ENVIRONMENTAL 

HEALTH

EPA Has Made 

Substantial Progress 

but Could Improve 

Processes for 

Considering 

Children’s Health

Report to the Chairman, Committee on 

Environment and Public Works, 

U.S. Senate

August 2013

GAO-13-254

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-13-254, a report to the 

Chairman, Committee on Environment and 

Public Works, U.S. Senate

August 2013

ENVIRONMENTAL HEALTH

EPA Has Made Substantial Progress but Could 

Improve Processes for Considering Children's Health

Why GAO Did This Study

Scientific studies have shown that 

because children’s bodies are still 

developing, they can be more 

vulnerable than adults to certain 

environmental hazards, including air 

pollutants, pesticide residues on food, 

contaminants in drinking water, and 

toxic chemicals in the home. EPA has 

made protecting children’s health part 

of its mission by establishing a policy in 

1995 to ensure that the agency 

consistently considers children in its 

actions and creating OCHP to support 

those efforts. In a 2010 report, GAO 

found that EPA had not fully utilized 

OCHP and other child-focused 

resources to protect children’s health. 

GAO was asked to review EPA’s 

progress in protecting children’s health. 

This report determines (1) the extent to 

which EPA has implemented GAO’s 

2010 recommendations on children’s 

health protection and (2) the role, if 

any, that OCHP has played in ensuring 

that key EPA program offices consider 

children’s health protection in their 

regulatory activities. The report also 

describes how OCHP has worked with 

external partners to leverage its 

resources. To conduct this work, GAO 

reviewed relevant laws and EPA 

regulations and guidance, analyzed 

EPA data, and interviewed EPA 

officials and other stakeholders. 

What GAO Recommends

GAO recommends, among other 

things, that EPA direct OCHP and OPP 

to establish procedures to identify 

those tolerance decisions that could 

pose a significant risk to children’s 

health and provide opportunities for 

OCHP involvement when appropriate. 

EPA generally agreed with GAO.

What GAO Found

The Environmental Protection Agency (EPA) has made substantial progress in 

addressing more than half of the recommendations GAO made in a January 

2010 report concerning the agency’s efforts to protect children’s health. 

Specifically, EPA has fully implemented five of the eight recommendations made 

by GAO. For example, for a recommendation that EPA ensure that its strategic 

plan expressly articulate children-specific goals, objectives, and targets, in 

September 2010, EPA issued an agency-wide strategic plan that identifies 

children’s health as a top agency priority with goals, objectives, and targets. In 

addition, EPA took some steps to address the remaining three recommendations 

from GAO’s January 2010 report but has not fully implemented them, including a 

recommendation that the agency 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. 

The Office of Children’s Health Protection (OCHP) has increased its role to 

ensure that EPA program offices consider children’s health protection in their 

regulatory activities. Specifically, the EPA Administrator issued a memorandum 

in February 2010 directing OCHP to take the lead in ensuring that all EPA 

programs are successful in their efforts to protect children’s health. Since the 

issuance of the memorandum and the office’s reorganization in July 2010, OCHP 

has played a greater supporting role in program offices’ development of selected 

regulations that potentially affect children’s health. However, OCHP has no 

regular involvement in the Office of Pesticide Program’s (OPP) decision-making 

process addressing tolerances for pesticide residues. In addition, OCHP officials 

may not be aware of these decisions, and there are no mechanisms in the 

tolerance setting process to alert OCHP when matters that could pose a 

significant risk to children’s health are being considered. Until the disconnect 

between the direction identified for OCHP in the Administrator’s memorandum 

and the current process is addressed, OCHP will not have a role to ensure that 

children’s health protection is considered in the area of pesticide tolerance 

decisions. 

OCHP has worked extensively with a variety of partners to leverage its resources 

to better protect children’s health. Through its coordination with federal partners, 

OCHP has helped to improve children’s environmental health in schools and 

homes. For example, training courses for about 800 participants through the 

National Center for Healthy Housing are being offered around the country 

addressing topics such as pest management and energy efficiency. In addition, 

OCHP has financially supported children’s health efforts in underserved 

communities across the country by providing grants totaling $1.2 million. For 

example, OCHP awarded a $100,000 grant to Farm Worker Justice, a group 

which provides outreach and educational activities for families of farm workers to 

improve the environmental health of their children. OCHP has also worked with 

Pediatric Environmental Health Specialty Units (PEHSU) to help train 15,000 

health care providers across the country about the health implications of prenatal 

and childhood environmental exposures. PEHSUs also work with federal, state 

and local agencies to address children’s environmental health issues in homes, 

schools, and communities.

View GAO-13-254. For more information, 

contact David C. Trimble at (202) 512-3841 or 

trimbled@gao.gov.
Page i GAO-13-254 EPA Children's Health

Letter 1 

Background 6

EPA Has Made Substantial Progress in Addressing More than Half 

of Our 2010 Recommendations 17

OCHP Has Increased Its Role to Ensure That Most EPA Program 

Offices Consider Children’s Health Protection in Their 

Regulatory Activities 30

OCHP Has Worked with External Partners to Leverage Its 

Resources to Better Protect Children’s Health 44

Conclusions 50

Recommendations for Executive Action 52

Agency Comments and Our Evaluation 53

Appendix I Objectives, Scope, and Methodology 55

Appendix II EPA Policy on Evaluating Health Risks to Children 58

Appendix III EPA Administrator’s February 2010 Memorandum 61

Appendix IV Office of Children’s Health Protection’s Involvement in 

Agency Actions in Fiscal Year 2011 63

Appendix V FQPA Tolerance Decisions by OPP for Fiscal Year 2011 65

Appendix VI Comments from the Environmental Protection Agency 66

Appendix VII GAO Contact and Staff Acknowledgments 71

Contents 
Page ii GAO-13-254 EPA Children's Health

Table

Table 1: Agency Actions Addressing Children’s Health in Fiscal 

Year 2011 63

Figures

Figure 1: Steps Where Children Are Considered in the EPA 

Rulemaking Process 16

Figure 2: Implementation Status of GAO’s 2010 Recommendations 18

Figure 3: Questions Used to Help Identity Actions Potentially 

Involving Children’s Health 25

Figure 4: EPA Summary of Pesticides with Safety Factor Decisions 

from 1996 to 2012 38

Figure 5: Services Provided by Pediatric Environmental Health 

Specialty Units 49
Page iii GAO-13-254 EPA Children's Health

Abbreviations

ADP Action Development Process

CBI confidential business information

CDC Centers for Disease Control and Prevention

CHPAC Children’s Health Protection Advisory Committee

DFO Designated Federal Officer

EPA Environmental Protection Agency

FACA Federal Advisory Committee Act

Forum Federal Interagency Forum on Child and Family Statistics

FQPA Food Quality Protection Act of 1996

FTE full-time equivalent

HHS Department of Health and Human Services

IG Inspector General

LOAEL Lowest observed adverse effect level

National National Agenda to Protect Children’s Health from

 Agenda Environmental Threats

NRDC Natural Resources Defense Council

OCHP Office of Children’s Health Protection

OPP Office of Pesticide Programs

PEHSU Pediatric Environmental Health Specialty Unit

SDWA Safe Drinking Water Act Amendments of 1996

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

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necessary if you wish to reproduce this material separately.
Page 1 GAO-13-254 EPA Children's Health

441 G St. N.W.

Washington, DC 20548

August 12, 2013

The Honorable Barbara Boxer

Chairman

Committee on Environment and Public Works

United States Senate

Dear Madam Chairman:

Scientific studies have shown that because children’s bodies are still 

developing, they can be more vulnerable than adults to certain 

environmental hazards, including air pollutants, pesticide residues on 

food, contaminants in drinking water, and toxic chemicals found in the 

home.1 Children’s vulnerability to environmental hazards may also stem 

from their behavior, which can expose them to such hazards. For 

example, air pollutants such as ozone that may produce serious 

complications in children and adults with lung diseases, including asthma, 

may be more likely to affect children, in part because their airways and 

lungs are still developing and they spend more time outdoors.

2

Additionally, children’s exposure to some chemical hazards may be 

greater than adults’ because infants and young children engage in more 

hand-to-mouth behavior, and spend more time on the floor, where some 

of these hazards (e.g., lead dust) are more likely to be.3 According to a 

 

1

M. Herrmann, K. King, and M. Weitzman. “Prenatal Tobacco Smoke and Postnatal 

Secondhand Smoke Exposure and Child Neurodevelopment,” Current Opinion in 

Pediatrics 20, no. 2 (2008):184-190. B. Weiss and D.C. Bellinger, “Social Ecology of 

Children’s Vulnerability to Environmental Pollutants,” Environmental Health Perspectives

114, no. 10 (2006): 1,479-1,485.

2

Approximately 7 million children in the United States have asthma, according to the 

President’s Task Force on Environmental Health Risks and Safety Risks to Children, and 

asthma accounted for 10.5 million missed school days in 2008. L.J. Akinbami, J.E. 

Mooreman, C. Bailey, H. Zahran, M. King, C. Johnson, & X. Liu. Centers for Disease 

Control and Prevention, National Center for Health Statistics (2012). “Trends in Asthma 

Prevalence, Health Care Use, and Mortality in the United States, 2001-2010.” Retrieved 

from http://www.cdc. gov/nchs/data/databriefs/db94.pdf. 

3

Children are particularly susceptible to accidental poisoning because they tend to play on 

floors and explore by putting items in their mouths. EPA takes action to address such 

hazards. For example, in February 2013, EPA initiated a regulatory action to cancel and 

remove from the consumer market 12 D-Con brand mouse and rat poison bait products. 

At the manufacturer’s request, EPA will hold a pesticide cancellation hearing which will 

determine whether a final cancellation notice will be issued. Documentation is available in 

docket EPA-HQ-OPP-2013-0049 at www.regulations.gov. 

 
 

Page 2 GAO-13-254 EPA Children's Health

January 2012 report from the Department of Health and Human Service’s 

Centers for Disease Control and Prevention (CDC),4 approximately 

450,000 children in the United States have elevated levels of lead in their 

blood, and lead exposure may cause learning disabilities or health 

problems in their cardiovascular, immunological, and endocrine systems.5

Relative to their body weight, children also breathe more air, drink more 

water, and consume more food than adults. Ongoing research continues 

to increase our understanding of children’s vulnerabilities. Studies have 

also shown that early life exposures to environmental hazards may 

increase risk of some diseases later on in life. For example, several 

studies have reported associations between exposure to harmful 

contaminants in early life and adverse health effects such as 

neurodevelopmental disorders.6 According to the Environmental 

Protection Agency’s (EPA) January 2013 America’s Children and 

Environment report, childhood leukemia, in particular, has been 

associated with exposures to pesticides.7 In addition, the report states 

that childhood exposures to certain pesticides have been associated with 

neurodevelopmental effects such as attention-deficit/hyperactivity 

disorder and learning disabilities.

EPA has promoted children’s environmental health protection in an 

increasing number of ways over the past three decades. According to 

EPA officials, since the 1970s its national ambient air quality reviews 

have integrated protection of children and other at-risk populations. For 

example, in 1978 EPA set a National Ambient Air Quality Standard for

 

4

CDC, Advisory Committee on Childhood Lead Poisoning Prevention Report, January 4, 

2012.

5

Although no “safe” threshold of exposure has ever been identified, levels above 5 

micrograms per deciliter of blood (μg/dL) are considered elevated, according to the CDC. 

6 Y. Lambrinidou, S. Triantafyllidou, and M. Edwards, “Failing our Children: Lead in U.S. 

School Drinking Water,”New Solutions: A Journal of Environmental and Occupational 

Health Policy 20, no. 1 (2010): 25-47; D.E. Jacobs, R.P. Clickner, J.Y. Zhou, S.M. Viet, 

D.A. Marker, J.W. Rogers, D.C. Zeldin, P. Broene, and W. Friedman, “The Prevalence of

Lead-Based Paint Hazards in U.S. Housing,” Environmental Health Perspectives 110, no.

10 (2002): A599-606; N. Ribas-Fito, M. Sala, M. Kogevinas, and J. Sunyer, 

“Polychlorinated Biphenyls (PCBs) and Neurological Development in Children: a 

Systematic Review,”Journal of Epidemiology and Community Health 55, no. 8 (2001):

537-546.

7

EPA, America’s Children and the Environment, 3rd ed. (Washington, D.C.: January 2013). 
 

Page 3 GAO-13-254 EPA Children's Health

lead based on particular concerns about children’s sensitivity.8 In 1995, in 

response to new data regarding the potential adverse effects of 

environmental hazards on children, EPA established an agency-wide 

policy to ensure that the agency consistently and explicitly considers 

children in developing risk assessments, and environmental and public 

health standards. In 1997, EPA created the Office of Children’s Health 

Protection (OCHP) to support the agency’s efforts and formed the 

Children’s Health Protection Advisory Committee (CHPAC) to provide 

advice, information, and recommendations to assist the agency in 

developing regulations, guidance, and policies relevant to children’s 

health.

In roughly the same time frame as the creation of OCHP, two key 

legislative requirements were enacted and an executive order was signed 

to further protect children’s health. Both the Safe Drinking Water Act 

Amendments of 1996 (SDWA) and the Food Quality Protection Act of 

1996 (FQPA) were enacted with explicit provisions for considering 

children’s health in the decision-making process for certain regulatory 

actions. SDWA, as amended, requires that EPA, in selecting a maximum 

contaminant level (i.e., an enforceable limit for a contaminant in drinking 

water), must analyze the effects on vulnerable 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.9 Similarly, in selecting contaminants to consider for regulation, 

SDWA requires EPA to consider the effects on vulnerable subgroups, 

such as infants, children, and pregnant women that comprise a 

meaningful portion of the general population but are at higher risk.10

FQPA provides heightened protections for infants and children, directing 

EPA, in setting pesticide tolerances (i.e., the maximum legal amount of a 

pesticide residue that is allowed to remain on a food commodity that has 

been treated with the pesticide), to use an additional default 10-fold 

margin of safety to protect infants and children—unless data support a 

 

8

EPA has set National Ambient Air Quality Standards for six pollutants, termed “criteria” 

pollutants: carbon monoxide, lead, nitrogen oxide, ozone, particulate matter, and sulfur 

dioxides.

9

42 U.S.C. § 300g-1(b)(3)(C)(i)(V)(2013). 

1042 U.S.C. § 300g-1(b)(1)(C)(2013). 
 

Page 4 GAO-13-254 EPA Children's Health

different margin—taking into account the potential for pre- and postnatal 

toxicity and other factors.11

About a decade later, additional legislation was enacted relevant to EPA 

activities to protect children’s environmental health in schools. The 

Energy Independence and Security Act of 2007 requires that EPA—in 

consultation with the Department of Education, the Department of Health 

and Human Services (HHS)12 and other relevant agencies—develop 

voluntary guidelines to assist states in establishing and implementing 

environmental health programs in schools. The Energy Independence 

and Security Act also requires that EPA develop, in consultation with the 

Department of Education and HHS, voluntary guidelines for locating 

schools that are, among other things, to take into account the special 

vulnerability of children to environmental hazards.

We and EPA’s Office of Inspector General have raised concerns about 

the effectiveness of EPA’s actions to protect children’s health. In a 

January 2010 report, we found that EPA had not fully utilized OCHP and 

other child-focused resources and that it did not have a high-level 

strategy or dedicated resources for outreach and coordination.13 More 

generally, we found that EPA needed a high-level strategy for children’s 

health and greater leadership to make continued progress in protecting 

children from environmental threats. We recommended that the agency 

update and reissue a child-focused strategy, reevaluate the mission of 

OCHP and its Director, and take other steps to help ensure that EPA 

assumes high-level leadership and develops strategies and structures for 

coordinating efforts addressing children’s environmental health. EPA 

concurred with our recommendations and agreed to implement them. An 

 

1121 U.S.C. §346a(b)(2)(A)(standard for pesticides residues with a threshold effect), 

(b)(2)(C)(exposure of infants and children), (c)(2) (exemptions).

12In particular, within HHS, the Agency for Toxic Substances and Disease Registry is 

responsible for investigating community exposures related to certain hazardous chemical 

sites and releases; assessing associated health effects; recommending actions to stop, 

prevent, or minimize harmful effects; and conducting health studies.

13GAO, Environmental Health: High-level Strategy and Leadership Needed to Continue 

Progress toward Protecting Children from Environmental Threats, GAO-10-205

(Washington, D.C.: Jan. 28, 2010). In an earlier report, we recommended that EPA 

proactively use its children’s health advisory committee; see GAO, Environmental Health: 

EPA Efforts to Address Children’s Health Issues Need Greater Focus, Direction, and Toplevel Commitment, GAO-08-1155T (Washington, D.C.: Sept. 16, 2008).
 

Page 5 GAO-13-254 EPA Children's Health

EPA Inspector General (IG) report issued that same year made similar 

recommendations.14

In February 2010, EPA’s Administrator issued a memorandum reaffirming 

that the agency’s policy is to consider the health of pregnant women, 

infants, and children consistently and explicitly in all activities related to 

human-health protection, including performing risk assessments and 

setting standard practices. The Administrator also directed OCHP to take 

the lead in ensuring that EPA programs and regions are successful in 

their efforts to protect children’s health. OCHP’s current strategic plan 

reiterates that the office’s mission will be accomplished by providing 

leadership in identifying critical agency actions to protect children’s 

environmental health, among other efforts.

In light of these developments, you asked us to examine EPA’s progress 

in protecting children’s health. Specifically, this report determines (1) the 

extent to which EPA has implemented our 2010 recommendations 

concerning children’s health protection and (2) the role, if any, that OCHP 

has played in ensuring that key EPA program offices consider children’s 

health protection in their regulatory activities. The report also describes 

how OCHP has worked with external partners to leverage its resources to 

better protect children’s health.

To conduct this work, we reviewed relevant laws, regulations, and EPA 

guidance and interviewed senior officials at EPA headquarters. We also 

interviewed other stakeholders, including members of CHPAC and 

representatives of various children’s health advocacy groups, including 

the National Center for Healthy Housing; Healthy Schools Network, Inc.; 

and the National Environmental Education Foundation. More specifically, 

to determine the extent that EPA has addressed our 2010 

recommendations concerning children’s health, we interviewed key 

officials from OCHP and EPA’s Office of Policy, as well as members of 

CHPAC. Additionally, we attended two CHPAC meetings held in 

November 2011 and March 2012. We also reviewed EPA’s fiscal years 

2011-2015 strategic plan and other planning and guidance documents.

To better understand OCHP’s role and responsibilities in ensuring that 

key program offices consider children’s health protection in their 

 

14EPA Office of the Inspector General, Need Continues for a Strategic Plan to Protect 

Children’s Health, 10-P-0095 (Washington, D.C.: Apr. 5, 2010).
 

Page 6 GAO-13-254 EPA Children's Health

regulatory activities, we relied on OCHP’s analysis from fiscal year 2011 

based on the measures included in its fiscal years 2011-2013 strategic 

plan.15 We also interviewed workgroup participants on selected 

regulations analyzed by OCHP, including EPA program offices with lead 

responsibility for selected actions. Moreover, we interviewed key program 

officials at EPA that have statutory responsibility for addressing children’s 

health. Specifically, we interviewed officials from EPA’s Office of Water 

and Office of Pesticide Programs (OPP) to assess their efforts to protect 

children’s health under SDWA and FQPA, respectively. Additionally, to 

assess the reliability of summary data on OPP’s decisions to retain or 

alter the default 10-fold margin of safety from 1996 to 2012 that OPP 

provided to us, we interviewed OPP officials who maintain the data on 

pesticide tolerances, among other things, and determined that the data 

were sufficiently reliable for the purposes of this report. We also 

interviewed environmental health experts to get additional perspective on 

EPA’s children’s health efforts. To determine how OCHP has worked with 

external partners to leverage its resources to better protect children’s 

health, we reviewed and analyzed key EPA documents involving outreach 

and coordination. We focused on OCHP’s efforts to work with communitybased programs, train health care providers, and conduct research. We 

also reviewed budget documents and interviewed EPA officials and 

members of external organizations about OCHP’s outreach and 

coordination efforts. For more detail on our objectives, scope, and 

methodology, see appendix I.

We conducted this performance audit from November 2011 to August

2013 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.

EPA’s mission is to protect human health and the environment. The 

agency ensures that all Americans are protected from significant risks to 

human health and the environment where they live, work and play. As 

 

15This was the most recent period for which information was available when we began our 

work.

Background 
 

Page 7 GAO-13-254 EPA Children's Health

part of its mission, EPA states that protecting children’s health from 

environmental risks is fundamental to EPA’s mission and that the agency 

reduces negative environmental impacts on children through involvement 

in EPA rulemakings, policy, enforcement actions, research, and 

applications of science that focus on prenatal and childhood 

vulnerabilities. EPA views childhood as a sequence of life stages from 

conception through maternal/fetal development, infancy, and 

adolescence. These lifestages refer to a distinguishable time frame in an 

individual’s life characterized by unique and relatively stable behavioral or 

physiological characteristics that are associated with development and 

growth.16

In 1995, EPA established an agency-wide 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 address risks for children.

In 1997, EPA established OCHP, within the Office of the Administrator, to 

support and facilitate the agency’s efforts to implement its National 

Agenda. OCHP’s mission was originally 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. Since this time, the 

office’s mission has become more focused. According to OCHP’s 2010 

strategic plan, the office’s current mission is to “ensure EPA actions and 

programs further the protection of children’s environmental health,” and 

this mission is supported with the following four goals:

• Goal 1: Reduce negative environmental health impacts on children 

through rulemaking, policy, enforcement actions, research, and 

application of science that focuses on prenatal and childhood 

vulnerabilities.

 

16EPA, Guidance on Selecting Age Groups for Monitoring and Assessing Childhood 

Exposures to Environmental Contaminants, EPA/630/P-03003F (Washington, D.C.: 

November 2005). 

EPA’s Early Actions to 

Address Children’s 

Environmental Health
 

Page 8 GAO-13-254 EPA Children's Health

• Goal 2: Protect children through safe chemicals management.

• Goal 3: Coordinate national and international community-based 

programs to eliminate threats to children’s health.

• Goal 4: Measure and communicate progress on children’s 

environmental health.

Based on EPA’s fiscal year 2012 enacted budget, to accomplish its 

mission and goals, OCHP has staff resources of 18.2 full-time equivalents 

(FTE) in headquarters and the regions, including the Director, and a 

budget of approximately $7.48 million.17 To inform its various initiatives 

related to children’s health, EPA also established CHPAC in 1997. 

Through CHPAC, leading researchers, academics, health care providers, 

nongovernmental organizations, industry representatives, as well as state 

and local government representatives, advise EPA on regulations, 

research, and communication issues important to children’s health.

The President issued an executive order in April 1997 that established a 

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

environmental health risks and safety risks.18 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. 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 triggered if a 

rulemaking is likely to result in a rule that (1) may be economically 

significant, such as by having an annual impact on the economy of $100 

 

17An FTE generally consists of one or more employees who collectively complete 2,080 

work hours in a given year. Therefore, either one full-time employee or two half-time 

employees equal one FTE. 

18Executive Order 13045 § 2-202 (a) -(b), 62 Fed. Reg. 19,885 (Apr. 23, 1997).

Executive Order 13045—

Protection of Children 

from Environmental 

Health Risks and 

Safety Risks
 

Page 9 GAO-13-254 EPA Children's Health

million or more, and (2) concerns an environmental health risk or safety 

risk that an agency has reason to believe may disproportionately affect 

children.

In addition to the broad mandate to protect children’s health that was 

established by the President in Executive Order 13045, EPA is 

specifically directed by Congress to consider infants and children in two 

environmental statutes—SDWA, as amended, and FQPA.19

Overview of requirements: Under SDWA,20 as amended, EPA is 

authorized to regulate contaminants in public drinking water systems. The 

act requires that EPA identify and publish a list every 5 years of 

unregulated contaminants that may require regulation, called the 

contaminant candidate list. For at least five contaminants every 5 years, 

EPA is then to evaluate their occurrence, and the potential health risks 

associated with them, and decide whether a regulation is needed; these 

decisions on whether to regulate a contaminant are known as regulatory 

determinations. In listing contaminants and in considering them for 

regulatory determination, EPA is to select contaminants that present “the 

greatest public health concern,” taking into consideration effects on 

sensitive populations—such as children—that are identifiable as at 

greater risk of adverse health effects from exposure to contaminants in 

drinking water, among other factors. 21

Establishing drinking water standards: For contaminants that EPA has 

determined to regulate or been directed to regulate, EPA establishes 

legally enforceable standards for public water systems—called national 

primary drinking water regulations—which generally limit the levels of 

specific contaminants in drinking water that can adversely affect public 

health. In proposing such standards, SDWA requires EPA to prepare and 

use, among other things, an analysis of the effects of the contaminant at

 

19EPA considers children in undertaking actions under a broad range of statutes; in some 

instances, other statutes do not explicitly require consideration of impacts of the action on 

children, but their legislative histories may do so. For example, the Clean Air Act does not 

explicitly require special consideration of susceptible subgroups when setting the National 

Ambient Air Quality Standards, but its legislative history indicates the standard is to be set 

to protect the health of any sensitive group of the population.

20Pub. L. No. 93-523, 88 Stat. 1660 (1974) (codified as amended at 42 U.S.C. §§ 300f–

300j-26). Hereinafter, references to SDWA sections are as amended. 

2142 U.S.C. § 300g-1(b)(1)(C) (2013).

Statutory Requirements to 

Consider Children’s 

Environmental Health

The Safe Drinking Water Act
 

Page 10 GAO-13-254 EPA Children's Health

sensitive life stages—such as for infants, children, and pregnant 

women—that may have a greater risk of adverse health effects from 

exposure to the contaminants in drinking water than the general 

population.22 EPA’s Office of Water has primary responsibility for 

implementing these requirements of SDWA.

Overview of requirements: FQPA amended section 408 of the Federal 

Food, Drug and Cosmetic Act (FFDCA), by adding several new 

requirements including a new safety standard for establishing levels of 

pesticide residue on raw and processed food. Under FFDCA, a 

pesticide23 chemical residue is deemed unsafe in or on food unless EPA 

has established either a tolerance (i.e., the maximum legal amount of a 

pesticide residue that is allowed to remain on a food commodity that has 

been treated with the pesticide) or exemption from the requirement for a 

tolerance and the level of residues is within the tolerance or exemption.

24

Since FQPA was enacted in 1996, EPA may establish a tolerance only if 

the Administrator determines that the tolerance is safe (i.e., that there is a 

reasonable certainty that no harm will result from exposure to the 

pesticide residue from all food and nonfood sources).25 EPA may 

establish, amend, or revoke a tolerance for a pesticide; we refer to these 

collectively as tolerance decisions. These tolerance decisions may be 

made in conjunction with pesticide registrations, registration review, or 

 

2242 U.S.C. § 300g-1(b)(3)(C)(i)(V) (2013).

23A pesticide is a substance intended to repel, kill, or control any species designated a 

“pest” including weeds, insects, rodents, fungi, bacteria, or other organisms. The family of 

pesticides includes herbicides, insecticides, rodenticides, fungicides, and bactericides. A 

pesticide residue is a residue of pesticide left in or on food after application of the 

pesticide. 

2421 U.S.C. § 346a(a)(1) (2013). In this report, references to FFDCA are generally to 

section 408.

2521 U.S.C. § 346a(b)(2)(A) (2013). Specifically, a tolerance is “safe” if the Administrator 

has determined that there is a reasonable certainty that no harm will result from aggregate 

exposure to the pesticide chemical residue, including all anticipated dietary exposures and 

all other exposures for which there is reliable information. Similarly, EPA may establish an 

exemption from the requirement for a tolerance only if the Administrator determines that 

the exemption is safe; the term ‘safe’ means that the Administrator has determined that 

there is a reasonable certainty that no harm will result from aggregate exposure to the 

pesticide chemical residue, including all anticipated dietary exposures and all other 

exposures for which there is reliable information. Id. at (c)(2)(A).

The Food Quality Protection 

Act 
 

Page 11 GAO-13-254 EPA Children's Health

reregistrations.

26 These tolerance decisions may be initiated by 

submissions, called petitions, received from industry or the public; or 

independently by EPA. These actions are taken pursuant to section 408 

of FFDCA, which governs pesticide residues on food, among other things, 

and the Federal Insecticide, Fungicide, and Rodenticide Act that governs 

pesticide registration. For example, EPA may establish a tolerance as 

part of a new use registration, such as when a pesticide manufacturer 

seeks approval for use of an existing pesticide on a different food crop. 

Similarly, EPA may amend a tolerance when a pesticide manufacturer 

completes studies that were not available at the time the existing 

tolerance was set. According to EPA officials, generally, in both of these 

instances, the tolerance process would be initiated by a petition from the 

pesticide registrant. 

Establishing pesticide tolerances: In establishing or reviewing a tolerance, 

OPP is to combine information on pesticide toxicity (i.e., the degree to 

which a pesticide is harmful or deadly) with information regarding the 

route, magnitude, frequency, and duration of exposure to the pesticide 

through a risk assessment process. The risk assessment process 

involves the following four distinct steps:

• identification of the toxicological hazards posed by a pesticide;

• determination of the ‘‘level of concern” with respect to human 

exposure to the pesticide, including determination and application of 

safety factors;

• estimation of human exposure to the pesticide; and

• characterization of risk posed to humans by the pesticide based on 

comparison of human exposure to the level of concern.

 

26 Under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, EPA 

registers pesticides for distribution, sale, and use in the United States and prescribes 

labeling and other regulatory requirements to prevent unreasonable adverse effects on the 

environment. To obtain a registration, a company or person (registrant) must submit 

health and environmental effects data and other information for EPA’s review. If the 

registration is for a food use pesticide, the applicant must also submit a petition for all 

needed tolerances. EPA may register the pesticide and set a tolerance level for those 

pesticides used on food or animal feed, notify the registrant of deficiencies in the data or 

need for additional information, or reject the application. 
 

Page 12 GAO-13-254 EPA Children's Health

Thus, at the conclusion of the risk assessment process, OPP will 

establish a tolerance only if estimated exposure under the tolerance is 

below the level of concern. As amended by FQPA, FFDCA mandates 

that, in taking action on a tolerance, EPA assess risks to infants and 

children from the pesticide chemical residue, among other things. 

Specifically, FFDCA requires that, in taking actions on tolerances, 

including exemptions, EPA is to assess the risk of the pesticide chemical 

residue based on available information about consumption patterns 

among infants and children where disproportionate; the special 

susceptibility of infants and children to the residues; and the cumulative 

effects on infants and children of such residues and other substances that 

have a common mechanism of toxicity. Further EPA is to 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 regarding the safety of the pesticide 

chemical residue for infants and children.27

Applying an FQPA safety factor: FFDCA requires that when setting a 

tolerance that EPA apply “an additional default 10-fold margin of safety 

for the pesticide chemical residue and other sources of exposure . . . for 

infants and children to take into account potential pre- and post-natal 

toxicity and completeness of the data with respect to exposure and 

toxicity to infants and children.”

28 The statute provides the Administrator 

with the authority to apply a different margin of safety for a pesticide 

chemical residue if, on the basis of reliable data, such a margin would be 

safe for infants and children.29 In other words, EPA can only apply a 

safety factor other than the default 10-fold if data demonstrate that such a 

margin will be safe. Because this requirement of an additional safety 

factor was added to FFDCA by FQPA, it is commonly referred to as the 

FQPA safety factor. OPP interpreted these 1996 FPQA provisions in key 

 

27Pub. L. No. 104-170 § 405, 110 Stat. 1514 (Aug. 3, 1996) (amending FFDCA §408, 21 

U.S.C. § 346a) (codified at 21 U.S.C. § 346a(b)(2)(C)).

28Id. This provision is applicable to pesticides with threshold effects.

29Id.
 

Page 13 GAO-13-254 EPA Children's Health

2002 guidance.30 According to OPP’s 2002 guidance, the FQPA default 

10-fold children’s safety factor provision “both codifies and expands 

OPP’s past practice of applying uncertainty factors to account for 

deficiencies in the toxicological database.”

31 The guidance also explains 

how OPP will approach analyzing the body of data on a particular 

pesticide to determine whether to apply the default 10-fold safety factor to 

protect infants and children or to apply another safety factor. Per the 

guidance, OPP’s approach to this analysis is to consist of several key 

considerations as follows:

1. Completeness of the toxicity database—whether all the required 

toxicity studies on the pesticide have been submitted.

2. Completeness of the exposure database—whether the exposure data 

on the pesticide are complete.

3. Potential pre- and postnatal sensitivity—whether fetuses and infants 

may be particularly sensitive to health effects of the pesticide. For 

example, EPA may use results of reproductive or developmental 

studies to determine this sensitivity or other evidence regarding 

whether fetuses or children would tend to be more susceptible 

considering the nature of the pesticide’s health effects.

Presumption to apply safety factor: In its guidance, OPP states that the 

office is to interpret these statutory directives as essentially establishing a 

presumption in favor of applying an additional default 10-fold safety factor 

to pesticide risk assessments. However, the guidance also notes that it is 

just a presumption. According to the guidance, OPP is to consider the 

available data and determine whether there is reliable evidence 

demonstrating that a different safety factor is protective. Moreover, FQPA 

requires the agency to publish its determination that a pesticide chemical 

residue is safe for infants and children. According to OPP officials, OPP’s 

rationale for a tolerance decision is generally presented in EPA’s Federal 

Register notices for the proposed or final tolerance decision.

 

30EPA, Office of Pesticide Programs, “Determination of the Appropriate FQPA Safety 

Factor(s) in Tolerance Assessment” (2002). In 2003, OPP supplemented the 2002 

guidance in “Clarification on the Application of Database Uncertainty Factors as Described 

in the 2002 OPP FQPA 10X Guidance.” In 2008, OPP’s Health Effects Division, 

supplemented the 2002 guidance further with “Hot Sheet 30” (“Application of the FQPA 

safety factor in FFDCA risk assessments and additional uncertainty factors in FIFRA risk 

assessments”).

31Id.
 

Page 14 GAO-13-254 EPA Children's Health

Reassessing existing pesticide tolerances: When the law was enacted in 

1996, FQPA also required EPA to reassess, using the new safety 

standard, the more than 9,700 existing tolerances for pesticide residues 

on foods for the pesticides that were already registered. According to 

EPA officials, the agency completed the reassessments required by 

FQPA.32

Internal review of safety factors: OPP’s decisions regarding whether to 

reduce, retain, or increase the FQPA safety factor for a specific pesticide 

are reviewed internally by the office’s Toxicology Science Advisory 

Council, and its internal Risk Assessment Review Committee is 

responsible for validating these decisions.

EPA develops rules, regulations, and other agency actions through its 

Action Development Process (ADP).33 The ADP is a defined and wellestablished agency process for developing rules that provide for 

interagency involvement through participation in regulatory workgroups to 

ensure that scientific, economic, and policy issues are adequately 

addressed at appropriate stages. At specific points in rule development, 

the ADP provides opportunities for senior management to get involved 

early and to provide guidance and direction to staff. EPA finalized the 

current process in June 2004 and updated its guidance in March 2011.34

The overall process includes the following key activities:

• EPA assigns each action to one of three tiers based on the required 

level of cross-agency interaction, which is determined by reviewing 

the complexity, environmental and economic significance, and likely 

 

32Currently there are more than 1,055 active ingredients registered as pesticides, which 

are formulated into thousands of pesticide products that are available in the marketplace, 

according to an EPA website.

33Office of Policy officials told us that the ADP generally applies to actions that are signed 

by the Administrator and/or appear in the Regulatory Agenda. These officials also noted 

that pesticide tolerance decisions are not signed by the Administrator and for the past two 

decades have not appeared in EPA’s semiannual regulatory agenda, which states that it 

excludes routine actions such as pesticide tolerance decisions. EPA stated that for these 

reasons, pesticide tolerance decisions do not follow the ADP. 

34EPA’s Action Development Process: Guidance for EPA Staff on Developing Quality 

Actions, revised March 2011.

EPA Action Development 

Process
 

Page 15 GAO-13-254 EPA Children's Health

external interest in the action;35 for example, EPA assigns actions that 

are based on a human risk assessment—including assessments of 

environmental health risks to children—to tier 1 or tier 2. 

• The lead program office for an action follows a standard process to 

develop the proposed regulation and supporting analyses. For 

example, the lead program office convenes the workgroup that 

develops and drafts the action through such key tasks as (1) creating 

the analytical blueprint that spells out a workgroup’s plans for the data 

collection and analyses that will support development of a specific 

action, (2) completing data gathering, and (3) developing and 

presenting options that best achieve the goal of the action.

In October 2006, the Office of Policy issued additional guidance 

developed by OCHP to assist agency staff in integrating children’s health 

considerations into the rulemaking process.36 The children’s guidance 

describes provisions of Executive Order 13045 and EPA’s Policy on 

Evaluating Health Risks to Children. Figure 1 illustrates key steps in 

EPA’s ADP where children are to be considered by the agency.

 

35Tier 1 includes top actions that demand the ongoing involvement of the Administrator’s 

office and extensive cross-agency involvement. Tier 2 actions include significant science, 

policy, economic or other implementation issues where primary decision authority rests 

with lead program or regional offices. Tier 3 actions are those for which little cross-agency 

participation is needed and lead offices can design their own review processes.

36EPA’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, March 2006.
 

Page 16 GAO-13-254 EPA Children's Health

Figure 1: Steps Where Children Are Considered in the EPA Rulemaking Process

Note: In 1997, the President signed Executive Order (E.O.) 13045—Protection of Children from 

Environmental Health Risks and Safety Risks, which mandated a concerted federal effort to address 

children’s environmental health and safety risks. Early Guidance from EPA management is used to 

establish policy priorities and communicate expectations for the workgroup. A Preliminary Analytic 

Blueprint is a document that spells out a workgroup’s plans for the data collection and analyses that 

will support development of a specific action. The Detailed Analytic Blueprint is based on the 

Preliminary Analytic Blueprint. It is modified as necessary as a result of early guidance and should 

identify the key activities, analyses, consultation activities, contributors, and timelines.
 

Page 17 GAO-13-254 EPA Children's Health

a

The children’s health questions are addressed during the tiering process, step 2.

b

Both the Safe Drinking Water Act, as amended, and the Federal Food, Drug, and Cosmetic Act, as 

amended by the Food Quality Protection Act, include specific provisions requiring EPA to consider 

infants and children.

c

The 1995 Children’s Health Policy is considered during workgroup analysis and consultation, step 7.

d

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

e

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

Regional Administrator.

f

A docket can be established at any time during the rulemaking process, but it 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.

g

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 made substantial progress in addressing our 2010 

recommendations concerning the agency’s efforts to protect children’s 

health but has not fully implemented some of them. As figure 2 indicates, 

EPA has fully implemented five of the eight recommendations we made in 

January 2010 and has taken steps to address the remaining three 

recommendations.37

 

37GAO-10-205. 

EPA Has Made 

Substantial Progress 

in Addressing More 

than Half of Our 2010 

Recommendations 
 

Page 18 GAO-13-254 EPA Children's Health

Figure 2: Implementation Status of GAO’s 2010 Recommendations

EPA has fully implemented five of our eight 2010 recommendations by 

taking the following actions:

EPA Has Fully 

Implemented Five GAO 

Recommendations on 

Children’s Health 

Protection 
 

Page 19 GAO-13-254 EPA Children's Health

In our January 2010 report,38 we recommended that the EPA 

Administrator update and reissue a child-focused strategy that would 

articulate current national health priorities and emerging issues. To 

address our recommendation, the EPA Administrator issued a 

memorandum in February 2010 that reaffirmed the agency’s commitment 

to children’s health and also detailed a three-point EPA Children’s Health 

Agenda designed to, among other things, help ensure that EPA’s actions 

address the environmental origins of health problems in children. A copy 

of the 2010 memorandum is provided in appendix III. Specifically, the 

memorandum states that “it is EPA’s policy to consider the health of 

pregnant women, infants and children consistently and explicitly in all 

activities we undertake related to human-health protection, both 

domestically and internationally.” The following are descriptions of EPA’s 

February 2010 Children’s Health Agenda (in the memorandum), which 

outlines three priorities for the agency:

• Use the best science when developing regulations. EPA will use the 

best science in efforts to implement the nation’s environmental laws.

EPA will robustly and transparently address the potential for and 

uniqueness of health effects in children when developing regulations 

and agency policies with human health implications. EPA will work 

with states and tribes to ensure that regulations are effectively 

implemented and enforced and will work closely with external 

research partners to fill critical data gaps.

• Protect children through safe chemicals management. EPA will 

protect children through safe chemicals management. EPA will 

establish standards, policies, and guidance at home and abroad that 

help eliminate harmful prenatal and childhood exposures to pesticides 

and other toxic chemicals and work with Congress and stakeholders 

to identify effective approaches for the protection of children’s health 

in the context of the Toxic Substances Control Act (TSCA) reform.

39

• Coordinate national and international community-based programs to 

eliminate threats to children’s health. EPA will coordinate national and 

international community-based programs to eliminate threats to 

 

38GAO-10-205. 

39In 1976, Congress passed TSCA to provide EPA with the authority to obtain more 

information on chemicals and to regulate those chemicals that EPA determines pose 

unreasonable risks to human health or the environment. 

EPA Issued a Children’s Health 

Agenda Reflecting National 

Environmental Priorities and 

Emerging Issues 
 

Page 20 GAO-13-254 EPA Children's Health

children’s health and measure and communicate progress; EPA will 

expand implementation of successful community-based programs to 

protect and improve children’s health outcomes and will focus on 

underserved communities.

In our January 2010 report, we recommended that EPA ensure that its 

current strategic plan expressly articulates children-specific goals, 

objectives, and targets.40 EPA’s agency-wide strategic plan for fiscal 

years 2011-2015, issued on September 30, 2010, does identify children’s 

health as a top priority for the agency. EPA discusses children and other 

disproportionately exposed and affected groups, including low-income, 

minority, and indigenous populations, which require more explicit 

consideration in EPA’s chemical risk assessments and management 

actions under its goal of ensuring the safety of chemicals and preventing 

pollution. In addition, the agency more specifically discusses how it plans 

to address children’s health in its Cross-Cutting Strategy on 

Environmental Justice and Children’s Health, which describes the 

following objectives:41

• Implement the nation’s environmental laws in its regulatory capacity 

through use of the best science and environmental monitoring data to 

address environmental justice and children’s health considerations at 

each stage of the regulation development process. 

• Develop and use environmental and public health indicators to 

measure improvements in environmental conditions and health in 

disproportionately impacted communities and among vulnerable age 

groups.

• Take into account disproportionately impacted, overburdened 

populations and vulnerable age groups and encourage the use of 

“green chemistry” to spur the development of safer chemicals and 

production processes in its work on safe management of pesticides 

and industrial chemicals.

• Apply the best scientific methods to assess the potential for 

disproportionate exposures and health impacts resulting from 

 

40GAO-10-205. 

41In its strategic plan, EPA discusses a set of cross-cutting strategies it developed that are 

to achieve the mission outcomes articulated under its five strategic goals.

EPA Issued a Strategic Plan 

Incorporating Children’s Health 

Protection
 

Page 21 GAO-13-254 EPA Children's Health

environmental hazards on minority, and other vulnerable populations.

• Engage communities fully in its work to protect human health and the 

environment, working to address critical issues affecting children’s 

health and disproportionately impacted, overburdened populations.

• Work with other federal agencies to engage communities and 

coordinate funding and technical support for efforts to build healthy, 

sustainable, and green neighborhoods, and work with residents to 

promote equitable development.

According to the strategic plan, EPA will develop an annual action plan for 

each year of the strategic plan that lists specific actions and related 

targets the agency will take in carrying out the operating principles in the 

cross-cutting strategy. For example, in its 2011 annual action plan in 

helping to better manage pesticides and industrial chemicals, EPA 

committed to identifying 5 to 10 priority chemical hazards to children’s 

health by April 2011. The agency also committed in the action plan to 

consulting with the CHPAC to develop children’s health criteria for 

identifying chemicals for assessment and action under TSCA. According 

to EPA’s 2011 action plan status report, both actions have been 

completed.

In our January 2010 report, we recommended that EPA reevaluate the 

mission of OCHP and its Director to make the office “an agency-wide 

champion” for children’s environmental health. EPA reorganized the 

Administrator’s Office, including OCHP, in July 2010. To increase 

OCHP’s focus on children’s health, EPA moved the Office of Aging and 

the Environmental Education Division that had been located in the office. 

In addition, EPA created within OCHP the Regulatory Support and 

Science Policy Division to work with regulations and science, as well as 

the Program Implementation and Coordination Division to conduct 

coordination and outreach with program and regional offices.42 Prior to 

this reorganization, OCHP’s mission was broader including a focus on 

aging as well as environmental education.

43 The OCHP Director told us 

 

42Previously, OCHP was divided into four areas: (1) outreach and partnerships; 

(2) regulations, economics, data analysis; (3) science; and (4) aging initiative.

43OCHP’s prior mission was to “make the health protection of children and the aging a 

fundamental goal of public health and environmental protection in the United States and 

around the world.” 

EPA Has Reevaluated and 

Updated the Mission of the 

Office of Children’s Health 

Protection and Its Director
 

Page 22 GAO-13-254 EPA Children's Health

that, prior to the reorganization, OCHP focused more on science policy 

than on regulatory activities. The reorganization narrowed the mission 

and as noted in OCHP’s fiscal 2011-2013 strategic plan, the office’s 

mission is to ensure that EPA actions and programs further the protection 

of children’s environmental health.

The EPA Administrator assigned new responsibilities to OCHP in the 

February 2010 memorandum to EPA staff. According to the 

memorandum, OCHP is directed to take the lead in ensuring that program 

and regional offices are successful in their children’s health efforts; in 

addition, the memo indicates that the OCHP Director will be the main 

point-of-contact to assist program and regional offices in making 

children’s environmental health a priority in all agency programs and 

actions. OCHP staff reported that the Director now participates in seniorlevel meetings, including regulatory update meetings with the Deputy 

Administrator, quarterly meetings with regional managers, and attends 

senior policy meetings and program updates.

In our January 2010 report, we recommended that EPA use CHPAC 

proactively as a mechanism for providing advice on regulations, 

programs, plans, or other issues. EPA is using CHPAC as we 

recommended. For example, in March 2012, EPA sought advice from 

CHPAC in developing lead regulations and in coordinating agency 

programs to prevent childhood lead exposure. Additionally, at the request 

of the OCHP Director, CHPAC assisted in developing information about 

asthma disparities among racial and ethnic groups for EPA to use as part 

of its work on the President’s Task Force on Environmental Health Risks 

and Safety Risks to Children, which was established in 1997 and charged 

with recommending strategies for protecting children’s environmental 

health and safety. In May 2012, the task force published the Coordinated 

Federal Action Plan to Reduce Racial and Ethnic Asthma Disparities. 

Furthermore, EPA program offices have also worked more closely with 

CHPAC on a number of issues related to children’s heath since we issued 

our January 2010 report, according to CHPAC’s Co-Chair. For example, 

EPA’s Office of Air and Radiation provided a briefing to CHPAC on indoor 

air quality to help the committee identify priority areas. CHPAC’s 

EPA Is Proactively Using the 

Children’s Health Protection 

Advisory Committee
 

Page 23 GAO-13-254 EPA Children's Health

Designated Federal Officer (DFO)44 also works with other federal advisory 

committees, such as EPA’s Clean Air Scientific Advisory Committee and 

the Science Advisory Board on other issues to coordinate as needed. 

In our January 2010 report, we found that EPA’s involvement in two 

organizations authorized by Executive Order 13045 had not been 

consistent over the years. These organizations included the Federal 

Interagency Forum on Child and Family Statistics (Forum), a working 

group of 22 federal agencies that collect, analyze, and report data on 

conditions and trends in issues related to child and family well-being and 

the previously mentioned President’s Task Force. As a result, we 

recommended that EPA ensure participation, to the fullest extent 

possible, by OCHP or other key EPA officials in these interagency 

organizations.

OCHP officials told us they have been active participants in the Forum by 

helping to prepare statistical data and descriptive text on children’s wellbeing, such as lead levels in the blood of children that are included in the 

Forum’s biennial publications: America’s Children (2011) and America’s 

Children in Brief (2010). Additionally, an OCHP official is a member of the 

Forum’s reporting committee, which works on a number of issues 

involved in the creation of these reports, and has the responsibility to 

write and edit the Physical Environment and Safety section of America’s 

Children in Brief. OCHP also contributed to the 2012 edition of America’s 

Children in Brief: Key National Indicators of Well-Being and is working on 

the 2013 edition of America’s Children. 

OCHP officials also told us that they have had a major role in 

reinvigorating the President’s Task Force Steering Committee. The Task 

Force officially expired in 2005. Although the task force has not been 

officially reauthorized, EPA and other agencies that were members of the 

task force have been participating in various efforts to address children’s 

health concerns since January 2010.45 For example, OCHP’s Director has 

served as the Co-Chair of the Task Force that, among other things, 

 

44A DFO is a required position for all committees established under the Federal Advisory 

Committee Act (FACA). The DFO may chair each advisory committee meeting, approve 

agendas and maintain records, among other duties.

45According to EPA officials, the decision to reinvigorate the task force was announced in 

January 2010 in Washington, D.C., and was a result of talks between EPA, HHS, and the 

Executive Council on Environmental Quality. 

EPA Is Consistently 

Participating in Key 

Interagency Organizations 

Initiated Under Executive 

Order 13045 
 

Page 24 GAO-13-254 EPA Children's Health

addresses healthy homes, chemical exposures, and asthma disparities.

For example, the task force held a workshop on asthma disparities in 

December 2010 and, as we stated previously, in May 2012, published the 

Coordinated Federal Action Plan to Reduce Racial and Ethnic Asthma 

Disparities. OCHP officials said the office also played a major role in the 

task force’s 2012 efforts to coordinate federal action on lead exposure.

The agency has taken some steps to address the three remaining 

recommendations from our January 2010 report but has not fully 

implemented them.

In our January 2010 report, we found that EPA could not be assured that 

the agency had thoroughly addressed risks to infants and children 

because it neither systematically evaluated nor consistently documented 

how the agency considered children’s health risks in rulemaking. As a 

result, we recommended that the agency 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. Since the issuance of our January 2010 report, EPA has taken 

some actions to strengthen its data system called ADP Tracker by, 

among other things, developing more targeted screening questions for 

rule writers regarding the effects on children’s health of rulemakings and 

other actions. Specifically, EPA added two questions for rule writers to 

complete to help identify actions potentially involving children’s health 

when initiating a new workgroup addressing matters that may be 

appropriate for OCHP staff participation (see fig. 3 for the screening 

questions). According to Office of Policy officials, OCHP is one of a few 

EPA offices that has specific questions in ADP Tracker to assist its work. 

The officials said that these screening questions are an important tool to 

inform OCHP when a rulemaking is being initiated that may affect 

children’s health issues, so that OCHP may decide whether to become 

involved and assign resources.

EPA Has Taken Steps to 

Address Three 

Recommendations 

Supporting Children’s 

Health but Has Not Fully 

Implemented Them

Program Offices Do Not 

Consistently Identify Actions 

Involving Children’s Health in 

EPA’s Regulatory Tracking 

System 
 

Page 25 GAO-13-254 EPA Children's Health

Figure 3: Questions Used to Help Identity Actions Potentially Involving Children’s Health

However, OCHP cannot rely on these questions to consistently identify 

workgroups that are addressing matters that may be appropriate for 

OCHP staff participation because program offices’ rule writers have not 

consistently identified workgroup actions involving children’s health in 

ADP Tracker through the screening questions. A 2011 OCHP analysis 

has shown that, in some cases, the screening questions may not have 

been clearly understood by rule writers and left blank and, in other cases, 

rule writers may not have had the level of expertise necessary to 

complete the screening questions accurately. OCHP officials said that the 

2011 analysis showed that, in some cases, rule writers incorrectly 

indicated that a proposed action had no children’s health implications.

According to an OCHP official, one rule writer on a workgroup drafting a 

rule on national emission standards for hazardous air pollutants did not 

check “yes” in the ADP Tracker to indicate that the rule would impact 
 

Page 26 GAO-13-254 EPA Children's Health

children’s health until after discussing the issue with OCHP officials. The 

misunderstanding stemmed from the requirements in the Clean Air Act 

regarding technology-based standards. Even though the workgroup did 

perform analyses of the impacts of the rule to children, because the rule 

was primarily a technology-based mercury reduction standard other 

factors, including health implications for children, could not be considered 

when setting the standard. EPA offers training on how to consider 

children’s health issues in the ADP, but according to Office of Policy 

officials this training is not required for rule writers to understand how to 

respond to the screening questions related to children’s health. According 

to Office of Policy officials, rule writers represent a range of experiences 

with some having a broad understanding of children’s health issues, while 

others have very little; as a result, training is left to the discretion of each 

rule writer. OCHP officials acknowledged that rule writers may not have 

all the information necessary early on in the rulemaking process to 

determine whether an action has children’s health implications and, 

because they may have a limited understanding of how to address the 

screening question, they might not initially answer them. However, as one 

OCHP official noted, rule writers may revisit the screening questions at 

another point in the ADP, but they do not always do so for a variety of 

reasons, including limited data about the potential effect on children of 

what the rule is addressing as well as competing priorities.

OCHP officials told us that because of the issues with the screening 

questions in ADP Tracker identified in the 2011 analysis, they are using 

an alternative method—manually reviewing monthly tiering reports 

prepared by EPA’s Regulatory Steering Committee that list new 

regulations being developed by program offices, which would be 

unnecessary if answers to the screening questions were reliable.46 OCHP 

officials said the most effective way to ensure health risks to children are 

being assessed is to have OCHP staff participate in regulatory 

workgroups early in rulemaking activities. To become involved early in a 

rulemaking process, OCHP officials said they must be aware of a 

rulemaking at or near its initiation and have information on the extent to 

which the rulemaking could involve consideration of children’s health 

effects.

 

46Office of Policy officials noted that these monthly reports are reviewed throughout the 

agency by various offices to identify other offices’ relevant rulemakings. These reviews, 

according to Office of Policy officials, are generally the basis for potentially interested 

offices to make their initial decisions about whether and how to participate in an action.
 

Page 27 GAO-13-254 EPA Children's Health

In addition to difficulties in reliably identifying actions that involve 

children’s health, EPA does not have a specific process for the program 

office leading a regulatory workgroup to document compliance with the 

1995 children’s health policy, which calls for certain steps regarding 

children’s risks when a risk assessment is being conducted for a 

rulemaking. For example, in our May 2011 report on EPA’s 

implementation of SDWA requirements,47 we found that, for certain 

regulatory actions, EPA did not develop a child-specific risk assessment 

or document why one was not done. In that report, we found that the 

Office of Water had not developed separate children’s risk assessments 

when developing the 2008 regulatory determinations. Office of Water 

officials said that they believed their evaluation of the health risks of 

contaminants took into account sensitive subpopulations, including 

children, as required by the act. As we reported, EPA’s 2008 regulatory 

determination documentation did not explain how or whether the agency 

determined that a separate risk assessment for children was not 

warranted. EPA staff involved in the 2008 regulatory determination told us 

they were aware of EPA guidance for considering children’s health but 

were unaware of the 1995 policy.

When we asked for documentation on whether child-specific risk 

assessments were being conducted for current actions, as required by 

the 1995 policy, EPA was not able to provide this information. Officials 

from OCHP and the Office of Policy agreed that compliance with the 1995 

policy is not being documented in ADP Tracker. They suggested that this 

documentation could occur at different stages of the ADP. Officials from 

OCHP and the Office of Policy said that one possible way to document 

whether a risk assessment was or was not being conducted would be in 

the development of the analytical blueprint during the ADP, which 

establishes what analyses will be done to support the proposed rule. This 

would show that a risk assessment could be expected as part of the rule 

package or that none was necessary. Another option suggested by the 

Office of Policy official would be to document whether a child-specific risk 

assessment was completed near the end of the ADP at the Final Agency 

Review step, which occurs before the action package is sent to OMB or 

signed by the Administrator.

 

47GAO, Safe Drinking Water Act: EPA Should Improve Implementation of Requirements 

on Whether to Regulate Additional Contaminants, GAO-11-254 (Washington, D.C.: May 

27, 2011).
 

Page 28 GAO-13-254 EPA Children's Health

In our January 2010 report, we recommended that EPA reevaluate its 

1995 policy to ensure that it is consistent with new scientific research 

demonstrating the risks childhood exposures can have for developing 

disease later in life. As we stated earlier, the 1995 policy directs EPA staff 

to consistently and explicitly consider risks to infants and children as a 

part of risk assessments generated during its decision-making 

processes— or state clearly why it did not—in rulemakings and when 

setting standards to protect public health and the environment.

OCHP has updated various guidance documents since 1995 to 

emphasize the use of the best available science regarding children’s 

health risks. The OCHP Director told us that EPA had not updated the 

1995 policy because doing so would be resource intensive, taking away 

from the office’s involvement in regulatory and other actions, and 

becoming a strain on limited staff. OCHP officials stated that the intent of 

the 1995 policy is to include all of the latest advances in children’s health 

as the science continues to evolve and noted that, while the 1995 policy 

has not been updated, other relevant guidance documents have been 

brought up to date to ensure that current science is used to achieve the 

general policy.48 Officials also stated that the February 2010 memo from 

the Administrator discusses using the “best available research and data” 

and “best science” regarding children’s health risks. While OCHP officials 

said that the 1995 policy is still sufficient, senior staff from OCHP 

acknowledged that a reaffirmation of the 1995 policy would help clarify 

that the intent of the 1995 policy is to include the latest advances in 

science, elevate the importance of using applicable guidance, and would 

reiterate EPA’s commitment to protecting children’s health. We agree that 

such a reaffirmation would help clarify the intent of the policy but believe 

our prior recommendation still has merit.

 

48The following guidance documents address children’s health considerations and 

reference the links between early life exposures and disease later in life: 2005 

Supplemental Guidance for Assessing Susceptibility from Early-Life Exposures to 

Carcinogens; 2006 Guidance for Selecting Age Groups for Monitoring and Assessing 

Childhood Exposure to Environmental Contaminants; 2006 Framework for Assessing 

Heath Risks of Environmental Exposures to Children, and EPA’s Office of Research and 

Development’s 2008 Child-Specific Exposure Factors Handbook.

EPA Has Reevaluated Its 1995 

Children’s Health Policy and 

Believes It Is Adequate for 

Ensuring Consistency with 

New Scientific Research 
 

Page 29 GAO-13-254 EPA Children's Health

In our January 2010 report, we recommended that EPA establish key 

environmental health staff within each program and regional office, with 

linkages to OCHP, to improve cross-agency implementation of revised 

priorities and goals and ensure coordination and communication among 

EPA’s program offices. EPA has designated 10 regional school 

coordinators to improve coordination in the regions, but it has not 

established an OCHP liaison in each program office. The regional school 

coordinators work on all EPA programs within their respective regions 

that affect schools and school districts as well as with states and school 

professionals; they also address requirements for indoor air quality, 

chemicals used in the classroom, and encourage Energy Star energy 

efficiency activities, efforts to reduce accidental exposures to chemicals, 

improvements to outdoor air quality, recycling, community development, 

and proper siting of schools. The official said an OCHP liaison works with 

the regional school coordinators and holds monthly conference calls to 

coordinate these efforts. The OCHP liaison is also to coordinate with 

regions and program offices to ensure schools goals are met and 

measures are established. Similarly, the official said, a children’s 

environmental health protection coordinator within OCHP works with the 

10 regional children’s environmental health coordinators to ensure that 

regional activities are consistent with EPA strategic plans and goals in 

settings other than schools, such as child-care facilities. 

According to OCHP staff, the children’s environmental health coordinators 

also assist other constituencies like health care providers, parents, 

community leaders, and state and local officials addressing particular 

health issues relevant to children, such as asthma and lead exposure.

The OCHP Director also has quarterly conference calls with regional 

senior-level managers with children’s health responsibilities to facilitate 

information sharing between OCHP and the regions. According to OCHP 

staff, the OCHP Director also attends regulatory update meetings with 

EPA’s Deputy Administrator and holds periodic conference calls with 

senior-level program staff when the need arises. When we asked why 

EPA has not established an OCHP liaison in each program office, the 

OCHP Director stated that there is ample communication between OCHP 

and top program officials with respect to children’s health protection. In 

addition, the OCHP Director said that the periodic conference calls and 

other communication efforts are sufficient in making children’s health a 

focus in program offices and said that instituting a children’s health liaison 

in each program office is not necessary, but it may offer value. We agree 

that OCHP has increased communication at the regional level; however, 

we continue to believe that a liaison is needed in program offices because 

EPA Has Not Established Key 

Children’s Health Staff within 

Program and Regional Offices 

to Coordinate with OCHP 
 

Page 30 GAO-13-254 EPA Children's Health

while communication occurs where OCHP is involved in regulatory 

workgroups, information sharing is often lacking in other circumstances.

OCHP has increased its role to ensure that most EPA’s program offices 

consider children’s health protection in their regulatory activities. In the 

Administrator’s February 2010 memorandum, OCHP was directed to 

ensure that all program offices are successful in their efforts to protect 

children’s health. As such, OCHP has played a greater role in program 

offices’ development of selected regulations that potentially affect 

children’s health, since the office’s 2010 reorganization. OCHP has been 

involved in regulations that impact children’s health under several major 

environmental statutes, including the SDWA and FFDCA that include 

specific children’s health language. For example, OCHP has been more 

actively involved in determining drinking water program standards and 

other regulatory actions, including regulatory determinations, under 

SDWA. However, officials told us that the office has no regular 

involvement in and limited familiarity with OPP’s ongoing decision-making 

processes associated with the setting of individual tolerance levels in 

foods conducted under FFDCA. 

Consistent with the direction in the EPA Administrator’s February 2010 

memorandum, OCHP is to take the lead in ensuring that the programs 

and regions are successful in their efforts to protect children’s health.

Since the reorganization of the office in 2010, OCHP has been involved in 

more regulatory workgroups using the ADP, thereby playing a greater 

supporting role in program offices’ development of rules and regulations 

that could potentially affect children’s health. OCHP primarily supports 

EPA program offices during the ADP, such as the Office of Air and the 

Office of Water, by providing a children’s health perspective to regulatory 

workgroups that are responsible for developing EPA actions, rules, and 

regulations. The OCHP Director told us that OCHP was participating in 

more regulatory workgroups than at any time in the history of the office to 

reflect the priorities of the Administrator, which are consistent with the 

agency’s strategic plan. According to ADP guidance, there are several 

ways that OCHP can get involved in workgroups that are developing 

regulations that could potentially affect children’s health. For example, the 

program office with lead responsibility for developing an EPA action, rule, 

or regulation could ask OCHP to participate on a workgroup typically at 

OCHP Has Increased 

Its Role to Ensure

That Most EPA 

Program Offices 

Consider Children’s 

Health Protection in 

Their Regulatory 

Activities

OCHP Has Played a 

Greater Role in Program 

Offices’ Development of 

Selected Regulations That 

Potentially Affect 

Children’s Health
 

Page 31 GAO-13-254 EPA Children's Health

the initial stages of the ADP. OCHP could also request to participate on 

the workgroup, as an official member or as an unofficial advisor, if OCHP 

believes that children’s health issues are involved.49 According to OCHP 

officials, while participating on a workgroup, OCHP has the opportunity to 

provide input in the development of regulations. OCHP also can raise 

concerns with a proposed regulation at the final review stage, but officials 

from EPA’s Office of Policy and OCHP said that OCHP generally 

attempts to work out problems before they reach this point.

In fiscal year 2011, of the 106 new or ongoing regulations listed in EPA’s 

publicly available regulatory tracking system,50 31 were identified by 

program offices as having a potential impact on children’s health. Of 

those 31 regulations, OCHP officials told us they participated in 

workgroups involved in the development of 21 because they felt these 

were the highest priority actions for children’s health. To assist in 

determining whether workgroups adequately considered children’s health 

concerns, OCHP developed factors to measure whether ongoing 

workgroups were fully responsive to children’s health matters. The 

factors51 include information, such as whether the workgroup sufficiently 

addressed comments from OCHP staff; the workgroup reviewed childspecific literature, evaluated child-specific hazards and/or exposures, and 

selected appropriate child-specific risk management options; and whether 

OCHP staff participated in the workgroup. OCHP officials said that the 

determination as to whether a workgroup has been responsive to these 

factors is based on the professional judgment and experience of the 

OCHP staff member who serves on the workgroup. When an OCHP staff 

member did not serve on a workgroup, OCHP contacted the program 

office to ascertain how responsive the workgroup was to children’s health 

concerns based on the factors described above. According to OCHP’s 

 

49For actions that are conducted under the ADP, OCHP can use the ADP Tracker to 

identify rules flagged as potentially implicating children’s health, and then indicate it 

wishes to participate on the workgroup. However, as we are reporting, the data in ADP 

Tracker may not be complete. In addition, OCHP also has access to other databases that 

list rules EPA is working on, and has regular meetings with the Office of Policy to discuss 

rules and other topics of interest.

50This publicly available system called Reg DAART, includes a subset of information from 

ADP Tracker, which is EPA’s internal tracking system. 

51OCHP officials provided us with a list of six possible factors, which they refer to as 

criteria, including whether child-specific scientific literature was reviewed, but not all 

criteria are applicable to all actions. 
 

Page 32 GAO-13-254 EPA Children's Health

assessment, agency officials estimated that 20 of the 31 workgroups 

were fully responsive to children’s health concerns at the time of their 

assessment, and 11 were not.52 This OCHP assessment was a subjective 

review to address a goal in the OCHP strategic plan to provide the office 

with a perspective on the responsiveness of actions at a point during the 

ongoing ADP. While program offices did not have an opportunity to 

assess OCHP’s analysis, OCHP used the results to compare the success 

of the groups they participated in with those they did not. OCHP officials 

said that their analysis indicated workgroups were more likely to be 

responsive to children’s health concerns when an OCHP staff member 

serves on the workgroup. For a listing of these actions, see appendix IV.

Of the 31 regulatory workgroups involved with actions identified as having 

potential impact on children’s health, we reviewed the 6 that had finalized 

rules at the time of our analysis.53 We interviewed EPA program officials 

about OCHP’s role and effectiveness on the 6 workgroups we reviewed.

We also interviewed OCHP staff members who served on 4 of the 6 

workgroups. In some cases, OCHP staff members described OCHP’s 

contribution as limited because of the highly technical nature of the rule 

being considered or because OCHP joined the workgroup too late in the 

ADP.

In addition to workgroup participants, we also spoke with officials from 

several key program offices, including from the offices of Air, Water, 

Chemical Safety and Pollution Prevention, and Solid Waste and 

Emergency Response. These officials had positive comments about 

OCHP staff members’ contribution to their workgroups but said that they 

do not consistently utilize OCHP staff on their workgroups during the 

rulemaking process. For example, an official from one program office 

noted that OCHP does not have enough staff to participate in all of that 

office’s workgroups dealing with children’s health matters. According to 

OCHP officials, tracking the early steps of the rulemaking process 

manually through monthly tiering reports, as discussed earlier, is OCHP’s 

 

52OCHP served on 3 of the 11 workgroups. For the remaining 8, OCHP consulted with 

workgroup chairs in making their assessment for the workgroups responsiveness to 

children’s health. 

53Our analysis of the 6 workgroups that addressed final rules includes 2 of the 11 

workgroups that EPA found to be not fully responsive to children’s health issues. Of the 2 

that were not fully responsive, OCHP served on one of them, which involved the efficiency 

of heavy duty vehicles to reduce greenhouse gas emissions. 
 

Page 33 GAO-13-254 EPA Children's Health

current approach for identifying and prioritizing workgroups to join as 

early as possible, as they do not have adequate resources to join every 

workgroup that may involve children’s health matters.

54

According to OCHP officials, OCHP began playing a more active role in 

determining drinking water standards under SDWA and other regulatory 

actions in 2010, after the Administrator’s memo was released.55 OCHP 

staff members said that they have participated on workgroups associated 

with the forthcoming proposal for a drinking water standard for 

perchlorate—a naturally occurring and man-made chemical that may 

adversely affect the functioning of the thyroid gland, which produces 

hormones critical to the normal development and growth of fetuses, 

infants, and children. The perchlorate standard is scheduled to be 

proposed in December 2013, according to EPA officials.56 OCHP staff 

members also told us they have participated on the workgroups tasked 

with developing the contaminant candidate list under SDWA and 

determining whether selected chemicals on the list should be regulated.57

According to an OCHP official, OCHP staff members have also been 

involved with developing other rules promulgated by the Office of Water, 

including revisions to two national drinking water standards. This 

coordination between the Office of Water and OCHP represents an 

improvement to what we reported in our May 2011 report,58 where we 

found that relevant EPA staff, including staff from OCHP, had limited input 

in the preliminary regulatory determination for perchlorate. In our 2011 

report, we found that, by excluding relevant EPA offices, such as OCHP 

from a more participatory role, the agency did not avail itself of the 

expertise that resides in those offices. Instead, we determined that EPA 

 

54In addition to its manual review of monthly tiering reports, OCHP also reviews the results 

of screening questions in ADP Tracker to confirm that OCHP has identified relevant 

workgroups for its participation.

55An OCHP official noted that the office began participating on more workgroups for 

drinking water regulations and standards in March 2010. 

56EPA, Drinking Water: Regulatory Determination on Perchlorate, 76 Fed. Reg. 7762 

(Feb. 11, 2011) available at https://federalregister.gov/a/2011-2603. 

57As stated earlier, SDWA requires that EPA identify and publish a list every 5 years of 

unregulated contaminants that may require regulation, called the contaminant candidate 

list.

58GAO-11-254. 

OCHP Has Played a More 

Active Role in Determining 

Drinking Water Standards 

under SDWA since 2010
 

Page 34 GAO-13-254 EPA Children's Health

relied on the assessment of a small group of high-level management 

officials in making its 2008 preliminary determination not to regulate 

perchlorate. In February 2011, EPA reversed its 2008 preliminary 

decision and decided to regulate perchlorate.

ADP guidance indicates that representatives from any interested program 

office, such as OCHP, can participate on regulatory workgroups, such as 

those led by the Office of Water. Office of Water officials we interviewed 

said that OCHP staff often serve on regulatory workgroups when the 

topics are pertinent to children’s health. The OCHP officials we spoke 

with confirmed that OCHP staff members have participated on numerous 

regulatory workgroups initiated by the Office of Water including those 

developing National Primary Drinking Water Regulations.59 For example, 

OCHP staff members serve on the workgroup addressing revisions to the 

lead and copper rule and served on the workgroup addressing revisions 

to the Total Coliform Rule.60

 

59National Primary Drinking Water Regulations or primary standards are legally 

enforceable standards that apply to public water systems. Primary standards protect 

public health by limiting the levels of contaminants in drinking water or imposing treatment 

technique requirements.

60National Primary Drinking Water Regulations for Lead and Copper: Regulatory 

Revisions (and National Primary Drinking Water Regulations: Revision to the Total 

Coliform Rule). According to EPA’s December 2012 fact sheet, the Total Coliform Rule is 

intended to improve public health protection by reducing fecal pathogens to minimal levels 

through control of total coliform bacteria, including fecal coliform.
 

Page 35 GAO-13-254 EPA Children's Health

Because OPP does not follow the ADP for pesticide tolerance decisions, 

OCHP, as well as other program offices, are typically not involved in 

tolerance decisions61 for pesticide residues on processed and raw foods.

In addition, OCHP officials told us they do not track OPP’s decisions 

noting that OPP does not identify pesticide tolerance decisions with 

children’s health implications that would potentially enable OCHP to be 

involved.62 As such, OCHP is not informed about changes OPP makes to 

margins of safety for infants and children.63 OPP generally publishes 

explanations for its decisions to lower safety factors in the Federal 

Register, some of which have been described by some experts from 

academia and industry as complex or incomplete.

Although pesticide tolerance decisions can greatly affect children’s health, 

OCHP is not involved in such decisions. Office of Policy officials 

explained that these decisions have never been conducted under the 

ADP, which could involve OCHP and the other program offices. There are 

several reasons why this is the case. First, officials said that the ADP 

generally applies to actions that are prompted by EPA. According to 

officials, tolerance decision processes are not generally prompted by 

EPA; instead, they are in response to submissions, called petitions, 

received from industry or the public.64 Further, Office of Policy officials 

stated that these decisions are not signed by the Administrator and do not 

appear in the Regulatory Agenda—a long-standing method of handling 

tolerance decisions that has been agreed to by the Administrator of EPA 

and the Administrator of OMB’s Office of Information and Regulatory 

 

61As stated earlier, for purposes of this report, we refer to “tolerance decisions” as 

including not only the establishment or revision of a tolerance but also decisions to grant 

an exemption from the requirement for a tolerance. In addition, we refer to tolerance 

decisions in all contexts, which may include situations such as where a tolerance is 

established or reviewed as part of a pesticide registration or reregistration or a new use 

application, in response to a petition, or others.

62OPP posts its work plans on the EPA website. OCHP could review them to determine if 

it should get involved in pesticide registration and tolerance decisions. However, OCHP 

officials told us that the office has limited resources to devote to this activity and that the 

information included in these public documents does not always contain sufficient 

information to address children’s health priorities.

63According to EPA, In the late 1990s, OCHP had early involvement in establishing the 

framework for the risk assessment process that the OPP program continues to use for 

making tolerance decisions today.

64Office of Policy officials also noted that there are statutory time frames applicable to 

certain steps, such as determining tolerance petitions are complete. 

OCHP Has Had No Regular 

Involvement in Reviewing 

the Tolerance Decisions 

for Pesticide Residues 

on Foods

OCHP Is Not Involved in 

Pesticide Tolerance Decisions 
 

Page 36 GAO-13-254 EPA Children's Health

Affairs.65 OPP officials told us they publish more than 10000 Federal 

Register documents each year (e.g., notice of filings and final rules) that 

are related to tolerance decisions; this high frequency of actions is 

another reason OPP officials cited for why their office does not use the 

ADP process as it needs efficient procedures to handle tolerance 

decisions.66 The Pesticide Registration Improvements Extension Act 

imposes specific deadlines on EPA for pending applications for pesticide 

actions and, according to officials, the high frequency of actions would 

impede the agency’s ability to adhere to these time frames.

In a written response to GAO, OPP officials also said that EPA decision

making for tolerance decisions is relatively straightforward, generally 

receives few public comments, has resulted in “very few” lawsuits, and 

does not need an ADP workgroup to develop and evaluate regulatory 

options.67 OPP officials also referred to language commonly found in 

EPA’s Semi-Annual Regulatory Agendas that describes pesticide 

tolerances as routine actions.68 However, in a separate written response 

to GAO, OPP officials noted that such decisions can be particularly 

complex. Given the required evaluation of numerous toxicity databases 

and exposure analyses, among other assessments that go into tolerance 

decisions, it is unclear how such decisions could be routine in nature.

As we stated earlier, the Administrator directs OCHP to take the lead in 

ensuring that all EPA programs are successful in their efforts to protect 

children’s health. Since OPP does not participate in the ADP or any other 

collaborative process for pesticide tolerance decisions, and some of these 

 

65Under Executive Order 12866, the Office of Information and Regulatory Affairs reviews 

certain agency draft regulations—generally those that are economically or otherwise 

significant—before publication. According to the White House website, the office’s review 

serves to ensure adequate interagency review of draft rules, so that agencies coordinate 

their rules with other agencies to avoid inconsistent, incompatible, or duplicative policies.

66For comparison purposes, Office of Policy officials noted that there are approximately 

100 new actions tiered for the agency annually in the ADP.

67EPA stated that there have been only five legal challenges to EPA tolerance decisions 

while there have been more than ten thousand tolerance decisions made since passage 

of the FQPA.

68See, for example, EPA, Regulatory Agenda, 54 Fed. Reg. 45,272 (Oct. 30, 1989) (“the 

listings exclude ...routine actions (such as pesticide tolerances)”). Officials noted that this 

language has been used for more than 2 decades and still appears in every Semi-Annual 

Regulatory Agenda. 
 

Page 37 GAO-13-254 EPA Children's Health

decisions may have an impact on children’s health, OCHP and OPP are 

not operating consistently with the direction laid out in the memorandum.

OPP is primarily responsible for implementing the requirements of 

FFDCA with respect to tolerances and generally has not coordinated 

tolerance decisions with OCHP or with other EPA offices.69 OPP officials 

do not identify pesticide tolerance decisions with children’s health 

implications for OCHP involvement, nor do OCHP officials track OPP’s 

workplans for pesticide registrations or OPP’s decisions published in the 

Federal Register. 

From 1996 to 2012, OPP made pesticide tolerance decisions for 412 

pesticides and, in 308 or 75 percent of the cases, OPP applied a lower 

safety factor than the default 10-fold margin of safety for infants and 

children established by FQPA. OCHP was not involved in any of these 

decisions, even with the direction by the Administrator’s 2010 

memorandum indicating that it should take the lead in ensuring that EPA 

programs are successful in their efforts to protect children’s health. To 

make pesticide tolerance decisions, OPP conducts the needed analyses 

and assessments with its technical and policy/regulatory staff, in 

consultation with the Office of General Counsel, and it has developed a 

data set that tracks its decisions regarding the use of the FQPA safety 

factor over time.70 As shown in figure 4, OPP applied a 1-fold or 3-fold 

safety factor, in 308 instances, or 75 percent of the time.71 OPP retained 

 

69EPA officials noted that the agency’s Office of General Counsel reviews most tolerance 

decisions, among other decision documents.

70The information provided reflects the highest FQPA safety factor for a pesticide when 

there are different safety factors addressing various exposure scenarios for a given 

pesticide. In some instances, EPA may apply different FQPA safety factors to different 

exposure scenarios, depending on the reliability of available data for those scenarios.

71Data on safety factor decisions for this period were compiled and provided by OPP and 

report the most current and highest OPP-applied safety factor for each pesticide. The data 

do not count all the tolerances for each pesticide, because for each pesticide there may 

be multiple tolerances for multiple food products. The data also do not capture instances 

where a pesticide might have initially been assigned a 10-fold safety factor that was later 

reduced, such as after additional studies were completed. In less than 1 percent of the 

cases, EPA applied a safety factor that was an outlier and did not fit into the 1-fold, 3-fold, 

10-fold, or 30-fold safety factor category. In 3 percent of the cases, EPA applied a safety 

factor greater than the default 10-fold safety factor.

OCHP Is not Involved in 

Changes to Pesticide Tolerance 

Margins of Safety
 

Page 38 GAO-13-254 EPA Children's Health

the default 10-fold safety factor established by FQPA for less than onequarter of the pesticides for which it made tolerance decisions.72

Figure 4: EPA Summary of Pesticides with Safety Factor Decisions from 1996 to 

2012

Note: This figure represents 412 safety factor decisions made by EPA from 1996 through 2012. EPA 

determines the safety factor based on data completeness and children’s susceptibility and applies the 

selected safety factor to its calculations during risk assessments to determine the pesticide chemical 

residue allowed on raw and processed foods. A lower safety factor reflects less uncertainty about 

data completeness and fewer unaddressed concerns about children’s susceptibility whereas a higher 

safety factor denotes more uncertainty regarding these factors. FFDCA requires that, when setting a 

tolerance level for pesticides, EPA is to assess risks to infants and children and apply an additional 

10-fold margin of safety for the pesticide chemical residue and other sources of exposure to take into 

 

72Similarly, in September 2000, we reported that OPP applied the 10-fold safety factor in 

20 percent of the 105 safety factor decisions as of the end of March 2000 and a safety 

factor greater than 10-fold in 5 percent of the decisions. See GAO, Children and 

Pesticides: New Approach to Considering Risk is Partly in Place, GAO/HEHS-00-175

(Washington, D.C.: Sept. 11, 2000).
 

Page 39 GAO-13-254 EPA Children's Health

account potential pre-and postnatal toxicity and other factors. The act provides the Administrator of 

EPA with the authority to use a different margin of safety for a pesticide chemical residue if, on the 

basis of reliable data, such a margin would be safe for infants and children.

OPP officials told us that the agency bases the decisions to lower the 

FQPA safety factor on data they find reliable that demonstrate that a 

lower FQPA safety factor is protective of infants and children. OPP’s 

approach to analyzing the FQPA safety factor is to consider three areas 

of review: (1) completeness of the toxicity database—whether all the 

required toxicity studies on the pesticide have been submitted; (2) 

completeness of exposure database—whether the exposure data on the 

pesticide are complete; and (3) the potential pre- and postnatal 

sensitivity—whether fetuses and infants may be particularly sensitive to 

health effects of the pesticide. In explaining its approach, OPP officials 

stated that they would remove the default FQPA safety factor if the data 

are complete, and if the pesticide either shows no potential pre- or 

postnatal toxicity, or the dose level at which any pre- or postnatal toxicity 

is seen is well-defined. Conversely, OPP officials stated if concerns or 

uncertainties are raised concerning any of the three reasons (toxicity 

database, exposure database, pre- and postnatal toxicity), EPA would 

likely retain an additional safety factor.73 OPP stated that the rationale for 

each decision is presented in the Federal Register notices and supported 

by documents in the docket.74 In appendix V, we include information that 

OPP officials provided us on the rationale associated with tolerance 

decisions for 1 year—fiscal year 2011.

Even with the analyses conducted by OPP to support its FQPA safety 

factor decisions, OCHP recently participated in OPP’s review of the 

tolerance for chlorpyrifos to assure that children’s health is being 

adequately protected.75 For example, in 2011, external stakeholders 

noticed that OPP issued for public comment a draft evaluation of the 

human health risks associated with chlorpyrifos through a Federal 

Register notice. Chlorpyrifos is a pesticide that was discontinued from 

almost all home use in 2000 and discontinued or limited in certain foods, 

 

73The size of the additional factor would depend on the degree of uncertainty raised. 

74According to OPP officials, they have taken public comment on the vast majority of 

these decisions as part of the office’s public participation process for pesticide risk 

assessments.

75EPA stated that there have been few objections, and, as previously noted, only five legal 

challenges to EPA tolerance decisions since passage of the FQPA.
 

Page 40 GAO-13-254 EPA Children's Health

such as apples, grapes, and tomatoes because of its effect on children’s 

neurological systems. Until the stakeholder brought the matter to OCHP’s 

attention, OCHP did not know that OPP was considering reducing the 

default safety factor from 10-fold to 1-fold in its determination of the 

chlorpyrifos tolerance for some foods. OCHP voiced its desire to be 

involved in the decision-making process so as to ensure children’s health 

risks would be adequately accounted for and reached an agreement with 

OPP to provide a part-time staff person to work with OPP staff on the 

chlorpyrifos issue.76

OCHP officials noted that, without a process whereby OPP and OCHP 

can establish procedures for identifying tolerance decisions that could 

pose a significant risk to children’s health, it will be difficult for OCHP to 

engage in the future on those issues and take the lead in ensuring that 

programs are successful in their efforts to protect children’s health, as 

articulated in the 2010 Administrator’s memorandum. As we reported 

earlier, relying on relationships with individual officials alone as a means 

of establishing regular coordination among offices is often incomplete and 

inefficient.77 Moreover, these informal relationships could end once 

personnel move to their next assignments. Without updated, integrated, 

and comprehensive procedures in place for establishing and maintaining 

interactions among entities, the overall effectiveness of intra-agency

collaboration can be limited.

We contacted eight experts from academia and industry to discuss OPP’s 

FQPA safety factor decisions and whether there was a need for OCHP’s 

involvement in pesticide tolerance decisions. The experts included 

academics with expertise in pesticide health effects on children, and 

industry scientists who are regularly involved in pesticide registrations.

Most of the experts we interviewed noted that, based on their past 

experience in reviewing particular EPA tolerance decisions, some of the 

evidence that EPA used to support its decisions is considered confidential 

business information (CBI) and is therefore unavailable for public review. 

Industry experts confirmed that some data are considered CBI subject to 

EPA protective regulations and thus are excluded from the docket and 

 

76OCHP officials told us that the level of effort by OCHP for participating in matters related 

to chlorpyrifos is not sustainable for other pesticides, given OCHP’s limited resources.

77See GAO, National Security: Key Challenges and Solutions to Strengthen Interagency 

Collaboration, GAO-10-822T (Washington, D.C.: June 9, 2010). 

Industry and Academic 

Experts’ Queried on Pesticide 

Tolerance Decisions and the 

Need for OCHP Involvement 

in Them
 

Page 41 GAO-13-254 EPA Children's Health

public disclosure.78 However, OPP officials stated that CBI data are rarely 

relied on in making a safety determination and OPP reviews of the 

tolerance data are publicly available. These reviews contain descriptions 

of how the study was conducted and what effects were observed in the 

study as well as EPA’s conclusions regarding the studies. One academic 

expert noted that the absence of a group like OCHP in the pesticide 

decision-making process is problematic because there is no group 

outside of OPP, other than the Office of General Counsel, and no 

children’s health constituent group consulted in the process. As a result, 

OCHP cannot respond to outside groups’ concerns regarding pesticide 

decisions that may impact children’s health, although it is directed to be 

EPA’s lead office on children’s health matters.

Moreover, the five academic experts, but none of the industry experts, 

raised some concerns with the clarity of the published explanations for 

EPA’s decision to not use the default safety factor. However all of the 

industry experts, most of whom have day-to-day involvement in pesticide 

registrations, stated that the FQPA safety factor decisions were generally 

what they expected and that OPP’s explanations were adequate. The 

industry experts also agreed that the information supporting EPA’s 

decisions can be difficult to interpret and believed the agency could do a 

better job of explaining its process and presenting the tolerance 

information. All of the academic experts we spoke with, most of whom are 

not directly involved in the pesticide registration process, stated that the 

information provided to the public can be difficult to fully understand and 

were surprised by the frequent reductions in the safety factor.79

In addition, a 2011 court case addressed concerns that, in a particular 

instance, the basis for OPP’s decision regarding pesticide residues and 

what safety factor to protect children’s health was not adequately 

 

78OPP provides a summary of its supporting data in the relevant Federal Register notice 

and generally includes its analyses of health and safety studies and exposure data in the 

docket.

79We reported on challenges concerning the clarity and transparency of EPA’s 

development and presentation of information on health effects that may result from 

exposure to environmental contamination in GAO, Chemical Assessments: Challenges 

Remain with EPA’s Integrated Risk Information System Program, GAO-12-42

(Washington, D.C.: Dec. 9, 2011. 
 

Page 42 GAO-13-254 EPA Children's Health

explained.80 In Natural Resources Defense Council (NRDC) v. EPA, the 

U.S. Court of Appeals for the Second Circuit held that, for a subset of the 

risk assessments EPA did not provide an explanation of why a children’s 

safety factor of less than the default 10-fold was designed “to take into 

account potential pre- and postnatal toxicity and completeness of the data 

with respect to infants and children.”

81 The court also held that EPA did 

not identify reliable data and explain how those data showed that a safety 

factor of less than the default 10-fold would be safe for infants and 

children. In 2012, in response to the court’s remand, EPA issued another 

order, which again denied NRDC’s challenge to EPA’s tolerance decision 

using the lowered safety factor.82 While EPA reached the same decision 

as it had previously—that is, that the reduced (3-fold) safety factor would 

protect the safety of infants and children, the agency also stated it “now 

recognizes that the discussion of the FQPA safety factor in its dichlorvos 

[decision] and orders was less than transparent” and explained that it 

“used, at times, a form of short-hand that hid rather than elucidated its 

reasoning on the FQPA safety factor.”

83 Accordingly, the order stated that 

“EPA has provided a revised, more extensive explanation for its position” 

on the FQPA safety factor. NRDC challenged EPA’s revised order, and in 

 

80 NRDC v. EPA, 658 F.3d 200 (2d Cir. 2011). The court considered EPA’s explanations 

in the interim reregistration decision and two orders respectively denying NRDC’s petition 

and administrative objections. The court’s decision, however, directly concerns only one 

order, and did not vacate or remand the interim reregistration decision. The court denied a 

second claim and did not address a third claim by NRDC. The order represented a formal 

decision by EPA in response to objections filed by NRDC under the applicable statutory 

procedures. NRDC’s filing stated two objections to EPA’s denial of NRDC’s original 

petition that EPA revoke all dichlorvos tolerances.

81The dichlorvos registration and orders involved several distinct risk assessments. The 

subset of studies implicated here are those that relied on a human study referred to as the 

Gledhill study, rather than animal studies. 658 F.3d at 217. 

82EPA, Dichlorvos (DDVP); Order Denying NRDC’s Objections on Remand, 77 Fed. Reg. 

54,402 (Sept. 5, 2012).

8377 Fed. Reg. at 54,412. Dichlorvos is an insecticide used on crops, animals, and in peststrips. 
 

Page 43 GAO-13-254 EPA Children's Health

June 2013 NRDC and EPA entered a settlement and asked the court to 

stay the challenge.84 

While OPP publishes information supporting its pesticide tolerance 

decisions, many of which relate to children’s health, as noted above, the 

basis for some of these decisions may be difficult to understand, and 

some information deemed CBI may not be available for public review.85

Moreover, OCHP has no role in the tolerance decision process, and 

neither OPP nor OCHP have procedures to inform OCHP of pesticide 

tolerance decisions that have potential impacts on children’s health. With 

the vast majority of pesticide tolerance decisions being established with 

safety factors lower than the default safety factor established by FQPA, it 

is unclear how OCHP is to carry out the mission outlined in the 

Administrator’s 2010 memorandum directing it to ensure that program 

offices are successful in their efforts to protect children’s health.

 

84NRDC filed with the U.S. Court of Appeals for the Second Circuit a petition for review of 

EPA’s 2012 final order. NRDC asserted that in denying its petition for the revocation of the 

tolerance for dichlorvos, EPA improperly relied on a human health effects study that did 

not comply with ethical standards in effect at the time, and improperly denied NRDC’s 

hearing request. NRDC asked the court to vacate EPA’s 2012 order denying NRDC’s 

objections and evidentiary hearing request, and to prevent EPA from relying on the human 

study or, in the alternative, order EPA to grant NRDC’s hearing request. According to 

EPA, EPA and NRDC reached a settlement under which EPA agreed to reassess the safe 

level of exposure to dichlorvos and draft a memorandum explaining its reassessment by 

May 31, 2014, among other things. According to court documents, if EPA does not 

perform its obligations under the final settlement agreement by May 31, 2014, NRDC may 

reinstate the petition for review; conversely, the petition for review shall be subject to 

dismissal after EPA completes performance of its obligations under the final settlement 

agreement or if the petition for review is not timely reinstated.

85Although not publicly available, according to EPA officials, the actual studies with the 

raw data can be inspected or viewed as long as the person affirms that he or she will not 

deliver the data to a foreign or multinational pesticide business.
 

Page 44 GAO-13-254 EPA Children's Health

OCHP has worked extensively with a variety of partners to leverage its 

resources to better protect children’s health. OCHP has, for example, 

coordinated with federal partners to improve children’s environmental 

health in homes and schools. OCHP also has worked with local, tribal, 

and public service partners to improve children’s environmental health in 

underserved communities. In addition, OCHP has worked with medical 

experts to enhance health care providers’ knowledge about 

environmental risks to children.

OCHP continues to work with a number of federal partners, as well as 

coordinate internally and with nongovernment partners, to protect children 

in homes and schools. Specifically, OCHP has helped to develop an 

integrated strategy, released in February 2013, to encourage healthy 

home environments for children as a member of the federal Healthy 

Homes Work Group, which includes members from the Departments of 

Housing and Urban Development, Health and Human Services, 

Agriculture, Energy, Labor and the National Institute of Standards and 

Technology.86 The strategy, Advancing Healthy Housing: A Strategy for 

Action, includes long-term goals and an integrated website with 

information on topics, such as poisons and dangerous chemicals, pest 

control, and child safety. The strategy capitalizes on the collective 

expertise of the workgroup member agencies by establishing a new vision 

for addressing health and economic burdens caused by preventable 

environmental health and safety hazards in the home. The strategy 

contains five broad goals and priorities in healthy housing for the next 3 to 

5 years. Specifically, the strategy calls for (1) establishing federally 

recognized recommendations for healthy homes, (2) encouraging the 

adoption of healthy homes recommendations, (3) creating and supporting 

training and workforce development to address health hazards in 

housing, (4) educating the public about healthy homes, and (5) supporting 

research that informs and advances healthy housing in a cost-effective 

manner. According to the strategy, to achieve these goals, federal 

partners in the workgroup are urged to coordinate their efforts in a 

number of activities. For example, to encourage the adoption of healthy 

 

86The strategy is intended to unify federal action for advancing healthy housing through a 

comprehensive approach, known as the “healthy homes model.” The Healthy Homes 

Work Group expects the model can be used nationwide to reduce health care costs by 

promoting better healthy housing conditions.

OCHP Has Worked 

with External 

Partners to Leverage 

Its Resources to 

Better Protect 

Children’s Health

OCHP Has Coordinated 

with Federal Partners to 

Improve Children’s 

Environmental Health in 

Schools and Homes
 

Page 45 GAO-13-254 EPA Children's Health

homes criteria, the workgroup will obtain commitments from member 

agencies to advance healthy housing, strengthen federal efforts to reduce 

public health risks in housing, and explore ways to increase funding 

flexibility across federal and nonfederal programs.

According to EPA officials, the healthy homes website, is expected to be 

launched in the spring of 2013 by the Department of Housing and Urban 

Development. The website is intended to be a “one-stop shop,” where the 

public will be able to obtain assistance in creating healthy home 

environments. The officials said that the website is to consist of a number 

of interactive functions geared toward providing information to specific 

users. For example, health topics, such as hazardous household 

chemicals, integrated pest management, how to identify and mitigate 

radon, and other items will be tailored for both homeowners and renters.

Moreover, according to a draft presentation on the healthy homes 

website, owners and renters will have the ability to print out personalized 

home safety checklists by answering a series of questions regarding their 

homes. Users will also have the ability to identify local resources through 

a map interface and share information by using social networks links on 

the website. Users will also have the ability to watch videos and obtain 

tips on ways to create healthy environments in their homes.

The workgroup’s strategy also includes training initiatives, some of which 

are managed through the National Center for Healthy Housing.87

According to an OCHP official, the training effort includes approximately 

25 courses each year that will reach about 800 participants with EPA 

funding. The training includes a 2-day course, “Essentials for Healthy 

Homes Practitioners,” and a number of 1-day courses dealing with topics 

such as pest management, energy efficiency, and other healthy homes 

topics. The training sessions are offered around the country and will 

target communities where the need is greatest.

In another initiative, OCHP has worked with federal partners to make 

schools environmentally safer, particularly with respect to selecting 

 

87The National Center for Healthy Housing is a nonprofit organization with a staff of 16, 

including housing, health and environmental professionals with expertise in biostatistics, 

epidemiology, environmental health, public health, housing policy and industrial hygiene. 

The center operates the National Healthy Homes Training Center through a cooperative 

agreement with the CDC and support from the U.S. Department of Housing and Urban 

Development and EPA. The Training Center is aimed at helping states, cities, and 

community-based organizations effectively identify and address housing-related hazards.
 

Page 46 GAO-13-254 EPA Children's Health

appropriate school locations and designing state programs to improve 

environmental health in schools. OCHP has consulted with the 

Departments of Education and Health and Human Services as well as 

CHPAC in developing school siting guidelines. OCHP has also 

collaborated with a number of EPA offices on the school siting guidelines, 

including EPA’s Office of Air and Radiation, Office of Sustainable 

Communities, and Office of Solid Waste and Emergency Response. 

These guidelines, which are required under the Energy Independence 

and Security Act, are voluntary and are designed to help localities, tribes, 

and the public better understand and appropriately consider 

environmental and public health factors prior to selecting school locations.

They are not intended to replace state, tribal, or local school site or 

location selection policies or requirements but rather to assist local school 

districts and community members in evaluating environmental factors in 

making school siting decisions. The guidelines take into account: (1) the 

special vulnerabilities of children to hazardous substances, (2) the 

possibility of contamination at a potential school site, (3) the modes of 

transportation available to students and staff, (4) the efficient use of 

energy at the location, and (5) the potential use of the location as an 

emergency shelter. The guidelines are applicable to a wide range of 

school-related facilities, including K-12 public and private schools, 

technical and vocational schools, and colleges and universities. They also 

address the need for meaningful public involvement, establishment of 

environmental criteria and review processes, and evaluation of nearby 

sources of air pollution. The guidelines also contain a quick reference 

guide with information on some major environmental issues like air 

pollution, radon gas, pesticides, and mold.

To improve environmental health in schools, OCHP has coordinated with 

the Department of Education, the Centers for Disease Control and 

Prevention, the Agency for Toxic Substances and Disease Registry, the 

Department of Agriculture, the Department of Defense, the Bureau of 

Indian Education, the White House Council on Environmental Quality, and 

a number of EPA offices to develop guidelines for states to protect the 

health of students and school staff by addressing environmental health 

issues commonly encountered on or around schools. As is the case with 

the school siting guidelines, the Voluntary Guidelines for States: 

Development and Implementation of a School Environmental Health 

Program are required under the Energy Independence and Security Act.

The guidelines are not intended to replace existing school environmental 

health regulations, but they can be used as a resource in establishing 

school environmental health programs. The guidelines are applicable to a 

wide range of school-related facilities, including K-12 public and 
 

Page 47 GAO-13-254 EPA Children's Health

charter/private schools, technical and vocational schools. The guidelines 

contain best practices that states can use to help develop key 

partnerships that maximize existing resources. These best practices 

include assessing existing resources and infrastructure, determining 

capabilities, developing a plan, implementing the program, evaluating the 

program, and sustaining the program.

For example, in the early stages of developing an environmental health 

program, the guidance calls for states to identify a lead office to assess 

existing state laws, policies, or regulations that address healthy school 

environments. In the later stages, the guidance calls for states to 

determine whether program goals need to be revised or expanded and to 

conduct regular program evaluations. The guidelines address the cost 

savings and health benefits associated with adopting a school 

environmental health program and encourage states to work with school 

districts to implement healthy schools practices. Moreover, the guidelines 

include links to a variety of resources for states to address school 

environmental health issues, such as contaminants in drinking water, pest 

management, and noise reduction, as well as a model K-12 school 

environmental health program to help schools and school districts in 

planning their own environmental health programs.88

OCHP has worked with tribal, local, and public service partners to 

address children’s environmental health issues particularly in 

underserved communities. For example, OCHP has, in coordination with 

EPA program offices, worked with the Navajo Nation to improve water 

quality in tribal communities, and with the American Lung Association to 

reduce children’s exposure to air pollutants among the Oglala Sioux Tribe 

in South Dakota. OCHP has also worked with numerous community 

organizations including the Boys and Girls Clubs of America to 

incorporate children’s health protection into community-based, afterschool programs. Additionally, OCHP has awarded grants to 

organizations, such as the National 4-H Society, the National Family 

Career and Community Association, the United National Indian Tribal 

Youth Organization, and the Girl Scouts of the United States of America.

 

88OCHP indicated that they awarded five grants to states totaling $750,000 in the fall of 

2012 for implementing state school health programs.

OCHP Has Worked with 

Local, Tribal, and Public 

Service Partners to 

Improve Children’s 

Environmental Health in 

Underserved Communities
 

Page 48 GAO-13-254 EPA Children's Health

Additionally, OCHP has financially supported a number of children’s 

health efforts in underserved communities across the country. According 

to EPA officials, OCHP awarded approximately $1.2 million in fiscal year 

2011 to various entities to help them build their capacity to address 

children’s environmental health issues in their communities. For example, 

the Baltimore City Health Department received a $100,000 grant for its 

Healthy Environments for City Kids Program, which focuses on increasing 

the long-term ability of Baltimore’s at-risk, low-income communities to 

recognize and reduce children’s exposures to environmental dangers, 

such as lead, mold, pest, carbon monoxide, and tobacco smoke.

Likewise, the National Nursing Centers Consortium, in Washington, D.C., 

received a $100,000 grant for its prenatal and Early Childhood Provider 

Training Initiative. The consortium is a national organization with a 

mission to advance nurse-led health care through policy, consultation, 

programs, and applied research. The consortium used the grant to build 

the capacity of Washington, D.C.’s social service providers to help them 

ensure that low-income pregnant women and low-income families are 

educated about the impacts of home-based environmental health hazards 

and asthma triggers for children. Farm Worker Justice, a nonprofit 

organization that seeks to empower migrant and seasonal farm workers 

by, among other things, improving their living and working conditions, also 

received a grant award of $100,000 for its Healthy Kids, Healthy Fields 

project. The project involves three community-based farm worker 

organizations located in California, Arizona, and Florida. The grant was 

used to provide outreach and educational activities for families of farm 

workers to improve the environmental health of their children and to build 

the capacity of the partner organization to support future outreach to 

connect more farmers with local resources.

OCHP, in conjunction with CDC’s Agency for Toxic Substances and 

Disease Registry, has worked with Pediatric Environmental Health 

Specialty Units (PEHSU) to improve health care providers’ knowledge of 

prenatal and childhood environmental exposures. According to the 

PEHSU website, a PEHSU is special unit, normally based in university 

medical centers, aimed at improving the environmental health of children 

through use of a network of experts in environmental health. PEHSUs are 

located across the United States, Canada, and Mexico and are able to 

respond to requests for information and offer advice on prevention, 

diagnosis, management, and treatment of environmentally related health 

effects in children. PEHSUs include medical experts in fields, such as 

allergy/immunology, neurodevelopment, toxicology, and environmental 

medicine. They primarily provide the following services: 

OCHP Has Worked with 

Medical Experts to 

Enhance Health Care 

Providers’ Knowledge 

about Environmental Risks 

to Children
 

Page 49 GAO-13-254 EPA Children's Health

(1) education/community outreach on pediatric environmental health to 

clinicians/health professionals, clinical trainees and the general public; (2) 

consultation for clinicians/health professionals regarding children’s 

environmental health concerns; and (3) referrals to appropriate resources 

for children with environmental health needs (see fig. 5). For example, 

according an OCHP official, PEHSUs used information from OCHP to 

help train 15,000 health care providers across the country about prenatal 

and childhood environmental exposures and their health implications.

PEHSUs also work with federal, state, and local agencies to address 

children’s environmental health issues in homes, schools, and 

communities.

Figure 5: Services Provided by Pediatric Environmental Health Specialty Units
 

Page 50 GAO-13-254 EPA Children's Health

Protecting the health of children from environmental hazards is an integral 

part of EPA’s mission to protect human health and the environment. EPA 

created OCHP to support its efforts to ensure that the agency consistently 

and explicitly considers children in its health protection efforts. Over the 

past 5 years, we have reported on numerous weaknesses in EPA’s 

efforts to protect children’s health and the many challenges the agency 

faces in integrating children’s health protection in EPA’s decision-making 

processes. Since our January 2010 report, EPA has made substantial 

progress in addressing most of our recommendations but has not fully 

implemented some of them. For example, EPA developed an agencywide strategic plan that emphasizes children’s health and contains a 

cross-cutting strategy with children-specific goals, objectives, and targets 

in response to our recommendations.

EPA continues, however, to struggle with several fundamental problems 

that we have identified in the past that may undermine the agency’s ability 

to ensure that children’s health protection is considered in all agency 

processes. Specifically, EPA has not taken the steps necessary to 

improve OCHP’s ability to use the rulemaking system efficiently to identify 

actions potentially involving children’s health, such as which regulatory 

workgroups would be appropriate for OCHP staff participation. EPA 

developed several children’s health-related screening questions and 

included them in the ADP Tracker database, but EPA’s own analysis 

shows that EPA rule writers are not always answering the questions 

consistently or accurately. EPA offers training on how to consider 

children’s health in the ADP. However, according to Office of Policy 

officials, this training is not required for rule writers to understand how to 

respond to the screening questions related to children’s health. Because 

of the problems associated with the screening questions in ADP Tracker, 

OCHP staff is manually reviewing reports to identify regulations 

potentially affecting children’s health. Until rule writers are able to 

consistently and accurately answer the screening questions in ADP 

Tracker to identify regulatory actions potentially affecting children’s 

health, OCHP will not be able to effectively use its resources to provide 

input to EPA workgroups addressing matters that may be appropriate for 

OCHP staff participation.

Moreover, EPA does not have a specific process for program offices that 

lead regulatory workgroups to document how the agency considers 

children’s health risks in rulemakings and other actions or how their 

analyses comply with the 1995 Policy on Evaluating Health Risks to 

Children. EPA officials stated that such documentation could occur either 

at the preliminary analytical blueprint stage or the final agency review 

Conclusions 
 

Page 51 GAO-13-254 EPA Children's Health

stage of the ADP. Without such documentation, EPA will continue to be 

hampered in both tracking how its regulatory actions address potential 

children’s health issues and ensuring that the child-specific risk 

assessments required by the 1995 policy are being conducted.

In our January 2010 report, we recommended that EPA reevaluate its 

1995 policy to ensure its consistency with the latest scientific research 

demonstrating the risks childhood exposures can pose for disease in later 

life stages. OCHP officials told us that they had reevaluated the policy 

and determined that it was sufficient and said that the intent of the 1995 

policy was to include the best available science in the development of 

agency actions. EPA officials also stated that other relevant guidance 

documents have been updated since 1995 to ensure that current science 

is used to achieve the general policy and that an updated policy is not 

needed. However, we found that certain regulatory actions did not 

develop child-specific risk assessments or document why they were not 

done, as directed by the 1995 policy, and recommended in our May 2011 

report on EPA’s implementation of SDWA requirements. Rather than 

updating the policy, OCHP officials acknowledged that a reaffirmation of 

this policy could clarify that the intent of the 1995 policy was to utilize the 

best available science, elevate the importance of using the latest 

applicable guidance, and reiterate EPA’s commitment to protecting 

children’s health in the rulemaking process.

Notwithstanding the Administrator’s February 2010 memorandum, which 

directs OCHP take the lead in ensuring that EPA program and regional 

offices are successful in their children’s health efforts, OCHP plays no 

role in OPP decisions related to pesticide tolerances that can have an 

impact on children’s health. Instead, with respect to these decisions, OPP 

operates independently of EPA’s standard regulatory process—the 

ADP— and, therefore, OCHP and other program offices are not involved.

OCHP officials acknowledged that, in addition to not being directly 

involved in pesticide decisions, they do not track, and OPP does not 

identify for OCHP, pesticide tolerance decisions with children’s health 

implications. Furthermore, since OCHP has no involvement in pesticide 

decisions, it is not informed about changes OPP makes to margins of 

safety for pesticide chemical residue. Our review found that, in a large 

majority of cases, OPP does not use the default 10-fold safety factor for 

protecting children but, as allowed under FQPA, reduces the additional 

safety factor margins specifically established for infants and children 

under FQPA. While these decisions are explained by OPP in Federal 

Register notices, and assessing these decisions was outside the scope of 

our review, experts we spoke with have raised questions concerning the 
 

Page 52 GAO-13-254 EPA Children's Health

clarity of the justification provided by OPP for these decisions, while a 

court found EPA did not provide the requisite explanation in one instance. 

Experts noted as well that because the justification for these decisions 

may rely on CBI, a full public explanation for OPP’s decision may not be 

possible, and one expert noted that these issues highlight the importance 

of having an EPA office independent of OPP—like OCHP—involved in 

this process. With no formal role in the pesticide tolerance decision 

process and no procedures to alert OCHP when matters that could pose 

a significant risk to children’s health are being considered, it is not clear 

how OCHP can fully carry out its responsibilities as directed in the 

Administrator’s February 2010 memorandum. OCHP officials 

acknowledged that due to limited familiarity with OPP’s internal tolerance 

setting process and to limited staff resources they are unable to be 

involved in OPP actions on a regular basis, and OPP officials expressed 

concern regarding the practicality of involving OCHP in its pesticide 

tolerance decision process. Nonetheless, until the conflict between the 

expectations identified for OCHP in the Administrator’s memorandum and 

the current process is addressed, OCHP’s responsibilities regarding 

protecting children’s health in the area of pesticide tolerance decisions 

will remain unclear.

We are recommending that the EPA Administrator take the following four 

actions:

• Make children’s health training that includes how to respond to the 

screening questions a priority for rule writers.

• Require lead program offices to document their decisions in 

rulemakings and other actions regarding how health risks to children 

were considered (e.g., conducting a children’s risk assessment) and 

that their decisions are consistent with EPA’s children’s health policy.

• Reaffirm the 1995 Policy on Evaluating Health Risks to Children to 

clarify the intent of the policy to reflect the best available science, 

emphasize the importance of using applicable guidance, and reiterate 

EPA’s commitment to protecting children’s health.

• Direct OCHP and OPP to establish procedures to identify tolerance 

decisions that could pose a significant risk to children’s health and 

provide opportunities for OCHP involvement consistent with the 

Administrator’s 2010 memorandum.

Recommendations for 

Executive Action
 

Page 53 GAO-13-254 EPA Children's Health

We provided a draft of this report to EPA for its review and comment. In 

written comments, OCHP’s Acting Director, responding on behalf of EPA, 

wrote that EPA generally agreed with our findings, conclusions, and 

recommendations. EPA’s written comments on our draft report are 

included in appendix VI. However, EPA’s comments state that the agency 

believes that some aspects of the report mischaracterize and 

underemphasize important strides that have been taken to protect 

children, and as a result, provided technical comments, which we 

incorporated into the report as appropriate.

In response to our recommendation that the EPA Administrator make 

children’s health training that includes how to respond to the screening 

questions a priority for rule writers, in its comments, EPA stated that the 

agency is committed to exploring ways to educate rule writers. In 

response to our recommendation that the EPA Administrator require lead 

program offices to document their decisions in rulemakings and other 

actions regarding how health risks to children were considered (e.g., 

conducting a children’s risk assessment) and that their decisions are 

consistent with EPA’s children’s health policy, EPA stated that OCHP

works with the Office of Policy and the program offices to assure a 

consistent approach for documenting these decisions as part of the ADP. 

In response to our recommendation that the EPA Administrator reaffirm 

the 1995 Policy on Evaluating Health Risks to Children to clarify the intent 

of the policy to reflect the best available science, emphasize the 

importance of using applicable guidance, and reiterate EPA’s 

commitment to protecting children’s health, EPA stated that it concurred. 

In response to our recommendation that the EPA Administrator direct 

OCHP and OPP to establish procedures to identify tolerance decisions 

that could pose a significant risk to children’s health and provide 

opportunities for OCHP involvement consistent with the Administrator’s 

2010 memorandum, EPA acknowledged the need for continued 

coordination and improved communication between OCHP and OPP. 

EPA noted that although OCHP does not participate in each tolerance 

decision, OPP continues to employ the framework set up to ensure that 

decisions appropriately consider children’s health. EPA also stated that 

OCHP and OPP plan to develop ways to improve coordination, 

information sharing, prioritization, and communication and to document 

the agreement that is reached, thereby ensuring continued and consistent 

implementation. While we are encouraged by this plan, we continue to 

believe, as stated in our report, that until OPP and OCHP establish 

procedures for collaborating, OCHP’s responsibilities regarding protecting 

children’s health in the area of pesticide tolerance decisions will remain 

unclear. 

Agency Comments 

and Our Evaluation
 

Page 54 GAO-13-254 EPA Children's Health

As agreed with your office, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Administrator of the 

Environmental Protection Agency, appropriate congressional committees, 

and other interested parties. In addition, the report will be available at no 

charge on the GAO website at http://www.gao.gov. 

If you or your staff members have any questions about this report, please

contact me at (202) 512-3841or trimbled@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 report are listed in appendix VII.

Sincerely yours, 

David C. Trimble

Director, Natural Resources and the Environment
Appendix I: Objectives, Scope, and 

Methodology

Page 55 GAO-13-254 EPA Children's Health

Our objectives were to determine (1) the extent to which the 

Environmental Protection Agency (EPA) has implemented our 2010 

recommendations concerning children’s health protection and (2) the role, 

if any, that the Office of Children’s Health Protection (OCHP) has played 

in ensuring that key EPA program offices consider children’s health 

protection in their regulatory activities. We also describe how OCHP has 

worked with external partners to leverage its resources to better protect 

children’s health.

To address our first objective, we reviewed and analyzed numerous EPA 

documents, including the EPA Administrator’s February 4, 2010, 

memorandum, EPA’s fiscal years 2011 to 2015 strategic plan, EPA’s 

1995 Children Health Protection policy, OCHP’s fiscal years 2011 to 2013 

strategic plan, EPA’s Cross-Cutting Fundamental Strategy: Working for 

Environmental Justice and Children’s Health, agency action plans, and 

OCHP progress reports. We also compiled and analyzed official 

correspondence between the EPA Administrator and the Children’s 

Health Protection Advisory Committee (CHPAC) on various children’s 

health protection issues. Moreover, we identified key elements of several 

EPA databases, including ADP Tracker and RAPIDS, to determine the 

extent that these databases contain information that addressed our 

recommendations. We interviewed officials from OCHP, Office of Policy, 

and regional offices concerning the status of GAO’s 2010 

recommendations on children’s health protection. We also spoke with the 

Co-Chairs of CHPAC to obtain their views on these recommendations.

Finally, we attended several CHPAC conferences held in November 2011 

and March 2012, respectively, to observe EPA involvement in CHPAC.

To address our second objective, and to better understand OCHP’s role 

and responsibilities in EPA’s Action Development Process (ADP), which 

the agency uses to develop rules, regulations, and other agency actions, 

we relied on OCHP’s analysis from fiscal year 2011 based on the 

measures included in its fiscal years 2011 to 2013 strategic plan. As of 

September 2011, there were 106 regulations listed in EPA’s publicly 

available regulatory tracking system, Reg DAART, 31 of which had not 

been completed and were marked by the lead program office as having a 

potential impact on children’s health. OCHP measured its office’s impact 

in ADP by determining whether an action that had been identified as 

having a potential impact on children’s health was “fully responsive” to 

Executive Order 13045 and EPA’s Children’s Health Policy in addressing 

children’s vulnerabilities. We chose to more closely examine 6 of the 31 

regulations that were completed shortly after the end of fiscal year 2011 

and were representative of a range of outcomes––from OCHP serving on 

Appendix I: Objectives, Scope, and 

Methodology 
Appendix I: Objectives, Scope, and 

Methodology

Page 56 GAO-13-254 EPA Children's Health

a workgroup for which the action was fully responsive to OCHP not 

serving on a workgroup for which the action was not fully responsive. For 

the 6 regulations we examined more closely, we interviewed the OCHP 

representative, when there was one, and the workgroup Chair from the 

lead program office, to understand the dynamics of the workgroup and 

the contribution that OCHP may have made to the development of these 

actions. In addition, we interviewed officials from OCHP, as well as from 

several program offices that serve as the lead on actions, which could 

have a potential impact on children’s health. These program offices 

included the Offices of Air, Water, Chemical Safety and Pollution 

Prevention, and Solid Waste and Emergency Response. We also 

interviewed officials from the Office of Policy, which is a core office in the 

ADP, according to EPA guidance. In addition to our general discussion 

about OCHP’s role in the ADP, we examined OCHP’s role in EPA’s 

implementation of two statutory requirements that explicitly require 

special consideration of children––the Safe Drinking Water Act (SDWA) 

and the Food Quality Protection Act (FQPA). We interviewed officials 

from the lead program offices in charge of following these statutes, the 

Office of Water and the Office of Pesticide Programs in the Office of 

Chemical Safety and Pollution Prevention. We discussed the extent to 

which these offices coordinate and communicate with OCHP in their 

decision-making processes, and the officials from these offices provided 

documentation, when available, to demonstrate the extent to which they 

consider children’s health in their decision making processes. We also 

interviewed OCHP officials to better understand the level of 

communication and collaboration between them and officials from the 

Office of Water and the Office of Pesticide Programs. To gain an outside 

perspective on the highly technical issue of how the Office of Pesticide 

Programs’ pesticide registration and tolerance decisions meet FQPA 

criteria to consider children’s exposure, we selected a nonprobability 

sample of eight academic, medical, and industry experts in the field of 

children’s environmental health, pesticide exposure, and implementation 

of FQPA to interview. We selected these eight experts based on several 

factors including their current representation on EPA’s CHPAC or EPA’s 

Pesticide Program Dialogue Committee (PPDC). The Office of Pesticide 

Programs (OPP) provided us with summary information from its ISTEP 

MS Access database that tracks the most recent FQPA safety factor 

applied in an EPA risk assessment from 1996—the year that FQPA was 

enacted—to 2012. We assessed the reliability of the summary data on 

these decisions by (1) reviewing existing information about the data and 

the system that produced them and (2) interviewing agency officials 

knowledgeable about the data. We determined that the data were 

sufficiently reliable for the purposes of this report.
Appendix I: Objectives, Scope, and 

Methodology

Page 57 GAO-13-254 EPA Children's Health

To address our third objective, we reviewed various EPA documents 

related to children’s health protection, including EPA’s healthy homes 

strategy, Advancing Healthy Housing: A Strategy for Action, and key 

voluntary guidance issued by EPA for schools: School Siting Guidelines 

and Voluntary Guidelines for States: Development and Implementation of 

a School Environmental Health Program. We also reviewed a draft 

presentation of the healthy homes website, scheduled to be launched in 

2013 by the Department of Housing and Urban Development, as well as 

information from the Association of Occupational and Environmental 

Clinics’ website on Pediatric Environmental Health Specialty Units and 

the role these units play in helping to improve the knowledge of health 

care providers on prenatal and childhood environmental exposures.

Moreover, we reviewed OCHP grant data from fiscal years 2011 and 

2012 associated with activities in support of children’s health protection, 

as well as OCHP progress reports highlighting the office’s 

accomplishments relative to activities outline in its strategic plan. We 

interviewed officials from OCHP, particularly officials within OCHP’s 

Program Implementation and Coordination Division and EPA’s Office of 

Budget about the external activities that support children’s health 

protections, as well as the resources dedicated to children’s healthrelated outreach and coordination. We interviewed representatives from 

several nongovernmental organizations, including representatives from 

the National Center for Health Housing, the Natural Resources Defense 

Council, the Health and Environment Program National Environmental 

Education Foundation, the Healthy Schools Network, Incorporated, and 

the 21 Century School Fund and Building Educational Success Together 

to obtain their views on the effectiveness of OCHP’s outreach and 

coordination efforts pertaining to children’s health.

We conducted this performance audit from November 2011 to August 

2013 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.
Appendix II: EPA Policy on Evaluating Health 

Risks to Children

Page 58 GAO-13-254 EPA Children's Health

Appendix II: EPA Policy on Evaluating Health 

Risks to Children
Appendix II: EPA Policy on Evaluating Health 

Risks to Children

Page 59 GAO-13-254 EPA Children's Health
Appendix II: EPA Policy on Evaluating Health 

Risks to Children

Page 60 GAO-13-254 EPA Children's Health
Appendix III: EPA Administrator’s February 

2010 Memorandum

Page 61 GAO-13-254 EPA Children's Health

Appendix III: EPA Administrator’s February 

2010 Memorandum
Appendix III: EPA Administrator’s February 

2010 Memorandum

Page 62 GAO-13-254 EPA Children's Health
Appendix IV: Office of Children’s Health 

Protection’s Involvement in Agency Actions in 

Fiscal Year 2011

Page 63 GAO-13-254 EPA Children's Health

Table 1 depicts ongoing EPA actions in fiscal year 2011 that program 

offices identified as having a potential impact on children’s health. During 

this time period OCHP was involved in 21 of the 31 workgroups 

addressing these actions. There were four program offices that had the 

lead role in the development of these EPA actions, as depicted below. 

Table 1: Agency Actions Addressing Children’s Health in Fiscal Year 2011 

Agency action

OCHP on 

workgroup?

Lead

program office 

Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel 

Standards

Yes OAR

Formaldehyde Emissions Standards for Composite Wood Products Yes OCSPP 

Lead Emissions from Piston-Engine Aircraft Using Leaded Aviation Gasoline Yes OAR

Lead Wheel Weights; Regulatory Investigation Yes OCSPP 

*Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, 

and Painting Program (completed 8/11)

Yes OCSPP 

Lead; Renovation, Repair, and Painting Program for Public and Commercial Buildings Yes OCSPP 

Lead; Residential Lead Dust Hazard Standards Yes OCSPP 

Long-Chain Perfluorinated Chemicals (LCPFCs); Regulation(s) Under TSCA Yes OCSPP 

National Primary Drinking Water Regulations for Lead and Copper: Regulatory 

Revisions

Yes OW

National Primary Drinking Water Regulations: Regulation of Perchlorate Yes OW

Pesticides; Agricultural Worker Protection Standard Revisions Yes OCSPP 

Pesticides; Certification of Pesticide Applicators Yes OCSPP 

*Review of the National Ambient Air Quality Standards for Carbon Monoxide 

(completed 8/11)

Yes OAR

Review of the National Ambient Air Quality Standards for Lead Yes OAR

Review of the National Ambient Air Quality Standards for Ozone Yes OAR

Review of the National Ambient Qir Quality Standards for Particulate Matter Yes OAR

*Revision to Pb Ambient Air Monitoring Requirements (completed 12/10) Yes OAR

Revisions to EPA’s Rule on Protections for Subjects in Human Research Involving 

Pesticides

Yes OCSPP 

*Control of Greenhouse Gas Emissions from Medium and Heavy-Duty Vehicles 

(completed 9/11) 

Yes OAR

Joint Rulemaking to Establish 2017 and Later Model Year Light Duty Vehicle GHG 

Emissions and CAFÉ Standards

Yes OAR

Reconsideration of the 2008 Ozone Primary and Secondary National Ambient Air 

Quality Standards

Yes OAR

Mercury; Regulation of Use in Certain Products No OCSPP 

*NESHAP for Primary Lead Smelting (completed 11/11) No OAR

Addition of Vapor Intrusion Component to the Hazard Ranking System (HRS) No OSWER

Appendix IV: Office of Children’s Health 

Protection’s Involvement in Agency Actions 

in Fiscal Year 2011
Appendix IV: Office of Children’s Health 

Protection’s Involvement in Agency Actions in 

Fiscal Year 2011

Page 64 GAO-13-254 EPA Children's Health

Agency action

OCHP on 

workgroup?

Lead

program office 

NESHAP: Mercury Cell Chlor-Alkali Plants - Amendments No OAR

Remand of Halogenated Solvent Cleaning Final Residual Risk Rule No OAR

*Residual Risk and Technology Review for Secondary Lead Smelters NESHAP 

(completed 1/12)

No OAR

Risk and Technology Review for Ferroalloys Production No OAR

Risk and Technology Review for National Emission Standards for Hazardous Air 

Pollutants from the Pulp and Paper Industry

No OAR

Rulemaking on the Definition of Solid Waste No OSWER

Standards for the Management of Coal Combustion Residuals Generated by 

Commercial Electric Power Producers

No OSWER

Source: EPA Office of Children’s Health Protection.

The * designates agency actions that were finalized shortly after fiscal year 2011 during the time 

period of GAO’s review. GAO examined these actions more closely by interviewing workgroup chairs 

from the lead program offices and relevant OCHP program representatives. We refer to these actions 

in the body of the report. 

Note: The acronyms in the above table represent the following EPA program offices: OAR, Office of 

Air and Radiation; OSCPP, Office of Chemical Safety and Pollution Prevention; OW, Office of Water; 

and OSWER, Office of Solid Waste and Emergency Response.
Appendix V: FQPA Tolerance Decisions by 

OPP for Fiscal Year 2011

Page 65 GAO-13-254 EPA Children's Health

OPP officials provided us with the rationale associated with tolerance 

decisions for one year— fiscal year 2011. OPP provided a summary table 

listing each tolerance decision, the FQPA safety factor applied, and a 

phrase indicating the rationale only for those tolerance decisions where 

OPP retained all (default 10-fold) or part (3-fold) of the FQPA safety 

factor.1 The fiscal year 2011 data indicated all the FQPA safety factor 

decisions to retain all or part of the safety factor were made based on one 

of the following three rationales:

(1) the use of a “lowest observed adverse effect level (LOAEL)” instead of 

a “no observed adverse effect level;”

2 for the three 3-fold safety factor 

decisions in fiscal year 2011, this was the reason cited;

(2) a data gap, meaning one or more required toxicity study was not 

complete, such as an inhalation study or developmental toxicity study; 

and

(3) studies did not test the required duration of exposure, and 

extrapolation was required.

In fiscal year 2011 all but 9 of the 57 tolerance decisions applied a 1-fold 

safety factor. For 3 of the 9 decisions, a 3-fold safety factor was applied, 

and all of them were due to the use of a LOAEL. For the remaining 6 

decisions, all 4 applied a 10-fold safety factor. Of the 6 10-fold safety 

factor decisions, 1 was due to a LOAEL, 4 were due to a data gap, and 1 

was due to studies that did not test the required duration of exposure.

 

1

OPP officials did not provide similar rationale for every 1-fold decision from fiscal year 

2011 in the written documentation provided to GAO. 

2

According to EPA, lowest observed adverse effect level is the lowest dose in a toxicity 

study resulting in adverse health effects. Conversely, no observed adverse effect level is 

the highest dose in a toxicity study that does not result in adverse health effects and thus 

does not cause observable harm.

Appendix V: FQPA Tolerance Decisions by 

OPP for Fiscal Year 2011
Appendix VI: Comments from the 

Environmental Protection Agency

Page 66 GAO-13-254 EPA Children's Health

Appendix VI: Comments from the 

Environmental Protection Agency
Appendix VI: Comments from the 

Environmental Protection Agency

Page 67 GAO-13-254 EPA Children's Health
Appendix VI: Comments from the 

Environmental Protection Agency

Page 68 GAO-13-254 EPA Children's Health
Appendix VI: Comments from the 

Environmental Protection Agency

Page 69 GAO-13-254 EPA Children's Health
Appendix VI: Comments from the 

Environmental Protection Agency

Page 70 GAO-13-254 EPA Children's Health
Appendix VII: GAO Contact and Staff 

Acknowledgments

Page 71 GAO-13-254 EPA Children's Health

David C. Trimble, (202) 512-3841 or trimbled@gao.gov

In addition to the individual named above, Diane B. Raynes, Assistant 

Director; Elizabeth Beardsley; Mark Braza; John C. Johnson; Celia 

Mendive; and Amy Ward-Meier made significant contributions to this 

report. Cheryl Arvidson, Armetha Liles, Cynthia Norris, and Kiki 

Theodoropoulos also made important contributions to this report.

Appendix VII: GAO Contact and Staff 

Acknowledgments 

GAO Contact 

Staff 

Acknowledgments 

(361349)
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