of any of the following that could
create a substantial safety hazard:
(a) A
rule promulgated pursuant to Chapter 3748. of the Revised Code;
(b) An order issued by the director; or
(c) License issued by the
department.
(10)
"Operating" or "operation" means the operation of a facility or the conduct of
a licensed or registered activity which is subject to this rule and consulting
services related to operations that are safety related.
(11) "Responsible officer" means:
(a) The president, vice-president or other
individual in the organization of a corporation, partnership, or other entity
who is vested with executive authority over activities subject to this rule, or
(b) An individual who is appointed
or elected according to law, who is authorized to manage and direct the affairs
of a corporation, partnership or other entity. In the case of an individual
proprietorship, responsible officer means the individual.
(12) "Substantial safety hazard" means a loss
of safety function to the extent that there is a major reduction in the degree
of protection provided to either public health and safety or the environment,
for any facility or activity licensed or registered pursuant to Chapter 3748.
of the Revised Code.
(13)
"Supplying" or "supplies" means contractually responsible for a basic component
used or to be used in a facility or activity which is subject to this rule.
(B) This rule
establishes procedures and requirements for implementation of section
3748.04 of the Revised Code,
which applies to reporting of defects in equipment used for licensed or
registered activities. Any responsible corporate officer ofa firm constructing,
owning, operating or supplying the components of any facility or activity which
is licensed, registered, or otherwise regulated pursuant to Chapter 3748. of
the Revised Code, obtaining information reasonably indicating either of the
following, shall notify the director within twenty-four hours:
(1) That the facility, activity or basic
component supplied to such facility or activity fails to comply with any
applicable rule, regulation, order, registration, or license of the department
relating to substantial safety hazards; or
(2) That the facility, activity, or basic
component supplied to such facility or activity contains defects, which could
create a substantial safety hazard.
(C) This rule applies, except as specifically
provided otherwise in Chapter 3748. of the Revised Code, to each individual,
partnership, corporation, or other entity licensed or registered pursuant to
Chapter 3748. of the Revised Code to possess, use, or transfer within the state
of Ohio source material, byproduct
radioactive material, special nuclear material,
or to construct, manufacture, possess, own, operate or transfer within the
state of Ohio any radiation-generating equipment and to each responsible
officer of such a licensee or registrant. This rule applies also to each
individual, corporation, partnership or other entity doing business within the
state of Ohio, that supplies basic components for a facility or activity
licensed, under Chapter 3748. ofthe Revised Code.
(D) Nothing in this rule should be deemed to
preclude either an individual, a manufacturer, or a supplier of a commercial
grade item not subject to this rule from reporting to the director, a known or
suspected defect or failure to comply and, as authorized by law, the identity
of anyone so reporting will be withheld from disclosure. The department will
accept collect telephone calls from individuals who wish to speak to department
representatives concerning radiation safety-related problems.
(E) Each individual, partnership,
corporation, dedicating entity, or other entity subject to this rule shall post
current copies of this rule and procedures adopted pursuant to this rule. These
documents must be posted in a conspicuous position on any premises within the
state of Ohio where the activities subject to this rule are conducted. If
posting of this rule or the procedures adopted pursuant to this rule is not
practicable, the licensee, registrant, or firm subject to this rule may post a
notice which describes the rules and procedures, including the name of the
individual to whom reports may be made, and where the rules and procedures may
be examined.
(F) The director may,
upon application of any interested person or upon the director's own
initiative, grant such exemptions from the requirements of this rule as the
director determines to be authorized by law and will not endanger public health
and safety or the environment, and are otherwise in the public interest.
Suppliers of commercial grade items are exempt from the provisions of this rule
to the extent that they supply commercial grade items.
(G) Each individual, corporation,
partnership, dedicating entity, or other entity subject to this rule shall
adopt appropriate procedures to:
(1) Initiate
evaluations of deviations and failures to comply that are associated with
substantial safety hazards as soon as practicable, but no later than ten days
from the date of discovery of the deviation or failure to comply. The director
shall be notified of any such deviation or failure to comply in accordance with
paragraph (B) of this rule.
(2)
Evaluate a reportable defect or failure to comply that could create a
substantial safety hazard, were it to remain uncorrected, within thirty days of
its discovery, except as provided by paragraph (G)(3) of this rule.
(3) Ensure that if an evaluation of an
identified deviation or failure to comply potentially associated with a
substantial safety hazard cannot be completed within thirty days from discovery
of the deviation or failure to comply, an interim report is prepared and
submitted to the director through a responsible corporate officer. The interim
report should describe the deviation or failure to comply that is being
evaluated and should also state when the evaluation will be completed. This
interim report must be submitted in writing within thirty days of discovery of
the deviation or failure to comply; and
(4) Ensure that a responsible corporate
officer subject to this rule is informed as soon as practicable, and, in all
cases, within five working days after completion of the evaluation described in
this paragraph if the construction or operation of a facility or activity, or a
basic component supplied for such facility or activity either fails to comply
with any applicable rule, regulation, order, or license or registration of the
department relating to a substantial safety hazard, or contains a defect.
(H) If the deviation or
failure to comply is discovered by a supplier of basic components, or services
associated with basic components, and the supplier determines that it does not
have the capability to perform the evaluation to determine if a defect exists,
then the supplier must inform the purchasers or affected licensees or
registrants within five working days of this determination so that the
purchasers or affected licensees or registrants may evaluate the deviation or
failure to comply, pursuant to paragraph (G) of this rule. Nothing in this rule
shall be deemed to require manufacturers or suppliers to adopt or maintain
procedures for defect identification and evaluation, where the item or service
is not dedicated for purposes of licensed or registered activities or
equipment. Instead, such is the responsibility of the registrant or licensee,
in accordance with paragraph (B) of this rule.
(I) A responsible corporate officer subject
to this rule must notify the director within thirty days when he or she obtains
information reasonably indicating a failure to comply or a defect affecting:
(1) The construction or operation of a
facility or any activity within the state of Ohio that is subject to the
licensing or registration requirements under Chapter 3748. of the Revised Code
and that is within the facility's responsibility; or
(2) A basic component that is within the
facility's responsibility and is supplied for a facility or an activity within
the state of Ohio that is subject to the licensing requirements of Chapter
3748. of the Revised Code.
(J) The notification required by paragraphs
(B) and (I) of this rule shall include the following information, to the extent
known:
(1) Name and address of the individual
or individuals informing the director.
(2) Identification of the facility, the
activity, or the basic component supplied for such facility or such activity
within the state of Ohio which fails to comply or contains a defect.
(3) Identification of the firm constructing
the facility or supplying the basic component which fails to comply or contains
a defect.
(4) Nature of the defect
or failure to comply and the safety hazard which is created or could be created
by such defect or failure to comply.
(5) The date on which the information of such
defect or failure to comply was obtained.
(6) In the case of a basic component which
contains a defect or fails to comply, the number and location of all such
components in use at, supplied for, or being supplied for one or more
facilities or activities subject to this rule.
(7) The corrective action which has been, is
being, or will be taken; the name of the individual or organization responsible
for the action; and the length of time that has been or will be taken to
complete the action.
(8) Any
advice related to the defect or failure to comply about the facility, activity,
or basic component that has been, is being, or will be given to purchasers or
licensees.
(K) The
responsible corporate officer may authorize an individual to provide the
notification required by paragraph (J) of this rule, provided that, this shall
not relieve the responsible corporate officer of his or her responsibility
under this paragraph. Individuals subject to this rule may be required by the
director to supply additional information related to a defect or failure to
comply. Department action to obtain additional information may be based on
reports of defects from other reporting entities.
(L) Each individual, corporation,
partnership, or other entity subject to this rule shall prepare and maintain
records necessary to accomplish the requirements of this rule, including
retaining evaluations of all deviations and failures to comply for a minimum of
five years after the date of the evaluation. Each individual, corporation,
partnership, dedicating entity, or other entity subject to this rule shall
permit the department the opportunity to inspect records pertaining to basic
components that relate to the identification and evaluation of deviations, and
the reporting of defects and failures to comply, including any advice given to
purchasers or licensees on the placement, erection, installation, operation,
maintenance, modification, or inspection of a basic component.
(M) Suppliers of basic components must retain
any notifications sent to purchasers and affected licenses for a minimum of
five years after the date of the notification. Suppliers of basic components
must retain a record of the purchasers of basic components for ten years after
delivery of the basic component or service associated with a basic component.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 07/22/2001, 06/20/2003, 10/22/2006, 09/01/2011
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 07/22/2001, 06/20/2003, 10/22/2006, 09/01/2011
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.