[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6498-6500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01230]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0268; FRL-9958-50-OW]


Revision to the PAG Manual: Protective Action Guide (PAG) for 
Drinking Water After a Radiological Incident

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: As part of its mission to protect human health and the 
environment, the Environmental Protection Agency publishes protective 
action guides (PAGs) 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, 
recently updated its guidance manual on this topic, titled ``Protective 
Action Guides and Planning Guidance for Radiological Incidents'' 
(referred to herein as the PAG Manual). On December 8, 2016, EPA 
announced availability of the updated 2016 PAG Manual in the Federal 
Register. In this document, EPA is announcing that it has amended 
Chapter 4 of the 2016 PAG Manual to incorporate guidance for radiation 
protection decisions concerning drinking water. The drinking water PAG 
is not binding and does not in any way affect regulatory requirements 
or enforcement of the Safe Drinking Water Act (SDWA), including maximum 
contaminant limits (MCLs) for radionuclides established by regulation 
under the SDWA. The drinking water PAG is guidance only and is intended 
for use by federal, state and local emergency management officials in 
the unlikely event of significant radiological contamination incidents, 
such as a disaster at a nuclear power plant, a radiological dispersal 
device or an improvised nuclear device, and for a duration which may 
last for weeks to months but not longer than one year. The dose levels 
reflected in the drinking water PAG provide a level of protection 
against cancer risks for a short-term (weeks to months but not longer 
than a year), similar to that provided by EPA's MCLs for radionuclides 
(which are calculated based on 70 years of exposure). The revised 
drinking water PAG is available for use upon publication of this 
document in the Federal Register, at www.regulations.gov, under ID No. 
EPA-HQ-OAR-2007-0268.

FOR FURTHER INFORMATION CONTACT: Samuel Hernandez, 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) 564-1735; 
email: [email protected].

SUPPLEMENTARY INFORMATION: 

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

    Docket: EPA has established a docket for this action under Docket 
ID No. EPA-HQ-OAR-2007-0268. 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 Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Docket's 
Public Reading Room is (202) 566-1744 and the telephone number for the 
Air and Radiation Docket is (202) 566-1742. 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 site at http://www.epa.gov/radiation/protective-action-guides-pags.

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

    The historical and legal basis of EPA's role in the PAG Manual 
begins with the 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, section 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, section 1601(2)). EPA's role in PAGs 
development was recognized 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 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:

[[Page 6499]]

     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 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 other 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 proposed Draft 
Protective Action Guide for Drinking Water?

    PAGs do not represent ``acceptable'' routine exposure in the way 
that regulatory standards such as maximum contaminant levels do. PAGs 
are guidance levels to support emergency decision making by response 
authorities to avoid unnecessary radiation exposure. Development and 
implementation of PAGs is always guided by three basic 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.
    On June 10, 2016, EPA published a Federal Register document 
requesting public comments on the proposed drinking water PAG and the 
guidance for advance planning (81 FR 37589). EPA sought specific 
comments and feedback on the appropriateness of the drinking water PAG 
and possible implementation challenges associated with the two-tiered 
approach. In addition, EPA asked whether a single-tier drinking water 
PAG should be considered rather than using the tiered approach.
    In response, EPA received over 60,000 comment letters from members 
of the public, state and local emergency response and health 
organizations, environmental advocates, industry associations and other 
stakeholders. Most of the comment letters expressed concerns with the 
proposed guidance. Commenters wrote that the proposed guidance could 
weaken the regulatory requirements of the Safe Drinking Water Act. In 
addition, environmental advocacy organizations indicated that the 
drinking water PAG dose levels were too high and insufficient to be 
protective of human health, and asked EPA to withdraw the proposed 
guidance and, in its place, use the National Primary Drinking Water 
Regulations for Radionuclides as the basis for any emergency response 
measures regarding drinking water.
    Commenters also asserted that the proposed drinking water PAG did 
not conform to the National Environmental Policy Act (NEPA) as well as 
other regulations dealing with cleanup and waste management of 
radioactive contaminants. Commenters expressed doubts regarding the 
duration that the drinking water PAG would be implemented after an 
incident, claiming that the drinking water PAG could be in place for 
timeframes exceeding one year.
    In response to comments, EPA has amended the drinking water 
guidance to emphasize, with regards to the scope of the drinking water 
PAG recommendations, that they are only intended to apply to nationally 
significant radiological contamination incidents, such as a disaster at 
a nuclear power plant, a radiological dispersal device or an improvised 
nuclear device, and for a duration that may last for weeks to months 
but not longer than one year.
    Some commenters expressed concerns that PAGs would weaken drinking 
water standards and regulations. Environmental regulations or standards 
are legal limits designed to minimize 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. The PAG levels trigger public 
safety measures to minimize radiation exposures during an emergency.
    To develop guidance on drinking water considerations, EPA based its 
assessment on assumptions limiting exposures to a one-year timeframe. 
EPA expects that the responsible party for 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.
    The National Primary Drinking Water Regulations establish 
regulatory limits designed to minimize health effects from everyday 
exposure to low levels of radiation over long periods; those limits are 
not changing with this action. Emergency guides are temporary measures 
to minimize risk while enabling distribution of limited resources 
during an emergency response.
    Estimated risk of excess cancer cases for lifetime exposure (70 
years) to beta emitting radioactive contaminants in drinking water at 4 
mrem/yr (the MCL) generally falls in a range of risks deemed acceptable 
by EPA. Estimated risks associated for a shorter (one-year) exposure to 
radioactivity in drinking water at the proposed PAG levels fall within 
a similar risk range.
    The drinking water PAG meets NEPA policy goals because it is based 
on analyses, documentation and review procedures that are functionally 
equivalent to NEPA. ``Activities for the development of federal 
radiation regulations and guidance in accordance with the Atomic Energy 
Act of 1954 are functionally equivalent to NEPA'' (63 FR 58045, October 
29, 1998).
    Commenters questioned whether the EPA considered cumulative effects 
in developing the drinking water PAG. In developing the PAG Manual, EPA 
considered the potential for cumulative exposure from multiple exposure 
pathways including: plume inhalation, immersion, ground shine, drinking 
water ingestions and food, among others. However, EPA has determined 
that for implementation purposes, it is impractical to compartmentalize 
joint protective actions, since allocations of dose to different 
segments of the population based on individual exposure routes will 
depend on site-specific circumstances and are impossible to quantify. 
While the PAGs for the various pathways are separate, emergency 
management officials should consider all relevant exposure routes when 
making protective action decisions in an emergency. In addition, 
incident-specific factors like geographical location, ongoing weather, 
the isotopes released and population affected should be considered 
after a contamination event, and specific exposure routes should be 
identified to allow different types of protective actions to be aimed 
at the specific risks to be avoided.

[[Page 6500]]

    Several commenters from state emergency management agencies and 
radiation control programs expressed support for EPA's proposal, 
stating that the guidance was well developed and technically sound; and 
that the incorporation of the drinking water PAG into the PAG Manual is 
a critical aspect of a coordinated emergency response after a radiation 
contamination incident.
    Some commenters suggested that while they support the incorporation 
of the drinking water PAG, they believe the proposed PAG was too 
conservative and that EPA should consider establishing the PAG in the 
2,000 to 10,000 mrem range.
    EPA believes that the drinking water PAG should be consistent with 
and within the range of currently available guidance for other exposure 
pathways during the intermediate phase. Also, when possible, the 
drinking water PAG recommendations should be based on an additional 
level of protection to sensitive life-stages. For short-term incidents, 
as explained in the PAG Manual, it is appropriate to have a 500 mrem 
PAG level for drinking water for the general population and a lower-
tier PAG level of 100 mrem for persons at 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 abundance of caution built into the derivation of the 
drinking water PAG through a variety of assumptions, including 
conservative dose-response modeling; selection of the most sensitive 
life stages to derive the PAG for children through age 15 years; and, 
the assumption of no decay of isotopes over the calculated one-year 
exposure period, which may be appropriate in some situations. This 
action ensures that the protective measures it recommends are 
appropriate for all members of the public, including sensitive 
subpopulations.

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 the update of plans and procedures. Outreach and technical 
training will be conducted by EPA, the Federal Radiological Monitoring 
and Assessment Center and interagency partners of the PAG Subcommittee. 
FEMA expects certain organizations associated with nuclear power plant 
operations to use the PAG Manual in developing their emergency 
management plans. FEMA plans to begin using the new PAG Manual during 
their evaluation of offsite response organizations around nuclear power 
facilities 12 months after the publication of this document in the 
Federal Register.
    For further information and related guidelines, see the EPA Web 
site: http://www.epa.gov/radiation/protective-action-guides-pags. 
Keywords include: drinking water, radiation, radiological incident, 
emergency and protective action guide.

    Dated: January 10, 2017.
Joel Beauvais,
Deputy Assistant Administrator, Office of Water.
[FR Doc. 2017-01230 Filed 1-18-17; 8:45 am]
 BILLING CODE 6560-50-P