
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37589-37592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13786]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0268; FRL-9947-55-OW]


Notice of Availability: Draft Protective Action Guide (PAG) for 
Drinking Water After a Radiological Incident

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of document availability; request for public comment.

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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, is 
proposing an addition to the 2013 revised interim Protective Action 
Guides and Planning Guidance for Radiological Incidents (``2013 revised 
PAG Manual'' hereafter) to provide guidance on drinking water. The 
Draft Protective Action Guide for Drinking Water is now available in 
the EPA Docket, under ID No. EPA-HQ-OAR-2007-0268, and EPA is 
requesting comment on the draft guide.

DATES: Comments must be received on or before July 25, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0268, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting 
comments. Once submitted, comments cannot be edited or withdrawn. The 
EPA may publish any comment received to its public docket. Do not 
submit electronically any information you consider to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Multimedia submissions (audio, video, etc.) must 
be accompanied by a written

[[Page 37590]]

comment. The written comment is considered the official comment and 
should include discussion of all points you wish to make. The EPA will 
generally not consider comments or comment contents located outside of 
the primary submission (i.e. on the web, cloud, or other file sharing 
system). For additional submission methods, the full EPA public comment 
policy, information about CBI or multimedia submissions, and general 
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Lisa M. Christ, Standards and Risk 
Management Division, Office of Ground Water and Drinking Water, Mail 
Code 4607M, U.S. Environmental Protection Agency, 1200 Pennsylvania 
Avenue NW., Washington, DC 20460; telephone number: (202) 564-8354; fax 
number: (202) 564-3758; Email: christ.lisa@epa.gov.

SUPPLEMENTARY INFORMATION: 

1. General Information

A. Does this action apply to me?

    This action does not impose any requirements on anyone. It notifies 
interested parties of EPA's proposed, draft drinking water protective 
action guide (PAG) and requests public comment. The drinking water PAG 
will help federal, state, local, tribal officials and public water 
systems make decisions about use of water during radiological 
emergencies. The drinking water PAG is non-regulatory guidance.

B. 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 the 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 [s]tates.'' (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 EPA, 
in its 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.

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

    In 2013, EPA revised the PAG Manual to provide federal, state and 
local emergency management officials with guidance for responding to 
radiological emergencies (78 FR 22257, April 15, 2013). See the 2013 
PAG Manual at https://www.epa.gov/radiation/protective-action-guides-pags. 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 evacuation, shelter-in-place, temporary 
relocation, water and food restrictions.
    The PAGs are 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; PAGs are not intended to 
define ``safe'' or ``unsafe'' levels of exposure or contamination. As 
indicated by the use of non-mandatory language such as ``may,'' 
``should'' and ``can,'' the 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 provides projected radiation dose levels 
at which specific actions are recommended in order to reduce or avoid 
that dose. The 2013 revised interim 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. What additional guidance is being proposed for the PAG Manual?

    The draft drinking water protective action guidance was developed 
by a multi-agency PAG Subcommittee of the Federal Radiological 
Preparedness Coordinating Committee and is published by the EPA with 
concurrence from the Department of Energy, the Department of Defense, 
the Department of Homeland Security (DHS), including the Federal 
Emergency Management Agency, the Nuclear Regulatory Commission, the 
Department of Health and Human Services, including both the Centers for 
Disease Control and Prevention and the Food and Drug Administration 
(FDA), the U.S. Department of Agriculture and the Department of Labor.
    A large scale radiation contamination incident could impact the 
United States, driving the need for a pre-established drinking water 
PAG. EPA is proposing a two-tiered intermediate phase drinking water 
PAG of 100 mrem projected dose in the first year for infants, children 
and pregnant or nursing women and 500 mrem projected dose in the first 
year for the general population. The proposed PAG is designed to work 
in concert with the other Protective Action Guides currently in place 
for other media in the intermediate phase (i.e., the Food and Drug 
Administration's 500 mrem PAG for ingestion of food) and provides an 
additional level of protection for the most sensitive life stages. 
Authorities have flexibility on how to apply the PAG. In some cases 
they may find it prudent to use a single PAG (e.g., 100 mrem) as a 
target for the whole population, while in other circumstances, 
authorities may find that it makes sense to use both targets 
simultaneously. For example, emergency managers can use a two-tiered 
approach to focus on protecting the most sensitive population with 
limited, alternate water resources. Because the water and food PAGs are

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designed to be used in concert, the appropriate protective actions will 
be influenced by the exposure scenario and factors that influence the 
viability of alternative approaches to reducing that dose.
    This proposed, additional draft guidance recommends protective 
actions when drinking water may be impacted by a radiological or 
nuclear incident. The two-tier approach seeks to balance the goal of 
keeping radiation doses as low as possible with the practical and 
logistical challenges of providing alternative drinking water during 
the response to a disaster. EPA has included examples of estimated 
costs for selected drinking water protective actions in the Docket, ID 
No. EPA-HQ-OAR-2007-0268. In developing the drinking water PAG, the 
Agency considered potential cumulative exposure from a radiation 
incident. Ultimately, a PAG does not represent an ``acceptable'' 
routine exposure; a PAG is a dose at which protective action is advised 
in order to reduce or avoid that dose. Every PAG is developed with the 
same three principles: prevent acute effects, balance protection with 
other important factors and ensure that actions result in more benefit 
than harm, and reduce risk of chronic effects. Emergency management 
officials should consider all exposure routes when making protective 
action decisions in an emergency.
    Under the Safe Drinking Water Act (SDWA), the Agency has 
established maximum contaminant levels (MCLs) for radiological 
contaminants in drinking water. The National Primary Drinking Water 
Regulations (NPDWR) for radionuclides are based on lifetime exposure 
criteria and assume 70 years of continued exposure to contaminants in 
drinking water. While the SDWA framework is appropriate for day-to-day 
normal operations, it may not provide the necessary tools to assist 
emergency responders with determining the need for an immediate 
protective action. EPA expects that any drinking water system adversely 
impacted during a radiation contamination incident will take action to 
return to compliance with MCLs as soon as practicable.

E. How were comments received on the 2013 draft PAG Manual considered 
in developing this proposal?

    On April 15, 2013, EPA published a Federal Register notice 
requesting public comments on the appropriateness of developing and 
incorporating a drinking water PAG in the revised PAG Manual (78 FR 
22257).
    Regarding the specific issue of drinking water, the Agency received 
about 50 comment letters from members of the public, state and local 
emergency response and health organizations, environmental advocates, 
industry associations, organizations opposed to nuclear power, and from 
national and international radiation protection organizations.
    Several commenters from state emergency management agencies and 
radiation control programs expressed an urgent need for EPA to 
establish a drinking water PAG, pointing out that drinking water is the 
only media not currently addressed in the PAG Manual. Commenters stated 
that a drinking water PAG is a critical aspect of a coordinated 
emergency response after a radiation contamination incident.
    Commenters representing states agencies from Ohio, Kansas, 
Pennsylvania, Illinois and Washington suggested that a drinking water 
PAG should be established at the 500 mrem level, to be consistent with 
the FDA food PAG and with the DHS guidance \1\ for water. While EPA 
agrees with the need of establishing a drinking water PAG, which is 
consistent with currently available guidance, it is also important to 
note that EPA believes that when possible, PAG recommendations should 
provide an additional level of protection to sensitive life-stages. For 
short-term incidents, it is appropriate to consider a lower tier PAG 
level of 100 mrem for sensitive life-stages including pregnant women, 
nursing women and children 15 years old and under. This approach of 
setting a two-tier level of protection incorporates suggestions 
submitted by commenters regarding the adequate consideration of 
children and sensitive subpopulations. There is an abundant precaution 
built into the derivation of the drinking water PAG through a variety 
of assumptions, including amount of water consumed, exposure duration 
and dose-response modeling, using the dose-response for the most 
sensitive life stages to derive the PAG for children through age 15 
years. Today's proposal ensures that protective measures are 
appropriate for all members of the public, including sensitive 
subpopulations.
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    \1\ Guidance established by the Department of Homeland Security 
as an intermediate-level PAG for drinking water interdiction (73 FR 
45029, April 1, 2008).
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    In contrast, several commenters from environmental protection 
advocate organizations suggested that a drinking water PAG is not 
needed, and urged EPA to base any emergency response measures regarding 
drinking water solely on the NPDWR for Radionuclides MCLs. Some 
commenters expressed concerns that establishing a drinking water PAG 
would weaken existing environmental standards and regulations. However, 
the drinking water standards are legal limits designed to prevent 
health effects from everyday exposure to low levels of radiation over 
long periods and they are not changing with this proposal.
    Estimated risk of excess cancer cases for lifetime exposure (70 
years) to radioactive contaminants in drinking water at 4 mrem/yr (the 
MCL) generally falls in a range of risks deemed acceptable by the 
Agency's regulations. Estimated risks associated with a shorter (one 
year) exposure to radioactivity in drinking water at the proposed PAG 
levels fall within a similar range. Emergency guides are temporary 
measures to minimize risk while enabling prioritization of limited 
resources during an emergency response.
    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. EPA expects that 
any drinking water system adversely impacted during a radiation 
incident will take action to return to compliance with Safe Drinking 
Water Act levels as soon as practicable.

F. When will the PAG Manual be finalized?

    Once comments on this proposed, additional draft action have been 
addressed, EPA will add drinking water guidance to the full PAG Manual, 
which will then be issued in final form for incorporation into state, 
local, tribal and federal emergency response plans over a one-year 
implementation timeframe.

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

    When submitting comments, remember to:
     Identify the rulemaking by docket number, subject heading, 
Federal Register date and page number.
     Follow directions--the EPA may ask you to respond to 
specific questions or organize comments by referencing the chapter 
number of the draft action guide
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide technical information 
and data that you used.

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     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow it to be 
reproduced.
     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.

H. What specific comments are being sought?

    While all comments regarding any aspect of the draft drinking water 
PAG guidance will be considered, please comment on the following issues 
specifically:
     Please comment on the appropriateness of the drinking 
water PAG and the guidance for advance planning.
     Please comment on what implementation challenges might be 
associated with the two-tiered approach to the water PAG that EPA 
should consider, and suggest additional guidance that would be helpful.
     Please comment on whether (and if so why) EPA should 
reconsider using a single-tier drinking water PAG rather than tiered 
approach proposed in the draft action guide.
     Please suggest additional guidance that would aid pre-
incident planning and implementation specific to your community's 
drinking water systems.
     Please comment on how this guidance should be implemented 
in emergency response and recovery plans at all levels of government, 
including considerations for public communications during an emergency.
    In the future, calculations and derived response levels will be 
provided in the Federal Radiological Monitoring and Assessment Center 
(FRMAC) Assessment Manuals. Emergency planners are referred to FRMAC 
Monitoring and Sampling Methods to assess surface and drinking water 
impacts from a radiological emergency. See the Assessment and 
Monitoring & Sampling folders at http://www.nv.doe.gov/nationalsecurity/homelandsecurity/frmac/manuals.aspx. After considering 
public comments, EPA intends to issue a final PAG Manual, which will 
supersede the 1992 PAG Manual and the 2013 revised PAG Manual.

    Dated: June 3, 2016.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2016-13786 Filed 6-9-16; 8:45 am]
 BILLING CODE 6560-50-P


