[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Pages 22257-22260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08666]



[EPA-HQ-OAR-2007-0268; FRL-9707-2]

Updates to Protective Action Guides Manual: Protective Action 
Guides (PAGs) and Planning Guidance for Radiological Incidents

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability for interim use and public 


SUMMARY: As part of its mission to protect human health and the 
environment, the Environmental Protection Agency (EPA) publishes 
protective action guides to help federal, state, local and tribal 
emergency response officials make radiation protection decisions during 
emergencies. EPA, in coordination with a multi-agency working group 
within the Federal Radiological Preparedness Coordinating Committee 
(FRPCC), is proposing updates to the 1992 Manual of Protective Action 
Guides and Protective Actions for Nuclear Incidents, referred to as 
``The 1992 PAG Manual'' (EPA 400-R-92-001, May 1992).
    The updated guidance in this revised 2013 PAG Manual--Protective 
Action Guides and Planning Guidance for Radiological Incidents (``2013 
PAG Manual'' hereafter) applies the PAGs to incidents other than just 
nuclear power plant accidents, updates the radiation dosimetry and dose 
calculations based on current science and incorporates late phase 
    While there is no drinking water PAG provided in the proposal, the 
Agency continues to seek input on this. The newly proposed 2013 PAG 
Manual is available for interim use and review at www.regulations.gov.

DATES: Comments must be received on or before July 15, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0268, by one of the following methods--
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     Email: to [email protected]; Docket ID No. EPA-HQ-
     Fax: (202) 566-1741
     Mail: Air and Radiation Docket and Information Center, 
Environmental Protection Agency, Mail Code: 6102T, 1200 Pennsylvania 
Ave NW., Washington, DC 20460.
    Instructions: Direct your comments to Attn: Docket ID No. EPA-HQ-
OAR-2007-0268. The Agency's policy is that all comments received will 
be included in the public docket without change and may be made 
available online at www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through 
www.regulations.gov or email. The www.regulations.gov Web site is an 
``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an email comment directly to EPA without 
going through www.regulations.gov, your email address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you

[[Page 22258]]

include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
EPA has established a docket for this action under Docket ID No. [EPA-
HQ-OAR-2007-0268; FRL-9707-2]. Publicly available docket materials are 
available either electronically through www.regulations.gov or in hard 
copy at the Air and Radiation Docket in the EPA Docket Center, (EPA/DC) 
EPA West, Room 3334, 1301 Constitution Ave NW., Washington, DC 20004. 
The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744 and the 
telephone number for the Air and Radiation Docket is (202) 566-1742. In 
accordance with EPA's regulations at 40 CFR Part 2 and in accordance 
with normal EPA docket procedures, if copies of any docket materials 
are requested, a reasonable fee may be charged for photocopying.

FOR FURTHER INFORMATION CONTACT: Sara DeCair, Radiation Protection 
Division, Center for Radiological Emergency Management, Mail Code 
6608J, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue 
NW., Washington, DC 20460; telephone number: (202) 343-9108 ; fax 
number: (202) 343-2304; Email: [email protected].


A. What authority does EPA have to provide Protective Action Guidance?

    The historical and legal basis of EPA's role in the 2013 PAG Manual 
begins with Reorganization Plan No. 3 of 1970, in which the 
Administrator of EPA assumed all the functions of the Federal Radiation 
Council (FRC), including the charge to ``* * * advise the President 
with respect to radiation matters, directly or indirectly affecting 
health, including guidance for all federal agencies in the formulation 
of radiation standards and in the establishment and execution of 
programs of cooperation with states.'' (Reorg. Plan No. 3 of 1970, sec. 
2(a) (7), 6(a) (2); Sec.  274.h of the Atomic Energy Act of 1954, as 
amended (AEA), codified at 42 U.S.C. 2021(h)). Recognizing this role, 
FEMA directed EPA in their Radiological Emergency Planning and 
Preparedness Regulations to ``establish Protective Action Guides (PAGs) 
for all aspects of radiological emergency planning in coordination with 
appropriate federal agencies.'' (44 CFR 351.22(a)). FEMA also tasked 
EPA with preparing ``guidance for state and local governments on 
implementing PAGs, including recommendations on protective actions 
which can be taken to mitigate the potential radiation dose to the 
population.''(44 CFR 351.22(b)). All of this information was to ``be 
presented in the Environmental Protection Agency (EPA) `Manual of 
Protective Action Guides and Protective Actions for Nuclear 
Incidents.'''(44 CFR 351.22(b)).
    Additionally, section 2021(h) charged the Administrator with 
performing ``such other functions as the President may assign to him 
[or her] by Executive order.'' Executive Order 12656 states that the 
Administrator shall ``[d]evelop, for national security emergencies, 
guidance on acceptable emergency levels of nuclear radiation * * *.'' 
(Executive Order No. 12656, sec.1601(2)). EPA's role in PAGs 
development was reaffirmed by the National Response Framework, Nuclear/
Radiological Incident Annex of June 2008.

B. What is the PAG Manual: Protective Action Guides and Planning 
Guidance for Radiological Incidents?

    The 2013 PAG Manual provides federal, state and local emergency 
management officials with guidance for responding to radiological 
emergencies. A protective action guide (PAG) is the projected dose to 
an individual from a release of radioactive material at which a 
specific protective action to reduce or avoid that dose is recommended. 
Emergency management officials use PAGs for making decisions regarding 
actions to protect the public from exposure to radiation during an 
emergency. Such actions include, but are not limited to, evacuation, 
shelter-in-place, temporary relocation, and food restrictions.
    Development of the PAGs was based on the following essential 
principles, which also apply to the selection of any protective action 
during an incident--
     Prevent acute effects.
     Balance protection with other important factors and ensure 
that actions result in more benefit than harm.
     Reduce risk of chronic effects.
    The 2013 PAG Manual is not a legally binding regulation or standard 
and does not supersede any environmental laws; PAGs are not intended to 
define ``safe'' or ``unsafe'' levels of exposure or contamination. This 
guidance does not address or impact site cleanups occurring under other 
statutory authorities such as the United States Environmental 
Protection Agency's (EPA) Superfund program, the Nuclear Regulatory 
Commission's (NRC) decommissioning program, or other federal or state 
cleanup programs. As indicated by the use of non-mandatory language 
such as ``may,'' ``should'' and ``can,'' the 2013 Manual only provides 
recommendations and does not confer any legal rights or impose any 
legally binding requirements upon any member of the public, states, or 
any other federal agency. Rather, the 2013 PAG Manual recommends 
projected radiation doses at which specific actions may be warranted in 
order to reduce or avoid that dose. The 2013 PAG Manual is designed to 
provide flexibility to be more or less restrictive as deemed 
appropriate by decision makers based on the unique characteristics of 
the incident and the local situation.

C. What updates are in the 2013 PAG Manual?

    The draft updates to the 1992 PAG Manual were developed by a multi-
agency Subcommittee of the Federal Radiological Preparedness 
Coordinating Committee (FRPCC) and are published by EPA with 
concurrence from the Department of Energy (DOE); the Department of 
Defense (DoD); the Department of Homeland Security (DHS), including the 
Federal Emergency Management Agency (FEMA); the Nuclear Regulatory 
Commission; the Department of Health and Human Services (HHS), 
including both the Centers for Disease Control (CDC) and the Food and 
Drug Administration (FDA); the U.S. Department of Agriculture (USDA); 
and the Department of Labor (DOL).
    The 2013 PAG Manual focuses on the following key objectives--
     Clarify that the 1992 PAGs and protective actions are 
useful for all radiological and nuclear scenarios of concern, based 
both on the 1991 symposium, ``Implementation of Protective Actions for 
Radiological Incidents at Other Than Nuclear Power Reactors'' and the 
2008 interagency ``Planning Guidance for Protection and

[[Page 22259]]

Recovery Following Radiological Dispersal Device (RDD) and Improvised 
Nuclear Device (IND) Incidents.'' \1\

    \1\ Planning Guidance for Protection and Recovery Following 
Radiological Dispersal Device (RDD) and Improvised Nuclear Device 
(IND) Incidents, DHS/FEMA (73 FR 45029, Aug 1, 2008).

     Refer the reader to DOE's Federal Radiological Monitoring 
and Assessment Center (FRMAC) Assessment Manuals \2\ for calculation 
methods and measurable derived response levels (DRLs) and other 
appropriate dose assessment methods so that PAGs are implemented using 
the latest science.

    \2\ See: http://www.nv.doe.gov/nationalsecurity/homelandsecurity/frmac/manuals.aspx.

     Refer users to the current Food PAGs published in FDA's 
``Accidental Radioactive Contamination of Human Food and Animal Feeds: 
Recommendations for State and Local Agencies,'' as issued in 1998.\3\

    \3\ Accidental Radioactive Contamination of Human Food and 
Animal Feeds: Recommendations for State and Local Agencies, FDA (63 
FR 43402, Aug 13, 1998).

     Recommend a simplified PAG approach for administering 
potassium iodide (KI) as a supplementary protective action based on FDA 
guidance issued in 2001.\4\

    \4\ Guidance: Potassium Iodide as a Thyroid Blocking Agent in 
Radiation Emergencies, FDA (66 FR 64046, Dec. 11, 2001).

     Provide basic planning guidance on reentry, cleanup and 
waste disposal.
     Substantively incorporate the 2008 ``Planning Guidance for 
Protection and Recovery Following Radiological Dispersal Device (RDD) 
and Improvised Nuclear Device (IND) Incidents'' particularly for late 
phase cleanup after a nationally significant radiological incident, 
like a disaster at a NPP, an RDD or an IND. The 2008 RDD-IND Planning 
Guidance will remain in effect until the PAG Manual, with public 
comments incorporated, is finalized for use.
     Streamline the Manual to enhance usability, while 
retaining the 1992 PAG Manual in its entirety as a historical online 

D. What should I consider as I prepare my comments for EPA?

1. Submitting Confidential Business Information (CBI)

    Do not submit this information to EPA through www.regulations.gov 
or email. Clearly mark all of the information that you claim to be CBI. 
For CBI information in a disk or CD ROM that you mail to EPA, mark the 
outside of the disk or CD ROM as CBI and then identify electronically 
within the disk or CD ROM the specific information that is claimed as 
CBI. In addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information marked as CBI will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2.

2. Tips for Preparing Your Comments

    When submitting comments, remember to--
     Identify the rulemaking by docket number, subject heading, 
Federal Register date and page number.
     Follow directions--EPA may ask you to respond to specific 
questions or organize comments by referencing the chapter number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow it to be 
     Illustrate your concerns with specific examples and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.

E. What specific comments are being sought?

    While all comments regarding any aspect of the 2013 PAG Manual are 
welcome, comments on the following issues are specifically requested--
    Issues across the scope of the entire 2013 PAG Manual:
     To implement the PAGs, the reader is referred to dose 
calculations in the Federal Radiological Monitoring and Assessment 
Center (FRMAC) Assessment Manuals. The Assessment Manuals are updated 
with current International Commission on Radiological Protection (ICRP) 
dosimetry models (i.e., ICRP 60 series) and dose coefficients. The 
FRPCC also encourages the use of computational tools such as DOE's 
Turbo FRMAC, RESRAD RDD and NRC's RASCAL or other appropriate tools and 
methods to implement the PAGs. We request comment on the usefulness of 
this approach and seek feedback on how to facilitate implementation of 
these methods in emergency management plans.
     The Agency recognizes a short-term emergency drinking 
water guide may be useful for public health protection in light of the 
Fukushima nuclear power plant accident, which impacted some Japanese 
drinking water supplies. Input on the appropriateness of, and possible 
values for, a drinking water PAG is being sought.
     FDA's 1998 food guidance is incorporated by reference. 
Since it is already final and published, comments are not requested on 
the Food PAGs.
    Chapter 2--Early Phase:
     The most substantive PAG change in the Early Phase is the 
2001 guidance from the FDA that lowers the threshold for administration 
of potassium iodide (KI) to the public from 25 rem projected adult 
thyroid dose to 5 rem projected child thyroid dose. Chapter 2 includes 
a streamlined implementation scheme based on FDA's guidance. Please 
comment on the usefulness of this simplified guidance in the text of 
Chapter 2.
     The skin and thyroid evacuation thresholds were removed to 
avoid confusion with the KI threshold. The skin and thyroid doses were 
5 and 50 times higher, respectively, than the 1 to 5 rem whole-body 
dose guideline. Please comment specifically on the appropriateness of 
not retaining the skin and thyroid evacuation thresholds.
    Chapter 3--Intermediate Phase:
     The most substantive PAG change in the Intermediate Phase 
is the removal of the 5 rem over 50 years relocation PAG which was 
potentially being confused with long term cleanup. Please comment on 
the appropriateness of this change.
     As an extension of the PAGs, new guidance on reentry to 
relocation areas is provided to inform plans and procedures to protect 
workers and members of the public as the Intermediate Phase progresses. 
Please comment on the format and utility of this material.
     Please comment on whether it would be useful to develop a 
new, combined Intermediate Phase PAG considering all exposure pathways 
to potentially simplify decision making.
    Chapter 4--Late Phase:
     A brief planning guidance on the cleanup process is 
included. Please comment on the usefulness of this information, as well 
as how it might best be implemented in state, tribal and local plans. 
It should be noted that the extent and scope of contamination as a 
result of an NPP, RDD or IND incident may be at a much larger scale 
than a site or facility decommissioning or remedial cleanup normally 
experienced under established regulatory frameworks.

[[Page 22260]]

Lesser radiological incidents may be well addressed under existing 
emergency response and environmental cleanup programs.
     A suggested process and organization for approaching the 
late phase cleanup is provided from the 2008 RDD-IND Planning Guidance. 
Please comment on the merging of that guidance with the 2013 PAG 
     Basic planning guidance on approaching radioactive waste 
disposal is included. Please comment on this material and how it should 
be implemented in emergency response and recovery plans at all levels 
of government.
    After considering public comments as appropriate, EPA intends to 
issue a final PAG Manual which will supersede the 1992 PAG Manual and 
the 2008 RDD-IND Planning Guidance.

    Dated: April 5, 2013.
Bob Perciasepe,
Acting Administrator.
[FR Doc. 2013-08666 Filed 4-12-13; 8:45 am]