[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Notices]
[Pages 49583-49587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21397]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-39071; EA-18-033; NRC-2018-0214]
In the Matter of Harman International Industries, Inc.;
Confirmatory Order
AGENCY: Nuclear Regulatory Commission.
ACTION: Confirmatory order; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
confirmatory order (Order) to Harman International Industries, Inc.
(Harman), to memorialize the agreements reached during an alternative
dispute resolution mediation session held on August 16, 2018. This
Order will resolve the issues that were identified during an NRC
records review related to Harman's import, possession, and distribution
of lamps containing byproduct material (krypton-85). This Order is
effective upon its issuance.
DATES: The confirmatory order became effective on September 27, 2018.
ADDRESSES: Please refer to Docket ID NRC-2018-0214 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly-available information related to this document
using any of the following methods:
Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0214. Address
questions about NRC dockets to Jennifer Borges; telephone: 301-287-
9127; e-mail: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or
by e-mail to [email protected]. The ADAMS accession number for each
document referenced (if it is available in ADAMS) is provided the first
time that it is mentioned in this document.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Sophie Holiday, Office of Enforcement,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-001;
telephone: 301-415-7865, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The text of the Order is attached.
Dated at Rockville, Maryland, this 27th day of September 2018.
For the Nuclear Regulatory Commission.
Anne T. Boland,
Director, Office of Enforcement.
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
In the Matter of: Harman International Industries, Inc.,
Northridge, California
[[Page 49584]]
Docket No. 030-39071
License No. 04-35446-01E
EA-18-033
CONFIRMATORY ORDER MODIFYING LICENSE (EFFECTIVE UPON ISSUANCE)
I
Harman International Industries, Incorporated, (Harman or Licensee)
is the holder of Materials License No. 04-35446-01E issued on December
15, 2017, by the U.S. Nuclear Regulatory Commission (NRC) pursuant to
Part 30 of Title 10 of the Code of Federal Regulations (10 CFR), Rules
of General Applicability to Domestic Licensing of Byproduct Material.
The license authorizes Harman to distribute lamps containing byproduct
material (krypton-85) to persons exempt from the regulations. Harman
was located in Elkhart, Indiana (IN), prior to June 2018, and is
currently located in Northridge, California (CA), with a distribution
facility located in Moreno Valley, CA.
This Confirmatory Order is the result of an agreement reached
during an Alternative Dispute Resolution (ADR) mediation session
conducted on August 16, 2018.
II
The NRC conducted a review on October 2016 through February 2018,
related to the import, possession, and distribution of licensed
materials (lamps containing krypton-85) by Harman in areas of NRC
jurisdiction without having the required NRC licenses.
On June 7, 2018, the NRC issued a letter to Harman that identified
the results of the records review and outlined three apparent
violations. The apparent violations involved:
(1) initially transferring, for sale or distribution, lamps
containing krypton-85 without an NRC license for such activity pursuant
to 10 CFR Sections 30.3(a), 30.15(a)(8)(iv), and 32.14; (2) possession
of material (krypton-85) without an NRC license for such activity
pursuant to 10 CFR 30.3; and (3) importing material (krypton-85) into
the United States (U.S.) without an NRC or Agreement State license for
possession of the material containing byproduct material pursuant to 10
CFR 110.5, 110.9a, 110.20(a), and 110.27(a).
In the June 7, 2018, letter, the NRC offered Harman the choice to:
(1) attend a Pre[dash]decisional Enforcement Conference (PEC); or (2)
participate in an ADR mediation session in an effort to resolve these
concerns.
In response to the NRC's letter, Harman requested ADR. On August
16, 2018, Harman and the NRC met in an ADR session mediated by a
professional mediator, arranged through Cornell University's Institute
on Conflict Resolution. The ADR process is one in which a neutral
mediator, with no decision-making authority, assists the parties in
reaching an agreement on resolving any differences regarding the
dispute. This Confirmatory Order is issued pursuant to the agreement
reached during the ADR process.
III
During the ADR session, Harman and the NRC reached a preliminary
settlement agreement. The elements of the agreement included Harman
acceptance of the violations for a period of non-compliance from
approximately March 2016 to February 2017, corrective actions that
Harman stated were completed as described below, agreed upon future
actions, and general provisions as follows:
Harman Completed Corrective Actions to Restore Compliance:
1. As of mid-February 2017, Harman stopped the shipment into the
U.S. of finished products containing krypton-85 lamps and krypton-85
spare bulbs.
2. As of mid-February 2017, Harman stopped the shipment to dealers,
end users, etc. in the U.S. of Harman's finished products containing
krypton-85 lamps and krypton-85 spare bulbs.
3. As of April 2017, the licensee quarantined all remaining product
in the Quality Assurance cage (QA cage) to further ensure no product
would be distributed (which requires the Quality Manager signature to
release).
4. As of May 18, 2017, no radioactive material remained at the
Elkhart, IN, location, and all remaining imported bulbs in Elkhart were
shipped back to the manufacturer.
5. On June 29, 2017, Harman submitted an application to the State
of California, and on December 15, 2017, received a California license
for possession of krypton-85 at Harman's facility located in Moreno
Valley, CA.
6. Harman submitted an application for a distribution license in
September 2017, and on December 15, 2017, NRC issued to Harman
distribution license No. 04[dash]35446-01E.
7. Harman engaged the services of a consultant to assist with the
NRC license application.
8. Harman has established the position of Compliance Manager. This
role is in addition to the Radiation Safety Officer (RSO) for the
license. The Compliance Manager is responsible for ensuring compliance
with NRC requirements.
9. Harman has established the New Product Introduction/Product
Lifecycle Management (NPI/PLM) process.
a. The NPI/PLM is a multistep process that includes determination
of whether NRC requirements apply, and ensures compliance with NRC
requirements.
b. All new or changed products (to overall or component design),
new or changed processes, or transfers of product undergo the process.
c. When radioactive material is identified, the Compliance Manager
and the RSO must approve that the process/component changes are
consistent with NRC requirements.
Harman Future Actions to Enhance Compliance:
1. Harman will maintain the position of Compliance Manager. This
role is in addition to the RSO for the license. The Compliance Manager
is responsible for ensuring compliance with NRC requirements.
2. Harman will maintain the NPI/PLM process as described above.
3. Within 90 days of the date of this Confirmatory Order, Harman
will ensure that:
a. The documented NPI/PLM process prompts the identification and
application of NRC requirements (including regulatory, license, and
Order).
b. Applicable documents define the roles and responsibilities of
the Compliance Manager and RSO, in the NPI/PLM process, as they relate
to NRC requirements.
4. Within 90 days of the date of this Confirmatory Order, Harman
will issue a letter from the Compliance Manager to the President, Vice
Presidents, and the Directors who report to the Vice President for
Operations and Procurement, to ensure awareness of the violations and
actions taken. The letter will include:
a. A description of the violations, including a copy of the NRC
letter dated June 7, 2018.
b. The actions taken to restore compliance, including a copy of
this Confirmatory Order.
5. Within 90 days of the date of this Confirmatory Order, Harman
will issue a communication to foreign suppliers of lighting products to
Harman to promote awareness of the NRC requirements.
a. The communication will include:
i. That there are U.S. requirements for products containing
radioactive material that will be imported and distributed within the
U.S.
ii. That selling product to customers could result in putting those
entities in non-compliance with U.S. requirements.
iii. Contact information for the NRC.
[[Page 49585]]
iv. A request to pass the communication to the suppliers'
affiliates and potentially impacted customers.
b. Harman will provide a copy of the letter to NRC, 30 days in
advance of issuance.
6. Harman will conduct training for the participants in the NPI/PLM
process.
a. Harman will review and modify, if not already included, the
current Compliance Training to ensure that it contains the following:
i. NRC regulatory framework.
ii. Applicable requirements for the activities being conducted.
iii. The role of each NPI/PLM participant in ensuring compliance
and the specific role of the Compliance Manager and RSO.
b. The training will include an initial training and annual
periodic training.
c. The initial training will be completed within 180 days of the
date of this Confirmatory Order.
d. Harman will maintain documentation of individuals trained.
7. Harman will continue to conduct training for all employees
handling radioactive material.
a. Content will include radiation safety and NRC requirements.
b. The training will include an initial training and annual
periodic training.
c. The next training will be completed within 90 days of the date
of this Confirmatory Order.
d. Harman will maintain documentation of individuals trained.
8. Beginning in calendar year 2020, Harman will perform an annual
audit to ensure compliance with NRC requirements. The audit will be
completed in the first quarter of each calendar year.
9. By March 31, 2019:
a. Harman will conduct an audit using an independent third-party
consultant to evaluate compliance with NRC requirements.
b. The audit will not commence prior to December 31, 2018.
c. The audit will:
i. Include review of compliance with NRC requirements.
ii. Be documented by an audit report, including the scope,
observations, and findings.
d. Harman will provide to the NRC a copy of the consultant report,
and a description of any corrective actions taken as a result of the
audit.
General provisions:
1. For the purposes of this agreement, the term ``requirements''
includes NRC rules, license and Order requirements.
2. Unless otherwise specified, all dates are calendar days from the
date of issuance of this Confirmatory Order.
3. Unless otherwise specified, all documents required to be
submitted to the NRC will be sent to: Director, Division of Materials
Safety, Security, State and Tribal Programs, Office of Nuclear Material
Safety and Safeguards, Two White Flint North, 11545 Rockville Pike,
Rockville, MD 20852-2738, with copies to the Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,
11555 Rockville Pike, Rockville, MD 20852-2738, and to the Branch
Chief, Materials Safety Licensing Branch, Division of Materials Safety,
Security, State and Tribal Programs, Office of Nuclear Material Safety
and Safeguards, Two White Flint North, 11545 Rockville Pike, Rockville,
MD 20852-2738. Harman will also endeavor to provide courtesy electronic
copies to the above individuals, at their NRC email addresses.
4. NRC agrees not to issue a separate Notice of Violation.
5. NRC will categorize the violations as one Severity Level III
problem, with a civil penalty of half the base in the amount of $7,250.
6. The Confirmatory Order will be considered escalated action
consistent with the current NRC Enforcement Policy for future
enforcement.
7. In the event of the transfer of the possession and/or
distribution licenses of Harman to another entity, the terms and
conditions set forth hereunder shall continue to apply to the new
entity and accordingly survive any transfer of ownership or license.
8. Based on the completed actions described above, and the
commitments described in Section V below, the NRC agrees to not pursue
any further enforcement action based on the apparent violations
identified in the NRC's June 7, 2018, letter.
On September 21, 2018, Harman consented to issuing this
Confirmatory Order with the commitments, as described in Section V
below. Harman further agreed that this Confirmatory Order is to be
effective upon issuance, the agreement memorialized in this
Confirmatory Order settles the matter between the parties, and that it
has waived its right to a hearing.
IV
I find that the Harman actions completed, as described in Section
III above, combined with the commitments as set forth in Section V, are
acceptable and necessary, and conclude that with these commitments the
public health and safety are reasonably assured. In view of the
foregoing, I have determined that public health and safety require that
Harman's commitments be confirmed by this Confirmatory Order. Based on
the above and Harman's consent, this Confirmatory Order is effective
upon issuance.
V
Accordingly, pursuant to Sections 81, 161(b), 161(i), 161(o), 182,
and 186 of the Atomic Energy Act of 1954, as amended, and the
Commission's regulations in 10 CFR 2.202 and 10 CFR part 30, IT IS
HEREBY ORDERED, EFFECTIVE UPON ISSUANCE, THAT LICENSE NO.
04[dash]35446[dash]01E IS MODIFIED AS FOLLOWS:
1. Harman will maintain the position of Compliance Manager. This
role is in addition to the Radiation Safety Officer (RSO) for the
license. The Compliance Manager is responsible for ensuring compliance
with NRC requirements.
2. Harman will maintain the New Product Introduction/Product
Lifecycle Management (NPI/PLM) process as described in Section III
above.
3. Within 90 days of the date of this Confirmatory Order, Harman
will ensure that:
a. The documented NPI/PLM process prompts the identification and
application of NRC requirements (including regulatory, license, and
Order).
b. Applicable documents define the roles and responsibilities of
the Compliance Manager and RSO, in the NPI/PLM process, as they relate
to NRC requirements.
4. Within 90 days of the date of this Confirmatory Order, Harman
will issue a letter from the Compliance Manager to the President, Vice
Presidents, and the Directors who report to the Vice President for
Operations and Procurement, to ensure awareness of the violations and
actions taken. The letter will include:
a. A description of the violations, including a copy of the NRC
letter dated June 7, 2018.
b. The actions taken to restore compliance, including a copy of
this Confirmatory Order.
5. Within 90 days of the date of this Confirmatory Order, Harman
will issue a communication to foreign suppliers of lighting products to
Harman to promote awareness of the NRC requirements.
a. The communication will include:
i. That there are U.S. requirements for products containing
radioactive material that will be imported and distributed within the
U.S.
ii. That selling product to customers could result in putting those
entities in non-compliance with U.S. requirements.
[[Page 49586]]
iii. Contact information for the NRC.
iv. A request to pass the communication to the suppliers'
affiliates and potentially impacted customers.
b. Harman will provide a copy of the letter to NRC, 30 days in
advance of issuance.
6. Harman will conduct training for the participants in the NPI/PLM
process.
a. Harman will review and modify, if not already included, the
current Compliance Training to ensure that it contains the following:
i. NRC regulatory framework.
ii. Applicable requirements for the activities being conducted.
iii. The role of each NPI/PLM participant in ensuring compliance
and the specific role of the Compliance Manager and RSO.
b. The training will include an initial training and annual
periodic training.
c. The initial training will be completed within 180 days of the
date of this Confirmatory Order.
d. Harman will maintain documentation of individuals trained.
7. Harman will continue to conduct training for all employees
handling radioactive material.
a. Content will include radiation safety and NRC requirements.
b. The training will include an initial training and annual
periodic training.
c. The next training will be completed within 90 days of the date
of this Confirmatory Order.
d. Harman will maintain documentation of individuals trained.
8. Beginning in calendar year 2020, Harman will perform an annual
audit to ensure compliance with NRC requirements. The audit will be
completed in the first quarter of each calendar year.
9. By March 31, 2019:
a. Harman will conduct an audit using an independent third-party
consultant to evaluate compliance with NRC requirements.
b. The audit will not commence prior to December 31, 2018.
c. The audit will:
i. Include review of compliance with NRC requirements.
ii. Be documented by an audit report, including the scope,
observations, and findings.
d. Harman will provide to NRC a copy of the consultant report, and
a description of any corrective actions taken as a result of the audit.
10. Harman will pay a civil penalty in the amount of $7,250.
For the purposes of this agreement, the term ``requirements''
includes NRC rules, license and Order requirements.
Unless otherwise specified, all dates are calendar days from the
date of issuance of the Confirmatory Order.
Unless otherwise specified, all documents required to be submitted
to the NRC will be sent to: Director, Division of Materials Safety,
Security, State and Tribal Programs, Office of Nuclear Material Safety
and Safeguards, Two White Flint North, 11545 Rockville Pike, Rockville,
MD 20852-2738, with copies to the Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, One White Flint North, 11555 Rockville
Pike, Rockville, MD 20852-2738, and to the Branch Chief, Materials
Safety Licensing Branch, Division of Materials Safety, Security, State
and Tribal Programs, Office of Nuclear Material Safety and Safeguards,
Two White Flint North, 11545 Rockville Pike, Rockville, MD 20852-2738.
Harman will also endeavor to provide courtesy electronic copies to the
above individuals, at their NRC email addresses.
The Confirmatory Order will be considered escalated action
consistent with NRC current Enforcement Policy for future enforcement.
In the event of the transfer of the possession and/or distribution
licenses of Harman to another entity, the terms and conditions set
forth hereunder shall continue to apply to the new entity and
accordingly survive any transfer of ownership or license.
The Director, Office of Enforcement, NRC, may, in writing, relax or
rescind any of the above conditions upon written request by Harman, and
demonstration by Harman or its successors of good cause.
VI
In accordance with 10 CFR 2.202 and 10 CFR 2.309, any person
adversely affected by this Confirmatory Order, other than Harman, may
request a hearing within thirty (30) calendar days of the date of
issuance of this Confirmatory Order. Where good cause is shown,
consideration will be given to extending the time to request a hearing.
A request for extension of time must be made in writing to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, and include a statement of good cause for the
extension.
All documents filed in NRC adjudicatory proceedings, including a
request for hearing, a petition for leave to intervene, any motion or
other document filed in the proceeding prior to the submission of a
request for hearing or petition to intervene (hereinafter
``petition''), and documents filed by interested governmental entities
participating under 10 CFR 2.315(c), must be filed in accordance with
the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended by 77
FR 46562, August 3, 2012). The E-Filing process requires participants
to submit and serve all adjudicatory documents over the internet, or in
some cases to mail copies on electronic storage media. Participants may
not submit paper copies of their filings unless they seek an exemption
in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least
ten (10) calendar days prior to the filing deadline, the participant
should contact the Office of the Secretary by e-mail at
[email protected], or by telephone at 301-415-1677, to (1) request
a digital identification (ID) certificate, which allows the participant
(or its counsel or representative) to digitally sign submissions and
access the E-Filing system for any proceeding in which it is
participating; and (2) advise the Secretary that the participant will
be submitting a petition or other adjudicatory document (even in
instances in which the participant, or its counsel or representative,
already holds an NRC-issued digital ID certificate). Based upon this
information, the Secretary will establish an electronic docket for the
hearing in this proceeding if the Secretary has not already established
an electronic docket.
Information about applying for a digital ID certificate is
available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a
digital ID certificate and a docket has been created, the participant
can then submit adjudicatory documents. Submissions must be in Portable
Document Format (PDF). Additional guidance on PDF submissions is
available on the NRC's public Web site at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the
time the document is submitted through the NRC's E[dash]Filing system.
To be timely, an electronic filing must be submitted to the E-Filing
system no later than 11:59 p.m. Eastern Time on the due date. Upon
receipt of a transmission, the E[dash]Filing system time-stamps the
document and sends the submitter an e-mail notice confirming receipt of
the document. The E-Filing system also distributes an e-mail notice
that provides access to the document to the NRC's Office of the General
Counsel and any others who have advised the Office of the Secretary
that they wish to participate in the proceeding, so that the filer need
not serve the document on
[[Page 49587]]
those participants separately. Therefore, applicants and other
participants (or their counsel or representative) must apply for and
receive a digital ID certificate before adjudicatory documents are
filed so that they can obtain access to the documents via the E-Filing
system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic
Filing Help Desk through the ``Contact Us'' link located on the NRC's
Public Web site at http://www.nrc.gov/site-help/e-submittals.html, by
e-mail to [email protected], or by a toll-free call at 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9 a.m.
and 6 p.m., Eastern Time, Monday through Friday, excluding government
holidays.
Participants who believe that they have good cause for not
submitting documents electronically must file an exemption request, in
accordance with 10 CFR 2.302(g), with their initial paper filing
stating why there is good cause for not filing electronically and
requesting authorization to continue to submit documents in paper
format. Such filings must be submitted by: (1) first class mail
addressed to the Office of the Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention:
Rulemaking and Adjudications Staff; or (2) courier, express mail, or
expedited delivery service to the Office of the Secretary, 11555
Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and
Adjudications Staff. Participants filing adjudicatory documents in this
manner are responsible for serving the document on all other
participants. Filing is considered complete by first-class mail as of
the time of deposit in the mail, or by courier, express mail, or
expedited delivery service upon depositing the document with the
provider of the service. A presiding officer, having granted an
exemption request from using E-Filing, may require a participant or
party to use E-Filing if the presiding officer subsequently determines
that the reason for granting the exemption from use of E-Filing no
longer exists.
Documents submitted in adjudicatory proceedings will appear in the
NRC's electronic hearing docket which is available to the public at
https://adams.nrc.gov/ehd, unless excluded pursuant to an Order of the
Commission or the presiding officer. If you do not have an NRC-issued
digital ID certificate as described above, click ``Cancel'' when the
link requests certificates and you will be automatically directed to
the NRC's electronic hearing dockets where you will be able to access
any publicly available documents in a particular hearing docket.
Participants are requested not to include personal privacy information,
such as social security numbers, home addresses, or personal phone
numbers in their filings, unless an NRC regulation or other law
requires submission of such information. For example, in some
instances, individuals provide home addresses in order to demonstrate
proximity to a facility or site. With respect to copyrighted works,
except for limited excerpts that serve the purpose of the adjudicatory
filings and would constitute a Fair Use application, participants are
requested not to include copyrighted materials in their submission.
The Commission will issue a notice or order granting or denying a
hearing request or intervention petition, designating the issues for
any hearing that will be held and designating the Presiding Officer. A
notice granting a hearing will be published in the Federal Register and
served on the parties to the hearing.
If a person (other than Harman) requests a hearing, that person
shall set forth with particularity the manner in which his interest is
adversely affected by this Confirmatory Order and shall address the
criteria set forth in 10 CFR 2.309(d) and (f).
If a hearing is requested by a person whose interest is adversely
affected, the Commission will issue an Order designating the time and
place of any hearings. If a hearing is held, the issue to be considered
at such hearing shall be whether this Confirmatory Order should be
sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), any person adversely affected by
this Order, may, in addition to demanding a hearing, at the time the
answer is filed or sooner, move the presiding officer to set aside the
immediate effectiveness of the Order on the ground that the Order,
including the need for immediate effectiveness, is not based on
adequate evidence but on mere suspicion, unfounded allegations, or
error. In the absence of any request for hearing, or written approval
of an extension of time in which to request a hearing, the provisions
specified in Section V above shall be final thirty (30) calendar days
from the date of issuance of this Confirmatory Order without further
order or proceedings. If an extension of time for requesting a hearing
has been approved, the provisions specified in Section V shall be final
when the extension expires if a hearing request has not been received.
A request for hearing shall not stay the effectiveness of this
order.
For the Nuclear Regulatory Commission,
Anne T. Boland,
Director, Office of Enforcement.
Dated this 27th day of September 2018.
cc: The State of California
[FR Doc. 2018-21397 Filed 10-1-18; 8:45 am]
BILLING CODE 7590-01-P