80 FR 21274 - Guidance for Evaluation of Acute Chemical Exposures and Proposed Quantitative Standards

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 74 (April 17, 2015)

The U.S. Nuclear Regulatory Commission (NRC) is providing supplemental information to an earlier notice, appearing in the Federal Register on March 4, 2015, which requested comment on a draft interim staff guidance (ISG), ``Guidance for Evaluation of Acute Chemical Exposures and Proposed Quantitative Standards.'' The draft ISG, if issued in final form, would supplement existing guidance in NUREG-1520, ``Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility,'' by providing additional guidance and the descriptions of proposed quantitative standards for the NRC to follow when evaluating the integrated safety analysis (ISAs) of acute chemical exposures. This action is necessary to provide the public with the backfitting information with respect to the draft ISG, and includes references to the key documents on backfitting issues. The public comment period was originally scheduled to close on May 18, 2015. The NRC is extending the public comment period on this action to allow more time for members of the public to review the additional information on backfitting before submitting any comments.

[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21274-21277]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08932]


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NUCLEAR REGULATORY COMMISSION

[NRC-2015-0044]


Guidance for Evaluation of Acute Chemical Exposures and Proposed 
Quantitative Standards

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft interim staff guidance; supplemental information; 
extension of comment period.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is providing 
supplemental information to an earlier notice, appearing in the Federal 
Register on March 4, 2015, which requested comment on a draft interim 
staff guidance (ISG), ``Guidance for Evaluation of Acute Chemical 
Exposures and Proposed Quantitative Standards.'' The draft ISG, if 
issued in final form, would supplement existing guidance in NUREG-1520, 
``Standard Review Plan for the Review of a License Application for a 
Fuel Cycle Facility,'' by providing additional guidance and the 
descriptions of proposed quantitative standards for the NRC to follow 
when evaluating the integrated safety analysis (ISAs) of acute chemical 
exposures. This action is necessary to provide the public with the 
backfitting information with respect to the draft ISG, and includes 
references to the key documents on backfitting issues. The public 
comment period was originally scheduled to close on May 18, 2015. The 
NRC is extending the public comment period on this action to allow more 
time for members of the public to review the additional information on 
backfitting before submitting any comments.

DATES: The due date of comments requested in the document published on 
March 4, 2015 (80 FR 11692) is extended. Comments should be filed no 
later than July 1, 2015. Comments received after this date will be 
considered if it is practical to do so, but the Commission is able to 
ensure consideration only for comments received before this date.

ADDRESSES: You may submit comments by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0044. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Mail comments to: Cindy Bladey, Office of Administration, 
Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
    For additional direction on accessing information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Marilyn Diaz, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington DC

[[Page 21275]]

20555-0001; telephone: 301-415-7110, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2015-0044 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0044.
     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 [email protected]. The 
draft ISG is available in ADAMS under Accession No. ML15051A029.
     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.

B. Submitting Comments

    Please include Docket ID NRC-2015-0044 in the subject line of your 
comment submission, in order to ensure that the NRC is able to make 
your comment submission available to the public in this docket.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment submissions into ADAMS.

II. Background

    The NRC is providing supplemental information to a notice 
requesting comment on its draft ISG, ``Guidance for Evaluation of Acute 
Chemical Exposures and Proposed Quantitative Standards,'' that was 
published in the Federal Register (80 FR 11692; March 4, 2015). The 
draft ISG, if issued in final form, would supplement existing guidance 
in NUREG-1520, ``Standard Review Plan for the Review of a License 
Application for a Fuel Cycle Facility'' (ADAMS Accession No. 
ML101390110), by providing additional guidance for the NRC to follow 
when evaluating the ISAs of acute chemical exposures, including the 
descriptions of proposed quantitative standards used to classify 
exposure events using the general criteria of section 70.61 of title 10 
of the Code of Federal Regulations (10 CFR). The draft ISG identifies 
sources of information that the staff could use when reviewing the 
proposed quantitative standards.
    This supplemental information provides the NRC's proposed position 
on backfitting with respect to the draft ISG, and includes references 
to the key documents on backfitting. The public comment period was 
originally scheduled to close on May 18, 2015. The NRC has decided to 
extend the public comment period on the draft ISG to allow more time 
for members of the public to review the supplemental information before 
submitting any comments.

III. Supplemental Information

    The NRC believes that the draft ISG, if issued in final form, would 
not constitute backfitting as defined in 10 CFR 70.76(a)(1). All fuel 
cycle facility licensees are required to conduct and maintain an ISA 
that analyzes the chemical hazards of licensed material. The 
performance requirements in 10 CFR 70.61(b) and (c) require that the 
risk of each credible high or intermediate consequence event be 
limited, and such events include those arising from an acute chemical 
exposure as specified in 10 CFR 70.61(b)(4) and (c)(4). For all 
credible event consequences as specified in 10 CFR 70.61(b)(4) and 
(c)(4), the ISA summary must describe the proposed quantitative 
standards used to address acute chemical exposures from credible event 
sequences in accordance with 10 CFR 70.65(b)(7). This requirement is 
reinforced by the ISA definition in 10 CFR 70.4. Subpart H of 10 CFR 
part 70 contains performance-based requirements under which the 
applicant/licensee must address all credible hazards, and there is no 
regulatory language limiting consideration of chemical hazards to 
specific exposure pathways. The draft ISG is consistent with the 
regulatory language in subpart H of 10 CFR part 70 and the NRC's 
position that the ISA should consider all acute chemical exposures, 
including dermal and ocular exposures.
    Since the initial NRC approval of ISA summaries, there have been a 
number of hazardous chemical exposure incidents involving dermal and 
ocular exposures at fuel cycle facilities. Two of these incidents of 
exposure have resulted in intermediate or high consequences. See Table 
1, Fuel Cycle Facility Dermal and Ocular Exposure Events Known to the 
NRC Staff. The NRC believes that these events demonstrate the need for 
fuel cycle facilities to address all exposure pathways when updating 
their safety programs, ISAs, and ISA summaries. The information 
contained in the draft ISG reflects and reiterates existing NRC 
regulatory requirements for the fuel cycle facility licensees who will 
be subject to the draft ISG. Therefore, issuance of the draft ISG in 
final form would not constitute backfitting. The NRC's positions on 
backfitting with respect to consideration of all exposure pathways (the 
subject of this draft ISG) are set forth in a September 15, 2014, 
letter to the Nuclear Energy Institute (NEI) (ADAMS Accession No. 
ML14251A150; Enclosure: ADAMS Accession No. ML14251A149). The NRC's 
September 2014 letter responds to a March 26, 2014, letter from NEI to 
the NRC (ADAMS Accession No. ML14086A267), which raises backfitting 
issues with respect to consideration of dermal and ocular exposures to 
hazardous chemicals at NRC-regulated fuel cycle facilities. The NEI 
also provided their views on backfitting with respect to consideration 
of dermal and ocular exposures to hazardous chemicals at NRC-regulated 
fuel cycle facilities in a November 7, 2014, letter to the General 
Counsel of the NRC (ADAMS Accession No. ML14322B019).
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    Dated at Rockville, Maryland, this 9th day of April 2015.

    For the Nuclear Regulatory Commission.
Craig G. Erlanger,
Deputy Director, Division of Fuel Cycle Safety, Safeguards, and 
Environmental Review, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2015-08932 Filed 4-16-15; 8:45 am]
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