Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
 
A F BPA R
S  UNDING FOR    ESEARCH 
 
, NIEHS F
INC REASED     OLLOWED 
 
I P R P
TS  EER  EVIEW  ROCESS 
 
W  A E I
HILE  LSO  XERCISING  TS 
 
D  
  ISCRETION
 
 
Daniel R. Levinson 
Inspector General 
 
August 2017 
OEI-01-15-00150   
Report i n Brief   
August 2017 
 
OEI-01-15-00150 
 
 
 
As Funding for BPA Research Increased, NIEHS 
Why OIG Did This Review  
Followed Its Peer Review Process While Also  Key Takeaway 
Bisphenol A (BPA), a chemical 
Exercising Its Discretion  
often used to produce food and  NIEHS funding for BPA research 
drink packaging, has been linked to  What OIG Found  increased significantly as it 
adverse health conditions,  Between FYs 2000 and 2015, NIEHS funding for  prioritized its research to 
including cancer.  The National  BPA research increased significantly. NIEHSs  assess BPAs link to adverse 
Institute of Environmental Health  BPA grants were concentrated among few  health conditions.  Although 
Sciences (NIEHS) funds studies that  institutions and researchers.  NIEHS used  NIEHS met the peer review 
test substances, including BPA, for  targeted announcements to fund about one- process requirements for all 
carcinogenicity and other harmful  fifth of BPA and other grants.  NIEHS met basic 
grants, it used its discretion to 
effects.  The Office of Inspector  requirements of its peer review process for all 
fund applications with less 
General (OIG) received a  grants.  NIEHS used its discretion to fund 14 
favorable scores than 
congressional request to review  percent of BPA grants out of order as compared 
competing applications for 
the extent to which NIEHS funds  to 4 percent of other grants from FYs 2010-
14 percent of BPA grants, 
research on the safety of BPA and  2015.  Finally, FDA and CDC have limited roles 
versus 4 percent of other, non-
the processes NIEHS uses in  working with NIEHS on BPA research, although 
BPA grants. 
planning and funding that  FDA contributed to the NIEHS-led Consortium 
research.  Linking Academic and Regulatory Insights on 
  BPA Toxicity. 
How OIG Did This Review  Funding for BPA Research As A Percentage of Overall NIEHS Research  
To determine whether NIEHS 
(FYs 2000-2015) 
followed its peer review process, 
12%
we analyzed and compared 
10%
101 BPA grants and 105 other, 
non-BPA grants awarded during  8%
FYs 2010-2015.  For both sets of  6%
grants, we analyzed relevant  4%
funding announcements, summary  2%
statements, funding documents, 
0%
and justifications for funding, if  0123456789012345
0000000000111111
0000000000000000
applicable.  Finally, we interviewed  2222222222222222  
staff from NIEHS, the Food and 
What OIG Concludes 
Drug Administration (FDA), and 
NIEHS may prioritize its research, as it did with BPA.  NIEHSs peer review 
the Centers for Disease Control 
process is intended to ensure that applications submitted for funding are 
and Prevention (CDC) about their 
evaluated fairly, equitably, in a timely manner, and without bias, and NIEHS 
BPA research and processes. 
followed that process.  NIEHSs procedures also give it the discretion to fund 
applications with less favorable impact scores ahead of competing 
applications by justifying them in writing.  Such discretion is allowed and 
enables NIEHS to be responsive to emerging threats to public health; 
however, applying it frequently or disproportionately in one research area 
may create an appearance of impropriety. 
Full report can be found at http://oig.hhs.gov/oei/reports/oei-01-15-00150.asp 
   
TABLE OF CONTENTS 
 
Objectives ....................................................................................................1 
Background ..................................................................................................1 
Methodology ................................................................................................7 
Findings......................................................................................................10 
Between FYs 2000 and 2015, NIEHS funding for BPA research 
increased significantly ...................................................................10 
NIEHSs BPA grants were concentrated among few institutions 
and researchers   .............................................................................13 
NIEHS used targeted announcements to fund about one-fifth of 
BPA and other grants ......................................................................15 
Although a few grant summary statements did not include all 
required information, NIEHS met basic requirements of its peer 
review process from FYs 2010-2015  ............................................15 
NIEHS used its discretion to fund 14 percent of BPA grants out of 
order as compared to 4 percent of other grants from                     
FYs 2010-2015...............................................................................17 
FDA and CDC have limited roles working with NIEHS on BPA 
research, although FDA contributed to the CLARITY research 
program ..........................................................................................18 
Conclusion .................................................................................................19 
Appendices .................................................................................................20 
A:  Point Estimates and Confidence Intervals ...............................20 
B:  Results of Independent Group T-Tests for Grant Types ...........21 
C:  NIEHS Extramural Funding and BPA Research Funding by 
Fiscal Year ......................................................................................22 
Acknowledgments......................................................................................23 
 
   
   
OBJECTIVES 
1.  To determine the extent to which the National Institute of 
Environmental Health Sciences (NIEHS) funded extramural research 
on the safety of Bisphenol A (BPA) from fiscal years (FYs) 
2000-2015. 
2.  To determine the extent to which NIEHS followed grant application 
processes related to peer review when awarding funds for BPA 
extramural research from FYs 2010-2015. 
3.  To determine the extent to which other Department of Health and 
Human Services (the Department) programs and agencies played a 
role in planning, funding, and conducting NIEHSs BPA research. 
BACKGROUND  
BPA, a chemical often used to produce food and drink packaging, has 
been linked to a variety of adverse health conditions, including cancer.1  
NIEHS funds studies that test substances, including BPA, for 
carcinogenicity and other harmful biological effects.  The Office of 
Inspector General (OIG) received a congressional request to review the 
extent to which NIEHS funds research on the safety of BPA and the 
processes NIEHS used in planning and funding that research. 
BPA 
BPA is a widely produced chemical used to make polycarbonate plastics 
and epoxy resins.  Polycarbonate plastics are found in some food and 
drink packaging, such as water and infant feeding bottles.  Epoxy resins 
are used to coat metal products such as food cans, bottle tops, and water 
supply pipes.  Other products such as cash register receipts and dental 
sealants may also include BPA.2  Because manufacturers use BPA in food 
and beverage packaging, the Food and Drug Administration (FDA) 
regulates its use.3 
                        ____________________________________________________________ 
1 Birnbaum, Linda S., et al., Consortium-Based Science:  The NIEHSs Prolonged, 
Collaborative Approach to Assessing the Health Effects of Bisphenol A, Environmental 
Health Perspectives, Volume 120, Issue 12, December 2012. 
2 National Toxicology Program, Center for the Evaluation of Risks to the Human 
Reproductive System NTP-CERHR, Monograph on the Potential Human Reproductive 
and Developmental Effects of Bisphenol A, September 2008 NIH Publication 08-5994  
pg. 1. 
3 Federal Food, Drug, and Cosmetic Act  409 (21 U.S.C.  348) and 21 CFR  174.5, 
177.1595, and 177.1555. 
 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  1 
Discretion (OEI-01-15-00150) 
   
   
BPA is found throughout the environment and in the human body.  
Humans may consume BPA that leaches from containers into food or 
drink, or absorb it through skin contact or inhalation.  A 2009 Centers for 
Disease Control and Prevention (CDC) report found that 93 percent of a 
sample of adults and children had traces of BPA in their urine.4  BPA is 
classified as an endocrine disruptor, and some research has linked it to a 
variety of adverse health conditions, including infertility, weight gain, 
early onset puberty, diabetes, and cancer.5  Research has yet to determine 
safe levels of BPA exposure or the health effects of cumulative exposure.6 
NIEHS 
The Public Health Service Act of 1944 authorizes the Secretary of the 
Department to conduct and financially support research and testing of 
substances for carcinogenicity, teratogenicity, mutagenicity, and other 
harmful biological effects.7  Within the National Institutes of Health 
(NIH), this authority is largely carried out by NIEHS.   
To fulfill its mission, NIEHS funds extramural studies through a grant-
making process.8, 9  NIEHSs grant funding strategy allows for targeted 
and nontargeted grants.  For targeted grants, NIEHS issues announcements 
seeking principal investigators (researchers) to submit applications to 
fulfill specific research objectives.10  NIEHS also accepts nontargeted 
grant applications, which may be for any research topic that falls under 
NIEHSs purview.11   
                        ____________________________________________________________ 
4 CDC, Fourth National Report on Human Exposure to Environmental Chemicals, 2009. 
5 Birnbaum, Linda S., et al. 
6 CDC Factsheet Bisphenol A (BPA), 2010.  Accessed at 
https://www.cdc.gov/biomonitoring/pdf/BisphenolA_factSheet.pdf, on July 31, 2017. 
7 Public Health Service Act  301 (42 USC  241).  
8 NIEHS also conducts intramural research.   
9 NIEHS has many different mechanisms for funding research.  For the purposes of this 
report, extramural grants applies to research and cooperative grants.     
10 NIHs policy manual refers to these announcements as requests for applications, 
requests for proposals, or program announcements.  See NIH Policy Manual, 54110 
Program Announcements and Requests for Applications, 10/1/1994, p. 5.  
11 NIEHS refers to such announcements as unsolicited. 
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Discretion (OEI-01-15-00150) 
   
   
NIEHSs Division of Extramural Research and Training (DERT) provides 
administrative guidance to NIEHS regarding extramural grants.  This 
division also acts as a liaison between NIEHS and the research community 
by guiding researchers through and overseeing the grant application 
process.12 
NIEHS generally funds research grants for more than 1 year.  After the 
first award year, NIEHS funds grants for additional years (renewals), as 
stated in the original grant applications.  In some cases, researchers incur 
additional, unexpected costs while conducting the research.  In these 
instances, NIEHS may provide supplemental funding should researchers 
apply for it. 
NIH Peer Review Process 
NIH requires all of its institutes, including NIEHS, to follow its peer 
review process.13  Research applications for grants undergo two levels of 
review:  the initial peer review and review by an advisory council.14  This 
peer review process is intended to ensure that applications for funding 
submitted to NIH are evaluated on the basis of a process that is fair, 
equitable, timely, and conducted in a manner that strives to eliminate 
bias.15 
First level of review.  A scientific review group (SRG) conducts the initial   
review.16  An SRG comprises mostly non-Federal scientists with the 
necessary expertise to evaluate the scientific merit of the grant 
applications.  To manage conflicts of interest, NIEHS has processes in 
place to ensure that individual reviewers do not review grant applications 
from the institution where they are employed.17  The SRG evaluates each 
application on the basis of the criteria included in the announcement.  
These criteria generally include scored elements, such as the significance 
                        ____________________________________________________________ 
12 NIEHS, DERT overview.  Accessed at 
https://www.niehs.nih.gov/research/supported/dert/ on August 1, 2017. 
13 Although NIH requires all of its institutes to follow its peer review process, this report 
is focused on NIEHS.  For the sake of clarity and readability, this report will refer to this 
process as a NIEHS requirement.  
14 Public Health Service Act  492 (42 USC  289a) and 42 C.F.R.  52h. 
15 NIH Grant Policy Statement (10/1/2013) Part 1, Page I-51.  Accessed at 
http://grants.nih.gov/grants/policy/nihgps_2013/ on August 1, 2017. 
16 NIHs Center for Scientific Research conducted the first level of review for 48 of 
206 grant files in our review. 
17 NIH Grant Policy Manual, 4204-204BPeer Review Process, 9/17/2013, Section 
V.C.b.6. 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  3 
Discretion (OEI-01-15-00150) 
   
   
of the research and soundness of the study design, as well as nonscored 
items, such as human subjects protections.18, 19   
DERT staff use the SRG reviews to calculate an impact score and produce 
grant summary statements for each application.  After DERT staff 
calculate the impact score, they rank the applications in slightly different 
ways depending on whether they were for a targeted or nontargeted 
funding opportunity announcement: 
  For applications to targeted funding opportunity announcements, staff 
rank the applications by the impact score assigned during the SRG. 
  For applications to nontargeted funding opportunity announcements, 
DERT staff rank the applications by percentile on the basis of their 
impact scores.20 
DERT staff package and rank both the targeted and nontargeted 
applications together for the second level of peer review and approval.  
NIEHS officials then review the ranked applications and compare them to 
NIEHSs programmatic needs.  At this point, NIEHSs peer review 
process allows for discretion.  A designated NIEHS official may choose to 
move up a less favorably ranked application for funding consideration.  
For applications to targeted funding announcements, this is called 
funding out of order.  For applications to nontargeted funding 
announcements, this is called raising to the payline.  (Hereinafter, we 
will use the term funding/funded out of order when referring to either 
instance.)   
For both targeted and nontargeted announcements, a designated NIEHS 
official must write a justification for the decision to fund out of order.  The 
applications that are approved for funding out of order then continue to the 
second level of review with the other applications (see Exhibit 1). 
   
                        ____________________________________________________________ 
18 NIH Peer Review Process.  Accessed at  
http://grants.nih.gov/grants/peer_review_process.htm, on August 1, 2017 
19 In reviewing a grant application, one or more of the SRG reviewers may find a non-
scored criterion to be unacceptable.  In these instances, the reviewers determined that the 
grant applicant may not have adequately described how the criterion will be met, or a 
description may be missing from the application.  To receive funding, the applicant must 
address concerns regarding the criterion. 
20 Starting in FY 2013, NIEHS set a payline based on these percentages.  The payline 
applies only to applications for certain nontargeted funding opportunity announcements.  
In this report, we refer to applications funded by raising to payline as funded out of 
order. 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  4 
Discretion (OEI-01-15-00150) 
   
   
Exhibit 1:  Example of a Grant With a Less Favorable Score Being 
Funded (funding out of order)  
 
Source:  OIG analysis of NIHs policies and procedures. 
Second level of review.  The National Advisory Environmental Health 
Sciences Council (the advisory council), conducts the second level of peer 
review.21   The advisory council is chaired by the NIEHS Director and 
comprises 18 non-Federal scientists and public representatives, and 
several ex officio members.22, 23 
The advisory council assesses the SRG review and provides concurrence 
that the review occurred according to NIH policy; that the roster of 
                        ____________________________________________________________ 
21 Public Health Service Act  492 (42 U.S.C.  289a) and 42 CFR  52h. 
22 Special Government Employee is defined by 18 U.S.C.  202(a). 
23 Current members of the advisory council accessed at 
http://www.niehs.nih.gov/about/boards/naehsc/roster/ on August 1, 2017. 
 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  5 
Discretion (OEI-01-15-00150) 
   
   
reviewers held the proper expertise; and that the narratives match the 
scores SRG members gave for each application.  Generally, the advisory 
council receives and approves applications en bloc, but the Director has 
the final say on which research applications receive funding and may 
choose not to fund any individual application.  The advisory councils 
deliberations over the package of grants are private.24  See Exhibit 2 for a 
summary of the peer review process.  
 
Exhibit 2:  Overview of the Peer Review Process 
 
 
 
 
 
 
 
 
 
   
 
 
 
Source:  OIG analysis of NIHs policies and procedures. 
 
National Toxicology Program 
The National Toxicology Program (NTP), led by NIEHS, is an 
interagency group that coordinates toxicity research and testing across the 
Department.  NTP works to strengthen the science base in toxicology, 
develop and validate improved testing methods, and provide information 
about potentially toxic chemicals to health regulatory and research 
agencies, scientific and medical communities, and the public.  As the lead 
agency, NIEHS is largely responsible for NTPs activities. 
                        ____________________________________________________________ 
24Government in the Sunshine Act  552b(c) (5 USC  552b(c)). 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  6 
Discretion (OEI-01-15-00150) 
   
   
NTP broadly solicits nominations of chemicals for evaluation from the 
public and private sectors.  It selected BPA for an evaluation completed in 
2007 because of the: 
  potential for human exposure from use and occurrence in the 
environment; 
  extent of public concern; 
  production volume; and  
  extensive database on animal reproductive and developmental toxicity 
studies.25  
As a result of its evaluation, NTP called for more BPA research.26  In 
2011, NIEHS and FDA jointly started the Consortium Linking Academic 
and Regulatory Insights on BPA Toxicity (CLARITY) study, which is a 
collaboration between NIEHS, FDA, and researchers to research BPA 
safety.  NIEHS provided the funding for the CLARITY study.  
FDA and CDC are also members of the NTP.  Their roles are to provide 
feedback on research proposals and to provide scientific expertise, when 
requested.  Both agencies conduct BPA research as well.  FDA conducts 
toxicological research on BPA in lab rats through an interagency 
agreement with NTP.  CDC has conducted occupational research on 
workers exposed to high levels of BPA and other chemicals.   
METHODOLOGY 
Scope 
We analyzed NIEHS grants for extramural research on BPA safety, 
including NTPs CLARITY-BPA cooperative grants, for FYs 2000-2015.  
Data Collection 
BPA Grants.  We requested from NIH a list of all NIEHS extramural 
grants related to BPA research conducted from FYs 2000-2015.  NIH 
                        ____________________________________________________________ 
25 National Toxicology Program, Center for the Evaluation of Risks to the Human 
Reproductive System NTP-CERHR, Monograph on the Potential Human Reproductive 
and Developmental Effects of Bisphenol A, September 2008 NIH Publication 08-5994  
pg. vii. 
26 Ibid., pgs. 21, 25, 31, and 38. 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  7 
Discretion (OEI-01-15-00150) 
   
   
identified these grants using its internal database.27  NIH identified 
562 BPA-related grants during this period.  For these grants, we also 
requested information about the institutions, researchers, and total funding 
amount. 
We requested additional information for a subset of these grants.  For each 
of the 101 BPA grants NIEHS funded between FYs 2010-2015, we 
requested the related funding opportunity announcements, summary 
statements, and documents related to the Advisory Council review.  For 
any grants that NIEHS funded out of order, we also requested the 
justification for doing so. 
All Other Grants.  We selected a simple random sample of 105 grants from 
the population of 1,341 grants not related to BPA research that NIEHS 
funded from FYs 2010-2015.  These grants included such topics as the 
role of pesticides in childhood cancer and the role of occupational 
exposures in cancer of the blood.  Such a sample allowed us to 
make projections to the whole population of grants and make comparisons 
between BPA and all other grants funded from FYs 2010-2015.  See 
Appendix A for point estimates, confidence intervals, and p-values. 
For each of these 105 grants, we requested the related funding opportunity 
announcements, summary statements, and documents related to the 
advisory council review.  For any grants that NIEHS awarded out of order, 
we also requested the justification for doing so. 
Structured Interviews. We conducted structured interviews with staff from 
NIEHS about NIEHS BPA research, as well as its policies and procedures 
for awarding grants.  We also conducted structured interviews with staff 
from FDA and CDC staff to determine the extent of their involvement in 
NIEHSs BPA research. 
Data Analysis 
BPA Grants.  For the 562 BPA grants funded from FYs 2000-2015, we 
analyzed the amount of funding to identify any trends, and the institutions 
and researchers to identify which were the most common. 
For the subset of 101 BPA grants funded from FYs 2010-2015, we 
analyzed the related documents to determine whether they included 
                        ____________________________________________________________ 
27 The list of BPA grants included the following types of awards: NIEHS-funded, 
competitive and noncompetitive, Superfund, and American Recovery and Reinvestment 
Act.  NIEHS awards competitive grants through the peer review process, as described.  
Noncompetitive grants are renewals after the first year of an awarded grant.  The list of 
BPA grants excluded the following types of awards: duplications, withdrawn 
applications, loan repayment applications, and applications funded by other NIH 
institutes.  
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  8 
Discretion (OEI-01-15-00150) 
   
   
records of initial and second-level peer reviews, such as complete 
summary statements and justifications for funding grants out of order.   
All Other Grants.  For the sample of 105 grants funded from FYs 
2010-2015, we analyzed the related documents to determine whether they 
included records of initial and second-level peer reviews, such as complete 
summary statements and justifications for funding grants out of order.  We 
then compared the BPA grants with the other grants to determine whether 
there is any statistical difference between the two groups with respect to 
their completeness and justifications. 
Limitations 
We did not distinguish the role that NIHs Center for Scientific Research 
played in conducting the first level of peer review for 48 of the 206 grants 
applications within our sample for analysis.  We did not independently 
confirm the reasons that NIEHS chose to award or not award any grants.  
We did not review the scientific rationales included in the justifications 
when NIEHS funded grants out of order.  Examining the factors that led to 
grant funding concentrations among institutions and researchers was also 
outside the scope of our review. 
Standards 
We conducted this study in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency. 
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  9 
Discretion (OEI-01-15-00150) 
   
   
FINDINGS 
Between FYs 2000 and 2015, NIEHS funding for BPA research 
increased significantly 
NIEHS funded $186 million in BPA research from FYs 2000-2015 (see 
Exhibit 3).  Over 80 percent ($152 million) of BPA spending during this 
period occurred since FY 2009 when BPA safety became a public concern 
and NIEHS prioritized BPA research.  
Exhibit 3:  NIEHS Funding For BPA Research, FYs 2000-2015  
 
 
Source:  OIG analysis of NIHs internal database. 
 
NIEHSs overall research budget ranged from $225 million to 
$342 million between 2000 and 2015.28  From FYs 2000-2005, NIEHS 
funding for BPA research remained steady at about $2 million per year, 
less than 1 percent of the institutes extramural research budget (see 
Exhibits 3 and 4).  By FY 2015, BPA research accounted for $30 million, 
or 9.5 percent, of NIEHSs extramural budget.29  (See Appendix C for the 
details of NIEHSs extramural budget and the percentage spent on BPA 
research by fiscal year.) 
 
  
                        ____________________________________________________________ 
28 NIEHS increased BPA funding after it received $168 million of American 
Reinvestment and Recovery Act funds and $19 million for the Superfund Research 
Program over FYs 2009 and 2010.  
29 NIEHS awarded a $9 million grant in FY 2015, skewing the data. 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  10 
Discretion (OEI-01-15-00150) 
   
   
    Exhibit 4:  Percentage of NIEHSs Extramural Research Funds  
    Awarded for BPA Research FYs 2000-2015 
   
 
 
  Source:  OIG analysis of NIHs internal database.
   
Most of NIEHSs BPA grant activity consisted of renewing and 
supplementing existing grants rather than awarding new grants.  However, 
in line with the increase in BPA funding in 2009, NIEHS funded 20 new 
grants in that year for about $12 million.  NIEHS funded the most grants 
(both new awards and renewals/supplemental) in 2010 when it issued 20 
and 58, respectively, for about $25 million (see Exhibits 5 and 6). 
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  11 
Discretion (OEI-01-15-00150) 
   
   
Exhibit 5:  Number of New and Renewal/Supplemental NIEHS BPA 
Grants From FYs 2000-2015 
 
 
 
 
 
Source:  OIG analysis of NIHs internal database. 
 
Exhibit 6:  NIEHSs Funding For New and Renewal/Supplemental 
BPA Grants From FYs 2000-2015 
 
 
Source:  OIG analysis of NIHs internal database. 
* The difference in the sum of New and Renewal/Supplemental grants funding compared to total grants funding is due to 
rounding.  
 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  12 
Discretion (OEI-01-15-00150) 
   
   
NIEHSs BPA grants were concentrated among few institutions 
and researchers   
Of the 87 institutions that received NIEHS grants for BPA research during 
FYs 2000-2015, the highest 10 percent (9 institutions) in terms of dollars 
received accounted for nearly half of the total grant dollars, with about 
$92 million.  The second-highest 10 percent of institutions received about 
one-third of that amount, with about $31 million (see Exhibit 7). 
Exhibit 7:  Concentration of NIEHS BPA Funding Among Institutions, 
FYs 2000-2015  
 
 
 
Source:  OIG analysis of NIHs internal database.
 
The mean grant value for the highest 10 percent of institutions was about 
the same as for the second-highest 10 percent, at about $380,000.  
However, the highest 10 percent received about three times as many grants 
(see Exhibit 8). 
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  13 
Discretion (OEI-01-15-00150) 
   
   
 
Exhibit 8:  Distribution of NIEHS BPA Grants Among Institutions, 
FYs 2000-2015 
 
Total  Mean  Minimum  Maximum  Median  Mean 
grant  grant  dollars  dollars  dollars  dollars 
dollars  Grant  count per  received  received  received  received 
   received   count  institution  per grant  per grant  per grant  per  grant 
Top 10 percent      
(N =9) of 
institutions by BPA 
grant dollars  $91.7 M  239  26.6  $7,878  $ 9.5 M  $324,092  $383,878 
Second 10 percent  
(N =9) of 
institutions by BPA 
grant dollars  $31.2M  82  9.1  $1,000  $ 1.2  M  $367,715  $380,839 
Remaining 80 
percent (N= 69) of 
institutions by BPA 
grant dollars  $63.0 M  241  3.5  $53,088  $1.5 M  $225,000  $261,022 
 
Source:  OIG analysis of NIHs internal database.
  
 
NIEHSs BPA research dollars are concentrated among researchers as 
well.  Of the 140 researchers that received NIEHS grants for BPA research 
during FYs 2000-2015, the top 10 percent (14 researchers) received more 
than 40 percent of the total grant dollars.  Furthermore, when combined 
with the next 10 percent (14 researchers), the top 20 percent of researchers 
received about 60 percent of the total grant dollars.     
Funding concentration among institutions and researchers may be 
explained by several factors.  For example, institutions might have 
specialized laboratories appropriate for BPA work. Similarly, researchers 
with expertise in the topic may be concentrated at certain institutions and 
skilled at BPA research and grant writing.   
 
 
 
 
 
 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  14 
Discretion (OEI-01-15-00150) 
   
   
NIEHS used targeted announcements to fund about one-fifth of 
BPA and other grants 
NIEHS used targeted funding announcements for about 22 percent of BPA 
and all other grants (see Appendix A).30  Targeted funding announcements 
specify the research topic being funded.  NIEHS ranks applications for 
targeted funding announcements against other applications with research 
proposals on the same topic.  In contrast, nontargeted announcement are 
open to applications for any research topics that fall under NIEHSs 
purview.  NIEHS ranks applications to these announcements against other 
applications that may cover a range of research topics.     
Using targeted funding announcements ensures that NIEHS has flexibility 
to choose its research priorities and to direct its research budget.  
Although a few grant summary statements did not include all 
required information, NIEHS met basic requirements of its peer 
review process from FYs 2010-2015  
One hundred percent of BPA grants and all other grants went through the 
SRG review and advisory council review processes.31  NIEHS requires all 
grant applications to go through the peer review process, which is intended 
to ensure that applications are evaluated fairly, equitably, in a timely 
manner, and without bias.   
NIEHS convened its council meetings each quarter during 
FYs 2010-2015.  The council received the packages of grants, ranked by 
DERT on the basis of SRGs first level of peer review.  During this time, 
139 SRGs reviewed the 206 grants in our review.  Ninety-eight SRGs 
reviewed only one grant application  
NIEHS prepared summary statements reflective of their SRG analyses for 
100 percent of the BPA and all other grants (see Appendix A).  These 
summary statements included impact scores and SRG rosters, and 
reflected the criteria found within the funding announcements. 
                        ____________________________________________________________ 
30 The percentage difference between BPA and other grants was not statistically 
significant at the 95 percent confidence interval.  
31 Although all 105 other grants in our sample went through SRG review and advisory 
council review, we are not certainbecause of sampling errorthat 100 percent of the 
1,341 other grants not related to BPA research that NIEHS funded from FY 20102015 
went through SRG review and advisory council review.  However, we are at least 95 
percent confident that more than 94.3 percent of that population, and possibly 100 
percent, went through SRG review and advisory council review. 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  15 
Discretion (OEI-01-15-00150) 
   
   
Summary statements for 13 percent of the grant reviews included one or 
more nonscored criteria deemed to be unacceptable by SRG reviewers.32  
Nonscored criteria include human subjects protections plans, biohazard 
plans, and vertebrate welfare.  Reviewers may consider nonscored criteria, 
such as an unacceptable human subjects protection plan, when 
determining an overall impact score.  NIEHS staff told us they have a 
process that requires grantees to address unacceptable criteria before their 
grants are funded.33 
Although the majority of summary statements for all grants met the 
relevant requirements, some did not:  6 percent of summary statements did 
not include all required information.34  One NIEHS staff member told us 
that reviewers are instructed to provide the scores and narratives in their 
reviews, but sometimes they provide less than what is requested.  
Furthermore, in two BPA grants the summary statements included only 
two reviewers, although three are required. 
   
                        ____________________________________________________________ 
32 The percentage difference between BPA and other grants was not statistically 
significant at the 95 percent confidence interval.  
33 Verifying that grant applications with unacceptable, nonscored criteria were corrected 
by the applicants was beyond the scope of our review.   
34 The percentage difference between BPA and other grants was not statistically 
significant at the 95 percent confidence interval.  
 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  16 
Discretion (OEI-01-15-00150) 
   
   
NIEHS used its discretion to fund 14 percent of BPA grants out 
of order as compared to 4 percent of other grants from 
FYs 2010 to 2015 
NIEHS was more likely to 
Excerpts From a NIEHS Officials 
award BPA grants to 
Justification For Out-of-Order 
applications with less  Funding For a BPA Grant 
favorable impact scores   
compared to their  This is [a] novel and important area 
competition than it was for  that could lead to new endpoints for 
other grant types.  NIEHS  EPI [epidemiological] studies and new 
mechanistic insights and pathways for 
awarded 14 percent of the 
the effects of BPA.  No one else is 
BPA grants, compared to 
studying these pathways and if not 
4 percent for other grants, 
funded this design and expertise will be 
with less favorable scores 
lost.  
than their competition (see 
 
Appendix A).  Such 
Reviewers noted [the] study was 
discretion is permitted if an  significantly improved[,] including 
NIEHS official justifies the  preliminary data showing BPA affects 
award by including both a  [sic] on placental function.  The central 
scientific and subjective  concern that reduced [the] score 
argument for funding despite  somewhat was that there is currently 
no data to show BPA affects [sic] on 
a less favorable SRG score. 
placental function. 
Most of the justifications we 
 
reviewed included opinions  While we have a significant portfolio 
about how valuable the  on BPA this proposal is novel and 
research was and in some  addresses an endpoint not yet 
cases specifically stated that  addressed....I would bring [this] world 
not funding the grant would  renowned placental and stem cell 
expertise into the NIEHS portfolio. 
be a missed opportunity.  See 
excerpts from one of these 
justifications in the box to the right.  In nine instances, the justifications 
disagreed with the conclusions of a specific member of the SRG or the 
SRGs review in general.   
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  17 
Discretion (OEI-01-15-00150) 
   
   
FDA and CDC have limited roles working with NIEHS on BPA 
research, although FDA contributed to the CLARITY research 
program 
FDA and CDC officials told us the two agencies have no formal role in 
NIEHSs planning and funding of BPA research.  Both agencies conduct 
their own research on BPA, as they deem appropriate.  For example, FDA 
has conducted BPA literature reviews and laboratory research that 
examined chronic exposure of BPA to a specific breed of rats.  NIEHS, in 
conjunction with FDA, required grantees to use these rats for the 
CLARITY program.  CDC conducts two studies annually on the chemical 
toxicity of BPA.   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  18 
Discretion (OEI-01-15-00150) 
   
   
CONCLUSION 
When a widely used chemical such as BPA is linked to a variety of 
adverse health effects, it is within NIEHSs mission to prioritize its 
research to determine, to the best of its ability, whether safe levels of 
exposure exist.  From 2000 to 2015, NIEHS increased its funding for BPA 
research significantly, both in total dollars and as a percentage of its 
extramural research funding.  NIEHS has significant discretion to choose 
research topics for directed funding through targeted funding 
announcements. NIEHS used targeted announcements for about one-fifth 
of BPA grants and non-BPA grants from FYs 2010-2015.    
NIEHSs peer review process is intended to ensure that applications 
submitted for funding are evaluated fairly, equitably, in a timely manner, 
and without bias.  In principle, all grant applications received for each 
announcement, whether for targeted or nontargeted funding 
announcements, are evaluated to ensure that NIEHS funds only the best 
research proposals.  We found that NIEHS followed its peer review 
process.  
    NIEHSs procedures also give it the discretion to fund applications with  
    less favorable impact scores ahead of competing applications by justifying 
    them in writing.  NIEHS used that discretion to fund 14 percent of BPA  
    grants and 4 percent of other, non-BPA grants out of order.  Such    
    discretion is allowed and enables NIEHS to be responsive to emerging  
    threats to public health; however, applying it frequently or     
    disproportionately in one research area may create an appearance of  
    impropriety.  
 
 
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  19 
Discretion (OEI-01-15-00150) 
   
   
APPENDIX A 
Point Estimates and Confidence Intervals (all estimates are for BPA 
and other grants funded FYs 2010-2015) 
 
95-percent 
 Estimate 
Sample Size  Percent  Confidence 
Description 
Interval 
Grants that used 
targeted funding 
206  21.21.21.6 %  15.4% - 29.5% 
announcements.  
 
 
BPA grants and 
all other grants 
that went through 
the SRG review  206  100%  94.3% - 100% 
and advisory 
council review 
processes. 
 
 
NIEHS prepared 
summary 
statements 
reflective of their  206  100%  94.3% - 100% 
SRG analyses for 
BPA and other 
grants. 
 
 
Grant reviews 
that included one 
of more non-
206  12.6%  7.9% - 19.5% 
scored criteria 
deemed to be 
unacceptable. 
 
 
Grant reviews 
that did not 
include all  206  5.6%  2.7% - 11.2% 
required 
information. 
 
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  20 
Discretion (OEI-01-15-00150) 
   
   
APPENDIX B 
 
Results of Independent Group T-Tests for Grant Types 
 
Grant 
Description  Estimate  p-value 
Type 
Difference 
between NIEHS- 
awarded grants 
with less  BPA  13.9% 
0.0115 
favorable scores  Other  3.8% 
than their 
competition, by 
grant type.  
 
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  21 
Discretion (OEI-01-15-00150) 
   
   
APPENDIX C 
NIEHS Extramural Funding and BPA Research Funding by 
Fiscal Year 
 
Funding 
for all 
extramural  Funding for 
research   BPA  BPA Research As a 
(in  research (in  Percentage of 
FY  millions)        millions)  Overall Research 
2000  $225.2  $1.6  0.7% 
2001  $259.8  $1.7  0.7% 
2002  $291.8  $2.2  0.8% 
2003  $306.0  $2.7  0.9% 
2004  $309.3  $2.3  0.7% 
2005  $308.6  $2.6  0.8% 
2006  $299.2  $6.3  2.1% 
2007  $312.0  $6.9  2.2% 
2008  $311.5  $8.1  2.6% 
2009  $319.7  $23.7  7.4% 
2010  $341.6  $25.5  7.5% 
2011  $327.0  $15.3  4.7% 
2012  $328.6  $17.1  5.2% 
2013  $304.7  $19.8  6.5% 
2014  $312.5  $20.1  6.4% 
2015  $311.7  $29.7  9.5% 
Total  $4,869.2  $186  3.8% 
Source:  NIEHSs internal database. 
   
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  22 
Discretion (OEI-01-15-00150) 
   
   
ACKNOWLEDGMENTS 
Chris Galvin served as team leader for this study, and Ivan Troy served as 
lead analyst.  Office of Evaluation and Inspections staff who provided 
support include Althea Hosein, Sherri Weinstein, and Christine Moritz.  
We would also like to acknowledge the contributions of other Office of 
Inspector General staff, including Jessica Swanstrom.  
We would also like to acknowledge the contributions of Russell Hereford, 
former Deputy Regional Inspector General for Evaluation and Inspections 
in the Boston regional office, who has since retired. 
This report was prepared under the direction of Joyce Greenleaf, Regional 
Inspector General for Evaluation and Inspections in the Boston regional 
office, and Kenneth Price, Deputy Regional Inspector General.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To obtain additional information concerning this report or to obtain copies, 
contact the Office of Public Affairs at Public.Affairs@oig.hhs.gov.  
As Funding for BPA Research Increased, NIEHS Followed Its Peer Review Process While Also Exercising Its  23 
Discretion (OEI-01-15-00150) 
   
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