GAO 

United States Government Accountability Office

Report to Congressional Requesters

ENVIRONMENTAL 

HEALTH 

High-level Strategy 

and Leadership 

Needed to Continue 

Progress toward 

Protecting Children 

from Environmental 

Threats 

January 2010 

GAO-10-205 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

January 2010

ENVIRONMENTAL HEALTH 

High-level Strategy and Leadership Needed to 

Continue Progress toward Protecting Children from 

Highlights of GAO-10-205, a report to Environmental Threats

congressional requesters 

Exposure to toxic chemicals or 

environmental pollutants may harm 

the health of the nation’s 74 million 

children and contribute to 

increases in asthma and 

developmental impairments. In 

2007, 66 percent of children lived in 

counties exceeding allowable 

levels for at least one of the six 

principal air pollutants that cause 

or aggravate asthma, contributing 

to medical costs of $3.2 billion per 

year, according to the Centers for 

Disease Control and Prevention. 

In 1997, Executive Order 13045 

mandated that agencies place a 

high priority on children’s risks and 

required that policies, programs, 

activities, and standards address 

those risks. In response, the 

Environmental Protection Agency 

(EPA) created the Office of 

Children’s Health Protection and 

convened the Children’s Health 

Protection Advisory Committee. 

This report assesses the extent to 

which EPA has institutionalized 

consideration of children’s health 

through (1) strategies and 

priorities, (2) key offices and other 

child-focused resources, and (3) 

participation in interagency efforts. 

GAO reviewed numerous 

documents and met with EPA and 

other officials for this report. 

What GAO Recommends

GAO recommends improvements 

to help EPA protect children, and 

EPA agreed to implement them. 

GAO also suggests that Congress 

consider reinstating a governmentwide task force on children’s 

environmental health. 

EPA has developed policies and guidance to consider children, but it has not 

maintained attention to children through agency strategies and priorities. In 

1996, EPA created a national agenda on children’s health, and its 1997 and 

2000 strategic plans highlighted children’s health as a key cross-agency 

program. As a result, the agency’s research advanced the understanding of 

children’s vulnerabilities. However, EPA has not updated the agenda since 

1996, and the focus on children is absent from the 2003, 2006, and September 

2009 draft strategic plans. 

EPA has not fully used the Office of Children’s Health Protection and other 

child-focused resources. The active involvement of managers from the office 

and experts from the Children’s Health Protection Advisory Committee has 

been lacking, as has the involvement of key staff throughout EPA. Although 

EPA now has a new Director of Children’s Health, the office had not had 

consistent leadership since 2002, hampering its ability to support and facilitate 

agencywide efforts and elevate matters of importance with senior officials. 

For example, a previous director established workgroups to bring together 

officials from the program offices and the children’s health office, but a 

subsequent acting director eliminated these groups, effectively halting work 

on a key set of children’s health recommendations. In addition, the regional 

children’s health coordinators—who provide outreach and coordination for 

EPA—have no national strategy or dedicated resources. Finally, the advisory 

committee has provided hundreds of recommendations, but EPA has 

requested advice on draft regulations only three times in the last decade. 

While EPA leadership is key to national efforts to protect children from 

environmental threats, EPA’s efforts have been hampered by the expiration in 

2005 of certain provisions in the executive order. For example, the Task 

Force on Children’s Environmental Health provided EPA with a forum for 

interagency leadership on important federal efforts, such as the National 

Children’s Study. It also provided biennial reports that helped establish 

federal research priorities. 

Children Are Exposed to Many Sources of Potentially-harmful Environmental Pollutants

Air

Other

Water

Mother

Infant/

Other Diet Young Child

Air Water

Physical

factors

Inhalation, Ingestion,

Dermal

Ingestion, Inhalation, 

Dermal

Inhalation 

Ingestion,

Dermal

Breast

milk

Infant/Young Child

Exposures for the infant 

and young child can occur 

through all environmental 

media. When breastfed, 

the mother’s exposure to 

environmental media can 

be an additional source of 

exposure to the infant.

Source: EPA, A Framework For Assessing Health Risks of Envirnmental Exposure to Children (2006).

Diet

Physical

factors

View GAO-10-205 or key components.

For more information, contact John 

Stephenson at (202) 512-3841 or 

stephensonj@gao.gov. 
Page i GAO-10-205 EPA Children’s Environmental Health 

Contents 

Letter 1

Background 4 

EPA Has Not Focused Attention on Children’s Health in 

Agencywide Priorities, Strategies, and Rulemakings 15 

In Recent Years, EPA Has Not Fully Utilized Its Office of Children’s 

Health and Other Child-Focused Resources 31 

Opportunities Exist for EPA to Lead and Coordinate National 

Efforts to Protect Children from Environmental Threats 40 

Conclusions 48 

Recommendations for Executive Action 49 

Matter for Congressional Consideration 50 

Agency Comments and Our Evaluation 51 

Appendix I Scope and Methodology 52 

Appendix II EPA Policy on Evaluating Health Risks to Children 56 

Appendix III Executive Order 13045 and Amendments 59 

Appendix IV EPA Regulations Subject to Executive Order 13045 65 

Appendix V Comments from the Environmental Protection 

Agency 74 

Appendix VI GAO Contact and Staff Acknowledgments 77 

Tables 

Table 1: Provisions in Selected Environmental Statutes Expressly 

Concerning Children or Other Susceptible Subgroups 10 

Table 2: Priorities From EPA’s National Agenda and Examples of 

Related Actions 16 
Table 3: Placement of EPA’s Regional Children’s Health 

Coordinators within the Offices of the Regional 

Administrator 36 

Table 4: Key Physical Environment and Safety Indicators of 

Children’s Well-Being, 2009 44 

Table 5: Summary of Commitments and U.S. Implementation of the 

1997 Miami Declaration, as of 2002 47 

Table 6: EPA Regulations Subject to Executive Order 13045 66 

Figures 

Figure 1: Exposure Routes and Levels Change During Major 

Developmental Periods Of Childhood 5 

Figure 2: Steps Where Children Are Considered in the EPA 

Rulemaking Process 14 

Figure 3: EPA Regional Children’s Environmental Health 

Coordinator Staffing Levels by Region, in FTEs 35 

Figure 4: Number of Children’s Health Protection Advisory 

Committee Recommendations by Category 39 

Page ii GAO-10-205 EPA Children’s Environmental Health 
Abbreviations 

ACE America’s Children and the Environment

Advisory Committee Children’s Health Protection Advisory 

Committee 

CDC Centers for Disease Control and Prevention 

EPA Environmental Protection Agency 

Executive Order Executive Order 13045—Protection of 

Children from Environmental Health Risks 

and Safety Risks 

Healthy SEAT Healthy Schools Environments Assessment 

Tool 

Interagency Forum Federal Interagency Forum on Child and 

Family Statistics 

Miami Declaration Declaration of the Environmental Leaders 

of the Eight on Children’s Environmental 

Health

NAAQS National Ambient Air Quality Standards 

National Agenda National Agenda to Protect Children’s 

Health from Environmental Threats

Office of Children’s Health Office of Children’s Health Protection 

OMB Office of Management and Budget 

RAPIDS Rule and Policy Information Development 

System 

Task Force Task Force on Environmental Health Risks 

and Safety Risks to Children 

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Page iii GAO-10-205 EPA Children’s Environmental Health 
Page 1 GAO-10-205 EPA Children’s Environmental Health 

 

United States Government Accountability Office

Washington, DC 20548 

 

January 28, 2010 

The Honorable Barbara Boxer 

Chairman 

Committee on Environment and Public Works 

United States Senate 

The Honorable Amy Klobuchar 

Chairman 

Subcommittee on Children’s Health 

Committee on Environment and Public Works 

United States Senate 

Children face disproportionate health risks from environmental 

contaminants such as pollution in air, lead paint in homes, pesticide 

residues on food, and treatment-resistant microbes in drinking water. Such 

hazards contribute to asthma, cancer, neurodevelopmental disorders, and 

other diseases, and many of the nation’s 74 million children are exposed to 

them daily. In 2007, for example, 66 percent of children lived in counties 

where air exceeded one or more of the six principal pollutants.1

 Two of 

them—ozone and particulate matter—are known to cause or aggravate 

respiratory diseases such as asthma. According to the Centers for Disease 

Control and Prevention (CDC), asthma is the third most common cause of 

hospitalizations for children, resulting in $3.2 billion for treatment and 14 

million days of school lost annually. 

The environment’s effect on children’s health is complex, and scientists’ 

understanding has continued to evolve. It can be challenging to assess the 

contribution of environmental exposures to childhood illnesses, because 

factors such as family history, nutrition, and socioeconomic factors also 

contribute. Nonetheless, scientists agree that children often are more 

significantly affected by environmental risks from exposure to air 

pollution, toxic chemicals, and the disease-transmitting vectors that are 

expected to increase with global warming. Research has also shown that 

childhood exposures to environmental contaminants may affect risk of 

diseases, such as cancer, later in life. 

1

The Environmental Protection Agency sets National Ambient Air Quality Standards for 

ozone, particulate matter, sulfur dioxide, nitrogen dioxide, carbon monoxide, and lead. 
 

In the late 1990s, the federal government took several steps to make 

children’s environmental health a priority. In April 1997, the President 

signed Executive Order 13045—Protection of Children from 

Environmental Health Risks and Safety Risks (Executive Order), which 

mandated a concerted federal effort to address children’s environmental 

health and safety risks. The Executive Order established, among other 

things, an interagency Task Force on Environmental Health Risks and 

Safety Risks to Children (Task Force) and charged it with recommending 

strategies to the President for protecting children’s health and safety. Also 

in 1997, the Environmental Protection Agency (EPA) created the Office of 

Children’s Health Protection (Office of Children’s Health) to support the 

agency’s efforts and formed the Children’s Health Protection Advisory 

Committee (Advisory Committee) to provide advice, information, and 

recommendations to assist the agency in the development of regulations, 

guidance, and policies relevant to children’s health.2

EPA’s Advisory Committee and the EPA Office of Inspector General have 

raised concerns about whether the agency has continued to maintain its 

earlier focus on protecting children or capitalized on opportunities to tackle 

some significant and emerging environmental health challenges. For 

example, the Advisory Committee wrote to the EPA Administrator in April 

2007 to reflect on EPA’s achievements in the 10 years since the Executive 

Order was signed. The committee cited successes such as increased 

margins of safety for pesticides mandated under the Food Quality 

Protection Act and the creation of the National Children’s Study. However, 

the Advisory Committee also expressed serious concerns about EPA’s 

continued lack of focus on children’s environmental health issues and the 

lack of progress in addressing the committee’s many recommendations. The 

EPA Inspector General had also raised many of those concerns in 2004.3

To address concerns about EPA’s focus on children, you asked that we 

assess the agency’s consideration of children’s environmental health. In 

September 2008, we testified on our preliminary assessment of EPA’s 

efforts to address children’s environmental health, focusing on the 

 

2

In 2005, EPA expanded the office to include environmental education and aging initiatives, 

renaming it the Office of Children’s Health Protection and Environmental Education. 

3

EPA Office of Inspector General, The Effectiveness of the Office of Children’s Health 

Protection Cannot Yet Be Determined Quantitatively, Report No. 2004-P-00016 

(Washington, D.C., May 17, 2004). 

Page 2 GAO-10-205 EPA Children’s Environmental Health 
 

Advisory Committee.4 This report completes our work for you, addressing 

more broadly the extent to which EPA has institutionalized the protection 

of children’s health from environmental risks through (1) agency 

priorities, strategies, and rulemakings, including implementation of 

Executive Order 13045; (2) the use of key offices and other child-focused 

resources, such as the Office of Children’s Health and the Advisory 

Committee; and (3) involvement in federal interagency efforts to protect 

children from current and emerging environmental threats. 

To address those objectives, we interviewed officials from multiple EPA 

program offices most directly involved with children’s health issues and 

referred to long-established quality management criteria from the 

Government Performance and Results Act.5

 To assess the extent that EPA 

prioritized children’s health in its agencywide strategies and goals, we 

reviewed key EPA children’s health-related policies, strategic and 

performance plans, and guidance documents. To assess the 

implementation of the Executive Order through EPA’s rulemaking 

process, we reviewed regulations subject to the regulatory requirements of 

the order, as well as internal workgroup documents detailing EPA’s 

rulemaking—National Ambient Air Quality Standards for Particulate 

Matter—published in October 2006. To assess EPA’s use of its Advisory 

Committee, we analyzed documents—including meeting agendas, letters 

from the Advisory Committee to the EPA Administrator, and EPA’s 

response letters. To examine EPA’s involvement in national children’s 

health efforts, we identified the accomplishments of the Task Force that 

EPA co-chaired, and we reviewed reports from groups such as the Federal 

Interagency Forum on Child and Family Statistics (Interagency Forum). 

Appendix I provides a more detailed description of our scope and 

methodology. We conducted this performance audit from November 2008 

through January 2010 in accordance with generally accepted government 

auditing standards. Those standards require that we plan and perform the 

audit to obtain sufficient, appropriate evidence to provide a reasonable 

basis for our findings and conclusions based on our audit objectives. We 

believe that the evidence obtained provides a reasonable basis for our 

findings and conclusions based on our audit objectives. 

 

4

GAO, Environmental Health: EPA Efforts to Address Children’s Health Issues Need 

Greater Focus, Direction, and Top-Level Commitment, GAO-08-1155T (Washington, D.C.: 

Sept. 16, 2008). 

5

Pub. L. 103-62 (1993). 

Page 3 GAO-10-205 EPA Children’s Environmental Health 
 

Background The following section discusses issues related to children’s environmental 

health risks and key actions that EPA, the President, and Congress took in 

the early 1990s to help address those risks. 

Children’s Environmental 

Health Risks 

Children are often disproportionately affected by environmental 

contaminants, such as pesticides and lead, for many reasons, including 

greater exposure levels, unique exposure pathways, and greater 

vulnerability due to their still-developing bodies. For example, EPA noted 

that children may receive higher doses of contaminants, because they 

spend more time close to the ground; engage in more hand-to-mouth 

activities; and breathe more air, drink more water, and consume more 

food in proportion to their body weight than adults. Contaminants may 

also affect children disproportionately because of their unique exposure 

routes such as transplacental and breast milk. Figure 1 illustrates the 

relevant exposure routes during three major developmental periods of 

childhood. 

Page 4 GAO-10-205 EPA Children’s Environmental Health 
 

Figure 1: Exposure Routes and Levels Change During Major Developmental Periods Of Childhood 

Air

Other

Physical

factors

Diet

Water

Mother

Fetus

Other Diet

Air Water

Physical

factors Transplacental

Infant/

Young child

Inhalation 

Mother

Older child/

Adolescent

Inhalation, Ingestion,

Dermal

Ingestion, Inhalation, 

Dermal

Ingestion,

Dermal

Air

Other

Physical

factors

Diet

Water

Mother

Other Diet

Air Water

Physical

factors

Inhalation, Ingestion,

Dermal

Ingestion, Inhalation, 

Dermal

Ingestion,

Dermal

Breast

milk

Other

Physical

factors

Diet

Water

Other Diet

Air Water

Physical

factors

Air

Inhalation

Inhalation, Ingestion,

Dermal Ingestion

Dermal

Ingestion, Inhalation, 

Dermal

Prenatal

All exposures to the fetus occur 

transplancentally or via physical 

factors. The mother’s exposure to 

environmental media can be a

significant source of exposure for 

enviromental media for the fetus.

Infant/Young child

Exposures for the infant and

young child can occur through all 

environmental media. When breastfed, 

the mother’s exposure to environmental 

media can be an additional source of 

exposure to the infant.

Older child/Adolescent

Exposures for the child and 

adolescent can occur through all 

enviromental media. The mother’s

exposure is no longer a factor for 

the child.

Source: EPA, A Framework For Assessing Health Risks of Envirnmental Exposure to Children (2006).

Note: Arrows represent exposure routes for a given developmental period, while shaded dashed 

lines represent exposure routes that are not pertinent for the period. 

Page 5 GAO-10-205 EPA Children’s Environmental Health 
 

Children also are more vulnerable than adults because of the relative 

immaturity of their biochemical and physiological systems. For example, 

air pollutants that would produce only slight breathing difficulties in 

adults may contribute to a more serious breathing problem in young 

children because of their smaller airways. Finally, EPA has noted that 

children have limited ability to communicate and urge action about their 

environment, so others must act on their behalf. 

In 1993, the National Academy of Sciences summarized the state of the 

science concerning the effects of environmental contaminants on 

children’s health and helped institutionalize the idea that children are not 

“little adults.”6

 That groundbreaking study outlined some of the profound 

differences between children and adults and was followed, in 1996, by 

congressional enactment of the Food Quality Protection Act, which 

mandated use of a 10-fold safety factor for children in setting pesticide 

residue tolerances.7

 Since the early 1990s, scientists have expanded our 

understanding of environmental health consequences beyond childhood 

diseases and disorders and began examining how childhood exposures 

affect people throughout all lifestages. The term lifestage refers to a 

distinguishable time frame in an individual’s life characterized by unique 

and relatively stable behavioral and physiological characteristics that are 

associated with development and growth. EPA now views childhood as a 

sequence of lifestages from conception through fetal development, 

infancy, and adolescence, rather than considering children as a 

subpopulation.8

 In its 2005 Guidance on Selecting Age Groups for 

Monitoring and Assessing Childhood Exposures to Environmental 

Contaminants, EPA recommended use of the following childhood age 

groups for assessing risk from environmental exposures: 

 

6

National Research Council, National Academy of Sciences, Pesticides in the Diets of 

Infants and Children (Washington, D.C., 1993). 

7

The Food Quality Protection Act provisions allowed EPA to use a different safety factor if 

the Administrator finds that reliable data demonstrate it would be safe for infants and 

children. Pub. L. No. 104-170 § 405 (1996). 

8

The term “subpopulation” is ingrained into EPA’s past practice, as well as various laws 

that EPA administers, such as the Safe Drinking Water Act Amendments (1996). Prior to 

the publication of the 2005 Guidelines for Carcinogen Risk Assessment and the 2005 

Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to 

Environmental Contaminants, EPA described all types of groups of individuals as 

“subpopulations.” 

Page 6 GAO-10-205 EPA Children’s Environmental Health 
 

• age groups less than 12 months old include: birth to <1 month, 1 to <3 

months, 3 to <6 months, and 6 to <12 months; and 

• age groups greater than 12 months old include: 1 to <2 years, 2 to <3 years, 

3 to <6 years, 6 to <11 years, 11 to <16 years, and 16 to <21 years. 

According to EPA guidance, other lifestages, including pregnancy, nursing, 

and old age, may also be important to consider when assessing human 

exposure and health risk. 

In addition to the growing awareness about the impact that childhood 

exposures may have on health risks throughout later lifestages, awareness 

has also grown about the linkage between children’s environmental health 

and environmental justice issues such as health disparities seen in affected 

population groups. The Interagency Forum reported that the 

environmental health risks that disproportionately affect children are 

likely to disproportionately affect minority and low-income children 

because of demographic trends in the United States.9

 According to the U.S. 

Census Bureau, there were 73.9 million children ages 0 to 17 in the United 

States in 2008, 1.5 million more than in 2000. Although the number of 

children living in the United States has grown, the percentage of children 

has decreased steadily, from a peak of 36 percent at the end of the “baby 

boom” in the mid-1960s to a current 24 percent—where it is expected to 

remain through 2020. At the same time, the racial and ethnic composition 

of the country’s children is expected to diversify. 

EPA’s Early Actions to 

Institutionalize Children’s 

Environmental Health 

EPA’s mission is to protect human health and the environment and, as a 

result of mounting evidence about the special vulnerabilities of the 

developing fetus and child, the agency took actions to emphasize 

protection of children from environmental exposures. In 1995, EPA 

established an agencywide Policy on Evaluating Health Risks to 

Children, directing EPA staff to consistently and explicitly consider risks 

to infants and children as a part of risk assessments generated during its 

decision-making processes, and when setting standards to protect public 

health and the environment (see app. II). In 1996, EPA issued the National 

Agenda to Protect Children’s Health from Environmental Threats 

(National Agenda) and expanded the agency’s activities to specifically 

 

9

Interagency Forum on Child and Family Statistics, America’s Children: Key National 

Indicators of Well-Being (Washington, D.C., 2009). 

Page 7 GAO-10-205 EPA Children’s Environmental Health 
 

address risks for children, documenting EPA’s plans to achieve the 

following seven goals: 

1. Ensure that all standards set by EPA are protective of any heightened 

risks faced by children. 

2. Develop a scientific research strategy focused on the gaps in 

knowledge regarding child-specific susceptibility and exposure to 

environmental pollutants. 

3. Develop new, comprehensive policies to address cumulative and 

simultaneous exposures faced by children. 

4. Expand community right-to-know allowing families to make informed 

choices concerning environmental exposures to their children. 

5. Encourage parental responsibility for protecting their children from 

environmental health threats by providing them with basic 

information. 

6. Encourage and expand educational efforts with health care providers 

and environmental professionals so they can identify, prevent, and 

reduce environmental health threats to children. 

7. Provide the necessary funding to address children’s environmental 

health as a top priority among relative health risks. 

In 1997, EPA also established the Office of Children’s Health, within the 

Office of the Administrator, to support and facilitate the agency’s efforts to 

implement the National Agenda as well as the Executive Order. The 

office’s mission is to “make the protection of children’s health a 

fundamental goal of public health and environmental protection in the 

United States and around the world.” The office is not directly responsible 

for implementing or overseeing any EPA programs and instead carries out 

its mission by supporting and facilitating the work of other EPA offices, 

raising awareness and educating the public, participating in agency 

workgroups, and providing grant money that serves to assist communities 

in expanding awareness about children’s health issues. To inform its 

various initiatives related to children’s health, EPA also established the 

Advisory Committee in 1997. Through the Committee, leading researchers, 

academics, health care providers, nongovernmental organizations, 

industry representatives, as well as state and local government 

Page 8 GAO-10-205 EPA Children’s Environmental Health 
 

representatives advise EPA on regulations, research, and communications 

issues important to children’s health. 

Executive Order 13045—

Protection of Children 

from Environmental 

Health Risks and Safety 

Risks 

The President issued the Executive Order in April 1997, which established 

a broad policy for a concerted federal effort to address children’s 

environmental health risks and safety risks.10 The Executive Order 

required each federal agency to (1) make it a high priority to identify and 

assess environmental health risks and safety risks that may 

disproportionately affect children and (2) ensure that its policies, 

programs, activities, and standards address disproportionate risks to 

children that result from environmental health risks or safety risks (see 

app. III). The Executive Order has four other key provisions relating to 

regulatory requirements, interagency coordination and strategies, research 

coordination and integration, and tracking of children’s health indicators. 

With regard to regulations, the Executive Order requires federal agencies 

to develop two pieces of information as part of the rulemaking process: (1) 

an evaluation of the environmental health or safety effects on children of 

the planned rule; and (2) an explanation of why the planned rule is 

preferable to other potentially effective and reasonably feasible 

alternatives considered by the agency. The requirements of the Executive 

Order are among many broadly applicable regulatory requirements 

established by statutes and executive orders with which agencies must 

generally comply when issuing rulemakings. Individual rulemakings only 

trigger the specific analytical and procedural requirements of the 

Executive Order if they fall within specified conditions or impact 

thresholds. The requirements of the Executive Order are triggered if a 

rulemaking is likely to result in a rule that (1) meets the economic impact 

threshold, such as by having an annual impact of $100 million or more, and 

(2) concerns an environmental health risk or safety risk that an agency has 

reason to believe may disproportionately affect children. 

Statutory Requirements to 

Consider Children’s 

Environmental Health 

In addition to the broad mandate in the Executive Order, EPA and the 

Agency for Toxic Substances and Disease Registry are directed by 

Congress to consider children or other vulnerable populations in several 

environmental statutes. Table 1 lists those statutes and their express 

provisions related to children’s health. 

 

1062 Fed. Reg. 19,885 (Apr. 21, 1997). 

Page 9 GAO-10-205 EPA Children’s Environmental Health 
 

Table 1: Provisions in Selected Environmental Statutes Expressly Concerning Children or Other Susceptible Subgroups 

Statute Regulated activity 

Extent to which statute explicitly requires special consideration of 

children or susceptible subgroups in decision making 

Food Quality Protection 

Act

21 U.S.C. §§ 321, 331, 333, 

342, 346a

Pesticide residues on 

raw and processed 

food 

In establishing tolerances and exemptions, EPA must consider infant and 

children’s exposure, susceptibility, and cumulative effect, and apply a 10-

fold margin of safety (unless data support a different margin); ensure that 

there is a reasonable certainty that no harm will result to infants and children 

from aggregate exposure to the pesticide chemical residue; and publish a 

specific determination of safety.a

Also, factors to be considered include exposure and sensitivity of 

subgroups.b

Safe Drinking Water Act 

42 U.S.C. §§ 300f-300j-18 

Public drinking water In selecting a maximum contaminant level, EPA must analyze the effects on 

groups such as infants, children, pregnant women, the elderly, individuals 

with a history of serious illness, or other subpopulations that are identified as 

likely to be at greater risk, and subject the analysis to public notice and 

comment.c

In selecting unregulated contaminants for consideration of regulation, EPA 

must consider the effects on subgroups that comprise a meaningful portion 

of the general population (such as infants, children, pregnant women, the 

elderly, individuals with a history of serious illness, or other subpopulations) 

at higher risk than the general population.d

Federal Insecticide, 

Fungicide and Rodenticide 

Act 

7 U.S.C. §§ 136-136y 

Pesticide registrations If pesticide is for use on food, then as part of its registration and 

reregistration, a tolerance or exemption must be established or reviewed 

under FQPA; see above.e

EPA is authorized to establish packaging standards for pesticides.f

Comprehensive 

Environmental Response, 

Compensation, and 

Liability Act 

42 U.S.C. §§ 9601-9675 

Hazardous waste sites Under response authorities, health risk assessments conducted by the 

Agency for Toxic Substances and Disease Registry (ATSDR) are to 

consider susceptibility of the community.g

 ATSDR is also directed to conduct 

medical monitoring of subgroups at risk.h

Resource Conservation 

and Recovery Act 

42 U.S.C. §§ 6901-6992k 

Hazardous waste 

handling, treatment, 

storage, disposal 

In the context of hazardous waste landfill permits, where ATSDR is asked to 

do health assessments, the agency is to consider susceptibility of the 

community in conducting assessments.i

Source: GAO. 

Note: Statutes were reviewed as amended, and are cited to the codification 

a

21 U.S.C. § 346a(b)(2)(B)(vi), (C) (tolerances), (c)(2)(B) (exemptions). There are limited exceptions 

(e.g., use safer than nonuse; unavoidable residues). 

b

21 U.S.C. § 346a(b)(2)(D)(vi), (vii). 

c

42 U.S.C. § 300g-1(b)(3)(C)(i)(V). 

d

42 U.S.C. § 300g-1(b)(1)(C). 

e

7 U.S.C. §§ 136(bb), 136a(c)(5), 136a-1(g)(2)(E). 

f

7 U.S.C. § 136w(c)(3). 

g

42 U.S.C. § 9604(i)(6)(F). 

h

42 U.S.C. § 9604(i)(9)(A). 

i

42 U.S.C. § 6939a(f). 

Page 10 GAO-10-205 EPA Children’s Environmental Health 
 

In 1998, EPA helped establish eight Centers for Children’s Environmental 

Health and Disease Prevention Research, with the long-range goal of 

understanding how environmental factors affect children’s health and 

translating basic research findings into methods and interventions to 

prevent adverse health outcomes. The program is jointly funded by EPA, 

through its Science to Achieve Results grants program, and the National 

Institute of Environmental Health Sciences, with additional expertise and 

low-cost laboratory services provided by CDC.11 The program is designed 

to foster research collaboration among basic, clinical, and behavioral 

scientists with participation from local communities. 

Other Key EPA Children’s 

Environmental Health 

Protection Activities 

In 1999, EPA—and the other members of the Task Force—explored the 

feasibility of a longitudinal cohort study of environmental effects on parents 

and children, and in 2000 Congress authorized the planning and 

implementation of the National Children’s Study as part of the Children’s 

Health Act of 2000.12 The study is designed to examine the effects of 

environmental influences on the health and development of 100,000 children 

across the United States, following them from before birth until age 21, with 

the goal of improving the health and well-being of children. EPA is one of a 

consortium of federal partners currently leading the study that includes the 

U.S. Department of Health and Human Services’ National Institute of Child 

Health and Human Development, National Institute of Environmental 

Health Sciences of the National Institutes of Health, and CDC.13

In 2000, EPA published America’s Children and the Environment (ACE), 

a report that brought together quantitative information from a variety of 

sources to show trends in environmental risk factors related to the health 

and well-being of children in the United States. The ACE report provides 

trend information on levels of environmental contaminants in air, water, 

food, and soil; concentrations of contaminants measured in the bodies of 

mothers and children; and childhood diseases that may be influenced by 

environmental factors. In 2003, EPA published the second ACE report, 

adding data for additional years; new measures for important 

contaminants, exposures, and childhood illnesses; and analysis of those 

measures by children’s race, ethnicity, and family income. Since 2006, EPA 

 

11http://www.epa.gov/ncer/childrenscenters. 

12Pub. L. No. 106-310, § 1004 (2000). 

13http://nationalchildrensstudy.gov. 

Page 11 GAO-10-205 EPA Children’s Environmental Health 
 

has periodically updated the report data on its Web site.14 EPA is currently 

updating the ACE report’s measures and developing new priority topics, 

and it intends to publish a new edition by the end of 2010. 

EPA Strategic Plans—

Goals and Performance 

Measures 

EPA first recognized children’s environmental health as a cross-agency 

program in its 1997 strategic plan and related annual performance plans, 

which are required by the Government Performance and Results Act. 

EPA’s strategic plan defines its mission, goals, and means by which it will 

measure progress in addressing specific problems or challenges over the 

course of at least 5 years. It also describes specific results the agency aims 

to achieve, what actions the agency will take to realize those planned 

results, and how the agency will deal with current and foreseeable internal 

and external challenges that may hinder achieving results. An agency 

formulates its strategic plan with input from the Office of Management and 

Budget (OMB); Congress; the agency’s personnel, partners, and 

stakeholders; and the public. EPA’s strategic plan also serves a number of 

important management roles and functions related to achieving its 

mission, for example allowing agency leadership to establish and 

communicate priorities and direction through a strategic and unified 

vision. It also is the foundation of the agency’s planning system, for 

instance providing direction for programmatic functions such as human 

resources and budgeting, and serves to increase leadership accountability. 

EPA Action Development 

Process and Related 

Children’s Guidance 

EPA implements various environmental statutes in part through 

rulemakings, which are guided by its Action Development Process that 

helps the agency comply with legal requirements, executive orders, 

directives, agency guidance, and national policies. EPA finalized the 

current process in June 2004 to ensure that it uses quality information to 

support its actions and that scientific, economic, and policy issues are 

adequately addressed at the right stages in action development.15 The 

process has five major stages, each of which involves multiple steps. In the 

first stage, EPA assigns the rulemaking to one of three tiers based on the 

required level of cross-agency interactions and the nature of the 

anticipated issues, including complexity, environmental and economic 

 

14EPA, America’s Children and the Environment, http://www.epa.gov/economics/children 

(accessed Jan. 15, 2010). 

15EPA, EPA’s Action Development Process: Guidance for EPA Staff on Developing Quality 

Actions (Washington, D.C., 2004). 

Page 12 GAO-10-205 EPA Children’s Environmental Health 
 

significance, and external interest. According to agency guidance, EPA 

assigns rulemakings that are based on a human risk assessment—

including assessments of environmental health risks to children—to tier 1 

or tier 2. In the second stage, EPA uses a standard process to develop the 

proposed regulation and supporting analyses. In the third stage, EPA 

submits a regulatory package to OMB and addresses OMB comments, 

when required to do so under Executive Order 12866.16 In the fourth stage, 

EPA requests the Administrator’s signature and publishes the draft 

regulation in the Federal Register. In the fifth stage, EPA develops the 

final action and facilitates Congressional review. In developing the final 

regulation, EPA repeats many of the steps it followed to develop the draft 

regulation. The final step in the process is to submit the final regulation to 

Congress and GAO. 

In October 2006, EPA’s Office of Policy Economics and Innovation issued 

additional guidance to assist agency staff in integrating children’s health 

considerations into the process.17 The children’s guidance describes 

provisions of the Executive Order and EPA’s Policy on Evaluating Health 

Risks to Children. Figure 2 illustrates key steps in EPA’s Action 

Development Process where children are to be considered by the agency. 

 

16Executive Order 12866 directs most agencies, including EPA, to, among other things, 

assess costs and benefits of available regulatory alternatives and to submit significant rules 

to OMB’s Office of Information and Regulatory Affairs for review before they are 

published. 58 Fed. Reg. 51,735 (1993). For a summary of agencies’ responsibilities for 

rulemakings under broadly applicable requirements, see app. I of GAO, Federal 

Rulemaking: Improvements Needed to Monitoring and Evaluation of Rules Development 

as Well as to the Transparency of OMB’s Regulatory Reviews, GAO-09-205 (Washington, 

D.C.: Apr. 20, 2009). 

17EPA, EPA’s Action Development Process: Guide to Considering Children’s Health When 

Developing EPA Actions: Implementing Executive Order 13045 and EPA’s Policy on 

Evaluating Health Risks to Children (Washington, D.C., 2006).

Page 13 GAO-10-205 EPA Children’s Environmental Health 
 

Figure 2: Steps Where Children Are Considered in the EPA Rulemaking Process 

7

Workgroup 

undertakes analyses

and consultation 

required by statutes

and develops regulatory 

options

8

Options

Selection

13

Administrator signs

regulationb

Key decision point involving input from senior management

Requirement to consider children’s enviromental health

Source: GAO analysis of EPA’s Action Development Process.

14

EPA publishes

regulation in the Federal 

Register and opens

public docketc

15

Public comment 

period:

typically lasts 60 days

16

Final regulation 

developed by EPAd

9

Proposed 

regulation

and supporting 

documents prepared 

by workgroup

10

Final 

Agency 

Review

11

EPA submits

regulatory 

package to OMB 

if regulation is

significant under 

E.O. 12866

12

OMB Review:

OMB has 90 days

to review significant 

regulationsa

Some statutes

(see table 1)

and E.O. 13045 

require children’s

analyses Regulations subject to the regulatory 

requirements of E.O. 13045 

are reviewed by OMB

Workgroup plans scope and content of children’s analyses

1 

Cause for 

rulemaking: 

statute, court order, 

Presidential initiative, 

or Administrator’s

priority

2

Tiering: 

EPA assigns

rulemaking to

 tier 1 or tier 2 

3

Preliminary 

Analytic Blueprint 

prepared by 

workgroup

5

Detailed Analytic 

Blueprint (DABP)

prepared by 

workgroup

4

Early

Guidance

6

DABP 

approved by 

management

Rulemakings vary considerably in the extent to which 

children’s risks factor in key decision points

a

EPA may request a one-time 30-day extension. 

b

The Administrator may delegate signature authority to an Assistant or Associate Administrator or 

Regional Administrator. 

c

A docket can be established at any time during the rulemaking process, but should open no later 

than the date of publication in the Federal Register. A docket should contain all information relied 

upon by EPA in developing an action. 

Page 14 GAO-10-205 EPA Children’s Environmental Health 
 

d

Developing the final regulation involves reconvening the workgroup to evaluate comments received 

on the proposal and determine the appropriate next steps for preparing the final action, which could 

range from repeating all of the steps as outlined in the process for preparing the proposal to only 

doing a subset of those steps. 

EPA has not updated the National Agenda since it issued the prioritysetting document in 1996. EPA’s 1997 and 2000 strategic plans included 

children as an explicit goal or program, but the agency’s subsequent two 

plans showed a reduced emphasis on children. EPA has not systematically 

evaluated or tracked how its rulemakings addressed children’s 

environmental health risks, and regulatory requirements in the Executive 

Order have had minimal impact on EPA rulemakings. 

EPA Has Not Focused 

Attention on 

Children’s Health in 

Agencywide 

Priorities, Strategies, 

and Rulemakings 

EPA Has Not Updated the 

National Agenda in More 

than a Decade 

EPA has not updated the National Agenda to Protect Children’s Health 

from Environmental Threats in more than 10 years. Issued in 1996, the 

National Agenda established children’s environmental health as a top 

priority and a central focus of all agency efforts. In it, EPA articulated the 

agency’s commitment to children’s health by identifying an array of 

environmental threats to children and specifying a multifaceted approach 

to accomplishing its children’s health goals. The National Agenda also was 

the impetus for the creation of EPA’s Office of Children’s Health, which 

was formed to support the agency’s implementation of the National 

Agenda. These actions are consistent with our prior work on implementing 

change in the federal government, which has shown that top leadership 

must provide a clear, consistent rationale for change and develop a 

framework that helps create a new culture. Moreover, the National Agenda 

also helped to institutionalize the agency’s commitment to the issue. 

According to current and former officials from the Office of Children’s 

Health, the National Agenda and Executive Order helped legitimize the 

office’s importance across the rest of the agency. 

Several demonstrable children’s health-focused activities were initiated 

shortly after the EPA Administrator who founded the Office of Children’s 

Health issued the National Agenda (see table 2). For example, in 1999 the 

agency explored—through the Task Force—the feasibility of a 

longitudinal cohort study of environmental effects on parents and 

children, which Congress later established as the National Children’s 

Page 15 GAO-10-205 EPA Children’s Environmental Health 
 

Study.18 In 2000, EPA issued a strategy for research on environmental risks 

to children that established EPA’s long-term program goals and 

documented its rationale.19 The National Agenda also asserted EPA’s 

leadership across the federal government and called on partners in 

Congress, industry, health professions, and interest groups to adopt and 

help EPA implement these children’s health priorities. 

Table 2: Priorities From EPA’s National Agenda and Examples of Related Actions 

National Agenda priority Children’s environmental health action 

1. Ensuring that EPA standards are 

protective of potentially heightened 

risks faced by children 

• In 1997, EPA asked its Advisory Committee to recommend five existing standards 

that may merit re-evaluation. In 1999, EPA identified eight regulations and regulatory 

areas for review, including pesticide tolerances and farm worker protection standards. 

• In 1997, EPA set air standards for particulate matter and ozone to provide additional 

health protection to 35 million children and set standards for fine particulate matter for 

the first time. 

• In 1998, EPA published a final Guidance for Rule Writers to risk assessors and 

managers who are developing regulatory standards that are specifically targeted at 

pregnant women, infants, and children. 

2. Identifying and expanding scientific 

research on child-specific susceptibility 

to environmental pollutants 

• In 1998, EPA partnered with the National Institute of Environmental Health Sciences 

(NIEHS) to establish children’s health research centers to promote research and 

intervention and prevention methods in order to better understand how environmental 

factors affect children’s health. 

• In 1999, EPA helped to initiate what became the National Children’s Study (see text 

above). 

3. Developing policies addressing 

cumulative and simultaneous 

exposures 

In 1997, EPA published cumulative risk assessment guidance that recommended the 

integration of multiple sources, effects, pathways, stressors, and populations in risk 

assessments for which relevant data are available, with emphasis on sensitive subgroups 

such as infants and children. 

4. Expanding community right-to-know 

efforts 

EPA expanded public access to agency information on pollution, particularly through the 

Internet, to help people prevent pollution in their neighborhoods and protect the health of a 

community’s children. For instance, EPA developed a national listing of state fish 

consumption advisories to make the advisories more accessible. 

5. Providing information to parents on 

environmental threats in homes, 

schools, and communities 

In 1998, EPA began publication of a Children’s Environmental Health Yearbook to be a 

resource guide of EPA activities for the public. 

 

18P.L. 106-310. 

19The research strategy has not been updated since its publication. Instead, EPA integrated 

children’s environmental health into its Office of Research and Development multiyear 

human health research plans. 

Page 16 GAO-10-205 EPA Children’s Environmental Health 
 

National Agenda priority Children’s environmental health action 

6. Educating health and environmental 

professionals to prevent and reduce 

threats to children 

In 1998, EPA, in conjunction with the Agency for Toxic Substances and Disease Registry, 

established Pediatric Environmental Health Specialty Units to provide critical expertise to 

health care professionals, parents, schools, and community groups on protecting children 

from environmental hazards, as well as to work with federal, state, and local agencies to 

address children’s environmental health issues in homes, schools, and communities. 

7. Funding to address children’s 

environmental health as a top priority 

among relative health risks 

Since 1998, EPA and NIEHS share responsibility for funding the children’s health research 

centers, with EPA providing half the funding through its Science to Achieve Results 

program. 

Source: GAO analysis of EPA documents. 

EPA officials with whom we spoke recognized the importance of the 

National Agenda for helping to institutionalize children’s health as a 

priority across EPA, noting that it gave children’s health more traction and 

consideration in EPA programs and activities. In its 2004 report, EPA’s 

Inspector General stated that while EPA has taken steps toward meeting 

the goals outlined in the agenda, with programs and regional offices 

carrying out projects focused on children’s environmental health, there 

was no overall, coordinated strategy to integrate the agency’s efforts on 

behalf of children.20 Moreover, as we have previously reported and 

testified, EPA took actions that directly contradicted a National Agenda 

priority in December 2006.21 Specifically, the agency finalized a rulemaking 

that significantly reduced the amount of publicly available information 

reported to the Toxics Release Inventory about toxic chemicals released 

into air, water, and land. Ultimately, Congress acted to overturn EPA’s 

actions.22

In the first few months of 2009, EPA’s newly appointed Administrator 

recommitted the agency to helping ensure protection of children’s 

environmental health, stating in a speech that children are a driving force 

behind the agency’s priorities.23 In July 2009, she appointed a new Director 

of the Office of Children’s Health and said that the director will also serve 

as a key advisor in the Administrator’s office. In order to develop concrete 

 

20EPA Office of Inspector General, Report No. 2004-P-00016. 

21GAO, Environmental Information: EPA Actions Could Reduce the Availability of 

Environmental Information to the Public, GAO-07-464T (Washington, D.C.: Feb. 6, 2007), 

and Toxic Chemical Releases: EPA Actions Could Reduce Environmental Information 

Available to Many Communities, GAO-08-128 (Washington, D.C.: Nov. 30, 2007). 

22Omnibus Appropriations Act, 2009, Pub. L. No. 111-8, § 425 (2009). 

23Administrator Lisa P. Jackson, Remarks at the Columbia University Center for Children’s 

Environmental Health, March 30, 2009. 

Page 17 GAO-10-205 EPA Children’s Environmental Health 
 

ways to implement the new commitment, the Administrator tasked the 

new director with developing recommendations to improve regulatory and 

nonregulatory consideration of children’s environmental health across 

EPA. In September 2009, the new director outlined the following five-part 

approach to ensure protection of children’s environmental health: 

• Regulatory and policy development: EPA will work to ensure that 

regulations—for example, National Ambient Air Quality Standards 

(NAAQS)—provide for protection of children’s environmental health. It 

will also ensure that policies focus on health disparities among different 

demographic groups of children, and their causes. 

• Safe chemicals management: EPA will ensure that children, and other 

susceptible populations such as the elderly, are considered in the context 

of chemicals management programs and implementation and potential 

reform of the Toxic Substances Control Act.24

• Implementation of community-based children’s health programs: EPA 

will re-establish a pivotal and influential role in working with tribes, states, 

and local governments to design and implement policies that improve the 

environment and protect children. 

• Research and science policy: EPA will work with internal and external 

researchers to fill critical gaps in the understanding of children’s 

vulnerabilities, unique exposures, and health effects, and will apply 

science policies that appropriately reflect uncertainties in children’s 

vulnerabilities in EPA risk assessments. 

• Measuring effectiveness of EPA programs: EPA will update its report 

America’s Children and the Environment, which brings together 

quantitative information from a variety of sources to show trends in levels 

of environmental contaminants and concentrations of contaminants in the 

bodies of mothers and children, among other things. 

The director told us about some specific steps he plans to take within the 

Office of Children’s Health as part of the approach, including shifting 

resources so that the office has more public health expertise and 

realigning the office’s focus to support the development of regulations and 

child-specific programs. In addition, he said he was confident the 

Administrator would begin to make other changes related to children’s 

 

24Pub. L. 94-469 (1976); codified as amended at 15 U.S.C. §§ 2601 et seq. 

Page 18 GAO-10-205 EPA Children’s Environmental Health 
 

health strategy, although he could not provide a time frame or specific 

actions the agency had planned to implement such changes. Nonetheless, 

the EPA Administrator has yet to formalize new priorities in a visible and 

public way that contains specific actions EPA intends to take, as it did in 

the National Agenda. In contrast, EPA has publicly committed to 

improvements in other areas, such as chemicals management for which 

the agency released in September 2009 a comprehensive approach to 

enhance the agency’s chemical program.25

EPA Recent Strategic 

Plans Indicate a Reduced 

Emphasis on Children’s 

Health 

EPA identified children’s health as a cross-agency program in its 1997 and 

2000 strategic plans.26 However, EPA’s 2003 and 2006 (current) plans did 

not include children’s health as an explicit goal or program, indicating that 

the agency has placed less emphasis on protecting children’s health.27 The 

plans’ goals and measures are meant to make the key components of an 

organization’s mission explicit, thereby guiding officials in how to carry 

out the mission. In keeping with the requirements of the Government 

Performance and Results Act, EPA issued strategic plans setting forth 

goals that reflected top Administrator priorities; the plans also discuss 

cross-agency programs that cut across traditional media and 

organizational boundaries to consider, with a more comprehensive view, 

the risks posed to particular or vulnerable populations. EPA officials said 

that the agency removed this cross-agency goal when it streamlined its 

strategic plan from a 10-goal to a 5-goal structure, which was done as a 

result of EPA and OMB priorities.28 According to EPA officials, children 

are considered as part of the plans’ Goal 4, Healthy Communities and 

Ecosystems. The staff from the Office of Children’s Health told us they 

 

25In September 2009, the EPA Administrator announced a five-part comprehensive 

approach to enhance chemical management under existing laws. This approach includes 

developing chemical action plans, which should target the agency’s risk management 

efforts on chemicals of concern, and increasing public access to information about 

chemicals. 

26The Government Performance and Results Act requires that each agency prepare a 

strategic plan that defines its missions, goals, and the means by which it will measure its 

progress over a 5-year period and update them every 3 years. For example, EPA’s 1997 plan 

covered years 1997 through 2001. 

27EPA has issued four strategic plans since 1997, and is currently in the process of issuing 

its 2009-2014 plan. 

28EPA’s 2003 and 2006 strategic plans include five goals: (1) Clean Air and Global Climate 

Change, (2) Clean and Safe Water, (3) Land Preservation and Restoration, (4) Healthy 

Communities and Ecosystems, and (5) Compliance and Environmental Stewardship. 

Page 19 GAO-10-205 EPA Children’s Environmental Health 
 

were not pleased with the change to a 5-goal structure, because the 

subsequent strategic plans no longer emphasized children’s environmental 

health. In addition, the office had previously developed its own draft 

strategic plan that included a range of children’s health performance 

measures and demonstrated how such measures fit within EPA’s overall 

strategic plan. However, that work was not incorporated into, or 

referenced by, the agencywide strategic plan, in part, because the office 

had limited involvement in EPA’s strategic planning process. 

To help develop EPA’s 2009 strategic plan, the agency held meetings in 

2008 and 2009 to identify target areas for improvement. In the latest draft 

of that plan that EPA provided to us, the agency identified target areas for 

improvement—significant changes in strategy or performance 

measurement that are critical for helping the agency achieve and measure 

environmental and human health outcomes.29 We found that children’s 

health was not included as a target area in the draft strategic plan, and it is 

not yet clear to what extent children’s health will be addressed in the final 

plan, which is subject to revision before the Administrator finalizes it in 

the coming months. We also found that the Office of Children’s Health was 

not a lead office for developing the plan’s goal for Healthy Communities 

and Ecosystems. Development of this goal has been co-led by EPA’s Office 

of Prevention, Pesticides and Toxic Substances; Office of Research and 

Development; and Office of Water. EPA planning officials told us that staff 

from the Office of Children’s Health attended at least one development 

meeting for the healthy community goal. However, the office staff said 

their input was not given much weight, since three other offices were 

assigned the leadership role for coordinating the goal’s team. EPA officials 

said that a possible reason the Office of Children’s Health did not become 

central to the process was that it is not directly responsible for 

implementing or overseeing any of the programs and subobjectives under 

the Healthy Communities and Ecosystems goal. 

We recognize that EPA’s strategic plan addresses five high-level goals and 

related objectives that generally relate to major media goals such as 

improving water quality or reducing chemical risks. Therefore, the 

strategic plans contain subobjectives and strategic targets that provide a 

higher degree of specificity and allow EPA to more clearly express 

 

29The draft September 2009 strategic plan includes target areas for improvement, such as 

impacts of sustainable agriculture, global climate change, import safety, and environmental 

indicators. 

Page 20 GAO-10-205 EPA Children’s Environmental Health 
 

priorities. However, our analysis of EPA’s last two strategic plans found 

few subobjectives or strategic targets that explicitly related to children’s 

health.30 We have previously reported on the need for a strategic planning 

framework to contain critical elements such as performance goals that are 

indicative of agency priorities and also are objective, quantifiable, and 

measurable; an estimate of resources needed to meet performance goals; 

and an evaluation plan that monitors the goals.31 EPA stated in its 2006 

strategic plan that the agency directs its efforts toward the greatest threats 

in communities and the most sensitive populations, including children, 

who may be disproportionately exposed to environmental hazards. We 

found that only 2 of the 45 subobjectives relate specifically to children’s 

environmental health: (1) asthma and (2) indoor air quality at schools.32

We also found that, of the plan’s 126 strategic targets, only 3 explici

reference children or related issues: (1) reducing the percentage of women 

of childbearing age exposed to mercury, (2) eliminating lead poisoning, 

and (3) reducing blood lead levels. 

tly 

 

With regard to the draft 2009 strategic plan that EPA planning officials 

provided us, 5 subobjectives (out of a total of 62) specifically address 

children’s environmental health—reducing (1) exposure to asthma 

triggers, (2) indoor air contaminants at schools, (3) the percentage of 

women of childbearing age with mercury blood levels above safe 

thresholds, (4) blood lead levels in children, and (5) pregnant women’s 

exposure to persistent organic pollutants. 

Furthermore, regarding EPA’s draft 2009 strategic plan, we found that the 

performance measures do not clearly measure children’s health progress 

or are not explicitly linked to children’s health objectives. Performance 

measures are indicators, statistics, or metrics used to gauge program 

performance. Reliable and comprehensive performance measures allow 

the agency to judge whether its performance targets are reasonable and 

30OMB defines strategic targets as quantifiable or otherwise measurable characteristics that 

tell how well or at what level a program aspires to perform. Each subobjective typically has 

between one and four strategic targets. 

31GAO, Depot Maintenance: Improved Strategic Planning Needed to Ensure That Army 

and Marine Corps Depots Can Meet Future Maintenance Requirements, GAO-09-865

(Washington, D.C.: Sept. 17, 2009). 

32OMB defines objectives and subobjectives as statements of aim or purpose included in a 

strategic plan, required under the Government Performance and Results Act. EPA’s current 

strategic plan has 9 subobjectives under goal 1, 5 subobjectives under goals 2 and 3, 20 

subobjectives under goal 4, and 6 subobjectives under goal 5. 

Page 21 GAO-10-205 EPA Children’s Environmental Health 
 

whether it is meeting them. Moreover, as we have previously reported, 

strategic plans need to demonstrate that crosscutting programs—such as 

those for protecting children’s environmental health—use the same 

performance measures across the offices implementing the programs. Our 

analysis indicates that 4 of the 12 performance measures (associated with 

the five subobjectives EPA identified) explicitly consider children, and 

only one of them measures a health outcome—the number of children 

ages 1 to 5 with elevated blood lead levels. The other 11 measures either 

did not directly measure children’s health outcomes or were indirect 

proxy measures. We also found that for half of the 12 performance 

measures, the data or the data sources had inherent limitations. For 

example, the data source supporting the measure for “taking all essential 

actions to reduce exposure to indoor environmental asthma triggers” does 

not cover half of EPA’s target population—children from birth to 3 years 

old—the age group most susceptible to health effects from secondhand 

tobacco smoke, a key asthma trigger according to CDC. EPA officials 

acknowledged that the data gaps for some performance measures are due 

a variety of reasons, including funding limitations. They added that EPA 

cannot necessarily guarantee availability of all the data used to support its 

performance measures, some of which are provided by other agencies. 

In contrast to the EPA’s agencywide strategic plans, its Office of Research 

and Development has consistently addressed children’s environmental 

health in its research plans. For example, working with other program 

offices, the office has addressed children’s health in some of its multiyear 

research plans, which guide the direction of research over 5 or more years. 

The office develops separate multiyear plans on a variety of issues, 

including clean air, endocrine disruptors, human health risk assessments,33

and human health research. The Office of Research and Development uses 

these multiyear plans to link its Annual Performance Plan, required under 

the Government Performance and Results Act, to longer-range objectives 

contained in EPA’s strategic plan. In addition to these regular planning 

efforts, the Office of Research and Development has also developed 

strategies for addressing complex, cross-cutting programs, such as 

children’s health. For example, the office published a Human Health 

Research Strategy in September 2003. Officials from the Office of 

Research and Development told us that the office is considering updating 

its August 2000 Strategy for Research on Environmental Risks to 

 

33Risk assessment is the process EPA uses to determine the nature and magnitude of health 

risks to humans from chemical contaminants and other stressors. 

Page 22 GAO-10-205 EPA Children’s Environmental Health 
 

Children, and has held preliminary discussions with the Office of 

Children’s Health. 

The Office of Research and Development’s Human Health Research 

Program Multi-Year Plan is EPA’s primary research plan for addressing 

children’s health, according to office officials. The plan supports the 

office’s human health research program, which also provides methods to 

help reduce uncertainty in EPA’s children’s risk assessments, among other 

things. In June 2006, the office published an updated human health 

research plan for the years 2006 through 2013. The plan is organized 

according to the program’s four long-term goals and explicitly addresses 

children’s health in two of them. For example, children’s health is 

addressed in the goal to ensure that “risk assessors and risk managers use 

the office’s methods, models, and data to characterize and provide 

adequate protection for susceptible subpopulations.” The plan considers 

children’s health in all three of the research tracks supporting that goal—

lifestages, methods for longitudinal research, and research on asthma.34 In 

fact, a generally positive review of the research plan by EPA’s Board of 

Scientific Counselors—which the agency established to provide advice, 

information, and recommendations about its research program—found 

that EPA may be overemphasizing children in its research on susceptible 

subpopulations. The board recommended in its December 2009 report that 

EPA redress research program imbalances within the lifestage arm to 

match the strengths of its childhood susceptibility research thrust with an 

expanded research program addressing subgroups across the entire age 

range, including the elderly.35

EPA Has Not Evaluated or 

Consistently Documented 

How Its Rulemakings 

Address Risks to Children 

EPA’s 1995 policy directs the agency to consider the risks to infants and 

children consistently and explicitly as part of risk assessments—including 

those used to support rulemakings—or state clearly why it did not. EPA 

cannot be assured that it has thoroughly addressed risks to children, 

because it lacks a system for evaluating and documenting how the agency 

has considered them in rulemakings. We identified three examples. First, 

EPA implements the Executive Order, in part, through its efforts to 

 

34EPA’s Web site explains its lifestages research (see 

http://www.epa.gov/nerl/goals/health/lifestage.html). 

35EPA, Board of Scientific Counselors, Review of the Office of Research and Development’s 

Human Health Research Program at the U.S. Environmental Protection Agency 

(Washington, D.C., 2009). 

Page 23 GAO-10-205 EPA Children’s Environmental Health 
 

institutionalize its 1995 policy. However, EPA has not evaluated the extent 

to which its risk assessments conform to this policy.36 Officials from the 

Office of Children’s Health told us that significant information gaps remain 

concerning children’s risks. Second, EPA does not require rule writers to 

thoroughly document consideration of children in the agency’s Rule and 

Policy Information Development System (RAPIDS). EPA uses RAPIDS to 

track, approve, and report on agency actions, including rulemakings. 

RAPIDS allows EPA staff to document milestones in all phases of the 

rulemaking process and archives key information, according to EPA. 

However, RAPIDS captures limited information about human health or 

children’s environmental health considerations. It does not, for example, 

capture whether a risk assessment is conducted as part of a rulemaking. 

Furthermore, in January 2008, EPA eliminated a check-box in RAPIDS that 

indicated whether a rulemaking involved environmental health risks or 

safety risks that may pose disproportionate risks to children. EPA added 

three questions about human health impacts to RAPIDS, but those do not 

directly address disproportionate risks to children. In addition, the human 

health data maintained in RAPIDS can be inaccurate or incomplete 

because they are gathered early in the rulemaking process and are rarely 

updated later in the process, according to officials with whom we spoke. 

Finally, EPA does not require rule writers to document consideration of 

children in preambles of all published regulations, even though the Office 

of Children’s Health has urged EPA to require this. 

EPA has taken steps to comply with the Executive Order’s requirements 

by, for example, publishing updated guidance to assist rule writers in 

addressing children’s risks in October 2006.37 The guidance identifies key 

steps where rule writers should consider children in the rulemaking 

process. For example, it advises workgroups that are developing a 

regulation to describe proposed children’s analyses in their plans for data 

collection and analyses. The guidance also advises rule writers to work 

with risk assessors early in the rulemaking process to begin accumulating 

information about potential children’s risks. EPA has also developed a 

 

36EPA’s Office of Pesticide Programs noted that, as a result of the Food Quality Protection 

Act of 1996, its risk assessments routinely discuss the risks to infants and children resulting 

from use of pesticides. 

37EPA, Office of Policy, Economics, and Innovation, EPA’s Action Development Process: 

Guide to Considering Children’s Health When Developing EPA Actions: Implementing 

Executive Order 13045 and EPA’s Policy on Evaluating Health Risks to Children 

(Washington, D.C., 2006). This guide superseded EPA’s Rule Writer’s Guide to Executive 

Order 13045 (Washington, D.C., 1998). 

Page 24 GAO-10-205 EPA Children’s Environmental Health 
 

variety of guidance to assist risk assessors in addressing risks to children, 

including 2005 guidance on assessing susceptibility from early life 

exposure to carcinogens and 2008 guidance on assessing children’s 

exposures to environmental contaminants.38 EPA’s first use of the cancer 

guidance is its draft risk assessment for ethylene oxide—used to make 

antifreeze, detergents, and polyester, and as a fumigant pesticide. The 

draft assessment also includes EPA’s first use—apart from pesticide 

tolerances—of an additional safety factor for children and proposes 

reducing the agency’s 1985 standard of 3.6 parts per billion for protecting 

against cancer risks to a much stricter limit of 0.6 parts per trillion. 

According to staff from the Office of Children’s Health, some EPA staff are 

more aware than others of the need to consider children’s risks in 

rulemakings, in part because of the guidance they helped develop. 

However, officials from the office told us that EPA has not taken 

additional steps that would help institutionalize the use of the applicable 

guidance. For example, EPA does not provide rule writers with specific 

training on the guidance, according to officials. Rule writers are required 

to attend a 3-day comprehensive training course organized by EPA’s Office 

of Policy, Economics, and Innovation, but the course includes only a 

limited discussion of children’s environmental health because of 

competing demands. The Office of Children’s Health has instructed part of 

this course in the past, but has not done so since 2006, according to office 

officials. In addition, EPA has been slow to implement at least one 

guidance document aimed at improving consideration of children in risk 

assessments and economic analyses used to support rulemakings. 

Specifically, in 2005 EPA issued guidance on selecting age groups for 

monitoring and assessing childhood exposures to environmental 

contaminants, but did not use the guidance in developing a risk 

assessment until 2008.39 In another example, EPA’s Office of Policy, 

Economics, and Innovation issued guidance on assessing the economic 

value of children’s health benefits in October 2003, but the Director of the 

 

38EPA, Risk Assessment Forum, Supplemental Guidance for Assessing Susceptibility from 

Early Life Exposure to Carcinogens (Washington, D.C., 2005). EPA, Office of Research 

and Development, Child-Specific Exposure Factors Handbook (Washington, D.C., 2008). 

39EPA, Risk Assessment Forum, Guidance on Selecting Age Groups for Monitoring and 

Assessing Childhood Exposures to Environmental Contaminants (Washington, D.C., 

2005). 

Page 25 GAO-10-205 EPA Children’s Environmental Health 
 

Office of Children’s Health told us the agency could expand efforts to 

ensure that children are adequately considered in economic assessments.40

Although the Office of Children’s Health can advocate that EPA address 

disproportionate risks to children, we found that it has had a limited role 

in rulemakings for a number of reasons. Because the office is not a 

regulatory office like the Office of Air and Radiation, it does not initiate 

rulemakings. Instead, the Office of Children’s Health participates on 

regulatory workgroups as staff resources permit. Regulatory workgroups, 

which develop regulations, consist of members from EPA’s program 

offices and regional offices. EPA does not maintain reliable information on 

the number of regulatory workgroups that have included a representative 

from the Office of Children’s Health, but the office has participated on 

only a small number of regulatory workgroups because of its limited 

resources, according to office officials. They told us that from 2007 

through 2008, the office participated in final review for seven rulemakings, 

including reviews of the NAAQS for ozone and lead.41 The Office of 

Children’s Health’s limited resources may also have limited its 

participation on the regulatory workgroup responsible for EPA’s most 

recently completed review of National Ambient Air Quality Standards 

for Particulate Matter, published in October 2006. The office’s 

representative on the workgroup was not designated an official workgroup 

member who would receive all chapters of the draft regulation, according 

to internal documents that we reviewed. Furthermore, the office did not 

send a representative to two key meetings, according to the workgroup 

chairman. The office’s current director told us that he views this as a 

critical part of the office’s work, and he will increase its participation in 

EPA rulemakings. 

EPA’s rulemaking for particulate matter standards provides an illustration 

of a rulemaking in which EPA documented its efforts to comply with the 

Executive Order. For its air quality standards for particulate matter, EPA 

addressed children’s risks throughout the rulemaking process, according 

to documents and EPA officials who served on the regulatory workgroup. 

For example, it considered children in quantitative and qualitative risk 

assessments and its analysis of the scientific bases for alternative policy 

 

40EPA, Office of Children’s Health Protection and Office of Policy, Economics, and 

Innovation, Children’s Health Valuation Handbook (Washington, D.C., 2003). 

41According to the Office of Policy, Economics, and Innovation, the agency conducted final 

review for 58 tier 1 or tier 2 regulations from 2007 through 2008. 

Page 26 GAO-10-205 EPA Children’s Environmental Health 
 

options.42 In addition, EPA addressed children’s risks in internal 

documents, including briefing slides and documents for the rulemaking 

that we reviewed. The Administrator eventually selected standards that 

were less stringent than those recommended by the Office of Children’s 

Health and by EPA advisory committees. EPA documented its analyses in 

the notices of the proposed and final regulations as well as in the public 

docket, and the United States Court of Appeals for the District of 

Columbia used these analyses, in part, to support its February 2009 

decision to remand a key standard to EPA for review.43 The court stated 

that EPA had failed to explain why it believed the standard would provide 

an adequate margin of safety against illness in children and other 

vulnerable subpopulations, as required by the Clean Air Act.44 In its 

opinion, the court cited analyses by EPA staff and determined that the 

Administrator had apparently too hastily discounted studies of the effect 

of particulate matter on children. 

Regulatory Requirements 

in the Executive Order 

Have Had Minimal Impact 

on EPA Rulemakings 

The Executive Order requires EPA to evaluate the environmental health or 

safety effects on children of each of the covered regulations. However, the 

requirements had a minimal impact on rulemakings conducted between 

1998 and 200845 for three reasons: (1) the order applied to a narrow subset 

of rulemakings, (2) EPA was already considering risks to children in the 

rulemaking process when the order took effect, and (3) EPA does not 

interpret the order as requiring any particular analyses on children’s 

environmental health. Furthermore, we reviewed the preambles of all 

proposed and final regulations that EPA determined to be subject to the 

requirements, and found that EPA varied in how explicitly it addressed the 

requirements of the Executive Order therein. 

 

42EPA’s Office of Research and Development was responsible for supporting much of the 

relevant research on particulate matter. More than 40 percent of the research citations in 

the Criteria Document and the Staff Paper, key documents prepared during the action 

development process then in effect, were supported by the office, according to EPA (see 

fig. 2). 

43American Farm Bureau Federation v. EPA, 559 F. 3d 512, 519 (2009). 

44Codified as amended at 42 U.S.C. Ch. 85 (2009). 

45The Executive Order applies to rulemakings that are initiated after April 21, 1997, or for 

which a Notice of Proposed Rulemaking is published after April 21, 1998. EPA did not 

determine that any proposed or final regulations published before 1998 were subject to the 

order. 

Page 27 GAO-10-205 EPA Children’s Environmental Health 
 

First, the Executive Order only applies to a narrow subset of regulations. 

We determined that just 17 EPA rulemakings were subject to the order 

since it took effect. On average, EPA applied the order to fewer than 2 of 

the approximately 450 rulemakings it completed each year, even though 

some of those rulemakings were especially important to children’s health. 

One reason for the low number is that the order extends only to situations 

in which analysis of the regulation’s effects on children has the potential 

to influence the regulation, according to EPA’s interpretation. Thus, EPA 

does not apply the order to regulations that are based solely on technology 

performance, since health-based information cannot influence such 

regulations. EPA guidance states that the agency may be statutorily 

precluded from considering health or safety risks when setting certain 

technology-based standards. For example, under the Clean Air Act, EPA is 

required to base certain initial performance standards on emissions levels 

that are already being achieved by better-controlled and lower-emitting 

sources in an industry, and not on human health outcomes. On this basis, 

EPA determined that a proposed technology-based regulation on mercury 

emissions from cement plants, issued in May 2009, was not subject to the 

order, even though the regulation addressed an environmental health risk 

that disproportionately affects children’s health.46

Another reason the Executive Order only applies to a narrow subset of 

regulations is that it applies only to rulemakings that are considered 

economically significant under a separate executive order—Executive 

Order 12866. As a result, individual EPA rulemakings only trigger the 

Executive Order’s analytical and procedural requirements if they have an 

annual impact of $100 million or more, or will have certain material 

adverse economic effects, a criterion that excludes most of EPA’s 

regulations. This is consistent with our 2009 report that stated most major 

rulemakings triggered the analytical requirements of the Regulatory 

Flexibility Act, Executive Order 12866, and the Paperwork Reduction Act 

but few other commonly applicable rulemaking requirements such as 

Executive Order 13045.47 Between 1998 and 2008, EPA issued only 54 final 

regulations that were determined to be economically significant.48

 

46National Emission Standards for Hazardous Air Pollutants from the Portland Cement 

Manufacturing Industry Proposed Rule, 74 Fed. Reg. 21,136, 21,170 (May 6, 2009). 

47GAO-09-205. 

48Executive Order 12866 also applies to “significant” rulemakings that meet criteria other 

than economic significance; however, Executive Order 13045’s regulatory requirements are 

triggered only by economic significance. 

Page 28 GAO-10-205 EPA Children’s Environmental Health 
 

According to a 2008 study—authored by staff from the Office of Children’s 

Health—at least 65 regulations involving disproportionate risks to children 

were not subject to the Executive Order because they were not considered 

economically significant.49 Fifty of those 65 regulations concerned the 

amount of pesticides that may remain in or on food. However, for those 50 

rulemakings and the others that were not subject to the Executive Order, 

EPA must still comply with provisions in environmental statutes, such as 

the Food Quality Protection Act of 1996,50 that expressly concern children 

(see table 1). Although the scope of the Executive Order’s regulatory 

requirement is limited, EPA did apply it to some regulations that the 

agency estimated to significantly impact children’s environmental health. 

For example, it applied to three rulemakings that established the NAAQS. 

According to the Director of EPA’s Office of Children’s Health, those 

standards are among the most important decisions EPA made regarding 

children’s health. 

A second reason that the Executive Order had a minimal impact on 

rulemakings is because EPA was already considering risks to children in 

its rulemaking process when the order took effect. For example, EPA’s 

1995 Policy on Evaluating Health Risks to Children directs agency staff 

to consider the risks to infants and children consistently and explicitly in 

all risk assessments, including those that support rulemakings. Another 

reason is that federal agencies were already required to perform some of 

the analyses that the order calls for. For example, both the children’s 

executive order and Executive Order 12866, issued in 1993, require 

agencies to explain why a planned regulation is preferable to other 

“potentially effective and reasonably feasible alternatives” considered by 

the agency.51 According to EPA officials, the agency does not provide 

additional documents to the Office of Information and Regulatory Affairs if 

a proposed regulation is subject to both the children’s executive order and 

Executive Order 12866, rather than Executive Order 12866 alone. Nor has 

the Office of Information and Regulatory Affairs requested additional 

 

49D. Payne-Sturges and D. Kemp, “Ten Years of Addressing Children’s Health through 

Regulatory Policy at the U.S. Environmental Protection Agency.” Environmental Health 

Perspectives, vol. 116, no. 12 (2008). The study covered the period from April 1998 to 

December 2006. 

50Pub. L. No. 104-170, § 405 amended the standard-setting provisions of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

51Executive Order 12866 of September 30, 1993, was amended by Executive Order 13258 of 

February 26, 2002, and Executive Order 13422 of January 18, 2007, and is still in effect. 

Page 29 GAO-10-205 EPA Children’s Environmental Health 
 

information about children’s environmental health in these situations, 

according to officials from that office. 

Third, EPA does not require any particular analyses to comply with the 

Executive Order’s mandate that agencies evaluate the effects of any 

planned regulation on children. EPA has guidance to assist staff in 

complying with this requirement, but it gives staff considerable discretion. 

Furthermore, past guidance has been inconsistent. For example, the 

agency’s 2003 Children’s Health Valuation Handbook notes that one way to 

address the requirement is to analyze the costs, benefits, or other 

economic impacts of a policy on a specific subpopulation. EPA’s 2000 

Guidelines for Preparing Economic Analyses, however, states that the 

Executive Order primarily addresses risks rather than economic analyses. 

Furthermore, we found that EPA varied in how explicitly it addressed the 

requirements of the Executive Order in publication of regulations. Every 

EPA Federal Register notice of a regulation subject to the order has a 

section in the preamble specifically addressing the order. We reviewed this 

section of all relevant notices from 1998 through 2008, and EPA did not 

always provide information on how it complied with the Executive Order 

or on what it found in conducting the required analyses.52 We found that 

EPA has not consistently documented in this section how it considered 

children’s environmental health risks. Specifically, we found that EPA 

either quantified the effects on children or explained why it did not, or 

could not do so, for only 4 of the 17 of the rulemakings. We also found 

variation in the extent to which EPA provided information in the Federal 

Register notice about how the agency addressed the Executive Order’s 

requirement to evaluate the environmental health or safety effects on 

children, with some notices providing minimal information. For example, 

the notices of the final regulations establishing the NAAQS for lead, ozone, 

and particulate matter merely stated that the standards may be especially 

important for children because the contaminants in question may 

disproportionately affect children’s health. While EPA had conducted 

analyses of children’s health in developing those regulations, this section 

of the notice did not provide the public with a summary of EPA’s analyses, 

 

52Unless otherwise noted, when we refer to Federal Register notices in this section, we are 

referring to the preamble section on Executive Order 13045. The Executive Order requires 

that, for covered actions, the agency conduct and submit these analyses to OMB. The 

analyses must also be made part of the administrative record or otherwise made available 

to the public, to the extent permitted by law. The Executive Order does not require that the 

Federal Register notices for such regulations explain the agency’s analyses. 

Page 30 GAO-10-205 EPA Children’s Environmental Health 
 

making it difficult for the public to understand the basis upon which EPA 

made its decision. Finally, EPA did not include, in the section on the 

Executive Order, any explanation of why a planned regulation is 

preferable to other “potentially effective and reasonably feasible 

alternatives” in 9 of 17 rulemakings. Appendix IV provides details of our 

analysis of EPA Federal Register notices for the 17 rulemakings that we 

determined to be subject to the Executive Order’s regulatory 

requirements. 

In some cases, EPA’s preamble discussion of its compliance with the 

Executive Order went beyond identifying its requirements, while at least 

one other agency responsible for rules potentially concerning risks to 

children does not routinely address the order in its Federal Register

notices of regulations. For example, some EPA notices included 

information on data gaps that limited EPA’s ability to more fully address 

the order’s requirements. In the notice for the National Primary Drinking 

Water Regulations: Long Term 2 Enhanced Surface Water Treatment

rule, EPA stated that data were not adequate to conduct a quantitative risk 

assessment specifically for children and that EPA assumed the same risk 

for children as for the population as a whole when evaluating regulatory 

alternatives. In contrast, the Food and Drug Administration does not 

appear to have discussed the Executive Order in its notices. This includes 

its notice on the final regulation—Prevention of Salmonella Enteritidis in 

Shell Eggs During Production, Storage, and Transportation—issued in 

July 2009, even though the regulation was economically significant and 

concerned a risk that disproportionately affects children. 

EPA’s Office of Children’s Health has recently had inconsistent leadership 

and direction, and the agency has not fully utilized other child-focused 

resources, such as its regional children’s health coordinators and its 

Advisory Committee. 

In Recent Years, EPA 

Has Not Fully Utilized 

Its Office of Children’s 

Health and Other 

Child-Focused 

Resources 

Page 31 GAO-10-205 EPA Children’s Environmental Health 
 

EPA’s Office of Children’s Health experienced multiple changes in 

leadership over the last several years, impairing its ability to fulfill its 

priorities and commitments. From 2002 to 2008, the office had four acting 

directors and no permanent director.53 EPA staff told us the Office of 

Children’s Health had difficulty maintaining focus because of the varied 

priorities and initiatives of each director. For example, in 2007, the acting 

director tasked office staff to form workgroups and collaborate with 

senior program office staff across the agency in response to a set of 

recommendations from the Advisory Committee. The committee had 

recommended expanding research and committing additional EPA 

infrastructure to children’s health, among other things, and the 

Administrator and acting director had committed to addressing the 

recommendations. The office’s subsequent acting director eliminated the 

workgroups, and the office has yet to meaningfully address the Advisory 

Committee’s recommendations. The committee has previously noted 

leadership challenges in the office, writing in a December 2002 memo to 

the Administrator that the office could not continue to play a key role 

within EPA and across the nation without permanent leadership. In May 

2004, EPA’s Inspector General reported that the lack of a permanent 

director may have a negative impact on the longevity and importance of 

the children’s environmental health program within EPA.54

EPA’s Children’s Health 

Protection Office Has 

Lacked Committed and 

Consistent Leadership 

We have previously reported that career government officials in leadership 

positions can help provide the long-term focus needed to institutionalize 

reforms that political appointees’ often more limited tenure does not 

permit.55 Committed and consistent leadership is particularly important to 

the Office of Children’s Health. Its mission is broad and far reaching, 

requiring continuous integration and communication with other EPA 

offices. For example, the office participates frequently in agencywide 

workgroups such as the Science Policy Council and the Risk Assessment 

Forum. The office also contributes expertise on science issues within EPA. 

For instance, it works with agency scientists on how to consider age-

 

53The first Director of the Office of Children’s Health served almost 5 years, from 1997 

through 2002. The four subsequent acting directors, from 2002 to 2008, served an average of 

2 years. 

54EPA Office of Inspector General, The Effectiveness of the Office of Children’s Health 

Protection Cannot Yet Be Determined Quantitatively, Report No. 2004-P-00016 

(Washington, D.C.: May 17, 2004). 

55GAO, Management Reform: Elements of Successful Improvement Initiatives, 

GAO/T-GGD-00-26 (Washington, D.C.: Oct. 15, 1999). 

Page 32 GAO-10-205 EPA Children’s Environmental Health 
 

specific biological differences when conducting exposure and quantitative 

risk assessments. Leadership is also important because the office is 

supported by few resources and has a small number of staff, and because 

responsibility for implementing agencywide children’s health priorities 

ultimately resides with EPA’s program and regional offices. These 

conditions necessitate a proactive leader who can secure commitments 

from other parts of EPA to develop children-focused cross-agency 

activities. 

We also found that the effectiveness of the Office of Children’s Health has 

declined in the absence of direct and meaningful support from EPA’s 

Administrator. In our report, we wrote that sustained top leadership 

commitment is the single most important element in successfully 

implementing organizational change and that this commitment is most 

prominently shown through personal involvement of top leaders in 

developing and directing reform efforts.56 In 1997, EPA’s then-Administrator 

provided the first director of the Office of Children’s Health with the 

necessary support to pursue initiatives by, for example, endorsing the 

director’s decision to review the extent to which children’s environmental 

health was considered in EPA’s research budget and regulatory and science 

policies. EPA staff told us that the Administrator also endorsed the office’s 

work with the Office of Research and Development to incorporate children’s 

health concerns into the agency’s exposure assessment guidelines, cancer 

guidelines, and its database on chemical risks. In carrying out these 

initiatives, the former director had frequent contact with the Administrator, 

and was invited to all Administrator staff meetings, usually attending two 

each week. At these meetings, the director had the opportunity to speak 

directly with the Administrator’s chief of staff and other EPA political 

appointees on children’s health issues. Between 2001 and 2003, EPA’s 

subsequent Administrator maintained a similar level of support for the 

director of the Office of Children’s Health. For example, the Administrator 

gave the director significant responsibility for representing EPA at 

international children’s health conferences. According to three former 

directors of the office, from 2003 until the 2009 installation of the new 

permanent director of the Office of Children’s Health, the office directors 

have not been given high-profile responsibility for representing the agency. 

Furthermore, they have not had the same level of access to the Administrator, 

having no longer been invited to the Administrator’s staff meetings. The 

 

56GAO, Diversity Management: Expert-Identified Leading Practices and Agency 

Examples, GAO-05-90 (Washington, D.C.: Jan. 14, 2005). 

Page 33 GAO-10-205 EPA Children’s Environmental Health 
 

current director recently told us that, while he does not attend the 

Administrator’s regular senior-level meetings (i.e., with the assistant and 

regional administrators), he believes he has had the level of access to the 

Administrator that he needs. 

EPA’s Regions Have Widely 

Differing Staff Resources 

for Children’s Health and 

Lack Leadership from 

Headquarters 

EPA’s 10 regional offices have widely differing staff resources dedicated to 

children’s environmental health, because the regional administrators make 

that determination. As shown in figure 3, each region has a designated 

children’s environmental health coordinator, but not every region has a 

full-time coordinator. Four regions have one-fifth of a staff position or less 

dedicated to children’s health work.57 Moreover, Region 6 and Region 9—

together covering the states along the U.S. southern border—have onehundredths of a staff position for children’s environmental health. EPA’s 

regional children’s environmental health coordinators told us they believe 

they are often understaffed, and even the full-time coordinators are 

increasingly being asked to perform additional work not related 

specifically to children’s health. As a result, they are not able to fully 

dedicate themselves to children’s health. 

 

57Staff positions are measured in full-time-equivalents (FTE), which generally consists of 

one or more employed individuals who collectively complete 2,080 work hours in a given 

year. For example, one FTE can represent either one full-time employee or two half-time 

employees. 

Page 34 GAO-10-205 EPA Children’s Environmental Health 
 

Figure 3: EPA Regional Children’s Environmental Health Coordinator Staffing Levels by Region, in FTEs 

Source: EPA.

Region 8

1.0

0.5

0.01

0.0

1.0

1.0

0.1

1.0

.2

1.0

Region 10

Region 10

Region 9

Region 6

Region 7

Region 5

Region 4

Region 3

Region 2

Region 2 Region 9

Region 1

EPA Region

FTE

Note: Region 2 includes Puerto Rico and the U.S. Virgin Islands, Region 9 includes Hawaii, and 

Region 10 includes Alaska. 

In addition, EPA’s regional children’s health coordinators told us their 

roles are neither set by the Office of Children’s Health nor set to directly 

support agencywide, children-specific goals or strategies. Although the 

office facilitates information sharing among regional coordinators, 

primarily through monthly conference calls and an annual meeting, the 10 

Page 35 GAO-10-205 EPA Children’s Environmental Health 
 

regional administrators determine the responsibilities, resources, and 

organizational placement of the children’s environmental health 

coordinators within their respective region. For example, one EPA deputy 

regional administrator identified, as priority areas, three contaminants that 

pose risks to children—diesel, lead, and radon. The children’s 

environmental health coordinator in that region subsequently sought 

resources from the program office to determine how to address these 

priorities and collaborate with ongoing projects in the region. In another 

region, priority setting was done from the “bottom up,” driven largely by 

the availability of external (non-EPA) funding from sources such as 

nonprofit organizations. In addition, the Office of the Administrator has a 

lead coordinator who serves as a liaison between the regional offices and 

the eight suboffices within the Office of the Administrator (including the 

Office of Children’s Health), but the lead also has a limited role 

determining EPA’s children’s health activities, with approximately oneeighth of their time working with the Office of Children’s Health. 

According to Office of Children’s Health officials, most EPA regions do not 

have a dedicated budget to support the children’s health coordinators. 

Often, coordinators must take the initiative to obtain assistance, or get 

logistical support, from other staff from the EPA branch or division in 

which they are located. As shown in table 3, the organizational placement 

of the children’s coordinators also varies widely across the regions. That 

regional structure has led to differing priorities across regions, which may 

be appropriate in some circumstances when coordinators need to respond 

to unique regional children’s health challenges, but does not provide a 

consistent organizational mechanism that integrates the Office of 

Children’s Health or institutionalizes the Administrator’s top children’s 

health priorities across the regions. 

Table 3: Placement of EPA’s Regional Children’s Health Coordinators within the 

Offices of the Regional Administrator 

EPA region Organizational placement 

1 Office of Public Affairs 

2 Office of Strategic Programs 

3 Environmental Assessment and Innovation Division 

Office of Environmental Innovation 

4 Air, Pesticides and Toxics Management Division 

Pesticides and Toxics Substances Branch 

Children’s Health, Lead and Asbestos Section 

Page 36 GAO-10-205 EPA Children’s Environmental Health 
 

EPA region Organizational placement 

5 Land and Chemicals Division 

Chemical Management Branch 

6 Multimedia Planning and Permitting Division 

Toxics Branch 

7 Office of Public Affairs 

8 Office of Partnerships And Regulatory Assistance 

State Partnerships and Sustainable Practices Program 

9 Office of Public Affairs 

10 Office of Ecosystems, Tribal, and Public Affairs 

Ecosystems, Community Health, and Environmental Justice Branch 

Source: GAO based on EPA information. 

According to EPA officials, a key factor in ensuring effective regional 

children’s health coordinators is strong leadership and direction from the 

EPA Administrator and other top EPA officials. While regional 

administrators and other managers were involved in agencywide strategy 

and priority setting exercises related to children’s health issues starting in 

early 2001, such efforts have not taken place since 2003. At present, there 

is no formal, agencywide effort in which EPA’s regional or deputy 

administrators involve themselves in children’s health issues. Instead, EPA 

staff told us that many EPA regions react to children’s health crises, rather 

than proactively supporting programs to prevent children’s health 

problems before they arise. Furthermore, regional administrators may or 

may not take direction from the Office of Children’s Health, and several 

EPA officials stated that the office has rarely communicated its priorities 

to the EPA regional administrators or deputy regional administrators.58

The office recently told us that the new director has discussed his fivepoint approach in a call with the deputy regional administrators and 

visited four regional offices to discuss children’s health with regional staff 

and managers. 

 

58EPA’s Inspector General recommended in his 2004 report that coordination be reflected 

in EPA’s strategic plan objectives and in relevant output and outcome performance 

indicators. 

Page 37 GAO-10-205 EPA Children’s Environmental Health 
 

In September 2008, we testified that EPA had not proactively used its 

Children’s Health Protection Advisory Committee to maintain a focus on 

protecting children’s environmental health.59 As we said earlier, the 

Advisory Committee was established to provide advice, consultation, and 

recommendations to EPA in the areas of research, community outreach, 

and the development of regulations, guidance, and policies. EPA rarely 

sought out the Advisory Committee’s advice in those areas, despite 

convening the committee 33 times between 1998 and 2008 for 

presentations and discussions with EPA and non-EPA officials. We 

identified only four instances where EPA specifically asked for the 

committee’s advice on research, three instances on outreach, four 

instances on regulations, and two instances on guidance. We did not 

identify any instances where EPA sought out the committee’s advice on 

policies, including the Policy on Evaluating Health Risks to Children, 

which has not been updated since it was established in 1995. 

EPA Has Made Little Use 

of Its Children’s Health 

Protection Advisory 

Committee 

Nonetheless, the members of the Advisory Committee drafted and 

approved 74 letters to the Administrator between 1998 and 2008, to which 

EPA responded 53 times (about 73 percent). Those letters contained a 

range of information, advice, and recommendations. The Advisory 

Committee’s letters offered EPA hundreds of recommendations about a 

variety of topics related to reducing environmental health risks to 

children. We identified 607 recommendations during our review of the 

Advisory Committee’s letters. A small number of letters contained 

recommendations relating to multiple children’s environmental health 

issues, such as a May 2008 letter with recommendations about mercury 

regulation, farm worker protection standards, organophosphate 

pesticides, and air quality. However, most letters contained 

recommendations on a single issue. The number of recommendations 

varied from year to year, ranging from 120 in 2000 to 20 in 2001. We placed 

the 607 recommendations into 10 categories that demonstrate the breadth 

and depth of the Advisory Committee’s concerns. Figure 4 shows the 

number of recommendations in each category. Some recommendations 

were placed into multiple categories when, for example, a 

recommendation was related to “research” and “policy and procedures.”60

 

59GAO-08-1155T. 

60For example, we placed the following June 2008 Advisory Committee recommendation 

into both the research and the policy and procedure categories: “Additional research on 

children’s vulnerabilities to health impacts of climate change should also be a priority for 

the agency as a whole in the future.” 

Page 38 GAO-10-205 EPA Children’s Environmental Health 
 

The largest category of recommendations concerned how EPA conducts, 

prioritizes, and utilizes research on children’s environmental health. The 

next largest categories involved the agency’s policies and priorities and 

the development and use of guidance documents. 

Figure 4: Number of Children’s Health Protection Advisory Committee 

Recommendations by Category 

Number of recommendations

0

20

40

60

80

100

120

140

Source: GAO analysis of Advisory Committee letters.

Category

122 97 97 87 83 81 69 64 59 36

Tracking and indicators

Organization and

processes

awareness

Education and public

Regulations and standards

Policies and priorities

External partnership and

interagency coordination

Research

Guidance

Risk assessment

Budget and resources

Note: Because recommendations may appear in multiple categories, the number of recommendations 

shown in the figure exceeds the total number of recommendations. 

In our September 2008 testimony, we also stated that EPA had not 

substantially addressed key Advisory Committee recommendations. For 

example, EPA had not specifically acknowledged 11 of the Advisory 

Committee’s 23 recommendations concerning proposed revisions to the 

NAAQS for particulate matter, ozone, and lead. EPA did provide the 

Advisory Committee with official response letters to six of its seven 

NAAQS-related letters, but generally did not acknowledge or was 

noncommittal to the Advisory Committee’s recommendations. Instead, it 

provided a generic statement about considering the recommendations 

with all other public comments. We also testified that EPA had not fulfilled 

Page 39 GAO-10-205 EPA Children’s Environmental Health 
 

its commitment to address key recommendations submitted to EPA by the 

Advisory Committee on the 10th anniversary of the Executive Order. The 

Advisory Committee’s April 10, 2007, letter provided recommendations in 

seven areas for renewing EPA’s vision on children’s environmental health 

and its commitment to the principles outlined in the order. EPA’s June 13, 

2007, response letter directed the Office of Children’s Health to work 

collaboratively with program offices across the agency and committed the 

agency to working with the Advisory Committee to review these 

recommendations. However, while the office established workgroups 

within its Children’s Health Advisory Management Partners group to 

address each of the seven areas outlined by the Advisory Committee, a 

new acting director stopped the process in late 2007. 

In our September 2008 testimony, we recommended that the Administrator 

examine ways to more proactively use the Advisory Committee to 

reinvigorate the agency’s focus on protecting children’s health. Since that 

time, EPA’s Administrator and the Director of EPA’s Office of Children’s 

Health have met with the Advisory Committee in March and July 2009, 

respectively. In his remarks to the Advisory Committee, the Director 

expressed his commitment to more proactively use the Advisory 

Committee to support EPA’s efforts to protect children’s health. 

Specifically, he said that EPA could more effectively use the Advisory 

Committee for advice in developing regulations, and he asked for input on 

how to engage the Advisory Committee early and often in rulemakings. He 

also said that the committee could provide leadership in the area of 

science policy at EPA. He told the committee that it could advise EPA on 

developing policies for conducting research and making decisions in 

instances where EPA lacks conclusive information about children’s 

vulnerabilities. For example, the Director recently asked the committee to 

provide EPA with advice on its draft school siting guidelines. 

The Executive Order provides EPA with opportunities for leadership and 

coordination across the federal government. Key provisions of the 

Executive Order, specifically an interagency task force that reports to the 

President on federal research priorities—were allowed to lapse in 2005. 

There are other federal opportunities to set national goals and indicators 

related to children’s environmental health, such as the Interagency Forum 

on Child and Family Statistics and Healthy People 2020. 

Opportunities Exist 

for EPA to Lead and 

Coordinate National 

Efforts to Protect 

Children from 

Environmental 

Threats 

Page 40 GAO-10-205 EPA Children’s Environmental Health 
 

Task Force Provided Highlevel Opportunities for 

Strategy Development and 

Interagency Coordination 

until It Expired in 2005 

The President’s Task Force on Children’s Environmental Health Risks and 

Safety Risks was authorized by the Executive Order in April 1997 for a 

period of 4 years to provide high-level leadership and interagency 

coordination on children’s environmental health. It comprised nine cabinet 

officials and seven White House office directors and was co-chaired by the 

Administrator of EPA and the Secretary of the Department of Health and 

Human Services. The Task Force convened five times for meetings in 

October 1997, April 1998, January 1999, September 1999, and October 

2001. As part of National Children’s Health Month in October 2001, the 

President extended the Task Force for 2 years. According to EPA officials, 

the Administrator urged the President to continue the Task Force; in April 

2003, the President extended it for a final 2 years. However, the final order 

eliminated the provision for reassessing the need for continuance of the 

Task Force, which was not convened after the October 2001 meeting. 

According to EPA officials involved on the steering committee, the agency 

was not able to convene the Task Force thereafter, for reasons related to 

new priorities following the September 11, 2001, terrorist attacks. 

Nonetheless, a senior career-level staff steering committee continued to 

meet until 2005 to coordinate and implement the strategies that the Task 

Force developed to address the threats to children’s health. 

The Task Force contributed to eight areas which related to children’s 

health, including the establishment of the National Children’s Study, the 

largest long-term study of environmental influences on children’s health 

and development. The study was proposed and developed through the 

cooperation of four agencies, including EPA, to examine the effects of 

environmental influences on the health and development of more than 

100,000 children across the nation, following them from before birth until 

age 21. It was initiated as part of the Children’s Health Act of 2000. 

The Task Force also identified four major environmental and safety 

threats to children—asthma, developmental disabilities (including lead 

poisoning), cancer, and unintentional injuries—and created national 

strategies for each of them. In its strategy documents, the Task Force 

recognized that an integrated solution was needed across the federal 

government to address the complex interaction between a child’s biology, 

behavior, and the physical, chemical, biological, and social environment. 

According to the children’s health experts with whom we spoke—

including EPA’s first senior advisor for children’s health and the first 

director of the office—the Task Force provided critical leadership on 

several important initiatives such as the National Children’s Study and the 

Healthy School Environments Assessment Tool (HealthySEAT). These 

national programs focus heavily on the environmental influences on 

Page 41 GAO-10-205 EPA Children’s Environmental Health 
 

children’s health, with the National Children’s Study examining the role of 

environmental factors on health and disease and Healthy SEAT offering 

school districts a self-assessment tool for identifying and evaluating 

environmental, safety, and health hazards. 

In addition, the departments and agencies that made up the Task Force 

partnered to prepare a fiscal year 2001 interagency budget initiative to 

fund the Task Force’s initiatives in the four priority areas. The Secretary of 

Health and Human Services and the Administrator of EPA submitted the 

request to OMB with the recommendation that it be included as part of the 

President’s budget request that year. EPA officials told us that OMB’s 

involvement helped ensure that adequate funds were available to these 

agencies to address children’s health. This interagency budgeting effort 

did not continue past the last meeting of the Task Force in 2001. 

Since the Task Force’s expiration, EPA and the Department of Health and 

Human Services no longer have a high-level infrastructure or mandate to 

coordinate federal strategies for children’s environmental health and 

safety. According to the EPA staff and children’s health experts with 

whom we spoke, had the Task Force continued, it could have helped the 

federal government respond to the health and safety concerns that 

prompted the 2007 recall of 45 million toys and children’s products. 

Furthermore, since the Task Force provision of the Executive Order 

expired in 2005, the Task Force’s reports are no longer generated. Those 

reports collected and detailed the interagency research, data, and other 

information “necessary to enhance the country’s ability to understand, 

analyze, and respond to environmental health risks to children.” 

The Task Force was also charged with preparing reports on research, data, 

and other information that would enhance the federal government’s ability 

to understand, analyze, and respond to environmental health risks to 

children. In the 2003 order to extend the Task Force, the President also 

directed that each report detail the accomplishments of the Task Force 

from the date of the preceding report. Through the biennial reporting 

process, each agency on the Task Force identified and described key data 

needs related to environmental health risks to children that had arisen in 

the course of the agency’s programs and activities. The reports were made 

available to the public and intended for use by the Office of Science and 

Technology Policy and the National Science and Technology Council to 

establish national research priorities. 

Page 42 GAO-10-205 EPA Children’s Environmental Health 
 

The Executive Order also formally established the Interagency Forum on 

Child and Family Statistics, made up of representatives from federal 

statistics and research agencies and convened by the Director of OMB.61

The order required the forum to publish an annual report on the most 

important indicators of the well-being of the country’s children. As a 

result, the forum has published America’s Children: Key National 

Indicators of Well-Being each year since 1997. The 2003 amendments to 

the Executive Order required the forum to begin publishing the report 

biennially. Accordingly, the forum issued a brief report in 2004 to highlight 

selected indicators, and it publishes the full report on alternate years. The 

Interagency Forum also updates all indicators and background data each 

year on its Web site.62

EPA Has Had Varied 

Involvement in Federal 

Interagency Forum on 

Child and Family and 

Children Statistics 

According to the forum’s 2009 report: 

One important measure of children’s environmental health is the percentage of children 

living in areas in which air pollution levels are higher than the allowable levels of the 

Primary National Ambient Air Quality Standards. These standards, established by the U.S. 

Environmental Protection Agency under the Clean Air Act, are designed to protect public 

health, including the health of susceptible populations such as children and individuals 

with asthma. Ozone, particulate matter, sulfur dioxide, and nitrogen dioxide are air 

pollutants associated with increased asthma episodes and other respiratory illnesses. Lead 

can affect the development of the central nervous system in young children, and exposure 

to carbon monoxide can reduce the capacity of blood to carry oxygen. 

Table 4 shows the key national indicators for physical environment and 

safety from the 2009 report. 

 

61The forum was founded in 1994 to foster the coordination and integration of the 

collection and reporting of data on children and families. 

62http://childstats.gov. 

Page 43 GAO-10-205 EPA Children’s Environmental Health 
 

Table 4: Key Physical Environment and Safety Indicators of Children’s Well-Being, 2009 

Indicator Measure 

Previous value

(year)

Most recent value 

(year)

Change 

between years 

Outdoor and indoor air 

quality 

Children ages 0-17 living in counties in 

which levels of one or more air 

pollutants were above allowable levels 

66%

(2006)

66%

(2007)

NS 

Drinking water quality Children served by community water 

systems that did not meet all applicable 

health-based drinking water standards 

9%

(2006)

8%

(2007)

NS 

Lead in the blood of 

children 

Children ages 1-5 with blood lead level 

greater than or equal to 10 μg/dL 

2%

(1999-2002)

*

(2003-2006)

NS 

Housing problems Households with children ages 0-17 

reporting shelter cost burden, crowding, 

and/or physically inadequate housing 

40%

(2005)

43%

(2007)

NS 

Youth victims of serious 

violent crimes 

Serious violent crime victimization of 

youth ages 12-17 

14 per 1,000 (2005) 10 per 1,000 (2006) NS 

Child injury and 

mortality 

Injury deaths of children, ages 1-4 13 per 100,000 (2005) 12 per 100,000 (2006) NS 

Injury deaths of children, ages 5-14 8 per 100,000 (2005) 7 per 100,000 (2006) ↓

Injury deaths of adolescents, ages 15-

19 

50 per 100,000 (2005) 50 per 100,000 (2006) NS 

Source: Forum on Child and Family Statistics, America’s Children: Key National Indicators of Well-Being, 2009. 

Notes: 

* = Percentage is not shown because sample is too small to provide a statistically reliable estimate. 

NS = No statistically significant change. 

↑ = Statistically significant increase. 

↓ = Statistically significant decrease. 

The forum’s reports provide substantial detail about each indicator, 

including its relationship to children’s health, and identify important areas 

where indicators are needed. For example, the 2009 report identified the 

need for a broader set of indicators on (1) body burden measurements 

(i.e., levels of contaminants in blood and urine) to characterize children’s 

exposures, and (2) environmental quality to assess indoor air 

contaminants other than environmental tobacco smoke (e.g., pesticides) in 

homes, schools, and day care settings and for cumulative exposures to 

multiple environmental contaminants that children encounter daily. 

Our analysis of EPA’s involvement in the forum showed that the agency 

has not been consistently involved over the years. EPA had nearly no 

involvement in the first three reports—1997, 1998, and 1999—and, not 

surprisingly, those reports contained no indicators related to children’s 

environmental health. Beginning with the 2000 report, the Director of the 

Page 44 GAO-10-205 EPA Children’s Environmental Health 
 

Office of Children’s Health helped lead the establishment of an indicator 

on air pollution (i.e., the NAAQS). That report identified the need for 

indicators to describe children’s potential exposure to contaminants in 

drinking water and food. Subsequent reports began including an expanded 

set of indicators, including one for drinking water. Beginning in 2003, 

EPA’s newly created Office of Environmental Information led EPA’s 

involvement. In 2008, EPA’s Office of Children’s Health was again made 

the lead office for the agency. The official contact for the office is its 

Director of the Child and Aging Health Protection Division, who recently 

told us that the office again is participating and coordinating with other 

offices such as the EPA’s Office of Policy, Economics, and Innovation. 

Additional Federal Efforts 

to Address Children’s 

Environmental Health 

Risks 

In addition to the provisions of the Executive Order, there are other 

federal opportunities to address children’s environmental health, including 

Healthy People 2010 and Healthy People 2020 and the international 

commitments to environmental health through the G8 (Group of Eight) 

countries. Healthy People is led by the Department of Health and Human 

Services and is composed of 28 focus areas with a total of 467 objectives 

and targets, including 17 on environmental quality. Within each area, 

Healthy People selected a few leading indicators. The Healthy People 2010 

leading indicators for environmental quality are: 

• reduce the proportion of children, adolescents, and adults that are 

exposed to ozone above the EPA standard from 43 percent (in 1997) to 0 

percent (by the year 2010), and 

• reduce the proportion of nonsmokers exposed to environmental tobacco 

smoke (i.e., secondhand smoke) from 65 percent (in 1988-1994) to 45 

percent (in 2010). 

According to Healthy People 2010, these indicators were selected because 

poor air quality contributes to respiratory illness, cardiovascular disease, 

and cancer. For example, asthma can be triggered or worsened by 

exposure to ozone, and while the overall death rate from asthma increased 

57 percent from 1980 to 1993, for children it increased 67 percent. Healthy 

People 2010 is national in scope and includes identifying health indicators, 

collecting data, and reporting on progress toward meeting a range of 

health goals. In fact, the data sources for tracking most environmental 

indicators come from EPA. 

EPA’s environmental regulations and standards are key to achieving 

national environmental health objectives. EPA was not a lead federal 

Page 45 GAO-10-205 EPA Children’s Environmental Health 
 

agency in efforts to develop the Healthy People 2010 goals and indicators 

for environmental quality or the Federal Interagency Workgroup for 

Healthy People 2020. The agencies involved in Healthy People 2010 and 

2020 are the Agency for Toxic Substances and Disease Registry, CDC, and 

the National Institutes of Health—each within the Department of Health 

and Human Services, the department that formerly co-chaired the Task 

Force with EPA. 

With regard to international agreements, while the United States reiterated 

its commitment to protect children from environmental threats at the most 

recent meeting of the G8 environmental ministers, EPA has not 

undertaken an evaluation of its progress since 2002 or considered 

opportunities for a broader leadership role. The environmental ministers 

of the G8 countries declared that children’s environmental health was a 

shared priority among the eight countries at their meeting in Miami, 

Florida, in May 1997.63 They developed the Declaration of the 

Environmental Leaders of the Eight on Children’s Environmental Health

(Miami Declaration) that provided a framework for domestic, bilateral, 

and international actions by member nations to improve protection of 

children’s health from seven environmental threats. In 2002, the 

Government of Canada published a status report on the implementation of 

the Miami Declaration. Table 5 lists the seven issues and key 

commitments, along with a brief progress summary from Canada’s report. 

Notably, the status update for U.S. commitments on lead and air quality 

refer to two of the national strategies developed by the now-defunct 

President’s Task Force. 

 

63The G8 countries are Canada, France, Germany, Italy, Japan, Russia, the United Kingdom, 

the United States, as well as the European Commission. The most recent meeting of the G8 

took place in Italy in April 2009. 

Page 46 GAO-10-205 EPA Children’s Environmental Health 
 

Table 5: Summary of Commitments and U.S. Implementation of the 1997 Miami Declaration, as of 2002 

Children’s environmental 

health issue Key commitment Status update 

Risk assessment and standard 

setting 

“We pledge to establish national policies that take 

into account the specific exposure pathways and 

dose-response characteristics of children when 

conducting environmental risk assessments and 

setting protective standards.” 

Implementation of the Food Quality 

Protection Act requires an additional 10-

fold margin of safety for threshold effects 

Lead “We call for further actions that will result in reducing 

blood lead levels in children to below 10 micrograms 

per deciliter. Where this blood lead level is exceeded, 

further action is required.” 

Implementation of the federal Strategy to 

Eliminate Childhood Lead Poisoning by 

2010 

Microbiologically safe drinking 

water 

“We agree to focus increased attention on drinking 

water disinfection, source water protection and 

sanitation....” 

There are new final rules for 

Cryptosporidium and disinfection byproducts 

Air quality “We undertake to reduce air pollution in our 

respective countries. We agree to exchange 

information on indoor air health threats and remedial 

measures.” 

Implementation of Asthma and the 

Environment: An Action Plan to Protect 

Children 

Environmental tobacco smoke 

(ETS) 

“We agree to cooperate on education and public 

awareness efforts aimed at reducing children’s 

exposure to environmental tobacco smoke.” 

A new national public information campaign 

focuses on reducing at-risk children’s 

exposure to ETS and other indoor and 

outdoor asthma triggers 

Endocrine disrupting chemicals 

(EDC) 

“We encourage continuing efforts to compile an 

international inventory of research activities, develop 

an international science assessment...identify and 

prioritize research needs and data gaps, and develop 

a mechanism for coordinating and cooperating on 

filling research needs. We pledge to develop 

cooperatively risk management or pollution 

prevention strategies, as major sources and 

environmental fates of endocrine disrupting 

chemicals are identified and will continue to inform 

the public as new knowledge is gained.” 

The United States has a research program 

on EDCs and a screening program 

Climate change The declaration does not contain any specific 

commitments on this issue but recognized that 

“action must be taken to confront the problem of 

global warming” given that “children and future 

generations face serious threats to their health and 

welfare from changes in the Earth’s climate.” 

Global Change Research Program includes 

human health assessments 

Source: Excerpts from Government of Canada, Status Report on the Implementation of the 1997 Declaration of the Environment 

Leaders of the Eight on Children’s Environmental Health (2002). 

EPA has not undertaken an evaluation of its progress toward the country’s 

international commitments for children’s environmental health. Nor has 

the United States taken a leadership role in updating or reissuing specific 

new commitments since the 1997 declaration. At the April 2009 meeting of 

the G8, the EPA Administrator cited the declaration, highlighted 

Page 47 GAO-10-205 EPA Children’s Environmental Health 
 

subsequent U.S. activities, and provided examples of other countries’ 

actions—including Europe’s new chemicals policy and the World Health 

Organization’s Children’s Environment and Health Action Plan.64 The 

Administrator closed her remarks to the environmental ministers by 

stating, 

We have learned much in the last 12 years about the ways that environmental exposures 

uniquely affect children. With that increased knowledge, our sense of urgency for further 

action on children has also increased....The U.S. government, under this new 

administration, will keep faith with the promise we’ve made to future generations. I hope 

we can continue the work we started in 1997, renewing our commitment to protect 

children from environmental threats where they live, learn, work and play. 

Since the President signed Executive Order 13045 in 1997, every EPA 

Administrator has stated that children’s environmental health is a priority 

at the agency. However, the momentum seen in the goals, strategies, and 

accomplishments for children’s health that resulted from that initiative 

more than a decade ago has not been sustained through succeeding EPA 

administrators. Instead, we have seen diminished leadership, planning, 

and coordination at EPA and across the federal government with regard to 

children’s environmental health. In the intervening years, research has 

only further substantiated the importance that environmental exposures 

have during development—from before birth, through early childhood and 

adolescence, and into adulthood. The possibility that exposure to 

environmental contaminants may have lifelong health consequences for an 

individual person—and subsequent generations—is a paradigm shift in 

sophistication from the idea that “children are not just little adults,” an 

idea that was groundbreaking in the early 1990s. In order to continue 

making progress toward protecting children from environmental health 

threats, we believe EPA needs to reinvigorate its leadership and focus on 

children’s environmental health in concrete and actionable ways. 

Conclusions 

Notwithstanding the actions that EPA can take on its own, leadership from 

outside the agency will likely be needed for sustained progress toward 

protecting children from current and emerging environmental threats. As 

we stated in our testimony, the Children’s Health Protection Advisory 

Committee and the President’s Task Force on Children’s Environmental 

 

64Administrator Lisa P. Jackson, Remarks at the G8 Environmental Minister’s Meeting 

Children’s Health Event, April 24, 2009. 

Page 48 GAO-10-205 EPA Children’s Environmental Health 
 

Health Risks and Safety Risks have served as two such entities. The 

Advisory Committee has provided strategic, specific, and often unsolicited 

advice to EPA over the past decade. We continue to believe that EPA 

could do more to fully utilize that body of experts to inform EPA’s 

developing regulations and generally support the agency’s efforts to 

protect children’s health.65 Engaging the committee early and often in 

rulemakings and providing leadership in the area of science policy and 

other areas where EPA may lack conclusive information about children’s 

vulnerabilities would take advantage of the Advisory Committee’s 

expertise and reinvigorate its original purpose. The President’s Task Force 

that expired in 2005 provided high-level infrastructure to coordinate 

federal strategies for children’s environmental health and safety problems 

such as asthma, as well as data needs. Furthermore, the Task Force 

documented its accomplishments to the President in reports that detailed 

its members’ efforts to enhance the nation’s ability to understand, analyze, 

and respond to environmental health risks to children. EPA staff and 

children’s health experts told us the Task Force could help the federal 

government respond to national health and safety concerns, such as 

recalls of toys and other children’s products. Because the Task Force 

included nine cabinet officials and seven White House office directors and 

was co-chaired by the Administrator of EPA and the Secretary of Health 

and Human Services, it provided the leadership and authority needed to 

address children’s environmental health issues of national scope. We see 

opportunity for EPA to take a leadership role and identify, assess, and 

address the environmental health challenges of the 21st century such as 

low levels of toxic chemicals that may cause cancer and induce 

reproductive or developmental changes in the nation’s children. 

To help ensure that EPA assumes high-level leadership and develops 

strategies and structures for coordinating efforts addressing children’s 

environmental health both within the agency and throughout the federal 

government, we are making eight recommendations for executive action. 

Recommendations for 

Executive Action 

To maximize opportunities to institutionalize children’s health throughout 

the agency, we recommend that the EPA Administrator take the following 

actions: 

 

65GAO-08-1155T. 

Page 49 GAO-10-205 EPA Children’s Environmental Health 
 

• update and reissue a child-focused strategy, such as the 1996 National 

Agenda, to articulate current national environmental health priorities and 

emerging issues; 

• strengthen the data system that identifies and tracks development of 

rulemakings and other actions to ensure they comply with the 1995 policy 

on evaluating health risks to children; 

• re-evaluate the 1995 policy to ensure its consistency with new scientific 

research demonstrating the risks childhood exposures can have on risks 

for disease in later lifestages; 

• ensure that the EPA’s 2009-2014 strategic plan expressly articulates 

children-specific goals, objectives and targets; 

• re-evaluate the mission of the Office of Children’s Health Protection and 

its director to make the office an agencywide champion for 

implementation of a reissued national children’s environmental health 

agenda, policy, and related goals in the next EPA strategic plan; 

• establish key children’s environmental health staff within each program 

office and regional office, with linkages to the Office of Children’s Health, 

to improve cross-agency implementation of revised priorities and goals, 

and ensure coordination and communication among EPA’s program 

offices; 

• use the Children’s Health Protection Advisory Committee proactively as a 

mechanism for providing advice on regulations, programs, plans, or other 

issues; and 

• ensure participation, to the fullest extent possible, by the Office of 

Children’s Health or other key officials on the interagency organizations 

identified in Executive Order 13045. 

Because EPA alone cannot address the complexities of the nation’s 

challenges in addressing environmental health risks for children, we 

encourage Congress to re-establish a government-wide task force on 

children’s environmental health risks, similar to the one previously 

established by Executive Order 13045 and co-chaired by the Administrator 

of EPA and the Secretary of Health and Human Services. We encourage 

Congress to charge it with identifying the principal environmental health 

threats to children and developing national strategies for addressing them. 

We further encourage Congress to establish in law the Executive Order’s 

Matter for 

Congressional 

Consideration 

Page 50 GAO-10-205 EPA Children’s Environmental Health 
 

requirement for periodic reports about federal research findings and 

research needs regarding children’s environmental health. 

We provided EPA with a draft of this report for review and comment. EPA 

stated that the report accurately portrays the agency’s challenges in 

addressing children’s environmental health, and sets forth sound 

recommendations on steps that could be taken to better incorporate 

protection of children’s health as an integral part of EPA’s everyday 

business. EPA also commented that implementing the recommendations 

provided in this report will bring the agency a long way to achieving its 

goals for protecting children’s health. EPA’s written comments are in 

appendix V. In addition, EPA provided technical comments, which we 

incorporated into the report as appropriate. 

Agency Comments 

and Our Evaluation 

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from its 

issuance. At that time, we will send copies of this report to interested 

congressional committees, the Administrator of the Environmental 

Protection Agency, and other interested parties. The report also will be 

available at no charge on GAO’s Web site at http://www.gao.gov. 

If you or your staffs have any questions about this report, please contact 

me at (202) 512-3841 or stephensonj@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on the 

last page of this report. GAO staff who made major contributions to this 

John B. Stephenson 

report are listed in appendix VI. 

Director, Natural Resources 

 and Environment 

Page 51 GAO-10-205 EPA Children’s Environmental Health 
Appendix I: Scope and Methodology Appendix I: Scope and Methodology 

Our report objectives were to examine (1) the extent to which the 

Environmental Protection Agency’s (EPA) policies, plans, and guidance 

have served to institutionalize the agency’s consideration of children’s 

environmental health; (2) the extent to which EPA has utilized its 

children’s health office and other child-focused resources; and (3) what 

opportunities exist for EPA to provide national leadership in addressing 

current and emerging environmental risks to children’s health. 

To address our first objective, we obtained and analyzed key EPA 

children’s health-related policies, strategic and performance plans, 

guidance documents, and selected children’s indicator reports, and 

referred to long-established quality management criteria from the 

Government Performance Results Act. We considered EPA’s “2006-2011 

Strategic Plan: Charting Our Course,” “2003-2008 Strategic Plan: Direction 

for the Future,” “EPA Strategic Plan: 2000-2005,” “EPA Strategic Plan: 

1997-2003,” as well as EPA’s forthcoming strategic plan, “2009-2014

Strategic Plan: Change Document,” which was in draft form at the time of 

our review. We analyzed the goals, objectives, and strategic targets of 

these documents in order to determine the extent that they address 

children’s health. We reviewed EPA’s performance and accountability 

reports to identify performance measures associated with identified 

children’s health objectives and strategic targets. We discussed the plans 

and reports with officials from EPA’s Office of the Chief Financial Officer, 

including staff from the Office of Planning, Analysis, and Accountability. 

We also reviewed OMB Circular No. A-11 on guidance to agencies 

preparing materials required for strategic plans and annual program 

performance reports. We reviewed EPA Federal Register notices for 

regulations subject to the regulatory requirements of the order as well as 

documents detailing EPA’s rulemaking for its National Ambient Air Quality 

Standards for Particulate Matter published in October 2006. We also 

reviewed children’s health data that EPA maintains in its regulatory 

tracking database. 

To address our second objective, we used NVivo, a content analysis 

software package, to analyze 35 Advisory Committee meeting agendas and 

related summaries derived from meetings held bi- or tri-annually between 

December 1997 and July 2009. Content analysis is a methodology for 

structuring and analyzing written material. We also used the software to 

analyze 74 Children’s Health Protection Advisory Committee (Advisory 

Committee) letters sent to EPA and 53 EPA response letters, issued 

between May 1998 and December 2008. Our internal team of subject 

matter and methodological experts developed a coding scheme for 

identifying (1) recommendations, which we defined as any and all 

Page 52 GAO-10-205 EPA Children’s Environmental Health 
Appendix I: Scope and Methodology 

statements made in Advisory Committee letters that advise, ask, request, 

suggest, or urge EPA to take action; and (2) EPA requests of the Advisory 

Committee, which we defined as formal or incidental requests for advice 

or input by EPA to its Advisory Committee. Recommendations were 

identified in Advisory Committee letters sent to EPA. In some cases, a 

single sentence contained multiple recommendations. For example, the 

Advisory Committee wrote “EPA should show leadership in applying 

stringent mercury controls in our own coal-fired power plants and involve 

the U.S. in technology transfer to improve emissions in other parts of the 

world,” which we coded as two recommendations. EPA requests of the 

Advisory Committee were identified in meeting summaries, which 

represent the official and complete record of proceedings. Other 

requests—for example, individually from an EPA official to an individual 

Advisory Committee member—were not considered requests as the entire 

Advisory Committee must be informed and consensus must be reached by 

the Advisory Committee on all matters, as specified in its charter. 

To characterize the range of issues recommended to EPA by its Advisory 

Committee, we developed content analysis categories based on a review of 

the Advisory Committee’s charter and an initial review of the letters. We 

then coded each recommendation into one or more of the following 10 

categories: 

• budget and resources (financing, funding, or the need to change resource 

levels for a program or issue), 

• education and public awareness (providing information to the public 

through different media outlets), 

• organization and processes (how EPA is organized, including how it 

operates, the form or function of EPA management, and its internal 

processes and procedures), 

• policies and priorities (advising EPA to amend, go forward with, or cease a 

particular policy or prioritization that directly or indirectly may impact 

children’s health), 

• external partnership and inter-agency coordination (how EPA coordinates 

or collaborates with other agencies or entities), 

• guidance (developing, updating and using guidance documents and related 

information resources), 

Page 53 GAO-10-205 EPA Children’s Environmental Health 
Appendix I: Scope and Methodology 

• regulations and standards (EPA regulations and its work setting or 

influencing EPA or government-wide standards), 

• research (conducting, funding, utilizing, or prioritizing research that would 

benefit children’s health), 

• risk assessment (development of risk assessment protocols, and selecting 

assumptions, risk factors, and margins of error), and 

• tracking and indicators (tracking environmental pollutants, as well as 

monitoring such pollutants and/or observing human health outcomes over 

time). 

The content analysis was conducted by two analysts, and discrepancies in 

coding were discussed and agreement reached between the analysts, or 

resolved through a third analyst review. Our analysis produced an 

inventory of Advisory Committee recommendations and EPA requests of 

the Advisory Committee. 

We also interviewed officials from EPA program offices most directly 

involved with children’s health issues: the Office of Children’s Health 

Protection, including current and former office directors; the Office of 

Research and Development; the Office of Pesticide Programs; and the 

Office of Policy, Economics and Innovation. We interviewed EPA’s 

regional children’s environmental health coordinators and lead regional 

coordinator within the Office of the Administrator. To gain further 

perspective on EPA’s use of its children’s health-focused resources, we 

interviewed leading children’s health research and policy experts at 

nonprofit organizations and academic institutions, including those 

associated with EPA’s Advisory Committee. 

To address our third objective, we reviewed the annual reports from the 

Federal Interagency Forum on Child and Family Statistics to determine the 

extent of EPA’s involvement in their development. We also interviewed 

staff involved with the children’s task force and reviewed documents from 

the Task Force on Environmental Health Risks and Safety Risks to 

Children, including the strategy documents that were developed. We also 

reviewed documents related to the G8 Miami Declaration on Children’s 

Environmental Health, including the 2002 Status Report on 

Implementation of the 1997 Declaration of the Environmental Leaders of 

the Eight on Children’s Environmental Health. 

Page 54 GAO-10-205 EPA Children’s Environmental Health 
Appendix I: Scope and Methodology 

We conducted this performance audit from November 2008 through 

January 2010 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives. 

Page 55 GAO-10-205 EPA Children’s Environmental Health 
Appendix II: EPA Policy on Evaluating Health Appendix II: EPA Policy on Evaluating Health Risks to Children 

Risks to Children 

Page 56 GAO-10-205 EPA Children’s Environmental Health 
Appendix II: EPA Policy on Evaluating Health 

Risks to Children 

Page 57 GAO-10-205 EPA Children’s Environmental Health 
Appendix II: EPA Policy on Evaluating Health 

Risks to Children 

Page 58 GAO-10-205 EPA Children’s Environmental Health 
Appendix III: Executive Order 13045 and Appendix III: Executive Order 13045 and Amendments 

Amendments 

Page 59 GAO-10-205 EPA Children’s Environmental Health 
Appendix III: Executive Order 13045 and 

Amendments 

Page 60 GAO-10-205 EPA Children’s Environmental Health 
Appendix III: Executive Order 13045 and 

Amendments 

Page 61 GAO-10-205 EPA Children’s Environmental Health 
Appendix III: Executive Order 13045 and 

Amendments 

Page 62 GAO-10-205 EPA Children’s Environmental Health 
Appendix III: Executive Order 13045 and 

Amendments 

Page 63 GAO-10-205 EPA Children’s Environmental Health 
Appendix III: Executive Order 13045 and 

Amendments 

Page 64 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to Appendix IV: EPA Regulations Subject to Executive Order 13045 

Executive Order 13045 

Executive Order 13045—Protection of Children from Environmental 

Health Risks and Safety Risks (Executive Order)—requires that federal 

agencies provide, to the Office of Management and Budget (OMB) and in 

the public record, (1) an evaluation of the environmental health or safety 

effects of the planned regulation on children, and (2) an explanation of 

why the planned regulation is preferable to other potentially effective and 

reasonably feasible alternatives considered by the agency.1

 Table 6 

summarizes the Federal Register notice preamble section pertaining to the 

Executive Order for each of the EPA regulations subject to the Executive 

Order. The table’s columns show (1) the office that initiated the 

rulemaking; (2) whether a given regulation was final or proposed, and its 

Federal Register citation; (3) the children’s environmental health 

concern(s) EPA identified; and (4 and 5) summaries of how EPA 

described, in the preamble, its analyses pursuant to the two regulatory 

requirements of the Executive Order. The table indicates with an arrow 

(«) when EPA explicitly directed readers to additional information in the 

body of the rulemaking or the public docket. The table also indicates with 

a star (+) when EPA either quantified the effects on children of the 

regulation or other regulatory options, or explained why it did not do so. 

We identified 17 rulemakings since 1998 that EPA determined were subject 

to the Executive Order’s requirements. For each of those regulations, we 

analyzed whether and how EPA discussed how it met the order’s 

requirements in the notice’s preamble. We found that EPA has not 

consistently documented therein how its rulemakings considered 

children’s environmental health risks. Specifically, we found that, for only 

4 of the rulemakings did EPA either quantify the effects of the rulemaking 

on children or explain why it did not, or could not, do so. For 8 of the 

rulemakings, EPA explicitly directed the reader—with varying degrees of 

specificity—to additional information about the regulation’s effect on 

children. 

 

1

These requirements are provided in Executive Order 13045 section 501(a) and 501(b), 

respectively. 

Page 65 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

Table 6: EPA Regulations Subject to Executive Order 13045 

EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

1 National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule 

Water Final 

71 Fed. Reg. 654 

(Jan. 5, 2006). 

Cryptosporidiosis from 

exposure to Cryptosporidium 

in drinking water. 

Common symptoms include 

diarrhea and vomiting. EPA 

described studies on 

children’s unique 

susceptibilities and 

exposures to 

Cryptosporidium and 

analyzed data on the 

number of Cryptosporidium 

cases in 1999, by age. 

EPA stated that the planned 

regulation will reduce the risk 

of illness for the entire 

population, including children. 

Because children may be 

disproportionately affected, 

the regulation may result in 

greater risk reduction for 

children. Existing data are not 

adequate to assess children’s 

risks. 

EPA briefly described 

other regulatory options it 

considered and stated that 

the planned regulation 

was selected because it 

was deemed feasible and 

provided significant public 

health benefits in terms of 

avoided illnesses and 

deaths. EPA’s analysis 

indicated that the planned 

regulation ranks highly 

among those evaluated 

with respect to maximizing 

net benefits. 

« « + «

Proposed 

68 Fed. Reg. 

47,640 (Aug. 11, 

2003). 

Same Same Same 

« « + «

2 National Pollutant Discharge Elimination System Permit Regulation and Effluent Limitation Guidelines and Standards 

for Concentrated Animal Feeding Operations (CAFO) 

Water Final 

68 Fed. Reg. 

7,176 (Feb. 12, 

2003). 

Infants under 6 months may 

be at risk of 

methemoglobinemia from 

exposure to nitrates in 

private drinking-water wells. 

EPA estimated that 112,000 

households would have their 

nitrate levels brought to levels 

that are safe for infants. EPA 

did not have information on 

the number of infants living in 

those households. 

EPA estimated that more 

stringent options would 

provide only small 

changes in pollutant 

loadings to groundwater, 

such that more stringent 

options would not provide 

meaningful protection of 

children’s health risks from 

methemoglobinemia. 

« « + «

Page 66 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

 EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

Proposed 

66 Fed. Reg. 

2,960 (Jan. 12, 

2001). 

Same 

In addition, EPA stated that 

information was not 

available on the actual 

number of cases of 

methemoglobinemia. 

Furthermore, EPA noted that 

the following pollutants may 

also have a disproportionate 

risk to children: pathogens; 

trace metals such as zinc, 

arsenic, copper, and 

selenium; pesticides; 

hormones; and endocrine 

disruptors. However, EPA 

did not have adequate 

information to assess the 

risks to children. 

EPA estimated the number of 

households that would have 

their nitrate levels brought to 

levels that are safe for infants 

at 166,000 households under 

the two-tier structure; and 

161,000 households under 

the three-tier structure. 

Same 

« « + «

3 National Ambient Air Quality Standards for Lead 

Air and Radiation Final 

73 Fed. Reg. 

66,964 (Nov. 12, 

2008). 

Neurological effects from 

childhood exposure to lead. 

EPA stated that the standards 

were designed to protect public 

health with an adequate margin 

of safety, as required by the 

Clean Air Act, and that the 

protection offered by the 

standards may be especially 

important for children. 

Not explicitly addressed 

«

Proposed 

73 Fed. Reg. 

29,184 (May 20, 

2008). 

Same Same Same 

«

4 Control of Emissions of Air Pollution From Locomotive Engines and Marine Compression-Ignition Engines Less Than 

30 Liters per Cylindera

Air and Radiation Final 

73 Fed. Reg. 

25,098 (May 6, 

2008). 

Not specified 

EPA stated that children 

appeared to be 

overrepresented for some 

individual facilities, based on 

initial screening conducted 

by the agency and described 

in this section. 

EPA stated that the 

rulemaking would achieve 

significant reductions of 

various emissions from 

locomotive and marine diesel 

engines, and that the 

regulation would benefit 

children. 

EPA stated that it had 

evaluated several 

regulatory strategies and 

selected the most 

stringent and effective 

control reasonably 

feasible, in light of the 

technology and cost 

requirements of the Clean 

Air Act. 

« «

Page 67 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

 EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

5 National Ambient Air Quality Standards for Ozone

Air and Radiation Final 

73 Fed. Reg. 

16,436 (Mar. 27, 

2008). 

Not specified Not explicitly addressed Not explicitly addressed 

«

Proposed 

72 Fed. Reg. 

37,818 (Jul. 11, 

2007). 

Same EPA stated that the standards 

were designed to protect 

public health with an 

adequate margin of safety, as 

required by the Clean Air Act, 

and that the protection offered 

by the standards may be 

especially important for 

children. 

Same 

«

6 Control of Hazardous Air Pollutants From Mobile Sources

Air and Radiation Final 

72 Fed. Reg. 

8,428 (Feb. 26, 

2007). 

Cancer and respiratory 

problems from exposure to 

hazardous air pollutants 

from mobile sources, 

including particulate matter. 

Not explicitly addressed Not explicitly addressed 

«

Proposed 

71 Fed. Reg. 

15,804 (Mar. 29, 

2006). 

Same EPA stated that the regulation 

may have a disproportionately 

beneficial effect on children. 

Same 

«

7 Clean Air Fine Particle Implementation Ruleb

Air and Radiation Final 

72 Fed. Reg. 

20,586 (Apr. 25, 

2007). 

Not specified EPA stated that the standards 

implemented the previously 

promulgated National 

Ambient Air Quality 

Standards (NAAQS) for fine 

particulate matter, which were 

designed to protect public 

health with an adequate 

margin of safety, as required 

by the Clean Air Act, and that 

the protections offered by the 

standards may be especially 

important for children. 

Not explicitly addressed 

«

Page 68 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

 EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

8 National Ambient Air Quality Standards for Particulate Matter

Air and Radiation Final 

71 Fed. Reg. 

61,144 (Oct. 17, 

2006). 

Not specified EPA stated that the standards 

were designed to protect 

public health with an 

adequate margin of safety, as 

required by the Clean Air Act, 

and that the protection offered 

by the standards may be 

especially important for 

children. 

Not explicitly addressed 

«

Proposed 

71 Fed. Reg. 

2,620 (Jan. 17, 

2006). 

Same Same Same 

«

9 Standards of Performance for New and Existing Stationary Sources: Electric Utility Steam Generating Units

Air and Radiation Final 

70 Fed. Reg. 

28,606 (May 18, 

2005). 

Neurodevelopmental effects 

to developing fetuses from 

exposure to methylmercury. 

EPA stated that the regulation 

would help reduce exposure 

of women of childbearing age 

to methylmercury, and 

estimated the number of 

children who will be exposed 

to methylmercury in 2020. 

EPA estimated how IQ 

decrements would be 

reduced as a result of the 

regulation. 

EPA also discussed 

limitations of the regulation to 

affect human health. 

EPA stated the selected 

option delivered about the 

same amount of benefits 

as other regulatory 

alternatives it considered, 

but at a lower cost. 

« « +

Proposed 

69 Fed. Reg. 

4,652 (Jan. 30, 

2004). 

Not specified EPA stated that the strategies 

proposed in this rulemaking 

would improve air quality and 

children’s health. 

Not explicitly addressed 

«

10 Revision of December 2000 Clean Air Act Section 112(n) Finding Regarding Electric Utility Steam Generating Units; and 

Standards of Performance for New and Existing Electric Utility Steam Generating Units: Reconsiderationc

Air and Radiation Final 

71 Fed. Reg. 

33,388 (Jun. 9, 

2006). 

Not specified EPA explained that it had 

evaluated the environmental 

health or safety effects to 

children of its Clean Air 

Mercury Rule. 

Not explicitly addressed 

«

Page 69 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

 EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

11 Control of Air Pollution from New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards and Highway Diesel Fuel 

Sulfur Control Requirements

Air and Radiation Final 

66 Fed. Reg. 

5,002 (Jan. 18, 

2001). 

Not specified 

EPA noted that some of 

pollutants addressed in the 

regulation may 

disproportionately affect 

children’s health, such as 

ozone, particulate matter 

and certain toxic air 

pollutants. 

EPA stated that the 

rulemaking would reduce air 

toxics and the related impacts 

on children’s health. 

Explained that EPA had 

addressed the effect on 

children of exposure to ozone 

and particulate matter in its 

rulemakings to establish the 

NAAQS for those pollutants, 

and that it was not revisiting 

those here. 

EPA stated that, 

consistent with the Clean 

Air Act, the planned 

regulation was designed 

to achieve the greatest 

degree of reduction of 

emissions achievable 

through available 

technology, taking cost 

and other factors into 

consideration. 

« « «

Proposed 

65 Fed. Reg. 

35,430 (June 2, 

2000). 

Same Same Same 

« « «

12 Control of Emissions of Air Pollution from 2004 and Later Model Year Heavy-Duty Highway Engines and Vehicles; 

Revision of Light-Duty On-Board Diagnostics Requirements

Air and Radiation Final 

65 Fed. Reg. 

59,896 (Oct. 6, 

2000). 

Not specified 

EPA noted that some 

pollutants addressed in the 

regulation may 

disproportionately affect 

children’s health, such as 

ozone, particulate matter 

and certain toxic air 

pollutants. 

EPA stated that the 

rulemaking would reduce air 

toxics and the related impacts 

on children’s health. 

Explained that EPA had 

addressed the effect on 

children of exposure to ozone 

and particulate matter in its 

rulemakings to establish the 

NAAQS for those pollutants, 

and that it was not revisiting 

those here. 

EPA stated that, 

consistent with the Clean 

Air Act, the planned 

regulation was designed 

to achieve the greatest 

degree of reduction of 

emissions achievable 

through available 

technology, taking cost 

and other factors into 

consideration. 

« « «

Proposed 

64 Fed. Reg. 

58,472 (Oct. 29, 

1999). 

Same Same Same 

« « «

Page 70 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

 EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

13 Control of Air Pollution From New Motor Vehicles: Tier 2 Motor Vehicle Emissions Standards and Gasoline Sulfur 

Control Requirements

Air and Radiation Final 

65 Fed. Reg. 

6,698 (Feb. 10, 

2000). 

Not specified 

EPA noted that some of 

pollutants addressed in the 

regulation may 

disproportionately affect 

children’s health, such as 

ozone, particulate matter 

and certain toxic air 

pollutants. 

EPA stated that the 

rulemaking would reduce air 

toxics and the related impacts 

on children’s health. 

Explained that EPA had 

addressed the effect on 

children of exposure to ozone 

and particulate matter in its 

rulemakings to establish the 

NAAQS for those pollutants, 

and that it was not revisiting 

those here. 

EPA stated that the 

planned regulation was 

the most stringent and 

effective control 

reasonably feasible at the 

time, in light of the 

technology and cost 

requirements of the Clean 

Air Act. 

« « «

Proposed 

64 Fed. Reg. 

26,004 (May 13, 

1999). 

Same Same Same 

« « «

14 Lead; Renovation, Repair, and Painting Program

Prevention, 

Pesticides, and 

Toxic 

Substances 

Final 

73 Fed. Reg. 

21,692 (Apr. 22, 

2008). 

Not specified EPA stated that the primary 

purpose of the regulation was 

to minimize exposure in 

children under age 6 to leadbased paint hazards created 

during renovation, repair, and 

painting activities in housing 

or other buildings. Estimated 

that the regulation would 

affect 1.4 million children 

under age 6, providing 

considerable benefits to those 

children. 

Not explicitly addressed 

« +

Proposed 

71 Fed. Reg. 

1,588 (Jan. 10, 

2006). 

Same EPA stated that one purpose 

of the proposed regulation 

was to prevent the creation of 

new lead-based paint hazards 

from housing where children 

under age 6 reside. Estimated 

that the regulation would 

affect 1.1 million children 

under age 6, providing 

considerable benefits to those 

children. 

Same 

« +

Page 71 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

 EPA office 

Type of 

regulation (date) 

Children’s environmental 

health concern 

Effect on children of 

planned regulation 

Why regulation is 

preferable to other 

options 

15 Lead and Lead Compounds; Lowering of Reporting Thresholds; Community Right-to-Know Toxic Chemical Release 

Reporting 

Prevention, 

Pesticides, and 

Toxic 

Substances 

Final 

66 Fed. Reg. 

4,500 (Jan. 17, 

2001). 

Not specified 

EPA stated that it identified 

and assessed the 

environmental health risks 

and safety risks that may 

disproportionately affect 

children. 

EPA described how the 

informational benefits of the 

planned regulation could 

positively impact children and 

other populations. 

Not explicitly addressed 

Proposed 

64 Fed. Reg. 

42,222 (Aug. 3, 

1999). 

Same Same Same 

16 Lead; Identification of Dangerous Levels of Lead

Prevention, 

Pesticides, and 

Toxic 

Substances 

Final 

66 Fed. Reg. 

1,206 (Jan. 5, 

2001). 

Not specified EPA stated that the selected 

standards were designed first 

and foremost to protect 

children from lead in 

residential paint, dust, and 

soil. 

EPA stated that it could 

have selected numerically 

more stringent standards, 

but concluded that they 

would provide less 

protection to children 

because limited resources 

would be diluted and 

possibly diverted away 

from children at greatest 

risk. 

«

Proposed 

63 Fed. Reg. 

30,302 (Jun. 3, 

1998). 

Same EPA stated that young 

children were the primary 

beneficiaries of the proposed 

regulation because exposure 

to lead, paint, and dust is 

mostly limited to children 

under the age of 6. 

Not explicitly addressed 

«

17 Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering of Reporting Thresholds for Certain PBT Chemicals; 

Addition of Certain PBT Chemicals; Community Right-to-Know Toxic Chemical Reporting

Prevention, 

Pesticides, and 

Toxic 

Substances 

Final 

64 Fed. Reg. 

58,666 (Oct. 29, 

1999). 

Not explicitly addressed EPA described how the 

informational benefits of the 

rule could positively impact 

children and other 

populations. 

Not explicitly addressed 

Proposed 

64 Fed. Reg. 688 

(Jan. 5, 1999). 

Same Same Same 

Source: GAO analysis of Federal Register notices’ preamble sections. 

Page 72 GAO-10-205 EPA Children’s Environmental Health 
Appendix IV: EPA Regulations Subject to 

Executive Order 13045 

Notes: 

The table indicates with an arrow («) when EPA explicitly directed readers to additional information in 

the body of the rulemaking or the public docket. The table also indicates with a star (+) when EPA 

either quantified the effects on children of the regulation or other regulatory options, or explained why 

it did not do so. 

a

EPA determined that the proposed regulation, published April 3, 2007, was not subject to Executive 

Order 13045 because the agency did not have reason to believe that the environmental health risks 

or safety risks addressed by the regulation presented a disproportionate risk to children. 

b

EPA determined that the proposed regulation, published November 1, 2005, was not subject to 

Executive Order 13045. EPA did not explicitly state in its Federal Register notice why the regulation 

was not subject to the order. 

c

This regulation sets forth EPA’s decision after reconsidering certain aspects of the March 29, 2005, 

final rule entitled “Revision of December 2000 Regulatory Finding on the Emissions of Hazardous Air 

Pollutants From Electric Utility Steam Generating Units and the Removal of Coal- and Oil-Fired 

Electric Utility Steam Generating Units from the Section 112(c) List” (Section 112(n) Revision Rule). 

The regulation also includes EPA’s final decision regarding reconsideration of certain issues in the 

May 18, 2005, final rule entitled “Standards of Performance for New and Existing Stationary Sources: 

Electric Utility Steam Generating Units” (Clean Air Mercury Rule; CAMR), which was subject to 

Executive Order 13045. 

Page 73 GAO-10-205 EPA Children’s Environmental Health 
Appendix V: Comments from the Appendix V: Comments from the Environmental Protection Agency 

Environmental Protection Agency 

Page 74 GAO-10-205 EPA Children’s Environmental Health 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 75 GAO-10-205 EPA Children’s Environmental Health 
Appendix V: Comments from the 

Environmental Protection Agency 

Page 76 GAO-10-205 EPA Children’s Environmental Health 
Appendix VI: 

A

GAO Contact and Staff 

cknowledgments 

Page 77 GAO-10-205 EPA Children’s Environmental Health 

Appendix VI: GAO Contact and Staff 

Acknowledgments 

John Stephenson, (202) 512-3841 or stephensonj@gao.gov

In addition to the contact named above, Diane Raynes, Assistant Director; 

Elizabeth Beardsley; Timothy Bober; Mark Braza; Emily Hanawalt; 

Terrance Horner, Jr.; Aaron Shiffrin; Benjamin Shouse; and Kiki 

Theodoropoulos made key contributions to this report. 

GAO Contact 

Staff 

Acknowledgments 

(361022) 
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