also demonstrate that the product is designed and manufactured in accordance with the safety
criteria in 10 CFR 32.23. Paragraph 32.22(b) further indicates that the Commission may deny
an application for a specific license if the end uses of the product cannot be reasonably
foreseen.

Section 30.15 provides a list of product-specific exemptions for certain products
containing byproduct material, subject to certain limits including specific radionuclide quantity
limits. The receipt, possession, use, transfer, ownership, and acquisition of these products,
which includes self-luminous timepieces, hands, and dials, are exempt from licensing
requirements. Persons wishing to apply or incorporate byproduct material into these products
or initially transfer them for sale or distribution must apply for a specific license under 10 CFR
32.14. Unlike products covered by the 10 CFR 30.19 class exemption, specific products listed
in 10 CFR 30.15 do not need to be registered under 10 CFR 32.210 in order for one to obtain a
specific license for distribution.

NRC’s Consumer Product Policy Statement (CPPS or policy) (January 16, 2014;

79 FR 2907) provides the Commission's policy with respect to approval of the use of byproduct,
source, and special nuclear material in products intended for use by the general public
(consumer products) without the imposition of regulatory controls on the consumer-user. The

revision of the consumer product policy statement was finalized after the petition was filed.

Petitioner's Requests

Request 1
The petitioner requests that the NRC amend 10 CFR 32.22(b) to include a statement

that an applicant cannot be denied a device registration or distribution license if they-have-it has

adequately demonstrated that the criteria in the applicable regulations have been met.


[7590-01-P]

NUCLEAR REGULATORY COMMISSION
10 CFR Part 32
[Docket No. PRM-32-8; NRC-2013-0078]

Commercial Distribution of Tritium Markers

AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Petition for rulemaking; denial.

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is denying a petition for
rulemaking (PRM), dated December 2, 2011, which was filed with the NRC by CampCo (the
petitioner) and supplemented with additional information on September 18, 2012. The petitioner
requests the NRC to amend its regulations that govern the licensing of products containing
byproduct material to allow the commercial distribution of tritium markers for use under an
exemption from licensing requirements. The NRC is denying the petition because the petitioner
fails to demonstrate that a specific exemption is warranted and that the existing regulatory

framework for self-luminous products is insufficient.

DATES: The docket for the petition for rulemaking, PRM-32-8, is closed on [INSERT DATE

OF PUBLICATION IN THE FEDERAL REGISTER).


The petitioner stated that the tritium markers are sold in other countries. The discussion
in the CPPS recognizes that it is unavoidable that there will be some differences made in
judgments concerning justification of practice. Generally, international standards, such as the
International Atomic Energy Agency's “Radiation Protection and Safety of Radiation Sources:
International Basic Safety Standards,” weuld net suggest that this product should not be

exempted:. Hhowever, individual countries’ regulatory bodies make their own judgments.

IV. Reasons for Denial.

The NRC is denying the petition because the petitioner fails to demonstrate that a
specific exemption is warranted andor that the existing regulatory framework for self-luminous
products is inappropriate. The tritium markers do not meet the regulatory frarrework-criteriafor
the use of self-luminous products under an exemption from licensing. In addition, the
self-luminous product class exemption was set up to eliminate the need to evaluate numerous
PRMs for a wide variety of self-luminous products and the need to conduct a separate
rulemaking to add individual exemptions for each acceptable one. Fhe NRG-confirmsthat Tthis

provision is needed to ensure that the use of radioactive material in a product is justified.

14


or promethium-147”; and 10 CFR 30.15, “Certain items containing byproduct material.” The
petitioner also provided a dose assessment for the purpose of showing that the tritium markers
would result in acceptably low doses.

The petitioner requests that the NRC amend 10 CFR 32.22(b) to include an additional
requirement stating that an applicant cannot be denied a device registration or distribution
license if they-haveit has adequately demonstrated that the criteria in applicable regulations
have been met. The petitioner contends that the statement in 10 CFR 32.22(b), that “the
Commission may deny an application for a specific license if the end uses of the product cannot
be reasonably foreseen,” is a subjective statement without specific criteria and that it is unfair to
deny applications based upon subjective statements where the criteria are not codified in the
regulations. The petitioner references a Memorandum on Scientific Integrity issued by
President Obama on March 9, 2009, which states that “[s]cience and the scientific process must
inform and guide decisions of [the] Administration on a wide range of issues, including
improvement of public health.” The petitioner notes that the NRC has previously denied
approval of products because end uses of the products could not reasonably be foreseen. The
petitioner also states that the term “frivolous use,” as used in the NRC's policy statement on
consumer products (March 16, 1965, 30 FR 3462; proposed revision October 14, 2011, 76 FR
63957) and in the NRC’s guidance for materials licenses (NUREG-1556, Volume 3, Revision 1,
“Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device
Evaluation and Registration),” (ADAMS Accession No. ML041340618) is not clearly defined and
that there are no detailed criteria used to make determinations. The petitioner asserts that the
potential misuse of a tritium marker as a toy should not result in the product being banned

outright.


Response to Petitioner’s Request 1

Paragraph 32.22(b) allows the NRC to exercise its judgment in denying a license
application when the end use of a product cannot be reasonably foreseen. The requested
amendment would affect all future applications for a license under this section and would reveke
limit the NRC’s ability to deny an applicant based on whether a practice (in this case, the
distribution of certain products for use by the general public) is justified. Being able to project
the likely uses of a product also impacts the ability to fully assess potential exposures of people
to radiation and to determine acceptable prototype testing to reflect the conditions of use. #

granted,this revision would + strict the NRC's-authority—Furthermore, this suggested revision

would make 10 CFR 32.22(b) internally inconsistent and essentially would nullify it.

Such a revision would be inconsistent with the NRC’s Consumer Product Policy
Statement, revised in January 2014. In response to a public comment that discussed the issue
of -being-able-ability to foresee the end uses of products, the Commission explicitly stated the
importance of evaluating products “on a case-by-case basis,” listing a number of considerations
such as likely doses, the probability and severity of accidents and misuse, and the benefits to be
obtained from the product, noting that these cannot be reasonably evaluated if the ultimate uses
of the product are not known (79 FR 2910). The Commission addressed the importance of this
particular regulatory criterion that allows the denial of a distribution license for a product whose
end uses cannot be reasonably foreseen, stating “[sJelf-luminous products in particular have a
wide range of potential applications and might easily be widely used for purposes other than
those originally intended if not clearly designed for a specific use. This criterion also ensures:
that the uses. . . of radioactive material in products are justified.” /d. Therefore, it is important
for the NRC is-reserving-the-right-to be able to exercise its judgment in denying a license

application when the end use of a product cannot be reasonably foreseen.


of byproduct material including tritium, or marine compasses containing tritium, are designed for
specific uses. As previously indicated, the Commission has stated that “[s]elf-luminous products
in particular have a wide range of potential applications and might easily be widely used for
purposes other than those originally intended if not clearly designed for a specific use”

(79 FR 2910). Based on the small size (1.8 cm long by 0.8 cm diameter by 0.2 cm thick) and
the design of the tritium markers, the tritium markers have potential uses beyond those intended
by the petitioner, including as decorations on zipper pulls on clothing or as jewelry. The lack of
a clear design for a specific use creates greater potential for unintended uses (such as the ones

specifically excluded from the exemption in 10 CFR 30.19), which outweighs the product's

beneficial uses. Because-of the-potential for widespread _use,careful con ideration-of

justification of practice is important

Also, the size and glow-in-the-dark nature of the tritium markers would appeal to and be
accessible to children. Creating a new specific exemption for these tritium markers would be
inconsistent with the CPPS, in particular, paragraph four (79 FR 2912), which requires that
products subject to mishandling, especially by children, require an unusual degree of safety and
utility. This criterion is unchanged from the original 1965 version of the policy. The tritium
markers do not meet this criterion as they do not provide an unusual degree of utility. The
unique benefits as compared to other alternatives are considered relatively limited. For
example, the uses of the tritium markers asserted by the petitioner can be achieved by other
products on the market, such as battery-powered products. While the use of tritium presents a
particular benefit by staying illuminated continuously without having to be turned on when
needed, the amount of light created using the 25 mCi of tritium suggested for the new

exemption is fairly-limited. Also, self-luminous products containing tritium light sources

incorporated into products with clear end uses can provide some of the same benefits.

10


The petitioner requests that the NRC also amend 10 CFR 30.19(c) to add that tritium
markers used to label equipment are not considered to be toys or adornments and shall not be
sold as such.

The petitioner also requests that the NRC amend 10 CFR 30.15 to add a specific
exemption for tritium markers with a maximum activity of 25 millicuries (925 mBq) of tritium.
The petitioner believes an exemption is warranted because of the usefulness of the tritium
markers and the low dose potential. The petitioner states that the markers would not be a
frivolous use of radioactive material, and that “the potential radiation doses to members of the
public under normal use and accident conditions...are within regulatory limits.” The petitioner
also states that the markers are sold in other countries and have practical benefit such as
helping military personnel recover lost items, helping first responders locate tagged equipment

at night, assisting hunters in finding lost items, and helping lost campers find their tents.

ll. Public Comments on the Petition.

The notice of receipt published in the Federal Register (July 11, 2013; 78 FR 41720),
invited interested persons to submit comments. The comment period closed on
September 24, 2013. The NRC received one public comment opposing the petition. The
commenter states:

“An interest in record keeping in the known supply of tritium should be

recognized since tritium may, in some cases, be the only useful tracer for a

smuggled weapon. An unrecorded presence of legitimately obtained tritium may

lead to too many false positives during a crisis.”


NOTATION VOTE

RESPONSE SHEET
10: Annette Vietti-Cook, Secretary
FROM: COMMISSIONER SVINICKI
SUBJECT: SECY-15-0056: Denial of Petition for Rulemaking
(PRM-32-8)
Approved XX__ Disapproved Abstain

Not Participating

COMMENTS: Below XX Attached XX None

| approve denial of the petition for rulemaking and publication of the Federal Register notice
announcing the denial, subject to the edits provided by Chairman Burns in his vote and the
attached, additional edit.

SKGNATURE

os 5
DATE
Entered in STARS” Yes f/f No



also demonstrate that the product is designed and manufactured in accordance with the safety
criteria in 10 CFR 32.23. Paragraph 32.22(b) further indicates that the Commission may deny
an application for a specific license if the end uses of the product cannot be reasonably
foreseen.

Section 30.15 provides a list of product-specific exemptions for certain products
containing byproduct material, subject to certain limits including specific radionuclide quantity
limits. The receipt, possession, use, transfer, ownership, and acquisition of these products,
which includes self-luminous timepieces, hands, and dials, are exempt from licensing
requirements. Persons wishing to apply or incorporate byproduct material into these products
or initially transfer them for sale or distribution must apply for a specific license under 10 CFR
32.14. Unlike products covered by the 10 CFR 30.19 class exemption, specific products listed
in 10 CFR 30.15 do not need to be registered under 10 CFR 32.210 in order for one to obtain a
specific license for distribution.

NRC's Consumer Product Policy Statement (CPPS or policy) (January 16, 2014;

79 FR 2907) provides the Commission's policy with respect to approval of the use of byproduct,
source, and special nuclear material in products intended for use by the general public
(consumer products) without the imposition of regulatory controls on the consumer-user. The

revision of the consumer product policy statement was finalized after the petition was filed.

Petitioner’s Requests

Request 1

The petitioner requests that the NRC amend 10 CFR 32.22(b) to include a statement
that an applicant cannot be denied a device registration or distribution license if they-haveit has

adequately demonstrated that the criteria in the applicable regulations have been met.


Although the NRC is denying the petition, the NRC disagrees with the commenter that
the presence of tritium in approved consumer products would negatively affect law enforcement

efforts to track illegal weapons.

Ill. Discussion.

The NRC regulates consumer products containing byproduct material without imposing
regulatory controls on the consumer—user. Those who manufacture or distribute products
containing byproduct material, including consumer products, must have a license issued under
10 CFR part 32. Exemptions for users of products containing byproduct material appear in
10 CFR part 30. These exemptions are either product-specific or class exemptions.

A class exemption covers a class of products, for which a person who wishes to
manufacture or distribute a specific product within that class may submit a license application.
An applicant must provide safety information about the product and demonstrate that the
product meets a number of safety criteria. Exemption of a product under a class exemption is
dependent on approval under the applicable regulations for the distributor.

Section 30.19 is a class exemption for the receipt, possession, use, transfer, ownership,
or acquisition of self-luminous products containing certain radionuclides, including tritium. This
exemption does not apply to persons who manufacture, process, produce, or initially transfer
such products for sale or distribution. Paragraph (c) in 10 CFR 30.19 states that the exemption
for products containing tritium, krypton—85, or promethium—147 does not apply to products
primarily for frivolous purposes or in toys or adornments. Those who wish to initially transfer for
sale or distribute distribution self-luminous products covered by the 10 CFR 30.19 class
exemption must first apply for and receive a specific license under 10 CFR 32.22 and must have

the product registered under 10 CFR 32.210. Applicants for licenses under 10 CFR 32.22 must

6


Although the NRC is denying the petition, the NRC disagrees with the commenter that
the presence of tritium in approved consumer products would negatively affect law enforcement

efforts to track illegal weapons.

Ill. Discussion.

The NRC regulates consumer products containing byproduct material without imposing
regulatory controls on the consumer—user. Those who manufacture or distribute products
containing byproduct material, including consumer products, must have a license issued under
10 CFR part 32. Exemptions for users of products containing byproduct material appear in
140 CFR part 30. These exemptions are either product-specific or class exemptions.

A class exemption covers a class of products, for which a person who wishes to
manufacture or distribute a specific product within that class may submit a license application.
An applicant must provide safety information about the product and demonstrate that the
product meets a number of safety criteria. Exemption of a product under a class exemption is
dependent on approval under the applicable regulations for the distributor.

Section 30.19 is a class exemption for the receipt, possession, use, transfer, ownership,
or acquisition of self-luminous products containing certain radionuclides, including tritium. This
exemption does not apply to persons who manufacture, process, produce, or initially transfer
such products for sale or distribution. Paragraph (c) in 10 CFR 30.19 states that the exemption
for products containing tritium, krypton—85, or promethium—147 does not apply to products
primarily for frivolous purposes or in toys or adornments. Those who wish to initially transfer for
sale or distribute-distribution self-luminous products covered by the 10 CFR 30.19 class
exemption must first apply for and receive a specific license under 10 CFR 32.22 and must have

the product registered under 10 CFR 32.210. Applicants for licenses under 10 CFR 32.22 must

6


Request 2
The petitioner requests that the NRC amend 10 CFR 30.19(c) to add that tritium markers

used to label equipment are not considered to be toys or adornments and shall not be sold as

such.

Response to Petitioner’s Request 2

Paraaraph 30-19(c) already-states_thatth: maption-di not te if
grap: mbes Bs iP ¥

adornments—The requested amendment stating that the tritium markers “shall not be sold” as
toys or adornments would not further control whether these products can be distributed as such.
Additionally, there is no need to expressly designate products that are or are not “toys or
adornments” for purposes of 10 CFR 30.19(c) because NRC staff can apply the normal
dictionary definition of such terms to individual products on a case-by-case basis.

Paragraph 30.19(c) also addresses self-luminous products generally, which makes references
to specific products inappropriate. Most importantly, including a reference to tritium markers
used for labeling purposes would prejudge the product as covered by the exemption, contrary to
the intent of the regulatory framework and the CPPS, which stresses the importance of

case-by-case determinations.

Request 3

The petitioner requests that the NRC amend 10 CFR 30.15 to add a specific exemption

for tritium markers with a maximum activity of 25 millicuries (925 mBq) of tritium.

Response to Petitioner’s Request 3
The NRC is choosing to not include a new specific exemption for these tritium markers
at this time, consistent with the guiding principles within the CPPS. The exempt products in

10 CFR 30.15, such as timepieces or hands or dials containing specified quantities of byproduct
9


V. Conclusion.

For the reasons cited in this document, the NRC is denying PRM-32-8. The petition

fails to present any significant new information or arguments that would warrant the requested

amendments.

Dated at Rockville, Maryland, this day of 2015:

For the U.S. Nuclear Regulatory Commission.

Annette L. Vietti-Cook,
Secretary of the Commission.

12


UNITED STATES

NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 20555-0001

June 17, 2015

SECRETARY COMMISSION VOTING RECORD

DECISION ITEM: SECY-15-0056

TITLE: DENIAL OF PETITION FOR RULEMAKING (PRM-32-8)
The Commission (with all Commissioners agreeing) approved the subject paper as recorded in
the Staff Requirements Memorandum (SRM) of June 17, 2015.

This Record contains a summary of voting on this matter together with the individual vote
sheets, views and comments of the Commission.

T€nnette C. Vietti-Cook
Secretary of the Commission

Enclosures:
41. Voting Summary
2. Commissioner Vote Sheets

cc: Chairman Burns
Commissioner Svinicki
Commissioner Ostendorff
Commissioner Baran
OGC
EDO
PDR

SECY Note: This Voting Record to be released to the public 5 working days after issuance of the letter
to the petitioner


NOTATION VOTE

RESPONSE SHEET

TO: Annette Vietti-Cook, Secretary
FROM: Commissioner Ostendorff
SUBJECT: SECY-15-0056: Denial of Petition for Rulemaking
(PRM-32-8)
Approved  X Disapproved Abstain
Not Participating
COMMENTS: Below Attached None
Lit07 bid
SIGNATURE 7”
Yhaliy
DATE

Entered in STARS” Yes No


Request 2
The petitioner requests that the NRC amend 10 CFR 30.19(c) to add that tritium markers

used to label equipment are not considered to be toys or adornments and shall not be sold as

such.

Response to Petitioner’s Request 2

5h-30-49) Jread tat hatthi tion. Fay +,
Paragraph. 30-494 ystatest ption does not or

adoramenis—The requested amendment stating that the tritium markers “shall not be sold” as
toys or adornments would not further control whether these products can be distributed as such.
Additionally, there is no need to expressly designate products that are or are not “toys or
adornments” for purposes of 10 CFR 30.19(c) because NRC staff can apply the normal
dictionary definition of such terms to individual products on a case-by-case basis.

Paragraph 30.19(c) also addresses self-luminous products generally, which makes references
to specific products inappropriate. Most importantly, including a reference to tritium markers
used for labeling purposes would prejudge the product as covered by the exemption, contrary to
the intent of the regulatory framework and the CPPS, which stresses the importance of

case-by-case determinations.

Request 3

The petitioner requests that the NRC amend 10 CFR 30.15 to add a specific exemption

for tritium markers with a maximum activity of 25 millicuries (925 mBgq) of tritium.

Response to Petitioner's Request 3

The NRC is choosingfto}not{include a new specific exemption for these tritium markers
at this time, consistent with the guiding principles within the CPPS. The exempt products in

10 CFR 30.15, such as timepieces or hands or dials containing specified quantities of byproduct
9


Response to Petitioner’s Request 1

Paragraph 32.22(b) allows the NRC to exercise its judgment in denying a license
application when the end use of a product cannot be reasonably foreseen. The requested
amendment would affect all future applications for a license under this section and would reveke
limit the NRC’s ability to deny an applicant based on whether a practice (in this case, the

distribution of certain products for use by the general public) is justified. Being-ableto-preject

the likely-uses-of-a product alse impacts_the-ability- to fully s-_potentialexpoesures-of people
pik ¥ Li Pi ¥ 2 Ee Pi PEOP:
to-radiation-and-to-determine-acceptable_ prototype testing to reflectth: nditions-ofuse—tf
granted,this revision would restrict the NRC's auth rity—Furthermore, this suggested revision

would make 10 CFR 32.22(b) internally inconsistent and essentially would nullify it.

Such a revision would be inconsistent with the NRC’s Consumer Product Policy
Statement, revised in January 2014. In response to a public comment that discussed the issue
of being able to foresee the end uses of products, the Commission explicitly stated the
importance of evaluating products “on a case-by-case basis,” listing a number of considerations
such as likely doses, the probability and severity of accidents and misuse, and the benefits to be
obtained from the product, noting that these cannot be reasonably evaluated if the ultimate uses
of the product are not known (79 FR 2910). The Commission addressed the importance of this
particular regulatory criterion that allows the denial of a distribution license for a product whose
end uses cannot be reasonably foreseen, stating “[sJelf-luminous products in particular have a
wide range of potential applications and might easily be widely used for purposes other than
those originally intended if not clearly designed for a specific use. This criterion also ensures
that the uses. . . of radioactive material in products are justified.” /d. Therefore, the NRC is
reserving the right to exercise its judgment in denying a license application when the end use of

a product cannot be reasonably foreseen.


Request 2
The petitioner requests that the NRC amend 10 CFR 30.19(c) to add that tritium markers

used to label equipment are not considered to be toys or adornments and shall not be sold as

such.

Response to Petitioner's Request 2

Paraaraph 30-19/c) already states that th: motion does-not coverteys-or
grap: DBS ANS ¥ P Y¥

adoraments—The requested amendment stating that the tritium markers “shall not be sold” as
toys or adornments would not further control whether these products can be distributed as such.
Additionally, there is no need to expressly designate products that are or are not “toys or
adornments” for purposes of 10 CFR 30.19(c) because NRC staff can apply the normal
dictionary definition of such terms to individual products on a case-by-case basis.

Paragraph 30.19(c) also addresses self-luminous products generally, which makes references
to specific products inappropriate. MostimportantlyMoreover, including a reference to tritium
markers used for labeling purposes would prejudge the product as covered by the exemption,
contrary to the intent of the regulatory framework and the CPPS, which stresses the importance

of case-by-case determinations.

Request 3
The petitioner requests that the NRC amend 10 CFR 30.15 to add a specific exemption

for tritium markers with a maximum activity of 25 millicuries (925 mBq) of tritium.

Response to Petitioner's Request 3
The NRC is-cheesing-to-not declines to include a new specific exemption for these
tritium markers at this time, consistent with the guiding principles within the CPPS. The exempt

products in 10 CFR 30.15, such as timepieces,or hands or dials containing specified quantities
9


ADDRESSES: Please refer to Docket ID NRC-2013-0078 when contacting the NRC about the
availability of information regarding this petition. You can obtain publicly-available documents
related to the petition using any of the following methods:

« Federal Rulemaking Web site: Go to http://www.regulations.gov and search on the
petition Docket ID NRC-2013-0078. Address questions about NRC dockets to
Carol Gallagher; telephone: 301-287-3422; e-mail: Carol.Gallagher@nre.gov. 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:/Awww.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public

Documents” and then 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 pdr.resource@nrc.gov. The ADAMS accession number for each
document referenced in this document (if that document is available in ADAMS) is provided the
first time that a document is referenced.

« NRC’s PDR: You may examine and purchase copies of public documents at the
NRC's PDR, Room 01-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland

20852.

FOR FURTHER INFORMATION CONTACT: Vanessa Cox, Office of Nuclear Material Safety
and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;

telephone: 301-415-8342; e-mail: Vanessa.Cox@nrc.gov.


ADDRESSES: Please refer to Docket ID NRC-2013-0078 when contacting the NRC about the
availability of information regarding this petition. You can obtain publicly-available documents
related to the petition using any of the following methods:

e Federal Rulemaking Web site: Go to http://www.requlations.gov and search on the
petition Docket ID NRC-2013-0078. Address questions about NRC dockets to
Carol Gallagher; telephone: 301-287-3422; e-mail: Carol.Gallagher@nrc.gov. 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:/Awww.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public

Documents” and then 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 pdr.resource@nrc.gov. The ADAMS accession number for each
document referenced in this document (if that document is available in ADAMS) is provided the
first time that a document is referenced.

* NRC’s PDR: You may examine and purchase copies of public documents at the
NRC’s PDR, Room 01-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland

20852.

FOR FURTHER INFORMATION CONTACT: Vanessa Cox, Office of Nuclear Material Safety
and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;

telephone: 301-415-8342; e-mail: Vanessa.Cox@nrc.gov.


or promethium-147”; and 10 CFR 30.15, “Certain items containing byproduct material.” The
petitioner also provided a dose assessment for the purpose of showing that the tritium markers
would result in acceptably low doses.

The petitioner requests that the NRC amend 10 CFR 32.22(b) to include an additional
requirement stating that an applicant cannot be denied a device registration or distribution
license if they-have-it has adequately demonstrated that the criteria in applicable regulations
have been met. The petitioner contends that the statement in 10 CFR 32.22(b), that “the
Commission may deny an application for a specific license if the end uses of the product cannot
be reasonably foreseen,” is a subjective statement without specific criteria and that it is unfair to
deny applications based upon subjective statements where the criteria are not codified in the
regulations. The petitioner references a Memorandum on Scientific Integrity issued by
President Obama on March 9, 2009, which states that “[s]cience and the scientific process must
inform and guide decisions of [the] Administration on a wide range of issues, including
improvement of public health.” The petitioner notes that the NRC has previously denied
approval of products because end uses of the products could not reasonably be foreseen. The
petitioner also states that the term “frivolous use,” as used in the NRC's policy statement on
consumer products (March 16, 1965, 30 FR 3462; proposed revision October 14, 2011, 76 FR
63957) and in the NRC’s guidance for materials licenses (NUREG-1556, Volume 3, Revision 1,
“Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device
Evaluation and Registration),” (ADAMS Accession No. ML041340618) is not clearly defined and
that there are no detailed criteria used to make determinations. The petitioner asserts that the
potential misuse of a tritium marker as a toy should not result in the product being banned

outright.


NOTATION VOTE

RESPONSE SHEET

TO: Annette Vietti-Cook, Secretary

FROM: Chairman Burns

SUBJECT: SECY-15-0056: Denial of Petition for Rulemaking
(PRM-32-8)

Approved XX __ Disapproved Abstain

Not Participating

COMMENTS: Below XX Attached XX None

| approve denial of the petition for rulemaking and publication of the Federal Register
notice announcing the denial, subject to the attached edits.

(JGNATURE

/¥ May 2015
DATE

Entered in STARS” Yes VA No


VOTING SUMMARY - SECY-15-0056

RECORDED VOTES
APRVD DISAPRVD ABSTAIN PARTICIP COMMENTS DATE
CHRM. BURNS xX Xx 5/14/15
COMR. SVINICKI X Xx 6/8/15
COMR. OSTENDORFF X 4127115
COMR. BARAN X Xx 6/10/15


NOTATION VOTE

RESPONSE SHEET

TO: Annette Vietti-Cook, Secretary

FROM: Commissioner Baran

SUBJECT: SECY-15-0056: Denial of Petition for Rulemaking
(PRM-32-8)

Approved XX__ Disapproved Abstain

Not Participating

COMMENTS: Below XX Attached XX None

| approve denial of the petition for rulemaking and publication of the related Federal Register
notice, subject to the attached edits.

Lf b—
SIGNATURE

Clio [ie
DATE

Entered in STARS” Yes XX No


SUPPLEMENTARY INFORMATION:

TABLE OF CONTENTS:
|. The Petition.
Il. Public Comments on the Petition.
Ill. Discussion.
IV. Reasons for Denial.

V. — Conclusion.

I. The Petition.

Section 2.802 of Title 10 of the Code of Federal Regulations (10 CFR), “Petition for
rulemaking,” provides an opportunity for any interested person to petition the Commission to
issue, amend, or rescind any regulation. The NRC received a petition from Motti Slodowitz on
behalf of CampCo (the petitioner) dated December 2, 2011 (ADAMS Accession No.
ML12132A332). The petition requests that the NRC amend certain regulations concerning
exemptions from licensing for products containing byproduct material to include illumination
tritium markers.

On July 5, 2012 (ADAMS Accession No. ML121580046), the NRC requested
supplemental information to further clarify the request. On September 18, 2012 (ADAMS
Accession No. ML13112B010), the petitioner responded to the NRC’s request and submitted
supplemental information clarifying that the petitioner is requesting the NRC to amend
paragraph (b) of 10 CFR 32.22, “Self-luminous products containing tritium, krypton-85 or
promethium-147: Requirements for license to manufacture, process, produce, or initially

transfer’; paragraph (c) of 10 CFR 30.19, “Self-luminous products containing tritium, krypton-85,

3