POLICY ISSUE 

Information 

August 21, 2015 SECY-15-0104

 

FOR: The Commissioners 

FROM: Mark A. Satorius 

Executive Director for Operations 

SUBJECT: ANALYSIS OF CANCER RISKS IN POPULATIONS NEAR NUCLEAR 

FACILITIES STUDY 

PURPOSE: 

The purpose of this paper is to update the Commission on the study of cancer risks in 

populations near nuclear facilities. 

BACKGROUND: 

Each commercial nuclear power plant and fuel cycle facility that the Nuclear Regulatory 

Commission (NRC) regulates is authorized to release radioactive materials to the environment 

and expose the public and workers to radiation. These releases and exposures must comply 

with regulations and licensing documents, including dose limits for members of the public and 

concentration limits for liquid and gaseous effluent releases, as well as ensure doses are as low 

as reasonably achievable (ALARA). The staff has concluded that offsite doses to individual 

members of the public as a result of these routine releases are ALARA and a small fraction of 

the dose limits specified in Title 10 of the Code of Federal Regulations (10 CFR) Part 20, 

“Standards for Protection Against Radiation,” specifically 10 CFR 20.1301(a) and (e). The 

offsite dose to the highest exposed member of the public is also generally less than 1 percent of 

the amount of radiation the average U.S. citizen receives in a year from all background and 

medical sources. Nonetheless, some stakeholders have continued to express concerns about 

the potential effect of these releases on the health of residents living near nuclear facilities. 

CONTACT: Terry Brock, RES/DSA 

 301-415-1793 

The enclosure transmitted 

herewith contain Official Use Only 

– Sensitive Internal Information. 

When separated from the 

enclosure, this transmittal 

document is decontrolled. 

SECY NOTE: THIS SECY PAPER WITH THE 

EXCEPTION OF THE ENCLOSURE WILL BE 

RELEASED TO THE PUBLIC IN 10 WORKING 

DAYS. 
The Commissioners - 2 - 

These concerns are not new or unique to the United States. Since 2008, Canada, France, 

Germany, Great Britain, Spain, and Switzerland have all conducted epidemiological studies 

near nuclear facilities within their borders to address public health concerns. These studies 

have generally found no association between facility operations and increased cancer risks to 

the public that are attributable to the releases or radiation exposure. For example, the German 

study initially found an association of increased childhood leukemia risk within 5 kilometers of 

the facilities. However, upon examination of the offsite exposures, the authors concluded the 

increased risk could not be explained by the releases from the facilities1

. 

The NRC staff routinely interacts with stakeholders about concerns of elevated cancer risk from 

facility operations. Although the offsite releases and resultant doses to the public from routine 

facility operations are very low, communicating this very low risk can be a challenge. To help 

address these concerns, the staff has been using the 1990 National Cancer Institute (NCI) 

study, “Cancer in Populations Living near Nuclear Facilities.” NCI still supports the original 

report and has a fact sheet on the study that is publicly available on their web site at: 

http://dceg.cancer.gov/about/organization/programs-ebp/reb/fact-sheet-mortality-risk; the fact 

sheet is also in the Agencywide Documents Access and Management System (ADAMS) at 

Accession No. ML15035A630. The study was also published in the Journal of the American 

Medical Association in 19912

. In addition, other more recent epidemiological reports have been 

conducted by various State health departments. The staff relies on credible health studies to 

augment its discussions about the NRC’s regulatory programs to keep offsite doses ALARA by 

providing public health information that directly applies to the health outcomes that are often of 

concern (i.e., cancer). 

The 1990 NCI report is now more than 25 years old and focused primarily on cancer mortality, 

with limited cancer incidence (i.e., occurrence of the disease) in two states. As a result, NRC 

staff decided in 2007 to update this report, including a study of incidence if feasible, that would 

allow the staff to evaluate and communicate more contemporary cancer information for 

populations living near NRC-licensed nuclear facilities. In July 2007, the Office of Nuclear 

Regulatory Research received a formal request from the Office of Nuclear Security and Incident 

Response (NSIR), with concurrences from the Office of Nuclear Reactor Regulation (NRR), the 

Office of New Reactors (NRO), the Office of Public Affairs (OPA), and Region I requesting an 

update to the NCI study. The staff originally requested NCI to provide the update. However, 

NCI was unable to support the study and indicated these types of studies were no longer in their 

research focus. 

Therefore, the staff contracted with the National Academy of Sciences (NAS) to perform the 

update. In April 2010, the NRC requested NAS perform the update study on cancer risks in 

populations living near NRC-licensed facilities to update the 1990 NCI study. NRC and NAS 

decided to divide the study into phases. In Phase 1, NAS explored the feasibility of conducting 

an updated study by using more modern methods to perform the analysis. This was 

documented in the 2012 report, “Analysis of Cancer Risks in Populations Near Nuclear 

Facilities: Phase 1” (ADAMS Accession No. ML15035A132). The staff communicated the 

results of the Phase 1 study and the NAS recommendations for the second phase pilot studies 

 

1

 Kaatsch P, et al. “Leukaemia in Young Children Living in the Vicinity of German Nuclear Power Plants,” 

International Journal of Cancer, 2008 Feb 15; 122(4):721-6. 2

 Jablon S, Hrubec Z, and Boice JD. “Cancer in Populations Living Near Nuclear Facilities: A Survey of 

Mortality and Incidence in Two States,” The Journal of the American Medical Association, 1991 Mar 20; 

265(11):1403-1408.
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in SECY-12-0136, “Next Steps for the Analysis of Cancer Risks in Populations near Nuclear 

Facilities Study” (ADAMS Accession No. ML12249A121). In Phase 2, NAS proposed to 

conduct pilot studies to determine the ability to practically apply the Phase 1 methods at seven 

sites recommended by the NAS committee: Dresden (Illinois), Millstone (Connecticut), Oyster 

Creek (New Jersey), Haddam Neck (decommissioned; Connecticut), Big Rock Point 

(decommissioned; Michigan), San Onofre (California), and Nuclear Fuel Services (Tennessee). 

NAS selected these sites because they provide a good sampling of facilities in six States with 

different operating histories, population sizes, and levels of complexity in data retrieval from the 

State cancer registries. NAS specifically recommended the pilot study examine two study 

designs: (1) a population study of cancer diagnosis and mortality rates for multiple cancer types 

and all age groups, down to the census-tract level; and a (2) case control study of childhood 

cancers in children born within a fixed distance of a nuclear facility3

. Upon completion of the 

proposed Phase 2 pilot studies, NAS planned to determine whether further study is practical on 

a nationwide scale, and the NRC would then determine whether to perform the studies at all 

NRC-licensed facilities (i.e., balance of operating nuclear power plants and fuel-cycle facilities). 

NAS split the Phase 2 pilot study into a pilot planning project and a pilot execution project. In 

the pilot planning project NAS explored the availability of facility effluent records and access to 

the pilot study site cancer registries in the respective states. In addition, NAS solicited cost 

estimates from contractors to determine the actual costs of performing the pilot study. This is 

described in the NAS pilot planning report, “Analysis of Cancer Risks Near Nuclear Facilities: 

Phase 2 Pilot Planning” (ADAMS Accession No.: ML15035A135). 

DISCUSSION: 

NAS stated in the pilot planning report that the pilot studies are meant to determine the 

practicality of implementing the methods and study designs recommended in Phase 1. It 

emphasized that any data collected during the pilot study would have limited use for estimating 

cancer risks in populations near each of the nuclear facilities, or for the seven nuclear facilities 

combined, because of the imprecision inherent in estimates from small samples. NAS also 

cautioned that any decision to proceed with a full scope study should be based solely on 

conclusions related to practicality and not on risk estimates. 

NAS communicated to the staff that the execution phase of the pilot study would require 

significant time and resources to complete: 39 months and $8 million. The staff estimates that 

it may take NAS 8 to 10 years to complete the pilot and the subsequent nation-wide studies 

before NRC has final cancer risk results to share with NRC stakeholders—the original intent of 

the project. That would possibly prolong the study to 2025, 15 years after the start of the project 

with NAS. 

Given the NAS position regarding the limited usefulness of the pilot study results to draw 

conclusions about the risk associated with the pilot plants (or just as importantly, single 

facilities), the long duration and high cost of the pilot study, and the long duration of subsequent 

 

3

 The population-based study design uses a geographical area as the unit of observation (e.g., census tract 

as proposed by NAS, county as used in the 1990 NCI report, ZIP Code) and uses an aggregate analysis 

that looks at a study factor (exposure) and an outcome factor (disease or death) measured in the 

geographical area at the same time. This study can show possible associations between exposure and 

disease. The case-control study design compares the prevalence of risk factors or exposures in a series of 

diseased study subjects (cases) with the prevalence of risk factors or exposures in a series of disease-free 

study subjects (controls). 
The Commissioners - 4 - 

studies, the staff concluded that a more timely and less costly alternative to the NAS proposal 

should be considered. To accomplish this, the staff communicated its concerns to NAS. Staff 

requested that NAS focus on providing final results for the next phase of the study to shorten 

the study time. Specifically, staff asked NAS to focus on the Phase 1 recommended casecontrol study design and perform an analysis of a sample of facilities in the United States to 

draw statistically valid and generalizable results to the entire fleet. In response, NAS proposed 

that the pilot planning committee reconvene to examine our request for the alternate approach 

at an additional $200,000 cost for a 9-month study. After the new review, NAS estimated 

another 50 months to complete the alternate approach at an uncertain cost. 

While the staff was considering NAS’ response, the President of the U.S. National Council on 

Radiation Protection and Measurements (NCRP) approached the staff about conducting an 

update to the 1990 NCI study. NCRP is an organization chartered by the U.S. Congress in 

1964. The Charter of the Council (Public Law 88-376) states its objectives to include: collect, 

analyze, develop and disseminate in the public interest information and recommendations about 

(a) protection against radiation and (b) radiation measurements, quantities and units, particularly 

those concerned with radiation protection. The current President of NCRP was one of the 

original authors of the 1990 NCI study, and he has been following the staff activities with NAS 

with interest. NCRP indicated that it could update the 1990 NCI study report in 2 to 3 years and 

for approximately $2.5 million (staff estimate). An update to the NCI study would be a more 

modest initiative. Instead of the NAS recommended two study designs, an NCI update would 

use the same methods used in the 1990 study—a countywide population-based study design, 

no dosimetry considerations, and limited cancer incidence information. 

CONCLUSION: 

After considering the approaches described above in the context of NRC’s current and projected 

operating environment, the staff has decided to end the Cancer Study. The staff believes the 

NAS proposal is not timely and the costs are excessive. While the NCRP proposal is more 

modest in scope, and could be done faster and for significantly less cost than the NAS study, it 

continues to have the same limitations as the 1990 study (county–based and primarily 

examining only mortality rates). The staff will continue to monitor relevant health studies 

published by national and international experts and if warranted, revisit the need for an update 

to the Cancer Study. In addition, the staff will write a letter to the NAS by October 2015 

describing the basis for the staff’s conclusion to end the Cancer Study. 

RESOURCES: 

Resources are discussed in the enclosure, which is not publicly available. 

 
The Commissioners - 5 - 

COORDINATION: 

The Office of the General Counsel has reviewed this paper and has no legal objection. The 

Office of the Chief Financial Officer has reviewed this paper for resources implications and has 

no objections. 

 /RA Michael F. Weber for/ 

Mark A. Satorius 

Executive Director for Operations 

Enclosure: 

As stated
The Commissioners - 5 - 

COORDINATION: 

The Office of the General Counsel has reviewed this paper and has no legal objection. The 

Office of the Chief Financial Officer has reviewed this paper for resources implications and has 

no objections. 

 /RA Michael F. Weber for/

Mark A. Satorius 

Executive Director for Operations 

Enclosure: 

As stated 

ADAMS Accession No.: ML15141A404 (Pkg ML15141A343) 

OFFICE RES/DSA/RPB Tech Editing BC:RES/DSA/RPB D:RES/DSA R-I 

NAME T. Brock QTE R. Tadesse M. Case D. Dorman 

DATE 06/18/15 05/26/15 06/19/15 06/19/15 07/01/15 

OFFICE D:NMSS D:NRR D:NSIR D:NRO OGC 

NAME C. Haney J.Uhle for 

W. Dean 

J.Andersen for 

B. Holian 

G. Tracy B. Mizuno 

DATE 06/25/15 06/24/15 06/29/15 06/29/15 06/25/15 

OFFICE D:OPA OCFO D:RES EDO 

NAME E. Brenner T. Champion for B. Sheron M. Satorius 

(M. Weber for) 

DATE 06/23/15 06/09/15 08/12/15 08/21/15 

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