[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Proposed Rules]
[Pages 81701-81704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27510]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / 
Proposed Rules  

[[Page 81701]]



DEPARTMENT OF ENERGY

10 CFR Part 835

[Docket No. AU-RM-16-ORP]
RIN 1992-AA51


Occupational Radiation Protection

AGENCY: Office of Environment, Health, Safety and Security, U.S. 
Department of Energy.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The U.S. Department of Energy (DOE) proposes to amend the 
values listed in two appendices to its current occupational radiation 
protection regulations. The proposed amendment to appendix C would 
correct the derived air concentration value for any single radionuclide 
not listed in the appendix C table with a decay mode other than alpha 
emission or spontaneous fission and with radioactive half-life less 
than two hours, adjusted for an 8-hr work day. The proposed amendments 
to appendix E would correct the activity information of two 
radionuclides, Rh-102 and Rh-102m.

DATES: The comment period for this proposed rule will end on December 
19, 2016.

ADDRESSES: You may submit comments, identified by docket number AU-RM-
16-ORP, and/or Regulation Identification Number (RIN) 1992-AA51 in one 
of four ways (please select only one of the ways listed):
    1. Federal e-Rulemaking Portal: http://www.regulations.gov. Follow 
the instructions for submitting comments.
    2. Email: [email protected]. Include docket number AU-RM-16-
ORP and/or RIN 1992-AA51 in the subject line of the email. Please 
include the full body of your comments in the text of the message or as 
an attachment. If you have additional information such as studies or 
journal articles and cannot attach them to your electronic submission, 
please send them on a CD or USB flash drive to the address listed in 
paragraph 4. The additional material must clearly identify your 
electronic comments by name, date, subject, and docket number AU-RM-16-
ORP.
    3. Mail: Address written comments to James Dillard, U.S. Department 
of Energy, Office of Environment, Health, Safety and Security, Mailstop 
AU-11, Docket Number AU-RM-16-ORP, 1000 Independence Ave. SW., 
Washington, DC 20585 (due to potential delays in DOE's receipt and 
processing of mail sent through the U.S. Postal Service, we encourage 
respondents to submit comments electronically to ensure timely 
receipt). If possible, please submit all items on a CD or USB flash 
drive, in which case it is not necessary to include printed copies.
    4. Hand Delivery/Courier: James Dillard, U.S. Department of Energy, 
Office of Environment, Health, Safety and Security, 19901 Germantown 
Road, Germantown, MD 20874. Telephone 301-903-1165. If possible, please 
submit all items on a CD or USB flash drive, in which case it is not 
necessary to include printed copies.
    For detailed instructions on submitting comments and additional 
information on the rulemaking process, see Section IV of this document 
(Public Participation).
    Docket: The docket, which includes Federal Register notices, public 
meeting attendee lists and transcripts, comments, and other supporting 
documents/materials, is available for review at http://www.regulations.gov. All documents in the docket are listed in the 
www.regulations.gov index. However, some documents listed in the index, 
such as those containing information that is exempt from public 
disclosure, may not be publicly available. A link to the docket Web 
page can be found at: http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title10/10cfr835_main_02.tpl. The www.regulations.gov Web 
page contains instructions on how to access all documents, including 
public comments, in the docket. See Section IV of this document (Public 
Participation) for further information on how to submit comments 
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: James Dillard, U.S. Department of 
Energy, Office of Environment, Health, Safety and Security, Mailstop 
AU-11, 1000 Independence Ave. SW., Washington, DC 20585. Telephone: 
301-903-1165. Email: [email protected].

SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion of Proposed Amendments
    A. Appendix C--Derived Air Concentration (DAC) for Workers From 
External Exposure During Immersion in a Cloud of Airborne 
Radioactive Material
    B. Appendix E--Values for Establishing Sealed Radioactive Source 
Accountability and Radioactive Material Posting and Labeling 
Requirements
III. Procedural Requirements
    A. Review Under Executive Orders 12866 and 13563
    B. Review Under the Regulatory Flexibility Act
    C. Review Under the Paperwork Reduction Act
    D. Review Under the National Environmental Policy Act
    E. Review Under Executive Order 12988
    F. Review Under Executive Order 13132
    G. Review Under Executive Order 13175
    H. Review Under the Unfunded Mandates Reform Act of 1995
    I. Review Under Executive Order 13211
    J. Review Under the Treasury and General Government 
Appropriations Act, 1999
    K. Review Under the Treasury and General Government 
Appropriations Act, 2001
IV. Public Participation
V. Approval of the Office of the Secretary.

I. Background

    The requirements in title 10, Code of Federal Regulations, part 835 
(10 CFR part 835), Occupational Radiation Protection, are designed to 
protect the health and safety of individuals from ionizing radiation 
resulting from the conduct of U.S. Department of Energy (DOE) 
activities. One situation that DOE's regulations address is the 
exposure of workers to radioactive material dispersed in the air. Based 
on calculations involving doses to the organs of the body, levels of 
contamination in the air that will not cause the dose limits for 
workers to be exceeded are established for specified radionuclides. 
These values are provided in appendix C of part 835. On April 13, 2011, 
the Department published updated Derived Air Concentration (DAC) values 
in appendix C for determining radiation dose from inhaled radioactive 
material (76 FR 20489). The updated dose conversion factors were based 
on an 8 hour work day exposure time instead of the previously assumed 
24 hour calendar day exposure, which is consistent with other 
occupational scenarios, such as

[[Page 81702]]

those used in developing appendix A DACs. In that update, the DAC 
values for radionuclides not listed in the appendix C table with a 
decay mode other than alpha emission or spontaneous fission and with 
radioactive half-life less than two hours were inadvertently not 
revised for the 8 hour work day exposure time. The proposed amendment 
to appendix C would provide the correct DAC values for this group of 
radioactive materials.
    Title 10 CFR part 835 appendix E values were developed to ensure 
the proper accountability of sealed radioactive sources, as well as 
radioactive material posting and labeling requirements (63 FR 59662, 
November 4, 1998). DOE most recently amended the values of appendix E 
to part 835 on June 8, 2007 (72 FR 31904), using the International 
Commission on Radiological Protection (ICRP) Publication 60 methodology 
(ref. 1) and the same exposure scenarios discussed in a 1998 amendment 
to 10 CFR part 835 (63 FR 59662, November 4, 1998). The values were 
based on the more limiting of the quantity of radioactive material 
which results in either an external or internal whole body dose, from 
either inhalation or ingestion, of 100 millirems. However, the final 
rule incorrectly listed values for two radionuclides. This proposed 
amendment to appendix E would provide the correct activity values for 
these two radionuclides (Rh-102 and Rh-102m), calculated from internal 
exposure scenario derived from ICRP Publication 119 (ref. 2).

II. Discussion of Proposed Amendments

    A. Appendix C--Derived Air Concentration (DAC) for Workers from 
External Exposure During Immersion in a Cloud of Airborne Radioactive 
Material. The proposed amendment would provide a correction to the 
derived air concentration value for any single radionuclide not listed 
in the Appendix C table with a decay mode other than alpha emission or 
spontaneous fission and with radioactive half-life less than two hours 
to 1E-06 [micro]Ci/mL (7E+04 Bq/m\3\).
    B. Appendix E--Values for Establishing Sealed Radioactive Source 
Accountability and Radioactive Material Posting and Labeling 
Requirements. The proposed amendment would correct the activity for Rh-
102 to 6.4E+05 [micro]Ci and the activity from Rh-102m to 3.0E+05 
[micro]Ci.

III. Procedural Requirements

A. Review Under Executive Order 12866

    This regulatory action has been determined not to be ``not 
significant'' under Executive Order 12866, ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Accordingly, this action was 
not subject to review under that Executive Order by the Office of 
Information and Regulatory Affairs (OIRA) of the Office of Management 
and Budget (OMB).

B. Review Under the Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) 
requires that a Federal agency prepare an initial regulatory 
flexibility analysis for any regulation for which a general notice of 
proposed rulemaking is required, unless the agency certifies that the 
rule, if promulgated, will not have a significant economic impact on a 
substantial number of small entities (5 U.S.C. 605(b)).
    This proposed rule would amend DOE requirements for nuclear safety 
and occupational radiation protection at DOE sites. The requirements of 
part 835 are primarily implemented by contractors who conduct work at 
DOE facilities. DOE considered whether these contractors are ``small 
businesses'' as the term is defined in the Regulatory Flexibility Act 
(5 U.S.C. 601(3)). The Regulatory Flexibility Act's definition 
incorporates the definition of small business concerns in the Small 
Business Act, which the Small Business Administration (SBA) has 
developed through size standards in 13 CFR part 121. The DOE 
contractors subject to this rule exceed the SBA's size standards for 
small businesses. In addition, DOE expects that any potential economic 
impact of this rule would be negligible because DOE activities are 
conducted by contractors who are reimbursed through their contracts 
with DOE for the costs of complying with DOE nuclear safety and 
radiation protection requirements, including the costs of complying 
with the proposed rule. For these reasons, DOE certifies that this 
proposed rule, if promulgated, would not have a significant economic 
impact on a substantial number of small entities, and therefore, no 
regulatory flexibility analysis has been prepared. DOE's certification 
and supporting statement of factual basis will be provided to the Chief 
Counsel of Advocacy of the SBA pursuant to 5 U.S.C. 605(b).

C. Review Under the Paperwork Reduction Act

    This proposed rule does not impose a collection of information 
requirement subject to the Paperwork Reduction Act (44 U.S.C. 3501 et 
seq.).

D. Review Under the National Environmental Policy Act

    DOE has concluded that promulgation of this rule falls into a class 
of actions that would not individually or cumulatively have a 
significant impact on the human environment, as determined by DOE's 
regulations implementing the National Environmental Policy Act of 1969 
(42 U.S.C. 4321 et seq.). Specifically, this rule amends existing 
regulations without changing the potential environmental effect of the 
regulations being amended, and, therefore, is covered under the 
Categorical Exclusion in paragraph A5 of appendix A to subpart D, 10 
CFR part 1021. Accordingly, neither an environmental assessment nor an 
environmental impact statement is required.

E. Review Under Executive Order 12988

    With respect to the review of existing regulations and the 
promulgation of new regulations, section 3(a) of Executive Order 12988, 
``Civil Justice Reform'' (61 FR 4729, February 7, 1996), imposes on 
Federal agencies the general duty to adhere to the following 
requirements: (1) Eliminate drafting errors and ambiguity; (2) write 
regulations to minimize litigation; and (3) provide a clear legal 
standard for affected conduct rather than a general standard and 
promote simplification and burden reduction. Section 3(b)(2) of 
Executive Order 12988 specifically requires that Executive agencies 
make every reasonable effort to ensure that the regulation: (1) Clearly 
specifies the preemptive effect, if any, to be given to the regulation; 
(2) clearly specifies any effect on existing Federal law or regulation; 
(3) provides a clear legal standard for affected conduct while 
promoting simplification and burden reduction; (4) specifies the 
retroactive effect, if any, to be given to the regulation; (5) defines 
key terms; and (6) addresses other important issues affecting clarity 
and general draftsmanship under any guidelines issued by the Attorney 
General. Section 3(c) of Executive Order 12988 requires Executive 
agencies to review regulations in light of applicable standards in 
section 3(a) and section 3(b) to determine whether they are met or it 
is unreasonable to meet one or more of the standards. DOE has completed 
the

[[Page 81703]]

required review and determined that, to the extent permitted by law, 
this proposed rule meets the relevant standards of Executive Order 
12988.

F. Review Under Executive Order 13132

    Executive Order 13132, ``Federalism'' (64 FR 43255, August 4, 
1999), imposes certain requirements on agencies formulating and 
implementing policies or regulations that preempt State law or that 
have federalism implications. Agencies are required to examine the 
constitutional and statutory authority supporting any action that would 
limit the policymaking discretion of the States and carefully assess 
the necessity for such actions. DOE has examined this proposed rule and 
has determined that it would not preempt State law and would not have a 
substantial direct effect on the States, the relationship between the 
national government and the States, or the distribution of power and 
responsibilities among the various levels of government. No further 
action is required by Executive Order 13132.

G. Review Under Executive Order 13175

    Under Executive Order 13175 (65 FR 67249, November 6, 2000) on 
``Consultation and Coordination with Indian Tribal Governments,'' DOE 
may not issue a discretionary rule that has ``tribal'' implications and 
imposes substantial direct compliance costs on Indian tribal 
governments. DOE has determined that the proposed rule would not have 
such effects and concluded that Executive Order 13175 does not apply to 
this proposed rule.

H. Review Under the Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), 2 U.S.C. 1531 et seq., requires each Federal agency to prepare a 
written assessment of the effects of any Federal mandate in a proposed 
or final agency regulation that may result in the expenditure by 
states, tribal, or local governments, on the aggregate, or by the 
private sector, of $100 million in any one year. The Act also requires 
a Federal agency to develop an effective process to permit timely input 
by elected officials of state, tribal, or local governments on a 
proposed ``significant intergovernmental mandate,'' and requires an 
agency plan for giving notice and opportunity to provide timely input 
to potentially affected small governments before establishing any 
requirements that might significantly or uniquely affect small 
governments. DOE has determined that the proposed rule published does 
not contain any Federal mandates affecting small governments, so these 
requirements do not apply.

I. Review Under Executive Order 13211

    Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use,'' 66 FR 28355 
(May 22, 2001) requires Federal agencies to prepare and submit to the 
OMB a Statement of Energy Effects for any proposed significant energy 
action. A ``significant energy action'' is defined as any action by an 
agency that promulgated or is expected to lead to promulgation of a 
final rule, and that: (1) Is a significant regulatory action under 
Executive Order 12866, or any successor order; and (2) is likely to 
have a significant adverse effect on the supply, distribution, or use 
of energy, or (3) is designated by the Administrator of OIRA as a 
significant energy action. For any proposed significant energy action, 
the agency must give a detailed statement of any adverse effects on 
energy supply, distribution, or use should the proposal be implemented, 
and of reasonable alternatives to the action and their expected 
benefits on energy supply, distribution, and use. This regulatory 
action would not have a significant adverse effect on the supply, 
distribution, or use of energy and is therefore not a significant 
energy action. Accordingly, DOE has not prepared a Statement of Energy 
Effects.

J. Review Under the Treasury and General Government Appropriations Act, 
1999

    Section 654 of the Treasury and General Government Appropriations 
Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family 
Policymaking Assessment for any proposed rule that may affect family 
well-being. The proposed rule would not have any impact on the autonomy 
or integrity of the family as an institution. Accordingly, DOE has 
concluded that it is not necessary to prepare a Family Policymaking 
Assessment.

K. Review Under the Treasury and General Government Appropriations Act, 
2001

    The Treasury and General Government Appropriations Act, 2001 (44 
U.S.C. 3516 note) provides for agencies to review most disseminations 
of information to the public under guidelines established by each 
agency pursuant to general guidelines issued by OMB.
    OMB's guidelines were published at 67 FR 8452 (February 22, 2002), 
and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). 
DOE has reviewed this proposed rule under the OMB and DOE guidelines 
and has concluded that it is consistent with applicable policies in 
those guidelines.

IV. Public Participation

Submission of Comments

    DOE will accept comments, data and information regarding this 
proposed rule before or after the public hearings, but no later than 
the date provided in the DATES section at the beginning of this 
proposed rule. Interested individuals are invited to participate in 
this proceeding by submitting data, views, or arguments with respect to 
this proposed rule using any of the methods described in the ADDRESSES 
section at the beginning of this proposed rule. To help the Department 
review the submitted comments, commenters are requested to reference 
the paragraph(s), e.g., Sec.  835.3(a), to which they refer where 
possible.
    1. Submitting comments via www.regulations.gov. The 
www.regulations.gov Web page will require you to provide your name and 
contact information. Your contact information will be viewable to DOE's 
Office of Environment, Health, Safety and Security staff only. Your 
contact information will not be publicly viewable except for your first 
and last names, organization name (if any), and submitter 
representative name (if any). If your comment is not processed properly 
because of technical difficulties, DOE will use this information to 
contact you. If DOE cannot read your comment due to technical 
difficulties and cannot contact you for clarification, DOE may not be 
able to consider your comment. However, your contact information will 
be publicly viewable if you include it in the comment itself or in any 
documents attached to your comment. Any information that you do not 
want to be publicly viewable should not be included in your comment, 
nor in any document attached to your comment. Otherwise, persons 
viewing comments will see only first and last names, organization 
names, correspondence containing comments, and any documents submitted 
with the comments.
    Do not submit to www.regulations.gov information for which 
disclosure is restricted by statute, such as trade secrets and 
commercial or financial information (hereinafter referred to as 
Confidential Business Information (CBI)). Comments submitted through 
www.regulations.gov cannot be claimed as CBI. Comments received through 
the

[[Page 81704]]

Web site will waive any CBI claims for the information submitted. For 
information on submitting CBI, see the Confidential Business 
Information section below.
    DOE processes submissions made through www.regulations.gov before 
posting them. Normally, comments will be posted within a few days of 
being submitted. However, if large volumes of comments are being 
processed simultaneously, your comment may not be viewable for up to 
several weeks. Please keep the comment tracking number that 
www.regulations.gov provides after you have successfully uploaded your 
comment.
    2. Submitting comments via email, mail or hand delivery/courier. 
Comments and documents submitted via email, mail, or hand delivery/
courier, also will be posted to www.regulations.gov. If you do not want 
your personal contact information to be publicly viewable, do not 
include it in your comment or any accompanying documents. Instead, 
provide your contact information in a cover letter. Include your first 
and last names, email address, telephone number, and optional mailing 
address. The cover letter will not be publicly viewable as long as it 
does not include any comments.
    Include contact information each time you submit comments, data, 
documents, and other information to DOE. If you submit via mail or hand 
delivery/courier, please provide all items on a CD or USB flash drive, 
if feasible. It is not necessary to submit printed copies. No 
facsimiles (faxes) will be accepted.
    Comments, data, and other information submitted to DOE 
electronically should be provided in PDF (preferred), Microsoft Word or 
Excel, WordPerfect, or text (ASCII) file format. Provide documents that 
are not secured, that are written in English, and that are free of any 
defects or viruses. Documents should not contain special characters or 
any form of encryption and, if possible, they should carry the 
electronic signature of the author.
    3. Confidential Business Information. Pursuant to the provisions of 
10 CFR 1004.11, anyone submitting information or data he or she 
believes to be confidential and exempt by law from public disclosure 
should submit via email, or postal mail two well-marked copies: One 
copy of the document marked ``CONFIDENTIAL BUSINESS INFORMATION'' 
including all the information believed to be confidential, and one copy 
of the document marked ``NO CONFIDENTIAL BUSINESS INFORMATION'' with 
the information believed to be confidential deleted. Submit these 
documents via email or CD, if feasible. DOE will make its own 
determination as to the confidentiality of the information and treat it 
accordingly. Factors of interest to DOE when evaluating requests to 
treat submitted information as confidential include: (1) A description 
of the items; (2) whether and why such items are customarily treated as 
confidential within the industry; (3) whether the information is 
generally known by or available from other sources; (4) whether the 
information has previously been made available to others without 
obligation concerning its confidentiality; (5) an explanation of the 
competitive injury to the submitting person which would result from 
public disclosure; (6) when such information might lose its 
confidential character due to the passage of time; and (7) why 
disclosure of the information would be contrary to the public interest.
    It is DOE's policy that all comments may be included in the public 
docket, without change and as received, including any personal 
information provided in the comments (except information deemed to be 
exempt from public disclosure).
    4. Campaign form letters. Please submit campaign form letters by 
the originating organization in batches of between 50 to 500 form 
letters per PDF or as one form letter with a list of supporters' names 
compiled into one or more PDFs. This reduces comment processing and 
posting time.

Appendix A--References

1. International Commission on Radiological Protection (ICRP), 1994. 
Dose Coefficients for Intakes of Radionuclides by Workers. ICRP 
Publication 68. Ann. ICRP 24 (4).
2. ICRP, 2012. Corrigenda to ICRP Publication 119: Compendium of 
Dose Coefficients based on ICRP Publication 60. Ann. ICRP 41 
(suppl.).

V. Approval of the Office of the Secretary

    The Secretary of Energy has approved publication of this proposed 
rule.

List of Subjects in 10 CFR Part 835

    Federal buildings and facilities, Nuclear energy, Nuclear 
materials, Nuclear power plants and reactors, Nuclear safety, 
Occupational safety and health, Radiation protection, and Reporting and 
recordkeeping requirements.

    Issued in Washington, DC, on October 31, 2016.
Matthew B. Moury,
Associate Under Secretary for Environment, Health, Safety and Security.

    For the reasons set forth in the preamble, the Department of Energy 
proposes to amend part 835 of chapter III of title 10 of the Code of 
Federal Regulations as set forth below:

PART 835--OCCUPATIONAL RADIATION PROTECTION

0
1. The authority citation for part 835 continues to read as follows:

    Authority:  42 U.S.C. 2201, 7191, 50 U.S.C. 2410.

Appendix C to Part 835--[Amended]

0
2. At the end of the table, in appendix C, the last sentence is amended 
by removing ``6 E-06 [mu]Ci/mL (2 E+04 Bq/m\3\)'' and adding in its 
place ``1 E-06 [micro]Ci/mL (7 E+04 Bq/m\3\)''.

Appendix E to Part 835--[Amended]

0
3. Appendix E is amended by removing the activity value in the second 
column for:
0
a. Rh-102, value of ``3.0E+05'' and adding in its place ``6.4E+05''; 
and
0
b. Rh-102m, value of ``6.4E+05'' and adding in its place ``3.0E+05''.

[FR Doc. 2016-27510 Filed 11-17-16; 8:45 am]
 BILLING CODE 6450-01-P