
[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Notices]
[Pages 88679-88681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29439]



[[Page 88679]]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0268; FRL-9956-19-OAR]


Final Revision to the PAG Manual: Protective Action Guides and 
Planning Guidance for Radiological Incidents

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability.

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

SUMMARY: As part of its mission to protect human health and the 
environment, the U.S. Environmental Protection Agency (EPA) publishes 
protective action guides to help federal, state, local and tribal 
emergency response officials make radiation protection decisions during 
emergencies. The EPA, in coordination with a multi-agency working group 
within the Federal Radiological Preparedness Coordinating Committee 
(FRPCC), has made final 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 the revised PAG Manual: Protective Action 
Guides and Planning Guidance for Radiological Incidents (``PAG Manual'' 
hereafter) applies the protective action guides (PAGs) to incidents 
other than nuclear power plant accidents, updates the radiation 
dosimetry and dose calculations based on current science and 
incorporates late phase guidance. The final revisions incorporate input 
from public comments received in 2013 and include clarifications based 
on those comments. The Agency plans to finalize drinking water guidance 
after incorporating public comments on a proposal published in June 
2016. The intention is to add it as a section in the Intermediate Phase 
chapter of the PAG Manual and reissue the PAG Manual once complete. The 
final revision of the PAG Manual is available at www.regulations.gov.

DATES: The PAG Manual is available for use upon publication of this 
Notice in the Federal Register.

FOR FURTHER INFORMATION CONTACT: Sara DeCair, Radiation Protection 
Division, Center for Radiological Emergency Management, Mail Code 
6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue 
NW., Washington, DC 20460; telephone number: (202) 343-9108; fax 
number: (202) 343-2304; Email: decair.sara@epa.gov.

SUPPLEMENTARY INFORMATION: 

A. How can I get copies of the PAG Manual and supporting information?

    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. 
The EPA has established a docket for this action under Docket ID No. 
[EPA-HQ-OAR-2008-0268; 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 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.
    Electronic access: The PAG Manual in electronic form suitable for 
printing, as well as related guidelines and further information, can be 
found on the PAGs Web page at http://www.epa.gov/radiation/protective-action-guides-pags.

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

    The historical and legal basis of the EPA's role in the PAG Manual 
begins with Reorganization Plan No. 3 of 1970, in which the 
Administrator of the EPA assumed 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, 
the Federal Emergency Management Agency (FEMA) directed the 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 the 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)). The EPA's role in PAGs 
development was reaffirmed by the National Response Framework, Nuclear/
Radiological Incident Annex of June 2008.

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

    The 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 PAG Manual is not a legally binding regulation or standard and 
does not supersede any environmental laws. This guidance does not 
address or impact site cleanups occurring under other statutory 
authorities such as the EPA's 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

[[Page 88680]]

language such as ``may,'' ``should'' and ``can,'' the PAG 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 federal agency. Rather, the PAG Manual recommends projected 
radiation doses at which specific actions may be warranted in order to 
reduce or avoid that dose. The 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.

D. How did EPA respond to public comments on the 2013 PAG Manual 
revision?

    The proposed updates to the 1992 PAG Manual, published for public 
comment and interim use in 2013, were developed by a multi-agency 
Subcommittee of the Federal Radiological Preparedness Coordinating 
Committee (FRPCC) and published by the 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 (NRC); 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 Agency received about 5,000 comments from members of the 
public, state and local emergency response and health organizations, 
industry associations, and from national and international radiation 
protection organizations. In response to comments received, questions 
raised in comments and issues identified about implementing the updated 
PAG Manual, the EPA made a number of changes to the PAG Manual, as 
described below.
    The EPA received comments and questions on the potassium iodide 
(KI) PAG from state radiation protection agencies and from industry 
organizations. In response, planning considerations were clarified 
regarding the lower FDA KI PAG in combination with deleting the 
thyroid-based evacuation threshold. The EPA added a Table (Table 2.2) 
with more details on the KI PAG; and also worked with the FDA to 
include a simplified approach to implementing this PAG and provided 
reference for the reader to the FDA's published guide. More explanation 
was included regarding the thyroid-based (organ-based) evacuation 
thresholds being deleted. This was done for simplicity and because 
modern dose projection tools now do a much better job of accounting for 
all-pathway exposures.
    The EPA received many comments from PAG technical users suggesting 
terminology improvements and requesting more information about how the 
Federal Radiological Monitoring and Assessment Center (FRMAC)--the 
federal government lead for these calculations during radiological 
emergencies--provides calculation methods and tables of derived levels. 
Additional language is provided on the tables of derived values for 
implementing the PAGs. Specifically, clarifying text on FRMAC methods 
and dose factor terminology was added. Definitions for incident phases 
and several concepts around dose projection were also clarified.
    The Agency received comments from state emergency management and 
radiation protection agencies, as well as federal agencies, requesting 
the inclusion of language from the 1992 PAG Manual Appendices in the 
revised PAG Manual. This text, focusing on the rationale and basis for 
setting early and intermediate phase PAGs, has been added to the 
revised PAG Manual. The 2013 proposal included this information only by 
reference, but the revised PAG Manual will serve the emergency response 
community better by providing a summarized description of the basis for 
setting PAGs directly in the new publication. The 1992 PAG Manual 
Appendices are still available online in a word-searchable format, for 
reference.
    The EPA received limited, but important, comments on the worker 
protection section of the proposed Manual, requesting updates to 
reflect more recent publications on worker safety. These comments were 
considered by the EPA, the Occupational Safety and Health 
Administration and the NRC; changes were made to ensure consistency 
with the latest worker safety guidelines from other agencies.
    Some commenters expressed concern over the removal of the 5 rem 
over 50 years Relocation PAG. Therefore, explanation about the removal 
of that PAG was expanded, adding language to better explain the 
deletion. The decision was made in order to eliminate confusion with 
long-term remediation timeframes and long-term cleanup goals.
    The EPA received a number of comments, largely from environmental 
organizations, expressing concern about whether the PAGs are safe 
enough, and whether children and sensitive subpopulations are 
considered adequately. There is an abundant conservatism built into the 
derivation of the PAGs, and into the assumptions used to generate 
derived response levels, to ensure that the PAGs are appropriate 
emergency guides for all members of the public, including sensitive 
subpopulations. The Agency provided additional explanation in the 
revised Manual about the basis for the PAGs and how PAG levels are set. 
A discussion of the conservatism that has been built into the early and 
intermediate phase PAGs was also added to the Manual.
    Some commenters expressed concerns that PAGs would weaken 
environmental standards and regulations. Environmental regulations or 
standards are legal limits designed to prevent health effects from 
everyday exposure to low levels of radiation over long periods. The PAG 
levels are guidance for emergency situations; they do not supplant any 
standards or regulations, nor do they affect the stringency or 
enforcement of any standards or regulations. The PAG levels are 
intended to be used only in an emergency when radiation levels have 
already exceeded environmental standards and could be high enough to 
cause health effects unless protective actions are taken. The PAG 
levels trigger public safety measures to minimize or avoid radiation 
exposures during an emergency.
    The EPA also received some comments suggesting that the U.S. should 
rely solely on existing environmental standards and that PAGs are not 
needed. PAG levels do not replace environmental standards, and 
environmental standards do not fulfill the role of the PAGs. PAGs are 
used only during emergency situations when radiation levels are already 
exceeding environmental standards and could become high enough to cause 
adverse health effects unless protective action is taken. During a 
radiological emergency, the PAGs are designed to prevent adverse health 
effects by triggering public safety measures--protective actions, such 
as evacuation--and minimizing unnecessary exposures. The PAGs are set 
at a level where the health risk from radiation exposure that could be 
avoided with protective action outweighs the risk associated with 
taking the safety measures, e.g., traffic accidents, trips and falls or 
anxiety associated with dislocation or the separation of family 
members.
    Finally, the EPA received comments requesting edits to clarify, 
reword or reorder language in the PAG Manual. Based on those comments, 
a number of

[[Page 88681]]

editorial changes were made to improve both the clarity and readability 
of the Manual.

E. What is the timeframe for implementation of this PAG Manual?

    Emergency management and radiation protection organizations that 
use the PAGs in their emergency plans are encouraged to incorporate 
this updated guidance as soon as possible. This may entail training, as 
well as updating plans and procedures. Outreach and technical training 
will be conducted by the EPA, the FRMAC and interagency partners on the 
PAG Subcommittee.
    The Federal Emergency Management Agency (FEMA) expects certain 
organizations associated with nuclear power plant operations to use the 
PAG Manual in developing their emergency management plans. The FEMA 
plans to begin using the new PAG Manual during their evaluation of 
offsite response organizations around nuclear power facilities twelve 
months after the publication of this Notice in the Federal Register.
    For further information and related guidelines, see the PAGs Web 
page: http://www.epa.gov/radiation/protective-action-guides-pags.

    Dated: December 1, 2016.
Gina McCarthy,
Administrator.
[FR Doc. 2016-29439 Filed 12-7-16; 8:45 am]
 BILLING CODE 6560-50-P


