Federal Register / Vol. 76, No. 104 / Tuesday, May 31, 2011 / Notices 31329 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OAR–2011–0436; FRL–9313–4] 

EPA Radiogenic Cancer Risk Models 

and Projections for the U.S. Population 

(Blue Book) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This document announces the 

availability of U.S. Environmental 

Protection Agency’s (EPA) updated EPA 

Radiogenic Cancer Risk Models and 

Projections for the U.S. Population (EPA 

402–R–11–001, April 2011), also known 

as the Blue Book, which provides 

radiation risk assessment methodology. 

EPA will use the scientific information 

on radiation risks provided in the Blue 

Book, together with information from 

other sources, when considering 

potential modifications and updates to 

radiation protection rules and guidance. 

FOR FURTHER INFORMATION CONTACT: 

David Pawel, Radiation Protection 

Division (6608J), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington DC 20460; 

telephone number: 202–343–9202; fax 

number: 202–343–2302; e-mail address: 

pawel.david@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. How can i get copies of this 

document and other related 

information? 

1. Docket. EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2011–0436; FRL– 

9313–4]. Publicly available docket 

materials are available either 

electronically through http:// 

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. 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. 

As provided in 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. 

2. Electronic Access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. 

II. Background 

The U.S. Environmental Protection 

Agency develops estimates of risk from 

low-level ionizing radiation as part of its 

responsibilities for regulating 

environmental exposures and in its role 

of providing Federal Guidance on 

radiation protection. 

The EPA Radiogenic Cancer Risk 

Models and Projections for the U.S. 

Population, also known as the Blue 

Book, is a revision to EPA’s 

methodology for estimating radiogenic 

cancer risks. These updates are based on 

the National Research Council’s latest 

report on Biological Effects of Ionizing 

Radiation (BEIR VII) as well as other 

updated science. 

The Blue Book uses the best science 

available to calculate cancer risk 

estimates separately by age at exposure, 

sex, and potentially affected organ. 

More specifically, the Blue Book 

presents new EPA estimates of cancer 

incidence and mortality risk coefficients 

pertaining to low dose exposures to 

ionizing radiation for the U.S. 

population, as well as their scientific 

basis. (Risk here refers to the probability 

of a health effect, i.e., a cancer or a 

cancer death; a risk coefficient refers to 

the risk per unit dose of ionizing 

radiation.) 

The Blue Book has undergone an 

extensive peer review process. It takes 

into account recommendations made by 

the Agency’s Science Advisory Board 

(SAB), which completed its review in 

January 2010. For the Blue Book review, 

the SAB relied on advice from its 

Radiation Advisory Committee—a panel 

of non-EPA scientists, who are chosen 

for their objectivity, integrity, and 

expertise in radiation science and 

protection. 

As in BEIR VII, models in the Blue 

Book are provided which describe how 

radiogenic cancer risks depend on such 

factors as: (1) When a person is exposed, 

(2) at what age a person might get 

cancer, (3) sex, (4) and the type of 

cancer. Estimates of cancer risk are 

based on these models. However, a 

number of extensions and modifications 

to the BEIR VII models have been 

implemented. Most notably, the Blue 

Book provides: (1) Risk estimates for aparticles which were not addressed in 

BEIR VII; (2) risk estimates for some 

types of cancer that were not considered 

in BEIR VII: basal cell carcinomas, 

kidney cancer, bone sarcomas, and also 

cancers from prenatal exposures, and (3) 

a more thorough analysis of 

uncertainties associated with the 

radiogenic risk estimates. 

Underlying the risk models is a large 

body of epidemiological and 

radiobiological data. In general, results 

from both lines of research are 

consistent with a linear, no-threshold 

dose (LNT) response model in which 

the risk of inducing a cancer in an 

irradiated tissue by low doses of 

radiation is proportional to the dose to 

that tissue. The BEIR VII Committee 

unequivocally recommended continuing 

adherence to the LNT approach. EPA 

also finds strong scientific support for 

LNT, while acknowledging that new 

research might conceivably lead to 

revisions in the future. 

The most important source of data on 

radiogenic health effects is a long-term 

epidemiological study of Japanese 

atomic bomb survivors, who received an 

essentially instantaneously delivered 

dose of radiation, mostly in the form of 

g-rays. This study has important 

strengths, including: An exposure 

which can be pinpointed in time; a 

large, relatively healthy exposed 

population encompassing both genders 

and all ages; a wide range of radiation 

doses to all organs of the body, which 

can be estimated reasonably accurately; 

and detailed epidemiological follow-up 

for about 50 years. The precision of the 

derived risk estimates is higher than all 

other studies for most cancer types. 

Nevertheless uncertainties in the risk 

estimates are often quite large for 

specific cancers, and the uncertainties 

are even larger if one focuses on a 

specific gender, age at exposure, or time 

after exposure. Calculating radiogenic 

risks is further complicated because 

radiogenic risks may be different for the 

U.S. population than for the Japanese Abomb survivors. Such differences may 

be due to genetic or environmental 

factors, e.g., radiogenic lung cancer risks 

likely depend on patterns of tobacco 

use. 

In addition to the Japanese Life Span 

Study (LSS), other epidemiological 

studies provide important information 

about radiogenic cancer risks. These 

include studies of medically irradiated 

patients and groups receiving 

occupational or environmental 

exposures. For thyroid and breast 

cancers, risk estimates are based on data 

from both the A-bomb survivors and 

medically irradiated cohorts. While 

studies on populations exposed 

occupationally or environmentally have, 

so far, been of limited use in quantifying 

radiation risks, they can provide 

valuable insight into the risks from 

chronic exposures. 

Summary risk coefficients are 

provided for the U.S. population, which 

can be used to calculate average risks for 

persons exposed throughout life to a 

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31330 Federal Register / Vol. 76, No. 104 / Tuesday, May 31, 2011 / Notices 

constant dose rate. The average lifetime 

dose from natural background radiation 

(not including radon) is about 75 mGy. 

Using the summary risk coefficients in 

the Blue Book, this corresponds to about 

87 out of 10,000 people in the U.S. who 

would get cancer from natural 

background radiation, with 44 out of the 

87 resulting in death. Radiogenic risks 

(per unit dose) are substantially larger 

for childhood than adult exposures, and 

tend to be larger for females than males. 

Risks per unit dose are larger for breast, 

lung and colon cancers than for most 

other cancer sites. 

For both males and females, the 

estimated risk for cancer incidence (for 

all cancers combined) increased by 

about 35% from EPA’s previous 

estimates published in Federal 

Guidance Report 13 (FGR–13). However, 

for some individual cancer sites, relative 

changes in cancer incidence are more 

than two-fold. In general, the new EPA 

mortality estimates do not differ greatly 

from those in FGR–13; remarkably, for 

all sites combined, the estimates for 

mortality changed by less than 2% for 

both males and females. 

Aside from the case of radon (which 

is not in the scope of this report), 

human data on risks from a-particles are 

much more limited than for most other 

types of radiation. For most cancer 

types, results from laboratory 

experiments indicate that the risk per 

unit dose may be about 20 times greater 

for a-particles than for g-rays. Thus, risk 

coefficients for a-particles (for most 

cancers) are derived by multiplying the 

corresponding risk coefficients for g-rays 

by a factor of 20. 

EPA will use the scientific 

information on radiation risks provided 

in the Blue Book, together with 

information from other sources, when 

considering potential modifications and 

updates to radiation protection rules 

and guidance. The complete Blue Book, 

EPA Radiogenic Cancer Risk Models 

and Projections for the U.S. Population 

(EPA 402–R–11–001, April 2011), can 

be accessed at http://epa.gov/radiation/ 

assessment/blue-book/index.html. 

Dated: May 24, 2011. 

Michael P. Flynn, 

Director, Office of Radiation and Indoor Air. 

[FR Doc. 2011–13395 Filed 5–27–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL –9303–7] 

Notice of a Regional Project Waiver of 

Section 1605 (Buy American) of the 

American Recovery and Reinvestment 

Act of 2009 (ARRA) to the City of 

Marathon, FL 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The EPA is hereby granting a 

project waiver of the Buy American 

requirements of ARRA Section 1605 

under the authority of Section 1605(b) 

(2) [manufactured goods are not 

produced in the United States in 

sufficient and reasonably available 

quantities and of a satisfactory quality] 

to the City of Marathon, Florida for the 

purchase of nine submerged membrane 

units (SMUs), as part of an overall 

membrane bioreactor system (MBR), 

from Kubota Corporation in Japan. The 

submerged membrane unit is a specialty 

product for this project. The membrane 

bioreactor system for which this SMU 

will be used is an advanced wastewater 

treatment process, which is designed to 

meet the high quality effluent 

requirements of the waste load 

allocation, under the National Pollutant 

Discharge Elimination System (NPDES) 

permit. Additionally, the City of 

Marathon facility has specific technical 

design requirements for the installation 

of the SMUs with the membrane 

bioreactor treatment process, including 

tankage footprint, geometry, and 

configuration. Only the Kubota 

Corporation product meets all these 

requirements. The City stated that there 

are no apparent domestic manufactured 

submerged membrane units with the 

design specifications as required for this 

project. This is a project specific waiver 

and only applies to the use of the 

specified product for the ARRA project 

being approved. Waivers for these types 

of products and components have 

already been published in the Federal 

Register, however, any other ARRA 

recipient that wishes to use the same 

product must apply for a separate 

waiver based on project specific 

circumstances. Based on the review of 

the information provided, EPA has 

concluded that a waiver of the Buy 

American provisions is justified. The 

Regional Administrator is making this 

determination based on the review and 

recommendation of the EPA Region 4, 

Water Protection Division, Grants and 

Infrastructure Branch. The Assistant 

Administrator of the Office of 

Administration and Resources 

Management has concurred on this 

decision to make an exception to 

Section 1605 of ARRA. This action 

permits the City to purchase nine 

submerged membrane units 

manufactured by Kubota, for the 

proposed project being implemented by 

the City of Marathon, Florida. 

DATES: Effective Date: May 31, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Y. Edwards, Project Officer, 

Grants and SRF Section, Water 

Protection Division (WPD), (404) 562– 

9340, USEPA Region 4, 61 Forsyth St., 

SW., Atlanta, GA 30303. 

SUPPLEMENTARY INFORMATION: In 

accordance with ARRA Section 1605(c), 

the EPA hereby provides notice that it 

is granting a project waiver of the 

requirements of Sections 1605(a) of 

Public Law 111–5, Buy American 

requirements, to the City of Marathon, 

Florida, for the purchase of nine 

submerged membrane units, 

manufactured by Kubota of Japan. 

Section 1605 of the ARRA requires 

that none of the appropriated funds may 

be used for the construction, alteration, 

maintenance, or repair of a public 

building or public work unless all of the 

iron, steel, and manufactured goods 

used in the project are produced in the 

United States, or unless a waiver is 

provided to the recipient by the head of 

the appropriate agency, here the EPA. A 

waiver may be provided if EPA 

determines that (1) applying these 

requirements would be inconsistent 

with the public interest; (2) iron, steel, 

and the relevant manufactured goods 

are not produced in the United States in 

sufficient and reasonably available 

quantities and of a satisfactory quality; 

or (3) inclusion of iron, steel, and the 

relevant manufactured goods produced 

in the United States will increase the 

cost of the overall project by more than 

25 percent. 

The City has requested a waiver from 

the Buy American Provision for the 

purchase of nine submerged membrane 

units, a specialty product for this 

project. The membrane bioreactor 

system for which this SMU will be used 

is an advanced wastewater treatment 

process, which is designed to meet the 

high quality effluent requirements of the 

waste load allocation, under the NPDES 

permit. The Marathon Area 5 Waste 

Water Treatment Plant (WWTP) 

Upgrade Project is a retrofit of an 

existing WWTP that will allow it to 

meet additional flow demands 

generated by Area 5. There is no 

additional land available for the 

expansion of the WWTP. Therefore, it is 

necessary to use membrane technology 

to increase capacity without expanding 

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