80 FR 45413 - Commercial Distribution of Tritium Markers

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range		45413-45415
FR Document		2015-18630
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 Motti Slodowitz on behalf of 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.
Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015)
[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Rules and Regulations]
[Pages 45413-45415]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18630]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

10 CFR Part 32

[Docket Nos. PRM-32-8; NRC-2013-0078]


Commercial Distribution of Tritium Markers

AGENCY: 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 Motti Slodowitz on behalf of 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 July 30, 2015.

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-
415-3463; email: 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://www.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 email to pdr.resource@nrc.gov. 
The ADAMS accession number for each document referenced (if it is 
available in ADAMS) is provided the first time that it is mentioned in 
the SUPPLEMENTARY INFORMATION section.
     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: Vanessa Cox, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-8342; email: 
Vanessa.Cox@nrc.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. The Petition
II. Public Comments on the Petition
III. 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 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, 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 it

[[Page 45414]]

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 (30 FR 3462; March 16, 1965, 
proposed revision 76 FR 63957; October 14, 2011) 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.
    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.

II. Public Comments on the Petition

    The notice of receipt published in the Federal Register (78 FR 
41720; July 11, 2013), 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.

    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.

III. 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 intially transfer for sale or 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 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.
    The NRC's Consumer Product Policy Statement (CPPS or policy) (79 FR 
2907; January 16, 2014) 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 it has adequately demonstrated 
that the criteria in the applicable regulations have been met.
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 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)

[[Page 45415]]

is justified. 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 CPPS, revised 
in January 2014. In response to a public comment that discussed the 
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 
``[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. 
This criterion also ensures that the uses . . . of radioactive material 
in products are justified.'' Id. Therefore, it is important for the NRC 
to be able 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
    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. Moreover, 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 not 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 timepiece hands or dials containing specified quantities 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 consideration 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 
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 limited. 
Also, self-luminous products containing tritium light sources 
incorporated into products with clear end uses can provide some of the 
same benefits.
    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,'' 
suggest that this product should not be exempted. However, 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 or that the existing 
regulatory framework for self-luminous products is inappropriate. The 
tritium markers do not meet the regulatory criteria for 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. This provision is needed 
to ensure that the use of radioactive material in a product is 
justified.

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 22nd day of July, 2015.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2015-18630 Filed 7-29-15; 8:45 am]
 BILLING CODE 7590-01-P
45414 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations

has adequately demonstrated that the items, and helping lost campers find receive a specific license under 10 CFR
criteria in applicable regulations have their tents. 32.22 and must have the product
been met. The petitioner contends that registered under 10 CFR 32.210.
II. Public Comments on the Petition
the statement in 10 CFR 32.22(b), that Applicants for licenses under 10 CFR
‘‘the Commission may deny an The notice of receipt published in the 32.22 must also demonstrate that the
application for a specific license if the Federal Register (78 FR 41720; July 11, product is designed and manufactured
end uses of the product cannot be 2013), invited interested persons to in accordance with the safety criteria in
reasonably foreseen,’’ is a subjective submit comments. The comment period 10 CFR 32.23. Paragraph 32.22(b)
statement without specific criteria and closed on September 24, 2013. The NRC further indicates that the Commission
that it is unfair to deny applications received one public comment opposing may deny an application for a specific
based upon subjective statements where the petition. The commenter states: license if the end uses of the product
the criteria are not codified in the An interest in record keeping in the known cannot be reasonably foreseen.
regulations. The petitioner references a supply of tritium should be recognized since Section 30.15 provides a list of
Memorandum on Scientific Integrity tritium may, in some cases, be the only product-specific exemptions for certain
issued by President Obama on March 9, useful tracer for a smuggled weapon. An products containing byproduct material,
2009, which states that ‘‘[s]cience and unrecorded presence of legitimately obtained
tritium may lead to too many false positives
subject to certain limits including
the scientific process must inform and during a crisis. specific radionuclide quantity limits.
guide decisions of [the] Administration The receipt, possession, use, transfer,
on a wide range of issues, including Although the NRC is denying the ownership, and acquisition of these
improvement of public health.’’ The petition, the NRC disagrees with the products, which includes self-luminous
petitioner notes that the NRC has commenter that the presence of tritium timepieces, hands, and dials, are exempt
previously denied approval of products in approved consumer products would from licensing requirements. Persons
because end uses of the products could negatively affect law enforcement efforts wishing to apply or incorporate
not reasonably be foreseen. The to track illegal weapons. byproduct material into these products
petitioner also states that the term III. Discussion or initially transfer them for sale or
‘‘frivolous use,’’ as used in the NRC’s distribution must apply for a specific
policy statement on consumer products The NRC regulates consumer products
containing byproduct material without license under 10 CFR 32.14. Unlike
(30 FR 3462; March 16, 1965, proposed products covered by the 10 CFR 30.19
revision 76 FR 63957; October 14, 2011) imposing regulatory controls on the
consumer-user. Those who manufacture class exemption, specific products listed
and in the NRC’s guidance for materials in 10 CFR 30.15 do not need to be
licenses (NUREG–1556, Volume 3, or distribute products containing
byproduct material, including consumer registered under 10 CFR 32.210 in order
Revision 1, ‘‘Consolidated Guidance for one to obtain a specific license for
About Materials Licenses: Applications products, must have a license issued
under 10 CFR part 32. Exemptions for distribution.
for Sealed Source and Device Evaluation The NRC’s Consumer Product Policy
and Registration’’ (ADAMS Accession users of products containing byproduct
material appear in 10 CFR part 30. Statement (CPPS or policy) (79 FR 2907;
No. ML041340618)), is not clearly January 16, 2014) provides the
defined and that there are no detailed These exemptions are either product-
specific or class exemptions. Commission’s policy with respect to
criteria used to make determinations. approval of the use of byproduct,
The petitioner asserts that the potential A class exemption covers a class of
products, for which a person who source, and special nuclear material in
misuse of a tritium marker as a toy products intended for use by the general
should not result in the product being wishes to manufacture or distribute a
specific product within that class may public (consumer products) without the
banned outright. imposition of regulatory controls on the
The petitioner requests that the NRC submit a license application. An
applicant must provide safety consumer-user. The revision of the
also amend 10 CFR 30.19(c) to add that consumer product policy statement was
tritium markers used to label equipment information about the product and
demonstrate that the product meets a finalized after the petition was filed.
are not considered to be toys or
adornments and shall not be sold as number of safety criteria. Exemption of Petitioner’s Requests
such. a product under a class exemption is
The petitioner also requests that the dependent on approval under the Request 1
NRC amend 10 CFR 30.15 to add a applicable regulations for the The petitioner requests that the NRC
specific exemption for tritium markers distributor. amend 10 CFR 32.22(b) to include a
with a maximum activity of 25 Section 30.19 is a class exemption for statement that an applicant cannot be
millicuries (925 mBq) of tritium. The the receipt, possession, use, transfer, denied a device registration or
petitioner believes an exemption is ownership, or acquisition of self- distribution license if it has adequately
warranted because of the usefulness of luminous products containing certain demonstrated that the criteria in the
the tritium markers and the low dose radionuclides, including tritium. This applicable regulations have been met.
potential. The petitioner states that the exemption does not apply to persons
who manufacture, process, produce, or Response to Petitioner’s Request 1
markers would not be a frivolous use of
radioactive material, and that ‘‘the initially transfer such products for sale Paragraph 32.22(b) allows the NRC to
potential radiation doses to members of or distribution. Paragraph (c) in 10 CFR exercise its judgment in denying a
the public under normal use and 30.19 states that the exemption for license application when the end use of
accident conditions...are within products containing tritium, krypton-85, a product cannot be reasonably
regulatory limits.’’ The petitioner also or promethium-147 does not apply to foreseen. The requested amendment
Lhorne on DSK7TPTVN1PROD with RULES

states that the markers are sold in other products primarily for frivolous would affect all future applications for
countries and have practical benefit purposes or in toys or adornments. a license under this section and would
such as helping military personnel Those who wish to intially transfer for limit the NRC’s ability to deny an
recover lost items, helping first sale or distribution self-luminous applicant based on whether a practice
responders locate tagged equipment at products covered by the 10 CFR 30.19 (in this case, the distribution of certain
night, assisting hunters in finding lost class exemption must first apply for and products for use by the general public)

VerDate Sep<11>2014 13:32 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\30JYR1.SGM 30JYR1
Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 45415

is justified. Furthermore, this suggested importance of case-by-case the amount of light created using the 25
revision would make 10 CFR 32.22(b) determinations. mCi of tritium suggested for the new
internally inconsistent and essentially exemption is limited. Also, self-
Request 3
would nullify it. luminous products containing tritium
Such a revision would be inconsistent The petitioner requests that the NRC light sources incorporated into products
with the NRC’s CPPS, revised in January amend 10 CFR 30.15 to add a specific with clear end uses can provide some of
2014. In response to a public comment exemption for tritium markers with a
the same benefits.
that discussed the ability to foresee the maximum activity of 25 millicuries (925
mBq) of tritium. The petitioner stated that the tritium
end uses of products, the Commission
markers are sold in other countries. The
explicitly stated the importance of Response to Petitioner’s Request 3 discussion in the CPPS recognizes that
evaluating products ‘‘on a case-by-case The NRC is choosing not to include a it is unavoidable that there will be some
basis,’’ listing a number of new specific exemption for these tritium
considerations such as likely doses, the differences made in judgments
markers at this time, consistent with the concerning justification of practice.
probability and severity of accidents guiding principles within the CPPS. The
and misuse, and the benefits to be Generally, international standards, such
exempt products in 10 CFR 30.15, such as the International Atomic Energy
obtained from the product, noting that as timepiece hands or dials containing
these cannot be reasonably evaluated if Agency’s ‘‘Radiation Protection and
specified quantities of byproduct Safety of Radiation Sources:
the ultimate uses of the product are not material including tritium, or marine
known (79 FR 2910). The Commission International Basic Safety Standards,’’
compasses containing tritium, are
addressed the importance of this suggest that this product should not be
designed for specific uses. As
particular regulatory criterion that previously indicated, the Commission exempted. However, individual
allows the denial of a distribution has stated that ‘‘[s]elf-luminous countries’ regulatory bodies make their
license for a product whose end uses products in particular have a wide range own judgments.
cannot be reasonably foreseen, stating of potential applications and might
‘‘[s]elf-luminous products in particular IV. Reasons for Denial
easily be widely used for purposes other
have a wide range of potential than those originally intended if not The NRC is denying the petition
applications and might easily be widely clearly designed for a specific use’’ (79 because the petitioner fails to
used for purposes other than those FR 2910). Based on the small size (1.8 demonstrate that a specific exemption is
originally intended if not clearly cm long by 0.8 cm diameter by 0.2 cm warranted or that the existing regulatory
designed for a specific use. This thick) and the design of the tritium framework for self-luminous products is
criterion also ensures that the uses . . . markers, the tritium markers have inappropriate. The tritium markers do
of radioactive material in products are potential uses beyond those intended by not meet the regulatory criteria for the
justified.’’ Id. Therefore, it is important the petitioner, including as decorations
for the NRC to be able to exercise its use of self-luminous products under an
on zipper pulls on clothing or as exemption from licensing. In addition,
judgment in denying a license jewelry. The lack of a clear design for
application when the end use of a the self-luminous product class
a specific use creates greater potential
product cannot be reasonably foreseen. exemption was set up to eliminate the
for unintended uses (such as the ones
specifically excluded from the need to evaluate numerous PRMs for a
Request 2 wide variety of self-luminous products
exemption in 10 CFR 30.19), which
The petitioner requests that the NRC outweighs the product’s beneficial uses. and the need to conduct a separate
amend 10 CFR 30.19(c) to add that Because of the potential for widespread rulemaking to add individual
tritium markers used to label equipment use, careful consideration of exemptions for each acceptable one.
are not considered to be toys or justification of practice is important. This provision is needed to ensure that
adornments and shall not be sold as Also, the size and glow-in-the-dark the use of radioactive material in a
such. nature of the tritium markers would product is justified.
appeal to and be accessible to children.
Response to Petitioner’s Request 2 V. Conclusion
Creating a new specific exemption for
The requested amendment stating that these tritium markers would be For the reasons cited in this
the tritium markers ‘‘shall not be sold’’ inconsistent with the CPPS, in document, the NRC is denying PRM–
as toys or adornments would not further particular, paragraph four (79 FR 2912), 32–8. The petition fails to present any
control whether these products can be which requires that products subject to significant new information or
distributed as such. Additionally, there mishandling, especially by children, arguments that would warrant the
is no need to expressly designate require an unusual degree of safety and
requested amendments.
products that are or are not ‘‘toys or utility. This criterion is unchanged from
adornments’’ for purposes of 10 CFR the original 1965 version of the policy. Dated at Rockville, Maryland, this 22nd
30.19(c) because NRC staff can apply the The tritium markers do not meet this day of July, 2015.
normal dictionary definition of such criterion as they do not provide an For the Nuclear Regulatory Commission.
terms to individual products on a case- unusual degree of utility. The unique Annette L. Vietti-Cook,
by-case basis. Paragraph 30.19(c) also benefits as compared to other Secretary of the Commission.
addresses self-luminous products alternatives are relatively limited. For [FR Doc. 2015–18630 Filed 7–29–15; 8:45 am]
generally, which makes references to example, the uses of the tritium markers
BILLING CODE 7590–01–P
specific products inappropriate. asserted by the petitioner can be
Lhorne on DSK7TPTVN1PROD with RULES

Moreover, including a reference to achieved by other products on the
tritium markers used for labeling market, such as battery-powered
purposes would prejudge the product as products. While the use of tritium
covered by the exemption, contrary to presents a particular benefit by staying
the intent of the regulatory framework illuminated continuously without
and the CPPS, which stresses the having to be turned on when needed,

VerDate Sep<11>2014 13:32 Jul 29, 2015 Jkt 235001 PO 00000 Frm 00021 Fmt 4700 Sfmt 9990 E:\FR\FM\30JYR1.SGM 30JYR1
Document Created: 2018-02-23 09:30:14
Document Modified: 2018-02-23 09:30:14
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Petition for rulemaking; denial.
Dates		The docket for the petition for rulemaking, PRM-32-8, is closed on July 30, 2015.
Contact		Vanessa Cox, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8342; email: [email protected]
FR Citation		80 FR 45413