This is the accessible text file for GAO report number GAO-10-205
entitled 'Environmental Health: High-level Strategy and Leadership
Needed to Continue Progress toward Protecting Children from
Environmental Threats' which was released on March 17, 2010.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as
part of a longer term project to improve GAO products' accessibility.
Every attempt has been made to maintain the structural and data
integrity of the original printed product. Accessibility features,
such as text descriptions of tables, consecutively numbered footnotes
placed at the end of the file, and the text of agency comment letters,
are provided but may not exactly duplicate the presentation or format
of the printed version. The portable document format (PDF) file is an
exact electronic replica of the printed version. We welcome your
feedback. Please E-mail your comments regarding the contents or
accessibility features of this document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
January 2010:
Environmental Health:
High-level Strategy and Leadership Needed to Continue Progress toward
Protecting Children from Environmental Threats:
GAO-10-205:
GAO Highlights:
Highlights of GAO-10-205, a report to congressional requesters.
Why GAO Did This Study:
Exposure to toxic chemicals or environmental pollutants may harm the
health of the nation’s 74 million children and contribute to increases
in asthma and developmental impairments. In 2007, 66 percent of
children lived in counties exceeding allowable levels for at least one
of the six principal air pollutants that cause or aggravate asthma,
contributing to medical costs of $3.2 billion per year, according to
the Centers for Disease Control and Prevention.
In 1997, Executive Order 13045 mandated that agencies place a high
priority on children’s risks and required that policies, programs,
activities, and standards address those risks. In response, the
Environmental Protection Agency (EPA) created the Office of Children’s
Health Protection and convened the Children’s Health Protection
Advisory Committee.
This report assesses the extent to which EPA has institutionalized
consideration of children’s health through (1) strategies and
priorities, (2) key offices and other child-focused resources, and (3)
participation in interagency efforts. GAO reviewed numerous documents
and met with EPA and other officials for this report.
What GAO Found:
EPA has developed policies and guidance to consider children, but it
has not maintained attention to children through agency strategies and
priorities. In 1996, EPA created a national agenda on children’s
health, and its 1997 and 2000 strategic plans highlighted children’s
health as a key cross-agency program. As a result, the agency’s
research advanced the understanding of children’s vulnerabilities.
However, EPA has not updated the agenda since 1996, and the focus on
children is absent from the 2003, 2006, and September 2009 draft
strategic plans.
EPA has not fully used the Office of Children’s Health Protection and
other child-focused resources. The active involvement of managers from
the office and experts from the Children’s Health Protection Advisory
Committee has been lacking, as has the involvement of key staff
throughout EPA. Although EPA now has a new Director of Children’s
Health, the office had not had consistent leadership since 2002,
hampering its ability to support and facilitate agencywide efforts and
elevate matters of importance with senior officials. For example, a
previous director established workgroups to bring together officials
from the program offices and the children’s health office, but a
subsequent acting director eliminated these groups, effectively
halting work on a key set of children’s health recommendations. In
addition, the regional children’s health coordinators—who provide
outreach and coordination for EPA—have no national strategy or
dedicated resources. Finally, the advisory committee has provided
hundreds of recommendations, but EPA has requested advice on draft
regulations only three times in the last decade.
While EPA leadership is key to national efforts to protect children
from environmental threats, EPA’s efforts have been hampered by the
expiration in 2005 of certain provisions in the executive order. For
example, the Task Force on Children’s Environmental Health provided
EPA with a forum for interagency leadership on important federal
efforts, such as the National Children’s Study. It also provided
biennial reports that helped establish federal research priorities.
Figure: Children Are Exposed to Many Sources of Potentially-harmful
Environmental Pollutants:
[Refer to PDF for image: illustration]
Infant/Young Child: Exposures for the infant and young child can occur
through all environmental media. When breastfed, the mother’s exposure
to environmental media can be an additional source of exposure to the
infant.
Mother:
Air;
Water;
Diet;
Physical factors;
Other.
Infant/young child:
Breast milk;
Air (inhalation);
Water (ingestion, inhalation, dermal);
Diet (ingestion, dermal);
Physical factors;
Other (ingestion, inhalation, dermal).
Source: EPA, A Framework For Assessing Health Risks of Environmental
Exposure to Children (2006).
[End of figure]
What GAO Recommends:
GAO recommends improvements to help EPA protect children, and EPA
agreed to implement them. GAO also suggests that Congress consider
reinstating a government-wide task force on children’s environmental
health.
View [hyperlink, http://www.gao.gov/products/GAO-10-205] or key
components. For more information, contact John Stephenson at (202) 512-
3841 or stephensonj@gao.gov.
[End of section]
Contents:
Letter:
Background:
EPA Has Not Focused Attention on Children's Health in Agencywide
Priorities, Strategies, and Rulemakings:
In Recent Years, EPA Has Not Fully Utilized Its Office of Children's
Health and Other Child-Focused Resources:
Opportunities Exist for EPA to Lead and Coordinate National Efforts to
Protect Children from Environmental Threats:
Conclusions:
Recommendations for Executive Action:
Matter for Congressional Consideration:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: EPA Policy on Evaluating Health Risks to Children:
Appendix III: Executive Order 13045 and Amendments:
Appendix IV: EPA Regulations Subject to Executive Order 13045:
Appendix V: Comments from the Environmental Protection Agency:
Appendix VIGAO Contact and Staff Acknowledgments:
Tables:
Table 1: Provisions in Selected Environmental Statutes Expressly
Concerning Children or Other Susceptible Subgroups:
Table 2: Priorities From EPA's National Agenda and Examples of Related
Actions:
Table 3: Placement of EPA's Regional Children's Health Coordinators
within the Offices of the Regional Administrator:
Table 4: Key Physical Environment and Safety Indicators of Children's
Well-Being, 2009:
Table 5: Summary of Commitments and U.S. Implementation of the 1997
Miami Declaration, as of 2002:
Table 6: EPA Regulations Subject to Executive Order 13045:
Figures:
Figure 1: Exposure Routes and Levels Change During Major Developmental
Periods Of Childhood:
Figure 2: Steps Where Children Are Considered in the EPA Rulemaking
Process:
Figure 3: EPA Regional Children's Environmental Health Coordinator
Staffing Levels by Region, in FTEs:
Figure 4: Number of Children's Health Protection Advisory Committee
Recommendations by Category:
Abbreviations:
ACE: America's Children and the Environment:
Advisory Committee: Children's Health Protection Advisory Committee:
CDC: Centers for Disease Control and Prevention:
EPA: Environmental Protection Agency:
Executive Order: Executive Order 13045--Protection of Children from
Environmental Health Risks and Safety Risks:
Healthy SEAT: Healthy Schools Environments Assessment Tool:
Interagency Forum: Federal Interagency Forum on Child and Family
Statistics:
Miami Declaration: Declaration of the Environmental Leaders of the
Eight on Children's Environmental Health:
NAAQS: National Ambient Air Quality Standards:
National Agenda: National Agenda to Protect Children's Health from
Environmental Threats:
Office of Children's Health: Office of Children's Health Protection:
OMB: Office of Management and Budget:
RAPIDS: Rule and Policy Information Development System:
Task Force: Task Force on Environmental Health Risks and Safety Risks
to Children:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
January 28, 2010:
The Honorable Barbara Boxer:
Chairman:
Committee on Environment and Public Works:
United States Senate:
The Honorable Amy Klobuchar:
Chairman:
Subcommittee on Children's Health:
Committee on Environment and Public Works:
United States Senate:
Children face disproportionate health risks from environmental
contaminants such as pollution in air, lead paint in homes, pesticide
residues on food, and treatment-resistant microbes in drinking water.
Such hazards contribute to asthma, cancer, neurodevelopmental
disorders, and other diseases, and many of the nation's 74 million
children are exposed to them daily. In 2007, for example, 66 percent
of children lived in counties where air exceeded one or more of the
six principal pollutants.[Footnote 1] Two of them--ozone and
particulate matter--are known to cause or aggravate respiratory
diseases such as asthma. According to the Centers for Disease Control
and Prevention (CDC), asthma is the third most common cause of
hospitalizations for children, resulting in $3.2 billion for treatment
and 14 million days of school lost annually.
The environment's effect on children's health is complex, and
scientists' understanding has continued to evolve. It can be
challenging to assess the contribution of environmental exposures to
childhood illnesses, because factors such as family history,
nutrition, and socioeconomic factors also contribute. Nonetheless,
scientists agree that children often are more significantly affected
by environmental risks from exposure to air pollution, toxic
chemicals, and the disease-transmitting vectors that are expected to
increase with global warming. Research has also shown that childhood
exposures to environmental contaminants may affect risk of diseases,
such as cancer, later in life.
In the late 1990s, the federal government took several steps to make
children's environmental health a priority. In April 1997, the
President signed Executive Order 13045--Protection of Children from
Environmental Health Risks and Safety Risks (Executive Order), which
mandated a concerted federal effort to address children's
environmental health and safety risks. The Executive Order
established, among other things, an interagency Task Force on
Environmental Health Risks and Safety Risks to Children (Task Force)
and charged it with recommending strategies to the President for
protecting children's health and safety. Also in 1997, the
Environmental Protection Agency (EPA) created the Office of Children's
Health Protection (Office of Children's Health) to support the
agency's efforts and formed the Children's Health Protection Advisory
Committee (Advisory Committee) to provide advice, information, and
recommendations to assist the agency in the development of
regulations, guidance, and policies relevant to children's health.
[Footnote 2]
EPA's Advisory Committee and the EPA Office of Inspector General have
raised concerns about whether the agency has continued to maintain its
earlier focus on protecting children or capitalized on opportunities
to tackle some significant and emerging environmental health
challenges. For example, the Advisory Committee wrote to the EPA
Administrator in April 2007 to reflect on EPA's achievements in the 10
years since the Executive Order was signed. The committee cited
successes such as increased margins of safety for pesticides mandated
under the Food Quality Protection Act and the creation of the National
Children's Study. However, the Advisory Committee also expressed
serious concerns about EPA's continued lack of focus on children's
environmental health issues and the lack of progress in addressing the
committee's many recommendations. The EPA Inspector General had also
raised many of those concerns in 2004.[Footnote 3]
To address concerns about EPA's focus on children, you asked that we
assess the agency's consideration of children's environmental health.
In September 2008, we testified on our preliminary assessment of EPA's
efforts to address children's environmental health, focusing on the
Advisory Committee.[Footnote 4] This report completes our work for
you, addressing more broadly the extent to which EPA has
institutionalized the protection of children's health from
environmental risks through (1) agency priorities, strategies, and
rulemakings, including implementation of Executive Order 13045; (2)
the use of key offices and other child-focused resources, such as the
Office of Children's Health and the Advisory Committee; and (3)
involvement in federal interagency efforts to protect children from
current and emerging environmental threats.
To address those objectives, we interviewed officials from multiple
EPA program offices most directly involved with children's health
issues and referred to long-established quality management criteria
from the Government Performance and Results Act.[Footnote 5] To assess
the extent that EPA prioritized children's health in its agencywide
strategies and goals, we reviewed key EPA children's health-related
policies, strategic and performance plans, and guidance documents. To
assess the implementation of the Executive Order through EPA's
rulemaking process, we reviewed regulations subject to the regulatory
requirements of the order, as well as internal workgroup documents
detailing EPA's rulemaking--National Ambient Air Quality Standards for
Particulate Matter--published in October 2006. To assess EPA's use of
its Advisory Committee, we analyzed documents--including meeting
agendas, letters from the Advisory Committee to the EPA Administrator,
and EPA's response letters. To examine EPA's involvement in national
children's health efforts, we identified the accomplishments of the
Task Force that EPA co-chaired, and we reviewed reports from groups
such as the Federal Interagency Forum on Child and Family Statistics
(Interagency Forum). Appendix I provides a more detailed description
of our scope and methodology. We conducted this performance audit from
November 2008 through January 2010 in accordance with generally
accepted government auditing standards. Those standards require that
we plan and perform the audit to obtain sufficient, appropriate
evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the
evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
Background:
The following section discusses issues related to children's
environmental health risks and key actions that EPA, the President,
and Congress took in the early 1990s to help address those risks.
Children's Environmental Health Risks:
Children are often disproportionately affected by environmental
contaminants, such as pesticides and lead, for many reasons, including
greater exposure levels, unique exposure pathways, and greater
vulnerability due to their still-developing bodies. For example, EPA
noted that children may receive higher doses of contaminants, because
they spend more time close to the ground; engage in more hand-to-mouth
activities; and breathe more air, drink more water, and consume more
food in proportion to their body weight than adults. Contaminants may
also affect children disproportionately because of their unique
exposure routes such as transplacental and breast milk. Figure 1
illustrates the relevant exposure routes during three major
developmental periods of childhood.
Figure 1: Exposure Routes and Levels Change During Major Developmental
Periods Of Childhood:
[Refer to PDF for image: illustration]
Prenatal:
All exposures to the fetus occur transplancentally or via physical
factors. The mother’s exposure to environmental media can be a
significant source of exposure for environmental media for the fetus.
Mother:
Air;
Water;
Diet;
Physical factors;
Other.
Fetus:
Transplacental.
Infant/Young child:
Exposures for the infant and young child can occur through all
environmental media. When breastfed, the mother’s exposure to
environmental media can be an additional source of exposure to the
infant.
Mother:
Air;
Water;
Diet;
Physical factors;
Other.
Infant/young child:
Breast milk;
Air (inhalation);
Water (ingestion, inhalation, dermal);
Diet (ingestion, dermal);
Physical factors;
Other (ingestion, inhalation, dermal).
Older child/Adolescent:
Exposures for the child and adolescent can occur through all
environmental media. The mother’s exposure is no longer a factor for
the child.
Older child/Adolescent:
Air (inhalation);
Water (ingestion, inhalation, dermal);
Diet (ingestion, dermal);
Physical factors;
Other (ingestion, inhalation, dermal).
Source: EPA, A Framework For Assessing Health Risks of Environmental
Exposure to Children (2006).
[End of figure]
Children also are more vulnerable than adults because of the relative
immaturity of their biochemical and physiological systems. For
example, air pollutants that would produce only slight breathing
difficulties in adults may contribute to a more serious breathing
problem in young children because of their smaller airways. Finally,
EPA has noted that children have limited ability to communicate and
urge action about their environment, so others must act on their
behalf.
In 1993, the National Academy of Sciences summarized the state of the
science concerning the effects of environmental contaminants on
children's health and helped institutionalize the idea that children
are not "little adults."[Footnote 6] That groundbreaking study
outlined some of the profound differences between children and adults
and was followed, in 1996, by congressional enactment of the Food
Quality Protection Act, which mandated use of a 10-fold safety factor
for children in setting pesticide residue tolerances.[Footnote 7]
Since the early 1990s, scientists have expanded our understanding of
environmental health consequences beyond childhood diseases and
disorders and began examining how childhood exposures affect people
throughout all lifestages. The term lifestage refers to a
distinguishable time frame in an individual's life characterized by
unique and relatively stable behavioral and physiological
characteristics that are associated with development and growth. EPA
now views childhood as a sequence of lifestages from conception
through fetal development, infancy, and adolescence, rather than
considering children as a subpopulation.[Footnote 8] In its 2005
Guidance on Selecting Age Groups for Monitoring and Assessing
Childhood Exposures to Environmental Contaminants, EPA recommended use
of the following childhood age groups for assessing risk from
environmental exposures:
* age groups less than 12 months old include: birth to <1 month, 1 to
<3 months, 3 to <6 months, and 6 to <12 months; and:
* age groups greater than 12 months old include: 1 to <2 years, 2 to
<3 years, 3 to <6 years, 6 to <11 years, 11 to <16 years, and 16 to
<21 years.
According to EPA guidance, other lifestages, including pregnancy,
nursing, and old age, may also be important to consider when assessing
human exposure and health risk.
In addition to the growing awareness about the impact that childhood
exposures may have on health risks throughout later lifestages,
awareness has also grown about the linkage between children's
environmental health and environmental justice issues such as health
disparities seen in affected population groups. The Interagency Forum
reported that the environmental health risks that disproportionately
affect children are likely to disproportionately affect minority and
low-income children because of demographic trends in the United
States.[Footnote 9] According to the U.S. Census Bureau, there were
73.9 million children ages 0 to 17 in the United States in 2008, 1.5
million more than in 2000. Although the number of children living in
the United States has grown, the percentage of children has decreased
steadily, from a peak of 36 percent at the end of the "baby boom" in
the mid-1960s to a current 24 percent--where it is expected to remain
through 2020. At the same time, the racial and ethnic composition of
the country's children is expected to diversify.
EPA's Early Actions to Institutionalize Children's Environmental
Health:
EPA's mission is to protect human health and the environment and, as a
result of mounting evidence about the special vulnerabilities of the
developing fetus and child, the agency took actions to emphasize
protection of children from environmental exposures. In 1995, EPA
established an agencywide Policy on Evaluating Health Risks to
Children, directing EPA staff to consistently and explicitly consider
risks to infants and children as a part of risk assessments generated
during its decision-making processes, and when setting standards to
protect public health and the environment (see appendix 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, documenting
EPA's plans to achieve the following seven goals:
1. Ensure that all standards set by EPA are protective of any
heightened risks faced by children.
2. Develop a scientific research strategy focused on the gaps in
knowledge regarding child-specific susceptibility and exposure to
environmental pollutants.
3. Develop new, comprehensive policies to address cumulative and
simultaneous exposures faced by children.
4. Expand community right-to-know allowing families to make informed
choices concerning environmental exposures to their children.
5. Encourage parental responsibility for protecting their children
from environmental health threats by providing them with basic
information.
6. Encourage and expand educational efforts with health care providers
and environmental professionals so they can identify, prevent, and
reduce environmental health threats to children.
7. Provide the necessary funding to address children's environmental
health as a top priority among relative health risks.
In 1997, EPA also established the Office of Children's Health, within
the Office of the Administrator, to support and facilitate the
agency's efforts to implement the National Agenda as well as the
Executive Order. The office's mission is to "make the protection of
children's health a fundamental goal of public health and
environmental protection in the United States and around the world."
The office is not directly responsible for implementing or overseeing
any EPA programs and instead carries out its mission by supporting and
facilitating the work of other EPA offices, raising awareness and
educating the public, participating in agency workgroups, and
providing grant money that serves to assist communities in expanding
awareness about children's health issues. To inform its various
initiatives related to children's health, EPA also established the
Advisory Committee in 1997. Through the Committee, leading
researchers, academics, health care providers, nongovernmental
organizations, industry representatives, as well as state and local
government representatives advise EPA on regulations, research, and
communications issues important to children's health.
Executive Order 13045--Protection of Children from Environmental
Health Risks and Safety Risks:
The President issued the Executive Order in April 1997, which
established a broad policy for a concerted federal effort to address
children's environmental health risks and safety risks.[Footnote 10]
The Executive Order required each federal agency to (1) make it a high
priority to identify and assess environmental health risks and safety
risks that may disproportionately affect children and (2) ensure that
its policies, programs, activities, and standards address
disproportionate risks to children that result from environmental
health risks or safety risks (see appendix III). The Executive Order
has four other key provisions relating to regulatory requirements,
interagency coordination and strategies, research coordination and
integration, and tracking of children's health indicators. With regard
to regulations, the Executive Order requires federal agencies to
develop two pieces of information as part of the rulemaking process:
(1) an evaluation of the environmental health or safety effects on
children of the planned rule; and (2) an explanation of why the
planned rule is preferable to other potentially effective and
reasonably feasible alternatives considered by the agency. The
requirements of the Executive Order are among many broadly applicable
regulatory requirements established by statutes and executive orders
with which agencies must generally comply when issuing rulemakings.
Individual rulemakings only trigger the specific analytical and
procedural requirements of the Executive Order if they fall within
specified conditions or impact thresholds. The requirements of the
Executive Order are triggered if a rulemaking is likely to result in a
rule that (1) meets the economic impact threshold, such as by having
an annual impact of $100 million or more, and (2) concerns an
environmental health risk or safety risk that an agency has reason to
believe may disproportionately affect children.
Statutory Requirements to Consider Children's Environmental Health:
In addition to the broad mandate in the Executive Order, EPA and the
Agency for Toxic Substances and Disease Registry are directed by
Congress to consider children or other vulnerable populations in
several environmental statutes. Table 1 lists those statutes and their
express provisions related to children's health.
Table 1: Provisions in Selected Environmental Statutes Expressly
Concerning Children or Other Susceptible Subgroups:
Statute: Food Quality Protection Act 21 U.S.C. §§ 321, 331, 333, 342,
346a;
Regulated activity: Pesticide residues on raw and processed food;
Extent to which statute explicitly requires special consideration of
children or susceptible subgroups in decision making: In establishing
tolerances and exemptions, EPA must consider infant and children's
exposure, susceptibility, and cumulative effect, and apply a 10-fold
margin of safety (unless data support a different margin);
ensure that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to the pesticide
chemical residue; and publish a specific determination of safety.[A];
Also, factors to be considered include exposure and sensitivity of
subgroups.[B]
Statute: Safe Drinking Water Act; 42 U.S.C. §§ 300f-300j-18;
Regulated activity: Public drinking water;
Extent to which statute explicitly requires special consideration of
children or susceptible subgroups in decision making: In selecting a
maximum contaminant level, EPA must analyze the effects on groups such
as infants, children, pregnant women, the elderly, individuals with a
history of serious illness, or other subpopulations that are
identified as likely to be at greater risk, and subject the analysis
to public notice and comment[C]; In selecting unregulated contaminants
for consideration of regulation, EPA must consider the effects on
subgroups that comprise a meaningful portion of the general population
(such as infants, children, pregnant women, the elderly, individuals
with a history of serious illness, or other subpopulations) at higher
risk than the general population.[D]
Statute: Federal Insecticide, Fungicide and Rodenticide Act;
7 U.S.C. §§ 136-136y;
Regulated activity: Pesticide registrations;
Extent to which statute explicitly requires special consideration of
children or susceptible subgroups in decision making: If pesticide is
for use on food, then as part of its registration and reregistration,
a tolerance or exemption must be established or reviewed under FQPA;
see above[E]; EPA is authorized to establish packaging standards for
pesticides.[F]
Statute: Comprehensive Environmental Response, Compensation, and
Liability Act; 42 U.S.C. §§ 9601-9675;
Regulated activity: Hazardous waste sites;
Extent to which statute explicitly requires special consideration of
children or susceptible subgroups in decision making: Under response
authorities, health risk assessments conducted by the Agency for Toxic
Substances and Disease Registry (ATSDR) are to consider susceptibility
of the community[G]; ATSDR is also directed to conduct medical
monitoring of subgroups at risk.[H]
Statute: Resource Conservation and Recovery Act; 42 U.S.C. §§ 6901-
6992k;
Regulated activity: Hazardous waste handling, treatment, storage,
disposal;
Extent to which statute explicitly requires special consideration of
children or susceptible subgroups in decision making: In the context
of hazardous waste landfill permits, where ATSDR is asked to do health
assessments, the agency is to consider susceptibility of the community
in conducting assessments.[I]
Source: GAO.
Note: Statutes were reviewed as amended, and are cited to the
codification.
[A] 21 U.S.C. § 346a(b)(2)(B)(vi), (C) (tolerances), (c)(2)(B)
(exemptions). There are limited exceptions (e.g., use safer than
nonuse; unavoidable residues).
[B] 21 U.S.C. § 346a(b)(2)(D)(vi), (vii).
[C] 42 U.S.C. § 300g-1(b)(3)(C)(i)(V).
[D] 42 U.S.C. § 300g-1(b)(1)(C).
[E7] U.S.C. §§ 136(bb), 136a(c)(5), 136a-1(g)(2)(E).
[F] 7 U.S.C. § 136w(c)(3).
[G] 42 U.S.C. § 9604(i)(6)(F).
[H] 42 U.S.C. § 9604(i)(9)(A).
[I] 42 U.S.C. § 6939a(f).
[End of table]
Other Key EPA Children's Environmental Health Protection Activities:
In 1998, EPA helped establish eight Centers for Children's
Environmental Health and Disease Prevention Research, with the long-
range goal of understanding how environmental factors affect
children's health and translating basic research findings into methods
and interventions to prevent adverse health outcomes. The program is
jointly funded by EPA, through its Science to Achieve Results grants
program, and the National Institute of Environmental Health Sciences,
with additional expertise and low-cost laboratory services provided by
CDC.[Footnote 11] The program is designed to foster research
collaboration among basic, clinical, and behavioral scientists with
participation from local communities.
In 1999, EPA--and the other members of the Task Force--explored the
feasibility of a longitudinal cohort study of environmental effects on
parents and children, and in 2000 Congress authorized the planning and
implementation of the National Children's Study as part of the
Children's Health Act of 2000.[Footnote 12] The study is designed to
examine the effects of environmental influences on the health and
development of 100,000 children across the United States, following
them from before birth until age 21, with the goal of improving the
health and well-being of children. EPA is one of a consortium of
federal partners currently leading the study that includes the U.S.
Department of Health and Human Services' National Institute of Child
Health and Human Development, National Institute of Environmental
Health Sciences of the National Institutes of Health, and CDC.
[Footnote 13]
In 2000, EPA published America's Children and the Environment (ACE), a
report that brought together quantitative information from a variety
of sources to show trends in environmental risk factors related to the
health and well-being of children in the United States. The ACE report
provides trend information on levels of environmental contaminants in
air, water, food, and soil; concentrations of contaminants measured in
the bodies of mothers and children; and childhood diseases that may be
influenced by environmental factors. In 2003, EPA published the second
ACE report, adding data for additional years; new measures for
important contaminants, exposures, and childhood illnesses; and
analysis of those measures by children's race, ethnicity, and family
income. Since 2006, EPA has periodically updated the report data on
its Web site.[Footnote 14] EPA is currently updating the ACE report's
measures and developing new priority topics, and it intends to publish
a new edition by the end of 2010.
EPA Strategic Plans--Goals and Performance Measures:
EPA first recognized children's environmental health as a cross-agency
program in its 1997 strategic plan and related annual performance
plans, which are required by the Government Performance and Results
Act. EPA's strategic plan defines its mission, goals, and means by
which it will measure progress in addressing specific problems or
challenges over the course of at least 5 years. It also describes
specific results the agency aims to achieve, what actions the agency
will take to realize those planned results, and how the agency will
deal with current and foreseeable internal and external challenges
that may hinder achieving results. An agency formulates its strategic
plan with input from the Office of Management and Budget (OMB);
Congress; the agency's personnel, partners, and stakeholders; and the
public. EPA's strategic plan also serves a number of important
management roles and functions related to achieving its mission, for
example allowing agency leadership to establish and communicate
priorities and direction through a strategic and unified vision. It
also is the foundation of the agency's planning system, for instance
providing direction for programmatic functions such as human resources
and budgeting, and serves to increase leadership accountability.
EPA Action Development Process and Related Children's Guidance:
EPA implements various environmental statutes in part through
rulemakings, which are guided by its Action Development Process that
helps the agency comply with legal requirements, executive orders,
directives, agency guidance, and national policies. EPA finalized the
current process in June 2004 to ensure that it uses quality
information to support its actions and that scientific, economic, and
policy issues are adequately addressed at the right stages in action
development.[Footnote 15] The process has five major stages, each of
which involves multiple steps. In the first stage, EPA assigns the
rulemaking to one of three tiers based on the required level of cross-
agency interactions and the nature of the anticipated issues,
including complexity, environmental and economic significance, and
external interest. According to agency guidance, EPA assigns
rulemakings that are based on a human risk assessment--including
assessments of environmental health risks to children--to tier 1 or
tier 2. In the second stage, EPA uses a standard process to develop
the proposed regulation and supporting analyses. In the third stage,
EPA submits a regulatory package to OMB and addresses OMB comments,
when required to do so under Executive Order 12866.[Footnote 16] In
the fourth stage, EPA requests the Administrator's signature and
publishes the draft regulation in the Federal Register. In the fifth
stage, EPA develops the final action and facilitates Congressional
review. In developing the final regulation, EPA repeats many of the
steps it followed to develop the draft regulation. The final step in
the process is to submit the final regulation to Congress and GAO.
In October 2006, EPA's Office of Policy Economics and Innovation
issued additional guidance to assist agency staff in integrating
children's health considerations into the process.[Footnote 17] The
children's guidance describes provisions of the Executive Order and
EPA's Policy on Evaluating Health Risks to Children. Figure 2
illustrates key steps in EPA's Action Development Process where
children are to be considered by the agency.
Figure 2: Steps Where Children Are Considered in the EPA Rulemaking
Process:
[Refer to PDF for image: illustration]
1. Cause for rulemaking: statute, court order, Presidential
initiative, or Administrator’s priority.
2. Tiering: EPA assigns rulemaking to tier 1 or tier 2.
3. Preliminary Analytic Blueprint prepared by workgroup (Workgroup
plans scope and content of children’s analyses).
4. Early Guidance.
* Key decision point involving input from senior management.
5. Detailed Analytic Blueprint (DABP) prepared by workgroup (Workgroup
plans scope and content of children’s analyses).
6. DABP approved by management.
* Key decision point involving input from senior management.
7. Workgroup undertakes analyses and consultation required by statutes
and develops regulatory options.
Requirement to consider children’s environmental health: Some statutes
(see table 1) and E.O. 13045 require children’s analyses.
8. Options Selection (Rulemakings vary considerably in the extent to
which children’s risks factor in key decision points).
* Key decision point involving input from senior management.
9. Proposed regulation and supporting documents prepared by workgroup.
10. Final Agency Review (Rulemakings vary considerably in the extent
to which children’s risks factor in key decision points).
11. EPA submits regulatory package to OMB if regulation is significant
under E.O. 12866.
Requirement to consider children’s environmental health: Regulations
subject to the regulatory requirements of E.O. 13045 are reviewed by
OMB.
* Key decision point involving input from senior management.
12. OMB Review: OMB has 90 days to review significant regulations[A].
Requirement to consider children’s environmental health: Regulations
subject to the regulatory requirements of E.O. 13045 are reviewed by
OMB.
13. Administrator signs regulation[B].
14. EPA publishes regulation in the Federal Register and opens public
docket[C].
15. Public comment period: typically lasts 60 days.
16. Final regulation developed by EPA[D].
Source: GAO analysis of EPA’s Action Development Process.
[A] EPA may request a one-time 30-day extension.
[B] The Administrator may delegate signature authority to an Assistant
or Associate Administrator or Regional Administrator.
[C] A docket can be established at any time during the rulemaking
process, but should open no later than the date of publication in the
Federal Register. A docket should contain all information relied upon
by EPA in developing an action.
[D] Developing the final regulation involves reconvening the workgroup
to evaluate comments received on the proposal and determine the
appropriate next steps for preparing the final action, which could
range from repeating all of the steps as outlined in the process for
preparing the proposal to only doing a subset of those steps.
[End of figure]
EPA Has Not Focused Attention on Children's Health in Agencywide
Priorities, Strategies, and Rulemakings:
EPA has not updated the National Agenda since it issued the priority-
setting document in 1996. EPA's 1997 and 2000 strategic plans included
children as an explicit goal or program, but the agency's subsequent
two plans showed a reduced emphasis on children. EPA has not
systematically evaluated or tracked how its rulemakings addressed
children's environmental health risks, and regulatory requirements in
the Executive Order have had minimal impact on EPA rulemakings.
EPA Has Not Updated the National Agenda in More than a Decade:
EPA has not updated the National Agenda to Protect Children's Health
from Environmental Threats in more than 10 years. Issued in 1996, the
National Agenda established children's environmental health as a top
priority and a central focus of all agency efforts. In it, EPA
articulated the agency's commitment to children's health by
identifying an array of environmental threats to children and
specifying a multifaceted approach to accomplishing its children's
health goals. The National Agenda also was the impetus for the
creation of EPA's Office of Children's Health, which was formed to
support the agency's implementation of the National Agenda. These
actions are consistent with our prior work on implementing change in
the federal government, which has shown that top leadership must
provide a clear, consistent rationale for change and develop a
framework that helps create a new culture. Moreover, the National
Agenda also helped to institutionalize the agency's commitment to the
issue. According to current and former officials from the Office of
Children's Health, the National Agenda and Executive Order helped
legitimize the office's importance across the rest of the agency.
Several demonstrable children's health-focused activities were
initiated shortly after the EPA Administrator who founded the Office
of Children's Health issued the National Agenda (see table 2). For
example, in 1999 the agency explored--through the Task Force--the
feasibility of a longitudinal cohort study of environmental effects on
parents and children, which Congress later established as the National
Children's Study.[Footnote 18] In 2000, EPA issued a strategy for
research on environmental risks to children that established EPA's
long-term program goals and documented its rationale.[Footnote 19] The
National Agenda also asserted EPA's leadership across the federal
government and called on partners in Congress, industry, health
professions, and interest groups to adopt and help EPA implement these
children's health priorities.
Table 2: Priorities From EPA's National Agenda and Examples of Related
Actions:
National Agenda priority:
1. Ensuring that EPA standards are protective of potentially
heightened risks faced by children;
Children's environmental health action:
* In 1997, EPA asked its Advisory Committee to recommend five existing
standards that may merit re-evaluation. In 1999, EPA identified eight
regulations and regulatory areas for review, including pesticide
tolerances and farm worker protection standards;
* In 1997, EPA set air standards for particulate matter and ozone to
provide additional health protection to 35 million children and set
standards for fine particulate matter for the first time;
* In 1998, EPA published a final Guidance for Rule Writers to risk
assessors and managers who are developing regulatory standards that
are specifically targeted at pregnant women, infants, and children.
National Agenda priority:
2. Identifying and expanding scientific research on child-specific
susceptibility to environmental pollutants;
Children's environmental health action:
* In 1998, EPA partnered with the National Institute of Environmental
Health Sciences (NIEHS) to establish children's health research
centers to promote research and intervention and prevention methods in
order to better understand how environmental factors affect children's
health;
* In 1999, EPA helped to initiate what became the National Children's
Study (see text above).
National Agenda priority:
3. Developing policies addressing cumulative and simultaneous
exposures;
Children's environmental health action:
In 1997, EPA published cumulative risk assessment guidance that
recommended the integration of multiple sources, effects, pathways,
stressors, and populations in risk assessments for which relevant data
are available, with emphasis on sensitive subgroups such as infants
and children.
National Agenda priority:
4. Expanding community right-to-know efforts;
Children's environmental health action:
EPA expanded public access to agency information on pollution,
particularly through the Internet, to help people prevent pollution in
their neighborhoods and protect the health of a community's children.
For instance, EPA developed a national listing of state fish
consumption advisories to make the advisories more accessible.
National Agenda priority:
5. Providing information to parents on environmental threats in homes,
schools, and communities;
Children's environmental health action:
In 1998, EPA began publication of a Children's Environmental Health
Yearbook to be a resource guide of EPA activities for the public.
National Agenda priority:
6. Educating health and environmental professionals to prevent and
reduce threats to children;
Children's environmental health action:
In 1998, EPA, in conjunction with the Agency for Toxic Substances and
Disease Registry, established Pediatric Environmental Health Specialty
Units to provide critical expertise to health care professionals,
parents, schools, and community groups on protecting children from
environmental hazards, as well as to work with federal, state, and
local agencies to address children's environmental health issues in
homes, schools, and communities.
National Agenda priority:
7. Funding to address children's environmental health as a top
priority among relative health risks;
Children's environmental health action:
Since 1998, EPA and NIEHS share responsibility for funding the
children's health research centers, with EPA providing half the
funding through its Science to Achieve Results program.
Source: GAO analysis of EPA documents.
[End of table]
EPA officials with whom we spoke recognized the importance of the
National Agenda for helping to institutionalize children's health as a
priority across EPA, noting that it gave children's health more
traction and consideration in EPA programs and activities. In its 2004
report, EPA's Inspector General stated that while EPA has taken steps
toward meeting the goals outlined in the agenda, with programs and
regional offices carrying out projects focused on children's
environmental health, there was no overall, coordinated strategy to
integrate the agency's efforts on behalf of children.[Footnote 20]
Moreover, as we have previously reported and testified, EPA took
actions that directly contradicted a National Agenda priority in
December 2006.[Footnote 21] Specifically, the agency finalized a
rulemaking that significantly reduced the amount of publicly available
information reported to the Toxics Release Inventory about toxic
chemicals released into air, water, and land. Ultimately, Congress
acted to overturn EPA's actions.[Footnote 22]
In the first few months of 2009, EPA's newly appointed Administrator
recommitted the agency to helping ensure protection of children's
environmental health, stating in a speech that children are a driving
force behind the agency's priorities.[Footnote 23] In July 2009, she
appointed a new Director of the Office of Children's Health and said
that the director will also serve as a key advisor in the
Administrator's office. In order to develop concrete ways to implement
the new commitment, the Administrator tasked the new director with
developing recommendations to improve regulatory and nonregulatory
consideration of children's environmental health across EPA. In
September 2009, the new director outlined the following five-part
approach to ensure protection of children's environmental health:
* Regulatory and policy development: EPA will work to ensure that
regulations--for example, National Ambient Air Quality Standards
(NAAQS)--provide for protection of children's environmental health. It
will also ensure that policies focus on health disparities among
different demographic groups of children, and their causes.
* Safe chemicals management: EPA will ensure that children, and other
susceptible populations such as the elderly, are considered in the
context of chemicals management programs and implementation and
potential reform of the Toxic Substances Control Act.[Footnote 24]
* Implementation of community-based children's health programs: EPA
will re-establish a pivotal and influential role in working with
tribes, states, and local governments to design and implement policies
that improve the environment and protect children.
* Research and science policy: EPA will work with internal and
external researchers to fill critical gaps in the understanding of
children's vulnerabilities, unique exposures, and health effects, and
will apply science policies that appropriately reflect uncertainties
in children's vulnerabilities in EPA risk assessments.
* Measuring effectiveness of EPA programs: EPA will update its report
America's Children and the Environment, which brings together
quantitative information from a variety of sources to show trends in
levels of environmental contaminants and concentrations of
contaminants in the bodies of mothers and children, among other things.
The director told us about some specific steps he plans to take within
the Office of Children's Health as part of the approach, including
shifting resources so that the office has more public health expertise
and realigning the office's focus to support the development of
regulations and child-specific programs. In addition, he said he was
confident the Administrator would begin to make other changes related
to children's health strategy, although he could not provide a time
frame or specific actions the agency had planned to implement such
changes. Nonetheless, the EPA Administrator has yet to formalize new
priorities in a visible and public way that contains specific actions
EPA intends to take, as it did in the National Agenda. In contrast,
EPA has publicly committed to improvements in other areas, such as
chemicals management for which the agency released in September 2009 a
comprehensive approach to enhance the agency's chemical program.
[Footnote 25]
EPA Recent Strategic Plans Indicate a Reduced Emphasis on Children's
Health:
EPA identified children's health as a cross-agency program in its 1997
and 2000 strategic plans.[Footnote 26] However, EPA's 2003 and 2006
(current) plans did not include children's health as an explicit goal
or program, indicating that the agency has placed less emphasis on
protecting children's health.[Footnote 27] The plans' goals and
measures are meant to make the key components of an organization's
mission explicit, thereby guiding officials in how to carry out the
mission. In keeping with the requirements of the Government
Performance and Results Act, EPA issued strategic plans setting forth
goals that reflected top Administrator priorities; the plans also
discuss cross-agency programs that cut across traditional media and
organizational boundaries to consider, with a more comprehensive view,
the risks posed to particular or vulnerable populations. EPA officials
said that the agency removed this cross-agency goal when it
streamlined its strategic plan from a 10-goal to a 5-goal structure,
which was done as a result of EPA and OMB priorities.[Footnote 28]
According to EPA officials, children are considered as part of the
plans' Goal 4, Healthy Communities and Ecosystems. The staff from the
Office of Children's Health told us they were not pleased with the
change to a 5-goal structure, because the subsequent strategic plans
no longer emphasized children's environmental health. In addition, the
office had previously developed its own draft strategic plan that
included a range of children's health performance measures and
demonstrated how such measures fit within EPA's overall strategic
plan. However, that work was not incorporated into, or referenced by,
the agencywide strategic plan, in part, because the office had limited
involvement in EPA's strategic planning process.
To help develop EPA's 2009 strategic plan, the agency held meetings in
2008 and 2009 to identify target areas for improvement. In the latest
draft of that plan that EPA provided to us, the agency identified
target areas for improvement--significant changes in strategy or
performance measurement that are critical for helping the agency
achieve and measure environmental and human health outcomes.[Footnote
29] We found that children's health was not included as a target area
in the draft strategic plan, and it is not yet clear to what extent
children's health will be addressed in the final plan, which is
subject to revision before the Administrator finalizes it in the
coming months. We also found that the Office of Children's Health was
not a lead office for developing the plan's goal for Healthy
Communities and Ecosystems. Development of this goal has been co-led
by EPA's Office of Prevention, Pesticides and Toxic Substances; Office
of Research and Development; and Office of Water. EPA planning
officials told us that staff from the Office of Children's Health
attended at least one development meeting for the healthy community
goal. However, the office staff said their input was not given much
weight, since three other offices were assigned the leadership role
for coordinating the goal's team. EPA officials said that a possible
reason the Office of Children's Health did not become central to the
process was that it is not directly responsible for implementing or
overseeing any of the programs and subobjectives under the Healthy
Communities and Ecosystems goal.
We recognize that EPA's strategic plan addresses five high-level goals
and related objectives that generally relate to major media goals such
as improving water quality or reducing chemical risks. Therefore, the
strategic plans contain subobjectives and strategic targets that
provide a higher degree of specificity and allow EPA to more clearly
express priorities. However, our analysis of EPA's last two strategic
plans found few subobjectives or strategic targets that explicitly
related to children's health.[Footnote 30] We have previously reported
on the need for a strategic planning framework to contain critical
elements such as performance goals that are indicative of agency
priorities and also are objective, quantifiable, and measurable; an
estimate of resources needed to meet performance goals; and an
evaluation plan that monitors the goals.[Footnote 31] EPA stated in
its 2006 strategic plan that the agency directs its efforts toward the
greatest threats in communities and the most sensitive populations,
including children, who may be disproportionately exposed to
environmental hazards. We found that only 2 of the 45 subobjectives
relate specifically to children's environmental health: (1) asthma and
(2) indoor air quality at schools.[Footnote 32] We also found that, of
the plan's 126 strategic targets, only 3 explicitly reference children
or related issues: (1) reducing the percentage of women of
childbearing age exposed to mercury, (2) eliminating lead poisoning,
and (3) reducing blood lead levels.
With regard to the draft 2009 strategic plan that EPA planning
officials provided us, 5 subobjectives (out of a total of 62)
specifically address children's environmental health--reducing (1)
exposure to asthma triggers, (2) indoor air contaminants at schools,
(3) the percentage of women of childbearing age with mercury blood
levels above safe thresholds, (4) blood lead levels in children, and
(5) pregnant women's exposure to persistent organic pollutants.
Furthermore, regarding EPA's draft 2009 strategic plan, we found that
the performance measures do not clearly measure children's health
progress or are not explicitly linked to children's health objectives.
Performance measures are indicators, statistics, or metrics used to
gauge program performance. Reliable and comprehensive performance
measures allow the agency to judge whether its performance targets are
reasonable and whether it is meeting them. Moreover, as we have
previously reported, strategic plans need to demonstrate that
crosscutting programs--such as those for protecting children's
environmental health--use the same performance measures across the
offices implementing the programs. Our analysis indicates that 4 of
the 12 performance measures (associated with the five subobjectives
EPA identified) explicitly consider children, and only one of them
measures a health outcome--the number of children ages 1 to 5 with
elevated blood lead levels. The other 11 measures either did not
directly measure children's health outcomes or were indirect proxy
measures. We also found that for half of the 12 performance measures,
the data or the data sources had inherent limitations. For example,
the data source supporting the measure for "taking all essential
actions to reduce exposure to indoor environmental asthma triggers"
does not cover half of EPA's target population--children from birth to
3 years old--the age group most susceptible to health effects from
secondhand tobacco smoke, a key asthma trigger according to CDC. EPA
officials acknowledged that the data gaps for some performance
measures are due a variety of reasons, including funding limitations.
They added that EPA cannot necessarily guarantee availability of all
the data used to support its performance measures, some of which are
provided by other agencies.
In contrast to the EPA's agencywide strategic plans, its Office of
Research and Development has consistently addressed children's
environmental health in its research plans. For example, working with
other program offices, the office has addressed children's health in
some of its multiyear research plans, which guide the direction of
research over 5 or more years. The office develops separate multiyear
plans on a variety of issues, including clean air, endocrine
disruptors, human health risk assessments,[Footnote 33] and human
health research. The Office of Research and Development uses these
multiyear plans to link its Annual Performance Plan, required under
the Government Performance and Results Act, to longer-range objectives
contained in EPA's strategic plan. In addition to these regular
planning efforts, the Office of Research and Development has also
developed strategies for addressing complex, cross-cutting programs,
such as children's health. For example, the office published a Human
Health Research Strategy in September 2003. Officials from the Office
of Research and Development told us that the office is considering
updating its August 2000 Strategy for Research on Environmental Risks
to Children, and has held preliminary discussions with the Office of
Children's Health.
The Office of Research and Development's Human Health Research Program
Multi-Year Plan is EPA's primary research plan for addressing
children's health, according to office officials. The plan supports
the office's human health research program, which also provides
methods to help reduce uncertainty in EPA's children's risk
assessments, among other things. In June 2006, the office published an
updated human health research plan for the years 2006 through 2013.
The plan is organized according to the program's four long-term goals
and explicitly addresses children's health in two of them. For
example, children's health is addressed in the goal to ensure that
"risk assessors and risk managers use the office's methods, models,
and data to characterize and provide adequate protection for
susceptible subpopulations." The plan considers children's health in
all three of the research tracks supporting that goal--lifestages,
methods for longitudinal research, and research on asthma.[Footnote
34] In fact, a generally positive review of the research plan by EPA's
Board of Scientific Counselors--which the agency established to
provide advice, information, and recommendations about its research
program--found that EPA may be overemphasizing children in its
research on susceptible subpopulations. The board recommended in its
December 2009 report that EPA redress research program imbalances
within the lifestage arm to match the strengths of its childhood
susceptibility research thrust with an expanded research program
addressing subgroups across the entire age range, including the
elderly.[Footnote 35]
EPA Has Not Evaluated or Consistently Documented How Its Rulemakings
Address Risks to Children:
EPA's 1995 policy directs the agency to consider the risks to infants
and children consistently and explicitly as part of risk assessments--
including those used to support rulemakings--or state clearly why it
did not. EPA cannot be assured that it has thoroughly addressed risks
to children, because it lacks a system for evaluating and documenting
how the agency has considered them in rulemakings. We identified three
examples. First, EPA implements the Executive Order, in part, through
its efforts to institutionalize its 1995 policy. However, EPA has not
evaluated the extent to which its risk assessments conform to this
policy.[Footnote 36] Officials from the Office of Children's Health
told us that significant information gaps remain concerning children's
risks. Second, EPA does not require rule writers to thoroughly
document consideration of children in the agency's Rule and Policy
Information Development System (RAPIDS). EPA uses RAPIDS to track,
approve, and report on agency actions, including rulemakings. RAPIDS
allows EPA staff to document milestones in all phases of the
rulemaking process and archives key information, according to EPA.
However, RAPIDS captures limited information about human health or
children's environmental health considerations. It does not, for
example, capture whether a risk assessment is conducted as part of a
rulemaking. Furthermore, in January 2008, EPA eliminated a check-box
in RAPIDS that indicated whether a rulemaking involved environmental
health risks or safety risks that may pose disproportionate risks to
children. EPA added three questions about human health impacts to
RAPIDS, but those do not directly address disproportionate risks to
children. In addition, the human health data maintained in RAPIDS can
be inaccurate or incomplete because they are gathered early in the
rulemaking process and are rarely updated later in the process,
according to officials with whom we spoke. Finally, EPA does not
require rule writers to document consideration of children in
preambles of all published regulations, even though the Office of
Children's Health has urged EPA to require this.
EPA has taken steps to comply with the Executive Order's requirements
by, for example, publishing updated guidance to assist rule writers in
addressing children's risks in October 2006.[Footnote 37] The guidance
identifies key steps where rule writers should consider children in
the rulemaking process. For example, it advises workgroups that are
developing a regulation to describe proposed children's analyses in
their plans for data collection and analyses. The guidance also
advises rule writers to work with risk assessors early in the
rulemaking process to begin accumulating information about potential
children's risks. EPA has also developed a variety of guidance to
assist risk assessors in addressing risks to children, including 2005
guidance on assessing susceptibility from early life exposure to
carcinogens and 2008 guidance on assessing children's exposures to
environmental contaminants.[Footnote 38] EPA's first use of the cancer
guidance is its draft risk assessment for ethylene oxide--used to make
antifreeze, detergents, and polyester, and as a fumigant pesticide.
The draft assessment also includes EPA's first use--apart from
pesticide tolerances--of an additional safety factor for children and
proposes reducing the agency's 1985 standard of 3.6 parts per billion
for protecting against cancer risks to a much stricter limit of 0.6
parts per trillion.
According to staff from the Office of Children's Health, some EPA
staff are more aware than others of the need to consider children's
risks in rulemakings, in part because of the guidance they helped
develop. However, officials from the office told us that EPA has not
taken additional steps that would help institutionalize the use of the
applicable guidance. For example, EPA does not provide rule writers
with specific training on the guidance, according to officials. Rule
writers are required to attend a 3-day comprehensive training course
organized by EPA's Office of Policy, Economics, and Innovation, but
the course includes only a limited discussion of children's
environmental health because of competing demands. The Office of
Children's Health has instructed part of this course in the past, but
has not done so since 2006, according to office officials. In
addition, EPA has been slow to implement at least one guidance
document aimed at improving consideration of children in risk
assessments and economic analyses used to support rulemakings.
Specifically, in 2005 EPA issued guidance on selecting age groups for
monitoring and assessing childhood exposures to environmental
contaminants, but did not use the guidance in developing a risk
assessment until 2008.[Footnote 39] In another example, EPA's Office
of Policy, Economics, and Innovation issued guidance on assessing the
economic value of children's health benefits in October 2003, but the
Director of the Office of Children's Health told us the agency could
expand efforts to ensure that children are adequately considered in
economic assessments.[Footnote 40]
Although the Office of Children's Health can advocate that EPA address
disproportionate risks to children, we found that it has had a limited
role in rulemakings for a number of reasons. Because the office is not
a regulatory office like the Office of Air and Radiation, it does not
initiate rulemakings. Instead, the Office of Children's Health
participates on regulatory workgroups as staff resources permit.
Regulatory workgroups, which develop regulations, consist of members
from EPA's program offices and regional offices. EPA does not maintain
reliable information on the number of regulatory workgroups that have
included a representative from the Office of Children's Health, but
the office has participated on only a small number of regulatory
workgroups because of its limited resources, according to office
officials. They told us that from 2007 through 2008, the office
participated in final review for seven rulemakings, including reviews
of the NAAQS for ozone and lead.[Footnote 41] The Office of Children's
Health's limited resources may also have limited its participation on
the regulatory workgroup responsible for EPA's most recently completed
review of National Ambient Air Quality Standards for Particulate
Matter, published in October 2006. The office's representative on the
workgroup was not designated an official workgroup member who would
receive all chapters of the draft regulation, according to internal
documents that we reviewed. Furthermore, the office did not send a
representative to two key meetings, according to the workgroup
chairman. The office's current director told us that he views this as
a critical part of the office's work, and he will increase its
participation in EPA rulemakings.
EPA's rulemaking for particulate matter standards provides an
illustration of a rulemaking in which EPA documented its efforts to
comply with the Executive Order. For its air quality standards for
particulate matter, EPA addressed children's risks throughout the
rulemaking process, according to documents and EPA officials who
served on the regulatory workgroup. For example, it considered
children in quantitative and qualitative risk assessments and its
analysis of the scientific bases for alternative policy options.
[Footnote 42] In addition, EPA addressed children's risks in internal
documents, including briefing slides and documents for the rulemaking
that we reviewed. The Administrator eventually selected standards that
were less stringent than those recommended by the Office of Children's
Health and by EPA advisory committees. EPA documented its analyses in
the notices of the proposed and final regulations as well as in the
public docket, and the United States Court of Appeals for the District
of Columbia used these analyses, in part, to support its February 2009
decision to remand a key standard to EPA for review.[Footnote 43] The
court stated that EPA had failed to explain why it believed the
standard would provide an adequate margin of safety against illness in
children and other vulnerable subpopulations, as required by the Clean
Air Act.[Footnote 44] In its opinion, the court cited analyses by EPA
staff and determined that the Administrator had apparently too hastily
discounted studies of the effect of particulate matter on children.
Regulatory Requirements in the Executive Order Have Had Minimal Impact
on EPA Rulemakings:
The Executive Order requires EPA to evaluate the environmental health
or safety effects on children of each of the covered regulations.
However, the requirements had a minimal impact on rulemakings
conducted between 1998 and 2008[Footnote 45] for three reasons: (1)
the order applied to a narrow subset of rulemakings, (2) EPA was
already considering risks to children in the rulemaking process when
the order took effect, and (3) EPA does not interpret the order as
requiring any particular analyses on children's environmental health.
Furthermore, we reviewed the preambles of all proposed and final
regulations that EPA determined to be subject to the requirements, and
found that EPA varied in how explicitly it addressed the requirements
of the Executive Order therein.
First, the Executive Order only applies to a narrow subset of
regulations. We determined that just 17 EPA rulemakings were subject
to the order since it took effect. On average, EPA applied the order
to fewer than 2 of the approximately 450 rulemakings it completed each
year, even though some of those rulemakings were especially important
to children's health. One reason for the low number is that the order
extends only to situations in which analysis of the regulation's
effects on children has the potential to influence the regulation,
according to EPA's interpretation. Thus, EPA does not apply the order
to regulations that are based solely on technology performance, since
health-based information cannot influence such regulations. EPA
guidance states that the agency may be statutorily precluded from
considering health or safety risks when setting certain technology-
based standards. For example, under the Clean Air Act, EPA is required
to base certain initial performance standards on emissions levels that
are already being achieved by better-controlled and lower-emitting
sources in an industry, and not on human health outcomes. On this
basis, EPA determined that a proposed technology-based regulation on
mercury emissions from cement plants, issued in May 2009, was not
subject to the order, even though the regulation addressed an
environmental health risk that disproportionately affects children's
health.[Footnote 46]
Another reason the Executive Order only applies to a narrow subset of
regulations is that it applies only to rulemakings that are considered
economically significant under a separate executive order--Executive
Order 12866. As a result, individual EPA rulemakings only trigger the
Executive Order's analytical and procedural requirements if they have
an annual impact of $100 million or more, or will have certain
material adverse economic effects, a criterion that excludes most of
EPA's regulations. This is consistent with our 2009 report that stated
most major rulemakings triggered the analytical requirements of the
Regulatory Flexibility Act, Executive Order 12866, and the Paperwork
Reduction Act but few other commonly applicable rulemaking
requirements such as Executive Order 13045.[Footnote 47] Between 1998
and 2008, EPA issued only 54 final regulations that were determined to
be economically significant.[Footnote 48] According to a 2008 study--
authored by staff from the Office of Children's Health--at least 65
regulations involving disproportionate risks to children were not
subject to the Executive Order because they were not considered
economically significant.[Footnote 49] Fifty of those 65 regulations
concerned the amount of pesticides that may remain in or on food.
However, for those 50 rulemakings and the others that were not subject
to the Executive Order, EPA must still comply with provisions in
environmental statutes, such as the Food Quality Protection Act of
1996,[Footnote 50] that expressly concern children (see table 1).
Although the scope of the Executive Order's regulatory requirement is
limited, EPA did apply it to some regulations that the agency
estimated to significantly impact children's environmental health. For
example, it applied to three rulemakings that established the NAAQS.
According to the Director of EPA's Office of Children's Health, those
standards are among the most important decisions EPA made regarding
children's health.
A second reason that the Executive Order had a minimal impact on
rulemakings is because EPA was already considering risks to children
in its rulemaking process when the order took effect. For example,
EPA's 1995 Policy on Evaluating Health Risks to Children directs
agency staff to consider the risks to infants and children
consistently and explicitly in all risk assessments, including those
that support rulemakings. Another reason is that federal agencies were
already required to perform some of the analyses that the order calls
for. For example, both the children's executive order and Executive
Order 12866, issued in 1993, require agencies to explain why a planned
regulation is preferable to other "potentially effective and
reasonably feasible alternatives" considered by the agency.[Footnote
51] According to EPA officials, the agency does not provide additional
documents to the Office of Information and Regulatory Affairs if a
proposed regulation is subject to both the children's executive order
and Executive Order 12866, rather than Executive Order 12866 alone.
Nor has the Office of Information and Regulatory Affairs requested
additional information about children's environmental health in these
situations, according to officials from that office.
Third, EPA does not require any particular analyses to comply with the
Executive Order's mandate that agencies evaluate the effects of any
planned regulation on children. EPA has guidance to assist staff in
complying with this requirement, but it gives staff considerable
discretion. Furthermore, past guidance has been inconsistent. For
example, the agency's 2003 Children's Health Valuation Handbook notes
that one way to address the requirement is to analyze the costs,
benefits, or other economic impacts of a policy on a specific
subpopulation. EPA's 2000 Guidelines for Preparing Economic Analyses,
however, states that the Executive Order primarily addresses risks
rather than economic analyses.
Furthermore, we found that EPA varied in how explicitly it addressed
the requirements of the Executive Order in publication of regulations.
Every EPA Federal Register notice of a regulation subject to the order
has a section in the preamble specifically addressing the order. We
reviewed this section of all relevant notices from 1998 through 2008,
and EPA did not always provide information on how it complied with the
Executive Order or on what it found in conducting the required
analyses.[Footnote 52] We found that EPA has not consistently
documented in this section how it considered children's environmental
health risks. Specifically, we found that EPA either quantified the
effects on children or explained why it did not, or could not do so,
for only 4 of the 17 of the rulemakings. We also found variation in
the extent to which EPA provided information in the Federal Register
notice about how the agency addressed the Executive Order's
requirement to evaluate the environmental health or safety effects on
children, with some notices providing minimal information. For
example, the notices of the final regulations establishing the NAAQS
for lead, ozone, and particulate matter merely stated that the
standards may be especially important for children because the
contaminants in question may disproportionately affect children's
health. While EPA had conducted analyses of children's health in
developing those regulations, this section of the notice did not
provide the public with a summary of EPA's analyses, making it
difficult for the public to understand the basis upon which EPA made
its decision. Finally, EPA did not include, in the section on the
Executive Order, any explanation of why a planned regulation is
preferable to other "potentially effective and reasonably feasible
alternatives" in 9 of 17 rulemakings. Appendix IV provides details of
our analysis of EPA Federal Register notices for the 17 rulemakings
that we determined to be subject to the Executive Order's regulatory
requirements.
In some cases, EPA's preamble discussion of its compliance with the
Executive Order went beyond identifying its requirements, while at
least one other agency responsible for rules potentially concerning
risks to children does not routinely address the order in its Federal
Register notices of regulations. For example, some EPA notices
included information on data gaps that limited EPA's ability to more
fully address the order's requirements. In the notice for the National
Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water
Treatment rule, EPA stated that data were not adequate to conduct a
quantitative risk assessment specifically for children and that EPA
assumed the same risk for children as for the population as a whole
when evaluating regulatory alternatives. In contrast, the Food and
Drug Administration does not appear to have discussed the Executive
Order in its notices. This includes its notice on the final
regulation--Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation--issued in July 2009, even
though the regulation was economically significant and concerned a
risk that disproportionately affects children.
In Recent Years, EPA Has Not Fully Utilized Its Office of Children's
Health and Other Child-Focused Resources:
EPA's Office of Children's Health has recently had inconsistent
leadership and direction, and the agency has not fully utilized other
child-focused resources, such as its regional children's health
coordinators and its Advisory Committee.
EPA's Children's Health Protection Office Has Lacked Committed and
Consistent Leadership:
EPA's Office of Children's Health experienced multiple changes in
leadership over the last several years, impairing its ability to
fulfill its priorities and commitments. From 2002 to 2008, the office
had four acting directors and no permanent director.[Footnote 53] EPA
staff told us the Office of Children's Health had difficulty
maintaining focus because of the varied priorities and initiatives of
each director. For example, in 2007, the acting director tasked office
staff to form workgroups and collaborate with senior program office
staff across the agency in response to a set of recommendations from
the Advisory Committee. The committee had recommended expanding
research and committing additional EPA infrastructure to children's
health, among other things, and the Administrator and acting director
had committed to addressing the recommendations. The office's
subsequent acting director eliminated the workgroups, and the office
has yet to meaningfully address the Advisory Committee's
recommendations. The committee has previously noted leadership
challenges in the office, writing in a December 2002 memo to the
Administrator that the office could not continue to play a key role
within EPA and across the nation without permanent leadership. In May
2004, EPA's Inspector General reported that the lack of a permanent
director may have a negative impact on the longevity and importance of
the children's environmental health program within EPA.[Footnote 54]
We have previously reported that career government officials in
leadership positions can help provide the long-term focus needed to
institutionalize reforms that political appointees' often more limited
tenure does not permit.[Footnote 55] Committed and consistent
leadership is particularly important to the Office of Children's
Health. Its mission is broad and far reaching, requiring continuous
integration and communication with other EPA offices. For example, the
office participates frequently in agencywide workgroups such as the
Science Policy Council and the Risk Assessment Forum. The office also
contributes expertise on science issues within EPA. For instance, it
works with agency scientists on how to consider age-specific
biological differences when conducting exposure and quantitative risk
assessments. Leadership is also important because the office is
supported by few resources and has a small number of staff, and
because responsibility for implementing agencywide children's health
priorities ultimately resides with EPA's program and regional offices.
These conditions necessitate a proactive leader who can secure
commitments from other parts of EPA to develop children-focused cross-
agency activities.
We also found that the effectiveness of the Office of Children's
Health has declined in the absence of direct and meaningful support
from EPA's Administrator. In our report, we wrote that sustained top
leadership commitment is the single most important element in
successfully implementing organizational change and that this
commitment is most prominently shown through personal involvement of
top leaders in developing and directing reform efforts.[Footnote 56]
In 1997, EPA's then-Administrator provided the first director of the
Office of Children's Health with the necessary support to pursue
initiatives by, for example, endorsing the director's decision to
review the extent to which children's environmental health was
considered in EPA's research budget and regulatory and science
policies. EPA staff told us that the Administrator also endorsed the
office's work with the Office of Research and Development to
incorporate children's health concerns into the agency's exposure
assessment guidelines, cancer guidelines, and its database on chemical
risks. In carrying out these initiatives, the former director had
frequent contact with the Administrator, and was invited to all
Administrator staff meetings, usually attending two each week. At
these meetings, the director had the opportunity to speak directly
with the Administrator's chief of staff and other EPA political
appointees on children's health issues. Between 2001 and 2003, EPA's
subsequent Administrator maintained a similar level of support for the
director of the Office of Children's Health. For example, the
Administrator gave the director significant responsibility for
representing EPA at international children's health conferences.
According to three former directors of the office, from 2003 until the
2009 installation of the new permanent director of the Office of
Children's Health, the office directors have not been given high-
profile responsibility for representing the agency. Furthermore, they
have not had the same level of access to the Administrator, having no
longer been invited to the Administrator's staff meetings. The current
director recently told us that, while he does not attend the
Administrator's regular senior-level meetings (i.e., with the
assistant and regional administrators), he believes he has had the
level of access to the Administrator that he needs.
EPA's Regions Have Widely Differing Staff Resources for Children's
Health and Lack Leadership from Headquarters:
EPA's 10 regional offices have widely differing staff resources
dedicated to children's environmental health, because the regional
administrators make that determination. As shown in figure 3, each
region has a designated children's environmental health coordinator,
but not every region has a full-time coordinator. Four regions have
one-fifth of a staff position or less dedicated to children's health
work.[Footnote 57] Moreover, Region 6 and Region 9--together covering
the states along the U.S. southern border--have one-hundredths of a
staff position for children's environmental health. EPA's regional
children's environmental health coordinators told us they believe they
are often understaffed, and even the full-time coordinators are
increasingly being asked to perform additional work not related
specifically to children's health. As a result, they are not able to
fully dedicate themselves to children's health.
Figure 3: EPA Regional Children's Environmental Health Coordinator
Staffing Levels by Region, in FTEs:
[Refer to PDF for image: United States map]
The map depicts the boundaries of the regions, as well as the
following FTEs by region:
Region 1: 0.2.
Region 2: 1.0.
Region 3: 1.0.
Region 4: 1.0.
Region 5: 1.0.
Region 6: 0.0.
Region 7: 0.1.
Region 8: 1.0.
Region 9: 0.01.
Region 10: 0.5.
Source: EPA.
Note: Region 2 includes Puerto Rico and the U.S. Virgin Islands,
Region 9 includes Hawaii, and Region 10 includes Alaska.
[End of figure]
In addition, EPA's regional children's health coordinators told us
their roles are neither set by the Office of Children's Health nor set
to directly support agencywide, children-specific goals or strategies.
Although the office facilitates information sharing among regional
coordinators, primarily through monthly conference calls and an annual
meeting, the 10 regional administrators determine the
responsibilities, resources, and organizational placement of the
children's environmental health coordinators within their respective
region. For example, one EPA deputy regional administrator identified,
as priority areas, three contaminants that pose risks to children--
diesel, lead, and radon. The children's environmental health
coordinator in that region subsequently sought resources from the
program office to determine how to address these priorities and
collaborate with ongoing projects in the region. In another region,
priority setting was done from the "bottom up," driven largely by the
availability of external (non-EPA) funding from sources such as
nonprofit organizations. In addition, the Office of the Administrator
has a lead coordinator who serves as a liaison between the regional
offices and the eight suboffices within the Office of the
Administrator (including the Office of Children's Health), but the
lead also has a limited role determining EPA's children's health
activities, with approximately one-eighth of their time working with
the Office of Children's Health.
According to Office of Children's Health officials, most EPA regions
do not have a dedicated budget to support the children's health
coordinators. Often, coordinators must take the initiative to obtain
assistance, or get logistical support, from other staff from the EPA
branch or division in which they are located. As shown in table 3, the
organizational placement of the children's coordinators also varies
widely across the regions. That regional structure has led to
differing priorities across regions, which may be appropriate in some
circumstances when coordinators need to respond to unique regional
children's health challenges, but does not provide a consistent
organizational mechanism that integrates the Office of Children's
Health or institutionalizes the Administrator's top children's health
priorities across the regions.
Table 3: Placement of EPA's Regional Children's Health Coordinators
within the Offices of the Regional Administrator:
EPA region: 1;
Organizational placement: Office of Public Affairs.
EPA region: 2;
Organizational placement: Office of Strategic Programs.
EPA region: 3;
Organizational placement: Environmental Assessment and Innovation
Division; Office of Environmental Innovation.
EPA region: 4;
Organizational placement: Air, Pesticides and Toxics Management
Division; Pesticides and Toxics Substances Branch; Children's Health,
Lead and Asbestos Section.
EPA region: 5;
Organizational placement: Land and Chemicals Division; Chemical
Management Branch.
EPA region: 6;
Organizational placement: Multimedia Planning and Permitting Division;
Toxics Branch.
EPA region: 7;
Organizational placement: Office of Public Affairs.
EPA region: 8;
Organizational placement: Office of Partnerships And Regulatory
Assistance; State Partnerships and Sustainable Practices Program.
EPA region: 9;
Organizational placement: Office of Public Affairs.
EPA region: 10;
Organizational placement: Office of Ecosystems, Tribal, and Public
Affairs; Ecosystems, Community Health, and Environmental Justice
Branch.
Source: GAO based on EPA information.
[End of table]
According to EPA officials, a key factor in ensuring effective
regional children's health coordinators is strong leadership and
direction from the EPA Administrator and other top EPA officials.
While regional administrators and other managers were involved in
agencywide strategy and priority setting exercises related to
children's health issues starting in early 2001, such efforts have not
taken place since 2003. At present, there is no formal, agencywide
effort in which EPA's regional or deputy administrators involve
themselves in children's health issues. Instead, EPA staff told us
that many EPA regions react to children's health crises, rather than
proactively supporting programs to prevent children's health problems
before they arise. Furthermore, regional administrators may or may not
take direction from the Office of Children's Health, and several EPA
officials stated that the office has rarely communicated its
priorities to the EPA regional administrators or deputy regional
administrators.[Footnote 58] The office recently told us that the new
director has discussed his five-point approach in a call with the
deputy regional administrators and visited four regional offices to
discuss children's health with regional staff and managers.
EPA Has Made Little Use of Its Children's Health Protection Advisory
Committee:
In September 2008, we testified that EPA had not proactively used its
Children's Health Protection Advisory Committee to maintain a focus on
protecting children's environmental health.[Footnote 59] As we said
earlier, the Advisory Committee was established to provide advice,
consultation, and recommendations to EPA in the areas of research,
community outreach, and the development of regulations, guidance, and
policies. EPA rarely sought out the Advisory Committee's advice in
those areas, despite convening the committee 33 times between 1998 and
2008 for presentations and discussions with EPA and non-EPA officials.
We identified only four instances where EPA specifically asked for the
committee's advice on research, three instances on outreach, four
instances on regulations, and two instances on guidance. We did not
identify any instances where EPA sought out the committee's advice on
policies, including the Policy on Evaluating Health Risks to Children,
which has not been updated since it was established in 1995.
Nonetheless, the members of the Advisory Committee drafted and
approved 74 letters to the Administrator between 1998 and 2008, to
which EPA responded 53 times (about 73 percent). Those letters
contained a range of information, advice, and recommendations. The
Advisory Committee's letters offered EPA hundreds of recommendations
about a variety of topics related to reducing environmental health
risks to children. We identified 607 recommendations during our review
of the Advisory Committee's letters. A small number of letters
contained recommendations relating to multiple children's
environmental health issues, such as a May 2008 letter with
recommendations about mercury regulation, farm worker protection
standards, organophosphate pesticides, and air quality. However, most
letters contained recommendations on a single issue. The number of
recommendations varied from year to year, ranging from 120 in 2000 to
20 in 2001. We placed the 607 recommendations into 10 categories that
demonstrate the breadth and depth of the Advisory Committee's
concerns. Figure 4 shows the number of recommendations in each
category. Some recommendations were placed into multiple categories
when, for example, a recommendation was related to "research" and
"policy and procedures."[Footnote 60] The largest category of
recommendations concerned how EPA conducts, prioritizes, and utilizes
research on children's environmental health. The next largest
categories involved the agency's policies and priorities and the
development and use of guidance documents.
Figure 4: Number of Children's Health Protection Advisory Committee
Recommendations by Category:
[Refer to PDF for image: vertical bar graph]
Category: Research;
Number of recommendations: 122.
Category: EPA policies and priorities;
Number of recommendations: 97.
Category: Guidance development and usage;
Number of recommendations: 97.
Category: External partnership and inter-agency coordination;
Number of recommendations: 87.
Category: Risk assessment;
Number of recommendations: 83.
Category: Regulations and standards;
Number of recommendations: 81.
Category: Education and public awareness;
Number of recommendations: 69.
Category: EPA organization and processes;
Number of recommendations: 64.
Category: Tracking and indicators;
Number of recommendations: 59.
Category: Budget and resources;
Number of recommendations: 36.
Source: GAO analysis of Advisory Committee letters.
Note: Because recommendations may appear in multiple categories, the
number of recommendations shown in the figure exceeds the total number
of recommendations.
[End of figure]
In our September 2008 testimony, we also stated that EPA had not
substantially addressed key Advisory Committee recommendations. For
example, EPA had not specifically acknowledged 11 of the Advisory
Committee's 23 recommendations concerning proposed revisions to the
NAAQS for particulate matter, ozone, and lead. EPA did provide the
Advisory Committee with official response letters to six of its seven
NAAQS-related letters, but generally did not acknowledge or was
noncommittal to the Advisory Committee's recommendations. Instead, it
provided a generic statement about considering the recommendations
with all other public comments. We also testified that EPA had not
fulfilled its commitment to address key recommendations submitted to
EPA by the Advisory Committee on the 10th anniversary of the Executive
Order. The Advisory Committee's April 10, 2007, letter provided
recommendations in seven areas for renewing EPA's vision on children's
environmental health and its commitment to the principles outlined in
the order. EPA's June 13, 2007, response letter directed the Office of
Children's Health to work collaboratively with program offices across
the agency and committed the agency to working with the Advisory
Committee to review these recommendations. However, while the office
established workgroups within its Children's Health Advisory
Management Partners group to address each of the seven areas outlined
by the Advisory Committee, a new acting director stopped the process
in late 2007.
In our September 2008 testimony, we recommended that the Administrator
examine ways to more proactively use the Advisory Committee to
reinvigorate the agency's focus on protecting children's health. Since
that time, EPA's Administrator and the Director of EPA's Office of
Children's Health have met with the Advisory Committee in March and
July 2009, respectively. In his remarks to the Advisory Committee, the
Director expressed his commitment to more proactively use the Advisory
Committee to support EPA's efforts to protect children's health.
Specifically, he said that EPA could more effectively use the Advisory
Committee for advice in developing regulations, and he asked for input
on how to engage the Advisory Committee early and often in
rulemakings. He also said that the committee could provide leadership
in the area of science policy at EPA. He told the committee that it
could advise EPA on developing policies for conducting research and
making decisions in instances where EPA lacks conclusive information
about children's vulnerabilities. For example, the Director recently
asked the committee to provide EPA with advice on its draft school
siting guidelines.
Opportunities Exist for EPA to Lead and Coordinate National Efforts to
Protect Children from Environmental Threats:
The Executive Order provides EPA with opportunities for leadership and
coordination across the federal government. Key provisions of the
Executive Order, specifically an interagency task force that reports
to the President on federal research priorities--were allowed to lapse
in 2005. There are other federal opportunities to set national goals
and indicators related to children's environmental health, such as the
Interagency Forum on Child and Family Statistics and Healthy People
2020.
Task Force Provided High-level Opportunities for Strategy Development
and Interagency Coordination until It Expired in 2005:
The President's Task Force on Children's Environmental Health Risks
and Safety Risks was authorized by the Executive Order in April 1997
for a period of 4 years to provide high-level leadership and
interagency coordination on children's environmental health. It
comprised nine cabinet officials and seven White House office
directors and was co-chaired by the Administrator of EPA and the
Secretary of the Department of Health and Human Services. The Task
Force convened five times for meetings in October 1997, April 1998,
January 1999, September 1999, and October 2001. As part of National
Children's Health Month in October 2001, the President extended the
Task Force for 2 years. According to EPA officials, the Administrator
urged the President to continue the Task Force; in April 2003, the
President extended it for a final 2 years. However, the final order
eliminated the provision for reassessing the need for continuance of
the Task Force, which was not convened after the October 2001 meeting.
According to EPA officials involved on the steering committee, the
agency was not able to convene the Task Force thereafter, for reasons
related to new priorities following the September 11, 2001, terrorist
attacks. Nonetheless, a senior career-level staff steering committee
continued to meet until 2005 to coordinate and implement the
strategies that the Task Force developed to address the threats to
children's health.
The Task Force contributed to eight areas which related to children's
health, including the establishment of the National Children's Study,
the largest long-term study of environmental influences on children's
health and development. The study was proposed and developed through
the cooperation of four agencies, including EPA, to examine the
effects of environmental influences on the health and development of
more than 100,000 children across the nation, following them from
before birth until age 21. It was initiated as part of the Children's
Health Act of 2000.
The Task Force also identified four major environmental and safety
threats to children--asthma, developmental disabilities (including
lead poisoning), cancer, and unintentional injuries--and created
national strategies for each of them. In its strategy documents, the
Task Force recognized that an integrated solution was needed across
the federal government to address the complex interaction between a
child's biology, behavior, and the physical, chemical, biological, and
social environment. According to the children's health experts with
whom we spoke--including EPA's first senior advisor for children's
health and the first director of the office--the Task Force provided
critical leadership on several important initiatives such as the
National Children's Study and the Healthy School Environments
Assessment Tool (HealthySEAT). These national programs focus heavily
on the environmental influences on children's health, with the
National Children's Study examining the role of environmental factors
on health and disease and Healthy SEAT offering school districts a
self-assessment tool for identifying and evaluating environmental,
safety, and health hazards.
In addition, the departments and agencies that made up the Task Force
partnered to prepare a fiscal year 2001 interagency budget initiative
to fund the Task Force's initiatives in the four priority areas. The
Secretary of Health and Human Services and the Administrator of EPA
submitted the request to OMB with the recommendation that it be
included as part of the President's budget request that year. EPA
officials told us that OMB's involvement helped ensure that adequate
funds were available to these agencies to address children's health.
This interagency budgeting effort did not continue past the last
meeting of the Task Force in 2001.
Since the Task Force's expiration, EPA and the Department of Health
and Human Services no longer have a high-level infrastructure or
mandate to coordinate federal strategies for children's environmental
health and safety. According to the EPA staff and children's health
experts with whom we spoke, had the Task Force continued, it could
have helped the federal government respond to the health and safety
concerns that prompted the 2007 recall of 45 million toys and
children's products. Furthermore, since the Task Force provision of
the Executive Order expired in 2005, the Task Force's reports are no
longer generated. Those reports collected and detailed the interagency
research, data, and other information "necessary to enhance the
country's ability to understand, analyze, and respond to environmental
health risks to children."
The Task Force was also charged with preparing reports on research,
data, and other information that would enhance the federal
government's ability to understand, analyze, and respond to
environmental health risks to children. In the 2003 order to extend
the Task Force, the President also directed that each report detail
the accomplishments of the Task Force from the date of the preceding
report. Through the biennial reporting process, each agency on the
Task Force identified and described key data needs related to
environmental health risks to children that had arisen in the course
of the agency's programs and activities. The reports were made
available to the public and intended for use by the Office of Science
and Technology Policy and the National Science and Technology Council
to establish national research priorities.
EPA Has Had Varied Involvement in Federal Interagency Forum on Child
and Family and Children Statistics:
The Executive Order also formally established the Interagency Forum on
Child and Family Statistics, made up of representatives from federal
statistics and research agencies and convened by the Director of OMB.
[Footnote 61] The order required the forum to publish an annual report
on the most important indicators of the well-being of the country's
children. As a result, the forum has published America's Children: Key
National Indicators of Well-Being each year since 1997. The 2003
amendments to the Executive Order required the forum to begin
publishing the report biennially. Accordingly, the forum issued a
brief report in 2004 to highlight selected indicators, and it
publishes the full report on alternate years. The Interagency Forum
also updates all indicators and background data each year on its Web
site.[Footnote 62]
According to the forum's 2009 report:
One important measure of children's environmental health is the
percentage of children living in areas in which air pollution levels
are higher than the allowable levels of the Primary National Ambient
Air Quality Standards. These standards, established by the U.S.
Environmental Protection Agency under the Clean Air Act, are designed
to protect public health, including the health of susceptible
populations such as children and individuals with asthma. Ozone,
particulate matter, sulfur dioxide, and nitrogen dioxide are air
pollutants associated with increased asthma episodes and other
respiratory illnesses. Lead can affect the development of the central
nervous system in young children, and exposure to carbon monoxide can
reduce the capacity of blood to carry oxygen.
Table 4 shows the key national indicators for physical environment and
safety from the 2009 report.
Table 4: Key Physical Environment and Safety Indicators of Children's
Well-Being, 2009:
Indicator: Outdoor and indoor air quality;
Measure: Children ages 0-17 living in counties in which levels of one
or more air pollutants were above allowable levels;
Previous value (year): 66% (2006);
Most recent value (year): 66% (2007);
Change between years: NS.
Indicator: Drinking water quality;
Measure: Children served by community water systems that did not meet
all applicable health-based drinking water standards;
Previous value (year): 9% (2006);
Most recent value (year): 8; (2007);
Change between years: NS.
Indicator: Lead in the blood of children;
Measure: Children ages 1-5 with blood lead level greater than or equal
to 10 mg/dL;
Previous value (year): 2% (1999-2002);
Most recent value (year): [A] (2003-2006);
Change between years: NS.
Indicator: Housing problems;
Measure: Households with children ages 0-17 reporting shelter cost
burden, crowding, and/or physically inadequate housing;
Previous value (year): 40% (2005);
Most recent value (year): 43% (2007);
Change between years: NS.
Indicator: Youth victims of serious violent crimes;
Measure: Serious violent crime victimization of youth ages 12-17;
Previous value (year): 14 per 1,000 (2005);
Most recent value (year): 10 per 1,000 (2006);
Change between years: NS.
Indicator: Child injury and mortality;
Measure: Injury deaths of children, ages 1-4;
Previous value (year): 13 per 100,000 (2005);
Most recent value (year): 12 per 100,000 (2006);
Change between years: NS.
Indicator: Child injury and mortality;
Measure: Injury deaths of children, ages 5-14;
Previous value (year): 8 per 100,000 (2005);
Most recent value (year): 7 per 100,000 (2006);
Change between years: Statistically significant decrease.
Indicator: Child injury and mortality;
Measure: Injury deaths of adolescents, ages 15-19;
Previous value (year): 50 per 100,000 (2005);
Most recent value (year): 50 per 100,000 (2006);
Change between years: NS.
Source: Forum on Child and Family Statistics, America's Children: Key
National Indicators of Well-Being, 2009.
Notes:
[A] Percentage is not shown because sample is too small to provide a
statistically reliable estimate.
NS: No statistically significant change.
[End of table]
The forum's reports provide substantial detail about each indicator,
including its relationship to children's health, and identify
important areas where indicators are needed. For example, the 2009
report identified the need for a broader set of indicators on (1) body
burden measurements (i.e., levels of contaminants in blood and urine)
to characterize children's exposures, and (2) environmental quality to
assess indoor air contaminants other than environmental tobacco smoke
(e.g., pesticides) in homes, schools, and day care settings and for
cumulative exposures to multiple environmental contaminants that
children encounter daily.
Our analysis of EPA's involvement in the forum showed that the agency
has not been consistently involved over the years. EPA had nearly no
involvement in the first three reports--1997, 1998, and 1999--and, not
surprisingly, those reports contained no indicators related to
children's environmental health. Beginning with the 2000 report, the
Director of the Office of Children's Health helped lead the
establishment of an indicator on air pollution (i.e., the NAAQS). That
report identified the need for indicators to describe children's
potential exposure to contaminants in drinking water and food.
Subsequent reports began including an expanded set of indicators,
including one for drinking water. Beginning in 2003, EPA's newly
created Office of Environmental Information led EPA's involvement. In
2008, EPA's Office of Children's Health was again made the lead office
for the agency. The official contact for the office is its Director of
the Child and Aging Health Protection Division, who recently told us
that the office again is participating and coordinating with other
offices such as the EPA's Office of Policy, Economics, and Innovation.
Additional Federal Efforts to Address Children's Environmental Health
Risks:
In addition to the provisions of the Executive Order, there are other
federal opportunities to address children's environmental health,
including Healthy People 2010 and Healthy People 2020 and the
international commitments to environmental health through the G8
(Group of Eight) countries. Healthy People is led by the Department of
Health and Human Services and is composed of 28 focus areas with a
total of 467 objectives and targets, including 17 on environmental
quality. Within each area, Healthy People selected a few leading
indicators. The Healthy People 2010 leading indicators for
environmental quality are:
* reduce the proportion of children, adolescents, and adults that are
exposed to ozone above the EPA standard from 43 percent (in 1997) to 0
percent (by the year 2010), and:
* reduce the proportion of nonsmokers exposed to environmental tobacco
smoke (i.e., secondhand smoke) from 65 percent (in 1988-1994) to 45
percent (in 2010).
According to Healthy People 2010, these indicators were selected
because poor air quality contributes to respiratory illness,
cardiovascular disease, and cancer. For example, asthma can be
triggered or worsened by exposure to ozone, and while the overall
death rate from asthma increased 57 percent from 1980 to 1993, for
children it increased 67 percent. Healthy People 2010 is national in
scope and includes identifying health indicators, collecting data, and
reporting on progress toward meeting a range of health goals. In fact,
the data sources for tracking most environmental indicators come from
EPA.
EPA's environmental regulations and standards are key to achieving
national environmental health objectives. EPA was not a lead federal
agency in efforts to develop the Healthy People 2010 goals and
indicators for environmental quality or the Federal Interagency
Workgroup for Healthy People 2020. The agencies involved in Healthy
People 2010 and 2020 are the Agency for Toxic Substances and Disease
Registry, CDC, and the National Institutes of Health--each within the
Department of Health and Human Services, the department that formerly
co-chaired the Task Force with EPA.
With regard to international agreements, while the United States
reiterated its commitment to protect children from environmental
threats at the most recent meeting of the G8 environmental ministers,
EPA has not undertaken an evaluation of its progress since 2002 or
considered opportunities for a broader leadership role. The
environmental ministers of the G8 countries declared that children's
environmental health was a shared priority among the eight countries
at their meeting in Miami, Florida, in May 1997.[Footnote 63] They
developed the Declaration of the Environmental Leaders of the Eight on
Children's Environmental Health (Miami Declaration) that provided a
framework for domestic, bilateral, and international actions by member
nations to improve protection of children's health from seven
environmental threats. In 2002, the Government of Canada published a
status report on the implementation of the Miami Declaration. Table 5
lists the seven issues and key commitments, along with a brief
progress summary from Canada's report. Notably, the status update for
U.S. commitments on lead and air quality refer to two of the national
strategies developed by the now-defunct President's Task Force.
Table 5: Summary of Commitments and U.S. Implementation of the 1997
Miami Declaration, as of 2002:
Children's environmental health issue: Risk assessment and standard
setting;
Key commitment: "We pledge to establish national policies that take
into account the specific exposure pathways and dose-response
characteristics of children when conducting environmental risk
assessments and setting protective standards";
Status update: Implementation of the Food Quality Protection Act
requires an additional 10-fold margin of safety for threshold effects.
Children's environmental health issue: Lead;
Key commitment: "We call for further actions that will result in
reducing blood lead levels in children to below 10 micrograms per
deciliter. Where this blood lead level is exceeded, further action is
required";
Status update: Implementation of the federal Strategy to Eliminate
Childhood Lead Poisoning by 2010.
Children's environmental health issue: Microbiologically safe drinking
water;
Key commitment: "We agree to focus increased attention on drinking
water disinfection, source water protection and sanitation...";
Status update: There are new final rules for Cryptosporidium and
disinfection by-products.
Children's environmental health issue: Air quality;
Key commitment: "We undertake to reduce air pollution in our
respective countries. We agree to exchange information on indoor air
health threats and remedial measures";
Status update: Implementation of Asthma and the Environment: An Action
Plan to Protect Children.
Children's environmental health issue: Environmental tobacco smoke
(ETS);
Key commitment: "We agree to cooperate on education and public
awareness efforts aimed at reducing children's exposure to
environmental tobacco smoke";
Status update: A new national public information campaign focuses on
reducing at-risk children's exposure to ETS and other indoor and
outdoor asthma triggers.
Children's environmental health issue: Endocrine disrupting chemicals
(EDC);
Key commitment: "We encourage continuing efforts to compile an
international inventory of research activities, develop an
international science assessment…identify and prioritize research
needs and data gaps, and develop a mechanism for coordinating and
cooperating on filling research needs. We pledge to develop
cooperatively risk management or pollution prevention strategies, as
major sources and environmental fates of endocrine disrupting
chemicals are identified and will continue to inform the public as new
knowledge is gained";
Status update: The United States has a research program on EDCs and a
screening program.
Children's environmental health issue: Climate change;
Key commitment: The declaration does not contain any specific
commitments on this issue but recognized that "action must be taken to
confront the problem of global warming" given that "children and
future generations face serious threats to their health and welfare
from changes in the Earth's climate";
Status update: Global Change Research Program includes human health
assessments.
Source: Excerpts from Government of Canada, Status Report on the
Implementation of the 1997 Declaration of the Environment Leaders of
the Eight on Children's Environmental Health (2002).
[End of table]
EPA has not undertaken an evaluation of its progress toward the
country's international commitments for children's environmental
health. Nor has the United States taken a leadership role in updating
or reissuing specific new commitments since the 1997 declaration. At
the April 2009 meeting of the G8, the EPA Administrator cited the
declaration, highlighted subsequent U.S. activities, and provided
examples of other countries' actions--including Europe's new chemicals
policy and the World Health Organization's Children's Environment and
Health Action Plan.[Footnote 64] The Administrator closed her remarks
to the environmental ministers by stating,
We have learned much in the last 12 years about the ways that
environmental exposures uniquely affect children. With that increased
knowledge, our sense of urgency for further action on children has
also increased….The U.S. government, under this new administration,
will keep faith with the promise we've made to future generations. I
hope we can continue the work we started in 1997, renewing our
commitment to protect children from environmental threats where they
live, learn, work and play.
Conclusions:
Since the President signed Executive Order 13045 in 1997, every EPA
Administrator has stated that children's environmental health is a
priority at the agency. However, the momentum seen in the goals,
strategies, and accomplishments for children's health that resulted
from that initiative more than a decade ago has not been sustained
through succeeding EPA administrators. Instead, we have seen
diminished leadership, planning, and coordination at EPA and across
the federal government with regard to children's environmental health.
In the intervening years, research has only further substantiated the
importance that environmental exposures have during development--from
before birth, through early childhood and adolescence, and into
adulthood. The possibility that exposure to environmental contaminants
may have lifelong health consequences for an individual person--and
subsequent generations--is a paradigm shift in sophistication from the
idea that "children are not just little adults," an idea that was
groundbreaking in the early 1990s. In order to continue making
progress toward protecting children from environmental health threats,
we believe EPA needs to reinvigorate its leadership and focus on
children's environmental health in concrete and actionable ways.
Notwithstanding the actions that EPA can take on its own, leadership
from outside the agency will likely be needed for sustained progress
toward protecting children from current and emerging environmental
threats. As we stated in our testimony, the Children's Health
Protection Advisory Committee and the President's Task Force on
Children's Environmental Health Risks and Safety Risks have served as
two such entities. The Advisory Committee has provided strategic,
specific, and often unsolicited advice to EPA over the past decade. We
continue to believe that EPA could do more to fully utilize that body
of experts to inform EPA's developing regulations and generally
support the agency's efforts to protect children's health.[Footnote
65] Engaging the committee early and often in rulemakings and
providing leadership in the area of science policy and other areas
where EPA may lack conclusive information about children's
vulnerabilities would take advantage of the Advisory Committee's
expertise and reinvigorate its original purpose. The President's Task
Force that expired in 2005 provided high-level infrastructure to
coordinate federal strategies for children's environmental health and
safety problems such as asthma, as well as data needs. Furthermore,
the Task Force documented its accomplishments to the President in
reports that detailed its members' efforts to enhance the nation's
ability to understand, analyze, and respond to environmental health
risks to children. EPA staff and children's health experts told us the
Task Force could help the federal government respond to national
health and safety concerns, such as recalls of toys and other
children's products. Because the Task Force included nine cabinet
officials and seven White House office directors and was co-chaired by
the Administrator of EPA and the Secretary of Health and Human
Services, it provided the leadership and authority needed to address
children's environmental health issues of national scope. We see
opportunity for EPA to take a leadership role and identify, assess,
and address the environmental health challenges of the 21st century
such as low levels of toxic chemicals that may cause cancer and induce
reproductive or developmental changes in the nation's children.
Recommendations for Executive Action:
To help ensure that EPA assumes high-level leadership and develops
strategies and structures for coordinating efforts addressing
children's environmental health both within the agency and throughout
the federal government, we are making eight recommendations for
executive action.
To maximize opportunities to institutionalize children's health
throughout the agency, we recommend that the EPA Administrator take
the following actions:
* update and reissue a child-focused strategy, such as the 1996
National Agenda, to articulate current national environmental health
priorities and emerging issues;
* strengthen the data system that identifies and tracks development of
rulemakings and other actions to ensure they comply with the 1995
policy on evaluating health risks to children;
* re-evaluate the 1995 policy to ensure its consistency with new
scientific research demonstrating the risks childhood exposures can
have on risks for disease in later lifestages;
* ensure that the EPA's 2009-2013 strategic plan expressly articulates
children-specific goals, objectives and targets;
* re-evaluate the mission of the Office of Children's Health
Protection and its director to make the office an agencywide champion
for implementation of a reissued national children's environmental
health agenda, policy, and related goals in the next EPA strategic
plan;
* establish key children's environmental health staff within each
program office and regional office, with linkages to the Office of
Children's Health, to improve cross-agency implementation of revised
priorities and goals, and ensure coordination and communication among
EPA's program offices;
* use the Children's Health Protection Advisory Committee proactively
as a mechanism for providing advice on regulations, programs, plans,
or other issues; and:
* ensure participation, to the fullest extent possible, by the Office
of Children's Health or other key officials on the interagency
organizations identified in Executive Order 13045.
Matter for Congressional Consideration:
Because EPA alone cannot address the complexities of the nation's
challenges in addressing environmental health risks for children, we
encourage Congress to re-establish a government-wide task force on
children's environmental health risks, similar to the one previously
established by Executive Order 13045 and co-chaired by the
Administrator of EPA and the Secretary of Health and Human Services.
We encourage Congress to charge it with identifying the principal
environmental health threats to children and developing national
strategies for addressing them. We further encourage Congress to
establish in law the Executive Order's requirement for periodic
reports about federal research findings and research needs regarding
children's environmental health.
Agency Comments and Our Evaluation:
We provided EPA with a draft of this report for review and comment.
EPA stated that the report accurately portrays the agency's challenges
in addressing children's environmental health, and sets forth sound
recommendations on steps that could be taken to better incorporate
protection of children's health as an integral part of EPA's everyday
business. EPA also commented that implementing the recommendations
provided in this report will bring the agency a long way to achieving
its goals for protecting children's health. EPA's written comments are
in appendix V. In addition, EPA provided technical comments, which we
incorporated into the report as appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from its issuance. At that time, we will send copies of this report to
interested congressional committees, the Administrator of the
Environmental Protection Agency, and other interested parties. The
report also will be available at no charge on GAO's Web site at
[hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact me at (202) 512-3841 or stephensonj@gao.gov. Contact points
for our Offices of Congressional Relations and Public Affairs may be
found on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix VI.
Signed by:
John B. Stephenson:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Scope and Methodology:
Our report objectives were to examine (1) the extent to which the
Environmental Protection Agency's (EPA) policies, plans, and guidance
have served to institutionalize the agency's consideration of
children's environmental health; (2) the extent to which EPA has
utilized its children's health office and other child-focused
resources; and (3) what opportunities exist for EPA to provide
national leadership in addressing current and emerging environmental
risks to children's health.
To address our first objective, we obtained and analyzed key EPA
children's health-related policies, strategic and performance plans,
guidance documents, and selected children's indicator reports, and
referred to long-established quality management criteria from the
Government Performance Results Act. We considered EPA's "2006-2011
Strategic Plan: Charting Our Course," "2003-2008 Strategic Plan:
Direction for the Future," "EPA Strategic Plan: 2000-2005," "EPA
Strategic Plan: 1997-2003," as well as EPA's forthcoming strategic
plan, "2009-2013 Strategic Plan: Change Document," which was in draft
form at the time of our review. We analyzed the goals, objectives, and
strategic targets of these documents in order to determine the extent
that they address children's health. We reviewed EPA's performance and
accountability reports to identify performance measures associated
with identified children's health objectives and strategic targets. We
discussed the plans and reports with officials from EPA's Office of
the Chief Financial Officer, including staff from the Office of
Planning, Analysis, and Accountability. We also reviewed OMB Circular
No. A-11 on guidance to agencies preparing materials required for
strategic plans and annual program performance reports. We reviewed
EPA Federal Register notices for regulations subject to the regulatory
requirements of the order as well as documents detailing EPA's
rulemaking for its National Ambient Air Quality Standards for
Particulate Matter published in October 2006. We also reviewed
children's health data that EPA maintains in its regulatory tracking
database.
To address our second objective, we used NVivo, a content analysis
software package, to analyze 35 Advisory Committee meeting agendas and
related summaries derived from meetings held bi-or tri-annually
between December 1997 and July 2009. Content analysis is a methodology
for structuring and analyzing written material. We also used the
software to analyze 74 Children's Health Protection Advisory Committee
(Advisory Committee) letters sent to EPA and 53 EPA response letters,
issued between May 1998 and December 2008. Our internal team of
subject matter and methodological experts developed a coding scheme
for identifying (1) recommendations, which we defined as any and all
statements made in Advisory Committee letters that advise, ask,
request, suggest, or urge EPA to take action; and (2) EPA requests of
the Advisory Committee, which we defined as formal or incidental
requests for advice or input by EPA to its Advisory Committee.
Recommendations were identified in Advisory Committee letters sent to
EPA. In some cases, a single sentence contained multiple
recommendations. For example, the Advisory Committee wrote "EPA should
show leadership in applying stringent mercury controls in our own coal-
fired power plants and involve the U.S. in technology transfer to
improve emissions in other parts of the world," which we coded as two
recommendations. EPA requests of the Advisory Committee were
identified in meeting summaries, which represent the official and
complete record of proceedings. Other requests--for example,
individually from an EPA official to an individual Advisory Committee
member--were not considered requests as the entire Advisory Committee
must be informed and consensus must be reached by the Advisory
Committee on all matters, as specified in its charter.
To characterize the range of issues recommended to EPA by its Advisory
Committee, we developed content analysis categories based on a review
of the Advisory Committee's charter and an initial review of the
letters. We then coded each recommendation into one or more of the
following 10 categories:
* budget and resources (financing, funding, or the need to change
resource levels for a program or issue),
* education and public awareness (providing information to the public
through different media outlets),
* organization and processes (how EPA is organized, including how it
operates, the form or function of EPA management, and its internal
processes and procedures),
* policies and priorities (advising EPA to amend, go forward with, or
cease a particular policy or prioritization that directly or
indirectly may impact children's health),
* external partnership and inter-agency coordination (how EPA
coordinates or collaborates with other agencies or entities),
* guidance (developing, updating and using guidance documents and
related information resources),
* regulations and standards (EPA regulations and its work setting or
influencing EPA or government-wide standards),
* research (conducting, funding, utilizing, or prioritizing research
that would benefit children's health),
* risk assessment (development of risk assessment protocols, and
selecting assumptions, risk factors, and margins of error), and:
* tracking and indicators (tracking environmental pollutants, as well
as monitoring such pollutants and/or observing human health outcomes
over time).
The content analysis was conducted by two analysts, and discrepancies
in coding were discussed and agreement reached between the analysts,
or resolved through a third analyst review. Our analysis produced an
inventory of Advisory Committee recommendations and EPA requests of
the Advisory Committee.
We also interviewed officials from EPA program offices most directly
involved with children's health issues: the Office of Children's
Health Protection, including current and former office directors; the
Office of Research and Development; the Office of Pesticide Programs;
and the Office of Policy, Economics and Innovation. We interviewed
EPA's regional children's environmental health coordinators and lead
regional coordinator within the Office of the Administrator. To gain
further perspective on EPA's use of its children's health-focused
resources, we interviewed leading children's health research and
policy experts at nonprofit organizations and academic institutions,
including those associated with EPA's Advisory Committee.
To address our third objective, we reviewed the annual reports from
the Federal Interagency Forum on Child and Family Statistics to
determine the extent of EPA's involvement in their development. We
also interviewed staff involved with the children's task force and
reviewed documents from the Task Force on Environmental Health Risks
and Safety Risks to Children, including the strategy documents that
were developed. We also reviewed documents related to the G8 Miami
Declaration on Children's Environmental Health, including the 2002
Status Report on Implementation of the 1997 Declaration of the
Environmental Leaders of the Eight on Children's Environmental Health.
We conducted this performance audit from November 2008 through January
2010 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
[End of section]
Appendix II: EPA Policy on Evaluating Health Risks to Children:
United States Environmental Protection Agency:
Office of the Administrator:
Washington, DC 20460:
October 20, 1995:
Memorandum:
Subject: New Policy on Evaluating Health Risks to Children:
To: Assistant Administrators:
General Counsel:
Inspector General:
Associate Administrators:
Regional Administrators:
We are establishing a new Agency-wide policy (attached) that will, for
the first time, ensure that we consistently and explicitly evaluate
environmental health risks of infants and children in all of the risk
assessments, risk characterizations, and environmental and public
health standards that we set for the nation.
This is not a new idea to the many programs throughout the Agency that
currently consider children's health issues in assessing overall risk.
This is, however, a major step forward in establishing a consistent
nationwide children's environmental health policy. We know that
children have a greater potential for exposure to environmental
hazards and our assessments of health risks do not always fully take
into account the potential effects on this vulnerable population. The
National Academy of Sciences has called for policy changes to reflect
children's health factors in evaluating environmental risks.
Our new policy answers that call for change and, in doing so, will
allow us to make better public health decisions that reflect not just
data on adults, but on children whenever possible. By making children
a health priority, we expect that this policy will encourage new, much-
needed research to provide the child-specific data we will need to
thoroughly evaluate the health risks children and infants face from
pollution in our air, land, and water. In the long run, healthier
children mean healthier adults - a great benefit for the nation.
The policy set forth in this memorandum takes effect November 1, 1995,
and is sponsored by the Agency's Science Policy Council, which is
charged with evaluating science policy issues of Agency-wide
importance. We are confident that each of your offices will work with
the Council to ensure a smooth transition to this new policy that is
so important to our nation's future.
Carol M. Browner:
Administrator:
Fred Hansen:
Deputy Administrator:
Attachment:
[End of memorandum]
Policy on Evaluating Health Risks to Children:
Policy:
It is the policy[Footnote 1] of the U.S. Environmental Protection
Agency (EPA) to consider the risks to infants and children
consistently and explicitly as a part of risk assessments generated
during its decision making process, including the setting of standards
to protect public health and the environment. To the degree permitted
by available data in each case, the Agency will develop a separate
assessment of risks to infants and children or state clearly why this
is not done - for example, a demonstration that infants and children
are not expected to be exposed to the stressor under examination.
Background:
When it comes to their health and development, children are not little
adults. This maxim has long been understood in the medical community.
Documentation of the similarities and differences between children and
adults is an integral part of assessing the effects and efficacy of
drugs, for example. The National Academy of Sciences has pointed out
on more than one occasion.[Footnote 2,3] that the maxim should hold
true with respect to exposure to environmental pollutants, as well.
Children may be more or less sensitive than adults when confronted
with an equivalent level of exposure to an environmental pollutant. In
many cases, their responses are substantially different -
qualitatively and quantitatively - from those exhibited by adults.
These age-related variations in susceptibility are due to many
factors, including differences in pharmacokinetics, pharmacodynamics,
body composition, and maturity of biochemical and physiological
functions (for example, metabolic rates and pathways).
In addition, there are often age-related differences in types and
levels of exposure. For example, it is known that infants and children
differ from adults both qualitatively and quantitatively in their
exposures to pesticides in foods. Children eat more food and drink
more water per unit of body weight, and the variety of the food they
consume is more limited than adults. Children also breathe more
rapidly than adults and can inhale more of an air pollutant per pound
of body weight than adults. Children's skin and other body tissues may
absorb some harmful substances more easily. Children's bodies are not
yet fully developed, so exposure to toxic substances may affect their
growth and development. Infants' immune systems are not as strong as
those of healthy adults, so they are less able to fight off emerging
microbial threats such as Cryptosporidium in drinking water.
The Agency is particularly concerned about safeguarding the health of
infants and children, who are among the nation's most fragile and
vulnerable populations. Therefore, it is important that there be a
clear articulation of policy in this regard.
Implementation:
The policy already is currently being followed in many Programs and
regions. The entire Agency will expand implementation activities
during the Fall of 1995 as part of the overall implementation of the
Administrators policy on risk characterization. Other related
activities and sources of information include the presentation of
relevant data in the revised draft Exposure Factors Handbook and
current EPA solicitations of grant proposals for independent studies
on risk to children from exposure to a wide range of substances. EPA's
1991 Guidelines for Developmental Toxicity Risk Assessment are also
relevant.
This policy is not retroactive; it will apply only to those
assessments started or revised on or after November 1, 1995. Any
questions relating to the policy and its implementation should be
referred to Dr. Dorothy Patton, Executive Director of the Agency's
Science Policy Council. She can be reached at 202-260-6600.
Footnotes:
[1] This document is a statement of Agency policy and does not
constitute a rules It is not intended, nor can it be relied upon, to
create any rights enforceable by any party in litigation with the
United States.
[2] National Research Council. 1993. Pesticides in the Diets of
Infants and Children. National Academy of Sciences Press, Washington,
DC.
[3] National Research Council. 1994. Science and Judgment in Kisk
Assessment. National Academy of Sciences Press, Washington, DC.
[End of section]
Appendix III: Executive Order 13045 and Amendments:
19885:
Federal Register:
Vol. 62, No. 78:
Wednesday, April 23, 1997:
Presidential Documents:
Title 3: Executive Order 13045 of April 21, 1997:
The President:
Protection of Children From Environmental Health Risks and Safety Risks
By the authority vested in me as President by the Constitution and the
laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy.
lA 01. A growing body of scientific knowledge demonstrates that
children may suffer disproportionately from environmental health risks
and safety risks. These risks arise because: children's neurological,
immunological, digestive, and other bodily systems are still
developing; children eat more food. drink more fluids, and breathe
more air in proportion to their body weight than adults: children's
size and weight may diminish their protection from standard safety
features; and children's behavior patterns may make them more
susceptible to accidents because they are less able to protect
themselves. Therefore, to the extent permitted by law and appropriate,
and consistent with the agency's mission, each Federal agency:
(a) shall make it a high priority to identify and assess environmental
health risks and safety risks that may disproportionately affect
children; and;
(b) shall ensure that its policies, programs, activities, and
standards address disproportionate risks to children that result from
environmental health risks or safety risks.
1-102. Each independent regulatory agency is encouraged to participate
in the implementation of this order and comply with its provisions.
Sec. 2. Definitions. The following definitions shall apply to this
order.
2-201. "Federal agency" means any authority of the United States that
is an agency under 44 U.S.C. 3502(1) other than those considered to be
independent regulatory agencies under 44 U.S.C. 3502(5). For purposes
of this order, "military departments:' as defined in 5 U.S.C. 102, are
covered under the auspices of the Department of Defense.
2-202. "Covered regulatory action" means any substantive action in a
rule-making, initiated after the date of this order or for which a
Notice of Proposed Rulemaking is published 1 year after the date of
this order, that is likely to result in a rule that may:
(a) be "economically significant" under Executive Order 12866 (a rule-
making that has an annual effect on the economy of $100 million or
more or would adversely affect in a material way the economy, a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State. local, or tribal governments or
communities); and;
(b) concern an environmental health risk or safety risk that an agency
has reason to believe may disproportionately affect children.
2-203. "Environmental health risks and safety risks" mean risks to
health or to safety that are attributable to products or substances
that the child is likely to come in contact with or ingest (such as
the air we breath, the food we eat, the water we drink or use for
recreation, the soil we live on, and the products we use or arc
exposed to).
Sec. 3. Task Force on Environmental Health Risks and Safety Risks to
Children.
3-301. There is hereby established the Task Force on Environmental
Health Risks and Safety Risks to Children ("Task Force").
3-302. The Task Force will report to the President in consultation
with the Domestic Policy Council, the National Science and Technology
Council, the Council on Environmental Quality, and the Office of
Management and Budget (OMB).
3-303. Membership. The Task Force shall be composed of the:
(a) Secretary of Health and Human Services, who shall serve as a Co-
Chair of the Council;
(b) Administrator of the Environmental Protection Agency, who shall
serve as a Co-Chair of the Council;
(c) Secretary of Education;
(d) Secretary of Labor;
(e) Attorney General;
(I) Secretary of Energy;
(g) Secretary of Housing and Urban Development;
(h) Secretary of Agriculture;
(i) Secretary of Transportation;
(j) Director of the Office of Management and Budget:
(k) Chair of the Council on Environmental Quality; (1) Chair of the
Consumer Product Safety Commission;
(m) Assistant to the President for Economic Policy;
(n) Assistant to the President for Domestic Policy;
(o) Assistant to the President and Director of the Office of Science
and Technology Policy;
(p) Chair of the Council of Economic Advisers; and;
(q) Such other officials of executive departments and agencies as the
President may, from time to time, designate.
Members of the Task Force may delegate their responsibilities under
this order to subordinates.
3-304. Functions. The Task Force shall recommend to the President
Federal strategies for children's environmental health and safety,
within the limits of the Administration's budget. to include the
following elements:
(a) statements of principles, general policy, and targeted annual
priorities to guide the Federal approach to achieving the goals of
this order;
(b) a coordinated research agenda for the Federal Government,
including steps to implement the review of research databases
described in section 4 of this order;
(c) recommendations for appropriate partnerships among Federal, State,
local, and tribal governments and the private, academic, and nonprofit
sectors;
(d) proposals to enhance public outreach and communication to assist
families in evaluating risks to children and in making informed
consumer choices;
(e) an identification of high-priority initiatives that the Federal
Government has undertaken or will undertake in advancing protection of
children's environmental health and safety: and;
(f) a statement regarding the desirability of new legislation to
fulfill or promote the purposes of this order.
3-305. The Task Force shall prepare a biennial report on research, data,
or other information that would enhance our ability to understand,
analyze, and respond to environmental health risks and safety risks to
children. For purposes of this report, cabinet agencies and other
agencies identified by the Task Force shall identify and specifically
describe for the Task Force key data needs related to environmental
health risks and safety risks to children that have arisen in the
course of the agency's programs and activities, The Task Force shall
incorporate agency submissions into its report and ensure that this
report is publicly available and widely disseminated. The Office of
Science and Technology Policy and the National Science and Technology
Council shall ensure that this report is fully considered in
establishing research priorities.
3-306. The Task Force shall exist for a period of 4 years from the
first meeting. At least 6 months prior to the expiration of that
period, the member agencies shall assess the need for continuation of
the Task Force or its functions, and make appropriate recommendations
to the President.
Sec. 4. Research Coordination and Integration.
4-401. Within 6 months of the date of this order, the Task Force shall
develop or direct to be developed a review of existing and planned
data resources and a proposed plan for ensuring that researchers and
Federal research agencies have access to information on all research
conducted or funded by the Federal Government that is related to
adverse health risks in children resulting from exposure to
environmental health risks or safety risks. The National Science and
Technology Council shall review the plan.
4-402. The plan shall promote the sharing of information on academic
and private research. It shall include recommendations to encourage
that such data, to the extent permitted by law, is available to the
public, the scientific and academic communities, and all Federal
agencies.
Sec. 5. Agency Environmental health Risk or Safety Risk Regulations.
5-501. For each covered regulatory action submitted to OMB's Office of
Information and Regulatory Affairs (OIRA) for review pursuant to
Executive Order 12866, the issuing agency shall provide to OIRA the
following information developed as part of the agency's decisionmaking
process, unless prohibited by law:
(a) an evaluation of the environmental health or safety effects of the
planned regulation on children; and;
(b) an explanation of why the planned regulation is preferable to
other potentially effective and reasonably feasible alternatives
considered by the agency.
5-502. In emergency situations, or when an agency is obligated by law
to act more quickly than normal review procedures allow, the agency
shall comply with the provisions of this section to the extent
practicable. For those covered regulatory actions that are governed by
a court-imposed or statutory deadline, the agency shall. to the extent
practicable, schedule any rulemaking proceedings so as to permit
sufficient time for completing the analysis required by this section.
5-503. The analysis required by this section may be included as part
of any other required analysis, and shall be made part of the
administrative record for the covered regulatory action or otherwise
made available to the public, to the extent permitted by law.
Sec. 6. Interagency Forum on Child and Family Statistics.
6-601. The Director of the OMB ("Director") shall convene an
Interagency Forum on Child and Family Statistics ("Forum"), which will
include representatives from the appropriate Federal statistics and
research agencies. The Forum shall produce an annual compendium
("Report") of the most important indicators of the well-being of t he
Nation's children.
6-602. The Forum shall determine the indicators to be included in each
Report and identify the sources of data to be used for each indicator.
The Forum shall provide an ongoing review of Federal collection and
dissemination of data on children and families, and shall make
recommendations to improve the coverage and coordination of data
collection and to reduce duplication and overlap.
6-603. The Report shall be published by the Forum in collaboration
with the National Institute of Child Health and Human Development. The
Forum shall present the first annual Report to the President, through
the Director. by July 31, 1997. The Report shall he submitted annually
thereafter, using the most recently available data.
Sec. 7. General Provisions.
7-701. This order is intended only for internal management of the
executive branch. This order is not intended, and should not be
construed to create, any right, benefit, or trust responsibility,
substantive or procedural, enforceable at law or equity by a party
against the United States, its agencies, its officers, or its
employees. This order shall not be construed to create any right to
judicial review involving the compliance or noncompliance with this
order by the United States, its agencies, its officers, or any other
person.
7-702. Executive Order 12606 of September 2, 1987 is revoked.
Signed by:
William J. Clinton:
The White House:
April 21, 1997:
[FR Doc. 97-10695; Filed 4-22-97; 8:49 am]
Billing code 3195-01-P:
[End of document]
Federal Register/Vol. 66, No. 197/Thursday, October 11, 2001/
Presidential Documents: 52013:
Presidential Documents:
Executive Order 13229 of October 9, 2001:
Amendment to Executive Order 13045, Extending the Task Force on
Environmental Health Risks and Safety Risks to Children:
By the authority vested in me as President by the Constitution and the
laws of the United States of America, and in order to extend the Task
Force on Environmental Health Risks and Safety Risks to Children, it
is hereby ordered that Executive Order 13045 of April 21, 1997, is
amended by deleting in section 3-306 of that order "for a period of 4
years from the first meeting" and inserting in lieu thereof "for 6
years from the date of this order".
Signed by:
George W. Bush:
The White House:
October 9, 2001:
[FR Doc. 01-25788; Filed 10-10-01; 8:59 am}
Billing code 3159-01-P:
[End of document]
19931:
Federal Register:
Vol. 68, No. 78:
Wednesday, April 23, 2003:
Presidential Documents:
Title 3: Executive Order 13296 of April 10,2003:
The President:
Amendments to Executive Order 13045, Protection of Children From
Environmental Health Risks and Safety Risks:
By the authority vested in me as President by the Constitution and the
laws of the United States of America, and in order to extend the Task
Force on Environmental Health Risks and Safety Risks to Children, and
for other purposes, it is hereby ordered that Executive Order 13045 of
April 21,1997, as amended, is further amended as follows:
Section 1. Subsection 3-303(o) is amended by striking "Assistant to
the President and".
Sec. 2. Section 3-305 is amended by,
(a) striking "cabinet agencies and other agencies identified" and
inserting in lieu thereof "executive departments, the Environmental
Protection Agency, and other agencies identified"; and;
(b) inserting the following new language after the second sentence:
"Each report shall also detail the accomplishments of the Task Force
from the date of the preceding report."
Sec. 3. Section 3-306 is amended by:
(a) striking "6 years" and inserting in lieu thereof "8 years"; and;
(h) striking the second sentence.
Sec. 4. Section 6-601, the second sentence, is amended by deleting "an
annual" and inserting "a biennial" in lieu thereof.
Sec. 5. Section 6-603, the third sentence, is amended by deleting
"submitted annually" and inserting "published biennially" in lieu
thereof.
Sec. 6. Section 7 is amended by adding new section 7-703 as follows:
"7-703. Nothing in this order shall be construed to impair or
otherwise affect the functions of the Director of the Office of
Management and Budget relating to budget, administrative, or
legislative proposals."
Signed by:
George W. Bush:
The White House:
April 18, 2003:
[FR Doc. 03-10194; Filed 4-22-03, 8:45 am]
Billing code 3195-01—P:
[End of document]
[End of section]
Appendix IV: EPA Regulations Subject to Executive Order 13045:
Executive Order 13045--Protection of Children from Environmental
Health Risks and Safety Risks (Executive Order)--requires that federal
agencies provide, to the Office of Management and Budget (OMB) and in
the public record, (1) an evaluation of the environmental health or
safety effects of the planned regulation on children, and (2) an
explanation of why the planned regulation is preferable to other
potentially effective and reasonably feasible alternatives considered
by the agency.[Footnote 66] Table 6 summarizes the Federal Register
notice preamble section pertaining to the Executive Order for each of
the EPA regulations subject to the Executive Order. The table's
columns show (1) the office that initiated the rulemaking; (2) whether
a given regulation was final or proposed, and its Federal Register
citation; (3) the children's environmental health concern(s) EPA
identified; and (4 and 5) summaries of how EPA described, in the
preamble, its analyses pursuant to the two regulatory requirements of
the Executive Order. The table indicates with an arrow when EPA
explicitly directed readers to additional information in the body of
the rulemaking or the public docket. The table also indicates with a
star when EPA either quantified the effects on children of the
regulation or other regulatory options, or explained why it did not do
so.
We identified 17 rulemakings since 1998 that EPA determined were
subject to the Executive Order's requirements. For each of those
regulations, we analyzed whether and how EPA discussed how it met the
order's requirements in the notice's preamble. We found that EPA has
not consistently documented therein how its rulemakings considered
children's environmental health risks. Specifically, we found that,
for only 4 of the rulemakings did EPA either quantify the effects of
the rulemaking on children or explain why it did not, or could not, do
so. For 8 of the rulemakings, EPA explicitly directed the reader--with
varying degrees of specificity--to additional information about the
regulation's effect on children.
Table 6: EPA Regulations Subject to Executive Order 13045:
1. National Primary Drinking Water Regulations: Long Term 2 Enhanced
Surface Water Treatment Rule:
EPA office: Water;
Type of regulation (date): Final; 71 Fed. Reg. 654 (Jan. 5, 2006);
Effect on children of planned regulation: Cryptosporidiosis from
exposure to Cryptosporidium in drinking water; Common symptoms include
diarrhea and vomiting. EPA described studies on children's unique
susceptibilities and exposures to Cryptosporidium and analyzed data on
the number of Cryptosporidium cases in 1999, by age; (arrow);
Why regulation is preferable to other options: EPA stated that the
planned regulation will reduce the risk of illness for the entire
population, including children. Because children may be
disproportionately affected, the regulation may result in greater risk
reduction for children. Existing data are not adequate to assess
children's risks; (arrow, star);
National Primary Drinking Water Regulations: EPA briefly described
other regulatory options it considered and stated that the planned
regulation was selected because it was deemed feasible and provided
significant public health benefits in terms of avoided illnesses and
deaths. EPA's analysis indicated that the planned regulation ranks
highly among those evaluated with respect to maximizing net benefits.
(arrow).
EPA office: Water;
Type of regulation (date): 68 Fed. Reg. 47,640 (Aug. 11, 2003);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: Same; (arrow, star);
Why regulation is preferable to other options: Same; (arrow).
2. National Pollutant Discharge Elimination System Permit Regulation
and Effluent Limitation Guidelines and Standards for Concentrated
Animal Feeding Operations (CAFO):
EPA office: Water;
Type of regulation (date): Final; 68 Fed. Reg. 7,176 (Feb. 12, 2003);
Children's environmental health concern: Infants under 6 months may be
at risk of methemoglobinemia from exposure to nitrates in private
drinking-water wells; (arrow);
Effect on children of planned regulation: EPA estimated that 112,000
households would have their nitrate levels brought to levels that are
safe for infants. EPA did not have information on the number of
infants living in those households; (arrow, star);
Why regulation is preferable to other options: EPA estimated that more
stringent options would provide only small changes in pollutant
loadings to groundwater, such that more stringent options would not
provide meaningful protection of children's health risks from
methemoglobinemia (arrow).
EPA office: Water;
Type of regulation (date): Proposed; 66 Fed. Reg. 2,960 (Jan. 12,
2001);
Children's environmental health concern: Same; In addition, EPA stated
that information was not available on the actual number of cases of
methemoglobinemia. Furthermore, EPA noted that the following
pollutants may also have a disproportionate risk to children:
pathogens; trace metals such as zinc, arsenic, copper, and selenium;
pesticides; hormones; and endocrine disruptors. However, EPA did not
have adequate information to assess the risks to children; (arrow);
Effect on children of planned regulation: EPA estimated the number of
households that would have their nitrate levels brought to levels that
are safe for infants at 166,000 households under the two-tier
structure; and 161,000 households under the three-tier structure;
(arrow, star);
Why regulation is preferable to other options: Same (arrow).
3. National Ambient Air Quality Standards for Lead:
EPA office: Air and Radiation;
Type of regulation (date): Final; 73 Fed. Reg. 66,964 (Nov. 12, 2008);
Neurological effects from childhood exposure to lead; (arrow);
Children's environmental health concern: EPA stated that the standards
were designed to protect public health with an adequate margin of
safety, as required by the Clean Air Act, and that the protection
offered by the standards may be especially important for children;
Why regulation is preferable to other options: Not explicitly
addressed.
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 73 Fed. Reg. 29,184 (May 20,
2008);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: Same;
Why regulation is preferable to other options: Same.
4. Control of Emissions of Air Pollution From Locomotive Engines and
Marine Compression-Ignition Engines Less Than 30 Liters per
Cylinder[A]:
EPA office: Air and Radiation;
Type of regulation (date): Final; 73 Fed. Reg. 25,098 (May 6, 2008);
Children's environmental health concern: Not specified; EPA stated
that children appeared to be overrepresented for some individual
facilities, based on initial screening conducted by the agency and
described in this section; (arrow);
Effect on children of planned regulation: EPA stated that the
rulemaking would achieve significant reductions of various emissions
from locomotive and marine diesel engines, and that the regulation
would benefit children; (arrow);
Why regulation is preferable to other options: EPA stated that it had
evaluated several regulatory strategies and selected the most
stringent and effective control reasonably feasible, in light of the
technology and cost requirements of the Clean Air Act.
5. National Ambient Air Quality Standards for Ozone:
EPA office: Air and Radiation;
Type of regulation (date): Final; 73 Fed. Reg. 16,436 (Mar. 27, 2008);
Children's environmental health concern: Not specified; (arrow);
Effect on children of planned regulation: Not explicitly addressed;
Why regulation is preferable to other options: Not explicitly
addressed.
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 72 Fed. Reg. 37,818 (Jul. 11,
2007);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: EPA stated that the
standards were designed to protect public health with an adequate
margin of safety, as required by the Clean Air Act, and that the
protection offered by the standards may be especially important for
children;
Why regulation is preferable to other options: Same.
6. Control of Hazardous Air Pollutants From Mobile Sources:
EPA office: Air and Radiation;
Type of regulation (date): Final; 72 Fed. Reg. 8,428 (Feb. 26, 2007);
Children's environmental health concern: Cancer and respiratory
problems from exposure to hazardous air pollutants from mobile
sources, including particulate matter; (arrow);
Effect on children of planned regulation: Not explicitly addressed;
Why regulation is preferable to other options: Not explicitly
addressed.
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 71 Fed. Reg. 15,804 (Mar. 29,
2006);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: EPA stated that the
regulation may have a disproportionately beneficial effect on children;
Why regulation is preferable to other options: Same.
7. Clean Air Fine Particle Implementation Rule[B]:
EPA office: Air and Radiation;
Type of regulation (date): Final; 72 Fed. Reg. 20,586 (Apr. 25, 2007);
Children's environmental health concern: Not specified; (arrow};
Effect on children of planned regulation: EPA stated that the
standards implemented the previously promulgated National Ambient Air
Quality Standards (NAAQS) for fine particulate matter, which were
designed to protect public health with an adequate margin of safety,
as required by the Clean Air Act, and that the protections offered by
the standards may be especially important for children;
Why regulation is preferable to other options: Not explicitly
addressed.
8. National Ambient Air Quality Standards for Particulate Matter:
EPA office: Air and Radiation;
Type of regulation (date): Final; 71 Fed. Reg. 61,144 (Oct. 17, 2006);
Children's environmental health concern: Not specified; (arrow);
Effect on children of planned regulation: EPA stated that the
standards were designed to protect public health with an adequate
margin of safety, as required by the Clean Air Act, and that the
protection offered by the standards may be especially important for
children;
Why regulation is preferable to other options: Not explicitly
addressed.
9. Standards of Performance for New and Existing Stationary Sources:
Electric Utility Steam Generating Units:
EPA office: Air and Radiation;
Type of regulation (date): Final; 70 Fed. Reg. 28,606 (May 18, 2005);
Children's environmental health concern: Neurodevelopmental effects to
developing fetuses from exposure to methylmercury; (arrow);
Effect on children of planned regulation: EPA stated that the
regulation would help reduce exposure of women of childbearing age to
methylmercury, and estimated the number of children who will be
exposed to methylmercury in 2020. EPA estimated how IQ decrements
would be reduced as a result of the regulation.
EPA also discussed limitations of the regulation to affect human
health; (arrow; star);
Why regulation is preferable to other options: EPA stated the selected
option delivered about the same amount of benefits as other regulatory
alternatives it considered, but at a lower cost.
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 69 Fed. Reg. 4,652 (Jan. 30,
2004);
Children's environmental health concern: Not specified;
Effect on children of planned regulation: EPA stated that the
strategies proposed in this rulemaking would improve air quality and
children's health;
Why regulation is preferable to other options: Not explicitly
addressed (arrow).
10. Revision of December 2000 Clean Air Act Section 112(n) Finding
Regarding Electric Utility Steam Generating Units; and Standards of
Performance for New and Existing Electric Utility Steam Generating
Units: Reconsideration[C]:
EPA office: Air and Radiation;
Type of regulation (date): Final; 71 Fed. Reg. 33,388 (Jun. 9, 2006);
Children's environmental health concern: Not specified;
Effect on children of planned regulation: EPA explained that it had
evaluated the environmental health or safety effects to children of
its Clean Air Mercury Rule; (arrow);
Why regulation is preferable to other options: Not explicitly
addressed.
11. Control of Air Pollution from New Motor Vehicles: Heavy-Duty
Engine and Vehicle Standards and Highway Diesel Fuel Sulfur Control
Requirements:
EPA office: Air and Radiation;
Type of regulation (date): Final; 66 Fed. Reg. 5,002 (Jan. 18, 2001);
Children's environmental health concern: Not specified; EPA noted that
some of pollutants addressed in the regulation may disproportionately
affect children's health, such as ozone, particulate matter and
certain toxic air pollutants; (arrow);
Effect on children of planned regulation: EPA stated that the
rulemaking would reduce air toxics and the related impacts on
children's health. Explained that EPA had addressed the effect on
children of exposure to ozone and particulate matter in its
rulemakings to establish the NAAQS for those pollutants, and that it
was not revisiting those here; (arrow);
Why regulation is preferable to other options: EPA stated that,
consistent with the Clean Air Act, the planned regulation was designed
to achieve the greatest degree of reduction of emissions achievable
through available technology, taking cost and other factors into
consideration. (arrow).
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 65 Fed. Reg. 35,430 (June 2,
2000);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: Same; (arrow);
Why regulation is preferable to other options: Same. (arrow).
12. Control of Emissions of Air Pollution from 2004 and Later Model
Year Heavy-Duty Highway Engines and Vehicles; Revision of Light-Duty
On-Board Diagnostics Requirements:
EPA office: Air and Radiation;
Type of regulation (date): Final; 65 Fed. Reg. 59,896 (Oct. 6, 2000);
Children's environmental health concern: Not specified; EPA noted that
some pollutants addressed in the regulation may disproportionately
affect children's health, such as ozone, particulate matter and
certain toxic air pollutants; (arrow);
Effect on children of planned regulation: EPA stated that the
rulemaking would reduce air toxics and the related impacts on
children's health; Explained that EPA had addressed the effect on
children of exposure to ozone and particulate matter in its
rulemakings to establish the NAAQS for those pollutants, and that it
was not revisiting those here; (arrow);
Why regulation is preferable to other options: EPA stated that,
consistent with the Clean Air Act, the planned regulation was designed
to achieve the greatest degree of reduction of emissions achievable
through available technology, taking cost and other factors into
consideration. (arrow).
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 64 Fed. Reg. 58,472 (Oct. 29,
1999);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: Same; (arrow);
Why regulation is preferable to other options: Same. (arrow).
13. Control of Air Pollution From New Motor Vehicles: Tier 2 Motor
Vehicle Emissions Standards and Gasoline Sulfur Control Requirements:
EPA office: Air and Radiation;
Type of regulation (date): Final; 65 Fed. Reg. 6,698 (Feb. 10, 2000);
Children's environmental health concern: Not specified; EPA noted that
some of pollutants addressed in the regulation may disproportionately
affect children's health, such as ozone, particulate matter and
certain toxic air pollutants; (arrow);
Effect on children of planned regulation: EPA stated that the
rulemaking would reduce air toxics and the related impacts on
children's health; (arrow);
Why regulation is preferable to other options: EPA stated that the
planned regulation was the most stringent and effective control
reasonably feasible at the time, in light of the technology and cost
requirements of the Clean Air Act. (arrow).
EPA office: Air and Radiation;
Type of regulation (date): Proposed; 64 Fed. Reg. 26,004 (May 13,
1999);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: Same; (arrow);
Why regulation is preferable to other options: Same. (arrow).
14. Lead; Renovation, Repair, and Painting Program.
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Final; 73 Fed. Reg. 21,692 (Apr. 22, 2008);
Children's environmental health concern: Not specified; (arrow);
Effect on children of planned regulation: EPA stated that the primary
purpose of the regulation was to minimize exposure in children under
age 6 to lead-based paint hazards created during renovation, repair,
and painting activities in housing or other buildings. Estimated that
the regulation would affect 1.4 million children under age 6,
providing considerable benefits to those children; (star);
Why regulation is preferable to other options: Not explicitly
addressed.
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Proposed; 71 Fed. Reg. 1,588 (Jan. 10,
2006);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: EPA stated that one purpose
of the proposed regulation was to prevent the creation of new lead-
based paint hazards from housing where children under age 6 reside.
Estimated that the regulation would affect 1.1 million children under
age 6, providing considerable benefits to those children; (star);
Why regulation is preferable to other options: Same.
15. Lead and Lead Compounds; Lowering of Reporting Thresholds;
Community Right-to-Know Toxic Chemical Release Reporting:
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Final; 66 Fed. Reg. 4,500 (Jan. 17, 2001);
Children's environmental health concern: Not specified; EPA stated
that it identified and assessed the environmental health risks and
safety risks that may disproportionately affect children;
Effect on children of planned regulation: EPA described how the
informational benefits of the planned regulation could positively
impact children and other populations;
Why regulation is preferable to other options: Not explicitly
addressed.
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Proposed; 64 Fed. Reg. 42,222 (Aug. 3,
1999);
Children's environmental health concern: Same;
Effect on children of planned regulation: Same;
Why regulation is preferable to other options: Same.
16, Lead; Identification of Dangerous Levels of Lead:
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Final; 66 Fed. Reg. 1,206 (Jan. 5, 2001);
Children's environmental health concern: Not specified; (arrow);
Effect on children of planned regulation: EPA stated that the selected
standards were designed first and foremost to protect children from
lead in residential paint, dust, and soil;
Why regulation is preferable to other options: EPA stated that it
could have selected numerically more stringent standards, but
concluded that they would provide less protection to children because
limited resources would be diluted and possibly diverted away from
children at greatest risk.
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Proposed; 63 Fed. Reg. 30,302 (Jun. 3,
1998);
Children's environmental health concern: Same; (arrow);
Effect on children of planned regulation: EPA stated that young
children were the primary beneficiaries of the proposed regulation
because exposure to lead, paint, and dust is mostly limited to
children under the age of 6;
Why regulation is preferable to other options: Not explicitly
addressed.
17. Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering of
Reporting Thresholds for Certain PBT Chemicals; Addition of Certain
PBT Chemicals; Community Right-to-Know Toxic Chemical Reporting:
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Final; 64 Fed. Reg. 58,666 (Oct. 29, 1999);
Children's environmental health concern: Not explicitly addressed;
Effect on children of planned regulation: EPA described how the
informational benefits of the rule could positively impact children
and other populations;
Why regulation is preferable to other options: Not explicitly
addressed.
EPA office: Prevention, Pesticides, and Toxic Substances;
Type of regulation (date): Proposed; 64 Fed. Reg. 688 (Jan. 5, 1999);
Children's environmental health concern: Same;
Effect on children of planned regulation: Same;
Why regulation is preferable to other options: Same.
Source: GAO analysis of Federal Register notices' preamble sections.
Notes:
The table indicates with an arrow (Ü) when EPA explicitly directed
readers to additional information in the body of the rulemaking or the
public docket. The table also indicates with a star (H) when EPA
either quantified the effects on children of the regulation or other
regulatory options, or explained why it did not do so.
[A] EPA determined that the proposed regulation, published April 3,
2007, was not subject to Executive Order 13045 because the agency did
not have reason to believe that the environmental health risks or
safety risks addressed by the regulation presented a disproportionate
risk to children.
[B] EPA determined that the proposed regulation, published November 1,
2005, was not subject to Executive Order 13045. EPA did not explicitly
state in its Federal Register notice why the regulation was not
subject to the order.
[C] This regulation sets forth EPA's decision after reconsidering
certain aspects of the March 29, 2005, final rule entitled "Revision
of December 2000 Regulatory Finding on the Emissions of Hazardous Air
Pollutants From Electric Utility Steam Generating Units and the
Removal of Coal-and Oil-Fired Electric Utility Steam Generating Units
from the Section 112(c) List" (Section 112(n) Revision Rule). The
regulation also includes EPA's final decision regarding
reconsideration of certain issues in the May 18, 2005, final rule
entitled "Standards of Performance for New and Existing Stationary
Sources: Electric Utility Steam Generating Units" (Clean Air Mercury
Rule; CAMR), which was subject to Executive Order 13045.
[End of table]
[End of section]
Appendix VI: Comments from the Environmental Protection Agency:
United States Environmental Protection Agency:
Office of Congressional and Intergovernmental Relations:
Washington, D.C. 20460:
[hyperlink: http://www.epa.gov]
December 22, 2009:
John B. Stephenson:
Director:
Natural Resource & Environment:
United States Government Accountability Office:
441 G Street, NW, Room 2075:
Washington, D.C. 20548:
Dear Mr. Stephenson:
Thank you for the opportunity to review and comment on the draft
report of the Government Accountability Office (GAO), entitled
Environmental Health: High-level Strategy and Leadership Needed to
Continue Progress Toward Protecting Children from Environmental
Threats. Consistent with our comments on the Statement of Facts, the
Environmental Protection Agency (EPA) agrees that the GAO report
reflects well the early history and progress of the Agency's
children's health protection efforts. The report accurately portrays
the Agency's challenges in addressing children's environmental health,
and sets forth sound recommendations on steps that could be taken to
better incorporate protection of children's health as an integral part
of EPA's everyday business.
Offices throughout the Agency continue to implement mandates, develop
regulations, support programs and reach out to communities to protect
children from environmental threats and help prevent illness and
injury. While the Agency has taken important steps to ensure
protection of children's health since the inception of the Office of
Children's Health Protection in 1997, the Administrator is committed
to strengthening these efforts and dedicating resources to bolster our
efforts in children's health protection to bring about more tangible
results in this area. She recently cited protecting children's health
as central to the Agency's mission in an internal memo dated September
11, 2009. Specifically, she noted that "...several goals central to
the environmental mission of this Administration need to be brought
into the regulatory process as early as possible in order to give them
the attention they are due; these are environmental justice,
children's health, and climate change.... With respect to children's
health, early attention to this issue is critical to grasping the full
implications of a regulatory or policy decision for children and to
addressing those implications in the decision-making process."
Implementing the recommendations provided in the GAO report will bring
us a long way to achieving this goal.
GAO recommended that the Agency update and reissue a child-focused
strategy, such as the 1996 national agenda, to articulate current
national environmental health priorities and emerging issues. While
the National Agenda has served as a valuable guide for leadership on
children's environmental health, it is timely to conduct an evaluation
of the National Agenda and determine if revision, reaffirmation, or
reissuance is needed. The Agency's 2009 five point agenda for
children's environmental health is a beginning for this work and is
consistent with the National Agenda.
GAO 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. Already, in the past six months, EPA has reviewed its Rule
and Policy Information Development System (RAPIDS) and is enhancing it
to collect more targeted information regarding effects on children's
health. Specifically, programs are now asked to provide information on
whether a rule is likely to address an adverse impact on childhood
life-stages and the nature of that impact. Using this information, the
Office of Children's Health Protection and Environmental Education is
identifying rules on which to focus its attention. Additionally, EPA
is in the process of establishing "the Rulemaking Gateway," a new,
publicly accessible interface to our data system that provides more
user friendly information on child health impacts resulting from our
priority rulemakings.
GAO recommends that the Agency reevaluate the 1995 policy to ensure
its consistency with new scientific research demonstrating the risks
childhood exposures can have on risks for disease in later lifestages.
The Agency will reevaluate the 1995 policy as part of a broader effort
to implement science policies that are adequately protective of
children's environmental health. Such review is critically important
since, as a regulatory agency, risk assessment policies are core to
how we apply science to protect human health.
GAO recommends that the Agency's 2009-2013 strategic plan expressly
articulate children specific goals, objectives and targets. The
strategic plan is currently under development. We will ensure that it
reflects the Administrator's priorities, including children's
environmental health.
GAO recommends that the Agency reevaluate the mission of the Office of
Children's Health Protection and its director to make the office an
agencywide champion for implementation of a reissued national
children's environmental health agenda, policy, and related goals in
the next EPA strategic plan. The Agency is currently implementing this
recommendation through the reorganization of the Office of Children's
Health Protection and Environmental Education.
GAO recommends that the Agency establish key children's environmental
health staff within each program office and regional office, with
linkages to the Office of Children's Health, to improve cross-agency
implementation of revised priorities and goals, and ensure
coordination and communication among EPA's program offices. The report
points out the efforts undertaken in the past to do this, including
the establishment of regional children's health coordinators. We will
build upon these efforts to broaden Agency-wide implementation of
programs and policies to protect children's health.
GAO recommends that EPA use the Children's Health Protection Advisory
Committee proactively as a mechanism for providing advice on
regulations, programs, plans or other issues. The Agency has recently
renewed the charter of the Advisory Committee and is committed to
using the CHPAC to request advice on regulations, policies and other
important environmental issues.
GAO recommends that EPA ensure participation to the 'idlest extent
possible, by the Office of Children's Health or other key officials on
the interagency organizations identified in Executive Order 13045. We
also note with interest the GAO recommendation to Congress on the
reestablishment of the interagency task force. EPA will ensure active
participation from the Office of Children's Health or other key
officials on interagency efforts related to children's environmental
health.
Again, thank you for the opportunity to comment on this draft report.
If you have further questions, please contact me, or your staff may
call Bobbie Trent, the EPA GAO liaison, at (202 566-0983.
Sincerely,
Signed by:
David McIntosh:
Associate Administrator:
[End of section]
Appendix VII: GAO Contact and Staff Acknowledgments:
GAO Contact:
John Stephenson, (202) 512-3841 or stephensonj@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Diane Raynes, Assistant
Director; Elizabeth Beardsley; Timothy Bober; Mark Braza; Emily
Hanawalt; Terrance Horner, Jr.; Aaron Shiffrin; Benjamin Shouse; and
Kiki Theodoropoulos made key contributions to this report.
[End of section]
Footnotes:
[1] The Environmental Protection Agency sets National Ambient Air
Quality Standards for ozone, particulate matter, sulfur dioxide,
nitrogen dioxide, carbon monoxide, and lead.
[2] In 2005, EPA expanded the office to include environmental
education and aging initiatives, renaming it the Office of Children's
Health Protection and Environmental Education.
[3] EPA Office of Inspector General, The Effectiveness of the Office
of Children's Health Protection Cannot Yet Be Determined
Quantitatively, Report No. 2004-P-00016 (Washington, D.C., May 17,
2004).
[4] GAO, Environmental Health: EPA Efforts to Address Children's
Health Issues Need Greater Focus, Direction, and Top-Level Commitment,
[hyperlink, http://www.gao.gov/products/GAO-08-1155T] (Washington,
D.C.: Sept. 16, 2008).
[5] Pub. L. 103-62 (1993).
[6] National Research Council, National Academy of Sciences,
Pesticides in the Diets of Infants and Children (Washington, D.C.,
1993).
[7] The Food Quality Protection Act provisions allowed EPA to use a
different safety factor if the Administrator finds that reliable data
demonstrate it would be safe for infants and children. Pub. L. No. 104-
170 § 405 (1996).
[8] The term "subpopulation" is ingrained into EPA's past practice, as
well as various laws that EPA administers, such as the Safe Drinking
Water Act Amendments (1996). Prior to the publication of the 2005
Guidelines for Carcinogen Risk Assessment and the 2005 Guidance on
Selecting Age Groups for Monitoring and Assessing Childhood Exposures
to Environmental Contaminants, EPA described all types of groups of
individuals as "subpopulations."
[9] Interagency Forum on Child and Family Statistics, America's
Children: Key National Indicators of Well-Being (Washington, D.C.,
2009).
[10] 62 Fed. Reg. 19,885 (Apr. 21, 1997).
[11] [hyperlink, http://www.epa.gov/ncer/childrenscenters].
[12] Pub. L. No. 106-310, § 1004 (2000).
[13] [hyperlink, http://nationalchildrensstudy.gov].
[14] EPA, America's Children and the Environment, [hyperlink,
http://www.epa.gov/economics/children] (accessed Jan. 15, 2010).
[15] EPA, EPA's Action Development Process: Guidance for EPA Staff on
Developing Quality Actions (Washington, D.C., 2004).
[16] Executive Order 12866 directs most agencies, including EPA, to,
among other things, assess costs and benefits of available regulatory
alternatives and to submit significant rules to OMB's Office of
Information and Regulatory Affairs for review before they are
published. 58 Fed. Reg. 51,735 (1993). For a summary of agencies'
responsibilities for rulemakings under broadly applicable
requirements, see appendix I of GAO, Federal Rulemaking: Improvements
Needed to Monitoring and Evaluation of Rules Development as Well as to
the Transparency of OMB's Regulatory Reviews, GAO-09-205 (Washington,
D.C.: Apr. 20, 2009).
[17] EPA, EPA's Action Development Process: Guide to Considering
Children's Health When Developing EPA Actions: Implementing Executive
Order 13045 and EPA's Policy on Evaluating Health Risks to Children
(Washington, D.C., 2006).
[18] P.L. 106-310.
[19] The research strategy has not been updated since its publication.
Instead, EPA integrated children's environmental health into its
Office of Research and Development multiyear human health research
plans.
[20] EPA Office of Inspector General, Report No. 2004-P-00016.
[21] GAO, Environmental Information: EPA Actions Could Reduce the
Availability of Environmental Information to the Public, [hyperlink,
http://www.gao.gov/products/GAO-07-464T] (Washington, D.C.: Feb. 6,
2007), and Toxic Chemical Releases: EPA Actions Could Reduce
Environmental Information Available to Many Communities, [hyperlink,
http://www.gao.gov/products/-08-128] (Washington, D.C.: Nov. 30, 2007).
[22] Omnibus Appropriations Act, 2009, Pub. L. No. 111-8, § 425 (2009).
[23] Administrator Lisa P. Jackson, Remarks at the Columbia University
Center for Children's Environmental Health, March 30, 2009.
[24] Pub. L. 94-469 (1976); codified as amended at 15 U.S.C. §§ 2601
et seq.
[25] In September 2009, the EPA Administrator announced a five-part
comprehensive approach to enhance chemical management under existing
laws. This approach includes developing chemical action plans, which
should target the agency's risk management efforts on chemicals of
concern, and increasing public access to information about chemicals.
[26] The Government Performance and Results Act requires that each
agency prepare a strategic plan that defines its missions, goals, and
the means by which it will measure its progress over a 5-year period
and update them every 3 years. For example, EPA's 1997 plan covered
years 1997 through 2001.
[27] EPA has issued four strategic plans since 1997, and is currently
in the process of issuing its 2009-2013 plan.
[28] EPA's 2003 and 2006 strategic plans include five goals: (1) Clean
Air and Global Climate Change, (2) Clean and Safe Water, (3) Land
Preservation and Restoration, (4) Healthy Communities and Ecosystems,
and (5) Compliance and Environmental Stewardship.
[29] The draft September 2009 strategic plan includes target areas for
improvement, such as impacts of sustainable agriculture, global
climate change, import safety, and environmental indicators.
[30] OMB defines strategic targets as quantifiable or otherwise
measurable characteristics that tell how well or at what level a
program aspires to perform. Each subobjective typically has between
one and four strategic targets.
[31] GAO, Depot Maintenance: Improved Strategic Planning Needed to
Ensure That Army and Marine Corps Depots Can Meet Future Maintenance
Requirements, [hyperlink, http://www.gao.gov/products/GAO-09-865]
(Washington, D.C.: Sept. 17, 2009).
[32] OMB defines objectives and subobjectives as statements of aim or
purpose included in a strategic plan, required under the Government
Performance and Results Act. EPA's current strategic plan has 9
subobjectives under goal 1, 5 subobjectives under goals 2 and 3, 20
subobjectives under goal 4, and 6 subobjectives under goal 5.
[33] Risk assessment is the process EPA uses to determine the nature
and magnitude of health risks to humans from chemical contaminants and
other stressors.
[34] EPA's Web site explains its lifestages research (see [hyperlink,
http://www.epa.gov/nerl/goals/health/lifestage.html]).
[35] EPA, Board of Scientific Counselors, Review of the Office of
Research and Development's Human Health Research Program at the U.S.
Environmental Protection Agency (Washington, D.C., 2009).
[36] EPA's Office of Pesticide Programs noted that, as a result of the
Food Quality Protection Act of 1996, its risk assessments routinely
discuss the risks to infants and children resulting from use of
pesticides.
[37] EPA, Office of Policy, Economics, and Innovation, EPA's Action
Development Process: Guide to Considering Children's Health When
Developing EPA Actions: Implementing Executive Order 13045 and EPA's
Policy on Evaluating Health Risks to Children (Washington, D.C.,
2006). This guide superseded EPA's Rule Writer's Guide to Executive
Order 13045 (Washington, D.C., 1998).
[38] EPA, Risk Assessment Forum, Supplemental Guidance for Assessing
Susceptibility from Early Life Exposure to Carcinogens (Washington,
D.C., 2005). EPA, Office of Research and Development, Child-Specific
Exposure Factors Handbook (Washington, D.C., 2008).
[39] EPA, Risk Assessment Forum, Guidance on Selecting Age Groups for
Monitoring and Assessing Childhood Exposures to Environmental
Contaminants (Washington, D.C., 2005).
[40] EPA, Office of Children's Health Protection and Office of Policy,
Economics, and Innovation, Children's Health Valuation Handbook
(Washington, D.C., 2003).
[41] According to the Office of Policy, Economics, and Innovation, the
agency conducted final review for 58 tier 1 or tier 2 regulations from
2007 through 2008.
[42] EPA's Office of Research and Development was responsible for
supporting much of the relevant research on particulate matter. More
than 40 percent of the research citations in the Criteria Document and
the Staff Paper, key documents prepared during the action development
process then in effect, were supported by the office, according to EPA
(see figure 2).
[43] American Farm Bureau Federation v. EPA, 559 F. 3d 512, 519 (2009).
[44] Codified as amended at 42 U.S.C. Ch. 85 (2009).
[45] The Executive Order applies to rulemakings that are initiated
after April 21, 1997, or for which a Notice of Proposed Rulemaking is
published after April 21, 1998. EPA did not determine that any
proposed or final regulations published before 1998 were subject to
the order.
[46] National Emission Standards for Hazardous Air Pollutants from the
Portland Cement Manufacturing Industry Proposed Rule, 74 Fed. Reg.
21,136, 21,170 (May 6, 2009).
[47] [hyperlink, http://www.gao.gov/products/GAO-09-205].
[48] Executive Order 12866 also applies to "significant" rulemakings
that meet criteria other than economic significance; however,
Executive Order 13045's regulatory requirements are triggered only by
economic significance.
[49] D. Payne-Sturges and D. Kemp, "Ten Years of Addressing Children's
Health through Regulatory Policy at the U.S. Environmental Protection
Agency." Environmental Health Perspectives, vol. 116, no. 12 (2008).
The study covered the period from April 1998 to December 2006.
[50] Pub. L. No. 104-170, § 405 amended the standard-setting
provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.).
[51] Executive Order 12866 of September 30, 1993, was amended by
Executive Order 13258 of February 26, 2002, and Executive Order 13422
of January 18, 2007, and is still in effect.
[52] Unless otherwise noted, when we refer to Federal Register notices
in this section, we are referring to the preamble section on Executive
Order 13045. The Executive Order requires that, for covered actions,
the agency conduct and submit these analyses to OMB. The analyses must
also be made part of the administrative record or otherwise made
available to the public, to the extent permitted by law. The Executive
Order does not require that the Federal Register notices for such
regulations explain the agency's analyses.
[53] The first Director of the Office of Children's Health served
almost 5 years, from 1997 through 2002. The four subsequent acting
directors, from 2002 to 2008, served an average of 2 years.
[54] EPA Office of Inspector General, The Effectiveness of the Office
of Children's Health Protection Cannot Yet Be Determined
Quantitatively, Report No. 2004-P-00016 (Washington, D.C.: May 17,
2004).
[55] GAO, Management Reform: Elements of Successful Improvement
Initiatives, [hyperlink, http://www.gao.gov/products/GAO/T-GGD-00-26]
(Washington, D.C.: Oct. 15, 1999).
[56] GAO, Diversity Management: Expert-Identified Leading Practices
and Agency Examples, [hyperlink,
http://www.gao.gov/products/GAO-05-90] (Washington, D.C.: Jan. 14,
2005).
[57] Staff positions are measured in full-time-equivalents (FTE),
which generally consists of one or more employed individuals who
collectively complete 2,080 work hours in a given year. For example,
one FTE can represent either one full-time employee or two half-time
employees.
[58] EPA's Inspector General recommended in his 2004 report that
coordination be reflected in EPA's strategic plan objectives and in
relevant output and outcome performance indicators.
[59] [hyperlink, http://www.gao.gov/products/GAO-08-1155T].
[60] For example, we placed the following June 2008 Advisory Committee
recommendation into both the research and the policy and procedure
categories: "Additional research on children's vulnerabilities to
health impacts of climate change should also be a priority for the
agency as a whole in the future."
[61] The forum was founded in 1994 to foster the coordination and
integration of the collection and reporting of data on children and
families.
[62] [hyperlink, http://childstats.gov].
[63] The G8 countries are Canada, France, Germany, Italy, Japan,
Russia, the United Kingdom, the United States, as well as the European
Commission. The most recent meeting of the G8 took place in Italy in
April 2009.
[64] Administrator Lisa P. Jackson, Remarks at the G8 Environmental
Minister's Meeting Children's Health Event, April 24, 2009.
[65] [hyperlink, http://www.gao.gov/products/GAO-08-1155T].
[66] These requirements are provided in Executive Order 13045 section
501(a) and 501(b), respectively.
[End of section]
GAO's Mission:
The Government Accountability Office, the audit, evaluation and
investigative arm of Congress, exists to support Congress in meeting
its constitutional responsibilities and to help improve the performance
and accountability of the federal government for the American people.
GAO examines the use of public funds; evaluates federal programs and
policies; and provides analyses, recommendations, and other assistance
to help Congress make informed oversight, policy, and funding
decisions. GAO's commitment to good government is reflected in its core
values of accountability, integrity, and reliability.
Obtaining Copies of GAO Reports and Testimony:
The fastest and easiest way to obtain copies of GAO documents at no
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each
weekday, GAO posts newly released reports, testimony, and
correspondence on its Web site. To have GAO e-mail you a list of newly
posted products every afternoon, go to [hyperlink, http://www.gao.gov]
and select "E-mail Updates."
Order by Phone:
The price of each GAO publication reflects GAO’s actual cost of
production and distribution and depends on the number of pages in the
publication and whether the publication is printed in color or black and
white. Pricing and ordering information is posted on GAO’s Web site,
[hyperlink, http://www.gao.gov/ordering.htm].
Place orders by calling (202) 512-6000, toll free (866) 801-7077, or
TDD (202) 512-2537.
Orders may be paid for using American Express, Discover Card,
MasterCard, Visa, check, or money order. Call for additional
information.
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]:
E-mail: fraudnet@gao.gov:
Automated answering system: (800) 424-5454 or (202) 512-7470:
Congressional Relations:
Ralph Dawn, Managing Director, dawnr@gao.gov:
(202) 512-4400:
U.S. Government Accountability Office:
441 G Street NW, Room 7125:
Washington, D.C. 20548:
Public Affairs:
Chuck Young, Managing Director, youngc1@gao.gov:
(202) 512-4800:
U.S. Government Accountability Office:
441 G Street NW, Room 7149:
Washington, D.C. 20548: